Wednesday, June 9, 2021

2 Members of FDA's drug advisory committee quit, acknowledging the "sham process" / WaPo

Heated debate continues over the clearance of Aduhelm despite opposition from agency’s outside experts

Two members of a Food and Drug Administration advisory panel resigned this week after the agency’s contentious decision to approve an Alzheimer’s drug over the objections of its outside advisers.

David S. Knopman, a neurologist at the Mayo Clinic, said Wednesday in an email to The Washington Post that he did not “wish to be part of a sham process” that ultimately resulted in the agency’s approval Monday of Biogen’s Aduhelm, also known as aducanumab.

He also shared the email he sent to FDA officials saying that he was resigning immediately. He told the officials: “The whole saga of the approval of aducanumab … made a mockery of the [advisory] committee’s consultative process. While I realize that the committee is advisory, the approval of aducanumab appears [to] have been foreordained...”

Knopman, in his email to the FDA, cited “biased questions” posed by the FDA’s review staff at the meeting last November of the Peripheral and Central Nervous System Drugs Advisory Committee.

What is interesting is that tomorrow FDA's sister Vaccine advisory committee meets to consider data needed to authorize or license Covid vaccines for children.  The FDA is usually not interested in anyone's advice, but federal rules require that these committees exist.  So FDA attempts to use them to cover its butt on controversial decisions. And a prime way it does that is asking "biased questions."

Watch for another sham process tomorrow.  Watch for the questions FDA has its panel consider. Why was Arnold Monto selected by FDA as its temporary Chair for all the Covid vaccine advisory meetings?  Because he rules them with an iron fist.

 Janet Woodcock became infamous for masterminding a (criminal imho) process of drug approval and controlling the advisory process, when she was head of CBER the first time.

The bottom line is that today's FDA approves drugs and vaccines when the evidence shows they don't work or are very unsafe. Today we got one more example of this. Hopefully after tomorrow's meeting we won't get another.

UPDATE June 10:  A third member of the FDA advisory committee quit today!

It turns out that despite the fact that not one member of the FDA Advisory Committee voted to approve Aduhelm, the FDA recently approved this Alzheimer therapy anyway, relying on an alternative measure of activity.

As Statnews reportssince the FDA's decision, three members of that FDA Advisory Panel have quit.

1. Neurologist J.Perlmutter, a member of the FDA’s expert panel said he quit the committee “due to this ruling by FDA without further discuss with our advisory committee.”

2. Neurologist David Knopman of the Mayo Clinic.

3. Dr. Aaron Kesselheim, director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law, said Aduhelm’s approval didn’t just set “a dangerous precedent” for what kind of evidence an Alzheimer’s therapy would need to show to get the green light, “but even more broadly for the idea that a company can turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for FDA approval,” he told STAT in an email.

In his letter of resignation to the FDA, Kesselheim said Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”

Both Perlmutter and Kesselheim voted against the drug, while Knopman was recused from the November hearing as he had already staked out a public position critical of the drug’s trial results.

Earlier this year, Kesselheim, and two other panelists published a paper in JAMA outlining what they saw as the flaws of the therapy.

1 comment:

Anonymous said...

What a brood of vipers.