New FDA reads journal reprints differently

Drugmakers may be able to tout their products with journal reprints, but even if an article supports an FDA-approved use, it could earn its distributor a kick in the pants. Poor Sanofi-Aventis got to be the guinea pig on this one: FDA cited the drugmaker for a reprint carrier that allegedly exaggerated the benefits of its breast cancer remedy Taxotere--even though that reprint cited the enclosed journal article.

The article appeared in that not-so-obscure little review the Journal of Clinical Oncology. It reported a study of Taxotere--and in the process suggested that the Sanofi med was better than rival Taxol (branded by Bristol-Myers Squibb, plus available as a generic). Naturally, Sanofi cited those results in its reprint wrapper.

And therein lay the rub, FDA says: "These claims misleadingly suggest that Taxotere is superior to paclitaxel in the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy," the agency wrote, "and overstate the efficacy of Taxotere. FDA is unaware of substantial evidence to support these claims." The enclosed study results weren't statistically significant, endpoint-wise, so further analysis of the same data doesn't count as evidence, FDA said. Plus, no one has ever replicated this trial's results. Strike Two.

Sanofi is protesting, saying that it believes the journal article is an appropriate marketing tool "based on current FDA promotion and advertising regulations," Reuters reports. (An aside: The company has already stopped using materials about the study discussed in that article, known as TAX 311.) We're wondering whether those regulations will change. And we'd like to know if FDA is signaling that drug marketers have to apply a bit more scientific rigor to their reading of journal articles.

- see the letter from FDA
- read the Reuters story

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