5 ms·

Not that it’s relevant in this particular case, but I don’t take anything that’s only approved in the US, because the FDA really doesn’t care, and especially do

Not that it’s relevant in this particular case, but I don’t take anything that’s only approved in the US, because the FDA really doesn’t care, and especially doesn’t care right now. Most drug companies actually view the US as the beta test country in a lot of ways. If something makes it to Australia (who are very strict on pharmaceuticals) then it’s usually pretty safe.

refurb 6y ago
As someone who has worked directly with the FDA, this is an absurd position. If anything, the FDA errs on the side of causing no harm versus getting a much needed treatment approved. And it might be good to know that most countries approve drugs based on the same data - global clinical trials. Australia is looking at the same data as the US when making an approval decision. Some countries require local trials (China and India, I believe). In addition, there is plenty of collaboration across drug approval bodies when developing or changing regulations. They are all talking to each other to determine the best approach. Here is a good example of the FDA and TGA (Australia) and Canada approving a new cancer drug together[1] [1] https://www.fdanews.com/articles/192766-fda-approves-first-cancer-drugs-in-collaboration-with-tga-and-health-canada?v=preview https://www.fdanews.com/articles/192766-fda-approves-first-c...
- jdietrich 6y ago
  Several aspects of FDA regulation are widely regarded as inadequate, in particular the 510(k) process for medical devices and Section 901 of the FDASIA. FDA approval is slow and expensive, but the political pressure to change that situation has created myriad alternative routes to market authorisation rather than a fundamental reform of the process. Far too many drugs and devices have sneaked onto the market with lower standards of scrutiny and the FDA's post-marketing surveillance isn't up to the task. The FDA knew about rofecoxib's cardiovascular risks for years and did nothing; they've known about rosiglitazone for years and they've done very little. It's just too easy for bad products to get on the market and stay on the market under the FDA's less-than-vigilant gaze.
  - refurb 6y ago
    Several aspects of FDA regulation are widely regarded as inadequate I think that's a matter of opinion, rather than a purely factual statement. It intersects with your comment "Far too many drugs and devices have sneaked onto the market with lower standards of scrutiny", because it begs the question "how many is too many?". It's all a trade-off. The higher level of scrutiny requires more time and more money and can result in people being denied drugs that could have prevented harm or death. It's my own personal opinion, but I think the FDA does a pretty good job considering the judgements they are asked to make. And rofecoxib was eventually pulled, but only after careful scrutiny of the risk. It's not hard to do a retrospective analysis and see a safety signal. Pulling a product based on limited data means you may be doing harm by denying people a drug that helps them. Before the COX2s existed, perforated ulcers due to NSAID use weren't exactly rare. And I'll just end with one final comment - overseeing a safe and effective drug supply is really damn hard. So I try and take that into consideration when evaluating the FDA's (or any countries drug agency) actions.
- grawprog 6y ago
  https://www.nytimes.com/2018/12/28/well/eat/food-additives-banned-europe-united-states.html https://www.nytimes.com/2018/12/28/well/eat/food-additives-b... https://abcnews.go.com/Lifestyle/Food/11-foods-banned-us/story?id=19457237 https://abcnews.go.com/Lifestyle/Food/11-foods-banned-us/sto... http://www.safecosmetics.org/get-the-facts/regulations/international-laws/ http://www.safecosmetics.org/get-the-facts/regulations/inter...
Alex3917 6y ago
> I don’t take anything that’s only approved in the US, because the FDA really doesn’t care, and especially doesn’t care right now. Alternatively, just don't take anything where the patent hasn't expired. Once the patent has been expired for a few years you'll actually get the truth about the dangers of the drug, because the pharma companies then need to make the old drugs look dangerous in comparison to the new ones. (E.g. why they're publishing fake data about hydroxychloroquine in Lancet and elsewhere.)
- ponker 6y ago
  Just taking a hard pass on all pharmaceuticals developed in the last 20 years is not a highly optimized strategy.
  - Alex3917 6y ago
    I mean if you are going to potentially die otherwise then that's one thing. But if you go to the doctor with a sore throat and they hand you some random script for something you've never heard of, hard pass is a pretty good strategy. The appropriate way to make medical decisions is based on data, but if a drug is still under patent then the data isn't there.
    - ChrisLomont 6y ago
      So the day a patent expires the data suddenly appears?
  - new2628 6y ago
    You are right, 50 years is probably smarter, 20 is too little for all the effects to come out.
    - ponker 6y ago
      yep... waiting until 2010 to get vaccinated against measles definitely says “high IQ”
s1artibartfast 6y ago
In my experience, drugs are approved in the US first and foremost because it is the most lucrative market.
centimeter 6y ago
> Most drug companies actually view the US as the beta test country in a lot of ways. This is mostly wrong, except maybe for vaccines. The EMA, for example, has vastly lower regulatory requirements for most drugs than the FDA. Many sources actually estimate that, on net, the FDA has killed more people than it's saved simply by excessively delaying the availability of new drugs in the US. Vaccines go through a different process in the US than most drugs, where the vaccine manufacturers self-certify the safety of their drugs and send a report to the FDA, who either signs off on the certification or doesn't. But the FDA doesn't manage any of the trials, unlike with other drugs. Vaccine manufacturers are also more protected from liability than other kinds of drug manufacturers, via the NVICP. If a non-vaccine drug is approved first in the US, it's almost certainly because the drug is expensive to manufacture and the only country where the manufacturer can expect to break even (at least at first) is the US.
bitcurious 6y ago
> Most drug companies actually view the US as the beta test country in a lot of ways. This has more to do with the fact that if you can’t sell it in the US you’re not making any money off of it. The US is a vital market for novel drugs.

refurb 6y ago

As someone who has worked directly with the FDA, this is an absurd position. If anything, the FDA errs on the side of causing no harm versus getting a much needed treatment approved. And it might be good to know that most countries approve drugs based on the same data - global clinical trials. Australia is looking at the same data as the US when making an approval decision. Some countries require local trials (China and India, I believe). In addition, there is plenty of collaboration across drug approval bodies when developing or changing regulations. They are all talking to each other to determine the best approach. Here is a good example of the FDA and TGA (Australia) and Canada approving a new cancer drug together[1] [1] https://www.fdanews.com/articles/192766-fda-approves-first-cancer-drugs-in-collaboration-with-tga-and-health-canada?v=preview https://www.fdanews.com/articles/192766-fda-approves-first-c...

jdietrich 6y ago
Several aspects of FDA regulation are widely regarded as inadequate, in particular the 510(k) process for medical devices and Section 901 of the FDASIA. FDA approval is slow and expensive, but the political pressure to change that situation has created myriad alternative routes to market authorisation rather than a fundamental reform of the process. Far too many drugs and devices have sneaked onto the market with lower standards of scrutiny and the FDA's post-marketing surveillance isn't up to the task. The FDA knew about rofecoxib's cardiovascular risks for years and did nothing; they've known about rosiglitazone for years and they've done very little. It's just too easy for bad products to get on the market and stay on the market under the FDA's less-than-vigilant gaze.
- refurb 6y ago
  Several aspects of FDA regulation are widely regarded as inadequate I think that's a matter of opinion, rather than a purely factual statement. It intersects with your comment "Far too many drugs and devices have sneaked onto the market with lower standards of scrutiny", because it begs the question "how many is too many?". It's all a trade-off. The higher level of scrutiny requires more time and more money and can result in people being denied drugs that could have prevented harm or death. It's my own personal opinion, but I think the FDA does a pretty good job considering the judgements they are asked to make. And rofecoxib was eventually pulled, but only after careful scrutiny of the risk. It's not hard to do a retrospective analysis and see a safety signal. Pulling a product based on limited data means you may be doing harm by denying people a drug that helps them. Before the COX2s existed, perforated ulcers due to NSAID use weren't exactly rare. And I'll just end with one final comment - overseeing a safe and effective drug supply is really damn hard. So I try and take that into consideration when evaluating the FDA's (or any countries drug agency) actions.
grawprog 6y ago
https://www.nytimes.com/2018/12/28/well/eat/food-additives-banned-europe-united-states.html https://www.nytimes.com/2018/12/28/well/eat/food-additives-b... https://abcnews.go.com/Lifestyle/Food/11-foods-banned-us/story?id=19457237 https://abcnews.go.com/Lifestyle/Food/11-foods-banned-us/sto... http://www.safecosmetics.org/get-the-facts/regulations/international-laws/ http://www.safecosmetics.org/get-the-facts/regulations/inter...

Alex3917 6y ago

> I don’t take anything that’s only approved in the US, because the FDA really doesn’t care, and especially doesn’t care right now. Alternatively, just don't take anything where the patent hasn't expired. Once the patent has been expired for a few years you'll actually get the truth about the dangers of the drug, because the pharma companies then need to make the old drugs look dangerous in comparison to the new ones. (E.g. why they're publishing fake data about hydroxychloroquine in Lancet and elsewhere.)

ponker 6y ago
Just taking a hard pass on all pharmaceuticals developed in the last 20 years is not a highly optimized strategy.
- Alex3917 6y ago
  I mean if you are going to potentially die otherwise then that's one thing. But if you go to the doctor with a sore throat and they hand you some random script for something you've never heard of, hard pass is a pretty good strategy. The appropriate way to make medical decisions is based on data, but if a drug is still under patent then the data isn't there.
  - ChrisLomont 6y ago
    So the day a patent expires the data suddenly appears?
- new2628 6y ago
  You are right, 50 years is probably smarter, 20 is too little for all the effects to come out.
  - ponker 6y ago
    yep... waiting until 2010 to get vaccinated against measles definitely says “high IQ”

s1artibartfast 6y ago

In my experience, drugs are approved in the US first and foremost because it is the most lucrative market.

centimeter 6y ago

> Most drug companies actually view the US as the beta test country in a lot of ways. This is mostly wrong, except maybe for vaccines. The EMA, for example, has vastly lower regulatory requirements for most drugs than the FDA. Many sources actually estimate that, on net, the FDA has killed more people than it's saved simply by excessively delaying the availability of new drugs in the US. Vaccines go through a different process in the US than most drugs, where the vaccine manufacturers self-certify the safety of their drugs and send a report to the FDA, who either signs off on the certification or doesn't. But the FDA doesn't manage any of the trials, unlike with other drugs. Vaccine manufacturers are also more protected from liability than other kinds of drug manufacturers, via the NVICP. If a non-vaccine drug is approved first in the US, it's almost certainly because the drug is expensive to manufacture and the only country where the manufacturer can expect to break even (at least at first) is the US.

bitcurious 6y ago

> Most drug companies actually view the US as the beta test country in a lot of ways. This has more to do with the fact that if you can’t sell it in the US you’re not making any money off of it. The US is a vital market for novel drugs.