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Alzheimer's drug approval: Advocacy group calls for FDA resignations

Published on 21/06/21 at 08:35am

Public Citizen, the US consumer advocacy group, has called for the resignation of three top FDA officials following the approval of the Biogen’s controversial new Alzheimer’s drug, Aduhelm.

The approval has been divisive, as many experts believe the drug does not actually work, and several FDA panel members have quit already.

Conversely, many patients and care givers are happy to be offered some hope, as it’s the first new Alzheimer’s rug to be approved in two decades.

Public Citizen is asking Xavier Becerra, the new head of the Department of Health and Human Services, to request the resignations of Janet Woodcock, acting FDA commissioner, Patrizia Cavazzoni, Director of the FDA's Centre for Drug Evaluation and Research, and Billy Dunn, Director of the agency's neuroscience office.

As reported in BioPharma Dive, Director of Public Citizen’s health research group, Michael Carome, wrote in a June 16 letter to Becerra: "The FDA's decision to approve aducanumab for anyone with Alzheimer's disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency's standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.

"The primary beneficiaries of the agency's action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the company's exorbitantly priced but ineffective drug."

Carome told BioPharma Dive that Public Citizen has never before made "such a formal request urging the resignations or removal of FDA officials over a specific action," nor has the group objected so strongly to an FDA drug approval decision.

Critique has been widespread, Ron Wyden, the Democratic senator from Oregon wrote on twitter that it’s "unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective."

The FDA said they approved the drug after deciding that it could manage some symptoms of Alzheimer's, including anxiety and insomnia, saying the approval is “based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients”.

Aducanumab targets the underlying cause of Alzheimer's, the most common form of dementia, rather than its symptoms.

The WHO estimates that 50 million people around the world suffer with dementia, with Alzheimer’s contributing up to 70% of those cases. 10 million new cases are added every year.

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