September 08, 2020

From the ER to the High School Football Field, People Want the Response to Covid-19 to Be Evidence-based, not Political



To date, the FDA has only approved a single therapeutic (Remdesivir) specifically for Covid-19—and that drug is, according to many, of questionable benefit. In situations where approved therapeutic options are lacking, health care providers typically draw on their knowledge of comparable ailments, their problem-solving skills and their prior experience using solidly vetted therapies and approaches from the medical toolkit. In fact, the FDA encourages them to do so, suggesting that health care providers engage in off-label prescribing (the prescription of a drug for a non-FDA-approved use) “when they judge that it is medically appropriate for their patient.” In the U.S., an estimated 12% to 38% of doctors’ prescriptions are for off-label uses. Although this practice has the potential for abuse, the president of the American College of Physicians says, “Just because something is an off-label use doesn’t mean it doesn’t work. And it doesn’t mean it’s inappropriate.”

The issue of off-label prescribing has come up repeatedly for Covid-19 and was touched on indirectly in a mid-August interview between movie actor Matthew McConaughey and Anthony Fauci, who came together on social media in what one news report characterized as a warm and fuzzy “happy hour celebration of science, certainty and teamwork.” McConaughey asked for Fauci’s opinion about two remedies reported as helpful for some Covid-19 patients: zinc supplements and budesonide, an inhaled steroid that some physicians have prescribed to help distressed Covid-19 patients breathe. Fauci was instantly negative about both, stating that many things “work in the test tube but don’t work in the body” and suggesting that, at best, the two remedies might occasionally be associated with a placebo effect.

… concluded that systemic corticosteroids such as dexamethasone reduce the risk of death in critically ill Covid-19 patients by 20%.

Clinical trials say otherwise

Fauci’s dismissive comments were somewhat surprising, given that the doctor’s agency, the National Institutes of Health (NIH), currently lists 26 studies involving zinc and 7 studies involving budesonide in its clinical trials database. Patented in 1973, budesonide was commercialized for asthma in the early 1980s and has been used uncontroversially and worldwide ever since. The World Health Organization (WHO) includes budesonide on its List of Essential Medicines.

Five countries are dedicating time and resources to the study of budesonide for Covid-19. These include France (with two trials), the UK, Spain, Iran and the U.S. itself, including one study in which the NIH is a partner. As Dr. Fauci likely also knows, over two dozen Covid-19 clinical trials have been completed or are underway focusing on another inexpensive steroid called dexamethasone.

On September 2, news outlets around the world shared the dramatic results of a meta-analysis of seven clinical trials, carried out by a WHO working group and published in the Journal of the American Medical Association (JAMA), which concluded that systemic corticosteroids such as dexamethasone reduce the risk of death in critically ill Covid-19 patients by 20%. A British researcher involved in the meta-analysis noted that the results were remarkably consistent across the seven countries (one being the U.S.), “showing the drugs were beneficial in the sickest patients regardless of age or sex or how long patients had been ill.” Another researcher stated, “These results are clear, and instantly usable in clinical practice.” The WHO has updated its treatment guidance accordingly.

Even before the release of these results, a number of nations—whether hit hard by Covid-19 or not—had already approved dexamethasone specifically as a Covid-19 treatment, including Taiwan (with just seven coronavirus deaths in a population of 24 million), Japan, the UK, Kuwait, Saudi Arabia and South Africa.

… proactive early use of nebulized budesonide, taken in combination with the antibiotic clarithromycin, produced favorable results

The earlier, the better

As a novel medical condition, Covid-19 presents novel challenges to clinicians working in emergency rooms (ERs). In this setting, doctors’ and nurses’ immediate responsibility is to assess how best to stabilize their patients. However, in addition to using measures that are helpful in the short term, physicians caring for Covid-19 patients also recognize the need to try to forestall a potential downhill slide into a “cytokine storm,” a syndrome where the immune system goes rogue. This phenomenon has been a hallmark of some severe Covid-19 cases.

Soon after Covid-19 emerged, Dr. Richard Bartlett, a Texas-based ER physician and trauma expert, found numerous mentions of budesonide in the scientific literature, which described budesonide as a promising antiviral and anti-inflammatory drug to address similar viruses such as rhinoviruses and other coronaviruses. Budesonide, though not entirely side-effect-free, also has the reputation of working in a targeted manner that is less likely to produce the types of total-body side effects encountered with systemic corticosteroids—effects such as anxiety, insomnia, decreased muscle mass, bone loss, impaired wound healing and reduced immune response.

In symptomatic Covid-19 patients, Dr. Bartlett found that proactive early use of nebulized budesonide, taken in combination with the antibiotic clarithromycin, produced favorable results—ameliorating symptoms, shortening illness duration and keeping cytokine storm reactions from taking hold. In a case study co-authored with nursing expert Alexandria Watkins, DNP-APRN, Bartlett described successful outcomes in two Covid-19 patients who also happened to have multiple serious comorbidities (including lymphoma, hypertension, hypothyroidism, type 2 diabetes and gout). In August, a powerhouse group of 23 authors from Yale and other top U.S. universities as well as Italy published a paper that endorsed early use of corticosteroids and other interventions indicated for ambulatory patients; more broadly, the group emphasized the importance of early outpatient treatment for preventing hospitalizations and death.

In Canada, 57% of 15- to 17-year-olds recently rated their mental health as “somewhat worse” or “much worse” than before physical distancing began.

Let’s not forget the children

During the McConaughey-Fauci interview, the Hollywood actor expressed “rage” at Covid-19’s politicization but declined to put Dr. Fauci on the spot, even though Fauci’s confusing double standards about potential Covid-19 therapies—and his obvious bias in favor of vaccines—have helped propagate mistrust and polarization. Fauci’s messages have been similarly polarizing where children and school reopenings are concerned. In mid-May, he castigated Senator Rand Paul for suggesting that schools should reopen. In the August chat with McConaughey, the stern implications of Fauci’s remarks were that schools cannot reopen without continued lockdown measures: “You wanna open the bars, or you wanna open the schools?”

Ignoring this flippancy, many concerned researchers and health care providers are speaking up about the adverse effects that lockdown and social distancing measures are having on children, particularly given that those age 14 and under represent 0.035% of all deaths recorded as involving Covid-19 (57/164,280 as of August 22). In Canada, 57% of 15- to 17-year-olds recently rated their mental health as “somewhat worse” or “much worse” than before physical distancing began. In the U.S., the verdict has been even blunter, with experts warning that a significant number of children are suffering from post-traumatic stress disorder (PTSD). According to a summary of this assessment in Newsweek, “The impact of school closures, increased time away from their peers and worries about their health [is] not only likely to impact [children] in the short term but also [will] have ‘longer-term consequences for their mental health’ even after the immediate COVID-19 pandemic.”

Just as health care providers are growing frustrated with having their hands tied in hospitals and clinics, many children and parents have had enough, arguing for the reopening of in-person instruction and especially for the renewal of extracurricular activities such as sports. For Fauci—who says “for goodness sakes, stay away from crowds”—sports present a “fundamental problem of gathering people together.” For a growing number of kids and parents, however, gathering together is the heart of the matter. As a Dallas teen poignantly explained at a peaceful protest against school and sports closures in late August, “extracurriculars are what make the heart of the school. Without the heart, I don’t think you can operate.”

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