Transcripts For CSPAN2 Senate Hearing On COVID-19 Outpatient Treatment 20240711

I thought it was and i originally set out the title of early treatments for covid essential component of a covid solution. It was inevitable was inevitable that the coronavirus pandemic would be politicized and this is a tragedy that it was paid from the start i knew it was impossible to have a perfect response and we are facing a new virus that caused an entirely new disease. No one wanted to under react and as a result i fear the tendency would be to overreact and create Unrealistic Expectations regarding our ability to stop a highly contagious pathogen. The challenges facing us were daunting and our National Strategic stockpile have been reduced during the h1n1 pandemic and had not been replenished. It took time to develop reliable tests and even more time to Scale Production to meet the demand. The fact that a large percentage of people that become infected exhibited no symptoms made the coronavirus even more difficult to detect and contain. I have tried not to criticize the elected officials that have had the response ability to make very tough decisions with limited and highly imperfect information and others have not been so reluctant. Perhaps my background in manufacturing taught me to be more understanding of those forced faced and deal with very difficult situations. The members of this committee had a front row seat to governments response of the federal and state level. We have participated in dozens of Conference Calls a multiple hears with Agency Officials who have worked 247 to respond to an unprecedented even and it is always easy to criticize but i can, for one have been so pathetic with the challenges they faced and highly appreciative of their efforts. As we are all aware the coronavirus is not going away and even though it appears an effective vaccine may have been developed it might be available in record time people will continue to become infected and sick four months to come. We still need to develop effective therapies, particularly in the very early stages of the disease and it is on this point that i will continue to be highly critical of our collective dereliction and not robustly explain therapies designed to stop viral replication and halt the progression of the disease. We are are all aware tamiflu is only effective when prescribed early enough to stop the flu virus from left replicating and before the patient becomes too sick. Why havent federal agencies and the medical community applied the same logic and approach to the coronavirus . This question has baffled me since march and probably is not a single explanation. We do know coronavirus was politicized and used as an effective weapon in the president ial election and they included off shelf supplements and widely prescribed drugs and the cost of these therapies is well under 50 versus a brandnew drug, rammed a severe, the cost over 3000 can only be used in hospital and there does not prevent hospitalizations in the first place and good big pharma have played a role in discouraging less costly alternatives . I think the answer seems pretty obvious even though their methods will no doubt remain obscure. This hearing is not about emoting any one particular therapy over others and all those are quick to watch the tweets that it may be unavoidable but i have to say the absence of any serious nih study or consideration of hydroxychloroquine either by itself or in correlation of other drugs and supplements is worth discussing. This is a drug that has been safely and effectively used to prevent malaria and treat lupus and Rheumatoid Arthritis for decades during the doctors who had the courage to follow the hippocratic oath and use their off label prescription rights to treat patients using hydroxychloroquine had been scorned and state medical boards have threatened to withdraw the your license. The same has happened to pharmacist filling prescriptions for the drug in some states. Those using offtheshelf drugs be used off label to treat Covid Patients and will they suffer the same fate . Since the onset of this pandemic by public he advocated for allowing doctors to be doctors and to Practice Medicine, explore different therapies and share their knowledge in the medical community and with the public. I believe international, federal and state medical agency and institutions have led us down. I feel too many have been close minded bureaucrats potentially driven by conflicting interests and agendas. Tragically media and the social media have failed to ask the right questions and censored what they do not understand and my public advocacy has connected me to doctors who care and who are trying to compassionately help their patients in spite of the bureaucratic roadblocks they have encountered and over the last month have been included in an email Group Advising over 250 practicing physicians from all over the world sharing their knowledge and experience and the members of the group are here today and to me it is obvious that we should robustly explore every possible treatment to combat this pandemic at every stage of the disease. Why has there been such resistance to lowcost offtheshelf therapies that might stop the progression of covid19 and help keep people out of hospitals and intensive care units. I hope todays hearing can answer that question and provide direction on how to correct this glaring blunder that is cost far too many lives. I just want to make a couple other points. A personal story to make a point. My first child, my daughter carrie was born with a serious heart defect called [inaudible] and her aoda and pulmonary artery were reversed. First day of life a wonderful man, doctor john thomas came in the middle of the night at 1 00 oclock in the morning and performed a bloom sect tacitly and they cap raised her heart, shoved a un inflated balloon through a hole in the chamber of her heart and left the blue note open and pulled it back and ripped a larger hole so her blood could oxygenate until she was old enough to have the surgery which occurred eight months later with another incredibly skilled surgeon, doctor john a full kerr and we baffled the echo chambers of her heart. At the time they were someone was using [inaudible] and the surgeon had developed a technique using pericardial tissue so it can grow at the heart and my daughter is 37 years old today and him mother and two children and a Nurse Practitioner in the nicu. We had a wonderful result because i had access to doctors and two treatments produced by previous doctors to Practice Medicine and i dont think there is a random controlled trial or that schumacher re baffling technique. These were skilled physicians practicing medicine but what i find over the last eight, nine months in dealing with this issue is we have fewer practicing doctors and more doctors the following protocols which is entirely appropriate and i completely agree with practicing protocols and using random control trials. There are moments in medicine and in our history where you have to allow doctors to Practice Medicine to develop these therapies and that has been history, quite honestly of the development of medicine. My final point is to talk about the bill and championed through congress, right to try. Now, Current Situation for example hydroxychloroquine is not a prime example of a right to try because hydroxychloroquine is a fully approved drug which right to try says if a drug has gone to the first two stages of fda approval so its been proven safe but it hasnt gotten through the final efficacy approval, a patient in a doctors still have the right to try that if there are no other available treatments. Isnt that the position we are in an early treatment . There are no other treatments and yet doctors who have had the courage to Practice Medicine and try things like hydroxychloroquine have been scorned and worse. It makes no sense to me whatsoever and im glad there is a vaccine but that vaccine will not be widely available for months and more people will get sick and more people will die and i come up for one, are for allowing doctors to Practice Medicine to treat patients compassionately as fairly as possible so they dont progress into the hospital and the intensive care units. Senator peters. Thank you, mr. Chairman. To our witnesses for being here today we look forward to hearing your testimony. We now have lost more than 250,000 americans to the coronavirus and the United States is now the first country in the world to reach more than 170,000 confirmed covid cases in a single day. Those numbers unfortunately are continuing to rise. In my home state of michigan positivity rates rose to almost 12 and we have lost 439 michiganders to this pandemic and just the last week. In order to successfully tackle this pandemic our response must be driven by recommendations from Public Health officials that are rooted in science and transparency. It will take an all hands on deck approach to ensure that americans receive the most Accurate Information on how to protect themselves. Unfortunately, this information and disinformation continue to run rampant. That is why i introduced legislation to create a covid19 disinformation and Misinformation Task force that would work to slow the spread of unfounded information and in the process save american lives. As members of congress we also have a responsibility to ensure the information we present to the public is accurate and rooted in science. Americans must be able to rely on and trust the independent food and Drug Administration and centers for Disease Control and prevention. Political interference and misinformation undermines the hard work that dedicated scientists and experts are carrying out at these critical agencies. We must also be careful of giving americans a false sense of security by promoting untested and unproven outpatient remedies and we all want answers that will keep our families healthy and safe but im concerned many of the treatments that will be discussed today have been presented as panaceas for the coronavirus. It would be irresponsible to give americans false hope for these types of treatment will be enough to keep them safe and lou of other measures that are scientifically shown to slow the spread of coronavirus. Our nations top scientists must be able to do their work without meddling to ensure the both treatment and vaccines for covid are saf and effective and are trusted by the amecan people. Unfortunately, this demonstration has continued to exert pressuren our governments top Public Health agencies to water dow Health Guidance and even promote unproven treatments further putting americans at risk. These actions have also diminish the publics dominance and eventual Coronavirus Vaccine and treatments and from theery start of the pandemic the president a others in the administration have consistently undeined and questioned Public Health experts at the food and Dr Administration and the centers for disease contr and prevention. They have pushed uroven treatments instead of leading by example and practicing simple measures that we know prevents the spread ofirus like wearing a mask and sial distancing. We made some of in the new in the covid authorizedr approved vaccine will not likely be widely available for man more months. We must coinue to use masks social distancing contact raising and other measures for the foreseeable futur to protect our friends and our neighbors and to stop the spread and ultimately, to saveives. Thank you, mr. Chairman. Thank you, senator peters. It is the tradition of the smitty to swear in witnesses so if you would all stand and raise your right hand. Do you solemnly swear the testimony you will give before the committee will be the truth, the whole truth andothing but the truth, so help you god. Please be seated. Our first witness is doctor peter auliffe and he is the current vice chair of internal medicine at Daily University Medical Center in professor of medicine at texas and mp he received his md from the university of Texas Southwestern Medical School and his mph from the university of michigan. He has fortified by the american board of internal medicine in the areas of internal medicine, cardiovascular disease but he specialized in the trim and a patients with medical problems and have major effect and major organs including the heart and kidneys. Doctor. Thank you, chairman johnson, Ranking Member peter and members of the committee for allowing me to talk to you today about the critical need for ambulatory treatment as an emergency measure in the middle of this national crisis. As we sit here today we have the greatest mass of infected americans that weve ever had since the start of the pandemic and americans are pouring into hospitals untreated, the hospital census is already at capacity and a National Calamity of unimaginable mortality is right around the corner and in a matter of weeks to months americans will be horrified with what they see on the news with respect to hospital overrun, mortality skyrocketing from both covid and non covid convocations and conditions and in patients further infecting other as this pandemic spirals out of control. My viewpoint and my views expressed here are those of my own and not necessarily my institutions but my viewpoint is this pandemic should have always been viewed as having four pillars but if can bring up the figure of the first pillar is contagion control. We have had probably the vast majority of government efforts solely focused on contagion control. The entire media representation of what the government has been doing has been on contagion control. As we sit here today it is obvious contagion control has not solved the problem. The second pillar is early and treatment in this virus infects individuals and they sit at home for two weeks but we have a to b opportunity to treat this problem. We hear nothing about it. We hear nothing about early ambulatory treatment and there is no updates and there is no viewpoint to americans of what is going on outside of the United States for early ambulatory treatment is a standard of care in countries that are doing much better than the United States trade is grossly overlooked and i think the third pillar is a hospitals but they are overrun and were doing all with the best technology can in the hospital but hospital is an inadequate safety net. The current hospital mortality rate is about five7 with patients getting the icu is 25 and virtually all the covid deaths that occur occur in the hospital. It is obviously not an adequate safety net for americans. The fourth pillar is vaccination but vaccination should bring out the close of the pandemic but this hearing is about early ambulatory treatment and we can bring up the next figure. We learned a lot about the virus in their been over 75 peerreviewed publications since the onset of the panama information is flowing in at about 500 papers a day and any expert who claims that a review of data and studies are quickly out of date and i can tell you with this pandemic and this virus what we learn is an early viral revocation phase followed by destructive immune activation caused and then blood clotting from thrombosis. What doctors have done is innovated and theyve identified both in the hospital and outside of hospital aided by Clinical Trials and observational studies and approach that involves accommodation antiviral followed by corticosteroids and anti [inaudible] doctors in the outpatient surgery or calling for help. The doctor is one in new york and in the middle of a calamity in york there was an early into vader. I summarized these and publish them in the american journal of medicine and the synthesis of the principle of randomized trials and observational studies and this algorithm has been updated multiple times and provides a framework for new drugs and agents to be incorporated in the early ambulatory treatment approach. I reviewed every report from realworld data from amecan doctors who have innovated and faced this probl. I can tell you that they are achieving rates of hospitalizations a deaths us than 3 for high risk americans and over 50 with conditions and st doctors can achieve less than 1 . With no treatment in the United States areow individual over 50 with medical problems faces 7 rate o hospitalization and death. Someone in the 80s that skyrockets to 4 and i can tell you as a doctor i have always treated highrisk patients with the best tools available and i looked at the evidence and when it was obvious that that drug did not work i did not use them but hydroxycut lauren, if i had to say [inauble] and i compare with other drugs and then steroids and that should be nine controversial but doctors should be using corticosteroi and sword fed as well as blood thinners. What doctor would not help a patient wh is at risk for a catastrophictroke that occurs as a competition of thi condition . I can tell you right now im not asking for permission to do this but im asking for your help. Im asking for the government to organi all Government Agencies that are related to thiso assist doctors rapidlyith their innovation a their Compassionate Care of patients with covid19 at home because we can present hospitalizations and death and right now is the onl on the table. Thank you, doctor mcauliffe prayed our next witness is doctor harvey risch and doctor risch is a professor of epidemiology at the Public Health and Public Health yield school of Public Health and the yale school of micine. Doctor risch received his md from the diversityf california san diego and phd in bio mathematics from the university of chica. Authored more than threaded tourney five original Research Publications and member of the Connecticut Academy a sciences and engineering and he research the efficacyf the seven outpatient medications for the treatment ofigh risk of a 1942 hospitals across brazil. Doctor risch. Senators and colleagues, thank you very much f coening this hearing. We all understand the endemic disease we are facing and that we have to face headon and not hide fm it hoping that it wil go away so i will ge you my perspective on this. It may of this year i observed the results of studies of a drug suggested to treat covid, hydroxychloroquine being miepresented but what i thought at the timeas sloppy reporting. We heard from doctor mccullough how covid disease proesses in phases from viral replication to pneumonia to multi organ attacks. Viral replicatn is an outpatient condition but then monia that fills the lungs with immune stem debris and is lithreatening is hospitalize a bull. Weve also heard how each phase, each pathologic expert of the disease has to have its own specificreatment and how those treatments are derived from the biologic mechanisms of the disease and thus i would frankly astounded at the studies of hospitalreatments were being represented as applied to outpatients and in violation of what i have learned a how to treat patients inedical school. We are now finally coming to address why ove theast six months our gernment resurgence initute have invested billions of dollars in expens, medications a Vaccine Development but all most nothing in outpatient treatments with e first line of response to this pandemic. Its not that weve lacked medication studies but we had a number of problems but i think that the early on conflation of hospital with outpatient disease serve to imply the treatment of outpatient disease has been studied and found ineective. This illogical premise motivated me to look at what the evidence or outpatients disease and treatment were. I want to reiterate that we are considering the evidence for early treatment of high risk outpatients to prevent hospitalizations and mortality. That is it. Im not talking about inpatient disease because thats a totally different consideration but only about outpatient disease. This is treatment starting in the first five days or so after the onset of symptoms and treatment of older patients or patients with chronic conditions like diabetes or obesity, heart disease, lung disease, Kidney Disease and immune system diseases, survivors from cancer and so on. These are the people who are most likely to die from covid and they are the people most in need of prevention protection. In doing my research i sought to obtain reports of every study of every medication pertaining to early treatment of high risk outpatients. I monitored literature daily which is a task and what i found is remarkable. What i have observed is that positive reports of the number of drugs and every study of the outpatient use of one particular drug, hydroxychloroquine, with or without a pumping agents has shown substantial benefit in reducing risks of hospitalizations and mortality. Now the studies breakdown is a e double blinded randomized controlled trial that various government and scientific personalities say provide the strongest supposedly the only trustworthy form of evidence. The second is nonrandomized but still controlled trials. There is some truth to that assertion about the nature of the quality of the evidence. There is also much falsehood and we know for example the great majority of drugs used to treat heart diseases were established before randomized controlled trials. With nonrandomized trials. Cholesterollowering drugs were widespread use before randomized trials were ever done and the most common antibiotic used in children was used was not established by randomized controlled trials. The great majority of drugs that are in use today are not established when they went into widespread use for the randomized trial and many had randomized trials later but this talisman and use of drugs is not always done on the basis of randomized trials but on the study with other kinds of studies. Thus the idea that only randomized trials provide trustworthy evidence is a simplistic notion that sounds good in theory and perhaps doctor johns may tell you later its what many doctors believe but this idea does not stand up to the body of medical studies and data that addresses it. In fact,. [audio difficulties] doctor tom freedman who was the director of the centers for Disease Control in 2017 wrote an extensive essay in the new england journal of medicine showing that nonrandomized trials and randomized trials divide proven compelling evidence in the equivalent evidence for the efficacy of treatments. Could you please enter the article into the record . Underlying this was a gigantic mega analysis of metaanalysis or what i call a mega analysis done by the Library Consortium which is a British Organization organized to form evidencebased medical research and the investigators examine what involves tens of thousands of study comparisons is the gigantic amount of data tween randomized trials and of corresponding nonrandomized counterparts. When they compared these two kinds of studies they found that they arrived at virtually identical conclusions and please enter the study also into the record. This evidence is why while performed nonrandomized trials are every bit as much of a Gold Standard today as the randomized trials youve heard of. This is empirical data, not opinion. This is empirical data. What did i find when i investigated hydroxychloroquine in early use among outpatients . The first thing is this drug is extremely safe, exceedingly safe. We know this from common sense and this is a medication that has been used for 65 years by hundreds of millions of people and tens of billions of doses worldwide prescribed without routine electrocardiograms screening and given to adults and children imparting women, nursing mothers and such a drug must be safe and must be safe when used in the initial viral replication phase of this illness it is, in fact, an outpatient initially similar to a cold or flu. And so, could you please put the oxford billing paper and its supplement into the evidence and this is a paper showing more than 900,000 hydroxy chloroquine users that show no excess mortality and no increase cardiac arrhythmia and also please put into record might article from the american journal. I discussed the paper. In spite of the safety surprisingly, in july the fda posted a warning against outpatient hydroxychloroquine use on its website and after they did this or at the same time the fda had no systematic evidence of adverse and the website itself says that it justifies the warning based on evidence that it had in hospital patients to justify it for use in outpatients which is what i said before was invalid. There are now seven studies of early use hydroxychloroquine and highrisk outpatient and every one of the studies has shown the significant benefits for this includes 636 outpatient in brazil, 119 clinic are shipped patients in france and 717 patients in a large hmo network in brazil and 226 personal patients in france and more 1200 new jersey and 100 longterm care institutions in andorra and almost a thousand patients across the country of saudi arabia. All the studies showed about a 50 or greater reduction at risk of hospitalization or death. In fact, the saudi study was a set of National Studies and demonstrated a fivefold reduction in mortality for hydroxychloroquine plus zinc the two used together versus zinc and standard of care alone. None of these studies has shown a single fatal cardiac arrhythmia among the thousands of patients that were treated in these studies that was attributable to hydroxychloroquine. In fact, in addition to this there have been six outpatient randomized controlled trials and weve heard a lot about this in these trials individually were small and incomplete and stopped early but together when analyzed together, as we did, they show statistically significant reduction in risk and that is what matters. That is that paper and if that could be entered into the record also. This body of evidence for hydroxychloroquine dramatically outweighs the riskbenefit rio for remedisvir and antibodies and using [inaudible] the fda has approved for emergency use authorizations while denying the emergency use authorization for hydroxychloroquine. This is an egregious double standard that fda did on hydroxychloroquine that needs to be overturned immediately and its emergency use authorization application approved. I restated that every outpatient study of hydroxy corcoran has shown benefits and there are no studies as far as i know of last night that our highrisk use in outpatients that do not show benefit at all. Now we spent the last six months with formal Government Policies and warnings against outpatient treatment and the government invested large very large amounts of vaccines and expense of new treatments with have yet to be proven while its been no support evaluating inexpensive medication and a quarter of a million americans have died from this mismanaged approach. Even if we find the vaccines eventually work effectively and safely as we all hope, myself included people will still get sick and die in early outpatient treatment is still and will be continuing an essenal part of ending this pandemic. Thank you very much. Thank you, docr risch. Our next witness is doctor george fareed. He is a family medical specialist in raleigh, North Carolina with over 50 years in the medical field and graduate with honors from Harvard Medical School in 1970 and thats two decades of teaching and researching academia and return to clinical medicine established at general practice but hes currently the medical director of Family Medicine specialist at pioneers Medical Center in Imperial Valley. In the past few months doctor fareed has treated countless, 19 patients both outpatient and inpatient and doctor fareed. Thank you. Mr. Chairman, senators and colleagues, thank you for is your microphone on . I hope so but can you hear me . Try to bring it closer bit by the way, all of your i know you have longer testimony and i know you have different attachments to that and all that will be entered into the record. Doctor fareed. Again, thank you, mr. Chairman, senators and colleagues, thank you for convening this hearing. I have a background in academic back on, research standpoint from work at the niaid as a professor performing research at Harvard Medical School after i graduated from harvard in 1970 and became a professor there and later ucla school of medicine about 30, 31 years ago i decided to go into clinical medicine which is my real passion and i chose a rural area where i thought i can make a difference. Ive had experience in that 30 years treating hiv, other Infectious Diseases and practicing primary Care Medicine provider in the hospital and my experience is in the covid flu stage and outpatients and hospitalized patients in the icu and made me determined to prevent the covid flu from progressing to the horrible, lonely kind of storm suffering that i saw in the icu and i still see it. We accomplish this with what i present here today and like Everything Else in medicine the goal is to treat early Covid Patients are difficult to treat when they get very sick. The Imperial Valley where i work or where we work became the covid epicenter for california in june and july. Since early march both in my raleigh clinic and doctor brian tysons all valley urgent care clinic where i also work over 25000 fearful people were screened over 200404 covid19 positive and we treated successfully over 1000 highrisk and symptomatic ones. The interesting thing to me is that doctor tyson and i independently came to the same protocol for that purpose back in march and we basted upon the great work from doctors the lingo and doctor raul and they are our heroes. It was a triple hydroxychloroquine cocktail, hc q3200 milligrams over five days and have the three myosin and zinc which is often left out of the studies. The cocktail was best given early as doctor mccullough has indicated within the first fiveseven days where the patient is in the flu stage and the timing of the drug is when the virus is in a very active National Replication phase in the upper respiratory tract and our goal has been and still is to prevent it from entering the lower risk respiratory tract and present hospitalizations and we achieved this in over 1000 patients and that was involved reevaluated at two, three day intervals and we blended in corticosteroid if symptoms warrant but generally did not and do not especially in the highrisk individuals and those over 5060 and those with core morbidities or with moderate to severe loose symptoms and we want to avoid the covid wrong syndrome in all patients that happens after they recover and because we do not need a treatment and i use this regimen to treat 31 elderly nursing home residents in an outbreak in june and 29 recovered fully and the drug works through multiple actions and through the gun and zinc and it blocks the signal one receptor and a several others antiviral thefts and the antibiotic has an antiviral theft and potentiate the action of hc q as additional anti covert agents become available they can be added to this regimen to enhance its efficacy and we are routinely now combining [inaudible] which you cocktail with excellent results. It is safe and has a different anti covert action. This becomes analogous to the use of agents for hiv treatment and multi coral antibodies will be suitable also when readily available and the culture is consistent and good often dramatic with improvement of 48 hours and we would not have stayed with this if it werent helping people and always reliable and weve seen hospitalizations on a single negative cardiac event and our experiences are aligned with all the studies that doctor risch just mentioned and let me be clear, this is only about the science and the science of viral replication and the science of stages of covid in the science why early treatment works and early treatment has led us to actually try to Committee Kate our approach and we think it should be on a National Level and we wrote a letter to colleagues to the president in a letter to congressman and a letter to the California Health department and open letter to doctor Anthony Fauci and a National Plan for covid19. As we describe in the National Plan this approach would be part of the solution to the pandemic, protect the vulnerable and it highrisk and visuals get sick, there is a solution for them with early treatment and with the antiviral cocktail. If early treatment becomes widely available people will be much more confident and going back to work and sending their kids back to school. Thank you. Thank you, doctor fareed. Our final witness is doctor [inaudible]. He is the dean of the Brown University school Public Health and practicing physician to help policy researcher. He received his md from Harvard Medical Schoolnd his mph from Harvard Th Chan School of Public Health. In 2013 he was elected to National Academy of medicine. He is a globally recognized expert on panmic preparedness reonse and groundbreaking research regarding the Ebola Response and now on the frontline covid 19 response ever. His research focuses on improving the quality and cost of Healthcare Systems wh a specialization of the impact of Public Policy on these systems. He currently cactuses as a general internistt preventive administration Medical Center in providence, rhode island. Doctor. Good morning, chairman johnson. Sorry i cant be there with you in person today but it i my honor to be a part of this hearing. As you have hearde are entering the most difficult days of this pandemic a so i am so pleased that t committee has met to discuss the value of outpatient therapy. Treatments that cane given early in the disease course and by treating people early we can prevent hospitalizatns and save liv. The good news is that there are outpatient therapies being evaluateand shod be hopeful and i am hopul that some of them will work. One area where outpatient therapy has largely not been used isydroxychloroquine. Earliern the year the fda issued a surprisingly early authorization use and subsequent data came in it was revoked because it became clear that hydroxhloroquine was unlikely to be effective for covid19. Wathe fbi testified [inaudible] i believe it was not. The eu as are contingent on three interrelated questions. First, suffient data to even make adjustments to he enough evidence and secd, to the potential benefits outweigh the risk and finally, will there be an opportunity to collect more data over time so we can refine any eua decisions. Hydroxychloroquine there was not sufficient evidence and the evidence that was they are certainly did not suggest benefits without weighing the risk the basis for the hydroxychloroquine e was from Laboratory Studies and really ultimate one small non randomized, non blinded study hospitalized patients in france findingshat were later discredited and the scientist was nowacing disciplinary actions. Since then dozen of studies have examined the efficacy of hydroxychloroquine and here is the boom line. Every single highquality study has failed to find any benefit of hydroxychloroquine for covid19. I have to say im disappointed and hydroxychloroquine is a cheap and widely available edison and had a fun and affected it wouldve made a enormous difference in this pandemicut unfortunately it isnt effective and it is not there is no clear consensus in the medical andcientific committee based on overwhelming evidence that hydroxychloroquine provides no benefit in treating covid19. This includes in the outpatient so lets talk evidence. A large randomized controlled trial published in the new england journal of medicine founno benefit of hydroxychloroquine given to outpatient with exposing to the sars covid two but recovery trials found higher rates of death among hospitalized patien for hydroxychloroquine but this included people who mptoms have begun within the past seven days that ely phase of the disease that the doctor mentioned and other inpatient tria have found results. There are outpatient highquality randomized doubleblind files and they have also fled to find. Doctor risch talked about observational studies we should talk about that. Can they be hpful . The answer is they can. We dont generly use tm for treatments because we want highquality data but it is possible to have highquality observational studies. Observational studies ruire controlled groups that are comparable and use sophisticated statistical techniques and look for things like natural experiments toelp us understand when sometng is likely to be useful. Im not aware of any observational sty of hydroxychloroquine that is a paicularly high quality and for every truly done observational study that sws benefit we can find poorly done observational studies that show harm. The way out ofhe lowquality evidce quagmire is to gerate Higher Quality data. It turns out history of micine is replete wh treatments that we all thought work that turned out and anecdotal evidence as i turns out is not actually evidence. The miracles of american medicine has come from applying rigorous scientific standards to our ideas and each time hydroxy clerk when has been subjected to such a task it has failed but let me make two more points as i finish up. One is im often asked by people well, in the middle of a crisis how can this hurt to connect fda issued eua for hydroxychloroquine in march of this year and in april it was 93 increase in related calls to the u. S. Poison controls and to his. These things can hurt and finally a word about the ua process. When the fda scientists are left alone to examine the science of the data process largely works. They understand emergency at the moment and the need for faster improvement. Authorizing therapies to the political pressure or with little to no data does far more harm than good. As a physician ive been troubled by the politicization of hydroxychloroquine and potential therapy we should study it and if it works we should use it and if it doesnt, we shouldnt. But i have to be honest, in the dismal failure of hydroxychloroquine to date there is little scientific basis that it will be effective for anybody and at this point in the pandemic was so much suffering and doubt we should focus our efforts on promising approaches to help americans get through this crisis. Thank you very much. Thank you, doctors. As i said i my Opening Statement i figured this wou not necessarily be as broad a discussion based on other early treatments ande will get into e dispute on hydroxy clerk went so i guess so be it. Obvisly we have a huge dionnect between testimony here and between experts. Harvard and yale educated doctors and phds. Doctor mccullough i note 93 increase in poison reporting found pretty scary and you had mentioned befe the hearing a little bit about what that is based on so could you talk about that and also i guessou had covid. He recovered from it and not totally but y tested negative so you dont present a danger but could youirst of all talk about that 93 increas in safety or in poison reportis and also just talk about your only personal expanse with your own treatment . Senator, i want my testimony to clearly be on the record that i think doctor ashish jha is reckless and endangers for the nation. His comments regarding the poison control reports is exactly what doctor peters is interested in but you are interested in this information regarding covid and that report in the middle of the pandemic when hydroxy clerk went early on was appropriately used that first wave of the pandemic is what kept it from rocketing and skyrocketing. Hydroxy clerk and was widely used early on and that is what cap the march, april and may curve down. When it was used we had 500,000 dose administrations and the Poison Control Center received i think the number was 77 additional calls and when the reviewer looked at it two thirds of them someone took an extra dose and they were concerned. It boils down to 17 cases out of over 500,000 administrations and yet doctor ashish jha holds up to the rec and public as a scare point to scare the public away from a safe and effective therapy for covid19. As you mentioned i had it myself. Im 57 and i got asthma and cardiovascular disease and i can tell you senator peters, i was not falsely reassured sitting at home. Believe me, when i got that test result i was terrified. Every american is terrified. Every older patients with heart and lung disease when they get the report they are not falsely reassured and sit at home and think this will be a picnic but they are scared to death by the time they come to the hospital it is frank a tear because they know they will be isolated and never see their family members again. What did i do . I did the right thing and i got myself rapidly into a fda approved treatment protocol through a study and hard to do, by the way because the government offers no resources to the public to quickly get into Clinical Trials and i got into a Clinical Trial and took hydroxy clerk when as part of a multi drug sequence program which is exactly what is in the peerreviewed literature which is the framework of how americans should be treated. While i was a few days behind to recognize what was going on the virus got into my lungs and i had pulmonary involvement and got anxious. I got to the point where i thought maybe i could be hospitalized and i can tell you firsthand this cocktail of drugs works for sure but hydroxychloroquine dose by dose settles down that fever and reduces the amount of the severity and intensity of symptoms and by that mechanism that is the reason why hydroxychloroquine reduces hospitalizations and deaths among patients get anxious they cant breathe anymore to go to the hospital so this isnt complicated. There is over 100 studies and they are all supportive. Eua says when the preponderance of evidence shows the drug works and has safety we ought to go. My view is we need to go with this and everybody highrisk in america. Doctor risch, when you listen to doctor ashish jha it sounds authoritarian so do you have a response connect. Yes, thank you. Ank you. I think that what i said early on about the conation of hospital with outpatient studies is apparent that there has been also studi and there is no doubt that there are plenty of hospital studies and some of those hospital studies in deed showed no benefit and it is not harmed there are reasons for that and i dont want to get into the technical sues of the studies but just to say its irrelevant. Study of hospital patients are irrelevant we are considering outpatient disease and outpatient treatment and treatment that starts in the first five days. There are only seven studies and doctor ashish j says they are t highquality studies but in fact, they are highquality studies and controlled studies and were passed out two randomized except that the patits chose whether to take the medications or not. With csulting with their doctors. You may say good that lead to biasesn the answer to that is yes but the bias i tha when patients are sk they are more likely to take the medication they a offered and not quite as sick but they know th got the virus they will say maybe i will just see how it goes and maybe i wont have to take the medication. What you have is the builtin bias doing worse to the people who do take the medication and its bite that butin bias the patients to do better in the studies in brazil and the various other studies also that bias there is an advanced fighting a benefit o the dog and in spite of that bias the studies show benefit of the drugs. Furthermore, the studies all measurell of the different variables about the state of the tients, both on the conditions and chronic conditions that they have about the progression of their illness and so on that reflects likely they areo be hospitalized or not independent of the drug and the studies that address that by wha we call statistical adjustment. Th studies we are not back in 1950 doing epidemiolog but back in 2020 doing epidemiology where we know all of these answers in the removing potential bias in the studies of these of the studies that were done and how they were analyzed. These are what studies show the benefit and these are the studies or the kinds of studies that Organization Consortium compared in tens of thousands of studies of modern epidemiolog studies compared those studies to their corresponding randomized trials and showed no difference. You cantabel these studies as poor quality studies and give a blanket on that if you want to stay a study in particular is poor at the original study of 40 patients in france that no one is now including that was the motivating study butot an evidential study that there is no one proclaiming these are for studies b good, modernist studies. The only difference is the randomization which is insad be addressed for and are shown by the analysis that they are equivalent to randomized trials. If we do need to stay in times of my seven minutes are up but i want to quickly go to doctor for rebate i would ask the witnesses to watch the clock as you are answering questions as well to save in time but very quickly, doctor fareed, do you believe you put in any of your patients at rk by treating them the way you have . As a docr who looks at patients with compassion, do you believe it wouldveeen better for you to do nhing and just send your patients home with no treatment whatsoever hopefully to survive this without having to go to the hospital . Coulyou comment on that. I am concerned for safety of my patients. Not ever wanted to put any patient at ris and i was concerned early, slightly, but not very much because of the results i researched and my colleague also, doctor tys, had taken the same approach so thaccident in question is i have no qualms and no concer whatsoever. I am very pleased to p the patient on the protocol ando enhance it with the other agents that we could blend in because i know they will get better and they are so responsible and so appreciative that its very gratifying, quite frankly but s almost like being i treat hiv patients and its been gratifying to treat hiv patients because they can go into complete remission but it wasnt when i started it was a fullblown epidemic and people dying right and left but now four, 19 im happy to get a call from kansas or someone else where their doctors are not providing treatment and to immediately call it in because i know its safe and only going to help. Thank you. Again, i believe patients, americans have the right to try these things and already have been fda approved for doctor peters or senator peters. Thank you, mr. Chairman. Number of questions for doctor ashish jha, since the start of this pandemic there have been reports of pressure by this white house on both the cdc and the fda to influence what should be independent evidencebased Public Health decisions. Doctor ashish jha, my question is what impact does political interference have on our nations ability to effectively respond to health emergency. Senator peters, thank you for that question. Science has always been bipartisan and weve seen the scientific agencies with the food and drug immunization, cdc, the safeguard from politicization under president bush and under president obama and this is these agencies have largely been left to do their job because we believe and we know the market people benefit when the best Scientific Minds apply their expertise to the problems at hand. I believe that in each of those in ministrations you could disagree with policy ideas but the fundamental underlying work of those agencies was always [inaudible] but that has been different and we have seen the cdc pressure not to speak out where the evidence has been clear and weve seen the fda being pressured around emergency use authorizations. What happened with convalescent plasma with doctor steven hahn going to the white house and saying things are clearly not accurate and everybody in the Meta Community new they were not accurate and it was baffling. It was exciting because throughout the entire of my medical career saying Something Like this is fda approved was a Gold Standard and meant it had gone through a vigorous scientific review and had passed that review. Those who words have become less powerful. I believe that the politicized nation of her scientific agencies has hampered our response and made it far less effective and one of the reasons why america continues to have one of the worst responses in the world with joy to 50000 americans dead and more than 11 millionmericans infected with this. Doctor ashish jha, last month i released a reportn the development and the distribution of covid19accines which found that the administration politicized nation of the covid19 rponse that you just referredo is actuay conservative to a sharp, sharp decline in americans perceptiveness to an eventual vaccine. My question to you, docr ashish jha, would you agree with that conclion and what can the federal government do to rebuild trus and ensure americans can feel confident that any vaccine authorized or approved by the fda is one that they should feel comfortable taking . Senator peters, i would first begin by talking about the whole Vaccine Development process which, i think, has been done with incredible scientific integrity and done extremely well. Overseen by this white house and i think the Science Behind what is happened in the partnership at the federal government and academia and industry has been a model for how we should behave. On one hand i think that has been terrific. What has gotten us into a bit of couple months is as election time was nearing you started hearing political leaders talk about having the vaccine before the election or pressures to get these vaccine before the election. I think that created a real concern among the American People that we were not going to use a scientific timeline but a political timeline to make a decision. I think the fda has done a good job and laid out criteria for what they would need to see before they were authorized the vaccine and when those criteria are met i expect that the fda will authorize vaccines and ultimately if we want to build confidence with the market people, whether democrat or republican, liberal or conservative what you want to know is are scientists getting to evaluate the data and scientific recommendations free of political pressure and if we can let the fda do that i think it will go a long way towards Building Confidence in the sexy. Doctor ashish jha, misinformation and disinformation surrounding covid19 treatments and vaccine runs rampant across the internet and americans clearly need to have clear information about treatments that have been scientifically shown to put the emphasis on scientifically shown to benefit patients and certainly not unproven remedies so that you can find on the internet. That is why introduce the covid19 misinformation and Disinformation Task force my question to you is what impact does misleading information about, 19 treatments have on the American Public . Senator peters, this has been a huge challenge but we are facinghe biggest global Health Public crisis of a century and has been compounded substantially by the ser amount of misinformation and disinformation that is out there. In order for us to have gone to is pandemic without suffering the staggering losses and suffering what we needed was a collective action paid what we needed was people pulling in the same direction, guided by science andvidence. When we have had things like politicized nation of [inaudible] we know that there is now very compelling evidee that people wear a mask in the right setting it c make a very bi difference. We know that social distancing can make a big differencen producing a we note that testing and trang can work and weve seen it inarts of the u. S. And in other countriesut the miss information makes it harder for people to know what is right and what is wrong. Killings. The fda has issued for ergency use authorizations for cod19. One has since been rescinded and another has been criticized as premate due to weak data. The gaoeport issued found the decisionmaking process for issuing these emergency youth authorizations lacke transparency. Do you believe the fdas process is working as intended and what tential reforms should we consid . So the mechanism is important because in an emergency, you do not need, nor do you necessarily want to wait for federal approval for these nonemergency circumstances. But whenever you lower the bar about it and use an alternative mechanism, in order to build confidence with the American People because a the end of the day it is all about confidence. Its all about trust. Wh you need in the process that is transparent and wha i believe we need to hear is less from the political appointees and more from the scientists and we need the clear criteria. And i think that those are Guiding Principles that we use. I have no doubt that w can build back all of the confidence that has been st in the fda, the cdc and other agencies. We he to go back to the First Principles o transparency, openness and letting the scientists do the talking and decision making. Thank you. Apeciate it, mr. Chairman. Senator romney. Senator [inaudible] senator cper. I will just go down the list. Senator hansen. [inaudible] is there abody on that call . To let the witnesses know mr . I will go to senator langford. Thank you for all the witnesses i appreciate very much your engagement and for the work on this. Ere are a lot of questions on the process and we have every confidence that there is work being done both in the Science Community and private sectornd on the federal side and quite frankly the states are doing what they can to try to help in the procs. The challenge we have right now is getting all these things up and its been a remarkable year for these things to move. Ch of what weve talked about today is an area that hasnt been discussed much and that is what can be done in the earliest phases of y virus at this point to be able to help diminish its effec or its replications. Weve talked lot about how to protect each other and wear a mask which is a good idea. Theres a lot ofesearch going on on what can be done in the hospital with blood thickening and organ and allhose things. What wouldou recommend for the cold and flu seasonhatever it may be that individuals should take and add to that what would be i addition to in particular whe we havwhat we have gained fs virus as well as we go tough this i just dont think theres been enough research and conversations about those aspects so i would be interested in the positions just answering those questions because i tnk that is the key issue what is typical for the normal virus and what are we finding helpful even if it is only a little bit what are we finding helpful. So i will let anybody take that in whatever order they want to take it in. Thank you for the question, senator. Let me say i think we should probably narrow the question to the serious and potential viral infections, so the acute hiv which is a serious proem, three to five drugs. Hepatitis, three drugs, for drugs, even shingles which can be a painful problem, to drugs. But the principle is always early. I cannot think of a single infection where the best advice is to wait two weeks before we start treatment in the hospital. That is the current recommendations. Americans are appalledy this. That is a great question and i believe its important for people to be proactive. We have learned a lot of what is good to help people. What we have recommended to the general population where i practice is applicable to helping protect against other viral infections at this time like influenza and that is a good strong multivitamin, a particular supplement 25, 15 to 25 milligrams a day. Vitamin d, three of the two to 5,000 today and antioxidants that help. But beyond that, i think that ive learned so much from the use of the cocktail that im convinced it is a Broad Spectrum that is so welltolerated. I see patients now that look like i treat them and they get better in 24 hours and then they are negative so theyve had another virus. Another virus or possibly influenza so we have learned a lot about the value of the Broad Spectrum antiviral that is welltolerated and i am a proponent of even making it useful influenza. By the way is it doctor jha . Thats what i thought. Just a different pronunciation. Do you want to chime in on this . Thank you for the questio antivirals are tough. As opposed to the antibacterial therapy, antivirals take a lon time to develop,bout 15 years to develop that were really effective and its taken a long time to develop them for hepatitis see and be and we do not have gd ones for most outpatient viruses if y think about the common cold which thankfully is no fatal but it can make you feel lousy for a couple of days, we do not have treaents outside of the supportive therapyf other things that help to manage the symptoms. Th are difficult to develop. I think we all agree there is no question on thisanel were among the entire community that findingarly therapies for the virus that causesovid19 is absolutely critical and would make an enormous difference. I had been early on very hopeful it would be one of those things. It just hasnt panned out and there is a lot of work going on and i think we should continue studying them and when the evidence of sething works we should use it and when it doesnt, we shouldnt. That is a helpful question here because of these vaccines coming out we have the vaccines the horizon quickly that could he be here by the end of the year wit fda pending fda fil approval and with this process we have four or in the queue at this point and that hope is one ofhe misinformation pieces that is out there publicly is i dont share that fro the oversight and if theres been no short cut in the science process on this and its going through all t studieand such, does anyone here have any concern on the vaccines that are coming out all, that they havent gone through the proper science . And means nobody has a concern. At least to be able to hear that, i look forward to those vaccines actually coming to the market and moving forward. Thank you for your opinions and i appreciate your insight. Senator carper. Mr. Chairman, Ranking Member thank you for what you do. About eight months ago almost to the day you said its going to disappear one day. Its like a miracle. It will disappear. That was february 207th, earlier this year. And since that time, a loss of 250,000 people in the country nephew, niece, 250,000. For 1908. 132,000 canada, 11,000. Mexico, 99,000. Add all of those numbers up and we have actually suffered more deaths since the beginning of coronavirus. Four times the number of men and women who died and this has been all year long done a better job of figuring out how to deal with it and we should be guided by science. Every now and then i hear a song on the radio. The song was she blinded me with science. One thing i hope that we can agree on, we need a vaccine. We need to be able to reach out to people. We have to make sure that its available and in great quantities. The second thing that we need to do is if 300 Million People get it administered to the people did we make sure that they get one shot or two shots, how do we do that and keep track and in a way that increases the confidence of the American People. It actually focuses on the American People and the second thing how do we figure out the Distribution System to be able to administer that so successfully. I want to ask a question if i could of doctor jha. You have talked about the need for the distribution by Public Education campaigns what steps we need to do to ensure they have what they need to provide the vaccines. This pandemic is going to come to an end and let us say we will bring it under control and we will do it through highly effective vaccines if they are distributed and accepted because the line there are many steps between a vaccine becoming available. I think that there are two broad sets of issues that really need addressed. First is getting states ready to receive the vaccine and to distribute the vaccine, to have a clear game plan for who gets it first and who gets it a second, with the protocols are going to be and how it will be distributed. Those are Critical Issues and theres a lot of confusion and lack of clarity about how all of this is going to work. That needs to be dealt with effectively and soon. Yesterday would have been a good day, today is better. Weve got to get going on that. The other part that goes beyond distribution is communicating about this. With the science and Scientific Evidence we all agree the scientific process has been done with incredible integrity and weve got to communicate that to the American People to be able to voice and help people understand and answer their questions about the vaccines. Most of them will step up to be vaccinated and that is how we will bring this. [inaudible] this is a really critical issue, senator. Theres a long history of distrust born out of some very troubling practices that have been directed towards minority communities, so these areas of concern are not born out of nothing. I believe the best way to engage members of the communities of color is through the direction of information and openness and transparency and engagement of voices because while the message is important, the messenger is every bit as much and so that does mean reaching out to religious leaders in those communities working through the evidence and data. We have to do other things like make sure that we deal with financial barriers and eliminate them and other logistical things to make it easier but its a combination of both the logistical issues and also getting trusted voices. I would urge us communicating, messaging thats a lot of work to do and we need to work togeer. Appreciate your question here and im happy to hold the following hearing what i will say i have heard it now said repeatedly weve got to convince the American Peoplehe vaccines are se. I dont recall anybody on my side of the aisle questioning the safety of the vaccine process. That seems to have come from officials of the other side of the aisle so if we ve to repair the damage it with folks on your side of the aisle have said. Can everybody hear me. Thank you and thank you to the witnesses for being here today and to the chairman and Ranking Member for holding this hearing. But i would like to start by expressing my deep concern over the decision to fire the director of the cybersecurity and infrastructure security agency. The director and his Cybersecurity Team helped protect our election infrastructure from cyber threats. Moreover, they did an admirable job of combating the plague of disinformation some sought to push to undermine the process, the bedrock of our democracy. It is to be commended and it is unwarranted and it makes our country less safe. The director directors firing e future would be a more appropriate topic in this committee than what we were focusing on today. Now turning to the topic of todays hearing, over the past two weeks we have received encouraging news of promising vaccine candidates. However even under the best of circumstances the researchers suggest a vaccine will not be widely available until ma mid2. Covid19 infections, hospitalizations and deaths throughout the country have skyrocketed and experts agree that we had a very difficult winter ahead of us. This should be to make evidencebased treatments and take precautions to keep themselves and their families safe such as practicing social distancing and wearing masks. As we learn more about how this is transmitted in the communities across the country, it is becoming increasingly clear the gatherings are driving much of this. We are currently seeing. Its understandable people feel comfortable gathering with friends and family they know and trust but im concerned americans are not getting the information that they needed to fully assess the risks associated in these types of gatherings. Can you talk specifically about why it appears that these smaller types of gatherings have been subject and what steps people should be taken to reverse the trend . When you look at where a lot of the spread is happening a lot of it is happening in peoples homes. The reason what we know at this point. That is the major risk factor and its been a long pandemic already and there is a sense that your home is your safe place. But when you invite friends and families you get to make the assumption, and i understand that. The problem is that there is so much a symptomatic spread of the virus without even feeling any symptoms at all and when you bring friends over, you get together and have a meal and share some drinks and the masks come off and thats become a major source. At this point the Critical Issues are about telling people where the risks are in helping people make better decisions. For these celebrations and other gatherings many others however are still struggling to determine whether there is a way to travel or celebrate safely. So, what advice do you have for those that remain uncertain about whether to travel over the thanksgiving holiday . This is one tt ive struggled with myself during thanksgivi we usually get together either with my inlaws or my own pares and i thought a lot about is there aay to do it safely and cannot figure out how to do that safely as much as i would love to see my family for thanksgiving i also wowant them around in 2021 and i believe with houseld gatherings with people who dont live ahome with you it i very hard to do safely right now and so i have come to t unfortunate conclusion that i recommend people n do that. They can get together outdoors if that is possible, go for a walk, spend Time Outdoors but the traditional just dont know how to do that safely this year. My family is making similar determinations, the group of 30 of us that gather isnt what we are going to be doing this year. Let me follow up with you for those that will be hosting if they do feel its necessary for some reason what specific accommodations and modifications to their plans do you believe are essential to mitigate the riskll you are doing to help keep americans informed and safe and i yelled back the rest of my time. I will give you a minute before i turn over to senator enzi. Listening to that last exchange of questions and answers i want my stimony to be clear. This entire hearing was about early treatment and what those last exchanges showed a complete lack of focus it went over the vaccine and then wandered over and what is being offered at the thanksgiving dinner. One of the reasons why america is failing colossally at handling the pandemic is a lack of focus exemplified by the exchanges. I think that its critically important that Accurate Information get out to the American People about what the science tells us about avoiding getting the disease in the first place and taking precautions to keep loved ones safe. That is the purpose of my question, and i thank you for holding this heang. Ippreciate that. Wh i have found though, the term disinformation thrown around in the hearing a lot, i know often times those accusing somebody of doing somethi or even more guilty of doing what they are accusin others of and i will use the disinformation as an example. I was accused repeatedl o the disinfmation and they established into the investigatory records, so i get a little tired of hearg all e accusations coming from the other side. On the credibility of the vacce its not republicans questioning the science into vaccines and credibilityf it, its democrats and need to put that on the record. Thank you, mr. Chair man. And thank you very much for holding this hearing. Its a different hearing than anything ive seen. And critically needed. Doctor jha, i want to thank you for the positive comments and the speed of the process for the vaccine. We seldom hear that. We never hear that from the other side. When the media wants a person to fail, there is a little recourse and if this had happened in a non election year, it might be totally different. Politics has played a role in this. They were shocking and said we were going to spend 15 billion solve the problem of aids a africa around the world. Now back then, 15 biion was a lot ofoney. Not anyre. But i got involved in that process and after it passed the house and the senate unimously, unamended, they sent me to see what the problem was. I got to meet with some traditional healers. We probably call them medicine men, the most powerful person in the tribe because ty can poison the chi and do their own autopsy but i asked them what theyve learned and they said we know we shouldnt bleed to people with the same knife. I dont think this was in acceptable method ofolving the problems but at any rate, if this had happened i think it would have been different. I appreciate youolding the hearing on what people can do when they first find out that maybe they are infected thats when we tried to do something even with critical things like cancer. Early treatment has been important. We havent h any discussions on the early treatnt. I appreciate all this infoation on the early treatmt. Some of it works and some of it doesnt and th is everything thate know about when you get sick some of it works and some of it doesnt but when people are thinking that maybe they are going to die, they would like to he some kind of a solution. Ey would be willing to try some things. But obviously good news doesnt sell because you dont see it anywhere. I see a state of panic mostly because until the vaccine comes out, there is no answer and it uses a pretty good study. Can you repeat once more with this cocktail is that youve been using and what the results have been. They consist of hydroxychloroquine its the actual algorithm promulgated by the association of physicis and surgeons and presents the details, but our cocktail may be a little bit different and theres flexibility it consists of hydroxychloroquine we found 320y period and then 100 milligrams twice a day from five to ven days and its very well tolerated 50 milligrams three times a day for that fiveday period. So thats it. Its simple and extremely welltolerated. How can people get these Early Intervention drugs, are they strictly prescription, how would you go about it . The doctor prescribes hydroxychloroquine and theres a growing acceptance among the pharmacies to dispense it. In any case the hydroxychloroquine is a prescription to the United States and other countries its overthecounter and there are countries now that our dispensing packets that they take home and that they provide offtheshelf to contain all of the components including another attractive agent for these purposes. But if they do not have it they can take the antioxidants that help bring zinc into the smell and that is the antiviral component of the treatment. But it can be taken three times today and that is overthecounter 500 milligrams but its much more effective with the agent that has multiple actions as an antiviral. Would you be willing to provide us with a copy . Science has been used multiple times in the hearing. In medicine, we have a fair scientific process of vetting and that is peerreviewed blication. What i am holding is a publication of a treatment algorithm that was vetted by a journal listed in the library of medicine and the first was the american journal of medicine, the updated version will appear so this is the best available science and as a doctor it is there publication record and in this hearing i hope the senior publication record. The minority witness has never published on the treatmentt home. There is evidence to support each andvery one of these components and i would say because you look like you are older an may be a patient of the practic and cardiologist i can tell you that its likely in addition to what he mentioned you would get tohe second or third level of the protocol which would involve the use of steroids as well as blood thinners. So, for my patients that have heart or lung disease, Kidney Disease, who are ill typically in their 70s and 80s its going to involve the prescription drugs that have support for the Scientific Evidence. And this is a call not just for a small group of innovative doctors and researchers t broad medical community. We have a million doctors and have a million Nurse Practitioners on the sidelines right now. Th are saying we dont know what to do the governmt is telling us to do nothing. We are building up in the United States. I do not hear a sense of urgency at all. We are weeks away from panic a massive mortality. People talk about thanksgiving dinner. There are so many infected peop now the labs are hitting 20 positive. That meanshe number of people coming to the lab that are testing positive is 20 and the average person infects many more people. This is a massive calamity that is right around the cner and im asking and pleading for the senate in between administrations which is a very vulnerable time to not absolutely get clobbered with a tsunami of mortality particularly for the elder citizens. I know ive run over but i think im the last person so id like to ask a question. I will give another minute here. Are there any of these kind of studies about the effect of blood thinners if people are on already or they have less incidence of having covid . Thats an interesting question. I am not familiar with studies of existing patients. I have seen one hospitalbased study of the difference in the benefit between regular and another drug and it showed a two thirds reduction so its promising to look at. I dont know whher it would be useful in the regular use of outpatients. The mechanism is complicated and we are not really on top of it so we try a number of different medications. I can follow up on that and enter into the record 3625 patients who were treated with novel anticoagulant drugs it was a 50 relative risk reduction. So, blood thinners in highrisk patientand high riskpatients ind on this there is a stratification we can identify who is more likely to need these and they are older patients with heart and lung disease and theres a dramatic benefit so early sequence therapy isnt all about hydroxychloroquine or about the virus. Its handling the complications the virus creates. In our protocol we start the patient on aspirin at the beginning 325 milligrams every day and thats found to be very helpful for the prevention of the coagulation problem. Thank you all. You know as ive spoken in the conference ive been pushing Early Intervention treatment. Whatever works because to me that was always going to be the key component of ending this crisis and we have ignored it and its baffled me and i will point out again may be part of the reason is the hydroxychloroquine cocktail is about 20. Showing more than 50 and we will talk about that a littleit later inerms of the side effects of that in the studies and the sciee behind it it costs over 3,000. Could that be one othe reasons why the effort is put on these more exotic therapeutics tha costhousands of dollars versus something offtheshelf that costs 20, something to consider. Thank you, mr. Chair man. And i want to thank all of the physicians here. I know that the dedication and commitment to the patients and the recovery i can hear it, i can feel it and we are happy but one of the things i would like to bring out and i think that is the key to the possible early treatment is that global testing so i want to talk about the athome testing option because this could be a critical component before we have more difficult symptoms. So, is there an even for highly contagious disease and we need to do more at a federal level for testing, prevention and the treatment option. Some things we can deliver at home if your symptoms begin to get more difficult or if you have another underlining comorbidity that may contribute. So could you please speak to how widely available the rapid athome test might change the way people access tests and change the way doctors can do Early Intervention depending on whether you have cardiac issues or other issues. They had a prescription athome test and saliva tests people might be able to get themselves to help us get treatment. Thank you for that important question. There are many things we could have done to change the trajectory and one of them certainly would have been if we could have made widespread testing available. If those were available it would have allowed people to stop quarantine so they wouldnt be infecting others and it would allow people to seek therapy. One of the key points of this hearing is about early treatment thats only possible if you get an early diagnosis and the testing infrastructure is no longer managing to be able to provide that. Im hardened by the fda. Its the first true home test and its going to be months before it is widely available and its going to be a sort of prescription only. What many of us have been calling for is the Technology Emerging and available for the widespread availability of home tests that would make it tremendous and would be much cheaper. I beeve we have the technology to do it and thats going to be a critical part of controlling the pandemic. May be in one of the packages because i do thinkhat that would help us. Another tool in the toolbox and another thing iant to talk about is the treatment takes healthcare workers across the medical sctrum to administer the test, analyze it. I want to talk about the health re capacity, the role of the cagivers in this mix. I know i have a lot of bipartisan bills that provide tax credits, trainin and support. A caregiver and others that ultimately support increasing the medical infrastructure so of course allf this marginal is him in the toolbox many people would see the Healthcare System nd of buckling under. So what kd of investments uld you hope that we might put forward in the futur package for training across the medicals spectrum for the treatment and services. So if you could address that i think that is also key. We think about it as hospitals and doctors offices and pharmacies, but what it really is is nurses and doctors and pharmacists that work in these places and in fact one of the things i have been worried about is we are not paying enough attention to the Healthcare Workforce right now. When we think about the Hospital Capacity in the middle of the search, we often say that hospital has plenty of beds. They are not going to do anybody any good if there isnt a physician to take care of the patients we havent been paying enough attention so that is absolutely critical in finding ways of supporting them obviously a critical thing is we need to make sure they are protected but theres more things we could be doing. Then when i think about the distribution challenges, we talked about the incredible vaccines that are coming and the importance of getting them out quickly. We will want to vaccinate hundreds of millions over the next six months. They will have to be done in all sorts of places including in the pharmacies and doctors offices, hospitals. We have to find ways of training and supporting these workers who can actually deliver these kind of services. So, in any package that supports the Healthcare System, thinking about the healthcare workers first and making sure they are getting what they need is central. I can see that i have st about a minute lefand im trying to think about the support systems for the treatment and vaccines or whatever that is. I also think about in the communities across the country families are struggling economically and in those other kind of existential things milies need in order to stay healthy and get to doctor, we have our food banks in the united way and across the untry doing that. So, can you talk abou some of the things people should be able too we talked about whether it is vitamin supplemen or other things people might take. They are notven able to purchase those if they do not have a job and that contributes to the bad health outcomes. A critical partf this response is getting people through this time period. We have seen very long lines and food banksnd people goi to work i dangerous situations because they do not have a choice tyve got to put food on the table. In the middle of the bgest Public Health crisis in the country, i think all of us agree helping people through ts time period, we are not talking about forever or talking about years. We are talking about the next three to six months as a critical period making sure people have enough food and have access to healthcare. Ose are central because if people dont, people a going to make tough choices thawill make the whole pandemic worse. Any pretense of strategy on the pandemic preparedness and response needs to choose exactly the ones you have laid out. Thank you. I appreciate that. Ive gone over my time. There are other things that will help us succeed to look at whatever we are prepared to help everyone get tm andet through this pandemic in the country. Thank you. Tnk you, senator. I have a number of questions i will ctinue to ask. The point about testing evybody agrees it would have beenreat to have ndreds of millions but it isnt practical. It didntappen. This is an track where you just say computer, 300 million tests. Using offtheshelf drugs f earltreatment but somehow because President Trump allowed the word hydroxychloroquine to flow out of his mouth all of a sudden that w attacked and poisoned and we never, ever had the nih, cdc, fda put their weight behind an investigation of that. I s pushing for that, pushing for the science, for studies but it never happened because again, it was censored and wealk about the disinformation not oviding the Public Information is disinformation as well. So aga, what i fault the agenes is because they turn a blind eyeo simple, cheap, possib effective treatments that by the way created no har ive got a lot to go over here. In t nonrandomized trials i guess we call that observational studies, realworld experience. Really involving thousands of patients indicating that there was a 50 reduction in the hospitalization deaths. In the saudi arabia study, five times reduction lets just assume that that is true. We could also take a look at the billions of doses each year that arprescribed with hydroxychloroquine. Any member of congress has just been handed hroxychloroquine. We treatupus and Rheumatoid Arthritis. The studies i saw early on were designed to fail in treatme when their heart was aeady affected by the virus of cour hydroxychloroquine does have an impact on that late stage. But not early. It was being rommended for early use the first five days. So, when you take a look at the risk reward now that theres these other observational nonranmized trials were studies conducted, 50 o five fold reduction. This has made no sense to me whsoever. It is the politicization of it which i made in the opening, and saying that has been such a shame. I do want to, bore i forget, i received a letternd an article from the enomic standard submitted by docr stephen hatfield. The letter kin of expins. To work on establishing t expanded access investigational new drug protocol but by his insubordination, he instead went to janet and people in the fda and got the emergency use authorization that sounds like we are goi to expand the use of this. He dramatically restricted the use only in the hospital but i think well recognize it is probably not particularly effective and possibl dangerous and only on the national stockpile. He knew what he was doing. That is what poisoned t well and created the prescription. And in the trement options they took him off the table, we took our eye off the ball thats why i s our agencies failed us. These individual agencies failed us and you mentioned the circle of empathy. You just talk about how you prescribed that. Let me say before i answer that this is n just a government culpability and malfeasance with spect to hydroxychloroquine. This is academic and malfeasance. There were fraudulent papers one published by individuals interested in doing evil to the world with respect to a beneficial treatment in an unprecedented manner these manuscripts were withdrawn after two weeks where they could scare the public and the worlds audience. Since that time thereve been dozens of im sorry, they were then withdrawn . It acknowledged that they were fraudulent papers. They were to scare people in hydroxychloroquine. Since that time theres been dozens of play along scare tactics. This is people in my field, academic medicine who are committing academic fraud. I am a cardiologist and reviewed a paper that made it into the literature demonstrating that it causes a heart attack. It causes a giant scar on the heart and i can tell you we have the worlds most recognized Cardiology Program in the world. Our senior examiner has held more human hearts than anybody in the history of mankind. I can tell you firsthand it doesnt cause giant scars on the heart so academic medicine is committing fraud and crime against humanity. There must be a motivation behind this that is bigger than democrat versus republican. Im extremely concerned honestly about the academic contribution. India is such a crowded country. Ive been there myself. The deaths per is it 95 over and they are using hydroxychloroquine . While it is spread out in india they are on top of each other and less than 100 million per population. The leading doctor in india is willing to come testify to the United States and to tell you the reason why they have tons of covid spreading like crazy. Its probably about four or so plus the supplements and theyve handled the infection. It isnt a third world country. First line youre given hydroxychloroquine. Theres 30 countries that have approved the version including japan. Every country that is actually having a reasonable Public Health response is treating this problem at home. They allow the patient to get through the illness like myself i missed ten days off of work and returned to the workforce. I didnt get in the hospital for four weeks. They allowed people to stayathome and not go out and contaminate other people. We were actually able to stay at home so we didnt contaminate other people. The Current Program that supported by the minority witness and institutes of health and our government bodies is patients go home and get no help whatsoever, doctors are not supposed to treat them, they go out in a panic and contaminate more people and then they are hospitalized and die. America has to wake up right here right now. We are getting buried and we need home treatment. Let me have you jump in here. We have got the vice chair of medicine and i believe harvard trained, doctor harvey completely different assessment of literatures and study versus what you are talking about you use to say with a great deal of authority. Do you what is your opinion of these is a pejorative to you gentlemen, do you think they are just idiots . You are very authoritative and refuting what these gentlemen are talking about. The disconnect, this is what America Needs to evaluate. So tell me your opinion of these gentlemen. Senator johnson, i dont know these gentlemen. They are all clearly qualified and smart, and i believe they are all clearly committed to the right issues. I have no reason to doubt any of that. My problem isnt that we have a different reading of the literature but its the idea that there is a broad conspiracy across hundreds of thousands of doctors at the nih, the cdc, all academic institutions and Infectious Diseases society of america were all in on this conspiracy to prevent americans from getting a lifesaving therapy. As you might imagine, pulling off a conspiracy like that would be extremely difficult. Doctors and academics are way too disorganized to pull off such a thing. By the way i never used the word conspiracy. I dont think anybody quit using that word. Something happened where we havent devoted any time or energy or resources to doing what could have stopped this crisis very quickly. And that is called Early Intervention and early treatment. I agree and i will not use the word conspiracy and i apologize if that was at all offensive. I didnt mean it to be. The point is, we have tried. There are ongoing randomized trials with outpatient therapies. And what i have said literally from march when this issue first came up, and i have a long track record, is i hope this works. I pray this works. If it works it is going to make a massive difference. The literature on this is not like no one has studied it. Weve had multiple randomized trials including some in the setting. They jt havent worke. s. So you use a scare tactic with hydroxychloroquine is an infinitesimal impact butith this information in terms of yo communication. It like a chance to reond first of all i never said the problem with hydroxychloroquine. You made the claim itas unsafe. Let me finish that thought. I didnt mention the 93 percent i could mention the fact there is more than 76000 incidents of toxicity reports during the middle the pandemic t the bottom line is every drug has some safety isss including hydroxychloroquine. That is not the most compelng issue that i did so i think we should focus excessively on that what the future data shows that it does will be the first to promoted but i have to be driven by data and science. There is a real dispute. I understand i selected three and they selected you, but there is a dispute im not one does this theres only not the three people of the risk reward ratio. The risk reward issue in person or peters back on screen but i think me as an american citizen with the freedom with the bill that i hope to pass should have the right to access this without the interference of bureaucrats and the cdc and the fda. That is exactly what has happened. I cant get it millions of americans cannot access it because of the misinformation and scaremongering and the logjam created by bureaucrats. So you sit back and say it hasnt been proven effective but yet they never push the trials to analyze it. Now you can sit there with all of the authoritative but we have some gentlemen here that are treating patients that completely disagree i will turn over to senator peters. Would you like to respond . I do you could say i disagree that we have disagreement but the way i tend to adjudicate these things i will ad the literature and form an opinion. So apossible anyone of us could be wrong but at that point we look to consensus opinion among expertwith Infectious Disease issues because the leading Infectious Disease experts they do not recommend the use of hydroxychloroquine for covid19 and recommend against it for inpatient i will tu to agencies like the National Institut of health and listen to people likeoctor francis collins. The point is that these are all individuals with incredible expertise looking at the data could it be that the doctor is right . Yes people disagree but look at the broad consensus in the Scientific Community it is very clear that hydroxychloroquine is not effective but those that it doesnt work and we get better data . I would love it if you would push for better quality randomized. I have an they wouldnt do it. I cannot get them to do it which again why not . This is an enormous dereliction you can turn to those different places but as a patient and wanted to get hydroxychloroquine and i could not get it. I should have the right to try and dealing with my doctor who i trust im sorry some of these are outside the circle of empathy and for whatever reaso reason, im sorry its just me a question the fact because the cocktail cost about 20 and the other cost 3000 and there is a little bias or conflict or agenda else i treating a patient you are dealing with sick and dying and ventilated patients so with the three of you here, talk about the study and how strong of a science that is what dangerous side effects. That is the drug that has been pushed with emergency use authorization. I would just make a few comments to just say that anyone of these randomized trials in my view, in my judgment of the evidence they are all inconclusive patient studies do you know t endpoint . To decide how much oxygen the patient needs and then they change on the ordinal scale the entire randomized complex right now is corrupt so that data is mixed i just had a patient died this week the cute difficulty is its too toxic he had liver toxicity when the drug is administered too late by the time he got him to the hospital the virus has already done its job. So to test a single drug late in the illness its no different than hiv and the best we have right now is a mix of Vitamin Supplements now the nih with pharmaceutical trials if it can fit into a treatment protocol is ready to go nih and biopharmaceuticals have delivered zero oral medications. Zero. Thats a batting average right now so as the country. Isnt it also true in the study very late in the trial because we are showing no improvement in reducing death but they actually switched. There are so many flaws to the Clinical Trial people are looking to one that we never change the primary endpoint and to have the objective endpoint thats determined social delays and Everything Else. So none of the trials if he was to use the word evidence evidence evidence. We a in a crisis we need the art and science of make it one medicine that using the sequence multi drug approach it doesnt prevent hospitalization. One is the workforce issue to say hospitals are not overwhelmed based on the uptick of the surge of kates is but they dont have the workforce which again speaks to if we focused on early treatment you can have a more ready workforce but a of nurses and doctors to stay home because schools are closing they have to take care of their kids from my standpoint we have not done a very good job of addressing this in a logical way. We are missing the key ingredient to solving this crisis which is only effective treatment. So what have the studies because we scare them away from participating in the trials in the us to do a study and the difference between the random control trial. Mentees hydroxychloroquine very effectively. Those that cherry picked emselves and all those who are not doing well didnt report and didot tell me so i said to two of them keep doing what youre doing will follow up with you in a month or s weeks and see what you have done after that so heo longer cherry pick we study them as ndidates for their treatment plan after six weeks i went back what i foun the doctor who treated another 400 patits with no deaths another 400 high risk patients and sincehe first time that i talk to him and no death and at that ti doctor. Had 180 patients subsequent when i talk to him and he had on deathhe real world evidence is such no rational person would say would go to them they would be the first person i would go to because they would prove they could do is it is working and they are saving patients. You said theres one death thats from covid not hydroxychloroquines work it was a death from covid the person has a heart attack out of the blue unrelated and two weeks past and finish the treatment so he wasnt sure if it was related to covid so its not even clear. Thats the first thing. The second part of the real world evidence a non randomized trial the real benefit is if there are the unknown variables and that what you can adjust for in your study and remove them seem to have a pure treatment between the people who take the drug in the people who dont only the unknown variables they have converged we have learned enough about the diseases that we study we know what else to measure and we control for them that is the unknown bias and thats why theres a difference in non randomized trials and how to control for it. Thats the second issue but well controlled trials work just as well as randomized ones. Should we mention the doctors data fully under the process spirit the practice of medicine we all agree and then you do it that every person is the same and we all act on react to those protocols. And particularly in the epidemicnd how medicine h advanced based on just doctors being doctors and practing medicinehere world war ii was penicillin and the cholesterolowering drugs and how those doctors using their training seeing a drug that can do something for improd use over here just might work over here or have a patient with a protocol is a working i have to try something so just talk about as a practicing physician how you approach those situations. It is so important when you are on the front line we were at war in this pandemic and my colleague and i took an aggressive approach and then to honor those principles 50 years ago and i wonder if the doctor actually treats patients the way that he talks but the issue i have found to be important in all my years of practice is to be adaptable to bring in recommended from other people and examples to be more effective but then we found our treatment and we adapted it when im in the hospital i immediately put them on when one on the medication if it is pneumonia i will prescribe a cocktail in the hospital than the patients walkout and forties. So its important to be respectful of the options that may be there or not in the approach. Do you treat patients . I he for the last 20 years in the v. A Healthcare System recently switched from the boston v. A. But as a practicing physician every patient is different. But im always guided by the science serverhink of the off label use is one that i have seen more harm than good so as a practicing physician my oath is to do no harm. I am driven by that im not saying all three of these strike me as smart and committed in caring so obviously im not perfect but i y to science as well as compassion to guide me. To be treated any Covid Patients . I have not. Dr. Fareed i am aware. Evidently thats the case and it so tragic and inappropriate because he is a highcaliber esteemed doctor with tropical medicine and Infectious Disease and his dedication to his patients is impeccable. He guided me. I can only credit him for leading me in the right direction and doctor tyson in our area. So these are men that will be alkylated incredibly when this is ove now using a drug that has been around for 65 years prescribed safely without ekgs . Having close communication for the worldwide disaster with many countries, i can tell you that i did a program with the Covid Medical Network in australia to show you how offkilter the world is. In queens australia a doctor is put in jail for prescribing hydroxychloroquine. In india they give it to you right away. In greece it is in their guidelines. My point is they give the first line in their guidelines in greece in the United States we are caught up in a flurry of data and confusion. Something is going very wrong. I was contracted by a doctor who i think had written for prescriptions for hydroxychloroquine. For. She was issued a grand jury subpoena by Homeland Security investigation department. If you cant believe that. The doctor prescribing an approved drug and she gets a grand jury subpoena. Something is not right about that. Now, because i checked into it they withdrew the subpoena but something has gone wrong here something is not right. So again, all of you thank you foreing here. People have dedicated your lies one your lives. Something to be celebrated. You should be persecuted because youre trying to save lives thank you for your testimony to help people Pay Attention to this hearing. Im not pushing one drug over the other. I am pushing for robust studies and investigations into early treatment of covid to prevent hospitalizations i am for letting doctors be doctors and Practice Medicine and have the courage. And right now there is no other option. I think it is inhumane to tell somebody who is justifiably fearful i just tested positive if it drops below 94 can i try nothing . I cannot try a drug prescribed for 64 years . I cant do that in some states . I think it is unconscionable and makes no sense. The risk reward ratio is so in favor to give these things a shot. When i tested positive with one episode of a fib my cardiologist told me not to use it again with vitamin c and zinc maybe im just a lucky 40 percent but i will tell you one thing that i develop symptoms without a doctor i may have called upon of you and tried hydroxychloroquine for what i know i think the risk is so low even though with a fib i wouldve tried it because i dont want to go to the hospital. I think most americans if they think rational will want some type of treatment. So with that thank you for being doctors and putting yourself on the line because you are criticized and i will be criticized we will be censored will be raked over the coals describing is what you did as a trial was pulled off of youtube and we hope to get back on youtube. There is something going on her here. The American Public listens. And i hope we and up developing early treatment for covid to get this behind us we are sick of it. Therapies and we want the vaccine that we cannot wait for the vaccine. Thank you all. The hearing will remain open for 15 days for the submission of statements for the record. We are adjourned. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] weekend on cspan 3. Every women lawmakers talked about politics and gender equity issues. The conversation was hosted by the hill. Hello and welcome. Im steve comments, editor of the hill. Thanks for joining us to