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 AAHRPPs Board of Directors. The presence of these
former Pfizer executives on AAHRPPs 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 AAHRPPs 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 AAHRPPs 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 individuals 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 AAHRPPs business plan for increasing AAHRPPs market share in China? Did
this Pfizer employees work at AAHRPP comply with your organizations conflict-of-interest policy?
Have other Pfizer employees or employees of other pharmaceutical companies helped advance
AAHRPPs economic interests?

Please address whether AAHRPP or AAHRPPs 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 guides two editors. According to the guides 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 Pfizers Chief Compliance Counsel, served as Pfizers 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
AAHRPPs partners and then from AAHRPPs 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 AAHRPPs accreditation service. Pfizer sponsored at least
one guidebook co-edited by AAHRPPs 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