Third FDA panel member quits over Alzheimer’s drug approval

https://globalnews.ca ^ | Updated June 11, 2021 10:24 am | By Julie Steenhuysen and Carl O'Donnell

[Red Badger]

A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency’s decision to approve Biogen Inc’s Alzheimer’s disease treatment despite the committee’s recommendation against doing so.

Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.

“My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees … because I didn’t think that the firm recommendations from the committee in this case … were appropriately integrated into the decision-making process,” Kesselheim said in an email.

He cited FDA’s decision to approve Sarepta Therapeutic Inc’s drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.

Stat News first reported his departure.

On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA’s approval of Aduhelm.

Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday.

The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved, citing inconclusive evidence that the drug was effective.

The FDA on Monday gave the drug “accelerated approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s, rather than proof of a clear benefit against the disease.

[cuban leaf]

Clash of the titans.

Something stinks here, but I’m not sure which side is the good guys.

[No_Mas_Obama]

Imagine the media coverage if this happened if President Trump was in office. As it stands, the alleged head of the US actually needs this drug just to make it thru the next few years.

[viewfromthefrontier]

The FDA, CDC are not in the business of listening to science anymore. Need to clear out the naysayers and fill their panel with yes men!

[D_Idaho]

Ha! They obviously don’t understand Science.

[Macoozie]

a Harvard guy . . . Mayo clinic guy . . . both quit over not being listened to.

Aren’t these the Experts, that help Goobermint follow the science?

Meh . .. . what do two white guys know anyway?

/s

[nuconvert]

“The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved, citing inconclusive evidence that the drug was effective.”

Interesting

[rainee]

Follow the money

[alternatives?]

You are correct. Where is the term “Biden Administration” in the article.

[Fai Mao]

Altimeters is such a horrible disease. I cannot imagine a side effect that would be worse. What’s the drug going to do, make you lose your mind?

[Jim Noble]

There is no such thing as “following the science”.

[Pollard]

What’s the drug going to do, make you lose your mind?

Evidently it doesn't do anything but make some people richer

[BipolarBob]

but I’m not sure which side is the good guys.

There may not be any good guys. Just corrupt and corrupter. The only thing you can count on is that nobody is on our side.

[consult]

And likely to cost Medicare billions....for something that doesn’t work!

[redgolum]

The FDA is pretty much captured by big phrama, who has no interest in curing anyone.

That isn’t new.

The fact that three officials publicly quit over this IS new.

[libertylover]

Something stinks here, but I’m not sure which side is the good guys.

Exactly, and the latest person to quit the committee is a Professor of Medicine at Harvard Medical School. Fair or not, I put him in the category of the far-left until proven otherwise.

[null and void]

Bring Out Your Dead

Post to me or FReep mail to be on/off the Bring Out Your Dead ping list.

The purpose of the “Bring Out Your Dead” ping list (formerly the “Ebola” ping list) is very early warning of emerging pandemics, as such it has a high false positive rate.

The false positive rate was 100%.

At some point we may well have a high mortality pandemic, and likely as not the “Bring Out Your Dead” threads will miss the beginning entirely.

*sigh* Such is life, and death...

Quarantine the sick. Protect the vulnerable. Hang the guilty. Free everyone else.

[Bob434]

Put Dr fauci In charge, he will straighten everything gout

[Red Badger]

[Tench_Coxe]

Now imagine this with regard to Covid.....