Lesli G. Ginn Chief Administrative October Mari Robinson, 2016 VIA INTERAGENCY J.D. Executive Director Texas Medical Board 333 Guadalupe, Tower Austin, Texas 78701 RE: 12, Law Judge 111, Suite 610 Docket No. 503-14-1342/Stanislaw R. Burzynski, M.D. ~~ / Dear Ms. Robinson: Pleasefind enclosed a Proposal Code § for Decision in this case. Exceptions and replies may be filed by any party in accordance with 1 Tex. Admin. 155 .507(c), a SOAH rule which may be found at www.soah.state.texas.,qov. Rey Scudday fidmmisu‘afiva Law‘igégg _, _ 4 V ‘ r . Sincerely, CATHERINE c. EGAN ADMINISTRATIVE LA JUDGE STATE OFFICE OF ADMINISTRATIVE HEARINGS . RGS, CCE/et Enclosures xc: Amy Swanholm, Staff Attorney Texas Medical Board 333 VIA INTERAGENCY Guadalupe, Tower 111, Ste. 610, Austin, TX 78701 — Robin Etheridge, Hearings Coordinator, Texas Medical Board, 333 Guadalupe, Tower III, Ste. 610, Austin, TX 78701 (with 3 CDs; Certified Evidentiary Record —Staff‘s Exh. 5 boxes, Resp. Exh. 2 boxes, Transcripts 1 box, Depos. 2 boxes, 1 Envelope with Master List of Exhibits) — VIA INTERAGENCY Melanie Rubinsky, Myers & Doyle, 7676 Woodway, Suite 350, Houston, TX 77063 — VIA REGULAR MAIL J. Gregory Myers, Myers & Doyle, 7676 Woodway, Suite 350, Houston, TX 77063 — VIA REGULAR MAIL Dan Cogdell, The Cogdell Law Firm, PLLC, 402 Main Street, 4th Floor, Houston, TX 77002 — VIA REGULAR MAIL 300 W. 504, Austin, Texas 78701/ PO. Box 13025, Austin, Texas 78711-3025 512.475.4993 (Main) 512.475.3445 (Docketing) 512.475.4994 (Fax) www.soah.texas.gov 15th Street, Suite SOAH DOCKET NO. 503-14-1342.MD TEXAS MEDICAL BOARD, § Petitioner § § § § § § v. .- STANISLAW R. BURZYNSKI, M.D., Respondent BEFORE THE STATE OFFICE OF ADMINISTRATIVE HEARINGS TABLE OF CONTENTS I. JURISDICTION, NOTICE, AND PROCEDURAL HISTORY .......................................... II. BACKGROUND, ALLEGATIONS, AND APPLICABLE LAW A. Background ................................... Dr. Burzynski 1. .. Burzynski Research Institute/Institutional Review Board (BRI/IRB) 3. B. Staff’s Allegations ......... C. Applicable Law 7 . 8 .......................... .............. 4 5 6 Statutory Grounds for Disciplinary Action ............................................... 8 9 .. Board Rules ............ 11 Board Rules Regarding Clinical Investigations ...................................... 12 ...... Aggravating and Mitigating Factors ........ .. 1. 2. 3. 4. III. ........ The Clinic ........ 2. 4 ....................... 4 .. . ...................................... 3 OVERVIEW OF THE EVIDENCE .................................................................................. 12 ........... 12 Evidence ....... A. Staff’s B. Respondent’s Evidence ............................................................................................ 12 C. The Experts ............... Staff’s 1. a. b. c. 2. 13 .. Experts . Dr. Fost ................................ Ms. Kloos Dr. ....... .. . .. Wetmore .......................................... .. . ......... .................................. v 14 14 15 15 Respondent’s Experts ................................................................................ 16 SOAH DOCKET NO. 503-14-1342.MD Dr. Levin Dr. Janicki a. b. IV. ................ .. General Allegations Regarding Patients 2. 3. 5. b. c. d. 2. 3. 4. 5. 2. 3. E. 1. 31 32 B ....................... 38 . ............................................. .. Document May C .................. .. .. 39 40 41 42 42 43 2010 Office Visit ...................................... 43 Inadequate Medical Rationale for Changing Therapy ........................... 44 Unnecessary and Costly Laboratory Testing without Demonstrable 46 Benefit ....................................................... .. Failure to 14, Individual Allegations Regarding Patient 2. A ............... Inadequate Medical Rationale for Using ANP ........................................ Inadequate Medical Rationale for Changing Therapy ........................... Misrepresentations to United States Customs Agents ............................ Unnecessary Oxygen Saturation Measurements ....................... ............. Unnecessary and Costly Laboratory Testing without Demonstrable Individual Allegations Regarding Patient 1. ..... . Benefit D. 19 Inadequate Medical Rationale for Changing Therapy ........................... 33 Unnecessary Oxygen Saturation Measurements .............. ...................... 35 Individual Allegations Regarding Patient 1. ......................................... Inadequate Medical Documentation Individual Allegations Regarding Patient 1. 18 ........ 26 Potential Toxicities of Combined Drugs Inadequate Medical Rationale for Treatment with ANP, PB, and/or the Combined Use of Drugs ................................................. 28 Inadequate Medical Rationale for the Evaluation, Diagnosis, and Treatment of the Patients ................................................................. 29 a. C. A through G . Inadequate Medical Documentation ........................................................ 25 ALJs’ Analysis ............................................... 26 4. 2. .. Potential Toxicities of Combined Drugs .................................................. 19 Inadequate Medical Rationale for Treatment with ANP, PB, and/or the ............................ 22 .. Combined Use of Drugs ...... Inadequate Medical Rationale for the Evaluation, Diagnosis, and ................................ 24 Treatment of the Patients ..... 1. B. 16 18 .. ...................................... STANDARD OF CARE ................................... A. PAGE 2 TABLE OF CONTENTS D . ...... 46 Improper Billing for Dr. Weaver’s Services ............................................ 46 Unnecessary Oxygen Saturation Measurements ..................................... 47 SOAH DOCKET NO. 503-14-1342.MD PAGE 3 TABLE OF CONTENTS Unnecessary and Costly Laboratory Testing without Demonstrable 3. 47 Benefit .................................................. F. Individual Allegations Regarding Patient 2. 3. 4. 5. Benefit ................. 1. 2. H. ‘ 2. 3. ...... .. G ............... 54 . ................... Licensed Providers B. ALJs’ Analysis Regarding Licensed Providers.... C. Unlicensed Practitioners 4. 5. 6. 7. 8. 9. 10. 11. 60 .................. . ........................................................................................... A. 3. 52 Inadequate Medical Rationale for Use and Promotion of ANP ............ 55 Unnecessary Oxygen Saturation Measurements ..................................... 58 59 Improper Billing and Collection Practices PRACTITIONERS 2. 49 50 52 F .......................................................... 52 INADEQUATE DELEGATION AND IMPROPER USE OF UNLICENSED 1. 48 Inadequate Documented Medical Rationale for Valtrex in Treatment 53 Unnecessary Oxygen Saturation Measurements ..................................... 54 Unnecessary and Costly Laboratory Testing without Demonstrable 54 Benefit... ................................... .. Individual Allegations Regarding Patient 1. V. .. Individual Allegations Regarding Patient 3. 47 ........ .. Non-Therapeutically Prescribing Combinations of Two Targeting ............................................................. Agents. .. Inadequate Medical Rationale for Prescribing Multiple Targeting Agents .......................................................................................................... ...... .. Inadequate Informed Consent ............... Unnecessary Oxygen Saturation Measurements ..................................... Unnecessary and Costly Laboratory Testing without Demonstrable 1. G. E Tolib .. 60 ............ 65 ...................... . Rakhmanov .................................................... 67 71 ALJs’ Analysis Regarding Unlicensed Practitioners .............................. 74 Mohammed Khan ...................................................................................... 76 ALJs’ Analysis ............................................................................................ 79 Larisa Tikhomirova .............................................. 80 ALJs’ Analysis ................................ 83 .. Sheryl] Acelar ................................. .. . .......... ALJs’ Analysis ........................... Lourdes DeLeon.. .............. ALJs’ Analysis ......................................... ........ ALJs’ Summary of Analysis ................................ 84 88 89 92 92 SOAH DOCKET NO. 503-14-1342.MD VI. VII. INFORMED CONSENT PAGE 4 TABLE OF CONTENTS .............................................................................. ....................... 93 V A. Concurrent Use of Medications .............................................................................. 94 B. Timeliness of Obtaining Informed Consent ....................... C. Off-label D. Alternative Therapy or Clinical Trials E. Summary of ALJs’ Use of FDA-Approved Drugs 99 102 .......... ............. Analysis ...................... 103 104 .......... . DISCLOSURE OF OWNERSHIP INTEREST IN PHARMACY AND LABORATORY ................................................................ 105 VIII. IMPROPER CHARGES AND RETAINER DEMANDS A. B. C. D. E. F. G. .......................................... 107 Patient A 1. Billings ....................................................................................................... 111 .................................................. .. 111 .......... 2. Summary of ALJ’s Analysis Patient B ............................ .................................. 1. Billings ....................................................................................................... 115 ........ 115 . 1 15 ' 2. Summary of ALJs’ Patient C 1. Billings .............. Analysis .. 122 123 .......... 123 .. 2. Summary of ALJs’Analysis .................................... ................................ 1 27 Patient D 1. Billings ..................................................... I ................................................................................................................. 2. Summary Patient E 1. Billings .............................. of ALJs’ Analysis ......... ................... 127 127 128 128 ...... .......... . 128 132 2. Summary of ALJs’ Patient F ............... 1. Billings ....................................................................................................... 132 2. Summary of ALJs’ Patient G Analysis ........ .. Analysis ...................... ................................................................... ‘ ................. .. .......... 132 134 134 SOAH DOCKET NO. 503-14—1342.MD 1. 2. IX. X. Billings PAGE 5 TABLE OF CONTENTS ............. Summary of ALJs’ Analysis 134 140 . DECEPTIVE MARKETING AND ADVERTISING ....... . 140 ........ ETHICAL AND PROFESSIONAL RESPONSIBILITIES... A. Failure to Protect Patients 1. 2. 3. 4. 5. 6. 7. 8. 9. B. G and I through BB in Clinical Trials ................... G Patient ........................................................... Patients I and J ................................ Patient ...................................... ....... .. Patient ........................... ........ .. Patient P ......................................... Patient S .................................................................................................... Patient T .................................................................................................... Patient U ................................................................................................... N 0 . . Consent Forms .................................... Unethical Treatment of Patients Treating Patients D. 142 A Through F .. ................................................... 143 147 148 154 156 158 159 161 164 164 167 H-P Without Proper BRI—IRB Approval .............................. 168 Inadequate/Inaccurate Reports of Therapeutic Response ................................. 171 1. 2. 3. 4. 5. 6. V R Patient ................................................................................................... ........ Patient .. ............ .. .. Patient ................................................. Patient .......................... .. Patients Q, Z, AA, and BB ....... Patient .......... W Y X E. Inadequately Training Subordinates About Adverse Events ........................ F. Failing to Properly Consider G. Failing to Inform Patient G’s Treatment ............ and Report the Effect of Corticosteroids 172 172 173 173 174 178 179 in Patient ................................. 180 G of Additional Costs ................................................. 182 Inadequate and Inaccurate Patient CC’s Case History ..................................... 184 I. XI. Violations of Federal Regulations as Clinical Investigator ................................ 184 AGGRAVATING AND MITIGATING FACTORS A. ...... .. Aggravating Factors ............................................................ .......... 185 185 SOAH DOCKET NO. 503-14-1342.MD 1. 2. 3. PAGE 6 TABLE OF CONTENTS Severity of harm, harm to one or more patients, and one or more violations that involve more than one patient .................................... 185 Increased potential for harm to the public .................................. ......... 186 Prior similar violations and previous disciplinary action by the Board . .................. B. Mitigating Factors 1. 2. XII. X111. . ................................................................................................. Rehabilitative Potential Prior Service and Present Value to Cancer Patients FINDINGS OF FACT .......... CONCLUSIONS OF LAW .. .. Community of Terminally Ill . .. ........ ........................................... . ............................................... APPENDIX A - LIST OF MEDICINES 187 187 ...................... ............ 186 ................................................................................. 188 193 211 213 SOAH DOCKET NO. 503-14—1342.MD TEXAS MEDICAL BOARD, Petitioner V. STANISLAW R. BURZYNSKI, M.D., Respondent BEFORE THE STATE OFFICE § § § § § § § OF ADMINISTRATIVE HEARINGS PROPOSAL FOR DECISION The staff (Staff) of the Texas Medical Board (Board) seeks to impose disciplinary action against Stanislaw R. Burzynski, MD. (Dr. Burzynski/Respondent) for alleged violations of the Medical Practice Act1 and the Board’s rules2 in his treatment of cancer patients. This is a complex case involving a period of 13 years and Dr. Burzynski’s treatment of 30 patients within later reduced its that period. exhibits to 59 exhibits included, among Staff initially offered 68 volumes of documents volumes of exhibits that were admitted into evidence. Staff’ s other things, the medical records for Patients depositions, and portions of the medical records for Patients into evidence, but A through G, 36 H through DD. Staff submitted over who had either unsuccessfully 19,870 pages of documentary exhibits. The patients in issue were terminally—ill cancer patients tried conventional cancer treatment or had elected not to do so because of severe side effects with minimal prospect of curing the disease. Several of the patients were not expected to live for more than a year. In the 1990s, Dr. Burzynski discovered and patented an anti-cancer drug for Food and Drug Administration (FDA) approved several clinical studies to determine effectiveness in treating adults and children with advanced stages of cancer. patients elected to participate in the 1 2 Tex. Occ. Code (Code), The applicable Board this title 3, which the FDA-approved clinical studies, Many its of these and others chose to chapters 151—169. rules are located at 22 Texas Administrative Code (TAC) chapters 165, 179, and 190. In proposal for decision, the Board rules are referred to as “Board Rule xx,” or “22 TAC § xx,” using the specific number of the rule. SOAH DOCKET NO. 503-14-1342.MD PAGE 2 PROPOSAL FOR DECISION participate in “personalized medicine” treatment that targeted the cause of the cancer rather than the location of the cancer. Because of Dr. Burzynski’s treatments, several terminally ill patients recovered. Staff makes allegations against Respondent ranging from standard of care violations ethical violations in conducting clinical studies that are regulated by the FDA. to Staff relied heavily on the testimony of three experts, one on ethics, one on billing issues, and another regarding the standard of care. The experts’ qualifications will be discussed more fully it is important to know that Staff’s experts upon which they were asked to give pediatric oncologist, testified that ANP, when Patient D was had not seen all later, but the relevant records of the patients For example, Cynthia Wetmore, M.D., a an opinion. Respondent had misrepresented Patient D’s tumor response not treated at the Clinic. Staff’s reliance to on the testimony of these experts cast doubt on the validity of its allegations. The Board recognizes a that physicians may during the period patient’s right to seek alternative or non-standard therapy and provide such therapy. The alternative therapy provided by Dr. Burzynski at issue has since become more accepted and mainstream. During the hearing, Staff took the position that the applicable standard of care regarding Dr. Burznyski’s treatments was what was since in effect at the time become accepted in the he provided the treatment, even if that treatment protocol has medical community. Such an approach as taken by Staff would appear to discourage innovation in the treatment of advanced cancers. In this context, based on the evidence, the Administrative Law Judges (ALJs) find that Staff proved some, but not most, of its allegations against Dr. Burzynski. that there are mitigating and aggravating factors that the Board may The ALJs further find consider in issuing a final decision.3 3 Pursuant to Code § 164.007(a—1), the ALJs make findings of fact and recommendation regarding the appropriate sanction, if any, to impose. conclusions of law, but do not make any SOAH DOCKET NO. 503-14-1342.MD I. PAGE 3 PROPOSAL FOR DECISION JURISDICTION, NOTICE, AND PROCEDURAL HISTORY The parties did not contest notice or jurisdiction except as discussed below. On December 11, 2013, Staff filed an 8-page Complaint with the State Office of Administrative Hearings (SOAH). On July 10, 2014, Staff submitted a 202-page First Complaint substantially increasing the charges alleged against Respondent. Respondent filed an answer asserting two affirmative defenses: (2) lack approved by the Food and Drug Administration (FDA) where there On November 14, Complaint (the Complaint) that contains In response, (l) collateral estoppel4 of statutory authority to pursue claims regarding alleged Violations of a violation of federal law. is and clinical trial no federal finding of a 2014, Staff filed a 48-page Second Staff’s notice Amended Amended of the current allegations against Respondent. On August 21, 2014, Respondent filed a motion for summary disposition requesting that Staffs claims relating to alleged violations of federal regulations be dismissed. Staff argued, among other things, that Texas Occupations In response, Code (Code) §§ 164.052(a)(5) and 164.053(a)(l) authorizes the Board to sanction a licensee for any violation of state or federal law. The ALJs issued Order No. 7 on September Texas Administrative Code (TAC) 10, 2014, granting the motion in part. Pursuant to 22 § 190.8(2)(R), only alleged violations that are criminal in nature are subject to disciplinary action of the FDA-regulations by the Board under this section.5 Staff did not assert any criminal violations, therefore any allegations related to 22 § 190.8(2)(R) were disposed in Respondent’s TAC favor. The hearing on the merits convened on November 19 through 20 and 23 through 2015, January 19 and 4 Respondent referenced Order No. 12 issued April Board v. 5 May 3 through 6, and 9 through Burzynski. Order No. 7 (Sept. 9, 2014). 4, 12, 2016, before 2012, in SOAH 25, ALJs Catherine Egan and Docket No. 503-11-1669, Texas Medical SOAH DOCKET NO. 503-14-1342.MD Roy G. Scudday in the Attorneys Lee Bukstein, Staff.7 Attorneys William PAGE 4 PROPOSAL FOR DECISION P. Clements Building, 300 West 15th St., Austin, Texas.6 Amy Swanholm, Barbara Jordan, and Christopher Palazola represented Dan Cogdell, J. Dennis Hester, J. Gregory Myers, and Melanie Rubinsky represented Respondent. The record closed on August 15, 2016, with the filing of the parties’ closing arguments and highlighted exhibits.8 II. A. BACKGROUND, ALLEGAT IONS, AND APPLICABLE LAW Background Dr. Burzynski 1. Before immigrating to the United States in 1970, Respondent graduated from medical school in Poland in 1967 and received a Ph.D. in biochemistry in 1968. Between 1970 and 1977, Dr. Burzynski worked at Baylor College of Medicine doing cancer research. While there, he received funding from the National Cancer Institute to research the link between peptides in blood and cancer growth.9 According to Dr. Burzynski, he has authored over 300 publications dealing with cancer and cancer research; however, publications.10 He Sciences, and the is a member of the many were not published in peer-reviewed American Medical Society, American Academy of Medical Ethics, New York Academy of among other organizations. 6 During the proceeding, Dr. Burzynski’s cardiac health issues required a delay in reconvening the hearing from May 2016. On May 3, 2016, ALJ Egan had to leave the hearing due to a family emergency. The parties elected to proceed with the hearing with the understanding that ALJ Egan would read the transcript for that portion of the hearing that she was unable to attend. ALJ Egan affirms she has read the May 3, 2016 transcript. January 19 to 7 Mr. Bukstein retired from the Texas Medical Board (Board) and did not appear in this proceeding after January 19, 2016. Ms. Swanholm took over as Staff’s lead counsel. 8 Order No. 36 (Aug. 2,2016). 9 Tr. Vol. 7 at 30. 1° Tr. Vol.7 at 31, 36-37. ‘ PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD PAGE 5 The Clinic 2. In 1977, Dr. Burzynski opened the Burzynski Clinic (Clinic), a private medical practice in Houston, Texas, to treat cancer patients.11 Dr. Burzynski testified that approximately Many the Clinic’s cancer patients have a terminal diagnosis. 2 conventional cancer treatment without success.1 95% of Clinic patients had tried Beginning in 1990, Dr. Burzynski began adding gene-oriented treatment with personalized treatment to the Clinic’s cancer patients. He explained that instead of treating the type of the cancer, he treats the cause of the cancer—the abnormal genes.13 In his opinion, the “clue targeted agents,” sometimes using four or to success is a combination of a number of gene— five gene-targeted agents.14 During the relevant periods from 2000 to 2013, the Clinic employed approximately 150 This included three board-certified oncologists, Drs. Jai Joshi, Jose Valladares and people.15 Zanhua Yi; two practitioner, Dr. internists, Drs. Robert Weaver and Gregory Burzynski; and one family Alejandro Marquis.16 All six were licensed to practice medicine in Texas during the time pertinent to this case. The Clinic also hired unlicensed foreign-trained doctors to assist the physicians as research associates. The Clinic assigned each patient to a team of health care providers that included an oncologist, an internist or family practitioner, and a research associate, all of Whom met with the patient and Respondent options. 11 ‘2 ‘3 1“ ‘5 ‘6 ‘7 ‘7 Tr. Vol.7 at 33. Tr. Vol.7 at Tr. Vol.7 at 34. Tr. Vol.7 at 34-35.. Tr. Vol.7 at 72. Tr. Vol.7 at 36-37. 72-74. Tr. Vol. 7 at 81-82, at the initial consultation to discuss treatment PAGE 6 PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14—1342.MD Burzynski Research Institute/Institutional Review Board (BRI/IRB) 3. Dr. Burzynski testified that, based blood with anticancer activities.18 investigational drug, antineoplaston on his prior research, he discovered chemicals in the In 1993, the FDA approved a clinical trial for the (ANP), in the treatment of cancer patients.19 Over the years, Dr. Burzynski estimated, he engaged in 65 prospective clinical trials and one retrospective Dr. Burzynski testified that BRI, of which he clinical trial.20 80% ANP of the shares, was created in 1983 to sponsor Dr. Burzynski, BRI is not engaged Dr. Burzynski testified that IRB was BRI. in the practice IRB was is the president and the clinical trials. owner of According to of medicine.21 also created in 1983, but it is a separate entity from created to supervise the ethical conduct of clinical studies by approving or on the and the response of the disapproving clinical trial investigational agent; and to evaluate data on the efficacy of the investigational agent ANP.22 IRB is Clinic’s protocols; to collect data not in the business of practicing medicine.23 employees is a member of IRB. toxicity Neither Dr. Burzynski nor any of the The IRB consists of 14 members. Carlton Hazelwood, M.D., a retired professor of pediatrics and physiology at the Baylor College of Medicine, is IRB’s chairman.24 Dr. Burzynski testified board members.25 18 Tr. Vol.7 at 33. 19 Tr. Vol. 7 at 63. 2° Tr. Vol. 7 at 45. 21 Tr. Vol. 7 at 51-52. 22 Tr. Vol. 7 at4l-42. 23 2“ 25 Tr. Vol.7 at 64. Tr. Vol. 7 at41-43. Tr. Vol.7 at 43. that he had no role in the selecting the SOAH DOCKET NO. 503—14-1342.MD B. PAGE 7 PROPOSAL FOR DECISION Staff’s Allegations cover a period from 2000 through 2013. The issues in Staff‘s allegations on Respondent’s cancer treatments, the marketing of his treatments, and Clinic’s personnel and the clinical trials.26 Staff’s allegations against his this case center management of the Respondent can be divided into the following general categories: (1) Failing to treat Patients (2) Engaging A through G according to the generally accepted standard of care; in unprofessional 0 properly supervise unlicensed and unqualified medical personnel; improperly delegating professional medical responsibility to unlicensed personnel; and misleading patients about the Clinic’s personnel; failing to failing to provide review and sign; adequate written informed consents for patients to ownership pharmacies and a laboratory; 0 failing to disclose his 0 overcharging patients; and 0 deceptively marketing and advertising the Clinic’s cancer treatments; and interest in Violating ethical and professional responsibilities by: 0 failing to protect patients in clinical trials, specifically Patients through BB; G and I A through F; 0 engaging in unethical treatment of Patients 0 treating Patients 0 reporting inadequate or inaccurate therapeutic responses for Patients and 26 likely to deceive the public by: 0 (3) and dishonorable conduct that was H through P without proper BRI—IRB approval; Q through BB; The ALJs will address the treatment dates that are in issue for each patient raised by the parties arguments. Order No. 34 (June 6, 2016). G in their closing SOAH DOCKET NO. 503-14-1342.MD 0 failing to train subordinates adequately Q through U; and 0 G and report Patient G’s reactions to corticosteroids and inform her of additional costs imposed by the Clinic; 0 providing inadequate or inaccurate case history for Patient CC; and o violating federal regulations as the clinical investigator. Applicable Law The Board may take Board about adverse events for Patients failing to evaluate failing to C. PAGE 8 PROPOSAL FOR DECISION rule or the Code disciplinary action against a licensed physician who has violated a or failed to practice medicine in an acceptable professional manner consistent with public health and welfare.27 Disciplinary actions include revocation, suspension (including a probated suspension), or reprimand.28 Staff’s allegations are based on the following provisions of the Act and the Board’s rules: Statutory 1. Code § Grounds for Disciplinary Action 164.052 states that a physician commits a prohibited practice, subjecting the physician to disciplinary action under Code “unprofessional or dishonorable conduct that the public; ”29 is § 164.051, if the physician engages in likely to deceive or defraud the public or injure uses false, misleading, or deceptive advertising;30 or directly or indirectly aids or abets an unlicensed person in the practice medicine.31 Code § 164.053 defines unprofessional or dishonorable conduct likely to deceive or defraud the public to include conduct in which the physician: ( 1) commits an act that violates any state or federal with the physician's practice of medicine; 27 Code 28 Code §§ 29 Code§ 164.052(a)(5). 3" Code§ 164.052(a)(6). 31 Code§ 164.052(a)(17). § 164.051(a)(3),(6). l64.001(a), .051(a). law if the act is connected SOAH DOCKET NO. 503—14-1342.MD PAGE 9 PROPOSAL FOR DECISION (5) prescribes or administers a drug or treatment that is nontherapeutic in nature or nontherapeutic in the manner the drug or treatment is administered or prescribed; (6) prescribes, administers, or dispenses in a manner health and welfare: inconsistent with public (A) dangerous drugs as defined by Chapter 483, Health and Safety Code; or (B) controlled substances scheduled in Chapter 481, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.); and Safety Code;32 (7) violates Section 311.0025, Health (8) fails to (9) delegates professional medical responsibility or acts to a person if the delegating physician knows or has reason to know that the person is not qualified by training, experience, or licensure to perform the responsibility or acts. supervise adequately the activities of those acting under the supervision of the physician; or According to Code § may 157.001, a physician trained person any medical act so long as the person is and does not represent to the public that the person delegating physician medical is delegate to a qualified and properly acting under the physician’s supervision is authorized to practice medicine. The responsible for “the medical acts of the person performing the delegated acts.”33 Board Rules 2. Board Rule 165.1 requires licensed physicians to maintain adequate medical records for each patient that are “complete, contemporaneous, and legible.”34 The patient’s medical record must document, among other 32 Texas Health (1) the reason for each visit, the patient’s & Safety Code § 311.0025(a) states that a health care professional may not submit to a patient a bill for treatment that the professional clinically unnecessary. 33 Code§157.001(b). 34 22 TAC§ things, the following: 165.1. knows was not provided or knows was improper, unreasonable, or medically or SOAH DOCKET NO. 503-14-1342.MD PAGE 10 PROPOSAL FOR DECISION relevant history, the physical examination findings, and prior diagnostic test results; (2) the physician’s assessment, clinical impression, or diagnosis; (3) the plan of care; and (4) the date and “legible identity of the observer.”35 In addition, medical records should include, among other things, past and present diagnoses; the physician’s rationale for and the results of diagnostic and other ancillary services; the patient’s progress and response to treatment; and the relevant risk factors.36 As noted above, physicians are subject to sanctions for failing to practice medicine in an 7 acceptable professional manner consistent with public health and welfare.3 22 TAC § 190.8(1), this includes, but is not limited According to to: failure to treat a patient according to the generally-accepted standard o negligence in performing medical services;39 0 failure to use proper diligence in one’s professional practice;40 0 failure to safeguard against potential complications;41 0 failure to disclose reasonably foreseeable side effects of care;38 of a procedure or treatment;42 0 0 failure to disclose reasonable alternative treatments to a proposed procedure or treatment;43 and failure to obtain by law 35 36 TAC § 22 TAC§ 22 37 Code 3* TAC § 22 TAC § 22 TAC § 22 TAC § 22 TAC § 22 TAC§ 39 4° 4‘ 42 43 22 informed consent from the patient or other person authorized on the patient’s behalf before performing tests, to consent to treatment 165.1(a)(1)(A)-(D). l65.1(a)(2)—(5). § 164.051(a)(6). 190.8(1)(A). 190.8(1)(B). 190.8(1)(C). 190.8(1)(D). 190.8(1)(G). 190.8(1)(H). _ SOAH DOCKET N O. 503-14—1342.MD treatments, procedures, or autopsies as required under Chapter of Criminal Procedure; PAGE PROPOSAL FOR DECISION 44 Unprofessional and dishonorable conduct that is likely 11 49 of the Code to deceive, defraud, or injure the public includes: 0 referring a patient to a facility, laboratory, or pharmacy without disclosing the 4 existence of the licensee’s ownership interest in the entity to the patient; and 0 providing medically unnecessary services to a patient or submitting a billing statement to a patient or a third party payer that the licensee knew or should have known was improper. (“Improper” means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.)46 3. Board Rules Regarding Clinical Investigations Physicians engaged in the clinical investigation of comply with the ethical and professional responsibilities new set drugs and procedures must out in Board Rule 200.3(7). Specifically, physicians are expected to conform to the following ethical standards: (A) Clinical investigations, medical research, or clinical studies shall be part of (B) A clinical investigator shall demonstrate the same concern and caution for a systematic program competently designed, under accepted standards of scientific research, to produce data that are scientifically valid and significant; the welfare, safety and comfort of the patient involved as is required of a physician who is furnishing medical care to a patient independent of any clinical investigation; (C) 44 45 46 A clinical investigator shall have patients sign informed consent forms that are compliant with federal regulations, if applicable, and that indicate that the patients understand that they are participating in a clinical trial or investigational research. TAC § 190.8(1)(I). 22 TAC § 190,8(2)(H). 22 TAC§ 190.8(2)(J). 22 and 4. PAGE 12 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Aggravating and Mitigating Factors The Board’s rules set out certain specified aggravating and mitigating factors relevant determining whether more or less severe or restrictive action by the Board is has the burden to present evidence regarding any aggravating factors that particular case, factors that and the physician has the burden Staff’s to present evidence regarding apply in a any mitigating OVERVIEW OF THE EVIDENCE Evidence Staff initially offered 68 to may Staff may apply.47 III. A. warranted. to volumes of exhibits into evidence, but later reduced its exhibits 59 volumes of documents that were admitted into evidence. Staff‘s exhibits included, among other things, the medical records for Patients medical records for Patients Norman 0 H through DD. Fost, M.D., expert witness; B. MPH, A through G, 29 depositions, and portions of the Staff also called the following witnesses: a licensed pediatrician and bioethicist called as an NE-BC, MBA, a health care professional called as an expert 0 Elaine Kloos, R.N., witness; 0 Cynthia Jean Wetmore, M.D., Staff‘s oncology expert; 0 Patient F; 0 Patient F’s wife; and 0 Patient A’s wife. Respondent’s Evidence Respondent introduced 28 exhibits that were admitted into evidence. Respondent also called the following witnesses: 47 22 TAC§ 190.15. PAGE 13 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Tomasz J anicki, M.D., Director of Medical Documentation of the Clinic and Vice President of Clinical Trials, called as an expert witness; Mark Levin, M.D., Respondent’s oncology expert; Dr. Burzynski, who testified as both a fact witness and an expert witness; Gregory Burzynski, M.D., Dr. Burzynski’s son and the Clinic’s internist; Mary Michaels, the mother of a pediatric patient; Mary J o Siegel; a patient; Mary Susan McGee; the mother of a pediatric patient; Lourdes DeLeon; a research associate Alejandro F. Marquis, at the Clinic; MD. a family practitioner at the Clinic; Margaret Manning, a patient; and Robin Ressel, the mother of a pediatric patient. The Experts Staff called three expert witnesses to testify. Staff called Dr. Fost as an expert in physicians’ ethical and professional responsibilities during a clinical investigation.48 Ms. Kloos was designated as Staff’s expert in medical billing practices.49 Dr. Staff’s expert in the standard of care in the treatment of primarily adult cancer Respondent called two expert witnesses approved clinical trials for to testify: Dr. Janicki, designated as ANP;51 and Dr. Levin, designated as an expert of treatment of cancer patients in a private Dr. Fost’s prefiled testimony Wetmore was designated was admitted Dr. Janicki’s prefiled testimony Dr. Levin’s prefiled testimony into evidence as Staff Ex. 68.02. was admitted into evidence as Staff Ex. was admitted into evidence was admitted into evidence patients.50 an expert in FDA— in the standard of care Respondent also provided expert testimony into evidence as Staff Ex. 68.01. Ms. Kloos’s prefiled testimony was admitted Dr. Wetmore’s prefiled testimony setting.52 as 6803. as Resp. BX. 158. as Resp. BX. 165. SOAH DOCKET N O. 503-14—1342.MD PAGE 14 PROPOSAL FOR DECISION regarding the standard of care; however, his testimony will be considered when addressing Staff’s specific allegations. 1. Staff’s Experts a. Dr. Fost Dr. Post residency in 1967, was an He completed his a Wisconsin board—certified pediatrician and a bioethicist.53 is was chief resident assistant professor in the at Johns Hopkins Hospital from 1969 through 1971, and Department of Pediatrics at Johns Hopkins Hospital from 1971 through 1973. Dr. Fost has been associated with the University of Wisconsin since 1973 in a number of positions including Program assistant professor in the in Bioethics, Professor Department of Pediatrics, Director of the of Pediatrics and Medical History & Bioethics, Chair of the Bioethics Advisory Committee, and Vice Chair of the Department of Medical History Bioethics.54 Dr. Fost of Human is a member of the American Academy of Pediatrics, the & American Society Genetics, and the American Society of Bioethics and Humanities,55 While at the University of Wisconsin, Dr. Fost practiced pediatric clinical medicine until June 2014.56 Dr. Fost does not have specialty training in the treatment of patients with cancer.57 served as a member of has never been a principal investigator in a cancer clinical 3 61.34 StaffEx. at 45152; StaffEx. 68.01 5“ StaffEx. 61.B.4. 55 StaffEx. 61.B.4 at 45159. 5" StaffEx. 68.01 at3. 57 Tr. V01. 0. 8 59 1 at 97. StaffEx. 68.01 at 4-5, Tr. V01. 1 at 112-113. has several institutional research boards, including as the chair of the University of Wisconsin Health Science Center’s Institutional u- He at 1. Review Board trial.59 for 31 years.58 He SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION Ms. Kloos b. Ms. Kloos is a registered nurse and a' certified Nurse Executive. twenty years in oncology administration and women’s health services Center in Shreveport, Louisiana; Monmouth Medical Hunterdon Medical Center in Flemington, New in Pipersville, Pennsylvania.60 Jersey; She has been responsible Executives.61 since 1991, and manual is for financial a member of Dr. Wetmore is transplant.63 in Management Consulting the Association of Cancer (CPT) codes and the CPT board-certified in pediatrics and in pediatric hematology/oncology/bone She completed her residency Since 2014, Dr. where she cares Wetmore Jersey; Wetmore in 1997, Wetmore has been and was a professor» a is for at the Mayo at the Clinic Mayo from 2002— the Director of the Center for Clinical and Translational Research for the Department of Pediatrics at Dr. New coding and billing for oncology centers Medical School and a consultant in the Department of Pediatrics 2010.64 Shumpert Medical Roper Saint Frances Healthcare familiar with Current Procedural Terminology c. marrow is at used for billing of medical services.62 that are Dr. Ms. Kloos She has worked over Center in Long Branch, Charleston, South Carolina; and for the last nine years at the Oncology Group 15 Emory University School of Medicine oncology patients in the outpatient as well as inpatient member of the Medical Advisory Board for the setting.65 Make-A-Wish Foundation, the Development Therapeutics Committee of the Children’s Oncology Group, and the Lifespan Domain Task Force of the National Center 6° StaffEx. 61.C.5 at 4522245223. 6‘ StaffEx. 61.05 at 45223. 62 StaffEx. 68.02 at2. 63 StaffEx. 68.03 at4. 6“ StaffEx. 61.A.3 65 StaffEx. 68.03 6“ StaffEx. 61.A.3 at 45106. at 3. at 45107. for Advancing Translational Science.66 SOAH DOCKET NO. 503-14-1342.MD Dr. Wetmore is a pediatric oncologist and has not been the primary treating physician for adults with colon cancer, 67 mesothelioma,68 kidney cancer, 69 or pancreatic cancer.70 She stated that in preparation for her involvement in this case she relied on the National Comprehensive Cancer Network (N CCN) guidelines that pertained to the cancers Patients adult patients had to that were admitted PAGE 16 PROPOSAL FOR DECISION form her opinions. However, the into evidence A through G and other NCCN guidelines Dr. Wetmore relied on were not published during the time these patients were being treated.71 The ALJs note that Dr. Wetmore also testified that Patient D “did not receive the standard of care and was exposed to medications that are not documented to cross the blood brain barrier . 3’72 She stated failing to that Respondent had violated the standard of care in treating Patient D . by allow a “wash-out” period after discontinuing one drug before beginning another.73 Contrary to Dr. Wetmore’s testimony and report, Patient D received no treatment or therapy at the Clinic.74 Respondent’s Experts 2. Dr. Levin a. Dr. Levin is board-certified in internal medicine, oncology, and hematology. He completed his residency in 1987, and has practiced medical oncology and hematology in a variety of settings, including several academic institutions, for over 25 years.75 67 Tr. Vol.3 at 28. 68 Tr. v61. 3 at 27-28. 69 Tr. v61. 3 at 20. 7° Tr. v61. 3 at28. 7‘ Tr. Vol.3 at 99; StaffEx. 63, 72 StaffEx. 68.03 at 49. 73 StaffEx. 68.03 at 48; Tr. v61. 3 at 22. 7“ Tr. v61. 3 at 22. 75 Resp. Ex. 165 atil. He has served as SOAH DOCKET NO. 503-14-1342.MD the Chief of Hematology and Oncology at the Lincoln Medical Center; Director of the Hereditary Cancer Clinic and Director of Clinical Research at Holy of Hematology and Oncology Sister Patricia at the is at Holy New Jersey; Name Hospital; and the Director York City.76 currently in private practice in Cliffside Park, New J ersey.77 He is President of Medical Review and Information Center, a consulting company, and Knowledge is Chief Trustee of Power, a non-profit that supports a cancer information website and cancer is education outreach.78 utilization Director of the Generations and Northern Manhattan Network of the Health and at the Hospitals Corporation of New Dr. Levin Name Hospital; Acting Chief University Hospital in Newark, Lynch Regional Medical Cancer Center of the Cancer Center PAGE 17 PROPOSAL FOR DECISION He consults with insurance companies and hospitals, is certified in review and quality assurance, and has conducted reviews of hundreds of oncology practices, similar to what he is doing in this case.79 Dr. Levin recognized Dr. Wetmore’s expertise in pediatric oncology, but questioned her expertise in medical oncology (treating adult patients). oncology and pediatric oncology are two different medical According to Dr. Levin, medical specialties. He explained that adult cancers, such as renal cancer, colon cancer, pancreatic cancer, mesothelioma, and glioblastoma are rare that among children. Similarly, most pediatric cancers are rare among adults. He stressed even cancers that both children and adults experience, such as brain cancer, have different histologies and different standards and clinical approaches to treatment. Other differences exist between the two specialties. academic practice setting (universities or research hospitals), but Typically, Dr. Levin noted, pediatric oncologists in a private practice setting. In addition, Children’s Oncology Group’s clinical patients are enrolled in clinical trials.80 76 Resp. Ex. 118 at 4. 77 Resp. BX. 118 at 6. Resp. BX. 118 at 6. Resp. Ex. 165 at 3-4. Resp. Ex. 165 at 9. or other trials, in an most medical oncologists work most children with cancer, he explained, trials work but less than 2 to are enrolled in 5% of adult cancer PAGE 18 PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14—1342.MD Dr. Janicki b. Dr. Janicki was licensed medicine in Poland in 1992 and practiced in the and cardio-surgery department of the Hospital of Wroclaw from 1993— pediatric cardiology 1996.81 Dr. Janicki to practice not licensed to practice medicine in the United States. Beginning in 1997 is he became Director of Medical Documentation for the Clinic, and in 2012 he was appointed Vice president of Clinical Trials at the trials for BRL82 He has been involved with the F DA-approved clinical ANP since the late 1990’s.83 IV. The ALJs STANDARD OF CARE will discuss the issues using the outline set forth in the ALJ’s Order No. 34, where possible, with the specific subjects addressed under the allegation most The ALJs add a brief summary of the patient’s relevant medical history where appropriate. will However, before discussing the specific to the testimony Dr. clearly applicable. allegations, the ALJs will address the weight to be given of the oncology experts. Wetmore’s testimony regarding Patient D is troubling. According to Dr. Wetmore, she reviewed the Clinic’s medical records carefully before preparing her expert report and her prefiled testimony. Yet, she accused Respondent of violating the standard of care in his treatment of Patient D, to the accuracy Dr. when Patient D received no treatment at the Clinic. of her report raises concerns about her Wetmore is Such inattentiveness credibility. an accomplished oncologist, but her primary focus has been in pediatric medicine, not in treating adult patients with cancer. Her oncology practice has been in academic settings as reflected on her CV, and there oncology in a private practice 8‘ Resp. BX. 120 at 1. *2 Resp. BX. 120 at 1. 83 Resp. Ex. 158 at 2. setting. is little evidence to show that she has practiced Therefore, the ALJs find that Dr. Wetmore’s expertise SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 19 about the treatment of adult cancer and the standard of care used by physicians in private practice limited and will be given is little weight. General Allegations Regarding Patients A. A through G A through G were adult patients with terminal (Stage III and IV) cancer treated during the period from 2009 through 2012. Patient A was diagnosed with Stage IV colon cancer. Patients Patients B, D, and mesothelioma. Patient were diagnosed with brain cancer. E had ANP C was diagnosed with clinical trial, Patient G was treated under an FDA-approved single patient protocol BT—09.84 Patients A, B, C, E, and F were treated with sodium phenylbutrate (PB) were not treated with ANP. ' Patient kidney (renal) cancer, and Patient F had Stage IV pancreatic Although none of these patients were enrolled in a cancer. with G Patient in combination with other B was treated with ANP in chemotherapy drugs, but Germany by his local oncologist.85 1. Potential Toxicities of Combined Drugs Staff argues that Respondent violated the standard of care and engaged in non-therapeutic prescribing by failing to “articulate a medical rationale for the initial treatment, the subsequent changes to this treatment, and for the decision parties agreed that “off-label” use to continue or discontinue the treatment.” of chemotherapy drugs and targeted agents accepted and can be within the standard of care. In fact, the is The medically NCCN estimated that, in 2005, “50 percent to 75 percent of all uses of cancer therapy were off-labe 1.”86 According to Dr. Wetmore, the standard of care in medicine is circumstances.”87 She stated that “what a reasonable physician would do in the same or similar when the cancer treatment involves the use of multiple anti- cancer agents, the physician must document an adequate rationale for the treatment plan, for any 8“ Staff Ex. 7.01 at 2449-2464. 85 Appendix A to this PFD sets forth a list of the brand and generic names of the drugs referred PFD, the ALJs will use the brand name where possible. this 86 Tr. Vol. 11 at 158-159. *7 StaffEx. 68.03 at 8. to in the PFD. For PAGE 20 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD changes in the treatment plan, and for discontinuing the treatment.88 This medical rationale, she mamtamed, must be based on peer—rev1ewed . . . When combining drugs for cytostatic (stop cells because there is selentific ev1dence of safety and efficacy. . . off-label purposes, including concurrent from dividing) and cytotoxic serious risk of . unknown (kill cells) side effects, it is medications, Dr. 89 combinations of Wetmore said that, essential that patients receiving such drugs or combination of drugs be adequately monitored for any potential side effects.90 In her opinion, Respondent failed to document his medical rationale for using multiple anti—cancer agents and failed to properly monitor the patients. In addition, Dr. when he changed Wetmore testified that Respondent failed to meet the standard of care the patient’s treatment without allowing time for the discontinued drug to “wash—out” of the patient’s body before beginning another toxic drug. Dr. Wetmore testified that Respondent prescribed Avastin, a drug bloodstream for more than a month, to Patients A, B, C, and care requires waiting six another drug. Dr. weeks for Avastin to clear the Wetmore explained that this F. which She stated body before “wash-out” period is As an example, stays in a patient’s that the standard starting treatment of with necessary to prevent harm and/or more toxicity to the patient from having both toxic medications in the body. Dr. Wetmore testified that Respondent discontinued the Avastin and started another drug without waiting for the Avastin to wash out of the patients’ systems, and consequently exposed these patients to increased toxicity and adverse events.91 Dr. Fost referred to Respondent’s treatment protocol as “innovative therapy” because the “drugs or combination of drugs” had not yet been studied for safety and efficacy. Consequently, Dr. Fost opined, Respondent exposed these patients to a substantial risk of harm.92 Staff accepts that innovative therapy is not necessarily substandard care. 8“ at) 9 StaffEx. 68.03 at 9, 18. StaffEx. 68.03 at30. 9° StaffEx. 68.03 at 18. 91 StaffEx. 68.03 at 18-19. 2 StaffEx. 68.01 at \D 22-23. However, Staff alleged that Respondent failed to PAGE 21 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD meet the basic standard of care requirements to show that the treatments were supported by rational, credible research and general consensus among physicians.93 Dr. Levin disagreed with Staff. He explained that Respondent provides personalized treatment for cancer patients based on genomic and chemo-sensitive tools that were analyzed to create a treatment plan unique to each patient. The pathways, not the name of the particular type of cancer the patient has, dictate the drugs to use. Dr. Levin acknowledged that treatment paradigm.94 Except for Patient G, Patients this is a new A through C and B through F were being by Respondent with “Personalized or Precision Medicine” (personalized therapy) treated terminally-ill cancer patients.95 When using this for approach, Dr. Levin clarified, the specific type of cancer (as well as the tumor’s histology or morphology) is less important than “what targets, pathways, proteins, and other specific alterations the patient’s tumor expresses.”96 In Dr. Levin’s opinion, personalized therapy a reasonable medical approach for the is treatment of advanced stages of cancer, and noted that this approach “has been around for the past half of a dozen years.”97 Dr. Levin also took issue with Dr. Wetmore’s claim that failing to have a wash-out period when Respondent changed a patient’s medication constituted a standard of care violation. He testified that the term “wash-out” Dr. Levin testified that a clinical setting. previous drug to “wash out” so assessment is not compromised by when doing that, if there is . . . is a research concept and research PB irrelevant in important to allow the a response to the experimental drug, the the effects of the prior drug.”98 Dr. Levin stated that the use of PB outside of clinical trials out that the Clinic had used “it is is for at least 10 years and that PB is rare. is However, he pointed closely related to ANP, the drug Respondent invented. Moreover, the Clinic’s patients typically had no curative treatment 93 Staff’s 94 Resp. Exs. 119 at 95 Resp. Ex. 165 at 96 Resp. Ex. 165 at 28. 97 Resp. Ex. 165 at 25. Resp. BX. 165 at 10-11. Closing Argument 1; 165 24-25. at 5. at 24. SOAH DOCKET NO. 503-14-1342.MD options left.99 At this point, Dr. Levin opined, come up with patient, to experience. When 9:100 rationale, the use patients is quite PAGE 22 PROPOSAL FOR DECISION it is “the physician’s duty, in consultation with the the best possible treatment based on, in part, the physician’s prior based on the physician’s prior experience, literature, and therapeutic of multiple targeted agents and other cancer drugs in advanced stage cancer common, according to Dr. Levin.101 Inadequate Medical Rationale for Treatment with ANP, PB, and/or the 2. Combined Use of Drugs Staff asserts that Respondent violated the standard of care because he did not provide an adequate medical rationale for the use of ANP, PB, or combinations of drugs. As testified by Dr. Wetmore, the basic requirements of adequate medical rationale must include an adequate treatment plan clearly stating drug name, dose, and route of administration and monitoring. stated that a physician must document an adequate medical rationale for nonstandard She and unevaluated doses and combinations of cytostatic and cytotoxic medications. In her review of the patients’ medical records, Dr. Wetmore concluded that for Patients Respondent did not provide an adequate treatment plan documented A, B, C, D, E, and in the F, medical records by planned dosage for medications, addressing the reason for changes in dosages Without listing the any rationale or consideration of adverse side effects, making unreliable and inaccurate determinations of treatment response, and initiating and/or discontinuing the medications administered without giving a reason.102 Dr. Wetmore testified that the plasma tests Respondent required were not medically necessary because the tests needed to be performed on tumor tissue as opposed to blood.103 However, she agreed 99 Resp. Ex. 165 that the use at 32. 10° Resp. Ex. 165 at 32. “’1 Resp. Ex. 165 at 34. “’2 StaffExs. 61.01(A); 68.03 at 47. '03 Tr. v61. 4 at 29. of blood biopsies for analysis of proteins as well as DNA is an emerging trend, but only testified that, while this type of testing it is to on an exploratory not common to use blood tests to detect targets, it is it Dr. Levin reasonable to use is particularly can take weeks to get the results of tumor 105 FDA clinical trials as follows: Phase (1) assess toxicity and try to determine the highest tolerated dose; (2) Phase seek to tests, determine what drugs to utilize in patient treatment. This Dr. Burzynski explained the phases of trials blood basis.104 In regard to requiring reasonable for terminally-ill patients because testing. PAGE 23 PROPOSAL FOR DECISION SOAH DOCKET N O. 503—14-1342.MD I clinical II clinical trials find out the treatment effectiveness based on the shrinkage of the tumor; and (3) Phase III clinical trials compare the effectiveness of the investigational medication and treatment with the best available conventional treatment based on survival He rates.106 stated that ANP, which he discovered, affects approximately 100 genes that can cause cancer, which effectively treat some is enough to cancer, but not others.107 Dr. Burzynski testified that blood tests support the medical rationale for treatment because it identifies the proteins produced by genes, fragments of abnormal genes that are causing cancer. because it does not require surgery to obtain expensive, and provides tissue. known He stated that this form In his opinion, this more information about cancer in the According to Dr. Burzynski, PB affects the as genetic markers, and J. inhibits cancer cell division or multiplication.110 ‘04 Tr. V01. 14 at 81, 100. ‘05 Resp. BX. 165 ‘06 Tr. VOl. 7 at 66-68. ‘07 “’8 ‘09 “0 at 46. Tr. Vol.7 at 72. Tr. Vol.7 at 89-92. Tr. Vol. 7 at 98-99. Tr. V01. 7 at 104-105. is less is easier invasive, less entire body.108 HDAC, which turns Citing to a study of PB in the group of enzymes called off the activity of tumor suppressor genes and promotes cancer.109 treatment of advanced cancer conducted by Dr. of testing finds Gilbert, et.al., Dr. He Burzynski testified that pointed out that the FDA PB has recognized PB may that possibility that types of aggressive leukemia. ‘As noted above, Dr. be effective for treatment of malignant brain tumors and certain 1 11 Levin testified that been tested together and are not part of an then it if trials NCCN even though the drugs used have not treatment recommendation. a physician prescribed a targeting agent was obvious He was of the accepted in medical oncology to provide it is personalized or precision medicine outside of clinical explained that PAGE 24 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14-1342.MD known Dr. Levin to affect a particular to him, as a private practice oncologist, the reason pathway, why the drug was utilized. opinion that the standard of care does not require the physician to document that he prescribed drug readily understood X because by medical it affects a certain pathway, and that the medical rationale is oncologists.112 Inadequate Medical Rationale for the Evaluation, Diagnosis, and Treatment 3. of the Patients As noted above, Dr. Wetmore testified that the basic requirements of an adequate medical rationale include the following: (1) the treatment must be predicated on adequate histological diagnosis and pathologic confirmation of the cancer; (2) there must be an adequate and complete physical examination including mental status examination at each visit and prior to administering therapy, and (3) there must be an adequate treatment baseline for a patient’s mental function She testified that is critical plan.113 when She maintained that establishing a evaluating treatment for brain cancer.114 an adequate mental status exam requires a general orientation to person, place, and time; an understanding of the diagnosis and purpose verification of the patient’s ability to make for which the patient is being seen; decisions for themselves; the ability of the patient to take medication as prescribed; the awareness of the risks and side effects of medication; and the patient’s frame of mind “1 ‘2 ._. Tr. Vol.7 at 99. Tr. Vol. 11 at 162-163. 3 StaffEx. 68.03 l 4 StaffEx. 68.03 at 44. l 5 StaffEx. 68.03 at 11. l ._. at 10-11. and general psychiatric condition.115 SOAH DOCKET NO. 503—14-1342.MD Dr. Levin disagreed with Dr. Wetmore’s opinion. or usual to perform a formal mental indication that the patient is PAGE 25 PROPOSAL FOR DECISION exam on a cancer He testified that it was not necessary patient unless the physician has some not properly oriented. In his opinion, the interaction of the physician with the patient and family members is normally sufficient to determine whether the patient is adequately oriented to understand and consent to treatment.116 4. Inadequate Medical Documentation Ms. Kloos reviewed the medical records for Patients A through available to her in order to determine whether they could support the testified that she found CPT the patient. by the provider that Staff billing codes. numerous medical recordkeeping deficiencies. She noted the medical records did not contain signatures, dates, or times of service was seeing G “7 Ms. Kloos testified that to ensure the services rendered reviewed, and authenticated. 1 that that many of medical billing records must be authenticated were accurately and appropriately documented, 18 inconsistent, and time of service and She from the provider who In her expert report, Dr. Wetrnore opined that the medical records for Patients G were inadequate, made it For medications administered, and missing portions. She stated that many pages had no date was it A through often impossible to tell who provided the care to a patient. was unclear to her what dosage a patient received, the frequency of administration, and the concentration (for infusions). Handwritten orders were often unclear, improper, and used non-standard language when prescribing the chemotherapy drugs. She found numerous pages missing from the records she reviewed, such as progress notes. There was no underlying imaging for most of the diagnostic scans ordered by the Clinic, as well as imaging ordered prior to the patients’ appearing “6 “7 “8 Resp. BX. 165 at41. StaffEx. 68.02 at 11. StaffEx. 68.02 at 103. at the Clinic. Imaging reports created by the Clinic showed results inconsistent difference. 1 PAGE 26 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD with outside radiology reports, with no explanation for the 19 Following his review of the medical records, Dr. Levin reported that the medical records of the Clinic were well organized, presented a clear picture, and contained laboratory, imaging, and pathology reports. He stated that he had no difficulty all relevant in understanding the development of the treatment plan over time, the basis for the treatment decisions, and the results for the treatment from the medical records of the Clinic.120 ALJs’ Analysis 5. :1. Potential Toxicities of Combined Staff argued that, based Drugs on the testimony of Dr. Wetmore, Respondent violated the standard of care and engaged in non-therapeutic prescribing by failing to “articulate a medical rationale” for the initial treatment, subsequent treatment changes, and the decision to continue or discontinue the treatment. that it was When combining essential that patients receiving such drugs or monitored for any potential side The drugs for off-label purposes, Dr. Wetmore stated combination of drugs be adequately effects. parties agree that “off-label” use of chemotherapy drugs and targeted agents is medically accepted and can be within the standard of care. Respondent argues that his medical rationale was based on the clinical patients with the potential risks all judgment of the and side as reflected in the medical records. treating physicians, effects discussed, was explained to the and that the patients were monitored, Additionally, Respondent asserts that the side effects were sufficiently documented in the written informed consent forms signed by the patients. Dr. Wetmore stated that Respondent failed to meet the standard of care when each toxic drug used in the treatment of a patient was started without allowing time for the discontinued “9 12° Staff Ex. 61.01(A) at 45075, 45079, 45080-45081, 45085, 45087-45088, 45090-45091, 45092-45093. ’ Resp. Ex. 165 at 43. - SOAH DOCKET NO. 503-14-1342.MD PAGE 27 PROPOSAL FOR DECISION drug to “wash-out” of the patient’s body. Dr. Levin disagreed that failing to have a wash-out period constituted a standard of care violation, because the term “wash-out” and Staff alleged that Respondent failed to show that the treatments among physicians. were supported by Staff relied a research concept when treating terminally ill cancer patients. irrelevant in a clinical setting, particularly is is meet the basic standard of care requirements rational, credible research on Dr. Fost’s testimony that and general consensus Respondent exposed substantial risk of harm because the drugs or combination of drugs to his patients to a had not yet been studied for safety and efficacy. Dr. Levin disagreed with Staff and asserted that Respondent’s personalized treatment for cancer patients served to create a treatment plan unique to each patient. Dr. Levin’s opinion, personalized therapy is a reasonable medical approach for the treatment of advanced stages of cancer and, when based on the physician’s prior experience, therapeutic rationale, the use of multiple-targeted agents, including advanced stage cancer patients options, as is quite were those patients of the Dr. Levin’s testimony literature, and PB and other cancer drugs, in common for patients who were without curative treatment Clinic.121 was persuasive on this issue. The received conventional treatment that had been unsuccessful. patients In patients, for the As noted by had typically run out of treatment options when they appeared most part, had Dr. Levin, these or had at the Clinic, chosen not to undergo further traditional treatments such as surgery, radiation, or conventional chemotherapy. The patients were made aware in the informed consent forms and in consultation with the treating physicians that the drugs and combinations of drugs could have side both known and unknown. The medical effects, records for the patients contain numerous accounts of discussions between the patients and Clinic personnel regarding side effects being experienced and changes in treatment to deal with those side effects. “wash-out” period so important to Dr. Wetmore setting '21 when treating patients with such Resp. Ex. 165 at 25. is In addition, the research concept of a irrelevant in the private oncology clinic poor prognoses. Accordingly, the ALJs do not find that Staff has established that there PAGE 28 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD was a common failure to make Patients A through G aware of the potential toxicities of the combination of drugs. b. Inadequate Medical Rationale for Treatment with ANP, PB, and/or the Combined Use of Drugs Staff argued that Respondent prescribed nonstandard and unevaluated doses of multiple anti-cancer medications to these patients that went beyond the established approved medications, without an adequate, documented medical off—label use of FDA— rationale. Respondent asserted that the medications chosen were based on one or more of the following factors: (1) type of cancer; (2) stage of cancer and curative options; (3) testing of malignant tissue that identified the affected pathway and medications with potential clinical benefits; (4) blood testing that measures proteins in the blood; (5) past experience and history with medications in the treatment of cancer; (6) case reviews and medical literature; and (7) the physician’s training and clinical judgment. However, Dr. Wetmore maintained that the patients’ medical records did not meet the basic requirements of adequate medical rationale. She asserted that, in her opinion, the medical records must include adequate histological diagnosis and pathologic confirmation of the cancer; an adequate and complete physical examination; a treatment plan clearly stating the drug name, dose, and route of administration and monitoring; and documentation of an adequate medical rationale for nonstandard and unevaluated doses and combinations of cytostatic and cytotoxic medications. As noted above, Dr. Levin disagreed that this standard as advocated the generally accepted standard for private practice cancer clinics. by Dr. Wetmore is He was of the opinion that the standard of care does not require the physician to document that he prescribed a certain drug because it affects a certain pathway because the rationale is understood by medical oncologists. , SOAH DOCKET NO. 503—14-1342.MD PAGE 29 PROPOSAL FOR DECISION In regard to PB, Dr. Burzynski testified that PB affects the group of enzymes that turn off the activity of tumor suppressor genes and thus promote cancer. Levin supported Dr. this testimony, citing to what he considered to be a reliable and authoritative 2002 article in the Journal of Neuro-Oncology entitled “Complete Response of a Current, Multicentric Malignant Glioma With Sodium Phenylbutyrate.” The in a Patient Treated article states, “Phenylbutyrate is a well-tolerated oral agent that shows potential for the treatment of malignant gliomas.”122 ANP adequately treats some cancers, but not others. Dr. Burzynski testified that this The ALJs find testimony to be persuasive. As for the use used today, are of blood tests, the weight of the testimony is that they are less invasive, are less expensive, are quicker to analyze, more commonly and provide a more complete picture of the cancer. Again, Dr. Levin’s testimony appears to be more credible. He pointed out that it is accepted in medical oncology to provide personalized or precision medicine outside of clinical trials even though the use of drugs, such as ANP and PB, have not been tested together. He clarified that without a curative option, physicians in private practice have flexibility in treating terminal patients and greater leeway in prescribing drugs. private practice oncologist would understand the medical much He greater stated that a rationale for the specific drugs prescribed by the Clinic physicians. In addition, the use of blood tests by Respondent during the relevant period appears to find now be a generally-accepted procedure. that Staff has established that there rationale for treatment with c. ANP, PB, was a common Accordingly, the ALJs do not failure to provide adequate medical and/or the combined use of drugs to Patients A through G. Inadequate Medical Rationale for the Evaluation, Diagnosis, and Treatment of the Patients Staff argues that Respondent failed to meet the standard of care because the Clinic did not document an adequate and complete histological diagnosis of cancer and pathologic confirmation, an adequate and complete physical examination, and a mental status exam. ‘22 Tr. Vol. 11 at 166. SOAH DOCKET NO. 503-14-1342.MD PAGE 30 PROPOSAL FOR DECISION Staff asserts that although Patients A through G were given a physical exam on the first day the patients attended the Clinic, and sometimes on the patient’s subsequent Clinic, there was no documentation of a physical exam aimed at the patient’s Visits to the area of concern. Staff argued that Respondent should have performed a physical evaluation of the patients each time a patient presented to the clinic, but that there is no documentation of anyone, licensed or unlicensed, performing physical evaluations of Patients A through G after the first day. were physical exams performed when the patients were discharged from the was inadequate Nor Clinic. Staff asserts to keep these patients’ caregivers apprised of patients’ progress, to monitor for potential side effects from the multiple drugs Respondent was prescribing and that that this practice were initiated during the patients’ time complaints of physical symptoms while present to and at the clinic, to address patients’ at the Clinic. Staff argues that documented Respondent failed perform adequate mental status exams on Patients B, C, D, and G, along with a physical exam each time the patient presented to the Clinic. Respondent’s point, that there is no expert evidence physical examination to be performed at every patient that the standard visit, is of care requires a well—taken. Moreover, the recommended treatment diagnostic studies were routinely ordered by the treating team with the being based on the results of those studies. Staff argues that the standard of care for the treatment of cancer requires an adequate histologic diagnosis and pathologic confirmation before creating a treatment plan or initiating treatment, as testified to of the primary tumor Patients by Dr. Wetmore, because treatment decisions vary based on the location site and the disease advancement. However, as pointed out by Respondent, A through G appeared at the Clinic after having been diagnosed with Stage 3 or 4 cancer and they were There entitled to decline further invasive testing that they did not is want or need. insufficient evidence to establish that the standard of care requires that a physical exam be performed at every visit. The medical records indicate that the treating patient monitored the patient’s condition, discussed drug side effects, aware of the patient’s current condition. There is team for each and otherwise remained no evidence that the Respondent did not know SOAH DOCKET NO. 503-14-1342.MD PAGE 31 PROPOSAL FOR DECISION of the prior diagnosis as well as prognosis of each patient’s disease that he to no instance when any of the patients indicated as to the recommended below, Patient treatment. There time of treatmenta lack of understanding at the was no need for a mental B was accompanied by his personal physician, wife, and Patient treated. Staff pointed exam Patient because, as discussed C was accompanied by his G was accompanied by her mother, each of whom provided sufficient backup if any confusion developed in the mind of the patient about the treatment being recommended.123 As noted above, Patient D failed to establish that there evaluation, diagnosis, was not even treated at the Clinic. was a common failure to provide and treatment of Patients Based on the record, Staff has adequate medical rationale for the A through G. Inadequate Medical Documentation d. Staff argues that Respondent failed to keep adequate, complete, and accurate medical records for these seven patients in violation of the standard of care. As noted available above, Ms. Kloos testified that were not authenticated by the provider many of the medical to ensure the services rendered and appropriately documented, reviewed, and authenticated. Ms. Kloos that the medical records for Patients On incomplete. Dr. made records that were were accurately Wetmore agreed with A through G were inadequate, inconsistent, and the other hand, Dr. Levin testified that the medical records were well- organized, presented a clear picture, and contained all relevant laboratory, imaging, and pathology reports. For example, on October examination. 11, 2010, Patient A had a physical and neuro/psychiatric Although the physician who performed the examination is not named in the examination report, Dr. Valladares signed the Oncology Report on that same date.124 February 7, 2011, Patient the examination is not B had a physical examination. named in the 123 Patients A, E, ‘24 Staff Ex. 5.02.A at 712-716, 791-792. On Although the physician who performed examination report, Dr. Valladares signed the Oncology and F did not brain cancer and therefore did not require a mental exam. Report on that same date.125 PAGE 32 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14-1342.MD On May 11, 2010, Patient C had a physical and neuro/psychiatric Although the physician who performed the examination examination. is examination report, Dr. Marquis signed the progress notes for that same date. There the provider is not named in the 126 evidence in the record as shown above that certain of the records did not have name, although they did have the date the services were provided. However, in each case, contemporary documents indicate that the provider was either Dr. Valladares or The prescription orders Dr. Marquis. compared all had provider signatures some that illegible, but could on other forms where they were to the provider’s signature be clearly identified. Accordingly, the medical records as a whole were adequate to ensure that the services were rendered and by whom they were provided. failed to establish that there Based on the record, the ALJ S determined was inadequate medical documentation for Patients A through G. Individual Allegations Regarding Patient B. On September that Staff 16, 2010, Patient A A, a 67-year-old man, had a CT scan of his abdomen that showed “multiple poorly defined heterogeneously enhancing consistent with metastatic disease.” On lesions within the liver September 27, 2010, Patient the colon and rectum and biopsy of a large polypoid mass most A had a sigmoidoscopy of partially blocking his colon. The pathology report showed that the mass was “suspicious for invasive adenocarcinoma.”127 Dr. Burzynski testified that Patient A had previously declined recommendations of surgery and chemotherapy. A Patient months. suffered is uniformly fatal, date, Patient A had an initial consultation at the Clinic Staff Ex. 5.03.A at 1015-1017, 1062. ‘26 StaffEx. 5.04A 127 Staff Ex. 5.02.A at 616, 639, 641,. Tr. that the cancer from which survival rate being approximately Vol.3 on October A had a physical and neuro/psychiatric examination. ‘25 ‘29 medium oncologist’s local five 128 Patient ‘28 with the He confirmed his at 1353-1355, 1440. at 115—19. Staff Ex. 5.02.A at 718. 7, While 2010.129 it is On that same not clear from the examination report who performed PAGE 33 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14—1342.MD the examination,130 Patient A’s wife testified was examined by Dr. Valladares and Tolib Rakhmanov, who was a research that Patient A associate (RA). Senior Oncologist Dr. Valladares signed a history and physical report dated that same day that diagnosed Patient A with adenocarcinoma of the colon, invasive, with metastases to the liver.131 On October 11, 2010, Respondent recommended that his treatment be initiated with a regimen of PB and hydrocodone for pain.132 Patient A was treated by the Clinic from October 2010, through October 2011. Patient A died on November 4, 2011. Patient A’s wife, testified that Respondent who was present during saw was performing any physical examinations of Patient RA arrived. Rakhmanov, She testified that, whom its discontinuing she did not recall A subsequent to the first day. 133 Complaint, Staff alleges that in April 2011, there was no medical rationale for some of the Patient A’s medications because the radiology imaging of the affected area revealed that the tumor tumor was growing On October started taking 11, Xeloda was shrinking, but that by mid-May 2011 radiology imaging showed larger. 2010, Patient A started receiving 133.134 On October 13, 2010, Patient A (capecitabine).135 Xeloda was placed on hold on October 14, 2010, due a “non—conclusive pathology report of 9/27/10”, but was restarted on October 17, 2010.136 2 October after Inadequate Medical Rationale for Changing Therapy 1. that the but one of Patient A’s Visits at the Clinic, met with them on the first day that they the first day, the only “doctor” they In all 15, visit at the 2010, Patient to On A began receiving Avastin, which he had been taking before his initial Clinic (oral dose of 25 mg/ml). 13° Staff Ex. 5.02.A at 712-716. 131 Staff Ex. 5.02.A at 791-792. 132 Staff Ex. 5.02.A at 718, 791-792. ‘33 Tr. Vol. 5 at 16-22. ‘34 StaffEx. 5.02.A at ‘35 StaffEx. 5.02.A at 720, 810. ‘36 StaffEx. 5.02.A at 492, 721, 807. 718. At the Clinic, Avastin was administered SOAH DOCKET NO. 503—14—1342.MD intravenously (IV) at a dosage of 2.5 mg/kg.137 mild dizziness and generalized weakness.138 On doubled to 5 mg/kg.139 On October 19, 2010, Respondent complained of On October 22, 2010, the Avastin dosage was October 25, 2010, Patient A was discharged home treatment under the care of his local oncologist, Lance Lassiter, to continue the to a visit CT new biopsy indicated A was instructed Patient the to continue In addition, he mass in his colon was was 140 The notes from office MD. same regimen including the PB, Xeloda, and Avastin. directed to start taking Eloxatin (oxaliplatin) if a adenocarcinoma. PAGE 34 PROPOSAL FOR DECISION Patient A’s local oncologist, Dr. Lassiter, from his January 31, 2011 A indicated that the comparison of a CT scan taken on January 28, 2011, on September 16, 2010, showed Patient A had a positive response to the with Patient scan taken On November 8, 2010, On treatment regimen.142 treatment and that the patient no longer experienced pain and fatigue.141 Dr. Lassiter had added Eloxatin (oxaliplatin) to Patient A’s April 11, 2011, Dr. Lassiter discontinued Eloxatin due to intermittent neuropathy, but continued the Xeloda (the dosage of which he wanted to increase) and Avastin.143 On April 26, 2011, Dr. Marquis concurred with Dr. Lassiter’s decision to increase the dosage of Xeloda.144 April 28, 2011, an enlarged nodule in the right upper lobe of Patient A’s lungs On was detected on a CT scan, and was later confirmed on a PET scan taken on August 3, 2011.145 Dr. Wetmore medication regimen testified that, in general, cOmbinations of drugs that are part of the may have to be altered based on the patient’s experience while on the regimen. She stated that reasons for such a change include: (1) the drugs utilized are ineffective; ‘37 StaffEx. 5.02.A 138 Staff Ex. 5.02.A at 724. ‘39 StaffEx. 5.02.A at 727. “‘0 StaffEx. 5.02.A at 728, 845. ‘4‘ StaffEx. 5.02.A at 695-696. “2 at 716, 722. Staff Ex. 5.02.A at 704—705. ‘43 Staff Ex. 5.02.A at 675-676. ‘44 StaffEx. 5.02.A at 750. ‘45 StaffEx. 5.02.A at 599-600, 618-619. SOAH DOCKET NO. 503-14-1342.MD PAGE 35 PROPOSAL FOR DECISION (2) better patient response is desired; (3) patient exhibits intolerance to the medications; untoward side (4) effects occur.146 Dr. Levin testified that the initial treatment of Patient oral and A initiated at the Clinic included Cape (Xeloda and oxaliplatin) and Avastin, which was an NCCN-recommended regimen and was considered standard therapy. 147 Although, in its Closing Argument, Staff pointed to changes in therapy that occurred in August 2011, the only change in therapy set forth in Staff’s Complaint is one in April 2011.148 That change in therapy was made not by Respondent but by Dr. Lassiter, the physician in contact with Patient A who was observing how the patient was responding to the treatment. Dr. Marquis only concurred with Dr. Lassiter that an increase in the dosage of Xeloda was necessary. Accordingly, Staff has failed to establish that Respondent had an inadequate rationale for changing the therapy in April 2011. Unnecessary Oxygen Saturation Measurements 2. Staff asserts that Respondent directed the unnecessary oxygen saturation as the patient had no significant pulmonary Dr. Wetmore saturation level Patient A’s care.149 is a disease. testified that cancer in one part of the multiple organ systems, including the lungs. way to evaluate oxygen saturation However, Staff has level She agreed lung function. was not measurement of Patient A’s body has the that potential to affect measuring a patient’s oxygen Nevertheless, she stated that measuring useful, relevant, or appropriate to guide his clinical failed to point out any testimony by Dr. Wetmore to explain the basis of her opinion. “6 147 Tr. Vol.3 at 52- 53. Resp. BX. 165 at 42. 148 See Tex. Gov’t Code § 2001.052. Even if the issue had been included in the pleadings, the record indicates that the change in therapy on August 29, 2011, was based on concerns raised by Dr. Lassiter during his office visit with Patient on August 22, 2011. Staff Ex. 5.02.A at 648-650, 785-789. A ‘49 Tr. Vol. 3 at 71-72; StaffEx. 68.03 at 17-18. PAGE 36 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Dr. Burzynski testified that patients with terminal diagnoses and who are elderly often experience pulmonary problems, infections such as bronchitis or pneumonia, pulmonary He embolisms, or cancer that had spread to their lungs. stated that oxygen saturation testing in these patients gives advance notice to the treating physicians of additional problems that could prove fatal. In addition, elderly patients are often respiratory function. Dr. Burzynski testified that pulmonary and the oxygen saturation infections, is why the Clinic routinely tested for whose cancer metastasized 25% test of elderly cancer patients die from helps identify those where they can receive proper treatment transferred to intensive care, This immunosuppressed and have decreased to his lungs. oxygen saturation for the who need pulmonary be to issues. levels in patients such as Patient A, 150 Dr. Levin agreed with Dr. Burzynski that the Clinic used the oxygen saturation test as an “early trip wire” for progressive disease to the lungs or other lung problems that sometimes result from the cancer or Clinic patients its treatment. He stated that while the frequent use of such tests was unusual, he opined that it was not unreasonable, given the on Clinic’s population of very sick patients.151 Based on the testimony of Dr. Burzynski and of Dr. Levin, as well as the general statements by Dr. Wetmore as to the benefits that can be gained to evaluate lung function, the tests ALJs do not find from oxygen saturation that Staff has established that were medically unnecessary—particularly in View of the testing oxygen saturation fact that the cancer had metastasized to Patient A’s lungs. 3. Unnecessary and Costly Laboratory Testing without \Demonstrable Benefit Staff alleges that Respondent ordered and improperly relied upon testing that was unnecessary for Patient A’s cancer. Dr. Wetmore stated that, in most irrelevant to front-line therapy of Patient ‘50 Tr. Vol. 7 at 115-116, Vol. 8 at 95-99. 151 Resp. Ex. 165 at 38. cases, testing was done on genes or A’s colon tumor. She stated proteins that were that gene—related EGFR, SOAH DOCKET NO. 503-14-1342.MD VEGF and Her2 levels (testing for unnecessary because these that “it tests did was already known PAGE 37 PROPOSAL FOR DECISION which was set out in the initial treatment plan) not contribute to decisions in the medical community made for treatment. that mutation were She asserted of a specific gene was not found in his tumor type.”152 In addition, she stated that Respondent improperly based typically treatment decisions on testing results from non-malignant tissue. In her opinion, the tissue testing for the KRAS Respondent’s treatment plan was based on this She asserted that erroneous result.153 She noted that a second biopsy taken later captured malignant tissue showing that the tumor contained the KRAS mutation.154 Dr. Levin testified that the use of the genomic blood and tissue testing much of mutation (a commonly mutated gene in cancer) came back negative because the tissue sample was from a non-malignant tissue specimen. imperative, to obtain as initial results was necessary, if not information as possible about the patient’s tumor and, in particular, to provide guidance as to what targeted drugs to provide the patient. He pointed out that this personalized medicine approach differs from the older protocol approach relied on by Dr. Wetmore. Her approach does not consider that cancers in some patients have characteristics for which there are targeted agents that could be effective, even though not approved or even studied in the patient’s type of cancer.155 The ALJs found Dr. Levin’s testimony most persuasive. He pointed out genomic testing of blood and tissue by Respondent is that the use of necessary to determine what targeted agents should be used. This appears to be the non-conventional method of diagnosis contemplated by the Board Rule at 22 TAC §200.3(1). As for the two tissue samples, occurred as a result of the first test was corrected by the second not find that u: 2 ‘53 ‘4 lII ‘55 StaffEx. 68.03 Tr. v61. 4 may have Accordingly, the ALJs do Staff has established that Respondent used unnecessary and costly laboratory testing without demonstrable benefit in the treatment of Patient A. l test. any error that at at 18. 28-30. StaffEx. 68.03 at 15-16. Resp. Ex. 165 at 45-46. Individual Allegations Regarding Patient C. B was Patient PAGE 38 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14—1342.MD B man who was a 56-year-old diagnosed on December 12, 2010, with glioblastoma, grade IV, a fast-growing, aggressive type of central nervous system tumor that forms on the supportive tissue of the brain. remove as much of the tumor He had debulking surgery on December 20, On as possible. February 7, 2011, Patient physician, Dr. Demetri Brandt, traveled from the Ukraine and with Respondent. Dr. Valladares acknowledged in his care treatment post-debulking is the brain every three months. initial Respondent recommended genetic testing, an B had MRI and his personal to the Clinic to meet oncology report that the standard of Temodar (temozolomide) and an MRI of radiation therapy with Because Patient Germany B 2010, to rejected this conventional treatment, of the head, and administration of PB. Respondent also recommended considering therapy with Afinitor (everolimus), Votrient (pazopanib), Zolinza, Tarceva, and Avastin.156 to the administration of From February 8-17, 2011, Patient B consented PB, Votrient, Avastin, and Tarceva, which were prescribed by Dr. Valladares. On March Dr. Brandt. 4, 2011, Patient He was B left the Clinic and returned to Germany under the care of advised to continue treatment with PB, Votrient, and Avastin, but to PB after four weeks and to start ANP treatments under the supervision of On March 17, 2011, an MRI of the patient’s brain indicated a moderate decrease discontinue the Dr. Brandt.157 that Patient On March 21, 2011, after evaluating the MRI, Respondent B discontinue the PB and start the ANP treatment.159 On July 6 B also consented to the administration of Afinitor, Sprycel (dastinib), of the size of the enhancing recommended through 7, 2011, Patient and Nexavar lesion.158 (sorafenib).160 September 2011. Patient Dr. Brandt stopped treating Patient B died on December ‘56 StaffEx. 5.03.A at 1015—1023; 1062—1064. ‘57 StaffEx. 5.03.A at 1135-37. 15* StaffEx. 5.03.A at 978-979. StaffEx. 5.03.A at 1065. StaffEx. 5.03.A at 897-919. 1” 16° » 18, 2011. B with ANP at the end of Inadequate Medical Rationale for Using ANP 1. made Staff alleges that Respondent ANP outside of a clinical Patient is PAGE 39 PROPOSAL FOR DECISION SOAH DOCKET N O. 503—14-1342.MD trial the treatment recommendation in the B receive or special exception and that, at least as of February 28, 2011, B was receiving ANP in the United States without FDA approval. no rationale that Patient Staff asserts that there medical records for Respondent’s decision to train Patient B and/or his physician in the administration of ANP, or Respondent’s decision to prescribe and provide ANP to Patient B. A physician order dated February 11, 2011, states that Patient antineoplastons/private practice” and the treatment plan Patient that B for a clinical trial for ANP.161 On February Respondent had approval Germany under that Patient “in training for that date includes considering 2011, Respondent wrote a letter stating FDA for use in a clinical trial The letter further states that Patient B would be taking ANP in to use or as part of a special exception. 17, on B was ANP, a drug approved by the Dr. Brandt’s supervision.162 On February 28, 2011, the treatment plan B would continue receiving ANP. However, the actual starting of the administration of ANP was March 21, 2011, when the patient was in Germany.163 Respondent shipped Dr. Brandt in Germany on March 21 and March 7 through August April 11, 2011, and to Patient B states in the ANP to Ukraine from 31, 2011.164 Dr. Burzynski testified that in his initial meeting with Patient B, the patient indicated he was seeking ANP ANP treatment from the under a FDA-approved Clinic.165 He agreed that Patient B was not treated with clinical study or as a single patient protocol, a compassionate exception, or a special exception.166 He testified that the reason for the substitution PB was March he be switched to intravenous that the patient requested in ‘6‘ StaffEx. 5.03.A ‘62 Staff Ex. 5.03.A at 1188. ‘63 StaffEx. 5.03.A 16“ StaffEx. 64.B at 45750-45755. ‘65 1“ Tr. Vol.7 at at at 1021, 1092. 1035, 1041. 176-177. Tr. Vol. 8 at 189. that of ANP for ANP treatment SOAH DOCKET NO. 503-14-1342.MD PAGE 40 PROPOSAL FOR DECISION because he had difficulty tolerating the number of PB tablets he was required to take, and believed by the patient and his local oncologist that intravenous it was ANP treatment would be more powerful and effective.167 The record with ANP. started the is clear that Patient Instead, he was ANP treatment. B initially PB treated with The reference went to the Clinic in order to receive treatment he returned to Germany, where Dr. Brandt until to the continuation of ANP in the February 28, 2011 note referred to training the patient and Dr. Brandt in the administration of March 21, 2011, have a right Board Rule 200.1 complementary and to he was in Germany. As noted above, Dr. Levin testified that patients experience with In ANP in Germany its have a right to seek ALJs find that the request of Patient by the FDA, together with Respondent’s for granting that request. Complaint, Staff alleges that Respondent failed to document an adequate medical March 21, 2011 change discussed above. In addition, Patient from blisters on his hands and its feet, from PB B was to ANP. This issue has been adequately directed to hold Votrient because he which appears to be a valid reason for doing was suffering so.168 Original Brief, Staff argued about changes in therapies that occurred on June 17 and 2011. Again, these addressed. latter two incidents were not included in the pleading and cannot be 169 ‘67 Tr. Vol. 7 at 172-173. ‘68 Staff Ex. 5.03.A at 1041. 169 as allowed ANP, provided sufficient rationale rationale for the 1, that patients clinical trials. This is Inadequate Medical Rationale for Changing Therapy 2. July that “recognizes alternative therapies.” Accordingly, the be treated with In medicine outside of to utilize personalized or precision consistent with B after rather than No Clinic orders indicate that ANP was administered to Patient B actual administering of ANP. until ANP Tex. Gov’t Code § 2001.052. Even if the incidents had been included in the pleadings, the records indicate that the change in therapy adopted by Respondent on June 17, 2011, was based on the genetic testing previously discussed as well as progression of the tumor. Staff Ex. 5.02.A at 1060-1061; Tr. Vol. 7 at 174—175. As for the change on July 1, 2011, the physician order signed by Dr. Marquis indicates that the change was recommended by Dr. Burzynski, who testified that the change was again based on the genomic testing. Tr. Vol. 7 at 175-176. PAGE 41 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Misrepresentations to United States Customs Agents 3. Customs agents Staff alleges that Respondent misrepresented to United States Patient B was being February 17, 2011 letter with treated ANP an FDA-approved in Whom was addressed “To It May Concern” and The study. clinical that stated that Patient B ANP in Germany under Dr. Brandt’s supervision. It also stated that Respondent to use ANP in clinical trials and on a special exception basis, which was true. would be taking had approval While it does not say that Patient basis, a reasonable B was in such a clinical trial or on such a person could conclude that such a representation was the purpose for including the statement in the letter in the first place. However, there Patient B did not need to be in a clinical in that the On special exception FDA did not require that trial give it its in order for was no harm done because Respondent to ship ANP to Germany, approval for shipments of ANP to Germany. the other hand, Respondent did ship ANP which to the Ukraine, a location to FDA regulations to export ANP.170 Dr. Wetmore agreed that Respondent did not need FDA approval to ship APN to Germany, but opined that he violated the FDA protocols when he exported them to the Ukraine.171 Respondent was not allowed by Respondent points out that this issue was the subject of a query by the FDA inspector. Specifically, in his 2013 investigation report, Inspector Joel Martinez discussed the procedure by ANP which Respondent exported entered into a study protocol. to physicians outside the country The document does not whose patients were not indicate that the shipments to Patient B were part of this discussion.172 Respondent further points out that Thomas N. Moreno, Acting Office for 17° StaffEx. 65, Vol. 13.09D.02. at 45686—45687. ‘71 StaffEx. 68.03 at 33; Tr. v. 3 ‘72 StaffEx. 65, Vol. 14.09L.09. at Warning Director of the Office of Compliance of the Center at in the 149-151. 46082-46085. Letter dated Office of Scientific December 3, 2013, Investigations of the Drug Evaluation and Research of the FDA, did not PAGE 42 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14—1342.MD include the export of ANP outside the country as a violation.173 Accordingly, the ALJs find that FDA concerns regarding exports of ANP to unauthorized countries that were resolved to the satisfaction of FDA (as indicated by the fact that Mr. Moreno did not reference the issue raised any by Mr. Martinez) cannot alone serve as the basis of any violations within the scope of this case. Unnecessary Oxygen Saturation Measurements 4. For the same reasons as set forth in Section IV(B)(2) above, specifically due to the benefits that can be gained from oxygen saturation testing to evaluate lung function, the ALJs do not find that Staff has established that the tests were medically unnecessary. Unnecessary and Costly Laboratory Testing without Demonstrable Benefit 5. genomic Staff alleges that the unnecessary and costly ordered had no demonstrable Dr. Valladares conventional treatment, Respondent Sciences (Caris). On March 2, benefit. recommended testing of Patient Because Patient B had B that rejected genetic testing be performed by Caris Life 2011, Caris reported on several tests ordered by Dr. Valladares These included a C-Kit mutational analysis from a formalin-fixed paraffin- for Patient B. embedded tumor sample.174 Dr. Wetmore testified that this test was improperly performed from a plasma specimen because the specimen should have been from the tumor tissue.175 In that testified that same report, Caris reported the results HER2 VEGF and tests are present in the blood. In addition, Dr. Patient B’s Wetmore opined Dr. Wetmore that this type of testing was irrelevant to tumor type.177 EGFR, HER2, and plasma VEGF by necessary under the personalized medicine concept. StaffEx. 12 at 7136-7164 . 17“ StaffEx. 5.03.A at 997. ‘75 StaffEx. 68.03 at 27. ‘76 StaffEx. 5.03.A at 989-1002. “7 HER2 tests.176 not tests on oncogenes but tests on normal proteins Dr. Levin testified that the testing of ‘73 of VEGF and StaffEx. 68.03 at 27. He stated that the Caris tests Caris were examine the SOAH DOCKET N O. 503-14-1342.MD PAGE 43 PROPOSAL FOR DECISION genetic and molecular changes of a patient’s tumor so that treatment options may be matched to the tumor’s molecular profile. In his opinion, Respondent used these tests as a diagnostic tool and never meant them to be the only basis for the treatment prescribed.178 For the same reasons as because these tests set forth in the discussion in Paragraph B3 above, specifically appear to be the non-conventional methods of diagnosis contemplated by the Board Rule 200.3(1), the ALJs do not find that Staff has established that Respondent used unnecessary and costly laboratory testing without demonstrable benefit in the treatment of Patient B. Individual Allegations Regarding Patient D. Patient C was a 42—year-old man who was C diagnosed with Stage II A nodular sclerosing On Hodgkin’s disease in 1986, for which surgical and radiotherapy were successful. April 19, 2010, Patient C was recommended chemotherapy May diagnosed with cancer in his in April 2010. Patient From May 14 through 11, 2010.179 19, Dr. Marquis prescribed the administration of PB C left lung. Patient then chose to consult with the Clinic on 2010, pursuant to Dr. Joshi’s directions, (in combination or concurrently with) the medications Avastin, Decadron (dexamethasone), Nexavar, and Tarceva. discharged home on May 20, 2010, with directions C’s oncologist from Dr. Marquis 180 Patient to continue the C was regimen of PB, Tarceva, Nexavar, Avastin, and Decadron under the care of Dr. Thomas Waits, his local oncologist.181 1. Failure to Document May 14, Staff alleges that Respondent failed to 2010 Office Visit document Patient C’s and that an outpatient physician order for treatment with ‘78 Resp. Ex. 165 ‘79 StaffEx. 5.04A at 1353-1355, 1440. “‘0 StaffEx. 5.04.A at 1436-1439. ‘8‘ StaffEx. 5.04.A at 46, at 50-51. 1578-1580. May PB had no 14, 2010 office physician’s visit, name or signature. However, the Progress Notes on and patient’s Vitals signature appears that direct that the administration same date signed by Dr. Marquis of PB would did not document the May is begin that day. Dr. Marquis’s 14, 2010 visit failed to establish that Respondent with Patient C. Inadequate Medical Rationale for Changing Therapy On November who indicate the 182 on both the Progress Notes and the Physician Order. Based on the above-referenced documents, Staff has 2. PAGE 44 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD 17, 2010, Respondent recommended to Sheryl Acelar, a research associate not licensed to practice medicine in the United States, to change Patient C’s regimen by decreasing the PB, adding Zolinza (panitumumab), based on a high document an adequate Patient C’s cancer (vorinostat), EGFR rationale for this symptoms appeared However, as discussed above, genomic Staff alleges that Respondent failed to result.183 change in therapy, particularly in to given for this change—based on a high and switching Avastin for Vectibix light of the fact that have been improving. Staff argues that the rationale EGFR result test results from a plasma sample—was inadequate. provide an adequate rationale for treatment decisions. On December 6, 2010, Patient C reported to the Clinic that he had a rash on his forehead and around his nose, and that he was going to see Dr. Thomas Waits, his local oncologist, 84 address the problem.1 determine if the On December 9, 2010, Patient C’s Wife contacted the Clinic to Vectibix dosages should be reduced as suggested by Dr. Waits. Ms. Acelar informed Dr. Waits that the Vectibix dosage should be reduced, which Dr. Waits Although Staff did not allege in its violation, clearly the rationale for the 1m 2 StaffEx. 5.04.A at 1245, 1439. 00 3 StaffEx. 5.04.A at 1432-1433. 1 so 4 StaffEx. 5.04.A at 1370. 1 00 5 Staff Ex. 5.04.A at 1430-1431. 1 The Complaint that this did.185 specific change in therapy was a change was to resolve the rash. issue regarding to RA Acelar’s giving medical directions is discussed below. SOAH DOCKET NO. 503-14—1342.MD be PAGE 45 PROPOSAL FOR DECISION On March 9, 2011, Dr. Waits contacted the Clinic to report that the Vectibix appeared to causing Patient C to have diarrhea.186 On March 11, 2011, a teleconference was held with Respondent, Dr. Joshi, Dr. Marquis, and Patient C. Respondent recommended starting Alimta (pemetrexed), discontinuing the Vectibix, and considering a surgical evaluation.187 last administered Vectibix on March 14, 2011. indicate that he did not understand until He began the in its March administration of Alimta on Complaint this specific Patient C start its Subsequent communications from Dr. Waits 18, 2011, that Vectibix May 2, 2011.189 was to be discontinued.188 Again, although Staff did not allege change in therapy was a violation, clearly the rationale for the change was to resolve the patient’s diarrhea. Finally, in Dr. Waits 1 Complaint, Staff alleged that after April 2011, Respondent directed that other substances, including Nexavar, Tarceva, Avastin, PB, and Decadron, without providing a medical rationale for the addition of each drug. However, Staff has not pointed to any documentation in the record to indicate such changes in therapy were made. In addition, it is clear from the record that Dr. Marquis prescribed PB, Decadron, Nexavar, Tarceva, and Avastin to Patient C from May 1 ac 6 StaffEx. 5.04.A at 1427. 1 no 7 StaffEx. 5.04.A at 1390. “‘8 StaffEx. 5.04.A at 1425, 1502. 9 StaffEx. 5.04.A at 1493, 1501. 1 00 14 through 20, 2010, well before April 2011. SOAH DOCKET NO. 503—14-1342.MD PAGE 46 PROPOSAL FOR DECISION Unnecessary and Costly Laboratory Testing without Demonstrable Benefit 3. This allegation has been previously discussed in Section IV(B)(3) above, and for the same reasons, the ALJs do not find Respondent used unnecessary that Staff has established that and costly laboratory testing without demonstrable benefit in the treatment of Patient C. Individual Allegations Regarding Patient E. Patient D D was a 28-year-old male who was diagnosed on May cancer, specifically pleomorphic xanthoastrocytoma, grade resection. with brain which he had a surgical for Imaging studies taken on November 26,2010, showed new lesions were present in his On brain and spine.190 Temodar, an oral April 6, 2011. It January 10, 2011, Patient D’s oncologist recommended treatment with chemotherapy drug, and was stopped due to adverse Due to adverse that, radiation, which treatment was continued through low sodium reactions (abnormally reactions to conventional treatment, Clinic for a consultation, during opined II, 13, 2010, on June in the blood).191 2011, Patient 7, D visited the which Dr. Joshi conducted an oncology assessment. Dr. Joshi absent any further progression of the cancer, Patient current treatment with Temodar. Should future scans D should continue with his show progression, Dr. J oshi indicated that he would recommend a second-line standard of care treatment with Avastin.192 On Patient D July to 1, 2011, after receiving the results of Caris tests, 93 be treated with Tarceva, Afinitor, and Avastin.1 Respondent recommended Patient D declined to follow Respondent’s recommendations and no further treatment was considered. 1. Improper Billing for Dr. Weaver’s Services Staff alleges that Respondent improperly billed for services provided The medical records for Patient ‘90 Staff Ex. 5.01.A at 423-430. ‘91 StaffEx. 5.01.A 1” ‘93 at 383, 453-458. StaffEx. 5.01.A at 387. StaffEx. 5.01.A at 370, 417, D do not show any such billings.194 by Dr. Weaver. SOAH DOCKET NO. 503-14-1342.MD PAGE 47 PROPOSAL FOR DECISION Unnecessary Oxygen Saturation Measurements 2. For the same reasons as Section IV(B)(2) above, specifically due to the set forth in benefits that can be gained from oxygen saturation testing to evaluate lung fimction, the ALJs do not find that Staff has established that the tests Unnecessary and Costly Laboratory Testing without Demonstrable Benefit 3. On were medically unnecessary. June 7, 2011, Respondent ordered Profile On acid level, and Caris testing.195 June 7, 111, HERZ, VEGF, EGFR, C-KIT, amino 2011, Patient D agreed in writing to undergo the various tests including blood and urine analyses, nuclear medicine tests, scans, and x-rays that the Clinic ordered so that the physicians could develop a treatment plan.196 This allegation has been previously discussed in Section IV(B)(3) above, and for the same reasons, the ALJs do not find and costly laboratory that Staff has established that testing. E Individual Allegations Regarding Patient F. Patient E was a 67-year—old male with chromophobic type renal cell carcinoma (kidney cancer) with multiple recurrences which visit Respondent used unnecessary who was first seen at the Clinic on September 7, 2011, during he had an oncology consultation with Dr. Yi. Dr. Yi recommended treatment with Sutent to be followed with Afinitor if Patient E’s cancer progressed. Xeloda (capecitabine) plus Gemzar (gemcitabine) combination was reported to work in renal recommended that Patient E be cell StaffEx. 5.01.13 at 464—465. ‘95 StaffEx. 5.01.A at 373-376. ‘96 StaffEx. 5.01.A at 312. ‘97 StaffEx. 5.05.A at 1619-1625. combination was an option because carcinoma. On that same date, this Respondent evaluated for appropriate personalized treatment including the consideration of Sutent, Afinitor, and Xgeva.197 ‘94 in Dr. Yi also noted that SOAH DOCKET NO. 503-14-1342.MD Rather than follow Dr. Yi’s recommendation, Patient recommendation. Patient E began On September receiving PAGE 48 PROPOSAL FOR DECISION 8, 2011, Patient E chose to follow Respondent’s E began receiving PB; on September Xgeva (denosumab); on September 14, 2011, Patient 13, 2011, E began E receiving Afinitor; and on September 15, 2011, Patient E began was discharged from On October 4, 2011, Patient E informed the Clinic on September 15, 2011. Respondent’s Staff that he had discontinued the all treatment of Patient 1. E on October PB receiving Sutent.198 Patient because of a skin rash. Respondent stopped 16, 2011.199 Non-Therapeutically Prescribing Combinations of Two Targeting Agents Staff alleges that there recommendation that Sutent is no rationale in Patient E’s medical record for Respondent’s and Afinitor (everolimus) should be taken at the same time rather than in succession as Dr. Yi recommended. Staff asserts that the untested combination of these drugs brought with it the risk of unknown dlugs, including the risk of renal failure. side effects caused by interactions Staff further alleges that there is between these no documented medical rationale for prescribing PB. In her expert report, Dr. prior drug (Votrient) that was irresponsible for Wetmore noted Patient E had already experienced toxicity with a had similar tyrosine kinase parameters as Sutent. She opined Respondent to prescribe that it combinations of those agents without proper monitoring and documenting of toxicities.200 Dr. Burzynski testified that a 2009 report of a study conducted by a team at Memorial Sloan Kettering Cancer Center showed that the combination of Sutent and Afinitor showed positive responses for patients with renal cell carcinoma. He stated that because the prescribed combination of the two targeting therapy agents had previously been demonstrated to be ‘98 StaffEx. 5.05.A at 1632-1638. ‘99 StaffEx. 5.05.A at 1605-1608. 20° StaffEx. 61.A.01 at 45087-45088. PAGE 49 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD of cancer, effective in patients with this type it was proper to prescribe them in combination to Patient E.201 Dr. Levin explained that Afinitor that its concurrent treatment with Sutent where no standard approach existed. principles of personalized medicine is an active drug in chromophobe renal was reasonable He opined in a situation that prescribing the cell cancer and such as that of Patient E two drugs followed the and could not in any way be represented as having no medical rationale.202 The testimony of Dr. Levin and Dr. Burzynski constitute sufficient evidence that the combination of the two drugs had therapeutic validity for Patient E. However, Dr. Wetmore’s report makes clear that the medical records particularly in light of the prior problems Patient Therefore, on that aspect alone, the care, in violation of 22 TAC § there ALJs find that E had failed to meet the standard of the prescribing of PB set out in that section, the is set forth in Section IV(A)(5)(b) above. ALJs do not find that Staff has established that for treatment of Patient E with PB. Inadequate Medical Rationale for Prescribing Multiple Targeting Agents 2. Staff alleges that there recommendation concurrently. E with the similar drug, Votrient. Respondent was a failure to provide adequate medical rationale Patient risk factors related to Sutent, l65.1(a)(5). The discussion regarding For the same reasons do not document the is no rationale in Patient E’s medical record for Respondent’s that the four targeting agents (Sutent, Afinitor, Dr. Wetmore opined that the four-drug Xgeva, and PB) should be taken combination Respondent prescribed to did not have sufficient peer—reviewed scientific evidence to establish safety and efficacy. In her opinion, Respondent failed to allow a washout period, which was needed if the 2‘“ Tr. Vol. 7 at 233-234, 237. 202 Resp. BX. 165 at 58-60. SOAH DOCKET NO. 503-14-1342.MD PAGE 50 PROPOSAL FOR DECISION drugs were administered at the same time, and improperly documented adverse events.203 Dr. Burzynski justified his treatment by referring to a 2001 Johns Hopkins study showing that the use of PB in combination with other agents stabilized renal carcinoma in three of six patients in the study.204 Again, because Patient E had experienced prior problems with Votrient, Respondent should have documented that he reviewed the risk factors in prescribing Sutent in combination with the other targeting agents. Therefore, on meet the standard of care in violation of 22 ALJS find that Respondent this issue, the TAC failed to § 165.1(a)(5). Inadequate Informed Consent 3. For a general discussion of the issue of informed consent, see Section VI(B). Staff alleges that Respondent failed to obtain informed consent from Patient E for the simultaneous intake of Sutent and Afinitor. The prescriptions for Afinitor and Sutent were signed on September 13, 2011.205 The informed consent form for Afinitor was signed that day, while the signed informed consent for Sutent until was dated September September 14, 2011, 14, 2011.206 As noted above, and Sutent was not administered the Afinitor until was not administered September 15, 2011, both after the signing of the informed consent forms. The first paragraph of the informed consent for Afinitor states that the information about treatment with Afinitor and other unnamed agents. document contains The “purpose of the treatment” section in the form describes Afinitor as a kinase inhibitor indicated for the treatment of patients with advanced renal 203 20“ StaffEx. 68.03 at 53-55. Tr. Vol.7 at 231-233. 205 Staff Ex. 5.05.A at 1645. 20" StaffEx. 5.05.A at 1786-1791. cell carcinoma after failure of treatment with Sutent or sorafenib. The “purpose of the treatment” PAGE 51 PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14-1342.MD section in the Sutent form describes Sutent as an oral multi— kinase inhibitor also indicated for the treatment of patients with advanced renal cell carcinoma.207 Staff asserts that the informed consents that were signed for these medications do not take into account the potential side effects from the medication’s being taken at the same time, but only address side effects that could be attributed to the drugs being taken individually. argues that the statement in the forms that “the regimen might involve risks of which currently aware” at the is we Staff are not not enough to explain the dangers of taking two untested chemotherapy drugs same time. Dr. Wetmore opined that the standard of care required that “[t]he informed consent process should be completed after [the physician’s] discussion with the patient; and as part of that discussion, the side effects, risks, benefits and alternatives should be relayed to the patient, and the informed consent should be signed prior to the order to give any medication.”208 Dr. Levin testified that it is not necessarily an obligatory practice to obtain consent for a combination of drugs for several reasons. Medications are often used concurrently in everyday when practice even combinations. full toxicity He was of the profiles are not well-worked and without patient consent to opinion that separate consents for concurrent use of Sutent and Afinitor are sufficient.209 The ALJs agree with Dr. Levin concurrently is, represented that that separate in general, within the standard it should be used if treatment informed consents for two drugs used of care, the Afinitor informed consent form with Sutent failed. That statement was misleading because treatment with Afinitor began before the administration of the Sutent, were administered together. This treatment of Patient E 207 20" 209 StaffEx. 5.05.A Tr. Vol.6 at 1786—1791. at 10. Resp. Ex. 165 at 60-61. is clearly a deviation after which they from the procedure SOAH DOCKET NO. 503-14-1342.MD indicated in the Afinitor form that was signed by the patient, and there Respondent or a qualified person explained the purpose for simultaneous use of both agents. PAGE 52 PROPOSAL FOR DECISION As a result, Patient is nothing to indicate that this deviation and for the E was not given the opportunity to give his informed consent to that simultaneous use. Accordingly, the ALJs find that Staff has established that Respondent is in violation of 22 TAC § 190.8(1)(I). Unnecessary Oxygen Saturation Measurements 4. For the same reasons as set forth in Section IV(B)(2) above, specifically due to the benefits that can be gained from oxygen saturation testing to evaluate lung function, the ALJs do not find that 5. Staff established that the tests were medically unnecessary. Unnecessary and Costly Laboratory Testing without Demonstrable Benefit On September 7, 2011, Respondent recommended that Patient B have the following tests: “Profile 111, VEGF, EGFR, HER-2, C-Kit, B12, PSA level, TSH, and amino acid assay.” 210 This allegation has been previously discussed in Section IV(B)(S) above, and for the same reasons, the ALJs do not find that Staff established that Respondent used unnecessary and costly laboratory testing without demonstrable benefit in the treatment of Patient E. Individual Allegations Regarding Patient G. On cancer. September 21, 2009, Patient F, The treatment recommended by F a 66-year-old male, was diagnosed with pancreatic his oncologist was chemotherapy. wife chose to consult with Respondent and the treatment team 21° StaffEx. 5.05.A at 1623—1625. at the Clinic Patient on October F and 8, his 2009. SOAH DOCKET NO. 503-14-1342.MD PAGE 53 PROPOSAL FOR DECISION The treatment plan developed by the team and presented by Dr. Weaver on recommended treatment with PB on October 10), time, Patient Dr. (started on October 9), Rapamune with that date grapefruit juice (started Zolinza (started on October 11), and Xeloda (started on October 13.) At the F was also being treated for a herpes outbreak with Valtrex. Weaver increased Patient F’s Valtrex dosage.211 On October 14, On October 9, 2009, the dosages of and Xeloda were increased, Avastin with premedication of Benadryl and Decadron were and Nexavar was scheduled On 2009, started, to begin the next day.212 October 19, 2009, Patient F was discharged Rapamune, Zolinza, Nexavar, Xeloda, and home with Avastin.213 On his treatment plan of PB, October 23, 2009, Patient F complained that he had been nauseous and dizzy for the previous two days.214 November 13, On 2009, a progress note states that “The patient wants to discontinue our treatment due to financial constraints. He received his 1. PB last dose of [PB] on 11/11/09.”215 Inadequate Documented Medical Rationale for Valtrex in Treatment In her report, Dr. chemotherapy and PB Wetmore stated that it was a violation of the standard of care to initiate while Patient F was having an active herpes outbreak for which he was being treated with Valtrex. She opined that Respondent should have waited until the herpes outbreak had cleared up and Patient F had enough time to wash out the Valtrex before initiating Respondent’s treatment plan.216 her opinion as to why an However, Dr. Wetmore did not provide any scientific basis anti-viral for medication had to wash out before the administration of the anti-cancer targeting agents. 2“ Patient F was being treated with Valtrex for a herpes outbreak prior to visiting the Clinic. Staff Ex. 6.01.A 2032-2035; 2049; 2066; 2071. 2‘2 “3 StaffEx. 6.01.A at 2047. StaffEx. 6.01.A at 2044. 2 4 StaffEx. 6.0l.A at 2084-2085. 2H5 StaffEx. 6.01.A 2‘6 StaffEx. 61.A.01 at 45090. ._. at 2041. at SOAH DOCKET NO. 503-14-1342.MD AS PAGE 54 PROPOSAL FOR DECISION discussed above, based on the opinion of Dr. Levin, a wash—out period is irrelevant in a clinical setting. Accordingly, Staff has failed to establish that the initiation of anti-cancer drugs while Patient F was being treated with an anti-viral medication was a violation of the standard of care. Unnecessary Oxygen Saturation Measurements 2. For the same reasons as set forth in Section IV(B)(2) above, specifically due to the evidence of benefits that can be gained from oxygen saturation testing to evaluate lung function, the ALJs do not find that Staff has established that the tests were medically unnecessary. Unnecessary and Costly Laboratory Testing without Demonstrable Benefit 3. On October 8, HER 2, VEGF, EGFR, 2009, Dr. Weaver recommended numerous C-Kit, MRI, and an echocardiogram. CA 15-3, ammonia level, PSA, a full tests, including Profile body PET/CT scan, a III, head 217 This allegation has been previously discussed in Section IV(B)(3) above, and for the same reasons, the ALJs do not find that Staff has established that Respondent used unnecessary and costly laboratory testing without demonstrable benefit in the treatment of Patient F. Individual Allegations Regarding Patient H. Patient G G was a 26—year-old woman who was diagnosed with cancer and malignant astrocytoma of the optic nerve on July August 3, mass brain 2012. She underwent surgery on 2012, and received treatment with Avastin on August 24, 2012. Her plan of treatment after surgery included radiation therapy by her oncologist 2‘7 5, suprasellar and Temodar (temozolomide). Patient that the adverse side effects Staff Ex. 6.01.A at 2032-2035. G was informed of the recommended conventional treatment SOAH DOCKET NO. 503-14-1342.MD PAGE 55 PROPOSAL FOR DECISION * included edema, headaches, and probable blindness. Patient G determined not to follow this recommendation. G went to the Clinic on August 31, 2012. Respondent recommended that she be for ANP in a single patient protocol.218 The checklist for inclusion in Respondent’s Patient evaluated ANP study under protocol BT-O9 states that she was ineligible to participate in the clinical trial for ANP because she had previously received chemotherapy.219 On September 4 and 5, 2012, Respondent submitted an application to request permission for approval for Patient G to receive ANP under a single patient protocol, which was approved by IRB and the FDA on September 6, On September 2012.220 6, 2012, Respondent submitted Patient G’s informed consent document for the single patient protocol to IRB, which was approved on that date.221 Inadequate Medical Rationale for Use and Promotion of ANP 1. On September day of the ANP Nevertheless, her dosage was 12, 2012, the first discomfort, and fatigue. 222 reported adverse fatigue, headaches, and “pressure.” potassium levels. Dr. infusion, Patient increased. Tests Marquis increased her Decadron (a G reported dizziness, On September 14, showed she had abnormally low steroid) dose, which had initially decreased, back to her original dosage and prescribed a potassium supplement.223 reported on September 15, 2012, having Dr. Marquis increased dosages of Decadron.224 On September 2‘8 StaffEx. 7.01 at 2434-2438. 2‘9 StaffEx. 7.01 at 2469-2470. 22" StaffEx. 7.01 at 2461-2467. StaffEx. 7.01 at 2449-2461. 2“ 222 StaffEx. VOl. 7.01 at 2534. 223 StaffEx. VOl. 7.01 at 2532. 22“ StaffEx. VOl. 7.01 at 2531. ANP edema 2012, she in both feet been Patient and increased blurred G vision. and potassium and maintained the dosage of 16, 2012, she reported similar symptoms and again Dr. Marquis SOAH DOCKET NO. 503-14-1342.MD increased the ANP PAGE 56 PROPOSAL FOR DECISION and potassium dosages. She continued to have abnormally low potassium levels.225 On September headaches. The 17, 2012, Patient edema was G reported that her vision was getting worse, as were her present and worsened at night and with activities. Dr. Marquis still advised her to elevate her feet and monitor for pain in the back of her calves. were both increased on and getting worse, that her eye pain increased her potassium and still September that day. 18, 2012, Patient G ANP and steroids reported that her vision was and headaches remained unchange <1.226 ANP. On September 19, 2012, she reported Dr. Marquis having no eye pain but had blurred vision in her right eye together with agitation and increased anxiety. Pursuant to Dr. Yi’s direction, Dr. Marquis recommended that one of the types of ANP and potassium be increased. On September 20, 2012, a note signed by Dr. Yi stated that she was doing much had no anxiety or agitation, had no eye pain in her right eye, but still had blurred vision in her ANP be increased. On Dr. Yi again recommended that one type of the ANP be increased. left eye. her Dr. Yi recommended that one type of the remain off the receive more Decadron via IV STAT. On September home, Dr. Marquis instructed her dosage of Decadron for her headaches.227 StaffEx. Vol. 7.01 2“ StaffExs. Vol. 7.01 StaffEx. Vol. He instructed her to ANP that she had not taken since September 23, to decrease her potassium, and to the Clinic to go 227 September 21, 2012, On September 22 and 23, 2012, Dr. Yi recommended that she stop taking the ANP due to increased potassium level. On September 25, 2012, Dr. Marquis counseled with Patient G and her mother about her edema, which she reported was decreasing. 225 better, 701 at 2530. at at 2528; Vol. 33 2520-2534. at 22528. 26, 2012, since she to stay off ANP was planning to leave and prescribed an increased SOAH DOCKET NO. 503-14-1342.MD The next day up in the night Patient G was admitted to a hospital in the patient’s home city after waking with extreme leg pain. The hospital staff attributed medications.228 PAGE 57 PROPOSAL FOR DECISION Over the next two days, Patient G’s leg pain it to an adverse reaction to her and edema went away. Patient G ANP on September 29, 2012. On October 2, 2012, her lower extremity pain returned. The edema steadily increased as Patient G increased the ANP dosage over the next few days, and restarted she remained on the elevated steroid dosage.229 On October 19, 2012, Patient G was instructed by Clinic staff to hold ANP due to her reporting having severe bilateral knee and lower leg pain. Staff told her to go to the emergency room of the she restart On hospital in her home city for assessment. ANP, which she did.230 October 26, 2012, Dr. Marquis told Patient G’s mother that a recent significant tumor growth and if the tumor grew terminated from the protocol. On November edema. On October 22, 2012, Dr. Yi directed that 1, On more than 50%, October 28, Patient G G G might have to be stopped taking the ANP due to her 2012, Dr. Marquis noted that the Clinic had received the radiology imaging showing that the tumor had grown 33%. Patient treatments.231 Patient Patient MRI showed G elected to continue with the ANP discontinued treatment at the Clinic on November 26, 2012, due to persistent edema.232 Dr. testified that the standard of care for Patient G’s cancer Wetmore surgical resection followed Avastin. She opined that by radiation therapy with Temodar (temozolomide), with adjunctive Respondent violated the standard of care when Patient receive this first-line therapy.233 22* 2” StaffEx. v61. 7.01 at 2813-2821. StaffEx. V01. 7.01 at 2513-2519. 23° StaffEx. VOl. 7.01 at 2512-2513. 23‘ StaffEx. VOl. 7.01 at 2507-2510. 232 StaffEx. v61. 7.01 at 2502. 2” StaffEx. 68.03 at 64-65. was optimal G did not SOAH DOCKET NO. 503-14-1342.MD In December 2012, PAGE 58 PROPOSAL FOR DECISION G began treatment in her home town with radiation, Temodar Patient and Avastin.234 The patient’s records indicate that she experienced edema, severe headaches, and other severe side effects, including a hospital admission with sepsis, while on this first-line conventional treatment regimen.235 Staff‘s allegation raises the issue of whether the patient has the right to continue an alternative treatment that does not appear to treatment the side effects of which are The preface to 22 TAC § 200.3 be working rather than undergo a conventional known and clearly adverse—in this case total blindness. states the following: A licensed physician shall not be found guilty of unprofessional conduct or be found to have committed professional failure to practice medicine in an acceptable manner solely on the basis of employing a health care method of complementary or alternative medicine, unless it can be demonstrated that such method has a safety risk for the patient that is unreasonably greater than the conventional treatment for the patient’s medical condition. In this case Staff has not established that the safety risk for Patient G in following the ANP treatment was unreasonably greater than that of the conventional treatment. diagnosed with a terminal illness; attributable to the alternative medications she decision to stop them. The G was she was aware of the adverse effects of conventional treatment; and despite the effects of edema, blurred vision, and headaches, to her disease, she continued to Patient some of which were was receiving and some of which were choose to follow the alternative treatments ALJs agree that Patient attributable until she made the G had full knowledge of the consequences of her decisions and that Respondent did not violate the standard of care by following her wishes. 2. Unnecessary Oxygen Saturation Measurements For the same reasons as set forth in Section IV(B)(2) above, specifically due to the benefits that can be gained from oxygen saturation testing to evaluate lung function, the ALJs do not find that Staff established that the tests were medically unnecessary. 23“ StaffEx. 7.01 at 2830. 235 StaffEx. Vol. 701 at 2823; 3030-3033. SOAH DOCKET NO. 503-14-1342.MD Improper Billing and Collection Practices 3. In PAGE 59 PROPOSAL FOR DECISION its Complaint, Staff alleged that Respondent rejected donations made to Patient G’s website, refused to credit those donations against Patient G’s account, and returned the donations to the donors. Staff further alleges that Respondent refused to refund Patient G’s insurance company that were paid to Because Staff did not address No. 34 the allegation 1. is deemed Summary of ALJs’ to Patient G’s account. this allegation in its closing arguments, pursuant to Order be waived. Analysis Based on the above discussion, the ALJs do not find the standard of care payments received from that Staff established violations by Respondent on the following grounds: (1) failing to make Patients of A G aware of the potential toxicities of drug combinations, (2) failing to provide adequate medical rationale for treatment of Patients A through G with ANP, PB, and/or the combined use through of drugs, (3) failing to provide treatment of Patients Patients A A through G. adequate medical rationale for the evaluation, diagnosis, and through G, or (4) providing inadequate medical documentation for Therefore, the ALJs find that Staff failed to show that Respondent violated the standard of care in the treatment of Patients A, B, C, D, F, or G. In regard to Patient E, the ALJs find the standard of care: (1) Respondent failed to of the prior problems Patient § 165.1(a)(5), and (2) E had Respondent that Staff did establish the following violations document the of risk factors related to Sutent in light with the similar drug Votrient, in violation of 22 failed to explain the reason for the deviation TAC from the purpose of treatment explained in the Afinitor informed consent form and failed to give Patient E the opportunity to give his informed consent to the simultaneous use of Afinitor and Sutent, in violation of the rule at 22 TAC § 190.8(1)(I). SOAH DOCKET NO. 503-14-1342.MD V. PAGE 60 PROPOSAL FOR DECISION INADEQUATE DELEGATION AND IMPROPER USE OF UNLICENSED PRACTITIONERS Staff alleges that Respondent improperly delegated medical tasks to “individuals were unqualified and to Staff, . . . unauthorized to perform the task he delegated to them.”236 According Respondent improperly delegated the treatment of cancer patients who practitioners who lacked the necessary oncology training or expertise. to licensed Staff also alleged that Respondent aided and abetted foreign-trained physicians in the unlicensed practice of medicine in violation of Code §§ 157.001,237 l64.052(a)(17), and 164.053(a)(8) and disciplinary action under Code § 164.051(a)(6). The ALJs and is subject to Respondent disputes these allegations and points out that they are inconsistent with Staff’s allegation that he the Clinic. (9), was the sole decision-maker at will address the allegations regarding the licensed physicians first before proceeding to unlicensed practitioners. A. Licensed Providers Staff asserts that Respondent failed to adequately supervise the Clinic’s licensed physicians who were allegedly unqualified or inadequately trained to practice oncology. In Dr. Wetmore’s opinion, Dr. Gregory Burzynski, an internist, overstepped his training and qualifications by making oncology treatment decisions and prescribing anti-cancer drugs to Patient B.238 She also accused Respondent of allowing Dr. Marquis to prescribe anti-cancer 236 Staff‘s Closing 237 Code Argument at 46. § 157.001 states the following: A physician may delegate to a qualified and properly trained person acting under the physician’s supervision any medical act that a reasonable and prudent physician would find within the scope of sound medical judgment to delegate if, in the opinion of the delegating physician: (a) (1) the act: (A) can be properly and safely performed by the person to (B) is performed (C) is not in violation of any other statute; and in its whom the medical act is delegated; customary manner; and person to whom the delegation is made does not represent to the public that the person authorized to practice medicine. (Emphasis added). (2) the . 238 StaffEx. 68.03 at 25-26. . . is SOAH DOCKET NO. 503-14—1342.MD PAGE 61 PROPOSAL FOR DECISION drugs and to treat patients with malignant cancer, when, in her Opinion, Dr. Marquis was not qualified to do As 50.239 a threshold legal issue, Respondent objects to Staffs claim that he is responsible for medical acts provided by other licensed physicians at the Clinic.240 that the Code does not impose a duty on one physician vicariously He argues licensed physician to supervise another licensed who is exercising their own clinical judgment Respondent in the treatment of patients. agreed that he had input into patients’ treatment plans, but stressed that the Clinic’s oncologists evaluated, approved, and implemented the treatment plans.241 Respondent also argues that the Clinic’s licensed physicians were medically qualified by training and experience to provide medical care patients at the Clinic an were assigned a team of health care providers internist or family practitioner; research associates, to the Clinic’s patients. and a research The associate.242 is a board—certified internist who University Medical School in Krakow, Poland, for four years. Southwestern Seton Family in Austin, Texas. for a month his residency, Dr. 2010. He was that included an oncologist, licensed physicians, not the made treatment decisions and issued orders for patients,. Dr. Gregory Burzynski worked As previously discussed, at MD. As studied at the Jagiellonian He completed part of his residency, Dr. Anderson Cancer Center in Gregory Burzynski an elective oncology Gregory Burzynski joined his father’s practice his residency at rotation.243 at the Clinic in the After summer of licensed by the Board in January 2011.244 Dr. Gregory Burzynski has done his CMEs at the Society of Neuro-Oncology for the past four years.245 23" StaffEx. 68.03 24° Respondent’s Closing Arguments at 37. at 28. 2‘“ For example, Dr. Valladares signed Patient A’s treatment plan. Patient F’s treatment plan. Staff Ex. 6.01 .A at 2035. 2“ Tr. Vol. 7 at 81-82. 2‘” StaffEx. 24" Tr. Vol. 10 at 46. 245 StaffEx. 66.GG at 4-5; Tr. 66.GG at 5. Vol. 10 at 8-9. Staff Ex. 5.02.A at 845. Dr. Weaver signed SOAH DOCKET N O. 503-14-1342.MD PAGE 62 PROPOSAL FOR DECISION Dr. Gregory Burzynski testified that he was responsible for treating associated internal He medical problems that arose during a patient’s cancer treatments.246 explained that when evaluating a patient’s treatment options, the team assigned to that patient discussed the patient’s medical history and treatment options, but the oncologist on the team made the treatment decisions. Dr. Gregory Burzynski agreed that he Dr. Valladares was the assigned oncologist. was involved He in Patient B’s care, but stressed that pointed out that Patient physician from Germany, Dr. Brandt, to the Clinic.247 B Patient B’s wife brought his personal was also a physician. According to Dr. Gregory Burzynski, he participated in taking Patient B’s history and in reviewing the informed consent forms with the patient and Dr. Brandt. During their conversations, Dr. Gregory Burzynski stated he paid attention to Patient B’s language, behavior, and questions, as well as state.248 In Dr. how he interacted with everyone, to evaluate the patient’s mental Gregory Burzynski’s opinion, Patient them about the anti-cancer drugs recommended B and Dr. Brandt understood what he told in the treatment plan.249 Dr. Marquis has an undergraduate degree from the College of Pharmacy at the University of Texas in Austin. He completed medical school at the University of Texas Medical Branch in Galveston, Texas, and did his residency at Central Texas Medical Foundation at Brackenridge Hospital in Austin.250 He is a family physician and originally had his own practice in Austin. After his father-in-law developed prostate cancer, Dr. Marquis stated, he closed his practice and moved closer to the Dallas/Fort Marquis and his family Worth area moved to Houston, He continued to work there until 2014.252 2“ Tr. Vol. 10 at 11. 2‘” Tr. Vol. 10 at 33. 2"“ Tr. Vol. 10 at35. “9 Tr. Vol. 10 at 35—36. 25° Tr. Vol. 13 at 5. 25‘ Tr. Vol. 13 at5. 252 Tr. Vol. 13 at 6. to help him. When his father-in-law improved, Dr. Texas, and he began working at the Clinic in 2006.251 SOAH DOCKET N O. 503-14—1342.MD According to Dr. Marquis, he received on-the-job training oncologist and did not part PAGE 63 PROPOSAL FOR DECISION make oncology at the Clinic, but is not an treatment decisions.253 Dr. Marquis agreed that he was of the team assigned to Patients C and D, but clarified that his role was to assist the oncologist in monitoring and communicating with the patients, to ensure the Clinic received the requested labs and scans in a timely manner, and in managing “toxicities.”254 practitioner at the Clinic, Dr. As a Marquis said that he “had better and easier contact with the my hands to be able to communicate with them, and you know, them as long as they needed me to make sure everything was going well.”255 patients, more time on . Dr. Marquis testified that attend the initial consultation. patient and documented his FDA 2” PB was said, he would Respondent told the not FDA-approved to treat their type of he conducted the patient’s physical examination and was done the day the patient arrived Typically, Dr. Marquis said, the at the Clinic.257 FDA-approved medications in his experience involved treatment with herbs, creams, in a non- and Vitamins, but did 258 Dr. Marquis said that when a patient who did not any anti-cancer medications. to take anti-cancer drugs learned that the Clinic did not provide alternative treatment, they usually left the Clinic.259 254 that Marquis this meeting, Dr. Clinic provided gene-targeted treatments using which 'not include 2” During to care for a patient approved manner, Dr. Marquis explained. The Clinic did not provide alternative cancer treatment, want when he was assigned to a team confirmed speak to . findings in the patient’s medical records. physical examination The .. their family, if present, that Dr. Marquis cancer.256 family Tr. Vol. 13 at 7. Tr. Vol. 13 at 9. Tr. Vol. 13 at 9. 256 Tr. Vol. 13 at 13-14. 257 Tr. Vol. 13 at 15. 258 Tr. Vol. 13 at 12. 259 Tr. Vol. 13 at 13. SOAH DOCKET N O. 503-14-1342.MD Before Patient diagnosed Patient Dr. Marquis C C PAGE 64 PROPOSAL FOR DECISION arrived at the Clinic, his local oncologist in Indiana, Dr. Waits, with mesothelioma. The diagnosis was confirmed in a pathology report.260 confirmed that Patient C was informed that PB was not FDA—approved for his cancer and was informed about the potential side effects of the various anti-cancer agents that were being proposed for treatment. 261 When Patient C returned home, Dr. Marquis recalled, Dr. Waits continued the treatment regimen.262 This indicated to Dr. Marquis that Dr. Waits had “looked to at the logic behind the treatment plan that was put together” at the Clinic and found “it be sound.”263 Dr. Marquis emphasized that he was not Patient C’s oncologist 4 decisions concerning changes to the oncology treatments.26 Once and did not make the oncologist made a decision about what medications to give the patient, Dr. Marquis explained, the oncologist told Dr. Marquis what mediations to order.265 patient, ensure that the “[l]ab He would manage the side effects experienced and scan reports” were done, review the results, by the and share the information with Dr. Waits.266 Although some of Dr. Wait’s communications with the Clinic were addressed RAAcelar as “Dr. Acelar,” Dr. Respondent and Dr. to Tr. V01. 13 at 27-28. 26‘ Tr. V01. 13 at 34-35. it passed on the information to would “not be right” if RA Acelar failed Tr. Vol. 13 at 23-24. 263 Tr. Vol. 13 at 24. 26“ StaffEx. 66.11 at 112. StaffEx. 66.11 at 2“ Marquis agreed that that she inform Dr. Waits that she was not a licensed physician.268 26° “2 J oshi.267 Dr. Marquis confirmed to 112-113. 266 According to Dr. Marquis, Dr. Valladares typically wrote his own prescriptions, but Dr. Joshi did not. Dr. Joshi had Dr. Marquis prepare and sign the prescriptions. Staff Ex. 66.11 at 115. 267 2“ StaffEx. 66.11 at 109. Staff Ex. 66.11 at 109. Dr. Marquis did not 7, remember Patient D because the patient elected not to be treated at After reviewing the patient’s records, Dr. Marquis agreed that he prepared the the Clinic. June PAGE 65 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14-1342.MD 2011 consultation note in which he summarized the Caris genetic report and Respondent’s treatment recommendations.269 Dr. Marquis denied that he wrote any prescriptions for this patient.270 Dr. Marquis performed Patient G’s August 31, 2012 physical examination and was responsible for the patient’s history and physical report.271 Patient G Dr. Marquis maintained that did not require a mental status examination because the patient was reiterated that he did not make the oncology treatment decisions. alert.272 He Because Patient G’s local oncologist treated Patient G’s side effects, Dr. Marquis said that he just documented the information in the medical record.273 ALJs’ Analysis Regarding Licensed Providers B. Code § 157.001 allows a physician to delegate medical acts to a qualified and properly trained person acting under the physician’s supervision if a reasonable would find such acts appropriate to delegate. not “represent to the public that the person The is statute and prudent physician goes on to provide that this person authorized to practice medicine.” The may Clinic’s licensed physicians, specifically Dr. Gregory Burzynski and Dr. Marquis, were and are licensed by the Board acts to practice medicine. issue then 269 StaffEx. 66.11 at 134, 139. 27° StaffEx. 66.11 at 139. StaffEx. 66.11 at 272 Tr. v61. 13 at 40. 273 StaffEx. 66.11 at for the medical § 157.001. becomes whether Respondent violated Code §§ 164.051(a)(6) and 164.053(a)(8) and (9).”4 274 was not responsible performed by Drs. Gregory Burzynski and Marquis under Code The 2" Therefore, Respondent The credible evidence indicates that Dr. Gregory Burzynski and 139-140. 148-149. Code § 164.051(a)(6) allows the Board to discipline a physician for failing to “practice medicine in an acceptable professional manner consistent with public health and welfare. Code § 164.053(a)(8) and (9) clarify that SOAH DOCKET N O. 503-14-1342.MD PAGE 66 PROPOSAL FOR DECISION Dr. Marquis had the training and expertise to participate in providing the medical services they provided to the Clinic’s patients. Both physicians were assigned to work with an oncologist and a research associate in the treatment of specific patients, and assisted the oncologist in the treatment of these at the Clinic patients. Dr. Gregory Burzynski and Dr. Marquis credibly testified that they did not make oncology treatment decisions, but deferred such decisions to the Clinic’s oncologists and Respondent. patients was Their contribution to the team of health care professionals assigned to specific conduct and document the patient’s history and physical examination, write to prescriptions, ensure laboratory results participate in discussions options. and scans were timely received and reviewed, and and conferences with the assigned oncologist regarding treatment In addition, they were responsible for treating side effects caused by the anti-cancer medications, such as diarrhea and increased blood pressure, and monitoring a patient’s progress on treatment. Drs. Gregory Burzynski and Marquis also maintained weekly contact with the patients and the patients’ local oncologists once the patients returned home and reported any side effects the patient experienced to the appropriate oncologist. Based on the credible evidence, the ALJs find Dr. Marquis were qualified they performed. by training, experience, Because Staff Respondent improperly delegated were unqualified to perform, the failed to Gregory Burzynski and and licensure to perform the medical acts prove by a preponderance of the evidence that to either physician ALJs find that Dr. medical responsibilities or acts that they that in regards to the licensed physicians discussed above Respondent did not engage in unprofessional or dishonorable conduct as defined in Code § 164.053(a)(8) and (9). unprofessional conduct likely to deceive or defraud the public includes a physician’s failure to adequately supervise those under the physician’s supervision and delegating to a person professional responsibilities or acts that the physician knows or should have known the person is unqualified to perform by training, experience, or licensure. . PAGE 67 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Unlicensed Practitioners C. The United Clinic’s research associates were often foreign-trained doctors unlicensed in the Respondent hired the research associates and supervised many of States.275 their Staff alleges that Respondent misrepresented the qualifications of the following activities. unlicensed foreign-trained physicians to the Clinic’s patients, their families, and local and improperly allowed them oncologists, Mohammed Khan, Tolib Rakhrnanov, Larisa Tikhomirova, Sheryll Acelar, and Lourdes DeLeon.276 Staff asserts that the medical records for Patients to practice medicine: A through G reflect that these research associates practiced medicine by ordering medications, diagnostics tests, and laboratory tests without any documented input of a licensed physician; made treatment recommendations; and interacted with patients and other medical personnel without clarifying medicine in Texas. According to were authorized to practice Staff, that they were not licensed by allowing the research associates to practice to represent that they medicine and improperly delegating medical acts to them that they were unqualified to perform, 164.053(a)(8) and (9). Respondent violated Code §§ 157.001, l64.052(a)(17)277 and Patient F, Patient F’s wife, Patient A’s wife, and Dr. Lassiter (Patient A’s local oncologist) testified that the Clinic’s research associates were held out to be licensed medical However, Patient A’s wife also agreed physicians. husband did not do anything without first talking that the research associate assigned to her to Dr. Valladares or Respondent.278 testified that he did not think that the research associate assigned to his case, made treatment decisions. 279 However, he estimated discussed issues about his treatment with 275 that about 80% RA Tikhomirova, of the time, he met and Tr. Vol. 7 at 81-82. To avoid confusion between the licensed physicians and the unlicensed foreign-trained physicians, the use the abbreviation “RA” rather than “Dr.” before their last names. 277 According to Code § 164.052(a)(1 7), a physician practice medicine by an unlicensed person. 279 28° F RA Tikhomirova.280 276 278 Patient Tr. Vol. 5 at 74-75. Tr. Vol.4 StaffEx. at 152-153. 66.AA at 6. is ALJs will prohibited from directly or indirectly aiding and abetting the SOAH DOCKET NO. 503—14—1342.MD Patient F acknowledged , that he signed the informed consent forms that discussed with him, but could not remember what because it was too long ago. He RA Tikhomirova said that he thought he something that could damage his health.281 Patient told would remember F acknowledged informed consent forms before signing them, but he should have.282 may the drugs she told him about if he did not read the RA Tikhomirova was not If was “the main one that even though he assumed Respondent was treating him.284 Wetmore conceded Dr. consent, ”283 RA Tikhomirova him about that a licensed doctor, he stated that he would feel “misled” because she doctored me, PAGE 68 PROPOSAL FOR DECISION that certain aspects be properly delegated to of patient care, such as obtaining informed someone other than a licensed physician.285 However, because the research associates signed consent forms on the signatory line for the physician, she opined that the Clinic’s patients were misled into believing that the research associates were licensed physicians.286 This misrepresentation associates them to was reinforced, she noted, because the research were addressed as “doctor” and wore white lab coats with a name tags identifying be doctors. In Dr. Wetmore’s opinion, Respondent did not tell families, or the patients’ local oncologists that the research associates result, the patients, the patients’ were unlicensed.287 As a she concluded that Respondent failed to properly supervise the research associates, improperly delegated medical tasks to them, and aided and abetted them in the unlicensed practice of medicine. Dr. Levin disagreed that the research associates were practicing medicine. that a physician is the person 28‘ StaffEx. 66.AA at 39. 2’” StaffEx. 66.AA at 37. 283 StaffEx. 66.AA at 54. 2 00 4 StaffEx. 66.AA at 86. 2“ 28" 287 Tr. Vol.3 who “synthesizes the data and makes a diagnosis, He explained offers treatment, at 124. StaffEx. 68.03 at 88, 94. In Staff’s Reply Brief, Staff asserted that Respondent violated Code § 104.004, part of the Healing Art Identification Act. However, Staff did not include this allegation in its Second Amended Complaint. The Texas Government Code § 2001 .052(a) requires that the notice of hearing include, among other things, a “reference to the particular sections of the statutes and rules involved.” Therefore, allegations regarding the Healing Art Identification Act it will not be addressed further. ‘ SOAH DOCKET NO. 503-14-1342.MD PAGE 69 PROPOSAL FOR DECISION none of the Clinic’s carries out treatment that’s actually practicing medicine.”288 In his opinion, Therefore, he research associates participated in decision-making roles regarding patient care. opined, they were not practicing medicine.289 Dr. Levin also pointed out that it is not uncommon for a person with a doctorate degree to be addressed as “Doctor.”290 Dr. Burzynski testified that during the initial consultation patients were introduced to the oncologist, internist or family practitioner, and the research associate assigned as their health care team. He explained who were unlicensed.291 to patients that that the research associates were foreign-trained doctors Dr. Burzynski emphasized that research associates had no independent decision-making authority regarding the diagnoses and treatment of Clinic patients and pointed out that even Dr. Wetmore agreed that the medical records do not prove that any unlicensed person made treatment decisions.292 Dr. Marquis patients confirmed that the Clinic’s research associates stayed in contact with and acted as an intermediary between the physician and that required a physician’s input, Dr. Marquis stated patient.293 If there that the research associate was an issue took notes, consulted a physician and/or oncologist, and informed the patient about the physician’s . . deCISlon. 2 94 Dr. Marquis denled that the research assoc1ates practlced med1c1ne.295 . According oncologists 28“ 2” to Dr. by serving Tr. Vol. 11 at 169. Resp. BX. 165 at 69. 29° Resp. Ex. 165 29‘ Tr. v61. 7 at 80-82, 214. 2” Tr. Vol.6 at 69. at 83. 293 Tr. v61. 13 at 37-39. 29“ Tr. Vol. 13 at 39-40. 295 Tr. Vol. 13 at38. 296 Tr. v61. 10 at 17. . . . . . Gregory Burzynski, the research associates supported the Clinic’s as their scribes and communicating with patients.296 As foreign medical SOAH DOCKET NO. 503—14-1342.MD ' had a wealth of medical knowledge and were very competent.297 In doctors, he pointed out, they his opinion, the research associates freed issues.298 PAGE 70 PROPOSAL FOR DECISION up the oncologists’ time so they could focus on medical While a physician was ultimately responsible maintained that non-physician medical professionals for the patient, Dr. made valuable Gregory Burzynski contributions and recommendations regarding a patient’s treatment without engaging in the practice of medicine.299 In contrast to Patients A’s and F’s experience at the Clinic, Margaret Manning, a former Clinic patient, testified that the research associate assigned to her case told her that she licensed physician was not a and could not make treatment decisions or write prescriptions.300 Mary Susan McGee, another Clinic patient, stated that that she knew the research associate, RA Rakhmanov, was not a licensed physician and served as a “communicator.”301 He received instructions from the licensed physicians. According to Ms. McGee, RA Rakhmanov did not provide medical treatment to her and did not prescribe any medications.302 Mary Michaels, the mother of a pediatric working on her son’s team told her States.303 Mary Jo that they patient, testified that the research associates were licensed in Poland, but not in the Siegel, another Clinic patient, testified that research associate took her Vitals and asked her how when she arrived at the Clinic a she had been doing.304 She were foreign—trained physicians who were unlicensed in the United United States. knew that they They did not diagnose or treat her cancer. The background, allegations, separately addressed below. 297 Tr. Vol. 10 at 18. 29" Tr. Vol. 10 at 19. 29" Tr. Vol. 10 at 26-27. 30° Tr. Vol. 13 at 95. 30‘ Tr. Vol. 11 at 16-17. 302 Tr. Vol. 11 at 16-17. 303 Tr. Vol. 10 at 145. 30“ Tr. Vol. 10 at 155. and evidence regarding each research associate are SOAH DOCKET NO. 503-14-1342.MD Tolib 1. RA Rakhmanov Rakhmanov attended medical school and practiced medicine in Tajikistan, but unlicensed in the United States. and left in July 2016.305 He began working for the Clinic as RA Rakhmanov, that he usually worked with Dr. Valladares.306 the Clinic divided the research associates RA Rakhmanov is a research associate in 2006 His job duties included collecting the patient’s medical history and obtaining the patient’s prior medical records before the patient patient. PAGE 71 PROPOSAL FOR DECISION insisted that If a patient decided to came among to the Clinic. According to the licensed physicians and he never performed the physical examination of a Clinic be treated at the Clinic after consulting with the licensed physicians, he gave the patient the informed consent forms for each prescribed treatment medication and then discussed with the patient information about the medications and what was on the informed consent form.307 Dr. Wetmore focused on the medical records involvement in the evaluation and treatment of Patients A,308 the medical records reflect that documented RA Rakhmanov’s B,309 and 0310 She reported that that she said RA Rakhmanov took patient histories, signed orders, reviewed laboratory results, oversaw the infusions, obtained informed consents from the patient, and corresponded with the patient’s local oncologist. Such practice of medicine. 3“ StaffEx. 66.H at 4. 306 StaffEx. 66.H at 24. 307 StaffEx. 66.H at 9. 30" StaffExs. 5.02; 33.5. 309 StaffExs. 5.03A; 33.1. 3 ._. ° StaffExs. 5.04; 33.7. she maintained, constitute the Further perpetuating the misconception that licensed physician, Dr. and he was permitted activities, Wetmore pointed to out, the Clinic referred to RA him Rakhmanov was as “Dr. a Rakhmanov,” wear a white lab coat with a name tag identifying him as a doctor. In SOAH DOCKET NO. 503-14-1342.MD her opinion, Respondent allowed PAGE 72 PROPOSAL FOR DECISION RA Rakhmanov to engage in the unlicensed practice of medicine.311 RA “Dr. Rakhmanov agreed that colleagues his Rakhmanov,” but he explained they did so out of respect graduate.312 When a patient arrived licensed physician always taken or the physician saw he at the Clinic, felt it was unnecessary.313 came just When him as for his being a medical school he visited with the said, the patient unless the patient referred to Clinic the at patients have to came patient, but a their vital signs for an infusion, RA Rakhmanov reported, they were directed to the infusion room where the infusions were done under the supervision of Clinic personnel Patient who were 14 “licensed to do infusions.”3 A’s wife and Dr. Lassiter believed he was a licensed physician, He when he Although RA Rakhmanov denied introduced himself to patients he told them that he mislead patients. that he had graduated from medical school in Russia, but that he was not licensed in the United testified that States.315 Patient A is deceased, but his wife was present with Patient A when RA Rakhmanov was introduced to her husband. Patient A’s wife and his local oncologist, Dr. Lassiter, testified that RA Rakhmanov they understood that recalled that RA Rakhmanov assumed he was a Patient RA 3“ Rakhmanov 2010 laboratory as Patient A’s doctors.317 The October StaffEx. 68.03 at 88, 92-94. StaffEx. 66,H at 48. StaffEx. 66.H at 53. 3’5 StaffEx. 66.H at 12-13; w Patient 7 After the initial consultation, test results identify 3‘4 _. 316 Patient A’s October 7 and 13, at 31. 3 and her husband that he was a “GI” doctor, so they A saw at the Clinic was RA Rakhmanov. StaffEx. 66.H OK Patient A’s wife A’s wife confirmed that the only doctor Patient 3 3 .— Patient A’s treating physician. specialist in gastrointestinal cancers. 3 2 _. told her was 31-32. A had colon cancer that had metastasized to his liver. StaffEx. 5.02.A at 584-586. 8 and 11, both Dr. Marquis and 2010 pathology reports indicate that the ordering physician RA Rakhmanov signed as 18 was “Valladares/Rakhmanov.”3 the “Physician performing consent,” on Patient A’s October 11, Statement for PB.319 In a letter 2010 Informed Consent dated October 15, 2010, Dr. Marquis notified Patient “Dr. Tolib Rakhmanov’s” patients were being transferred to Dr. Valladares. instructed Patient A Rakhmanov and Dr. Valladares.”320 October 22, 2010 infusion nurse’s note documented that “Dr. 130/89, instructed to d/c RARakhmanov The A that all of letter further to direct all correspondence “including laboratory studies, scan results, questions, and concerns to both Dr. BP= PAGE 73 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14—1342.MD IV and to home for today.”321 Additionally, the TR [RA Rakhmanov] After Patient A notified of returned home, signed physician’s orders to ship Patient A’s treatment medication to the patient.322 Staff maintains that Patients B RA Rakhmanov engaged in similar conduct in the treatment of and C. Patient B’s medical records show that Dr. Gregory Burzynski told Patient B’s local physician, Dr. Brandt, that “Dr. Rakhmanov” could assist with any questions about RA Rakhmanov also communicated specific dosage instructions for the administration of ANP and Avastin to Dr. Brandt and signed the email as “Dr. Tolib.”324 When Patient B323 Patient B appeared to be dying from complications related to side effects from his treatment regime, Staff asserts, Dr. Gregory Burzynski deferred the treatment decision to as indicated RA Rakhmanov by the signature on the correspondence—“Dr. Tolib Rakhmanov.”325 RA Rakhmanov remembered working on the team assigned to Patient A. He said that Dr. Valladares conducted Patient A’s physical examination, and, together with Respondent, 3 8 StaffEX. 5.02.A at 587-589. 9 StaffEx. 5.02.A at 837-838. 32° StaffEx. 5.02.A at 870. 32‘ StaffEx. 5.02.A at 803. ._. 3 RA 322 Rakhmanov’s orders as the basis for billing Patient Staff expert, Ms. Kloos, testified that the Clinic used the monthly case management fee. This issue will be addressed in Section VIII regarding improper charges. 323 Staff Ex. 5.03.A at 1165. 32“ StaffEx. 5.03.A at 1159. 325 StaffEx. 5.03.A at 1142. A PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD PAGE 74 developed a treatment plan.326 Although he signed Patient A’s order for supplements, he said he did so at Respondent’s direction.327 form for PB on October 11, RA said that he signed the informed consent 2010, but only after the licensed physician explained the benefits and side effects of the medication to Patient RA Rakhmanov Rakhmanov A in his presence.328 stated that the nurse notified him about Despite the infusion nurse’s note, Patient A’s blood pressure, but did not discharge the patient to go home; rather, the nurse did.329 explain Why RA that he Rakhmanov could not Dr. Lassiter thought he created the Patient A’s treatment plan as reflected in Dr. Lassiter’s letter.330 RA Rakhmanov agreed that Patient B was not in a clinical trial event, though the patient received ANP. On July 5 through 7, 2011, RA Rakhmanov signed Patient B’s As for Patient B, informed consent as the physician performing the consents.331 ALJs’ Analysis Regarding Unlicensed Practitioners 2. As noted before, a physician has the authority to delegate medical acts to an unlicensed person under Code § 157.001, but the unlicensed person person is authorized to practice medicine.”332 may “not represent to the public that the Code§ l64.053(a)(8) further provides that a physician’s failure to supervise adequately the activities of those acting under the physician’s supervision constitutes unprofessional or dishonorable conduct likely to deceive or defraud the public. Dr. Levin correctly noted that other professionals the Code defines the word “physician,” 326 StaffEx. 66.H 327 StaffExs. 66H at 30; 5.02.A at 783. 328 Staff Exs. 66.H at 26. 3” StaffExs. 66.H at 39-40; 5.02.A at 836-838. at 55; 5.02.A 3w° StaffEx. 66.H at 60-64. 3w 1 StaffEx. 5.03.A at 897-910. 332 Code § 157.001(a)(2). at 803. it may be addressed as “Doctor.” While does not define “doctor.” Therefore, the context in SOAH DOCKET NO. 503-14-1342.MD which the person setting, is acting when PAGE 75 PROPOSAL FOR DECISION called “doctor” is relevant. A person working medical in a wearing a white lab coat with a name tag identifying the person as “doctor” and addressed by staff as “doctor,” who signs informed consent forms and orders in the space designated for the physician’s signature, and communicates with other health—care providers as though he were a licensed physician, medicine. In a medical setting, is representing to the public that he is authorized to practice RA Rakhmanov presented as a licensed physician, and Patient A, Patient A’s wife, Dr. Lassiter, Patient F, and Patient F’s wife reasonably trusted that RA Rakhmanov was a licensed physician. Respondent was aware, or should have been aware, that patients such as Patients and outside oncologists, such as Dr. Lassiter, believed A and F RA Rakhmanov was a licensed physician because Respondent had access to correspondence and medical documents that evidenced misrepresentation. medical acts to Respondent had an obligation as a physician who supervised and delegated RA Rakhmanov represent to the public that he so. this to ensure that was authorized RA Rakhmanov did not directly or indirectly to practice medicine, and Respondent failed to do By failing to adequately supervise RA Rakhmanov to ensure that he did not misrepresent his licensure, either directly or indirectly, described in Code Respondent engaged in unprofessional conduct as § l64.053(a)(8). Based on the credible evidence, the ALJs 'find RA Rakhmanov, delegated medical acts to RA that Respondent supervised Rakhmanov, and permitted him to be misrepresented as a person authorized to practice medicine in Violation of Code § 157.001.333 By failing to adequately supervise RA Rakhmanov licensure, either directly or indirectly, described in Code Although Code he did not misrepresent his Respondent engaged in unprofessional conduct as § 164.053(a)(8). RA Rakhmanov medicine in violation of Code 333 to ensure that § 151,002(a)(12) represented himself to be a person authorized to practice § 157.001, whether Respondent aided and abetted defines a physician to be “a person licensed to practice medicine RA Rakhmanov in this state.” SOAH DOCKET NO. 503-14—1342.MD in the unlicensed practice term “practicing medicine” PAGE 76 PROPOSAL FOR DECISION of medicine is a different issue. Code § 151.002(a)(13) defines the as: the diagnosis, treatment, or offer to treat a mental or physical disease or disorder by any system or method, or the attempt to effect cures of those conditions, by a person who: (A) publicly professes to be a physician or surgeon; or (B) directly or indirectly charges money for those services. . . . . Patient A’s wife agreed . . that although she believed that RA Rakhmanov was a physician, he would not do anything without instructions from Dr. Valladares or Respondent.334 Ms. McGee, a former patient, confirmed RA that Rakhmanov did not make treatment decisions.335 RA Rakhmanov’s testimony that he relied on the licensed oncologists and physicians to diagnose and treat the Clinic’s patients was persuasive. The evidence does not support a finding RA Rakhmanov was unqualified to perform the medical acts that were delegated to him by Respondent and the other Clinic physicians. Because RA Rakhmanov was performing medical that acts under a physician’s supervision that he was qualified to perform, he was not engaged in the practice of medicine. RA Rakhmanov ' The ALJs find that the evidence is insufficient to establish that engaged in the practice of medicine or that Respondent delegated to him medical acts that he was unqualified to perform. Therefore, Respondent did not aid and abet RAVRakhmanov in the unlicensed practice of medicine as defined in not engage in unprofessional conduct as defined by RA Kahn attended medical school and radiologist for 4 years before 336 and did § 164.053(a)(9). Mohammed Khan 3. States. Code § 164.052(a)(17), moving to the was licensed United States, but in Pakistan. he is He worked not licensed in the United RA Khan has been employed by the Clinic as a clinical research associate since 33“ Tr. V01. 5 at 74-75. 335 Tr. v61. 13 at 95; Vol. 11 at 16-17. 336 StaffEx. 66.E at 16. as a 1997, SOAH DOCKET NO. 503-14-1342.MD primarily working as the Clinic’s radiology technician.337 when radiology scans, but downloaded them RA Khan would see patients into the computer, and the their families, Clinic does not perform worked wanted to see and then showed them RA Kahn its own collected them, to the treating physicians.338 directly with patients since 2000 through 2001, but he their films.339 Wetmore’s opinion, Respondent knew In Dr. asserts that if they The radiology films arrived at the Clinic, said that he has not PAGE 77 PROPOSAL FOR DECISION that RA Khan was identified to patients, patients’ local physicians as a licensed radiologist.340 Specifically, Staff RA Khan practiced medicine by reviewing diagnostic tests, writing radiology reports, and being involved in the evaluation and treatment of patients. Dr. Wetmore testified measurement of tumor of medicine, even if size on radiographic imaging is that “[t]he the practice of radiology and the practice [Respondent] also reviewed and measured after Mohammed Khan to check his work.”341 According to Dr. Wetmore, Patients radiological reports: A through G’s medical records contained conflicting some were performed by independent, unaffiliated performed by unidentified persons at the Clinic. measurements and assessments than those contained agreed that a radiology technician may measure The radiologists and others reports often contained different in the independent reports.342 Although she tumors, particularly if the measurements are verified by a physician, Dr. Wetmore clarified that “the physician needs to remeasure the lesion and absolutely confirm that it is the correct position and orientation to measurement.” She stressed that only the physician the tumor’s size, and she saw no documentation lesions.343 337 StaffEx. 66.E at 338 StaffEx. 66.E 3” StaffEx. 66. 13 5. at 5. at 16, 18. 34° StaffEx. 68.03 at 93-94. 3‘“ StaffEx. 68.03 at 92-95. 3” 343 StaffEx. 68.03, at 16, 22, 30-34, 41, 46-47, 52, 63-64. Tr. Vol.3 at 137-138; Vol. 6 at 83-85. to make a valid may determine if there has been a change show that in Respondent had remeasured the PAGE 78 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD RA Khan agreed that he measured tumors on the films and would share his measurements when they viewed with the physicians making treatment radiology films.344 decisions, Respondent always However, he testified that before measured the lesions himself345 and the physicians typically interpreted the films themselves and waited for the measurements from the outside report.346 Dr. Burzynski testified that he supervised RA Khan and had archived scans and current scans for the physicians for review. RA Khan tumor Later, Dr. Burzynski said, he would RA Khan could write up the report for him.347 busy, RA Khan would “come up with the image; this to make sure that the images were correct.” Drs. Marquis and Weaver confirmed that RA According to Dr. Burzynski, and then I came back and Khan took measurements.”349 Dr. Weaver also said that Respondent rev1ewed RA Rakhmanov reported that: cursory measurements of the Khan According to . [sic] them will doctors, they should was done.3 tell their 1 34“ StaffEx. 66.E at 10. 345 StaffEx. 66.E at 11. 346 Staff Ex. 66.E at 12-13, 23—24. 3‘” Tr. v61. 9 at 56; StaffEx. 66.JJ at 11-12. 34* StaffEx. 66.1] 349 Tr. v61. 13 at 19—20. 35° StaffEx. 66.Q at 35‘ StaffEx. 66.H at 66. at 12-13. 25-27. to his RA Khan’s measurements. 350 show them, I’m going to do from this side of the tumor to this side of the tumor. And then, you know, it’s all computer, you know how tall the measurements are, that it right away gives you the measurements. And then Dr. I 348 Dr. Marquis, Respondent reviewed “every film, every measurement, and adjust . instructed so the computer could and created reports that compared the patient’s scans. lesion locations, retrieve the dictate the radiology notes to so that when he was checked size. Khan The physicians then RA Khan as to which tumors to measure and where to place the cursors calculate the RA opinion, they agree with that or not. That’s how it SOAH DOCKET NO. 503—14-1342.MD What is “being accomplished, person preparing a radiology report is PAGE 79 PROPOSAL FOR DECISION is not what is being done,” Dr. Levin stated, determines practicing medicine.352 If the radiologist is a “scribe” taking dictation from the physician to prepare a radiology report, then the radiologist He practicing medicine, according to Dr. Levin. if the who is not pointed out that radiology technicians are allowed to take the tumor measurements for a physician to use in the physician’s radiology report without it report that to is constituting the practice of medicine.353 be used clinically or in a patient’s ongoing care, not just to physician’s interpretation of a study, he agreed have a medical 4. RA But, if a person creates a radiology facilitate the practice of medicine and the person it is a must license.354 ALJs’ Analysis Khan worked Clinic’s patients. as a radiology technician and Because he had limited contact with health-care providers, the ALJs find was not directly involved with the patients, patients’ families, or outside that the evidence is insufficient to himself out to the public to be a licensed physician. measurements from scans he downloaded RA show that RA Khan held Khan admitted he took tumor into the computer, but Respondent confirmed that remeasured the tumors to verify the measurements. The other physicians relied on their he own review of the radiologic imaging and the official radiology report to make treatment decisions. In addition, Respondent actively supervised RA Kahn while he measured adjusted these measurements to conform to his measurements. Although the lesions and then RA Khan prepared the radiology reports, Respondent dictated what he wanted in the report. Therefore, the that Respondent did not fail to him, and did not aid and abet supervise RA Khan, 3” 35“ Tr. Vol. 11 at9l-92. Tr. Vol. 11 at 195. Tr. Vol. 11 at 92-93. did not improperly delegate medical acts to RA Khan in the unlicensed practice of medicine as set out in Code §§ 157.001, 164.052(a)(17), and 164.053(a)(8) and 3” ALJs find (9). SOAH DOCKET NO. 503-14—1342.MD Larisa Tikhomirova 5. RA Tikhomirova worked at the Clinic as a research associate from July 2009 to 2012.355 She attended medical school outside the United States, but While working histories, maintaining documentation, conducting follow-up and the patient’s According to gathered all RA patients, at the Clinic, local physician, RA Tikhomirova, not licensed in the United visits, communicating with the and issuing certain orders as Respondent when a new directed.357 patient arrived, she took the patient’s history and the medical information and documentation to deliver to the assigned physicians. Tikhomirova agreed she was present during some of the initial consultations with Respondent, and the physicians during which the patient’s disease, diagnoses, and proposed treatments were discussed.358 said that she would If the patient elected to start treatment, issue the orders for lab tests, When the results were received, physicians. sign. After the senior physician signed is May RA Tikhomirova’s job duties included taking the patient States.356 patient PAGE 80 PROPOSAL FOR DECISION PET scans, RA Tikhomirova and MRIs as instructed by the she gave them to the senior physician to review and had signed off on the results, RA Tikhomirova stated, she then it.359 According to RA Tikhomirova, the Clinic had a mandatory policy that only a licensed physician could perform the patient’s physical examination. Once treatment started, if a patient experienced any complications or symptoms arose, the research associates were required to call either the senior physician or the oncologist.360 RA Tikhomirova If the patient said that she might not ask the physician to experienced no health problems, meet with the always the licensed physician’s decision whether to see a patient.361 3“ StaffEx. 66.N at4. 35" Staff Ex. 357 StaffEx. 66.N at 35“ StaffEx. 66.N at 6-8. 3” “0 36‘ 66.N at 87-88. 5. StaffEx. 66.N at 11. StaffEx. 66.N at 16. StaffEx. 66.N at 17. patient, but it was In Dr. PAGE 81 PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14-1342.MD RA Wetmore’s opinion, Respondent aided and abetted unlicensed practice of medicine for Patients B and F by: Tikhomirova (l) permitting her to in the be addressed as “Dr. Tikhomirova”; (2) allowing her to wear a white lab coat with a name tag identifying her as a doctor; and (3) allowing her to take patient histories, sign orders, review laboratory results, oversee the infusion of prescribed drugs, review informed consent forms with patients, and communicate with other health care providers as though she were a According to Dr. Wetmore, Respondent knew and permitted activities similar to those assigned to physician interns The medical records show Patient B that and RA Tikhomirova as the “Physician performing consent” RA treating physician.362 Tikhomirova to engage in residents.363 signed the informed consent forms for on February 7, 15, and 17, 2011.364 She was identified on Patient B’s laboratory results as a doctor, along with Dr. Marquis.365 February 7, 2011, she authorized giving supplements to Patient designated for the physician’s signature.366 radiology orders for an MRI On B and signed on the February 7 and March of Patient B’s brain on the 4, On line 2011, she signed line designated for “Physician Signature.”367 RA Tikhomirova explained that while she reviewed and signed Patient B’s informed consent forms, the team had already reviewed each treatment medication with Patient in Patient B’s “3 36“ Staff Ex. 68.03 at 88, 92-93. StaffEx. 68.03 at 88. StaffEx. 5.03.A at 909-916; 918-919. StaffEx. 5.03.A at 934-948, 959. 3“ StaffEx. 5.03.A “7 at 1086-1087. at 1096, 1187. 3“ StaffEx. 5.03.A 368 Staff Ex. 369 StaffExs. 66.N at 33; 5.03.A at 1056. 66.N at 25-26. his RA medical records as “Dr. Tikhomirova.”369 This included signing the physician order for Aminocare Forte. 362 and Although Dr. Valladares was Patient B’s oncologist, local oncologist, Dr. Brandt.368 Tikhomirova signed documents B RA Tikhomirova explained that Respondent ordered this PAGE 82 PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14-1342.MD supplement for every patient.370 As for the February 7, 2011 radiology RA Tikhomirova said that the physician ordered the MRI for Patient B and instructed her to prepare The entry regarding ANP on February 28, 2011, she explained, was had not yet been prescribed.371 to train Patient B on how to administer ANP even though RA Tikhomirova explained that this was an atypical situation because Patient B and Dr. Brandt order that she signed, it. it were and wanted to be trained while waiting for the in a rush test results.372 RA Tikhomirova was also on the team assigned to Patient F. Patient F and Patient F’s wife testified that they believed that RA Tikhomirova was a licensed physician.373 Patient F’s wife said that RA Tikhomirova saw her husband every day except for a ten-minute meeting that she and her husband had with Respondent and two other male doctors.374 RA Tikhomirova was not a licensed doctor, Patient F’s wife said she acknowledged that the treatment decisions said that she thought that When she learned that felt “duped.”375 She went through the chain of command. However, she RA Tikhomirova managed her husband’s medication regimen because RA Tikhomirova told them how Patient F was going to take the medicine and when to start and 376 stop each treatment series. RA Tikhomirova was the only person at the Clinic who reviewed the informed consent forms with them and then signed where the physician’s signature was indicated.377 RA history Tikhomirova did not remember Patient and took dictation during the RA that while StaffEx. 66.N at 36. 37‘ Staff Ex. 372 StaffEx. 66.N at 55-56. 373 37“ 375 376 consultation with the patient.378 Dr. at 56-57. Vol.4 at 111-112, 118-122, 217-219, 224-226. 4 at 220, 224-225; Staff 13x. 66.2 at 30-38. Tr. Vol.4 at 224-225; Staff Ex. 66.Z Tr. Vol.4 at 226. 4 at 272-273. Tr. Tr. v61, confirmed that she took his medical Tikhomirova wrote the order for supplements, 37° 66.N initial F, but 377 Tr. v61. 37" StaffEx. 66.N at 68. at 31. it was Weaver at testified Respondent’s SOAH DOCKET NO. 503-14-1342.MD directions.379 Patient F’s PAGE 83 PROPOSAL FOR DECISION medical records reflect that on October 15, 2009, she signed Patient F’s On informed consents for Nexavar and Avastin. as the “Physician performing consent.” October 13, 2009, she signed the informed consent for Xeloda, and on October signed the informed consents for Rapamune, PB, and Zolinza.380 On of treatment is 2009, she each consent form, Tikhomirova signed as the “Physician performing consent” on the same page that the “physician in charge 9, Dr. Stanislaw Burzynski.”381 that RA documented The October 15, 2009 daily nursing report stated that “Dr. Tikhomirova” gave the order to proceed with Patient F’s infusion, but explained that she only repeated to the nurse What the senior physician had instructed her to say.382 6. ALJs’ Analysis RA Tikhomirova was called “Dr. Tikhomirova,” she wore a white lab coat with a name tag identifying her as “Dr. Tikhomirova,” and she signed consent forms and orders in the space designated for the physician’s signature. Because she worked RA Tikhomirova presented to the public as a licensed physician. patient records in which at a medical facility, Respondent had access to RA Tikhomirova routinely signed her name in the space reserved for the physician’s signature. Respondent was aware, or should have been aware, that patients such as RA Tikhomirova was a licensed physician. As a supervising physician who delegated medical acts to RA Tikhomirova, Respondent had an obligation to ensure that she did Patient F believed not represent to the public that she was authorized to practice medicine, and he failed to do so. Based on the RA Tikhomirova, credible evidence, delegated medical acts to ALJs find the RA that Respondent supervised Tikhomirova, and permitted her to be misrepresented as a person authorized to practice medicine in violation of Code § 157.001. failing to adequately supervise 379 StaffEx. 66.Q at4l. 38° StaffEx. 6.01.A at 1966-1982. 381 3” Staff. RA Ex. 6.01.A at 1966-1982. StaffExs. 66.N at 78; 6.01.A at 2075. Tikhomirova to ensure that By he did not misrepresent his SOAH DOCKET NO. 503-14-1342.MD licensure, either directly or indirectly, described in It Code PAGE 84 PROPOSAL FOR DECISION Respondent engaged in unprofessional conduct as § 164.053(a)(8). remains to be determined whether Respondent aided and abetted her RA Tikhomirova practiced do to so. medicine and whether In addition to the informed consents, RA Tikhomirova signed orders for lab work and supplements and communicated with Patient F F and and his wife as though she were a physician. But, Patient RA Tikhomirova did not make treatment decisions. Respondent and Dr. Weaver confirmed that she acted under a physician’s supervision insufficient evidence to she show that was unqualified to perform, when she performed medical Respondent delegated medical acts to his wife agreed that acts. RA Staff presented Tikhomirova that or that she performed the medical acts without the supervision of a licensed physician. The ALJs find that the evidence in the practice of medicine or that to perform. is insufficient to establish that Respondent delegated to her defined in §§ 164.052(a)(17), medical acts she was unqualified RA Tikhomirova in the unlicensed and did not engage in unprofessional Therefore, Respondent did not aid and abet practice of medicine as RA Tikhomirova engaged conduct as defined by Code § l64.053(a)(9). 7. Sheryl] Acelar RA Acelar graduated from St. Luke College of Medicine on August 26, 2005. _ Although she practiced medicine in the Philippines, she is not licensed in the United States.383 Respondent hired RA Acelar in 2010 and frecguently gave her instructions on what to do at work even though 84 Dr. Marquis was her supervisor. RA Acelar left the Clinic in 2014. In Dr. Joshi’s opinion, RA Acelar was assigned activities that most interns and residents do, but she did not make treatment decisions—Respondent did.385 383 Tr. Vol. 12 at 18-19; StaffEx. 38“ StaffEx. 66.A at 29, 31. 385 StaffEx. 66.A at 30. 66.C at 4-5. While working PAGE 85 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD at the Clinic, RA Acelar said that she took the patient histories and reviewed the “systems with the patient for a new consultation for both targeted gene therapy and She kept records clinical trial.”386 for the physicians, monitored phone calls, and relayed messages about a patient’s symptomatology in regards to the prescribed medications.387 RA Acelar denied that she ever evaluated and diagnosed the Clinic patients.388 RA Acelar was on the team assigned to treat Patients C and G. held herself out to these patients to be a licensed physician.389 Dr. Clinic referred to name According Wetmore to Staff, she testified that the RA Acelar as “Dr. Acelar” and permitted her to wear a white lab coat with a tag identifying her as a doctor.390 According to Dr. were not practicing medicine, then “they were for, if the research associates certainly participating in the Charade to patients and other health care providers that they were physicians. Respondent was responsible Wetmore, and aided and abetted 77391 Dr. Wetmore maintained that RA Acelar in, the unlicensed practice of medicine.392 When Patient C first came to the Clinic, Dr. Joshi said history, but Dr. J oshi denied that she or Acelar took the patient’s any research associate conducted the According to Dr. Joshi, examinations.393 RA RA patients” physician Acelar was responsible for ensuring that the laboratory results were delivered to Respondent and Dr. Marquis so they could decisions,394 but she did not participate in the patient’s diagnosis or 3“ “‘7 StaffEx. 66.C at 6. StaffEx. 66.C at 6 3“ StaffEx. 66.C at 10. 3” StaffExs. 66.C at 63-64; 66.Q at 35, 56. 39° StaffExs. 66.C at 63-64, 77-80, 109-112; 66.Q at 37; 66.11 at 108-110. 391 StaffEx. 68.03 at 88. 3‘” StaffEx. 68.03 at 94. 3” 39“ StaffEx. 66.A at 85. StaffEx. 66.A at 31. engage make treatment in the practice of SOAH DOCKET N O. 503-14-1342.MD medicine. According to Dr. J oshi, PAGE 86 PROPOSAL FOR DECISION RA Acelar “would never make decisions in regard to treating a patient, absolutely not.”395 Weaver Dr. testified that RA Acelar was called “Dr. Acelar” because she had a medical degree but he agreed that she worked under the supervision of other licensed physicians.396 According to RA Acelar, initialing the time. 398 C before Statement of Informed Consent in the space designated for the physician’s signature as she consents, she reviewed the risks and benefits 'of Avastin with Patient was directed to do by the physicians.397 Before Patient C signed the informed RA Acelar informed him that he had the right to withdraw from treatment at any RA Acelar put her initials on the Clinic’s form entitled “Consent for Pretreatment Evaluation,” where made physicians it called for the physician’s signature.399 She insisted that the licensed the treatment recommendations,400 she only issued orders for radiology scans that the physician ordered. According to what to write. them.401 RA Acelar, Dr. Marquis had her write his progress notes, but he told her After she had written the progress notes, Dr. Marquis reviewed and signed Then, she initialed them. Although she also wrote the order for Patient C’s infiision, RA Acelar said she did so because Dr. Marquis ordered it.402 The ANP Clinic’s billing supervisor, patients and monitored Leann Chiapetta, testified their treatments, did 3‘” StaffEx. 66.A at 32. 396 StaffEx. 66.Q 397 StaffExs. 66.C at 50, 55; 5.01.A at 1222—1224. 39“ StaffEx. 66.C at 50, 55. 3” ‘4‘” at 9-10. StaffExs. 66.C at 13; 5.04.A at 1230. StaffEx. 66c at 20. 4‘“ StaffEx. 66.C 402 Staff Exs. 66.C at 43; 5.04.A at 1246. at 40. office that visits, RA Acelar handled many evaluated the patients, and PAGE 87 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD performed the physical examinations. She clarified that RA Acelar did not make any decisions about the drugs a patient was being given.403 Ms. Chiapetta testified that: [A] lot of time the RA. was responsible for the patient. The RA. would communicate to the oncologist. So the initial physical exam, yes, the oncologist would be there, review them; and then, of course, would get with Dr. Burzynski and they would come up with whatever treatment plan. After that the RA. was responsible for that particular patient. So the RA, RA. would have been usually the oncologist, the see the patient and discuss with the patient in the meeting. It is Dr. Burzynski, they would all and then that was assigned to that particular R.A. from that point.404 Patient C’s local oncologist, Dr. Waits, testified that he thought physician because she identified herself as “Dr. Acelar.”405 RAAcelar was It RA Acelar was a licensed was the contact physician at the Clinic for Patient C. his understanding that According to Dr. Waits, RA Acelar never told him that she was not a licensed doctor.406 On December 9, 2010, an email was sent to RA Acelar at 9:39 am. requesting permission to reduce the dosage before the next infusion four days later. RA Acelar responded in two minutes at 9:41 am, directing Dr. Waits to make the following adjustment to the patient’s treatment: Reduce it to 3 mg/kg and also I will await his [Dr. Waits’s] email/call, thank you. Start him him [sic] on Medrol dose pack and maybe give him 40 mg of Solumedrol IV or IM. This may help with the rash. If he is still on antibiotics, please continue on with it.407 The same day, Dr. Waits responded correspondence not tell 1 an email to “Dr. Acelar” indicating that “[a]s per your will lower his dose to 3 Dr. Waits she was an unlicensed 4‘” StaffEx. 66.Y at 52-55. 4"“ Staff Ex. 66.Y at 74-76. “5 in StaffEx. 66.0 at 46—50, 57—58, 63. 406 StaffEx. 66.C 407 StaffEx. 5.04.A at 1430. 40* StaffExs. 5.04.A at 1430; 66.C at 81. at 63. mg/kg due on 12/13.” physician.408 RA Acelar responded, but did She explained that because he never asked SOAH DOCKET NO. 503.14-1342.MD RAAcelar she if was PAGE 88 PROPOSAL FOR DECISION licensed, she did not volunteer this information.409 According to RA Acelar, Respondent saw this communication and had her respond to Dr. Waits.410 According to Patient G’s medical records, RA Acelar answered an email on October 30, 2012, in response to a question about whether Patient RA supplements. When Acelar replied, okay with “It is Patient G’s local oncologist notified G RA RA me to let her G could take various have these supplements.”411 Acelar that he had decreased the dosage of want her back on ANP as soon as Decadron that Patient possible.” RA Acelar said that the November 1, 2012 note regarding this patient was dictated to received, Acelar wrote, “I her by Dr. Marquis. After he reviewed and signed off on the note, she said that she initialed RA Acelar In that note, it. indicated that Patient G’s scans were reviewed by Respondent, Dr. Marquis, and “Dr. Acelar” with the radiology department.412 ALJs’ Analysis 8. The name Clinic addressed RA Acelar as “Dr. tag identifying her as “Dr. Acelar.” associates, RA As Acelar,” and she wore a white lab coat with a in the previous discussions regarding the research Acelar also signed consent forms and orders in the space designated for the physician’s signature. Unlike the previous research associates, RA Acelar issued treatment orders regarding Patient C, as evidenced by her email communications with Dr. Waits. Patient and Dr. Waits reasonably understood that RA Acelar was a licensed physician. C Respondent and RA Acelar knew or should have known of this misconception and did nothing to correct it. RA Acelar, delegated medical acts to RA Acelar, and was aware, or should have been aware, that RA Acelar represented to the public that she was a licensed physician. Respondent had access to patient records in which RA Acelar routinely signed her Respondent supervised 409 StaffEx. 66.C at 63-64, 74. 41° StaffEx. 66.C 4“ 4 2 ._. at 74-75. StaffEx. 5.01.A at 2839-40. Staff Ex. 66.C at 99 (RA Acelar’s deposition). SOAH DOCKET NO. 503—14-1342.MD name PAGE 89 PROPOSAL FOR DECISION and where she documented her in the space reserved for the physician’s signature treatment decisions regarding Patient C. Respondent had an obligation as a physician who supervised and delegated medical acts to ensure that RA Acelar did not practice medicine or misrepresent to the public that she was liCensed to practice medicine, and he failed to do so in violation of Code§ 157.001. allowed RA Based on the credible evidence, the ALJs find Acelar to make treatment decisions regarding Patient misrepresent that she was a person authorized to practice medicine. RA failed to adequately supervise Acelar and aided and abetted RA C By that Respondent and permitted her doing so, to Respondent Acelar in the unlicensed practice of medicine in violation of Code §§ 157 .001, 164.052(a)(17), and 164.053(a)(8) and (9). Lourdes DeLeon 9. RA DeLeon attended medical school in 1982, and worked for 10 years as a medical doctor in the Philippines.413 She came to the United States in 1996 and began her pediatric RA DeLeon was unable to complete her 414 residency because she had to care for her sick mother. RA DeLeon has worked as a research residency at the University of Kansas Medical Center. associate at the Clinic since 2005.415 According to receiving On ANP unless assistant. oncologist “4 patients on clinical trials or she was the only research assistant at the Clinic emphasized that her function at the Clinic Whatever the oncologist ordered, Tr. Vol. 12 at 6-7. Tr. Vol. 12 at 6-8, 18-19; StaffEx. StaffEx. RA was DeLeon to at 8. 66D at StaffEx. 66.D 16, 21, 23. at 10-11. 66D at 7. who were when the patient arrived. find out what to do.416 work with the oncologist as an said, she carried out made the diagnosis and determined the treatment.417 “5 Tr. V01. 12 “6 4” DeLeon, she did not see the those occasions, she would contact the patient’s physician to RA DeLeon 4‘3 RA because the , Staff accuses RA DeLeon of evaluating and treating Patient E. RA DeLeon took the patient’s history, results, PAGE 90 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14—1342.MD Staff reasons that because signed orders for tests and imaging, reviewed laboratory oversaw infusions, reviewed the informed consents with the patient, and communicated with Patient E’s local oncologist as though she were a treating physician, she was practicing medicine Without a license. RA DeLeon admitted that she wore a white coat with a name tag 418 identifying her as a doctor and Patient E’s informed consent these reasons, Dr. Wetmore was called “Dr.” documents on staff.419 by the Clinic She also signed lines indicated for the physician’s signature. For testified that Respondent improperly delegated medical acts to RA DeLeon and aided and abetted in RA DeLeon’s unlicensed practice of medicine.420 RA DeLeon explained that she served as a liaison between a Clinic patient and the team of physicians assigned to Philippines, United treat that patient.421 Although she a licensed doctor in the is she testified that she understood that because she States, she could not practice medicine. medicine in the United States, and She maintained was unlicensed that she has not practiced that she told Clinic patients that she foreign medical school, but her function at the Clinic was in the was a graduate of a as a research associate, not as a physician.422 RA DeLeon testified that she was present when Respondent explained to her patients that she was not a licensed physician.4 23 During the initial consultation, she said, Respondent introduced her to the patients “as a research associate, as a foreign graduate medical, but not licensed to practice medicine here in 4 8 StaffEx. 66.A 4 9 Tr. V01. 12 at 31-36; StaffEx. 4N0 StaffEx. 68.03 at 88, 93-94. 42‘ Tr. Vol. 12 at 5, 11,20. 4N2 StaffEx. 66.D at28. 4N3 Tr. V01. 12 at 10-11. 4N4 Tr. Vol. 12 at 11. ._r at . . . Texas or the United 28-32, 70, 80-85. 66.D at 27-29, 60-63, 70-71. States.”424 it’s [sic] She said that PAGE 91 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Respondent told patients that her role was as “a liaison between the patient and the physician and . . . as a contact RA — immediate DeLeon contact with the patients and the physicians.”425 recalled that Patient Clinic staff addressed her as Dr. a physician from DeLeon, she testified “working as a research associate and to E was this is that she my function. This New York.426 Although the informed Patient is what I do E that she here.”427 was According RA DeLeon, Respondent and Dr. Yi conferred and agreed on Patient E’s cancer treatment and she documented their discussion. At the treatment plan with Patient initial consultation, E and Respondent 8 taking the medications together.42 she said that Dr. Yi reviewed the explained to Patient Afterwards, RA DeLeon E the risks and benefits of said she reviewed the informed consents with Patient E. When Patient E’s blood tests Dr. Yi and he told her if treatment, she said, Patient E was it results arrived, was okay often PB. could begin taking she showed them to for the patient to start the infusion treatments. On PB and RA DeLeon explained, September 8, both said to do The first 2011, she asked Respondent and Dr. Yi 30.429 Before treatment, RA DeLeon if said she discussed the risks and benefits of PB with Patient E, and then he reviewed and signed the informed consent form. She added that she had previously given Patient he could read them. September 7, DeLeon said that she did not know why her forms so name was on a 2011 radiology note because she was not involved in anything related to radiology.430 “5 RA E the consent Tr. v61. 12 at 11. 4N6 StaffEx. 66.D at 26. 4N 7 StaffEx. 66.D at28. 42* StaffEx. 66.D at 64. 429 StaffEx. 66.1) at 55. 4w ° StaffEx. 66.D at 46. 10. PAGE 92 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD ALJs’ Analysis The ALJs found white lab coat with a RA name DeLeon to be a credible witness. tag identifying her as “Dr. Although RA DeLeon wore a DeLeon,” was called “Dr. DeLeon,” and signed consent forms and lab and imaging orders in the space designated for the physician’s signature, her testimony that she told patients she that she told Patient E was unlicensed was persuasive. She clarified that her function at the Clinic was to assist the Clinic’s physicians follow their instructions, and that appears to be what she did. insufficient to and The evidence presented was show that RA DeLeon made treatment decisions. Although RA DeLeon should have physician’s signature, she made refrained from signing in areas designated for the certain that Patient E was aware that she was not authorized to practice medicine, and she acted only under the physician’s supervision. Staff failed to provide sufficient evidence to establish that she physicians delegated to her. was unqualified Therefore, the ALJs find to perform the medical acts the that credible evidence shows that she performed the medical acts that she was qualified to perform under the direction of a licensed physician and did not misrepresent to Patient 11. Summary of ALJs’ E that she was authorized to practice medicine. Analysis The following is a summary of the ALJs’ determinations: 157.001, Respondent was not responsible for the professional conduct of Dr. Gregory Burzynski and Dr. Marquis in diagnosing and treating patients at the Clinic. Both physicians were qualified by training, experience, and licensure to practice medicine. The evidence presented was insufficient to show that Respondent improperly delegated to either physician medical acts that they were unqualified to perform as set out in Code § 164.053(a)(8) and (9). 1. Under Code § Respondent supervised and delegated medical acts to RAs Rakhrnanov, Tikhomirova, and Acelar and permitt them to be misrepresented to the public as a person authorized to practice medicine in violation of Code § 157.001. By failing to adequately supervise these research associates so that they did not make 2. SOAH DOCKET NO. 503-14-1342.MD PAGE 93 PROPOSAL FOR DECISION such misrepresentations, Respondent also engaged in unprofessional conduct as described in Code § 164.053(a)(8). insufficient to establish that RAs Rakhmanov, Kahn, Tikhomirova, and DeLeon engaged in the practice of medicine or that Respondent delegated medical acts to them that they were unqualified to perform. Therefore, Respondent did not aid and abet these research associates in the unlicensed practice of medicine as defined in §§ l64.052(a)(17), and did not engage in unprofessional conduct as defined by Code § 164.053(a)(9). The evidence 3. is RA 4. Respondent allowed Acelar to engage in the practice of medicine and therefore aided and abetted her in the unlicensed practice of medicine as defined in §§ 164.052(a)(l7), and engaged in unprofessional conduct as defined by Code § 164.053(a)(9). VI. INFORMED CONSENT431 Staff asserts that Respondent failed to meet the standard of care by inadequately informing Patients A through G about: (1) the efficacy and safety of combining various anti— cancer drugs; (2) the reasonably foreseeable side effects of such treatment; and (3) the off-label In general, Staff argues that the Clinic’s informed consent forms did not use of the drugs. provide patients with enough information to clearly inform them about the potential dangers and the “untested, experimental” nature of Respondent’s recommended treatments.432 Staff also alleges that Respondent failed to timely secure informed consents from patients and failed to Staff, comply with the requirements of Board Rule 200.3(2) and According to Respondent’s failure to obtain valid informed consents from these patients constitutes a medicine in an acceptable manner consistent with public health and welfare failure to practice and subjects him that (7)(c). by to disciplinary action pursuant to failing to: Code § 164.051(a)(6). Staff further asserts (1) adequately disclose reasonably foreseeable side effects related to the combined used of drugs; (2) obtain informed consent before treatment; (3) disclose alternative treatments; and (4) appropriately delegate the responsibility of reviewing the informed consent 43] Issues regarding Staff’s allegations that Respondent failed to disclose to patients his ownership interest in other businesses that were associated with the Clinic are discussed in the next section of the proposal for decision and will not be discussed here. 432 Staff’s Closing consents, the ALJs Argument at 66. Although Staff accuses Respondent of giving Patient are aware that Patient elected not to be treated by the Clinic. D D inadequate informed SOAH DOCKET NO. 503-14-1342.MD with Patients described in and PAGE 94 PROPOSAL FOR DECISION A through G to research associates, Respondent committed prohibited practices as Code §§ 164.052(a)(5) and 164.053(a)(8), and 22 TAC § 190.8(1)(A), (C), (G), (H), (1)433 As discussed in the previous section, unnecessary for a physician to review the it is informed consent forms with a patient so long as a qualified person does so. Respondent had the research associates, unlicensed foreign-trained doctors, review the informed consent forms with the patients. Although Staff questions whether the research associates so, as show by a preponderance of the evidence discussed in the preceding section, Staff failed to the Clinic’s research associates were qualified to do were unqualified to that review the informed consent forms with patients. Similarly, the informed consent forms for Afinitor and Sutent signed by Patient E—that misrepresented that Afinitor would only be given if the treatment with Sutent failed—~were previously discussed in Section IV(F)(3), and will not be further discussed here. A. Concurrent Use of Medications The Clinic gave each patient an informed consent statement for the patient’s pretreatment evaluation as well as an informed consent statement for each prescribed drug.434 The pretreatment evaluation informed consent form disclosed that before a specific treatment recommendation and plan could be developed, the patient had to undergo a physical examination, provide a blood and urine sample, and that additional x-rays and scans might be necessary. The form provided a signature line for the “Physician performing consent, paragraph entitled “Patient’s Statement.” following: 433 Staff’s Closing 434 For example, Staff Ex. 5.05.A 435 StaffEx. 5.05.A Argument at 22. at 1799. at 1798-99. This paragraph stated, among 39435 and a other things, the SOAH DOCKET NO. 503-14—1342.MD PAGE 95 PROPOSAL FOR DECISION any specific treatment plan proposed will be discussed with me further and that I [the patient] will be required to sign a more specific informed consent form for the specific treatment [sic] program that I might participate in. I understand that I may freely withdraw from being part of this regimen at any time. I have received a copy of this consent form to keep for myself.436 . . . After a treatment plan was developed, the Clinic gave the patient a separate informed consent form for each drug being administered under the treatment plan. The informed consent form for each drug SIDE EFFECTS listed the potential side effects AND of that drug in a section entitled RISK OF THIS PROGRAM.”437 It “POSSIBLE did not address the effects of the concurrent use of the medications. The informed consent form also advised the patient that “all treatment for your malignancies, either conventional or experimental, have potential side effects, including those that may be life threatening; you should be aware that there are risks associated with this regimen,” and that “this regimen might involve risks of which we are not currently 35438 aware Patient F acknowledged that he signed the informed consent forms regarding the medications in his treatment plan, but said he did not understand what medications he was Although taking. RA Tikhomirova reviewed the informed consent information with Patient F, he admitted that he did not take the time to read the forms.439 Patient F’s wife explained that they felt hurried when they were going over the informed consent forms and what medications Patient F had been prescribed until they met with home.440 Patient F’s wife agreed that there were lengthy discussions effects their local oncologist at at the Clinic 43" For example, StaffExs. 5.03,A ‘37 StaffEx. 5.05A 43“ StaffEx. 5.05.A at 1787. 44" 4‘“ Tr. Vol.4 at at at 918-919; 5.01.A at 312-313; 5.05.A 1787. 173-185; Staff Ex. 6.01.A at 1963-1982. Staff Ex. 66.2 at 36, 104; Tr. v61. 4 (Confidential) at 239-240, 256. Tr. about the side of the medications, and that neither she nor her husband asked any questions to which they did not receive an answer.441 4” did not understand Vol.4 (Confidential) at 258. at 1798-1799. SOAH DOCKET NO. 503-14-1342.MD PAGE 96 PROPOSAL FOR DECISION Staff maintains that Respondent failed to obtain adequate informed consents patients because he failed to disclose the risks associated with Based on the information Staff provided drugs. Respondent Patients meet failed to his ethical from these combining various anti—cancer to him, Staff’s expert, Dr. Fost, testified that and professional responsibility to candidly disclose to A through F the known risks of the drugs being prescribed in their treatment regimen and the potential side effects from combining these drugs in an untested manner.442 Dr. Fost acknowledged that before his retirement, his medical practice focused on pediatrics and bioethics, that he is not an oncologist or a biochemist, and that he did not treat cancer patients. Although Dr. Fost has not been an IRB member for frequently serves as a consultant in the care of cancer patients, 99444 10 years,443 he stated that he and has served on two FDA committees. Dr. Fost agreed that he has never been a principal investigator in an FDA-approved clinical trial.445 Dr. Fost pointed out that the Clinic’s pretreatment evaluation statement represented that the patient would “be asked to sign a treatment specific consent form indicating that [he] understands that particular treatment and that [he] wished to receive that treatment regimen.”446 However, Dr. Fost noted these patients a that after the treatment plan was more specific informed consent regarding were given consent forms Instead, patients established, Respondent did not give the treatment plan to review and sign. for individual drugs without disclosing the risks associated with the patients’ particular treatment plan. Respondent maintains that the Clinic’s informed consent forms speak broadly to the treatment plan and regimen, including that the regimen may be life-threatening.447 In addition, Respondent submits that the Board rules do not require that informed consent forms account 4‘2 StaffEx. 68.01 4‘” Tr. Vol. 1 at 100, 189. 44“ Tr. Vol. 1 at 100. 445 Tr. Vol. 1 at 112. 446 For example, StaffExs. 5.03.A 447 StaffEx. 5.02.A at 24, 30, at 823. at 918-919; 5.01.A at 312-313; 5.04.A at 1229-1230. for SOAH DOCKET NO. 503-14-1342.MD all PAGE 97 PROPOSAL FOR DECISION possible combinations of drugs/agents that may be given a patient. Dr. Levin testified that, in private practice, physicians frequently prescribe medications concurrently without specific consent to the combinations, for instance, blood pressure and cholesterol medications.448 In his opinion, the Clinic’s informed consent forms were sufficient in a private practice setting to counsel the advanced cancer patients about the benefits of each medication, the possible side effects, and the rationale for the use of each drug. In Dr. Levin’s experience, a medical oncologist will tell the patient about the individual drugs, the side effects, benefits, and rationale for administering the drug, but not impart the side effects of the concurrent use of the drugs because they are unknown.449 Dr. Levin explained: Personalized medicine is still a relatively new model although it is now with advanced cancer patients completely accepted in the medical community a physician has to weigh carefully how much information should be provided to a patient. Moreover, in my experience, most patients who have chosen personalized multi-agent therapy know that their prognosis is very poor and have decided to employ a regimen that would probably not be given in an academic To provide such information institution or in most general oncology practices. is simply not the standard of care used by private practitioners employing this treatment approach.450 . . . When explained, . . . an adult cancer patient has no other curative treatment options, Dr. Levin it is a physician’s duty to consult with the patient and arrive treatment based, in part, on the physician’s prior experience.”45 trials, it is more common than target agents is evidenced by published and anti-cancer drugs to treat Resp. Ex. 165 at 56. “49 Resp. Ex. 165 at 36. 45° Resp. Ex. 165 at36. 451 Resp. Ex. 165 at 32. ‘52 Resp. Ex. 165 at 34. He noted that outside of clinical articles that oncologists use multiple- advanced cancer patients where the use of the drugs based primarily on the physician’s prior experience.452 44“ 1 at “the best possible is PAGE 98 PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14-1342.MD Dr. Levin emphasized that the Clinic’s consent forms disclosed that the treatment regimen may be aware.”453 The “life-threatening” it “might involve risks of which Clinic’s medical records, Dr. Levin reported, one drug and monitored for side Dr. and that Wetmore, agreed effects before showed are not currently that patients adding another drug.454 that the Clinic provided every patient we Even were given Staff’s expert, an informed consent form for each drug prescribed that advised the patient that the drug could have life-threatening side Additionally, Dr. Levin pointed out that the toxicities and side effects of effects.455 combined anti— cancer drugs are not widely published and are frequently unknown. In his opinion, a physician may explain the benefits and rationale for treatment with concurrent use of drugs, but it would be impossible for the physician to impart unknown side effects from this combination.456 Because the risks of the concurrent use of anti-cancer drugs are unpredictable, he maintained that physicians are not required to provide a specific informed consent form to the patients about such risks.457 SuCh a requirement, he The ALJs find that they that would be asked insisted, is beyond the standard of care.458 having represented to patients on the preevaluation informed consent later to sign a treatment-specific consent form for the specific treatment program, Respondent was obligated to ensure the Clinic provided such an informed consent to the patients. The record reflects Violation of 22 TAC § that Respondent failed to do so for Patients A through G in 190.8(1)(I). However, the credible evidence established that in a private practice setting, the informed consent statements given to the Clinic patients for each drug included in their treatment plan was sufficient to provide the patients with adequate information about the drug to give an informed consent for the drug. Dr. Levin’s testimony that the concurrent use of various anti-cancer drugs 453 For example, Staff Ex. 5.2.A. 4 4 Resp. BX. 165 at35-36. L1. 455 Tr. Vol.3 at 121, 124, at 125-126. 456 Resp. BX. 165 at 36. 4 u: 7 Resp. BX. 165 at35-37. 458 Respondent’s Brief at 33. 822—823. SOAH DOCKET NO. 503-14—1342.MD is frequently unknown and based PAGE 99 PROPOSAL FOR DECISION in part on the physician’s experience in using the drugs was compelling. The informed consent forms indicated that use of the drugs could be life-threatening regimen were unknown. Therefore, the ALJS and that the risks associated with the treatment find insufficient evidence to support Staff’s allegation that Respondent informed consent as to each combination of anti-cancer drugs used to was required to obtain an treat an advanced cancer patient. Timeliness of Obtaining Informed Consent B. Staff asserts that Patients A, B, C, E, and F were treated with anti—cancer drugs before Respondent had the patients review and sign the informed consent forms in violation of Board Rule 190.8(1)(I).459 Untimely consent, Staff submits, must be obtained “prior to the initiation most of the informed consent forms provide details on 2011, Patient taking this drug the same day.461 Irinotecan4 for September 2, of the treatment plan.”460 In addition, Staff contends that for these patients did not identify the physician in charge or how the informed consent was obtained. On August 30, form 62 A signed the informed consent form for Afinitor and began On September 1, 22 TAC performing 2011, Patient and began treatment with 2011, Patient A this A signed the informed consent drug the same signed the informed consent form for Votrient treatment with this drug on September 6, 2011.465 459 inadequate because informed consent is Patient A day.463 464 On and began signed the informed consent for § 190.8(1)(I) states that a physician’s failure to obtain from a patient an informed consent before treatment, or procedures, constitutes engaging in a practice inconsistent with public health and tests, welfare. 46° 33 Staff Exs. 5.02.A at 814, 838 (Patient A); 5.03.A at 912, 1135 (Patient B); 5.05.A at 1618, 1797 (Patient E); at 22637. 46‘ StaffEx. 5.02.A 462 StaffEx. 5.02.A at 825-828. 463 Staff Ex. 5.02.A at 799. 46“ Staff Ex. 5.02.A at 822-824. “5 at 799, 829-831. Staff Ex. 5.02.A at 796. PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Avastin on October 14, 2010,466 and began treatment on October 15, 2010.467 Patient the informed consent for PB468 2010.469 The ALJ S find on October that the consent 11, 100 A signed 2010 and began PB treatments on October forms were reviewed and signed by Patient 11, A before receiving treatment with the drugs. On February treatment with it the 8, 2011, Patient B signed the informed consent form for same day. On February 9, informed consent form for Avastin was not signed 2011, Patient administered. B 471 B was 2011, Patient until PB and began given Avastin, but the February 17, 2011.470 On February 15, signed an informed consent form for Votrient, the day the drug was first On July 5, 2011, Patient day the drug was first administered. 472 B signed an informed consent form for Tarceva, the On July 6, 2011, Patient form for Afinitor, the day the drug was first administered. 473 B signed an informed consent On July 7, 2011, Patient B signed informed consent forms for Sprycel and Nexavar, the day the drugs were first administered.474 With the exception of the February 9, 2011 consent form for Avastin, the ALJs find informed consent forms were reviewed and signed by Patient B that the before receiving treatment with the drugs. On May 14, 2010, Patient C signed the informed consent form and then began treatment with PB.475 On May 17, 2010, Patient C signed the informed consent form and then began treatment with Avastin.476 On May 18, 2010, Patient C signed the informed consent form and “6 StaffEx. 5.02.A 467 4“ “9 at 832-834. StaffEx. 5.02.A at 808. StaffEx. 5.02.A at 836-838. StaffEx. 5.02.A at836-838, 814. 47° Staff Ex. 5.03.A at 909-911, 1020. 47‘ Staff Ex. 5.03.A at 912-914, 1024. 472 Staff Ex. 5.03.A at 906-908, 1049. 473 Staff Ex. 5.03.A at 903-905, 1050. 47“ Staff Ex. 5.03.A at 897-902, 1051. 475 Staff Ex. 5.04.A at 1226-1228, 1439. 476 Staff Ex. 5.04.A at 1222-1224, 1438. SOAH DOCKET NO. 503-14-1342.MD PAGE 101 PROPOSAL FOR DECISION then began treatment with Tarceva.477 On May 19, 2010, Patient form and then began treatment with Nexavar. Patient C C signed the informed consent signed the informed consent for each drug prior to receiving treatment with that drug.478 After Patient C was discharged from the Clinic and returned home to Indiana, he continued the cancer treatment under the care of his local oncologist, Dr. Waits. maintains that it was Dr. Waits’s Respondent responsibility to secure informed consent for any new drugs administered to the patient while the patient was in Dr. Waits’s care. Staff provided no authority to address such a situation. Because Dr. Waits was caring for the patient and administering the new drug, the ALJS find once Patient that C returned home and was being treated by Dr. Waits, any additional informed consent forms that the patient needed to review and sign were his responsibility. The ALJS find reviewed and signed by Patient On September that the consent C before receiving treatment with the drugs. 2011, Patient 8, began treatment the same forms for drugs the Clinic administered were day.479 E signed the informed consent form for On September 9, PB and then 2011, he signed the informed consent form and then began treatment with XgeVa (denosumab).480 Patient E signed the informed consent for Afinitor on September On September started 13, 15, 2011. 14, 2011.482 reviewed them with the signed by Patient 477 2009, the same day he began treatment with this drug.481 2011, Dr. Yi also prescribed Sutent to Patient E, indicating that on September September 14, RA at 1216-1218, 1436. 47? Staff Ex. 5.05.A at 1648, 1795-1797. 48° Staff Ex. 5.05.A at 1646, 1792-1794. 4‘” Staff Ex. 5.05.A at 1645, 1789-1791. 4” 483 StaffEx. 5.05.A at 1641, 1786-1788. Staff Ex. 5.05.A at 1632, 1786-1788. to be these consent forms and represented that she The ALJS find that the consent E before receiving treatment with the drugs. StaffEx. 5.04.A at 1219-1221, 1437. "8 StaffEx. 5.04.A was PatientE signed the informed consent form for Sutent on DeLeon signed patient.483 it forms were reviewed and SOAH DOCKET NO. 503-14-1342.MD Patient on October October 14, F began treatment with PB on October 10; Zolinza on October 9, 11, 9, 102 2009; Rapamune with grapefruit juice 2009 and Xeloda on October On 13, 2009. 2009, he began receiving Avastin, with Nexavar scheduled to begin the next day. The informed consent forms October PAGE PROPOSAL FOR DECISION for PB, Rapamune, and Zolinza were signed by Patient F on 2009, before he received treatment. The informed consent form Xeloda was for signed October 13, 2009, and the informed consent forms for Avastin and Nexavar were signed on October the 15, 2009.484 ALJs find With the exception of the October that the consent 15, 2009 consent form for Avastin, forms were reviewed and signed by Patient F before receiving treatment with the drugs. Based on the record, the ALJs find consent from Patients B that Respondent did not timely obtain informed and F before beginning treatment with Avastin, in violation of Board Rule 190.8(1)(I). Off-label Use of FDA-Approved C. Drugs Staff maintains that the informed consent forms signed by Patients A, B, C, E, and failed to document that the drug was being prescribed F off-label or that Respondent’s treatment plan involved a drug treatment that could be “fatal.” Instead, Respondent’s informed consent forms advised the patient that the drug could be “life-threatening.”485 Dr. Levin testified 2005, that, in NCCN reported that approximately 50-75% of anti-cancer drugs used in treating cancer in the United States were used off-label.486 Drs. Burzynski and Levin disagree with Staff’s allegation that Respondent to include label,” on the informed consent form meaning that the FDA had not approved the medications Respondent. Dr. Burzynski pointed out 48“ Staff Ex. 6.01.A at 2047-2049; 2066; 2071. 485 Staffs Closing Argument 4“ Resp. BX. 165 at 11, at 54. that the drugs being prescribed that, was required were being used “off- for the use intended by although the Clinic’s informed consent forms did SOAH DOCKET NO. 503-14-1342.MD PAGE 103 PROPOSAL FOR DECISION not identify that the drugs were being prescribed “off—label,” the forms did disclose for what uses the FDA Dr. Burzynski also stressed that the patients were had approved the medication. informed that the drugs were being prescribed “off-label.”487 The ALJs find that Staff provided insufficient evidence the Code or any Board rule rather than stating that he to show that Respondent what uses had FDA approval Board Rule 200.3(2) and (7)(C) required Respondent to disclose to by identifying in the informed consents was using the drug “off-label.” Alternative Therapy or Clinical Trials D. According to Staff, 488 any patient receiving alternative therapy the objectives of the treatment; the extent to which the proposed treatment could interfere the, risks for human acknowledged use; and that the treatment that the patients receiving FDA ANP, was under and benefits; with any ongoing or recommended medical care; the underlying therapeutic basis for the treatment; whether the it violated FDA had approved clinical investigation if it was. Staff had oversight of the informed consent forms the Clinic used but argued that the FDA’s correspondence for indicated that the Clinic’s consent forms did not comply with federal regulations.489 Staff also asserts that Respondent failed to secure informed consent from Patient ANP. However, with ANP in the evidence previously discussed Germany. Patient Patient G’s informed consent 4‘” B did not receive showed ANP was inadequate because it that Dr. B for Brandt treated Patient at the Clinic.490 According to B Staff, did not disclose the patient’s financial Tr. Vol. 7 at 152. TAC 488 Complementary and alternative medicine is defined in 22 § 200.2(1) as “[t]hose health care methods of diagnosis, treatment, or interventions that are not acknowledged to be conventional but that may be offered by some licensed physicians in addition to, or as an alternative to, conventional medicine, and that provide a reasonable potential for therapeutic gain in a patient’s medical condition and that are not reasonably outweighed by the risk of such methods.” Conventional medicine is defined as “[t]hose health care methods of diagnosis, treatment, or interventions that are offered by most licensed physicians as generally accepted methods of routine practice, based upon medical training, experience and review of the peer reviewed scientific literature.” 22 § 200.2(2). TAC 489 Staff referred to its discussion in Section VII.l of its reply brief regarding Dr. Burzynski’s ethical responsibilities a clinical trial. Staff’s Reply to Respondent’s Closing Argument at 13. when conducting 490 See Section IV.C. SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION responsibilities for all costs except for the ANP and did not disclose Respondent’s 104 interest in These issues are addressed ownership in other businesses associated with the Clinic. in subsequent sections and will not be addressed here.491 The ALJs find that the FDA and Respondent ultimately reached a resolution regarding the contents of the informed consent forms to be used in a clinical study. Therefore, the find that this issue FDA. In addition, the violation of the E. was remedied through the proper process FDA’s correspondence Code or the Board rules without Summary of ALJs’ welfare. Patients among Respondent, BRI, and the regarding the consent forms does not establish a further evidence of such a Violation. Analysis Board Rule 190.8(1)(I) provides “before performing ALJs tests, treatments, that the failure to obtain or procedures,” is informed consent from a patient inconsistent with public health and A through F were not involved in the Clinic’s clinical trials, but because the treatments that were provided to them constituted “complementary and alternative medicine” as defined by Board Rule 200.3, this rule is also applicable to these patients. v Respondent allowed the Clinic to misrepresent in the patients’ preevaluation informed consent form that the patient would be asked to sign a treatment specific consent form for the specific treatment program when no such informed consent was provided to patients. Such conduct violated 22 TAC § l90.8(l)(l). 1. Respondent failed to give Patients B and F the informed consent forms for Avastin before administering the drug to the patients in Violation of 22 TAC §§ l90.8(l)(G), (H) and (I) and 2. 200.3(2). 491 The issue concerning Respondent’s responsibility to disclose his financial interest in associated businesses is addressed in the next section of this PFD. The issue concerning Respondent’s alleged failure to disclose Patient G’s financial obligations while being treated with ANP is addressed in Section X.G. SOAH DOCKET NO. 503-14—1342.MD VII. PAGE 105 PROPOSAL FOR DECISION DISCLOSURE OF OWNERSHIP INTEREST IN PHARMACY AND LABORATORY Staff alleged that the failure of Respondent to disclose his ownership interest in the pharmacies that dispensed the drugs prescribed to Clinic patients and his ownership interest in the laboratory that performed the tests ordered for Clinic patients constituted unprofessional conduct. Board Rule 190.8(2)(H) provides that a healthcare provider facility, laboratory, or who pharmacy without disclosing the existence of the interest in the entity to that patient has engaged in unprofessional refers a patient to a licensee’s ownership conduct that is likely to deceive, defraud, or injure the public. Respondent who is the sole owner of Southern Family Pharmacy and SRB Pharmacy. received care from Respondent had their medication prescriptions, including filled at Southern Family Pharmacy or Patients PB and ANP, SRB Pharmacy.492 The SR Burzynski Lab, also owned by Respondent, conducted laboratory analysis of samples taken for patients treated by Respondent and Respondent’s subordinates. 493 Staff argues that Respondent and others at the Clinic did not disclose Respondent’s ownership interests in the had no understanding interest in the he had a legal or ethical responsibility to disclose his ownership pharmacies to patients seen was located within stated that that pharmacies or laboratory to patients. Dr. Burzynski testified that he at the Clinic the Clinic building, but that he even though Southern Family Pharmacy would explain his ownership if asked. this assumption. He in the initial Staff Complaint, a notice was he had relied on the legal advice of his long-time attorney in further stated that after the matter was brought up He posted at the pharmacy that Respondent was the owner.494 Patient F testified that the financial officer at the clinic told his prescriptions, 4” 4” 49“ 4” and the only place they could get PB, was owned by Respondent.495 Tr.Vo1.9 at 127-129. Vol.9 at 131-132. Tr. Tr. Vol. 8 at 111. Tr. Vol.4 at wife and him that the pharmacy where they could get the 115-116. PAGE 106 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD In his deposition, Dr. Gregory Burzynski stated he was not sure if he disclosed A through G, but he may have, and Respondent’s ownership interest in the pharmacy to Patients he thought the patients understood that his father was the owner.496 In his deposition, Dr. Marquis stated that, for the patients he saw, he never disclosed Respondent’s ownership interest in the pharmacy.497 Dr. Burzynski testified that he did not disclose his ownership interest in the lab because the name SR Burzynski Lab was on every lab report. disclose his ownership interest because there knew the lab’s name Staff asserts that this after they lab results bearing the name of would have accrued charges in it or in as the Clinic, it is the lab until after the tests were for the laboratory tests. Pharmacy was located to the Clinic patients. Respondent’s failure to disclose his ownership interest in the only pharmacies where the patients could get TAC § interest in were directed to have laboratory by SR Burzynski Lab. it. it is clear StaffEx, 497 StaffEx. 66.11 at 49* Tr. Vo1. 9 at 132—133. 499 SR Burzynski Lab In addition, Staff has pointed to tests prior to As a result, from the name or ANP was a that no evidence Respondent that patients being informed that the tests were to be performed Staff has failed to establish that Respondent failed to disclose his ownership interest in the laboratory, in violation of 22 496 PB 190.8(2)(H). In regard to the laboratory, had some ownership in the apparent that no specific disclosure of Respondent’s ownership SRB Pharmacy was made violation of 22 not adequate to In addition, Staff argues that patients In regard to the pharmacies, even though Southern Family same building is nothing in the records to indicate that patients prior to the tests’ being conducted. would not have seen the conducted and is 498 TAC § 190.8(2)(H).499 66.GG at 8-9. 6. argued that Respondent failed to disclose his ownership interest in Ampolgen, a company that markets and distributes a generic version of PB tablets, and in BRI. However these issues were not included in the pleading and therefore cannot be addressed in this proposal for decision. In its Briefs, Staff also owned by Respondent SOAH DOCKET NO. 503-14-1342.MD PAGE 107 PROPOSAL FOR DECISION IMPROPER CHARGES AND RETAINER DEMANDS VIII. Staff alleges that Respondent and other persons under Respondent’s direction, supervision, and control participated in misleading patients into paying retainers prior to receiving evaluation and treatment, billing patients for exorbitant charges for drugs, medical supplies and medical services, and charging for drugs, medical supplies and medical services that were not medically necessary and national average and the A charges to Patients violations of Code § if the act is recommended cap through G, as (1) testified were often several times the for services.500 listed on Appendix § 164.053(a) that authorizes the Respondent based on law Wetmore that Dr. Board According B to Staff, these improper of the Complaint, constituted to take disciplinary action against Respondent’s commission of an act that violates any state or federal connected with the physician’s practice of medicine;501 and/or (2) in violation of 311.0025(7) of the Texas Health and Safety Code502 that prohibits a hospital, treatment mental health payor, a facility, bill for or health-care professional from submitting to a patient or a third party a treatment that the hospital, knows was improper, unreasonable, facility, or professional which knows was not provided or or medically or clinically unnecessary.503 In addition, Staff alleges that these actions constituted violations under § 190.8(2)(J), facility, states that providing medically Code § 164.052(a)(5) and 22 TAC unnecessary services to a patient constitutes unprofessional and dishonorable conduct. Staffs expert Elaine Kloos, maintained that Respondent, as the president and owner of the Clinic, was responsible charged Patients for the Clinic’s billings.504 In her opinion, Respondent improperly A through G and third-party payors for: medically unnecessary diagnostic testing, drugs, treatments other than drugs, medical supplies, and medical services; 50 500 Staff Exs. 61.A.01 at 45074, 45079, 45081, 45085, 45088, 45091, 45094; 68.03 at 22-23, 31-32, 36, 46, 49-50, 56, 61-62, 67, 69-70, 90. 5‘” Code 502 Code§ 503 Tex. Health 5"“ StaffEx. 68.02 at § l64.053(a)(1). 164.053(a)(7). & Safety Code § 311.0025(a). 7, 9, 14, 16-17, 75-76, 80-102. SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 108 prolonged services, after-hours visits, diagnostic testing, drugs, treatments other than drugs, medical supplies and medical services that were inadequately supported by documentation in the medical record; office visits, education, and telephone contacts as though a physician’s services were provided when the services were rendered by non-licensed foreign medical graduates or nursing staff; “monthly case management fees,” as though the patients were under the care of a home health agency when they were not; and weeks of near-daily infusions of ANP to Patient G as though the drugs were being administered by clinic staff when ANP was administered the drugs at home by the patient or her caregivers. six Additionally, Ms. Kloos pointed out that Respondent opted out of Medicare, but failed to provide adequate opt-out notices to the Clinic patients.506 Respondent disputes that the Clinic improperly charged any that the following charges PB patient. were reasonable and medically appropriate: Respondent argues (1) patient treatment with based on Dr. Burzynski’s experience and knowledge; (2) the monthly case management fees based on the ongoing management by Clinic staff of patients who returned home and were under the primary care of their local physicians; (3) medical testing and other services; and (4) visits or consultations with the Clinic’s physicians and other medical staff. that charging a retainer before providing services is not prohibited the patients who paid for services Respondent argues Respondent further maintains by statute or Board and actually received them. that Staff’s allegations concerning “fraudulent” billing coding overlooked that Patients rules, and inaccurate A through F were private pay patients and were not covered by insurance or Medicare. (Patient’s G’s treatment was partially covered by insurance.) After their initial visit to services. the Clinic, Respondent asserts, these patients (except Patient Such private pay patients, as the Clinic’s billing D) paid a flat rate manager Leann Chiapetta explained, 505 Ms. Kloos admitted that she was not qualified to give an opinion on the standard of care. 5’06 StaffExs. 61.C.01 at 45201-45202; 68.02 at 14-18, 98-99, 103. for Tr. Vol. 2 at 17. were often billed “flat companies, the bills are . . . instead of billing the codes out,” while for all broken down into codes for supplies, monitoring, Danuta Wojciechowski, the Clinic’s coder, explained counselor’s job to explain the monthly in addition to supplying PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD management that, some insurance etc.507 although fee, the services it was the financial covered by the fee included, to face [visits], monitoring, [and] follow PB, “face 109 Sadie Ratliff, a Clinic financial counselor, testified that the monthly up visit[s].”508 management fee, as described in the Treatment Billing Agreement signed by each patient,509 covered a variety of services, including: intensive patient monitoring, physician supervision and management of patient care. Telephone conferences with the patient, family, and/or other healthcare providers, analysis of data, integration of new information into the revised treatment programs, per patient tolerance, compilation of dictated medical report, laboratory findings, progress notes, and other data in order to maintain maximum patient care and medical supplies for the pump and catheter follow—up Visits, care.510 Respondent points out coding and medical that Ms. Kloos agreed a billing, there is from fee-for-service towards flat fee movement rates, due to the growing complexity of CPT that, in a part but that this of the medical industry to movement is slow—moving move away in the practice of oncology.511 In addition, Respondent pointed out that the private Clinic patients agreed from the beginning that they would be responsible Ms. Kloos conceded that Patients fee billing for certain services.513 5°7 Staff Ex. 66.Y at 27-28. 5 C8 StaffEx. 66.8 at 24-25. 509 See 5 ° StaffEx. 66.1 .d 5“ “2 “3 Tr. See Tr. e.g., StaffEx. 7.06M at 3522. at 18. Vol.2 at30-33. e. g., StaffEx. 7.06.M at 3524. Vol.2 at 34-40. if insurance did not cover their treatment.512 A, E, and F’s billing agreements were examples of flat Respondent argues that, because coding was not a basis for PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD 110 charging these patients and, as testified to by Ms. Chiapetta, was not used in billing some insurance payors, any inaccurate coding was immaterial. Ms. Kloos acknowledged in her career, only that of the approximately 80 oncology practices she has audited one was correctly billing.51 4 She explained that increased in complexity in the past 10 to 15 years, and the use of the She acknowledged mistake.515 that there and coding had wrong code was a common was an extreme shortage of people who were capable of what she believed to be proper coding and billing in the oncology Ms. Kloos billing stated that the Clinic’s director of setting.516 finance administration “should be responsible for the integrity of proper coding and billing,” and that Ms. Chiapetta, as the billing would be the person responsible supervisor, for making sure the coders and the physicians at the Clinic was involved in billing, and that he only reviewed a make any grade. Ms. Kloos acknowledged that at effort to get involved in billing one hospital she worked because doing so was “a bill if there for, the little bit C00 was a did not beneath his pay ”519 Respondent argues that although Ms. Kloos opined that in the were Dr. Burzynski testified that neither he nor any of the properly performing their duties.517 complaint.518 billers medical records, it cannot be bille d,520 she if something is not documented did not investigate in this case beyond what medical records were provided to her. She never spoke with a patient, any of the physicians, or anyone working were required 5” 5” at the Clinic.521 to properly Tr. Vol.2 at 21; StaffEx. 66.FF Staff Ex. 66.FF at 39-40. 5” StaffEx. 68.03 at 10. 5‘9 52" 52‘ their Tr. v61. 2 at 13-14. 516 5‘8 keep Ms. Kloos StaffEx. 7 at 78. Tr. Vol.2 6:21-22. Tr. Vol.2 at 65, 68-69. Tr. Vol.2 at 17-18. at 26. stated that, in general, the oncologists at the Clinic medical records; that Respondent, as the owner of the Clinic, was responsible for the accuracy of the medical records; Office of the Inspector General, the PAGE 111 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD and that, according CEO is responsible for the integrity of his practice In reply, Staff asserts that the billing records for Patients C, F, and party payors and that the to the federal Board Rule 190.8(2)(J) requires G were sent to third that proper billing statements be submitted to patients and/or third party payors, meaning that the billing statement must not be misrepresenting the services provided, or otherwise failing to meet professional false, fraudulent, standards. As for the argument that Respondent billed flat Jasmine Spotswood, the backup into a predetermined set codes set forth) fees, Staff points to the biller at the Clinic, that the of codes derived from a super charges were bill (a initially testimony of broken down piece of paper with services and and then compared with the notes dictated by the physician into the medical records for each patient.522 A. Patient A Billings 1. A for PB and monthly case management; a Lipid Panel test; a measurement of blood oxygen level; a CA 19—9 In Appendix Cancer Antigen test; B to its Complaint, Staff asserts that the charges to Patient and an office visit on August 29, 2011, with Dr. Marquis were improper, unreasonable, or medically or clinically unnecessary. 2011 charge for measurement of blood oxygen level is Of these cited by Ms. Kloos not being supported by documentation in the medical records. stated in her report that she did not include bills as being properly documented in the medical records. 5” StaffEx. 66.P 5” confirmed cancer at 10-14; diagnosis, StaffEx. 5.02.A StaffEx. 61.03.C at 45185-45187. at It in her expert report as should be noted that Ms. Kloos improper for which the CPT code was 523 In her expert report, Ms. Kloos noted that Patient pathologically charges, only the August 30, A presented to the Clinic without a which apparently was the basis 712-716. for her opinion that PAGE 112 SOAH DOCKET NO. 503—14-1342.MD PROPOSAL FOR DECISION none of the Clinic charges were reasonable.524 Patient A’s wife testified Patient for his treatment A had cancer when he presented at the Clinic.525 Patient A filled out a client information sheet indicating he had been diagnosed with colon cancer.526 Records from the Clinic recommended physicians Patient that the patient have a biopsy.527 that Patient show A’s wife testified A had already had one biopsy and was not interested in another, and that the that his doctors in North Carolina did not want him to have to go through that again.528 The record establishes that there support the Clinic’s treatment of Patient As plan for for the charges for PB was sufficient documentation A for cancer. PB, Ms. Kloos stated in her expert report that the administration dated October 11, 2010, was not signed by a physician.529 Ms. Kloos also testified that the Clinic had no documentation in Patient A’s medical records explaining the rationale and medical necessity for the prescribing of PB.530 This opinion allegation that the charges to Patient The notes from is the October 10, 2011 oncology assessment signed Patient A’s treatment plan which Respondent argues the informed consent apparently the basis for Staff’s A for PB were not supported by the medical records. on Respondent’s recommendation, Patient indicate that, based that its in the medical records to lists is all form for the amount, frequency, that is required PB by the signed by Patient A would number of A on October start refills, rule.532 In addition, by Dr. Valladares receiving PB.531 and dosage of PB, Respondent points 11, 2010. That form to states purpose was to “alleviate the symptoms and decrease the size of your tumor and to 52“ StaffEx. 61.03.C 525 Tr. Vol. 5 at 79. 52" StaffEx. 5.02.A 527 Staff Ex. 5.02.A at 729. 52" Tr. Vol. 5 at 82-84. 529 Staff Ex. 61 .03.C at 45176. Staff also cites in its Closing Argument to Ms. Kloos’s prefiled testimony regarding billings for physician consultations and Medicare opt-out that are not included in Staff’s pleadings. 53° StaffEx. 68.02 at 30. 53‘ StaffEx. 5.02.A at 791-792. 532 22 TAC at at 45176. 816. § 165.1(a(6)(A)' SOAH DOCKET NO. 503-14-1342.MD improve your nutritional status.” PAGE PROPOSAL FOR DECISION It acknowledged that PB was “not yet standard,” but had “demonstrated anticancer activity in both laboratory and clinical studies.” informed consent advised Patient phenylbutrate that . . . [there is] A that “tests 113 have revealed anti-tumor In addition, the activity of sodium evidence that phenylbutrate induces death in cancer cells . . . [and PB] may be of benefit to advanced cancer patients.”533 The record establishes that there was sufficient rationale in the medical records for the prescribing of PB to Patient A. Ms. Kloos also testified that Patient A’s medical records did not indicate that he actually PB on October 11 through 14, 2010.534 Respondent points out that the Clinic’s nursing listed PB as a medication given to Patient A on October 11 through 14, 2010,535 and a received notes patient checklist, signed and dated October 11, 2010, showed that Patient A had “completed test dose of PB tablet,” and was “given instruction and understands the dosage regimen ordered by the physician.”536 PB The Clinic’s nursing records for October 12 through 15, 2010, also cited the dosage given to Patient A on the previous day, which matched the amount the Clinic billed to the patient.537 This dosage comports with the October 11, grams four times a day and increase until reaching a 2010 treatment plan to start PB at 0.5 three-gram dosage given four times per day.538 The record establishes that Patient A actually received PB on October 11 through 14, 2010. In regard to the allegation that the amount of the charges management were improper or unreasonable, Respondent argues 5” StaffEx. 5.2.A at 836-838. 534 Staff Ex. 68.02 at 22-23. 535 Staff Ex. 5.2.A at 809-812. 536 StaffEx. 5.2.A at 813. 537 StaffEx. 5.2.A at 809-812, 880. 5” StaffEx. 5.2.A at 718. for PB and monthly that, as the billing case statements SOAH DOCKET NO. 503—14-1342.MD ShOW, by the time Patient $240 per day, or $7,200 recommended dosage, A achieved the recommended dosage of PB, the cost would have been per month.539 However, after Patient A reached the treatment plan’s the Clinic stopped charging separately for monthly case management fee billing records, the case PB and rolled the cost into the that started at $4,500 per month.540 by December of 2010, two months management PAGE 114 PROPOSAL FOR DECISION after Patient According to Patient A’s A began treatment, the Clinic cut fee in half.541 Patient A’s wife acknowledged that she understood the case management cost of PB,542 and testified that, at their request, the Clinic reduced the case make the treatment more The record Patient establishes that charges for for the charge Respondent argues error.544 management fee to affordable for her husband.543 A were reasonable. As fee covered the PB and on August 29, 2011, that this was for a the monthly case management fee $200 office actually a visit with Dr. Valladares Although Patient A’s wife initially testified that on her husband on August 29, 2011, she later visit to with Dr. Marquis, and was simply an entry RA Rakhmanov conducted the physical agreed that it could have been performed by Dr. Valladares.545 The office visit charge of August 29, 2011, was supported by the evidence despite the erroneous entry as to which physician was seen. In addition, the rationale for the Lipid Panel test, measurements of blood oxygen in Section IV(B)(2) 5” and (3) above. Staff Ex. 5.2.A at 880. 54° Staff Ex. 5.2.A at 883-890. 5‘“ StaffEx. 5.2.A at 890-892. 5“ StaffEx. 66.T at 543 Tr. Vol. 5 at 75. 54“ StaffEx. 5.02.A “5 56-57. at 770-71, 892. Tr, Vol. 5 at 44; 47-48. level, and CA 19-9 Cancer Antigen test are fully discussed SOAH DOCKET NO. 503-14-1342.MD Summary of ALJ’s Analysis 2. The ALJs find no violations B. Patient 1. PAGE 115 PROPOSAL FOR DECISION as alleged regarding the billings to Patient A. B Billings In Appendix B to its Complaint, Staff asserts that the charges to Patient B were improper, unreasonable, or medically or clinically unnecessary. Specifically, Staff cited the charges from February 7through March 4, 2011, for genetic testing, physician services, office consultations, drugs, office/outpatient visits, blood oxygen level measurements, Lipid Panel tests, medical equipment, health education, nutritional therapy, and the monthly management fees for March through September, 2011. Ms. Kloos testified that the coding was inaccurate and unsupported by for Patient B’s initial office visit the medical records because personally spent 2/: hours with Patient B when it on February 7, 2011, reflected that Dr. Valladares his dictated notes were barely a page long.546 However, the medical records show that other physicians, including in Patient B’s treatment that day. Respondent argues that even though he participated in the initial consultation and recommended the treatment plan that Patient Respondent, were involved B decided to follow rather than the standard radiation treatment recommended by Dr. Valladares, only Dr. Valladares billed the patient for that meeting.547 Respondent points out that Respondent did not bill Patient the time spent reviewing the medical records Patient The charges 545 StaffEx. 68.02 5‘” Staff Ex. 5.03.A at 1060-61. 54“ StaffEx. 5.03.A at 1125-26. at 52:20. for B sent to the Clinic before the meeting.548 for a 21/2 hours initial consultation B were reasonable. B between two Clinic physicians and Patient SOAH DOCKET NO. 503-14-1342.MD The office February visits with a physician were billed B 2011, Patient 8, PAGE 116 PROPOSAL FOR DECISION at $125 for each outpatient visit. On reported to the Clinic and “the team,” including Respondent, B was started on PB. Dr. Gregory Burzynski reviewed 550 On that day, Patient B was and executed the informed consent form for PB with the patient. only charged $125 for a visit with Dr. Valladares.551 On February 9, 2011, the records showed that Patient B reported to the Clinic, where his Vitals were taken, and he was started on Avastin reviewed the patient’s MRIs.549 Patient and Decadron. All side effects of these two drugs were discussed with the patient, 552 and he was given a complete history and physical by Dr. Valladaresm For this he was charged $125 for a visit with Dr. Marquis, which was a clerical On February 10, 2011, Patient Burzynski for which there is results, B was a profile 1 The results iron saturation considered for participation in an charged $125 for a 555 no medical record. the Clinic and had his Vitals taken. based on the error.554 On February 11, It was with Dr. Gregory 2011, Patient of his blood (genetic) was ordered. visit tests B presented at were reviewed and, also noted that he ANP clinical trial.556 Patient B was charged $125 would be for this visit B presented at the Clinic and had his Vitals taken. Dr. Marquis directed that his dressing for the Hickman catheter be changed.558 Patient B was charged $125 for this Visit with Dr. Valladares, which again was a clerical error.559 On with Dr. Valladares.557 On February February 15, 2011, Patient 549 StaffEx. 5.03.A at 1019. 55° StaffEx. 5.03.A at 915-917. 55‘ StaffEx. 5.03.A at1201. 5” StaffEx. 5.03.A at 1020. StaffEx. 5.03.A at 1063-1064. StaffEx. 5.03.A at 1201. StaffEx. 5.03.A at 1202. 556 StaffEx. 5.03.A at 1021. 557 StaffEx. 5.03.A at 1202. 558 Staff Ex. 5.03.A at 1022. 5” 55“ 5” 5” StaffEx. 5.03.A at 1203. B 14, 2011, Patient presented at the Clinic and had his Vitals taken. Dr. Marquis SOAH DOCKET NO. 503-14-1342.MD directed that the administration of Votrient be started.560 visit with Dr. Valladares, which again was a clerical On PAGE 117 PROPOSAL FOR DECISION February 16, 2011, Patient B Patient B was charged $125 for error.561 presented at the Clinic and had his Vitals taken. Dr. Valladares directed that the administration of Avastin be started.562 Patient $125 for this visit with Dr. Valladares.563 this On February 17, 2011, Patient B B was charged presented at the Clinic and had his Vitals taken. Dr. Valladares again directed that the administration of Avastin B was charged $125 for this visit with Dr. Valladares.565 On February 18, 2011, Patient B presented at the Clinic and had his Vitals taken. Dr. Marquis 566 Patient B was charged $125 for this visit with directed that he continue the treatments. Dr. Weaver, which was a clerical error.567 On February 21, 2011, Patient B presented at the be started.564 Patient ' Clinic and had his Vitals taken. Dr. Valladares directed that the Avastin dosage be increased.568 Patient B was On February charged $125 for 22, 2011, Patient this Visit B with Dr. Weaver, which again was a clerical presented at the Clinic and had his Vitals taken, at which visit Dr. Valladares discussed the beginning of the administration of was charged $125 On ANP in Germany.570 February 23, 2011, Patient 56° Staff Ex. 5.03.A at 1024. 56‘ StaffEx. 5.03.A at 1203. 562 StaffEx. 5.03.A at 1025. 5‘” StaffEx. 5.03.A at 1204. 56“ StaffEx. 5.03.A at 1026. 565 StaffEx. 5.03.A at 1205. 567 5“ StaffEx. 5.03.A at 1029. Staff Ex, 5.03.A at 1207. StaffEx. 5.03.A at 1030. 569 Staff Ex. 5.03.A at 1207. 57° Staff Ex. 5.03.A at 1031. 5“ 572 Patient B for this Visit with Dr. Valladares.571 B presented at the Clinic and had his Vitals taken, and Dr. Valladares directed that the regimen be continued.572 Patient 5“ error.569 StaffEx. 5.03.A at 1209. Staff Ex. 5.03.A at 1032. B was charged $125 for this SOAH DOCKET N O. 503-14-1342.MD PAGE 118 PROPOSAL FOR DECISION On February 24, 2011, Patient B presented at the Clinic and had his Vitals taken, and Dr. Valladares directed that the dosage of Votrient be increased};74 Patient B was charged $125 for this Visit with Dr. Valladares.575 On February 25 and 28, 2011, Patient B Visit with Dr. Valladares.573 presented at the Clinic and had his Vitals taken, and Dr. Valladares directed that the regimen be continued.576 Patient On March 1, B was charged $125 2011, Patient B for these Visits with Dr. Valladares.577 presented at the Clinic and had his Vitals taken, and Dr. Valladares directed that the dosage of Votrient be decreased.578 Patient B was charged $125 On March 2, 2011, Patient B presented at the Clinic and had Valladares directed that the regimen be continued.580 Patient B was for this Visit with Dr. Valladares.579 and Dr. his Vitals taken, charged $125 for this Visit with Dr. Valladares.581 On March 4, 2011, Patient B presented at the Clinic and had his Vitals taken, and Dr. Valladares discussed his future treatment preparatory to his initial discharge from the Clinic.582 Patient B was charged $200 for this visit with Dr. Valladares.583 With the exception of the undocumented office February 10, 2011, the charges for the office erroneous designation of the physician otherwise. 573 StaffEx. 5.03.A at 1210. 57“ StaffEx. 5.03.A at 1033. 575 StaffEx. 5.03.A at 1210. 57" StaffEx. 5.03.A at 1034-1035. 577 StaffEx. 5.03.A at 1211. 578 Staff Ex. 5.03.A at 1036. 579 StaffEx. 5.03.A at 1212. 58° StaffEx. 5.03.A at 1037. 58‘ StaffEx. 5.03.A at 1213. 582 Staff Ex. 5.03.A at 1037. 583 StaffEx. 5.03.A at 1213. who Visits actually Visit with Dr. Gregory Burzynski on of Patient B were met with the reasonable, and the patient did not establish SOAH DOCKET NO. 503-14-1342.MD Ms. Kloos testified Patient assumed that the monthly management fee being charged to B was “to take care of him on antineoplastons while he’s in Germany,” because she was of the opinion that was documented telephone fee billed under home that she PAGE 119 PROPOSAL FOR DECISION Once calls CPT Code health care. evaluation and all 585 was were insufficient to support Patient B was Ms. Kloos also asserted getting.584 that the B’s monthly case management 99499, because that code should only be used for patients receiving However, she management Patient the care that he later service,” not for agreed that Code 99499 is a code for “unlisted home health care services. 586 discharged from the Clinic, beginning in March 2011, the Clinic charged him a monthly case management fee of $3,511 per month through September of 201 1.587 Respondent argues that the services that justified this case management fee included, other things, the following: March 21, 2011— Respondent reviewed Patient B’s recommendations” to Dr. Brandt.588 May 24, 2011- Dr. progress.589 Marquis spoke to Dr. MRI and gave “further Brandt and discussed the patient’s June 16, 2011— the Clinic physicians evaluated a recent MRI of Patient B’s brain showing a significant increase in tumor size, and recommended that the patient return to Houston for a follow-up.590 July 1, 2011- Patient B returned to Houston where Dr. Marquis updated his history and conducted a physical.591 July 5 through 7, 2011- Patient was reassessed and modified.592 58“ 5“ 58" StaffEx. 68.02 at 67. StaffEx. 68.02 at 62. Tr. Vol.2 at 63. 587 Staff Ex. 33 at 22482-22489. 588 StaffEx. 5.03.A at 1041. 589 Staff Ex. 5.03.A at 1043. 59° Staff Ex. S.O3.A at 1044. 59‘ StaffEx. 5.03.A at 1057-59. B returned to the Clinic where his treatment plan among SOAH DOCKET NO. 503-14-1342.MD August 19, PAGE 120 PROPOSAL FOR DECISION 2011— Clinic staff held a conference call with Patient B and his family B decided to resume the treatment plan after overcoming the during which Patient side effects.593 September 9, 2011- Clinic staff spoke with Patient B’s family regarding his hospitalization.594 Respondent asserts that all these services, together with the cost covered by the monthly management fee, and points out treatment from the Clinic, only from Dr. Brandt while he The record establishes that the of the prescription drugs, were that Patient was in B never received ANP Germany. monthly case management fees charged to Patient B were reasonable. Ms. Kloos testified that Respondent improperly charged for prolonged service without contact and prolonged physician services because the times of the face-to-face contacts with licensed physicians were not documented in the medical records, nor did the records identify what services were being provided without physician contact. In addition, she stated that there was no documentation that licensed physicians performed the physical examinations or provided group health education as required by the On services February 7, and $500 for prolonged service without StaffEx. 5.03.A at Staff Ex. 5.03.A at 1052. 59“ StaffEx. 5.03.A. 5” at 1053. StaffEx. 68.02 at 67. 596 StaffEx. 33 597 StaffEx. 5.03.A. at 22376. at contact.596 B $60 each for group health education.597 1049-51. 593 B $350 for prolonged physician On February 28 and March 2, 2011, 2011, Respondent charged Patient Respondent charged Patient 5” CPT code used in the billings. 595 1212-1213. SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 121 In his briefs, Respondent does not point to any documentation or testimony to explain the charges for prolonged service without contact and prolonged physician services other than the office visit charges discussed above, or for the group health education charges. Accordingly, Staff has established that these charges are not sufficiently documented. From February 17 to March 2011, the Clinic charged for the intravenous 4, administration of medication to Patient B. Avastin at the Clinic on February Patient B started intravenous administration The same day, he signed 17, 2011. consent form that explained the purpose of the treatment and blocking receptors on the surface of endothelial cells.598 Avastin explained their purpose to the patient, be certain cancerous cell receptors or, for of common PB, it how it the Avastin informed inhibited cancer growth The consent forms for by PB, Votrient, and targeted gene therapy to block receptors to cause death in cancer cells of and increase the on activity chemotherapeutic agents.599 The records also established that with each drug the were discussed With the side effects patient, handouts were provided, and all questions were answered.600 The record to Patient establishes that the charges for the intravenous administration of medications B were reasonable. Staff also maintained that Respondent ran various tests such as blood and urine, lipid panel, and genetic testing that including the were medically unnecessary. Dr. Levin opined EGFR, HER2, plasma, and VEGF testing from Caris Life necessary and fully appropriate.601 therapy. In the June 17, These tests 5” Tr. v61. 2 at 63; StaffEx. 5.3.A at 1088, 909-911. StaffEx. 5.3.A at 909, 912, 915. 60° StaffEx. 5.3.A 60‘ Res. Ex. 165 at 51-53, 60-61. at Sciences, were medically were part of the treatment plan for targeted 2011 “Treatment Summary,” the patient wanted to follow Dr. Burzynski’s recommendations for a “Profile 598 that these tests, 1024 (Votrient), 1026 (Avastin). III, genetic markers x 4 and an MRI of the head SOAH DOCKET NO. 503-14-1342.MD without contrast.”602 The “Treatment Caris Target Summary” further explains that, based on the results of the scans, MRls, Summary, both Tarceva and Iressa were recommended. The pretreatment evaluation signed by nuclear medicine tests, Patient B explained that x—rays, blood studies, and urine studies were a series of required before a full treatment plan was developed.603 B Patient consent form for Avastin that explained that tests such as x-rays, medicine PAGE 122 PROPOSAL FOR DECISION CT CT tests that also signed the informed scans, MRI scans, nuclear and blood and urine lab studies were needed before the patient could tests, might be start Avastin or any target therapy agents.604 The record establishes and urine lab studies charged for the Lipid Panel test, that the x—rays, to Patient level, and genetic testing are fully (3). Summary of ALJs’ The ALJs find B were reasonable. The reasonable basis for the charges measurement of blood oxygen discussed in Section IV(B)(2) and 2. CT scans, MRls, nuclear medicine tests, and blood Analysis that the charge for the office February 10, 2011, the charges for the February 7, visit with Dr. Gregory Burzynski on 2011 prolonged physician services and prolonged service without contact, and the charges for group health education are not supported by the medical records, 602 “3 604 in violation of Code § 164.051(a)(3) and 22 TAC § 165.1. Staff Ex, 5.3.A at 1061-62. StaffEx. 5.3.A at 918. _ Staff Ex. 5.3.A at 909, 897 (Nexavar), 900 (Sprycel), 903 (Afinitor), 906 (Tarceva), 912 (Votrient), 915 (PB). C. Patient 1. In PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503—14-1342.MD 123 C Billings Appendix B to its Complaint, Staff asserts that the charges to Patient C Were improper, unreasonable, or medically or clinically unnecessary. Specifically, Staff cited the charges from May 11, 2010, through August 31, 2011, for office. consultations, prolonged service without contact, genetic testing, physician services, drugs, office/outpatient visits, blood measurements, medical supplies, phone calls, oxygen level and the monthly management fees (including unidentified fees). Ms. Kloos testified confirmed cancer that Patient C presented to the Clinic Without a pathologically diagnosis; this belief again apparently affected her opinion that none of the Clinic charges for his treatment were reasonable. cytology report dated April was reviewed by 5, 605 Patient C’s medical records contain a 2010, showing a diagnosis of mesothelium the Clinic’s doctors when Patient C This report May 11, 2010. In reported to the Clinic on addition, Patient C’s oncologist in Indiana, Dr. Waits, previously start cells.606 recommended that the patient chemotherapy drugs and undergo a surgical evaluation because he had cancer.607 Dr. Waits’s records from April 29, 2010, which were received by the Clinic in early June 2010, showed that Dr. Waits had diagnosed Patient C with “advanced mesothelioma caused by prior radiation therapy.”608 The record establishes that there support the Clinic’s treatment of Patient 605 StaffEx. 68.02 60" StaffEx. 5.04.A at 1351. 607 StaffEx. 5.04.A at1353. 6°“ Staff Ex. 5.04.A at 1573. at 74. was sufficient documentation C for cancer. in the medical records to SOAH DOCKET N O. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 124 In her expert report, Ms. Kloos took issue with the charges for office consultation and prolonged service without contact on May 11, 2011, the office outpatient visit on May 14, 2011, and the management fee on August 31, 2011, primarily because the wrong codes were used.609 The “Oncology Consultation” note dated May oncologist, identified those who, participated in the consultation, and tests and history were presented On May to the staff.610 by Dr. Joshi, a Clinic documented that Patient C’s 11, 2010, signed 11, $1,000 for the office consultation and $350 for prolonged service without contact.611 May 14, 2010, the records show that Patient C C On 2010, Respondent charged Patient presented at the Clinic and had his Vitals taken, and Dr. Marquis directed that the administration of PB be started.612 Patient C was charged $125 for this visit with Dr. Marquis.613 On May vitals taken, 2010, the records show that Patient and Dr. Marquis directed of Avastin be May 17, that the 18, 2010, the records show that Patient presented at the Clinic and had his dosage of PB be increased and the administration He was charged $125 started.614 C C for the visit with Dr. Marquis. 615 On presented at the Clinic and had his vitals taken, and Dr. Marquis directed that the dosage of PB be increased and the administration of Tarceva be started.616 $410 that He was charged $125 was adjusted to for the Visit with Dr. $66.63.” On May Marquis and a prolonged visit charge of 19,2010, the records show that Patient 0 presented at the Clinic and had his vitals taken, and Dr. Marquis directed that the administration of Nexavar be started.618 He was charged $125 609 StaffEx. 61.C.01 at 45190-45191. 61° StaffEx. 5.04.A at 1420. 6“ StaffEx. 5.04.A at 1582. 6’2 StaffEx, 33 6‘3 StaffEx. 5.04.A 6” StaffEx. 33 “5 StaffEx. at at 22891. 1585. 22891. 5.04.A 616 at at 1585. Staff Ex. 33 at 22906-22907. 6” StaffEx. 5.04.A at 1587. 61" StaffEx. 33 6‘9 StaffEx. 5.04.A at 1587. at 22914. for the Visit with Dr. Marquis.619 On SOAH DOCKET NO. 503-14-1342.MD PROPOSAL FOR DECISION May 20, 2010, C the records show that Patient and Dr. Marquis directed that Patient was charged $200 presented at the Clinic and had his Vitals taken, receiving Lisinopril for high blood pressure.620 He 621 establish that the charges for the initial consultation and the Visits of C with Dr. Marquis were reasonable. Ms. Kloos claimed case start for a visit with Dr. Marquis. The records Patient C PAGE 125 management that the Clinic The management fee for August, 31, 2011.622 Complaint included undefined fees management had insufficient documentation that, Respondent pointed fees. to to support the fees contested monthly by Staff in its based on the amount charged, were clearly monthly numerous progress notes evidencing that the Clinic actively monitored and participated in Patient C’s treatment in coordination with his local physician.623 Dr. Waits confirmed that he had several conference calls with doctors and staff at the Clinic.624 The record establishes that the monthly case management fees charged to Patient C were reasonable. From May 14, 2010, to July 30, 2011, the Clinic charged for the intravenous administration of medications to Patient C. On May intravenous administration of PB. The same day, Patient that explained the purpose of the treatment and at the Clinic on May 17, 2010. 625 2010, the Clinic charged for the C signed the PB informed consent form how it caused the activity of common chemotherapeutic agents. of Avastin 14, Patient death in cancer cells and increased C started intravenous administration The same day, he signed consent form that explained the purpose of the treatment and 62" StaffEx. 33 at 22918. 62‘ StaffEx. 5.04.A at 1588. 6” StaffEx. Vol. 68.02 at 78. 623 StaffEx. 5.04.A 62“ StaffEx. 66.0 “25 StaffEx. v61. 5.04.A at 1226-1228. at at 1356-1409; 1418-1436. 31-32; 60- 62. how it the Avastin informed inhibits cancer growth by SOAH DOCKET NO. 503-14-1342.MD blocking receptors on the surface of endothelial The cells. Nexavar were both adjusted downward by almost $3,000 that with all PAGE 126 PROPOSAL FOR DECISION initial charges for Tarceva and The records each.626 also established each drug the side effects were discussed with the patient, handouts were provided, and questions were answered. The record 627 establishes that the charges for the intravenous administration of medications and for medication prescriptions to Patient C were reasonable. Staff asserts that Respondent ran various genetic tests that were improperly billed and medically unnecessary. According to Dr. Burzynski as well as Dr. Waits, these medically necessary to create a personalized treatment plan.628 tests were Staff also maintained that the measurement of blood oxygen was medically unnecessary. The reasonable nature of the charges for the measurement of blood oxygen level and genetic testing are fully discussed in Section IV(B)(2) and (3). Staff asserts that the June 23, 2010, through March phone evaluation/maintenance charges of $125 each from 1, 2011, are improper. Ms. Kloos cited the phone calls with Dr. Marquis as having been coded incorrectly, while she pointed out that the call on November 23, 2010, was conducted by Ms. Acelar, an unlicensed physician. In his briefs, Respondent does not point to any documentation or testimony to support the telephone consultation August August 23, September 27, December 17, charges for June 23, July 2, 14, 2010, July 13, StaffEx. 5.04.B at 1583-1584. 627 StaffEx. 33 at 22906, 22914. 62“ StaffEx. 66.0 at 24. 27, August 10, and August 31, 2011. Accordingly, Staff has established that these charges are not sufficiently documented. 62° July SOAH DOCKET NO. 503-14-1342.MD The ALJs find July 2, December of Code D. 14, that the charges to Patient July 13, 27, August 10, C for the telephone consultations for June 23, August 17, August 23, September 27, and 2010, and August 31, 2011, are not supported by the medical records, in violation § 164.051(a)(3) Patient and 22 TAC § 165.1(a). D Billings 1. In 127 Summary of ALJs’Analysis 2. July PAGE PROPOSAL FOR DECISION Appendix B to its Complaint, Staff asserts that the charges to Patient D were improper, unreasonable, or medically or clinically unnecessary. Specifically, Staff cited the charges from June 7, 2011, for office consultation, prolonged service without contact, and genetic testing. Staff also alleged that unspecified charges even though Patient 8 through July 1, 2011, were unreasonable D received no treatment or billings for those dates. Ms. Kloos opined prolonged from June initial consult, that the billing for the office visits on June were not supported by the records. Patient D’s medical record contained 76 pages of reports 629 7, 2011, specifically the Respondent points out that from Patient D’s other providers that the Clinic’s physicians reviewed before the initial meeting, as well as Dr. Marquis’s detailed summary of Patient D’s history and the initial consultation.630 were justified because Patient recommendation and testing.631 6” Patient StaffEx. 61 cm D that part came to the Clinic for a that the tests second evaluation and treatment of that evaluation included undergoing the genetic profile signed the Pre—treatment Evaluation form agreeing to undergo the various at 17. 63° Staff Ex. 5.01.A at 388-463. 63‘ StaffEx. 5.01.A at D Respondent argues 373. tests including blood, urine, PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD nuclear medicine tests, scans, and x—rays 128 that the Clinic routinely administered in order for the physicians to create a treatment plan.632 The medical records support the reasonableness of the charges to Patient D for the initial consultation and prolonged services without contact, as well as the genetic testing. Summary of ALJs’ 2. The ALJs find no violations Patient E. as alleged regarding the billings to Patient D. E Billings 1. In Analysis Appendix B to its Complaint, Staff asserts that the charges to Patient E were improper, unreasonable, or medically or clinically unnecessary. Specifically, Staff cited the charges from September 7 through 16, 2011, for office consultations, prolonged service without contact, genetic testing, medical services after hours, drugs, office/outpatient visits, blood measurements, Lipid Panel, and the monthly management Ms. Kloos testified CPT Codes that Patient 99358, 99359, and 99212.633 $1,000 was agreed to by Patient E E was level visits using fees. improperly charged for office The September in writing,634 oxygen 7, 2011 initial consultation fee of and included review by the Clinic physicians of nearly 100 pages of records from Patient E’s prior providers, Weill Cornell Medical Center and New York Presbyterian.63 5 report provided an extensive Dr. Yi’s Initial Oncology Assessment and History and Physical summary of Patient E’s medical history regarding his previous CT “2 StaffEx. 5.01.A. at 312. 6” StaffEx. 68.02 at 83-86. 63“ 635 StaffEx. 5.05.A at 1802. Staff Ex. 5.05.A at 1747-1785 (records York Presbyterian). from Weill Cornell Medical Center); 1696-1,744 (records from New SOAH DOCKET NO. 503-14-1342.MD scans, biopsies, surgical history, showed These services were reflected On September initial 8, in the administration of 2011, the records show that Patient PB be Patient started. E presented E was charged $100 2011, the records show that Patient and discussed his administration of pointed out that consultation also prolonged service without contact charges of $500.636 at the Clinic and Dr. Yi directed that he do a 24—hour urine protein Vitals taken, 9, and prior treatment. The note for the 129 Yi and Respondent reviewed prior laboratory findings and radiology films. that Dr. September PAGE PROPOSAL FOR DECISION symptoms and Xgeva be is E was Patient and that the for this visit.637 On presented at the Clinic, had his Vitals taken, the blood test results, and Dr. started. CPT Code 99212 E test and had his charged $100 for used for a patient office visit Yi directed this visit.638 that that the Respondent of approximately 10 minutes addressing “minor” issues. On September his Vitals taken, $75 for Clinic, $75 for show that Patient E presented at the Clinic and had and Dr. Yi directed that the dosage of PB be increased. Patient E was charged this visit. had 10, 2011, the records 639 On September his Vitals taken, this visit. 640 On 11, 2011, the records show that Patient E presented at the and Dr. Yi directed he continue the regimen. Patient E was charged September 14, 2011, the records show that Patient E presented at the Clinic and had his Vitals taken, and Dr. Yi directed that the administration of ‘Afinitor (everolimus) be started. Patient the records show that Patient E E was charged $100 for this visit.641 On September 15, 2011, presented at the Clinic and had his Vitals taken, and Dr. Yi directed that the administration of Sutent be started and the patient be prepared for discharge. Patient $100 E was charged $200 for an office visit, for 636 StaffEx. 5.05.A 637 Staff Ex. 33 at 22648-22649. 63* StaffEx. 33 639 Staff Ex. 33 at 22654-22655. 64° StaffEx. 33 at 22657-22658. 6‘“ StaffEx. 33 at 22672-22673. 642 Staff Ex. 33 at 22674-22675. at at which there 1615-1625. 22651-22652. for this visit.642 is On September no documentation. 16, 2011, Patient E was charged The medical records establish, with the exception of the September 16, 2011 charge, the reasonableness of the charges to Patient contact, and office On PAGE 130 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD E for the initial consultation, prolonged services without visits. September 10 and 11, 2011, Patient E was charged $95 each day for after-hours medical services. Respondent has not referenced any notes to indicate after-hours medical services being provided on September 10 or 11, 2011. Accordingly, those charges are not supported by the medical records. Staff asserts that Respondent ran various genetic tests that were improperly billed and medically unnecessary. Staff also maintained that the Lipid Panel and the measurement of blood oxygen were medically unnecessary. The reasonable nature of oxygen, and Lipid Panel is the charges for the genetic testing, discussed in Section IV(B)(2) and From September 7 through 15, measurement of blood (3). 2011, the Clinic charged for the intravenous administration and prescription of medications to Patient E. On September began the intravenous administration of PB. The same day Patient E 8, 2011, the Clinic signed the PB informed how it caused death incancer cells and increased the activity of common chemotherapeutic agents.643 On September 13, 2011, Patient E began receiving Xgeva. On September 14, 2011, Patient E began receiving Afinitor, consent form that explained the purpose of the treatment and the informed consent form for which was signed on September 13, 2011. The “purpose of the treatment” section in the form describes Afinitor as a kinase inhibitor indicated for the treatment of patients with advanced renal 6“ Staff Ex. Vol. 5.05A at 1795-1797. cell carcinoma after failure of treatment with Sutent or SOAH DOCKET NO. 503-14-1342.MD Nexavar. 644 set forth in effects PAGE 131 PROPOSAL FOR DECISION (The discussion regarding the simultaneous administration of Afinitor and Sutent is Section IVFl, 2, and 3 above.) The records establish that with each drug, the side were discussed with the patient. 645 Staff cited to no evidence explaining why the drug charges were unreasonable. The record establishes that the intravenous administration of PB and the prescribed medications and their costs On charged to Patient September 8, B were reasonable. 2011, Patient E had a nutritional consultation with Madhavi Raju that was reviewed by Dr. Gregory Burzynski and for which Patient E was charged an adjusted amount of $255.646 Staff has provided no evidence as to why this charge was not medically necessary. Staff alleges that Respondent improperly charged Patient management in writing fee on September on the first day he 15, 2011. Patient E a $4,500 monthly case E agreed to pay this monthly case management Visited the Clinic.647 Respondent points out that the Clinic only charged one monthly case management fee even though the Clinic monitored Patient E through October and November 201 1.648 The record establishes that the single was reasonable. 64“ StaffEx. 5.05.A 6‘” StaffEx. 33 6“ at at 1789-1791. 22667. StaffExs. 5.05.A at a 1613-1614; 33 at 22640. 6a 7 StaffEx. 5.05.A at 1802. 64“ StaffEx. 5.05.A at 1626-1631. monthly case management fee charged to Patient E SOAH DOCKET N O. 503-14-1342.MD Summary of ALJs’ 2. The ALJs find that the Analysis office visit charge for September 16, 2011, and the after-hours E medical services charges for September 10 or 11, 2011, to Patient medical records, in violation of Code § 164.051(a)(3) and 22 F. Patient TAC § are not supported by the 165.1(a). F Billings l. In PAGE 132 PROPOSAL FOR DECISION Appendix B to its Complaint, Staff asserts that the charges to Patient F were improper, unreasonable, or medically or clinically unnecessary. Specifically, Staff cited the charges from October 8 through November 11, 2009, for office consultations, prolonged evaluation, genetic testing, drugs, office/outpatient visits, Ms. Kloos testified his initial consultation $1,000 for the initial blood oxygen level measurements, and the Lipid Panel. that Patient F’s medical records on October 8, 2009.649 Patient do not support F signed albilling billing Patient F for agreement to pay the consultation and the $500 charged for evaluation of his medical records.650 Dr. Weaver’s “History and Physical” concerning Patient F documented that he: (1) reviewed extensive medical documents pertaining to the consultation, including the patient’s biopsy results, ultrasounds, CT scans, prior doctors’ recommendations, lab reports, and other past medical and surgical history; (2) thoroughly examined the patient; and (3) developed a plan of treatment from that examination.651 On October 9, 2009, the records show that Patient F presented taken, and Dr. Weaver directed that the administration of at the Clinic, PB and Rapamune had be his Vitals started, that Zolinza be started on October 11, that Xeloda be started on October 13, and that his existing 649 Staff Ex. 68.02 at 87- 88. 65° StaffEx. 6.01.A 65‘ Staff Ex. 6.01.A at 2032-2035. at 1960. SOAH DOCKET NO. 503-14—1342.MD dosage of Valtrex be increased.652 (The issue of the Valtrex dosage IVGl). Patient F was charged $125 for F presented that Patient Patient at the Clinic F was charged $125 F presented at the Clinic, for discharge. 656 Patient this visit.653 and had for each visit.655 had his PAGE 133 PROPOSAL FOR DECISION The medical records support his Vitals taken, On October Vitals taken, F was charged $200 On October is discussed in Section 12-16, 2009, the records and met with Dr. Weaver. and met with Dr. Weaver prior the charges to Patient 654 2009, the records show that Patient 19, for this visit. show to being prepared 657 F for the reasonableness of the initial consultation, prolonged evaluation, and office visits. Staff asserts that Respondent ran various genetic tests that were improperly billed and medically unnecessary. Staff also maintained that the Lipid Panel and the measurement of blood oxygen were medically unnecessary. The reasonable nature of the charges for the genetic testing, oxygen, and Lipid Panel are discussed in Section IV(B)(2) and From October 9 through November 11, began the intravenous administration of PB and the and how agents.658 652 6” it StaffEx. 6.01.A at 2049. StaffEx. 33 at 22683. StaffEx. 6.01.A 655 Staff Ex. 33 at 22684—22687. 656 StaffEx. 6.01.A at 2044. 6” October 9, of Rapamune. The same that explained the purpose and increased the activity 2009, the Clinic of the treatment of common chemotherapeutic That same day, Patient F signed the Rapamune informed consent form that explained 65“ “7 cells On oral administration F signed the PB informed consent form caused death in cancer (3). 2009, the Clinic charged for the intravenous administration and prescription of medications to Patient F. day, Patient measurement of blood StaffEx. 33 at at 2045-2048. 22688. StaffEx. Vol. 6.01.A at 1980-1982. SOAH DOCKET NO. 503-14-1342.MD purpose of the treatment was to suppress the body’s that the PAGE PROPOSAL FOR DECISION immune system. 134 On October 659 11, 2009, Patient F began receiving Zolinza, the informed consent form for which was signed on October 9, 2009.660 On October 13, 2009, Patient F began receiving Xeloda, the informed consent form for which was signed on that same date.“ The records established that with each drug, the side effects were discussed with the patient.662 why the drug charges were unreasonable. The administration of PB and the prescribed medications and Staff presented insufficient evidence as to record establishes that the intravenous their costs charged to Patient F were reasonable. Summary of ALJs’ 2. The ALJs find no G. Patient violations as alleged regarding the billings to Patient F. G Billings 1. In Analysis Appendix B to its Complaint, Staff asserts that the charges to Patient G were improper, unreasonable, or medically or clinically unnecessary. Specifically, Staff cited the charges from August 31 through November 14, 2012, for office consultations, group health education, medical equipment, intravenous infusions, drugs, office/outpatient visits, testing, blood oxygen level measurements, Lipid Panels, nutritional therapy, and after-hours medical services. Patient G was entered August3l, 2012, Patient G into a single patient protocol to receive StaffEx. Vol. 6.01.A at 1973-1976. 6"" StaffEx. Vol. 6.01.A at 1977-1979. 66‘ StaffEx. 6.01.A at 1970-1972. StaffEx. 6.01.A at 2049. treatment. agreed in the Billing Agreement to pay $1,250 for the 659 “2 ANP On initial SOAH DOCKET NO. 503—14-1342.MD consultation.6 63 PAGE 135 PROPOSAL FOR DECISION The History and Physical notes by Dr. Marquis indicate that the Clinic physicians conducted a comprehensive review of the patient’s medical history and a physical examination, and began formulating a treatment plan.664 On September 13, 2012, Dr. Marquis’s progress note reported that he examined Patient G, analyzed the lab reports, and Patient F was charged $125 modified for this visit.666 On Patient G’s treatment plan to increase ANP.665 September 14, 2012, Dr. Marquis reported that G was he examined Patient G, analyzed the lab reports, and again increased ANP.667 Patient charged $125 for a visit with Dr. Valladares, a clerical error.668 On September 15 and 16, 2012, Dr. Marquis reported that Patient G’s Vitals were checked, and that he observed her bipedal G edema, and again increased ANP.669 Patient September 17 through 21, 2012, Patient G met with Drs. Marquis or Yi and each time her ANP was increased.671 Patient was erroneously shown G was charged $125 was charged $75 for each Visit.670 (The September 18, 2012 charge for each Visit. as being for Dr. Gregory Burzynski.)672 On September 22 Dr. Yi reported that Patient G’s Vitals were checked and he held the Patient G was charged $75 for each visit. “4 “5 Staff Ex. 7.06.M at 3522. Staff Ex. 7.01 at 2434-2438. StaffEx. 7.01 at 2533. “6 StaffEx. 33 “7 at StaffEx. 7.01 “8 “9 67° 6“ 22605. at 2532. StaffEx. 33 at 22607. StaffEx. 7.01 at 2530-2531. Staff Ex, 33 at 22609, 22611. StaffEx. 7.01 at 2525-2529. 672 Staff Ex. 33 at 22609, 22611. 673 StaffEx. 7.01 at 67“ StaffEx. 33 22624, 22626. at 2523-2524. ANP and 23, 2012, dosage steady.673 (The charges were erroneously showed as being for Dr. Gregory Burzynski or Dr. Marquis, respectively.)674 “3 From On September 24, 2012, Dr. Yi SOAH DOCKET NO. 503-14-1342.MD reported that Patient G’s Vitals were checked and he stopped the charged $125 for this visit, On September 25, PAGE 136 PROPOSAL FOR DECISION again erroneously ANP dosage.675 Patient G was shown with Dr. Marquis.676 2012, Dr. Marquis’s progress note recorded that he met with Patient G about her recent issues with edema and that Respondent recommended that she stay off ANP and remain in Houston for an additional week so the Clinic could monitor her condition.677 Patient was charged $200 The record Patient G for this visit, erroneously G shown with Dr. Gregory Burzynski.678 establishes that the charges for the initial consultation and office visits of were reasonable, and the erroneous designations of the physician who actually met with the patient do not establish otherwise. On September 15, 16, and 23, 2012, Patient G was charged $95 each for after-hours medical services. Progress notes for September 15, 2012, signed by Dr. Marquis indicate that Patient G called the Clinic at 8:30 pm. regarding a malfunctioning pump, which was then reprogrammed. The records support the charge for September 15, 2012. However, Respondent has not referenced any notes to indicate after-hours medical services being provided on September 16 or September 23, 2012. Accordingly, those charges are not supported by the medical records. On September infusions. see how The 12, G received two ANP After Patient G was observed to 2012, the medical records document that Patient first infusion was Atengena (one type of ANP). she tolerated the infusion, she was given the prolonged infusion of “Astugenal”———a 675 StaffEx. 7.01 at 2522. 67" StaffEx. 33 677 StaffEx. 7.01 at 57" StaffEx. 33 22630. at at 22628. 2521-2522. SOAH DOCKET NO. 503-14-1342.MD different infusion. G was ANP.679 Patient PAGE 137 PROPOSAL FOR DECISION charged $170 for the first infusion and $395 for the second 680 MS. Kloos testified that Respondent improperly billed Patient G for the September 12 IV push and prolonged chemotherapy infusion because there was no time recorded or documentation of satisfy the who performed the infusions.681 Respondent replied that the progress notes coding requirements because they indicated that Patient G was being monitored during the infusions by a healthcare professional. Although the record establishes that the place, nothing in the progress notes cited present during the infusion. September 2012 infusions of Patient 12, G took by Respondent identify a health professional who was Accordingly, these two billings are not supported by the medical records. From September for 13 through 22, 2012, Patient which she was charged $395 each. through 27, November 1, ANP the infiisions were coded as at pump 14, through October 19, October 23 2012, Patient CPT Code No. billing for daily administration to a letter and was not an Code 96416 is the proper code to use of ANP (not effort to when ANP 682 StaffEx. 7.01 at 68° StaffEx. 33 22504. 6 on ‘ StaffEx. 68.02 at 67-68. “2 Staff Ex. 68.02 at 67-68. 2487, 2534. given through Respondent argues that the overcharge the patient or her insurance. Respondent points Association’s Department of Coding requesting clarification on 679 is ANP itself) was an issue for which the Clinic sought from the Clinic’s former Account Receivables Manager at self-administered the 96416. continuously by a nurse or other licensed health provider. clarification, G her home. She was charged $395 for each of these infusions as well. All ‘Ms. Kloos testified that a On September 29 and November 5 through infusions of G received infusions of ANP at the Clinic to the American Medical how to bill for administration of SOAH DOCKET NO. 503-14—1342.MD ANP but did not receive a determination other than that the designate the specific PAGE 138 PROPOSAL FOR DECISION CPT Code Manual does not ANP agents that are to be administered. 683 Although the record establishes that the infusions of Patient G took place, nothing in the who was progress notes cited by Respondent identify a health professional infusions in the Clinic. Accordingly, those billings are not supported present during the by the medical records. As for the charges for the self-administered infusions, although the record establishes that the self- by the G took place, the coding used by the Clinic indicated they were administered Since Respondent argues that these charges were for the administration of ANP by Patient infusions Clinic. and not the costs of the medication In addition, there infusion. is to Patient are not supported by the medical September According Respondent argues record. to be trained on Patient G Houston with for billings for Patient G’s self- records. that billings for that Patient Respondent, to been no G, as elsewhere asserted by Respondent. Accordingly, those billings 12, 13, 14, 17, 18, 19, 20, do not document there should have nothing in the records to indicate that these charges were for the shipment of ANP Ms. Kloos testified itself, all G “group education” under CPT Code 99078 for and 21, 2012, were improper because the medical records received education from a physician in a group setting.684 of the group education codes were supported by the medical that, because Patient G qualified to receive ANP treatment, she had how to administer it when she returned home. The consent form for treatment of ANP includes the requirement that she and her family two weeks for training in monitoring the infusion members remain pump and in replacing the bag ANP as the bag’s contents are used.685 Dr. Marquis noted in the medical record that he explained to Patient G that the training would last a few weeks during which they would be taught how to prepare IV ANP bags, calculate the appropriate dosages, draw blood, calculate containing the and inject IV steroids, and care for the central 6 on 3 Staff Ex. 64.B4 at 45892-45893. 68“ Staff Ex. 68.02 at 93-94. “5 6 on 6 StaffEx. 7.1 at 2449—2455. StaffEx. 7.1 at 2438. line.686 SOAH DOCKET NO. 503-14-1342.MD On September 12, appropriate diet while on 2012, Patient G ANP treatment, was counseled by someone about for Worksheets document that she attended the which she was charged $60 for for each G birth control and which she was charged $60.687 Patient G’s Daily ANP training from September 13 through 21, 2012, day of training.688 The problem with Respondent’s argument Patient PAGE 139 PROPOSAL FOR DECISION that, is while the records indicate that did receive the training in a group, albeit small, the medical records do not establish that the training was provided by a physician. Accordingly, the billings are not adequately supported by the medical records. Dr. Wetmore opined that comprehensive metabolic panel and Agreement in the Billing more.69 0 Patient G G for tests like the Respondent noted that Patient G was advised Respondent frequently overcharged Patient lipid panel. 689 that lab testing after the initial consultation could cost $3,500 or During her history and physical, Dr. Marquis documented that he explained blood that tests were required as part of the FDA to approval process for the single patient protocol.691 Patient Staff presented no expert testimony to support its G As unnecessarily for various medical supplies. blood oxygen levels, these issues are discussed in Section On September 18, 2012, Patient certified nutritionist, and and “7 lifestyle.692 was provided StaffEx. 7.1 at 2534. StaffEx. 7.1 689 Staff Ex. 68.03 at 69-70. 69° StaffEx. 7.6.M at 3522. 69‘ StaffEx. 7.1 at 2438. 692 StaffEx. 7.1 at 2528. ‘93 StaffEx 33 at at 2710-2714; 2717—2718. 22528. Respondent charged for the lab testing and the tests for IVB2 and 3. G had a nutritional consultation with Debbie Bertland, a additional educational materials concerning a healthy diet She was charged $300 for this consultation. 68“ allegations that 693 SOAH DOCKET NO. 503-14-1342.MD Staff has provided no evidence as to Summary of ALJs’ 2. The find ALJs ' PAGE PROPOSAL FOR DECISION 140 why this charge was not medically necessary. Analysis the that charges after—hours for medical on services September 16 or 23, 2012, the charges for the September 12 through 22, 2012 infusions of ANP at the Clinic, the October 19, charges for the self—administered infusions of October 23 through 27, November 1, ANP on September 29 through and November 5 through 14, 2012, and the charges for group health education are not supported by the medical records, in violation of Code § 164.051(a)(3) IX. Patient F and 22 TAC § 165.1(a). DECEPTIVE MARKETING AND ADVERTISING initially sought treatment by the Clinic with ANPs in part due to reading or viewing statements referenced on the website of the Clinic, but he and his wife were informed the initial consultation that he did not qualify for The Clinic’s A through Patients ANP treatment.694 and BRI’s websites during the period covered by the Complaint regarding G (October 8, 2009 through November 26, 2012) contained several statements that were objected to by the Thomas N. Moreno, Acting Office FDA. In a letter dated October for Drug Evaluation and Research of Respondent that certain claims on the Clinic website suggested that effective for the treatment of various types of brain tumors Moreno requested 18, 2012, Director of the Office of Scientific Investigations of the Office of Compliance of the Center those uses. Mr. at that the Clinic the FDA ANPs were notified safe when they had not been approved and for and BRI discontinue use of those promotional materials.695 In a follow-up letter dated January 10, 2013, Kendra Y. Jones, Regulatory Review Officer of the Division of Consumer Drug Promotion of the Office of Prescription Drug Promotion of the FDA notified Respondent that even though changes had been made to the websites, there were continued claims and presentations that promoted the use and efficacy of 69“ 695 Tr. Vol.9 at 140-146. Staff Ex. 4.02 at 283-291. ANPs, and requested that those claims April 17, 2013, Ms. Jones stated that the websites and the matter PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD all and presentations be discontinued.696 In a letter 141 dated of the objectionable materials had been removed from was now closed.697 As of October 2012, the Clinic website stated in several places that ANP therapy was the FDA supervised clinical trials and that only patients eligible to enroll in such trials could receive ANP treatments. It further stated that patients not eligible for a clinical trial may receive the approval of FDA to enroll for ANP treatment on an individual basis.698 subject of In its Brief, Staff merely restates the allegation in, its Complaint with cites to the websites FDA correspondenCe regarding them, but makes no argument as how those cites support its allegation. However, as discussed below, FDA concerns about possible violations of noncriminal federal regulations that were resolved to the satisfaction of the FDA are not the basis for and the determining that violations of the Texas statutes or rules have occurred. Staff also cites to deposition testimony of Clinic employees to support its allegation. Those statements merely established that patients had learned about the Clinic and ANP from the websites and other sources and that they were interested in pursuing alternative therapy because conventional therapy had not worked. However, there misled prospective patients into thinking that because certain patients, it no evidence ANP had that Respondent’s websites been successfully used to treat could or would be used in their individual treatments. Accordingly, Staff has failed to establish that Respondent used advertising statements that were deceptive, in violation of Code § l64.052(a)(6). 696 StaffEx. 12 697 Staff Ex. 12 at 7031—7033. 698 StaffEx. 1.04 at is 7004-7009. at 30, 35. false, misleading, or SOAH DOCKET NO. 503-14-1342.MD ETHICAL AND PROFESSIONAL RESPONSIBILITIES699 X. As PAGE 142 PROPOSAL FOR DECISION discussed above in Section I, in Order No. 7 the ALJs partially granted Respondent’s motion for summary disposition disposing of certain allegations raised by Staff in regards to Respondent’s ethical and professional responsibilities as the principal investigator of studies. § l64.053(a)(1) of the Code defines “unprofessional or dishonorable conduct that likely to deceive, defraud, or injure the public” as including the “violates state or federal The Board has clinical law if the act is commission of an is act that connected with the physician’s practice of medicine.” interpreted that section of the statute in Board Rule 190.8(2)(R) its rules. expressly identifies the violations of “federal and state laws whether or not there is a complaint, indictment, or conviction” that constitute unprofessional and dishonorable conduct. This subsection clarifies that the violations of federal law that the Board has determined constitute unprofessional or dishonorable conduct are criminal in nature. This subsection of the rule does not expressly state that this is The ALJs concluded § 190.8(2)(R), the a nonexclusive Order No. 7 in as list, that, Board has interpreted Code do other subsections. TAC based on the specific language of 22 § 164.053(a)(1)’s reference to federal laws to apply to those related to criminal violations of federal law. Accordingly, the alleged violations of non-criminal FDA regulations regarding promotional statements and the violation of regulations regarding Phase 2 clinical studies do not constitute violations of 22 § 190.8(2)(R), and, therefore, do not violate Code FDA TAC § l64.053(a)(l). Staff accused Respondent of having a conflict of interest serving as both principal clinical investigator and sponsor. BRI The documentary evidence is indicates that the FDA is Respondent and BRI and has approved the applications investigator and BRI as the sponsor. “investigator” and “sponsor,” 699 it owns 80% of BRI’s the sponsor; however, Respondent also Notably, the FDA stock. aware of the relationship between listing Respondent as the principal regulations define not only the terms defines a “sponsor-investigator” Pursuant to Order No. 34, the ALJs will consider only those patients discussed Claims about other patients are deemed waived. to mean “a person who in the parties’ closing arguments. SOAH DOCKET NO. 503-14-1342.MD both initiates PAGE PROPOSAL FOR DECISION and actually conducts, alone or with apparent acknowledgement by the FDA others, a clinical investigation.”700 that there is no conflict of interest for 143 Thisin an Respondent to serve as both principal clinical investigator and sponsor. A. Failure to Protect Patients As G and I through BB in Clinical Trials a clinical investigator,701 Respondent was responsible for complying with statutes and rules applicable to clinical investigations,702 including Staff, 21 federal Code of Federal Regulations regulations investigators. An governing investigator is the Board Rule 200.3(7).703 According (C.F.R.) §§ 312.3(b), 312.50, and 312.60 are the primary ethical and professional responsibilities of clinical responsible for “protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the control of drugs under investigation” ensuring that the investigation investigational plan, is to by conducted according to the signed investigator statement, the and applicable regulations.704 BRI was the sponsor of the Clinic’s clinical studies. As the sponsor, BRI was responsible for the following: selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining and all an effective IND with respect to the investigations, and ensuring that FDA 70° 21 Code ofFederal Regulations (C.F.R.) § 50.3(0. According to 21 CPR. § 312.3, an “investigator” is “an individual who actually conducts a clinical investigation In the event an (i.e., under whose immediate direction the drug is administered or dispensed to a subject). investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. ‘Subinvestigator’ includes any other individual member of that team.” 701 702 21 C.F.R. § 312.03(b) defines “clinical investigation” to mean “any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.” 22 TAC § 200.3(7) requires clinical investigators to ensure that the clinical studies are part of a systematic program, have the same concern and caution for the welfare of the patient as in a non-clinical investigation, and have patients signed informed consent forms compliant with federal regulations. 703 70“ 21 C.F.R. § 312.60. SOAH DOCKET N O. 503-14—1342.MD PAGE 144 PROPOSAL FOR DECISION participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.705 Staff asserts that Respondent violated his ethical and professional responsibilities as a clinical investigator towards patients in clinical studies in violation of Board Rule 200.3706 by: (l) failing to adhere to established standards protect Patient trial of scientific research; (2) failing to adequately G and Patients I through BB, who were being treated with ANP in either a clinical or as an expanded access patient; (3) destroying imaging measurements or failing to maintain the patients” underlying imaging as part of the medical records; and (4) overprescribing corticosteroids.707 Staff also maintains that Respondent misrepresented the' tumor responses that Patients Q, R, V, W, X, Y, Z, AA, and BB had to ANP treatment and that these patients experienced serious adverse events that Respondent did not report to BRI, and ultimately to the FDA.708 Dr. Fost explained that it is the physician’s duty learn whether the patient wants treatment, “whether To do practice.”709 705 7"“ so, he said, the patient it’s when treating adult cancer patients to experimental or just standard clinical must be informed about the risks and benefits of CPR. § 312.50. IND is the acronym for “investigational new drug.” 22 TAC § 200.3(7)(A) and (B) state: 21 (7) Clinical Investigations, Physicians using conventional medical practices or providing complementary and alternative medicine treatment while engaged in the clinical investigation of new drugs and procedures (a.k.a. medical research, research studies) are obligated to maintain their ethical and professional responsibilities. Physicians shall be expected to conform to the following ethical standards: (A) Clinical investigations, medical research, or clinical studies should be part of a systematic program competently designed, under accepted standards of scientific research, to produce data that are scientifically valid and significant; A clinical investigator should demonstrate the same concern and caution for the welfare, safety and comfort of the patient involved as is required of a physician who is furnishing medical care to a patient independent of any clinical investigation; (B) 707 StaffEx. 65, Vol. 14.09.L 708 Staff’s Closing AA, and BB and N, Patients H, I, J, Q, R, V, Z, 70" S, T, 46162. Staff asserts that Respondent misclassified Patients Q, R, V, W, Y, Z, failed to report their adverse events, Staff only discussed these allegations in reference to O, P, S, T, and U. The issue regarding informed consent Staff asserts pertained to Patients 1, J, N, Argument at 63. Although AA and BB. StaffEx. 68.01 at at 17. SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION According to Dr. Fost, a physician must proposed treatment and any alternative treatments. respect the adult patient’s “autonomous preferences” even if the adult patient that may violate their own interests ”710 145 However, when Dr. Fost maintained, the physician has a different duty. makes “decisions treating pediatric cancer patients, The physician must honestly and candidly discuss with the child’s legally authorized representative the types of treatments available and the associated risks and benefits, and must also do what the child’s “best is in interest.”711 Respondent disagrees with federal and state Staff‘s allegations and adamantly requirements in treating these patients in a clinical he met both the asserts that trial. As a threshold issue, however, Respondent objected to Staff’s addition of “failure to protect” allegations regarding Patients H and CC in its closing argument because Staff did not plead these allegations in the Consequently, Respondent requested that the ALJS disregard these allegations. Complaint.712 The ALJs CC agree. Therefore, Staff’s allegations that Respondent failed to protect Patients Texas Government Code in a clinical trial will not be considered, in accordance with However, Patients §2001.052. H and CC H and were cited in the Complaint for other ethical violations and will be addressed in the appropriate section. Respondent questioned Dr. Fost’s expert opinions because Dr. Fost admittedly did not interview the patients or the patients’ families; did not review most of the medical records;713 and could not recall what records he reviewed regarding Patients H through BB.714 Although Dr. Fost acknowledged that Respondent’s cancer patients had poor prognoses, he could not remember if most of these patients had terminal cancer or had already treatment without success.715 71° 7“ m Tr. Vol. 1 at 160; 7” “5 on the assumption that the at 18. StaffEx. 68.01 at 17-18. Regarding the Complaint. 7‘3 StaffEx. 68.01 Instead, Dr. Fost based his opinions tried conventional cancer failure to protect allegations, Staff only cited to Patients 163—164. Tr. Vol. 1 at Tr. Vol. 1 at 184. Tr. Vol 1 at 172-173. A through G and I through BB in its SOAH DOCKET NO. 503-14-1342.MD preliminary that a PAGE 146 PROPOSAL FOR DECISION FDA findings referenced in the 2013 warning letter were true even though he agreed warning letter “in Respondent points out and of itself does not mean that there’s been an ethical violation.”716 that Dr. Fost could not identify concerning Patients I through whether the Board’s allegations BB dealt with any FDA issues.717 Respondent emphasizes that Patients G and I through BB were previously diagnosed with terminal cancer and had either rejected convention treatment or had conventional treatments fail. Dr. Fost, agreed that traditional cancer treatments, such as radiation and Staff‘s expert, chemotherapy, had already failed many of Respondent’s Board Rule 200.3(7) does not require a physician is traditional cancer treatments have deadly side who emphasized that the According to Respondent, to ensure to a patient that the risk associated reasonable in relationship to the anticipated benefits because even with the proposed treatment Dr. Levin, patients.718 effects. has oncology experience in both academic and private practice settings, FDA heavily monitors and scrutinizes clinical studies. He noted that the layers of federal oversight that apply in a clinical trial setting, including record keeping, do not usually apply to an oncologist in private practice.719 Dr. Burzynski represented that “serious, unexpected, known it was only necessary and causatively related side effects, he clarified, did not to report adverse events that to the investigation of the agent.”720 Expected and need to be reported. Dr. Burzynski explained that Clinic, the subinvestigators (other physicians) reported all adverse events to the principal investigator in the FDA-approved clinical trials. He events that were serious, unexpected, and causatively related to Ultimately, 7‘6 7” BRI reported the Tr. Vol. 1 at 194-195. Tr. Vol. 1 at 184. 7‘8 Tr. Vol. 1 at 166. 719 Resp. BX. 165 72° Tr. Vol. 8 at 68. 72‘ Tr. Vol. 8 at 82-83. at 6. adverse events to the FDA.721 were at the him because he was then reported those adverse ANP to the sponsor, BRI. SOAH DOCKET N O. 503-14-1342.MD PAGE 147 PROPOSAL FOR DECISION According to Protocol BT-lOm, the investigator had to report any adverse reactions that were “unexpected and Protocol BT-lO, the fatal or life threatening” or are known side effects of ANP “unexpected and serious.”723 According to included the following: Central nervous system toxicity including blurred Vision, ringing in ears, hearing loss, headache, dizziness, slurred speech, hallucinations, depressions, tiredness, mood changes, sleepiness, polyneuropathy (numbness and tingling) and thickening of the skin, arrhythmia (changes in your heart rate), nausea, vomiting, diarrhea, anemia, increase of blood pressure, swelling, fluid retention or fluid loss (both of which may be serious), weakness, electrolyte imbalance including: decrease of calcium, sodium, potassium, magnesium, and or increase in sodium concentration in blood (forgetfulness, confusion, cramps) which in extreme cases may become life—threatening. Other side effects include: Decreased white blood cell count which can result in an increased chance of infection, a decrease in platelet count, (increase[d] chance of bleeding), blood in the urine, an elevated bilirubin which can result in jaundice (yellowing of the skin and whites of the eye), fever chills, skin rash, muscle aches, joint pain, abdominal pain. There is a possibility of liver toxicity, increased urination, increased thirst. You many also experience a metallic taste or shortness of breath while on therapy. ASZ-l also has a distinct chemical smell. Because the Antineoplaston treatment will require prolonged administration by way of a central venous line, there is some likelihood of infection of that line and of phlebitis of the infused blood vessel.724 1. Patient G As noted above, after the first ANP infusion on experiencing dizziness, discomfort, and fatigue. headaches, and pressure. next day, Patient later, was Patient still Blood tests Two G reported September 12, days she reported having fatigue, later 2012, Patient showed she had abnormally low potassium levels. G reported having edema in both feet and increased blurred vision. Two days G reported that her Vision was getting worse, as present and worsened at night and with activities. were her headaches. The edema The next day, Patient G reported that her vision was getting worse and that her eye pain and headaches remained unchanged. 722 The FDA approves the protocols 723 Staff Ex. 31 at 20960. 724 The Staff Ex. 31 at 20959-20960. Staff Ex. 30 at 20174. to be used Protocol in each type of clinical BT-O9 appears In trial. to identify the same side effects from ANP treatment. SOAH DOCKET N O. 503-14-1342.MD response, Dr. Marquis increased her dosage of potassium and had no eye pain but said that she PAGE 148 PROPOSAL FOR DECISION ANP. On September had blurred vision in her still right 19, 2012, she eye together with agitation and increased anxiety. Dr. Marquis recommended that one type of ANP and the potassium be G was admitted to a hospital in her home city after waking up in the night with extreme leg pain. Subsequently, Patient G restarted ANP and her lower extremity pain returned. The edema increased as Patient G increased the ANP dosage over the next few days. Patient G discontinued treatment with ANP due to persistent edema. increased. Several days later Patient Dr. Wetmore testified Patient G experienced “significant side effects” from Respondent’s treatment that included edema, electrolyte disturbances, fungal growth in the mouth and on the skin, Dr. and extremity pain. Despite these side Wetmore tiredness, swelling, its list of known Based on the evidence, the ALJs find report serious, unknown line infection, However, as set side effects blurred vision, headache, fluid retention, electrolyte imbalance including decreased potassium, skin rash, and infection of the central venous find venous noted, Respondent did not report the adverse events, as required. forth above, the protocol included in dizziness, effects as well as a central line. that Protocol side effects causally related to BT-IO only required Respondent ANP treatment. to Consequently, the ALJs insufficient evidence that Respondent failed to report adverse events from Patient G’s ANP treatment with as required by Protocol BT-lO, and that Respondent violated 22 TAC § 200.3(7). 2. Patients I and J According to Dr. Wetmore, Respondent misrepresented that Patients no adverse events attributable to the ANP Patient I Wetmore and side effects constituted adverse events that was a 5-year-old boy from New York. had a brainstem lesion, although a and J experienced treatments because she noted that both patients experienced serious side effects. Respondent disagrees with Dr. unknown and unexpected I stated that only had to be reported. A November 2011 MRI revealed that he biopsy was not taken because of the lesion’s location. SOAH DOCKET NO. 503-14-1342.MD Patient I PAGE PROPOSAL FOR DECISION 149 was treated at a New York hospital with radiation concomitant with Zolinza (vorinostat) from November 4 until December When the 16, 2011. tumor’s size had increased, Patient 1 was treated with MRI showed that the February 16, 2012 chemotherapy that included the concurrent use of Temodar (temozolomide) and Zolinza from March 6 to April 1, The tumor 2012. continued to grow.725 Patient 1’s parents elected to discontinue traditional treatment and arrived at the Clinic April 30, 2012.726 According to the history and physical, was wheelchair-bound and somnolent. Although when Patient I on arrived at the Clinic, he the child could open his eyes, “his response could not be assessed” and he had “cushingoid features secondary to the steroids.”727 Patient began ANP treatment on May 7, 2012.728 Children’s Hospital and no further Patient 1 ANP On May 11, 2012, Patient 1 treatments were given to him. died of an intracranial hemorrhage located within the tumor.729 April 20, 2012 was admitted The On May into I Texas 14, 2012, Clinic only had the MRI taken to establish the baseline as required by the clinical study.730 That MRI was taken at the Long Island Jewish Medical Center. Patient J was a 4-year—old brainstem glioma.731 in South Africa. girl From August from South Africa whose August 2011 revealed a 31 to October 10, 2011, Patient J received radiation therapy The therapy appeared to have stabilized the disease, but two weeks before visiting the Clinic, the parents reported that Patient J’s condition the medical records, Patient J MRI was offered no had deteriorated. further treatment options. The April According to 13, MRI 2012 taken shortly before Patient J arrived at the Clinic showed that the mass had grown—measuring 725 Staff Ex. 54 at 41468. Respondent’s records indicate that the November 2011 MRI records were unavailable. 3.7 cm x 2.4 cm x 3.4 cm; on the February 16, 2012 MRI it The April 20, 2012 MRI of the tumor was reported as was 3.6 cm x 2.2 cm x 2.3 cm. StaffEx. 54 at 41556. 726 StaffEx. 54 at41469. 727 StaffEx. 54 72" StaffEx. 54 at41498. 7” at StaffEx. 54 at41474. 73° StaffEx. 54 7 StaffEx. 56.A 1.3 1 41469. at 41551, 41554. at 41731. . cm x 5.8 4.7 was Patient J treatment on cm.”2 Patient J ’5 parents brought their child to the Clinic on provisionally approved to receive ANP May 7, 2012. The child died on October After the patients began PAGE 150 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14-1342.MD ANP May 1, 2012.733 according to Protocol BT-lO and began 16, 2012. treatment, Dr. Wetmore noted, Patient I suffered the somnolence, Grade 2 hypokalemia requiring hospitalization, following adverse effects: ANP overdose.734 She also noted that Patient J experienced of appetite, CVC infection and hospitalization, Grade 2 anemia, lower vomiting, hypernatremia, and an fever, somnolence, loss extremity swelling, vomiting, diarrhea, Grade 2 hypernatremia, and Grade 2 hypokalemia.735 Contrary to Dr. Wetmore’s claim that Patients Respondent failed to properly report, I and J experienced adverse events that Respondent stressed the distinction between known and expected side effects and adverse events as defined in the FDA-approved protocol. that, effects Patients I unknown side effect causally related to the and J experienced, Respondent pointed they were either unrelated to experienced. These side effects were that Staff failed to prove that Patients 7” I out, at known side effects of StaffEx. 56.A at 41731. StaffEx. 68.03 at 127. 735 StaffEx. 68.03 at 127. 736 21 C.F.R. § 312.32(c)(1). 737 StaffExs. 53 at41, 650-51; 31 The side at 21071. side effects each patient ANP treatment. Respondent inaccurately reported 41731. 73“ treatment.736 were not adverse events because documented the and J experienced while receiving ANP treatments. StaffEx. 56.A ANP ANP treatment or were not unexpected.737 Patient 1’s and J’s respective medical records 7” explained according to the protocol for the clinical study, an adverse event had to be serious, unexpected, and an find He to Therefore, the BRI ALJs the adverse events SOAH DOCKET N O. 503-14-1342.MD In addition, Dr. PAGE 151 PROPOSAL FOR DECISION Wetmore opined imaging reports for Patient that the I had numerous inconsistencies and misrepresentations that were caused by Respondent’s failure to measure the from the same location and with the same type lesion consistently scan.738 She stated that: Dr. Burzynski did not measure the lesion consistently from the same location and type of scan; he did not consistently and accurately report in the medical record or to the family when the lesion was larger in size. Dr. Burzynski several times over-reported the initial size of the lesion. The lesion was clearly getting larger from January to April 2012 [and] while on antineoplastons, and yet Dr. Burzynski did not document this in the medical record or tell the family. Dr. Burzynski does not consistently compare enhancing and non-enhancing parts of the tumor, which represent very different parts of the tumor.739 According to Patient 1’s MRI, but ordered no Long medical records, Respondent received Patient other scans before Patient I mass had increased in size 2.3 . I I’s report from had a history of brainstem glioma and when compared Barry Shpizner, M.D., attending radiologist, Patient April 20, 2012 The April 20, 2012 radiology died. Island Jewish Medical Center reported that Patient that the soft tissue I’s to a prior exam. According tumor mass had increased from 3.5 to cm x cm x 3.4 cm to 3.7 cm X 2.4 cm X 4.1 cm and was “strongly suspicious for tumor progression .”740 Based on the April 20, 2012 radiology films from Long Island Jewish Medical Center, the Clinic’s baseline radiology report indicated that the brainstem enhancing mass was 3.7 cm x 2.4 cm.741 BRI-IRB provisionally approved Patient I to receive ANP as a special exception on May 2, 2012.742 Patient I started ANP treatment on May 7, 2012,743 discontinued ANP treatment on May 10, 2012,744 and was admitted into Texas Children’s Hospital on May 11, 2012. The 7” Staff Ex. 68.03 at 97-98. 739 Staff Ex. 68.03 at 97. sentence. 74° 7“ 7“ “3 7““ StaffEx. 54 at At the hearing, Dr. Wetmore testified 41554-41555. StaffEx. 54 at41551. StaffEx. 54 at 41633-41634. StaffEx. 54 at41484. StaffEx. 54 at41477. that the word “and” needed to be inserted into the child died on May 14, 2012, when the maintains that he properly reported that Patient Wetmore Patient I’s this information care. from Patient Patient Wetmore Dr. larger At I’s family. knew Patient I’s parents failed their child. I’s I the lesion did not also claimed that the documenting taken. unclear It is documented and informed the that Patient I York.746 Respondent medical record that in the to April 2012,” from January that time, Patient had grown and and for withholding was under another I become Respondent’s Dr. I was on ANP; ANP for three days and no other Wetmore concluded child’s parents that the had patient until April 30, 2012. tumor was getting larger while Patient how oncologist’s that traditional cancer treatment however, the medical record reflects that the child only received MRIS were New tumor measurement was not evaluable.747 faulted Respondent for not tumor was “clearly getting 152 tumor hemorrhaged.745 The only radiology scan taken during this time was the baseline scan taken on April 20, 2012, in Dr. PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD that Respondent should have tumor had gotten larger over the three days was on ANP. The ALJs find persuasive Respondent’s testimony taken while Patient I was treated with that no other radiologic scans were ANP because the child was only on ANP for a couple of days before he was admitted to the hospital and died. Contrary to Dr. Wetmore’s testimony, the medical records do not reflect that Respondent inaccurately or inconsistently measured the lesion because Patient I only had a baseline radiology report. As for Dr. Wetmore’s direct testimony of the lesion,” the records reflect that Respondent “several times over-reported the that Respondent’s measurements were consistent with those reported by Dr. Shpizner, the attending radiologist at Long initial size Island Jewish Medical Center. opined that the lesion grew from January to April 2012, treatment with ANP. record this in Patient 7“ 7‘” StaffEx. 54 at41474. StaffEx. 54 at41551. StaffEx. 54 at41550. was before Patient I even began Therefore, Staff incorrectly accused Respondent of failing to accurately I’s medical records. The preponderance of evidence does not support Staff 5 allegations that Respondent failed to protect Patient 7‘“ this While Dr. Wetmore correctly I in the clinical trial. SOAH DOCKET NO. 503-14-1342.MD Regarding Patient initial J, Dr. Wetmore accused Respondent of over-reporting tumor and improperly comparing MRI scans to CT The last had a stable disease Clinic’s that showed a decrease measurements of Patient in it J died on improper for Respondent to tumor tumor are dated from J’s size.748 May to August 2012. The measurement Respondent took was on August 24, 2012, and he reported Notes that the tumor was 4.5 November 10, 2011, cm x 4.4 cm. measured the tumor as “65 An 153 the size of the Because Patient images. October 30, 2012, due to the malignancy, Dr. Wetmore found report that Patient J PAGE PROPOSAL FOR DECISION Radiology in the outside radiologist’s findings taken on mm x 51 mm x 50 mm” (6.5 cm x. 5.1 cm x 5.0 cm).749 Respondent disputed the ANP that the Staff‘s claim that Respondent misclassified Patient most recent outside report before Patient radiology report taken while Patient J cm x response to treatment as “stable disease” with a decrease in tumor size. Respondent pointed out J April 13, 2012.750 At that time, the tumor measured 5 4.9 J’s 3.3 cm.752 Based on was still began treatment at the Clinic cm x 5cm X 4.7 cm.751 ANP The final outside under the Clinic’s care measured the tumor this outside radiology report, decreased in size while the child was on was from at Respondent asserted, the tumor had and his classification of “stable disease” was in compliance with the applicable protocol. According to Protocol BT-10, of a complete response, if the patient’s tumor response does not meet the definition partial response, or progressive disease, then it is considered a stable A complete response is defined as “the disappearance of all enhancing tumor on .”753 A neuroimaging studies such as MRI or ancillary radiologic studies of at least 4 weeks disease (SD). . 74* Staff Ex. VOl. at 74" StaffEx. 56 at 42130. 75" StaffEx. 56 at 42136. 75‘ StaffEx. 56 at 42136-42137. 752 StaffEx. 56 at 42132. StaffEx. 31 at 20952. 7” 99101. . . SOAH DOCKET N O. 503-14-1342.MD defined partial response is progression disease as a greater than or equal to a greater than or equal to is asserts that the patient did not have a 25% 50% reduction in the lesion and a Respondent increase in the lesion.754 50% reduction in the lesion and was properly reported as a “SD'99755 ‘ Although Dr. Fost discussed Patient testimony,756 could not when asked when at the J’s medical condition and treatment in his direct hearing about the type of cancer Patient I had, Dr. Fost said he Dr. Fost initially testified that Respondent had misclassified Patient J as recall.757 “stable,” but criteria PAGE 154 PROPOSAL FOR DECISION Dr. Fost reviewed the Response Assessment of Neuro-Oncology and the protocol definition of “stable,” (RANO) he conceded that Respondent had properly classified Patient J’s tumor.758 Based on the credible evidence, the ALJs find Patient’s J as “stable,” but evaluated the tumor that Respondent did not misclassify in compliance with Protocol BT-10. The evidence presented was insufficient to establish that Respondent measured the lesions inaccurately. Patient 3. On October “Children Clinic 15, N 2010, Patient N, a 4-year-old boy from Prague, Czech Republic, was taken to Ke Karlova” where an MRI revealed “an expansile enhanced with IV was not taken due contrast, necrotic 75“ StaffEx.31 at 20952. 755 StaffEx. 56 at 42128. 75" StaffEx. 68.01. 757 Tr. V01. 75" StaffEx. 68.01 759 StaffEx, 48 at38883. 76° StaffEx. 48 at38883. 1 at and cystic and compressing the fourth to the risk to the child. pontine glioma (DIPG).760 Patient V01. 1 Patient N was ventricle.”759 diagnosed as having a diffuse A biopsy intrinsic N was transferred to the neurology clinic at University Hospital in 238-239. at 66; Tr. lesion in the brainstem, partially at 247. Motol, Prague, and began radiation therapy on December treatments on 6, The 2010. Between February 12 and June 2011, taken on Patient May 6, PAGE 155 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD November post-radiation Patient 2, He completed 2010. MRI showed the radiation a decrease in the tumor size. N was treated with Temodar (chemotherapy). An MRI 2011, revealed that the tumor had progressed. The child’s parents discontinued N’s treatment with chemotherapy and brought Patient N to the Clinic on July 25, 2011. N Patient was ANP provisionally approved to receive patient under Protocol BT-lO. therapy as an expanded access According to the Patient N’s medical records, he began ANP treatments on July 29, 2011, and experienced frequent fevers, fatigue, night sweats, and diarrhea.761 Patient N continued taking ANP until October 7, 2011, when his mother Dr. Gregory Burzynski noted in the progress notes that Patient discontinued the treatment. N MRI taken on July 26, 2011, that revealed a brainstem glioma measuring 4.2 cm x 3.23 3.9 cm with a borderline prominent ventricular system.762 Patient N died on October 25, had an cm x 2011. Respondent reported that the tumor was “non evaluable.” According Respondent to Wetmore, Patient Dr. gait dysfunction, ANP, Patient suffered from numerous side effects that FDA. According failed to report to the being treated with N N to the medical records, she noted that while experienced somnolence, headaches, fever, slurred speech, hypokalemia, lower extremity swelling, lethargy, and vomiting. condition required hospitalization on September 28, 2011. imaging reports for Patient N She also opined 763 had numerous inconsistencies, misrepresentations, and were DIPG. She opined that the tumor was Respondent noted that the side StaffEx. 48 at 48883-48884. StaffEx. 48 at 38887, 39036. 763 StaffEx. 68.03 at 76“ StaffEx. 68.03 at 101; 765 effects Patient StaffEx. 31 at21071. As 128-129. StaffEx. 48 at N as having actually a “pilocytic astrocytoma.”764 events because none were unexpected.765 7“ N’s that Respondent’s missing documents. In Dr. Wetmore’s opinion, Respondent misdiagnosed Patient 76‘ Patient 39031-39039. N experienced were not reportable adverse for alleged misrepresentations in the radiology SOAH DOCKET NO. 503-14—1342.MD PAGE 156 PROPOSAL FOR DECISION Respondent asserted that Dr. Wetmore assigned the wrong baseline reports, because Patient time, Patient N to this patient N was only treated at the Clinic from August to September of 2011. During this had two MRIs, one dated July 27, 2011 and the other August 31, 2011.766 According to Respondent, the Clinic’s measurements taken on July 27 and August 31, 2011, were consistent with the outside radiology showed a marked decrease report in the reports.767 tumor size Although the Clinic’s second radiology of 16%,768 the Clinic still classified Patient N’s response as “non-evaluable,” rather than the more favorable “stable disease.”769 Dr. Wetmore testified that the “tumor enhancement, along with the cystic regions and tumor suggest septae within the Respondent disagreed that show how she a pilocytic astrocytoma and Clinic, Patient health care institutes, one of which to is NOT N was misdiagnosed, as Dr. Wetmore alleged. that Patient N came to the that before Patient it N’s diagnosis was confirmed was a neurology clinic. Dr. He emphasized at Wetmore provided arrived at her medical opinion that this patient had a DIPG.”770 two separate little support pilocytic astrocytoma and not DIPG. Patient N had been diagnosed by several physicians who treated the child before he came and to the Clinic ALJs find Patient all diagnosed him with DIPG.771 Based on the evidence in the record, the that Staff presented insufficient evidence to establish that N’s condition or that Respondent inaccurately reported the Respondent misdiagnosed results of Patient N’s imaging studies. Patient 4. According to received 767 7“ StaffEx. 48 at 0, a 63—year-old female, was an expanded access patient StaffEx. 48 StaffEx. 68.03 at Wetmore 39031. StaffEx. 48 at 39032. 77° Dr. 39031. at 101. See StaffEx. 48 at stated that who Respondent “did not measure the from the same location and type of scan; he did not consistently and Staff Ex. 48 at 39031 (clinic report), 769 7“ Staff, Patient ANP under Protocol BT-09. lesion consistently 7“ 0 39039. 39036 (outside report). SOAH DOCKET NO. 503—14-1342.MD PAGE 157 PROPOSAL FOR DECISION accurately report in the medical record or to the family when the lesion was larger in size. Dr. Burzynski several times over-reported the initial size of the lesion.”772 Contrary to Dr. Wetmore’s testimony that Patient investigation, ”773 not in a clinical or an expanded access patient, and did not receive trial carcinoma,”775 and “Orphan Drug designation 2012. ANP in a clinical made before Patient 0 therapy 0 was at the for the treatment of adrenocortical was treated with PB and targeted therapy. Under Respondent’s radiology measurement was May 29, was “involved or alternatively, in expanded access,774 Respondent stated that Patient Instead she had an Clinic. 0 direction, one arrived for treatment at the Clinic, on This measurement, Respondent pointed out, was similar to the outside radiologist’s findings.776 The Clinic’s medical records for Patient 0 indicate that she began PB treatments on February 13, 2012. She was also started on Gemzar (gemcitabine) with Xeloda (capecitabine) with the last infusion second time to of Gemzar given on April have Patient 0 3, 2012. On June 6, 2012, Respondent applied a approved to participate in an because standard cancer treatments had failed her. Patient began in 2006. ANP clinical trial (Protocol AD—2) 0 had an extensive cancer history that She came to the Clinic “seeking active treatment for her advancing metastatic adrenocortical carcinoma.”777 Although Respondent requested permission to treat Patient 0 with ANP under expanded access for single patient use, 778 there is no documentary evidence that this request was approved. In reaching her opinion that Respondent did not measure the lesion accurately, Dr. Wetmore appeared to be 772 StaffEx. 68.03 at 102-103. 773 Staff Ex. 68.03 at 102. 774 Staff’s Closing Argument at 775 StaffEx. 47 38753. 776 StaffEx. 68.03 777 StaffEx. 47 at38754. 778 StaffEx. 47 at at referring to the Clinic’s June 65. at 103. 38753, 38786. 1, 2012 Radiology Note regarding the PAGE 158 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD CT scan taken of Patient O’s chest, abdomen, and pelvis and the May 29, 2012 MD. Anderson’s CT scan report.779 The May 29, 2012 CT scan report from MD Anderson Cancer Center measured the lesion on the cm.780 3.8 The of liver right lobe at 3.8 Clinic’s Radiology notes indicated that x 3.6 cm, and the left at 6.5 X 3.5 on June 0 1, left at 6.9 x 5.8 2012, the right lesion measured at cm x 6.0 cm.781 The measurements were similar. Based on the credible evidence, the ALJs find to establish that Patient cm, and the one on the that Staff presented insufficient evidence participated in a clinical study or that she received ANP. Because 0 was not in a clinical trial, tumor measurements would not be subject to FDA protocol. if Patient 0 had been in a clinical trial, the evidentiary records does not support that Patient Even Respondent inaccurately measured Patient O’s 5. Patient P Patient P, a 57-year-old male, bones. He came P did not measure the type of scan for was diagnosed with multiple myeloma and compromised to the Clinic for treatment infection secondary to Revlimid.782 for Patient lesion. on April 30, 2012. This patient also had a herpes According to Dr. Wetmore, Respondent’s imaging reports lesion consistently from the same location or utilize the same comparisonm According to Patient P’s medical records, Patient P was not an expanded access patient who was treated with ANP and was not in a clinical Patient P be approved ANPs, the documentary evidence does not for treatment under received ANP'treatment. Staff Ex. 68.03 at 103. 78° StaffEx. 47 at 38830. 78‘ StaffEx. 47 at 38825-38826. 7“ 7“ StaffEx. 52 at 40630, 40634. StaffEx. 68.03 at 104; expanded access show that this What was approved was 779 StaffEx. 52 at 40636. study. Although Respondent requested for single-patient use request was approved that of intravenous or that Patient P the Clinic’s Statement of Informed Consent SOAH DOCKET N O. 503-14-1342.MD The for Investigation Clinical Study for this patient.784 show that Patient P participated find the evidence insufficient to study. in a clinical study or that show Because Patient P was not protect this patient in a clinical PAGE 159 PROPOSAL FOR DECISION that Respondent credible evidence presented does not he received ANP. Therefore, the ALJs failed to protect Patient in a clinical trial, Staff’s charge that trial is P in the clinical Respondent’s failed to misplaced. Patient S 6. Patient S, a 9—year-old boy, and enrolled in the Protocol was diagnosed with BT-lO clinical trial. July 19, 2002, to September 15, 2014.786 that Patient S’s disease On pilocytic astrocytoma, This patient was treated at the Clinic September 30, 2014, Respondent was SD, but changed his classification to PR WHO grade I785 initially from reported (partial response) on December 20, 2014. Staff asserts that Respondent improperly changed Patient S’s tumor response to the 787 treatment because Patient S’s disease had spread to his spine. FDA’s 2013 was PR BT-09 which prohibited corticosteroid use was in a patient with a in the Protocol BT-lO which did not have the same prohibition. Based on the evidentiary records, the are unclear for Dr. clinical study, But, Respondent’s records reflect that Patient S classification. ALJS on the inspection report and subsequent warning letter which represented that Patient S in the Protocol clinical trial Staff relied, in part, ANP which clinical study Patient Wetmore opined changes in the tumor tumor response size, that S was approved.788 Respondent did not accurately and consistently document but instead “skewed the results to to his investigation therapy when there was 78“ StaffEx. 52 7 an 5 StaffEx. 58.A 7 00 6 StaffEx. 68.03 at 133. 7’" StaffExs. 58 at 43373, 43375, 43377-43379, 43392-43393, 43408; 31 78" StaffExs. 58 at 42323; 65 Vol. 7 00 9 StaffEx. 68.03 at make 42361. at 109-111. 14. L09 at 46158-46159. at appear that there was a not.”789 40621. at it 20926. She also found that failed to report the severe side effects that Patient S experienced while being treated Respondent with PAGE 160 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD ANP, including two ANP overdoses, vomiting, diarrhea, persistent headaches, and fatigue.790 Respondent again pointed out that the side BT-10 and did not need side effects listed in Protocol maintained that Patient October 30, 2012, (1.2 x 1.3 S’s imaging For example, the misrepresentations. cm x effects these patients experienced 1.1 were reports slight increase to be reported.791 and consistent were known Respondent also did not contain of tumor size on the in-house report of cm) was consistent with outside report (1.2 cm x 1.5 cm); both reports indicated that there was a Slight increase in the size of the mass.792 The decreased size of the tumor measured on the January 23, 2013 in-house radiology note (1.2 1.1 cm cm) was also consistent with the outside radiology report (1.2 cm x .7 cm).793 cm x The in-house radiology note of July 24, 2013, showed a stable tumor size, but the outside radiology report actually showed that the tumor size had decreased.794 Dr. Burzynski explained that over the years the criteria for measuring changed three times, and McDonald criteria is about to change again.795 which required measuring the two tumor and then multiplying the measurements criteria is used to determine Dr. Burzynski said, it StaffExs. 68.03 at 133-134. 79‘ StaffEx. 31 7” at 20937, 20959-20960. StaffEx. 58 at 43403, 43406. 793 Staff Ex. 58 at 43397, 43400. 79“ Staff 13x. 58 at 43390, 43392. 795 StaffEx. 66.11 at 187-189. 796 Staff Ex. 66.JJ at 186. 797 StaffEx. 66.11 at 187—188. In the 1990s, the Clinic used the largest perpendicular diameters make a product.796 Currently, the of the RAND how to classify the disease. Each time the FDA changed the criteria, affected the 79° to tumor response has tumor measurements.797 PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD Based on the evidentiary record, the ALJs could not find that Respondent side effects that As 10. ANP for the attributable to were reportable overdoses, as adverse events under either Protocol it is BT-O9 ANP overdose and noted it in the progress notes.798 Respondent for each The ALJs find ANP, or skewed the of the tumor measurements. Patient 7. T Patient T, a 4-year—old boy, from February 11, at UCSF treated with ANP, diagnosed Wetmore side BT— failed to properly report the adverse events, engaged in misrepresenting Patient S’s response to Dr. or Protocol unclear that they were to be reported as an adverse event that Staff presented insufficient evidence to establish that results failed to report ANP. Respondent documented on the “Antineoplaston Overdose Report” time a patient reported an 161 was enrolled 2011 to March 26, 2014.799 BT—lO and was in Protocol Prior to Medical Center with a Grade 111 the patient had four separate coming treated at the Clinic to the clinic, the child anaplastic astrocytoma.800 ANP overdoses.801 this patient hypernatremia, diarrhea.802 experienced: somnolence, vomiting, all the following extreme dehydration, Staff also asserts that Respondent improperly characterized Patient T’s treatment response as SD.803 According to Dr. Wetmore, Respondent did not consistently measure Patient T’s tumors, did not accurately report in size, created reports that were based on missing contrary to outside radiology reports.804 79" StaffEx. 58 799 StaffEx. 68.03 80° StaffEx. 46 80‘ Staff Ex. 65, v. 14.L.09 at 46158-46159. 802 StaffEx. 68.03 803 StaffEx. 68.03 at 133. 80“ StaffEx. 68.03 at 111-113. at at 42323, 42446. at 135. 36256. at 135-137. While being These overdoses, opined, should have been reported as adverse events along with effects was MRI when the tumors had increased imaging, and created reports that were PAGE PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD 162 In addition, Staff maintains that Respondent failed to protect the safety and welfare of Patient T, because he did not provide adequate support and training to Patient T’s parents to properly operate the infusion pump, and Patient T as a result Patient pump. Patient T’s parents T experienced four on how had difficulty in operating Patient T’s ANP overdoses.805 experienced no serious adverse events as a result of the Respondent pointed out that ANP overdoses and that the overdoses were not side effects of ANP. They were caused by operator error.806 In support of its allegation, Staff referenced the 2013 letter. According to the report, despite widespread ANP FDA inspection report and warning overdoses, Respondent had not taken corrective action since 2003, had not trained the Clinic’s staff on had not reevaluated the in-house training program provided with Protocols BT-09, BT-10, BT-21, and BT how to address this issue, and to patients.807 The inspection 22, dealing with the study of ANP dealt on brain tumors.808 Notably, this report also states that the inspection did not reveal any evidence to support a lack of appropriate medical supervision; “did not reveal a failure of this clinical investigator to protect the right, safety, and welfare of subjects enrolled in a clinical study or receiving ANP treatment under an SPP/SPE;” and found “[n]o objectionable conditions or practices” regarding the delegation of study tasks to unlicensed or inappropriately trained physicians.809 Yet, Staff alleged that Respondent improperly delegated tasks to physicians and nonphysicians. As noted findings in in the this report documentary evidence, the Clinic had an opportunity and to any subsequent FDA warning letters. The to FDA respond to the is authorized to take further action, including terminating the clinical study or disqualifying the clinical 8O5 StaffExs. 46 at 36453, 65, VOl. 14.L.09 at 46159. 80“ StaffEx. 46 at36217. 8C7 StaffEx. 65, Vol. 14.L.o9 8 O8 StaffExs. 48 at 45917; 12 at 7149-7164. 8‘” StaffEx. 65, V01. 14.L.09 at at 46161-46162. 46092-46093. SOAH DOCKET NO. 503-14-1342.MD investigator, but there is no evidence record what final action, testify if and was not subject any, FDA has done 50.810 unclear in the evidentiary was taken by the FDA. Moreover, the FDA investigator did not Without flirther evidence, the ALJs find do not prove by a preponderance of the evidence failed to properly train Patient T’s parents Again Respondent noted 163 It is that the to cross-examination. the report and warning letter PAGE PROPOSAL FOR DECISION that that the Clinic on how to use the pump. that the side effects that Patient T experienced were known and not unexpected under Protocol BT-lO, and were not adverse events that required reporting.811 Respondent documented any ANP overdoses on the “Antineoplaston Overdose Report,” and the action taken.812 Although Dr. Wetmore claimed that Respondent had no measurements from an outside radiologist, the outside radiology report measurements is in the patient’s medical records that are very similar to the Clinic’s measurements.813 and contains Respondent agreed that the comparison of the Clinic’s baseline measurement of Patient T’s tumor in February to that referenced in the March used—5.8 cm x 4.4 cm the March increased, report, 814 report was done rather than the tumor would have been documented as that stable, rather in than slightly result. find that Staff presented insufficient evidence to establish that Respondent misrepresented Patient T’s response to mistake The wrong baseline measurements were 6.70m x 3.7 cm. Had the baseline been accurately reported which was a less favorable The ALJs in error. inured to ANP or skewed the results of the tumor measurements. A Respondent’s detriment does not constitute an intentional misrepresentation. 81° 21 C.F.R. § 312.70. The regulation affords the clinical investigator and the sponsor an opportunity for a regulatory hearing under part 16 of this chapter if there is a dispute with the FDA. 8“ StaffEx. 31 at 20937, 20959-60. 812 StaffExs. 46 at 36200, 36217, 36218, 36220 and 36453. 3‘3 StaffEx. 46 at 38408. 8‘4 StaffEx. 46 at 38394. SOAH DOCKET NO. 503—14-1342.MD Patient 8. PAGE 164 PROPOSAL FOR DECISION U U had stage IV adrenal cortical carcinoma and was enrolled in Protocol AD—02.815 According to Dr. Wetmore, Respondent treated Patient U from November 26, 2002, to August 8, 2009, during which time Patient U suffered side effects that Respondent underPatient the FDA.816 BRI-IRB and reported to These side effects, Dr. Wetmore opined, included hypertension, fatigue, dry mouth, nausea, vomiting, somnolence, headache, edema, joint pain, fever, chills, muscular pain, ANP ANP hypokalemia.817 Respondent argues that they were not caused by the much ANP.818 The CVC “caused” by ANP, CVC overdose, and grade 2 infections, hypernatremia, overdoses did not have to be reported because but by the patient mixing up the lines and giving himself too infection that Patient U experienced, Respondent pointed out, was not ANP and therefore did not need to be reported. The ALJs find that Staff presented insufficient evidence to establish that Respondent failed to report adverse events as required Respondent was required by the to report overdoses clinical study. It is unclear from the record that caused by operator errors as adverse events; therefore Staff failed to prove this allegation. Consent Forms 9. Staff alleges that the informed consent forms that the Clinic gave Patients T, V, Z, AA, and BB (in the Protocol BT-lO and BT-21 1, J, clinical trials)819 did not N, Q, R, S, comply with federal regulations because they failed to disclose the additional costs the patients were responsible for paying, as required by 21 C.F.R. § 50.25(b)(3).820 8 5 StaffEx. 29.3. 8 6 StaffEx. 68.03 .d ._. 8 7 ._. 8 8 8 9 82° Staff. Ex. 68.03 StaffEx. 39 Protocol 21 at at at 137. 27034, 27086. BT-lO CPR. 13722-1393. is Staff Ex. 31. Protocol § 50.25(b)(3) provides: BT-21 is in Staff Ex. 32. According to Staff, these SOAH DOCKET NO. 503-14-1342.MD patients only learned of these additional charges agreement laying out clinical trials. 821 when they were had consented their obligations after they them Respondent’s because clinical 13, 165 presented with a billing to participate in Respondent’s Staff presented no testimony from any of these patients or their families to verify that Respondent did not provide this information to December PAGE PROPOSAL FOR DECISION Staff trial. 2003 warning letter argues from the that FDA until they agreed to participate in Respondent received the about this issue, his failure to comply with federal regulations is a violation of Respondent’s ethical and professional responsibilities under the Code.822 Respondent pointed out that there 1,824 J ,825 N, 826 a signed informed consent form for Patients H,823 Q,827 R,828 8,829 T,830 V,831 2,832 AA,833 BB,834 participating in a clinical trial or as that the is FDA had approved. and Patient C0835 These patients expanded access patients signed the informed consent forms Respondent stressed that Staffs expert, Dr. Fost, candidly admitted of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject. (b) Additional elements (3) 82‘ Any additional costs to the subject that may result from participation StaffEx. 12 at 7157. 822 Staff Exs. 12 at 7157; 16 at 10139 (Warning Letter Item decided in Respondent’s favor in Order No. 7. 823 StaffEx. 53 82“ StaffEx. 54 at4l659. 8” StaffEx. 56 at at 41296, 41302. 42165, 42171. 826 Staff Ex. 48 at 39052-39057. 827 StaffEx. 42 at 33687. 82" StaffEx. 45 at 36076. 829 Staff Ex. 58 at 43494. 83° StaffEx. 46 at 38492. 83‘ StaffEx. 36 at 24729. StaffEx. 43 at 34308. 8” 8” in the research. StaffEx. 44 at 34948. 83“ StaffEx.41at32821. 835 StaffEx. 49 at 40132. 3); 65, v61. 14.L.09 at 46165. This issue was effectively SOAH DOCKET NO. 503—14-1342.MD PROPOSAL FOR DECISION he did not read Respondent’s informed consent form used in the read all studies,836 166 and had not of the protocols that he alleged Respondent violated.837 The the ANP PAGE ‘ FDA warning letter also gave Respondent 15 working days to file a letter advising FDA what Respondent intended to do to correct the informed consent or the FDA could take further regulatory action. whether the As previously discussed, it is unclear from the evidentiary record FDA imposed any sanctions. CPR. Moreover, 21 50.25(b) indicates that where appropriate the information § regarding additional costs must be included as an “additional” element of the informed consent. indicates that the informed consent statement provided to patients under The evidence presented a clinical study was submitted evidence presented clinical trial or is to the FDA and approved as part of the application process. The insufficient to establish that Respondent failed to protect the patients in a engaged in unprofessional associated with the clinical trial in conduct by failing to disclose all the additional costs the informed consent, particularly given that patients were given a written billing agreement before receiving treatment that explained the additional costs.838 Dr. Fost agreed that he does not believe “perfect compliance with possible, or necessarily desirable.”839 be found “in almost any large patients testified behalf. costs associated with being in a clinical must be included in the StaffEx. 6l.B.l 837 Tr, Vol. 83" StaffEx. 12 at7157. 839 StaffEx. 61.B.1 at 45133. 84° StaffEx. 61.B.1 at 45133. 1 at 45136. at 135:10-11. They trial. informed consent. 836 subjects” is He added that non—compliance with federal regulations can clinical research center.”840 on Respondent’s human all As discussed in Section XI, five agreed that they were aware of the additional The Board imposes no specific regulations on what SOAH DOCKET NO. 503-14-1342.MD PAGE 167 PROPOSAL FOR DECISION Based on the credible evidence, the Clinic’s patients knew before they received treatment in a clinical trial that the Clinic would charge was provided additional costs. This information a treatment billing agreement given to Clinic patients before treatment began. ALJS find that the credible evidence does not establish that patients in a clinical trial such that he engaged Respondent in unprofessional in Therefore, the failed to protect these and unethical conduct by failing to disclose additional costs related to a clinical trial in the informed consent process. Instead, the evidence showed that Respondent had this information provided to the patient or patient’s family agreement before treatment was provided. in the treatment billing B. Unethical Treatment of Patients Dr. Wetmore A Through F testified that Respondent did not responsibilities for Patients A meet and professional his ethical through F because he did not ensure that these patients fully understood the risks and benefits of the proposed treatments, that the risks were reasonable in relation to the anticipated benefits, patients.841 She opined that and that he had obtained adequate informed consent from the Respondent’s over-reading of radiological imaging was a violation of his ethical and professional responsibilities because he radiologist, he's not make an is “not a trained and licensed even a trained oncologist, and he doesn't have the training or experience to objective assessment of the lesion. He also has a conflict of interest because he gets financial reward from treating his patients and having that treatment be perceived as successful. So there’s Dr. (six) significant conflicts.” Fost testified responsibilities for Patients therapy research in a (2) way that 8‘42 Respondent did not meet his and professional ethical A through F because (1) he had a responsibility to do innovative that he and others could have learned from what they were doing, he had the responsibility to be extremely candid with the patients about the known benefits and risks of the drugs and combinations of drugs and to go patients were making informed choices about whether 8‘” Staff Ex. 68.03 at 89—90. 842 Tr. Vol. 6 at 98-99. to to special efforts to be involved, and make (3) sure that the he had a duty to SOAH DOCKET NO. 503—14-1342.MD practice medicine in a PAGE 168 PROPOSAL FOR DECISION way that involved honesty and disclosure and in which the personnel who were working with him were qualified and could be trusted to carry out the patients’ treatment in a responsible way.843 As noted above were all, in the discussions with the exception of Patient medications adjusted due To Patients of the individual patients, the records indicate that they D who was never treated, being monitored for, and their to, side effects. agree with Staff‘s allegation, the A-F were human subjects in ALJs first have to accept Staff’s proposition that non-FDA approved clinical trials. As pointed out by Respondent, these patients were private practice patients treated with targeted agents to which they consented. Respondent argues that the rules of clinical trials do not apply to these patients. Both the opinions of Dr. Wetmore and Dr. Fost are based on the assumption through F were subjects of clinical investigations. patients were seeking making adjustments alternative treatment However, the record to the alternative treatments of each patient, not performing non-FDA approved clinical investigator was in violation of 22 “3 84“ 8“ ANP I, StaffExs. 56 at 42150, 41252, 42165; 68.01 StaffEx. 50 8‘” StaffEx. 55 at41685. 848 StaffEx. 57 at 42273. at 40166. in fact human IRB approval before initiating treatment L845 K,846 L,847 M,848 N, O, and P,849 as required by “22 41263, 41265. 84" A through F were on H-P Without Proper BRI-IRB Approval Staff Ex. 68.01 at 23-24. at clinical trials TAC § 200.3(7). for Patients H,844 StaffEx. 53 of and Staff has failed to establish the Respondent Staff asserts that Respondent failed to obtain with effects Respondent was performing in the role of a when treating them. As a result, Treating Patients C. clinical trials or that A clear that these and Respondent was monitoring the them. Accordingly, Staff has failed to establish that Patients subjects in is that Patients at 62-66. TAC SOAH DOCKET NO. 503-14-1342.MD According to § 200.3(B).”850 Staff, these patients IRB member, Gary Harvey, who was As meaningless. were “provisionally approved” by one BRI- not a physician, and therefore his approval was a result, Respondent failed to get a meaningful safety review for these patients ANP treatment. By failing to do prior to initiating so, Staff contends, Respondent committed a serious breach of his ethical and professional responsibilities under 22 expanded access patients’ welfare, protect the PAGE 169 PROPOSAL FOR DECISION Respondent stressed safety, TAC § 201.3(7)(B) to and comfort. that Dr. Post only offered testimony concerning the Clinic’s treatment of Patient J on this issue. 851 Therefore, without any expert testimony or proof concerning the other patients, Respondent contends that the allegations regarding Patients H, I, K, L, M, N, O, and P should be disregarded. Respondent also pointed out that Patients K, L, M, O, and P did not receive ANP and were not enrolled in a clinical trial or approved as a special exception. Instead, as reflected in the medical record, these were private practice patients received PB and did not receive targeted therapy or no treatment at all from the Clinic. who Because these patients ANP, their treatment did not have to be approved by BRI-IRB. Therefore, Staff’s allegations regarding these patients are unsubstantiated.852 Respondent argues that because BRI—IRB does not engage in the practice of medicine,853 BRI-IRB’s actions are outside the Board’s jurisdiction, which of medicine.854 In addition, Respondent decisions to allow that neither Patient discussed in Section X(A). StaffEx. 52 85° 22 851 Staff Closing 852 Respondent’s Final Reply Brief at 2 l. 854 22 TAC 1 0 nor Patient P received treatment with that, ANP, as although Argument The ALJs believe Staff was referring to 22 TAC § 200.3(Z)(B). at 68. at 114. Board is “statutorily empowered to regulate the practice of medicine in Texas.” of Chiropractic Examiners v. Texas Med. Ass ’n, 375 S.W.3d 464, 466 (Tex. App—Austin, § 161. 1 (a) states that the See also Texas 2012). and, therefore, BRI—IRB’S 40621. TAC § 200.3(3) is not a proper citation. Tr. Vol. member of BRI-IRB Regarding Patients K, L, and M, the ALJs find “49 8” not a limited to regulating the practice him to treat these patients under a clinical study were made independently. The ALJs agree at is is Ba’. SOAH DOCKET NO. 503-14—1342.MD PAGE 170 PROPOSAL FOR DECISION Respondent requested that these patients be approved for treatment under a special exception or expanded access show for single patient use of intravenous that this request was approved or ANP, the documentary evidence does not ANP treatment.855 What was that the patients received approved was the Clinic’s Statement of Informed Consent for Investigation Clinical Study for these patients, none of failed to which were signed by the show that Patients K, L, M, patients.856 The credible evidence presented O and P participated in a clinical study or that they received ANP. In regards to Patients H, I, J, and N, before initiating treatment with IRB approval process. died on 3, May IRB gave 14, 2012. 2012.857 Patient on October 25, argument that Respondent failed to obtain ANP centers on federal requirements regarding the Patients I and N received provisional approval from IRB to receive ANP IRB approval treatments. Staff‘s Patient 1 provisional (expedited) approval The IRB board did not on May 2, 2012, but Patient grant full board approval to Patient I until I August N received provisional approval from BRI-IRB on June 28, 2011, and he died 2011. The IRB board did not grant Patient N final approval until January 27, 2012. Respondent pointed out presented insufficient evidence to show that that he is not a member of the IRB board. Staff Respondent directed or coerced the IRB board’s representative to grant the provisional approvals. These patients were seriously ill when they arrived at the Clinic. Staff‘s reasoning that because Respondent only received provisional approval from BRI-IRB to treat Patients H—J and N, he ethically breached his responsibilities under Board Rule 200.3 the exception of Patient N, the to treat Patients H, I, and J. is too far-reaching. With FDA also approved Respondent’s request for a special exception All these patients received detailed explanations of the treatment they would receive in the clinical study and signed an informed consent for the treatment. 8” StaffExs. 50, 55, 57. 856 StaffExs. so at 40167—40174; 52 857 StaffExs, 54 at 41633-41634, 41657-41658, 41694; 27 at 40621—40629; 57 at 42274-42281. at 17802; 12 at 7520. SOAH DOCKET NO. 503-14-1342.MD PAGE 171 PROPOSAL FOR DECISION Notably, even Staff’s expert Dr. Fost has criticized the FDA regulatory system as being “dysfunctional.”858 The ALJs find that Staff failed to present sufficient evidence to establish that had control over the IRB approval process or was responsible Therefore, the violated 22 ALJs find Respondent for the board’s activities. that Staff presented insufficient evidence to establish that Respondent TAC § 200.3. Inadequate/Inaccurate Reports of Therapeutic Response859 D. As a threshold issue, Respondent objects to any of Staffs arguments concerning Patients H and J regarding this issue because Staff did not include these allegations in its Complaint. The Complaint alleged that Respondent incorrectly reported the therapeutic response for Patients Q, R, V, W, X, Y, Z, AA, and BB, but Patient H and J were not included as part of this allegation.860 Therefore, the ALJs will not consider this allegation as it pertains to Patients Staff failed to provide proper notice of these claims as required § H and J because by the Texas Government Code 2001.052. Staff asserts that Respondent had a duty to utilize accepted standards of research as part of a competently designed program, to produce data that was scientifically valid and significant, and to protect the welfare of clinical 1 care in private practice.86 trial participants in the same manner Staff maintained that Respondent failed to professional responsibilities by misrepresenting tumor responses to 858 Tr. Vol, 1 at 148, 152, 153-154. In this article, as patients receiving meet these ANP and ethical failing to report Dr, Fost wrote: Over the past decade, the oversight of IRBs has been characterized by increasing requirements for meticulous documentation for compliance with narrow interpretations of regulations and policies, ofien with punitive sanctions, accompanied and perhaps exacerbated by a drumbeat of assertions that the regulatory system is broken. The source of these problems include institutions with draconian penalties for 859 According to 86° Complaint 8‘” 22 TAC OHRP minor Staff, this issue is applicable to Patients at 32; Staffs Closing Argument at 71. § 200.3(7)(A) and (B). and the FDA infractions. G and Q-BB. and because they appear to threaten SOAH DOCKET NO. 503-14-1342.MD PAGE 172 PROPOSAL FOR DECISION adverse events. In large part, Staff relied on the 2013 FDA inspection report and warning letter. In addition, the issue regarding adverse events has been discussed previously. Unless the side of ANP treatment was unknown, unexpected, and causally related to effect not need to report ANP, Respondent did it. Patient V862 1. Staff argues that Patient V, a child being treated at the Clinic under Protocol BT-lO, only obtained a partial response, not a complete response as Respondent reported. However, Staff ALJs cited no credible support find insufficient evidence to support Staff’s allegation that Respondent misrepresented this in the patient’s medical record for this position. Therefore, the patient’s response to treatment. Patient 2. Dr. R Wetmore questioned Respondent’s finding meaning complete response because, mass. in her opinion, the R experienced a “CR,” imaging showed a progressing tumor Staff also represented that Patient R’s July outside radiology report However, the report that Patient clinical records for Patient R admitted was missing. into evidence included the July radiology According to the outside radiologist, “complete from Innovative Radiology, PA. remission” was obtained on July 24, 2010.863 Dr. Wetmore somnolence, frequent hypokalemia.864 R ANP also opined that Patient vomiting, These were were expected and known side 862 three all side effects effects suffered numerous adverse events, including overdoses, and persistent headaches and included on the Informed Consent and therefore of this treatment. Accordingly, the ALJs find insufficient Staff Ex. 36 did not have any portion highlighted. In conformance with Order No. 34, if a party failed to highlight the relevant material in the documentation, it is deemed irrelevant. “3 86“ StaffEx. 45 at 35979. StaffEx. 68.03 at 131-133. SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 173 evidence to support Staffs allegations that Respondent misrepresented Patient R’s tumor response or failed to report the adverse events Patient R experienced while undergoing treatment. W 3. Patient Patient W was on Protocol BT—09 and was classified as having a CR, which requires the complete disappearance of all tumors for 4 or more weeks as long as the patient Although Staff maintains that Patient W did not meet the W’s medical high levels of corticosteroids, Patient Patient criteria Patient W’s clinical record in off steroids. because the patient was taking records in evidence do not reflect that W received corticosteroids within 4 weeks of Respondent’s evaluation.865 ALJs find is Therefore, the evidence does not support Staffs allegations that Respondent inaccurately reported the tumor response as CR. Similarly, the ALJs find Patient W’s medical tumors.866 unknown records in evidence do not establish that Respondent improperly measured the The side effects that Patient or unexpected. Therefore, the W experienced while being treated with ANP were not ALJs find the evidence is insufficient to establish that Respondent did not properly report them. Patient 4. Y Staff alleged that Patient Protocol BT-O9 because of her Y did not meet the criteria for corticosteroid use. evidence do not indicate what dosage, PR (partial response) However, Patient Y’s if any, the patient this patient’s clinical records in received of corticosteroid. Therefore, Staff presented insufficient information about corticosteroid use for the Respondent misrepresented under ALJs to find that tumor response. Although Staff asserts that Patient Y’s imaging reports were inconsistent or missing and that this patient experienced side effects that Respondent failed to report, Patient records reflect that Respondent relied upon an outside radiologist to “5 8“ StaffEx. 37. Staff Ex. 37. Y’s clinical confirm that Patient Y had a SOAH DOCKET NO. 503-14-1342.MD “partial response” to treatment.867 show that The ALJs find that Staff presented insufficient evidence to Respondent misrepresented Patient Y’s tumor response or events that Patient failed to report all adverse Y experienced. Patients Q, Z, 5. PAGE 174 PROPOSAL FOR DECISION Patients Q, Z, AA, and BB AA, and BB received classified by Respondent as SD.868 ANP treatment under Protocol BT-lO, and were Staff alleges that Respondent misclassified these patients’ response to treatment because they were using corticosteroids. Staff also maintains the imaging reports were “suspect, ”869 and had several ANP-attributed side to the IRB.870 Staff also asserted Patient Z’S Respondent under—reported that that these patients tumor was growing and Respondent incorrectly included a period when Patient Z had a tumor resection the patient Patient was SD. Finally, Staff questioned the propriety AA’S adverse event (death) to a Grade 4 from taking to determine of changing the grading of associated with her death on August 31, 2009, from a Grade 5 (life threatening). In evaluating a tumor’s response to treatment, Protocol patient effects that The steroids. BT—lO does not prohibit the RAND criteria, however, restricts steroid use to either stable or decreasing amounts. Patient Q’s records indicate that the patient received Decadron usually at .5 mg PO However, the evidence q.i.d.871 acceptable under the RANO criteria. sufficient credible evidence to classifying Patient “7 8“ show is unclear what amount of Decadron would be Therefore, the that ALJS find that Staff failed to provide Respondent used corticosteroids improperly when Q under Protocol BT—10. Staff Ex. Vol. 38 at 26759. Staff Ex. 31 at 20952-20953. The clinical records for Patient AA is Staff Ex. 44; and Patient BB is Staff Ex. 41. 869 Staff‘s Closing 87° StaffEx. 68.03 at 130-131. 871 StaffEx. 42 at Argument at Q is Staff Ex. 42; Patient 2 is Staff Ex. 43; Patient 70. 32958-59, 32942, 32939, 32938, 32937, 32924, 32922, 32921, 32911, 32907, 32905, As for Respondent’s that PAGE 175 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD radiology reports included in Patient Q’s progress notes, evident it is Respondent’s measurements are inconsistent with the outside radiologist’s. The following reflect the measurements taken of the brainstem non—enhancing mass. The Date Respondent872 Outside Radiologist 11/14/08 2.5x 3.0x 1.8x2.9 01/07/09 2.5 x 1.5 Not Present 03/13/09 2.5 X Not Present 04/20/09 2.5 x1.5 06/18/09 2.8x 07/24/09 3 substantial differences x 1.5 1.5 3.6 x 3.4 x 873 2.1 5.2x3.0x4.1 1.6 5.2 x 3.4 1.8 x 4.5 between the outside radiologist’s measurements and Respondent’s measurements were not reasonably explained. Therefore, the ALJs find that Staff proved by a preponderance of the evidence that Respondent inaccurately reported Patient Q’s tumor’s measurements causing the classification of the tumor’s response Patient Z, a teenage girl with brain cancer, to May June 18, was 2009. She previously had undergone a 2008, a MRI taken at Nationwide the size of the recurrent mass. to treatment to treated at the Clinic be in error. from December 2008 right parietal occipital craniotomy.874 On Children’s Hospital showed a significant increase in The mass measured 2.7 cm x 2.1 cm x 2.0 cm.875 Another tumor MRI was taken in December 2008 before the patient came to the Clinic. At that time the tumor measured 4.7 cm X 3.4 cm x 3.7 cm, indicating another Significant increase in the tumor Size. . . . 872 StaffEx. 42 at 33615, 32940, 32927, 32917, 32908, 32901. 873 StaffEx. 42 at 33616-33622, 33625-26. 87“ StaffEx. 43 at 34229. 875 StaffEx. 43 at 34299. 876 StaffEx. 43 at 34223. . . . . . SOAH DOCKET NO. 503-14-1342.MD On January 15, 2009, Patient Z’s cm tumor measured 4.7 x 3.5 cm x MRI 3.7.877 taken by an outside radiologist revealed that the Respondent measured the mass as 4 x outside radiologist reported that the February 19, 2009 x 4.0 cm x 4.8 cm, and found PAGE 176 PROPOSAL FOR DECISION that the 4.7.878 MRI measured the tumor mass mass had increased as 4.1 The cm slightly in the medial to lateral dimension, but had no appreciable change in the anterior, posterior, or superior to inferior dimensions.879 Respondent measured the tumor at 4 x 4.7.880 that the mass measured was x 5 3.882 Patient 4.3 clinical trial Protocol 5.6 Z cm x 4.2 cm x 4.5 2, 2009 MRI cm.881 Respondent reported that the underwent a craniotomy in BT-IO by June 4, The April late May reported tumor mass and was discontinued from the 2009.883 Despite Staff’s claim that Respondent took credit for the reduction in tumor size based on the May 2009 comment craniotomy, Respondent’s report regarding the tumor measurements stated in the section May 27, 2009.”884 documented that “[t]he patient underwent craniotomy with tumor debulking on In the patient’s progress notes regarding the July that the patient’s “[r]ight occipitoparietal 2009 MRIs, Respondent enhancing lesions were surgically removed” and that the MRIs were post-operative. As discussed before, Protocol BT—lO required that the investigator document the tumor’s response to treatment as either a complete response (CR), a partial response (PR), or a progressive disease (PD). All other situations were considered stable disease.885 Based on the medical record in evidence, Respondent properly recorded the tumor response as “stable disease” 877 StaffEx. 43 at 34217. 87* StaffEx. 43 at 34203. 879 StaffEx. 43 at 34215. 83° StaffEx. 43 at 34203. 8*“ StaffEx. 43 at 34209. StaffEx. 43 at 34203. “2 883 StaffEx. 43 at33815. 88“ StaffEx. 43 885 Staff Ex. 31 at 20952-20953. at 33754, 33812, 34204. SOAH DOCKET NO. 503-14-1342.MD PROPOSAL FOR DECISION because the tumor had not increased in size at least 25%. The medical records Respondent’s tumor measurements for Patient in conformance with protocol for the into evidence, the Patient Z’s (stable disease) Staff, Based on the medical records admitted show that Respondent AA stating that he saw Patient deterioration. 93887 Respondent mischaracterized Patient AA’s response died. On September 8, 2009, Dr. Jose Eguiguren sent Dr. Weaver an email According to Dr. Eguiguren, the cause of death to decrease mobility due Clinic initially reported that the severity of the event 14, 2014 to life-threatening. It is to was may have been due significant reason for such a change in Patient after death, but Respondent changed AA’s medical 19, 2007, Patient response to “non evaluable” on October 22, 2014, because it Why Respondent almost five years.889 records, the Respondent improperly changed the severity of the adverse event from death to Respondent reported that on July to “a weight gain due to Decadron.”888 unclear from the medical record changed the severity of Patient AA’s adverse event Without a ALJs find that life-threatening. BB was “SD,” but he changed the Patient BB was on high dosages of Based on Respondent’s re-evaluation, the ALJs find steroids.890 to treatment as AA on August 26, 2009, and that there was evidence of “neurologic pulmonary embolism secondary on January inaccurately reported and improperly changed the grading of the adverse event that occurred the day Patient The to similar to the outside radiologist’s tumor measurements or the response to treatment. According to SD Z were clinical study. ALJs find insufficient evidence also reflect that Z experienced while on treatment.886 the Clinic kept records of the adverse event that Patient and PAGE 177 that the original misclassification was inaccurate, but that the evidence does not establish that Respondent intentionally misrepresented that Patient 8“ StaffEx. 43 at 33767-33770. 8‘” StaffEx. 44 at 34424. 88* StaffEx. 44 at 34424. “89 StaffEx. 44 at 34350. 89° Staff Ex. 41 at 32794, 32796. BB was SD. SOAH DOCKET NO. 503-14-1342.MD Patient 6. X X was treated under Protocol BT-21. Although Respondent classified Patient X he kept Patient X on fluctuating levels of corticosteroids. The criteria for a Patient as being CR, therapeutic response required a “complete disappearance of neuroimaging Patient is time, Dr. The studies, and ancillary radiographic studies off corticosteroids.”891 on September 5, 2005.892 The clinical records in later. Patient X was on contrast enhancing progress note in evidence the dose of ALJs find that tumor on 4 weeks or longer. if appropriate for X had a CR to the treatment was from April 1, 2005. At that Decadron the patient had previously been evidence do not show that Patient Therefore, the all Respondent reported that Patient last Weaver was decreasing months PAGE 178 PROPOSAL FOR DECISION X was on any taking. corticosteroids five Staff presented insufficient evidence to establish that corticosteroids at or near 4 weeks before Respondent reported the tumor response.893 Staff also asserts that Respondent mischaracterized Patient X’s he incorrectly based the CR classification on PET tumor response because scan results and not on the showed tumor progression.”4 However, a review of the outside radiology closely to Respondent’s tumor measurements.895 Based on the MRI results that reports correlates clinical records, the ALJs find insufficient evidence to establish that Respondent improperly measured Patient X’s tumor or improperly reported the therapeutic response to treatment as CR. This patient also experienced numerous side effects, including one However, the ALJs find that Staff provided insufficient evidence to to report these side effects experienced StaffEx. 32 at21876. 8 \D 2 StaffEx. 40 at 32289. 8 \O 3 StaffEx. 40 at 31742. 89“ StaffExs. 65, v. 14.L.09 at 46138-46140; 68:03 at 116-118. 395 Staff Ex. 40. 8 \D 6 StaffEx. 68.03 at 141-142. overdose.896 show that Respondent by Patient X as adverse events. 89‘ ANP failed PAGE 179 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14-1342.MD Inadequately Training Subordinates About Adverse Events897 E. Staff maintained that, between February 2001 and July of 2012, 11 patients experienced ANP overdoses due to mistakes made by the patient or the patient’s parents or from Staff contends that Respondent failed to adequately implement a patient malfunctioning. program or retraining that pumps Respondent to train and retrain his subordinates adequately. In addition, Staff argues failed to train his subordinates about adverse events. Respondent contends that those involved in clinical trials at the Clinic were adequately trained to report adverse events. Anita Shrout, a physician assistant at the Clinic, testified that she was trained to, and understood that she was to, document and grade any adverse events that a patient experienced in the patient’s medical records in accordance with the proper protocol for the clinical study. Then she would discuss the event with the patient’s physician.898 Barbara Szymkowski, a research associate understood duty the to report adverse at the Clinic, likewise indicated that events “to the investigator right she away.”899 Marilyn Threlkeld testified that unless the physician or patient requested otherwise, she called the ANP patients daily to discuss their conditions.900 be called at a minimum of once immediately involved.901 a week and if they Dr. Marquis confirmed that patients reported any complications, a physician Drs. Burzynski and Marquis affirmed required to report any serious adverse events related to the According to 89" StaffEx. 899 StaffEx. 66.] at 14. 90° StaffEx. 66.K 9°‘ Tr. Vol. 13 at37-39. 902 Tr. Vol. 13 at 46; StaffEx. 66.11 at 145-146. 903 Staff Ex. Staff, this issue is applicable to Patients 66M at 5—6. at 8-9. 66.06 at 201-202. ANP treatment.903 G and Q through U. to was that they understood their obligation to report adverse events.902 Dr. Gregory Burzynski also testified that he 897 had knew he was SOAH DOCKET NO. 503-14-1342.MD The ALJS find PAGE 180 PROPOSAL FOR DECISION that Staff presented insufficient evidence to establish that Respondent failed to adequately training his subordinates about adverse events. Staff claims that Respondent failed to retrain the Clinic staff and patients after an overdose, but Respondent pointed out that the overdose reports document that after any overdose, the patient or the patient’s parents were retraine d.904 because the person operating the pump was Many ANP ANP overdoses occurred tired or confused, not that they did not know how to properly operate the pump. In addition to the in-clinic training, Respondent pointed out that each patient on ANP was given a 63—page packet of information on administering ANP.905 Based on the credible evidence, the ALJs find insufficient credible evidence to prove Respondent failed to properly train or retrain the patients, their family, or the staff that on proper pump use. and Report the Effect of Corticosteroids Failing to Properly Consider F. Treatment in Patient G’s Staff alleges that Respondent failed to ensure that the protocols were followed to isolate the impact of corticosteroids on tumor response. Staff argues that by prescribing high and fluctuating levels of steroids to Patient G, Respondent failed to follow the steroid use with imaging ANP, and did not take Patient G’s steroid use into account Wetmore interpreting G and her mother about ANP. She stated that the persistent use of corticosteroids also complicated the interpretation of the change the way a tumor looks on misinterpretation of the 905 when testified that Respondent failed to caution Patient the concurrent use of steroids and the continued course of See, (“patient guidelines for results. Dr. 904 BT-09 e. g., was MRI MRI with no other intervention. results because She opined it can that this images caused the accurate tumor response to be repeatedly Staff Exs. 46 at 36217 (“father retrained on proper tubing use”). Staff Ex. 60 at 44298-44360, MRI was retrained”); 45 at 35071 (“Mother was retrained”); 39 at 27034 SOAH DOCKET NO. 503—14-1342.MD PAGE PROPOSAL FOR DECISION misrepresented to Patient G’s mother. Wetmore Dr. testified that she saw no indication in the records that the Clinic considered the contribution of the effect that the corticosteroids MRI had on interpretation of the properly attribute all may have In addition, she stated that Respondent, as a physician scans. involved in a clinical investigation of 181 ANP, needed to be absolutely certain to document and of the adverse events so that there was no confusion about What might have been or not have been attributable interpret the data so as to sway the He to the medication. outcome of the study. Dr. Burzynski testified that taking of steroids is had also to be very careful not to 906 common for persons with brain tumors because they can temporarily decrease the swelling around the tumor and make the patients more comfortable. He swelling of the stated that a typical side effect of steroids is abdomen and attributable to her taking legs, and, in his opinion, Patient fluid retention manifested as G’s edema and weight gain were of the steroids and not from the ANP, which usually is accompanied by fluid loss rather than retention. 907 In regard to the effect of steroids it was not known if steroids tumor had disappeared Cancer a of the the it amount necessary was proven StaffEx. 68.01 9‘” Tr. v61. 7 at 293-295. 90" Tr. Vol. 8 2112939. at 88; Tr. of 1993, to a treatment RANO that permitted the use of steroids Under this new definition, the dosage of to provide neurological stability basis. Dr. v61. 6 at 159-162. where in 2012, the National of the symptoms, Burzynski explained that this change was that while steroids cannot shrink the tumor, they edema around the tumor. 908 906 However, beginning called patients. which must be determined on an individual implemented because had been a complete response new classification to maintain neurological stability steroids is limited to the if there for a period of four weeks. Institute established that, as might cause shrinkage of a tumor, so patients were required to be completely off steroids to determine the on tumor growth, Dr. Burzynski noted can shrink Respondent points out PAGE 182 PROPOSAL FOR DECISION SOAH DOCKET NO. 503-14-1342.MD that Protocol BT-09 for the Phase II study of the use of ANP for the treatment of patients with brain tumors provides that the use of any steroids concomitant with ANP does not render the patient ineligible for the study but must be documented, and that the use of corticosteroids is permitted to reduce symptoms and signs attributed to cerebral edema. 909 Protocol BT-21 repeats these statements.910 The medical records consistently discuss the fact that Patient steroids during her treatments with attributed to her use off the steroids. ANP, and even G was continuing to use discussed the side effects that could be of steroids. During the course of treatment, Respondent sought to wean her Clearly Respondent took Patient G’s use of steroids into account when determining her treatment. Respondent has pointed to nothing in the record that states that the effect of the steroids on the MRI scans was considered by Clinic personnel interpreting the scans that indicated an increase in the size of the tumor. Dr. Burzynski’s testimony, the effect of steroids and not on the tumor itself. determining whether a tumor failed to establish that on the G. interpretation As is would be on the when they were However, based on edema surrounding the tumor a result, the effect of the steroids should not have an effect on increasing or decreasing. Accordingly, the ALJs find Respondent ignored the impact of the corticosteroids Patient that Staff G was taking of the MRI. Failing to Inform Patient G of Additional Costs Staff alleges that the informed consent forms in the single patient protocol failed to adequately inform Patient G of additional costs she might incur in her treatment. In a Warning Letter dated December 3, 2013, Thomas N. Moreno things, that the informed consent forms for the patients included in the stated, Phase among II clinical other study of ANP did not contain a statement regarding any additional costs to the subject that may result in participating in the research 909 StaffEx. 30 91" StaffEx. 32 at 21843, 21851. at 20185, 20191. and that the subjects were presented with a billing statement only SOAH DOCKET N O. 503-14-1342.MD after PAGE PROPOSAL FOR DECISION 183 they had consented to participate in the research, thereby denying them the opportunity to make an informed letter, decision regarding their participation in the study.911 July 1, 2014, in a Sean Y. Kassim, Acting Director of the Office of Scientific Investigations of the Office of Compliance of the Center Drug Evaluation and Research of for certain of the items noted in the . On . 1nclud1ng the December mformed consent correctlve . . Warning Letter 3 . actlon, FDA, stated that while needed correction, other items, still were adequate.9 the l 2 Staff argues that this two-part consent process, consenting to the research and then being presented with the costs, did not allow Patient whether to participate in the about all the financial obligations at the time she According under 22 to make a fully informed decision about Staff asserts that she should have been informed clinical study. already agreed to participate. G was considering treatment, not after she had to Staff, this two-part consent process is inadequate TAC § 200.3(7)(C). The Treatment Agreement signed by Billing Patient G on August 31, 2012, her first day at the Clinic, sets forth the initial consultation fees; laboratory testing fees; regimen of evaluation, daily patient assessment, review of diagnostic treatment analysis, follow-up supplies; IV medication visits, a deposit to tests, start the regimen plan and telephone conferences, IV instruction and necessary medical fees; a deposit for the IV pump; and a monthly deposit for case management.913 Patient G was presented with the costs of treatment on August 31, 2012. Approval for G to participate in the single patient protocol was given on September 6, 2012. The first infusion of ANP was made on September 12, 2012. Clearly, Patient G was informed of all the Patient costs involved in her treatment before she failed to establish that 9“ 9‘2 9” Respondent violated 22 StaffEx. 12 at 7149-7164. StaffEx. 16 at 10106-10130. StaffEx. began receiving the ANP. Accordingly, Staff has 7.06M at 3522 — 3525. TAC § 200.3(7)(C) in regard to Patient G. SOAH DOCKET NO. 503-14—1342.MD PAGE 184 PROPOSAL FOR DECISION Inadequate and Inaccurate Patient CC’s Case History H. This allegation actually involves Patient DD Patient was not included DD but the Complaint referred to Patient C0914 in Staff’s allegations. Staff recognized that Respondent proper notice of a claim concerning Patient DD. Pursuant Code to it failed to provide Texas Government 2001.052, the ALJs find Staff failed to give Respondent proper notice of this claim, and § therefore it will not be considered. Violations of Federal Regulations as Clinical Investigator 1. According to Staff, Respondent engaged in unprofessional by committing likely to deceive or defraud the public and dishonorable conduct acts that violate state or federal laws connected with Respondent’s practice of medicine;915 failing to conduct clinical investigations that were competently designed as part of a systematic program under accepted standards of scientific research with the aim being by Violating federal regulations to produce scientifically valid and significant data; that protected the health and governed the administration of clinical Respondent agrees that the trials for FDA pharmaceuticals. issued preliminary findings that certain federal were resolved. Dr. Burzynski testified any issues that the FDA is not possible.918 Violations in some form Complaint 9‘5 Code 164.053(a)(1). 916 Code l64.051(a)(3), regarding violations 9‘7 . . . Tr. Vol. FDA inquiries until the measures to fix and correct December 3, or fashion almost always occur. 2013 Warning FDA regulations Staff presented no Section III.C.20.v.12.a, of22 TAC § 200.3(7). (“[We] responded to every one of the [FDA] allegations and we took immediate correction [including] implementing changes in the protocol and implementing changes in the standard operating procedure and preparing 9‘8 that he took remedial Tr. Vol. 9 at 181 action of the even confirmed that perfect compliance with 9‘4 at all had, including the issues raised in the Letter.917 Staff’s expert, Dr. Fost, and and safety of human research subjects regulations were violated, but emphasized that he responded to issues 916 1 at 186. new standard operating procedure”). SOAH DOCKET NO. 503-14-1342.MD evidence to show that the study. FDA has taken any final action against Respondent Respondent continues Respondent violated his XI. or terminated the to serve as the principal investigator for these clinical trials. Based on the evidence presented that PAGE 185 PROPOSAL FOR DECISION ethical duty in this hearing, the ALJs find that Staff failed to and responsibilities as a clinical show investigator. AGGRAVATING AND MITIGATING FACTORS Aggravating Factors A. Board Rule 190.15(b) more severe or factors that warrant patients; (2) the severity economic patient; (4) states that the following factors restrictive action may be by the Board: considered as aggravating (1) harm one or more to of patient harm; (3) one or more violations that involve more than one harm to any individual or entity and the severity of such harm; (5) increased potential for harm to the public; (6) attempted concealment of the act constituting a violation; (7) intentional, premeditated, knowing, or grossly negligent act by the constituting a Violation; (8) prior similar violations; (9) previous disciplinary action Board, any government agency, peer review organization, or health care entity; (10) violation of a Board order; and (11) other relevant circumstances increasing the seriousness of the misconduct. Staff argues that the aggravating factors relevant in this proceeding include or more patient, patients, the severity economic harm prior similar violations, any individual or harm records; (2) there is one entity, increased potential for harm to the public, and previous disciplinary action by the Board. indicated above, (1) there suffered actual to of patient harm, one or more violations that involve more than one Severity of harm, harm to one or more patients, and one or that involve more than one patient 1. As to harm to their health is more violations insufficient evidence that any of Respondent’s patients by a violation of the standard of care or having inadequate insufficient evidence that any of Respondent’s patients were actually harmed SOAH DOCKET NO. 503-14—1342.MD by his failure to ensure that RAs Rakhmanov, Tikhomirova, and Acelar did not directly or were authorized indirectly represent to the public that they to practice medicine, (3) there is insufficient evidence that any of Respondent’s patients were actually RA Acelar to practice medicine without a license; and harmed by (4) there is insufficient any of Respondent’s patients were economically harmed by his interest in the pharmacies; PAGE 186 PROPOSAL FOR DECISION his allowing evidence to show that failure to disclose his (5) there is insufficient evidence that were economically harmed by having inadequate medical records ownership any of Respondent’s patients to support Clinic charges. addition, Respondent’s failure to obtain timely and/or adequate informed consents involved than one patient: Patients As more A through C and B through G. Increased potential for 2. In harm to the public discussed above, unless corrected for the future, the following actions by Respondent could represent potential harm to the public: (1) failing to ensure that research associates did not directly or indirectly represent to the public that they (2) allowing a research associate to practice ownership interest in the pharmacies; and were authorized to practice medicine, medicine without a license; (3) failing to disclose his (4) failing to have adequate medical records to support Clinic charges. 3. Prior similar violations and previous disciplinary action by the Board On August 31, 1994, the Board suspended Respondent’s license for a period of ten years, but probated the suspension. with The basis of the action was that Respondent had treated patients ANP in violation of the laws in effect at that time and had made false advertisements ANP. The As order was upheld by the Third Court of Appeals on February discussed above, Respondent did not treat patients with in effect during the time period covered advertisements about by this 7, about 1996. ANP in violation of the laws Proposal for Decision and did not make ANP during the time period covered by this Proposal for Decision. false SOAH DOCKET NO. 503—14-1342.MD PAGE 187 PROPOSAL FOR DECISION Mitigating Factors B. Board Rule 190.15(b) states that the following factors may (1) self-reporting or voluntary factors that warrant less severe or restrictive disciplinary action: admission of violation; by a violation; (2) be considered as mitigating implementing remedial measures to correct or mitigate harm caused wrongdoing and willingness (3) admitting (4) rehabilitative potential; (5) prior community to cooperate with the Board; service and present value to the community; medical education, (7) other relevant circumstances reducing the (6) participating in continuing seriousness of the misconduct; and (8) other relevant circumstances lessening the physicians responsibility for the misconduct. Mitigating factors relevant in this proceeding include Respondent’s rehabilitative potential, his present value to the community of terminally ill cancer patients, and his contribution to the advancement of cancer research. 1. Rehabilitative Potential Respondent has devoted his career as a physician endeavor, he worked Cancer Institute (N CI) at who finding a cure for cancer. In that Baylor College of Medicine and received funding from the National to research the link Respondent opened the Clinic patients to in 1977, between peptides in blood and cancer growth. After he focused on treating terminally ill cancer patients, those either chose not to try traditional cancer treatment or tried conventional cancer treatment and were not cured. In 1990, Respondent began providing what has since become known as personalized therapy to treat the cause of the cancer. FDA approved ANP that time, the FDA has Respondent discovered and patented a new drug, ANP. In 1993, the for a clinical trial with Respondent serving as the approved approximately 65 prospective Respondent serving as the principal 9‘9 Tr. Vol. 7 at 63. investigator. clinical trials investigator.919 Since and one retrospective clinic trial with SOAH DOCKET NO. 503-14-1342.MD It is uncommon for a person who has discovered an investigational drug to be clinical trials without the financial support to Dr. Levin, on some to proceed to phase III trials. 921 II Using targeted agents in of the combination is FDA trials and the FDA has given permission In Dr. Levin’s opinion, Respondent pioneer.” Because of Respondent’s research on now acceptance able to run of a pharmaceutical company or NCI.920 According Respondent has completed phase stated that “there is PAGE 188 PROPOSAL FOR DECISION ANP and fact that these its is a “medical analogues such as PB, Dr. Levin compounds have anti-cancer activity.” a therapeutic leap.922 Dr. Levin stated: Dr. Burzynski should be credited for discovering a family of compounds which have shown anti-cancer activity and have had impressive results in patients treated in clinical trials, at least in the parameter in having long—term survivors in brain tumors where surviving the disease is relatively uncommon.923 Based on the evidence, the ALJs find physician who wants the investigator in to continue treating ANP clinical trials committed are not so severe Respondent has 2. that Respondent is a dedicated and innovative advanced cancer patients and to continue to serve as approved by the FDA. The violations that Respondent that they are not rectifiable. Therefore, the ALJs find that rehabilitative potential. Prior Service and Present Value to Patients924 Respondent’s practice was and who have unfavorable is Community of Terminally predominantly treating terminally prognoses. Several patients traveled at their ill Ill Cancer cancer patients own expense to testify on his behalf. 92° Resp. BX. 165; StaffEx. 168.01 at 92‘ Resp. Ex. 165 at71. 922 Resp. Ex. 165 at 70, 72. 923 Resp. BX. 165 at 70. 924 8. The ALJs requested that Respondent only call a few of his former patients to testify. However, several of Respondent’s former patients and their families appeared at the hearing to support him. SOAH DOCKET NO. 503-14-1342.MD Ms. Manning was 53 years old cell PAGE 189 PROPOSAL FOR DECISION 2009 when she was diagnosed with stage IV mantle in non-Hodgkin’s lymphoma. Her oncologist in Arizona told her that no one with this disease, and “strongest chemo she did nothing, she would die in a year. However, if she underwent the in the hospital and bone marrow — bone marrow transplant twice,” she might Ms. Manning sought a second opinion from physicians live three years.925 Arizona and if very long lives at the University MD. Anderson Cancer Center and was give the same prognosis. of She explained that she decided against this course of treatment because even after enduring chemotherapy and the bone marrow been sick or transplants, she would only live three years, and most of that time she would have in the hospital. According to Ms. Manning, she and her family began investigating alternative treatments. Ultimately, after conferring with the mother of one of Respondent’s patients, Ms. elected to be treated by Respondent. Ms. Manning began treatment at the Clinic in April This treatment, she explained, continued for a year and a half, and then she took additional 6 months. Manning PB 2009. for an According to Ms. Manning, she met with Respondent, three other One of the physicians, and an assistant. physicians explained to her what side effects could be caused by the drugs she would be taking and that the drugs were being prescribed “off label.” According to Ms. Manning, at the end of treatment she figured out that it cost less than doing the treatment that had originally been recommended, except that insurance did not cover the Clinic’s treatment. 926 Ms. Manning emphatically stated that she would not still be alive without Respondent.927 Ms. Ressel was St. 11 years old is the mother of a child when she was diagnosed Louis with a brain stem tumor was poor, the child only 925 Tr. Vol. 13 at 86. 92" Tr. Vol. 13 at 102-103. 927 Tr. V01. 13 at 107. who had 8 known to 18 as in survived cancer. She testified that her daughter 1996 by physicians DIPG months that was at Children’s Hospital in inoperable. to live, according to Her child’s prognosis Ms. Ressel, and the only I SOAH DOCKET NO. 503-14-1342.MD treatment offered When was PAGE PROPOSAL FOR DECISION would not have prevented her radiation therapy that 190 child’s death.928 she learned about Respondent’s success with treating brain cancer, Ms. Ressel said, she immediately made an appointment. After the was enrolled in a clinical trial for initial consultation with Respondent, her daughter ANP.929 According to Ms. Ressel, her daughter received ANP treatments for about a year. and 10 months. After five weeks, her daughter began to improve. Although her daughter experienced some side effects, Ms. Ressel said that they were not as bad as the side effects she would happen with radiation therapy. Because of Respondent’s treatment, her had been told child had a happy childhood and was able to play with her friends even while she was getting treatment. Her child is now 31 years old and has two children.930 humanitarian,” Ms. Mayo that Respondent is “a true who saved her child’s life.931 McGee is had less On May from Bozeman, Montana. Clinic with Stage told her she Ms. Ressel testified IV esophageal cancer than a that 2% chance of survival 11, 2011, she was diagnosed had spread throughout her torso. at the Her doctor and that he had other doctor friends who had When her daughter told her about Ms. McGee said that the Clinic used genetic— esophageal cancer and had chosen not to be treated.”2 Respondent, Ms. McGee made an appointment. targeted therapy to treat her cancer and within four PET months of starting treatment scan showed that her cancer was almost gone. Her last treatment at the Clinic, her was March 2012, and she has been cancer—free ever since.933 Mary Michaels testified that her son November 1985 her son was 4 92* Tr. Vol. 13 at 130-131. 929 Tr. Vol. 13 at 134-135. 93° Tr. Vol. 13 at 128-129, 138-139. 9“ Tr. Vol. 138. 932 Tr. Vol. 11 at 12-13. 933 Tr. Vol. 11 at28-29. was years old and treated by the Clinic from 1987 was diagnosed with to 2001. In optic hypothalamic glioma SOAH DOCKET NO. 503-14-1342.MD He underwent astrocytoma. PAGE PROPOSAL FOR DECISION She a craniotomy, and the biopsy supported the diagnosis.934 recalled that the doctors told her that her son was too little chemotherapy, but that he to receive However, the doctors explained could be treated with radiation. . would that radiation therapy cause her son to go blmd and he would experlence hear1ng loss and some braln damage. . 191 . . 935 Before coming to the Clinic, Ms. Michaels said, she sent her son’s scans to a physician Mayo who was doing Clinic robotic-assisted brain surgery to see if anything could be done at to save her son. The physician told her that no matter what she did, her son was going to die of the tumor. also He told her that “it was the saw largest tumor he had ever seen in anyone at any age.”936 She several other physicians, including a physician at the Cleveland Clinic, but found no one able to help her son.937 When she heard about Respondent, Ms. McGee said, she sent him a packet with her son’s A week later, medical records. treatment with anything recalled, ANP. According we had were doing . . were . she heard from the Clinic, and shortly thereafter her son began to Ms. McGee, the level of care at the Clinic seen before. Besides being very professional and very — knowing what they were very caring.”938 The side effects that her son experienced, Ms. minor.93’9 Her son remained on treatment with the Clinic RN/BSN, works in the emergency room children with learning disabilities. McGee stated: 93“ Tr. Vol. 10 at 114-115. 935 Tr. Vol. 10 at 99-100. 9” 93" 9” Michigan, and Tr. Vol. 10 at 101-102. Tr. Vol. 10 at 103. Tr. Vol. 10 at 109. Tr. Vol. 10 at 113. McGee is Her son is now an a personal trainer for His cancer has been in remission for about 16 years. pointed out that her son was sitting in the hearing Respondent. She 9“ in Pontiac, they for about 10 years, until about 2000. According to Ms. McGee, he never missed a day of school. Ms. “was unlike room and is alive because of SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 192 [E]very day there’s someone in some emergency room somewhere or some doctor’s office or hospital that’s getting the diagnosis that Paul got, and I know And those people have that hopeless feeling that you have and it’s horrible. there’s still no hope. If they no hope. We didn’t have hope in 1985; but in 2016, don’t have Dr. Burzynski, those kids are going to die and those families will never be the same. He’s the only hope for people that get that kind of cancer.”940 . Mary she . . Jo Siegel was another Clinic patient. In 1990, Ms. Siegel was diagnosed with non-Hodgkin’s lymphoma, Stage IV.941 was 40 years old when She recalled that her doctor at UCLA told her that she had a “fatal cancer and that they would treat me for a While with chemo and radiation but eventually to Ms. Siegel, she would I The prognosis was and her husband then went to the top lymphoma and the Dana-Farber Cancer fatal die of the disease.”942 Institute at poor. According specialists at USC, Stanford, Harvard. 'All of these doctors told her that “she had a prognosis,” and offered her no hope.943 Her husband had heard about the Clinic, so they made an appointment. According to Ms. Siegel, she received treatment with 2004. She has been a cancer survivor for 21 years and check—up.944 Over those 21 years, Ms. Siegel 5 has grandchildren.94 Ms. Siegel stressed ANP at the Clinic now only goes to the was able to from 1992 Clinic for an annual watch her children grow up and that she is healthy to now and happy today because of Respondent’s treatment. The ALJs find terminally treatment will ill fail. that Respondent has been of significant value cancer patients The ALJs are who aware to the either rejected conventional treatment or that, as community of had conventional with conventional cancer treatment, not every patient have a positive response to Respondent’s cancer treatments. But based on the evidence 94° Tr. V01. 10 at 116. 9‘“ Tr. v61. 10 at 148-149. 942 Tr. V01. 10 at 149. 943 Tr. V0]. 10 at 149-151. 94“ Tr. v61. 10 at 153-154. 945 Tr. V01. 10 at 162-163. SOAH DOCKET NO. 503-14-1342.MD PROPOSAL FOR DECISION presented, several patients have had positive results from his treatments PAGE 193 some of which have become more accepted and mainstream. XII. FINDINGS OF FACT Factual Background M.D. (Respondent or Dr. Burzynski) is a physician who holds Texas Medical License No. D-9377 that was issued by the Texas Medical Board (Board) in Stanley Burzynski, 1973. 2. 3. Respondent graduated from medical school in 1967, and received a biochemist doctorate in 1968 before immigrating to the United States in 1970. Between 1970 and 1977, Respondent worked at Baylor College of Medicine doing cancer research. 4. In 1977, Respondent opened the Burzynski Clinic (Clinic), a private medical practice in Houston, Texas, to 5. treat cancer patients. Respondent is not a board-certified oncologist, although he has treated cancer patients for almost 40 years. Procedural Histoty 6. Staff of the Board (Staff) filed the initial Complaint in this contested case on which was subsequently amended twice. The Second Amended Complaint (Complaint) filed on November 14, 2014, contains Staff’s notice of the December 11, 2013, allegations against Respondent. 7. On August Staff’s claims relating to 8. motion for summary disposition requesting alleged violations of federal regulations be dismissed. 21, 2014, Respondent filed a that Order No. 7 issued on September 10, 2014, granting Respondent’s motion in part, held that Staff’s alleged violations of non-criminal FDA-regulations pertaining to clinical studies of investigational new drugs are not subject to disciplinary action by the Board under 22 Texas Administrative Code (TAC) § 190.8(2)(R). SOAH DOCKET NO. 503-14-1342.MD PAGE 194 PROPOSAL FOR DECISION On September 24, 2015, Staff mailed the notice of hearing to Respondent. The notice of hearing contained a statement of the time, place, and nature of the hearing; the legal authority and jurisdiction under which the hearing was to be held; a reference to the particular sections of the statutes and rules involved; and a short plain statement of the factual matters asserted. time, place, and nature. 10. Respondent received adequate notice of the hearing, including 11. The hearing on the merits convened on November 19 through 20, and 23 through 25, 2015, January 19, Law 300 and May 3 through 6, and 9 through Judges Catherine Egan and West 15th St., Austin, Roy G. Scudday Texas. its 12, 2016, before Administrative William P. Clements Building, Lee Bukstein, Amy Swanholm, in the Attorneys Barbara Jordan, and Christopher Palazola represented Staff. Attorneys Dan Cogdell, J. Dennis Hester, J. Gregory Myers, and Melanie Rubinsky represented Respondent. The record closed on August 15, 2016, with the filing of the parties’ closing arguments and highlighted exhibits. The Clinic During the Relevant Period 12. The 13. began providing gene-oriented treatment with personalized treatment to the Clinic’s cancer patients. This purpose of this approach was to treat the cause of the cancer, abnormal genes, instead of the type of cancer. 14. 15. employed about 150 people, including three board-certified oncologists (Drs. Jai Joshi, Jose Valladares, and Zanhua Yi), two internists (Drs. Robert Weaver and Gregory Burzynski), one family practitioner (Dr. Alejandro Marquis), and several research associates who were unlicensed foreign—trained doctors. Clinic In the beginning of 1990, Respondent Approximately 95% of the Clinic’s cancer patients had terminal diagnoses, many of whom had tried other treatment protocols without success. Each patient at the Clinic was assigned a team of health care providers that included of whom consultation to discuss the proposed oncologist, either an internist or family practitioner, and a research associate, met with the patient treatment plan. and Respondent at the initial an all PAGE 195 PROPOSAL FOR DECISION SOAH DOCKET N O. 503-14-1342.MD Burzynski Research Institute/Institutional Review Board 16. Drug Administration (FDA) approved a clinical trial for drug antineoplaston (ANP) in the treatment of cancer patients. Over In 1993, the Federal the investigational the years, Respondent has engaged in 65 prospective clinical trials and one retrospective clinical trial. 17. 18. The Burzynski Research Institute (BRI), of which Respondent is the president and 80% owner of the shares, was created in 1983 to be involved in basic and clinical research on ANP and to sponsor FDA-approved clinical trials. Review Board (IRB) was also created in 1983 to supervise the ethical conduct of clinical studies by approving or disapproving clinical trial protocols; approving The Institutional or disapproving patient participation in clinical trials pursuant to those protocols; collecting data on the toxicity and the response of the investigational agent; and evaluating data on the efficacy of the investigational agent. 19. Neither Respondent nor any of the Clinic’s employees are members of the IRB. Standard of Care 20. In September 2010, Patient A, a 67-year-old man, Stage IV colon cancer with metastases to the with the medium was given a preliminary diagnosis of This type of cancer survival rate being approximately five months. liver. is uniformly fatal, 21. Patient A declined the conventional cancer treatment of surgery and chemotherapy. 22. Patient A had an initial consultation at the Clinic on October 7, 2010. 23. Patient A was treated by the Clinic from October 2010 through October 2011, and died on November 4, 201 1. 24. Patient B was December a 56-year-old man from the Ukraine who was diagnosed on with glioblastoma, grade IV, a fast-growing, aggressive central nervous system tumor that forms on the supportive tissue of the brain. 25. Patient 12, 2010, B had debulking surgery on December 20, 2010 to remove as much of the tumor as possible, but rejected the conventional treatment of radiation therapy and chemotherapy with Temodar (temozolomide). 26. On February 7, 2011, Patient B physician, Dr. Demetri Brandt, to travelled from Germany meet with Respondent. to the Clinic with his personal SOAH DOCKET NO. 503-14-1342.MD 27. B and After discussing various treatment options, Patient Respondent’s recommended treatment. 28. PAGE PROPOSAL FOR DECISION From February 7 through March 4, 196 Dr. Brandt elected to follow 2011, PatientB was treated at the Clinic with medications as directed by the Clinic’s oncologist, Dr. Valladares, that included sodium phenylbutyrate (PB), Votrient, Avastin, and Tarceva. 29. On March 4, 2011, Patient B left the Clinic and went to Germany, where Dr. Brandt began treating Patient B with ANP. 30. On July 6 through 7, 2011, based on Respondent’s recommendation, Patient administered Afinitor, Sprycel, and Nexavar while under Dr. Brandt’s care. 31. Dr. Brandt stopped treating Patient died on 32. December In 1986, Patient 18, On April with ANP at the end of September 2011. C was a 42-year-old 19, 2010, Patient man who was diagnosed with Stage II B A Nodular which surgical and radiotherapy were successful. C was diagnosed with cancer in his left lung. 34. Although Patient C’s local oncologist recommended chemotherapy, Patient consult with the Clinic on May 11, 2010. 35. After the initial Patient 2011. sclerosing Hodgkin’s disease for 33. B B was consultation C chose to and Dr. Joshi, Patient C was 14 through 20, 2010, with a regimen of PB, Tarceva, among Patient C, Respondent, from May Nexavar, Avastin, and Decadron (dexamethasone). treated at the Clinic 36. On May 20, 2010, Patient C left the Clinic and returned to his the care of his personal oncologist, Dr. Thomas protocol begun at the Clinic until October 2011, continue the recommended Waits, when home, where he was under who continued the treatment Dr. Waits chose to no longer treatments. was diagnosed on May 13, 2010, with brain cancer (pleomorphic xanthoastrocytoma, grade II) for which he had a surgical resection. 37. Patient D, a 28-year-old male, 38. Imaging studies taken on November 26, 2010, showed that Patient his brain and spine. 39. On D had new lesions in January 10, 2011, Patient D’s oncologist recommended chemotherapy treatment with Temodar and radiation. This treatment was continued through April 6, 2011, until it was stopped because Patient D was experiencing adverse reactions to the treatment. SOAH DOCKET NO. 503-14-1342.MD 40. On June 7, 2011, Patient D visited the Clinic for a consultation. 41. On July and left 1, 2011, Patient D PAGE PROPOSAL FOR DECISION 197 declined to follow Respondent’s treatment recommendations the Clinic. D never received treatment at the Clinic. 42. Patient 43. Patient E, a 67—year-old male, had chromophobic type renal cell carcinoma (kidney cancer) with multiple recurrences. 44. On September 7, 2011, Patient E had an initial consultation at the Clinic. 45. At Respondent’s recommendation, Patient E began treatment with the following medications: PB on September 8, 2011; Xgeva on September 13, 2011; Afinitor on September 14, 2011; and Sutent on September 15, 2011. 46. Patient 47. On E ceased treatments by the Clinic on October September 21, 2009, Patient 16, 2011. F, a 66—year-old male, was diagnosed with pancreatic cancer. 48. Although Patient F’s local oncologist recommended chemotherapy treatment, Patient F and his wife chose to consult with Respondent and the treatment team at the Clinic on October 8, 2009. 49. Patient F was 50. Patient F discontinued the treatment on November 51. Patient G, a 26-year—old from October 8 through November regimen of PB, Rapamune, Zolinza, Nexavar, Xeloda, and Avastin. treated at the Clinic 11, woman, was diagnosed on 11, 2009, with a 2009, due to financial constraints. July 5, 2012, with suprasellar mass brain cancer and malignant astrocytoma of the optic nerve. 52. Patient G underwent surgery on August 3, 2012, and was treated by her local oncologist with Avastin on August 24, 2012. 53. Patient G’s oncologist recommended that, after surgery, she be treated with radiation therapy and Temodar, but explained the radiation would probably cause her to go blind. 54. Patient 55. Patient G consulted with the Clinic on August 31, 2012. G was ineligible to participate in a clinical trial for previously received chemotherapy. ANP because she had SOAH DOCKET NO. 503-14-1342.MD 56. On September to receive 57. 6, ANP. 2012, the PROPOSAL FOR DECISION PAGE 198 FDA and IRB approved Patient G for a single-patient protocol From September 12 to November 26, 2012 Patient G was treated with ANP, but the treatment was discontinued because Patient G experienced consistent problems of edema in her legs. 58. In December 2012, Patient G began conventional cancer treatment in her home town with Temodar, and Avastin. The patient’s records indicate that she experienced edema, severe headaches, and other severe side effects, including a hospital admission with sepsis, while on conventional treatment. radiation, 59. There insufficient evidence to establish that Respondent violated the standard of care is by: (a) failing to make Patients of the combination of drugs; (b) failing Patients to A through G aware of the potential toxicities provide adequate medical rationale for treatment of A through G with ANP, PB, and/or the combined use of drugs; medical rationale for the evaluation, diagnosis, and treatment of Patients through G; or (c) failing to provide adequate A with the exception of informed consent regarding the below-described treatment of Patient E, providing inadequate medical documentation for (d) Patients 60. There is A through G. ‘ insufficient evidence that Respondent violated the standard of care in the treatment of Patients A, B, C, D, F, or G. 61. informed consent forms for each drug being used cancer meet the standard of care where the risks of combining the In a private practice concurrently to treat setting, drugs are unknown. 62. Prior to his treatment at the Clinic, Patient E had experienced toxicity with Votrient that had similar tyrosine kinase parameters as Sutent. 63. Between September 13 and Xgeva, Afmitor, and Sutent. 15, 2011, Patient E began treatment at the Clinic with PB, SOAH DOCKET NO. 503-14-1342.MD PAGE PROPOSAL FOR DECISION 199 64. According to the Clinic’s informed consent form for Afinitor that was reviewed with Patient E, the “purpose of treatment” section stated that Afinitor was a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with Sutent. 65. Patient E was treated with Afinitor at the Clinic before he which the drugs were administered together, as directed was treated with Sutent, after by Respondent. 66. Administering Afinitor to Patient E before treating with Sutent, and then administering them together, was a deviation from the procedure indicated in the Afinitor informed consent form that Patient E signed. 67. no documentation in Patient E’s medical records showing that Respondent explained, or had explained, to Patient E that the treatment protocol would deviate from that set out in the Afinitor informed consent form. 68. Patient There is E did not have an opportunity to give his informed consent to using these two drugs, Afinitor and Sutent, in a manner different from that disclosed on the Afinitor informed consent form that he signed. 69. Because Respondent did not provide Patient E with a written explanation for the deviation in the treatment protocol set out in the Afinitor informed consent form, Patient E did not give his informed consent for being treated with Afmitor before Sutent or for the simultaneous use of both drugs. 70. Respondent’s failure to ensure that Patient E received adequate information to explain that his treatment with Afinitor would be different from that disclosed in the informed consent form violated the standard of care. Inadequate Delegation and Improper Use 0] Unlicensed Practitioners 71. Respondent’s son, Dr. Gregory Burzynski, Board in January 2011. 72. Dr. Gregory Burzynski was responsible is a board—certified internist licensed by the for treating internal medical problems that arose while a patient received cancer treatments at the Clinic. a family physician licensed by the Board Clinic from 2006 until 2014. who worked 73. Dr. Alejandro Marquis 74. Dr. Gregory Burzynski and Dr. Marquis were responsible for assisting the treating is at the oncologists in monitoring and communicating with Clinic patients, ensuring the Clinic SOAH DOCKET NO. 503-14-1342.MD PAGE 200 PROPOSAL FOR DECISION received requested laboratory tests and scans in a timely manner, and managing any side effects a patient experienced 75. from the drugs prescribed by the treating oncologists. Dr. Gregory Burzynski and Dr. Marquis were qualified by training, experience, and licensure to perform the medical services they provided at the Clinic. 76. Tolib Respondent was responsible for the supervision of the Clinic’s research associates, including Tolib Rakhmanov, Mohammed Khan, Larisa Tikhomirova, Sheryll Acelar, and Lourdes DeLeon. Rakhmanov 77. RA Rakhmanov 78. RA Rakhmanov’s job duties at the Clinic included collecting the patient’s medical history, an unlicensed foreign-trained doctor research associate from 2006 to July 2016. is who worked at the Clinic as a obtaining the patient’s prior medical records, reviewing the informed consent forms with patients who elected to be treated at the Clinic, and communicating with the patient and the patient’s local oncologist once the patient returned 79. home. RA Rakhmanov did not conduct the patient’s physical examinations or diagnose and treat patients. 80. In a medical setting, results, by taking patient communicating with the patients’ histories, signing orders, reviewing laboratory local oncologists as “Dr. Rakhmanov,” wearing tag identifying himself as “Dr. Rakhmanov,” being addressed a white lab coat with a name at the Clinic as “Dr. Rakhmanov,” and signing Clinic forms, including informed consent forms, as a physician, Rakhmanov represented himself to the public as a licensed RA physician authorized to practice medicine. 81. 82. 83. Respondent supervised RA Rakhmanov, delegated medical acts to RA Rakhmanov, and permitted him to be misrepresented as a person authorized to practice medicine. Respondent had an obligation as a physician who supervised and delegated medical acts to RA Rakhmanov to ensure that he did not misrepresent his licensure, either directly or indirectly, and he failed to do so. Although RA Rakhmanov misrepresented that he was authorized to practice medicine, he only performed medical acts that he was qualified to perform and under a physician’s supervision. SOAH DOCKET NO. 503-14-1342.MD 84. There is PROPOSAL FOR DECISION insufficient evidence to show that RA PAGE 201 ‘ Rakhmanov engaged in the practice of medicine. 85. Respondent did not aid and abet RA Rakhmanov in the unlicensed practice of medicine. Mohammed Khan 86. RA Khan, an unlicensed foreign-trained doctor, has been employed by the Clinic as a research associate since 1997. RA Khan’s supervisor. 87. Respondent was 88. RA Khan worked as the Clinic’s radiology technician and was not directly involved with the Clinic’s patients. 89. RA Khan did not misrepresent to the public that he was authorized to practice medicine. 90. The Clinic does not take 91. its own radiology scans, and when outside radiology films arrived at the Clinic, RA Kahn collected them, downloaded them into the computer, and then showed them to the treating physicians. Although RA Khan took tumor measurements from scans he downloaded into the computer, Respondent remeasured the tumors to verify the measurements. 92. Respondent dictated 93. The to RA Khan what he wanted included in the radiology reports so that RA Khan could prepare Respondent’s written report. Clinic’s physicians relied official radiology report to 94. Larisa 95. make on their the radiologic imaging and the treatment decisions. Respondent did not improperly delegate medical acts RA Khan in the unlicensed practice of medicine. to RA Khan and did not aid and abet Tikhomirova Larisa Tikhomirova, an unlicensed foreign-trained doctor, research associate from July 2009 to 96. own review of May 2012. worked at the Clinic as a and 17, 2011, RA Tikhomirova signed Patient B’s informed consents as the “Physician performing consent.” She was identified on Patient B’s laboratory results as a physician, and signed Clinic forms as the patient’s physician, including a February 7, 2011 prescription for supplements and radiology orders issued on February 7 and March 4, 2011. On February 7, 15, SOAH DOCKET NO. 503—14-1342.MD RA Tikhomirova PAGE 202 PROPOSAL FOR DECISION 97. 2009 informed consent for Patient F’s pretreatment evaluation statement as the physician, and initialed the Clinic’s form entitled “Food Supplements” authorizing Patient F to have certain supplements. 98. Between October 9 through 99. RA Tikhomirova misrepresented to Patients B and F that she was signed the October 8, 2009, RA Tikhomirova signed Patient F’s informed consent forms for the drugs used in his treatment as the “Physician performing consent.” 15, a physician authorized to practice medicine. 100. Respondent supervised and delegated medical acts to RA Tikhomirova and permitted her to be misrepresented to the public as a person authorized to practice medicine. 101. Respondent had an obligation as a physician who supervised and delegated medical acts to RA Tikhomirova to ensure that she did not misrepresent her licensure, either directly or indirectly, and he failed to do so. 102. The medical acts that RA Tikhomirova performed were done under the supervision of a licensed physician. 103. RA Although Tikhomirova misrepresented practice medicine, there is was authorized to RA Tikhomirova was to the public that she insufficient evidence to establish that unqualified to perform the medical acts delegated to her by Respondent and the other licensed physicians. 104. There is insufficient evidence to show that RA Tikhomirova engaged in the practice of medicine. 105. Respondent did not aid and abet RA Tikhomirova in the unlicensed practice of medicine. Sheryl] Acelar 106. from 2010 identifying her as 107. worked at the Clinic as a research to 2014. At the Clinic, she was wore a white lab coat with a name tag “Dr. Acelar,” and was addressed by the Clinic staff as “Dr. Acelar.” Sheryll Acelar, an unlicensed foreign-trained doctor, associate RA Acelar’s job duties included taking the patient histories, communicating with the keeping records for Clinic physicians, ensuring that laboratory results were delivered to Clinic physicians, monitoring phone calls, and relaying messages about a patient, patient’s symptomatology in regards to the prescribed medications. SOAH DOCKET NO. 503-14-1342.MD 108. PAGE 203 PROPOSAL FOR DECISION RA Acelar reviewed the informed consent forms for Patients C and G, including the Pretreatment Evaluation and for the drugs Avastin and PB, and then initialed the forms as a physician. 109. When RA Acelar communicated with Patient C’s local oncologist, Dr. Waits, she identified herself as “Dr. Acelar.” 110. RA Dr. Waits reasonably believed Acelar was the contact physician at the Clinic for Patient C, addressed her as “Dr. Acelar,” and referred to her in written correspondence as “Sheryl Acelar, M.D.” 111. 2010, RA Acelar issued treatment orders in response to an email requesting permission to reduce the medication dosage that Patient C was receiving. She issued the treatment order to adjust this dosage without input from a licensed physician. On December 9, 112. RA Acelar authorized Patient 113. RA Acelar misrepresented to the public that she was 114. Respondent had an obligation as a physician who supervised and delegated medical acts G’s local oncologist to decrease her Decadron dosage and instructed the physician to put the patient back on ANP as soon as possible without instructions from a licensed physician to do so. authorized to practice medicine by signing informed consent forms as the patient’s physician, issuing orders, adjusting dosages, and calling herself “Dr. Acelar.” RA to Acelar to ensure that she did not misrepresent her licensure, either directly or indirectly. 115. Respondent permitted RA Acelar to misrepresent to the public that she was a person authorized to practice medicine. 116. RA Acelar was unqualified by licensure to make adjustments to a patient’s treatment. 117. Respondent Acelar by permitting her to sign medical records in the space designated for the physician’s signature and allowing her to make treatment decisions regarding Patients C and G. 118. Respondent aided and abetted failed to adequately supervise RA RA Acelar in the unlicensed practice of medicine. Lourdes DeLeon 119. Lourdes DeLeon, an unlicensed foreign-trained doctor, has worked as a research associate at the Clinic since 2005. SOAH DOCKET NO. 503—14-1342.MD 120. PAGE 204 PROPOSAL FOR DECISION RA DeLeon wore a white lab coat with a name tag identifying her as “Dr. DeLeon,” and signed consent forms and orders in the space designated for the physician’s signature, but she told Patient E and other patients when she first met them that she was not licensed in the United States. 121. 122. There is insufficient evidence that RA DeLeon misrepresented to the public that she was a person authorized to practice medicine. There is insufficient evidence to establish that RA DeLeon was unqualified to perform the medical acts that were delegated to her by Respondent and the other Clinic physicians. Respondent did not fail to supervise RA DeLeon, did not improperly delegate medical acts to her, and did not aid and abet her in the unlicensed practice of medicine. Informed Consent 123. The Clinic’s pretreatment evaluation statements given to Patients through G A through C and B represented that the patient would “be asked to sign a treatment specific consent form indicating that [he] understands that particular treatment and that [he] wished to receive that treatment regimen.” 124. A through After the treatment plans were established, Respondent failed to ensure Patients C and B through G received a more specific informed consent regarding the treatment plan to review and sign. 125. On 126. On 127. Respondent did not ensure that Patients B and F reviewed and signed the informed consent form for Avastin prior to having administered Avastin to them. 128. After Patient February 9, 2011, Patient B received treatment with Avastin, before he signed the informed consent form for Avastin on February 17, 2011. October 14, 2009, Patient F began treatment with Avastin, but the informed consent form was signed on October 15, 2009. C had returned home to Indiana, he was treated by his local oncologist, Dr. Waits. 129. While under Dr. Waits 130. The evidence is care, Patient insufficient to informed consent forms for of Dr. Waits. C’s medication was changed. show new drugs that it was Respondent’s administered to Patient C responsibility to secure while he was in the care SOAH DOCKET NO. 503-14-1342.MD PAGE 205 PROPOSAL FOR DECISION Off-labeled Use of FDA-Approved Drugs 131. show Respondent violated the Texas Occupations Code (Code) or any Board rule by identifying in the informed consents what uses of a drug had FDA approval rather than stating that he was using the drug “off-label.” There insufficient evidence to is that Alternative Therapy or Clinical Trials 132. The trial FDA is the regulatory agency with the authority to grant an application for a clinical and to make protocols and the 133. The sure that the clinical FDA regulations. trial is performed in compliance with the approved FDA approved the informed consent forms used by Respondent in the F DA-approved clinical trials. 134. Any been issues regarding the Clinic’s consent forms used for clinical trials have remedied through the proper process and Respondent, BRI, and the FDA. The FDA’s correspondence does not, without additional evidence, establish a violation of the Code or the Board rules. Disclosure of Ownership Interest in Pharmacies and Laboratory 135. Respondent is the sole owner of Southern Family Pharmacy and SRB Pharmacy (the pharmacies). 136. Southern Family Pharmacy was located in the same building as the Clinic. 137. Patients who received care from Respondent had their medication prescriptions filled at the pharmacies. 138. Patients who were prescribed PB and ANP could only have their prescriptions filled at the pharmacies. 139. Respondent did not disclose 140. The failure of Respondent to his patients his to disclose his ownership interests in the pharmacies. ownership interest in the pharmacies was unprofessional conduct. 141. 142. The SR Burzynski Lab, owned by Respondent, conducted laboratory analyses of samples taken for patients treated by Respondent and Respondent’s subordinates. It is in it. clear from the name SR Burzynski Lab that Respondent had some ownership interest SOAH DOCKET NO. 503-14—1342.MD 143. The failure of Respondent PAGE 206 PROPOSAL FOR DECISION to disclose his ownership interest in the laboratory was not unprofessional conduct. Improper Charges and Retainer Demands 144. There is insufficient evidence to establish any improper charges were made by Respondent to Patients A, D, and F. 145. On February services 7, 2011, Respondent charged Patient B $350 for prolonged physician and $500 for prolonged service without contact. On 146. February 10, 2011, Respondent charged Patient Dr. Gregory Burzynski. 147. On February 28 and March 2, B $125 for a 2011, Respondent charged Patient B Respondent with $60 each for group health education. 148. visit ' failed to document adequate support for the above-described charges to Patient B. 149. Respondent charged Patient C $125 for each phone evaluation/maintenance held on June 23, July 2, July 13, July 27, August 10, August 17, August 23, September 27, and December 14, 2010, and August 31, 2011. 150. Respondent failed to document adequate support for the above-described charges to Patient C. 151. On 152. Respondent September 10 and 11, 2011, Patient E was charged $95 each for after-hours medical services, and on September 16, 2011, Patient E was charged $100 for an office visit. failed to document adequate support for the above—described charges to Patient E. 153. On September 16, and 23, 2012, Patient G was charged $95 each for after-hours medical services. 154. CPT Code No. 96416 requires continuously present 155. when ANP is that a nurse or other licensed health provider be given to the patient through a pump. 2012, the medical records document that Patient G was charged $170 for a first infusion and $395 for a second infusion even though the records do not identify a health professional who was present during these two infusions. On September 12, SOAH DOCKET NO. 503-14-1342.MD 156. From September of ANP at the Clinic Code 96416 even though the records do not 13 through 22, 2012, Patient 158. G received infusions which she was charged $395 under CPT identify a health professional who was present during the for 157. infusions. Respondent improperly billed Patient G for infusion charges under CPT Code 96416 even though no nurse or other licensed health provider was documented as being continuously present when the ANP infusions were given to Patient G through a pump. On September 29 through October November October 23 through 27, November 19, 5 through 14, 2012, Patient G self-administered the they were not administered by a health professional at the Clinic. G was improperly charged $395 159. Patient 160. On 161. Patient G’s Daily Worksheets CPT Code 96416. for each ANP and home; 1, infusions at of the self-administered infusions under September 12, 2012, Patient G was counseled by someone at the Clinic about control and appropriate diet while on ANP treatment, for which she was charged $60. September 3 These charges were coded as CPT Code 99078, the code education from a physician in a group setting. 163. Respondent failed to training to Patient Respondent birth documented that she attended ANP training from through 21, 2012, for which she was charged $60 per day of training. 162. 164. PAGE 207 PROPOSAL FOR DECISION show when patients receive document adequate support to document adequate support for the above—described charges to G in a group setting. failed to to use that a physician provided Patient G. 165. The failure to document support for the above-described charges resulted in inadequate medical records for Patients B, C, E, and G. Deceptive Marketing and Advertising 166. There is insufficient evidence to establish that Respondent used advertising statements that were false, misleading, or deceptive. Ethical and Professional Responsibilities In Clinical Trials 167. Respondent was the principal investigator trials. at the Clinic for all FDA-approved clinical SOAH DOCKET NO. 503—14-1342.MD 168. Patients 169. Patient 170. There There B was not treated with ANP at the Clinic. is insufficient evidence to is show insufficient evidence to show that by failing to report Patient protocol approved by the FDA. There is show to treatment in Respondent I’s Respondent failed to protect Patient failed to protect Patient 1 G by in the adverse events in compliance with the BT-10 Respondent inaccurately measured Patient I’s accordance with the BT-lO protocol approved by the FDA. insufficient evidence to tumor response that from ANP treatments. clinical trial 172. PAGE 208 A through F were not participating in FDA-approved clinical trials. failing to report adverse events 171. PROPOSAL FOR DECISION that 173. Respondent’s classification of Patient J’s response to treatment as “stable disease” (SD) was in compliance with Protocol BT—l 0. 174. The evidence is insufficient to establish that Respondent measured Patient J’s lesions inaccurately or misrepresented the tumor’s progression to the child’s parents. 175. There is insufficient evidence to establish that Respondent misdiagnosed Patient N’s cancer or that Respondent inaccurately reported the results of Patient N’s imaging studies. 176. There is insufficient evidence to or that they received 177. There is There is 0 and P participated in a clinical study insufficient evidence to establish that Respondent misrepresented Patient S’s response to 178. ANP. show that Patients ANP or skewed the results of the tumor measurements. insufficient evidence to parents on show that the Clinic failed to properly train Patient T’s how to use the pump or that Respondent misrepresented Patient T’s response to ANP by skewing the results of the tumor measurements. 179. Respondent inaccurately reported Patient Q’s tumor measurements, causing the classification of the tumor’s response to treatment to be in error. 180. There is insufficient evidence to establish that Respondent was required to report overdoses caused by operator errors or that he failed to report adverse events that occurred as required 181. by the clinical study. Respondent did not disclose in the informed consent forms given to patients in FDA— approved clinical trials the additional costs related to ANP treatment, but he did disclose this information before initiating treatment in the billing agreement signed by each patient. SOAH DOCKET NO. 503-14-1342.MD Respondent did not engage PAGE 209 PROPOSAL FOR DECISION 182. and unethical conduct by disclosing before treatment the additional costs of participating in an ANP clinical trial in a treatment billing agreement rather than in the informed consent form. 183. There is in unprofessional insufficient evidence to establish that Respondent failed to adequately train his subordinates about adverse events and the need to document and report them to a licensed physician. 184. There is insufficient evidence to show that their families, or the Clinic staff on proper 185. Respondent failed to train and pump use for ANP infusions. retrain patients, ' Respondent considered and reported the impact of Patient G’s taking of corticosteroids on her treatment. 186. There is insufficient evidence to establish that Respondent failed to isolate the impact of corticosteroid use 187. 188. on Patient G’s tumor. Respondent informed Patient G of the additional costs that she might incur treatment before she began receiving the treatment. in her cancer Except for Finding of Fact No. 179, the credible evidence failed to show that Respondent violated his ethical duty and responsibilities as a clinical investigator. Aggravating and Mitigating Factors 189. Based on the above-stated findings of fact, there is insufficient evidence that any of Respondent’s patients suffered actual harm to their health by a violation of the standard of care or having inadequate records. 190. Based on the above-stated findings of fact, there is insufficient evidence that any of Respondent’s patients were actually harmed by his failure to ensure that RAs Rakhmanov, Tikhomirova, and Acelar did not directly or indirectly represent to the public that they were authorized to practice medicine. 191. Based on the above—stated findings of fact, there is insufficient evidence Respondent’s patients were actually harmed by his allowing RA Acelar that any of to practice medicine without a license. 192. Based on the above—stated findings of fact, there is insufficient evidence that any of Respondent’s patients were economically harmed by his failure to disclose his ownership interest in the pharmacies. SOAH DOCKET NO. 503-14-1342.MD 193. PAGE 210 PROPOSAL FOR DECISION Based on the above—stated findings of fact, there is insufficient evidence that any of Respondent’s patients were economically harmed by his failure to have adequate medical records to support Clinic charges. 194. Based on the above-stated findings of fact, Respondent’s adequate informed consent to more than one patient. 195. Based on the above-stated findings of fact, unless corrected for the future, the following actions by Respondent could represent potential harm to the public: (1) failing to ensure that research associates did not directly or indirectly represent to the public that they were failed to obtain timely and/or authorized to practice medicine, (2) allowing a research associate to practice medicine without a license; (3) failing to disclose his ownership interest in the pharmacies; and (4) failing to have adequate medical records to support Clinic charges. 196. 197. On August 31, 1994, the Board suspended Respondent’s license for a period of ten years, but probated the suspension. The basis of the action was that Respondent had treated patients with ANP in violation of the laws in effect at that time and had made false advertisements about ANP. Based on the above stated Findings of Fact, Respondent did not treat patients with ANP in violation of the laws in effect during the relevant time period and did not make false advertisements about ANP during the relevant time period. Accordingly, Respondent has not been disciplined by the Board for prior similar violations. 198. For almost 40 years, Respondent has devoted himself to treating terminally ill cancer patients who have either rejected conventional cancer treatments or had tried conventional treatments without success. Some of Respondent’s treatments have become more accepted and mainstream. 199. If Respondent is unable to continue practicing medicine, critically treated with ill cancer patients being ANP under FDA-approved clinical'trials or a special exception will no longer have access to this treatment. 200. Respondent’s continued practice in treating advanced cancer patients the cancer community. 201. Respondent’s treatments have saved the who were not expected to live. lives is a present value to of cancer patients, both adults and children, SOAH DOCKET N O. 503-14-1342.MD XIII. CONCLUSIONS OF LAW The Board has jurisdiction over this matter pursuant to Code The State PAGE 211 PROPOSAL FOR DECISION Office of Administrative Hearings has title 3, subtitle B. jurisdiction over the hearing in this proceeding, including the authority to issue a proposal for decision with proposed findings of fact and conclusions of law, pursuant to Texas Government Code ch. 2003. Respondent was adequately and timely apprised of the hearing and the factual allegations against him. Tex. Gov’t Code §§ 2001 051-052. case by a preponderance of the evidence, while Respondent had the burden of proving the elements of any claimed Staff had the burden of proving the elements of exemption under the law. The Board has 1 TAC § 155.427. authority to take disciplinary action against a licensee statutes or rules regarding physicians, or professional its who violates the has failed to practice medicine in an acceptable manner consistent with public health and welfare. Code § l64.051(3), (6). FDA regulations pertaining to clinical studies of investigational new drugs are not subject to disciplinary action by the Board under 22 TAC § 190.8(2)(R). Non-criminal document the risk factors of, or explain the deviation from, the prescribed treatment plan, and to give Patient E the opportunity to give his informed consent to the simultaneous use of two specific drugs, in violation of 22 TAC §§ 165.1(a)(5), (7) and 190.8(1)(I). Respondent is subject to sanction for failing to Respondent is subject to sanction for failing to supervise RAs Rakhmanov, Tikhomirova, and Acelar to ensure that they did not represent to the public that they were authorized to practice medicine, in violation of Code §§ 164.052(a)(5) and l64.053(a)(8), (9). RA Acelar in the unlicensed Respondent is subject to sanction for aiding and abetting practice of medicine, in violation of Code §§ l64.052(17) and l64.053(a)(9). 10. is subject to sanction for failing to give Patients A through C and E through G a more specific informed consent form regarding the treatment plan to review and sign, Respondent and informed consent for Avastin from Patients 190.8(1)(G), (H) and (I) and 200.3(2). for failing to timely obtain violation of 22 TAC §§ 11. Respondent is subject to sanction for failing to disclose his ownership pharmacies to his patients in Violation of 22 TAC § 190.8(2)(H). 12. Respondent is B and F, in interest in the subject to sanction for failing to maintain adequate medical records to support charges to Patients B, C, and E, in violation of 22 TAC § l65.1(a)(9). SOAH DOCKET NO. 503-14-1342.MD 13. Respondent is PROPOSAL FOR DECISION PAGE 212 subject to sanction for failing to maintain adequate medical records to support charges to Patient G, in Violation of 22 TAC §§ 165.1(a)(9) and 190.8(2)(J). 14. Respondent is subject to sanction for inaccurately reporting Patient Q’s tumor measurements, causing the classification of the tumor’s response to treatment to be in error, in Violation of 22 TAC § 200.3(7)(A). 15. Aggravating and mitigating factors actions. 22 TAC § 190.15. may be considered by the Board in disciplinary SIGNED October 12, 2016. ~~ V“ .. A 5mm {Imam 0? LAW Jamar ~ CATHERINE c. EGAN ADMINISTRATIVE LA JUDGE STATE OFFICE or ADMINISTRATIVE HEARINGS _ , SOAH DOCKET NO. 503-14-1342.MD PAGE 213 APPENDIX A APPENDIX A LIST OF MEDICINES BURZYNSKI BOARD MATTER Chemotherageutic Agent Key Br‘a d Name Name everolimus Afinitor ed Alimta Avastin sodium ix‘inotecan Eloxatin . FOLFO ‘ or O latin Combination Foli‘nic Acid and Fluorouracil citabine Nexavar sorafenib P latin sirolimus S dasatinib Sutent sunitinib Tarceva erlotinib Temodar temozolomide Veclibix 'tumumab V b Xeloda tabinc denosumab APPENDIX A LIST OF MEDICINES . Rg 1 (a q APPENDIX A SOAH DOCKET NO. 503-14-1342.MD vorinostat Zolinza OTHER: Decadron . - dexamethasone PAGE 214