Protecting the Public’s Health-Except in Tennessee

State regulatory boards that regulate professionals such as doctors, nurses, psychologists, etc. are often appointed by politicians and headed by lawyers. Under this category has been most Medical Boards and their parent organization the Federation of State Medical Boards. Although they claim to be protecting the public, they seem more concerned with identifying “disruptive” physicians and blacklisting them through the National Practitioner Data Bank (1). However, in July the Federation issued a warning to physicians against propagating COVID-19 vaccine misinformation and disinformation citing a "dramatic increase" by physicians (2). The statement gave some hope that the Federation was striving to maintain some degree of professional standards by saying that spreading disinformation to the public was dangerous because physicians enjoy a high degree of public credibility.

The Tennessee Board of Medical Examiners followed the Federation’s lead by issuing a verbatim restatement warning that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license. Under repeated threats by Rep. John Ragan, R-Oak Ridge, co-chair of the State of Tennessee’s Joint Government Operations Committee, the warning was removed on December 7. 

Figure 1. Representative John Ragan.

Rep. Ragan insisted board members do not have the authority to create a new disciplinary offense without the approval of the lawmakers on his committee. He threatened to dissolve the board and appoint all new members if it did not immediately take it down and the Tennessee board succumbed to Rep. Ragan.

Across the country, state medical licensing boards are struggling to balance the politics and public interest with how to respond to scientifically baseless public statements about COVID-19 by some physicians. The Federation says the statements are increasing public confusion, political conflict, preventable illnesses and deaths (3). There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. For example, Dr. Lee Merritt, an orthopedic surgeon, from my home state of Nebraska has appeared on talk shows and in lecture halls to spread false information about COVID-19 (4).

Figure 2. Dr. Lee Merritt

Among her claims: that the SARS-CoV2 virus is a genetically engineered bioweapon (the U.S. intelligence community says it is not) and that vaccination dramatically increases the risk of death from COVID (data show the opposite). The entire pandemic, she says in public lectures, is a vast global conspiracy to exert social control. Yet, in October, she was able to renew her medical license in the state of Nebraska. Documents obtained through a public records request by NPR showed it took just a few clicks: 12 yes-or-no questions answered online allowed her to extend her license for another year.

Physician ethics have also been under assault in medical schools. Several medical schools recently founded by healthcare organizations seem overly concerned that their graduates might object to some COVID-19 statements on a scientific basis (5). Through these new medical schools, business interests hope to indoctrinate medical graduates on how to serve the public any way a healthcare administrator tells them. Even a healthcare organization as lofty as the American College of Physicians now has their ethics statement written by a lawyer (6).

These, as well as other examples, demonstrate that as we lose control of the ethics of our profession, we lose control of our profession. Assuming the physicians reading this editorial are against the dissemination of false information, what can we do? One example, came from Houston, Texas where Dr. Mary Bowden, who posted "harmful" and "dangerous misinformation" about Covid-19 and its treatments on social media, had her medical staff privileges suspended. She subsequently resigned from Houston Methodist (7).

We as physicians should work through our medical staffs over these issues. Hopefully, we will not try to repress legitimate concerns from physicians expressing objections to hospital or medical staff policies through appropriate channels. However, if the medical staff chooses to proceed over those objections, each physician can use their conscience to refuse to work with physicians disseminating misinformation. We are one medical family and what hurts one of us, hurts us all.  

Richard A. Robbins, MD                                  

Editor, SWJPCC

References

1. Robbins RA. The disruptive administrator: tread with care. Southwest J Pulm Crit Care. 2016:13(2):71-9. doi: http://dx.doi.org/10.13175/swjpcc049-16.
2. Federation of State Medical Boards. FSMB: Spreading Covid-19 Vaccine Misinformation May Put Medical License at Risk. Available at: https://www.fsmb.org/advocacy/news-releases/fsmb-spreading-covid-19-vaccine-misinformation-may-put-medical-license-at-risk/ (accessed 12/13/21).
3. Sawyer N, E Bloomgarden E, Cooper M, Nichols T, Hickie C. Opinion: State medical boards should punish doctors who spread false information about covid and vaccines. The Washington Post. September 21, 2021. Available at: https://www.washingtonpost.com/opinions/2021/09/21/state-medical-boards-should-punish-doctors-who-spread-false-information-about-covid-vaccines/ (accessed 12/13/21).
4. Brumfiel G. A doctor spread COVID misinformation and renewed her license with a mouse click. Heard on All Things Considered. November 4, 2021. Available at: https://www.npr.org/sections/health-shots/2021/11/04/1051873608/a-doctor-spread-covid-misinformation-and-renewed-her-license-with-a-mouse-click (accessed 12/13/21).
5. Shireman R. For-Profit Medical Schools, Once Banished, Are Sneaking Back. The Century Foundation. March 20, 2020. Available at: https://tcf.org/content/commentary/for-profit-medical-schools-once-banished-are-sneaking-back-onto-public-university-campuses/ (accessed 12/13/21).
6. Sulmasy LS, Bledsoe TA; ACP Ethics, Professionalism and Human Rights Committee. American College of Physicians Ethics Manual: Seventh Edition. Ann Intern Med. 2019 Jan 15;170(2_Suppl):S1-S32. [CrossRef] [PubMed]
7. Watts A, Elassar A. Texas doctor suspended for spreading 'misinformation' about Covid-19 submits resignation letter. November 16, 2021. Available at: https://www.cnn.com/2021/11/13/us/houston-doctor-suspended-covid-19/index.html (accessed 12/13/21).

Cite as: Robbins RA. Protecting the Public’s Health-Except in Tennessee. Southwest J Pulm Crit Care. 2021;23(6):162-4. doi: https://doi.org/10.13175/swjpcc067-21 PDF 

Refunds If a Drug Doesn’t Work

One aspect of the high cost of healthcare is the cost of new drugs. Cancer drugs have received much of the attention because of their extremely high price (1). For example, crizotinib, used to treat non-small cell lung cancer (NSCLC), costs $19,144 for each month's supply. Pfizer, the manufacturer of crizotinib, has just announced that they are offering a refund if its drug "doesn't work" (2). If crizotinib use is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month's supply, or a total of $57,432. Of course, the cost of care includes more than just a single drug and can be much higher and Pfizer is reimbursing only the drug cost. 

Although Pfizer claims that its pilot program is a first in the industry, there have been others that were similar (2). In 2017, Novartis offered something comparable for tisagenlecleucel (Kymriah®), the B-cell acute lymphoblastic leukemia therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, the manufacturer Novartis announced that if the drug does not work after the first month, patients pay nothing. Italy has been using this system for several years. In Italy pharmaceutical companies must refund the cost if a drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.

At first glance, Pfizer’s offer with crizotinib appears very reasonable. However, the drug is usually given for at least 3 months to judge effectiveness with only 50-60% of ALK+ patients responding (3). However, that said, there is usually a fairly dramatic response when a patient does respond. Unfortunately, most patients with ALK-positive lung cancer who respond to crizotinib undergo a relapse within a few months to years after starting therapy (3).

In our view Pfizer is practicing medicine on contingency. In an industry notorious for overpricing, Pfizer is asking permission to overcharge upfront. However, the concept that Pfizer will not make considerable profit from this scheme is naive. Furthermore, there will be some that take advantage of the program. Now with hospitals and other healthcare organizations often collecting physician professional fees, the possibility of nefarious financial arrangements likely increases.

We suspect there would be a great outcry if physicians were allowed to bill similarly. For example, a physician might charge $20,000/month to treat a patient with NSCLC. Similarly, a physician could charge $10,000 to care for a patient with an exacerbation of COPD with a similar promise that if the patient did not improve, they do not have to pay.

Schemes such as Pfizer’s are an indicator of overpricing and are nothing more than another nefarious billing practice. They will not reduce healthcare costs and are susceptible to fraud. We oppose such billing schemes as not being in our patients’ or the public’s best interests.

Richard A. Robbins MD¹ and Thomas D. Kummet MD²

¹Phoenix Pulmonary and Critical Care Research and Education Foundation

Gilbert, AZ USA

²Sequim, WA USA

References

1. Nelson R. High Cost of Cancer Drugs Does Not Reflect Clinical Benefit. Medscape. May 13, 2020. Accessed October 21, 2021. Available at: https://www.medscape.com/viewarticle/930424#vp_2.
2. Nelson R. Pfizer Offers Refund if Drug 'Doesn't Work'. Medscape. October 20, 2021. Accessed October 21, 2021. Available at: https://www.medscape.com/viewarticle/961221.
3. Awad MM, Shaw AT. ALK inhibitors in non-small cell lung cancer: crizotinib and beyond. Clin Adv Hematol Oncol. 2014;12(7):429-439. [PubMed] 

Cite as: Robbins RA, Kummet TD. Refunds If a Drug Doesn’t Work. Southwest J Pulm Crit Care. 2021;23:107-8. doi: https://doi.org/10.13175/swjpcc050-21 PDF 

Arizona Thoracic Society Supports Mandatory Vaccination of Healthcare Workers

I watched much of the past year and a half of the COVID-19 pandemic in horror listening to the TV pundits and politicians argue against wearing masks, receiving vaccinations, and in general, undermining the safety and freedoms of all Americans. Nothing is done to regulate commentator or politician disinformation under the excuse that these pundits have the right of free speech as a fundamental liberty. Fundamental liberties are freedoms the population is entitled to fully enjoy without government intrusion. Nevertheless, the proper exercise of these liberties, taken in conjunction with the need for public order, national security, the preservation of moral values, as well as respect for the rights of one’s fellowman—all of this necessarily entails that some restrictions be placed upon these liberties (1).

Only the freedom of thought, conscience and opinion are subject to no real restriction. Each and every person is free to think what he or she likes without fear of government interference so long as his or her opinions remain private. Freedom of expression is limited, most notably as it pertains to the violation of moral values and to the transmission of messages that incite hatred and violence (racism, discrimination, etc.) and protection of the greater public.

Some healthcare workers are arguing that they should not be required to take a COVID-19 vaccination because it violates their fundamental rights. They are correct, they do not have to receive the vaccination, but at the same time their employer has an obligation to protect their patients/clients and other employees. That obligation exceeds the employee’s right to vaccine refusal. In other words, those acting out by refusing vaccination should not be guaranteed employment in the interest of public safety.

Due to the recent COVID-19 surge and the availability of safe and effective vaccines, most health care organizations and societies advocate that all health care and long-term care employers require their workers to receive the COVID-19 vaccine (2). This is the logical fulfillment of the ethical commitment of all health care workers to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.

Because of highly contagious variants, including the Delta variant, and significant numbers of unvaccinated people, COVID-19 cases, hospitalizations and deaths are once again rising throughout the United States (3). Vaccination is the primary way to put the pandemic behind us and avoid the return of more stringent public health measures.

Unfortunately, many health care and long-term care personnel remain unvaccinated. As we move towards full FDA approval of the currently available vaccines, all health care workers should get vaccinated for their own health, and to protect their colleagues, families, residents of long-term care facilities and patients. This is especially necessary to protect those who are vulnerable, including unvaccinated children and the immunocompromised. Indeed, this is why many health care and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.

The American Thoracic Society and the Arizona Thoracic Society stand with the majority of other medical societies in calling for all health care and long-term care employers to require their employees to be vaccinated against COVID-19 (2). Recognizing that a small minority of workers cannot be vaccinated because of identified medical reasons and should be exempted from a mandate, should be assigned other duties as possible.

Existing COVID-19 vaccine mandates have proven effective (4,5). As the health care community leads the way in requiring vaccines for our employees, we hope all other employers across the country will follow our lead and implement effective policies to encourage vaccination. The health and safety of U.S. workers, families, communities, and the nation depends on it.

Richard A. Robbins, MD

Editor, SWJPCC

on behalf of the Arizona Thoracic Society

References

1. Humanium. Available on-line at https://www.humanium.org/en/fundamental-rights/freedom/restrictions/ (accessed 8/5/21)
2. AMA in support of COVID-19 vaccine mandates for health care workers. July 26, 2021. Available at: https://www.ama-assn.org/press-center/press-releases/ama-support-covid-19-vaccine-mandates-health-care-workers (accessed 8/5/21).
3. Centers for Disease Control and Prevention. Covid Data Tracker Weekly Review. July 16, 2021.  https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html (accessed 8/5/21).
4. Bacon J. Condition of employment: Hospitals in DC, across the nation follow Houston Methodist in requiring vaccination for workers. USA Today. Available at: https://www.usatoday.com/story/news/health/2021/06/10/dc-hospitals-others-follow-houston-methodist-requiring-vaccination/7633481002/ (accessed 8/5/21).
5. Paulin E. More Nursing Homes Are Requiring Staff COVID-19 Vaccinations. AARP. Available from: https://www.aarp.org/caregiving/health/info-2021/nursing-homes-covid-vaccine-mandate.html (accessed 8/5/21).

Cite as: Robbins RA. Arizona Thoracic Society supports mandatory vaccination of healthcare workers. Southwest J Pulm Crit Care. 2021;23(2):52-53. doi: https://doi.org/10.13175/swjpcc033-21 PDF 

Combating Morale Injury Caused by the COVID-19 Pandemic

Healthcare burnout is on the rise during the great COVID-19 pandemic. Healthcare burnout is emotional exhaustion, cynicism and depersonalization, reduced professional efficacy and personal accomplishment caused by work-related stress. Numerous factors cause healthcare burnout: long work hours, lack of respect, difficult patients, feeling of helplessness, lack of healthcare worker safety and leadership seemingly disconnected from the universal goal of all healthcare workers—saving people’s lives. Morale injury occurs when hands are tied from giving each and every patient the very best care, he/she deserves. Healthcare workers experience disappointment from doing a great job when saving lives. Hearing negative feedback about inconsequential small details and lack of praise for their great deeds can understandably lead to depression, anxiety and fear about the future. In order to combat negative feelings built up over time, it is important to fight back with positive feelings. This requires active positive thinking and not negative thoughts that can consume you. Throughout the day and night all kinds of thoughts flow through our mind. This cannot be controlled but you can counter negative thoughts by thinking of positive thoughts. There are things to be grateful for everyday in life: 1) life itself; 2) family; 3) purpose; 4) belonging to something greater than yourself; 5) the weather; and 6) all of the boundless opportunities that lay ahead. According to Gautama Buddha (1),

“to enjoy good health, to bring true happiness to one’s family, to bring peace to all, one must first discipline and control one’s own mind. If a man can control his mind, he can find the way to Enlightenment, and all wisdom and virtue will naturally come to him”.

Healthcare workers expend so much of their time and energy helping others, they themselves can end up in a void. Therefore, it is important that healthcare workers set aside a time for rejuvenation. (I personally find exercise as a great way to recover and let my mind clear after a long day in the hospital). Anything that gives you joy will suffice such as listening to music, singing, reading, laughing, playing with your children or having a funny conversation with your friends and family. Even something as simple as smiling at a stranger walking by and saying good morning will not only make you feel better, but it will also make the other person feel better. I say hello to everyone I pass in the hospital hallway and it makes me feel good.

It is always life or death in the intensive care unit (ICU). Working as an Intensivist, I am exposed to extraordinary situations every day. Thus, prior to walking into the ICU, I make it a point to think of something positive and smile because once those doors open up all Hell can break lose. Lack of personal protective equipment (PPE) because of the COVID-19 pandemic and staff isolation has demoralized everyone. I try my best to provide some encouragement in this very high mortality setting. It is important to let the staff know about those patients that survived so they know they are truly making a difference and see there is light at the end of the tunnel (2).

As Friedrich Nietzsche said, “that which does not kill us, makes us stronger” (1). That saying can be true for some but not all. You have to have a particular mindset in order to learn from these terrible situations and rise above like a phoenix from the ashes. “These life experiences have been called ‘crucibles’, severe test or trial that is unplanned, intense and often traumatic” (3). Unfortunately, not all of us can handle such diversity and may develop post-traumatic stress from such life experiences and never recover. That is why it is important to try and look at such profound life altering events as lessons. There is always something to be learned from every situation. Even negative events can be turned into positive experiences that build on a person’s character. For example, immediately after a COVID-19 surge descended on one hospital I was working at, I immediately learned to question the reliability of the estimated oxygen saturation measured by pulse oximetry (SpO₂) and to intubate as quickly and as safely as I could in order to avoid exposing staff to the SARS-CoV-2 virus as well as preventing cardiac arrest during intubation of those critically ill patients. It was a Sunday, the day before Doctor’s day 2020 in America when all of a sudden, the flood gates opened from the wards and literally five patients within minutes all required immediate intubation because all of them had critical oxygen levels despite maximal high-flow therapy. One after another the patients arrived in succession into the ICU and I went from bed-to-bed intubating all of them. This kicked off many months of treating very high numbers of critically ill patients two to three times the volume I was used to treating. Instead of being overwhelmed by the pressure, I focused on each patient and discovered the best treatment options all the while making sure that I did not add to the depressing morale by complaining about how difficult the working conditions were in order to keep the ICU team motivated. As Winston Churchill repeated during the daily bombardment of England by the Germans in WWII—keep calm and carry on (4).

I had never seen the need for so many arterial blood gas draws (ABG) and neither had the laboratory staff. One evening around midnight I needed around 20 ABGs. Instead of shrinking from the challenge, two laboratory technicians stepped up and brought the machine that processes the ABGs to the ICU and enthusiastically ran all of the tests. This made a huge difference in patients’ outcomes because what I was seeing was a big discrepancy between the continuous patient SpO₂ monitoring and the actual partial pressure oxygen (PaO₂). The true measurement of PaO₂ derived from the ABG helped confirm my suspicion that many patients were actually hypoxic despite having normal readings on the pulse oximeter, allowing me to adjust the ventilator appropriately and preventing death. I praised the laboratory workers in person and let their supervisors know what a terrific job had been done. They never complained despite being understaffed (some of their colleagues quit and never showed up for work that day). The lesson I learned from all of that was that as long as I kept pushing myself, I could save those patients despite the large volume and lack of supplies which gave me a great feeling of accomplishment. I then travelled to other hospitals facing similar situations and was able to continue this way for over a year.

Now I realize that not everyone can handle the pressure that follows a crucible event. I, myself, struggle as well and I have to remind myself to carry on and stay positive, which is not always an easy task. I definitely have not mastered this strategy yet, but I am trying. Marcus Aurelius said “you have the power over your mind – not (on) outside events. Realize this, and you will find strength” (1). Throughout our lives we will encounter hardships but as we get through one and then the other encounter, we realize that we can handle it. Know that the next life event is just another challenge. From the 2^nd century BCE Epicurus reminds us that “a person will never be happy if they are anxious about what they do not have” (1). Use that incredible focus and discipline you summoned from deep within during decades of study to train your mind into thinking positively. “Our life is shaped by our mind; we become what we think. Joy follows a pure thought like a shadow that never leaves,” Gautama Buddha (1). Remain altruistic and continue to take care of those in need and you will live a happy and joyous life.

Evan D. Schmitz, MD

La Jolla, CA USA

References

1. Robledo, IC. 365 Quotes to Live Your Life By. Powerful, Inspiring, & Life-Changing Words of Wisdom to Brighten Up Your Days. Published by I. C. Robledo, 2019.
2. https://www.goodreads.com/quotes/521459-there-is-a-light-at-the-end-of-everytunnel#:~:text=Quotes%20%3E%20Quotable%20Quote,%E2%80%9CThere%20is%20a%20light%20at%20the%20end%20of%20every%20tunnel,to%20be%20longer%20than%20others.%E2%80%9D
3. Warren G. Bennis and Robert J. Thomas. Crucibles of Leadership. 2002. Harvard Business Review.
4. https://london.ac.uk/about-us/history-university-london/story-behind-keep-calm-and-carry.

Cite as: Schmitz ED. Combating Morale Injury Caused by the COVID-19 Pandemic. Southwest J Pulm Crit Care. 2021;22(5):106-8. doi: https://doi.org/10.13175/swjpcc015-21 PDF

The Best Laid Plans of Mice and Men

When writing a grant proposal, many of us do a power analysis to ensure that we will have a sufficient number or “n” to detect a statistically significant difference between two populations. We estimate the number needed in each group by considering the likely intergroup difference and then add additional subjects depending on the number who will not give informed consent, refuse, die, are lost to follow up, etc. Often the number of nonparticipants is estimated based on previous experience, but sometimes a small study is done first called a feasibility study which tests the assumptions about recruitment. For both clinical trials and epidemiologic studies, a pilot or feasibility study also helps assure that participants will be representative of the relevant population (1). (For examples, will only the most seriously ill participate in a drug trial, or will the most vulnerable workers decline participation in a study. Will some drugs only make a difference in early stage or late stage disease, and having Latinx or Native American participants disproportionately refuse to participate in a workplace study creates biases).

In this monh’s SWJPCC we publish a feasibility study from New Mexico which was hoping to test the hypothesis that thoracic malignancies (TMs) are likely higher in New Mexico because of the relative high proportion of the population with occupational exposures in mining and oil/gas extraction which are known risk factors (2).

The authors conducted a feasibility study of adult lifetime occupational history among TM cases using the population-based New Mexico Tumor Registry (NMTR), from 2017- 2018. Despite identifying 400 eligible cases only 43 were able to complete the study mostly due to early mortality and refusals. This 11% completion rate was insufficient to reach a statistically significant conclusion whether New Mexico has statistically significant more TMs than the National average of 10-14%.

After some discussion we decided to publish the manuscript with this editorial to "educate" the SWJPCC readership about the challenges of population-based mortality studies, the persistent risk of occupational thoracic malignancies, and the concept of population burden. The authors worked just as hard getting these unsatisfying results as if they had a study demonstrating the study was feasible. If only the "successful and positive studies" are published, because planning is necessary and lack of planning often resulting in publication bias. Someone in the future will likely ask a similar question hoping to use similar methodology. However, they will now have numbers that might be more realistic or do interventions to decrease refusals, increase valid addresses or increase the number that could be reached by phone.

Richard A. Robbins, MD ¹

Philip Harber, MD, MPH ²

Allen R. Thomas, MD ³

¹ Phoenix Pulmonary and Critical Care Research and Education Foundation, Gilbert, AZ USA

² Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ USA

³ Happily retired, Scottsdale, AZ USA

References

1. Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. [CrossRef] [PubMed]
2. Pestak CR, Boyce TW, Myers OB, Hopkins LO, Wiggins CL, Wissore BR, Sood A, Cook LS. A Population-Based Feasibility Study of Occupation and Thoracic Malignancies in New Mexico. Southwest J Pulm Crit Care. 2021;22(1):23-35. doi: [CrossRef]

Cite as: Robbins RA, Harber P, Thomas AR. The Best Laid Plans of Mice and Men. Southwest J Pulm Crit Care. 2021;22(1):21-22. doi: https://doi.org/10.13175/swjpcc003-21 PDF