Jay D. Amsterdam: The Paroxetine 352 Bipolar Study Ethical Conduct

 

4. Attachments  E and F (Letter to the Office of Research Integrity – Lawyer’s letter excerpt)

 

       Dr. Amsterdam only recently became aware that two of the lead authors of Study 352, including his direct supervisor, were linked to ghostwriting through a letter from the Project On Government Oversight (POGO) to NIH Director Francis Collins in November 2010, posted on POGO's website at www.pogo.org/pogofileslletters/public-health/ph-iis-20101129.html. Like the examples contained in POGO's letter to NIH, Dr. Amsterdam believes the manuscript published in the American Journal of Psychiatry was ghostwritten by STI, which was hired by GSK and paid with GSK funds, and that the individuals above lent their names as "authors" to the manuscript. 

       Based upon evidence presented in this complaint and the documents attached hereto, it appears that most, if not all, of the" guest authors" were determined by GSK in conjunction with the "medical communications" firm, STI. STI has had a longstanding history of ghostwriting scientific and medical articles and textbooks which have been attributed to prominently known academics - a practice that has been the subject of mounting criticism. See, for example, an editorial in the Journal of the American Medical Association regarding ghostwriting in relation to Merck's promotion and sales of VIOXX. (Attachment E.) 

       The acknowledgement section of the published manuscript states that Study 352 was conducted and published with support from NIMH grant MH-51761. (Attachment A.) According to a recent search of the NIH Reporter database, NIMH grant MH-51761 was part of an "infrastructure support" and "core-patient recruitment and assessment" project for NIH-funded clinical research trials. (Attachment F.) In this case, it was used to support the recruitment and assessment of research subjects for participation in this GSK-sponsored and GSK-funded clinical trial of Paxil for the treatment of patients with bipolar type I major depression.

  

Attachment  E

Catherine D. DeAngelis and Phil B. Fontanarosa: Impugning the integrity of medical science. The adverse effect of industry interest. Editorial. JAMA 2008;299:1833-5.

Attachment F

NIH RePORTER - NIH Portfolio Online Search Results. Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, Oakes R, Pitts CD. Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. Am J Psychiatry 2001;158(6):906-12.

U.S. Department of Health and Human Services

Home > RePORTER > Search Results

Search Results - NIH RePORTER-NIH Research Portfolio Online ...

There were 22 results matching your search criteria.

 

Project Number

Sub #

Project Title

Principal Investigator

Organization

FY

Admin IC

5R24MH051761-05

9002

CORE-NEUROENDOCRINOLOGY,

NEUROCHEMISTRY, AND BRAIN IMAGING

BONSALL, ROBERT W.

EMORY UNIVERSITY

1998

NIMH

5R24MHQ51761-04

9002

CORE-NEUROENDOCRINOLOGY,

NEUROCHEMISTRY, AND BRAIN IMAGING

BONSALL, ROBERT W.

EMORY UNIVERSITY

1997

NIMH

5R24MH0517B1-03

9002

CORE-NEUROENDOCRINOLOGY,

NEUROCHEMISTRY, AND BRAIN IMAGING

BONSALL, ROBERT W

 

1996

NIMH

5R24MH051761-05

9001

CORE-PATIENT RECRUITMENT AND ASSESSMENT

GOODMAN, SHERRYL

EMORY UNIVERSITY

1998          

NIMH

5R24MH351761-04

9001

CORE-PATIENT RECRUITMENT AND ASSESSMENT

GOODMAN, SHERRYL

EMORY UNIVERSITY

1997          

NIMH

5R24MH051761-03

9001

CORE-PATIENT RECRUITMENT AND ASSESSMENT

GOODMAN, SHERRYL

 

1996          

NIMH

5R24MH051761-05

9004

CORE-EXPERIMENTAL DESIGN AND BIOSTATISTICS

MARSTELLER, FREDERICK A

EMORY UNIVERSITY

1998          

NIMH

5R24MH051761-04

9004

CORE-EXPERIMENTAL DESIGN AND BIOSTATISTICS

MARSTELLER, FREDERICK A

EMORY UNIVERSITY

1997          

NIMH

5R24MH051761-03

9004

CORE-EXPERIMENTAL DESIGN AND BIOSTATISTICS

MARSTELLER, FREDERICK A

 

1996          

NIMH

5R24MH051761-05

9003

CORE-BIOLOGICAL TISSUES AND FLUIDS

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1998

NIMH

5R24MH051761-05

 

INFRASTRUCTURE SUPPORT PROGRAM

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1998

NIMH

5R24MH051761-04

9003

CORE-BIOLOGICAL TISSUES AND FLUIDS

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1997

NIMH

5R24MH051761-04

 

INFRASTRUCTURE SUPPORT PROGRAM

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1997

NIMH

3R24MH051761-04S1

 

INFRASTRUCTURE SUPPORT PROGRAM

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1997

NIMH

5R24MH051761-03

9003

CORE-BIOLOGICAL TISSUES AND FLUIDS

NEMEROFF, CHARLES B

 

1996

NIMH

5R24MH051761-03

 

INFRASTRUCTURE SUPPORT PROGRAM

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1996

NIMH

5R24MH051761-02

 

INFRASTRUCTURE SUPPORT PROGRAM

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1995

NIMH

1R24MH051761-Q1A1

 

INFRASTRUCTURE SUPPORT PROGRAM

NEMEROFF, CHARLES B

EMORY UNIVERSITY

1994

NIMH

5R24MH051761-04S1

9001

CORE-PATIENT RECRUITMENT AND ASSESSMENT

Unavailable

EMORY UNIVERSITY

1997

NIMH

5R24MH051761-04S1

9002

CORE-NEUROENDOCRINOLOGY,

NEUROCHEMISTRY, AND BRAIN IMAGING

Unavailable

EMORY UNIVERSITY

1997

NIMH

5R24MH051761-04S1

9003

CORE-BIOLOGICAL TISSUES AND FLUIDS

Unavailable

EMORY UNIVERSITY

1997

NIMH

5R24MH051761-04S1

9004

CORE-EXPERIMENTAL DESIGN AND BIOSTATISTICS

Unavailable

EMORY UNIVERSITY

1997

NIMH

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