The Senate Homeland Security Committee convened a hearing on 19 November 2020 chaired by Senator Ron Johnson (R-WI) to examine “Early Outpatient Treatment: An Essential Part of a COVID-19 Solution.” This hearing was not televised nationally and was sparsely attended, even by its own committee members.
The meeting provided essential insight into why our country has failed miserably in the medical management of COVID-19, especially with high-risk patients. Rather than embracing early treatment, which is how most illnesses are managed, the medical establishment (academia, federal health agencies) has actively suppressed the evidence for early outpatient treatment of COVID-19 illness. The 2-hour and 30-minute hearing is essential viewing for all Americans given that around 275,000 (as of December 1, 2020) of our citizens have died and many aspects of our society are devastated by lockdowns.
There were three physician-scholars supporting early outpatient treatment of symptomatic COVID-19 illness in high-risk patients: Dr. Peter McCullough of Baylor University Medical Center, Dr. Harvey Risch of Yale University, and Dr. George Fareed, Medical Director at Pioneers Medical Center, Brawley, California. Dr. Ashish Jha of Brown University presented the opposing viewpoint.
The hearing began with Senator Johnson, the majority leader, providing background for the early treatment of symptomatic, high-risk COVID-19 patients. The minority leader for the hearing, Senator Gary Peters (D-MI), did not mention early treatment once in his remarks. Rather, he discussed legislation that would create a COVID-19 “disinformation and misinformation” task force purportedly to control the spread of unfounded information and save American lives. He then said, in a veiled reference to the topic being discussed, “we must also be careful about giving Americans a false sense of security by promoting untested and unproven outpatient remedies.”
Senator Peters and his colleagues did not ask a single question to the three physician-scholars advocating for early outpatient treatment of symptomatic high-risk COVID-19 patients. All their questions were directed to Dr. Jha, “the minority expert,” covering topics like testing capability, vaccination, and whether families should gather for Thanksgiving.
Senator Peters and his colleagues squandered a glaring opportunity to expose alleged “disinformation and misinformation” from the assembled physician-scholars recommending early outpatient treatment. If the physician-scholars are promoting “untested and unproven” treatments, as Senator Peters suggested, this was the opportunity to question them in front of the American people. No questions, no challenges, and no discussion with physicians claiming emphatically that “tens of thousands” of lives could have been saved with early treatment supported by hundreds of randomized and prospective treatment studies.
Dr. Peter McCullough, who treats COVID patients, described his scholarly article published in the American Journal of Medicine (August 2020) titled “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection.”
In his testimony, Dr.McCullough described the “four pillars of pandemic response” including “Contagion Control,” “Early Home Treatment,” “Hospitalization,” and “Vaccination.” He emphasized that our collective medical response and media portrayal has ignored early treatment.
He then described the stages of COVID-19 illness to include viral replication, cytokine storm, and microthrombosis. He discussed how early outpatient treatment is a multi-drug regimen to disrupt viral replication, thereby reducing the risk of progression to high-morbidity cytokine storm and microthrombosis.
Hydroxychloroquine (HCQ), the drug most known to the public, is one of several drugs in Dr. McCullough’s published algorithm to not only disrupt viral replication and packaging but to treat the ravaging effects of cytokine storm and microthrombosis.
Dr. Harvey Risch presented his analysis of the research involving early treatment, focusing on the outpatient use of hydroxychloroquine because it is the most studied drug. Dr. Risch emphasized outpatient treatment of symptomatic high-risk patients within the first 5 to 7 days of illness with the “HCQ cocktail,” consisting of HCQ in combination with zinc and an antibiotic, azithromycin or doxycycline. Dr. Risch has published a paper in the American Journal of Epidemiology analyzing the data https://doi.org/10.1093/aje/kwaa093.
His conclusion, drawn from established powerful and informative statistical methods such as meta-analyses, is that early treatment of symptomatic high-risk COVID-19 patients is both safe and dramatically effective.
Dr. George Fareed, who practices in the epicenter of the COVID-19 pandemic in California, presented his clinical experience with outpatient treatment of hundreds of high-risk COVID-19 patients with the “HCQ cocktail.” He works alongside other physicians who collectively have treated a few thousand patients. Dr. Fareed noted that he and his colleagues have seen dramatic outcomes with minimal side-effects, few hospitalizations, and no deaths with early outpatient treatment. Dr. Fareed, who has a background at the National Institutes of Health as a virologist, noted that his treatment is in accordance with the science and pathophysiology as described by Dr. McCullough. Like Dr. McCullough, Dr. Fareed’s treatment regimen extends well-beyond the use of HCQ in managing devastating sequelae of COVID-19 illness.
Dr. Ashish Jha, the Dean of the School of Public Health at Brown University, rebutted as “the minority expert.” Dr. Jha testified that he has not treated COVID-19 patients. Dr. Jha, moreover, has no peer-reviewed articles on the treatment of COVID-19 illness. To be clear, Dr. Jha was testifying as a purported “expert” in the early treatment of COVID-19 illness, yet he has no experience in treating COVID-19 patients and, unlike Drs. McCullough and Risch, has not produced a single peer-reviewed article on the subject.
Dr. Jha testified that his opinions are derived from his review of the scientific literature, stating that none of the ostensibly “high-quality, randomized control trial studies” concluded that HCQ is effective in treating COVID-19 illness. He stated that observational studies were not of sufficient quality to conclude that HCQ is effective. He pointed out that his opinions are in line with the consensus of experts in academia, and are also in accordance with the opinions of the CDC, NIH, and FDA.
Unlike Dr. McCullough, Dr. Jha never discussed the science of COVID-19 illness. In fact, he did not dispute Dr. McCullough’s description of the different stages of the illness, and the rationale for early treatment. Oseltamivir/Tamiflu, by example, interferes with viral replication, disrupting progression of influenza illness. Accordingly, as Dr. McCullough explains, if treatment can interfere with viral replication early in the course of COVID-19 illness, we can confidently prevent progression to higher-morbidity stages of the disease. Again, Dr. Jha did not challenge Dr. McCullough on the science, pathophysiologic, and pharmacologic basis of early treatment for all three facets of the disease: viral replication, cytokine storm, and thrombosis.
Dr. Jha and other recognized national “experts” such as Dr. Fauci, do not offer any recommendations regarding early outpatient treatment of COVID-19 illness, which was the subject of the meeting. Dr Jha’s intention was to deny the overwhelming evidence supporting early treatment with HCQ and ivermectin (IVM)-based protocols. Indeed, outpatient treatment extends far beyond the use of only HCQ. Dr. Jha did not address other aspects of Dr. McCullough’s outpatient treatment protocol targeting the progression of COVID-19 illness to cytokine storm and microthrombosis.
There is an obvious flaw with Dr. Jha’s argument against HCQ and IVM: none of the randomized, control trials that he cited involved early treatment, within 5 to 7 days, of high-risk patients with the full HCQ or IVM cocktail. A cocktail, not just HCQ and/or IVM, is used by doctors around the world to interfere with viral replication in order to prevent progression to cytokine storm and microthrombosis. Dr. Jha, however, never addressed the science of the virus and well-described aspects of COVID-19 pathophysiology.
Dr. Jha, moreover, did not cite a single study disproving the approach of early treatment of high-risk patients. Dr. Jha’s statement that “all the experts are in agreement” is not remotely sufficient medical science polemics. Clinical conclusions and recommendations are based on rigorous data analysis and not merely consensus opinion.
Dr. McCullough has over 600 peer-reviewed publications, including two dozen on COVID-19 disease. He has chaired many high-risk data safety monitoring boards and knows all the inner workings of large-scale clinical trials. Dr. Risch’s expertise is in analyzing data from the literature, and his renowned scholarship has resulted in over 300 peer-reviewed articles. As Dr. Risch emphasizes, all the studies involving early treatment of high-risk patients with HCQ have shown positive outcomes in reducing hospitalization and death.
In the Recovery study cited by Dr. Jha, patients received HCQ when they were hospitalized with evolving or florid cytokine storm; the majority were on supplemental oxygen. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19 | NEJM
The authors of another widely cited randomized control trial from Brazil on hospitalized patients (Cavalcanti et. al) concluded that if HCQ were given earlier, the results could have been different. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 (nejm.org)
Timing of pharmacological intervention is paramount when the goal is disruption of viral replication; it is all about the science, which Dr. Jha did not address in his testimony.
Dr. Jha cited the Boulware et. al. post-prophylaxis study from the University of Minnesota that was never brought to completion but published in the New England Journal of Medicine, a paper that showcases academic fraud regarding HCQ. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19 | NEJM
The study looked at individuals who were exposed to COVID-19 and compared those receiving HCQ post-exposure with those who did not receive the medication. The study concluded that HCQ was not better than placebo in preventing an infection. The authors, however, did not stratify the results as to when the HCQ was actually given; in fact, the raw data showed that those receiving HCQ earlier after exposure had a statistically significant decrease in infection (see analysis Watanabe, Brazil).
(https://arxiv.org/ftp/arxiv/papers/2007/2007.09477.pdf) These results were conveniently left out of the published study. Again, it is about the science and the critical timing of HCQ administration. The earlier one receives HCQ after an exposure, the better ones chances are to not develop a symptomatic infection. This is precisely what the study revealed and yet the results supporting the conclusion were suspiciously omitted.
Dr. Jha’s testimony that there is “overwhelming evidence” against the early, outpatient use of HCQ is false. He provided no evidence to support his opinion- in fact, no such evidence exists. The studies he cited, on hospitalized patients, do not disprove the early, outpatient use of HCQ, and what he presented is best described (using terminology from Senator Peters) as “misinformation” and “disinformation.”
In sharp contrast to Dr. McCullough’s algorithm that focuses on a multi-drug regimen to address the different manifestations of COVID-19 infection, Dr. Jha ignores the science of the virus, and focuses on only one drug, HCQ. Dr. Jha did not offer a single recommendation for outpatient treatment; none! His testimony was solely to discredit HCQ.
The most disconcerting aspect of Dr. Jha’s testimony is the brazenly false assertion that HCQ is dangerous, even with moderate doses recommended for early outpatient treatment of high-risk patients with symptomatic COVID-19 illness. The VA study to which Dr. Jha referred involved hospitalized, sick patients who received high doses of HCQ. Dr. Jha did not acknowledge that HCQ has been used for 65 years for malaria and nearly as long for rheumatoid diseases, and yet he deems it dangerous when used in moderate doses for short courses (typically 1-2 weeks) for early treatment of high-risk outpatients.
This false characterization by so-called “experts” such as Dr. Jha, who have not treated a COVID-19 patient, has likely discouraged countless high-risk patients from seeking outcome-altering early treatment. Dr. McCullough, a cardiologist, and unlike Jha, is very experienced in drug safety evaluations from clinical trials, stated that Dr. Jha’s testimony is “reckless and dangerous.”
It is alarming that around 275,000 Americans have already died in this pandemic, and that number is currently increasing by 1,500 per day. Drs. McCullough, Risch, and Fareed have dedicated themselves to reducing fatal outcomes by advocating early outpatient treatment for high-risk COVID-19 patients.
As Dr. McCullough stressed, many countries are using early outpatient treatment strategies with take-home treatment packets with HCQ and IVM-based regimens. There are websites, such as C19study http://www.c19study.com/ that lists publications from around the world regarding HCQ and COVID-19 illness, irrespective of the results/conclusions. Another website, HCQtrial http://www.hcqtrial.com/ compares the results in countries that use HCQ with those that do not. Everyone can see the facts for themselves.
The statistics do not lie: America and many European countries have failed in their response to the pandemic. One resource, Worldometer https://www.worldometers.info/coronavirus/ features a particularly illustrative statistic, “deaths/million.”
The United States along with most European countries have some of the most troubling statistics in terms of “deaths/million.” The U.S. along with European Union countries have seen deaths/million significantly higher than many less technologically developed countries that rely on early treatment with HCQ. According to HCQTrial http://www.hcqtrial.com/, countries that use HCQ have 70% less death rates as compared to countries that do not use HCQ. These results align nicely with outcomes obtained by physicians such as Dr. Fareed, who unlike Dr. Jha, actually treat COVID-19 patients.
Senator Peters, as stated in his opening statement, seeks to remove “misinformation” from the COVID-19 discussion. Ironically, “misinformation” is precisely what Dr. Jha is doing when he makes the unsubstantiated claim that HCQ is dangerous when used in moderate doses for early treatment of high-risk outpatients without a single study to support this conclusion.
“Misinformation” is highlighted by Dr. Jha’s suggestion that there is no evidence to support the early use of HCQ when the website C19study shows that 96% of studies on the early use of HCQ show positive results and outcomes http://www.c19study.com/. This is significant evidence! Dr. Jha’s testimony could be first-up for Senator Peters’ COVID-19 disinformation/misinformation legislation.
Dr. Risch concludes that the combined literature of observational and retrospective studies provides overwhelming evidence to support early treatment, and that the benefit of early treatment of high-risk patients far outweighs the risk of medication side-effects.
There is always risk-benefit consideration when deciding to pursue a treatment. Television commercials for pharmaceuticals consume much of the airtime delineating potential side-effects. Selection of pharmacologic/therapeutic interventions is a sacred and revered aspect of the physician-patient relationship. An informed patient should decide on treatment with their doctor. Dr. Jha’s therapeutic nihilism does not give him liberty to promulgate false information about HCQ- based treatment for COVID-19 illness.
The insistence on randomized clinical trials (RCTs) by Drs. Jha and Fauci, when the NIH abandoned RCTs with COVID-19 outpatients, is absurd during a pandemic in which Americans are dying at the rate of 1,500 per day. We are fighting a war and the best interventions in such circumstances come from those who are engaged in the battle; for example, Dr. Fareed and thousands of providers who are on the frontlines.
There was no RCT for penicillin in World War II; waiting for such a study would have cost hundreds of thousands of lives. Some of the greatest advancements in trauma surgery were discovered literally on the battlefield, not by RCTs at prestigious academic institutions.
Senator Peters’ proposed legislation to monitor and regulate COVID-19 misinformation would not apply to Dr. Jha, but rather to physicians with therapeutic recommendations that are counter to the desired narrative of self-proclaimed “experts.” Drs. McCullough and Fareed have each produced magnificent videos discussing the science of and rationale for early treatment of COVID-19 illness. The videos were censored and labeled as “misinformation” by YouTube, Facebook, and Twitter without declaring what content of the presentations was not true. Senator Peters wants to make such censorship national policy; this is Orwellian!
The medical profession is best served when physicians challenge and question one another. Dr. Jha, meanwhile, resorts to CNN and MSNBC commentary with political pundits. Dr Jha should discuss the science of proposed treatment protocols with categorical experts like Dr. McCullough, and with frontline physicians with vast experience treating COVID-19 patients, such as Dr Fareed.
Dr. Jha neither considers the rationale for early treatment of COVID-19 illness nor discloses that many countries, including his native India, successfully manage the pandemic with HCQ, IVM, and favipiravir combined with other drugs. If the naysayer “experts” are interested in saving lives, they would focus on early treatment, which is a hallmark and standard of care for physicians treating any identified disease or condition.
One should wonder why the committee minority could not find a single “expert” to testify under oath that HCQ or IVM-based treatment, when used early in the flu-stage of COVID-19 illness, is ineffective and dangerous. In fact, such a physician-expert does not exist.
If there is truth to what Dr. Jha contends, countless physicians and patients would come forward with testimonial horror stories. CNN and MSNBC would gleefully invite such individuals to share their affirming experiences. Yet, not a single case series in the published literature disputes that HCQ or IVM-based early treatment is safe and effective for high-risk COVID-19 patients.
This serves to reinforce wide-spread use of HCQ and IVM-based early treatment for symptomatic COVID-19 illness in countries with scarce medical resources. The best Senator Peters could do was to bring an “expert” who speaks authoritatively but has never treated a COVID-19 patient, and has the chutzpah on social media and with the mainstream media to castigate physicians, who risk their lives treating COVID-19 patients, for spreading “misinformation” and “not following the science.”
This is a clarion call to “wake-up America!” To have arrived at this point of suffering and death while rejecting evidence-based early, life-saving treatment options is simply bone-chilling.
The aftermath of the hearing is telltale. Dr. Jha appeared on multiple cable network shows and gave interviews to multiple publications with the same sinister narrative; Drs. McCullough, Fareed, and Risch are spreading misinformation. Dr. Jha’s opinion piece in the New York Times is a must read and is thoroughly revealing. In this piece, Dr. Jha never discusses the science of the virus or conclusive evidence of the reduction in disease progression or hospitalizations with early treatment. Dr Jha does not discuss any drug except hydroxychloroquine, ignoring the pathophysiology and pharmacologic principles heralded by Dr. McCullough upon which a safe and effective early treatment multidrug regimen is based.
The most egregious and unconscionable accusation by Dr. Jha, however, is that Drs. McCullough, Fareed, and Risch as well as Senator Johnson are “snake oil salesmen” (New York Times editorial). Opinion | Why Is Congress Still Discussing Hydroxychloroquine? - The New York Times (nytimes.com) Dr. Jha, who has never treated a single COVID-19 patient, is compelled to denigrate physician-scholars who risk their lives and give hope by treating acutely ill COVID-19 patients. As if the $50 drug cocktail is making these physicians money! With around 275,000 Americans dead, one would hope that physicians like Dr. Jha would be supportive of physicians “in the field” offering safe and effective early treatment for COVID-19 illness. Shame on Dr. Jha and Brown University!
Why would Dr. Jha so vehemently oppose a safe, inexpensive, effective, readily available treatment that doctors around the world are using with demonstrable success, and at the same time offer no alternative other than to wait for a vaccine? With evidence-based safety and efficacy, why not allow a symptomatic, high-risk COVID-19 patient to decide with their physician how they want to be treated, as in all areas of medicine?
To find an answer, one needs to “follow the money.” Dr. Jha, as documented in his appointment announcement at Brown University, receives funding from the Bill and Melinda Gates Foundation, which is championing a vaccine. Announcement: School of Public Health Dean | The Office of the Provost | Brown University
Early treatment would be perceived by many Americans as an alternative to a vaccine. Dr. Jha has a clear conflict of interest that he did not disclose in his sworn senate testimony, New York Times op-ed piece and during numerous television appearances.
There is no conflict of interest for physicians such as Drs. Fareed and McCullough who use inexpensive, generic medications and nutraceuticals to save the lives of patients with COVID-19 illness. Dr. Jha does not treat COVID-19 patients but denigrates doctors by accusing them of spreading “misinformation and disinformation” and being “snake oil salesmen.”
In Pravda-like fashion, the mainstream media like the New York Times, CNN, and MSNBC are complicit in advancing Dr Jha’s patently false narrative to the public without a contrasting evidence-based discussion from those who actually treat COVID-19 patients and are following the science.
We urge every American to watch the Senate Homeland Security Committee hearing of 19 November 2020 and draw your own conclusions. Note which physician-scholars are focused on the medicine and the science of COVID-19, and who avoids discussing the science. See who is offering an evidence-based outpatient treatment for symptomatic high-risk COVID-19 patients, and who is not proposing any solution, except to go home and “wait and see.”
See which politicians are for censorship and who is for an open discussion, and which politicians refuse to discuss early treatment for symptomatic COVID-19 patients. We believe that you will have an informed perspective as to why there are around 275,000 dead Americans when other countries with considerably less resources have fared much better.