NEW YORK, July 6 (Xinhua) -- The U.S. Food and Drug
Administration (FDA)'s decision to delay approving an experimental therapy to
treat prostate cancer has enraged seriously ill patients and triggered a bitter
debate in the country, The Washington Post reported Friday.
The first-of-its-kind therapy, called Provenge, is a
"vaccine" designed to extend the lives of patients with advanced prostate cancer
by stimulating their immune systems.
A panel of experts recommended in March that the FDA
approve Provenge. But in May, the agency instead asked for more evidence that
the vaccine works after specialists, including Howard I. Scher of the Memorial
Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan,
questioned its effectiveness.
Scher and Hussain told the FDA that Dendreon Corp.,
the small Seattle biotech company that developed Provenge, submitted a study to
win approval for the drug that was so small that the apparent benefit it showed
could have been the result of chance.
The two experts then began receiving anonymous
e-mails, phone calls and letters attacking and sometimes threatening them.
Patients and advocacy groups staged a Capitol Hill
rally on June 4, and demanded and got a meeting with FDA Commissioner Andrew C.
von Eschenbach the same day. They began lobbying to amend FDA legislation moving
through Congress to allow easier access to experimental treatments. But the FDA
insisted that additional scientific data is required.
The Provenge controversy comes amid revelations that
a widely used diabetes drug, Avandia, may increase the risk of heart attacks.
That triggered a similarly intense debate, including angry criticism of
cardiologist Steven Nissen of the Cleveland Clinic, who sounded the alarm about
the drug.
People were divided over the issue, with some saying
that FDA needs to be more vigilant while others believe the process is too long
a wait.