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 UniversityMedical 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 professo