So the criticism got to BrainStorm, did it? Good. Now, a brief thread on #RightToTry.https://twitter.com/DonnaYoungDC/status/1011627015567478785 …
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I'm not a lawyer, but still I see no way in the current
#RightToTry law to prevent a business model like that of#Burzynski. Burzynski, if you'll recall, didn't charge for his drug itself (antineoplastons, ANPs), but did charge enormous "management fees" for administering it. 4/.Show this thread -
Remember,
#Burzynski's ANPs had passed phase I testing, and he kept dozens of phase 2 trials open to let him treat whatever cancer he wanted with them. His whole business model was basically legalized by this federal#RightToTry law. 5/Show this thread -
So, while some skeptics are incorrect to state that
#RightToTry will allow any quack to administer ineffective unapproved medicine to patients—after all, how many quacks have drugs that passed phase I?—it is also not correct to dismiss the likelihood that companies can profit. 6/Show this thread -
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/Show this thread -
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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