4 ms·

That's true, but there are also many drugs on the market which are barely better than a placebo, or even more harmful than no medication. However, they are stil

That's true, but there are also many drugs on the market which are barely better than a placebo, or even more harmful than no medication. However, they are still prescribed and billed for as if they are effective.

refurb 10y ago
Have any examples? The FDA won't approve a drug unless safety and efficacy have been proven.
- Broken_Hippo 10y ago
  Over the counter cough syrup is a weird category. It is an old drug, and some of the studies are mixed. The FDA regulations weren't the same back then, and so it still has the approval. It has some issues when kids take a whole bottle, which means some places restrict its sale - but overall, it hasn't proved harmful to folks either. Cough drops are another one. There isn't much evidence they make you breathe better, yet people report that they do. They think this is likely due to the reaction menthol has on mucus membranes - it feels cool on the air one is breathing so they feel their breath. Yet, menthol is considered a drug and as such, it must have an FDA approval. Edit: I know these aren't prescription, but they were the first ones I thought of.
- code_duck 10y ago
  Unfortunately that process is a lot more complex than one might think, like everything else involving medicine, government, or even worse, a combination of the two. Safety and efficacy are not a binary condition, either. Questions you might ask are, how effective does a drug have to be to be approved? Is it better to have false positives or false negatives? Who pays for and conducts the studies, and who reviews them? How many FDA officials used to work for or lobby for the companies they are regulating? There are many drugs withdrawn for the reasons I mentioned - ineffectiveness or harm. While I don't personally maintain a handy list of links to articles about this topic, this list contains many drugs that were withdrawn from the market for the reasons mentioned: https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs First thing I clicked on: https://en.m.wikipedia.org/wiki/Indoprofen https://en.m.wikipedia.org/wiki/Indoprofen Withdrawn for causing severe gastrointestinal bleeding
  - refurb 10y ago
    Every drug is approved based on a risk vs. benefit analysis. The FDA can't know exactly what will happen when the drug is approved since you can't test a drug on every patient prior to approval (that would be unethical). No one should be surprised when a few drugs are pulled off the market post-launch. I would argue the FDA didn't make a mistake here and the system works.
    - code_duck 10y ago
      All I was asserting was my original statement. Many drugs are on the market which are ineffective or harmful. As far as your conclusion there, like your other question it's dramatically over simplified. Whether it 'works' or not seems like a judgement so binary as to be useless. How well it works depends on many factors that we haven't discussed at all.

refurb 10y ago

Have any examples? The FDA won't approve a drug unless safety and efficacy have been proven.

Broken_Hippo 10y ago
Over the counter cough syrup is a weird category. It is an old drug, and some of the studies are mixed. The FDA regulations weren't the same back then, and so it still has the approval. It has some issues when kids take a whole bottle, which means some places restrict its sale - but overall, it hasn't proved harmful to folks either. Cough drops are another one. There isn't much evidence they make you breathe better, yet people report that they do. They think this is likely due to the reaction menthol has on mucus membranes - it feels cool on the air one is breathing so they feel their breath. Yet, menthol is considered a drug and as such, it must have an FDA approval. Edit: I know these aren't prescription, but they were the first ones I thought of.
code_duck 10y ago
Unfortunately that process is a lot more complex than one might think, like everything else involving medicine, government, or even worse, a combination of the two. Safety and efficacy are not a binary condition, either. Questions you might ask are, how effective does a drug have to be to be approved? Is it better to have false positives or false negatives? Who pays for and conducts the studies, and who reviews them? How many FDA officials used to work for or lobby for the companies they are regulating? There are many drugs withdrawn for the reasons I mentioned - ineffectiveness or harm. While I don't personally maintain a handy list of links to articles about this topic, this list contains many drugs that were withdrawn from the market for the reasons mentioned: https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs https://en.m.wikipedia.org/wiki/List_of_withdrawn_drugs First thing I clicked on: https://en.m.wikipedia.org/wiki/Indoprofen https://en.m.wikipedia.org/wiki/Indoprofen Withdrawn for causing severe gastrointestinal bleeding
- refurb 10y ago
  Every drug is approved based on a risk vs. benefit analysis. The FDA can't know exactly what will happen when the drug is approved since you can't test a drug on every patient prior to approval (that would be unethical). No one should be surprised when a few drugs are pulled off the market post-launch. I would argue the FDA didn't make a mistake here and the system works.
  - code_duck 10y ago
    All I was asserting was my original statement. Many drugs are on the market which are ineffective or harmful. As far as your conclusion there, like your other question it's dramatically over simplified. Whether it 'works' or not seems like a judgement so binary as to be useless. How well it works depends on many factors that we haven't discussed at all.