The journal Nature published an excellent editorial earlier this week on stem cell oversight and stem cell clinics.
The piece, entitled ” FDA should stand firm on stem-cell treatments. US regulators must regain the upper hand in the approval system” struck just the right balance. It correctly supported the FDA’s data-centered approach to stem cell oversight and indicated that this regulatory system is not too harsh. At the same time, the editorial also rightly asserted that the FDA cannot simply stick entirely to the status quo and needs to be more efficient.
The editorial also hit the nail on the head by discussing stem cell oversight, the REGROW Act, and stem cell clinics all within one interconnected arena. That’s the reality of the stem cell world today. Too many FDA critics and supporters of a weakened oversight system essentially pretend the stem cell clinics are not going to be affected by efforts that would limit FDA oversight of stem cells.
It was great to see that the Nature editorial cited the new paper by Leigh Turner and I on the astonishingly large number of stem cell clinics in the US. Given the scope of the stem cell clinic industry in the U.S. (at least 570 clinics) and the remarkable range of conditions marketed to be treated using a variety of stem cell types, there are at the very least serious questions about compliance at some clinics because of issues related to more than minimal manipulation and non-homologous use. See Figure 2 from our paper above.
The system of reduced oversight of stem cells and regenerative medicine in Japan that the FDA critics so often point to is in reality a still on-going, risky regulatory experiment and the jury is out on whether the risks there are going to be worth it or will rather end up injuring patients and damaging the reputation of the stem cell field.
The Nature editorial concludes with a look to the future and ideas on how to proceed:
“The FDA should strive to keep this debate on the proper topic — how to create a more efficient system that still scientifically evaluates whether treatments are safe and efficacious. To fall short would be a setback for science, and for patients.”
In addition, I believe the FDA needs to be clearer and more consistent both between its statements and its actions. Many scientific and medical experts in the field, even those who disagree on the appropriate level of oversight, agree that there is a problem with the FDA being too inconsistent and unclear. The FDA also must be more proactive on the stem cell clinic problem. So far the FDA has been far too nebulous on stem cells as well as very slow and passive with a growing clinic industry that the agency itself has given every indication instead needs proactive and concrete oversight.
I hope that our paper serves as a wake up call to the stem cell field and the regulators that there’s a big problem here in the U.S. that is just going to keep getting bigger, especially if decisive, consistent action isn’t taken. Further, those proponents of a weaker FDA oversight system now more than ever need to get real by discussing both the potential benefits and risks of what they want, placing it all in the context of academic, biotech, and clinic activities.