The steaming controversy over Provenge - whether the prostate-cancer vaccine should be approved; the two FDA advisory panelists who went out of their way to delay agency approval; threats made to the two docs; and outrage among cancer patients and biotech investors - isn’t going away anytime soon. In fact, it resurfaced this morning on the front page of The Washington Post.
For those following this mess, the story didn’t really add much. For those who were unaware, though, the Post provided a good round-up, complete with significance and the bitter remarks of Maha Hussain, one of the FDA panelists, who fears for her safety. Both she and the other dissenting doc, Howard Scher, required private security at a recent meeting of cancer docs, for instance.
Here’s the quickie backdrop: the FDA panel this spring voted that Dendreon’s Provenge was safe and effective. The two docs weren’t convinced, though, and wrote the agency about concerns they had with Provenge trials, triggering the FDA delay. The stock, meanwhile, was gyrating. And cancer patients and their families were outraged, prompting protests and Internet missives.
Their fury was stoked, in part, by disclosures that Scher and Hussain had conflicts of interest. Scher (pictured to the left) has ties to other drugmakers - such as AstraZeneca and Sanofi-Aventis - with cancer meds. He’s also lead investigator for Novacea’s prostate cancer drug. And a patient group, ProvengeNow, cites info that Hussain was on Novacea’s advisory board. However, Novacea spokesman Paul Leland says the only tie to Hussain was a one-time fee she was paid for reviewing trial data two years ago.
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