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.

7 thoughts 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

  2. Update says:

    A leading advocacy and watchdog group is calling for the ouster of three top officials at the Food and Drug Administration—including its acting commissioner—after the regulator issued a highly contentious approval last week of the unproven and now highly priced Alzheimer’s drug Aduhelm (generic name: aducanumab).
    The call for fresh FDA leadership comes atop a chorus of harsh criticism over the decision, which outside researchers and industry experts have called “disgraceful” and “dangerous,” among other things. https://arstechnica.com/science/2021/06/advocacy-org-calls-for-ouster-of-fda-officials-after-alzheimers-drug-approval/
    Letter from Michael Carome, director of Public Citizen’s Health Research Group to Xavier Becerra, secretary of the Department of Health and Human Services https://www.citizen.org/wp-content/uploads/2590.pdf?eType=EmailBlastContent&eId=71e193ec-6879-407a-bea6-e88ea51fdfd5

  3. Boomer says:

    Controversial Alzheimer’s drug could cost US $334B—nearly half of DoD budget https://arstechnica.com/science/2021/06/controversial-alzheimers-drug-could-cost-us-334b-nearly-half-of-dod-budget/
    Concern is mounting over the price of the controversial new Alzheimer’s drug Aduhelm. Advocates, lawmakers, and critics worry in particular about what the drug’s $56,000 per-year list price will do to Medicare. The federal insurance program is available to those age 65 and over, which covers the vast majority of the roughly 6 million adults with Alzheimer’s in the US.
    A new analysis released Monday estimated that if all 5.8 million Medicare-eligible adults with Alzheimer’s began taking Aduhelm, it could cost Medicare $334.5 billion a year.
    That amount significantly exceeds Medicare’s spending on doctor-administered and retail prescription drugs combined, which totaled about $220 billion in 2019.
    See also “Will Biogen’s new Alzheimer’s drug’s burden on Medicare be big, huge, or catastrophic?” https://www.statnews.com/2021/06/28/biogens-alzheimers-drug-medicare-huge-or-catastrophic/

    • p/s says:

      The copays for aducanumab, which may be as much as 20% of the total cost, will be added to the already substantial financial burden many American families face due to Alzheimer’s disease.
      According to a new article in the Hastings Center Report the U.S. Food and Drug Administration’s controversial decision to approve aducanumab for the treatment of Alzheimer’s disease raises at least three major ethical issues that need to be addressed: https://www.eurekalert.org/pub_releases/2021-06/thc-aaa062821.php
      (1) Medicare resources would be unjustly squandered, given the drug’s $56,000 annual price and the 3.1 million older potential American patients needing the drug; (2) physicians will feel ethically compelled to provide the drug to desperate, insistent patients, given FDA approval and in spite of side effects of brain bleeds and brain swelling; (3) and false hopes are generated for patients. Also, clinicians will have to address with patients, uncertainty regarding whether the drug is even beneficial or safe. https://onlinelibrary.wiley.com/doi/abs/10.1002/hast.1264

  4. Fugetaboutit says:

    Expert panel says new $56K Alzheimer’s drug is unproven—and worth $8,400 max https://arstechnica.com/science/2021/07/expert-panel-says-new-56k-alzheimers-drug-is-unproven-and-worth-8400-max/
    Biogen’s top medical officer, Maha Radhakrishnan, M.D., argued that evaluating the med would require “innovative thinking” and a new framework to assess its potential value. https://www.fiercepharma.com/pharma/despite-biogen-s-sharp-rebuke-cost-watchdog-experts-unanimously-refute-aduhelm-s-benefits

  5. Donno says:

    “Ad campaign for controversial Alzheimer’s drug will ‘overly medicalize’ normal age-related memory loss, some experts say” https://www.cnn.com/2021/07/23/health/alzheimers-drug-controversial-campaign-partner/index.html
    “Maker of dubious $56K Alzheimer’s drug offers cognitive test no one can pass : After facing intense criticism, Biogen goes on defense, blames “misinformation.” https://arstechnica.com/science/2021/07/ever-forget-stuff-you-may-have-alzheimers-says-maker-of-56k-alzheimers-drug/
    “Biogen executives used their earnings day to take aim at critics and the media, saying the federal approval of the company’s new Alzheimer’s drug, Aduhelm, “has been the subject of extensive misinformation and misunderstanding.”” https://www.axios.com/biogen-aduhelm-q2-earnings-misinformation-c55ed753-8cd0-4f6e-bd61-c1b93b7979da.html

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