Trump’s 63 Million Doses of Hydroxychloroquine Could Have Been Great for America
Following Trump’s proposal, HCQ came under an unwarranted full-scale attack from federal officials, the press, “fact-checkers,” and university professors.
BY DAVID GORTLER
View original article at Brownstone.org.
Note—the following is an excerpt from Dr. Gortler’s article. The full-length version can be found here.
Early in the pandemic, President Donald Trump and White House senior official Peter Navarro arranged the donation of 63 million doses of hydroxychloroquine (HCQ) to America’s strategic drug stockpile to combat Covid-19. The government began securing HCQ in March 2020, after Trump, on the advice of his medical and scientific advisors, lauded HCQ as “very encouraging,” “very powerful,” and a “game-changer.” While HCQ (and its structurally similar analogue chloroquine) was not FDA-indicated for Covid-19, it was well-known to have specific off-label pharmacological functionality for preventing viral particle entry into cells, chemical derivatives of which have been utilized for antiviral use as far back as 1934.
Following Trump’s proposal, HCQ suddenly came under an unwarranted full-scale attack from federal officials, the press, so-called “fact-checkers,” and university professors. Many of the attacks contained outright falsehoods about HCQ’s pharmacology and safety or Trump’s endeavor to make HCQ available to eligible patients.
The FDA initially issued an emergency use authorization (EUA) for HCQ in March 2020, but withdrew authorization on June 15th 2020, stating the drug is “unlikely to be effective in treating COVID-19 for the [EUA] authorized uses.” Around the same time, the FDA also wrote a methodologically questionable report criticizing HCQ’s safety. The FDA’s narrative was based on preliminary and time-compartmentalized findings, and not a reflection of historical safety or based on the appropriate clinical use of HCQ dosing, prescribing, timing, and duration. The FDA then seemed to label its findings as conclusive, figuratively slamming the door shut on the consideration of new findings.
FDA Hydroxychloroquine Safety Assessment Based on: Known Overdoses, and Clinically Unsupervised Uses
According to its uncharacteristically brief 15-page safety review memorandum of HCQ published on May 19, 2020, the FDA considered data from the National Poison Data System (NPDS) which means it seems to have included the use of non-pharmaceutical-grade and/or self-administered HCQ and/or overdose data in its clinical evaluation.
Obviously, overdose or any non-medically supervised, self-diagnosis, and/or self-dosing of any prescription drug has a higher potential to result in adverse events, especially because the antiviral dose/duration of HCQ and/or chloroquine were not immediately obvious to the lay public. Of note, “if it bleeds it leads”-type sensationalized news reporting caused anxious and desperate Americans with incomplete or incorrect transmission and mortality information to go so far as to self-administer “fish tank” chloroquine-containing cleaning products of containing other chemicals to treat themselves from possible Covid-19 exposure. This led to severe illness due to the ingestion of toxic ingestions or overdoses, sometimes up to the point of death.
Heavy Reliance on the FDA’s Adverse Event Reporting System Database
In its report, the FDA also referenced its Adverse Event Reporting System (FAERS) which according to Table 6 only contained around 256 applicable adverse event reports over a five-month period in the entire world when administered for Covid-19. Of note, most of the reports cited by the FDA included doses which were either unknown and/or were anywhere from 2x to 6x the recommended maximum maintenance dose of HCQ for any clinical indication per FDA and manufacturer’s dosing recommendations. On top of that, it appears that the FDA gave no consideration to HCQ base/salt formulations or critical weight-based dosing of HCQ (on a mg/kg basis) as it did not appear to investigate or report patient weights. It is unknown if any organ function assessments were considered as part of their safety collection or evaluation – an important consideration since HCQ is hepatically metabolized and renally excreted, with dosage adjustments potentially needed for out-of-range liver or kidney function.
These and other important mitigating factors would have been needed for a suitable evaluation of HCQ safety by the FDA.
FDA Seemed to Include Well-Known Drug-Drug Interactions and Unknown Quality Likely from Rogue Internet Pharmacies:
Well- established drug-drug interactions, some established as far back as the 1980s, occurred in individuals who obtained HCQ by circumventing normal patient/prescribing channels. In addition to the incorrect/excessive dose/durations used, the FDA’s report details how HCQ appeared to have been dispensed from rogue overseas pharmacies which have a history of producing consumer drugs with poor quality and toxic contaminants.
In its report, the FDA showed that the majority of all adverse event cases (69% of the 331 total HCQ safety reports) involved males with a median age in the early 60s, yet the FDA used those negative findings to recommend against the use of HCQ in every age group.
On top of that, Page 7 of the report showed most of the 109 serious HCQ cardiac adverse event cases cited by the FDA also directly contraindicated well-established FDA and/or manufacturer dosing guidelines for HCQ.
Specifically:
92 of the 109 serious cardiac cases (84%) reported concomitant use of at least one other medication that prolongs the QT interval.
75 (69%) of cardiac cases specifically reported concomitant use of azithromycin.
22/25 [88%] of the fatal cases reported use of a concomitant QT-prolonging medication.
In other words, the FDA included well-known, clinically unsound, long-established, drug-drug interactions, contraindicated uses, and/or prescribing errors in denigrating HCQ’s safety.
It is fair to say that 84% of cardiac adverse events (and possibly the majority of other reported HCQ adverse events listed in the FDA’s memorandum) could have been prevented by clinical patient education, appropriate clinical supervision, and the appropriate pharmacist dispensing/counseling of a medication of known quality from a US pharmacy, including cardiac assessments and the appropriate checks for drug-drug interactions. Even more adverse events could have likely been prevented with a brief cardiac history evaluation and/or an electrocardiogram. In fact, Lopinavir/ritonavir (Paxlovid), used to treat Covid, has an established QT prolongation effect like HCQ, but since warnings about drug-drug interactions are well-publicized and Paxlovid is dispensed under physician/pharmacist supervision, reported cardiac adverse events are uncommon, avoiding cardiac and other safety concerns.
No one drug is ever appropriate for every single person, and not everyone is eligible to be dosed with HCQ for underlying reasons including organ function, cardiac conditions, and/or the risk for established adverse events. However, drug-drug interactions and adverse events can be mitigated by dose adjustment and/or temporarily pausing other pharmacotherapies for the limited duration of time that HCQ is needed to prevent or treat early Covid-19 post-exposure. Separately from that, other FDA admonishments regarding safety described in its report appear to instead describe those related to long-term dosing not needed for Covid-19 early- or pre-exposure indications or temporary and widely touted “stop the spread” initiatives.
Hydroxychloroquine Is Objectively Safe When Used Appropriately:
Following the unauthorized pandemic surge of HCQ use, a clearer message from America’s FDA to the American public about the safe uses of HCQ should have taken place but didn’t. Instead, the FDA kept silent, did not specifically warn consumers about circumventing America’s medical and pharmacy system, and let Americans make (sometimes fatal) HCQ-related usage errors. The FDA then released a surveillance memorandum essentially pronouncing HCQ as “unsafe” for Covid-19. The FDA made that safety declaration despite the CDC promoting the use of HCQ back in 2019 as safe and “a relatively well tolerated medicine.”
In fact, HCQ is considered so safe for non-Covid-19 indications that the CDC states that “HCQ can be prescribed to adults and children of all ages. It can also be safely taken by pregnant women and nursing mothers.” The CDC was referencing the long-term use of HCQ for chronic disease treatments.
If the CDC considers it safe for long-term treatment, it is only logical to assume that it would certainly be safe for short-term use against quickly spreading viral infections like Covid-19.
Hundreds of other studies (listed in the bibliography of this paper) have been shown to only rarely report safety concerns during limited duration of HCQ administered for Covid-19. Of those, almost all were minor, and of those, all appeared to resolve upon drug discontinuation. The specific reports of HCQ safety are detailed in the summaries following each citation in the bibliography.
FDA Duplicity: FAERS Is OK to Vilify Hydroxychloroquine Safety, but NOT OK to Denigrate mRNA Injection Safety:
The FDA’s heavy reliance on AERS reports in denigrating HCQ in its report was not only biased – it was ironic.
In the past, the FDA and the NIH have repeatedly scolded the use of FAERS as having “not been verified” and “not establish[ing] causation” and that “correlation is not causation” as an excuse to seemingly selectively ignore correlation, and how FAERS “Rates of occurrence cannot be established with [FAERS] reports” and how FAERS findings have “no definitive proof of the causal relationship between exposure to the product and the reported event.”
Therefore, by the FDA’s own account, any of the supposedly valid 256 HCQ FAERS cases cited in its reports could have been:
1) Exaggerated,
2) Not allowed to be used to calculate or imply an incidence rate, (which the press did anyway),
3) Attributable to causes other than HCQ and
4) *If* used to calculate rate, the potential calculated incidence rate of 291 cases worldwide would represent an exceptionally small relative adverse event incidence, but we don’t know that because the FDA did not provide or estimate the 291 cases versus the total number of patients dosed. In other words, the 291 figure is the numerator, but what is the denominator?
The FDA based its safety decision on a worldwide solicitation of a total of 331 reports from all sources (a huge fraction of which were obvious clinically inappropriate uses and/or overdoses and/or in people over the age of 60), over an approximate five-month period, including 256 worldwide reports in FAERS, including: 25 total reports in the entirety of published medical literature, 20 reports form the NPDS, and 11 “other” reports of nebulous origin. One-hundred and nine total HCQ/chloroquine were adjudicated as “serious cardiac related” and an additional 113 were “serious non-cardiac.”
No indication was given that non-fatal adverse events didn’t fully resolve following short-term HCQ use discontinuation or the full course of treatment to prevent or treat Covid-19.
As is clear, the adverse events that occurred had mitigating factors. HCQ is considered to be a safe drug with relatively few adverse event reports. In fact, a comprehensive search for the total number of adverse event reports for HCQ/chloroquine over the past 55 years of worldwide use (including very minor adverse events and those adverse events originating from known drug-drug interactions) in the FDA AERS database showed a grand total of 32,011 cases according to the most recent database update in 2024. The clinical use of chemical precursors of HCQ date back nearly 100 years, but safety and adverse event collection databases only date back to around 1969.
Relative Safety of Hydroxychloroquine’s 32,011 vs >1,000,000 mRNA FDA Reports:
While 32,011 adverse event reports is not inconsequential, compare that to the over 1 million adverse event reports submitted to the FDA’s Vaccine Adverse Event Reporting System (VAERS) for mRNA Covid-19 shots, total, just since 2021 (i.e. ~3.5 years) – and not in the whole world – but in the United States alone, with tens of thousands of those million known to be serious, permanent, and/or deadly.
In fact, the number of worldwide deaths reported from mRNA injections (over 37,500) during its three years on the market exceeds the total number of reported adverse events that occurred during the entire 55-year history of HCQ use. Of note, an abundance of HCQ adverse events associated with the short-term use of HCQ were minor, and included things like nausea, decreased appetite, and fatigue, which are adverse events associated with many different drugs.
Despite that, around the same time that the deluge of mRNA adverse events were reported, America’s self-proclaimed “expert fact-checkers” repeatedly used their megaphones to scold Americans that HCQ was “unsafe.” Major medical research centers and fact-checkers told Americans that numerous mRNA adverse event reports and unexplained sudden deaths and clinical reports of cancers were “not causation” and on top of that, Covid mRNA shots are additionally “Proven Safe” and “Not Dangerous” and “Do NOT Need To Be Withdrawn From The Market” [capitalization theirs].
One does not need to be an expert in drug safety epidemiology to distinguish the incongruity between the continued EUA followed by full approval for novel mRNA Covid injections with hundreds of thousands of adverse events, compared to rapid HCQ EUA withdrawal following 331 worldwide HCQ adverse event reports, an abundance of seemingly related to improper sourcing/use/dosing/supervision.
Major Journal Articles Declaring Hydroxychloroquine as Unsafe for Covid-19:
Prior to HCQ’s EUA removal, a seemingly highly coordinated and unquestionably harmonized message came out against HCQ from American’s press, making it appear that Trump’s HCQ recommendation was not only “unsafe” but that it also “didn’t work” for Covid-19. Harvard, Stanford, and Scripps Institute scientists (respectively) warned Americans via a Washington Post article that Trump’s efforts to employ HCQ were “desperate” and “If there was ever hope for [HCQ], this is the death of it” and “It’s one thing not to have benefit, but [HCQ] shows distinct harm.”
The scientists quoted above were referencing Lancet and New England Journal of Medicine articles that were widely referenced as a means to criticize Trump’s proposal for implementation of HCQ for Covid-19. Both publications were later retracted by journal editors due to being fraudulent.
They were retracted by the journals when its authors “refused to give [auditors] access to all the data they asked for” following publication when results were questioned by outside scientists who questioned why HCQ, with such a historical safety record suddenly appeared so unsafe for Covid-19 patients. Questions led to an investigation which eventually revealed that none of the publication’s authors norjournal “peer-reviewers” had likely ever seen the 96,032 patient data in the first place, because it never existed. The critical question is: why did those so-called “peer-reviewers” permit publication of highly incongruent safety findings for HCQ before thoroughly confirming those findings?
Following the redaction, Lancet’s editor, Richard Horton, stated he was appalledwith the authors, calling the HCQ-lambasting study “a shocking example of research misconduct in the middle of a global health emergency.” Lancet’s editor did “…apologise to the editors and to readers of the Lancet for the difficulties that this has caused.”
The same press that had no reservations about hysterically labeling the Trump administration as wrong for attempting to advance HCQ and coordinating messaging against him was almost completely silent and of course did not coordinate or harmonize any correction admitting that they had not verified highly questionable data even though people’s lives were at stake.
It is known today that the press and medical journals were not just wrong but outrageously wrong, about both their declaration and the methodology they employed to arrive at their conclusions despite supposedly delivering “real truth,” being “fact-checked” and delivering “real facts,” and/or claiming to be “peer-reviewed research.”
Consequences for Publishing False Hydroxychloroquine Data?
The now retracted articles had been primarily authored by Mandeep Mehra MD, a Harvard Medical School professor who also serves as the director of the Brigham and Women’s Hospital Heart and Vascular Center. On a side note, Dr. Mehra retains both positions/titles to this very day, in what has become an all too familiar patternof Harvard and other prominent university officials maintaining their prestigious and lucrative positions despite publication fraud and/or incompetence.
The second author on both papers was Sapan Desai MD, who had claimed to have the world’s largest and most sophisticated patient databases, under his now defunct Illinois-based company, Surgisphere. As it turns out, his database which had reported harmful effects tied to HCQ among patients with Covid-19 never existed, and the “peer-reviewers” at the supposedly “top tier” Lancet, and New England Journal of Medicine whose job it was to critically review the data never actually verified any of the highly questionable epidemiology findings contrasting HCQ’s legendary safety record in autoimmune disorders and malaria, as detailed in an abundance of publications plus FDA’s AERS database.
The third author of the paper, Professor Frank Ruschitzka MD, (like Harvard’s Mehra) still holds his Chairmanship of the University Heart Center and the Department of Cardiology at the University Hospital in Zürich, Switzerland.
The fourth author on the paper, Amit Patel MD is related to Sapan Desai through marriage. He is the only author who has been directly “punished” for publishing fraudulent data, having “mutually agreed” to having had his unpaid, adjunct faculty position at the University of Utah, terminated.
Further investigations into Sapan Desai by others found multiple, egregious incidences of medical fraud along with multiple incidence of clinical malpracticeand negligence preceding his Lancet publication — something that journal peer reviews should have been tuned in to and considered while reviewing his data for publication.
Although Dr. Desai was allowed to voluntarily surrender his medical licenses in Ohio and Illinois, it appeared to be related to patient care-related matters. An internet search did not show any pending litigation against Dr. Desai for fraudulently publishing medical data. It is unclear if Dr. Desai or any other authors are facing criminal charges for falsifying negative clinical findings about HCQ.
It is unknown what if any ramifications occurred to either journals’ “peer-reviewers” as a result of allowing these fraudulent safety-incongruent HCQ data to be published.
Blind Regurgitation of Faulty Journal Publications by the Lay Press:
Politicians and “trusted journalists” with zero education or training in science – let alone no background in pharmacology – let alone no background in the intricacies of investigational medicine, epidemiology, or the clinical assessment of drug safety – exuberantly leapt to criticize Trump’s HCQ proposal, based on both unverified or fraudulently written journal publications.
Here are just some of the many quotes:
The New York Times stated that Trump’s HCQ efforts were “Likely for nothing” and gushed about how “Medical experts across the country… applauded the FDA’s withdrawal of the [emergency use] waiver” in referring to HCQ.
Another Washington Post article stated that HCQ use for Covid-19 “makes no sense” and “no medical evidence supports Trump’s hydroxychloroquine obsession” in a piece titled: “…People who take his [Trump’s] advice may die” in referring to HCQ.
ABC News stated that Trump’s recommended use of HCQ for Covid-19 “directly contradicted guidance from the nation’s top public health agencies and officials.”
The medical and pharmacology heavyweights at Salon.com opined that HCQ was “Revealed to be useless for treating COVID-19” stating that Trump’s “[HCQ] stockpile epitomizes presidential incompetence.”
Arizona Democratic Representative Raul Grijalva adjudicated HCQ as “useless” stating that Trump used “lies and falsehoods” promoting HCQ, seething that “Trump creates a crisis everywhere he goes and consistently puts his own desire to be right above the health needs of everyday Americans.”
The reliably gormless Arizona Republic journalist E.J. Montini, who for years, can barely write an article not denigrating Trump, also opined on drug safety, calling Trump’s followers “hydroxychloroquine kooks” adding his smarmy epithet for Trump’s medical experts (ostensibly including Yours Truly) as a “coterie or bootlicking minions” [SIC]. Montini trusted regurgitated propaganda from other lay reporters regarding the Lancet and the New England Journal of Medicine as nothing short of biblical wisdom, beyond any deliberation, discussion, or critical analysis.
Former independent presidential candidate Robert F Kennedy, Jr (RFK) was also called out for his promotion of HCQ. RFK was chastised as recently as a few days ago, on August 23, 2024 by “fact-checkers” at the putatively venerable University of Pennsylvania in a piece titled: “RFK Jr.’s COVID-19 Deceptions” which stated “As we’ve written, clinical trials of both ivermectin and hydroxychloroquine have shown no evidence of effectiveness against COVID-19”…despite the analysis of hundreds of HCQ studies involving hundreds of thousands of patients detailing the exact opposite and with high statistical probability. How peculiar that not even one scientist or physician from University of Pennsylvania’s Perelman School of Medicine (which incidentally has dedicated epidemiology and biostatistics faculty) were seemingly consulted, referenced, or quoted anywhere within its “fact-check” declarations, especially since the authors do not appear to have formal statistical/ epidemiological/medical/pharmacology/pharmacy training themselves.
Timeline of the Distortion Hydroxychloroquine Safety, Almost Immediately Following Trump’s Proposal:
In case anyone has forgotten about the actual, carefully worded declarations that President Trump made, delicately suggesting that data had shown that HCQ could be useful for Covid-19, here are his actual statements made during his press conference:
Trump directly stated during a press conference on March 20, 2020 that he proposed to use HCQ for early treatment “at the beginning” of Covid-19 infections at 0:22 in the video above. Trump was right to suggest that because today, there is a great deal of evidence that early (or even prophylactic) treatment with HCQ is very effective for Covid-19.
During the same March 2020 press conference and standing alongside Trump, Fauci very accurately stated that “[HCQ] toxicities are rare, and in many respects, reversible” at 1:50.
Following Trump’s proposal and subsequent stockpile of product, HCQ experienced a stunning, seemingly coordinated, fall from favor.
First, Fauci changed his mind regarding his March 2020 statement following the publication in the New England of Medicine on May 1, 2020 (later retracted), the FDA’s problematic methodologies in its review on May 19, 2020 (discussed above), and the Lancet’s publication on May 22nd, 2020 (later retracted).
Despite historical evidence of HCQ being both safe and effective, physicians, politicians, and organizations, taking their lead from incorrect narratives from Fauci, the press, and medical publications, rushed to parrot outrageously incorrect anti-HCQ on top of highly emotional anti-Trump narratives.
Summary:
“Tip-tier” medical journals, mainstream press, hospitals, administrators, insurance companies, Big Pharma, state/municipal government, on top of every federal alphabet agency and others all converged to a singularity of promoting a grand illusion of manufactured consent that demonized HCQ while favoring novel, minimally tested, minimally effective, expensive commercial Covid-19 treatments. The linked meta-analysis now proves HCQ’s effectiveness. It’s no exaggeration to state that the manipulation of data that occurred with HCQ (and other repurposed drug treatments) was the biggest scandal in the history of American medicine, and one of the biggest medical crimes against humanity.
The mission of science and scientists is to cultivate critical thinking coupled with a willingness of its disciples to adjust their thinking and admit being wrong about existing ideas or theories. In other words, recognizing that no science is ever entirely “settled” and therefore should not be silenced.
Confirmation bias in referencing select HCQ RCTs was not science.
The FDA’s safety memorandum on HCQ involved inappropriate, cherry-picked data and was not science.
Ignoring the standard of care and mostly considering late and very late and inappropriate doses/durations of HCQ treatments as a means to denigrate Trump’s HCQ proposal was not science.
Silencing medical and scientific experts critical of the White House, FDA, and Big Pharma was not science.
The lay press’s incompetent evaluation and parroting of highly flawed HCQ data was not science.
Articles from The Hill, Forbes’s, and Politico which rushed to amplify critique on HCQ and Trump – but following study retraction, keep their articles online and continually accessed by the public, was not science.
Medical journals not demanding lay-press corrections on updated/retracted findings based on its internal “peer-review” failures to verify non-sequiturHCQ findings was not science.
Hospital narratives regarding HCQ published on public-facing websites was not science.
The failure of “peer reviews” at “top-tier” medical journals to consider established clinical treatment standards of early treatment was not science.
Allowing non-medically trained “fact-checkers” to comment on medically and technically complex aspects of pharmacology and medicine was not science.
Punishing community pharmacists and physicians for appropriately choosing to dispense and prescribe HCQ for Covid-19 was not science.
Demanding a single “consensus” on how pharmacists and physicians were permitted to treat Covid-19 was not science.
A federal official (or any one person) referring to himself uniquely as “the science” was not science.
Thousands of well-educated scientists and clinicians in America’s federal government, universities, and hospital settings ignored the historical, careful scientific evaluation process established over millennia by their scientific predecessors. No falsehood regarding HCQ for Covid-19 was too great, and every distortion of the truth was justified as necessary, not only to destroy HCQ, but Donald Trump’s mere well-intended recommendation of using HCQ for eligible patients.
This is how the anti-HCQ narrative was created. Everyone in charge seemed to mysteriously unify themselves in a coordinated “consensus” against HCQ.
In place of HCQ, new, minimally tested, expensive, extremely complex, rarely used gene therapy technology was proposed by Big Pharma, then unscientifically mandated by the Biden White House, and funded with obscene debt. The lies about HCQ and other repurposed treatments like ivermectin were promoted by the government and news organizations, making it seem like mRNA injections, unlimited boosters and novel, FDA-sanctioned therapies were only acceptable ways to prevent or treat Covid-19. The end product of the falsehoods and mRNA mandates adversely affected every single American citizen, with a very select few reaping astonishing profits, borne on the back of taxpayers.
Donald Trump and RFK’s recent collaboration and collaboration to Make America Healthy Again (MAHA) should eventually include a full investigation into blockaded HCQ as a repurposed treatment for Covid-19 in order to better understand its seemingly coordinated and wholly inappropriate condemnation.
It is no exaggeration to state that had Trump been allowed to proceed with his endeavor to distribute HCQ for Covid-19 in an appropriate patient population, we would be living in a much different United States of America. Today’s cumulative safety and efficacy findings on HCQ data are unequivocal proof detailing its benefits, particularly for the early treatment of Covid-19.
DISCLAIMER: Do NOT discontinue or initiate taking ANY drug without first discussing it with a pharmacist or physician you know and trust.