“Primum non nocere”

Drs. Donald J. Rinchuse, Dara L. Rinchuse, and Mr. Donald N. Rinchuse discuss the safety and health of patients, orthodontists, and staff during the COVID-19 crisis

Abstract

This article explores the impact of the COVID-19 pandemic on orthodontic practice. It reports on the current public health and evidence-based medical and scientific news related to the novel coronavirus.  Addressed in this paper are the considerations that orthodontists will need to make once the country “reopens.” This paper alerts practitioners to orthodontic treatments and behaviors that are good and beneficial versus those that are harmful and jeopardize personal safety.

Introduction

The COVID-19 pandemic has certainly affected the lives of the world. “Stay at home,” “shelter in place,” “safe at home,” ”stop the spread,” “flatten the curve,” “safe distancing,” “wash your hands” — all are cautionary statements we have recently heard. Of course, there is the sobering reality of the many lives that have been lost due to COVID-19. Scientists around the world are working on diagnostic tests, treatments, and a vaccine. The mantra is, Test, trace, isolate, treat, and pray for a vaccine. Unfortunately, it has been estimated that a vaccine will not be produced for 12 to 18 months.

Renowned physician-scientists on the national news such as Drs. Anthony Fauci, Deborah Birx, and Sanjay Gupta have cautioned on using drugs and treatments before the science is proven effective. The efficacy and safety of the drugs and/or treatments have to be evaluated. Even though there was an abundance of the COVID-19 diagnostic tests approved by the FDA, many have been found to be inaccurate with poor sensitivity and specificity.

There are anecdotal reports of the effectiveness of several of the COVID-19 treatments such as the anti-malaria drug hydroxychloroquine (Plaquenil), which is presently used to treat autoimmune diseases such as lupus and rheumatoid arthritis, and azithromycin (Z-Pak). However, studies are demonstrating no benefit and serious side effects.  Recall that Tom Hanks and his wife, Rita Wilson, were in Australia working on a movie when both contracted COVID-19. (It may also be that they brought the virus to Australia from California.) Both recovered, but Rita Wilson later lamented that the chloroquine drug regimen she was given had many profound adverse side effects. A recent French study (i.e., Dr. Didier Raoult, Marseille, France) found that the chloroquine regimen did not work and caused severe side effects.  In addition, there was an RCT study in Brazil also testing the efficacy of the chloroquine protocol, which had to be halted because those in the high-dose treatment “arm” of the study (same doses of chloroquine as given in China) had fatal heart complications with 11 deaths.¹ In another recent hydroxychloroquine study involving patients in U.S. Veterans Health Administration Medical Centers, the drug was shown to not be an effective treatment against COVID-19 and caused twice as many deaths as those who were not given the drug.  Medical treatments must be effective, efficient, and most importantly, safe.

There is also the recent proposal for a transition drug like the tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), first used in the United States in 1921. In addition, there has been a clinical trial to test the efficacy of the antiviral Ebola drug, remdesivir. Furthermore, proposals for the testing of convalescent plasma from recovered COVID-19 patients are underway. Parenthetically, Michigan has launched the largest antibody study. As of this writing in April, as many as 40 clinical trials and more coming each day are focused on combatting COVID-19.

 “Do no harm”

Primum non nocere is the Latin for “First, do no harm.” This maxim has sometimes been recorded as “Primum nil nocere.”  The origin of this adage is not certain, but most scholars trace it back to the “father of western medicine” — the 400 B.C. Greek physician, Hippocrates. The Hippocratic Oath includes the promise “to abstain from doing harm.” Nonmaleficence (“doing no harm”) is perhaps the most important precept of bioethics. This moral injunction is included in every medical/dental professional code.

A more expanded and encompassing aphorism of “do no harm” is when confronted with a medical/health problem, it may be better not to do something, or even do nothing, rather than to risk causing more harm than good. Medical/dental treatments should be safe. In this light, healthcare providers are cautioned against the use of an intervention that carries obvious risk(s) of harm when there is uncertain possibilities of benefit.  Importantly, the first phase of all medical clinical trials is to evaluate the safety of a drug, product, and/or treatment.

Nonmaleficence is often contrasted with the adjunctive corollary beneficence, which means to do “good.” Healthcare providers are called to do “good” and not harm. “Good” in the healthcare context could have many meanings. Obviously, treatments should have a benefit and be based on the best available science and evidence. Treatments should not be based on therapies that are fostered by personal opinions, conjectures, and anecdotes.

This brings us to the question, Is it irresponsible to use an experimental drug or treatment that so far has no real proven benefit and shows little promise, i.e., tested in clinical trials? And is this more of a concern in nonemergency situations?  However, in life-threatening situations, could the argument be made that, when all known and standard treatments have not worked, does it make sense to try an untested and experimental drug and/or treatment? Does this have any comparison to enrolling terminally ill cancer patients in experimental clinical trials when all else has failed? This of course is dependent on the therapy being safe, i.e., with limited side effects. The argument is then “nothing tried, nothing gained, and nothing lost.” The families of those who have lost loved ones trying an experimental drug or treatment would probably have been grateful for the opportunity to have at least tried something — no lingering regrets in that they saw to it that all options were exhausted. But if experimental drugs being used to treat COVID-19 are also ones that are presently used to treat other illness — chloroquine to treat lupus and rheumatoid arthritis — then you could deplete the supply of that drug needed so badly by others. Further, by using one experimental drug and treatment over another one (because of bias toward that drug), you have then eliminated the use of other experimental drugs and treatments that may possibly have more benefit and actually work. Furthermore, there is the issue of giving false hope.

In addition, if states “reopen” too soon, this could lead to a “rebound” increase in the virus. There could potentially be more virus in our communities at the “reopening” than there were at, and during most of, the closing. The decision on when to reopen the country in some cases has pit public health advocates against those who are concerned about economic health, and certainly there is no good answer. This is a further issue of benefit versus risk and beneficence versus nonmaleficence.

Nonmaleficence and beneficence in orthodontics

Does the debate on the treatments for the COVID-19 pandemic prompt orthodontists to consider the safety and efficacy of their diagnostics and treatments? Because orthodontics is elective, and in light of what we have learned so far from the COVID-19 pandemic, orthodontists must take an ardent look at what treatments and procedures are, and can be, harmful. Much, if not all, of the potentially harmful side effects of orthodontic treatment are enumerated in the American Association of Orthodontists (AAO) Informed Consent Documents. Orthodontics can cause or contribute to root resorption, decalcification, decay, and periodontal disease.  Although not causative, orthodontics can be associated with, and contribute to, temporomandibular disorders.^2,3 Certainly, bonded lingual retainers can cause harm when they become detached and/or remain in place for extended periods and become a hygiene/periodontal concern, mostly due to neglected follow-up appointments.

Further, when a patient is at an increased risk for harm, due to a procedure or patient comorbidity, certain mitigation procedures can be performed. For instance, for patients at risk for root resorption, lengthening out appointments, using lighter forces, more frequent imaging, erroring toward non-extraction therapies, and so forth, can be implemented. Nonetheless, some patients should not be treated; the risks outweigh the benefits. Orthodontists must continually weigh the benefits versus the risks of treatments for all patients, and for all situations.

The preceding examples are some of the physical harms that are possible consequences of orthodontics. There are also ergonomic and economic (time and money) harmful effects from improper diagnoses, treatments, and treatment mechanics. For instance, cases that are strictly “ortho-gnathic surgery-orthodontic” that are treated solely orthodontically can often have devastating consequences; treatment results can be very poor, and orthognathic surgery may not be an option later on. It is important for orthodontists to pay attention to the evidence-based literature that is based on RCT, meta-analyses, and systematic reviews. Not doing so can cause harm to patients from the viewpoint of efficacy, efficiency (increased burden for orthodontists and patients), and costs. Certain Phase I treatments (e.g., Class II’s with 7 mm-plus overjets) that were performed years ago are not currently supported by the evidence.  That is, the same or similar results can be attained with one comprehensive phase of treatment versus two separate phases of treatment. The point of stressing evidence-based treatments was well articulated by the health scientists in regard to proposed treatments for COVID-19.

The foregoing addresses some of the potential harms of orthodontic treatment.  But what about the harm that we, our staff, and family could face? The safety and health of all we come in contact with should be our highest priority. How do orthodontists lessen their exposure and those of others? Much of what orthodontists will need to do upon reopening will be decided by the federal and state governments, CDC, ADA, and AAO. These dictates will come as requirements and/or guidelines. We have all become familiar with the details of these obligations.

Interestingly, the American Dental Association (ADA) has just called for the U.S. Health and Human Services (HHS) to furnish coronavirus testing kits to dentists so they can swab patients prior to treatment once the economy reopens. As we are well aware, there are aerosol clouds (potentially containing the virus) produced from dental high-speed (possibly low-speed) drills.

Addressing the COVID-19 pandemic will be more of a marathon than a sprint. Importantly, orthodontists must seriously contemplate the real possibility of facing a “rebound” and a second wave of COVID-19. Parenthetically, there were three waves during the 1918 Spanish Flu. Without a sustainable reopening, there could be a “rebound.” This would lead to an increased numbers of cases due to states reopening prematurely and citizens ignoring the strict guidelines imposed during the initial COVID-19 wave. In addition, the CDC has issued a warning that there could be a second wave of the COVID-19 virus occurring this coming fall and winter. This wave could be larger than the first. And there could be the simultaneous presences of both the COVID-19 virus and the regular flu virus(es). Either of these two episodes could lead to another shutdown of the country. The lessons learned from other infected countries should be our guide. This all leads to the question, Are orthodontists thinking and planning for the possibility of a “rebound,” second wave, and another shutdown?

On the reopening of dental and orthodontic services by the individual states, will the states only allow a “soft opening?” — that is, patient appointments limited in number and social distancing observed as much as possible. Or will it be up to each practice owner to make his/her own decision.  In the infection control world, “herd Immunity” protects a population from contagious diseases. However, as the world works its way back from the COVID-19 pandemic and reopens, there will still be infected people out there. As more businesses start to open their doors, it may not be the time in orthodontics to do “herd scheduling” — that is, return to a full schedule of patients or even schedule more patients than before the pandemic.  Even with the best infection control procedures, just having a lot of patients scheduled in our offices at one time would increase the risk of spreading the virus. But the argument will be, “I have lost so much money during the shutdown that I have to make up for it.” As an aside, teledentistry/teleorthodontics has been important during the shutdown, and it will be equally or more important during the reopening. This is especially true for clear aligner therapies. This COVID-19 pandemic has challenged the orthodontic community to further investigate all the possible uses of teleorthodontics.

What about consults and starts? This is where the new money is made. Will orthodontists go back at the outset of the reopening doing consults and starts? This is not a moral, right or wrong decision, just a point to consider. In addition, will orthodontists be able to keep up with the escalated demand for more elevated types and quantity of personal protective equipment (PPE), and keep up with the enhanced infection control engineering protocols aimed at reducing the spread of the virus and protecting the safety of everyone? In this period of the COVID-19, the business side of orthodontics will most likely overshadow the professional side. Orthodontists may be placed in positions that require them to make difficult decisions that will be based more so on economics and finances than service to patients. Will the survival of the practice take priority over just about everything else, albeit safety? This will be a difficult situation for orthodontists who have placed an emphasis on the professional and service side of orthodontic practice. The justifiable argument for taking the side of business over profession (and it is certainly justifiable) will be, “If I lose my business, how can I possibly do the good deeds that I have always done to support the profession, the public, my church, and the needy?”

Every so often, we orthodontists need to be reminded of our duty to “do good” and “do no harm.” As the saying goes, “The darkest part of the night comes before the dawn!” In the darkness of the pandemic, let us try to open up the light of love! “Good” orthodontics is delivered in a kind, caring, and empathetic manner. Do unto others as you would have them do unto you. And better yet, do unto others as you would want them to do unto your kids and grandkids; we love our kids and grandkids more than ourselves. Give patients more than what they paid for.  When possible, orthodontists should strive to make “the orthodontic experience” the best part of a patient’s day.^4,5

Crisis situations bring out the best and the worse in people. Let this COVID-19 pandemic bring out the best in us. As we shelter in place, we will have time to contemplate the new normal in orthodontics. We have the opportunity to make our profession and ourselves better from our struggles in dealing with COVID-19. We need to once again earn the respect of the public, our staff, and patients/families. As we lie down at night, and if we dream hard enough, we may also in some small way envision the displays of gratitude relegated to the frontline COVID-19 health providers with our cities lit up in “blue lights” with signs saying, “Heroes work here!”