July 24, 2014 Elyse I. Summers, JD President and Chief Executive Officer Association for the Accreditation of Human Research Protection Programs 2301 M Street, NW, Suite 500 Washington D.C. 20037 Re: Additional Conflicts-of-Interest Involving AAHRPP and Pfizer Dear Ms. Summers: As documented in my letters of July 16 and July 21, AAHRPP is enmeshed in multiple conflicts-of-interest as it proceeds with its circumscribed “review” of current research policies and practices at the University of Minnesota. In my previous letter, I described the conflicts-of-interests produced by having three former Pfizer senior executives on AAHRPP’s Board of Directors. The presence of these former Pfizer executives on AAHRPP’s Board is a matter of great concern because your organization has accredited Pfizer, numerous individuals chairing or staffing research protections programs receive funding from Pfizer (including a former IRB Chair at the University of Minnesota), and these research protections programs review and approve clinical studies sponsored by Pfizer. These very research protection programs are accredited by AAHRPP. Noting that one of the three AAHRPP directors is at present a Vice President at Novartis, the conflicts-of-interest I have identified are not restricted to the interconnections among AAHRPP, Pfizer, institutions accredited by AAHRPP, and the clinical studies reviewed by those research protection programs. To date you have failed to answer my questions, provide me with AAHRPP’s conflict-of-interest policy, and disclose conflicts-of-interest statements completed by past and present AAHRPP directors, members of the Accreditation Council, staff members, and site visitors. Once again, I note that AAHRPP is failing to meet the conflict-of-interest standard that it applies to organizations it accredits. As I await your response, I want to review additional financial conflicts-of-interest connecting AAHRPP to Pfizer. In 2010, the Association for the Accreditation of Human Research Protections Programs received $35,173 from Pfizer. Pfizer was accredited by AAHRPP in 2009 and reaccredited in 2013. AAHRPP therefore accepted non-accreditation-related funding from at least one company that you and your co-workers claim to have accredited in an independent and unbiased manner. I ask that you explain why AAHRPP accepted funding from a corporation that AAHRPP also accredits. Such financial transactions risk compromising the integrity of AAHRPP’s accreditation process.

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I wish to draw your attention to an individual who worked as a “market researcher fellow” at AAHRPP while employed by Pfizer. (It is unclear whether this individual’s appointment at AAHRPP is connected to the $35,173 AAHRPP received from Pfizer.) While at AAHRPP, Pfizer manager Ying Song was responsible for developing “the accreditation development plan for China” and creating “a business model to persuade and increase the number of sites in China to seek accreditation.” Why did a Pfizer employee create AAHRPP’s business plan for increasing AAHRPP’s market share in China? Did this Pfizer employee’s work at AAHRPP comply with your organization’s conflict-of-interest policy? Have other Pfizer employees or employees of other pharmaceutical companies helped advance AAHRPP’s economic interests? Please address whether AAHRPP or AAHRPP’s former President, Marjorie Speers, received any funds from Pfizer for her work editing the text, Reviewing Clinical Trials: A Guide for the Ethics Committee. Ms. Speers is listed as one of the guide’s two editors. According to the guide’s preface, the “idea” for the manual “came from Pfizer,” the “general project layout protocol was accepted by Pfizer,” and Pfizer provided a “nonbinding grant for its development.” Marc Wilenzick, now an AAHRPP board member and at the time Pfizer’s Chief Compliance Counsel, served as Pfizer’s chief representative during preparation of the guide. Acknowledging that the Clinical Trials Centre at the University of Hong Kong administered the grant Pfizer provided for development of the guide, did AAHRPP, Ms. Speers, or anyone else associated with AAHRPP receive compensation from Pfizer as a result of assisting with the preparation of this guidebook? In November 2012, AAHRPP and Manipal Hospital Bangalore co-hosted a conference sponsored by Pfizer. (The event took place less than a year after AAHRPP accredited Manipal Hospital.) As in the case of the guidebook, the grant went from Pfizer to Manipal Hospital. I am concerned that AAHRPP is organizing conferences funded by Pfizer. Were expenses related to holding the event, including speakers’ fees and other costs, paid by Pfizer? Did AAHRPP, AAHRPP executives or staff members, or other individuals associated with AAHRPP receive any funds directly from Pfizer or indirectly via Manipal Hospital? Why did AAHRPP co-host an event with an organization that it accredits and have this event funded by Pfizer? In June 2013, AAHRPP partnered with Medanta and Medanta Duke Research Institute and held a conference in New Delhi. The event was funded by a grant from Pfizer. Were speakers’ fees and other conference-related expenses paid with funds provided by Pfizer? Did AAHRPP receive any payments directly from Pfizer or indirectly from Medanta or Medanta Duke Research Institute? Again, why did AAHRPP co-host an event funded by Pfizer? How has your organization addressed the conflicts-of-interest produced by such financial arrangements? Are there additional guidebooks, conferences, or other initiatives in which AAHRPP had a relationship with an organization that accepted funds from Pfizer? If so, were any funds transferred from Pfizer to AAHRPP’s partners and then from AAHRPP’s partners to AAHRPP? If such transactions occurred, please disclose all relevant details. AAHRPP claims that it accredits institutions in an unbiased, independent, and transparent manner. However, three former senior Pfizer executives are AAHRPP board members. AAHRPP has been paid to accredit and re-accredit Pfizer. AAHRPP has accepted from Pfizer funding in addition to payments it has received for the service of accreditation. A Pfizer employee developed a business plan to increase

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the number of institutions willing to pay for AAHRPP’s accreditation service. Pfizer sponsored at least one guidebook co-edited by AAHRPP’s former President and CEO. Pfizer has funded at least two conferences co-organized by AAHRPP. In addition, many individuals - including Dr. David Adson here at the University of Minnesota - have accepted funding from Pfizer while also playing prominent roles within research protection programs accredited by AAHRPP. These IRB Chairs and members have reviewed and approved clinical trials sponsored by Pfizer. As a result of its ties to Pfizer - a pharmaceutical company with a history of corporate scandals that includes the Trovan study in Nigeria, payment of $430 million in criminal fines and civil penalties in 2004, and a $2.3 billion settlement for fraudulent marketing in $2009 - AAHRPP has many conflicts-of-interest. I have been unable to find any attempt by your organization to justify these various conflicts. What ethical and legal rationales does AAHRPP have for claiming that it offers unbiased, independent, transparent, and accountable accreditation services when your organization is tangled in multiple conflicts-of-interest? Yours sincerely,

Leigh Turner, PhD Associate Professor University of Minnesota Center for Bioethics cc: Arne H. Carlson, Former Governor of Minnesota

Susan Berry, M.D., Chair, IRB Executive Committee, University of Minnesota Michael Carome, M.D., Director, Health Research Group, Public Citizen

Debbie Dykhuis, Executive Director, Human Research Protection Program, University of Minnesota Carl Elliott, M.D., Ph.D., Professor, University of Minnesota Center for Bioethics Barbara Entwisle, Ph.D., Vice Chancellor for Research, University of North Carolina at Chapel Hill and Director, AAHRPP Brian Herman, Ph.D., Vice President for Research, University of Minnesota Brooks Jackson, M.D., M.B.A., Dean, University of Minnesota Medical School Eric Kaler, Ph.D., President, University of Minnesota Trudo Lemmens, LL.M., D.C.L., Associate Professor & Scholl Chair, University of Toronto Faculty of Law Bernard Lo, M.D., President, The Greenwall Foundation and Director, AAHRPP James R. Nobles, M.A., Minnesota Legislative Auditor Marsha Rappley, M.D., Dean, College of Human Medicine, Michigan State University and Director, AAAHRPP Stephanie S. Spangler, M.D., Deputy Provost, Biomedical & Health Affairs, Yale University and Director, AAHRPP Sidney Wolfe, M.D., Founder and Senior Advisor, Health Research Group, Public Citizen