As I have been warning for years, the out of control stem cell wild west would eventually cause regulators to kill even low-risk cell therapies. That’s exactly what happened in Canada this week, where Health Canada issued a position statement saying that even bedside therapies needed drug approval. This is a big deal that should have most US doctors using orthobiologics to help patients avoid invasive surgery very worried.
The Stem Cell Wild West
We have been in total out of control mode here in the US for these past few years, but this got much worse this past year. Why? Multiple vendors of dead birth tissues began convincing alternative health practitioners and uneducated physicians that these products contained million of live stem cells. The number of those practices were scaled through both unscrupulous orthopedic sales reps and third party marketing companies.
The Health Canada Reaction
While the ability of Canadian physicians to offer stem cell treatments has been in limbo for a few years, the new policy statement ends all Canadian autologous stem cell use. The policy basically makes any cell therapy derived from the patient, even those prepared at the bedside, into a prescription drug that requires a Health Canada approval. So your bone marrow, which is minimally processed in the doctor’s office, can’t be used to heal your injuries until someone pays many millions to run a drug trial for each clinical indication for which it’s used. Contrast that to the U.S., where the very same procedure is permitted as a medical procedure.
Will these now required Canadian clinical trials ever really happen? For a few indications, the research will get done by others. For example, we have already published a randomized controlled trial using bone marrow concentrate for knee arthritis. There are also a few more studies at universities coming down the pike. However, Health Canada could play fast and loose here for many years, keeping these simple and inexpensive therapies off the market while giving the expensive cell drug market time to catch up. Which brings us to what’s really going on.
Using Regulation to Stomp Out Competition
There is no doubt that part of this decision was sparked by the out of control stem cell treatment space. However, given that bone marrow concentrate has been used since the 90s to treat orthopedic conditions, the sensible thing to do would have been to carve out a niche for that treatment. You could argue that regulators are more comfortable with an all or none approach than they are with incrementalism, as the latter breeds pressure from advocates from other therapies to be let under the proverbial regulatory tent.
Having said all of this, after observing this field for a decade and a half, there’s likely another factor at play here. Getting drug approvals to use the patient’s own tissues is expensive. Even if you mass produce someone else’s cells and bottle it like a drug, it’s still expensive. Meaning that these therapies will never be able to compete on price with things like platelet-rich plasma or concentrating the patient’s own bone marrow. So to preserve markets for these more expensive therapies that will be approved through Health Canada, an easy step is to outlaw the less expensive therapies. Is this good for consumers or taxpayers? Nope. In fact, it’s antithetical to their interests.
Could this Happen in the US?
The stem cell wild west is far worse in the US than it ever was in Canada. Right now the FDA says that it’s going after bad actors that are putting patient health at risk. So far this has focused on adipose stem cell clinics and umbilical cord “stem cell” vendors. However, it’s just a short hop and skip from where they are to the move Health Canada just made. While the current administration is anti-big government, in 2020 that all could change with a new administration.
The Media vs. The FDA and the Baby’s Bathwater
The media aren’t making the distinction between responsible orthobiologics use and irresponsible use. They view this like Health Canada, that things like bone marrow concentrate should be drugs and that the FDA is allowing a regulatory loophole. I’ve blogged this past week as to why that position is based more on a lack of education of how physicians innovate than on anything scientific or real.
The agency pushed back this past weekend against a New York Times piece that all but accused it of sleeping at the wheel. So, for right now, the agency seems to be dedicated to its risk-based strategy for cell therapy regulation, allowing low-risk therapies like bone marrow concentrate to exist while going after clinics that use high-risk therapies like adipose stem cells or umbilical cord tissue to treat neurologic diseases. Will that position change?
What Do Doctors Think about the Risk of the Health Canada Decision Bleeding into the US?
I ran a poll on Linkedin this past 3-day weekend and the responses were interesting. As of this morning, I had 76 responses from physicians and others in the field. 79% of the respondents were very concerned about Health Canada’s policy eventually influencing US regulatory policy.
The upshot? As I’ve been saying for years, physicians coming together to clean up the stem cell wild west is critical. In addition, now we also need to educate regulators and the media about responsible orthobiologic care. In the meantime, this move by Health Canada is a big concern, as it shows what happens when physicians don’t act to regulate themselves.