Update on H2N2 and Announcements Related to CDC's New Organizational
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
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
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
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
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
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
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
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
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
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
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
I'll take another question from the telephone.
MODERATOR: Thank you. Judy Graham with the Chicago Tribune, your line is
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
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
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
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
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
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
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
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.
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