Good News, But Prostate Cancer Patients Still Waiting

Good News, But Prostate Cancer Patients Still Waiting

FDA Should Have Approved Provenge Years Ago
April 21, 2009

Washington, D.C., April 21, 2009—Sunday’s meeting of the
American Association of Cancer Research saw new hope for prostate cancer
patients, as researchers announced very favorable results for the drug
Provenge. This announcement, however, only highlights the shortcomings of the
Food and Drug Administration, which has refused to approve the drug, despite
previous studies indicating its safety and effectiveness.

“This is good news, but there was sufficient information
available for FDA to have approved Provenge nearly two years ago,” said
Competitive Enterprise Institute Senior Fellow Gregory Conko. “The agency
forced drug maker Dendreon to spend the last two years performing additional
tests, when its own independent advisory committee voted 17 to 0 that Provenge
was safe and 13 to 4 that it was effective enough for approval. This has
needlessly forced tens of thousands of prostate cancer sufferers to miss what
might have been their only chance at survival.”

The Competitive Enterprise
Institute
and the Bureaucrash Activist
Network
, in cooperation with the Abigail
Alliance
and Accelerate Progress,
have worked to raise awareness about the slow pace of the FDA approval process
and need to approve Provenge in particular. In September of 2007, the groups
collaborated on a
protest and video
in which prostate cancer patients told their stories. In
all the time since then, the FDA has refused to move forward.

“The only currently approved drug for the treatment of
end-stage prostate cancer, Taxotere, is less effective and is so toxic it kills
roughly 300 patients each year,” said Conko. “And, while the new test results
confirm what was already shown in earlier testing, it will still be at least
several months more before the FDA will make a decision on approval,
during which time prostate cancer patients will continue to suffer, and many of
them will die waiting for the agency to act.” 

CEI is a non-profit, non-partisan
public policy group dedicated to the principles of free enterprise and limited
government.  For more information about
CEI, please visit our website at www.cei.org.