[Senate Hearing 107-845]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-845

       RESPONDING TO THE PUBLIC HEALTH THREAT OF WEST NILE VIRUS

=======================================================================

                             JOINT HEARING

                               before the

                  OVERSIGHT OF GOVERNMENT MANAGEMENT,
              RESTRUCTURING, AND THE DISTRICT OF COLUMBIA
                              SUBCOMMITTEE

                                 of the

                              COMMITTEE ON
                          GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE

                                and the

                              COMMITTEE ON
                       HEALTH, EDUCATION, LABOR,
                              AND PENSIONS

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 24, 2002

                               __________

      Printed for the use of the Committee on Governmental Affairs



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                            WASHINGTON : 2003
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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 
                         COLUMBIA SUBCOMMITTEE

                 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

                                 ------                                
Opening statement:
                                                                   Page
    Senator Durbin...............................................     1
    Senator Kennedy..............................................     2
    Senator Gregg................................................     4
    Senator Dodd.................................................     5
    Senator Frist................................................    14
    Senator Landrieu.............................................    14
    Senator Warner...............................................    15
    Senator Hutchinson...........................................    24
Prepared statement:
    Senator Clinton..............................................    53

                               WITNESSES
                      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 
  Health.........................................................    39

                     Alphabetical List of Witnesses

Boozman, Fay W., M.D., M.P.H.:
    Testimony....................................................    39
    Prepared statement...........................................    70
Fauci, Anthony, M.D.:
    Testimony....................................................     9
    Prepared statement...........................................    57
Gerberding, Julie Louise, M.D., M.P.H.:
    Testimony....................................................     7
    Prepared statement...........................................    53
Goodman, Jesse L., M.D., M.P.H.:
    Testimony....................................................    11
    Prepared statement...........................................    60
Houff, Sidney Andrew, M.D., Ph.D.:
    Testimony....................................................    33
    Prepared statement...........................................    64
Lumpkin, John R., M.D.:
    Testimony....................................................    35
    Prepared statement...........................................    67
Monica, Nickie:
    Testimony....................................................    37
    Prepared statement...........................................    69

                                Appendix

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

                                       U.S. Senate,
        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 
            Pensions,
                                                    Washington, DC.
    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 
transfusions.
    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 
may be.
    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 
well.
    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 
issue.
    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 
the witnesses.
    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 
the Chair.
    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 
this.
    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 
concern.
    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 
like this.
    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 
supply.
    Thank you for joining us. It is customary in our 
Subcommittee to swear in all witnesses and I would ask you to 
please stand.
    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 
also internationally.
---------------------------------------------------------------------------
    \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 
transmitting it.
    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 
clarifying point?
    Senator Durbin. Sure. Of course. Senator Gregg.
    Senator Gregg. You said use mosquito repellant that 
included DEET.
    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 
repellant.
    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 
                            SERVICES

    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 
page 57.
---------------------------------------------------------------------------
    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 
for years.
    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 
direct antivirals.
    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 
experiences.
    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 
vaccine development.
    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 
discovery.
    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 
questions.
    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 
                            SERVICES

    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 
exemplary.
    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 
protect others.
    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 
physicians.
    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 
screening.
    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 
Warner.

               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 
health threats.
    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 
Louisiana.
    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 
concerned.
    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 
mosquito.
    So I thank the panel. I am looking forward to hearing from 
you all. Thank you, Mr. Chairman, for calling this hearing 
today.
    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 
opportunity.
    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 
on?
    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 
winter.
    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 
on this?
    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 
years.
    Senator Kennedy. What will that mean for people, that they 
will be able to take it and be immunized to the disease, is 
that right?
    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 
in there.
    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 
needed.
    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 
support you.
    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 
infection.
    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 
accepted?
    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 
years?
    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/
AIDS.
    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 
risk.
    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 
best intervene.
    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 
stay.
    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 
sense advice.
    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 
simple things.
    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 
very short.
    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 
Hutchinson.

            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 
death rate.
    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 
the virus?
    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 
next.
    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 
Frist.
    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 
for me.
    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 
than to----
    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 
East?
    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 
serious disabilities.
    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 
up?
    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 
virus itself----
    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 
virus.
    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 
somebody.
    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 
amplification.
    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 
blood donors.
    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 
panel.
    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 
occurrence.
    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 
correct?
    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 
happens.
    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 
oath.
    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 
their testimony?
    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, 
                            ILLINOIS

    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 
page 64.
---------------------------------------------------------------------------
    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 
in Chicago.
    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 
possible illness.
    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 
response.
    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 
local level.
    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. 
Thank you.
    Senator Durbin. Thanks a lot. Mr. Monica, thank you for 
joining us.

 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 
page 69.
---------------------------------------------------------------------------
    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 
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 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 
efforts.
    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 
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. 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 
with it.
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    \1\ The prepared statement of Dr. Boozman appears in the Appendix 
on page 70.
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    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 
lot.
    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 
questions.
    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 
adulticide?
    Dr. Boozman. Yes, of the mosquitoes, the adult mosquitoes, 
the spraying.
    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 
mosquito population.
    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 
you, sir.
    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 
avian population?
    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 
in Illinois.
    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 
State.
    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 
conclusion?
    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 
this point.
    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 
of treatment?
    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 
issue.
    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 
Fitzgerald.
    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 
illness?
    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 
that out.
    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 
developing.
    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 
nerve?
    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. 
[Laughter.]
    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 
do not?
    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 
dissipated?
    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 
1990's.
    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 
1972?
    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 
cases.
    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 
is close----
    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 
susceptible.
    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 
understand why.
    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 
this challenge.
    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 
cause.
    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 
remedies.
    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 
clothing.
    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.

                              CONCLUSIONS

    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-
causing microbes.
    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:
Basic Research:
    The development of additional animal models, including primate 
models, for studies of viral pathogenesis and testing of new vaccines 
and therapies
    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
Diagnostics:
    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 
multi-species analysis
Prevention:
    Evaluation of components of immune protection
    Characterization of mechanisms of cross-protection between 
flaviviruses
    Development and preclinical and clinical testing of candidate 
vaccines
Therapies:
    Design and development of new antiviral medicines
    Development and evaluation of immune-based therapies
Vector/Host/Ecology:
    Molecular epidemiology (especially as virus ``evolves'' and 
spreads)
    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 
methods
    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

                           FUTURE ACTIVITIES

    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.

                               CONCLUSION

    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 
supply.

 THE DEPARTMENT OF HEALTH AND HUMAN SERVICE'S (DHHS OR THE DEPARTMENT) 
                              COORDINATION

    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.

                               FDA'S ROLE

    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 
Nile Virus.
    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 
deferred donors.
    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

Background
    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 
been reported.

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.

FDA Response
    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 
transfusion-transmitted infection.
    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 
this virus.
    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.

                               CONCLUSION

    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 
foreseeable future.
    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 
animals.
    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 
patients.
    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 
during 2002.
    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 
sites.
    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 
officials.
    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 
general public.
    What more can federal and state governments do to prepare for next 
summer?
    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 
other agencies.
    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 
response.
    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 
states.
    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 
testing.
    Provide scientifically sound information to organizations that 
provide mosquito control services on appropriate mosquito abatement 
practices.
    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 
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 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 
abatement efforts.
    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

Human Cases
    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 
laboratory.
    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 
counties.
    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.

Bird Testing
    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.

Mosquito Testing
    During 2002, mosquitoes were trapped at 34 different sites. 
Positive mosquitoes were found at five different locations around the 
state.
    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 
Thompson.
    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 
this need.

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 
Encephalitis.
    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.

Educational Activities
    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.

Outreach Activities
    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 
schools.
    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.

Additional Needs
    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 
products.
    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

    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-
enveloped viruses.
    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 
Creutzfeldt--Jakob disease.
    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 
Virus.
    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 
Investigation)
    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)
                                                            September 
            26, 2002
The Honorable Edward M. Kennedy
Chairman
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 
website: www.intlcode.org.
    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 
problem.
    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 
structures.
    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 
population.
    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 
Health Act.''
    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.
            Sincerely,
                        Sara C. Yerkes
                        Vice President of Public Policy
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