ghostwriting

Merck swears off ghostwriting in settlement

Tracy Staton — Wed, 21 May 2008 10:37:00 -0400

Merck made a $58 million deal to settle claims of deceptive Vioxx advertising with a 29 attorneys general. The states had alleged that Merck deceived consumers by concealing the "increased risks" linked to the now-withdrawn painkiller. Of course, $58 million pales next to the $4.85 billion Merck has agreed to pay to Vioxx patients (and survivors) who can prove they had heart attacks, strokes, or other serious side effects.

One interesting facet of the deal: Merck has pledged to give up ghostwriting. Yep, that's right--about a month after the Journal of the American Medical Association said some published Vioxx studies were written, not by their prestigious bylined authors, but by hired guns, Merck is promising not to do that anymore. At the time, Merck defended the practice, saying the JAMA accusations were false and misleading. (And the company didn't admit any wrongdoing as part of the settlement, either.) For its part, the journal called ghostwriting--not just as practiced by Merck--"bad science and bad research practice." We wonder whether other drugmakers might volunteer to go cold turkey, too.

- see the WSJ Health Blog item
- check out the article in the Star-Ledger
- read the Washington Post story

JAMA thumbs-down for off-label proposal

Wed, 23 Apr 2008 06:59:56 -0400

Considering the ghostwriting scandal it touched off last week, it's not surprising that the Journal of the American Medical Association this week lambastes an FDA proposal to allow drug makers to hand out journal articles that support off-label uses of their products.

JAMA's reasoning? Well, apart from the ghostwriting it highlighted last week--in which drug makers hire folks to write journal articles--there's the issue of selective publication. As studies have shown, positive trials are printed more often than negative ones. And even if those two kinks were ironed out, "the knowledge base of published studies would often be inadequate to evaluate off-label use."

The FDA thinks it's answered some of these concerns in the draft guidelines for article distribution. And drug makers are lobbying hard for the new rules. But JAMA isn't the only dissenting voice. We'll see how the debate shakes out.

- see the WSJ Health Blog item

ALSO: Connecticut AG Richard Blumenthal asked the state legislature to ban pharma gifts to doctors, saying that the industry has too much influence over healthcare decisions. The industry's own marketing code is meaningless and unenforceable, he said. Report

Ghostwriting fuels foes of FDA rule change

Mon, 21 Apr 2008 06:59:56 -0400

Last week, we reported on Big Pharma's march on the capital in support of new off-label marketing rules. Now, opponents of those rules are drawing on another of last week's news events for support: the Vioxx ghostwriting story.

You'll recall that last week's Journal of the American Medical Association included an article showing that Merck used ghostwriters to produce journal articles supporting the now-withdrawn painkiller Vioxx. You'll also recall that the proposed FDA rules would allow drugmakers to distribute journal articles supporting off-label uses of their products.

Critics of the proposal say that if the credibility of journal articles can't be guaranteed--and in fact might have been skewed by the drugmakers--then why should they be exempt from off-label marketing prohibitions? Even before the Vioxx story broke, Blue Cross Blue Shield had written the FDA to question the marketing proposal, citing the possibility that ghostwritten articles could be used to bolster off-label uses, the New York Times reports. And New York State's health commissioner weighed in with similar concerns, referring to Pfizer's use of journal articles to promote off-label use of Neurontin; Pfizer later paid $430 million to settle off-label marketing claims. (Funny, there was a Neurontin story last week, too.)

"We just have so many concerns," Commissioner Dr. Richard F. Daines told the NYT. "You don't know the publication's true peer-review standards and transparency."

- read the NYT story

Related Articles:
JAMA: Merck paid docs for bylines. Ghostwriting report
Could full data disclosure avert scandal? Report
Positive data more likely to find its way to public. Report