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The problem is that lay people have essentially no ability to distinguish between potential 'last shots'. And exemptions will invite snake-oil salesmen. It can

by roc 14y ago

The problem is that lay people have essentially no ability to distinguish between potential 'last shots'. And exemptions will invite snake-oil salesmen. It can be frustrating, but the rules weren't created in some blind bureaucratic power-grab. They're responses to actual problems that existed in their absence. They aren't without their downsides, but they remain better than the alternative on balance.

wwwtyro 14y ago
They aren't without their downsides, but they remain better than the alternative on balance. That's not a credible claim. Tell that to either of the two people that left those comments. Sure, there's risks inherent with experimental drugs, but these people are dying or losing loved ones. They don't give a damn, and none of us has any right to stop them from taking those risks with their own persons. Their bodies are their own, they are not yours. And frankly, the snake-oil salesman claim strikes me as little more than FUD. People can get recommendations from multiple MDs before making up their minds.
- rubyrescue 14y ago
  The history of snake-oil salesmen is well documented. http://www.authentichistory.com/1898-1913/2-progressivism/8-quackery/ http://www.authentichistory.com/1898-1913/2-progressivism/8-...
  - wwwtyro 14y ago
    I'm not denying their existence.
  - maxharris 14y ago
    Why is it OK to lump honest physicians, researchers and patients in with snake oil salesmen and their victims? Why is it morally acceptable to have laws intended to help the people that don't care to tell the difference? Those laws come at the expense of those who do care, who take the trouble to figure things out. Why shouldn't we live in a free society where the best within us can make a difference, and take humanity forward?
    - Retric 14y ago
      Why is it OK to lump honest physicians, researchers and patients in with snake oil salesmen and their victims? The best snake oil salesmen believe in their products. There are already exceptions for allowing people to take highly experimental procedures when there likely to die without them. However, there are plenty of cases where highly trained well meaning doctors caused massive suffering without benefit to their direct patents. As a recent example of fringe medicine, a few athletes have injected themselves with stem cells. Not to mention the modern version of doping which often involves substances that are known to be harmful or medicine has little idea what the long term effects are.
      - maxharris 14y ago
        So we should treat every physician, researcher and patient as guilty, incorrect or foolish until proven innocent, correct or wise? However, there are plenty of cases where highly trained well meaning doctors caused massive suffering without benefit to their direct patents. No one is omniscient. The ideal in medicine can't be something impossible (i.e., medicine that cures all ills and everyone, and never has any risks or side effects). No one knows how to do that (now and for the foreseeable future), and we shouldn't deny people the best chance they have at life to chase an impossibility.
        Retric 14y ago
        So we should treat ... researcher... as guilty, incorrect or foolish until proven innocent, correct or wise? Yes, that's the point of peer review.
        maxharris 14y ago
        Peer review is just another thing that helps individuals decide scientific matters for themselves. The implicit idea behind peer review can be summed up like this: "This is what I think about this work. (I have credentials X, Y, and Z, and I've published this stuff you many have heard of.) What I have to say is just another thing for you to consider. Take it or leave it."
- noonespecial 14y ago
  For what its worth, I agree with you, but the other side is not so unreasonable as it seems. The risk is not to the dying. The risk is that selection bias (of the miracle survivors) might cause an ineffectual drug to creep down the chain of "desperateness" (from the truly desperate to the less so) until it possibly occludes treatments that do work.
Symmetry 14y ago
Yet somehow countries that regulate drugs merely by safety tend to produce better health outcomes than countries that regulate for safety and efficacy like the US FDA does. You're just asserting that the upsides outweigh the downsides, but every study I've seen that tries to measure things quantitatively comes to the opposite conclusion. The gullible are already getting snake-oil in the form of herbal remedies and homeopathy.
- klenwell 14y ago
  The point here is that this drug hasn't been tested for its safety, much less its efficacy. It is still at an early testing stage. The researchers seem to have a reasonable theory for why they believe it will be effective. But molecular biology is complicated and the risk for harmful effects in humans is not trivial. Ben Goldacre's book Bad Pharma details the serious personal and social costs that come with poor drug trials. Everyone urging the abandonment of caution here seems to assume this new drug already works or, at the very least, the effects of its usage could not be worse than the grim prognosis patients already confront. But that's what proper trials are meant to establish. Snake oil can come in pill form, too. And even with the current precautions, we've ended up with a number of ineffective, expensive, and sometimes deadly drugs on the market.
- crusso 14y ago
  I'd go further in saying that the gullible are going online where they learn of really shady solutions. From there, they go underground or to other countries to get snake-oil of a particularly strong reptilian flavor. As with the drug war, we drive people into being basically criminals when they're in reality suffering from a medical condition. So rather than being allowed to experiment with extremely desperate volunteers who could likely one day provide some real EUREKA therapies, we send those folks to the dark side where they're much more likely to spend a great deal of money and be taken advantage of. That's a huge practical loss, but an even greater ethical loss. At its very core, we are throwing away people's right to choose what to do with their own bodies. Being okay with that ethical tragedy is like being okay with rape or torture for some poorly proven "greater good".
- Kudzu_Bob 14y ago
fghh45sdfhr3 14y ago
The problem is that lay people have essentially no ability to distinguish between potential 'last shots'. And exemptions will invite snake-oil salesmen. So because some people will be duped, let's doom everyone to death.
wamatt 14y ago
>"lay people have essentially no ability to distinguish between potential 'last shots'" I'm sure you mean well, but this type of thinking really bothers me. For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as lay people. However the central issue is a medical doctor is not even qualified enough to choose, due to malpractice liability. On top of that even a specialist can find difficulty prescribing experimental treatment lawfully, unless it's part of an FDA trial. This is in addition to the incentives drug companies push. [1] I speak from first hand experience dealing with Psoriatic Arthritis and establishment CYA (cover your ass) thinking. After spending $1000+ per month on Anti-TNF blockers [2], I'm doing just fine on lifestyle changes and have seen no disease progression after 3 years of being off meds. I wouldn't bother mentioning it if it weren't for the thousands of credible patient stories that point to fixing what we eat as a means to being healthy. Yet the paradigm for the last 30 years is one of treatment, not prevention. Guess which makes more money for Pfizer, GSK etc? Hint: it's not vaccines (prevention). Chronic treatment (autoimmune, psych drugs, cvd etc) are dominating the top 10 sales charts. [3] I would feel incredibly angry and upset if myself or someone close to me, were in a position to try an experimental cancer treatment, but were unable to, because of regulatory snakes and ladders. I'm not saying the FDA is useless or provides no public benefit, but I would question the wisdom behind entrusting authority of one's life, to a single decision making body. [1] http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-pharmaceutical-companies-raise-issues-of-conflicts.html?_r=0 http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-... [2] http://en.wikipedia.org/wiki/Etanercept http://en.wikipedia.org/wiki/Etanercept [3] http://en.wikipedia.org/wiki/List_of_largest_selling_pharmaceutical_products http://en.wikipedia.org/wiki/List_of_largest_selling_pharmac...
- droopyEyelids 14y ago
  >For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as "lay people". The fact that you think critical reasoning can help discriminate between a quack and someone selling real medicine indicates you don't have the ability to make that distinction. The truth is, no one does. It takes a process with many checks, and even then snake oil makes it through. Hell, the same people who make real medicine can have a lapse of judgment and make phony medicine. No one could tell, even their peers, without verifying the experiments performed. It's not a far-fetched scenario. Prominent researchers fall from grace several times a year. Multinational drug companies sell medicines that perform worse than placebos.

by roc 14y ago

wwwtyro 14y ago

They aren't without their downsides, but they remain better than the alternative on balance. That's not a credible claim. Tell that to either of the two people that left those comments. Sure, there's risks inherent with experimental drugs, but these people are dying or losing loved ones. They don't give a damn, and none of us has any right to stop them from taking those risks with their own persons. Their bodies are their own, they are not yours. And frankly, the snake-oil salesman claim strikes me as little more than FUD. People can get recommendations from multiple MDs before making up their minds.

rubyrescue 14y ago
The history of snake-oil salesmen is well documented. http://www.authentichistory.com/1898-1913/2-progressivism/8-quackery/ http://www.authentichistory.com/1898-1913/2-progressivism/8-...
- wwwtyro 14y ago
  I'm not denying their existence.
- maxharris 14y ago
  Why is it OK to lump honest physicians, researchers and patients in with snake oil salesmen and their victims? Why is it morally acceptable to have laws intended to help the people that don't care to tell the difference? Those laws come at the expense of those who do care, who take the trouble to figure things out. Why shouldn't we live in a free society where the best within us can make a difference, and take humanity forward?
  - Retric 14y ago
    Why is it OK to lump honest physicians, researchers and patients in with snake oil salesmen and their victims? The best snake oil salesmen believe in their products. There are already exceptions for allowing people to take highly experimental procedures when there likely to die without them. However, there are plenty of cases where highly trained well meaning doctors caused massive suffering without benefit to their direct patents. As a recent example of fringe medicine, a few athletes have injected themselves with stem cells. Not to mention the modern version of doping which often involves substances that are known to be harmful or medicine has little idea what the long term effects are.
    - maxharris 14y ago
      So we should treat every physician, researcher and patient as guilty, incorrect or foolish until proven innocent, correct or wise? However, there are plenty of cases where highly trained well meaning doctors caused massive suffering without benefit to their direct patents. No one is omniscient. The ideal in medicine can't be something impossible (i.e., medicine that cures all ills and everyone, and never has any risks or side effects). No one knows how to do that (now and for the foreseeable future), and we shouldn't deny people the best chance they have at life to chase an impossibility.
      - Retric 14y ago
        So we should treat ... researcher... as guilty, incorrect or foolish until proven innocent, correct or wise? Yes, that's the point of peer review.
        maxharris 14y ago
        Peer review is just another thing that helps individuals decide scientific matters for themselves. The implicit idea behind peer review can be summed up like this: "This is what I think about this work. (I have credentials X, Y, and Z, and I've published this stuff you many have heard of.) What I have to say is just another thing for you to consider. Take it or leave it."
noonespecial 14y ago
For what its worth, I agree with you, but the other side is not so unreasonable as it seems. The risk is not to the dying. The risk is that selection bias (of the miracle survivors) might cause an ineffectual drug to creep down the chain of "desperateness" (from the truly desperate to the less so) until it possibly occludes treatments that do work.

Symmetry 14y ago

Yet somehow countries that regulate drugs merely by safety tend to produce better health outcomes than countries that regulate for safety and efficacy like the US FDA does. You're just asserting that the upsides outweigh the downsides, but every study I've seen that tries to measure things quantitatively comes to the opposite conclusion. The gullible are already getting snake-oil in the form of herbal remedies and homeopathy.

klenwell 14y ago
The point here is that this drug hasn't been tested for its safety, much less its efficacy. It is still at an early testing stage. The researchers seem to have a reasonable theory for why they believe it will be effective. But molecular biology is complicated and the risk for harmful effects in humans is not trivial. Ben Goldacre's book Bad Pharma details the serious personal and social costs that come with poor drug trials. Everyone urging the abandonment of caution here seems to assume this new drug already works or, at the very least, the effects of its usage could not be worse than the grim prognosis patients already confront. But that's what proper trials are meant to establish. Snake oil can come in pill form, too. And even with the current precautions, we've ended up with a number of ineffective, expensive, and sometimes deadly drugs on the market.
crusso 14y ago
I'd go further in saying that the gullible are going online where they learn of really shady solutions. From there, they go underground or to other countries to get snake-oil of a particularly strong reptilian flavor. As with the drug war, we drive people into being basically criminals when they're in reality suffering from a medical condition. So rather than being allowed to experiment with extremely desperate volunteers who could likely one day provide some real EUREKA therapies, we send those folks to the dark side where they're much more likely to spend a great deal of money and be taken advantage of. That's a huge practical loss, but an even greater ethical loss. At its very core, we are throwing away people's right to choose what to do with their own bodies. Being okay with that ethical tragedy is like being okay with rape or torture for some poorly proven "greater good".
Kudzu_Bob 14y ago

fghh45sdfhr3 14y ago

The problem is that lay people have essentially no ability to distinguish between potential 'last shots'. And exemptions will invite snake-oil salesmen. So because some people will be duped, let's doom everyone to death.

wamatt 14y ago

>"lay people have essentially no ability to distinguish between potential 'last shots'" I'm sure you mean well, but this type of thinking really bothers me. For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as lay people. However the central issue is a medical doctor is not even qualified enough to choose, due to malpractice liability. On top of that even a specialist can find difficulty prescribing experimental treatment lawfully, unless it's part of an FDA trial. This is in addition to the incentives drug companies push. [1] I speak from first hand experience dealing with Psoriatic Arthritis and establishment CYA (cover your ass) thinking. After spending $1000+ per month on Anti-TNF blockers [2], I'm doing just fine on lifestyle changes and have seen no disease progression after 3 years of being off meds. I wouldn't bother mentioning it if it weren't for the thousands of credible patient stories that point to fixing what we eat as a means to being healthy. Yet the paradigm for the last 30 years is one of treatment, not prevention. Guess which makes more money for Pfizer, GSK etc? Hint: it's not vaccines (prevention). Chronic treatment (autoimmune, psych drugs, cvd etc) are dominating the top 10 sales charts. [3] I would feel incredibly angry and upset if myself or someone close to me, were in a position to try an experimental cancer treatment, but were unable to, because of regulatory snakes and ladders. I'm not saying the FDA is useless or provides no public benefit, but I would question the wisdom behind entrusting authority of one's life, to a single decision making body. [1] http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-pharmaceutical-companies-raise-issues-of-conflicts.html?_r=0 http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-... [2] http://en.wikipedia.org/wiki/Etanercept http://en.wikipedia.org/wiki/Etanercept [3] http://en.wikipedia.org/wiki/List_of_largest_selling_pharmaceutical_products http://en.wikipedia.org/wiki/List_of_largest_selling_pharmac...

droopyEyelids 14y ago
>For example, many of us here on HN, possess the critical reasoning skills to determine snake oil from a credible research lab. Given that there are almost no practicing oncologists present, we'd all likely qualify as "lay people". The fact that you think critical reasoning can help discriminate between a quack and someone selling real medicine indicates you don't have the ability to make that distinction. The truth is, no one does. It takes a process with many checks, and even then snake oil makes it through. Hell, the same people who make real medicine can have a lapse of judgment and make phony medicine. No one could tell, even their peers, without verifying the experiments performed. It's not a far-fetched scenario. Prominent researchers fall from grace several times a year. Multinational drug companies sell medicines that perform worse than placebos.