FDA probes "misleading" journal article

Medical Marketing and Media, Aug 2002

The FDA is looking into whether Pharmacia Corp. knowingly disseminated an allegedly misleading journal article on Celebrex (celecoxib), according to a senior agency official. The official was responding to an editorial in the June 1 issue of the British Medical Journal criticizing a September 2000 article in JAMA that selectively reported on six-month data from Pharmacia's CLASS study when longer term data (12 and 15 months) were available that showed less-favorable results than were reported in JAMA.

Over 30,000 reprints of the JAMA piece have been disseminated, helping to boost Celebrex's sales to over $3 billion annually, the editorial noted. "Reprints are a complicated issue and we carefully evaluate all materials that may be misleading in the promotion of prescription drugs," the FDA official said.