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Telebriefing Transcript
Update on H2N2 and Announcements Related to CDC's New Organizational Structure

April 21, 2005

DR. GERBERDING: Before I begin, I would just like to acknowledge some very special guests who are here at CDC today.

I have Pat Libbey, who's the head of NACCHO, the National Association of City and County Health Officials. George Hardy, who's the head of the Association of State and Territorial Health Officials and Dr. John Agwunobi who's the head of--or the director of health in the state of Florida.

These are very important officials in the public health network that we rely on, across government, to keep us safe, in health, but they are also friends of CDC, close counselors of our organization and good friends on a personal basis. So we're delighted they were able to join us for this press briefing.

I'm here today because the press has expressed ongoing interest in the H2N2 influenza A situation and as we committed last week, we want to be able to keep you updated on where we are with that particular health threat.

In addition, I'm going to be announcing some important changes at CDC that we thought were important to share with our public.

In terms of the H2N2 situation, we believe that at least 99 percent of all of the H2N2 influenza proficiency test kits that were distributed have been recovered and destroyed. In fact, we just got a recent update from the College of American Pathologists which was the organization responsible for most of this testing, and they're reporting that the number's even higher, about 99.6 percent from that organization.

So as you can see, a huge amount of work has gone across the laboratory network over the last several days to track each and every one of these kits down and destroy them.

We have a few stragglers and we're of course working, and will continue to work until we have accounted for every single one of these proficiency tests.

It's also important to acknowledge that no human case of H2N2 has been identified anywhere in the world, so the threat to laboratory workers, or to the public, continues to be low in our very best ability to measure that.

As we've said all along, while we believe the threat was low, we aren't taking any chances, and we will continue to address this problem now, and we're also taking steps to understand it and prevent it from happening in the future.

Along those lines, we did receive samples from the Canadian laboratory as well as from Meridian Bioscience, and we were able to confirm that the H2N2 isolate that was identified in Canada is identical to the isolate that is in the proficiency test kit, so this does of course confirm that the test kit was the likely source of that virus in Canada.

Secretary Leavitt has asked CDC and CMS to convene experts from across the laboratory community to really evaluate what happened, that caused this decision to be reached, to distribute these test kits, and to investigate all of the steps in the process that may be amenable to intervention and prevention in the future.

So we are doing that, the team has been assembled, we've included experts from our agency, from Centers For Medicare/Medicaid Service, as well as the experts from the American Public Health--the Association of Public Health Laboratories, and others with specific expertise in proficiency testing and they are assembled. They are working on this investigation as we speak.

In addition, NIH and CDC together will be posting new recommendations on including these type of H2N2 influenza strains in biosafety level 3 containment facilities in the future.

Right now, we use safety level 2, and obviously that is a very important and stringent safety level, but we think that any isolate that has the potential to cause a pandemic influenza threat really should be cared for with an extra margin of safety. So we will be announcing those recommendations next week on the Internet and then distribute them beyond that point.

We are also initiating the guidance for new recommendations around proficiency testing. This will cover, in addition to just what is tested, where it's tested, how it's tested, and what kind of safety precautions are essential in testing.

We're doing this because proficiency testing is important. It is essential that our laboratories know that they can perform the kinds of tests accurately that we need to be able to identify emerging health threats and the only way to do this is to ask them to undergo this kind of self-testing, to be sure that they really do have the capability to do their job.

So we are going to be continuing with proficiency testing in this country but we can do it safer and we will make every effort to assure that proficiency testing does follow all common sense precautions, as well as those that we, as scientists, feel are essential for protecting laboratory workers and the public.

The last step that will be undertaken is a review to determine whether or not these kinds of pandemic potential viruses should be handled like other select agents that could be agents of bioterrorism.

This is a process that has begun and we will be doing a fast assessment to determine the pros and cons of including these agents in the select agent list, and that story will unfold over the next several weeks, not days, so we'll again update you as decisions are reached and the experts develop the consensus around the appropriate strategies.

So with respect to H2N2, I think it's very important to think about it in the context of a number of threats that we've been experiencing in the last several years--SARS, monkeypox, avian influenza. These are threats that are urgent; they're threats that could affect the health of a large number of people. They're threats that often are global in origin, sometimes ultimately originating in animals.

But they are also threats that require CDC and our partners in the local and state health departments to act quickly, to act collaboratively as an efficient network, and they're threats that really require us to cross disciplines.

It isn't enough to have laboratory scientists engaged in these. We need laboratory scientists, we need epidemiologists, we need experts in biosafety, we need communications experts, we need informaticians, we need geneticists, we need a whole cadre of disciplines that certainly cut across the organizational boundaries at CDC, but increasingly cut across the organizational boundaries of our partner agencies, of the academic community, the private sector, the health care delivery sector, the business community, and so on and so forth.

Another, I think, very important aspect of these threats is that effective communication, not just to the public, but effective communication across all the parts of the network is absolutely critical to succeed.

Now CDC took a hard look at these threats that are urgently facing us, and there have been many of them in the last few years.

We've also recognized the growing threat from the important health problems that people face every day, things like cardiovascular disease and cancer and obesity and tobacco.

These threats often come in the context of health disparities, where people are disproportionately affected, but they're also coming at a time in our society and in our world where we have new opportunities, new technologies, new ways of identifying and responding to threats.

And as an agency, we've taken a hard look at these challenges as well as these opportunities, and we recognized, a year and a half or so ago, that we really did need to adjust.

We needed to be a 21st Century health agency that could respond to these 21st Century threats, and so we did initiate our change initiative.

The context of this is remarkable, I think. CDC last initiated a major organizational change more than a quarter of a century ago.

At that time our organization had about 4,000 employees and a budget of about $300 million. Today, we have an organization of about 15,000 workers and a budget of about $8 billion.

So in the 25 years where we've grown by at least a log, the world really has changed, and our employees and our partners also took a look at these changes.

And after thousands of conversations and probably thousands of meetings, we really did commit to the fact that we wanted to modernize CDC and make sure that we were able to continue to do our job and continue to have the best science and the best service in this century that we possibly could.

Secretary Leavitt, the administration and the Congress have supported these changes, and as Secretary Leavitt said, this is really bold and significant change. We're not talking about incremental changes. So I'm really pleased to announce today that Congress has formally approved our proposed restructuring proposal. The proposal was forwarded to Congress by Secretary Leavitt 15 business days ago and they concur with our structure to support the necessary changes at CDC.

This is a very, very important day in the history of this organization, because it means that we are changing the way we look and we are doing that to support the changes in the way we work.

I think what you'll see in the new CDC is an agency that really does bring experts together effectively, across organizational (lines), an agency that will reduce the duplication of some of its support services, so that we can use those saving to reinvest in our science and program, an agency that has a much stronger focus on communication effectively within CDC but also outside of CDC.

And we are going to be even more conscientious and more focused on supporting our workforce, not just within CDC but the workforce of the whole public health system, which we all know is the workforce that is jeopardized by a lack of career development and lack of incentives and motivations to enter for young people.

So we've got our work today, and I'm pleased Dr. Thacker is here today, because he is the person at CDC who's taking on the new Office of Workforce and Career Development, to help lead this process, and to assure that the CDC workforce remains our greatest asset, but also we do our job of helping provide similar services for the whole public health services.

So what can you expect from the new CDC? The most important thing is you can expect us to be able to clearly articulate what our priorities are and measure our progress in achieving them.

We intend to have a measurable impact on health and we intend for everyone to see what that impact is intended to be and whether or not we're making progress in achieving it.

And I think you'll be able to see even better science out of this agency and we've already had some terrific examples which I'll mention in a second. But we intend to emphasize the cross-discipline science and the innovations that can occur when you bring clever people together to solve complicated problems like the 21st Century health problems that I mentioned.

I think you can see stronger partners. That's why I'm so pleased that the special guests are here today, because we are committing our role to the public health network as being an effective partner, a listening partner, a learning partner, and a partner that does our job in concert with the jobs that folks in the local and state health agencies are doing together.

We are the backbone of the health system and our job is easier to do when we do it as an effective network than we do it as independent or individual agencies, and we learned that with the flu vaccine shortage this year, where, because we were able to work as a network, we achieved a remarkable improvement in vaccine coverage compared to what we expected when the flu season begins.

You can also expect that there'll be some new faces at CDC. As part of the formal approval of the reorganization, I'm able to formally announce that Dr. Henry Falk is now the official director of the Coordinating Center for Environmental Health and Injury Prevention, and Henry Falk is here today.

Dr. Donna Stroup is the director of the Coordinating Center for Health Promotion. She's not able to be here today.

And Dr. Mitchell Cohen is the director of the Coordinating Center for Infectious Diseases. Dr. Cohen.

In addition, our recruitment for the center directors that are in the acting role now is in full force and we will be able to complete those appointments.

We have more than 330 extraordinary scientists who have applied for center director positions at CDC. So the pipeline of interest and the leadership of these vital organizations is strong and it's very exciting. I've had a chance to see and talk to some of the candidates and it's just a wonderful opportunity for CDC to evolve even further.

We've been busy while all this is going on and I can't resist the temptation to brag a little bit about some of our successes.

I've mentioned the public health system's response to flu this year.

I'd like to also mention that our Laboratory Response Network has been nominated as a finalist with the Innovation in Government Award, competing against thousands of other government projects.

The Laboratory Response Network are 140 laboratories around the country and the world, that work together as a frontline of defense against emerging laboratory threats, infectious diseases like SARS and monkeypox and avian influenza and so forth.

We've also innovated within CDC. We have gotten permission from Congress to have a special learning account, so that our employees are guaranteed an opportunity to train. We've initiated some management efficiencies that have allowed us to save $86 million that normally would go for administration and management and take that money back to divisions for programs and scientific research that will directly affect health.

And lastly, for those who are here, you will notice when you leave the building, that there are four very large laboratories that are coming online here at CDC, three on this campus and one on the Chamblee campus in Atlanta.

This is a very, very important step to the future of CDC because these laboratories provide, for the first time ever, world-class laboratories for world-class scientists to really do their very important public health work, and we thank our CDC Foundation, Charlie Stokes and his team, as well as the Friends of CDC, who have worked hard to assure that these laboratories do develop and serve their function in support of our agency.

So let me end with just a thank you to you for your ongoing interest in CDC and public health issues, but also to the public for their interest and their support of the work that goes on at CDC and across the Department of Health and Human Services.

We're here to serve the public, we are a service agency, and we believe that changes that we're making will help us do an even better job to protect the health and safety of Americans and people around the world. Thank you. I'll be happy to take some questions.

QUESTION: Hi, Dr. Gerberding. Betsy McKay from The Wall Street Journal. I have just one question about health marketing, which I know is an important part of the organization. I'm afraid I don't have the budget in front of me but everyone knows there are budgetary constraints, and I'm wondering, with all the pressures that public health faces in terms of funding, what your plans are, you know, how you'll fund this important new part of CDC?

DR. GERBERDING: Thank you. The new National Center of Health Marketing is intended to be a science institution that provides the research as well as the programs related to marketing the information people need to make choices about their health status.

We are starting by a combination of some older parts of CDC and reconfiguring, for example, the division responsible for our public health training network, and our television capabilities as part of the new center, we're moving pieces of different components together for this and we will be of course using the budgets that used to go to the old organizations to support the new one.

We also have achieved some financial flexibilities because Congress restructured our budget in support of our change at CDC, and we'll be making decisions about how we will use these flexible dollars.

We need to fund some new projects related to our goals and we need to support our two new centers effectively.

We also received, this year, a large amount of money, $8 million, for extramural research and we made the decision to target those dollars this year to support research related to communication and health marketing, to jump-start the science that these centers are going to need, and we know that there are wonderful academicians out there who can do this kind of work and really help us get started down the road of having a science-based communication strategy for our agency.

The next question; maybe from the phone.

MODERATOR: Thank you, Dr. Gerberding. Kwame Foucher, your line is open, with ABC News Medical Unit.

QUESTION: Yes. I had a question going back to the H2N2. How often will the laboratories be doing testing and will the frequency change?

And the second part of the question is will there be improvements in next year's flu vaccine distribution network, matching the timing with the need?

DR. GERBERDING: Thank you. I'll take the first part of your question. The proficiency testing is done on a routine basis using a wide variety of organisms, sometimes bacteria, sometimes viruses, sometimes other agents, and it is an ongoing and continuing process that happens at periodic intervals.

The program is administered by the Center for Medicare and Medicaid Services. There are organizations like the College of American Pathologists who are responsible for assessing the proficiency of labs, so they actually conduct this testing, and they have a variety of rhythms and a variety of schedules that they use.

But the bottom line is, yes, this will continue, thankfully, because as I said, we really need this proficiency testing to be ongoing.

With respect to the anticipated distribution of flu vaccine in the next season, we are optimistic about the reports that we've heard from the flu manufacturers, but as we heard last year, we can't count on flu vaccine until it's in the arms of the people who need it the most, and so we are approaching this year's season with a very consistent ongoing communication with all of the vaccine manufacturers so that we can be right on top of any development that would affect the supply.

We're planning for several scenarios. A most vaccine ever scenario, about the same vaccine as we normally have scenario, and a vaccine shortage scenario such as we had last year, so that we will be able to target our distribution under all of those scenarios to get vaccine into the arms of the people who are in the highest priority risk groups.

That planning is going on in conjunction with the very people who are sitting in this room and we're all working together to make sure we have a consistent strategy before flu season arrives and I think we're well on our way toward that.

I'll also say that Secretary Leavitt has made flu, in particular avian flu, as well as pandemic flu planning, one of the highest priorities of the first part of his administration.

We're still meeting on a daily basis, to be updated on the avian flu situation and other emerging issues.

So we are well out in front of this issue this year and we will continue to make it one of our highest priorities, across government.

I'll take another telephone question.

MODERATOR: Thank you. Paul Shin with the New York Daily News, your line is now open.

QUESTION: Thank you for taking my call, Dr. Gerberding. I understand that CDC is not the regulatory agency but is this a mistake that could result in any regulatory penalties for Meridian Bioscience regarding the H2N2?

DR. GERBERDING: You're absolutely right. CDC is not a regulatory agency and we're just at the beginning of the investigation of the steps that led to the decisions and distribution of these test kits. So I'm not going to speculate about what if any official sanctions could be in store.

I think the important thing right now is that we have an open mind and look to the whole process to make sure that we understand exactly what happened here.

I'll take another question from the telephone.

MODERATOR: Thank you. Judy Graham with the Chicago Tribune, your line is now open.

QUESTION: Is the CDC planning on doing any kind of inventory of which facilities have what kind of flu strains as part of the investigation?

DR. GERBERDING: In terms of the H2N2 investigation, we have reliable information about the distribution of these proficiency test kits because they went out from organizations that had those records. So we're going there first.

But as our state and local health partners will tell us, we didn't stop there and we've been working with the Association of Public Health Labs and with health officials, across the world, literally, to be sure that labs that could have the proficiency tests but aren't on the lists are also contacted and notified, and we're casting a very broad net here.

So I think we'll know the answer to your question as this investigation comes to conclusion.

Any other telephone questions? Or questions in the room?

QUESTION: You mentioned that there are a few stragglers. Can you say like where these stragglers are as far as the kits?

DR. GERBERDING: Well, if I knew where the stragglers were, they probably wouldn't be stragglers. I would say that there are a few laboratories that had changes in telephone numbers. One laboratory I know has closed and it's not clear who's in charge of checking back to make sure that that proficiency test kit has been accounted for.

So there's some exceptional situations that are still in play. You know, we're probably going to be reluctant to say quickly, it's a 100 percent, because, you know, as we continue this investigation we may discover a lab, here or there, that still has the virus.

We're very relieved that this has not resulted in any detectable threat to laboratory workers or the public, and that monitoring will continue as we go forward in the next many months.

In fact the monitoring of flu vaccine strains is an ongoing process at CDC, so should there be an emergence of an H2 down the road, we would be able to detect it through our surveillance network and that will always be a priority for us.

Any other question in the room? Then I'll take a phone question.

MODERATOR: Thank you. Rolf Rosenkrantz with Inside Washington Publishing, your line is now open.

QUESTION: Hi. Dr. Gerberding, related to organizational structure, will there be any more changes to NIOSH, apart from the ones already made? And how do you plan to convince opponents of these changes, especially when it comes to funding and oversight, that those changes will actually work and increase worker safety?

DR. GERBERDING: Well, I think there actually have not been changes to NIOSH. Congress made very clear that the NIOSH stakeholders created a very powerful argument that NIOSH was doing just fine the way it was and they have instructed us not to engage NIOSH in any of the coordinating center functions that we've developed at CDC.

So we are going to continue to support NIOSH. The NIOSH director is a direct report included on the organizational chart here over the far right-hand corner, as one of the people who has contact with me, and we will continue to support the extraordinary work that NIOSH does.

I've had a chance to visit every single NIOSH facility in this country and I can tell you that I wish everyone could go and visit, because the work is extraordinary, it's wonderful science, and the scientists at NIOSH have been collaborating and working together with Injury (Center) and with the environmental health sciences, and are some of the first to step up to the plate when we have an emergency.

So I think that agency-level collaboration will continue.

I'll take another question from the telephone, please.

MODERATOR: Thank you. Katrina Woznicki from MedPage Today, your line is now open.

QUESTION: Hi, Dr. Gerberding, thank you for taking my call. I was wondering, you said earlier, you're just at the beginning of the investigation. But has Meridian communicated to you any reasons why the H2N2 virus ended up in these kits in the first place?

DR. GERBERDING: I can't answer that question today but we will know the answer to that question as the investigation proceeds. So we'll have to update you on that when we have the complete report.

Next question from the phone, please.

MODERATOR: Thank you. Greg Paeth with Cincinnati Post, your line is now open.

QUESTION: Yes. I was just wondering if the specimens that went out, or at least the one that you were able to retrieve from Canada, was it ever determined whether or not this strain was--the specimen was strong enough to actually infect someone, or was it attenuated to a point where a lab worker, anyone else who came in contact with it, would not have been infected?

DR. GERBERDING: Thank you for that question. The short answer is we don't know whether the strain involved in the test kits would have been able to infect people or not, but we've had to assume that it could.

The reason we are suspicious that it might not have been a strong strain, as you said, is because it is a strain that is known as a reference strain, that means it's been passed in the laboratory when pandemic Asian flu was present. In those days, the only way to keep a virus growing was to pass it in eggs, and so the repeated passage in eggs in the laboratory usually results in flu strains that are better adapted to causing flu in eggs than in people.

And so what that really means is the virus adapts to avian tissues and is less infectious in people.

But we don't have an easy way of knowing that, short of inoculating people with this virus and we're certainly not going to do that. The animal models that we sometimes use to study flu viruses would not give us this particular answer.

So as I said, we're just going to err on the side of caution and assume that we need to treat this as if it were an important potential threat, even if our speculation is that it might not be.

I'll also mention that this virus is H2N2 and while we haven't seen H2 in flu since 1968 in this country, N2 has been present in other virus strains. So there's possibly some protection from people who had modern strains of flu virus that would offer a little bit of cross-immunity. But, again, we're not assuming that. We have to err on the side of caution.

Is there one more question in the room?

QUESTION: Mike Toner with the Atlanta Journal and Constitution. Could you tell us, of the 96.6 percent of kits that have been recovered, where they're being held and are they being held under BSL 3 conditions now?

DR. GERBERDING: That's a very good point. It's 99.6 percent that the College of American Pathologists was reporting today. The kits are not being held. They are being destroyed and they are being destroyed using methods that we would normally use to completely eradicate any threat to human beings.

So in addition to a process called autoclaving, be incinerated and handled as medical waste, so that the threat is eliminated, and I think that's what the certification process is all about.

When we identify that a lab has one of these proficiency kits, it's the lab's responsibility to notify the originator that they've destroyed the sample and there's a certification letter that is included in that process.

One of the reasons it's taken us a while to get the whole number is because somebody's got to sit, by hand, and read through these certification letters and documents, that it matches to the lab that we sent it to.

QUESTION: So they're not actually being returned, they're being destroyed in the place that--

DR. GERBERDING: They're being destroyed using appropriate precautions.

One last telephone question, please.

MODERATOR: Thank you. Tom Maugh with the Los Angeles Times, your line is now open.

QUESTION: Can you give us a rough count for how many kits are outstanding?

DR. GERBERDING: You know, I probably--a few, based on our calculus of the number of labs that we think had the samples. You know, a couple dozen maybe, somewhere in that vicinity, but again, because there's always some uncertainty of recordkeeping, we can't give you an exact number until we have done the comprehensive investigation and we have ascertained each and every one of these organizations that do this, has fully accounted for all of their test kits.

Thank you very much for your attention, I appreciate you being here, and I thank my special guests. Thanks.

MODERATOR: Thank you. This does conclude today's conference call. We thank you for your participation.

Listen to the telebriefing

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