Why Can't Universities Take the Lead in Orthobiologics?
POSTED ON 6/10/2018 IN Research BY Chris Centeno
This past week, a patient was in for treatment who hailed from Silicon Valley. While I see patients from all over the world, this patient's story is important. She had seen smart physicians at her home university, none of whom could help her. Why? They insisted on following the herd rather than leading the pack. Let me explain.
My Patient's Story
My patient is the wife of a biotech entrepreneur who has started and sold many companies. She herself was very accomplished in the healthcare tech space. So when she started getting severe cervical radiculopathy (a pinched nerve in the neck from a disc bulge), she sought out some of the best doctors the bay area had to offer. Like many in the area, she made a pilgrimage to Stanford. As a very prestigious university and medical school, Stanford sits in the heart of the world's innovation hub. They should have offered this patient a state-of-the-art treatment for cervical radiculopathy. Something so revolutionary that, like an iPhone or Google's AI, it would have redefined treatment for the diagnosis. What did she get? The same old high-dose corticosteroid injection that she could have received in rural America. The origin of that cervical epidural as a treatment for a pinched nerve in the neck tells the story of why Stanford or many other US universities will never lead in orthobiologics.
The Story of Epidural Steroids Shows Us That Universities Are Structurally Incapable of Leading in Real-World Medical Breakthroughs
Back in the '80s, the standard treatment for a disc bulge in the neck or back was surgery. In fact, the only other options were oral medications or physical therapy. The medical breakthrough (epidural steroid injections) that has allowed millions of patients since to avoid neck or back surgery wasn't birthed at a university. In fact, it was popularized by two brothers with a private practice in Stanford's backyard, and it would be another two decades before the universities even began to notice that the paradigm had shifted. The idea that you could inject high-dose steroids directly into the area around an inflamed nerve instead of getting surgery was begun by the Saal brothers in Daly City, California. It was also used early on by luminaries like Charlie April in Louisiana and Rick Derby of California. What did all of these guys have in common? They were private-practice physicians. In fact, the major universities didn't catch on that you could treat a patient this way until the early 2000s. Why? Aren't universities supposed to innovate?
We usually think of universities as having an almost religious type calling for the advancement of science and bettering the human condition in medicine. However, these days, the average university is like a massive for-profit corporation. It's as focused on what brings dollars into its coffers as Coke, Pepsi, or Apple. There are two ways a medical school can make big money. One is by licensing its basic science discoveries. So when a biology professor discovers that you can make embryonic-like stem cells from adult skin cells, that discovery and its patent can be licensed to a private company. Another way a university can cash in on medicine is by running clinical trials for private companies. So when a private venture wants to get FDA approval for using fat stem cells to treat knee arthritis, a university can charge millions to perform the FDA-approval trial. How about university physicians trying new things? After all, this is the other arm of discovery that has brought us everything from test-tube babies to modern trauma care. In these cases, University Inc. usually stands in the way. As an example, I have heard many of my university colleagues lament that simply adding platelet-rich plasma to their practices can be a struggle because there is no insurance reimbursement code. In addition, universities generally frown on their physicians going off script and trying new things before they have been paid to generate the evidence that this procedure works. So universities are incented to discover new drugs and to run clinical trials on someone else's discovery, but university physicians are not incented to innovate on the ground. This brings us back to my patient. She got a therapy that was invented in the '80s by a private-practice physician across town, while Stanford's only option was performing neck surgery. When Stanford finally caught on that this procedure worked (two decades too late), they clung to it like a warm safety blanket, while many private-practice doctors have long since moved on to using orthobiologic therapies in the spine.
What Finally Helped My Patient and What She and Others with Influence Can Do to Fix University Inc.
We invented the use of platelet lysate (PL) to treat radiculopathy. We're now on our fourth-generation procedure and have honed not only the mix that gets injected but also how it's best applied and where it does and doesn't work. This might as well have been some sort of magic to the pain-management guys at Stanford and many other universities, but where their steroids did nothing to help this woman, a single fourth-gen PL injection around those same irritated nerves dramatically reduced her symptoms. Is this magic? Nope, merely good science. PL contains many helpful growth factors and cytokines and is anti-inflammatory, where PRP usually causes some level of inflammation. To learn more about PL, see my video below:
So how can my patient and others like her influence University Inc. to start allowing physician-based innovation? Money talks at Stanford and everywhere else. Here are some ideas tied to donations:
- Physician Innovation Centers: These are places where doctors are encouraged (rather than discouraged), with proper informed consent, to offer therapies that are not standard of care or don't yet have good evidence as part of a clinical case series.
- Fix University Physician Bonus Structures: I have heard from several university physicians (who do offer cash-based orthobiologics) that it's a nightmare to get these cash-based therapies approved by their organizations. Without an established insurance reimbursement code, university paymasters often have no way to calculate physician productivity.
- Silence the Bench Scientists: The university bench scientist lobby has become very active this past decade by seeding news stories to the media that seek to block physician-based innovation. Why? It hurts basic science grants coming into university coffers. Take stem cells for example; why do we need the 100th research study on the hedgehog pathway in mesenchymal stem cells (MSCs) when a university physician across campus has already perfected the use of MSCs to treat arthritis?
If University Inc. can't be fixed, then there's always another option. As we have shown, an academically focused private practice can get more done with private donations in a year than universities can accomplish in ten. As an example, donations from philanthropist John Malone allowed us to create the platelet lysate mix that we used in this patient. Why? We have none of the bureaucracy; we do what makes sense, using all of the same informed consent and research methodology as a university. As a private practice and private company, we have also long since eclipsed the publishing activity in orthobiologics of any single university and established our own fellowship program. The upshot? University Inc. is hopelessly behind in orthobiologics. While they are now getting paid big bucks to study someone else's discovery in platelets or stem cells, they can't innovate in this area themselves to save their lives. This is often not their fault, but instead a problem of a bureaucratic and fiscally focused machine that fights physician-driven innovation at every turn. If we want this fixed, it will take people who can influence university policies through the one thing that always talks to University Inc.—money. If it can't be fixed, then philanthropic dollars should find homes outside of the university machine.
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