Comments on: The cruel economics of cancer http://blog.mesorc.com/2008/05/27/the-cruel-economics-of-cancer/ Insight and Information for Families Affected by Mesothelioma Fri, 5 Dec 2008 10:50:08 +0000 http://wordpress.org/?v=2.6 By: Steve Walker http://blog.mesorc.com/2008/05/27/the-cruel-economics-of-cancer/#comment-795 Steve Walker Tue, 27 May 2008 12:05:45 +0000 http://blog.mesorc.com/2008/05/27/the-cruel-economics-of-cancer/#comment-795 An excellent summary of the problem. In fact, Dr. Pazdur's policies have been highly reactionary and inflexible. Instead of seeking modernization of the agency's cancer drug development policies and approval criteria to better fit the emerging science, he has instead regressed into rigid application of arcane statistical rules and metrics that don't fit the new knowledge of disease biology and drug invention. Under Dr. Pazdur, FDA's handling of cancer drugs has become a profound barrier to progress against cancer. Dr. Pazdur has his supporters. Most of them are people whose continued financial and professional status in our clinical trials system depend on maintaining the failing status quo. However, the more direct and obvious problem is the failure of FDA's leadership to supervise the sharp decline of competence and progress in FDA's handling of cancer drugs. That abdication of responsibility continues today, evidenced by Dr. Pazdur's continuing policies, and some would argue, his continued employment. He is very much a hands-on manager, directly responsible for the decisions to delay and deny the approvals of numerous safe and effective cancer drugs over the last 7 years. His policies and approval decisions are not required by law or regulation. They are quite simply, and by his own admission, his policies. An example is his decision to create and enforce a policy we call his "Decelerated Approval Initiative." Dr. Pazdur's Decelerated Approval Initiative has effectively eliminated the Congressionally-created Accelerated Approval pathway (a major part of the success in treating HIV/AIDS) as a viable approval mechansim for cancer drugs. He announced his cancer-drug "slow down" policies in the spring of 2003 with ensuing devastating effect. The most compellingly effective new cancer drugs now take years longer to reach patients who die waiting for them, victims of progressive terminal diseases that do not stop progressing while the FDA dithers. The result has been hundreds of thousands of unnecessarily premature deaths from cancer. No less an authority than David Kessler, the former Commisisoner of the FDA, who established Accelerated Approval at the FDA in 1997 at the direction of Congress, is asking why FDA leadership allowed the erosion of this critically-needed and highly successful approval authority. Legislation directed at fixing the serious (and deadly) problems with FDA's handling of new drugs intended to treat serious and life-threatening diseases like cancer, called the Access Act, was re-introduced in Congress last week with bipartisan support. The bill contains provisions that firmly re-establishes Accelerated Approval, and would provide patients with serious and life-threatening diseases the same access to progress that now reaches HIV/AIDs patients by increases the role of those patients and their doctors in making health care decisions when all FDA approved options have been exhausted. The bill also requires modernization of FDA's drug development and approval science, and requires an Institute of Medicine study to begin the process of modernization. The Access Act, when passed, will be a crucial step toward bringing the FDA into alignment with accelerating progress against cancer and other serious diseases. If it does not pass, FDA will continue to function as a barrier to progress. Agency leadership has for years turned a deaf ear to patients suffering and dying from cancer and other serious conditions, preferring the counsel of those who unconditionally agree with the culture of scientific and regulatory stagnation that exists at FDA. The result is an agency focused on defending the failing status quo as a much higher priority than keeping up with rapidly advancing fundamental science that offers boundless potential for making progress against the diseases that kill us. The FDA has a long track record of being incapable of internal change. Change comes to the FDA only when imposed from the outside by Congress, the courts or overwhelming public pressure, and it usually takes a combination of all three before the FDA manages to get out of its own way and begin a process of real change. Support the Access Act. It could save your life. Steve Walker Abigail Alliance An excellent summary of the problem. In fact, Dr. Pazdur’s policies have been highly reactionary and inflexible. Instead of seeking modernization of the agency’s cancer drug development policies and approval criteria to better fit the emerging science, he has instead regressed into rigid application of arcane statistical rules and metrics that don’t fit the new knowledge of disease biology and drug invention. Under Dr. Pazdur, FDA’s handling of cancer drugs has become a profound barrier to progress against cancer.

Dr. Pazdur has his supporters. Most of them are people whose continued financial and professional status in our clinical trials system depend on maintaining the failing status quo. However, the more direct and obvious problem is the failure of FDA’s leadership to supervise the sharp decline of competence and progress in FDA’s handling of cancer drugs. That abdication of responsibility continues today, evidenced by Dr. Pazdur’s continuing policies, and some would argue, his continued employment. He is very much a hands-on manager, directly responsible for the decisions to delay and deny the approvals of numerous safe and effective cancer drugs over the last 7 years. His policies and approval decisions are not required by law or regulation. They are quite simply, and by his own admission, his policies. An example is his decision to create and enforce a policy we call his “Decelerated Approval Initiative.” Dr. Pazdur’s Decelerated Approval Initiative has effectively eliminated the Congressionally-created Accelerated Approval pathway (a major part of the success in treating HIV/AIDS) as a viable approval mechansim for cancer drugs. He announced his cancer-drug “slow down” policies in the spring of 2003 with ensuing devastating effect. The most compellingly effective new cancer drugs now take years longer to reach patients who die waiting for them, victims of progressive terminal diseases that do not stop progressing while the FDA dithers. The result has been hundreds of thousands of unnecessarily premature deaths from cancer. No less an authority than David Kessler, the former Commisisoner of the FDA, who established Accelerated Approval at the FDA in 1997 at the direction of Congress, is asking why FDA leadership allowed the erosion of this critically-needed and highly successful approval authority.

Legislation directed at fixing the serious (and deadly) problems with FDA’s handling of new drugs intended to treat serious and life-threatening diseases like cancer, called the Access Act, was re-introduced in Congress last week with bipartisan support. The bill contains provisions that firmly re-establishes Accelerated Approval, and would provide patients with serious and life-threatening diseases the same access to progress that now reaches HIV/AIDs patients by increases the role of those patients and their doctors in making health care decisions when all FDA approved options have been exhausted. The bill also requires modernization of FDA’s drug development and approval science, and requires an Institute of Medicine study to begin the process of modernization.

The Access Act, when passed, will be a crucial step toward bringing the FDA into alignment with accelerating progress against cancer and other serious diseases. If it does not pass, FDA will continue to function as a barrier to progress. Agency leadership has for years turned a deaf ear to patients suffering and dying from cancer and other serious conditions, preferring the counsel of those who unconditionally agree with the culture of scientific and regulatory stagnation that exists at FDA. The result is an agency focused on defending the failing status quo as a much higher priority than keeping up with rapidly advancing fundamental science that offers boundless potential for making progress against the diseases that kill us.

The FDA has a long track record of being incapable of internal change. Change comes to the FDA only when imposed from the outside by Congress, the courts or overwhelming public pressure, and it usually takes a combination of all three before the FDA manages to get out of its own way and begin a process of real change.

Support the Access Act. It could save your life.

Steve Walker
Abigail Alliance

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