On the front page of today's NYT (http://www.nytimes.com/2007/09/28/health/policy/28fda.html?ex=1348718400&en=30b7a25ac3835517&ei=5124&partner=permalink&exprod=permalink)
is an article describing a report to be released today by teh inspector general of the Department of Health and Human Service that concludes that FDA oversight of clinical trials (mostly for drugs seeking approval by the agency from the industry) is sorely lacking.
In it, Rosa DeLauro (D-CT) opines that the agency puts industry interests ahead of public health. Oh, really?
Read the posts below and you might be of the same impression. Some of the study designs the FDA approves for testing of agents are just unconscionable. These studies have little or no value for the public health, science, or patients. They serve only as coffer-fillers for the industry. Sadly, they often serve as coffin-fillers when things sometimes go terribly awry. Think Trovan. Rezulin. Propulsid. Vioxx.
The medical community, as consumers of these "data" and the resulting products, has an obligation to its patients which extends beyond those which we see in our offices. We should stop tolerating shenanigans in clinical trials, "me-too" drugs, and corporate profiteering at the expense of patient safety.
This is discussion forum for physicians, researchers, and other healthcare professionals interested in the epistemology of medical knowledge, the limitations of the evidence, how clinical trials evidence is generated, disseminated, and incorporated into clinical practice, how the evidence should optimally be incorporated into practice, and what the value of the evidence is to science, individual patients, and society.
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Good post.......
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