3 ms·

> Which is why when determining the safety and efficacy of a drug you should never look at the published studies OK....what do you look at then ?

by zzzeek 14y ago

Alex3917 14y ago
Unfortunately your only options are to file a FOIA request with the FDA or else rely on clinicaltrials.gov. Neither are great options for various reasons. But there have been a bunch of studies that compare all clinical trials with all published trials, and the results are pretty shocking. E.g. the reason why many people mistakenly believe that SSRIs are effective for moderate and severe depression (as opposed to not effective for any type of depression) is because the study that found that made the mistake of relying only on published research. (Which the authors of that study apparently acknowledged later on.) In Irvin Kirsch's book The Emperor's New Drugs he goes over this at length.
- andrewem 14y ago
  FDA FOIA (Freedom of Information Act) Links: Commonly-requested documents: http://www.fda.gov/regulatoryinformation/foi/electronicreadingroom/default.htm http://www.fda.gov/regulatoryinformation/foi/electronicreadi... File a request: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIAR... Structured data about drug reactions ("adverse events") reported to the FDA: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...
- zzzeek 14y ago
  > the reason why many people mistakenly believe that SSRIs are effective for moderate and severe depression (as opposed to not effective for any type of depression) I'm taking an SSRI now, after about ten years off, and have taken them on and off for more than two decades, and they most definitely have a dramatic effect on anxiety and depression - the effects and general mechanism are pretty obvious. Basically, emotional reactivity is reduced as well as the tendency to ruminate. For me, this effect is clear as day, as are why it causes the side effects that it does which is why I typically don't stay on them for very long. While they don't work for everyone, SSRIs have been enormously popular for at least two decades. So I gather that you believe the entirety of SSRI's popularity, as well as all the good/bad physiological effects many of us taking them find so apparent, are strictly placebo effect?
  - Alex3917 14y ago
    "So I gather that you believe the entirety of SSRI's popularity, as well as all the good/bad physiological effects many of us taking them find so apparent, are strictly placebo effect?" When you say "I gather that you believe" you seem to be implying that it's an opinion question. But for what it's worth, that's not how it works exactly. Again read The Emperors New Drugs for a good explanation. The book Anatomy of an Epidemic also has some good info in the relevant chapter.
    - zzzeek 14y ago
      Going on your statement, "not effective for any type of depression", you're saying that the SSRI I'm taking has no effect whatsoever, and that nobody else has any benefits from SSRIs. The good effects we all report are imagined. I'd just like you to directly confirm that's what you're saying. It's a little rude to state that I'm completely misguided in my healthcare choices, then to wave it off as "just go read this book" when i question that.
      - rlucas 14y ago
        It's incorrect to say that grandparent's quote "not effective" is the same as your phrase "no effect whatsoever." The suggestion, following Irving Kirsch's book, that the SSRIs are broadly "not effective," is a statement about the distribution of outcomes over a population. (It also takes into account the fact that even placebos cause changes in outcomes, and that we consider a drug not to be "effective" if its outcomes do not differ meaningfully from those attributable to placebos.) This is maybe better stated as "not efficacious" because we're talking about efficacy, vs. placebo, in a population. This is entirely different from the parent's (counterfactual) statement "the SSRI I'm taking has no effect whatsoever," which is an assertion about having any effect (not a relative effect vs. placebo) in a single individual (not a population). "Not effective"[as a vector operation and vs. a baseline established by placebo] != "has no effect whatsoever"[as a scalar operation and vs. a baseline of no intervention] Grandparent has most definitely not said that your perception of SSRI effects are "imagined," nor that you are "misguided." But you are arguing against a straw man until you at least acknowledge the distinctions here (which, it must be said, are pretty well explained in the book in question ;)

> Which is why when determining the safety and efficacy of a drug you should never look at the published studies OK....what do you look at then ?

by zzzeek 14y ago

> Which is why when determining the safety and efficacy of a drug you should never look at the published studies OK....what do you look at then ?

Alex3917 14y ago

Unfortunately your only options are to file a FOIA request with the FDA or else rely on clinicaltrials.gov. Neither are great options for various reasons. But there have been a bunch of studies that compare all clinical trials with all published trials, and the results are pretty shocking. E.g. the reason why many people mistakenly believe that SSRIs are effective for moderate and severe depression (as opposed to not effective for any type of depression) is because the study that found that made the mistake of relying only on published research. (Which the authors of that study apparently acknowledged later on.) In Irvin Kirsch's book The Emperor's New Drugs he goes over this at length.

andrewem 14y ago
FDA FOIA (Freedom of Information Act) Links: Commonly-requested documents: http://www.fda.gov/regulatoryinformation/foi/electronicreadingroom/default.htm http://www.fda.gov/regulatoryinformation/foi/electronicreadi... File a request: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIAR... Structured data about drug reactions ("adverse events") reported to the FDA: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...
zzzeek 14y ago
> the reason why many people mistakenly believe that SSRIs are effective for moderate and severe depression (as opposed to not effective for any type of depression) I'm taking an SSRI now, after about ten years off, and have taken them on and off for more than two decades, and they most definitely have a dramatic effect on anxiety and depression - the effects and general mechanism are pretty obvious. Basically, emotional reactivity is reduced as well as the tendency to ruminate. For me, this effect is clear as day, as are why it causes the side effects that it does which is why I typically don't stay on them for very long. While they don't work for everyone, SSRIs have been enormously popular for at least two decades. So I gather that you believe the entirety of SSRI's popularity, as well as all the good/bad physiological effects many of us taking them find so apparent, are strictly placebo effect?
- Alex3917 14y ago
  "So I gather that you believe the entirety of SSRI's popularity, as well as all the good/bad physiological effects many of us taking them find so apparent, are strictly placebo effect?" When you say "I gather that you believe" you seem to be implying that it's an opinion question. But for what it's worth, that's not how it works exactly. Again read The Emperors New Drugs for a good explanation. The book Anatomy of an Epidemic also has some good info in the relevant chapter.
  - zzzeek 14y ago
    Going on your statement, "not effective for any type of depression", you're saying that the SSRI I'm taking has no effect whatsoever, and that nobody else has any benefits from SSRIs. The good effects we all report are imagined. I'd just like you to directly confirm that's what you're saying. It's a little rude to state that I'm completely misguided in my healthcare choices, then to wave it off as "just go read this book" when i question that.
    - rlucas 14y ago
      It's incorrect to say that grandparent's quote "not effective" is the same as your phrase "no effect whatsoever." The suggestion, following Irving Kirsch's book, that the SSRIs are broadly "not effective," is a statement about the distribution of outcomes over a population. (It also takes into account the fact that even placebos cause changes in outcomes, and that we consider a drug not to be "effective" if its outcomes do not differ meaningfully from those attributable to placebos.) This is maybe better stated as "not efficacious" because we're talking about efficacy, vs. placebo, in a population. This is entirely different from the parent's (counterfactual) statement "the SSRI I'm taking has no effect whatsoever," which is an assertion about having any effect (not a relative effect vs. placebo) in a single individual (not a population). "Not effective"[as a vector operation and vs. a baseline established by placebo] != "has no effect whatsoever"[as a scalar operation and vs. a baseline of no intervention] Grandparent has most definitely not said that your perception of SSRI effects are "imagined," nor that you are "misguided." But you are arguing against a straw man until you at least acknowledge the distinctions here (which, it must be said, are pretty well explained in the book in question ;)