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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: 2) by DutchUncle on Tuesday July 05 2016, @01:57PM

    by DutchUncle (5370) on Tuesday July 05 2016, @01:57PM (#370065)

    John W. Campbell wrote an editorial in Analog SF/SF many years ago suggesting a category of "Registered Quack". The idea was that instead of the FDA blanket prohibiting things, a patient with a serious disease could do whatever they wanted as long as (1) they signed up to take responsibility for themselves and not blame anyone else if it went wrong, and (2) they signed up for meticulous record-keeping and occasional testing by normal medical practice, just on the off-chance that they actually hit upon something worthwhile. This editorial was derided as fostering anti-science attitudes, but - especially considering Campbell's other writings - I read it as suggesting that people should be allowed to take chances and try extreme and/or experimental treatments when normal medicine has already told them they have little to lose.

    "Tough Medicine" (article in New Yorker) discusses how some cancer cases have been cured by using medicines at higher doses or for different uses than officially approved, and how study results that should influence standard practice are instead discounted and ignored.

    There should never be experiments on people without their full knowledge; but if someone with a serious (and especially terminal) disease is willing to be the next guinea pig in the hope that it works for them, why not let them?

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