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Legal View with Ashleigh Banfield

Live Coverage of Congressional Hearing Addressing Ebola

Aired October 16, 2014 - 12:30   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

DR. TOM FRIEDEN, DIRECTOR, CDC: We've established laboratory services throughout the country, so that not all laboratory tests have to come to the specialized laboratory at CDC. In fact, one of those laboratories, in Austin, Texas, identified the first case here.

We also have fielded calls from concerned doctors and public health officials throughout the country. We found more than 300 calls, and only one patient, Mr. Duncan, 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 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've provided copies for the members.

The two core activities in Dallas are to ensure that there's effective infection control and trace contacts. Here, you see a time line of exactly what has happened in the identification of contacts. We have followed each of the contacts. When any become ill, or if any become ill, 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 there is effective infection 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 5,000 hospitals in this country, there are more than 2,500 health departments at the local level. We are there to support, we're there with world-class expertise, and we're there to respond to threats so that we can help protect Americans, and we're always open to new ideas. We're always open to data because our bottom line is using the most accurate data and information to inform our actions and protect health. Thank you.

REP. TIM MURPHY, R-PA., CHAIRMAN: Thank you, Dr. Frieden.

Now I'll recognize Dr. Fauci for a five-minute summary.

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASE: Thank you, Chairman Murphy, Ranking Members Degette and also (ph) Ranking Member Waxman. You've just heard about the public health aspects of Ebola virus disease from Dr. Frieden. I appreciate the opportunity to speak with you this morning for a few minutes on the role of the National Institute of Allergy and Infectious Diseases in research addressing Ebola virus disease.

Of note, is that our activities actually started with the tragic events of 9/11. If I could -- of 9/11/2001 which were closely followed by the anthrax attacks, which many of the members remember, against the Congress of the United States and the press.

It was in that environment that a multifaceted approach towards bioterrorism was actually mounted by the Federal Government, one of which was the research endeavor to develop countermeasures. We soon became very aware that naturally occurring outbreaks of disease are just as much of a terror to the American and world public as a deliberate bioterror. You see on this slide a number of what we call Category A pathogens, from anthrax, botulism, plagues, smallpox, tularaemia.

But look at the last bullet, the viral hemorrhagic fevers, including Ebola, Marburg, Balassa (ph) and others. The viral hemorrhagic fevers are particularly difficult because they have a high degree of lethality and high infectivity 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 Institutes of Health? If we could advance the slide? The role of the National Institutes of Health in the research endeavor. As you could see on this 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 endgame of what we do are diagnostics, therapeutics, and vaccines. I'm sorry, could we get the slide back on the last slide? No, the previous one. I'm very sorry. Could we get it back? There, right there. This is a multi-institutional endeavor. As you can see on this slide, the 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 BARDA, who you'll hear from shortly, with Dr. Robin Robinson. And then we partnered with industry, as we've done in a moment, as I'll tell you, to ultimately in collaboration with the FDA, to get the approval of products.

Next slide. You've heard a lot about therapeutic interventions. I'd 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.

The first one on the list is ZMapp. You've heard of it. That was given to Dr. Brantly and Nancy Writebol. It looks very good in animal model. It still needs to be proven in the human.

There are others, such as the BioCryst product, which is a nucleoside analog. You've heard about the Tekmira drug, which was developed in support by the Department of Defense, which is also being used, and others that you'll hear about, such as Brincidofovir and Favipiravir.

These are just a few of those, again, that will be going into clinical trials and that are actually being used in an experimental way with compassionate use with approval from the FDA in certain individuals.

Let me turn to this slide here, which is an important one. Slides regarding a vaccine. We have been working on an Ebola vaccine for a number of years. He did the original studies shown in an animal model to be quite favorable. We are now right at the phase where we are in Phase I trial, that some of you may have heard of, started at the NIH in September the 2nd. A second vaccine was started just a couple of days ago by the U.S. military in collaboration with the NIH.

When we finish those Phase I trials, namely asking is it safe and does it induce a response that you would predict would be protective? It's important to make sure it is safe.

If those parameters 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 paradoxical negative deleterious 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'd like to close by making an announcement to this committee, because I'm sure you'll hear about it soon in the press. This evening, tonight, we will be admitting to the Clinical Studies Unit, the Special Clinical Studies Unit at the National Institutes Of Health Nina Pham, otherwise known as nurse number one. She will be coming to the National Institutes of Health where we'll be supplying her with the state-of-the-art care in our high-level containment facilities.

Thank you very much, Mr. Chairman.

MURPHY: Thank you, Doctor.

I now recognize Dr. Robinson for a five-minute summary of your statement.

ROBIN ROBINSON, DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, HHS OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE: Good afternoon, Chairman Murphy, Chairman Upton, Ranking Members Degette and Waxman, and other distinguished members of this subcommittee. Thank you for the opportunity to speak today about our efforts by the government on Ebola. I am Dr. Robin Robinson, a former vaccine developer in industry

and, for the last 10 years, a public servant, working on pandemic preparedness and many other biothreats.

BARDA was created by the Pandemic and All Hazards Preparedness Act in 2006. It is the government agency responsible for supporting advanced developments and procurement of novel and innovative medical countermeasures such as vaccines, therapeutic drugs, diagnostics, and medical devices for the entire nation.

BARDA exists to address the medical consequences of biothreats and emerging infectious diseases. BARDA has supported medical countermeasure development for man-made threats on a routine basis. Under Project Bioshield, we responded to emerging threats like H1N1 pandemic in 2009 and the Avian Influenza H7N9 outbreak in China last year.

Today we are immersed in responding to Ebola, which is simultaneously a biothreat with a material threat determination as issued by the Department of Homeland Security and an emerging infectious disease.

As you have said, and my colleagues have said, when it comes to Ebola as a biothreat and emerging infectious disease, the best way to protect our country is to address the current epidemic in Africa, the worst on record.

BARDA works with its federal partners to transition the medical countermeasures from early development, as Dr. Fauci said, into advanced development towards ultimate FDA approval. Since 2006 we have built an advanced development pipeline of more

than 150 medical countermeasures for chemical, biological, radiological, nuclear threats and pandemic influenza. Seven of these products have been FDA approved in the last two years.

And today we are transitioning several promising and maturing Ebola vaccines and care and therapeutic candidates from early development under NIH and DOD support into advanced development, and ensuring that commercial scale manufacturing capacity for these product candidates is available as soon as possible.

BARDA, in concert with our federal partners, utilizes public- private partnerships with industry to ensure that we have countermeasures 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 All-Hazards Preparedness Reauthorization Act, improved framework for medical countermeasure development has been afforded to federal and industry partners. And last year, we made five new vaccine candidates in record time for the H7 and 9 outbreaks in China.

Currently, we're working with a wider array of partners, including both small and large pharmaceutical companies, Canada, the U.K., Western-African countries, the World Health Organizations and others, to make and evaluate the safety and efficacies of these Ebola product candidates.

BARDA has established a medical countermeasure infrastructure to assist product developers on a daily basis to respond immediately in a public health emergency. We're using a number of our core service assistance programs. There's the Non-Clinical Studies Network, our Centers for Innovation, Advanced Development of Manufacturing, and our (inaudible) Manufacturing Network to make these products available as soon as possible.

Additionally, our staff are on-site at the manufacture, people in-plant, to provide technical assistance and oversight to expedite product availability. Additionally, we're working with CDC and others across the federal government, and internationally, with our modeling efforts to look at the Ebola outbreak as it becomes epidemic, and also what possible impacts, interventions, may occur.

BARDA supports large-scale production of medical countermeasures, response measure for public health emergencies like the H1N1 pandemic, and H7 and 9 outbreaks. Today, we are assisting Ebola vaccine and therapeutic manufacturers with scaled-up productions. Specifically, we're supporting the development and manufacture of ZMAT, Monoclonal Antibody Therapy, for clinical studies at one manufacturer, expanding overall manufacture capacity of ZMAT by enlisting the help of other tobacco plant-based manufacturers, and working on alternative Ebola monoclonal antibody candidates to expand production capacity.

Pending the outcome of ongoing animal challenge studies, BARDA is prepared to support advanced development of additional promising therapeutic candidates, that Dr. Fauci talked about, to treat Ebola patients. On the vaccine front, BARDA's working with industry partners to scale up manufacturing of three promising Ebola vaccine candidates, one of which we will make an announcement today, from pilot scale to commercial scale, for clinical studies in Africa next year.

In addition to BARDA's efforts in the Ebola response, as for supporting the number of other response activities, including supporting health care system preparedness, developing policies and guidance on patient movements, repatriations, standards of care, and clinical guidance, supporting the logistical aspect of deploying U.S. Public Health Service officers to West Africa, an 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 abroad to address today's Ebola epidemic, and to be better prepared for future Ebola outbreaks and bioterrorism 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. Thank you.

MURPHY: Thank you, Dr. Robinson. Dr. Borio, you're recognized for five minutes.

LUCIANA BORIO, ASSISTANT COMMISSIONER FOR COUNTERTERRORISM POLICY, FOOD AND DRUG ADMINISTRATION: Thank you. Good afternoon, Chairman Murphy...

MURPHY: If you'd just please pull the microphone as close to you as possible. Thank you.

BORIO: Good afternoon, Chairman Murphy, Ranking Member Degette, and members of the subcommittee. Thank you for the opportunity to appear before you today to discuss FDA's actions to respond to the Ebola epidemic, a tragic global event.

My colleagues and I at the FDA are determined to do all we can to help end it as quickly as possible. The desire and need for safe and effective vaccines and treatment is overwhelming. FDA's taken extraordinary steps to be proactive and flexible. We're leveraging our authorities and working diligently to expedite the development, manufacturing and availability of safe and effective medical products for Ebola.

We're providing FDA's unique, scientific and regulatory advice to companies to guide their submissions. We're reviewing data as it is received. These actions help advance the development and investigation of products as quickly as possible.

And for example, in the case of the two vaccines that Dr. Fauci mentioned, FDA took only a few days to review the applications, and to allow the studies to proceed. As a result, the vaccine candidate being co-developed by the NIAID and GlaxoSmithKline began phase-one clinical testing on September 2nd. And the vaccine candidate being developed by NewLink Genetics began similar clinical testing on October 13th.

We're also partnering with the U.S. government agencies that support medical product development, including NIAID, BARDA, and the Department of Defense. Because of 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, of course, are essential for an effective public health response.

In addition, we're supporting the World Health Organization. Our scientists are providing technical advice to the WHO as it works to assess the role of convalescent plasma in treating patients with Ebola.

I recently participated in a consultation focused on Ebola vaccines in Geneva, which included dozens of experts from around the world, as well as from affected 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's working closely with our government colleagues and the vaccine developers to support this goal.

It is important to note, though, that while we all want access to immediate therapies to cure or prevent Ebola, the scientific fact is that these investigational products are in the earliest stages of development. There is tremendous hope that some of these products will help patients, but it is also possible some may hurt patients, and others may have little or no effect.

Therefore, access to investigational products should be through clinical trials when possible. They allow us to learn about product safety and efficacy, and they can provide an equitable (ph) means for access. FDA's working with our NIH colleagues to develop a flexible, innovative, clinical-trial protocol to allow companies and clinicians to evaluate multiple investigational Ebola products under a common protocol.

The goal is to ensure accrual of interpretable data and generate 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 a possible. Until such trials are established, we'll continue to enable access to these products when available, and requested by clinicians.

We have mechanisms, such as compassionate use, which allow access to investigational products outside of clinical trials, when we assess that the expected benefits outweigh the potential risks for the patient. I can tell you that every Ebola patient in the U.S. has been treated with at least one investigational product.

Because FDA -- Ebola is such a serious and often rapidly-fatal (ph) disease, FDA has approved such requests within a matter of a few hours, and oftentimes in less than one hour. There are more than 250 FDA staff involved in this response. And without exception, everyone has been proactive, thoughtful, and adaptive to the complex range of issues that have emerged.

We are fully committed to sustaining our deep engagement and aggressive activities that support a robust response to the Ebola epidemic. Thank you, and I'll take your questions later.

MURPHY: Thank you, Dr. Borio. Mr. Wagner, you're recognized for five minutes.

JOHN WAGNER, ACTING ASSISTANT COMMISSIONER, CUSTOMS AND BORDER PROTECTION'S OFFICE OF FIELD OPERATIONS: Thank you, Chairman Murphy, Ranking Member Degette, and distinguished members of the subcommittee, for the opportunity to discuss the efforts of U.S. Customs and Border Protection, in deterring the spread of Ebola 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 nation's borders, while facilitating the flow of legitimate international travel and trade that is so vital to our nation's economy. Within this broad responsibility, our priority mission remains to prevent terrorists and terrorist weapons from entering the United States. However, we also play an important role in limiting the introduction, transmission and spread of serious communicable diseases from foreign countries. We've had this role for over 100 years, and in coordination with CDC, we've had modern protocols in place for well over a decade that have guided response to a variety of significant health threats.

CBP officers at all ports of entry assess each traveler for overt signs of illness. In response to the recent Ebola virus outbreak in West Africa, CBP, in close collaboration with CDC, is working to ensure that front-line officers are provided the information, training and equipment needed to identify and respond to international travelers who may pose a threat 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 individuals who display signs of illness to CDC quarantine officers for secondary screening, as well as training on assisting CDC with implementation of its isolation and quarantine protocols.

Additionally, CBP provides training for its front-line personnel by covering key elements of CBP's blood-borne pathogens exposure control plan, protections from exposure, use of personal protective equipment, other preventive measures and procedures to follow in a potential exposure incident.

We are committed to ensuring our field personnel have the most accurate updated information regarding this virus. Since the outbreak began, CBP field personnel have been provided a steady stream of guidance, starting with initial information on the current outbreak at 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 2011, CDC's division of global migration and quarantine has stationed a liaison officer at our national targeting center to provide subject matter expertise and facilitate requests for information between the two organizations.

Starting October 1st this year, CBP began providing Ebola information notices to travelers entering the United States from Guinea, Liberia, and Sierra Leon. This tear sheet provides the traveler information and instruction should he or she have a concern of possible infection.

In addition to visually screening all passengers for overt signs of illness, starting October 11th, CBP and CDC began enhanced screening of travelers from the three affected countries entering at JFK Airport. And today, we expanded these enhanced efforts at Dulles, Chicago O'Hare, Atlanta, and Newark. Approximately 94 percent of travelers from the affected countries enter the United States through 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 assessment.

Since the additional measures went into effect at JFK, CBP has conducted enhanced screening on 155 travelers who are 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. A total of eight of these travelers have been sent to tertiary screening by CDC, and it' important to note that so far all passengers were examined and released.

While CBP officers receive training and illness recognition and response, if they identify an individual believed to be ill, CBP will isolate the traveler from the public in a designated area and contact the local CDC quarantine officer, along with local public health authorities to help with further medical assessment.

CBP officers are trained to employ universal precautions, an infection control approach developed by CDC, when they encounter individuals with overt symptoms of illness or contaminated items in examinations of baggage and cargo. When necessary CBP personnel will take the appropriate safety

measures based on the level of potential exposure. These procedures designed to minimize risk to our officers and to the public have been utilized collaboratively by both agencies on a number of occasions with positive results.

CBP will continue to monitor the Ebola outbreak, provide timely information and guidance to our field personnel, work closely with our inter-agency partners to develop or adopt 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're giving to this very important issue. I'll be happy to answer any of your questions.

MURPHY: Thank you.

Now we're gonna recognize Dr. Daniel Varga, chief clinical officer from -- joining us from Texas on video conference.

Dr. Varga.

DANIEL VARGA, CHIEF CLINICAL OFFICER AND SENIOR VICE PRESIDENT, TEXAS HEALTH RESOURCES: Good afternoon, Chairman Murphy, Vice Chair Burgess, Ranking Member Degette, and members of the committee.

My name is Dr. Daniel Varga. I'm the chief clinical officer of and senior executive vice president for Texas Health Resources. I'm board certified in internal medicine and have more than 24 years of combined experience in patient practice medical education and health care administration.

I'm 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 wholly- owned acute-care hospitals in the Texas health (inaudible) system. We are an 898 bed hospital treating some of the most complicated cases in north Texas in terms of -- excuse me -- in north Texas.

Texas Health Dallas is recognized as a Magnet-designated facility for excellence in nursing services by the American Nurses Credentialing Center, the nation's leading nursing credentialing program.

Texas Health Resources is one of the largest state-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 health care providers protect public health against this insidious virus.

It is hard for me to put into words how we felt when our patient 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 of Mr. Duncan, and despite our best intentions and a highly skilled medical team, we made mistakes. We did not correctly diagnose his symptoms as those of Ebola, and we are deeply sorry.

Also, in our effort communicate to the public quickly and transparently, we inadvertently provided some information that was inaccurate and had to be corrected. No doubt, that was unsettling to a community that was already concerned and confused, and we have learned from that experience, as well.

Last weekend, Nurse Nina Pham, a member of our hospital family, who 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 Dr. Fauci mentioned earlier, Nina's care continues to evolve.

I can tell you that the prayers of the entire Texas health system are with her. Yesterday, as has been noted, we identified a second caregiver with -- with Ebola. And I can also tell you that 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 were 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, sometime. And we are poring over records and observations and doing all we can to find the answers.

You've asked about the sequence of events with regard to our preparedness for Ebola and our treatment of Mr. Duncan. Key events from our preparation timeline are attached to our submitted statement, but here's a 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 Health Care Advisory encouraged all health care providers in the U.S. to consider EVD in the diagnose of febrile illness -- in other words, a fever -- in persons who had recently traveled to affected countries. The CDC Advisory was also sent to all directors of our emergency departments, and signage was also posted in the E.D.'s.

On August first, 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 policy 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 EVD. A CDC-based poster, to be posted in the E.D., and the CDC advisory from 7/28.

The August 1 CDC guidelines and evaluation of U.S. patients suspected of having Ebola (inaudible) disease was distributed to staff, including physicians, nurses and other frontline caregivers on August 1st and August 4th.

Over the last two months, the Dallas County Health and Human Services Department communicated with us frequently as plans and preparatory work were put in place for a possible case of Ebola.

We have also provided the August 27th Dallas County Health Department Algorithm and screening questionnaire.

At 10:30 p.m., on September 25th, Mr. Duncan presented to Texas Health Presbyterian Dallas Emergency Department with a fever of 100.1. Abdominal pain, dizziness, nausea and headache -- symptoms that could be associated with many other illnesses.

He was examined and underwent numerous tests over a period of four hours. During his time in the E.D., his temperature spiked to 103 degrees Fahrenheit. It later dropped to 101.2. He was discharged early on the morning of September 26th and we

had provided a timeline on the notable events of Mr. Duncan's initial emergency department visit.

On September 28th, Mr. Duncan was transported to the hospital by ambulance. Once he arrived at the hospital, he met several of the criteria of the Ebola algorithm. At that time --