[Senate Hearing 110-359]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 110-359
 
  CRACKS IN THE SYSTEM--AN EXAMINATION OF ONE TUBERCULOSIS PATIENT'S 
                   INTERNATIONAL PUBLIC HEALTH THREAT

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                      JUNE 6, 2007--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html


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                               __________
                      COMMITTEE ON APPROPRIATIONS

                ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii             THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont            TED STEVENS, Alaska
TOM HARKIN, Iowa                     ARLEN SPECTER, Pennsylvania
BARBARA A. MIKULSKI, Maryland        PETE V. DOMENICI, New Mexico
HERB KOHL, Wisconsin                 CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             MITCH McCONNELL, Kentucky
BYRON L. DORGAN, North Dakota        RICHARD C. SHELBY, Alabama
DIANNE FEINSTEIN, California         JUDD GREGG, New Hampshire
RICHARD J. DURBIN, Illinois          ROBERT F. BENNETT, Utah
TIM JOHNSON, South Dakota            LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana          KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island              SAM BROWNBACK, Kansas
FRANK R. LAUTENBERG, New Jersey      WAYNE ALLARD, Colorado
BEN NELSON, Nebraska                 LAMAR ALEXANDER, Tennessee
                    Charles Kieffer, Staff Director
                  Bruce Evans, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                       TOM HARKIN, Iowa, Chairman
DANIEL K. INOUYE, Hawaii             ARLEN SPECTER, Pennsylvania
HERB KOHL, Wisconsin                 THAD COCHRAN, Mississippi
PATTY MURRAY, Washington             JUDD GREGG, New Hampshire
MARY L. LANDRIEU, Louisiana          LARRY CRAIG, Idaho
RICHARD J. DURBIN, Illinois          KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island              TED STEVENS, Alaska
FRANK R. LAUTENBERG, New Jersey      RICHARD C. SHELBY, Alabama
                           Professional Staff
                              Ellen Murray
                              Erik Fatemi
                              Mark Laisch
                            Adrienne Hallett
                             Lisa Bernhardt
                       Bettilou Taylor (Minority)
                    Sudip Shrikant Parikh (Minority)

                         Administrative Support
                              Teri Curtin
                         Jeff Kratz (Minority)


                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening statement of Senator Tom Harkin..........................     1
Opening statement of Senator Arlen Specter.......................     3
Statement of Julie Gerberding, M.D., M.P.H., Director, Centers 
  for Disease Control and Prevention, Department of Health and 
  Human Services.................................................     4
    Prepared statement...........................................    11
Statement of Deborah J. Spero, Deputy Commissioner, United States 
  Customs and Border Protection, Department of Homeland Security.    17
    Prepared statement...........................................    19
Statement of Anthony S. Fauci, M.D., Director, National Institute 
  of Allergy and Infectious Diseases, National Institutes of 
  Health, Department of Health and Human Services................    22
Statement of Senator Sherrod Brown...............................    35
Statement of Andrew Speaker, Speaker Law Firm, Atlanta, Georgia..    42
Statement of Steven Katkowsky, M.D., director, Department of 
  Health and Wellness, Fulton County, Georgia....................    45
Statement of Nils Daulaire, M.D., M.P.H., president and chief 
  executive officer, Global Health Council.......................    48
    Prepared statement...........................................    50


  CRACKS IN THE SYSTEM--AN EXAMINATION OF ONE TUBERCULOSIS PATIENT'S 
                   INTERNATIONAL PUBLIC HEALTH THREAT

                              ----------                              


                        WEDNESDAY, JUNE 6, 2007

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:48 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Specter, Cochran, and Gregg.
    Also present: Senator Brown.


                opening statement of senator tom harkin


    Senator Harkin. Before we proceed, we're trying to get a 
witness who could not be here, to be here, at least 
telephonically. We had hoped to have it visually also, but 
there seems to be some problems at National Jewish Hospital 
hooking us up. But we're going to have Mr. Speaker, I hope, 
telephonically here momentarily. I just want to make sure that 
we have him so that he can hear the proceedings as we proceed, 
because Mr. Speaker will be on our second panel.
    Hello; is this Mr. Speaker? This is Senator Harkin in 
Washington. Can you hear us?
    Mr. Speaker [by telephone]. Say it again?
    Senator Harkin. Mr. Speaker, this is Senator Harkin, 
chairman of the subcommittee. We are just--I just called the 
meeting to order. I just want to make sure that you could hear 
the proceedings. Are you hearing the proceedings now? Can you 
hear me?
    Mr. Speaker. Yes. What is this meeting for?
    Senator Harkin. What did he say?
    Mr. Speaker. What is this meeting for?
    Senator Harkin. I'm sorry. This is the Subcommittee on 
Labor-HHS that has jurisdiction over NIH and the Centers for 
Disease Control. This hearing is to basically look into the 
circumstances surrounding the events of the last few weeks 
concerning your case and what needs to be done to ensure that 
things like this don't happen in the future. That's the subject 
of this hearing.
    We had hoped to have you hooked up visually, but there seem 
to be some problems in Colorado with that. But we have you 
telephonically. So I just ask you to listen to the proceedings, 
and then we have one panel. I will lay that out for you. You'll 
hear that. Then you'll be our witness on the second panel.
    Do you understand that?
    [No response.]
    Well, while they're trying to get the bugs worked out of 
this: I'm sure everyone has heard now about the case of Andrew 
Speaker, the person who we just heard briefly on the phone, who 
was diagnosed with an active drug-resistant form of 
tuberculosis. On May 10, Mr. Speaker flew from Atlanta on a 12-
day international odyssey, which he continued despite warnings 
from the Centers for Disease Control and Prevention. Then he 
reentered the United States at the Canadian border when a 
Customs agent allowed him to pass, despite knowing that Mr. 
Speaker was being sought by health authorities. During this 
hearing we'll hear testimony from Mr. Speaker by live hookup. 
At least I hope we will.
    Obviously, this case raises grave questions on how prepared 
we are as a Nation to prevent the spread of a dangerous 
infectious disease. This subcommittee, under the leadership of 
Senator Specter and myself, has made it one of its top 
priorities, if not the top priority, to make sure that our 
public health infrastructure is adequately funded to respond to 
natural or man-made biological threats. We have provided funds 
for disease surveillance here and abroad. We have invested in 
the Centers for Disease Control and Prevention and our State 
and local public health systems. We have funded research in 
vaccine development. We have Dr. Fauci here to speak about 
that. We have held hearings on bioterrorism and on pandemic 
flu, numerous hearings, under the leadership of Senator 
Specter.
    We did this because we know that public health, both on the 
Federal and local levels, is our first line of defense against 
new and existing infectious diseases. We did this because we 
knew the threats we face from both bioterrorism and emerging 
infectious diseases, for example SARS or pandemic flu. In the 
case of pandemic flu, we know that we have to count on public 
health because with an outbreak we will have to wait perhaps 
months before we have an adequate vaccine after an outbreak.
    That's why I'm dismayed and concerned that so many things 
went wrong in this case of a drug-resistant tuberculosis. This 
is not the first and will not be the last time that we count on 
our public health system to keep us safe.
    Some things went right. The doctor who first diagnosed the 
TB in the Atlanta man did indeed report the case to the local 
health department. The local health department did respond and 
either suggested or directed--I don't know which--that the 
patient not travel overseas.
    But then the records kind of get confused and a little less 
clear. Clearly there are some gaps in planning on how to 
control the travel of persons with dangerous infectious 
diseases. It's as though the issue had not been raised before. 
We'll get into that with Dr. Gerberding.
    We're told that there were legal issues to resolve. Well, 
we need to know what those are, but it seems to me that sound 
planning calls for resolving those issues in advance. That's 
where I really want to kind of guide and direct this hearing as 
to what happened in the planning to take care of a case like 
this.
    The purpose of this hearing again is to learn more about 
what happened and, more importantly, to learn what's being done 
to prevent something like this from happening again. Bear in 
mind that an incident like this could have happened on a cruise 
ship, a train, commuter subways, wherever. We need to be 
planning for these kinds of possibilities and we need to test 
those plans, to test them to see if they'll work in the real 
world.
    So this hearing will give us an opportunity to learn more 
about also the growing problem of drug-resistant tuberculosis 
and other drug-resistant infectious diseases, what's being done 
and should be done to address those threats. That's where we'll 
get with Dr. Fauci on those.
    With that, I'd yield to my colleague and again person who 
has led this committee for so many years in making sure that we 
had funding for CDC that we have funding for NIH, to make sure 
that we're able to address these issues if and when they arise. 
So I'll yield to my good friend Senator Specter.


               opening statement of senator arlen specter


    Senator Specter. Thank you, Mr. Chairman. I commend you for 
this prompt hearing on this very important subject. There is 
worldwide concern about what has happened with this incident 
involving Mr. Andrew Speaker and his worldwide travels to marry 
and honeymoon. When you have the World Health Organization 
criticizing the United States Centers for Disease Control, it 
raises very, very important questions which we have to 
determine precisely what Andrew Speaker was told, by whom.
    There is an apparent conflict between what the doctors say 
and what Mr. Speaker says. The doctors say, reportedly, that he 
was warned that he ought not to travel and that he would place 
himself at risk and many, many other people substantially at 
risk. He was told, according to what he has to say, that 
they're technically required to advise him, in effect it was 
really up to him, they had discharged their duties. Well, if 
that is so that's a very serious dereliction.
    But that's what we have to make a determination of, as to 
who said what to whom when and what the emphasis was, and who's 
responsible for this international incident. Then, as Senator 
Harkin correctly states, the issue is where do we go from here, 
how do we prevent such a recurrence, how do we assure the World 
Health Organization and the people in other countries, those 
who travel on U.S. planes, that they're not at risk, that we 
have some sensible way for making a determination as to who is 
contagious and to what extent.
    I thank you, Senator Harkin, for summarizing what this 
committee has done. I don't think any subcommittee has been 
more diligent about health issues than this committee. This 
room has been the situs since December 1998, just 10 days after 
we found out about embryonic stem cells, to hold 20 hearings. 
This subcommittee has taken the lead in taking a look at the 
building facilities at the Centers for Disease Control in 1999, 
found them in a shambles, and found $1.5 billion to reconstruct 
the CDC, to say nothing of your leadership last year on 
initiating $7 billion for fighting the risk of pandemic flu.
    So in essence, Dr. Gerberding, Dr. Fauci, Ms. Spero, we 
want something for our money. It has been a lot of money and we 
expect some high-level performance. Everything that I have seen 
of CDC has done that. But now we have a serious issue which has 
been raised here.
    I'm going to have to excuse myself. We are on the 
immigration bill. It's all over the front pages, and the 
majority leader has threatened to take the bill down unless 
cloture is invoked, something you don't want to hear about, and 
unless we dispose of a great many amendments. We started this 
morning at 8:30 to set a schedule and we have a long list of 
amendments, and my presence is required there. But I will do my 
best to come back. I've had some experience in questioning 
witnesses and I'd like to see what Mr. Speaker has to say 
firsthand.
    So thank you again, Senator Harkin.
    Senator Harkin. Thank you very much, Senator Specter.
    I will say that one other facet that I didn't mention is 
how this person slipped through the border, even the alert had 
gone out and everything, and that's why Ms. Spero is here. We 
want to find out, again, what do we need to do? How did this 
happen and what do we need to do, again, to make sure that 
people who are identified like that can't just come across the 
border like he did. So that's the reason that Ms. Spero is 
here, to respond to that.
    So we'll open the hearing with Dr. Gerberding. Dr. 
Gerberding, no stranger to this subcommittee, Director of the 
Centers for Disease Control and Prevention. Dr. Gerberding has 
been a great leader, I would say this for the public record, of 
the Centers for Disease Control and Prevention and in guiding 
it through a huge building phase and again has worked very 
closely with this subcommittee in helping us to know where to 
put the money for surveillance and early detection, and 
especially ramping up for the possibility of pandemic flu.
    So Ms. Gerberding, Dr. Gerberding, we welcome you again to 
the subcommittee. Normally we have a 5-minute rule, but I will 
waive that and go ahead and leave the record open for any other 
opening statements that people have. But go ahead and take 
whatever time necessary. At around 10 minutes we may start to 
get a little nervous, but if you have to take that time go 
ahead. Again, welcome, and please proceed.

STATEMENT OF JULIE GERBERDING, M.D., M.P.H., DIRECTOR, 
            CENTERS FOR DISEASE CONTROL AND PREVENTION, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Dr. Gerberding. Thank you, so much, Senator. I do want to 
acknowledge the statements made by both you and Senator 
Specter. This committee truly has been incredibly supportive 
and interested in protecting the health of our Nation and 
really people around the world, and I think Dr. Fauci and I 
will both agree that we are very fortunate to have that kind of 
support for our agencies.
    What I'd like to do very quickly is to talk about what 
should have happened in this situation, what actually did 
happen in this situation, and what do we need to change to make 
sure that the problems that occurred don't happen again. So I'm 
actually very grateful to have the opportunity to be able to 
talk through this because I've been frustrated by some of the 
accounts that I've been reading and not really having a good 
forum to be able to kind of lay out the whole story and address 
questions in a straightforward manner. So I really do 
appreciate it.
    You know, I'm a doctor and long before I had this role I 
was a doctor at San Francisco General Hospital and I took care 
of lots of patients with tuberculosis. Many of them were 
medically indigent and poor people and we had to face----
    Senator Harkin. Excuse me. I was hoping to have Mr. Speaker 
so he could hear the proceedings. He really is a witness for 
our second panel and, like anyone; I wanted to make sure he 
could hear the proceedings before. I thought we had him before.
    Well, we'll try to get him in between the panels. I'm 
sorry, Dr. Gerberding. We will not be interrupted again. Go 
ahead.
    Dr. Gerberding. Thank you. As I was just starting to 
mention, I've had a lot of experience as a doctor with patients 
with tuberculosis in an urban environment, and I know how 
important it is to balance the care and empathy that you have 
for the patient with your responsibility to protect people's 
health. I just want to say very overtly in this case that as a 
doctor I have enormous empathy for this patient and certainly 
his bride and his family and all of the stresses this whole 
situation has caused to them. He's got a very serious illness 
and I'm glad he's in the right place and I hope he gets the 
right treatment. Everything looks promising at this point in 
time, but we have to remember that above all we're dealing with 
an individual who has a very serious disease and I think that 
needs to be behind our thinking in all of these cases.
    Let me talk a little bit about what should have happened 
here. Since 2002 there have been 72,000 cases of TB diagnosed 
in the United States. Each time a case of TB is diagnosed, it 
needs to be tested for drug-resistance, health officials need 
to be notified, and appropriate steps need to be taken to make 
sure the patient gets treatment and the public is protected 
from exposure during the period of contagion.
    Seventy-two thousand cases represents the total of cases 
since I've been the CDC Director, and I can tell you in that 
period of time I have never had to issue a Federal order of 
isolation until this time. In fact, our records indicate we 
haven't issued a Federal order of quarantine since 1963, when a 
quarantine order was issued for smallpox, and I don't think any 
CDC Director has ever had to issue an order for tuberculosis. 
So this is a really unprecedented and unusual situation. The 
vast majority of times in the last 5 years of TB cases have 
been managed by local and State health officials without this 
kind of complication. The system has worked very well to 
protect the public's health, and on the handful of cases local 
isolation orders have had to occur, occasionally State 
isolation orders have been invoked. But we've always been able 
to make the system work on behalf of both the patient and the 
public. So we have to understand what changed in this 
particular situation.
    Now, in this case what should have happened is that the 
diagnosis should have been made, the drug susceptibility 
testing should have been done, and health officials should have 
been alerted. Those things were done. There's been some 
confusion about why did it take so long to know that he had XDR 
TB and the reason for that is this is a very slow-growing 
organism and it takes a long time to do the test when the 
organism is slow-growing. So there's nothing about the time 
line from diagnosis of the disease to diagnosis of drug 
resistance that is unusual, although there are some new 
opportunities that Dr. Fauci might talk about to speed up that 
process using new technology and new diagnostics that are in 
the pipeline.
    The patient was prescribed traditional four-drug first line 
therapy, but once it was learned that he had multi-drug-
resistant TB that treatment would have been ineffective, and so 
he was essentially untreated until he ended up at National 
Jewish and could be started on therapy.
    The local public health officials assessed the risk. They 
determined that it was not zero. They recommended measures to 
protect others. Basically, in the vast majority of situations 
like this they operate under a covenant of trust. They give 
advice to the patient, they explain what needs to be done to 
provide protection. Patients generally cooperate. As I said, 
almost all of them cooperate with that experience. Certainly, 
in my own experience I've never been in a situation where we 
were as surprised to see a patient choose a different route. 
But of course, in this situation the patient had very 
compelling reasons to make an alternative judgment about what 
was in the best interests of himself and the people around him.
    In Georgia, if a patient is to be isolated in an 
involuntary manner it takes a court order and the patient must 
first demonstrate that he is not compliant with medical advice. 
So the State could not issue such an order until the patient 
actually did something that was against medical advice. That's 
the way the laws in Georgia are written.
    If the State felt that they couldn't isolate the patient, 
they could contact CDC to determine whether or not we could use 
our Federal quarantine authorities in this case. Our 
authorities allow us to act when the State fails to contain the 
patient. They allow us to act in a situation of interstate 
movement, when a patient's moving from one State to another. 
They're written to act, to allow us to prevent the importation 
of tuberculosis into our country. So those are conditions in 
which we can issue a Federal order of isolation.
    We recognize that in this case everyone was giving the 
patient the benefit of the doubt and assuming that we would be 
able to find a way to satisfy our public health 
responsibilities as well as his personal needs.
    On May 10, I don't know from a CDC perspective what was 
said in a meeting, but--because our quarantine officer was not 
present, but I do know that the health department met with the 
patient to explain his drug-resistant tuberculosis and what 
needed to be done, and following that meeting Georgia 
Department of Health did contact the quarantine officer at CDC 
and request information on what to do if the patient did not 
follow medical advice and made a decision to travel 
internationally. So we were contacted to ask what options did 
exist if a patient did not follow the advice of the health 
department and made alternative decisions, and that advice was 
provided by the quarantine officer. The e-mail from the Geogia 
State Health Department did not contain specifics and indicated 
travel was intened in 3 weeks.
    We know the next day the patient made a decision to contact 
the airlines and move up his flight date and then traveled on 
the 12th to Europe. His fiancee did not change her plans 
apparently and traveled on the 14th, as the patient had 
originally intended.
    On May 18, CDC was notified by the health department that 
the patient might be in Greece. So we contacted airlines to try 
to ascertain if in fact he had flown out of the United States 
and went to Greece. We were able to contact Delta, which was 
the plane that he was scheduled to fly on the 14th, and we 
looked at the days 3 days before, 3 days after. The airline was 
very cooperative, could not find any information suggesting 
that the patient had left the country. So we had no 
documentation.
    During this time we were also on the Internet trying to 
find the patient's addresses, telephone numbers, the father's 
telephone numbers, and so forth, trying to track down family 
members, including the father-in-law of the patient and his 
father, to see if we could contact them by cell phone or by 
other means to figure out their whereabouts. We were 
unsuccessful in contacting them during this period of time.
    On May 22, our laboratory determined that the patient 
actually had extensively drug-resistant TB, a form of TB that's 
extremely difficult to identify and to treat. CDC contacted the 
Customs and Border Protection and asked them to put the patient 
on the lookout watch list because of this extensively drug 
resistant tuberculosis (XDR TB). They were very cooperative. We 
were able to learn when the patient was scheduled to return. 
They were able to put that alert out for all of their border 
officers and that day we were able to make contact with the 
patient's father-in-law by cell phone. He was able to tell us 
that yes, in fact the patient had been in Greece, they were 
traveling internationally, they were on their honeymoon, he 
didn't know where they were; he would try to contact them.
    About 12:30 a.m. in Rome on May 23, the patient did in fact 
return CDC's messages and contact CDC in a very cooperative 
mode, as his family had asked him to do, and we were able to 
have conversations with him while he was in Italy. Granted, it 
was late at night for him; those conversations went on over the 
next 24 hours.
    The communication from CDC focused in three areas. One is 
to inform the patient that he must not fly on commercial 
airlines because he had extensively drug-resistant TB. The 
second was that it was important that he report to a chest 
hospital in Italy so he could be evaluated. We were concerned 
that since he hadn't been treated in the last 2 months he could 
be getting sicker and potentially more infectious and that he 
needed to be seen by a medical physician so that we would have 
information about what other decisions and options were 
available.
    We also provided the patient with information about what 
the options might be for bringing him home, either in the short 
term or in the long term. As the U.S. Government, the policy in 
the State Department is that travelers have to provide their 
own transportation home if they have a medical emergency, 
including a communicable disease. But we felt in this 
situation, since he was not only a risk to himself but a risk 
to other people that we really should try to see if we could do 
something to facilitate and help him get home.
    Options we considered included an air ambulance, which his 
insurer may or may not have paid for, and we made efforts to 
contact Kaiser Insurance beginning that day when we found out 
who his insurer was to try to ascertain if Kaiser could help 
us. We also contacted USAMRIID because the military has an 
isolator that they can roll on or off aircraft and put patients 
in respiratory isolation to bring them home without posing a 
risk to the pilots or the crew. That option was not immediately 
available and it would have taken some time to get TRANSCOM to 
order a military aircraft, and how we would pay and reimburse 
the DOD for that was something that we had not planned for and 
that's an area in our action plan that we need to go back and 
revisit.
    We also considered CDC aircraft. CDC has two small 
airplanes that we have to have available 24/7 to support our 
Strategic National Stockpile and we have the CDC aircraft that 
this committee has helped us support in the context of SARS and 
the many public health emergencies where we've had to take a 
fast action and move samples or people or specimens very 
quickly.
    Unfortunately, our aircraft is not configured to allow safe 
transport of patients with respiratory diseases that require 
isolation. There is no way to completely separate the air in 
the airplane from the pilots or the crew of the aircraft. We 
used the same plane when we flew the patient from New York to 
Atlanta, but in that case it was a short flight. It's not a 
short flight from Europe to Atlanta and so we were just not 
able to safely orchestrate this.
    We tried to think of various things we could do to rig the 
system to make the plane air-safe, but we really could not 
transport the patient in respiratory isolation. We have a gap 
there in our ability to move patients forward.
    But I want to be completely clear that we looked at every 
option and we have done a lot of analysis since that time to 
figure out how can we close this gap in our ability to 
transport a patient who requires respiratory isolation. Keep in 
mind that at that time we did not know how infectious the 
patient really was because he'd not been successfully treated 
at any point in time.
    The patient understandably was probably frightened. Here he 
was on his honeymoon. He's told now he's got extensively drug-
resistant tuberculosis. He's told he has to go to a hospital he 
knows nothing about. We asked him to call the Embassy, to the 
travel assistance program, because the State Department has a 
loan program to help travelers whose insurance or private means 
don't allow them to get home.
    So there are many options that we presented, but I think in 
retrospect, the bottom line was the patient was fearful he was 
going to be isolated out of his own country and made a personal 
decision to travel, as he put it, underground to avoid any 
detention that could really provide a severe restriction of his 
movement over the long run.
    So even though there was a border lookout for the patient, 
he was able to get into the United States through a very 
specific error that Homeland Security has addressed, accounted 
for, and is in the process of correcting when he returned 
across the border into the United States from Canada. But after 
he crossed the border, CDC made contact with him. He was 
cooperative. He went to Bellevue Hospital in New York City, as 
we asked him to do. The patient was immediately met by CDC's 
quarantine medical officer in New York City.
    We issued the Federal isolation order there. He was 
hospitalized for evaluation. His sputums were checked. He was 
smear-negative (subsequently, culture positive once again), as 
he is still smear-negative in Denver Jewish. What that really 
means is that, while his cultures are positive, he can transmit 
TB, he's not highly infectious, meaning he does not have so 
many bacteria that you can directly see them under the 
microscope but he is infectious nonetheless. I think his care 
and management from that point forward is clear to everyone.
    So basically here we are in a situation where we have tried 
to balance the need to respect the patient's needs and wants 
and emotional state and compelling needs with our requirement 
to try to protect the people's health. We gave the patient the 
benefit of the doubt at several points here and in those cases 
we failed to take the aggressive action that we could have used 
with legally sanctioned methods to restrict his movement more 
effectively.
    Let me just define those three places so we can be 
explicitly clear. First of all, up front before the patient 
left the United States, we believe that we could strengthen our 
States' ability to restrict the movement of patients before 
they demonstrate noncompliance with a medical order. If we 
believe the patient has a strong intent to put others at risk, 
we need to have confidence we can take action absent 
documentation of intent to cause harm.
    We also think we need clarification in the quarantine 
statute. It does not explicitly address exportation, meaning 
movement of patients out of the country. It expressly addresses 
importation and movement of patients from one State to another. 
So we may be able to use the existing statute with a 
clarification of intent, but we do need to identify what our 
responsibilities and authorities are under the statute and make 
a decision about whether a change is needed.
    I want to emphasize this because the whole history of 
quarantine has been devoted to keeping people out and 
containing them, and it is the first time that we've really had 
to address keeping people in our country. So our statutes 
weren't really designed with this modern age of global travel 
and the vast multiple dimensions of international travel that 
we experience.
    The second point I want to make is about the speed of 
notification. There were several ways in which CDC made 
required notifications in this event. I mentioned we notified 
the Customs and Border Protection to help us try to prevent the 
patient from entering the country. We also cooperated with TSA 
to put in a no-fly order. I have to say, every time Homeland 
Security was very helpful to us and stepped up to the plate to 
try to facilitate what we were trying to do, even though this 
was the first time they'd been in this situation of trying to 
use their tools and authorities for an infectious disease 
threat.
    We know that we can fine-tune our notification, but when 
you look at the whole time line of this event, even if we had 
notified in all of these cases sooner, it would not have 
prevented the patient's movement, nor would it have prevented 
the passenger exposures on the flights. So we need to notify 
faster, but it would not have prevented the problems that were 
seen.
    We did notify the World Health Organization about a half a 
day later than we should have. When we contacted the World 
Health Organization to tell them that we had a patient that we 
couldn't locate, who may be exposing people in Europe, they 
notified us that they did not consider this to be a public 
health emergency of global significance, they were not going to 
take action, but when we had more specifics and more specific 
information that there were passengers at risk to get back to 
them and they would respond.
    So when we got the travel information of the patient's 
itinerary, we returned that information to the World Health 
Organization and at that point they contacted ministers of 
health and CDC initiated the process of contact investigation 
for the travelers along with international partners.
    The last point of improvement I believe is our ability to 
move patients with respiratorily transmitted diseases in 
aircraft. We would love it if everyone had private insurance 
that paid for med-evac, but most people don't, and that's an 
alert to passengers that they need to look at their own 
insurance options when they travel. We would love it if we had 
a large pot of money so any person in the United States who had 
a problem abroad could be paid to have transport home by their 
government. I don't think that's going to be realistic.
    But when we're in a situation where someone is putting 
someone else at risk by flying commercially, we need to be able 
to move that person safely home in an appropriate aircraft. We 
have a plan to reconfigure the craft that we have at CDC. We're 
hoping that we'll be able to have the authority to go ahead and 
make that configuration change so that we don't have to ever 
have this conversation again. It's my belief that if the 
patient could have been reassured of affordable and safe 
transport home that he would have been unlikely to fly home 
commercially and we could have eliminated a great deal of the 
difficulty for at least those passengers flying from 
Czechoslovakia to Canada.
    So our after-action review process has already begun. Last 
Tuesday we gathered all accountable CDC parties together, went 
through this in great detail, began to patch together the time 
line, which I'm sure will evolve and improve as we get 
information from other people, and have begun to initiate 
actions to change.
    One of those actions involves DHS and we've already agreed 
that we can accelerate all of this communication about 
notification by simply having the CDC operation center go 
through the Secretary's operation center right to the national 
operation center. So DEOC to SOC to NOC will get us into a mode 
where Homeland Security can make the entire cascade of 
notification work effectively.
    We also have initiated an internal review at CDC to assure 
that all of the conduct of CDC employees, including the father-
in-law, is consistent with ethical standards. We're making sure 
our biohazard and safety procedures are appropriate and that 
there is no situation involving CDC or CDC employees that was a 
problem here.
    Last, we have made the decision, to assure the objectivity 
of this process, to work with the inspector general's office to 
have a look at the conduct of the CDC employee, who I'm sure 
was torn between his responsibilities as a CDC scientist and 
his role as father of the bride in this particular situation. I 
want to emphasize his cooperation with us.
    Then last, we'd like to bring forward to the committee our 
plan for configuring our aircraft to allow us to move patients 
in respiratory isolation.


                           prepared statement


    So let me close by thanking you for your patience. You know 
I'm also in the very embarrassing situation of having to be at 
another hearing simultaneously to this one, so you let me go 
first. I would really like to make myself available to you 
after the Q and A in the future if there are any other 
questions that the committee would have for me that I can't 
stay for in the second panel.
    So thank you very much and I hope this has been helpful.
    [The statement follows:]
             Prepared Statement of Dr. Julie L. Gerberding
    Good morning, I am Dr. Julie Gerberding, Director of the Centers 
for Disease Control and Prevention within the Department of Health and 
Human Services (HHS). Chairman Harkin, ranking member specter, and 
other distinguished members of the Subcommittee, it is my pleasure to 
be here to discuss with you CDC's ongoing investigation of a U.S. 
traveler recently diagnosed with extensively drug resistant 
tuberculosis. Before I move to the specifics of this investigation, I 
want to highlight the priority CDC places on global health protection 
and disease prevention at home and abroad. CDC's four guiding Health 
Protection Goals--Healthy People in Every Stage of Life, Healthy People 
in Healthy Places, People Prepared for Emerging Health Threats, and 
Healthy People in a Healthy World--serve to focus our programmatic 
efforts and financial investments to achieve the greatest health 
impact, and this case has reinforced the critical importance of each of 
these goals.
    CDC's goal of Healthy People in a Healthy World prioritizes our 
global health activities to assure that people around the world will 
live safer, healthier and longer lives through health promotion, health 
protection, and health diplomacy. The current XDR TB situation has 
involved many public health officials from around the world who acted 
together to protect people's health in a circumstance where an 
individual with drug resistant tuberculosis may have served as a source 
of exposure. I want to thank the public health officials from around 
the world that came together in a network of public health protection 
to work through the complexities involved in this case and take steps 
necessary to protect the public's health. It serves as a reminder as we 
move into the era of emerging infectious diseases that we need to 
assure that this global health protection network works every time for 
everyone, anywhere. And CDC will continue to provide leadership and 
assistance to our global health partners to strengthen that network 
further as we go forward. This statement highlights some of the key 
local, State, Federal and international partnerships that contribute to 
this global health protection network. I will begin by providing some 
background information on tuberculosis before describing CDC's role in 
responding the current XDR TB case.

                               definition

    Tuberculosis is an airborne infectious disease that is spread from 
person to person, usually through coughing, sneezing, speaking, or 
singing. In the late 19th and early 20th centuries, until the 
introduction of streptomycin in the 1940's, TB was one of the leading 
causes of death in the United States. Currently, the World Health 
Organization (WHO) reports that one in three people in the world are 
infected with dormant or latent TB. TB is a slow growing bacterium that 
often takes weeks to culture. Only when the bacteria become active do 
people become ill with TB. Bacteria become active as a result of 
anything that reduces the person's immunity, such as HIV, advancing 
age, or some medical conditions. TB bacteria can also become active in 
individuals that are not immunocompromised. Currently, TB that is not 
resistant to drugs can be treated with a six to nine month course of 
``first-line drugs'' (the most effective), including isoniazid and 
rifampin; this treatment cures over 95 percent of patients. However, 
since people in many resource-poor countries lack access to appropriate 
treatment, nearly 9 million people in the world develop TB disease each 
year and about 1.6 million die.
    TB that is resistant to at least isoniazid and rifampin is called 
multidrug-resistant (MDR) TB. MDR TB requires treatment for 18-24 
months with ``second-line drugs'' that are much less effective, often 
poorly tolerated by the patient, and far more costly. The cure rate is 
70-80 percent under optimal conditions, but is usually closer to 50 
percent. Many countries with a high TB burden find it impossible to 
treat MDR TB patients because of the cost of second-line drugs, and the 
more sophisticated laboratory services to diagnose resistance to drugs, 
and more intensive programmatic support required to administer the 
drugs. Extensively drug-resistant TB (XDR TB) is a subset of MDR TB 
caused by strains of bacteria that are resistant to the most effective 
first- and second-line drugs. Reported mortality rates among persons 
with XDR TB are extremely high. Among non-immunocompromised persons, 
reports indicate that less than 30 percent of patients can be cured, 
and more than half of those with XDR TB die within 5 years of 
diagnosis. Among im- 
munocompromised persons, illness is more severe, and mortality rates 
are even higher and death occurs within a shorter time.
    The risk of transmitting any type of TB can depend on several 
factors, including the extent of disease in the patient with TB, the 
duration of exposure, and ventilation. Both regular TB and drug-
resistant TB bacilli become aerosolized when a person with TB disease 
of the lungs or throat coughs, sneezes, speaks, or sings. These bacilli 
can float in the air for several hours, depending on the environment. 
Persons who breathe air containing these TB bacilli are at risk for 
becoming infected.

                          scope of the problem

    In response to anecdotal reports from physicians who were finding 
cases of TB that were unresponsive to the first-line and second-line TB 
drugs, in 2005 HHS/CDC and WHO jointly conducted a survey, with support 
from the U.S. Agency for International Development, which examined 
about 18,000 patient specimens tested during 2000 to 2004 by 
Supranational Reference Laboratories. Researchers examined the drug-
resistant isolates, and found that 10 percent of the MDR TB isolates 
actually met the definition for XDR TB. XDR TB was identified in 17 
countries from all regions of the world, most frequently in the former 
Soviet Union and other Asian countries. However because many countries 
do not routinely test all isolates for resistance to second line drugs, 
the precise global incidence of XDR TB remains uncertain. Because of 
the ease with which drug resistance can occur (due to the use of 
second-line drugs in suboptimal conditions, changes in program focus 
away from TB case management, interruptions in drug availability 
because of supply management/resource availability/patient drug 
noncompliance, high HIV prevalence), XDR TB could be much more 
widespread than this survey shows. The ability of the disease to 
develop resistance to treatments and to travel easily across borders 
makes worldwide TB control efforts critical.

                 tb and the threat to the united states

    Between 1993 and 2006 in the United States, there were 49 cases of 
XDR TB reported to HHS/CDC. By comparison, 13,767 TB cases (a rate of 
4.6 cases per 100,000 persons) were reported in the United States in 
2006 (the most recent year of aggregate annual reporting). The 2006 TB 
rate was the lowest recorded since national reporting began in 1953. 
While the total number of MDR and XDR TB cases is relatively small, 
their impact on U.S. TB control programs can be significant in terms of 
human capital and financial resources. One patient with MDR or XDR TB 
requires a minimum of 18-24 months of treatment. Recently collected 
data show that in-patient costs alone can average $500,000 per case.
    XDR TB continues to be widely distributed geographically abroad and 
is cause for public health concern in the United States, though the 
overall domestic risk of XDR TB currently appears to be relatively low. 
However, due to the ease with which TB can spread, and given its 
significant health consequences, XDR TB will continue to pose a serious 
risk to the United States, as long as it exists anywhere.

    tb prevention and control: public health partnerships in action

    Generally, TB is a condition that is detected and treated by 
medical care practitioners. As with other infectious diseases, State, 
local, and territorial health departments serve important functions to 
support and augment the medical care system. These ``front line'' 
public health agencies are in direct contact with medical care 
providers and patients, providing important TB control services such as 
laboratory support, surveillance, contact tracing, and patient 
counseling. These agencies also generally possess legal authority to 
isolate or quarantine patients in those rare instances where 
traditional doctor-patient relationships or other means have failed to 
protect the community.
    At the Federal level, HHS/CDC serves several critical roles in 
controlling TB. First, HHS/CDC provides leadership and scientific 
support for TB control efforts, both nationally and internationally, 
including our global efforts to eliminate TB and stem the emergence of 
XDR TB as a health threat. Secondly, HHS/CDC provides approximately 
$100 million annually in support to State, local, and territorial 
health departments for TB control efforts. Third, State and local 
public health departments routinely test samples of respiratory 
secretions from patients in order to diagnose tuberculosis and for some 
State laboratories, including Georgia, HHS/CDC routinely conducts 
second line drug susceptibility testing. HHS/CDC receives isolates from 
approximately 20 State laboratories each year as part of those 
laboratories' regular referral process. Each year HHS/CDC conducts drug 
susceptibility tests for approximately 1,000 samples. Fourth, HHS/CDC 
has the capacity to assist State or local authorities with its 
scientific resources. HHS/CDC may also use its Federal legal 
authorities to prevent the introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States or 
between U.S. States. As I will describe, HHS/CDC's involvement in the 
recent case spanned all of these roles.

     the current xdr tb investigation: locate, isolate, transport, 
                              investigate

    The following narrative is based on information assembled and 
reviewed in time for this testimony. The ongoing HHS/CDC investigation 
involves a U.S. citizen with potentially infectious XDR TB who traveled 
to and from Europe on commercial flights. In late March, the patient 
was diagnosed with TB by his doctor. Once diagnosed, Fulton County 
Health Officials became involved in managing the potential public 
health risk to others.
    On May 10, the Fulton County Health Department became aware that 
the patient's TB strain was resistant to the first-line of antibiotic 
treatments. This same day, the county health department met with the 
patient and his family to inform them of the diagnosis of MDR TB. Our 
understanding, from conversations with the county health officials, is 
that they orally advised the patient to forego his planned travel 
abroad. On the evening of May 10, the Georgia Health Department emailed 
HHS/CDC's Atlanta Quarantine Station and reported that they were aware 
of an MDR TB patient (patient was not identified) that may intend to 
travel in three weeks. HHS/CDC exchanged emails with the Georgia Health 
Department with options to prevent travel including written 
notification under local authority. In the days following this meeting, 
Fulton County Health Officials attempted to serve the patient with 
written notice advising that the patient not travel, but the patient 
could not be located at either his residence or business.
    It should be noted that normally when a patient has tuberculosis, 
he or she voluntarily complies with recommended treatment and 
recommendations to ensure that they don't put themselves in situations 
where they could potentially expose others to a serious health threat. 
Public health practitioners have a high success record using voluntary 
means of information and advice. In fact, the vast majority of TB 
patients comply with treatment recommendations, including remaining in 
isolation units in hospitals or in isolation at home until 
infectiousness has resolved without the need to invoke State or local 
legal authorities. It is extremely rare that Federal quarantine or 
isolation authority is required to manage domestic TB cases.
    On May 18 after the patient left the United States, HHS/CDC's 
Division of Global Migration and Quarantine was notified that the 
patient traveled internationally against medical advice and his 
whereabouts were unknown. At this point, HHS/CDC's public health 
mission focused on locating the patient, isolating him, ensuring safe 
transportation and contact tracing. Between May 18 through the 22, HHS/
CDC worked with Fulton County health department, Georgia State 
Department of Health, commercial airlines and the patient's family to 
locate him. In addition, on May 22, HHS/CDC laboratories determined 
that the patient had the rarer and deadlier subtype of XDR TB.
    On May 22, HHS/CDC quarantine officials requested that the Customs 
and Border Protection (CBP) Atlanta office arrange to have the patient 
detained upon re-entry to the United States. On both May 22 and 23, 
HHS/CDC spoke with the patient in Rome, Italy and informed him of his 
XDR TB diagnosis; explained the severity of the disease; instructed him 
to terminate all travel and to cease use of commercial air carriers; 
and initiated conversations about the need for isolation, treatment, 
and travel alternatives. Despite assurances from the patient that he 
would not travel, it was discovered, on May 24, that the patient had 
checked out of his hotel.
    With the patient's exact location and intention to travel unknown, 
HHS/CDC contacted the Transportation Security Administration (TSA) on 
May 24 and requested them to exercise their authority to prevent the 
patient from boarding a commercial aircraft and thereby mitigating the 
risk of transmitting the disease on another long-distance commercial 
flight destined for the United States. On May 25, HHS/CDC learned from 
CBP that the patient had traveled via commercial airliner from the 
Czech Republic to Canada and subsequently reentered the United States 
the previous evening. HHS/CDC then notified the Public Health Agency of 
Canada and requested they initiate efforts to get the passenger 
manifest of the patient's inbound flight to North America. HHS/CDC 
called WHO in Geneva on May 24 and the HHS Secretary's Operations 
Center, the designated Focal Point for the United States under the 
revised International Health Regulations (2005), officially notified 
the WHO Secretariat of the case on May 25, even though the Regulations 
do not come into force for the United States until July 17, 2007.
    On May 25, after repeated prior attempts, HHS/CDC officials made 
contact with the patient on his cell phone and directed him to report 
immediately to the Bellevue Hospital in New York City where he would be 
served a quarantine order for isolation and be evaluated. He followed 
this direction, and at Bellevue was served a Federal order of 
provisional isolation and medical examination authorizing medical 
evaluation and respiratory isolation for 72 hours for extensively-drug 
resistant tuberculosis (XDR TB). The patient was later safely 
transported to Grady Hospital in Atlanta, Georgia via HHS/CDC aircraft 
and was issued a Federal order that mandated continued isolation on 
arrival in Atlanta, GA. As part of this process, the patient was 
advised that he could request an administrative hearing to review the 
order but he did not request such a hearing. On May 31, he was safely 
transported by private airplane to National Jewish Medical Center in 
Denver, Colorado accompanied by his wife and a CDC quarantine officer. 
On June 2, HHS/CDC rescinded the Federal quarantine order for isolation 
because Denver health officials assumed public health responsibility 
for this patient. The patient is currently under the quarantine 
authority of Denver County.
    HHS/CDC is currently investigating the source of the patient's XDR 
TB. HHS/CDC is conducting an epidemiological investigation to look back 
at the patient's activities prior to his diagnosis in hopes of learning 
the source of the exposure. The patient has a history of travel to 
numerous locations outside of the United States. Sequences of DNA from 
the patient's TB strain do not match any currently on file in HHS/CDC's 
TB fingerprinting library. HHS/CDC is making efforts to compare it with 
TB fingerprinting libraries in other countries.

                 hhs/cdc recommendations for passengers

    Though the risk of transmission to the other passengers on the 
flights the patient took is low, it is not zero. In accordance with the 
WHO TB and Airline Travel Guidelines, and to ensure appropriate follow-
up and care for persons who may have been exposed to XDR TB, HHS/CDC 
has recommended that passengers aboard the two transatlantic flights 
longer than 8 hours in duration who were seated in the same row as the 
patient, those seated in the two rows ahead and the two rows behind, 
and cabin crew members working in the same cabin should be evaluated 
for TB infection. This includes initial evaluation and testing with re-
evaluation 8-10 weeks later. Because undiagnosed, latent TB exists in 
the general population, it is reasonable to expect that some of the 
passengers will test positive because of a previous exposure to TB, and 
not because of exposure on the flight in question. While we believe 
that passengers seated outside the immediate vicinity of the patient 
are at extremely low risk of contracting XDR TB, given the serious 
consequences and limited treatment options of XDR TB, we are notifying 
all U.S. residents and citizens on these flights and encouraging these 
individuals to seek TB testing and evaluation.
    HHS/CDC is taking the lead in contact tracing of the U.S. citizens 
on these flights and is coordinating with other countries for the 
contact tracing of their citizens. As of June 5, HHS/CDC has had direct 
contact with 245 of the approximately 276 U.S. citizens and residents 
on Air France 385. Of the 26 high priority passengers, seated in the 
same row, two rows in front or two rows behind the patient, HHS/CDC has 
spoken directly with 24 of these individuals.

            isolation and quarantine, an hhs-dhs partnership

    To contain the spread of a contagious illness, public health 
authorities rely on many strategies. Two of these strategies are 
isolation and quarantine. Both aim to control exposure to infected or 
potentially infected persons, and both may be undertaken voluntarily or 
compelled by public health authorities. The two strategies differ in 
that isolation generally applies to persons who are known or suspected 
to have a communicable disease, and quarantine generally applies to 
those who have been exposed to a communicable disease but who may or 
may not become ill. Isolation is a standard procedure used in hospitals 
today for patients with tuberculosis (TB), and in most cases isolation 
is voluntary; however, many levels of government (Federal, State, and 
local) have basic authority to compel isolation of infected people to 
protect the public. State and local governments have primary 
responsibility for isolation and quarantine within their borders and 
conduct these activities in accordance with their respective laws and 
policies.
    The Department of Health and Human Services has authority under 
section 361 of the Public Health Service Act to prevent the 
introduction, transmission, and spread of communicable diseases from 
foreign countries into the United States and between States. HHS/CDC, 
through its Division of Global Migration and Quarantine, is authorized 
to detain, medically examine, or conditionally release persons 
suspected of carrying certain specified communicable diseases. The 
communicable diseases for which Federal isolation and quarantine are 
authorized are established by Presidential order and currently include 
infectious TB, cholera, diphtheria, plague, smallpox, yellow fever, 
viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and 
influenza with pandemic potential.
    HHS/CDC relies primarily upon DHS for the enforcement of isolation 
and quarantine orders at the borders, but may also rely on other 
Federal law enforcement agencies and State and local law enforcement. 
By statute, our DHS partners at the borders--Customs and Border 
Protection (CBP) and Coast Guard officers--aid in the enforcement of 
rules and regulations relating to quarantine and isolation. Violation 
of Federal regulations regarding quarantine and isolation constitute a 
criminal misdemeanor, punishable by fine and/or imprisonment. Federal 
public health authority includes the authority to release persons from 
quarantine or isolation on the condition that they comply with medical 
monitoring and surveillance.
    HHS/CDC maintains a close partnership with DHS and its agencies. 
DHS and HHS signed a memorandum of understanding (MOU) in 2005 that 
establishes specific cooperation mechanisms as part of a broad 
framework for cooperation to enhance the Nation's preparedness against 
the introduction, transmission, and spread of quarantinable and serious 
communicable diseases from foreign countries into the States, 
territories, and possessions of the United States. DHS has charged the 
Homeland Security Institute with facilitating the implementation of the 
MOU and HHS/CDC's Division of Global Migration and Quarantine is 
collaborating in this effort. Concurrently, HHS/CDC has conducted table 
top exercises at ports of entry in cooperation with DHS' component 
agencies and State and local partners to develop and refine 
communicable disease response plans.
    The partnership between CBP and HHS/CDC is particularly vital, as 
CBP officers act as HHS/CDC's ``eyes and ears'' on the ground. In 
addition to assisting with the enforcement of Federal quarantine and 
isolation, HHS/CDC helps to train CBP officers to identify and respond 
to travelers, animals, and cargo that may pose an infectious disease 
threat. CBP also assists quarantine officials with the distribution of 
health risk communication materials for the traveling public, such as 
notices that alert travelers of possible exposure to communicable 
disease threats abroad and offer guidance on steps they can take to 
protect themselves.

                   next steps, what more can be done

    With the support of Congress and the President, and in accordance 
with the recommendations of the Institute of Medicine (IOM), HHS/CDC is 
investing in building a Quarantine and Migration Health System that 
meets the needs of the 21st Century. HHS/CDC is enhancing the numbers 
and competencies of staff, training, physical space, and utilization of 
technology to meet the Quarantine System's evolving, expanding role. 
This has included the creation of additional quarantine stations at 
airports and other major ports of entry into the United States. HHS/CDC 
has expanded this critical public health infrastructure to 20 stations 
and is focusing on fully staffing these stations.
    By continuing to expand the capacity of the U.S. Quarantine and 
Migration Health System through science, partnership, and preparedness, 
HHS/CDC will be better equipped to play an active role in worldwide 
biosurveillance, to coordinate nationwide response to global microbial 
threats of public health significance and to protect the U.S. public 
from communicable disease threats. The President has requested an 
additional $10 million in fiscal year 2008 to support the further 
enhancement and expansion of the Quarantine and Migration Health 
System.
    In addition, HHS/CDC has been working to update interstate and 
foreign quarantine regulations [42 CFR Parts 70 & 71] to codify 
procedures that more completely reflect the 21st century implementation 
of disease containment measures such as isolation and quarantine, and 
that strengthen the nation's public health security at ports of entry. 
On November 30, 2005, HHS/CDC published a notice of proposed rulemaking 
(NPRM) to update the interstate and foreign quarantine regulations [42 
CFR Parts 70 & 71]. Once adopted, these changes will represent the 
first significant changes to these regulations in 25 years.
    Key provisions proposed include: more explicit due process 
protections for written orders and an administrative review hearing; 
expanded reporting of ill passengers on board air carriers; and 
requirements that will facilitate the timely transmittal of passenger 
and crew contact information to HHS/CDC to ensure quick notification of 
exposure to communicable disease threats. These procedures are expected 
to expedite and improve HHS/CDC operations by allowing immediate 
medical follow-up of potentially infected passengers and their 
contacts. HHS/CDC received over 500 pages of comments from 
approximately 50 organizations and individuals regarding the proposed 
rule. HHS/CDC is currently addressing issues raised during the public 
comment periods, including working with DHS to most efficiently share 
contact information, and developing a draft final rule.
    To control TB, HHS/CDC and its partners must continue to apply 
fundamental principles including: (1) State and local TB programs must 
be adequately prepared to identify and treat TB patients so that 
further drug resistant cases can be prevented; (2) TB training and 
consultation must be widely available so that private health care 
providers recognize and promptly report tuberculosis to the public 
health system; (3) State and local public health laboratories must be 
able to efficiently perform and interpret drug susceptibility and 
genotyping results in TB specimens; and (4) CDC and local health 
authorities must work collaboratively to ensure that isolation and 
quarantine authorities are properly and timely exercised in appropriate 
cases.
    The prospects for development of new TB drugs also are promising 
and those efforts must continue. There are at least 4 new anti-TB 
compounds entering human trials while others are in advanced 
preclinical testing. These new compounds represent new drug classes 
that may offer promise for treating resistant cases.

                               conclusion

    We have begun a careful review of our protocols and capabilities. 
First and foremost, we are reminded that infectious diseases are not a 
thing of the past, and that we need to continually adapt our prevention 
and response capabilities in an era of increasing threat and 
globalization. We are reminded that almost all infectious disease cases 
are effectively handled within our existing systems of care by 
patients, clinicians and local public health authorities, and that it 
is important to continue to reinforce and augment these existing roles 
and relationships. Our public health protection network assisted us in 
responding to this event in a more timely and coordinated manner. 
Public health officials continue a long tradition of working together 
on every level to identify, contain and mitigate the spread of 
communicable diseases in U.S. communities and abroad.
    The case also reminds us that there are a number of existing 
channels that we can leverage more effectively in the future. Through 
the Global Health Security Action Group--a group of senior policy 
officials, top scientists, and media experts from the ministries of 
health of G-7 nations, Mexico, the World Health Organization and the 
European Commission--we can quickly convene relevant public health 
officials via phone and video conferences to convey information on 
cases like this to our key allies in a more timely and effective way.
    In an age of global air travel, infectious diseases can, and do, 
cross geographic borders every day. People can be infected with a 
disease and have few visible indications, people can vary in terms of 
how infectious they are, it is often not possible to rapidly test and 
confirm whether a person has an infectious disease, and people's health 
status can change quickly and unpredictably. We will never be in a 
position where we can guarantee that infectious people will not cross 
borders, but we will work to ensure that the measures available are as 
effective as possible. And so too this case reinforces the need to 
advance our efforts to modernize our Quarantine and Migration Health 
System and update Federal quarantine regulations; improve our 
information technology and communications capabilities; and define and 
exercise our capabilities and relationships with international, 
Federal, State, and local partners so that we are prepared to deal with 
situations that pose a threat to public health. We believe the lessons 
learned from this case will improve HHS/CDC's ability to protect the 
Nation's health in our ever-changing global environment.

    Senator Harkin. Thank you, Dr. Gerberding. Are you telling 
me that you can't stay?
    Dr. Gerberding. No, I'm staying for what we're doing right 
now. But on the second panel, there's a House hearing going on 
at the same time and they are expecting me there probably 
already.
    Senator Harkin. Well then, thank you very much, Dr. 
Gerberding. I allowed you to go beyond time because I wanted to 
get you on and make it clear on the record the position of CDC. 
But there are a lot of questions I'm sure that I and others 
have regarding CDC and the time line and why things weren't 
done at a certain time.
    But I think it's important to go to Ms. Spero now, 
basically, Ms. Spero, to answer the question of why this person 
got through the border. Ms. Spero is Deputy Commissioner of the 
United States Customs and Border Protection of the Department 
of Homeland Security. We wanted you here basically to let us 
know how this guy got across the border, Ms. Spero. Please 
proceed.

STATEMENT OF DEBORAH J. SPERO, DEPUTY COMMISSIONER, 
            UNITED STATES CUSTOMS AND BORDER 
            PROTECTION, DEPARTMENT OF HOMELAND SECURITY
    Ms. Spero. Thank you, Chairman Harkin, and good morning to 
you and the distinguished members of this committee. I am here 
before you today to discuss the role of U.S. Customs and Border 
Protection, CBP, in the Federal Government's efforts in late 
May to track down a U.S. citizen, Mr. Andrew Speaker, who was 
traveling with his wife internationally while he was infected 
with a rare strain of tuberculosis. I hope to provide you with 
such additional details as can be discussed in this forum of 
what happened when a CBP officer encountered the traveler and 
his wife crossing the land border with Canada at the Port of 
Champlain, New York, and allowed them to enter the United 
States contrary to CBP instructions. We will also update you on 
our resulting follow-up actions.
    Let me state at the outset, CBP had an opportunity to 
detain Mr. Speaker at the border and missed. That missed 
opportunity was inexcusable and it appears at this stage to be 
largely the result of a CBP officer failing to follow 
procedures and instructions. That failure is felt collectively 
by all of CBP's leadership and the front-line employees whose 
good work and reputations are tarnished by such actions. There 
is no criticism that can be leveled today or in the coming 
weeks by outsiders any harsher than the blame and frustration 
we have already turned on ourselves since the discovery of Mr. 
Speaker's entry into the United States on May 24.
    The failure to detain this traveler unfortunately 
overshadows and negates a lot of the good work done in this 
particular case by CBP employees both before and after the 
encounter at Champlain. Specifically, the work of our other 
employees began in Atlanta on May 22, when CDC contacted our 
local field office about Mr. Speaker. As a result of this 
contact, on that day a nationwide alert was placed in our 
electronic systems that gave us the necessary information to 
intercept the traveler despite not knowing how or where he 
would attempt to enter.
    We continued our efforts looking for Mr. Speaker's travel 
to the United States in the event he chose an alternate time, 
date, and method of travel. When it was determined by our 
national targeting center that the traveler had entered, we 
alerted the CDC within hours of the entry.
    Our efforts continued last week with CBP employees using 
our tools and information to identify Mr. Speaker's travel 
pattern and helped track down other passengers from his flights 
who are potentially at risk for tuberculosis from exposure to 
him.
    Also overshadowed is all the good work of CBP officers on a 
daily basis. Just to put this incident in context, on that 
date, May 24, at the Port of Champlain, New York, we processed 
the entry of 1,296 vehicles, 1,378 commercial trucks, and we 
responded to numerous alerts that were properly referred for 
secondary inspection. Nationwide, on an average day CBP 
processes 1.1 million passengers and pedestrians, almost 71,000 
trucks, rail and sea containers, over 240,000 incoming 
international air passengers, 327,000 incoming privately owned 
vehicles, and over 85,000 shipments of goods in just 1 day.
    What should have been a textbook success story to 
demonstrate the effectiveness of our officers in carrying out 
their responsibilities and the value of our technology systems 
was overshadowed by the failure to stop this one traveler. 
There is no excuse or acceptable explanation to offer for 
failing to stop this individual at the border. I do not believe 
that it can be explained by any lack of tools or training, and 
I can assure you that the actions of the individual officer and 
the supervisors in Champlain are being fully investigated and 
appropriate action will be taken.
    Because there is a required administrative process, I may 
not be able to say as much as I would like to today about these 
personnel actions. However, in a closed briefing we would be 
happy to provide the members with more detail on what took 
place in those critical few minutes in Champlain, New York.
    In addition to the ongoing process with respect to the 
particular incident, we have taken some immediate steps in CBP 
to implement enhancements to our information technology systems 
and our protocols at the ports of entry to further reduce the 
possibility that a single officer on primary inspection could 
ignore clear instructions about a public health alert in the 
same manner ever again.
    I would like to take a moment if I may in defense of the 
human element on the front line of America's borders and in all 
law enforcement that has been critically questioned during the 
past few weeks. While the human element, as we've seen, can be 
a weakness, it is also the source of our greatest strength. A 
great many of the threats we intercept on a daily basis at our 
ports of entry are caught not because of known alerts or watch 
lists already in a computer, but because of the training, the 
experience, and the judgment of our front-line officers in 
dealing with the unknown. It is the unknown threat that is 
still our greatest vulnerability.
    We were in fact presented with such a threat in the 
Millennium Bomber incident, who was intercepted at the border 
with a car trunk containing explosives on his way to blow up a 
terminal at LAX in 1999. This is an example of an alert Customs 
inspector who acted, not because the traveler was a known 
threat or on a watch list, but because the inspector could rely 
on her judgment, her training, and her experience to determine 
that something wasn't right with that traveler.
    It was another front-line officer, this time a former 
Immigration inspector in Orlando, Florida, who in August 2001 
denied entry to a Saudi national named Mohamed al-Qitani. 
Whether or not al-Qitani was, as thought by many, to be the 
20th hijacker in the 9/11 tragedy, he was at a minimum an al 
Qaeda-trained terrorist. Again, this outstanding employee, now 
a CBP officer, used his training, his experience, and his 
judgment to deny entry to someone who in all probability would 
have tried to do harm to our citizens.
    So it is important that, despite this most recent failure, 
we not lose sight of the value of that human element in 
inspection work and the dedication and daily contributions of 
CBP's front-line work force to the security of our country. 
Those who signed up to protect the homeland understand that we 
are expected to take the right action every single time. When 
we hit the mark, there will be precious little news because 
that is just doing our job. When we slip even once, it makes 
headlines. We accept that high standard of success without 
complaint because the mission is so important.

                           PREPARED STATEMENT

    I will not offer any hollow promises today that human 
failings will never again occur among the 44,000 employees 
charged with the critical and complex mission of securing our 
Nation's borders. Similarly, I cannot guarantee that CBP will 
hit 100 percent success 100 percent of the time. But this 
incident has reinvigorated our focus on the mission of 
protecting the American people. It's caused us to reexamine how 
we perform that mission and reinforce in a way words cannot the 
critical importance of every single employee doing his or her 
duty.
    Thank you and I would be happy to answer any questions.
    [The statement follows:]

                 Prepared Statement of Deborah J. Spero

                              introduction

    Thank you Mr. Chairman for the opportunity to share with the 
committee some of the policy, procedures and processes we have in place 
with our Federal partners for the Nation's biodefense across our 
borders.
    DHS is aware that the committee is acutely interested in the 
details and implications of the recent interactions with a patient 
infected with extensively drug resistant tuberculosis (XDR TB). We 
appreciate the opportunity to address this case with you and the 
actions we have taken to improve our biodefense posture. While this 
case is indeed interesting, it is extremely important to note that it 
poses no ongoing threat to public health in the United States.
    The system created to effect an isolation order involves the 
Department of Health and Human Services (HHS), (including its Centers 
for Disease Control and Prevention (CDC)) acting under the authority of 
the Public Health Service Act and the Department of Homeland Security 
(DHS). The system functioned properly in this case. However, there 
appears to have been a single point of failure in this case--human 
error by an individual who may have failed to follow appropriate 
procedures. DHS continues to investigate this issue. While the 
investigation is pending, DHS has ensured that the individual is not 
carrying out inspection duties at the border.
    The fact that a failure occurred underscores the need to implement 
additional failsafe mechanisms. U.S. Customs and Border Protection 
(CBP) has already made changes to its procedures designed to prevent 
this particular failure from occurring again. This was indeed a lesson 
learned and not simply a lesson observed.
    The committee has also expressed its concern, which the Department 
shares, about the implications of this incident for biodefense at our 
Nation's borders. We share the genuine concern over the fact that our 
borders are not impervious to infectious diseases, in spite of the best 
efforts of the CDC and DHS and its components. Unless draconian health 
screening techniques are routinely implemented at each port of entry as 
a standard operating procedure for the millions of people crossing the 
border, there will always be opportunities for people who are ill to 
cross our borders undetected. The land border environment presents 
additional challenges because individuals claiming United States and 
Canadian citizenship are not always required to present passports that 
validate identity and citizenship. The Department is committed to 
addressing this security gap through implementation of the Western 
Hemisphere Travel Initiative (WHTI). Ultimately, the WHTI will provide 
technical enablers and controls to mitigate volume issues and ensure 
that high risk travelers are better identified at our ports of entry. 
WHTI implementation will enhance the screening process by increasing 
the number of travelers that can be efficiently queried at the time of 
entry through the ports of entry based on better documentation, 
identity and citizenship.
    Currently, however, CBP officers are only able to query 
approximately 50 percent of land border crossers by requesting 
documents with machine readable zones (as noted previously, because 
individuals claiming U.S. and Canadian citizenship are not yet required 
to present documents denoting identity and citizenship) or by flat-
fingering the query. In addition, the great majority of our 327 ports 
of entry are manned by law enforcement officials from CBP who have 
received no advanced medical training. CBP officers do have procedures 
to follow when a U.S. citizen or non-U.S. citizen appears to be ill and 
in need of medical attention at the border, and each is trained in 
those procedures. These procedures involve consulting medical 
personnel. Federal medical resources at the borders come from the CDC's 
Division of Global Migration and Quarantine (DGMQ), which provides that 
service at approximately 20 ports of entry. Even though steps were 
taken to fortify ports of entry with medical staff, even fully staffed 
quarantine stations are not in a position to perform routine health 
screening on all passengers crossing the border as a standard operating 
procedure. It is important to stress that individuals will not 
necessarily exhibit symptoms of illness and that CBP officer must make 
their best assessment within a limited period of time.

                        the incident in question

    On May 22, 2007, CBP Port of Atlanta received information from the 
CDC regarding an individual, who traveled to Europe on May 12, 2007, 
noting that he is a carrier of a drug resistant form of tuberculosis.
    A shift muster, a daily briefing for shift employees on significant 
policy and operational matters, was distributed and briefed to CBP 
Officers at all locations.
    On May 24, 2007, at 18:18 hours, the individual arrived at the land 
border crossing at the Champlain, NY port of entry in a rental vehicle, 
accompanied by his wife.
    More detailed information can be provided in a classified briefing. 
However, as a result of this incident, CBP initiated a systems 
enhancement (effective June 5, 2007) that will help ensure that 
officers will follow appropriate procedures when processing persons of 
interest seeking to enter the United States. This systems change will 
allow CBP to better account for and control all referred persons of 
interest for secondary inspection. It will also require that such 
persons undergo additional questioning and examination to determine 
whether they may be cleared or whether other appropriate action is 
warranted. The Department's long-term solution remains a WHTI enabled 
screening procedure that tackles the inherent problem of increasingly 
high traffic volume with improved query capabilities.

             information sharing--united states and canada

    In December 2001, former Secretary of Homeland Security Tom Ridge, 
then serving as Director of the White House Office of Homeland 
Security, signed a Smart Border Declaration with the Canadian Deputy 
Prime Minister. The Declaration set forth a 30-point action plan 
designed to enhance the security of the United States and Canadian 
shared border while continuing to facilitate the flow of legitimate 
travelers and cargo. This action plan resulted in initiatives to share 
information between the United States and Canada related to air travel, 
including Advanced Passenger Information/Passenger Name Record (API/
PNR) Risk Assessments.
    An essential goal of the API/PNR Risk Assessment Initiative is the 
concentration of inspection resources on high-risk travelers while 
facilitating the movement of legitimate members of the general 
traveling population. A risk assessment process evaluates passengers 
arriving into the United States or Canada.

 current health screening procedures at ports of entry and information 
            sharing among cdc, cbp, and other dhs components

    As part of CDC's authority to prevent the introduction, 
transmission, and spread of communicable diseases into the United 
States, its possessions, and territories, CDC is authorized to isolate 
and/or quarantine arriving persons reasonably believed to be infected 
with or exposed to specified quarantinable diseases and to detain 
carriers and cargo infected with a communicable disease. DHS has agreed 
to assist CDC in the execution and enforcement of these authorities, 
primarily in the enforcement of CDC-issued quarantine orders, and 
through collaboration with other Federal, State, and local law 
enforcement entities.
    HHS and DHS executed a Memorandum of Understanding in October 2005 
that details the roles and responsibilities of each Department and 
agency to mitigate the entry of infectious diseases at the Nation's 
borders. (within HHS this memorandum implemented through the CDC.) 
Since the CDC's DGMQ cannot possibly cover every port of entry, 
successful screening depends on CBP officers having access to simple, 
usable tools and protocols to identify travelers who may be infected 
with a quarantinable disease. By the same token, CBP has law 
enforcement powers to aid CDC in carrying out its authorities and has 
access to data that CDC needs to perform its public health duties.
    HHS will consult with DHS to define steps necessary to obtain 
information expeditiously when either agency believes there is a public 
health emergency. The Departments agreed to assist one another in 
informing the traveling public of potential disease threats, including 
assisting in the distribution and dissemination of CDC Travel Notices 
or Health Alert Notices if necessary and as resources permit.
    DHS has agreed that its personnel will assist with surveillance for 
quarantinable or serious communicable diseases of public health 
significance among persons arriving in the United States from foreign 
countries, with the understanding that DHS personnel may not have 
medical training and therefore are not expected to physically examine 
or diagnose illness among arriving travelers. Surveillance by DHS 
personnel would generally consist of the recognition and reporting of 
overt visible signs of illness or information about possible illness 
provided to them in the course of their routine interactions with 
arriving passengers, and does not include eliciting a medical history 
or performance of a medical examination. In situations where a 
significant outbreak of a quarantinable disease is detected abroad, CDC 
may request that DHS personnel assist with active surveillance, using a 
number of methods to assess the risk that individual passengers, 
arriving from affected countries or regions, are carrying a 
quarantinable disease. CDC will ensure that a quarantine officer or 
designated official with public health training will be available to 
assist in the evaluation of individuals identified through active 
surveillance.
    CDC has statutory authority to require reporting of ill travelers, 
conduct certain public health inspections of carriers and cargo, and 
impose certain entry requirements for carriers and cargo that may pose 
a communicable disease threat. DHS will aid CDC in the enforcement of 
its statutory authority regarding quarantine rules and regulations 
pursuant to operational guidelines to be developed by mutual agreement 
of the parties. Such guidelines will include emergency measures to be 
taken when a carrier or vessel is determined, after leaving a foreign 
port, to be carrying a passenger or passengers with a quarantinable or 
serious communicable disease.

  passengers with potential public health threats and the commercial 
                                airlines

    Under the Aviation and Transportation Security Act, the 
Transportation Security Administration (TSA) has broad authority to 
assess and address threats to transportation and passenger security. 
Under this authority, TSA can direct airlines to deny boarding to an 
individual identified by the CDC as a threat; this includes individuals 
identified by the CDC as a public health threat. Based on the request 
from CDC/HHS, the Assistant Secretary of Homeland Security at TSA may 
determine that the presence of such an individual aboard a commercial 
passenger airline flight poses a threat not only to that flight but to 
the entire transportation system, should the disease spread to other 
passengers, flights and flight crews, and other modes of transportation 
used by those individuals.
    TSA has a number of options where a person who poses a public 
health threat may attempt to use the commercial airline system. In the 
case of last week's incident, as soon as CDC recognized that the 
individual may have been attempting to fly on a commercial airliner to 
enter the United States against their CDC advice, TSA directly 
contacted the Transportation Security Administration Representatives 
(TSARs) in Europe and International Principal Security Inspectors 
(IPSIs) world-wide to inform carriers, embassies, and host government 
authorities that the infected individual should not board a commercial 
flight. TSA also chose to use the existing infrastructure of its watch 
list system. Given the imminent travel of this infected individual, 
using the existing process was deemed the most expeditious way to alert 
the airlines to prevent the individual from boarding. At no time, 
however, was the infected individual identified as a terrorist. TSA has 
other means at its disposal to communicate threats to airlines 
immediately and direct them to implement specific security measures, 
such as the issuance of a Security Directive.
    The fact that the introduction or spread of a communicable disease 
through the transportation system is not necessarily a threat involving 
criminal violence or other unlawful interference with transportation 
does not preclude TSA from exercising its authority to address such a 
threat. The security of the transportation system involves protection 
of the system from any threat that may disrupt transportation or 
endanger the safety of individuals in transportation. In the case of 
biological threats to the transportation system and its passengers, 
such as the introduction of a communicable disease, it may be 
impossible to determine whether the source of the threat is intentional 
human action, human failure, or a natural occurrence. TSA's authority 
is not limited to dealing only with threats of intentional terrorist 
acts against the transportation system. TSA is charged with assessing 
all threats to transportation and executing such actions that may be 
appropriate to address those threats.

                               conclusion

    In summary, let me restate that DHS will proactively exploit the 
lessons learned from this incident to strengthen our homeland defenses 
and response to infected air travelers. We also look forward to 
streamlining collaboration with HHS/CDC, the Department of State, and 
State and local public health authorities to jointly combat the growth 
of global infectious disease threats, including pandemic influenza. DHS 
apparently had a single point of failure, but that has been corrected 
and has resulted in structural improvements to border security thanks 
to decisive action by CBP leadership.
    We are encouraged that the U.S.-E.U. information sharing of 
Passenger Name Records for public health purposes contributed to CDC's 
efforts to contact travelers who may be at risk for disease 
transmission. We look forward to strengthening U.S.-Canadian 
cooperation and communication on API/PNR and have already reached out 
to continue negotiations. The TSA acted quickly to provide assistance 
to CDC in this case, and has already begun to explore expeditious ways 
of communicating ``pop-up'' threats to commercial air carriers. 
Finally, my office, the Office of Health Affairs, leads the ongoing 
efforts to fulfill the Department's responsibilities for Biodefense, 
including enhanced biosurveillance, and emergency preparedness and 
response, in close coordination with our Federal partners.
    Thank you for the opportunity to present the Department of Homeland 
Security's testimony today. My colleagues and I are available to 
respond to your questions.

    Senator Harkin. Thank you very much, Ms. Spero.
    Now we turn to the questions of, just how sick was Mr. 
Speaker? What is XDR? What's the extent of tuberculosis? What's 
NIH's role in this? What do we have to look forward to in the 
future in regards to tuberculosis and this very virulent strain 
of tuberculosis? That's why we have the Director of our 
National Institute of Allergies and Infectious Diseases at NIH, 
Dr. Anthony Fauci, again no stranger to this committee. Dr. 
Fauci, again please proceed.

STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL 
            INSTITUTE OF ALLERGY AND INFECTIOUS 
            DISEASES, NATIONAL INSTITUTES OF HEALTH, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Dr. Fauci. Thank you very much, Mr. Chairman, members of 
the committee. Thank you for giving me the opportunity to talk 
to you today about the role of the NIH and the National 
Institute of Allergy and Infectious Diseases in the study of 
and providing the basis for the development of countermeasures 
in the form of diagnostics, therapeutics, and vaccines to 
complement the public health issues that Dr. Gerberding spoke 
about vis a vis the CDC.

                     TUBERCULOSIS AND PUBLIC HEALTH

    You might recall, Mr. Chairman, that just 15 days ago I 
showed you this slide at the congressional--excuse me--at the 
Senate hearing that we had on the NIH budget, in which I 
testified on behalf of my institute. You might recall that I 
pointed out to you the constant threat of emerging and 
reemerging infections, not only the obvious new ones like HIV 
and SARS or the reemerging ones like West Nile Virus, but also 
a group of diseases that continue to persist, emerge, and 
reemerge in the form of multiple drug-resistant microbes. Among 
those are staphylococcus, malaria, and also, as we mentioned 
and discussed, tuberculosis, the subject of our hearing here 
today.



    Now, one of the problems with tuberculosis is that we as a 
community of public health officials and scientists have had 
relative success over the years. If you look at the curves of 
tuberculosis in the United States that antedated the HIV 
epidemic, it was almost a straight line coming down because of 
public health measures; there were drugs that were effective. 
It wasn't much resistant, and I'll tell you a bit about a 
vaccine in a moment.
    When the HIV epidemic came, it was really a wakeup call 
that reinforced for us what we already knew, that the vast 
majority of tuberculosis can be well contained by the body's 
immune system, and it generally contains it and it often stays 
in the latent form. We know that one-third of the world's 
population is infected with tuberculosis. They're not sick with 
tuberculosis, but they're infected with tuberculosis.

                               TB AND HIV

    Senator Harkin. Repeat that again, Dr. Fauci? One out of 
every three persons?
    Dr. Fauci. People in the world. Two billion out of 6 
billion people are infected with tuberculosis, the vast, vast 
majority of them in the latent form. There are about 8 million 
cases per year globally of tuberculosis, about 1.6 million 
deaths.
    Now, getting back to HIV, HIV is a good example of what 
happens when the immune system is compromised, in this case by 
the immunosuppression and immunodeficiency of HIV. There are 
some interesting numbers. Of 40 million people living with HIV, 
a third are coinfected with TB. TB is the leading cause of 
death among HIV-infected people worldwide.
    There's an unfortunate relationship between TB and HIV. TB 
accelerates the replication of HIV and on the other hand HIV 
accelerates the progression of TB. So with the vast problem of 
40 million people living with HIV and the overlapping of HIV 
and TB, this is a very serious problem that completely 
antedated the situation that we're talking about here today of 
someone, healthy, young, not HIV infected, who actually gets 
infected--we don't know how; likely through travel and 
exposure--whose disease is latent, but who nonetheless 
manifests the multifaceted way that tuberculosis can present 
itself, either in a latent or in active form.
    So what about the research endeavors, and why do we have 
the challenges that Dr. Gerberding mentioned? We have 
diagnostics that are antiquated. We have not graduated the 
science of tuberculosis into the 21st century. We've done well. 
We've been essentially victims of our success. We've accepted 
diagnostics that are antiquated, insensitive, and slow.
    It would have been wonderful when that patient first went 
to a physician and that culture came back that you could have 
had a point of care molecular diagnosis, A, of TB, and B, of 
whether or not it was sensitive or resistant. We don't have 
that.
    The drug regimens are complex and lengthy, for a number of 
reasons. This is a complex microbe and, as Dr. Gerberding said, 
it grows slowly. Microbes that grow slowly generally need to be 
treated for extended periods of time. That's one of the big 
stumbling blocks with tuberculosis. Under normal circumstances 
it requires 6 to 9 months of therapy. Patients generally feel 
good soon after therapy is started. Often they don't continue 
the therapy--a perfect setup for the development of multiple 
drug-resistant tuberculosis, namely resistant to the first line 
of drugs.
    You can compound that problem when someone comes in with 
multiple drug-resistant TB and it isn't recognized as that and 
you treat them inappropriately. You can then push the spectrum 
to extensively drug-resistant TB, and this is a problem that 
has been emerging over the past several years.
    Vaccine. We've had a vaccine for a century for TB, BCG. It 
has effectiveness in preventing infection like the meningitis 
we see in children. It is considerably ineffective in 
preventing the pulmonary tuberculosis characteristic of 
infections in adults.
    So what are we doing at the NIH? We have the same research 
agenda that we've had in the past, fundamentally basic research 
as our matrix. But we're doing things differently. The 
pharmaceutical companies have been reluctant over the years to 
get involved in the development of countermeasures, for obvious 
reasons. This is not necessarily recognized as an area of 
interest. It has been almost forgotten.
    So we've partnered with the public--excuse me--with the 
private sectors, to make drugs and vaccines. We have now the 
first vaccines in trial in 60 years. It just goes to show you--
a problem that kills 1.6 million people a year and we've had no 
vaccine trials until recently. Now we have 10 vaccines in the 
pipeline, five diagnostics, and 10 new therapies.
    This is a picture of the research agenda which we have been 
working on. We have shared it with our colleagues on the 
outside, inside the NIH, and have received a considerable 
amount of help from our colleagues at the CDC. This morning, we 
have put this live on the NIAID web site. It outlines the six 
basic approaches towards the research agenda: diagnostics, 
therapeutics, basic biology, molecular epidemiology, host 
factors, and prevention, including vaccines.
    So finally we get back again to something that I mentioned 
the last time I testified before you just over 2 weeks ago: 
that the extraordinary capability of many microbes to persist, 
emerge, and reemerge is an inherent part of their molecular 
makeup and their evolutionary capability. How do we balance 
that? We balance that by the public health measures that Dr. 
Gerberding mentioned. We balance that by the development of 
countermeasures in partnership with industry, as well as the 
biomedical research agenda. This is something that we have been 
actively pursuing and will continue to pursue, so that there 
will be medical countermeasures to complement the work that 
you've heard of from Dr. Gerberding.
    I'd be happy to answer any questions, Mr. Chairman.
    Senator Harkin. Dr. Fauci, thank you very much.
    We'll start with questioning. I'll start, then Senator 
Gregg, and then Senator Brown.
    First I'm going to start with Ms. Spero because I think we 
might be able to summarize this very rapidly. The CDC put out 
an alert to you on May the----
    Ms. Spero. The 22d.
    Senator Harkin. May 22. Now, inform us. This goes through 
the systemwide, to all of the inputs, all of the places where 
people would come across the border. But I was told that this 
only identifies someone who uses a passport. Is it not so that 
this person who came across the border from Canada didn't show 
his passport, but only showed a driver's license?
    Ms. Spero. If I could clarify that, Mr. Chairman. CDC did 
not put out an alert. They came to us and asked us to do 
something in our system. They have--we have good relationships 
with CDC in our ports of entry and they came to our Atlanta 
office and they were able to put an alert in a system that we 
use that contains millions of records, that alerts our officers 
to various potentially risky passengers or travelers.
    Senator Harkin. But tell me, when they did that on the 22d 
what was the information given to your border people?
    Ms. Spero. The local people?
    Senator Harkin. Yes. What would have come up on the screen, 
for example? What would it have said?
    Ms. Spero. We actually put in an alert, and what the screen 
said on the alert was: ``If you see this individual''--and then 
subsequently, the next day we put an alert on Sarah Cooksey, 
his fiancee at the time--and it said: ``Place mask on 
subject.'' It said: ``Refer to secondary. Place mask on 
subject. Place in isolation, well-ventilated room if possible. 
Subject has multiple resistant TB, public health risk.'' Then 
it gave the name of the Public Health Service doctor and 
contact him 24 hours, and it gave two telephone numbers for 
him. So the instructions were very clear.
    Senator Harkin. Okay, that's what came up on their screen?
    Ms. Spero. That's correct.
    Senator Harkin. Now, did Mr. Speaker have to use his 
passport or did he just use a driver's license to come across 
the border?
    Ms. Spero. He was not required to, but my understanding of 
the event is that he did show a passport.
    Senator Harkin. But he was not required to?
    Ms. Spero. Correct. If I could take an opportunity, on our 
land border with Canada travelers are not always required to 
show documents. That's the reason that we are so anxious to 
implement the Western Hemisphere Travel Initiative, which will 
make such a requirement mandatory.
    In this particular case, the officer did get I believe both 
passports from Mr. Speaker and Ms. Cooksey.
    Senator Harkin. So he did show his passport, even though he 
didn't have to? If he hadn't shown his passport, then obviously 
nothing would have even come up.
    Ms. Spero. That is the problem. We use a vehicle license 
plate reader, and in this case--but that would not have 
triggered this particular alert.
    Senator Harkin. But the Border Patrol person that was there 
actually saw this information on the screen?
    Ms. Spero. Yes, sir.
    Senator Harkin. Did not follow that?
    Ms. Spero. Correct.
    Senator Harkin. I see. I just wanted to get that clear on 
the record.

                                TIMELINE

    Dr. Gerberding, as I mentioned to you before the hearing, I 
am somewhat perplexed by the fact that on May 17--you've told 
me it was May 18--that CDC was notified by the Fulton County 
officials that Mr. Speaker didn't just have the multiple drug-
resistant strain, but that he had the extremely drug-resistant 
variety. CDC was notified either the 17th or 18th. You can tell 
me what time of the day. I don't know.
    But it wasn't until May 22 that the CDC informed the 
Atlanta office of the Customs and Border Patrol, and then it 
wasn't until the 25th until CDC informed the WHO. My question 
is, what happened on the 19th, the 20th, the 21st, up to the 
22d? What was going on?
    Dr. Gerberding. Let me provide some perspective on that. 
CDC learned on the 18th from the Georgia Health Department that 
the patient may have traveled internationally to Greece. So it 
was not the 17th. It was the 18th. But there have been several 
timelines that have gone through various stages of validation, 
so you may just have gotten information a bit earlier before we 
were actually nailing down the processes. If we have any 
updated timeline information, you'll be getting it. It takes a 
long time to patch these things together.
    But it was the 18th that we learned that this patient, who 
at that time had drug-resistant tuberculosis, MDR TB, was 
likely traveling in Greece. Timeline, current as of June 19, 
2007.






    Senator Harkin. Excuse me for interrupting. I was told that 
you were told that he had XDR.
    Dr. Gerberding. We did not learn about XDR until the 22d. 
That was the day at which the CDC laboratory had the results 
from our own testing of his isolate in our lab, which is really 
the reference lab for the State of Georgia for this kind of 
testing. So we did not know the patient had XDR TB until May 
22.
    Senator Harkin. But you knew he had MDR on the 18th?
    Dr. Gerberding. Correct.
    Senator Harkin. At least had MDR.
    Dr. Gerberding. So let me describe what really was 
happening between the 18th and the 22d because I think that is 
important.
    Senator Harkin. There's a big gap in there.
    Dr. Gerberding. Yes. Let me explain. So if you're in the 
situation of the quarantine officer at CDC, you get a call that 
says there's a patient with tuberculosis, drug-resistant, 
traveling in Greece. That's the first information you have 
about the who and the what it is that we're supposed to be 
doing. So that's the marker to begin a case investigation.
    We can't just call the world and say there's an itinerant 
tuberculosis patient on the loose. We have to first validate 
this. For the sake of all of our citizens, we can't overreact 
when there are issues of civil liberties and personal rights 
engaged. So you have to investigate, and that's what really 
went on for the next couple of days.
    Senator Harkin. Let me clarify something here. I thought we 
knew he was out of the country on the 18th. I hate to get so 
particular on days, but there seem to be gaps of 2 and 3 days 
here where nothing seems to have been done.
    Dr. Gerberding. Let me explain again. On the 18th, this was 
the first official notification to CDC that we had an MDR 
tuberculosis patient that was believed by the county health 
department to be traveling internationally, likely in Greece.
    Senator Harkin. Right.
    Dr. Gerberding. So that was the 18th.
    Senator Harkin. Yes.
    Dr. Gerberding. That was our start time to initiate an 
investigation. We have to go through the whole process of who 
is this, what is his situation, how do we corroborate that he 
has MDR TB, where could he be. We contacted the airlines where 
the health department believed he may have traveled. We were in 
communication with the health department: Please send the 
clinical records, please get the contact information, please 
help us piece together where could he be, why did he go there, 
how can we validate before we take legal measures to interfere 
or we send our counterparts at Homeland Security into action.
    So this is, as you know, part of public health. It requires 
an investigation. We can't just act on presumption. We can't 
act on first indication. We have to get our disease detectives 
to work, dig into this, and figure out what's going on. That's 
what went on.
    One of the confusing aspects of this is that the airlines 
searched their records to determine if the passenger actually 
left Atlanta on Delta Airlines, as he had planned to do to go 
to his wedding. We looked 3 days before that, we looked 3 days 
after that, and Delta had no record that this patient had flown 
out of Atlanta. The reason for that was because the patient 
had, first of all, switched his flight earlier, 2 days after he 
had had the conversation with the health department, and 
second, when he switched he was on Air France, and Delta can't 
see into Air France passenger manifests, a fact that we did not 
know ahead of time.
    So on the 22d when we learned that the patient had XDR TB, 
we felt it was appropriate for us to contact CBP and to try to 
see whether or not our security measures could be engaged to 
help identify the patient as he entered the United States. So 
we in retrospect wish that we had sent all kinds of alerts 
through the travel system on the 18th because that may have 
made a difference, but I think, looking at this as we would 
look forward into the scenario, we would really want to have 
some facts and information together before we took these kinds 
of actions to put a citizen on the terrorism watch list or to 
in any other way interfere with their civil liberties without 
due cause.
    So we were balancing. We've got to find somebody who could 
pose a public health risk, but we also have to be sure we're 
right and that we're being fair to the individual involved.

                        DEGREE OF CONTAGIOUSNESS

    Senator Harkin. Well, again, time. I understand all of 
that, but you did know by the 18th that he had, again he had at 
least MDR? You knew that on the 18th?
    Dr. Gerberding. We were told that he had MDR TB and we 
believed that to be accurate based on other laboratory 
information.
    Senator Harkin. On the 18?
    Dr. Gerberding. Yes.
    Senator Harkin. Well now, it would seem to me that would 
compel you then to activate watch lists immediately so that 
this person is not traveling. But yet you----
    Dr. Gerberding. If we did that we would be putting an awful 
lot of people on watch lists across our country. Again, we have 
to look very carefully. Lots of people have MDR TB. We can't 
put every one of them on a watch list. In this case, we had 
reason to believe that he was traveling internationally, so we 
checked to see, was that true, was he actually traveling 
internationally.
    You know what would happen if you get put on a watch list. 
The next time you would try to go to the airport, you would 
likely have to spend a great deal more time in the security 
line. So these things have to be done in a way that represents 
thorough and comprehensive investigation of all the facts of 
the case before we were prepared to take that step. Now, this 
is part of our after-action. We have to go back and say, well, 
you know, should we be more aggressive about initiating the 
stop in a situation like this and err on the side of isolating 
someone using a Federal order or putting them on a watch list 
before we've done the investigation to be sure that was 
absolutely essential under the circumstance.
    Senator Harkin. Well, I guess I'm a little confused. I 
understand what watch lists are and why you have to be careful. 
But here's a person with a multiple drug-resistant 
tuberculosis. You've identified this person. You knew that he 
may be traveling. Fulton County officials told you that. Are 
you telling me that that's not enough to put someone on a watch 
list? You mean there's a lot of people running around this 
country with MDR tuberculosis that you know about that are 
perfectly capable of getting on airplanes?
    Dr. Gerberding. No, sir, because the vast majority of 
people diagnosed with tuberculosis cooperate with their local 
health officials and don't fly on airplanes. What was different 
about this case is we had a patient who for very compelling 
reasons chose not to follow the advice that was given to him. 
But we have to--it's a balance. We're trying to say we've got 
to protect the public here, we've got to protect the other 
passengers on these planes or the other people at risk. But at 
the same time, we have to respect the fact that an individual 
deserves due process. We have a duty to get the science. We 
have a duty to document the rationale for taking a step that 
really imposes a restriction of civil liberties.
    Senator Harkin. Again, tell us again: How contagious was 
he?
    Dr. Gerberding. Well, contagious at that point in time was 
a question mark. When he was diagnosed, he had tests of his 
respiratory secretions. Those tests grew the bacteria in the 
laboratory. That's how we were able to diagnose the TB and drug 
resistance. But when you took the same specimens and looked at 
them under the microscope, you couldn't actually see the TB 
bacteria. That implies that, while he must have bacteria there 
since the culture was positive, there's not very much of it, or 
we would be able to see it on the sample that we looked at 
under the microscope.
    The term for this is ``smear-negative,'' meaning you've 
smeared some of the respiratory secretions on the slide, it's 
negative for the appearance of the bacteria, but it's culture-
positive. So smear-negative, culture-positive patients 
generally pose a lower hazard of transmission, but it's not 
zero.
    Senator Harkin. What is it?
    Dr. Gerberding. Well, it depends on how long they're in 
contact with someone and what kind of air circulation surrounds 
them.
    Senator Harkin. Say on an airplane that's flying several 
hours?
    Dr. Gerberding. If you were on an airplane with a person 
like this for more than 8 hours and you were seated in two rows 
in front of and two rows in back of that patient, there would 
be an increased risk that you could be exposed. Those are the 
people that we're concentrating our investigation on.
    But a very important point here and one that is coming out 
now in the news, is that the patient is relatively non-
contagious. I hesitate to use any of these terms. If the 
patient is smear-negative, culture-positive, he could transmit 
it to people under certain circumstances, and overall about 17 
percent of the tuberculosis that we see in the United States 
comes from people who are culture-positive and smear-negative. 
So it's not a zero risk. I think that's a very important point.
    Senator Harkin. I'm going to yield. I know other Senators 
want to get involved.
    But it just strikes me as odd that the CDC has at least a 
couple of aircraft capable of transporting Mr. Speaker from 
where he was back to Atlanta and on to Denver, but you say that 
you didn't want to do that because they don't have isolation 
units in the aircraft. But you're telling me that he could get 
on an airplane with 300 and some passengers and maybe only the 
people in two rows in front of him or in back of him are in any 
danger.
    Well, if that's the case then the pilots in a Gulfstream 3 
would not be in danger. He's sitting in the back. They're not 
exposed to him. So the question I have is, why wasn't that CDC 
aircraft used for that purpose?
    Dr. Gerberding. At the time that we were making the 
decisions about flying him, we didn't know how infectious he 
was. The tests that I referred to were done back in March. They 
hadn't been repeated recently in the time where he was 
traveling. So he could have been much more infectious, in which 
case there would be a much greater risk to people on the air 
travel.
    We look at how infectious is he, we look at how bad is this 
organism, and we look at how many vulnerable people are around 
that he could present a hazard to.
    Senator Harkin. I thought you knew that at that time from 
his smear-negative.
    Dr. Gerberding. We knew he was smear-negative in March. But 
his sputum had not been examined recently. So it wasn't until 
he was in Bellevue after he had come home that he had repeated 
tests of his sputum done that showed, thankfully, he was smear-
negative. That's when we used the CDC aircraft to fly him on a 
short trip back to Atlanta.
    Senator Harkin. Then to Denver.
    Dr. Gerberding. Then to Denver. The patient's health 
insurer coordinated the transportation of the patient to Denver 
using their air medical contractor.
    So we had information when we used the CDC plane to tell us 
that he was smear-negative. We didn't have that information 
when he was still in Europe and had been at least 2 months 
without any treatment for his tuberculosis. So in retrospect we 
may have made a different decision, but at the time we really 
had to protect everyone who could be at risk from this deadly 
bug.
    Senator Harkin. I have a couple more, but I've used much 
more time than I should have and I want to yield to other 
Senators.
    I understand we have Mr. Speaker up now. Is that the case? 
Can you hear us, Mr. Speaker?
    Mr. Speaker. Yes, sir, I can.
    Senator Harkin. Fine. I'm glad we got the bugs worked out. 
You'll be on our second panel. We have just finished our 
witness list and now I'm yielding to Senator Gregg for his 
questions.

                        NOTIFICATION PROCEDURES

    Senator Gregg. Thank you, Senator.
    When did you talk to him in Italy, what day? What day did 
you talk to him when he was in Italy?
    Dr. Gerberding. It was about 12:30 a.m., May 23, Rome time, 
so it would be about 6:30 p.m. here on May 22.
    Senator Gregg. Is there a protocol with Italy? Let's say it 
had been an Italian citizen coming to the United States and 
they talked to us. Would there be a--and they'd been talking to 
their citizen in the United States. Is there a protocol that 
either goes through the WHO or that's bilateral, that would 
have allowed you to take action which would have contained his 
movement in Italy, since you had no way to get him back to the 
United States that you were aware of because you had no plane 
available and he shouldn't be traveling commercial?
    Dr. Gerberding. It was the middle of the night when we 
talked to him and we continued conversations with him the next 
morning. We were able to contact a TB expert who had knowledge 
of the chest hospitals in Italy so that we would be able to 
tell him where to go. This individual worked at the ministry of 
health in Italy, but she was also a former CDC employee, so we 
knew how to contact her directly. She actually went to his 
hotel early the next morning to see if she could talk to him in 
person and try to facilitate his medical evaluation and 
determination of his need for isolation. But he had already 
left.
    Senator Gregg. But you're saying that you couldn't--there's 
no authority that you could contact? I mean, an individual 
who's a doctor there is obviously appropriate to refer him to, 
but on the 22d it appears you knew that he was potentially a 
very significant threat to people around him. But there's no 
formal protocol, I take it, with other nations that would allow 
those other countries to call up the head of CDC in Italy and 
say, this person should be contained in some sort of quarantine 
capability?
    Dr. Gerberding. There are international health regulations 
that facilitate this kind of communication and we are in a 
protocol environment where you notify the World Health 
Organization that you have a patient who may present a health 
threat and you can notify the minister of health in the 
affected countries, and CDC initiated that process by 
contacting this minister of health representative in Italy to 
make an assessment of how much further the notification needed 
to go.
    If the patient at that point----
    Senator Gregg. Well, if I can just break in here, doctor, 
because my time is limited, I guess. But the issue is this. You 
knew you couldn't get him back because you knew you didn't have 
a plane that could bring him back and you knew he shouldn't fly 
commercial. Shouldn't there have been the capacity to 
immediately get action in Italy by using Italian authority to 
contain him in Italy, rather than simply have it be--have it 
still be on his goodwill that he not move, since he'd obviously 
shown he was going to move internationally?
    Dr. Gerberding. You're making exactly the point that we 
have learned from this, is that when a patient has demonstrated 
unwillingness to cooperate we cannot give that patient the 
benefit of the doubt any more. We should have initiated----
    Senator Gregg. The second part of that question is, does 
that protocol exist? In other words, do you have the capacity 
to pick up a phone and talk to somebody in Italy or China or 
Japan or other reasonably--or developed nations generally, and 
maybe even undeveloped nations, and get an agreement and an 
immediate action event when you have somebody who you think is 
a risk to their, obviously, their society and to people that 
they're traveling with?
    Dr. Gerberding. Absolutely, and we do this on multiple 
occasions for many other infectious disease circumstances 
frequently. So yes, we call the minister of health, they have a 
TB control office, a very fine program in Italy, and they can 
take the appropriate steps.
    Senator Gregg. But that authority wasn't used?
    Dr. Gerberding. We did not make that authority decision 
initially. We contacted someone from the health ministry. We 
said, assess this; can we find a way to help this patient get 
to isolation in Italy without imposing a law enforcement 
standard around him? The director of communicable disease 
control in Italy was also notified by e-mail.
    We, in retrospect, should have done that. He chose not to 
cooperate with us and we made a mistake in not giving--we gave 
the patient the benefit of the doubt and in retrospect we made 
a mistake. When the patient was contacted in Rome, the patient 
assured CDC that he would not continue to travel until further 
arrangements could be made.

                       INFECTIOUS DISEASE THREATS

    Senator Gregg. I think the almost bigger issue, although 
this issue is obviously significant, especially for people who 
were traveling with him on those airplanes, but the bigger 
issue is the potential threat this represents to world travel 
and to commercial activity and to different countries. I mean, 
this individual chose consciously to move with an infectious 
disease. It's potential that a terrorist might choose to infect 
themselves and move with an infectious disease.
    Is there any capacity at all to deal with that type of a 
situation?
    Dr. Gerberding. Well, certainly there is and in a situation 
of a suspected terrorist we would be able to immediately engage 
law enforcement without anybody questioning the validity of 
that. I think we have to acknowledge that with infectious 
diseases we cannot hermetically seal our borders. We can have 
people moving across borders with infections who are 
asymptomatic. We can have people moving across our borders with 
diseases that don't manifest symptoms that would be picked up 
at our quarantine stations or by our Customs and Border Patrol, 
no matter how well trained they were. Right now we only have 
quarantine officers in 20 airports around the United States and 
we have I think more than 240 crossing areas where people can 
come across our borders.
    So there are--actually, there's 474 ports of entry into the 
United States. We do not have quarantine offices at all 474 
ports, nor will we ever. So if the question is can someone with 
an infectious disease ever make it into the United States and 
pose a health hazard, the answer is absolutely yes.
    Senator Gregg. Obviously this is where Dr. Fauci and his 
team become so important, to try to develop responses to that 
sort of an event. Certainly we've been----
    Dr. Gerberding. I was just notified also by my colleagues 
that actually CDC did contact the minister of health, the 
ministry of health in Italy, on the 24, which is the day after 
the patient contacted us. So we did make an official 
notification to initiate the process that you are describing.

                              NO-FLY LIST

    Senator Gregg. One last question if the chairman will 
indulge me, and that's this. In one of the notes that was given 
us, at 3:35 on May 24 CDC gave DHS Mr. Speaker's information, 
and according to this note the Terrorist Screening Center, 
which administers the no-fly list, determined that Mr. Speaker 
did not qualify for the list because he was not suspected of a 
crime.
    I hope that's not what the decision was. I hope that's not 
the position, because dealing with terrorists you just can't 
wait for the crime. The whole theory that we've supposedly been 
functioning under relative to responding to terrorists is that 
you've got to find them before they commit the crime. This is 
not a post-crime event. It's the big problem we've had with 
changing the culture at some of our law enforcement 
communities, because they're always crime-related, to get them 
to anticipate.
    Is that the policy of the Terrorist Screening Center, that 
if somebody hasn't committed a crime they're not put on the 
watch list?
    Dr. Gerberding. Absolutely not. The patient did get put on 
the watch list. It just required some clarification for a very 
short period of time that day while people verified it, just 
like we at CDC had to verify from our legal counsel that it was 
okay to put someone on the list that involved distributing 
their personal information around the world. But that was a 
matter of a couple of hours, not a matter of days.
    Senator Gregg. But was the initial response from the 
Terrorist Screening Center that they couldn't put him on the 
list because he hadn't committed a crime?
    Dr. Gerberding. The initial response was, let's make sure. 
I think as our agencies have reviewed this we've made it 
crystal-clear that absolutely a person who poses a public 
health threat can be put on that list and we've streamlined the 
process for getting them there.
    Ms. Spero. If I may clarify, that was the responsibility of 
the Transportation Security Administration, another agency 
within the Department of Homeland Security. Technically, I 
think the issue was around the name of the list and the process 
for putting him on the list, not so much the crime aspect, but 
that he was a public health risk at that time, not a terrorist 
risk. So the TSA Administrator used his authority to put--to 
identify him on something that is an adjunct to the watch list.
    Senator Gregg. Does it have the same status as the watch 
list as far as----
    Ms. Spero. Yes, that would be the same process, yes.
    Senator Gregg. Distribution?
    Ms. Spero. Yes, sir.
    Senator Gregg. Thank you.
    Thank you, Mr. Chairman.
    Senator Harkin. Thank you, Senator Gregg.
    Again, I want to make sure that Mr. Speaker is able to hear 
the proceedings. Are you hearing the proceedings, Mr. Speaker?
    Mr. Speaker. Yes, sir, I am.
    Senator Harkin. Very good. Just to set the stage for you, I 
don't know how much you know. You're a little bit at a 
disadvantage. We had hoped to have a visual setup. But we have 
had Dr. Gerberding, the head of the Centers for Disease Control 
and Prevention, and Dr. Anthony Fauci, who's the head of the 
Infectious Disease Institute at NIH, and Ms. Spero, who is 
the--let me get your right title again here--Deputy 
Commissioner of United States Customs and Border Protection.
    So we've had their testimony. We've had some questions from 
both myself, Senator Harkin, and from Senator Gregg, you just 
heard from, from New Hampshire. Now I'm turning to Senator 
Brown from Ohio for his questions.

                   STATEMENT OF SENATOR SHERROD BROWN

    Senator Brown. Thank you, Mr. Chairman. Thank you for the 
courtesy of allowing me to sit in on this.
    Dr. Fauci, thank you. Dr. Gerberding and Dr. Castro, thank 
you for being here and the good work you do.
    I think it's safe to assume that most Americans prior to 
this incident never heard of MDR TB or XDR TB. Most Americans 
think tuberculosis is a disease of the past. As you point out, 
Dr. Fauci, it decidedly isn't. In our country--Dr. Fauci 
pointed out that one-third of people in the world carry the 
bacteria, the tuberculosis bacteria. Some 10 to 15 million 
Americans, it's estimated, carry that. Some 600, 700, 800 
Americans every year most years in the last decade have died of 
tuberculosis. Some 1.6 million people around the world. In the 
country of India I believe about 1,000 people a day die from 
tuberculosis.
    So we know the problem, and I think that we also know that 
tuberculosis is an old, old disease, as old as recorded history 
perhaps. But we need to understand that MDR and XDR TB are 
entirely human-made, that they result from patients with normal 
TB not receiving complete treatment, most often due to weak 
programs, inadequate drug supplies. We have failed to provide 
the basic elements of dealing with that problem.
    I think one lesson from this today from this whole 
unfortunate incident is that XDR TB, MDR TB and XDR TB, is a 
marker of decades of our chronic underinvestment in 
tuberculosis efforts domestically and globally, and this 
doesn't come as a surprise to those of you that have worked on 
this for so many years. Underresourced programs in the United 
States, much of the world, paltry investment in new diagnostic 
drugs and an ineffective vaccine, and recently flat-lining 
domestic control efforts.
    We've been down this road before 15 years ago, a little 
more than that, in the late 80s. The underfunding of TB control 
in the 1970s and 1980s led to a terrible, terrible outbreak of 
drug-resistant TB in New York, as you remember, costing $1 
billion to taxpayers because we hadn't spent the tens and 
hundreds of millions to do what we needed to do for our public 
health infrastructure. I'm hopeful that we learn from that a 
little less expensively this time than that.
    But I think that the point of all of this is if we're going 
to deal with multi-drug-resistant TB, if we're going to deal 
with the even more serious XDR TB, we need to do way better 
with CDC and NIH and public health authorities all over the 
country. I know you already know that and believe that and 
understand that.
    We have introduced, I have introduced with Senator Kennedy 
and Senator Hutchison, our Comprehensive TB Elimination Act, S. 
1551, which will provide, authorize $300 million for domestic--
I understand we spend about a third of that, a little more than 
that--for domestic TB. Senator Boxer has her legislation for 
global TB control.
    But if you, Dr. Fauci and Dr. Gerberding, now that I've 
done my commercial for the bill that we're working on, if you 
would sort of share with us what this funding--what you would 
be able to do which will help to eliminate TB in this country 
and what that would mean in terms of ultimately XDR and MDR TB 
and where we go, if you would.

                               TB CONTROL

    Dr. Gerberding. Let me just start and say thank you. You 
are absolutely right, we are aware of a great deal of media 
interest in this case for obvious reasons. But I wish we had 
had the same degree of media interest the last time we were in 
the Senate testifying on XDR TB.
    We really have a situation in the United States where our 
TB control programs have been receiving the same amount of 
money year after year, at a time when the threat of 
tuberculosis is actually increasing, in part because of the XDR 
and the MDR component. But also that stable funding represents 
a decrease in the States' capacity because the cost of doing TB 
control has obviously gone up in the interim, even if nothing 
else changed.
    So the resources that are being proposed would allow us to 
think of better ways to modernize and streamline our programs. 
It would allow us to do a better job of contact tracing. It 
would allow us to initiate better diagnostic testing. There are 
more modern methods of doing TB testing that we're not able to 
deploy effectively in our health departments today because of 
resource limitations.
    More importantly, I think they would allow us to strengthen 
our activities with international immigrants and refugees who 
come into our country. In the United States, even though we 
have a record low number of TB cases, a greater and greater 
percentage of them are arriving through people who are 
immigrating to our country. So we need to strengthen our 
borders. I think that's a theme of this whole conversation 
today.
    CDC used to have hundreds of people working in its 
quarantine stations at many, many points of entry. During the 
last few years we've been able to increase the number of active 
quarantine stations from 8 to about 20, but we are a long way 
from being able to support our Customs and Border Patrol people 
with the kind of medical support we're going to need in this 
modern world.
    So we appreciate the acceleration and the support through 
the preparedness resources and the homeland security resources. 
But TB is a special focus area and we need to do more. We've 
certainly learned that from this experience.
    Dr. Fauci. In the same vein, Senator, we appreciate greatly 
the effort and the leadership you've shown with your bill. As 
you explicitly say in the language when you talk about the 
kinds of research that is needed, everything from basic biology 
up through and including the development of a vaccine are 
specifically mentioned. As I alluded to in my previous 
comments, it is critically important to get the field of 
tuberculosis into 21st century science, starting off, just as 
Dr. Gerberding said, with the research related to getting what 
would ultimately be a point of care type diagnosis, where you 
can molecularly not only pinpoint the microbe, but by looking 
at its genetic configuration and the expression of its genes 
you'd be able to already tell right from the get-go that you're 
dealing with something that would be predictably multiple, if 
not extensively, drug-resistant. That is critical to the kinds 
of public health measures that the CDC and others are 
responsible for.
    The same holds true for therapies. We really do need 
pipelines. If you look at the drugs that have been developed 
for TB, the last good one was when I was in--when I was in 
medical school. Before I was in medical school was the last one 
that was approved. When you have a disease that's killing 1.6 
million people a year, that's just not good enough.
    Then finally, having relied on a what is generally agreed 
upon as an ineffective vaccine for adult pulmonary 
tuberculosis, we have to use the resources from your bill to be 
able to get a cadre of investigators to get involved with 
industry in developing a vaccine.
    So in summary, we're very greatly appreciative of your 
efforts in that.
    Senator Brown. Thank you.
    As we see us spend $2 billion a week in the war in Iraq and 
give tax cuts to the wealthiest 1 percent of people in this 
country and we see how woefully, this hearing shows how 
woefully we underfund our public health system, I hope we're 
learning something from all of this.
    Thank you.
    Senator Harkin. Thank you, Senator Brown. Thank you for 
your leadership in this area. You're absolutely right, we have 
been underfunding public health for a long time. We've been 
talking about that on this subcommittee for many years. We've 
finally got facilities at CDC, but obviously I think we need to 
do more to beef up our public health system.

                        DRUG RESISTANCE TESTING

    I have about three further questions, Dr. Gerberding, and 
they all revolve around the uneasy feeling that I have that 
between the period of time when CDC was notified by Fulton 
County--and we're going to have Fulton County in the next 
panel, Dr. Katkowsky, I think his name is, who's the head of 
it--I have the uneasy feeling that once CDC was notified he had 
XDR, not MDR, XDR, on May the--CDC was notified on May 18--I 
had 17; you said 18; that's fine--that Fulton County was 
notified he had the XDR strain----
    Dr. Gerberding. No, sir. CDC made the determination of XDR 
TB in our laboratories on the 22d.
    Senator Harkin. When did Fulton County public health 
officials determine he had XDR?
    Dr. Gerberding. They don't have the capacity to do that 
because the State lab doesn't do the extensively drug-resistant 
tests that we're able to do at CDC.
    Senator Harkin. I'm sorry, because I was told that Fulton 
County had notified you on the 20th--I'm sorry, on the 18th, 
that he had the extremely drug-resistant variety. That is not 
the case?
    Dr. Gerberding. That is not the case.
    Senator Harkin. I understand. Then that clears that up. 
Then you then took that--then you over the next few days then 
determined he had the extreme?
    Dr. Gerberding. Let me just explain real quickly how this 
works. When a patient is diagnosed with tuberculosis, a 
clinical lab looks at the specimen and says, yes, there's 
tuberculosis here. Generally the sample goes to the State lab. 
The State lab tests for drug resistance, but it takes a long 
time. When they see signs that it may be drug-resistant, very 
often they communicate with CDC.
    We take the sample to our labs and begin to do the more 
sophisticated tests that can't be done in a regular State lab. 
So our laboratory on the 22 confirmed that the patient had XDR 
TB.
    Senator Harkin. On the 18th you knew that he had MDR.
    Dr. Gerberding. Correct.
    Senator Harkin. I still get the uneasy feeling--excuse me--
that between the 18th and the 22d--I thought it was 5 days; 4 
days--that really not much happened and that there was some 
either confusion or running around in circles or something 
happening at CDC. Sorry to have to say it that way, you know, 
because I don't see----
    Dr. Gerberding. Well, I have to tell you that's not the 
case. There was a very hard-working quarantine officer and his 
teammates who were hour by hour taking a number of steps to 
investigate this. They were trying to locate the patient. They 
were working with the health department and the patient's 
family to try to locate him.
    On the 21st they participated in a very long meeting at the 
health department to try to pull all the data together and 
understand where the patient could be. They were contacting the 
patient's family. They were searching the Internet for 
information: Where were weddings held in Greece, where could 
the patient possibly be? They were on a detective hunt to try 
to figure out, did he leave the country, is he in Georgia, did 
he go someplace else, did he elope, where was this patient and 
what was his status?

                     NOTIFICATION RESPONSIBILITIES

    Senator Harkin. When did you or when did the people at CDC 
know that his father-in-law was at CDC and was in fact a TB 
researcher? When was that known to you?
    Dr. Gerberding. Well, I didn't know about it until after 
the patient was on his way home. Dr. Castro here is the 
supervisor of our tuberculosis division at CDC and he probably 
knew that earlier, and I can verify with him. But the important 
question is when did the quarantine officer who was in charge 
of this investigation know, and he did not know that early on 
in the course. We can find out for you exactly when that 
information became known to the person who was conducting this 
investigation.
    Senator Harkin. Would it be too much to assume that Dr. 
Cooksey, I believe his name is, had knowledge that Mr. Speaker 
had MDR, at least MDR, at the time that Mr. Speaker traveled 
out of the country?
    Dr. Gerberding. I believe that would be correct, based on 
what I've heard. I can't validate that because I haven't asked 
Mr. Cooksey that question. But based on his participation in 
family discussions on the 10th, he is likely to know that 
information. I think the health officer can validate that he 
was completely informed of that.
    Now, if he knew that independent of his participation as a 
family member and when he knew that, I would have to go back 
and check.
    Senator Harkin. Well, I guess the question--I don't have 
Dr. Cooksey in front of the panel here, but we may reach out to 
ask him this question--is, again I ask you, what is the 
responsibility of someone like that, who is a researcher, who 
knows what MDR is, and does he have a responsibility to notify 
CDC of this situation?
    Dr. Gerberding. You know, this is exactly why we are 
conducting the internal review and exactly why we've asked the 
inspector general to assist us, because here's a man who's got 
two compelling responsibilities, the responsibility as a health 
professional and a CDC employee and his responsibility as a 
family member and a father of the bride. How that conflict or 
potential conflict was adjudicated is something that we need to 
carefully review, and I believe the best way to do that is not 
only through our internal mechanisms, but also to be sure that 
we have an objective perspective from the inspector general. So 
we agree that that needs to be assessed.

                                PLANNING

    Senator Harkin. I appreciate that.
    Last again, the idea of planning. As you have pointed out, 
most of your experience has been with patients who are 
compliant. But obviously, I would think once in a while people 
pop up who won't be compliant, for one reason or another. Have 
you had, CDC at any time in the past run any kind of trials, 
tests, to test the system? Say that someone popped up who was 
noncompliant and began to travel with some virulent infectious 
disease. Had those kind of tests been run before through your 
operation?
    Dr. Gerberding. Absolutely. We just in the context of 
pandemic influenza, have been exercising both around tabletops 
with media as well as around actual functional exercises at 
CDC. One of the key areas in these exercises is quarantine and 
isolation authorities, how can they be utilized in the context 
of a pandemic.
    The issue in the pandemic that's come up, however, for us 
is again that keeping people out part of quarantine and 
isolation. We have not yet exercised what about a U.S. traveler 
with pandemic flu who chooses to travel internationally and how 
we would go about fixing that. But we will be exercising 
exactly on that point imminently, because obviously we have 
learned that.
    I think where we would like to focus our exercise attention 
in this context is with the World Health Organization and the 
countries. The international health regulations are due to be 
enforced beginning June 15. They're wonderful regulations, but 
there's no operational planning around them, and this is going 
to be the perfect case study for us to sit down with the 
affected health ministries and the TB officials at WHO and say: 
Great ideas, but how are we going to create operational and 
tactical plans?
    Every country's going to have to come to grips with the 
same things CDC did: How do we keep people from going, how do 
we find out where they are, how do we handle them when we need 
to isolate them in someone else's country, and who pays?
    Senator Harkin. I appreciate that. But again, I repeat for 
emphasis sake that on the 18th you were notified that he had 
multiple drug-resistant TB. Border Patrol was not notified 
until May 22. He was not placed on the no-fly list until 2 full 
days later on May 24. Again, with the rapidity of world travel 
today, it seems to me that this timeframe should have been 
collapsed to just a few hours.
    Dr. Gerberding. Senator Harkin, in retrospect I would 
absolutely have acted much earlier. But when we were looking at 
it through the prospectoscope we really felt we needed to get 
the science and the evidence and the clinical information 
together before we took those steps. I think we can do that 
faster. I think we should have done it faster and I think we'll 
be able to accelerate this next time.
    In retrospect, that was a mistake and I wish we had done it 
differently.
    Senator Harkin. So you can assure us that through your 
internal reviews at CDC that you are going to take a look at 
this, what happened, and to take steps necessary to ensure that 
in terms of a noncompliant individual in the future that you 
can assure us that you will put programs in place, procedures 
in place, to collapse a time frame like that?
    Dr. Gerberding. Senator, I have to say that this makes me 
sad. I have always had good relationships with my patients and 
I admit that perhaps I am too optimistic about what people will 
do. But in this situation we should have recognized that if the 
person left against medical advice in the first place that by 
definition means he's unlikely to be cooperative there on in, 
and that should be an indicator to take more aggressive action.
    Our systemic issue here is constantly giving the patient 
the benefit of the doubt and failing to use the most aggressive 
measures earlier in the process. I don't know what that will 
mean the next time there is a person who would cooperate 
because we don't want to go so far in the opposite direction 
that we're punitively restricting movement of people 
unnecessarily. This balance is going to be very tough, and I 
think the best way to handle it is to try to learn our lessons 
as we go forward, but also to be transparent about the 
decisions that we're making when we're making them and what we 
learn in the process. I appreciate that you've given me so much 
time today to be able to try to present the larger context 
here.
    Senator Harkin. I appreciate that, and we thank you all, 
and we'll move on to our next panel. I just want to let you 
know that we will be looking at--we, I say ``we'' collectively, 
Senators and this subcommittee and others, I'm sure, taking a 
look at--any legal things that we need to have changed here to 
provide a legal structure for CDC to be able to do this. We 
look forward to working with you on looking at that legal 
structure, what needs to be changed.
    Dr. Gerberding. Thank you. That would be very helpful. 
Thank you.
    Senator Harkin. We'll do that. Thank you very much, Dr. 
Gerberding. Dr. Fauci, Ms. Spero, thank you very much.
    Now we'll move to our second panel. On our second panel we 
have Mr. Andrew Speaker, an attorney with the Speaker Law Firm 
of Atlanta, Georgia. Obviously, I don't think I need to say 
anything more than that. He is obviously the person who, the 
focus of this hearing today, not so much he himself, but the 
circumstances surrounding this and the possible threat to 
public health, as we just heard from our first panel.
    Then we have Dr. Steven Katkowsky, the Director of the 
Department of Health and Wellness at the Fulton County, 
Georgia, Department of Health.
    Then we have Mr.--Dr. Nils Daulaire, the President and CEO 
of the Global Health Council. Prior to assuming this position, 
Dr. Daulaire was the Deputy Assistant Administrator for Policy, 
as well as Senior International Health Adviser, at USAID.
    So we have Dr. Katkowsky here and of course Dr. Daulaire, 
and on the phone we have Mr. Andrew Speaker. Mr. Speaker, I 
know you're at somewhat of a disadvantage because you're not 
here today. I had hoped to, as I said, have set up a visual 
connection, but somehow that couldn't get done with the 
National Jewish Hospital in Denver. I'm sorry that you missed 
most of the first panelists' testimony. I think you heard some 
of our questioning.
    But again, Mr. Speaker--and you obviously did not hear my 
opening statement, but for your information this subcommittee 
is the committee that basically funds NIH and the Centers for 
Disease Control and other institutions of health. And we have 
been instrumental in the past few years in providing funding 
for CDC in Atlanta--of course, you're from Atlanta; you're well 
aware of that--and for the NIH in strengthening our public 
health system here in America.
    There is great concern, Mr. Speaker, about your movements 
abroad, leaving this country, going abroad and coming back, and 
that--and perhaps exposing others to a very extreme form of the 
TB bacteria, I guess I would say. It's not a virus; a bacteria.
    Again, I want you to know we all sympathize with your 
situation and the fact that you do have this, and we pray for 
your recovery and we hope that the good people at National 
Jewish will be able to treat you adequately and get you through 
this period of time and get you back to a state of good health. 
You are at one of the best facilities in the world for that 
right now.
    So I just want you to know that you are not without some 
sympathy and understanding on the part of this subcommittee. 
However, we do have another responsibility and that is to the 
public and to the public health. Again, that's why we are 
concerned about the procedures, processes, laws, things that we 
need to do to protect public health in the future. So I hope 
you understand that.
    With that, I would just turn it over to you for any 
statement that you might have to this subcommittee, and if you 
would then be responsive to any questions the subcommittee 
might have. So Mr. Speaker, again welcome, at least 
telephonically, and again you have our best wishes for a full 
and fast recovery.

STATEMENT OF ANDREW SPEAKER, SPEAKER LAW FIRM, ATLANTA, 
            GEORGIA
    Mr. Speaker. Thank you, sir.
    First of all, as you know, I'm here at your leisure. 
Anything you care to ask me, please feel free. I'm going to try 
and--unfortunately, I didn't hear everything. A few of the 
points that were made I'm going to try and go over, because I 
know Ms. Gerberding just said that it made her sad and the 
covenant of trust, but a few of the things you were told are 
simply not accurate.
    She mentioned that there was a test in March was the last 
smear-negative test I had. I actually--since January when this 
came out, I have fully cooperated with everything anyone has 
asked me to do, whether it's taking a test, an MRI, an X-ray, 
anything along the way. When it was finally verified that I had 
TB, I believe it was early to mid-April, Fulton County called 
me up and asked me to come down. I cleared my schedule that 
afternoon, went down, got another smear test, which turned up 
negative, got more blood work.
    Actually on that day--I'm sorry I don't have the exact 
date--but I spoke with an official from the CDC, conveyed my 
plans about the wedding. They did know about this. This wasn't 
something hidden. This was something that was out in the open, 
that numerous officials of the CDC, at the county level, my 
doctors, everyone knew about.
    I started treatment at that point. CDC started doing--and 
cut me off at any time. I'm just going to speak.
    Senator Harkin. Go ahead.
    Mr. Speaker. CDC at that time--I had a bronchoscopy and 
they started doing cultures. So when I had the much-discussed 
meeting on May 10th, at that point on May 10 CDC was aware of 
my travel plans. While it may not have been communicated up the 
chain of command, that's not something I'm really privy to. But 
I do know that not just my father-in-law, but numerous people 
at CDC knew of the travel plans. It was CDC who was doing the 
testing, who helped come back with the fact that I had MDR TB. 
That was by the date of May 10. I'm not sure how far in advance 
they knew that, but I know at that meeting on May 10 I was made 
aware.
    Right now there's this--I understand people's utter fear 
with this because they hear on the news and on TV that with the 
TB, even if I'm smear-negative, I'm not highly contagious, but 
there's still a chance. I hope that you and the committee 
understand that when I sat there on May 10 with MDR TB it was 
my father, my father-in-law, my bride to be, my doctor, and the 
health official; none of us were wearing masks.
    I was repeatedly told that I was not contagious, not that I 
was partly contagious, but that I was not contagious, that I 
was not a threat to anyone. I was walking around, doing my job. 
As far as I knew from my medical advice--and I don't think 
anyone's going to get up in front of you today and tell you 
otherwise--I was clearly told I was not contagious. They were 
letting me walk around and go about my business.
    So I look to the people who I believe I should trust to 
tell me whether or not I'm a threat to those around me, and 
they told me I wasn't. No one ever told me I was a threat to my 
wife or my daughter. If they had of, obviously if I got to that 
meeting and they said, you have MDR TB, either my father-in-law 
would have said, you've got to be careful and stay away from my 
daughter and my granddaughter because you could get them sick, 
my dad would not have let me be around my mother. I just myself 
wouldn't have been around my wife or my daughter and taken that 
risk that I could give them this. I don't want this and I 
wouldn't have wanted to give it to somebody else.
    But as I said, CDC knew that I had it. They were aware that 
I was going on my travels. Yes, I was told that Fulton County 
would prefer I not travel, but I was also told I was not 
contagious. I was told I was not a threat to anyone. I was told 
there was no need to sequester me. With that information--I'm 
sitting here in quarantine and isolation, and yet I'm still 
smear-negative.
    So maybe they should have told me before, but that's--I'm 
not a doctor. They should have told me 2 weeks ago: Look, 
you're a threat to your family and those around you; get out to 
Denver. But at that meeting we knew it would take 2 to 3 weeks 
to find out what type of, I believe it's MIC, it's my minimum 
resistance, what my--which drugs I was susceptible to. It would 
take a few weeks to get a bed in Denver. As long as I'm walking 
around and I'm not a threat to anyone, why not go on my 
honeymoon for the next 2 to 3 weeks instead of just sitting at 
work and going to court and doing everything else?
    Senator Harkin. Well, Mr. Speaker, again this is 
information again I wish I'd had prior to Dr. Gerberding 
leaving. She had to leave to go over to the House side. But I 
intend to call her back now, or at least I will keep her on the 
record on this.
    You are saying that on May 10 that you were in a meeting 
with people from both the Fulton County, but there were people 
there from CDC? You're certain of that?
    Mr. Speaker. What I'm saying, sir, is that--and by default, 
yes, my father-in-law was there, but he was not acting in a CDC 
capacity. CDC was doing resistance testing and was 
communicating that to Fulton County, who I had the meeting 
with. So they were aware of the drug resistance. CDC had my 
culture and they were doing the resistance testing on it, which 
they helped pass on to Fulton County. So they knew that I was 
MDR on the 10, and they knew that I was traveling. They knew I 
was traveling because I told that to the CDC official when I 
went to Fulton County weeks before this.
    Senator Harkin. See, Mr. Speaker, what I have learned is--
two questions here. I was told earlier, and I went at length on 
this, that the Fulton County officials--and we have Dr. 
Katkowsky here and we'll ask him about that--that CDC was 
notified on May 18 that you had an MDR strain. It is your 
contention that CDC actually knew about this before that?
    Mr. Speaker. There were conversations back and forth 
between my doctors, the doctors out here in Denver, CDC, Fulton 
County. They were all discussing this because of the fact that 
there was resistance, and to set up and talking about getting 
me out to Denver. All this was being discussed before that 
meeting on the 10th and that's how they knew they would take 
weeks to find out exactly what was left that I was susceptible 
to. The CDC was doing those drug resistance tests. So to say 
that they didn't know when they're the ones who were coming up 
with the resistance is ridiculous.
    Senator Harkin. So before this meeting on May 10, you had 
already been in conversations with your doctors and with health 
officials and with people out at National Jewish Hospital?
    Mr. Speaker. Yes, sir, because the meeting on the 10th was 
called because I was already on--they had asked me to go on 
your standard, their standard four drugs they treat TB with. I 
had been on them for a few weeks, and they called the meeting 
because they said: Look, you're resistant to these, so we need 
to go--we might as well take you off of them because they're 
not doing any good and let's talk about your treatment plan and 
what drugs are left. That was the purpose of the meeting, to 
talk about what my future treatment would be, because they knew 
that I was resistant and now we need to figure out the next 
step. That next step was trying to get a bed in Denver and 
figuring out what my resistance would be.
    But I'm still--mind you, I'm still walking around this 
whole time, going to court, and no one has said a single word 
to me, including at that meeting, that I am a threat to anyone. 
I want people to understand that I'm not walking around knowing 
that I have TB and not seeking treatment. I am following all 
the guidelines of treatment that my doctors are telling me at 
that time. I was on medication, and they're the ones who took 
me off because they knew it wasn't doing any good.
    Senator Harkin. I see. Now, one last thing I think you 
mentioned that I picked up I made a note on and I want to make 
sure that I'm correct on this. Did you say you contacted CDC in 
April or did your doctor contact CDC?
    Mr. Speaker. Sir, well, Fulton County--my doctors as part 
of protocol contacted Fulton County and let them know that I 
had TB. So Fulton County called me and I went down to Fulton 
County and met with a CDC official who was working with Fulton 
County and who interviewed me. I told him about my wedding 
plans. I told him about my travel plans. At that time my health 
provider had already put me on the standard four-drug regimen a 
few days before.
    So they took another sputum test at that time, which was 
some time I think early mid-April, which came back negative. 
They said, okay, continue your treatment, because when I was 
speaking to Fulton County at that time we didn't know it was 
resistant, and you get your treatment every 30 days and that 30 
days would have elapsed while I was in Europe. So I told them 
that they needed to give me an extra 30 days before I left so I 
didn't run out while I was in Europe on my honeymoon, so I 
could keep taking my medication. This was before, you know, 
they took me off of it because I was resistant.
    So to claim that--everyone knew I was going. I didn't go 
running off or hide from people. It's a complete fallacy and 
it's a lie.
    Senator Harkin. Well, Mr. Speaker, this is interesting 
news. We have Dr. Katkowsky here and we'll go over with him 
about the Fulton County. We'll move ahead on that right now. 
Please stay on the line. I will come back to you, but I want 
you to hear their testimony, Dr. Katkowsky and Dr. Daulaire, 
and we'll be back to you. So stay on the line with us.
    Now we'll turn to Dr. Katkowsky, director of the Department 
of Health and Wellness at Fulton County, Georgia, Department of 
Health. Dr. Katkowsky, welcome to the committee and please go 
ahead and proceed and fill us in on the circumstances as you 
know them.

STATEMENT OF STEVEN KATKOWSKY, M.D., DIRECTOR, 
            DEPARTMENT OF HEALTH AND WELLNESS, FULTON 
            COUNTY, GEORGIA
    Dr. Katkowsky. Good morning and thank you, Chairman Harkin. 
I appreciate the opportunity to appear before you today.
    Senator Harkin. Would you pull the mike in a little bit 
closer to you there, Dr. Katkowsky.
    Dr. Katkowsky. Is that better?
    Senator Harkin. That's fine, thank you.
    Dr. Katkowsky. I was just thanking you for the opportunity 
to appear here today.
    Specifically, lots of things that have been discussed both 
by the first panel session and just now by Mr. Speaker leave 
some question as to perhaps the time line and what everybody 
remembers as the time line and what everybody remembers as the 
time line for what happened, what didn't happen, what might 
have been communicated.
    Mr. Speaker was correct, he was referred to the Fulton 
County Health Department on April 23 because of a positive 
culture for TB. He was seen in our department on April 25 in 
our TB clinic. The physician that saw Mr. Speaker was also a 
CDC physician who is an expert in TB. He was not working as a 
representative of the CDC. He was working for the Department of 
Health and Wellness in Fulton County. So there really are a 
couple of parallels.
    Senator Harkin. So he was not a CDC employee, or was he?
    Dr. Katkowsky. He was a CDC employee, but he was working at 
a local health department in a TB clinic. I think perhaps 
that's where some of the question arises as to what did CDC 
know and when did they know it. I think the greater question is 
what did they know, when did they know it, and from whom did 
they know it.
    Yes, Mr. Speaker was put on the standard regimen of drugs, 
and with subsequent testing, yes, he was smear-negative, as Dr. 
Gerberding said. But he remained culture-positive.
    Now, the local health department does not have the means to 
be able to do the kind of specialized tests to determine, 
number one, resistance to the strain of TB; number two, the 
degree of resistance to a strain of TB. Our initial TB tests 
are conducted by the State public health laboratory. As Dr. 
Gerberding said, the CDC has the laboratory ability to then 
test for sensitivity, resistance, and so on to the different 
standard anti-TB drugs.
    This strain of TB proved to be resistant. In a meeting with 
Mr. Speaker, with his physicians and some family members, that 
took place on May 10, he was informed officially that he had 
MDR, or multi-drug-resistant, TB. That in and of itself from a 
health perspective is cause for concern. The cause for concern 
is brought about because drug-resistant tuberculosis to any 
degree is much more difficult to treat. The treatment itself 
takes longer.
    The recommendation was made, as Mr. Speaker says, to seek 
treatment in Denver, Colorado, at a specialty facility. So a 
lot of these things are coming together, but the juxtaposition 
of them I think really requires further explanation.
    Upon making his status known to him, the other piece of 
information that was transmitted was: No, you should not 
travel. The question that's been asked over and over again, was 
Mr. Speaker prohibited from traveling, was he ordered not to 
travel, and the answer to that was no. The local health 
department does not have the authority to prohibit or order 
somebody not to travel. In Georgia our role is to be able to go 
to the courts to seek an order to compel either treatment, 
isolation, or restriction on travel.
    We had consulted with the Fulton County attorney's office 
and asked them what action might be available. Unfortunately, 
as you've heard before this morning, the way a lot of the laws 
are written is action can't be taken until a violation has 
occurred. In other words, we can't be proactive. I can't look 
at somebody and say they might rob a bank. I have to wait until 
they rob a bank to then be able to take the necessary legal 
action.
    Well, in this case, as Mr. Speaker clearly points out, he 
did not refuse treatment. He did not refuse to be tested. He 
had also not violated the medical directive to not travel. So 
we found ourselves in a catch-22 where the law provides for 
action to be taken after there's a violation, but not before in 
a preemptive way that would have allowed us to be able to 
prepare.
    One of the questions that I know the committee has asked 
this morning was what could have been done or would have been 
done differently. I think had the local health department been 
in a position where the laws would have allowed the department 
to be anticipatory rather than reactionary--and by that I mean 
we could have, had the law allowed, issued a request to the 
courts, have an isolation order or have a restriction on travel 
order issued, and then have an immediate or within 72 hours a 
hearing for the patient to be able to come forward, present 
their information, and then have the court decide whether or 
not that order needs to remain in effect, while balancing the 
patient's rights with the rights of the rest of the population.
    One of the things that was a great concern, and as a public 
health official I must tell you the thing that was a great 
concern, was Mr. Speaker's health, his well-being, the 
treatment he would and could receive, as well as the health and 
well-being of the population.
    Senator Harkin. Well, Dr. Katkowsky, again Mr. Speaker--I 
took my notes here--that on May 10 he said everyone was aware 
of his travel plans, he had not hidden them, that CDC was 
present, I assume in this person that you spoke about, this 
physician that is at your Fulton County health facility, he was 
made aware of the MDR TB, but no one, he said, was wearing 
masks. He was told that he was not contagious. He was not told 
to avoid people.
    You heard what Mr. Speaker said. So in that framework, it 
would seem to me that the average person would say, well, okay, 
I have this thing, but if I'm not contagious and all these 
people around me, they know about my travel plans, but no one 
said that he shouldn't do this. He was told he was not 
contagious.
    Is that your recollection?
    Dr. Katkowsky. No, sir. First of all, I was not in the 
meeting, but the patient's chart indicates that he was told he 
was not highly contagious. As Dr. Gerberding pointed out 
earlier, that somebody who is smear-negative but culture-
positive is still able to transmit tuberculosis. As a matter of 
fact, about 17 percent of all the cases that we see are 
transmitted by people who are smear-negative.
    The other piece of information is that, yes, we knew of his 
plans to travel; the plan that we knew of was for Mr. Speaker 
to travel outside the United States on May 14. We then, in this 
case incorrectly, assumed that we had at least 4 days to be 
able to work up a plan, be able to put plans in place, and that 
would have included referral to Denver, Colorado.
    Yet what we found out was Mr. Speaker moved up his travel 
date, was not available, could not be reached, and the whole 
question of whether or not we could have compliance at that 
point and was it safe for him to travel could not even be 
addressed because at that time he was out of the country.
    Senator Harkin. I'm going to get back to Mr. Speaker on 
this. He is still listening. Before I do, I'm going to go to 
Dr. Daulaire, though. Dr. Daulaire--``Doe-LARE,'' I'm sorry; I 
mispronounced that--President and CEO of Global Health Council.
    Dr. Daulaire, welcome to the committee. Please give us the 
benefit of your insight into this.

STATEMENT OF NILS DAULAIRE, M.D., M.P.H., PRESIDENT AND 
            CHIEF EXECUTIVE OFFICER, GLOBAL HEALTH 
            COUNCIL
    Dr. Daulaire. Thank you very much, Mr. Chairman.
    Senator Harkin. Pull that mike in a little bit.
    Dr. Daulaire. Right. I would request that my full written 
statement be submitted for the record.
    Let me just change the frame here for a moment if I can. 
We've been talking about, if you will--it's summertime--a 
swimmer and a single wave, and perhaps a failure at a life 
guard station. What I'd like to talk about is the ocean because 
there are a lot more waves where this one came from and a tide 
that's coming in.
    Frankly, as long as the tide of global infectious diseases 
broadly and MDR and XDR TB in particular continue to rise, 
quarantine and border controls will never adequately protect 
Americans. So I think it's very important to recognize that we 
need to look outside our borders as well as at our border 
protections if we're going to be fully addressing these issues.
    Now, the Global Health Council, the organization I lead, 
represents health professionals and service organizations 
working in more than 100 countries. We know this issue up close 
and personal and I've dealt with it for three decades myself. 
We recognize, as Dr. Fauci said, that one-third of humans on 
the face of the Earth, 2 billion or more people, are already 
infected with the TB bacillus, that 8 million of them will 
become sick with TB this year, and that somewhere between 1.6 
and 2 million will die this year.
    But what I think we are at risk of neglecting is the fact 
that this is really a moving train. Eight years ago the global 
health community raised an alarm about the growing threat of 
multi-drug-resistant TB. It was new on the horizon at that 
point, and the fact that there were now outbreaks of cases 
around the world, again 8 years ago in 1999, that indicated 
that there were now a growing number of TB cases that did not 
respond to first-line drugs, was a cause of real concern.
    Today we're dealing with extensively drug-resistant TB and 
the estimate today is that there are somewhere in the vicinity 
of half a million MDR TB cases in the world and that about 10 
percent of those, about 50,000 of them, are XDR TB cases. So 
50,000 people just like Mr. Speaker around the world that pose 
a public health risk to all of us.
    What I want to make sure we address today and going into 
the future is that 8 years from now that we're not having a 
hearing that talks about TDR, totally drug-resistant TB, 
because that's the next step along this chain unless we get 
control of the situation globally, not just at our borders and 
within the United States.
    Now, I have enormous sympathy for Mr. Speaker and the 
condition that he's under because, frankly, as a physician 
myself I would sooner have a diagnosis of cancer than a 
diagnosis of XDR TB. The cure rate for XDR TB is under 30 
percent at this point and fewer than 50 percent of people with 
XDR TB in active cases survive 5 years. So it's a very 
dangerous situation to be in. On top of that, someone with 
cancer isn't at risk of spreading it to other people, as people 
with TB are.
    This is certainly a national security issue and I'm glad 
that this committee has raised that as a concern. But it's not 
about terrorists or the idea of people voluntarily infecting 
themselves. We have literally millions of people around the 
world crossing borders every day. Many of them are infected, 
whether it's with TB in one of these variants or other 
infectious diseases. What we need to do is to recognize that 
unless we address the problems of these diseases, particularly 
TB but others as well, at their source, which is in the world's 
poor communities around the world, that no walls that we can 
build can possibly be high enough to protect the American 
population.
    That's the nature of today's world and the best guess right 
now is that Mr. Speaker himself contracted his XDR TB traveling 
in Peru or possibly in Vietnam. So we are a Nation of travelers 
and we're a Nation of immigrants, and we are not an island in 
the world. In a globalized world, all of us, rich countries and 
poor countries alike, paddle in the same microbial sea.
    So what we need to recognize is that most XDR and MDR TB 
cases are unknown, unrecognized. It's just by chance that Mr. 
Speaker's was identified when he had his rib injury and got X-
rayed. And we probably have dozens, possibly hundreds, of 
people traveling internationally on airplanes every day who 
have infections that could be at risk for other people.
    We need to get into the communities where this is spreading 
rapidly and institute good controls. Now, it's not principally 
about a technological fix. Yes, new drugs that will treat TB 
more quickly or that will work against MDR and XDR TB are 
very--going to be very important tools, and new vaccines, as 
Dr. Fauci talked about, that work effectively for adult 
pulmonary TB are very important. But right now we have the 
opportunity to go and to work with countries around the world 
in terms of their TB control programs in their own communities.
    XDR and MDR TB are results of failures of basic TB control 
programs. There's examples of successes. Indonesia and the 
Philippines have done good programs and in fact China as well 
have greatly reduced the emergence of new and more dangerous 
forms. So this is very doable.
    I would congratulate the Senate on the introduction of two 
bills, one domestic and one international, for addressing TB. 
Senator Brown's leadership on this issue has been really 
laudatory and it goes back to his time in the House of 
Representatives.
    But the CDC has had, as Dr. Gerberding said, flat-line 
funding for the last 10 years. It's a real decrease in terms of 
actual programs on the ground. Local health departments are 
hurting. The investments that are being carried out by----
    Senator Harkin. The time. There's two votes on the floor.

                           PREPARED STATEMENT

    Dr. Daulaire. I'll wrap up.
    The investments carried out by NIH are dwarfed by the 
investments of one single foundation, the Gates Foundation. I 
think the United States Government needs to do more to protect 
our citizens, our children, and our grandchildren.
    Thank you.
    Senator Harkin. Thank you very much, Mr. Daulaire.
    [The statement follows:]

                Prepared Statement of Dr. Nils Daulaire

    Chairman Harkin, ranking member Specter and members of the 
subcommittee, thank you for inviting me to testify before you today on 
``Cracks in the System--An Examination of One Tuberculosis Patient's 
International Public Health Threat.'' I am Dr. Nils Daulaire, President 
and CEO of the Global Health Council, the world's largest membership 
alliance of health professionals and service organizations working to 
save lives and improve health throughout the world.
    Before I begin my remarks, let me thank you, Chairman Harkin, for 
your leadership not only on domestic health issues, but also 
recognizing that the health of our brothers and sisters around the 
world is also of priority. Your commitment to shoring up bioterrorism 
resources and capabilities has reinforced the link between health and 
national security. Senator Specter, your commitment on HIV/AIDS is much 
appreciated as this disease continues to wreak havoc on communities 
around the globe. On behalf of the Council's 350 member organizations 
working in over 100 countries across the globe, and the millions whose 
lives are improved by U.S. Government investments, we thank you.
    The Global Health Council's members include non-profit 
organizations, schools of public health and medicine, research 
institutions, associations, foundations, businesses and concerned 
global citizens who work in global health--delivering programs, 
building capacity, developing new tools and technologies and evaluating 
impact to improve health among the poor of the developing world. Our 
members work in a wide array of areas, including child and maternal 
health, family planning, HIV/AIDS, other infectious diseases, water and 
sanitation, primary health care and health systems strengthening. The 
members of the Council share a commitment to alleviating the great 
health disparities that affect the world's most vulnerable people. The 
Council serves its members and the broader community of global health 
stakeholders by making sure they have the information and resources 
they need to fulfill this commitment and by serving as their collective 
voice.
    It has been my privilege to be part of the global health movement 
for over 30 years, and much of my career has been spent as a physician 
and program manager in some of the world's poorest countries--most of 
them places where TB is widespread and where control is challenging. 
Working in countries such as Nepal, Mali and Haiti, I have had the good 
fortune to participate in the development and front-line delivery of a 
number of important basic health interventions. I have also had the 
honor of serving in government as a senior policy advisor in USAID. My 
remarks today derive from these different perspectives and experiences, 
as well as the evidence and experience of the Council's membership.
    No matter how informed or how prepared we think we are, like many 
of you, I was caught off guard by last week's news of an individual--an 
American, no less--who traveled around the world and back with a highly 
dangerous form of tuberculosis. As we have seen in the media and heard 
from public officials, there were a number of missed opportunities 
along this man's itinerary that could have caused serious harm to 
others. We dodged a bullet on this one. It appears that the impact of 
this one man's travel will be minimal. But, the question of ``What 
if?'' certainly lingers. What if this happens again? What if the 
patient is more contagious next time? How can we ensure that we protect 
those both in this country and around the world from a deadly 
infection? This is a fundamental tenet of public health.
    Please realize that every lesson we need to learn about prevention 
and protecting the public's health is present in the current story of 
this American traveler. This was an educated man--a lawyer. His 
immediate family works at the world's leading public health prevention 
agency--education and awareness should have been no issue. He accessed 
the medical system and consulted with providers. Yet, somehow, we sit 
before you today describing a ``crack,'' as the hearing's title 
implies, in the system. As this case could certainly be considered one 
of national security, let me assure you, there is no border control 
possible that will stop infectious diseases from entering our country. 
We must address infectious health threats at their origin as well as 
our borders and across our States.
    Tuberculosis (TB) represents the classic public health challenge. 
It is a communicable disease, perpetuated by and reinforcing poverty in 
resource-poor settings; it spreads due to crowded conditions and poor 
sanitation. TB taxes and, through its spread, exposes weaknesses in 
every part of the health system from surveillance to labs and from 
diagnostics to the health workers that ensure that the established 
treatment strategy is appropriately delivered. In short, TB is a 
snapshot of the broader health system and global health portfolio, 
what's working and what is not.
    There was a time when TB was a major public health challenge in the 
United States, but with the advent of then-effective medicines in the 
1940s, rates began to decline and TB became an uncommon disease in this 
country. We all remember the TB test of our school days, carried out by 
a simple pinprick on our forearms as a part of our scheduled medical 
check-ups. This vigilance was a sign that the health system respected 
the potential threat of this airborne bacteria and the importance of 
preventing its spread by promptly identifying and then treating those 
who had been infected. However, in the 1970s and 80s, the country let 
its guard down by decreasing investments in basic TB control programs. 
As a result, TB rates began to rise.
    Although TB is no longer considered to be a major public health 
threat in the United States, it still infected almost 14,000 people in 
2006. This is only a fraction of the global TB burden which is 
characterized by nearly 9 million new active cases each year and 2 
million deaths. Eighty percent of active TB cases are concentrated in 
only 22 countries; an epidemic dominated in the prison populations 
throughout eastern Europe, in overcrowded villages and slums in Asia 
and among HIV-positive individuals throughout sub-Saharan Africa.
    There has been progress. China is an example of an exemplary 
success story in TB control. In 1991, China launched a 10 year effort 
to reduce TB in 13 of its 31 provinces. The strategy was to implement 
the DOTS strategy (directly observed therapy short-course) using 
village doctors with basic training as the primary provider involved in 
surveillance, diagnosis and treatment. The village doctors referred 
suspected cases to dispensaries where diagnosis could be done and the 
followed up with treatment. The outcomes were: treating 1.5 million 
people, eliminating 836,000 cases of pulmonary TB, a 95 percent cure 
rate for new cases, a 90 percent cure rate among unsuccessfully treated 
previous cases, a 37 percent decline in the number of people with TB 
and preventing 30,000 TB cases per year. The costs were $130 million 
total with each successful treatment costing less than $100/person. The 
program has had a very high rate of economic return. This effort 
represents classic public health, a basic health systems approach--
absolutely necessary and yet perpetually underfunded.
    As you know, TB is a disease caused by the Mycobacterium 
tuberculosis bacteria. The infection usually attacks the lungs and 
manifests as weakness and fatigue, chills, loss of appetite and bad 
coughing fits. Two billion people--one-third of the global population--
are infected with TB. For most, it will remain latent, a silent 
hitchhiker, causing no symptoms and not a risk for infecting others. 
However, 1 in 10 will eventually manifest the disease. TB is diagnosed 
using a blood or tuberculin skin test or, in the developing world, an 
old fashioned sputum smear and examination under a microscope--a 
technology employed in the 1880s and still used today. Two lines of 
drug treatment currently exist for TB. These treatments are most often 
delivered via the DOTS strategy--Directly Observed Therapy short-
course. Of course, ``short course'' in TB means 6 to 9 months of 
carefully monitored treatment with multiple drugs. So, while it is 
relatively inexpensive--$20 or so in drug costs over the full course--
it requires perseverance and good management on the part of the health 
system.
    As with other communicable vectors, TB is a smart bug. Over time, 
given the opportunity caused by breaks in treatment, it grows resistant 
to available drugs, requiring the use of second-line drugs and longer 
treatment regimens. At this point, one experiences multi-drug resistant 
(MDR) TB. This resistance is expedited when TB patients prematurely 
halt their treatment course, mistaking feeling better for having rid 
themselves of the infection itself. The frightening news of late has 
been the emergence of the extensively resistant form of TB (XDR-TB) 
that responds to neither first- nor second-line drugs. In fact, 
treatment options are incredibly limited and what is available is 
expensive, costing in excess of $7,000 and running a treatment course 
upward of 24 months. This assumes, however, that patients are 
diagnosed, are able to access treatment and don't succumb almost 
immediately to XDR-TB as many have in South Africa.
    Dr. Gerberding has shared the current epidemiological update of MDR 
and extensively-drug resistant (XDR) TB. I will only reinforce her 
summary to say that the current situation with MDR-TB and, most 
recently XDR-TB, demonstrates clearly that our global public health 
infrastructure is not working. XDR-TB is a 100 percent man-made 
phenomenon, resulting from unsustained investments in basic public 
health.
    The 2006 news out of KwaZulu Natal teaches us important lessons. 
First, the impact of infectious disease can be rapid--too rapid for an 
unprepared health system. Of the 53 individuals first identified to be 
infected, 52 died--in an average of 16 days. There is a real human 
element to this. Health systems, through their workers, must be in 
touch with their patients. They must communicate and ensure that 
patients are seeking appropriate treatment. Second, our intelligence is 
only as good as our intelligence gathering systems. Africa has 25 major 
laboratories that are able to detect drug resistance; 19 of those labs 
are located in South Africa. So, we, in truth, have no idea of the 
extent of the XDR situation throughout Africa or other parts of the 
world. We only know about South Africa because that is where the 
capacity exists. Finally, even once we identified XDR-TB, we had no way 
to adequately treat it, demonstrating that research and development of 
new drugs and program delivery must run on parallel tracks with 
simultaneous investment.
    Allow me to share this analogy with you to stress the importance 
and potential impact of the current TB situation. Our cars have 
dashboards with a series of icons that light up when something in the 
car's system needs attention. So, when the ``check engine'' light comes 
on, we know we need to tend to the engine before a larger systems 
failure occurs. We should consider the current TB situation to be a 
blinking light on the dashboard of our public health system. Something 
is wrong. Something is not working. It needs attention or we will, no 
doubt, experience larger systems failures that will cost not only 
money, but perhaps millions of lives over time.
    I encourage the committee to direct its attention to the current 
threat of MDR and XDR-TB. But, I caution you to not just focus on just 
this single disease as it does not occur in isolation, particularly in 
the developing world. I further caution you look beyond the immediate 
situation--one that has been brewing for some time now, but was just 
recently brought to mainstream attention by the recent news story out 
of Atlanta. You'll recall West Nile Virus a few years back. With that 
threat, the government generously supplemented Federal, State, and 
local health budgets with resources for the virus. Since 1999, we have 
spent well over $100 million for a disease that took fewer than 1,000 
lives total. Yet, the health system grew no more prepared to respond to 
future threats and other public health priorities starved, continuing 
to cost health and lives.
    Instead of attempting to tend to the Nation's health one issue--no, 
one emergency--at a time, I hope I can persuade you to take a 
comprehensive systems approach to support public health here and in the 
world's poorest countries so that if, and in the case of an increasing 
number of infectious diseases, when these situations occur we have the 
surveillance systems that recognize them early, we have the laboratory 
capacity to accurately diagnose, we have a healthy technology pipeline 
that makes diagnostic tools and treatments available quickly and 
consistently, the health workforce to deliver the interventions and 
manage the programs and the monitoring and evaluation systems to know 
how we've done and how we can do better. Like our car engine, these 
pieces need to work together: a system. U.S. investments in a 
sustainable response, in cooperation with the World Health Organization 
and its developing capacity to share information on global health 
events quickly and with clear guidance to member states, will benefit 
everyone no matter where they live or travel.
    I also encourage the committee to recognize that today we are 
discussing TB. Tomorrow it will be something else. That is nature of 
health in a globalized and interconnected world. I cannot overstress 
the need to think comprehensively and long-term.
    The MDR and XDR-TB situation before us is serious. However, the 
good news for TB is three-fold. First, it does occur in the United 
States and not only overseas, making it difficult for our policymakers 
and program managers to ignore. As a result, State and local public 
health departments include TB in their portfolios and are largely able 
to identify the disease and respond. Second, TB shares center stage 
along with AIDS and malaria as one of the most visible public health 
challenges facing the world today. Undoubtedly, the last decade has 
represented a period of unprecedented and unparalleled attention and 
resource mobilization for the overall global health agenda, with much 
of the attention concentrated in AIDS and, more recently, malaria. 
Because of the close links, TB shares in that attention and those 
resources and hopefully comparable investments specific to TB are soon 
to follow. And, finally, although we need to shore up the technology 
pipeline by investing in research and development for new tools and 
treatments, we can make great progress with what we currently have 
available. Basic TB control demonstrates what is possible when provided 
attention and resources.
    Mr. Chairman, there are three immediate steps Congress can take to 
address the threat of MDR and XDR-TB:
    1. Continue and enhance funding for basic global health programming 
through the Centers for Disease Control and Prevention, for global 
health research at the National Institutes for Health and technical 
guidance through the U.S. Agency for International Development (USAID) 
so that no one is left to fight this evolving disease without prompt 
diagnosis, effective medications and treatment support. Domestic and 
global TB investments have stagnated over recent years, threatening a 
repeat of what we experienced in the 1970s and 80s when we assumed that 
declining incidence rates meant that investments could decline as well. 
Let us recognize and support the very good work of the CDC and the NIH 
that provide the leadership and content for our domestic and global 
health efforts. Level funding of bilateral programs and proposed cuts 
to contributions to the Global Fund to Fight AIDS, TB and Malaria in 
the coming fiscal year simply will not stand. A reduction in 
investments will cost us lives.
    2. Legislatively, there are a number of bills that address both the 
TB situation and broader systems issues. Support for the Comprehensive 
TB Elimination Act of 2007 and the Stop TB Act of 2007 is needed now. 
In addition, support for innovative financing and incentivizing private 
industry engagement through market activities outlined in the Vaccines 
for the New Millennium Act is also warranted. Finally, the global 
health community urges you to support the African Health Capacity 
Investment Act to assist countries in sub-Saharan Africa--a region 
where some countries have as few as 20 health care professionals per 
100,000 people--in the efforts to achieve internationally recognized 
goals in the treatment and prevention of HIV/AIDS and other major 
diseases, including TB, by improving human health care capacity and 
improving retention of medical health professionals in sub-Saharan 
Africa. It must be noted, however, that the health care worker shortage 
is global and not just confined to sub-Saharan Africa. A comprehensive 
response to this issue is needed.
    3. Support the public health investments needed to make sure the 
United States is fully integrated into the global surveillance and 
events management and response systems being developed at the WHO as 
the International Health Regulations go into effect this summer. In 
addition to making sure our national monitoring and response system is 
in place, as my colleagues have elaborated, the Global Health Council's 
perspective is that the health of the world knows no borders. We cannot 
protect the health of the American people in isolation, but only by 
sharing information, resources and a transparent emergency response 
system with all other countries.
    Yes, tuberculosis is a disease of the poor and, often, the 
uneducated. However, this case dispels every possible stigma one could 
attach to this disease. It proves that a global outbreak is just a 
flight away and it may--as our traveler did--make a pit-stop in Greece, 
Prague, Italy, and Canada--covering the world in a week. If it could 
happen to this gentleman, it could happen to anyone. Let us not treat 
just this individual situation or this individual because he is an 
American. Recognize what this case represents. The solutions are not 
just in this room. They are at local levels. Yes, the Fulton County 
Health Department, but also the district level in Southeast Asia where 
it appears he may have contracted the initial infection.
    We cannot resolve the TB situation ``here'' without resolving it 
``there.'' When it comes to health, there is no ``them,'' only ``us.'' 
Fixing' the cracks, if that is possible, requires a global solution at 
the level of basic public health systems in the poorest parts of the 
world.

    Senator Harkin. Mr. Speaker, there's two votes on the 
Senate floor that I have to go tend to right now, so I have to 
adjourn the hearing. I just have a couple of questions. Do you 
have any idea where you contracted this TB?
    Mr. Speaker. Well, sir, there's two options. I was in 
Vietnam with the Rotary Club last year and we went around to 
orphanages and hospitals helping out for about 5 weeks, and it 
could have been there. Or it could have been, I was in Peru 
about 6 years ago and it could have been at that point.
    Senator Harkin. I see. Well, you're unfortunate in that 
you've got it. It was again a fortunate circumstance where you 
had this rib problem and got in and got diagnosed, as I 
understand it, at an early stage.
    I'm not trying--it's not my intent here to get into a he-
said-she-said type of situation between you and Fulton County 
and Dr. Gerberding. But what I am trying to do is to ferret out 
just how this process worked, what happened, what was the 
misinformation, so that we don't have this same kind of thing 
occurring again.
    One last question I have for you, Mr. Speaker, is why did 
you move up your date from May 14 to May 12?
    Mr. Speaker. Well, you've got to understand at that time I 
was trying to change jobs. My family, a lot of my family had 
already gone over. I was just told that I was going to have my 
right upper lung taken out likely, that I was going to have 2 
years of treatment where I'd have daily IV injections, if not 
every other day. So I wasn't going to go anywhere for probably 
the next 2 years because I'd have to have officials coming up 
for the IVs every day.
    My wife was busy with--she was in law school and she had a 
trial clinic on the weekend. I wasn't sleeping. My wife said: 
Look, honey, everybody's going over. I had already taken her 
parents to leave over there. She said: Why don't you just go on 
over; you know, once you get over there you're not going to be 
worried about things, you're not going to be stressed about 
things, and when we come back we'll worry about it then.
    Again, why should I be worried if Fulton County never 
addressed it head-on, or at least I didn't hear it. But I was 
clearly told word for word I was not contagious and I was not a 
threat to anyone, that there was no need for me to be 
sequestered when I got out to Denver, because I wasn't 
contagious.
    I just hope that's--and there are some other--I hope we do 
get to address it again because I really would love the 
opportunity to discuss what happened in Rome. I think there's 
an impression that we just fled, but when we talked to the CDC 
we immediately ended our trip. We were supposed to head to 
Florence on a train the next morning. They told us cancel, we 
need you to cancel your trip; we're going to call you tomorrow 
with your travel arrangements. We immediately cancelled our 
trip, got another night in our hotel, didn't get on the train, 
and said, okay, if that's so then it's time to go home.
    The next day they called us and--I mean, we called them 
later that next night, and that's when they told us: We've 
looked at all the options, we've been in meetings all morning, 
we're not comfortable putting you on a plane and we're not--
there's no funding. I don't know where this stuff about the 
health risk on the plane came from. That was never mentioned to 
us. It was just told that the CDC doesn't have any funding to 
put private individuals on planes. You know, there's $7 million 
to have them sit there a year, but nothing to actually use 
them.
    So I was told that the only option--that my father had been 
called earlier that day and told that he, and her father had 
been called earlier that day, and they had both been told the 
only option was for them to raise the money and get me home. 
And I was told that if I didn't come up with, their estimates 
were up to $140,000, to get myself home, I would have to stay 
there and be treated.
    I had been told before I left that the people in Atlanta 
couldn't handle this, this was above their heads with the 
surgery and treatment. If I didn't get to Denver--you know, I 
wasn't dying. I was walking around. I felt great. But when it 
came time to treat it, if they didn't use exactly the right 
drugs, if I lost any more drugs, I would lose my chance.
    So they asked me to voluntarily check myself in, that the 
authorities were coming in the morning, and I could be stuck 
there indefinitely in the Italian hospital. I came home, 
because again I asked them, what's changed? When I left I was 
noncontagious and I wasn't a threat to anyone, and what's 
changed? Why are you leaving me here? I just wanted to get 
home.
    I'm sorry for all the stress I've caused people, but I hope 
they understand where I was. I hope it changes the policy and I 
hope the way they handle things changes.
    Senator Harkin. Mr. Speaker, thank you. I believe that's 
hopefully the benefit of this hearing and what we found out, 
that we are going to change some procedures. I have real 
questions also about the aircraft and why it was not just sent 
over. The CDC uses its aircraft to fly Secretary Leavitt around 
from city to city all over the United States. You're telling me 
it couldn't have gone over to pick up a highly contagious--
well, not highly contagious; he wasn't highly contagious. 
That's the wrong choice of words. But to pick up an individual 
that they knew about, to bring them back here.
    I just don't understand that the CDC couldn't have done 
that. Now, they said, well, the aircraft didn't have an 
isolation unit. Well, then there's a matter of how many hours. 
Well, you flew from New York to Atlanta, Atlanta to Denver, on 
the CDC plane. That's at least 3 hours, 4 or 5, maybe 5 or 6 
hours total there. I've got to believe from Rome to New York to 
Atlanta probably on a G3 probably wouldn't be much over 8 hours 
total flight time. The patient's health insurer coordinated the 
transportation of the patient to Denver using their air medical 
contractor. The CDC airplane was not utilized to transport the 
patient to Denver.
    So I'm thinking that this answer I've heard does not hold a 
lot of water. It looks like there was some bureaucratic 
mismanagement here. But that's again what we want to get at. We 
want procedures and processes in place, plans done ahead, so 
that incidents like this can be handled expeditiously in the 
best interests of both the patient, the individual, but also 
the public at large. That's where this thing just fell apart.
    Again, I intend to have CDC back up here again to go 
through this again with them and to make sure that we have--we 
put these processes in place.
    So I think, Mr. Speaker, again you have our hopes and our 
prayers for a full recovery. I hope that you will again 
continue to let us, our committee, be in touch with you as we 
move ahead on this. We may have further questions as this thing 
moves ahead. But I think you've enlightened us greatly with 
your testimony here this morning.
    I thank Dr. Katkowsky also. As I said, I'm not trying to 
get into who said what and that type of thing. We have plenty 
of documentations on the timeframes and what was said and that 
type of thing. But better just to get at this and get it fixed 
so that we can assure the public that this won't happen again. 
That's really what we want to try to do.
    So again, Mr. Speaker, our hopes for a full recovery. 
Again, this committee through our staff may be in touch with 
you, I hope, at some time in the future, if that will be okay 
with you.
    Mr. Speaker. I'm here at your leisure, sir.
    Senator Harkin. Well, thank you very much. We know about 
National Jewish. It is one of the finest institutions in the 
world for respiratory illnesses. You are at the best place in 
the world right now. I know of that. I can assure you of that. 
I've been out to National Jewish myself.
    Mr. Speaker. Yes, sir.
    Senator Harkin. So you have the best facilities and the 
best doctors out there.
    Thank you again, Mr. Speaker and Dr. Katkowsky, Dr. 
Daulaire.

                         CONCLUSION OF HEARING

    Thank you very much for being here.
    [Whereupon, at 12:11 p.m., Wednesday, June 6, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair].

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