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The result is that all state #RightToTry bills contain certain @GoldwaterInst-approved elements, such as any drug that's passed phase I trials, still has an IND, and is still being tested is eligible for RTT. 5/
Of course, claiming phase I testing is enough to show that a drug is "safe" enough for #RightToTry, as I've seen @GoldwaterInst flacks do time and time again, is utterly insane, as anyone who's ever had anything to do with clinical trials knows. 6/
Most phase I trials involve less than 30 patients and involve dose escalation. The idea is not to show safety, but to show that the drug is not too unsafe to continue further clinical trials. There is a difference. Requiring only phase I evidence for #RightToTry is madness. 7/
As for the other @GoldwaterInst-approved elements of #RightToTry, they involve typical libertarian tropes, such as cutting the @US_FDA out of the decision, eliminating liability for companies and doctors, and leaving patients completely on their own if things go south. 8/
Given that less than 15% of drugs that pass phase I ever go on to be @US_FDA-approved, then at least 85% of drugs eligible for #RightToTry will be guaranteed not to provide any benefit, and many of them will cause harm—and the patient might pay a lot of money for the privilege.9/
At the federal level, the new #RightToTry bill makes it difficult for @US_FDA to consider RTT results in considering whether to approve a drug. Major barriers to doing this are intentionally baked into the bill. An earlier version expressly forbade the use of RTT outcomes. 10/
Of course, helping terminally ill patients was never the main intent of #RightToTry, although @GoldwaterInst would like you to think that it was. 11/
The real intent behind #RightToTry was always to cut the @US_FDA out of compassionate/expanded use decisions and to weaken the regulatory power of the FDA. @GoldwaterInst genuinely believes that damned near all regulation is bad. 12/
Indeed, I've seen Nick Gillespie and Ronald Bailey argue that @US_FDA regulations governing drug approval kill thousands of people by delaying promising new drugs. It's a bullshit argument, of course, as I've explained before. 13/https://sciencebasedmedicine.org/using-the-fear-of-ebola-to-promote-the-placebo-legislation-that-is-right-to-try/ …
#RightToTry is just the first step in @GoldwaterInst's plan to neuter the @US_FDA. Next up will be broadening RTT so it doesn't apply just to terminally ill patients. After that will be eliminating restrictions on companies advertising off-label indications for their drugs. 14/
The @GoldwaterInst's long game after #RightToTry is to return the @US_FDA to its pre-thalidomide state, where evidence of efficacy is no longer required to approve drugs. 15/15
Long-term results.
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