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FDA Cancer Czar Stirs Debate On Agency's Role
Keywords:
Tags: Pharmaceutical, Healthcare,
Questions raised about Dr Pazdur's decisions at FDA for anemia drugs made by Amgen and Johnson and Johnson. Dr Pazdur is head of the FDA office that regulates oncology drugs, all cancer drugs. Dr Pazdur's review process and decision shows how reviewers are human and their own experience helps determine what they see prominently. His experience with his father who suffered severely from the side effects of steroid drugs would make him aware of the the other effects of drugs. He is an oncologist, his wife is an oncology nurse, and some relatives have died of cancer, so he has lived with cancer patients. It appears from close associates that he like open communication and hears all sides but makes the final decision himself. He had an experience with a drug for lung cancer Iressa made by Astra -Zeneca, which the FDA approved based on testimonials, but not enough statistical evidence, which later failed and approval had to be withdrawn. This may have made him more inclined to look for strong results and statistical evidence before concluding on the safety and effectivenes of a drug. An approach evident with Amgen's anemia drug. It also appears that the FDA is not clear on whether the drug's effectiveness is to be judged by what result, is it whether it prolongs life only that counts, or whether the effectiveness in relieving significantly the symptoms of a patient even if life is not prolonged. There is the controversy surrounding the FDA's rejection of a drug by Genta Inc Genasense that relieved patient symptoms for leukemia but did not prolong their life. These and other questions continue to give sleepless nights to people at the FDA and outside as the drug review process faces difficult balancing act between what to give importance and what direction to take with a drug in patient's interests. In Dr Pazdur's case this is made more difficult as he thinks every day of his father who died in 1979 and suffered from the side effects of steroid drugs, went blind when Dr Pazdur was only a teen, and had pulmonary fibrosis and diabetes. He is described by doctors who trained under him as gentle but did meet a patient's eyes and tell him that he had to come to terms with his disease.
FDA's approach to approving drugs of pharmaceutical companies and weighing the risks and benefits.
07/01/2005
The questions of safety balanced by the need to let patients have access to drugs that would help them. The processes the FDA uses to arrive at proper decisions.
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