Opinion: RBG vs ACB - A Tolkien Analogy

"Of course my story is not an allegory of Atomic power, but of Power."

The Letters of J.R.R. Tolkien #186

Well, here we are in another Supreme Court confirmation death-match.  Yay!  It’s so great to see our leaders behaving in such a rational and fair manner.  It makes me feel all warm and fuzzy inside!  (Oh wait, that’s nausea. Never mind.)

Last time it was Brett Kavanaugh’s turn in the hot seat.  Democrats went so far as to accuse this highly respected accomplished lawyer and family man of serial gang rape!  I couldn’t believe what I was seeing.  It defied explanation.   

And Kavanaugh was just the latest.  This slimy Kabuki theater has played-out every single time a conservative justice has been named, but never when liberal ones are.  Why is that?  And what could possibly turn these seemingly normal looking Democrat Senators into such vile sub-humans? 

I found my answer in the pages of J. R. R. Tolkien. 

If you’ll recall, "The Lord of The Rings" is a story that revolves around the fate of a certain magical ring in a fantasy world known as Middle Earth.  Though there were twenty of these rings forged, the story is about one ring that has power over all the others.  Whoever possesses it has super-powers like immortality, invisibility, and under certain circumstances, totalitarian power over Middle Earth.  But there’s a serious downside to bearing the ring; so intoxicating and addictive is its power, it can transform its weaker owners into unrecognizable, twisted, slimy, deranged, creatures. 

And that’s exactly what happens when it comes to the absolute power of the courts.  The essential challenge for anyone who wears a black robe is to subordinate their personal agenda to a document written over two hundred years ago.  That's the  job of a Justice under our system. It takes an extraordinary amount of self restraint to put the original intent of the U.S. Constitution above one's own politics.  Moreover, just like the ring that grants immortality, Justices serve as long as they can breathe.  Even Presidents don’t have that kind of power for that long.

Imagine how intoxicating, tempting, and corrupting that power can be for a Justice, or for a Senator involved in confirmation?  Don’t like a law or policy?  Just change it at the court!  All you need is five like minded Justices and you have totalitarian power over all social, economic, and political policy in the U.S..   No need to go through the icky time-consuming process of passing laws or amending the Constitution.  Just have the right people put on a robe, wave a magic pen, and voila!  Imagine how much strength of character one would need to resist that temptation?  Imagine having the magic ring in your pocket and resisting its allure out of fealty to our founding principles?

Democrats long ago realized they needed the courts for their agenda to succeed.  And what is that agenda?  It’s often referred to as “progressivism”, which translates to progressively more power to the government, going well beyond what the Constitution envisioned.  Ask yourself this, have you ever seen a Democrat proposal that didn’t grow the power and scope of the federal government?  I don’t think you have.  Certainly not under Obama.  Have a problem with student loans?  Nationalize them!  Have a problem with healthcare?  Nationalize it!  Have a problem with education? Nationalize it under something called Common Core!  Have a problem with the internet?  Nationalize it under something called Net Neutrality!  And this list could go on for pages.  

The problem with all that nationalization is that a) everything becomes politicized, and b) everything ends-up at the Supreme Court.  The courts become the sine qua non for the agenda's success.  But the real problem in the long run is that if you take this progressive power grab out to its logical conclusion, it ends in totalitarian government.  

So just like the one ring, the Supreme Court is the key that opens the door to infinite power.    

Which takes us to the current situation in which Ruth Bader Ginsburg is being replaced by Amy Coney Barrett.       

RBG was certainly beloved by her fans.  Women of all stripes looked up to her as a role model.  No doubt she was a tiny person who left a big mark.  She’s been lauded as a champion for social justice, women’s rights, LGBTQ rights, the downtrodden, etc.  And many called her courageous.  Similarly, ACB looks to be another beloved, courageous, female role model who promises to leave a big mark. Yet among the people who worshipped RBG, she is considered a pariah.   That’s because unlike RBG, ACB is expected to be a champion for only one thing - the U.S. Constitution.    

We call these two judicial approaches liberal/progressive vs. conservative, or activist vs. originalist.  But what they really represent are two perspectives of the Constitution.  One side sees the Constitution as an obstacle to progress, and the other sees it as the limiting principle that makes us exceptional. Justices are granted the magical power to either abide by the Constitution or ignore it.  There’s no penalty for ignoring it, and no reward for abiding by it.  Sorry RBG fans, it takes no courage for a Justice to ignore the Constitution.  The only courage involved is in resisting the siren song of totalitarian power. 

Did you ever wonder why so-called Conservative judges often start out that way and then transform into activist or progressive ones?  Recent cases include the current Chief Justice, John Roberts, who has single-handedly re-written major laws to advance his agenda. And have you ever noticed that it never goes the other way?  Activist judges never eschew their power and turn originalist.  There are many ways temptation and power can corrupt an individual.  But self restraint can only result from strong character and courage, and that's either present or it's not.  

So why does a Justice like RBG sail through confirmation with bipartisan support including almost every Republican, while the equally qualified Brett Kavanaugh doesn’t get any Democrat support?  Why does it always go that way and not the other?  Democrats need the courts in a way Republicans do not.  They have pinned their hopes on subverting the limits laid out in the Constitution, and that can only be done with activist judges.  Republicans are either oblivious or ambivalent to this strategy.  

So why did RBG stay on the court knowing she had cancer?  Why not retire while Obama was President and have him name a successor?  Recall that Tolkien’s character Smeagol starts out as a mild mannered Hobbit, but is corrupted by the ring’s power into the twisted, slimy, deranged creature called Gollum. That metamorphosis is the same one that affects Democrats who embrace the corrupting power of activist courts.  One can picture RBG in her later years mumbling to herself:

With John Roberts and even Neil Gorsuch and Brett Kavanaugh as unknown quantities, it’s safe to say that ACB will not be a “fires of Mount Doom” event for the activist Supreme Court.  The Constitution will never be safe.  It will always take tremendous self restraint, strong character, and courage to hold this Republic together.  The enemies of constitutionally limited government will never rest.

For now, the best we can hope for is that ACB is confirmed, has the courage of Frodo, and never transforms into Gollum.  

An Open Letter to Dr. Fauci

August 12, 2020

Anthony Fauci, MD

National Institute of Allergy and Infectious Diseases

Washington, D.C.

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:

1. There are generally two stages of COVID-19 symptomatic infection; initial flu like symptoms with progression to cytokine storm and respiratory failure, correct?
2. When people are admitted to a hospital, they generally are in worse condition, correct?
3. There are no specific medications currently recommended for early outpatient treatment of symptomatic COVID-19 infection, correct?
4. Remdesivir and Dexamethasone are used for hospitalized patients, correct?
5. There is currently no recommended pharmacologic early outpatient treatment for individuals in the flu stage of the illness, correct?
6. 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?
7. 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?
8. These high-risk individuals are at high risk of death, on the order of 15 percent or higher, correct?
9. 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?
10. 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?
11. Have you heard of the “Zelenko Protocol,” for treating high-risk patients with COVID-19 as an outpatient?
12. Have you read Dr. Risch’s article in the American Journal of Epidemiology of the early outpatient treatment of COVID-19?
13. Are you aware that physicians using the medication combination or “cocktail” recommend use within the first five to seven days of the onset of symptoms, before the illness impacts the lungs, or cytokine storm evolves?
14. 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?
15. Would you advocate for early pharmacologic outpatient treatment of symptomatic COVID-19 patients if you were confident that it was beneficial?
16. 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?”
17. 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?
18. 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?
19. 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?
20. 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)?”
21. But NONE of the randomized controlled trials to which you refer were done in the first five to seven days after the onset of symptoms, correct?
22. All of the randomized controlled trials to which you refer were done on hospitalized patients, correct?
23. Hospitalized patients are typically sicker that outpatients, correct?
24. None of the randomized controlled trials to which you refer used the full cocktail consisting of Hydroxychloroquine, Zinc, and Azithromycin, correct?
25. While the University of Minnesota study is referred to as disproving the cocktail, the meds were not given within the first five to seven days of illness, the test group was not high risk (death rates were 3 percent), and no zinc was given, correct?
26. Again, for clarity, the trials upon which you base your opinion regarding the efficacy of Hydroxychloroquine, assessed neither the full cocktail (to include Zinc and Azithromycin or doxycycline) nor administered treatment within the first five to seven days of symptoms, nor focused on the high-risk group, correct?
27. Therefore, you have no basis to conclude that the Hydroxychloroquine cocktail when used early in the outpatient setting, within the first five to seven days of symptoms, in high risk patients, is not effective, correct?
28. 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?
29. 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?
30. The SARS-CoV-2/COVID-19 virus is an RNA virus. It is well-established that Zinc interferes with RNA viral replication, correct?
31. Moreover, is it not true that hydroxychloroquine facilitates the entry of zinc into the cell, is a “ionophore,” correct?
32. Isn’t also it true that Azithromycin has established anti-viral properties?
33. 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?
34. So, the use of hydroxychloroquine, azithromycin (or doxycycline), and zinc — the “HCQ cocktail” — is based on science, correct?

QUESTIONS REGARDING SAFETY:

1. 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?
2. Isn’t it true that the drug has been used for lupus and rheumatoid arthritis for many years at similar doses?
3. 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?
4. 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?
5. 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?
6. 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”?
7. 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?
8. 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?
9. If there was such good data on the risks of hydroxychloroquine, one would not have to use fake data, correct?
10. After all, 65 years is a long-time to determine whether or not a drug is safe, do you agree?
11. 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?
12. 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?
13. 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?
14. Are you aware that pharmacies are not filling prescriptions for this medication based on your and the FDA’s restrictions?
15. 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?
16. Are you aware that people who want the medication sometimes need to call physicians in other states pleading for it?
17. And yet you opined in March that while people were dying at the rate of 10,000 patients a week, hydroxychloroquine could only be used in an inpatient setting as part of a clinical trial- correct?
18. So, people who want to be treated in that critical five- to seven-day period and avoid being hospitalized are basically out of luck in your view, correct?
19. 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:

1. 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?
2. 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?
3. You repeatedly state that randomized clinical trials are needed to make conclusions regarding treatments, correct?
4. The FDA has approved many medications (especially in the area of cancer treatment) without randomized clinical trials, correct?
5. 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?
6. 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?
7. Frieden discusses “practiced-based evidence” as being essential in many discoveries, such SIDS (Sudden Infant Death Syndrome). Do you disagree with that?
8. 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?
9. 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?
10. 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?
11. 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?
12. 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?”
13. 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?
14. 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?
15. 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?
16. 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?
17. 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?
18. So, it would be false to conclude that the evidence supporting the early use of hydroxychloroquine is anecdotal, correct?

COMPARISON BETWEEN U.S. AND OTHER COUNTRIES REGARDING CASE FATALITY RATE:

(IT WOULD BE VERY HELPFUL TO HAVE THE GRAPHS COMPARING OUR CASE FATALITY RATES TO OTHER COUNTRIES.)

1. Are you aware that countries like Senegal and Nigeria that use hydroxychloroquine have much lower case-fatality rates than the United States?
2. 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.?
3. Have you considered consulting with a country such as India that has had great success treating COVID-19 prophylactically?
4. Why shouldn’t our first responders and front-line workers who are at high risk at least have an option of HCQ/zinc prophylaxis?
5. 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?
6. 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:

1. 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?
2. Are you aware that the cost of the hydroxychloroquine “cocktail” including the Z-pack and zinc is about $50?
3. You are aware the cost of remdesivir is about $3,200?
4. So that’s about 60 doses of HCQ “cocktail,” correct?
5. 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?
6. 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?
7. But because of your obstinance blocking the use of HCQ, this stockpile has remained largely unused, correct?
8. 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?
9. 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?
10. 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?
11. 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?
12. 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?
13. 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?
14. 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?
15. 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?
16. 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?
17. Are you aware that their website, American Frontline Doctors, was taken down the next day?
18. 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?”
19. 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?
20. 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?
21. Don’t you think doctors should have the right to speak out on behalf of their patients without the threat of retribution?
22. Are you aware that videos and other educational information are removed off the internet and labeled, in the words of Mark Zuckerberg, as “misinformation?”
23. Is it not misinformation to characterize hydroxychloroquine, in the doses used for early outpatient treatment of COVID-19 infections, as a dangerous drug?
24. 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?
25. 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?
26. 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?
27. Don’t you realize how much damage this falsehood perpetuates?
28. 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?
29. 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?
30. Why not give our healthcare workers and first responders, who even with the necessary PPE are contracting the virus at a three to four times greater rate than the general public, the right to choose along with their doctor if they want to use the medicine prophylactically?
31. 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?
32. Why not give the American people the right to decide along with their physician whether or not they want outpatient treatment in the first five to seven days of the disease with a cocktail that is safe and costs around $50?

FINAL QUESTIONS:

1. 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?
2. For example, if the NIH were now to direct a study to begin September 15, where would such a study be done?
3. 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?
4. 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?
5. 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?
6. 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 US physicians (and thousands more around the world) would manage this case with the HCQ cocktail with predictable success.
7. 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 five patients in England, or would you have stated that a randomized clinical trial was needed?
8. 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?
9. 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?
10. 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?
11. 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.

1. 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?
2. 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.

CONCLUSION:

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.”

Very Respectfully,

George C. Fareed, MD

Brawley, California

Michael M. Jacobs, MD, MPH

Pensacola, Florida

Donald C. Pompan, MD

Salinas, California

[UPDATE: I would like to add these curious graphs.  Theory: as HCQ became unavailable thanks to FDA and Dr. Fauci, viral loads increased, R0 skyrocketed, and death rate increased.]

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Fact Check: How to Survive Coronavirus in Three Easy Steps [UPDATED]

As if Coronavirus isn’t bad enough, our "experts" are all at war with each other!  One scientist says one thing and another says the exact opposite. One doctor expresses an opinion and the next day is fired for heresy. New studies come out and their results are contradicted by the very next study. Respected journals of science and medicine publish peer reviewed papers and have to retract them a week later. The WHO, FDA, and CDC take definitive positions and then reverse them shortly thereafter. Doctors are forced into suing the FDA for not allowing them to use drugs they say save lives. 

If the experts can’t sort this out, what chance do you and I have? Well,  it turns out we have a pretty good chance.  Here's why:  Coronavirus hit every country in the world with the same unique challenge, and each country took a different approach.   By studying which countries were successful and which ones weren't, we can benchmark the things that work.  No, it’s not perfect. There will always be data issues, timing issues, and hidden variables.  But real world results have a story to tell, and we should probably listen closely when people are dying by the thousands each day. 

With that in mind, I took a deep dive into the country data to see if I could untangle three big controversies swirling around the pandemic:

• Do masks work?
• Does Hydroxychloroquine (HCQ) work?
• Which healthcare systems are handling Coronavirus the best?

And finally, how are we measuring-up in the U.S.?


#1 Do Masks Work?

Masks are not a consensus issue even today.  There are still scientists and doctors who claim they are useless and even harmful.  But as the above graph shows, the five countries that first embraced masks in Europe have much lower infection rates than their neighbors that never did. The five with the highest infection rates were either very late, or still do not wear masks today.

Think of Coronavirus as a car accident. The first strategy for surviving a car accident is avoiding one in the first place, right?  For Coronavirus, wearing a mask is like having good tires and brakes. Masks keep infection rates down, and that is job one when dealing with a deadly new pathogen that we don’t fully understand.

So why limit this analysis to European countries?  Here's why:  The following graph appeared early in the pandemic comparing Asian countries to the rest of the world.  Sure enough it suggested Asian countries had lower infection rates due to masks. Some Asian countries have been wearing masks since the 1918 Spanish Flu! Critics, however, pointed out that other variables such as genetics, diet, culture, etc. could be at play. I wanted to reduce those variables by just looking at European countries.




Of course, masks are just the last line of defense against Coronavirus infection.  A healthy immune system full of Vitamin D,  proper distancing,  proper weight, good diet,  etc. are all equally important.  But if all else fails, masks buy time and keep viral loads to a minimum.

So what happened in the U.S.? Why were we so late to the masked ball?

Here's a compilation of "experts" , The W.H.O., Dr Anthony Fauci, and Surgeon General Jerome Adams, all telling us in March that masks were unnecessary and even harmful! First impressions matter, and we got off on the wrong foot. We currently have one of the highest infection rates in the world. The W.H.O., Dr. Fauci, and Dr. Adams cut our brake lines and gave us bald tires at a critical stage in the pandemic.

President Donald Trump blew this one. He should have overruled the experts.  Recently, he and Fauci et al. have reversed course, and we are now belatedly on track to be fully masked.

#2. Does Hydroxychloroquine (HCQ) work?

If you somehow do get infected, what should you do? Or, keeping with the car accident analogy, is there an equivalent to a seatbelt and airbag for Coronavirus?  It turns out there is, and it’s called Hydroxychloroquine (HCQ). Countries that use it have lower Case Fatality Rates than those that don't, and it's not even close.  

The effort to discredit HCQ may the biggest health hoax in history. Nearly 700,000 people have died globally and far more have permanent organ damage as of this writing. How many could have been spared if there hadn't been a coordinated and thus far successful attempt to prevent this cheap, available, safe, effective therapy from gaining traction? We'll never know, but the case needs to be adjudicated publicly.  Instead, one side is being systematically blocked and censored.  

Despite what you’ve been told, the science unequivocally supports early use of HCQ:

According to every known scientific study of HCQ so far, 100% of the pre-exposure, post-exposure, and early use studies have shown HCQ to be effective when results were conclusive.  100%!  It's most effective when given early and combined with ZINC plus Azithromycin or similar antibiotic.  So why have you been told otherwise?

There are three possibilities:

One is that there may have been an early misunderstanding about HCQ.  We have known since 2005 that HCQ is effective on SARS coronavirus in vitro (in a test tube). Yet most of the early HCQ studies were done with patients who were well beyond the viral stage of the illness. It was like studying the effectiveness of airbags by deploying them days after a car accident!  And we know that zinc plays a crucial role with HCQ, yet almost none of the studies bothered to include it!   

Another possibility is that HCQ is a direct threat to Big Pharma, which hopes to cash in on expensive newly patented therapies like Remdesivir, anti-bodies, and vaccines. As if by magic, very favorable things always manage to be amplified regarding these profitable options, and very damaging things are amplified about generic HCQ. The amplification NEVER goes the other way. And this imbalance goes all the way up the chain of command to government health officials around the world. It's like they are all paid spokesmen for Big Pharma!

And finally, there are the politics of HCQ. The moment President Donald Trump spoke hopefully about HCQ it became a political imperative for his opponents to stop this drug from ever being accepted. The earliest Western HCQ proponent was a French doctor named Didier Raoult. Success for Dr. Raoult and HCQ meant success for Trump, and that could not be allowed regardless of the collateral damage. Hit pieces like this one in The New York Times popped-up like mushrooms bad-mouthing Dr. Raoult. He was dubbed a "barking mad dangerous witch-doctor". Every subsequent proponent of HCQ has suffered a similar fate.

In the end, negative media reports on Hydroxychloroquine outnumber positive ones by orders of magnitude. The message is clear, and it has worked wonders at hurting Donald Trump's poll numbers and raising death rates around the world:

Many others have studied the correlation between HCQ use and low CFRs.  Below is a vivid example:

Source: Anonymous Twitter user @gummibear737

The following graph is from a lawsuit filed against the FDA by the Association of American Physicians and Surgeons (AAPS):

and finally, this very recent randomized study using Adjusted Deaths per Million, which shows HCQ countries have 79.1% lower deaths:   (Hat tip -Twitter user @CovidAnalysis)

So what went wrong in the U.S. with HCQ? Like with masks, it starts with the most influential voice in the country, Dr. Anthony Fauci.  And again he blew the call.

When the subject of HCQ first came up, Dr. Fauci pooh-poohed it saying he needed a time-consuming peer-reviewed double-blind study. After all, that is the gold standard in drug testing.  But, does that make sense during a deadly pandemic with a centuries old class of medicines that have been proven safe,  proven efficacious in vitro, and have proven clinical results against this very Coronavirus?  Fauci had the burden of proof completely backwards! With no viable options and people dying, the burden of proof was on the skeptics.

Then Dr. Fauci and the NIH applied a completely different standard to a new medicine called Remdesivir. Here was a medicine that had no peer-reviewed double-blind study, no track record, no safety profile, and no history with Coronavirus, yet Fauci touted it as a "game changer".  Unlike HCQ, there were billions of dollars to be made with Remdesivir.  It later turned out that several of the scientists reviewing Remdesivir for the NIH had financial ties to Gilead Sciences, the holder of the Remdesivir patent!       

Nevertheless, on March 28th the FDA reluctantly issued an Emergency Use Authorization (EUA) for HCQ.  Next came a slew of negative late-stage studies. Almost all of them were done on hospitalized patients long past the viral stage of the illness and nearing death.  And none of them included zinc.  An antiviral like HCQ, even with zinc, cannot resuscitate patients with severe lung, brain, heart, and kidney damage!     

What followed next was truly a "Theater-of-the-Absurd".

On May 22nd, the highly respected British publication, The Lancet, published a huge negative study on HCQ.  It was so devastating that The W.H.O. immediately dropped all attempts to test the drug and recommended it not be used.  The FDA followed suit shortly thereafter.

Except there's one small detail I skipped: The influential Lancet study was completely discredited and retracted! The data was entirely made-up!  It was all fake!  But that has not stopped The W.H.O,  FDA, NIH, CDC, nor Dr. Fauci from proceeding with their campaign against HCQ.  This all stinks to high heaven.  Meanwhile, six thousand people die globally from Coronavirus every single day.

Here's what has happened in the U.S. since the FDA ended the EUA for HCQ:

The saddest piece of data in the U.S. is that the two states that make up about a third of all deaths, NY and NJ, totalling 48,725 dead as of 8/5/2020, took decisive action to make sure no one could possibly be saved by HCQ.

On March 3, NY Governor Andrew Cuomo issued an executive order that among other things strictly limited the use of HCQ:

No pharmacist shall dispense hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted...

This effectively banned HCQ use in NY when it could have been most effective against the disease. Waiting for test results could mean a possible 14 day delay in treatment when patients would be well beyond the viral stage of the illness.

On March 9th, NJ Governor Phil Murphy also issued an executive order declaring a state of emergency, and by March 29th NJ had strict restrictions on prescribing HCQ:

All dispensing of hydroxychloroquine and chloroquine for treatment of COVID-19 shall be limited to prescriptions supported by a positive test result, which must be documented on the prescription.

The reason for these limits was ostensibly to prevent Lupus and other Autoimmune patients from running out of HCQ.  But those patients are not in danger of dying and have many treatment options. Coronavirus patients are in mortal danger and have no other options. This ensured no NJ or NY resident could get early outpatient treatment with HCQ when it was the only thing that could have saved them.

Here's the bottom line:  The W.H.O, Dr. Anthony Fauci, Big Pharma, the media, and anti-Trumpers, slashed our seat belts, disabled our airbags, and made this pandemic much, much worse than it needed to be.  To his credit, Donald Trump had the right instincts on HCQ, but was unable to overcome the forces against it.

HCQ is not the only cheap, available, and safe treatment being looked at for Coronavirus. Some others are Ivermectin, Artemisinin, Quinine, Quercetin, and Green Tea.  All of these share one thing in common with HCQ - they are all zinc ionophores.  Here's how it was explained to me: zinc ionophores facilitate the transport of zinc ions into cells.  Zinc is particularly good at interfering with all sorts of mischief by cellular invaders.  A useful analogy is this; the ionophore is the gun and zinc is the bullet. (H/T Dr. Zelenko)  Doing tests on zinc ionophores without zinc is like testing guns without bullets.

[UPDATE: Ivermectin may be a miracle drug.  The success of this drug against SARS-COV-2 appears to be stronger than any other single therapeutic.  Keep and eye on Ivermectin.  Interestingly, it shares a trait with Azithromycin: both are derived from bacteria in soil!]   

(The countries in my HCQ graph were chosen from this study published in April, with one exception.  Costa Rica's outbreak was late and therefore was not included, but they famously responded using the S. Korea model and have had dramatic results.  Since I could only include ten countries before the graph got cluttered, I chose the ten with the most and least success.)      


#3 Which healthcare systems are handling Coronavirus the best?

The pandemic presents a unique opportunity for comparing healthcare systems around the world.  As it turns out, the healthcare systems that performed well were the ones that had a robust free market component, and the ones that did poorly were the most bureaucratically socialized ones. (Like with masks, I kept this mostly to European countries to minimize variables.)

I don't mean to pick on France, Italy, UK, Belgium, etc., but there’s a pattern. These countries, in addition to being late on masks and Hydroxychloroquine, also have the most highly socialized healthcare systems in the world. Ask yourself this, if you had a life-or-death shipping problem and needed a quick innovative solution, would you go to the U.S. Postal Service, FedEx, or UPS?  These socialized countries had only their post-offices to turn to.

I first stumbled on this correlation while studying economic freedom and death rates.  Early in the pandemic I found a strong correlation between economically free countries and low CFRs,  but the correlation faded as the pandemic progressed. What never changed were the outliers - free countries with very high CFRs. After looking into it, I found that these countries all had highly socialized healthcare systems with no significant free market components.

Ironically, The W.H.O., also wrong about masks and Hydroxychloroquine, ranks healthcare systems.  Lo and behold, France and Italy take first and second place respectively!

To be clear, having some socialized healthcare is the norm around the world. Even in the U.S. we have tons of socialized medicine. In fact, if you take Medicare, Medicaid, Obamacare, and SCHIP together, they comprise the largest government healthcare program in the world. And yet our CFR is in the low range. That’s because we also have a robust free market in healthcare alongside our socialized system.  

President Donald Trump again has the right instincts here.  He's tried to increase free market healthcare in the U.S., but has been thwarted by both Republicans and Democrats in congress. 


Conclusions - How to Survive Coronavirus in Three Easy Steps: 

• Masks correlate with low infection rates. Wear a mask when in close quarters.
• HCQ correlates with low fatalities. Make sure your doctor understands HCQ, zinc, and zinc ionophores in general.  [UPDATE: plus Ivermectin!] 
• And free market healthcare correlates with low fatalities. You don’t want to be stuck in post-office healthcare when your life depends on it.  

I suggest you contact your doctor and make sure they are up on these issues.  Mine was not, and I’m glad I found out early.  [UPDATE: I was able to obtain everything I wanted through telemedicine.  This link works well for getting a referral:  https://speakwithanmd.com/americasfrontlinedoctors/ ]

As noted above, there are plenty of herbal over-the-counter zinc ionophores like quercetin and green tea.  And of course, zinc is readily available.

I wonder what would happen in the presidential race if one of the candidates pledged to make HCQ w/zinc over-the-counter?  Many drugs, like ibuprofen (Advil) are OTC in low doses, but require a  prescription for higher doses.  Could that be done with time-tested drugs with proven safety records like HCQ and Ivermectin?   



One final note on why these analyses use Case Fatality Rates (CFRs) and not Fatalities per million population.  Since these analyses compare treatments and outcomes (ie: HCQ & healthcare vs. deaths), only those that are treated are included. Using Fatalities per million population would introduce widely variable infection rates into the analysis and infection rates have nothing to do with treatments.  Infection rates are also important, but they are a function of masks, distancing, culture, lifestyle, age, etc., which is why they were used in the mask analysis above.  (original charts are based on data from www.ourworldindata.com)

My Op-Ed to WaPo's: "Americans are suffering. Trump offers them a doctor who warns of sex with demons."

Read the whole opinion piece here.

Here's my op-ed:  (Originally slated for Facebook to those promoting this WaPo smear, but I'm weary of playing the skunk at the leftist picnic. And that's what FB is.  Luckily, I have a blog.)

Some thoughts: 1. This doctor is a black woman.  She treats patients daily at her clinic.  Many have COVID.  She's been successful using Hydroxychloroquine.  Who are you to question her clinical experience?  2. Did it ever occur to you that when she refers to "demon sex" or "alien DNA" she is speaking to a similarly African religious population?  Who are you to judge the idioms of the African religious community?  3.  Are you aware that Hydroxychloroquine belongs to a class of drugs that has been around for centuries and probably millennia?  Did you know Alexander Hamilton was cured of Yellow Fever in 1793 using quinine and Madeira wine (high in zinc)?  Do you know that centuries of science are on her side, not yours?  Your snarky condescension towards this Black, African, female, religious, doctor, reeks of racism, sexism, white privilege, small-mindedness, cultural superiority, religious intolerance, entitlement, and ignorance. You remind me of those Japanese soldiers stranded on Pacific Islands who had no idea WWII was over.  Only the islands you are stuck on are information islands like WaPo, NYT, CNN, NPR, etc., and all the digital media who censored this courageous truth-telling doctor.  But it might be even worse.  You probably know that she and centuries of science are right about HCQ.  You probably know that Donald Trump was right about HCQ.  But you don’t care.  Instead, you shout them down like lunatics. Here’s your sick calculus: sacrificing a few hundred thousand more lives to elect Joe Biden's animated corpse in November is worth it to you because you want power more than anything. In which case you are the very demons Dr. Immanuel was referring to, and no one should have sex with you.  (I'll see myself out...)   Undiepundit.com