Pictured: Left – Dr. George Fareed; Center – Dr. Darell DeMello; Right – Dr. Fernando Valerio
Real Clear Investigations:
For the first nine months of the COVID-19 pandemic, there were no officially approved outpatient treatments for combating the disease. From March 2020, when the virus first emerged in the United States, until that November, when the Food and Drug Administration authorized emergency use of monoclonal antibodies, health authorities advised that the infected do little but quarantine themselves, drink plenty of fluids and rest unless hospitalization was necessary.
During those chaotic final months of Donald Trump’s presidency, the medical establishment expressed extreme caution regarding outpatient treatments for the virus, and these warnings were amplified by major media hostile to the president.
Although an estimated 12% to 38% of prescriptions are written for FDA-approved drugs used “off-label” (including Botox and Viagra), Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, declared early on that providers should dispense only medicines proven to be safe and effective for COVID patients through “randomized, placebo-controlled trials.” These can take months or years to conduct, and often at great cost.
Given the time involved, some governments and independent practitioners considered that standard a recipe for inaction that meant likely death for untold numbers of victims. These medical dissenters instead treated COVID-19 as physicians have long responded to newly emerging infectious diseases: by administering designer cocktails of cheap, safe and readily available agents – in this case including hydroxychloroquine, antibiotics, aspirin, and vitamins – that had proven effective in treating similar illnesses or otherwise demonstrated theoretical promise due to mechanisms of action.
Dr. Brian Tyson, a primary care physician and former hospital intensivist in Imperial County, Calif., who has championed outpatient treatment, explained the calculation: “If I’m wrong with the treatment I’m giving, people are still going to die. If I’m right, how many lives have we saved? How many can be saved? Why are we erring on the side of death instead of treatment?”
RealClearInvestigations spoke or corresponded with 12 such advocates for early outpatient treatment globally — from California, Texas and Honduras to France, Israel and India. Their track record appears to challenge the prevailing official clinical guidance under which more than 500,000 Americans, among nearly 3 million globally, died from the pandemic in its first year ending March 2021. These physicians used their years of clinical experience to make educated guesses about what combinations of drugs might work. Few used the same cocktail; there is no consensus about which drugs worked best, though some were adamant about the benefits of specific agents; but all insisted the treatments proved most effective when administered as early as possible in the course of illness. Although the efficacy of the cocktails has not been verified in clinical trials – which could rigorously account for myriad factors including the age, weight, gender, medical history and level of illness of patients – all report that their improvised efforts improved care without doing harm.
The dissenters became proactive early on, among them:
- Dr. George Fareed, an Imperial, Calif.-based former National Institutes of Health virology researcher and Harvard Medical School grad who with his primary care colleague, Dr. Tyson, reports an early outpatient treatment track record of 7,000 COVID patients with only seven deaths.
- Dr. Fernando Valerio, a former Dartmouth trainee who came to national prominence in Honduras for pioneering inpatient and outpatient protocols eventually implemented nationwide. As one of only four intensive-care doctors in San Pedro Sula, a city of 1.2 million, he quickly ruled out a hospitalization-heavy approach as impractical. Instead, he prodded the government to send medical providers door-to-door in virus hotspots to distribute at-home drug kits. And Honduras’ mortality rate declined markedly – to roughly half that of the United States at current count.
- Dr. Darrell DeMello in Mumbai, India, who has treated patients, including employees of some of the world’s largest multinational firms, with a drug regimen similar to Dr. Fareed’s, and with similar results. Out of an estimated 7,500 patients, he reports, he has lost 16.
Their work raises hard questions about what the responsible practice of medicine should look like when there are no approved medical treatments in the face of likely widespread death. Could there have been more and earlier life-saving innovation before the pharmaceutical industry’s remarkable development much later of vaccines and novel therapeutics? Is trying something better than doing nothing until lengthy clinical trials are completed? Or, especially when the risks of “fake news” and its viral spread are high, do the demands of providing authoritatively endorsed treatments override all?
Researchers knew fairly early in the pandemic that COVID infections progressed through several stages marked by specific symptoms treatable with a slew of safe, FDA-approved medications.
For example, it was known in March 2020 that the illness progressed from a viral phase to massive inflammation across the body. Anti-inflammatory drugs – such as colchicine, the choice of Dr. DeMello in Mumbai – could have been administered at clinicians’ discretion.
By June 2020 it was known that COVID could cause major blood clotting. The blood thinner Plavix, another choice of Dr. DeMello, is commonly used to prevent and treat clotting. As Dr. Tyson explained, if patients are “showing inflammatory changes, let’s use an anti-inflammatory. We see people getting clots, dying of coronary artery clogs, let’s use a blood thinner.”