TYPE: COMMITTEE HEARING

LENGTH: 26161 words

COMMITTEE: RESTRUCTURING AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE, SENATE GOVERNMENTAL AFFAIRS COMMITTEE

SUBCOMMITTEE: OVERSIGHT OF GOVERNMENT MANAGEMENT

HEADLINE: U.S. SENATOR RICHARD DURBIN (D-IL) HOLDS JOINT HEARING WITH SENATE HEALTH, EDUCATION, LABOR AND PENSIONS COMMITTEE ON WEST NILE VIRUS

SPEAKER:
U.S. SENATOR RICHARD DURBIN (D-IL), CHAIRMAN

LOCATION: WASHINGTON, D.C.

WITNESSES:

(PANEL I), JESSE L. GOODMAN, DVM, PHD, DEPUTY DIRECTOR, CENTER FOR BIOLOGICS, EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION
ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, U.S. NATIONAL INSTITUTE OF HEALTH
JULIE GERBERDING, M.D., MPH, DIRECTOR, U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
(PANEL II), FAY BOOZMAN, MD, MPH, DIRECTOR, ARKANSAS DEPARTMENT OF HEALTH, SIDNEY A. HOUFF, M.D., PHD, PRESIDENT AND CHAIRMAN, DEPARTMENT OF NEUROLOGY, LOYOLA UNIVERSITY
JOHN R. LUMPKIN, M.D., DIRECTOR, ILLINOIS DEPARTMENT OF PUBLIC HEALTH
NICKIE MONICA, PARISH PRESIDENT, ST. JOHN THE BAPTIST PARISH

BODY:

 
U.S. SENATE GOVERNMENTAL AFFAIRS COMMITTEE: SUBCOMMITTEE ON
OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING AND
THE DISTRICT OF COLUMBIA SUBCOMMITTEE
AND U.S. SENATE HEALTH, EDUCATION, LABOR AND PENSIONS
COMMITTEE HOLD A JOINT HEARING ON THE WEST NILE VIRUS
 
SEPTEMBER 24, 2002
 
SPEAKERS:
U.S. SENATOR RICHARD DURBIN (D-IL)
CHAIRMAN
U.S. SENATOR DANIEL AKAKA (D-HI)
U.S. SENATOR ROBERT TORRICELLI (D-NJ)
U.S. SENATOR THOMAS CARPER (D-DE)
U.S. SENATOR JEAN CARNAHAN (D-MO)

U.S. SENATOR GEORGE VOINOVICH (R-OH)
RANKING MEMBER
U.S. SENATOR TED STEVENS (R-AK)
U.S. SENATOR THAD COCHRAN (R-MS)
U.S. SENATOR PETER FITZGERALD (R-IL)
 
U.S. SENATE HEALTH, EDUCATION, LABOR AND PENSIONS COMMITTEE

SPEAKERS:
U.S. SENATOR EDWARD M. KENNEDY (D-MA)
CHAIRMAN
U.S. SENATOR CHRISTOPHER J. DODD (D-CT)
U.S. SENATOR TOM HARKIN (D-IA)
U.S. SENATOR BARBARA A. MIKULSKI (D-MD)
U.S. SENATOR JAMES JEFFORDS (I-VT)
U.S. SENATOR JEFF BINGAMAN (D-NM)
U.S. SENATOR PAUL DAVID WELLSTONE (D-MN)
U.S. SENATOR PATTY MURRAY (D-WA)
U.S. SENATOR JACK REED (D-RI)
U.S. SENATOR JOHN EDWARDS (D-NC)
U.S. SENATOR HILLARY RODHAM CLINTON (D-NY)
 
U.S. SENATOR JUDD GREGG (R-NH)
RANKING MEMBER
U.S. SENATOR WILLIAM FRIST (R-TN)
U.S. SENATOR MIKE ENZI (R-WY)
U.S. SENATOR TIM HUTCHINSON (R-AR)
U.S. SENATOR JOHN WARNER (R-VA)
U.S. SENATOR CHRISTOPHER BOND (R-MO)
U.S. SENATOR PAT ROBERTS (R-KS)
U.S. SENATOR SUSAN COLLINS (R-ME)
U.S. SENATOR JEFF SESSIONS (R-AL)
U.S. SENATOR MIKE DEWINE (R-OH)
 


*


DURBIN: Good morning, ladies and gentlemen.

This is a joint hearing between our two subcommittees; the Government Affairs Committee, which tries to help coordinate the agencies of government, and, of course, Senator Kennedy is chairman of the Committee on Health, Education and Labor. It is a joint hearing on responding to the public health threat of the West Nile Virus.

What we have learned this summer is that mosquitoes can do more than ruin a backyard barbecue. For some Americans, particularly the elderly and medically vulnerable, that harmless mosquito bite can turn out to be life-threatening. The numbers of American victims of West Nile Virus have not reached a level to rival major public health threats like influenza or measles, but the trend-line is not encouraging.

Last year there were 66 infections across America and 9 deaths from West Nile Virus, as they were reported. This year 1,963 infections have been reported. The death toll has reached 94. This morning two more deaths were reported in my home state of Illinois, which has reached a total of 27, and for inexplicable reasons leads the nation. In one year the infection rate is up almost 2,000 percent from West Nile Virus and fatalities over 1,000.

The source of the virus could be in backyards and parks across America despite the best efforts of the public health community. Particularly worrisome are the latest reports from federal agencies that the virus can survive in the bloodstream and is likely then transmitted by organ donation and blood transfusions.

Today's hearing is the first in the Senate since the West Nile Virus truly became a national challenge. We will ask the experts and public health from Washington and across the nation to give us an honest and accurate appraisal of this public health threat. We will ask the experts who monitor our nations blood supply what more we can do to guarantee its safety. We will learn the steps that are being taken to develop a vaccine to protect us. And most importantly, we'll call on public health leaders from every level to develop a national strategy to reverse the trend of West Nile infection and mortality.

We had hoped for a break in the battle against West Nile as the mosquito season winds down in most places across America. But the threats to our blood supply tell us this dangerous legacy may -- and I underline may -- now threaten us year round. The experts will tell us exactly what the threat may be.

We owe it to the families across our nation to re-double our efforts to protect our nation's blood supply and to prepare for the battle which awaits us again next year. Our two panels of witnesses will spell out the challenge and share with us their views on meeting it.

I would now like to turn to my colleague, Senator Kennedy, and ask him for his opening statement.

KENNEDY: Thank you, Senator Durbin. I want to thank you very much for having this joint committee with us.

Senator Durbin has been a real leader on this issue which is of such enormous concern to families across this country, and we welcome the chance to join with you on today in helping us all not only in the Congress, but the America people better understand the nature of the challenge that we're facing, as well as the kind of response that we're having and what more we can do to provide help and assistance to families across this country. And also to anticipate future kinds of challenges that are similar, as well, whether it's going to be in the food supply where we're importing a great deal more or other areas, as well. So this hearing is very important.

I know Senator Durbin feels strongly and joined with Senator Dodd that this is not just a hearing, it's the beginning of a very, very careful oversight working with the administration where we can trying to point out areas in which we need to make further progress.

So we also, as I understand, we'll be joined by Senator Breaux and Senator Landrieu of Louisiana, the states that have been particularly hard hit by the grim disease.

The goal of our hearing is to determine whether all necessary steps are being taken by federal, state and local governments to assist communities afflicted by the West Nile Fever, and millions of Americans have now become aware that the West Nile Virus can cause sickness and death. Recent reports show that the disease can cause symptoms similar to those of polio, it can imperil the safety of the blood supply -- that's an enormously important issue. We want to hear from our leaders to better understand and to guide us on the policies. We have important questions about the blood supply and its safety. We want to hear from our witnesses on this issue.

In a few short weeks, the virus has spread from the Atlantic to the Pacific, from border to border. Congress should do all it can to protect the American people from this emerging health threat. We should provide the adequate funding for public health measures to contain and reduce the spread of the disease. We should expedite the development of vaccine through new investment in research.

Threats to our nation come in many forms in the war against disease. The battlegrounds will be our nation's emergency rooms and the heroes will be our nation's health care professionals. To win this war we need to restore the funding for hospitals, invest in the training of doctors and nurses and to rebuild our public health capacity. The price of victory may be high, but the cost of defeat is higher still.

The newspapers, even yesterday, were pointing out the great amount of pressure that's on our hospitals and about the crowding -- the front page of the Washington Post yesterday. We're talking about the crowding in the hospitals, crowding in the emergency rooms, crowding in the operating rooms, and we have the stories in our national newspapers now where we're having further proposals by the administration of cuts in the support of our health care systems. The hospitals are the first line of defense; the public health system, in order to detect it and in the hospitals to contain it. And we know about the serious cutbacks that the administration's involved in now.

So we have all got an important responsibility if we're talking about trying to deal with this to make sure that we're going to give the support to the hospitals and to the professional personnel that are so necessary to deal with this issue.

In the bioterrorism legislation enacted into law earlier this year, we've begun to make some of the investments necessary to protect against deadly diseases. These investments are needed more than ever to prevent the spread of West Nile Fever. In fact, our public health infrastructure had deteriorated so significantly that the initial diagnosis of the disease was needlessly delayed. We're going to need the strong public health system if we're going to meet our responsibilities to the nation's people on the whole issue on bioterrorism, as well as the kind of challenge that we're facing with West Nile.

Unfortunately, the administration's budget steps back when it comes to protecting the public health. While purporting to provide more funding to hospitals to strengthen public health and combat bioterrorism, the president's budget actually cuts funding to America's hospitals. We cannot afford to keep Americans well and protect the public health if the administration will not do its part. We've already seen what can be accomplished through resolute action to meet a public health challenge.

KENNEDY: Within the last year's funds and leadership provided by Congress, working in partnership with the administration, produced an effective, national response to smallpox. And I'm proud that a Massachusetts company is leading the way in producing a new and safer vaccine for the dread disease. We should show the same resolve in responding to the threat of West Nile.

A few years ago, few Americans other than the specialists in exotic diseases had even heard of West Nile Fever. Today it's a disease familiar to households across the nation. The virus first detected in New York in 1999. In the next two years, the disease caused 18 deaths, 131 illnesses. This year alone over 1,900 people across the United States have become ill and 94 have died. In just the last month, the number of cases has nearly doubled. A senior citizen in South Boston and a senior citizen in Weymouth have died. This month Massachusetts identified its first child case of West Nile; something the state had never, never seen before.

We need to determine whether the steps now being taken by the Centers for Disease Control are adequate to hold the spread of this disease and minimizes the severity of the illness it causes. Basic public health precautions, such as using insect repellents, eliminating standing water near homes can reduce infections. CDC is working with local communities to provide public health information about proper precautions, but infection rates continue to rise. Clearly, we must do more.

We also need to determine whether the FDA and the other public health agencies are taking proper steps to protect the safety of the blood supply in transplanted organs, and where the NIH is developing the new vaccines, therapies and diagnostic tests as rapidly as possible to prevent infection to protect the health of those affected by West Nile. As significant as the threat of West Nile Fever itself is today, it may also be a sign of even more deadly outbreaks in the years to come.

In this era of global jet travel, it's possible to have breakfast in a country half a world away and arrive in the United States for dinner. We also import millions of tons of food from around the world. Whether released deliberately by a terrorist like the lethal anthrax attacks of last year -- I draw a distinction -- whether we're facing the possibility of a terrorist or the kind of lethal anthrax attacks of last year or brought to our country accidentally, deadly infections will threaten our health security for many years to come.

Our hearing today will consider how we're responding to the West Nile Fever today and also how we'll respond of the deadly diseases' outbreak in the years to come. I thank Senator Durbin for co-chairing this joint hearing. Look forward to the witnesses.

I especially want to welcome Julie Gerberding, this will be her first appearance in the Senate -- assuming her new responsibilities with a long and distinguished career. So we very much welcome her, as well as the other witnesses.

I thank the chair.

DURBIN: Thank you, Senator Kennedy.

Senator Gregg?

GREGG: Thank you, Senator Durbin and Senator Kennedy for holding this hearing on the West Nile Virus issue, which is an issue that is of immediate and significant importance to many of us, especially on the East Coast and as it moves towards the West Coast.

We have had, as Senator Kennedy has mentioned, a large expansion of this virus. We are now seeing in my state -- Senator Kennedy mentioned the unfortunate deaths in Massachusetts -- we're seeing in my state the death of the bird population, which is clearly tied to West Nile Virus infection, and the fact that that could be transmitted to humans in northern New England. It has already obviously caused, I believe, close to 94 deaths in our country, and there's been over 1,700 cases of West Nile, human cases, in our country. And so, we need to address the issue.

Some of the concerns have been outlined by Senator Kennedy. I think my concerns go to a couple of other areas.

First, I'm interested in knowing the origins of the disease. I'd like to know that for a very obvious reason, that if we know the origin of a disease, maybe we can stop other diseases of the same type of potency from coming into the country and if we have a sense of what the origin of the disease is.

Secondly, I'm interested in knowing what the effect of spraying is on the mosquito population, whether the benefits of spraying are outweighed by the negative impacts of spraying. Obviously, we've known for years that certain types of spraying do have a significant environmental impact. Is it appropriate for us, however, to initiate aggressive spraying programs in the face of those environmental impacts because the human impact of not doing the spraying is more significant? And even though you're not from the environmental community, I'd be interested in hearing your comments on that.

And thirdly, and probably of most significant, is the issue of our blood supply and how we maintain the integrity of our blood supply in light of the virus which appears to be a potential threat to that blood supply.

These are big issues. They're big issues for us from a public policy standpoint and obviously from a public health standpoint. I certainly appreciate the chairman holding these hearings and bringing forward these excellent witnesses so that we can get some information out to the public on this question.

Thank you.

DURBIN: Thank you, Senator Gregg.

Senator Dodd?

DODD: Very, very briefly, Mr. Chairman. I think you've covered the ground, and Senator Kennedy and Senator Gregg have raised some very appropriate questions. I'm anxious to hear from our witnesses.

As Senator Gregg has pointed out, even Senator Kennedy has, I guess, those of us from the East Coast feel this more poignantly because it's been around now since 1999 for all of us, although, obviously, it's moving across the country, and indications are on the West Coast that there are some cases that have sprung up. So we're very interested in getting an answer to this.

DODD: There is nothing more intimidating or frightening to people to have something apparently almost as innocent as a mosquito, although history has shown how lack of innocence a mosquito can have, but certainly in recent times, relative to innocence, can bring such hardship. And so, I'm very interesting in hearing what our witnesses have to say.

I think it's important at the hearing here we also commend, however, the Center for Disease Control, NIH, the FDA, as well. They've been working pretty hard on this at state and locals. We've received $200,000 in Connecticut already in this area. We've lost not any human life lost; we've had a number of cases identified in our state. So it's a growing concern.

This is a very important hearing, and I commend both the chairs for bringing two committees together. This is a wonderful example of how committees can work together with a somewhat overlapping jurisdiction to try and address an issue like this.

I also want to underscore the point Senator Kennedy made here, it's one that needs to be made, and that is while the answer here is just isn't writing a check, the obvious does take an investment of resources. That $200,000 that my state received from the federal government has been awfully important to my state, particularly in times when we're facing huge budget deficits.

And so, with people out there -- when we talk about Homeland Security, obviously we narrow that definition to some degree. But certainly, if you ask the average citizen in our country whether or not they think this an issue that deserves an aggressive action on the part of local, state and federal government, I think the answer would be a resounding yes before this gets totally out of control and we find ourselves in a far more difficult situation.

So I wanted to underscore that point that as we look at these issues and our budgets, obviously this is an important one. It certainly is in our state. I picked up the morning paper here in Washington, D.C. this morning, it asked the people of Virginia whether or not they think this is an important matter, having another life lost. So I thank you and I look forward to the testimony.

DURBIN: Thanks, Senator Dodd.

And I learned this morning two more cases of death in Illinois; one in Peoria and one in Chicago. And again, there's a mention that the outset, for some reason, our state is leading the nation in this. And as you mentioned, it started on the East coast. It has now been found -- infection has been found in 41 states and the District of Columbia. So it is truly a national challenge.

Let me welcome the first panel here.

Dr. Julie Gerberding, thank you, the new director of the Center for Disease Control and Prevention; the federal agency charged with coordinating our national response to the West Nile Virus.

Dr. Anthony Fauci, truly a leader in public health and well recognized and respected, director of the National Institute of Allergy and Infectious Diseases at the National Institute of Health. He's going to discuss the ongoing biomedical research related to the West Nile Virus.

And Dr. Jesse Goodman, who is the deputy director of the Food and Drug Administration. Center for Biologics Evaluation Research is focusing on the threat of the West Nile Virus to the safety of our blood supply.

Thank you for joining us. It is customary in our subcommittee to swear in all witnesses, and I'd ask you to please stand.

Do you solemnly swear that the testimony you're about to give is the truth, the whole truth and nothing but the truth, so help you God?

WITNESSES: We do.

DURBIN: Thank you.

The record will indicate that the witnesses have answered in the affirmative.

I would ask you each to give us, if you can, in five minutes a summary of this challenge as you see it. We may have colleagues coming in from time to time. We are facing a 10:30 vote or so, so we're trying to get the first panel's testimony in before that. And we'd appreciate any help you can give us in reaching that goal.

Dr. Gerberding, please commence.

GERBERDING: Good morning, and thank you. Thank you, Mr. Chairman. Thank you Chairman Kennedy, Senator Dodd, and Senator Gregg and all of the members of the committee.

It's a great privilege for me to be here in my first appearance before Congress as the director of the CDC and the administrator ATSDR. I really first want to thank you for the support you've given CDC and ATSDR in our work in public health over the past many years, both here in the United States, but also internationally.

We are 600 miles away from Washington, but not out of sight, and we would certainly welcome you visiting CDC in Atlanta, and we would, of course, like to visit you in your own states as well, but really would like to show you the progress that we've made toward the first steps at least in rebuilding the public health infrastructure in large part because of the support this committee has given us. I think we can convince you that we're accountable for those investments and really have made some important progress.

Today's topic is, of course, West Nile, which really is a prime example of an emerging infectious disease. And so, all of the infrastructure and all of the components of public health really have to come to bear to help us identify and respond to this new emerging infectious problem in the United States. I mean, it's also an excellent example of how the investments that we've made in the bioterrorism infrastructure have assisted us in responding to other public health threats as well. And I'll get back to that in a moment.

As of this morning, there were 1,965 human cases of West Nile Virus reported from 32 states and Washington, D.C. At least 94 of these patients have died. Our concern for the human toll of this disease is enormous. Clearly, it's not a problem just for the people who have been diagnosed with the more severe forms of the illness, but for every case of the severe encephalitis there are 150 additional people who've been infected, and about 20 percent of those have milder symptoms of the disease, thus having an enormous impact on all of us.

And I'll just say, I have had personal experience with this in my own backyard. My husband acquired West Nile infection, fortunately a mild case, but we experienced firsthand how alarming and how disturbing this illness can really be.

GERBERDING: This is a mosquito-borne disease. It was first diagnosed in Uganda in 1937. And since that time, it's been the cause of numerous outbreaks in the Middle East and Eastern Europe. Over the last 10 years, those outbreaks have been conspicuous in Russia, Romania and Israel. And the new finding in the last decade has been the association of those infections with the severe neurologic disease.

The infection arrived in the United States in New York City in 1999, and you can see here in the blue the areas of the country that were involved with West Nile during 1999. In green, the spread in the year 2000, up and down the East Coast. In the pink, 2001, spread north, and then further into the central parts of the United States. And finally, this year, in yellow, the further extension to the west and to the south.

I should also mention that we have cases in Canada, we're conducting surveillance in Mexico and are suspicious that we've got cases in Mexico. And as the mosquito vectors and the infected birds migrate north and south, we can only expect this pattern of progression to continue, and we would anticipate a further extension next year into the West Coast.

The life cycle of this virus really moves between birds and mosquitoes. So the mosquitoes move the infection from one bird to another, and over the course of the summer, there's an acceleration of the concentration of the virus in the infected birds, so the mosquitoes become much more efficient at transmitting it.

And on this graphic you can see on the top the counties in the United States that have had human cases, including one human case in Los Angeles County; but in the middle, the counties that are reporting infections in birds, and finally; on the bottom, the counties that are reporting infections in horses. You see it's a tremendous burden of infection across the United States, concentrating this year predominantly in the South -- Louisiana, Mississippi, Alabama and Arkansas -- and then in the Midwest, particularly in Illinois, Michigan, Ohio and the other central states.

Where is this virus going to go? It's too soon to tell. But we know that it's following the pattern of birds, and we can predict where the next human cases are going to be by doing the surveillance in the bird and animal population because they do accurately predict where the next wave will be and certainly are the information we need to target our integrated vector-control program.

So, in other words, when we see that the virus is active or there are dead birds in a particular area, then we can go in there and CDC will provide the technical support to that jurisdiction to initiate the appropriate steps to control the vector and also accelerate the information campaigns with clinicians and the public health system and the people to ensure that the individual protective measures are being taken.

And those protection measures include eliminating to the extent possible standing water where mosquitoes breed. That's a very, very important component of this. But, in addition, the advice to individuals to wear insect repellent that contains DEET when they do go outside, particularly in the evenings and the mornings when the most common mosquitoes involved in this feed, but also to use proper screens on the windows and do the other kinds of things to help avoid mosquito bites.

One of the concerning aspects of this problem is that it's present in virtually all kinds of mosquitoes and all birds. So it's unlike some of the other vector-borne virus infections.

There are many prevention steps that we're taking; many more steps that need to continue. But I think we've made substantial progress. We are managing this outbreak through our emergency operation center, the same way we managed anthrax through our emergency operation center, and I think that helps us provide our coordination and communication functions, as well as the training and education of clinicians that are so vital to the detection and management of the patients.

We look forward to doing more, but I think this is a true example of the importance of a public health infrastructure and the integration with state and local partners, as well as our partners in the federal government, though HSS and Secretary Thompson's leadership, to really get this job done right. And we look forward to continuing to make progress.

Thank you.

GREGG: Mr. Chairman, could I just ask one clarifying point?

DURBIN: Sure, of course. Senator Gregg?

GREGG: You said use mosquito repellent that included DEET?

GERBERDING: Correct. DEET is a mosquito repellent that keeps mosquitoes from attacking because they can't find your scent, and it comes in different concentrations. It needs to be present on the skin or on the clothing in order to serve as an effective repellent, and it is the only mosquito repellent that we have documented evidence of efficacy for.

GREGG: There was a fair amount of discussion over the last 10 years that people shouldn't use DEET, DEET-based mosquito repellent.

GERBERDING: Well, I think the data that we have indicate that it is effective at preventing mosquito bites, and we are not aware of any toxic effects in humans. For children, we recommend that very small infants not use it, because their skin is more absorbent, and for children under the age of adolescence that it not be used in a concentration higher than 10 percent. But we have not documented adverse health effects from using this product to date.

GERBERDING: And for children under the age of adolescents, that it not be used in the concentration higher than 10 percent. But we have not documented averse health affects from using this product to date.

GREGG: Thank you.

DURBIN: Thanks, Senator Gregg.

Dr. Fauci?

FAUCI: Thank you very much, Mr. Chairman, members of the committee. It's a pleasure to be here with you this morning to talk about some of the research endeavors at the NIH with regard to West Nile virus.

I want to point out first that West Nile virus is a member of the Flavy virus family, and we have been studying for years other related viruses as you there, such as Yellow Fever, Japanese encephalitis and dengue. So our ability to hit the ground running with regard to West Nile was really based on the fact that we had a program with Flavy viruses that have gone on for years.

As you heard from Dr. Gerberding, there is a wide range of clinical manifestations with West Nile virus. Although only one out of five individuals develop a mild cerebral disease, and only 1-150 to 200 develop serious complications, there are many enigmas associated with what we call the path of physiology of this disease, questions that we at the NIH are directing our endeavors to.

Of note also, most fatal cases are in individuals greater than 50 years old. There's a very sharp dichotomy in case fatality rate and age, which is something we need to probe more closely because there are some important clues about the body's ability to handle infections in general, but particularly this infection related to age.

Now, with regard to the research agenda at NIH, it's divided into several directions, some of which we have already been quite successful in.

First of all, as I mentioned, we're studying the basic research on the virus, which gives us many clues not only in the disease itself, but also in the development of vaccines, diagnostics and therapeutics. We're studying vector biology to ask some of the questions that Dr. Gerberding alluded to this time, is why now with this virus, is virtually every mosquito able to be a vector, and what's the relationship between the vector, the intermediate host and the primary host? We also have, obviously, a very intense effort in vaccine development, antiviral screening, which I'll get into in a moment, and rapid diagnostics.

Some of the accomplishments that we have been able to develop over the last year and a half to two, one very important, and I'll get to this in a second, is the development of what we call a chimeric West Nile virus vaccine, which is going to cut off the time requirement to get to a vaccine probably by several years, and I'll explain this in a moment.

We screened over 300 drugs, and we have about 15 hits of drugs that might be promising as direct antivirals. We have a successful animal model, the golden hamster, which has allowed us to test some of the vaccine and direct challenges in an animal. The development of an animal model is critical in pursuing the pathogenesis and treatment of diseases. We are, together with private companies, as well as our sister agencies in the public health service and the Department of Health and Human Services, working on rapid diagnostics.

And finally, we are responsible for the World Reference Center for all the viruses, which is a worldwide resource so that when you have a new virus and vectors, you have a whole reference center that people can pull out and compare previous experiences.

This is the model that I was referring to. It's really quite interesting. We already have an attenuated Yellow Fever Virus, which as I mentioned on the first poster, one of the Flavy Virus family. So what we were able to do is to take the genes of the coat protein of West Nile virus and insert it into the genes of the already existing Yellow Fever vaccine to develop what we call a chimera; that is what we say is a Yellow Fever backbone, but is actually expressing the proteins of West Nile. That really does cut off several years in the process of vaccine development. The company center that Kennedy said is working on this is a campus in Massachusetts, and we're intramurally doing it also with dengue. So it's really quite promising.

The plans and the opportunities that we have, as many as we've had advances, there are as many unanswered questions. So our programs for the coming year will be directed at those. We're going to try and develop new products through expanded discovery. Importantly, is the immunity to West Nile virus, including cross-reactivity. We found a very interesting finding in the animal model. If you infect the hamster with either Yellow Fever, Saint Louis encephalitis or dengue, and they recover from it, and then you challenge them with West Nile virus, they're protected against West Nile virus, which means the underlying immunity that you might even get from a Yellow Fever vaccination perhaps might give some degree of protection. Which again, is fortifying evidence why we're on the right track with the vaccine development.

Also the human disease cases, the consequences and age dependence, why are we now seeing anterial-borne disease similar to poliomyelitis? Why is there such a sharp age dependent discrepancy in mortality? These are all the future unanswered questions.

In addition, we're looking at immune-based therapies, interferon and alpha, hyperimmune globulin, as well as some nonimmune-based allergies. And finally, understanding the ecology of the host and the vectors.

FAUCI: So in summary, members of the committee, as Dr. Gerberding alluded to at the conclusion of her discussion, is that this is really part of the continuing spectrum of the threat of emerging and re-emerging diseases, be they naturally occurring diseases or diseases that are deliberately perpetrated on society in the form of bioterrorism. It's all part of the program of understanding the relationship between emerging diseases and their human hosts.

This falls right in the middle of it and is a cogent example of just yet another thing that we, the human species, have to face from the flu pandemic of 1918 to the AIDS epidemic where we're still in the middle of suffering from that to now a new and re-emerging disease. And we will, according to what was just said just a few moments ago, pool the resources of the Department of Health and Human Services and all the sister agencies to try and meet this challenge and hopefully protect the American public against future challenges.

Thank you very much.

DURBIN: Thank you, Doctor.

Dr. Goodman?

GOODMAN: Good morning, Mr. Chairman and members of the committee that's here.

I'm Jesse Goodman, an infectious disease physician and scientist and deputy director of the Center for Biologics, Evaluation and Research at FDA. And I thank you for providing FDA with the opportunity to speak with you here today about West Nile Virus.

As Dr. Fauci and Dr. Gerberding have said, there are, and, in fact, always will be, newly emerging infectious diseases which pose a threat to human health, and some of these will likely threaten the safety of the blood supply. West Nile Virus is the newest of these such challenges.

In this testimony I'd like to do three things. First, I'll provide a brief chronology of recent events from the perspective of blood safety. Second, I'll tell you about what the response has been so far. And finally, I'll tell you about our plans to further address the problem.

I think you'll see that we've come a very long way in just three short weeks, and I would like to mention the extraordinary cooperation between CDC and FDA and the impressive pace with which the case investigations have been conducted. I would also like to thank the involved states and the blood organizations whose response to date has really been exemplary.

Until less than a month ago, the potential threat of West Nile Virus to the blood supply was thought to be very low. Because of the dramatic increase in the spread of West Nile Virus this year, on August 17th, FDA, in consultation with CDC and NIH, issued an alert. This alert to the blood banks emphasized the importance of careful attention to screening procedures for blood donors, especially the exclusion of donors with even mild flu-like symptoms which could be early signs of West Nile Virus infection.

Then, about three weeks ago, the initial results of the investigation of a cluster of cases among the organ transplant recipients from a single organ donor led to a strong suspicion that the virus could be transmitted by organ transplantation. We know believe it's almost certain that the organs from a single donor carried the infections to four recipients. The source of the donor's infections may have been either natural from mosquitoes or from transfusions.

During our current state of heightened alerts, several cases in which West Nile Virus disease developed in the days to weeks following a blood transfusion, both in and out of the setting of organ transplantation, have now been reported and are under investigation. In each case so far the patients were from areas of known natural disease transmission. However, as you have heard, special studies of blood donated to a single patient in Mississippi who later developed West Nile Virus disease suggested that three blood donors may have unwittingly and coincidentally had West Nile Virus in their blood at the time they donated. So far, one of these donors' infections has been confirmed.

Based on these ongoing investigations, we have identified a risk to blood safety. But I must caution you that we don't know at this time how big or small that risk may be. Critical studies are now being implemented, in partnership with the other agencies, the states, the blood organizations, in different donor populations to assess the risk to the blood and organ recipients in this country.

Meanwhile, we have taken several important steps. First, we are continuing to encourage the reporting of cases of West Nile Virus that follow recent transfusion or organ transplantation. If a case is reported in a recent donor, any blood products still available are being withdrawn.

Second, FDA is working with blood banks to improve the reporting of post-donation illnesses and appropriate actions to be taken, including withdrawal of products where needed to help protect others.

Third, because of the potential for West Nile Virus transmission by donors who never even develop any symptoms of infection, FDA believes it is important to be ready and able, if and when needed, to move rapidly toward screening, testing of donor blood.

No validated test is currently available for donor screener, and such screening of large number of samples cannot be implemented overnight. However, I want to say there are some promising assays.

To jump start the process of getting to a reliable and practicable diagnostic test, last week we took the unusual and proactive step of meeting with the American Association of Blood Banks, AdvaMed, a medical diagnostics association, and other partners in the blood banking and diagnostic testing industries, along with laboratories whose current tests could be potentially adapted to meet this need. CBER will also continue, and if necessary expand its related work relevant to the development and review of potential West Nile Virus diagnostics, vaccines and treatments, such as mentioned by Dr. Fauci.

I am pleased to report that the medical diagnostics and blood banking communities are highly engaged and motivated by the potential public health that we're now facing. While the success of these efforts depends largely on their overcoming scientific and technical obstacles, some of which may be significant, our hope is that if needed, a West Nile Virus screening test for blood could become available, at least for study under investigational new drug application for the next transmission season.

At the same time we are continuing to explore a relatively new strategy for treating blood to kill microbes called pathogen inactivation. And we are working with the developers of these technologies to help carefully assess their safety and determine whether they can be important in helping deal with West Nile Virus.

In conclusion, while we believe there is sufficient evidence to say there is a risk to the blood supply from West Nile Virus, we should keep this risk in perspective. There are approximately 4.5 million people in the United States who receive blood products each year. Both blood transfusion and organ transplantation are often life-saving or life-enhancing.

While it is currently believed that the risk is low, it's important to say that our knowledge is very recent and is limited and it is changing rapidly. We believe patients should be aware that this risk exists and can discuss any concerns about their medical treatment and possible options with their physicians.

FDA, CDC, HRSA and all of our partners are monitoring the situation. We will continue to work together to better understand and deal with the risk as quickly as possible.

Meanwhile, let me also take the opportunity to remind everyone that blood donation is a key to maintaining an adequate blood supply in our country, and regardless of the findings and concerns here, blood donation remains safe.

Blood has been in short supply, and we encourage and thank all the Americans who donate blood. We've come a long way in a few short weeks. And I'm optimistic that we can and will respond to this new challenge rapidly and effectively. Success in controlling the mosquito-borne epidemic itself will be critical in determining the risk of infection in the blood supply and the need for future blood screening.

Again, I thank you for the opportunity to be here today, and welcome your questions.

DURBIN: Thank you, Dr. Goodman.

We have many questions. And as I mentioned earlier, there is a vote on at 10:30. I see that two or three of my colleagues have joined us and I'd like to ask them if they wouldn't mind giving a very brief opening statement, perhaps, two minutes or three minutes. And then we can go to the first questions.

And let me start with Senator Frist, and then Senator Landrieu and Senator Warner.

FRIST: Thank you, Mr. Chairman.

And thank all three of you for being here today and your excellent presentation.

From all three of you, you've emphasized the importance of what we refer to as dual-use of the resources that we, through government, make available to you and the private sector to provide both direct research, as well as incentives in an intramural and extramural way.

This linkage to bioterrorism and the substantial increase in the funding that has occurred since September the 11th, hopefully and based on what you've said, is a good demonstration of such dual use, in that, with your chart, Dr. Fauci, where you mention HIV-AIDS and you mention the flu, which affects so many, and you mention the West Nile Virus, you could very easily add smallpox, which is on the front page of the paper, as well, in terms of this uniform response in terms of protection and prevention and response and surveillance as we go forward.

FRIST: So over the course of the morning, I would be interested in both this panel and the next panel commenting further on that.

I do want to address an issue a little bit later in terms of are we responding quickly enough. This started in 1999. We see where we are today. Dr. Goodman, you said we have no screening test and we essentially have no treatment today. It is in our blood supply to some extent. That can strike great fear in people's hearts and minds, and it shows there's a lot to be done.

Knowing the natural history of such disease, did we respond as quickly as we should have over the last three years, from a government public accountability responsibility, since we knew West Nile was coming, we know there is a natural history to these diseases, we're seeing that play out today?

And finally, what do we expect for next month? The mosquitoes are going away now, is this thing going to disappear or is it going to come back with a bigger surge next year?

DURBIN: Thank you, Senator Frist.

Senator Landrieu, if you'd like to make an opening?

LANDRIEU: Very briefly, Mr. Chairman. Thank you for calling this hearing; it's very timely. And as you know, we've had the most cases in the chairman's state, in Illinois, but we've had 11 deaths in Louisiana and over 260 people infected. In our capital city in Louisiana, we reported three deaths and 42 people are ill. So it's a very serious situation everywhere, but particularly in Louisiana.

And, Mr. Chairman and members, I'm very pleased that one of our parish presidents is here with us, Nickie Monica, who will be on the second panel, at St. John Parish.

Louisiana has been spraying for mosquitoes since the very first person landed in Louisiana over 300 years ago, trying to get rid of these pests, and up until recently that's what it was, it was just a pest. And it's extremely aggravating and in some ways debilitating to be working in a place where mosquitoes can be serious pests and cause illnesses. But never before have we faced this kind of illness that can bring with it death. People are very concerned.

And my point would only be today that, while we focus federal help on the disease itself and the infection and the treatment, let us remember that we're on the front lines, our parish and county officials, trying to get funding for the spraying to prevent the, you know, spread by mosquitoes, and we can't, I think, lose sight of the need that our local officials have just for the eradication and the spraying and the methods that can be used to really target it or attack it in that way.

So I thank the panel. I'm looking forward to the second panel.

And thank you, Mr. Chairman, for calling this hearing today.

DURBIN: Senator Landrieu, thank you.

And, Senator Warner, I know you saw this morning's paper.

WARNER: Yes. This is our paper today. I point out, it is front page news showing the depth of the concern, as pointed out by colleague Ms. Landrieu. And I might -- when the question comes, I hope you would give us -- share us what knowledge you may have apart from the scientific. We gain the clear impression that everything can be done by the organizations, state and federal, who have jurisdiction over problems like this, but what about advice to the citizens of how they might alter their daily activities, themselves and their children, to minimize this? The obvious, of course, is at twilight, when the mosquitoes are most active, get indoors, I suppose; simple things like that would be helpful.

DURBIN: Thank you, Senator. Anything further you'd like...

WARNER: No.

DURBIN: OK. What we're going to try to do is this: I'm going to ask Senator Kennedy and Senator Gregg to ask the first round of questions, and if a vote starts I'll take off and try to make that vote and return, so that we can just keep this moving apace.

But let me open with Senator Kennedy.

KENNEDY: Thank you very much. Thank you.

Let me ask you, do you think there's any way to eradicate the West Nile, or are we stuck with this every summer from now on?

GERBERDING: The pattern of the similar viruses in this family is that they wax and wane over years, but we can never really completely eradicate them from the population, because they're just too deeply embedded between the birds and the mosquitoes.

And as we over-winter, meaning the mosquitoes in the southern part of the United States don't die off in the winter, so they may continue to transmit all year round, it's just about impossible to completely eliminate it.

KENNEDY: Well, is there anything that you can tell us about whether it's rising or declining? What can we anticipate the next year, the next summer, the summer after? What does your analysis reflect on this?

GERBERDING: In terms of this year, in the southern states the epidemic started very early and has already peaked and it's beginning to fade away. In the northern states, especially around the Great Lakes, it started much later, much more rapid increase in cases, but there, too, we're beginning to see the decline suggesting that this year's epidemic is beginning to wane off.

And, of course, as the weather gets cold up north we would expect to see a marked reduction in cases because the mosquitoes would no longer be feeding.

KENNEDY: One of the few advantages of a colder winter.

GERBERDING: Right.

KENNEDY: But in any event, what it is for next year it's difficult to anticipate, whether it's going to be more virulent next year during the spring and the summer; it's difficult to tell?

GERBERDING: It's very difficult to tell because in part it depends on the weather, and it also depends on the micro-climate. You know the West Coast is very different from the South, but it also depends on to what extent we get out there early on with integrated control programs and deal with larvacide and also the extent to which people implement their own personal protective measures.

KENNEDY: Dr. Fauci, you mentioned the development of a vaccine. How close are we to the development of a vaccine on this?

FAUCI: The Phase 1 trial, where we put it into humans and start determining safety, are going to be underway imminently. Hopefully what we will have is about a year's worth of that and then go right into Phase 2.

So I would imagine it's three or so years away, which is really light speed when you think in terms of development of a vaccine. So we will likely have one, if successful, within the next few years.

KENNEDY: What will that mean for people that -- they'll be able to take it and then have -- be immunized to the disease, is that right?

FAUCI: The same way -- since it's a flavi virus, as I pointed out, same way when you get a yellow fever vaccination, you're essentially protected from yellow fever if you go on a trip to a yellow fever-endemic area.

It might turn out, depending on the evolution of the epidemic, that we would take at-risk people, particularly people who are immuno- suppressed or people who are beyond a certain age, and they will be the first targets of a vaccine program.

KENNEDY: Dr. Goodman, you mentioned that you've been meeting with the blood banks, and those that have been involved in that industry; that they're motivated. If needed you could mandate a test but you're looking at other tests that may be helpful in terms of dealing with the pathogens, I guess, in the total blood supply.

Why shouldn't we mandate a test now? The idea, as I understand it, is if you mandate the test it builds up the interest from those that may be interested in producing a test, and it only goes into effect when they develop it but it creates the market, creates the financial incentives for those to go in there.

Given the evidence that we had in terms of the danger to the blood supply -- I heard you when you said that it may not stay in the blood supply for a very long time, but we've seen this infection expand. For the people that are going to be endangered that's not a very good, satisfactory answer. Why not go ahead and mandate the test now?

FAUCI: Well, I think it's a good question, and what we have signaled very strongly to the diagnostic industry and the blood community is that, based on this rapidly evolving evidence we're seeing, that we think it's very likely that there will be a need to be generalized testing of blood.

KENNEDY: Let me stop you there. What does it mean to people that are watching this? It looks like the development, that there may be a reason that we go in to try, and may do this in the future. I mean, these are as current as this hearing. People are out there and they're concerned. When we can go ahead and mandate this test, why don't we just go ahead and make this matter as a public policy? Why not just go ahead and do that?

FAUCI: Well, first of all, we are proceeding as if generalized testing with blood will be needed. So in that sense, I totally agree with you.

In terms of mandating...

KENNEDY: Excuse me, and I want to give you a chance to finish, the generalized test that you're looking at is in the much broader, kind of, scope to look at a variety of different things rather than just in the West...

FAUCI: Oh, no. No.

KENNEDY: ... just on the West Nile.

FAUCI: I'm talking about a specific West Nile.

KENNEDY: West Nile. All right.

FAUCI: Absolutely, sir.

KENNEDY: OK. The time is limited. What is going to be the factors that you're going to consider -- whether you're going to go ahead and mandate a test or not? And in what period of time? And how long will it take -- an estimate?

FAUCI: OK. What we are aiming for is to work with the diagnostic and blood industry to rapidly assist and facilitate transfer of existing testing technology that's currently in place at CDC, other research labs, so that it can be done on broad scale, if needed, in a very, very rapid fashion.

In terms of the issue of mandate, there are two ways that FDA can assure that needed testing of blood is done. One is through regulation -- normal comment and notice rule making which, as you know, takes time. The other is we can issue a guidance for immediate implementation, which blood banks in the community have interpreted and followed as parts of our requirements for good manufacturing practices for blood.

So that, as we continue to look at this evidence, we will issue guidance as and when is needed, and I think we are behaving as if it will be needed.

And I would also say that I am not saying -- the financial issues you raise are important ones. You know, we don't make the diagnostic tests and, in a way, the industry needs to be able to see that there is a market in order to be incentivized to do this.

What I can report is based on the meeting we had with a number of key diagnostic firms and other parties last week. They are proceeding as if they perceive that there is a market, and they are moving very rapidly to work with us and have testing available should we need it in a general way.

But I support the...

KENNEDY: My time has expired. I want to be clear: It seems to me that the evidence is sufficient that we ought to indicate a mandatory test and create the kind of climate and atmosphere where they're going to be what is necessary, and that is the financial investment to move ahead. It seems to me we have the sufficient material.

I thank the chair.

DURBIN: Thank you very much.

Senator Gregg?

GREGG: I don't want to pursue that discussion, but I have a lot of trouble mandating a test that doesn't exist. I think that the object is to get a test that does exist and then determine that you can mandate it.

KENNEDY: Well, that's what it does, Senator. It only goes into effect when they get it. You create the business climate and the incentives to do it, and that's exactly the way it is done with this kind of a problem.

GREGG: I'm wondering whether the panel would comment on whether you should have spraying for the killing of mosquitoes. And do you consider this virus to be a significant enough threat that we should rapidly pursue in various communities a policy of spraying?

GERBERDING: First of all, it's important to recognize that no pesticide is 100 percent safe. And so, we don't want to use them if we don't have to use them.

The approach to controlling mosquitoes is really best done with an overall integrated approach, which starts with, as I said before, draining the standing water where the mosquitoes breed, wherever that's possible.

In addition, using larvacide which does not involve spraying and is a much safer, much less toxic form of mosquito control, it can be done early in the year, often using organic materials that are safe for human health, is a very effective early-season strategy that can attenuate the whole mosquito epidemic curve.

Spraying is really the last resort, and the technical assistance that CDC provides usually suggests that we not institute spraying programs until there are actually human cases in an area because we try to deal with the problem through all other means first.

GREGG: Now, you mentioned -- this issue of DEET, I've got to revisit that because I know in my region of the country, where there's a tremendous amount of hiking and woods activity, that for the last few years there's been a very aggressive effort to not sell or use anti-mosquito lotions that include DEET, because there was some perception that the DEET was a problem; that it penetrated the skin and created significant potential problems. But it's the position of the medical community that DEET is not a problem unless it's with a young child.

GERBERDING: That's the information we have available, but I will go back and...

GREGG: No, that's fine. I just think we need to, sort of, clear the air of that because there's a cottage industry out there saying, "Don't buy a product that has DEET in it." And it's quite aggressive, I can assure you, especially in the hiking community in New England.

If people have had a transfusion recently, what level of concern should they have? Or if they've had some sort of major blood work, what level of concern should they have?

GOODMAN: Well, I think, again, this is an issue that has to be kept in the broader perspective. We're taking this very seriously. We are very concerned by any transfusion-transmitted infection. As I mentioned, there are several case reports which have been received by the federal agencies in which blood transfusion is raised as a possibility for disease transmission, and one of these the evidence is strong right now, we believe. So we have to take this seriously, although, again, as I mentioned, we have to take this in the context of 4.5 million people receiving blood in the United States a year.

So, while we take this risk to the blood supply very, very seriously and we're being very aggressive about it, for people for whom a blood transfusion is life-saving or an organ transplant is life-saving, the risk is likely to be much smaller than the potential benefit, and people need to keep that in perspective.

GOODMAN: But, no, in fairness, it is a rapidly evolving situation, and we want people to be aware of the potential risk.

GREGG: What do you see as the time frame that you'll have a screening test that could be generally accepted?

GOODMAN: Yes. I think it's an excellent question, and you know, I just wanted to also get back to a little bit of where Senator Kennedy's concern was coming from, that it would be very difficult for our us, through whatever regulatory process, to say, "You must perform a test that is not in fact currently available." What we're trying to do is everything we can to get it to the point where a test is available. And we really are giving that message, OK.

And what we are hearing is that, by doing several things, trying to work on technology transfer from existing tests -- it's not as if things haven't been developed which could be applied to this. But the issue is taking and existing test and potentially automating it and applying it to millions of samples.

What we are hearing from partners in industry and the blood banks is that they are hopeful that they should be able to do this in time for the next major transmission season.

As I mentioned, there are some significant obstacles, but FDA also -- we can help with this. We can allow use of these in a test situation before they are licensed to help provide additional public health protection.

So certainly from FDA's point of view, this is a high priority. We will work with these companies, we will do whatever we can to help them get it out there, but in the end, we're not completely determined...

GREGG: Well, are we talking six months to a year, two years, three years?

GOODMAN: I think, an optimistic version would be to have this available for next summer for the next major mosquito transmission season, at least for use in a study situation under investigational new drug status at FDA. If we can do it sooner that that, we would be delighted to see it used again in pilot tests. But I share your sense of urgency, if this is needed. Thank you.

GREGG: I appreciate the panel's commitment to this.

DURBIN: Thanks, Senator Gregg.

Let me ask the panel. One of the most important things that we do here is to try to put things in perspective. And I think it's very important when we talk about issues of public health, to put them in perspective. There's a tendency for us to rush to the disease de jour, and for the press and politicians to focus on that and to ask the American people, with laser-like intensity, to join us. And certainly on a daily basis, we pick up the newspaper -- Senator Warner did this morning. And I hear from my home state, and Senator Landrieu, who'll be back, hears about Louisiana constantly.

Dr. Fauci, when you put your poster up here about this challenge, you compared it to a flu pandemic and the AIDS epidemic. Put this in perspective for us, so that we can understand what the public health threat is. The numbers from year to year are astounding in terms of growth. But in terms of the threat to America, give us your best analysis -- and I'll ask the other two doctors to join you.

FAUCI: Yes, and I think it's important, the point that you brought out. Certainly quantitatively, when you look at the public health impact of the flu pandemic, which killed 25 million people, 750,000 in the United States, HIV-AIDS 23 million dead, 40 million infected, I can't imagine from knowing what we know about mosquito- borne diseases, how they spread and the generally normal cyclic nature of Flavy viruses -- if you look at what happens with St. Louis encephalitis -- it is extraordinarily unlikely that the impact of West Nile would ever even get into the same radar screen as the two other diseases that I'm talking about: flu and HIV-AIDS.

Having said that, this is a disease that we need to take seriously, because it's not trivial. It's not going to wipe out scores of millions of people, but it is an evolving disease. This is the worst year that we've ever had. Hopefully, next year we'll see a downswing, the same way in the late '70s, when we first had St. Louis encephalitis, we had a disease that had 1,000-plus cases, and then the next year it went right down.

But to say this is something trivial, I think would be far underestimating it. So, not as bad as the major public health catastrophes that we have, but something we need to keep our eye on, and be ready for the worst. That's my evaluation of this.

DURBIN: In your business, in your profession, you measure the ebb and flow of an epidemic.

FAUCI: Right.

DURBIN: And you've just given us an example. Now, are we to surmise or conclude that, based on what I think are fairly primitive responses to a mosquito-borne illness, insect repellent, fogging and spraying, that we can see a decline? Can we anticipate a decline in infections and deaths next year?

FAUCI: I think so. I think that there is certainly a possibility that, with the preparation right beforehand of mosquito- control alertness on the part of the public regarding the possibility -- doing the kinds of things that Dr. Gerberding said, that it is quite likely that we will see a decrease. There's no guarantee.

The thing that we want to do is to do the public health measures that Dr. Gerberding spoke about. The blood protective mechanisms of -- regardless of what happens, forge ahead, the way Senator Kennedy said, about getting a diagnostic test for the blood, and at the same time have a vaccine available, so that if in subsequent years, we don't see a decline, we see actually it continues to get worse and worse, then we'll have a vaccine that we can vaccinate susceptible people, we'll have a screening of the blood test, and the public health measures will be that much more experience. So that's what my assessment would be.

DURBIN: And let me ask the panel, and for anyone who'd like to respond to it now, and that is, if this is the type of virus that you have indicated, where if you have an immunity to another similar mosquito-borne illness that it works against West Nile.

FAUCI: Partially.

DURBIN: Let a liberal arts lawyer ask a doctor. Why are we not immunizing them for one of these other possible illness with a safe vaccine, knowing that it'll have a positive and prophylactic effect when it comes to the possibility of West Nile virus infection?

FAUCI: There's two reasons for that. One, because the data in humans has not verified yet the data in animals. We're doing studies looking at -- actually there's going to be studies that will be retrospectively going back of people who have actually been vaccinated for yellow fever; what is the incidence if you do antibody tests to see if they've infected with West Nile and/or gotten sick?

So, you can get scientific data, but the definitive proof that in humans it's protective, does not have enough data to allow us to then say, "Based on animal model, we're going to go ahead and vaccinate."

The next issue was, who to vaccinate. You certainly don't want to generally vaccinate the entire population, because the younger people really are at very, very little risk of serious disease, with some notable exceptions. There's very, very little risk.

DURBIN: But is this similar to the flu vaccine, where we tell elderly Americans be particularly attentive in the need for it?

FAUCI: Exactly.

DURBIN: All right, thank you.

DURBIN: Let me ask you, Dr. Gerberding, in terms of our response, we're talking about an added public health expense to a system that is already straining to keep up with all of the challenges, from sexually transmitted diseases, just immunizations for children. As Senator Kennedy said, you know, we just take it for granted that our public health system can absorb all these expenses. Now, we are putting into it another challenge. Do we need to put more money into it, as well?

GERBERDING: The investments that we made this year were $29 million in the initial appropriation and then a supplement of $18 million that primarily went to the states that were heaviest hit by the problem. That money was used to shore up surveillance and tracking of the disease in the birds and also to support the laboratories. But I think the system was stretched.

Many of the laboratories report that they are at surge capacity. We've noted some delays in reporting the infection and getting the information back to us to, sort of, track the epidemic. I think we have done the best we can with the resources that we have, but the system is very stretched.

DURBIN: Dr. Goodman, same question: Is this a situation -- the barriers are transferring the technology and new testing from the labs to the blood community; is a question of money or personnel or time, what is it?

GOODMAN: I think it is more an issue at this point of technology. But I agree with your concern and Senator Kennedy's comment that the industry has to feel that there's a potential market here and be motivated by it. So I do think that's important.

But as I said, again, the message that I'm getting, at least informally and in recent meetings we've had, is that they are rising to the challenge and taking this very seriously and will move this along as quickly as possible.

DURBIN: Last time I gave blood there must have been 60 questions asked of me, maybe more.

GOODMAN: Right.

DURBIN: Are there new questions being prepared for blood donors that really focus on West Nile?

GOODMAN: Well, we're looking at this issue and working with the blood banking community closely.

As I mentioned, the purpose of the alert back in August was the concern that -- to prevent people with even mild symptoms of West Nile from donating blood. We're also working to be sure that people who subsequently develop an illness report it so that intervention can be made.

Some people have raised the issue, should we just be questioning donors about mosquito bites. Of course, the problem there is that one would exclude hundreds or thousands of donors for everyone potentially protected.

I think we simply need to know more about how much of this is out there to know how to best intervene.

DURBIN: Thank you.

Senator Warner, we have five or six minutes on the vote. But please, if you...

WARNER: Why don't you go ahead and I'll just...

DURBIN: I'm finished at this point in this round. Please.

WARNER: Do you have to vote?

DURBIN: Pardon me?

WARNER: I was just going take just a minute to return to my opening comments about what we might at this juncture in this problem advise the public who are following, who are concerned for themselves, for their families. What steps -- obviously, you spoke about the use of repellent. But I don't want to put the wonderful American tradition of the outdoor twilight barbecue out of our culture. What advice can you give us?

And secondly, most people are conscious when they're well-bitten by a mosquito -- sometimes you might not be aware when they make a pass at you. But what is the lapse time between the bite and the onset of the first symptoms?

GERBERDING: Let me address your first question. The population that I'm the most concerned about are the elderly people who are at the highest risk for the severe form of the disease. So we have developed public service announcements and media campaigns to specifically target that population. In particular, advise them about the importance of -- if they must go outside in the evenings or the early mornings, to use the insect repellent, but also just to wear an extra layer of clothing. And I know that's hard when the temperature's hot and its humid outside, but to keep the skin covered and to, you know, do things like drain the water out of the water pots in the backyard.

Most of the mosquitoes transmitting this virus live in the suburban backyard. And so, the things you can do to eliminate their breeding ground can really help reduce the mosquito pool in the neighborhood.

WARNER: Doctor? Each of you may have a little commonsense advice.

GOODMAN (?): Exactly. Just to reiterate what Dr. Gerberding said, it really is some fundamental, simple things that you can do about warning everyone, particularly people who might be more susceptible to getting serious disease, and do some very simple things.

I mean, I go out in my own backyard -- I live in Washington, D.C., and, you know, every few days you see something there that has collected water, be it a flower pot or inner tube or whatever the children play with, and you just make sure everyday you go out and turn it over and don't leave any standing water. Because that really...

WARNER: Well, those, I think, are obvious to us.

Lapse time between your knowledge of being bitten and the likely onset of this problem.

GERBERDING: In general, the incubation period is usually just a few days, two to four days, but it can be longer. We have at least one patient with a Flavy virus infection where we know the incubation period was 17 days, but most often it's very short.

WARNER: Any variation of that opinion?

FAUCI: No, it's about right: two to 15 days.

WARNER: I thank the chair. Very good hearing.

DURBIN: Thanks, Senator Warner.

Let me ask, if I might, can we draw anything from the recent evidence or indication that this creates some times temporary polio- like symptoms? Is this a natural outgrowth of what we saw initially, what appeared to be encephalitis, or is this something new and alarming or...

FAUCI: It's new and alarming, because what we're seeing is that not only is this virus acting in an unusual way, as Dr. Gerberding pointed out, it's infecting virtually every known mosquito species. The mammalian, bird and other range is much greater. And now we're starting to see clinical manifestations that if you open up a textbook and look under West Nile virus and its manifestations, something like anterior horn cell, which is the cell that's infected to give you a polio-like syndrome, that is really rather novel for this.

So we're concerned that the range of disease manifestations might be broader than what one would have originally thought when you think in terms of West Nile.

DURBIN: Well, because our panel here has such great responsibilities and their time is very valuable, I'm going to leave to vote and turn this over to Senator Hutchinson for questions.

And ask him if another member arrives after you finish, if you would pass the baton along. And if not, we'll just stand in recess until another member does.

Senator Hutchinson?

HUTCHINSON: Thank you, Mr. Chairman.

And I apologize to the panel for having a conflict and only now arriving. I'm not sure of everything that's been asked.

But I represent the state of Arkansas, where we currently have nine human cases of infection and 18 more are pending at the CDC for verification. Arkansas has also seen an unprecedented rate of infections among birds and horses. Positive birds have been found in 48 of the 75 counties in Arkansas.

Our governor recently released $1 million in emergency funds for mosquito abatement at the local level, and this is in addition to almost $400,000 that was recently granted to the state by the Centers for Disease Control.

Now, as I understand, West Nile virus has been common in parts of Africa, the Middle East and Eastern Europe for many years. Have there been -- because of the incidents in that part of the world, have there been any documented studies of these affected regions and countries about the transmission of the virus by means of blood transfusions or organ transplants?

GOODMAN: No. There were no documentations in the many areas where this disease has been epidemic or in previous years of infection in the United States of any infection spread by transfusion or organ transplantation. And this was one of the factors which contributed to the assessment that, while this was on the radar screen, the risk was likely to be low.

HUTCHINSON: OK. In the United States have many cases have now been verified this year?

GOODMAN: Of West Nile?

HUTCHINSON: West Nile.

GERBERDING: That's 1,947.

HUTCHINSON: And the deaths have been?

GERBERDING: Ninety-four.

HUTCHINSON: Ninety-four. Is that ratio consistent with what we see where that the virus has existed for years and has been more common?

GERBERDING: In general, the mortality rate from the severe form of the infection, which is the brain or the meningitis form, is 10 percent. And that fatality rate has been the same for several years and is similar to the fatality rate observed in Europe.

The ratio is not looking that way here because our total case count includes some of the much more milder forms of the illness, the so-called West Nile fever. So we don't have the right numerator and denominator together to give you the 10 percent.

HUTCHINSON: Do they calculate the milder form at all or are they only looking in other parts of the world at the more severe?

GERBERDING: In general, it is the more severe form of the illness that gets diagnosed accurately with the blood tests. And so when we report cases, we are usually limited to the severe form, and that's where we calculate that 10 percent death rate.

HUTCHINSON: Donor screening is one of the five parts of FDA's blood safety system. If most people infected with West Nile virus either show no symptoms or flu-like symptoms for just a few days, does donor screening become ineffective, since a potential donor will not necessarily be conscious of the fact that they have the virus, that they carry the virus?

GOODMAN: Yes, that's a real concern. Donor screening, in terms of asking questions about how people are feeling, in terms of the medical exam for fever, as well as other measures we've been promoting, such as calling back if individuals develop illness and taking appropriate steps to protect blood safety, these will only deal with part of the problem if completely asymptomatic individuals can also transmit this by transfusion.

So that is why, as we're assessing the degree to which this is going on in a problem with the blood supply, we are pushing on the development and technology transfers, so that if needed there can be an actual blood test or donor screening test. Because that would be really right now the only effective means of dealing with a problem if it were a significant one in the asymptomatic donors.

HUTCHINSON: And we don't know right now how much of a problem it may be?

GOODMAN: Well, I would say we take any problem as a significant problem. And if you look the fact, as you mentioned, that people can have the virus in their blood without having symptoms, we take that seriously.

But right at this time there are -- what we have is a few case reports under intensive investigation, some of which may represent this kind of transmission. But we're behaving as if they will show that this could occur and that we need to be prepared and potentially screen the blood.

One opportunity I'd like to take, and perhaps Dr. Fauci or Dr. Gerberding would comment also, is that -- Dr. Fauci was asked earlier to put this in perspective with AIDS, which I think raises very important concerns and legitimate concerns when people hear about a disease that might be transmitted by blood, where this was such a problem for AIDS.

With West Nile virus there is a major important difference here, and that is, that the currently available science would suggest that this virus is only in the blood for short periods of time in the donor.

GOODMAN: The donor then clears the infection. That's not as if there is a reservoir of folks walking around chronically for months, years, lifetime with this in their blood. So that is an important distinction. It doesn't mean that we don't need to take this seriously.

And again, my point of view is: Yes, we need a lot more information to know the degree of the risk. But while we're getting that information, we want to respond as if this risk were serious and significant and may require testing.

HUTCHINSON: Let me just ask a, kind of, broad, open-ended question. Is there any tools or any additional authority that CDC should have in order to combat West Nile Virus?

GERBERDING: No, our work, in terms of controlling the mosquito component of the infection, is based on cooperation with the state and local health officials. So the jurisdiction for making decisions about what kind of intervention program is appropriate are at the local level.

We obviously are not a regulatory agency, but we do have, I think, very effective and supportive interactions with the public health community. And I think right now our technical support is respected. The training that we provide has been well received.

An example of that is the fact that every laboratory, every public health laboratory in the United States has been trained by CDC to do the testing of the human cases and bird cases and horse cases of West Nile. We provide the reagents. And we've been able to document this year that that training has paid off, because the labs are doing a terrific job.

So we have the capacity to get the job done right. And I don't think that our authority is the right limiting step in this. I think it's really simply the fact that this is an evolving epidemic, and we don't know where it's going to go next.

HUTCHINSON: Anybody else?

Yes, I think following up your comments, do you have any reason to suspect that different strains of the West Nile might develop? And is the fact that some victims suffer paralysis while others do not a sign that this could be a different strain?

GERBERDING: We've been working on characterizing the strains of the West Nile here in the United States since 1999, and comparing them to the strains that were involved in the outbreaks in the Middle East and Eastern Europe. And what we've found is that, so far, all of the isolates that have been characterized in the United States are extremely similar, if not identical. So it looks like there's this single strain of West Nile evolving here.

Of course the most recent isolates from these cases with polio- like illness and some of the other more unusual clinical syndromes are not fully characterized yet. So we look forward -- that's one of our major research issues, is to do that string characterization and look, kind of, at the strains from the standpoint of the illness that they create, as well as the geography where they're located.

The strains that are here now are very similar to the strains that have been causing problems in Europe over the last 10 years, but not completely identical.

HUTCHINSON: OK, thank you. My time is up.

Senator Frist?

FRIST: I apologize. We've been voting, so we may have covered some of these questions. But let me, while we have the opportunity, just go through some things real quick.

Canada, south of the border, what's happening in terms of -- the maps, kind of, stop. And then, would a spread go further south, or what would be the natural history of it?

GERBERDING: There are cases reported in Canada, not surprisingly given the bird migration patterns in the summer season there.

We have one human case documented in Cayman Brac. That's the only documented case in the Caribbean so far. But the surveillance activities are just beginning to gear up in that part of the country. And we are concerned abut places such as Cuba or other areas in the Caribbean where we may not have the information about the mosquito infection or the bird infection the same way we do here, where...

FRIST: Is the potential because a place like Cuba or Senator Landrieu mentioned Louisiana -- the further south you go, the mosquitoes are going to be more around -- that this will go down and become a real haven, and then this is going to get a lot, lot worse? Because we don't have the controls, we can't do the outreach, we can't do -- educate for the prevention. And obviously look at the history of malaria, being the third biggest killer in the world in mosquitoes, is there any -- is there a concern, and what do we do?

GERBERDING: There is a concern. I think as this virus moves out to the Americas, we're alert to the fact that other mosquito-borne diseases are extremely effectively transmitted in Central America and South America. And dengue is one of those mosquitoes which is a close cousin of West Nile.

And what Dr. Fauci mentioned earlier, the mystery is, does infection with something like dengue give you a little bit of immunity to the West Nile virus so that the population may be less at risk, or is it just another serious infection that we all had to add to the list? And it's just too soon to tell.

FRIST: Is the -- Dr. Goodman and Dr. Fauci, the one and two -- the 150 and the -- your slide that put the side affects and the low incidents of really severe infection, that's based on data from earlier outbreaks. But now that we have 900,000 people who are HIV positive, we had my own profession of heart transplant, thousands of transplants being done every year, probably about 8 or 9 million people cancer with -- either being treated or already immuno- compromised, could it be that those figures overall would be much higher, given today's population is very different than when most of that data was generated? You mentioned age, but if you could just paint that perspective for me.

FAUCI: Yes, the data of the 20 percent of people will develop mild symptoms and one to 150 to 200 are really very much in line with what we've seen from outbreaks in other countries. However, each year one can then go back, after the epidemic is essentially died down for the season, and do sero-surveillance studies, and get a feel for how many people in a given population were actually infected.

FAUCI: In fact, in New York, that very maneuver was accomplished, where they went back and looked at, when you had the original 60 cases with X-number of deaths, you go back and in that Queens area of New York City that had the major infection they found that about 2 to 3 percent of the entire population had been infected. And they were able to then extrapolate that, based on the identified clinically apparent cases to give you that ratio.

We can easily do that by going back and doing retroactive sero- surveillance studies.

FRIST: The three largest outbreaks in history are what? Did you all go through the history at all in terms of West Nile, not in the United States but before?

GERBERDING: We haven't mentioned it in detail, other than...

FRIST: I think it's worth mentioning. If you had to look at the outbreaks, just and very quickly because I've got a bunch of questions, but the first West Nile appeared when and how big an outbreak and what happened in the Middle East?

GERBERDING: The first case was documented in Uganda in 1937. I'm not clear if that was associated with an outbreak or not. I think it was incidentally diagnosed.

And then in the last 10 years the largest outbreaks have been in Rumania, western Russia and in Israel, particularly noteworthy outbreak in Israel involved patients in a nursing home where there was a very high incidence of the encephalitis and the severe meningitis.

So the largest outbreaks were clustered in that area of Europe and the Middle East.

FRIST: Any long-term sequela that appeared five years later, 10 years later or 20 years later that we know of?

GERBERDING: We have studies ongoing now to follow the natural history of infected people, but it's too soon to say what the ultimate outcome would be.

From the New York patients in 1999, many of those who survived the encephalitis remain with neurologic complications and fatigue syndromes and other serious disabilities.

FRIST: That appear later or appear as sequeli of the disease, the acute disease?

GERBERDING: Most of them had a continuum from having the illness and never regaining a full recovery.

FRIST: Dr. Goodman, organ transplantation, a single organ donor -- one of the beautiful things about organ transplantation, organ donation, is that one donor who is generous and unselfish enough to having donated organs at the time of death cab transplant a heart, a lung, another lung, a pancreas, a kidney, obviously bone, tissue, eye, cornea, and help as many as 40 different people, four-zero, one donor.

GOODMAN: Right.

FRIST: And that's the beauty, and again, plug for organ donation as we go forward.

On the other hand, based on what we know today --and people, this, really want you just to clarify what we know and I know we don't know a lot -- we have organ donation, we have blood. We're worried about our blood supply for people who need to receive blood. We don't have a good screen for it yet that's commercially available, that can really be applied.

But also from an organ donor standpoint, now that we are quite certain that the tissue that is used, if you have one donor affecting 40 people, isn't it incumbent upon really to have a crash course or screen for that donor?

And what are we recommending to the transplant community? Right now, again, most people know this, but we screen donors routinely for HIV and for infectious disease. Have there been any policy recommendations for the transplant community as of today or are they being worked on?

GOODMAN: Well, you know, HRSA regulates the organ transplant testing, but we've been working closely with them and I think many of the same principles apply.

I think you're right that this one instance of this organ transplant donor and the four recipients who developed infection is really the strongest case right now and is of great concern.

And you're also right that in many cases these people who choose to give this tremendous gift of organ donation may also donate tissues for a very diverse group of uses, and that we're concerned about the potential for spread of the disease through those.

So, you know, to summarize that, I think the same push to get a practical, valid test which would allow us to screen blood is extremely and directly relevant to tissues and we support it for the same reason.

FRIST: Can I -- do I have another minute, or about?

DURBIN: Certainly do.

FRIST: I want to just clarify this testing business, if we can. Let's try to.

Basically a serologic blood test and that is just by a PCR, is that right, polymerase chain reaction -- is that how it's done right now, the blood test?

GOODMAN: Well let me try to be helpful on that.

FRIST: My goal is to clear up for my colleagues and for people who're watching, right now we say that there's not a commercially available test to do all this mass screening...

GOODMAN: Right.

FRIST: ... which would be required for our blood supply, yet at the same time we're making this diagnosis in all the people who have either been exposed or died from it, it's confusing to people that you've got a test, the rest of the world does not have a test, and that being the case how do we take the sort of testing that you can do and be able to make it broadly available so we can have these screens?

And what incentives -- you say that's not your business to actually to commercialize it, but is there something that we can do to speed that process up as policy makers?

GOODMAN: OK. A series of excellent questions. The first one, which is covered in written testimony but I can answer now here, too, is a real difficulty.

Normally the disease is diagnosed in a clinical laboratory or a state or the health department or the CDC through the presence in the blood of antibody to the infection, an early form of antibody called IGM. Now, that test is currently available and is being used to diagnose this disease all over the United States.

FRIST: And so people understand, it's not...

GOODMAN: It's not the virus itself...

FRIST: ... it's not the virus itself but the reaction to the virus. You're measuring what the body -- the normal body response to the virus, so you're measuring that, not the virus.

GOODMAN: Exactly, this is measuring the host's response in terms of producing antibodies to fight off the infection. Now when a host does that, they rapidly appear to clear the virus from their blood. So the problem, from the issue of the blood supply, potentially, or the organ donor, is that those individuals are unlikely to have antibody in their blood.

In fact you could almost argue if they did they're probably at very low risk of transmitting the disease. So the same test that shows you that you might have West Nile virus does not -- in fact, does not correlate with showing you that you can transmit it to somebody.

And so in order to detect a risk for a blood or organ donor to transmit infection to somebody else, you have to find direct evidence of the virus itself, not of the person's response to the virus because it's too soon.

And as you mentioned the technologies for doing that have predominantly revolved around techniques which detect tiny amounts of the genes of the virus and amplify them to a level where they can be detectable.

PCR, or polymerase chain reaction, is one that's commonly utilized. There are other forms of nucleic acid amplification. These tests are more complex, more technologically demanding. But on the positive side, we have succeeded in putting those kinds of tests in place to further reduce tremendously the risk of HIV and hepatitis C transmission in the blood to the order of less than one in a million, or one in 2 million at this time.

So I think we're optimistic that some of this technology is adaptable.

DURBIN: Thank you, Senator Frist.

And Dr. Goodman, I'm sorry to hold the panel but I want to follow up on that question, because earlier when we asked you about the blood supply, if I understood your answer correctly, you said we do not have a valid test, a validated test at this point.

Perhaps in a year we might. We talked about the incentive for creating a mandate or requirement for the test so that private industry, private sector will respond with a test that we can use.

Then you went on to say that you were considering new questions when it came to blood donors, and you said if people exhibited flu- like symptoms that might be an indicator of at least some concern or caution.

But I thought, in just responding to Dr. Frist -- Senator Frist and Dr. Frist at the same time -- that you said if a person is asymptomatic, if they don't show any flu-like symptoms, they may still be carrying, because the antibodies are in their system they may still be carrying the West Nile virus.

GOODMAN: Right.

DURBIN: So asking the question, and they say "I don't have any flu-like symptoms," doesn't take us very far in terms of blood donors.

GOODMAN: Right. These are different components of steps to try to protect the American people from any risk here. OK, one is to protect people through the donor questions and calling back if people have symptoms who may have infection and may manifest symptoms.

But you're absolutely right, another concern is the patients who do not have or never develop symptoms. And for those, a procedure such as testing of blood is what would be needed.

And we would, this also connects to Dr. Frist's question, but with respect to the incentive to the industry et cetera, as I said the message I am getting I that they are taking this seriously and proceeding full-steam ahead. We are doing everything we can to push that level of preparedness and to do, as a regulatory agency, everything we can to facilitate that development.

But in the end, the issue of the motivation and the performance of the industry is probably best addressed with them. But I have a positive perception so far.

DURBIN: Thank you very much. And the senators who have arrived said that they will save questions for the second panel, and I'd want to thank this panel and I want to make certain that what was said here is understood clearly, and that I understood it clearly, in that, from Dr. Fauci, that we're not talking about a public health threat of the magnitude of the flu pandemic or AIDS disease.

In your words, "It is not trivial and must be taken seriously."

DURBIN: You anticipate, and I hope you're right, a decline in infections and deaths next year from this problem. Is that fair?

FAUCI: It is possible that that would happen. There's certainly no guarantee. But if it acts like other Flavy viruses have, where there's been waxing and waning, we can expect, maybe not next year, that there will be a waning. It is unusual that you would see this, but we're prepared for that occurrence.

DURBIN: And as far as a vaccine, a human vaccine, you say on a expedited schedule, three years is the likelihood of producing such a vaccine.

And Dr. Gerberding, what you've told us is, local units of government and health agencies are going to need help in dealing with this mosquito-borne illness, in terms of financial assistance. The $29 million this year has been helpful, but more will be needed in the future to deal with it. Is that correct?

GERBERDING: (OFF-MIKE)

DURBIN: All right.

Thank you very much, Dr. Goodman, Dr. Fauci and Dr. Gerberding, thanks for joining us.

And now we'll move to the second panel. I'll introduce them as they're being seated in the interest of time for my colleagues.

Dr. Sidney Houff, is here. He is the president and chairman of Loyola University Chicago's Department of Neurology. He'll discuss the steps health care providers are taking to identify infections associated with the West Nile virus, treat them and educate the public about risk factors. In addition, he'll outline how serious the threat is to humans, the methods currently being used to treat the illness associated with the virus.

Dr. John Lumpkin, my friend and an outstanding public service servant in the state of Illinois. We had a similar panel in Springfield in August. I'm glad you're here today.

Dr. Lumpkin is the director of the Illinois Department of Public Health and is going to outline our state's current efforts, as I mentioned before, to control the spread of the virus which has hit us particularly hard.

And then we're going to have Dr. Fay Boozman, director of the Arkansas Department of Health, to discuss additional challenges that state officials face when responding.

And one other witness, whom I'll ask Senator Landrieu to introduce.

LANDRIEU: The witness from Louisiana, a parish president, Nickie Monica, who represents a parish right outside of New Orleans -- actually, between New Orleans and East Baton Rouge. And Nickie has done an outstanding job, in terms of keeping the mosquito population down by very effective eradication program that is safe and is working.

And we wanted him to share some testimony, Mr. Chairman, about that. Because as much as we'd like to do the vaccine, the screening and the testing, I think our parishes and counties need some help with the appropriate kinds of spraying and pesticides that can be effective in making it safer and having the public feel safer. And so he is here to testify on that.

And thank you, Nickie.

DURBIN: Thank you, Senator Landrieu.

And at this point under the rules of the Senate Government Affairs Committee, I'll ask you all to please rise for the oath.

Do you solemnly swear that the testimony you're about to give is the truth, the whole truth and nothing but the truth, so help you God?

Let the record indicate that the witnesses have answered in the affirmative.

I'm sorry, Senator Hutchinson, I thought you'd left, but would you like to say a word about Dr. Boozman before they give their testimony?

HUTCHINSON: Mr. Chairman, I would only rarely correct you, but his name is pronounced Boozman.

DURBIN: Boozman, I'm sorry.

HUTCHINSON: And Dr. Boozman is our director of the state Department of Health in Arkansas. He's doing an outstanding job and is a very, very dear friend of mine. And we're glad to have him on our panel today.

Thank you, Mr. Chairman.

DURBIN: We thank you a lot.

Dr. Houff, would you like to be the first testifying?

HOUFF: Mr. Chairman, members of the committee, I want to thank you very much for the opportunity to be here today.

I am not only the professor and chair of neurology at Loyola University, but I like to tell you that I'm the chair of the steering committee for the Conservation Medicine Center of Chicago and the director of the Neuroscience and Aging Institute. And I think those are important because the Conservation Medicine Center is a collaborative effort between Loyola University, the Brookfield Zoo and the University of Illinois bringing a consortium of veterans, physicians and so forth together addressing this sort of problem.

I'd like to divide my testimony up into two aspects. One, I'd like to give you a clinical impression of what these patients are like. I've had the privilege and the honor of taking care of them. I'll give you some idea of what we are facing in the human area. And then speak to you as a neuro-virologist (ph) and someone responsible for designing and implementing studies of these kinds of illnesses.

First, I'd like to let you know that us in the medical community are privileged and pleased with the response of the CDC and state health departments. The response has been tremendous. It's been very informative and efficacious for us as physicians taking care of these patients. And I think that congratulations and debt of the medical community to these groups has been well-founded.

As far as the clinical aspects of this disease, it is my opinion we have seen some changes in the clinical manifestations of this disorder. In the past, the neurological complications have been mainly meningoencephalitis, that is an inflammation of the brain and the meninges covering of the brain with very little seen in what we call focal neurologic deficits. That is the deficits that cause paralysis or those sorts of things.

In the beginning in 1999, we did see what was called Gideon- Beret-like (ph) illness where people became profoundly weak with muscle pain. But in this episode or this enzootic (ph) what we've noticed is focal neurologic deficits have been more common. Now whether that's going to hold up true at the end of the epidemic when we look at all the cases, I don't know. But certainly in our experience in Chicago, that's been a prominent finding, that we've begun to see patients with optic nerve disease and blindness, anterior horn cell disease, some paralysis, Parkinson's-like syndromes and so forth during the acute illness. And so that really strikes to us is a change in the clinical picture may be occurring as this epidemic evolves over the years.

As far as treatment goes, as you know, it's very limited. We only have supportive therapy at the present time. We use steroids to reduce brain swelling. We use seizure medications to prevent seizures. And we support the patients. Unfortunately, as you know, that's not always possible to do and we have had deaths, both at Loyola and other institutions in Chicago.

As far as treatment, you've heard from Dr. Fauci what lays on the future. One of the things that I would emphasize is the possibility of using immuno-globulin therapy, gamma globulin therapy, antibody therapy for this.

We do know in neurological diseases in the past we've been successful with that. For instance, in enterovirus-like polio (ph), we've been able to treat patients who have low gamma globulin levels successfully with this type of therapy. And in Israel there's at least one case that I'm aware of that's been treated with serum containing high antibodies to West Nile virus and the patient survived. Whether that was a direct effect or not, I don't know.

But certainly that is something that you'd want to address quickly and bring to the forefront in a short period of time as a way to address a possible illness.

Switching gears and talking about what we don't know about West Nile virus and what I think would be a reasonable approach in the future. I think that Illinois has a very interesting history that may be quite illuminating if we approach it correctly.

As you know, Illinois was faced with a St. Louis encephalitis virus epidemic in the '70s which was quite severe. And as you heard earlier, St. Louis encephalitis and West Nile virus are both Flavy viruses.

And so one of the questions I think that behooves us to address in the future is, what is different here? What in the enzootic, what animal species, what avian species are infected? What mosquito specifics are infected? And why in this environment do we face so many animal cases and so many human cases?

HOUFF: And I think that Illinois offers us an opportunity to address those issues.

With that in mind, the Conservation Medicine Center of Chicago is now looking into designing studies to address those issues both in the animal population, the insect population and the human population.

Finally, I'd like to address surveillance, because I think this epidemic illustrates what we are up against. We've done a fine job of identifying things, and identifying West Nile virus, and plotting its development. But one of the things we have done over the years is close many of the surveillance centers around the world. As jet travel and human travel between countries has increased, we've decreased our surveillance efforts around the world. And I would encourage people who have the opportunity and the ability to think about reopening those to address emerging infections.

DURBIN: Excuse me, Doctor. Could you be specific when you say surveillance efforts -- what you're talking about?

HOUFF: Yes sir, I'll be glad to, Senator Durbin.

The Rockefeller Institute, for instance, has centers around the world that monitored arbor (ph) virus infections -- infections that were transmitted by insects and so forth. And those were closed as the years went by and they're not available anymore. So what we don't know is how are these viruses circulating in nature in other areas?

One of the questions that came earlier this morning was do we know where the West Nile virus circulates in the United States in animal populations and humans, as it does in Europe and the Middle East? And although we think we, do the actual studies that we need to do to address those issues specifically haven't been done and need to be done.

If you look at the epidemic in Israel, for instance, the United States we've had high avian die-offs in both. The Romanian epidemic was not associated with that, nor were there any other West Nile virus infections that I know of.

So these surveillance centers, I think, are very critical for the future.

DURBIN: Thank you very much, Dr. Houff.

Dr. Lumpkin?

LUMPKIN: Thank you, Mr. Chairman. And thank you for the opportunity, and the members of the committee, to speak and talk a little bit about our experience in Illinois.

Illinois, as you know, is one of the most severely impacted states in the nation. As of today, we'll be reporting in the neighborhood of 520 cases. There was at least one additional death we'll be reporting today, which will bring our total up to 28. This, obviously, has had a tremendous impact and it is not a trivial outbreak.

Our experience in Illinois began last year when we had our first case of bird that was found to be positive for West Nile.

We've had an avian surveillance system that's been in place; it's been in place since 1976. We, on average, collect about 5,000 birds. We trap them live, we draw blood and we've been testing since that time. And that surveillance system, as well as the collection of birds and other animals, gave us a heads-up that we were going to have problems.

We'd had in place a plan to begin to address West Nile through support from the Centers for Disease Control. Our first plan was put in place in May of 2001, prior to any case that's in Illinois. And then we developed a task force, under the direction of the governor, of state agencies that began to put our plans in place for this spring.

Our first case amongst birds was found in May and we saw an outbreak that really moved fairly slow until mid-July, in which case there was an explosive outbreak amongst the birds. And in many neighborhoods, and particularly in the Chicago area, it's been called the silent summer because birds have not been heard in many communities. There really has been a dramatic impact upon the bird population.

In response to this, and with the subsequent human cases, we began to use state resources that we had been made, grants to local health departments to develop plans prior to the human cases. But afterwards $3 million of state funding were made available.

This has created certain problems for us because, as we've looked at how to address the resources that we have available, and with the state, like many other states, having severe budget restrictions, we've essentially had to use money that currently would be available to local health departments to do food inspections, infectious disease control, inspections of water and sewage systems. And so we've had to dip into that fund and spend money that we really don't have in order to respond to West Nile.

We are currently engaged in active activity, the $3 million's been granted out to counties throughout the state that have had human cases. We have been focused in on doing larvaciding as well as integrated mosquito control. This integrated control has had an impact. We believe that our outbreak, obviously, would have been much worse had we not been able to do this sort of response.

I would like to talk about one issue that was raised and one that is of concern. We have a number of things in place in Illinois, surveillance and our response plan, basically because we responded to an outbreak in 1972. Since that time, many of the mosquito abatement districts at the local level have seen significant reductions in resources.

We as a nation and many communities tend to forget the lessons that we've learned from the past. And as such, it became incumbent upon the state to make resources available to local communities when those communities exhausted the resources that were available at the local level.

But an important question, I think, has to be raised. First is, do we really understand this disease and are we conducting studies in all the ways that we should?

The first panel talked about research that's going on in humans. I wonder whether or not we're doing adequate research amongst the avian population, the major reservoir. Do we fully understand this?

What will be the pattern? I don't think the answer will be in people, I think the answer will be in birds. What is their experience? Why are we seeing such a large bird die-off?

The second is is that when you look at the cases in Illinois, three-quarters of the cases in Illinois are in Cook County. Over half of those cases are in two distinct locations: the exact same locations that we had a major number of cases in 1975 in our St. Louis encephalitis outbreak.

DURBIN: Which locations are those?

LUMPKIN: That's the southwest side, mainly focused around the Oak Lawn area, Evergreen Park, Beverley, Morgan Park, that area. And on the north side, sort of, focused around Skokie, dipping into the city in that area.

I think that there is reason to do intensive study of those communities to find out what particular is about the bird population, mosquito population, that leads to the recurrence of this particular outbreak so severe in a virus that's very similar to St. Louis encephalitis. And I think we missed an opportunity to do that research in 1975, and we should not miss that opportunity to do that research this year because of the severity of the outbreak.

We're looking for assistance from the federal government. I think we've had a fair -- a good bit of assistance in the past, but we need to have additional research to better handle -- give us the kind of tools.

Some of the tools that we need, for instance, are how we conduct our bird surveillance. We collect blood samples from wild birds. I don't think we have adequate reagents to be able to test them as a very early warning system to be able to determine whether or not West Nile virus exists in those bird populations.

Understanding more about the biology of West Nile in the bird population is where additional research and as well as resources should be made available to the states and communities to better respond. Thank you.

DURBIN: Thanks a lot.

Mr. Monica, thank you for joining us?

MONICA: Mr. Chairman, members of the committee, I am Nickie Monica, parish president, St. John the Baptist Parish, and resident of the suburb of the New Orleans metropolitan area.

St. John's population is near 50,000 residents and is one of the fastest growing areas in the state of Louisiana. St. John is located on the Mississippi River, which has a substantial industrial job base that has brought significant economic development and higher-than- average wages to our area.

It is indeed a pleasure to appear before your subcommittee to shed some light on a growing local problem that has national implications.

Just a short time ago mosquitoes, like many other insects, were just another nuisance that interrupted the outdoor life of our residents. Unfortunately it has now been thrust into the national media that it's become a serious health hazard with devastating consequences to many families around this country, including those in my state of Louisiana.

Fortunately, Mr. Chairman, St. John's Parish has not yet experienced a human fatality, something I believe is due to our proactive measures to combat this growing public menace. However, if a more prominent effort is not put forth, I am fearful that it's just a matter of time before tragedy strikes home.

St. John the Baptist Parish initiated its own regimented mosquito control program over a decade ago. That was an added quality-of-life issue for our residents. This program is run by professional and licensed entomologists who are experienced in the field of surveillance and treatment.

Our spraying and treatment program experienced no problems until the West Nile virus became -- approached Louisiana from the Eastern Coast states. We immediately allocated 30 percent more funding to the spraying program without additional surveillance.

We also began a public awareness campaign to encourage residents to minimize the threat of larva hatchings around homes and businesses.

Additionally the Louisiana Department of Health and Hospitals initiated state-wide public service announcements reminding all residents to be vigilant and lessen the threat of infection. It is my opinion this has been effective in itself.

Even though St. John the Baptist Parish has an adequate control program in place, our financial ability to continue to fight over a sustained period of time is practically exhausted.

We all know this problem is not going away, the question is how best to fight and fund an effective program. The fact that parishes and cities that do have a program also have West Nile virus, and that is of great concern.

MONICA: Mr. Chairman, I know my own parish and state best, and have fought enough to provide the remedy to abate danger. We now have to look to the experts to tell us what is best -- the best protocol that can be implemented statewide.

It is definitely more than a local problem. It is a national and state health concern. And the federal government does need to play a major role in fighting and funding. Of course, any federal program must be consistent statewide in order to maximize abatement efforts.

Mr. Chairman, I also want to thank the Louisiana congressional delegation and the United States Congress for their efforts to assist Louisiana and the rest of the affected areas of our country in this effort.

For example, further federal assistance should immediately begin to provide rapid processing of birds and mosquito specimens submitted for virus testing. And that would be made possible by the Mosquito Abatement for Safety and Health Act, Senate Bill 2935 and introduced by Senators Breaux and Landrieu, legislation to would allow states and local governments to react more rapidly by providing funding to existing programs and states.

Too much time has been lost in reporting results that could further direct control efforts. The point of surveillance is to detect the virus before it spreads to human population. When weeks are required to report results, the advantage of an early warning system is lost.

Consequently immediate preparations and funding are needed to allow state laboratories to continue testing dead birds submitted by citizens, even after the virus activity has been detected in a particular parish or county. The additional data is vital in determining the exact location of the virus, which in turn allows more direct assignment of abatement resources.

The Congress should also allow continued emergency funding for expanded surveillance, for testing, and for state laboratories which will play a role in early detection of the virus. My parish needs assurance that emergency supplemental funds will be made available for additional mosquito control efforts should West Nile or any other mosquito-borne disease require a response beyond our local capabilities. This becomes particularly important when diseases couple with storms or manmade catastrophes that stretch available resources beyond their limits.

Mr. Chairman and members of the committee, this concludes my testimony. It would be the pleasure to be able to convey my thoughts on an important issue in a growing national health problem that will require a unified effort. I want to thank each of you for your participation. And I'll be available to answer any questions.

DURBIN: Thanks, Mr. Monica.

MONICA: Thank you, Mr. Chairman.

DURBIN: Dr. Boozman?

BOOZMAN: Thank you, Mr. Chairman and committee. I appreciate the opportunity to share with you.

I have been very appreciative of the experts that have been testifying to you, because they're the same experts we depend on to guide us. But I feel like the report I'm going to give you is somewhat of a blue collar report, in the sense that while vaccines are being developed and these very important questions that you've been asking are being looked at, we're faced on a daily basis with people contracting this disease and a need to deal with it.

I want to thank our partners at the CDC. They have been outstanding in giving us funding and being as flexible with that funding as they can be, and helping us to meet this crisis. They've been excellent in helping with our surveillance and our laboratory and the other things. And I think that money that you have already spent was wisely spent, and has done an awful lot.

There's been a lot of talk in the testimony about next year. And I certainly don't speak from any scientific perspective. I'm just looking at what's been happening.

This has gone down the East Coast. It's coming from the north. As a state health officer, I have to think we're going to have a bad year next year. The year we're having this year is very much like the year Louisiana had last year. And the disease burden is just growing. The virus burden is clearly growing. Last year we had four birds. This year, we're up in the hundreds of birds.

And so, I feel like that we've got to build on the knowledge we have -- as new knowledge is being developed, we've got to build on the knowledge we have. We know that larvaciding works. We know that getting rid of standing water and places where the mosquitoes can breed, education in those areas works.

Recently in Pine Bluff, Arkansas, which is our focal area where we have the most cases, they had a community cleanup. And the county judge told me that they did not pick up a single tire in that county that did not have growing mosquito larvae in it when they picked it up. So there's things that can be done that we need to be doing right now that we know needs to be done while we work out some of these very important questions.

In Arkansas, we estimate that a good comprehensive, integrated program of education, larvacide and then in those areas where we have significant human cases, adulticide, would cost in the neighborhood of about $5 million. This year...

(UNKNOWN): Excuse me, Doctor, you used the term adulticide?

BOOZMAN: Yes, of the mosquito. The adult mosquitoes. The spraying.

This year our governor released out of his emergency fund $1 million, which we specifically just used for larvaciding.

BOOZMAN: And larvaciding, I think is the most efficient and most cost-effective and safest in terms of a way to help control the mosquito population.

I think we certainly need to continue the surveillance activities that have already started. As Senator Frist mentioned in some of his questions earlier, there's an awful lot of overlap as we prepare for this with our preparations for bioterrorism. In fact, as we've responded to the West Nile through our communications, through the many different things we've done, I think it's made us much better able to respond to a bioterroristic event. And so, I think it's money that's actually have a good dual purpose: As our surveillance gets better for West Nile, it gets better for everything else also.

I think we've clearly seen that we've got to continue to invest in the capacity of our public health laboratories. We saw it with anthrax, and it's just been amplified with this, that we do not have the capabilities at the state level right now. There's not been much investment in public health laboratories for many years. And as a result of that, we need to continue to increase their capacities.

So in conclusion, Mr. Chairman, I think we must continue the funding that's been going on in surveillance, the additional funding we got that allowed us for the education. But I think there's got to be some additional funding for vector control of these mosquitoes. And also, though we've had some funding, I think there has to be a continued emphasis on getting our public health laboratories into shape.

Thank you, sir.

DURBIN: Thanks, Dr. Boozman.

Let me first ask of Dr. Lumpkin, you've focused on two areas in the Chicago area, which may be beyond our parochial interests since we're from the same state. And you indicated that the incidence of St. Louis encephalitis in these same two areas where you're seeing the prevalence now of West Nile virus infection is worthy of investigation. Could you follow up on that a little bit, and tell me, the 1975 that your referred to, was a similar situation with the death of the bird population, avian population?

LUMPKIN: I'm not aware that there was a similar death of the avian population. But I think we heard earlier testimony there were roughly 1,000 or more cases of St. Louis encephalitis that year. Almost 600 of those were in Illinois and there were 47 deaths. So it was the most intense experience with St. Louis encephalitis.

DURBIN: Mosquito-borne?

LUMPKIN: Mosquito-borne, intensified in birds. The difference between West Nile and St. Louis encephalitis is, the West Nile virus replicates much more rapidly than St. Louis encephalitis. So many of the conditions between West Nile and St. Louis encephalitis are very similar.

So if we had an intense experience in 1975, why? And if we have same intense experience with a similar kind of vector-borne, same, you know, mosquitoes and birds, why again?

And what we've learned with basic epidemiology is you identify the population that appears to be most at risk and you study them intensely to see if you can learn the kind of lessons that then become applicable to the general population. And we believe that that would be the case in the areas that are intensely involved in Illinois.

DURBIN: I think that is worth following up not just for our own protection, but perhaps for the lessons learned for other parts of the country.

And I just looked, back in July we announced some money, through the Department of Agriculture, for the state of Illinois, $750,000 to deal with this. And at the time I noted in my press release I made a point that there hadn't been any case of human infection on July 26th of this year. And here we are with, I believe, hundreds of cases of infections, including, incidentally, a young intern on my staff who w