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After two drug trials were stopped because they showed little prospect of helping Alzheimer’s patients, the FDA worked behind the scenes to salvage the drug, eventually approving it over the strong objections of its own independent expert advisory panel. Ten of eleven panel members had concluded there was insufficient evidence to show that the drug worked. The eleventh member was “uncertain.” Three panel members resigned in protest over the FDA’s decision. One of them, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, called the regulator’s decision “probably the worst ...more
When McKinsey Comes to Town: The Hidden Influence of the World's Most Powerful Consulting Firm
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