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

By the Children’s Health Defense Team

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.

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.

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 […]

Via https://childrenshealthdefense.org/news/from-the-er-to-the-high-school-football-field-people-want-the-response-to-covid-19-to-be-evidence-based-not-political/

© 8 Sept 2020 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.