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It's fun to heap criticism on China's research. There's too many fraudulent results, as a culture they don't value out of the box thinking, ect. That kind of th

It's fun to heap criticism on China's research. There's too many fraudulent results, as a culture they don't value out of the box thinking, ect. That kind of thinking hurts us, not China. But as a researcher in the US working with data collected from Human samples, I will attest that the bottleneck to progress are the regulations. What we don't want are regulations that make it impossible to get the research started. What we want are regulations that ensure that new drugs and treatments sold on the markert actually work. This is exactly the opposite of the situation in the US today.

amelius 9y ago
Can you give some examples of regulations that are counter-productive, where their suspension presents no ethical challenge?
- rconti 9y ago
  If even one person could die, there's ALWAYS an ethical challenge. Unfortunately, we disregard the ethical challenge in not trying.
- JamesBarney 9y ago
  The trick is in "no ethical challenge". Why should the answer to the number of years or lives we sacrifice to cure Alzheimer's be 0?
- frozenport 9y ago
  The article gives a good one. The patients in the article are going to die in months, why not try something?
- jostmey 9y ago
  Took ~2 years to get approval to be able to seek patient permission to have their discarded tissue sequenced. Now that we are forming questions with the results, I hope it won't take another 2 years to get approval to run new tests :-/ In, retrospect is it even worth it?
- ramblenode 9y ago
  The FDA and USDA come to mind as institutions with a lot of questionable health policies. "To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often enhances safety and effectiveness, but requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped, even saved, are not. In addition, because FDA approval is mandatory, industry and medicine must heed FDA standards regardless of their relevance, efficiency, and appropriateness. Not all testing is equally beneficial. The FDA apparatus mandates testing that, in some cases, is not useful or not appropriately designed. The case against the FDA is not that premarket testing is unnecessary but that the costs and benefits of premarket testing would be better evaluated and the trade-offs better navigated in a voluntary, competitive system of drug development. Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label drug uses in the United States with the on-label market. In the final section, before turning to reform options, we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits." http://www.fdareview.org/05_harm.php http://www.fdareview.org/05_harm.php This may not be the most neutral source, but it at least raises some interesting points.
  - jadedhacker 9y ago
    This is not a specific criticism of a regulation that would meet the standard of removing regulations that would not produce harmful effects, it is a blanket criticism that dismisses the reason why the regulations exist at all. Yes, moving more quickly would save more lives... but at what expense? That expense would be more human lives diminished by medical experimentation. Perhaps those patients would accept that cost if there were a possibility of life saving drugs being more rapidly discovered. In that case, we have to ask, what is the likely actual result of revoking regulations? Most of those regulations are written in blood. This broad critique that doesn't specifically analyze a particular regulation is dangerous, because it neglects the role of the profit motive. Profit motive results in the externalization of costs to acquire more money. In general this results in snake oil, addictive medicines, wars, and ruined bodies. It also results in processes being cost optimized, though often the costs are simply externalized by the corporation, cheating, rather than making real progress. I strongly suspect that taking the leash off the corporate drug makers and researchers will result in an increase in human misery, rather than a reduction. A non-profit with secure (i.e. public) funding might be more well equipped to use their good sense in the absence of some regulations. I'll grant there may be some unproductive regulations, but the argument must be specific and evidence based rather than a generic broadside at all of them.
- jimrandomh 9y ago
  http://slatestarcodex.com/2017/08/29/my-irb-nightmare/ http://slatestarcodex.com/2017/08/29/my-irb-nightmare/
  - jostmey 9y ago
    +1
Sangermaine 9y ago
>It's fun to heap criticism on China's research. There's too many fraudulent results, as a culture they don't value out of the box thinking, ect. That kind of thinking hurts us, not China. You'll have to explain how being critical of fraudulent results "hurts us, not China", unless you're implying the criticism isn't valid, but from what I've read it's a very real concern in research coming from China.
- lopmotr 9y ago
  I'd say the same way any criticism hurts the party believing it, not the one it's directed at. It increases your confidence in yourself without any corresponding increase in you real performance. In this case, public perception of superiority might lead to the US keeping its drug trials slow and expensive, reducing the amount of medical technology invented there compared to China.
  - Sangermaine 9y ago
    >I'd say the same way any criticism hurts the party believing it, not the one it's directed at. That doesn't make any sense. If the criticism is accurate, then it hurts the criticized party because it's true, whether or not they accept the criticism. > It increases your confidence in yourself without any corresponding increase in you real performance You don't need to increase your performance if the other side is lying about how well it's doing and you know it. Your confidence in yourself is well-founded in this situation. >In this case, public perception of superiority might lead to the US keeping its drug trials slow and expensive, reducing the amount of medical technology invented there compared to China. If China is actually producing a significant amount of fraudulent research, then their development will be hindered by their own fraud, which is the point. If their technological development is premised on fraudulent research, it won't advance. You seem to think this is just a matter of opinion that can be freely ignored. You seem to have a completely backwards understanding of the concept of criticism.
    - lopmotr 9y ago
      It's true whether or not anybody says it. If nobody criticized China, all those problem would still be there. Except people in the US wouldn't be so confident of their superiority. I think that would get them worried into action, like they got worried into the space race by Sputnik as the article mentioned. It is a matter of opinion - public opinion - which is what ultimately drives how the FDA works. If the US public is clamoring for them to get their ass into gear, eventually they will.

amelius 9y ago

Can you give some examples of regulations that are counter-productive, where their suspension presents no ethical challenge?

rconti 9y ago
If even one person could die, there's ALWAYS an ethical challenge. Unfortunately, we disregard the ethical challenge in not trying.
JamesBarney 9y ago
The trick is in "no ethical challenge". Why should the answer to the number of years or lives we sacrifice to cure Alzheimer's be 0?
frozenport 9y ago
The article gives a good one. The patients in the article are going to die in months, why not try something?
jostmey 9y ago
Took ~2 years to get approval to be able to seek patient permission to have their discarded tissue sequenced. Now that we are forming questions with the results, I hope it won't take another 2 years to get approval to run new tests :-/ In, retrospect is it even worth it?
ramblenode 9y ago
The FDA and USDA come to mind as institutions with a lot of questionable health policies. "To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often enhances safety and effectiveness, but requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped, even saved, are not. In addition, because FDA approval is mandatory, industry and medicine must heed FDA standards regardless of their relevance, efficiency, and appropriateness. Not all testing is equally beneficial. The FDA apparatus mandates testing that, in some cases, is not useful or not appropriately designed. The case against the FDA is not that premarket testing is unnecessary but that the costs and benefits of premarket testing would be better evaluated and the trade-offs better navigated in a voluntary, competitive system of drug development. Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label drug uses in the United States with the on-label market. In the final section, before turning to reform options, we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits." http://www.fdareview.org/05_harm.php http://www.fdareview.org/05_harm.php This may not be the most neutral source, but it at least raises some interesting points.
- jadedhacker 9y ago
  This is not a specific criticism of a regulation that would meet the standard of removing regulations that would not produce harmful effects, it is a blanket criticism that dismisses the reason why the regulations exist at all. Yes, moving more quickly would save more lives... but at what expense? That expense would be more human lives diminished by medical experimentation. Perhaps those patients would accept that cost if there were a possibility of life saving drugs being more rapidly discovered. In that case, we have to ask, what is the likely actual result of revoking regulations? Most of those regulations are written in blood. This broad critique that doesn't specifically analyze a particular regulation is dangerous, because it neglects the role of the profit motive. Profit motive results in the externalization of costs to acquire more money. In general this results in snake oil, addictive medicines, wars, and ruined bodies. It also results in processes being cost optimized, though often the costs are simply externalized by the corporation, cheating, rather than making real progress. I strongly suspect that taking the leash off the corporate drug makers and researchers will result in an increase in human misery, rather than a reduction. A non-profit with secure (i.e. public) funding might be more well equipped to use their good sense in the absence of some regulations. I'll grant there may be some unproductive regulations, but the argument must be specific and evidence based rather than a generic broadside at all of them.
jimrandomh 9y ago
http://slatestarcodex.com/2017/08/29/my-irb-nightmare/ http://slatestarcodex.com/2017/08/29/my-irb-nightmare/
- jostmey 9y ago
  +1

Sangermaine 9y ago

>It's fun to heap criticism on China's research. There's too many fraudulent results, as a culture they don't value out of the box thinking, ect. That kind of thinking hurts us, not China. You'll have to explain how being critical of fraudulent results "hurts us, not China", unless you're implying the criticism isn't valid, but from what I've read it's a very real concern in research coming from China.

lopmotr 9y ago
I'd say the same way any criticism hurts the party believing it, not the one it's directed at. It increases your confidence in yourself without any corresponding increase in you real performance. In this case, public perception of superiority might lead to the US keeping its drug trials slow and expensive, reducing the amount of medical technology invented there compared to China.
- Sangermaine 9y ago
  >I'd say the same way any criticism hurts the party believing it, not the one it's directed at. That doesn't make any sense. If the criticism is accurate, then it hurts the criticized party because it's true, whether or not they accept the criticism. > It increases your confidence in yourself without any corresponding increase in you real performance You don't need to increase your performance if the other side is lying about how well it's doing and you know it. Your confidence in yourself is well-founded in this situation. >In this case, public perception of superiority might lead to the US keeping its drug trials slow and expensive, reducing the amount of medical technology invented there compared to China. If China is actually producing a significant amount of fraudulent research, then their development will be hindered by their own fraud, which is the point. If their technological development is premised on fraudulent research, it won't advance. You seem to think this is just a matter of opinion that can be freely ignored. You seem to have a completely backwards understanding of the concept of criticism.
  - lopmotr 9y ago
    It's true whether or not anybody says it. If nobody criticized China, all those problem would still be there. Except people in the US wouldn't be so confident of their superiority. I think that would get them worried into action, like they got worried into the space race by Sputnik as the article mentioned. It is a matter of opinion - public opinion - which is what ultimately drives how the FDA works. If the US public is clamoring for them to get their ass into gear, eventually they will.