3 ms·
I post a fair number of stories about regulation of medical treatments here on Hacker News. I see this one has attracted a lot of reader interest. The comments
by tokenadult 12y ago
I post a fair number of stories about regulation of medical treatments here on Hacker News. I see this one has attracted a lot of reader interest. The comments already posted as I post this comment point out that once someone sets up a regulatory program, the incentives become powerful to figure out ways to cheat the regulators. And, as usual, scientific research is hard (another topic I post a lot about here), and researchers all operate under incentives to publish interesting and hopeful results rather than acknowledge that their research program didn't show what the researchers hoped to show.
The submitted article identifies a specific problem in how the FDA doesn't publish identifying details of studies that its own inspectors discovered to have problems. Biomedical researchers, then, don't know which previous study findings are flawed, even though the FDA detected flaws, and much time and effort is wasted trying to pursue research results that don't reflect reality. That has to change.
Meanwhile, there is a different pattern of regulation for some products that consumers in the United States take regularly as they seek better health, namely "natural supplements." For natural supplements, the regulatory problem is far worse, because those products can go on the market with no research done on safety or effectiveness at all, and without even any guarantee that the product contains the labeled active ingredient,[1] a plain violation of the warranty of merchantability in the Uniform Commercial Code.
So the better trade-off for the consumer here is to amend existing law so that as drugs go through clinical trials, disclosure and peer review of FDA inspection findings during the trials is a condition for marketing approval. If manufacturers can't deal with that kind of regulation, tough. But it's only fair that natural supplement products, a multi-billion-dollar industry, should be regulated the same way.
(To answer a question asked in another comment, already well answered overnight in my time zone, yes, "science-based medicine" includes "evidence-based medicine," that is clinical trials, as a subset of practices that include also consideration of fundamental principles of science and statistical understanding of prior plausibility before interpreting clinical trial results. If a sample size is small enough, many implausible treatments can look like successes in a clinical trial, especially for subjective, patient-self-reported symptoms, but we shouldn't call such treatments effective until they have been replicated in larger samples and verified with independently gathered "hard endpoint" data about clinical signs.)
[1] "Searching for the supplement in your supplement"
http://www.sciencebasedmedicine.org/searching-for-the-supplement-in-your-supplement/ http://www.sciencebasedmedicine.org/searching-for-the-supple...
- Alex3917 12y ago> For natural supplements, the regulatory problem is far worse [...] So the better trade-off for the consumer here is to amend existing law so that as drugs go through clinical trials, disclosure and peer review of FDA inspection findings during the trials is a condition for marketing approval. - The FDA already has the power to regulate supplements, for the most part they just choose not to. So the idea that supplements just need FDA regulation like 'regular drugs' is largely fallacious. - Why should supplements need clinical trials for marketing approval when that isn't the standard for other any other comparable drugs on the market? I.e. almost all drugs that were in use before the 50s are allowed to be marketed without any testing for safety or efficacy, and since almost all supplements have a much longer history of human use, why should they be treated differently?
- tokenadult 12y agoThe FDA already has the power to regulate supplements, for the most part they just choose not to. No, the "natural supplements" industry has carved out for itself a huge exemption from most of the regulation that applies to drugs, on the one hand, or foodstuffs, on the other hand. See a group blog post on "Big Supp"[1] for more information about this. For years, that industry had a champion in Congress[2] who resisted more effective and rational regulation. [1] http://www.sciencebasedmedicine.org/big-supp-resists-giving-consumers-safety-and-effectiveness-information/ http://www.sciencebasedmedicine.org/big-supp-resists-giving-... [2] http://www.sciencebasedmedicine.org/fda-versus-big-supp-rep-burton-to-the-rescue-again/ http://www.sciencebasedmedicine.org/fda-versus-big-supp-rep-...
- Alex3917 12y ago> No, the "natural supplements" industry has carved out for itself a huge exemption from most of the regulation that applies to drugs, on the one hand The FDA's own website contradicts you here: http://www.fda.gov/Food/DietarySupplements/ http://www.fda.gov/Food/DietarySupplements/ The FDA, on their own website, says it's their job to make sure that supplements are unadulterated and not mislabeled. If 80% of supplements are in fact completely fake, then I don't see how you're using the problems of the supplement industry to show how well the drug industry is regulated in comparison.