Never mind that you're pointing out that #RightToTry is incredibly unlikely to help any patients, hasn't demonstrably significantly helped anyone thus far, and is anti-patient in that it strips away many protections patients have. 4/
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To be fair, the federal
#RightToTry bill also requires that doctors and investigators report adverse events to the company, which then must report them to the@US_FDA. However, I am skeptical how well that would work outside the context of clinical trials. 15/Show this thread -
So, to summarize,
#RightToTry: 1. Is incredibly unlikely to help patients 2. Strips away important legal protections from patients 3. Strips away important regulatory protections from patients 4. Is unlikely to significantly expand access to experimental therapeutics 16/Show this thread -
So if
#RightToTry is so useless, why do it? There's no good medical or policy reason to pass RTT, except for one: As a first step in deregulation, as a first step in weakening the FDA. 17/Show this thread -
Given the source of
#RightToTry (@GoldwaterInst), and the fact that the Koch brothers recently threw their support behind RTT through@AFPhq, it is reasonable to conclude that the purpose is to weaken@US_FDA. 18/https://twitter.com/AFPhq/status/973320042292174851 …Show this thread -
Indeed, I've long suspected that the true reason for
#RightToTry is to be a first step in drastically curtailing the power of the@US_FDA to approve and regulate drugs and devices. 19/Show this thread -
Think about it. First, you cut
@US_FDA out of regulating drugs for an incredibly sympathetic group of patients, the terminally ill, in the name of helping them. 20/Show this thread -
Once the precedent is set, you ask the question: Why limit
#RightToTry to just the terminally ill? What about those who have life-threatening illnesses who have a significant chance of dying? They already did this with Ebola. https://respectfulinsolence.com/2014/10/28/ebola-right-to-try-laws-and-placebo-legislation/ … 21/Show this thread -
Then, they'll ask, what about patients with severe, not immediately life-threatening diseases that dramatically impact quality of life? Why no
#RightToTry for them? 22/Show this thread -
Finally, they'll ask: Why not everyone? In fact, others have already in essence done that through something called Free To Choose Medicine. 23/https://respectfulinsolence.com/2017/08/30/right-to-try-medicine-the-free-market-fundamentalist-assault-on-the-fda-continues/ …
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Indeed,
@GoldwaterInst has already broadened its assault on the@US_FDA's power to regulate drugs beyond#RightToTry with its initiative to prevent the FDA from stopping companies from promoting off-label uses of their drugs to doctors. 24/Show this thread -
So,
#RightToTry is not about helping terminally ill patients. It's about returning@US_FDA to a vestigial pre-Kefauver-Harris Amendment status, in which the FDA only had to require that companies show safety, not efficacy, before licensing a drug or device. 25/Show this thread -
Unfortunately,
#RightToTry has been an incredibly effective propaganda technique. 38 states have passed RTT, largely because opponents have been successfully cowed into silence by their desire not to be tarred as hating on terminally ill patients. 26/Show this thread -
While it's true that
@ASCO has finally woken up, it's too little too late. Medical societies have been shamefully silent until now. The time to oppose#RightToTry was four years ago, before it became a juggernaut that will now likely pass. https://respectfulinsolence.com/2018/03/12/cruel-sham-right-to-try-will-be-up-for-a-vote-house-tuesday/ … 27/27Show this thread
End of conversation
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