U.S. Ebola House Hearings (Tom Frieden, Daniel Varga)

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Witnesses: Frieden, Fauci, Robin Robinson (HHS), Luciana Borio (FDA), John Wagner (Customs, Homeland Security), Varga (Texas Health Resources, by video)

Frieden: Ebola spreads only by direct contact by a patient who is sick or who has died from Ebola, or from their body fluids. We know how to control Ebola, even in this period, even in Lagos, Nigeria, we've been able to contain the outbreak by tried and true measures: identifying, isolating, tracing contacts, isolating any infected contacts. There are no shortcuts and it is not easy to control it. To protect the U.S., we have to stop it at the source. There is a lot of fear of Ebola. One of the things I fear as director of the CDC is that Ebola will spread more widely in Africa. If this happens, it could become a threat to our health system for a long time to come.

We've helped each of the affected countries establish exit screening. Recently, we've added another level of safety: screening people upon arrival in the U.S. We've also increased awareness throughout physicians to "think Ebola" in anyone who has fever/African history. We've established specialty laboratories. We've fielded calls from concerned doctors and health officials. More than 300 calls - only one patient. We're open to ideas. We've established emergency response teams.

Fauci: The NIH is pursuing experimental therapeutics. We don't know if our drugs are therapeutic or causing harm. ZMAPP - looks good in animal models, needs to be proven in humans. You've heard about the Tecmira drug and a few others that will be going into clinical trials, and approved for compassionate use in a few individuals.

Ebola vaccine: animal model has been quite favorable, Phase 1 trials started Sept. 2. A second vaccine trial was just started a few days ago. Is it safe? If those parameters are met, we'll advance to a much larger trial to determine whether it's effective and to confirm safety. We think this is important because if we cannot contain Ebola, we will need a vaccine. This evening, we will be admitting to the clinical study unit Nina Pham. We'll be providing her with state-of-the-art care.

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Re: U.S. Ebola House Hearings (Tom Frieden, Daniel Varga)

Robinson: Barda exists to respond to emerging threats. Today, we're immersed in responding to Ebola, both a biothreat and emergent disease. The best way to address these threads is to address infections in Africa. Since 2006, we've built a flexible and rapid infrastruction to obtain FDA approval for therapeutic candidates and to ensure commercialization is available as soon as possible. Last year, we made 5 vaccines in record time for H7N9 outbreaks in China. Barda can respond immediately in a public emergency to make products available as soon as possible. We're supporting the scaling up of ZMAPP manufacturing capacity. We're prepared to support additional candidates. On the vaccine front, we're working to scale up three promising candidates, one of which we'll make an announcement about today.

Borio: FDA has taken extraordinary steps to be proactive and flexible. Guiding submissions, reviewing data. In the case of the two vaccines, FDA took only a few days to review submissions. The GSK vaccine began on 9/2. the Newland Genetics began a few days ago. FDA was able to authorize the use of Ebola diagnostic test by the DoD within 24 hours of request. We're supporting the WHO in evaluating the effectiveness of convalescent plasma. While we all want access to immediate therapies, these investigative products are in the earliest stages of development. It is possible some may hurt patients or have little or no effect. Clinical trials are important. We're working on a common protocol to expedite trials.

Wagner: 280,000 travelers a day at international airports. Modern protocols for well over a decade to address health threats. CBP officers identify travelers with illness and respond with isolation/quarantine protocols. Provided information since April on Ebola. Liaison office between CBP and CDC. Information sheets provided to individuals from three impacted countries. Now doing enhanced screening at 5 airports, covering approximately 94% of travelers from these impacted areas. Since the additional measures went into effect at JFK, 155 travelers interviewed. 13 needed additional screening. 8 of these travelers were sent to tertiary screening. All passengers were examined and released.

Varga: chief clinical officer, board certified in internal medicine. I am truly sorry I can't be there in person. We care for all patients, regardless of race, origin, or their ability to care. We're committed to using our experience to help other health systems. It was devastating to the nurses and doctors when Duncan died - we keep his family in our thoughts. Despite our best intentions, we made mistakes. We did not correctly diagnose him with Ebola. Also, we inadvertently provided information that was inaccurate and had to be corrected. Last weekend, Nina Pham was also diagnosed. Our team is doing everything possible to help her win that fight. On Tuesday, her condition was upgraded to good. Yesterday, second caregiver with Ebola. A lot is being said about what may or may not have occurred that caused Nina and Amber to contract Ebola. We know they are both skilled nurses and using CDC protocols. We're doing all we can to find the answers.

As the Ebola epidemic worsened over the summer, THS began educating staff. On July 28th, infection control nurse began sharing information. CDC advisory was sent to all ED directors - signage posted in EDs. August email about epidemiology of Ebola - also drew attention to area of travel history, to be completed for every patient. CDC-based poster, advisory from 7/28. Distributed to staff on 8/1 and 8/4. Dallas health department communicated frequently. 8/28 screening questionnaire. Duncan presented with 100.1, abdominal pain, dizziness and headache. During his time in ED, spiked to 103, dropped to 102. Discharged morning of 9/26. Transported 9/28, met several of the criteria of the Ebola algerhythm. Followed all recommendations. Masks, eye protection, gloves, shoe covers added shortly after. 9/30 Ebola diagnosed - 10/1 CDC arrived on campus. We've taken all steps possible to maximize safety of staff and community. Want to be an agent of change across the health system, helping others to learn from our experience.

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Re: U.S. Ebola House Hearings (Tom Frieden, Daniel Varga)

Q. A second nurse took a flight. We were told she called the CDC and was told she could fly.

A. Frieden: I was not part of the conversation, but she did call the CDC. The protocol for movement/monitoring for potentially-exposed people identifies as high risk someone who did not wear appropriate PPE.

Q. What specifically did she tell you?

A. I have not seen the transcript. My understanding is that she reported no symptoms to us.

Q. Will people who come into travel with her (Amber) be under any travel restrictions now?

A. The people coming into contact will be in PPE; therefore, they are not restricted.

Q. Why is she being transferred?

A. Her condition has not deteriorated - we have a limited capacity of beds to do this high level of care. We have two beds at NIH.

Q. Where did this opinion that keeping travel open is important? Did someone advise you?

A. That discussion was in the context of stopping Ebola at the source.

Q. Was there actual training of personnel at THS? Where people could ask questions?

A. No.

Q. What should people have been wearing before he was diagnosed? Duncan had diarrhea and vomiting. In your testimony, people should have been completely covered, right?

A. Additional, fluid-protective covering was recommended, yes.

Q. And you told her she could get on the plane?

A. People who are in controlled movement should not board commercial airlines.

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Re: U.S. Ebola House Hearings (Tom Frieden, Daniel Varga)

Q. You can still get Ebola after 14 or 15 days. So back to these 150 people a day from West Africa. It's perfectly conceivable they can get to their destination and then get sick. The president does have the legal authority to impose a travel ban. Other countries have imposed travel bans.

A. Right now, we know who's coming in. If we limit travel, people may come in over land. We may not be able to check them for fever when they leave. Borders can be porous in this part of the world. We won't be able to take a detailed history. We wouldn't be able to impose quarantine if needed, and detailed locating information.

Q. What assurances can you give Americans it won't be a widespread epidemic? If we had a travel ban, wouldn't we just force people to hide their point of origin?

A. HCWs are are the greatest risk. We need to immediately assess people who have traveled to West Africa. We do not want to lose the trail of information we have.

Q. Medical waste: you assured me standard protocols were being followed. The waste has to be trucked, not incinerated. Is Ebola waste as contagious as a patient with Ebola? Is off-site disposal allowed?

A. The waste can be readily decontaminated. Ebola is not particularly hardy. Detailed guidelines for disposable of medical waste from Ebola patients are available.

Q. Will American troops come into contact with Ebola patients or others in controlled movement groups?

A. DoD says no contact is planned. However, there's always the possibility. We're taking temperatures among troops.

Q. Has CDC done a root cause analysis and come up with an action plan?

A. We have a team of 20+ top disease detectives in Texas. We identified three areas of focus: prompt diagnosis, contact tracing, effective isolation. We're looking very closely at what might have happened.

Q. Dr. Robinson, what are you doing to help NewLink in Ames, IA, get their vaccine to market?

A. We've provided assistance with their FDA submission, finding partners and establishing a third mfr. site.

Q. Mr. Wagner, what are the strengths/downsides of travel restriction?

A. We can identify people have been to these affected regions, but it's easier to manage when people volunteer this information.

Q. First nurse is now being transported? Are people no longer willing to stay at Texas Pres.?

A. Texas Pres. is dealing with a difficult situation, including monitoring 50 individuals who may have been exposed. We hope no more will develop Ebola, but we know it's a possibility. We felt it would be more prudent to focus on patients who may come in.

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Re: U.S. Ebola House Hearings (Tom Frieden, Daniel Varga)

Q. Here's a picture of you, Dr. Frieden, in Western Africa, with no skin exposed. It's impossible to do disinfection with skin exposed. We know 10% of cases in Africa are HCWs. What kind of stockpile of this kind of personal equipment do you have available?

A. We know from talking to manufacturers there are no shortages right now. Our goal was to get hospitals ready. The PPE to be used is not simple and there's no right answer. There's a balance between familiarity and effectiveness.

Q. Do we have the ability to train and equip in terms of nurses? We don't have a good answer as to why these nurses contracted Ebola. Was it a problem with not following the protocols? Or was there something wrong with the protocols? Two days went by when skin was exposed. Protocols said they should be wearing that protective garb, even before diagnosis.

A. Those first couple of days were before his diagnosis was known. There was some variability in the use of PPE during those days.

Q. How are we going to ensure that we do more than just trying?

A. 1) Think Ebola, 2) isolation the patient, call the CDC, and we'll talk you through what to do

Q. Dr. Varga, has your organization identified either the breach in protocol, or the inadequacy of the protocol?

A. We are investigating the source of exposure. We've confirmed Nina was wearing PPE through the whole period of time. With the confirmed diagnosis, the level of PPE was elevated to the full "hazmat" style.

Q. Dr. Frieden, do your PPE guidelines mirror international standards in West Africa?

A. The international standards evolve and change. We use different PPE in different settings. There is no single right answer. Our guidelines are consistent with recommendations from the WHO.

Q. The issue of elevated temperature...is it 100.4? 100.5, 99.6? Mr. Duncan's temperature the first time was 101. Give us some guidelines on what is elevated temperature and when should parents be concerned.

A. Parents should not be concerned. The only people with exposure to Ebola in the U.S. are those who are providing care to patients or their contacts. Screening criteria: always trying to have an additional margin of safety and check more people.

Sorry - I'm afraid I have to leave it at this point.