Ghostwriters in the Sky

I know it’s April 1 – but believe me, this is no joke…

This information is from 2002 – thanks due once again to the (literally) tireless work of Truthman30 – make sure you put his blog GSK : Licence To (K)ill on your list to visit regulary.

What we’re talking about here is ghostwriting – Doctors and Key Opinion Leaders (KOLs) being paid by Glaxo to put their names on papers which purportedly analyse the data of clinical studies involving company products. Of course, the conclusions drawn from such ‘analysis’ are always positive and are then used to as part of the marketing of said drug. One of Glaxo’s favourite KOLs is ‘Marty’ Keller – just follow this link to find much, much about him!

Dr. David Dunner of the University of Washington’s Department of Psychiatry admitted he “ghostwrote” an article that appeared in the March 1995 issue of the journal European Neuropsychopharmacology (EN) on behalf of pharmaceutical manufacturer SmithKline-Beecham (which has since merged with GlaxoWellome to become Glaxo-Smith-Kline, or GSK). Dunner had purportedly analyzed the data of clinical studies involving GSK’s antidepressant and anti-anxiety drug Paxil and concluded that it is less likely to lead to suicidal thoughts than the older antidepressant imipramine or a placebo(sugar pill).

Dunner never looked at any of the data but he was still listed as an “author” of the article.

Meanwhile, Dr. David Healy of the University of Wales Department of Psychological Medicine presented a different analysis of this same data during the Paxil trial [of 2001]. The family of Wyoming resident Donald Schell, 60, sued GSK in federal court after Schell shot his wife, daughter, granddaughter and then himself to death in 1998 after two days on Paxil. Healy testified on behalf of the plaintiffs. He argued GSK’s internal records demonstrated that there is a substantially increased suicide risk for patients put on Paxil. The jury agreed with the plaintiff’s position that Paxil was primarily responsible for Schell’s actions and awarded them $6.4 million in June of [2001]. The judge in the case rejected GSK’s challenge of Healy’s testimony and sent them packing to a federal appeals court in Denver in August.

A suicide warning has since been put on the label for the drug, not here in the United States, but in Britain, where it is known as Seroxat.

Dunner’s record also includes eight statements of significant financial interest. The most significant with regard to the Paxil clinical trial data is a disclosure he made in 1998. The disclosure was made regarding an application for a clinical trial dealing with Paxil in which Dunner would serve as an investigator at his Center for Anxiety and Depression. His Confidential Statement to the Vice Provost for Research states, “My involvement with SmithKlineBeecham (the pre-Glaxo merger owner of Paxil) involves being a member of the international advisory board related to paroxetine (Paxil).” In other words, Dunner’s name appeared in the EN article not as an independent scientist but most likely as a part-time employee of the manufacturer of Paxil. This conflict of interest is not mentioned in the EN article.

Here is Dunner in his own words… “I don’t know who saw it (the Paxil clinical trial data). I did not. My role in the paper was that the data were presented to us and we analyzed it and wrote it up and wrote references.” Dunner’s co-author Stuart Montgomery, then of St. Mary’s hospital medical school in London, declined comment for the Guardian article. His other co-author is Geoff Dunbar, a company employee (Dunbar’s status as a SmithKline employee was mention in the EN article).

You can read the full article here.

Last words to David Healy:
“The fact that (pharmaceutical) companies have chosen to market them as antidepressants rather than agents of agitation is a business decision rather than a scientific matter…”

No, actually last words to me: how long is this going to be allowed to go on?

We have the history of Seroxat ghostwriting documented and now Glaxo are doing EXACTLY the same thing with the newest anti-depressant they want approval for – Gepirone ER – see here, here and here.

3 Responses to “Ghostwriters in the Sky”

  1. Matthew Holford Says:

    Perhaps it’s worth writing to these people, and asking them, in all seriousness, what it was that led them to understand that Seroxat was valuable. If Shelley Jofre’s experience is typical, any such enquiries will be referred to GSK.

    Now, if GSK is the instigator of all this dubious behaviour (ie, the MHRA and DoH’s silence, dubious analysis, and so on), then GSK is going to have a lot of work on its plate. Indeed, it might have to employ a sizeable workforce, not to manufacture and promote its drugs, but to co-ordinate the “truth”, which would also explain the lengthy delay in receiving responses, even to closed (yes/no) questions, from the MHRA. Although, clearly, this is merely a possibility, not a fact.

    I think I might track me down some email addresses for these people, and draft up a letter, of some sort. I imagine Simon Bicknell would be pleased to receive a copy, too, concerned as he is with the highest standards of corporate governance.

    Matt

  2. seroxat secrets… The Drug Pushers - 2 « Says:

    […] Thought leaders serve an indispensable function when it comes to a potentially very lucrative marketing niche: off-label promotion, or promoting a drug for uses other than those for which it was approved by the FDA—something reps are strictly forbidden to do. The case of Neurontin is especially instructive. In 1996 a whistle-blower named David Franklin, a medical-science liaison with Parke-Davis (now a division of Pfizer), filed suit against the company over its off-label promotion of this drug. Neurontin was approved for the treatment of epilepsy, but according to the lawsuit, Parke-Davis was promoting it for other conditions—including bipolar disorder, migraines, and restless legs syndrome—for which there was little or no scientific evidence that it worked. To do so the company employed a variety of schemes, most involving a combination of rep ingenuity and payments to doctors. Some doctors signed ghostwritten journal articles. One received more than $300,000 to speak about Neurontin at conferences. […]

  3. seroxat secrets… The profitable anti-Seroxat bandwagon… « Says:

    […] Ah, the evidence. It matters not a jot what I, and tens of thousands of others like me have gone though, – that just doesn’t count. The big pharma apologists want key opinion leaders, studies, meta analyses, publications in peer reviewed journals – maybe like Study 329 and Dr Keller, perhaps? Ghostwriting, anyone? […]


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