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tv   The Stream  Al Jazeera  October 16, 2014 12:30pm-1:01pm EDT

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among physicians throughout the u.s. for anyone who has fever and -- or other systems of infection, and who has been to west africa in the previous 21 days. we have established laboratory services throughout the country, so not all laboratory tests have to come to the specialized laboratory in the cdc, in fact one of those laboratories in austin, texas identified the first case here. we have fielded call from doctors and healthcare professionals throughout the country. and only one patient had ebola. but that's one too many. and we're open to ideas for what we can do to keep americans as safe as possible as long as the outbreak is continuing. we also have established emergency response teams from
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cdc that will go within hours to any hospital that has an ebola case to help them provide effective care safely. there's a lot of understandable concern about the cases in dallas. i have one slide, if we can show it, of the contact-tracing activities there, and i think we have provided copies for the members. the two core activities in dallas are to ensure that there is effective infection control and to trace contacts. here you see a time line in exactly what has happened in the indication of contacts. we have followed each of the contacts. when any become will, we immediately isolate them, so that we can break the chain of transmission. that's how you stop ebola. i can go through the details when you wish. we also are working to ensure that there's effective infection
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control there, and i can go through the details of that. in sum, cdc works 24/7 to protect americans. there are no shortcuts. everyone has to do their part. there are more than 500 hospitals in this country, and 2,500 health departments, we're there to support, with world class expertise, and there to respond to threats so we can help protect americans. and we're always open to new ideas and data because our bottom line is we're here to protect the health of americans. >> thank you. i appreciate the opportunity to speak with you this morning for a few minutes, on the roll of the national institute of allergy and infectious diseases
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in research addressing ebola virus disease. of note is that our okay tests actually started with the tragic vents of 9/11. if i could -- of 911, 2001, which were followed closely by the anthrax attacks which many of members remember against the congresses and the united states. it was actually mounted by the federal government. one of which was the research endeavor to develop ends counselor measures. out breaks of disease are just just as much of a tear onto the american and world public as a deliberate bio terror. you see on the slide a number of what we call category "a" pathogens from anthrax, botulism, plage, small box but look at the last bullet the viral hemorrhagic fevers, including bola and others. the viral them ran i can fevers are particularly difficult
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because they have a high degree of oathalness and high activity upon contact with body fluids, therapy is mainly supportive without specific interventions and we do not have a vaccine. and so what is the role of the national institute of health? if we can advance the slide. the role of the national institutes of health in the research endeavor. as you can see on the slide, we do basic and clinical research and importantly we apply and supply resources for researchers in industry and academia to advance product development. the end game of what we do are diagnostics, therapeutics and vaccines. i am sorry, could we get the slide back on the last slide? no, the previous one. there, right there. this is a multi-institutional endeavor. as you can see on the slide, the
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nih is responsible for fundamental basic research and early concept development. something that we did relatively alone because of the lack of interest on the industrial partners of making interventions. we partnered with b o.t.a. who you we'll hear from shortly with dr. robin robinson and we partnered with industry as i'll tell new a moment. ultimately in collaboration with the fda to get the approval of products. next slide. you have heard a lot about therapeutic interventions, i would just like to spend a moment talking to you about a few of them. first it's important to realize that they are all experimental. none of them have proven to be effective. so when you hear about giving a drug that has a positive effect, we do not know at this point "a," is it a positive effect or "b," is it causing harm. and that's the reason why we need to study these carefully at the same time we rapidly can make them available for the people who need them.
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the first one on the list is z-map. you have heard of it it was given to dr. brantley and nancy right bold. it looks good in animal model, still needs to be proven in hugh man. others such as the bio crisp product which is a nuclear side analogue. you have heard about the drug developed in support by the department of defense which is also being used and others that you'll hear about. these are just a few of those, again, that will be going in to clinical trials and that are actually being used in an experimental way with a companionate use with approval from the fda in certain individuals. let me turn to this slide here, which is an important one the. slides regarding a vaccine. we have been working on an ebola vaccine for a number of years, we did the original studies shown in an animal model to be quite favorable. we are right now in the phase of phase one trials that some of you may have heard of started at
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the nih on september the second. a second vaccine was started just a couple of days ago by the u.s. military in collaboration with the nih. when we finish the stage one trials namely asking is it safe and does it induce a response that you would predict would be protection t it's important to make sure that it's safe. if those perimeters are met, we will advance to a much larger trial in larger numbers of individuals to determine if it is actually effective. as well as not having a paradoxal negative effect. the reason we think this is important is that if we do not control the epidemic with pure public health measures, it is entirely conceivable that we may need a vaccine and it's important to prove that it is safe and effective. i would like to close by making an announcement to this committee because i am sure you'll hear about it soon in the press. this evening, tonight, we will be admitted to the clinical studies unit, special clinical
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studies unit at the national institute of health nina pham. otherwise known as nurse number one, she will be coming to the national institute of health where we will be supplying her with state-of-the-art care in our high-level containment facilities. thank you very much, mr. chairman. >> thank you, doctor. now i recognize dr. robinson for five minutes. we'll hear your statement. >> good afternoon, chairman murphy, chairman upton, ranking members. and other distinguished members of the subcommittee. thank you for the opportunity to speak with you today about our efforts by the government on ebola. i am dr. robin robinson a former vaccine developer in the industry and for last 10 years a public servant working on pandemic preparedness and many other bio threats. barta was prepared in 2006 as the government agency responsible for supporting advanced developments and brodeur. of novel and innovate he measures such as vaccines, therapeutic drugs, diagnostics
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and medical devices for the entire nation. barda exists to address the medical consequences of bio threats and emerging infectious diseases. it has supported man-made threats on a routine basis under project bio and responded to emerging threats. pan dekanich thousand nine and the influenza in china last year. today we are emersed in respond to go ebola which is a bio threat with a material threat issued by the department of homeland secure and i an emerging infectious disease. as you have said and my colleagues have said when it comes to ebola as a by threat skpherpblging infectious disease the best way to protect our crypt is to address the current end december anything africa. the worst on record. we transition from early development in to advanced development towards ultimate faa approval. since 2006 we have built an advanced development five line of more than 150 measures for
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threats and pandemic influenza is, seven of the products have been fda approved in the last two years, today we are transitioning several promising and ebola vaccines and therapeutic candidates from early development under nih and dod support and to advanced development and insuring that commercial manufacturing capacity for these products is available as soon as possible. barda in concert with our federal partner is uses partners to insure that we have counter measures to protect our citizens. over the past five years, barda with nih. cdc and fda and our industry partners have built a flexible and rapid responsive infrastructure to develop and manufacture medical countermeasures. as a result of the pandemic and preparedness act improved frank work has been afforded to federal and industry partners. last year we made five new vaccine candidates in record
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time for the h7n9 out breaks in canada. currently we are working with a wider array of partners including both manager and larger pharmaceutical companies, canada, u.k., western africa countries world health organizations and others to make and evaluate the safety and he efficacies of these ebola product candidates, we have established a measure to assist product developers on a daily base toys respond immediately in a public health emergency. we are using a number of our service assistance programs the clinical studies network centers for innovation of manufacturing. and our field finish manufacturing network to make these products available as soon as possible, in addition our people or site in plants to provide technical assistance and oversight to ex-pa at this time product availability. we are working with the cdc and others across the federal government with and internationally with our
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modeling to look at the ebola out break and what possible impacts i want individualses may occur. barda supports large scale production of medical countermeasures, response measures for public health and emergencies like the h1n1 pandemic and h79 outbreaks, we are assisting ebola vaccine and therapeutic manufacturers with scaled-up production. specifically we are supporting the development and manufacturing of z-map the apt body therapy at one manufacturer, expanding overall manufacturing capacity of z-map by enlisting the help of other tobacco based manufacturers. and working on alternative candidates to expand production capacity. pending the outcome off ongoing animal challenge studies bards a prepared to support additional promising therapeutic candidates that the doctor talked about to treatment ebola patients. we are working with industry to scale up manufacturing of three promising ebola candidates one of which we'll make an
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announcement today from pilot scale to commercial sales for clinical studies in africa next year. in addition we are supporting a number of other response activities including supporting the healthcare system preparedness, developing policies and guidance on patient movement, repat raise, standards of care, clinical guidance supporting the logistical aspect of deploying u.s. public health services officers on west africa and ongoing coordination and communication with national and international communities responding to the threat. finally, we face significant challenges as have been discussed in the coming weeks and months with the ebola epidemic continuing and as these medical countermeasures are manufactured and evaluated. but bottom line is that my colleagues here and our industry partners will use all of our collective capabilities here and a broad to address today's ebola epidemic and to be better prepared for future ebola outbreaks and bio-terrorism events going forward. i want to thank the committee and subcommittee for your generous and continued support over the past decade and the opportunity to testify.
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thank you. >> thank you. >> good afternoon, chairman murphy. >> if you would just please pull the microphone as close to you as possible. >> good afternoon, chairman murphy, ranking members and members of the subcommittee thank you for the to appear before you today with the action to his respond to the ebola epidemic. a tragic, global event think my clerks and i a -- my colleaguest the fda are determined to end it as quickly as possible. the need for vaccines and treatments so far whelming. fda has taken extraordinary steps to be proactive and flexible. we are leveraging our authorities and working diligently to expedite the development, manufacturing ability of safe and effective medical products for he bl a we are providing the fda's unique scientific and regulatory advice to companies to guide their submissions we are reviewing data as it is received. these actions help advance the
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development of investigational products as quickly as possible and, for example, in the case of the two vaccine vaccines that tr mentioned fda took only a few days to review applications and allow the studies to proceed. as a result of vaccine candidate being co developed began phase one clinical test on the ground september 2nd and a vaccine candidate being developed by new link genetics begins similar clinical testing on october 13th. we are supporting medical product development, including na i.d. barda and the department of defense. the fda's longstanding collaboration with the dod, fda was able to authorize the use of the ebola diagnostic test under our emergency authorization within 24 hours of request. we authorized the use of two additional diagnostic tests developed by the cdc and these tests are of course essential for an effective public health response. in addition we are supporting
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the world health organization. our scientists are providing technical advice working with patients with he bowl a i centsly participated in a consultation focused on ebola vaccines in geneva which included dozens of experts from around the world as well as from effected and neighboring countries in west africa. participants agreed that promising investigation of vaccines must be evaluated in scientifically valid clinical trials and in the most urgent manner. fda is working closely with our government colleagues and a vaccine developers to support this goal. it is important to note, though, that while we all want access to immediate therapies, to cure and prevent he bowl arc the scientific fact is that these investigation of products are in the earliest stages of development. there is tremendous hope that some of these products will help patients, but it also -- it is also possible that some may hurt
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patients and others may have little or no effect. therefore, access to investigation of products should be through clinical trials when possible. they allow us to learn about product safety and he have cass and i can provide an adequate means for access. fda is working with our nih colleagues to develop a complex i believe and innovative protocol to allow companie compd clinician to his he value multiple ebola products under a common protocol. the goal is to insure interpret table data and general rate actionable results in the most expeditious manner. it is important for the global community to know the risks and benefits of these products as soon as possible. until such trials are established, we'll continue to enable access to these products when available and requests by clinicians. we have mechanisms such as companionate use which allow access to investigation of products outside of clinical
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trials when we assess that the expected benefits outweigh the potential risks for the patients. i can tell you that every ebola patient in the u.s. has been treated with at least one investigational product. because fda -- because ebola is such a serious and often rapidly fatal disease, fda has approved such requests within a matter of a few hours and oftentimes in less than one hour. there are more than 250fda staff involved in this response. and without exception, everyone has been proactive, thoughtful and adaptive to the complex range of issue that his have emerged. we are fully committed to sustaining our deepen gauge. and aggressive activity to his support a robust response to the bola epidemic. thank you and i'll take your questions later. >> thank you. mr. wagner you are recognize today five minutes. >> thank you, chairman murphy. distinguished members of the subcommittee for the opportunity to discuss the efforts of u.s. just ups and border protection in deterring the spread of ebola
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by means of international travel. each day about 1 million travelers arrive in the united states. about 280,000 of them arrive at our international airports. cbp is responsible for securing our nations borders while securing the flow of legitimate travel and trade that is so vital our nation less economy. within this broad responsibility our priority mission remains to prevent terrorists and weapons from arriving in the united states. we also try to secure the threat of sear diseases from other country is we have had this role for over a hundred years and have guided the response to a variety of significant health threats. cbp officers assess each traveler for overt signs of illness in response to the recent ebola virus out break in west africa, cbp in close collaboration request with cdc is work to go inning their front line officers are provided information, trainin training td equipment needed to identify and response to international travelers who may pose a threat
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to public health. all cbp officers are provided guidance and training on identifying and addressing travelers with any potential illness including communicable diseases such as the ebola virus, cbp officer training includes cdc public health training which teaches officers to identify through visual observation and questioning the overt symptoms and characteristics of ill travelers. cbp also provides operational training and guidance on how to respond to travelers with potential illness including referring individual who his display signs of illness to cdc quarantine officers for secondary screening as well as training on assisting cdc with implementation of isolation and quarantine protocolses. additionally cbp provides training for key el the of blood-born pathogens exposure control plan, protections of exposure, personal protective equipment. preventative measures and procedures to follow. our field personnel have the most accurate updated information regarding the virus
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since the out break began field personnel have been provide a steady stream of guidance starting with initial information on the current out break of the beginning of april this year with numerous and regular updates since then. information sharing is critical and cbp continues to engage with health and medical authorities since january of 2011cdc's division of global migration and quarantine has station go ahead stationed aleanne a a lee liaison officer. information notice to his travelers entering the united states from guinea, liberia and sierra leone. providing travel information and instructions should he or she have a concern of possible infection. in addition to visually screening all passengers for overt signs of illness started october 11th, cbp began enhanced screening of travelers from the three effected countries entering jfk airrt and today expanded these
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enhanced efforts to dill us, chicago o'hare and atlanta newark. 94% of travelers from the effective countries enter the united states from these five airports, in coordination with cdc these targeted travelers are asked to complete a cdc questionnaire, provide contact information and, have their temperature checked. based on these enhanced screening efforts cdc quarantine officers will make a public health assess. since the additional measures went in to effect at jfk. we have conducted enhanced screening on 155 travelers identified in advance as being known to have traveled through one of these three affected countries. additional 13 travelers were identified by cbp officers as needing additional screening during the course of our standard interview process that's applied at all ports of entry. the a total of eight of these travelers have been sent to at thtertiary screening. all passengers were examined and released. officers receive training in illness recognition and response if they identify an individual believed to be ill, cbp will
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isolate the travel briefs the public in a designated area and contact a local barn teen officer along with public health authorities to help with further medical assessment. officers are trained to employ universal precautions in infection control, approached developed by cdk when they encounter individuals with overt symptoms of illness or contaminated items in examinations of baggage and cargo. when necessary, personnel take the appropriate safety measures based on the level of potential exposure. these procedures designed to minimize risk to our officers and the public have been utilized by both i agency on hia number of occasions. with positive results. cbp will continue to monitor the ebola out break, provide timely information and guidance to our field personnel, work close with our interagency partner to his develop aura don't measures as needed to deter the spread of ebola in the united states. so thank you for the opportunity to testify today. and the attention you are giving to this very important issue. i'll be happy to answer any of your questions. >> thank you. now we recognize dr. daniel
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varga chief clinical officers joining us from texas on video conference, dr. varga. >> good afternoon, chairman murphy, voir chase, ranking member and members of the committee. senior executive vice president for texas health resources. combined experience. and healthcare administration. i am truly sorry that i could not be with you in person today, the combined experience and patient practice, medical education, and healthcare administration. i am truly sorry that i could not be with you in person today. and i deeply appreciate the committee's understanding of our situation and how important it is for me to be here in dallas, during this very challenging and sensitive time. texas health, presbyterian hospital dallas is one of 13 whole i-owned acute care hospitals in the texas health resources system. we are an 898 bed hospital
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treating some of the most complicated cases in north texas in terms of -- in north texas excuse me. texas health dallas is recognized as a magnate designated facility for excellence in nursing services by the american nurses credentialing center, leading nursing credentialing program in the nation. texas health resource is his one of the largest faith-based centers, not for profit health systems in the u.s. and the largest in north texas in terms of patients served. our mission is to improve the health of the people in the communities we serve. and we care for all patients regardless of their ability to pay. we serve diverse communities and as such we provide one standard of care for all. regardless of race or country of origin. as the first hospital in the country to both diagnose and treat a patient with ebola, we are committed to using our experience to help other hospitals and healthcare providers. protect public health against
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this insidious virus. it is hard for me to put in to words how we felt when our patient homme thomas eric duncan lost his struggle with ebola on october 8th. it was devastating to the nurses, doctors, and team who tried so hard to save his life. and we keep his family in our thoughts and prayers. unfortunately, in our initial treatment with mr. duncan despite our best intentions in a highly-skilled medical team, we made mistakes. we did not correctly diagnose his symptoms as those of ebola and are deeply sorry. also in our need to report quickly we innin inadvertently t wrong information. no doubt that was concern to go a community that was concerned and confused already. and we have learned from experience as well. last weekend, nurse nina pham a member of our hospital family
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that courageously cared for mr. duncan was also diagnosed with ebola. our team is doing everything possible to help her win that fight. and on tuesday her condition was upgraded to good and as the doctor mentioned earlier, nina's care continues to evolve. i can tell that you the prayers of the entire texas health system are with her. yesterday, as has been noted, we identified second caregiver with ebola. i can also tell that you our thoughts and prayers remain with amber as well. a lot is being said about what may or may not have occurred to cause nina and amber to contract ebola. we know that they are both extremely skilled nurses, and we are using full protective measures under the cdc protocols so we don't yet know precisely how or when they were infected but it's clear there was an exposure somewhere, some time
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and we are pouring over records and observations in doing all that we can to fine the officers. you have asked about the sequence of events with regard to our preparedness for ebola and our treatment of mr. duncan. key events from our preparation time line are attached to our submitted statement but scheyer brief overview, as the ebola epidemic in africa worsened over the summer, texas health hospitals and facilities began educating our physicians, nurses and other staff on the symptoms and risk factors associated with the virus. on july 28th an infection prevention nurse specialist at texas health received the first centers for disease control and prevention health advisory about ebola virus disease and began sharing it with other texas health personnel. the healthcare advisory encouraged all healthcare providers in the u.s. to consider ebd and the diagnosis of febrile illness, in other words, a fever. in persons who had recently traveled to affected countries. the advisory was also sent to all directors of our emergency
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departments and signage was also posted in the e.d.s. on august 1st, texas health leaders, including all regional and hospital leaders, and the e.d. leaders across our system, received an e-mail directing that all hospitals have a hospital epidemiologic emergency palsy in place to address how to care for patients with ebola-like symptoms. the e-mail also drew attention to the fact that our electronic health record documentation in emergency departments included a question about travel history to be completed on every patient. attachments to the e-mail included a draft thr epidemiologic emergencies policy that specifically addressed ebd. cbc poster to be posted in the e.d. and the cdc advisory from 7:28 the guidelines of patients expected to having bola virus disease. including physicians and other frontline caregivers on
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august 1st and august 4th over the last two months the dallas county human department of health services communicated with us and plans were put in place for a possible case of he bowl a we have also providing the august 27th dallas county health department algorithm and screening questionnaire. at 10:30 p.m. on september 25th. mr. duncan present today texas health presbyterian dallas emergency department with a fever of 101. abdominal pain, dizziness, nausea and headache. symptoms that could be associated with many other illnesses. he was examined and went numerous tests over a period of four hours. during his time in the e.d. his temperature spiked 103 fahrenheit but later dropped to 101.2. he was discharged early on the morning of september 26 and we have provided a time line on the notable events of mr. duncan's initial emergency department visits. on september 28th, mr. d