This was an interesting week. It ended with a conference in Las Vegas with me yelling at my colleagues about how they needed to tame the stem cell wild west and then an uninformed bench scientist in Vermont threw orthobiologics under the bus. The two events couldn’t be any farther apart, so I figured it was time to teach bench scientists about EBM in orthobiologics.
The ISSCR, Bench Scientists, and the Stem Cell Wild West
These days I have more in common with my bench science colleagues than not. The stem cell wild west has spun so far out of control that I’ve become one of it’s biggest critics. The ISSCR, the main stem cell bench scientist organization has also been beating that drum for more than a decade.
My medical colleagues and alternative health clinics are so out of control that I can barely even call what I see the Wild West anymore. We now likely have thousands of clinics that have popped up selling fake umbilical cord treatments and exosomes for just about every medical condition with a name. They are even targeting aging itself. There is no data that shows that what they’re using has any effect on these conditions. Most have no idea of what’s even in what they inject or the content on their websites as those are now often run by third party marketing companies. To call this the wild west seems not enough. It’s the world’s biggest medical scam that has existed in modern times. It makes the Laetriille cancer scams of the 70s look like they were selling Tic Tacs.
Understanding EBM and Logical Fallacies
One of the more frustrating things with the ISSCR bench scientist crowd is that they often fail to learn much about the existing orthopedics evidence base. Hence, when these stem cell bench scientists are quoted in news stories, they often lump orthobiologics in with the stem cell wild west. I suspect that this is because very few of them know much about the existing level of evidence in orthopedics much as I wouldn’t know about the existing level of evidence for how the hedgehog pathway does or doesn’t impact IPS cell differentiation. It’s just not something I look at every day.
Given that my bench scientist colleagues like to use the term “Unproven” for orthobiologics, logic would dictate that traditional orthopedic care must then be “Proven”. Regrettably, that’s where we have trained scientists using multiple logical fallacies. Here we’ll focus on one called Bifurcation (false dilemma).
The bench scientists only give reporters two options: that the science behind the medical care (in this case orthobiologics) is “Proven” or “Unproven”. This is a false dichotomy as there is a third option in Evidence-Based Medicine, the “Best Available Evidence”. This means that many times doctors and policymakers use evidence which is less than level 1 to aide treatment decisions. This lack of a Proven/Unproven dichotomy in real healthcare evidence has been acknowledged by experts trying to provide treatment guidelines for governments (1). So this concept is nothing new and is well established in Evidence-Based Medicine.
The Best Available Evidence and Orthopedics
If you apply the false dichotomy used by bench scientists to orthopedic surgery, it’s a mess. For example, a recent review in the British Medical Journal pegged 80% of orthopedic care as “Unproven” (2). One of my colleagues, Don Bufford, recently reviewed the top orthopedic journals and found that the average level of evidence for new orthopedic publications wasn’t level 1 or 2, but level 3. So the best you can do in orthopedics is to use “Best Available Evidence”. Hence, saying that orthobiologics are yet “Unproven” is fine, as long as you qualify that most of orthopedic surgery is similarly unproven. In fact, a university scientist not using that qualification would be disingenuous at best.
The University of Vermont Example
Orthobiologiocs recently got lumped in with the stem cell wild west when a University of Vermont bench scientist was asked about a local Regenexx clinic. He used the same “Proven/Unproven” false dilemma that obviously doesn’t apply well in orthopedics. This has happened numerous times where bench scientists have even thrown their colleagues across campus in the Orthopedics/Sports Medicine department under the proverbial bus.
So let’s examine his false dilemma against what the University of Vermont Health System says about orthopedic care online. The page clearly shows that the University of Vermont Health Network offers corticosteroid injections and viscosupplementation:
“Our providers offer advanced treatment options for non-surgical injuries and conditions.
Injectable cortisone is a powerful anti-inflammatory medication: a synthetically produced steroid that lasts for a longer period of time than the cortisone your body naturally produces. It is injected directly into joints such as shoulders, elbows, wrists, knees, and ankles to decrease inflammation, which can subsequently decrease pain. Cortisone injections usually work within a few days and the effects can last up to several weeks.
Viscosupplementation therapy is an appropriate treatment for people with knee arthritis that has failed to respond to more conservative therapy. We use an injection of hyaluronic acid called Euflexxa® for viscosupplementation.”
The problem? We have evidence that the cortisone (corticosteroid) injections used by UV health are ineffective for knee arthritis, their most common use and the injections can cause cartilage damage (3,22). Did the UV bench scientist know this medical literature, likely not. The evidence base for whether viscosupplementation (knee gel or hyaluronic acid injection) works is all over the map. Meaning most large meta-analyses say that the benefit is still unproven (4).
Interestingly, the current best available evidence would support what Regenexx offers for knee arthritis and NOT what UV offers. Meaning that we use Platelet Rich Plasma about 80% of the time to treat knee arthritis. We have 2 randomized controlled trials where PRP was used for knee arthritis and compared to a cortisone injection and found to be more effective (5,6). We also have 15 randomized controlled trials where PRP was compared to knee hyaluronic acid (HA) injection. In 13 of those, PRP was found to be superior to HA for the treatment of knee osteoarthritis (7. 8, 9, 10, 11, 12, 13, 14, 16, 17, 18, 20, 21). Two showed that the PRP worked about the same as HA (15, 19).
Hence, the UV bench scientist had his facts backward. The university he works for doesn’t offer “Proven” medical care for non-surgical treatment of knee arthritis, rather “Unproven” care that in one instance has been shown in randomized controlled trials to make the problem worse. What Regenexx is offering in Vermont is closer to the “Proven” standard or at least better than what UV Health offers based on the best available evidence. This is something the reporter totally missed, which is understandable given that the reporter relied on a Ph.D.
The upshot? We need university bench scientists to understand evidence-based medicine as it applies to orthopedics and orthobiologics. At this point, they ‘re clearly are not familiar with this literature. Instead, they’re committing logical fallacies left and right. For the average person who likely does this many times a day, this sounds like no big deal. However, since this is a group driven by science, I would expect them to learn and change from knee jerk reactions to actually providing quotes that fit the statement to the existing science.
(1) Gavine, A., MacGillivray, S., Ross-Davie, M. et al. Maximising the availability and use of high-quality evidence for policymaking: collaborative, targeted and efficient evidence reviews. Palgrave Commun 4, 5 (2018) doi: 10.1057/s41599-017-0054-8
(2) Lohmander LS, Roos EM. The evidence base for orthopaedics and sports medicine: scandalously poor in parts. Br J Sports Med. 2016 May;50(9):564-5. doi: 10.1136/bjsports-2016-g7835rep.
(3) McAlindon TE, LaValley MP, Harvey WF, et al. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA.2017;317(19):1967–1975. doi: 10.1001/jama.2017.5283
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(17) Buendía-López D, Medina-Quirós M, Fernández-Villacañas Marín MÁ. Clinical and radiographic comparison of a single LP-PRP injection, a single hyaluronic acid injection and daily NSAID administration with a 52-week follow-up: a randomized controlled trial. J Orthop Traumatol. 2018;19(1):3. Published 2018 Aug 20. doi: 10.1186/s10195-018-0501-3
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