2/ This study should have been overseen by the @US_FDA, but by all appearances Rational Vaccines flouted the rules and went forward without oversight.
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3/ Why? Because its founders & scientists didn't accept the important role of the FDA in therapeutic development and validation--they saw it instead as a ponderous bureaucratic obstacle to validating treatments and getting them to patients.
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4/ The same perspective informs
#RightToTry; it views the@US_FDA as a bureaucratic obstacle that stands between patients and the drugs that might cure them.Show this thread -
5/ The common thread is efforts, from a "libertarian" perspective, to delegitimize the
@US_FDA. (I put libertarian in quotes because I'm skeptical that the main motivation is deeply held philosophical belief)Show this thread -
6/ I'm profoundly relieved that
#RightToTry failed tonight, because if these efforts to delegitimize the@US_FDA take hold, we will see many more cases of unscrupulous actors offering "treatments" and "trials" that are really about making a buck.Show this thread -
7/ That's why efforts to defend the
@US_FDA are so important if you care about patients and the public health. /endShow this thread -
postscript/ There are legitimate arguments about how the
@US_FDA should balance access vs. rigorous evaluation. https://jamanetwork.com/journals/jama/article-abstract/900544 …Show this thread -
PS2/ I happen to have a conservative view, but respect the arguments of those who believe otherwise. It's the fundamental rejection of the concept that drugs should be shown to have efficacy that justifies their risks that most troubles me.
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