Anti-Vaccine doctor testifies before the Senate | FULL HEARING

dollars of pandemic response the first pillar is Contagion control and of course we've done that with social distancing and economic shutdowns Mass all those types of things the second pillar is early home treatment the third is late stage hospital treatment and the fourth is vaccination if you want to put up the next slide the second slide displayed the three stages of covet of the disease the first stage is viral replication the second cytokine storm and the third micro thrombosis the goal of this hearing is identical to the goal of our first hearing to discuss early treatment options that attack the disease in the first stage by limiting viral replication doing so would hopefully prevent progression to cytokine storm microform boss micro thrombosis and possibly death this is how Tamiflu Works in limiting the severity of the flu is how we approach every other disease early detection allows for early treatment and better outcomes seems like a pretty Common Sense approach to me yet this is not how we've attacked kovid instead we've impoverished Millions by shutting down economies poured billions of dollars into ventilator production and new drug and vaccine development but spent virtually nothing on research and trials using existing drugs and nutraceuticals in fact there's been a concerted effort to block doctors who actually treat covet patients from compassionately using their off-label prescription rights for early treatment protocols why in his Reflections on progress peaceful coexistence in an intellectual Freedom Russian dissident Andre sakharov wrote quote the second basic thesis is that intellectual freedom is essential to Human Society freedom to obtain and distribute information freedom for open-minded and unfearing debate and freedom from pressure by officialdum and prejudices such a trinity of freedom of thought is the only guarantee against an infection of people by mass myths which in the hands of treacherous Hypocrites and demagogues can be transformed into bloody dictatorship freedom of thought is the only guarantee of the feasibility of a scientific Democratic approach to politics economics and culture and today in today's biased news media and social media within academic journals on college campuses in government agencies and Ivory Towers we are losing the freedom to obtain and distribute information the reaction to our first hearing on early treatment is but one example although not surprising in today's hyper partisan climate it is still shocking in that hearing we heard from Dr McCulloch a cardiologist and vice chair of medicine at Baylor University Medical Center Dr Harvey risch senior professor of epidemiology at Yale University and Dr George Farid trained at Harvard University in the National Institutes of Health combined these doctors have more than 900 scientific research Publications extensive drug development experience more than 80 years clinical practice including treating more than one thousand high-risk coveted patients along with thousands of other lower risk covid patients I was hoping that post-election by asking such eminently qualified doctors to testify about the rationale for and growing effectiveness of early treatment Minds could be opened and lives could be saved unfortunately the Democrat witness Dr Ashish Jah began tweeting his negative Viewpoint of early treatment before the hearing even began and continues his media blitz for days afterward most obnoxiously and it was obnoxious he penned and op-ed that New York Times ran and headline quote the snake oil salesman of the Senate unquote the absurdity of causing Dr ja as a witness or paying any attention to him in the media was demonstrated when I asked him during the hearing have you treated any coveted patients his reply I have not sir Dr McCullough also talked about the circle of empathy in medicine those who actually treat coveted patients are in the center not only have they shown extraordinary courage exposing themselves to the disease they also have the greatest empathy for patients who experience the fear and loneliness of a coveted diagnosis these are the medical practitioners the heroes that experts in the Ivory Towers and media have chosen to ignore and vilify the experts far outside the circle of empathy have developed and supported the current NIH guideline of providing no treatment at all until patients are sick enough to require hospitalizations as we are all aware at that point treatment is often too late so here we are again holding a second hearing to obtain and distribute information on what is known about early treatment of covid what could possibly be controversial about that if some are calling this hearing dangerous and instead of waiting until after the hearing to trash this information and our Witnesses the New York Times and other Publications have already run preemptive attacks implying implying this hearing is anti-vaccine so let me be clear this hearing like the first hearing is focused on early treatment of covid it is not about vaccines end of story in my opinion discouraging and in some cases prohibiting the research and use of drugs that have been safely used for decades has caused tens if not hundreds of thousands of people their lives by the time any vaccine is fully deployed no matter how successful how effective how safe Millions more will become infected with effective early treatment fewer people will get seriously ill and fewer people will die so why not give early treatment a shot what have we got to lose and finally why is there such a comforted concerted effort to silence the voices of courageous health professionals promoting early treatment it makes no sense let me make just a final point at the beginning of this and epidemic when I first heard about the potential of hydroxychloroquine it intrigued me because to me a drug like that has been around for 65 years shown to be safe it's cheap billions of tablets are produced every year we could have ramped our production if if that could be proven to be effective wouldn't that be the dream solution why didn't we pursue that in Ivermectin and family peer reviewer why didn't why didn't we look at these drugs who were already there generic cheap Mass producible again it makes no sense without turned over to Senator Peters thank you Mr chairman uh in our nation continues to battle a worsening public health and economic crisis that has taken the lives of nearly 284 000 Americans over 2200 Americans are dying every day from this deadly virus and thanks to the tireless work of our Public Health agencies the private sector and our scientific and medical communities we've made progress in treating this disease the Food and Drug Administration continues to use scientific standards to authorize Innovative and effective early treatments unfortunately today's discussion will not meet those same standards Mr chairman I certainly share your goal of ensuring patients across the country have access to early and effective treatments for Coronavirus but those statements must be based on evidence and not on politics the American people are looking to Congress for accurate information for leadership and for relief last month this committee held a hearing that was billed as a review of early outpatient treatments for Coronavirus unfortunately that hearing Amplified unverified theories about treatments that are not supported by the scientific community instead of hearing from expert Witnesses about scientific developments in the coronavirus treatments or how we can improve the pandemic response the committee was used as a platform to attack science and promote discredited treatments the minority witness an expert in his field was subjected to personal attacks from other Witnesses and from this dice after testifying he faced an online harassment campaign unlike anything he had ever experienced in any prior Congressional testimony this Behavior damages The credibility of this committee and does nothing to advance the health and the safety of the American people sadly it appears that today's hearing is going to follow the same path playing politics with Public Health and will not give us the information that we need to take on this crisis the minority was not consulted about the scope of this hearing before it was noticed the panelists have been selected for their political not their medical views and for that reason the composition of the panel creates a false and terribly harmful impression of the scientific and medical consensus the witnesses have made many harmful inflammatory statements those statements include undermining a covid-19 vaccine promoting unproven Therapeutics discouraging Common Sense measures to stop the spread of the virus like social distancing and mask and even comparing Physicians who support these interventions to supporters of a Nazi regime now I certainly welcome diverse perspectives but we have a responsibility to follow science and to follow facts not conspiracy theories and not disinformation to that end I'd like to enter Mr chairman into the record this statement from 50 Public Health experts about the importance of Science in our pandemic response I'd also like to enter into the record an op-ed written by Dr jaw the minority witness prior uh in the prior hearing regarding his experience before this committee and finally I'd like to enter statements from four public health and scientific organizations that discuss scientific integrity and the needs of our communities during this pandemic without objection that could be entered into the record Mr chairman without objection Mr chairman Senate hearings like Medical Treatments should be based on evidence this hearing like the hearing before it and the hearing before that is unfortunately not I very much regret that in this time of need Americans cannot turn to this committee for some sound guidance Mr chairman we can still turn the tide of this pandemic we can work together to ensure that scientists have the resources that they need to conduct research and federal agencies have the resources they need to support and evaluate to these efforts we should be working to ensure that doctors nurses and First Responders have personal protective equipment that they need to care for patients in a safe manner we should be passing bipartisan legislation that provides desperately needed Financial relief to families States and small businesses and in the coming weeks we expect that the first coronavirus vaccines will become available we should be conducting strong oversight including hearing testimony from government officials responsible for vaccine development and distribution the Commerce Committee will be holding a subcommittee on how we'll ensure every American can get a vaccine later this week we'll be discussing that and I look forward to participating in a robust discussion with both scientific and Logistics experts we owe it to the American people to get this right and sadly today's hearing will not provide accurate scientific information or Advance any useful efforts to slow the spread of the coronavirus pandemic thank you Mr chairman well thank you Senator Peters I hope anybody who listen to that opening statement anybody who's read the the Articles prior to this uh hearing we'll actually go back and take a look at the video that we edited of our previous hearing that I hope they actually listened to the witnesses and to their testimony into the questions and answers and just really understand how far from reality the ranking members opening statement truly was now it is the tradition this committee is swearing Witnesses so those of you on WebEx if you'll just raise your right hand two witnesses here if you'll stand and raise your right hand do you swear that testimony you would give before this committee would be the truth the whole truth and nothing but your truth so help you God our first witness is Dr Ramin Oscar so I at best I get him 50 right Dr osui is a native Washingtonian he's a graduate of Georgetown University College of Arts and Sciences and Columbia University College of Physicians and surgeons he trained at Georgetown University Hospital in Internal Medicine and cardiovascular disease at Washington Hospital Center he is board certified internal medicine and cardiovascular diseases he is CEO of fox fox hall Cardiology in Washington DC he's a past president the medical staff at Sibley Memorial Hospital and was physician of the Year for 2015 for Sibley Memorial Hospital Johns Hopkins since 1996 his peers have continuously voted him as one of washingtonians magazine's top doctors in cardiology he's treated several dozen covid-19 patients patients and is published in the area and since I announced your presence of this hearing I've heard from all kinds of patients what a fabulous doctor you are you're very kind thank you for coming here thanks for being a doctor Dr Oscar it's my honor I'm going to just read from my brief personal statement I've been make sure make sure your microphones on and that the microphone is close to your your mouse so we can hear the red light on it but it looks like it's green okay my name is Dr raminoski I'm a board certified cardiologist and internist who practice who is licensed to practice in DC Maryland in Virginia and as the senator correctly stated I've treated several dozen uh code patients since the outbreak of the pandemic my remarks are directed in part to the differing roles and responsibilities of scientific researchers and government agencies and practicing physicians in the healthcare crisis whenever there's a Health crisis whether it's a worldwide pandemic or a family member hit with stroke or heart attack or nations practicing positions not only the critical First Responders in many cases they are the only ones on the line working with and for the patient there are brilliant practitioners of academic medicine and MB phds many of them employed by our most profitable drug companies who develop seemingly miraculous cures or therapies but it is the front line Physicians who certainly with the help of scientific researchers and billion dollar drug pharmaceutical companies must fight and win the war against disease particularly a disease or ailment that is new and we don't have Decades of research to look back on with patients who if we do nothing may suffer and die needlessly why then with the disease we had never seen before in late March our practicing positions being condemned ridiculed or shamed in some cases for doing what practices have always done using their professional skills and expertise to make the best practical life-saving use of the existing scientific research it would be wonderful if last March the FDA or the NIH or a few big drug companies could have announced an instant cure for a disease that had just been discovered or of course in that event we would have all prescribed it easy peasy but they didn't have it then and they don't have it now that's one reason why the FDA encourages the use of FDA approved drugs approved for one disease to be responsibly and ethically used in the field for other ailments not yet researched or approved in fact that is how many cures or treatments get discovered drugs or treatments invented and tested for one disease or ailment are applied in a novel way or for an ailment or disease they have not yet been approved for or tested with the health policy establishments criticism of the front line doctors was over the top and it was unfounded first for example drugs like hydroxychloroquine Ivermectin which are FDA approved for certain uses have extensive safeguards even for non-approved uses they were both An approved decades ago and have an established record of efficacy and a comprehensive information on possible side effects that Physicians can review and are legally and ethically required to review before prescribing secondly the fact is that no doctor should be prescribing these drugs or in fact any drug without following standard protocols observed for any drug or any patient even if there is FDA approved scientific research proving that hydroxychloroquine works for malaria its approved use or lupus along alternate use one must do a case history and consider the individual patient before prescribing it practicing medicine may be an art as much of a science but is certainly not quote paint by the number earlier this year we faced a new dangerously infectious virus in such a Health crisis like any other crisis with an unknown and unproven enemy cannot rely exclusively on the tried and true but it was worse than that affirmative steps to keep Physicians and patients ignorant were taken indeed censorship of scientific research indeed medical McCarthyism became the norm it is not an insult against science to conclude that actions should be taken in the midst of an emergency based on the best facts available nor any more than it is an insult against history to use tactics or strategy in our National Defense that have not been peer reviewed I believe that Landing crafts were rarely used in full-scale amphibious Invasion before D-Day the ones we developed specifically for that purpose obviously could not be tested in full Battlefield conditions does that mean we could not go ahead with the Normandy invasion because we had no double blind peer-reviewed studies for these vehicles I think weather forecasts that day was a bit sketchy too even outside of an emergency it is no disrespect to science to say some Medical Treatments that some Physicians deem prudent for their patients should be allowed and yes promoted even if those have not been the subject of someone's peer-view PhD thesis or years of regulatory process very few of us will become drug company Executives top medical researchers or high-ranking health bureaucrats but it is almost guaranteed that each of us is quite likely sometime somewhere to be a patient under the care of a trusted Position will hopefully have the help not the hindrance of the research establishment thank you thank you Dr osqui our next witness is via WebEx Dr Jean-Jacques reiter Dr Ryder is a Broward Health Medical Center physician who specializes in pulmonary medicine internal medicine and critical care he previously served as the chief medical information officer for Broward Health and as an assistant professor at Drexel University College of Medicine Dr Ryder serves as a speaker for glaxel Smith Klein AstraZeneca and Forest Laboratories as well as service on advisory boards for Pfizer his Publications most recently include a study titled quote use of ivermectin is associated with lower mortality and hospitalized patients with coronavirus disease 2019. unquote Dr Ryder received his MD from The Drexel University College of Medicine and has accumulated over 22 years of experience in this field Dr Ryder thank you very much honorable chairman and senators of the committee on homeland security my name is Dr zajak Ryder I'm unfortunately unable to attend these hearings in person as I'm currently taking care of over 35 hospitalized patients and it's an honor and privilege to stand here in front of the committee providing first-hand experience on the early treatment for covet 19. my team has gained extensive experience with the treatment of covid-19 in both inpatients and of patients during this pandemic back in April we were faced with a rapidly deteriorating patient population with no effective treatment extraordinary time call for Extraordinary Measures I could not stand idly by as I've seen more people die in these last six months that I've seen in my entire medical career combined based on individual data by Dr Wagstaff my team was able to develop and Implement an ivermectin-based protocol that showed tremendous success in treating covet 19. this laid the foundation for the peer-reviewed icon study which was published in chest in major U.S based medical journal the overall mortality in that study decreased from 25 percent in the conventional Care Group to 15 percent in the Ivermectin treatment group in patients with severe pulmonary disease at onset the mortality decreased from 81 percent to 39 percent 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 this icon protocol has been optimized since and we have learned a lot from our successes and failures the success rate of the ivermectin-based protocol is now far superior to what it was in its early days I remaking these protocols have now been studied across the world yet no major large-scale double-blind randomized controlled study has less been published in a peer-reviewed journal I will defer more review of the literature to Dr Corey who is going to be testifying later recent in vitro studies confirmed our clinical experience that the dosing regimen of iramectin 200 micrograms per kilogram on two consecutive days was clinically effective of the hundreds of outpatient treated by my team only two I repeat 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 both of them have now been discharged to home without complications Ivermectin is a widely used medication with excess of 3.7 billion doses administered worldwide it is currently part of the World Health Organization model list of essential medications the icon dosing regimen is based on currently accepted dosing regimen for Norwegian scabies the dozing regimen has long-standing safety data safety of a medication is due to its pharmacokinetics and possible interactions but not on its intended use as is the case with any infection early intervention has been proven time over again that is of critical importance the same is due for it's the same is true for covet 19. early intervention increases the likelihood of keeping people out of the hospital and hence decreasing the pressure on the Health Care system early intervention is cost effective as it decreases the overall health care expenditure early intervention decreases viral shedding and vile transmission into home setting which is currently believed to be a major site of transmission early intervention increases survival early intervention decreases the economic impact notwithstanding impending vaccination programs vaccines are not 100 effective and may not be widely available for many months many patients may be unable to take the vaccines for healthcare reasons or opt not to do so long-term immunity of these vaccines has not yet been documented based on these factors treatment for covid-19 will need to remain on the Forefront even after vaccination programs are initiated however mechan is effective in early disease latest post exposure prophylaxis and pre-exposure prophylaxis Ivermectin is an oral medication requiring no monitoring either mechanism safe Ivermectin is inexpensive and widely available the U.S has spent billions of dollars on a multitude of treatment options my team is ready to proceed with the randomized controlled trials to address any residual doubt relating to Ivermectin use yet we're unable to do so due to lack of funding and support a few hundred thousand dollars may definitely prove or disprove the effectiveness of ivermectin for early treatment with a properly designed and implemented randomized control trial funding a little bit more funding could look at the effectiveness of pre and post exposure prophylaxis using avermectin a couple million dollars could complete a multi-centered double-blind inpatient placebo-controlled try forevermectin ladies and gentlemen I implore you as a Frontline provider of covid-19 to do better to provide us the answers we need as Healthcare Providers to help your constituents survive this horrible pandemic in great numbers after personally witnessing the results of ivermectin-based protocols I cannot stand by and allow hundreds of thousands of people to go untreated thank you thank you Dr Ryder our next witness is here in person Dr Pierre Corey Dr Corey is the former associate professor in Chief of the critical care service and medical director of the trauma and life support center at the University of Wisconsin and recently joined the ICU service at Aurora St Luke Medical Center in Milwaukee he is board certified in critical medicine pulmonary diseases and Internal Medicine Dr Corey has traveled across multiple states in the U.S to care for covid-19 patients throughout the pandemic he's also the president of the Frontline covid-19 Critical Care Alliance a non-profit organization of Critical Care Specialists led by Professor Paul Merrick whose mission over the last nine months has focused on the research and development of effective treatment protocols for covid-19 using repurposed drugs he received his MD from St George's University School of Medicine and I'll only add that we added Dr Corey very late to our I think a hearing in May because I had heard of his development of I guess anti-inflammatory steroids in critical care on covid and Dr core I have to tell you I've had doctors come up to me and thank me for holding that hearing where they listen to you change their thinking they believe they've saved their patients lives because of your testimony a bad hearing I I hope your testimony will be as impactful today Dr Corey Senator thank you and and thank you for uh holding this hearing I just want to start out I didn't think I'd have to say this but I want to register my offense at the ranking members opening statement I was discredited as a politician 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 and and to hear that I'm here because of a political angle I am not a politician I'm a physician I want to start out by saying that I'm not speaking as an individual I'm speaking on behalf of the organization that I'm a part of we are a group of some of the most highly published physicians in the world we have near 2 000 peer-reviewed Publications Among Us led by Dr Professor Paul Merrick who's our intellectual leader 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 you just mentioned that I was here in May and I touted I wouldn't say I recommended that it was critical that we use corticosteroids in this disease when all of the national and international Healthcare organizations said we cannot use those that turned out to be a life-saving recommendation I am here again today with a new recommendation in the last nine months in our review of all of the literature as a group again we are some of the most highly published physicians in our specialty and the world we have done nothing but try to figure out how to identify a repurposed and available drug to treat this illness we have now come to the conclusion after nine months and I have to point out I am severely troubled by the fact that the NIH the FDA and the CDC I do not know of any task force that was 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 postalizumab and rendezvir and monoclonal antibodies and vaccines we have hundred years of medicine development we know we are expert in all the medicines we use and I do not know of a task force that has been focused on repurposed drugs I will tell you that my group and our organization I will say that we have filled that void we that is all we have done is focus on the things we know and things we do and I'm here to tell you Dr writer he just presented it was one he has one study of the many that I want to talk about and I want to talk about that we have a solution to this crisis there is a drug that is proving to be of miraculous impact and when I say miracle I do not use that term lightly and I don't want to be sensationalized when I say that that is a scientific recommendation based on mountains of data that has emerged in the last three months when I am told and I just had to hear this in the opening sentence that we are touting things that are not FDA or NIH recommended let me be clear the NIH their recommendation on Ivermectin which is to not use it outside of controlled trials is from August 27th we are now in December this is three to four months later mountains of data have emerged from all from many centers and countries around the world showing the miraculous effectiveness of ivermectin it basically obliterates transmission of this virus if you take it you will not get sick I want to Briefly summarize the data my manuscript again published by some of the the the most con we have contributed more to the medical knowledge of our specialty in our careers than anyone else can claim as a group and our manuscript which was posted on medicine pre-print server details all of this evidence I want to Briefly summarize it number one we have evidence that Ivermectin is effective not only in prophylaxis in the prevention if you take it you will not get sick we just came across a trial last night from Argentina by the lead investigator of I've invented in Argentina Dr Hector carvallo they prophylaxed 800 health care workers not one got sick in the 400 that they didn't prophylaxis thyromectin 58 that's like 237 of those 400 got sick if you take it you will not get sick it has immense and potent antiviral activity we know that from the first study of Monash it has made the bench to the bedside prophylaxis we now have four large randomized controlled trials totaling over 1500 patients each trial showing that as a prophylaxis agent it is immensely effective you will not get sick you will be protected from getting ill if you take it in early outpatient treatment we have three randomized controlled trials and multiple observation as well as case series showing that if you take Ivermectin the need for hospitalization and death will decrease the most profound evidence we have is in the hospitalized patients we have four randomized controlled trials there multiple observation trials all showing the same thing you will not die or you will die much much much lower rates statistically significant large magnitude results if you take Ivermectin it is proving to be a wonder drug it is already won the Nobel Prize in medicine in 2015 for its impacts on global Health in the eradication of parasitic diseases it is proving to be an immensely powerful antiviral and anti-inflammatory agent it is critical for its use in this disease we again stand by our manuscript it is a scientific management it's been submitted for peer review but please recognize peer review takes time it takes months we do not have months we have a hundred thousand patients in the hospital right now dying I'm a lung specialist I'm an ISU specialist I've cared for more dying coveted patients than anyone can imagine they're dying because they can't breathe they can't breathe they're on High level oxygen delivery devices they're on non-invasive ventilators and or they're sedated and paralyzed and attached to Mechanical ventilators that breathe for them and I watch them every day they die by the time they get media in the ICU they're already dying they're almost impossible to recover early treatment is key we need to offload the hospitals we are tired I can't keep doing this if you look at my manuscript and if I have to go back to work next week any further deaths are going to be needless deaths and I cannot be traumatized by that I cannot keep caring for patients when I know that they could have been saved with earlier treatment and that drug that will treat them and prevent the hospitalization is Ivermectin this is I am here today I'm calling to action the NIH their last recommendation was August 27th August 27th I want to be clear I am not here as a politician or a dramatist or sensationalizing what I'm recommending I'm going to be very clear and very simple all I ask is for the NIH to review our data that we've compiled of all of the emerging data we have almost 30 studies everyone is reliably and reproducibly positive showing the dramatic impacts of ivermectin please I'm just asking that they review our manuscript it is a serious manuscript by serious highly experienced Physicians and researchers we we have I cannot call on more credibility than we have we're not just a random Doctor Who's saying that we have a cure I don't want to say I have a cure I'm just asking review our data we have immense amounts of data to show that ivermected must be implemented and implemented now Senator the last thing I want to say is you know who's dying here it's it's our African-American and Latino and elderly it's some of the most disadvantaged and impoverished members of our society they are dying at higher rates than anyone else it's the most it's it's the most severe discrepancy I've seen in my medical career and we are responsible to protect those disadvantaged members we have a special duty to provide countermeasures the amount of evidence to show that Ivermectin is life-saving and protective is so immense and the drug is so safe my colleagues have talked about it it must be instituted implemented I'm asking the NIH to review our data and come up with recommendations for society thank you okay well thank Dr Corey and I will I will make you this guarantee that uh before the day is out we'll have a letter first of all we'll enter all your data into our hearing record and then I'll have a letter to the NIH asking them to review it please and hopefully I'll have some Sanders join me in that our next witness is Dr Armand Balboni Dr Balboni is the chief executive officer for Apple Lily Therapeutics his career has included medical research and Drug development experience in civilian academic and Military organizations he's a partner and a member of the board of directors of Bloom Burton and Company where he is the firm senior advisor for regulatory medical Affairs as an active duty military officer Dr Balboni served as a staff officer in the U.S army Research Institute of infectious infectious diseases he completed a military staff fellowship at the U.S Food and Drug Administration and wanted to serve as the deputy director of clinical and Regulatory Affairs for the U.S army Dr Balboni has held multiple academic positions at Westfield State University the University of Maryland University College and the United States Military Academy at West Point Dr Balboni completed his doctoral work in the MD PhD program at the icon school of medicine at Mount Sinai and earned his law degree at Brooklyn law school Dr Balboni so thank you Mr chairman uh uh ranking member of Peters and the entire committee for for your leadership and the opportunity to speak today about the need for early treatment Dr Melville if you could talk a little bit louder before you boost his sure is that any better it is thanks all right great so yeah again thank you for this opportunity to uh to speak as as you've noted um I've worked in the Infectious Disease front lines in many roles I'm a simple drug development uh physician and scientist um and I say that uh with all with all humility um as a military fellow at the FDA during the Ebola crisis we looked at some of these drugs uh broad spectrum antivirals to include things like Faba pure reviewer and remdessavir we are no further along now than we were then with getting those drugs approved because of the very fragmented nature of what we do um as our approach to treating these kinds of illnesses um I have to say uh uh I never thought I would have to say this um but I am a lifelong Democrat with a subscription to the New York Times and I have to say it was quite dismayed this morning it almost didn't participate when I saw the news that I was participating as a fringe member of an anti-vaxxer group that is that couldn't be further from the truth um I read further down in the in New York Times and saw that 202 000 new cases were presented uh yesterday in the U.S and I'm and I'm confronted with the with the motto that accompanied meal in over 17 years as a physician and scientist in the U.S army one team won fight and Mission first um we've got to get this right I remain deeply concerned with our long-term viability to combat not only kobit 19 but other pandemics that inevitably will happen um we have to take a whole a government approach um the last 11 months have shown us what we can do when we do that it's redefined what's possible for vaccine development we may be on the precipice of new technologies that that will absolutely inform how we develop vaccines in the future but we are not done um many are ready to say that we did it with vaccines and some effective treatments that that have been noted to be quite expensive and useful in limited situations um but we're failing to adequately build a Continuum of solutions data-driven solutions for copit19 um and the inevitable future pandemics we need options now at every stage and in scalable and readily implementable ways as the crisis worsens we need oral broad spectrum uh Therapeutics to be able to treat patients in the outpatient setting we can't treat them adequately and we can't continue to send newly infected patients home um with this uh potential hope of an IV infusion um and and say put on a mask and wait for the vaccine uh we we can't live with the the outcomes there I might I tip my hat to my colleagues at infusion clinics and and uh those setting up uh clinics in tents and parking lots but the drugs are too expensive not available and unlikely to help the the hundreds of thousands of of patients that are that are coming out of this the vast majority of Americans just to be clear that who test positive we tell them to self quarantine employee watchful waiting and then go to the hospital if they have beds if their system if their symptoms worsen this protocol confirms that we have a gap in our treatment landscape we need an oral Stars cov2 specific treatment right now that that helps to treat those with confirmed infections and one that's practicable scalable and can bring a plug and play uh type of approach to our Health Care system as as this committee addressed and and my colleagues that are witnesses here have also addressed we have to include vaccines and best medical practices nobody who's denying that nobody here is an anti-vaxxer um and I again I have to say take great offense to that to that statement as a scientist and physician um oral antivirals um targeting SARS Club E2 offer a strong solution um we we have the potential to to play an important role in the hands of positions treating their covid-19 patients outside of the hospital again these drugs are not intended to replace covid-19 vaccines and many promising oral antivirals are most effective when used early most will never have access most patients will never have access to them as we attempt to bring all the risk out of our large randomized control trials to fully weed out we as a as a group are running two large phase three trials in the U.S under IND in a phase two post-exposure prophylaxis trial and long-term care we are doing that work and I do not suggest that we abandon our gold standard rcts however to singularly rely on rcts in the middle of a pandemic is just not common sense we need to develop a hybrid trial methodologies by combining the best parts of rcts and observational studies to produce real world data right now that can together with our rcts present Real World evidence about how these things can be used it's our best chance to save lives now and during future outbreaks if we fail to change our approach we're going to be talking about this the next time there's an outbreak it's going to happen it's unfortunate but we've got to utilize um this pandemic to bring solutions to these patients right now thank you Mr chairman thank you committee for your consideration thank you Dr Balboni our next witness is Dr Jane Orient Dr Orion has served as the executive director of The Association of American Physicians and surgeons aaps since 1989 and is currently president of doctors for disaster preparedness more than 200 of her papers and op-ed pieces have been published in the scientific and popular literature on a variety of subjects including risk assessment natural and technological hazards and non-hazards and medical economics and ethics she's the editor of aaps news the doctors for disaster preparedness newsletter civil defense perspectives and is the managing editor of the Journal of American Physicians and surgeons Dr Orient obtained her undergraduate degrees in chemistry in mathematics from the University of Arizona in Tucson and her MD from Columbia University College of Physicians and surgeons in 1974. Dr Orient is formerly clinically is formerly clinical faculty in the department of internal medicine at the University of Arizona College of Medicine has been in Solo Private Practice of General Internal Medicine since 19 1981 Dr Orient thank you chairman Johnson and ranking member member Peters and committee members for allowing me to present the plea of practicing Physicians for early and prophylactic home treatment for covid-19 and also thanks to the witnesses for the opportunity to learn from you we urge the committee to exercise your oversight functions over federal agencies that are effectively blocking treatment that could prevent a hundred thousand needless deaths and stop the crippling fear and the destruction of millions of livelihoods on August 18th Ron John Senator Ron Johnson Senator Mike Lee and Senator Ted Cruz asked the FDA to provide any studies and data that informed the fda's apparent determination that giving hydroxychloroquine uh to infected outpatients within seven days from the onset of symptoms will have no clinical effect and may be harmful to the patient fda's tardy response provided no references pertaining to the question the only logical conclusion is that the fda's extremely influential determination that prevented treatment for Untold thousands of patients was without Foundation FDA commissioner Stephen Hines stated correctly that FDA has no authority to regulate the practice of medicine and the doctors have the right to prescribe approved drugs for off-label uses but as aaps is shown in its lawsuit against the FDA State agencies have used the fda's language as the basis of regulations to block or forbid the prescribing or dispensing of hydroxychloroquine in March HHS secretary Azar asked Barda for a nationwide expanded access investment investigational new drug protocol for hydroxychloroquine and chloroquine in the National strategic stockpile but ins this would have legitimized these drugs for the treatment of kova 19 outside a hospital but instead influential Physicians are officials non-physicians transformed the request into an emergency use authorization only for hospitalized patients to the patients who were the least likely to benefit so instead of expanding excess the eua restricted access and later FDA withdrew the eua further impeding its use and the Asus is presumably still hoarding more than 50 million doses of hydroxychloroquine while people are complaining about a potential shortage and it's November meaning the AMA refused to rescind its unprecedented statement calling for possessions to stop prescribing hydroxychloroquine until sufficient evidence becomes available to conclusively illustrate that benefit outweighs harm yet there have been 192 studies compiled on hydroxychloroquine with all showing some benefit when used early in contrast to the handful of studies on remdessevir or monoclonal antibodies which are the only things that the NIH recommends more than 65 years of experience in hundreds of millions of patients have demonstrated safety hydroxychloroquine is safer than most over-the-counter drugs including acetaminophen however organized medicine and academic Physicians such as Dr Ashish jaw have stated that the evidence is insufficiently scientific doesn't meet their gold standards of the randomized controlled trial but the fact is that most of the guidelines that we use for most diseases have relied on Lower orders of evidence necessarily and studies with appropriately analyzed data give results identical to rcts and rcts themselves are not infallible because they can be designed to succeed or designed to fail researchers in two hydroxychloroquine trials even use toxic or lethal doses of the drug and then notice that yeah it didn't harm Publications in the most prestigious journals does not assure reliability there were huge studies that were based on probably fabricated data with flies that were undetected by the peer reviewers or the editors a Russian publication and had to be retracted by Lancet and the New England Journal of Medicine but not quickly enough to prevent their significant misleading and harmful effects rcts are useful for testing but they're not for making discoveries which are often serendipitous like the use of iron mentioned for example in patients nursing home patients with scabies the smallpox vaccine was discovered because GPS were sharing observations now we call them anecdotes at the pub they noticed that farmers who had had cowpox didn't seem to get smallpox or they may result from the study of basic science and observation on patients like today's protocol for Wegner granulomatosis was based on a 1973 article of non-randomized patients which was written none by none other than Dr Anthony fauci today we have top-down authority-based standard of care for early covid promulgated by hnih guidelines it which is therapeutic nihilism we've lately added the expensive largely unavailable monoclonal antibodies but other than that before the patients in the hospital and on oxygen the NIH recommends nothing this is shocking and unprecedented but in today's litigious environment doctors who follow this standard of care are protected and those who dare prescribe outside of it could be fired removed from their insurance panels investigated and even de-licensed a patient's Nationwide are calling off us at aaps searching for a doctor who will treat them one patient told me he had had his wife drive him all the way to Dallas when all the doctors he knew in Tucson refused to prescribe for him and his symptoms got better within hours of getting hydroxychloroquine from the doctor in Dallas doctors are reporting to us that they can't get hydroxychloroquine for their nursing home patients and the family doctors that have the doctors even told us that infectious disease specialists have refused to treat coven patients we're relying on quarantine's masks and lockdowns these are not backed by rcts they have not stopped the pandemic they're not sustainable vaccines are touted as the great hope but we don't have them yet and they have not yet been shown to prevent contagion what we need now is effective early treatment for coven 19. hydroxychloroquine and other safe long used agents such as Ivermectin is showing particular promise but there are others they could be immediately available if the government stopped blocking access and deterring their use Physicians need to do as they've always done they need to respond to the needs of their patients use the best available information share that information and continuously strive to do better thank you so much for this opportunity thank you Dr Orion our Final witness is Dr Jay bhattacharya Dr bharachary is Professor of medicine at Stanford University and a research associate at the National Bureau of Economics research Dr bhattacharya's research focuses on the health and well-being of vulnerable populations with the particular emphasis on the role of role of government programs biomedical Innovation and economics Dr bhattacharya's Recent research focuses on the epidemiology of covid-19 as well as an evaluation of policy responses to the epidemic Dr Bob's Chariot was the senior author of the first studies of the Cerro prevalence of covid-19 Los Angeles County and Santa Clara County as well as the Major League Baseball cereal prevalence study excuse the co-author of the Great Barrington declaration which urges an end to lockdowns in the adoption of a focused protection strategy to address the covid-19 epidemic he has published 135 articles in top peer-reviewed scientific journals in medicine economics Health policy epidemiology statistics law and public health among other fields he holds an MD and a PhD in economics both earned at Stanford University Dr bhattacharya thank you Senator thank you for the opportunity to testify I feel a little bit out of place because I'm going to be talking about about how well we've done or to what how dangerous the epidemic is as far as patients are concerned uh I'll cite some statistics on that and I'll talk about the policy response but I will also return to the theme of the of the of the uh of the of this hearing which is on on the incentives to evaluate therapies especially therapies that don't have a a financial interest behind them uh so let me first start by with some comments on how dangerous covid-19 is at an individual level uh early in the epidemic the World Health Organization publicized a very misleading 3.4 case fatality rate that panicked the world uh the numbers misleading because for the typical person infected the usual outcome spans the range for no symptoms whatsoever to a mild cold to set the severe vile pneumonia if the media highlights and we've heard about in this in this hearing uh that's many infections are not identified as cases especially in the early days because they didn't come to the attention of doctors or public health authorities we know from a series of studies a specific SARS Cove II antibodies in the blood which provide evidence of Prior coping infections this is true and from these studies we can estimate the true covet infection survival rate because of a recent publication the Bolton the World Health Organization surveying 61 of these studies worldwide we now have a good estimate of the infection survival rate it turns out to vary by orders of magnitude by age that's the which is the single most important risk factor although there are others for people 70 and over the infection survival rate is 95 percent it's a deadly disease especially for older people for people under 70 though the infection survival rate is 99.95 let me say that number again 99.95 and with improvements in treatment and patient management like dexamethasone as we've heard about and also improved ventilator protocols these numbers are improving all the time and they could be better at the same time the harms of the lockdown are manifold and devastating including plummeting childhood vaccination rates worse cardiovascular disease outcomes less cancer screening deteriorating mental health the name is the few toes already high and it will get worse in coming years as more people come in with late stage cancer worsening diabetes and advanced heart disease that should have been identified and treated this year 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 social isolation the elderly is contributed to Sharp rise in dementia-related deaths around the country for children the cessation of in-person schooling since the spring has led to catastrophic learning losses with severe projected adverse consequences for Effective students lifespans according to CDC estimate 184 adults seriously considered suicide this past June one in four among 25 to 44 year olds the CDC reports a 26 percent increase in excess all-cause mortality relatively the past years even though fewer than five percent of the 2020 deaths in this age group has been due to cover 19. the two main planks of the great branch and declaration and the focus protection ideas follow logically from these facts for older people covid-19 is a deadly disease that should be met with overwhelming resources aimed at protecting them wherever they are whether in nursing homes in their home their workplace or multi-generational homes they should be prioritized for vaccines and we should be actively seeking widely available and effective treatments that we've heard in this committee for the non-vulnerable those who face a far greater harm from the lockdowns than they do from covid-19 infection risk the lockdown should be lifted and for those who so decide normal life resumes but what about better treatments for covid-19 patients I said earlier we've made a lot of progress in learning how to manage and treat the disease over the past months but I think it has been a lot less than it should have been strikingly the most useful advance in treatment involves repurposing a drug that is already in widespread use of entirely off patent the steroid dexamethasone which is effective at helping severely ill cover patients avoid a deadly and detrimental immune response as a professor of medicine my inbox is filled with scientists and Physicians who have ideas for similarly repurposing existing drugs vitamins minerals and other therapies for early treatment of covid-19 infection for many of these ideas there are good pathophysiological reasons and observational evidently they might work however there's no randomized trials to evaluate whether they work doctors are free to use them off label that is the FDA approve them for use for some past other indication but they lack a gold standard evaluation to the efficacy of outpatient management so most doctors will not use them so to me the question is before dismissing these treatments is effective because of lack of randomized evidence I think the question we need to answer is why have there been so few randomized evaluations especially large-scale ones of these therapies and for that answer I'm going to put on my Economist hat for drugs and therapies on patent a patent holder has a strong interest in running randomized evaluations navigating the drug through the fda's approval process by contrast for drugs and therapies with no patent holder no one has much interest in funding expensive randomized trials or working assiduously to move the FDA regulatory process for Rapid approval or even slow approval the bottleneck then is not the FDA it's the lack of a residual claimant for these drugs and treatment investigators working at academic medical centers may have a reputational interest in evaluating these drugs and as you've seen Frontline doctors have an incentive to find good treatments for their patients but they must find funds from somewhere for them and pharmaceutical companies typically have no interest in it in principle the NIH exists to solve this market failure That Couldn't should use its resources to help fund randomized evaluations these drugs for off-label purposes and it has funded some important drug evaluation work such as the study determine the right dosage and Metabolism of drugs prescribed for children on Covert 19. it's also funded some trials for for some for for drugs that for hospitalized patients for the most part though they funded throughout trials for on patent drugs the NIH has made comparatively little effort to catalyze randomized evaluations of off patent drugs from covid-19 Therapeutics by contrast the NIH has devoted considerable resources to Aid the covid-19 vaccine randomized trial studies even the highest profile randomized valuation dexamethasone was not funded by the NIH the NIH is the relative lack of interest in the rapid randomized evaluation of non-pattented drug represent the government failure that has likely led to worse covid-19 outcomes than we would have had otherwise thank you for the opportunity to testify thank you Mr Dr bhattacharya in a interesting display of closed-mindedness I I don't believe we have any Democrat Senators that really are inquisitive enough to even ask any questions of this distinguished panel I appreciate the fact that the senator and Dr Paul is here so what I'll do is I'll defer my questioning for for Dr Paul thank you Mr chairman I'd like to begin by apologizing for the juvenile diatribe from the ranking member science is about having an open mind science is about disputation debate evidence and it's discussed and the contention and the back and forth is how we determine what the truth is but if you close your mind completely to this and are not willing to listen I think that's how science dies that's when we say well the government consensus or the scientific consensus is this well that's that's the closing of the scientific mind and that's a recipe for a disaster science is also not about ad hominem and attacks so by attacking this panel without listening to it leaving in a huff and having no questions shows a small-mindedness a closed-mindedness and really it should be everything that we should avoid I'm not here to be an advocate for one treatment over the other and I will ask some tough questions to the panel but I'm open-minded enough to listen to their side and see and try to determine whether or not it's a good treatment or bad but to immediately close our mind I think it's a bad way of looking at this I had a good friend die yesterday from this so I'm not one who's saying this isn't a deadly disease um she lived a couple doors down and we're sad Kelly and I are both sad about what happened um about six months ago we had a friend who died in their 30s not from the disease but from lack of a stress EKG she died from a terminal arrhythmia in her 30s with two young children but her stress EKG was canceled because uh the government decided that we shouldn't do it it was an elective procedure it was delayed and she died from a terminal arrhythmia so people do also die from the decisions that people make the most important thing is is no one person is right the panelists are not all right and people should question them and go back and forth and we try to figure out the truth from that but it's a mistake to say that one person should have all the power to determine what we should do when we place too much confidence in government doctors such as Dr fauci Dr Corey mentioned that he mentioned in June about steroids I mentioned it in March when Dr fauci came into my Committee hearing my first thought about the final pathway here with covet in the end stages is it's not too dissimilar from other final Pathways of adult respiratory distress syndrome I had a friend who's a surgeon who got the strep eating flesh from operating on somebody who had it and a blood splatter he got it the chance of losing your limbs is like 50 to 70 percent it's like a 50 chance of losing all your limbs I mean it's a devastating disease but one of the final common Pathways like covet is your blood vessels leak fluid into your lungs it's a sort of a toxic shock kind of syndrome uh they treated him with high dose steroids and so I raised my hand to Dr fauci and said do you think steroids might have a role in this and he sort of dismissed me and said that the studies were showing that it probably wouldn't work but I would think most people would argue now that one of the most significant developments in the acute care of the covid patient has been the steroids actually and trying to get them the steroids before they've gotten into the the full ards syndrome um some are even getting it at a very early stage in in the disease but that came from people asking questions being skeptical and not letting one doctor such as Dr falci say oh that's not right young man go sit in the corner we need to have an open mind I'm not saying I'm always right I'm about AI standard I'm not an expert included but I try to ask the important questions one of the questions that I'd like to ask and I think this is the difficulty of proving the situation on either Ivermectin or Hydro hydroxy core hydroxychloroquine is that because so many people get better you know the control group might be 99 of the people get better then you give hydroxychloroquine to this same group and you might get 99.5 per it's going to be a difficult thing to actually prove in trials that you get a benefit it sounds like in some of the sicker patients where you had a mortality um you know where you had a 25 mortality down to 15 percent that does sound significant now you're getting into the sicker patients with the outpatient studies one of the critiques is that so many people get better naturally how are you proving that it is statistically significant and what comes to my mind is sort of like when we wanted to prove that aspirin taking an aspirin a day was good to prevent heart attacks it took like 10 years and 10 000 you know people in the study because it was it was just hard to show the differences of whether an aspen worked or not I think the same thing is true with either hydroxychloroquine or Ivermectin in an outpatient setting is that because so many people get better on their own the converse is when you're really sick because almost because it's hard to get to to treat people who are very sick it's hard to prove that anything works when people are very sick but I guess what I'd like to do is open it for the panel one by one to explain how we answer the critique that most of these paper people are getting better anyway so how you've proven that your treatment works in a group of people who didn't go to the hospital so that you're selecting out actually for the people who may well then you know did you prevent them from getting seriously sick or have you selected out as your patient pool because they're outpatient tending to be people are going to get better why don't we uh we'll start with those who are here we'll start with Dr Oscar and then we'll go to Dr Corey and let me quick interject because we have such low participation take whatever time you you have for whatever questions you have doctor uh thank you very much senator Paul and I appreciate your your introduction I'm not appear as a politicism here is a treat her I'll be very practical and I'll defer to Dr Corey from his experience as an intensivist my clinical approach to patients are that they have symptoms that I treat them early and I typically restratify patients getting uh LDH levels lymphocyte counts and other other blood panels whenever possible I when I've used hydroxychloroquine I've and and oftentimes cybermectin I've had patients go to the hospital if I didn't have an EKG or another good assessment and I've always clinically evaluated the patients I've treated but I wrist stratify them uh you you may or may not know a husband and wife couple that I know Dr John Senator Johnson knows who I treated the wife and not the husband because I didn't deem the husband to be sick enough to Warrant treatment although perfectly safe to but his wife was much sicker so I think this has to be to some degree left in a discussion of the clinicians in terms of the data I provided the clerk of this committee Miss Kilbride PDFs of numerous clinical trials on many of these drugs not limited but including hydroxychloroquine Ivermectin vitamin D zinc and a few other uh medications and those trials are there but the fact that we've had third world countries Second World countries that have been more Innovative and have outperformed us in terms of survival I think is something that warrants uh questioning and it's one has to wonder if our bloated research academic bureaucracy has been excuse me has been more of a hindrance than a help during this Health Care crisis but I'll turn this to whomever I hope that satisfactory Dr Corey senator Paul I appreciate your question and it's it's critical the the the the content of your question which is how can we tell when something's working when many patients get better and there's only one answer that and we know what that is and it's one of the the central tenets of science which is you need a control group you need to have a group that is comparable to those that you treat and then you compare them to those that you don't treat what I am trying to message today is in our manuscript we now have 11 randomized controlled trials every one of those controlled trials show that in the Ivermectin treated group lives are saved there's less need for hospitalization there's less transmission less case counts it is a fundamentally and powerfully effective therapy against covet 19. we need the NIH to review these data we have the data let me say the amount of patients and those randomized controlled trials the 11 trials total nearly 4 000 with over half treated with Ivermectin let's remind ourselves that the treatment of covid-19 fundamentally changed after the recovery trial was announced in June that was a trial of 6 000 patients two thousand were treated with steroids and it showed the dramatic and life-saving properties of corticosteroids almost overnight the treatment of covid-19 changed as a result of that trial that was the recovery trial I am presenting a paper today with more patients treated with Ivermectin with larger magnitudes of benefit than the recovery trial I will maintain Ivermectin should be the standard of care of this disease based on these data it's not my opinion it's the data we have the data if you give anyone else a placebo based on the data that's in our manuscript I I believe that would be malpractice and you would lead to the to the heightened risk of death no more Placebo is needed so the 11 studies are inpatient or inpatient and outpatient they they vary so the randomized controlled trials I I almost can't describe what this data shows people need to read the manuscript we have four randomized controlled trials in prophylaxis each and every one highly statistically significant patients or people even citizens healthy citizens on Ivermectin do not get cold and you're comparing it to Placebo in these studies you're considering yeah so in in the prophylaxis studies alone which is four they took covid-19 patients who tested positive for coven 19. they identified their household members they gave them Ivermectin so they had a whole group of household contacts of covid-19 patients who took Ivermectin the other households they didn't give Ivermectin every single randomized controlled trial shows that in the households that were on Ivermectin drastically reduced rates of transmission the they did not the households did not get sick you can protect people from this disease with Ivermectin that's just the prophylaxis trials the outpatient trials so the outcome tested was how many people were positive turned out positive were positive or how many people got symptoms and they were drastically statistically significant these are and from multiple centers and countries around the world that's just the prophylaxis we also have trials on early outpatient as well as Hospital the most dramatic is the hospital each almost every single one we have four large randomized controlled trials in the hospital all statistically significant reductions mortality Dr Ryder has a large observational control trial from Broward County and he's here on the panel today in his trial he also showed the same the patients who got Ivermectin died at far less rates and opponents of using ivermectum had they responded to these critique these has there been a generalized argument that they make or has been silenced so the opponents again I want to call attention to the NIH and their recommendation I don't say that they're an opponent they made their last recommendation on Ivermectin on August 27th which is either 10 years ago or four months ago I don't know which August 27th this was their recommendation we recommend against the use of ivermectin outside of clinical trials that recommendation was based on expert opinion only there was no data to recommend or recommend against it was an expert opinion well I'll be happy to join with the chairman in sending a letter to try to get an evaluation if we could go to the same question if we've got Tom Newman why don't we go to the rest of the panel and ask the same question the the problem sort of from my perspective still being how do you determine an outcome of something that when you do nothing the vast majority of outpatients actually get better also started Dr writer thank you for allowing me to speak so to clarify something people talk about asymptomatic patients but I have kind of stopped using that nomenclature I call them pre-symptomatic patients we do not know offhand which one of these asymptomatic patients are going to develop severe disease and become symptomatic that is problem number one problem number two when I put in my written testimony and also during my early testimony I talk about the early intervention and treatment to decrease viral shedding and viral Transmission in the home setting and that is currently believed to be the largest numbers of people getting infected or getting infected in the home setting so that means a 20 or 30 year old may do fine but not cons Christmas there is a family meeting and that asymptomatic individual now infects other family members including their 70 80 90 year old grandma and now we have a real problem what we do know about Ivermectin is that it literally destroys the virus in most people within 48 hours so hence you take somebody who is asymptomatic not a carrier with the risk of transmission and you essentially stop that riding their tracks so you don't have an issue about that person now contaminating other people down the line or you significantly decrease that risk so that is really even a very different spin on that question that would ask no to continue as far as the data you're right sir Senator it will be difficult my team currently has a study in place we have the protocols written ready to go the only limiting factor was to get funding I've tried everywhere getting the funding is extremely difficult what we need to do is a large study a large randomized control study to confirm the findings to prove to the naysayers you know what here is your golden standard now the study that I did was a observational study but it was propensity match that is the highest standard for a non-randomized control trial and even there it shows tremendous benefit you spoke about the reduction in the overall mortality from 25 down to 15. well if you look at the overall mortality in people with severe lung involvement that went from 81 down to 39 that isn't that is even a more dramatic decrease in even these more severe uh individuals it is a safe drug a track record that is phenomenal 3.7 billion doses administered so I think we need to do those studies with the help of the NIH CDC or any one of those Regulatory Agencies a study like that could be implemented within 30 days but within another 30 days from that we could have collected all the data within another two three weeks from that we should be able to have answers if things are moved forward through the Regulatory Agencies we couldn't have our answers before this tragedy even worsens Dr Balboni great thank you and thank you senator Paul for the question I think I'll speak to the trials that we're running for about a peer review of broad spectrum antiviral targeting RNA dependent RNA polymerase we're running currently two large placebo-controlled randomized phase three trials in the outpatient setting early treatment and close exposure prophylaxis in addition there are two phase twos one at Stanford in the outpatient setting and and in long-term care as well there are observational studies with with thousands of data points um and hundreds of smaller trials having been run in many countries around the world we need to develop hybrid trial methodologies to combine all of these traditional rcts and observational study designs together real world evidence for for The Regulators if we don't cool all of these data we're going to see covid-19 in our rear view mirror we're going to quickly forget about it and all of these potential treatments are going to fall by the wayside so I agree with you we need to gather the data it will be large populations but we have to make that commitment the only way we can make these these these studies work is a true public-private partnership single companies as we've heard don't have the ability or the incentive to run these trials to have a peer review by the way is off patent we're doing that we're doing this at risk as a Consortium there's very little support for this kind of work and as soon as it falls away we've got to be beholden to our shareholders and our boards in the meantime as a physician I'm trying to do the right thing for patients um we need the assistance we need government help this has to be a whole of government approach and a commitment to going Beyond this immediate problem which is pressing and in our bases but to to do the right thing over the Long Haul to gather the data to uh to silence uh to silence the the criticisms of of these kinds of studies multiple small studies won't work as you correctly point out um so this is what we need um gather the data bundle it together and and make this available for future outbreaks and the last thing I'll say is that as part of our trials um it is true that if we were to look only at mortality data these trials would be unacceptably large and would take too long to run we have been working with The Regulators to look at time to resolution of symptoms similar to what was done with also tamavir or Tamiflu we believe that that is a a stepwise approach um but it but it's taking uh too long uh to to do this we don't have a whole of government approach um to this problem and so I so I asked the committee those present and those who have decided not to ask questions to just please internalize this message we need a whole government approach similar to what was done with vaccines to gather the data to do exactly what you said which is uh get to these large populations to show a difference so next Doctor Orient I see Senator Hall only on the computer so we're going to check to see whether he wants to ask questions but Dr Orient you want to answer that question uh senator Paul that's an excellent question that certainly applies to all types of research I would say if you have a really sick patient in the sense you have a controlled uh historical control in that patient if the patient is going downhill and you do something and the patient gets better then that that is evidence that maybe you did something right on the other hand if you have a patient is doing pretty well and you do something that a patient suddenly gets worse then you have to be worried that you might have caused that problem if you have a patient a bunch of patients who are healthy and they're going to do well no matter what then then I guess you really need to have a large study and we'll select with Ivermectin they they have done that they're they're of course many confounding variables and and then they're the ethical questions if you have something that's going to protect your grandma if it works and and doing nothing is going to put your grandma at risk then then are you engaging in some kind of human sacrifice to to use a placebo at what point does that become the thing some people have even suggested that maybe the RCT is outdated and we should be looking at other statistical approaches like Bayesian analysis so that we can get good data without running into this ethical ethical dilemma and and deal with with the need maybe to have combination therapies and to deal with confounding variables Dr baracharia thank you senator Paul for that question I mean I think that the the gist of your question is is right that this when you have an outcome that's relatively rare uh yeah you what you need is very very large samples in order to test uh whether the the the the and a control group to test whether the treatment actually works um you can get some indication with observational studies uh there are the difficulties that the treatment is not randomly assigned um but there are statistical methods to address that uh and the the great advantage of observational studies is that with these statistical methods correcting for this sort of a selection bias and treatment you actually can get very large samples relatively inexpensively so there's a procedure here I think we could follow uh I mean we could we could use uh data sets like the Medicare claims data uh other other claims data sets and other other readily available large-scale data sets to to check for for uh in sort of well-designed observational settings uh relational studies to see if uh there's some promising you know some promise to the kinds of treatments that people are thinking about and you could do this for many many many treatments in principle um uh you know lots of people with different ideas can check and then use that to inform what where the large trial should be run I mean I think that's that's one procedure there are others one potentially could follow but the the the the the the key thing I want to get across is this is that it is possible if you just choose to do it um and the incentives to do this have have not been great and as as a result we have much less information that we probably should have about the effectiveness of various uh treatments uh that you know that they proposed that we should that we should have had by this time uh in part also I think that's been driven by this group think that you mentioned that uh that has decided that there's only a small set of things that are going to work even before any of the evidence has been evaluated um I think all of that is to be regretted I think we have to we have to uh go back to our the principle symbols we know about how sound science works we have to we have to look at uh you have to do control groups you have to do uh studies but you have to have the incentives to run those studies or else they're not going to get done so Senator Hawley are you there but we'll check with his uh with his staff you know one thing I I think we lose in these discussions about observational versus Iran controlled studies is the the difference between a pandemic situation and a non-pandemic situation when you've got these off-the-shelf drugs have been prescribed safely for decades it's kind of like why not give it a shot I mean this it's a com it should be a completely different mindset and we just went the other way so do we have oh Senator Hawley thanks for joining the hearing go ahead yeah thank you Mr chairman um and thanks for holding this hearing uh Dr abatatoria if I could first of all I'm not pronouncing your name right just fine thanks thank you that's very adult um I I want to ask you about some of the points that you made in your written testimony uh which I thought were quite striking about the challenges of mitigation strategies particularly mitigation strategies that involve lockdowns full lockdowns of course we experienced in virtually every part of the country certainly my home state earlier this year that many have been advocating as a mitigation strategy again now you write about the the data uh that uh the the consequences of social isolation uh and deteriorating mental health that is associated with these lockdowns I was particularly struck by the CDC data that you cite that says let me get this right that one in four young adults seriously considered suicide this past June when much of the country was locked down that's a really stunning number and these impacts that you talk about and your testimony are really stunning so can you speak to the challenges that maybe young people in particular but but all Americans face from lockdowns as a mitigation strategy I mean I I think I think lockdowns as a mitigation strategy are a failure of policy imagination and they have been had absolutely devastating effects uh humans are not meant to live in isolation and that's that's the main focus of the lockdown strategies now I think there are some folks who are at high risk from this disease as I said older people some people with chronic conditions uh and so for instance 40 of deaths that happen in nursing homes there we actually do need to do some sort of isolation but we have to be careful there as well uh 20 there's been a 20 increase in dementia related deaths in nursing homes apart from covid there's a the key the key failure I think is a failure of Public Health to recognize that there's dangers other than covet heart disease psychology the psychological distress to young people is devastating we basically made them feel guilty uh for even for doing normal young people things uh I mean and as a as a result it's it's had as you can see one in four seriously considered suicide that number is absolutely shocking I mean I think it should shocked the imagination of everyone listening into thinking uh creatively about policy alternatives to lockdown the lockdown should be a very very last ditch effort not the the thing that we decide is we should do all the time I noticed that now even the World Health Organization which I have to say is a body in which I place very little trust um and for which given its conduct in this pandemic I have very little respect but nonetheless even the who I believe has now said that mass lockdowns as a mitigation strategy are are they don't recommend them I mean quite the contrary that they think the consequences some of which you've just outlined from these lockdowns are devastating yeah I mean I think there's an estimate uh that the that the UN put out uh in April actually I think uh this is saying that that there were 130 million people at risk of starvation as a consequence of the economic damage from the epidemic um I mean these are lies 130 million I mean that's that's uh you know two orders of magnitude more than the number of people have died from covert 19. um and to not account for that on a policy response I think is utterly irresponsible can you talk to me a little bit about some of the other health care effects associated with um lockdowns and decisions to cancel elective surgeries I know in my home state of Missouri many hospitals uh canceled elective surgeries back in the spring trying to prepare based on the data at the time for what they thought would be an absolutely massive Surge and even now and as we've seen cases Rising quite significantly across the country and again in my home state a number of hospitals as a precaution have have curbed elective surgeries and can some cases delay them which I totally understand but help us speak to if you could the the issues that come with the problem of deferred health care and when you have again especially in a lockdown situation when you have many tens of thousands of Americans millions of Americans may be deferring what would otherwise be fairly routine Health Care procedures Health Care visits what is the cumulative affected that over weeks and months as it builds up we're going to be paying until for that for for Gen for about for a very long time just just to take one example that's striking to me mammography mammograms to check for breast cancer decline by I think something over 80 percent Nationwide um what's the consequence of that many many women who would have been diagnosed with earlier stage breast cancers now will come in with late stage breast breast cancers in the in the next year uh and we've actually had made a lot of progress in in reversing mortality for for uh for breast cancer and other cancers in in the in the last decade that's going to get reversed with with 100 certainty as as the as basic preventative measures colonoscopies uh mammography have gone by the wayside because of covet I mean I think it's it's I mean I should just be clear because of the coveted lockdowns um I think that the uh Public Health should think about all of Public Health all of Health not simply one disease it's not Public Health not just about infection control I think that's been a major mistake that we've made all through this through this pandem very good thank you for that Dr Corey could I just ask you a question or two about social media you wrote in your testimony I noticed that one of the barriers to using already existing Therapeutics uh whatever they may be is an array of them uh has been social media and and you say that your pages in particular have been repeatedly blocked on Facebook I wonder if you could just elaborate on your experience with Facebook or any other social media on this topic yeah you know I I want to try to be respectful because I think the intention is correct the execution is unfortunately damaging which is my my guess at what the social media outlets and in particular it's Facebook um is that they want to cut down on misinformation right which is many doctors are out there claiming X Y and Z work in this disease the challenge is you're also silencing those of us who are expert reasoned researched and and extremely knowledgeable and so my group our Facebook page and again I I repeat we are some of the most highly published physicians in our specialty we've spent you know decades in academic medicine we're we're not just some random doctor but our group every time we mention Ivermectin we've been put in Facebook jail currently as of this moment our Facebook page is shut down to the point where we cannot post anything and we've asked the senator for help in that because we're trying to disseminate uh expert opinion uh heavily researched insights into the Therapeutics of this disease and we are unable to do that on social media and what what reason Dr Corey what reason have they given if any uh for putting you in Facebook jail I I don't know that we've gotten specific reasons but the the best that we can tell is that we were mentioning our vermectin so any claims to a simple solution and I by the way I'm going to stand by my professional reputation my decades in medicine and I'm going to tell you that I believe not only I believe but my group of doctors and there's at least nine of us who co-authored this manuscript we are telling the world this is the solution to covid-19 and it can be implemented rapidly however social media does not want to hear that from doctors and I don't blame them because otherwise you're going to have doctors coming along and saying you know I don't know soda water or this is the next solution so I understand the intent however um I I just wish uh some credibility would be applied to us and and and I I do I don't know how to solve that answer because I do think misinformation is a problem it is a deep and significant problem this in this pandemic however uh we are not propagators of misinformation oh is Facebook uh staffed with expert epidemiologists and infectious disease researchers to your knowledge not to my knowledge certainly not I mean should Facebook be the Arbiter of of what counts as medical research in your opinion I of course I don't think that they should be the Arbiters but I I but I I'm trying to be fair and I I do think they their intent is to protect people from misinformation however they are also blocking good information it's a very hard filter to put on and I and I I can understand their challenge I just wish they did better at it right well thank you Dr Corey for uh thank you for your work and thank you for sharing that unfortunately this is a pattern that we see with Facebook and the other social media Giants which have now decided that they will be the Arbiters of all information news journalism and the rest in the United States and that they will determine what counts as accurate reliable news research and everything else despite usually having zero expertise in any of these areas and by the way with zero desire for the American public that they should be deciding what we read what we consume what we learn about what we share it's really unbelievable Mr chairman uh thank you very much for holding this hearing well thank you Senator Hawley for participating well I want a quick go to Dr Ryder who's treated patients both in hospital and in hospital and also as an outpatient just to describe in human terms what happens to a coveted patient I think it is one of the more heartbreaking aspects of the disease that and quite honestly it's one of the reasons I know people that will not get tested because they don't want to become a coveted patient because they don't want to be separated from their family but can you just describe what's happened and and how we are people are dying alone and is that is does is that do does that continue to be necessary but just describe what happens when you have somebody going to the hospital take it from there yes sir thank you Senator so let me talk about the specific patient of a specific example because that's very Vivid in my mind and talk as loud as you can this is a lady that came in she was in her 50s no significant medical problems I believe she had slight hypertension and diabetes but everything was very well controlled um the lady was initially that was recovered when she presented and was a woman within a few hours she ended up on two liters worth of oxygen and that's the point at which I got consulted to help with her management over the course of the next 24 hours this lady went from two liters of oxygen all the way up to 50 percent of oxygen that is a very very rapid decline at the time the hospital was in lockdown meaning there were no visitors allowed into the hospital so this lady knew that things were going very badly for her um the medical staff was limiting access to the rooms because we had very limited PPE supplies so there she was with the disease that she was well aware of was quite Critical with no family at bedside very limited interaction with healthcare workers or nurses entering that room and I was there looking at her I'm like this is bad news based on my experience this lady would be facing near certain intubation and back in April intubation meant a 90 chance of dying so I call her son up and get a iPad into the room so they can FaceTime and have a discussion that support at which the sun broke down in tears is like doctor you've got to do something for her you got to you've got your doctors always have something they can do I'm like Sir with all the respect I have nothing else to offer luckily my wife who is also a doctor Dr sebelowitz writer had just read the article about Dr wack staff in Australia the day before and you know as the patient's family was pleading with me I'm like you know what we have this we have this one hope I don't know what to do with this there is no clinical data the dosing in that trial is not something I can administer to humans it's toxic and then it was like but it has other indications right I'm like yes there is and then we started talking about other indications they said you know what give it a shot try please I beg if you try so I got informed consent from him and some consent from her administered to drug and allowed to establish that connectivity between that family luckily that lady did very well she did not get intubated she went up to 90 oxygen but subsequently improved and was discharged through maybe a week later but you see that social isolation where those people are away from family and even today today visitors are allowed back into the hospital but they are not allowed into the coveted rooms that means that those patients are away from family and because of all the measures that healthcare workers need to take even now we still have a policy of limiting entry into the room for example the nurse will group all the lab draws and all the medications and try to enter the room maybe three or four times a day at most uh the residents which are part of the institution or ask not to enter the room um there's going to be one or two Physicians that are going to do the physical exam which is taken over by the other Physicians usually I'm one of those Physicians that has to enter the room on all these patients and expose myself but once again it is very very isolating for these people uh we now know that besides all the medical problems that covet causes the kidney problems the heart problems the lung problems we also know that it creates tremendous amount of problems with mental status these people their mind is not quite right and we have seen this a tremendous amount of anxiety so yes it has been emotionally draining both for the patients their families and frankly for healthcare workers as myself you know I have a young family I have a young wife and children and at the end of the day I want to go home and be safe and that's why I have become such a major proponent of early treatment because with early treatment I will not expose the healthcare workers including myself and my staff unnecessarily for these people now admitted to the hospital with more advanced disease and that's why I feel it's so critical to have that early intervention because we do know that treatment works much better better earlier on than later on and even later on you can see on my data that I published the results are quite staggering so Dr Ryder you just made a pretty pretty convincing case from my standpoint of why we should concentrate on early treatments because if we can we avoid that type of human toll Dr Orient one of the reasons I contacted or got in contact with you became aware of you was through Dr Lee valit who was early advocating early treatment in particular with hydroxychloroquine and your organization allowed me to get I think it's like 1300 or 1700 doctors very quickly signing a letter that was sent to the president United States encouraging uh you know doing something to allow doctors to have access to these types of drugs to use their op label prescription rights but I think one of the things that always impressed me about your organization aaps was is pretty simple mission statement so can you first describe that then also what you're hearing from that network of doctors that have the courage and compassion to treat patients early and basically and you know answer my my question I asked Dr writer about you know what was happening these coveted patients and is there is there a better approach well aaps was founded in 1943 to preserve private medicine and that means the physician is working for the good of his patients like it says in the oath of Hippocrates not for the good of the organization or Society or the political party or the advancement of science but each individual patient is the Doctor's first priority and the doctor has to have the uh authority to go along with his responsibility to that patient to look into the best best methods uh to communicate with his colleagues and sometimes or a lot of times you just have to guess about what's the best thing to do for your patients and to keep a careful watch on on what works best we found that of Physicians and independent practice are able to do this but once a doctor has an employer or he has a managed care plan where he's restricted to what's on the drop down menu then he his hands are really tied if if the NIH is the is the authority that their employer respects then then if he goes outside those rules no matter how much his patient needs it he's putting his uh his life at risk and it's becoming more and more we used to worry about um malpractice liability but that that's a minor thing compared with being period by your hospital in a way just to get rid of you that destroys your whole care career forever or of being before the licensure board because you deviated from the standard of care which used to be determined by what doctors in a similar situation rational well-trained people would do but now is dictated more and more by single authorities from on high who's whose opinions keep just getting to carry carried on along like the AMA or the Arizona medical association I'm learning about Ivermectin here Arizona medical association Arbor County Medical Society the AMA will say nothing about this and you ask about what are doctors doing and the answer is oh well nothing that's not not recommended by by the FDA so for a patient to have an independent Doctor Who is not under quite so much severe restrictions on what he what he can do is extremely important I mean occasionally a patient will tell me well I begged and pleaded with the hospital to do this for my my person with my patient husband who was dying please please give us some intravenous vitamin C and sometimes the patient's suggestion works I mean it doesn't always but if the doctor's afraid that he dared not do something that's even very safer that's even being critically trialed or has been reported in literature even if a long time ago that he will lose his job then he has every incentive to say well there's nothing more that I can do so keeping keeping this this option open for patients is extremely important thank Dr Orient um you know I I championed right to try and you know Dr Ryder basically that's what you you practiced in I mean you had a patient there you had to do something with that patient and the patient's son paid you to do something and he did something I think that that is exactly your right and and we certainly are seeing a different type of medical establishment where we have fewer doctors practicing medicine and more associated with these hospitals where they follow protocols which makes perfect sense but in a pandemic you have you have to think outside the box you have to do other things Dr Balboni I want to ask you because I I thought our phone conversation on Sunday was was pretty interesting you've you've been you've been in the FDA you've been uh physician in Department of Defense you've been in government but now you're you're on the outside um I really want to ask you two questions one can you describe why government doesn't have the incentive to run these trials we know the private sector doesn't they cost millions and millions of dollars and if it's a generic drug there's no incentive other than in government and and it should be the NIH or the CDC their FDA that advocates for all citizens for all patients regardless of you know the financial incentive but to look at repurposing drugs can you describe why that did not occur because one of the things we talked about is you know we had these drugs in our toolkit for a pandemic they you know I think Dr fauci talked about hydroxychloroquine um the drug that your company is trying to go through trial now those kind of in the toolkit it was designed for pandemics and it's all of a sudden we hit covet it's like that toolbox drawer was shut and locked and we ignored it so can you just kind of describe that that process and and the lack of incentives sure and and great great question um and I'll and I'll try and do so with the utmost the utmost respect for um uh my colleagues and former colleagues in government because I think at the end of the day people are trying to do the right thing and and I have to say that um and sometimes it doesn't always work out that way into your question about why we're working on Faba peer reviewer I first saw that as part of the Ebola outbreak in 2014 and it showed in effect in treating um Ebola uh and then everyone kind of forgot about it um and the the pressure to move quickly went away uh it was uh it's approved for pandemic flu in Japan it's approved for covid-19 in India and Russia it's it's it's likely to be approved in Japan for Copic 19 um imminently um the FDA uh is not moving as quickly although we're having very just very fruitful discussions with them um I think that um we are treating unfortunately many of these products um as if they were for chronic diseases and that may work well in a non-pandemic situation um and that's how that's the structure of these organizations is to is to review uh uh thoughtfully and take the time to look at to look at all the data and again I'm not suggesting we don't do that but in addition to that we have to push um these agencies uh there has to be a forcing function for Change and when under stress um I think they did they they they fall back on what they know which is uh uh reviewing and approving um drugs like cardiovascular drugs which which are which they can take more time with so I I think it there needs to be um both a forcing function for supporting their efforts to move outside of what is tried and true in their review process and I think you as as a committee and as as politicians have your hands on that lever whether it's policy or law there needs to be a forcing function to move them out of the ways that they do things which again worked in a non-pandemic situation and I would point to two things Senator Public Law 115 92. I worked on that as when I was with inside the dod that that was a law signed uh uh into effect in 2017 which mandates that the dod and FDA hold discussions and talks around regulated products that are of particular interest to the Warfighter and it puts them on an accelerated approval track it doesn't cut corners but it allows the regulator to devote resources to those kinds of accelerated discussions I would also point to a very recent development and politics notwithstanding it shouldn't matter a very pragmatic approach to doing the same kinds of the same kind of work as the result act submitted by by Senators Cruz and leak um and uh you know without having done I did some reading of that and it seems like a very pragmatic approach to push uh enforce some change on the Regulatory Agencies to move things along more quickly um I have to say the last thing I'll say here is I received 17 emails over the weekend and calls requesting compassionate use and single-use inds for further period of year I in the middle of running randomized controlled trials I can't possibly entertain all of those my colleagues many of whom you've heard today are treating those those patients I can't entertain all of those compassionate use single-patient inds so we have to move The Regulators outside of their comfort zone work with them to develop new policies and I'm hopeful that you and your colleagues with your hands on those levels can can force that policy and get them out of what they know um and start thinking a bit creatively in the middle of a pandemic and I'm quite sure that the results act I think I'm a co-sponsor that ties in very nicely with the right to try that that allows patients and doctors to use a drug that's approved by another body let's say the whatever the FDA equivalent is for the EU correct right so drugs that are approved in other well-established jurisdictions like uh Europe or Canada or Japan um for example uh would would it would uh it would move the the agency the FDA to uh to review and uh treat as as equivalent um that review and approval and so greatly speed the process of getting drugs available yeah I'm a big supporter of allowing doctors to be doctors and allowing patients to make these decisions because it's their lives or it's their families lives uh talk talked about other world bodies or other things that are happening globally in our last hearing Dr McCullough pointed out that the the death rate in India is about 95 per million in the U.S and other you know Advanced Nations it's closer to 800 per million uh I'm not sure who to direct this this question to but have are you aware of us actually studying what these other countries are doing you know one thing I've been struck is I've I've been kind of at the tip of the spear here so I get a lot of a lot of information I'm not a doctor but it's an awful lot of interesting information and one of the things that I have found out or heard is some of these less developed countries that just don't have the type of money to throw it at a medical system like the U.S all they have are these cheap generic drugs are are using them and doing quite well does anybody have some expertise to kind of speak to that that Dr bhattacharya Senator if I can have an opportunity after doctor sure sorry uh sure so I I you know I I think I've been reading the scientific evidence on this uh there's a there's a debate going on um about what exactly isn't it so part of the difference is that they have a younger population so that so for instance the low rate of uh mortality in Africa is almost certainly it partly due to that uh because that's so you know relatively few elderly um but also I agree with you uh the the use of other you know medications that that appear promising have to are certainly going to end up when I think could play a role in explaining why um places like India places like uh you know countries in Africa have done better uh but there's another explanation that a couple of other explanations that I've heard in the scientific literature uh again this is still all being sorted out uh is the is the prevalence of of cheap vaccinations like uh uh there's a vaccination called BCG vaccination which uh which this apparently has played some role at least that's the hypothesis that people put forward and there's some evidence in favor of that um in preventing bad outcomes from the disease and actually give them the disease you know at all uh and and the other uh the other hypothesis I've heard is the uh prevalence of pre-existing other uh of immunity based on based on um uh cross-reactive protection from other coronavirus infections right that so so there's higher rates of that in some of uh in many poorer countries um so I think all of those that we're going to sort out how much each of those explanations end up playing a role I don't think we yet have a definitive answer but I think that plus things that we haven't thought of yet are going to end up playing an important uh role in understanding of this look notice I didn't say lockdowns because in many of those places lockdowns are not uh not actually feasible as a long-term outcome and have probably not played a role in in a in in explaining why they've done better the lockdowns are luxury of the Rich and uh in a very expensive one at that Dr Corey yes so Senator um uh my organization the uh covet uh the front line uh covid-19 Critical Care Alliance we've worked with a number of analysts and two analysts that that are part of our organization have been doing uh numerous epidemiologic analyzes throughout the pandemic their data which again I have to say is free to share we can share with the nah the FDA so they can verify and validate the data but if I could go through that data very briefly right now I'd appreciate it I brought slides I will go through them very quickly they are visual and easy to understand do we have slides available on is this the one on Peru so yes and let's start with that because um Dr bodachari just mentioned something is that one hypothesis for why we're seeing lower rates is that potentially their younger populations I want to show data to show that that's not true in these it's the right slide yes number one this is only in patients over 60. we know the mortality rates in patients over 60 they are fundamentally different than in younger patients when you only look at Patients over 60 and you look at this slide this is in the eight regions of Peru eight states improve that initiated Ivermectin distribution campaigns throughout their population if you look at each graph the Shaded area to the left of the graph is before the Ivermectin distribution to the right of that shaded area is after they initiated Ivermectin distribution campaigns in each of the eight states you see what we call a temporally Associated reduction there's a peak in deaths a peak in case counts and a peak in case fatality rates which rapidly decrease to pre-pandemic levels this is powerful powerful data if you could go to the next slide the next slide uh I believe if you could show me uh that's actually a skip but I'll say this has been replayed we have data from many many countries on my website our analysts have numerous examples this is one in Paraguay there was a a state in Paraguay called Alto Parana the governor there got coveted his brother got coveted they took Ivermectin and felt immediately better and so they concluded that Ivermectin was a a was an effective treatment I'm not saying that's how we determine treatments but that's what they did the governor did something really dramatic he immediately began what he called a uh deworming campaign throughout his State because he didn't want to go against the federal health Ministry which was against Ivermectin in his State he began to distribute Ivermectin to the population if you look at that graph that's the blue one that's Peak and they rapidly decrease a month and a half later he found almost most no cases in the hospitals that was in Paraguay if you can go to another slide I can show are there any more slides that you have this these this is the one yeah this is in Mexico so the this is deaths in Mexico and the left side of the graph is before August 1st and the right is after the green shaded uh state is the state of Chiapas in Mexico in southern Mexico that state alone amongst all the states in Mexico decided to incorporate Ivermectin in its treatment protocols and if you look the case counts and these are widely available and and globally used uh databases of case counts and deaths you can see the deaths plummeted while in all the surrounding regions in Mexico the deaths either decreased only slightly or in the majority they increased so you were seeing this play out on population wide basis in many regions of the world if there's another slide please advance because your question and so here going back to Peru if you look at the blue lines and graphs those are those eight states that I presented whose regional health ministries decided to widely distribute Ivermectin the red bars refer to Lima the biggest city in Peru guess what happened in Lima the health Ministry of Lima did not employ Ivermectin in the treatment of covid-19 and if you can see throughout the summer and throughout this pandemic the case counts rapidly rise and remain high and only recently have come down but they're nowhere near the regions in which Ivermectin was widely used we have this data it's showing that we have an effective treatment against this pandemic I cannot over emphasize that okay thank you so I think I've got one question for Dr olski and then what I will offer is all of you an opportunity a couple minutes you know try and keep a couple minutes of just something that you still want to say that you haven't had an opportunity to do so Dr ask we have got a couple questions for you first of all asymptomatic spread I think I just heard uh that we have a 180 degree turn on that where somebody somebody uh announced that they really don't believe that asymptomatic spread is that big a deal or or and when we were earlier told that that is one of the biggest problems with covet is people that don't even know they have the illnesses while walking around they're spreading it can can you discuss what you believe is the current science on that well I think the current science and there's a large population-based study out of China that suggests that asymptomatic spread is extremely uncommon I think one of the reasons why literature has not uh clearly supported masking and I I'll review that my final comments uh as a significant preventative is that I think that early on we got it wrong as to what is the predominance method of mechanism of spread I believe what the Oxford University white paper by Thomas Jefferson believes in which I provided to miss Kilday the clerk of this committee that I think that oral fecal transmission much like norovirus and polio is a predominant mechanism of spread and that's one of the reasons why masking doesn't work and why asymptomatic spread isn't predominant so I think that I think that that makes much more sense the white paper is provided to to Ms kildaya provided to your Aid and I hope it'll be just summoned among members of the committee but I think the science behind that paper Tom Jefferson and the rest of the Oxford Group for the center for evidence-based medicine is is actually pretty compelling we've had that since March I think the ramifications of that are that aggressive use of chlorine-based cleaners and other things would really be very helpful in transmission and really need to be properly effectively promulgated so can you and again this isn't you know I'm not a doctor this isn't a you know medical class here but can you just describe the the biology in terms of covet and why some well this Ivermectin or hydroxychloroquine with zinc uh whether it's a family peer reviewer and probably mispronounce that but I'm actually doing better than I thought um can you describe in layman's terms how that might work can you lay this out Simply enough or is it just a bad question it's rather complicated to do so in a short period uh uh there was a penguin uh tissue model that a number of Chinese scientists published about uh that I read uh referenced in General Medical virology uh that showed that three drugs uh a a drug similar Ivermectin the drugs hydroxychloroquine actually local effects hydroxychloroquine's mechanisms is probably multifactorial it prevents a viral autophagy uh it also is an anti-inflammatory and has some benefits there uh there's also uh Ivermectin has some uh important effects as well and but but there is strong basic science in addition to the clinical studies that I presented to uh your Clerk and which uh Dr uh Corey has referenced that uh suggests mechanisms for significant efficacy I'll provide that uh separately and as an addendum to my customer is it safe to say that all these you know off-the-shelf generic drugs in some way shape or form the the limit or halt the viral replication well mechanism going down since 2005 that zinc uh was an effective uh inhibitor foreign cleavage an important mechanism that makes these viruses more uh virulent uh that's something that our Fort Dietrich colleagues published and then do didn't do much with uh but there's there's good literature that suggests that zinc itself is very effective I personally recommend to my my patients that all of them take 50 milligrams of chelated zinc a day if they can tolerate the dyspepsia and to keep their vitamin D levels over 30. there's significant data a very nice study in the U.S large study as well as one out of Israel that if one keeps one's vitamin D3 level over 30 that one cuts the relative risk of getting covered by 50 to 55 percent so it's a simple Public Health methods man have to measure that could be undertaken easily so let me ask of all these things that people have talked about you know zinc vitamin D vitamin C quercetin Ivermectin hydroxychloroquine famipirivir uh are there any real dangers I did talk to Dr Balboni on family for you know certainly you shouldn't give it for to women that are pregnant I mean so but these other ones how safe are there is there really any danger at prescribing these at the proper levels uh the short answer in other words in other words to give it a shot I mean as opposed to doing nothing which is what NIH guidelines is right now is there go ahead the short answer I think is there there is really trivial if any risk at all the reality is is that our our academic colleagues who have not discussed vitamin D in some of these other interventions aren't but it need not be a binary Choice obviously we don't have to decide hydroxychloroquine versus remdesiver versus vaccines we need all hands on deck uh what I would say is that uh there's some nuanced arguments about quercetin uh I I think it's the data about vitamin D toxicity is Trivial and really most the real problem is vitamin D deficiency Dr quarryan's testimony mentioned that two groups in the United States have been hardest hit African-Americans and Hispanics African-Americans 81 percent of African-Americans in the United States suffer from vitamin D deficiency sixty percent of Hispanics 40 percent of caucasians nursing home patients notorious for being vitamin D deficient military service members also are known to be vitamin D deficient you'd think they're they were studying themselves on these aircraft carriers but obviously quite the contrary I think that we should follow the example of the National Health Service in the UK and Scotland which is currently Distributing Vitamin D supplements to their elderly they've been doing that for a couple weeks now why we are not pressing this simple Point while we go over these other issues uh fills fails to meet my level of understanding okay well can I answer your question so you've said repeatedly and you and I have a a strong kinship on that approach which is foreign does it hurt to try so what are the risks of treatment with these agents and I'll tell you in medicine as a physician every decision I make therapeutically it involves exactly that question which is a risk benefit analysis and so if the therapy I have is either low-cost low resource or extremely safe and it's potential for benefit is high that would be it would win the risk benefit analysis and you should be given and I think that is what you've been arguing and I tell you with this age with these agents the answer is unequivocally yes when you look at the mortality and mobility of this disease which is unparalleled we are seeing countless deaths and it's it's horrific the way they're dying and you look at these safe and low-cost agents it seems like a no-brainer that you should try it and here's the thing about ivermetic going back to Ivermectin because you know this that is my message today that it is the cure for this character by the way you support Ivermectin right of course you're not confused about that right Senator so you have to understand something about Ivermectin 3.7 billion doses have been administered since it was first developed in 1987 3.7 billion something like over 60 percent of Subs around Africa takes it on a yearly basis it has an unparalleled safety profile with almost no side effects the only side effects that have been attributed to it are those that are considered to be part of the diseases they treat which is the ridding of the parasites and so so given the amount of evidence that I've presented as well as the safety profile on a risk benefit therapeutic analysis you cannot come up with a credible argument to not give it well address of chloroquine I think in testimony Dr risch talked about tens of billions of doses of that I know in the US kind of because I was concerned when we first started talking about that it was a legitimate concern if everybody started using that in the U.S or worldwide as a prophylaxis you couldn't produce enough and so people with lupus and rheumatoid arthritis may not get it so that would be a legitimate concern and maybe require our government Advanced and ration Okay so but you know what I thought was uh was was interesting about it is I kind of lost my train of thought I'll move on um let's let's go to the uh my final round of questioning we'll start with the Dr bhattacharya and by the way real quick because I want to ask you uh I've got a new testimony is very two things are very Stark and now you know you mentioned this with uh Senator Hawley the 130 million people that the UN study showed we're going to starve to death because of the economic Devastation of the shutdowns that now the World Health Organization says we shouldn't be shutting down and yet there's so many Governors that are still pursuing that path the other one was and this is I I don't think is in your testimony I saw this in another writing um I've certainly been following I've I've actually uh in a couple of op-eds talked about the case fatality rate versus the infection fatality rate I've been monitoring what the estimate is the prediction is from Oxford Center for evidence-based medicine for for months now they've been predicting the infection fatality rate is going to be somewhere between 0.1 and 0.4 I think now it's 0.1 and 0.35 you talked about in in an article about these several prevalent studies uh 82 of them now are kind of pointing to a 0.2 percent infection fatality rate uh seasonal flu and I've printed this out printed this out from the CDC website a bad year is about 0.18 so just a little under that again I'm not downplaying covet is as senator Paul talked about people he knows as those of you who've treated it's a deadly disease and particularly for over 70 uh five percent of the people with covet die from it okay or with it so I'm not downplaying this but I think it's you have to look you have to look at those numbers and ask how what have we done and what is the human toll of our actions on a disease that long term it looks like it's it's certainly worse than the flu but is it that much worse to cause that much economic Devastation with that severe human toll 130 million people starving and of course we heard all the other follow-ons but anyway Dr bhattachary if you have your closing thoughts uh sure thank you for this opportunity for to testify and thank you for that uh that lead up I mean I think the the um it is worse than the flu but it has very different properties than the flu older people uh have a much higher rate of death from this than uh than than younger people which is a different I mean the flu also has that pattern but not quite so pronounced that means that we should have a different uh but the the most striking difference how he dealt with the flu versus how we deal with this is not actually uh in the treatments and all that I mean there's obviously vaccines and other things that's that's different but the most striking thing is that in the case of the flu we do not induce panic and in this case we have Panic has been part of the policy it's been part of the lockdown I think has caused an enormous harm um it's it's a violation of all the that I've ever learned about public standard standard Public Health practice which is generally a reassure the reassure the public provide good good information and seek to develop good treatments and preventative activities instead we've just panicked the public um Let me let me close by just uh remarking on how civil and interesting this conversation has been you've heard disagreement a little bit about among us but we've been talking about hypotheses on complicated issues and uh I mean I've learned from the from the panel I I think this kind of conversation ought to be the standard instead of this sort of closed mind like we heard from the ranking members or the closed-minded decision that experts have decided what what the truth is and we just stopped conversation I think so that means I think that only just uh note that the second thing I want to and and I would end with is um we talked about how should we do evaluation in the midst of a pandemic versus in the midst of uh normal times I mean you think there's always this trade-off of of risk and reward in in this when we when we're deciding whether our treatment works and we're telling patients or or public health authorities that what we should we should adopt this or that that thing we want to have the best possible information uh available same time uh even outside of a pandemic if you're really sick you really and there's not a good treatment for you you would like to be able to see uh things that that you know generally you wouldn't use because you know the reward from the potential reward from it working is so great and really there's no cost but much less cost because you know you're you're uh you're you're a great risk already um I think the major problem is the the structures we have in place to do this kind of Rapid evaluation and develop evidence they're not a sufficient incentives in place uh to to do this kind of evaluation that said in my opening testimony um uh but and I think this for for both economic reasons and sort of government failure reasons that that that's true uh we absolutely have to fix that we need a system that allows for this kind of conversation uh formal conversation with opposite with up with rapid evaluation of observation using operational data uh rapid funding of large scale larger scale studies for the most promising things um to to be done sort of all the time not just during a pandemic and I I hope that uh the pandemic one thing one lesson we come up come out of it is uh let's be more humble about uh about the the whether expert opinion actually can be correct and instead uh be more open to novel ideas even one that's that seem to some part of the experts as not not actually going to work well let's try it let's let's do studies around it and then decide and on that basis make decisions as opposed to just closing off to date uh all together as as we saw sort of the ranking member try to do now listen it amazes me how these hearings have been attacked you know really how close-minded this has been how how you know our colleagues have boycotted this uh it is pretty amazing to me uh Dr Orion I actually did remember what I was leading to in terms of talking about hydroxychloric when I just wanted to ask uh it was originally approved for anti-malero correct that's correct and it's never been FDA approved for what it's primarily used for nowadays because and of malaria uses is small in comparison to its its application to rheumatoid arthritis and lupus those are off-label applications and it works and so we're just suggesting maybe it might work for covet too why not why not give it a shot but do you have and by the way I've got it voted in about 10 minutes so if you can kind of stay within that two minute uh constraint I'd appreciate the new closing comments but Dr Orient and that's exactly right that uh it is off-lably used for many many things about hydroxychloride there are graphs of that that look quite a bit like the grass for Ivermectin that when when countries like in Brazil one part of it uses hydroxychloroquine and the other part really forbids it you see a big difference in the mortality rates and the most impressive problem was in Switzerland when mortality rate went up when they stopped using it because of the terror provoked by that Lancet study that was withdrawn and then it came down again when when the Swiss went back to using it so I think both drugs have a lot of potential and sometimes patients respond better to one than to another the big difference between India and the United States Bears repeating you know 10 times higher mortality in the US and Western Europe compared with third world countries part of the reason maybe the age distribution but part of it may be sunshine and less vitamin D deficiency in India and Africa I wanted to follow up a little bit on the poisoned thing that Dr John made a big deal about in the last tiering of Dr McCullough answered it quite quite competently but just to reiterate that Dr Shaw was concerned that the rate of Poison Control Center reports for hydroxychloroquine went up doubled actually it went up from 35 to 76. but if you look at hand sanitizer there were 33 000 hand time hand sanitizer reports to the Poison Control Center which is an increase of 73 percent and for acetaminophen which everybody recommends that you take instead of some of the drugs that might help you there were 50 50 000 cases of just exposure to that alone and another 23 000 in combination and 65 and 42 deaths respectively but people are terrified of the cardiac effects even though reviews have shown that hydroxychloroquine may actually protect the heart rather than be a danger to the heart and if you're worried about the T intervals you'll have to worry about a lot of common antibiotics and antidepressants also which we don't one other thing I might mention is just to somebody mentioned the oral fecal transmission which I think is very interesting that's been coming to light back in the SARS epidemic there was a cases of of that broke out in an apartment build I couldn't figure out why and it was probably because of the flushing toilets putting aerosols into the ventilation system maybe this has a lot to do with it maybe instead of putting masks on everybody we should be putting Lids on the toilet or pouring Clorox into it before you flush it and I think our epidemiologists have not been doing a very good job at figuring out just exactly how does the transmission occur so that we can be sure that our mitigation methods are targeted to to the means we're going to go back to all this I think doctors need to use their own judgment and look at all this all of these things I think I read an article about the high pressure flushes inside hospitals might be a problem Dr Balboni again a couple minutes please sure thank you and thanks to to you for your support in 17 years in the Army uh I've lived by the by the The Motto one team one fight fdod everybody became an ebola scientist or physician everybody became a covid-19 uh uh physician uh at usamered as they tried to fight this there's an urgent need to develop um a hybrid trial methodologies new approaches to public policy and and I think from my perspective most importantly to fit the regulatory approaches to the threat that we're faced with in this case a pandemic if we fail to change our approach and develop an appropriate and safe use of of these drugs including oral antiviral Therapeutics we're going to be having this conversation again for covet 20 or 21 or virus X it is unfortunate and I've seen it already um we can't continue to send 170 000 cobit positive patients home with the hope that they'll be okay it's it's just not going to work so we we need in closing your assistance and the continued leadership of frankly this entire committee and the whole of government to to finally build this toolbox and so I thank you for reaching out and and thank you to all of my colleagues here that have testified um and and I hope the message has come across I hope they're not vilified for doing so Dr Corey yeah so I'll be brief um uh at your request Senator uh two things I want to mention uh this is not the flu I've been a doctor for a long time I will tell you from the earliest onset in this country in New York in one major Health Care system that I helped work with they went from 95 ICU beds in a span of two and a half weeks to 350 ICU beds gastroenterologists were taking care of dying patients on ventilators we do not do that with the flu I have done nothing but take care of covid patients since the beginning we have icu's dedicated to covid patients on ventilators that is not what happens with the flu the last thing I want to say is again I'm just going to reiterate because repetition is key the amount of patience in the randomized controlled trials whose results are now available and again they've come out recently they're emerging I I don't want to attack the NIH for getting it wrong they didn't necessarily get it wrong they're just not keeping up with the data my message today is that the recently emerging data has enough randomized control trial uh patients enrolled for they exceed the recovery trial but change the face of treatment of covet if you look at the summation of all those trials Ivermectin has shown itself to be a highly effective preventative and early treatment agent it needs to be immediately adopted systematically nationally and globally period and by the way I just want to clarify I'm in no way shape or form downplaying covet I didn't want to get it I don't want anybody get it I understand how serious and I was just making the you know the data comparison uh Dr Ryder thank you chairman for allowing me to participate in these hearings um as a Frontline provider I've been treating covet pretty much every single day since since the onset um I've only had pretty much seven days off since December 31st every other day has been taken care of the school the patients in the hospital this is heartbreaking this is really difficult initially we had to fight to get what I deemed appropriate treatment at the time now I have the endorsement of the medical staff at my facility who are using these medications out of the endorses about my colleagues who have seen the response of this medication Ivermectin is effective it's effective in early disease it's effective in late disease it's effective in prophylaxis it's an oral medication you do not need to monitor anything there's hardly any interaction you can use this medication in just about any condition with the exception of people on warfarin it is safe and expensive widely available manufacturers are able to bend what production of this if need be besides the U.S it's something that could be implemented as a World Health Organization measure the data is out there the unfortunate thing is that we need more funding to be able to provide more studies to look at people that are still naysayers we need to get people at the Regulatory Agencies to review the current data to see how effective this is to talk to people that have been using this in certain areas for example compared to geographic area where I live and work with my colleagues to other areas in Florida sea reduction makes a difference very easy to do but I implore you Senators to really help us Frontline providers to get us the answers we need I think we have the answers but to prove it to make other Regulatory Agencies come on board do not chastise positions that have been thinking outside of the box because honestly the box has failed us the medications that were promised to be the game changers to date have not done so from that severe convalescent plasma to just name a few we really need to attack this together and we need to try to save as many people as we can because I cannot continue to stand by and see hundreds upon hundreds of people die in hospitals thousands of people hundreds of thousands of people dying across the country this cannot this is not sustainable and there are easy solutions inexpensive Solutions and it's time for people to start taking a second look at it and finally believing that this data is real that it works thank you for giving us an opportunity to talk about this well doctor thank you for being compassion for treating patients and and I would argue yes money is definitely a problem but the root cause is closed minds Dr osui I just want to make I want to thank the committee uh civil you Dr Paul and everyone who actually attended this meeting for allowing me to speak I did want to hit very briefly on a comment that Senator Peters made and then ran out and have a chance to respond uh you showed us in English or a New York Times article uh that uh quoted me briefly but tremendously out of context about masking and I want to say the foundation for that was actually an article published in mid-november and the New England Journal medicine run by Mount Sinai at Paris Island with the Marines and I'm going to read briefly uh some from my notes the study found that 16 of the recruits tested pause for kova 19 upon enrollment within two days of arrival despite them having been quarantined for four weeks beforehand another 24 tested positive seven days after the arrival on the base this study says and 11 more recruits tested possible on day 14. just five participants reported any symptoms another 26 recruits who did not participate in the study tested positive so despite a hard quarantine including two weeks of supervised confinement and then forced social distancing and mask protocols you got a higher transmission rate not a lower one this is not common sense substantiated by science this is not a road map to success so to recap hard supervised quarantines do not work even when under full-time supervision for two weeks at a closed College Falling by two week more weeks of self quarantine quarantines are ineffective Mass do not work we've done that actually for 40 years even when a military supervised boot camp environment with enforced mask wearing they were in effect effective social distancing says work even when enforced by the military and boot camp with a six foot separation is worthless to prevent infection I think in other words all the claims of so-called interventions and mitigations such as uh referred to by the minority ranking leader do not work when tested on the most favorable set of conditions where compliance is monitored and reinforced by Marine boot camp instructors that's the end I think of the discussion on these matters and to paraphrase the New York Times that's the settled science in reality the second thing I would refer to is Dr about a chair's comment about lockdowns I absolutely confirm concur with him that lockdowns are inappropriate there's one time that we've done lockdowns previously like this and that was in Mexico in 2009 they abandoned them within a month because they caused both economic and medical Devastation lockdowns don't make scientific sense I believe they go against the who's 2019 pandemic guidelines and as we've seen it has thrown tens of millions of Americans out of work and have devastated this economy to further continue it I think is does not make either military scientific or economic sense thank you Senator well thank you and again it seems like we have this pandemic Playbook that we just threw out the window and as I said before I think the root cause of our problem is just closed minds yeah I mean people always preach preaching me like you know follow the science I think I do I've got a very open mind you know I realize that the the term settled science is a very unscientific term it is uh we keep again we practice medicine we keep advancing it but you only Advance it if you have an open mind I'll never forget uh in my previous life I used to listen to a radio talk show uh medical doctor Dr Dina Dell and so many times he would say when you hear hoof Prince think horses not zebras sure I think what has happened here is the people in the agencies that they're all they're all thinking zebras they're out they're all looking for the Silver Bullet solution the Exotic new biological medicine you know the perfect vaccine when we've got a herd of horses that are just there you know plow horses that can be used and they're safe and they're cheap and they just might be incredibly effective as you know Dr Corey's talking about ivermect and others have argued on hydroxychloroquine and others why don't we look at the herd of horses Senator tens of thousands probably hundreds of thousands people have lost their lives because we took the eye off the ball we we refused to look at the obvious and try and embrace what would have been the dream solution something available something cheap something that would work why didn't we give it a shot that that to me is the question of this hearing and I really have to go vote so

Channel: The Hill

Views: 40,205

Keywords: Senate Homeland Security Committee, vaccine, Dr. Jane Orient, Coronavirus, COVID-19

Id: MGboD4KAgbM

Length: 147min 51sec (8871 seconds)

Published: Tue Dec 08 2020