NEW YORK |
NEW YORK (Reuters) ? Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy.
Doctors who raised doubts about it received death threats. Health regulators and lawmakers faced loud protests at their offices. A physician at the American Cancer Society was so intimidated by Provenge partisans that he yanked a skeptical discussion of it from his blog.
The vitriol dissipated in April 2010, when the U.S. Food and Drug Administration approved Provenge for advanced prostate cancer, satisfying investors in manufacturer Dendreon and patients who for years had demanded it be put on the market.
But the bell on Round Two sounded when Marie Huber, a trained scientist and former hedge-fund analyst, made it her mission in the last year to analyze what she believes are deadly flaws in the studies that led to the approval of Provenge by the FDA.
She argues that the main reason Provenge seemed to extend survival ? a crucial factor in the FDA?s decision ? was that older men in the study who did not receive Provenge died months sooner than similar patients?
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Source: http://www.oddonion.com/2012/03/30/insight-new-doubts-about-prostate-cancer-vaccine-provenge/
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