3 ms·

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

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.
- pwthornton 5y ago
  The biggest harm is going to be people getting side effects with no benefits. I suppose you could argue that Alzheimer's is so bad that who cares about bad side effects, but usually you would not want a drug on the market with no real benefit and a bunch of potential side effects sitting out there.
- mcguire 5y ago
  "What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?" Let's say it is approved, with all pertinent disclaimers. And that it has no side effects (which seems unlikely). With little evidence of effectiveness, insurance, public or private, will not pay for it. They have every right, and at least a fiduciary responsibility not to. But you are desperate, and you are willing to pay $130/day for the drug. What happens if it doesn't work? (As you say, the list of things that don't work is extensive.) Are you going to post on the net, "Our mother's medication didn't work and literally bankrupted us, but it's our fault"?

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.
pwthornton 5y ago
The biggest harm is going to be people getting side effects with no benefits. I suppose you could argue that Alzheimer's is so bad that who cares about bad side effects, but usually you would not want a drug on the market with no real benefit and a bunch of potential side effects sitting out there.
mcguire 5y ago
"What could be benefited by not approving it with all the pertinent disclaimers about effectiveness?" Let's say it is approved, with all pertinent disclaimers. And that it has no side effects (which seems unlikely). With little evidence of effectiveness, insurance, public or private, will not pay for it. They have every right, and at least a fiduciary responsibility not to. But you are desperate, and you are willing to pay $130/day for the drug. What happens if it doesn't work? (As you say, the list of things that don't work is extensive.) Are you going to post on the net, "Our mother's medication didn't work and literally bankrupted us, but it's our fault"?