REPORT: EXPOSINO DANGEROUS OPIOID MANUFACTURER INFLUENCE AT THE WORLD HEALTH ORGANIZATION MAY 22, 2019 FROM THE OFFICES OF REPRESENTATIVES KATHERINE CLARK 8 HAL ROOERS ........................................................................................................................... ii .............................................................................. 1 ...................................................................................... 1 ....................................................... 6 ......................................................................13 ........ 28 .........................................................................................................................30 ......................................................................................................................................31 i. Executive Summary In 2017, several members of Congress sent a letter to the World Health Organization (WHO) warning that Purdue Pharma L.P. (Purdue), was attempting to expand their drug sales to international markets using the same fraudulent marketing tactics that instigated the opioid crisis in the United States. We expressed our concern that Purdue?s expansion could trigger an opioid crisis on a global scale. When the WHO failed to respond to the letter, we began to question why they would remain silent about such a signi?cant and devastating public health epidemic. The answers we found are deeply disturbing. In the 1990s, Purdue and the Sackler family, the company?s owners, developed an aggressive marketing strategy to increase its sales of OxyContin. According to Purdue?s own internal planning documents, the company sought to in?uence the recommendations on how health care providers and policy makers should administer prescription opioids. Almost a decade later, multiple aspects of Purdue?s marketing strategy were included in two WHO guidelines on opioid prescribing. In 2011, the WHO published a document called Ensuring Balance in National Policies on Controlled Substances, Guidance forAvaiIability and Accessibility of Controlled Medicines (Ensuring Balance). Ensuring Balance was written as an update to a previous WHO guideline that focused solely on cancer pain. Ensuring Balance corroborates the oft?repeated Purdue claim that dependence occurs in less than one percent of patients, despite no scientific evidence supporting this claim and a multitude of studies contradicting it. It states: ?Opioid analgesics, if prescribed in accordance with established dosage regimens, are known to be safe and there is no need to fear accidental death or dependence.? Following the publication of Ensuring Balance, the WHO published a second document in 2012 called Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses (Persisting Pain in Children). This document was also created as an update to a previous guideline that focused exclusively on using opioids to treat cancer pain in children. This guideline uses the marketing term coined by the opioid industry and utilized often by Purdue: ?opiophobia.? Opiophobia is how the opioid industry defines a physician?s ?unreasonable fear? of prescribing opioids. Persisting Pain in Children tries to overcome ?opiophobia? by emphasizing the safety of opioids. The WHO claims that there is no maximum dosage of strong opioids, like OxyContin, for children. The WHO published this claim despite the fact that U.S. public health agencies have found that fatal Executive Summary overdoses skyrocket in adult patients who are prescribed above 90 morphine milligram equivalents (MME) per day. What is most striking about Persisting Pain in Children is that it completely eliminates the second step on the model of treating pain: a three?step pain treatment ladder. Under the initial guideline, the WHO recommended that physicians start pain patients on non?opioids like Tylenol before moving patients ?up the ladder? to a combination of non?opioids with low strength opioids. If the first two steps were unable to treat the patient?s pain, then the WHO recommended moving up to strong opioids like OxyContin. Purdue?s planning documents from the late 19908 identi?ed replacing combination drugs with OxyContin on step two of the pain ladder as an important part of their marketing strategy. In 2012, the WHO gave Purdue exactly what they wanted. Now, in Persisting Pain in Children, if a child?s pain is assessed as moderate to severe, the WHO recommends skipping step two altogether and moving straight from non?opioid medication to strong opioids such as OxyContin. Evidence shows that the content in Ensuring Balance and Persisting Pain in Children was in?uenced by many organizations and individuals known to have ?nancial ties to Purdue and to other major players in the opioid industry. The web of in?uence we uncovered, combined with the recommendations, paints a picture of a public health organization that has been manipulated by the opioid industry. It is concerning that the recommendations in these two documents, containing content that bene?ts the opioid industry, is now being used as reference material for a multitude of other publications. We are highly troubled that, after igniting the opioid epidemic that cost the United States 50,000 lives in 2017 alone and tens of billions of dollars annually, Purdue is deliberately using the same playbook on an international scale. Moreover, we are disturbed that the WHO, a trusted international agency, appears to be lending the opioid industry its voice and credibility. Based on the course of events that has taken place in the U.S. over the past 20 years, if the recommendations in these WHO guidelines are followed, there is a signi?cant risk of sparking a worldwide public health crisis. The following report is a compilation of publicly available information that details how Purdue was able to accomplish its goal of disseminating misleading information on opioid prescribing to the international community. This report raises questions about the integrity and accuracy of the opioid prescription guidelines and the in?uence Purdue may have had on their development. As we are limited to publicly available Executive Summary information, it is possible that there may be more to uncover regarding Purdue and the Sackler family?s efforts to expand internationally. Section I & II Jonathan Stempel,“New York Sues OxyContin Maker Purdue Over Opioids,” Reuters, Aug. 14, 2018, www.reuters.com/article/us-usa-opioids-purduepharma/new-york-sues-oxycontin-maker-purdue-pharma-overopioids-idUSKBN1KZ1WZ; Tom Winter and Rich Schapiro, “Pennsylvania sues Oxycontin maker Purdue Pharma, says it targeted elderly and vets,” NBC News, May 15, 2019, https://www.nbcnews.com/news/usnews/pennsylvania-sues-oxycontin-maker-purdue-pharma-says-it-targeted-elderly-n1005586. 2 Harriet Ryan, Lisa Girion, Scott Glover, “OxyContin Goes Global—“We’re Only Just Getting Started,”” Los Angeles Times, Dec. 18, 2018, www.latimes.com/projects/la-me-oxycontin-part3/. 3 Purdue Pharma, “About Purdue Pharma”, last modified 2019, (accessed February 2019) https://www.purduepharma.com/about/#&panel1-36; Harriet Ryan, Lisa Girion, Scott Glover, “‘You Want a Description of Hell?’ OxyContin’s 12-Hour Problem,” Los Angeles Times, May 5, 2016, www.latimes.com/projects/oxycontin-part1/. 1 1 Section II Purdue Pharma, “1996 Budget Plans,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdueand-the-oxycontin-files/; Purdue Pharma, “1997 Budget Plan,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdue-and-the-oxycontin-files/. 5 David Armstrong, “Secret Trove Reveals Bold ‘Crusade’ to Make OxyContin a Blockbuster,” STAT News, Sept. 22, 2016, www.statnews.com/2016/09/22/abbott-oxycontin-crusade/. 6 Aaron Kessler, Elizabeth Cohen, Katherine Grise, “CNN Exclusive: The More Opioids Doctors Prescribe, The More Money They Make,” CNN, March 12, 2018, www.cnn.com/2018/03/11/health/prescription-opioid-paymentseprise/index.html; Celine Gounder,“Who is Responsible for the Pain-Pill Epidemic?,” The New Yorker, November 8, 2013,online at www.newyorker.com/business/currency/who-is-responsible-for-the-pain-pill-epidemic; Andrew Kolodny, David T. Courtwright, Catherine S. Hwang, Peter Kreinter, John L. Eadie, Thomas W. Clark, and G. Caleb Alexander, “The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction,” Annual Review of Public Health no. 36 (2015):559-74. 7 Purdue Pharma, “1997 Budget Plan,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdueand-the-oxycontin-files/. 8 Purdue Pharma, “1998 Budget Plan,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdueand-the-oxycontin-files/. 9 David Armstrong,“Purdue’s Sackler Embraced Plan to Conceal OxyContin’s Strength from Doctors, Sealed Deposition Shows,” STAT, February 21, 2019, online at https://www.statnews.com/2019/02/21/purdue-pharmarichard-sackler-oxycontin-sealed-deposition/. 4 2 Section II 10 World Health Organization, Geneva, Cancer Pain Relief, 1986, (accessed May 20, 2019) https://apps.who.int/iris/bitstream/handle/10665/43944/9241561009_eng.pdf. The WHO created the 3-step pain ladder in 1986. 3 Section II Purdue Pharma, “1996 Budget Plans,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdueand-the-oxycontin-files/. 12 Id. 13 Purdue Pharma, “2001 Budget Plans,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdueand-the-oxycontin-files/. 14 Barry Meier, Pain Killer: A "Wonder" Drug's Trail of Addiction and Death (United States of America: Rodale Inc., 2003), 8, 99, https://books.google.com/books?hl=en&lr=&id=c4sqrn5WAwYC&oi=fnd&pg=PA5&ots=vmvuMnsp93&sig=Mb 9PxUviMUwIDOhQ359Y739Ve54#v=onepage&q&f=false; Van Zee, The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, American Journal of Public Health (Feb. 2009); How a Short Letter in a Prestigious Journal Contributed to the Opioid Crisis, Washington Post, (June 2, 2017) (online at https://www.washingtonpost.com/news/morning-mix/wp/2017/06/02/how-the-opioid-crisis-traces-back-to-a-fivesentence-scholarly-letter-from-1980/?utm_term=.67a850250963); This One-Paragraph Letter May Have Launched the Opioid Epidemic, Business Insider (May 26, 2016) (online at www.businessinsider.com/porter-and-jick-letterlaunched-the-opioid-epidemic-2016-5). In 1980, Doctor Hershel Jick and his graduate student sent a short letter to the New England Journal of Medicine claiming that individuals are unlikely to develop an addiction after using painkillers. Unfortunately, their methodology was later shown to be unsound and never confirmed. Instead, over 11 4 Section II 600 scholars have inaccurately cited this letter and spread the misinformation. This letter was also widely used by opioid manufacturers to back up their claims that opioids carried a very low risk of addiction. 15 Complaint, Commonwealth v. Purdue Inc. et al, No. 1884-cv-01808, at 24, Mass. Super. Ct. June 12, 2018, www.mass.gov/files/documents/2018/06/12/Purdue%20Complaint%20FILED.pdf. 16 Id., at 28-29. 17 German Lopez, “The Maker of OxyContin Will Finally Stop Marketing the Addictive Opioid to Doctors,” Vox, Feb. 12, 2018, online at www.vox.com/science-and-health/2018/2/12/16998122/opioid-crisis-oxycontin-purdueadvertising; see note 2 (OxyContin Goes Global). 5 Section II & III Celine Gounder, “Who is Responsible for the Pain-Pill Epidemic?,” The New Yorker, November 8, 2013, online at www.newyorker.com/business/currency/who-is-responsible-for-the-pain-pill-epidemic. 19 Andrew Kolodny, David T. Courtwright, Catherine S. Hwang, Peter Kreinter, John L. Eadie, Thomas W. Clark, and G. Caleb Alexander, “The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction,” Annual Review of Public Health no. 36 (2015):559-74. 20 Katherin Eban, “OxyContin: Purdue’s Painful Medicine,” Fortune, November 9, 2011, fortune.com/2011/11/09/oxycontin-purdue-pharmas-painful-medicine/; Julie Scharper, “Administered for Pain, Drugs like OxyContin Have Taken a Massive Toll,” Johns Hopkins Magazine, Fall 2016, hub.jhu.edu/magazine/2016/fall/opioid-addiction-pain-management/. In 1996, the year OxyContin was released on the market, they made $45 million. In 2002, they made $1.5 billion and then doubled their sales in seven years, pulling in nearly $3 billion in 2009. Overall, prescription opioid sales nearly quadrupled from 1999 to 2014. 21 John Fauber, “UW a Force in Pain Drug Growth,” Journal Sentinel, Apr. 4, 2011, archive.jsonline.com/watchdog/watchdogreports/119130114.html/; World Health Organization, Achieving Balance in National Opioids Control Policy: Guidelines for Assessment, 2000, http://apps.who.int/medicinedocs/pdf/whozip39e/whozip39e.pdf. Purdue’s involvement may have begun earlier than 2007. In 2000, the WHO Collaborating Centre for Policy and Communications in Cancer Care at the University of Wisconsin Pain & Policy Studies Group published a guideline, Achieving Balance in National Opioids Control Policy: Guidelines for Assessment, which would serve as the basis for the WHO’s later document: Ensuring Balance in National Policies on Controlled Substances: Guidance for Availability and Accessibility of Controlled Medicines. In 2011, the WHO Collaborating Centre for Policy and Communications in Cancer Care at the University of Wisconsin Pain & Policy Studies Group revealed that from 1999 to 2010, it had accepted over $1.6 million from Purdue. 18 6 Section III 24 22 World Health Organization, WHO Normative Guidelines on Pain Management: Report of a Delphi Study to Determine the Need for Guidelines and to Identify the Number and Topics of Guidelines that Should be Developed by WHO, Jun. 2007, www.who.int/medicines/areas/quality_safety/delphi_study_pain_guidelines.pdf; Matthew Perrone, “Federal Pain Panel Rife with Links to Pharma Companies,” The Seattle Times, January 27, 2016, www.seattletimes.com/business/federal-pain-panel-rife-with-links-to-pharma-companies/). In addition to these opioid industry-funded organizations, the WHO’s final report of the Delphi Study consulted individuals known for their advocacy in favor of expanding the use of prescription opioids. Principal among these was Kathleen Foley, a central figure in the opioid industry’s campaign (see Table 2). Her work has been so valuable to Purdue that the company donated $1.5 million to endow a chair in her name. 23 RAND Corporation, “Delphi Method,”(accessed May 2, 2019) https://www.rand.org/topics/delphi-method.html. 24 World Health Organization, Ensuring Balance in National Policies on Controlled Substances: Guidance for Availability and Accessibility of Controlled Medicines, 2011, apps.who.int/iris/bitstream/handle/10665/44519/9789241564175_eng.pdf?sequence=1; World Health Organization, WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illness, 2012, apps.who.int/iris/bitstream/handle/10665/44540/9789241548120_Guidelines.pdf;jsessionid=196A5F9B0C8A8F83 0A79E845949983D2?sequence=1. 7 Section III See note 14 (One-Paragraph Letter); Russell Portenoy, Kathleen Foley, “Chronic use of opioid analgesics in nonmalignant pain: report of 38 cases.”, Pain no.25 (1986):171-86. Two individuals with strong ties to the opioid industry, Russell Portenoy and Kathleen Foley, also wrote an academic article that supported this claim. This article has served as a reference for doctors, patient groups, and other pain studies that helped spread this falsity. 26 World Health Organization, “Ensuring Balance,” at 15. 27 U.S. Department of Health and Human Services, National Institute of Health, National Institute on Drug Abuse, Prescription Drugs: Abuse and Addiction, October 2011, at 13, www.documentcloud.org/documents/277623-nihprescription-research-series#document/p13/a41513. 28 U.S. Department of Health and Human Services, National Institute of Health, National Institute on Drug Abuse National Institute on Drug Abuse, Opioid Overdose Crisis, last modified January 2019, (accessed Feb. 27, 2019) https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis#eight. 25 8 Section III World Health Organization, “Ensuring Balance,” at 16. World Health Organization, “Ensuring Balance,” at 28-29. 31 World Health Organization, “Ensuring Balance,” at 3. 32 Alex Smith, “Opioids Don’t Beat Other Medications for Chronic Pain,” NPR, March 6, 2018, www.npr.org/sections/health-shots/2018/03/06/590837914/opioids-dont-beat-other-medications-for-chronic-pain; Deborah Dowell, MD, Tamara M. Haegerich, PhD, Roger Chou, MD, “CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016,” Maternal Mortality Weekly Report, 65, (2016):1–49, 29 30 9 Section III https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm. In 2016, the CDC further debunked the myth that opioids are effective for chronic non-cancer pain with its release of “Guidelines For Prescribing Opioids For Chronic Pain,” which recommends that doctors exercise caution when prescribing opioids for chronic pain. 33 World Health Organization, “Ensuring Balance,” at 29-30. 34 Amy S. B. Bohnert, Marcia Valenstein, Matthew J. Bair, “Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths,” Journal of the American Medical Association 305(13) (2011): 1315-1321, https://jamanetwork.com/journals/jama/fullarticle/896182. 10 Section III World Health Organization, “Persisting Pain in Children,” at 56. World Health Organization, “Persisting Pain in Children,” at 40. 37 Zack Budryk, “Pennsylvania attorney general sues Purdue Pharma over opioid epidemic,” The Hill, May 14, 2019, https://thehill.com/homenews/state-watch/443650-pennsylvania-attorney-general-sues-purdue-pharma-over-opioidepidemic). 38 Centers for Disease Control and Prevention, Calculating Total Daily Dose of Opioids for Safer Dosage, 2016, (accessed on Sept. 4, 2018) www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf. In 2016, the CDC released its own guidance called, “Calculating Total Daily Dose of Opioids for Safer Dosage.” The CDC noted that, among chronic pain patients at the Veterans Health Administration (VHA) who were receiving opioids from 2004 to 2009, the average prescribed dosage of patients who died of opioid overdoses was 98 MME per day. Comparatively, patients only prescribed 48 MME per day did not die from overdoses. Based on this study, and other similar statistics, the VHA goes on to recommend that providers “[a]void or carefully justify increasing dosages to ≥90 MM/day.” 35 36 11 Section III World Health Organization, “Persisting Pain in Children,” at 138; Beth Mole, “With a 10-Day Supply of Opioids, 1 in 5 Become Long-Term Users,” Ars Technica, March 18, 2017, arstechnica.com/science/2017/03/with-a-10-daysupply-of-opioids-1-in-5-become-long-term-users/.When patients receive an opioid prescription for a five-day supply, their chances of still being on opioids a year later are about ten percent. When they receive a ten-day supply, that chance leaps up to 20 percent. 40 World Health Organization, “Persisting Pain in Children,” at 85-86. 41 World Health Organization, “Persisting Pain in Children,” at 10. 42 World Health Organization, “Persisting Pain in Children,” at 14. 39 12 Section III & IV Purdue Pharma, “1996-2002 Budget Plans,” reports available by Kaiser Health News, June 13, 2018, khn.org/news/purdue-and-the-oxycontin-files/. 44 World Health Organization, “Persisting Pain in Children,” at 37-41. 43 13 Figure 2 FIGURE 2: INFLUENTIAL ORGANIZATIONS AND PEOPLE WITH TIES T0 THE INDUSTRY Follow the money and the influence. PURDUE 8: THE WHII American Pain\ Society] lntl. Association for\ the Study of . Pain 4 r? Russell Portenoy a Willem Scholten Richard Payne A /Kathleen Foley lntl. Children's Palliative Care etwork Mayday Fund lntl. Association for U5 Cancer Pain Hospice 8. Palliative Care Relief Committee (IAH PC) Open Society Foundations -Delphi Study Report Ensuring Balance Persisting Pain in Children WHO Center at University of Wisconsin ACMP Framework 14 Table 1 45 American Pain Society, Your Portal to the Global World of Pain, last modified 2019, (accessed May 19, 2019) http://americanpainsociety.org/about-us/iasp/overview; Use of Chronic Opioid Therapy in Chronic Noncancer Pain; The American Pain Society in Conjunction with the American Academy of Pain Medicine, Use of Chronic Opioid Therapy in Chronic Noncancer Pain, January 23, 2009, http://americanpainsociety.org/uploads/education/guidelines/chronic-opioid-therapy-cncp.pdf. 46 U.S. Senate Homeland Security & Government Affairs Committee, Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups, Minority Report, 115th Cong. (Feb. 12, 2018) www.hsgac.senate.gov/imo/media/doc/REPORT-Fueling%20an%20EpidemicExposing%20the%20Financial%20Ties%20Between%20Opioid%20Manufacturers%20and%20Third%20Party%2 0Advocacy%20Groups.pdf). 47 Id. 48 American Pain Society, American Pain Society Awarded Research Grant from Mayday Fund, May 31, 2016, americanpainsociety.org/about-us/press-room/american-pain-society-awarded-research-grant-from-mayday-fund. 15 Table 1 49 American Chronic Pain Association, Advisory Board Members, (accessed Sept. 5, 2018) www.theacpa.org/aboutus/advisory-board/; Dworkin et al, “Interventional Management of Neuropathic Pain: NeuPSIG Recommendations,” PAIN 54, no. 11, (2013): 2249-61, rsds.org/wp-content/uploads/2015/02/interventional-magtneuropathic-pain.pdf; John Fauber, “IOM and COI: Painful Disclosures?,” Pain Management, MedPage Today, June 25, 2014, https://www.medpagetoday.com/painmanagement/painmanagement/46482. 50 International Association for the Study of Pain. IASP 2008 Annual Report, at s3.amazonaws.com/rdcmsiasp/files/production/public/Content/ContentFolders/MembersOnly2/Annual_Report_2008_low_res_Final_082409 .pdf; International Association for the Study of Pain, International Association for the Study of Pain 2009 Annual Report, s3.amazonaws.com/rdcmsiasp/files/production/public/Content/ContentFolders/AboutIASP/IASPAnnualReport_2009.pdf. 51 International Association for the Study of Pain, Disclosures, (accessed Sept. 4, 2018) www.iasppain.org/Leadership/Disclosures. Janssen is a unit of Johnson & Johnson; Teva Pharmaceutical Industries is another drug manufacturer. 52 World Health Organization, “Ensuring Balance,” at iii. World Health Organization, “Persisting Pain in Children,” at 6. 53 World Health Organization, “Persisting Pain in Children,” at 76,121,123,148-155. 16 Table 1 54 The Mayday Fund, Mayday Fellows, (accessed on Sept. 4, 2018) www.maydayfund.org/mayday-fellows/. Christopher James,“Dr. Brian Schmidt Named to the Mayday Pain and Society Fellowship for 2013-2014,” New York University Dentistry, Sept. 3, 2013, dental.nyu.edu/aboutus/news/articles/276.html. 56 See note 55 (New York University Dentistry); Charles Ornstein and Tracy Weber, “Patient advocacy group funded by success of painkiller drugs, probe finds,” Health and Science, The Washington Post, December 23, 2011, https://www.washingtonpost.com/national/health-science/patient-advocacy-group-funded-by-success-of-painkillerdrugs-probe-finds/2011/12/20/gIQAgvczDP_story.html?utm_term=.07fba2c85c3e. 57 Charles Ornstein, Tracy Weber, “American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics,” ProPublica, May 8, 2012, online at www.propublica.org/article/senate-panel-investigatesdrug-company-ties-to-pain-groups. 58 Tracy Weber and Charles Ornstein,“Two Leaders in Pain Treatment Have Long Ties to Drug Industry,” ProPublica, Dec. 23, 2011, www.propublica.org/article/two-leaders-in-pain-treatment-have-long-ties-to-drug-industry. 59 Id.; Roger Parloff, “Nation’s Top Pain Doctors Face Scores of Opioid Lawsuits,” Yahoo Finance, April 3, 2018, finance.yahoo.com/news/nations-top-pain-doctors-face-scores-opioid-lawsuits-160906369.html. 60 See note 55 (New York University Dentistry); Senate Committee on the Judiciary, “Testimony of James Campbell, M.D., 110th Congress,” July 31, 2007, www.judiciary.senate.gov/imo/media/doc/Campbell%20Testimony%20073107.pdf. 55 17 Table 1 Sarah Kliff, “The Opioid Crisis Changed How Doctors Think About Pain,” Vox, June 5, 2017, www.vox.com/2017/6/5/15111936/opioid-crisis-pain-west-virginia. 62 See note 48 (Awarded Research Grant). 63 World Health Organization, “Persisting Pain in Children,” at 6. 64 International Association for Hospice & Palliative Care, Attachment to Form 990 for International Association for Hospice & Palliative Care, 2010, https://hospicecare.com/uploads/2015/6/990%20Form.pdf; International Association for Hospice & Palliative Care, Attachment to Form 990 for International Association for Hospice & Palliative Care, 2014, https://hospicecare.com/uploads/2015/6/990%20Form.pdf. 65 Attachment to Form 990 for International Association for Hospice & Palliative Care, 2008, https://hospicecare.com/uploads/2011/8/2008-form-990-ez.pdf. 66 International Association for Hospice & Palliative Care, “News On-line “Promoting Hospice and Palliative Care Worldwide” (accessed on May 17, 2019) https://hospicecare.com/newsletter2005/jan05/. 61 18 Table 1 International Association for Hospice & Palliative Care, “Bio,” “Executive Director Liliana de Lima, MHA,” 2019, (accessed May 21, 2019) https://hospicecare.com/bio/liliana-de-lima/. 68 World Health Organization, “WHO Normative Guidelines,” at 45; World Health Organization, “Ensuring Balance,” at 63, 66; World Health Organization, “Persisting Pain in Children,” at 6. 69 See note 65 (Form 990, 2008); World Health Organization, Access to Controlled Medications Programme Framework, Feb. 2007, at 21, 24, www.who.int/medicines/areas/quality_safety/Framework_ACMP_withcover.pdf. 70 Guidestar, “United States Cancer Pain Relief Committee Inc.” (accessed on Sept. 4, 2018) www.guidestar.org/profile/39-1573802; Charles Lane, “Are Restrictions on Opioids a Threat to Human Rights?,” Opinion, Washington Post, April 30, 2018, www.washingtonpost.com/opinions/are-restrictions-on-opioids-athreat-to-human-rights/2018/04/30/42c7ac32-4c86-11e8-af46b1d6dc0d9bfe_story.html?utm_term=.7abdde53458f. 71 Id.; “Form 990 for US Cancer Pain Relief Committee Inc.,” ProPublica, 2016, (accessed December 2018) projects.propublica.org/nonprofits/organizations/391573802. 72 See note 71 (Form 990 for US Cancer). 67 19 Table 1 73 See note 65 (Form 990, 2008). World Health Organization, “Persisting Pain in Children,” at 6. 75 International Children’s Palliative Care Network, “ICPCN’s Advocacy Director Talks About Challenges Around Opioid Availability for Children in Sub Saharan Africa,” (Sept. 29, 2017) www.icpcn.org/icpcns-advocacydirector-talks-challenge-around-availability-opioids-children-serious-illnesses-sub-sahara-africa/. 76 International Children’s Palliative Care Network, Finance and Sustainability (online at www.icpcn.org/ourwork/finance-and-sustainability/) (accessed on Sept. 4, 2018). 77 European Association for Palliative Care, “12th Congress of the European Association for Palliative Care,” May 1821, 2011, https://www.eapcnet.eu/Portals/0/adam/Content/KOFQ29AKX0i8oaDwFxdJw/Text/Lisbon%20Abstracts%20.pdf; European Association for Palliative Care, “EAPC 2013 Final Program,” May 30-June 2, 2013, https://www.eapcnet.eu/Portals/0/adam/Content/QSmeATO__0Cdo_rsyKK5RA/Text/prague%20programme%20. pdf. 78 World Health Organization, “Persisting Pain in Children,” at 6. 74 20 Table 1 79 80 See note 76 (Finance and Sustainability); see note 65 (Form 990, 2008). World Health Organization, “Persisting Pain in Children,” at 6; World Health Organization, “Ensuring Balance,” at iii. 21 Table 2 81 See note 55 (New York University Dentistry). Patrick Radden Keefe, “The Family that Built an Empire of Pain,” The New Yorker, October 30, 2017, www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain; see note 59 (Top Pain Doctors); see note 71 (Form 990 for US Cancer); Practical Pain Management (PPM), “About Russell Portenoy, MD,” (accessed on Sept. 4, 2018) www.practicalpainmanagement.com/author/16278/portenoy. 83 See note 82 (About Russell Portenoy); see note 14 (One-Paragraph Letter); see note 25 (Portenoy, Foley). 84 See note 82 (About Russell Portenoy); see note 59 (Top Pain Doctors). 85 Department of Essential Medicines and Pharmaceutical Policies Health Systems and Services, World Health Organization, Access to Controlled Medications Programme Component: Developing WHO Clinical Guidelines on Pain Treatment, April 2012, https://www.who.int/medicines/areas/quality_safety/ACMP_BrNote_PainGLs_EN_Apr2012.pdf; World Health Organization, “Persisting Pain in Children,” at 6; World Health Organization, “Ensuring Balance,” at iii, 62. 82 22 Table 2 World Health Organization, “Persisting Pain in Children,” at 142. World Health Organization, “Persisting Pain in Children,” at 142. 88 See note 2 (OxyContin Goes Global); Willem Scholten,“Opioid overdose death epidemic sensationalised at the cost of pain patients,” European Association for Palliative Care, March 2, 2016, https://eapcnet.wordpress.com/2016/03/02/opioid-overdose-death-epidemic-sensationalised-at-the-cost-of-painpatients/. 89 Willem Scholten Consultancy, Presentation at Lisbon Addictions 2015, “Are the Substance Lists of the International Drug Conventions Legitimate?,” Sept. 23-25, 2015, www.lisbonaddictions.eu/attachements.cfm/att_242876_EN_11h00_05_r2_25_Willem%20Scholten%20LisbonAd d2015%20Session23%20ScholtenW.pdf); see note 2 (OxyContin Goes Global). 90 See note 89 (Presentation at Lisbon). 86 87 23 Table 2 91 See note 22 (Federal Pain Panel). See note 71 (Form 990 for U.S. Cancer); see note 55 (New York University Dentistry); Samantha Kupferman, Physicians for Human Rights, “For Immediate Release: Physicians for Human Rights Welcomes Dr. Kathleen Foley to its Board of Directors,” June 29, 2015, physiciansforhumanrights.org/press/press-releases/physicians-forhuman-rights-welcomes-dr-kathleen-foley-to-its-board-of-directors.html; Kathleen Foley, Memorial Sloan Kettering Cancer Center, Our Physicias & Nurses: At Work, “At Work: Neurologist Kathleen Foley,” (accessed Sept. 4, 2018) www.mskcc.org/experience/physicians-at-work/kathleen-foley-work. In an article for Memorial Sloan Kettering Cancer Center, where Kathleen Foley has served in various roles, she discusses running the Project on Death in America for the Open Society Foundations. Foley says: “The [Project on Death in America] also recognized that we had to focus on the development of leaders and palliative care experts if we were going to be able to change the care of patients. We created leadership programs for physicians, nurses, and social workers. For example, over the years, we awarded grants to 87 faculty scholars, many of whom now hold positions at leading academic institutions around the country, including at Memorial Sloan Kettering Cancer Center. These professionals were to be the Trojan horses within our institutions to lead pain and palliative care services.” As previously discussed, the effort to educate and fund “Trojan horses” was a pillar of opioid manufacturers’ strategy to increase their sales. 93 See note 60 (Testimony of James Campbell); Charles Ornstein, Tracy Weber, “American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics,” ProPublica, May 8, 2012, www.propublica.org/article/senate-panel-investigates-drug-company-ties-to-pain-groups. 94 See note 60 (Testimony of James Campbell); see note 57 (Senators Launch Investigation). 95 World Health Organization, “Persisting Pain in Children,” at 6, 142. 96 World Health Organization, “WHO Normative Guidelines on Pain Management,”at 35. 92 24 Table 2 International Association for Hospice & Palliative Care, “Kathleen Foley,” last modified 2019, (accessed May 16, 2019) https://hospicecare.com/bio/kathleen-foley/. 98 Harvard University, “Curriculum Vitae of Richard Payne,” 2014, (accessed Sept. 4, 2018) hms.harvard.edu/sites/default/files/assets/Sites/Alumni/Files/2014CandidateCV_Payne.pdf; see note 71 (Form 990 for U.S. Cancer). 99 Id. 100 See note 21 (UW a Force); World Health Organization, “Access to Controlled Medications Programme Framework,” at 7, 21, 24. 101 See note 21 (UW a Force). 97 25 Table 3 102 See note 69 (Access to Controlled Medications). See note 21 (UW a Force). 104 See note 22 (WHO Normative Guidelines). 105 Id. 103 26 Table 3 World Health Organization, “Access to Controlled Medications Programme Framework,” at 7, 21, 24. World Health Organization, “Persisting Pain in Children,” at 66. 108 World Health Organization, “Persisting Pain in Children,” at 144. 109 European Association for Palliative Care, “The Official Journals of the EAPC,” (accessed on Sept. 4, 2018) www.eapcnet.eu/Themes/Resources/EJPCandPalliativeMedicine.aspx; European Association for Palliative Care, “EAPC Task Force on the Development of Palliative Care in Europe: Autumn 2004,” (accessed on Sept. 4, 2018) www.researchgate.net/profile/Carlos_Centeno/publication/282493927_Latest_report_from_the_EAPC_Task_Forc e_on_the_Development_of_Palliative_Care_in_Europe/links/5684031c08ae1e63f1f1c2b6/Latest-report-from-theEAPC-Task-Force-on-the-Development-of-Palliative-Care-in-Europe.pdf. 106 107 27 Table 3 & Section V 110 See note 49 (Advisory Board Members); see note 49 (Interventional Management); see note 46 (Fueling an Epidemic). 111 Journal of Pain & Palliative Care Pharmacotherapy, “Editorial Board,” (accessed on Sept. 4, 2018) www.tandfonline.com/action/journalInformation?show=editorialBoard&journalCode=ippc20&. 112 United Nations Office on Drugs and Crime, World Drug Report 2017 Booklet 2, June 22, 2017, at 29, www.unodc.org/wdr2017/. 113 See note 32 (Guidelines for Prescribing). 114 See note 49 (Advisory Board Members); see note 49 (Interventional Management); see note 46 (Fueling an Epidemic); see note 32 (Opioids Don’t Beat). The Clinical Journal of Pain, “About the Journal,” (accessed on May 20, 2019) online at https://journals.lww.com/clinicalpain/Pages/aboutthejournal.aspx. One of the other two references cited to support the claim that opioids are used effectively for chronic pain is an article published in the Clinical Journal of Pain. The Editor-in-Chief of that journal is Dennis Turk, the Chairman of the American Chronic Pain Association and a past president of the American Pain Society, who has received personal fees from opioid manufacturers. 28 Section V Dora H. Lin, Eleanor Lucas, Irene B. Murimi, et al., “Financial Conflicts of Interest and the Centers for Disease Control and Prevention’s 2016 Guideline for Prescribing Opioids for Chronic Pain,” JAMA Intern Medicine 177, no.3 (2017):427–428, jamanetwork.com/journals/jamainternalmedicine/fullarticle/2598092. 116 United Nations Office on Drugs and Crime, “World Drug Report 2017 Booklet 2” at page 30. 117 World Health Organization, Scoping Document for WHO Guidelines for the Pharmacological Treatment of Persisting Pain in Adults with Medical Illnesses, 2012, www.who.int/medicines/areas/quality_safety/Scoping_WHO_GLs_PersistPainAdults_webversion.pdf. 118 World Health Organization, “Scoping Document,” at pg. 15. The WHO specifically announced: “Various donor organizations who contributed financially to the development of the WHO Guidelines on the pharmacological treatment of persisting pain in children with medical illnesses will be invited to contribute again and so will other organizations be invited. The guidelines will be developed with the expertise of many specialists on an individual basis. However, these specialists will be identified with the help of NGOs in official relations with WHO, like the International Association for the Study of Pain (IASP), the 115 29 Section V & VI International Association for Hospice and Palliative Care (IAHPC), the Federation Internationale Pharmaceutique (FIP) and the Union for International Cancer Control (UICC). Other NGOs may be involved as needed.” 119 World Health Organization, WHO Guidelines for the Pharmacological and Radiotherapeutic Management of Cancer Pain in Adults and Adolescents, 2018, https://apps.who.int/iris/bitstream/handle/10665/279700/9789241550390-eng.pdf?ua=1; 30 Appendix 120 See note 3 (About Purdue Pharma). Id. 122 Id. 123 Paul Schott, “Sacklers Quit Board Amid Shifts for OxyContin Maker,” AP News, April 7, 2019, https://www.apnews.com/7b14f628aceb4849b957f7aec489c8f8. 124 See note 2 (OxyContin Goes Global). 125 See note 2 (OxyContin Goes Global); see note 5 (Secret Trove). Purdue Pharma L.P. previously partnered with Abbot Laboratories, which is now better known as AbbVie, to market OxyContin to physicians. 126 See note 5 (Secret Trove); see note 3 (Description of Hell). 127 Carolyn Y. Johnson, “Opioid Prescriptions Fell 10 Percent Last Year, Study Says,” Washington Post, April 19, 2018, https://www.washingtonpost.com/news/wonk/wp/2018/04/19/opioid-prescriptions-fell-10-percent-last-year-studysays/?utm_term=.7349cea9b06b. 121 31 Appendix Puja Seth, Rose A. Rudd, Rita K. Noonan, Tamara M. Haegerich, “Quantifying the Epidemic of Prescription Opioid Overdose Deaths,” American Journal of Public Health 108, 2017: 500-502, ajph.aphapublications.org/doi/10.2105/AJPH.2017.304265; Health and Human and Services, National Institute Health, National Institute on Drug Abuse, Overdose Death Rates, last modified January 2019, (accessed on Sept. 5, 2018) www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. 129 Id. 130 Nate Raymond,“Missouri Sues Opioid Manufacturers, Joining Two Other U.S. States,” Reuters, June 21, 2017, www.reuters.com/article/us-missouri-opioids-idUSKBN19C1VK); German Lopez, “The Growing Number of Lawsuits Against Opioid Companies, Explained,” Vox, May 15, 2018, www.vox.com/policy-andpolitics/2017/6/7/15724054/opioid-epidemic-lawsuits-purdue-oxycontin. It should be noted that Purdue was not alone. In the U.S., the entire opioid manufacturer industry successfully took advantage of prominent doctors and patient advocacy organizations. Cephalon and Janssen are also both currently being sued by multiple U.S. states for deceptive practices related to their marketing of opioids. 131 See note 9 (Sackler Embraced Plan); Chris McGreal, “Rudy Giuliani Won Deal for OxyContin Maker to Continue Sales of Drug Behind Opioid Deaths,” The Guardian, May 22, 2018, www.theguardian.com/usnews/2018/may/22/rudy-giuliani-opioid-epidemic-oxycontin-purdue-pharma. 132 See note 82 (Empire of Pain); see note 9 (Sackler Embraced Plan). 133 See note 9 (Sackler Embraced Plan). 134 See note 130; see note 1 (New York Sues); Anthony Izaguirre, Geoff Mulvihill, “5 More States Sue Pudue Pharma and Other Drugmakers Over the Opioid Epidemic,” Time, May 16, 2019, http://time.com/5590547/states-suepurdue-pharma-opioid-epidemic/. 128 32 Appendix Martha Bebinger, Christine Willmsen, “Lawsuit Details How the Sacklers, Family Behind OxyContin, Made More than $4 billion,” WBUR, February 20, 2019, https://www.wbur.org/commonhealth/2019/01/31/sacklers-purdueoxycontin-billions. 136 Chris Kenning, Beth Warren, “Court records may detail how opioid company downplayed OxyContin risks,” Louisville Courier Journal, Dec. 14, 2018, https://www.courierjournal.com/story/news/local/2018/12/14/kentucky-court-rules-unseal-purdue-pharma-opioidrecords/2310160002/. 137 See note 130 (Growing Number of Lawsuits). It should be noted, again, that Purdue Pharma was not alone. The lawsuit in Ohio accuses Purdue Pharma, Endo, Teva Pharmaceutical industries, Johnson & Johnson, and Allergan of all having a hand in false advertising. 135 33 Appendix APPENDIX B: LETTER TO THE WORLD HEALTH ORGANIZATION FROM OONORESS ?anges-ea of the i?rtiteit ?tatee I?aaltittgtott. Etta? 211515 Hayli?lT Dr. Margaret Chart Director-General World Health Organization Area as Appia 20 12? Geneva 2? Switzerland Dear Dr. Chan: We write to warn the intemational communin of the deceptive and dangerous practices of Mundiphamta [ntemational?an amt of' Purdue Pharmaceuticals. The greed and recklessness of one cornpang.r and its partners helped spark a public health crisis in the United States that will talte generations to repair. We urge the World Health Organization to do everything in its power to avoid allowing the same people to begin a worldwide opioid epidemic. Please learn ?'otn our experience and do not allow Mundipharma to carry on Purdue's deadly legacy on a global stage. Mundiphanna International is a network ot'pharmaceutical companies owned by the Saekler family. The also own and operate Purdue Pharmaceuticals, the privately held company that developed and marketed 0aytl'ontin.' Internal documents revealed in court proceedings tell us that since the early development of ?ayContin, Purdue was aware ofthe high risk of addiction it carried.1 Combined 1with the misleading and aggressive marketing of the drug by its partner1 Abbott Laboratoriesl Purdue began the opioid crisis that has devastated American communities since the end ofthe [9905. Today, Mundipharma is using than}.r ot'the same deceptive and reckless practices to sell abroad.? UsyContin was approved by the LLS. Food and Drug Administration in 1995. Though executives at Purdue were aware that their dosing recommendations were ineiTeetitre for many patientsr and that the formulation and dosing raised the risk ofaddietion, the},- advertised OxyContin as a. solution for day-to-day pain.5 Purdue and its marketing partner Abbott used The Men at the Center ofthe Secret Mamie Fries, Stat News {May- ll, ti} {online at 2 ?You Want a Description of?e?? ?y?'onlin '5 .i'E?Hottr Predict-rt, Los Angeles Times {May 5.. 2015] [online at 3 Secret Trove Revered: Hold to Moire Mamie tl' Blockbuster. Stat News (Sep. 12, 2016} [online at {Hg-Contra Goes Global?"We 're Gobi Just Los Angeles Times (Dec. I8. seats} {online at: See note 2. ?In?ll! {it PAPER 34 Appendix gifts and Free meals to develop relationships with physicians, who would then prescribe the painkiller to patients with ordinary pains, rather than the severe, long~term pain associated with end-stage cancer.El Purdue's efforts were effective: at their height, 1{itirthontin sales reached $3 biliion a year. Meanwhile, cases of opioid-related substance use disorder skyrocketed. By emergency room visits related to prescription drugs reached LI million cases, with opioid pain relievers, and especialiy ?nyContin, being the most prominent cause for visits and Fatalities.I People were dying. Moreover, as the rate of prescription opioid use and related overdoses rose, increased demand also spilled into the illicit drug trade.9 The enormous market for opioids created in the Welt: of the DsyContin boom, combined with the much lower cost of heroin compared with prescription medications, meant an explosion in heroin use and dramatic increase in the rate of overdoses. As many as 30 percent of heroin users started out using prescription opioids. Today, in spite of intensive efforts to address this crisis, the rate of overdose deaths continues to rise. lrlill?l? alone, more than people died as a result of opioid overdoses in the United States. A major piece of the current LLS. strategy to address the opioid epidemic is to provide physicians and patients with information about the risks associated with opioids, as well as effective alternatives For pain management collaboration between prescribers and lawmakers, prescriptions for DsyContin in the US. have dropped neariy d?'i?u since 21]] In response to the growing scrutiny and diminishing LLS- sales, the Sacklers have simply moved on. Do December 13, the Los Angeles Times published an extremely troubling report detailing how in spite ol' the scores of lawsuits against Purdue for its role in the 1.1.5. opioid crisis, and tens of thousands ofoverdose deaths, Mundiphanna now aggressively markets DsyContin '5 See note 3. See note 2. a Food and Drug Adminisoation, Tinreiine ofSeiecied FDA Activities Signi?cant Events Addressing Dpior'd Misuse e5: airbase {Jam I [online at 1' Heroin Deaths Surpass Grin Homicides for rite First Time. CDC Doro Snows, Washington Post (Dec. B, It" [online at 1 he Hospitalizations Among Teens?lr Opioid Poisoning: increase. Study Shows, Teen Vogue (Feb. 13, 201?) {online at hospimlieationoteen-story}. White House. Continued Rise in Gpioid Stet-dose Deaths in EMS Snot-ts Urgent Needfor Treatment (Dec. 3, E?id} {online at pj?'reeil? Ii-I'i Ef??ieonti 5shows-urgent-need-treatment}. See note 4. 35 Appendix internationttl1y.13 In feet. Mundiphanna uses many of the same taetics that caused the opioid epidemic to ?ourish in the U.S., though now in countries with far fewer resources to devote to the fallout. In some places, Mundiphanna companies hold ?training seminars." where doctors are encouraged to orerloolt their concerns about opioids and prescribe painkillers for chronic pain. Some Mundiphunna materials have attempted to downplay the risk ofarldiet?iom recalling Purdue's early ClayContin marketing in the Those marketing materials eventually led to federal drug charges and a $635 millionjudgment against Purdue. Mundiphamra also brings Ameriesn doctors to other countries to promote the use of opioid painkillers to local physicians. This. too1 was a common practice by Purdue to push DayContin in the U.S. The international health community has a rare opportunity to see the Future. Though the rate ol? opioid use disorder remains relatively lot--r outside ofthe United States. that can change rapidly. The rate is liltely to rise ii? events follow the same pattern as in the United States, starting with the irresponsible?and potentially criminal?marketing of prescription opioids. From 1999 to 21114, the rate of opioid-related overdose deaths in the United States nearly quad mpled." Dpiotd use disorder is on the rise globally now?current European rates are similar to rates in the United States in the early Z?il?s, and the has struggled to address rising dependenee on Tramadol in at least eight countries.' We urge the WHO to team from our experience and rein in this reckless and dangerous behavior while there is still time. Do not allow Purdue to walk away From the tragedy they have in?icted on countless American families simply to find new markets and new yietirns elsewhere. Sincerely, Ni. we?: Maori ath rine Clark 'Hal Rogers Member ol? lCongress Member of Congress [3 Id. Del-emmenr of? Health and Human Serviees. The ?pjor'd Epidemier By: the Nominees {Jun EDIE) [oniine at: 5 Eepdf). '5 See note I ?piot'a's: Sierra Leone Newest Politic Health El?Engrl'qlr Al Jazeera (Feb. Isl. 'E?l {online at liopioids-sierta-leans-newest- public-imalthvemergency-i 36 Appendix Thain-n: E. Deulch Member at" Cengress . rijeivn Member of Cengress ??zz ?ie?LgM Marcy Kept 1Iiipiillinm R. Keeling Me min-er of Cengress Member of $.me Ann McLenc Kuslcr Member Ste en F. Member Can are emee McGeveh Tim Ryan a ember of {Zen 311355 Member of Cami Shea-Porter an D. an Member ei?Cengress Member erCungress 37 Appendix World Health Organization, “WHO Normative Guidelines,” at 44-47. See note 109 (Official Journals); Carlos Centeno, “Latest report from the EAPC Task Force on the Development of Palliative Care in Europe,” European Association for Palliative Care,13, 2006: 149-151, www.researchgate.net/profile/Carlos_Centeno/publication/282493927_Latest_report_from_the_EAPC_Task_Forc e_on_the_Development_of_Palliative_Care_in_Europe/links/5684031c08ae1e63f1f1c2b6/Latest-report-from-theEAPC-Task-Force-on-the-Development-of-Palliative-Care-in-Europe.pdf. 140 International Association for the Study of Pain, “Membership,” “Chapters,” last modified 2018, (accessed May 19, 2019) https://www.iasp-pain.org/EFIC. 141 Union for International Cancer Control, “Our Partners,” (accessed on Sep. 25, 2018) www.uicc.org/who-wework/partners/our-partners. 142 World Institute of Pain, “8th World Congress of the World Institute of Pain, Industry Support and Exhibition Prospectus,” May 20-23, 2016, at 17, wip2016.kenes.com/Documents/WIP%202016%20Prospectus_non%20priced.pdf. 143 International Association for the Study of Pain, “IASP Day at FEDELAT Congress Extends Latin America Outreach,” Nov. 15, 2017, (accessed May 20, 2019) https://www.iasppain.org/PublicationsNews/NewsDetail.aspx?ItemNumber=6866. 138 139 38