Re:FDA blindsided as Trump Admin cripples agency on its way out
by maxharris on Friday January 15, 2021 @04:59PM
(#25797104)
Putting a 10-year time limit on regulations is actually a very good idea. We have an incredible number of regulations from the 1930s still on the books, 90 years later. These regulations come at a great cost. For example, Moderna's mRNA vaccine technology languished on the shelves, unused, for ten years before our present crisis forced its hasty validation. As the New York Times reported recently, mRNA-1273 was developed in just two days in January 2020. According to the Worldometer tracker, we just crossed over four hundred thousand COVID-19 deaths in the US (January 15th, 2020). Had fewer regulations impeded its development and testing, a great number of these lives might have been saved.
Before you reflexively downvote me, please note that I'm not a Trump supporter or even a conservative.
Re:FDA blindsided as Trump Admin cripples agency on its way out
by fat_pikachu on Friday January 15, 2021 @05:09PM
(#25797206)
Take a look at some of the rules surrounding emergency approval of the early COVID-19 tests. They weren’t even 20 years old and we’re already outdated.
As I recall, one group was denied approval because they were required to ship a hard drive with their data.
Re:FDA blindsided as Trump Admin cripples agency on its way out
by bsder on Friday January 15, 2021 @05:42PM
(#25797526)
> For example, Moderna's mRNA vaccine technology languished on the shelves, unused, for ten years before our present crisis forced its hasty validation.
It languished because human trials are expensive and vaccines against rare diseases don't make any money.
And the rules around human trials are there for a reason. Tuskegee wasn't that long ago. The Stanford Prison Experiment was useless and caused much harm.
Once we had Covid, suddenly there was LOTS of money to run those human trials in the proscribed manner. And there were lots of volunteers to do so without human coercion.
Obviously, some amount of testing is necessary to bring a new drug to market (and the examples you point out support this). If there is no alternative but suffering and death for a condition, having these blanket regulations in place that block new drugs and new treatments only contributes to suffering.
Before you reflexively downvote me, please note that I'm not a Trump supporter or even a conservative.
As I recall, one group was denied approval because they were required to ship a hard drive with their data.
It languished because human trials are expensive and vaccines against rare diseases don't make any money.
And the rules around human trials are there for a reason. Tuskegee wasn't that long ago. The Stanford Prison Experiment was useless and caused much harm.
Once we had Covid, suddenly there was LOTS of money to run those human trials in the proscribed manner. And there were lots of volunteers to do so without human coercion.
Correct. This is because regulations raise the barrier to entry for new drugs to $2.6 billion (in 2019 dollars) https://www.policymed.com/2014/12/a-tough-road-cost-to-devel...
Obviously, some amount of testing is necessary to bring a new drug to market (and the examples you point out support this). If there is no alternative but suffering and death for a condition, having these blanket regulations in place that block new drugs and new treatments only contributes to suffering.
If you get rid of regulation you don't get vaccines faster you get vaccines that kill you because they are dangerous.