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Psychiatry Texbook Penned by Two Academic Leaders --GSK Ghosted Print E-mail
Tuesday, 30 November 2010
“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

A letter of complaint, by the Project on Government Oversight (POGO) was sent to the director of the National Institutes of Health (below), documenting $66.8 million in NIH grants that were awarded to a handful of psychiatrists who penned their name to ghostwritten scientific publications.

The instances identified in the letter involve ghostwriting by only one company--Scientific Therapeutics Information--and only one drug--GlaxoSmithKline's antidepressant, Paxil (peroxetine).

Duff Wilson of The New York Times reports (below) that previously sealed GlaxoSmithKline documents  show that a psychiatry textbook, whose listed authors are psychiatrists,  Charles Nemeroff, MD and Alan Schatzberg, MD, was actually ghostwritten by Sally Laden of STI. GSK paid the ghostwriter and the "authors" who penned their names to the book.

 The sheer audacity prompted former FDA commissioner, Dr. David Kessler to exclaim: "To ghostwrite an entire textbook is a new level of chutzpah. “I’ve never heard of that  before. It takes your breath away.”  Surely that is a dubious distinction in academic medicine! 

But then, psychiatry and its leadership has the notorious distinction of lacking a minimal scientific foundation to support just about any of its clinical practice guidelines--as the entire field is driven not by honest research, but by the financial interests of the pharmaceutical industry and their paid "partners" in academia.

Drs. Nemeroff and Schatzberg are two of psychiatry's influential academics who have received tens of million dollars in taxpayer grants, who have chaired departments of psychiatry at Emory University, the University of Miami (CN) and Stanford University (AS). 

The POGO letter of complaint is accompanied by a "smoking gun"--a 1997 letter written by the book ghostwriter:

"A draft of the textbook states that it was sponsored by GSK and written by Diane M. Coniglio and Sally K. Laden of STI. (Attachment D )  In a letter addressed to Dr. Nemeroff, Ms. Laden provided an updated status of the textbook. Her timeline states that she wrote the first draft, which was then sent to Drs. Nemeroff and Schatzberg, the publisher, and GlaxoSmithKline. The timeline also notes that GSK was given all three drafts, and was sent page proofs for final approval. (Attachment E)"  

Drs. Nemeroff and Schatzberg insist that the the company's grant was "unrestricted" and, therefore, they claim to have done "most of the work."

Duff Wilson reports that Dr. Nemeroff defends the book, stating it "was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness."

Ghostwritten articles and ghostwritten texbooks paid for and controlled by self-serving drug companies have undermined the integrity of science and pose a threat to public health!!

Pity the people whose doctors' clinical practice is guided  by fraud.

Below, we post a copy of the POGO letter to the director of NIH--in which a handful of researchers who used ghostwriters for scientific publications are identified. These prominent academic psychiatrists received $66.8 million in NIH grants over the last five years.   

Shouldn't anyone who engages in professional misconduct such as fraud, which corrupts the integrity and practice of medicine, be disqualified from having academic standing?

 

Posted by Vera Hassner Sharav

~~~~~~~~~~~~~~~~~~~~

THE NEW YORK TIMES

November 29, 2010

Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say

Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.”

The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.

“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

The book has never been in wide circulation and has not been sold for a few years. Guidelines restricting the use of industry money to support medical journal articles or doctors’ research have come into wide acceptance within the last several years, to try to minimize the influence of companies’ marketing on medical practices.

The book’s listed co-authors were Dr. Charles B. Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009 and Emory University before that, and Dr. Alan F. Schatzberg, who was chairman of psychiatry at the Stanford University School of Medicine from 1991 until last year.

The letter documenting the relationship between Dr. Nemeroff, a writing company and SmithKline was dated Feb. 4, 1997. It and a “preliminary draft” of the book, dated Feb. 21, 1997, and adding Dr. Schatzberg’s name were released Monday by the Project on Government Oversight, a Washington advocacy group. They were attached to a letter of complaint to Dr. Francis S. Collins, director of the National Institutes of Health. In the letter, Danielle Brian, executive director of the project, and Paul Thacker, an investigator, formerly with the staff of Senator Charles Grassley of Iowa, also cited other examples of what they termed ghostwriting and asked the N.I.H. for better policing of such practices.

The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.

Responding to questions by e-mail last week, Dr. Nemeroff and Dr. Schatzberg emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work. SmithKline “had no involvement in content,” Dr. Schatzberg said, adding, “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.”

Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”

But the writing company, Scientific Therapeutics Information of Springfield, N.J., had developed “a complete content outline” for Dr. Nemeroff’s comment, according to the 1997 letter from one of the company’s officials. The company also said it had “begun development of the text.” The writing company did not respond to requests for comment.

Kevin G. Colgan, a spokesman for GlaxoSmithKline, said the company’s role in the book was described in its preface. In recent years, he added, the company has tightened its internal guidelines for medical writers.

Ron McMillen, chief executive of American Psychiatric Publishing, which published the book, said he reviewed files on it Monday and found no evidence of influence by the writing company or GlaxoSmithKline. But Mr. McMillen also said he had been unaware of the plan outlined in the two-page letter to Dr. Nemeroff.

“This would show more involvement than we would accept,” he said after reviewing it.

The book sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon, Mr. McMillen said. The authors together received a 15 percent royalty of the $120,000 sales, or about $18,000, he said.

Since there are about 100,000 family physicians in the United States, the book reached only a small percentage of them and has probably declined in usage since 1999. Dr. Howard A. Brody, an author, blogger and professor of family medicine at the University of Texas Medical Branch at Galveston, speculated that family doctors may have had some resistance to a book from a psychiatric press.

Mr. McMillen said the book was co-published with the American Medical Association. He said it was distributed until a few years ago.

Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. “Remarkably, the book remains quite accurate and relevant to clinical practice today,” he said.

Dr. Nemeroff said he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.

Dr. Schatzberg said he had not seen the 1997 letter to Dr. Nemeroff. He termed it “a theoretical proposal that bears little, if any relationship to what actually happened.”

Dr. Lo, who is a professor of medicine and director of the medical ethics program at the University of California, San Francisco, said that medical textbooks and handbooks should make it clear — as peer-reviewed journals now do — whose idea it was, who wrote the first draft, and who edited. Dr. Lo and other experts said ghostwriting has receded in recent years with tougher journal standards.

Dr. Nemeroff and Dr. Schatzberg have been listed on other titles, including co-editors of the Textbook of Psychopharmacology, a book for psychiatrists and medical students, whose third edition appeared in 2003. In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving N.I.H. grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline.

  ~~~~~~~~~~~~~~~~~~~~~~~~

 

POGO Letter to NIH on Ghostwriting Academics

November 29, 2010

Francis S. Collins, M.D., Ph.D.
Director
National Institutes of Health
One Center Drive
Bethesda, Maryland 20892
 
Via email: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
 
Dear Dr. Collins:
 
The Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO’s investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government. We take a keen interest in strengthening the integrity of federally funded science, and have particular concerns involving the National Institutes of Health (NIH), which receives around
$30 billion a year in federal taxpayer dollars to fund biomedical research.[1]

We are writing to urge that NIH curb the practice of ghostwriting in academia. As the Director of the world’s largest and most prestigious funding source for biomedical research, you must set policies that require NIH-funded academic centers to ban ghostwriting to strengthen scientific integrity.

You obviously recognize how corrosive ghostwriting is to science. In an interview last year on C-SPAN, you said:

I was shocked by that revelation—that people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented….If we want to have the integrity of science preserved, that’s not the way to do it.[2]

We couldn’t agree more, and would think NIH policies would prevent such practices. However, based on documents in our possession, we have discovered that the NIH gave $66.8 million in grants over the last five years to a handful of researchers who used ghostwriters for scientific publications. These documents were made public during litigation[3] about Paxil (paroxetine), an anti-depressant sold by GlaxoSmithKline (GSK). Although these documents discuss actions that happened in the past, this behavior doesn’t usually come to light until years after it occurred when the evidence is discovered during litigation, and therefore the practice is likely continuing today. 

According to the documents, GSK began to push sales of Paxil in the early 1990s with an extensive ghostwriting program run by the marketing firm Scientific Therapeutics Information (STI). For instance, STI wrote a proposal to organize GlaxoSmithKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton Hotel in Palm Beach, Florida. STI chose Dr. Charles Nemeroff of Emory University as their speaker to lay out the meeting’s agenda and objectives. Dr. Nemeroff apparently led discussions on how to “evaluate clinical research/promotional programs” and “generate information for use in promotion/education.” (Attachment A)

STI’s ghostwriting included editorials, journal articles, and even a textbook that was widely used by primary care physicians to treat psychiatric disorders. Below are further details of these incidents and the NIH funding of these researchers.

Drs. Dwight Evans and Dennis Charney
NIH funding since FY 2006: $30.6 million
NIH funding FY 2010: $10,929,790

According to the documents, Sally Laden of STI wrote an editorial for Biological Psychiatry in 2003 for Drs. Dwight Evans, Chairman of the Department of Psychiatry at the University of Pennsylvania School of Medicine, and Dennis Charney, then an employee at the NIH and now Dean of Research at the Mt. Sinai School of Medicine at New York University.[4]

In an email to a GSK employee, Ms. Laden wrote, “Is there a problem with my invoice for writing Dwight Evans’ editorial for the [Depression and Bipolar Support Alliance]’s comorbidity issue to Biological Psychiatry?” (Attachment B) Yet, when published, the “authors” Evans and Charney only stated, “We acknowledge Sally K. Laden for editorial support.” (Attachment C)

According to the NIH Reporter database of grants, Dr. Evans is the primary investigator on two NIH grants. The funding for these grants in 2010 is $940,450. Dr. Charney is the primary investigator on one NIH grant, whose funding in 2010 is $9,989,340. Over the last five years, the NIH has given both researchers $30.6 million in grants.[5]

Drs. Alan Schatzberg and Charles Nemeroff
NIH funding since FY 2006: $23.3 million
NIH funding FY 2010: $2,374,242

STI also ghostwrote a physician textbook, Recognition and Treatment of Psychiatric Disorders, for Drs. Alan Schatzberg of Stanford Medical Center and Charles Nemeroff, formerly with Emory University School of Medicine and now at University of Miami School of Medicine.

A draft of the textbook states that it was sponsored by GSK and written by Diane M. Coniglio and Sally K. Laden of STI. (Attachment D)  In a letter addressed to Dr. Nemeroff, Ms. Laden provided an updated status of the textbook. Her timeline states that she wrote the first draft, which was then sent to Drs. Nemeroff and Schatzberg, the publisher, and GlaxoSmithKline. The timeline also notes that GSK was given all three drafts, and was sent page proofs for final approval. (Attachment E

However, in the textbook’s published preface, Dr. Nemeroff and Schatzberg only thank STI for “editorial assistance” and GSK for “providing an unrestricted educational grant.” (Attachment F)

The fact that STI wrote the first draft undermines Drs. Nemeroff and Schatzberg’s assertion that STI provided mere “editorial assistance.” Also, GSK’s involvement in every draft, to include sign-off of page proofs, undermines the assertion that the company’s grant was “unrestricted.”

According to the NIH Reporter database of grants, Dr. Schatzberg is the primary investigator on four NIH grants. The funding for these grants in 2010 is $2,374,242. Over the last five years, the NIH has given both researchers $23.3 million in grants.[6]

Dr. Kimberly Yonkers
NIH funding since FY 2006: $6.4 million
NIH funding FY 2010: $1,241,257

In 2002, a GSK employee emailed Dr. Yonkers of Yale School of Medicine, writing, “Attached please find the poster to be presented at the US Psych Congress. Please provide feedback.” (Attachment G)

Other documents make it clear that Dr. Yonkers was provided at least one ghostwritten study. For instance, the cover page for a study on Paxil to be published in Psychopharmacology Bulletin notes that “Draft I” was prepared by Sally Laden and another STI employee. The top line of the draft even reminds Dr. Yonkers to remove evidence of STI’s involvement, stating, “STI Cover Page—To be removed before submission.” (Attachment H)

When the study was later published, it notes that it was funded by an “unrestricted educational grant” from GSK, but makes no mention of STI’s involvement in the paper. (Attachment I)

According to the NIH Reporter database of grants, Dr. Yonkers is the primary investigator on three NIH grants. The funding for these grants in 2010 is $1,241,257. Over the last five years, the NIH has given Dr. Yonkers $6.4 million in grants.[7]

Dr. Martin Keller
NIH funding since FY 2006: $7.0 million
NIH funding FY 2010: $1,341,493

Finally, we would like to turn your attention to Dr. Martin Keller of Brown University Medical School. In July 2001, Dr. Keller and several colleagues published a widely read study, called Study 329, on the efficacy of Paxil (paroxetine) to treat adolescent major depression.[8] Study 329 concluded, “The findings of this study provide evidence of the efficacy and safety of the SSRI, paroxetine, in the treatment of adolescent major depression.”[9]

Study 329, however, was clearly flawed—a mere two years later, the United Kingdom government warned British physicians to not prescribe Paxil for children due to fears of potential suicide.[10] In May 2004, our own FDA issued a similar warning.[11]

In early 2007, the BBC’s investigative program Panorama released a documentary on Paxil and Study 329.[12] The documentary publicized hundreds of secret emails from GSK, which were uncovered during litigation, that showed GSK knew years before the publication of Study 329 that Paxil did not provide efficacy in treating adolescents for depression.

With regards to Study 329 specifically, the BBC reported online about emails written by a company hired by GSK to provide PR for Study 329.[13] One email read, “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.”[14] Another email read, “Essentially the study did not really show [Paxil] was effective in treating adolescent depression, which is not something we want to publicize.”[15] (Attachment J)

The documentary also noted that Dr. Keller published Study 329 with the help of ghostwriter Sally Laden. In an email to Ms. Laden about Study 329, Dr. Keller wrote, “You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me...”[16] But before the final draft was released to Dr. Keller, Ms. Laden sent it to GSK for final approval so that the manuscript “can be released to Martin Keller, MD to submit for publication….” (Attachment K)

In June 2008, former Boston Globe reporter Alison Bass published Side Effects, a book that documents multiple problems with Dr. Keller’s research used in Study 329. Passages of the book discuss internal documents from Brown University regarding Dr. Keller’s research on Paxil. The documents were provided to Ms. Bass by Donna Howard, the former assistant administrator in Brown’s department of psychiatry. Ms. Howard said that data in Study 329 was changed to satisfy the study’s sponsor, GSK. According to Howard, “Everybody knew we had to keep [GlaxoSmithKline] happy and give them the results they wanted.”[17]

Even Brown University’s student newspaper, The Brown Daily Herald, published an exposé on Dr. Keller’s research and Study 329.[18] Dr. Keller refused to respond to questions from the paper. An editorial that accompanied this story stated, “We do believe that [Dr. Keller’s] actions directly affect the integrity of the University.”[19] Yet, despite the multiple public revelations, Brown University has done nothing.

POGO searched the NIH Reporter database of grants and was surprised to find that, despite all the repetitive controversy, Dr. Keller is still receiving NIH grants.  Currently, he is the primary investigator on two NIH grants, with funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr. Keller $7 million in grants.[20]

Conclusion

The instances in this letter involve ghostwriting by only one company and involve only one drug. Yet the evidence is that this practice is widespread and pervasive in academia. A study published in PLoS Medicine in February of this year found that only ten of the top fifty medical schools explicitly prohibit ghostwriting.[21] The study’s authors concluded that “medical ghostwriting is a threat to public health….”[22]

NIH must take a firm stance against ghostwriting, both to protect public health and the integrity of NIH funding. We ask that you implement new policies that will require institutions to ban ghostwriting, and to make NIH funding contingent upon periodic certification from institutions that ghostwriting is strictly prohibited and that enforcement mechanisms such as disciplinary action and dismissal are in place. Setting this example will improve the integrity of federally funded science. Additionally we ask that you fund seminars and research on ghostwriting to educate physicians about this practice and ensure that it disappears from biomedical research altogether.

We appreciate your review of this letter and your time, and look forward to working with you on the issue of ghostwriting in academia. If you have any questions, please do not hesitate to contact Paul Thacker at (202) 347-1122 or This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Sincerely,
 
 
Danielle Brian
Executive Director

Paul Thacker
Investigator                     

Attachments A-K                                         

______________________

[1] The White House, Office of Management and Budget, “Department of Health and Human Services,” Budget of the United States Government, Fiscal Year 2011.  (Downloaded November 19, 2010)
[2] “Newsmakers with Dr. Francis Collins,” C-SPAN, December 21, 2009.  (Downloaded November 19, 2010)
[3] Cunningham v. SmithKline Beecham Corp., U.S. District Court, Northern District of Indiana, Case No. 2:07-CV-174 (2006). http://www.contractormisconduct.org/ass/contractors/138/cases/1249/1772/glaxosmithkline-cunningham_complaint.pdf ; Smith v. SmithKline Beecham Corp., Superior Court of California, Orange County, Case No. 04CC00590 (2004); Bratt v. SmithKline Beecham Corp., United States District Court, Eastern District of California, Case No. 2:06-cv-1063 (2006); Forst v. SmithKline Beecham Corp., United States District Court, Eastern District of Wisconsin, Case No. 07-CV-612 (2007); Steinberg v. SmithKline Beecham Corp., Superior Court of California, County of Santa Clara, Case No. 1-04-CV-029096 (2004).
[4] Mount Sinai School of Medicine, “Dennis S. Charney.”  (Downloaded November 22, 2010)
[5] Department of Health and Human Services, National Institutes of Health, “NIH Research Portfolio Online Reporting Tools Expenditures and Results.”  (Downloaded November 22, 2010) (hereinafter “NIH RePORTER”)
[6] NIH RePORTER.
[7] NIH RePORTER.
[8] M.B. Keller et al., “Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial,” Journal of the Academy of Child & Adolescent Psychiatry, Vol. 40, Issue 7, July 2001, pp. 762-772.  (Downloaded November 19, 2010) (hereinafter Study 329)
[9] Study 329, pp. 762-772.
[10] Vicki Brower, “Analyse this: Many psychiatrists claim that children are undertreated for depression and ADHD, but critics argue abuse,” EMBO Reports, Vol. 4, Issue 11, 2003, pp. 1022-1024.  (Downloaded November 19, 2010)
[11] Food and Drug Administration, “Dear Healthcare Professional,” May 2004.  (Downloaded November 19, 2010)
[12] “Secrets of the Drug Trials: Transcript,” BBC One: Panorama, January 29, 2007.  (Downloaded November 19, 2010) (hereinafter “Secrets of the Drug Trials: Transcript”)
[13] “Secrets of the Drug Trials,” BBC One: Panorama, January 29, 2007.  (Downloaded November 19, 2010) (hereinafter “Secrets of the Drug Trials”)
[14] “Secrets of the Drug Trials.”
[15] “Secrets of the Drug Trials.”
[16] “Secrets of the Drug Trials: Transcript.”
[17] Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, Chapel Hill, North Carolina: Algonquin Books of Chapel Hill, 2008.
[18] Chaz Firestone and Chaz Kelsh, “Keller’s findings on Paxil disputed by doctors, FDA: Controversial study may have hid suicide links,” The Brown Daily Herald, September 24, 2008.  (Downloaded November 19, 2010)
[19] “Accountable Academics,” The Brown Daily Herald, September 24, 2008.  (Downloaded November 19, 2010)
[20] NIH RePORTER.
[21] Jeffrey R. Lacasse and Jonathan Leo, “Ghostwriting at Elite Academic Medical Centers in the United States,” PLoS Medicine, Vol. 7, Issue 2, February 2010.  (Downloaded November 19, 2010) (hereinafter “Ghostwriting at Elite Academic Medical Centers in the United States”)
[22] “Ghostwriting at Elite Academic Medical Centers in the United States.”


 

 
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