Unfortunately, it's also been incredibly effective propaganda. Terminally ill patients have been weaponized against critics by #RightToTry advocates in the the same way that cancer quack Stanislaw #Burzynski weaponized terminally ill cancer patients. 1/https://twitter.com/CoyneoftheRealm/status/973529598377058304 …
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Anyone who has anything to do with clinical trials knows that, contrary to the claims of
#RightToTry advocates, merely passing phase I testing doesn't mean a drug is safe. Far from it! Most phase I trials only have less than 30 patients, for one thing. 9/Show this thread -
The purposes of phase I trials are to find the maximal tolerated dose, identify the worst toxicities that limit the dose, and determine if a drug is promising enough (i.e., not too dangerous) to continue to phase II trials to test efficacy and safety. 10/
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The federal
#RightToTry has another pernicious provision. Older versions explicitly stated that@US_FDA could not use clinical outcomes of patients using a drug under RTT in deciding whether to approve a drug. The new version says that it can, but must justify in writing. 11/Show this thread -
Requiring the
@US_FDA to justify in writing using#RightToTry clinical outcomes in its drug approval decisions is somewhat better than the old version, which banned it, but the intent is clearly to DISCOURAGE the FDA from doing so. Only a high ranking official can do it. 12/Show this thread -
Then there's cost. There's no provision in
#RightToTry to help patients access the drugs Insurance companies don't have to pay; there is no fund to assist patients. Basically, they are on their own. Fine if you're rich. Otherwise, not so fine. 13/Show this thread -
To be fair, the federal
#RightToTry bill being considered today does require institutional review board oversight, but, given that it cuts the@US_FDA out of the process, that doesn't really mean much, and there are lax IRBs that can be bought. 14/Show this thread -
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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