F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

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is an article about the decision of the FDA to approve an experimental Alzheimer drug, Aducanumab, for use despite opposition from the scientific community. It was published by the New York Times on June 7th, 2021, the day of the decision by the FDA. It was authored by Pam Belluck and Rebecca Robbins. It raises the over-arching question of whether patient need or scientific rigor should determine the approval of experimental medicies [FxB] .

Details [edit]

Grantedapproval . The FDA granted approval for the drug to be used but is requiring Biogen, the company producing it, to conduct a new clinical trial.

Significantdoubts . The F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. [Ix4]

Patientadvocacygroupshadlobbiedvigorouslyforapproval . There is strong support from those personally affected by Alzheimer’s for the drug’s approval because there are no other promising medications for one diagnosed with Alzheimer’s at this time. The last time an Alzheimer’s drug received approval from the FDA was in 2003.

Expressedskepticism…forapost-markettrial The FDA ruled that Biogen, the company behind the drug, must complete a Phase 4 trial even though the drug has already received approval. Post-market trials are incredibly difficult to perform and unlikely to suceed, however, as patients who can get the drug from a doctor are reluctant to take the chance of receiving a placebo in the trial. [Ix4]

Cruxofthecontroversy The heart of the issue is that two Phase 3 trials for the drug produced results that contradicted each other. One showed the drug had benefit, the other showed that it had none.

Reference [edit]

Belluck, Pam, and Rebecca Robbins. 2021. “F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate over Whether It Works.” The New York Times , June 7, 2021, sec. Health. https://www.nytimes.com/2021/06/07/health/aduhelm-fda-alzheimers-drug.html .