Chuck 's letter - Provenge

[Guest guest]

Hello group, I wanted to post Chuck 's article on

Provenge if it hasn't been already. I'm surprised there hasn't

been more discussion on this topic.

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Scrutinize FDA on cancer drug

By CHUCK BENNETT

Posted: Dec. 21, 2007

On Dec. 13, a trio of bipartisan U.S. congressmen penned a letter

calling for an investigation into the Food and Drug Administration's

recent handling of a drug that was being considered for terminal

prostate cancer patients. The letter, addressed to Rep. Dingell

(D-Mich.), chairman of the Committee on Energy and Commerce, which

oversees health-related matters, raises serious questions concerning

unethical behavior at the FDA and should infuriate every American.

I am a physician who often treats end-stage cancer patients. I am

also a member of several advocacy groups that have recently stepped

up efforts in response to what can only be considered an assault by

the FDA on innovative therapies for Americans who have run out of

options in their fight against cancer.

The congressmen include senior members, including the former chair

of the House Committee on Veteran Affairs. (To read the letter, go

to www.arighttolive.com)

Prostate cancer kills 30,000 Americans every year, many of whom

valiantly served their country. Pathetically, in the past 45 years,

just one drug has been approved by the FDA for the treatment of

these terminal patients, and that is a chemotherapy so marginally

effective and wrought with devastating side effects (sometimes

lethal) that most men either don't want it or refuse it altogether.

Then along came Provenge, an immunotherapy to treat prostate cancer

that has demonstrated safety and efficacy in all of six different

studies and has virtually no side effects.

On March 29, an FDA advisory panel consisting of outside experts

(that the FDA itself does not have) reviewed Provenge for the agency

and overwhelmingly recommended approval. What followed appeared to

border on the bizarre.

Two of the 17 members who had been placed on the panel under what I

believe were suspiciously orchestrated circumstances carried out an

unheard of public and visceral campaign against Provenge. The two

doctors, it turns out, had potential conflicts of interest.

The congressmen allege one panel member, Scher, who led the

public opposition to Provenge, was an executive/senior adviser to a

potential competitor of Provenge (Novacea Inc.) as well as a large

venture capital fund (Proquest Investments) heavily invested in

Novacea.

It is clear from deals Novacea and Proquest Investments were

involved in shortly after Provenge was delayed that Scher and his

associates benefited millions of dollars. Nor were these conflicts

listed on Scher's FDA conflict of interest waiver. This is just one

of the many egregious irregularities that culminated in the FDA

failing to approve Provenge.

If this is graft, it is not garden variety by any means; tens of

thousands of American men are suffering and dying.

After the FDA declined to approve Provenge, I watched strong, grown

men cry. In private, I wept, remembering family members, veterans of

World War II, sturdy men withered by prostate cancer, then ravaged

by the meager treatments available to them.

I hope people will read the poignant letter from the congressmen to

understand the utter lack of compassion, objectivity and

accountability on the part of the FDA when it comes to considering

therapies for end-stage disease. After reading the letter, I hope

people are moved to take action and that they contact their

congressional representative to support hearings on this matter.

Physician Chuck of Fond du Lac is a retired Navy commander

and a member of the advocacy group A Right To Live.