FDA official behind Alzheimer's drug scandal steps down

[LiberalArkie]

The Food and Drug Administration official who allegedly had an inappropriately cozy relationship with the maker of the controversial Alzheimer's drug Aduhelm is stepping down from his role, effective immediately, according to numerous media reports.

Billy Dunn, head of the FDA's neuroscience office, has been with the agency for around 18 years, during which he was involved in several high-profile drug approvals. But he gained notoriety in the wake of the shocking 2021 approval of Aduhelm, a drug that has not been shown to be effective against Alzheimer's and carries risks of serious brain swelling.

In 2020, the FDA's independent advisory committee voted nearly unanimously that the agency should not approve the drug (11 of 12 committee members voted against, with one voting "uncertain" ). Yet, the approval went through anyway, and Aduhelm's maker, Biogen, went on to set the exorbitant price of $56,000 for a year's worth of treatment. Outside researchers called the approval "disgraceful," three advisory members resigned in protest, and Medicare Part B premiums rose by record amounts to accommodate covering the pricey drug for Alzheimer's patients desperate for new treatments.

Subsequent media and congressional investigations alleged that Dunn had an off-the-books meeting with Biogen's head scientist two years prior, which kicked off an unusually close collaboration in the lead-up to the approval. For instance, a congressional report released in December 2022 found that some portions of Biogen's documents regarding the drug were written by the FDA and that the agency worked with the company to create briefing documents together. The congressional report concluded that the FDA failed to follow its own rules in its "atypical" interactions with Biogen and that it "inappropriately collaborated" with the company. It also called Aduhelm's price "unjustifiably high."

Snip

https://arstechnica.com/science/2023/02/fda-official-behind-alzheimers-drug-scandal-steps-down/

[riversedge]

1. He got greedy--and the FDA will pay the price with a loss of its reputation.

[crickets]

6. Sadly true. nt

[erronis]

8. I hope that Biogen and Dunn are tainted into the far distant future.

There need to be radioactive bio-markers placed on people and companies like this that prevent them from ever being trusted in the future.

Unfortunately, this capitalist and corporate-loving country will probably reward both.

[BootinUp]

2. To the greatest page. Nt

[dalton99a]

3. The asshole is corrupt to the core - there is a lucrative career ahead

[markodochartaigh]

4. As an RN I could have been fired for accepting ten dollars from a patient.

At that time all RN's were classified as management and we had to work unpaid overtime, or if we stayed at least a full hour we were paid straight time. And one third of every dollar that the hospital corporation brought in went to administration according to the local newspaper. I know how much Medicare Part B increased for each enrollee, what will Mr Dunn's punishment be?

[CountAllVotes]

5. Medicare recipients paid for it already

If you noticed that Medicare Part B went down to $165.00 this year from $170.00 last year, that is because it was jacked up and ready to go to pay for the "new" Alzheimer's drug in 2022.

Once there was no new Alzheimer's drug to be had, they dropped Part B to $165.00 this year!

I think those of us paying for Part B deserve a refund!

[delisen]

7. The amount of the Medicare increase was enormous

I wonder if there is a Criminal investigation.

[erronis]

9. Hope there is a criminal investigation. The perps (real people) should pay the price.

Not the taxpayers and patients.

[CountAllVotes]

11. that's right!

I wonder how much we got stuck for in this fraudulent game?

[PurgedVoter]

10. Here is another article.

https://www.science.org/content/blog-post/underside-aducanumab-approval

I think the company involved should no longer be allowed to work in the industry. Management and owners need to pay the price.

[CountAllVotes]

12. +1

n/t