According to The Bismarck Tribune and the AP/US News & World Report, the North Dakota Attorney General’s office is investigating a stem cell clinic in that state amid complaints. From the news articles:
“The clinic has been offering stem cell injections for about a week and a half. Consumer Protection Division Director Parrell Grossman says there are concerns about alleged misrepresentations and questions over whether all available information is being given to potential patients.”
A week and half is a short time so this particular state action seems relatively rapid compared to what we’ve seen in other states where clinics have been doing business for years without any steps by state officials.
Why is North Dakota investigating? The articles point to consumers reaching out:
“The investigation follows six consumer calls and two complaints handled by the attorney general’s office. The North Dakota Board of Medicine, the North Dakota State Board of Chiropractic Examiners and the North Dakota Board of Nursing received calls as well, Grossman said.”
The clinic views things differently, saying that the concerns were “unfounded and unfair.” Here’s more from chiropractor Dean Jones on their perspective:
“Dean Jones says there is a lack of information because no other clinics are offering this type of service in the area. Jones says he’s passionate about the field and disappointed by the investigation.”
I’m not clear on the facts of this case since the investigation is pending, but The Bismarck Tribune piece has further details and identifies the apparent firm in question: “The subject of the formal investigation is West 2 North Medical Solutions.”
A Google search indicates that the company is the focus of some YouTube videos (see screen shot from one above including Jones) and other material on the web. In another video on the business, text below it refers to “the miracle of Amniotic stem cells.” From what I could see on the web, this is an amniotic stem cell business that has 5 locations in multiple states including North Dakota, Colorado, and California.
The Bismarck Tribute also reported even more specifics on the issues raised:
“Some complaints allege people attending seminars in Bismarck and Minot were told the clinic’s treatments could help with any ailment and that injections work better than surgery. Grossman said the clinic’s stem cell treatment does not appear to be approved by the U.S. Food and Drug Administration, which wasn’t disclosed during the seminars.
Other complaints allege the seminars misstated prices for services that cost thousands of dollars, and that the clinic engaged in high-pressure sales calls. There also were reports that employee Dean Jones, a chiropractor who isn’t licensed in the state, has represented himself as a medical doctor, Grossman said.”
The description of these alleged complaints about the stem cell clinic fit with the kinds of things I’ve heard over the years more generally about possible clinic issues. For instance, see my journal article on what I call stem cell infomercials and the stem cell hard sell. Note that the reported complaints in the North Dakota situation have not been independently confirmed by The Niche. Gross was also quoted in The Tribune, “”While we await the results of our final investigation, we are initially very alarmed about the information we have learned to date,” Grossman said.”
To date overall most states and their medical boards have apparently done little or nothing, positively or negatively, regarding the stem cell clinic industry firms within their borders. Still, stem cell clinics are garnering more state attention for various reasons and two states, California and Texas, have passed laws directly bearing on stem cell clinics within their borders. Interestingly, the laws in those two states are somewhat opposite in intention in some ways with California focusing more on consumer protection and Texas so far more on the right of businesses to practice and patients to take risks. Although, as I’ve written in the past the original bills that ultimately morphed into the Texas law started out much worse, they now contain at least some protections due to the hard work of folks like David Bales, who led an effort to have responsible legislation.
Overall, the amniotic stem cell sector of the for-profit clinic arena is growing quickly and we need data on it to provide a more concrete sense about what is going on relative to other stem cell clinics. We haven’t seen the FDA take any actions or say a whole lot on amniotic stem cell businesses so there’s past track record to go on, and more broadly the FDA hasn’t done much in recent years about the around 600 stem cell clinics in the U.S. Given the more assertive tone of the agency under new Commissioner Scott Gottlieb, that approach to stem cell clinics could change. The next 1-2 years should tell us a lot about the FDA’s direction overall on stem cell businesses that market directly to consumers. Given the trend for more stem cell clinic patients to view themselves as consumers, do reviews online, and be more vocal, this can be another source of information, but sometimes the clinics tap into that review stream themselves.
One of the bigger areas of uncertainty is whether amniotic clinics are using living amniotic cells or simply extracts of amniotic membranes (see Wanted both dead & alive), and if they are using living cells, are those cells really stem cells? If no living cells or no live stem cells are being used, some clinic marketing may be misleading as some patients get the impression that the therapies have live stem cells. My reading of the recent FDA finalized guidances is that many uses of amniotic “stem cell” products are most likely going to be considered use of “drugs’ requiring agency pre-approval, but I’m not 100% sure about that. Further, to know how the various regulations would apply, the amniotic products at specific businesses would need to be analyzed.
Back up in North Dakota specifically, we’ll have to wait and see how the investigation goes to get further clarity about the alleged issues there.
First, no consumers called to complain, it was a few competing physicians from local orthopedic groups that were concerned about their livelihoods relative to providing unnecessary joint replacements and surgery. Second, there are no stem cells in commercialized amniotic fluid, which clarifies commentary in several of your articles. The product they marketed in ND was a cord blood and amniotic membrane product from UCB called Stemshot, which is more like @&$&shot and contains no live cells. @&$&shot is a decent cord blood and amniotic product even though it’s not currently FDA compliant.