FDA Alzheimer's Drug Corruption Scandal

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In summary, the FDA has approved an Alzheimer's drug, Aducanumab, despite its lack of effectiveness and serious side effects, going against the unanimous recommendations of their scientific panel. This decision has led to the resignation of three members in protest. While there is no direct evidence of corruption, an investigation may provide more insight into the approval process and potential conflicts of interest. Additionally, a previous article from 2018 sheds light on undisclosed conflicts of interests within the FDA's advisory panel.
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  • #2
Approving the drug is clearly a bad decision, but where is the evidence for corruption?
 
  • #4
morrobay said:
Perhaps an investigation could answer that question. https://www.sciencemag.org/news/201...a-advisers-after-drug-approvals-spark-ethical

That's an article from 2018 about approval of a different drug. The article does suggest that there are sometimes undisclosed conflicts of interests in the FDA approval process, but no direct evidence of any in the Aducanumab approval. It's certainly a possibility that should be investigated, and I'm sure many are.
 
  • #5
The article also seems to suggest conflicts of interests for the advisory panel. But in the case of Aducanumab, nobody in the advisory panel voted for approval.
 
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1. What is the FDA Alzheimer's drug corruption scandal?

The FDA Alzheimer's drug corruption scandal refers to the controversy surrounding the approval of the drug Aduhelm (aducanumab) by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease. The drug was approved based on limited evidence and against the recommendation of the FDA's own advisory committee, leading to accusations of corruption and conflicts of interest.

2. What is Aduhelm and how does it work?

Aduhelm is a monoclonal antibody drug designed to target and remove beta-amyloid plaques in the brain, which are believed to contribute to the development of Alzheimer's disease. The drug is administered via intravenous infusion every four weeks and is intended to slow the progression of the disease.

3. What evidence was used to support the approval of Aduhelm?

The FDA approved Aduhelm based on two phase 3 clinical trials, one of which showed a reduction in beta-amyloid plaques in the brain, while the other did not show any significant improvement in cognitive function. The drug's manufacturer, Biogen, also provided additional data from an ongoing study, but it has not yet been peer-reviewed or published.

4. Why is the approval of Aduhelm controversial?

The approval of Aduhelm has been met with controversy due to the limited and conflicting evidence of its effectiveness, as well as concerns about its high cost and potential side effects. Additionally, it was approved under the FDA's accelerated approval pathway, which allows for the approval of drugs based on a surrogate endpoint (such as a reduction in beta-amyloid plaques) rather than clinical outcomes (such as improved cognitive function).

5. What is being done to address the controversy surrounding Aduhelm's approval?

In response to the controversy, three members of the FDA's advisory committee resigned in protest, and the FDA has announced plans to investigate the drug's approval process. Additionally, some experts have called for the drug to be withdrawn or for further studies to be conducted to better understand its effectiveness and potential risks.

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