This is a strategy of the libertarian right that supports Trump. #RightToTry was never about speeding cures to the terminally ill. It was an first step in a long term plan to weaken the @US_FDA and lower the standards for drug approval. 1/
I've been predicting for weeks now that the #COVID19 pandemic would be used as a pretext for the next step in loosening drug approval standards under the guise of "speeding cures to the people" and "loosening red tape." Hydroxychloroquine and chloroquine were the first salvo. 2/
Unsurprisingly, @US_FDA caved and approved these drugs for #COVID19, even though there is a shocking paucity of evidence that they work in humans. One reason is simple: Set a precedent for lowering drug approval standards during a pandemic. 3/ sciencebasedmedicine.org/hydroxychloroq…
In this hydroxychloroquine and chloroquine are perfect as the next shot. They're already @US_FDA-approved for other indications, meaning that they could easily be prescribed off-label for other indications. That meant just getting docs to off-label prescribe builds pressure. 4/
That's exactly what happened. Trump and @FoxNews promoted a handful of "miracle cure" stories plus a really dubious study or two by a French "maverick" scientist and Chinese anecdotal evidence, and, voilà! 5/
Many doctors were revealed to be quite credulous and not very devoted to evidence-based medicine. They started prescribing the drugs willy-nilly. Some of them even started hoarding. Trump then rode to the rescue by persuading drug companies to make more available. 6/
So now, chloroquine and hydroxychloroquine are FDA-approved for #COVID19, which means that states will now have a hard time trying to rein in the mad prescribing going on. 8/
It will also mean that completing proper randomized clinical trials to see if they actually work will become near impossible. No patient will want to risk being randomized to the placebo control group. Why would they? The FDA approved the drugs. That must mean the work, right? 9/
I now fear we will never really know if chloroquine and hydroxychloroquine have clinically meaningful activity vs. #COVID19 because the RCTs will likely never be completed. We'll never know which patients might benefit the most (if they work), what the optimal dose is, etc. 10/
A whole lot of people will be placed at risk for serious cardiac arrhythmia, though. Actually, that's happening now, for no known benefit. 11/
Trump doesn't care, though. His libertarian anti-regulation, anti-FDA backers don't care. They've notched a "victory" against the deep state, the regulatory state. They've set a precedent. 12/
Next step: Get the FDA to super fast track drugs that aren't currently approved and approve them for #COVID19 with inadequate testing. Anyone who's been paying attention knew that this would be their next move, all in the name of "saving patients." 13/
We'll pay a price for this in the future, when drugs are approved based on much lower evidence standards and less rigorous safety testing. Don't worry though. The free market will decide. That's what the anti-regulation right always says. 14/14
