How Pharma Stacks the Deck with Medical Journals

Some once-friendly ghosts may be getting Merck in trouble all over again.

The ethereal beings in question are ghostwriters -- the nameless, faceless freelancers paid by drug companies to draft up medical review papers, usually well before they're even seen by the academic researchers who will eventually put their names on them. Paid ghostwriting of ostensibly independent drug studies has been a growing issue for Big Pharma in recent years, as medical-journal editors began to question -- so far, with few actual results -- whether it made sense to lend their imprimatur to manuscripts that effectively function as scientific press releases.

Back to the fray
The furor is starting up again thanks to the Journal of the American Medical Association, which earlier today published a (presumably non-ghostwritten) study that examined thousands of documents related to Vioxx, the painkiller Merck withdrew four years ago after evidence linking it to heart attacks emerged. Those documents emerged as a result of major litigation against the drugmaker; not coincidentally, all four authors of the study have also served as paid consultants for plaintiffs in those suits. (One author, interestingly enough, is Yale professor Harlan Krumholz, who was last seen blasting Merck and Schering-Plough for their handling of the anti-cholesterol drug Vytorin.) On the other hand, the documents the team relied on are all published online at the UCSF Drug Industry Document Archive, so readers are free to check everything out for themselves.

And those findings are pretty sweeping. Review articles about Vioxx were often prepared by "unacknowledged authors" -- medical ghostwriters -- for instance, but later attributed to academics. Why? "Experienced authors know that the initial draft (in this case paid for by Merck) sets the tone for the manuscript," JAMA's top two editors wrote in an accompanying editorial.

Reports on clinical-trial results were frequently first written by Merck employees and -- you guessed it -- later credited to university researchers. The ghostwriting work could be quite lucrative, too: One invoice by a New York "medical publishing" firm called HealthScience Communications billed Merck $23,841 for a 20-page, double-spaced draft article (PDF link) about Vioxx -- some $15,000 of which was slated directly for the writing itself.

Merck immediately denounced the study as "false" and "misleading." None of these shenanigans, however, should come as any surprise to anyone who's watched pharma spend more than a decade putting its words into the mouths of patients (via direct-to-consumer advertising), doctors (via "thought leader" consulting contracts) and legislators (via lobbying). In fact, it's enough to make you wonder if pharma executives consider this tactic such a standard operating procedure that they simply can't see the problem in apparently creating minutes for a key meeting a month after the fact, even while under congressional investigation.

JAMA gets radical
What did surprise me was the extent to which the JAMA editors appear to be fed up with Big Pharma's influence over medicine, as exemplified by 11 proposals they offer to limit corporate involvement in medical information and decision-making. These start with obvious and familiar steps such as forcing authors to identify their contributions to a paper and disclose financial ties to drug and medical-device makers.

But where your classic medical-journal editorial might stop -- perhaps closing with a bit of vague hand-wringing over the need for physicians to preserve "public trust" in medicine -- JAMA Editor-in-Chief Catherine DeAngelis and Executive Deputy Editor Phil Fontanarosa instead go for the jugular. No drugmaker, they argue, should be "solely or primarily involved" in collecting or analyzing data even from its own clinical trials, and independent statisticians should conduct all data analyses. Researchers who act unethically, whether as authors or as peer reviewers, should be reported to their academic employers and possibly banned from publishing in or reviewing for journals.

Finally, and most radically, DeAngelis and Fontanarosa endorse a complete ban on industry sponsorship of continuing medical education -- the courses doctors must take regularly to keep their licenses -- and on gift-giving to physicians. (Both present obvious opportunities for companies to hawk drugs and manipulate physicians' prescribing behavior.) These are ideas that the medical community has largely managed to restrict to the fringes of polite discourse up to now, so it will be worth watching to see if the JAMA editorial advances the conversation at all.

For more on the JAMA studies, including one I haven't addressed that looked at whether Merck deliberately understated the risk of death when it tested Vioxx among Alzheimer's patients, check out Pharmalot or the WSJ Health Blog. Meanwhile, the JAMA editorial is also interesting to consider in light of a separate NYT piece this morning on doctors who have decided to forgo drug-industry funding altogether. That article is pretty thin on its merits -- it profiles only three doctors, one of whom made his decision a decade ago, and includes no data suggesting whether the trend is real or not -- but it's an interesting indication of where the NYT thinks the Zeitgeist is heading.

UPDATE: And in the next turn of the screw, Big Pharma scourge Charles Grassley, a Republican senator from Iowa, is already firing off letters to Merck and one of the ghostwriting firms, Scientific Therapeutics Information, demanding information about the Alzheimer's study and details of the ghostwriting activities. (Hat tip: Pharmalot.)

(Photo of "Return of the Ghost Writers" by Flickr user JJ & Special K, used under Creative Commons.)