4 ms·

Looking at these numbers, I wonder whether the FDA process is a bit too conservative with respect to safety. There were the articles yesterday about diabetics

by cbhl 7y ago

Looking at these numbers, I wonder whether the FDA process is a bit too conservative with respect to safety. There were the articles yesterday about diabetics yesterday creating closed-loop feedback systems out of old insecure parts, because a FDA-certified alternative is decades out. I've heard also of folks joining studies for newer-and-better IUDs that are approved by European regulators, but need to be re-certified for the US market. Politics and lobbying are hard, but would some regulatory changes result in a 10x reduction in R&D costs?

boyband6666 7y ago
Simple answer is probably not; even a lowering of standards you still need to know if it works - so still doing studies. You'd also then get more drugs like Lily's recently that in post-marketing turns out not to work, but ate of half a billion in sales, and a lot of patients who got not benefit. There is no simple easy answer, it's a massively hard problem. The regulators have to balance benefit and risk, and for the most part do a hugely impressive job where they already have to add in judgement.
- gdy 7y ago
  "you still need to know if it works" No, you do not. Just look at the market of dietary supplements.
  - boyband6666 7y ago
    That's actually a very interesting one, and has been written about at length by a number of medical stats people. Hopefully I do them justice to their arguments by saying that the benefits from supplements (if any) are tiny - as in a hazard ratio of death is pretty much 1 unless you are actually deficient. Equally however the potential downside of them is pretty much zero - expensive wee is what they can mostly be summarised as. Whilst they may be money wasted, the're mostly benign, save the odd tragic case. If supplements had the side effects of chemotherapies however, they'd be banned straight away - without evidence of benefit, the risks would be too high. For a more authoratative take, one of my heroes: http://www.dcscience.net/2013/11/18/we-know-little-about-the-effect-of-diet-on-health-thats-why-so-much-is-written-about-it/ http://www.dcscience.net/2013/11/18/we-know-little-about-the...
    - gdy 7y ago
      Potential downside is pretty high if you consider that some people tend to take supplements and other sorts of snake oil instead of working medicine.
bluGill 7y ago
Many people have asked that question, it is a hard complex problem. If the FDA approves a drug and it turns out bad we hate them, if they fail to approve a drug we hate them without knowing if it is worse than nothing. Those old parts work. Is modern technology better? Sometimes yes, but sometime change for the sake of change is bad (I hate modern bathrooms cause the water never comes on, old manual valves worked)
- Symmetry 7y ago
  Generally when the FDA fails to approve a drug nobody outside the industry ever hears about it. It's only in rare cases where you have lethal infections that take a very long time to kill, such as with AIDS, that the FDA faces strong political blowback over non-approvals.
opportune 7y ago
The thing is, the big established pharma companies don't necessarily mind the difficulty in bringing a drug or device to market since it makes competition more difficult. And it's a politically difficult move to support loosening regulations and restrictions here, because some people will inevitably die due to the lower standards, and everyone will remember those dozens/hundreds of people rather than the hundreds of thousands who are able to get new treatments faster
Symmetry 7y ago
Every study I'm aware of that's looked into this issue says that the FDA is too conservative and we'd be better off using the looser systems found in other developed countries. Though it's gotten a lot better over the last few decades, we probably aren't going to get a repeat of the early beta blocker situation where the FDA saved 100s of people from liver failure from early drugs at the cost of 100,000s of excess deaths due to heart failure.
elliekelly 7y ago
Your comment reminded me of the (ridiculous but sadly necessary) "Sunscreen Innovation Act" passed a few years ago.[1] U.S. financial regulators often "vet" their equivalent foreign agencies and whitelist those whose processes are sufficiently analogous and in some cases allow US entities to rely upon the work done in those whitelisted jurisdictions. I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. [1] https://en.wikipedia.org/wiki/Sunscreen_Innovation_Act https://en.wikipedia.org/wiki/Sunscreen_Innovation_Act
- fgonzag 7y ago
  I agree, safety is very important but so is actually getting the drugs to people at prices they can afford. Perfect drugs are still useless if no one can buy them. An international certification, recognized by all the major countries, could work very well
- refurb 7y ago
  I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. The reason is thalidomide. The US was one of the few countries that chose not to approve it despite other countries doing so. Saved a lot of US children from birth defects.
  - elliekelly 7y ago
    Ah yea, thalidomide. That drug is often used to justify poor policy decisions at the FDA. It's the reason the FDA banned women of child bearing age from clinical research.[1] In the late 80's there was even a study conducted to determine the relationship between obesity and risk for breast and uterine cancer. Guess how many women were enrolled? Zero. Thanks to the FDA's misguided knee jerk policy response to thalidomide. It seems to me the FDA's process might "protect" a small number of people but that comes at the expense of many thousands of lives. [1]https://www.drugwatch.com/news/2018/07/25/excluding-women-from-drug-trials-kills-people/ https://www.drugwatch.com/news/2018/07/25/excluding-women-fr...

by cbhl 7y ago

boyband6666 7y ago

Simple answer is probably not; even a lowering of standards you still need to know if it works - so still doing studies. You'd also then get more drugs like Lily's recently that in post-marketing turns out not to work, but ate of half a billion in sales, and a lot of patients who got not benefit. There is no simple easy answer, it's a massively hard problem. The regulators have to balance benefit and risk, and for the most part do a hugely impressive job where they already have to add in judgement.

gdy 7y ago
"you still need to know if it works" No, you do not. Just look at the market of dietary supplements.
- boyband6666 7y ago
  That's actually a very interesting one, and has been written about at length by a number of medical stats people. Hopefully I do them justice to their arguments by saying that the benefits from supplements (if any) are tiny - as in a hazard ratio of death is pretty much 1 unless you are actually deficient. Equally however the potential downside of them is pretty much zero - expensive wee is what they can mostly be summarised as. Whilst they may be money wasted, the're mostly benign, save the odd tragic case. If supplements had the side effects of chemotherapies however, they'd be banned straight away - without evidence of benefit, the risks would be too high. For a more authoratative take, one of my heroes: http://www.dcscience.net/2013/11/18/we-know-little-about-the-effect-of-diet-on-health-thats-why-so-much-is-written-about-it/ http://www.dcscience.net/2013/11/18/we-know-little-about-the...
  - gdy 7y ago
    Potential downside is pretty high if you consider that some people tend to take supplements and other sorts of snake oil instead of working medicine.

bluGill 7y ago

Many people have asked that question, it is a hard complex problem. If the FDA approves a drug and it turns out bad we hate them, if they fail to approve a drug we hate them without knowing if it is worse than nothing. Those old parts work. Is modern technology better? Sometimes yes, but sometime change for the sake of change is bad (I hate modern bathrooms cause the water never comes on, old manual valves worked)

Symmetry 7y ago
Generally when the FDA fails to approve a drug nobody outside the industry ever hears about it. It's only in rare cases where you have lethal infections that take a very long time to kill, such as with AIDS, that the FDA faces strong political blowback over non-approvals.

opportune 7y ago

The thing is, the big established pharma companies don't necessarily mind the difficulty in bringing a drug or device to market since it makes competition more difficult. And it's a politically difficult move to support loosening regulations and restrictions here, because some people will inevitably die due to the lower standards, and everyone will remember those dozens/hundreds of people rather than the hundreds of thousands who are able to get new treatments faster

Symmetry 7y ago

Every study I'm aware of that's looked into this issue says that the FDA is too conservative and we'd be better off using the looser systems found in other developed countries. Though it's gotten a lot better over the last few decades, we probably aren't going to get a repeat of the early beta blocker situation where the FDA saved 100s of people from liver failure from early drugs at the cost of 100,000s of excess deaths due to heart failure.

elliekelly 7y ago

Your comment reminded me of the (ridiculous but sadly necessary) "Sunscreen Innovation Act" passed a few years ago.[1] U.S. financial regulators often "vet" their equivalent foreign agencies and whitelist those whose processes are sufficiently analogous and in some cases allow US entities to rely upon the work done in those whitelisted jurisdictions. I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. [1] https://en.wikipedia.org/wiki/Sunscreen_Innovation_Act https://en.wikipedia.org/wiki/Sunscreen_Innovation_Act

fgonzag 7y ago
I agree, safety is very important but so is actually getting the drugs to people at prices they can afford. Perfect drugs are still useless if no one can buy them. An international certification, recognized by all the major countries, could work very well
refurb 7y ago
I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. The reason is thalidomide. The US was one of the few countries that chose not to approve it despite other countries doing so. Saved a lot of US children from birth defects.
- elliekelly 7y ago
  Ah yea, thalidomide. That drug is often used to justify poor policy decisions at the FDA. It's the reason the FDA banned women of child bearing age from clinical research.[1] In the late 80's there was even a study conducted to determine the relationship between obesity and risk for breast and uterine cancer. Guess how many women were enrolled? Zero. Thanks to the FDA's misguided knee jerk policy response to thalidomide. It seems to me the FDA's process might "protect" a small number of people but that comes at the expense of many thousands of lives. [1]https://www.drugwatch.com/news/2018/07/25/excluding-women-from-drug-trials-kills-people/ https://www.drugwatch.com/news/2018/07/25/excluding-women-fr...