5 ms·

I think it's bad policy for the FDA to screen medicines not just for safety but also efficacy. From this study it appears to be frequently unjustified but it gi

I think it's bad policy for the FDA to screen medicines not just for safety but also efficacy. From this study it appears to be frequently unjustified but it gives the drug a seal of approval that has a tendency to replace the judgement of doctors and patients. It's not that the FDA decision makers are corrupt or incompetent. These are wildly complex issues that nobody can get right consistently. Better not to conceal that with centralized decision making. Modern medicine can't even agree in broad strokes on the proper ratio of macronutrients for humans. We give them too much power when we uncritically accept their judgement on any given treatment. For me, prayer would have no effect. For others it could be a life saving intervention. The efficacy of a particular molecule for a particular patient isn't much easier than that to determine. Therefore decision making should be as decentral and computationally parallel as we can make it.

rileymat2 7y ago
It seems wrong to judge based on the number of false positives without weighing agianst all the snake oil they keep out.
avar 7y ago
Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.
- kanzure 7y ago
  > Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug. Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy. https://www.technologyreview.com/s/603530/a-biohackers-plan-to-upgrade-dalmatians-ends-up-in-the-doghouse/ https://www.technologyreview.com/s/603530/a-biohackers-plan-... On another note, see the sensor pads story here: http://www.fdareview.org/devices.shtml http://www.fdareview.org/devices.shtml "We rarely get to try products that the FDA fails to approve, and we never get to try products that are never brought into existence because FDA rules and regulations have made research and development uneconomic. As a result, the public remains ignorant of the true costs of FDA power."
  - opencl 7y ago
    What kind of bizarre definition of the term "medical procedure" would exclude using CRISPR gene editing to get rid of an inherited disease?
    - kanzure 7y ago
      Well, the one that says medical procedures are only practiced on people.... and that embryo editing is not editing a person. But anyway, we really do need a way for people to let themselves opt out of the FDA's regulatory regime for all sorts of reasons- chronic pain, euthanasia, pick your poison there's thousands.
  - avar 7y ago
    The story you've linked to is where the FDA shut down some private individual selling genetically modified dogs to the public. But yes, the FDA aren't complete morons. If you're selling genetically modified dogs you're obviously selling the results of an unapproved medical procedure to the public, even if all you say about it is that you're selling fluffy friends to the public. The second story you've linked to is one where someone was clearly trying to sell a replacement for breast examinations to the public. I've never heard about the "sensor pad" before, and there's probably a good case to me made for such a device being more beneficial than not, and that the FDA made a mistake etc. But I think their process is more sound than not in demanding clinical trials of these sorts of products. This is because in practice people will use them as a replacement for going to their physician, so having some DYI breast cancer scanning kit doesn't just need to be harmless in isolation. You also need to consider the increased death rate from people not going to their doctor for an examination as a result.
  - magduf 7y ago
    >Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy. This is completely false. Proof: homeopathy and chiropractic are very popular and still on the market.
SolaceQuantum 7y ago
Even computationally parallel algorithms hopefully have a centralization point where the compulation completes. What's the equivalent for whether or not a drug is more effective than a sugar pill, given countless edge cases? I could imagine a case where a drug that was never effective is widely distributed before being calculated to be no more effective than placebo. In the meantime, such a widely distributed drug could cause significant harm as it is selected over medication with actual efficiacy or effective drugs avoided due to the side effects of the ineffective one.
michaelbuckbee 7y ago
Efficacy is important as many drugs have significant side effects. If a drug is not going to actually reduce your chance of heart attack or help treat aggressive cancer it's likely not worth the trade-off with side effects.
- homonculus1 7y ago
  Not to mention cost, and the opportunity costs that emerge from it.
  - PakG1 7y ago
    Part of the opportunity cost being that you could have chosen a more effective treatment if the bar had been set higher. Difficult for patients to be able to correctly determine whether a treatment would actually be good for them. They're not in a good place to decide, for the same reason why lawyers should never represent themselves if possible.
Scoundreller 7y ago
> The efficacy of a particular molecule for a particular patient isn't much easier than that to determine. How do you handle situations where the provider doesn’t know/care which is best either and just chooses the intervention that was the most heavily marketed to them? Why do we see new patent drugs replace the “old and boring” generics without any proven efficacy benefit?
- sametmax 7y ago
  You make public health care with fixed prices to contain the capitalism incentive. Worked for us in france: hospitals get pressure from the state and must justify their refundable expenses. It's not perfect, there are still abuses, but it's nowhere the circus we see in the US.
  - Scoundreller 7y ago
    How about outpatient prescriptions? Does a GP (or group thereof) get a budget of expenditures on prescriptions that they have to stay within?
    - sametmax 7y ago
      I never heard about it.
teh_infallible 7y ago
You lost me when you made the assertion that the FDA isn’t corrupt.
- la_barba 7y ago
  Is this a general assertion that "government" is corrupt, or do you have any specific assertions? Can you describe how you think drugs are approved and at what stage the "corrupt" FDA manifests itself?
komali2 7y ago
Typically the efficacy stamp does come with whatever caveats came up during FDA approval - for example, my SSRIs came with two sheets of double sided paper listing in excruciating detail the potential side effects, and reminding me on every page that the pills may just make me want to kill myself so watch out for that. SSRIs being top of the list of drugs that "sometimes work sometimes don't" I think are a good example of why the FDA rubber stamping efficacy are still good. I'm not convinced I'd had those sheets of paper if drug makers had the run of the market. I've never actually seen evidence that a "free market" (i.e. drug market with no FDA) results in a better world for consumers, unilaterally.
sysbin 7y ago
Please, let's not kid ourselves about what actually is life saving intervention for a person. It downplays the need for funding and we're already dealing with a lot of suicides per day.
maxxxxx 7y ago
“Therefore decision making should be as decentral and computationally parallel as we can make ” This may work if the decentralized decisions were made based on results. But they are often made based on profits and there is a lot of money to be made in doing useless therapies.
richardthered 7y ago
Without some kind of efficacy standard, you could sell water as a cancer cure. That would be very bad for health outcomes. However, I do agree that it's a difficult topic, in general. Off-label drug uses is one example.
- nybble41 7y ago
  That would be plain false advertising. The FDA doesn't need to get involved in such trivia. I have no problem with the FDA as a certification agency, whether they're certifying safety or efficacy or both. I do have a problem with their approval being mandatory in order for the product to be sold. If their stamp of approval means anything—if lack of FDA approval implies that a product is unsafe and/or ineffective—then doctors, insurers, and patients will all look for that approval and avoid products without it. The problem is that "safe and effective" is neither necessary nor sufficient to obtain FDA approval.
  - pas 7y ago
    The lack of safety would affect those who can't afford the "approved" options. :/
    - nybble41 7y ago
      Which is more likely to cause an issue, a treatment with no FDA safety approval (but also no history of problems, and possibly safety approval from some other trusted organization) or going without treatment altogether because you can't afford the one with FDA approval and everything else is prohibited? The existence of uncertified, or just differently certified, options should also put some downward pressure on the prices of the certified options compared to the current monopoly environment. When everyone has to obtain FDA approval there is no incentive to minimize the cost and plenty of reason for established incumbents to make approval as expensive as possible to lock out any potential competition. You can always push for "more safety" above and beyond the level of risk reasonable people would be willing to accept.
      - 7y ago
happy-go-lucky 7y ago
> For me, prayer would have no effect. For others it could be a life saving intervention. In the same vein, I often get to read about an emerging approach called precision medicine. Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology or prognosis of those diseases they may develop, or in their response to a specific treatment [1] [1] https://en.wikipedia.org/wiki/Precision_medicine https://en.wikipedia.org/wiki/Precision_medicine
Symmetry 7y ago
Also sometimes a medicine's most important uses end up being off-label anyways. E.g. http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html

rileymat2 7y ago

It seems wrong to judge based on the number of false positives without weighing agianst all the snake oil they keep out.

avar 7y ago

Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.

kanzure 7y ago
> Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug. Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy. https://www.technologyreview.com/s/603530/a-biohackers-plan-to-upgrade-dalmatians-ends-up-in-the-doghouse/ https://www.technologyreview.com/s/603530/a-biohackers-plan-... On another note, see the sensor pads story here: http://www.fdareview.org/devices.shtml http://www.fdareview.org/devices.shtml "We rarely get to try products that the FDA fails to approve, and we never get to try products that are never brought into existence because FDA rules and regulations have made research and development uneconomic. As a result, the public remains ignorant of the true costs of FDA power."
- opencl 7y ago
  What kind of bizarre definition of the term "medical procedure" would exclude using CRISPR gene editing to get rid of an inherited disease?
  - kanzure 7y ago
    Well, the one that says medical procedures are only practiced on people.... and that embryo editing is not editing a person. But anyway, we really do need a way for people to let themselves opt out of the FDA's regulatory regime for all sorts of reasons- chronic pain, euthanasia, pick your poison there's thousands.
- avar 7y ago
  The story you've linked to is where the FDA shut down some private individual selling genetically modified dogs to the public. But yes, the FDA aren't complete morons. If you're selling genetically modified dogs you're obviously selling the results of an unapproved medical procedure to the public, even if all you say about it is that you're selling fluffy friends to the public. The second story you've linked to is one where someone was clearly trying to sell a replacement for breast examinations to the public. I've never heard about the "sensor pad" before, and there's probably a good case to me made for such a device being more beneficial than not, and that the FDA made a mistake etc. But I think their process is more sound than not in demanding clinical trials of these sorts of products. This is because in practice people will use them as a replacement for going to their physician, so having some DYI breast cancer scanning kit doesn't just need to be harmless in isolation. You also need to consider the increased death rate from people not going to their doctor for an examination as a result.
- magduf 7y ago
  >Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy. This is completely false. Proof: homeopathy and chiropractic are very popular and still on the market.

SolaceQuantum 7y ago

Even computationally parallel algorithms hopefully have a centralization point where the compulation completes. What's the equivalent for whether or not a drug is more effective than a sugar pill, given countless edge cases? I could imagine a case where a drug that was never effective is widely distributed before being calculated to be no more effective than placebo. In the meantime, such a widely distributed drug could cause significant harm as it is selected over medication with actual efficiacy or effective drugs avoided due to the side effects of the ineffective one.

michaelbuckbee 7y ago

Efficacy is important as many drugs have significant side effects. If a drug is not going to actually reduce your chance of heart attack or help treat aggressive cancer it's likely not worth the trade-off with side effects.

homonculus1 7y ago
Not to mention cost, and the opportunity costs that emerge from it.
- PakG1 7y ago
  Part of the opportunity cost being that you could have chosen a more effective treatment if the bar had been set higher. Difficult for patients to be able to correctly determine whether a treatment would actually be good for them. They're not in a good place to decide, for the same reason why lawyers should never represent themselves if possible.

Scoundreller 7y ago

> The efficacy of a particular molecule for a particular patient isn't much easier than that to determine. How do you handle situations where the provider doesn’t know/care which is best either and just chooses the intervention that was the most heavily marketed to them? Why do we see new patent drugs replace the “old and boring” generics without any proven efficacy benefit?

sametmax 7y ago
You make public health care with fixed prices to contain the capitalism incentive. Worked for us in france: hospitals get pressure from the state and must justify their refundable expenses. It's not perfect, there are still abuses, but it's nowhere the circus we see in the US.
- Scoundreller 7y ago
  How about outpatient prescriptions? Does a GP (or group thereof) get a budget of expenditures on prescriptions that they have to stay within?
  - sametmax 7y ago
    I never heard about it.

teh_infallible 7y ago

You lost me when you made the assertion that the FDA isn’t corrupt.

la_barba 7y ago
Is this a general assertion that "government" is corrupt, or do you have any specific assertions? Can you describe how you think drugs are approved and at what stage the "corrupt" FDA manifests itself?

komali2 7y ago

Typically the efficacy stamp does come with whatever caveats came up during FDA approval - for example, my SSRIs came with two sheets of double sided paper listing in excruciating detail the potential side effects, and reminding me on every page that the pills may just make me want to kill myself so watch out for that. SSRIs being top of the list of drugs that "sometimes work sometimes don't" I think are a good example of why the FDA rubber stamping efficacy are still good. I'm not convinced I'd had those sheets of paper if drug makers had the run of the market. I've never actually seen evidence that a "free market" (i.e. drug market with no FDA) results in a better world for consumers, unilaterally.

sysbin 7y ago

Please, let's not kid ourselves about what actually is life saving intervention for a person. It downplays the need for funding and we're already dealing with a lot of suicides per day.

maxxxxx 7y ago

“Therefore decision making should be as decentral and computationally parallel as we can make ” This may work if the decentralized decisions were made based on results. But they are often made based on profits and there is a lot of money to be made in doing useless therapies.

richardthered 7y ago

Without some kind of efficacy standard, you could sell water as a cancer cure. That would be very bad for health outcomes. However, I do agree that it's a difficult topic, in general. Off-label drug uses is one example.

nybble41 7y ago
That would be plain false advertising. The FDA doesn't need to get involved in such trivia. I have no problem with the FDA as a certification agency, whether they're certifying safety or efficacy or both. I do have a problem with their approval being mandatory in order for the product to be sold. If their stamp of approval means anything—if lack of FDA approval implies that a product is unsafe and/or ineffective—then doctors, insurers, and patients will all look for that approval and avoid products without it. The problem is that "safe and effective" is neither necessary nor sufficient to obtain FDA approval.
- pas 7y ago
  The lack of safety would affect those who can't afford the "approved" options. :/
  - nybble41 7y ago
    Which is more likely to cause an issue, a treatment with no FDA safety approval (but also no history of problems, and possibly safety approval from some other trusted organization) or going without treatment altogether because you can't afford the one with FDA approval and everything else is prohibited? The existence of uncertified, or just differently certified, options should also put some downward pressure on the prices of the certified options compared to the current monopoly environment. When everyone has to obtain FDA approval there is no incentive to minimize the cost and plenty of reason for established incumbents to make approval as expensive as possible to lock out any potential competition. You can always push for "more safety" above and beyond the level of risk reasonable people would be willing to accept.
    - 7y ago

happy-go-lucky 7y ago

> For me, prayer would have no effect. For others it could be a life saving intervention. In the same vein, I often get to read about an emerging approach called precision medicine. Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology or prognosis of those diseases they may develop, or in their response to a specific treatment [1] [1] https://en.wikipedia.org/wiki/Precision_medicine https://en.wikipedia.org/wiki/Precision_medicine

Symmetry 7y ago

Also sometimes a medicine's most important uses end up being off-label anyways. E.g. http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html