August 15, 2020

The Niche

Knoepfler lab stem cell blog

Reprimand, $13K fine for bone marrow stem cell clinic doc

Dr. Matthew Thorson bone marrow stem cells
Dr. Matthew Thorson, a pain doc who received a reprimand from a Minnesota State Medical Board related to his offerings of unproven bone marrow stem cell offerings. Photo from clinic website.

A Minnesota doctor running a stem cell clinic offering bone marrow injections for a variety of health conditions was subject to action by state medical regulators. The Star Tribune’s reporter Jeremy Olson has a new article on the action, which included a $13K+ fine.

Pain doc gets attention of state regulators

Olson’s piece has some of the key details:

“Dr. Matthew Thorson was reprimanded late last year after the Minnesota Board of Medical Practice received complaints that his Stem Cell Centers of Minnesota practice made marketing claims that haven’t been proved in research and paid recruiters per patient they steered to his clinic.”

This sounds all too familiar for the stem cell clinic arena, but it’s more unusual for a bone marrow clinic to get dinged in this way. Fat stem cell and birth-related clinics and suppliers have been subject to most action. Olson’s article included some explanation from Thorson on what happened:

“In an interview, Thorson acknowledged marketing mistakes by an agency that he no longer employs, but said the stem-cell injections and other forms of regenerative medicine he offers are at least safe. They also have reduced pain, increased mobility and prevented or delayed surgery for many of his patients, he said, even if medical research on those benefits is limited.”

That doesn’t sound very convincing to me.

The action by the Minnesota Board against Thorson lists a number of concerning issues. There were reportedly six complaints filed against Thorson in less than a two-year period.

What does the FDA think of bone marrow stem cell clinics?

The FDA has been slower to clarify its rules related to clinic use of bone marrow-related products. While such products seem to not trigger the FDA’s “more than minimal manipulation” standard for drug classification and often are not necessarily defined from the get-go as drugs, it sure seems like many clinics are conducting non-homologous use procedures using bone marrow products, which in theory should trigger a drug classification as well I would think.

However, the agency has been vague about the extent to which non-homologous use applies to bone marrow products. For instance, if you inject bone marrow cells into somebody’s eyes or nervous system, which clearly seems like non-homologous use to me, is the product a drug in that case?

Bigger clinic problem across U.S.

The total number of American stem cell clinics remains in flux. Long-time stem cell clinic critic Leigh Turner is quoted in the article that he hasn’t so far seen much drop in clinic numbers since the FDA stepped up actions in the last couple years:

“You might sort of think, ‘OK, this is a market that is going to shrink now that authorities have caught on.’ Instead I’m seeing the opposite,” said Leigh Turner, a University of Minnesota bioethicist, whose 2016 report on the market for unapproved stem-cell treatments spurred federal regulators into action. “It doesn’t seem to be having any kind of significant effect on the marketplace as a whole.”

My recent study found that some types of clinics appear to be particularly prone to shutting down, rebooting as some other business, or stopping marketing of stem cells. However, so many new clinics are opening up that along with clinic operators rebooting under new firm names, it’s hard to keep track.

In Minnesota alone there are many clinics:

“As many as 13 clinics in Minnesota and hundreds nationally provide therapies that pledge to use the regenerative qualities of stem cells, even though the therapies haven’t gone through the same rigorous federal approval as prescription drugs.

Minnesota’s providers range from independent practitioners such as Thorson to the Rejuv clinics in Savage and St. Cloud that partner with Regenexx, a Des Moines-based national stem-cell company. Mayo Clinic and Twin Cities Orthopedics (TCO) have gotten into the market as well.”

What is Mayo Clinic doing in the mix here?

That last part in the article about the Mayo Clinic is also concerning to me and to others in the field. Mayo’s own study didn’t find a significant benefit from stem cell injections for knees, but they apparently still market it anyway for some unknown reason:

“Mayo sought proof of effectiveness through a randomized clinical trial — giving arthritic patients stem-cell injections in one knee and non-medicating saline injections in the other. Neither doctors nor patients knew which knees received the stem cells. The trial failed to prove effectiveness because patients saw equal levels of improvement in both knees.

Even so, Mayo still offers the therapy, which is probably suitable for middle-aged adults who won’t benefit from physical therapy alone but aren’t ready for joint replacement yet, said Dr. Shane Shapiro, medical director for Mayo’s regenerative medicine program at its Jacksonville, Fla., campus.

“We try and counsel patients on the best treatment options,” he said. “We really don’t push these treatment options at all.”

So why offer it at all at this point and charge for it? I wish they wouldn’t unless they have a study that is more convincing first.

Unfortunately, some clinics point to Mayo being in this space as justification for what they are doing.

The bigger picture

It’s clearly getting riskier for stem cell clinics and their suppliers the last few years. They are increasingly likely to be subject to actions by state or federal regulators. This is only likely to increase in November when the FDA’s 3-year grace period of a sort ends.

The bottom line though is that it’s not clear if all these state and federal actions are going to make a meaningful dent in the massive marketing of unproven stem cells in the U.S. Some kind of more assertive action seems necessary by regulators in the most extreme cases where, for example, the product in question is clearly a drug and has harmed patients.

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