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> If the drugs had no effect, then why are people (ab)using drugs like Adderall to improve cognition, etc? You're making an assumption here -- that people's tr

by lutusp 13y ago

> If the drugs had no effect, then why are people (ab)using drugs like Adderall to improve cognition, etc? You're making an assumption here -- that people's trust in, and use of, drugs argues that it's not a mere placebo effect. But there are any number of accounts of people persuading themselves that a drug is reliable, for a drug that is in fact a placebo. In fact, that's how the placebo effect is defined. The only way to sort out these issues is with a double-blind prospective trial. Unfortunately, such trials are nearly nonexistent for this class of drugs, and those trials that have been conducted, are often run badly or published in very selective ways, creating the impression that the drugs are more effective than they really are. Reference (PDF warning): http://alphachoices.com/repository/assets/pdf/EmperorsNewDrugs.pdf http://alphachoices.com/repository/assets/pdf/EmperorsNewDru...

refurb 13y ago
Whoa, wait a second here. Your reference article is arguing that there isn't any difference between these drugs and placebos, so by definition it was a "placebo controlled trial". To say that "double-blind prospective trials are nearly non-existent" is very wrong. Unless you are referring to very old psychiatric drugs, most of them have gone through such trials. There was a lot of disagreement about the paper you referenced. CNS drug are notoriously hard to get positive clinical trial data for. The reasons are: (1) placebo effect is notoriously difficult to control for in psychiatric trials, (2) the clinical trial endpoints are very blunt measures of efficacy. But you know what? That's the best we have right now. There certainly is a strong requirement for efficacy in psychiatric drugs as evidenced by how many have failed to get approved by the FDA. The sad thing is that most big drug companies have completely pulled out of doing R&D for new CNS drugs. They are just too hard to get approved. The end result is that patients with psychiatric illnesses will end up with fewer treatments options unless this changes.
- lutusp 13y ago
  > To say that "double-blind prospective trials are nearly non-existent" is very wrong. You need to read each word and think about it. In a prospective trial, subjects are chosen in advance, they aren't drawn from an existing population of people who have already decided to seek psychological help. A "double-blind, prospective trial" would have to sign people up from a cross-section of the population who have no interest in, or association with, psychological treatments. Then they would be divided into two groups. One group would receive the drug under test, the other would receive a placebo. And the trial would have to be designed so that the two groups wold not be able to tell to which group they belonged. Unfortunately, about the drugs under test, most of them have side effects, which means the subjects aren't blinded (the placebo group have no problem realizing who they are). Even will all its defects and shortcomings, what I have just described is unheard of in psychological testing. > Unless you are referring to very old psychiatric drugs, most of them have gone through such trials. Absolutely false. The kind of design I am describing is simply unheard of. Most trials are of self-selected psychological treatment clients, and it's not uncommon for the "control group" to be what are euphemistically called "no-treatment controls". Guess what that means -- it means the experimental group is compared to people who are told to go home with no treatment and no sham treatment. > There was a lot of disagreement about the paper you referenced. Yes, of course -- and that's the way it should be. But there have been enough similar studies and meta-analyses that the outcome is not in question. > But you know what? That's the best we have right now. Different topic. > There certainly is a strong requirement for efficacy in psychiatric drugs as evidenced by how many have failed to get approved by the FDA. Most of the drugs that just were proven ineffective were not ever tested for efficacy as psychological drugs, they were prescribed off-label -- they were originally approved for some other purpose. > The end result is that patients with psychiatric illnesses will end up with fewer treatments options unless this changes. If the treatments were effective, that would be a shame. But they aren't, so it isn't.
  - cdjk 13y ago
    Prospective study was probably not the correct term, since that's an epidemiological study. "Placebo controlled study" is probably a better term. And a placebo controlled study is the best evidence for a medical treatment - doing epidemiological studies to determine medication effectiveness doesn't seem right. Consider an SSRI study for depression. I want to know if someone who is depressed and takes it does better thank someone who is depressed and doesn't take it, or takes a different drug. I don't care what it does in a healthy population, since they probably won't be taking it. I mean, the effects of SSRIs in healthy individuals is an interesting topic, but not relevant if I'm investigating depression treatments.
    - lutusp 13y ago
      > And a placebo controlled study is the best evidence for a medical treatment ... Yes, and with respect to the drugs we're talking about, subsequent meta-analyses show that the original studies were all biased in favor of their sponsors and all the drugs produce the same results, which argues for a massive placebo effect. For years, studies were published that appeared to support various drug approaches to mental illness, but those studies have been invalidated by more careful analysis that included (as just one well-known example) unpublished studies that came to conclusions not favorable to the drug companies' outlook. > Consider an SSRI study for depression. Yes, let's do that. As things stand right now, studies of drugs that increase serotonin levels show the same effects as those drugs that decrease serotonin levels. This causes open-minded scientists to doubt the efficacy of this entire approach. Reference: http://www.newyorker.com/online/blogs/elements/2013/09/psychiatry-prozac-ssri-mental-health-theory-discredited.html http://www.newyorker.com/online/blogs/elements/2013/09/psych... Quote: "While S.S.R.I.s surely alter serotonin metabolism, those changes do not explain why the drugs work, nor do they explain why they have proven to be no more effective than placebos in clinical trials." > I mean, the effects of SSRIs in healthy individuals is an interesting topic, but not relevant if I'm investigating depression treatments. Such studies -- with the diagnosed depressed -- show no clinically significant result that can distinguish the outcome from the placebo effect. Those are the facts.
      - 13y ago

by lutusp 13y ago

refurb 13y ago

Whoa, wait a second here. Your reference article is arguing that there isn't any difference between these drugs and placebos, so by definition it was a "placebo controlled trial". To say that "double-blind prospective trials are nearly non-existent" is very wrong. Unless you are referring to very old psychiatric drugs, most of them have gone through such trials. There was a lot of disagreement about the paper you referenced. CNS drug are notoriously hard to get positive clinical trial data for. The reasons are: (1) placebo effect is notoriously difficult to control for in psychiatric trials, (2) the clinical trial endpoints are very blunt measures of efficacy. But you know what? That's the best we have right now. There certainly is a strong requirement for efficacy in psychiatric drugs as evidenced by how many have failed to get approved by the FDA. The sad thing is that most big drug companies have completely pulled out of doing R&D for new CNS drugs. They are just too hard to get approved. The end result is that patients with psychiatric illnesses will end up with fewer treatments options unless this changes.

lutusp 13y ago
> To say that "double-blind prospective trials are nearly non-existent" is very wrong. You need to read each word and think about it. In a prospective trial, subjects are chosen in advance, they aren't drawn from an existing population of people who have already decided to seek psychological help. A "double-blind, prospective trial" would have to sign people up from a cross-section of the population who have no interest in, or association with, psychological treatments. Then they would be divided into two groups. One group would receive the drug under test, the other would receive a placebo. And the trial would have to be designed so that the two groups wold not be able to tell to which group they belonged. Unfortunately, about the drugs under test, most of them have side effects, which means the subjects aren't blinded (the placebo group have no problem realizing who they are). Even will all its defects and shortcomings, what I have just described is unheard of in psychological testing. > Unless you are referring to very old psychiatric drugs, most of them have gone through such trials. Absolutely false. The kind of design I am describing is simply unheard of. Most trials are of self-selected psychological treatment clients, and it's not uncommon for the "control group" to be what are euphemistically called "no-treatment controls". Guess what that means -- it means the experimental group is compared to people who are told to go home with no treatment and no sham treatment. > There was a lot of disagreement about the paper you referenced. Yes, of course -- and that's the way it should be. But there have been enough similar studies and meta-analyses that the outcome is not in question. > But you know what? That's the best we have right now. Different topic. > There certainly is a strong requirement for efficacy in psychiatric drugs as evidenced by how many have failed to get approved by the FDA. Most of the drugs that just were proven ineffective were not ever tested for efficacy as psychological drugs, they were prescribed off-label -- they were originally approved for some other purpose. > The end result is that patients with psychiatric illnesses will end up with fewer treatments options unless this changes. If the treatments were effective, that would be a shame. But they aren't, so it isn't.
- cdjk 13y ago
  Prospective study was probably not the correct term, since that's an epidemiological study. "Placebo controlled study" is probably a better term. And a placebo controlled study is the best evidence for a medical treatment - doing epidemiological studies to determine medication effectiveness doesn't seem right. Consider an SSRI study for depression. I want to know if someone who is depressed and takes it does better thank someone who is depressed and doesn't take it, or takes a different drug. I don't care what it does in a healthy population, since they probably won't be taking it. I mean, the effects of SSRIs in healthy individuals is an interesting topic, but not relevant if I'm investigating depression treatments.
  - lutusp 13y ago
    > And a placebo controlled study is the best evidence for a medical treatment ... Yes, and with respect to the drugs we're talking about, subsequent meta-analyses show that the original studies were all biased in favor of their sponsors and all the drugs produce the same results, which argues for a massive placebo effect. For years, studies were published that appeared to support various drug approaches to mental illness, but those studies have been invalidated by more careful analysis that included (as just one well-known example) unpublished studies that came to conclusions not favorable to the drug companies' outlook. > Consider an SSRI study for depression. Yes, let's do that. As things stand right now, studies of drugs that increase serotonin levels show the same effects as those drugs that decrease serotonin levels. This causes open-minded scientists to doubt the efficacy of this entire approach. Reference: http://www.newyorker.com/online/blogs/elements/2013/09/psychiatry-prozac-ssri-mental-health-theory-discredited.html http://www.newyorker.com/online/blogs/elements/2013/09/psych... Quote: "While S.S.R.I.s surely alter serotonin metabolism, those changes do not explain why the drugs work, nor do they explain why they have proven to be no more effective than placebos in clinical trials." > I mean, the effects of SSRIs in healthy individuals is an interesting topic, but not relevant if I'm investigating depression treatments. Such studies -- with the diagnosed depressed -- show no clinically significant result that can distinguish the outcome from the placebo effect. Those are the facts.
    - 13y ago