July 21, 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: Request for Public Disclosure of Documents Related to Conflicts-of-Interest at AAHRPP

Dear Ms. Summers:

As documented in my July 16 letter to you, AAHRPP has significant undisclosed conflicts-of-interest
as it conducts its compromised “review” of the University of Minnesota’s research protections
programs. These conflicts make it apparent that AAHRPP should not have contracted to review the
university’s research protections.

Since contacting you I have identified what appear to be additional serious conflicts-of-interest at
AAHRPP. I have discovered that three former senior executives at Pfizer are appointed to AAHRPP’s
Board of Directors. AAHRPP has accredited Pfizer’s research protections program. Many research
protections programs accredited by AAHRPP review clinical studies funded by Pfizer. The research
protections programs responsible for reviewing such trials sometimes include Institutional Review
Board Chairpersons and members that receive research grants, speakers’ fees, or other sources of
funding from Pfizer and other corporations. For example, at the University of Minnesota, Dr. David
Adson, a former IRB Chair, received payments from Pfizer, and the university’s institutional review
boards reviewed Pfizer-funded clinical trials. Dr. Stephen Olson, one of Dr. Adson’s colleagues in the
Department of Psychiatry, is one of many faculty members to have a Pfizer-funded study approved by
the University of Minnesota’s research protections program. It appears there are layers of conflicts in
which former Pfizer executives serve on AAHRPP’s Board, AAHRPP accredits research protection
programs that include individuals receiving payments or research grants from Pfizer, and those
programs have approved Pfizer-funded clinical trials. Given how many research protections programs
AAHRPP has accredited, the number of possible conflicts-of-interest is alarming.

According to your website, “AAHRPP’s Board of Directors is responsible for overseeing the
accreditation process.” AAHRPP has potentially created significant conflicts-of-interest by appointing
former Pfizer executives to its Board. These undisclosed conflicts undermine AAHRPP’s claim that it
accredits research protections programs in an “independent,” “unbiased,” and “transparent” manner.


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AAHRPP’s website lists Dr. Ponni Subbiah as the Founder of Global Med Strategies, LLC. It appears
that this business is one month old and has one staff member—Dr. Subbiah. Public records reveal that
Dr. Subbiah was for sixteen years a senior corporate executive at Pfizer. Dr. Subbiah was Medical
Director and Team Leader of Global Medical Affairs for the Aricept Team, Director of Medical Affairs
for Latin America, Pfizer Global Health Fellow, Senior Medical Director of US Medical Affairs for
Neurology and Diversified Products, Vice President for US Medical Affairs, Vice President for Global
Medical Affairs: Urology/Respiratory Group, and Vice President for Global Access in the Emerging
Markets Business Unit. Dr. Subbiah was one of Pfizer’s key corporate spokespersons for Chantix and
other controversial drugs. Does Dr. Subbiah still have equity in Pfizer now that she is a member of
AAHRPP’s Board of Directors?

AAHRPP’s website states that Board Member Marc Wilenzick is a Principal at Stonington Heights
Advisors. Your website does not disclose that Mr. Wilenzick was for over fifteen years Assistant
General Counsel and then Deputy Compliance Officer & Assistant General Counsel for Pfizer. Does
Mr. Wilenzick still have equity in Pfizer now that he is a member of AAHRPP’s Board of Directors?

AAHRPP’s website notes that Dr. Cathryn Clary, a member of AAHRPP’s Board of Directors, is Head,
US Medical and Chief Scientific Officer for Novartis. However, AAHRPP’s website does not disclose
that Dr. Clary was previously Senior Vice President of US Medical and Regulatory Affairs at Ipsen
Pharmaceuticals. AAHRPP also fails to disclose that Dr. Clary spent thirteen years at Pfizer. During her
time at Pfizer Dr. Clary was a Medical Director in CNS, Vice President of U.S. Medical, Senior Vice
President of US Medical, and Vice President of US External Medical Affairs. A financial disclosure
statement accompanying one of Dr. Clary’s publications describes her as a “major stock shareholder” in
Pfizer. Does Dr. Clary still hold stock in Pfizer? Does she also hold stock in Novartis, Ipsen
Pharmaceuticals, and other pharmaceutical companies?

I request that you disclose whether Dr. Subbiah, Mr. Wilenzick, and Dr. Clary retained equity in Pfizer
while serving on AAHRPP’s Board of Directors. I also ask that you disclose whether other AAHRPP
Directors, staff members, members of the Accreditation Council, or site visitors were employed at
Pfizer, possessed equity in Pfizer, or had other financial ties to Pfizer when AAHRPP accredited Pfizer
in 2009 and 2013. In addition, I request that AAHRPP disclose whether any past or present directors,
staff members, Accreditation Council members, or site visitors have financial conflicts-of-interest
related to other organizations accredited by AAHRPP. Based on my discovery that three former Pfizer
executives are Directors of AAHRPP, I request that AAHRPP disclose all financial conflicts-of-interest
related to all of the organizations it has accredited or reaccredited from the time AAHRPP was
established to the present. Please send me AAHRPP’s conflict-of-interest policy in addition to copies of
all disclosures of interests made by past and present AAHRPP directors, members of the Council on
Accreditation, staff members, and site visitors.

Corporations such as Pfizer and Novartis sponsor clinical studies reviewed by research protection
programs that are accredited by AAHRPP. Such corporations also provide speakers’ fees, grants and
other sources of funding to academic institutions, financial support for continuing medical education,
and other payments to organizations with research protection programs accredited by AAHRPP. It is
therefore possible that individuals conducting site accreditation visits, serving on the Board of Directors
or Council on Accreditation, or connected in other ways to AAHRPP have financial conflicts related to
companies funding clinical studies reviewed by research protection programs AAHRPP accredits. I am
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unable to find any public record of AAHRPP disclosing financial conflicts-of-interest related to its
accreditation of research protection programs that have reviewed and approved clinical studies
sponsored by Pfizer and other corporations. In the service of promoting transparency and determining
whether trust in your organization’s accreditation process is warranted, I request that AAHRPP disclose
all such conflicts-of-interest.

I also request that AAHRPP disclose all payments it has received for accreditation, “reviews” of the
organizations it also accredits, and other services as well as the sources of all such payments. If you are
unwilling to disclose possible financial conflicts-of-interest then I urge AAHRPP to stop describing
itself as an independent, unbiased, transparent, and accountable accreditation body.

Finally, I request that you provide credible evidence supporting your claim that AAHRPP’s
accreditation process “helps reduce the risk to research participants.” In 1996, eleven Nigerian children
died during a controversial clinical trial testing Trovan, Pfizer’s experimental drug for meningitis. Five
of the children died after taking Trovan. Pfizer ultimately paid $75 million in a settlement with
Nigeria’s Kano state. Given your statement that AAHRPP does not investigate allegations of research
misconduct, did AAHRPP conduct thorough inquiry into the Trovan study before it accredited Pfizer’s
research protections program in 2009? Shortly after receiving AAHRPP accreditation, Pfizer paid $2.3
billion to settle civil and criminal allegations that it had fraudulently marketed Bextra, Geodon, Zyvox,
and Lyrica. Despite Pfizer’s settlement with the U.S. Department of Justice, AAHRPP reaccredited
Pfizer in 2013. “Off-label” marketing of drugs by Pfizer and other pharmaceutical companies has a
relationship to “seeding” trials sponsored by these companies and conducted at organizations accredited
by AAHRPP. I request that you explain why AAHRPP’s accreditation processes do not appear to be
able to detect clinical trial-related corporate activity that has subsequently resulted in substantial legal
settlements. Such failures of oversight lead me to ask that you address whether the accreditation service
AAHRPP advertises is capable of identifying and addressing serious cases of research misconduct.

In summary, I request:

1) AAHRPP’s conflict-of-interest policy;

2) Full disclosure of possible financial conflicts-of-interest involving all past and present
individuals associated with AAHRPP. The documents I am requesting includes disclosure of
conflict–of-interest statements prepared by former and current members of AAHRPP’s Board of
Directors, past and present staff members, past and present members of the Accreditation
Council, and past and present site visitors;

3) Disclosure of all financial ties (including but not restricted to equity and prior employment)
connecting former and current members of AAHRPP’s Board of Directors, past and present
staff members, past and present members of the Accreditation Council, and past and present site
visitors to organizations accredited by AAHRPP;

4) Disclosure of all documentation related to financial conflicts-of-interest involving research
protection programs approving clinical studies sponsored by corporations with financial ties to
individuals at AAHRPP;

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5) A complete record of all payments AAHRPP has received for its services and the sources of
those payments;

6) Evidence supporting AAHRPP’s claims that accreditation reduces risks to research subjects;

7) An explanation of why AAHRPP’s accreditation process is apparently unable to detect and halt
corporate activity that has lead to substantial legal settlements with the U.S. Department of
Justice.

As my request for full disclosure of conflicts-of-interests indicates, I am concerned about AAHRPP’s
conflicted review of research protections at the University of Minnesota as well as possible additional
conflicts-of-interest connecting AAHRPP to the research protections programs it accredits and the
sponsors of clinical studies reviewed by those research protection programs. Full disclosure will help
address the question of whether financial conflicts-of interests are compromising the integrity of
AAHRPP’s accreditation service.

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