6 ms·

It's not that simple. If they allow the sale of non regulated drugs then you'll have a 10x increase in commercials on TV trying to sell you an untested and unr

by proee 16y ago

It's not that simple. If they allow the sale of non regulated drugs then you'll have a 10x increase in commercials on TV trying to sell you an untested and unregulated "purple pill". The fine print will say "this drug has not been tested and is not approved by the FDA. It may cause death or create an uncontrolled viral outbreak..." The drug will sell like hotcakes though because the commercials will have lots of happy-smiley people and the distributor will get a healthy 80% profit margin on the sales. There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption.

elidourado 16y ago
If that's really your concern, then why not at least let college graduates opt out? Or people holding PhDs? My suspicion is that many people would oppose this because it disadvantages the uneducated, but of course you can't have it both ways. Either regulation is good for the uneducated or it is not.
- eru 16y ago
  > Or people holding PhDs? In which fields? You are entering a mine field. > Either regulation is good for the uneducated or it is not. There could be different kinds of regulation.
xiaoma 16y ago
The US already has that situation in the supplements industry and while heavily-advertised weight-loss/muscle/hair supplements are annoying, it's not that bad. The cost of not getting valuable drugs is underestimated since people only hear about it in rare cases such as this one, whereas dangerous treatments generate a lot of media coverage.
- carbocation 16y ago
  Right, weight loss supplements are OK because hypertension and cardiomyopathy (along with the occasional sudden death) are no problem? At the end of the day, the FDA needs to carefully regulate the market not because dumb people need them to, but because smart people such as most HNers do.
tlrobinson 16y ago
Why not simply prohibit advertising of non-FDA approved drugs?
- staunch 16y ago
  And require a signed waiver and prescription from a doctor? Presumably (most) doctors are smart enough not to prescribe cyanide as a cure for insomnia.
  - megablast 16y ago
    OK, so now the doctor has to come up with the millions of non-FDA approved drugs that are about to come onto the market, because there will be lots of these drugs. Personally, if you are stupid enough to go for the non-FDA approved drugs, you are too stupid to help anyway. Unless you are going by some other approval system, for example whatever they use in Canada, UK or Australia. But if you are just going by what you read on the website, you are a fool.
- psadauskas 16y ago
  If I write a blog post saying I like X non-approved drug, do I get arrested? What if I was paid to do it? Prohibiting advertising strays dangerously close to the 1st Amendment.
  - staunch 16y ago
    Drugs companies were prohibited from advertising on television until not so long ago. There's even a special law: http://en.wikipedia.org/wiki/Prescription_Drug_Marketing_Act_%28PDMA%29 http://en.wikipedia.org/wiki/Prescription_Drug_Marketing_Act...
    - roboneal 16y ago
      Arguably, that is the crux of the 1st Amendment issue -- government regulation of speech - including that of "evil" or "unpopular" drug companies -- is a slippery slope.
barry-cotter 16y ago
There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption. What's so awesome about non-profits? They have their very own perverse incentive structures. Proposed replacement or supplement: Any company wishing to sell Drug X to the public must be insured against patient lawsuits. Insurance companies are quite capable of hiring people to assess risk and wouldn't have the same biased weighting of risk and benefit. Why not make getting these non-approved drugs conditional on getting X% of the questions on a MCT correct, where said test is a quiz on the effects, side-effects, toxicity etc. of the desired drug? If I was implementing this I'd mandate that the source material for said test be publicly available at a centralised registry, that you need to get 100% of the answers right that the questions be randomly drawn from a test bank and that the test cost say half a day's median wage. Have authorisation lapse after three months so you need to take the test again. Informed consent has just been assured, and people can now make their own decisions but they need to really want the drug.
- Groxx 16y ago
  What's so awesome about non-profits? They have their very own perverse incentive structures. I wonder the same thing. And it's not like the people in the non-profit agencies aren't paid, and can't accept bribes. Not that anyone bribes the FDA, of course. They're non-profit, what possible gain could there be?
  - yardie 16y ago
    FDA is a federal agency, paid for by the government. It is not a nonprofit because it doesn't have to seek funding whatever the govt't gives it is what it works with. BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison.
    - lionhearted 16y ago
      > BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison. If bribed with cash, maybe, unless it can fall under "campaign finance". Sports tickets, dinners, and gifts are generally accepted though.
matwood 16y ago
"There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption." You're kidding right? At least with a for profit corporation I know their motives. With a government agency I have no idea if they are returning a favor, taking money, or simply like the person. With that said, the FDA still requires a large profit motive since no one would spend the millions required to get approved unless they expected some return. I wonder how many possible working drugs for esoteric diseases are floating around that will never be released because of the expense of getting through the FDA.
- tome 16y ago
  Could you please clarify what it is about for-profits that makes you think they would never accept bribes?
  - matwood 16y ago
    That's the thing, I fully expect for-profits to accept bribes and would act accordingly. Assuming that the FDA is some high and mighty agency that only approves safe drugs is the problem.
    - infinite8s 16y ago
      What do you mean you would act accordingly? You would ignore any recommendations they make? So then you are left trusting the original drug developer to have properly done and analyzed the safety trials?
pwim 16y ago
Allowing advertising for drugs is a problem in and of itself. I think the United States is pretty unique in allowing direct to consumer drug advertisement.
- s3graham 16y ago
  I always find watching US tv bizarre because of that. You have all the usual crap car/cellphone/food ads and then all of a sudden they're diving into surreal craziness about cholesterol levels and brain chemistry that I suspect 99%+ of viewers can't possibly critically evaluate.
Groxx 16y ago
And when people finally quit looking at medication as a cure-all, because we've had the FDA around to "prove" things are safe? Of course, they've never made mistakes, oh no, not them. Approved medications aren't dangerous in the least degree. And no "medications" are sold which aren't FDA approved. Not supplements, not energy drinks, nothing. McD's approves their fries, so does your corner diner. I think the solution may be to have multiple standards bodies, the FDA being one of them. If bodies A, B, and Q approve a drug, and they have a good track record, people can choose. If a drug is experimental, bodies X and Y agree with research Z and not Q because someone ate a peanut, so take your pick based on your circumstances. At least then there would be other options.
artsrc 16y ago
There is a non-profit agency that looked into the safety of the drug in Mexico. The FDA should have a rule that any drug approved by any of the following agencies is automatically approved for use in the USA.

by proee 16y ago

elidourado 16y ago

If that's really your concern, then why not at least let college graduates opt out? Or people holding PhDs? My suspicion is that many people would oppose this because it disadvantages the uneducated, but of course you can't have it both ways. Either regulation is good for the uneducated or it is not.

eru 16y ago
> Or people holding PhDs? In which fields? You are entering a mine field. > Either regulation is good for the uneducated or it is not. There could be different kinds of regulation.

xiaoma 16y ago

The US already has that situation in the supplements industry and while heavily-advertised weight-loss/muscle/hair supplements are annoying, it's not that bad. The cost of not getting valuable drugs is underestimated since people only hear about it in rare cases such as this one, whereas dangerous treatments generate a lot of media coverage.

carbocation 16y ago
Right, weight loss supplements are OK because hypertension and cardiomyopathy (along with the occasional sudden death) are no problem? At the end of the day, the FDA needs to carefully regulate the market not because dumb people need them to, but because smart people such as most HNers do.

tlrobinson 16y ago

Why not simply prohibit advertising of non-FDA approved drugs?

staunch 16y ago
And require a signed waiver and prescription from a doctor? Presumably (most) doctors are smart enough not to prescribe cyanide as a cure for insomnia.
- megablast 16y ago
  OK, so now the doctor has to come up with the millions of non-FDA approved drugs that are about to come onto the market, because there will be lots of these drugs. Personally, if you are stupid enough to go for the non-FDA approved drugs, you are too stupid to help anyway. Unless you are going by some other approval system, for example whatever they use in Canada, UK or Australia. But if you are just going by what you read on the website, you are a fool.
psadauskas 16y ago
If I write a blog post saying I like X non-approved drug, do I get arrested? What if I was paid to do it? Prohibiting advertising strays dangerously close to the 1st Amendment.
- staunch 16y ago
  Drugs companies were prohibited from advertising on television until not so long ago. There's even a special law: http://en.wikipedia.org/wiki/Prescription_Drug_Marketing_Act_%28PDMA%29 http://en.wikipedia.org/wiki/Prescription_Drug_Marketing_Act...
  - roboneal 16y ago
    Arguably, that is the crux of the 1st Amendment issue -- government regulation of speech - including that of "evil" or "unpopular" drug companies -- is a slippery slope.

barry-cotter 16y ago

There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption. What's so awesome about non-profits? They have their very own perverse incentive structures. Proposed replacement or supplement: Any company wishing to sell Drug X to the public must be insured against patient lawsuits. Insurance companies are quite capable of hiring people to assess risk and wouldn't have the same biased weighting of risk and benefit. Why not make getting these non-approved drugs conditional on getting X% of the questions on a MCT correct, where said test is a quiz on the effects, side-effects, toxicity etc. of the desired drug? If I was implementing this I'd mandate that the source material for said test be publicly available at a centralised registry, that you need to get 100% of the answers right that the questions be randomly drawn from a test bank and that the test cost say half a day's median wage. Have authorisation lapse after three months so you need to take the test again. Informed consent has just been assured, and people can now make their own decisions but they need to really want the drug.

Groxx 16y ago
What's so awesome about non-profits? They have their very own perverse incentive structures. I wonder the same thing. And it's not like the people in the non-profit agencies aren't paid, and can't accept bribes. Not that anyone bribes the FDA, of course. They're non-profit, what possible gain could there be?
- yardie 16y ago
  FDA is a federal agency, paid for by the government. It is not a nonprofit because it doesn't have to seek funding whatever the govt't gives it is what it works with. BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison.
  - lionhearted 16y ago
    > BTW, bribing a government official will usually result in one or both of you doing time in a federal (not a country club) prison. If bribed with cash, maybe, unless it can fall under "campaign finance". Sports tickets, dinners, and gifts are generally accepted though.

matwood 16y ago

"There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption." You're kidding right? At least with a for profit corporation I know their motives. With a government agency I have no idea if they are returning a favor, taking money, or simply like the person. With that said, the FDA still requires a large profit motive since no one would spend the millions required to get approved unless they expected some return. I wonder how many possible working drugs for esoteric diseases are floating around that will never be released because of the expense of getting through the FDA.

tome 16y ago
Could you please clarify what it is about for-profits that makes you think they would never accept bribes?
- matwood 16y ago
  That's the thing, I fully expect for-profits to accept bribes and would act accordingly. Assuming that the FDA is some high and mighty agency that only approves safe drugs is the problem.
  - infinite8s 16y ago
    What do you mean you would act accordingly? You would ignore any recommendations they make? So then you are left trusting the original drug developer to have properly done and analyzed the safety trials?

pwim 16y ago

Allowing advertising for drugs is a problem in and of itself. I think the United States is pretty unique in allowing direct to consumer drug advertisement.

s3graham 16y ago
I always find watching US tv bizarre because of that. You have all the usual crap car/cellphone/food ads and then all of a sudden they're diving into surreal craziness about cholesterol levels and brain chemistry that I suspect 99%+ of viewers can't possibly critically evaluate.

Groxx 16y ago

And when people finally quit looking at medication as a cure-all, because we've had the FDA around to "prove" things are safe? Of course, they've never made mistakes, oh no, not them. Approved medications aren't dangerous in the least degree. And no "medications" are sold which aren't FDA approved. Not supplements, not energy drinks, nothing. McD's approves their fries, so does your corner diner. I think the solution may be to have multiple standards bodies, the FDA being one of them. If bodies A, B, and Q approve a drug, and they have a good track record, people can choose. If a drug is experimental, bodies X and Y agree with research Z and not Q because someone ate a peanut, so take your pick based on your circumstances. At least then there would be other options.

artsrc 16y ago

There is a non-profit agency that looked into the safety of the drug in Mexico. The FDA should have a rule that any drug approved by any of the following agencies is automatically approved for use in the USA.