JAMA Offers Chance Not to Blog About ENHANCE Study

Thanking God and Catherine DeAngelis (and trying not to confuse the two), the Pathophilia blog embraces the opportunity to post about something other than the ENHANCE study.

I'm referring to the already-heavily-blogged-about case study in today's issue of JAMA, which examined Merck's use of academic guest authors or contract ghostwriters. The study's authors were consultants for the personal-injury attorneys in the Vioxx-related litigation against Merck and therefore had access to the drugmaker's internal documents (which are now publicly available here).*

A primary conclusion of the case study is that Vioxx clinical-trial manuscripts were initially authored by Merck scientists, but that first authorship was later attributed to recruited, university-affiliated physicians—presumably to lend academic credibility or cache to the published studies. The numbers are difficult to pin down, but the JAMA case study identified 24 clinical-trial articles from 1999 on (which are referenced in a detailed table) and highlighted a few studies in the text, including an Alzheimer's trial that was not listed in the table (Thal LJ et al. Neuropsychopharmacology. 2005;30:1204-1215). Elsewhere, the authors identify 16 of 20 clinical-trial articles that were initially drafted by a Merck employee but were then published with an academically affiliated first author. In these cases, the Merck author was typically bumped to an anchor position.

The study authors also described documents revealing the outside contracting of a ghostwriter for one Merck study, "A randomized, placebo-controlled, parallel-group, double-blind study to evaluate the safety and efficacy of rofecoxib 25 mg and celecoxib 200 mg in patients with osteoarthritis of the knee or hip." However, a citation for the published article is not found. (The JAMA case study suggests that medical ghostwriting is, not surprising, more prevalent when creating review pieces.)

Although the intentions of the case-study authors may be well placed, it is troubling that they did not seek direct responses from Merck scientists or the cited academic authors before JAMA's publication of the piece—which is really more of a journalistic-type exposé than any report of scientific merit. (A few of the implicated academics have taken their umbrage to the NYT and other press outlets.) Also, in the full spirit of disclosure, the authors should have revealed their compensation as a result of the Vioxx litigation. If financial relationships with relevant drug manufacturers should be disclosed, then so should financial relationships with relevant plaintiffs' firms. 

*Evidently at the insistence of JAMA's chief editors, if DeAngelis and Fontanarosa are to be believed.