4 ms·

I think we need like three or four different certifications escalating in terms of difficulty to get: 0) generally recognized as safe and free of containments

I think we need like three or four different certifications escalating in terms of difficulty to get: 0) generally recognized as safe and free of containments - it won't kill you and you get what is on the label. This should be applied and enforced through some kind of mandatory batch testing. Supplements desperately need this because you really have no idea about what you're getting. 1) Plausible Efficacy - this is 0 plus a plausible efficacy for the marketing claim. I.e there is some mechanism of action or reasonable amount of evidence this could work. Marketing would have to make this clear. Most OTC medications should be under this standard. 2) FDA proven efficacy - this is the highest standard of proof, basically the current standard. Prescription medications should be held to this standard. maybe 3) YOLO/Emergency/Terminal illness authorization - can't be marketed, only listed in a government index and you need a DR co-sign and acknowledge that it may kill you, is unproven and the outcome is recorded for the purposes of later study.

junofan 3y ago
The FDA doesn’t prove anything. They evaluate claims.
- B1FF_PSUVM 3y ago
  I'd take "FDA proven" to be shorthand for "proven to FDA's satisfaction".
jalapenos 3y ago
Or we could just dissolve it and go back to being responsible for our own outcomes.
- p1mrx 3y ago
  How can an individual without a laboratory be responsible for the contents of a pill they purchased?
  - JoshTriplett 3y ago
    Read a detailed review from a well-regarded neutral party with a laboratory.
    - hwillis 3y ago
      If there were any market incentive whatsoever for that, it would already exist. The FDA does not have magical anticompetitive powers that make people care less. We have private and public postal services and railroads operating alongside each other. The best case scenario is that there is enough market will to allow a lab to monopolize the market, leaving you with the same problems as today but with even less standing in the way of fraud, like companies just paying for good reviews. The realistic case is that no such testing would happen, just like it was before the FDA.
      - JoshTriplett 3y ago
        > If there were any market incentive whatsoever for that, it would already exist. Consumer Reports already exists. https://www.consumerlab.com/ https://www.consumerlab.com/ exists. And the FDA is part of why there is no market for it. Note, for instance, tat the above-mentioned site reviews supplements, which don't have as many restrictions (and which do very much need these kinds of reviews). > like companies just paying for good reviews That would conflict with "respected review company", and leave an opportunity for a company that doesn't accept any kind of payment.
        jrajav 3y ago
        What kind of precedent is there for this pattern working successfully, long term, in any industry? 'Review companies' get sabotaged all the time if they were ever reliable at all. I sure wouldn't want to rely on one for medicine I give to my family if it was anything like relying on Yelp for a decent restaurant. I'm not at all convinced that the open market is a valid locale for these incentives - it seems to come with inherent conflict of interest. Maybe it's reasonable for us to agree that some kinds of oversight are worth funding as a society without waiting for incentives to sprout up out of the ground.
soared 3y ago
#3 exists - drug trials occur in hospitals (research hospitals?). My only knowledge is late stage cancer where death is all but a certainty, so they can test new cancer drugs with doctor/patient/etc/drug company consent and oversight. Your ability to enter a trial is largely out of your hands though - if your case fits the conditions for a test you can ask around or your doctor may offer, but plenty of factors can rule you out.
- bruce511 3y ago
  Taking "no hope" patients into a clinical trial is something of a bad-science dillema. On one hand you have patients either a certain death diagnosis. They'll take anything, they have nothing to lose. From the drug trial point of view its more complex. Your death and side-effects are recorded. It's not great if half the people in a study die. What if 90% die? Adding lots of one type of patient yo one side of a study, without adding similar to the control group, invalidates the whole study. And people who are already "hopeless" may end up masking the good outcomes for people earlier in treatment. Currently there's no mechanism for random unproven drugs to be disseminated outside of a study, but equally its a rare study that wants to add "certain death" candidates to the roster. If we want "hail mary" options in drug administration then we need that to exist outside of nedical studies. And formalising this would be difficult because one senses that moves in this direction would open the door to massive exploitation and profiteering by both snake-oil salesmen and big pharma.

junofan 3y ago

The FDA doesn’t prove anything. They evaluate claims.

B1FF_PSUVM 3y ago
I'd take "FDA proven" to be shorthand for "proven to FDA's satisfaction".

jalapenos 3y ago

Or we could just dissolve it and go back to being responsible for our own outcomes.

p1mrx 3y ago
How can an individual without a laboratory be responsible for the contents of a pill they purchased?
- JoshTriplett 3y ago
  Read a detailed review from a well-regarded neutral party with a laboratory.
  - hwillis 3y ago
    If there were any market incentive whatsoever for that, it would already exist. The FDA does not have magical anticompetitive powers that make people care less. We have private and public postal services and railroads operating alongside each other. The best case scenario is that there is enough market will to allow a lab to monopolize the market, leaving you with the same problems as today but with even less standing in the way of fraud, like companies just paying for good reviews. The realistic case is that no such testing would happen, just like it was before the FDA.
    - JoshTriplett 3y ago
      > If there were any market incentive whatsoever for that, it would already exist. Consumer Reports already exists. https://www.consumerlab.com/ https://www.consumerlab.com/ exists. And the FDA is part of why there is no market for it. Note, for instance, tat the above-mentioned site reviews supplements, which don't have as many restrictions (and which do very much need these kinds of reviews). > like companies just paying for good reviews That would conflict with "respected review company", and leave an opportunity for a company that doesn't accept any kind of payment.
      - jrajav 3y ago
        What kind of precedent is there for this pattern working successfully, long term, in any industry? 'Review companies' get sabotaged all the time if they were ever reliable at all. I sure wouldn't want to rely on one for medicine I give to my family if it was anything like relying on Yelp for a decent restaurant. I'm not at all convinced that the open market is a valid locale for these incentives - it seems to come with inherent conflict of interest. Maybe it's reasonable for us to agree that some kinds of oversight are worth funding as a society without waiting for incentives to sprout up out of the ground.

soared 3y ago

#3 exists - drug trials occur in hospitals (research hospitals?). My only knowledge is late stage cancer where death is all but a certainty, so they can test new cancer drugs with doctor/patient/etc/drug company consent and oversight. Your ability to enter a trial is largely out of your hands though - if your case fits the conditions for a test you can ask around or your doctor may offer, but plenty of factors can rule you out.

bruce511 3y ago
Taking "no hope" patients into a clinical trial is something of a bad-science dillema. On one hand you have patients either a certain death diagnosis. They'll take anything, they have nothing to lose. From the drug trial point of view its more complex. Your death and side-effects are recorded. It's not great if half the people in a study die. What if 90% die? Adding lots of one type of patient yo one side of a study, without adding similar to the control group, invalidates the whole study. And people who are already "hopeless" may end up masking the good outcomes for people earlier in treatment. Currently there's no mechanism for random unproven drugs to be disseminated outside of a study, but equally its a rare study that wants to add "certain death" candidates to the roster. If we want "hail mary" options in drug administration then we need that to exist outside of nedical studies. And formalising this would be difficult because one senses that moves in this direction would open the door to massive exploitation and profiteering by both snake-oil salesmen and big pharma.