Third Member of US FDA Advisory Panel Resigns Over Alzheimer's Drug Approval 61
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's Alzheimer's disease treatment despite the committee's recommendation against doing so. Reuters reports: 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'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.
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.
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.
Good (Score:5, Insightful)
These advisors seem to have a spine, and resignation is the professional, ethical way to handle being treated like a rubber stamp.
Re:Good (Score:5, Insightful)
That's the problem when principled people leave their post. Their replacement won't have that troublesome spine.
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Quite the catch-22 isn't it? Stay ineffectually, or loudly resign and hope to trigger some response from higher up.
Rock, meet hard place.
You can do that... once (Score:3)
These advisors seem to have a spine, and resignation is the professional, ethical way to handle being treated like a rubber stamp.
The problem with this tactic is that you can only do it once.
It comes up some times when a military commander is given orders that he doesn't think will work. The commander can resign his commission but you can only do that once and then no longer oppose the decision, and they will replace you with someone less competent.
I think the same principle applies here: resigning takes the person out of the fight, while staying on the job allows them to continue to voice objections into the future. Also, they would
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What is the point of staying on if your professional recommendation, along with the rest of the panels opinion is just ignored? The problem seems to be corruption.
Same with the officer, what is the point of staying and always being forced to follow orders that you disagree with, though I guess in that case, perhaps next time his opinion will be respected as hopefully there isn't the corruption. OTOH, the corruption might be nepotism so the superior officers aren't very qualified.
Re:Good (Score:5, Informative)
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The 11-member committee voted NEARLY unanimously in November that Biogen's drug should not be approved,
So, not unanimous.
Anyway, the FDA got it right. When you have an untreatable terminal disease and you have a drug that shows promise but has inconclusive test results, you don't wait. You allow it and let people choose for themselves. Dead without trying to treat it is no better than dead with something that turns out to be snake oil.
My only complaint is that medicare and insurance will probably pay for it. They shouldn't be paying for a yet unproven treatment.
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Dead without trying to treat it is no better than dead with something that turns out to be snake oil.
My only complaint is that medicare and insurance will probably pay for it. They shouldn't be paying for a yet unproven treatment.
At a cost of about $55K a year for treatment? That's just likely a ripoff on everyone paying for it. You, me and the guy behind the tree.
Aduhelm is forecast to become the biggest selling drug of all time, making its approval one of the most momentous decisions the FDA has ever made. Was the agency right to take the decision it did, and what does the future hold for Biogen, biotech, and pharma in light of this decision?
https://seekingalpha.com/artic... [seekingalpha.com]
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These advisors seem to have a spine, and resignation is the professional, ethical way to handle being treated like a rubber stamp.
THE way? I prefer leaks of documents proving precisely how we're being fucked over.
Very sketchy (Score:5, Informative)
Half the studies say it's worthless. No benefit found. But it does have one benefit, to make one drug company a lot of money. Apparently that is good enough for the FDA.
If the drug clearly worked out might be worth approving, but that is not the case.
Re:Very sketchy (Score:5, Interesting)
One thing that differentiates FDA-Approved drugs from alternative medicine is the presence of controlled-study-obtained evidence that it actually works. Undermining that reduces our professional doctors to little more than snake-oil salesmen.
I realize that people with the condition are desperate, and it feels morally wrong to block them from something that might work, due to a lack of evidence. But the greater evil is taking their (and their family's) money in exchange for snake oil.
We need the FDA to be a reliable barrier that stands between us and false medicines that don't work. If they fall down on that job, then they become as bad as all the crazy conspiracy-theorists already say they are.
Re:Very sketchy (Score:4, Interesting)
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You realize that 100 years ago, Progressives were arguing the exact opposite? Read The Century Magazine to get a flavor.
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Well, one thing about actual progressives is evidence can change their opinion.
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This. Sometimes, the right thing to do is the hardest thing to do. Nobody said this was supposed to be easy.
Re:Very sketchy (Score:5, Interesting)
He was lacking qualification for the panel anyway (Score:2)
There's a solution (Score:3)
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You have to dilute it so that there isn't a single molecule left first.
Homeopathy is authorized on the basis that it is as safe as pure water, because that's what it is. Unlike real drugs that may be toxic in addition to being ineffective.
could it be allowed? (Score:3)
So the evidence shows that this drug causes brain inflammation, reduces beta-amyloid plaques, and has no clear affect on Alzheimer's Disease. But we'd also like to allow people to make their own informed choices.
Imagine if the FDA approved it so that people could make their own choice, but also enforced "truth in efficacy claims" as follows: for any ad or promotion, and for any pill bottle label, if the law courts determine that 5% or more of the target audience public would conclude from it that the drug helps with dementia, then there's a penalty. The penalty can be that if there are more than three such findings in a year then the approval is rescinded immediately, to be brought back only if there's a successful appeal.
This way, if an ad says "proven to help with the plaques that come with alzheimers", and a panel 100 of people see the ad and 10 of them come away thinking that the drug helps with dementia, then it's in violation. This would encourage Biogen to advertise it carefully, and their financial bottom line would be tied to how accurately they advertise it.
Re:could it be allowed? (Score:5, Insightful)
People cannot make informed choices about something this far into expert territory. Period.
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People cannot make informed choices about something this far into expert territory. Period.
Maybe people with Alzheimers can't, but otherwise speak for yourself.
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Nope. I speak as an expert in multiple fields and I have the experience, the insight and the education to _know_ that people in general cannot make expert decisions and that even experts in related fields will have a hard time making an expert decision for a specific field. So, no, I am not speaking for myself here. I am speaking for you as well, because clearly you are not an expert in anything that matters and hence have no clue about the complexities involved. You are incompetent and unaware of it.
In the
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Not on something like this. Sorry.
Re:could it be allowed? (Score:4, Insightful)
and this is the problem with not approving safe drugs that may not be effective at one thing or another
your doctor is supposed to know something about what he is prescribing you, and certainly knows more about your case than the boys at the FDA
Re:could it be allowed? (Score:4, Interesting)
Wow ethics (Score:2)
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And don't forget - he would call this objector part of the "deep state" and try to question their motives and their ability.
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There's a simple solution here (Score:5, Insightful)
The FDA approved the drug, but required Biogen to carry out a Phase 4 study to see if it actually works (they gave Biogen far far too long to carry out that study, but that's a different story).
So, there's a simple solution grounded in consumer law: if you buy something, and it doesn't do what you promised it would, you can get a refund.
Approve the drug, require a comprehensive Phase 4 trial, and require Biogen to provide a full refund unless the Phase 4 trial conclusively proves that it works.
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> to provide a full refund unless the Phase 4 trial conclusively proves that it works.
It sounds like you are suggesting that the consumers of this new drug become "beta" testers. I don't take kindly to paying through the nose for an experiemental drug that MIGHT help me but will DEFINETLY have some nasty side effects.
I tend to agree with the poster who said this should be classified as a homeopathic drug. If patients
From what I've read about (Score:1)
Biogen's drug is it shouldn't have been approved. I'm my opinion the FDA approved it anyway. There is way too much money behind this drug for it not to be approved wheather it works or not.
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I'm guessing when they saw that it prevented amyloid proteins from aggregating, they assumed that it would prevent the disease. A reasonable guess, since the proteins are associated with the disease. In pours the money, for what seemed like a sure bet. When it turned out removing the protein doesn't cure the disease, the suits still felt entitled to market it, because they "worked so hard" on it. (In other words, paid researchers to work so hard.)
I feel like there should be a name for this kind of decay of
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From what I understand, the committee said something to the effect of: "we'll approve it because it removes beta amyloid so well". But what they didn't say is: we'll approve it because it improves the condition of Alzheimer's so well. I think that really says something about why they approved it.
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FDA (Score:1)
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That was the case over a half century ago, before the thalidomide problem.
America did NOT approve thalidomide because it wasnt safe, even though it was effective.
Europe approved thalidomide because is was effective, even though it was not safe.
So the thalidomide disaster slammed Europe.
Europes response was to start worrying about safety.
Americas response, even though it had no reason to change anything, was to add efficacy to FDA requirements.
The very failed system that Europ
What constitutes "conclusive evidence" here? (Score:2)
corporate welfare (Score:2)
The approval is just corporate welfare for Biogen, at the expense of Medicare and therefore all Medicare beneficiaries. FDA is politicized just like everything else.
What a bunch of whiners (Score:2)
Aduhelm may be the biggest selling drug all time (Score:2)
The committee voted 10-0 against approval of Aducanumab, but the FDA ultimately decided to follow its own path, amid accusations the agency has been aligning itself too closely with Biogen.
A large proportion of the biotech and pharmaceutical industry also expressed its dissatisfaction at the decision made by the FDA, arguing that not only is Aducanumab's efficacy incredibly weak, the drug also is unsafe - causing dangerous side effects, most notably in patients who respond best to treatment with it.
It's a far from ideal situation that will continue to divide the industry, while it's also likely to shape the future of drug-development industry and drug approval process for years, if not decades to come.
Aduhelm is forecast to become the biggest selling drug of all time, making its approval one of the most momentous decisions the FDA has ever made. Was the agency right to take the decision it did, and what does the future hold for Biogen, biotech, and pharma in light of this decision?
Read the article: https://seekingalpha.com/artic... [seekingalpha.com]
Is this the hydroxychloroquine [cochrane.org] of Alzheimer drugs?
Just with a much larger price.