Third FDA advisor resigns after Biogen's Alzheimer's drug approval
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- เผยแพร่เมื่อ 10 มิ.ย. 2021
- A third FDA advisor has resigned following last week's controversial accelerated approval of Biogen's Alzheimer's drug. For access to live and exclusive video from CNBC subscribe to CNBC PRO: cnb.cx/2NGeIvi
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.
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.
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It’s all about money, helping people and their safety are a thing of the past. Sad really.
Every morning I wake up, bizarre-o world gets more and more bizarre-o. I'm literally losing my mind now.
you are not alone
Don't do that, or they'll give you the Alzheimer's drug. 😲
When an endeavor has no merit, you withdraw to protect your own reputation.
The drug has unproven value and an extremely high price tag, Unaffordable for 90% of American households.
So refreshing to see powerful people in the fda stand up for what pharma’s been doing for years !!
@1:12 "fda is not making decisions based on science" and likely not interest of peoples health in that case. So what are they basing decisions on $$ obviously smh.
But placebos of plasma and hydro for covid that killed patients is just a bad day
What happened? CORRUPTION, that's what happened.
BUY $SAVA!!!
This sounds like approval
Based on MISINFORMATION
Wow the whole story is vague. The exiting advisor’s statement sounds like a extreme double speak to say the FDA is corrupt, but I’m not sure because of the highfalutin language. Can our reporters simply offer a bottom-line interpretation please?
Sounds like they’re leaving because the FDA isn’t listening to them. But yeah, they’re most likely corrupt.
The reporting here is 100% clear. The advisory panel recommended 10-0-1 to not approve the drug at this time because of the data.
The $FDA$ allows not listing Neurotoxic Aluminum on food labels! Eg Neurotoxic Aluminum silently used in cheese in high levels: 1 as salt emulsifier to make surface nice and melting better, 2 as caking agent to keep slices separated! It is labelled on table salt using E numbers and most common one now is Neurotoxic Aluminum based. Also used in flour, garlic powder, other spice powders, drink powders, most POWDERS. If anything like salt is listed as ingredient, then the Neurotoxic Aluminum does not have to be labelled! So wherever there is salt... Oh and Neurotoxic Aluminum is also used to keep your thoughts separated. Happy Alzheimer's Day!
This wasn't about Alzheimer drug. It was about approval of vaccines for EUA.
You are clueless!
The truth will come out very soon.
As usual profit over lives is involved.
Stock will lose altitude so fast the investors ears will pop.
They don't want to be connected to whats going to come.
What’s disturbing about this is that despite 10 no’s the FDA went ahead and approved it so what do you think happened with the COVID-19 advisory panel
That’s a very valid point. The way you can get past that legitimate concern is to look to the doctor’s and scientist’s opinions that worked on the trials for the vaccines. They are all unanimous in their support of the vaccines. The opposite is true with this Biogen drug.
They fought Burzynski for over 20 years human lives are just numbers for the FDA
This is just like in Rise of the Planet of the Apes when Will Rodman (played by James Franco) quit after the approval of ALZ-113 (Alzheimer's cure) and then an ape uprising occured as a result followed by a global pandemic.
The precedent=profit.
Trash drug.
😈😈😈
Because there are problems. 1Corinthians 3:16,17* donot defile your Christian body temple of God with injections.