09-27-2021, 08:46 AM
The road to Aduhelm: What one ex-FDA adviser called 'probably the worst drug approval decision in recent US history' for an Alzheimer's treatment
![[Image: 210910142140-dr-aaron-kesselheim-restric...er-169.jpg]](https://cdn.cnn.com/cnnnext/dam/assets/210910142140-dr-aaron-kesselheim-restricted-super-169.jpg)
(CNN)Dr. Aaron Kesselheim had been on an advisory committee for the US Food and Drug Administration for a half-dozen years, but he had never been to a meeting like this one.
The FDA establishes advisory committees to assist the federal agency with one of its most important duties: deciding whether to approve the distribution of new drugs. The stakes of these decisions are enormous. Based on the outcome of the FDA's deliberations, patients may gain access to lifesaving medicines, and manufacturers may reap billions in profits. Kesselheim, a professor at Harvard Medical School, was one of the members of this committee because of his expertise on pharmaceuticals that address diseases of the brain, including Alzheimer's, the irreversible, progressive brain disorder that destroys memory and thinking skills, and eventually causes death. Alzheimer's is the sixth leading cause of death in the United States.
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The FDA establishes advisory committees to assist the federal agency with one of its most important duties: deciding whether to approve the distribution of new drugs. The stakes of these decisions are enormous. Based on the outcome of the FDA's deliberations, patients may gain access to lifesaving medicines, and manufacturers may reap billions in profits. Kesselheim, a professor at Harvard Medical School, was one of the members of this committee because of his expertise on pharmaceuticals that address diseases of the brain, including Alzheimer's, the irreversible, progressive brain disorder that destroys memory and thinking skills, and eventually causes death. Alzheimer's is the sixth leading cause of death in the United States.
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