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Project on Government Oversight

POGO's first reply to letters from Dr. Schatzberg and Dr. Nemeroff

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December 8, 2010 | By: Scott H. Amey, J.D.

Mr. Stuart C. Clark
Carr Ferrell
120 Constitution Drive
Menlo Park, CA 94025

Lawrence J. Myers
Smith Moore LLP
Atlantic Center Plaza
1180 West Peachtree Street, NW
Suite 2300
Atlanta, GA  30309-3482

Dear Mr. Clark and Mr. Myers:

In response to your letters (Attachment A) and after a comprehensive internal review, the Project On Government Oversight (“POGO”) will make minor changes to the online version of its November 29, 2010, letter to National Institutes of Health (“NIH”), which expressed concerns about the integrity of federally funded research.

Your letters describe alleged “false statements” by POGO as related to the physician handbook titled Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, which listed as authors Alan F. Schatzberg, MD, of Stanford Medical Center and Charles B. Nemeroff, MD, formerly with Emory University School of Medicine and now at University of Miami School of Medicine.

First, when the handbook was published, Dr. Nemeroff and Dr. Schatzberg thanked Scientific Therapeutics Information, Inc. (“STI”) for “editorial assistance” and GSK for “providing an unrestricted educational grant.” In your letter, you describe the initial materials provided by STI as “boilerplate.” That statement, as you can see from the discussion below, appears to be far from the truth. Therefore, we will only make minor changes to POGO’s letter to NIH, which is posted on POGO’s website. (Attachment B)  

According to the 2007 deposition taken in cases involving Paxil against SmithKline Beecham Corporation, now operating as GlaxoSmithKline (“GSK”), Ms. Sally Laden calls herself a “freelance writer” specializing in “science and medical writing.” Her testimony further stated that she takes data, condenses it into a manuscript, and works “with the authors to make sure they are happy with the data as presented.” She further agreed that her role was to help in the preparation of the initial draft, edit the subsequent draft, and address reviewers’ comments.

In a letter dated February 4, 1997, and addressed to Dr. Nemeroff, Ms. Laden provided an updated status of the handbook. Ms. Laden’s letter stated that “We have begun development of the text,” and she established a timeline for which Dr. Nemeroff and Dr. Schatzberg would receive draft copies of that text. That letter introduced Ms. Coniglio as the “primary technical writer and project manager” and Ms. Laden as the “technical editor.” (Emphasis added) POGO understands that the letter was also circulated to GlaxoSmithKline employees.

After a review of the February 25, 1997, “PRELIMINARY DRAFT” (emphasis and capitalization in original) and of the 1999 published version of the handbook, POGO feels strongly that its statements regarding STI’s involvement in the drafting of the handbook are accurate and supported by the evidence. Complete sentences and paragraphs that were in the 1997 “preliminary draft” created by STI appear in the handbook. For example, the draft “developed by” Ms. Coniglio and Ms. Laden reads:

Alzheimer’s Disease (AD) is the most common primary, progressive degenerative dementia in the elderly and the fourth leading cause of death in the United States (Keefover, 1996; Raskind, 1993). At an annual cost of more than $67 billion in the US alone, AD has important public health implications, especially in concert with the unparalleled growth of the aged population (Keefover, 1996).

This nearly mirrors the text that appears in the published book, which reads:

Dementia of the Alzheimer’s type, or Alzheimer’s disease (AD), is the most common primary, progressive, degenerative dementia in the elderly and the fourth leading cause of death in the US. At an annual cost of more than $90 billion in the US alone, AD has important public health implications, especially in concert with the unparalleled growth of the aged population. [Footnotes omitted]

Additional language and tables on Alzheimer’s Disease follow nearly word for word the 1997 “preliminary draft,” as do passages involving Tacrine, Cholinergic Agonists, and Selegiline, and the glossary. As POGO stated in its NIH letter, that first edition was “Developed by” Diane M. Coniglio, PharmD and Sally K. Laden, MS of STI.

According to a statement from the American Psychiatric Association the book “was written by the two authors….They did receive editorial assistance, but they were the authors.” In a statement to the Miami Herald, Dr. Nemeroff was quoted saying, “Such editorial assistants can provide help with such tasks as tracking down references and the like, but certainly do not have the clinical expertise or experience to put such a volume together.” These statements are undermined by Ms. Laden’s February 4, 1997, letter to Dr. Nemeroff that outlines technical and editorial assistance that was to be provided by STI as well as the detailed content of STI’s “preliminary draft” which was published in the book. Per written guidance about “Byline Authors” from the International Committee of Medical Journal Editors (“ICMJE”), Ms. Coniglio and/or Ms. Laden should have been listed as “authors” if their support included conception and design, gathering data, drafting or revising intellectual content, and approving the version to be published.

Second, according to your letters, the allegation “that GSK was given all three drafts, and was sent page proofs for final approval” is false. We would like to point out that this process is laid out in the timeline provided to Dr. Nemeroff by Ms. Laden of STI. We would also like to point out that this timeline and STI’s “preliminary draft” were provided by GSK during litigation in another case and therefore were in GSK’s possession. We also note that with regards to GSK’s involvement in the handbook, Dr. Nemeroff’s told the Miami Herald:

I would guess that [GSK] would have had to review the content to comply with [Food and Drug Administration] regulations on a pharmaceutical company distributing a publication, but this is hardly my area of expertise.

The evidence available at this time indicates that GSK apparently was involved in the handbook drafting process. Because POGO is currently unable to document the nature and extent of GSK’s actual involvement, POGO will alter the NIH letter as indicated in Attachment B

Finally, your allegations concerning Mr. Thacker’s previous employment with the Senate are extremely vague and not related to POGO or our work.  Please contact the Senate directly if you have concerns about the actions of a Senator or his staff.

Sincerely,

Scott H. Amey
General Counsel
 
 
Enclosures:       2 
 
cc:        Francis S. Collins, MD, Ph.D., Director
            National Institutes of Health

 

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