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Where Will Hubris Lead Us In 2019?

From the standpoint of a patient, I have been observing from the sidelines an intense and baffling hubris that has arisen among too many clinicians, scientists, and other innovators in the stem cell world. It seems to stem from an over-confidence in one’s own subject matter authority, despite a clear bias evident to those outside. Often also, the individuals prone to hubris seem to have in common a clear grasp of not knowing what they don't really know. When acted upon, their discourse can lead to unnecessary and unhealthy competition, even aggression when interacting with the various stakeholders and new explorers within the regenerative medicine space -- it's an always-unnecessary, heightened sense of competition, the outcome of which, I fear, is needless delay, confusion, rancor, and complication which the patient must try to navigate while making decisions -- without benefit of a reliable, balanced presentation of objective, fair, and complete data from a multidisciplinary , as well as specialist-informed, view of an issue. This construct has been the de facto gold standard of clinical practice for decades.

The problem is, frankly, that hubris feels good. It's the easy way to gain a psychological advantage. But the trouble is, it is also disingenuous at its core, and often shrouded in wink-and-nod cronyism, as well as steeped in self interest that is augmented in the patient's eye, but narrowing the true promise of regenerative medicine, especially for the patients who so desperately need the science to advance from within talented imaginations... as many as science can muster.

Hubris is also a "finite game", and a rather short-term one at that. It can be weaponized and used strategically to inflict real damage to others in order to gain short-term profit or temporary recognition. It both deters critical challenge (especially in the blog format), and diffuses energy, steering resources away from supplying relief to patients from their suffering and pain, and defers much-needed opportunity for healing. I'm sick of it. Really. To my stomach.

It's time for those doctors and scientists out there (who tend to be a vocal minority with big megaphones) to remember the benefit of an ethos that embraces a multidisciplinary team approach to providing integrated care to patients, and strive to embrace anew a commitment mutual respect for other professionals carrying the expertise to solve patients' problems. We do better work when we work together.

Challenging ideas, ethics, behaviors that we believe harm patients. Isn't that paramount? Well, yes, it is. But that's not what we're seeing in the discourse out there. We're seeing more dogma, culture, and resistance to change, all which are not good science, and fueled by a natural need to remain relevant. So, in a period where innovation challenges our day-to-day truth at lightening speed, we can sometimes resort to thumping our sacred texts to retain authority.

That is precisely why hubris is so harmful for patients.

In my opinion, there is a fatal flaw in believing our pet technologies or advances are the best thing since peanut butter – misinformation and bias gets all the attention. It’s juicy and provocative. It gets online likes, views, hits, those little red "dopamine dots" that light up our screens as well as our eyes. It causes our better angels to cringe as we aggrandize our own innovations by tearing down everyone else’s.

Purveyors of hubris often shrink into a shroud of passive aggressiveness after successfully provoking conflict, then backing off to watch the fight. Hubris in professional pursuits first takes the form of debate, and then turns personal. In academia, for instance, it is ideas that can become currency. In medicine, it might be authority and recognition. In business, perhaps wealth and survival. In industry, it's cornering a market against competition.

Hubris in industry seems to be the kind we're seeing quite often right now in this competitive new marketplace for regenerative medicine. The desire to corner a market, which could happen for awhile, but usually over time, this tactic will ironically drive that market right back into its own corner with few options for sustainability.

Patients lose out once again.

Even patients know that not all technologies are created equal, but on the other hand, it’s far too early in the regenerative medicine space to declare any real market superiority, and the sheer pace of innovation globally will force itself into any vacuum created by our arguing, outpacing our ability to succeed while we fight about who is right. In the clinical space for cellular medicine as it stands today, all you have to do to lose is to factor in regulators already spooked by safety questions, which patients understand more clearly than most people give them credit for. You'll then discover a tragic recipe for slowdown or shutdown of whole sectors of technology we all know are helping people.

So what is the answer, or at least a partial remedy to the damaging effects of hubris on patients, and the public? Consider this. There is too little credence being given to specialty knowledge. Special expertise is like a glue spread between specialist scientists and clinician scientists, whether they are working with adipose, bone marrow, perinatal products, or other MSC sources we haven't even yet discovered and isolated. We need to start honoring specialty knowledge again.

Failure or refusal to give value to specialized expertise relative to our own knowledge and training does nothing more than fan flames and reinforce hubris. Should we continue to allow such distraction? Debate is essential to honing our knowledge, but lack of due regard to colleagues from within other disciplines because your collective isn't culturally ready to accept its legitimacy, is toxic.

Isn’t it time to learn how to play nice in the sandbox of opportunity that awaits our participation? After all, it’s a huge sandbox, and deep, with plenty of room for all serious players to learn, experiment, grow, and ultimately prosper. It's also much too broad right now to dominate. Only temporary "wins" are possible. Innovation is moving far too quickly worldwide for individuals to rationally believe their technology has a shelf life comparable to what they are accustomed to seeing in the medicine that has been practiced over the past several decades. What that also means is that we must consider that angst over any given technology will fade in favor of a new shiny thing, which is even more controversial, at least for awhile.

And believe me when I say that patients will need the stability that experts in a given field will provide. They will clean up the educational mess left by the next shiny, flavor-of-the-month controversy as it abandons a technology the patient needs.

Shiny Thing 1: bone marrow-derived MSC therapeutics are the granddaddy of the industry to date. CBER is on record as being generally very comfortable with their appropriate use, within limits. The characteristics and mechanisms of action are well-known and established. Even though there is not much debate around their use with the exception that they are not the first choice for all indications, bone marrow used to be a shiny thing controversy.

Shiny Thing 2: not long ago, the scary, adipose-based MSC therapeutics were all the rage for critic targeting. Have you noticed that the frenzy has settled a bit? I suggest this has happened because there is a growing realization that adipose-derived MSCs have a potent impact that cannot be ignored.

Funny thing is, adipose MSC scientists at major research institutions have been working for over a decade on fat technologies, so as far as I’m concerned, should have always had the mic when the conversation turned to fat. But because that didn't happen, practices got shoddy, and unsafe, and now limited, even restricted. If experts had been allowed to educate, things could have been different.

Shiny Thing 3 - the latest shiny thing target: perinatal birth products -- now an in vogue opportunity for healing that is now being unfairly generalized as hocus-pocus by non-experts. Although causing less of a hubris rumble than fat did, the negative public education being generated by the collective outcry against bad practice, unethical behavior, and deceptive claims by irresponsible practitioners and distributors hocking umbilical cord blood that is not only poorly processed, but outright dangerous is being damaged more by the commentary driven by hubris than that driven by the facts.

What is maddening right now in this space is that in some cases, practitioners outside the perinatal community of experts carry the megaphones, dominating a chorus of those calling for accountability, but offering little in the way of information that supports any of the benefits of that same therapeutic when it is properly handled and represented. This confuses not just patients, but other physicians and researchers as well, and is a practice discouraged by the International Society for Stem Cell Research.

I’m not alone in my position. I recently reached out on this subject to Cade Hildreth, President of BioInformant, Inc., who told me, “Perinatal birth products represent one of the most promising areas of regenerative medicine. The cell populations contained within the newborn umbilical cord blood and tissue, amniotic fluid and tissue, and placental blood and tissue, will fundamentally impact the field of regenerative medicine over the next decade. It is not a coincidence that of the 16 cell and gene therapy products approved to date by the U.S. FDA, half of them (eight) are umbilical cord blood derivatives.”

Ian White, Chief Scientific Officer of IMAC Regeneration Centers, expressed to me his concern and frustration recently about the problem he sees of incomplete information to patients regarding the benefits of perinatal birth products, and the impressions being formed by misinformation dominating the current narrative surrounding them. commented during our conversation, telling me:

“The current rate of growth within the field of regenerative medicine is unprecedented. This should be a good thing. However, the challenge we’re facing is that this growth, in many ways, is unconstrained, and even malignant, as we have seen in some of the more dangerous cases we hear about from time to time in the news. Maintaining a proper course of clarity for patients requires a very strong commitment from a given sector to keep them properly informed by experts with a unified message. Otherwise, less expert voices can obscure valid efforts of those with specialized training and experience, keeping them from collectively steering the future growth of this field in the right direction. Right now, this is especially vital in my field of perinatal therapeutics.”

I make no claim of expertise in the specifics of which therapeutic, derived from which source, is optimal for which indication. But I do know that they all have their place in helping the plight of patients, and I do know that one day, we all will be patients needing the best products with the best minds behind them, to help us.

Let’s give experts in their respective fields the mic. Most often they’ll be the ones we depend upon in the end. In the latest controversy around perinatal products, I’m suggesting that it is the subject matter scientists who have known for over a decade the promise of properly processed perinatal tissues and cells who are the ones we should listen to.

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