5 ms·

You’re mixing two things: Doesn’t work = efficacy trials Is harmful = safety trials iirc the safety trials come first. A lot of drugs get stalled in efficacy

You’re mixing two things: Doesn’t work = efficacy trials Is harmful = safety trials iirc the safety trials come first. A lot of drugs get stalled in efficacy trials because they might only work for some patients and the sample set is small or poorly chosen. I see no reason to stall drugs that are proven safe, even if they might not be effective for all patients, as long as there is full disclosure and informed consent. Freedom to choose is a good thing.

lightedman 7y ago
"You’re mixing two things:" Being ineffective can be very dangerous as a person taking a drug expecting it to alleviate their condition finds no relief and thus dies from their condition. You did not fully read and comprehend the parent post.
- cobbzilla 7y ago
  Post implied fairly plainly that “doesn’t work == harmful”, is there another way to read that?
- kurthr 7y ago
  While I agree with you... if you take the side of the Medical and Insurance industry, it works great. Money is extracted before they died with a high margin process. The incentive is perverse, but it's real and effective.
nvrspyx 7y ago
FDA approves drugs following Phase III Phase I determines safety. Phase II determines efficacy. Phase III is larger scale, randomized, and blind to give the FDA more information on the range of potential adverse effects and the effectiveness of the drug. FDA is supposed to care about both. The acceptable safety of a drug is relative to the effectiveness of it (i.e. a drug may be more dangerous or have more adverse effects, but it’s deemed “worth it” due to the effectiveness of the drug while of course maintaining a minimum safety risk for all drugs). In other words, both safety and effectiveness are both supposed to be taken as equal halves of the whole by the FDA.
- AnthonyMouse 7y ago
  But you also want to consider alternatives. If you have something which is only effective for a small percentage of people even though it's really dangerous, that may still be worth it as something to use for people for which existing treatments were ineffective and the remaining alternative is certain death. Saving 15% of those people can be better than none.
vkou 7y ago
> I see no reason to stall drugs that are proven safe, even if they might not be effective for all patients, as long as there is full disclosure and informed consent. Freedom to choose is a good thing. I do. For every treatment you are taking, you could have been taking some other treatment that might be more effective. If we have no idea whether or not a drug is more effective than placebo, we should not be administering it.
- jcims 7y ago
  This perspective is very frustrating to me. Why in the world would a sane person take a drug with unproven efficacy when others with proven efficacy are available? However, there are many cases where there is no alternative drug or treatment that has been tested for efficacy, and so you’re stuck with hospice as standard of care. It’s one thing for a doctor to recommend administration of a medication, it’s another thing entirely to make it unavailable for those that are in a position to make the choice for themselves.
  - vkou 7y ago
    > This perspective is very frustrating to me. Why in the world would a sane person take a drug with unproven efficacy when others with proven efficacy are available? Because they don't want the side effects of proven treatments, and they hope that snake oil will help them. If people were rational about their health, homeopathic supplements, and other similar bullshit wouldn't be a billion dollar industry. If you can't prove that your treatment works, you shouldn't be advertising it as a medical treatment. Advertise it as a non-medical non-treatment.

lightedman 7y ago

"You’re mixing two things:" Being ineffective can be very dangerous as a person taking a drug expecting it to alleviate their condition finds no relief and thus dies from their condition. You did not fully read and comprehend the parent post.

cobbzilla 7y ago
Post implied fairly plainly that “doesn’t work == harmful”, is there another way to read that?
kurthr 7y ago
While I agree with you... if you take the side of the Medical and Insurance industry, it works great. Money is extracted before they died with a high margin process. The incentive is perverse, but it's real and effective.

nvrspyx 7y ago

FDA approves drugs following Phase III Phase I determines safety. Phase II determines efficacy. Phase III is larger scale, randomized, and blind to give the FDA more information on the range of potential adverse effects and the effectiveness of the drug. FDA is supposed to care about both. The acceptable safety of a drug is relative to the effectiveness of it (i.e. a drug may be more dangerous or have more adverse effects, but it’s deemed “worth it” due to the effectiveness of the drug while of course maintaining a minimum safety risk for all drugs). In other words, both safety and effectiveness are both supposed to be taken as equal halves of the whole by the FDA.

AnthonyMouse 7y ago
But you also want to consider alternatives. If you have something which is only effective for a small percentage of people even though it's really dangerous, that may still be worth it as something to use for people for which existing treatments were ineffective and the remaining alternative is certain death. Saving 15% of those people can be better than none.

vkou 7y ago

> I see no reason to stall drugs that are proven safe, even if they might not be effective for all patients, as long as there is full disclosure and informed consent. Freedom to choose is a good thing. I do. For every treatment you are taking, you could have been taking some other treatment that might be more effective. If we have no idea whether or not a drug is more effective than placebo, we should not be administering it.

jcims 7y ago
This perspective is very frustrating to me. Why in the world would a sane person take a drug with unproven efficacy when others with proven efficacy are available? However, there are many cases where there is no alternative drug or treatment that has been tested for efficacy, and so you’re stuck with hospice as standard of care. It’s one thing for a doctor to recommend administration of a medication, it’s another thing entirely to make it unavailable for those that are in a position to make the choice for themselves.
- vkou 7y ago
  > This perspective is very frustrating to me. Why in the world would a sane person take a drug with unproven efficacy when others with proven efficacy are available? Because they don't want the side effects of proven treatments, and they hope that snake oil will help them. If people were rational about their health, homeopathic supplements, and other similar bullshit wouldn't be a billion dollar industry. If you can't prove that your treatment works, you shouldn't be advertising it as a medical treatment. Advertise it as a non-medical non-treatment.