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 5 to 7 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% 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?
- Have you heard of the “Zelenko Protocol,” for treating high-risk patients with COVID 19 as an outpatient?
- Have you read Dr. Risch’s article in the American Journal of Epidemiology of the early outpatient treatment of COVID-19?
- Are you aware that physicians using the medication combination or “cocktail” recommend use within the first 5 to 7 days of the onset of symptoms, before the illness impacts the lungs, or cytokine storm evolves?
- Again, to be clear, your recommendation is no pharmacologic treatment as an outpatient for the flu—like symptoms in patients that are stable, regardless of their risk factors, correct?
- Would you advocate for early pharmacologic outpatient treatment of symptomatic COVID-19 patients if you were confident that it was beneficial?
- Are you aware that there are hundreds of physicians in the United States and thousands across the globe who have had dramatic success treating high-risk individuals as outpatients with this “cocktail?”
- Are you aware that there are at least 10 studies demonstrating the efficacy of early outpatient treatment with the Hydroxychloroquine cocktail for high-risk patients — so this is beyond anecdotal, correct?
- If one of your loved ones had diabetes or asthma, or any potentially complicating comorbidity, and tested positive for COVID-19, would you recommend “wait and see how they do” and go to the hospital if symptoms progress?
- Even with multiple studies documenting remarkable outpatient efficacy and safety of the Hydroxychloroquine “cocktail,” you believe the risks of the medication combination outweigh the benefits?
- Is it true that with regard to Hydroxychloroquine and treatment of COVID-19 infection, you have said repeatedly that “The Overwhelming Evidence of Properly Conducted Randomized Clinical Trials Indicate No Therapeutic Efficacy of Hydroxychloroquine (HCQ)?”
- But NONE of the randomized controlled trials to which you refer were done in the first 5 to 7 days after the onset of symptoms- correct?
- All of the randomized controlled trials to which you refer were done on hospitalized patients, correct?
- Hospitalized patients are typically sicker that outpatients, correct?
- None of the randomized controlled trials to which you refer used the full cocktail consisting of Hydroxychloroquine, Zinc, and Azithromycin, correct?
- While the University of Minnesota study is referred to as disproving the cocktail, the meds were not given within the first 5 to 7 days of illness, the test group was not high risk (death rates were 3%), and no zinc was given, correct?
- Again, for clarity, the trials upon which you base your opinion regarding the efficacy of Hydroxychloroquine, assessed neither the full cocktail (to include Zinc + Azithromycin or doxycycline) nor administered treatment within the first 5 to 7 days of symptoms, nor focused on the high-risk group, correct?
- Therefore, you have no basis to conclude that the Hydroxychloroquine cocktail when used early in the outpatient setting, within the first 5 to 7 days of symptoms, in high risk patients, is not effective, correct?
- It is thus false and misleading to say that the effective and safe use of Hydroxychloroquine, Zinc, and Azithromycin has been “debunked,” correct? How could it be “debunked” if there is not a single study that contradicts its use?
- Should it not be an absolute priority for the NIH and CDC to look at ways to treat Americans with symptomatic COVID-19 infections early to prevent disease progression?
- The SARS-CoV-2/COVID-19 virus is an RNA virus. It is well-established that Zinc interferes with RNA viral replication, correct?
- Moreover, is it not true that hydroxychloroquine facilitates the entry of zinc into the cell, is a “ionophore,” correct?
- Isn’t also it true that Azithromycin has established anti-viral properties?
- Are you aware of the paper from Baylor by Dr. McCullough et. al. describing established mechanisms by which the components of the “HCQ cocktail” exert anti-viral effects?
- So- the use of hydroxychloroquine, azithromycin (or doxycycline) and zinc, the “HCQ cocktail,” is based on science, correct?
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 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% 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, 2020 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 5 to 7 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 5 to 7 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?
- After all, 65 years is a long-time to determine whether or not a drug is safe, do you agree?
- In the clinical trials that you have referenced (e.g., the Minnesota and the Brazil studies), there was not a single death attributed directly to hydroxychloroquine, correct?
- According to Dr. Risch, there is no evidence based on the data to conclude that hydroxychloroquine is a dangerous drug. Are you aware of any published report that rebuts Dr. Risch’s findings?
- Are you aware that the FDA ruling along with your statements have led to Governors in a number of states to restrict the use of hydroxychloroquine?
- Are you aware that pharmacies are not filling prescriptions for this medication based on your and the FDA’s restrictions?
- Are you aware that doctors are being punished by state medical boards for prescribing the medication based on your comments as well as the FDA’s?
- Are you aware that people who want the medication sometimes need to call physicians in other states pleading for it?
- And yet you opined in March that while people were dying at the rate of 10,000 patient a week, hydroxychloroquine could only be used in an inpatient setting as part of a clinical trial- correct?
- So, people who want to be treated in that critical 5-to-7-day period and avoid being hospitalized are basically out of luck in your view, correct?
- So, again, for clarity, without a shred of evidence that the Hydroxychloroquine/HCQ cocktail is dangerous in the doses currently recommend for early outpatient treatment, you and the FDA have made it very difficult if not impossible in some cases to get this treatment, 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 5 or 6 studies, and in an updated article there are 5 or 6 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?
- Would you want a loved one with high-risk comorbidities placed in the control group of a randomized clinical trial when a number of studies demonstrate safety and dramatic efficacy of the early use of the Hydroxychloroquine “cocktail?”
- Are you aware that the FDA approved a number of cancer chemotherapy drugs without randomized control trials based solely on epidemiological evidence. The trials came later as confirmation. Are you aware of that?
- You are well aware that there were no randomized clinical trials in the case of penicillin that saved thousands of lives in World War II? Was not this in the best interest of our soldiers?
- You would agree that many lives were saved with the use of cancer drugs and penicillin that were used before any randomized clinical trials–correct?
- You have referred to evidence for hydroxychloroquine as “anecdotal”- which is defined as “evidence collected in a casual or informal manner and relying heavily or entirely on personal testimony”- correct?
- But there are many studies supporting the use of hydroxychloroquine in which evidence was collected formally and not on personal testimony, has there not been?
- So it would be false to conclude that the evidence supporting the early use of hydroxychloroquine is anecdotal, correct?
Comparison between the US and other countries regarding case fatality rate
(It would be very helpful to have the graphs comparing our case fatality rates to other countries)
- 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% to 2.5%, 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 neglecting 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?
- Why not consider the approach that thousands of doctors around the world are using, supported by a number of studies in the literature, with early outpatient treatment of high-risk patients for typically one week with HCQ + Zinc + Azithromycin?
- You don’t see a problem with the fact that the government, due to your position, in some cases interferes with the choice of using HCQ. Should not that be a choice between the doctor and the patient?
- While some doctors may not want to use the drug, should not doctors who believe that it is indicated be able to offer it to their patients?
- Are you aware that doctors who are publicly advocating for such a strategy with the early use of the HCQ cocktail are being silenced with removal of content on the internet and even censorship in the medical community?
- You are aware of the 20 or so physicians who came to the Supreme Court steps advocating for the early use of the Hydroxychloroquine cocktail.In fact, you said these were “a bunch of people spouting out something that isn’t true.”Dr. Fauci, these are not just “people”- these are doctors who actually treat patients, unlike you, correct?
- Do you know that the video they made went viral with 17 million views in just a few hours, and was then removed from the internet?
- Are you aware that their website, American Frontline Doctors, was taken down the next day?
- Did you see the way that Nigerian immigrant physician, Dr. Stella Immanuel, was mocked in the media for her religious views and called a “witch doctor”?
- Are you aware that Dr. Simone Gold, the leader of the group, was fired from her job as an Emergency Room physician the following day?
- Are you aware that physicians advocating for this treatment that has by now probably saved millions of lives around the globe are harassed by local health departments, state agencies and medical boards, and even at their own hospitals? Are you aware of that?
- Don’t you think doctors should have the right to speak out on behalf of their patients without the threat of retribution?
- Are you aware that videos and other educational information are removed off the internet and labeled, in the words of Mark Zuckerberg, as “misinformation.”?
- Is it not misinformation to characterize Hydroxychloroquine, in the doses used for early outpatient treatment of COVID-19 infections, as a dangerous drug?
- Is it not misleading for you to repeatedly state to the American public that randomized clinical trials are the sole source of information to confirm the efficacy of a treatment?
- Was it not misinformation when on CNN you cited the Lancet study based on false data from Surgisphere as evidence of the lack of efficacy of hydroxychloroquine?
- Is it not misinformation as is repeated in the MSM as a result of your comments that a randomized clinical trial is required by the FDA for a drug approval?
- Don’t you realize how much damage this falsehood perpetuates?
- How is it not misinformation for you and the FDA to keep telling the American public that hydroxychloroquine is dangerous when you know that there is nothing more than anecdotal evidence of that?
- Fauci, if you or a loved one were infected with COVID-19, and had flu-like symptoms, and you knew as you do now that there is a safe and effective cocktail that you could take to prevent worsening and the possibility of hospitalization, can you honestly tell us that you would refuse the medication?
- Why not give our healthcare workers and first responders, who even with the necessary PPE are contracting the virus at a 3 to 4 times greater rate than the general public, the right to choose along with their doctor if they want use the medicine prophylactically?
- Why is the government inserting itself in a way that is unprecedented in regard to a historically safe medication and not allowing patients the right to choose along with their doctor?
- Why not give the American people the right to decide along with their physician whether or not they want outpatient treatment in the first 5 to 7 days of the disease with a cocktail that is safe and costs around $50?
- 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 5-7 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 5 to 7 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?
- What is your recommendation for the medical management of a 75-year-old diabetic with fever, cough, and loss of smell, but not yet hypoxic, who Emergency Room providers do not feel warrants admission? We know that hundreds of U.S. physicians (and thousands more around the world) would manage this case with the HCQ cocktail with predictable success.
- If you were in charge in 1940, would you have advised the mass production of penicillin based primarily on lab evidence and one case series on 5 patients in England or would you have stated that a randomized clinical trial was needed?
- Why would any physician put their medical license, professional reputation, and job on the line to recommend the HCQ cocktail (that does not make them any money) unless they knew the treatment could significantly help their patient?
- Why would a physician take the medication themselves and prescribe it to family members (for treatment or prophylaxis) unless they felt strongly that the medication was beneficial?
- How is it informed and ethical medical practice to allow a COVID-19 patient to deteriorate in the early stages of the infection when there is inexpensive, safe, and dramatically effective treatment with the HCQ cocktail, which the science indicates interferes with coronavirus replication?
- How is your approach to “wait and see” in the early stages of COVID-19 infection, especially in high-risk patients, following the science?
While previous questions are related to hydroxychloroquine-based treatment, we have two questions addressing masks.
- As you recall, you stated on March 8th, 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 5 to 7 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 5 to 7 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.