November 28, 2020

The Niche

Knoepfler lab stem cell blog

Blunt comment from stem cell industry insider in defense of RTT & Texas Law

My recent post on the push for National Right-To-Try (RTT) including a detailed comment from ISSCR stirred some animated feedback.

In the spirit of encouraging diverse discussion, here I am posting a striking comment I received from a stem cell industry insider regarding that post on RTT as it relates to stem cells and s/he was especially focused on the controversial new Texas stem cell law:

“I understand we disagree about these things, but still a little disappointed in how prominent the “snake oil” salesman scare tactic was.  I know it wasn’t you saying these things also, but merely lending your platform.  Still;  the Texas law is very clear that this can only be accessed after IRB approval AND it has to be a hospital or Medical school IRB.  Additionally, the treatment must be administered at that hospital or medical school (state chartered).  So it hardly lends itself to the kind of fraud they are talking about.  This type of IRB approval and institutional only administration is a greater protection than patients get with  FDA APPROVED drugs being prescribed off label.  In addition, the criminal penalty for violating the law is clear and enforceable; if you DON”T have the IRB approval and administer it through the hospital or medical school, you can be prosecuted.  This is a MUCH more effective tool for going after the frauds than exists without it.  I have spoken with DA offices in many states and it’s very difficult to go after these guys.  This type of enforcement mechanism is a good step in helping law enforcement; there is no “grey” area.. you either have the med school or you don’t.  Texas (not my cup of tea in almost anything else they do) should be praised here for making quantitative steps towards getting the fraud in this area under control; not criticized…”

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