By George C. Fareed, MD Brawley, California Michael M. Jacobs, MD, MPH Pensacola, Florida Donald C. Pompan, MD Salinas, California
August 12, 2020
Anthony Fauci, MD
National Institute of Allergy and Infectious Diseases
Dear Dr. Fauci:
You were placed into the most high-profile role regarding America’s response to the coronavirus pandemic. Americans have relied on your medical expertise concerning the wearing of masks, resuming employment, returning to school, and of course medical treatment.
You are largely unchallenged in terms of your medical opinions. You are the de facto “COVID-19 Czar." This is unusual in the medical profession in which doctors’ opinions are challenged by other physicians in the form of exchanges between doctors at hospitals, medical conferences, as well as debate in medical journals. You render your opinions unchallenged, without formal public opposition from physicians who passionately disagree with you. It is incontestable that the public is best served when opinions and policy are based on the prevailing evidence and science, and able to withstand the scrutiny of medical professionals.
As experience accrued in treating COVID-19 infections, physicians worldwide discovered that high-risk patients can be treated successfully as an outpatient, within the first five to seven days of the onset of symptoms, with a “cocktail” consisting of hydroxychloroquine, zinc, and azithromycin (or doxycycline). Multiple scholarly contributions to the literature detail the efficacy of the hydroxychloroquine-based combination treatment.
Dr. Harvey Risch, the renowned Yale epidemiologist, published an article in May 2020 in the American Journal of Epidemiology titled “Early Outpatient Treatment of Symptomatic, High-Risk COVID-19 Patients that Should be Ramped-Up Immediately as Key to Pandemic Crisis." He further published an article in Newsweek in July 2020 for the general public expressing the same conclusions and opinions. Dr. Risch is an expert at evaluating research data and study designs, publishing over 300 articles. Dr Risch’s assessment is that there is unequivocal evidence for the early and safe use of the “HCQ cocktail.” If there are Q-T interval concerns, doxycycline can be substituted for azithromycin as it has activity against RNA viruses without any cardiac effects.
Yet, you continue to reject the use of hydroxychloroquine, except in a hospital setting in the form of clinical trials, repeatedly emphasizing the lack of evidence supporting its use. Hydroxychloroquine, despite 65 years of use for malaria, and over 40 years for lupus and rheumatoid arthritis, with a well-established safety profile, has been deemed by you and the FDA as unsafe for use in the treatment of symptomatic COVID-19 infections. Your opinions have influenced the thinking of physicians and their patients, medical boards, state and federal agencies, pharmacists, hospitals, and just about everyone involved in medical decision making.
Indeed, your opinions impacted the health of Americans, and many aspects of our day-to-day lives including employment and school. Those of us who prescribe hydroxychloroquine, zinc, and azithromycin/doxycycline believe fervently that early outpatient use would save tens of thousands of lives and enable our country to dramatically alter the response to COVID-19. We advocate for an approach that will reduce fear and allow Americans to get their lives back.
We hope that our questions compel you to reconsider your current approach to COVID-19 infection.
QUESTIONS REGARDING EARLY OUTPATIENT TREATMENT:
(IT WOULD BE VERY HELPFUL TO HAVE THE GRAPHS COMPARING OUR CASE FATALITY RATES TO OTHER COUNTRIES.)
Since the start of the pandemic, physicians have used hydroxychloroquine to treat symptomatic COVID-19 infections, as well as for prophylaxis. Initial results were mixed as indications and doses were explored to maximize outcomes and minimize risks. What emerged was that hydroxychloroquine appeared to work best when coupled with azithromycin. In fact, it was the president of the United States who recommended to you publicly at the beginning of the pandemic, in early March, that you should consider early treatment with hydroxychloroquine and a “Z-Pack.” Additional studies showed that patients did not seem to benefit when COVID-19 infections were treated with hydroxychloroquine late in the course of the illness, typically in a hospital setting, but treatment was consistently effective, even in high-risk patients, when hydroxychloroquine was given in a “cocktail” with azithromycin and, critically, zinc in the first five to seven days after the onset of symptoms. The outcomes are, in fact, dramatic.
As clearly presented in the McCullough article from Baylor, and described by Dr. Vladimir Zelenko, the efficacy of the HCQ cocktail is based on the pharmacology of the hydroxychloroquine ionophore acting as the “gun” and zinc as the “bullet,” while azithromycin potentiates the anti-viral effect. Undeniably, the hydroxychloroquine combination treatment is supported by science. Yet, you continue to ignore the “science” behind the disease. Viral replication occurs rapidly in the first five to seven days of symptoms and can be treated at that point with the HCQ cocktail. Rather, your actions have denied patients treatment in that early stage. Without such treatment, some patients, especially those at high risk with co-morbidities, deteriorate and require hospitalization for evolving cytokine storm resulting in pneumonia, respiratory failure, and intubation with 50% mortality. Dismissal of the science results in bad medicine, and the outcome is over 160,000 dead Americans. Countries that have followed the science and treated the disease in the early stages have far better results, a fact that has been concealed from the American Public.
Despite mounting evidence and impassioned pleas from hundreds of frontline physicians, your position was and continues to be that randomized controlled trials (RCTs) have not shown there to be benefit. However, not a single randomized control trial has tested what is being recommended: use of the full cocktail (especially zinc), in high-risk patients, initiated within the first 5 to 7 days of the onset of symptoms. Using hydroxychloroquine and azithromycin late in the disease process, with or without zinc, does not produce the same, unequivocally positive results.
Dr. Thomas Frieden, in a 2017 New England Journal of Medicine article regarding randomized clinical trials, emphasized there are situations in which it is entirely appropriate to use other forms of evidence to scientifically validate a treatment. Such is the case during a pandemic that moves like a brushfire jumping to different parts of the country. Insisting on randomized clinical trials in the midst of a pandemic is simply foolish. Dr. Harvey Risch, a world-renowned Yale epidemiologist, analyzed all the data regarding the use of the hydroxychloroquine/HCQ cocktail and concluded that the evidence of its efficacy when used early in COVID-19 infection is unequivocal.
Curiously, despite a 65+ years safety record, the FDA suddenly deemed hydroxychloroquine a dangerous drug, especially with regard to cardiotoxicity. Dr. Risch analyzed data provided by the FDA and concluded that the risk of a significant cardiac event from hydroxychloroquine is extremely low, especially when compared to the mortality rate of COVID-19 patients with high-risk co-morbidities. How do you reconcile that for forty years rheumatoid arthritis and lupus patients have been treated over long periods, often for years, with hydroxychloroquine and now there are suddenly concerns about a 5 to 7-day course of hydroxychloroquine at similar or slightly increased doses? The FDA statement regarding hydroxychloroquine and cardiac risk is patently false and alarmingly misleading to physicians, pharmacists, patients, and other health professionals. The benefits of the early use of hydroxychloroquine to prevent hospitalization in high-risk patients with COVID-19 infection far outweigh the risks. Physicians are not able to obtain the medication for their patients, and in some cases are restricted by their state from prescribing hydroxychloroquine. The government’s obstruction of the early treatment of symptomatic high-risk COVID-19 patients with hydroxychloroquine, a medication used extensively and safely for so long, is unprecedented.
It is essential that you tell the truth to the American public regarding the safety and efficacy of the hydroxychloroquine/HCQ cocktail. The government must protect and facilitate the sacred and revered physician-patient relationship by permitting physicians to treat their patients. Governmental obfuscation and obstruction are as lethal as cytokine storm.
Americans must not continue to die unnecessarily. Adults must resume employment and our youth return to school. Locking down America while awaiting an imperfect vaccine has done far more damage to Americans than the coronavirus. We are confident that thousands of lives would be saved with early treatment of high-risk individuals with a cocktail of hydroxychloroquine, zinc, and azithromycin. Americans must not live in fear. As Dr. Harvey Risch’s Newsweek article declares, “The key to defeating COVID-19 already exists. We need to start using it.”
George C. Fareed, MD
Michael M. Jacobs, MD, MPH
Donald C. Pompan, MD
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