Own microphones pretty please keep your microphones muted. Especially love your family dogs, finally, members of documents on which to submit to the record. Address are circulating prior to the steering. Welcome to the First Virtual hearing on investigation of oversight. Today critical issue. Repurposed income existing therapeutic drugs of the covid19 treatment. As well as the scientific basis of the evaluation of such drugs. Appreciate our witnesses being here. These are very important issues and we look forward to addressing these. One of humanitys most promising Public Health response the current pandemic. Repurposed sing existing therapeutic drugs for the covid19. Repurposed sing existing therapeutics and that these drugs have already been developed and manufactured read in some cases quickly accessed. And been approved to treat these diseases and certain amount of safety data is often. [inaudible]. Existing therapeutics, potentially offer an occult assistance for severely ill patients. And do more prevention and Treatment Options to come available. And with great promise, comes with great concerns. Such existing therapeutics, have demonstrated benefits and other circumstances. All too easy in the midst of a pandemic to cut corners. And take short cuts from longstanding processes. The evaluation process, the repurpose of group drugs there for a reason. To ensure that the therapeutics in which could very significant held risk for the covid19 patients. In scientific and medical data reading in section on the basis of actual evidence regarding safety and in their new context. And while the process itself should be flexible and possible, the integrity of the process must be firmly upheld. Evidencebased evaluations for the therapeutics must be paramount. In clinical situations must never enter into the equation for any specific treatment. Politics, should not interfere with the Scientific Research. And the republic, and uphold so that they may be shaped. Impartially, consequences of some interference. And controversy surrounding to existing therapeutic drugs. In the fda issued in march, on these drugs, for the covid19 treatments. But Scientific Evidence to support this decision was dangerously thin. But the Political Considerations were clear. And president became a cheerleader for both drugs. One was hydroxychloroquine. This was all questionable decisions. The lack of insufficient scientific basis. And out months later, about the emergency use and authorization acknowledging that Clinical Data showing drugs may not be effective to treat covid19. And then the potential benefits do not outweigh the potential risks. This is a crude example of the dangerous Political Considerations to distort and should be scientific process relying upon unbiased evaluation. In this chair will explore the importance of supporting Scientific Research and the repurchasing current therapeutics. And as covid19 treatments. And when politics intrudes, and Research Availability is currently engaged in a heroic effort to explore therapeutic things impossible for the covid19 treatments pretty there may be more that we can do as py makers to provide researchers in the funding and the conditions they need to make progress. Theyre also more that we can do for the integrity the role of science on foundations and the efforts in this area. Our witnesses, in this perspective, our experience in this area some look forward to talking to them about the most effective way to support research and repurchasing his existing therapeutics. And on this pandemic and probably unfortunately, probably for the next one. Thank you all. And now the chair recognizes the next person pretty. Thank you to everyone for the participation today. The covid19 pandemic is unlike any and like the 1919 spanish flu. Theres very few things as well as for the virus. Without you trying to produce a vaccine. Thankful that it has changed. Our Nations Research including government, convenient in industry. [inaudible]. Resources and talent needed to fight this pandemic. The work there enjoying, screens potential treatments, and truly lifesaving things. Supercomputers. Things are being used for the covid19. New vaccine developments to repurpose existing therapeutics. Americans scientific as he did the call to action. And an example of the publicprivate, leveraged technology. With the covid19 High Performance computing. [inaudible]. So this collaboration, covid19 researchers scanning access the most powerful Computer Resources in the complex models to addicts tarnishing speeds. By leveraging resources, and Artificial Intelligence and techniques. Researchers can develop and determination say, which root has the potential to repurpose against the covid19. As we discussed previously technology can continue to play a Critical Role in saving lives and preventing spread of covid19. Our federal search, access to resources, and Technology Necessary to do their jobs. And to do it well. That is why i introduced the covid19 research act of 2020 rated insert Agency Working for them to establish to address Infectious Diseases. Additionally, Infectious DiseaseResearch Program over the next few years. Working together nationally, this Program Gives us this ability to utilize the federal government Computing Resources and to respond to Infectious Diseases. Our National Labs have demonstrated the High Performance and advanced Research Facilities model developments. Understand its predicting it spread. There is work underway through our national, particularly relevant to repurpose and therapeutics if i covid19. Thank you doctor stevens for being here today. I look forward to learning more about this important work. I would like to extend my thanks to the entire staff. Researchers and lab after left, and immediately to fight this covid19. When i began serving as a part of the memor committee, whatever important responsibilities is to tell the story of science. Make sure constituents understand the Research Writing this story in particular, our american scientists researchers and engineers responded to covid19 as everyone to know. I went college will use this hearing for more opportunity to share the story. Thank you and of their members who wish to submit additional opening statements, they will be added to the record at this point. Our first witness is doctor murray. The president for public interest, a nonprofit Advocacy Group based in washington dc. He held several positions at the food and drug administration. Including the state of the fda commissioner Public Health strategy and analysis. He served eight years the top official of the fda. Next witnesses doctor james. Doctor finnigan as a director of respiratory excellence in National Jewish health. Nations leading respiratory hospital bradys also the medical director of the Lung Cancer Screening Program at the national. Doctor finnigan is a Research Focus on noncancer and injury. The third witnesses doctor stevens. Associate Laboratory Director for computing and Life Sciences and a national laboratory. He also serves as the leader of skill computing. He worked hard down labs. Our final witness is associate witness, in a hospital in boston, massachusetts. Hes also Research Fellow at Harvard Medical School. Academic research it focuses on the fda approval process for drugs and medicaid prices. In the effective federal policy regulations on drug pricing. As our witnesses should know, each of them have five minutes. The written testimony will be included in the hearing. When you of all completed to your testimonies, each member will have five minutes to question the panel. If there is time, we may be able to have a second round of questions. We will now start. Thank you chairman. And committee members. I am defining as drugs which is second indication for covid19. Some of our witnesses may have definitions. Unfortunately, wait unmistakably for these drugs, is not enough size and sobering effectiveness from one condition does not guarantee effectiveness for a second. The populations may be demographically medicaid differently. So even the existing Safety Measures may be irrelevant. [inaudible]. So lets look at these two drugs. The antimalarial drugs, hydroxychloroquine, and concerning them together likely have a list of candidates for covid19 right and may not be in march 25th, the president described them as one of the biggest Game Changers in the history of americans. And later stated that he was taking the drug himself. The ultimate celebrity. And on march 20th, under pressure from the administration, fda lost drugs in emergency use organization. But the evidence provided was less than that provided. Eventually the scientific plane is about friday studies and demonstrating no benefit for the drug raymond indicated that mortality rates were higher pretty but the warning that the drugs lifethreatening arrhythmias. Finally there were two controlled trials. The first suggested the product was ineffective in preventing infection. In the second also infected intriguing infection itself. In the fda. First we should adhere to accepted methods of birth discovering even in a pandemic. The painstaking process of conducting randomized trials. Even if it is evidence of lack and second, patients in the presence, did allison newsprint lifethreatening arrhythmias were fairly common. Even in patients without covid19 severed. Does this leading hydroxychloroquine approved, and difficulty in obtaining the drug. Finally, the announcements distorted research for covid19. Its inconceivable left to their own devices, scientists the design of our 150 randomized controlled trials. Assisting the effectiveness of these drugs. How many were left in studies or understudies is a researchers had to address the headlines. And second problematic, is over the counter drug also seemingly unlikely drug for covid19. Another doctor, on the assistant secretary for preparedness. [inaudible]. Under the direction, after callahan and begin before the drug rate Pharmaceutical Company in the hospital to prepare to connect to trial community. In the order hefty 1 milliondollar contract for immunity pretty senior officials were cut out of the process. There are two other prominent drugs we are mentioning here. The only drug so far against stars. Elisa my definition, its an unapproved drug. It demonstrates the effectiveness in a study funded by nih. The second drug, is the first drug to potential locality of the nations with covid19. This drug is a matter of definition. As long been approved, often considered the general treatment for respiratory illness based on a. But the benefits of these two drugs will demonstrate the oldfashioned way. Rigorous randomized controlled trials. Interestingly, results are provided from the same british study that reported the ineffectiveness of the hydroxychloroquine. Tested multiple candidates. In the Clinical Trials in the United States resulting in studies often the same drugs listen patients struggling to have more patients. In conclusion, so far this pandemic, effective treatment has not been identified by an antidote in which we are taking, president ial announcements, and questionable practices. And identified instead by transparent systematic applications very scientific principles and for decades has delivered safe and effective treatments. When we departed from these principles, precious time was lost and resources were squandered in some patients paid with their lives. Thank you. Host in our next witness is doctor finnigan. You are recognized for five minutes pretty. Guest thank you. I would like to thank the members of the subcommittee to speak of my experiences on the clinical investigator during the covid19 enemy. I am a pulmonary, icy patients in intensive care units for National News help is leading respiratory hospital in the nation. Only dedicated exclusively to medical research and treatment for patients with respiratory cardiac and immune related disorders. We work in the federals hospitals in colorado rated to provide preliminary and critical and it new york, partnership with health systems. And in philadelphia read close to two decades of Clinical Research and currently help lead our covid19 clinical Research Program. This pandemic has required reorientation, our clinical and Research Programs. Clinically we reorganized our workforce and finds to diagnose and treat covid19 patients rated simultaneously planning for the worstcase scenario. Research operation is something the existing study concerning new studies and as quickly as possible and our staff is working remotely. Any of them are science investigation to target new treatments. We have gone from zero and 20 clinical studies to ten or more therapeutic trials in various areas of development over the past four weeks. Prior embarking on a Research Study, each trial requires timeconsuming steps including critical review, assessment of our ability to perform the trials, determination of any complex with ongoing trials, and negotiations an agreement on terms. This process ordinarily takes three months or longer. During this crisis, we been able to cut the tension of a few weeks. For a Pharmaceutical Company are other, this process must be repeated at every site. As an example, i recently published study at 15 sites. Reflect our experience, the National Jewish help during this pandemic. I believe threepoint should be highlighted prefers to rapidly deploy Clinical Trials for repurposed or drug, preexisting organized networks is essential. Recently announced nih led, active accelerating covid19 therapeutic interventions. Publicprivate framework. [inaudible]. Another example is the prevention and treatment of acute networks. This dedicated to 2 million in acute respiratory this being because clinical features and possible treatment to covid19. For the past month, the network developed and launched to research protocols. They will more likely be completed in the next coming weeks. Used in collaboration a platform to launch quickly and his study. And we need to Ongoing Investigation is a covid19 to understand the virus. Much of this research will be what we call preclinical studies. Animal models to our understanding of the covid19. However this can only exist if we are in Robust NationalLegal Research infrastructure. This kind of research are not always immediately apparent. However the understanding underlying sides of this disease will drive development with new deputies moving forward. In studies can help identify which neutrons are most promising and getting to a rational strategy and for are interesting these drugs. Another benefit is likely in the future. With that will be, we dont know what we should be planning out on how to incorporate a full Research Operation to any future pandemic response. Ive been impressed with the Research Community research. Even with this effort, it cannot be launch for several months into the enemy. Should be performed and how it will be executed with the perspective roles, as well as industries who continue. Research is an important to do anything this pandemic. And be ready for the next one. And the personal protective equipment, and the ventilators. Thank you. Host the chairman appreciates your accuracy pretty will now recognize doctor doctor stevensr five minutes. Guest . Host lips. Guest members of thesubcommitter alignments this opportunity to talk about the covid19. My group, my collaborators worked for nearly on the components in the spring and we talk a little bit about this. I am speaking for argon Party Consultant for argon. My work focuses on the problems in science and on the medicine. I work in this for over 25 years. In related to covid19, on the cares act, and the laboratory project, and molecular design for covid19. As part of that effort, were looking at the purpose on the compounds. About the virus, and why the search project was actually challenging. And that virus accounts for about two thirds of the proteins. [inaudible]. Of those proteins, perhaps in the virus accounts for the targets. And also, perhaps interactions for them to occur, many of those host protein. Its also important to know that this virus is very closely related to sars one. And then we have access to the genome. And we are working on one. We have structural mass of the protein. And requiring to more. [inaudible]. How existing drugs interacted with this virus. And to a large scale, large skill when additional work pretty with my collaborators at the university of chicago, and the laboratories