What's the problem with Big-Pharma getting involved with stem cell therapy?


Would you pay $500,000 for a one-time stem cell treatment? You would if it was your little girl that had cancer, and Big-Pharma knows it.

Yes, if your child were to get leukemia there is a stem cell treatment named Kymriah by Novartis Pharmaceuticals that will charge you $500,000 dollars for a one time treatment. Yes, a half million dollars! it appears to be about 85% effective but that's a little steep for anyone’s budget. Within the next year those costs are expected to come down to about $300,000 for a single dose. What a bargain!

My concern with Stem Cell Therapy and Big-Pharma? The FDA will likely continue to provide pathways for approval primarily favoring pharmaceutical companies with deep pockets and FDA privileges that exceed smaller companies such as ours. In this way the FDA will continue to call YOUR stem cells a drug and therefore require pathways exactly the same as drug manufacturing - costing companies between 1.5 - 2.0 billion dollars to get approval (the average costs from inception to drug approval in the U.S. is $2,000,000,000.00 - not a misprint!), and when that’s the requirement you get stem cell therapies that cost a half-million dollars.

The FDA needs only to provide strict guidelines to be followed by physicians, such as sterile technique and proof of good manufacturing practices (GMP). Then let the market determine stem cell price points. Otherwise, leaving the country will continue to be a normal thing for medical treatments.