Transcripts For CSPAN2 House Hearing On Coronavirus Response Drug Treatments 20240712

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 Disease Research 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 National Legal 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, are looking at other proteins, but only 2500 or so licensed drugs worldwide in 7000 or so drugs but literally that some can exist. But in an effort, is also critical with infrastructures. Supercomputers, relapse,. [inaudible]. Structural potentially inhibitors fountains protein our unit and looking for a vaccine. And critical to this effort is the nih bio containment laboratory. The student after 911, and the emerging concerns about these pathogens. And they exist at other locations in the country. Were also using laboratories with the university centers. They can mark on active virus. Essentially the viruses are not alive but they have a lifecycle. So essentially, we can use the computers to search for to clean all of the repurchasing drugs and on each individual molecular targets prayed and they appear to have a high potential and collaborators, and ultimately to the people. Just one more thing. One thing is holding us back, only back the community. The lack of biochemical, for the specific protein functions. The investing, and the laboratories are investing. Theres a major bottleneck. And part of the National Critical infrastructure and made available in laboratories to ensure rapid happenings on any outbreak. And thats it. Thank you. As opposed to what has happened in the United States in terms of the coordination of the large number of Clinical Trials. Could you say a little bit about what we get right . If it is better or worse than what was done other International Collaborations and when they are working sufficiently and what are connected to those . Certainly, i think we have known what. My apologies but thank you. I was fumbling with multiple windows there and thank you for that. Doctor, you are now recognized for five minutes. Thank you. Chairman, rigging member and members of the subcommittee thank you for inviting me, i am a practicing primary care physician and help policy researcher in Harvard Medical School and work at hospital in boston. Im a member of the pharmaceutical epidemiology and pharmaceutical economics and therapeutics in a Research Study group that has [inaudible] im honored to be here today to talk with you about the process for studying and approving repurposed drugs during the covid19 pandemic. Drug development can be a lengthy process and we repurposed in several medications will be data about [inaudible] as a result for months after the first covid19 patient is reported in the u. S. Several highquality Clinical Trials provided solid evidence relating to at least more drugs, two of which have proven effective. A lowcost generic steroid that can be readily prescribed and antiviral that is not been proved by the fda but is now available under an emergency use authorization. However, we have also witnessed examples of how the process for testing and approving drugs can go awry. As exemplified by the case of hydroxychloroquine we have learned from her past as we move forward and our experiences so far is just for key Actions Congress should take. First, congress should hold all Government Agencies and officials accountable for making statements and acting based on the best available Scientific Evidence. Hydroxychloroquine was widely touted by President Donald Trump and was issued an emergency authorization by the fda based on preclinical and anecdotal evidence that turned out to be unreliable. These actions led to widespread use of the drug which exposed patients to risk, two shortages at pharmacies and diverted attention and resources that might have been dedicated to other potential therapies. Second, congress should invest heavily on highquality Clinical Trials which are necessary for determining whether drugs are safe and effective. Notably, most of the highquality evidence generated so far during the pandemic has resulted from public funding, including the u. S. Government and the United Kingdom government in the case of [inaudible]. While the pharmaceutical industry will continue to have a role to play the federal government leadership and involvement are crucial, particularly for repurposed drugs which industry made little or no financial incentive to study. However, such Public Investment should be made with the assurance that it medications that are bound effective will be priced fairly and distributed equitably to patients who needed them. No american should be prevented from accessing potential lifesaving covid19 due to cost. Third, congress should invest in a Public Infrastructure and that can help shape government academics have collaborated on large Clinical Trials that have multiple repurposed drugs simultaneously. A prime example is the recovery childhood based on the university of oxford this trial has already provided useful information about the lack of effectiveness of hydroxychloroquine and the effectiveness of [inaudible]. Finally, [inaudible] the level of evidence required to meet the standard of an eua should be clarified and to increase transparency congress should compel the fda to make all related data public at the time it is issued. As new evidence emerges the fda should be directed to applied the same standard as was required [inaudible]. It should be accompanied by clear and transparent plan for how the drug will be barely an equitable district needed to patients, something lackey lacking for hydroxychloroquine. Issuance of an eua should be companied by a collection of data on [inaudible] our experience and so far studying repurposed jugs drugs have shown that we may not choose evidence and speed and you can have both. As our fight to control the pandemic continues Congress Must assure that we have a drug approval process that follows the science and the practice of evidencebased medicine. In a recent publishing of medicine we argued that the health of individual patients and the public at large will be best served by remaining true to our timetested approach and Clinical Trial evidence and drug evaluation. Thank you. Thank you. My apologies again. We skipped your testimony in the order. That is the danger that i read your testimony in advance and feel less need to hear it directly from you. So i guess i will repeat my question which is largely directed at your testimony and considered about the differences in the way things are being done internationally versus in the u. S. And what lessons you might learn and from that. Thank you. I am appreciative. Your question is a good one. We have had two successes in the pandemic so far with [inaudible] [inaudible] but the other was what came in from funding from other countries and i can say that most of the large Clinical Trials that are being suggested, especially those that were started very early in the pandemic and will get us results in a timely fashion were led by our peers in other countries and the u. S. Should going for the rumor in his pandemic and future pandemics we will have efforts and become a leader in the world for wanting these to go to clitoral trials. In the case of antiinflammatory [inaudible] was not funded by the manufacturer because one of the things that worries me is that if the majority of our Clinical Trials are funded by manufacturers then they will get those drugs do they have property or manufacturing position and that we [inaudible] was that handled differently than other countries in the u. S. Or are essentially all trials worldwide funded by the manufacturer . No, not all trials are funded by the manufacturer. It was funded by the government. [inaudible] is a generic drug [inaudible] that is likely to be true of many of these repurposed drugs which made the older off patent generic drug which are available and great for patients but not necessarily a good investment from the perspective of the manufacturer but not only that the true Clinical Trial from remedisivir itch is still a patented drug owned by gilead and the key Clinical Trial on which we are moving that drug was funded by the u. S. Government by the nia ib and so this is a case for they should have been running the key Clinical Trials and instead ran a Clinical Trial testing two different versions of the medication against itself leaving the key clinical travel to come to the u. S. Government and they have a patent on that drug and can financially benefit from it when or if and when it gets fda approved. Thank you. Doctor, any comments on what is done internationally versus the u. S. And lessons we might learn . I think what he said was spot on the money. Unfortunately, things have been to a certain extent delegated to ensure the pharmaceutical industry to an individual and academic institutions but what we really need someone to coordinate this whole thing. I know the nih would like to do that and i know bush government had successful recovery trials but we need a stronger hand on the rudder. Someone to [inaudible] and to stick with the usual game plan and there are so many patients i am sorry to say and the disease makes you feel so quickly, im sorry to say, that theres more enough statistical power to do the randomized controlled trials which we expect drug approval to be based on paid lipstick with the methods that work and use the pandemic as some excuse to corner cut the regulation. That is interesting. Could there may be opportunities we are overlooking . Or clinical outpatient trials, to have a certificate scientific Clinical Trials if you had some fraction of the large number who tested positive or were immediately given the option of being screened and on an outpatient basis that we could have understood and have safety concerns. There are opportunities we should think about. I think so far if you look at the totality of the research that hasnt been done most is based on the communication settings and that makes a certain kind of sense but these are the patients after all and i agree there is opportunity but i do mean that as a criticism to date. Alright, that concludes my limits and so i would like to [inaudible] thank you, mr. Chairman. Could you provide us with an example of Cutting Edge Research capability unique to the national lab and how helping researchers look to repurposed scene existing drugs . The best example is the use of the source to quickly to produce a new structure bound to a drug so with this is critical to understand the targets and that the drug is working on and to understand how it changes the structure of the protein when you interrupt its function so thats a unique capability. Only a few cases in the u. S. And world that can do that and quickly and the appearance and argon [inaudible] could you, along those lines, explain how Argon National lab is working collaboratively with other Research Entities toward identifying covid19 drug candidates . We have a consortium which includes argon, berkeley [inaudible] some National Laboratories in the Pacific Northwest working together we are using [inaudible] to computationally screen drugs, billions of drugs. Billions of potential drugs. All the existing drugs and the drugs [inaudible] [inaudible] [inaudible] [inaudible] we will discuss positions that are on the front lines so people benefit from their advice [inaudible] as i mentioned earlier, we focus on collaboration with federal agencies to create a National Strategy for any Infectious Disease outbreaks from place in the future and certainly we will face those in the future again as the chairman alluded to. Are there any other collaborations that we are not thinking about that will help you . Early on we established collaboration on the National Labs, nih, and we have activities and Research Groups and i think what is needed with in the bill is a sustained ongoing network of Research Collaborations consistently working on problems and sharing data and seeing information when it could involve the nih or result in [inaudible] essentially, all the players that are necessary for the integrated [inaudible] one last question, doctor stevens, is there Anything Congress can do to help Fund Researchers like yourself to do their jobs more efficiently during this pandemic and bring us one step closer to ultimately a cure . I believe the current activity is exactly what is needed. The funding, support, these new efforts are critical and we are not out of this yet but i believe [inaudible] the clinician process is working quite well. I believe the institution to put together structures to support this and the department of energy, for exam, created the Technology Lab and it supports all the labs in the u. S. To drive toward a coherent covid19 strategy and i think that is working. Continued support for that level of activity is what i would recommend. Thank you, doctor. Thank you mr. Chairman. Thank you. I will not recognize representative [inaudible] for five minutes. Thank you, mr. Chairman. Can you hear me . Yes. Thank you to the chair in the Ranking Member for our Witnesses Today and thank you for your expertise. We know covid19 is disproportionally affecting black, indigenous and other people of color and that they are contracting the disease and dying at alarming rates. As researchers to develop studies and carry out trials the administration and congress can must address these disparities and you can encourage or require research that deliberately inclusive of all demographics and effectively addresses these inequitable outcomes. Recruiting patients to participate in research, we understand, can be challenging even under ideal settings but trials can fail if there is a lack of patient enrollment. For valid reasons why a patient invited to take place in the study may not trust medical researchers or feel comfortable participating and even once a willing participant is identified there can be barriers to their inclusion. A recent political article talked about physicians that are conducting nih funded Clinical Trials for remedisivir, a site in boston, new york and atlanta. Language barriers and recruiting patients with limited English Proficiency did not have consent forms in spanish and they had to work with translators by phone to explain the study and get consent and it took extra hours for patients so i know doctor, you mentioned this that to the witnesses all agree that its important to have diverse representation and studies and trials connect do you all acknowledge that is important . If i may, i most certainly do. Ive not seen specific information about recruitment and how it might be divided by ethnicity but i do know that this is a non equal opportunity virus. In full stages of this disease African Americans and people of color [inaudible] they are more likely to be exposed to the virus and therefore more likely to have be in crowded Living Conditions or in prison or healthcare workers and the front lines exposed to the virus. After that, they are very often have difficulty gaining access to treatment, in part because of lack of Health Insurance and within the hospital the outcomes have not been across ethnic groups and perhaps because significant underlying healthcare conditions as well. I appreciate that but i dont mean to interrupt but i will ask you and doctor finnegan, are there strategies to get diverse representation in testing and trials . If not, not only the government but what can the medical community do . Do you have suggestions on how to build trust in the communities where they have historically been excluded from government funded research . Okay, thank you. First off, you are correct. I have seen firsthand in the covid19 pandemic where there have been examples of people who were not recruited adequately or were not recruited because there was only which barrier there is not an appropriate consent form and that was particularly challenging for people who only spoke spanish. One important thing to note is there is always a time in which you can recruit somebody so you typically cant recruit somebody into the study and an unlimited time window. You may have to do it within 24, 48 hours and being positive so there was a race against the clock and so those barriers really can add certificates of meaning. Those need to be taken account ahead of time. It is relatively common that africanamericans, latinos, non whites are underrepresented in studies so being ready for that kind of thing ahead of time to make sure they can get adequate we involved all the resources are available in those things are critical. I know studies where they got those kind of resources and consent forms but it happened weeks into the trial and so you lost time and you lost patience and the other critical piece there that i thank you are also getting at is thats a loss opportunity for that person to be in a trial. Our goal is to get every patient the opportunity to enroll in a trial if they want to. If you cant and roll them because there is not an adequate consent form, lets say, thats a missed opportunity for that patient and they may lose the chance of being in a trial on remedisivir or where there is a potential benefit. I appreciate that. There was an article this morning were now this talk this week about the steroid that has been hailed as a breakthrough treatment but there is evidence, according to the chair of the pharmacology at Johns Hopkins University School of medicine, the African Americans may respond differently to this type of steroid. It is so critical that we address those issues because as we know covid19 does not discriminate based on these race. Its disproportionally affecting people of color print real quickly, doctor finnegan, we know repurchasing existing drugs is an attractive option because medication that has already gone through testing, can you tell us more about how Clinical Trials phases can be safely accelerated if the drug has been approved for another use . So, there are so there are different ways this can be done. The key is to have a integrated network so you can get and its been described that there are things you do in silicone a computer where you can rationally identify drugs so for example, i was a part of a study where one of our investigators builds essentially a Google Program where you could put in drugs and then put in the kind of drug you wanted where the kind of protein you wanted to target and then this competed program would spit out the drug that you wanted and you could marry that to an asset or do in the lab or you might have, lets say, 500 little wells and you could test different drugs in each one of those wells. If you could marry those Different Things together and do that and rapidly move that into an animal model. Those things are important to have that full spectrum represented, whether that requires one institution or multiple institutions is important and as we said earlier having these ready to go is important so thinking about what these might be they often have to be with toxicity and whether or not they kill cells or Something Like that in those of the things that need to be thought about ahead of time. Im afraid i have two my time is expired in a yield back. We will have a little bit of forbearance with the representatives coming in on the telephone because they cant see the timer. I now recognize [inaudible] thank you, mr. Chairman. Thank you to each member of the panel. Its been interesting. As we tried to get a vaccine i see that were moving fairly rapidly and i appreciate you talking about maintaining some standards and of normalcy but one question i want to ask here is as we go through this and accelerate these processes can you address and i guess i will just open it up to answer this but how can we maintain scientific rigor when we are accelerating the curatives and vaccines so weve nibbled around the edges here but i am wondering if anyway you see we can maintain that scientific rigor that is no necessary that we can get a handle on this . Well, i think the playbook is clear playbook is the playbook we have had for decades. Its through keeping two strong standards. All we really need to do is coordinate better and speed things up way they do by turning their attention to this and if we keep our standards up i would like to think that ultimately we will have the products we need. That gets me to maybe expand on that. One of the things that we need to be is more transparent and so if you would address that and how we do that and how we could be more transparent . Thank you, we had to examples during this pandemic so hydroxychloroquine was the first one and that was based on little evidence but it was not clear what evidence that the fda he considered and later we learned about what that was going through the fda. With remedisivir we had a top line results published by the criminal trial and not until three weeks later to we have a full data that was released in the journal of medicine and during those three weeks it was shipped out to hospitals that we did not know that this was how to best target or there was targeted supplies. The fda should make decisions in a consistent way to meet the standard. The standard for is that its reasonable based on the totality of the evidence that the drug is likely to be effective. That standard needs to be enforced and when you knew data comes out we need to reassess and whatever data that you use to make those decisions is public [inaudible] great. Enqueue. Let me just go to doctor stevens. Doctor stevens, you mentioned that although repurposed scene may be [inaudible] it is highly likely we will have purpose filled drugs and can you expand how the work youre doing at argon can be leveraged by pharmaceutical companies for specifically . Yes, we are trying to produce a set of qualified leads that we are confident that shows promise in the competition of the work and promise in the initial function as essays but are not fully drugs. These are compounds that we would hand over and say here is all the data that we computed and that we measured and let them take it from there. That has been discussed and it is the kind of thing [inaudible] its a giant funnel and at the top of the funnel give the billions of molecules out of the ten to the 60th molecular version of those that we have thought about and we narrowed that down to a handful of tens or trillions of compounds that it can take in more advanced studies to improve safety and effectiveness and so what we are doing from a Public Sector is essentially that the top part of the funnel in reducing it in an open way is a set of priorities that [inaudible] that is a strategy. Great, great. With that, mr. Chairman, i yield back. Thank you. I will not recognize mr. Buyer for five minutes. Thank you, mr. Chairman. Thanks for being with us. I will begin with doctor rome. One of the things in her testimony said its imperative that we establish a Clinical Trial network and is the one not already exist in that part of that functional of the nih to establish that . Thank you for the question. Yes, certainly we have a Small Network of Trial Networks and that doctor finnegan could speak to this but the nih does, in fact, research itself in the case of remedisivir but in other cases it will outsource to academic and as was mentioned when the study is done in multiple sites theres a lot of regulatory things that need to happen to ensure safety of the critical trial and institutional review boards and that can take a long time and so by what i think the efforts needs to be, Clinical Trials and scientists are ready to go and want to act but that they are super important. Like continued safety and the time to do those things and to cross different sites can be cut down by investing in those infrastructures. The vision has to be that those existing National Network of clinical sites say 50, 300, in the future [inaudible] doctor finnegan, you mentioned that deliberating the structure of the proteins why would an individual hospital made that rather than the National Lens to have all their big computing machines [inaudible] devices and the like . So it has to do with a couple things. Number one, ability to lead people who have that thing and everything is reoriented to covid19 so everybody could drop what they are doing and direct things to covid19. People who have that ability worked on that and it could speak to a lack of coordination of how this would be a tax from the beginning though from the beginning there was not at least not a publicly announced kind of strategy that would clear to everybody in terms of how things were going to happen and how things would get laid out from understanding some of those basic facts to driving clinical triers and that creates a fair amount of duplication and an example of that that there are Clinical Networks that have existed and there are lots that still exist but it took several months to utilize those for covid19 and it is not being used for covid19 trials for a period of time and now theyre starting to get use so it might not be creating a new network but understanding that these things exist and you have a strategy ready to go. Great, thank you. Doctor stevens, fascinated by the notion that the rna translates into 30 specific proteins and you understand the structure of how they are folded in ten and 20 of them are what creates this issue. When you talk about purpose built are you thinking there is a possible and i think mathematically how to tear apart one of those 20 proteins . In the ai models to essentially design custom design inhibit all molecules and [inaudible] that is what the community the can do this in ai is working on. Many groups that are collaborating on this task and in the near future we will have new compounds that are the result of this process that go into the experiments of the pipeline. [inaudible] therapies are often a cocktail of multiple drugs and its a multiple therapeutic mix with multiple targets and targets that would help [inaudible] that might walk a replication or might walk a process that is a problem and so forth and you would probably end up using a mixture of compounds in a future drug treatment and i think its important to say that to develop drugs that were amounting will take a long time. If you think about the hiv time frame it took many, many years before there were effective hiv therapies, over a decade. While we are moving faster we have better tools and this is a very hard problem and its a crisis mode [inaudible] thank you very much. I yield back, mr. Chairman. Thank you. I recognize [inaudible] microphone. Mute. You are muted. Shame on me for it hello, thank you, mr. Chairman or yielding it and not charging me my [inaudible] quite yet. To the panelists for joining us, this is a fascinating discussion and im glad to be here for it. The controversy surrounding for hydroxychloroquine has caused a lot of people to question the scientific integrity of the fda process and the policymaking especially during this pandemic and doctor could you please give us your general assessment of the rigors of fda policymaking and public indications regarding repurchasing of the therapeutic drugs during this pandemic and what matters if anything. I certainly agree that has been a disappointment and i dont think it is because of the career officials who i think are committed to scientific integrity. There are regulatory procedures during this pandemic but i do think people have turned out to be sensible to political pressure. The hydroxychloroquine [inaudible] considerably below what it was in previous uas and i say this based on talking to people who go on to eat uas and previous administrations of to the end it turned out to be a black eye for the agency. Another embarrassment i think is Antibody Test where for a while and agency allows the products to the market without being in the [inaudible] and that turns out to be a disaster when it turned out they were playing by false positives. So now they have. What i hope is from the combination of those experiences you will get a proper use of the process which we are now seen and i sincerely believe that my former colleagues of fda will be able to stand up because it was syrian. How about you . Thank you for the question. What you are getting at is an issue that has come up again and again which has a standard of evidence required for any drug approval and covid19 which traditionally were statutorily exposed to based on substantial evidence so traditionally that meant to Clinical Trials and makes you even one trial that need to get it wrong twice. That has changed over time and it was expedited through the fda process and that is something that needs to be considered and that is the background for when covid19 came weve experienced the fact that 80 of drugs are approved through [inaudible] based on limited evidence and that trial. During the covid19 we provide on the eua to put off the fda approval process before they carefully considered the evidence and makes total sense and certainly time is of the essence but to your point we have very little experience for the drugs and it was done during a pandemic in 2009, 2010 and there it was issued to the u ea and the data that later came out from the google trial that the drug was not effective for the type of patients it was issued for but now we have a hydroxy chloroquine and remedisivir so maybe we hit one out of three potentially but we dont know the full story on remedisivir but this is a time for congress to take a look at the way the uaas have been utilized and to not their regulatory regulation on the fda to make sure its appropriately in the context of the speed that is needed. In the final minutes, my question is that there are a lot of financial incentives for firms to get there eua process and get them approved. How does the fda assessment and illuminate conflict in a drug approval process to make sure there is no conflict in the decisionmaking process . Well, quite frankly the process is with a conflict of interest and there is not much to be done of that. We accept the idea that drug trials and trials of diagnostics were conducted in general by the manufacturers themselves. It is a given that that company will come in with an interest that suits them. That is when the fda comes in and went to review on the actual data itself which no other country in the world seems to do and that is where that kind of review and that kind of insulating from the manufacturing and that is the way it is managed but its a given that most of the time the studies will be done by the manufacturers themselves. Thank you very much. I see my time has expired. I yield back. Thank you. I will not recognize [inaudible] thank you, mr. Chair. To the panelists, thank you all for your testimony. Watching you all, listening to you all watch each other has been interesting. The first question i have, in fact, youve brought up a couple of networks in place that did not get activated promptly so we talked about active in [inaudible] lets start with you, doctor finnegan. The pandemic comes in we see this starting to take a toll so is there some lead agency and does it seem like nih who is it that sends to these networks be okay that everyone has to jump to it whether its the hospitals or the laboratories . To a certain degree the exact agency that doesnt doesnt matter. It needs to be understand i had of time. Whether or not it is the nih or another agency i dont think that really matters but its just a function of thinking ahead of time and doing ahead of time that the networks exist and that you want to put them into action, especially in situations like this where you have made time so we knew about this pandemic for some time and we could have been planning it. It doesnt necessarily matter that the cdc or a different agency, whichever agency funds that network or seems to bring in more than one network that you might need to have cross agencies those things need to be thought of at a time with other aspects like how you do consenting patients should be thought of ahead of time and thats an extreme line as quickly as possible for when you need it utilized. Doctor stevens, when the labs kicked into gear . The labs started to self organize on the first of march. Ahead of the official proclamations we have a little bit of flexibility from the lab and thats why they exist and so we are used to taking initiatives and talking to each other [inaudible] the pandemic was declared in headquarters was supportive that we were already moving and so i think the community i think the panelists would agree that they saw this coming and started to do what they could do in the realm of the freedom of action and in the agencies that came up to speed to start resourcing things. It all happened in parallel. So to all of you from our Science Committee we had a little bit of jurisdiction in respect to hospitals but not a lot but we do definitely have jurisdiction over the laboratories. Is there any connection. The networks that you talked about, doctor finnegan, you talked about the nine labs you are collaborating with and is there any connection between these Hospital Networks and our laboratories that are you talking with each other . Not so much. Department of energy typically doesnt get involved in Clinical Research or in our laboratory does not have online internal [inaudible] related to clinical work. Its largely the distinctions between the agencies in the network but we do have collaborators and i personally [inaudible] i have colleagues in chicago include go trials and i have talked to those people so personally we have context but institutionally the department of energy typically the laboratories they support arent as involved in clinical work. Let me turn for my last 45 seconds. At Harvard National collaborations with colorado and a bunch of others but harvard collaborates with everything around the world and when did your medical school and when or how you do get engaged in this thing . The minute we heard about it with china or how did that go . I agree that the Scientific Community acted early but acting early involves having information and i think that comes from the top in this case. Information out of china was challenging for medical professionals to understand and so by the time that people started to gear up here that made unfortunately earlier had the administration and everyone else in the government to set the ball moving and push for action earlier on. I was remiss to say doctor finnegan helped me on a telephone town hall with 2000 people on the line and so i just wanted to mention that and thank all of you for your testimony today and i really appreciate it. Thank you. At this point i guess there is probably enough member interest for another round of questions for those members who we wish and so we can correctly so this may be of brief round of questions here but i would like to followup on a couple of points. Doctor finnegan, you mentioned the idea and the concept that instead of having to replicate the approval of the remedisivir trial at 60 different locations there could be some similar point of approval and is it realistic to expect that individual institutions will buy into that mechanism that they would be willing to outsource that the approval of clinically trial that may or may not you know be safe which is one of their concerns . The answer is no. They will not give it up but i think there are things you can do ahead of time to make it go much faster. What happens with a trial like the remedisivir trial or other trials we have going on in the industry sponsored reaches out to us, access if you want to be a part of it and we say yes and that at that point you begin the backandforth with the protocols and it goes to our process and we have to approve it to make sure it is safe and discuss the budget and make sure we have to do it and while we are there they do that individually all the Different Things. If we send, lets say, [inaudible] and thats wasted time for everyone. If you have a network like lets say the Title Network i mentioned businesses are in place and network has been taken care of already. That immediate work and legwork in terms of getting things approved and contracting and budgeting that is been taken care of. You can imagine a situation or drug Company Might say i have a drug hiding its promising and i want to use this federally funded network and maybe there is some mechanism they could pay into use that to help keep that up on it but allows them to very rapidly get their drug out there in the process. You touched on the issue of commercial incentives right because that must be very delicate in this because obviously, Drug Companies can get the federal taxpayer to pay for a Clinical Trial for a drug that will eventually say this is something which is currently on approved use but there ought to be a mechanism in place that the federal taxpayer has some benefit that they paid for this trial. There are countries anywhere that have a different model that might be more effective for the commercial interests to funded trials or do they just fully federalize it and theres a big pot of money that and a group of scientists who decide what is the most scientifically promising and allocate some of our Clinical Trials that way . I can speak to what happens very notably in other countries. I will say briefly that there are some examples and i dont know if its quite public, private partnerships but for example, Cystic Fibrosis, the Cystic Fibrosis foundation which regulates a lot of the trials that happen in Cystic Fibrosis and kids and in adults partnered with an industry sponsor on new drugs so they could rapidly get those drugs tested and those were successful and improving and the drug company ends the Cystic Fibrosis foundation benefited from that and i think that could be replicated. I will let others talk about countries. Any comments . Yes, i guess i would say that i dont know of another country or to your question of how that balance is made in other countries for a better job negotiating from a value based prices of drugs so that we do not double pay in pain for Clinical Research and develop the drug and secondarily over high prices. That is one common but the other is again, i mentioned the example of remedisivir which is exactly what you said is a government is funding the late stage Clinical Trial and that occurs in one in four drugs that have been developed over the last decade when the federal government is involved late in the development of the drug and all most every drug has some federal involvement in the early stages of development. Its absolutely a problem and will be highlighted in covid19 and it will affect how the drugs are able to be accessed by patients and they have to pay for them so it needs to be addressed. One of the most potential tragic outcomes is that drugs just wont get looked into if you dont set this up right. At this point im happy to recognize chairman lucas with additional questions. Chairman, i will yield back and [inaudible] politically they are looking for ways to protect themselves for cures. Would like to thank that the discussion that we had this day, to this point, is the underlying issue is we are making progress diligently working to address our constituents and they should have faith in the institutions, both inside and outside the federal government, working together, the Care Industry included, trying to address their needs. These issues, through no fault of their own, but with that i yield back. Thank you. I now recognize representative buyer for five minutes. Thank you, mr. Chairman. Doctor stevens, in your testimony you talk about us paying attention in the long term to the emerging pathogens. How do you define emerging pathogens. Does someone have to get sick before we do it and given the billions of different viruses what constitutes emerging . Most people would agree with the one where pathogens [inaudible] [inaudible] Human Development [inaudible] those lots of opportunities for contact with animals and new pathogens can emerge that way. That is the primary mechanism. If you think over the last decades of viral pathogens, ebola, covid two, these have all emerged from animal reservoirs. My recommendation is that any amount of a scientifically based International Program surveilled wild populations, understand their micro biomes and natural privacies and studies them, the technological epidemiology [inaudible] to understand the reservoirs much better than we do currently and we do in more time to be ready for the next one. Thank you. [inaudible] 10 million molecules are expelled him are available for experimental validation. We talked about [inaudible] will the first funnel be mathematic mathematical . The top of the funnel [inaudible] the Drug Companies have an understanding of over that [inaudible] it would be conceivable to create a panelists for collection of molecules that essentially [inaudible] if you have any emerging outbreak you could swing a very large set of molecules if you want and have a lot of possibilities to chase down and combine that with competition we create a much better situation in terms of therapeutic developments. That is something the community would be excited to workforce. Excellent, thank you. It is amazing that the 100 million molecules, one last question. Your fourth point was making improvements to fda to eua process and you talked about the clarifying and standardizing equitable distributions and Patient Outcome data. Is this something that should be done regularly or is this a Perfect Piece of legislation . Fda has the ability to do some of these things but has not done so. They have the ability to collect information about the drugs but they are not required to and other adverse or safety events at major events that occur from the drug. That can happen but further data has not been required as part of the eua. They have Broad Authority to write into the eua and what it wants in terms of requirements but certainly those requirements and you look at that Broad Authority to be better regulated by congress more directing and saying when you issue an eua these are the things we think are necessary and we have learned a great deal about what would be helpful. Again, or transparency at the outset so that physicians using the drugs have access to data and they are not just data they gave the not even requiring and it didnt take long for evidence to mount that particularly in low prevalence populations certain of these tests could actually produce more false positives than true positives and i think that first the agency to take a look at what theyve done and then they giving the Companies Ten days to comply. Dont know how many of them have met the requirements but i expect certain of those products to disappear because they couldnt immediate the standards. Again, im sorry to say the fda has been flipflopping or coursecorrecting, to try to get this exactly right, and made some mistakes. Can you. I dont know if anybody else has any comments. Want to thank the panel and im happy to yield back, mr. Chairman. Thank you. I have to say i was a little bit surprised when the tests crime out so flawed, there was no one responsible for making in the government for establishing a test panel that you run every one of the proposed tests against. Samples of positive and negative people that would be just at least given to every manufacturer to test against and report their results. And that seems like the sort of infrastructure that should exist somewhere in the future when this sort of thing happens. Also representative byers suggest suggestion of potential legislation and now can have one remaining minute of representative just like dr. Stephen, how often do you see a drug that works wonderfully in practice and not at install theory . Not at all in theory and. Usually, either the theory is wrong so we have to fix the theory if that happens. [inaudible] we have to filter out because youre using approximations to do this. Most of what we look at doesnt work. Thats the reality of developments. Most compounds dont work and so it is a needle in a haystack type of problem, and occasionally well fine drugs that defy our initial view, but those usually dont come from the competitional process because we filter those out. Those come through physical screenings on you have to repeat them. Cant all be computationally driven. I mentioned before large chemical libraries, another resource we need as an infrastructure. I just want to thank all of our witnesses at this point before bringing the hearing to a close. Its very important, and keep thinking as youre doing your daytime job here, what changes youd like to see in place for the next pandemic. Thats going to be a big part of our job to try to preserve the Attention Span of congress so were better prepared. Someone smart opposite say you good to war with the army you have and next pandemic id like a slightly better army. And just thank you all for being part of the army we have. So the record here will be open remain open for two weeks for additional statements from members for any additional questions that the committee may ask the witnesses, and the witnesses are now excused and the hearing is adjourned. Cspan has unfiltered coverage of congress, the white house, the supreme court, and Public Policy events. You can watch all of cleans cspan, created by americas Cable Television companies as a public service. And brought to you today by your television provider. Binge watch booktv this storm. On saturday evening, watch several hours of your favorite authors. Next saturday, were featuring author historyn david mc mccullough. And watch saturday, july 11th july 11th as we feature commentator, author and found of the national review, william f. Buckley. Binge watch booktv all summer on cspan2. This november we are going to take back the house, we are going to hold the senate and we are going to keep the white house. 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