4 ms·

This drug was approved after Phase II trials largely failed and a second review panel was convened to override the first. Now it has failed again in Phase III a

by kurthr 3y ago

This drug was approved after Phase II trials largely failed and a second review panel was convened to override the first. Now it has failed again in Phase III after being given to many hopeful patients at great cost. The last lines rang true: You need what you've always needed: efficacy and safety. Boring, tedious, expensive efficacy and safety. Desire and despair don't figure in much - in a much different universe, one whose physical laws respected and validated human emotions and human suffering, they would. But we don't live in that world.

deleted 3y ago
[deleted]
echelon 3y ago
[flagged]
- jobs_throwaway 3y ago
  On an individual level that's rational, but on an institutional level the safeguards and caution are also rational. If you are able to make the drugs/experiments yourself, knock yourself out. But don't expect huge corporations/governments to do it for you
  - tiahura 3y ago
    Shouldn't the safeguards be inversely proportional to the level of untreatable misery?
    - JumpCrisscross 3y ago
      > Shouldn't the safeguards be inversely proportional to the level of untreatable misery? This is tautology’s Treatment is the variable. What constitutes the untreatable is the point of the question.
  - aeternum 3y ago
    The safeguards and caution are even more immoral from a rationalist point of view. By delaying potential medical breakthroughs you cause many future humans some amount of additional suffering because medical breakthroughs build on one another. If you delay an ALS cure by one year, you are not only harming all those who have ALS for that year but all those present and future humans that have other diseases that could benefit from the future research tree branching out from that ALS cure. Suppose for example that our ancestors were more risk-averse, more focused on the moral "do no harm" and thereby agreed upon 20 year trials for all new surgical procedures. What would 'modern' surgery look like? We should be celebrating the risk-takers as willingness to take an experimental drug or an experimental treatment as it is often a greater gift to humanity than an organ donation.
- thenerdhead 3y ago
  https://www.congress.gov/bill/118th-congress/senate-bill/1906/titles?s=1&r=44 https://www.congress.gov/bill/118th-congress/senate-bill/190...
  - echelon 3y ago
    This is exactly the right direction.
- caslon 3y ago
  There are other countries, ones where it's legal to do medical experimentation upon any consenting party. Unsurprisingly, they don't create significant amounts of novel drugs. Why? Because the US system is more profitable, and, similar to how writing proprietary software is the most common way to earn a living as a software engineer, people like money. Similar to platforms that claim to "democratize" a given hobby while at the end of the day being proprietary SaaS, people can claim as good of motives as they want, but at the end of the day, they want to make enough money to sit on their heels. The government strongly incentivizes drugs that are economically worthless without it. The US system ensures that everyone gets paid. Laissez-faire drug development wouldn't. As better in theory as it may be, just like free software, in practice, you'd probably get fewer returns than the controlled system, just because people aren't altruistic, and nobody cares about niche diseases that doesn't have direct motive.
  - echelon 3y ago
    Not once did I propose changing the economic model. Only that we should give consenting, perhaps eager, terminal patients more options in participating in research and access to promising new drugs. It's unfair that there's a decade of waiting when lives are so quickly and pointlessly lost. You're alive as a conscious participant in the universe just once, and then there's an infinity of nothing. You should have the option to try to keep that spark alive. If a chance, even fleeting, lies behind a glass door, that's cruel.
    - catlikesshrimp 3y ago
      If you did that, there would be a rush of (not necessarily) terminal patients signing up and mostly dieing anyways (hopefully of their terminal illnesses) There would be, as expected, a large contingent of patients who were poor, alone and maybe not very terminal. The very same reason which lead to the creation of ethics committes
- andrewflnr 3y ago
  Sometimes when you get a random stupid downvote, someone else will come along and fix it. I've been on both sides of that. But when you complain about it, that's pretty near a guarantee that I won't touch it. Because the point of downvotes is to suppress useless content, and complaining about how you're being "silenced" because someone downvoted you on a web forum definitely qualifies. You're not entitled to be heard. A forum is a shared space, so it doesn't work unless we all have a vote on what happens here. If you somehow create the universe where people have "complete control", and you say annoying or even boring stuff, you won't get downvoted, you'll just get blackholed. Do you think that'll feel better? Anyway, don't take downvotes so seriously. Some days the hive is just cranky.
  - sillysaurusx 3y ago
    More to the point, I was going to vouch the comment (which removes the flagged status) till I got to the edits. It’s not possible to vouch it in its current state, because at best I’d be making a mistake, and at worst I’d lose my vouch privileges. So you’re literally making it impossible to salvage your comment when you go off on rants about censorship. There are thoughtful ways to comment about the moderation. If you take the time to phrase things in a substantive non-emotional way, and ask yourself "what am I trying to communicate?" you often end up with something that won’t be flagged. But the combination of user flags and manual mod review with the vouch system adding even more variability means that it’s a tossup whether any given decision will be reversed (or even can be reversed, since e.g. this one can’t be). It’s best to think of it like a casino and not worry on the days the cards don’t favor you. Amusingly, the change to rank flagged comments above downvoted comments in an effort to push them to places less-seen has catapulted this subthread to the second top comment of the whole submission, which I haven’t seen before. HN never fails to surprise.
    - andrewflnr 3y ago
      Interesting. It wasn't flagged when I commented. So it got flagged, vouched, and flagged again? I hadn't heard of/seen that ordering change. Also interesting. Though I can't agree with your last line, HN is very predictable sometimes. For instance, any thread about dark matter is reliably a mess. :D
- deleted 3y ago
  [deleted]
thenerdhead 3y ago
How about we fix that with this? https://www.congress.gov/bill/118th-congress/senate-bill/1906/titles?s=1&r=44 https://www.congress.gov/bill/118th-congress/senate-bill/190... Give patients access and do the right science. Make sure it is safe and allow people the right to try.
- capitainenemo 3y ago
  In the case of the parent article drug, it claims it was the pressure of patient advocacy groups that got the drug approved. Giving people the right to try unfortunately at present means everyone else paying for it (or paying for the harm it causes), unless unapproved drugs were required to be covered by the individual on their own. " But ALS patients (or their insurance companies) had the chance to pay for a drug ($158,000/yr list, who knows what the real price was somewhere below that) for what is in the end a combination of two generic medicines. And they might as well have been given peppermint candy for all the good it did. ... patient advocacy groups took victory laps after Relyvrio was approved, and they were a big part of the pressure that made the FDA reverse its initial correct decision "
- peeters 3y ago
  Can you expand on this? This bill seems to enable exactly what the author is attacking: exploiting the desperate hopes of terminally ill patients to sell ineffective drugs. I agree with removing red tape and allowing accelerated trials when the drugs are for these purposes, but it seems like today, drug companies can make a profit off of selling snake oil. They already stand to benefit from the reduced regulations, so why allow them to sell the drug at all under these circumstances? If they're so confident in the efficacy, they should be willing to give the drug away for free to benefit from an accelerated path to approval. This bill seems to allow drug companies to continue to sell under these regulations, and in fact goes even further by removing most liability from them.
  - yieldcrv 3y ago
    > but it seems like today, drug companies can make a profit off of selling snake oil anybody can sell sugar pills or any 'generally approved as safe' consumptive good, repackaged as something big pharma is hiding from you

by kurthr 3y ago

deleted 3y ago

[deleted]

echelon 3y ago

[flagged]

jobs_throwaway 3y ago
On an individual level that's rational, but on an institutional level the safeguards and caution are also rational. If you are able to make the drugs/experiments yourself, knock yourself out. But don't expect huge corporations/governments to do it for you
- tiahura 3y ago
  Shouldn't the safeguards be inversely proportional to the level of untreatable misery?
  - JumpCrisscross 3y ago
    > Shouldn't the safeguards be inversely proportional to the level of untreatable misery? This is tautology’s Treatment is the variable. What constitutes the untreatable is the point of the question.
- aeternum 3y ago
  The safeguards and caution are even more immoral from a rationalist point of view. By delaying potential medical breakthroughs you cause many future humans some amount of additional suffering because medical breakthroughs build on one another. If you delay an ALS cure by one year, you are not only harming all those who have ALS for that year but all those present and future humans that have other diseases that could benefit from the future research tree branching out from that ALS cure. Suppose for example that our ancestors were more risk-averse, more focused on the moral "do no harm" and thereby agreed upon 20 year trials for all new surgical procedures. What would 'modern' surgery look like? We should be celebrating the risk-takers as willingness to take an experimental drug or an experimental treatment as it is often a greater gift to humanity than an organ donation.
thenerdhead 3y ago
https://www.congress.gov/bill/118th-congress/senate-bill/1906/titles?s=1&r=44 https://www.congress.gov/bill/118th-congress/senate-bill/190...
- echelon 3y ago
  This is exactly the right direction.
caslon 3y ago
There are other countries, ones where it's legal to do medical experimentation upon any consenting party. Unsurprisingly, they don't create significant amounts of novel drugs. Why? Because the US system is more profitable, and, similar to how writing proprietary software is the most common way to earn a living as a software engineer, people like money. Similar to platforms that claim to "democratize" a given hobby while at the end of the day being proprietary SaaS, people can claim as good of motives as they want, but at the end of the day, they want to make enough money to sit on their heels. The government strongly incentivizes drugs that are economically worthless without it. The US system ensures that everyone gets paid. Laissez-faire drug development wouldn't. As better in theory as it may be, just like free software, in practice, you'd probably get fewer returns than the controlled system, just because people aren't altruistic, and nobody cares about niche diseases that doesn't have direct motive.
- echelon 3y ago
  Not once did I propose changing the economic model. Only that we should give consenting, perhaps eager, terminal patients more options in participating in research and access to promising new drugs. It's unfair that there's a decade of waiting when lives are so quickly and pointlessly lost. You're alive as a conscious participant in the universe just once, and then there's an infinity of nothing. You should have the option to try to keep that spark alive. If a chance, even fleeting, lies behind a glass door, that's cruel.
  - catlikesshrimp 3y ago
    If you did that, there would be a rush of (not necessarily) terminal patients signing up and mostly dieing anyways (hopefully of their terminal illnesses) There would be, as expected, a large contingent of patients who were poor, alone and maybe not very terminal. The very same reason which lead to the creation of ethics committes
andrewflnr 3y ago
Sometimes when you get a random stupid downvote, someone else will come along and fix it. I've been on both sides of that. But when you complain about it, that's pretty near a guarantee that I won't touch it. Because the point of downvotes is to suppress useless content, and complaining about how you're being "silenced" because someone downvoted you on a web forum definitely qualifies. You're not entitled to be heard. A forum is a shared space, so it doesn't work unless we all have a vote on what happens here. If you somehow create the universe where people have "complete control", and you say annoying or even boring stuff, you won't get downvoted, you'll just get blackholed. Do you think that'll feel better? Anyway, don't take downvotes so seriously. Some days the hive is just cranky.
- sillysaurusx 3y ago
  More to the point, I was going to vouch the comment (which removes the flagged status) till I got to the edits. It’s not possible to vouch it in its current state, because at best I’d be making a mistake, and at worst I’d lose my vouch privileges. So you’re literally making it impossible to salvage your comment when you go off on rants about censorship. There are thoughtful ways to comment about the moderation. If you take the time to phrase things in a substantive non-emotional way, and ask yourself "what am I trying to communicate?" you often end up with something that won’t be flagged. But the combination of user flags and manual mod review with the vouch system adding even more variability means that it’s a tossup whether any given decision will be reversed (or even can be reversed, since e.g. this one can’t be). It’s best to think of it like a casino and not worry on the days the cards don’t favor you. Amusingly, the change to rank flagged comments above downvoted comments in an effort to push them to places less-seen has catapulted this subthread to the second top comment of the whole submission, which I haven’t seen before. HN never fails to surprise.
  - andrewflnr 3y ago
    Interesting. It wasn't flagged when I commented. So it got flagged, vouched, and flagged again? I hadn't heard of/seen that ordering change. Also interesting. Though I can't agree with your last line, HN is very predictable sometimes. For instance, any thread about dark matter is reliably a mess. :D
deleted 3y ago
[deleted]

thenerdhead 3y ago

How about we fix that with this? https://www.congress.gov/bill/118th-congress/senate-bill/1906/titles?s=1&r=44 https://www.congress.gov/bill/118th-congress/senate-bill/190... Give patients access and do the right science. Make sure it is safe and allow people the right to try.

capitainenemo 3y ago
In the case of the parent article drug, it claims it was the pressure of patient advocacy groups that got the drug approved. Giving people the right to try unfortunately at present means everyone else paying for it (or paying for the harm it causes), unless unapproved drugs were required to be covered by the individual on their own. " But ALS patients (or their insurance companies) had the chance to pay for a drug ($158,000/yr list, who knows what the real price was somewhere below that) for what is in the end a combination of two generic medicines. And they might as well have been given peppermint candy for all the good it did. ... patient advocacy groups took victory laps after Relyvrio was approved, and they were a big part of the pressure that made the FDA reverse its initial correct decision "
peeters 3y ago
Can you expand on this? This bill seems to enable exactly what the author is attacking: exploiting the desperate hopes of terminally ill patients to sell ineffective drugs. I agree with removing red tape and allowing accelerated trials when the drugs are for these purposes, but it seems like today, drug companies can make a profit off of selling snake oil. They already stand to benefit from the reduced regulations, so why allow them to sell the drug at all under these circumstances? If they're so confident in the efficacy, they should be willing to give the drug away for free to benefit from an accelerated path to approval. This bill seems to allow drug companies to continue to sell under these regulations, and in fact goes even further by removing most liability from them.
- yieldcrv 3y ago
  > but it seems like today, drug companies can make a profit off of selling snake oil anybody can sell sugar pills or any 'generally approved as safe' consumptive good, repackaged as something big pharma is hiding from you