Derek Lowe is always the high-quality skeptic on all things pharma, and that’s a valuable role. Still, I feel like this isn’t really engaging with the issues: blogs.sciencemag.org/pipeline/archi…
“Clinical trial regulations are completely unnecessary & don’t improve the quality of research at all” is a strawman. There might be some that are absurd, but in general, these rules are made by smart people, for actual reasons.
Yes, CGMP rules ensure pure & stable drug samples. Yes, rigorous study designs make study results more credible. The question is: how much more credible, relative to the cost?
Part of the problem is, once you have an FDA, it becomes *trusted*. Lots of doctors will immediately go out and prescribe any drug that’s FDA approved. People expect “approved” to mean “I can trust it.”
As long as that’s true, the case for high standards is a lot more sympathetic. Crappy studies are, indeed, crappy, and rarely worth betting a patient’s health on.
But take a different extreme, for perspective. It’s totally legal to write a blog post saying “this drug worked for me!” The fact that this is legal tells you *nothing* about how much credence to put in the post. Free speech doesn’t come with a quality guarantee.
It’s possible that if we allow more crappy studies *and amp up skepticism accordingly* there will be valuable signal amid the noise. Signal that we’re not allowed to generate today.
I actually *agree* with @Dereklowe that most attempts to make medicines that bypass the regulatory system are crap. And I appreciate his work in explaining to the public *why* they’re crap.
The *ethical* position I take (which I know most people don’t agree with) is that you have a right & responsibility to decide for yourself what is crap. And if you want to take risks with your own health, that’s your business.
The *empirical* hypothesis I’m making, which I *do* expect to be a question even skeptics should care about investigating, is that the “optimal” minimum standard for clinical trials is looser than the present standard.
In other words, if there were a proliferation of sloppier trials, would the benefit of getting true positives sooner (& thus faster, cheaper drugs) outweigh the harms of people getting sick from ineffective or dangerous drugs that were reported as good?
I could imagine a world where lower-quality trials were so useless that nobody intelligent believed them. In that case, legalizing them would be morally correct according to me, but a loss from a societal benefit perspective.
Fortunately we have a great natural experiment right now! COVID19 drug & vaccine development is moving at much faster than usual speeds and skipping a lot of typical precautionary steps.
If this “works” for generating drugs or vaccines that actually work, faster or cheaper than average, then we’ll know that there can be value in streamlining these processes.
