3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance JUNE 22,2011 Press Contact: Communications O©ce (Baucus) 202-224-4515 Jill Gerber (Grassley) 202-224-6522 Baucus, Grassley Question Medtronic about Unreported Side E¤ects, Financial Ties to Clinical Investigators Finance Leaders Begin Investigation Into Medtronic Infuse Trials Washington, DC – Senate Finance Committee Chairman Max Baucus (DMont.) and senior Committee member Chuck Grassley (R-Iowa) asked medical device manufacturer Medtronic on Tuesday to produce documents related to its controversial bone growth product Infuse.  In a letter sent to Medtronic, the Committee raised concerns over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been aware of and failed to report evidence that the product may cause sterility in men and potentially-harmful bone growth.  The letter also notes many of these investigators had substantial Ÿnancial ties to the device manufacturer. http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 1/7 3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance  “These reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side e¤ects for patients are deeply troubling,” said Senate Finance Committee Chairman Baucus.  “Information is one of the most important tools patients and doctors have when making medical decisions.  Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information.  We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase proŸts.”  “A patient having surgery has to rely on his doctor’s knowing the risks and beneŸts of a medical device.  The doctor in turn has to rely on the medical literature.  If the medical literature has been written by those with Ÿnancial ties to the device maker, the doctor and his patient should know that.  A lack of transparency leaves doctors and patients in the dark on something any of us would want to know before surgery.  It’s alarming to learn after the fact that articles draw con icting conclusions about a device’s safety and complications.  The lack of disclosure of payments raises questions about the integrity of the conclusions reached, whether integrity was compromised or not,” senior committee member Grassley said. The full text of Baucus’s and Grassley’s letter to Medtronic appears below: June 21, 2011 Via Electronic Transmission Omar Ishrak, Ph.D. Chairman and Chief Executive O©cer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 2/7 3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance Dear Dr. Ishrak: The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs.  As Chairman and a senior member of the Committee, we have a special responsibility to the more than 100 million Americans who receive health care under those programs to ensure that beneŸciaries receive treatments that are safe and e¤ective.  We are extremely troubled by press reports suggesting that doctors conducting clinical trials examining the safety and e¤ectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature.  This issue is compounded by the fact that some clinical investigators have substantial Ÿnancial ties to Medtronic.  Last year, the Milwaukee Journal Sentinel reported that a Medtronic-funded study published in 2004 found that 75% of bone morphogenetic protein 2 (BMP-2) patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area.  The authors, who had Ÿnancial ties to Medtronic, “concluded that ‘although not desirable,’” the ectopic bone growth “did not appear to have an ill e¤ect on the patients.” However, in a separate 2008 study conducted by physicians without Ÿnancial ties to Medtronic, “neurological impairment occurred” in Ÿve patients who had the same ectopic bone formation.[1] According to the New York Times, a recent study “found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft.”  This link to sterility was http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 3/7 3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance not reported in the original Medtronic-funded study.[2]  In addition, the Milwaukee Sentinel Journal reports that one author of the original study, Thomas A. Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, received “more than $23 million in various royalty payments from Medtronic since 2002.”  In addition, “Zdeblick also is the editor of the journal where two of the Infuse papers that failed to mention the link [to sterility] were published.”[3] We are also concerned that other severe side-e¤ects of Infuse and similar bone-growth products developed by Medtronic may have been unreported or under-reported in clinical literature.  Reports have linked Infuse to potentially fatal swelling in the neck and throat, and radiating leg pain.  Concerns have also been expressed about a potential link to cancer.[4]  Given these concerns, please provide the Committee with the following documents: 1.  All documents and communications pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments, including but not limited to: a.  All communications with and regarding medical journals or their representatives pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments.  b.  All communications with and regarding clinical investigators who participated in Medtronic sponsored clinical trials pertaining to adverse postoperative events and/or medical complications relating to http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 4/7 3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance the use of rhBMP-2 treatments.  c.  All communications with and regarding the Food and Drug Administration (FDA) pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.   d.  All communications and records between and among Medtronic and members of FDA Advisory Boards pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.   e.  All communications and records between and among Medtronic and physician consultants pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.  2.  A detailed account of payments that Medtronic made to all Infuse clinical investigators.  Please include payments to corporate entities in which Medtronic-sponsored Infuse clinical investigators are principals. 3.  For each individual and organization identiŸed in question number 2 above, please provide the following information for each payment in table format: a. Date of payment b. Payment description (CME, royalty, honorarium, research support, etc.) c. Amount of payment d. Year end or year-to-date payment total http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 5/7 3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance In cooperating with the Committee’s review, no documents, records, data, or other information related to these matters, either directly or indirectly, shall be destroyed, modiŸed, removed, or otherwise made inaccessible to the Committee.  We look forward to hearing from you by no later than July 11, 2011. All documents responsive to this request should be sent electronically, on a disc, in searchable PDF format to [sta¤] and [sta¤]. If you have any questions, please do not hesitate to contact [sta¤] with Senator Baucus at (202) 224-4515 or [sta¤] with Senator Grassley at (202) 224-6522. Sincerely,   Charles E. Grassley                                                             Max Baucus Senator                                                                              Chairman     [1] “Complications rise along with o¤-label use of BMP-2,” Journal Sentinel, August 28, 2010. [2] “New Study Links Spine Product From Medtronic to Risk of Sterility in Men,” New York Times, May 25, 2011. [3] “Researchers get royalties, papers omit sterility link,” Journal Sentinel, May 25, 2011. [4] “Complications rise along with o¤-label use of BMP-2,” supra note 1. ### http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 6/7 3/25/2016 Chairman's News   Newsroom   The United States Senate Committee on Finance Related Files 06222011 Baucus, Grassley Question Medtronic about Unreported Side E¤ects, Financial Ties to Clinical Investigators.pdf Recent News 03/23/16Senate and House Committee Leaders Seek Answers from Administration on 316 Security Breaches on HealthCare.gov 03/18/16Obamacare at Six Years: Republicans Chart Path Towards Repeal and Replace 03/17/16Hatch Says Responsible Solutions Needed for Puerto Rico’s Debt Crisis 03/17/16Obamacare at Six Years, CO-OP Failures Leave Half a Million Scrambling 03/17/16Hatch Statement at Finance Committee Hearing on Obamacare at Six Years http://www.finance.senate.gov/chairmans­news/baucus­grassley­question­medtronic­about­unreported­side­effects­financial­ties­to­clinical­investigators 7/7