An important new article in the New England Journal of Medicine takes a critical look at pharmaceutical companies for their Direct-to-Consumer (’DTC’) advertising of drugs. The piece by Dr. Miriam Schuchman, “Drug Risks and Free Speech — Can Congress Ban Consumer Drug Ads,” offers a fresh perspective on drug safety risks.
This is particularly important at a time when Vioxx was withdrawn from the market for being associated with coronary safety risks, followed by the recent NEJM report and FDA announcement that diabetics using Avandia had a 43-percent greater risks of heart attack risks than those not taking the GlaxoSmithKline drug.
What does this mean for Pfizer’s Exubera? Dr. Shuchman raises a point that this blog has reported on for over a year: that the FDA granted approval to put the inhaled insulin on the market, “despite the fact that safety studies are still under way.” She is a national correspondent for the NEJM.
Does this show greater caution at the FDA, or drug approvals as usual? It would not.
Take the example of Zelnorm, a drug that, until recently, was used to treat women with irritable bowel syndrome (’IBS’).
Dr. Schuchman says that Zelnorm sales benefited from DTC exposure while it was on the market for four (4) years. That was, until “the FDA withdrew it this past March because it didn’t consider the drug’s benefits sufficient to justify exposing patients to even low risks of a cardiac event.”
But Shuchman reports that “although the drug was only 5 to 10% more effective than placebo for women and was not shown to work at all for men, the belly-baring ad seems to have worked wonders: U.S. doctors wrote 2.1 million prescriptions for Zelnorm in 2005.”
That raises even more questions about Exubera when Pfizer launches DTC ads for the drug this summer. Despite poor Exubera sales, the advertising campaign could be a shot in the arm for Pfizer. Whether the drug will have adverse long-term effects on diabetics’ safety, however, is still an open question.
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