POGO reminds the director of the National Institutes of Health (posted below) that taxpayers provide the NIH with $30 billion annually to fund biomedical research. But the proliferation of ghostwritten reports by federally funded researchers are undermining the integrity of NIH, the scientific literature, and result in medical practices that cause patients harm.
Corporate documents, uncovered during the course of litigation, revealed that GlaxoSmithKline contracted a marketing agency–Scientific Therapeutics Information– to ghostwrite a series of reports and editorials, even entire portions (if not an entire) handbook in psychiatry –which were then penned by prominent academic psychiatrists–for publication in scientific journals, promoting various uses for the antidepressant, Paxil (paroxetine).
POGO discovered that six researchers–including one who had been employed by NIMH–who used ghostwriters “who have written entire sections of scientific publications” promoting Paxil, were awarded $66.8 million in NIH grants between 2006 through 20010.
POGO provides details about specific ghostwritten material penned by these six academics, accompanied by documents, including memos from the ghostwriter, Sally Laden (of STI), detailing submissions for publication prepared by her. These memos are part of GSK’s copious Paxil documents which were uncovered during litigation and are now in the public domain. Prominent among these, are documents relating to the pediatric Paxil trial–known as, “study 329”, published in 2001.
This notorious study, was the catalyst that led (then) New York State Attorney General, Eliot Spitzer, to sue GlaxoSmithKline for fraud (2004). The suit, specifically charged GSK with misrepresentation of the study findings, by claiming that Paxil was “generally well tolerated and effective for major depression in adolescents.” Whereas the evidence showed that the drug did not benefit children–AND it increased the risk of SUICIDE. But, those published fraudulent claims were penned by prominent academic psychiatrists who have not, so far, been held accountable.
Until the fraud was brought to light, Paxil was the best-selling antidepressant in the world, sales in 2002, reached $3.3 billion.
Subsequent litigation uncovered documents revealing that a very large corps of prominent academic psychiatrists had collaborated with GSK in its deceptive marketing practices, which these academics helped camouflage as science. Yet, the NIH did not see fit to take action to ensure taxpayer dollars were not implicated in research fraud.
POGO makes the reasonable demand that 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.”
One of the co-“authors” of the discredited Paxil study 329, psychiatrist Stan Kutcher, ran for Canadian Parliament earlier this month. When a small Canadian newspaper, The Coast, published a factually verifiable story that revealed Dr. Kutcher’s role as an academic who penned his name as “co-author” of a ghostwritten report, he threatened to sue.
Canadian law, apparently shields politicians from libellous allegations before elections, but doesn’t distinguish between slander and verifiable, documented facts. So, when threatened by Dr. Kutcher with legal action, The Coast retracted the story and issued an apology . The original cached copy is here.
Read more here POGO and here Pharmalot about how Kutcher used the infamous Scientology grenade in an effort to discredit a reputable investigative reporter, Alison Bass, the author of the award winning book, Side Effects in which she documents in detail the magnitude of corporate / academic corruption. She was alerted about the scientific and ethical in Study 329. Dr. Kutcher lost the election by a wide margin.
Vera Hassner Sharav
November 29, 2010
Revised December 22, 2010
Francis S. Collins, M.D., Ph.D.
National Institutes of Health
One Center Drive
Bethesda, Maryland 20892
Via email: Francis.Collins@nih.hhs.gov
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.
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.
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 who have written entire sections of scientific publications. These documents were made public during litigation 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 portions of a handbook 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.
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.
Drs. Alan Schatzberg and Charles Nemeroff
NIH funding since FY 2006: $23.3 million
NIH funding FY 2010: $2,374,242
STI also authored entire portions of a physician handbook, 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 handbook 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 handbook. Her timeline states that she would write the first draft, which then would be sent to Drs. Nemeroff and Schatzberg, the publisher, and GlaxoSmithKline. The timeline also notes that GSK would receive all three drafts and page proofs for final approval. (Attachment E)
However, in the book’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 apparent involvement in drafting the handbook, including sign-off of page proofs as laid out in STI’s timeline, undermines the assertion that the company’s grant was “unrestricted.” Based on the evidence available to POGO at this time, the nature and extent of GSK’s actual involvement is undetermined.
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.
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.
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. 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.”
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. In May 2004, our own FDA issued a similar warning.
In early 2007, the BBC’s investigative program Panorama released a documentary on Paxil and Study 329. 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. One email read, “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results.” 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.” (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…” 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.”
Even Brown University’s student newspaper, The Brown Daily Herald, published an exposé on Dr. Keller’s research and Study 329. 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.” 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.
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. The study’s authors concluded that “medical ghostwriting is a threat to public health….”
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 email@example.com.
 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)
 “Newsmakers with Dr. Francis Collins,” C-SPAN, December 21, 2009. (Downloaded November 19, 2010)
 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).
 Mount Sinai School of Medicine, “Dennis S. Charney.” (Downloaded November 22, 2010)
 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”)
 NIH RePORTER.
 NIH RePORTER.
 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)
 Study 329, pp. 762-772.
 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)
 Food and Drug Administration, “Dear Healthcare Professional,” May 2004. (Downloaded November 19, 2010)
 “Secrets of the Drug Trials: Transcript,” BBC One: Panorama, January 29, 2007. (Downloaded November 19, 2010) (hereinafter “Secrets of the Drug Trials: Transcript”)
 “Secrets of the Drug Trials,” BBC One: Panorama, January 29, 2007. (Downloaded November 19, 2010) (hereinafter “Secrets of the Drug Trials”)
 “Secrets of the Drug Trials.”
 “Secrets of the Drug Trials.”
 “Secrets of the Drug Trials: Transcript.”
 Alison Bass, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, Chapel Hill, North Carolina: Algonquin Books of Chapel Hill, 2008.
 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)
 “Accountable Academics,” The Brown Daily Herald, September 24, 2008. (Downloaded November 19, 2010)
 NIH RePORTER.
 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”)
 “Ghostwriting at Elite Academic Medical Centers in the United States.”
POGO’s first reply to letters from Dr. Schatzberg and Dr. Nemeroff, December 8, 2010.
POGO’s second reply to letters from Dr. Schatzberg and Dr. Nemeroff, December 9, 2010.
POGO’s third reply to letters from Dr. Schatzberg and Dr. Nemeroff, December 16, 2010.
POGO’s fourth reply to letters from Dr. Schatzberg and Dr. Nemeroff, December 23, 2010.