A group of prominent researchers and physicians, some of whom regulatory participate as TrialSite contributors, recently had a paper published in Medical Hypothesis titled “Early Multidrug Treatment of SARS-CoV-2 Infection (COVID-19) and Reduced Mortality Among Nursing Home Residents,” emphasizing the importance of early treatment outcomes in nursing home settings. In North America, as well as elsewhere, the wrath of this pandemic has bestowed death upon the elderly at horrific levels as the pathogen’s progression manifests more intensely in the elderly with accelerated viral replication and disease progression, including cytokine storm and endothelial injury with thrombosis. The Center for Disease Control and Prevention (CDC) acknowledges the severity of COVID-19 risk associated with age alone. For example, 8 out of 10 COVID-19 deaths in America are among the elderly 65 years of age and up. Many of those deaths occurred in long-term care (nursing homes) both in America and Canada, where in the latter instance, observers have referred to the situation as a “national disgrace.” Although there are some exceptions in America where early-stage treatment involving off-label ivermectin or hydroxychloroquine for example were administered, few of our elderly were given any therapeutic care upon onset of the SARS-CoV-2 infection because the health authorities haven’t accepted any data from existing studies. Rather, they opted to invest billions of public taxpayer dollars in vaccine development in addition to highly experimental therapeutics, such as monoclonal antibody therapies with narrow prescription pathways. But these prestigious investigators, including Drs. Peter McCullough, Paul Alexander, Robin Armstrong, Howard Risch, George Fareed, and Howard Tenenbaum as well as others, report some positive data with multi-therapy strategies that led to a greater than 60% reduction in mortality. Why don’t the broader media platforms share this information with the public? What follows is a summary of the study and an extensive contribution by one of its authors, Dr. Paul E. Alexander from McMaster University.
These doctors have believed strongly in their obligation, the Hippocratic Oath, to put the patient above all else, above politics, money, and scientific fights. But unfortunately, society isn’t so kind or sensitive to such an ethos. The battle for repurposing of existing drugs in combination for antiviral regimen to help reduce the death rates has felt like an all-out war, a David and Goliath story where these doctors, David, took on a giant establishment fueled by money, power, and prestige.
While dedicating considerable time to patients, many of these physicians and researchers worked around the clock, studying, researching, and ultimately, reporting on their findings. In this case, they found specifically nine actual studies or case reports of situations where nursing home staff used a multi-drug therapy including hydroxychloroquine with one or more anti-infectives, corticosteroids and antithrombotic agents to treat seniors in a nursing home setting without hospitalization as reported recently in the journal Medical Hypothesis.
Based on the results that these multi-drug therapies reduced the mortality rate for high risk elderly by over 60%, the researchers suggest that “early empiric treatment for the elderly with COVID-19 in the nursing home setting (or similar congregated settings with elderly residents/patients) has a reasonable probability of success and acceptable safety.”
A Passionate, Committed and Dedicated Expert
Dr. Alexander, one of the lead authors, spent time working at WHO/PAHO as a consultant for COVID-19 as well as a senior advisor at U.S. Health and Human Services (HHS) in the previous Trump administration and brought to the study extensive training in epidemiology, evidence-based medicine, and research methodology out of the University of Toronto, Oxford, and McMaster University.
TrialSite was able to engage with Dr. Alexander in regards to this recently published paper. He admits that he himself did not truly understand the full benefits of early outpatient treatment until he was mentored and studied aggressively under leaders in this early treatment approach. He states, “to really understand what was happening and appreciate the benefits in reducing hospitalization and death for vulnerable COVID positive persons, one has to read and listen to and be part of the mindset of pioneers such as Dr. Harvey Risch, Dr. Peter McCullough, Dr. Vladimir Zelenko, and Dr. Pierre Kory. The reality is that SARS-CoV-2 and resulting COVID-19 illness has spread across the globe and has caused widespread hospitalization and death. Whether you are in the more affluent western nations of the United States and Canada to the lesser advantaged and resourced nations of the Caribbean islands where I was born. “
The COVID-19 Danger Zone
Dr. Alexander told TrialSite that “The good news is that COVID spares our children unlike influenza, but it is savage to elderly high-risk persons and even younger but high-risk persons including those who are obese. While it was the economic benefits and prospects I saw delivered under the Trump administration for minorities that allowed me to agree to serve as the pandemic emerged, I was dismayed by the burden of deaths in the nursing homes, long-term care facilities, and assisted-living facilities (congregated settings). I was particularly aware of the vicious morbidity and mortality that accrued for minorities and those of lower SES in these congregated settings due to COVID and saw the heavy burden on African-Americans and minorities and the failure of the public health agencies (past administration and current one) to stem the deaths.”
Something Had to be Done
The Canada-based researcher continued:
“I just could not understand it and became very outraged when I learnt more of the benefits of simple, cost-effective, available, and safe treatments that were already in use for other conditions for decades (drugs that could be used effectively as anti-virals to arrest the viral replication early on so that COVID does not progress to the hyper-immune dysregulated pulmonary/ARDS ‘cytokine’ phase). A sequenced combination of antiviral therapy, immunomodulation, and antiplatelet/antithrombotic therapy, in the backdrop of nutraceuticals such as vitamins D and C. I learnt personally of the treatment success from hundreds of doctors treating tens of thousands of patients in the US and globally and it shocked me how effective early treatment was and I thought we got to have this everywhere to save lives.”
A Failure to Follow the Hippocratic Oath
He shared with TrialSite a justifiable anger directed at the medical establishment and doctors, seemingly lacking the courage nor trusting their clinical instincts, and not exercising their clinical judgement and discretion to treat their high-risk persons, rather sending them home to ‘wait and see’ as they worsened in place. Dr. Alexander pointed out, “I have spoken to many clinicians who have told me that they are scared of the heavy impact on their careers if they are treated early, that their research grants would be cut off and their positions cut in the academic institution or hospital etc. This is reprehensible that good doctors are treated this way as they try to do the best for their patients. The reality is that people’s lungs fail not because the virus is there, but because blood clots are there and with early treatment, we can save lives to prevent the end-stage sequelae.”
Treatment Early On is Key But Authoritarian-like Pressure
According to Dr. Alexander, doctors have a two-week window with COVID whereby once they intervened early in the sequelae (in the initial viral replication phase of COVID’s three phases) when symptoms initially begin (when the person is in their home setting or nursing home type-setting), they could dramatically reduce the risk of hospitalization and death (as much as 85 to 90%) yet their hands are tied by bureaucracies and licenses threatened if they use the early treatment and in his terms, this is “outrageous.” Suggesting, “Why let someone wait for two weeks to worsen in their home or in the nursing home, when you can dramatically improve their chances of survival by using early cheap, safe, and effective drugs that are available already and approved? Something other than science continues at play here.”
At-Risk Populations Include Underserved, Underrepresented
Simple public service information, such as the need to manage body weight and daily supplements of vitamin D, were absent and continue to be, and this could have saved lives in the minority populations who are deficient in a vitamin that is critical to the function of their immune systems, Dr. Alexander shared with the TrialSite. He believes the lack of this offering represents a complete tragedy. The researcher suggests that government agencies from the FDA to the NIH have tied the hands of the doctors who cannot practice medicine as they should, advocating a position of ‘no treatment’ unless a patient is hospitalized and in need of oxygen. He emphasized, “This is a catastrophic failure in leadership for this is often too late for many. This is immoral and apprehensive when lives could be saved, and especially for minority populations that have borne the heavier burden of death from COVID, this uneven burden seen also in nursing homes.”
“I know that the rapidity and highly communicable nature of the SARS-CoV-2 has constrained the design and execution of definitive randomized, controlled trials of therapy outside of the clinic or hospital. But this was and is an emergency and in the absence of clinical trial results, physicians must use what has been learned about the pathophysiology of SARS-CoV-2 infection in determining early outpatient treatment of the illness with the aim of preventing hospitalization or death.”
In calling for the proper empowerment of physicians, Alexander emphasized, “They must use their clinical judgement and rely also on ‘real-world’ evidence and trust themselves. Be brave. We know that future randomized trials testing out the principles and therapeutics (antivirals and combination approaches etc.) will undoubtedly refine, clarify, and validate their individual or combined roles. Yet we emphasize the immediate need for treatment when the patient is scared, confused, and there is extensive hospital resource consumption, morbidity, and mortality. Patients die lonely agonizing deaths in-hospital away and isolated from families and we can prevent hospitalization in the first place, let alone death. It is absolutely imperative that doctors do all they can to save their patient and early treatment with drugs such as ivermectin and hydroxychloroquine with corticosteroids and anti-clotting drugs gives their patient a way better chance of survival than doing nothing”.
As reported in Medical Hypothesis, the researcher’s implications should be read and understood by those in influential positions in government, academia, and the health sector including physicians and include “1) hospitalizations and deaths would be reduced 2) transmission would be reduced due to the mitigation of symptoms and 3) recovery following infection and treatment provides for natural exposure immunity that is broad, durable, and robust (helping towards natural immunity in the population).”
What could be a different outcome than what actually occurred, an ending with at least less strain on hospital systems, from big tertiary institutions to community hospitals giving way for the care of other, non-COVID imminent problems, from cancer and autoimmune disease to chronic cardiovascular, diabetes and central nervous system-based diseases. Not to mention the saving of possibly hundreds of thousands of lives of the elderly.