[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
RESPONDING TO WEST NILE VIRUS: PUBLIC HEALTH IMPLICATIONS AND FEDERAL
RESPONSE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
OCTOBER 3, 2002
__________
Serial No. 107-233
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
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WASHINGTON : 2003
88-611 PDF
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California CAROLYN B. MALONEY, New York
JOHN L. MICA, Florida ELEANOR HOLMES NORTON, Washington,
THOMAS M. DAVIS, Virginia DC
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida DANNY K. DAVIS, Illinois
DOUG OSE, California JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky JIM TURNER, Texas
JO ANN DAVIS, Virginia THOMAS H. ALLEN, Maine
TODD RUSSELL PLATTS, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
DAVE WELDON, Florida WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
C.L. ``BUTCH'' OTTER, Idaho ------ ------
EDWARD L. SCHROCK, Virginia ------
JOHN J. DUNCAN, Jr., Tennessee BERNARD SANDERS, Vermont
JOHN SULLIVAN, Oklahoma (Independent)
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
Subcommittee on Criminal Justice, Drug Policy and Human Resources
MARK E. SOUDER, Indiana, Chairman
BENJAMIN A. GILMAN, New York ELIJAH E. CUMMINGS, Maryland
ILEANA ROS-LEHTINEN, Florida ROD R. BLAGOJEVICH, Illinois
JOHN L. MICA, Florida, BERNARD SANDERS, Vermont
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JIM TURNER, Texas
DOUG OSE, California THOMAS H. ALLEN, Maine
JO ANN DAVIS, Virginia JANICE D. SCHAKOWKY, Illinois
DAVE WELDON, Florida
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Christopher Donesa, Staff Director
Roland Foster, Professional Staff Member
Nicole Garrett, Clerk
Tony Haywood, Minority Counsel
C O N T E N T S
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Page
Hearing held on October 3, 2002.................................. 1
Statement of:
Hughes, Dr. James, Director, National Center for Infectious
Diseases, Centers for Disease Control and Prevention; and
Dr. Jesse L. Goodman, M.D., M.P.H., Deputy Director, Center
for Biologics Evaluation and Research, Food and Drug
Administration............................................. 10
Lumpkin, Dr. John R., M.D., M.P.H., Director, Illinois
Department of Public Health; Deborah McMahan, Commissioner,
Allen County Health Department, Fort Wayne, IN; George
Wichterman, chairman, legislative and regulatory committee,
American Mosquito Control Association; and Mohammad Akhter,
executive director, American Public Health Association..... 58
Letters, statements, etc., submitted for the record by:
Akhter, Mohammad, executive director, American Public Health
Association, prepared statement of......................... 93
Goodman, Dr. Jesse L., M.D., M.P.H., Deputy Director, Center
for Biologics Evaluation and Research, Food and Drug
Administration, prepared statement of...................... 28
Hughes, Dr. James, Director, National Center for Infectious
Diseases, Centers for Disease Control and Prevention,
prepared statement of...................................... 13
Lumpkin, Dr. John R., M.D., M.P.H., Director, Illinois
Department of Public Health, prepared statement of......... 60
McMahan, Deborah, Commissioner, Allen County Health
Department, Fort Wayne, IN, prepared statement of.......... 69
Souder, Hon. Mark E., a Representative in Congress from the
State of Indiana:
Letter dated October 3, 2002............................. 3
Prepared statement of.................................... 6
Wichterman, George, chairman, legislative and regulatory
committee, American Mosquito Control Association, prepared
statement of............................................... 77
RESPONDING TO WEST NILE VIRUS: PUBLIC HEALTH IMPLICATIONS AND FEDERAL
RESPONSE
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THURSDAY, OCTOBER 3, 2002
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:25 p.m., in
room 2167, Rayburn House Office Building, Hon. Mark E. Souder
(chairman of the subcommittee) presiding.
Present: Representatives Souder, Cummings and Schakowsky.
Staff present: Christopher Donesa, staff director and chief
counsel; Roland Foster, professional staff member; Nicole
Garrett, clerk; Tony Haywood, minority counsel; and Earley
Green, minority assistant clerk.
Mr. Souder. The subcommittee will come to order, and I
would like to recognize myself for an opening statement.
Good afternoon, and thank you all for being here today.
Today's hearing will examine the public health implications of
the West Nile virus and the Federal response to the growing
epidemic. We will hear from both Federal agencies and local
officials who are responding in different ways to protect the
public from the West Nile virus.
While West Nile virus has been recognized as a health
threat for over 60 years in other parts of the world, the
disease only appeared in the United States in 1999. For the
past 3 years, the virus has spread quickly across most of the
United States and is now believed to be permanently established
in the western hemisphere. My State of Indiana, and
particularly Allen County, is one of the most heavily impacted
areas in the Nation.
Much is known about West Nile virus, but mysteries and
questions still remain. In fact, only recently was it learned
that the virus could be contracted from organ and possibly
blood donations. Likewise the West Nile virus is also being
blamed for a previously unseen polio-like paralysis in some of
those infected. Just this past week scientists announced that
genetic material from the virus has been detected in breast
milk, raising the possibility that the microbe could be
transmitted through nursing.
The virus is primarily spread by the bite of an infected
mosquito and can infect people, horses, birds and other
animals. And while West Nile virus is believed to make about 20
percent of those infected sick, most of whom experience very
mild flu-like symptoms such as headache and fever which last
only a few days, the virus can cause a severe inflammation of
the brain. Only recently have scientists linked West Nile virus
to a polio-like partial paralysis. And West Nile virus
infection can result in severe and sometimes fatal illnesses.
This year alone the deaths of over 110 Americans have been
attributed to the West Nile virus. Those most at risk for the
severe effects of the disease are the elderly and those with
weakened immune systems, although young are people are
affected, too.
And I personally want to add I have not seen an issue that
has so rattled so many people in an area as it has in my
hometown of Fort Wayne. It has changed band practices, football
games. You get sprayed when you go into a football game. It is
a constant conversation every night at my house at the dinner
table as to whether my son should go out and rollerblade,
whether he should go out at all. I just had one of our major
executives in Fort Wayne say his kids aren't allowed out in the
evenings right now. It has caused disturbances in school board
fights all over my district. There are few things that have
caused as much controversy.
I've had many people ask to include things to be inserted
into the record, and over the next few days I'll be doing that,
but in particular we could not accommodate my friend Indiana
State senator and former county councilman, leader in Allen
County, Tom Wyss to be one of the witnesses today, but he asked
that I include his full statement. I wanted to put a couple of
statements in here, because he's been very outspoken in our
area.
[The information referred to follows:]
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Mr. Souder. There comes a time when public officials need
to depend upon the advice of experts when you have a situation
like the spread of West Nile virus. When the Indiana/Allen
County boards of health agreed that spraying was needed to help
reduce risk of the West Nile virus spreading, it should have
not been delayed by some public officials. We need to work
together, local, State, and Federal, to fight the public enemy
of West Nile virus like we are working together to fight
terrorism.
As I say, this has been a very difficult issue, multiple
deaths, still more notices pouring in on the infection. Part of
the problem has been that there has been no clear test, and
people can't get the results for 3 weeks. Some of them are now
down to 10 days. No specific medication exists to treat it, and
no vaccine is available to prevent it, which means it's as
scary a phenomenon as you can have as a parent and family
member.
Food and Drug Administration has predicted the test may be
available by next summer, and the National Institutes of Health
forecasts a vaccine will not be ready for at least 3 to 5
years. Doctor Jesse L. Goodman of the FDA is here today to
provide us with an update on the progress that is being made in
developing these necessities. Until tests, treatments, and
vaccines are available, prevention remains the only defense we
have against West Nile virus.
Earlier this week the House of Representatives passed a
bill authorizing $100 million in grants for communities to
develop mosquito control programs. Dr. James Hughes, the
Director of the National Center for Infectious Diseases at the
Center for Disease Control and Prevention will tell us today
what actions his agency is taking to protect the public's
health as well as what individuals can do to protect
themselves.
We will also hear testimony from several State and local
officials who are on the front lines of our Nation's effort to
control the West Nile virus. We will hear from my own Allen
County health commissioner, Dr. Deborah McMahan. In Allen
County, by the way, we have one-third of the cases in the
entire State of Indiana.
We're also going to hear from Dr. John Lumpkin, Director of
the Illinois Department of Public Health, which has more cases
than anywhere in the United States; Dr. Mohammad Akhter,
Executive Director of the American Public Health Association;
and Mr. George Wichterman of the Lee County, Florida, mosquito
control district.
It is my hope that from this hearing we in Congress can get
a better understanding of what we can do to assist the efforts
of the Federal and local health authorities in controlling West
Nile virus. Likewise, I hope that the representatives of the
Federal agency will listen to the testimony of our other
witnesses so they can gain a greater appreciation of those
needs and the viewpoints of those in the front lines in our
efforts to control West Nile virus.
We had originally hoped that the administration panel could
go second to respond to those issues by State and local, but
they have requested they testify first, and that is the long-
standing protocol of our committee, and we can do followup
questions if we need.
I thank you again for--all of you for being here, and I
look forward to hearing your testimony and insights. And I'd
now like to yield to the distinguished ranking member, Mr.
Cummings, of Maryland.
[The prepared statement of Hon. Mark E. Souder follows:]
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Mr. Cummings. Thank you very much, Mr. Chairman. Let me,
first of all, thank all of our witnesses for appearing before
us today to discuss their efforts, the challenges they face and
the lessons they are learning as front-line combatants against
the West Nile virus epidemic.
West Nile virus is new to the United States, but it is not
a new disease. First diagnosed in Uganda in 1937, West Nile
virus has since spread to other areas in Africa, the Middle
East and parts of Europe. Three years ago it arrived in the
United States, and it's rapid spread from New York City where
the initial outbreak occurred to other parts of the country
confirms that the virus is now firmly established in the
Western Hemisphere.
Today's hearing, Mr. Chairman, is especially timely. Just
this morning the tragic impact of the West Nile virus hit home
for my constituents as Maryland public health officials
reported that a kidney transplant patient at Johns Hopkins
Medical Center, which is located in my district, died after
testing positive for the West Nile virus. Although there had
been six previously reported cases of West Nile virus infection
in Maryland, none had resulted in the life-threatening illness,
and this is the State's first West Nile fatality.
As is the case in a number of the 116 West Nile deaths that
have occurred across the country, the source of the infection
in the Maryland death is unclear for the time being. According
to the Maryland Department of Health and Mental Hygiene,
initial tests for the virus on the organ donor were negative.
And the department, the American Red Cross and the Centers for
Disease Control and Prevention are investigating the
possibility of transmission through blood transfusions or from
outside exposure.
The West Nile virus epidemic is frightening to Americans
because we have limited testing capability, no vaccine, as the
chairman said, and no specific therapies for treating the West
Nile encephalitis and meningitis that develop in a small
percentage of persons infected with the virus. It is the rare
individual who does not receive a mosquito bite during the
course of a summer season.
The rapid spread of the virus suggests that within a short
period of time, virtually all Americans could be at risk of
West Nile virus infection if they are not already. There's
still much we do not know. Indeed the possibilities of
contracting the virus from organ transplantation and blood
transfusions was confirmed only within the last month or so.
Fifteen people this year have been diagnosed with the West Nile
virus within a month after receiving blood transfusions.
Another recent case raised questions about the safety of
nursing by mothers who may be infected with the virus. Just
over 2 hours ago the Centers for Disease Control and Prevention
confirmed that the infant in that case did, in fact, get the
virus from breast milk. The suspected source of the mother's
infection is a blood transfusion, and blood from the same donor
is also believed to be the source of another West Nile
infection.
Numerous investigations into individual cases as well as
efforts to map the spread of the virus nationwide are ongoing.
To date, 42 States have reported cases of West Nile infection
in humans, mosquitoes, birds or other animals. Thirty-two
States have reported cases of human infection. Inexplicably,
for the first--for the time being Illinois has been the hardest
hit with 32 human deaths having occurred this year alone and
massive impact on bird populations. As you know, Mr. Chairman,
three members of this panel are from Illinois, so I'm glad that
Dr. John Lumpkin, the Director of the Illinois Public Health
Department, is able to appear today at the minority's request.
We can only hope that the terrible experience Illinois is
having will yield knowledge that will be instructive to other
States across the country.
By all accounts, the Centers for Disease Control and
Prevention, the Food and Drug Administration and other Federal
agencies that make up our Federal public health infrastructure
ought to be commended for their efforts to respond to this
epidemic. Even as we recognize the aggressive efforts of our
public health agencies to respond to this new threat, it is the
duty of this oversight subcommittee to ascertain what gaps may
exist in our public health system and what more might be done
by our government to ensure the health and safety of the
American public from West Nile virus and similar future
threats. This hearing is a constructive step in that process.
And I commend you, Mr. Chairman for calling this hearing and
giving us the opportunity to hear from all of our invited
witnesses. I yield back.
Mr. Souder. Thank you.
Before proceeding I would like to take care of a couple of
procedural matters. First I'd ask unanimous consent that all
Members have 5 legislative days to submit written statements
and questions for the hearing record. And any questions, and
any answers to written questions provided will also be included
in the record. Without objection, it is so ordered.
Second, I ask unanimous consent that all exhibits,
documents and other materials referred to by Members and the
witnesses may be included in the hearing record, and that all
Members be permitted to revise and extend their remarks.
Without objection, it is so ordered.
Would the witnesses on the first panel please rise. Raise
your right hands. I'll administer the oath. As an oversight
committee it is our long-standing tradition to swear in all
witnesses.
[Witnesses sworn]
Mr. Souder. Let the record show that the witnesses have
each answered in the affirmative.
I think we're going to go ahead with the testimony on the
first panel. I know Congresswoman Schakowsky from Illinois
wants to give a statement, and we'll get at least your
statements in the record. I just ran into her in the hall a few
minutes ago. She's trying to cover two things simultaneously,
so she'll be over. But we'll start with Dr. Hughes.
STATEMENTS OF DR. JAMES HUGHES, DIRECTOR, NATIONAL CENTER FOR
INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND
PREVENTION; AND DR. JESSE L. GOODMAN, M.D., M.P.H., DEPUTY
DIRECTOR, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, FOOD
AND DRUG ADMINISTRATION
Dr. Hughes. Thank you very much, Mr. Chairman, Mr.
Cummings. It is a pleasure to be here with my good friend and
colleague Dr. Goodman from FDA. Thank you for your invitation
to testify on West Nile virus-related illnesses and CDC's
public health response.
Although Americans have not regarded mosquito-borne
diseases as a major health risk for some time, the introduction
and rapid spread of West Nile virus in the country has changed
this. In 1998, CDC issued Preventing Emerging Infectious
Diseases: A Strategy for the 21st Century, which described
CDC's plan for combatting today's emerging diseases and
preventing those of tomorrow. The plan emphasizes the need to
be prepared for the unexpected. The West Nile virus is a
dramatic example of an unexpected emerging infection.
West Nile virus was first recognized in the West Nile
district of Uganda in 1937, as we've heard. Since then it has
been seen in Europe, the Middle East, Africa and as far east as
India. The West Nile virus was first recognized in Northeastern
United States in 1999, and as you can see on the map, it has
subsequently spread across much of the country. The virus has
been found in 42 States and Washington, DC.
This year, through yesterday, there have been 2,530
reported human cases of West Nile virus infection; 125 of these
patients have died tragically. While most people who become
infected with West Nile virus develop a mild illness or do not
become sick at all, a small fraction, less than 1 percent,
develop neurological disease. Approximately 10 percent of these
severely ill patients die. Some patients with West Nile virus
infection experience a polio-like paralysis. It is not known
how long the paralysis will last, and we are planning long-term
followup of these patients.
CDC, FDA, HRSA and State and local partners are
investigating some cases of West Nile virus infection with
onset of illness following blood transfusion and organ
transplantation. To better assess these risks, we are actively
engaged in identifying and following up on additional possible
cases. Dr. Goodman will address the transfusion issue in more
detail in his statement.
In addition, breast milk from a woman with West Nile
encephalitis has been found to contain West Nile virus RNA. The
infant, who remains well, has IGM antibody to West Nile virus.
CDC is the lead Federal agency for response to the West
Nile virus outbreak in humans. Building on lessons learned from
last fall's anthrax attacks, we have activated our emergency
operation 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.
With the U.S. Geological Survey, the Department of
Agriculture and other partners, we are monitoring the spread of
West Nile virus in humans, birds, and animals. Maps such as
these aid in developing and implementing prevention and control
strategies regionally and locally. You can see perhaps in that
graphic the reported human cases on top, this year the
geographic distribution in the middle, the avian cases, and on
the bottom the veterinary cases, which are predominantly in
horses.
We have provided education to health care workers,
disseminated information to clinicians and public health
officials, and held frequent press telebriefings, all critical
activities both for this disease outbreak and for strengthening
our future capabilities.
Since fiscal year 2000, the Department of Health and Human
Services and CDC have provided more than $58 million to State
and local health departments to develop or enhance
epidemiologic and laboratory capacity for control of West Nile
virus and other mosquito-borne diseases.
In conclusion, addressing the threat of emerging infectious
diseases such as West Nile virus depends on a revitalized
public health system and sustained and coordinated efforts by
many agencies and organizations. We have made substantial
progress to date in enhancing the Nation's capability to detect
and respond to this infectious disease outbreak. However, the
emergence of West Nile virus in the United States has reminded
us yet again that we must not become complacent. As our new
Director Dr. Julie Gerberding says, ``complacency is the enemy
of preparedness.''
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 system is
the best defense against any disease outbreak.
Thank you again for the opportunity to testify. I will be
happy to answer any questions you may have.
Mr. Souder. Thank you.
[The prepared statement of Dr. Hughes follows:]
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Mr. Souder. Dr. Goodman.
Dr. Goodman. Good afternoon, Mr. Chairman, Mr. Cummings.
I'm Dr. Jesse Goodman. I'm an infectious disease physician and
scientist and Deputy Director of the Center for Biologics
Evaluation and Research at FDA. I would like to thank you for
providing FDA with the opportunity to talk with you about West
Nile virus today.
There are and always will be newly emerging infectious
diseases which pose a threat to human health. Unfortunately,
some of these will likely also threaten the safety of the blood
supply, and West Nile virus is the newest such challenge.
In this testimony I'd like to try to do three things. First
I'll provide a chronology of recent events from the perspective
of the safety of the blood supply; second I'll tell you about
what our response has been to date; and finally, I'll tell you
about plans to further address the problem. I think you'll see
we've come a very long way in just 4 short weeks.
I'd also like to take this opportunity to mention what I
feel has been extraordinary cooperation between CDC and FDA and
an impressive pace with which the case investigations of
concern here have been and are being conducted. I also want to
thank the involved States and the blood organizations whose
response has been exemplary under very difficult and
challenging circumstances.
Until 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 this year, on
August 17, FDA, in consultation with CDC and NIH, issued an
alert. This alert to 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 infection. And
I should say we did this with no--in a setting of no previous
reported cases of transmission of West Nile in this manner.
Then about 4 weeks ago, as you know, the initial results of
the investigation of a cluster of cases of West Nile among
organ transplant recipients from a single donor led to the
strong suspicion that the virus could be transmitted by organ
transplantation, and we now believe it's almost certain that
the organs from a single donor carried the infection to four
recipients. The source of that donor's infection, as you have
heard mentioned, may have been from a mosquito or from
transfusions.
During our current state of heightened alert, additional
cases in which West Nile virus disease developed in the days to
weeks following transfusion both in and out of the setting of
transplantation have been reported to date and are under
investigation; for example, the case--the unfortunate case
mentioned by Mr. Cummings. In each case studied so far, the
patients were from areas of known mosquito transmission.
However, special studies of blood donated to a single patient
in Mississippi who later developed West Nile disease suggested
that three blood donors may have unknowingly and coincidentally
had the West Nile virus in their blood at the time of their
donations. So far one of these donor's infections has been
confirmed, including detection of live virus in frozen plasma
from the same patient.
In addition, just last week, we learned that two different
individuals who developed West Nile virus infection had both
previously received transfusions; in one case platelets, and in
the other red cells from a single donor whose retained blood
samples from that donation have tested positive for West Nile
virus.
Based on these ongoing investigations and particularly the
cases I mentioned, we have identified a risk to blood safety.
We do not yet know how big or small that risk might be.
Critical studies are being implemented in different donor
populations to better assess the risk to blood and organ
recipients. Meanwhile, we have taken several important steps.
First, we're continuing to encourage reporting of cases of
West Nile that follow recent transfusion or transplantation,
and if a case is reported in a recent donor, any blood products
which might still be available are being withdrawn to protect
others, even before any infection in the donor has been
documented.
Second, FDA is working with blood banks and will soon
provide guidance to improve the reporting of postdonation
illnesses and the appropriate actions to be taken. I should
mention in one of these cases an individual who had been well
at the time of donation shortly thereafterwards developed
symptoms of infection. And these steps again include withdrawal
of products where needed to help protect others.
Third, because of the potential--and this is what we're
quite concerned about--for West Nile virus transmission from
donors who never develop any symptoms of infection, FDA
believes it is important to be ready and able to move rapidly
toward testing donor blood. No validated test is currently
available for screening of donor blood, and such screening of
large numbers of samples cannot be implemented overnight.
To jump start that process of getting a reliable and
practical blood screening test, we recently took the step of
proactively meeting with the American Association of Blood
Banks, AdvaMed, which is a medical device manufacturer
association, and other partners in the blood banking and
diagnostic testing laboratories, along with Federal and State
laboratories whose tests could be readily adapted to this need.
We have signaled our view of the high importance of making
testing available and our willingness to provide maximum
flexibility in moving this forward. CBER will also continue
and, where necessary, seek to expand its related work relevant
to the development and review of potential West Nile virus
diagnostic tests, vaccines and treatments.
I'm pleased to be able to continue to report that the
medical diagnostic and blood banking communities are highly
engaged and motivated by the public health importance of this
problem. While the success of these efforts depends largely on
their overcoming some scientific and technical obstacles that
may be significant, our hope and intent is that a West Nile
virus screening test for blood could be made widely available
at least for study use under an investigational new drawing
exemption for the next transmission season and perhaps sooner,
if possible in more limited settings.
In addition, based on our evolving knowledge, my
expectation is that if the epidemic continues, FDA will
recommend the use of blood donor screening tests for the
presence of West Nile virus once approved. At the same time,
we're 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 to determine whether
they will work for West Nile virus.
In conclusion, we do believe there is sufficient evidence
to say that there is a risk to the blood supply from West Nile
virus, and we are taking this risk extremely seriously, and we
are acting upon it. At the same time, we want to communicate
this risk in perspective. There are approximately 4\1/2\
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 from West Nile virus is likely to be low
overall, our knowledge is very recent and is limited and
changing rapidly, and, in fact, as Jim mentioned, through
frequent telebriefings, public meetings, etc., we are trying to
continuously communicate new knowledge as it becomes available,
including to you Members of Congress.
Patients should be aware that this risk exists and can
discuss their concerns and their medical treatment and possible
options with their physicians. FDA, CDA, HRSA, all our partners
are continuously monitoring this situation. We can expect
continued reports of West Nile virus both naturally occurring
and potentially transfusion-related to occur even as the peak
period of West Nile virus transmission passes for this year. We
will continue to work together to better understand and deal
with this risk as quickly and effectively as possible.
Meanwhile, I'd also like to take the opportunity to remind
everyone that voluntary blood donation is a key to maintaining
an adequate blood supply, and regardless of the findings here,
blood donation remains safe. Blood has been in short supply
very recently, and we encourage and we thank all of America's
blood donors for making a commitment to donate blood
periodically. We've come a long way in a few short weeks. I'm
optimistic that we can and will respond to this new challenge
quickly and effectively. Ultimately, though, success and
controlling the mosquito-borne epidemic itself will be critical
in determining the risk of infection to the blood supply and
the need for routine blood donor screening.
Again, I thank you very much for the opportunity to be here
today and would be very happy to answer your questions.
[The prepared statement of Dr. Goodman follows:]
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Mr. Souder. I want to thank you both for your testimony.
Before we move to questions, Congresswoman Schakowsky is
recognized for an opening statement.
Ms. Schakowsky. I want to thank you, Mr. Chairman and
Congressman Cummings, for convening today's hearing to explore
the public health implications of West Nile virus and the
Federal response. This is a particularly important hearing for
my State of Illinois and for my district. Although the
statistics are changing daily, the most recent numbers that
Illinois--show is that Illinois has suffered the highest
numbers of human cases of West Nile virus in the country: 614
cases. Is that right, Dr. Lumpkin? Something like that. Thirty-
five people have died as a result, including 15 in suburban
Cook County. In my own district there have been 42 confirmed
cases of West Nile virus in the village of Skokie, almost 50 in
Evanston, and 10 in Morton Grove and Lincolnwood. The mayor of
Morton Grove is now recovering from a bout with West Nile.
These numbers reflect the uncommonly high outbreak ratio in
the Chicago metropolitan area, which accounts for 86 percent of
all cases throughout the State. I'm pleased to say that the
contact the municipalities in my district have had with Federal
authorities, specifically the CDC, have been quite useful in
providing critical expertise and assistance.
On behalf of my constituents and their local elected
officials, I want to thank our CDC witness for the work the
centers have done; however, I am concerned that Illinois, one
of the most affected States in the Nation, has not received its
fair share of Federal resources in combatting this epidemic.
While Illinois received $300,000 at the beginning of the year
and additional emergency funding in August and on September 30,
the funding received by Illinois and the city of Chicago lags
far behind those of other States. In fact, the totals for
Illinois and the city of Chicago come out to $1.6 million for
the fiscal year out of a total of roughly $35 million handed
out to State and local health departments. That is 4.5 percent.
I commend Senator Durbin in his fight to bring more funding
to our State, funding that is needed to allow us to win the
battle against this horrible virus. I'm not arguing that other
States should not receive the funds that they need to respond
to West Nile. I'm not arguing that the Federal officials have
not been as responsive as they can. I'm arguing that we need to
provide all the funding necessary so that Illinois can receive
the resources necessary to protect against the West Nile
outbreak and other public health threats. We must invest
necessary resources in providing States, and in turn localities
and individuals, with information, funds and training.
As a Chicagoan I never thought I would find myself praying
for an early and a cold winter, but I am. Winter will give us
some relief, but it should not lull us into inaction. We need
to use the coming months to aggressively plan for when the warm
weather and mosquito season return next spring and summer. We
must be not only prepared to respond for the next season of
West Nile, but need to take preventative measures to try and
avert an even worse outbreak next year. Part of that means
adequate funding for States and local abatement authorities.
As Dr. Lumpkin, our Illinois health department director,
will suggest, we may need to expedite training and
certification protocols so that more hands will be available to
participate in the prevention process and so that other key
personnel will not be diverted from ongoing public health care
needs. We need to do much more to educate the public. We need
to do more multilingual outreach. We need to do more to alert
the elderly to this problem who are particularly vulnerable and
the steps that they can take to protect themselves. We need to
reach special populations through a multimedia campaign and by
direct outreach. We need a major new investment in our public
health care system to prepare not just for the future West Nile
outbreaks, but all possible health threats, the expected as
well as the unexpected. I'm particularly interested in the
recommendations of Dr. Akhter of the American Public Health
Association in this regard.
I want to welcome our witnesses. I want to extend a special
welcome to our public health director from Illinois, Dr. John
Lumpkin. I appreciate each of you taking time to be with us,
and I look forward to your testimony and to working closely
with you on protecting and improving our Nation's public
health.
Thank you, Mr. Chairman.
Mr. Souder. Thank you.
One of the things that's apparent is that we have a
particularly huge shift into the midwest, with Illinois, with
600 cases Michigan I believe is second. I represent the
northeast corner of Indiana. If you extrapolated our one county
to the State of Illinois, you'd have 1,250 cases in Illinois.
That suggests that we have a corridor, if they're concentrated
in Chicago, rather than downstate and southern Michigan and
northern Indiana.
Something has happened, and I wanted to kind of--we were
looking at the April 2001 CDC Set of Revised Guidelines for
Surveillance, Prevention, and Control of West Nile, and it
recommended enhanced surveillance for many States, including
active bird and mosquito surveillance as well as enhanced
surveillance of animals and humans. And the guidelines note an
appropriate timely response to surveillance is the key to
preventing human and animal disease associated with West Nile
and other arboviruses. The guidelines recommended this type of
approach for the northeast in spring and fall, and also active
ecological surveillance and enhanced pest surveillance in the
southern United States; but it is not recommended for the
midwest and Western States, only that there would be efforts to
increase awareness in the medical community, dead bird
surveillance and enhanced passive human surveillance during the
spring.
That last graphic was described elsewhere in the report as
a backup system that I'm interested in the process of.
Obviously you have difficult tradeoffs. Obviously there are
funding questions. How do you--how did you determine that the
midwest in particular, which has been hard hit in this season,
would not have a more active? When did you start to do more
active in the midwest? You alluded to now going in and
providing local assistance, and could you explain the process a
little bit so we can understand that here in Congress?
Dr. Hughes. Yes. Thank you, Mr. Chairman.
Let me try to respond to that. As all of us have
acknowledged this is an emerging infectious disease. An
excellent example, the disease first appeared in New York City
in 1999 and, as the other map showed, has moved to the South
initially over the last couple of years, and to the West, and
then this year back up into the midwest. The cases occurred
earlier this year than in previous years, and they occurred
initially in Louisiana, Mississippi and Texas. That outbreak
has appeared now to have waned. As the summer went on, as we
all know, the disease has emerged in a major way in the upper
midwest.
We anticipated that this virus would move through the
country. It's the reason that over the recent years we've
provided support to all of the 48 continental State health
departments to enhance their capacity to deal with this
problem. We have developed diagnostic laboratory tests that are
now in place in all the State public health laboratories, and
we've trained people to use them properly. This is an excellent
example of why people should care very much about the capacity
of their State public health laboratory as well as their State
public health--or the State public health department in general
and also the capacity of their local health departments.
Each of the previous 3 years following the transmission
season we have held meetings with State and local partners
initially to develop the initial set of those guidelines that
you allude to, and then during the past 2 years to update and
refine those. The pattern of movement up until this year had
been to the south and then westward in the southerly States. So
we're not surprised that it has appeared in the upper midwest,
but it points out the need to have surveillance in place so
that this virus can be tracked.
Mr. Souder. Since there was some occurrence moving toward
2001, what's--already--what's in the midwest, part of the
question would be why--how do you determine when to do as a
predictive agency as opposed to a rec--in other words, did you
have no evidence, either from FDA or bird death research or
suggestions of mosquito patterns, that when you had the first
signs that this could all of a sudden became a major wave--
because this isn't like a--the signs were coming, and all of a
sudden it's overwhelming, I mean, the numbers.
Dr. Hughes. Right. Well, Dr. Lumpkin and I have talked
about this, and as I'm sure he will tell you in his testimony,
the disease in the Illinois area is behaving very much like St.
Louis encephalitis, caused by a virus that's a cousin of West
Nile, behaved back in 1975 when it caused a very large epidemic
there. So in that sense, I mean, there's ample evidence
historically that this is, for reasons that we don't fully
understand, an area that is prone to mosquito-borne diseases.
So, as I said, we had made investments in strengthening the
public health capacity in those areas, and happily so.
In terms of prediction versus reaction, I've learned over
the years that these microbes are pesky critters, and they're
extremely difficult to predict exactly what they're going to
do, particularly when they are either newly recognized or
emerging in a new area. At CDC we feel that the public health
action starts with active aggressive surveillance that requires
the clinical community and the public health community be tied
closely together. This is true whether we're dealing with
antibiotic-resistant and vector-borne disease or the threat of
bioterrorism. It's very important, and we put a lot of
resources into that. It doesn't stop there because all of these
emerging diseases raise a lot of research questions, and they
stretch our capacity to deal with them.
In terms of research issues, one of them relates to
prediction and modeling, and that work is very, very important,
but as always, it is a tradeoff with limited resources in terms
of how to most effectively utilize them.
Mr. Souder. Does the prediction usually lose out in the
budget debate?
Dr. Hughes. Well, I can't comment on that. I think we go
with the things that we think are most critical, and right
now--because, you know, predictive modeling would not have told
us that hanta virus was going to emerge in the Southwest in
1993, nor would it have told us that a terrorist was going to
use the U.S. postal system to disseminate anthrax. So we have
to be, both on the clinical side and on the public health side,
on high alert.
Having said that, we need to think about diseases in other
parts of the world to which we are vulnerable, and there are a
number of examples. If we were talking 5 years ago, we might
have had West Nile encephalitis on our list. I can tell you we
should have another related virus, Japanese encephalitis virus,
which causes very severe disease in much of Asia. That should
be on our list. That would be, could be introduced. Recent
experience in Virginia reminds us that malaria can appear in
this country. We have vectors that are capable of transmitting
malaria here.
So there's a long list. There's the recent experience with
nepa virus encephalitis, Malaysia and Singapore, a devastating
biodisease that affects pigs and spreads from pigs to people,
that would be a major problem if that were to be introduced
into the United States. So we have to pay attention to problems
in other parts of the world. We have to make determinations
about diseases that could be introduced in ways in which we
might be vulnerable to them. So it's a very important part of a
great big puzzle.
Mr. Souder. Dr. Goodman, do you have any comments?
Dr. Goodman. No. I really am very supportive of everything
that Jim said. The way we try to interact with this is by
taking the kind of surveillance data and predictions that our
colleagues at CDC are so helpful with,and working with CDC and
NIH periodically--and here I'm talking with respect to blood
safety--periodically looking at the potential agents that are
out there, getting a feeling for what the risk may be from
them, again in the best way we can with respect to prediction
and the disease incidence that's going on, and to try to be as
prepared as possible.
Again, do we need to learn new lessons from what has
currently occurred? Well, we certainly should try to learn as
much as we can from that. Can we effectively use additional
resources to move these--to increase preparedness at all times?
That's something we want to look at very carefully, too.
Mr. Souder. Thank you.
Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman.
Gentlemen, what--I mean, this is not a new disease, and I
was just wondering, why is it, do you think, that we have not
been able to--our counterparts in foreign lands have not been
able to develop a vaccine for this?
Dr. Hughes. I think in large part it has not been viewed as
a priority in other parts of the world where this disease
occurs, recognizing, as I am sure you do, that in Africa where
the disease first appeared, of course, the continent's
devastated by HIV infection, by TB and by malaria. So you could
see how on their radar screen, you know--West Nile virus would
be pretty far down the list. With the introductions in Eastern
Europe and in France and in the Middle East, it's been
introduced. I don't think it's had, I mean, like the dramatic
impact that it has here, and it's been a problem that has kind
of died down after a year or 2, and so it hasn't gotten in
those countries high on the priority list either.
Mr. Cummings. Do we have a--do we--do you anticipate we'll
have a vaccine for this any time soon?
Dr. Hughes. Well, Dr. Fauci and his colleagues at NIH are
supporting a lot of research around vaccine development, and
the results of some of the candidate--of the work with some of
the candidate vaccines are quite promising. But it does take
time to bring these vaccines through appropriate testing to
production and marketing. It's--I know it is a very high
priority for them, and we see it, as I'm sure Dr. Goodman does
as well, as a high priority.
Mr. Cummings. I've noticed that when we had problems in
Baltimore, the--with the mosquitoes, they did the spraying. And
I guess that's what they usually do. They spray?
Dr. Hughes. Well, there are a number--what we try to
promote is what we call integrated pest management, and that
has a lot of components to it. It has--it starts with control
and reduction of sources, and that's where people, individual
members of the public, have an important role to play in terms
of taking steps in their living environments to reduce settings
in which these mosquitoes can breed.
Surveillance of mosquito populations is very important.
Larval control is important. That can begin much earlier in the
year. Spraying is somewhat of a last resort which is done when
the mosquito populations proliferate where there is
transmission to humans, and it comes at kind of the end of the
intervention spectrum, if you will.
Mr. Cummings. And is that--have you found that the spraying
is effective as far as preventing cases; in other words, in
places where they spray?
Dr. Hughes. Well, you're widely raising the need to
rigorously evaluate interventions that are done.
Mr. Cummings. And I understand you want to do stuff before
you get to spraying. I understand that. It's just that, I mean,
I just see all the effort that goes into it, and I think that's
basically what the public sees. I mean, you get--you know, you
hear on the radio, on the radio and television, don't let water
sit still and all that kind of stuff. I know that. But I'm just
trying to figure out--you know, I'm always interested in
measuring what we do so that we can determine whether or not
we're being effective. And so when I see in the city, for
example, these trucks going through all-night spraying all over
the place, I'm just wondering, as a result of that, are we
seeing a--I mean, do we--are we--can we tell whether we are
preventing or not?
Dr. Hughes. Well, again, it is an excellent question, and I
wish I could answer that concisely, but what we have seen now
down in Louisiana and Mississippi is the epidemic has peaked,
and it has fallen off. They have taken very aggressive control
measures there, but those include public education campaigns in
Louisiana. They have the Fight the Bite program that they think
has been very effective. But at the same time it is a
multifactorial set of interventions, so it is a bit difficult
to tease out in terms of whether the reduction of transmission
is more because of public education and the public response
vis-a-vis, you know, use of insect repellent versus staying
indoors at dawn and dusk versus a continued larviciding versus
introduction of adulticiding.
Mr. Cummings. Let me just ask you this: In the death of the
kidney transplant patient I mentioned a little bit earlier in
Baltimore, it was reported that the organ donor tested negative
for the West Nile, but it appeared that the blood the patient
received may not have been tested. What, if any,
recommendations is the FDA making to blood collection centers
and hospitals regarding the testing of donated blood?
Mr. Goodman. OK. Well, you have asked an important
question, which is how with can we deal effectively with the
potential threat through the blood supply. I would say that in
the investigation of that case, donor samples that exist are
being retrieved to be studied to see if any of those donors may
have been infected and may have been involved in spreading this
to this individual who developed West Nile disease. So that is
being investigated. But as a more general question, what we
have been doing is taking the steps that we now have available
to us to reduce that risk, and those steps, such as they are,
we are taking aggressively, but they are not perfect and
complete at this time.
I mention that, for instance, to try to remove from the
pool of potential blood donors those who might even have a mild
illness that could be West Nile virus, we think that is
helpful, and that was something we worked on a couple of months
ago with the blood community and our alert, providing guidance
about those groups of individuals who soon after blood donation
may become sick so that they can be tested and their product
withdrawn.
But as I had mentioned, and as I think you are focusing on,
that does not deal with the issue of those individuals who may
have no symptoms at all, but unbeknownst to them have--after
mosquito bites for what we believe a short period of time have
virus presence in the blood and potentially could transmit this
to somebody, causing serious disease. And for that, what we
really need to do is to be able to screen donor blood in real-
time, ahead of time, to reduce the risk of transmission to
others, and since this problem became apparent, we have been
working very hard and closely to bring that quickly toward
reality.
The positives on doing that are that over the last years,
as this has become West Nile virus, in general a public health
problem in this country, there has been investment and work in
diagnostic technology, some of which is very relevant and
promising for blood screening.
The other--you know, what I should mention here is this
isn't like the simple--what we would need to do isn't like the
simple blood test that one would go to one's doctor and get,
which might measure your body's response to a virus. OK, that
is what you have, that is your diagnosis. That is the
diagnostic test that Jim mentioned that the State health
departments perform. That's relatively straightforward. To
detect it in the blood, we need to detect it before the body
has even responded to it, so we need to detect the presence of
the virus itself, and that involves much more sophisticated,
demanding tests to detect tiny amounts of the genes of the
virus, amplify them to a level that we can detect them.
As I said, the good news is that those technologies exist.
They have been developed to a certain point. And another very
good piece is that FDA and the blood industry and the medical
diagnostics industry have taken exactly that approach over the
last several years, and now all blood in the United States is
tested with those kinds--same kinds of tests for HIV and
hepatitis C, which has reduced the risk from those diseases in
transfusion down to 1 in a million to 1 in 2 million.
Mr. Cummings. I've got to ask you this, and then this is my
last question.
Dr. Goodman. Sure.
Mr. Cummings. And try to put this in lay terms, if you can.
You know, like some people, if they eat certain types of food,
shellfish or whatever, it is like they get allergic to it while
everybody else is eating it, and there is no problem. Or MSG. I
have seen people just, I mean, swell up. Is this something
like--you know, when I think about all the people who get
mosquito bites and are not affected, is there something--you
may have already answered this. Is there something special in
these people that you have noticed that is common? Are you
following what I'm saying? And is that----
Dr. Hughes. Yeah. Yes. Let us both respond to that. Again,
another excellent question. You are doing very well in defining
a research agenda for addressing these infections.
We don't know why the elderly are the ones at greatest risk
for development of severe manifestations of the disease. We
don't--it is not surprising that immunosuppressed people such
as organ transplant recipients would be at risk for development
of severe disease. We see that with a broad range of agents.
But not every elderly person who gets infected with the virus
develops severe disease.
So, as you say, why do some and not others? There are
clearly other factors that play, whether it is behavioral
factors or genetic factors or other drugs that a person might
be taking or--you know, it is very important that we try and
determine that, but we most definitely don't have all the
answers.
Mr. Cummings. Thank you.
Mr. Souder. Congresswoman, Ms. Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman.
In the 1980's, the CDC provided Iraq with a number of
biological samples, including West Nile virus. I have two
questions. One is, has the CDC--does it commonly get requests
from countries around the world? And is there any possibility
of any connection between that virus that was provided to Iraq
earlier and what's the epidemic in the United States right now?
Dr. Hughes. Thank you actually for asking that, and let me
respond. I will take your second question first, if you don't
mind, and that is, given that West Nile virus strain was
supplied to Iraq back in the 1980's, does that have anything to
do with the current outbreak? And the answer is no. The strain
that was provided is not closely related to the strain that is
causing the current outbreak, which is one that was recognized
in the Middle East back in 1998, and it is the one that is
uniformly present, so far as we know, with the studies that
have been done to characterize the genetic structure of the
virus; that all the virus in the country currently, as far as
we know, is related to that strain that appears to have had an
origin in Israel using molecular techniques.
Now, the other part of your question is excellent.
Ms. Schakowsky. Yeah. But did you just say that it does
seem to be--we are finding it in Israel, the strain related to
that which was provided to Iraq in the 1980's?
Dr. Hughes. No. The strain in the United States is
virtually identical to a strain that was first recognized in
Israel in 1998.
Ms. Schakowsky. I see.
Dr. Hughes. It is not closely--neither of those is closely
related to the strain that was sent to Iraq.
Ms. Schakowsky. Thank you.
Dr. Hughes. So that is a very, very important point.
Now, the question about is this important to work with
colleagues in other countries, it absolutely is, and the West
Nile experience illustrates that. Fortunately, CDC colleagues
were involved in investigating a West Nile outbreak that
occurred in Romania back in 1996, and from that we learned some
lessons that have been helpful in responding to the
introduction here.
Another story that might be of interest to you is with
hanta virus pulmonary syndrome, again that disease that was
recognized in the Navajo reservation in 1993. We were able to
recognize that only because we had the benefit of reagents
developed by DOD, Department of Defense, supported researchers
who focused on the problem of another severe hanta virus
infection that occurred in Korea and infected a number of U.S.
soldiers during the Korean War. Because of that work, which is
research in another part of the world, we actually have
reagents that could be used that cross-reacted with the virus
that occurred here, and it was through that happy coincidence
that we were involved in the cross-reaction that unusual
outbreak was recognized and the agent identified within 7 or 8
days of notification of the first cases.
We at CDC are involved in a global network that is
sponsored by the World Health Organization that consists of
collaborating centers that are focused on a broad range of
diseases, starting with influenza. And data from that network,
which we support through provision of reagents and in training
of scientists around the world, generates the data that we use
every year and in collaboration with our colleagues at FDA to
formulate the recommendations for the composition of the annual
influenza vaccine.
So this idea of collaborating and working with scientists
in other parts of the world is very, very important. Having
said that, we all recognize in the current world in which we
live, this has to be done with great care and in compliance
with the existing regulation. So we take this very seriously.
Ms. Schakowsky. Well, I would hope that there would be a
renewed look. I am reading from a news report that says that
invoices from the 1980's included in the documents read like
shopping lists for biological weapons programs. And I guess
some of the material was delivered directly to--the companies
sent the bacteria to the University of Baghdad, which U.N.
inspectors concluded had been used as a front to acquire
samples for Iraq's biological weapons programs. The CDC,
meanwhile, sent shipments of germs to the Iraqi Atomic Energy
Commission and other agencies involved in Iraq's weapons of
mass destruction programs.
So I am assuming that we are reviewing wherever we are
sending anything right now?
Dr. Hughes. Well, we absolutely are, and we are making sure
that we are in compliance with the current regulations. And we
work closely with the Department of Commerce, which issues
export permits, and there is a list of countries to which we
don't send anything. But things are different today than they
were in the mid to late 1980's.
Ms. Schakowsky. I understand. But we don't want it to quite
literally come back and bite us.
Dr. Hughes. We agree.
Ms. Schakowsky. Mr. Chairman, can I ask one other question?
Are we going to do another round? OK.
Regarding Illinois, you know, though we are pleased that
there, on September 30th, was more money freed up, if we look
at other places where they have less of a problem with West
Nile, I just--maybe you said this already and I missed it--a
formula for how you would distribute funds particularly for
this. And I understand that the September 30th had to do with
reserve revenues, and now that money was distributed on the
30th, are there more--are we out of reserve revenues to do
that?
Dr. Hughes. We have a little more money left that can be
used through the rest of this transmission season. It is not a
lot. We are trying to be responsive to specific requests from
States who continue to have a problem, and, in fact, Dr.
Lumpkin and I were talking about that before the session began.
Ms. Schakowsky. Great. Thank you very much.
Mr. Souder. Do you have some additional time that we can do
a second round with you?
I have a couple of different type of questions. One is do
you agree that the rate of spread--when you looked at the cases
of this around the world, that the rate of the spread in the
United States is occurring faster that in previous cases in
other countries?
Dr. Hughes. Well, I can't see the original map, but you may
recall from the colors that the impacted geographic area each
year has more than doubled. There--thank you. There you can see
it. Again, blue were the four States in 1999. And you can see
what happened in 2000 in green, 2001 in red, and 2002 in
yellow. The virus in Romania, as far as we know, the outbreak
that I mentioned in the mid-1990's, did not spread beyond the
country of Romania. So, obviously, this is a much more dramatic
spread.
See, the virus, though, had been present in Central Europe
from time to time in the past. It is brand-new to the Western
Hemisphere. So, not only do people not have any immunity to it,
our bird populations don't have any immunity to it. They may be
developing it along the eastern seaboard now after several
years of experience. But certainly, the bird populations in
Indiana would have had absolutely no experience with this virus
and would have no immunity at all. So I think in part that
contributes to the spread as well as the bird migration
patterns.
Mr. Souder. Could the strain that we sold or gave or
whatever to Iraq have been genetically altered?
Ms. Hughes. It would be very difficult for me to imagine
how that strain could have been converted into this particular
strain.
Mr. Souder. We may have some followup questions. It is a
very potent question being asked in a lot of places, given the
spread and the rapidity of the spread.
Let me ask another line of questions, and once again,
looking at the international cases and even our United States,
basically, it seems to be within the last few weeks we are
really looking at the blood supply in the organ donors. Did
that not happen anywhere else in the world? Did it not happen
in other years? Why is this all of a sudden an intense focus?
Dr. Goodman. Well, it is an excellent question that we have
talked a lot about at all hours of the day and night. We do
not--there were no previous case reports from any country or
from the United States that showed transmission of West Nile
virus by either organ transplantation or transfusion. So that
is part of the background and kind of the background that led
to, although this was on our radar screen, it seemed to be a
low risk. So that is a good question.
In terms of what is different, I think there are
potentially a number of factors. I think that, as Jim just
alluded to, this virus is spreading rapidly in populations with
no previous immunity, human, bird, and others, and the sort of
crescendo and just sheer number of cases and burden of disease
is quite high at this time.
So, certainly increased numbers of people are at risk of
being infected, and even though those--the number of people
with disease and symptoms is small--or not small. I mean, it is
remarkably larger this year than previous years. But we do know
there is a much higher ratio of people who never have any
symptoms and get infected.
So I think part of this is the sheer burden of disease, but
another part of it may reflect things about our population and
medical progress, the degree to which we use health care and
attendant blood transfusions, the degree to which organ
transplantation has become a common and lifesaving event in
this country, and the fact that, at least in those cases under
investigation now, the majority of them are individuals--not
all, but the majority who would be expected to have immune
systems that are not functioning well.
But it could be that in other countries some transmission
in this route occurred, but may not have attracted attention
because it wasn't being looked for in the same way, or may not
have caused a severe disease, because if it were in healthy
people, it may be that even when you get it by the blood, a
healthy person many times will not develop symptoms.
But these are good questions, and we are working with CDC
and the blood community to rapidly mobilize studies to help
answer these questions.
Mr. Souder. And I want to make sure I reinforce on the
record that even with the epidemic outbreaks in certain parts
of the country, more people die from--and potentially die from
not having blood transfusions than the risk at this point. And
this could be--we don't want to have a panic about people
giving blood or taking blood, because that is a daily
dependency in our hospital and medical system in the United
States, but we want to try to make sure that it doesn't explode
and get out of control.
I have two other brief things I want to address, sir, that
are important to us in Indiana that can be extrapolated. The
season is generally considered mosquito season, late summer,
but we have some sign that we could see the first cases in the
early spring season. Do you see that in other parts of the
midwest, other parts of the country? And what do you--when you
earlier referred to season, how do you define that? And are
there preventative things you can do before the early spring
season so we don't see--right now in my area it is concentrated
in one county, but so that it doesn't explode to the rest of
the counties around it?
Dr. Hughes. Yes. The early case this year occurred in the
southern part of the country, which I guess wouldn't be
surprising given the temperatures.
I think, in terms of thinking about next year, you know, we
definitely all--you know, this--dealing with this, as I think
has been apparent from the discussion, requires a real
partnership between people in clinical medicine and in public
health; and within public health, among many partners at the
Federal level, the State level, and the local level.
We are going to continue to learn. We have to look at areas
that have been particular hot spots this year, as in the case
in two parts of Cook County and in the area that you referred
to in Indiana, and anticipate that next year they may again be
at high risk for transmission.
And so mosquito control efforts that ought to begin early
in the season--again, it is this integrated pest management
early in the year, source reduction, use of larvicides when
appropriate to try to keep mosquito populations down is very
appropriate and should be particularly intense, I would submit,
in these areas where transmission have been highest this year.
So we will need to be sure that resources are provided in
advance so that work can begin early in the year.
Mr. Souder. One last, and I will yield to the other Members
for additional questions.
I have been trying not to be offended by the senior
designation, because when you turn 50, you get the AARP thing;
and I am wondering whether that is the definition of senior you
are working off of, because I believe several of our deaths in
Allen County were in the 1950's, not in the 1960's; 1953 I
think was--'56; and that I also know some who are very sick who
are between 25 and 35. They weren't either very young or very
old, and they were in very good physical shape.
That I understand, the potentially weaker immune systems of
the elderly or the very young. Clearly there has been a lot of
focus on teens. But this--going back to Congressman Cummings'
question--seems on the surface to be a little more generic.
Could it be, well, blood sugar? Are you looking at other things
in the system? Because it doesn't seem to quite have this
pattern in my area.
Dr. Hughes. Yes. Thank you.
Let me give you just a little bit of data and say that in
public health we often think of populations. So if you look at
the median age of people who have died this year, it is
actually 79 years of age. Now, what the median is, it is just
right in the middle. That means that 50 percent of the people
are older and 50 percent of the people are younger. The
youngest person that we know of that has died of West Nile this
year is 27 years of age. I can't tell you offhand where that
tragic death occurred. But, you know, on average we can say
that it is the elderly people that are at greatest risk for
severe disease and death, but that risk is not limited to
people above a certain age.
Mr. Souder. Thank you.
Mr. Cummings.
Mr. Cummings. Is this easy to diagnose?
Dr. Hughes. It is easier to diagnose today than it was 4
years ago. Four years ago, it was extremely difficult to
diagnose. And you may, in fact, recall that when the initial
cases were recognized by an alert clinician in Queens, reported
to the New York City Health Department, investigation was done,
specimens were collected and analyzed, the initial results
suggested that this was St. Louis encephalitis virus in a new
part of the country, in New York City. We were misled initially
by the cross-reactivity because of the genetic relatedness of
these two viruses. So we had to go back and develop tests
specifically for the diagnosis of West Nile infection, and
develop those tests, develop the reagents that are required to
run them, get them to the State public health laboratories, and
get people trained in how to do the tests, and at the same time
maintain confirmatory laboratory capacity at our CDC laboratory
in Fort Collins.
So, it is easier today. The public health laboratories have
the capacity. There are companies working on developing tests.
We need licensed tests that are more widely available that
could be used in clinical laboratory settings. So we are not
totally there.
Mr. Cummings. Is there any such thing that if I got to a
doctor early, does that make a different at all?
Dr. Hughes. There is no effective specific treatment today
for West Nile encephalitis, so it would make a difference to
that proportion of people who were going to go on to develop
severe illness, because obviously the earlier someone is
recognized to have a severe illness, the sooner proper
supportive care can be provided. So in some people it--
certainly, the earlier you are diagnosed, the better off you
are.
Mr. Cummings. The money that the CDC funds, what--I notice
in fiscal year 2000, $10 million, to fiscal year 2001, $25
million. And then it says 2002--2002, $46 million. What is that
money used for?
Dr. Hughes. Well, of the $46 million, $35 million has gone
to the State and local public health jurisdictions, and there
it is used for a number of things. It is used to strengthen
surveillance programs, it is used to support the delivery of
these diagnostic laboratory tests that we have been talking
about, it is used for prevention and control programs and
outreach to the public. In some cases--although we don't
encourage this, in some cases some of that money has been used
by local jurisdictions for spraying.
Mr. Cummings. How do you all prioritize, I mean,
particularly with the spread? And is there something
comparable--has something comparable happened in the world to
what's happening now in the United States, in other words, this
extent, and seems to be growing quite rapidly?
Dr. Hughes. OK. In terms of the budgeting, you know, there
is no precise formula that's used to determine the allocation
of funds, and as has been pointed out, the funding to the State
and local jurisdictions this year occurred initially, and then
there have been three supplements following the initial
allocation. Those supplements have really been targeted toward
the--or been determined really by the behavior of the epidemic
and the movement of the virus. So, in fact, I am actually glad
we did it that way, because if we had used all available
resources back early in the year and put it into the South
where the problem had been last year, we would have had
precious little left over to deal with the progression of the
virus.
We listen very carefully to what the States tell us about
what their priority needs are, and we try to be as responsive
to those as we can be.
In terms of your question about the geographic movement
over large areas, I think we are going to have to stay tuned
for that. The virus has spread to Canada. It has been
identified in the Cayman Islands. The Caribbean is certainly at
risk. Mexico is certainly at risk. This virus may be with us in
the Western Hemisphere, but time will tell. It is another
reason why working with colleagues in other countries is
important to do, and we have tried to do some of that to
strengthen diagnostic capacity in the hemisphere, working with
the Pan American Health Organization and others.
Mr. Cummings. Has that been very helpful?
Dr. Hughes. I think we have made progress in terms of
increasing capacity, at least in some countries, to diagnose
this. More work needs to be done, clearly.
Mr. Cummings. Just the last thing. When you have folks in,
say, small towns, and people come in with West Nile, how do
you--what are they--I assume that folks come and seek
information from the CDC, doctors, whoever, and trying to
figure out, well, what do we do? The panic that the chairman--
the concerns that the chairman mentioned about sending your
kids out to the baseball game and stuff like that. I mean, what
is the CDC saying to folks like that?
Dr. Hughes. Well, again, thank you for bringing that up.
This is this communication issue that is so critically
important. You know, we certainly have this emphasized to us in
the response to the anthrax attacks last year. It did not go
well. Because clinicians are so important in the initial
recognition of these new syndromes, as we have talked about--
and in fact, Dr. Gerberding, our Director, likes to talk about
the golden triangle of close relationships between people in
clinical medicine, people in the health care delivery system,
and people in public health. Those cultures are somewhat
different, and we must bridge the gulf between those different
groups, and it is something that both she and I are very
passionate about. And hopefully you are seeing some evidence of
us becoming much more proactive on the professional educational
side.
Then equally important is the public educational needs.
People really need to understand. I mean, we have their
attention now, so we need to take advantage of that to deliver
to them practical advice that can help demystify some of this a
little bit, and also give them constructive guidance about
measures that they can take to reduce their risk. And we are
trying to do that in a number of different ways.
Mr. Cummings. Thank you.
Mr. Souder. Congresswoman Schakowsky.
Ms. Schakowsky. I just have one quick question. Is there
any reason you think that Illinois would have more cases than
other States?
Dr. Hughes. I would ask that you ask Dr. Lumpkin for his
thoughts on that when he comes, but I think, for whatever
reason, as I had mentioned earlier, some of the areas of
highest incidence this year in Illinois are the same areas
where the incidence of St. Louis encephalitis was quite high in
1975. And so to me it must have something to do with the nature
of the environment there and its interaction with the bird and
the mosquito populations.
Mr. Souder. I want to thank each of you. I would encourage
you to, and let us know, what we need to do on the budget side,
because the initial funding request is flat level whereas we
had a big supplemental this year, and yet potentially this is
explosive. If 80 percent of the cases in Illinois are in Cook
County, it suggests that while Cook County is a big county,
that is only a small percentage of the State. In my
congressional district, Allen County is the biggest county, but
it is less than 40 percent of the district, and it is only a
small percentage of the State; yet, nearly 50 percent of the
cases are in one county, which suggests that it is not just
going to stay localized as we work with this. So we'd
appreciate working with you in addressing the midwest.
Thank you for your work. We will probably have a few
written questions. And, with that, thanks for coming.
Would the second panel then come forth. Dr. Lumpkin, Dr.
McMahan, Mr. Wichterman, and Dr. Akhter. If the second panel
could remain standing, we will do the oath at this time. If you
can remain standing, we will do the oath.
For those of you who were not here earlier, it is a
standard practice as an oversight committee that all our
witnesses are sworn. If you could raise your right hand.
[Witnesses sworn.]
Mr. Souder. Let the record show that the witnesses have
each answered in the affirmative.
We will first start with Dr. Lumpkin, the director of the
Illinois Department of Public Health.
STATEMENTS OF DR. JOHN R. LUMPKIN, M.D., M.P.H., DIRECTOR,
ILLINOIS DEPARTMENT OF PUBLIC HEALTH; DEBORAH McMAHAN,
COMMISSIONER, ALLEN COUNTY HEALTH DEPARTMENT, FORT WAYNE, IN;
GEORGE WICHTERMAN, CHAIRMAN, LEGISLATIVE AND REGULATORY
COMMITTEE, AMERICAN MOSQUITO CONTROL ASSOCIATION; AND MOHAMMAD
AKHTER, EXECUTIVE DIRECTOR, AMERICAN PUBLIC HEALTH ASSOCIATION
Dr. Lumpkin. Thank you, Mr. Chairman, and members of the
committee. Thank you for the opportunity to present before you.
This year the Illinois Department of Public Health is
celebrating its 125th anniversary as a State agency.
Interestingly enough, our agency got its start in 1877, in
response to an outbreak of yellow fever, which is a mosquito-
borne illness, and as such, just as we started, now at our
125th anniversary we are facing a major outbreak.
Today we have the results of our testing. We now have 623
cases in Illinois and 35 deaths. West Nile virus has been found
in every single county in the State of Illinois, all 102
counties, in birds, mosquitoes, and, in most of those counties,
also in people. We are past the peak. Our numbers of cases and
the date of onset have peaked somewhere in the beginning of
September, yet we are continuing to see cases, and we expect we
will be seeing cases because of the delay in diagnosis and
reporting for some weeks to come.
And what we have seen is very much what we saw in 1975,
when there was a major national outbreak of St. Louis
encephalitis. And during the outbreak, the majority of the
cases--a large number of those cases occurred in Illinois, more
than any other State, where we had almost 600 cases.
As we began to look at this in perspective, something that
was said by Joshua Lederberg, who is a Nobel laureate, that
``nature is not benign; the survival of the human species is a
not preordained evolutionary program;'' and that our public
health system has to be strong and be able to respond. And the
challenges of West Nile, in fact, demonstrate why we need to be
prepared.
In 2001, West Nile had a national total of somewhere in the
neighborhood of 157 cases and 15 deaths. There have been as
many cases in Representative Schakowsky's district as there
were in the entire United States prior to this year, and that
includes 1999, 2000, and 2001. So obviously, what we are facing
this year is dramatically, dramatically different.
We as a State began to get prepared based upon--with
resources provided us by Center for Disease Control, and last
year we prepared our first West Nile plan prior to having any
cases in birds or in mosquitoes, and that plan was distributed
throughout local health departments. We began funding them to
develop their own West Nile plans and began to respond.
We developed a task force of State agencies that began
meeting last fall after we had our first positive bird and
began to put in plans. Recognizing the experience in 1975, we
built upon a strong foundation of surveillance that have been
in place since 1976 where over 5,000 birds a year were trapped
and sampled, looking for St. Louis encephalitis, western equine
encephalitis, eastern equine encephalitis, and this year for
West Nile virus. That system began to indicate that in July we
were having quite a significant problem.
Thirty-five of the most involved counties and local
jurisdictions have spent over $5 million this year on mosquito
abatement. An additional $3.5 million was made available by
Governor George Ryan to be able to address this issue. Once
again, it has been a system that has indicated that our public
health system has been able to respond and responds quite well.
But what we have done is we have borrowed from Peter to pay
Paul. These funds that were made available--because there are
no emergency public health funds in our State, and generally
not in the Nation--were taken from an account that is used to
fund local health departments to do food inspections and do
infectious disease outbreaks, and what we did is we took the
money from the fourth quarter. So come April we are going to be
in very short supply of funds to support our public health
programs at the local level.
We have to look at the lessons from this year as we begin
to look toward next year. Obviously, we need to look at ways
that we can support our public health infrastructure. Through
the support of Congress and the administration, a significant
amount of funds were made available to the States.
Unfortunately, it was really too late to be able to shore up
our public health system. In our laboratory--for instance, the
reports on West Nile began coming in later and later. We
started to check into it. It was because the person who was
running it, Rosie, in the laboratory was doing it on a hand
calculator, our inability to implement that. Now, with the
funding that has been made available, we are going to start
automating that, but it takes time, and it takes persistence,
and it takes consistency. Trying to buildup for decades of
neglecting our public health system cannot occur overnight and
cannot be done with one single shot.
We need to look at how to support that public health
system. We also have to recognize that public education is the
key. In Representative Schakowsky's district, when we went
there with the Centers for Disease Control to look at where the
mosquitoes were coming from, the first two homes we went to had
mosquito larva growing in containers that were in the yards of
individuals. No mosquito abatement district can address those
particular problems. It has to be a partnership between
government and individual citizens, and that means we need to
expend the resources to do the kind of research--I mean, the
kind of outreach and public information that will help people
realize how important they are in preventing the spread of this
disease.
Research is also key. Public health, I believe, has once
again responded, but will need assistance to respond again, and
I think having hearings such as these are very important to
highlight the problems and begin to address the needs for next
year. Thank you.
Mr. Souder. Thank you for your testimony.
[The prepared statement of Dr. Lumpkin follows:]
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Mr. Souder. Dr. McMahan is next. I want to thank you for
your aggressive leadership in Allen County on this issue. And
basically anybody who doesn't understand right now in Fort
Wayne, my hometown, that they need to empty out every container
and sweep off if there is any puddle in their driveway, you
have done an excellent job of working to get that information
out, and I am looking forward to your testimony.
Dr. McMahan. Thank you.
Good afternoon, Mr. Chairman and members of the committee.
The national impact of West Nile virus has generated intense
media interest this summer. The evolving numbers of human cases
and deaths can be found on a regular basis on the front pages
of local and national newspapers as well as crawlers on
national news programs. However, the local impact of the West
Nile virus is not often explored or attended to, and we thank
Chairman Souder and this subcommittee for inviting
representatives from the front lines on the war against the
West Nile virus to testify as to the impact this infection has
caused in our community.
In Fort Wayne, Indiana, a community of approximately
330,000, we have identified 51 human cases of West Nile virus
as of September 30th. This gives our area an attack rate of
15.4 cases per 100,000 population. It is important to note that
West Nile virus has not been a benign illness for most of the
people infected in our community. One of our residents who has
been severely affected with West Nile virus had this to say
about the virus: If I could say one thing to someone about West
Nile virus, it would be that people should not take this
lightly. I just wish I knew how long it is going to last.
Over 40 percent of the people identified with West Nile
virus were hospitalized, and two patients required further
treatment in a rehab facility after discharge from the
hospital.
There has also been a significant economic impact locally
due to the lost productivity by the 65 percent of those
identified with West Nile virus who were unable to work while
they were ill. In addition, considerable medical costs were
incurred by all of the patients identified with West Nile
virus, in addition to the 40 percent who were hospitalized for
supportive care. But most importantly, there is no way to
measure the grief caused by the three probable deaths due to
the West Nile virus in Allen County; 37 spouses, children,
grandchildren, and great-grandchildren have been left behind to
try to understand how a simple mosquito bite could have killed
their loved one.
From a resource perspective, our local health department
has spent over $285,000 fighting the West Nile virus this
summer. We have had to divert human resources from ongoing
public health functions to keep up with the bird and mosquito
surveillance and treatment, and the human case investigations.
Although expensive, we do believe it has been effective at
limiting the number of additional human cases of West Nile
virus in our community. However, it is important to note that
childhood vaccinations, restaurant inspections, septic system
failures, disaster preparedness, and other public health
responsibilities continue during this outbreak.
Infectious disease outbreaks serve as an important
opportunity to understand the strengths and weaknesses of a
community's and a nation's ability to provide an integrated
response to identify and contain the offending agent. What we
have learned thus far in our community is that while we are
rich in talent and communication, we are significantly lacking
in the human and economic resources locally to implement the
necessary interventions.
Our department, too, began planning last year for the first
occurrence of West Nile virus in our community. West Nile virus
requires a collaborative response from both environmental and
medical specialists. We worked at length to develop a science-
based comprehensive plan for the surveillance and treatment of
West Nile virus in our community. Our Vector Control Division
has worked extensively to identify and treat environmental
sources of mosquito breeding. They have also worked in
collaboration with the laboratory of both our department and
the Indiana State Department of Health to perform timely bird
and mosquito surveillance to identify areas of increased risk
of human transmission.
Our medical community, whom we began educating last year
about the West Nile virus, has done an exemplary job of
identifying patients infected with the West Nile virus. This in
turn has allowed our public health nurses and environmental
investigators to quickly identify and treat high-risk areas
surrounding the human cases, thereby preventing even more of
our residents from becoming infected with the virus. Our public
information officer and speakers bureau has provided timely
epidemiological information and educational materials to both
the media and the public. And finally, our board and public
officials have been prompt and responsive in allocating the
funding necessary to contain this disease, despite the
significant economic hardship it has placed on the county.
West Nile virus has served to highlight one of the most
important aspects of any infectious disease outbreak, the
unpredictability of bacteria and viruses. We have seen
significant changes in the West Nile virus this year, including
a striking increase in the number of people and animals
infected, the potential for transmission through organ
transplants and blood transfusions, and an increase in the
number of young people seriously affected by the virus.
Because bacteria and viruses have the ability to mutate,
the potential for large-scale outbreaks will always exist.
Therefore, humans will always be vulnerable to the potential
health consequences of infectious disease agents and the
extraordinary efforts needed to manage and contain the
outbreak. This vulnerability requires an infrastructure that is
sufficient in terms of human and economic resources so as to
provide the necessary flexibility to rapidly identify, treat,
and contain the infectious agent at every level.
Previous studies have indicated that our public health work
force is woefully inadequate to effectively manage routine
public health issues, let alone large-scale outbreaks. This is
particularly true in Indiana where our local and State public
health staffing rates are significantly less than the national
standard. Indiana has 46 public health workers per 100,000
population compared to the national average of 138 per 100,000.
Because the need is so great throughout the entire public
health system, Federal dollars are often not realized at the
local level. And it is important to remember that all outbreaks
begin locally. Federal and State funds are needed to develop
the public health work force such that we will not be in this
position when another perhaps even more deadly outbreak occurs.
In conclusion, public health serves as the interface
between environmental conditions in the field and the medical
consequences for patients seen in hospitals and doctors'
offices. The solvency of the public health infrastructure
reflects the values of the Federal, State, and local public
officials that allocate financial resources. Let us use the
West Nile virus outbreak and all the devastation it has caused
for the thousands of people infected throughout the country,
including the 51 people and their families identified at Fort
Wayne, Indiana, as an opportunity to establish mechanisms by
which we can develop and support our local, State and Federal
public health system.
Thank you again for the opportunity to present the local
perspective.
Mr. Souder. Thank you very much for your testimony.
[The prepared statement of Dr. McMahan follows:]
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Mr. Souder. Next we will here from Mr. George Wichterman,
who is chairman of the legislative and regulatory committee of
the American Mosquito Control Association and is from Lee
County. This is also going to be very interesting for my
district, because I, like many others, I go to Sanibel Island,
but at Fort Myers area, Sanibel, Captiva, and the areas just
north and just south basically have almost as many Indiana
license plates as Florida license plates in the spring. So I am
interested in hearing that from a local as well as your
national perspective.
Mr. Wichterman. Thank you, Mr. Chairman and members of the
committee.
Mr. Chairman, I would like to ask you, if at all possible,
would you please include my written statement into the record
as well what I am about to present.
Mr. Souder. Yes. We will have all your written statements.
And if you have other information you would like to submit
after you hear the full hearing, we will submit that also.
Mr. Wichterman. OK. Thank you, sir.
I am George Wichterman, chairman of the legislative and
regulatory committee for the American Mosquito Control
Association, and senior entomologist with the Lee County
Mosquito Control District in Fort Myers, Florida.
I would like to thank Chairman Souder for his leadership in
holding this important hearing regarding the Federal response
to West Nile virus and the challenges in addressing its spread
and impact on the Nation's public health. The American Mosquito
Control Association is a nonprofit international association
involved in supporting mosquito and other vector control. Our
mission is to provide leadership, information, and education
leading to the enhancement of health and quality of life
through the suppression of mosquitoes and other vector-
transmitted diseases.
The AMCA commends this subcommittee inquiry into the West
Nile virus. This disease represents a clear and present danger
to the public's health. Given the nationwide potential spread
of this disease, it is incumbent upon the Federal Government to
determine what must be done to prevent its spread and
ultimately eradicate it from our country.
The AMCA would request that as Congress studies the West
Nile virus situation, it consider several issues which
potentially affect the ability of our members to address not
only the virus, but other diseases as well. The first issue
concerns the shrinking supply of effective control agents to
address the pests which carry this disease.
As you may be aware, the vector control industry has a very
limited number of pesticide products available to treat
dangerous pests such as mosquitoes. Our use is not considered a
major use by the pesticide industry. Consequently, there is not
a lot of ongoing research development of new pesticides that we
can use. This volume of product we use is not remotely similar
to the amount of corn, wheat, cotton, soy bean acreage which
may be used in treatment for herbicides--as with herbicides.
For economic reasons, pesticide manufacturers tend to focus
on these other markets in developing new products. As a result,
maintaining the limited number of existing tools that we have
to combat vectors such as mosquitoes is of vital interest to
our members. These products are going through the
reregistration process before the U.S. Environmental Protection
Agency. In conducting those reviews, often vector control use
is immediately in jeopardy because it is such a minor use, and
registrants would rather focus their energies on other larger,
more economically valuable uses. Sometimes the registrant
simply cannot afford to address EPA's data needs for a vector
control product because the cost of the data outweigh the
return on sales of the product. EPA has one such pesticide
under reregistration that may be lost due to this economic
consideration, resulting in its cancellation.
Technically there was a section included in the Food
Quality Protection Act of 1996 which was intended to address
this situation. The public health provisions of FQPA
established the Public Health Pesticide Data Collection Program
administered by the Department of Health and Human Services to
develop data to support the continued registration of these
critical vector control products. Unfortunately, while this
potentially valuable program was authorized, no funds have ever
been appropriated for this program. DHHS has never even
requested funding for this program. Our repeated attempts to
try and meet with the DHHS Secretary's office on this important
issue have been rebuffed. It appears that the Secretary simply
is not interested in trying to tackle this issue. We have heard
that this is considered an unfunded mandate by the DHHS, and no
one in these economic times wants to consider unfunded
mandates.
AMCA submits that such an approach is wrong. The West Nile
virus and other vector-borne diseases are a clear threat to our
Nation's citizens. If we, the persons charged with dealing with
these disease outbreaks within each State, do not have the
requisite tools to do our jobs, the conclusion is self-evident:
More people will become exposed to these diseases, and
potentially more people will die from such exposure. We need
the leadership and assistance now of the Secretary of the DHHS
to work with Congress to secure the necessary funding for this
program. We need our limited supplies of pest controls tools
protected.
The second issue represents a legislative initiative which
was passed this week in the U.S. House of Representatives
entitled the Mosquito Abatement for Safety and Health Act, H.R.
4793, which would authorize grants through the Centers for
Disease Control and Prevention for mosquito control programs to
prevent mosquito-borne diseases. This bill would enable
political subdivisions of States to establish and operate
mosquito control programs where none currently exist.
As of today, mosquito and other vector control programs
throughout our Nation represent only 28 percent of the Nation's
counties. Many of these mosquito control programs are situated
in coastal areas of the United States, thereby leaving a
greater number of counties and municipalities unprepared for
this more ubiquitous task of controlling West Nile virus
epidemics. By providing appropriate funding to these entities,
entomological surveys or assessments may be conducted to
determine potential mosquito breeding areas, thereby providing
for the development of a plan for carrying out such a mosquito
control program. Technical assistance with respect to planning,
development, and operation of control programs would be made
available by the Secretary of DHHS, acting through the Director
of the CDC, for program coordination. The American Mosquito
Control Association supports this landmark legislation, and
strongly encourages your colleagues in the U.S. Senate to
support its passage through Congress.
As an organization of over 2,000 public health
professionals across the Nation, the American Mosquito Control
Association is dedicated to preserving and protecting the
Nation's public health. We respectfully urge DHHS and the Bush
administration to collectively work together to implement the
Public Health Pesticide Data Collection Program by providing
the appropriate funding which is necessary to preserve these
important public health products. And with your colleagues in
the U.S. Senate supporting passage of H.R. 4793, public health
professionals will be able to function in an effective manner
in order that they may protect our people and Nation,
especially the most vulnerable segments of our population, our
children and senior citizens.
Again, AMCA appreciates the opportunity to provide their
views. If the subcommittee has any additional questions, we
would be pleased to address them. Thank you so much.
Mr. Souder. Thank you very much.
[The prepared statement of Mr. Wichterman follows:]
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Mr. Souder. And for cleanup is Dr. Akhter from the American
Public Health Association. We appreciate your coming today and
look forward to your testimony.
Dr. Akhter. Thank you, Mr. Chairman, members of the
committee. My name is Mohammad Akhter. I am the Executive
Director of the American Public Health Association. We are a
membership organization of 55,000 professionals that work at
the State, Federal, county level to provide services to the
American people to make sure that their health is protected. I
am delighted to have this opportunity to be able to speak to
you.
You have heard all about West Nile virus, but now we are
going to talk a little bit about West Nile virus, but more
importantly talk about the future, the way we look at this
emerging and reemerging infection, and what kind of actions we
can all take to protect ourselves.
The world around us is changing. The ecosystem is changing,
populations are shifting, globalization has taken over, and so
the diseases have become global. Our last century's model of
treating disease is no longer relevant. For this century we
must substitute, we must add additional things to it to make it
effective to protect the health of the American people, and our
agencies are the very best. CDC, wonderful. FDA, excellent.
NIH, no other country has such an agency. And they work very,
very hard, they have done a superb job, and we are very
grateful we have such agencies.
But despite all their efforts, their actions started after
disease hit our shores, not before. We didn't do anything
preemptive. We were just sitting and waiting for disease to
come. And think about this: it is 3 years since the disease hit
our shores. How many scientists, how many people does it take
to really think proactively, that if HIV virus is transmitted
through blood transfusion, if Hepatitis C gets transmitted
through blood transfusion, is there a possibility that West
Nile virus may be transmitted through blood transfusion, so we
could start working and develop a test? Because we are not used
to being proactive. We just want to sit and wait for the case
to take place and then act.
And, Mr. Chairman and members of the committee, that is too
late. That is now no longer acceptable. And despite our best
efforts, we are unable to contain the outbreak. It has now
gotten to the heartland of America. It is going to be with us
for a long time to come and around our Nation. So we need to
really look at it a little bit differently, and I suggest that
we take four very distinct steps to deal with this situation
for the future.
First, we need to have good medical intelligence around the
world that we should collect ourselves. We can't rely on other
countries. They don't have good infrastructures. They don't
have good people to really do that. We need to know how disease
is moving around, where it is coming, so that we are warned
ahead of time so we could start taking actions. Developing
vaccines takes 3, 4, 5 years. Developing tests take a long
time. The sooner we are informed, the better we are in a
position to help other countries as well as help ourselves.
Second, we should be looking at the diseases that are
emerging and reemerging so that we should be doing research on
them. We should be doing some work on them. Private industry is
not going to do this work, because there is no benefit in them.
This is the work that needs to be done by the government, and
that should go on all the time so that we could look at how the
viruses are changing, what kind of conditions are changing, how
the virus might spread, what might happen in the future.
But the first thing we need, Mr. Chairman and members of
the committee, is a long-term, sustained thinking, not by the
people who are doing the work. They are too involved. FDA, CDC,
NIH, they are working too hard taking care of us all. We need
people who are retired, people who have the expertise, people
who come together to work on it as a think tank, who think,
scan the horizon all around us to see what are the potential
threats and what are the potential situations around the world,
and then come up and give us the information, give you the
information, Members of Congress, provide the administration
with the potential threats, make different modelings so we are
not caught by surprise that disease is spreading too fast, that
it has gone South, then it has gone West, when we should know
by modeling what kind of resources will be needed.
You shouldn't be asking professional people how much money,
and they say, we don't know, we just will see what happens.
Somebody should be calculating what kind of manpower will be
necessary to deal with the disease if it spreads around, and
that capacity we don't have in our country.
We are changing environments, Mr. Chairman. This is the
most important and pressing need, that there be a think tank
that looks for the future.
And finally, in concluding, we need to have, Mr. Chairman,
continuous capacity-building at the State and local level. My
good friends here have said and the Congress has provided the
resources last year. We need to continue to maintain that
capacity so that our people are able to take prompt action when
disease outbreak does take place to make sure that our people
are safe.
I greatly appreciate this opportunity, Mr. Chairman, to
come before you and members of the committee, and look forward
to answering any questions that you all might have for me and
my colleagues. Thank you.
[The prepared statement of Dr. Akhter follows:]
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Mr. Souder. Well, I thank you all. It has been very
informative for each of us.
Let me ask a couple of kind of basic questions first.
Mr. Wichterman, I presume you have a mosquito control
district in Lee County.
Mr. Wichterman. Yes, that's correct.
Mr. Souder. Have you had any West Nile in Lee County?
Mr. Wichterman. Yes. Mr. Chairman, I am from a mosquito-
controll district, and we cover roughly 1,000 square miles in
southwest Florida and Fort Myers, and we do have West Nile
virus indicated in our surveillance program, both in the avian
population as well as our sentinel flocks that we use for
surveillence for determining whether we have encephalitis,
whether it be St. Louis encephalitis or Eastern equine
encephalitis. But to date we have not had any human cases in
southwest Florida.
Mr. Souder. Why do you think you don't have any human
cases?
Mr. Wichterman. My best guess----
Mr. Souder. In other words, one of the things that somebody
from Indiana would immediately look at is basically Florida is
out of a swamp; you have huge migratory bird populations there,
with Ding Darling and all sorts of wildlife refuges. You have
more seniors. Why wouldn't you have any human cases?
Mr. Wichterman. That is an excellent question. My best
answer would be in the State of Florida there are currently 54
organized State-certified mosquito control programs out of the
67 counties in the State of Florida, and because each of these
mosquito-controlled districts maintain a surveillance program
like what you have been hearing earlier from Dr. Hughes, and
surveillance is key to finding out whether you are going to
have a problem or not, and surveillance helps to preclude any
human cases that you may have on the horizon.
Currently in the State of Florida, as of this past day we
have nine human cases of West Nile virus, but the cases are in
southeast Florida around Miami, up in west central Florida, out
in the western Panhandle of Florida, and up in north central
Florida, where some of these mosquito control districts are not
prevalent.
Mr. Souder. Let me move to Dr. McMahan next.
Could you for the record give a few pattern insights into
what you have seen in Allen County? I'm going to ask the same
question in Illinois. Do you see equally divided between the--
Allen County is unusual because, for those people who aren't
there, we have rural, suburban, and urban, an urban center of
200,000, and about 130,000 in the county, but we also have
large Amish populations. So it is rural and urban. What
percentage roughly is in the urban versus the rural? Have you
been able to--could you give some kind of just rough
breakdown--not precise--of when you have gone out to
investigate, does it seem to be things that are in the
immediate surroundings of the home or broader? Just a little
bit of an insight into the mix of what you are finding at the
grassroots level.
Dr. McMahan. Well, what we have found in Allen County is
that this is predominantly an urban problem. When a human case
is identified, that triggers an environmental investigation,
and halfway through our outbreak, we had evaluated 23 human
cases. Sixty-five percent of those properties in those 1-mile
target areas surrounding the human case we were able to find
multiple mosquito breeding sites, things like old tires,
aquariums, containers, all sorts of containers that were
breeding Culex mosquitoes.
So I think that really points to why it is so important for
our medical community to do the surveillance, because it does
assist us in identifying other areas for which other humans
would be at risk surrounding those human cases that have been
identified.
Mr. Souder. Have you seen similar patterns with the bird
population?
Dr. McMahan. The birds, I think, have been identified
throughout Allen County. I think, unfortunately, we stopped our
bird surveillance fairly early in the season once it was
established that the West Nile virus was entrenched in Allen
County, and our mosquito population surveillance was also
turning positive. But we continue to hear from the farmers that
they are just finding tremendous amounts of dead birds on their
property.
It has also been a problem for our horses. We have had 45
horse deaths in Allen County due to the West Nile virus.
Although, as you mentioned, a significant portion of our
farmers are Amish, and unfortunately they didn't take advantage
of the vaccine that was available. But there have been 350
horse deaths in the State of Indiana.
So it has been a significant problem. The virus is well
established and entrenched in Indiana.
Mr. Souder. Well, is there--I discussed this earlier. But
if you find a dead bird on your yard, it doesn't necessarily
mean you are extra vulnerable? Or does it mean you are extra
vulnerable? We talked earlier. If it is an owl or a red-tail
hawk, that might be more unusual. Does that--do you see a
direct correlation at all in the imminence of the immediate
threat?
Dr. McMahan. Well, I think the Cornell model that is used
to identify risk predicts that if you find 1.5 birds with West
Nile virus within a square mile, that area has a high risk for
human transmission. And that was the model that we have used
for our--one of the criteria that we have used for our
adulticiding program.
But I think it is important to note that the reason that
the larger birds are always selected by at least our State
department of health for identification is that they have more
brain tissue. But sparrows, chickens, all sorts of birds have
been identified with West Nile virus. So I think if you find a
dead bird on your property, I think it is important to make
sure that you dispose of it properly and with care so as to
minimize your own risk.
Mr. Souder. Are you suggesting it can be transferred by
handling a dead bird?
Dr. McMahan. I think we need to be very careful, and I
think this year, with over 2,500 cases thus far, we are going
to have--at the end of the year when we evaluate this
epidemiological data, I think we are going to have such a much
better understanding of this virus and all the potential rounds
of transmission, more so than we had based on the 161 cases in
the previous 3 years. So I would urge people to take all
precautions that they can.
Mr. Souder. Not because there is any particular evidence,
but just to be cautious.
Dr. Lumpkin, would you comment on some of the responses in
Illinois, what some of the patterns you have seen, particularly
in Cook County? We have huge cases, but I assume if you are in
every county, you have got rural cases and urban cases.
Mr. Lumpkin. We do. We are seeing cases in--human cases
throughout the State. There are 35 counties; out of 102 that
have had human cases. And we have seen deaths throughout the
State. The largest concentration, though, of cases are in Cook
County, and of those cases the largest concentration are in two
areas, one in essentially Representative Schakowsky's district
and the other in the southwest side of the suburbs in the area
directly adjacent to the city. These are again two areas that
we saw high concentrations of St. Louis encephalitis in 1975.
The pattern of human cases exactly follows the pattern of
bird cases that we saw earlier on in the summer, where you can
just see an explosive progression beginning in July, starting
in the Chicago metropolitan area and then fanning out across
the State, so it really has been quite an extensive experience.
But one of the key questions we are asking is why those two
areas? And we have asked the CDC and we are looking to do
studies over the winter to see if there are any things that
place those communities particularly at risk. At first blush,
there is no evidence. There is no evidence of increased amounts
of vegetation. The two areas do have a higher rate of people
who are over the age of 50, but why that would necessarily mean
that there would be more transmission from mosquitoes we are
not really certain at this time.
Mr. Souder. Do you know why there wouldn't have been a
focus, given the correlation of St. Louis, if that would have
been an immediate focus of the Federal Government to look at?
Mr. Lumpkin. I am not sure how many people in the Federal
Government are still in their positions who were around in
1975. We were obviously very aware of that in Illinois because
of our continued ongoing commitment to do surveillance of
mosquitoes and birds. So I think--that would be my only
explanation.
Mr. Souder. Could--Mr. Cummings, let me finish up this line
of questioning.
Did we have--I should know, but I don't. Did we have any
St. Louis encephalitis in Allen County in any extraordinary
amounts?
Dr. McMahan. In 1975, probably at the same time that you
had your outbreak, we had an extensive outbreak in Indiana. We
had 27 cases of St. Louis encephalitis in Allen County at that
time. That was actually when we started our vector control
division, after that outbreak. That was when the vector control
division actually was initiated.
Mr. Souder. Was that a complete shock?
Dr. McMahan. Pardon me?
Mr. Souder. It is not a complete shock of the patterns of
places, given the previous patterns. It is interesting--it
would be interesting if the Federal Government's taken--have we
had much Federal Government money come into Allen County? We
have a huge supplemental boost nearly of 40 percent of the
Federal expenditures. Did any of that get in as the problem
became greater in Allen County?
Ms. McMahan. We've received $1,000 directly from the State
for mosquito control.
Mr. Souder. And what about in Illinois?
Dr. Lumpkin. In Illinois I think the total funding, as
someone mentioned before, was about $1.6 million. We made
available, as I also said, about $3\1/2\ million that we pulled
out of another fund to accelerate the payments.
Mr. Souder. As the problem developed later in summer, did
you receive any boost-up in the supplemental?
Dr. Lumpkin. We received for the entire State in August--we
received a total of about $400,000--an additional 350,000 in
September.
Mr. Souder. Thank you. Mr. Cummings.
Mr. Cummings. Dr. Lumpkin, do you know what your request
was?
Dr. Lumpkin. The way the funding was allocated to us, we
were told what we could apply for, so we basically applied for
about 100,000 more than they said we could, and we were funded
for all that we asked for.
Mr. Cummings. And what did you use those funds for?
Dr. Lumpkin. Well, those funds were restricted. We were
particularly told that they were not for mosquito abatement. So
we used those to enhance some of our activities in our
laboratory. We also used them to develop a PSA that we then put
out for the media, as well as other surveillance activities.
Mr. Cummings. Dr. McMahan, the--I take it that this is--I
guess this has kind of strained your Agency a bit, huh?
Ms. McMahan. Oh, definitely. As I mentioned in my report,
over $280,000 was necessary over and above the normal moneys
that are spent on vector control. And that doesn't account for
all of the time that myself, the administrator, we've had one
public health nurse that's been devoted exclusively over--for
the past 3 months investigating cases, the environmental
investigators that need to go out and, you know, investigate
the cases to identify sources. It's been a tremendous strain,
yes.
Mr. Cummings. So how do you make up for that. In other
words, are you sort of deficit spending or what? I mean----
Ms. McMahan. Well, we've been very fortunate. First of all,
we've worked long hours. But we've been very fortunate that our
county council has appropriated the moneys that we have needed.
They have been very responsive to our need and have
appropriated the funds when requested.
Mr. Cummings. What would you like to see the Federal
Government do to be of assistance? And are you satisfied--and
this is to you to Dr. Lumpkin--with the CDC and what they've
been doing and the other agencies?
Ms. McMahan. Well I think there's been a lot of educational
support from the Centers for Disease Control. Their Web site
has been very helpful. They have sent updates with respect to
issues like blood transfusions and organ transplant issues. I
think what we need is more support at the local level. I think
the need is so great at every level for funding that our State
is in desperate need of funds; that when money is allocated at
the State level, very little can trickle down to the local
level. Not because of greed but because of need.
And so it would be nice if there were a way that local
departments of health would be able to apply for resources to
actually provide treatment, the intervention, the adulticiding,
the larvaciding, and all of those sorts of things. Those are
expensive, and as it is right now, we've received $1,000 for
surveillance this year. So our county has for--you know, over
$280,000. So I would like to see more funds given at the local
level.
Dr. Lumpkin. I think that there are a number of things that
we would--where we could appreciate assistance. First of all, I
think that given the experience that we had last year, we need
to look at addressing next year differently. West Nile is here.
It's here with a vengeance. And we would be looking for
assistance from the Centers for Disease Control in developing a
public information campaign that I think needs to be national
in scope reflecting West Nile.
People need to know that they place themselves, their
families, and their neighborhoods at risk by having containers
that hold water that will breed mosquitoes. People need to
understand the importance of wearing long sleeves and long
pants when they go out at dawn, dusk, and early evening. That
message needs to be repeated and repeated frequently. And it
needs to be done in a way that--where people are--can address
it.
To tell you the truth, doing public service announcements
that are put on at 4 o'clock at night, 4 o'clock in the
morning, or, you know, odd hours, is not going to do much to
help people learn what they need to do about West Nile. You
need to spend money to get that message out.
There are some other concrete things that we need
assistance in. Obviously we're going to run into trouble in
April in our local health departments, and funds available for
emergency funds for mosquito abatement I think is important. In
addition, I think that there needs to be a national fund for
public health emergencies. We've seen them come. We need to be
able to respond, and respond quickly, without exhausting local
and State resources.
Our State is facing anywhere from a $1 to $2 billion
deficit in our budget coming up, as many States are. And our
ability to respond to these kind of things are certainly
restricted.
The USEPA needs to look at the issue of municipal pesticide
application, particularly in dealing with mosquito abatement
control. Using larvicides, there needs to be special licenses
that are available so that we can actually get these treatments
out without expending large sums of money or hiring private
companies.
There are limited things that can be trained, particularly
with larviciding. In Illinois, for instance, we established the
1-hour course and the special licensing for people who just do
larviciding in the catch basins throughout the city of Chicago
and other places.
Resources and research are crucial. We need to better
understand as far as how it impacts, how it grows, what's
involved with the bird population, to what extent are we going
to see resistance in the bird population that would prevent the
spread of the disease. So there a number of things that I think
are on the agenda for Federal action.
Mr. Cummings. I thank you.
Mr. Souder. I'd like to ask, Dr. Akhter, you noted in your
testimony that the West Nile is spreading in different ways and
taking on different forms. Should we be concerned that like
other viruses this may mutate and become more harmful, and do
you have any evidence of that?
Mr. Akhter. Mr. Chairman, we don't have any evidence at the
moment. But I think this is the kind of thing we need to look
at other viruses of similar type: how have they behaved in the
past and what they might do, and that's why the need for a
think-tank. We just don't need to have the firm evidence here.
We need to have accurate projections, some reasonable
projection on the basis of which we would take evasive actions
to make sure that it would not do the damages that it would do
otherwise.
Mr. Souder. Well, I want to thank each of you for your
testimony that Dr. Akhter was--it has been very challenging
when we look at the international changes which are going to
accelerate in the growing diversity of the communities all over
the country and the trade and the items that we bring in that--
how we address that between our universities and the research,
and possibly tapping in, as you said, into retired experts and
others; because it's clear we're weaker on the predictability,
and even when there are patterns. But if you're doing hand-held
calculators and trying to react out of low budgets, it's very
difficult to do predictive behavior. If you're drowning in
alligators, it's hard to predict where the next thing's coming.
I also appreciate, Mr. Wichterman, your specific comments
on--it's interesting to look at where there are at least
somewhat success stories and then say, well, we might not even
be able to execute those if we are not paying attention. And
how to make sure that you have product available to do what the
mosquito control districts do, that's another whole challenge.
And it's been very informative at the local level, both
statewide, and I know the Indiana Board of Health has been very
active, too, and I'm sure in Cook County specifically.
But it's been a good mix of a panel, and if you think of
additional thoughts or if you want to approach anybody else in
your States or organizations to give additional testimony in
this record, clearly my guess is that there will be,
particularly in the midwest as we get into the fall season, it
won't be as high on the agenda.
Congress is going to adjourn. This will probably restart up
again the next session of Congress, and we need to look at it
as we move through that budget process and in the authorizing.
This is an oversight committee our goal is to identify where
some of the holes were and try to see what might move into the
legislative process. So I thank you for being part of our
hearing. I encourage you to stay involved. Thank you for your
work at the grassroots level. With that, the hearing stands
adjourned.
[Whereupon, at 4:30 p.m., the subcommittee was adjourned.]
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