Wednesday, August 19, 2009

Ghostwriting in drug research back in the spotlight

It's good to see The New York Times maintain a spotlight on the widespread practice of ghostwriting in drug research. In her article today, Natasha Singer focuses on Wyeth's use of a ghostwriting firm to prepare an estimated 60 articles favorable to its hormone drugs.

Wyeth's use of ghostwriters to prepare favorable studies and then find doctors willing to put their names on them is, of course, only the latest in a long string of drug industry campaigns to present new products in the most positive light possible. The makers of the SSRI antidepressants were masters at this tactic. As I reveal in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here. Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents.

Why were the authors of study 329 so lax in attaching their names to a study they didn't write? Could it have had anything to do with the fact that Keller and several of his co-authors were getting paid huge amounts of money in consulting and speaking fees by GlaxoSmithKline?

In its marketing of Zoloft, another blockbuster SSRI antidepressant, Pfizer did much the same thing, as I've reported in previous blogs here.

Hence, I'm glad to see that the Senate Finance Committee seems to be putting pressure on the National Institutes of Health to crack down on the practice of ghostwriting and undisclosed conflicts of interest; see letter from Senator Grassley here. As Singer notes, active enforcement by the NIH is crucial since "many of the nation’s top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines..."

Up till now, NIH has been reluctant to take a more pro-active role on the issue of ghostwriting or do much to enforce its own conflict of interest policy (which has been on the books since the mid-90s). So I'm eager to see how Frances Collins, the new director of NIH, handles the issue. Stay tuned...

1 comment:

Dan said...

Ghostwriting is only one of distrubing elements of publication planning by typically big pharma. There are also CROs and IRBs, both of which are for profit and are paid for the sponsor.

Incentives for the investigators participating in clinical trials.

Bribing medical journals with, aside from cash, buying ad space and tens of thousands of reprints from such a journal who agrees to publish not findings, but hidings.

PLOS journal did a really good study on this very issue that needs to be stooped, yet it continues.