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NOT COVID: Huge new scandal threatens to engulf FDA Comment on this post ↓
September 7th, 2021 by Warren Swil

Hasty OK of costly,


unproven Alzheimers’ drug

draws intense scrutiny

Three months ago the Food and Drug Administration – in a move that took many by surprise – granted “accelerated approval” for a wildly expensive but unproven new drug to treat Alzheimer’s disease.

Acting FDA Director Dr. Janet Woodcock

The move has been followed by a cascading series of protests and intense scrutiny.
The drug, Aducanumab (branded Aduhelm for marketing) was developed by Biogen Inc. It will cost patients about $56,000 per year. FDA approval could cost Medicare billions.
Two House committees have already launched probes of the approval process. Even the FDA acting director has asked the HHS inspector general to investigate.
The multiple probes indicate something serious is amiss. What is already known stinks to high heaven!

On Sept. 2, the two House committee chairpersons jointly sent a lengthy letter demanding extensive documentation from the FDA.
The response – due in just over a week — will be critical. This saga has a lot further to unravel.
“We are concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm,” wrote Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Oversight and Reform Chairwoman Carolyn B. Maloney (D-NY) .
“FDA granted accelerated approval for the drug despite concerns raised by experts — including the agency’s own staff and members of FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNS Advisory Committee) — about the drug’s clinical benefit and the use of the accelerated approval pathway for Aduhelm.
“We are also concerned by reports of unusual coordination (emphasis added) between FDA and Biogen throughout the drug’s approval process.”
The 13-page letter goes on to demand a huge list of documentation including records of the extensive communications between regulators and Biogen.
The deadline for delivering this massive amount of information is Sept. 16 – just two weeks from the date of the letter.
The “unusual coordination” is the crux of the issue. Normally, the regulators and the regulated keep a respectable distance from each other. Not this time.
It is almost a classic case of “regulatory capture” — a term that entered the vernacular during the presidency of the notoriously corrupt Jacob Zuma of South Africa.
What it refers to is when an entity being regulated by a government agency uses its money, power and influence to sway the decision of the regulator in its favor.
A news release accompanying the House members’ letter focused on this: “Pallone and Maloney also raised concerns about reports of atypical coordination between FDA and Biogen throughout the drug’s approval process, and indications that interactions between FDA and Biogen may have been contrary to FDA’s own guidance for staff engagement with sponsors during drug development.”
Can you smell the stench yet?
At least part of the blame, however, rests with Congress itself.

Gold turns to dust

A 1992 law allows the FDA to fund itself by levying fees on companies seeking drug approvals. These fees amount to a significant part of the agency’s budget for the staff of the reviewing entity.
It’s virtually a built-in conflict of interest.
Among the controversies raised by the rapid approval was the labeling of Aduhelm, which initially allowed doctors to prescribe it for “anyone with an Alzheimer’s diagnosis.”
A month after the initial approval, the FDA revised the labeling to apply only to those “with mild cognitive impairment or mild dementia.”
This issue was explored in considerable detail Sept. 2 by Farhad Manjoo in the New York Times article America Desperately Needs a Much Better F.D.A.

In his extensive analysis of the FDA (which includes considerable mention of Aduhelm) Manjoo also notes another crucial factor: the well-known, frequent exchange of personnel between the FDA and the companies it regulates.
“The revolving door between the FDA and the industry spins so fast, we could tap it as a source of renewable power,” he wrote, pointing out that Scott Gottlieb, FDA director from 2017 to 2019, now works for Pfizer. No wonder Pfizer got the very first Covid-19 vaccine ever approved!
Sounds like a recipe for disaster to me.
The FDA rose to international prominence in the early 1960s by being one of few regulators globally with the foresight to prevent the thalidomide disaster.
But this position may no longer be justified. Manjoo deserves the last word on this (for now):
“Both Donald Trump and President Biden have referred to FDA approval as the “gold standard” of drug safety. It is a pretty tarnished gold.”

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