West Texas Doctor Bartlett: Is He on to a ‘Silver Bullet’ with Use of Off-Label Inhaled Steroid as COVID-19 Treatment?

West Texas Doctor Flirts with Trouble Making Claims of ‘Silver Bullet’ Off-Label Use of Inhaled Steroid as COVID-19 Treatment

A local West Texas doctor believes he has come up with an approach to effectively treat COVID-19. Dr. Richard Bartlett has practiced medicine in Texas for 28 years, and according to his claims, he advised ex-Governor Rick Perry’s for several years. Dr. Bartlett does a regular weekly radio update on COVID-19 in West Texas. The doctor found himself in hot water for declaring that the treatment of inhaled steroid (ICS) Budesonide is a ‘silver bullet’ for treating COVID-19. TrialSite News responds with a few points here: First, the doctor knows all too well the politics and regulatory considerations of the U.S. healthcare system to make such claims. Second, he is not alone in considering this approach, as world-renowned universities such as England’s Oxford University are also studying this type of regimen. Third, as Dr. Bartlett is part of a movement of community doctors demonstrating practical potential approaches to reducing the severity of the pandemic, any real-world data should be embraced rather than ridiculed, and if promising, rapidly incorporated into research. Fourth, that certain societal forces will pounce on one mistake in messaging in an attempt to tarnish an entire real-world approach with promise, evidences just how politicalized health and medicine has become in the age of COVID-19. We advocate for a pragmatic approach to exploring economical, safe and available approaches, validated by a combination of clinical trials and careful analysis of off-label, real-world use alone and in combination with advanced biotech initiatives, such as the recent REGN-COV2 announcement. It will take a combination of flexible, dynamically-tailored solutions that may differ based on region, economy and society.

The Doctor

Dr. Richard Bartlett has practiced medicine in Dallas and in West Texas for over two decades. With past political aspirations, he had some past dealings with controversy having been investigated by the State Board for allegations of ordering unnecessary tests and procedures for several patients. Dr. Bartlett purportedly was selected some years ago by Governor Rick Perry to join a health disparities task force with a goal of exploring how to make health care available to all Texans. He apparently serves on health missions and appears to be a dedicated doctor to the cause of health care for all. He currently runs a weekly radio show with updates on COVID-19 in West Texas.

Mistakes Happen

It is a mistake to make a medical claim in the U.S. until the evidence accumulates to a point of clarity. However, that doesn’t mean that Dr. Bartlett’s approach isn’t potentially a possibility, and certainly it should be further explored if there is truth to it. Just because a mistake was made in how something is described doesn’t mean one should get publicly lambasted from all sides. 

In a recent interview, Dr. Bartlett suggests that low COVID-19 death rates in nations such as Taiwan, Iceland, and Singapore are due in part to the approach he employs for his practice. For example, in Taiwan, where there are 24 million people, only seven have died. That these nations have lower COVID-19 death rates is accurate according to the available online tracking systems. He includes Japan as another example, with over 120 million people, less than 1,000 have died. How could that be? Why do countries such as these have such low death rates? Bartlett suggests social distancing doesn’t work as well in Taiwan and Japan since these countries are incredibly densely populated. TrialSite News embarked on a preliminary review of his claims that these countries use his approach, and the evidence is miniscule. There is a dearth of literature on what he claims to be common place, which leads one to believe that the doctor may get ahead of himself and make exaggerations. But there are some interesting data points. 

Nascent Corticosteroid Evidence?

Dr. Larry Nelson, Chief Medical Officer of Midland Memorial Hospital, responded to Bartlett countering that there is no evidence for his claim. Dr. Nelson did, however, acknowledge the recent results from the RECOVERY trial where some steroids, such as dexamethasone, could be effective in helping with severe COVID-19 cases when administered orally or intravenously. But Wilson cautioned giving patients that are not that ill steroids could do more harm than good, as they have known side effects.

In a similar situation to the ivermectin scenario, while physicians apply experiments in the field in off-label use cases and encounter observed success, the fact that they are not done in controlled studies leads the medical establishment to reject them. This kind of challenge raises a difficult “chicken or the egg” scenario, as there is often not sufficient capital, resources nor human capital (e.g. talent) nor time to conduct such formal, controlled studies in the middle of a pandemic.

However, some research looks into this question. A group from England and Australia studied this treatment and suggests “there is some evidence to suggest that taking ICS (inhaled corticosteroids) may be beneficial in dealing with virus infections, specifically those due to coronavirus.” For example, they note that “Pre-treatment of human respiratory epithelial cells in vitro with budesonide, in combination with glycopyrronium and formoterol, has inhibitory actions on coronavirus HCoV-229 E replication and cytokine production.”

This group also points out that although not peer reviewed, ciclesonide blocks SARS-CoV-2 ribonucleic acid replication in vitro, and inhibits SARS-CoV-2 cytopathic activity, leading to speculation that this could reduce the risk of the development of COVID-19 or its severity. 

Dr. Bartlett suggested Japan uses ICS extensively, however according to the Halpin, et al the evidence for ICS treatment involves a “very low quality case series report” involving three patients with COVID-19 requiring oxygen but not ventilation post-ICS involving ciclesonide. 

In another report in the Journal of Infection and Chemotherapy, the authors notes three cases of patients with COVID-19 pneumonia successfully treated with ICS that persists in the lung. The authors acknowledge that greater study is required. Then there was the RECOVERY trial results out of the University of Oxford identifying the use of dexamethasone, a corticosteroid, as a way to reduce deaths associated with COVID-19 opens a pathway for pursuit involving a corticosteroid. In this study, the drug was administered orally or intravenously.

Patients Come to Doctor’s Defense 

Recently the doctor faced attacks from critics because again he made the mistake of declaring that the ICS approach was a “silver bullet” for the treatment for COVID-19. A local hospital, Midland Memorial Hospital, certainly disagreed, correctly stating “there is no such thing as a ‘silver bullet’ treatment for COVID-19.” However, as reported in News West 9, the doctor’s patients came to his defense, declaring the physician saved lives. According to this local news, the doctor has treated “well over a dozen patients,” and the success rate is purported to be 100%.

The STOIC Clinical Trial

As it turns out, TrialSite News reported on a significant clinical trial led by Queensland University of Technology and Oxford University, centering on assessing the effectiveness of inhalers (you inhale with a nebulizer and inhaler) as possible treatment for COVID-19. Called the STOIC trial, the patients are recruited at Churchill Hospital in Oxford, England. The investigators will evaluate the efficacy of inhaled corticosteroid therapy compared to the standard of care in participants in early COVID-19 illness. Of course, Budesonide is just another corticosteroid, so the doctor is not alone in considering this approach.

Conclusion 

Dr. Richard Bartlett is outspoken. His claim about an approach to treating COVID-19 that can’t be proven with just a couple dozen treated is a bit hasty. He doesn’t have enough data yet to declare inhalable corticosteroids a “silver bullet.” That was an unfortunate slip. But the messenger may still be on to something noteworthy. After all, it turns out there is some research ongoing into this general class of treatment, evidenced most recently by the results of the RECVOERY trial out of the University of Oxford (albeit a different type of corticosteroid–one taken orally and intravenously).  

People want to have a savior, a knight in shining armor that rides in to save the day, and such a hero unfortunately hasn’t been able to take out the enemy of COVID-19. Rather, the scientific community should continue not only with vaccines and advanced biological approaches to killing off COVID-19 but also pay attention to doctors in the field, from West Texas and South Florida to France and Taiwan, to Peru and Bangladesh and consider that real world activities that may in some cases lead to some promising pathways.