On November 19, 2020, four physicians testified before the Senate Homeland Security and Governmental Affairs Committee chaired by Senator Ron Johnson (R.,WI).

Testifying were Peter McCullough, MD, vice chair of Internal Medicine at Baylor University Medical Center and a professor of medicine at Texas A&M College of Medicine; Dr. George Fareed, MD, a Family Medicine Specialist who graduated from Harvard Medical School where he was a professor and also at the UCLA School of Medicine; Harvey A. Risch, MD, PhD., is Professor of Epidemiology, Yale School of Public Health; Ashish K. Jha, MD, MPH Professor of Health Services, Policy, and Practice Dean of the School of Public Health Brown University.

Dr. McCullough opened his remarks by saying that with this new surge in cases, hospitals are not yet at capacity but could be eventually overwhelmed (as flu season is just getting underway) if there isn’t early at-home intervention. He urged government officials to be more helpful in assisting primary care physicians with early COVID-19 treatments. Dr. McCullough stated unequivocally that “we prevent hospitalization and death.”

He is upset with the current “official” National Institutes of Health guidelines and recommendations. Dr. McCullough said he can’t think of a single viral infection where the official medical protocol is to wait two weeks or more before any treatment is started — in a hospital. Not before. Not at home.

Dr. McCullough is also an unapologetic proponent of the early use of hydroxychloroquine (HCQ). So are Dr. Fareed and Dr. Risch. Dr. Jha is not supportive of HCQ and was severely criticized for his position.

Dr. McCullough said there are “four pillars” to medically responding to a pandemic: “Contagion Control; Early Home Treatment; Late Stage Treatment; and Vaccination.” His particular focus was on stage two, “Early Home Treatment” which he says we have “tragically ignored.”

“Patients wait in fear at home after testing positive, logically thinking they would face a terrifying hospitalization, isolation, and at worse — death.” He said physicians actually dealing with COVID-19 patients have had to be “innovative and courageous” use “clinical judgment and learn from all sources of evidence to come up with a treatment plan for at-home patients” since “regulatory barriers have blocked access to generic drugs in at-home treatment protocols.”

He emphasized that “doctors are being forced to create endless workarounds to get medicine quickly before the virus spirals out of control in their vulnerable patients.”

Dr. McCullough told the committee that not only has the government been unsupportive of physicians trying to keep terrified virus infected patients out of hospitals but “government agencies and medical organizations have admonished doctors for responding to COVID-19 patients outside of the hospital and have actively discouraged attempts to treat patients.”

This does considerable harm to frightened high-risk patients few of whom have much of a chance to avoid being hospitalized.

Dr. McCullough was harsh with his criticism: “Astonishingly, the National Institutes of Health, in its October 9, 2020, COVID-19 Treatment Guidelines directs doctors to let even high-risk COVID-19 patients sicken at home for two weeks or more and when finally gasping and choking for air, place them in hospital isolation.” He added, “The NIH (National Institutes of Health) says that a COVID-19 patient may receive their first medical treatment only if oxygen is given.” This is astonishing.

“(NIH) Treatment Guidelines directs doctors to let even high-risk COVID-19 patients sicken at home for two weeks or more and when finally gasping and choking for air, place them in hospital isolation.”

Many bureaucrats and some academicians believe that no medical care is the best care for at-home treatment which Dr. McCullough says is “medically irresponsible and humanely unconscionable.” (Unlike many academics and physicians who have never even treated a COVID patient) “I have managed COVID-19 over the spectrum of illness, and I can tell you that I would never allow a high-risk COVID-19 patient to go without treatment, become progressively panicked and unable to breathe, and force them to the hospital possibly never to see their loved ones again.”

He urged “in-power” bureaucrats to approve oral drugs that are safe and have been shown to be highly effective in reducing the effects of the virus. This means hydroxychloroquine. Dr. McCullough told the committee that they (hydroxychloroquine when given with azithromycin and zinc) are “not a cure, but allow the patient to get through the illness without taxing the health care system by requiring hospitalization.

*     *     *

Dr. George Fareed testified that he has “30 Years of clinical experience, treating HIV and other infectious diseases as well as practicing primary care medicine. I have experience treating COVID patients both in the flu stage as outpatients, but also as hospitalized inpatients.”

He agreed with Dr. McCullough that one of the key goals in dealing with this pandemic is to treat COVID patients as early as possible before they get very sick.

There are two clinics in California where he works which have had about 2,400 COVID-19 patients. He said he has successfully treated hundreds of high-risk patients who were symptomatic.

Dr. Fareed was specific in his treatment protocol. “We have always used a triple hydroxychloroquine (HCQ) cocktail: HCQ (3200 mg over 5 days), azithromycin or doxycycline (500 milligrams per day for 5 days or 100 milligrams twice a day for 5 to 7 days of doxycycline) and especially zinc, which is often left out in studies but is very important. The cocktail is best given early within the first 5 to 7 days … when the virus is in the period of maximal replication in the upper respiratory tract.” They also found this drug cocktail to be effective during the early onset of influenza.

He explained the goal is two-fold: (1) to give the patient the best chance for a full recovery and (2) to prevent hospitalization (and burden the system).

“I use it especially in high risk individuals (over 60 or with comorbidities and anyone with moderate to severe flu symptoms) — the healthy do not need the treatment.”

Dr. Fareed said he has experienced wonderful results. “I have seen very few hospitalizations, and only a few deaths in patients that were sick to begin with and received the medication late while hospitalized. I have not seen a single negative cardiac event and few other side effects, despite what we hear in the media.”

The California physician was forceful in telling the committee that his testimony was not about politics but “only about the science — the science of viral replication, the science of the stages of COVID and the science why early treatment works.”

Dr. Fareed closed by emphasizing that “This is not about an opinion of an expert; this is about science and data.”

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Dr. Harvey Risch told Senator Johnson’s committee that viral replication is an outpatient condition and should always be treated as such. This disease progresses in phases from replication to pneumonia to a multi-organ attack. Once pneumonia sets in, the disease becomes life threatening and hospitalization is required.

Dr. Risch said he was “astounded that studies of (inpatient) hospital treatments were being represented as applying to outpatients, in violation of what I learned in medical school about how to treat patients.”

“…government research institutions have invested billions of dollars in expensive patent medication and vaccine development but almost nothing in early outpatient treatment, the first line of response to managing the pandemic.”

He said it was irresponsible to apply such studies that dealt exclusively with inpatient treatments to outpatient protocols or in an outpatient setting.

He added, “our government research institutions have invested billions of dollars in expensive patent medication and vaccine development but almost nothing in early outpatient treatment, the first line of response to managing the pandemic.”

This is treatment that must be started within the first five days of the onset of symptoms especially for older adults with “chronic conditions such as diabetes, obesity, heart diseases, lung diseases, kidney diseases, immune-system diseases, survivors of cancer etc.”

Dr. Risch says he has examined every study of medication given for early treatment with high-risk patients. He said, “What I have observed is that while there have been positive reports about a number of drugs, every study of outpatient use of one drug, hydroxychloroquine, with or without accompanying agents, has shown substantial benefit in reducing risks of hospitalization and mortality.”

As an academic himself, he explained to the committee that there are two major types of studies. One is “double-blinded, randomized controlled trials (RCTs), and the second is non-randomized (nRCTs) but still controlled trials.”

Most of the government bureaucrats and academics have publicly stated that RCTs not only provide the strongest evidence of effectiveness, but many claim “they provide the only trustworthy form of evidence.”

This is not so according to Dr. Risch. He said, “the great majority of drugs used to treat heart diseases were established with non-randomized trials.” Even the most commonly prescribed antibiotic for children, azithromycin, was not found to be effective through RCTs.

A British organization that performed a “meta-analysis of meta-analyses” that looked at randomized versus non-randomized trials and found they arrived at virtually identical conclusions.”

Hydroxychloroquine is extremely safe. Its been used for 65 years by “hundreds of millions of people in tens of billions of doses worldwide.” Its been routinely prescribed “to older adults, children, pregnant women and nursing mothers.”

This means discounting nRCTs is scientifically inaccurate. “This is the real evidence about why good non-randomized trials comprise evidence every bit as important as randomized trials,” says Dr. Risch.

He applied this knowledge to the drug, hydroxychloroquine. What is the first factor he studied? Is the drug safe. Many FDA approved drugs have minimal or no positive impact but what is mandatory is whether or not the medication is safe.

Dr. Risch said hydroxychloroquine is extremely safe. Its been used for 65 years by “hundreds of millions of people in tens of billions of doses worldwide.” Its been routinely prescribed “to older adults, children, pregnant women and nursing mothers.”

He said University of Oxford investigators “examined cardiac arrhythmias and found no increase for hydroxychloroquine users. This was in more than 900,000 hydroxychloroquine users.”

There are approximately seven studies that examined the use of hydroxychloroquine with high-risk outpatients. “[A]ll showed about 50 percent or greater reductions in hospitalization or death” without any fatal cardiac arrhythmia according to Dr. Risch.

Like Drs. McCullough and Fareed, Dr. Risch also took the FDA to task. He said it erroneously put out a warning letter on July 1 about hydroxychloroquine for use by outpatients by extrapolating studies from its use in sicker hospitalized patients. He said that enormous sums have been spent and efforts made toward vaccines and inpatient treatments but nothing but false warnings against inexpensive, early outpatient regimens while “a quarter of a million Americans have died from this mismanaged approach.”

“…enormous sums have been spent … toward vaccines and inpatient treatments but nothing but false warnings against inexpensive, early outpatient regimens while “a quarter of a million Americans have died from this mismanaged approach.”

As an epidemiologist he offered that even if vaccines are discovered to be effective, there will still be many uncertainties about there efficacy to older adults, high-risk patients or even how long the immunity they provide may last.

Dr. Risch said there is no scientific or economic reason why hydroxychloroquine should not be approved and used immediately. “The evidence for benefit of hydroxychloroquine used early in high-risk outpatients is extremely strong, and the evidence against harm is also equally strong,” he testified.

He advised that the EUA (Emergency Use Authorization) states that when the preponderance of the evidence demonstrates that drug is safe, it should be granted approval.¹

The Yale professor concluded his statement by informing the committee that the risk/benefit evidence for hydroxychloroquine is stronger than for temporarily FDA approved drugs like remdesivir and the “difficult to use bamlanivimab.” …This egregious double standard for hydroxychloroquine needs to be overturned immediately and its emergency use authorization application approved.”

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Dr. Ashish Jha spent much of his opening statement explaining the drawbacks and potential dangers of hydroxychloroquine. But virtually every study he mentioned dealt with very sick patients in hospital settings, not with outpatients early in illness.

“We must protect the health and safety of patients by relying on science. Only by following established standards of evidence can we ensure that experimental treatments are not harmful to patients, said Dr. Jha.

“The death toll of this pandemic is unprecedented, and it comes as no surprise that many of us physicians, patients, and policymakers are desperate for solutions, and are tempted to resort to desperate measures. But it is precisely during a pandemic that we need science most and when the risk of sacrificing that scientific rigor is greatest,” Dr. Jha added.

The advocacy (of HCQ) by the other physicians was criticized by Dr. Jha, “Widespread, unregulated use of hydroxychloroquine significantly delayed our ability to assess its efficacy in clinical trials.”

Chairman Johnson asked Dr.Jha, “Have you treated any COVID patients, Dr. Jha?

He responded, “No I have not, sir.”

This was an astonishing insult to the other physicians testifying; that they were foolishly sacrificing “scientific rigor” and even delaying life-saving results from clinical trials.

But he didn’t stop there.

“Short-circuiting the scientific process risks a number of serious harms to patients, in both inpatient and outpatient settings,” lectured Dr. Jha.

He concluded by stating, “At present, we simply don’t have enough evidence to answer many of these questions for hydroxychloroquine…”

Chairman Johnson asked Dr.Jha, “Have you treated any COVID patients, Dr. Jha? He responded, “No I have not, sir.”

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Dr.McCullough was furious at Dr. Jha’s testimony. He said, “Senator, I want my testimony to clearly be on the record that I think Dr. Ashish Jha’s testimony is reckless and dangerous for the nation.”

“I want my testimony to clearly be on the record that I think Dr. Ashish Jha’s testimony is reckless and dangerous for the nation.”

He strongly added that Dr. Jha’s position shows that blame goes beyond just the government’s inaction regarding hydroxychloroquine.

Dr. Risch also responded to Dr. Jha’s testimony. He said that all studies of hospitalized patients are irrelevant to these discussions as they are focusing on at-home therapies and outpatient treatment that should begin within the first five days.

“We have a million doctors and have a million nurse practitioners on the sidelines right now. They are saying we don’t know what to do. The government is telling us to do nothing… I do not hear a sense of urgency at all. We are weeks away from panic and massive mortality…”

Dr. McCullough warned, “This is a massive calamity that is right around the corner. …We have a million doctors and have a million nurse practitioners on the sidelines right now. They are saying we don’t know what to do. The government is telling us to do nothing… I do not hear a sense of urgency at all. We are weeks away from panic and massive mortality…”

Dr. McCullough interjected that there is a tremendous amount of academic and medical “malfeasance” to go along with the government’s culpability. He said the publication of these bogus studies was nothing short of academic fraud. One study was published and withdrawn just two weeks later but after the results had already been disseminated by the media and the reputational damage done. He said, “the New England Journal of Medicine and Lancet acknowledged that they are fraudulent papers. They were to scare people on hydroxychloroquine.”

Dr. McCullough fumed, “I’m a cardiologist. I reviewed a paper that made its way into the academic literature demonstrating that it causes a heart attack; it causes a giant scar on the heart and I can tell you we have the world’s most recognized cardiology program in the world. … I can tell you firsthand it doesn’t cause giant scars on the heart.

“With now a over a quarter million Americans and nearly 1.5 million worldwide dead of COVID-19, academic medicine is committing fraud and a crime against humanity.”

He chastised his fellow academics, “With now a over a quarter million Americans and nearly 1.5 million worldwide dead of COVID-19, [by using scare tactics against hydroxychloroquine] academic medicine is committing fraud and a crime against humanity.”

He provided his personal experience with COVID-19.

“I’m 57. I’ve got asthma. I’ve got orthostatic cardiovascular disease. [When I tested positive] I was terrified as is every American [who gets it.] Every older patient with heart and lung disease when they get the report … are scared to death. By the time they come to the hospital it is sheer terror because they know they will be isolated and may never see their family members again.”

“A massive calamity is right around the corner. I’m asking and pleading for the Senate [to take action and intervene so we don’t] absolutely get clobbered with a tsunami of mortality particularly for the elder citizens.”

Dr. McCullough continued: “I got into a clinical trial and took hydroxychloroquine as part of a multi-drug program which is exactly what the peer-reviewed literature [says]. … The virus got into my lungs. I had pulmonary involvement, and I got anxious. I can tell you firsthand this cocktail of drugs works for sure. Hydroxychloroquine dose by dose settles down the fever and reduces the severity and intensity of symptoms. That is the reason why hydroxychloroquine reduces hospitalizations and deaths among patients…”

In places like India where hydroxychloroquine is given to patients immediately when they show symptoms, its “death rate is a fraction of America’s” (about one-eighth).

Dr. McCullough pleaded with the committee, “A massive calamity is right around the corner. I’m asking and pleading for the Senate [to take action and intervene so we don’t] absolutely get clobbered with a tsunami of mortality particularly for the elder citizens.”

“We have a million doctors and have a million nurse practitioners on the sidelines right now. They are saying we don’t know what to do. The government is telling us to do nothing… I do not hear a sense of urgency at all. We are weeks away from panic and massive mortality, according to Dr. McCullough.

Dr. McCullough strongly reiterated that the biggest gap in dealing with COVID-19 is early treatment. There is that two week opportunity to attack this deadly virus before it gets traction yet there has been woeful silence by the government when it comes to at-home oral therapies.

The core of the problem is “the NIH and the biopharmaceuticals right now have delivered zero oral medications to doctors in practice. Zero. That’s our batting average right now. So for all the science we’ve put into this as a country with the greatest pharmaceutical companies in the world, zero oral drugs for the next patient who gets sick with COVID-19.”

As Chairman Johnson interjected this thought: “[I]t’s baffled me (the anti-HCQ sentiment in DC) and I will point out again may be part of the reason is the hydroxychloroquine cocktail is about $20. Remdesivir costs over $3,000. Could that be one of the reasons why the effort is put on these more exotic therapeutics that cost thousands of dollars versus something off-the-shelf that costs $20? Something to consider.”

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APPENDIX:

International Journal of Antimicrobial Agents
26 October 2020, 106214
STUDY:  “COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study”

This study published (online) on October 26, 2020 is purported to be one of the first retrospective case studies of its kind: to assess whether outpatients, in a primary care situation, getting a hydroxychloroquine (HCQ) “cocktail” shortly after the onset of symptoms had better outcomes than those that did not. This was a triple therapy of zinc, low-dose, HCQ and azithromycin. It is the same drug cocktail that has been pilloried by academicians and bureaucrats alike since President Trump expressed encouragement about the effectiveness of HCQ last spring.

 

Highlights:
• First COVID-19 outpatient study based on risk stratification and early antiviral treatment at the beginning of the disease.
• Low-dose hydroxychloroquine combined with zinc and azithromycin was an effective therapeutic approach against COVID-19.
• Significantly reduced hospitalization rates in the treatment group.
• Reduced mortality rates in the treatment group.

 

All data for the study was collected from treated patients this year (2020).
There were 141 patients in the treatment group (TG) and 337 in the group that was not treated (NTG). All of the TG received HCQ, 136 also took zinc sulfate and 133 got all three.
In the TG, 4 of the 141 (2.8%) total patients were eventually hospitalized. This was markedly fewer than in the NTG which saw 58 of its 377 (15.4%) patients end up in the hospital. According to the study, “the odds of hospitalization of treated patients was 84% less than in the untreated patients.”
In the TG, all four who were hospitalized were experiencing shortness of breath. One patient stayed one day, two patients were discharged as cured (more than one day) and one patient (0.7%) died though “This patient had a history of cancer and only took one daily dose of the triple therapy before hospital admission.” None of the TG ended up on a ventilator.
In the NTG, 13 of the 377 (3.4%) expired from COVID-19.
In the TG, there were “no reported cases of palpitations or any cardiac side effects.”
The authors say the value of the study is multifold. They say, “Starting triple therapy as early as possible after symptom onset is critical for treatment success … [as] the viral load appears to peak at Days 5–6 after symptom onset and severe cases progress to ARDS (Acute Respiratory Distress Syndrome) after only 8–9 days. …[T]his underscores the role of early intervention by primary care physicians as reported herein.”

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1- FDA Press Announcement:

In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate COVID-19. And, when used to treat COVID-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the authorized population.