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
Health Beat by Maggie Mahar
