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And when we're discussing medical care, the mandatory regulatory approvals are a significant cause of delay and cost. E.g. FDA approvals in the U.S. They are a
by ptaipale 10y ago
And when we're discussing medical care, the mandatory regulatory approvals are a significant cause of delay and cost. E.g. FDA approvals in the U.S.
They are a barrier to entry, and they are a measure to ensure safety of new cures. It's a tough balance.
- chiph 10y agoBased on the history of drugs like Thalidomide, I'll pick safety. https://en.wikipedia.org/wiki/Thalidomide#History https://en.wikipedia.org/wiki/Thalidomide#History
- ptaipale 10y agoSafety is good, but it's not a dichotomy of "absolutely no safety" or "safety trumps all other things". It seems to me that the safety aspect is currently very strong, on the expense of long time-to-market and high barrier of entry to market.
- splawn 10y ago.....but we are talking about healthcare. Safety should trump all other things. https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere
- ptaipale 10y agoIf safety absolutely trumps all other things, then there can be no trials of anything (because by definition, a trial is there to experiment and find out about possible safety issues) and there would be no development of new medicines at all. That would not mean staying where we are, it would mean starting to slowly go backwards in the tools available for health care (because e.g. some antibiotics are slowly becoming inefficient and new ones should be developed - and currently the world is not doing enough of that.) See e.g. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095020/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095020/
- splawn 10y agothat is disingenuous... as you said "a trial is there to experiment and find out about possible safety issues". You have to test drugs before you can feed them to everyone safely.... but you obviously already knew that and just wanted to be contrarian.
- zzzzz99997 10y ago..no. Treating sick people and improving the health of our species should trump all other things.
- splawn 10y agoI will just cross my fingers that you eat a bunch of untested drugs then... for your health! :D
- tommorris 10y agoThe flipside of that is the response to the AIDS crisis. If it hadn't been for activists from groups like ACT-UP and Queer Nation screaming, shouting and making a big stink about the need for a response from the FDA, the federal government more generally, and the pharmaceutical industry, there'd be a whole lot of people who wouldn't be alive today. http://healthland.time.com/2012/09/27/how-to-survive-a-plague-qa-with-act-ups-peter-staley-on-effective-activism/ http://healthland.time.com/2012/09/27/how-to-survive-a-plagu... https://www.opendemocracy.net/transformation/ray-filar/silence-death-sarah-schulman-on-act-up-forgotten-resistance-to-aids-crisis https://www.opendemocracy.net/transformation/ray-filar/silen...