Pro/Con on FDA off-label proposal

One of the things media love to do is get two people to go head-to-head on an issue. Today's topic: Allowing drugmakers to distribute peer-reviewed journal articles in support of off-label uses for their products. On the pro side is Scott Gottlieb (photo [1]), an ex-FDA deputy commissioner who's now at the conservative American Enterprise Institute. Former New England Journal of Medicine editor Jerome Kassirer is on the con side.

Gottlieb argues that allowing distribution of peer-reviewed articles would set a "measured standard as to what information could help better inform decisions that doctors make with their patients." Using the cancer med Herceptin as an example, Gottlieb says an "information gap" kept doctors from prescribing the med to women who could benefit from the drug. Government-funded studies in 2005 showed Herceptin could help cut the risk of relapse; it was approved for breast cancer use two years later.

Kassirer, however, says that peer review isn't enough of a guarantee. Not all peer review is equally stringent, for one thing; articles rejected by top journals often find a place at lesser pubs with less-exacting standards. Also, some studies are designed just to raise questions for further research. "The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking," Kassirer contends. The proposed practice would simply lead to more inappropriate drug use and "more adverse consequences," he states.

- see the item [2] at the Wall Street Journal Health Blog
- check out Pharmalot's coverage [3]
- get the full commentary [4] at Health Affairs

ALSO: What does a bioethicist think about the ghostwriting scandal [5] that erupted a couple of weeks ago? "All papers must originate with a scientist or scientific author who's done the study," Art Caplan of the University of Pennsylvania told Pharmalot. But, he said, he thinks there's probably a role for third-party writing help--after the first draft. Report [6]

Related Articles:
JAMA thumbs-down for off-label proposal [7]
Ex-Pfizerite indicted in off-label case [8]
Rep decries off-label marketing "loophole" [9]
Should off-label journal promos be OK? [10]