Category Archives: Drugmakers

Drug-Maker’s Direct-to-Consumer Advertising—“Half-True”?

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Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .  information currently being advertised could mislead the public.”

But “don’t get too excited that the U.S. Food & Drug Administration has regained its sanity,” says blogger Bill Sardi.

“This is the FDA in Thailand,” he explained. (Sardi picked up the news in the Bangkok Post)

Before taking a closer look at precisely why Thailand’s health officials  are concerned about Merck’s ads—and why our own FDA isn’t raising a red flag– let’s step back and review our own government’s policy on drug ads that are beamed directly to you and me.

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Wall Street, Cancer and the FDA: A Cautionary Tale

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Only in America do physicians who evaluate new drugs need bodyguards. You may have read about the brouhaha surrounding Provenge, a vaccine designed to extend the lives of men suffering from late-stage prostate cancer. In March, a Food and Drug Administration (FDA) advisory panel voted 13 to 4 to recommend approval. The next day, shares of Dendreon, the drug’s sponsor, doubled. But shareholders did not celebrate for long. Two of the dissenting votes were cast by the panel’s two prostate cancer specialists: Sloan-Kettering’s Howard Scher and the University of Michigan’s Maha Hussain. And they did not just vote “no”—following the hearing, both wrote to the FDA arguing that Dendreon offered no solid evidence that Provenge works.
   
The FDA listened. And in May it told the company it wouldn’t approve the drug until it had more data. That is when the two oncologists began receiving threatening e-mails, phone calls, and letters. Many were anonymous

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