5 ms·

> So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Real

by ccleve 10y ago

> So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really? Yes, if the process is so rigorous and expensive that it drives the cost of drugs beyond the reach of people who need them, and it hampers the effective functioning of the free market. And I think it's widely accepted that's far more expensive to bring a drug to market here than it is elsewhere in the world. The FDA believes its mission should be to ensure that drugs are safe and effective. That is wrongheaded. Instead, it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit? In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug. There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life. It is offensive that the FDA thinks it should get in the way of the distribution of such things. I was in Colorado last summer and took my son horseback riding. Our tour guide was allergic to bee stings, but she was just scraping by financially, and couldn't afford an Epipen. She'd been stung before, and her throat had tightened, but fortunately she happened to have an old, expired pen from before the price went up and so she survived. But now she was going out bare. We gave her one my son's pens. It won't last long. It's possible that she won't last long either. You want evidence this is an evil system? There it is.

bottled_poe 10y ago
> it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit? Do you really believe the FDA isn't doing this? The price of these drugs is directly linked with the risk*cost of being sued. In order to reduce the cost of the drugs, we need to reduce the benefits of suing, but this will undoubtably upset libertarians. Can't please everyone.
- hackuser 10y ago
  > The price of these drugs is directly linked with the risk*cost of being sued Generally, prices are set to whatever will maximize profit. In the 'free market', nobody with any sophistication prices things based on cost. It's a fundamental of microeconomics.
DSMan195276 10y ago
I don't really think you know all the history here. There are other companies who have/are attempting to create competitors to EpiPen. A few of them weren't able to get passed by the FDA, and one of them passed the FDA in 2012 but was recalled because of the product misfiring. The EpiPen problem seems to be much less an FDA problem then it is a problem with manufacturing, other companies don't seem to be able to make products that work nearly as well as EpiPen. If the FDA wasn't in the picture, you would still have the problem that there aren't any other reliable replacements for EpiPen even though companies have tried. IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ with a 100% success rate, or the one that's 100$ with a 95% success rate?". That sounds like a pretty bleak state of affairs, and could easily encourage cutting corners to cut costs. "How much does a death cost us?"
- derekp7 10y ago
  What about buying 5 of them that are $20 bucks a piece? Maybe they can be made in a stackable format, so it would be easy to carry 5 of them. If one misfires, snap it off and use the next one in the stack.
  - DSMan195276 10y ago
    That only works if you can actually tell if it misfired or not - if you're administering it to someone else, you may simply not be able to. With that, part of the problem was that the misfires would deliver some of the drug but not all, and only sometimes would completely fail to deliver any of the drug. Telling if you got 50% vs. 100% would probably be tough - and even if you could, if you took two because the first gave you 50%, you might end-up getting a big overdose or still get an underdose. So having multiple of those pens really just doesn't solve the problem if the pens themselves are unreliable.
rtkwe 10y ago
> a $10 bottle of epinephrine and a $1 syringe can save a life You're not prevented from using that method and some people and a lot of emergency services (that have relevant training) do. There are problems with that too though, epinephrine isn't completely stable and properly injecting when you or someone you know needs the shot isn't an easy task. What the FDA is and should prevent are devices like the Auvi-Q that couldn't inject the proper amount reliably.
snowwrestler 10y ago
> In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug. Well one risk is that you'll jam the thing into your thigh and get no epinephrine, because the injection mechanism failed. If this happened to your son, and he died, would you take that outcome serenely? This is what the FDA is trying to prevent. > There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life. Then buy the bottle and syringe. The FDA is not, to my knowledge, preventing people from doing so. It's not as easy or reliable as an auto-injector, but it's also a lot cheaper, so it seems the system is already providing an alternative. There is also at least one other auto-injector on the market besides EpiPen. Again--not as easy to use, but cheaper.

by ccleve 10y ago

bottled_poe 10y ago

> it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit? Do you really believe the FDA isn't doing this? The price of these drugs is directly linked with the risk*cost of being sued. In order to reduce the cost of the drugs, we need to reduce the benefits of suing, but this will undoubtably upset libertarians. Can't please everyone.

hackuser 10y ago
> The price of these drugs is directly linked with the risk*cost of being sued Generally, prices are set to whatever will maximize profit. In the 'free market', nobody with any sophistication prices things based on cost. It's a fundamental of microeconomics.

DSMan195276 10y ago

I don't really think you know all the history here. There are other companies who have/are attempting to create competitors to EpiPen. A few of them weren't able to get passed by the FDA, and one of them passed the FDA in 2012 but was recalled because of the product misfiring. The EpiPen problem seems to be much less an FDA problem then it is a problem with manufacturing, other companies don't seem to be able to make products that work nearly as well as EpiPen. If the FDA wasn't in the picture, you would still have the problem that there aren't any other reliable replacements for EpiPen even though companies have tried. IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ with a 100% success rate, or the one that's 100$ with a 95% success rate?". That sounds like a pretty bleak state of affairs, and could easily encourage cutting corners to cut costs. "How much does a death cost us?"

derekp7 10y ago
What about buying 5 of them that are $20 bucks a piece? Maybe they can be made in a stackable format, so it would be easy to carry 5 of them. If one misfires, snap it off and use the next one in the stack.
- DSMan195276 10y ago
  That only works if you can actually tell if it misfired or not - if you're administering it to someone else, you may simply not be able to. With that, part of the problem was that the misfires would deliver some of the drug but not all, and only sometimes would completely fail to deliver any of the drug. Telling if you got 50% vs. 100% would probably be tough - and even if you could, if you took two because the first gave you 50%, you might end-up getting a big overdose or still get an underdose. So having multiple of those pens really just doesn't solve the problem if the pens themselves are unreliable.

rtkwe 10y ago

> a $10 bottle of epinephrine and a $1 syringe can save a life You're not prevented from using that method and some people and a lot of emergency services (that have relevant training) do. There are problems with that too though, epinephrine isn't completely stable and properly injecting when you or someone you know needs the shot isn't an easy task. What the FDA is and should prevent are devices like the Auvi-Q that couldn't inject the proper amount reliably.

snowwrestler 10y ago

> In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug. Well one risk is that you'll jam the thing into your thigh and get no epinephrine, because the injection mechanism failed. If this happened to your son, and he died, would you take that outcome serenely? This is what the FDA is trying to prevent. > There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life. Then buy the bottle and syringe. The FDA is not, to my knowledge, preventing people from doing so. It's not as easy or reliable as an auto-injector, but it's also a lot cheaper, so it seems the system is already providing an alternative. There is also at least one other auto-injector on the market besides EpiPen. Again--not as easy to use, but cheaper.