I had missed this one from Tuesday's New York Times—thanks to a reader for pointing it out to me: Expert Panel Gives Advice That Surprises a Drug Maker. A snip:
- Call it the advisory committee that keeps on giving advice.
After two medical studies questioned the safety of its popular heart failure therapy Natrecor, the Scios unit of Johnson & Johnson turned in April to a technique government and business often use to make problems go away: it formed an outside advisory committee.
Rather than the milquetoast findings often returned by such advisory panels, Dr. Braunwald's committee of 10 medical experts determined that use of Natrecor, an expensive intravenous therapy, should be strictly limited to acutely ill patients in hospitals. The committee asked Scios to begin warning doctors against the drug's use in outpatients, a treatment that had not been approved by the Food and Drug Administration but that had helped turn Natrecor into a big money maker.
Seeing as how the Justice Department in Boston is investigating the off-label promotion of Natrecor, they'd do well to heed the board's advice, which includes " ask[ing] for changes in company-sponsored medical education presentations about Natrecor."
The company appeared to be taken aback in June, though, when it learned just how fiercely independent its committee, led by Dr. Eugene Braunwald of Harvard Medical School, turned out to be.