A while back I linked to a draft of the Institute of Medicine report on drug safety. Dr. Bruce Psaty and Nurse Sheila Burke take care of us as citizens with a good summary of the issues, free even to the common rabble, in today's NEJM. Their bottom line:
[T]he IOM committee identified a number of serious problems, including a lack of clear regulatory authority, chronic underfunding, organizational difficulties, and a scarcity of post-approval data. Contributing to an urgent need for cultural change in the FDA are a suboptimal work environment, a lack of consistency among CDER [Center for Drug Evaluation Research] review divisions, polarization between the offices responsible for the pre-marketing review and post-marketing surveillance, CDER management's disregard and disrespect for scientific disagreement, and politicization and a lack of stability in the office of the FDA commissioner.
Subtext: The FDA works for drug companies, not the public. This is nothing new -- it is a well-known pattern in the U.S. for regulatory agencies to be captured by the industries they regulate. And it will continue to happen so long as elected officials -- in the Congress and the White House -- are working for the drug companies, not for you. There's nothing libertarian, or conservative, about that. They're just screwing you.
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