As you may know, we have been successful in getting self-funded health plans to add interventional orthopedic procedures that use orthobiologics. This has been met by many companies with open arms, as they are increasingly struggling to control exploding healthcare costs. For orthobiologic naysayers on the university bench scientist side, this development has been concerning as they want to develop a narrative that these procedures are experimental. Recently Kaiser Health News produced a syndicated piece (which has appeared in Time and elsewhere) on the issue that was interesting and full of internal contradictions. Let’s dig in.
A self-funded health plan is what most medium-sized to large companies use instead of the type of private insurance you and I would purchase. This type of health plan involves an employer hiring a third party to administer its payment of medical bills and to provide a network of doctors. However, the company pays the bills directly. Because companies can move at a much quicker speed than large insurers like Blue Cross Blue Shield and United, this is where most of the cost savings in American health care happens. Meaning, when new cost savings experiments happen, they most often happen on the self-funded plan side.
Regenexx and Health Plans
Way back in 2014-15, one of our network sites in Iowa began a pilot program with some local companies to determine if they could save money by replacing invasive and expensive orthopedic surgery with less invasive and less expensive orthobiologic procedures. These were mostly platelet-rich plasma injections with some bone marrow concentrate (same day stem cell) procedures. The pilot was very successful at saving money and many employees loved avoiding surgery. This then expanded into the Regenexx Corporate program. These are the logos of the companies we currently work with:
We also have many more healthcare interventionalists (not shown).
Getting Caught Up in a Reporting Narrative
Regrettably, due to the hyper-speed of Internet reporting and market segmentation in the news media, we now have very few news stories seeking to report both sides of every issue. Why? That takes lots of time and most news outlets are now serving a small segment of the population that want to read specific stories with a certain point of view. Hence, most pieces are written to serve a specific narrative before the interviews begin.
For us, we had a New York Times article written this way and now one by Kaiser Health News (KHN). I’ll dig into the latter since it’s more recent. KHN contacted us two months ago and it was very clear very early that the reporter had an agenda. Meaning, our corporate clients all complained about the tactics being used by the reporter. Hence, we only agreed to answer written questions.
While there were two email exchanges (the first is here: Regenexx Responses to Kaiser Health News Questions Part 1), the second is perhaps the most telling:
Question: How do you respond to patients who continue to have significant pain or problems functioning after treatment?
1) Reporter: “I talked to a few people who had stem cell (bone marrow aspirate) for knee pain, for example. One said he got very little relief from the injections, and later had both knees replaced, which appears to have completely resolved his pain. Another had injections in her knee, and later had surgery on both knees.”
Regenexx: First, know that a science writer would NEVER cherry pick patient procedural results to fit a predetermined narrative. First, understand that we use bone marrow concentrate and not bone marrow aspirate as you relay. We also don’t know if these patients received our BMC procedure or a different procedure. Regardless, we transparently publish the outcomes from our treatment registry live, online here: https://regenexx.com/results/live-patient-outcomes/.
With regard to our knee arthritis procedure, our last analysis of registry data on our bone marrow concentrate procedure demonstrated that 69% of patients at 5 years reported meeting the MCID (Minimal Clinically Important Difference) for the IKDC functional questionnaire. In our published RCT (see https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-018-1736-8), 69% met the MCID for the KSS Fxn score at 2 years. This means that less than a third didn’t respond to the procedure. In an earlier analysis of our registry data, only 14.8% of patients converted to knee replacement at 1-2 years after having a Regenexx procedure. Hence, the failure rate for our knee arthritis procedure is publicly available and widely known. Dr. Centeno has also blogged extensively on patient failures. Here are a few examples:
Persistent pain after knee replacement is surprisingly common. As a journalist, it would be critical to report that in one recent study, nearly 40% of patients reported that they still had persistent pain at one-plus years following knee replacement surgery. The median average pain rating (using the 0-10 numeric pain scale) was 3 out of 10, with pain reported as high as 5 out of 10 (see https://www.healio.com/orthopedics/journals/ortho/2016-1-39-1/%7B90c9f37e-7f11-
Regarding the anecdotal patient stories you shared, we’d like to add: “we are disappointed to learn of patients who didn’t have a positive outcome. Our goal at Regenexx is to achieve the best possible clinical efficacy, and we are actively researching to find out why some patients respond better than others.
2) Reporter: “One man had injections for shoulder pain, and said his shoulder is actually worse a year later than before the Regenexx.”
Regenexx: Again, we publish all of our registry results transparently online: https://regenexx.com/results/live-patient-outcomes/ With regard to our shoulder rotator cuff tear procedure, the registry data shows that 72% reach the MCID for the DASH functional questionnaire at 24 months. In our first analysis of our shoulder rotator cuff RCT data, (attached) that was just submitted for publication, 10% didn’t meet the MCID for the DASH functional questionnaire at 24 months. While reporting more pain is a possibility for any procedure, our safety study on more than 3,000 procedures followed for up to 9 years demonstrated that just 2.3% of patients (in all body areas) reported pain as an SAE post-procedure (see https://regenexx.com/wp-content/uploads/2019/02/2016-Safety-Report.pdf). Hence, treatment failures for shoulder rotator cuff tears do occur and increased pain after a procedure is possible, but rare.
As a journalist, it would be important to note the following about rotator cuff surgery. First, we don’t have convincing data that rotator cuff repair is more effective than physical therapy (see https://annals.org/aim/fullarticle/745977/systematic-review-nonoperative-operative-treatments-rotator-cuff-tears and https://www.ncbi.nlm.nih.gov/pubmed/24395315). Second, failure rates for rotator cuff surgery have failure to heal rates of 14-57% depending on age, and re-tear rates as high as 34%-94% (higher for larger tears).”
Of course, none of this detail made it into the KHN piece, clearly showing that the story was written well before any questions were asked by the reporter.
The KHN piece quotes a patient who was possibly told that a bone marrow concentrate procedure would regrow cartilage? Our website is filled with references to the fact that bone marrow concentrate procedures don’t regrow cartilage in severely arthritic knees. This one was just published last summer: Will Stem Cells Regrow You New Cartilage if You Have None? Nope. Hence, had the reporter asked or had she just done a simple search of our website under “regrow cartilage” as I just did, she would have seen that this is NOT our position.
Where Are The University Physicians Who Use Orthobiologics?
One of the things that have been absent from all of these recent stories attacking orthobiologics are the quotes from university physician-scientists who use orthobiologics. Obviously, it would be the responsibility of every reporter to get both sides of the story. Meaning if you quoted university scientists who opposed orthobiologics, you would then need to get a quote from a university scientist who used these injections like PRP and bone marrow concentrate in their daily practices. This would be a requirement, not an option.
As an example, it’s bizarre that we have a scientist from Pitt commenting negatively about orthobiologics who is unopposed in the KHN piece. This is doubly true because an orthopedic surgeon from the University Of Pittsburgh, James Bradley, M.D. uses PRP and bone marrow concentrate and just received the NLFPS award for scientific research in PRP. He’s been the Head Team Orthopedic Surgeon of the Pittsburgh Steelers for three decades and is a past president of the NFL Physicians Society. Again, if there was a Pitt ortho that used orthobiologics and had a different opinion from the one you sourced, wouldn’t it be your responsibility as a reporter to know that and get a quote? A simple Google search would have discovered that fact. I guess no such Google searches were performed for this article.
So far, as discussed, we haven’t seen reporters balance a story with university physicians who use orthobiologics. For example, a number of physicians have organized a Delphi panel to define the elements for responsible orthobiologics use. Meaning what are the best practices to use orthobiologic therapies?
A Delphi panel is a consensus building method developed by the RAND Corporation. It’s basically a series of questionnaires that experts answer and then review to see what their colleagues think. The goal is to drive a consensus of the experts to produce guidelines.
To date, we have physicians on this panel from Stanford, the Mayo Clinic, Emory, Harvard and many other universities that all use orthobiologics on a day to day basis. Where are quotes from these physicians? Nowhere to be found. Again indicating that the KHN piece was a preset narrative and voices that would have changed the narrative couldn’t be included.
This same KHN reporter has recently thrown university physician-scientists under the bus for using orthobiologics. Hence, it’s not surprising that she omitted those voices from these stories. Apparently quoting one side of campus (bench scientists and bioethicists) is better than quoting the other (university physicians).
The Ultimate Irony
Wouldn’t it be a hoot if the Kaiser Health System had physicians that used orthobiologics and used surgical procedures we knew were ineffective? Well, that’s all reality. PRP is used by some physicians in the Kaiser Health System, so in full disclosure, KHN should note this in any piece on orthobiologics. In addition, the Kaiser Health System continues to perform partial meniscectomies, so the piece should have noted that surgeons at Kaiser don’t necessarily practice evidence-based medicine. Meaning this procedure has been shown to be ineffective and no better than placebo or physical therapy in at least 3 large RCTs, so the Kaiser Health System is clearly not practicing what KHN preaches (Kaiser Health News states that it is separate from the Kaiser Medical System).
Leading the Way is Tough
Regenexx has been leading this field of orthobiologics for a decade and a half. That’s meant lots of positive and some negative press. However, as we knew with the KHN piece, there was nothing I or anyone else could have said that would have changed the pre-written narrative of this story.
One of the things that science reporters have trouble understanding is the stark differences between how physicians innovate and how bench scientists develop drugs. This KHN piece also misses this issue. Why? Science reporters are used to covering drugs and not new surgical procedures.
The upshot? It will be interesting to see how the preset media narrative evolves. Clearly, nobody is trying to write a balanced story, which is regrettable. We help thousands of patients a year avoid surgery and save big money for many companies. We have always been transparent about successes and failures, just as traditional orthopedic surgery produces successes and failures. Like many physicians that offer orthobiologics, my Colorado office is filled with orthopedic surgery patients who didn’t respond or are far worse because of their more invasive procedures. So we’ll continue offering these therapies in our mission to help patients substitute less invasive interventional orthopedic procedures for more invasive orthopedic surgeries. The funny thing is that 3-5 years from now when we begin to see the first large carriers like United begin to cover many of these orthobiologic procedures, I’ll have a stiff drink and a big chuckle.