Of course, zlheimer's can be reversed with 20mg of lithium orotate a
day, so who cares?
Re: Medical Mafia
*Member of FDA's expert panel resigns over controversial Alzheimer's
therapy approval*
by Andrew Joseph
June 8, 2021
https://www.statnews.com/2021/06/08/...mers-approval/
'Following the Food and Drug Administration's polarizing
authorization of the Alzheimer's therapy Aduhelm on Monday, a member
of an agency advisory committee that recommended against the drug's
approval has resigned.
Neurologist Joel Perlmutter of Washington University in St. Louis, a
member of the FDA's expert panel for nervous system therapies, told
STAT in an email that he had quit the committee on Monday 'due to
this ruling by the FDA without further discussion with our advisory
committee.'
The advisory committee, which convened in November, couldn't have
been more openly skeptical of the drug, also known as aducanumab.
Ten of the 11 panelists found that there was not enough evidence to
show it could slow cognitive decline. The 11th voted 'uncertain.'
But the FDA still approved the treatment on Monday. On top of the
potentially massive implications for patients, clinicians, and
health care spending, the decision also raised questions about the
role of the advisory committees -- and what it meant that the agency,
in its final adjudication, bucked the very panel it had convened.
'This isn't the first time when I was on a committee where the
committee voted one way and the FDA decided another,' said
biostatistician Scott Emerson, a professor emeritus at the
University of Washington, who has served on many advisory committees
in different disease areas. 'This was the first time that nobody
voted for approval of this drug -- nobody -- and they went against that.'
The FDA does not have to follow its advisory committees'
recommendations -- one study found the agency went against the
experts 21% of the time from 2008 to 2015 -- but those overrulings
generally came when the votes were closer. The FDA often convenes
the panels when there is uncertainty around whether or how to
approve new products, and there are different 'ad comms' for
different types of medications.
With Aduhelm, the story is also more complicated than the FDA just
rebuking the expert panel. The FDA granted the Biogen therapy what's
called an accelerated approval, based not on firm evidence the drug
slowed cognitive decline -- which even the FDA acknowledged was not
clear -- but on a 'surrogate endpoint' that the therapy cleared toxic
protein plaques in patients' brains. In the FDA's view, that finding
'is reasonably likely to predict a clinical benefit to patients.' It
also said Biogen would have to run another trial to confirm a
clinical benefit, though the results of that aren't due for nearly
another decade.
But during the advisory committee meeting last November, FDA
officials explicitly said they were not considering approving
aducanumab based on a surrogate endpoint. y Dunn, the director
of the FDA's Office of Neuroscience, made it clear: 'We're not using
the amyloid as a surrogate for efficacy.' That meant the panelists
were not asked to consider that possibility.
Related: Biogen isn't worried about backlash to 'bewildering' price
of Alzheimer's drug
So on Monday when the agency announced it had indeed given Aduhelm
the OK based on amyloid levels as a surrogate endpoint, it left
experts on the panel scratching their heads. Trials of other
amyloid-busting therapies have found that they didn't result in
clinical benefits.
What had happened, Dunn explained in a letter to the chair of the
panel Monday, was that after the panel hearing, there were 'further
discussions' within the agency that 'raised further consideration of
the accelerated approval pathway.'
Related: Elation, pride, and a slew of questions: Clinical trial
participants reflect on their own complicated reactions to Aduhelm
approval
'We recognize that there has been tremendous public interest in
aducanumab and differing viewpoints on the extensive and complicated
data supporting the application for aducanumab,' Dunn wrote. 'Our
discussions leading up to the decision to grant an accelerated
approval for aducanumab considered a wide range of views, both
external and internal to FDA. We appreciate the comments from the
advisory committee members and can assure you that we listened
carefully and viewed the meeting proceedings as an important source
of input as we discussed the appropriate action.'
To Aaron Kesselheim, an advisory committee member and the director
of Brigham and Women's Hospital's Program on Regulation,
Therapeutics, and Law, 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.
Related: 'The price is bewildering': The cost of Biogen's
Alzheimer's drug may lead payers to erect roadblocks
It's no surprise that some members of the panel denounced the FDA's
approval, and not simply because of their votes. During the November
hearing, some of them criticized how the data was being discussed
and the evidence Biogen had submitted. Earlier this year, Emerson,
Kesselheim, and a third panelist published a paper in JAMA outlining
what they saw as the flaws of the therapy.
Still, Emerson, the biostatistician, said he would serve on another
advisory committee if asked. (The panels have some permanent
members, but for individual hearings, they invite 'temporary
members,' which included Emerson in the case of aducanumab.)
Trending Now: Third member of FDA expert committee resigns over
controversial Alzheimer's therapy decision
It is important, Emerson said, for outside experts to have a voice
in the decision-making process.
Matthew Herper contributed reporting. '
See also...
- https://www.apmresearchlab.org/10x/lithium-mining-for-evs-sustainability
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