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Wyeth's Hired Hands
As James notes in the thread below, there is an unusually detailed article in today's NYT about the extent of ghost-written articles used to promote the use of Prempro, including numerous meta-analyses, etc. Nothing new about ghostwriting. But what seems unusual (but may not be) here is the extent of it, creating the illusion of medical consensus, as well as the role of the journals themselves and their publisher in all of this.
http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1&emc=tnt&tntemail1=y
Wednesday, August 5, 2009
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Since Wyeth was the poster company for FDA preemption, it is worth noting that, however misrepresenting any of these articles were (and they may or may not have been), their publication would have been out of FDA's jurisdiction.
ReplyDeleteSpeaking generally, the point is that almost all the degree of fraud that may go on in journal publishing are within FDA's purview.
But they are within the purview of civil suits.
Thus, even if we had a utopian FDA (dream on),
it would not cover the same potential delinquencies that civil liability does.
Intimidating or bribing researchers, for example, are other areas entirely outside of FDA.
Whoops. First sentence of par. 2 above, should have swaid "_not_ within FDA's purview."
ReplyDeleteMy Reply to the NYT Editor:
ReplyDeleteGhost writing is only a part of the problem with the Pharmaceutical Industry. The fact that the pharmaceutical industry is allowed to release only studies that support the efficacy of their drugs does not provide consumers the necessary information to make a truly informed judgment about the risks and benefits of new therapies.
The FDA through the withholding of so-called proprietary information also enables the pharmaceutical industry to engage in deceptive practices. The FDA's primary purpose is to protect the American public from unsafe practices. Who knows how much of this so-called proprietary information is actually at odds with the FDA's stated mission purpose.
We know, all too well, that under the previous Administration the main goal of the FDA was to give somewhat dubious medications the US Government's stamp of approval.
Finally, in their defense the pharmaceutical industry and Wyeth in particular, will spin the recent release of the negative information associated with their assorted treatments and point to the fact that they have prevailed in the majority of the court cases questioning these treatments. In addition they will use their success in court as further proof that preemption statutes are required. In this last statement just remember Wyeth is the same company that brought the American Public Phen-fen and were promoting its use even after they were aware of the consequences associated with its use.
Dr. Carlat says it very well:
ReplyDelete“Actually, the proper collective response from all of these participants [ghostwriters] should have been: ‘We sincerely apologize for having deceived the medical community by engaging in ghostwriting without disclosure. We have contributed to the erosion of the public's trust in medicine, and we regret it.’" - http://carlatpsychiatry.blogspot.com/
That I'd like to see (Carlat's line).
ReplyDeleteBut, as James points out, if the info is essentially fraudulent, the ghostwriter him/herself is usually a small link in a longer chain of deceit. As the article points out, the outline and points to be made all came from Wyeth. The ghostwriter is only someone who put a few sentences together.
Then you have the guestwriters, named docs, who are certainly more culpable, even if the article turns out to be accurate. Definitely bigger whores.
What do we say about the role of Elsevier, the publisher of many of these journals, in all of this? They certainly profit from the steady stream of ghostwork.
ReplyDeleteHere's a perspective on ghostwriting from "inside" the industry. Hardly anyone thinks that this is an acceptable practice...
ReplyDeletehttp://pipeline.corante.com/archives/2009/08/06/ghostwriting.php
From Nathan’s blog reference that is meant to support the idea that hardly anyone agrees with ghostwriting, a poster by the name of Hap writes –
ReplyDelete“2) I assume that the marketing people (and their bosses) don't understand that trust and integrity aren't infinite resources, that they are very quickly exhausted, and that they are very hard to regain once lost. Once people can't trust you, it's much easier to demonize you, because you've traded in much of your (good) humanity for cash, and what's left is the humanity we'd prefer not to acknowledge. Do they think their lack of integrity will help them to sell drugs, or do they not think they'll be in the business for long and so don't care about conscience or consequences? “
So given Nathan and Hap’s statements, which I agree with totally it appears that we have an industry that knows what is right but still does wrong.
One thing that I disagree with from Hap’s post is the idea that marketing people don’t understand the value of trust and integrity. Only an inept marketing department would endanger consumer trust. Nothing can be sold without it.
So where is the directive to employ ghost writers really coming from?
Just on David's last question, I think what we've seen over the past twenty years or so is a general "take-over" of the industry from the marketing side (understanding it's more complicated). But we see the same organizations--essentially ad agencies--being involved in all phases of drug development: from initial trials, to hiring CROs, to working with FDA, to promotion, etc.. It has also been people from that culture who are more likely to become CEOs.
ReplyDeleteGhosts are a small bit of that. And, as noted elsewhere, one can't discount the role of journals and their publishers as part of the octopus.