Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

  

Category:  News & Politics

Via:  vic-eldred  •  2 weeks ago  •  11 comments

By:   Berkeley Lovelace Jr. (CNBC)

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug
A third member of a key FDA panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned.

S E E D E D   C O N T E N T



A third member of a key Food and Drug Administration advisory panel has resigned over the agency's controversial decision to approve Biogen's new Alzheimer's drug, Aduhelm, CNBC has learned.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency's decision on Biogen "was probably the worst drug approval decision in recent U.S. history," according to his resignation letter obtained by CNBC.

"At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug's effect on brain amyloid was likely to help patients with Alzheimer's disease," he wrote in resigning from the FDA's Peripheral and Central Nervous System Advisory Committee.

He wrote it was "clear" to him that the agency is not "presently capable of adequately integrating the Committee's scientific recommendations into its approval decisions."

"This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system," he said.

Shares of Biogen surged 38% on Monday after the FDA approved the biotech company's drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer's and the first new medicine for the disease in nearly two decades.

VIDEO2:4902:49 Evidence to approve of Biogen's Alzheimer's drug was not 'sufficient,' says Penn's Dr. Jason Karlawish The News with Shepard Smith

Biogen's drug targets a "sticky" compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

The FDA approved the drug under a program called accelerated approval, which is usually used for cancer medications, expecting the drug would slow the cognitive decline in Alzheimer's patients. The agency granted approval on the condition that Biogen conducts another clinical trial.

The agency's decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

At least two other FDA panel members have resigned as a result of the agency's decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter have also submitted resignation letters.

"I was very disappointed at how the advisory committee input was treated by the FDA," Knopman told Reuters. "I don't wish to be put in a position like this again."

Federal regulators have faced intense pressure from friends and family members of Alzheimer's patients asking to fast-track the drug, scientifically known as aducanumab, but the road to regulatory approval has been a controversial one since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the drug after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab "reduced clinical decline in patients with early Alzheimer's disease."

Alzheimer's experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won't prescribe aducanumab because of the mixed data package supporting the company's application.

- Reuters contributed to this report.


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Vic Eldred
Professor Principal
1  seeder  Vic Eldred    2 weeks ago

This is what happens when the politics leads the science instead of "Following the science."

I think George Orwell would understand it.

 
 
 
Thomas
Sophomore Guide
1.1  Thomas  replied to  Vic Eldred @1    2 weeks ago

Funny, but this was known at the time of approval. 

So, when this drug was approved, you were all for it, regardless of the known controversial science and were applauding the FDA. Now, three months later, you are suddenly acting like this was not a known objection and that it is all somehow the Progressives fault. 

To quote you :

Good old Biogen, right over here in Cambridge MA.  To think this breakthrough may have been missed!

There is hope for Joe Biden.  

Hmmmmmmmm

 
 
 
Vic Eldred
Professor Principal
1.1.1  seeder  Vic Eldred  replied to  Thomas @1.1    2 weeks ago
Hmmmmmmmm

But Biden isn't going to reassure the unvaccinated when he has scientists over at the FDA resigning.

 
 
 
Perrie Halpern R.A.
Professor Principal
1.1.2  Perrie Halpern R.A.  replied to  Vic Eldred @1.1.1    2 weeks ago

Vic,

They are not resigning over the vaccine. They are resigning over this drug. And none of this has to do with Biden, does it?

The fact that this is known, is great. We should be glad that the facts are out there. 

 
 
 
Vic Eldred
Professor Principal
1.1.3  seeder  Vic Eldred  replied to  Perrie Halpern R.A. @1.1.2    2 weeks ago
They are not resigning over the vaccine.

Because?

 
 
 
Perrie Halpern R.A.
Professor Principal
1.1.4  Perrie Halpern R.A.  replied to  Vic Eldred @1.1.3    2 weeks ago

Because it went through proper testing and just completed full investigation. They followed the science. The FDA is structured that all departments are separated. 

Here is a chart of how the FDA is presently structured:

 
 
 
Vic Eldred
Professor Principal
1.1.5  seeder  Vic Eldred  replied to  Perrie Halpern R.A. @1.1.4    2 weeks ago
Because it went through proper testing and just completed full investigation.

It was full, but was it Proper? :

"Federal regulators have faced intense pressure from friends and family members of Alzheimer's patients asking to fast-track the drug, scientifically known as aducanumab, but the road to regulatory approval has been a controversial one since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the drug after all."



 
 
 
Perrie Halpern R.A.
Professor Principal
1.1.6  Perrie Halpern R.A.  replied to  Vic Eldred @1.1.5    2 weeks ago

I am talking about the vaccine being full and proper. 

Obviously, there is an issue with this drug. There often is. 

 
 
 
Vic Eldred
Professor Principal
1.1.7  seeder  Vic Eldred  replied to  Perrie Halpern R.A. @1.1.6    2 weeks ago

Let us hope for the best and we can only hope that the 3 resignations don't add to the skepticism of the unvaccinated.

 
 
 
Tessylo
Professor Principal
3  Tessylo    2 weeks ago

I was waiting for this to be blamed on President Biden.

 
 
 
Ozzwald
Professor Quiet
3.1  Ozzwald  replied to  Tessylo @3    2 weeks ago
I was waiting for this to be blamed on President Biden.

I ordered some hot wings last week, they forgot the side of ranch with them.  Somehow, I suspect, certain people here would blame Biden for my not getting my side of ranch.

 
 
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