The Trends Journal has published several articles recently dealing with the U.S. Food and Drug Administration’s approval of an Alzheimer’s drug, aducanumab, produced by Biogen and sold as Aduhelm, the first new drug for Alzheimer’s disease in almost twenty years.
Those articles, such as 15 June’s “ALZHEIMER’S DRUG? FORGET ABOUT IT” and another in this issue, FDA APPROVES NON-EVIDENCE BASED DRUG, deal with the dissent within the FDA over the drug’s approval, which the agency granted apparently without the usual clinical proof of the drug’s effectiveness. FDA statisticians raised objections to the lowering of standards, and three members of a select FDA advisory panel signaled their displeasure by tendering their resignations; one of them called the agency’s action “probably the worst drug approval decision in recent U.S. history.” That panel had voted unanimously to oppose approval of the drug.
While essentially ignored by the U.S. media, and certainly not a “conspiracy theory,” the Financial Times reported on 23 June that the controversy has not ended with the drug’s approval and the resignation of the panel members.
Critics both within and outside the regulatory agency are calling for the ouster of Janet Woodcock, currently acting commissioner of the FDA and considered a prime candidate to be its permanent commissioner.
Michael Carome, of Public Citizen, a consumer advocacy group, is among those calling for Woodcock’s removal, on the grounds that she has allowed the agency to develop uncomfortably close and ethically questionable ties to Big Pharma, resulting in the FDA putting the interests of drug makers and their shareholders above those of patients and public health. Carome has also called for the ouster of the director of the Center for Drug Evaluation and the director of the FDA’s Office of Neuroscience.
The FT article chronicles similar controversies that the FDA has faced. In 2015 the FDA approved a version of Viagra for women that claimed to be a libido enhancer, despite fears that side effects outweighed its benefits. In 2016 the regulators approved a muscular dystrophy drug in a decision that critics say was based, like the decision to approve the Alzheimer’s drug, on “weak scientific evidence.”
As evidence of the “too close” relationship between the agency and the industry, critics point to a joint briefing document, released by the FDA and Biogen as part of the application for approval of the Alzheimer’s drug, which critics call “a curious move.”
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The FDA claims collaboration with the drug industry is necessary and helpful. But the critics believe that such closeness constitutes a breach of an ethical barrier between the regulators and those they are supposed to regulate.
Need proof? As we had noted, the former commissioner, Scott Gottlieb is now on the board of directors of Pfizer, the Big Pharma drug dealer that made nearly $1 billion in vaccine profits in the first quarter of this year.