The Death of Fillers and Neuromodulators?

“Fillers and neurotoxins are dead, they remain dead and we have killed them, how shall we comfort ourselves the murderer of all murderers. What was mightiest and holiest that the aesthetic world has ever owned has bled to death under our needles. Who will wipe this blood off of us what water is there to clean ourselves?”

Nietzsche infamously warned in 1882 that “God is dead.” And while he wasn't referring to the death of religion or God necessarily, the philosopher's message was one of caution. Western Europe in an enlightened fervor had replaced religion and rationalism with a powering empiricism, wiping away the thoughts and faith of that which cannot be seen. He felt that when the masses realize that there was no longer a religiously inspired moral compass to set direction, then chaos and nihilism would ensue. His message, perhaps a bit alarming, was received by a pioneering few who felt enough wind at their backs to stand up to a rigid establishment. These courageous thought leaders then led us all to recognize, that which is not seen or proven can…still exist.

Many of the greatest achievements in science and medicine come not solely from the 2- dimensional minds of empiricist but from ability to shape, quantify and codify the output from the creative minds of rationalist thinkers. The abstract romantics designed thought experiments to unveil the illusive mechanics of nature. Galileo imagined that two objects of different weights tied to each other would hit the ground simultaneously. This greatly influenced Newton's law of motion. Newton himself described the universal law of gravity by imagining a cannon ball circling the earth if fired from a mountain top at the appropriate speed. Freud described a subconscious that influenced behaviors and could be mined for pathology.  Semmelweis recognized a deadly infectious and communicable agent 15 year before Pasteur confirmed a germ theory. And the most famous of all thought experimenters, Einstein jumped on a light beam and descended in an elevator in order to translate a theory of relativity that deviated so far from the established thinking that it was dubbed as Semitic pseudo- science. It was not until 1919 that Sir Arthur Eddington proved during a solar eclipse that light does indeed bend around a sun and confirmed Einstein's relativity. The list of scientific milestones that were originally conceived in the minds of imaginative thinkers goes on and on, many of which had no references to cite. And likely in today's academic environment, Einstein and his crew of creative misanthropes with no professors to acknowledge and no alms to nourish impact factors, would have a great schism to cross in order to get published in a prestigious journals. Their findings today would likely be introduced via trade and open access journals or the vocal social media outlets.

Todays' increasingly dogmatic medical environment feels at times like it is beholden to a cabal promoting agendas. And their words are preached in a version of scripture presented to the commoner as Evidence Based Medicine (EBM). While conceived with greatest of intentions, EBM has attracted a nearly religious following, highly vulnerable to hijacking by a well-meaning clergy of academics, authoritative bureaucrats, and profit-motivated insiders with an intent to direct the training and delivery of medicine. However, hidden from those in the pews, the canonized sacraments of Evidence Based Medicine are based on conditions that can only be considered a loose representation of everyday clinical reality. It is ironic “…that there is currently little evidence that EBM has actually improved patient care.”^1,2 Doctors beware: the authoritative bodies that dictate and mandate the practice of medicine may use an allegorical syntax to increasingly influence and enforce how you should practice.   Large EBM studies are designed to prove efficacy for the masses as well as to consider cost. They rarely are created for the individual, nor are they sensitive and amenable to what happens in the aftermath of their implementation.² Not all populations are the same, and as any researcher can tell you, the dosing and delivery of a drug or device in a clinical study is often a departure from how it is offered and delivered in clinical practice. I can tell you first hand in clinical trials proving neurotoxin efficacy a 2/5 point scale reduction in a wrinkle score is required. And the toxin is reconstituted with normal non- preserved saline. My daily clinic patients would not tolerate this type of practice as neurotoxin mixed with non -preserved saline as opposed to preserved has a greater tendency to be painful and a 2- point reduction in a glabella or crow's feet wrinkle is more likely to lead to an unnatural “frozen” appearance. Clearly a deviation from the goals of the patient. Similarly, in a clinical study proving efficacy of a filler a one- point reduction in the depth of a naso-labial fold (NLF) is required. However, I am limited to using a needle and instructed to place the filler into the dermis. For the collagen stimulating filler, Poly-L-lactic acid (Scultptra), I am asked to reconstitute the product with 5cc of water. None of these filler practices are standard, and all of these methods are more likely to lead to unnatural results. And concerningly, using needles in the NLF if inadvertently placed too deep have a potential for devastating complications. Yet once the product is approved via well done EBM studies, we are encouraged to follow these protocols in practice. The majority of teaching to the novices is based on approved label methods.  Last week I was at a major conference where I heard a young academic from a major institution report two cases of vascular complications following filler injection into a known risky zone using a needle. I was astonished. Where and how to inject filler safely with a large bore cannula is well known and defined by those with extensive experience in clinical practice. And while the safer more reliable methods for using fillers and neurotoxins are being taught under the umbrellas of CME, it is much less heralded and often drowned out by the tidal wave of sponsored training session using published EBM studies. Of course, it is understandable, many have a vested interest in training more providers and they are required to only teach that which has been studied and proven safe. It makes sense that regulating bodies and academics tasked with protecting the public want to make sure the on- label methods only are being promoted. But while such dogmas help to protect from the rogue treatment or treater at the same time they harness the visionary and creative adapters in technique and safety. And while the degrees of improvement in safety that are identified and put into practice by the progressive clinicians is usually small the much larger impact on clinical practice is the leap of improvement in cosmetic outcomes that comes from “off label” non- EBM methods instituted.   The problem we face is that if newer advancements are not effectively transmitted to the masses of trained providers then the vast majority of providers will use the allegedly less safer method and less natural outcome producing techniques defined in the EBM trials. Those providers offering safer and better outcomes will be marginalized. A misled public will unduly develop a negative impression and fear of a product and/or treatment. And a promising industry is at risk for being commoditized and defeated perhaps beyond repair.

Today, there is a lot more opportunities for those who read and write the language of EBM to reach the masses through sponsored workshops, established media outlets and traditional peer review print. But if our universities, journals and societies want to remain relevant and really protect, and provide the best and most current treatments to the public then the established channels of yesteryear are going to have to bend to the rapid flow of non- EBM information from the selective disruptors. A younger generation much savvier in disseminating information to the masses is coming of age. They will be more apt to disregard journals, meetings and societies and go straight to the consumer if not given a seat at the table.

A movement has already begun. Look no further than the multiplying open access journals as well as vocal social media influencers forming a swelling and motivated crowd outside the gates. No court is immune to a spirited majority. It is rather obvious today the most recognized physicians in any specialty are not those who have published 100 scientific papers but rather the ones with a 100K Instagram followers. Let this be a wake- up call to those who control traditional routes of information. It is time we manage the reigns of EBM define, focus and limit its influence. The data should be cautiously interpreted through a lens of reason and a commentary of practicality. And let's welcome back to our meetings, journal, and societies the free thinkers the internet darlings and the progressives who have been kicked to curb by EBM. We don't have to adopt their ways but we certainly can provide an honest and respected forum to hear their progressive thoughts without requiring them to hire a Ph.D. in mathematics to validate their message.

No field of medicine needs its creatives more so than that of aesthetics. Let's not lose them.

—Steve Dayan, MD
Co-Chief Medical Editor

1. Ioannidis JPA. Evidence-based medicine has been hijacked: a report to David Sackett. J Clin Epidemiol 2016;73:82e6

2. Fava GA, Guidi J, Rafanelli C, Sonino N. The clinical inadequacy of evidence-based medicine and the need for a conceptual framework based on clinical judgment. Psychother Psychosom 15;84: 1e3.