6 ms·

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 wh

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.
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- 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.
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  - shadowgovt 5y ago
    Are Medicare or Medicaid covering Aduhelm to treat Alzheimer's? I don't know how the flow goes from FDA approval to certification for use by the government-administered insurance programs.
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    - mcguire 5y ago
      That would be Biogen's next step, politically speaking: use public pressure ("They're preventing us from getting a drug that might help!") to force Medicare to cover it.
  - selectodude 5y ago
    I hope you can find peace. I’ve been in your situation and I understand the desperate hope for anything at all that has even a chance of working. Be well.
    - saas_sam 5y ago
      Thank you <3
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  - danso 5y ago
    Sorry, but how does the fact that the government pays for your mother's healthcare make your position more defensible? > 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"? You're implying that "some government worker" is too incompetent to have the power to regulate experimental drugs. And now you're arguing that it'd be cool for those same government workers to rubber stamp approve and also pay for drugs that don't have the backing of scientific evidence, which is the textbook archetype of "incompetent government worker". Not that your hypothetical question makes any sense. "TJ" selling fentanyl down the block is illegal. Biogen selling this unapproved drug is illegal. You have the same ability and legal issues to try to buy from them.
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markus92 5y ago
And that's exactly why it should not be approved. There is no proof there is ANY effect on the disease outcome. The trial was halted prematurely for futility ffs! And now the FDA is giving people false hope? Letting them spend $65k/year for possible snake oil with no scientific evidence behind it? Alzheimer's is a terrible disease. And I get it, you're willing to try anything for a possible improvement. Problem is, there is no proof at all that aducanumab leads to any kind of improvement: only stuff that you might find if you do tons of data mining to get the result you want. If the drug was that good, you would find it each and every time you try it, not one out of a hundred times if you look at a subset of a subset. The only reason the Biogen wants approval of this drug, is to earn money out of desperate people willing to try anything. The FDA should be there to protect people from this. They have failed to do that here.
- saas_sam 5y ago
  If you are against desperate people buying drugs to solve their problems and as such the government should work to keep drugs away from people... tell me, are you an avid supporter of the War on Drugs as well? I hope I don't see any comments by markus92 on future threads advocating for drug legalization, or an easing of restrictions on recreational drugs, or an easing of punishments for drug abuse. Because to say that I don't have the right to try a drug after careful consideration with medical professionals -- DOCTORS -- to potentially help alleviate my dying mother's illness... while any junkie on the street is entitled to getting high on whatever pharmaceutical they can get their hands on. Is morally repugnant.
- bitshiftfaced 5y ago
  The FDA doesn't prevent people from taking herbal supplements, given the supplement doesn't make misleading claims. Assuming this drug doesn't make misleading claims about the evidence for its effectiveness, why should the FDA prevent its sale?
  - danso 5y ago
    Herbal supplements aren't considered drugs by the FDA, and thus are regulated under a different set of rules. What you asked makes as much sense as, "Why won't my doctor prescribe me a breakfast of steak and eggs?"
bjornjajayaja 5y ago
Sorry to hear that about your close family/friends. However, vouching for a rushed approval based on emotions is why such panels exist. That quality assurance is extremely important, especially with respect to drugs. Keep in mind the worst case scenario: the drug does not work, the drug causes adverse side effects, AND it costs money.
danparsonson 5y ago
I'm so sorry for your struggles and those of your family - Alzheimer's is a terrible disease and I too want to see it treatable as soon as possible, but in this case, if the data is inconclusive, then the drug is not actually a treatment for the disease, that's the point. The purpose of all the trials and tests is to ensure that a) the drug actually does what the scientists in the cutting-edge labs think it does, and b) that it's safe or at least has manageable side-effects. I have a relative with this disease so I understand the drive to find a cure but it helps no-one to push through a drug that may end up causing more damage.
- allie1 5y ago
  What could be benefited by not approving it with all the pertinent disclaimers about effectiveness? And to turn it around, what harm would it cause society if it’s not approved due to inconclusive evidence and helps only some people? (Assuming no hard side effects) Keep in mind, there are already ineffective treatments that sell hope and don’t help.
  - acdha 5y ago
    The drug has significant side effects, likely with more to be recognized in wider use — especially in combination with other people. There is a massive cost, which will be paid directly by patients (creating financial stress & conflicting with other care needs) and indirectly by insurance providers who will cut corners and raise costs for everyone. There is a psychological cost to telling people to take on all of the previous costs for something you know won’t have any benefit. Offering false hope isn’t a kindness.
  - danparsonson 5y ago
    Caveat: I'm not medically or pharmaceutically qualified > What could be benefited by not approving it with all the pertinent disclaimers about effectiveness? It prevents the drug being prescribed (at great cost!) to people who are desperate to try anything. What would be the benefit of approving such a drug? Who is missing out by not being able to take a drug not known to be effective? I would consider it malpractice to be prescribed something not demonstrated to have a measurable positive effect. The human body is vastly complicated - we shouldn't mess with it without good reason. > And to turn it around, what harm would it cause society if it’s not approved due to inconclusive evidence and helps only some people? (Assuming no hard side effects) If it's not approved, then I would argue no harm comes to society. What harm is done if a drug that wasn't available before, still is not? Nothing has changed. > Keep in mind, there are already ineffective treatments that sell hope and don’t help. Absolutely, and they are, in my opinion, a work of evil. But the crucial difference is that such treatments (I'm assuming you're referring to quackery such as homeopathy) contain no active ingredient. That's why they aren't regulated. They can't cause medical harm because they don't do anything.

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]
- shadowgovt 5y ago
  Are Medicare or Medicaid covering Aduhelm to treat Alzheimer's? I don't know how the flow goes from FDA approval to certification for use by the government-administered insurance programs.
  - deleted 5y ago
    [deleted]
  - mcguire 5y ago
    That would be Biogen's next step, politically speaking: use public pressure ("They're preventing us from getting a drug that might help!") to force Medicare to cover it.
- selectodude 5y ago
  I hope you can find peace. I’ve been in your situation and I understand the desperate hope for anything at all that has even a chance of working. Be well.
  - saas_sam 5y ago
    Thank you <3
- deleted 5y ago
  [deleted]
- danso 5y ago
  Sorry, but how does the fact that the government pays for your mother's healthcare make your position more defensible? > 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"? You're implying that "some government worker" is too incompetent to have the power to regulate experimental drugs. And now you're arguing that it'd be cool for those same government workers to rubber stamp approve and also pay for drugs that don't have the backing of scientific evidence, which is the textbook archetype of "incompetent government worker". Not that your hypothetical question makes any sense. "TJ" selling fentanyl down the block is illegal. Biogen selling this unapproved drug is illegal. You have the same ability and legal issues to try to buy from them.

deleted 5y ago

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markus92 5y ago

And that's exactly why it should not be approved. There is no proof there is ANY effect on the disease outcome. The trial was halted prematurely for futility ffs! And now the FDA is giving people false hope? Letting them spend $65k/year for possible snake oil with no scientific evidence behind it? Alzheimer's is a terrible disease. And I get it, you're willing to try anything for a possible improvement. Problem is, there is no proof at all that aducanumab leads to any kind of improvement: only stuff that you might find if you do tons of data mining to get the result you want. If the drug was that good, you would find it each and every time you try it, not one out of a hundred times if you look at a subset of a subset. The only reason the Biogen wants approval of this drug, is to earn money out of desperate people willing to try anything. The FDA should be there to protect people from this. They have failed to do that here.

saas_sam 5y ago
If you are against desperate people buying drugs to solve their problems and as such the government should work to keep drugs away from people... tell me, are you an avid supporter of the War on Drugs as well? I hope I don't see any comments by markus92 on future threads advocating for drug legalization, or an easing of restrictions on recreational drugs, or an easing of punishments for drug abuse. Because to say that I don't have the right to try a drug after careful consideration with medical professionals -- DOCTORS -- to potentially help alleviate my dying mother's illness... while any junkie on the street is entitled to getting high on whatever pharmaceutical they can get their hands on. Is morally repugnant.
bitshiftfaced 5y ago
The FDA doesn't prevent people from taking herbal supplements, given the supplement doesn't make misleading claims. Assuming this drug doesn't make misleading claims about the evidence for its effectiveness, why should the FDA prevent its sale?
- danso 5y ago
  Herbal supplements aren't considered drugs by the FDA, and thus are regulated under a different set of rules. What you asked makes as much sense as, "Why won't my doctor prescribe me a breakfast of steak and eggs?"

bjornjajayaja 5y ago

Sorry to hear that about your close family/friends. However, vouching for a rushed approval based on emotions is why such panels exist. That quality assurance is extremely important, especially with respect to drugs. Keep in mind the worst case scenario: the drug does not work, the drug causes adverse side effects, AND it costs money.

danparsonson 5y ago

I'm so sorry for your struggles and those of your family - Alzheimer's is a terrible disease and I too want to see it treatable as soon as possible, but in this case, if the data is inconclusive, then the drug is not actually a treatment for the disease, that's the point. The purpose of all the trials and tests is to ensure that a) the drug actually does what the scientists in the cutting-edge labs think it does, and b) that it's safe or at least has manageable side-effects. I have a relative with this disease so I understand the drive to find a cure but it helps no-one to push through a drug that may end up causing more damage.

allie1 5y ago
What could be benefited by not approving it with all the pertinent disclaimers about effectiveness? And to turn it around, what harm would it cause society if it’s not approved due to inconclusive evidence and helps only some people? (Assuming no hard side effects) Keep in mind, there are already ineffective treatments that sell hope and don’t help.
- acdha 5y ago
  The drug has significant side effects, likely with more to be recognized in wider use — especially in combination with other people. There is a massive cost, which will be paid directly by patients (creating financial stress & conflicting with other care needs) and indirectly by insurance providers who will cut corners and raise costs for everyone. There is a psychological cost to telling people to take on all of the previous costs for something you know won’t have any benefit. Offering false hope isn’t a kindness.
- danparsonson 5y ago
  Caveat: I'm not medically or pharmaceutically qualified > What could be benefited by not approving it with all the pertinent disclaimers about effectiveness? It prevents the drug being prescribed (at great cost!) to people who are desperate to try anything. What would be the benefit of approving such a drug? Who is missing out by not being able to take a drug not known to be effective? I would consider it malpractice to be prescribed something not demonstrated to have a measurable positive effect. The human body is vastly complicated - we shouldn't mess with it without good reason. > And to turn it around, what harm would it cause society if it’s not approved due to inconclusive evidence and helps only some people? (Assuming no hard side effects) If it's not approved, then I would argue no harm comes to society. What harm is done if a drug that wasn't available before, still is not? Nothing has changed. > Keep in mind, there are already ineffective treatments that sell hope and don’t help. Absolutely, and they are, in my opinion, a work of evil. But the crucial difference is that such treatments (I'm assuming you're referring to quackery such as homeopathy) contain no active ingredient. That's why they aren't regulated. They can't cause medical harm because they don't do anything.