Robbing Cancer Patients Of Hope

On Dec. 13, a trio of bipartisan U.S. congressmen penned a letter calling for an investigation into the Food and Drug Administration's handling recently of a drug that was being considered for terminal prostate cancer patients.

The letter, addressed to John Dingell, D-Mich., chair 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. Additionally, I am a member of several advocacy groups that have recently stepped up our efforts in response to what can only be considered a vicious assault by the FDA on innovative therapies for Americans who have run out of options in their fight against cancer. The congressmen's letter can be read at www.arighttolive.com.

Prostate cancer kills 30,000 Americans every year, many of whom valiantly served their country. Pathetically, in the last 45 years just one drug has been approved by the FDA for the treatment of these terminal patients and that is a chemotherapy that is 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.

In March, an FDA advisory panel consisting of outside experts (that the FDA itself does not have) reviewed Provenge for the FDA and overwhelmingly recommended approval of Provenge. What followed appeared to border on the bizarre. Two of the 17 panel members who had been placed on the panel under suspiciously orchestrated circumstances carried out an unprecedented campaign against Provenge, sometimes with factually incorrect data. These two doctors, it turns out, had associations with potential competitors of Provenge.

After the FDA declined to approve Provenge, I watched strong, grown men cry. In private, I wept, remembering family members, veterans of WWII, sturdy men withered by prostate cancer then ravaged by the meager treatments available to them.

I hope people will read this poignant letter from these Congressmen to understand the utter lack of compassion and accountability on the part of the FDA when it comes to considering therapies for end stage disease. And I hope people are moved to take action and contact their congressional representative to support hearings in this matter.