The Bench Scientist False Dilemma

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I’ve blogged a few times about the widening rift between a handful of media-savvy bench scientists and physicians who use regenerative medicine techniques to help patients avoid invasive orthopedic surgery. This past few weeks we’ve seen several unscientific things in the news and in bench science blogs about PRP and Bone Marrow Concentrate. These arguments force a false dilemma that needs discussion. So what’s up? Let’s dig in.

What Is a Bench Scientist?

Bench scientists are usually Ph.D.’s who work on basic science. In the world of cell biology, they often work with stem cells. Unlike other fields, their basic science discoveries can often lead to patents that can be used by universities to earn income. While that may seem strange, ever since the Bayh-Doyle act of the 1980s, universities can use your tax dollars in the form of NIH or other government grants to discover and then commercialize technologies and keep the profits. That’s why you’ve seen large university-run business complexes sprout up just outside college campuses all over the U.S. Hence if you’re in a bench science field working with stem cells, your discoveries could become a cash cow for you and the university.

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The Bench Science Organization that Pushes a Narrative

ISSCR is the International Society Stem for Cell Research. While most ISSCR members are just scientists working with stem or other cells, some in this group became very politically and media savvy during the Bush II embryonic stem cell ban. That made sense, as all of a sudden, government regulations took a swipe at the research these scientists were performing. However, as that ban was lifted, the organization’s leaders began to focus on stem cell clinics. Hence, most of the negative stories you see in the press are launched by the last ISSCR meeting. How? Its leadership has learned how to play the media like its own personal violin.

Is this a bad thing? Not necessarily. Remember, the ISSCR is one of the organizations that has helped the crackdown on the stem cell wild west. However, for certain members, the notoriety that comes from being quoted in a national news story is just too much to give up, hence they have now moved that target of their ire from crazy clinics to the scientifically supported orthopedic use of PRP and Bone Marrow Concentrate. Hence, right now, we have basic scientists acting against the existing clinical science.

The Recent Anti-PRP Media Thrust

A recent news story entitled, “US stem cell clinics boomed while FDA paused crackdown” is a great example of the recent thrust by bench scientists to attack the field of orthobiologics. This is a quote from that article:

“In 2018, Stringham was looking for an alternative to surgery for chronic pain in his right shoulder and elbows after years of weightlifting. He paid $2,400 for injections of so-called platelet-rich plasma at a clinic…

The procedure went smoothly, but within hours Stringham was wracked by pain in his back, shoulder and arms.

“It was a crazy amount of pain and I kept calling them saying ‘something is not right,’” said the 51-year-old. ”And to this day I’m not right.”

The clinic gave Stringham medication for the pain and told him to be patient. But things didn’t improve, even after months of physical therapy. Since then, a neurologist has told Stringham he probably suffered nerve damage at the places where he was injected.”

Where are the dangerous stem cells? Not to be found here, as this patient’s story is about PRP. This attack on PRP is bizarre, given that we have dozens of randomized controlled trials that show the safety and efficacy of platelet-rich plasma(4-51). In addition, there are about a dozen RCTs showing the efficacy of PRP injection for chronic elbow epicondylitis and shoulder pain. In fact, we now have more data supporting PRP use compared to placebo or conservative care than any orthopedic surgery this patient could have received for his shoulder and elbows.

Is there any research that supports that PRP causes nerve damage? Nope. While a single unguided needle placed in the wrong spot could have caused a mild nerve damage event, the likelihood that you could get serious nerve trauma in all of these places is infinitesimally small. In fact, we have 4 RCTs that show efficacy for PRP when used to treat nerve injuries like carpal tunnel syndrome (1-4).

More concerning is this statement from the article:

“His case was included in a Pew Charitable Trusts review of 360 reported injuries from stem cell and other regenerative procedures between 2004 and 2020. Nearly all the reports came from medical journals, government publications, social media or news reports. Just five came from FDA’s database for medical injuries.”

What is this? This is an unscientific collection of complications due to various types of cell therapy and other treatments used for various medical conditions without any data on the number of treatments performed to generate 360 complications. Meaning, any reasonable doctor or patient would know that you report a rate of complications. For example, there’s a 5 in 100 chance that this specific surgery for this specific medical condition will produce an infection that may require hospitalization. That type of basic information regarding the rate at which treatment caused which complication in which medical condition is missing from this media database. Hence, the effort is lacking any basic scientific rigor.

Now you would think that any research scientist or medical doctor quoted for a story like this would know these basic facts. Yet, the bench scientists quoted always seem to remain conveniently silent on the details, leading writers to conclusions that make no scientific sense.

The Attack on Bone Marrow Concentrate

Both this paper and a recent bench scientist blog have also mentioned Bone Marrow Concentrate (BMC) in a negative light. This is despite 3 recent RCTs showing efficacy for knee OA (52-54). I bring this up because our Canadian colleagues to the north have found out the hard way about the draconian effects of ISSCR lobbying. Before the pandemic, the group’s Canadian academics were successful in convincing the Canadian government to label BMC procedures as a drug requiring full Health Canada approval, essentially killing this procedure in that country.

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The False Dilemma

It doesn’t take a rocket scientist to see the trend here. This is called a false dilemma. You present someone who has neither the time nor knowledge to use the US National Library of Medicine to pick through thousands of studies, a false choice. The therapy is either FDA approved (which is good) or it’s not (which is bad). That simplistic narrative sounds reasonable, that is until you actually have expertise in this area of medicine. In that case, you realize that the FDA has decided that the orthopedic use of both PRP and Bone Marrow Concentrate are low-risk procedures that they have chosen not to regulate, instead leaving that regulation to the state medical boards. In addition, you also realize that the research supporting these therapies is now greater than on the surgical procedures they often replace. Hence, to the expert, these therapies are very reasonable to offer patients.

The Field Needs to Pay Attention

Interestingly enough, as I have brought up before, both orthopedic PRP and BMC procedures are being performed every day at major universities like Harvard, Cornell, Stanford, Emory, Mayo, Baylor, etc… Yet somehow these actual experts in this field are almost never quoted in these one-sided news stories. While these stories may seem like a nuisance to physicians using these technologies to help patients avoid surgery, as our Canadian colleagues found out the hard way, regulators tend to be reactive to what’s in the media. Hence, leaving these media pieces unchallenged is not a good idea.

Why This Will Keep Happening

The bench scientists and universities that have licensed stem cell technology to private companies have a problem. In the orthopedics space, the patents they have licensed are for therapies that don’t occur in nature. That also means that they require full FDA clinical trials and approval before use. Those costs are HUGE. Hence, the end price of these stem cell drugs will be high. However, if these therapies can’t beat much cheaper PRP or BMC in the marketplace, you can expect these licensed technologies to get little traction in the market, generating little for the professors and universities holding royalty agreements. Hence, it’s far easier to take out the competition now via these media pieces than to explain to United Healthcare why their $10,000 a vial drug needs to be reimbursed when it can’t beat much cheaper PRP.

The upshot? The false dilemma in the field of orthobiologics, pushed by bench scientists, isn’t going away anytime soon. In addition, in this rebuttal, it takes more than 50 scientific references just to show that it’s a bogus argument. Hence, as a field, we need to pay attention and make sure that these one-sided media stories and blogs without a solid scientific foundation are countered with the actual published science.

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References:

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(35) Pasin T, Ataoğlu S, Pasin Ö, Ankarali H. Comparison of the Effectiveness of Platelet-Rich Plasma, Corticosteroid, and Physical Therapy in Subacromial Impingement Syndrome. Arch Rheumatol. 2019 Mar 28;34(3):308-316. doi: 10.5606/ArchRheumatol.2019.7225. PMID: 31598597; PMCID: PMC6768781.

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(48) Kesikburun S, Tan AK, Yilmaz B, Yaşar E, Yazicioğlu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26. PMID: 23893418.

(49) Kesikburun S, Tan AK, Yilmaz B, Yaşar E, Yazicioğlu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26. PMID: 23893418.

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(53) Hernigou P, Bouthors C, Bastard C, Flouzat Lachaniette CH, Rouard H, Dubory A. Subchondral bone or intra-articular injection of bone marrow concentrate mesenchymal stem cells in bilateral knee osteoarthritis: what better postpone knee arthroplasty at fifteen years? A randomized study. Int Orthop. 2020 Jul 2. doi: 10.1007/s00264-020-04687-7. Epub ahead of print. PMID: 32617651.

(54) Hernigou P, Delambre J, Quiennec S, Poignard A. Human bone marrow mesenchymal stem cell injection in subchondral lesions of knee osteoarthritis: a prospective randomized study versus contralateral arthroplasty at a mean fifteen year follow-up. Int Orthop. 2020 Apr 23. doi: 10.1007/s00264-020-04571-4. Epub ahead of print. PMID: 32322943.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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