3 ms·
> We need to end off label use. Saying a drug is approved for one diagnosis and then allowing it for any other diagnosis is, in the modern age, simply crazy. On
by awalton 7y ago
> We need to end off label use. Saying a drug is approved for one diagnosis and then allowing it for any other diagnosis is, in the modern age, simply crazy. One might as well not have fda approval.
This is patently ridiculous. The FDA just proved the drug was safe in therapeutic doses and that it treated what it said it treated. They didn't say that the drug wasn't safe to treat other things, and they didn't say the drug was generally unsafe. If doctors are prescribing non-therapeutic doses, yeah, that might be a problem, but there are entire clades of diseases that would otherwise be untreatable without off-label use. (And the frank alternative - labeling all of the drugs as being usable for all of the various conditions - can't keep up with reality. The FDA is slow and meticulous, and if we forced that on off-label used drugs, there'd be a lot more suffering for literally no good reason. And it probably wouldn't do anything for actually stopping off-label usage - doctors would just start lying and overclassifying their patients as having diseases to give them the meds. E.g. there'd be a whole lot of autoimmune patients with various "overlap syndromes" that suddenly have lupus and/or rheumatoid arthritis, despite not meeting the current diagnostic criteria, just so they could keep taking adalimumab, methotrexate and/or hydroxychloroquine. It's just red tape they don't need nor care about.)
We've done actual wonders in the world by simply scanning through approved drug combinations to find treatments for ailments. An example of this is in cancer treatment: it's fairly common one cancer drug will treat multiple classes of cancer, especially in combinations with other drugs (even ones not designed to fight cancer specifically). It's so commonly the case that this is now its own entire enterprise: high throughput scanning of drug combinations to fight tumors. https://www.biorxiv.org/content/10.1101/051698v1.full https://www.biorxiv.org/content/10.1101/051698v1.full It's also been done to treat viruses and autoimmune diseases.
I'm not a super libertarian or anything, but I believe if a doctor has a reasonable belief that a drug will treat a condition, and therapeutic trial evidence bears it out, there's not a good reason not to prescribe it, whether or not it says on the bottle that that's okay. I've benefited from this in the past and I will continue to in the future.