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

Clinical Care of COVID-19 Patients in a Front-line ICU

Robert A. Raschke MD

Tyler J. Glenn MD

Kim I. Josen MD

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, AZ USA

These are some clinical observations made after over the past 10 months, working in a busy COVID-19 ICU unit in Scottsdale, AZ. The opinions expressed here are those of the private practice authors.

Overview of triage and rounding on large numbers of COVID-19 patients in the ICU service. Our approach to bedside care of our ICU service has required abbreviation for the sake of efficiency in the face of more than a doubling of our census. Our approach to rounding is opinion-based. We’ve been forced to evolve our triage and rounding systems in order to survive.

Our hospital uses the Abbott ID-Now® rapid point-of -are test for screening all COVID-19-asymptomatic patients admitted to our hospital, but due to its low sensitivity in hospitalized patients (1). We do not trust it to rule-out COVID-19 in patients with pneumonia being admitted to the ICU and also order an in-house PCR for such patients prior to, or upon ICU admission. We are cautious about transferring COVID-19 patients out of the ICU on bilevel positive airway pressure (BiPAP) or high-flow nasal cannula since many such patients have deteriorated and bounced-back to the unit within the subsequent week.

We try to see as many of our COVID-19 ICU patients (who are practically all our patients) sequentially, without interruption if possible, leaving our masks and gowns on continuously and moving quickly from room to room, changing only gloves between patients unless a bacterial pathogen that requires contact isolation has been identified. Little/no helpful information can be gleaned by entering the room of patient who is proned in a rotoprone bed. Such patients may only be supined for brief periods, sometimes in the middle of night shift; and discussion with the nurses regarding their physical exam findings during supine positioning is high yield. Auscultation of COVID-19 patients using isolation stethoscopes is seldom of value. Palpation of the neck/trunk for crepitus, neurological examination (especially in patients emerging from heavy sedation and/or supined after prolonged proning), and assessment of fluid status are high yield. We keep track of how many days the patient has received mechanical ventilation, the cumulative fluid balance (which sometimes gets very positive), and signs and lab values possibly related to complications of COVID-19 discussed below. The duration of antibiotics and sedation medications needs constant monitoring to avoid overuse. We do not routinely follow serial INR, ferritin, CRP, or D-dimer, since these do not affect patient management. We sometimes use BNP and procalcitonin to trigger further cardiac or infectious disease evaluations respectively. We do not treat isolated elevated procalcitonin with antibiotics, nor do we treat isolated d-dimer with therapeutic dose anticoagulation.

We have been conservative in our treatment of COVID-19, relying primarily on dexamethasone and usual evidence-based critical care practice. Over the course of the outbreak, our conservative approach has been validated; various hyped but off-label therapies (hydroxychloroquine, antirheumatic therapies, universal therapeutic anticoagulation) have failed to show benefit and possibly caused harm when subjected to evidence-based scrutiny (2,3). Benefits of remdesivir in patients with advanced respiratory failure seem unclear/minimal (4). Most of our patients present to the ICU in the second or third week of illness, already having developed IgG antibodies and therefore unlikely to benefit from convalescent serum or monoclonal antibodies.

Clinical course and management of respiratory failure. Many patients remain awake and able to tolerate spontaneous ventilation with non-invasive ventilation and/or high-flow nasal canula oxygen delivering high FiO2, for as long as two weeks before they either recover or require endotracheal intubation. Before the current outbreak, it was unusual to manage severely hypoxemic patients without intubation and mechanical ventilation. For COVID-19, it seems to be the norm, with intubation delayed until the last possible moment, as it is unclear that mechanical ventilation with its attendant complications (immobility, sedation, invasive support apparatus) offer any definite benefit. Once intubated, many patients seem to transition abruptly to refractory hypoxemia and hypercarbia, which previously would have made them candidates for Extracorporeal membrane oxygenation (ECMO) transfer. In one recent case, we requested ECMO evaluation for a patient prior to intubation, anticipating that he would deteriorate badly immediately thereafter. The consultant requested intubation before ECMO evaluation, and indeed, once intubated, the patient immediately became too unstable for uncannulated transfer. In general, the numbers of patients fulfilling historical criteria for ECMO consideration have greatly overwhelmed ECMO capacity.

We have tried several approaches to invasive mechanical ventilation, but each has drawbacks. Our primary mode of ventilation, pressure-regulated volume control, has sometimes resulted in high plateau and driving pressures as respiratory system compliance worsens. We’ve used pressure control ventilation in some patients to limit driving pressure, but this has led to unrecognized worsening of respiratory acidosis in some. We have managed several episodes of cardiac arrest due to uncontrolled combined respiratory and metabolic acidosis in COVID-19 patients being treated with permissive hypercapnia ventilation who subsequently developed acute renal failure. We are now trying airway pressure-release ventilation (APRV) as an optional approach in which we try to avoid proning and heavily sedating the patient, but aim for Richmond Agitation-Sedation Scale (RASS) of -1 to -2 and allow maintenance of spontaneous respiratory efforts by the patient during “T high”. It is not clear whether any of these approaches results in better clinical outcomes.

Our use of prone positioning has increased dramatically. Self-proning of awake patients receiving non-invasive mechanical ventilation or high-flow nasal canula oxygen has allowed some to survive episodes of severe oxygen desaturation and avoid intubation. We have extensively utilized proning in mechanically ventilated patients with PaO2/FiO2 <150. Several of our patients experienced cardiopulmonary arrest when briefly supined resulting in several fatalities. Consequently, we have learned to placed US-guided internal jugular central venous catheters and chest tubes in patients in proned and semi-proned positions. We have noted that at some point, prone positioning needs to be abandoned if the patient is ever going to recover, even if their PaO2/FiO2 ratio falls upon supine positioning. In such patients, supine positioning allows reduction of heavy sedation and resumption/improvement of spontaneous breathing efforts that may allow ventilator weaning to slowly proceed.

Complications of COVID-19 in the ICU. We have seen more barotrauma than previously described, some occurring during non-invasive ventilation prior to endotracheal intubation (5). Point of care chest ultrasonography has been instrumental in several cases in which anterior pneumothoraces were not clearly apparent on chest radiography, except perhaps as a deep sulcus sign, and also to rapidly rule-out pneumothorax as a cause of acute cardiopulmonary decompensation.

Hypotension requiring intravenous vasopressors is common (6). In many cases, it seems due to sepsis and sedation with propofol and/or dexmedetomidine. We have occasionally seen acute or chronic cardiomyopathy, but not as often as noted early in the pandemic (7). We have repeatedly diagnosed relative adrenal insufficiency later in the hospital course –after dexamethasone has been discontinued. Such patients commonly received etomidate during intubation which could possibly be contributory.

Bacterial co-infections are uncommon at presentation, consistent with published meta-analysis (8), and we do not routinely give antibiotics to all patients with COVID-19 pneumonia up front. Later in the course of mechanical ventilation, many patients experience recurrent fever, leukocytosis, elevated procalcitonin and/or worsening pulmonary status prompting endotracheal secretion and blood cultures and empirical antibiotics. We have commonly isolated a wide variety of potential bacterial pathogens from the respiratory secretions of such patients including methicillin-sensitive Staphylococcus aureus (MRSA), methicillin-resistant Staphylococcus aureus (MRSA), gram negative rods, some multi-drug resistant. We recently isolated carbapenem-resistant Enterobacter. It is uncertain whether these represent true cases of secondary pneumonia.

Coagulopathy related to COVID-19 is complex and increased risk of thrombosis and bleeding seem apparent (9). We administer enhanced prophylactic-dose anticoagulation to all our patients (typically 40mg enoxaparin every 12 hours in patients without morbid obesity or renal failure), but do not treat elevated d-dimers with therapeutic anticoagulation in the absence of documented venous thromboembolism (4). A minority of our patients have had documented venous thromboemboli prior to ICU admission and a few have had acute myocardial infarctions and strokes. We try to get CT angiography of the chest and doppler ultrasound of the lower extremities on all patients requiring mechanical ventilation. Bedside ultrasonography demonstrating acute right heart failure has been helpful in a few cases in which pulmonary emboli were suspected but the patient too unstable for CT angio or VQ scan. Three of our patients experienced CNS hemorrhages, two of which were fatal. Gastrointestinal bleeding is not uncommon.

Acute renal failure is common and complicates permissive hypercarbia, sometimes necessitating high dose bicarbonate infusions (6). Circuit thrombosis during dialysis is common, perhaps a manifestation of COVID-19 coagulopathy, and sometime necessitating therapeutic anticoagulation.

End of life issues. It is our impression that the mortality in intubated patients is higher this winter than it was previously in the pandemic. This might be because patients are receiving more aggressive therapy earlier in the course of illness, and often are only intubated after failing a prolonged course of non-invasive mechanical ventilation. Perhaps this selects treatment-unresponsive patients for intubation. Prognostication seems very difficult. We treated an 89-year patient with severe comorbidities who rapidly recovered after a 4-day course of mechanical ventilation and a 28-year-old previously healthy man who died despite receiving veno-venous ECMO. We have not found clinical scoring systems such as

Sequential Organ Failure Assessment (SOFA) to be helpful in prognosis, since many patients have isolated severe single organ dysfunction at the time of ICU admission, and therefore have similar SOFA scores – mostly comprised of points given for severe respiratory failure. Old-fashioned bedside common sense and family discussion still seem the best approach to determining code status. It is logistically difficult/impossible to safely administer CPR to some patients who are proned, especially those that are morbidly obese. We have told families that we are instituting limited code status (no CPR, no ACLS) in such situations, subsequently discussing resumption of full code status if/when the patient recovers enough to tolerate resumption of supine positioning.

Psychosocial issues. Incredible emotional injury is being experienced by patients’ families. Several of our patients come from families in which two or three primary relatives have already died from COVID-19. We called one patient’s wife to inform her that her husband had narrowly survived a prolonged arrest secondary to pneumothorax, interrupting her during her son’s funeral, who had died from COVID-19 pneumonia the previous week. Eventually, that family suffered the death of three primary relatives from COVID-19 over the course of three weeks.

We have tried to use cellular technology to help mitigate restricted family visitation, but it seems a poor substitute. Our nurses have had some patients make cell phone video messages to their loved ones before intubation – sometimes the last memory their families will ever have of them. We have held our cellphones by the ears of COVID-19 patients as they are dying so that their loved ones can say goodbye. It was heart-wrenching to hear a husband of 42 years sobbing uncontrollably over the phone, telling his dying wife that he loved her, and how much he’s going to miss her as we prepared to remove her endotracheal tube to let her die.

The nurses, respiratory techs and physicians have shown incredible bravery and self-sacrifice and outward morale is good. But all are suffering severe vicarious injuries the full effect of which may not be apparent for years to come. Much of the human connection previously so important to ICU practice has been lost – few of the patients can interact, and the families are generally not allowed to visit. We simply don’t have the time anymore to call them as often as we would like, and it’s unusual to call them with good news. We should plan for a future increase in PTSD and burn-out among healthcare providers.

We are grateful to have received my COVID-19 vaccination, and I was sincerely astounded by the organizational excellence of the vaccination event implemented by HonorHealth here in Phoenix. They did a very good job that will serve our entire vaccine-willing population in the coming months.

References

1. Basu A, Zinger T, Inglima K, Woo KM, Atie O, Yurasits L, See B, Aguero-Rosenfeld ME. Performance of Abbott ID Now COVID-19 Rapid Nucleic Acid Amplification Test Using Nasopharyngeal Swabs Transported in Viral Transport Media and Dry Nasal Swabs in a New York City Academic Institution. J Clin Microbiol. 2020 Jul 23;58(8):e01136-20. [CrossRef] [PubMed]
2. WHO Solidarity Trial Consortium, Pan H, Peto R, Henao-Restrepo AM, et al. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med. 2020 Dec 2:NEJMoa2023184. [CrossRef] [PubMed]
3. Salama C, Han J, Yau L, et al. Tocilizumab in Patients Hospitalized with COVID-19 Pneumonia. N Engl J Med. 2020 Dec 17. [CrossRef] [PubMed]
4. American Society of Hematology. COVID-19 Resources: COVID-19 and VTE/Anticoagulation: Frequently asked questions. Version 5.1 (last updated December 24, 2020). Available at: https://www.hematology.org/covid-19/covid-19-and-vte-anticoagulation (accessed 1/3/21).
5. Botta M, Tsonas AM, Pillay J, et al., PRoVENT-COVID Collaborative Group. Ventilation management and clinical outcomes in invasively ventilated patients with COVID-19 (PRoVENT-COVID): a national, multicentre, observational cohort study. Lancet Respir Med. 2020 Oct 23:S2213-2600(20)30459-8. [CrossRef] [PubMed]
6. Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020 Jun 6;395(10239):1763-1770. [CrossRef] [PubMed]
7. Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. [CrossRef] [PubMed]
8. Langford BJ, So M, Raybardhan S, Leung V, Westwood D, MacFadden DR, Soucy JR, Daneman N. Bacterial co-infection and secondary infection in patients with COVID-19: a living rapid review and meta-analysis. Clin Microbiol Infect. 2020 Dec;26(12):1622-1629. [CrossRef] [PubMed]
9. Helms J, Tacquard C, Severac F, et al., CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. [CrossRef] [PubMed]
10. Hayek SS, Brenner SK, Azam TU, et al. In-hospital cardiac arrest in critically ill patients with covid-19: multicenter cohort study. BMJ. 2020 Sep 30;371:m3513. [CrossRef] [PubMed]

Cite as: Raschke RA, Glenn TJ, Josen KI. Clinical Care of COVID-19 Patients in a Front-line ICU. Southwest J Pulm Crit Care. 2021;22(1):11-15. doi: https://doi.org/10.13175/swjpcc070-20 PDF

Why My Experience as a Patient Led Me to Join Osler’s Alliance

There are a number of books and articles written by doctors that relate their own experience as patients. Count this as another although I promise it will not be nearly as entertaining as “The House of God”. Over a month ago I became short of breath and a chest x-ray revealed left lower lobe consolidation. Despite lack of fever, it seemed that an infectious process was most likely, and when multiple tests for COVID-19 were negative, it was felt by my pulmonary physician to be most likely coccidioidomycosis despite a negative cocci serology. After beginning on empirical therapy with fluconazole for nearly a month, I am feeling better.

Most of us know that there is considerable laboratory to laboratory variation in serologic tests for Valley Fever (1). However, when my initial cocci serology was negative, efforts to send it a good reference lab such as Pappagianis’ Lab at UC Davis became nearly impossible. After making an appointment at Sonora Quest and waiting a week for an appointment to get my blood drawn, it was apparently sent to Davis, but when payment was not assured, it was not run. I would have been paid for it out of pocket but there seemed no way to communicate this.

Similarly, it took 3 visits to a commercial outpatient radiology practice, Simon Med, to get a routine chest x-ray. I can understand the need for appointments for CT scans. However, routine x-rays were so backed up that I waited several hours to get a chest x-ray performed although I did get an electronic copy. Fortunately, I am able to read my own chest x-ray and did not need to wait for a radiologist’s report which arrived on a Tuesday after the chest x-ray was taken late on a Friday.

Honestly, I had no idea that our patients were receiving such poor care. Delays of this magnitude go beyond what I view as acceptable. Overall, I think my doctors are great but I have concerns about an overall decline in patient care. It should not take a week to get routine labs drawn. Sick people should not be making multiple trips to get a simple chest x-ray. This may be another symptom of the hyperfinancializaton of medicine where patient care is sacrificed for profit. The hospital labs and x-ray departments of years ago were run by physicians and mostly concerned with patient care and not losing money. Today with businessmen controlling nearly all aspects of healthcare patient care is less important than maximizing profits.

I worry that our businessmen/managers are buying medical practices and directly supervising healthcare professionals. Healthcare is a business to them, no different than selling hamburgers at McDonalds. Their goals of increasing income and reducing expenses to maximize profits while hiding behind the façade of a non-profit organization is quite apparent. However, what is equally clear is that there is a lack of medical knowledge in these medical managers and decisions can be “penny wise but dollar foolish”. Look at the decision to not pay for a more reliable cocci serology which costs $80. They have spent more than this on fluconazole. Bad medicine is usually costly.  

The COVID-19 pandemic has brought to light many of the inadequacies of business interests dominating medicine (2). Hospitals are overflowing and inadequate personnel with inadequate personal protective equipment are available to care for them. Those remaining providers are expected to just “pick up the slack”.

Although I have long lamented (some say whined) about the businessmen’s mismanagement of medicine, what could we do? Business interests seemed to control the hospitals, the insurance companies, Centers for Medicare and Medicaid Services (CMS), and the licensing boards. We were being squeezed and trainees just beginning practice were in no position either financially or professionally to confront business interests which could end their career.

I appear to not be the only one who feels way. Last year, Eric Topol MD, founder and director of the Scripps Research Translational Institute and editor-in-chief of Medscape, wrote a piece published in The New Yorker, "Why Doctors Should Organize” (3). In it, he explained his view that the nation's nearly 900,000 practicing doctors needed to organize to bring back the doctor-patient relationship that existed before the business part of medicine took over its soul. Physician organizations such as the American Medical Association (AMA) represents only about 17% of US physicians, and have done little for medicine as a profession. The next largest, the American College of Physicians, represents internal-medicine specialists. Most of the smaller societies (e.g., ATS, American College of Chest Physicians) represent a subspecialty and have correspondingly fewer members each. The AMA once represented three-fourths of American doctors; the growth of subspecialty societies may have contributed to its diminishment. In any case, there is no single organization that unifies all doctors. The profession is balkanized into different specialties each hostilely eyeing the other specialty organizations.

Therefore, Topol has led the formation of Osler's Alliance (now Medicine Forward) (4). This organization, named for William Osler, hopes to draw together the nation's doctors, who come from different backgrounds, specialties, and political leanings but agree that the way they interact with patients is not what they envisioned when they decided to devote their lives to medicine.

"Such an organization wouldn't be a trade guild protecting the interests of doctors," Topol wrote. "It would be a doctors' organization devoted to patients (5)."Another organizer of Osler's Alliance, Esther Choo, MD, MPH, an emergency physician and professor at Oregon Health & Science University in Portland, described physicians' widespread daily feeling that "this can't be the way it's supposed to be," but also a lack of empowerment to make changes (5). That's where the numbers come in, she said. A massive group of physicians standing up against practices could force change.

The first step, Choo said, is to break down the fundamental mission into "bite-sized advocacy (5)." That might entail advocating for answers to why increased documentation demands are necessary and how, specifically, they help the patient rather than dutifully complying with directives for more charting.

The leaders emphasize that membership in the group is not about money, which is why it's only $5 a year. Signing up builds support and allows access to chat streams and information in a broad network. "When you start seeing advertisements for health systems that say, 'We give the gift of time to patients and clinicians,' " answered Topol, "then we'll know we're turning the right corner (5)."

If you are a physician or other provider, you might consider joining Osler’s Alliance. What have you and your patients got to lose? Staying the present course would seem to lead to nowhere.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Galgiani JN, Knox K, Rundbaken C, Siever J. Common mistakes in managing pulmonary coccidioidomycosis. Southwest J Pulm Crit Care. 2015;10(5):238-49. doi: http://dx.doi.org/10.13175/swjpcc054-15
2. Dorsett M. Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician's perspective. Sci Adv. 2020 Jun 26;6(26):eabc5354. [CrossRef] [PubMed]
3. Topol E. Why Doctors Should Organize. The New Yorker. August 5, 2019. Available at: https://www.newyorker.com/culture/annals-of-inquiry/why-doctors-should-organize (accessed 11/30/20).
4. Osler’s Alliance website. Available at: https://oslersalliance.mn.co/about (accessed 11-30-20).
5. Frellick M. Medical Leaders Launch Grassroots Doctors' Alliance. Medscape. November 25, 2020. Available at https://www.medscape.com/viewarticle/941623 (accessed 12/30/20).

Cite as: Robbins RA. Why My Experience as a Patient Led Me to Join Osler’s Alliance. Southwest J Pulm Crit Care. 2020;21(6):138-40. doi: https://doi.org/10.13175/swjpcc066-20 PDF

Correct Scoring of Hypopneas in Obstructive Sleep Apnea Reduces Cardiovascular Morbidity

James M. Parish, MD¹

David Baratz, MD²

¹Mayo Clinic Arizona; Phoenix, AZ USA

²Pulmonary Associates, Phoenix, AZ USA

Obstructive Sleep Apnea (OSA) is a life-altering disease with a prevalence of 10% in men and 9% in women (1). In some groups (severe obesity, BMI > 40 kg/m2) the prevalence may be as high as 40% (2). One of the most controversial areas in the field of sleep medicine for many years has been the definition of the syndrome. Investigators who first identified OSA created the apnea index (AI), the number of apnea events per hour. An apnea was defined as a complete cessation of airflow for at least 10 seconds. When continuous positive airway pressure (CPAP) treatment for OSA was first introduced, a definition that third-party payors, such as the Center for Medicare and Medicaid Services (CMS), could use to determine which patients qualified for treatment was needed. The definition at that time was 30 apnea events during a 6-hour recording, which corresponded to an AI of 5 events per hour. As further information developed about the syndrome of OSA, the presence of the hypopnea was recognized. A hypopnea was an event that was not a complete cessation of airflow, but rather was a reduction in airflow associated with either a reduction of oxygen saturation and/or an arousal from sleep. Hypopneas were found to have the same clinical significance as apneas. However, controversy surrounded the exact definition of hypopnea. What percentage reduction in airflow? What degree of desaturation, 3%, 4%, other? (3) And what was the exact definition of arousal? Additionally, at this time, CMS would not recognize the use of hypopneas in the definition of OSA for the purpose of qualifying patients for the use of CPAP and a result, many patients with predominantly hypopneas did not meet the qualifications for CPAP.

Subsequently, an agreement between the sleep community and CMS was reached utilizing the definition of hypopnea of a reduction of airflow to 30% of baseline and a 4% oxygen desaturation (4). This definition was based on findings from the Sleep Heart Health Study demonstrating significant cardiovascular effects in patients with obstructive sleep apnea/hypopnea syndrome utilizing this definition. The association of hypopnea with arousal was left out of this definition at this time because there was poor reproducibility in scoring. While the benefit of this agreement was the inclusion of hypopneas which allowed more patients to qualify for PAP therapy, there was a large group of individuals with hypopneas with 3% desaturation and/or an arousal who did not meet the criteria for therapy.

In 2012 the American Academy of Sleep Medicine (AASM) recommended that the hypopnea definition include any decrease in airflow by at least 30% from the baseline with an oxygen desaturation of at least 3% or an arousal from sleep (5,6). This definition often forced many sleep laboratories to score studies twice, once using the 3% rule and the other using the 4% rule. The 3%-4% controversy has continued for many years.

Since then CMS and other payors has not adopted the recommendation of the AASM primarily because of lack of evidence that a 3% decrease is associated with cardiovascular disease and relied on a more restrictive definition of OSA fewer patients with OSA (as defined by the AASM) have been able to obtain life changing therapy such as CPAP. In the view of many, this has increased the risk of developing cardiovascular disease.

In this issue of SWJPCC an article by Quan et al., “The Association Between Obstructive Sleep Apnea Defined by 3 Percent Oxygen Desaturation or Arousal Definition and Self-Reported Cardiovascular Disease in the Sleep Heart Health Study” demonstrates that employing a definition of hypopnea utilizing a 3% reduction in the oxygen desaturation results in an equivalent incidence of cardiovascular disease (CVD) or coronary heart disease (CHD) as the more restrictive 4% definition (7). The shows that in patients followed in the Sleep Heart Health Study (SHHS) that 6307 participants developed CVD/CHD at equal rates based on odds ratios and 95% confidence intervals.  The SHHS was a prospective multicenter cohort study designed to investigate the relationship between OSA and CVD (8).  6441 subjects 40 years and older were recruited in 1995 to undergo polysomnography, having demographic information taken and then self-report if they were ever told by a doctor that they had angina, heart attack, heart failure, stroke or undergone coronary bypass surgery or coronary angioplasty. CHD or CVD was defined as a positive response to one or more of these conditions or procedures. In addition, the presence of hypertension, diabetes, depression, insomnia and hypersomnia in these subjects was assessed.

In this current analysis of the SHHS 3326 participants were found not to have OSA by the 4% CMS rule. Using the 3% AASM definition of hypopnea, 2247 of the 3326 participants were found to have OSA. Participants that were not diagnosed by the 4% rule had OSA ranging in the mild to severe categories. This study suggests that the regulatory requirement by the CMS of using a 4% decrease in oxygen desaturation denies a substantial number of patients the opportunity for treatment of their OSA and may worsen cardiovascular disease or coronary heart disease.

This paper is the first to assess the association of the 3% criteria in the risk of developing CVD/CHD in patients with OSA. The importance of this paper cannot be underestimated.  There are no other studies that have been done or are being done that investigate the risk between OSA or cardiovascular disease using polysomnographic measurements. By utilizing the 3% rule in clinical practice a much larger number of patients would meet the diagnostic criteria of OSA and be eligible to receive treatment.

Treatment of OSA with CPAP has been shown to reduce the severity of CVD, CHD, diabetes, motor vehicle accidents. It also improves daytime alertness, concentration, emotional stability, reduces snoring, and reduces medical expenses (9-11).

The current study provides the necessary information to help resolve the ongoing controversy. The studies data is very robust, using the well-known Sleep Heart Health study. A limitation of the study is that it relies on self-reported history of cardiovascular disease, which is subject to recall bias, but the data is otherwise very strong and robust. Also, some of the correlations are less statistically significant when adjusted for other co-variates.

This study provides proof that a large number of patients with symptomatic and dangerous OSA have been undertreated. It calls for a change in the policy by the CMS and all other payors to provide therapy for patients with OSA based on the American Academy of Sleep Medicine criteria using a 3% reduction in oxygen saturation to score hypopneas.

References

1. Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. [CrossRef] [PubMed]
2. Rajala R, Partinen M, Sane T, Pelkonen R, Huikuri K, Seppäläinen AM. Obstructive sleep apnoea syndrome in morbidly obese patients. J Intern Med. 1991 Aug;230(2):125-9. [CrossRef] [PubMed]
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5. Anonymous. CPAP for Obstructive Sleep Apnea Updated 2020. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/CPAP. 
6. Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. [CrossRef] PMID: [PubMed]
7. Quan SF, Budhiraja R, Javaheri S, Parthasarathy S, Berry RB. The Association Between Obstructive Sleep Apnea Defined by 3 Percent Oxygen Desaturation or Arousal Definition and Self-Reported Cardiovascular Disease in the Sleep Heart Health Study. Southwest J Pulm Crit Care. 2020;21(4):86-103. [PubMed]
8. Quan SF, Howard BV, Iber C, Kiley JP, Nieto FJ, O'Connor GT, Rapoport DM, Redline S, Robbins J, Samet JM, Wahl PW. The Sleep Heart Health Study: design, rationale, and methods. Sleep. 1997 Dec;20(12):1077-85. [PubMed]
9. Javaheri S, Barbe F, Campos-Rodriguez F, Dempsey JA, Khayat R, Javaheri S, Malhotra A, Martinez-Garcia MA, Mehra R, Pack AI, Polotsky VY, Redline S, Somers VK. Sleep Apnea: Types, Mechanisms, and Clinical Cardiovascular Consequences. J Am Coll Cardiol. 2017 Feb 21;69(7):841-858. [CrossRef] [PubMed]
10. McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. [CrossRef] [PubMed].
11. Anonymous. CPAP – Benefits and Health Risk Prevention. AASM. Sleep Education. 2015, Aug. 10. Available at: http://sleepeducation.org/essentials-in-sleep/cpap/benefits (accessed 10/18/20).

Cite as: Parish JM, Baratz D. Correct Scoring of Hypopneas in Obstructive Sleep Apnea Reduces Cardiovascular Morbidity. Southwest J Pulm Crit Care. 2020;21(4):104-7. doi: https://doi.org/10.13175/swjpcc059-20 PDF

Trump’s COVID-19 Case Exposes Inequalities in the Healthcare System

Early Friday morning (October 2, 2020) President Trump announced through Twitter that he had tested positive for COVID-19 (aka SARS-CoV-2). Later Friday afternoon he was whisked away by helicopter for a 10-minute ride to Walter Reed National Military Medical Center (WRNMMC, formerly Bethesda Naval Medical Center) which is across the street from the National Institutes of Health campus in Bethesda. There he received REGN-COV2, a combination of two monoclonal antibodies (REGN10933 and REGN10987) directed against the spike protein of the COVID-19 virus. In addition, he received a dose of remdesivir (an antiviral drug) as well as zinc, vitamin D, famotidine (Pepcid®), melatonin and aspirin. As of Saturday morning, Trump has done well by all accounts.

All the therapies administered to Trump are unproven but have some evidence supporting their use against COVID-19. The Trump administration issued an emergency use authorization for remdesivir earlier this year after the drug showed moderate effectiveness in improving outcomes for patients who were hospitalized with the coronavirus (1). REGN-COV2 is now in Phase 3 clinical trials, is still experimental and has not received emergency use approval from the FDA. However, it had sufficient evidence for President Trump to receive the drug in response to a compassionate use request to the manufacturer (2). There is also some evidence that the other ancillary therapies might be useful therapies against COVID-19 (3-7).

What these therapies have in common is that the available scientific evidence of their efficacy was funded, at least in part, by the US government, most prominently the FDA’s Coronavirus Treatment Acceleration Program (CTAP) (8). The US government has spent several billion dollars on COVID-19 therapies including $450 million on REGN-COV2 and at least $75 million for remdesivir (9,10). The success of the program is remarkable in light of the disbanding of the National Security Council pandemic unit which had predicted the disaster we are now enduring (11). The ingenuity of the scientific community is truly amazing when motivated by billions of dollars. Those Americans who actually pay taxes should be proud of their government officials for making such successful investments on their behalf.

President Trump’s care is in contrast to my own or the general public. I recently became ill with increasing shortness of breath, orthopnea and a nonproductive cough but no fever. Because I have a history of diastolic dysfunction, I had assumed this was heart failure. As a physician who has many friends in the medical community, I am privileged to be able to call my cardiologist who saw me later that day. The general public might well have had to accept his next available appointment which was over 3 months or go to an emergency room. After 2 days, and 5 trips to a free-standing radiology center and 2 trips to a laboratory testing site, it became clear that I had left lower pneumonia by chest-x-ray and a normal brain naturetic peptide. Later that day I went to a free-standing clinic and had a rapid COVID-19 test which was negative. Because my presentation was atypical for bacterial pneumonia, I called my pulmonary physician who also saw me later that day. He ordered a coccioidomycosis serology and a COVID-19 test by PCR. The former because of the high possibility of Valley Fever which can cause up to a third of community-acquired pneumonias in Arizona and the latter because of the poor sensitivity of the rapid COVID-19 antibody test (12,13). However, I was not able to schedule the collection of the nasal swab or blood for 10 days at a free-standing laboratory. This seems excessively long and my pulmonologist decided against empirical treatment for Valley Fever because of a potential drug interaction with one of my heart medications (dofetilide).

President Trump often brags that the US has the greatest healthcare system in the world and for him it is. Although he repeatedly touted ineffective therapies for COVID-19 such as hydroxychloroquine, bleach and light and belittled those who wore masks, when he got sick only scientifically based therapy was used despite the expense (14). The general public probably does not have President Trump’s or my access to physicians. Donald Trump, the White House staff, and some professional athletes are getting daily COVID-19 tests but the rest of us taxpayers are forced to wait 10 days to get a nasal swab and a blood sample drawn.

USA Today is now reporting that President Trump had earned capital gains from Regeneron Pharmaceuticals and Gilead Sciences, the manufacturers of REGN-COV2 and remdesivir (15). According to a 2017 financial disclosure form filed with the U.S. Office of Government Ethics in June 2017, Trump had a capital gain of $50,001 to $100,000 for Regeneron Pharmaceuticals and $100,001 to $1 million for Gilead. Trump’s subsequent disclosure forms, including his 2020 form signed July 31, did not list Regeneron or Gilead. Ostensibly, he, other family members and close associates sold their stocks to avoid any apparent conflict of interest.

Based on previous experience, I remain skeptical that therapies developed and distributed by our tax monies will really be free. Will the clever businessmen who run drug companies take money from the US government for product development and then bill a hefty sum for their product? Will the rush to develop a vaccine before the November elections put expediency over safety? Some vaccines rushed to market such as the polio vaccine of 1955 or the swine flu vaccine of 1976 resulted in serious side effects in some recipients (16). As Trump is so fond of saying, “We will have to wait and see”.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. FDA. COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19. August 28, 2020. Available at: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized#:~:text=Today%2C%20as%20part%20of%20its,laboratory%2Dconfirmed%20COVID%2D19%2C (accessed 10/3/20).
2. Farr C, Stankiewicz K. Here’s everything we know about the unapproved antibody drug Trump took to combat coronavirus. CNBC. October 2, 2020. Available at: https://www.cnbc.com/2020/10/02/what-we-know-about-regeneron-antibody-drug-trump-took-to-combat-coronavirus.html (accessed 10/3/20).
3. Arentz S, Yang G, Goldenberg J, et al. Clinical significance summary: Preliminary results of a rapid review of zinc for the prevention and treatment of SARS-CoV-2 and other acute viral respiratory infections [published online ahead of print, 2020 Aug 1]. Adv Integr Med. 2020;10.1016/j.aimed.2020.07.009. [CrossRef] [PubMed]
4. Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcalá Díaz JF, López Miranda J, Bouillon R, Quesada Gomez JM. "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study". J Steroid Biochem Mol Biol. 2020 Oct;203:105751. [CrossRef] [PubMed]
5. Freedberg DE, Conigliaro J, Wang TC, Tracey KJ, Callahan MV, Abrams JA; Famotidine Research Group. Famotidine Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study. Gastroenterology. 2020 Sep;159(3):1129-1131.e3. [CrossRef] [PubMed]
6. Zhang R, Wang X, Ni L, et al. COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020;250:117583. [CrossRef] [PubMed]
7. Mohamed-Hussein AAR, Aly KME, Ibrahim MAA. Should aspirin be used for prophylaxis of COVID-19-induced coagulopathy? Med Hypotheses. 2020 Jun 8;144:109975. [CrossRef] [PubMed]
8. FDA. Coronavirus Treatment Acceleration Program (CTAP). Available at: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap (accessed 10/3/20).
9. Loftus P, Walker J.  U.S. Commits $2 Billion for Covid-19 Vaccine, Drug Supplies. Wall Street Journal. July 7, 2020. Available at: https://www.wsj.com/articles/u-s-commits-2-billion-for-covid-19-vaccine-drug-supplies-11594132175 (accessed 10/3/20).
10. Public Citizen. The Public Already Has Paid for Remdesivir. Available at: https://www.citizen.org/news/the-public-already-has-paid-for-remdesivir/ (accessed 10/3/20).
11. Riechmann D. Trump disbanded NSC pandemic unit that experts had praised. AP News. March 14, 2020. Available at: https://apnews.com/article/ce014d94b64e98b7203b873e56f80e9a (accessed 10/3/20).
12. Valdivia L, Nix D, Wright M, Lindberg E, Fagan T, Lieberman D, et al. Coccidioidomycosis as a common cause of community-acquired pneumonia. Emerg Infect Dis. 2006;12(6):958-62. [CrossRef] [Pubmed]
13. Guglielmi G. Fast coronavirus tests: what they can and can't do. Nature. 2020 Sep;585(7826):496-498. [CrossRef] [PubMed]
14. Robbins RA. Lack of natural scientific ability. Southwest J Pulm Crit Care. 2020;21(1):15-22. [CrossRef]
15. Tyko K. Trump COVID-19 treatment: President had stakes in Regeneron and Gilead, makers of antibody cocktail, Remdesivir. USA Today. October 3, 2020. Available at: https://www.usatoday.com/story/money/2020/10/03/trump-walter-reed-treatment-president-regeneron-gilead-remdesivir/3610111001/ (accessed 10/3/20).
16. Trogen B, Oshinsky D, Caplan A. Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust. JAMA. 2020 Jun 23;323(24):2460-2461. [CrossRef] [PubMed]

Cite as: Robbins RA. Trump’s COVID-19 Case Exposes Inequalities in the Healthcare System. Southwest J Pulm Crit Care. 2020;21(4):82-5. doi: https://doi.org/10.13175/swjpcc055-20 PDF 

Lack of Natural Scientific Ability

Back in March President Trump suggested he would have thrived in another profession, medical expert (1). Despite no training or experience, Trump boasted “I like this stuff. I really get it”. Citing a “great, super-genius uncle” who taught at MIT, Trump professed that it must run in the family genes. Trump went on to say “People are really surprised I understand this stuff … Maybe I have a natural ability.”

This was followed by a series of White House briefings where Trump and members of his White House Coronavirus Task Force spoke on the COVID-19 pandemic. Trump tried to dominate these conferences and repeatedly lied about the coronavirus pandemic and the country’s preparation for this once-in-a-generation crisis. Below is a partial list of 35 of the biggest lies about the COVID-19 pandemic he’s told as the nation endures a public-health and economic calamity are in Table 1 (2). 

Table 1. Partial list of Trump lies regarding the COVID-19 pandemic (2).

Date	Trump claim	Truth
2/7/20	The coronavirus would weaken “when we get into April, in the warmer weather—that has a very negative effect on that, and that type of a virus.”	Respiratory viruses can be seasonal, but the COVID-19 can be transmitted in ALL AREAS, including areas with hot and humid weather and is clearly not diminishing.
2/27/20	The outbreak would be temporary: “It’s going to disappear. One day it’s like a miracle—it will disappear.”	Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, warned days later that he was concerned that “as the next week or two or three go by, we’re going to see a lot more community-related cases.”
Multiple times	The claim: If the economic shutdown continues, deaths by suicide “definitely would be in far greater numbers than the numbers that we’re talking about” for COVID-19 deaths.	The number of people who died by suicide in the US in 2017 was roughly 47,000, nowhere near the COVID-19 deaths now at about 147,000 (3).
Multiple times	“Coronavirus numbers are looking MUCH better, going down almost everywhere,” and cases are “coming way down.”	Most states now have rising COVID-19 cases, hospitalizations and deaths (3).
7/2/20	The pandemic is “getting under control.”	Most states now have rising COVID-19 cases, hospitalizations and deaths (3). It is not under control.
7/4/20	“99%” of COVID-19 cases are “totally harmless.”	The evidence shows that the virus “can make you seriously ill” even if it doesn’t kill you
7/6/20	“We now have the lowest Fatality (Mortality) Rate in the World.”	The U.S. has neither the lowest mortality rate nor the lowest case-fatality rate (3).
3/4/20	“The Obama administration made a decision on [laboratory] testing that turned out to be very detrimental to what we’re doing.”	The Trump White House rolled back Food and Drug Administration regulations that limited the kind of laboratory tests states could run and how they could conduct them.
3/13/20	The Obama White House’s response to the H1N1 pandemic was “a full scale disaster, with thousands dying, and nothing meaningful done to fix the testing problem, until now.”	Barack Obama declared a public-health emergency two weeks after the first U.S. cases of H1N1 were reported, in California. Trump declared a national emergency more than seven weeks after the first domestic COVID-19 case was reported, in Washington State. While testing is a problem now, it wasn’t back in 2009. The challenge then was vaccine development: Production was delayed and the vaccine wasn’t distributed until the outbreak was already waning.
Multiple times	The Trump White House “inherited” a “broken,” “bad,” and “obsolete” test for the coronavirus.	The novel coronavirus did not exist in humans during the Obama administration.
Multiple times	The Obama administration left Trump “bare” and “empty” shelves of medical supplies in the national strategic stockpile.	The stockpile’s former director said in 2019, before the coronavirus pandemic, that it was well-equipped. The outbreak has since eaten away at its reserves.
5/10/20	Trump attacked “Joe Biden’s handling of the H1N1 Swine Flu.”	Biden was not responsible for the federal government’s response to the H1N1 outbreak.
3/6/20 & 5/11/20	“Anybody that needs a test, gets a test. We—they’re there. They have the tests. And the tests are beautiful” and “If somebody wants to be tested right now, they’ll be able to be tested.”	Trump made these two claims two months apart, but the truth is still the same: The U.S. does not have enough testing.
3/24 & 3/25/20	The United States has outpaced South Korea’s COVID-19 testing: “We’re going up proportionally very rapidly,” Trump said during a Fox News town hall.	When the president made this claim, testing in the U.S. was severely lagging behind that in South Korea. As of March 25, South Korea had conducted about five times as many tests as a proportion of its population relative to the United States.
5/11/20	America has “developed a testing capacity unmatched and unrivaled anywhere in the world, and it’s not even close.”	The United States is still not testing enough people and is lagging behind the testing and tracing capabilities that other countries have developed.
Multiple times	“Cases are going up in the U.S. because we are testing far more than any other country.”	COVID-19 cases are not rising because of “our big-number testing.” Outside the Northeast, the share of tests conducted that come back positive is increasing, with the sharpest spike happening in southern states. In some states, such as Arizona and Florida, the number of new cases being reported is outpacing any increase in the states’ testing ability. And as states set new daily case records and report increasing hospitalizations, all signs point to a worsening crisis.
3/11/20	The United States would suspend “all travel from Europe, except the United Kingdom, for the next 30 days.”	The travel restriction would not apply to U.S. citizens, legal permanent residents, or their families returning from Europe.
3/12/20	All U.S. citizens arriving from Europe would be subject to medical screening, COVID-19 testing, and quarantine if necessary. “If an American is coming back or anybody is coming back, we’re testing,” Trump said. “We have a tremendous testing setup where people coming in have to be tested … We’re not putting them on planes if it shows positive, but if they do come here, we’re quarantining.”	Testing was already severely limited in the United States at the time Trump made this claim. It was not true that all Americans returning to the country are being tested, nor that anyone is being forced to quarantine.
3/31/20	“We stopped all of Europe” with a travel ban. “We started with certain parts of Italy, and then all of Italy. Then we saw Spain. Then I said, ‘Stop Europe; let’s stop Europe. We have to stop them from coming here.’”	The travel ban applied to the Schengen Area, as well as the United Kingdom and Ireland, and not all of Europe as he claimed.
Multiple times	“Everybody thought I was wrong” about implementing restrictions on travelers from China, and “most people felt they should not close it down—that we shouldn’t close down to China.”	The travel ban was the “uniform” recommendation of the Department of Health and Human Services.
Multiple times	travel restrictions on China were a “ban” that closed up the “entire” United States and “kept China out.”	Nearly 40,000 people traveled from China to the United States from February 2, when Trump’s travel restrictions went into effect, to April 4.
3/17/20	I’ve always known this is a real—this is a pandemic. I felt it was a pandemic long before it was called a pandemic … I’ve always viewed it as very serious.”	Trump has repeatedly downplayed the significance of COVID-19 as outbreaks began stateside. From calling criticism of his handling of the virus a “hoax,” to comparing the coronavirus to a common flu, to worrying about letting sick Americans off cruise ships because they would increase the number of confirmed cases, Trump has used his public statements to send mixed messages and sow doubt about the outbreak’s seriousness.
3/26/20	This kind of pandemic “was something nobody thought could happen … Nobody would have ever thought a thing like this could have happened.”	Experts both inside and outside the federal government sounded the alarm many times in the past decade about the potential for a devastating global pandemic.
3/2/20	Pharmaceutical companies are going “to have vaccines, I think, relatively soon.”	The president’s own experts told him during a White House meeting with pharmaceutical leaders earlier that same day that a vaccine could take a year to 18 months to develop.
3/19/20	Trump said the FDA had approved the antimalarial drug chloroquine to treat COVID-19. “Normally the FDA would take a long time to approve something like that, and it’s—it was approved very, very quickly and it’s now approved by prescription,” he said.	FDA Commissioner Stephen Hahn quickly clarified that the drug still had to be tested in a clinical setting.
3/23/20	Trump suggested in a briefing on April 23 that his medical experts should research the use of powerful light and injected disinfectants to treat COVID-19.	Trump walked this statement back the next day, saying he was being “sarcastic”.
5/8/20	The coronavirus is “going to go away without a vaccine … and we’re not going to see it again, hopefully, after a period of time.”	Tony Fauci has said that until there is “a scientifically sound, safe, and effective vaccine” the pandemic will not be over.
Multiple times	Taking hydroxychloroquine to treat COVID-19 is safe. “You’re not going to get sick or die,” Trump said on one occasion. “It doesn’t hurt people,” he commented on another.	Trump’s own FDA has warned against taking the antimalarial drug with or without the antibiotic azithromycin, which Trump has also promoted.
5/9/20	“One bad” study from the Department of Veterans Affairs that found no benefit among veterans who took hydroxychloroquine to treat COVID-19 was run by “people that aren’t big Trump fans.” The study “was a Trump-enemy statement.”	There’s no evidence that the study was a political plot orchestrated by Trump opponents, and it reached similar conclusions as other observational reports. The VA study was led by independent researchers from the University of Virginia and the University of South Carolina with a grant from the National Institutes of Health.
3/20/20	Trump twice said during a task-force briefing that he had invoked the Defense Production Act (DPA), a Korean War–era law that enables the federal government to order private industry to produce certain items and materials for national use. He also said the federal government was already using its authority under the law: “We have a lot of people working very hard to do ventilators and various other things.”	Federal Emergency Management Agency Administrator Peter Gaynor told CNN on March 22 that the president has not actually used the DPA to order private companies to produce anything. Shortly after that, Trump backtracked, saying that he had not compelled private companies to take action. Then, on March 24, Gaynor told CNN that FEMA plans to use the DPA to allocate 60,000 test kits. Trump tweeted afterward that the DPA would not be used.
3/21/20	Automobile companies that have volunteered to manufacture medical equipment, such as ventilators, are “making them right now.”	Ford and General Motors, which Trump mentioned at a task-force briefing the same day, announced earlier in March that they had halted all factory production in North America and were likely months away from beginning production of ventilators.
3/24/20	Governor Andrew Cuomo of New York passed on an opportunity to purchase 16,000 ventilators at a low cost in 2015, Trump said during the Fox News town hall.	Trump seems to have gleaned this claim from a Gateway Pundit article. There is no evidence that Cuomo was offered the ventilators or turned any offer down.
3/29/20	Trump “didn’t say” that governors do not need all the medical equipment they are requesting from the federal government. And he “didn’t say” that governors should be more appreciative of the help.	Trump told Fox News’ Sean Hannity on Thursday, March 26, that “a lot of equipment’s being asked for that I don’t think they’ll need,” referring to requests from the governors of Michigan, New York, and Washington. He also said, during a Friday, March 27, task-force briefing, that he wanted state leaders “to be appreciative … We’ve done a great job.”
3/29 and 3/30/20	Hospitals are reporting an artificially inflated need for masks and equipment, items that might be “going out the back door,” Trump said on two separate days. He also said he was not talking about hoarding: “I think maybe it’s worse than hoarding.”	There is no evidence to show that hospitals are maliciously hoarding or inflating their need for masks and personal protective equipment when reporting shortages in supplies.
4/14/20	Asked about his past praise of China and its transparency, Trump said that he hadn’t “talk[ed] about China’s transparency.”	Trump lauded the country in tweets he sent in late January and early February. In one, he highlighted the Chinese government’s “transparency” about the coronavirus outbreak.
3/29/20	WHO ignored “credible reports” of the coronavirus’s spread in Wuhan, the Chinese city that first reported the new virus, including those published in The Lancet medical journal in December.	The Lancet said it did not publish such reports in December. Its first reports on the virus’s spread in Wuhan were published on January 24.

Trump eventually stopped the news briefings in face of their declining popularity and public trust and being outshone by Tony Fauci MD, director of National Institute of Allergy and Infectious Disease. Fauci is best known as an expert virologist for his handling of the Acquired Immunodeficiency Disease Syndrome (AIDS). He has faithfully served his patients, the American people, through six presidential administrations, providing sound, science‐based guidance. However, he has been wrong. Two examples are not recommending masks early in the COVID-19 pandemic and stating that few COVID-19 patients were asymptomatic (4). However, both were based on the best available scientific evidence of the time which turned out to be wrong. In neither instance was Fauci’s honesty questioned and, in both instances, Fauci self-corrected those errors.

The strained relationship between the White House and Fauci has been apparent for months. Trump was visibly annoyed when Fauci spoke at news briefings (5). In April Trump retweeted a call to fire Fauci during early criticism of Trump’s mishandling of the COVID-19 pandemic (6). He has attempted to silence Fauci’s inconvenient scientific voice from testifying before Congress and giving TV interviews (7). More recently, he has tried an old tactic of having aides and underlings attack opponents and then evaluating how it plays with the public. If it goes well Trump repeats it, but if it does not, he says the aide was acting on his own. The White House let their top economic advisor, Peter Navarro, attack Fauci in an USA Today op-ed (8). Last Sunday, White House scientific advisor Brett Girori MD tried to undermine Fauci last Sunday on Meet the Press saying Fauci only looks at the COVID-19 pandemic from “a very narrow public health point of view”; doesn’t “have the whole national interest in mind’; and repeated the White House opposition to Fauci’s call for states experiencing COVID-19 surges to pause their reopening processes (9).

The attacks against Fauci were apparently unsuccessful. Referring to the White House attacks, Fauci remained calm saying, “I cannot figure out in my wildest dreams why they would want to do that” (10). New polling from Quinnipiac University found that 65% of voters trust the information Fauci is providing about the coronavirus while only 30% trust the information provided by Trump (11). In the face of the polls favorable to Fauci, the White House is now distancing itself from Navarro saying he went rogue failing to obtain proper clearance for his op-ed (12).

In a closely related event, the Trump Administration has mandated that hospitals sidestep the Centers for Disease Control and Prevention and send critical information about COVID-19 hospitalizations and equipment to a different federal database (13). From the start of the pandemic, the CDC has collected data on COVID-19 hospitalizations, availability of intensive care beds and personal protective equipment. The change sparked concerns that the administration was hobbling the ability of the nation's public health agency to gather and analyze crucial data in the midst of a pandemic. It further allows data to be manipulated, altered or spun for political purposes. The decision raises serious questions about the credibility, transparency, and availability of data needed by public health officials, researchers, and physician leaders to advance science-based and data-driven decision-making. The White House has lied enough to show they cannot be trusted with data needed for responses to the COVID-19 pandemic such as reopening.

The scientific data is what it is. It has no philosophy, no politics, and is often not what we want it to be. During this pandemic which is the most catastrophic public health disaster since the “Spanish Flu” of 1918, we need scientific leadership to ensure that the data is driving our responses and not being driven by a political agenda. Leaders like Tony Fauci are needed for this pandemic. Others who attempt to undermine Fauci for their own nefarious political purposes will hopefully be ignored by the public. Nonscientific wags who claim scientific abilities they do not have do not really get it. They will likely lead us towards a cataclysmic catastrophe that could be diminished with sensible decisions made on the basis of science rather than politics.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Nakamura D. ‘Maybe I have a natural ability’: Trump plays medical expert on coronavirus by second-guessing the professionals. Washington Post. March 6, 2020. Available at:  https://www.washingtonpost.com/politics/maybe-i-have-a-natural-ability-trump-plays-medical-expert-on-coronavirus-by-second-guessing-the-professionals/2020/03/06/3ee0574c-5ffb-11ea-9055-5fa12981bbbf_story.html (accessed 7/17/20).
2. Paz C. All the president’s lies about the coronavirus. The Atlantic. July 13, 2020. https://www.theatlantic.com/politics/archive/2020/07/trumps-lies-about-coronavirus/608647/ (accessed 7/17/20).
3. Coronavirus Resource Center. Johns Hopkins University. Available at: https://coronavirus.jhu.edu/ (accessed 7/17/20).
4. Panetta G. Fauci says he doesn't regret telling Americans not to wear masks at the beginning of the pandemic. Business Insider. Jul 16, 2020. Available at: https://www.businessinsider.com/fauci-doesnt-regret-advising-against-masks-early-in-pandemic-2020-7 (accessed 7/17/20).
5. Lahut J. Trump is reportedly getting frustrated with Dr. Fauci's 'blunt approach' during White House press conferences. Business Insider. Mar 23, 2020. Available at: https://www.businessinsider.com/trump-reportedly-growing-frustrated-with-dr-faucis-blunt-approach-2020-3 (accessed 7/17/20).
6. Brewster J. Trump retweets call to fire Fauci after he criticized U.S. response to virus. April 13, 2020. Available at: https://www.forbes.com/sites/jackbrewster/2020/04/13/trump-retweets-call-to-fire-fauci-after-he-criticized-us-response-to-virus/#47860ca451d6 (accessed 7/17/20).
7. Pramuk J. White House blocks Fauci from testifying at House coronavirus hearing. CNBC. May 1, 2020. Available at: https://www.cnbc.com/2020/05/01/anthony-fauci-blocked-from-testifying-at-house-coronavirus-hearing.html (accessed 7/17/20).
8. Navarro P. Anthony Fauci has been wrong about everything I have interacted with him on. USA Today. July 14, 2020. Available at: https://www.usatoday.com/story/opinion/todaysdebate/2020/07/14/anthony-fauci-wrong-with-me-peter-navarro-editorials-debates/5439374002/ (accessed 7/17/20).
9. Meet the Press. July 12, 2020. https://www.nbcnews.com/meet-the-press/video/adm-brett-grior-dr-fauci-is-not-100-percent-right-about-covid-19-response-87536197610 (accessed 7/17/20).
10. Nicholas P, Yong E. 1.        Fauci: ‘Bizarre’ White House Behavior Only Hurts the President. July 15, 2020. Available at: https://www.theatlantic.com/politics/archive/2020/07/trump-fauci-coronavirus-pandemic-oppo/614224/ (accessed 7/17/20).
11. Stelter B. New poll reaffirms that most Americans don't trust the President, but they do trust Dr. Fauci. CNN Business. July 16, 2020. Available at: https://www.cnn.com/2020/07/15/media/poll-trump-fauci-reliable-sources/index.html (accessed 7/17/20).
12. Samuels B. White House distances itself from Navarro op-ed bashing Fauci. The Hill. 07/15/20. Available at: https://thehill.com/homenews/administration/507406-white-house-distances-itself-from-navarro-op-ed-bashing-fauci (accessed 7/17/20).
13. Huang P, Simmons-Duffin S.  White House strips CDC of data collection role for COVID-19 hospitalizations. NPR. July 15, 2020. https://www.npr.org/sections/health-shots/2020/07/15/891351706/white-house-strips-cdc-of-data-collection-role-for-covid-19-hospitalizations (accessed 7/17/20).

Cite as: Robbins RA. Lack of natural scientific ability. Southwest J Pulm Crit Care. 2020;21(1):15-22. doi: https://doi.org/10.13175/swjpcc044-20 PDF 

What the COVID-19 Pandemic Should Teach Us

As I write this between telemedicine patients on June 16^th, I am reflecting back on the pandemic and what we have learned so far, not in how to diagnose or care for the COVID-19 patients, but in government and healthcare administration’s response to the pandemic.

Politicians have made both good and poor decisions regarding the COVID-19 pandemic. In the summer of 2005, President George W. Bush was on vacation at his ranch in Crawford, Texas, when he began flipping through an advance reading copy of a new book about the 1918 influenza pandemic (1). He couldn't put it down. What was born was the nation's most comprehensive pandemic plan -- a playbook that included diagrams for a global early warning system, funding to develop new, rapid vaccine technology, and a robust national stockpile of critical supplies, such as face masks and ventilators. Bush’s remarks from 15 years ago still resonate. "If we wait for a pandemic to appear," he warned, "it will be too late to prepare. And one day many lives could be needlessly lost because we failed to act today."

In what will probably go down as some of the worse timing in history, the Trump administration eliminated or severely cut funding to these Bush-era programs (2). In March of 2018, Timothy Ziemer, whose job it was to lead the United States response in the event of a pandemic, abruptly left the administration and his global health security team was disbanded. In February 2020 the administration released its proposed federal budget proposal for fiscal year 2021, calling for a cut of more than $693 million at the Centers for Disease Control and Prevention, as well as a $742 million cut to programs at the Health Resources and Services Administration. Overall, the president’s budget proposed a 9% funding cut at the U.S. Department of Health and Human Services. More recently the US has pulled out of the World Health Organization with the dubious timing of being in the middle of this pandemic. In addition, Trump downplayed the pandemic from the beginning and has ignored the advice of virtually every epidemiologist encouraging “opening up” the country ignoring accelerating COVID-19 cases and death tolls (2,3).

In Arizona early in the pandemic we were doing OK with most businesses shut down and people by and large staying at home. Our clinic was closed although we continued to see telemedicine patients. However, Governor Ducey, under the apparent urging of Trump, “opened up” the state beginning May 15 resulting in an apparent resurgence of COVID-19 cases. No word from Ducey, the Arizona State Department of Health Services or Maricopa Health and Human Services on how we should respond to the resurgence. I cannot find any admission by any of the governors, and certainly not Trump, that states that prematurely “opened up” was a mistake.

Misinformation is everywhere. Everyone with a computer and no or inadequate medical education has suddenly become an expert in COVID-19. My inbox is flooded with multiple emails from people I do not know espousing their latest theories, guidelines, unproven treatments, or passing along the latest internet COVID-19 chatter.

This disinformation is potentially dangerous but the scientific community has also made mistakes. For example, a controversial study led by Didier Raoult from Marseilles on the combination of hydroxychloroquine and azithromycin for patients with COVID-19 was published March 20 (4). It showed a reduction in viral load and “clinical improvement compared to the natural progression.” This was picked by several including Trump who claimed to be taking hydroxychloroquine as a preventative. Papers purporting to show that hydroxychloroquine was ineffective were published in the New England Journal of Medicine and the Lancet. These have been retracted since the database from which they were derived was found to be unreliable (5). These studies have only added to the confusion of hydroxychloroquine’s effectiveness in COVID-19.

Government and hospitals were unprepared. In 2009, a smaller pandemic due to H1N1 swept through the United States (6). Ventilators, ICU beds, and adequate numbers of healthcare providers were in short supply despite the Bush administration’s attempt at preparedness (7). When the pandemic resolved no additional preparations were made for another and larger pandemic. Disturbingly, when the current COVID-19 pandemic occurred there were inadequate numbers of ventilators for patients and inadequate protection for healthcare workers. In some instances, personal protective equipment was not allowed to be used (8). There was no response from the federal government or hospitals. What could they do? They needed the physicians and nurses to care for the tidal wave of patients exposing the healthcare workers to COVID-19. To date about 600 healthcare workers have died during the COVID-19 pandemic and it will likely go much higher.

Healthcare hyperfinancializaton was the source for the unpreparedness. The source of this unpreparedness at both the national and local level was a desire to save money since a pandemic was viewed by decision makers as unlikely in the near future. Cutting taxes and maximizing profits were the real goals and preparation for a pandemic was not viewed as a priority especially since it interfered with the real goal of making money. We are now paying the price for these short-sighted decisions. Since the federal government has markedly increased the federal debt with a COVID-19 bailout, we will likely continue to pay the price with higher taxes and/or by cutting other government programs viewed as low priorities. Some of these programs may prove to be as potentially valuable as the trashed pandemic plan.

As a country we need to start thinking about how to approach these decisions in the future. In my view, the present system of politicians and businessmen serving as healthcare decision makers has been an abysmal failure. The COVID-19 pandemic is but one example of this failure. Clearer heads both in government and healthcare regulation such as the Joint Commission need to become more concerned that the voices of knowledgeable people such as Tony Fauci are heard. Until we develop such a system, we can anticipate healthcare to be unprepared for calamities such as the COVID-19 pandemic they occur in the future.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Mosk M. George W. Bush in 2005: 'If we wait for a pandemic to appear, it will be too late to prepare'. A book about the 1918 flu pandemic spurred the government to action. ABC News. April 5, 2020. Available at: https://abcnews.go.com/Politics/george-bush-2005-wait-pandemic-late-prepare/story?id=69979013 (accessed 6/16/20).
2. Morris C. Trump administration budget cuts could become a major problem as coronavirus spreads. Fortune. February 26, 2020. Available at: https://fortune.com/2020/02/26/coronavirus-covid-19-cdc-budget-cuts-us-trump/ (accessed 6/16/20).
3. Fadel L. Public health experts say many states are opening too soon to do so safely. NPR. Weekend Edition. May 9, 2020. Available at: https://www.npr.org/2020/05/09/853052174/public-health-experts-say-many-states-are-opening-too-soon-to-do-so-safely (accessed 6/16/20).
4. Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial [published online ahead of print, 2020 Mar 20]. Int J Antimicrob Agents. 2020;105949. [CrossRef] [PubMed]
5. Gumbrecht J, Fox M. Two coronavirus studies retracted after questions emerge about data. CNN. June 4, 2020. Available at: https://www.cnn.com/2020/06/04/health/retraction-coronavirus-studies-lancet-nejm/index.html (accessed 6/16/20).
6. CDC. 2009 H1N1 pandemic (H1N1pdm09 virus). Available at: https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html (accessed 6/16/20).
7. WHO. Shortage of personal protective equipment endangering health workers worldwide. Available at: https://www.who.int/news-room/detail/03-03-2020-shortage-of-personal-protective-equipment-endangering-health-workers-worldwide (accessed 6/16/20).
8. Sathya C. Why would hospitals forbid physicians and nurses from wearing masks? Sci Am. March 26, 2020. Available at: https://blogs.scientificamerican.com/observations/why-would-hospitals-forbid-physicians-and-nurses-from-wearing-masks/ (accessed 6/17/20).

Cite as: Robbins RA. What the COVID-19 pandemic should teach us. Southwest J Pulm Crit Care. 2020;20(6):192-4. doi: https://doi.org/10.13175/swjpcc042-20 PDF 

Improving Testing for COVID-19 for the Rural Southwestern American Indian Tribes

Arshia Chhabra¹

Varinn Sood²

Vanita Sood, MD³

Akshay Sood, MD, MPH^4,5

¹La Cueva High School, 7801 Wilshire Ave NE, Albuquerque, NM USA

²Albuquerque Academy, 6400 Wyoming Blvd. NE, Albuquerque, NM USA

³Andrew Weil Center for Integrative Medicine, University of Arizona, 655 N Alvernon Way, Tucson, AZ USA;

⁴Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM USA; ⁵Black Lung Program, Miners’ Colfax Medical Center, Raton, NM, USA.

Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome-related coronavirus-2 (SARS–CoV-2) infection. The United States (US) currently has more officially reported cases and deaths from COVID-19 than any other country in the world. The rural Southwestern American Indian (SAI) tribes are disproportionately affected, due to genetics, immunological naivety, social determinants of health, and high prevalence of concomitant comorbidities and co-exposures (1). On March 30, 2020, the New Mexico Governor, Michelle Lujan Grisham, informed the US President Donald Trump of the “incredible spikes” in cases of COVID-19 within the Navajo Nation in the rural Four Corners region of the American Southwest (2). The Governor warned that the disease “... could wipe out those tribal nations.”

Use of COVID-19 testing as an approach to combating the pandemic is supported by an Iceland-based epidemiological study, and endorsed by the World Health Organization (3). Rural states in the US rank higher in prevalence of COVID-19 risk factors (hypertension, obesity, and diabetes), but rank lower in overall testing rates (4). Notably, several Southwestern states such as Arizona, Texas and Oklahoma have among the lowest testing rates in the country (5). Taken together, these results suggest that the current COVID-19 surveillance does not effectively capture medically vulnerable rural populations in the Southwest (4). Testing in the SAI tribal communities is further limited by the following reasons: 1) misinformation on tests due to the lack of broadband Internet access; 2) inadequate access to test sites due to lack of transportation and long travel distances; 3) traditional mistrust of the healthcare system; 4) concern about mishandling of biological samples; 5) misunderstanding that molecular assays interpret the genetic structure of the virus and not their people; 6) difficulty paying for the tests; and 7) nationwide shortage of test kits. Buy-in from community leaders and traditional healers, utilizing culturally sensitive communications, and access to broadband Internet are crucial to improving effective testing-based surveillance in these communities.

A large number of molecular and serological tests for COVID-19 are currently available, many of which lack evaluation data. Molecular tests, useful for establishing a diagnosis, utilize respiratory tract specimens to assess for the presence of nucleic acid targets specific to SARS–CoV-2 using the reverse transcriptase-polymerase chain reaction (RT-PCR) or nucleic acid amplification assays. RT-PCR–based assays performed in the laboratory on nasopharyngeal swabs collected by trained professionals are currently the cornerstone of COVID-19 diagnostic testing. Most RT-PCR assays take a few hours to complete, but the Cepheid assay has shortened the test duration to 45 minutes (6). Recent molecular tests such as CRISPR-Case12-based lateral flow assay and Abbott ID Now™, utilizing isothermal nucleic acid amplification technology for the qualitative detection of viral RNA have shortened the turnaround time further (7). Unlike molecular tests, serological tests may be useful in public health surveillance and vaccine evaluation, but not as the sole test for diagnosing the acute stage of the disease (8). Performed on blood specimens, serological tests use formats such as enzyme-linked immunosorbent assay and rapid lateral flow immunoassay, to detect immunoglobulin M (IgM) and/or immunoglobulin G (IgG) antibodies, which are produced by the body at approximately 10 days and 20 days respectively following COVID-19 infection. Current molecular and serological tests are laboratory-based and not easily available in the SAI tribal settings.

Living far away from hospitals, rural SAI residents need easy access to sample collection venues.  Across the world, many different sample collection venues can serve as useful prototypes, which includes drive-through-, booth-, mobile laboratory-, and home-based approaches. The latter approach involves the use of self-test kits, which are ideal. The approach involves kits containing instructions for testees to self-collect nasal swabs (or possibly early morning salivary specimens (9)) for molecular tests, or finger-stick blood samples for serologic tests. The FDA recently granted emergency clearance to the first at-home molecular test, a nasal self-swab kit (Pixel, LabCorp, USA), with a mail-back to the company laboratory for conducting the PCR assay, with online access to the results (10).

Although not currently available, the ideal test for the SAI tribal settings is low cost, less complex, point of care, rapid (i.e., test turn-around time preferably within an hour), and able to be performed by non-laboratory professionals in low-infrastructure settings, such as homes. The test results could be potentially uploaded to a mobile app or be viewed over a telemedicine consultation to interpret the results and provide immediate counseling on the next step. Smartphone-based devices containing a cartridge-housed microfluidic chip, which carries out isothermal amplification of viral nucleic acids from nasal swab samples in 30 minutes, which are detected using the smartphone camera, may soon be available for home testing (11). Rapid point of care serologic tests, similar to finger-stick blood glucose tests, and home pregnancy tests with colorimetric reading, mal also soon become available for home testing (12).To take advantage of rapid point-of-care testing that will soon become available, improving access to smartphones and broadband Internet in SAI tribal communities is crucial.

The primary goal of the pandemic containment in the rural SAI tribal communities is to reduce the basic reproductive number (R0, the expected number of cases directly generated by one case) of the SARS–CoV-2 virus, thereby reducing disease transmission. Given the lack of effective vaccines or treatments, the only currently available levers to reduce SARS–CoV-2 transmission are to practice social isolation, universal masking, and hand hygiene, identify asymptomatic and symptomatic infected cases through ideal testing strategies, and isolate contagious persons (8). Although not currently available, the ideal test for SAI communities is point of care, rapid, and home-based and requires efforts to improve access to smartphones and broadband Internet. Testing can be popularized using community leaders and traditional indigenous care providers. Finally, policy solutions are needed to eliminate financial barriers for uninsured or underinsured patients, to help meet the goal of improving testing-based COVID-19 surveillance in the rural SAI tribal communities.

References

1. Kakol M, Upson D, Sood A. Susceptibility of southwestern american Indian tribes to coronavirus disease 2019 (COVID-19). J Rural Health. 2020. [CrossRef] [PubMed]
2. Faulders K, Rubin O. New Mexico's governor warns tribal nations could be 'wiped out' by coronavirus, https://abcnews.go.com/Politics/mexicos-governor-warns-tribal-nations-wiped-coronavirus, published March 30, 2020,  accessed on April 3, 2020: ABC news (online); 2020.
3. Gudbjartsson DF, Helgason A, Jonsson H, Magnusson OT, Melsted P, Norddahl GL, et al. Spread of SARS-CoV-2 in the Icelandic population. N Engl J Med. 2020 Apr 14.  [Epub ahead of print] [CrossRef] [PubMed]
4. Souch JM, Cossman JS. A commentary on rural-urban disparities in covid-19 testing rates per 100,000 and risk factors. J Rural Health. 2020 Apr 13. [Epub ahead of print] [CrossRef] [PubMed]
5. Monnat SM. Why coronavirus could hit rural areas harder. Available at https://lernercenter.syr.edu/2020/03/24/why-coronavirus-could-hit-rural-areas-harder/.  Printed March 24, 2020. Accessed March 26, 2020. Learner Center for Health Promotion.
6. Xpert®Xpress SARS-CoV-2. Available online: https://www.cepheid.com/coronavirus. March 21,2020. (accessed on 2 April 2020).
7. Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes. Available online: https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes.  March 27, 2020. (accessed on 2 April 2020)
8. Cheng MP, Papenburg J, Desjardins M, Kanjilal S, Quach C, Libman M, et al. Diagnostic testing for severe acute respiratory syndrome-related coronavirus-2: a narrative review. Ann Intern Med. 2020 Apr 13. [Epub ahead of print] [CrossRef] [PubMed]
9. To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-74. [CrossRef] [PubMed]
10. LabCorp. Pixel by LabCorp, COVID-19 At-Home Kits. Available at https://www.pixel.labcorp.com/covid-19. Accessed April 23, 2020.
11. Sun F, Ganguli A, Nguyen J, Brisbin R, Shanmugam K, Hirschberg DL, et al. Smartphone-based multiplex 30-minute nucleic acid test of live virus from nasal swab extract. Lab Chip. 2020 May 5;20(9):1621-7. [CrossRef] [PubMed]
12. Vashist SK. In vitro diagnostic assays for covid-19: recent advances and emerging trends. Diagnostics (Basel). 2020 Apr 5;10(4). pii: E202. [CrossRef] [PubMed]

Cite as: Chhabra A, Sood V, Sood V, Sood A. Improving testing for COVID-19 for the rural Southwestern American Indian tribes. Southwest J Pulm Crit Care. 2020;20(5):175-8. doi: https://doi.org/10.13175/swjpcc037-20 PDF

Does the BCG Vaccine Offer Any Protection Against Coronavirus Disease 2019?

Mueez Rehman¹

Akshay Sood MD, MPH^2,3

¹University of New Mexico Main Campus, Albuquerque, NM, USA

²Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM USA

³Black Lung Program, Miners’ Colfax Medical Center, Raton, NM, USA

Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus-2 (SARS-COV2), shares features with diseases caused by other coronaviruses such as influenza, the Severe Acute Respiratory Syndrome (SARS) outbreak of 2003, and the Middle East Respiratory syndrome (MERS) outbreak of 2012. COVID-19 has been a challenging and devastating pandemic, resulting in death rates of more than 1%, testing nations both rich and poor, and outlining the importance of strong public health programs. Social distancing, masking and hand washing have become the new norm. Healthcare professionals are on the front lines, risking their lives. Those with pre-existing health conditions or older individuals face a significant risk for complications.

As scientists race to understand this deadly virus and find a cure to protect millions, an unlikely ally may come in a vaccine created over 100 years ago. The Bacillus Calmette-Guérin or BCG vaccine was created in 1921 to protect against tuberculosis (TB). At the time, tuberculosis was widespread, and the BCG vaccine was quickly implemented globally. However, as tuberculosis rates declined, developed countries such as the United States and many European countries discontinued widespread BCG administration. This change in vaccination policy was due to the supply of the vaccine and concerns for its efficacy. On the other hand, countries such as India, Pakistan, Indonesia, Vietnam, Russia, Ethiopia, and many others have continued widespread administration of the BCG vaccine. Many of these countries still have high rates of tuberculosis infections, as well as a large percentage of their population live in poverty (1). When COVID-19 started to emerge as a pandemic, global leaders and public health officials feared this pandemic would have catastrophic effects on these countries, overwhelming their healthcare systems, and killing millions. Interestingly, the opposite outcome was observed as these countries reported low rates of COVID-19. Instead, Europe became the world’s first epicenter outside of mainland China, followed by the United States, both of which reported large infection rates and death tolls due to COVID-19. The hardest hit countries had a similarity in that, they did not require widespread neonatal BCG vaccination. Ultimately, it is possible that the key difference between rates of COVID-19 infections in nations lies in neonatal BCG immunization rates amongst the populations. However, these conclusions are subject to confounding variables, such as the strength of the public health programs, and testing and reporting rates for COVID-19. An interesting outlier is Iran, which implemented a nationwide BCG vaccination program late in 1984, for children less than 6 years of age, using the Pasteur strain (2). With the high rates of COVID-19 cases in Iran, further research needs to examine this outlier, to see if there is any association with the type of vaccine used, administration at a later age, or the fact that currently middle-aged and elderly Iranians are not universally vaccinated.

Another interesting observation comes from the COVID-19 racial/ethnic distribution in the United States. The Centers for Disease Control and Prevention (CDC) released the race/ethnicity data for 580 lab-confirmed COVID-19, hospitalized patients on April 8, 2020 (3). In this data, African Americans constituted 33% of patients (when compared to 18% in the catchment populations) while Asians constituted 5.5% of the patients (proportion of Asians in the catchment population was not described). In certain states, Asian American populations showed higher disease and death rates for COVID-19, when compared to the general population (4). Interpretation of this data is, however, subject to confounding variables. The racial category for the Asian population is reported differently throughout the nation. Many states have differing definitions for the Asian race, certain states fail to divide the Asian population into different subgroups, and others combine Asian populations with ‘other’ racial groups (5). Furthermore, because the US does not have a widespread COVID-19 testing program, certain communities lack access to tests, and disparities for groups may be hidden. Once comprehensive data is available, it would be interesting to examine if the Asian subgroups consisting of individuals who received the BCG vaccine from a BCG administering country, before immigrating to the US show better outcomes against COVID-19, when compared to other Asian American subgroups.

The BCG vaccine was created by Albert Calmette and Camille Guérin against a live attenuated strain of Mycobacterium bovis, a mycobacterium that is similar to the one that causes tuberculosis. The vaccine creates both specific immunity to that mycobacterium, as well as nonspecific immunity against other pathogens that cause respiratory tract infections. In a study conducted on mice, researchers found that when subjecting mice to infectious viruses such as the A0 and A2 influenza viruses, herpes simplex virus, as well as other highly infectious viruses, mice inoculated with BCG were found to exhibit a significantly higher resistance to these infections compared to control mice (6). An explanation for this finding may lie in the fact that the BCG vaccine results in innate immune memory in the host. This trained immunity works by reprogramming a host’s bone marrow hematopoietic stem cells and multipotent progenitors through epigenetic/metabolic changes, resulting in greater variability of the differentiated innate immune cells response following a pathogen (7). Ultimately, this may result in the host’s immune system being able to successfully fight off large numbers of respiratory tract infections, including possibly SARS-CoV-2.

The World Health Organization (WHO) stands firm on the stance that there is no scientific evidence as to whether the BCG vaccine actually protects against COVID-19. Furthermore, WHO mentions that BCG vaccination is particularly important for children in countries with high prevalence of tuberculosis, and if local supplies are diverted, these children will face an increase in disease and death from tuberculosis (8).

As more scientific research is being conducted, the preliminary findings may indicate BCG as a potential safeguard against COVID-19. This may be explained through the lower rates of infection in countries with widespread neonatal BCG vaccination policies. Furthermore, immigrants who come from BCG administering countries may also have this advantage against COVID-19. Currently, the US Government is working to release a racial/ethnic breakdown of COVID-19 cases. As more data is published on race and ethnicities, it will be useful to examine if fewer COVID-19 cases and deaths occur amongst immigrant populations from BCG-administering parent countries, after adjusting for confounders.

References

1. Zwerling A, Behr MA, Verma A, et al. The BCG World Atlas: A Database of Global BCG Vaccination Policies and Practices. PLoS Med. 2011 Mar;8(3):e1001012. [CrossRef] [PubMed]
2. Fallah F, Nasiri MJ, Pormohammad A. Bacillus Calmette-Guerin (BCG) vaccine in Iran. J Clin Tuberc Other Mycobact Dis. 2018;11:22. [CrossRef] [PubMed]
3. Garg S, Kim L, Whitaker M, et al. Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019 - COVID-NET, 14 States, March 1-30, 2020. MMWR Morb Mortal Wkly Rep. 2020;69.458-64. [CrossRef] [PubMed]
4. NYC Health. Age-adjusted rates of lab confirmed COVID-19 non-hospitalized cases, estimated non-fatal hospitalized cases, and patients known to have died 100,000 by race/ethnicity group as of April 16, 2020. Available at https://www1.nyc.gov/assets/doh/downloads/pdf/imm/covid-19-deaths-race-ethnicity-04162020-1.pdf; Printed April 16, 2020. Accessed May 1, 2020.
5. Growing Data Underscore that Communities of Color are Being Harder Hit by COVID-19 | The Henry J. Kaiser Family Foundation. https://www.kff.org/coronavirus-policy-watch/growing-data-underscore-communities-color-harder-hit-covid-19/?utm_source=sfmc&utm_medium=email&utm_campaign=covidexternal&utm_content=newsletter. Accessed April 24, 2020.
6. Floc’h F, Werner GH. Increased resistance to virus infections of mice inoculated with BCG (Bacillus calmette-guérin). Ann Immunol (Paris). 1976;127(2):173-86. [PubMed]
7. Gursel M, Gursel I. Is global BCG vaccination coverage relevant to the progression of SARS-CoV-2 Pandemic? Allergy. 2020 Apr 27. [CrossRef] [PubMed]
8. World Health Organization. Bacille Calmette-Guérin (BCG) vaccination and COVID-19. https://www.who.int/news-room/commentaries/detail/bacille-calmette-guérin-(bcg)-vaccination-and-covid-19. Accessed April 14, 2020.

Cite as: Rehman M, Sood A. Does the BCG vaccine offer any protection against coronavirus disease 2019? Southwest J Pulm Crit Care. 2020;20(5):170-2. doi: https://doi.org/10.13175/swjpcc035-20 PDF 

2020 International Year of the Nurse and Midwife and International Nurses’ Day

Carol M. Baldwin, PhD, RN, CHTP, CT, AHN-BC, FAAN

Edson College of Nursing & Health Innovation

Arizona State University

Phoenix, AZ USA

Barbara M. Dossey, PhD, RN, AHN-BC, FAAN, HWNC-BC

Nightingale Initiative for Global Health (NIGH)

Washington, DC USA

The World Health Organization (WHO) designated 2020 as the International Year of the Nurse and Midwife to acknowledge the contributions of nurses and midwives in promoting the health and welfare of populations across the globe. This recognition is in concert with the 200^th anniversary of the birth of Florence Nightingale. Although nurses and midwives make up over half the world’s health care workforce, the WHO estimates that 2020 will see a shortage of 9 million nurses (1,2). International Nurses’ Week begins May 6^th and culminates on May 12^th, International Nurses Day, the anniversary of Nightingale’s birth with hopes of bringing greater re, cognition nurses play in local to global health.

Defying expected Victorian norms for women born to well-connected, affluent British families in the middle of the nineteenth century, Florence Nightingale chose the art and science of nursing over marriage. “Nightingale” is synonymous with the foundation of professional nursing, as well as her dedicated service as a manager and trainer of nurses during the Crimean War.

Florence Nightingale’s influence, however, encompasses so much more than establishing nursing education. Military and field medicine, epidemiology, early prefabricated hospitals, hospital supervision, community and public health, health policy, establishment of nursing schools and infirmaries, early pioneering in the concept of medical tourism, as well as social reform for women and all sections of society have benefitted from her groundbreaking achievements. Her work continues. The Nightingale Initiative for Global Health (NIGH), for example, fosters Nightingale’s activities grounded in social and environmental justice, preventive medicine, and holistic health from the local to global levels (3,4).

A keen observer of conditions that lead to poor health, Nightingale wrote extensively regarding sanitary reform. Her Notes on Nursing emphasized frequent handwashing that presaged the hygiene required during the current Covid-19 pandemic (5). Nightingale was the first woman admitted to the London Statistical Society (5). She became a member of the American Statistical Association (6). She was the first nurse to conduct and use research. Nightingale showed that physical and social factors influenced health, and that quality of care can be improved through careful data collection, visual displays that used her original “Polar-Area Diagram,” critical thinking, and practice based on evidence (7).

Florence Nightingale’s legacy endures in the face of the Covid-19 pandemic. It was announced on 24 March 2020 that the new “Nightingale Hospital” would be set up at the ExCel conference centre in East London to provide support for up to 4,000 patients with Covid-19 (8). On 3 April 2020, within two weeks of the announcement, the NHS Nightingale Hospital was officially opened by HRH Prince Charles as a coronavirus field hospital. In his remarks, Prince Charles stated, “Florence Nightingale, the lady with the lamp, brought hope and healing to thousands in their darkest hour. In this dark time this place will be a shining light” (9).

The Southwest Journal of Pulmonary and Critical Care congratulates and values the many legatees of Florence Nightingale in this 2020 International Year of the Nurse--the nurses and midwives across the globe for their unwavering dedication to education, research, practice and policy, as well as our valued interprofessional collaborations in promoting health and preventing disease.

References 

1. World Health Organization. Year of the Nurse and the Midwife 2020. Accessed 1 May 2020 from https://www.who.int/news-room/campaigns/year-of-the-nurse-and-the-midwife-2020
2. Jakel P. WHO’s International Year of the Nurse and Midwife. Accessed 1 May 2020 from https://www.oncnursingnews.com/publications/oncology-nurse/2020/april-2020/2020-whos-international-year-of-the-nurse-and-the-midwife
3. Beck DM, Dossey BM. In Nightingale's footsteps - individual to global: From nurse coaches to environmental and civil society activists. Creative Nursing: A Journal of Values, Issues, Experience and Collaboration, 2019;25(3):1-6.
4. Dossey BM, Rosa WE, Beck DM. Nursing and the sustainable development goals: From Nightingale to now. American Journal of Nursing, 2019;119(5):40-45. 
5. Bates, R. Florence Nightingale: A pioneer of handwashing and hygiene for health. Accessed 3 May 2020 from https://theconversation.com/florence-nightingale-a-pioneer-of-hand-washing-and-hygiene-for-health-134270
6. Columbia Mailman School of Public Health, Healthcare Policy. Florence Nightingale was an epidemiologist too. Accessed 4 May 2020 from https://www.mailman.columbia.edu/public-health-now/news/florence-nightingale-was-epidemiologist-too
7. Baldwin CM, Schultz AA, Barrere CC. (2016) ‘Evidence-based practice’, in Dossey BM & Keegan L., Holistic nursing: A handbook for practice. Burlington, MA: Jones & Bartlett, p. 639.
8. NHS England Website. Accessed 1 May 2020 from New NHS Nightingale Hospital To Fight Coronavirus
9. Evening Standard. NHS Nightingale officially opened by Prince Charles as coronavirus field hospital becomes world’s largest critical care unit. Accessed 2 May 2020 from https://www.standard.co.uk/news/health/nhs-nightingale-coronavirus-field-hospital-open-prince-charles-a4405796.html

2020 Año Internacional de la Enfermera y Partera y el Día Internacional de la Enfermera

Carol M. Baldwin, PhD, RN, CHTP, CT, AHN-BC, FAAN

Edson College of Nursing & Health Innovation

Arizona State University

Phoenix, AZ USA

Barbara M. Dossey, PhD, RN, AHN-BC, FAAN, HWNC-BC

Nightingale Initiative for Global Health (NIGH)

Washington, DC USA

La Organización Mundial de la Salud (OMS) designó 2020 como el Año Internacional de la Enfermera y la Partera para reconocer las contribuciones de las enfermeras y parteras en la promoción de la salud y el bienestar de las poblaciones de todo el mundo. Este reconocimiento está en concierto con el bicentenario del nacimiento de Florence Nightingale. Si bien las enfermeras y las parteras representan más de la mitad de la fuerza laboral mundial de atención de la salud, la OMS estima que en 2020 habrá una escasez de 9 millones de enfermeras (1,2). La Semana Internacional de Enfermeras comienza el 6 de mayo y culmina el 12 de mayo, Día Internacional de las Enfermeras, el aniversario del nacimiento de Nightingale con la esperanza de brindar un mayor reconocimiento a las enfermeras en la salud local y mundial.

Desafiando las normas victorianas esperadas para las mujeres nacidas de familias británicas acomodadas y bien conectadas a mediados del siglo XIX, Florence Nightingale eligió el arte y la ciencia de la enfermería en lugar del matrimonio. "Nightingale" es sinónimo de la base de la enfermería profesional, así como su servicio dedicado como gerente y formadora de enfermeras durante la Guerra de Crimea.

La influencia de Florence Nightingale, sin embargo, abarca mucho más que establecer una educación en enfermería. Medicina militar y de campo, epidemiología, hospitales prefabricados tempranos, supervisión hospitalaria, salud comunitaria y pública, política de salud, establecimiento de escuelas de enfermería y enfermerías, pioneros tempranos en el concepto de turismo médico, así como reforma social para las mujeres y todos los sectores de la sociedad se han beneficiado de sus logros innovadores. Su trabajo continúa. La Nightingale Initiative for Global Health (NIGH), por ejemplo, fomenta las actividades de Nightingale basadas en la justicia social y ambiental, la medicina preventiva y la salud holística desde el nivel local hasta el global (3,4).

Un observador entusiasta de las condiciones que conducen a la mala salud, Nightingale escribió ampliamente sobre la reforma sanitaria. Sus Notas sobre Enfermería enfatizaban el lavado frecuente de manos que presagiaba la higiene requerida durante la actual pandemia de Covid-19 (5). Nightingale fue la primera mujer admitida en la Sociedad Estadística de Londres (5). Se convirtió en miembro de la Asociación Americana de Estadística (6). Fue la primera enfermera para realizar y utilizar investigaciones. Nightingale demostró que los factores físicos y sociales influyeron en la salud, y que la calidad de la atención se puede mejorar mediante una cuidadosa recolección de datos, exhibiciones visuales que utilizaron su "diagrama de área polar" original, pensamiento crítico y práctica basada en evidencia (7).

El legado de Florence Nightingale perdura ante la pandemia de Covid-19. Se anunció el 24 de marzo de 2020 que el nuevo "Hospital Nightingale" se establecería en el centro de conferencias ExCel en el este de Londres para brindar apoyo a hasta 4,000 pacientes con Covid-19 (8). El 3 de abril de 2020, dentro de las dos semanas posteriores al anuncio, El “NHS Nightingale Hospital” fue inaugurado oficialmente por el Príncipe Carlos como un hospital de campaña de coronavirus. En sus comentarios, el Príncipe Carlos declaró: “Florence Nightingale, la dama de la lámpara, trajo esperanza y sanación a miles en su hora más oscura. En este tiempo oscuro este lugar será una luz brillante” (9).

The Southwest Journal of Pulmonary and Critical Care felicita y valora a los muchos legatarios de Florence Nightingale en este Año Internacional de la Enfermera 2020: las enfermeras y parteras de todo el mundo por su inquebrantable dedicación a la educación, la investigación, la práctica y la política, así como a nuestras valiosas colaboraciones interprofesionales en la promoción de la salud y la prevención de enfermedades.

Referencias

1. World Health Organization. Year of the Nurse and the Midwife 2020. Accessed 1 May 2020 from https://www.who.int/news-room/campaigns/year-of-the-nurse-and-the-midwife-2020
2. Jakel P. WHO’s International Year of the Nurse and Midwife. Accessed 1 May 2020 from https://www.oncnursingnews.com/publications/oncology-nurse/2020/april-2020/2020-whos-international-year-of-the-nurse-and-the-midwife
3. Beck DM, Dossey BM. In Nightingale's footsteps - individual to global: From nurse coaches to environmental and civil society activists. Creative Nursing: A Journal of Values, Issues, Experience and Collaboration, 2019;25(3):1-6.
4. Dossey BM, Rosa WE, Beck DM. Nursing and the sustainable development goals: From Nightingale to now. American Journal of Nursing, 2019;119(5):40-45. 
5. Bates, R. Florence Nightingale: A pioneer of handwashing and hygiene for health. Accessed 3 May 2020 from https://theconversation.com/florence-nightingale-a-pioneer-of-hand-washing-and-hygiene-for-health-134270
6. Columbia Mailman School of Public Health, Healthcare Policy. Florence Nightingale was an epidemiologist too. Accessed 4 May 2020 from https://www.mailman.columbia.edu/public-health-now/news/florence-nightingale-was-epidemiologist-too
7. Baldwin CM, Schultz AA, Barrere CC. (2016) ‘Evidence-based practice’, in Dossey BM & Keegan L., Holistic nursing: A handbook for practice. Burlington, MA: Jones & Bartlett, p. 639.
8. NHS England Website. Accessed 1 May 2020 from New NHS Nightingale Hospital To Fight Coronavirus
9. Evening Standard. NHS Nightingale officially opened by Prince Charles as coronavirus field hospital becomes world’s largest critical care unit. Accessed 2 May 2020 from https://www.standard.co.uk/news/health/nhs-nightingale-coronavirus-field-hospital-open-prince-charles-a4405796.html

Cite as: Baldwin CM, Dossey BM. 2020 international year of the nurse and midwife and international nurses’ day. Southwest J Pulm Crit Care. 2020;20(5):165-9. doi: https://doi.org/10.13175/swjpcc034-20 PDF

Who Should be Leading Healthcare for the COVID-19 Pandemic?

The recent COVID-19 pandemic brought to mind the Oscar Wilde quote, “An expert is an ordinary man away from home giving advice” (1). COVID-19 advice has flooded my inbox and dominated news coverage on television, in print and electronically. Everyone from the President to the hospital secretary seems to think they are qualified to offer advice on COVID-19 prevention and care. I admit to not being an expert on COVID-19 because I am not a virologist. However, despite retiring from the ICU in 2011, I think I know quite a bit about caring for sick patients with pneumonia having done it for over 30 years. For my part, and for many of my colleagues, the non-solicited, non-expert advice offered from these sources should be returned and the sender instructed to place it in that recess of the body most protected from sunlight.

The US government has not provided outstanding leadership during this pandemic. The President and CDC were both initially slow to respond and sometimes issued confusing or contradictory statements (2,3). Occasionally they were just wrong. The news media contributed to the confusion by reporting what was at times nonsense. All would be better off if we followed the guidance of someone like the NIH’s Dr. Tony Fauci who has said the right things while walking a political tightrope of gently contradicting the President.

Most hospitals have not done much better than the White House. I am overwhelmed with advice and sometimes pronouncements that claim to be evidence- or CDC-based. Sometimes they are-sometimes not. These are usually from a non- or minimally qualified administrator lacking medical expertise. We now hear reports that administrators are trying to direct health care providers not to wear personal protective equipment (PPE, masks, goggles, booties, etc.) in hallways or forbidding physicians and nurses from bringing their own PPE from home (4,5).

The hospitals give a variety of reasons for their actions, from conservation of PPE to the belief that it scares patients. Conservation of PPE is good idea. However, having someone change their mask every time they see a potential or a confirmed COVID-19 means using lots of masks while wearing one mask all day would help to conserve. Scaring patients is not good but unnecessarily exposing healthcare providers is worse. In Italy and Spain healthcare workers make up a disproportionately high number of cases (6-7). It is now thought that the hospital may be a primary source of infection and that the lack of doctors and nurses is impairing healthcare (6-8). Patients should be frightened and even more so when someone enters their room without a mask.

Although dealing with this crisis is the first priority, we need to ask ourselves at some point how could the US be so unprepared. We saw what a surge in ICU patients could do with the H1N1 influenza pandemic of 2009 leaving ICU beds and ventilators in short supply (9). In the 11 years since that time, the country did little to nothing. Where are the ventilators, the PPE and the medical personnel we now need?

Healthcare planning and emergency preparation have been done by non-medical people who now must take responsibility for our lack of preparedness. Those same people are now trying to direct care. They should back away and let those best able to deal with the present catastrophe provide the care. In the future we should ask what role they should play in planning for a National healthcare emergency. Will those planning be more concerned about allocating monies for future healthcare emergencies or another purpose? Perhaps we should have the planning done by those more knowledgeable and more concerned for the American people.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Guernsey L. Suddenly, everybody's an expert. NY Times. February 3, 2020. Available at: https://www.nytimes.com/2000/02/03/technology/suddenly-everybody-s-an-expert.html (accessed 3/27/20).
2. Edwards HS.  The Trump administration fumbled its initial response to coronavirus. Is there enough time to fix it? Time. March 19,2020. Available at: https://time.com/5805683/trump-administration-coronavirus/ (accessed 3/27/20).
3. Chen C, Allen M, Churchill L. Internal emails show how chaos at the CDC slowed the early response to coronavirus. ProPublica. March 26, 2020. Available at: https://www.propublica.org/article/internal-emails-show-how-chaos-at-the-cdc-slowed-the-early-response-to-coronavirus (accessed 3/27/20).
4. Ault A. Amid PPE shortage, clinicians face harassment, firing for self-care. Medscape. March 26, 2020. Available at: https://www.medscape.com/viewarticle/927590?nlid=134683_5461&src=wnl_dne_200327_mscpedit&uac=9273DT&impID=2325986&faf=1#vp_3 (accessed 3/27/20).
5. Whitman E. 'Taking masks off our faces': how Arizona hospitals are rationing protective gear. Available at: https://www.phoenixnewtimes.com/news/arizona-hospitals-rationing-masks-protective-gear-banner-11459400 (accessed 3/27/20).
6. Van Beusekom M. Doctors: COVID-19 pushing Italian ICUs toward collapse. Center for Infectious Disease Research and Policy, March 16, 2020. Available at: http://www.cidrap.umn.edu/news-perspective/2020/03/doctors-covid-19-pushing-italian-icus-toward-collapse (accessed 3/27/20).
7. Jones S. Spain: doctors struggle to cope as 514 die from coronavirus in a day. The Guardian. Available at: https://www.theguardian.com/world/2020/mar/24/spain-doctors-lack-protection-coronavirus-covid-19 (accessed 3/27/20).
8. Begley S. A plea from doctors in Italy: To avoid Covid-19 disaster, treat more patients at home. Stat. March 22, 2020. Available at: https://www.statnews.com/2020/03/21/coronavirus-plea-from-italy-treat-patients-at-home/ (accessed 3/27/20).
9. Levey NN, Christensen K, Phillips AM. A disaster foretold: Shortages of ventilators and other medical supplies have long been warned about. LA Times. March 20, 2020. Available at: https://www.latimes.com/politics/story/2020-03-20/disaster-foretold-shortages-ventilators-medical-supplies-warned-about (accessed 3/27/20).

Cite as: Robbins RA. Who should be leading healthcare for the COVID-19 pandemic? Southwest J Pulm Crit Care. 2020;20(3):103-4. doi: https://doi.org/10.13175/swjpcc021-20 PDF 

Why Complexity Persists in Medicine

This month’s Medical Image of the Month is a cartoon illustrating the complexity of medical billing (1). It illustrates that there are many people involved in the billing process who add nothing medically. However, they do add work, chaos and cost to both the provider and the patient. These along with other administrative costs are likely responsible for the largest portion of increasing healthcare expenses (2). Healthcare costs have far outpaced inflation and inflation adjusted reimbursement to providers has decreased (3,4). Costs of healthcare have become an increasing issue in political campaigns for both National parties. So why is no one doing anything about the issue? The truth is that some are benefitting from the complexity and have a financial incentive to maintain the status quo by opposing change.

The Centers for Medicare and Medicaid Services (CMS) and state Medicaids need to accept some of the responsibility for these cost increases. There has been a public sentiment doctors are overpaid, so actions taken by CMS and other government agencies have made physicians an easy target for policies that have led to instability in compensation. The declining income of private practice has led many physicians to flee to employed models (4). Not only has CMS contributed to driving physicians from self-employment by underpaying independent physicians but they have over compensated physician employed by hospitals. CMS estimates that it is now paying about $75 to $85 more on average for the same clinic visit in hospital outpatient settings compared to physician offices (5). Not surprisingly, these and other compensation disproportions have led to higher healthcare spending (6).

So, why does CMS rob the independent physicians to pay the hospitals and large healthcare organizations? An answer might be found in the recent actions regarding site-neutral payments. Many hospitals have bought physician and walk-in clinics to take advantage of the increased compensation from CMS and other insurance carriers. When the Trump administration proposed a “site-neutral” policy where payment would be lowered to hospitals and other healthcare organizations employing physicians, the American Hospital Association (AHA) and Association of American Medical Colleges (AAMC) sued (7). Government agencies are reluctant to challenge hospital, insurance or pharmaceutical companies and their lobbyists who are powerful and well-funded. This gives the appearance that it is much easier to be tough on independent physicians who are poorly organized, politically weak and not likely to sue.

Political tactics have been taken by the pharmaceutical companies who persuaded Congress not to allow US agencies such as CMS and the Department of Veterans Affairs to negotiate drug prices. It was in 2003, under then President George W. Bush, that Congress added a Part D benefit, through which CMS pays for seniors’ prescription drugs. The enactment followed a controversial House roll call vote, which was held open for several hours as House leaders maneuvered to secure enough votes for passage. One bargaining chip to attract votes from “market-oriented” Congressmen was the so-called “noninterference clause” which banned negotiations between CMS and pharmaceutical companies on drug prices and prevented the government from developing its own formulary or pricing structure. In other words, US Government agencies are forced to pay whatever prices the manufacturers set (8).

Sadly, our professional societies have also contributed to rising healthcare costs. An example is the Joint Commission which was formed in 1951 by merging the Hospital Standardization Program with similar programs run by the American College of Physicians, the American Hospital Association (AHA), the American Medical Association, and the Canadian Medical Association. However, the Joint Commission has become dominated the American Hospital Association which has continually pushed a hospital administrative agenda (9). Standards leading to or encouraging administrative efficiency appear nonexistent. Even our own professional societies have fixated on programs such as Choosing Wisely which emphasizes physicians not performing unnecessary testing or procedures. Although this is important for our patients, it is has not, nor is likely to, make any difference in healthcare costs.

All this is occurring at a time when the hospital-private practice physician partnership has largely dissolved. Hospitals want employed physicians because of the financial benefits of higher reimbursement but also because physicians as employees are much easier to control. As hospitals hire their own physicians, often in open competition with private practice physicians on their staff, the hospitals and private practice physicians are no longer partners but adversarial competitors. It is naïve to believe that hospitals will not take advantage of their position of power to eliminate the private practice competition or make changes to a system such as the complex reimbursement system which has benefited them so greatly. Even something so basic as stating the cost of a procedure has been vigorously opposed by the AHA (10). Similarly, the pharmaceutical industry has opposed transparency or government negotiation on drug prices (11). And why should the any of these healthcare administrators, pharmaceutical companies or insurance companies agree to any change? They are growing rich at the American public’s expense.

Rather than throwing up our hands in disgust or going to our windows, opening them and sticking our heads out to yell – “I'm as mad as hell and I'm not gonna take this anymore!” it is time to do something. However, as physicians we need to realize that we are weak and need help. First, we need to elect political candidates at all levels of government not based on their political affiliation but on their willingness to take action to curb healthcare costs. Second, if the politicians do not take action, we need to hold them accountable by voting for someone else. Third, we should lobby through our professional societies that administrative change needs to happen. If the societies will, we either need to serve in a society leadership role or change the leadership. Fourth, we need to oppose actions to further intrude into or control the practice of medicine at the local hospital level. For example, physician leaders are often chosen by the hospital administration not for their abilities by their amenability to a hospital administration’s agenda. As physicians we have let healthcare become controlled by greedy businessmen and correcting their intrusion into medical practice will be difficult. However, we should maintain hope, the alternative simply costs too much.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Umar A, Robbins RA. Medical image of the month: complexity of healthcare payment. Southwest J Pulm Crit Care. 2020;20(2):59. [CrossRef]
2. Robbins RA. National health expenditures: the past, present, future and solutions. Southwest J Pulm Crit Care. 2015;11(4):176-85. [CrossRef]
3. Kacik A. Rising prices drive estimated 6% medical cost inflation in 2020. Modern Healthcare. June 20, 2019. Available at: https://www.modernhealthcare.com/providers/rising-prices-drive-estimated-6-medical-cost-inflation-2020 (accessed 1/30/20).
4. Morris SS, Lusby H. The physician compensation bubble is looming. American Association of Physician Leadership. January 16, 2019. Available at: https://www.physicianleaders.org/news/physician-compensation-bubble-looming (accessed 1/30/20).
5. Dickson V. CMS slashes clinic visit payments, expands 340B cuts. Modern Healthcare. November 2, 2018. Available at: https://www.modernhealthcare.com/article/20181102/NEWS/181109978 (accessed 1/30/20).
6. Baker LC, Bundorf MK, Kessler DP. Vertical integration: hospital ownership of physician practices is associated with higher prices and spending. Health Aff (Millwood). 2014 May;33(5):756-63. [CrossRef] [PubMed]
7. Terry K. Court overturns CMS' site-neutral payment policy; doc groups upset. Medscape Medical News. September 19, 2019. Available at: https://www.medscape.com/viewarticle/918744?nlid=131645_5401&src=wnl_dne_190920_mscpedit&uac=9273DT&impID=2101100&faf=1#vp_2 (accessed 1/31/20).
8. Lee TL,  Gluck AR, Curfman GD. The politics of Medicare and drug-price negotiation (updated). Health Affairs Blog. September 19, 2016. Available at: https://www.healthaffairs.org/do/10.1377/hblog20160919.056632/full/ (accessed 1/31/20).
9. Gaul GM. Accreditors blamed for overlooking problems. Washington Post. 2005. Available at: https://www.washingtonpost.com/wp-dyn/content/article/2005/07/24/AR2005072401023.html (accessed 2/1/20).
10. Evans M. Hospitals turn to courts as lobbying fails to block price-transparency proposal. The Wall Street Journal. December 5, 2019. Available at: https://www.wsj.com/articles/hospitals-turn-to-courts-as-lobbying-fails-to-block-price-transparency-proposal-11575551412 (accessed 2/1/20).
11. Parramore LS. Prescription drug costs in Americans are sky-high. And yes, Big Pharma greed is to blame. NBC News. January 2, 2020. Available at: https://www.nbcnews.com/think/opinion/prescription-drug-costs-americans-are-sky-high-yes-big-pharma-ncna1109076 (accessed 2/1/20).

Cite as: Robbins RA. Why complexity persists in medicine. Southwest J Pulm Crit Care. 2020;20(2):60-2. doi: https://doi.org/10.13175/swjpcc006-20 PDF 

Fatiga de enfermeras, el sueño y la salud, y garantizar la seguridad del paciente y del publico: Unir dos idiomas

Carol M. Baldwin, PhD, RN, AHN-BC, FAAN

Edson College of Nursing & Health Innovation, PAHO/WHO Collaborating Centre to Advance the Policy on Research for Health, Arizona State University, Phoenix, AZ

Stuart F. Quan, MD, FAASM

Division of Sleep and Circadian Disorders, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; Asthma and Airways Research Center, University of Arizona, Tucson, AZ

Editor's Note: The following editorial is in both Spanish and English with the Spanish first. It refers to the article published in Spanish "Declaración de posición: Reducir la fatiga asociada con la deficiencia de sueño y las horas de trabajo en enfermeras". There is a link in the article to the original English version published in Nursing Oulook in 2017.

“Ahora ... tráeme ese horizonte” - Capitán Jack Sparrow

Estas palabras, pronunciadas por Capitán Jack Sparrow al final de Piratas del Caribe, presagian un nuevo comienzo, una aventura, un potencial en expansión. Así, también, con el Southwest Journal of Pulmonary and Critical Care. La revista está ampliando sus horizontes con la publicación de artículos de investigación y comentarios en español para desarrollar relaciones con investigadores de pulmón, cuidados críticos y sueño en todo el continente americano. Esta primera publicación en español, “Declaración de posición: reducir la fatiga asociada con la deficiencia de sueño y las horas de trabajo en enfermeras,” por Caruso y sus colegas, es una reimpresión traducida por los Centros para el Control y la Prevención de Enfermedades del Instituto Nacional de Seguridad y Salud Ocupacional (CDC NIOSH). Si bien el contenido es específico para las enfermeras, las implicaciones para la fatiga y la deficiencia del sueño son relevantes para otros proveedores de servicios de salud, personal de primera respuesta y profesiones y organizaciones adicionales que requieren turnos y horarios extendidos en todo el mundo. Dada la epidemia mundial de deficiencia de sueño, que es especialmente generalizada en las sociedades modernas, este documento debería ser un ejemplo para otras profesiones de la salud. (1) Se puede acceder a la versión en inglés de esta Declaración de posición en la cita a continuación. (2) La versión en español publicada en esta revista será la primera incursión en una "conversación" con nuestros colegas de habla hispana. Ahora ... ¡tráeme ese nuevo horizonte SWJPCC!

Referencias

1. Chattu VK, Sakhamuri SM, Kumar R, Spence DW, BaHammam AS, Pandi-Perumal SR. Insufficient Sleep Syndrome: Is it time to classify it as a major noncommunicable disease? Sleep Sci. 2018 Mar-Apr;11(2):56-64.
2. Caruso CC, Baldwin CM, Berger A, Chasens ER, Landis C, Redeker NS, et al. (2017). Position statement: Reducing fatigue associated with sleep deficiency and work hours in nurses. Nurs Outlook 2017;65:766-768.

Carol M. Baldwin y Stuart F. Quan desean reconocer a Gerardo (Jerry) González, Oficina de Relaciones con los Medios, Universidad Estatal de Arizona por su cuidadosa revisión y comentarios para la versión en español de este editorial.

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Nurse Fatigue, Sleep, and Health, and Ensuring Patient and Public Safety: Bringing Two Languages Together

Carol M. Baldwin, PhD, RN, AHN-BC, FAAN

Edson College of Nursing & Health Innovation, PAHO/WHO Collaborating Centre to Advance the Policy on Research for Health, Arizona State University, Phoenix, AZ

Stuart F. Quan, MD, FAASM

Division of Sleep and Circadian Disorders, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; Asthma and Airways Research Center, University of Arizona, Tucson, AZ

“Now... bring me that horizon” – Captain Jack Sparrow

These words, uttered by Captain Jack Sparrow at the close of Pirates of the Caribbean, presage a new beginning, an adventure, expanding potential. So, too, with the Southwest Journal of Pulmonary and Critical Care (SWJPCC). The journal is broadening its horizons with the publication of Spanish-language research and commentary articles to grow relationships with pulmonary, critical care and sleep researchers throughout the Americas. This first Spanish-language publication, “Position statement: Reducing fatigue associated with sleep deficiency and work hours in nurses,” by Caruso and colleagues is a reprint translated by the Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (CDC NIOSH). While the content is specific to nurses, the implications for fatigue and sleep deficiency are relevant to other health providers, first responders, professions and organizations that require shift work and extended shift hours across the globe. Given the worldwide epidemic of sleep deficiency, which is especially pervasive in modern societies, this document should be an exemplar for other health professions. (1) The English version of this Position Statement can be accessed at the citation below. (2) The Spanish version published in this journal will be the first foray into a ‘parley’ with our Spanish-speaking colleagues. Now... bring me that new SWJPCC horizon!

References

1. Chattu VK, Sakhamuri SM, Kumar R, Spence DW, BaHammam AS, Pandi-Perumal SR. Insufficient Sleep Syndrome: Is it time to classify it as a major noncommunicable disease? Sleep Sci. 2018 Mar-Apr;11(2):56-64.
2. Caruso CC, Baldwin CM, Berger A, Chasens ER, Landis C, Redeker NS, et al. (2017). Position statement: Reducing fatigue associated with sleep deficiency and work hours in nurses. Nurs Outlook 2017;65:766-768.

Carol M. Baldwin and Stuart F. Quan wish to respectfully acknowledge Gerardo (Jerry) Gonzalez, Office of Media Relations, Arizona State University for his careful review and comments for the Spanish-language version of this editorial.

Cite as: Baldwin CM, Quan SF. Fatiga de enfermeras, el sueño y la salud, y garantizar la seguridad del paciente y del publico: unir dos idiomas. Southwest J Pulm Crit Care. 2019;19:175-6. doi: https://doi.org/10.13175/swjpcc076-19 PDF 

CMS Rule Would Kick “Problematic” Doctors Out of Medicare/Medicaid

Last week CMS announced that beginning January 1, 2020, they assumed a new power to bar clinicians' participation if agency officials can cite potential harm to patients based on specific incidents (1). CMS created this new authority through the 2020 Medicare physician fee schedule. CMS claimed that it had no pathway to address "demonstrated cases of patient harm" in cases where clinicians maintain their licenses (2).

The rule drew criticism from multiple physician groups with none supporting it. The Alliance of Specialty Medicine said CMS has been using "vague and subjective" criteria to evaluate physicians for some time. The new revocation authority "just compounds the problem," the Alliance told Medscape Medical News (2).

In drafting the final version of the rule, CMS rejected many suggestions offered in comments about the revocation authority. The AMA pointed out that CMS hid such a major change in the annual physician fee schedule under the opioid treatment program section (2). The Association of American Medical Colleges (AAMC) said CMS should defer to state medical boards and other state oversight entities regarding issues associated with protecting beneficiaries from patient harm (2). In the final rule, CMS argued that it needs the new revocation authority due to cases where "problematic" behavior persists despite detection by state boards.

During the past week two examples of CMS’ bureaucratic nature were observed in my practice. First, I was told from a durable medical equipment provider that a new CMS requirement was that when reordering patient continuous positive airway pressure (CPAP) supplies that I would need to check, initial and date each item from a long list of supplies whether it was ordered or not. Second, an asthma patient was referred to me that was using daily albuterol. I recommended a long-acting beta agonist/corticosteroid combination but was told that the patient must fail corticosteroids alone before prescribing the more expensive combination therapy. Nearly every physician and many patients have seen some nameless and faceless clerk at CMS give them the “ol’ run around”. CMS’ argument that they are improving quality and protecting patients would be more believable if these and the many other instances of bureaucratic overreach were rare rather than common. 

Many “quality” programs have been thrust on clinicians in the past without any demonstrable improvement in healthcare for patients (3). Rather quickly these programs morph from a quality program to a hammer used to control clinicians and suppress dissent. In seems likely that CMS’ new self-assumed authority will be the same. If CMS wishes to improve care, they should deal with examples such as those above and many more instances of time wasting paper work and poor care that they mandate. Two recommendations to reduce these poor decisions are: 1. List the name of the licensed practitioner responsible for each CMS decision; and 2. Establish an efficient appeals process not controlled by CMS. These would reduce the instances of poor, anonymous decision makers hiding behind the anonymity of the CMS bureaucracy and could go a long way in improving patient care.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Centers for Medicare and Medicaid Services. November, 2019. Available at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-24086.pdf (accessed 11/9/19). Scheduled to be published in the Federal Register on 11/15/2019 and available online at https://federalregister.gov/d/2019-24086.
2. Young KD. CMS sharpens weapon to kick 'problematic' docs out of Medicare. Medscape Medical News. November 7, 2019. Available at: https://www.medscape.com/viewarticle/920994?nlid=132505_5461&src=wnl_dne_191108_mscpedit&uac=9273DT&impID=2159379&faf=1 (accessed 11/9/19).
3. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]

Cite as: Robbins RA. CMS rule would kick “problematic” doctors out of Medicare/Medicaid. Southwest J Pulm Crit Care. 2019;19(5):146-7. doi: https://doi.org/10.13175/swjpcc066-19 PDF 

Not-For-Profit Price Gouging

Kaiser Health News reports the case of Brianna Snitchler (1). She had a visible cyst on her abdomen which was biopsied using ultrasound as an outpatient at Henry Ford Health System’s main hospital. The cyst was found to be benign, but she received a $3,357.52 bill for her biopsy, ultrasound, lab tests and physician charges but the bill also included a $2,170 additional charge.

Although the initial bill from Henry Ford referred to “operating room services”, Ford later sent an itemized bill that referred to the charge for a treatment room in the radiology department. Both descriptions boil down to a facility fee, a common charge that has become controversial as hospitals search for additional streams of income, and as more patients complain to have been blindsided by these fees.

David Olejarz, manager of the media relations department of Henry Ford, said the “procedure was performed in the Interventional Radiology procedure room, where the imaging allows the biopsy to be much more precise. ...We perform procedures in the most appropriate venue to ensure the highest standards of patient quality and safety.” The need for a biopsy before removal of this cyst is questionable since the lesion had been present for years and had not changed. Furthermore, the need for the radiology procedure room and an ultrasound would seem superfluous since it could probably have been biopsied efficiently and safely in a physician’s office for considerably less money.

Ted Doolittle, with the Office of the Healthcare Advocate for Connecticut, called these facility fees “a black box” (1). In Connecticut hospitals are required to notify patients in advance about facility fees. Connecticut hospitals billed more than $1 billion in facility fees in 2015 and 2016, according to state records. Furthermore, Henry Ford would collect fees for every part of the procedure including the ultrasound, the lab tests, and probably the physician fees. Additionally, it is likely that the physician who referred Ms. Snitchler worked for Henry Ford and they would have collected a fee there, also.

Hospital officials argue that medical centers need the boosted income to provide the expensive care sick patients require, 24 hours a day, 365 days a year. However, Henry Ford Hospital already receives Medicaid disproportionate share (DSH) payments to help offset Henry Ford Hospital’s Medicaid shortfall because of its high portion of poor and Medicaid patients (2). Many “facility fees”, like Snitchler’s, are higher than would be considered reasonable or fair and are exploitative and unethical. In Snitchler’s case the facility fees nearly tripled the cost of the biopsy which despite having United Health Care insurance she will need to pay out of pocket. All this and she still has not had her cyst removed.

Hospitals appear to have solid finances. Although balance sheets are often inaccurate and misleading, most have greatly expanded their administrative personnel paying them record amounts (3). Henry Ford’s former CEO and trustee, Nancy Schlichting, was paid a salary or $4.77 million in 2016 (4). However, CEO salary is often only a portion of the total compensation with some tripling their salary through other compensation (3). Furthermore, Henry Ford lists page after page of administrative personnel which likely translates into hundreds of millions of dollars annually (5).

Henry Ford Health System was founded in 1915 by auto pioneer Henry Ford and is a leading health care provider for the poor in the Detroit area (6). Legislative action should be taken not only to notify patients of facility fees available prior to services but also to limit these fees to a reasonable amount of the total charges. The Centers for Medicare and Medicaid services could reexamine Henry Ford’s safety net designation or their tax-exempt not-for-profit status could be reexamined.

Henry Ford’s mission statement is, “We improve people's lives through excellence in the science and art of health care and healing” (6). However, as Henry Ford said, “Business must be run at a profit, else it will die. But when anyone tries to run a business solely for profit, then also the business must die, for it no longer has a reason for existence” (7). In this case, the Henry Ford Health System seems to be price gouging the poor rather than serving them. If profit is their sole goal, Henry Ford Hospital and medical centers like them have no reason to exist and are best left to perish.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Anthony C. Her biopsy report was benign. But the bill is a spot of contention. Kaiser Health News. September 30, 2019. Available at: https://khn.org/news/bill-of-the-month-facility-fees-biopsy-bill-september/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_source=hs_email&utm_medium=email&utm_content=77684052&_hsenc=p2ANqtz--ET6FHWzEGP_A7C5P7POEonKEpK9CvrI-71lI6WxyIZ1hwGzbaD0LxeJv0kE7B8vvPpZqCJsYWmtxxXeGIAt4tSW_tlg&_hsmi=77684052 (accessed 10/5/19).
2. MACPAC. Fact sheet: Henry Ford Hospital. March 2017. Available at: https://www.macpac.gov/wp-content/uploads/2017/03/Henry-Ford-Hospital.pdf (accessed 10/5/19).
3. Robbins RA. CEO compensation-one reason healthcare costs so much. Southwest J Pulm Crit Care. 2019;19(2):76-8. [CrossRef]
4. Welch S. Turnover, retirements factor in big changes in nonprofit compensation. Crain’s Detroit Business. May 20, 2017. Available at: https://www.crainsdetroit.com/article/20170521/news/628871/turnover-retirements-factor-big-changes-nonprofit-compensation (accessed 10/5/19)
5. Henry Ford Health System. Henry Ford Health System governance leadership. Available at: https://www.henryford.com/-/media/files/henry-ford/about/annual-reports/2017-system-report-leadership-listing.pdf (accessed 10/5/19).
6. Henry Ford Health System. About us. https://www.henryford.com/about (accessed 10/5/19).
7. AZ quotes. https://www.azquotes.com/quote/830473 (accessed 10/5/19).

Cite as: Robbins RA. Not-for-profit price gouging. Southwest J Pulm Crit Care. 2019;19(4):121-2. doi: https://doi.org/10.13175/swjpcc063-19 PDF 

Some Clinics Are More Equal than Others

In January the Centers for Medicare and Medicaid (CMS) site-neutral policy went into effect (1). Under this policy payments to some off-campus hospital clinics were reduced to those of private practice physicians. However, Judge Rosemary M. Collyer said in her decision, "The Court finds that CMS exceeded its statutory authority when it cut the payment rate for clinic services at off-campus provider-based clinics". According to her decision, in the Bipartisan Budget Act of 2015 Congress allowed hospitals to bill CMS at the higher outpatient department rate if they existed prior to Nov. 2, 2015.

This is how hospitals gamed the system. Hospitals acquire a doctor’s office or an emergency care clinic; hire salaried doctors to staff it; and raise the charges to what CMS would allow. They were able to do this because the doctor or practice was “grandfathered” and the fees are often 2-6 times the reimbursement for private physicians’ offices (2).

This ruling is consistent with a long-standing trend in Congress to restrict free market forces in healthcare. Congress has “squeezed” physicians to an extent that most have little choice but to work for hospitals. There has been a meteoric growth in hospital-employed physicians and hospital-owned physician practices. From July 2012 to July 2015, the number of hospital-employed physicians increased 49% (3). The number of hospital-owned physician practices increased by 31,000, which amounted to an 86% growth. Today more physicians are employed by hospitals than are in independent practices.

Also consistent with Congressional action to restrict free market forces has been its drug payment policy. CMS is forbidden from negotiating drug prices and is essentially forced to pay the price set by the pharmaceutical manufacturer. Private insurance companies follow CMS’ lead and pass these increased costs to the consumer.

Several bills have been introduced in Congress to curb drug pricing. The Congressional Budget Office has repeatedly stated that in order to decrease drug prices it is necessary to allow the federal government to negotiate prices (4). However, this is apparently a “socialist” act according to Senate Majority Leader, Mitch McConnell. McConnell has long been a supporter of the pharmaceutical companies and hospitals by doing nothing to alter the present system, and thus allowing hospitals and pharmaceutical companies to avoid free market forces, fix prices, and ensure maximal profits.

The Trump administration’s site neutral policy and allowing HHS to negotiate with pharmaceutical manufacturers are good policies that would likely lower healthcare costs and benefit patients. They are not “socialist” but instead attempt to restore to healthcare a free market economy that has long been missing. In George Orwell’s “Animal Farm” the pigs control the government and proclaim that “All animals are equal, but some animals are more equal than others”. The politicians who support inequitable reimbursement for the same healthcare service or allow pharmaceutical companies to overcharge for a drug are saying much the same.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Robbins RA. Court overturns CMS' site-neutral payment policy. Southwest J Pulm Crit Care. 2019;19(3):101-2. [CrossRef]
2. Carey MJ. Facility fees: the farce everyone pays for. Medical Economics. August 16, 2018. Available at: https://www.medicaleconomics.com/blog/facility-fees-farce-everyone-pays (accessed 9/19/19).
3. Cheney C. Hospital-physician consolidation growth trends moderate. Health Leaders February 28, 2019. Available at: https://www.healthleadersmedia.com/clinical-care/hospital-physician-consolidation-growth-trends-moderate (accessed 9/21/19).
4. Cubanski J, Neuman T, True S, Freed M. What’s the latest on Medicare drug price negotiations? Kaiser Family Foundation July 23, 2019. Available at: https://www.kff.org/medicare/issue-brief/whats-the-latest-on-medicare-drug-price-negotiations/ (accessed 9/21/19).

Cite as: Robbins RA. Some clinics are more equal than others. Southwest J Pulm Crit Care. 2019;19(3):103-4. doi: https://doi.org/10.13175/swjpcc61-19 PDF 

Blue Shield of California Announces Help for Independent Doctors-A Warning

An article today in Modern Healthcare announced that Blue Shield of California is launching a new program to help physician practices remain independent while giving them tools needed to succeed in value-based care arrangements (1). The program touts that it will offer independent doctors and practices tools to improve patient health outcomes while making it easier for them to focus on care instead of administrative tasks.

Blue Shield said it plans to support physicians in moving toward value-based care by investing in their practices. Investments could range from different types of affiliations to even employing the doctors in select situations. The announcement points out that independent physicians appear to be a dying breed. Furthermore, when independent physicians join an integrated healthcare system, costs increase (2).

On the surface this announcement sounds positive but the article raises a number of concerns. First, Blue Shield California is a for-profit company which had its not-for-profit status revoked by the state of California in 2014. Blue Shield California has also been known for being less than forthcoming with details regarding their business. Second, it is unclear what type of access Blue Shield plans to gain to physicians’ practices and patient files. Third, in many instances, quality measures have been nothing more than a series of meaningless metrics whose performance have not benefited patients. However, performance of these metrics has benefited healthcare executives’ bonuses.  Blue Cross and Blue Shield pays bonuses which on average are greater than 65% of the executive’s base salary. 20-25% of the bonuses are dependent on “quality” as defined by Blue Shield.

As with any dealings with insurance companies or integrated healthcare systems, physicians should be wary. What is the cost to patients and physicians? Will the company be charging for software installation and maintenance? What role will the insurance company have in determining value measures and what access will they have to patient data? Will any contractual agreement be easily canceled or will it be prolonged with the physician paying for the installation and use of any software? Will there be a noncompete clause forcing physicians to move if they decide to leave the agreement? These and other questions need to be addressed prior to any physicians signing on this or any similar agreements. Physicians considering any agreement or contract are encouraged to have them reviewed by lawyers familiar with healthcare to determine the potential pitfalls.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Livingston S.  Blue Shield of Calif. aims to help independent doctors with value-based care. Modern Healthcare. August 29, 2019. Available at: https://www.modernhealthcare.com/payment/blue-shield-calif-aims-help-independent-doctors-value-based-care (accessed 8/29/19).
2. Baker LC, Bundorf MK, Kessler DP. Vertical integration: hospital ownership of physician practices is associated with higher prices and spending. Health Aff (Millwood). 2014 May;33(5):756-63. [CrossRef] [PubMed]
3. Blue Shield of California. 2017 executive compensation summary. Available at: file:///C:/Users/Rick/Downloads/2017-Executive-Compensation-Summary-Final%20(1).pdf (accessed 8/29/19).

Cite as: Robbins RA. Blue Shield of California announces help for independent doctors-a warning. Southwest J Pulm Crit Care. 2019;19(2):85-6. doi: https://doi.org/10.13175/swjpcc058-19 PDF 

Medicare for All-Good Idea or Political Death?

Several Democratic presidential candidates have pushed the idea of “Medicare for All” and a “Medicare for All” bill has been introduced into the US house with over 100 sponsors. A recent Medpage Today editorial by Milton Packer asks whether this will benefit patients or physicians (1). Below are our views on “Medicare for All” with the caveat that we do not speak for the American Thoracic Society nor any of its chapters.

It has been repeatedly pointed out that medical care in the US costs too much. US health care spending grew 3.9 percent in 2017, reaching $3.5 trillion or $10,739 per person, and 17.9% of the gross domestic product (GDP) (2). This is more than any industrialized country. Furthermore, our expenditures continue to rise faster than most other comparable countries such as Japan, Germany, England, Australia and Canada (2).

Despite the high costs, the US does not provide access to healthcare for all of its citizens. In 2017, 8.8 percent of people, or 28.5 million, did not have health insurance at any point during the year (3). In contrast, other comparable industrialized countries provide at least some care for everyone.

Furthermore, our outcomes are worse. Infant mortality is higher than any similar country (4). US life expectancy is shorter at 78.6 years compared to just about any comparable industrialized company with Japan leading the way at 84.1 years. All the Western European countries (such as Germany, France, England, etc.), as well as Australia and Canada have a longer life expectancy than the US (range 81.8-83.7 years).

Our high infant mortality and lagging life expectancy was not always so. In 1980, the US had similar infant mortality and life expectancy when compared to other industrialized countries. Why did we lose ground over the last 40 years? Beginning in about 1980, there have been increasing business pressures on our healthcare system. In his editorial, Packer called our system "financialized" to an extreme (1). Hospitals, pharmaceutical and device companies, insurance companies, pharmacies and sadly,  even some physicians often price their products and services not according to what is fair or good for patients but to maximize profit. By incentivizing procedures that often do not benefit patients but benefit the businessmen’s’ pockets, these practices likely account for the high costs and for our worsening outcomes.

Packer points out that in the US, intermediaries (insurers and pharmacy benefit managers) exert considerable control of payment while unnecessarily adding to the administrative costs of healthcare. Congress has been pressured to forbid Medicare from negotiating prices with pharmaceutical companies benefitting only the drug manufacturers and those that benefit from the high drug prices. Consequently, administrative costs are four times higher and pharmaceuticals three times greater in the U.S. than in other countries.

If “Medicare for All” could reduce healthcare costs and improve outcomes, it might seem like a good idea. It has the potential for reducing administrative costs and assuming the power to negotiate drug prices was restored, pharmaceutical costs. However, it will be opposed by those who financially benefit from the present system including administrators, hospitals, pharmaceutical companies, pharmacy benefit managers, insurance companies, etc. Furthermore, there is a libertarian segment of the population that opposes any Government interference in healthcare, even those that would strengthen the free market principles that so many libertarians tout. There are already TV adds opposing “Medicare for All.” It seems likely that any “Medicare for All” or any similar plan will meet with considerable political opposition. 

One solution might be to have both Government and non-Government plans. Assuming transparency in both services covered and costs, it leaves the choice in healthcare plans where it belongs-with those paying for the care. It also makes it much harder for those with financial or political interests to convincingly argue against a Government plan (although we are sure they will try). It will force insurance companies to reduce their prices and/or offer more coverage, which is not a bad thing for patients and ultimately, the healthcare system as a whole. However, it does impose a risk, i.e., that profit-driven insurance companies and those who benefit from the current infrastructure will be  replaced by bureaucrats who are primarily concerned with administrative procedure rather than patient care. Present day examples include the VA, Medicare and Medicaid systems. Close public and medical oversight of such a system would be needed.

Ideally, a healthcare system should ensure that citizens can access at least a basic level of health services without incurring financial hardship and with the goal of improving health outcomes. Such a system, would provide a middle path between the extremes of paying for nothing and paying for everything such as unwarranted chemotherapy, stem cell therapy, or unnecessary diagnostic procedures. Determining what services are covered, and how much of the cost is covered are not easy questions to answer, but promises to deliver better health for less money than our current system. Physicians, by dint of their training, and responsibility to uphold their profession and protect their patients, understand that healthcare is not a mere commodity. If we are to protect what little autonomy we have left, we need to be a part of the discussion which should not be driven solely by those in the insurance, the hospital and the pharmaceutical industries.

Richard A. Robbins, MD¹

Angela C. Wang, MD²

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

²Scripps Clinic Torrey Pines, La Jolla, CA USA

References

1. Packer M. Medicare for All: Would Patients and Physicians Benefit or Lose? Medpage Today. July 10, 2019. Available at: https://www.medpagetoday.com/blogs/revolutionandrevelation/80926?xid=nl_mpt_blog2019-07-10&eun=g1127723d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Packer_071019&utm_term=NL_Gen_Int_Milton_Packer (accessed 7/10/19).
2. CMS. National Healthcare Expenditure Data. Available at: https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nationalhealthaccountshistorical.html (accessed 7/11/19).
3. Berchick ER, Hood E, Barnett JC. Health Insurance Coverage in the United States: 2017. September 12, 2018. United States Census Bureau Report Number P60-264. Available at: https://www.census.gov/library/publications/2018/demo/p60-264.html (accessed 7/11/19).
4. Gonzales S,  Sawyer  B.  How does infant mortality in the U.S. compare to other countries? Peterson-Kaiser Health System Tracker. July 7, 2017. Available at: https://www.healthsystemtracker.org/chart-collection/infant-mortality-u-s-compare-countries/#item-start (accessed 7/11/19).
5. Gonzales S, Ramirez M, Sawyer B.  How does U.S. life expectancy compare to other countries? Peterson-Kaiser Health System Tracker. April 4, 2019. Available at: https://www.healthsystemtracker.org/chart-collection/u-s-life-expectancy-compare-countries/#item-start (accessed 7/11/19).

Cite as: Robbins RA, Wang AC. Medicare for all-good idea or political death? Southwest J Pulm Crit Care. 2019;19(1):18-20. doi: https://doi.org/10.13175/swjpcc051-19 PDF

What Will Happen with the Generic Drug Companies’ Lawsuit: Lessons from the Tobacco Settlement

The State Attorney General of Connecticut, William Tong, has sued generic drug companies claiming they conspired to inflate prices and defraud the public of billions of dollars (1). To date, 43 state attorney generals have joined the suit. Tong, who takes doxycycline for rosacea, saw the price increase from $20 for 500 tablets in 2013 to $1,829 a year later. Although several generic companies sell doxycycline, one of the largest is Mylan. Both Mylan and their CEO, Heather Bresch, became infamous for the $10,000 EpiPen and a 4000% price hike in albuterol after testifying before the Senate Judiciary Committee in 2016 (2). The committee took no action and itself came under scrutiny when it was revealed that Mylan had made substantial campaign contributions to nearly all members of the committee (2).  Other companies named in this lawsuit include Teva, Sandoz, Pfizer and 16 other drug manufacturers. 

Now the states’ attorney generals, like knights on their shining armor, are rushing to protect the public from these “evil generic drug company price gougers.” The present suit is reminiscent of a prior generation of states’ attorney generals who 20 years ago filed and eventually settled a lawsuit against tobacco manufacturers for $206 billion (not a typo that is b as in billion) over 25 years (3). Based on that Tobacco Settlement we can predict what will happen with the generic drug company lawsuit. After legal wrangling for several years, a settlement of at least several billion will be reached. Payments will be placed in the states’ general funds. Like the tobacco companies, the drug companies will negotiate as a condition of the settlement to continue their business largely unregulated.

In 2007, the Government Accountability Office (GAO) reported that 22.9 % of proceeds from the Tobacco Settlement had gone to close state budget shortfalls, often to make up deficits caused by tax cuts (Figure 1) (3).

Figure 1. GAO analysis of categories to which states allocated their Tobacco Settlement payments (fiscal years 2000-2005) (3).

Another 7.1 percent had been spent on “general purposes” and another 6 percent on the politically popular term “infrastructure.”  Other notable highlights were that 11.9 percent of funds were “unallocated” and 7.8 percent had been devoted to “Other.”  Only about a third of the settlement revenues had been spent on health and tobacco control.

Much the same is likely to happen with the generic drug manufacturers lawsuit. A settlement will be reached and go into state funds and be viewed as a cash cow by legislators enthusiastic to cut taxes and/or fund their own pet projects. It seems likely that only a small portion will be spent on the public who for years have suffered inflated drug prices. After the settlement the generic manufacturers will be free to conduct business and fix prices as before.

If we can learn from the Tobacco Settlement, interventions can be taken to ensure the money is spent appropriately. States attorney generals should not be allowed to settle the suit benefiting those who were not harmed by unscrupulous price fixing. The spending of any settlement money should be supervised by the courts and the money should go directly to the state departments of health, away from tampering by state legislators and others. The money should be used to supplement healthcare for those who need the financial assistance the most. Since market forces regulating generic drug prices have apparently been corrupted, generic drug companies will need to have prices in the future approved assuring fair competition. Lastly, as a condition of settlement, CEOs need to sign agreements that impose severe penalties on both them and their companies for price fixing in the future.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Simmons-Duffin S. States sue drugmakers over alleged generic-price-fixing scheme. All Things Considered. NPR. May 13, 2019. Available at: https://www.npr.org/sections/health-shots/2019/05/13/722881642/states-sue-drugmakers-over-alleged-generic-price-fixing-scheme (accessed 5/14/19).
2. Pramuk J. Senators probing EpiPen price hike received donations from Mylan PAC. CNBC.  Aug 26, 2016. Available at: https://www.cnbc.com/2016/08/26/senators-probing-epipen-price-hike-received-donations-from-mylan-pac.html (accessed 5/14/19).
3. GAO. States’ allocations of payments from tobacco companies for fiscal years 2000 through 2005. US Government publication GAO-07-534T. February 27, 2007. Available at: https://www.gao.gov/assets/120/115580.pdf (accessed 5/14/19).

Cite as: Robbins RA. What will happen with the generic drug companies’ lawsuit: Lessons from the Tobacco Settlement. Southwest J Pulm Crit Care. 2019;18(6):155-6. doi: https://doi.org/10.13175/swjpcc032-19 PDF