Is Alzheimers drug Aducanumab a breakthrough or a boondoggle?

Patients and their families may see hope in the news that the Food and Drug Administration has approved a drug to slow the pace of Alzheimer’s disease. Aducanumab is the first medicine authorized to treat what might be an underlying cause of the disease: amyloid beta clumps that accumulate in the brain. Yet the evidence from clinical trials that this drug reduces Alzheimer’s is incomplete; it may be only minimally effective, if it works at all. The FDA’s own expert panel strongly objected to the drug’s approval.

All of which makes the FDA’s announcement both perplexing and wrong. It threatens to mislead millions of Alzheimer’s patients. At the same time, because Biogen plans to price the drug at $56,000 a year for the average patient, it also stands to cost Medicare and other insurers a bundle. This underlines the need for two kinds of reform. First, the FDA needs to rethink its processes for approving drugs. Second, the rules controlling how Medicare chooses and pays for medicines need a thorough overhaul.

The FDA has failed to fully explain why it overruled the almost unanimous advice of its advisory panel on aducanumab. The agency didn’t deny that the clinical-trial evidence was poor. It simply ignored that problem and used different reasoning to grant the drug “accelerated approval.”…In fact, it’s a more limited endorsement than ordinary approval, indicating that the drug has not proven a “real effect on how a patient survives, feels or functions,” in the FDA’s words, but nevertheless acts on an underlying disease process in a way that might predict such a benefit…

Despite that, Biogen will sell aducanumab — under the brand name Aduhelm — at an exorbitant cost…The nonprofit Institute for Clinical and Economic Review has said that even if the drug works as well as Biogen suggests it can, it would be cost-effective at a price of $2,600 to $8,300 a year…

But, hey…Congress apparently thinks Biogen should get every penny they can squeeze from us, our tax dollars and anything else they lay their greedy hands on.

One thought on “Is Alzheimers drug Aducanumab a breakthrough or a boondoggle?

  1. p/s says:

    Three experts resign as FDA advisors over approval of Alzheimer’s drug
    One former advisor accused the FDA of presenting “slanted” questions to committee.
    https://arstechnica.com/science/2021/06/three-experts-resign-as-fda-advisors-over-approval-of-alzheimers-drug/
    The advisory committee reviewed the data behind Aduhelm last November and voted overwhelmingly against approval. Of the 11 advisors on the committee, 10 voted “no” on the question of whether Biogen had collected enough evidence to indicate that the drug is effective. The remaining advisor voted “uncertain.”
    Nevertheless, the FDA approved the drug on Monday. Though the regulator acknowledged that there are “residual uncertainties regarding [the] clinical benefit” of Aduhelm, the FDA said it decided to lower the requirements for approval after the advisory committee voted. Instead of basing the approval on the drug’s demonstrated efficacy, the agency relied on a “surrogate endpoint.” In this case, the surrogate is the ability of the drug to reduce amyloid beta plaques in the brains of some Alzheimer’s patients.
    “In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.” https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

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