I frequently check in to see what’s happening at the Paul Knoepfler Stem Cell blog. His post yesterday took me by complete surprise. Even though SCI isn’t part of the PTT Law, this will be an interesting situation to follow. (The mission of the Knoepfler Lab Blog at UC Davis School of Medicine is to build stem cell bridges to cures through education, outreach, and science).
“It didn’t take long for these predictions to be realized as stem cell biotech Neuralstem announced on June 5 that it would be offering its experimental, non-FDA approved human neural stem cell therapy for ALS in Colorado. And it might do it in a for-profit manner. Further, Neuralstem CEO Richard Garr has indicated that the company will not work with the FDA for the human experiments in Colorado. It is worth pointing out that CEO Garr is also Chair of the Goldwater Institute’s Right To Try National Advisory Council.
In a sense, the Colorado Right-To-Try Law as it pertains to stem cells is itself a big human experiment and it will be probably end up being fascinating and perhaps disturbing to see how this all plays out even as there are concerns over risks it brings with it. I worry it might do more harm than good. What do you think?”
Check out Paul’s full blog post HERE:
THE FDA IS NOT THE ENEMY: THE CHAIRMANS BLOG with RICHARD GARR Check Richard Garr’s position on the PTT Law.
No one is suggesting that this process take the place of the existing clinical trial process. And no company (though I can only speak for Neuralstem) will offer a drug if the FDA tells it not to. The heart of the RTT bill recognizes the contribution the FDA process makes to the determination of safety in the early stages of drug development and Neuralstem’s support of this program is based upon that recognition.
No one is promising cures. Every patient that Neuralstem can treat under this law until we have FDA approval will go through the exact same informed consent process that patients in our trials go through. They will understand the risks. No matter how encouraging the early public information may be, all of our patients understand that it is too soon and there have been too few patients for us to know that it can help them. Dying patients deserve the unvarnished truth, and, in our experience, they demand it.