I was out that night looking for the meteor shower in Riverside Park, New York City, but NYC was totally overcast and I didn’t even see a “blink” through the cloud cover.But Arizona got “the blast,” at 40/minute.
I had to wait 33 years for the next greatLeonid Meteor shower, which came in December 1999 when the Leonid Meteor shower, which i saw from the Great Oval in Central Park and got some of them on video.
The Night of the Eta Aquarid
One night in In May of the year 2000, I was flying a T-tailed Piper Arrow II RT in the dead of night from Boston to Essex County – Caldwell Airport, New Jersey, which is just a few miles outside New York City.
It was about 9:30 p.m., flying in the black of night over Oxford-Woodbury, Connecticut. The sky was black , but visibility was unlimited and I could see the stars. the land was black, but I could see the lights of highways, occasinal street lights, and some house lights in the little sleepy towns below.
As I flewwest, homing in on the 310 radial of a VOR beacon in Carmel, New York, I glaced down at the landscape passing below my aircraft.
Suddenly, as I was making out the coast line of Connecticut to the south along Long island sound, I was very surprised as I looked down at a brilliant luminosoity on the gound, which made no sense to my ratiional mind.
As I looked at this puzzling sight, I thought I saw “a lake on fire” or “fireworks underwater (?).” I was mesmerized by the sight of it what looked to be a fiery lake, adn I thought of an amusement park or somesuch thing as the possible cause for this most ununusual never-before-seen phenomenon.
My eyes stayed fixed for several seconds on the rainbow of brilliant streaks of light emanating, as it seemed from beneath the waters of the small lake, until the fiery lake disappeared under my left wing.
When I looked forward again, I could see diffuse green and yellow bands of light wavering over the dimly lit landscape and I was puzzled by the effect illuminating the hilltops of Connecticut when it had been pitch black just 10 seconds before, except for street and highway lights, 6500 feet below.
I looked for the light source and looing south, I could see “late afternoon sunlight,” shimmering in long Island sound and the Atlantic ocean farther south.
I could see all of Long Island as a black mass floating in a sea of silver light, and when I raised my gaze to the sky, I thought I was looking at the sun. My brain went “bonkers,” and slipped into cognitive dissonance for a moment as i said to myself :
“Did I miss the dawn? … Am I on my way to Holland?” <simultaneously Thinking of Lindberg + “Holland Tunnel”>
I glanced forward once again to see the land was still dimly lit with now brighter green and yellow “tiger stripes” wavering cross the Connecticut hills. I could see 2 “rectagular lakes,” which later turned out to be local reservoirs.
Looking back at “The Sun,” I noticed that it had dropped a couple of degrees in declination and now had a white aura surrounding it, so my next thought was “O my God, It’s a Supernova.” but as i thought it, I saw the luminosity drop nd stop twice move, vertically, like a spider sometime “drops and stops” suddenly while hanging on its silken thread.
The object was now lower than before and the aura around it looked like was boiling, at which point it leapt and streaked right toward me and an intersection with my airplane’s line of flight, ‘bouncing” twice (like the bouncing ball in old cartoons) and covering a distance of 50-75 miles in two “hops” lasting only 2 seconds in duration.
the object was now nearly upon me and realizing it was meteoric, I scream or yelled out loudly out “METEOR!” to alert my co-pilot and my passenger in the rear seat, a USAF Tech Sgt. named William Larrea.
The object seemed to slow down suddenly and changed color and shape from bright white roundness to a long fiery green and red object, shaped like a black apple see, with a ruby colored “belt” or ring around its center and a “ruby knuckle” like ajewel on a ring, and spinning/rotating like a beacon.
My inner voice said “Don’t stare at the ruby belt ’cause you’ll miss the rest of it!”
So, I broke my fixation on the spinning ruby belt to take in the rest of it, which was a green color of every possible shade and hue of green from lime green to Kelly green and the saw a 100 foot long acetylene torch like tail , and as my flight line was on a collision course with the streaking object, I said to myself:
“If I fly through that tail, it will shear my wing and ‘Bang!, ” my plane will explode and the NTSB accident report will only say “pilot error.”
“I had seen beyond the edge of the world. I had seen a whole new form of life and way of being human that has hitherto remained hidden.” Whitley Strieber, SolvingtheCommunion Enigma, p. 39.
TIME HAS A WAY WITH MAGIC
Time had a way of encapsulating memories and solidifying events. The year 1975 held a number of surprises (it was the year my ex-wife hit me with a whammy divorce and introduced me to the surreal world of lawyers and marital subversion; she also brought up in court that I had an interest in ufology), but it was also the year that UFO heroes sat down and discussed the reality of the UFO phenomena.
A dynamic trio of Dr. J. Allen Hynek, Jacques Vallee and Dr. Arthur C. Hastings; Hastings a renowned psychologist; Hynek, the late Professor of Astronomy at Northwestern University, consultant to the United States Air Force, and founder of the Center for UFO Studies; Vallee, a doctor in computer science at Stanford University, all three examined the phenomena from various aspects in this classic book.
(TheEdge of Reality:AProgressReportonUnidentifiedFlyingObjects, J. Allen Hynek and Jacques Vallee, Henry Regnery Company, Chicago, Illinois 60601, 1975, 301 pages, $13.46.)
One thing that stood out pointedly in their conversations was the seeming “magic” aspect of some cases, real, to the effect that physical traces are left, but the UFO activity seem abnormal and often etheric.
“…there is a strong case here for psychic aspects of UFOs,” says Vallee, “but just saying that UFOs belong to the realm of psychic phenomenon doesn’t explain them.” Vallee adds: “It may be that there is inherent in our species, a sort of built-in defense mechanism, that reveals itself only in times of extreme social stress, and one of its manifestations is the phenomenon known as UFOs….that certainly produces some very unusual biological consequences…a triggering of a genetic process…people seeing things in the sky, and various physical effects might even result.” That sounds a lot like saying Mother Earth, Gaia, is speaking to us.
Even though the book told of very spectacular and bizarre cases, such as the November, 1961 UFO case where hunters allegedly shoot a UFO occupant with a .22 HornetWinchesterModel43, scoped and with a WeaverK–49 (the wounded occupant-being cursed in plain bawdy-English), there is no other documentation, such as from the mysterious men who came from the government to visit one of the UFO witnesses, or an forensic analysis of the gun which had been fired. The case had the Kafkaesque quality: “Sounds like humans were somehow involved coming from a UFO, or, was that just a disguise, or what?” you ask yourself.
“We have good evidence now that every culture on earth has a tradition about little people, endowed with supernatural power,” says Vallee, “doing things like flying, kidnapping people, taking them away, sometimes cohabiting with human females, sometimes being useful to humans, sometimes being playful, sometimes being destructive, very predictable…they are all over the world.”
Likewise, the UFO sighting of August 7, 1970 at the village of Saladare, Asmara, Ethiopia seemed to have much more substance, leaving great physical damage in its wake. One can only wonder why the medical doctor did not collect samples to be medically and forensically tested in a competent laboratory.
Entered Whitley Streiber, known as an international bestselling author of more than twenty novels and works of nonfiction, many, such as his personal CloseEncounteroftheThirdKind (taking a term from Hynek), contend with his encounter in the December of 1985 (Communion). Some of his fiction books were the bases of movies: TheWolfen, The Hunger, and TheComingGlobal Supertorm.
(Solving the Communion Enigma: Whatis to Come, Whitley Strieber, Jeremy P. Tarcher/Penguin, Penguin Group, Inc., 375 Hudson Street, New York, New York 10014, 2011-2012, 213 pages, $16.95.)
TRANSCENDING REALITY
Strieber has joined the ranks of Fortean or paranormal writers that have become “experiencers” that had to contend with encounters with extra-strange and unusual phenomena. The reader can go to his website to review many of these episodes.
Solving the Communion Enigma is one of Strieber’s best and latest attempts to explain the intimate and personal meaning of his (and those of other “experiencer”) stories. In the end of his renditions, Strieber gives a number of theories which are perhaps his “best guesses” as to the nature of his abductions and UFOs in some fruitful understanding.
“It is important to assume nothing; to study what is accessible to study, which is the physical evidence,” says Strieber, “and to methodically close the outstanding questions as we become able to do so.” (p. 212)
Strieber begins his “unraveling” through random conjecture about his “experiencer” books, Transformation, Breakthrough, and Communion. Strieber stresses that he never had been an expounder of his “contactee” experiences as episodes with “alien contact.” Rather, he says his encounters truly pointed at something much deeper: what the power ofevolution appears to be when seenin its hidden lair by a “conscious mind.” (p. 3.) The phenomena are far too complex “and spectacularly strange” to be diagnosed as something that fits into current scientific or historical paradigms. (p.5)
Strieber finds fault with the popular thought expounding “extraterrestrial visitors” (much like the late astronomer and UFO investigator Dr. J. Allen Hynek also concluded) as the origin of UFO phenomena. Hynek and Strieber were puzzled as to how normally-conceived “visitors” could travel the gargantuan and phenomenological enormous vastness of interstellar and galactic space with such seeming ease and epochal mastery.
Strieber surmises that whatever we are dealing with, “something here among us that acts in an intelligent manner, but not in ways that we might act.” (p. 212)
MYSTERY GROUPS
Strieber eventually ventures into an inevitable avenue of speculation: Childhood and mysterious organizations, periods in the lives of children where many unanswered questions arise. In this case, Strieber brings forth his own bizarre childhood encounters as well as experiences of other people.
The author gets into a rather convulsed story of a group identified as “The Finders,” originating in 1987, but ranging through links of “a school for brilliant children,” the CIA, MK-ULTRA, military hospitals, the Wolf-Mullen testimony about child abduction (including the testimony from Harvard psychologist Jennifer J. Freyd) hidden in a vast bureaucracy which, says Strieber, cloaked a reality of “traditional” organizations such as Congress and executive government that controlled and experimented. (p. 37.)
Strieber had experiences with “visitors” that could notjust be classified as ‘alien,’ at least, not in the classical sense. He recounts his old friend, film-maker, and photographer Timothy Green-Sanders, having told him of encountering a “woman” that was a ‘human’ version of the ‘alien’ on the cover of Streiber’s Communion, the woman spoke some strange comments and rushed off, having appeared as human and yet alien.
Editor Bruce Lee had the same-type experience in Manhattan as the “aliens” examined Communion at a bookstore, quietly ridiculing (to the aliens) historical inaccuracies (how Lee was able to determine all this is not clear).
Another account Strieber relates is his sighting of a strange “humanoid” ‘lady‘ that walked in a rather “penguin-like” gait as she disappeared.
STRANGE ‘PEOPLE’—STRANGE OBJECTS
Other people had seen these “strangers” on Strieber’s property. Strieber also received “ominous” phone calls. A young boy was seen “smoking” a cigarette under some pitch pines (which are a hazard): when Strieber approached him, he discovered the “boy’ was more like a “man”—a weathered child—that caused Strieber’s immediate departure. Later, upon continued ‘visitations,” Strieber tried to track the “boy-man” down, but without success. Neighbors had seen the “visitor” too.
“Cigarette smoke,” says Strieber, “a strange feral child who could climb walls and did things that were faintly ominous and inexplicable__but no, it was impossible. We left all that behind in upstate New York.” (p. 47)
The Smoking Man
Cigarette smoke and the strange boy continued to haunt the Striebers. Strange men, black cars, the flickering of a motion sensor light, and even tiny “implants” in his own body that he recalled back to May of 1989.
Bill Mallow and Strieber worked on a number of so-called “implants”; one as made of “sital,” and another one was made of magnesium and bismuth. Dr. Rodger Leir tested sixteen objects. Six emitted “radio signals” ranging from 8 HZ to 516812 GHZ. Most were pure iron, some with nickel and other metals.
A 99 percent pure iron specimen returned a signal when placed in a diffractometer—then stopped; it became X-ray diffraction ‘invisible.’ Their work stopped when Bill Mallow received a “nod” from his employer that a CIA client was disapproving.
Alleged Alien Implants
Strieber also was “implanted” in May of 1989. He recalls two people and one was a female who comfortingly humming in his hazy recollection. Later, the ear that was operated on would turn bright red in the presence of Bill Mallow and Doctor John Lerma. The implant was found to be a small white metallic dish with organic cilia growing out of it.
“If there were not seventeen proven implants but ten thousand,” says Streiber, “then there could be some amazing research done. A record of the radio frequencies in the user could be gathered. The witnesses could receive extensive physical and psychological examinations…how brains functioned…interesting data could be gathered…” (p. 65)
The implants demonstrate, says the author, the “aliens” ability to maintain control beyond our hapless efforts to find answers.
DISTANCES AND QUANTUM PHYSICS
Strieber and many other researchers had worried, and even become hostile, to discuss the enormously vast distances that would have to be overcome to conveniently travel the distances between planets, galaxies and various outer-space points. Physicist Enrico Fermi doubted that said aliens could travel here, and Strieber indicates the mode of travel would have to be quantum-physical “spooky action.” Strieber typifies this possible technology in the famous sightings of September 18, 1976, when a Colonel (now General) Parviz Jafari encountered a mysterious craft that could jam weapons and radio, and perform unbelievable feats.
Enrico Fermi and Wife Laura
There were several other UFO cases that exhibited similar abnormalphantasmagoria. Two pilots from RAF Manston in Kent, England were ordered to scramble an intercept of a UFO on the night of May 20, 1957, and one pilot fired his entire salvo of twenty-four MK-40 rockets at the object which appeared larger than an aircraft carrier as it appeared to be on the radar. Then the object disappeared. The NSA classified the report known phenomena and the CIA explained the radar blip as a government experiment.
EARLY UFO FLAPS
“Mysterious airplanes” and “descending aircraft” were seen over New Jersey, USA, as well as Norway, Sweden and Sussex, England in what might be called a “1930’s UFO Flap.” These “phantom planes” seemed to highlight an origin in which the objects had already transcended transatlantic flight. Some were reported as “orbs” and even “flying swords and coffins.” (p. 91)
There were other significant “flaps” about the world, such as in France in a European UFO wave in 1954 but Dr. Paul Hill’s UFO sighting of July 1952 signified the tone of the so-called U.S flap of 1952.
“Dr. Hill’s 1952 sighting was part of a massive UFO incursion that took place over the summer of that year,” says Strieber. “This huge flap involved sensational sightings over Washington, and the Air Force’s attempt to explain them as temperature inversions were not convincing to many people.” (Hill’s UFO case included an object that seemed to manifest static-electric-field technology, utilizing a ‘falling leaf’ motion. Likewise, Hill and his wife had a rather unusual sighting on July 16, 1952, at Chesapeake Bay: two thirty-foot amber objects that demonstrated strange and unusual aerobatics.)
Strieber treks through various “classical” cases (such as July 14, 1952, Pan American sighting by pilots William B. Nash and William H. Fortenberry over the Chesapeake Bay), each example had their own peculiar element that something paranormal was indeed happening.
A NEW SCIENCE
The remainder of Stieber’s book explores the growing modern stages of science and its viewing of nature and other unusual UFO and abnormal phenomena. He includes strange cases of animal mutilations that surround birds, cats, dogs, and cattle, seen along with orbs and strange aerial objects.
“The butchery is neat, and the incisions in some cases appear to have been accomplished with some sort of laser,” says Strieber. “…the precision instruments that are generally available would not be appropriate to cut a cat in half.” Similarly, a human was mutilated near Guarapiranga Reservoir in Brazil.
Mysterious creatures, mysterious encounters go by different names and different descriptions in various localities about the globe. JinnKutcaci, Zetas, Deros, Pleiadeans: “What manner of mind creates such a bizarre combination of events? The contrasts in the contact experience are fantastic,” says Strieber. (pp. 139, 141, 142)
(Strieber outlines the “Crop Circle” manifestations that usually take place in England countrysides, saying some appear inexplicable: This is a slippery slope, in as much as many have been proven to be confessed hoaxes by various talented human groups, sometimes done in cooperation with the farmers, some with various gimmicks, none beyond what a well-trained government SWAT Team could not eventually expose. And one must ask: Why are almost all ‘circles’ usually and exclusively found in the farms of Great Britain?)
Strieber implores that our ‘visitors’ are here to aide, guide and train us into a new reality, an improved evolutionary process.
The Aliens of Whitley Strieber
“From my experience, we are not living in a simple world where a table is a table and a chair is a chair…If I am correct in my analysis, then something is missing from the way we see reality__in fact, that essential thing is missing, and until we have connected with it, we will remain deaf, mute and blind to most of the real world, and almost all of the world our visitor inhibit,’ says Strieber, “they can try to get us to realize that we are blind, but they cannot open our eyes for us. That we must do our selves.” (p. 106)
THEY ARE TAPESTRY
Are We Products of Alien Terra Farming?
There are alternative and additional ‘stipulations,’ however, that can explain some aspects of the phenomenon—those mentioned above plus the possibility that UFOs come from alternate ‘sources‘—but (or should I say ‘and’?) those various origins have begun to blend in together. You will often see this indicated in my editorial comments and writings about the earthly, human invention of ‘superior aircraft’ having somewhere along the line of history ‘blended’ with an extraordinary, paranormal activity. That might be when an “extraterrestrial” entity came to Terraform the planet and seeded environmental variations that later inspired humankind to invent similar characteristics to and for themselves; ‘them‘ being parent to us and not ‘totallyalien,’ for that reason alone: Consequently, enter ‘gods,’ myths, legends, variousparanormalhappenings and, then,humankindtryingtoreplicatetheirownversionsofsightedobjectsandphenomena.
Though almost forty-five years have passed since the first publishing of the Hynek/Vallee book, and over five years for the Strieber book, nothing significant has come to the UFO arena. The UFO phenomena, like ghost tales, seem to be “a day late and a dollar short”; or, to quote Vallee’s repeat of Ira Einhorn Philadelphian poem: “It’sliketheneedleinthehaystack;wehavetheneedleandwearelookingforthehaystack!”
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:
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?
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 five to seven 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 five to seven 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 five to seven days of illness, the test group was not high risk (death rates were 3 percent), 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 and Azithromycin or doxycycline) nor administered treatment within the first five to seven 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 five to seven 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 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?
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 patients 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 five- to seven-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 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?
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 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.)
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?
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 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?
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 five to seven days of the disease with a cocktail that is safe and costs around $50?
FINAL QUESTIONS:
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?
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.
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?
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 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.
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
Excellent!!!! —-M.D.’s 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:
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?
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 five to seven 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 five to seven 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 five to seven days of illness, the test group was not high risk (death rates were 3 percent), 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 and Azithromycin or doxycycline) nor administered treatment within the first five to seven 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 five to seven 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 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?
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 patients 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 five- to seven-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 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?
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 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.)
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?
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 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?
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 five to seven days of the disease with a cocktail that is safe and costs around $50?
FINAL QUESTIONS:
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?
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.
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?
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 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.
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.
President Trump Proposes Use Of Hydroxychloroquineto Treat Covid 19
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.”
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