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

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, remdesivir, 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 aorta 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 fulker 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 safe and effective and are trusted by the American People. Unfortunately, this demonstration has continued to exert pressure on our governments top Public Health agencies to water down 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 the very start of the pandemic the president and others in the administration have consistently undermined and questioned Public Health experts at the food and Drug Administration and the centers for Disease Control and prevention. They have pushed unproven treatments instead of leading by example and practicing simple measures that we know prevents the spread of virus like wearing a mask and social distancing. We made some of in the news in the covid and they must be free from politics and driven by solid data. Recent promising news from both pfizer and madonna indicate that there vaccines could be highly effective and however we are still waiting for further review of this data and even an authorized or approved vaccine will not likely be widely available for many more months. We must continue to use masks social distancing contact raising and other measures for the foreseeable future to protect our friends and our neighbors and to stop the spread and ultimately, to save lives. Thank you, mr. Chairman. Thank you, senator peters. It is the tradition of the committee 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 and nothing but the truth, so help you god. Please be seated. Our first witness is doctor Peter Mcauliffe 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 two week 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 innovator. 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 american doctors who have innovated and faced this problem. I can tell you that they are achieving rates of hospitalizations and deaths us than 3 for high risk americans and over 50 with conditions and most doctors can achieve less than 1 . With no treatment in the United States are now individual over 50 with medical problems faces 7 rate of hospitalization and death. Someone in the 80s that skyrockets to 40 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 hydroxychloroquine, if i had to say [inaudible] and i compare with other drugs and then steroids and that should be nine controversial but doctors should be using corticosteroids and sword fed as well as blood thinners. What doctor would not help a patient who is at risk for a catastrophic stroke that occurs as a competition of this 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 organize all Government Agencies that are related to this to assist doctors rapidly with their innovation and their Compassionate Care of patients with covid19 at home because we can present hospitalizations and death and right now is the only on the table. Thank you, doctor mcauliffe our next witness is doctor harvey risch and doctor risch is a professor of epidemiology at the Public Health and Public Health yale school of Public Health and the yale school of medicine. Doctor risch received his md from the diversity of california san diego and phd in bio mathematics from the university of chicago. Authored more than threaded tourney five original Research Publications and member of the Connecticut Academy and sciences and engineering and he research the efficacy of the seven outpatient medications for the treatment of high risk of a 1942 hospitals across brazil. Doctor risch. Thank you for convening this hearing. We all understand the endemic disease we are facing and that we have to face headon and not hide from it hoping that it will go away so i will give you my perspective on this. In may of this year, i observed the results of studies of a drug suggested to treat covid, hydroxychloroquine, were being misrepresented but what i thought at the time was sloppy reporting. We heard from doctor mccullough how covid disease progresses in phases from viral replication to pneumonia to multiorgan attack. Viral replication is an outpatient condition, but the pneumonia that fills the lungs with immune system debris and is lifethreatening is hospitalizable. Weve also heard how each phase, each pathologic expert of the disease has to have its own specific treatment and how those treatments are derived from the biologic mechanisms of the disease and thus i was frankly astounded that the studies of hospital treatments were being represented as applied to outpatients and in violation of what i had learned on how to treat patients in medical school. We are now finally coming to address why over the last six months our Government Research institutions have invested billions of dollars in expenses, patent medications and Vaccine Development, but almost nothing in outpatient, early outpatient treatments, the first line of response to the pandemic. Its not that weve lacked candidate medications, we have had a number of promising agents, but i think the early conflation of hospital with outpatient disease served to imply the treatment of outpatient disease has been studied and found ineffective. This illogical premise motivated me to look at what the evidence for outpatient disease and treatment were. So i want to reiterate that we are considering the evidence for early treatment of high risk outpatients to prevent hospitalizations and mortality. And thats 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 actually 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 accompanying agents, has shown substantial benefit in reducing risks of hospitalizations and mortality. Now, these studies break down into two major types. The first is the double blinded randomized controlled trials 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 in widespread use before randomized trials were ever done , the mostomycin common antibiotic used in children, was not established by randomized controlled trials. The great majority of drugs that it are in use today were not established when they went into widespread use for the randomized trial and many had randomized trials later but this establishment 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 the doctor may later tell you it is what many doctors believe, but this idea does not stand up to the body of medical studies and data that addresses it. In fact, we have large amounts of Empirical Data looking at the difference between nonrandomized and randomized trials. Frieden, previously the director of the centers for wrotee control in 2017, an extensive essay in the new england journal of medicine showing that nonrandomized trials and randomized trials provide equivalent compelling evidence, equivalent evidence for the efficacy of treatments. Could you please enter the article into the record . Underlying this was a gigantic metaanalysesof 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 gift the investigators examined what involves tens of thousands of study comparisons which is a gigantic amount of data, between randomized trials and the 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. Why, wellnce is performed nonrandomized trials are every bit as much of a Gold Standard today is the randomized trials you have 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 it is given to adults and children, pregnant women, nursing mothers, and such a drug must be safe and it must be safe when used in the initial viral replication phase of this illness. Which is, in fact, in outpatients initially similar to a cold or flu. And so, could you please put the the oxford paper and its supplement into the evidence, into the record . This is a paper showing more than 900,000 hydroxychloroquine users that show no excess mortality and no increase cardiac arrhythmia and also please put into record might my article from the american journal of epidemiology. Despite of the safety, 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 events in out pages outpatients 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 in high risk outpatients, and everyone of these studies has shown significant benefits. This includes 636 outpatient in brazil, 119 clinic patients in france, 717 patients in a large hmo network in brazil and 226 personal patients in france and more than 1200 in new jersey longterm care institutions in , 100 andorra and almost a almost thousand patients eight 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 were stopped early, but together, when analyzed together, as we did, they show statistically significant reduction in risk and that is what matters. So that is the paper, if that could be also entered into the record. This body of evidence for hydroxychloroquine dramatically outweighs the riskbenefit ratio for remedisvir and antibodies , the fdahe difficulty 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 hydroxychloroquine has shown benefits and there are no studies as far as i know of last night that are high risk 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 expensive new treatments, which have yet to be proven, while there has been almost 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 and early outpatient treatment is still and will be continuing an essential part of ending this pandemic. Thank. Thank you, doctor. Our next witness is doctor george fareed. He is a Family Medicine specialist in california with over 50 Years Experience in the medical field. He graduated with honors from Harvard Medical School in 1970 and thats two decades of teaching and researching academia. He returned to clinical medicine established at general practice and 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 countless covid19 patients, outpatient and inpatient patients. Thank you. Mr. Chairman, senators, and colleagues, thank you for is your microphone on . I hope so. Can you hear me . Try to bring it closer. By the way, all of you have longer testimony, that will be entered into the record. Again, thank you, mr. Chairman, senators and colleagues, thank you for convening this hearing. I have a background in virology, and Academic Research work at the and i 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 and being a hospitalist. My experiences during the pandemic treating Covid Patients 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 cytokine 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 clinic and dr. Brian tysons all valley urgent care clinic, where i also work, over 25,000 fearful people were over twoover and thousand 400 were 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 based it upon the great work from the doctors, they are our heroes. It was a triple hydroxychloroquine cocktail, hc q3200 milligrams over five days , azithromycin, doxycycline and zinc, which is often left out in the studies. The cocktail was best given early as doctor mccullough has indicated within the first 57 days, where the patient is in the flu stage and the timing of the drug is when the virus is in a very active maximal replication phase in the upper respiratory tract and our goal has been and still is to prevent it from entering the lower risk the lower respiratory tract and present hospitalizations and we achieved this in over 1000 patients. And that was involved, reevaluated at the 23 day intervals. We blending corticosteroids and keep on the treatment if symptoms warrant but generally did not and do not. We use it especially in the highrisk individuals and those over 5060 and those with core comorbidities or anyone with moderate to severe flu symptoms. We want to avoid the long covid syndrome and all patients that happens after they recover. The healthy dont need the treatment. I use this regimen to treat 31 elderly nursing home residents in an outbreak in june and 29 recovered fully and the drug works mechanistically through coup actions, hc ache cq hc q through the gun and zinc and it blocks the signal one receptor and a several others antiviral thefts and the antibiotic has an antiviral agents. As anticovid agents become available they can be added to this regimen to enhance its efficacy and we are routinely now combining i vermette been now combining in a cocktail with excellent results. It is safe and has a different anticovid action. This becomes analogous to the use of multiple agents for hiv treatment and antibodies from regeneron and eli lilly will be suitable when readily available. The results are often dramatic with improvement within 48 hours. We would not have stayed with this if it werent helping people, and always reliable, and we have seen very few hospitalizations, not 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 the stages of covid. The science, why early treatment works. Early treatment, it has led us to actually try to communicate our approach. We think it should be on a National Level and we wrote a to thewith my colleagues president , a letter to congressman, 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 if highrisk individuals get sick but there is a solution for them with early treatment, with the antiviral cocktail. If early treatment becomes widely available, people will be much more confident going back to work and sending their kids back to school. Thank you. Thank you, doctor fareed. Our final witness is another doctor. He is the dean of the Brown University school of Public Health, a practicing physician and Health Policy researcher. He received his md from Harvard Medical School and 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 pandemic preparedness response and has led groundbreaking research regarding the Ebola Response and now on the frontline covid 19 response effort. His research focuses on include improving the quality and cost of Healthcare Systems with a specialization of the impact of Public Policy on these systems. He currently practices as a general internist at preventive administration Medical Center in providence, rhode island. Good morning, chairman johnson. Sorry i cannot be there with you in person today but it is my honor to be a part of this hearing. As you have heard we are entering the most difficult days of this pandemic and so i am so pleased that the committee has met to discuss the value of outpatient therapy. Treatments that can be given early in the disease course and by treating people early we can prevent hospitalizations and save lives. The good news is that there are outpatient therapies being evaluated and we should be hopeful and i am hopeful that some of them will work. One area where outpatient therapy has largely not been used is useful is hydroxychloroquine. Earlier in the year the fda issued a surprisingly early surprising emergency youths authorization for this message this medicine and a subsequent data came in it was revoked because it became clear that hydroxychloroquine was unlikely to be effective for covid19. Was the fda justified in issuing an emergency youths use authorization in march . I believe it was not. The eu as are contingent on three interrelated questions. First, sufficient data to even make adjustments to have enough evidence and second, 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. For hydroxychloroquine there was not sufficient evidence and the evidence that was there certainly did not suggest benefits would outweigh the risks. The basis for the hydroxychloroquine eua was from Laboratory Studies and really ultimately one small non randomized, non blinded study of hospitalized patients in france, findings that were later discredited and the scientist who led the work is now facing disciplinary actions. Since then dozens of studies have examined the efficacy of hydroxychloroquine and here is the bottom line. Every single highquality study has failed to find any benefit of hydroxychloroquine for covid19. I have to say im disappointed. Hydroxychloroquine is a cheap and widely available medicine and if it was effective it would have made an enormous difference. Unfortunately it isnt effective. There is now clear consensus in the medical and Scientific Committee based on overwhelming evidence that hydroxychloroquine provides no benefit in treating covid19. This includes in the outpatient setting. So lets talk evidence. A large randomized controlled trial published in the new england journal of medicine found no benefit of hydroxychloroquine given to outpatients with you were exposed to sars covid. But recovery trials found higher rates of death among hospitalized patients for hydroxychloroquine but this included people who symptoms have begun within the past seven days. That early phase of the disease that the doctor talked about. Other inpatient files found trials found similar results. There are outpatient highquality randomized doubleblind studies and they have also failed to find. Doctor risch talked about observational studies we should talk about that. Can they be helpful . The answer is they can. We dont generally use them for treatments because we want highquality data but it is possible to use highquality observational studies. Highquality observational studies require controlled groups that are comparable and use sophisticated statistical techniques and look for things like natural experiments to help us understand whether something is likely to be useful. Im not aware of any observational study of hydroxychloroquine that is a particularly high quality and for every poorly done observational study that shows benefit we can find poorly done observational studies that show harm. The way out of the lowquality evidence quagmire is to generate Higher Quality data. It turns out history of medicine is replete with treatments that we all thought worked, but turned out not to. Anecdotal evidence, it turns out, isnt actually evidence. The miracles of american medicine have come from applying rigorous scientific standards to timedeas and each hydroxychloroquine has been subjected to such a test, it has failed. 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 . The fda issued this eua for hydroxychloroquine in march of this year and in april it was there was a 93 increase in related calls to the u. S. Poison control centers. These things can hurt. Finally, a word about the eua process. When the fda scientists are left alone to examine the science and data, the process largely works. They understand the urgency of the moment and the need for faster approvals. But authorizing therapies due to 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 it is a potential therapy. We should study it and if it works, we should use it and if it doesnt, we shouldnt. Givenhave to be honest, 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 with so much suffering and death, we should focus our efforts on promising approaches to help americans get through the crisis. Thank you, dr. As i said in my Opening Statement i figured this would not necessarily be as broad a discussion based on other early treatments. Dispute oninto the hydroxychloroquine. We have a disconnect between testimony, between experts. Harvard and dl educated doctors and phds. Dr. Mccullough, the 93 increase in poison reportings sounds pretty scary. You mentioned before the hearing a bit about what that is based on. Can you talk about that . Also, i guess you have had covid. You recovered from it. Not totally, you have tested negative so you dont represent a danger but can you first of all talk about the 93 increase in safety, or in poison reportings, then also talk about your own personal experience with your own treatment . Senator, i want my testimony to clearly be on the record that dr. sk the previous testimony is reckless and dangerous for the nation. His comment about poison control is what dr. Peters is interested in. You are interested in misinformation regarding covid. In the middle of the pandemic, when hydroxychloroquine was appropriately used, the first wave of the pandemic, that is what kept it from skyrocketing. Hydroxychloroquine was widely used early on. That is what kept the march, april, may curve down. When it was used, and we had 500,000 dose administrations of hydroxychloroquine. The Poison Control Center received, i think it was 77 additional calls. ,hen the reviewer looked at it two thirds of them, somebody took an extra dose and they were concerned. It boiled down to 17 cases out of over 500,000 administrations yet the doctor holds that up to the American Public as a scare point to scare the public away from a safe and effective therapy for covid19. I had it myself. I am 57, i have asthma and at the scrod of cardiovascular disease. I can tell you senator, i was note for leslie reassured falsely reassured setting at home. I was terrified. Every older patient with heart and lung disease when they get the report, they are not falsely reassured them thinking this is going to be a picnic. They are scared to death. By the time by the time they come to the hospital, they know they will be isolated and wont either family movers again. I did the right thing. Agot myself rapidly into treatment protocol through a study, hard to do by the way, because the government offers no resources to the public to quickly get into Clinical Trials. I got into a Clinical Trial, took hydroxychloroquine as part of your multidrug sequence program which is in the peerreviewed literature which is the framework of how americans should be treated. I was a few days behind recognizing what was going on. The virus got into my lungs. I got anxious. I got to the point where i thought maybe i could be hospitalized. I can tell you firsthand, this cocktail of drugs works for sure but hydroxychloroquine dose by dose settles down the fever, settles down, reduces the severity and intensity of symptoms and by that mechanism that is the reason wife hydroxychloroquine reduces hospitalizations and deaths. When patients get anxious and cant breathe they go to the hospital. This isnt complicated. There are over 100 studies, they are all supportive. The eua says when the preponderance of evidence shows the drug works we ought to go. My view is we need to go with this on everybody highrisk in america. When you listened to the doctor he sounds authoritative. Do you have a response . Yes, thank you. Thank you. I think that what i said early on about the conflation of hospital with outpatient studies is apparent that there has been lots of studies and there is no doubt that there are plenty of hospital studies, and some of those hospital studies in deed shown no benefit, if not harm. There are reasons for that and i dont want to get into the technical issues of the studies but just to say its irrelevant. Studies 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 jha says they are not highquality studies but in fact, they are highquality studies and they are controlled studies and were tantamount to randomized except the patients chose whether to take the medications or not while consulting with their doctors. You may say could that lead to biases . The answer is yes but the bias is that when patients are sick, they are more likely to take the medication they are offered and not quite as sick but they know they 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 medications and in spite of the builtin bias, the patients do better. Studies in brazil and other studies show that the bias is against finding a benefit of the drugs and in spite of the bias, the study showed benefit of the drugs. Furthermore, the studies all measure all of the different variables about the state of the patients, both on the conditions and chronic conditions that they have about the progression of their illness and so on that reflects how likely they are to be hospitalized or not, independent of the drug and the studies that address that by what we call statistical adjustment. The studies we are not back in 1950 doing epidemiology. We are back in 2020 doing epidemiology where we know all advanced statistics and methods 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 the Library Consortium compared in tens of thousands of studies of modern epidemiology studies compared those studies to their corresponding randomized trials and showed no difference. You cant label these studies as poor quality studies and give a blanket on that if you want to say a study in particular is study in original marseille was, that was the motivating study but not an evidential study that there is no one proclaiming these are for poor studies. They are good, modern studies. The only difference is that randomization, which we adjust for. Additional they are equivalent it is shown they are equivalent to randomized studies. I want to quickly go to the doctor. Watch the clock as you answer questions to stay in time. You believe you put your patients at risk i treating them the way you have . As a doctor who looks at patients with compassion, do you believe it would be better for you to do nothing and send your patients home with no treatment whatsoever, hopefully to survive this without having to go to the hospital . Can you comment on that . I am concerned for safety of my patients. I have not ever wanted to put any patient at risk. And i was concerned early, slightly, but not very much because of the results i researched and my colleague also, doctor tyson, had taken the same approach so the answer to your question is that i have no qualms or concern whatsoever. I am very pleased to put the patient on the protocol and to enhance it with the other agents that we can blend in, because i know they will get better. They are so appreciative. It is very gratifying, quite frankly. It is almost like, i treat hiv patients and it has been very gratifying to treat hiv patients because they can go into complete remission. When i started it was a fullblown epidemic and people were dying right and left. Now, or covid19, i am happy to get a call from kansas or somewhere else where their doctors are not providing treatment and to immediately call it in because i know its safe and it is only going to help. Thank you. Again, i believe patients, americans have the right to try these things that have already been fda approved. Senator peters. Thank you, mr. Chairman. Number of questions for doctor 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. Dr. Jha, my question is what impact does political interference have on our nations ability to effectively respond to a 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 be safeguarded from politicization under president bush and under president obama. These agencies have largely been left to do their jobs because we believe, and we know the American People benefit when the best Scientific Minds apply their expertise to the problems at hand. I believe that in each of those administrations, you could disagree with policy ideas but the fundamental underlying scientific work of those agencies was always left to them. That has been different in this administration. We have seen the cdc pressured not to speak out where the evidence has been clear and weve seen the fda being pressured around emergency use authorizations, for instance. What happened with convalescent plasma, with dr. Stephen hahn going to the white house and saying things that were clearly not accurate, and everybody in the medical community knew they were not accurate, was baffling. It was upsetting because throughout my medical career, saying Something Like this is fda approved was a Gold Standard. It meant it had been gone through with vigorous scientific review and had passed that review. Those words have become less powerful now. I believe politicization of our 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 200 50,000 americans dead and more than 11 million americans infected with this virus. Dr. Jha, last month i released a report on the development and the distribution of covid19 vaccines which found that the administration s politicization of the covid19 response you have just referred to has actually contributed to a sharp, sharp ecline in americans receptiveness to an eventual vaccine. My question to you, dr. Jha, would you agree with that conclusion and what can the federal government do to rebuild trust 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 has happened, the partnership between 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. I think what has gotten us into a bit of trouble in the past couple months is as election time was nearing, we started hearing political leaders talk about having a vaccine before the election, or pressures to get the vaccine out 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 they would authorize the vaccine and when those criteria are met, i expect the fda will authorize vaccines. Ultimately, if we want to build confidence with the American People, whether you are democrat or republican, liberal or consider or conservative, what you want to know is are , scientists getting to evaluate the data and scientific recommendations free of political pressure from either side of the aisle . And if we can let the fda do that i think it will go a long way towards Building Confidence in this vaccine. Dr. 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 i introduced the covid19 misinformation and Disinformation Task force. My question is, what impact does false and misleading information about covid19 treatments have on the American Public . Senator peters, this has been a huge challenge but we are facing the biggest global Health Public crisis of a century and it has been compounded substantially by the sheer amount of misinformation and disinformation that is out there. In order for us to have gotten through this pandemic without suffering the staggering needed was what we collective action. What we needed was people pulling in the same direction guided by science and evidence. When we have had things like politicization of mask wearing, veryow there is now compelling evidence that if people wear a mask, in the right setting it can make a very big difference. We know that social distancing can make a big difference. We know testing and tracing can work. We have seen it in the u. S. And other countries. But the misinformation makes it harder for people to know what is right and wrong, harder for people to know what the right thing to do as and that has created a problem for us as the American People to do the things that will keep our population safe. The impact is obvious. The impact is, 11 million americans infected, to the 250,000 americans dead and we are in the worst phase of the pandemic. We can get out of this. We have the capability and capacity as an American People. But the misinformation is what is killing us at this point. Issued fouras emergency use authorizations for covid19. One has since been rescinded and another has been criticized as premature due to weak data. The gao report issued earlier this week found that the fdas Decision Making process for issuing the emergency use authorizations lacked transparency. Do you believe the fdas process is working as intended and what potential reforms should we consider . So that eua mechanism is important because in an emergency, you do not need, nor do you necessarily want to wait for full approval that you might normally want to do in nonemergency circumstances. But whenever you lower the bar about evidence and use an alternative mechanism, in order to build confidence with the American People, at the end of the day it is about confidence and trust. What you need is a transparent process. What i believe we need to hear is less from political appointees and more from scientists, and what we need is clear criteria. Things and those are Guiding Principles and things we use, i have no doubt we can build back all of the confidence that has been lost in the fda, the cdc and other agencies. We have to go back to the First Principles of transparency, openness and letting the scientists do the talking and letting the scientists do the decisionmaking. Senator romney. His senator romney no longer on . Senator carper. I will just go down the list. Senator hanson. Ok. Is everybody on that call . Know,o let the witnesses langford is available . I will go to senator langford. The lankford for all witnesses, i appreciate very much your engagements and for the work on this. There are lots of questions to talk about. With every confidence that there is work being done both in the science community, and private sector and on the federal side and quite frankly quite a few states are doing what they can to help in the process. The challenge we have now is trying to be able to get all these things happening at once. It has been a remarkable year for these things to be able to move. Much 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 any virus at this point covid19, to be able to diminish its effect or its replications. Weve talked a lot about how to protect each other and wear a mask which is a good idea. Washing hands and those things. Theres a lot of Research Going on on what can be done in the hospital with blood thickening and inflammation and organs, all those things, but it is the in between. I appreciate the dialogue at this point. What i would like to talk about with the physicians that are here is, taking a normal virus, what would you recommend that individuals should take to help their bodies fight off a normal virus . Add to that, what would be in addition to in particular what we gain from this virus as well as we go through this . I dont think there has been enough research and conversation about those two aspects. I would be interested in answering those questions because i think that is a key issue, what is typical for a normal virus and what is helpful to help the body fight off a virus in your own system to fight it off. What are we finding helpful, even if it is only a little bit with this particular virus . I will let everybody take it in whatever order. Mccullough thank you for the question, senator. Let me say i think we should probably narrow the question to the serious and potential viral fatal infections, so the acute hiv which is a serious problem, three to five drugs. Hepatitis c, three drugs, four drugs. Even shingles which can be a on, tworoblem later drugs. But the principle is always early. I cannot think of a single viral infection where the best advice is to wait two weeks before we start treatment in the hospital. That is the current nih recommendation. Americans are appalled by this. We treat serious viral infections with multiple drugs upfront early. These are principles of treatment. I would like to defer to dr. Fareed on this. Dr. Fareed that is a great question. I believe it is important for people to be proactive. We have learned a lot of what is good to help protect people from covid19. Excuse me. We have recommended, 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 lyltivitamin, a particular zinc supplement, 1525 milligrams per day, vitamin d3, 20005000 units per day, and an , aioxidant like e. G. Cg supplement that helps bring zinc intercellular but it is helpful for anticancer purposes. Think, i have learned so much from the use of cocktailxychloroquine that i am convinced it is a Broad Spectrum antiviral that is so welltolerated. Were patients now that acutely ill, i treat them, they get better in 24 hours and they are covid negative so they have had some other virus, coronavirus or possibly influenza. We have learned a lot about the value of broadspectrum antivirals that is welltolerated. I am a proponent of even making it useful for influenza. By the way is it doctor jha . Jha. Is sen. Johnson do you want to chime in . Dr. Jha thank you for your question. Antivirals are tough. As opposed to the antibacterial therapy, where we have a broad set of antibiotics, antivirals take a about 15 to develop, years to develop antivirals for b and weepatitis c and do not have good ones for most outpatient viruses. If you think about the common cold which thankfully is not fatal but it can make you feel lousy for a couple of days, we do not have treatments outside of the supportive therapy of tylenol or other things that help to manage the symptoms. They are difficult to develop. I think we all agree there is no question on this panel are among the entire medical community that finding early therapies for coronavirus is absolutely critical and would make an enormous difference. I had actually been early on, hopeful that hydroxychloroquine might be one of those things that would change the course of the disease. It just hasnt panned out. There is a lot of work going on. There are lots of things being studied and we should continue to study them. When the evidence says something works we should use it, when it doesnt we shouldnt. Is helpful. One more question. There is a lot of help out there because of the vaccines that are coming. We have two vaccines on the horizon. They could be here by the end of the year with, pending fda final approval and with this process we have four more in the queue at this point and that hope is one of the misinformation pieces that is out there publicly is i be scared because this was a fast developed vaccines you should be frightened of it. I dont share that. I am pleased there has been no shortcut in the science in the process on this and it has gone through all the studies and such on it. Does anyone here have any concern on the vaccines that are coming at all, that they havent gone through the proper science . Absence of ay response means nobody has a concern. I look forward to those vaccines actually coming to market and us moving forward. Thank you for your opinions and i appreciate your insight. Sen. Johnson senator carper. Carper mr. Chairman, Ranking Member peters, and our guests, thank you for what you do. About eight months ago almost to the day, our president said these words. He said it is going to disappear one day. It is like a miracle. It will disappear. That was february 27 earlier this year. And since that time, a loss of 250,000 people in this country as of this week. Father,s mother, grandmother, grandfather, aunt, uncle, child, nephew, niece. 250,000. My colleagues have heard me say this rhetorical question, compared to what . Compared to timeline seven, south korea, 498. Compared to singapore, 28. 27. Ared to new zealand, compared to china, 4500. India 132,000. 11,000. 11,000. Mexico, 99 thousand. Add all of those numbers up, and we have actually suffered more deaths since the beginning of this year from coronavirus than all those other countries combined. Four times the number of men and women who died in the vietnam war, more than four times. And this has been all year long there has been opportunity for us to not be divided against one another. We could have 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, one hit wonder, thomas dolby, she whated me with science. If we werent blinded by science and instead, guided by science . Thing that we can agree on. We need a vaccine and we need it badly. We need a couple vaccines if possible. We need to be able to reach out to people who are afraid to take any vaccine. We need to be able to message the American People and make sure people take it. We have to make sure it is available in great quantities so almost everyone can take it. ,he second thing we need to do we have a country of 300 Million People and how do we get the vaccine administered to people . How do we make sure people get two shots. It ind keep track and do a way that increases confidence. , hearing thist today, what i think mr. Chairman and the Ranking Member, i would urge you to focus the hearing on certainlymber, january, to focus on how do we actually do this . The American People, the vaccines are going to be safe and you have to take them. The second thing, how do we figure out the Distribution Center solution to make sure we administer it quickly and effectively . I want to ask a question if i could of doctor jha. You have talked about the need for the detailed factory Vaccine Distribution campaigns and to reverse universally high levels of Vaccine Hesitancy among americans. I would like to refer to that. What steps do we need to take to ensure states have what they and in financial, logistic getnological support to vaccines to americans who want to be vaccinated . Thank you. This pandemic is going to come to an end in 2021. We will bring it under control in 2021. We will do it through highly effective vaccines, if they are widely distributed and accepted by the American People. Is savent say lives, vaccinations do. There are many steps between vaccines being available and lives being saved. Toneed to get states ready 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 what the protocols are going to be on how it will be distributed. Those are Critical Issues. Im talking to state Health Departments around the country and there is lots of confusion and lack of clarity about how this is going to work. That needs to be dealt with effectively soon. Yesterday would have been a good day, today is better. We need to get going on that. The other part that goes beyond distribution is communicating with the American People about this. Where the other panelists and i may disagree about the value of science and Scientific Evidence for hydroxychloroquine ammo we all agree, everybody agrees the scientific process around the vaccine has been done with incredible integrity. We have to communicate that to the American People. We have to bring in trusted voices, religious leaders, society leaders, political leaders to voice that information and help people understand and answer their questions about the vaccines. We do all of that, i believe americans will be open to getting vaccinated and most of them will step up to be vaccinated and that is how we will bring the pandemic under control. Populations can be skeptical [indiscernible] how should federal, state and theirgovernments include awareness and acceptance of potential vaccines . A this is a critical issue. There is a long history of distressed 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 direct sharing of information, openness and transparency, and through the engagement of trusted voices, because while the message is important, the messenger is every bit as much. That means in my mind reaching out to religious leaders in those communities working through the evidence and data with them so they are comfortable being advocates. 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, Financial Issues and getting trusted voices on our side. Thank you for convening. Thanks for [indiscernible] i would again urge us maybe through this next month to beginning a series of hearings that focus on communicating with populations that are reluctant to take the vaccine [indiscernible] we have a lot of work to do. Senator that is a lot of work to do and we need to work together. Senator, i appreciate your questioning. Im happy to hold a followup hearing and schedule it right away. But i will say that i have heard repeatedly we have to convince the American Public that the vaccines are safe. I dont recall anybody on my side of the aisle questioning the safety of the vaccine process. That seems to have been coming from elected officials on the others of the aisle in your president ial and Vice President ial candidates. If we have to repair the damage of the credibility of peoples confidence in the vaccine, it is not because of what republicans have said. Im sorry to be partisan but it is what folks on your side of the aisle said. Versus is not a democrat republican issue you have made it that. Thank you, mr. Chair, just checking my sound. Can everybody hear me . Yes, loud and clear. Thanks to our witnesses for being here area thanks to the chairman and Ranking Member peters for holding this hearing. I would like to start by expressing my deep concern over the president s decision to fire director krebs. He 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 director krebs leadership is to be commended and his firing is unwarranted and it makes our country less safe. The directors firing on the future of the organization would be a more appropriate topic of a hearing in this committee then what we are 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 2021. Covid19 infections, hospitalizations and deaths throughout the country have skyrocketed and experts agree that we had a very difficult winter ahead of us. The senate should encourage people to make evidencebased decisions about treatment and care and take precautions to keep themselves and their families safe, such as practicing social distancing and masks. I have two questions for dr. How as we learn more about covid19 is transmitted in communities across the country, it is becoming increasingly clear that small gatherings with friends and family are driving much of the spread we are currently seeing. It is understandable that people feel comfortable gathering with friends and family who they know and trust, but i am concerned that americans arent getting the information they need to fully assess risks associated with these types of gatherings. Can you talk specifically so, dr. , can you talk specifically about why it appears that these smaller types of gatherings have been subject and what steps people should be taking to reverse this trend . Thank you for that question, and this is a really troubling issue. Of course we are at more than 150,000 infections a day. And when you look at where a lot of the spread is happening, a lot of it is happening in peoples homes. The reason is what we know about this virus at this point is that spread happens when people gather indoors and are not wearing masks. That is the major risk factor for spread. Its been a long pandemic already and a lot of people are tired, and there is a sense that your home is your safe place. And i understand that sense. But when you invite friends and family, you make the assumption that they are not sick. And i understand that. The problem is that there is so much asymptomatic spread of the virus without even feeling any symptoms at all. When you bring friends over, you get together, you have a meal and share some drinks and the because thatf feels natural to us. And that has become a major source of the spread of this virus. Communicationur for really stopping the miscommunication and undermining of science, at this point the Critical Issues are about telling people where the risks are and helping people make better decisions. This is not forever. This is really for the next few months until we have a vaccine. I want to follow up on this. The risks associated with the pandemic have led millions of ricans many others are still struggling to determine whether there is a way to travel or celebrate safely. So, what advice do you have for those who remain remain uncertain about whether to travel over the thanksgiving holiday . Dr. Jha this is one i have struggled with myself. During thanksgiving we usually get together either with my inlaws are my own elderly parents. And i thought a lot about is there a way to do it safely and i have concluded i cannot figure out how to do that safely. As much as i would love to see my family for thanksgiving, i also want them around in 2021, and i believe that household gatherings with people who are not part of your nuclear family, who do not live at home with the, it is just very, very hard to do safely right now. So i have come to the unfortunate conclusion that i recommend people not do that. They can get together outdoors if that is possible, go for a walk, spend time outdoors, but indoor gatherings, the traditional thanksgiving family meal, just dont know how to do that safely this year. My family is making similar determinations. The usual group of 30 of us who gather isnt what we are going to be doing this year. Let me follow up with you, for those who will be hosting gatherings, if they do feel its necessary for some reason, what specific accommodations and modifications to their plans do you believe are essential to help mitigate the risk of transmission over the holidays . Dr. Jha there are things that can be done to lower the risk. Again, in some places in the country and may be possible to do it outside, and that would make an enormous difference. Keeping the number of people small would be helpful. Keep windows open. Have people wear masks most of the time. People sitting separately. None of this feels like a normal thanksgiving, but we are not in a normal thanksgiving. We are in the worst pandemic in a century. What we really want is our family and friends around in 2021 so we can celebrate with them once the pandemic gets under control. Thank you for that. Thank you for your work and advice. My family will be zooming while we eat, which will be our way of sharing the meal. But thank you again for all you are doing to help keep americans informed and safe, and i yield the rest of my time. Is going to begh recognized. 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 testimony to be clear. This entire hearing was about early treatment, and what those last set of exchanges showed, a complete lack of focus. It went over the vaccine and then wandered over to wearing masks, and even 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 last series of exchanges. I will just say that i think that its critically important that Accurate Information get out to the American People about what the best science tells us about avoiding getting the disease in the first place and taking precautions to keep loved ones safe. That was the purpose of my questions, and i thank you for holding this hearing. I appreciate that. What i have found though, because ive heard the term disinformation thrown around in this hearing a lot, i know often times those accusing somebody of doing something are even more guilty of doing what they are accusing others of, and i will use the disinformation as an example. I was accused repeatedly of accepting and then disseminating russian disinformation. I did no such thing. Peters didt senator it. So i get a little tired of hearing all the accusations coming from the other side. On the credibility of the vaccine, its not republicans that are questioning the validity of the science and the vaccines. Its democrats, and i need to put that on the record. Thank you, mr. Chairman. And thank you very much for holding this hearing. Its a different hearing than anything that ive seen. And critically needed. Doctor jha, i want to thank you for the positive comments and the speed of the process for a 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 nonelection year, it might be totally different. Politics has played a role in this. One of my first introductions to any kind of a pandemic was with aids. And i remember president bush shocking all of us in his state of the union speech when he said, you know what, we are going to spend 15 billion to solve the problem of aids in africa around the world. Now back then, 15 billion was a lot of money. Not anymore. But as a result, i got involved in that process and after it passed the house and the senate unanimously, unamended, they sent me to africa to see what the problem was. I got to meet with some traditional healers. Wed probably call them medicine men, the most powerful person in the tribe, because they can poison the chief and do their own autopsy. But i asked them what theyve learned about aids, and they said we know we shouldnt bleed two people with the same knife. I dont think bleeding people was an acceptable method of solving the problems of the people who were infected, but at any rate, if this had happened i n a nonelection year, think it would have been different. I appreciate you holding the hearing on what people can do when they first find out that maybe they are infected, thats always been when we tried to do something, even with critical things like cancer. Early treatment has been important. We havent had any discussions on early treatment. I appreciate all this information on early treatment. Some of it works, some of it doesnt. That is everything that we know about when you get sick, some of it works, some of it doesnt. But when people are thinking that maybe they are going to die, they would like to have some kind of a solution. They would be willing to try some things. But obviously good news doesnt sell because you wont see it anywhere. And people arent looking for next years answer, they are looking for this years answer. And yes, they are trying to figure out how they can get together for thanksgiving. My family is trying to figure that out. And i see a real state of panic, mostly because they think until the vaccine comes out, there is no answer. So thank you for answers of what can be done. , actualar as studies uses, probably a pretty good study. Dr. Fareed, can you repeat once more what this cocktail is that youve been using and what the results have been . Dr. Fareed i would be happy to. Consists of hydroxychloroquine. Its the actual algorithm now that is promulgated by the American Association of physicians and surgeons, presents the details, but our cocktail may be a little bit different, and theres flexibility. It consists of hydroxychloroquine that we found 100 effective. 3200 milligrams over a fiveday period. Then another, 5000 milligrams. And then zinc. Very high 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 . You get your doctor to prescribe it . Dr. Fareed the doctor prescribes hydroxychloroquine and theres a growing acceptance among pharmacies to dispense it. There was quite a problem early on, the stigma that was applied to it and misunderstandings. But in any case, hydroxychloroquine is a prescription agent in the United States. In other countries it is overthecounter, and there are countries now that are dispensing packets that they take home and that they provide offtheshelf to contain all of the components, including another attractive agent for anticovid purposes. But if they do not have hydroxychloroquine, they can antioxidantsonoid that help bring zinc into the cell, and that is what is an antiviral component of the treatment. One of them. It can be taken three times a day, and that is overthecounter, 500 milligrams , but its much more effective with the agent that has multiple actions as an antiviral hydroxychloroquine. Would you beough, willing to provide us with a copy of the chart . Dr. Mccullough the word science has been used multiple times in the hearing. In medicine, we have a fair scientific process of vetting, and that is called peerreviewed publication. What i am holding up is a peerreviewed publication of a treatment algorithm that was fully vetted by a journal listed in the National Library of medicine, and the first was the american journal of medicine, the updated version will appear appear in the Medical Center. So the group is the best available science, and as a tor, the accumulation of their work is a publication record ,and in this hearing i hope the senior publication record. The minority witness has never published on the treatment at home. There is evidence to support each and every one of these components. I would say in addition to dr. Fareed, because you look like you are older and may be a patient of the practice as a cardiologist, i can tell you that its likely in addition to what he mentioned you would get to the second or third level of the protocol which would involve the use of steroids as well as blood thinners. So, for my patients who have heart or lung disease, Kidney Disease, who are ill, typically in their 70s and 80s, its going to involve four prescription drugs, all of which have support for the Scientific Evidence. And this is a call not just for a small group of innovative doctors and researchers, but for the broad medical community. We have a million doctors and half a million Nurse Practitioners on the sidelines right now. Patients are calling them and they are saying we dont know what to do. The government is telling us to do nothing. We do not treat covid. We are building up to mass panic in the United States. I do not hear a sense of urgency at all. We are weeks away from mass panic and massive mortality. People are talking about thanksgiving dinner. Come on. There are so many infected people now, the labs are hitting 20 positive rates. That means the 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 corner, and im asking and pleading for the senate in america right now, in between administrations, which is a very vulnerable time, to not absolutely get clobbered with a tsunami of mortality, particularly for our elder citizens. I know ive run over, but i think im the last person, so i would like to ask dr. Risch a question. You are not the last person. I realize that but i will give another minute here. , are there any of these kind of studies about the effect of blood thinners . If people are on blood thinners already, that they have less incidence of having covid . Dr. Risch thats an interesting question. I am not familiar with studies of existing patients. I have seen one hospitalbased study of a difference in the benefit between regular and another drug, and it showed a two thirds reduction in mortality in this one study, so its promising to look at. I dont know whether it would be useful in the regular use of outpatients. The mechanism is complicated in covid, and we are not really on top of it so we try a number of different medications for anticoagulation, including aspirin. I can follow up on that and enter into the record, billett 2020, 3625 patients who were treated with novel anticoagulant drugs, there was a 50 relative Risk Reduction or mortality. So, blood thinners in highrisk patients and high risk patients in fact weve published on this there is a stratification we can identify who is more likely to need these blood thinners and they are older patients with heart and lung disease and and theres a dramatic benefit. So early sequence therapy isnt all about hydroxychloroquine or about the virus. Its handling the complications that 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 for your positive answers. Know as ive spoken in the conference, ive been pushing Early Intervention, early 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 maybe part of the reason is the hydroxychloroquine cocktail is about 20. Right . Certainly no more than 50. For remdesivir, and we will talk about that more later in terms of the side effects of that in the studies and the Science Behind it, it costs over 3000. Could that be one of the reasons why all of the effort is put on these more exotic therapeutics that cost thousands of dollars versus something offtheshelf that costs 20 . Something to consider. Thank you, mr. Chairman. And i want to thank all of the physicians here. I know that the dedication and care and commitment to your patients and the recovery, i can hear it, i can feel it, and we are happy for the robust discussion. But one of the things i would like to bring out and i think that is the key to the possible early treatment is robust testing. So i want to talk about the athome testing option, because this could be a critical component before you wait to have more difficult symptoms. As you said, covid19 is spreading rapidly. We are about to hit the holiday season. There is an even for highly contagious disease and we need to do more at a federal level for testing, prevention and the treatment option. And something we can deliver at home that perhaps you can then be on the lookout if your symptoms begin to get more difficult or if you have another underlining comorbidity that may contribute. , could you please speak to how widely available the rapid athome test might change the way people access tests and how it might change the way doctors can do Early Intervention, depending on whether you have cardiac issues or other issues, asthma, whatever that may be . They had a prescription athome test and saliva tests people might be able to get themselves to help us get treatment. . Dr. Jha thank you for that really important question. There are many things we could have really done to change the trajectory of this pandemic, and one of them certainly would have been if we could have made widespread home testing available. If those were available, it would have allowed people to stop quarantine so they wouldnt be affecting others. It would allow people to seek therapy. One of the key points of this entire hearing is about early treatment. Early treatment is only possible if you get an early diagnosis, and our testing infrastructure is no longer managing to be able to provide that. I am heartened by the fda. It is really the first true home test, and its going to be months before it is widely available and its going to be a prescription only. What many of us have been calling for his towards new technologies that are emerging and available that would offer widespread availability of home tests that would make a tremendous difference and would be much cheaper. I believe we have the technology to do it, and we need those tests. Thats going to be a critical part of controlling the pandemic. Maybe in one of the packages because i do think that that would help us. Just give us another tool in the toolbox. Another thing i want to talk about his treatment. But treatment also takes Health Care Workers across the medical spectrum. You need to administer the test, analyze the tests. So i want to talk about our health care capacity, the role of the caregivers in this mix. And so, i know i have a lot of bipartisan bills that provide tax credits, training, and support of caregivers and others that also support increasing the medical infrastructure. Extra swabs, federal funding for rural areas to improve nursing. So of course all of this in the toolbox, many people would see the Healthcare System kind of buckling under. So what kind of investments would you hope that we might put forward any future covid package to support training across the medical spectrum to deliver treatment and services. Because you cannot do it without the core, pharmacists, you name it. So if you could address that, i think that is also key. Dr. Jha absolutely. The health care system, we often think about it as hospitals and doctors offices and pharmacies, but what it really is is nurses and doctors and pharmacists that who 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. For instance, when we think about the Hospital Capacity in the middle of this surge, we often say that hospital has plenty of beds. They are not going to do anybody any good if there isnt a nurse to take care of the person in the bed. We have not been paying enough attention to Health Care Workers. So that point is absolutely critical. And we need to find 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 have all talked about the incredible vaccines that are coming and the importance of getting them out quickly. We are going to want to vaccinate hundreds of millions of americans over the next six months. They are going to 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 s of services. So, in any package that supports the Healthcare System, thinking about the healthcare workers first and then really making sure they are getting what they need is absolutely essential to such a package. Thank you. I see i have just about one minute left. I am trying to think about treatment, vaccines, whatever that is. I also think about in my community and other communities across the country, families are struggling economically. Increased food insecurity. Of those other types existential things that families need in order to stay healthy and even to get to a doctor. If they dont have health care, they have lost their job. We have our food banks in the united way across the country doing that. So, can you talk about some of the things people should be able to do in their home . We talked about maybe vitamin supplements, other things people might take . They are not even able to purchase those if they do not have a job, and may not be able to put food on the table which contributes to the bad health outcomes. That a i will say critical part of this response is getting people through this time period. We have seen very, very long lines at food banks. We have seen people going to work in dangerous situations because they do not have a choice, theyve got to put food on the table. And in the middle of the biggest Public Health crisis in the country, i think all of us agree that helping people through this 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. Those are central, because if people dont, people are going to make tough choices that will make the whole pandemic worse. And really leave everybody worse off. Onany comprehensive strategy pandemic preparedness and issuese needs to take exactly the ones you have laid out. Thank you. I appreciate that. Ive gone over my time. I like to think that we do not live in a vacuum, so there are other things that will help us succeed and we want to look at whatever we are prepared to help everyone get them and be able to get through this pandemic in the country. Thank you. Thank you, senator. I have got a number of questions i will continue to ask. The point about testing, i think everybody agrees it would have been great to have hundreds of millions of tests available day one, but it just isnt practical. It didnt happen. This is an star trek where you just say computer, 300 million tests. So, it has taken time. What did not necessarily have to take time was using offtheshelf drugs for early treatment, but somehow, because President Trump allowed the word hydroxychloroquine to flow out of his mouth, all of a sudden that was attacked and poisoned , and we never, ever had the nih, cdc, fda put their weight behind an investigation of that. The full Clinical Trials. I was pushing for that, not pushing hydroxychloroquine, pushing for the science, for studies, but it never happened because, again, it was censored. We talk about the disinformation , not providing the Public Information is disinformation as well. So, again, why i fault the agencies is because they turned a blind eye toward simple, cheap, possibly effective treatments, that by the way, created no harm. Dr. Risch, i think you mentioned i have a lot to go over here. You mentioned that i guess the nonrandomized trials, i guess we would call that observational studies, realworld experience. Really involving thousands of patients, indicated that there was a 50 reduction in the hospitalization deaths. In the saudi arabia study, five time reduction. Now, lets just assume that that is true. I mean, we can also take a look at the billions of doses a year that are prescribed of hydroxychloroquine. Any member of congress has just been handed hydroxychloroquine. As an antimalarial. We treat lupus and Rheumatoid Arthritis. We do not give ekgs before that. The studies i saw early on were designed to fail with hydroxychloroquine late treatment when their heart was already affected by the virus, of course hydroxychloroquine does have an impact at that late stage. But not early. It was being recommended for early use, the first five days. So, when you take a look at the riskreward, now that theres these other observational nonrandomized trials were studies conducted, 50 , or five fold reduction in death and hospitalization versus the almost infant testable risk of hydroxychloroquine and zinc. This has made no sense to me whatsoever. The only explanation is the politicization of it, which i opened up in my opening comments, saying that has been such a shame. I do want to, before i forget, i received a letter and an article from the economic standard submitted by doctor stephen hatfield. The letter kind of explains what i have known about a whistleblower, who was asked by his superiors to work on establishing an fda expanded access investigational new drug protocol. But by his insubordination, he instead went to Janet Woodcock and people in the fda and got the emergency use authorization , which sounds like we are going to expand the use of this. No, he dramatically restricted the use of drugs a chloroquine only in hospital, but i think we all recognize it is probably not particularly effective and possibly dangerous and only on the national stockpile. He knew what he was doing. That is what poisoned the well, that is what created what i call the prescription logjam here. On hydroxychloroquine. And i think affected all early treatment options. It took them off the table. We took our eye off the ball. Thats why i say our agencies failed us. These individual in these agencies failed us. And heres the question i want to ask for you. The circle of empathy. You just talked about how you describe that to me before the hearing. Dr. Mccullough let me say before answer that that this is not just a government culpability and malfeasance with respect to hydroxychloroquine. This is academic malfeasance. There were two fraudulent papers , one in the new england journal of medicine, one in lancet, published by individuals interested in doing evil to the world with respect to a beneficial treatment of hydroxychloroquine. In an unprecedented manner, these two manuscripts were withdrawn after two weeks where they could scare the public and the worlds physician audience. Since that time there have been dozens of im sorry, they were then withdrawn . Dr. Mccullough they were withdrawn. It acknowledged that they were fraudulent papers. They were to scare people on hydroxychloroquine. Since that time theres been dozens of pylon pile on scare tactics. This is people in my field, academic medicine, who are committing academic fraud. I am a cardiologist. I reviewed a paper that made it into the literature demonstrating that hydroxychloroquine causes a heart attack. That hydroxychloroquine 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 in his hands more human hearts than anybody in the history of mankind. I can tell you firsthand, hydroxychloroquine doesnt cause giant scars on the heart, so academic medicine is committing fraud. I think it is committing a crime against humanity. There must be a motivation behind this that is bigger than just democrat versus republican. Im extremely concerned, honestly, about the academic contribution to scare tactics in the world. It is not working everywhere. In india, it is such a crowded country. Ive been there myself. Per million population is a tiny fraction of america. Is it 95 over 700 . And they are using hydroxychloroquine . Permccullough 800 deaths million in america. In india they have less than 100 deaths per million population. The leading doctor in india is willing to come testify to the United States and tell you the reason why they have tons of covid, spreading like crazy. But they are treating it at home with hydroxychloroquine and other drugs. It is a multidrug program, about four or so plus the supplements, and theyve handled the infection. Greece, it isnt a third world country. First line youre given hydroxychloroquine. Theres 30 countries that have approved an oral version of remdesivir, including japan. Every country that is actually having a reasonable Public Health response is treating this problem at home. None of these drugs are a cure, but they allow the patient to get through the illness, like myself. I missed 10 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. My wife and i got it at the same time, and because we were treated at home, we were actually able to stay at home so we didnt contaminate other people. The Current Program thats supported by the minority witness in the National 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 to urgent care and ers, 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 dr. Mccullough and vice chair of medicine at baylor, i believe harvard trained, doctor yale, dr. Fareed , harvard trained, 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 three doctors in front of us . This is not for you three gentlemen. Do you think they are just idiots . Again, you are very authoritative and refuting what these gentlemen are talking about. The disconnect, this is what America Needs to evaluate. Ok . Opinion ofwhat your these three gentlemen are here. Dr. Jha 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 reasons to doubt any of that. My problem here isnt so much that we have a different reading of the literature, which we clearly do, but its the idea that there is a broad conspiracy across hundreds of thousands of doctors, the nih, the cdc, all academic institutions, and the 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. Ok . I dont think anybody so quit using that word. Something has happened where we havent devoted any time or energy or resources to doing what could have stopped this covid crisis very quickly. And that is called Early Intervention, early treatment. Ok . Dr. Jha 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 controlled trials of outpatient therapies. And what i have said literally from march when this issue first came up, and i have a long track record on this, 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 outpatient setting. They just havent worked. That is disputed. In your testimony i am telling you, this information is a scare tactic. 90 increase in reports of poison. Then you heard what dr. Mccullough talked about. We are talking out of half a Million People that took hydroxychloroquine, another 77 called in and two thirds of that was they thought they maybe took an extra dose and were concerned about it. So you use a scare tactic of saying 90 increase of poison in hydroxychloroquine, went its an infinitesimal impact, but it is in a normas an enormous disinformation in terms of your commute occasion. Dr. Jha can i have a chance to respond to that . First of all, i never said the problem with hydroxychloroquine. You made the claim it was unsafe in your testimony. Dr. Jha let me finish that thought. I didnt mention the 93 . I could have mentioned the fact there is more than 76,000 incidents of toxicity reports during the middle the pandemic. The bottom line is every drug has some safety issues, including hydroxychloroquine. If it is effective, we should use it. That ishat to me, not the most compelling issue. I think we should focus i do not think we should focus excessively on that. It is clear the therapy does not work. If future data shows that it does, i will be the first to support it and to promote it, but i have to be driven by data and science. There is a real dispute by the four members of this panel. I understand i selected three and they selected you, but there is a real dispute. By the way, these are not the only three people. Take a look at the riskreward ratio. Take a look at the observational success. The firsthand knowledge of treating people with success. And realize the risk reward ratio would be in favor of giving a shot. I think me, as a human being, 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, nih, and the fda. That is exactly what has happened. I cant get it. Millions of americans cannot access it because of the disinformation, the scaremongering, and the prescription logjam that has been created by bureaucrats. So you can sit back and go, oh, it has not been proven effective. Well, they never pushed trials to really analyze it. And i have some pretty eminent people and from tummy in front of me who completely dispute that. You can sit there with all the authoritative voice you possibly have, we have some gentlemen here who are treating patients within the empathy circle that completely disagree with you. I will turn it over to senator peters. Off. Opped dr. Jha, you want to respond to that . Dr. Jha i do, sir. You can say, well, i disagree with dr. Risch and we have a disagreement. The way i generally tend to adjudicate these things, i will read the literature and form an opinion. But one of the questions i ask myself is, am i missing the vote on this . We can always be wrong. But at that point we look to consensus opinion among experts with Infectious Disease issues because they are made up of our leading Infectious Disease experts. Isda does not recommend the use of hydroxychloroquine for covid19 and recommend against it for inpatient therapy. I will turn to agencies like the National Institutes of health , i will listen to people like doctor francis collins. The point is the idea that these are all individuals with incredible expertise looking at be that i amld it wrong and dr. Risch is right . Sure, people can disagree. But when you look at the broad consensus in the Scientific Community it is very clear that hydroxychloroquine is not effective. When we have looked at the outpatient setting, and i started with this in my testimony, we do not have great data. We have a small number of studies. But the best one of those showed it did not work. Could we get better data . Absolutely. So senator, i would love if you push for better quality randomized. Have, i have, i and they wouldnt do it. I have had a direct pipeline and i cannot get them to do it, which again begs the question, why not . This is an enormous dereliction. You can maybe turn to those different places, but as a patient myself, i wanted to get hydroxychloroquine and i could not get it. I think i should have the right to try and dealing with my doctor who i trust, im sorry , more than some of these are who are so outside the circle of empathy, and for whatever reason im sorry its just me , but i question the fact because the cocktail cost about 3000, remdesivir cost there is a little bias or conflict or agenda. When you are in an ivory tower and not dealing with sick and dying patients. Now i want to talk about remdesivir. The three of you here. Talk about what the study was on remdesivir. Is,strong a science that and what kind of dangerous side effects remdesivir causes. And yet, that is the drug that has been pushed. That is the one that got the emergency use authorization. So, whichever one of you feels you are most qualified to talk about remdesivir. I would just make a few comments to just say that with any one of these randomized trials, even remdesivir, in my view, in my judgment of the evidence they are all inconclusive. In many of the inpatient studies, do you know the endpoint . The physician decides. The physician decides how much oxygen to patient news. They change on the ordinal scale. The entire randomized biopharmaceutical complex right right now is corrupt. So that they did is mixed. I just had a patient died this week. It is too toxic. Had liver toxic for the liver toxicity. The problem is virus was replicating to be sago. By the time he got to the hospital, the virus has done its job. So to test a single drug like remdesivir late in the illness, this is no different than hiv. You need multiple drugs of front. The best we have right now are these mixes of vitamins, supplements, and the generic medications. Drugs they some oral are sponsoring with pharmaceutical trials to move forward. If there is an oral drug tomorrow that can fit into treatment protocol, it is ready to go. You can plug it in. The nih and biopharmaceuticals right now have delivered zero oral medications to doctors in practice. Zero. That is our batting average right now. For all the science we have put into this right now with the greatest firm suitable needs in the world greatest pharmaceutical companies in the world, zero oral medications. The study conducted on remdesivir, very late in the trial because it was showing no improvement in terms of reducing deaths, but it was showing improvement in terms of the number of hospitalbased, bays, that they switched the outcome. There are so many flaws to the Clinical Trial people are looking to. One rule is we never change the primary endpoint. The number of days someone stays in the hospital is not objective. Thats determined by social delays, and Everything Else. So none of the trials. If he was to use the word evidence, evidence, evidence. We are in a crisis. We need the art and science of medicine. Patients using the sequence multidrug approach at home is the only chance to reduce hospitalization. Remdesivir does not prevent hospitalization because you have to be in the hospital to get it. One thing i completely agree with dr. Jha on is the workforce issue. Our hospitals are not currently overwhelmed, but they may. The biggest problem is they dont have the workforce. To, had we, speaks really focused on early treatment and prophylaxis, you might have a more ready workforce. But you have nurses and doctors staying 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, to me, the key ingredient to solving this crisis, which is early effective treatment. We should be pouring billions of dollars. But because of the scare tactics with hydroxychloroquine we scared people away from participating in the trials in the u. S. They tried to do a study and they could not get people to dissipate. Dr. Risch, can you talk again about the difference between a random control trial and a nonrandom, or observational studies, or just realworld experience and the validity of all . Dr. Risch let me start with the last point, realworld experience. After i published my paper in the american journal of epidemiology and may, i got emails from clinicians across the country saying they have been using hydroxychloroquine very effectively. That is wisdom of people always cherry pick themselves to tell me that they were doing well, and all the people who were not doing well did not report it and did not tell me. So i said to two of them, ok, go back, keep doing what youre doing i will follow up with you in a month or six weeks and see how you have done after that. So we are no longer cherry picking. We study them as candidates for their treatment plans. After six weeks i went back, and what i found was the doctor who treated another 400 patients with no deaths, another 400 high risk patients. He treated 3000 patients. Since the first time that i talk ed to him, no deaths. The other doctor had 180 patients subsequent when i talk to him and he had one death. So their real world evidence is such no rational person would say i will not go to them. They would be the first person i would go to because they would prove they could do this, it is working, and they are saving patients. Just real quick, he said there was one death. Covid, notrom hydroxychloroquine . The person had a heart attack that was out of the blue. He finished the treatment so he wasnt sure if it was related to covid so its not even clear. It was an elderly man. Thats the first thing. The second part about real world evidence and non randomized trials is the real benefit is if there are the unknown variables and the known things you can adjust for and matching your study, can you can remove them for bias so that you can have a pure treatment between the people who take the drug and the people who dont. It is only the unknown variables. The reason why these nonrandomized but controlled studies have converged to a randomized one is we have learned enough about the diseases that we study we know what else to measure by enlarging every one of them, so we measure everything in the world and we control for them. That has removed the socalled unknown bias and thats why theres a difference in non randomized trials now compared to the 1950s when we did not know enough about what to measure and how to control for it. So that is the second issue, that empirically we know that nonrandomized but wellcontrolled trials work just as well as randomized once. You mentioned the data. It is submitted and fully under the peer review process. His superb outcome. I want to talk about the practice of medicine versus following protocols, which i think we all agree, if you have a scientifically based, randomly controlled protocol on treating people, you do it. But not every person is the same. They do not all react to those protocols. Correct . At that point in time, even with a well established protocol, doctors have to shift to the art and practice of medicine. Correct . Particularly in an epidemic. Dr. Fareed, can you talk a little bit more in laymans terms about how medicine has advanced . Based on just doctors being doctors and practicing medicine, in an emergency. Where world war ii was penicillin and the cholesterollowering drugs, and how those doctors using their training, seeing a drug that can do something for improved use over here says it just might work over here. Or have a patient where the protocol is not working, i have to try something, i want to save your life. Can you talk about how you approach those situations . Dr. Fareed yes. That is so important, particularly when you are on the front line. Pandemic, war in this an my colleague and i took it wasive approach, and using the art of medicine, using the principles i have learned. It was 50 years ago. I was lucky to have gone to harvard. Evn treats dr. Jha patients, the way 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 of where there has been a benefit. Whether it is hiv, making account tale making a cocktail. Pour in the covid situation found ourntinually treatment to be very effective and reliable. And we adapt it. When im in the hospital seeing notents come in, i do immediately put them on remdesivir. If it is a mild type of pneumonia they have, i will prescribed are cocktail on the hospital along with convalescent plasma. And those patients walk out in four days. So, its important that people be respectful of the options that may be there, and use an art in their approach. Announcer dr. Jha, do you wao respond . He wondered if you have treated patients. Dr. Jha i have spent the last 20 years taking care of veterans in the v. A. Healthcare system and recently switched from the boston v. A. But as a practicing physician , i think a lot about the evidence. Me tok my Patients Want give them sciencebased treatment. Obviously every patient is different. Every single time i see a patient i do think about how to make adjustments, but i am always guided by the science and evidence. And when there is no science or evidence about something, i am very careful about that. Because the history of medicine is one of often doing more harm than good. Practicingth as a physician is to do no harm. So im very much driven by that. I started off saying all three of these gentlemen strike me as smart, committed and caring. I would appreciate a similar respect back. I do care for patients and i do my best buy them. Obviously im not perfect, but i try to use science as well as compassion. Have you treated any Covid Patients . Dr. Jha i have not, sir. About fareed, you talk other doctors. That thee of the fact doctor in france is now being prosecuted . Dr. Fareed evidently, that is the case. That is 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 accurate related accolated incredibly when this is over. Hes now using a drug that has been around for 65 years prescribed safely without ekgs . Dr. Mccullough having close communication for the worldwide disaster with many countries, i can tell you i did a program with the Covid Medical Network in australia to show you how offkilter the world is. In queenslands, australia, a doctor will be put in jail for prescribing hydroxychloroquine. I mean, if we go over to india, they give it to you right away. In greece, it is in their guidelines. It is over the counter in some countries. Dr. Mccullough my point is they give the first line in their but innes in greece queens land you get put in jail. 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 four prescriptions for hydroxychloroquine. Four. She was issued a grand jurycan . A doctor prescribing an approved drug and she gets a grand jury subpoena. Somethings not right about that. I checked into it. They withdrew that subpoena. There is something that has gone wrong here. There is something that is not right. I for one intend to get to the bottom of it. Of you, thank you for being doctors. I mean that sincerely. People who have dedicated your lives to help save other peoples lives. There is something to be celebrated. Persecutednot be because you are trying to save lives. Because there has been politicization of a particular drug that has been around for 65 years. There is something wrong here. I want to thank all of you for being doctors. Thank you for your testimony. I hope 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 deaths and hospitalizations. I am for letting doctors be doctors and Practice Medicine and have the courage. There is no other option. 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 talked me out of using it. I never developed a symptom. Maybe im just a lucky 40 percent but i will tell you one thing. Symptoms, iped wouldve found a doctor to try hydroxychloroquine. I think the risk is so unbelievably low. I wouldve tried it because i dont want to go to the hospital. I think most americans, if they think rationally about things, 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 raked over social media. We will be censored. Your video describing what you did, part of a trial, was pulled off of youtube. We helped you get back on youtube. There is something going on here. I hope the American Public listens. I hope they Pay Attention. Upope, i hope we end developing early treatment for covid so we can get this behind us. We are all sick of it. We want cures, therapies, the vaccine. We cant wait for the vaccine. We have to take action now. Thank you all. The hearing will remain open for 15 days for the submission of statements for the record. This hearing is adjourned. [inaudible conversations] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] [captions Copyright National cable satellite corp. 2020] [inaudible conversations] [inaudible conversations] [inaudible conversations] with coronavirus cases increasing across the country, use our website to follow the trends. Track the spread with interactive maps and watch updates on demand any time at cspan. Org coronavirus