[Senate Hearing 107-845]
[From the U.S. Government Printing Office]
S. Hrg. 107-845
RESPONDING TO THE PUBLIC HEALTH THREAT OF WEST NILE VIRUS
OVERSIGHT OF GOVERNMENT MANAGEMENT,
RESTRUCTURING, AND THE DISTRICT OF COLUMBIA
UNITED STATES SENATE
HEALTH, EDUCATION, LABOR,
ONE HUNDRED SEVENTH CONGRESS
SEPTEMBER 24, 2002
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COMMITTEE ON GOVERNMENTAL AFFAIRS
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan FRED THOMPSON, Tennessee
DANIEL K. AKAKA, Hawaii TED STEVENS, Alaska
RICHARD J. DURBIN, Illinois SUSAN M. COLLINS, Maine
ROBERT G. TORRICELLI, New Jersey GEORGE V. VOINOVICH, Ohio
MAX CLELAND, Georgia THAD COCHRAN, Mississippi
THOMAS R. CARPER, Delaware ROBERT F. BENNETT, Utah
JEAN CARNAHAN, Missouri JIM BUNNING, Kentucky
MARK DAYTON, Minnesota PETER G. FITZGERALD, Illinois
Joyce A. Rechtschaffen, Staff Director and Counsel
Richard A. Hertling, Minority Staff Director
Darla D. Cassell, Chief Clerk
OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF
RICHARD J. DURBIN, Illinois, Chairman
DANIEL K. AKAKA, Hawaii GEORGE V. VOINOVICH, Ohio
ROBERT G. TORRICELLI, New Jersey TED STEVENS, Alaska
THOMAS R. CARPER, Delaware SUSAN M. COLLINS, Maine
JEAN CARNAHAN, Missouri THAD COCHRAN, Mississippi
MARK DAYTON, Minnesota PETER G. FITZGERALD, Illinois
Marianne Clifford Upton, Staff Director and Chief Counsel
Melanie Leitner, Congressional Fellow, Senator Durbin
Andrew Richardson, Minority Staff Director
Theresa Prych, Minority Legislative Aide
Brian McLaughlin, Staff Assistant
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut JUDD GREGG, New Hampshire
TOM HARKIN, Iowa BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington PAT ROBERTS, Kansas
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York MIKE DeWINE, Ohio
J. Michael Myers, Staff Director and Chief Counsel
Townsend Lange McNitt, Minority Staff Director
C O N T E N T S
Senator Durbin............................................... 1
Senator Kennedy.............................................. 2
Senator Gregg................................................ 4
Senator Dodd................................................. 5
Senator Frist................................................ 14
Senator Landrieu............................................. 14
Senator Warner............................................... 15
Senator Hutchinson........................................... 24
Senator Clinton.............................................. 53
Tuesday, September 24, 2002
Julie Louise Gerberding, M.D., M.P.H., Director, Centers for
Disease Control and Prevention, U.S. Department of Health and
Human Services................................................. 7
Anthony Fauci, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, U.S.
Department of Health and Human Services........................ 9
Jesse L. Goodman, M.D., M.P.H., Deputy Director, Center for
Biologics Evaluation and Research, Food and Drug
Administration, U.S. Department of Health and Human Services... 11
Sidney Andrew Houff, M.D., Ph.D., Professor and Chairman,
Department of Neurology, and Director, Neuroscience and Aging
Institute, Loyola University Medical Center, Maywood, Illinois. 33
John R. Lumpkin, M.D., Director, Illinois Department of Public
Health, Springfield, Illinois.................................. 35
Nickie Monica, Parish President, St. John the Baptist Parish,
LaPlace, Louisiana............................................. 37
Fay W. Boozman, M.D., M.P.H., Director, Arkansas Department of
Alphabetical List of Witnesses
Boozman, Fay W., M.D., M.P.H.:
Prepared statement........................................... 70
Fauci, Anthony, M.D.:
Prepared statement........................................... 57
Gerberding, Julie Louise, M.D., M.P.H.:
Prepared statement........................................... 53
Goodman, Jesse L., M.D., M.P.H.:
Prepared statement........................................... 60
Houff, Sidney Andrew, M.D., Ph.D.:
Prepared statement........................................... 64
Lumpkin, John R., M.D.:
Prepared statement........................................... 67
Prepared statement........................................... 69
John Barr, V.I. Technologies, Inc. (Vitex), prepared statement... 73
Letter from Sara C. Yerkes, Vice President of Public Policy,
International Code Council, to Senator Kennedy, dated September
26, 2002....................................................... 75
RESPONDING TO THE PUBLIC HEALTH THREAT OF WEST NILE VIRUS
TUESDAY, SEPTEMBER 24, 2002
Subcommittee on Oversight of Government Management,
Restructuring, and the District of Columbia, of
the Committee on Governmental Affairs, and the
Committee on Health, Education, Labor, and
The Committees met jointly, pursuant to notice, at 9:43
a.m., in room SD-342, Dirksen Senate Office Building, Hon.
Richard Durbin, Chairman of the Subcommittee, presiding.
Present: Senators Durbin, Kennedy, Dodd, Landrieu, Carper,
Reed, Gregg, Frist, Warner, Hutchinson, and Fitzgerald.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Good morning. The hearing will come to
order. I want to thank my colleague, Senator Kennedy, for
joining me. This is a joint hearing between our two Committees,
from the Governmental Affairs Committee, which tries to help
coordinate the agencies of government, and, of course, Senator
Kennedy is Chairman of the Committee on Health, Education,
Labor, and Pensions. It is a joint hearing on responding to the
public health threat of the West Nile Virus.
What we have learned this summer is that mosquitoes can do
more than ruin a backyard barbecue. For some Americans,
particularly the elderly and medically vulnerable, that
harmless mosquito bite can turn out to be life threatening. The
numbers of American victims of West Nile Virus have not reached
a level to rival major public health threats like influenza or
measles, but the trend line is not encouraging.
Last year, there were 66 infections across America and 9
deaths from West Nile Virus as they were reported. This year,
1,963 infections have been reported. The death toll has reached
94. This morning, 2 more deaths were reported in my home State
of Illinois, which has reached a total of 27, and for
inexplicable reasons leads the Nation. In 1 year, the West Nile
Virus infection rate is up almost 2,000 percent and fatalities
over 1,000 percent.
The source of the virus could be in backyards and parks
across America, despite the best efforts of the public health
community. Particularly worrisome are the latest reports from
Federal agencies that the virus can survive in the bloodstream
and is likely then transmitted by organ donations and blood
Today's hearing is the first in the Senate since the West
Nile Virus truly became a national challenge. We will ask the
experts in public health from Washington and across the Nation
to give us an honest and accurate appraisal of this public
health threat. We will ask the experts who monitor our Nation's
blood supply what more we can do to guarantee its safety. We
will learn the steps that are being taken to develop a vaccine
to protect us. And most importantly, we will call on public
health leaders from every level to develop a national strategy
to reverse the trend of West Nile infection and mortality.
We had hoped for a break in the battle against West Nile
Virus as the mosquito season winds down in most places across
America, but the threats to our blood supply tell us this
dangerous legacy may, and I underline ``may,'' now threaten us
year-round. The experts will tell us exactly what the threat
We owe it to the families across our Nation to redouble our
efforts to protect our Nation's blood supply and to prepare for
the battle which awaits us again next year. Our two panels of
witnesses will spell out the challenge and share with us their
views on meeting it.
I would now like to turn to my colleague, Senator Kennedy,
and ask him for his opening statement.
OPENING STATEMENT OF SENATOR KENNEDY
Senator Kennedy. Thank you, Senator Durbin. I want to thank
you very much for having this joint Committee hearing with us.
Senator Durbin has been a real leader on this issue, which is
of such enormous concern to families across this country and we
welcome a chance to join with you today in helping us all, not
only in the Congress, the American people, better understand
the nature of the challenge that we are facing, as well as the
kind of response that we are having and what more we can do to
provide help and assistance to families across this country,
and also to anticipate future kinds of challenges that are
similar, as well, whether it's going to be in the food supply,
where we're importing a great deal more, or other areas, as
So this hearing is very important, and I know Senator
Durbin feels strongly and join with Senator Dodd that this is
not just a hearing, it is the beginning of a very careful
oversight, working with the administration where we can, trying
to point up areas in which we need to make further progress.
Also, as I understand, we will be joined by Senator Breaux
and Senator Landrieu of Louisiana, a State that has been
particularly hard hit by the grim disease.
The goal of our hearing is to determine whether all
necessary steps are being taken by Federal, State, and local
governments to assist communities afflicted by the West Nile
fever. Millions of Americans have now become aware that the
West Nile fever can cause sickness and death. Recent reports
show that the disease can cause symptoms similar to those of
polio and can imperil the safety of the blood supply. That is
an enormously important issue. We want to hear from our leaders
to better understand and to guide us on the policies. We have
important questions about the blood supply and its safety. We
want to hear from our witnesses on this issue.
In a few short weeks, the virus has spread from the
Atlantic to the Pacific, from border to border. Congress should
do all it can to protect the American people from this emerging
health threat. We should provide the adequate funding for
public health measures to contain and reduce the spread of the
disease. We should expedite the development of vaccine through
new investments in research.
Threats to our Nation come in many forms. In the war
against disease, the battlegrounds will be our Nation's
emergency rooms and the heroes will be our Nation's health care
professionals. To win this war, we need to restore the funding
for hospitals, invest in the training of doctors and nurses,
and to rebuild our public health capacity. The price of victory
may be high, but the cost of defeat is higher still.
The newspapers even yesterday were pointing out the very
great amount of pressure that is on the government, the
pressures that are on our hospitals, and about the crowding. On
the front page of the Washington Post yesterday, we are talking
about the crowding in the hospitals, crowding in the emergency
room, crowding in the operating rooms. We have the stories in
our national newspapers now where we are having further
proposal by the administration of cuts in the support of our
health care systems. The hospitals are the first line of
defense, the public health system in order to detect it, and
then the hospitals to contain it, and we know about the serious
cutbacks that the administration is involved in now.
So we have all got an important responsibility if we are
talking about trying to deal with this, to make sure that we
are going to give the support to the hospitals and to the
professional personnel that are so necessary to deal with this
In the bioterrorism legislation enacted into law earlier
this year, we have begun to make some of the investments
necessary to protect against deadly diseases. These investments
are needed more than ever to prevent the spread of West Nile
fever. In fact, our public health infrastructure had
deteriorated so significantly that the initial diagnosis of
disease was needlessly delayed. We are going to need a strong
public health system if we are going to meet our
responsibilities to the Nation's people on the whole issue on
bioterrorism, as well as the kind of challenge that we are
facing with West Nile.
Unfortunately, the administration's budget steps back when
it comes to protecting the public health. While purporting to
provide more funding to hospitals to strengthen public health
and combat bioterrorism, the President's budget actually cuts
funding to America's hospitals. We cannot afford to keep
Americans well and protect the public health if the
administration will not do its part.
We have already seen what can be accomplished through
resolute action to meet a public health challenge. Within the
last year, funds and leadership provided by Congress, working
in partnership with the administration, produced an effective
national response to smallpox, and I am proud that a
Massachusetts company is leading the way in producing a new and
safer vaccine for the dread disease. We should show the same
resolve in responding to the threat of West Nile.
A few years ago, few Americans other than the specialists
in exotic diseases had even heard of West Nile Virus. Today, it
is a disease familiar to households across the Nation. The
virus was first detected in New York in 1999. In the next 2
years, the disease caused 18 deaths, 131 illnesses. This year
alone, over 1,900 people across the United States have become
ill and 94 have died. In just the last month, the number of
cases has nearly doubled. Senior citizens in South Boston and
senior citizens in Weymouth have died. This month,
Massachusetts identified its first child case of West Nile,
something the State had never, never seen before.
We need to determine whether the steps now being taken by
the Centers for Disease Control are adequate to halt the spread
of this disease and minimize the severity of the illness it
causes. Basic public health precautions, such as using insect
repellents, and eliminating standing water near homes can
reduce infections. CDC is working with local communities to
provide public health information about proper precautions, but
infection rates continue to rise. Clearly, we must do more.
We also need to determine whether the FDA and the other
public health agencies are taking proper steps to protect the
safety of the blood supply and transplanted organs and whether
NIH is developing the new vaccines, therapies, and diagnostic
tests as rapidly as possible to prevent infection and to
protect the health of those affected by West Nile.
As significant as the threat of West Nile fever itself is
today, it may also be a sign of even more deadly outbreaks in
the years to come. In this era of global jet travel, it is
possible to have breakfast in a country half a world away and
arrive in the United States for dinner. We also import millions
of tons of food from around the world. Whether released
deliberately by a terrorist, like the lethal anthrax attacks of
last year--I draw a distinction. Whether we are facing the
possibility of a terrorist, or the kind of a lethal anthrax
attacks of last year, or brought to our country accidentally,
deadly infections will threaten our health security for many
years to come.
Our hearing today will consider how we are responding to
the West Nile fever today and also how we respond to other
deadly disease outbreaks in the years to come. I thank Senator
Durbin for Co-Chairing this joint hearing and look forward to
I especially want to welcome Julie Gerberding. This will be
her first appearance in the Senate with assuming her new
responsibilities in a long and distinguished career. So we very
much welcome her as well as the other witnesses, and I thank
Senator Durbin. Thank you, Senator Kennedy. Senator Gregg.
OPENING STATEMENT OF SENATOR GREGG
Senator Gregg. Thank you, Senator Durbin and Senator
Kennedy, for holding this hearing on the West Nile Virus issue,
which is an issue that is of immediate and significant
importance to many of us, especially on the East Coast and as
it moves toward the West Coast.
We have had, as Senator Kennedy has mentioned, a large
expansion of this virus. We are now seeing it in my State.
Senator Kennedy mentioned the unfortunate deaths in
Massachusetts. We are seeing in my State the death of the bird
population, which is clearly tied to the West Nile Virus
infection, and the fact that that could be transmitted to
humans in Northern New England. It has already caused, I
believe, close to 94 deaths in our country and there have been
1,700 human cases of West Nile, in the country, and so we need
to address the issue.
Some of the concerns have been outlined by Senator Kennedy.
I think my concerns go to a couple of other areas. First, I am
interested in knowing the origins of the disease. I would like
to know that for the very obvious reason that if we know the
origin of the disease, maybe we can stop other diseases of the
same type and potency from coming into the country if we have a
sense of what the origin of the disease is.
Second, I am interested in knowing what the effect of
spraying is on the mosquito population, specifically whether
the benefits of spraying are outweighed by the negative impacts
of spraying. Obviously, we have known for years that certain
types of spraying do have a significant environmental impact.
Is it appropriate for us, however, to initiate an aggressive
spraying program in the face of those environmental impacts
because the human impact of not doing the spraying is more
significant? Even though our witnesses are not from the
environmental community, I would be interested in hearing their
comments on that.
And third, and probably of most significance is the issue
of our blood supply and how we maintain the integrity of our
blood supply in light of the virus, which appears to be a
potential threat to that blood supply.
These are big issues. They are big issues for us from a
public policy standpoint and obviously from a public health
standpoint and I certainly appreciate the Chairman holding
these hearings and bringing forward these excellent witnesses
so that we can get some information out to the public on this
question. Thank you.
Senator Durbin. Thanks, Senator Gregg. Senator Dodd.
OPENING STATEMENT OF SENATOR DODD
Senator Dodd. Very briefly, Mr. Chairman. I think you have
covered the ground and Senator Kennedy and Senator Gregg have
raised some very appropriate questions. I am obviously anxious
to hear from our witnesses.
As Senator Gregg and Senator Kennedy has pointed out, I
guess those of us from the East Coast feel this more pointedly
because it has been around now since 1999 for all of us, though
obviously it is moving across the country and indications on
the very West Coast are that there are some cases that have
sprung up. So we are very interested in getting an answer to
There is nothing more intimidating or frightening to people
than to have something apparently almost as innocent as a
mosquito, although history has shown how lack of innocence a
mosquito can have, but certainly in recent times, relative
innocence and bringing such hardship. So I am very interested
in hearing what our witnesses have to say.
I think it is important at the hearing here we also
commend, however, the Centers for Disease Control, NIH, the
FDA, as well, who have been working pretty hard on this, our
State and locals. We received $200,000 in Connecticut already
in this area. We have not had a human life lost. We have had a
number of cases identified in our State, so it is a growing
This is a very important hearing and I commend both of the
Chairs for bringing two committees together. This is a
wonderful example of how committees can work together with
somewhat overlapping jurisdiction to try and address an issue
I also want to underscore the point Senator Kennedy made
here. It is one that needs to be made, and that is while the
answer here is not just writing the check, it obviously does
take investment of resources. That $200,000 that my State
received from the Federal Government has been awfully important
to my State, particularly in times when we are facing huge
budget deficits. And so when people out there talk about
homeland security, obviously we narrow that definition to some
degree, but certainly if you ask the average citizen in our
country whether or not they think this is an issue that
deserves an aggressive action on the part of local, State, and
Federal Government, I think the answer would be a resounding
yes, before this gets totally out of control and we find
ourselves in a far more difficult situation.
I want to underscore that point, that as we look at these
issues and our budgets, obviously, this is an important one. It
certainly is in our State. Pick up the morning paper here in
Washington, DC this morning and ask the people of Virginia
whether or not they think this is an important matter, having
lost another life.
So I thank you and I look forward to the testimony.
Senator Durbin. Thanks, Senator Dodd.
I learned this morning of two more deaths in Illinois, one
in Peoria and one in Chicago. Again, as I mentioned at the
outset, for some reason, our State is leading the Nation in
this. As you mention, it started on the East Coast. The
infection has now been found in 41 States and the District of
Columbia, so it is truly a national challenge.
Let me welcome the first panel. Dr. Julie Gerberding, thank
you, the new Director of the Centers for Disease Control and
Prevention, the Federal agency charged with coordinating our
national response to the West Nile Virus. Dr. Anthony Fauci,
truly a leader in public health and world recognized and
respected, Director of the National Institute of Allergy and
Infectious Diseases at the National Institutes of Health. He is
going to discuss the ongoing biomedical research related to the
West Nile Virus. And Dr. Jesse Goodman, who is the Deputy
Director of the Food and Drug Administration, Center for
Biologics Evaluation and Research, who is focusing on the
threat of the West Nile Virus to the safety of our blood
Thank you for joining us. It is customary in our
Subcommittee to swear in all witnesses and I would ask you to
Do you solemnly swear the testimony you are about to give
is the truth, the whole truth, and nothing but the truth, so
help you, God?
Dr. Gerberding. I do.
Dr. Fauci. I do.
Dr. Goodman. I do.
Senator Durbin. Thank you. The record will indicate that
the witnesses have answered in the affirmative.
I would ask you each to give us, if you can, in 5 minutes,
a summary of this challenge as you see it. We may have
colleagues coming in from time to time. We are facing a 10:30
vote, so we are trying to get the first panel's testimony in
before that and we would appreciate any help you could give us
in reaching that goal.
Dr. Gerberding, please commence.
TESTIMONY OF JULIE LOUISE GERBERDING, M.D., M.P.H.,\1\
DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Gerberding. Good morning and thank you. Thank you, Mr.
Chairman, thank you, Chairman Kennedy, Senator Dodd, Senator
Gregg, and all of the Members of the Committee. It is a great
privilege for me to be here in my first appearance before
Congress as the Director of the CDC and the Administrator of
ATSDR and I really first want to thank you for all the support
that you have given CDC and ATSDR in our work in public health
over the last many years, both here in the United States but
\1\ The prepared statement of Dr. Gerberding appears in the
Appendix on page 53.
We are 600 miles away from Washington, but not out of
sight, and we would certainly welcome you visiting CDC in
Atlanta and would, of course, like to visit you in your own
States, as well, but really would like to show you the progress
that we have made, the first steps, at least, in rebuilding the
public health infrastructure, in large part because of the
support this Committee has given us. I think we can convince
you that we are accountable for those investments and really
have made some important progress.
Today's topic is, of course, West Nile, which really is a
prime example of an emerging infectious disease. So all of the
infrastructure and all of the components of public health
really have to come to bear to help us identify and respond to
this new emerging infectious problem in the United States. It
is also an excellent example of how the investments that we
have made in the bioterrorism infrastructure have assisted us
in responding to other public health threats, as well, and I
will get back to that in a moment.
As of this morning, there were 1,965 human cases of West
Nile Virus reported from 32 States and Washington, DC. At least
94 of these patients have died. Our concern for the human toll
of this disease is enormous. Clearly, it is not a problem just
for the people who have been diagnosed with the more severe
forms of the illness, but for every case of severe
encephalitis, there are 150 additional people who have been
infected, and about 20 percent of those have milder symptoms of
the disease. So it is having an enormous impact on all of us.
I will just say, I have had personal experience with this
in my own backyard. My husband acquired West Nile infection,
fortunately a mild case, but we experienced firsthand how
alarming and how disturbing this illness can really be.
This is a mosquito-borne disease. It was first diagnosed in
Uganda in 1937, and since that time, it has been the cause of
numerous outbreaks in the Middle East and Eastern Europe. Over
the last 10 years, those outbreaks have been conspicuous in
Russia, Romania, and Israel, and the new finding in the last
decade has been the association of those infections with the
severe neurologic disease.
The infection arrived in the United States in New York City
in 1999, and you can see here in the blue the areas of the
country that were involved with West Nile during 1999. In
green, the spread in the year 2000 up and down the East Coast.
In the pink, 2001, spread north, and then further into the
central parts of the United States. And finally, this year, in
yellow, the further extension to the West and to the South. I
should also mention that we have cases in Canada. We are
conducting surveillance in Mexico and are suspicious that we
have got cases in Mexico, and as the mosquito vectors and the
infected birds migrate North and South, we can only expect this
pattern of progression to continue and we would anticipate a
further extension next year into the West Coast.
The life cycle of this virus really moves between birds and
mosquitoes. So the mosquitoes move the infection from one bird
to another, and over the course of the summer, there is an
acceleration of the concentration of the virus in the infected
birds, so the mosquitoes become much more efficient at
On this graphic, you can see on the top the counties in the
United States that have had human cases, including one human
case in Los Angeles County. But in the middle, the counties
that are reporting infections in birds. And finally, on the
bottom, the counties that are reporting infections in horses.
You see it is a tremendous burden of infection across the
United States, concentrating this year predominately in the
South, Louisiana, Mississippi, Alabama, and Arkansas, and then
in the Midwest, particularly in Illinois, Michigan, Ohio, and
the other Central States.
Where is this virus going to go? It is too soon to tell,
but we know that it is following the pattern of birds and we
can predict where the next human cases are going to be by doing
the surveillance in the bird and animal population, because
they do accurately predict where the next wave will be, and
certainly, the information we need to target our integrated
vector control programs.
So, in other words, when we see that the virus is active or
there are dead birds in a particular area, then we can go in
there and CDC will provide the technical support to that
jurisdiction to initiate the appropriate steps to control the
vector and also accelerate the information campaigns with the
clinicians and the public health system and the people to
ensure that the individual protective measures are being taken.
Those protection measures include eliminating, to the
extent possible, standing water where mosquitoes breed. That is
a very important component of this. But in addition, the advice
to individuals to wear insect repellant that contains DEET when
they do go outside, particularly in the evenings and the
mornings when the most common mosquitoes involved in this feed.
Also, to use proper screens on the windows and do the other
kinds of things to help avoid mosquito bites.
One of the concerning aspects of this problem is that it is
present in virtually all kinds of mosquitoes and all birds, so
it is unlike some of the other vector-borne virus infections.
There are many prevention steps that we are taking, many
more steps that need to continue, but I think we have made
substantial progress. We are managing this outbreak through our
Emergency Operations Center, the same way we managed anthrax
through our Emergency Operations Center, and I think that helps
us provide our coordination and communication functions, as
well as the training and education of clinicians that are so
vital to the detection and management of the patients.
We look forward to doing more, but I think this is a true
example of the importance of a public health infrastructure and
the integration with State and local partners, as well as our
partners in the Federal Government through HHS and Secretary
Thompson's leadership to really get this job done right, and we
look forward to continuing to make progress. Thank you.
Senator Gregg. Mr. Chairman, could I just ask one
Senator Durbin. Sure. Of course. Senator Gregg.
Senator Gregg. You said use mosquito repellant that
Dr. Gerberding. Correct. DEET is a mosquito repellant that
keeps mosquitoes from attacking because they cannot find your
scent. It comes in different concentrations. It needs to be
present on the skin or on the clothing in order to serve as an
effective repellant and it is the only mosquito repellant that
we have documented evidence of efficacy for.
Senator Gregg. There was a fair amount of discussion in the
last 10 years that people should not use DEET-based mosquito
Dr. Gerberding. Well, I think the data that we have
indicate that it is effective at preventing mosquito bites and
we are not aware of any toxic effects in humans. For children,
we recommend that very small infants not use it because their
skin is more absorbent, and for pre-adolescent children that it
not be used in a concentration higher than 10 percent. But we
have not documented adverse health effects from using this
product to date.
Senator Gregg. Thank you.
Senator Durbin. Thanks, Senator Gregg. Dr. Fauci.
TESTIMONY OF ANTHONY FAUCI, M.D.,\1\ DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN
Dr. Fauci. Thank you very much, Mr. Chairman, Members of
the Committee. It is a pleasure to be here with you this
morning to talk about some of the research endeavors at NIH
with regard to West Nile Virus.
\1\ The prepared statement of Dr. Fauci appears in the Appendix on
I want to point out first that West Nile Virus is a member
of the flavivirus family and we have been studying for years
other related viruses as you see there, such as yellow fever,
Japanese encephalitis, and dengue. So our ability to hit the
ground running with regard to West Nile was really based on the
fact that we have a program with flaviviruses that had gone on
As you heard from Dr. Gerberding, there is a wide range of
clinical manifestations with West Nile Virus. Although only one
out of five individuals develop mild febrile disease and only
one in 150 to 200 develop serious complications, there are many
enigmas associated with what has been called the path of
physiology of this disease, questions that we at NIH are
directing our endeavors to.
Of note also, most fatal cases are in individuals greater
than 50 years old. There is a very sharp dichotomy in case
fatality rate and age, which is something we need to probe more
closely because there are some important clues about the body's
ability to handle infections in general, but particularly this
infection related to age.
Now, with regard to the research agenda at NIH, it is
divided into several directions, some of which we have already
been quite successful in. First of all, as I mentioned, we are
studying the basic research on the virus, which gives us many
clues, not only in the disease itself, but also in the
development of vaccines, diagnostics, and therapeutics. We are
studying vector biology to ask some of the questions that Dr.
Gerberding alluded to. Why, with this virus, is virtually every
mosquito able to be a vector and what is the relationship
between the vector, the intermediate hosts, and the primary
hosts? We also have, obviously, a very intense effort in
vaccine development, antiviral screening, which I will get into
in a moment, and rapid diagnostics.
Some of the accomplishments that we have been able to
achieve over the last year and a half to two, is the
development of what we call a chimeric West Nile Virus vaccine,
which is going to cut off the time requirement to get to a
vaccine probably by several years. We screened over 300 drugs
and we have about 15 hits of drugs that might be promising as
We have a successful animal model, the golden hamster,
which has allowed us to test the vaccine with direct challenges
in an animal. Development of an animal model is critical in
pursuing the pathogenesis and treatment of diseases.
We are, together with private companies as well as our
sister agencies in the Public Health Service and the Department
of Health and Human Services, working on rapid diagnostics.
And finally, we are responsible for the world reference
center for arboviruses, which is a worldwide resource, so that
when you have a new virus and vectors, you have a whole
reference center that people can pull out and compare previous
This is the model that I was referring to. It is really
quite interesting. We already have an attenuated yellow fever
virus, which as I mentioned on the first poster is one of the
flavivirus family. So what we are able to do is to take the
genes of the coat protein of West Nile Virus and insert it into
the genes of the already existing yellow fever vaccine to
develop what we call a chimera that is what we say is a yellow
fever backbone but is actually expressing the proteins of West
Nile. That really does cut off several years in the process of
The company, Senator Kennedy, that is working on this is
Acambis in Massachusetts and we are intramurally doing it also
with dengue, so it is really quite promising.
The plans and the opportunities that we have, as many as we
would have advances, there are as many unanswered questions, so
our programs for the coming year will be directed at those. We
are going to try and develop new products through expanded
Importantly is the immunity to West Nile Virus, including
cross-reactivity. We found a very interesting finding in the
animal model. If you infect the hamster with either yellow
fever, St. Louis encephalitis, or dengue and they recover from
it and then you challenge them with West Nile Virus, they are
protected against West Nile Virus, which means the underlying
immunity that you might even get from a yellow fever
vaccination perhaps might give some degree of protection, which
again is fortifying evidence why we are on the right track with
the vaccine development.
Also, the human disease cases, the consequences and age
dependence, why are we now seeing anterior horn disease similar
to poliomyelitis? Why is there such a sharp age dependent
discrepancy in mortality? These are all the future unanswered
In addition, we are looking at immune-based therapies,
interferon alpha, hyperimmune globulin, as well as some non-
immune-based approaches. And finally, understanding the ecology
of the host and the vectors.
So in summary, Members of the Committee, we belong, as Dr.
Gerberding alluded to at the conclusion of her discussion, is
that this is really part of the continuing spectrum of the
threat of emerging and reemerging diseases, be they naturally
occurring diseases or diseases that are deliberately
perpetrated on society in the form of bioterrorism. It is all
part of the program of understanding the relationship between
emerging diseases and their human hosts. This falls right in
the middle of it and is a cogent example of just yet another
thing that we, the human species, have to face, from the flu
pandemic of 1918 to the AIDS epidemic, which we are still in
the middle of suffering from that, to know a new and reemerging
disease. We will, according to what was said just a few moments
ago, pool the resources of the Department of Health and Human
Services and all the sister agencies to try and meet this
challenge and hopefully protect the American public against
future challenges. Thank you very much.
Thank you, Doctor.
Senator Durbin. Dr. Goodman.
TESTIMONY OF JESSE L. GOODMAN, M.D., M.P.H.,\1\ DEPUTY
DIRECTOR, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, FOOD
AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN
Dr. Goodman. Good morning, Mr. Chairman and Members of the
Committees here. I am Jesse Goodman, an infectious disease
physician and scientist and Deputy Director of the Center for
Biologics Evaluation and Research at FDA. I thank you for
providing FDA with the opportunity to speak with you here today
about West Nile Virus.
\1\ The prepared statement of Dr. Goodman appears in the Appendix
on page 60.
As Dr. Fauci and Dr. Gerberding have said, there are, and,
in fact, always will be, newly emerging infectious diseases
which pose a threat to human health, and some of these will
likely threaten the safety of the blood supply. West Nile Virus
is the newest of these such challenges.
In this testimony, I would like to do three things. First,
I will provide a brief chronology of recent events from the
perspective of blood safety. Second, I will tell you about what
the response has been so far. And finally, I will tell you
about our plans to further address the problem.
I think you will see that we have come a very long way in
just three short weeks, and I would like to mention the
extraordinary cooperation between CDC and FDA and the
impressive pace with which the case investigations have been
conducted. I would also like to thank the involved States and
the blood organizations whose response to date has really been
Until less than a month ago, the potential threat of West
Nile Virus to the blood supply was thought to be very low.
Because of the dramatic increase in the spread of West Nile
Virus this year, on August 17, FDA, in consultation with CDC
and NIH, issued an alert. This alert to the blood banks
emphasized the importance of careful attention to screening
procedures for blood donors, especially the exclusion of donors
with even mild flu-like symptoms which could be early signs of
West Nile Virus infection.
Then, about 3 weeks ago, the initial results of the
investigation of a cluster of cases among the organ transplant
recipients from a single organ donor led to strong suspicion
that the virus could be transmitted by organ transplantation.
We now believe it almost certain that the organs from a single
donor carried the infections to four recipients. The source of
the donor's infections may have been either natural, from
mosquitoes, or from transfusions.
During our current state of heightened alert, several cases
in which West Nile Virus disease developed in the days to weeks
following a blood transfusion, both in and out of the setting
of organ transplantation, have now been reported and are under
investigation. In each case so far, the patients were from
areas of known natural disease transmission.
However, as you have heard, special studies of blood
donated to a single patient in Mississippi who later developed
West Nile Virus disease suggested that three blood donors may
have unwittingly and coincidentally had West Nile Virus in
their blood at the time they donated. So far, one of these
donors' infections has been confirmed.
Based on these ongoing investigations, we have identified a
risk to blood safety, but I must caution you that we do not
know at this time how big or small that risk may be. Critical
studies are now being implemented in partnership with the other
agencies, the States, the blood organizations, and in different
donor populations to assess the risk to the blood and organ
recipients in this country.
Meanwhile, we have taken several important steps. First, we
are continuing to encourage the reporting of cases of West Nile
Virus that follow recent transfusion or organ transplantation.
If a case is reported in a recent donor, any blood products
still available are being withdrawn.
Second, FDA is working with blood banks to improve the
reporting of post-donation illnesses and appropriate actions to
be taken, including withdrawal of products where needed to help
Third, because of the potential for West Nile Virus
transmission by donors who never even develop any symptoms of
infection, FDA believes it is important to be ready and able,
if and when needed, to move rapidly towards screening testing
of donor blood. No validated test is currently available for
donor screening, and such screening of a large number of
samples cannot be implemented overnight. However, I want to say
there are some promising assays.
To jump start the process of getting to a reliable and
practical diagnostic test, last week, we took the unusual and
proactive step of meeting with the American Association of
Blood Banks, AdvaMed (a Medical Diagnostics Device
Manufacturing Association) and other partners in the blood
banking and diagnostic testing industries, along with
laboratories whose current tests could be potentially adapted
to meet this need. CBER will also continue and, if necessary,
expand its related work relevant to the development and review
of potential West Nile Virus diagnostics, vaccines, and
treatments, such as mentioned by Dr. Fauci.
I am pleased to report that the medical diagnostics and
blood banking communities are highly engaged and motivated by
the potential public health threat that we are now facing.
While the success of these efforts depends largely on their
overcoming scientific and technical obstacles, some of which
may be significant, our hope is that, if needed, a West Nile
Virus screening test for blood could become available, at least
for study under investigation and new drug application, for the
next transmission season.
At the same time, we are continuing to explore a relatively
new strategy for treating blood to kill microbes called
pathogen inactivation, and we are working with the developers
of these technologies to help carefully assess their safety and
determine whether they can be important in helping deal with
West Nile Virus.
In conclusion, while we believe there is sufficient
evidence to say there is a risk to the blood supply from West
Nile Virus. We should keep this risk in perspective. There are
approximately 4.5 million people in the United States who
receive blood products each year. Both blood transfusion and
organ transplantation are often life saving or life enhancing.
While it is currently believed that the risk is low, it is
important to say that our knowledge is very recent and is
limited and it is changing rapidly. We believe patients should
be aware that this risk exists and can discuss any concerns
about their medical treatment and possible options with their
FDA, CDC, HRSA, and all of our partners are monitoring the
situation. We will continue to work together to better
understand and deal with the risk as quickly as possible.
Meanwhile, let me also take the opportunity to remind
everyone that blood donation is a key to maintaining an
adequate blood supply in our country, and regardless of the
findings and concerns here, blood donation remains safe. Blood
has been in short supply and we encourage and thank all the
Americans who donate blood.
We have come a long way in a few short weeks, and I am
optimistic that we can and will respond to this new challenge
rapidly and effectively. Success in controlling the mosquito-
borne epidemic itself will be critical in determining the risk
of infection in the blood supply and the need for future blood
Again, I thank you for the opportunity to be here today and
welcome your questions.
Senator Durbin. Thank you, Dr. Goodman.
We have many questions, and as I mentioned earlier, there
is a vote on at 10:30. I see that two or three of my colleagues
have joined us and I would like to ask them if they would not
mind giving a very brief opening statement, perhaps 2 minutes
or 3 minutes, and then we can go to the first questions. Let me
start with Senator Frist, then Senator Landrieu, and Senator
OPENING STATEMENT OF SENATOR FRIST
Senator Frist. Thank you, Mr. Chairman, and I thank all
three of you for being here today and for your excellent
presentations. All three of you have emphasized the importance
of ``dual use'' of the resources that we, through government,
make available to you--resources targeting bioterrorism as well
as other public health threats.
By providing additional resources since September 11 to
combat bioterrorism, your discussion of the response to West
Nile Virus has been a good demonstration of such ``dual use.''
With your chart, Dr. Fauci, you mention other public health
threats--HIV/AIDS, West Nile Virus, and the flu. You could very
easily add smallpox, which is on the front page of the paper,
as well, in terms of the need to prevention, response, and
surveillance, as we go forward. So over the course of the
morning, I would be interested in both this panel and the next
panel commenting further on how we can address strengthening
our public health infrastructure to address all of these public
The spread of West Nile Virus started in 1999. We see where
we are today. Dr. Goodman, you said we have no screening test
for West Nile Virus, and we essentially have no treatment
today. Additionally, the virus is in our blood supply, to some
extent. The viral contamination of the blood supply can strike
great fear in people's hearts and minds, and it shows there is
a lot to be done.
Knowing the natural history of such a disease, did we
respond as quickly as we should have over the last 3 years.
What do we expect in the next month? Due to the cooling
weather, the risk of transmission through the mosquitoes is
linked. Is West Nile Virus going to disappear, or is it going
to come back with a bigger surge next year?
Senator Durbin. Thank you, Senator Frist. Senator Landrieu,
if you would like to make an opening statement.
OPENING STATEMENT OF SENATOR LANDRIEU
Senator Landrieu. Very briefly, Mr. Chairman. Thank you for
calling this hearing. It is very timely, and as you know, the
most cases of West Nile Virus have been in the Chairman's
State, Illinois, but Louisiana is second, with 11 deaths and
over 260 people infected. In our capital city in Louisiana, we
reported 3 deaths and 42 people ill. So while this is a very
serious situation everywhere, it is particularly urgent in
Mr. Chairman and Members, I am very pleased that one of our
parish presidents is here with us, Nickie Monica of St. John
Parish, who will be testifying as part of the second panel.
Louisiana has been spraying for mosquitoes since the very
first person landed in Louisiana over 300 years ago, trying to
get rid of these pests, and up until recently, that is what
they were, pests. It is extremely aggravating and in some ways
debilitating to be working in a place where mosquitoes can be
serious pests, but never before have we faced this kind of
illness that can bring with it death. People are very
My point would only be today that while we focus Federal
help on the disease itself, on the infection and the treatment,
let us remember who is on the front lines, our parish and
county officials, trying to get funding for the spraying to
prevent the spread by mosquitoes. We cannot, I think, lose
sight of the need that our local officials have just for the
eradication of the carriers of this deadly disease, the
So I thank the panel. I am looking forward to hearing from
you all. Thank you, Mr. Chairman, for calling this hearing
Senator Durbin. Senator Landrieu, thank you.
Senator Warner, I know you saw this morning's paper.
OPENING STATEMENT OF SENATOR WARNER
Senator Warner. Yes. This is our paper today. I point out
it is front page news showing the depth of the concern, as
pointed out by our colleague, Senator Landrieu. When the
question comes, I hope you would share with us what knowledge
you may have, apart from the scientific. We gained the clear
impression everything can be done by the organizations, State
and Federal, who have jurisdiction over problems like this, but
what about advice to the citizens on how they might alter their
daily activities, themselves and their children, to minimize
this? The obvious, of course, is at twilight, when the
mosquitoes are most active, get indoors, I suppose. Simple
things like that would be helpful.
Senator Durbin. Thank you, Senator. Is there anything
further you would like to add?
Senator Warner. No.
Senator Durbin. What we are going to try to do is this. I
am going to ask Senator Kennedy and Senator Gregg to ask the
first round of questions, and if a vote starts, I will take off
and try to make that vote and return so that we can just keep
this moving apace. But let me open with Senator Kennedy's
Senator Kennedy. Thank you very much. Thank you.
Let me ask you, do you think there is any way to eradicate
the West Nile or are we stuck with this every summer from now
Dr. Gerberding. The pattern of the similar viruses in this
family is that they wax and wane over years, but we can never
really completely eradicate them from the population because
they are just too deeply embedded between the birds and the
mosquitoes. As we over-winter, meaning the mosquitoes in the
Southern part of the United States do not die off in the
winter, so they may continue to transmit all year round, it is
just about impossible to completely eliminate it.
Senator Kennedy. Is there anything that you can tell us
about whether it is rising or declining? What can we anticipate
for the next year, next summer, the summer after? What does
your analysis reflect on this?
Dr. Gerberding. In terms of this year, in the Southern
States, the epidemic started very early and has already peaked
and is beginning to fade away. In the Northern States,
especially around the Great Lakes, it started much later, much
more rapid increase in cases, but there, too, we are beginning
to see a decline suggesting that this year's epidemic is
beginning to wane off. And, of course, as the weather gets cold
up North, we would expect to see a marked reduction in cases
because the mosquitoes would no longer be feeding.
Senator Kennedy. One of the few advantages of the colder
Dr. Gerberding. That is right.
Senator Kennedy. But in any event, what it is for next
year, it is difficult to anticipate whether it is going to be
more virulent next year during the spring and the summer? It is
difficult to tell?
Dr. Gerberding. It is very difficult to tell because, in
part, it depends on the weather, and it also depends on the
micro-climate. The West Coast is very different from the South,
but it also depends on to what extent we get out there early on
with the integrated control programs and deal with larvacides
and also the extent to which people implement their own
personal protective measures.
Senator Kennedy. Dr. Fauci, you mentioned the development
of a vaccine. How close are we to the development of a vaccine
Dr. Fauci. The phase one trial, where we put it into humans
and start determining safety, are going to be underway
imminently. Hopefully, what we will have is about a year's
worth of that and then go right into phase two. So I would
imagine it is 3 or so years away, which is really light speed
when you are thinking in terms of the development of a vaccine.
So we will likely have one, if successful, within the next few
Senator Kennedy. What will that mean for people, that they
will be able to take it and be immunized to the disease, is
Dr. Fauci. The same say, since it is a flavivirus, as I
pointed out, the same way when you get a yellow fever
vaccination. You are essentially protected from yellow fever if
you go on a trip to a yellow fever endemic area. It might turn
out, depending on the evolution of the epidemic, that we would
take at-risk people, particularly people who are
immunosuppressed or people who are beyond a certain age, and
they will be the first targets of a vaccine program.
Senator Kennedy. Dr. Goodman, you mentioned that you have
been meeting with the blood banks and those that have been
involved in that industry, that they are motivated. If needed,
you could mandate a test, but you are looking at other tests
that may be helpful in terms of dealing with the pathogens, I
guess, in the total blood supply.
But why should we not mandate a test now? The idea, as I
understand it, is that you mandate the test, it builds up the
interest from those that may be interested in producing a test
and it only goes in effect when they develop it, but it creates
the market. It creates the financial incentives for those to go
Given the evidence that we have in terms of the blood
supply, I heard you when you said that it may not stay in the
blood supply for a very long time, but we have seen this
infection expand. For the people that are going to be
endangered, that is not a very good, satisfactory answer. Why
not go ahead and mandate the test now?
Dr. Goodman. Well, I think it is a good question and what
we have signaled very strongly to the diagnostics industry and
the blood community is that based on this rapidly evolving
evidence we are seeing, that we think it is very likely that
there will be a need to do generalized testing of blood.
Senator Kennedy. Let me stop you there. What does it mean
to people that are watching this, it looks like the
development, that there may be a reason that we go in to try
and may do this in the future, I mean, these are as current as
this hearing. People are out there and they are concerned. When
we can go ahead and mandate this test, why do we not just go
ahead and make this a matter of public policy? Why not just go
ahead and do that?
Dr. Goodman. First of all, we are proceeding as if
generalized testing of the blood will be needed, so in that
sense, I totally agree with you. In terms of mandating----
Senator Kennedy. Excuse me, and I want to give you a chance
to finish. The generalized test that you are looking at is in a
much broader kind of scope, to look at a variety of different
things rather than just the West Nile.
Dr. Goodman. Oh, no.
Senator Kennedy. Just on the West Nile?
Dr. Goodman. I am talking about a specific West Nile test.
Senator Kennedy. West Nile, all right.
Dr. Goodman. Absolutely, sir.
Senator Kennedy. Because the time is limited, the fact is
that you are going to consider whether you are going to go
ahead and mandate a test or not, and in what period of time,
and how long will it take, estimate?
Dr. Goodman. OK. What we are aiming for is to work with the
diagnostic and blood industry to rapidly assist and facilitate
transfer of existing testing technology that is currently in
place at CDC, other research labs, so that it can be done on
broad scale if needed in a very rapid fashion.
In terms of the issue of mandate, there are two ways that
FDA can assure that needed testing of blood is done. One is
through regulation, normal comment and notice rulemaking,
which, as you know, takes time. The other is we can issue a
guidance for immediate implementation, which blood banks and
the community have interpreted and followed as parts of our
requirements for good manufacturing practices for blood. So as
we continue to look at this evidence, we will issue guidance as
and when needed, and I think we are behaving as if it will be
And I would also say that the financial issues you raise
are important ones. We do not make the diagnostic tests, and in
a way, the industry needs to be able to see that there is a
market in order to be incentivized to do this.
What I can report is based on a meeting we had with a
number of key diagnostic firms and other parties last week,
they are proceeding as if they perceive that there is a market
and they are moving very rapidly to work with us and have
testing available should we need it in a general way. But I
Senator Kennedy. My time has expired. I want to be clear.
It seems to me that the evidence is sufficient that we ought to
indicate a mandatory test and create the kind of climate and
atmosphere where they are going to do what is necessary, and
that is the financial investment to move ahead. It seems to me
that we have the sufficient material. I thank the Chair.
Senator Durbin. Thank you very much. Senator Gregg.
Senator Gregg. I do not want to pursue that discussion, but
I have a lot of trouble mandating a test that does not exist. I
think that the object is to get to a test that does exist and
then determine whether or not to mandate it.
Senator Kennedy. That is what it does, Senator. It only
goes into effect when they get it. You create the business
climate and the incentives to do it, and that is exactly the
way it is done with this kind of a problem.
Senator Gregg. I am wondering whether the panel would
comment on whether you should have spraying for the killing of
mosquitoes. Do you consider this virus to be a significant
enough threat that we should aggressively pursue in the various
communities a policy of spraying?
Dr. Gerberding. First of all, it is important to recognize
that no pesticide is 100 percent safe, and so we do not want to
use them if we do not have to use them.
The approach to controlling mosquitoes is really best done
with an overall integrated approach, which starts with, as I
said before, draining the standing water where the mosquitoes
breed, wherever that is possible. In addition, using
larvacides, which does not involve spraying and is a much
safer, much less toxic form of mosquito control, can be done
early in the year, often using organic materials that are safe
for human health, is a very effective early season strategy
that can attenuate the whole mosquito epidemic curve.
Spraying is really the last resort, and the technical
assistance that CDC provides usually suggests that we not
institute spraying programs until there are actually human
cases in an area, because we try to deal with the problem
through all other means first.
Senator Gregg. You mentioned this issue of DEET. I have got
to revisit that, because I know in my region of the country,
where there is a tremendous amount of hiking and woods
activity, that for the last few years, there has been a very
aggressive effort to not sell or use anti-mosquito lotions that
include DEET because there was some perception that the DEET
was a problem. It penetrated the skin and posed some
significant health problems. But it is the position of the
medical community that DEET is not a problem unless it is with
a young child?
Dr. Gerberding. That is the information we have available,
but I will go back and----
Senator Gregg. No, that is fine. I just think we need to
sort of clear the air on that, because there is a cottage
industry out there saying, do not buy a product that has DEET
in it, and it is quite aggressive, I can assure you, especially
in the hiking community in New England.
If people have had a transfusion recently, what level of
concern should they have, or if they have had some sort of
major blood work, what level of concern should they have?
Dr. Goodman. I think, again, this is an issue that has to
be kept in the broader perspective. We are taking this very
seriously. We are very concerned by any transfusion-transmitted
As I mentioned, there are several case reports which have
been received by the Federal agencies in which blood
transfusion is raised as a possibility for disease
transmission, and one of these, the evidence is strong right
now, we believe. So we have to take this seriously, although,
again, as I mentioned, we have to take this in the context of
4.5 million people receiving blood in the United States a year.
So while we take this risk to the blood supply very
seriously, and we are being very aggressive about it, for
people for whom a blood transfusion is life saving or an organ
transplant is life saving, the risk is likely to be much
smaller than the potential benefit and people need to keep that
in perspective. But in fairness, it is a rapidly evolving
situation and we want people to be aware of the potential risk.
Senator Gregg. And what do you see as the time frame that
you will have a screening test that could be generally
Dr. Goodman. I think it is an excellent question and I just
wanted to also get back to a little bit of where Senator
Kennedy's concern was coming from, that it would be very
difficult for us through whatever regulatory process to say,
you must perform a test that is not, in fact, currently
available. What we are trying to do is everything we can to get
it to the point where a test is available and we really are
giving that message.
What we are hearing is that by doing several things, trying
to work on technology transfer from existing tests--it is not
as if things have not been developed which could be applied to
this, but the issue is taking an existing test and potentially
automating it and applying it to millions of samples. What we
are hearing from partners in industry and the blood banks is
that they are hopeful that they should be able to do this in
time for the next major transmission season.
As I mentioned, there are some significant obstacles, but
FDA also--we can help with this. We can allow use of these in a
test situation before they are licensed to help provide
additional public health protection. So certainly from FDA's
point of view, this is a high priority. We will work with these
companies. We will do whatever we can to help them get it out
there. But in the end, we are not completely determinative----
Senator Gregg. Are we talking 6 months, a year, 2 years, 3
Dr. Goodman. I think an optimistic version would be to have
this available for next summer for the next major mosquito
transmission season, at least for use in a study situation
under investigational new drug status at FDA. If we can do it
sooner than that, we would be delighted to see it used again in
pilot tests, but I share your sense of urgency if this is
needed. Thank you.
Senator Gregg. I appreciate the panel's commitment to this.
Senator Durbin. Thanks, Senator Gregg.
Let me ask the panel, one of the most important things that
we do here is to try to put things in perspective, and I think
it is very important when we talk about issues of public health
to put them in perspective. There is a tendency for us to rush
to the disease du jour, and for the press and politicians to
focus on that and to ask the American people with laser-like
intensity to join us. And certainly on a daily basis, we pick
up the newspaper, as Senator Warner did this morning, I hear
from my home State, and Senator Landrieu, who will be back,
hears about Louisiana constantly.
Dr. Fauci, when you put your poster up here about this
challenge, you compared it to a flu pandemic and the AIDS
epidemic. Put this in perspective for us so that we can
understand what the public health threat is. The numbers from
year to year are astounding in terms of growth. But in terms of
the threat to Americans, give us your best analysis, and I will
ask the other two doctors to join you.
Dr. Fauci. Yes, and I think it is important, the point that
you brought out. Certainly, quantitatively, when you look at
the public health impact of the flu pandemic, which killed 25
million people, 750,000 in the United States; HIV/AIDS, 23
million dead, 40 million infected; I cannot imagine from
knowing what we know about mosquito-borne diseases, how they
spread, and the generally normal cyclic nature of
flaviviruses--if you look at what happens with St. Louis
encephalitis--it is extraordinarily unlikely that the impact of
West Nile Virus would ever get onto the same radar screen as
the two other diseases that I am talking about, flu and HIV/
Having said that, this is a disease that we need to take
seriously because it is not trivial. It is not going to wipe
out scores of millions of people, but it is an evolving
disease. This is the worst year that we have ever had.
Hopefully, next year, we will see a downswing, the same way in
the late 1970's with St. Louis encephalitis, when we had a
disease that had 1,000-plus cases and then the next year it
went right down.
But to say this is something trivial, I think would be far
underestimating it. So not as bad as the major public health
catastrophes that we had, but something we need to keep our eye
on and be ready for the worst. That is my evaluation.
Senator Durbin. In your business, in your profession, you
measure the ebb and flow of an epidemic----
Dr. Fauci. Right.
Senator Durbin [continuing]. And you have just given us an
example. Now, are we to surmise or conclude that based on what
I think are fairly primitive responses to a mosquito-borne
illness--insect repellant, fogging and spraying--that we can
see a decline? Can we anticipate a decline in infections and
deaths next year?
Dr. Fauci. I think so. I think that there is certainly a
possibility that with the preparation beforehand of mosquito
control, alertness on the part of the public regarding the
possibility, doing the kinds of things that Dr. Gerberding
said, that it is quite likely that we will see a decrease.
There is no guarantee.
The thing that we want to do is to do the public health
measures that Dr. Gerberding spoke about. The blood protective
mechanisms, regardless of what happens, forge ahead the way
Senator Kennedy said about getting a diagnostic test for the
blood, and at the same time have a vaccine available so that if
in subsequent years we do not see a decline, if we see actually
it continue to get worse and worse, then we will have a vaccine
that we can vaccinate susceptible people, we will have a blood
screening test, and the public health measures will be that
much more experienced. So that is what my assessment would be.
Senator Durbin. And let me ask the panel, for anyone who
would like to respond to it now, and that is, if this is the
type of virus that you have indicated, where if you have an
immunity to another similar mosquito-borne illness, that it
works against West Nile----
Dr. Fauci. Partially.
Senator Durbin. Partially. Let a liberal arts lawyer ask a
doctor, why are we not immunizing, then, for one of these other
possible illnesses with a safe vaccine, knowing that it will
have a positive and prophylactic effect when it comes to the
possibility of West Nile Virus infection?
Dr. Fauci. There are two reasons for that. One, because the
data in humans has not verified yet the data in animals. We are
doing studies looking at--there are actually going to be
studies that will be retrospectively going back, of people who
have actually been vaccinated for yellow fever, what is the
incidence if you do antibody tests to see if they have been
infected with West Nile and/or gotten sick? So you can get
scientific data. But the definitive proof that in humans it is
protective does not have enough data to allow us to then say,
based on animal models, we are going to go ahead and vaccinate.
The next issue is who to vaccinate. You certainly do not
want to generally vaccinate the entire population, because the
younger people really are at very little risk of serious
disease. With some notable exceptions, there is very little
Senator Durbin. Is this similar to the flu vaccine, where
we tell elderly Americans to be particularly attentive and
stress the need for it?
Dr. Fauci. Exactly.
Senator Durbin. All right. Thank you.
Let me ask you, Dr. Gerberding, in terms of our response,
we are talking about an added public health expense to a system
that is already straining to keep up with all of the
challenges, from sexually-transmitted diseases, immunizations
for children, and others. As Senator Kennedy said, we just take
it for granted that our public health system can absorb all
these expenses. Now we are putting into it another challenge.
Do we need to put more money into it, as well?
Dr. Gerberding. The investments that we made this year were
$29 million in the initial appropriation and then a supplement
of $18 million that primarily went to the States that were the
heaviest hit by the problem. That money was used to shore up
surveillance and tracking of the disease in the birds and also
to support the laboratories, but I think the system was
stretched. Many of the laboratories report that they are at
surge capacity. We have noted some delays in reporting the
infection and getting the information back to us to track the
epidemic. I think that we have done the best we can with the
resources that we have, but the system is very stretched.
Senator Durbin. Dr. Goodman, same question. Is this
situation, the barriers of transferring the technology and new
testing from the labs to the blood community, a question of
money or personnel or time? What is it?
Dr. Goodman. I think it is more an issue at this point of
technology, but I agree with your concern and Senator Kennedy's
comment that the industry has to feel that there is a potential
market here and be motivated by it. So I do think that is
important. But as I said, again, the message that I am getting,
at least informally and in recent meetings we have had, is that
they are rising to the challenge and taking this very seriously
and will move this along as quickly as possible.
Senator Durbin. The last time I gave blood, there must have
been 60 questions asked of me, maybe more.
Dr. Goodman. Right.
Senator Durbin. Are there new questions being prepared for
blood donors that really focus on West Nile Virus?
Dr. Goodman. Well, we are looking at this issue and working
with the blood banking community closely. As I mentioned, the
purpose of the alert back in August was the concern to prevent
people with even mild symptoms of West Nile from donating
blood. We are also working to be sure that people who
subsequently develop an illness report it so that intervention
can be made.
Some people have raised the issue, should we just be
questioning donors about mosquito bites? Of course, the problem
there is that one would exclude hundreds or thousands of donors
for every one potentially protected. I think we simply need to
know more about how much of this is out there to know how to
Senator Durbin. Thank you. Senator Warner, we have 5 or 6
minutes on the vote, but please, if you----
Senator Warner. Why do you not go ahead and I will just
Senator Durbin. I am finished at this point in this round.
Senator Warner. I was just going to take just a minute to
return to my opening comments about what we might at this
juncture in this problem advise the public who are following
it, who are concerned for themselves, for their families. What
steps should they take? Obviously, you spoke about the use of
repellant, but I do not want to put the wonderful American
tradition of the outdoor twilight barbecue out of our culture.
What advice can you give us?
And second, most people are conscious when they are bitten
by a mosquito. Sometimes you might not be aware when they make
a pass at you, but what is the lapse time between the bite and
the onset of the first symptoms?
Dr. Gerberding. Let me address your first question. The
population that I am the most concerned about are the elderly
people, who are at the highest risk for the severe form of the
disease. We have developed public service announcement and
media campaigns to specifically target that population, in
particular, advise them about the importance of, if they must
go outside in the evenings or the early mornings, to use the
insect repellant, but also just to wear an extra layer of
clothing, and I know that is hard when the temperature is hot
and it is humid outside, but to keep the skin covered and to do
things like drain the water out of the water pots in the
backyard. Most of the mosquitoes transmitting this virus live
in the suburban backyard, and so the things you can do to
eliminate their breeding ground can really help reduce the
mosquito pool in the neighborhood.
Senator Warner. Each of you who may have a little common
Dr. Fauci. Exactly. Just to reiterate what Dr. Gerberding
said, it really is some fundamental, simple things that you can
do, about warning everyone, particularly people who might be
more susceptible to getting serious disease, and do some very
I go out in my own backyard--I live in Washington, DC, and
every few days, you see something there that has collected
water, be it a flower pot or an innertube or whatever that the
children play with, and you just make sure every day you go out
and turn it over and do not leave any standing water, because
that really makes an impact.
Senator Warner. I think they are obvious to us. What about
the lapse time between your knowledge of being bitten and the
likely onset of this problem?
Dr. Gerberding. In general, the incubation period is
usually just a few days, 2 to 4 days, but it can be longer. We
have at least one patient with a flavivirus infection where we
know the incubation period was 17 days. But most often, it is
Senator Warner. Any variation of that opinion?
Dr. Fauci. No, that is about right, 3 to 15 days.
Senator Warner. I thank the Chair for a very good hearing.
Senator Durbin. Thanks, Senator Warner.
Let me ask, if I might, can we draw anything from the
recent evidence or indication that this creates sometimes
temporary polio-like symptoms? Is this a natural outgrowth of
what we saw initially, what appeared to be encephalitis, or is
this something new and alarming, or----
Dr. Fauci. It is. It is new and alarming, because what we
are seeing is that not only is this virus acting in an unusual
way, as Dr. Gerberding pointed out, it is infecting virtually
every known mosquito species. The mammalian, bird, and other
range is much greater. Now we are starting to see clinical
manifestations that if you open up a textbook and look under
West Nile Virus and its manifestations, something like anterior
horn cell, which is the cell that is infected to give you a
polio-like syndrome, that is really rather novel for this. So
we are concerned that the range of disease manifestations might
be broader than what one would have originally thought when you
think in terms of West Nile.
Senator Durbin. Because our panel here has such great
responsibilities and their time is very valuable, I am going to
leave to vote and turn this over to Senator Hutchinson for
questions and ask him if another Member arrives after he
finishes, if he would pass the baton along. If not, we will
just stand in recess until another Member does. Senator
OPENING STATEMENT OF SENATOR HUTCHINSON
Senator Hutchinson. Thank you, Mr. Chairman. I apologize to
the panel for having a conflict and only now arriving. I am not
sure of everything that has been asked.
I represent the State of Arkansas, where we currently have
9 human cases of infection and 18 more are pending at the CDC
for verification. Arkansas has also seen an unprecedented rate
of infections among birds and horses. Positive birds have been
found in 48 of the 75 counties in Arkansas. Our governor
recently released $1 million in emergency funds for mosquito
abatement at the local level, and this is in addition to almost
$400,000 that was recently granted to the State by the Centers
for Disease Control.
Now, as I understand, West Nile Virus has been common in
parts of Africa, the Middle East, and Eastern Europe for many
years. Because of the incidence in that part of the world, have
there been any documented studies in these affected regions and
countries about the transmission of the virus by means of blood
transfusions or organ transplants?
Dr. Goodman. No. There were no documentations in the many
areas where this disease has been epidemic or in previous years
of infection in the United States of any infection spread by
transfusion or organ transplantation. This was one of the
factors which contributed to the assessment that while this was
on the radar screen, the risk was likely to be low.
Senator Hutchinson. In the United States, how many cases
have now been verified this year?
Dr. Goodman. Of West Nile?
Senator Hutchinson. West Nile.
Dr. Gerberding. It is 1,947.
Senator Hutchinson. And the deaths have been?
Dr. Gerberding. Ninety-four.
Senator Hutchinson. Ninety-four. Is that ratio consistent
with what we see where the virus has existed for years and has
been more common?
Dr. Gerberding. In general, the mortality rate from the
severe form of the infection, which is the brain or the
meningitis form, is 10 percent, and that fatality rate has been
the same for several years and is similar to the fatality rate
observed in Europe. The ratio is not looking that way here
because our total case count includes some of the much more
milder forms of the illness, the so-called West Nile fever. So
we do not have the right numerator and denominator together to
give you the 10 percent.
Senator Hutchinson. Do they calculate the milder form at
all, or are they only looking in other parts of the world at
the more severe?
Dr. Gerberding. In general, it is the more severe form of
the illness that gets diagnosed accurately with the blood test,
and so when we report cases, we are usually limited to the
severe form, and that is where we calculate that 10 percent
Senator Hutchinson. Donor screening is one of the five
parts of FDA's blood safety system. If most people infected
with West Nile Virus either show no symptoms or flu-like
symptoms for just a few days, does donor screening become
ineffective since a potential donor will not necessarily be
conscious of the fact that they have the virus or they carry
Dr. Goodman. Yes, that is a real concern, that donor
screening in terms of asking questions about how people are
feeling, in terms of the medical exam for fever, as well as
other measures we have been promoting, such as calling back if
individuals develop illness and taking appropriate steps to
protect blood safety, these will only deal with part of the
problem if completely asymptomatic individuals can also
transmit this by transfusion. So that is why as we are
assessing the degree to which this is going on and a problem
with the blood supply.
We are pushing on the development and technology transfer
so that, if needed, there can be an actual blood test or donor
screening test, because that would be really right now the only
effective means of dealing with a problem, if it were a
significant one, in the asymptomatic donors.
Senator Hutchinson. And we do not know right now how much
of a problem it may be?
Dr. Goodman. Well, I would say we take any problem as a
significant problem, and if you look at the fact, as you
mention, that people can have the virus in their blood without
having symptoms, we take that seriously. But right at this
time, what we have is a few case reports under intensive
investigation, some of which may represent this kind of
transmission. But we are behaving as if they will show that
this could occur and that we need to be prepared and
potentially screen the blood.
One opportunity I would like to take, and perhaps Dr. Fauci
or Dr. Gerberding would comment also, is that we were, or Dr.
Fauci was asked earlier to put this in perspective with AIDS,
which I think raises very important concerns and legitimate
concerns when people hear about a disease that might be
transmitted by blood, where this was such a problem for AIDS.
With West Nile Virus, there is a major important difference
here, and that is that the currently available science would
suggest that this virus is only in the blood for short periods
of time in a donor. The donor then clears the infection. So it
is not as if there is a reservoir of folks walking around
chronically for months, years, lifetime with this in their
blood. So that is an important distinction.
It does not mean that we do not need to take this
seriously. And again, my point of view is, yes, we need a lot
more information to know the degree of the risk, but while we
are getting that information, we want to respond as if this
risk were serious and significant and may require testing.
Senator Hutchinson. Let me just ask a kind of broad, open-
ended question. Is there any tool or any additional authority
that CDC should have in order to combat West Nile Virus?
Dr. Gerberding. No. Our work in terms of controlling the
mosquito component of the infection is based on cooperation
with the State and local health officials. So the jurisdiction
for making decisions about what kind of intervention program is
appropriate are at the local level. We obviously are not a
regulatory agency, but we do have, I think, very effective and
supportive interactions with the public health community, and I
think right now, our technical support is respected.
The training that we provide has been well received. An
example of that is the fact that every laboratory, every public
health laboratory in the United States has been trained by CDC
to do the testing of the human cases, bird cases, and horse
cases of West Nile. We provide the reagents and we have been
able to document this year that that training has paid off,
because the labs are doing a terrific job.
So we have the capacity to get the job done right and I do
not think that our authority is the right limiting step in
this. I think it is really simply the fact that this is an
evolving epidemic and we do not know where it is going to go
Senator Hutchinson. Anybody else? Following up on your
comments, do you have any reason to suspect that different
strains of the West Nile might develop, and is the fact that
some victims suffer paralysis while others do not have a sign
that this could be a different strain?
Dr. Gerberding. We have been working on characterizing the
strains of the West Nile here in the United States since 1999
and comparing them to the strains that were involved in the
outbreaks in the Middle East and Eastern Europe. What we have
found is that, so far, all of the isolates that have been
characterized in the United States are extremely similar, if
not identical. So it looks like there is a single strain of
West Nile evolving here.
Of course, the most recent isolates from these cases with
polio-like illness and some of the other more unusual clinical
syndromes are not fully characterized yet, so we look forward--
that is one of our major research issues, is to do that strain
characterization and look kind of at the strains from the
standpoint of the illness that they create as well as the
geography where they are located.
The strains that are here now are very similar to the
strains that have been causing problems in Europe over the last
10 years, but not completely identical.
Senator Hutchinson. Thank you. My time is up. Senator
Senator Frist. I apologize. We have been voting, so we may
have covered some of these questions, but let me, while we have
the opportunity, just go through some things real quickly.
In Canada and Mexico, what is happening in these areas; the
maps kind of stop. Will the spread of West Nile Virus go
further south, or what will be the natural history of it?
Dr. Gerberding. There are cases reported in Canada, not
surprisingly, given the bird migration patterns and the summer
season there. We have one human case documented in Cayman Brac.
That is the only documented case in the Caribbean so far, but
the surveillance activities are just beginning to gear up in
that part of the country and we are concerned about places such
as Cuba or other areas in the Caribbean where we may not have
the information about the mosquito infection or the bird
infection the same way we do here, where----
Senator Frist. Is there a potential for greater West Nile
Virus spreading, place like Cuba, or as Senator Landrieu
mentioned, Louisiana, the mosquitoes are going to transmit the
virus year round. These areas could become a real haven for
this virus, and then this is going to get a lot, lot worse. We
do not have the controls; we cannot do the outreach; we cannot
educate for the prevention. Obviously, you examine the history
of malaria, the third biggest killer in the world, and its
relationship to mosquitoes, to determine if we should be more
concerned? What do we do?
Dr. Gerberding. There is a concern. I think as this virus
moves south through the Americas, we are alert to the fact that
other mosquito-borne diseases are extremely effectively
transmitted in Central America and South America. Dengue is one
of those mosquito-borne diseases which is a close cousin of
West Nile Virus infection.
What Dr. Fauci mentioned earlier, the mystery is, does
infection with something like dengue give you a little bit of
immunity to the West Nile Virus so that the population may be
less at risk, or is it just another serious infection that we
will have to add to the list? It is just too soon to tell.
Senator Frist. Dr. Goodman and Dr. Fauci, the information
on your slide that outlines the side effects of the smallpox
vaccine and the low incidence of really severe infection; that
information is based on data from earlier outbreaks. But, now
that we have 900,000 people who are HIV-positive. We have my
own profession of heart transplant in which thousands of
transplants are being done every year. Additionally, about
eight or nine million people who have cancer are either being
treated or already immunocompromised. Could it be that those
figures overall will be much higher, given today's population
is very different than when most of that data was generated?
You mentioned age, but if you could just paint that perspective
Dr. Fauci. The data of the 20 percent of people will
develop mild symptoms and one to 150 to 200 are really very
much in line with what we have seen from outbreaks in other
countries. However, each year, one can then go back after the
epidemic has essentially died down for the season and do sero-
surveillance studies and get a feel for how many people in a
given population were actually infected.
In fact, in New York, that very maneuver was accomplished,
where they went back and looked at when you had the original 60
cases with X-number of deaths. You go back and in that Queens
area of New York City that had the majority of cases, they
found that about 2 to 3 percent of the entire population had
been infected and they were able to then extrapolate that based
on the identified clinically apparent cases to give you that
ratio. We can easily do that by going back and doing
retroactive sero-surveillance studies.
Senator Frist. What are the three largest outbreaks in
history? Did you all go through the history of West Nile before
it entered the United States?
Dr. Gerberding. We have not mentioned it in detail, other
Senator Frist. I think it is worth mentioning. If you had
to look at the outbreaks, the first West Nile case appeared
when? How large was the outbreak? What happened in the Middle
Dr. Gerberding. The first case was documented in Uganda in
1937. I am not clear if that was associated with an outbreak or
not. I think it was incidentally diagnosed. And then in the
last 10 years, the largest outbreaks have been in Romania,
Western Russia, and in Israel. A particularly noteworthy
outbreak in Israel involved patients in a nursing home where
there was a very high incidence of the encephalitis and the
severe meningitis. So the largest outbreaks were clustered in
that area of Europe and the Middle East.
Senator Frist. Were there any long-term sequalae that
appeared 5 years later, 10 years later, or 20 years later?
Dr. Gerberding. We have studies ongoing now to follow the
natural history of infected people, but it is too soon to say
what the ultimate outcome would be. From the New York patients
in 1999, many of those who survived the encephalitis remain
with neurologic complications and fatigue syndromes and other
Senator Frist. Do these symptoms appear later or do they
appear as a sequelae of the disease, the acute disease?
Dr. Gerberding. Most of them had a continuum from having
the illness and never regaining a full recovery.
Senator Frist. Dr. Goodman, in organ transplantation, a
single organ donor, who is generous and unselfish enough to
having donated organs at the time of death, can transplant a
heart, a lung, another lung, a pancreas, a kidney, obviously
bone, tissue, eye, cornea, and help as many as 40 different
people, one donor.
Dr. Goodman. Right.
Senator Frist. And that is the beauty, and again, a plug
for organ donation.
Given that one donor can affect 40 people, is it not
incumbent upon us to have a crash course on how to screen that
donor? What are we recommending to the transplant community?
Right now, we screen donors routinely for HIV and for other
infectious diseases. Have there been any policy recommendations
for the transplant community, or are they being worked on?
Dr. Goodman. HRSA regulates the organ transplant testing,
but we have been working closely with them and I think many of
the same principles apply. I think you are right that this one
instance of this organ transplant donor and the four recipients
who developed infection is really the strongest case right now
and is of great concern, and you are also right that in many
cases, these people who choose to give this tremendous gift of
organ donation may also donate tissues for a very diverse group
of uses and that we are concerned about the potential for
spread of the disease through those.
So to summarize that, I think the same push to get a
practical, valid test which would allow us to screen blood is
extremely and directly relevant to tissues and we support it
for the same reason.
Senator Frist. Do I have another minute?
Senator Durbin. You certainly do.
Senator Frist. I want to just clarify this testing
business, if we can. Let us try to. Currently, there is a
serologic test and a polymerase chain reaction (PCR), and yet
there isn't a test for the blood supply.
Dr. Goodman. Let me try to be helpful on that.
Senator Frist. My goal is to clear up for my colleagues and
for people who are watching that when we say that there is not
a commercially available test to do all this mass screening----
Dr. Goodman. Right.
Senator Frist [continuing]. Which would be required to
ensure the safety of our blood supply.
Dr. Goodman. Right.
Senator Frist. Yet at the same time, we are making this
diagnosis in all the people who have either been exposed or
died from it. It is confusing to people that you have got a
test for diagnosis, and yet there isn't a test for the blood
supply. That being the case, how do we take the sort of testing
that you can do and be able to make it broadly available so we
can have these screens? What incentives--you say that is not
your business to actually commercialize it, but is there
something that we as policy makers can do to speed that process
Dr. Goodman. OK, a series of excellent questions. The first
one, which is covered in written testimony but I can answer now
here, too, is a real difficulty. Normally, the disease is
diagnosed in a clinical laboratory or a State or the health
department or the CDC through the presence in the blood of
antibody to the infection, an early form of antibody called
IGM. Now, that test is currently available and is being used to
diagnose disease all over the United States.
Senator Frist. Just so people understand, it is not the
Dr. Goodman. Not the virus itself----
Senator Frist [continuing]. It is the reaction to the
virus. You are measuring what the body--the normal body
response to the virus, so you are measuring that, not the
Dr. Goodman. Exactly. This is measuring the host response
in terms of producing antibodies to fight off the infection.
Now, when a host does that, they rapidly appear to clear the
virus from their blood.
So the problem from the issue of the blood supply,
potentially, or the organ donor is that those individuals are
unlikely to have antibodies in their blood. In fact, you could
almost argue, if they did, they are probably at very low risk
of transmitting the disease. So the same test that shows you
that you might have West Nile Virus does not, in fact, does not
correlate with showing you that you could transmit it to
And so in order to detect a risk for a blood or organ donor
to transmit an infection to somebody else, you have to find
direct evidence of the virus itself, not of the person's
response to the virus because it is too soon. And as you
mention, the technologies for doing that have predominately
revolved around techniques which detect tiny amounts of the
genes of the virus and amplify them to a level where they can
be detectable. PCR, polymerase chain reaction, is one that is
commonly utilized. There are other forms of nucleic acid
These tests are more complex, more technologically
demanding, but on the positive side, we have succeeded in
putting those kinds of tests in place to further reduce
tremendously the risk of HIV and hepatitis C transmission in
the blood to the order of less than one in a million or one in
two million at this time. So I think we are optimistic that
some of this technology is adaptable.
Senator Durbin. Thanks, Senator Frist.
Dr. Goodman, I am sorry to hold the panel, but I want to
follow up on that question, because earlier when we asked you
about the blood supply, if I understood your answer correctly,
you said we do not have a validated test at this point. Perhaps
in a year, we might. We talked about the incentive for creating
a mandate or a requirement for the test so that private
industry, the private sector will respond with a test that we
can use. Then you went on to say that you were considering new
questions when it came to blood donors and you said if people
exhibited flu-like symptoms, that might be an indicator of at
least some concern or caution.
But I thought in just responding to Dr. Frist--Senator
Frist and Dr. Frist at the same time--that you said if a person
is asymptomatic, if they do not show any flu-like symptoms,
they may still be carrying the West Nile virus, because the
antibody is in their system.
Dr. Goodman. Right.
Senator Durbin. So asking the question if they do not have
any flu-like symptoms does not take us very far in terms of
Dr. Goodman. Right. These are different components of steps
to try to protect the American people from any risk here. One
is to protect people through the donor questions and calling
back if people have symptoms who may have infection and may
manifest symptoms. But you are absolutely right. Another
concern is the patients who do not have or never develop
symptoms, and for those, a procedure such as testing the blood
is what would be needed.
This also connects to Dr. Frist's question. But with
respect to the incentive to the industry, etc., as I said, the
message I am getting is that they are taking this seriously and
proceeding full steam ahead. We are doing everything we can to
push that level of preparedness and to do as a regulatory
agency everything we can to facilitate that development. But in
the end, the issue of the motivation and the performance of the
industry is probably best addressed with them, but I have a
positive perception so far.
Senator Durbin. Thank you very much. The Senators who have
arrived have said that they will save questions for the second
I want to thank this panel and I want to make certain that
what was said here is understood clearly and that I understood
clearly, in that from Dr. Fauci, though we are not talking
about a public health threat of the magnitude of the flu
pandemic or AIDS disease, in your words, it is not trivial and
must be taken seriously. You anticipate, and I hope you are
right, a decline in infections and deaths next year from this
problem. Is that fair?
Dr. Fauci. It is possible that that would happen. There is
certainly no guarantee. But if it acts like other flaviviruses
have where there has been waxing and waning, we can expect,
maybe not next year, that there will be a waning. It is unusual
that you would see this, but we are prepared for that
Senator Durbin. And as far as a vaccine, a human vaccine,
you say on an expedited schedule, 3 years is the likelihood of
producing such a vaccine.
And Dr. Gerberding, what you have told us is local units of
government and health agencies are going to need help in
dealing with this mosquito-borne illness in terms of financial
assistance. The $29 million this year has been helpful, but
more will be needed in the future to deal with it, is that
Dr. Gerberding. Yes.
Senator Durbin. Thank you very much. Dr. Goodman, Dr.
Fauci, and Dr. Gerberding, thanks for joining us.
Senator Durbin. Now we will move to the second panel. I
will introduce them as they are being seated, in the interest
of time for my colleagues.
Dr. Sidney Houff is here. He is the Professor and Chairman
of Loyola University, Chicago's Department of Neurology. He
will discuss the steps health care providers are taking to
identify infections associated with the West Nile Virus, treat
them, and educate the public about risk factors. In addition,
he will outline how serious the threat is to humans, and the
methods currently being used to treat the illness associated
with the virus.
Dr. John Lumpkin, my friend and an outstanding public
servant in the State of Illinois. We had a similar panel in
Springfield in August. I am glad you are here today. Dr.
Lumpkin is the Director of the Illinois Department of Public
Health and will outline our State's current efforts, as I
mentioned before, to control the spread of a virus which has
hit us particularly hard.
Then we are going to have Dr. Fay Boozman, Director of the
Arkansas Department of Health, to discuss additional challenges
that State officials face when responding.
And we have one other witness, whom I will ask Senator
Landrieu to introduce.
Senator Landrieu. The witness from Louisiana is Parish
President Nickie Monica, who represents a parish right outside
of New Orleans, actually between New Orleans and East Baton
Rouge. Nickie has done an outstanding job in keeping the
mosquito population down by putting in place a very effective
eradication program that is both safe and effective.
We wanted him to share his insights, Mr. Chairman, because
as much as we would like to have a vaccine, screening, and
testing, I think our parishes and counties need some help with
instituting appropriate kinds of spraying and pesticides
programs that are so effective in preventing the spread of West
Nile and the public feel safer. He is here to testify about
that. Thank you, Nickie.
[The prepared statement of Senator Landrieu follows:]
PREPARED STATEMENT OF SENATOR LANDRIEU
I would like to begin by thanking the Chairmen and the Ranking
Members of both of these committees for holding this very timely
hearing. The recent outbreak of West Nile has demonstrated not only
that we have learned a lot since our first experience with this deadly
disease in 1999 but also that we have yet a lot more to learn. I am
especially proud to be joined this morning by Nickie Monica, Parish
President of St. John the Baptist Parish in Louisiana. Mr. Monica, and
all of Louisiana local officials, have really been at the front lines
in this war and have a great deal of insight to offer, especially in
the area of mosquito abatement, a subject we are all too familiar with
in my home state.
Mr. Chairman, as you know, the State of Louisiana, along with many
other states, have for the past several months been under siege. The
enemy is small, but powerful, and great in number. Hard to detect, they
sneak up on you and with one attack, they can change your life forever,
because they carry with them a deadly weapon to which we have little
defense. To date, 11 Louisianans have lost their lives in our war
against mosquitoes and the West Nile Virus that they carry and 261 more
have been made ill, In Baton Rouge, our state capital, 42 people have
been reported to be infected with the disease and three have died. Only
Illinois, with 473 human cases and 25 deaths, has experienced more
casualties from the virus than Louisiana.
In 2000, the Governmental Affairs Committee, under the direction of
my esteemed colleague Senator Lieberman, did a study of our Nation's
response to the first recorded outbreak of West Nile in the Western
Hemisphere. While their ultimate conclusion was that local, state and
federal officials had acted with the speed and skill necessary to
control the outbreak, doing so required that they overcome a series of
barriers that inhibited them in many ways. Our recent experience in
Louisiana has demonstrated that many of these barriers still remain. I
will touch on three remaining barriers here this morning.
Throughout the history of Louisiana, spraying for mosquitoes and
dredging the water they breed in has been a common occurrence. Until
now, however, it was done because mosquitoes were pests and they could
carry deadly germs. Now, our state and local officials are spraying
around the clock in a desperate race to control the worst outbreak of
West Nile the Western hemisphere has ever seen. There is no specific
treatment for West Nile, nor a vaccine. The most effective way to
protect our citizens against this deadly virus is to stop it before it
I recently introduced legislation, along with members of my
delegation, that asks for federal assistance for states to ``M.A.S.H.''
out this predator and stop the spread of this disease. I think that is
clear that there is an urgent need for this bill to become law. If
passed, it can have an immediate effect in saving on the lives of
people in my state and throughout the nation. One might think that
funding of this type is already available, but it is not. In fact, the
$3.4 million that Louisiana received from the CDC this August was
specifically directed at other purposes such as treatment, public
awareness campaigns and testing. What's more, this funding is given
from the federal to the state government and is often inadequate to get
to down to the local level, where it is arguably needed the most.
I want to be clear, however, that this legislation is not an effort
to supplant state's responsibility in this area, but to supplement it.
Our state has and will continue to dedicate a great deal of state and
local resources toward ``Fighting the Bite.'' On September 5, 2002, the
State of Louisiana began distributing $3.4 million in state funds to
support the local governments in their efforts to combat West Nile. The
Department of Health and Hospitals is spending over $200,000 on a
public education campaign asking people to do their share to avoid
leaving standing water and other mosquito havens. Two-thirds of
Louisiana's population is covered by an active mosquito control program
and those without mosquito control programs are using spray trucks
provided by the Louisiana Department of Agriculture and Forestry.
The second barrier is somewhat related to the first. Our Nation's
first experience with the West Nile Virus taught us that effective
treatment and prevention of this deadly disease requires coordination
among the many federal agencies with expertise and jurisdiction in
outbreaks of this kind. The formation of a West Nile Virus Coordinating
Committee, chaired by the CDC and composed of representatives from
USDA, the United States Geological Survey's National Wildlife Health
Center, the Environmental Protection Agency, FEMA and the U.S. Defense
Department was a first step in this direction. These efforts must be
strengthened and pushed beyond just the walls of the Coordinating
Committee. An effective response to this disease not only requires the
advice, but the resources and personnel, that can be balled upon by all
of the agencies represented on the Coordinating Committee. I urge this
committee to explore ways that we can improve the coordination of these
federal agencies and their sate and local counterparts.
Finally, as the committee recognized in 2000, the United States
public and animal health communities remain divided culturally and
organizationally. This divide continues to raise serious public health
concerns, especially in prevention and treatment of diseases that are
transmitted from animals to humans, such as West Nile. Dr. Maxwell Lea,
Louisiana's state veterinarian, has reported to us that well over one
hundred horses are confirmed to have died from the disease. He also
reports that several times this many deaths have gone unreported. Often
times the greatest number of livestock deaths coincided with the level
of human incidence. I would suggest that we explore ways to bridge this
divide so we can stop the spread of the disease before it results in
death to humans or the livestock they depend on.
Mr. Chairman, thank you again for the opportunity to be here and to
participate in this hearing. I am very proud to represent the citizens
of the Great State of Louisiana who, I think you will agree, have done
a tremendous job under extreme pressure. On behalf of them, I thank you
for your continued work in this area.
Senator Durbin. Thanks, Senator Landrieu.
At this point, under the rules of the Senate Governmental
Affairs Committee, I will ask you all to please rise for the
Do you solemnly swear the testimony you are about to give
is the truth, the whole truth, and nothing but the truth, so
help you, God?
Dr. Houff. I do.
Dr. Lumpkin. I do.
Mr. Monica. I do.
Dr. Boozman. I do.
Senator Durbin. Let the record indicate that the witnesses
have answered in the affirmative.
I am sorry, Senator Hutchinson. I thought you had left, but
would you like to say a word about Dr. Boozman before they give
Senator Hutchinson. Mr. Chairman, I would only rarely
correct you, but his name is pronounced Boozman.
Senator Durbin. Boozman, I am sorry.
Senator Hutchinson. Dr. Boozman is our Director of the
State Department of Health in Arkansas, is doing an outstanding
job, and is a very dear friend of mine and we are glad to have
him on our panel today. Thank you, Mr. Chairman.
Senator Durbin. Thank you.
Dr. Houff, would you like to be the first to testify?
TESTIMONY OF SIDNEY ANDREW HOUFF, M.D., PH.D.,\1\ PROFESSOR AND
CHAIRMAN, DEPARTMENT OF NEUROLOGY, AND DIRECTOR, NEUROSCIENCE
AND AGING INSTITUTE, LOYOLA UNIVERSITY MEDICAL CENTER, MAYWOOD,
Dr. Houff. Mr. Chairman, Members of the Committee, I want
to thank you very much for the opportunity to be here today. I
am not only the Professor and Chair of Neurology at Loyola
University, but I would like to tell you that I am the Chair of
the Steering Committee for the Conservation Medicine Center of
Chicago and the Director of the Neuroscience and Aging
Institute, and I think those are important because the
Conservation Medicine Center is a collaborative effort between
Loyola University, the Brookfield Zoo, and the University of
Illinois, bringing a consortium of veterinarians, physicians,
and so forth together addressing this sort of problem.
\1\ The prepared statement of Dr. Houff appears in the Appendix on
I would like to divide my testimony up into two aspects.
One, I would like to give you a clinical impression of what
these patients are like. I have had the privilege and the honor
of taking care of them, and give you some idea of what we are
facing in the human area, and then speak to you as a
neurovirologist and someone responsible for designing and
implementing studies of these kinds of illnesses.
First, I would like to let you know that us in the medical
community are privileged and pleased with the response of the
CDC and State health departments. The response has been
tremendous. It has been very informative and efficacious for us
as physicians taking care of these patients, and I think that
the congratulations and debt of the medical community to these
groups has been well founded.
As far as the clinical aspects of this disease, it is my
opinion we have seen some changes in the clinical
manifestations of this disorder. In the past, the neurological
complications have been mainly meningeal encephalitis, that is
an inflammation of the brain, and the meninges, the covering of
the brain, with very little seen in what we call focal
neurologic deficits, that is, the deficits that cause paralysis
or those sorts of things.
In the beginning in 1999, we did see what was called
Guillain-Barre-like illness, where people became profoundly
weak with muscle pain. But in this episode, or this epizootic,
what we have noticed is focal neurologic deficits have been
more common. Now, whether that is going to hold up true at the
end of the epidemic when we look at all the cases, I do not
know. But certainly in our experience in Chicago, that has been
a prominent finding, that we have begun to see patients with
optic nerve disease and blindness, anterior horn cell disease
and paralysis, Parkinson's-like syndromes, and so forth during
the acute illness. So that really strikes to us as a change in
the clinical picture may be occurring as this epidemic evolves
over the years.
As far as treatment goes, as you know, it is very limited.
We only have supportive therapy at the present time. We use
steroids to reduce brain swelling, we use seizure medications
to prevent seizures, and we support the patients.
Unfortunately, as you know, that is not always possible to do
and we have had deaths, both at Loyola and other institutions
As far as treatment, you have heard from Dr. Fauci what
lays on the future. One of the things that I would emphasize is
the possibility of using immunoglobulin therapy, gammaglobulin
therapy, and antibody therapy for this. We do know in
neurological diseases in the past we have been successful with
that. For instance, in enterovirus like polio, we have been
able to treat patients who have low gammaglobulin levels
successfully with this type of therapy.
And in Israel, there is at least one case that I am aware
of that has been treated with serum containing high antibodies
to West Nile Virus and the patient survived. Whether that was a
direct effect or not, I do not know. But certainly, that is
something that one could address quickly and bring to the
forefront in a short period of time as a way to address a
Switching gears and talking about what we do not know about
West Nile Virus and what I think would be a reasonable approach
in the future, I think that Illinois has a very interesting
history that may be quite illuminating if we approach it
correctly. As you know, Illinois was faced with the St. Louis
encephalitis virus epidemic in the 1970's which was quite
severe, and as you heard earlier, the St. Louis encephalitis
virus and West Nile Virus are both filioviruses.
So one of the questions I think that it behooves us to
address in the future is what is different here? What in the
enzootic, what animal species, what avian species are infected,
what mosquito species are infected, and why in this environment
do we face so many animal cases and so many human cases? I
think that Illinois offers us an opportunity to address those
issues. With that in mind, the Conservation Medicine Center of
Chicago is now looking into designing studies to address those
issues, both in the animal population, the insect population,
and in the human population.
Finally, I would like to address surveillance because I
think this epidemic illustrates what we are up against. We have
done a fine job at identifying things and identifying West Nile
Virus and plotting its development, but one of the things we
have done over the years is close many of the surveillance
centers around the world. As jet travel and human travel
between countries has increased, we have decreased our
surveillance efforts around the world, and I would encourage
people who have the opportunity and the ability to think about
reopening those to address emerging infections.
Senator Durbin. Excuse me, Doctor. Could you be specific?
When you say surveillance efforts, what are you talking about?
Dr. Houff. Yes, sir. I will be glad to, Senator Durbin. The
Rockefeller Institute, for instance, has centers around the
world that monitored arbovirus infections, infections that were
transmitted by insects and so forth, and those were closed as
the years went by and they are not available anymore. So what
we do not know is how are these viruses circulating in nature
in other areas.
One of the questions that came earlier this morning was do
we know whether West Nile Virus circulates in the United States
in animal populations and humans as it does in Europe and the
Middle East, and although we think we do, the actual studies
that we need to do to address those issues specifically have
not been done and need to be done. If you look at the epidemic
in Israel, for instance, and the United States, we have had
high avian die-offs in both. The Romanian epidemic was not
associated with that, nor were any other West Nile Virus
infections that I know of. So these surveillance centers, I
think, are very critical for the future.
Senator Durbin. Thank you very much, Dr. Houff.
Dr. Houff. Thank you, sir.
Senator Durbin. Dr. Lumpkin.
TESTIMONY OF JOHN R. LUMPKIN, M.D.,\1\ DIRECTOR, ILLINOIS
DEPARTMENT OF PUBLIC HEALTH, SPRINGFIELD, ILLINOIS
Dr. Lumpkin. Thank you, Mr. Chairman, and thank you for the
opportunity, and the Members of the Committee, to speak and
talk a little bit about our experience in Illinois.
\1\ The prepared statement of Dr. Lumpkin appears in the Appendix
on page 67.
Illinois, as you know, is one of the most severely impacted
States in the Nation. As of today, we will be reporting in the
neighborhood of 520 cases. There was at least one additional
death we will be reporting today, which will bring our total up
to 28. This obviously has had a tremendous impact and it is not
a trivial outbreak.
Our experience in Illinois began last year when we had our
first case of birds that was found to be positive for West
Nile. We have had an avian surveillance system that has been in
place. It has been in place since 1976. We, on average, collect
about 5,000 birds. We trap them live, we draw blood, and we
have been testing since that time. That surveillance system, as
well as the collection of birds and other animals, gave us a
heads up that we were going to have problems.
We have had in place plans to begin to address West Nile
through support from the Centers for Disease Control. Our first
plan was put in place in May 2001, prior to any cases in
Illinois, and then we developed a task force under the
direction of the governor of State agencies that began to put
our plans in place for this spring.
Our first case amongst birds was found in May. We saw an
outbreak that really moved fairly slow until mid-July, in which
case there was an explosive outbreak amongst the birds. In many
neighborhoods, particularly in the Chicago area, it has been
called the ``silent summer'' because birds have not been heard
in many communities. There really has been a dramatic impact
upon the bird population.
In response to this and with the subsequent human cases, we
began to use State resources. We had made grants to local
health departments to develop plans prior to the human cases,
but afterwards, $3 million of State funding were made
available. This has created certain problems for us, because as
we have looked at how to address the resources that we have
available, and with the State, like many other States, having
severe budget restrictions, we have essentially had to use
money that currently would be available to local health
departments to do food inspections, infectious disease control,
inspections of water and sewage systems, and so we have had to
dip into that fund and spend money that we really do not have
in order to respond to the West Nile.
We are currently engaged in activity. This $3 million has
been granted out to counties throughout the State that have had
human cases. We have been focusing on doing larvaciding as well
as integrated mosquito control. This integrated control has had
an impact. We believe that our outbreak obviously would have
been much worse had we not been able to do this sort of
I would like to talk about one issue that was raised and
one that is a concern. We have a number of things in place in
Illinois, surveillance and our response plan, basically because
we responded to an outbreak in 1975. Since that time, many of
the mosquito abatement districts at the local level had seen
significant reductions in resources. We as a Nation and many
communities tend to forget the lessons that we have learned
from the past, and as such, it became incumbent upon the State
to make resources available to local communities when those
communities exhausted the resources that were available at the
But an important question, I think, has to be raised.
First, do we really understand this disease and are we
conducting studies in all the ways that we should? The first
panel talked about research that is going on in humans. I
wonder whether or not we are doing adequate research among the
avian population, the major reservoir. Do we fully understand
this? What will be the pattern? I do not think the answer will
be in people. I think the answer will be in birds. What is
their experience? Why are we seeing such a large bird die-off?
The second is that when you look at the cases in Illinois,
three-quarters of the cases in Illinois are in Cook County.
Over half of those cases are in two distinct locations, the
exact same locations that we had a major number of cases in
1975 in our St. Louis encephalitis outbreak.
Senator Durbin. Which locations are those?
Dr. Lumpkin. That is the Southwest side, mainly focused
around the Oak Lawn area, Evergreen Park, Beverly, Morgan Park,
that area, and on the North side, sort of focused around
Skokie, dipping into the city in that area.
I think that there is reason to do intensive study of those
communities to find out what in particular is about the bird
population and the mosquito population that leads to the
recurrence of this particular outbreak so severe in a virus
that is very similar to St. Louis encephalitis. I think we
missed an opportunity to do that research in 1975 and we should
not miss that opportunity to do that research this year because
of the severity of the outbreak.
We are looking for assistance from the Federal Government.
I think we have had a fair, a good bit of assistance in the
past, but we need to have additional research to better
handle--give us the kind of tools. Some of the tools that we
need, for instance, are how we conduct our bird surveillance.
We collect blood samples from wild birds. I do not think we
have adequate reagents to be able to test them as a very early
warning system to be able to determine whether or not West Nile
Virus exists in those bird populations. Understanding more
about the biology of West Nile in the bird population is worth
additional research, and as well as resources should be made
available to the States and communities to better respond.
Senator Durbin. Thanks a lot. Mr. Monica, thank you for
TESTIMONY OF NICKIE MONICA,\1\ PARISH PRESIDENT, ST. JOHN THE
BAPTIST PARISH, LaPLACE, LOUISIANA
Mr. Monica. Mr. Chairman, Members of the Committee, I am
Nickie Monica, Parish President of St. John the Baptist Parish,
and resident of the suburb of the New Orleans metropolitan
area. St. John's population is near 50,000 residents and is one
of the fastest growing areas in the State of Louisiana. St.
John is located on the Mississippi River, which has a
substantial industrial job base that has brought significant
economic development and higher than average wages to our area.
\1\ The prepared statement of Mr. Monica appears in the Appendix on
It is indeed a pleasure to appear before your Subcommittee
to shed some light on the growing local problem that has
national implications. Just a short time ago, mosquitoes, like
many other insects, were just another nuisance that interrupted
the outdoor life of our residents. Unfortunately, it has now
been thrust into the national media because it has become a
serious health hazard, with devastating consequences to many
families around this country, including those in my State of
Fortunately, Mr. Chairman, St. John Parish has not yet
experienced a human fatality, something I believe is due to our
proactive measures to combat this growing public menace.
However, if a more prominent effort is not put forth, I am
fearful that it is just a matter of time before tragedy strikes
St. John the Baptist Parish initiated its own regimented
mosquito control program over a decade ago. That was an added
quality of life issue for our residents. This program is run by
professional and licensed entomologists who are experienced in
the field of surveillance and treatment. Our spraying and
treatment program experienced no problems until the West Nile
Virus began approaching Louisiana from the East Coast States.
We immediately allocated 30 percent more funding to the
spraying program without additional surveillance. We also began
a public awareness campaign to encourage residents to minimize
the threat of larvae hatchings around homes and businesses.
Additionally, the Louisiana Department of Health and Hospitals
initiated statewide public service announcements reminding all
residents to be vigilant and lessen the threat of infection. It
is my opinion this has been effective in itself.
Even though St. John the Baptist Parish has an adequate
control program in place, our financial ability to continue to
fight over a sustained period of time is practically exhausted.
We all know this problem is not going away. The question is how
best to fight and fund an effective program. The fact that
parishes and cities that do have a program also have West Nile
Virus, that is of great concern.
Mr. Chairman, I know my own parish and State best and have
thoughts on how to provide a remedy to abate danger. We now
have to look to the experts to tell us what is best, the best
protocol that could be implemented statewide. It is definitely
more than a local program. It is a national and State health
concern, and the Federal Government does need to play a major
role in fighting and funding. Of course, any Federal program
must be consistent statewide in order to maximize abatement
Mr. Chairman, I also want to thank the Louisiana
Congressional delegation and the U.S. Congress for their
efforts to assist Louisiana and the rest of the affected areas
of our country in this effort. For example, further Federal
assistance should immediately begin to provide rapid processing
of bird and mosquito specimens submitted for virus testing, and
that would be made possible by the Mosquito Abatement for
Safety and Health Act, S. 2935, as introduced by Senators
Breaux and Landrieu. The legislation could allow State and
local governments to react more rapidly by providing funding to
existing programs and States.
Too much time has been lost in reporting results that could
further direct control efforts. The point of surveillance is to
detect the virus before it spreads to the human population.
When weeks are required to report results, the advantage of an
early warning system is lost. Consequently, immediate
preparation and funding are needed to allow State laboratories
to continue testing dead birds submitted by citizens even after
the virus activity has been detected in a particular parish or
county. The additional data is vital in determining the exact
location of the virus, which, in turn, allows more direct
assignment of abatement resources.
The Congress should also continue emergency funding for
expanded surveillance, for testing, and for State laboratories,
which will play a role in early detection of the virus. My
parish needs assurances that emergency supplemental funds will
be made available for additional mosquito control efforts
should West Nile or any other mosquito-borne disease require
response beyond our local capabilities. This becomes
particularly important when disease is coupled with storms or
manmade catastrophes that stretch available resources beyond
Mr. Chairman and Members of the Committee, this concludes
my testimony. It was indeed a pleasure to be able to convey my
thoughts on an important issue and a growing national health
problem that will require a unified effort. I want to thank
each of you for your participation and I will be available to
answer any questions. Thank you, Mr. Chairman.
Senator Durbin. Thanks, Mr. Monica. Dr. Boozman.
TESTIMONY OF FAY W. BOOZMAN, M.D., M.P.H.,\1\ DIRECTOR,
ARKANSAS DEPARTMENT OF HEALTH
Dr. Boozman. Thank you, Mr. Chairman and Committee. I
appreciate the opportunity to share with you. I have been very
appreciative of the experts that have been testifying to you
because they are the same experts we depend upon to guide us.
But I feel like the report I am going to give you is somewhat
of a blue collar report in the sense that while vaccines are
being developed and these very important questions that you
have been asking are being looked at, we are faced on a daily
basis with people contracting this disease and a need to deal
\1\ The prepared statement of Dr. Boozman appears in the Appendix
on page 70.
I want to thank our partners at the CDC. They have been
outstanding in giving us funding and being as flexible with
that funding as they can be and helping us to meet this crisis.
They have been excellent in helping with our surveillance, our
laboratory, and the other things, and I think that money that
you have already spent was wisely spent and has done an awful
There has been a lot of talk in the testimony about next
year, and I certainly do not speak from any scientific
perspective. I am just looking at what has been happening. This
has gone down the East Coast. It is coming from the North. As a
State health officer, I have to think we are going to have a
bad year next year. The year we are having this year is very
much like the year Louisiana had last year and the disease
burden is just growing. The virus burden is clearly growing.
Last year, we had four birds. This year, we are up in the
hundreds of birds.
And so I feel like that we have got to build on the
knowledge we have. As new knowledge is being developed, we have
got to build on the knowledge we have. We know that larvaciding
works. We know that getting rid of standing water and places
where the mosquitoes can breed, education in those areas works.
Recently in Pine Bluff, Arkansas, which is our focal area,
where we have the most cases, they had a community clean-up and
the county judge told me that they did not pick up a single
tire in that county that did not have growing mosquito larvae
in it when they picked it up. So there are things that can be
done that we need to be doing right now that we know needs to
be done while we work out some of these very important
In Arkansas, we estimate that a good comprehensive,
integrated program of education, larvacide, and then in those
areas where we have significant human cases, adulticide, would
cost in the neighborhood of about $5 million. This year----
Senator Durbin. Excuse me, Doctor. You used the term
Dr. Boozman. Yes, of the mosquitoes, the adult mosquitoes,
This year, our governor released out of his emergency fund
$1 million, which we specifically just used for larvaciding.
Larvaciding, I think, is the most efficient and most cost
effective and safest in terms of a way to help control the
I think we certainly need to continue the surveillance
activities that have already started. As Senator Frist
mentioned in some of his questions earlier, there is an awful
lot of overlap as we prepare for this with our preparations for
bioterrorism. In fact, as we have responded to the West Nile,
through our communications, through the many different things
we have done, I think it has made us much better able to
respond to a bioterrorist event. I think it is money that is
actually having a good dual purpose. As our surveillance gets
better for West Nile, it gets better for everything else, also.
I think we have clearly seen that we have got to continue
to invest in the capacity of our public health laboratories. We
saw it with anthrax and it has just been amplified with this,
that we do not have the capabilities at the State level right
now. There has not been much investment in public health
laboratories for many years, and as a result of that, we need
to continue to increase their capacities.
So in conclusion, Mr. Chairman, I think we must continue
the funding that has been going on in surveillance, the
additional funding we got that allowed us for the education.
But I think there has got to be some additional funding for
vector control of these mosquitoes. And also, though we have
had some funding, I think there has to be a continued emphasis
on getting our public health laboratories into shape. Thank
Senator Durbin. Thanks, Dr. Boozman.
Let me first ask of Dr. Lumpkin, you have focused on two
areas in the Chicago area which may be beyond our parochial
interest, since we are from the same State, and you indicated
that the incidence of St. Louis encephalitis in these same two
areas where you are seeing the prevalence now of West Nile
Virus infection is worthy of investigation. Could you follow up
a little bit on the 1975 that you referred to, was there a
similar situation with the death of the bird population, the
Dr. Lumpkin. I am not aware that there was a similar death
of the avian population, but I think we heard earlier testimony
there were roughly 1,000 or more cases of St. Louis
encephalitis that year. Almost 600 of those were in Illinois,
and there were 47 deaths. So it was the most intense experience
of St. Louis encephalitis.
Senator Durbin. Mosquito-borne?
Dr. Lumpkin. Mosquito-borne, intensified in birds. The
difference between West Nile and St. Louis encephalitis is the
West Nile Virus replicates much more rapidly than St. Louis
encephalitis. So many of the conditions between West Nile and
St. Louis encephalitis are very similar. So if we had an
intense experience in 1975, why? And if we have the same
intense experience with a similar kind of vector-borne, same
mosquitoes and birds, why again?
What we learned with basic epidemiology is you identify the
population that appears to be most at risk and you study them
intensely to see if you can learn the kind of lessons that then
become applicable to the general population, and we believe
that would be the case in the areas that are intensely involved
Senator Durbin. I think that is worth following up, not
just for our own protection, but perhaps for the lessons
learned for other parts of the country.
I just looked. Back in July, we announced some money
through the Department of Agriculture for the State of
Illinois, $750,000 to deal with this. At the time, I noted in
my press release, I made a point that there had not been a case
of human infection as of July 26 of this year, and here we are
with, I believe, hundreds of cases of infections, including an
incident with a young intern on my staff who went down to the
Illinois State Fair in Springfield, came home not feeling well,
and we thought she had meningitis. That was the first diagnosis
when she--she is fortunately a young, healthy woman and went to
the hospital for 2 or 3 days, came back, felt better,
recovered. Two weeks later, they told her she was a victim of
West Nile Virus which she did not realize. But now, in that
short span of time, there have been 27 or 28 fatalities in our
Let me ask you the question which continues to come to
mind, and I would like Mr. Monica or perhaps others to respond
to it. What is the trade-off here? When we start using
larvacides, insecticides, adulticides, what is the downside, if
there is any? Is there a danger associated with spraying these
chemicals and the impact it might have on public health or the
public water supply as opposed to the danger of West Nile
Virus? How do we balance these and come to the right
Dr. Lumpkin. Well, West Nile Virus, getting West Nile Virus
comes down to the numbers. In areas where there have been an
intense experience with West Nile, roughly one out of 200
mosquitoes will carry West Nile Virus. And for those who are
bitten, one out of 150 will get the severe form. So those odds
are about one to 30,000 mosquito bites. The best mosquito
abatement can reduce the mosquito population by 50 percent.
Senator Durbin. Fifty?
Dr. Lumpkin. Fifty percent. So you now reduce the risk
because you are reducing the number of mosquito bites. So when
you start to see that you are having transmission, you need to
use all your tools. The first tool is larvaciding. You kill
them. You prevent them from hatching into adults so they cannot
go around and bite the birds and bite people. Once you begin to
have intense experience, as we have done in these two areas,
then we use adult spraying, so the combination of the two.
We do not support nor do we fund adult spraying only. Adult
spraying will only have a short-term effect. It will last a
couple of days. Larvaciding lasts for weeks.
Senator Durbin. But I am asking you, is there a public
health risk to the larvacide and the adulticide and other forms
of mosquito control?
Dr. Lumpkin. Yes. The risk to larvaciding is very minimal.
It is a fairly specific chemical that is targeted to
mosquitoes. The risk for adult spraying, any kind of spraying,
because of particulate matter, may impact someone who has
sensitivity to the chemicals. But the studies that were done in
1999 in New York indicated that the risk from West Nile was
greater than the risk from the chemicals. And so I think we get
to the point when we begin to see human cases that the public
health equation says we take the risk for the better good and
we give public warning so people who may have those
sensitivities stay indoors.
Senator Durbin. In Illinois, we have focused on and made
certain that there is spraying in the two target areas that you
mentioned, the Skokie area as well as the Oak Lawn-Beverly-
Evergreen Park area?
Dr. Lumpkin. That is correct, and then there is focused
spraying depending upon bird surveillance and mosquito
surveillance around the State.
Senator Durbin. Thank you.
Mr. Monica. Mr. Chairman, I have a comment.
Senator Durbin. Certainly. Mr. Monica.
Mr. Monica. I think it is important to have a comprehensive
mosquito control program in place because, No. 1, you
larvacide, No. 2, our program, we set traps and we monitor the
traps and we collect the adult mosquitos and that is to
determine our spraying. But during dry periods, sometimes there
is no need to spray. So I think it is really important that we
come with a unified program, because mosquitoes and infected
birds do not know parish lines, county lines, or State lines.
So I think it is important that we develop a plan and unify a
plan and attack this problem. But having a comprehensive
program in place, I think, is what benefitted St. John Parish
to this point.
Senator Durbin. Thank you. I have another question of Dr.
Houff, but I want to let my colleague, Senator Frist, ask at
Senator Frist. Thank you, Mr. Chairman.
Dr. Houff, I stepped out while your oral presentation was
made. Could you comment on what we were talking about earlier
in terms of the immunosuppressed patient or the
immunocompromised patient in any way, whether it is from age or
it is from immunosuppressants for transplantation or cancer
therapy. Does this population worry you more than the non-
immunosuppressed population in terms of manifestation or ease
Dr. Houff. Yes, sir, it does. I think that is an excellent
point. One of the things we do not know is what is the host
immune response? What is the patient's immune response? Is it
just cellular immunity, hemo immunity, or the combination of
the two? It is likely the combination of the two.
We have seen West Nile in heart transplant patients, two
that I am aware of, and that population does worry me
considerably because, as you know, when those kinds of
individuals get infected, any kind of therapy you have is more
limited. We know that from a lot of different infectious
diseases. Once the patient is immunosuppressed, the antiviral
therapies we have, the interferons, whatever we have,
antibiotics, are not as efficacious. And so this population,
which is rising--I think you made that point earlier today, the
population of immunosuppressed patients rising with an
increasing number of birds dead and mosquitoes dead in urban
populations, where a lot of this disease and a lot of
transplants and so forth is done, is quite concerning.
Senator Frist. Have we talked about contagiousness of this
virus today? I am not sure if we brought it up, but did you
bring it up at all?
Dr. Houff. I did not bring it up.
Senator Frist. You might just comment on the risk for
person-to-person transmission. When we are talking the
bioterror agents, it is real clear. Anthrax, we finally made it
clear that it is not a contagious microorganism. Smallpox is.
Please comment on the ability to transmit West Nile from
person-to-person because I think the potential of this whole
hearing is to outline the impact in people's lives with the
first panel and, in the second panel, to outline our response
and whether we are behind the curve. But, if you could just
comment on that again for our edification.
Dr. Houff. Besides the discussions about blood and organ
transplants, I know of no human-to-human transmission of this
agent. As a caveat to that, I think one of the things that has
not been discussed this morning is the spill-over into other
mammals. The Illinois public health has reported squirrels and
dogs. That has been reported in the past. There have been a lot
of mammals reported in the past in some of these epidemics
around the world.
The critical factor is, they appear to not get enough virus
in the blood to be infectious for mosquitoes. But we do know
that lemurs in Madagascar, for instance, can transmit West Nile
to mosquitoes in nature, and there are some reptile species
that can transmit the virus to mosquitoes.
And so I think one of the emphases that we should do is
look at what are the mammal populations that has been infected
during this episode and what are the titers of virus in those
animals, because I think that may be a critical epidemiological
Senator Frist. I think it is important, and we have not
talked much about it today, that science really is being
developed broadly. I was at the Smithsonian Institution
yesterday talking to a range of people, and there is a whole
cadre of people working on transmission--experts in mosquitoes.
This whole issue of its spread by migratory birds is rather
complex, including determining what type of birds which can
spread the virus.
One of the Smithsonian researchers there, John Rappole, who
is at the CRC, Conservation Research Center, had written an
article in the Journal of Applied Microbiology. In that
article, he stated that the migratory birds historically have
not been a good candidate for transmission because the disease
had been moving much slower than expected. However, the
resident species might be a much better carrier.
I think it is going to be important as we look at spread
and its potential spread, we need to expand the science around
species and species transmission.
Dr. Lumpkin. In addition, I think there is one other
factor. The evidence related to the transplantation-related
cases and the transfusion-related cases brings up the whole
issue of people who are hunters. There is no evidence of
transmission by people normally in contact with animals, but
certainly there is reason to believe that it is possible to
have transmission if you are, in fact, in contact with blood
from an animal that has been recently killed. So the
recommendations that we have made and continue to make for
hunters, that they be careful when they are dressing down
animals, for West Nile and other diseases, still applies.
Senator Frist. Mr. Chairman, can I make one other point?
Senator Durbin. Sure.
Senator Frist. Dr. Lumpkin, I love your analysis, the one
in, is it 60,000?
Dr. Lumpkin. Thirty-thousand.
Senator Frist. Thirty-thousand mosquito bites. It puts it
in an overall perspective. Could you help me understand, what
is the bird doing? The bird is carrying the virus around. I was
at the zoo, which is part of the Smithsonian Institution, at
the end of July. While I was there, I had the opportunity to be
with the head veterinarian while he was making rounds.
While we were there, someone brought in a bird. That was
late July. That was before West Nile hit Washington, DC, and
before the birds were found on the Capitol grounds. While we
were making rounds to visit some of the other animals, someone
brought in a second bird that morning, and then a third.
Finally, it was clear that the birds were not from the same
area, but there was something killing the birds. We did not
know it was West Nile at the time. But with the test, it was
proven to be West Nile.
There is a transmission cycle that incorporates both the
mosquito and the bird. Does the titer, the level of the virus,
have to get high enough that the bird dies? Could there be a
number of birds flying around with West Nile, but only the ones
with a high titer actually die?
Dr. Lumpkin. I think it is even more complicated than that.
It depends upon the bird species. Certain species--crows, blue
jays--tend to be particularly sensitive to that. Other species
will get infected, they will develop a massive viremia, viruses
in the blood. Then they are bitten by multiple mosquitoes and
that sort of potentiates the cycle.
What I do not think we fully understand is to what extent
is the bird immune system part of the cycle that we see with
St. Louis encephalitis and maybe other arboviruses, so that the
experience in Illinois in 1975 was almost 600 cases in 1975, 19
cases in 1976. Could that have been also based upon some
developing resistance amongst the bird population and will that
have some impact upon West Nile? So I think we really need to
understand better the biology in the bird, which clearly is a
major player in this epidemic. It is primarily a disease of
mosquitoes and birds and occasionally humans get in the way.
Senator Frist. I have one more question.
Senator Durbin. Sure. Of course.
Senator Frist. This is switching gears. Currently, we are
giving horse vaccine to birds today. Is there any science that
the euine vaccine works for birds?
Dr. Lumpkin. My understanding is that a number of zoos,
including the Lincoln Park Zoo in Chicago, are experimenting
with the bird vaccine. I do not know that they have published
or they have had results yet.
Senator Frist. The issue that many of you talked to is this
whole idea of abatement. What is the appropriate Federal role
in West Nile Virus, is it in vaccine development, as we talked
about on the first panel? Does it relate to developing these
diagnostic tests--either through mandates, or incentives to the
private sector? Whatever it is, we have got to speed this
system up as we go forward.
Similarly, on this panel, the issue of abatement is a
critically important issue. That is on the front line. You are
right there where it really matters, up front, and we are going
to have to address it very soon. You are addressing the current
crisis, but we also must have a strategy for next year. As we
just heard, we do not know if this thing is going to get a lot
worse or a lot better.
Dr. Gerberding outlined the Federal role, and she stressed
the Federal role in planning, in counseling, in coordination of
activities. However, the local responsibility focuses on the
abatement because you are on the front line. You are the people
who are out there who can best plan for a local community and
who know what the needs are.
Then, there is the whole issue of resources. Is there a
Federal responsibility for additional funding, given the
increased funding through bioterrorism. As we all know, or as
has been said repeatedly, surveillance, detection, response,
communication, coordination is really hand-in-hand for both
bioterrorism and West Nile Virus. With that increased funding,
is it going to be redirected in some way for ``dual-use''
purposes related to West Nile?
That is going to be the debate that we are going to have. I
tend to come out that mosquito abatement is a local issue in
terms of support. But it is important that we use our Federal
responsibility to support that local abatement on the issues of
research, counseling, and coordination.
Just out of the interest of time, we do not need to go
through that issue, but it is one that I think we are going to
have to struggle with as we go forward.
Senator Durbin. Thank you, Senator Frist. Senator
Senator Fitzgerald. Thank you, Senator Durbin.
Dr. Lumpkin, thank you very much for being here. You have
really been on the front lines this summer dealing with the
terrible situation we have in Illinois. I was struck that in
your testimony you noted that about one-half of the cases in
Cook County are concentrated roughly in the Oak Lawn and Skokie
areas. You said that was the same areas that were most affected
by the early 1970's outbreak of St. Louis encephalitis.
Is there any tracking being done of the ethnic origin of
people who have had symptoms of the disease and then died from
the disease? Is there perhaps a common genetic link? Do you
think there is a missing gene in people who have died from this
Dr. Lumpkin. I do not think that we are in a position to
answer that question. Some days, we have had so many cases, we
have barely been able to determine the age and the county of
origin of those cases. I think that is something we will have
to look at over the winter.
Senator Fitzgerald. Are they tracking information about
everyone who succumbs to this illness?
Dr. Lumpkin. We are collecting information. I am not sure
to what extent we are collecting ethnicity. Certainly, race is
collected as part of our normal surveillance process.
Senator Fitzgerald. Is there something unique about the
geography in those areas? I know Skokie is near the Skokie
lagoons, although that is a little bit more to the east and
north, I think, of the Village of Skokie. Those lagoons have a
lot of water. It would seem to me that would be very good
breeding grounds for mosquitoes. But on the other hand, I am
struck that most of the cases are occurring in Cook County,
which is unquestionably the most paved-over section of our
State. I would think there would be a lot more mosquitoes in
rural areas than there are in Cook County, Illinois. You have
not drawn any conclusions, I gather, regarding where the
disease is occurring in relation to the topography or geography
of the area.
Dr. Lumpkin. Obviously, that is something we need to study.
When you look at the State, though, half of the people in the
State live in Cook County and the close-in Chicago area, so it
is not surprising. Again, when you look at the odds of one out
of every 30,000 mosquito bites lead to a severe case of West
Nile Virus, so if that is the case, more people are going to be
exposed to mosquitoes. And while we think about Cook County
being urban, one of the nice things about Chicago is that there
is a lot of open space and there is a lot of park space, and so
there is a lot of opportunity for mosquitoes to grow.
Unfortunately, though, the biggest problem, I think, with
mosquito control is trying to get the message out. We had an
entomologist up from the Centers for Disease Control the end of
August to begin to address some of these issues and the first
two homes that they went into, in the backyard, they found live
mosquito larvae in containers in the backyards. And so there
really needs to be a partnership between government and people
to remove the breeding grounds, to take individual precautions,
to make sure the screens are intact. This cannot be done alone
by government. It really has to be a partnership.
Senator Fitzgerald. We had very heavy rains this past
spring in Illinois, but then a fairly dry summer. That could
play a role, too, could it not?
Dr. Lumpkin. Certainly. In fact, the weather pattern that
we had this summer was very similar to the weather pattern we
had in 1975 and similar to the weather pattern they had in 1999
in New York.
Senator Fitzgerald. Illinois, at the end of the day, is
somewhat similar to Louisiana, the other most affected State,
in that we have a lot of standing water, and a lot of wetlands.
They have bayous down there, and we had more wetland before
Illinois was developed. But, we still have a lot today. I would
think that the quantity of standing water that we have would
make Illinois particularly vulnerable to infections that are
borne by mosquitoes and make it likely that we would have
mosquito control problems.
Dr. Lumpkin. I think it is a combination of factors, and
one of the issues that Senator Frist raised was about the
Federal-State role. Clearly, we need assistance in doing that
kind of research. We do not have the resources. We certainly do
not have the scientific capabilities of NIH and so forth. So I
think that is one of the things that we would really be looking
for assistance, in trying to answer those questions, whether it
be through satellite photos and analysis of the communities
that are most involved versus another community, a case control
study that way, as well as looking at issues related to the age
of housing, whether or not gutters are collecting water in
older communities. But why these communities and not the West
side, the Western suburbs? I think we ought to try to figure
Senator Fitzgerald. Dr. Houff, I was struck by your
testimony that stated we are seeing different symptoms now,
when the virus is present in a human, than we were a couple of
years ago. You stated that you are seeing more neurologic
symptoms. You described Parkinson's disease-like symptoms. It
has been reported that there are polio-like cases of paralysis
Do you think that when West Nile Virus first occurred on
the East Coast a couple of years ago, we just were not looking
for the virus as hard as we are today? Thus, could there have
been cases with the neurologic symptoms you are describing now,
but that they were not attributed to West Nile Virus? Or, do
you think the virus is actually changing and it now is a little
bit different than it was a couple of years ago?
Dr. Houff. With the caveat that what I said this morning is
going to depend on collection of all the cases at the end of
this and going back and looking, because obviously, this is the
prospect I am looking at, I think that the clinical picture has
changed and I do not think it is overlooking disorders in the
New York epidemic. Probably we did, but let me give you an
example of the negative.
In New York, clearly, paralysis and muscle pain was a
prominent feature. In fact, in April of this year, when I gave
a talk to the Chicago Medical Society, I told them I thought
they might see this disease and I emphasized, look for patients
with severe muscle pain and weakness. We have not seen that as
much as we had in the past. So clearly, I think that it would
be substantiated once we collect all the cases, that the
neurological profile of what we see is changing.
Senator Fitzgerald. When you see paralysis in a patient who
has West Nile, does that mean that the virus is settling in a
Dr. Houff. Well, if you look at the pathology, this virus
is very prone to infect neurons, the neural cells that make the
fibers that supply the muscles and the rest of the nervous
system. It affects those cells more so than the supporting
cells, like astrocytes and denticytes, the supporting cells of
the brain. And so, yes, that is what you are seeing. You are
seeing a cell that has been infected by the virus, a neural
cell, and it is being destroyed by the virus. So that is why
you see the absences.
Senator Fitzgerald. Have antiviral medications been tried
on West Nile at all?
Dr. Houff. Ribavarin has been tried and showed promise in
the test tube, but clinically, from all my knowledge, it has
not been efficacious.
Senator Fitzgerald. Has it been tried in humans?
Dr. Houff. Yes, it has.
Senator Fitzgerald. It has? And it is just not effective?
Dr. Houff. It has been a disappointment, to say the least.
The Israelis feel that, at least in some patients, they got
worse using Ribavarin. But those studies are ongoing, and
clearly, we do not have a treatment as yet.
Senator Fitzgerald. I see that my time is up. Senator
Durbin, thank you.
Senator Durbin. Thank you very much, Senator Fitzgerald. I
might say that your comparison of Louisiana to Illinois was a
much more pleasant idea before last Sunday's Bears game.
Let me ask you this, and forgive me again, this person
whose only academic exposure was biology for poets. If this
question does not make any sense at all, please be kind. But is
there any way of taking a fingerprint or DNA of this virus to
try to trace it back in terms of its origin by country or other
region, or is this--are we dealing with one single type of
virus here that seems to be the culprit?
Dr. Houff. If you look at the genetic profile of this
virus, it is almost identical to the isolate from Israel in
1988 and 1999, that was also present in geese, and I think that
is interesting because geese there, avian species here, and
different from the Romanian circulating virus. So clearly, you
can do that. You can look at the genetic profile. All of the
viruses that have caused human disease have been segregated in
one lineage, lineage one. Lineage two is another genetic group
of these viruses that have not been associated with human
disease. And the isolates circulating in the United States, as
far as I am aware, is, for all practical purposes, identical to
the Israeli isolate in 1988 and 1999.
Senator Durbin. Why do some mosquitoes carry it and others
Dr. Houff. I think that is a critical question. If you--we
do not know the answer to it, Senator. That is the first part
of the question. But when we were talking about urban versus
rural circulation of this virus, it is clear for West Nile and
St. Louis, too, that there is a circulation in rural areas that
is different in a species of mosquito and birds than it is in
urban populations, and that appears to be the case for West
Nile, also, certainly in Europe and probably in the United
States. So I think those are areas that critically need study.
We just do not understand. To show you how little we
understand--Dr. Fauci and I were talking about this--we do not
know the receptors, for instance, where the virus gets into
neural cells. We do not understand that yet. I mean, that is
how basic we are.
Senator Durbin. Let me just ask you to prognosticate, as
Dr. Boozman has. I do not want to put words in your mouth, but
you seem to feel that as far as Arkansas is concerned, you
think next summer may be more challenging, not less. Dr. Fauci,
I think, gave a guarded response saying he thought that--in
fairness to him, I do not want to overstate it, but he thought
that we may see a downturn in infection and death. Dr. Lumpkin,
Dr. Houff, and Mr. Monica, if you would like to offer your
opinion, too, I would appreciate your thoughts on it. What do
you think that we face next year?
Dr. Lumpkin. Again, it is going to be very difficult. New
York, Florida, the following year after the large number of
human cases had a reduction. In Illinois, with St. Louis
encephalitis, we had a dramatic drop-off. We do not really know
what our experience will be next year. I think we have to plan
as if it is going to be as severe as this year and that is what
our response is going to have to be based upon.
Senator Durbin. Dr. Houff.
Dr. Houff. I would agree with Dr. Lumpkin. I think one
thing we have not talked about, as this virus moves West and
South, you are going to have naive populations that have never
seen the virus before, and so I do not know whether you can
compare Illinois to the West Coast, for instance. If you
compare Illinois to New York, clearly, that is what happened.
New York had a hit, then it reduced. Illinois started seeing
birds last year and then we were majorly hit. I suspect that it
may happen, as the virus moves West, we will see the same thing
that has happened to Illinois in other areas of the country.
Senator Durbin. Mr. Monica, do you have an opinion?
Mr. Monica. Thank you. The trend the last 2 years has been
an increase, so we have got to be on guard for that. It is
important that we take all precautions that we can to educate
our people and to put the controls in place to minimize that
mosquito population. We just ask the Federal Government for
support with funding for programs that local taxes, the ones
that do not have a program can get one going and the ones that
do have one, just support us in our effort to fight it.
Senator Durbin. Thank you. My last question to Dr. Houff
is, I am really intrigued by your observation concerning the
Rockefeller Foundation's surveillance labs in other parts of
the world and how that may be good harbingers of perhaps health
challenges and public health trends. In your testimony, you
have suggested that that program has been basically closed down
and I wanted to ask, has any other entity stepped in in terms
of academia or governmental surveillance labs in other parts of
the world to share this information once the Rockefeller effort
Dr. Houff. Senator, I am not aware of anyone stepping in to
that degree. I think World Health has stepped in to some
degree, and I discussed this before I came today with some of
my colleagues with more experience with it. We all clearly
believe that the dismantling of that warning system was
detrimental to us.
Senator Durbin. How long ago did that happen?
Dr. Houff. I believe it happened in the 1980's, the early
Senator Durbin. Thank you very much.
Did you have another question, Senator?
Senator Fitzgerald. Dr. Lumpkin, I want to go back to St.
Louis encephalitis. Encephalitis is an inflammation of the
brain. Does this condition occur after the infectious agent
crosses the blood-brain barrier? Is that correct?
Dr. Lumpkin. That is correct.
Senator Fitzgerald. Is the infectious agent in the case of
St. Louis encephalitis a bacterium or a virus?
Dr. Lumpkin. It was a virus that was essentially a kissing
cousin of the St. Louis encephalitis virus.
Senator Fitzgerald. OK. So this is a very analogous----
Dr. Lumpkin. I am sorry, of the West Nile----
Senator Fitzgerald. It is a flavivirus, correct?
Dr. Lumpkin. Right, kissing cousins.
Senator Fitzgerald. OK. So this is a very similar disease.
Did you say the St. Louis encephalitis started in Illinois in
Dr. Lumpkin. No. In 1975, there was a major national
outbreak, but most of the cases and the deaths occurred in
Illinois. But it was a national outbreak.
Senator Fitzgerald. OK, and did it only last 1 year?
Dr. Lumpkin. No. We have had periodic--because we do
testing, we periodically find positive birds for St. Louis
encephalitis and we have sporadic cases of St. Louis
encephalitis in the State, a few cases a year, then we will
have no cases, and then we will have three or four or five
Senator Fitzgerald. So really, we only had a major problem
in 1 year in Illinois, in 1975?
Dr. Lumpkin. That was the big year, yes.
Senator Fitzgerald. And how many people contracted it?
Dr. Lumpkin. Pretty close to--there were 590-some-odd cases
and 47 deaths.
Senator Fitzgerald. OK. And so as of now, West Nile Virus
Dr. Lumpkin. It is very close. We are 518 cases and I was
just informed we have now had a total of 29 deaths in Illinois.
Senator Fitzgerald. Did we spray heavily for mosquitoes at
that time? I imagine we did. My impression is our mosquito
abatement districts at the local level were much stronger in
those days and had more resources.
Dr. Lumpkin. They were. In fact, some of the news reports
commented on the fact that when they were doing spraying from
trucks in the Chicago neighborhoods this summer, that was the
first time they had done that since 1975.
Senator Fitzgerald. OK. We have not had any discussion of
the health effects of all these sprays, have we? We talked
about that, I guess, while I stepped out.
The maps that have been given to us show that the livestock
are heavily affected already out West, and while they show a
large concentration of human cases in Illinois and the Midwest,
the maps that were given to us do not show a great effect on
our livestock. Would anybody care to comment, Dr. Houff or Dr.
Lumpkin, about what we know about what has happened to cattle
and hog populations?
Dr. Lumpkin. The cattle and the hog population do not seem
to be dramatically affected. The horse population in Illinois
has been. We literally have hundreds of cases. The case
fatality rate in horses exceeds 50 percent.
Senator Fitzgerald. The horses have to be vaccinated for
some forms of encephalitis, do they not?
Dr. Lumpkin. There is a vaccine for West Nile. It is
available. It is a voluntary vaccine.
Senator Fitzgerald. Just for horses?
Dr. Lumpkin. Just for horses. There is a multiple-dose
course that is associated with that and you really have to be
well into the course to be protected from--the horse has to be
well into the course to be protected from West Nile.
Senator Fitzgerald. Now, with respect to our geese
population in Illinois, my understanding is that they have not
been dying from this virus, though many other birds have. But
Dr. Houff, you said that this virus is very similar to a
different virus that previously ravaged geese populations.
Dr. Houff. In Israel.
Senator Fitzgerald. In Israel.
Dr. Houff. Israel, correct.
Senator Fitzgerald. I wonder why it is not affecting the
geese population now. It must be that there is some difference.
Dr. Houff. Whether those are analogous geese or whether
they are genetically different, I do not know the answer. The
virulence factors of the virus are poorly understood, and so we
do not know why species are susceptible or immune or resistant
to it. Clearly, if you look at the animal population in the
United States who has never seen the virus, some of them are
resistant. So either they have a brisk immune response or they
cannot support the virus and its growth, and so we do not know
that. And you can tell that even from animals that are
In the crows, for instance, the virus rarely causes disease
as much in the brain, and you look in the zoo population, the
exotic birds, they get a massive encephalitis. So even in the
bird population, the disease is different and we do not
Dr. Lumpkin. In fact, in Illinois, we have not seen much
amongst the Canadian geese, but the Lincoln Park Zoo had two
red-breasted geese that did die from West Nile. So, again, it
is going to be very closely associated with different species
and sub-species of the avian population.
Senator Fitzgerald. Thank you all very much for your
testimony. Thank you for being here, and good luck in your
continued work on West Nile Virus.
Senator Durbin. Thank you, Senator Fitzgerald.
If there are no further questions, this concludes the
hearing. There may be additional questions submitted for the
record for both panels.
In closing, I want to thank you and tell you how much we
appreciate your sacrifice in coming here today. I think, based
on the hearing that we have had, I am convinced that we need
accelerated research in an effort to develop a test capable of
large-scale screening in the U.S. blood supply for West Nile
Virus and I think the FDA has testified and made it clear that
we need to create some incentive for the private sector to meet
We also need to provide the resources to share the testing
with blood centers across America, so that once it is in place,
that they can use it and can afford to do so. I believe we
should be helping States and localities, as we have this year
with $29 million, and continue that effort so long as we are
threatened by this and other mosquito-borne illnesses.
And finally, I think we need to try to accelerate, if we
can, and it is a big ``if,'' jump start the effort toward a
human vaccine. The thought of waiting 3 years is troubling.
Maybe that is the best that we can do. We certainly do not want
to cut corners when it comes to public health and safety. But
if there is a way for us to focus on this, I hope that we will.
Thank you to all our panelists for providing us insight
today, and with that, the hearing is adjourned.
[Whereupon, at 12:22 p.m., the Committees were adjourned.]
A P P E N D I X
PREPARED STATEMENT OF SENATOR CLINTON
Thank you Mr. Chairman for taking this opportunity to examine this
important issue. As you know, New York was the first state to be
affected by the West Nile Virus in 1999. Since then we have been able
to implement an effective system of disease surveillance, public
education, and transmission control that serves as a model for other
states that are only now having to deal with this new threat. Over the
subsequent years, as a result of those efforts, we were able to reduce
the number of infected persons and the number of deaths even as the
virus spread to larger and larger areas of our state. Our experience
shows that public health measures, when implemented correctly and
adequately, can significantly reduce the harm this new disease can
That said, this year, New York has seen a rise in the number of
infections reported. Furthermore, we are now facing questions over the
safety of our blood supply and life-saving organ transplants. These
worrisome developments remind us of the critical need to support our
current efforts and to redouble our search for even more effective
I am glad that you are all able to join us today and to provide us
with a glimpse into the current and future work being done to protect
our country from this new scourge. As much as we would like to wish it
away, the West Nile Virus is here to stay, and it will take all of us
working together to keep it from continuing on its destructive path.
PREPARED STATEMENT OF JULIE LOUISE GERBERDING, M.D.
Good morning, Mr. Chairmen and Members of the Committees. I am Dr.
Julie Louise Gerberding, Director, Centers for Disease Control and
Prevention. During my tenure as CDC Director, I am committed to
achieving our vision of healthy people in a healthy world through
prevention by a commitment to excellence in science, services, systems,
and strategies. Thank you for your continued support and recognition of
the critical need for a strong, flexible, well resourced public health
system to deal with emerging threats, including bioterrorism and
naturally occurring diseases such as West Nile Virus (WNV). I am
pleased to be here to update you on CDC's public health response to
WNV-related illnesses in the United States. I will also discuss the
status of our WNV prevention programs.
Mosquito-borne illnesses in the United States were largely
eliminated as a health risk in the middle of the last century, although
mosquitoes that can transmit malaria, dengue, and yellow fever remain.
Although Americans have not regarded mosquito-borne diseases as a major
domestic threat for some time, the introduction and rapid spread of WNV
has changed this. CDC has played an important leadership role in
rebuilding the nation's capacity to monitor and diagnose mosquito-borne
viral diseases through state and local public health partners around
the country, but this year's events show that more work remains to be
done. The more we strengthen our nation's front-line workers, whether
in the field or in the laboratory, the better prepared we are to
respond to new and emerging infections, such as WNV.
EMERGING INFECTIOUS DISEASE THREATS
The past decade has seen a significant number of emerging
infectious disease problems in the United States. Some, such as E. coli
O157:H7 and Cyclospora, are foodborne. Others, like hantavirus
pulmonary syndrome, are transmitted from animals to people. Still
others, like Lyme disease and ehrlichiosis, are vector-borne, while
others, like vancomycin-resistant enterococci, result from the
development of antimicrobial resistance in response to the misuse of
antibiotics. Some emerging infectious diseases appear to be caused by
new pathogens; others, in retrospect, have been here all along but were
just not recognized. Some are clearly domestic in origin and others
just as clearly have been introduced from abroad, illustrating the
futility of thinking of infectious diseases in purely domestic or
international terms. Infectious diseases know no borders. We must learn
from the experiences of other countries in dealing with diseases such
as bovine spongiform encephalopathy (BSE), variant Creutzfeldt-Jakob
disease (vCJD), and foot and mouth epidemics in Europe, Ebola
hemorrhagic fever in Africa, and avian influenza in Hong Kong.
CDC launched a major effort in 1994 to rebuild the component of the
U.S. public health infrastructure that protects U.S. citizens against
infectious diseases. In 1998, CDC issued Preventing Emerging Infectious
Diseases: A Strategy for the 21st Century, which describes CDC's plan
for combating today's emerging diseases and preventing those of
tomorrow. It focuses on four goals, each of which has direct relevance
to the detection of and response to WNV: 1) disease surveillance and
outbreak response; 2) applied research to develop diagnostic tests,
drugs, vaccines, and surveillance and prevention tools; 3) public
health infrastructure and training; and 4) disease prevention and
control. The plan emphasizes the need to be prepared for the unexpected
whether it be the next naturally occurring influenza pandemic or the
deliberate release of anthrax organisms by a terrorist. This CDC plan
is available on CDC's website at www.cdc.gov/ncidod/emergplan/
index.htm, and copies have been provided previously to the Committee.
Despite the diversity of emerging infectious diseases, public
health workers, in partnership with health care providers in the United
States, must detect them and respond. This is particularly true at the
state and local levels of the system. CDC and other Department of
Health and Human Services agencies have worked to strengthen the
infectious disease public health infrastructure through cooperative
agreements with states to build epidemiologic and laboratory capacity
and through the development of emerging infections programs which are
now in place in nine locations around the country. In many instances,
these programs have significantly improved our ability to respond to
infectious disease emergencies. Resources for bioterrorism preparedness
and response have also bolstered capacity at the state and local level.
But as highlighted by the Public Health Security and Bioterrorism
Preparedness and Response Act, which originated in the Health,
Education, Labor, and Pensions Committee and as illustrated by the
challenges posed by the emergence of WNV, we still have gaps and needs
to be addressed.
WEST NILE VIRUS
WNV is a mosquito-borne virus first recognized in the West Nile
district of Uganda in 1937. Since then, it has been seen in Europe, the
Middle East, Africa, and as far east as India. The virus lives in a
natural cycle involving birds and mosquitoes, and only incidentally is
transmitted to humans and other mammals, often in outbreak situations.
A closely related virus, St. Louis encephalitis (SLE) virus, acts
similarly in North America. Most humans who become infected with WNV
through the bite of an infected mosquito will develop a mild illness or
will not become sick at all. However, in a small fraction (<1%),
encephalitis (inflammation of the brain) or meningitis (infection of
the membranes surrounding the brain and spinal cord) will develop;
approximately 10% of these patients will die. The elderly are
recognized to be at higher risk than the rest of the population for the
development of severe illness following WNV infection. It is likely
that persons with compromised immune systems are also at higher risk.
The human and animal epidemic of WNV encephalitis which began in
the northeastern United States in the summer and fall of 1999
underscored the ease with which emerging infectious pathogens can be
introduced into new areas. The persistence of virus activity through
2002 indicates that WNV has become established in North America. This
dramatic introduction and spread across the United States of a disease
not previously seen in the Western Hemisphere reinforces the need to
rebuild the public health system to prevent and respond to potential
future introductions of other emerging infections.
WNV was recognized in the United States in late August 1999 when an
alert infectious disease clinician at the Flushing Medical Center in
Queens, New York, reported to the New York City Department of Health an
unusual syndrome of fever and severe muscle weakness in several elderly
patients. Eventually, 62 cases of human illness with WNV were
recognized in the New York City area in 1999.
Laboratory studies of the virus demonstrated it was essentially
identical to a WNV strain which had been isolated from geese in Israel
in 1998, and all viruses identified in New York were indistinguishable
by molecular typing techniques, indicating the outbreak resulted from a
single introduction. When and how that introduction occurred is
uncertain, but based on the wide circulation of the virus in the New
York City area by August 1999, the virus likely was introduced several
months earlier with subsequent unnoticed amplification in nature.
Testing of a limited number of banked specimens from birds and humans
have found no evidence of WNV in New York prior to 1999. Among the
possibilities for how it was introduced are through an infected bird,
through infected mosquitoes, or through an infected human.
In 2000, WNV was detected in 12 northeast and mid-Atlantic states.
A total of 21 persons were found to be infected, 19 with severe illness
and 2 with milder symptoms. Randomly conducted household surveys where
residents were asked to provide blood specimens were conducted in
Richmond County (Staten Island) and Suffolk County, New York, and in
Fairfield County, Connecticut all areas with intense epizootic
activity. Infection rates in the three locations were 0.46%, 0.11%, and
0%, respectively far lower than the 2.6% seen the year before in
northern Queens. In 2001, 359 counties in 27 states and Washington, DC,
reported WNV activity, including 66 human illnesses, to ArboNET, a web-
based, surveillance data network maintained by 54 state and local
public health agencies and CDC. This activity represented a marked
increase from 2000 in both geographic range and number of cases.
CURRENT WEST NILE VIRUS SPREAD
This year, as you know, WNV infection has continued to expand
geographically, reaching epidemic proportion in some states. As of
September 22, 2002, surveillance in humans, birds, mosquitoes, and
horses has detected WNV activity in 42 states and Washington, DC. Among
humans, 1,672 cases with laboratory evidence of recent WNV infection
have been reported from 31 states and Washington, DC. Among the 1,586
patients for whom data are available, the median age was 55 years, with
age ranging from 1 month to 99 years; 855 patients were male; and the
dates of illness onset ranged from June 10 to September 21. A total of
89 human deaths have been reported.
Building on lessons learned from the anthrax attack, we have
activated our emergency operations center to coordinate our response,
deploying field epidemiologists, vector-borne disease experts, and
communications specialists to assist state and local health departments
in the affected states in conducting surveillance, investigating cases,
and implementing prevention and control efforts. As part of this
effort, we have utilized the National Pharmaceutical Stockpile contract
aircraft to rapidly transport specimens to CDC laboratories for
diagnostic testing. In addition, we have provided education to health
care workers, utilized the Health Alert Network (HAN) and the Epidemic
Information Exchange(Epi-X) systems to disseminate information to
clinicians and public health officials, and held press telebriefings
all critical activities both for this disease outbreak and for
strengthening our future response capabilities.
CDC, FDA, and HRSA, in collaboration with blood collection agencies
and state and local health departments, are investigating a series of
cases of WNV infections in recipients of organ transplantation and
blood transfusion. An initial investigation in Georgia and Florida has
demonstrated transmission of WNV in four recipients of solid organs
from a single donor. The source of the organ donor's infection remains
unknown and an investigation of the numerous transfusions of blood
products that the organ donor received is ongoing.
Since the report of these cases, CDC has been informed of other
patients with WNV infection diagnosed after receiving blood products
within a month of illness onset. One of these patients also received an
organ transplant. All of these patients resided in areas with high
levels of WNV activity; investigations are underway to determine
whether transfusion or transplantation was the source of WNV
transmission. In each instance, precautionary measures, including
withdrawal of unused blood products from donors whose blood was given
to these patients, has been initiated.
WNV was isolated from a unit of frozen plasma that had been
withdrawn as a result of one of these investigations. This finding
indicates that the virus can survive in some blood components and
probably can be transmitted by transfusion. In contrast, another
investigation has found that a patient who received a unit of blood
potentially-contaminated with WNV did not develop serologic evidence of
subsequent WNV infection.
To better assess the risk of WNV transmission through blood
transfusion or organ transplantation, CDC is actively engaged with FDA,
HRSA, blood collection agencies, hospitals, and health departments to
identify and follow-up additional possible cases. CDC has requested
public health authorities to determine if persons reported with WNV
infection donated or received blood transfusions or organs preceding
their illness. Prompt reporting of these persons can facilitate
withdrawal of potentially infected blood components. Additionally, the
Public Health Service will work with industry to identify potential
strategies to further increase the safety of the blood supply,
including the development and application of assays that could be used
to screen blood and plasma donations for WNV.
CDC studies have indicated that some patients with WNV infection
have a syndrome similar to that caused by the polio virus. These
patients can have paralysis of their arms or legs, and the paralysis
can affect the muscles that control breathing. This finding is
particularly important since many of these patients were being treated
for Guillain-Barre syndrome--treatment which would have no benefit for
a poliomyelitis-like syndrome and could lead to severe side effects. It
is not known how long the paralysis will last; however, many patients
did not significantly improve several weeks after disease onset. CDC is
planning long-term follow-up studies of these patients.
PUBLIC HEALTH RESPONSE
After the outbreak of WNV in 1999, a West Nile Virus Interagency
Working Group was formed to facilitate information sharing and
coordination of activities among federal agencies with a role in
monitoring and control. CDC leads the working group which includes
representatives from the Departments of Agriculture, Commerce, Defense,
and Interior, the Environmental Protection Agency, and the National
Institutes of Health (NIH) who continue to monitor for WNV activity and
seek ways to prevent future outbreaks, including research by NIH into
the development of an effective vaccine and effective treatment. The
working group routinely assembles for telephone conference calls and
has provided several briefings to keep Congress informed of ongoing
activities. CDC has also conducted weekly conference calls with our
state partners to assure coordination of national surveillance.
As with many emerging infectious disease problems, addressing the
WNV outbreak also requires a strong partnership between public health
and veterinary agencies and the public. Effective systems need to be in
place to ensure: 1) effective monitoring for WNV and other mosquito-
borne diseases and 2) further development of prevention and control
measures, including integrated pest management, public education,
optimal mosquito control measures, vaccines and antiviral therapy.
Further research on the basic biology of the virus and its natural
ecology is also needed.
CDC has been the lead federal agency to respond to the WNV outbreak
in humans. Since fiscal year 2000, DHHS and CDC have provided more than
$58 million to state or local health departments to develop or enhance
epidemiologic and laboratory capacity for WNV and other mosquito-borne
diseases. In fiscal year 2002, approximately $35 million has been
awarded to those public health agencies to address the continued spread
of the virus.
CDC has also provided extramural funding to other federal agencies
for related WNV surveillance and diagnostic activities in support of
the states. A university-based research cooperative agreement was
initiated in fiscal year 2001 to support studies on WNV distribution,
pathogenesis, and variability and to provide training to future
entomologists, biologists, and other vector-borne specialists. And, in
fiscal year 2002, CDC will award funding to three educational
institutions to initiate a program to train scientists in vector-borne
infectious diseases. Finally, CDC has undertaken an aggressive
intramural research program in several scientific areas to address the
long-term needs related to epidemic WNV.
Surveillance, combined with professional and public health
education, is the best strategy to confront the WNV problem. Among the
recommended prevention measures to reduce the risk of exposure to WNV
are 1) eliminating any areas of standing water around the house, i.e.,
draining standing pools, cleaning gutters, and emptying bird baths; 2)
minimizing outdoor activities at dawn, dusk, and in the early evening;
3) wearing long-sleeved shirts and pants when outdoors; and 4) applying
insect repellent according to package directions to exposed skin and
In addition to current activities, the following are some specific
measures that CDC has implemented since the first WNV outbreak three
years ago: developing the tests for use at state laboratories to
diagnose WNV in humans, making and supplying the reagents used for
these tests, and training every state laboratory in how to run them and
how to diagnose infection; implementing Arbo-NET, an electronic
surveillance system to track and monitor WNV and other mosquito-borne
illnesses; convening a national meeting each year to provide public
health workers, laboratorians, and local officials an opportunity to
exchange the latest information about this disease; producing, in
collaboration with partners, consensus guidelines for the surveillance,
prevention, and control of WNV; developing educational materials for
health care providers on the clinical aspects and diagnosis of WNV
infection as well as public education materials; and assisting local
officials with guidance on mosquito control.
In conclusion, addressing the threat of emerging infectious
diseases such as WNV depends on a revitalized public health system and
sustained and coordinated efforts of many individuals and
organizations. As CDC carries out its plans to strengthen the nation's
public health infrastructure, we will collaborate with state and local
health departments, academic centers and other federal agencies, health
care providers and health care networks, international organizations,
and other partners. We have made substantial progress to date in
enhancing the nation's capability to detect and respond to an
infectious disease outbreak; however, the emergence of WNV in the
United States has reminded us yet again that we must not become
complacent. We must continue to strengthen the public health systems
and improve linkages with health care providers and colleagues in
veterinary medicine and public health. Priorities include strengthened
public health laboratory capacity; increased surveillance and outbreak
investigation capacity; education and training for clinical and public
health professionals at the federal, state, and local levels; and
communication of health information and prevention strategies to the
public. A strong and flexible public health infrastructure is the best
defense against any disease outbreak.
Thank you very much for your attention. I will be happy to answer
any questions you may have.
PREPARED STATEMENT OF ANTHONY S. FAUCI, M.D.
Mr. Chairman and Members of the Committee, thank you for the
opportunity to appear before you today to report on the state of West
Nile Virus research at the National Institute of Allergy and Infectious
Diseases (NIAID). Specifically, I will discuss our current research
endeavors to address the diagnosis, prevention, and treatment of this
disease, including our efforts to accelerate the development of a West
Nile Virus vaccine. In addition, I will describe the Institute's future
plans to accelerate and expand research on West Nile Virus within the
context of the overall NIAID research program for emerging and re-
emerging infectious diseases.
WHAT IS WEST NILE VIRUS?
I would like to provide a brief description of West Nile Virus, how
it is transmitted, and its potential effects on the human body. The
virus belongs to a group of disease-causing viruses known as
flaviviruses, which are carried by ticks and mosquitoes. Other
flaviviruses include yellow fever virus, Japanese encephalitis virus,
dengue virus, and Saint Louis encephalitis virus. West Nile Virus
represents an emerging infectious disease in the United States and has
been isolated from more than 40 types of mosquitoes, primarily of the
genus Culex, and from more than 110 species of birds.
West Nile Virus is transmitted to humans by infected mosquitoes,
which generally acquire the virus while taking a blood meal from an
infected bird. Although the entire spectrum of clinical disease in the
United States has not been fully documented, data from outbreaks in the
United States and elsewhere indicate that most infections in humans
(80%) are asymptomatic. About 20% of infected individuals develop
relatively mild symptoms that may include fever, headache, eye pain,
nausea/vomiting and body aches, sometimes with skin rash and swollen
lymph glands. If the virus crosses the blood-brain barrier, however, it
can cause life-threatening encephalitis (inflammation of the brain) or
meningitis (inflammation of the lining of the brain and spinal cord).
The incubation period for West Nile Virus disease ranges from about
three to 14 days.
NIAID WEST NILE VIRUS RESEARCH
Because of the outbreaks and subsequent deaths due to West Nile
Virus infections since the virus was first detected in the United
States in the summer of 1999, NIAID has reacted quickly to strengthen
and enhance its West Nile Virus research portfolio. This effort is part
of NIAID's comprehensive emerging infectious disease program, which
supports research on bacterial, viral, and other types of disease-
Research is underway at NIAID to develop a vaccine, antiviral
medicines, and new diagnostic assays for the West Nile Virus.
Additionally, basic research is providing new clues about the virus
itself, the disease in humans and animals, and how the virus is
maintained in the environment. This knowledge is essential for the
development of strategies to prevent, treat, and eventually control
this disease. While we still have much to learn about the virus, the
examples given below demonstrate the breadth and scope of NIAID's
ongoing West Nile Virus research program and our commitment to
maintaining and ultimately enhancing our role as a major player, in
collaboration with the Centers for Disease Control and Prevention and
the Food and Drug Administration, in combating this virus.
The major areas of NIAID's West Nile Virus research include: Basic
research on the virus itself, on the disease in humans, and on its
maintenance in nature--NIAID supports basic research to better
understand the host, pathogen, and environmental factors that influence
disease emergence. For example, basic research is helping scientists
determine which flavivirus proteins contribute to the virus' ability to
cause disease. Researchers also are investigating how protective immune
responses are elicited within the central nervous system during acute
flavivirus encephalitis. In addition, NIAID supports researchers who
are investigating how West Nile Virus disseminates throughout the
environment. The Institute's International Centers for Infectious
Disease Research (ICIDR) program is supporting research in Mexico to
study whether migrating bird populations carry the virus from its
presumed point of entrance into the Western Hemisphere (New York City)
to points in Central and South America. The emergence of West Nile
Virus in these new areas, which harbor abundant mosquito populations,
could provide conditions for a potentially severe epidemic.
Furthermore, researchers are examining the ecology and persistence
of mosquito-borne encephalitis viruses, including the effect of genetic
variation on the virus' spread and virulence and how birds might be
year-round reservoirs for the viruses that cause encephalomyelitis. In
addition, they are comparing the genetics of St. Louis encephalitis
viruses from throughout California and different parts of the United
States to determine the rate at which the virus is changing, and
whether birds carry it between discrete geographic areas. The Institute
also supports research to better understand the insects and ticks that
transmit flaviviruses. Such an understanding will allow improved
monitoring and surveillance, and enable the development and preliminary
testing of strategies to control vectors of the virus.
Research to prevent and control spread of the disease--Since the
first identified case in humans in the United States, NIAID has
supported research to develop a candidate vaccine against West Nile
Virus. This candidate vaccine is constructed using a licensed yellow
fever vaccine as a backbone for the insertion of genes of the envelope
of West Nile Virus and has undergone preclinical evaluations in
hamsters, mice, monkeys, and horses. The company that developed the
candidate vaccine, Acambis, is moving forward with Phase I trials,
which are expected to begin in early 2003. NIAID intramural scientists
have developed a West Nile Virus vaccine candidate, which they have
tested in monkeys with promising results. This vaccine uses an
experimental dengue virus vaccine as a backbone. Other approaches
include a West Nile Virus DNA vaccine and one that uses expressed
proteins. In addition, last year a hamster model of West Nile Virus was
developed, which closely mimics human disease. The animal model will
help accelerate the development and testing of new vaccines as well as
antiviral therapies in humans.
Research to treat the disease--NIAID supports research to establish
a system to screen chemical compounds for possible antiviral activity
against West Nile Virus. Promising antiviral drug candidates will be
tested in the hamster model. This resource allows scientists to
evaluate a drug's safety and efficacy before moving on to possible
human trials. Other research projects are investigating emerging
diseases and developing candidate drugs to fight West Nile Virus. More
than 300 drugs have been screened, and several have moved forward for
preclinical evaluation. Research on immunotherapeutics (treatments that
modify the body's immune response) also is being explored.
Research to improve detection and rapid diagnosis--Research is
underway to allow for more rapid detection of West Nile Virus in
samples from humans, including organs and tissues intended for
transplantation, in other animals, or in vectoring mosquitoes. This
research occurs mainly at small biotechnology companies attempting to
develop new, commercially available diagnostic assays
Finally, the NIAID maintains the World Reference Center for
Arboviruses at the University of Texas Medical Branch at Galveston. The
Center has reference anti-West Nile Virus sera and seed lots of various
strains of the virus. This international program involves
characterizing viruses transmitted to people and domestic animals by
mosquitoes and other arthropods and researching the epidemiology of
arboviruses of the United States and overseas. During the last 3 years,
these reagents have been provided on request to investigators in the
United States and internationally.
RESEARCH OPPORTUNITIES FOR THE FUTURE
The NIAID has identified a number of opportunities for accelerating
or expanding research to improve the diagnosis, treatment, and
prevention of West Nile Virus. These areas include:
The development of additional animal models, including primate
models, for studies of viral pathogenesis and testing of new vaccines
Studies of correlates of immunity in the hamster model
Immune enhancement of pathogenicity (i.e. effect of prior immunity
to other flaviviruses)
Characterization of severe and milder human disease and delineation
of long-term central nervous system complications, including the effect
of age on disease severity
Molecular evolution of the virus
Comparative virology between disease-causing flaviviruses
Development of diagnostic tools with improved specificity to
eliminate cross-reaction with other flaviviruses
Development of a single diagnostic test that could be used for
Evaluation of components of immune protection
Characterization of mechanisms of cross-protection between
Development and preclinical and clinical testing of candidate
Design and development of new antiviral medicines
Development and evaluation of immune-based therapies
Molecular epidemiology (especially as virus ``evolves'' and
Basic epidemiology/natural history studies of the virus/host/vector
and the establishment of important vector and host components of
flavivirus cycling in North America
Development and testing of new and alternative mosquito control
Definition of viral epizootic/enzootic maintenance mechanisms
Development and assessment of modern methods to predict emergence
and extent of spread of flaviviruses
Establishment/supplementation of overseas research programs in
areas of intense flavivirus activity
New NIAID programs, such as the U.S.-based Collaborations in
Emerging Viral and Prion Diseases and Partnerships for Development of
Novel Therapeutic and Vector-Control Strategies, will increase research
on West Nile Virus. Through partnerships with industry, the discovery
and development of novel antiviral agents against West Nile Virus also
will be expanded. Awards for these programs are expected in the early
fall of 2002. In addition, many of the programs that have been recently
developed and/or expanded to address biodefense in FY 2003, such as the
In Vitro Antiviral Screening Program and the Cooperative Research for
the Development of Vaccines, Adjuvants, Therapeutics,
Immunotherapeutics, and Diagnostics for Biodefense, will support
research on emerging infectious diseases such as West Nile Virus.
Mr. Chairman, despite our ongoing research efforts and early
successes, we still have much learn about West Nile Virus. The NIAID
will continue to expand its research portfolio to address all aspects
of the virus to improve the diagnosis, prevention, and treatment of the
disease. I hope that the information that I have provided here today
has helped in the understanding of the virus and also has demonstrated
NIAID's commitment to address this important public health issue.
PREPARED STATEMENT OF JESSE GOODMAN, M.D.
Mr. Chairman and Members of the Committee, I am Dr. Jesse Goodman,
an Infectious Diseases physician and scientist, and Deputy Director of
the Center for Biologics Evaluation and Research (CBER) at the Food and
Drug Administration (FDA or the Agency). I appreciate the opportunity
to appear today to discuss FDA's response to the emerging threat of
transmission of West Nile Virus (WNV) through blood and tissue. One of
FDA's primary responsibilities is to help ensure the safety of the
nation's blood supply. Within FDA, CBER is responsible for regulating
blood and blood-related products. Our goal is to help ensure the safety
of the nation's blood supply by minimizing the risk of infectious
disease transmission and other hazards, while maintaining an adequate
THE DEPARTMENT OF HEALTH AND HUMAN SERVICE'S (DHHS OR THE DEPARTMENT)
In 1995, DHHS created the Blood Safety Committee to ensure
coordinated activities across the Department. Chaired by the Assistant
Secretary for Health, the Committee includes the Commissioner of FDA,
the Director of the Centers for Disease Control and Prevention (CDC),
and the Director of the National Institutes of Health (NIH). There have
been periodic meetings to discuss important safety and availability
issues concerning the blood supply. On September 13, 2002, the issue of
West Nile Virus was discussed with the Chair of the Blood Safety
Committee. DHHS also established the Advisory Committee on Blood Safety
and Availability (Advisory Committee) to look at broad issues including
global public health, legal, ethical, and economic matters related to
the blood system. On September 5, 2002, the issue of West Nile Virus
was discussed at this Advisory Committee meeting so that the public and
blood industry would be informed of the latest CDC and FDA efforts. In
addition to these activities at the Department, the current status of
the West Nile Virus epidemic was presented as an information item at
FDA's Blood Products Advisory Committee (BPAC) on September 12, 2002.
The BPAC considers scientific technical issues related to regulation of
blood and tissue.
In recent years, tremendous steps have been taken that have greatly
enhanced the safety of our blood supply. While we now face a new
challenge, the American public can be assured that FDA is vigilant in
its efforts to keep blood as safe as possible. In July 1997, CBER
initiated a Blood Action Plan to increase the effectiveness of our
scientific and regulatory actions and to ensure greater coordination
with other parts of the Public Health Service (PHS). We recognized
then, and recognize now, that potential threats to the blood supply
will continue to emerge and we believe that helping to ensure blood
safety requires timely action and a coordinated approach. Consequently,
FDA works closely with CDC and NIH, and seeks input from consumers and
the blood, diagnostic, and biomedical industries, to develop strategies
that lead to appropriate studies, risk assessment, communication, and
any other prevention strategies or regulatory controls needed to
protect the blood supply.
Over a period of years, we progressively strengthened overlapping
safeguards that protect patients from unsuitable blood and blood
products. FDA's blood-safety system includes the following five
measures; all of which are relevant as we address the threat of West
Donor screening: Donors are provided educational materials and
asked specific questions by trained personnel about their health and
medical history. Potential donors whose blood may pose a health hazard
are asked to exclude themselves. Donors also undergo medical screening
to ensure that they are in good health at the time of donation.
Blood testing: After donation, each unit of donated blood undergoes
a series of tests for blood-borne agents such as HIV-1, HIV-2, HBV
(hepatitis B virus), HCV (hepatitis C virus), HTLV-1 and HTLV-II (Human
T-Cell Lymphotropic Viruses), and the agent of syphilis.
Donor lists: Blood establishments must keep current a list of
individuals who have been deferred as blood or plasma donors and check
all potential donors against that list to prevent use of units from
Quarantine: Donated blood must be quarantined until it is
thoroughly tested and the donation records have been verified.
Problems and deficiencies: Blood establishments must investigate
any failures of these safeguards, and correct system deficiencies that
are found by the firms or through FDA inspection. Firms must report to
FDA any manufacturing problems, e.g. biological product deviations that
may affect the safety, purity, or potency of their products.
If any one of these safeguards fails, affected blood products are
considered unsuitable for transfusion and subject to recall.
WEST NILE VIRUS
WNV is the most recent emerging infectious disease threat to public
health and, potentially, to the safety of our blood supply. WNV
primarily infects birds but can be transmitted to humans and other
animals by mosquitoes. The majority of humans who become infected never
develop symptoms. Approximately one in 150 of those people infected
develop serious and life-threatening nervous system infection.
Although FDA was concerned about the possibility of West Nile Virus
being transmitted by blood transfusions, until three weeks ago
available evidence suggested that any risk was likely to be very low.
We knew that such transmission was plausible because the virus is
believed to be present in the blood for a period of a couple of days to
weeks early in infection, including in patients who never develop
symptoms of infection. Thus, a donor could feel well but, after
mosquito exposure, could have the virus present in the blood for a
short time and, while unaware of this, could donate blood. However, the
risk of such an infected donor transmitting infection was believed to
be very low because, unlike classic transfusion-transmitted viruses
such as HIV and hepatitis B and C, where individuals may be infected
for life, in West Nile infection there is no known chronic carrier
state. Persons infected with WNV develop a rapid immune response, which
clears the virus from the blood stream. Thus, to pose a risk to
recipients, a donor would need to donate blood precisely during the
days in which the virus is present in the blood.
In addition, levels of virus in the blood, when present, are low
compared with HIV or hepatitis. Finally, despite three previous years
of reported WNV cases in the United States, and many years of epidemic
infections in other nations, no cases of transfusion transmission had
Risk to the Blood Supply
FDA has been working closely with CDC, state health departments,
and blood organizations as part of the ongoing investigations of the
recent WNV cases where patients had received organ transplants or blood
transfusions. Based on the preliminary results of these investigations,
we believe that it has been shown that organ transplantation can
transmit WNV and that it is very likely that blood transfusion also has
done so. Thus, there is a newly recognized threat to blood safety.
It is important to recognize that the true dimension of the risks
of either blood transfusion or transplantation spreading West Nile
Virus is not defined at this time and more information is critically
needed. The risk could be higher or lower than the case reports
suggest. Our investigations continue and new information, which shapes
our understanding of the risk, comes to light almost daily. We are
working closely with CDC, NIH, the Health Resources and Services
Administration (HRSA), and with colleagues in the blood transfusion
community to address this evolving situation, and to share new
knowledge. We are communicating with Congress, the public, the media,
the blood industry, and health professionals. As we have much to learn,
we strive to present a clear picture of our evolving understanding of
this potential risk.
To better define the risk and to determine what interventions are
needed will require more knowledge. We are investigating case reports
as they are received. We are also working with CDC, the blood
community, and NIH to design and help implement studies that will give
us a better idea of what proportion of donors may be infected in areas
of differing intensity of disease transmission. We are hopeful that
additional studies can provide information as to the degree to which
such infection of donors then translates into risk for blood
recipients. FDA also believes that studies are needed to confirm that
long-lived blood stream infection (viremia) does not occur in persons
who are potential blood donors. In addition, we are encouraging further
studies of the effects on the virus on various conditions of blood
product storage and manufacturing. We also are working with our
partners to study the incidence of infection in frequently transfused
individuals or those receiving plasma derivatives, such as patients
with thallassemia, hemophilia, and immune deficiencies, even though
existing information indicates that steps normally taken in the
manufacturing of plasma derivatives are expected to kill this virus,
thus protecting recipients. All of this knowledge, as it becomes
available, will help us, not only to better understand the nature and
the degree of any risk, but also to shape effective policy and better
protect the public.
While it is true that transfusion has not yet been conclusively
proven to transmit infection to any patients, we now believe, based on
the aggregate of recent reports and laboratory testing, that it is
likely that this has occurred, and can occur in the future. We are
particularly concerned that in 1 of the cases under study, 3 different
donors, among 15 tested, may have carried the WNV at the time of
donation. This would obviously represent a far cry from the predicted
likelihood of something like 1-2 in 10,000.
This estimate is from a CDC modeling study based on the density of
infection during the 1999 epidemic in Queens, New York. Unanswered
questions include: Is the West Nile Virus persisting longer than
expected in the bloodstream of some patients? Is there something
unusual about the donors to this recipient? These possibilities are
under investigation. Regardless of the answers, we now have a very
heightened level of suspicion and concern about all such reports, even
if some may represent coincidental occurrence of transfusion and
infection. Such coincidences can be expected to occur because the same
individuals who need transfusions--the elderly, the chronically ill,
and the immunosuppressed--are also most likely at higher risk to
develop severe West Nile infection.
Based on the growing distribution and increased number of cases of
WNV in this year's epidemic, FDA, working with CDC and NIH, decided it
would be prudent to issue an alert on August 17, 2002, to the blood
banking community about the possibility of transfusion-transmitted WNV,
and to emphasize the need for careful attention to screening procedures
for blood donors, especially the exclusion of donors with even mild
symptoms that could represent early or mild WNV infection. In addition,
where there have been reports suggesting that recipients of blood
transfusions may have been infected by donated blood, we have worked
with the blood banks and state health departments involved to take a
precautionary approach. In these cases, the blood banks, at FDA's
request, have withdrawn any untransfused blood components to protect
other potential recipients while we investigate whether the donor(s)
may actually have been infected.
More recently, we learned that the Mississippi blood donor, who
likely transmitted WNV to a transfusion patient, became ill four days
after donating blood. FDA policies encourage reporting by patients and
resultant evaluation by blood banks of such so-called ``post-donation''
events. We have alerted blood banks to this finding and plan to issue
guidance shortly to emphasize the importance of soliciting and
investigating post-donation reports of illness. In cases of serious
illness, quarantine of blood products and investigation of the donor
illness should provide an additional safeguard to reduce the risk to
possible blood recipients. With regard to donors who never develop
symptoms, we need to continue to investigate and collect information so
that we can develop appropriate policies to further reduce the risk of
Some have raised the question whether not allowing anyone who
reports mosquito bites to donate blood would be appropriate. This would
likely be both inefficient and ineffective. Most people living in areas
where WNV is spread will have had recent mosquito bites and we would
exclude a large number of safe donors for every one donor with actual
WNV infection. In addition, some individuals with WNV infection will
not recall mosquito contact. These factors suggest that such measures
could create serious blood shortages with the potential to hurt far
more people than might be helped.
If areas of intense WNV transmission can be identified, another
measure that could be considered is excluding donors from those areas.
This approach could potentially reduce risk, but the ever-expanding map
of transmission makes it likely that this approach could likewise cause
blood shortages, yet may still fail to exclude a significant number of
infected donors. Nonetheless, if an unexpectedly high risk is
identified in a specific area, such measures could be considered,
particularly if no other effective interventions might be immediately
available. It is also possible that a greater use of autologous blood
collections could be encouraged in areas of intense infection.
The most effective means of reducing the risk of WNV transmission
by blood transfusion, if confirmed to be significant, would be to test
donor blood samples for the presence of the virus. Such testing could
be performed generally (e.g., on all blood donors nationally), which is
most likely, or, if transmission is more restricted, during seasons
where transmission is occurring, or, in donors from selected regions.
If specific populations (e.g., transplant or other immuno suppressed
individuals) were to be identified as being at special risk for severe
disease from receiving WNV infected blood products (and other
populations not), donor screening could be performed to target blood
intended for such individuals. It is unlikely, however, that an
approach focused on specific recipients would be either desirable or
practical, except perhaps as an interim measure were one needed until
testing methods for broader use were made available. All individuals
exposed to WNV are at risk for infection, and the elderly, who appear
most at risk for severe disease, also need transfusions more frequently
than other populations.
What are the prospects for availability of a good blood screening
test for this disease? In short, the prospects are encouraging although
it cannot happen overnight and significant challenges will need to be
addressed. Classic tests for infectious agents involve looking for the
human's immune response to the agent, in the form of antibodies.
However, in the case of this virus, the WNV is present in the blood
during the time period before antibodies develop. Therefore, direct
methods to detect the virus itself will be needed. These methods are
more complex, more expensive, and more difficult to implement on a
broad scale than antibody tests. On the positive side, state and
academic labs, some diagnostic companies, and the CDC, have developed
sensitive tests that can amplify and detect the genetic material of
Tests based on similar technologies, called NAT (for nucleic acid
amplification test), are now universally used in the U.S. to test all
donated blood for the presence of early HIV and hepatitis C infection.
These tests have helped make our blood supply very safe from these
infections, with risks of transmission of these agents in the 1/
1,000,000 range for hepatitis C and in the 1/2,000,000 range for HIV.
The medical diagnostics industry, the blood industry, and FDA have
significant expertise in the development, implementation, and
evaluation of NAT testing. Such experience will be useful in adapting
WNV test methodologies currently in use in diagnostic laboratories to
more widespread and automated use for blood screening. There are many
challenges, including the need to achieve high levels of reliability
when used in populations with very low frequencies of infection, the
lower levels of virus compared to those currently tested, the
difficulties involved in scale-up, and time needed for test development
and wide implementation. For testing organ donors, special challenges
would be added, including timing, logistics, and determination of
whether screening blood samples can rule out infection in tissues and
organs. While we do not yet know if screening of blood will be needed,
we believe it is likely, and therefore most prudent, to move forward to
facilitate its availability as soon as possible.
To this end, we are working with our partners in the blood and
diagnostics industries, including the American Association of Blood
Banks and AdvaMed. Recently, they hosted an important meeting with FDA,
CDC, and state health departments with potential WNV diagnostics
methodologies to discuss the development of assays of potential
utility, to stimulate interest in testing, identify barriers and
approaches to resolve them, and foster technology transfer and sample
sharing, all in an effort to get all partners the information and
materials needed to be as prepared as possible to meet the potential
need for testing. This meeting was quite successful and we plan a
follow-up public workshop at FDA co-sponsored by CDC, NIH, and HRSA in
the near future. Further development and implementation of effective
screening tests for WNV will depend in large part on the efforts and
innovation of our public health and blood and diagnostic industry
partners. It is important to note, however, that FDA can use its
regulatory authority to make such tests available even before licensure
under an investigational new drug (IND) application. Again, while we
hope that this will not turn out to be needed, we must be prepared.
One final approach that could be used in helping to address the WNV
threat, as well as other future and potential infectious risks to the
blood supply, is called ``pathogen inactivation.'' In pathogen
inactivation, a chemical and/or physical treatment of blood products is
used that is capable of killing many infectious agents. FDA recently
held a workshop on this promising and innovative strategy. Several
approaches are currently under study and may be effective at
inactivating viruses such as WNV. Although promising, it is important
to realize that preventive treatment of blood products affects the
products given to all recipients. In other words, if only 1 in 5,000-
blood units had an infectious agent present, for every patient
protected from the disease, 4,999 would receive a product that may be
altered in some ways that could affect its other characteristics and,
perhaps, its safety. For these reasons, these approaches must be, and
are being, carefully evaluated for their immediate and long-term
safety. However, should WNV risk prove significant in degree, or blood
screening be difficult to implement in a timely manner, pathogen
inactivation may prove valuable as an approach to reducing risk in
blood either from high risk areas and/or potentially for blood being
given to recipients at highest risk of developing severe disease. Such
approaches could also be initiated and evaluated in pre-licensure pilot
studies under an IND application. FDA is also currently planning to
specifically address the inactivation of WNV by such methods in
conjunction with its upcoming workshop on WNV donor blood testing.
Treatments for WNV and Vaccine Development
Most people who become infected with WNV will have either no
symptoms or only mild ones. More severe disease occurs in approximately
1/150 of those infected and is manifested as encephalitis, meningitis,
or meningoencephalitis. Encephalitis refers to an inflammation of the
brain; meningitis is an inflammation of the membrane around the brain
and the spinal cord, and meningoencephalitis refers to the combination
of both. There are currently no drugs on the market to treat this
virus. There are currently six IND applications involving two products
in effect at FDA for the treatment of WNV. The National Institute of
Allergy and Infectious Diseases (NIAID) has also supported promising
research to identify and develop potential treatments for this disease.
While there is currently no licensed vaccine available to prevent
WNV infection, FDA is aware of several promising approaches to vaccine
development and believes that this is a potentially viable strategy to
address this increasing public health threat. Because of the increased
presence of WNV in the U.S., NIAID has supported research in this area.
NIAID announced that in 1999 it funded a fast-track project to develop
a candidate WNV vaccine with Acambis PLC. Scientists at CBER are also
engaged in studies, which may hold promise for developing a vaccine
effective against WNV.
Given the important and increasing public health impact of WNV
infection, including the potential threat to blood safety, and the lack
of available vaccines and therapeutic measures, FDA places a high
priority on facilitating the development and review of such products.
As we act on our current knowledge of the risk of WNV to the blood
supply, and share information with the public as it becomes available,
it is also important that we keep the risk, even a risk that is not yet
well understood, in perspective. There has been a remarkable decrease
in the transmission of viral diseases through blood in recent years. We
believe that our experience in dramatically reducing the risk from HIV
and hepatitis will serve us well in addressing whatever needs to be
done with respect to the challenges we now face with the WNV. Thousands
of individuals' lives are saved or transformed every year by organ
transplants. Millions of lives are enhanced by transfusion of blood and
related products. It is essential that we keep these medical procedures
and related products as safe as possible.
We will continue to work closely with our partners in CDC, NIH,
HRSA and the states, and to engage the blood and diagnostics industries
to harness their capabilities to help make a sensitive blood test a
reality. We will continue to share information with and seek input from
the public and from experts outside of government, as we recently did
with both FDA's Blood Products Advisory Committee and the DHHS Advisory
Committee on Blood Safety and Availability. We will continue to engage
the highest levels of attention with the Department, including
discussion of major blood safety policy issues with the Assistant
Secretary's Blood Safety Committee.
As a final note, FDA would like to encourage the public to continue
donating blood because supplies are low and the need is great. Blood
remains in short supply, in part, because of the extensive safety
measures already in place. Some people are concerned that they might
get an infection by donating blood. We want to assure you and the
public that donating blood is a safe procedure. We also want to take
this opportunity to thank blood donors and to emphasize that the
cornerstone of our blood safety system is the volunteer blood donor.
Thank you very much for the opportunity to testify today.
I welcome your ideas and your questions.
PREPARED STATEMENT OF SIDNEY ANDREW HOUFF, M.D.
The outbreak of West Nile Virus (WNV) infections in the United
States has challenged government, medical and veterinary resources. The
rapid geographic expansion and persistence of the virus in newly
established enzootic areas in North America indicate WNV has become
permanently established in the United States (1). Renewed efforts to
understand human disease and the biology of the virus will be necessary
as we are likely to continue to experience outbreaks of WNV for the
I have divided my testimony into two areas. I will first address
the clinical features of WNV infections in humans including our
experience in 2002. I will then turn to the biology of WNV. Here I will
describe additional studies of WNV that will be required to address the
needs of populations at risk of infection, including domestic and wild
The response of the Centers for Disease Control and Prevention and
the Illinois Department of Health have been outstanding. Both federal
and state agencies have provided needed information in a timely manner
to physicians and other health care providers grappling with patients
with WNV. Essential information has been presented on the Internet,
allowing easy access to health care providers. In Illinois, we have
been able to access up to date information on human and animal
infections. CDCP and IDPH sites have offered valuable information for
submission of specimens for testing and other essential information
needed by health care providers. At Loyola University Medical Center
various avenues of communication have been used to provide the latest
information on WNV to attending and resident physicians, nurses, and
allied health personnel. A ``high index of suspicion'' for WNV
infection has been instituted to assure cases of infection are not
overlooked. The Department of Neurology at Loyola University Medical
Center has developed protocols to assure WNV infection is considered in
the differential diagnosis of patients with neurological syndromes
other than meningitis, encephalitis and meningoencephalitis.
Clinically, West Nile Virus infection usually results in an
unapparent infection in humans (1). A serological survey for WNV
antibodies conducted in New York City in 1999 found that approximately
20% of persons infected with WNV had developed West Nile fever. Most
patients who developed symptoms often complain of the sudden onset of
fever, malaise, anorexia or loss of appetite, nausea, vomiting, eye
pain, headache, muscle pain, skin rash and lymphadenopathy (swollen
lymph nodes). The risk of developing serious neurological disease is
based on experience in previous WNV outbreaks in Romania, Israel and
New York City. In the Romanian outbreak of 1996, 1 in 140 to 320
infections led to disease of the nervous system. In New York, 1 in 150
infections resulted in neurological disease. The experience in Israel
is similar to that seen in New York City. These findings suggest that
the WNV strain circulating in the United States and Israel is
associated with a higher rate of neurological infections.
Meningoencephalitis, encephalitis and meningitis have been the
predominant forms of neurological disease associated with WNV infection
(2). Profound muscle weakness and muscle pain have been a prominent
feature in WNV outbreaks in the United States (3).
Our experience suggests that nervous system infection with WNV
during 2002 may have several unusual features. The profound myalgias
encountered in New York City in 1999 and subsequent outbreaks in 2000
and 2001 have not been a prominent feature of our cases in 2002. We
have also encountered involvement of the optic nerve and basal ganglia
more frequently than expected. Whether or not our experience reflects a
true change in the clinical features of WNV meningoencephalitis must
await more extensive study of the clinical features of cases seen in
2002. If the clinical features of WNV meningoencephalitis are indeed
changing, it will be important to recognize these changes as we
confront future outbreaks of WNV infection.
Treatment for West Nile Virus infection has been limited to
supportive measures to control cerebral edema, seizures, and systemic
complications of the infection. Ribavirin in high doses and Interferon-
a are effective in vitro (4). Control studies have not yet been
completed for either agent. One patient has been treated with
intravenous gamma globulin containing high antibody titers to WNV (5).
The efficacy of intravenous gamma globulin cannot be determined from
this one case.
Hyper immune gamma globulin with high antibody titers to WNV could
offer an additional treatment for WNV neurological infections.
Antiviral antibody therapy has been shown to be effective in
experimental and human virus infections of the central nervous system.
Antibody treatment of mice with Sindbis virus infection of the brain
results in clearing of virus from neural cells. Humans with
hypogammaglobulinemia who develop central nervous system enterovirus
infections have been successfully treated with hyper immune gamma
globulin. Gamma globulin therapy can be instituted without the long
delays required for drug development. Individuals infected with West
Nile Virus during the 2002 outbreak are likely to have high titers of
antiviral antibodies in the serum. These patients could serve as donors
for hyper immune gamma globulin that can then be stored for use in
future outbreaks of WNV infection. The genetic stability of WNV suggest
antibodies generated during the 2002 outbreak should be effective in
neutralizing WNV in outbreaks in the near future.
West Nile Virus presents a serious threat to human health for
several reasons. Many, including some members of the news media,
underestimated the magnitude of the problem at the beginning of the
epidemic when only a small number of human cases had appeared. The
current 424 human cases and 22 deaths in Illinois illustrate the
difficulty in predicting the seriousness of these epidemics.
Experience over the last 4 years suggest that we are likely to see
continued outbreaks of WNV infection. The spread of the virus across
the United States will likely be followed by new outbreaks of WNV
infection in humans and animals. Spread of the virus to Canada, Central
and South America by migrating birds will place additional human
populations at risk of disease. The WNV strain circulating in the
United States appears to have a higher rate of neurological infections
than those seen in Romania and other areas of the world. Viral
evolution can result in changes in virulence, disease pattern, host
cell range, and other properties of the virus. While it is true that
viruses transmitted by insects to mammals are constrained in their
ability to mutate, the possibility of changes in the virus are real and
require study. Transmission of WNV by unusual means such as blood and
organ transplantation are of uncertain significance at the present
time. However, since most patients with WNV infection are asymptomatic,
these individuals would not provide a history to blood collection
agencies that would preclude their donation of blood and blood
products. It is important, therefore, to determine the risk of
transmission from patients with asymptomatic infection to better assess
the risk to the blood supply.
Although much is known about arthropod transmitted virus infections
in humans, we also have much to learn. The epidemiology, wildlife
enzootic cycles, and the pathogenesis of animal and human disease of
WNV are important areas requiring further study. The enzootic cycle of
virus circulation is a critical factor in the biology of virus
transmission. A rural or sylvatic cycle of wild birds and ornithophilic
mosquitoes and an urban cycle with domestic birds and mosquitoes
feeding on humans and birds support WNV transmission. Illinois offers
an excellent site to study wildlife factors involved in outbreaks of
arthropod transmitted neurological diseases. The state has experienced
significant outbreaks of both Saint Louis Encephalitis virus and WNV
infection. Elucidation of the factors that support these outbreaks in
Illinois may provide valuable information that will be applicable in
other regions of the country.
The molecular biology of WNV also needs further study (6). The
strain of WNV circulating in the United States originated in Israel. It
has several unique properties. For instance, high avian mortality has
only been encountered in outbreaks of WNV in the United States and
Israel. The rate of neurological disease also appears to be higher in
urban outbreaks of WNV compared to those in rural areas. The viral
properties responsible for these and other features of WNV infection
are only beginning to be understood. Continued efforts are needed to
define viral factors associated with virulence, host cell range, and
the possibility of viral persistence. The evolution of WNV strains in
nature may help us understand how viruses ``jump'' to other species and
present new threats to human health. The immune response to WNV
infection is also an important area of future study that will be
important in attempts to control virus replication in infected
A multidisplinary approach will be needed if we are to understand
the challenges of outbreaks of arthropod transmitted infections such as
WNV. The Conversation Medicine Center of Chicago is a collaborative
effort of Loyola University Medical Center, the Brookfield Zoo, and the
University of Illinois that includes physicians, veterinarians,
entomologists, field biologists and others. The Center is currently
examining areas of research that would benefit from the collaborative
expertise of its members. The enzootic cycle for WNV is one important
area of interest. Isolation of WNV from squirrels and dogs suggest the
virus is spreading to other mammalian species during the 2002 outbreak.
Infection of other mammalian species has been noted in past outbreaks.
In most species WNV infection does not result in titers of WNV
sufficient to serve as a source of infection for mosquitoes or ticks.
However, lemurs in Madagascar and several reptile species have been
shown to develop virus titers in the blood that are sufficient to
infect mosquitoes. Surveys need to be conducted to determine which
species have been infected during the 2002 outbreak and if any support
virus replication to levels sufficient to infect mosquitoes. If such
species are found, the range of mosquito species infected with WNV may
increase. Additional studies of WNV infection in mosquitoes, evolution
of WNV strains in the laboratory and nature, and the factors associated
with spread of infection to incidental hosts are currently being
discussed. We are currently finishing a submission to study the
pathogenesis of WNV infection in the brain in experimental animals. We
believe the multidisplinary approach used by the Conservation Medicine
Center of Chicago and other such groups around the country offer the
best opportunity to successfully address the challenges of WNV and
other vector borne diseases.
The experience gained meeting the challenges of WNV outbreaks will
improve our readiness to successfully address the challenges of
bioterroism. Many of the same technological and epidemiological
approaches used in the investigation of the WNV outbreak will be
helpful in the event we are attacked using similar agents. I would also
suggest consideration should be given to reopening surveillance
laboratories, such as those supported by the Rockefeller Foundation.
These laboratories closed during an era of increased international
travel and increased risk of emerging infections, provided vital
information for the study and control of insect borne viruses.
Reestablishing surveillance laboratories that can warn the emergence of
known viruses or new viruses will be invaluable in the future.
In closing, I wish to thank the committees for the opportunity to
present my views. I look forward to answering any questions you may
have at the hearing on September 24, 2002
PREPARED STATEMENT OF JOHN R. LUMPKIN, M.D.
First of all, let me thank the Committees for this opportunity to
provide testimony on West Nile Virus and it's very real and devastating
effect in Illinois. As one of the States hardest hit, Illinois has been
working hard, using every available resource, to make an impact on
stopping the spread of West Nile. I am hopeful that my testimony can
shed some light on our activities and the needs of our State, and
probably other states that are impacted by this disease.
I know that there are specific questions of interest to committee
members but, I would like to begin with some background on our
experience in Illinois. As you probably know, Illinois, Louisiana,
Ohio, Michigan, and Mississippi have reported the most cases of WNV
In Illinois cases have been reported in 38 of the 102 counties
(approximately \1/3\ of the State). Through 9-20-02 Illinois has
reported 473 cases including 25 deaths (this is a moving target)
Although we have no hard data, numerous survivors have not been
discharged to their homes, but to long-term care facilities or rehab
facilities. We understand a major (at least short term) sequella is
inability to ambulate
The majority of cases have been in the Chicago metropolitan area.
In the Chicago metropolitan area, two areas of suburban Cook County
bordering the City of Chicago (Oak Lawn vicinity and Skokie vicinity)
have been over-represented in the case count.
IDPH has actually planned for WNV since summer 2001. Included in
the Department's FY02 budget was an initiative related to West Nile.
IDPH provided funding to allow a number of local health departments to
develop their own plans to ensure coordination of efforts with
municipalities, mosquito abatement districts, street departments or
other entities that would be involved in such an endeavor.
Infections in Illinois were unlikely prior to 2002. The virus was
first documented to be present in Illinois in September 2001 when there
was evidence in dead crows. Not much time remained in the mosquito
feeding season after discovery of WNV in Illinois in 2001 but the
evidence of it's presence started our preparations in earnest.
Realizing the potential impact, Governor George H. Ryan created a
Cabinet level work group, headed by IDPH, to coordinate the state's
response among the various agencies involved which included the
Department of Agriculture, Natural Resources, Environmental Protection
and Public Health.
The Work Group has been meeting consistently since the early Fall
of 2001, and more recently, talking on a daily basis to coordinate our
efforts and information.
In more general terms, a plan for surveillance of human mosquito
borne infections was established in 1976 and has been implemented
annually since that time.
CURRENT EFFORTS TO CONTROL THE SPREAD OF WEST NILE VIRUS IN ILLINOIS
After WNV was first detected in wild birds in Illinois in May 2002,
IDPH put out press releases concerning personal protection and the
removal of standing water and produced 30,000 color posters and fliers,
over half of which have been distributed to local health departments
and others that request them. Bulletins were issued to all local health
departments and municipalities recommending that at minimum, larvicide
be applied to street catch basins twice during the summer to prevent an
outbreak of WNV.
Prior to the first human case of WNV, Public Health awarded
$264,059 to 20 local health departments to prepare for the expected WNV
outbreak in Illinois. The grants allowed many LHDs to train their
personnel, provide information about WNV to municipalities, and make
contacts with mosquito control agencies.
An additional 18 grants totaling $462,490 have been made to LHDs to
create vector control programs and cleanup mosquito-producing tire
Within a week of learning of the first Illinois resident to
contract WNV on 8/8/2002, the Governor instituted daily meetings of the
four-state agency WNV Task Force, created in 2001, to make funds
available to local agencies to combat the advance of WNV in Illinois.
Within 3 weeks, the first emergency grants were executed.
Since then, emergency WNV mosquito control grants have been offered
to 37 local health departments where human WNV cases have occurred of
which 24 departments have requested and received grants totaling about
$2.6 million providing protection for about 8.1 million people.
Due to the shortage of licensed mosquito control personnel in
Illinois, the Department of Agriculture, in cooperation with Public
Health, issued an emergency rule to allow health department and
municipal officials to apply certain mosquito larvicides, without a
license, after attending a one-hour seminar. Public Health staff have
offered over 20 emergency-rule larviciding seminars to over 500 local
Public Health has provided extensive technical assistance and
advice to local health departments on mosquito control and is working
closely with CDC and DNR and the UI Vet School to determine the
etiology of WNV, especially concerning the two clusters of cases that
have occurred near Chicago, and possible reservoirs and hosts.
Public Health has responded to thousands of phone calls, e-mails
and news media contacts to answer questions from the media and the
What more can federal and state governments do to prepare for next
However, we believe that Increased attention in the form of federal
funds are needed at both the state and federal level for more full-time
Public Health staff to:
Administer a grant program to assist local health departments in
assuring that arbovirus surveillance and control programs are provided
where these services are not offered by mosquito abatement districts or
Work with mosquito abatement districts and other municipal mosquito
control programs to assure the implementation of comprehensive and
effective mosquito control programs next spring that emphasize source
reduction and larviciding.
Provide mosquito control training for local health departments and
municipalities that leads to licensing by the Department of
Agriculture; and training in mosquito and bird collection techniques to
assist Public Health in arbovirus surveillance work.
Provide resources to state public health, animal disease, and
research laboratories to provide the analytical, entomological, and
epidemiological tools needed to fight WNV, as well as funding for
materials and personnel to rapidly perform confirmatory testing
Additional surveillance staff are also needed that can be mobilized
to facilitate rapid processing of human surveillance data, rapid
analysis of data and rapid dissemination of data.
Begin early public information campaigns.
We also believe that USEPA should consider the creation of a
special Pesticide Applicator license for municipal officials. Current
licensing focuses on agricultural pesticide applications. The license
should only require enough training so that municipal officials could
apply low-risk mosquito larvicides.
Have State resources to fight West Nile Virus come at the expense
of other programs?
Local Health Protection Grants, intended to support local health
department programs in water supply, sewage disposal, food sanitation
and infectious diseases were used to support the emergency WNV mosquito
control grants provided by the WNV Task Force to LHDs.
Public Health staff that operate other programs dealing with
general administration, lead, mold and moisture, environmental
toxicology, and structural pest control have been diverted to WNV
Federal money to support bioterrorism preparedness, epidemiology
and laboratory capacity, has made us better prepared to deal with this
outbreak. Specifically, we believe this has been demonstrated with
enhanced rapid communication to LHDs, hospital ICPs, hospital
laboratories and infectious disease physicians and the funding used in
disseminating information about responsibility to report human
infectious disease cases responsibilities and methods of reporting
Where have West Nile Virus infections been most prevalent in 2002,
and why have infections become significantly more common this year, as
compared to years past? Can we expect the number and severity of human
cases to worsen in years to come?
The virus has expanded its range across the Midwest into areas that
include large population centers, such as Chicago, suburban Cook County
and the nearby suburban counties. Although the virus first appeared in
Illinois during August 2001, it was near the end of the mosquito
transmission season. Apparently, in 2001 virus amplification in wild
birds did not reach a level where humans were at significant risk.
In contrast, WNV-positive dead birds appeared in May 2002, at the
beginning of the summer, which permitted summer-long virus
amplification in the wild bird population. Furthermore, the hot summer
of 2002 was conductive to breeding and flight activity of the house
mosquito, the primary vector of WNV. As a result, there was a high
level of virus amplification in birds and mosquitoes. Consequently,
more people were exposed to the virus in 2002.
Is West Nile Virus similar to any other mosquito-borne illnesses
found in the United States? If so, what lessons has the Department
learned from responding to previous outbreaks?
WNV has many similarities to St. Louis encephalitis, which caused
an outbreak in Illinois during 1975. Since then, cases of SLE have been
rare in Illinois, although they have been more common in southern
However, WNV appears to be better adapted to the temperatures in
northern states; it has even been detected in southern Canada.
Because there have been few cases of mosquito-borne disease in
recent years, many local mosquito abatement programs have been reduced
or eliminated, which results in less effective emergency control
programs. Similarly, there are few environmental staff with experience
in mosquito surveillance and abatement at the state level to assist
local officials during emergencies.
State and local mosquito abatement resources need to be rebuilt.
A lesson learned from the SLE outbreak of 1975 was to establish a
system for surveillance of human illnesses before cases occur. In
Illinois we have such a system in place.
Another lesson learned was to establish an ``early warning system''
that became functional in 1976 to detect evidence of arbovirus
infections in wild birds. IDPH also has this type of system in place.
The Department has traditionally collected some 5000 live birds
annually for testing. The bird blood is tested for SLE, EEE and now,
WNV. Additionally, we test mosquito pools as a supplement to live bird
Provide scientifically sound information to organizations that
provide mosquito control services on appropriate mosquito abatement
Our ability to identify and track disease is key to being able to
take appropriate measures. In addition to that very real part of the
equation--both government and individuals can do a lot to curb the
spread of the disease by specific activities. Comprehensive mosquito
abatement programs are important to addressing the problem. But what
remains the single most effective precautions are those that can and
should be taken by individuals:
Stay indoors at times when mosquitoes are most active when
outdoors--wear protective clothing.
Use mosquito repellent containing 25-35% DEET.
Check residential screens to ensure insects are kept out of living
areas and, eliminate stagnant water where mosquitoes might breed.
PREPARED STATEMENT OF NICKIE MONICA
Thank you Mr. Chairman and Members of the Committee. I am Nickie
Monica, Parish President of St. John the Baptist Parish, a residential
suburb of the New Orleans Metropolitan Area. St. John Parish's
population is nearing fifty thousand residents and it is one of the
fastest growing areas of Louisiana. St. John Parish is located on the
Mississippi River which has a substantial industrial job base that has
brought significant economic development and higher than average wages
for its residents.
It is indeed a pleasure to appear before your subcommittee to shed
some light on a growing local problem that has national implications.
Just a short time ago, mosquitoes, like any other insect, were just
another nuisance that interrupted the outdoor life of residents who
live a tropical climate. Unfortunately, it has now been thrust into the
national media because it has become a serious health hazard with
devastating consequences to many families around this country,
including those in my state of Louisiana. Fortunately, Mr. Chairman,
St. John Parish has not yet experienced a human fatality--something I
believe is due to our proactive measures to combat this growing public
menace. However, if a more prominent effort is not put forth, I am
fearful that it is just a matter of time before tragedy strikes home.
St. John the Baptist Parish instituted its own regimented mosquito
program over a decade ago as an added quality of life issue for its
residents. The program is run by professional and licensed
entomologists who are experienced in the field of serveilance and
treatment. Our spraying and treatment program experienced no problems
until the West Nile Virus began approaching Louisiana from the East
Coast states. We immediately allocated 30 percent more funding to the
spraying program without additional surveillance. We also began a
public awareness campaign to encourage residents to minimize the threat
of larvae hatchings around homes and businesses. Additionally, the
Louisiana Department of Health and Hospitals instituted statewide
Public Service Announcements reminding all residents to be vigilant and
lessen the threat of infection. In my opinion, this has been effective
Even though St. John the Baptist Parish has an adequate control
program in place, our financial ability to continue to fight over a
sustained period of time is practically exhausted. We all know this
problem is not going away. The question is how best to ``fight and
fund'' an effective program. The fact that parishes and cities that do
have programs also have West Nile Virus is of a great concern. Mr.
Chairman, I know my own parish and state best and have thoughts on how
to provide a remedy and abate danger. We now have to look to the
experts to tell us what is the best protocol that can be implemented
statewide. It is definitely more than a local problem. It is a national
and state health concern, and the federal government does need to play
a major role in ``fighting and funding.'' Of course, any federal
program must be consistent statewide in order to maximize effective
Mr. Chairman, I also, want to thank the Louisiana Congressional
Delegation and the United States Congress for their efforts to assist
Louisiana and the rest of the affected areas of the country in this
effort. For example, further federal assistance should immediately
begin to provide rapid processing of bird and mosquito specimens
submitted for virus testing, and that would be made possible by the
Mosquito Abatement for Safety and Health Act (S.2935) as introduced by
Senators Breaux and Landrieu. The legislation could allow state and
local governments to react more rapidly by providing funding to
existing programs and states. Too much time has been lost in reporting
results that could further direct control efforts. The point of
surveillance is to detect the virus before it spreads to the human
population; when weeks are required to report results the advantage of
an early warning system is lost. Consequently, immediate preparation
and funding are needed to allow state laboratories to continue testing
dead birds submitted by citizens even after the virus activity has been
detected in a particular parish. The additional data is vital in
determining the exact location of the virus, which, in turn, allows a
more direct assignment of abatement resources.
The Congress should also continue emergency funding for expanded
surveillance, for testing and for state laboratories, which will play a
role in early detection of the virus. My parish needs assurances that
emergency supplemental funds will be available for additional mosquito
control efforts should West Nile or any other mosquito-borne disease
require a response beyond our local capabilities. This becomes
particularly important when the disease is coupled with storms or man-
made catastrophes that stretch available resources beyond their limits.
Mr. Chairman and Members of the Committee, this concludes my
testimony. It was indeed a pleasure to be able to convey my thoughts on
an important issue and a growing national health problem that will
require a unified effort to combat. I want to thank each of you for
your participation and am available to answer any questions you might
have. Thank you.
PREPARED STATEMENT OF FAY W. BOOZMAN, M.D.
West Nile Virus infection is spreading rapidly; and, in Arkansas,
it has reached epidemic levels in horses and birds. This is not unlike
the experience in other states in the nation. In 1999, one state had
evidence of the virus, while 12 states reported it in 2000, with 27
states in 2001 and now we are up to 42 states in 2002. Last year 48
human cases were reported in the U.S.; and, this year as of September
19, 1745 cases have been reported with 84 deaths.
Our neighboring state, Louisiana, had only one human case in 2001.
This year, they have more than 260 human cases. Additionally, with 473
cases in Illinois as of September 20, we are concerned that migrating
birds flying south will increase the disease burden on their way
through Arkansas. It is likely that many of those birds will over
winter in Southern Louisiana where the mosquito population may not die
off due to cold weather.
This leads me to believe there is a real possibility that Arkansas
will have a dramatic increase in human cases in 2003. We currently have
9 confirmed cases, with 18 more pending CDC confirmation.
We want to be ready to have an adequate surveillance and control
program in place. Larviciding to reduce the mosquito population early
in 2003 is a primary control activity that we want to emphasize in
Arkansas. This mosquito abatement would be carried out at the county
level. We are heartened by the financial assistance contained in the
two bills before Congress, which will allow counties to implement these
vital mosquito control programs.
At the state level, our primary needs are to expand laboratory
capacity, and to augment and continue disease surveillance programs
through testing. The coordination and evaluation called for in the two
Congressional bills is necessary to ensure effective use of the
mosquito abatement funding; however, we are concerned that more
resources will be required than the proposed $10,000 in funding
provided for the state.
CURRENT STATUS OF WEST NILE VIRUS ACTIVITY IN ARKANSAS
In Arkansas we currently have 9 CDC confirmed positive cases of
West Nile Virus infection out of 408 blood and cerebrospinal fluid
samples received as of September 19.
Included in the 408 patient samples are 18 suspect cases that have
tested positive by IGM antibody capture ELISA testing at the ADH lab,
but are awaiting a confirmation neutralization test at CDC.
There are currently 54 samples awaiting testing in the ADH
The remainder of the samples from physicians tested negative,
representing 328 patients.
The confirmed and suspect WNV human cases are from Pulaski, Union,
Jefferson, Bradley, Arkansas, Desha, Crittenden, Monroe and Ouachita
The Communicable Disease Nurse Specialists of the Arkansas
Department of Health coordinate with physicians and hospitals testing
for West Nile Virus and evaluate blood serum and cerebrospinal fluid
samples. They determine demographic information on each patient, which
includes age, sex, symptoms, onset date, the date blood was drawn,
patient address, and any travel outside of the state where they may
have been exposed.
Repeat samples are requested if the sample was drawn before
antibodies were formed. It is necessary to evaluate the patients'
symptoms and blood or CSF results before making a diagnosis.
During 2002, as of September 20, the Livestock and Poultry
Commission laboratory has reported 336 positive birds. Decomposed birds
were not tested and 1245 birds were rejected because they were not
suitable for analysis. Positive birds have been found in 48 of the 75
counties in Arkansas. Crows represented 22 percent of the positives,
and 78 percent were blue jays. One owl, one hawk, one dove and one
unidentified bird also tested positive for WNV infection.
During 2002, mosquitoes were trapped at 34 different sites.
Positive mosquitoes were found at five different locations around the
During 2002, as of September 19, there were five positive mosquito
pools found in the counties of Pulaski, Jefferson and Desha. These
positives were of the Culex species and were trapped with both Gravid
and Light traps.
Surveillance in Horses
During 2002, as of September 20, there have been at least 130
horses tested for WNV and 56 have tested positive in 23 counties. The
fatality rate is 39 percent, with 22 horses having died. The Arkansas
Livestock and Poultry Commission conducts equine testing under a
contract with the Department of Health.
During 2002, as of September 19, surveillance of horses for Eastern
Equine Encephalitis has shown 20 cases in seven counties, with 19 of
the 20 cases being fatal, a 95% fatality rate. This is the highest
number of cases of EEE ever recorded in Arkansas and the onset was
earlier in the year than has previously been seen. EEE is more of a
threat to humans than WNV since the death rate in infected humans
ranges from 30 - 70%.
Emergency Funding by the Governor
The Governor has released $1 million from his emergency funds to
the 75 county judges for mosquito abatement. Health Department
personnel developed a formula to equitably determine the amount of
money each county would receive based on evidence of WNV in the county,
its population and square miles.
The funding was distributed through the Arkansas Department of
Emergency Management; however, the ADH facilitated a multi-agency
review process of the applications for assistance. The University of
Arkansas Cooperative Extension Service, and the Arkansas Plant Board
were also involved in the application process.
The Governor also declared Arkansas a disaster area because of the
WNV epidemic. This would make the state eligible for funding from the
Federal Emergency Management Agency (FEMA) for mosquito control. The
Arkansas Congressional delegation has written a letter of support for a
Federal declaration from Health and Human Services Secretary Tommy
County judges, city managers, city mayors and public works
officials are involved in larvacidal treatment of mosquito breeding
areas. They also direct adulticiding if human cases of WNV occur in
their county. Local level Department Environmental Health Specialists
also assisted in setting priorities for mosquito abatement by
identifying mosquito breeding sites. Cooperative Extension Service
Entomologists and county agents also assisted by advising county
officials on mosquito control.
The majority of the 75 counties in Arkansas have little or no
mosquito abatement capabilities. They need money for equipment,
personnel training and chemicals. The estimated cost is $5 million for
the state. The bills pending before Congress now could help address
Centers for Disease Control Support
CDC assisted Arkansas by sending a team of Epidemiological
Intelligence Service Professionals to Arkansas to assist in our disease
surveillance program. They provided technical support in the area of
electronically recording and tabulating data. We now have a database
for human, bird and equine cases. We are also working on a GIS to
pinpoint the location of positive cases.
CDC EIS officers also assisted the Department in identifying
appropriate CDC contacts as questions and issues arose.
Laboratory samples are sent to CDC for confirmation. At CDC these
samples are also tested for EEE, St. Louis Encephalitis and La Cross
CDC has supported Arkansas by awarding a Cooperative Agreement to
the state for $300,000 to cover the period from April 1, 2002 to April
1, 2003. Because of the dramatic spread of the disease during August of
2002 we were awarded supplemental funds of $398,000 for surveillance
and to assist in controlling the disease.
CDC also provided television and radio public service announcements
that could be customized for Arkansas.
The medical community was sent special letters and faxes reminding
them of the necessity to submit blood samples on all patients showing
encephalitis or meningitis, proper preparation of the samples, and
required patient information.
The Environmental Health Specialists were trained in mosquito
abatement by the entomologist at the University of Arkansas Cooperative
Extension Service. They were also trained in surveillance, mosquito
speciation and mosquito trapping by the WNV Project Officer and by CDC
personnel through special mosquito schools.
Local elected officials have been informed as human cases have been
detected in their area. This contact with elected officials has been
primarily by personnel at the local level.
ADH speakers frequently presented at clubs, civic organizations and
other interested groups. The CDC power point presentation augmented
with Arkansas data is routinely presented and is informative and gives
a complete description of the disease and control measures.
We have printed and distributed 23,000 posters and brochures to the
general public. We also printed coloring books for county fairs and
Media relations have been excellent. The Health Director took the
lead in appearing on television and radio. The State Epidemiologist
appeared on talk shows and was interviewed by the television stations.
ADH has conducted three press conferences to release information on
West Nile Virus.
Since August 5, 2002 the Arkansas Department of Health has issued
over 20 press releases. Press releases and educational materials have
been posted on our website and are available for the media and
community to access the latest and most comprehensive information
regarding West Nile in Arkansas. Updates are made as necessary. Media
alerts are sent to statewide media outlets to inform them that the
website has been updated.
The Public Information Office has emphasized the prevention message
and precautions to avoid mosquito bites and to eliminate stagnant water
in their area where mosquitoes can breed.
West Nile Virus Hotline
In order to answer our citizens' questions related to this disease,
a telephone response center was established. The call center operated
on a 24/7 basis with calls being answered by dedicated colleagues and
the Department's Emergency Communication Center.
Because of the large number of phone calls from physicians, para-
medical personnel and the general public it was necessary to have a
Epidemiologist and M.D. on call 24/7. The on-call roster developed for
a Bioterrorism response was effectively used and ensured that a
professional was available.
Through September 11, 2002 the West Nile Hotline has answered 3,417
calls from the general public and health care providers.
Internal Communication Update
Internal Communication was emphasized to ensure that effective and
timely information was provided from the WNV Project Team, to Business
Unit Leaders, and others at the local level, including Hometown Health
Leaders, Health Unit Administrators, Regional Leaders, Group Leaders,
and Team Leaders.
Internal and external communication leaders worked as a team to
ensure timely submission of press releases and communication between
all entities before reports were made public.
Funding is necessary to upgrade and improve our public health
laboratory. The Department's laboratory needs to be upgraded to a Bio
Safety Level 3 so live viruses can be analyzed. Also, our laboratory
needs the capability to test for all types of arboviral encephalitis.
Abatement funding for the counties is estimated to require an
additional $5 million.
The Livestock and Poultry Commission Laboratory test the birds,
mosquitoes and horses on behalf of the Department of Health. Bird
submission by the public exceeded expectations with more birds being
received than the L&PC laboratory has capability to test. To expedite
testing, a real time PCR testing device is needed.
PREPARED STATEMENT OF JOHN BARR
V.I. Technologies, Inc. (Vitex) is pleased today to have the
opportunity to make the Committee aware of a fundamentally new and
important approach to improving the safety of transfusion blood
Vitex applauds the rapid and intense investigation on the part of
the CDC and FDA in dealing with the West Nile epidemic. We also applaud
the creative approaches employed by the FDA with blood collectors and
with companies such as Vitex to search for solutions to prevent the
transmission of West Nile Virus by blood transfusion.
Unfortunately, West Nile Virus also highlights the vulnerability of
the blood supply to an emerging pathogen. Current technology has
limitations. Screening tests can literally take years to develop after
a new pathogen has already entered the blood supply. The test must have
the appropriate sensitivity. The new test is then implemented in all
the community blood centers. Each new screening test can only test for
a single pathogen. Other methods such as donor questionnaires can
inadvertently prevent otherwise healthy donors from donating a unit of
blood and constrain supply of blood components.
For too long our public health system has suffered through the
cycle of blood-borne diseases causing illness and death followed by
months of research to develop a screen that in turn diminishes
potential blood donors. This soon need not be the case. At Vitex, we
are developing a technology, now in phase 3 testing at the FDA, that
will remove or inactivate disease-causing pathogens in red blood cells
and break the cycle of responding to blood-borne diseases one at a time
after they have caused harm or death.
Vitex is a biotechnology company based in Massachusetts that is
pioneering a new technology designed to improve the safety of red blood
cell transfusions. The INACTINE87/64 system for red blood
cells produces a pathogen reduced red blood cell prepared using a
combination of chemical inactivation and red cell purification. The
system is currently in phase 3 testing, the final step in the clinical
development program prior to filing for license approval with the FDA.
The INACTINE87/64 system for red blood cells is a
straightforward three step process. INACTINE87/64 is added
to a unit of red blood cells collected and manufactured just as it is
today. The chemical remains in the unit overnight for the inactivation
to occur. The INACTINE87/64 is then removed using a process
known as cell washing. The resulting unit of INACTINE87/64-
treated red blood cells is then ready for immediate transfusion or can
be stored under standard blood bank conditions.
Pathogen Reduction: Vitex scientists in conjunction with outside
collaborators have demonstrated inactivation of a broad spectrum of
pathogens in full units of red blood cells using the
INACTINE87/64 system. These include both enveloped and non-
The INACTINE87/64 system inactivates gram negative and
gram positive bacteria. Further studies have demonstrated inactivation
of parasites in units of red blood cells that can cause transmission of
diseases such as malaria and Chagas' disease. The system has also has
demonstrated robust removal of prions; an infectious form of the prion
protein is thought to cause the human form of mad cow disease, variant
The INACTINE87/64 system has demonstrated inactivation
of lymphocytes. Based on these studies the system may have the
potential to prevent graft versus host disease and other important
immune complications such as alloimmunization. The system also removes
other proteins that can cause transfusion reactions such as
immunoglobulins, cytokines and other plasma proteins.
West Nile Virus Inactivation: Vitex has completed some experiments
earlier this year with Dr. Fred Brown at the U.S.D.A. facility at Plum
Island. Those studies demonstrated rapid inactivation of West Nile
Virus in a full unit of red blood cells. These data were reported in
August by Dr. Bernadette Alford, Executive Vice President of Vitex at
the FDA workshop on the Safety and Efficacy of Methods for Reducing
Pathogens in Cellular Blood Products.
West Nile Virus and Blood: As of Wednesday, September 18 the CDC
reported 1,641 cases in the U.S. with over 80 deaths from an infection
of West Nile Virus. An extensive investigation has been undertaken by
the CDC and FDA to determine whether West Nile can be transmitted via
organ donation and blood transfusion.
The CDC, in a telebriefing on Thursday, September 19 reported
results of their ongoing investigation. An investigation in Georgia
demonstrates that West Nile Virus transmission can occur via organ
transplantation. A second investigation in Mississippi indicated that
virus can survive in blood components and the CDC concluded that West
Nile Virus ``. . . probably can be transmitted by transfusion.'' (9/19/
02, Update on West Nile Investigation)
Dr. Jesse Goodman, deputy director, FDA's Center for Biologics
Evaluation and Research also participated in the briefing. Dr. Goodman
concurred with the CDC's assessment that blood-borne transmission
likely has occurred in some of these cases.
Dr. Goodman further outlined the actions the FDA is taking to
reduce the potential risk of future blood-borne transmissions of West
Nile Virus. These include product withdrawals of blood products that
may carry a risk of transmission of West Nile Virus. In addition the
FDA is providing guidance to blood collectors on new information to
solicit from donors both before and after the donation. The FDA is also
working with both blood collectors and the diagnostic testing industry
to expedite the development of a blood screening test for West Nile
The FDA is exploring new approaches to improving blood safety.
According to Dr. Goodman:
``Finally, there is another technology, called pathogen
inactivation, which involves treatment of blood and blood products to
kill potential infecting agents. This is a promising tool which FDA
recently held a workshop on, that could potentially be used in our
armamentarium as we address West Nile Virus threat. FDA is and has been
working with manufacturers to evaluate the potential effectiveness and
safety of this strategy, and will continue to discuss this specifically
with respect to West Nile Virus.'' (9/19/02 Update on West Nile
Vitex shares Dr. Goodman's view of the potential of pathogen
inactivation technologies such as the INACTINE87/64 system
to improve the safety of red blood cells. A broad spectrum inactivation
system such as INACTINE(TM) has the potential to improve the safety of
red blood cell transfusions. We further believe the
INACTINE87/64 system may prevent the transmission of West
Nile Virus in a unit of red blood cells. A broad spectrum pathogen
inactivation system also offers the promise of inactivation of future
emerging challenges to the safety of the blood supply.
Implementation of Pathogen Inactivation Technology in the Health
Care System: Over the past several years, Congress has recognized the
inadequacy of the formulas for reimbursing health care providers for
the cost of blood and blood products and for the use of new
technologies. The rapid spread of West Nile Virus shows how essential
it is to introduce new preventive technologies, such as pathogen
inactivation for red blood cells, with a sense of urgency that matches
the speed with which these new emerging threats attack the public's
health. We urge Congress to ensure that adequate reimbursement is made
a priority for new blood safety technologies such as the
INACTINE87/64 system so that the patients can immediately
benefit by their widespread adoption.
VITEX appreciates this opportunity to inform the Congress about the
promise pathogen inactivation presents to improve the safety of the
blood supply and to protect public health.
LETTER FROM SARA C. YERKES, INTERNATIONAL CODE COUNCIL (ICC)
The Honorable Edward M. Kennedy
Committee on Health, Education, Labor and Pensions
SD-644 Dirksen Senate Office Building
Washington, D.C. 20510-6300
Dear Senator Kennedy:
The International Code Council (ICC) commends you and all the
Members of the Senate Committee on Health, Education, Labor and
Pensions and the Subcommittee on Oversight of Government Management,
Restructuring and the District of Columbia on holding a joint hearing
on the West Nile Virus health threat.
ICC is a not-for-profit organization whose mission is to promulgate
a comprehensive and compatible regulatory system for the built
environment through consistent performance-base regulations that are
effective, efficient and meet government, industry and public needs.
ICC develops the International Codes, a single comprehensive and
coordinated functional set of codes governing building construction.
ICC respectfully requests that this statement be included in the
record of the Joint Committee Hearing held on September 24, 2002 by the
two committees mentioned above.
The International Codes can play a key role in the fight against
the West Nile Virus. ICC has over 190 years of collective experience in
developing comprehensive and coordinated codes for building
construction. To date there are 44 states enforcing one or more of the
International Codes. Approximately 97 percent of cities, counties and
states are using documents published by ICC and its members. For more
information on ICC or the International Codes, please visit our
On September 24, 2002 the Committees heard testimony from the
medical and health research communities. The spread of the West Nile
Virus has become a primary concern to health officials across the
country. ICC and its 50,000 individual members, 9,000 cities, 50 states
and over 80 trade and professional organizations can help combat this
Building codes that have been adopted by local governments can play
a key role in the fight against the West Nile Virus and other mosquito-
borne diseases. The best way to prevent the spread of the West Nile
Virus is to attack the breeding ground of the mosquitoes that could
potentially carry the disease. Areas of stagnant water should be
eliminated. In addition, screens over windows and doors should be ``big
tight.'' Most people willingly maintain their properties according to
health standards, but in some cases, certain guidelines must be
enforced. The ICC's International Codes can help. The International
Property Maintenance Code (IPMC) can assist local officials
in enforcing the cleanup of existing properties. The IPMC can
combat the spread of mosquitoes and mosquito-borne viruses.
Local jurisdictions can contribute to the mitigation of this virus
by adopting and enforcing the International Property Maintenance
Code (IPMC). The provisions in Chapter 3 of this code, when
enforced by local jurisdictions, can assist in the slowing down of the
spread of this virus and other infectious diseases by requiring that
property owners meet certain minimum standards in the upkeep of their
property. Requirements such as: (1) the property must be graded and
drained so that there will be no accumulation of stagnant water; (2) a
requirement for the proper drainage of roofs and gutters; (3) a
requirement that addresses the accumulation and disposal of garbage;
and (4) requirements that address the extermination of insects. The
provisions of this code apply to both residential and commercial
Other provisions of the IPMC are also useful to local
jurisdictions. The code also addresses vacant structures and land,
requiring that these properties not ``cause a blighting problem or
adversely affect the public health and safety,.'' It addresses weeds
and excessive plant growth. All of these sections of the IPMC
provide local jurisdictions the enforcement tools they need in order to
require property owners to clean up unsanitary conditions on their
property that harbor the growth and proliferation of the mosquito
Local jurisdictions have a powerful and useful tool in the
IPMC to assist in the fight against the West Nile Virus.
Working in conjunction with local health departments, they can help
ensure the health and safety of their communities. Currently the
IPMC is being enforced in twenty-five states. Three states,
Michigan, New York and Oklahoma, have adopted the code statewide. In
the other states, the code was adopted by local jurisdictions.
In conclusion, ICC offers its assistance to Congress in finding the
best means to protect the public against the threat of the West Nile
Virus. We urge the Members to consider including ICC in the programs to
be operated through the Centers for Disease Control and Prevention
program as called for in S. 2935, ``Mosquito Abatement for Safety and
Thank you for the opportunity to comment on this important national
health problem. Please feel free to contact me if I may be of any
assistance to your Committee.
Sara C. Yerkes
Vice President of Public Policy