Normally a national news story on the problem of the mushrooming stem cell clinics selling unapproved “treatments” would be a positive development, but this otherwise very nicely done story might have a major error that could confuse millions of viewers.
The NBC story by Anna Schecter and Stacey Naggiar is entitled “Costly, Unproven Stem Cell Therapy for Neurological Disorders Questioned”. It focused on Cell Surgical Network, a franchising chain of stem cell clinics selling non-FDA approved, fat-based stem cell interventions for a host of conditions. For background see my interview with the leaders of Cell Surgical Network and another post on my concerns about their operations.
Overall this was a very well-done, balanced NBC report, but a key part of this story was a bombshell claim by NBC that the FDA does not regulate these stem cell “treatments”. This seems frankly very difficult to believe.
So in an otherwise fine report, did NBC make a major mistake on the FDA or did the FDA make a major tidal policy change to weaken its own regulation of stem cells without telling anyone else? That latter possibility sure doesn’t sound like something that the FDA would do.
I have emailed Schecter to ask for clarification and a potential correction of this part of their story if appropriate. Schecter had talked quite a bit with me when preparing the story. I indicated that the adipose stem cell preparations of Cell Surgical Network were from my perspective almost certainly to be viewed by the FDA as more than minimally manipulated. I also stressed that the FDA does indeed by all accounts regulate these therapies and every bit of recent FDA guidance would suggest no recent change.
For example, the FDA just issued new guidance in the last few weeks that is consistent with their continued regulation of these stem cell treatments. I also just this week posted my interview with the FDA in which they indicated in their own words no apparent change in policy. So it sure would seem the FDA is in fact regulating these stem cell “treatments” even if they are going about it more slowly than many of us would wish.
Still, at the end of the NBC stem cell story video, NBC News Chief Medical Correspondent Dr. Nancy Snyderman unambiguously says that the FDA told NBC News that it does not regulate these stem cell “treatments”. You can see an image above from NBC of Snyderman interviewing Dr. Steven Gitt, a physician member of the Cell Surgical Network with a clinic in Phoenix.
Also in the written NBC story, it says:
“Under FDA guidelines, the procedure used by Berman and Gitt is not regulated because the cells are “minimally manipulated,” aren’t combined with other genetic material and the patient gets only his or her cells re-injected.”
So did the FDA just do a complete U-turn on regulation of stem cells or did NBC err in this key part of their story?