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It’s hard enough to run a clinical trial guys. It literally costs $100 million at a minimum, yet the requirements that make it cost this much are not enough. We
by mjfl 3y ago
It’s hard enough to run a clinical trial guys. It literally costs $100 million at a minimum, yet the requirements that make it cost this much are not enough. We are basically going to regulate new medicine out of existence.
- WastingMyTime89 3y agoPlease read the article before commenting. The problem is not how hard it is to run clinical trial. It's that made up data is an endemic problem. It doesn't matter if clinical trials are hard or easy to organise when up to a quarter don't actually bother and just forge their results.
- chaxor 3y agoBut they have to make up that data! Because the work they are doing now was based on a other trial where they made up data, so you have to fix this data to match what was expected from the previous studies. Of course we need to protect their right to make up data. /s
- droopyEyelids 3y agoHamilton Morris recently did a podcast that touched on some of this, I think it was https://www.patreon.com/posts/pod-78-legal-84786504 https://www.patreon.com/posts/pod-78-legal-84786504 An interesting point he made was that in the wake of the Thalidomide (https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide) scandal, the FDA started requiring drugs to be both safe _and effective_ https://www.fda.gov/about-fda/histories-product-regulation/promoting-safe-effective-drugs-100-years https://www.fda.gov/about-fda/histories-product-regulation/p... The 'effective' part has proven to be a big source of complexity in the following years, because while it's relatively easy to prove a drug is relatively safe, it's much more difficult and subjective to prove a drug is effective. That closes off a lot of areas of research and development. The kicker is that Thalidomide was never sold in the USA to begin with. Anyway, as any reader can imagine, there would be a lot of negative social outcomes to allowing the sale of ineffective drugs. There's a lot of trouble now with medical devices and drugs not being effective, even though we have the rule. I'm not against regulation, I think medical sales are a really complex issue and I don't know how to even judge where the right balance of safety/effectiveness and innovation/freedom could be.
- throw9away6 3y agoThey kind of broke that when they allowed the approval of Aduhelm which is basically shown to be expensive and ineffective
- dekhn 3y agoThalidomide is sold in the USA as a treatment for several conditions- it's a highly effective drug and is mostly safe within the target population. (I point this out because most people only tell the very first part of the thalidomide story).
- sonicshadow 3y agoYeah who needs truth and accuracy anyway? Think of the small businesses who will never be because they couldn’t get a simple drug on market with minimal testing
- mjfl 3y agoYou have to put $100 million into effective testing. Your comment is disingenuous.
- sonicshadow 3y agoThat’s a word
- lost_tourist 3y agoYou should read the article, they aren't asking for more regulation, just more skepticism out of publishers and that scientists keep their raw data available for inspection by peers.