JAMA thumbs-down for off-label proposal

Considering the ghostwriting scandal [1] 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 [2]--there's the issue of selective publication. As studies have shown, positive trials are printed more often than negative ones [3]. 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 [4]

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 [5]

Related Articles:
Ghostwriting fuels foes of FDA rule change [1]
JAMA: Merck paid docs for bylines [2]
Could full data disclosure avert scandal?
Positive data more likely to find its way to public [3]