I’ve been involved with treating knee arthritis with stem cells likely longer than anyone on earth. In that time, I’ve seen it all. First, you can bet that every 3–6 months, there will be a negative article about clinical stem cell use in general. This all tends to ebb and flow, but it’s also as predictable as the tides. So the recent Wall Street Journal (WSJ) article on stem cells was actually a pleasant surprise.
Academia as Big Business
First, while it’s hard for science writers to comprehend, academia is big business. The endowments of just a handful of the richest universities are bigger than the amount of cash on hand that runs the US government. In addition, University Inc. has numerous big institutions that are businesses equal in size and operating budgets to the world’s largest corporations, like Coca-Cola.
The academic machine takes its vig from every government grant, private donation, or company payment. These “administrative fees” would make Vinny and Carmine blush. They are usually 35–50% of all money coming into a university for a specific project. Hence, academia fuels itself by taking a huge chunk of every dollar used for science.
Hence, anything that threatens the amount of money inbound is bad for the business of academia. Take, for example, the grant money coming in for stem cell basic science research. Academic bench scientists have long pushed back against the clinical use of stem cells for one clear reason: their own pocketbooks. Grants not only run the academic machine, but they also help pay professor salaries and the army of labor that does the actual science. To see how effective this group has been at milking the grant cow, all you need is a simple PubMed search. For example, right now, in the US National Library of Medicine, we have 52,287 research papers published on “mesenchymal stem cells” (MSCs). Given that publishing activity correlates generally with how much we know about a topic, compare that to 17,960 for the well-characterized drug amoxicillin, first discovered 58 years ago in 1960. Let that swirl around in your noggin for a minute. We have three and a half times more data on MSCs than we have on a 58-year drug that saw its first FDA approval in 1972! Yet, to date, we have no FDA approval for MSCs. To say that the academics have been successful in extracting every last grant dollar available on this topic is an understatement.
Another huge line item on any large academic medical center’s bottom line is clinical trials. Large trials can cost tens of millions of dollars. Hence, the final way academia can profit from stem cell research is to perform the clinical trials needed to pursue FDA approval on technologies that require drug status.
In the end, I have no real problem with any of this; it’s all the free market at work. In addition, more research is always better than less. However, the only issue is that science writers never discuss the financial incentives behind academia. They always seem to skip that obvious conflict of interest.
The Stem Cell Wild West
A long time ago, I coined the term, “Stem Cell Wild West.” Year over year, treating orthopedic injuries, like knee osteoarthritis (OA), with stem cells has gotten more and more out of control. I have continuously cited and exposed systematic consumer fraud happening on a national scale. Hence, on the other hand, I don’t blame science writers for quoting academics about how the stem cell treatment space needs more and not less regulation. For more info, see my video below:
What the Wall Street Journal Got Right
It was a breath of fresh air to see a science writer finally realize that academics are treating knee arthritis with stem cells. While the bench scientist set has been screaming at the rain, pitching negative news stories about clinical stem cell use (many of which are justified), across campus, for years, the physicians in the orthopedic surgery, pain, sports medicine, and physical medicine departments have been treating patients outside of clinical trials using FDA compliant, bone marrow stem cell therapies.
However, this is America. No self-respecting university is going to turn down the big bucks it can earn through performing clinical trials; hence, the WSJ article also commented on the ongoing studies that companies are performing in technologies that are not yet FDA compliant. While the casual reader may not have picked this up, the WSJ outlines the difference between the regulatory status of bone marrow and fat stem cell therapies. For example, the procedures that are being used right now to treat knee arthritis by academics are bone marrow based. On the other hand, everything quoted as being “research only” was fat based. This is because the use of fat stem cells to treat orthopedic conditions is not compliant with the current laws without full FDA drug approval.
Academics Sometimes Follow Rather than Lead
Many patients believe that their local, big academic medical center is in the lead in all areas of research and care. However, in stem cells, like in some other areas, like pain medicine, they have been behind. Why? The first physicians to use this technology were in private practice and not in large academic medical centers. A great example is our practice, that began using stem cells to treat knee osteoarthritis in 2005. At the time, no academic medical center was doing anything like that. In fact, most wouldn’t get on the bus until about 2013. By 2015 we had published significantly more research on the clinical use of orthopedic stem cells for knee OA than any academic medical center.
Another example of following rather than leading is that the WSJ article mentions technologies being studied that we have used here and ex-US for years, some of which we have abandoned because the results were not better than bone marrow. For example, our 2014 paper where our research group reported our registry data that demonstrated that bone marrow plus fat was no better for knee OA than bone marrow alone. So in this case, the academics are years behind.
The upshot? I was more impressed with the WSJ article than anything. It showed that many academics consider stem cells ripe for use to treat knee OA and use the technology right now in their own patients outside of clinical trials. In addition, academic medical centers make money by performing clinical trials, so they’re also not about to give up on a huge gravy train of funding. Hence, they will continue to both use and study the use of stem cells to treat knee arthritis.