Colorado passed a new law supported by the ultra-conservative Goldwater Institute, the so-called Right To Try Law. This law allows patients to try experimental, unapproved medical interventions that have completed a Phase 1 clinical trial. Most Phase 1 drugs ultimately fail to be proven safe and effective and Phase 1 only demonstrates a minimum baseline level of safety.
Interestingly, Colorado is also a hot bed for experimental stem cell-related interventions. Putting these two realities together, when the Right-To-Try Law passed it seemed likely that we’d be seeing Colorado ending up as a magnet for patients wanting to try experimental, non-FDA approved stem cell therapies and that stem cell companies, including some that previously had records of compliance, would eventually begin federally non-compliant or at least unapproved operations in Colorado.
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.
Read the full, original story: Neuralstem flirting with stem cell noncompliance in Colorado via Right To Try Law?