A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example.
He started off with a description of the kind of hopeful feeling that many patients experience upon visiting stem cell clinic websites:
“Visitors to the website of StemGenex, a La Jolla medical group, could be forgiven for thinking that the answer to their prayers is finally at hand.”
However, there is little published data to support the expectation that one’s prayers might be answered at U.S. stem cell clinics today. I talked with Hiltzik about the state of the American stem cell clinic arena and my concerns as he was researching his piece. The marketing of stem cells is too aspirational in my view and patients are sold medical interventions in many cases that may not work and have potential risks. Hiltzik writes (emphasis mine):
“StemGenex’s director of media and community relations, Jamie Schubert, told me that its “principal purpose is helping people with unmet clinical needs achieve optimum health and better quality of life,” and that it has “anecdotal feedback … from our patients that their symptoms have dramatically improved and their quality of life has substantially increased.”
Keep in mind that we are talking about hundreds of clinics in the U.S. injecting living stem cells into patients’ bloodstreams or into specific tissues and most clinics out there do not have FDA approval to do this so anecdotes are not a strong foundation for this kind of practice in my opinion.
Some argue they don’t need FDA approval, but regardless there should be rigorous data to support such medical interventions to at least lower risks and increase the odds of benefits. Instead in most cases for clinics across the U.S. there are mostly vague impressions and feelings from the clinics that what they are doing might be helpful and isn’t harmful.
Hiltzik also discusses some FDA issues as they relate to stem cell clinics and recounts the case of the Irvine Stem Cell Treatment Center run by Dr. Thomas Gionis as well as two other co-owned clinics that together received a warning letter last December.
Then the article focuses again on StemGenex including his reporting on the clinic’s claim of accreditation:
“StemGenex claimed on its website to be accredited by the Accreditation Assn. for Ambulatory Health Care, which provides seals of approval for outpatient surgical facilities. It’s not. StemGenex removed the references to the AAAHC from its website after we asked about them; the AAAHC also issued a cease-and-desist letter. StemGenex says the references were “outdated.”
So could clinics like StemGenex help people and what about some patients sometimes transiently feeling better after getting “treatments”?
In part brief periods of feeling better could be a placebo effect at work. We need solid data from controlled studies to be sure. Hiltzik recounts the case of a customer Vivian Sjodin who has paid almost $30,000 for treatments at StemGenex, but whose possible perceived benefits he says reportedly faded over a period of months.
This not only raises the issue of the high cost of stem cell treatments at clinics, but also the fact that many businesses want their customers to keep coming back for additional stem cell purchases.
In the lead up to the September FDA stem cell meeting we can expect to see more attention by the media on stem cell clinics and that’ll be a good thing in terms of educating us all about what is going on in that industry. Note that Stemgenex and other stem cell clinics are amongst the many speakers on the agenda. Let’s see what everyone has to say.