The Professor, A Paxil Study & Misconduct Charges
7 CommentsBy Ed Silverman // July 12th, 2011 // 1:45 pm
A University of Pennsylvania psychiatry professor is alleging that several colleagues - including his department chair - allowed their names to be added to a medical journal manuscript but gave control of the contents to GlaxoSmithKline. The study, which was funded by the drugmaker and the National Institutes of Health, looked at the impact of the Paxil antidepressant on patients with bipolar disorder.
Moreover, the professor, Jay Amsterdam, also claims the 2001 study, which was published by the American Journal of Psychiatry (see here), was ghostwritten by Scientific Therapeutics Information. The same firm has previously been cited for ghostwriting activities in connection with Paxil, including a book that was published in 1999 by the American Psychiatric Association (read this). The published study did not acknowledge that STI played any role.
And so, Amsterdam, 62, has filed a complaint with the federal Office of Research Integrity charging scientific misconduct. In a letter to the ORI, he alleges “the published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil.” He also claims he was a co-principal investigator, but was excluded from the final data review, analysis and publication (here is the letter).
The letter accuses the published authors of engaging in scientific misconduct by allowing their names to be attached to the study, which has since been cited more than 250 times over the past decade (here is a partial list). The lead author was Charles Nemeroff, who was a poster boy for undeclared conflicts of interest among academic researchers (see this) and a purported co-author of the ghostwritten book.
Along with the letter, Amsterdam attached numerous documents that he sent as evidence that “most, if not all” of the authors were chosen by Glaxo. The documents indicate that Amsterdam, who actively enrolled many patients in the study, protested his exclusion from the review and publication to another of the authors, Dwight Evans, who chairs the Penn psychiatry department, and was his supervisor.
The protests failed. As Amsterdam wrote at one point, he was met with “radio silence” (read this). Although in one letter written in April 2001 to Amsterdam, Karl Rickels, who was chief of mood and anxiety disorders section at the Penn psychiatry department, acknowledged that, “apparently these participants never had a chance to review or even just see the
manuscript” (see here).
Rickels also wrote him that STI chose another colleague, Laszlo Gyulai, another Penn psychiatrist, as the paper’s first author and that Glaxo then decided to replace him with Nemeroff. In addition to Nemeroff and Evans, Amsterdam also charged misconduct was committed by Gyulai, who is now retired; Gary Sachs, a psychiatrist at Massachusetts General Hospital in Boston; and Charles Bowden, chairman of psychiatry at the University of Texas Health Science Center in San Antonio.
A Penn spokeswoman writes us that an investigation will take place and both Evans and Gyulai “have been advised of the allegations in the complaint and while they believe them to be unfounded, have made clear to the university that they will fully cooperate with the investigation”. Bowden tells Nature: “I provided input that was incorporated into the manuscript…I never had any sense that the manuscript was ‘ghostwritten’.”
A Glaxo spokeswoman writes us to say that Glaxo employees were involved developing the manuscript and were listed as authors…but the “article was written more than 10 years ago and we do not have details about the development of the manuscript.” She adds that Amsterdam’s involvement in the study is noted in the acknowledgments section of the published manuscript.
“The proper use of medical writers serves a legitimate role in facilitating the timely analysis and presentation of clinical trial data for public consideration,” she writes, adding that Glaxo is committed to transparency in c. “They may assist with assembling or preparing initial drafts, tables and figures, collating co-author comments and revising the document to incorporate those comments….”
Meanwhile, the Project on Government Oversight, a watchdog group that has tracked the NIH and conflicts of interest, wrote President Obama this week to ask that Penn president Amy Gutmann be removed from her position as chair of the Presidential Commission for the Study of Bioethical Issues because she has not been tough enough on ghostwriting (read this and you can read more here on the POGO blog).
pic thx to mattwi1s0n on flickr
Charles Nemeroff
Not me again….
Ivan
Yes, you again… my what a long tail you have!
Basel lair
Bigpharma misconduct is all encompassing activity done deliberately and with approval from the very top of every bigpharma Co.It is very important part of their MO, period. Scientific (other side is business/promotional)misconduct is done for one purpose only, to support the misconduct on the businness side of bigpharma co\’s activity. When they have \"good\" data to support their claims for their drug, be they label or off-label they have much easier job of doing what they do, enhance their returns by all means, legal, illegal, ethical or unethical. So they would do all kinds of schemes with scientific community (professors et al)to secure data they want. Now something about professors: There is a professor at University of Toronto doing research and publication of papers on scientific misconduct of bigpharma.His name is Lemmans Trudo and if you are interested look up his work.However when the same prof was offered irrefutable evidence of miscondust on promo side of bigpharma, which is a natural extension of scientific one, he did not even make a comment re shocking disclosure of that side of misconduct.Two more professors involved in similar research (unethical stuff done by business types) when offered the same information, simply did not make even a sound let alone commented on the issue. I challenged one to make a comment and told her why she would not do it and still no comment. It seems professors as many others (politicians esp) are protecting their positions and careers and seem to be simply afraid to go against the big business like big pharma. So they stay the course, stay out of trouble and their research seems to be just to keep them in careers but not too step on anyone\’s toes. This In Canada at least where we can not fight the bigpharma as you do in USA with your wonderful FCA. We are trying to trigger interest for our version of FCA amongst our leaders(professors are out) and we are now at the stage of approaching politicians as they are doing in Australia. For those who may be interested look up \"Is Whistleblower Incentive Program Right for Canada?\" done by Y. Wang and the professor who sponsored this study is the one of those 3.
Quite sad but in democracy things do not change so easy even when there is a need so bad that is obvious to anyone but the dead.We need a champion and they are as rare as true champions in any sport. Any suggestions?
John M. Nardo MD
“The proper use of medical writers serves a legitimate role in facilitating the timely analysis and presentation of clinical trial data for public consideration,” … “They may assist with assembling or preparing initial drafts, tables and figures, collating co-author comments and revising the document to incorporate those comments….”
That blow-off might’ve flown even five years ago, but not now. Nemeroff? STI? Evans? GSK+Paxil? Give us a break! If they’re going to respond at all, how about, “Sorry.”
Paul Thacker and POGO are right to move the responsibility up to the level of the University President. If the purpose of the University executive is not to insure the integrity of the Academic Institution, there’s no reason to have an executive. It’s time for Amy Gutmann to “preside”…
Sam
Good for Dr. Amsterdam, Paul Thacker, and POGO. Perhaps by the time the smoke clears from this fire, others with integrity will step forward and work to clean house in the “profession” of psychiatry.
John
Ed, I may be a moral dunce, but I’m not entirely sure I understand the concern about this article being ghost written. The paper is not a review or an editorial, its a description of the results of a clinical trial. Over 75% of the article consists of a description of the trial design, numerical efficacy results, and the frequency of various side effects.
The critical question from my point of view is whether the article accurately reflects the consensus (you’ll never get this many academics to agree on anything 100%) viewpoint of the authors. This does not require that any of them actually spend time in front of a Word processor. Just ask my PhD advisor, who had me revise some of the papers I wrote for him 45 times until they exactly matched his rapidly shifting opinions.
If Dr Amsterdam was a legitimate contributor to the study and was excluded from reviewing the manuscript, that is clearly wrong. But my questions would be 1) Does “enrolling patients” qualify one as a co-author on a scientific manuscript (did he collect data and analyze it, or play an administrative role?), and 2) What is up exactly with coming out with this complaint a decade after the fact?
Evelyn Pringle
John - Amersterdam says: “the published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil.”
Plus it’s been sited over 250 times. It sound an awful lot like the Paxil Study 329 senario to me.