(Part 1 of 2)
The Senate Homeland Security and Governmental Affairs Committee held its second recent hearing on the current progress with early out-patient treatment for the COVID-19 virus.
Six highly respected physicians from various specialties testified that they are frustrated with the snail’s pace of Washington’s COVID oversight bureaucracy’s response to rapidly changing information. They are also fed up with what appears to be a lack of urgency while Americans continue to die, needlessly in many cases.
In attendance at the Senate hearing were Drs. Armand Balboni, M.D., Ph.D., CEO of Appili Therapeutics, Jay Bhattacharya, M.D., Ph.D. Professor of Medicine at Stanford University, Pierre Kory, M.D., Pulmonologist and Professor of Medicine at St. Luke’s Aurora Medical Center, Jane Orient, M.D., Executive Director of the Association of American Physicians and Surgeons, Ramin Oskoui, M.D., Cardiologist and CEO of Foxhall Cardiology and Jean-Jacques Rajter, M.D., Pulmonologist at Broward Health Medical Center.
There was absolutely stunning testimony about how little has changed for at-home or early out-patient treatment. The overarching theme was that now with over 300,000 Americans dead from COVID-19 there is still a decided lack of urgency with the federal healthcare bureaucracies. The traditionally, slow, methodical, double-blind studies are clearly thorough and wholly embraced by Dr. Fauci et.al. But when innovative therapies that have shown great successes on the front lines of the battle with this great enemy, are arrogantly dismissed by the bureaucracy, it is more than irresponsible, it is unethical.
And these physicians appear to have had enough of it.
The committee’s chairman, Senator Ron Johnson, opened the hearing and then recognized the ranking member, Democrat Sen. Gary Peters (MI) for his opening remarks.
Sen. Peters wasted no time in launching a reputational attack on the physicians preparing to testify and those who appeared a few weeks ago.
Regarding the previous (November 19th) hearing, Sen. Peters said it “was used as a platform to attack science and promote discredited treatments.” He considered today’s hearing a waste of time. “Sadly, it appears that today’s hearing will follow the same path, playing politics with public health, and will not give us the information we need to tackle this crisis.”
Senator Peters attacked the professional credibility of the doctors in appearance before they even testified. “I welcome diverse perspectives, but we have a responsibility to follow science and facts, not conspiracy theories and disinformation. … Sadly, today’s hearing will not provide accurate scientific information, or advance any useful efforts to slow the spread of the Coronavirus pandemic,” according to Peters.
Dr. Pierre Kory, a pulmonary and critical care specialist, expressed outrage at Sen. Peters’ disparaging comments. He said, “I want to register my offense at the ranking member’s opening statement… I am a physician and a man of science. I have done nothing, nothing but commit myself to scientific truth and the care of patients.”
“I want to register my offense at the ranking member’s opening statement… I am a physician and a man of science. I have done nothing, nothing but commit myself to scientific truth and the care of patients.”
Science has been the only guiding factor in tireless efforts to combat this disease he maintained. “We have near 2,000 peer reviewed publications among us, led by professor Paul Marik … we came together early on in the pandemic and all we have sought is to review the world’s literature on every facet of this disease trying to develop effective protocols,” stated Dr. Kory passionately.
Dr. Kory added, “We have done nothing but try to figure out how to identify a repurposed and available drug to treat this illness.”
He said he was astonished that after nearly a year of this deadly disease he was not aware of any study or task force commission by the National Institutes of Health (NIH), the Food and Drug Administration (FDA) or the Centers for Disease Control (CDC) that has been “assigned or compiled to review repurposed drugs in an attempt to treat this disease.”
“Everything has been about novel and/or expensive pharmaceutically engineered drugs, things like remdesivir and antibodies in vaccines,” and nothing about cheap, safe, widely used oral medications according to the pulmonologist.
The core of the problem is this: The NIH, CDC and FDA don’t want to approve the widespread use of any drug, even if it has been used safely for other illnesses for decades, if it hasn’t received the blessing of an expensive-to-conduct randomized clinical trial (RCT).
None are being funded by any pharmaceutical company since the patents have long expired on cheap drugs like HCQ (hydroxychloroquine) and ivermectin. Private groups like Dr. Kory’s which have “some of the most highly published physicians in our specialty in the world” are chomping at the bit to take these studies on — but they have no funding to do so.
Dr. Kory was insistent that the inexpensive, widely available drug, ivermectin, has proven itself to be an amazing drug for the treatment of COVID-19. “There is a drug that is proving to be of miraculous impact, when I say miracle, I do not use that term lightly and I don’t want to be sensationalist. That’s a scientific recommendation based on mountains of data that’s emerged in the last three months,” he asserted.
“It basically obliterates transmission of this virus,” claims Dr. Kory. He said it is not only effective as a treatment, it is tremendous as a prophylactic. “If you take it you will not get sick.”
In responding to Sen. Peters’ earlier criticism, Dr. Kory said that, yes, they are “touting things that are not FDA or NIH recommended.” But the reason is because these organizations move like molasses. “The NIH, their recommendation on ivermectin to not use it outside of controlled trials is from August 27th. We are now in December… ..Mountains of data have emerged from many centers and countries around the world, showing the miraculous effectiveness of ivermectin.”
“It basically obliterates transmission of this virus,” claims Dr. Kory. He said it is not only effective as a treatment, it is tremendous as a prophylactic. “If you take it you will not get sick.”
Dr. Kory related the information contained in a very recent study about the use of ivermectin from Argentina. He said, “They prophylaxed 800 health care workers, not one got sick. In the 400 that didn’t prophylax, 59% or 237 of those 400 got sick.”
The group that Dr. Kory is associated with (Frontline Covid-19 Critical Care Alliance) says that “as a prophylaxis agent, it is immensely effective, you will be protected from getting ill.” He added that for early outpatient treatment, ivermectin will reduce the need for hospitalization as well.
Dr. Kory conveyed that though it is not a cure, “It’s proving to be a wonder drug. it has already won the Nobel prize in medicine in 2015 for impacts on global health in the eradication of parasitic diseases.”
As for the bureaucratic agencies demanding peer-reviewed RCTs before any recommendations, Dr. Kory said, “Please recognize, peer review takes time. It takes months, We do not have months. We have 100,000 patients in the hospital right now dying. …I’m a lung specialist. I’m an ICU specialist. I’ve cared for more dying COVID patients than anyone can imagine. They’re dying because they can’t breathe.”
“By the time they get to me in the ICU, they’re already dying, almost impossible to recover. Early treatment is key. We need to offload the hospitals. …Any further deaths are going to be needless deaths.”
Dr.Kory pleaded with the committee, “By the time they get to me in the ICU, they’re already dying, almost impossible to recover. Early treatment is key. We need to offload the hospitals. …Any further deaths are going to be needless deaths.”
The pulmonologist is asking Dr. Fauci and the NIH to review his organization’s data and step up the urgency as the agency’s last update for any outpatient oral medication was on August 27th. Since then over 120,000 Americans have died of COVID-19.
In his opening remarks, Dr. Ramin Oskoui said, “It is the frontline physicians who … with the help of scientific researchers and billion drug pharmaceutical companies must fight and win the war against [this] disease.” He also said the rules must change regarding the time required for typical trails because, “… We don’t have decades of research to look back on with patients who, if we do nothing, may suffer and die needlessly.”
Dr. Oskoui asked, “Why then, for a disease we have never seen before March, are practicing physicians being condemned, ridiculed or shamed in some cases for doing what practicing physicians have always done, using their professional skills and expertise to make the best practical life-saving use of the existing scientific research.
“Many cures or treatments get discovered, drugs or treatments invented and tested for one disease … are applied in a novel way or for an ailment or disease they have not yet been approved for or tested with,” according to Dr. Oskoui. He went on to say that drugs like hydroxychloroquine (HCQ) have been used safely for decades and are now successfully being given early to at-risk patients to keep them out of hospitals.
Dr. Jean-Jacques Rajter, a pulmonologist in Florida opened his testimony by talking about his experiences with very sick inpatients. He said right now his team is taking care of 35 hospitalized patients. With little guidance on how best to treat these patients from Washington, back in April his team believed that the number of people dying called for extraordinary and creative measures to save lives.
“I could not stand idly by as I’ve seen more people die in these last six months than I’ve seen in my entire medical career combined,” lamented Dr. Rajter. He said, “My team was able to develop and implement a protocol that showed tremendous success in treating covid-19. This laid the foundation for the peer-reviewed study which was published in a major U.S.-based medical journal.”
Dr. Rajter informed the committee that, “The overall mortality in that study decreased from 25% in the conventional care group to 15% in the (off-label use of) ivermectin (a drug used for parasitic infections for 40 years) treatment group. Severe pulmonary disease the mortality decreased from 81% to 39%.” These are extraordinary reductions in mortality using ivermectin that the National Institutes of Health (NIH) should have explored thoroughly by now.
“During the second wave of the pandemic it was common for my team to treat in excess of 40 patients with covid-19 on a daily basis. The success rate of the ivermectin protocol is far superior than early days. They’ve been studied across the world yet no major large scaled double blind randomized study has been published in a peer reviewed journal, said Dr. Rajter.
He said, “Of the hundreds treated, only two were admitted to the hospital, one due to heart failure, the other one due to symptomatic delay of over a week before seeking medical attention. Neither one of them died. neither one of them needed intubation.”
“Of the hundreds treated (with ivermectin), only two were admitted to the hospital, one due to heart failure, the other one due to symptomatic delay of over a week before seeking medical attention. Neither one of them died. Neither one of them needed intubation.”
Dr. Rajter added that ivermectin is widely used worldwide with billions of doses administered. The WHO considers it one of its “essential medications.”
Apart from using ivermectin early to ultimately save lives, early intervention also keeps people out of hospitals freeing up beds for sicker patients. This appears especially important now as traditional flu season often fills up hospital beds on its own.
Dr. Rajter spoke about early treatments: “Early intervention is cost effective as it decreases the overall health care expenditure. Early intervention decreases viral transmission in a home setting, which is currently believed to be a major site of transmission. Early intervention increases survival. Even after vaccination programs are initiated. Ivermectin is effective in early disease, post exposure, it’s an oral medication requiring no monitoring. It’s safe, it’s inexpensive and widely available.
He believes it is not just a medical, but an ethical imperative as well that more physicians begin to use ivermectin. “After personally witnessing the results of ivermectin based protocols I cannot stand by and allow hundreds of thousands of people to go untreated,” asserted Dr. Rajter.
Dr. Armand Balboni opened his remarks with a somewhat surprising political statement, “I never thought I would have to say this, but I am a lifelong Democrat with a subscription to the New York Times, and I have to say I was quite dismayed this morning and almost didn’t participate when I saw the news that I was participating as a fringe member of an anti-vaccine group, that couldn’t be further from the truth.”
He said he desired to testify before the committee (in spite of the fact that there were zero Democrat senators in attendance for his testimony), because he says the protocol for the way we are dealing with COVID is terrible.
Dr. Balboni stated, “We can’t continue to send newly infected patients home, with this potential hope of an IV infusion and say put on a mask and wait for the vaccine.” It is a policy of “watchful waiting.” Not really watching but just waiting until the COVID patient, self-quarantining at home, has trouble breathing then seeks hospitalization — if there are available beds.
He was again political when he cautioned, “This protocol confirms that we have a gap in our treatment landscape.”
Dr. Jane Orient spent most of her testimony on the sorry state of bureaucratic urgency.
Regarding the tremendous numbers of frontline physicians who have had considerable success treating at-risk, non-hospitalized patients with HCQ, azithromycin and zine she said, “On August 18th Senators Ron Johnson, Mike Lee and Ted Cruz asked the FDA to provide any studies and data that informed the FDA’s apparent determination that giving hydroxychloroquine to infected outpatients within seven days from the onset of symptoms will have no clinical effect and may be harmful to the patient.”
Dr. Orient continued, “FDA’s tardy response provided no references pertaining to question. The only logical conclusion is that the FDA’s extremely influential determination that prevented treatment for untold thousands of patients was without foundation. (Dr. Orient’s emphasis)
She told the committee that FDA has correctly stated that after it approves the use of a drug, it does not regulate the way physicians prescribe such medications for off-label use. This is true but the FDA’s language is often used as the reason why “many state agencies have forbidden the prescribing or dispensing of HCQ.”
When HHS Secretary Azar sought the expanded use of HCQ based on a physician’s judgement. But the FDA instead issued an “Emergency Use Authorization” (EUA) but only for quite ill hospitalized patients, the group most knew in advance HCQ was “least likely to benefit.” When the EUA was later withdrawn, the drug was (intentionally?) tainted for even early outpatient use. Dr. Orient said that HHS is still “presumably hoarding more than 50 million doses of HCQ in the Strategic Stockpile.”
Dr. Orient stated that there are now “192 studies (126 peer-reviewed) have been compiled on HCQ, with all showing some benefit when used early, in contrast to the handful of studies on remdesivir or monoclonal antibodies.”
She said there is simply no reason why this drug has not been turned loose to primary care doctors to prescribe as they see fit. She said, “HCQ is safer than most over-the-counter drugs.”
“HCQ is safer than most over-the-counter drugs.” — Dr. Jane Orient
The federal agencies that consider RCTs sacrosanct misguided. Dr. Orient said they are not infallible. Some can be designed to succeed of fail. She said there were two such clinical trials in which researchers used “even used toxic or lethal doses” of HCQ.
According to Dr. Orient, this purely “top-down approach” with HCQ resulted in great risks to both doctors and patients. The risks to patients is obvious as many likely needlessly were hospitalized and/or died. Doctors who even prescribed the drug were faced with “termination, investigated or delicensed.”
Dr. Orient said that RCTs are generally fine for testing but they don’t make discoveries. She said the vaccine for smallpox was discovered by doctors “sharing their observations (anecdotes) at a pub.”
She said patients have called her organization frantically seeking a physician who could get them HCQ. One patient was driven from Tucson to Dallas just to find a doctor who would prescribe the drug. “His severe symptoms were relieved within hours,” related Dr. Orient.
Interestingly, she mentioned that, “Quarantines, masks, and lockdowns are not backed by RCTs” but they are certainly widely demanded.
She concluded her opening remarks by imploring the federal government (as represented by the Senate committee) to take immediate action: “What is needed NOW is effective early treatment for COVID-19. HCQ and other safe, long-used agents could be immediately available if government stopped blocking access and deterring use.”
“What is needed NOW is effective early treatment for COVID-19. HCQ and other safe, long-used agents could be immediately available if government stopped blocking access and deterring use.”
Stanford professor, Dr. Jay Bhattacharya’s testimony focused more on the science, or lack thereof, behind lockdowns.
Dr. Bhattacharya said that considerable public policy damage was done “early in the pandemic, the World Health Organization (WHO) publicized a very misleading 3.4% case fatality rate that panicked the world.” It began what appears to be a government’s love affair with shutting down people’s lives.
What wasn’t known originally was how infectious but non-lethal COVID-19 was. Dr. Bhattacharya said we now know that “the fatality rate for the disease, especially for those under age 70 is rarely lethal. Many infections are not identified as cases because they do not come to the attention of doctors or public health authorities. We know from a series of studies of specific SARS-CoV-2 antibodies in the blood, which provide evidence of prior COVID infection, that this is true.”
Dr. Bhattacharya informed the committee that “For people 70 and over, the infection survival rate is 95%. For people under 70, it is 99.95%.” He said, “the harms of the lockdown are manifold and devastating, including plummeting childhood vaccination rates, worse cardiovascular disease outcomes, less cancer screening, and deteriorating mental health, to name a few.”
He said, “the harms of the lockdown are manifold and devastating, including plummeting childhood vaccination rates, worse cardiovascular disease outcomes, less cancer screening, and deteriorating mental health, to name a few.”
He added, “The social isolation induced by lockdown has led to a sharp rise in opioid and drug-related overdoses, similar to the “deaths of despair” that occurred in the wake of the 2008 Great Recession.”
Regarding the topic of early COVID treatment, he said many physicians won’t prescribe these repurposed drugs without a “gold standard evaluation of its efficacy.” Dr. Bhattacharya says the real question ought to be, “why have there been so few randomized evaluations of these therapies?”
Dr. Bhattacharya reiterated that pharmaceutical companies have zero interest in funding a patent-expired drug evaluation or trying to navigate it through the FDA approval process. He added that researchers are available to conduct trials but given that funding won’t come from any drug company, it must come from the NIH. He said, “In principle, the NIH exists to solve this market failure. It could and should use its resources to help fund randomized evaluations of these drugs for off-label purposes.”
“[The NIH’s] lack of interest in the rapid randomized evaluation of non-patented drugs represents a government failure that has likely led to worse COVID-19 outcomes than we would have had otherwise.” — Dr. Jay Bhattacharya
The NIH has “devoted considerable resources to aid the COVID-19 vaccine randomized trial studies … but its lack of interest in the rapid randomized evaluation of non-patented drugs represents a government failure that has likely led to worse COVID-19 outcomes than we would have had otherwise,” Dr. Bhattacharya lamented.
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