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FDA failing to fulfill its mission... says CCC Chairman
The Supreme Court's refusal to review the decision in the Abigail Alliance Case denying access to new therapies for critically ill patients has far reaching implications for the public. Because of it, people whose lives might have been saved by these new treatments will die.
The FDA is failing in key areas of its mission and the American People are suffering the consequences. In a November 2007 report entitled FDA Science and Mission at Risk, prepared for the FDA by its own subcommittee on Science and Technology, it states:
1.2.1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
1.2.2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
1.2.3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
In the context of the report, it further states that "the lack of new science capability/ capacity places the FDA mission at risk for those many products at the leading edge of innovation."
Rather than consent to modify its procedures to allow critically ill patients to access new treatments, the FDA fought to deny them this right. It contended that allowing access would impede clinical trials. This access is permitted in Germany and there have been no such problems resulting from it. The FDA has won the legal battle, but it has lost the moral one.
It has long been thought that the FDA is not open to new therapies for the treatment of cancer. The bureaucrats at the FDA are afraid to make decisions dealing with novel therapies. They don't like dealing with small biotechs and independent researchers and they prefer to deal with large pharmaceutical companies requesting minor improvements of existing therapies.
The fact that large pharmaceutical companies under federal law help fund the FDA and that some of the FDA's employees after retirement go to work for those same companies creates an inherent bias in the system. It has been claimed that some of the employees of the FDA act to further their own self interests and not that of the sick and dying patients.
In order to avoid the risk of being criticized for a wrong decision they keep asking for more and more testing thereby keeping important new therapies from reaching patients who desperately need them. The additional testing escalates the cost of the clinical trials.
The clinical trials required by the FDA now take an average of ten years and cost upwards of eight hundred million dollars for completion. Many of the drugs are not approved and the cost of those trials tends to increase the cost of the products that do make it to market. The enormous cost of the trials is one of the major causes of the high cost of medical treatment in the United States. That cost is now of such a magnitude that it is adversely affecting our economy.
The FDA should encourage the development of new therapies and not subject them to long and unfair trials. And, because of the excessive delays, it is important that patients be allowed access to these new therapies after their safety has been determined and before the final approvals. It is not enough to do research that finds cures for cancer. To benefit people, these cures must be made available.
Dr. Henry I. Miller is a Research Fellow at the Hoover Institution, a former FDA senior official and the founding director of the FDA's office for Biotechnology. In his book To America's Health, A Proposal to Reform the Food and Drug Administration, he stated: "Three things are clear. Reform of drug regulation is necessary, it must be fundamental in nature, and it must come from outside the agency via new legislation."
There is a need for improvement at the FDA. We need an agency that will work to help bring forward new and better treatments. We need an agency that is sympathetic to the needs of patients confronting death-causing illness. If the agency cannot or will not reform itself voluntarily, then I believe that the Congress and the President must make it do so.
Charles A. Reinwald, Chairman
Cancer Cure Coalition, Inc.
800 Village Square Crossing, Suite 222
Palm Beach Gardens, FL 33410
(561) 747-2174
E-Mail: cancercurecoal@aol.com / chalres01234@aol.com
Web Site: www.cancercurecoaltion.org
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