6 ms·

So to make sure I have this straight, they'd like to compel a big pharmaceutical company like Pfizer to report all clinical data they've acquired, whether good

by zzzeek 14y ago

So to make sure I have this straight, they'd like to compel a big pharmaceutical company like Pfizer to report all clinical data they've acquired, whether good or bad. Do I have that right? What would be the effect on pharmaceutical companies from such a requirement (and how do you even enforce it)? Would they simply do fewer trials, to avoid the risk of a bad trial result hurting sales of a product?

carbocation 14y ago
It's not like these companies, from a business perspective, generally want to do any more clinical trials than are necessary.
fnordfnordfnord 14y ago
I expect that initial trials would be conducted in some outside venue where reporting was not required. Favorable ones would then be conducted again and reported. Almost the same situation we currently have.
Alex3917 14y ago
"Would they simply do fewer trials, to avoid the risk of a bad trial result hurting sales of a product?" Right now pharma companies run tens of thousands of fake trials where they have no intention of ever publishing the data because it's a way for them to legally pay doctors for signing up patients. Basically they just ask the doctor to fill out a one page survey at the end asking how they felt about how the medication worked, but it's garbage data that couldn't even be used for anything. Basically most phase IV trials, with the exception of the small number the government mandates as a condition for drug approval, are just a scam so that pharma companies can bribe doctors and also so they can list their marketing expenses as R&D in their SEC statements. Also, the vast majority of trials are never published as journal articles even if they're registered. This is because there is no government mandate to actually report the results of any clinical trial, even the registered one. Which is why when determining the safety and efficacy of a drug you should never look at the published studies, because that will always give a wildly inaccurate view in a way that's extremely biased in favor of the drug companies. (This is what the FDA does when deciding wether or not to approve drugs.)
- 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?
refurb 14y ago
Pfizer already publishes all their clinical trials https://www.pfizer.com/research/research_clinical_trials/find_a_trial.jsp https://www.pfizer.com/research/research_clinical_trials/fin... This is just a list of on-going trials, but I believe Pfizer has signed on to publishing their outcomes as well.
chalst 14y ago
Cherry-picked trials are empirically worthless - they are not better than no trials at all. Since drug companies need to submit drug trials to get through approval, it is hard to see how the result of such a rule could worsen the evidence we get.

by zzzeek 14y ago

carbocation 14y ago

It's not like these companies, from a business perspective, generally want to do any more clinical trials than are necessary.

fnordfnordfnord 14y ago

I expect that initial trials would be conducted in some outside venue where reporting was not required. Favorable ones would then be conducted again and reported. Almost the same situation we currently have.

Alex3917 14y ago

"Would they simply do fewer trials, to avoid the risk of a bad trial result hurting sales of a product?" Right now pharma companies run tens of thousands of fake trials where they have no intention of ever publishing the data because it's a way for them to legally pay doctors for signing up patients. Basically they just ask the doctor to fill out a one page survey at the end asking how they felt about how the medication worked, but it's garbage data that couldn't even be used for anything. Basically most phase IV trials, with the exception of the small number the government mandates as a condition for drug approval, are just a scam so that pharma companies can bribe doctors and also so they can list their marketing expenses as R&D in their SEC statements. Also, the vast majority of trials are never published as journal articles even if they're registered. This is because there is no government mandate to actually report the results of any clinical trial, even the registered one. Which is why when determining the safety and efficacy of a drug you should never look at the published studies, because that will always give a wildly inaccurate view in a way that's extremely biased in favor of the drug companies. (This is what the FDA does when deciding wether or not to approve drugs.)

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?

refurb 14y ago

Pfizer already publishes all their clinical trials https://www.pfizer.com/research/research_clinical_trials/find_a_trial.jsp https://www.pfizer.com/research/research_clinical_trials/fin... This is just a list of on-going trials, but I believe Pfizer has signed on to publishing their outcomes as well.

chalst 14y ago

Cherry-picked trials are empirically worthless - they are not better than no trials at all. Since drug companies need to submit drug trials to get through approval, it is hard to see how the result of such a rule could worsen the evidence we get.