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In our 15 June 2021 article, “ALZHEIMER’S DRUG? FORGET ABOUT IT,” Trends Journal reported on the dissent voiced over the FDA’s approval of Biogen’s new Alzheimer’s drug, the first new Alzheimer’s drug in almost 20 years, aducanumab, to be sold as Aduhelm.
The dissent focused on the lack of clinical evidence of the drug’s benefit. Critics of the FDA decision on 7 June to approve the drug say that the agency bypassed the scientific standards it would normally impose on drug makers, and that the result may be billions in government expenditures for a drug that doesn’t work.
The objections were raised mostly by the agency’s statisticians, but three members of the FDA’s Peripheral and Central Nervous System Advisory Committee went beyond dissent, tendering their resignations in protest of the agency’s approval of the drug.
Now a 23 June article in The Wall Street Journal announces that the actual internal memos documenting that dissent have been made public. And they show that the FDA’s decision to ignore what would have been a lack of conclusive clinical evidence as to the drug’s value, as well as to ignore the many voices raised against approval, was influenced by the desperation of Alzheimer’s patients for treatments.
The approval seems to have taken advantage of a sort of loophole in the approval process called “accelerated approval,” described by the WSJ as a type of regulatory clearance that permits a drug to be marketed if it fills an unmet need for a serious disease even when its actual clinical benefit is uncertain.
TRENDPOST: Alzheimer’s patients and their families now have the opportunity to pay dearly for hopes that may prove to be false. Aduhelm will cost some $56,000 a year and the WSJ says analysts project Biogen could eventually surpass $5 billion in yearly sales, while some economists say the multiples will be much higher.