6 ms·

The FDA didn't give it a full approval. It was an accelerated approval that basically said "This drug has been shown to help biomarkers that are associated with

The FDA didn't give it a full approval. It was an accelerated approval that basically said "This drug has been shown to help biomarkers that are associated with Alzheimer’s, but it's unknown if it helps with Alzheimer’s itself. While more evidence is collected, Biogen can distribute it." Which is reasonable to me. It takes years to test drugs like this and if a patient and her doctor believe this is the best treatment, the FDA shouldn't prevent them from getting access to it.

bananapub 5y ago
doesn't this translate into a many year long permission to sell a drug with no evidence that it works?
- Arrath 5y ago
  It certainly sounds like it, yes.
- BurningFrog 5y ago
  There is inconclusive evidence that it works. That's in theory a good scenario for allowing some level of use. If this practical level of use is good, I don't know.
  - paulpauper 5y ago
    Given the costs, I don't think this is good enough. Medicare cannot afford to subsidize things are inconclusive especially given how 6 million Americans have Alzheiemrs.
    - mcguire 5y ago
      The $50k/year above times 6 million is $300B. For $300,000,000,000, I suspect no one cares whether it works.
      - CincinnatiMan 5y ago
        What do you mean by this? That sounds like a lot of money and I would think taxpayers would care if such a large amount were to be essentially thrown away.
    - BurningFrog 5y ago
      I think a sane system would be where a drug is legal to use, and Medicare can decide it's not worth paying for. Those should be be independent decisions.
CogitoCogito 5y ago
> Which is reasonable to me. It takes years to test drugs like this and if a patient and her doctor believe this is the best treatment, the FDA shouldn't prevent them from getting access to it. I can understand this argument as long as Biogen isn't making any money off of these drugs. In fact, they should really be losing money if anything since they are gaining value from the data.
- thesausageking 5y ago
  The big question is will insurance companies and CMS pay for it, and that's not up to the FDA. That debate is occurring right now and will likely create new precedents.
- f6v 5y ago
  Big Pharma bad, but making drugs is incredibly costly. Especially in Alzheimers, where so many candidates failed. It's incredible someone is even trying after so many failures.
  - CogitoCogito 5y ago
    That's true, but I don't really see why the drug companies shouldn't pay those costs.
    - alexslobodnik 5y ago
      The second order effects may be that they wouldn't want to even try to develop a drug. What world do you want to live in? (Rhetorical)
      - mcguire 5y ago
        The third order effects may be continued erosion of respect for the federal government's regulatory process. Tread carefully. (And make lots of money while you can.)
        5y ago
shmatt 5y ago
This right here. People move cross country or even internationally for a chance to be in the 1 hospital who is running a trial for some non-proven drug for their disease Being able to get the drug wherever you are in the U.S is a good step, and every patient/doctor can decide if they want to try it
- Alex3917 5y ago
  > Being able to get the drug wherever you are in the U.S is a good step, and every patient/doctor can decide if they want to try it FDA approval is for letting companies market a drug to the public, it has nothing to do with whether you as a patient are allowed to take it.
  - thesausageking 5y ago
    That's incorrect. Biogen can't legally sell you the drug unless it's been approved by the FDA or they use one of the specific exemptions like doing a drug trial.
    - dlp211 5y ago
      Why should Biogen be able to sell their drug? It hasn't been shown to work, it is for all intents and purposes at this point in time, snake oil. Should Biogen be able to continue research and studies, sure, but they shouldn't be able to sell it until they have proof that it actually improves someone's life instead of having some effects on a possible bio-marker.
    - cogman10 5y ago
      That's incorrect. Doctors can (and do) prescribe drugs for off label usages. There's nothing "illegal" about it. The reason they don't do that more commonly is malpractice lawsuits and insurance companies don't like to cover off label prescriptions. An excellent example of this: Medical Marijuana. Not FDA approved for almost anything and the only reason it's "illegal" is because of federal DEA classification. So long as it's not listed as having any therapeutic effects, you can fairly freely buy any non-controlled substance. For example: https://www.amazon.com/Arsenic-99-9999-Crystalline-Metalloid-Collection/dp/B071JR5SP5/ref=sr_1_9?dchild=1&keywords=arsenic&qid=1623437100&sr=8-9 https://www.amazon.com/Arsenic-99-9999-Crystalline-Metalloid...
wyxuan 5y ago
Okay, but Biogen has 9 years to do the confirmatory study and they've indicated that they'll take their sweet, sweet, time with it. Also, it's not like we have 0 evidence: we have two, 4-5 year long studies that show how well it works: and the benefit in one was marginally positive and the effect of aduhelm was negative in the other. Sarepta's Eteplirsen was in a similar situation: little data to back it up and a very controversial decision. They also had to do confirmatory studies, but it took them 3 years after the approval was done for the study to begin.
Bjartr 5y ago
They did test this drug for years, the conclusion was that the drug does absolutely nothing for Alzheimer's. A big part of what FDA approval means is that it's been confirmed that the drug does what the makers of the drug claim it does. If that weren't the case, many drugs that have not been approved over past decades would have been.
mcguire 5y ago
And by "can distribute it", do they mean sell? 'Cause selling something you have no reason to believe is fit for purpose can cause problems. That is, unless a large government agency has you back.
HWR_14 5y ago
> if a patient and her doctor believe this is the best treatment, the FDA shouldn't prevent them from getting access to it. I question whether a patient or her doctor is more qualified to make that call than a panel of experts. But we already allow drug trials - those are just measured. And if there are no other treatments, the FDA has had a compassionate use protocol for a long time to let people attempt anything over nothing.
- treeman79 5y ago
  And if the doctor is getting kickbacks? I was prescribed a very expensive new drug that I couldn’t tolerate. Eliquis, Xarelto. Medical office went to absurd lengths to keep me on it rather then switching to a cheaper alternative. Too multiple ER visits to get them to switch. Kept calling me a liar for saying it had side effects. Realized later that they probably made money off it. Would love to know if true.
  - HWR_14 5y ago
    > Realized later that they probably made money off it. Would love to know if true. They probably didn't even make a lot of money. Although they paid $18.3 million to doctors in 2018, only nine doctors got over $100k. Are you in the US? By law, there has been a public database of all pharama dollars to doctors for a bit over a decade. It covers lunches and consulting fees and such. For 2018, ProPublica has a searchable database. Here's Xarelto's results. Edit: I just realized I forgot to paste in the link. I hope I edit this before you see it: https://projects.propublica.org/docdollars/products/16510 https://projects.propublica.org/docdollars/products/16510
  - mikeodds 5y ago
    One place to search https://projects.propublica.org/docdollars/ https://projects.propublica.org/docdollars/. Disclaimer: not familiar with US medical industry or incentives schemes for docs
- koheripbal 5y ago
  > No need for anyone to wear a mask. -- Many panels of experts in Feb 2020.

bananapub 5y ago

doesn't this translate into a many year long permission to sell a drug with no evidence that it works?

Arrath 5y ago
It certainly sounds like it, yes.
BurningFrog 5y ago
There is inconclusive evidence that it works. That's in theory a good scenario for allowing some level of use. If this practical level of use is good, I don't know.
- paulpauper 5y ago
  Given the costs, I don't think this is good enough. Medicare cannot afford to subsidize things are inconclusive especially given how 6 million Americans have Alzheiemrs.
  - mcguire 5y ago
    The $50k/year above times 6 million is $300B. For $300,000,000,000, I suspect no one cares whether it works.
    - CincinnatiMan 5y ago
      What do you mean by this? That sounds like a lot of money and I would think taxpayers would care if such a large amount were to be essentially thrown away.
  - BurningFrog 5y ago
    I think a sane system would be where a drug is legal to use, and Medicare can decide it's not worth paying for. Those should be be independent decisions.

CogitoCogito 5y ago

> Which is reasonable to me. It takes years to test drugs like this and if a patient and her doctor believe this is the best treatment, the FDA shouldn't prevent them from getting access to it. I can understand this argument as long as Biogen isn't making any money off of these drugs. In fact, they should really be losing money if anything since they are gaining value from the data.

thesausageking 5y ago
The big question is will insurance companies and CMS pay for it, and that's not up to the FDA. That debate is occurring right now and will likely create new precedents.
f6v 5y ago
Big Pharma bad, but making drugs is incredibly costly. Especially in Alzheimers, where so many candidates failed. It's incredible someone is even trying after so many failures.
- CogitoCogito 5y ago
  That's true, but I don't really see why the drug companies shouldn't pay those costs.
  - alexslobodnik 5y ago
    The second order effects may be that they wouldn't want to even try to develop a drug. What world do you want to live in? (Rhetorical)
    - mcguire 5y ago
      The third order effects may be continued erosion of respect for the federal government's regulatory process. Tread carefully. (And make lots of money while you can.)
      - 5y ago

shmatt 5y ago

This right here. People move cross country or even internationally for a chance to be in the 1 hospital who is running a trial for some non-proven drug for their disease Being able to get the drug wherever you are in the U.S is a good step, and every patient/doctor can decide if they want to try it

Alex3917 5y ago
> Being able to get the drug wherever you are in the U.S is a good step, and every patient/doctor can decide if they want to try it FDA approval is for letting companies market a drug to the public, it has nothing to do with whether you as a patient are allowed to take it.
- thesausageking 5y ago
  That's incorrect. Biogen can't legally sell you the drug unless it's been approved by the FDA or they use one of the specific exemptions like doing a drug trial.
  - dlp211 5y ago
    Why should Biogen be able to sell their drug? It hasn't been shown to work, it is for all intents and purposes at this point in time, snake oil. Should Biogen be able to continue research and studies, sure, but they shouldn't be able to sell it until they have proof that it actually improves someone's life instead of having some effects on a possible bio-marker.
  - cogman10 5y ago
    That's incorrect. Doctors can (and do) prescribe drugs for off label usages. There's nothing "illegal" about it. The reason they don't do that more commonly is malpractice lawsuits and insurance companies don't like to cover off label prescriptions. An excellent example of this: Medical Marijuana. Not FDA approved for almost anything and the only reason it's "illegal" is because of federal DEA classification. So long as it's not listed as having any therapeutic effects, you can fairly freely buy any non-controlled substance. For example: https://www.amazon.com/Arsenic-99-9999-Crystalline-Metalloid-Collection/dp/B071JR5SP5/ref=sr_1_9?dchild=1&keywords=arsenic&qid=1623437100&sr=8-9 https://www.amazon.com/Arsenic-99-9999-Crystalline-Metalloid...

wyxuan 5y ago

Okay, but Biogen has 9 years to do the confirmatory study and they've indicated that they'll take their sweet, sweet, time with it. Also, it's not like we have 0 evidence: we have two, 4-5 year long studies that show how well it works: and the benefit in one was marginally positive and the effect of aduhelm was negative in the other. Sarepta's Eteplirsen was in a similar situation: little data to back it up and a very controversial decision. They also had to do confirmatory studies, but it took them 3 years after the approval was done for the study to begin.

Bjartr 5y ago

They did test this drug for years, the conclusion was that the drug does absolutely nothing for Alzheimer's. A big part of what FDA approval means is that it's been confirmed that the drug does what the makers of the drug claim it does. If that weren't the case, many drugs that have not been approved over past decades would have been.

mcguire 5y ago

And by "can distribute it", do they mean sell? 'Cause selling something you have no reason to believe is fit for purpose can cause problems. That is, unless a large government agency has you back.

HWR_14 5y ago

> if a patient and her doctor believe this is the best treatment, the FDA shouldn't prevent them from getting access to it. I question whether a patient or her doctor is more qualified to make that call than a panel of experts. But we already allow drug trials - those are just measured. And if there are no other treatments, the FDA has had a compassionate use protocol for a long time to let people attempt anything over nothing.

treeman79 5y ago
And if the doctor is getting kickbacks? I was prescribed a very expensive new drug that I couldn’t tolerate. Eliquis, Xarelto. Medical office went to absurd lengths to keep me on it rather then switching to a cheaper alternative. Too multiple ER visits to get them to switch. Kept calling me a liar for saying it had side effects. Realized later that they probably made money off it. Would love to know if true.
- HWR_14 5y ago
  > Realized later that they probably made money off it. Would love to know if true. They probably didn't even make a lot of money. Although they paid $18.3 million to doctors in 2018, only nine doctors got over $100k. Are you in the US? By law, there has been a public database of all pharama dollars to doctors for a bit over a decade. It covers lunches and consulting fees and such. For 2018, ProPublica has a searchable database. Here's Xarelto's results. Edit: I just realized I forgot to paste in the link. I hope I edit this before you see it: https://projects.propublica.org/docdollars/products/16510 https://projects.propublica.org/docdollars/products/16510
- mikeodds 5y ago
  One place to search https://projects.propublica.org/docdollars/ https://projects.propublica.org/docdollars/. Disclaimer: not familiar with US medical industry or incentives schemes for docs
koheripbal 5y ago
> No need for anyone to wear a mask. -- Many panels of experts in Feb 2020.