So the criticism got to BrainStorm, did it? Good. Now, a brief thread on #RightToTry.https://twitter.com/DonnaYoungDC/status/1011627015567478785 …
Quack stem cell clinics, for instance, combine a clinical practice with a product that is manufactured by the clinic. It doesn't take much imagination to see how such clinics could see an opportunity for profit by emulating #Burzynski's use of #RightToTry. 7/
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Basically, such clinics could first do a quick phase I trial of whatever their flavor of stem cell quackery is and then get an IND and register phase II trials with the FDA. 8/
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Then, such a quack clinic could rigorously comply with
#RightToTry's provisions for recovering direct costs only but STILL profit from "case management" fees, just like#Burzynski. Don't think they haven't thought of it already. 9/Show this thread -
The bottom line is, I'm glad BrainStem backed down and is trying to be more ethical, even though I really do think their product is not dissimilar to the stem cell treatments sold by dubious stem cell clinics, with little evidence to support its efficacy. 10/
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However, let's not fool ourselves into thinking that there isn't significant profit potential in
#RightToTry. It's just not going to be run-of-the-mill quacks, who don't have drugs that have passed phase I and are in clinical trials, who will do it. 11/Show this thread -
Let's also not forget @SGottliebFDA is not likely to be too enthusiastic about vigorous
@US_FDA enforcement of the direct costs provision of#RightToTry, given the beatdown given him by@SenRonJohnson for having had the temerity to suggest the FDA can still protect patients.12/12Show this thread
End of conversation
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