costs $56,000 per year
July 30, 2021 3:49 PM Subscribe
A few weeks ago, the FDA approved a costly Alzheimer's drug developed by Biogen, but for what benefit?
1. There is not strong evidence that Amyloid beta plaques causes Alzheimer’s disease, even if aducanumab showed a reduction in those plaques.
2. Aducanumab did not show any real-life outcomes like improvement in cognitive outcomes or reduction in mortality.
1. There is not strong evidence that Amyloid beta plaques causes Alzheimer’s disease, even if aducanumab showed a reduction in those plaques.
2. Aducanumab did not show any real-life outcomes like improvement in cognitive outcomes or reduction in mortality.
Shades of Vioxx.
posted by They sucked his brains out! at 4:02 PM on July 30, 2021
posted by They sucked his brains out! at 4:02 PM on July 30, 2021
Mod note: Thread was briefly deleted because I misread a timestamp. Sorry about that, carry on!
posted by cortex (staff) at 4:20 PM on July 30, 2021 [4 favorites]
posted by cortex (staff) at 4:20 PM on July 30, 2021 [4 favorites]
STAT has an article tying approval to a specific FDA official who became a true believer. Paywalled so I haven't read the whole thing but an excerpt here.
Biogen still hasn't published a peer reviewed write up of the final trial apparently. Biogen's spin ("JAMA requested edits we don't want to make so we're looking for another a journal") is pretty weak to anyone familiar with scientific journals--"edits" are often not phrasing but suggestions you need more evidence or a different conclusion.
This just seems a disaster. I get the frustration after so many Alzheimer's drugs failed, but you can't just shrug and approve the net one to come along because you despair of finding something better.
posted by mark k at 4:28 PM on July 30, 2021 [16 favorites]
Biogen still hasn't published a peer reviewed write up of the final trial apparently. Biogen's spin ("JAMA requested edits we don't want to make so we're looking for another a journal") is pretty weak to anyone familiar with scientific journals--"edits" are often not phrasing but suggestions you need more evidence or a different conclusion.
This just seems a disaster. I get the frustration after so many Alzheimer's drugs failed, but you can't just shrug and approve the net one to come along because you despair of finding something better.
posted by mark k at 4:28 PM on July 30, 2021 [16 favorites]
Gotta say, I’m really not a fan of trustworthy institutions burning their credibility for no reason during a global pandemic.
posted by AirExplosive at 4:49 PM on July 30, 2021 [26 favorites]
posted by AirExplosive at 4:49 PM on July 30, 2021 [26 favorites]
Maker of dubious $56k Alzheimer’s drug offers cognitive test no one can pass:
"No matter how you answer—even if you say you never experience any of those issues—the quiz will always prompt you to talk with your doctor about cognitive screening. The results page even uses your zip code to provide a link to find an Alzheimer's specialist near you."
Of note, this is the same Biogen whose March 2020 executive meeting (when they presumably decided to go forward with diddling the FDA with their fudged results) was the first covid superspreader event in the US. If you put something like this in a movie, you'd get flack for having an over-the-top villain.
posted by basalganglia at 4:51 PM on July 30, 2021 [40 favorites]
"No matter how you answer—even if you say you never experience any of those issues—the quiz will always prompt you to talk with your doctor about cognitive screening. The results page even uses your zip code to provide a link to find an Alzheimer's specialist near you."
Of note, this is the same Biogen whose March 2020 executive meeting (when they presumably decided to go forward with diddling the FDA with their fudged results) was the first covid superspreader event in the US. If you put something like this in a movie, you'd get flack for having an over-the-top villain.
posted by basalganglia at 4:51 PM on July 30, 2021 [40 favorites]
Speaking of STAT, how about De Staat? It has relevance. Really. NSFW.
posted by Splunge at 4:52 PM on July 30, 2021 [1 favorite]
posted by Splunge at 4:52 PM on July 30, 2021 [1 favorite]
This is exactly why physicians need to remain independent professionals and not cogs in a machine that rubber stamp whatever it is their patients saw on TV that they want prescribed so they can stick to their 4 patients-an-hour schedule which keeps hospitals, pharma, and insurance companies happy and rich. I'd like to think that my colleagues would push back on prescribing this because they are smart and ethical, but I know that's not how it works in much of US healthcare.
posted by Slarty Bartfast at 4:58 PM on July 30, 2021 [11 favorites]
posted by Slarty Bartfast at 4:58 PM on July 30, 2021 [11 favorites]
pretty sure Aducanumab is one of the Old Gods
posted by taquito sunrise at 5:36 PM on July 30, 2021 [24 favorites]
posted by taquito sunrise at 5:36 PM on July 30, 2021 [24 favorites]
I don't work with Biogen or on anything related to this. But I have a colleague who does. And the day the approval was made public he was ranting to all of us about how the approval is BS and the result of a statistical fishing expedition — according to him, when they got negative results they sliced and diced their data until they found a population that looks like they benefit if you squint real hard.
This is a third-hand anecdote so take it with a pile of salt. And while I think he understands stats, dealing with stats is not his day job. But that's how I learned this was being approved.
posted by Tehhund at 5:41 PM on July 30, 2021 [13 favorites]
This is a third-hand anecdote so take it with a pile of salt. And while I think he understands stats, dealing with stats is not his day job. But that's how I learned this was being approved.
posted by Tehhund at 5:41 PM on July 30, 2021 [13 favorites]
Can anyone help me understand exactly what "it would cost Medicare " means here:
> This is about cold hard cash for Biogen – in an article in The Atlantic, Nicholas Bagley, JD, and Rachel Sacks, JD, MPH, estimate that if the drug is prescribed to just one-third of eligible Alzheimer’s disease patients in the USA, it would cost Medicare $112 billion a year. That would far more than any other drug in that system.
Does the sequence of events go something like:
1. pharma company develops some new drug
2. drug is approved for use by FDA despite it having side effects and not appearing to be effective in actually treating anything.
3. pharma company announces the price of the drug will be $56k / year
4. desperate patients / families decide they are willing to try the drug as they don't have a better option
5. doctors proscribe the drug despite it probably being useless and on the whole harmful (?)
6. the cost of the "treatment" from this drug is largely paid for by the public through Medicare (???)
I am puzzled by step 6. What prevents the US federal government or whoever administers Medicare during price negotations with Biogen fromlaughing at the proposed $56k price tag and telling biogen to go get fucked "we're not paying $56k for a treatment that is only distinguishable from cheaper treatments such as placebo sugar pills / homeopathy in terms of severity of side effects like risk of brain bleeding and swelling."
( i don't work in anything pharma related or understand US drug pricing, i am a small-scale capitalist and do hold 10 shares in biogen and stand to profit by $500 due to BIIB share price appreciation since the announcement of this apparently useless/actively-harmful drug )
posted by are-coral-made at 5:58 PM on July 30, 2021 [2 favorites]
> This is about cold hard cash for Biogen – in an article in The Atlantic, Nicholas Bagley, JD, and Rachel Sacks, JD, MPH, estimate that if the drug is prescribed to just one-third of eligible Alzheimer’s disease patients in the USA, it would cost Medicare $112 billion a year. That would far more than any other drug in that system.
Does the sequence of events go something like:
1. pharma company develops some new drug
2. drug is approved for use by FDA despite it having side effects and not appearing to be effective in actually treating anything.
3. pharma company announces the price of the drug will be $56k / year
4. desperate patients / families decide they are willing to try the drug as they don't have a better option
5. doctors proscribe the drug despite it probably being useless and on the whole harmful (?)
6. the cost of the "treatment" from this drug is largely paid for by the public through Medicare (???)
I am puzzled by step 6. What prevents the US federal government or whoever administers Medicare during price negotations with Biogen from
( i don't work in anything pharma related or understand US drug pricing, i am a small-scale capitalist and do hold 10 shares in biogen and stand to profit by $500 due to BIIB share price appreciation since the announcement of this apparently useless/actively-harmful drug )
posted by are-coral-made at 5:58 PM on July 30, 2021 [2 favorites]
What prevents the US federal government or whoever administers Medicare during price negotations with Biogen from laughing
My understanding is Medicare is prohibited by law from negotiating drug prices.
posted by majick at 6:51 PM on July 30, 2021 [11 favorites]
My understanding is Medicare is prohibited by law from negotiating drug prices.
posted by majick at 6:51 PM on July 30, 2021 [11 favorites]
>> What prevents the US federal government or whoever administers Medicare during price negotations with Biogen from laughing
> My understanding is Medicare is prohibited by law from negotiating drug prices.
what the actual fuck.
posted by are-coral-made at 6:52 PM on July 30, 2021 [14 favorites]
> My understanding is Medicare is prohibited by law from negotiating drug prices.
what the actual fuck.
posted by are-coral-made at 6:52 PM on July 30, 2021 [14 favorites]
what the actual fuck.
Sokath, his eyes uncovered.
posted by saturday_morning at 6:54 PM on July 30, 2021 [28 favorites]
Sokath, his eyes uncovered.
posted by saturday_morning at 6:54 PM on July 30, 2021 [28 favorites]
If you're wondering about #5 on your list, Alzheimer's is an incredibly cruel and slow way to die. People are absolutely desperate for any treatment that does literally anything. The power of relentlessly hounding your doctor until they give you what you want can be used for good (convincing them that no, you really don't have female hysteria) or for ill (getting them to prescribe a $56,000 infusion that at best does nothing).
posted by threementholsandafuneral at 7:02 PM on July 30, 2021 [11 favorites]
posted by threementholsandafuneral at 7:02 PM on July 30, 2021 [11 favorites]
There's a March 2021 article by Emmarie Huetteman about the political state of Medicare drug price negotiations:
> Dr. Aaron Kesselheim, a Harvard Medical School professor who researches the drug industry and will testify at the hearing, said there is no practical reason the federal government cannot negotiate a price based on independent assessments of a drug’s clinical benefits — as every other industrialized nation, and even some state Medicaid programs, do. “The real reason is the drug industry’s lobbying power,” he said.
Populist working-class republican agenda vs small-government "free-market" capitalism republican agenda:
> Despite then-President Donald Trump’s keen interest in lowering drug prices, most proposals by both Democrats and Republicans on Capitol Hill went nowhere under Republican leaders, who argue government intrusion in the free market would hamper future innovation. They point to an estimate from the Congressional Budget Office suggesting the cuts to drugmakers’ revenue under Medicare negotiations could lead to nearly 40 fewer new drugs being developed in the next 20 years.
> The government currently approves about 30 drugs per year.
...
> Though they disagree on some of the details [...] Democrats are united on the need to address drug pricing. Biden, progressives like Sanders and moderates such as Sen. Joe Manchin (D-W.Va.) support proposals that would generally allow the government to set restrictions on brand-name drugs. Researchers say these drugs, initially priced without any competition or regulation, are a leading factor driving up costs for Americans, their employers and the government.
I'd disagree with the characterisation of drugs "initially priced without any competition or regulation" -- it seems as if there's very heavy regulation in terms of patent law etc creating monopolies for the companies to exploit as incentives for developing the drugs and gaining FDA approval, and further government regulation preventing government buyers from negotiating prices during the period a company has been granted a monopoly license.
posted by are-coral-made at 7:22 PM on July 30, 2021 [1 favorite]
> Dr. Aaron Kesselheim, a Harvard Medical School professor who researches the drug industry and will testify at the hearing, said there is no practical reason the federal government cannot negotiate a price based on independent assessments of a drug’s clinical benefits — as every other industrialized nation, and even some state Medicaid programs, do. “The real reason is the drug industry’s lobbying power,” he said.
Populist working-class republican agenda vs small-government "free-market" capitalism republican agenda:
> Despite then-President Donald Trump’s keen interest in lowering drug prices, most proposals by both Democrats and Republicans on Capitol Hill went nowhere under Republican leaders, who argue government intrusion in the free market would hamper future innovation. They point to an estimate from the Congressional Budget Office suggesting the cuts to drugmakers’ revenue under Medicare negotiations could lead to nearly 40 fewer new drugs being developed in the next 20 years.
> The government currently approves about 30 drugs per year.
...
> Though they disagree on some of the details [...] Democrats are united on the need to address drug pricing. Biden, progressives like Sanders and moderates such as Sen. Joe Manchin (D-W.Va.) support proposals that would generally allow the government to set restrictions on brand-name drugs. Researchers say these drugs, initially priced without any competition or regulation, are a leading factor driving up costs for Americans, their employers and the government.
I'd disagree with the characterisation of drugs "initially priced without any competition or regulation" -- it seems as if there's very heavy regulation in terms of patent law etc creating monopolies for the companies to exploit as incentives for developing the drugs and gaining FDA approval, and further government regulation preventing government buyers from negotiating prices during the period a company has been granted a monopoly license.
posted by are-coral-made at 7:22 PM on July 30, 2021 [1 favorite]
I'd like to think that my colleagues would push back on prescribing this because they are smart and ethical,
Forget the ethics of doctors, I work in pharma and know a lot of very senior people who would be livid if our company tried to get something like this approved.
I know a lot of people outside industry may not believe this, but there are absolutely people who make decisions who want to see bad drugs cancelled internally and then rejected.
The problem is of course that (1) people who invest a lot of time on a project aren't unbiased when evaluating how good it really is and (2) not everyone cares, especially if billions are at stake. It's easier for us to kill a project if we believe it's bad at the start, before we've spent a decade and billions working on it; it's another reason we *really* need the FDA to reject things at the end if they don't work.
it would cost Medicare $112 billion a year. That would far more than any other drug in that system.
The top selling US drugs are ~$20 billion annually. They also actually work. I would hope Medicare Part D doesn't cover this (it doesn't cover everything) but there will be a lot of patient advocates insisting it does. It's not clear to me what will actually happen. Can't believe it'll be purchased at the anything like the level quoted though.
I would say if this *did* work, I suspect it would probably save the health care system money without even factoring in improvement to human quality of life.
posted by mark k at 7:30 PM on July 30, 2021 [13 favorites]
Forget the ethics of doctors, I work in pharma and know a lot of very senior people who would be livid if our company tried to get something like this approved.
I know a lot of people outside industry may not believe this, but there are absolutely people who make decisions who want to see bad drugs cancelled internally and then rejected.
The problem is of course that (1) people who invest a lot of time on a project aren't unbiased when evaluating how good it really is and (2) not everyone cares, especially if billions are at stake. It's easier for us to kill a project if we believe it's bad at the start, before we've spent a decade and billions working on it; it's another reason we *really* need the FDA to reject things at the end if they don't work.
it would cost Medicare $112 billion a year. That would far more than any other drug in that system.
The top selling US drugs are ~$20 billion annually. They also actually work. I would hope Medicare Part D doesn't cover this (it doesn't cover everything) but there will be a lot of patient advocates insisting it does. It's not clear to me what will actually happen. Can't believe it'll be purchased at the anything like the level quoted though.
I would say if this *did* work, I suspect it would probably save the health care system money without even factoring in improvement to human quality of life.
posted by mark k at 7:30 PM on July 30, 2021 [13 favorites]
Monoclonal antibodies (the "-ab" drugs) have a high development cost and are very fiddly to manufacture, but that's an insane price.
posted by kersplunk at 7:44 PM on July 30, 2021
posted by kersplunk at 7:44 PM on July 30, 2021
There is increasing horizontal integration of the US medical system where health insurance companies buy PBAs and PBMs, hospitals buy other hospitals, labs, radiology facilities, ASCs, and and medical groups. For some time, a majority of doctors are salaried employees of hospitals or regional medical providers. Instead of government single payer we may be approaching a unique American system, the corporate single provider, at least regionally. But then since, in most cases, the government acts in corporate interest, this is not surprising. This approval is basically another example of regulatory capture, fostered by years of medical industry appointments to the FDA, etc., and revolving door appointments to-and-from industry, by both parties.
I’m less sanguine about physicians’ ethics. If you think employed physicians are not going to prescribe an FDA-approved drug when the hospital will make money (professional fees, pharmacy mark-up [hint: the $56k is the list price, not what the hospital pharmacy will pay], infusion center charges, recommended brain imaging after infusion, labs, and so on, you are mistaken. This drug will be aggressively marketed to patients and doctors and prescribed, and not only for those with early dementia but in more advanced cases for which there is no evidence of benefit.
posted by sudogeek at 8:09 PM on July 30, 2021 [6 favorites]
I’m less sanguine about physicians’ ethics. If you think employed physicians are not going to prescribe an FDA-approved drug when the hospital will make money (professional fees, pharmacy mark-up [hint: the $56k is the list price, not what the hospital pharmacy will pay], infusion center charges, recommended brain imaging after infusion, labs, and so on, you are mistaken. This drug will be aggressively marketed to patients and doctors and prescribed, and not only for those with early dementia but in more advanced cases for which there is no evidence of benefit.
posted by sudogeek at 8:09 PM on July 30, 2021 [6 favorites]
Biogen is the former Martin Shkreli company, n'est pas ?
posted by NoThisIsPatrick at 8:42 PM on July 30, 2021
posted by NoThisIsPatrick at 8:42 PM on July 30, 2021
Since this is a physician administered drug, it would (generally) be covered under Part B, not Part D.
In Part B, the physician purchases the drug and is reimbursed by Medicare for the cost, less the co-pay, plus a 6% add-on. The add-on is intended to ensure that the physician does not lose money due to price variations, administration costs, shipping fees, etc...
This makes the concept of Medicare negotiation a bit more complicated under Part B, as Medicare isn't purchasing the product from the drug company. They are reimbursing the physician who purchased it from the drug company. At best, they could make it so that the physician would lose money on the infusion unless the physicians/hospitals/health systems themselves are able to negotiate a lower price from the drug company.
This reimbursement structure also creates additional incentive for the provider to prescribe the drug beyond the pleading of desperate patients, where that incentive is directly related to the price of the drug.
posted by exit at 9:13 PM on July 30, 2021 [4 favorites]
In Part B, the physician purchases the drug and is reimbursed by Medicare for the cost, less the co-pay, plus a 6% add-on. The add-on is intended to ensure that the physician does not lose money due to price variations, administration costs, shipping fees, etc...
This makes the concept of Medicare negotiation a bit more complicated under Part B, as Medicare isn't purchasing the product from the drug company. They are reimbursing the physician who purchased it from the drug company. At best, they could make it so that the physician would lose money on the infusion unless the physicians/hospitals/health systems themselves are able to negotiate a lower price from the drug company.
This reimbursement structure also creates additional incentive for the provider to prescribe the drug beyond the pleading of desperate patients, where that incentive is directly related to the price of the drug.
posted by exit at 9:13 PM on July 30, 2021 [4 favorites]
> Biogen is the former Martin Shkreli company, n'est pas ?
No. Shrekli's company was Turing Pharma:
> When Martin Shkreli, the CEO of Turing Pharmaceuticals, announced he was jacking up the price of a 62-year-old antiparasitic drug from $13.50 to $750 a pill, few were rushing to his side to congratulate him on his amazing business acumen. [...]
> Back in February, Shkreli founded Turing around drug/delivery assets from his controversial former corporate alma mater, Retrophin. In August, he raised $90 million in private funding and bought exclusive rights to market a drug called Daraprim from Impax Laboratories for $55 million. That made Turing the sole supplier in the United States of the only US Food and Drug Administration (FDA)-approved (and, therefore, reimbursable) treatment for toxoplasmosis.
> What then transpired was the unusual sight of industry lobby organizations Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America both distancing themselves from Turing and Shkreli. Biogen CEO George Scangos chimed in saying that Shkreli had “dropped down a storm” on an undeserving industry. Novartis's Joe Jimenez noted that companies like Turing were “taking advantage of inflated biotech valuations.” The real muck hit the media fan, however, on September 21 when US presidential hopefuls Hillary Clinton, Donald Trump and Bernie Sanders weighed in, contributions that somehow made the prospect of reform to pharmaceutical pricing more real.
-- nature biotechnology 2015
posted by are-coral-made at 9:44 PM on July 30, 2021 [2 favorites]
No. Shrekli's company was Turing Pharma:
> When Martin Shkreli, the CEO of Turing Pharmaceuticals, announced he was jacking up the price of a 62-year-old antiparasitic drug from $13.50 to $750 a pill, few were rushing to his side to congratulate him on his amazing business acumen. [...]
> Back in February, Shkreli founded Turing around drug/delivery assets from his controversial former corporate alma mater, Retrophin. In August, he raised $90 million in private funding and bought exclusive rights to market a drug called Daraprim from Impax Laboratories for $55 million. That made Turing the sole supplier in the United States of the only US Food and Drug Administration (FDA)-approved (and, therefore, reimbursable) treatment for toxoplasmosis.
> What then transpired was the unusual sight of industry lobby organizations Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America both distancing themselves from Turing and Shkreli. Biogen CEO George Scangos chimed in saying that Shkreli had “dropped down a storm” on an undeserving industry. Novartis's Joe Jimenez noted that companies like Turing were “taking advantage of inflated biotech valuations.” The real muck hit the media fan, however, on September 21 when US presidential hopefuls Hillary Clinton, Donald Trump and Bernie Sanders weighed in, contributions that somehow made the prospect of reform to pharmaceutical pricing more real.
-- nature biotechnology 2015
posted by are-coral-made at 9:44 PM on July 30, 2021 [2 favorites]
Biogen is the former Martin Shkreli company, n'est pas ?
No, and this is really different than Shkreli style shenanigans. I'm not saying it's better; there are a lot of threads to pull on.
Shkreli wasn't a pharma person. He was basically a financier who cornered the supply of an off patent existing drug and jacked up the price. There was no societal upside to what he did, unless you *really* buy into extreme versions of pro-market, pro-capital arguments.
Biogen is a mainstream pharma company that does R&D. They do legitimate research, spending billions and I'm sure people who worked on this were trying to make a Alzheimer's drug that worked. (Even out of self interest--getting the FDA to approve a drug that doesn't work isn't a low-risk plan.) So they've done some good things, put research money in socially desirable places and if this particular one had worked it would have a been great for everyone.
But this undercuts a lot of what they've done. From my point of view there's always the people at a company who want to just try and sell something, as opposed to create something worth selling, and if this actually sells in the billions those people will be more empowered.
posted by mark k at 9:56 PM on July 30, 2021 [9 favorites]
No, and this is really different than Shkreli style shenanigans. I'm not saying it's better; there are a lot of threads to pull on.
Shkreli wasn't a pharma person. He was basically a financier who cornered the supply of an off patent existing drug and jacked up the price. There was no societal upside to what he did, unless you *really* buy into extreme versions of pro-market, pro-capital arguments.
Biogen is a mainstream pharma company that does R&D. They do legitimate research, spending billions and I'm sure people who worked on this were trying to make a Alzheimer's drug that worked. (Even out of self interest--getting the FDA to approve a drug that doesn't work isn't a low-risk plan.) So they've done some good things, put research money in socially desirable places and if this particular one had worked it would have a been great for everyone.
But this undercuts a lot of what they've done. From my point of view there's always the people at a company who want to just try and sell something, as opposed to create something worth selling, and if this actually sells in the billions those people will be more empowered.
posted by mark k at 9:56 PM on July 30, 2021 [9 favorites]
Here's drug chemist Derek Lowe's take on it. (From his well known In the Pipeline blog.)
As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – I don’t believe that Biogen really demonstrated efficacy. No problem apparently. The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy.
[...]
the FDA has, for expediency’s sake, bought into the amyloid hypothesis although every single attempt to translate that into a beneficial clinical effect has failed.
To me, this looks more like corruption than simple every-day regulatory capture. I hope the Department of Justice looks deep into this before too much taxpayer money is wasted on this drug.
posted by monotreme at 11:10 PM on July 30, 2021 [7 favorites]
As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – I don’t believe that Biogen really demonstrated efficacy. No problem apparently. The agency seems to have approved it based on its demonstrated ability to clear beta-amyloid, and is asking Biogen to run a confirmatory trial to show efficacy.
[...]
the FDA has, for expediency’s sake, bought into the amyloid hypothesis although every single attempt to translate that into a beneficial clinical effect has failed.
To me, this looks more like corruption than simple every-day regulatory capture. I hope the Department of Justice looks deep into this before too much taxpayer money is wasted on this drug.
posted by monotreme at 11:10 PM on July 30, 2021 [7 favorites]
I swear I remember reading that Turing changed names to Biogen. But I am wrong.
I am vaguely aware that Shkreli was a money guy not a pharma guy. It seems that Turing is called Vyera Pharmaceuticals, now.
Thank you for the correction.
posted by NoThisIsPatrick at 11:11 PM on July 30, 2021 [2 favorites]
I am vaguely aware that Shkreli was a money guy not a pharma guy. It seems that Turing is called Vyera Pharmaceuticals, now.
Thank you for the correction.
posted by NoThisIsPatrick at 11:11 PM on July 30, 2021 [2 favorites]
There is a special place reserved in my heart for aducanumab and all the providers who are going to prescribe it. A special place full of the finest curses, tongue-lashings, imprecations, and invective. Never has a news story made me feel so acutely that my expertise is pointless. I heard that doctors can actually make money prescribing this drug! like, $3,360 per patient per year, if that Bloomberg reporting is right! that's some serious pocket money to take to the casino! And then I thought, so maybe that's why that geriatrician of my acquaintance recently went on a tear about how it wasn't a doctor's role to exercise judgment independent of the FDA, it was just the doctor's role to prescribe, prescribe, prescribe.
In a way, it's nice to have something to be yell-at-clouds angry about that isn't COVID.
posted by eirias at 4:05 AM on July 31, 2021 [5 favorites]
In a way, it's nice to have something to be yell-at-clouds angry about that isn't COVID.
posted by eirias at 4:05 AM on July 31, 2021 [5 favorites]
while drug prices are kind of outrageous in general, $56K a year SOUNDS like a lot of money for a drug but it's very much in line with a lot of other newly developed treatments. If not less, signifigantly less. Humira can cost upwards of $84K a year.
https://www.singlecare.com/blog/most-expensive-drugs-2019/
Again I want to point out, as I did the last time this pile on started a few months ago:
As someone who has lost multiple family members to Alzheimer's related conditions - this is the FIRST AND ONLY drug on the market. It should inspire more $ and research to go into the field and maybe, just maybe, some progress/movement can be made. If not you get the despicable pleasure of watching your loved ones turn into an angry violent carrot. Or lose the ability to recognize their spouse of 50 years right in front of them.
It might just be that this is some small tiny little bit of hope that someone somewhere is attempting to find a solution for one of the most devastating and insidious fates that a loved one can be cursed with.
I know it's easy to get outraged at the new sparkly thing but- please think of what little bit of hope this might provide to those suffering and their families. Because this disease is a death sentence - FULL STOP. it's ugly and, I swear to god, the most heartbreaking thing I hope you never have to experience.
posted by djseafood at 6:07 AM on July 31, 2021 [8 favorites]
https://www.singlecare.com/blog/most-expensive-drugs-2019/
Again I want to point out, as I did the last time this pile on started a few months ago:
As someone who has lost multiple family members to Alzheimer's related conditions - this is the FIRST AND ONLY drug on the market. It should inspire more $ and research to go into the field and maybe, just maybe, some progress/movement can be made. If not you get the despicable pleasure of watching your loved ones turn into an angry violent carrot. Or lose the ability to recognize their spouse of 50 years right in front of them.
It might just be that this is some small tiny little bit of hope that someone somewhere is attempting to find a solution for one of the most devastating and insidious fates that a loved one can be cursed with.
I know it's easy to get outraged at the new sparkly thing but- please think of what little bit of hope this might provide to those suffering and their families. Because this disease is a death sentence - FULL STOP. it's ugly and, I swear to god, the most heartbreaking thing I hope you never have to experience.
posted by djseafood at 6:07 AM on July 31, 2021 [8 favorites]
No one is mad an Alzheimer's drug is being brought to market. People are mad that it both hasn't been proven to work while also having side effects so severe they have to be monitored for in a clinical setting. If it was proven to work people would be estatic even if it was twice as much.
posted by Mitheral at 6:29 AM on July 31, 2021 [31 favorites]
posted by Mitheral at 6:29 AM on July 31, 2021 [31 favorites]
The last time i saw my grandfather, he was convinced I was my uncle. I would love for there to be something that would have helped him, when talking to my grandmother half the time he thought she had died and he was speaking to her ghost.
To offer up (and approve) what amounts to an extremely expensive placebo? That’s the kind of thing that makes me wish I believed in hell. It’s incredibly amoral to move this to market, let alone approve it and spend tax dollars on it to enrich those who are passing it off as hope.
posted by fifteen schnitzengruben is my limit at 6:39 AM on July 31, 2021 [9 favorites]
To offer up (and approve) what amounts to an extremely expensive placebo? That’s the kind of thing that makes me wish I believed in hell. It’s incredibly amoral to move this to market, let alone approve it and spend tax dollars on it to enrich those who are passing it off as hope.
posted by fifteen schnitzengruben is my limit at 6:39 AM on July 31, 2021 [9 favorites]
Offering what is an expensive placebo with severe side effects isn't giving people actual hope. It's charging people in desperate situations for lies, lies that can cause damage beyond just false hope.
People who are upset about this aren't only disinterested observers. If this had been offered up as a legitimate option for my grandfather... it's honestly enraging to think about.
If they think they've found a subgroup of people who benefit from it, start a new trial targeting that subgroup and prove it.
posted by ghost phoneme at 7:02 AM on July 31, 2021 [12 favorites]
People who are upset about this aren't only disinterested observers. If this had been offered up as a legitimate option for my grandfather... it's honestly enraging to think about.
If they think they've found a subgroup of people who benefit from it, start a new trial targeting that subgroup and prove it.
posted by ghost phoneme at 7:02 AM on July 31, 2021 [12 favorites]
djseafood - these people are preying on exactly the kind of pain you describe.
posted by showbiz_liz at 7:02 AM on July 31, 2021 [15 favorites]
posted by showbiz_liz at 7:02 AM on July 31, 2021 [15 favorites]
It should inspire more $ and research to go into the field and maybe, just maybe, some progress/movement can be made
Why would it do that? Letting people charge money for a chemical that doesn't work reduces the incentive to invent something that does.
Everyone in pharma can do the math and know how much money they stand to make with a good drug. And we've always known we can get a good drug approved; the problem was inventing one. So as an industry we've put huge amounts of research dollars and time into trying to find a cure or even treatment. Lily and Merck especially have had expensive, high-profile failures that pretty much proved beta amyloid was not a plausible intervention point. This isn't the contribution they wanted to make, but it was still a contribution. Biogen, by obscuring the fact beneath spin and regulatory lobbying, is not contributing.
To me, this looks more like corruption than simple every-day regulatory capture
I don't see any evidence of that or reason to think that.
posted by mark k at 7:43 AM on July 31, 2021 [5 favorites]
Why would it do that? Letting people charge money for a chemical that doesn't work reduces the incentive to invent something that does.
Everyone in pharma can do the math and know how much money they stand to make with a good drug. And we've always known we can get a good drug approved; the problem was inventing one. So as an industry we've put huge amounts of research dollars and time into trying to find a cure or even treatment. Lily and Merck especially have had expensive, high-profile failures that pretty much proved beta amyloid was not a plausible intervention point. This isn't the contribution they wanted to make, but it was still a contribution. Biogen, by obscuring the fact beneath spin and regulatory lobbying, is not contributing.
To me, this looks more like corruption than simple every-day regulatory capture
I don't see any evidence of that or reason to think that.
posted by mark k at 7:43 AM on July 31, 2021 [5 favorites]
I've been speaking with someone who works in bio-pharma to assist in understanding what this drug is and how it works based on the public releases from the company & FDA. As I've said, I have a lot of personal reasons to have a better understanding of how this drug works, I may be looking down the barrel of this gun myself given my family history. So let's say I'm quite interested in any advancement and am not looking for some silver bullet. There is no cure for Alzheimer's and this is not being marketed as a "cure".
Fast track approval is not at all unusual and has very specific limits on how a drug can be marketed and even how the company can discuss it. It's not a blanket approval to allow the drug to be prescribed to anyone. It's a process that exists to allow new types of treatment to assessed in smaller numbers to get more clinical data. It will still take up to 10 years of ongoing data collection before the drug can be more widely distributed or fully approved by the FDA. Aducanumab is a bio-thereaputic anti-body treatment, these are proven, safe treatments.
There are two types of proteins identified as possible treatment routes; Amyloid beta & Tau. This is the furthest that any type of treatment has gotten so far in at least 20 years so this is very significant. How to clinically measure the results of the reduction of these plaques and it's impact on the quality of life is the most difficult thing to quantify. Aducanumab absolutely & unequivocally DOES reduce Amyloid beta plaques in the brain. The FDA has said as much and clearing the plaques does have an effect on the progress of the disease. How much and how it may improve the quality of life is what the ongoing studies are trying to prove.
As I said before this is not being marketed as a "cure" and it takes more time and more studies to understand how effective Aducanumab might slow the progress of the disease and improve quality of life for those suffering from Alzheimer's. Otherwise it's what? Good luck here's some Valium to help you sleep? The release of Aducanumab has already stimulated the bio-pharma market and there are already millions of more dollars being pushed into Alzheimer's treatment as a result of it's limited approval. This is a fact and is excellent news for future treatments.
I know we all want a boogeyman to blame and "Big Pharma" does need close scrutiny and strict regulation and Biogen or any company bringing a drug to market should always be held to a high standard. Biogen, for example, used fast track approval to help bring their MS drug to market and that was revolutionary in the field and improved the quality of life for MS sufferers around the world.
In the end I think this whole thing is a lot less cavalier that it may come off at first & I certainly understand being skeptical (Skeptics Society member here, hello!)
posted by djseafood at 10:14 AM on July 31, 2021 [3 favorites]
Fast track approval is not at all unusual and has very specific limits on how a drug can be marketed and even how the company can discuss it. It's not a blanket approval to allow the drug to be prescribed to anyone. It's a process that exists to allow new types of treatment to assessed in smaller numbers to get more clinical data. It will still take up to 10 years of ongoing data collection before the drug can be more widely distributed or fully approved by the FDA. Aducanumab is a bio-thereaputic anti-body treatment, these are proven, safe treatments.
There are two types of proteins identified as possible treatment routes; Amyloid beta & Tau. This is the furthest that any type of treatment has gotten so far in at least 20 years so this is very significant. How to clinically measure the results of the reduction of these plaques and it's impact on the quality of life is the most difficult thing to quantify. Aducanumab absolutely & unequivocally DOES reduce Amyloid beta plaques in the brain. The FDA has said as much and clearing the plaques does have an effect on the progress of the disease. How much and how it may improve the quality of life is what the ongoing studies are trying to prove.
As I said before this is not being marketed as a "cure" and it takes more time and more studies to understand how effective Aducanumab might slow the progress of the disease and improve quality of life for those suffering from Alzheimer's. Otherwise it's what? Good luck here's some Valium to help you sleep? The release of Aducanumab has already stimulated the bio-pharma market and there are already millions of more dollars being pushed into Alzheimer's treatment as a result of it's limited approval. This is a fact and is excellent news for future treatments.
I know we all want a boogeyman to blame and "Big Pharma" does need close scrutiny and strict regulation and Biogen or any company bringing a drug to market should always be held to a high standard. Biogen, for example, used fast track approval to help bring their MS drug to market and that was revolutionary in the field and improved the quality of life for MS sufferers around the world.
In the end I think this whole thing is a lot less cavalier that it may come off at first & I certainly understand being skeptical (Skeptics Society member here, hello!)
posted by djseafood at 10:14 AM on July 31, 2021 [3 favorites]
Aducanumab absolutely & unequivocally DOES reduce Amyloid beta plaques in the brain. The FDA has said as much and clearing the plaques does have an effect on the progress of the disease.
My understanding is that the former part (that it clears amyloid) is true and that the latter (that this does anything to improve the symptoms or progress of the disease) is quite unclear. This ties into the fundamental controversy in the field regarding the underlying causes of the disease - it’s hard to let go of the amyloid hypothesis because of the association between amyloid-related genes and familial Alzheimer’s, but there have been quite a few amyloid-targeting drugs and none of them have showed effectiveness.
One could argue that this represents hope for Alzheimer’s drugs on the pharma side - i.e. that the more money spent on the disease without coming up with any drugs the harder it is to justify even trying. But that’s not what an FDA approval is supposed to represent, a situation that is at best a patient and insurance funded extended clinical trial. And it could easily lead to more dollars thrown in the complete wrong direction if drugs directly targeting amyloid simply don’t work.
posted by atoxyl at 12:47 PM on July 31, 2021 [4 favorites]
My understanding is that the former part (that it clears amyloid) is true and that the latter (that this does anything to improve the symptoms or progress of the disease) is quite unclear. This ties into the fundamental controversy in the field regarding the underlying causes of the disease - it’s hard to let go of the amyloid hypothesis because of the association between amyloid-related genes and familial Alzheimer’s, but there have been quite a few amyloid-targeting drugs and none of them have showed effectiveness.
One could argue that this represents hope for Alzheimer’s drugs on the pharma side - i.e. that the more money spent on the disease without coming up with any drugs the harder it is to justify even trying. But that’s not what an FDA approval is supposed to represent, a situation that is at best a patient and insurance funded extended clinical trial. And it could easily lead to more dollars thrown in the complete wrong direction if drugs directly targeting amyloid simply don’t work.
posted by atoxyl at 12:47 PM on July 31, 2021 [4 favorites]
My father has Alzheimer's and is on a clinical trial of BAN2401, which I think is also known as Lecanemab and is another drug targetting plaques. He's been on it for a couple of years now. I'm his study partner so do most of the clinic visits with him, and the initial sign-up process. Goodness it's a grind. One of the things that makes me angry and sad about the whole process is that when he was originally told about the trial the doctor said "this will reverse the damage caused by your Alzheimer's". Felt like the whole thing was dodgy from the start. Fortunately my father can't remember any of that.
I also think, if you're a clinic working with a population of people with Alzheimer's, and you know that in general they, and in specific my father, cannot remember having met people before - why would you not introduce yourself at the start of each visit? Why would you not think about the layout and decoration of the clinic and whether it weirds people with Alzheimer's out? In some ways it's a small thing but helps to make me feel how uncaring the research system is, or at least this bit of it that we see, and how little this arm of it appears to know about the needs of people with dementia. It is also pretty intrusive in the detail they need about us both. If it weren't for my father consistently saying that involvement in the research process is the only thing making his life worthwhile, I'd love to get us both out of it.
My father's been reading The Fragile Brain: The strange, hopeful science of dementia by Kathleen Taylor, which talks about the amyloid hypothesis, and from my relatively brief read of some sections of it I'd say it is reasonably accessible to lay people. It's from 2016 though and I expect (hope?) that the science has moved on.
posted by paduasoy at 5:37 PM on July 31, 2021 [5 favorites]
I also think, if you're a clinic working with a population of people with Alzheimer's, and you know that in general they, and in specific my father, cannot remember having met people before - why would you not introduce yourself at the start of each visit? Why would you not think about the layout and decoration of the clinic and whether it weirds people with Alzheimer's out? In some ways it's a small thing but helps to make me feel how uncaring the research system is, or at least this bit of it that we see, and how little this arm of it appears to know about the needs of people with dementia. It is also pretty intrusive in the detail they need about us both. If it weren't for my father consistently saying that involvement in the research process is the only thing making his life worthwhile, I'd love to get us both out of it.
My father's been reading The Fragile Brain: The strange, hopeful science of dementia by Kathleen Taylor, which talks about the amyloid hypothesis, and from my relatively brief read of some sections of it I'd say it is reasonably accessible to lay people. It's from 2016 though and I expect (hope?) that the science has moved on.
posted by paduasoy at 5:37 PM on July 31, 2021 [5 favorites]
This is exactly why physicians need to remain independent professionals and not cogs in a machine that rubber stamp whatever it is their patients saw on TV that they want prescribed so they can stick to their 4 patients-an-hour schedule which keeps hospitals, pharma, and insurance companies happy and rich.
It's funny to me how consistently doctors lay the blame for the overprescribing/misprescribing problem all-but-entirely at the feet of patients "demanding" the latest trendy drug that they "saw on TV." "Hospitals, pharma, and insurance companies" also play a small role, but never is it the case that a doctor freely and independently prescribes a drug that isn't called for, or which is more harmful than helpful.
posted by cinchona at 6:12 PM on July 31, 2021 [2 favorites]
It's funny to me how consistently doctors lay the blame for the overprescribing/misprescribing problem all-but-entirely at the feet of patients "demanding" the latest trendy drug that they "saw on TV." "Hospitals, pharma, and insurance companies" also play a small role, but never is it the case that a doctor freely and independently prescribes a drug that isn't called for, or which is more harmful than helpful.
posted by cinchona at 6:12 PM on July 31, 2021 [2 favorites]
And I mean, nothing we're going to get out of the data they're going to collect in postmarketing really merits the name "clinical trial." There's not going to be a placebo group. They had their chance to do real clinical research already. It showed no promise on the clinically relevant endpoint, only on the amyloid surrogate. You can make real mistakes that way, if the surrogate is not actually in the causal path of the disease, but only a secondary effect of the same cause.
I think there are some structural problems at play here, honestly. If the amyloid cascade hypothesis is right, it takes a decade or two after amyloid begins to accumulate for cognitive change to happen. I imagine this melds poorly with patent lifespans. So, we fall back on a surrogate, which we can see change in faster. I understand the logistics on their end. I understand the pain on the patient end. But on the science end I just don't see any good coming of this.
posted by eirias at 6:13 PM on July 31, 2021 [1 favorite]
I think there are some structural problems at play here, honestly. If the amyloid cascade hypothesis is right, it takes a decade or two after amyloid begins to accumulate for cognitive change to happen. I imagine this melds poorly with patent lifespans. So, we fall back on a surrogate, which we can see change in faster. I understand the logistics on their end. I understand the pain on the patient end. But on the science end I just don't see any good coming of this.
posted by eirias at 6:13 PM on July 31, 2021 [1 favorite]
When FDA advisers are resigning over a drug being approved it's kind of a bad sign.
posted by johnabbe at 8:31 PM on July 31, 2021 [6 favorites]
posted by johnabbe at 8:31 PM on July 31, 2021 [6 favorites]
The FDA approval for this is a disgrace, but that's been said.
Biogen once sued my company because we had a similar name (it had the letter string 'biogen' in it).
posted by porpoise at 10:36 PM on July 31, 2021
Biogen once sued my company because we had a similar name (it had the letter string 'biogen' in it).
posted by porpoise at 10:36 PM on July 31, 2021
I’m an oncologist. From time to time, because my office offers infusion facilities, I am asked to administer drugs for patients that do not have cancer or blood disorders, because some of the medications that I use have other non-oncologic indications (think rituximab for people with severe RA or lupus). I am bracing myself for whether I will be asked to administer this because we have infusion facilities, even though this is a medication that I am beyond dismayed that it is going to be commercially available.
posted by honeybee413 at 5:15 PM on August 2, 2021
posted by honeybee413 at 5:15 PM on August 2, 2021
pretty sure Aducanumab is one of the Old Gods
It’s also my least favorite Genesis album
posted by panama joe at 8:30 PM on August 2, 2021 [2 favorites]
It’s also my least favorite Genesis album
posted by panama joe at 8:30 PM on August 2, 2021 [2 favorites]
The Institute for Clinical and Economic Review has released their final report on aducanumab. It's a 157 page doozy, but some key points from the executive summary:
- evidence rating Insufficient to show benefit
- cost-effectiveness analysis (i.e. what the break-even price would be assuming the drug does what the company says it does): $3000-$8400 --> the list price of $56k is an 18x markup
- Medicare only has enough money to pay for treatment for 35k-36k people over 5 years before Medicare goes bankrupt from this drug
Also of note: the FDA has requested that Biogen conduct a Phase IV confirmatory trial for the next nine years after which they will decide whether or not the drug works. Conveniently, Biogen's patent on Aduhelm expires in ... 2028. So they can sell on patent at their obscene markup, and then as soon as the drug goes off-patent, oopsies, the futility analysis was right all along, the drug doesn't help after all!
posted by basalganglia at 5:00 PM on August 5, 2021 [6 favorites]
- evidence rating Insufficient to show benefit
- cost-effectiveness analysis (i.e. what the break-even price would be assuming the drug does what the company says it does): $3000-$8400 --> the list price of $56k is an 18x markup
- Medicare only has enough money to pay for treatment for 35k-36k people over 5 years before Medicare goes bankrupt from this drug
Also of note: the FDA has requested that Biogen conduct a Phase IV confirmatory trial for the next nine years after which they will decide whether or not the drug works. Conveniently, Biogen's patent on Aduhelm expires in ... 2028. So they can sell on patent at their obscene markup, and then as soon as the drug goes off-patent, oopsies, the futility analysis was right all along, the drug doesn't help after all!
posted by basalganglia at 5:00 PM on August 5, 2021 [6 favorites]
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posted by lalochezia at 3:51 PM on July 30, 2021 [1 favorite]