by George Parry – Aug 17, 2020 – for The American Spectator
My cmnt: I’ve edited the questions down quite a bit for space. The full column is here – I recommend that you read all of the questions in the full letter. They are devastating to Fauci’s absurd position on HCQ. He has quite simply become a political hack for the democrats.
As you may be aware, health-care providers across the country and around the world have reported great success in using Hydroxychloroquine + Zinc + Azithromycin (the “HCQ cocktail”) to treat COVID-19. According to these physicians and researchers, the key to success is to use the HCQ cocktail within the first seven days after onset of COVID-19 symptoms.
Nevertheless, ever since President Trump endorsed Hydroxychloroquine (HCQ), its use has become a highly politicized and controversial matter. The opposition to HCQ started with Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. At the same press conference that the president first expressed hope about using HCQ to treat COVID-19, Dr. Fauci challenged its effectiveness and stated that he would not take it outside the confines of a clinical trial.
Since then the opposition to HCQ has increased even to the point where it is almost impossible to find physicians willing to prescribe it and pharmacies willing to provide it.
Three practicing physicians have published the following “Open letter to Dr. Anthony Fauci regarding the use of Hydroxychloroquine for treating COVID-19.” It is a devastating written cross-examination of Dr. Fauci that contains much valuable life-saving information and squarely addresses the needless deaths that have occurred due to the opposition to the HCQ cocktail.
When the history of the COVID-19 pandemic is written, one of the key issues will be why the United States’ medical and government establishments joined forces to deprive the American people access to a safe, inexpensive, and highly effective outpatient treatment that could have saved tens of thousands lives and definitively obliterated the purported justification for the social and economic lockdowns that have destroyed lives, livelihoods, and the economy.
So, here’s the article. Although it is lengthy, I urge you to read it carefully and share it with one and all. Lives, livelihoods, the economy and our very social fabric remain at risk.
Open letter to Dr. Anthony Fauci regarding the use of Hydroxychloroquine for treating COVID-19
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:
There are generally two stages of COVID-19 symptomatic infection; initial flu like symptoms with progression to cytokine storm and respiratory failure, correct? When people are admitted to a hospital, they generally are in worse condition, correct? There are no specific medications currently recommended for early outpatient treatment of symptomatic COVID-19 infection, correct? Remdesivir and Dexamethasone are used for hospitalized patients, correct? There is currently no recommended pharmacologic early outpatient treatment for individuals in the flu stage of the illness, correct? It is true that COVID-19 is much more lethal than the flu for high-risk individuals such as older patients and those with significant comorbidities, correct? Individuals with signs of early COVID-19 infection typically have a runny nose, fever, cough, shortness of breath, loss of smell, etc., and physicians send them home to rest, eat chicken soup etc., but offer no specific, targeted medications, correct? These high-risk individuals are at high risk of death, on the order of 15 percent or higher, correct? So just so we are clear — the current standard of care now is to send clinically stable symptomatic patients home, “with a wait and see” approach? Are you aware that physicians are successfully using Hydroxychloroquine combined with Zinc and Azithromycin as a “cocktail” for early outpatient treatment of symptomatic, high-risk, individuals?
QUESTIONS REGARDING SAFETY:
The FDA writes the following: “In light of on-going serious cardiac adverse events and their serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for authorized use.” So not only is the FDA saying that hydroxychloroquine doesn’t work, they are also saying that it is a very dangerous drug. Yet, is it not true the drug has been used as an anti-malarial drug for over 65 years? Isn’t it true that the drug has been used for lupus and rheumatoid arthritis for many years at similar doses? Do you know of even a single study prior to COVID-19 that has provided definitive evidence against the use of the drug based on safety concerns? Are you aware that chloroquine or hydroxychloroquine has many approved uses for hydroxychloroquine including steroid-dependent asthma (1988 study), advanced pulmonary sarcoidosis (1988 study), sensitizing breast cancer cells for chemotherapy (2012 study), the attenuation of renal ischemia (2018 study), lupus nephritis (2006 study), epithelial ovarian cancer (2020 study), just to name a few? Where are the cardiotoxicity concerns ever mentioned? Risch estimates the risk of cardiac death from hydroxychloroquine to be 9/100,000 using the data provided by the FDA. That does not seem to be a high risk, considering the risk of death in an older patient with co-morbidities can be 15 percent or more. Do you consider 9/100,000 to be a high risk when weighed against the risk of death in older patient with co-morbidities? To put this in perspective, the drug is used for 65 years, without warnings (aside for the need for periodic retinal checks), but the FDA somehow feels the need to send out an alert on June 15, that the drug is dangerous. Does that make any logical sense to you Dr. Fauci based on “science”? Moreover, consider that the protocols for usage in early treatment are for five to seven days at relatively low doses of hydroxychloroquine similar to what is being given in other diseases (RA, SLE) over many years — does it make any sense to you logically that a five to seven day dose of hydroxychloroquine when not given in high doses could be considered dangerous? You are also aware that articles published in the New England Journal of Medicine and Lancet, one out of Harvard University, regarding the dangers of hydroxychloroquine had to be retracted based on the fact that the data was fabricated. Are you aware of that? If there was such good data on the risks of hydroxychloroquine, one would not have to use fake data, correct?
QUESTIONS REGARDING METHODOLOGY:
In regards to the use of hydroxychloroquine, you have repeatedly made the same statement: “The Overwhelming Evidence from Properly Conducted Randomized Clinical Trials Indicate no Therapeutic Efficacy of Hydroxychloroquine.” Is that correct? In Dr. Risch’s article regarding the early use of hydroxychloroquine, he disputes your opinion. He scientifically evaluated the data from the studies to support his opinions. Have you published any articles to support your opinions? You repeatedly state that randomized clinical trials are needed to make conclusions regarding treatments, correct? The FDA has approved many medications (especially in the area of cancer treatment) without randomized clinical trials, correct? Are you aware that Dr. Thomas Frieden, the previous head of the CDC, wrote an article in the New England Journal of Medicine in 2017 called “Evidence for Health Decision Making — Beyond Randomized Clinical Trials (RCT)?” Have you read that article? In it Dr. Frieden states that “many data sources can provide valid evidence for clinical and public health action, including analysis of aggregate clinical or epidemiological data.” Do you disagree with that? Frieden discusses “practiced-based evidence” as being essential in many discoveries, such SIDS (Sudden Infant Death Syndrome). Do you disagree with that? Frieden writes the following: “Current evidence-grading systems are biased toward randomized clinical trials, which may lead to inadequate consideration of non-RCT data.” Dr. Fauci, have you considered all the non-RCT data in coming to your opinions? Risch, who is a leading world authority in the analysis of aggregate clinical data, has done a rigorous analysis that he published regarding the early treatment of COVID-19 with hydroxychloroquine, zinc, and azithromycin. He cites five or six studies, and in an updated article there are five or six more, a total of 10 to 12 clinical studies with formally collected data specifically regarding the early treatment of COVID. Have you analyzed the aggregate data regarding early treatment of high-risk patients with hydroxychloroquine, zinc, and azithromycin? Is there any document that you can produce for the American people of your analysis of the aggregate data that would rebut Dr. Risch’s analysis? Yet, despite what Dr. Risch believes is overwhelming evidence in support of the early use of hydroxychloroquine, you dismiss the treatment insisting on randomized controlled trials even in the midst of a pandemic?
COMPARISON BETWEEN U.S. AND OTHER COUNTRIES REGARDING CASE FATALITY RATE:
- Are you aware that countries like Senegal and Nigeria that use hydroxychloroquine have much lower case-fatality rates than the United States?
- Have you pondered the relationship between the use of hydroxychloroquine by a given country and their case mortality rate and why there is a strong correlation between the use of HCQ and the reduction of the case mortality rate.?
- Have you considered consulting with a country such as India that has had great success treating COVID-19 prophylactically?
- Why shouldn’t our first responders and front-line workers who are at high risk at least have an option of HCQ/zinc prophylaxis?
- We should all agree that countries with far inferior healthcare delivery systems should not have lower case fatality rates. Reducing our case fatality rate from near 5 percent, to 2.5 percent, in line with many countries who use HCQ early would have cut our total number of deaths in half, correct?
- Why not consult with countries who have lower case-fatality rates, even without expensive medicines such as remdesivir and far less advanced intensive care capabilities?
GIVING AMERICANS THE OPTION TO USE HCQ FOR COVID-19:
Harvey Risch, the pre-eminent epidemiologist from Yale, wrote a Newsweek article titled: “The key to defeating COVID-19 already exists. We need to start using it.” Did you read the article? Are you aware that the cost of the hydroxychloroquine “cocktail” including the Z-pack and zinc is about $50? You are aware the cost of remdesivir is about $3,200? So that’s about 60 doses of HCQ “cocktail,” correct? In fact, President Trump had the foresight to amass 60 million doses of hydroxychloroquine, and yet you continue to stand in the way of doctors who want to use that medication for their infected patients, correct? Those are a lot of doses of medication that potentially could be used to treat our poor, especially our minority populations and people of color that have a difficult time accessing healthcare. They die more frequently of COVID-19, do they not? But because of your obstinance blocking the use of HCQ, this stockpile has remained largely unused, correct? Would you acknowledge that your strategy of telling Americans to restrict their behavior, wear masks, and distance, and put their lives on hold indefinitely until there is a vaccine is not working? So, 160,000 deaths later, an economy in shambles, kids out of school, suicides and drug overdoses at a record high, people neglected and dying from other medical conditions, and America reacting to every outbreak with another lockdown — is it not time to re-think your strategy that is fully dependent on an effective vaccine? Why not consider a strategy that protects the most vulnerable and allows Americans back to living their lives and not wait for a vaccine panacea that may never come?
Fauci, please explain how a randomized clinical trial, to which you repeatedly make reference, for testing the HCQ cocktail (hydroxychloroquine, azithromycin, and zinc) administered within five to seven days of the onset of symptoms is even possible now given the declining case numbers in so many states? For example, if the NIH were now to direct a study to begin September 15, where would such a study be done? Please explain how a randomized study on the early treatment (within the first five to seven days of symptoms) of high-risk, symptomatic COVID-19 infections could be done during the influenza season and be valid? Please explain how multiple observational studies arrive at the same outcomes using the same formulation of hydroxychloroquine + azithromycin + zinc given in the same time frame for the same study population (high risk patients) is not evidence that the cocktail works? In fact, how is it not significant evidence, during a pandemic, for hundreds of non-academic private practice physicians to achieve the same outcomes with the early use of the HCQ cocktail?
While previous questions are related to hydroxychloroquine-based treatment, we have two questions addressing masks.
- As you recall, you stated on March 8, just a few weeks before the devastation in the Northeast, that masks weren’t needed. You later said that you made this statement to prevent a hoarding of masks that would disrupt availability to healthcare workers. Why did you not make a recommendation for people to wear any face covering to protect themselves, as we are doing now?
- Rather, you issued no such warning and people were riding in subways and visiting their relatives in nursing homes without any face covering. Currently, your position is that face coverings are essential. Please explain whether or not you made a mistake in early March, and how would you go about it differently now.
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