Maggie Mahar writes on healthcare, economics and public policy. Her work has appeared in The New York Times, Barrons, Institutional Investor and may other publications. A regular contributor for THCB, her most recent book is "Money-Driven Medicine: The Real Reason Healthcare Costs So Much." She was recently named a fellow at The Century Foundation.
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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