Biogen Dumps Dubious Alzheimer's Drug After Profit-Killing FDA Scandal (arstechnica.com) 29
An anonymous reader quotes a report from Ars Technica: Biotechnology company Biogen is abandoning Aduhelm, its questionable Alzheimer's drug that has floundered on the market since its scandal-plagued regulatory approval in 2021 and brow-raising pricing. On Wednesday, the company announced it had terminated its license for Aduhelm (aducanumab) and will stop all development and commercialization activities. The rights to Aduhelm will revert back to the Neurimmune, the Swiss biopharmaceutical company that discovered it.
Biogen will also end the Phase 4 clinical trial, ENVISION, that was required by the Food and Drug Administration to prove Biogen's claims that Aduhelm is effective at slowing progression of Alzheimer's in its early stages -- something two Phase 3 trials failed to do with certainty. In the announcement, Biogen noted it took a financial hit of $60 million in the fourth quarter of 2023 to close out its work on Aduhelm, which the company at one point reportedly estimated would bring in as much as $18 billion in revenue per year.
Biogen will also end the Phase 4 clinical trial, ENVISION, that was required by the Food and Drug Administration to prove Biogen's claims that Aduhelm is effective at slowing progression of Alzheimer's in its early stages -- something two Phase 3 trials failed to do with certainty. In the announcement, Biogen noted it took a financial hit of $60 million in the fourth quarter of 2023 to close out its work on Aduhelm, which the company at one point reportedly estimated would bring in as much as $18 billion in revenue per year.
"Trust the science" crowd is quiet today (Score:1, Insightful)
Where are my "trust the science" peeps? The folks that would literally shove poison into their veins because they were told to do so by pharmaceutical companies who I'm sure only had your best interests at ( a very enlarged ) heart?
These companies and their government mouth pieces ( FDA ) are not your friends, and do not care if you live or die, as long as you trust THEIR science.
Re:"Trust the science" crowd is quiet today (Score:5, Insightful)
IIRC, the "trust the science" people said that drug should never have been approved. "Science" is not "the government".
Re:"Trust the science" crowd is quiet today (Score:5, Informative)
Furthermore, the folks at CMS (who control Medicare reimbursements) and most private insurers looked at the science, said "fuck that", and determined they wouldn't pay for a super-expensive, ineffective drug.
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IIRC, the "trust the science" people said that drug should never have been approved. "Science" is not "the government".
Science is not the people who make drugs either.
Wanna know what to trust? The science used to prove that Aduhelm was ineffective, and Biogen serving up bullshit quackery.
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Where are my "trust the science" peeps? The folks that would literally shove poison into their veins because they were told to do so by pharmaceutical companies who I'm sure only had your best interests at ( a very enlarged ) heart?
The science said "this has not yet been proven to work, let's wait and see." The people with the disease said "OMG, if there's even a reasonable chance it will work, approve it now!"
The people saying "wait" were shouted down by the people saying "move fast," a triumph of hope over science.
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Where are my "trust the science" peeps? The folks that would literally shove poison into their veins because they were told to do so by pharmaceutical companies who I'm sure only had your best interests at ( a very enlarged ) heart?
The science said "this has not yet been proven to work, let's wait and see." The people with the disease said "OMG, if there's even a reasonable chance it will work, approve it now!"
The people saying "wait" were shouted down by the people saying "move fast," a triumph of hope over science.
A reboot of the Laetrile experience. https://en.wikipedia.org/wiki/... [wikipedia.org] Desperate people clutching at hope. Might as well give them sugar pills.
While not certain, I'm beginning to suspect that dementia is pretty much a natural thing, not affecting everyone, but if you live long enough... Human brains might just have an expiry. It isn't all at the same time or age, but so far it seems like a possibility. This isn't the only part of human bodies that isn't designed for even the life extension we have ena
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Laetrile just shows that quackery is alive and well and that many people are still gullible enough to want to believe. The worst part is not just the people who used it as an alternate treatment when all other treatments failed, but those who actively avoided conventional treatments for a treatable cancer who instead went down to Mexico to get alternative solutions from people who had been criminally convicted of fraud. Some people are predisposed to believe the people who make the miracle cure in the bas
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Laetrile just shows that quackery is alive and well and that many people are still gullible enough to want to believe. The worst part is not just the people who used it as an alternate treatment when all other treatments failed, but those who actively avoided conventional treatments for a treatable cancer who instead went down to Mexico to get alternative solutions from people who had been criminally convicted of fraud. Some people are predisposed to believe the people who make the miracle cure in the basement while distrusting doctors, which is just baffling.
Yup, so we have people trying to use anti-parasitics like dewormers or anti-malaria drugs to treat a viral infection, while a simple injection makes the infection much less likely to kill them, or ravage their cardiopulmanary systems and minds, as another example.
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Huh? The science is literally what's going on here. Meanwhile you idiots dose up on supplements that peddled by idiots on YouTube with fake science.
Re: "Trust the science" crowd is quiet today (Score:2)
what works and what does not? (Score:2)
Re: what works and what does not? (Score:1)
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My issue with tylenol/paracetamol is the relatively low amount that can cause liver damage, which can be a problem when so many over the counter medications contain it
It is worth noting that Naproxyn also reduces fever without impact on the liver, but has its own host of issues including bleeding in the stomach and long term effects on tendons
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They stopped giving kids aspirin because some kids would develop Reye's syndrome
It turns out that giving aspirin to children during a viral illness—most often influenza (the flu) or chickenpox—can lead to a potentially fatal condition called Reye's syndrome. Reye's is defined by sudden brain damage and liver function problems. It can cause seizures, coma, and death.
The incidence of Reye's has decreased dramatically since recommendations for giving aspirin to children were changed.
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Aspirin and Tylenol (acetominephen) absolutely work. However... Acetominephen is dangerous in higher dosages and can cause liver failure, dosages not that much higher than the daily limit listed on bottles. Aspirin is generally safe, except again when overused it can cause gastrointestinal bleeding. Worse, there had been "children's doses" of Tylenol which is misleading - because some formulations are actually _stronger_ than those for adults, because the stronger formula means you take much less of it
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Are they subsidized? (Score:2)
imho, drugs created to treat amyloid plaque=turds (Score:3)
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Since we now know the theory that amyloid protein plaque causes alzheimers was based on falsified data, why would we expect any drugs created to treat the amyloid protein plaque to be effective?
Well, hope springs eternal. I expect that there will be many more Alzheimer's treatments. And they don't have to work at all. As long as the patient takes them every day until they expire.
The big issue with these treatments is how do you determine if they are working? Dementia patients have good days and bad days even if untreated. So if they have a good day, the pharma can say "See? SEE? our dug is working!"
The "slowing of progress" is bullshit anyhow. If instead of a few years mild, a few years med
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Since we now know the theory that amyloid protein plaque causes alzheimer's was based on falsified data, why would we expect any drugs created to treat the amyloid protein plaque to be effective?
I think there is still a lot of evidence that amyloid protein plaque has some relationship with alzheimer's. There was a recent report of clusters of early onset alzheimer's among those receiving growth hormone from for example:
"Researchers say a handful of people who received human growth hormone from the pituitary glands of deceased donors have gone on to develop early onset Alzheimer’s – likely because the hormones used were contaminated with proteins that seeded the disease in their brains."
They pretty much bought (Score:2)