Post by Bozur on Dec 23, 2007 18:32:53 GMT -5
The FDA's handling of proposed cancer drug defies compassion
fdlreporter.com — On Dec. 13, a trio of bipartisan Congressmen penned a letter calling for an investigation into the FDA's handling recently of a drug that was denied approval for terminal prostate cancer patients. The letter raises serious questions concerning unethical behavior at the FDA and should infuriate every American.
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Posted December 21, 2007
Commentary: FDA's handling of proposed cancer drug defies compassion, accountability
On Dec. 13, a trio of bipartisan Congressmen penned a letter calling for an investigation into the FDA's handling recently of a drug that was denied approval for terminal prostate cancer patients. The letter raises serious questions concerning unethical behavior at the FDA and should infuriate every American.
Their letter can be read at www.arighttolive.com.
I am a member of several advocacy groups that have recently stepped up our 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.
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.
On March 29, 2007, an advisory panel reviewed Provenge for the FDA and overwhelmingly recommended approval of its use. What followed appeared to border on the bizarre: Two of the 17 panel members (who had been placed on it under suspiciously orchestrated circumstances) carried out an unheard-of public and visceral campaign against Provenge, sometimes with factually incorrect data.
These two doctors, it turns out, had numerous conflicts of interest that were not listed on their conflict-of-interest waiver application. As a result of this, and other irregularities, the FDA failed to approve Provenge. Any notion that the FDA cannot staff these panels without significant conflicts of interest will, at best, further erode the public's confidence in the FDA and at worst, lead to situations such as this.
Provenge is an immunotherapy and not chemotherapy. Both panel members are experienced with chemotherapy but had no experience with immunotherapy. Why were the other experts ignored?
This is the first time a treatment for end-stage disease was recommended by an FDA expert advisory committee but rejected by the FDA. 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 WWII, sturdy men withered by prostate cancer then ravaged by the meager treatments available to them; remembering my wife's family devastated by cancer and the countless number of patients I have come to know and care for. We hope people will read this poignant letter from these 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. We hope people are moved to take action and contact their congressional representative to support hearings in this matter.
The writer, Chuck Bennett, M.D., LCDR, USN (Retired) is an Advocate for A Right To Live and resides in Fond du Lac.
Chuck Bennett, M.D., LCDR, USN (Retired)
Advocate, A Right To Live
Fond du Lac
www.fdlreporter.com/
fdlreporter.com — On Dec. 13, a trio of bipartisan Congressmen penned a letter calling for an investigation into the FDA's handling recently of a drug that was denied approval for terminal prostate cancer patients. The letter raises serious questions concerning unethical behavior at the FDA and should infuriate every American.
-------------------
Posted December 21, 2007
Commentary: FDA's handling of proposed cancer drug defies compassion, accountability
On Dec. 13, a trio of bipartisan Congressmen penned a letter calling for an investigation into the FDA's handling recently of a drug that was denied approval for terminal prostate cancer patients. The letter raises serious questions concerning unethical behavior at the FDA and should infuriate every American.
Their letter can be read at www.arighttolive.com.
I am a member of several advocacy groups that have recently stepped up our 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.
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.
On March 29, 2007, an advisory panel reviewed Provenge for the FDA and overwhelmingly recommended approval of its use. What followed appeared to border on the bizarre: Two of the 17 panel members (who had been placed on it under suspiciously orchestrated circumstances) carried out an unheard-of public and visceral campaign against Provenge, sometimes with factually incorrect data.
These two doctors, it turns out, had numerous conflicts of interest that were not listed on their conflict-of-interest waiver application. As a result of this, and other irregularities, the FDA failed to approve Provenge. Any notion that the FDA cannot staff these panels without significant conflicts of interest will, at best, further erode the public's confidence in the FDA and at worst, lead to situations such as this.
Provenge is an immunotherapy and not chemotherapy. Both panel members are experienced with chemotherapy but had no experience with immunotherapy. Why were the other experts ignored?
This is the first time a treatment for end-stage disease was recommended by an FDA expert advisory committee but rejected by the FDA. 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 WWII, sturdy men withered by prostate cancer then ravaged by the meager treatments available to them; remembering my wife's family devastated by cancer and the countless number of patients I have come to know and care for. We hope people will read this poignant letter from these 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. We hope people are moved to take action and contact their congressional representative to support hearings in this matter.
The writer, Chuck Bennett, M.D., LCDR, USN (Retired) is an Advocate for A Right To Live and resides in Fond du Lac.
Chuck Bennett, M.D., LCDR, USN (Retired)
Advocate, A Right To Live
Fond du Lac
www.fdlreporter.com/