NBC News did a big on-line story and even a NBC Nightly News Segment on dubious stem cell therapies on Friday.
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?
From the point of view of an outsider, it always seemed to me that the FDA pretty much regulates whatever it wants to regulate. That may change:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/11/how-far-does-fdas-say-so-travel.html
I suggest that the real issues in the present instance are:
(1) The nature of the treatment and the nature of the disease. If you really want to carry the argument then make the scientific/medical argument. Patients are not immune from sound reasoning that is founded upon solid knowledge.
(2) The credentials of the plastic surgeons (their publications) relative to the diseases being treated and their demonstrated knowledge of the biology of stem cells and relevant laboratory procedures.
I’m irked that NBC treated the matter in such a superficial way — which was the usual strawman wrestling match: “pioneering doctors vs authority and convention”. And I’m disappointed that people who have serious expertise (I do not) simply follow the lead of NBC!
Dr. Virgil DiBiase asked the question: “What’s a plastic surgeon doing treating a neurological disease?” Now that’s the begining of a question that is worth serious examination but it was left hanging! Even more to the point is the question that was neither asked nor addressed: “What is the scientific basis for the plastic surgeons treatment vs that/those being investigated by “legitimate” researcher(s)?”
Come on you experts, get off the FDA-must-rule-all hobby-horse and make the argument why you’re right and they’re full of bull!
It’s amazing how often media gets things just plain wrong. I can be a bit more forgiving of daily newspapers, which are working on tight deadlines. But feature stories percolate for months within a news department before they are released to the general public, so there is plenty of time for due diligence and vetting.
WTF???
This is migraine-inducing. Not just whether the stem cell clinics are regulated, but whether we can trust clinicaltrials.gov at all. I have often recommended the site to patients seeking experimental therapies. Is there a more trustworthy resource?
Hey Brad. Thanks for the comment. We are at a point where the quality of information in the public domain regarding investigational stem cell products and procedures and pre-clinical findings is coming more into question including company statements, publications, federal databases, and more.
Looks to me like NBC drank the CSN koolaide on that one. No doubt many lawyers involved. With its recent guidance FDA is stripping away CSN’s last big line of defense which was the ‘same surgical procedure’ exception. Lack of enforcement does not equal lack of regulation or lack or jurisdiction. There’s a showdown coming and its not a matter of ‘if’ but ‘when’.
Thanks for the comment, Lee. It’s very frustrating how this went down in terms of the report.
It does seem like something’s gotta give at some point in this potential regulatory situation.
What NBC really should do is report about the one legitimate scientifically proven HSCT Hematopoietic Stem Cell Transplant being done for years for MS, CIDP, RA, MG, Lupus, Scleroderma & many other auto immune disease at Northwestern University in Chicago by Dr. Richard K. Burt. It’s an FDA approved clinical trial & STOPS the disease from progressing. My husband had HSCT for MS in 2011. It stopped his MS & he had had no progression of his disease. Plus, as a bonus, most of his previous symptoms have been reversed. Search clinicaltrials.gov for multiple sclerosis chicago burt or go to http://www.StemCell-Immunotherapy.com or http://www.MarcStemCell.com or join http://www.Facebook.com/groups/burthsct/
Thank you!
Barb Coppins
NBC doing a report on positive stem cell developments would be great. Thanks for the comment, Barb.
Paul-
I also talked with the producers of this piece, and am surprised at the message about the FDA. To my knowledge, while the FDA is not actively enforcing the regulations in very many cases, the regulations remain the same. The FDA’s lack of action is being taken as a tacit approval of these procedures.
Clincaltrials.gov isn’t helping the situation either; anyone can get a posting on the government site by just getting IRB approval, which isn’t a very high bar. I learned only recently (from your blog) that just saying that you will observe the patients after you charge them thousands for a treatment is considered to be a clinical trial by the clinicaltrials.gov site.
This seems like a situation ripe for a sting.
Jeanne
I agree, Jeanne.