In a new podcast, Sirota talks with Dr. Aaron Kesselheim, the Harvard researcher who last month touched off national headlines when he resigned from a panel that advises the Food and Drug Administration on drug approvals.
Kesselheim quit because the agency approved a pharmaceutical company's unproven Alzheimer's treatment, even though the panel of overseers was nearly unanimous in finding that the therapy had not displayed compelling evidence that it worked.
In a co-authored New York Times op-ed, Kesselheim warned that "in recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the FDA has progressively lowered its standards of effectiveness and safety required for drug approvals."
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So, in this case there was a "high level of coordination" between drug manufacturer, Biogen, and the FDA, "higher than usual" and as a result, the decision-making process that was used to decide whether to release this drug was flawed. Dr. Kesselheim resigned from the FDA advisory committee to shine a spotlight on this flawed process. I wonder what he meant by "higher level of coordination"?