24 ms·

> The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effecti

> 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. A near-unanimous vote against the drug, and the FDA moved forward with approval anyway? Like many others, I've experienced first-hand what Alzheimer's does to a person and the hopelessness in fighting it. Approving a drug that doesn't appear to do what it claims to do will provide false hope, and that's the worst thing you can give someone with Alzheimer's.

walugipnts 5y ago
it’s also $56k per year, not including the imaging required
- vxNsr 5y ago
  It doesn’t, that was the suggested price. For anyone who is a candidate for this drug they will almost certainly be on Medicare or Medicaid and the gov negotiates a much lower price than retail.
  - s1artibartfast 5y ago
    This not correct. Medicare does not negotiate any drug prices and is explicitly banned from doing so. Instead medicaid pays the average price paid by private insurance, plus a flat markup % to the doctors office. https://medium.com/unraveling-healthcare/how-do-medicaid-and-medicare-set-drug-prices-83411811d632 https://medium.com/unraveling-healthcare/how-do-medicaid-and... The EU is different in that the national health services negotiate with companies based on patient benefit. This is illegal in USA
    - vxNsr 5y ago
      The article you link directly contradicts your claim: > So how do Medicaid and Medicare set drug prices? Medicaid takes the lowest negotiated price by private payers. After which, states have the right to further negotiate price. Aetna, Express Scripts, and Oscar Insurance all negotiate with pharma companies for the best price. Perhaps Aetna and Oscar only receive 20% discounts while Express Scripts receives a 30% discount. This 30% discounted price is now the Medicaid price. Additional requirements ensure this price level adjusts to inflation. Although the federal government helps fund Medicaid, it’s managed at the state level. At the state level, Medicaid can indeed negotiate further discounts with pharmaceutical companies. However, the federal government is still prohibited. While the fed might not be allowed to negotiate, states can and do. As can individual providers. Basically you’re making a bad faith argument and hoping I wouldn’t read your “source” Also Medicaid and Medicare are two different programs. The reason it doesn’t get too involved in Medicaid is bec it’s a state controlled program and would appear to be outside of their purview. EDIT:: I seem to be getting rate limited by HN due to downvotes so I’m gonna post my reply here: That’s false. Again, the amount paid is never the MSRP, not by Medicare and not by Medicaid. And generally not by any insurance company either. You’re intentionally making a bad faith argument. Both Medicare and Medicaid use negotiated pricing whether they negotiated those prices or someone else did. It is absolutely categorically false to state unequivocally or even imply that Medicare pays the MSRP. In the context of this discussion it is totally false to claim that any medical insurance provider (public or private) will be paying $56k for this drug. Not only because insurance companies don’t pay MSRP, but also because that price was set before all this happened, under these new circumstances BioGen will absolutely be updating their MSRP as well to reflect the new reality (drug is only proven to lower an Alzheimer’s marker and not directly treat the disease itself).
      - s1artibartfast 5y ago
        The part you quoted is specific to Medicaid, and what I said is accurate for Medicare. The greater point also stands, which is that the fed doesnt negotiate prices, and is not lower than retail. >Medicare or Medicaid and the gov negotiates a much lower price than retail
      - s1artibartfast 5y ago
        Follow up: I agree msrp is rarely paid. Even the uninsured can often get manufacturers discount. You raise a good point that there is a possibility that biogen will update msrp, but I wouldn't hold my breath.
jsnell 5y ago
It sounds outrageous when phrased like that. But turns out there's ways of describing what happened that make it sound like a completely reasonable decision as well. See e.g. this forum post: https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fda/152408/2 https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fd... Which of the two groups of experts is right? I certainly don't have the experience to tell. But it seems plausible that both are acting in good faith, and there is no need for outrage.
- entee 5y ago
  That linked post is fundamentally wrong because it rests on an assumption that has essentially zero human evidence: amyloid causes Alzheimer’s. There have been several drugs that very efficiently reduce amyloid, strictly zero (including this one) have ever shown any benefit patient health even when running long trials (the Biogen trials started in 2015 and were halted for futility). There’s reason to believe the amyloid hypothesis is flawed, meaning that approving a drug that reduce amyloid is not going to help anyone, and will likely hurt people (through side effects). If competing experts are the question, note that 3 actual experts have resigned from what are coveted positions in protest. Nearly every part of the pharma industry (including the press, investors, other companies) who doesn’t stand to profit (I.e. not Biogen) has been up in arms saying this is an awful decision using words such as “horrifying”. There is no expert disagreement. People can try to ret-con this by saying it’s like HIV, but note that viral load is a pretty good marker for disease morbidity in most viral infections. Amyloid is nothing like that as a validated marker for disease burden. Useful sources: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3title https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl... https://endpts.com/what-does-a-clear-majority-of-the-biopharma-industry-think-of-the-fda-approval-of-aducanumab-horrifying-dangerous-confusing-disaster/ https://endpts.com/what-does-a-clear-majority-of-the-biophar...
  - abadaba 5y ago
    The author of that post (magnet) mentions the amyloid debate later in that same thread. https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fda/152408/8 https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fd...
saas_sam 5y ago
I'm close to multiple people with Alzheimer's. I think the worst thing you can give them is nothing as their personality evaporates and they become a husk of who they once were and a burden on everyone around them. I can walk 5 minutes down the block and buy an eight ball of fentanyl from a guy named TJ but I can't get Alzheimer's treatment made by a team of scientists in a cutting-edge lab because it doesn't meet some government worker's idea of "good enough"? I don't care what your bureaucratic panel thinks about how inconclusive the data is. My mother is dying.
- seattle_spring 5y ago
  > I can walk 5 minutes down the block and buy an eight ball of fentanyl from a guy named TJ I think TJ might be yanking your chain. "An eight ball" refers explicitly to 1/8 ounce of cocaine. There would be approximately 35,000 doses of fentanyl in an eighth of the stuff.
- selectodude 5y ago
  And charging your mother $90,000 for a drug that does nothing at all isn’t a fix.
  - deleted 5y ago
    [deleted]
    - deleted 5y ago
      [deleted]
  - saas_sam 5y ago
    Mom's on social security she doesn't hasn't paid for any medical procedure in years. Have you heard of Medicare? Medicaid? You don't know what you're talking about at all selectodude.
    - deleted 5y ago
      [deleted]
    - 5y ago
thesausageking 5y ago
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
savant_penguin 5y ago
It really depends. I think that not being able to access a drug because the FDA cites inconclusive research could also be terrible. Obviously you'd have to balance the risks of side effects with the chances of effectiveness. But for a drug with really rare and mild side effects by all means you should be able to try it if you want to without becoming a criminal
- steve76 5y ago
  I want to burn drug dealers at the stake. By all means, I should be able to try that without becoming a criminal.
- JoshTriplett 5y ago
  It's entirely self-consistent to believe that the FDA shouldn't be a gatekeeper over what people can try, and also belive that as long as they maintain that gatekeeper role and don't just approve everything non-toxic then it's harmful for them to approve one specific drug that has no effect. If they purport to be a trusted signal of what works and what doesn't, then their approval is an endorsement, and in this case that endorsement is passing off noise as signal.
- linuxftw 5y ago
  Do you feel the same about access to HCQ and Ivermectin?
  - gilbetron 5y ago
    No the OP, but if they were the only things around that showed any possibility of combating Covid, sure. But that's not the case. We have vaccines and other therapeutics that show incredible effectiveness. Approving HCQ and Ivermectin in this situation is wrong.
    - black6 5y ago
      HCQ and ivermectin efficacy agaist SARS-CoV-2 was suppressed early on. If there were existing effective therapeutics, then emergency use authorization for the vaccines would not have been legally permissible (in the US).
dantheman 5y ago
We shouldn't tie approval to effectiveness, it should only be about harm. Effectiveness claims can be verified through other approaches.
- Tostino 5y ago
  Why should my insurance premiums go up to pay for people getting ineffective treatments? These drugs aren't exactly charity, at $56k/year that's a good chunk of change for something not proven to work.
  - wallacoloo 5y ago
    Excellent point: why should your insurance have to cover every FDA-approved drug, and regardless of cost? My guess is your insurance doesn’t cover every approved treatment. But if it does, is that a problem with the FDA (which regulates drugs), or with your insurance policy (which decides how to pay for them)? I’d suggest your complaints about insurance costs are more closely tied to the latter.
    - HWR_14 5y ago
      > why should your insurance have to cover every FDA-approved drug, and regardless of cost? If only there was some group of experts that decided that some drugs were safe and effective vs. not. We could even make it a nonprofit group to avoid conflicts. Heck, we could get the federal government to fund and and even pass a law that gave their recommendations teeth.
      - dantheman 5y ago
        Just remember the FDA denies people who are dying the ability to choose their treatment.
        HWR_14 5y ago
        No, the FDA doesn't deny people who are dying the ability to choose their treatment. What nonsense is this? There used to be requirements to document the treatment, but even that went away. Or do you mean in the cases where there are already treatments? Because, yes, then take medicine not Dr. Mike's Magic Tonic.
paulpauper 5y ago
Worse than that. A drain on public resources for something that does not work. This drug is very expensive.
birdyrooster 5y ago
They moved forward with a different type of approval specifically meant to mitigate the false hope you are speaking of. I don't see the mutual exclusivity here.

walugipnts 5y ago

it’s also $56k per year, not including the imaging required

vxNsr 5y ago
It doesn’t, that was the suggested price. For anyone who is a candidate for this drug they will almost certainly be on Medicare or Medicaid and the gov negotiates a much lower price than retail.
- s1artibartfast 5y ago
  This not correct. Medicare does not negotiate any drug prices and is explicitly banned from doing so. Instead medicaid pays the average price paid by private insurance, plus a flat markup % to the doctors office. https://medium.com/unraveling-healthcare/how-do-medicaid-and-medicare-set-drug-prices-83411811d632 https://medium.com/unraveling-healthcare/how-do-medicaid-and... The EU is different in that the national health services negotiate with companies based on patient benefit. This is illegal in USA
  - vxNsr 5y ago
    The article you link directly contradicts your claim: > So how do Medicaid and Medicare set drug prices? Medicaid takes the lowest negotiated price by private payers. After which, states have the right to further negotiate price. Aetna, Express Scripts, and Oscar Insurance all negotiate with pharma companies for the best price. Perhaps Aetna and Oscar only receive 20% discounts while Express Scripts receives a 30% discount. This 30% discounted price is now the Medicaid price. Additional requirements ensure this price level adjusts to inflation. Although the federal government helps fund Medicaid, it’s managed at the state level. At the state level, Medicaid can indeed negotiate further discounts with pharmaceutical companies. However, the federal government is still prohibited. While the fed might not be allowed to negotiate, states can and do. As can individual providers. Basically you’re making a bad faith argument and hoping I wouldn’t read your “source” Also Medicaid and Medicare are two different programs. The reason it doesn’t get too involved in Medicaid is bec it’s a state controlled program and would appear to be outside of their purview. EDIT:: I seem to be getting rate limited by HN due to downvotes so I’m gonna post my reply here: That’s false. Again, the amount paid is never the MSRP, not by Medicare and not by Medicaid. And generally not by any insurance company either. You’re intentionally making a bad faith argument. Both Medicare and Medicaid use negotiated pricing whether they negotiated those prices or someone else did. It is absolutely categorically false to state unequivocally or even imply that Medicare pays the MSRP. In the context of this discussion it is totally false to claim that any medical insurance provider (public or private) will be paying $56k for this drug. Not only because insurance companies don’t pay MSRP, but also because that price was set before all this happened, under these new circumstances BioGen will absolutely be updating their MSRP as well to reflect the new reality (drug is only proven to lower an Alzheimer’s marker and not directly treat the disease itself).
    - s1artibartfast 5y ago
      The part you quoted is specific to Medicaid, and what I said is accurate for Medicare. The greater point also stands, which is that the fed doesnt negotiate prices, and is not lower than retail. >Medicare or Medicaid and the gov negotiates a much lower price than retail
    - s1artibartfast 5y ago
      Follow up: I agree msrp is rarely paid. Even the uninsured can often get manufacturers discount. You raise a good point that there is a possibility that biogen will update msrp, but I wouldn't hold my breath.

jsnell 5y ago

It sounds outrageous when phrased like that. But turns out there's ways of describing what happened that make it sound like a completely reasonable decision as well. See e.g. this forum post: https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fda/152408/2 https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fd... Which of the two groups of experts is right? I certainly don't have the experience to tell. But it seems plausible that both are acting in good faith, and there is no need for outrage.

entee 5y ago
That linked post is fundamentally wrong because it rests on an assumption that has essentially zero human evidence: amyloid causes Alzheimer’s. There have been several drugs that very efficiently reduce amyloid, strictly zero (including this one) have ever shown any benefit patient health even when running long trials (the Biogen trials started in 2015 and were halted for futility). There’s reason to believe the amyloid hypothesis is flawed, meaning that approving a drug that reduce amyloid is not going to help anyone, and will likely hurt people (through side effects). If competing experts are the question, note that 3 actual experts have resigned from what are coveted positions in protest. Nearly every part of the pharma industry (including the press, investors, other companies) who doesn’t stand to profit (I.e. not Biogen) has been up in arms saying this is an awful decision using words such as “horrifying”. There is no expert disagreement. People can try to ret-con this by saying it’s like HIV, but note that viral load is a pretty good marker for disease morbidity in most viral infections. Amyloid is nothing like that as a validated marker for disease burden. Useful sources: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3title https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl... https://endpts.com/what-does-a-clear-majority-of-the-biopharma-industry-think-of-the-fda-approval-of-aducanumab-horrifying-dangerous-confusing-disaster/ https://endpts.com/what-does-a-clear-majority-of-the-biophar...
- abadaba 5y ago
  The author of that post (magnet) mentions the amyloid debate later in that same thread. https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fda/152408/8 https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fd...

saas_sam 5y ago

I'm close to multiple people with Alzheimer's. I think the worst thing you can give them is nothing as their personality evaporates and they become a husk of who they once were and a burden on everyone around them. I can walk 5 minutes down the block and buy an eight ball of fentanyl from a guy named TJ but I can't get Alzheimer's treatment made by a team of scientists in a cutting-edge lab because it doesn't meet some government worker's idea of "good enough"? I don't care what your bureaucratic panel thinks about how inconclusive the data is. My mother is dying.

seattle_spring 5y ago
> I can walk 5 minutes down the block and buy an eight ball of fentanyl from a guy named TJ I think TJ might be yanking your chain. "An eight ball" refers explicitly to 1/8 ounce of cocaine. There would be approximately 35,000 doses of fentanyl in an eighth of the stuff.
selectodude 5y ago
And charging your mother $90,000 for a drug that does nothing at all isn’t a fix.
- deleted 5y ago
  [deleted]
  - deleted 5y ago
    [deleted]
- saas_sam 5y ago
  Mom's on social security she doesn't hasn't paid for any medical procedure in years. Have you heard of Medicare? Medicaid? You don't know what you're talking about at all selectodude.
  - deleted 5y ago
    [deleted]
  - 5y ago

thesausageking 5y ago

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

savant_penguin 5y ago

It really depends. I think that not being able to access a drug because the FDA cites inconclusive research could also be terrible. Obviously you'd have to balance the risks of side effects with the chances of effectiveness. But for a drug with really rare and mild side effects by all means you should be able to try it if you want to without becoming a criminal

steve76 5y ago
I want to burn drug dealers at the stake. By all means, I should be able to try that without becoming a criminal.
JoshTriplett 5y ago
It's entirely self-consistent to believe that the FDA shouldn't be a gatekeeper over what people can try, and also belive that as long as they maintain that gatekeeper role and don't just approve everything non-toxic then it's harmful for them to approve one specific drug that has no effect. If they purport to be a trusted signal of what works and what doesn't, then their approval is an endorsement, and in this case that endorsement is passing off noise as signal.
linuxftw 5y ago
Do you feel the same about access to HCQ and Ivermectin?
- gilbetron 5y ago
  No the OP, but if they were the only things around that showed any possibility of combating Covid, sure. But that's not the case. We have vaccines and other therapeutics that show incredible effectiveness. Approving HCQ and Ivermectin in this situation is wrong.
  - black6 5y ago
    HCQ and ivermectin efficacy agaist SARS-CoV-2 was suppressed early on. If there were existing effective therapeutics, then emergency use authorization for the vaccines would not have been legally permissible (in the US).

dantheman 5y ago

We shouldn't tie approval to effectiveness, it should only be about harm. Effectiveness claims can be verified through other approaches.

Tostino 5y ago
Why should my insurance premiums go up to pay for people getting ineffective treatments? These drugs aren't exactly charity, at $56k/year that's a good chunk of change for something not proven to work.
- wallacoloo 5y ago
  Excellent point: why should your insurance have to cover every FDA-approved drug, and regardless of cost? My guess is your insurance doesn’t cover every approved treatment. But if it does, is that a problem with the FDA (which regulates drugs), or with your insurance policy (which decides how to pay for them)? I’d suggest your complaints about insurance costs are more closely tied to the latter.
  - HWR_14 5y ago
    > why should your insurance have to cover every FDA-approved drug, and regardless of cost? If only there was some group of experts that decided that some drugs were safe and effective vs. not. We could even make it a nonprofit group to avoid conflicts. Heck, we could get the federal government to fund and and even pass a law that gave their recommendations teeth.
    - dantheman 5y ago
      Just remember the FDA denies people who are dying the ability to choose their treatment.
      - HWR_14 5y ago
        No, the FDA doesn't deny people who are dying the ability to choose their treatment. What nonsense is this? There used to be requirements to document the treatment, but even that went away. Or do you mean in the cases where there are already treatments? Because, yes, then take medicine not Dr. Mike's Magic Tonic.

paulpauper 5y ago

Worse than that. A drain on public resources for something that does not work. This drug is very expensive.

birdyrooster 5y ago

They moved forward with a different type of approval specifically meant to mitigate the false hope you are speaking of. I don't see the mutual exclusivity here.