I'm not a treatment expert, but in my experience in AIDS advocacy, the bigger problem is less about therapy-vs-placebo (because, yes, double-blind studies are generally considered a no-no) and more about therapy from company A-vs-second therapy from company A. pharma companies are starting to do some trials to prove their drug is better than someone else's (though of course this requires that they BUY that competitor's drug for the trial, because they're certainly not getting it for free), but almost never will they admit that their own me-too drug isn't much of an improvement.
however, my biggest gripe continues to be the lack of phase IV (post-marketing) trials, which companies agree to in principle in order to get accelerated approval, and yet almost never execute. this would allow the really important factors mentioned here in comments (side effects, dosing differences) to be made a part of a rigorous trial rather than catch as catch can. it would mean using real-world dosing levels (not the maximums that they can sell w/ safety) and real-world drug competition.
thanks for this review, rivka -- i have yet to actually READ angell's book, just a lot of noise around it. (I also find it interesting you didn't mention her former job, as that seemed to be what got her so much of the press when this came out.)
In fact it was patients in HIV trials who made placebo-controlled trials a thing of the past, because they would enroll in the trial, take their drug to a pharmacy and break the blind and if they were on placebo they'd drop out and go enroll in another trial. Health authorities finally twigged to it and realized that placebo in terminal disease was really a horrible thing, so now they allow head to head comparator studies to carry the same weight that they used to mandate thru placebo control.
We do a lot of phase IV post-marketing trials where I am, but maybe in HIV research it's different. I think the patient population and privacy issues are probably vastly different in HIV vs cancer - people don't get socially ostracized for having cancer and for reporting back about their drug experiences.
I'm hoping to get around to reading Angell's book myself, soon!
Great discussion! I think Jerry Avorn's book is better overall, but that's probably an overreaction to Angell's fairly strident tone. It's not as if she doesn't have reasons to be mad.
however, my biggest gripe continues to be the lack of phase IV (post-marketing) trials, which companies agree to in principle in order to get accelerated approval, and yet almost never execute. this would allow the really important factors mentioned here in comments (side effects, dosing differences) to be made a part of a rigorous trial rather than catch as catch can. it would mean using real-world dosing levels (not the maximums that they can sell w/ safety) and real-world drug competition.
thanks for this review, rivka -- i have yet to actually READ angell's book, just a lot of noise around it. (I also find it interesting you didn't mention her former job, as that seemed to be what got her so much of the press when this came out.)
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We do a lot of phase IV post-marketing trials where I am, but maybe in HIV research it's different. I think the patient population and privacy issues are probably vastly different in HIV vs cancer - people don't get socially ostracized for having cancer and for reporting back about their drug experiences.
I'm hoping to get around to reading Angell's book myself, soon!
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