F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

Section:

---
URL: https://www.nytimes.com/2021/06/07/health/aduhelm-fda-alzheimers-drug.html
ISSN: 0362-4331
type: article-newspaper
title: F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
author:
  - given: Pam
    family: Belluck
  - given: Rebecca
    family: Robbins
issued:
  - day: 7
    year: 2021
    month: 6
source: NYTimes.com
section: Health
abstract: Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years
  and the first to attack the disease process. But some experts say there’s not enough
  evidence it can address cognitive symptoms.
language: en-US
container-title: The New York Times
---

is an article about the decision of the FDA to approve an experimental Alzheimer drug, Aducanumab, for use despite opposition from the scientific community. It was published by the New York Times on June 7th, 2021, the day of the decision by the FDA.  It was authored by Pam Belluck and Rebecca Robbins.  It raises the over-arching question of whether patient need or scientific rigor should determine the approval of experimental medicies [@FxB26E4E].

## Details

[Granted approval | Recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval for the drug to be used but required Biogen to conduct a new clinical trial.].  The FDA granted approval for the drug to be used but is requiring Biogen, the company producing it, to conduct a new clinical trial.

[Significant doubts | significant doubts]. The F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. [@Ix4D05E7]

[Patient advocacy groups had lobbied vigorously for approval | Patient advocacy groups had lobbied vigorously for approval]. There is strong support from those personally affected by Alzheimer's for the drug's approval because there are no other promising medications for one diagnosed with Alzheimer's at this time. The last time an Alzheimer's drug received approval from the FDA was in 2003.

[Expressed skepticism...for a post-market trial | Several experts expressed skepticism that Biogen would be able to recruit many participants in the United States for a post-market trial because patients who can get a drug from their doctors are often reluctant to take the chance of receiving a placebo in a clinical trial.] The FDA ruled that Biogen, the company behind the drug, must complete a Phase 4 trial even though the drug has already received approval. Post-market trials are incredibly difficult to perform and unlikely to suceed, however, as patients who can get the drug from a doctor are reluctant to take the chance of receiving a placebo in the trial. [@Ix4D05E7]

[Crux of the controversy | The crux of the controversy over the drug involved two Phase 3 trials with results that contradicted each other: One suggested the drug slightly slowed cognitive decline while the other trial showed no benefit. The trials were stopped early by a data monitoring committee that found the drug didn’t appear to be showing any benefit. Consequently, over a third of the 3,285 participants in those trials were never able to complete them.] The heart of the issue is that two Phase 3 trials for the drug produced results that contradicted each other. One showed the drug had benefit, the other showed that it had none.

## Reference