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.
Background on "Right To Try" laws:
As the world knows, we face an emerging virus threat in the Wuhan coronavirus (2019-nCoV) outbreak. The problem is, right now there are several important things that we don't know about the situation. The mortality rate, the ease of human-human transmission, the rate of mutation of the virus (and how many strains we might be dealing with – all of these need more clarity. Unfortunately, we've already gone past the MERS outbreak in severity (which until now was the most recent new coronavirus to make the jump into humans). If we're fortunate, though, we'll still have something that will be worrisome, but not as bad as (say) the usual flu numbers (many people don't realize that influenza kills tens of thousands of people in the US each year). The worst case, though, is something like 1918, and we really, really don't need that.
[Ed note: The linked story is by Derek Lowe who writes a "commentary on drug discovery and the pharma industry". He is perhaps best known for his "Things I Won't Work With" blog entries which are as hilarious as they are... eye opening. I have found him to be a no-nonsense writer who "tells things as they are", holding no punches. The whole story is worth reading as he clearly explains what a coronavirus is, about the current one that reportedly originated in Wuhan, China, what could be done about it, how long that would likely take, and what can be done for those who have already been infected. --martyb]
Previous Stories Referencing Derek Lowe:
Machine Learning Comes to Biochemistry
Ignition! The Funniest, Most Accessible Book on Rocket Science is Being Reissued
Another Failed Alzheimer's Disease Therapy
Marathon Pharmaceuticals is Part of the Problem
Lobbying Results in FDA Approval for Controversial Drug
"Right to Try" New Experimental Medicine and the Value of Experts
Cancer Hazard vs. Risk - Glyphosate
A Terrific Paper on the Problems of Drug Discovery
Things I Won't Work With