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posted by takyon on Saturday July 02 2016, @04:49AM   Printer-friendly
from the right-as-rain dept.

At what point should an experimental drug be made available for anyone to try it?
[...] "Right To Try" law [allows] a therapy to be prescribed after it's passed Phase I and is under active investigation in Phase II. [...] Insurance companies are not required to pay for these, it should be noted, nor are drug companies required to offer access.

The big underlying question here is "Who gets to make the decisions?" Right-to-try advocates would say that the patients themselves should be making those calls (presumably with some advice from their physicians). Others would say no, we need an FDA, some sort of regulatory authority to make sure that the therapies people are choosing from are actually worth choosing. Another argument is that the underlying medical and clinical issues are complex enough to make some sort of expert review worthwhile, and that we can't necessarily expect "informed consent" to always be informed enough under some of the more wide-open proposals.

[...] The Limits of Expertise

Past that, though, you run into the folks who aren't even bothering to appeal to experts at all, because they simply don't trust them much and don't believe what they have to say. Here, too, we have gradations. If we're talking about the Poincaré Conjecture, to pick an issue on one end of the scale, the only people that will be of much use while discussing the details of Grigori Pearlman's proof of it will be those who have devoted serious time to the study of topology. No one who is not comfortable dropping the phrase "Riemannian manifold" into their conversational flow can really have a seat at that table. Even world-renowned prize-winning scientists from many other fields are not going to able to pull up a chair.

Dr. Lowe breaks these types of questions into "Matter for Experts", "Just Plain Facts", "Flat-Out Unknowable", and "Matters of Opinion" and the relative value of expertise for each.

http://blogs.sciencemag.org/pipeline/archives/2016/06/30/expertology

Background on "Right To Try" laws:
http://blogs.sciencemag.org/pipeline/archives/2014/06/10/right_to_try_here_we_go

[Ed. note (martyb): This is the same Dr. Derek Lowe who authored the hilariously-written and highly-informative blogs: Things I Won't Work With and Things I'm Glad I Don't Do.]


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  • (Score: 1) by Francis on Saturday July 02 2016, @05:46PM

    by Francis (5544) on Saturday July 02 2016, @05:46PM (#368925)

    The problem with the FDA is that it just shifts the type of errors between types 1 and 2. And there's little to no attention paid to the effects of drugs over time. It's why Adderall is still legally prescribed even though it's been known to cause Parkinson's disease for decades. The mechanism by which it causes the brain damage is even known.

    It's better that we have the FDA than we just allow people to try any thing they want, we had a system where people could effectively try whatever they wanted and you wound up with even more mountebanks and snake-oil salespeople than we have now and the consequences were even worse.

    Ultimately the FDA regulations are only as good as the doctors and scientists working to get the necessary research done, which is to say it's not terrible reliable, but a huge step up from the unregulated supplements market where the standards are pretty much a matter of dissolving and being what they say it is. No particular guarantee that it works for anybody or that it won't make you blind in the future.

  • (Score: 0) by Anonymous Coward on Saturday July 02 2016, @06:15PM

    by Anonymous Coward on Saturday July 02 2016, @06:15PM (#368933)

    Citation needed for the Adderall statement.

    Drugs get pulled from the market and side effect lists have to be updated.