Where Cancer Progress Is Rare, One Man Says No

[Guest guest]

Long, but interesting article in the New York Times about the FDA's approval

process of cancer drugs. (andy)

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September 16, 2009

Forty Years' War

Where Cancer Progress Is Rare, One Man Says No

By GARDINER HARRIS

Politicians and researchers have predicted for nearly four decades that a cure

for cancer is near, but cancer death rates have hardly budged and most new

cancer drugs cost a fortune while giving patients few, if any, added weeks of

life. For this collective failure, the man atop the nation's regulatory agency

for new cancer drugs increasingly - and supporters say unfairly - gets the

blame: Dr. Pazdur.

Patient advocates have called Dr. Pazdur, director of the Food and Drug

Administration's cancer drug office, a murderer, conservative pundits have

vilified him as an obstructionist bureaucrat, and guards are now posted at the

agency's public cancer advisory meetings to protect him and other committee

members.

" The industry is not producing that many good drugs, so now they're looking for

scapegoats in Rick Pazdur and the F.D.A., " said Ira S. Loss, who follows the

drug industry for Washington Analysis, a service for investors.

In 10 years at the Food and Drug Administration, Dr. Pazdur, 57, has helped to

loosen approval standards for cancer medicines and made it easier for dying

patients to get experimental drugs. But he demands that drug makers prove with

near certainty that their products are beneficial, a requirement that he

repeated at a public advisory hearing on Sept. 1 in the slow, loud tones of

someone disciplining a dog. After he spoke, the committee of experts voted to

reject both drugs.

Critics say that Dr. Pazdur's resolve has cost thousands of lives and set back

the pace of discoveries.

For full story, see

http://www.nytimes.com/2009/09/16/health/policy/16cancer.html?_r=1 & th= & emc=th & pa\

gewanted=print

or http://tiny.cc/uXxu5

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