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White Paper on Hydroxychloroquine, by Dr. Simone Gold (Disappeared by the Blob)

White Paper on Hydroxychloroquine
Dr. Simone Gold, MD, JD

Introduction: General Consensus HCQ is safe………......................................................1

Safety Studies ...................................................................................................................4
2000-2020 (twenty years) study
FDA Database (fifty years)
CDC Statement
American Heart Association

Efficacy Studies (sample) ................................................................................................7
February 19, 2020
March 4, 2020
March 20, 2020
March 22, 2020
March 22, 2020
April 11, 2020
April 13, 2020
April 17, 2020
April 21, 2020
April 24, 2020
April 30, 2000
May 15, 2020
May 16, 2020
June 6, 2020
June 20,2020
June 29, 2020
June 29, 2020
June 30, 2020
July 3, 2020

Corruption of the Scientific Journals ..............................................................................10
Corruption of the Media .................................................................................................12
Censorship of the Public “Town Square” & Surgisphere ............……………………..13
Excessive & Punitive Regulations at the State Level & Off-Label Use ........................13
Misstatements at the Federal Level………………………………………………….…15
Why Has HCQ Been Maligned ……………………………….…………………….…19
Implications for the USA if restrictions on HCQ are not lifted immediately……….....21
Conclusion .....................................................................................................................28

This white paper is to draw the reader’s attention to the indisputable safety of
hydroxychloroquine (HCQ), an analog of the same quinine found in tree barks that George
Washington used to protect his troops. The modern version has been FDA approved for
65 years, has shown remarkable efficacy against SARS-CoV-2 and its use is being
wrongly restricted despite the immediate danger to the American people and the rest of the
We speak in support of immediately reversing the massive, irresponsible disinformation
campaign that is literally preventing doctors from dispensing HCQ, advocating as well
that it be made available over the counter in the United States. This is logistically easy to
do in a manner that ensures the supply and appropriate dispensation.
The purpose of this white paper is to dispassionately present the evidence regarding the
safety and efficacy of hydroxychloroquine and determine its proper role in the current
General Consensus that Hydroxychloroquine is Safe
Hydroxychloroquine (HCQ) has been FDA approved for over 65 years and has been used
billions of times throughout the entire world without restriction. For many decades it has
been given to: pregnant women, breastfeeding women, children, elderly patients, immune
compromised patients and healthy persons.
In the USA it is used most often in three situations: systemic lupus erythematosus (SLE),
rheumatoid arthritis (RA), and as malaria prophylaxis for travelers. These three situations
happen to represent three different types of populations.
Patients with SLE are immune compromised.
Patients with RA are elderly.
Travelers are younger and typically healthy.
Although all doctors can and do prescribe HCQ, because it is most commonly used for
SLE and RA, rheumatology specialists are the physicians in America who prescribe it the
most. Although it is in the safest category of medication and it is virtually always safely
used, the two most common possible complications fall under the specialty of cardiology
and ophthalmology.
So let us see what these three types of specialties say.
What do the Rheumatologists Say?
The physicians who prescribe HCQ the most are rheumatologists. Patients who need
HCQ typically are on the medication for years or decades. Therefore rheumatologists have
extensive experience with this medication. They make decisions daily regarding this
medication. They decide who can get the medication, is safe or unsafe, how much to give,
how often to dose, when to increase/decrease the dose, what testing if any should be done
prior to starting the medication, can the medicine be taken with other medicines, when to
stop the medication, what the side effects are. To help them with such decisions,
rheumatologists can check with their professional society: American College of
Rheumatology (ACR.)
The ACR website:
Hydroxychloroquine typically is very well tolerated. Serious side effects are
rare. The most common side effects are nausea and diarrhea, which often
improve with time. Less common side effects include rash, changes in skin
pigment (such as darkening or dark spots), hair changes, and muscle weakness.
Rarely, hydroxychloroquine can lead to anemia in some individuals. This can
happen in individuals with a condition known as G6PD deficiency or
In rare cases, hydroxychloroquine can cause visual changes or loss of vision.
Such vision problems are more likely to occur in individuals taking high doses
for many years, in individuals 60 years or older, those with significant kidney
or liver disease, and those with underlying retinal disease. At the recommended
dose, development of visual problems due to the medication is rare. It is
recommended that you have an eye exam within the first year of use, then
repeat every 1 to 5 years based on current guidelines.
Additional rare reports of changes in the heart rhythm have been reported with
the use of hydroxychloroquine, particularly in combination with other
medications. While monitoring for this risk is not typical in the office setting, it
has been indicated in hospitalized and critically ill patients to evaluate for
interactions with other medications.1
In other words the professional society of the physicians who prescribe this drug the most,
for years have said the following:
1. serious side effects are rare
2. visual changes can happen in people taking high doses for years
3. heart rhythm changes are so uncommon that there is no monitoring pre-use
In an interview with Dr. Mehmet Oz, prominent Los Angeles rheumatologist, Professor of
Medicine, Associate Director of the Rheumatology Dept. Cedars Sinai Medical Center Dr.
Daniel Wallace said the following:2
Dr. Oz: Is HCQ safe?
A: In 42 years of clinical practice I’ve treated several thousand lupus patients
and I would like to emphasize that all rheumatologists have a great deal of
experience with this drug. Regarding safety, since it came out 70 years ago,
several million patients have taken the drug. There have not been any reported
deaths from using this agent as monotherapy or taken only by itself.
Dr. Oz: Q: arrhythmia, heart issues?
A: It is a problem with CQ, which is its first cousin. And it was a problem with
HCQ in the 1950’s and 1960’s when doctors were using 2-3x its usual dose. In
the current recommended dose it really does not occur. 400 mg/day.
What do the Cardiologists Say?
Next let us consider the alleged complication that has dominated the news, which is a
potential heart problem. Those specialists are cardiologists. Heart rhythm problems are so
rare with HCQ that it is common practice not to do an EKG prior to starting the
medication. It’s the opposite of the truth to claim that there is a heart risk when the
specialty professional organization denies that, and when it is not what has been done for
decades prior to this pandemic. In addition, the American Heart Association has
demonstrated it is safe during Covid-19, which will be discussed below.3
Prominent Los Angeles cardiologist Dr. Daniel Wohlgelernter states:
Over the last 30 years I have had several hundred patient visits specifically to
discuss the toxicity of hydroxychloroquine. During that time, not a single
patient has been taken off of this drug for cardiac toxicity.4
The largest meta analysis published in 2018, revealed only 50 cardiac deaths attributed to
hydroxychloroquine in 60 plus years.5
The largest database analysis that examined this issue stated the following:
The results on the risk of severe adverse events associated with short-term (1
month) HCQ treatment as proposed for COVID-19 therapy are reassuring, with
no excess risk of any of the considered safety outcomes compared to an
equivalent therapy.6
What do the Ophthalmologists Say?
In an interview with Laura Ingraham, Dr. Richard Urso, ophthalmologist said this:
I have had several thousand patient visits to specifically discuss the toxicity of
this drug over my last 30 years. It’s a super safe drug. It’s safer than Tylenol,
aspirin, Motrin.7
There is no visual risk for short courses of HCQ. No one ever even suggests such a thing.
The people who use HCQ for a short period of time are travelers. Even the CDC website
does not suggest an eye exam. Rheumatologists and ophthalmologists who are familiar
with the rare visual problems all say the same thing. There is a rare risk of retinopathy that
is possible when a patient has been on the medication for many years. The risk of retinal
toxicity at five years of continuous use is zero. The risk of retinal toxicity at ten years of
continuous use is 1%. It gets higher after ten years of continuous use.”8
Toxicity can be seen in the macula and electrical conduction of the heart, after years
of use. Typically patients who have ingested 1/2 to 1 kilo in their lifetime become
more susceptible to these issues. Over a short-term course it is never seen.9
To put the amount that is needed to even possibly be at risk for retinopathy in perspective,
that is many years of using daily.
Safety Studies
It is self-evident that HCQ is safe from the fact that it has been FDA approved for 65 years
and has been used many billions of times all over the world and it is over the counter in
most of the world, certainly pre-2020. It is the #1 most used medication in India, the
second most populous nation on the planet with 1.3 billion people. If an American travels
to a location where malaria is endemic, per the CDC, they would start HCQ before they
left for their trip. There has never been an allegation that HCQ is not safe until 2020.
The only allegations of HCQ not being safe relate to a potential heart problem. The media
has stated this so often that many people, including physicians, think there is a potential
heart problem. However the evidence is overwhelming that HCQ is very low risk.
7 Dr. Richard Urso, ophthalmologist on Laura Ingraham July 10, 2020.
8 Dr. Daniel Wallace, rheumatologist on Dr. Oz April 8, 2020
9 Dr. Richard Urso, ophthalmologist on Laura Ingraham July 10, 2020
I. In the largest study to date on the subject, HCQ has been shown to not increase heart
(cardiac) risk.10 This study was across a multinational, distributed database network. It
studied all the data for 20 years, from January 9, 2000 – 2020 on patients who were
prescribed HCQ. The study had two goals: to understand the safety of HCQ by itself and
its safety when paired with the antibiotic azithromycin. This paper was authored by
scientists from 33 countries and companies across the world.
The paper is titled “Safety of hydroxychloroquine, alone and in combination with
azithromycin, in light of rapid widespread use for COVID-19: a multinational, network
cohort and self-controlled case series study.” In plain English, the authors found that over
a twenty-year period, looking at almost one million patients, those taking HCQ did not
have an increased risk of heart problems. It says:
This is the largest ever analysis of the safety of such treatments worldwide,
examining over 900,000 HCQ and more than 300,000 HCQ + azithromycin
users respectively. The results on the risk of serious adverse events associated
with short-term (1 month) HCQ treatment as proposed for COVID-19 therapy
are reassuring, with no excess risk of any of the considered safety outcomes
compared to an equivalent therapy.
II. The FDA database shows a total of 640 deaths attributable to HCQ over fifty years. To
put this in context “Each year the FDA receives over one million adverse event reports
associated with the use of drug products” “This concerns the entirety of HCQ use over
more than 50 years of data, likely millions of uses and of longer-term use than the five
days recommended for Covid-19 treatment.”11 The 640 deaths represented 0.034% of all
the deaths (1,910,212) attributable to medications.
10 The authors include
scientists from: University of Oxford, Fundacio Institut Universitari per a la recerca a l’Atencio
Primaria de Salut Jordi Gol I Gurina, University of Sao Paulo, Massachusetts General Hospital,
King Saud University, Harvard School of Public Health, Department of Veterans Affairs,
University of Utah School of Medicine, University of Zagreb School of Medicine, Columbia
University Medical Center, Islamic University of Gaza, New York Presbyterian Hospital, National
Institute for Health and Care UK, University of New Mexico Health Sciences Center, Erasmus
Medical Center, Vanderbilt University, University of Arizona College of Medicine, University of
Dundee Scotland, Institute of Medicine Sweden, Ajou University South Korea, National
University of Singapore, UCLA, Shanghai University of Traditional Chinese Medicine, Peking
Union Medical College, University of Melbourne, Janssen Research, Real World Solution,
Actelion Pharmaceuticals, Real-World Evidence Spain, AstraZeneca, RTI Health Solutions, Bayer
11 US Food & Drug Administration. FDA Adverse Events Reporting System (FAERS) Public
III. The CDC has an information sheet about HCQ. That sheet includes the following
Q: Who can take hydroxychloroquine?
A: Hydroxychloroquine can be prescribed to adults and children of all ages. It
can also be safely taken by pregnant women and nursing mothers.
Q: Who should not take hydroxychloroquine?
A: People with psoriasis should not take hydroxychloroquine.
Q: How should I take hydroxychloroquine?
A: Both adults and children should take one dose of hydroxychloroquine per
week starting at least one week before traveling… They should take one dose
per week while there, and for four consecutive weeks after leaving. The
weekly dosage for adults in 400 mg.
Q: What are the potential side effects of hydroxychloroquine?
A: Hydroxychloroquine is a relatively well tolerated medicine. The most
common adverse reactions reported are stomach pain, nausea, vomiting, and
headache. These side effects can often be lessened by taking
hydroxychloroquine with food. Hydroxychloroquine may also cause itching in
some people.
Q: How long is it safe to use hydroxychloroquine?
A: CDC has no limits on the use of hydroxychloroquine for the prevention of
malaria. When hydroxychloroquine is used at higher doses for many years, a
rare eye condition called retinopathy has occurred. People who take
hydroxychloroquine for more than five years should get regular eye exams.
IV. It is well established that there is no scientific basis for the claim that HCQ is risky on
its own. The only credible theory as to why there has even been a concern, is that since the
beginning, possible treatment options of COVID-19 have always included HCQ in
combination with the antibiotic azithromycin. Because each medication independently can
cause the same rare heart rhythm disturbance, there has been an academic concern whether
the two drugs could be risky when taken together. The particular heart rhythm problem is
called “QT prolongation” and it is a known side effect of hundreds of drugs. If the “QT
prolongation” is severe it can lead to a fatal rhythm problem called Torsades de Pointes.
Even though it is rare, this has been alleged to be of serious and frequent enough concern
that people should not use HCQ for Covid-19. The American Heart Association has now
answered this specific question. (April 29, 2020)
In the largest reported cohort of coronavirus disease 2019 to date treated with
chloroquine/hydroxychloroquine +/- azithromycin, no instances of Torsades
de Pointes or arrhythmogenic death were reported.13
In plain English: Taking HCQ even in combination with the antibiotic azithromycin does
not cause an increased risk of fatal heart rhythm problems.
The most comprehensive study on the subject was authored by Dr. Harvey Risch, MD,
PhD, Professor of Epidemiology at Yale School of Public Health, and published in
affiliation with the Johns Hopkins Bloomberg School of Public Health.14 Dr. Risch who
has 39,779 citations on Google Scholar, reviewed five outpatient studies, and shows with
specificity how the results have been misinterpreted, misstated and misreported. He notes
the following.
1. When examining the data on safety, Dr. Risch notes that early evidence of
safety was being ignored. “Lack of any cardiac arrhythmia events in the 405
Zelenko patients or the 1061 Marseilles patients or the 412 Brazil patients.”
2. When examining the data on safety, Dr. Risch demonstrates that the
negative conclusions drawn by various professional organizations are not
based upon science. “It is unclear why the FDA, NIH, and cardiology
societies made their [negative] recommendations about HCQ+AZM use now,
when the Oxford study analyzed 323,122 users of HCQ+AZ … that the
combination of HCQ+AZ has been in widespread standard-of-care use in the
US and elsewhere for decades … this use predominantly in older adults with
multiple comorbidities, with no such strident warnings about the use given
during that time.”15
There are only two things that must be considered regarding a medication: is it safe and
does it work? HCQ is amongst the safest of all prescription drugs in USA and that is why
across much of the world it is sold over the counter. And at a time when the world has
become seized with panic over a virus without a specific cure, the question of
effectiveness is almost moot. If a drug is safe and might work, and if there are no other
options, we must try it.
The safety record of HCQ is indisputable. But now seven months into the pandemic there
is overwhelming evidence accumulating that HCQ is also effective for Covid-19. There are
dozens of studies demonstrating its effectiveness from all around the world. From China
to France to Saudi Arabia to Iran to Italy to India to New York City to Michigan to Brazil.
This is not surprising. As far back as, chloroquine (CQ) the first cousin of HCQ and
previously known to be effective against SARS-CoV-1, was stated by China to be a
treatment for Covid-19.
• February 19, 2020 China: “The drug [chloroquine] is recommended to be
included in the next version of the Guidelines for the Prevention, Diagnosis,
and Treatment of Pneumonia Caused by COVID-19 issued by the National
Health Commission of the People’s Republic of China for the treatment of
COVID-10 infection in larger populations in the future.” 16
• March 4, 2020: France: “The first results obtained from more than 100
patients show the superiority of chloroquine compared with treatment of the
control group in terms of reduction of exacerbation of pneumonia, duration
of symptoms and delay of viral clearance all in the absence of severe side
• March 20, 2020: New York: 1450 patients. 1045 mild and not requiring
meds (all recovered), 405 treated with HCQ + AZM + Zinc of which six
were hospitalized and two died.18
• March 22, 2020: India: The country of India recommends HCQ
prophylaxis broadly.19
• March 22, 2020: China: “Among patients with Covid-19, HCQ could
significantly shorten time to complete recovery and promote the absorption
of pneumonia.”20
• April 11, 2020: France: All patients [treated with HCQ + AZM] improved
clinically except [two]… A rapid fall of nasopharyngeal viral load was
noted. … Patients were able to be rapidly discharged from IDU [Infectious
Disease Unit]…” 21
• April 13, 2020: NY: 54 long-term care/nursing home patients received
HCQ+ Doxycycline and only 5.6% died. (this population can have >50%
mortality) 22 23
• April 17, 2020: Brazil: Of 636 symptomatic high-risk outpatients, only
1.9% of those treated needed hospitalization vs., 5.4% of the untreated. 24
22 ABC News.
• April 21, 2020: 16 countries: “The difference in dynamics of daily deaths
is so striking that we believe that the urgency context commands presenting
the analysis …”25 26
• April 24, 2020: Iran: Hydroxychloroquine …can be potential treatment
• April 30, 2020: Saudi Arabia: “Chloroquine and hydroxychloroquine have
antiviral characteristics in vitro. The findings support the hypotheses that
these drugs have efficacy in the treatment of COvid-19.”28
• May 15, 2020: China: We found that fatalities are 18.8% in the HCQ
group, significantly lower than 47.4% in the non-HCQ group. These data
demonstrate that addition of HCQ on top of the basic treatments is highly
effective in reducing the fatality of critically ill patients of Covid-19 through
attenuation of inflammatory cytokine storm. Therefore, HCQ should be
prescribed as a part of treatment for critically ill Covid-19 patients, with
possible outcome of saving lives. 29
• May 16, 2020: France: 1061 Covid-positive patients treated with
HCQ+AZM “no cardiac toxicity was observed” and “good clinical outcome
and virological cure were seen in 92%.30
• June 6, 2020: France: “In conclusion, a meta-analysis of publicly available
clinical reports demonstrates that chloroquine … reduces mortality by a
factor 3 in patients infected with Covid-19.”31
• June 20, 2020: India: “Consumption of four or more maintenance doses of
HCQ was associated with a significant decline in the odds of getting
infected… This study provides actionable information for policymakers to
protect healthcare workers at the forefront of Covid-19 response.”32 33
• June 29, 2020: Portugal: The odds ration of [Covid-19] infection in patient
with chronic treatment with HCQ is half.34
• June 29, 2020: Detroit: “In this multi-hospital assessment, when
controlling for Covid-19 risk factors, treatment with HCQ alone and in
combination with AZM was associated with reduction in Covid-19
• June 30, 2020: NYC: 6493 patients who had laboratory confirmed Covid-
19 with clinical outcomes between March 13-April 17, 2020 who were seen
in 8 hospitals and 400 clinics in the NYC metropolitan area.
“Hydroxychloroquine use was associated with decreased mortality.”36
• July 3, 2020: NY: Covid-positive patients treated with HCQ + AZM +
Zinc vs. untreated.37
hospitalized: treated 2.8% vs. untreated 15.4%
death: treated 0.7% vs. untreated 3.5%
No cardiac side effects
5x less all-cause deaths
As discussed in the Safety section, the most comprehensive study on the subject was
authored by Dr. Harvey Risch, MD, PhD, Professor of Epidemiology at Yale School of
Public Health, and published in affiliation with the Johns Hopkins Bloomberg School of
Public Health.38 He notes the following.
1. When examining data on efficacy, Dr. Risch notes that the French studies
were routinely disparaged as not being randomized, controlled and doubleblinded.
(Although that is the gold standard in research, it is of course
impossible in the beginning stages of investigating a new disease.) However
Dr. Risch notes that the results were so stunning as to far outweigh that issue.
“The first study of HCQ + AZM showed a 50x benefit vs. standard of care.
This is such an enormous difference that it cannot be ignored despite lack of
2. When examining data on efficacy, Dr. Risch notes that evidence against
HCQ when it is used alone is irrelevant,40 as it has been known since
Feb-March that HCQ must be used in combination therapy.41
Four Levels of Obfuscation Used to Disparage This Remedy
39 Gautret P, Lagier J-C, Parola P, et al. Hydroxychlorquine and azithromycin as a treatment of
Covid-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agent 2020 Mar
Corruption of the Scientific Journals
It is well known that The Lancet and The New England Journal of Medicine (NEJM)
had to retract their studies. It was well documented in a series published in The Guardian
starting with the headline: “The Lancet has made one of the biggest retractions in modern
history. How could this happen?”42 The sheer number and magnitude of the things that
went wrong or missing are too enormous to attribute to mere incompetence.
The data upon which these studies were based were so ridiculously erroneous that it only
took two weeks for an eagle-eyed physician to publicly demand an explanation.43 What’s
incredible is that the editors of these esteemed journals still have a job – that is how utterly
incredible the supposed data underlying the studies was. The company that “gathered” the
alleged data (Surgisphere) is now wiped clean from the Internet.
The Lancet and The NEJM have at least been exposed, but the third premier journal, as
yet unexposed, is the Journal of the American Medical Association (JAMA.) While the
first two journals published fraudulent studies, the JAMA study seems criminal in its utter
disregard for human life.
The worldwide fallout from these three journals was fast and furious:
USA Today:
“Coronavirus Patients who took HCQ had higher risk of death, study shows.”44
The World Health Organization ordered nations to stop using HCQ and CQ,45
WHO Chief Tedros suspended trials being held in hundreds of hospitals across
the world,46
The EU governments France, Italy, and Belgium banned HCQ for Covid-19
Worldwide ridicule was heaped upon the President of the United States.48 49
One can speculate how it is possible that the #1, #2, and #3 most famous medical journals
in the world have jointly, erroneously, and virtually simultaneously, condemned HCQ/CQ.
Here is one theory.
Dr. Dousty-Blazy, the former French Health Minister, Under Secretary General of UN,
and candidate for Director of WHO has publicly stated that The Lancet and the NEJM
Editors admit to being pressured by pharmaceutical companies to publish certain results.
The Lancet’s boss … said … the pharmaceutical companies are so
financially powerful today and are able to use such methodologies as to have
us accept papers which … in reality manage to conclude what they want ... I
have been doing research for 20 years of my life. I never thought the boss of
The Lancet could say that. And the boss of the NEJM too. He even said it
was ‘criminal.’50
In the case of the JAMA study, the scientists gave up to 2.5x lethal dosage of the
medication.51 Unsurprisingly so many patients died they halted the study early. They also
cherry-picked patients and had no proof that there was the standard ethics oversight of the
study. JAMA knew of these problems and published the study anyway. Various scientists
have demanded its retraction, and even now, with civil and criminal investigations into
these deaths, the study is still is not retracted. And the headlines around this study blame
the drug, not the fact that old, sick, hospitalized, compromised patients were given toxic
dosages of a drug.
This is a mockery. These journals did not publish science, but instead published fiction or
evidence of a crime.
Corruption of the Media
In addition to the corruption of the Journals we must note the widespread disinformation
campaign as regards this safe and effective medication. While we don’t blame individual
journalists or publishers, in the aggregate, it is breathtaking that the overwhelming news
regarding HCQ is positive and yet it is almost impossible to find any good news in the
American media.
For example at approximately the same time The Lancet and the NEJM and JAMA
published their retracted and possibly criminal studies, one of the oldest and most
prestigious Journals in the world, the Indian Journal of Medical Research published very
good news regarding HCQ.52 Few have heard of this study because the mainstream press
has ignored it.
Another example is the inexplicable delay in the publication of the Detroit study. This
study was completed May 2, 2020.”53 The Detroit study was not published until just
before the July 4th Holiday and there was also no pre-publication press conference hinting
at the good news. In normal times, a lag of seven weeks would be acceptable, but the
Detroit results were showed a half mortality rate and everything regarding Covid-19 era is
published at warp speed. Why the delay?
Censorship of the Public “Town Square”
The clearest example of physician free speech censorship is what happened to James
Todaro, MD.54 Dr. Todaro, who up until these events was a mere private citizen, tweeted
his thoughts about HCQ including a link to a public Google doc six days before the
President endorsed HCQ. Dr. Todaro’s apolitical scientific commentary was his opinion of
a scientific study that appeared to be fabricated, despite being published in a world-class
journal. It turns out Dr. Todaro was so spot-on correct, that the study, which unfortunately
had enormous worldwide influence, was retracted which is exceedingly rare. But before
the public could read Dr. Todaro’s prescient words, the President happened to endorse
HCQ, and Google scrubbed the document within hours.
And by scrubbed we mean that Google didn’t want you to think it was missing, they
wanted you to not know such a thing ever even existed. This is how is happens.
First, Dr. Todaro has already learned that he will be censored, so he decides to bypass the
censor by not even attempting to get a mainstream news source to publish his story about
HCQ. He has accepted that even though his story is exactly the kind of counter-culture
story that used to be sought after by journalists, those days are gone.
So Dr. Todaro self-publishes a document that he wrote and puts it out for public view, on
a site that calls itself content-neutral: Google. Google claims it is a platform and not a
publisher, which is a huge distinction. Platforms are just the vehicle to get the words from
point a to point b. Publishers are responsible for content. If Google is a platform, which it
represents itself to be, including before Congress, then it should not censor non-salacious
content written by a scientist about science.
Censorship is evident for those who wish to see it.
Excessive & Punitive Regulations at the State Level & “Off-Label” Prescribing
There is obviously a tremendous disinformation campaign going on in the United States of
America claiming that HCQ is neither safe nor effective. This is quite remarkable for a
medication that has been FDA approved for 65 years and having already been dispensed
billions of times all across the world with only 57 serious adverse events (heart) noted by
the FDA in their own database over the past fifty years. In many countries it is available
over the counter, like aspirin and Tylenol.
Nonetheless, with the negative pressure being applied, state Governors have ordered,
through their state licensing boards that physicians stop using it, and pharmacists stop
dispensing it. Their wording is often more cautious, but doctors are told that they could be
charged with “unprofessional conduct” (a threat to their license) or be “sanctioned” if they
prescribe. First we need to understand how prescriptions have been done for decades.
Once approved by the FDA, any physician can prescribe any prescription medication in
the USA, for any reason.55 This is significant in that a drug is not approved for a specific
diagnosis; a drug either makes it through the years-long approval process or it does not.
That means a medication can be used “on-label” (the reason it was approved) or “offlabel”
(other reasons that have never received FDA approval.) It costs a lot of money for
the pharmaceutical company to gain another “on-label” use, so once a drug is approved for
any use, it is typically used for many reasons. Those additional reasons are called “offlabel.”
As a practical matter “off-label” use accounts for about 20% of prescriptions. It is a daily
occurrence. For example, it is off-label to give morphine as a pain medication for children.
Indomethacin (an anti-inflammatory) was discovered in the 1970’s to work for a specific
heart condition in newborns and is the standard of care for that condition (PDA) even
though it has never been approved for this diagnosis. The very popular anti-nausea drug
“Zofran” is given routinely (doctors call it the “bacon” of drugs) for virtually any type of
nausea but it only has two very specific on-label indications: post-operative and
chemotherapy induced nausea.
Another very common example is aspirin, which is not indicated for heart (coronary artery
disease) prophylaxis in diabetics and yet it is the formal recommendation and standard
practice by cardiologists.56 It has been estimated that 73% of off-label use had low or no
scientific support.57 Pediatric antidepressant drugs are typically used off-label and are
prone to error.58
There is a complete disconnect between physicians and everyone else on the subject of
off-label use.59 While almost all members of the public have benefited from “off-label”
use of drug, many may not be focused on the distinction between “off-label” and “onlabel”
usages. This is logical as patients rely on and know physicians are personally and
56 Regulating off-label drug use--rethinking the role of the FDA. Stafford RS N Engl J Med. 2008
Apr 3; 358(14):1427-9.
57 Off-label prescribing among office-based physicians. Radley DC, Finkelstein SN, Stafford RS
Arch Intern Med. 2006 May 8; 166(9):1021-
58 Pediatric antidepressant medication errors in a national error reporting database. Rinke ML,
Bundy DG, Shore AD, Colantuoni E, Morlock LL, Miller MR J Dev Behav Pediatr. 2010 Feb-
Mar; 31(2):129-36.
59 U.S. adults ambivalent about the risks and benefits of off-label prescription drug use: Harris
Interactive Website.
professionally obligated (and subject to much oversight and malpractice litigation), to do
what is in the patient’s best interest.
Exploiting the public’s understandable lack of focus on the non-distinction between offlabel
and on-label has contributed to the public’s confusion regarding HCQ for Covid-19.
From the physician’s perspective if a drug is FDA approved and safe it is within the
physician’s armamentarium. And from the physician’s perspective, is highly suspect that
that rule should change in the middle of a pandemic and without any legislative discussion
or regulation whatsoever, let alone sound science to support the same. It has never
happened that a state has threatened a doctor for prescribing a universally accepted safe
generic cheap drug off-label.
Although the states are the entities that empower physicians to prescribe, examples of
abusive state actions will be in the next (federal) section because the states commonly
blame the FDA (federal) for their newly aggressive regulations. But please note that many
doctors have personally attested to the four harms caused by these Governors/State
Medical Boards.60
1. doctors have been sanctioned, disciplined, interrogated
2. pharmacists have been empowered to over-ride physicians
3. patients get sicker and die
4. physicians self-censoring due to fear of retribution
Misstatements at the Federal (FDA) Level
Hydroxychloroquine is safe as a matter of fact, as demonstrated above. It is also
considered “legally” safe as a matter of law as it is FDA approved for 65 years and doctors
have been freely prescribing it in all that time until Covid-19. Contradicting its own
policy, we believe for the first time in its history, the FDA has made statements that have
caused states to restrict its use. While the right to prescribe is granted by each state, the
states are informed by the FDA, and in reliance on the FDA, here are examples of overreaching
by many states.
Updated June 16, 2020
The Food and Drug Administration (FDA) has announced the removal of
Emergency Use Authorizations (EUA) for chloroquine (CQ) and
hydroxychloroquine (HCQ) to treat COVID-19. The announcement follows
the FDA’s determination that CQ and HCQ are unlikely effective treatments
for COVID-19. In addition, the FDA further indicated the potential benefit
does not outweigh the potential serious cardiovascular events and other
adverse effects that can be caused by CQ and HCQ.2
Based on this information, the Arkansas Department of Health has updated its
guidance related to hydroxychloroquine and chloroquine. The utilization of
CQ and HCQ for treatment of COVID-19 should be avoided in both
outpatient and hospitalized settings. HCQ that has been distributed through
the Strategic National Stockpile is no longer authorized under the EUA to
treat hospitalized patients for COVID-19, unless they had already started
Chloroquine and hydroxychloroquine should be administered, prescribed and
dispensed for FDA approved medical conditions under supervision of a
patient’s healthcare provider.
Statement Regarding Improper Prescribing of Medications Related to Treatment for Novel
Coronavirus (COVID-19)
Several states have recently issued emergency restrictions on how the drugs can
be dispensed. Many require that medications be prescribed and dispensed only
to patients with a legitimate and current medical condition. Further, the FDA
recently issued an Emergency Use Authorization to allow for the use of
hydroxychloroquine sulfate and chloroquine phosphate products donated by the
Strategic National Stockpile for certain hospitalized patients with COVID-19.
DCA, the Medical Board of California, and the California State Board of
Pharmacy remind health care professionals that inappropriately prescribing or
dispensing medications constitutes unprofessional conduct in California.
Prescribers and pharmacists are obligated to follow the law, standard of care,
and professional codes of ethics in serving their patients and public health.
Here are recommendations, first distributed by The American Society of Health-
System Pharmacists (ASHP) to its membership, which may serve as a general guide
for healthcare professionals regarding the receipt and dispensing of prescriptions for
hydroxychloroquine, which can be applied to other COVID-19 investigative
1. Continue to fill prescriptions for existing patients who are being prescribed
these medications for FDA-approved indications on chronic therapy.
62 Author has original copy
2. For new prescriptions, prescribers should be cognizant that
hydroxychloroquine use in COVID-19 patients is not the standard of care.
Pharmacists should verify and document diagnosis with the prescriber or
prescriber’s agent and limit to a 30-day supply of medication with the drug
frequently on back order at this time for prescriptions with an FDAapproved
3. Due to limited supply, reserve hydroxychloroquine for patients with
known autoimmune disorders and those ill enough to be hospitalized for
Please note that the Colorado State Board of Pharmacy, the Colorado Medical Board and
the Colorado Nursing Board have the authority to discipline their corresponding licensees
who fail to meet their corresponding generally accepted standards of practice.
DPH strongly advises against off-label use of hydroxychloroquine and
azithromycin in the outpatient setting for COVID-19 prophylaxis or treatment.
New Hampshire:65
Chloroquine, hydroxychloroquine, and albuterol inhalers shall be subject to
the following controls, restrictions, and rationing: a) Outpatient prescriptions
for patients not already established on chloroquine and hydroxychloroquine
shall be limited to a 30-day supply. b) No prescriptions of chloroquine or
hydroxychloroquine shall be issued or dispensed as prophylaxis treatment for
COVID-19. c) Prescribing providers, when issuing a prescription in any form
for chloroquine or hydroxychloroquine, must document an indication for all
patients, including patients already established on these medications. d) For
albuterol inhalers, prescribing providers shall limit prescriptions to one inhaler
with up to three refills for all new prescriptions to treat respiratory symptoms
of COVID-19. e) For all prescriptions of albuterol inhalers, pharmacists shall
conduct a prospective drug utilization review to ensure adherence to asthma
controller or maintenance medications, and counsel patients that are noncompliant
and over-utilizing rescue inhalers. 2. This Order shall remain in
effect until the State of Emergency declared by the Governor is terminated, or
this Order is rescinded, whichever shall happen first.
New York:66
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, and
any permitted prescription is limited to one fourteen day prescription with no
Updated 6/15/2020
Oregon's pharmacy board put out a new rule on 6/15:
"Prescription orders for chloroquine or hydroxychloroquine for the prevention or
treatment of COVID-19 infection may only be dispensed if written for a patient
enrolled in a clinical trial by an authorized investigator."
And the board cites the FDA revocation of the EUA:
NEED FOR THE RULE(S): On 6/15/2020, the FDA revoked the emergency use
authorization (EUA) that allowed for chloroquine phosphate and
hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used
to treat certain hospitalized patients with COVID-19 when a clinical trial was
unavailable, or participation in a clinical trial was not feasible. The agency
determined that the legal criteria for issuing an EUA are no longer met. Based on
its ongoing analysis of the EUA and emerging scientific data, the FDA
determined that chloroquine and hydroxychloroquine are unlikely to be effective
in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of
ongoing serious cardiac adverse events and other potential serious side effects, the
known and potential benefits of chloroquine and hydroxychloroquine no longer
outweigh the known and potential risks for the authorized use. Furthermore,
hydroxychloroquine continues to remain on the FDA's drug shortage list.
It bears repeating that to be FDA approved, a drug has to go through years of testing. To
be FDA approved for 65 years is an overwhelming testimonial to a drug’s safety and
efficacy. There is no need for additional government intrusion.
Only a handful of states let doctors continue to be doctors. Florida did not get involved in
the politicization of a drug. Florida spoke loudly and clearly by adding nothing additional
to the already massive amounts of drug regulations by the Governor, the state medical
board and the state pharmacy board.
Why Is HCQ Being Maligned?
COVID-19 is an acronym for SARS-CoV-2. It is so named because it turns out there was
a SARS-CoV-1. Reading the scientific literature related to the first SARS is so eerily
similar that excerpts are copy/pasted on the next page. In 2002 there was a new
coronavirus, originating in China, which rapidly spread to dozens of countries, within a
few months, leading to worldwide efforts to contain it. The scientists discovered that CQ
had a strong antiviral effect on this SARS-CoV virus, whether the CQ was used before or
after infection. It was concluded that CQ had both prophylactic and therapeutic use.
The study “Chloroquine is a Potent Inhibitor of SARS Coronavirus Infection and Spread”
by Vincent, Bergeron, Benjannet, et. al., was published by the official publication of the
National Institutes of Health when Dr. Fauci was NIH Director:68 Given that CQ was
demonstrated to be very effective against a 78% identical coronavirus less than 15 years
ago during a very similar situation, it is very curious that there was a multinational effort
to restrict it starting in mid-January. (CQ is a precursor to the more modern HCQ. We now
use HCQ in the USA. But studies of CQ are as reliable as studies of HCQ.)
On January 13, 2020 France quietly changed the status of HCQ from its years long overthe-
counter status to “List II poisonous substance.” 69 This was an unprecedented
demotion. And in the USA: “Dr. Anthony Fauci said Wednesday that data shows HCQ is
not an effective agent for the coronavirus, disputing use of the drug to fight the deadly
virus even as President Donald Trump touts it as a potential cure.”70
It is unclear when Dr. Fauci came to believe the opposite of what the NIH published when
he was the NIH Director. What we do know is that 70,000-100,000 excess American lives
have been lost due to lack of access to HCQ. So why did a medication that had been over
the counter for decades, suddenly but quietly get pulled from the shelves, in the midst of a
pandemic, due to a virus that is so similar it shares a name?
It is well known that newly patented drugs can be extremely profitable if there is demand
and no other supply. The demand for Gilead’s Remdisivir, which is used late in the
disease, obviously will plummet if the disease is stopped by HCQ early. Remdisivir is
sold for $3200-$5700 per treatment and the federal government has already purchased all
or most of it.71 The generic HCQ is ~$10 per treatment.
Implications for the USA if restrictions on HCQ are not lifted immediately.
The safety of HCQ is so well established that it should have been over the counter decades
ago, and in fact that is how it is in much of the world. The process to move a medication
from prescription to over the counter in America is typically driven by a pharmaceutical
company that has a profit motive: is a safe, well-established drug more profitable, at this
time, over the counter? That is how drugs such as Zantac, Pepcid, Zyrtec, Allegra, Aleve,
Benadryl, Minoxidil and nicotine patches and others came to be over the counter.
HCQ is safe but there’s no profit motive to move it to over the counter, as there have been
no general usage indication in America. It would languish on the shelves. So it sits in the
armamentarium of prescription drugs, and quite frankly, no one gave it much thought prior
to this pandemic. However, the landscape has changed, and now there is an urgent impetus
to make it readily available to the American people.
It is interesting to note that many over the counter drugs, probably the majority, are less
safe than HCQ. For example Tylenol, and aspirin are listed as more risky.72 Most doctors
would attest to the frequent problems people have with Motrin/Ibuprofen/Aleve. Tylenol
toxicity is the most common reason for liver transplant in the USA and antiinflammatories
account for an enormous number of GI bleeds/pain/distress.
If the disinformation campaign regarding HCQ weren’t so complete, from the scientific
journals, to the media, to the state medical boards to the FDA, this would not really
matter. Individual physicians who are innovators and early adopters would have moved
first, prescribing HCQ off-label, just as physicians already do 20% of the time, and it
would have caught on rapidly. However, the disinformation campaign blocked off-label
use, and now we are in a pandemic with a safe and effective drug that doctors inclined to
prescribe and patients inclined to take, cannot access.
As a result, not only are patients not being treated promptly, effectively, and safely, some
patients die. And as the fear of the pandemic has overtaken the virus itself and it is
impossible to change public and physician opinion quickly enough to save lives, we must
make the medication available to the public directly.
Dr. Harvey Risch, MD, PhD, Professor of Epidemiology at Yale School of Public Health
and published in affiliation with the Johns Hopkins Bloomberg School of Public Health.73
Dr. Risch who has 39,779 citations on Google Scholar, notes that:74
“US cumulative deaths through July 15 are 140,000. Had we permitted HCQ
use liberally, we would have saved half, 70,000 and it is very possible we
could have saved 3/4, 105,000.”
74 Interview with the author July 15, 2020
It is relevant that the problem that the USA has with accessing hydroxychloroquine is a
first-world problem. Curiously the people who cannot get HCQ typically live in firstworld
democracies. Speaking generally, HCQ or its progenitor CQ, was freely available
over the counter in most of the world Africa, Asia, South America, even Canada and
Mexico, prior to Covid. Long before President Trump endorsed HCQ on March 20, 2020,
the drug was quietly removed from pharmacy shelves in Canada and it was banned
outright in France. These two actions were taken in January 2020. It is speculation as to
why but one must consider who benefits if HCQ is not accessible.
It cannot be overlooked that right now, all over the world, patients who want to buy HCQ
simply do. Iran, Costa Rica, Italy, Panama; many others. Here is a photograph of a typical
pharmacy in Indonesia taken on July 16, 2020.75
No matter the reason, there is an obvious relationship between access to HCQ and
mortality rates from Covid-19. While it is true that such a relationship does not prove
cause/effect, but it is also true that it would be lunacy to assume no relationship.76
75 @Smackenziekerr July 17, 2020
76 AAPS vs. FDA
Country by country data is also available and access to HCQ is strongly linked to lower
mortality.77 We can see that even very poor countries have much lower case fatality rates
than wealthy countries, which of course, is typically the opposite of what we would expect
of a respiratory disease that could end up in an ICU admission. Kazakhstan, Bangladesh,
Senegal, Pakistan, Serbia, Nigeria, Turkey, Ukraine, Honduras … the list goes on.
Wealthier democracies or countries with especially abusive HCQ protocols such as are
doing terribly: Ireland, Canada, Spain, The Netherlands, UK, Belgium, France ... Of note,
Italy and Spain switched mid-stream and now HCQ is easily available.
The limitation or outright ban on HCQ worldwide has begun to crack. It will soon collapse
because the evidence of its safety and efficacy is so overwhelming. The countries that
have less flexibility to tolerate fatal policies have already reversed themselves. South of
us, Honduras, Panama, Costa Rica have, or earlier had, made HCQ available. Brazil is
trying but faces many of the same political problems as the USA. Some countries have
started going door to door to facilitate its availability.78
In Honduras their national policy now is: “The patient that presents for the first time to a
First Level of Care facility, if so, treatment should be started with: Acetaminophen,
Hydroxychloroquine 400 every 12 hours, Ivermectin, Azithromycin, Zinc …”79
Panama reversed course regarding HCQ and many countries in South and Central
America are following suit:80
Evaluating new evidence around the therapeutic options for COVID-19,
specifically the use of HCQ and the Lancet journal withdrawing its
publication on this topic. The Ministry of Health communicates that Circular
No. 118-DGSP is null and void, establishing directives for immediate
compliance regarding the use of HCQ and / or azithromycin. Leaving the
therapeutic option for prescription according to medical criteria. Soon we will
be sending a treatment guide for Covid-19 patients.
78 Conversation author had with Dr. Sanchez, head of FDA Honduras July 10, 2020.
79 Conversation author had with Maria Dolores Aguero Ministra De Relaciones Exteriores July 9,
80 Dr. Luis Francisco Sucre Mejia – Ministro de Salud
In France, HCQ had been sold over the counter for many years, but on January 15, 2020,
then Health minister Buzyn reclassified it as “list II of poisonous substances.” Three days
after Trump endorsed it, the next Health Minister Veran said that HCQ was only to be
usedfor severely ill hospitalized patients and could not be used early or prophylaxis
(three). Then two months later he terminated using it at all. All this time, esteemed
virologist Professor Raoult continued his clinical trials and in his hospitals the mortality
rate was 0.52% compared to the rest of France 19.12%. Because this was so mishandled,
resulting in so many unnecessary deaths, the former French Prime Minister and two
Ministers of Health are now being criminally investigated.81
Former French Prime Minister, health ministers to be investigated for
pandemic response” A French court will investigate former French Prime
Minister Edouard Philippe and two health ministers following complaints
about the government's handling of the coronavirus pandemic, Prosecutor
General François Molins said today. Philippe, former Health Minister Agnès
Buzyn and outgoing Health Minister Olivier Véran will have to respond to
accusations of abstaining from fighting a disaster.
In The Netherlands, Dr. R. Elens, has filed suit due to his being blocked from prescribing
HCQ, which is contrary to his lifelong practice as a physician.82 He was sanctioned and
could face a fine of Euro150,000. He filed this petition to clarify the status of HCQ and
will pursue to The Hague if necessary as a crime against humanity.
As in all battles of good vs. evil, when America falters, the world collapses.
This white paper is to draw the reader’s attention to the indisputable safety of HCQ,
remarkable efficacy of HCQ against SARS-CoV-2, and the worldwide political storm that
has resulted in its use being restricted. We speak in support of it being made available over
the counter in the USA due to the inability of Americans to access it, whether they need it
for treatment or to manage their fear.83
The virus is known to be asymptomatic or mild the vast majority of the time, but in people
with multiple co-morbid conditions, rarely it can be deadly. Because so much was
unknown in the beginning, the most cautious approach was taken. However, now that we
know the facts, it has proven impossible to dislodge the fear that was implemented.
At this time, disinformation and therefore resultant fear have a firmer grip on Americans
than reality. And thus Americans who need a life-saving medication cannot get it either
due to their own physicians’ reluctance, their pharmacies regulating against the same, their
state medical boards threats, the media disinformation, and/or due to certain sectors of the
federal government’s own anti-HCQ statements.
Some people question if making HCQ over the counter would change anything, as there
has been such negative coverage. The answer is like all things in life: there are innovators,
early adopters, early majority, late majority and laggards. What has gone wrong in this
instance is that innovators and early adopters have been stymied. Once people are free
again to make their own choices, they will, and society will normalize over about a month.
Once Americans know they can buy a safe, cheap, generic, life-saving medication, should
they need it, calm and rationality can be restored, not just to America, but throughout the
world. A person who suffers from an occasional migraine headache but who has the
migraine medicine at home or in her pocket, in case she needs it, is a person who feels
safe and comfortable going about her daily routine. If she does not have that prescription,
she may limit herself a lot or a little, and either way, she is fearful of what is around the
At the very least, the efficacy “assassination” of HCQ must be reversed immediately.
Doctors must be able to prescribe HCQ as a treatment and as a prophylaxis. It is
absolutely unacceptable that doctors are not being able to communicate responsibly and
with compassion with their patients. That must be remedied. Period.
Americans do not need to be afraid. Instead, they need to be empowered. Their physicians
should not be prevented from upholding their Hippocratic Oath and healing their patients.
Instead, they must be permitted to practices sound and safe medicine. Patients and their
doctors must be able to discuss the options for optimal care and treatment and the patientphysician
relationship must take precedent.