[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]







                  GLOBAL CHALLENGES IN DIAGNOSING AND
                    MANAGING LYME DISEASE--CLOSING 
                             KNOWLEDGE GAPS

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

                                HEARING

                               BEFORE THE

                 SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,
                            AND HUMAN RIGHTS

                                 OF THE

                      COMMITTEE ON FOREIGN AFFAIRS
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 17, 2012

                               __________

                           Serial No. 112-169

                               __________

        Printed for the use of the Committee on Foreign Affairs




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                      COMMITTEE ON FOREIGN AFFAIRS

                 ILEANA ROS-LEHTINEN, Florida, Chairman
CHRISTOPHER H. SMITH, New Jersey     HOWARD L. BERMAN, California
DAN BURTON, Indiana                  GARY L. ACKERMAN, New York
ELTON GALLEGLY, California           ENI F.H. FALEOMAVAEGA, American 
DANA ROHRABACHER, California             Samoa
DONALD A. MANZULLO, Illinois         BRAD SHERMAN, California
EDWARD R. ROYCE, California          ELIOT L. ENGEL, New York
STEVE CHABOT, Ohio                   GREGORY W. MEEKS, New York
RON PAUL, Texas                      RUSS CARNAHAN, Missouri
MIKE PENCE, Indiana                  ALBIO SIRES, New Jersey
JOE WILSON, South Carolina           GERALD E. CONNOLLY, Virginia
CONNIE MACK, Florida                 THEODORE E. DEUTCH, Florida
JEFF FORTENBERRY, Nebraska           DENNIS CARDOZA, California
MICHAEL T. McCAUL, Texas             BEN CHANDLER, Kentucky
TED POE, Texas                       BRIAN HIGGINS, New York
GUS M. BILIRAKIS, Florida            ALLYSON SCHWARTZ, Pennsylvania
JEAN SCHMIDT, Ohio                   CHRISTOPHER S. MURPHY, Connecticut
BILL JOHNSON, Ohio                   FREDERICA WILSON, Florida
DAVID RIVERA, Florida                KAREN BASS, California
MIKE KELLY, Pennsylvania             WILLIAM KEATING, Massachusetts
TIM GRIFFIN, Arkansas                DAVID CICILLINE, Rhode Island
TOM MARINO, Pennsylvania             
JEFF DUNCAN, South Carolina          
ANN MARIE BUERKLE, New York
RENEE ELLMERS, North Carolina
ROBERT TURNER, New York
                   Yleem D.S. Poblete, Staff Director
             Richard J. Kessler, Democratic Staff Director
                                 ------                                

        Subcommittee on Africa, Global Health, and Human Rights

               CHRISTOPHER H. SMITH, New Jersey, Chairman
JEFF FORTENBERRY, Nebraska           KAREN BASS, California
TOM MARINO, Pennsylvania             RUSS CARNAHAN, Missouri
ANN MARIE BUERKLE, New York          THEODORE E. DEUTCH, Florida
ROBERT TURNER, New York              
                                     







                            C O N T E N T S

                              ----------                              
                                                                   Page

                               WITNESSES

Stephen W. Barthold, Ph.D., distinguished professor, Department 
  of Pathology, Microbiology and Immunology, Center of 
  Comparative Medicine, School of Veterinary Medicine, University 
  of California, Davis...........................................     8
Raphael Stricker, M.D., vice president, International Lyme and 
  Associated Diseases Society....................................    24
Mark Eshoo, Ph.D., director, New Technology Development, Abbott..    46
Ms. Patricia Smith, president, Lyme Disease Association..........    54
Mr. Evan White, Lyme disease patient.............................    76
Ms. Stella Huyshe-Shires, chair, Lyme Disease Action.............    83

          LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING

Stephen W. Barthold, Ph.D.: Prepared statement...................    10
Raphael Stricker, M.D.: Prepared statement.......................    26
Mark Eshoo, Ph.D.: Prepared statement............................    49
Ms. Patricia Smith: Prepared statement...........................    57
Mr. Evan White: Prepared statement...............................    79
Ms. Stella Huyshe-Shires, chair, Lyme Disease Action.............    86

                                APPENDIX

Hearing notice...................................................   104
Hearing minutes..................................................   105
The Honorable Christopher H. Smith, a Representative in Congress 
  from the State of New Jersey, and chairman, Subcommittee on 
  Africa, Global Health, and Human Rights: Statement from the 
  Infectious Diseases Soceity of America.........................   106

 
                  GLOBAL CHALLENGES IN DIAGNOSING AND
                     MANAGING LYME DISEASE--CLOSING
                             KNOWLEDGE GAPS

                              ----------                              


                         TUESDAY, JULY 17, 2012

              House of Representatives,    
         Subcommittee on Africa, Global Health,    
                                  and Human Rights,
                              Committee on Foreign Affairs,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:07 p.m., in 
room 2172, Rayburn House Office Building, Hon. Christopher H. 
Smith (chairman of the subcommittee) presiding.
    Mr. Smith of New Jersey. The hearing will come to order. 
Good afternoon, and welcome to our witnesses and to everyone 
who is joining us for this first ever congressional hearing 
examining the global challenges in diagnosing, treating, and 
managing Lyme disease.
    My personal commitment to combating Lyme disease is 
longstanding, going back 20 years, when one of our witnesses, 
Pat Smith, attended one of my town hall meetings in Wall 
Township, New Jersey, and asked me to get involved. I did. On 
September 28, 1993, I offered an amendment to establish a Lyme 
disease program through the Environmental Hygiene Agency of the 
U.S. Department of the Army. It passed and became law.
    On May 5, 1998, I introduced a comprehensive, bipartisan 
Lyme disease bill, H.R. 3795, the Lyme Disease Initiative Act 
of 1998, which had at its core the establishment of a task 
force, an advisory committee to comprehensively investigate 
Lyme with at least four major areas in mind: Protection, 
improved surveillance and reporting, accurate diagnosis, and 
physician knowledge. I reintroduced the bill again in 1999, 
2001, 2004, 2005, 2007, 2009, and have a pending bill that I 
introduced in 2011.
    I would note parenthetically that in 1998 I also introduced 
a comprehensive law to combat autism despite significant 
opposition in the Congress and at NIH and CDC that closely 
paralleled the Lyme bill's struggle. That became law in 2000. 
Last year, I authored the Combating Autism Reauthorization Act 
of 2011, which was signed into law in the fall with the support 
of--not opposition, but the support of NIH and CDC. If only we 
had done the same with Lyme disease legislation in the late 
1990s; there has been a missed decade on Lyme.
    As I have met scores of patients suffering the devastating 
effects of chronic Lyme who only got well after aggressive 
treatment by Lyme-literate physicians, I have been dismayed 
and, frankly, angered by the unwillingness of some to take a 
fresh, comprehensive look at this insidious disease. My current 
bill, H.R. 2557, simply establishes a Tick-Borne Disease 
Advisory Committee, like we have been trying to do since 1998, 
with the requirement of ensuring diversity of valid scientific 
opinion, a ``broad spectrum of viewpoints'' to pull language 
out of the legislation, serving on the committee.
    I would note to my colleagues that in Europe, Lyme disease 
syndromes were described as early as 1883, and by the mid-
1930s, neurologic manifestations and the association with ticks 
were recognized. In the United States, Lyme disease was not 
recognized until the early 1970s, when a statistically 
improbable cluster of pediatric arthritis occurred in the 
region around Lyme, Connecticut. This outbreak was investigated 
by Dr. Allen Steere and others from Yale and stimulated intense 
clinical and epidemiologic research. In 1981, Dr. Willy 
Burgdorfer, an NIH researcher at the Rocky Mountain 
Laboratories, identified the spiral-shaped bacteria, or 
spirochetes, causing Lyme disease and made the connection to 
the deer or black-legged tick.
    Lyme disease is the most common vector-borne illness in the 
United States and is also endemic in parts of Europe and Asia 
and recently has been confirmed to be endemic in the Amazon 
region of Brazil. In Europe, the highest rates are in Eastern 
and Central Europe. Recent surveillance studies have described 
growing problems in Australia and Canada.
    In the United States, Lyme disease has been reported in 49 
States--all except Hawaii--and is most common in the 
northeastern and north-central States and in northern 
California into Oregon. Over 30,000 confirmed cases were 
reported to the CDC in 2010, making it the sixth most common 
reportable disease in the U.S. and the second most reportable 
in the Northeast. CDC has estimated that actual new cases may 
be 10 times more than the reported number, indicating roughly 
300,000 cases in 2010 alone. About 85,000 cases are reported 
annually in Europe as of 2006, according to the WHO, but that 
was recognized as a gross underestimate.
    In North America, the only Borrelia species to cause Lyme 
disease is Borrelia burgdorferi. In Europe, Borrelia 
burgdorferi and at least four other species cause the disease. 
Different species are associated with different manifestations 
of the disease. There are numerous strains of Borrelia, which 
may affect the ability to evade the immune system, the ability 
to invade certain organs or tissues, and the response to 
antibiotics. Clinical manifestations of Lyme are usually 
divided into three stages, although the descriptions of the 
stages vary.
    Few diseases have aroused such a high level of emotion and 
controversy among the public, physicians, and researchers than 
Lyme disease. There are two distinct views of Lyme disease, 
each citing specific scientific evidence to support its claims, 
while outcomes research is limited and conflicting.
    One view, promoted by the Infectious Disease Society of 
America, is that the disease is ``hard to catch and easy to 
cure'' and denies the existence of chronic Lyme disease or 
persistent infection with the Lyme bacteria. Any treatment 
other than a short course of antibiotics is considered too 
risky. Patients who do not fit the paradigm may have few 
options outside of psychiatric evaluation.
    The alternative view, promoted by the International Lyme 
and Associated Disease Society and also by numerous academic 
researchers in the U.S. and around the globe, says that the 
science is too unsettled to be definitive, and there could be 
one or more causes of persistent symptoms after initial 
treatment in an individual who has been inflicted with the 
agent of Lyme disease. These causes include the possibility of 
persistent infection or postinfectious process or a combination 
of both.
    These are not academic concerns, however, because the 
patient's health is at risk. Unfortunately, some academic 
researchers believe that some of their colleagues are more 
interested in winning arguments than moving the science 
forward. Three areas central to the controversy are: The 
quality of diagnostics, post-treatment, and available treatment 
options in light of clinical guidelines.
    Current diagnostic tests commonly used to detect the 
spirochetes that cause Lyme disease rather than detect whether 
the patient has developed antibodies to these pathogen, CDC 
recommends a two-tier serological testing but cautions that the 
two-tier system could be used only for surveillance purposes 
and not for diagnosis. Part of the difficulty in clinically 
managing suspected Lyme disease is that the CDC protocol is 
frequently not only used but required for diagnosis.
    A study in the Netherlands of eight commercially available 
ELISAs and five immunoblots found that they had widely 
divergent sensitivity and specificity and a very poor 
concordance and concluded that their ``very high variable 
sensitivity and specificity further puts the much-advocated 
two-tier testing strategy into question.'' In addition, two of 
the authors of the July 3, 2007, article on an antibiotic 
resistance element were Julie Boylan and Frank Gherardini of 
NIAID's Rocky Mountain Laboratories. And they stated, ``It is a 
multistage disorder that is difficult to diagnose at any stage 
of the disease, as well as being difficult to treat during the 
later symptoms.''
    Dr. Mark Eshoo, the head of new technology at the IBIS 
Biosciences Division of Abbott Laboratories, will tell us today 
some exciting information regarding the development of 
diagnostic tools that hopefully will move us past a lot of the 
controversy.
    Then there is the issue of persistence. IDSA has repeatedly 
stated that there is no convincing evidence that the Lyme 
Borrelia persists after standard antibiotic treatment. 
``Convincing'' is clearly a subjective term, however. There is 
substantial evidence of the persistence of it after treatment 
with antibiotics. There are numerous documented case studies of 
persistence in humans after antibody treatment, and our 
witnesses may comment on additional evidence for post-treatment 
persistence in humans.
    Additionally, one of our speakers today, Dr. Stephen 
Barthold, one of the top experts in the country, and I am sure 
in the world, on animal models--Dr. Barthold will describe 
published and yet-to-be-published experimental studies that 
provide compelling evidence for the Borrelia burgdorferi 
persistence following an antibiotic treatment in animal model 
studies and their potential significance for human medicine.
    Numerous studies have been conducted of the mechanism by 
which Borrelia may evade the immune system and antibiotics. 
Studies have suggested that resistance to antibiotics might be 
due to formation of different morphological forms of it, 
including cell wall deficient forms and biofilm-like colonies.
    Contrary to the known scientific evidence, in a March 21, 
2008, letter to Members of Congress, the Infectious Disease 
Society of America stated, ``Not only is this assertion [that 
the notion that some spirochetes can persist despite 
conventional treatment courses] microbiologically implausible, 
there are no convincing published scientific data supporting 
the existence of chronic Lyme disease.'' It is problematic that 
the Infectious Disease Society of America would write to 
Congress trying to discourage support of legislation, saying 
that post-treatment persistence is microbiologically 
implausible.
    Additionally, in an article, ``A Chronic Appraisal of 
`Chronic Lyme Disease','' published in 2007 in the New England 
Journal of Medicine, several IDSA physicians and a CDC 
colleague made the statement that ``chronic Lyme disease''--and 
this is a quote--``which is equated with chronic B. burgdorferi 
infection is a misnomer.'' While this statement has been 
referred to repeatedly in other correspondence, calling chronic 
Lyme a misnomer does not seem reasonable or supportable since 
it goes far past expressing uncertainty. It seems clear that 
the intent of the statement was to firmly slam the door on the 
notion that there possibly could be chronic Lyme.
    The final major area of controversy is the significance of 
the Infectious Disease Society of America's treatment 
guidelines, which directly impact patients and their ability to 
get treatment. Guidelines should be developed based on the best 
science, and there has been extreme controversy regarding the 
restrictive nature of the IDSA guidelines. The guidelines do 
not allow for the possibility of chronic infection and severely 
limit physician discretion on treating the disease.
    Finally--and I would ask unanimous consent that my full 
statement be made a part of the record--I would point out to my 
colleagues that we did invite the Infectious Disease Society of 
America to be here, the NIH, as well as the Centers for Disease 
Control. We were told that the IDSA person who would have been 
here had a ``scheduling conflict.'' And I would just make very 
clear at the outset of this hearing that I will reissue an 
invitation to them and fully expect that they will testify 
before our subcommittee at a date that will hopefully be very, 
very soon.
    I would like to now yield to Ms. Bass for any opening 
comments she might have.
    Ms. Bass. Thank you, Mr. Chair. I want to thank you for 
holding this hearing on Lyme disease.
    And I also want to thank today's witnesses in research 
advocacy and other efforts to bring greater clarity to the 
nature of this disease. Your work has been critical to 
understanding the disease's continued emergence and what 
measures are needed to prevent new infections and treat those 
who are infected.
    Mr. Chairman, I also want to commend you for your 
leadership on this issue. And, as you have noted, Lyme disease 
continues to infect and affect a great number of North 
Americans, including our own citizens. We can and must do more 
to control its spread and work on new surveillance, control, 
and treatment efforts to mitigate future spread. I understand 
that you do have legislation that you mentioned that you have 
introduced several times, and I am happy to join as a cosponsor 
of that legislation.
    I know that we have all heard stories of young people and 
even adults who suffer from extreme fatigue and joint pain due 
to Lyme disease. While Lyme disease is rarely fatal, symptoms 
can at times be debilitating. And as I know we will hear from 
our witnesses today, I, like others, know people who have 
suffered from this disease. And one of the things that has been 
very troubling to people I know is that the disease was not 
diagnosed at first.
    And so I know CDC reports that there are a few cases in 
California. And I would actually question that and believe that 
it is probably underreported, especially in the Central Valley 
area of California. CDC just says there were 200 cases in 2010, 
and I would venture to say that I wonder if that is actually an 
undercount.
    In June 2012, there was an article in The New York Times 
that says that we are all still trying to understand the 
transmission of Lyme disease. I wanted to quote from that 
article:

        ``Deer ticks are aptly named, in a sense; a 
        northeastern deer can carry over 1,000 of these ticks 
        on its body. But as far as humans are concerned, the 
        ticks might be more relevantly called mouse ticks. That 
        is because white-footed mice and other small mammals, 
        not deer, are now known by scientists to be major 
        carriers of the disease.''

While long thought that deer contribute greatly to Lyme disease 
transmission, other animals are now suspected, including birds.
    I hope current research and data collection is leading to 
new possible solutions for areas in communities hardest hit but 
also on the front lines where we are seeing new cases. I would 
note that some studies suggest increasing temperatures and 
changes in precipitation patterns may be partially to blame for 
increased spread. If changes in weather patterns are to blame, 
I think we should take a look at the surge in cases in the U.S. 
and understand if there is a relationship. Surveillance and 
control is critically important in today's expanding field, 
where more and more States and counties are seeing new cases. I 
imagine some of the data that shows an increase in incidence is 
probably due to improved detection.
    I welcome witnesses' recommendations on what can be done 
policy-wise to address Lyme disease and other similar diseases. 
As we move to control this disease, CDC and others report that 
the best way to prevent infection in the first place is really 
around awareness. Local health departments and agencies appear 
to be increasing awareness, raising efforts as the Nation 
enters the spring and summer months.
    As we look at current and future funding, how can we 
effectively distribute limited resources to improve our 
Nation's response to this emerging disease?
    And I know your legislation essentially would call for 
that. The task force that would be looking at it would look at 
the resources and figure out the best way. I don't know if that 
is correct in my understanding in reading it.
    It is my hope that as the U.S. continues to lead on Lyme 
disease that we can also work with the World Health 
Organization to prioritize the disease's continued emergence in 
other regions, including in Asia.
    I thank you for today's hearing.
    Mr. Smith of New Jersey. Thank you, Ms. Bass.
    I would like to now recognize, without objection, two 
Members--they are not members of the subcommittee, but very, 
very welcomed today, beginning with Mr. Gibson, the gentleman 
from New York.
    Mr. Gibson. Well, thank you, Mr. Chairman and to the 
ranking member. I want to begin by just thanking you for your 
leadership on this critical issue and for the way that you work 
together, which I think is so vitally important.
    I want to also recognize Mr. Wolf. I know that all these 
Members here today have really been working this issue for Lyme 
awareness, diagnosis, treatment, and coverage from insurance 
companies very hard.
    And I wanted to be here because, from listening to you, Mr. 
Chairman, I think that we have ended up here for the same 
reason. This has been constituent-driven. This is a major 
public health issue in upstate New York. And, you know, shortly 
after retiring from the Army and returning home a couple years 
ago, it was clear to me that--a couple things. One, there are 
so many folks in upstate New York that are suffering from this 
affliction and are confused--confused because they look to the 
medical community to get well, and we find the medical 
community divided.
    We need to bring them together. And I think the task force 
is a great way to do it. We also appropriated last year in the 
Congress moneys for better research, awareness research toward 
diagnosis. But I also think it is vitally important that we 
follow up to make sure that those appropriations, those moneys, 
end up in the right place. Because I know that we have 
appropriated money in the past and ended up with the same 
results. So we have to make sure that we get the right folks 
that are doing the research on this.
    But I am optimistic. I am optimistic because, coming out of 
the constituent-driven symposium that we held in upstate New 
York, we were beginning, I think, to find some common ground. 
We actually had participation from some of those on both sides. 
Insurance companies were there, as well. And perhaps most 
encouraging is research which I think will be published, 
perhaps in the next year, about really how co-infections, I 
think, can go a long way to explain the chronic illness that 
the constituents are incurring attendant to a tick-borne bite.
    So, you know, toward that end, I will end where I began by 
thanking the chairman and the ranking member for holding this 
hearing. I look forward to hearing from the witnesses, and 
certainly want to stay engaged in moving us forward in a 
positive way.
    And I yield back. Thank you.
    Mr. Smith of New Jersey. Thank you very much, Mr. Gibson. 
Thank you for your leadership.
    I would like to yield to Chairman Frank Wolf.
    Mr. Wolf. Thank you, Mr. Chairman. I want to thank you and 
the ranking member for the hearing.
    This is a big issue in my congressional district, out in 
Loudoun Valley all the way out to the Shenandoah Valley, and we 
now see it spreading throughout the entire State of Virginia. 
For the longest period of time, you have long been a lone 
voice. And had it not been for you sort of crying in the 
wilderness, if you would, to force the different groups to come 
together--so I just want to second what was said and thank you 
for your leadership here.
    I look forward to something very good whereby we can come 
to the day that there is a consensus on how we can treat Lyme 
and how we can diagnosis it, how we can treat it, but also how 
we can prevent it.
    And, with that, I yield back.
    Mr. Smith of New Jersey. Thank you very much, Mr. Wolf.
    I would like to now introduce our very distinguished panel, 
beginning first with Dr. Stephen Barthold, who is a professor 
of medical pathology at the University of California, Davis and 
director of the U.C. Davis Center for Comparative Medicine. He 
served as a captain in the U.S. Army Veterinary Corps and at 
the U.S. Army Research Institute of Environmental Medicine and 
was a professor of comparative medicine at the Yale School of 
Medicine. Dr. Barthold was elected to the National Academies' 
Institute of Medicine in 2001 and is the recipient of several 
career awards. His research has been funded continuously by the 
NIH for 35 years, including a focus on Lyme for the past 25 
years.
    We will then hear from Dr. Raphael Stricker, who received 
his medical degree and training in internal medicine at 
Columbia University in New York and is currently medical 
director of a multispecialty practice in San Francisco. Dr. 
Stricker is past president and currently vice president of the 
International Lyme and Associated Diseases Society. He is also 
a member of the Federation of Clinical Immunology Societies and 
the American Federation for Medical Research. He is a recipient 
of the American Medical Association Award for Physician 
Excellence and an Outstanding Reviewer Award from the Annals of 
Internal Medicine. Areas of special interest include tick-borne 
diseases.
    We will then hear from Dr. Mark Eshoo, who earned his Ph.D. 
from the University of California, Davis and performed his 
postdoctoral studies at Stanford University. He has over 20 
years of research experience in the field of genomics and 
genetic analysis. Dr. Eshoo's research has resulted in the 
testing of many thousands of ticks collected from the U.S. and 
Europe for a wide range of tick-borne pathogens. He has led the 
development of sensitive procedures to detect tick-borne 
pathogens from a variety of clinical specimens, and is the 
director of new technology development at IBIS Biosciences.
    We will then hear from Pat Smith, who is in her 15th year 
as president of the national nonprofit Lyme Disease 
Association. She is a member of Columbia University's Lyme and 
Tick-Borne Diseases Research Advisory Committee, the Food and 
Drug Administration's PESP Partnership to promote avoidance of 
tick exposure, and an advisor to the Lyme Research Alliance. 
She is also former chair of the New Jersey Governor's Lyme 
Disease Advisory Council and was the FDA's 2011 Lyme prevention 
conference session co-chair with the CDC. She has spent 27 
years advocating for Lyme disease mitigation and combating this 
disease, raising money for both research and a children's fund.
    We will then hear from Evan White, who has utilized his 
experience in recovery from chronic Lyme disease to serve as an 
advocate for the treatment rights of Lyme disease patients for 
nearly 20 years. Evan has testified before a U.S. Senate 
subcommittee on behalf of himself and Lyme disease patients 
nationwide and has been a featured speaker at numerous Lyme 
disease functions. Evan's story as a patient and advocate has 
been covered by several major news media. Evan currently lives 
in New York City with his wife Michelle, where he is a labor 
and employment attorney and cofounder of the firm White Harris.
    Then we will hear--and this is by way of hookup with the 
UK--Ms. Stella Huyshe-Shires, who started her professional life 
as a plant pathologist before undertaking a research fellowship 
with IBM into the use of databases in plant research and moving 
into computing. She contracted Lyme disease in 1999 while 
working in her garden in Devon, United Kingdom, and was 
diagnosed 3 years later. She was retired from her IT job in the 
National Health Service on grounds of ill health. She joined 
Lyme Disease Action in 2007 and became its chairman in 2009. 
And we thank her for her willingness to join us at this hearing 
today from England.
    I would like to now ask Dr. Barthold if you could proceed 
with your testimony.

    STATEMENT OF STEPHEN W. BARTHOLD, PH.D., DISTINGUISHED 
     PROFESSOR, DEPARTMENT OF PATHOLOGY, MICROBIOLOGY AND 
     IMMUNOLOGY, CENTER OF COMPARATIVE MEDICINE, SCHOOL OF 
      VETERINARY MEDICINE, UNIVERSITY OF CALIFORNIA, DAVIS

    Dr. Barthold. Well, thank you for the opportunity to speak 
to this subcommittee. I appreciate the recognition of what we 
have been doing.
    As you pointed out, I have been working on Lyme disease for 
25 years in animal model systems. And one of the things that 
has intrigued me the most is the fact that Borrelia persists in 
its immunologically competent hosts as the rule, not the norm, 
and so persistence is part of its biological behavior. And this 
has been shown in 100 percent of mice, rats, hamsters, guinea 
pigs, gerbils, dogs, and nonhuman primates--two different 
species of nonhuman primates.
    And so, when you have an organism that is a professional at 
persisting and evading host immune clearance, you have a 
problem when you approach it with antibiotics. The antibiotics 
are likely to fail under some circumstances, if not many 
circumstances.
    And so, this has been challenged. I find myself in a rather 
contentious field, at this point, coming out of the mainstream 
of Lyme disease research into one in which I am somewhat of a 
pariah, in terms of the established medical opinion.
    In animal models, we know that early treatment during the 
pre-immune phase of the infection, we can cure the animals. But 
during persistent infection, 100 percent of the animals remain 
persistently infected after antibiotic treatment. And we are 
not alone. This has been described in a number of different 
laboratories: One in Finland, one in New York, one in 
Louisiana, one in Connecticut, and then in our own lab in 
California. It has been described in mice, in dogs, in nonhuman 
primates. It has been described with a number of different 
antibiotics, including ceftriaxone, doxycycline, tigecycline, 
amoxicillin, azithromycin.
    And all of these studies have pointed to some commonality, 
some rather convincing evidence of spirochetes which are 
unusual in that they can no longer be cultured. We put clonal 
populations into a mouse, but we get these nonculturable forms 
out. And our naysayers have said this is residual DNA debris. 
But that ``DNA debris'' is transcribing RNA, which means it is 
a metabolically viable organism. We can acquire the infection 
feeding ticks upon the treated the animals, so-called 
xenodiagnosis. And we can look in the ticks and we see 
morphologically intact spirochetes that are viable. We can also 
look in the tissues of the animals that have been treated with 
antibiotics and we see morphologically intact spirochetal 
forms.
    Ticks can acquire the infection. They can transmit the 
infection back into naive hosts. We can transplant the 
infectious material with tissues containing organisms from the 
treated mice to naive animals.
    And in my written testimony, I have included some 
unpublished data, which we hopefully will get published in the 
next year or so, that shows after 12 months after treatment of 
mice we see resurgence of spirochetes in very large numbers, 
equivalent to numbers of wild-type infection in which the 
animals have not been treated with antibiotics.
    So the significance of this remains to be determined. Are 
these pathogenic organisms? Everyone in this room is infected 
subclinically with a virus, bacteria, fungus, or all of the 
above, and under some circumstances those organisms can cause 
disease. And it varies from individual to individual.
    So it remains to be determined, the significance of these 
persisting organisms, and they by no means indicate chronic 
Lyme disease or an example of post-Lyme disease syndrome. But, 
certainly, something unique is going on with Borrelia 
burgdorferi, and it needs further study.
    And that is pretty much my testimony.
    Mr. Smith of New Jersey. Thank you very much, Doctor.
    [The prepared statement of Dr. Barthold follows:]
    
    
    
                              ----------                              

    Mr. Smith of New Jersey. Without objection, all of your 
full and very extensive testimonies will be made a part of the 
record.
    Dr. Stricker?

     STATEMENT OF RAPHAEL STRICKER, M.D., VICE PRESIDENT, 
       INTERNATIONAL LYME AND ASSOCIATED DISEASES SOCIETY

    Dr. Stricker. Thank you, Mr. Chairman, members of the 
committee, honored guests.
    First, let me take this opportunity to thank the committee 
for inviting me to speak about the growing international health 
threat of Lyme disease.
    I am a practicing physician in San Francisco with a 
specialty in internal medicine. I am also vice president of the 
International Lyme and Associated Diseases Society, or ILADS, 
an international organization of medical providers with 
expertise in treating patients with Lyme disease and associated 
tick-borne illnesses. I currently have over 2,000 Lyme disease 
patients in my practice, and I have watched the number of 
patients with this disease grow exponentially over the past 15 
years.
    Patients come to me from all over the United States and 
around the world: From Connecticut to California, from Canada 
to Costa Rica, from Great Britain to Brunei, and from Germany 
to Japan, and, yes, even from New Jersey. Many of these 
patients have been ill for years, and, sadly, they have been 
unable to find a medical provider who can diagnose and treat 
them for Lyme disease.
    My practice reflects the increasing rate of Lyme disease in 
the United States and around the world. This increase should 
not be a surprise to anyone; after all, Lyme disease is the 
most common tick-borne disease in the world today. It is caused 
by a spiral-shaped bacteria that is transmitted by the bite of 
a tick, as you have heard. Patients with Lyme disease develop a 
combination of muscle and joint symptoms, neurologic problems, 
and heart abnormalities that may be severe and debilitating.
    Yet, in spite of the fact that the disease is so common, 
medical providers are often ignorant about how to diagnose and 
treat Lyme disease. There are a number of reasons for this 
ignorance. First, the telltale bullseye rash that is a classic 
sign of Lyme disease may be absent in more than half of Lyme 
disease patients. Absence of the classic Lyme rash makes the 
diagnosis of the disease much more difficult. Second, patients 
are often unaware of a tick bite. In many parts of the world, 
the black-legged tick that transmits Lyme disease may be no 
larger than a poppy seed and easily missed.
    Third, Lyme disease may have a wide range of symptoms, and 
physicians are often unaware of the highly variable 
manifestations of the disease. Fourth, testing for Lyme disease 
remains problematic. For historical reasons, most laboratories 
around the world use tests that are unstandardized and 
insensitive, and these tests give negative results in about 
half the cases of Lyme disease. Fifth, treatment of Lyme 
disease has evolved in a haphazard fashion. The ``standard of 
care'' for treating Lyme disease put forth by specialty medical 
organizations, such as the Infectious Diseases Society of 
America, or IDSA, only addresses acute infection immediately 
following a tick bite. The IDSA standard ignores the more 
common and severe chronic form of Lyme disease that many of my 
patients suffer from.
    For all of these reasons, Lyme disease has become an 
international medical disaster. We have seen thousands of 
patients around the world who have suffered the dire 
consequences of undiagnosed and untreated Lyme disease. Their 
stories fill up pages and pixels in medical journals, newspaper 
articles, documentary films, YouTube videos, and online 
magazines. Yet our specialty medical organizations, such as 
IDSA, sit by and do nothing.
    In California, we are grateful to the State legislature and 
the Department of Health Services for establishing the Lyme 
Disease Advisory Committee with the goal of educating medical 
providers and the public about Lyme disease. We have 
established mandatory laboratory reporting of positive Lyme 
disease tests directly to the Department of Health Services, 
just like the system for reporting syphilis, tuberculosis, HIV 
disease, and other public health threats. We also have a 
physician protection law that allows healthcare providers to 
care for Lyme disease patients in the most medically 
appropriate manner.
    These essential steps should serve as a model for a 
national tick-borne disease program with a national Lyme 
disease advisory committee representing all stakeholders, a 
national and even international reporting system for positive 
tick-borne disease testing, and national legislation to protect 
healthcare providers who treat patients with the chronic form 
of Lyme disease.
    Beyond these short-term goals, we need the Centers for 
Disease Control and Prevention, the CDC, and the National 
Institutes of Health, the NIH, to abandon their failed Lyme 
disease programs. We need the CDC and the NIH to promote 
targeted research to develop better diagnostic tests for tick-
borne diseases, just as they did for AIDS. We need the CDC and 
the NIH to develop more effective treatments for patients who 
suffer from the chronic form of Lyme disease.
    We cannot do this if specialty medical societies continue 
to turn their backs on these patients because those societies 
ignore the evidence that chronic Lyme disease exists. We need 
to get these organizations to look at the evidence, to discard 
dogmatic opinions that are out of date, and to start helping 
sick patients instead of contributing to the pain and suffering 
of those patients.
    Above all, we need to listen to the voices of patients with 
Lyme disease. You will hear some of those voices today. The 
voices come from people in every walk of life, in every corner 
of our society, and in every corner of the world. Those voices 
need to be heard.
    Almost 2 decades ago, a courageous physician named Joseph 
Burrascano testified at a Health Committee hearing of the 
United States Senate. The committee had just been reassured by 
prominent members of the medical establishment that Lyme 
disease was a trivial illness that was ``hard to catch and easy 
to cure.'' Dr. Burrascano spoke these words:

        ``The very existence of hundreds of Lyme support groups 
        in the country and the tens of thousands of 
        dissatisfied, mistreated, and ill patients whom these 
        groups represent underscores the many problems that 
        exist in the real world of Lyme disease.''

Almost 2 decades later, those problems still exist in the real 
world of Lyme disease. We can and we must address those 
problems for the benefit of everyone in our international 
community.
    Thank you very much for your attention.
    Mr. Smith of New Jersey. Thank you so very much, Dr. 
Stricker.
    [The prepared statement of Dr. Stricker follows:]
    
    
    
                              ----------                              

    Mr. Smith of New Jersey. Dr. Eshoo?

   STATEMENT OF MARK ESHOO, PH.D., DIRECTOR, NEW TECHNOLOGY 
                      DEVELOPMENT, ABBOTT

    Mr. Eshoo. Hello. Thank you for the invitation to address 
the committee. I represent IBIS Biosciences; we are a part of 
Abbott. And, obviously, our interest has been in developing 
better diagnostics for Lyme disease.
    You know, as we heard earlier, Lyme disease is caused by a 
bacteria called Borrelia burgdorferi and is the most commonly 
reported vector-borne infectious disease in North America and 
is also found around Europe and Asia. The number of cases has 
been steadily increasing, and it is estimated that this disease 
is severely underreported.
    Other tick-borne diseases are also very important, such as 
the protozoan parasite Babesia, which is found worldwide. And 
in many parts of the world, such as Africa, Babesiosis, the 
disease caused by Babesia, is frequently mistaken for malaria. 
In regions with Lyme disease, there are also a large number of 
other tick-borne pathogens that are typically present, leading 
to a high risk of co-infection with Lyme disease.
    Now, in nature, Lyme disease is spread by ticks to mice, 
which act as the reservoir of the disease. The infected mice 
then infect more ticks, and then the ticks then infect more 
mice. Though these mice are infected, they don't die but, 
rather, become chronically or long-term infected. This is 
because if the mouse dies, so will the bacteria that cause Lyme 
disease.
    To survive in the mice, these bacteria have evolved several 
clever tricks to evade the mouse's immune system. One of the 
ways they do this is by infecting the parts of the mouse's body 
where it is hard for the immune system to attack the 
infection--the skin, the joints, the nervous system. Now, when 
people become infected by a tick bite, the Lyme bacteria do the 
same things as they do in the mouse. The infections can be 
long-lasting or chronic. They can spread through the skin, 
which we see as a bullseye rash. They can invade the nervous 
system and cause neurological Lyme disease or infect the 
joints, causing Lyme arthritis.
    The best time to treat Lyme disease is at the first sign of 
symptoms. The challenge is that the symptoms of early Lyme 
disease are varied and frequently mistaken for other illnesses. 
The most typical symptom of early Lyme disease includes the 
bullseye rash; however, this bullseye rash is present in a 
little over half of Lyme infections. The other symptoms of 
early Lyme disease are typically flu-like--fatigue, fever, and 
headache. Thus, early Lyme disease can be very difficult to 
clinically diagnosis by physicians who are not Lyme disease 
specialists.
    The current diagnostic for Lyme disease is called the two-
tiered test, and it does not directly detect Lyme bacteria but, 
rather, looks to see if the patient's immune system has 
developed antibodies against the bacteria.
    There are three main problems with the current two-tiered 
test. The first is that it can take a Lyme patient 3 weeks or 
more after its infection with Lyme disease bacteria for the 
immune system to develop enough to test positive. Thus, 
treatment could be delayed during the critical early period of 
the infection.
    The interpretation of the two-tiered test results can be 
subjective, with essentially the same test from the same 
patient being performed by two separate labs reporting opposite 
results.
    Thirdly, once a person has had Lyme disease, they will 
continue to test positive even after treatment due to the fact 
that the immune system remains active against the Lyme 
bacteria. Because of this fact, there is controversy over how 
much treatment is needed to cure Lyme disease, with some 
physicians recommending antibiotic treatment for a couple of 
weeks, with other physicians recommending treatment with 
antibiotics for months to years.
    At Abbott Labs' IBIS division, we have applied our 
technology to detect a wide range of tick-borne pathogens based 
upon the detection of the pathogen's DNA, or directly looking 
for the pathogen's DNA. The challenge of Lyme disease tests is 
that there is very little Borrelia bacteria and its DNA 
circulating in the bloodstream of patients with early Lyme 
disease, making a sensitive direct assay very difficult.
    To address this challenge, we have worked to improve the 
sensitivity of our Lyme assay by several means. First, we 
employ an assay that consists of eight independent tests for 
the Lyme disease-causing bacteria. This way, we have eight 
chances of finding the bacteria's DNA in the blood. Secondly, 
we use a very large volume of blood in the test, thereby 
increasing the chances of finding the bacteria in a given 
specimen.
    And, thirdly, we employ a technique to increase the 
bacteria's DNA in the specimen. Initial results of this 
approach have been very, very encouraging. In a recent study of 
21 patients with confirmed early Lyme disease, we detected Lyme 
disease in 62 percent of those patients' blood specimens at 
their first doctor's visit. We believe this work demonstrates 
it is possible to develop sensitive and direct tests for Lyme 
disease. However, there is a great deal of work needed to make 
this test suitable for use in clinical diagnostics.
    Another area of interest for us and research has been 
looking at variations in the bacteria. Many pathogenic bacteria 
come in various strains, and these strains may determine the 
type and severity of disease that they cause. For example, E. 
coli comes in many strains, many of which are harmless but 
others that can cause serious illness. Worldwide, we have 
identified over 100 different strains of Lyme disease-causing 
bacteria in ticks. Knowing the roles of these strain 
differences may be important to knowing the potential types of 
Lyme disease to look for and how best to treat the infections.
    There are three areas that we think are needed to fill the 
gaps. We believe we need more government research and funding 
in three key areas.
    First, we believe that we need research and development to 
make a sensitive test that can directly detect the Lyme 
disease-causing bacteria. Such a test would enable detection of 
Lyme disease earlier in the infection before the bacteria are 
able to spread throughout the body. Such a test would then also 
enable the physician to monitor the responses to treatment.
    We also need a better understanding of the roles and causes 
of post-treatment Lyme disease. Why don't the symptoms resolve 
following treatment for a large and significant number of Lyme 
disease patients? And, again, we believe a sensitive direct 
diagnostic may be instrumental into understanding the causes of 
these symptoms.
    Lastly, many pathogenic bacteria come in these various 
strains and types, and we need increased research into the 
roles of the Borrelia strain differences in Lyme disease in 
humans.
    Mr. Smith of New Jersey. Thank you so very much, Dr. Eshoo.
    [The prepared statement of Mr. Eshoo follows:]
    
    
    
                              ----------                              

    Mr. Smith of New Jersey. Pat Smith, if you would proceed 
now.

   STATEMENT OF MS. PATRICIA SMITH, PRESIDENT, LYME DISEASE 
                          ASSOCIATION

    Ms. Smith. Thank you for the opportunity to testify on a 
problem I have seen blossom from a regional into an 
international issue.
    Twenty-seven years ago, I saw the devastation in my school 
district caused by an unknown disease affecting staff and 
students. To educate myself and my fellow school board members, 
I had to contact a nearby naval base, although many of my 
inquiries were answered with, ``That's classified.''
    The past 20 years, I have traveled the country, 15 as 
president of the all-volunteer national nonprofit Lyme Disease 
Association, listening to patients, scientists, doctors, and 
government officials. Through the perspective of Lyme, I have 
found that some individuals charged with public welfare have 
lost their focus. Instead of solving the problems of humanity, 
some have abrogated their responsibilities, affecting people 
worldwide.
    Over time, I have heard Lyme called a housewives disease; a 
yuppie disease; hard to catch, easy to cure; heard patients 
referred to as hysterical, faking, crazy, paranoid, even 
antibiotic-seeking; and heard Lyme advocates portrayed as 
crazed know-nothings responsible for mass hysteria over Lyme. 
Many U.S. organizations and others in the world have been 
victimized in peer-reviewed literature by noted researchers who 
don't agree that Lyme doctors should be permitted to use 
clinical judgment in treating Lyme, attacking those who are 
working tirelessly to raise research and education funds for 
Lyme disease--that is, the advocates and the patients. Many 
patients confide to me they would rather have cancer.
    CDC and NIH have awarded grants to many of the same people, 
some for studies that rely on the strict CDC surveillance 
criteria for inclusion, including the use of the faulty 
nonsensitive tests. Thousands of patients have questioned this 
practice, and they ask for studies which can provide solutions 
to their dilemmas as chronic Lyme patients: ``My doctor won't 
treat me when I am sick''; ``No one believes my children and I 
are sick.'' A common refrain is, ``Why isn't the government 
doing anything about Lyme?''
    NIH funded several treatment studies, and the broad-brushed 
conclusions put a nail in the coffin of Lyme patients. One 
could possibly conclude from the studies that the specific 
treatments used by the study participants over the length of 
the study were not effective for the restrictive populations 
chosen for research purposes. However, instead, the conclusions 
became: No long-term treatment is effective for anyone with 
Lyme. Many doctors in mainstream medicine who had treated Lyme 
to date now turned a blind eye and a deaf ear to patients with 
Lyme.
    The CDC Lyme surveillance system is in shambles. CDC 
criteria have become stricter, reducing the patient pool for 
reported cases. Lyme surveillance is very labor-intensive, 
including calling doctors to verify case reports. And human 
resources have been cut, forcing States to institute cost-
savings measures involving changing case reporting methods, 
affecting national and regional numbers.
    Officials continue to declare there is no Lyme in the South 
or the Midwest. And reasons given for that stance range from: 
``There are no deer ticks in the South; if there are deer ticks 
there, they are not infected with Lyme because there are no 
reservoir hosts in the South,'' and those are small mammals 
that carry Lyme bacteria and transmit it to the ticks who 
infect people. ``Deer ticks in the South feed on lizards, which 
do not transmit Lyme bacteria to ticks.'' ``Deer ticks in the 
South behave differently.'' And, really, my favorite, ``And 
deer ticks in the South do not bite people.''
    Scientific studies do not support those conclusions, yet 
many physicians still refuse to diagnose and treat Lyme in the 
South, forcing those patients to seek medical treatment in 
endemic areas of the country, adding to the already-
overburdened medical practices there.
    Compounding the problem, the very strict Lyme definitions, 
meant for surveillance only, are abused by mainstream medicine, 
insurance companies, pharmacists who won't even fill 
prescriptions for Lyme patients, and even public officials who 
are charging moms with Munchausen's-by-proxy. And believe it or 
not, in this day and age, they are taking away their children. 
And what is their crime? Having a licensed doctor prescribe an 
antibiotic for their children's Lyme.
    On its Web site, CDC disclaims any responsibility, stating 
its criteria are for surveillance only. But its actions belie 
that position. CDC openly endorses IDSA guidelines, which are 
featured on its Web site--guidelines written by researchers, 
not clinicians who care about patient outcomes. For example, 
the IDSA guidelines recommend against any long-term treatment 
with antibiotics, they recommend against any alternative 
treatments, and they recommend against any supplements for Lyme 
patients. And patients have no treatment options open to them 
under these guidelines, even if they can find a doctor who is 
willing to treat under the threat of license removal for 
exercising clinical judgment in treating Lyme.
    The CDC criteria form the basis of the IDSA guidelines. 
Intertwined, inseparable, like strands of a rope, they form a 
noose around the neck of Lyme patients, sometimes leaving them 
to die a very slow, painful death without medical treatment.
    Even in death there is no rest for the Lyme victims and 
their families. A published study examined 114 death 
certificates listing Lyme as a cause, and the researchers 
concluded--and I have to quote this--``Most terminal events 
listed on death certificates for which Lyme was the underlying 
cause of death were inconsistent with the well-characterized 
complications of Lyme disease,'' leaving only one death record 
standing as Lyme disease--a conclusion, by the way, they 
reached without even conducting medical chart reviews.
    Researchers have concluded Lyme causes more pain and 
suffering than osteoarthritis, myocardial infarction, and Type 
2 diabetes. But they still have not let patients have any 
recourse, denying any clinical judgments in patients who 
otherwise have no treatment options.
    Since Lyme often affects more than one family member and 
those at the highest risk are our children ages 5 to 9, mothers 
often have to forgo their own treatment to save their children. 
And these same moms are then accused of Munchausen's-by-proxy, 
a controversial diagnosis which blames parents for making their 
own children sick. I have advocated for patients and children 
whose schools accuse them of faking illness, despite reputable 
research showing a drop in IQ of 22 points in children with 
Lyme rectified by antibiotic treatment. I have mourned with 
those families whose children committed suicide after leaving 
notes which said no one believed them to be sick and they could 
not bear the pain of the disease and the rejection.
    And in conclusion, I want to say that this hearing has 
provided a public forum for Lyme issues to be discussed before 
an impartial audience with the ability to initiate and 
implement changes. Whatever our differing viewpoints today, we 
all came to testify to be part of that solution. I came today 
as a grandmother of four, trying to protect my granddaughters 
and others against the agonies of Lyme experienced by two of my 
very own daughters.
    Yet, as I look around the room, I notice the absence of the 
key players in Lyme--CDC, NIH, IDSA--who were invited to be 
part of the solution. Instead, they chose consciously to remain 
part of the problem--at the least, abrogating their 
responsibilities; at the worst, violating a basic tenet of 
medicine: First, do no harm. They need to be brought to this 
table with patients, advocates, and treating physicians, who 
have before this time been locked out of the process, so that 
patients who suffer from Lyme can find treatment and the 
millions of potential victims worldwide can be spared the 
medical and political debacle we call Lyme disease.
    Thank you.
    Mr. Smith of New Jersey. Ms. Smith, thank you so very much 
for your advocacy as well as your testimony here today.
    [The prepared statement of Ms. Smith follows:]
    
    
    
                              ----------                              

    Mr. Smith of New Jersey. I would like to now invite Evan 
White to testify from New York City. His wife just gave birth 
last week, so we congratulate him on a blessed event. So, Mr. 
White, if you could begin now by way of Skype.

       STATEMENT OF MR. EVAN WHITE, LYME DISEASE PATIENT

    [The following testimony was delivered via Skype.]
    Mr. White. Thanks again for having me by video. It is 
appreciated. I have been an advocate for Lyme disease for over 
the course of 20 years, and my advocacy for Lyme disease is 
really borne out of a very tragic and unfortunate case of 
chronic Lyme disease that I was subjected to because of a 
doctor's insistence on providing me with limited antibiotic 
treatment. At the other end of the spectrum, I am well, and I 
am able to be here with you today because of conscientious 
doctors that have provided me with careful, long-term 
treatment.
    Today I am a father, husband, practicing attorney, business 
owner, employer, and advocate for the rights of Lyme disease 
patients. Now, I mention that to illustrate a point, not to be 
boastful. My point is that were it not for this long-term 
treatment by a careful and conscientious Lyme physician, none 
of this would be possible. And I raise that to illustrate the 
fact that so many of our Lyme constituents do not have the 
benefits that I had. Certainly by comparison, if they did, my 
belief is that they, too, would be able to live fulfilling, 
recovered lives and be contributing members of society.
    So my story has a happy ending. That being said, I am here 
to fight for the same for all of my fellow Lyme constituents. 
Obviously the nature of roadblocks and obstacles in achieving 
that for everyone are these outdated and unduly limited 
treatment guidelines that, you know, turn a blind eye to what 
we as patients and people in the Lyme community know as 
effective treatment.
    My personal story is really a real-life case study to 
illustrate these points, that short-term antibiotic treatment 
can be absolutely devastating, and then long-term treatment, 
conversely, can reverse these effects sometimes. In fact, that 
is what we are fighting for.
    Now, my story begins over 21 years ago in the fall of 1991 
as an 11-year-old going on 12, going into middle school, when I 
began to all of a sudden miss several days of school due to 
flulike symptoms. Unlike with the other Lyme patients, my 
physician was able to diagnose me properly with Lyme disease. 
Unfortunately, we--like so many physicians today, that was met 
with the improper and catastrophic response of insufficient 
treatment and approximately a week, 2 weeks of antibiotic 
treatment.
    Now, the response to my not recovering after 2 weeks was 
one that is very common and unfortunate in the Lyme community, 
and that was to recommend a treatment of physical therapy and 
psychological therapy. As I was taken off medication and 
persisted with that course of treatment, I noticed daily that 
my condition was deteriorating. I had placed my faith in these 
physicians and, as a 12-year-old, knew nothing else other than 
to trust my doctor.
    Lo and behold, after 6 months the deterioration was so 
severe that I was really having great difficulty performing any 
activities. I certainly hadn't been to school; I hadn't even 
had any home schooling. Even simple tasks like getting out of 
bed became virtually impossible.
    When we turned back to the blood tests, my doctors were 
surprised Lyme disease was still very present along with other 
co-infections in my blood. What we had learned there is an 
example of the devastating impact of untreated Lyme disease, 
and one that is met with what represents the current suggested 
treatment.
    This 6-month layoff from Lyme treatment sent me in 
tailspin. It was a virtual nightmare for myself and my family 
as my condition vastly deteriorated, and I was really 
transformed over the course of the year from an active, 
healthy, athletic child to one that essentially couldn't even 
care for myself. I was about 60 pounds. This treatment had 
caused me to experience great muscle atrophy, as well as 
neurological defects, so just a drastic, striking contrast in 
my life that was absolutely devastating. For lack of a better 
term, by the time I was age 13, I was essentially a vegetable.
    Doctors were really baffled and confused by my condition, 
by the severity of it. Their only solution at that time was to 
place me full time in children's rehabilitational care. What 
had ensued, fortunately, for me afterward was the type of brain 
scan that revealed that this unfortunate medical treatment had 
caused Lyme disease to penetrate the blood brain barrier, 
causing hypoperfusion within my brain, and this offered some 
explanation, some insight into why I was unable to essentially 
take care of myself, essentially perform even the most basic 
functions like reading, talking, communicating, things like 
that. That being said, I was still surrounded by doctors who 
were totally confused and confounded and had absolutely no idea 
what condition I was suffering from or why.
    Shortly, after spending about 2 years bouncing from 
hospital to hospital, 6 months in a children's institution, I 
was sent home to receive outpatient treatment. And right around 
that time my parents, who were incredibly dedicated to 
assisting me and helping me recover, were able to arrange for 
an appointment with a very prominent Lyme disease physician. 
This person essentially got it. When I met with him, I finally 
felt understood. I mean, this person had their own personal 
experience with the disease to bring to the table, not to 
mention a day-in, day-out practice and a repetition and seeing 
and treating patients with the disease.
    Now, I had a long road ahead of me to recovery, but what 
had transpired there was really a turning point for me and for 
my life entirely. This physician was able to treat me, put me 
on a long-term treatment program, long-term antibiotics, 
coupled with therapy and other essential supplements that he 
recognized as necessary. And it was a 2-year crawl, but if it 
even were a 10-year crawl to get me out of that unfortunate 
place that I was in, that would be just fine with me.
    Through hard work and attentive treatment from this doctor, 
I was able to stop using a wheelchair, get out of bed, be able 
to function, take care of myself. My neurological symptoms 
began to dissipate. I began to be able to read, and communicate 
and converse. This was a very slow and long process, but 
ultimately, due to this physician's belief in me and treatment, 
he set me out on a trajectory that has allowed me to become the 
person that I am today.
    And I am happy to be fully recovered from Lyme disease, and 
certainly hoping through this testimony that patients that are 
afflicted by Lyme disease are not deprived of what I had the 
opportunity to do, and that is certainly my mission as someone 
who has recovered from symptoms of chronic Lyme disease.
    And in closing, what I am hoping that this subcommittee 
throws out there or people take away from my testimony is that 
my belief that the net effect of the current guidelines that 
are out there restricting treatment of Lyme disease patients 
ultimately deprived so many, if not all of them, who suffer as 
I have from the opportunity to have the healthcare option to 
seek long-term treatment that is effective, that is proven, and 
that has worked in allowing me and others who were fortunate 
enough to achieve normal, fulfilling, pain-free lives.
    Thank you.
    Mr. Smith of New Jersey. Mr. White, thank you so very much 
for your eloquent statement and for showing a way, I think, for 
many other Lyme patients that there is hope if the right 
treatments are procured. So thank you so much.
    [The prepared statement of Mr. White follows:]
    
    
    
                              ----------                              

    Mr. Smith of New Jersey. I would like to now welcome Stella 
Huyshe-Shires, who is the chair of the Lyme Disease Action for 
the United Kingdom.

  STATEMENT OF MS. STELLA HUYSHE-SHIRES, CHAIR, LYME DISEASE 
                             ACTION

    [The following testimony was delivered via telephone.]
    Ms. Huyshe-Shires. Lyme Disease Action is a nonprofit 
organization striving to improve the understanding of Lyme 
disease in the UK on behalf of doctors, patients, careers, 
employers and healthcare providers.
    In particular we have to improve the position of the 
doctors. If doctors are able to recognize, diagnose and treat 
Lyme disease, and have the means to do this, all other 
stakeholders will benefit.
    The whole of Europe is affected by the polarization of 
views concerning Lyme disease that has arisen from the IDSA/
ILADS controversy and it became apparent to Lyme Disease Action 
that UK doctors would not take us seriously without some 
official accreditation. We are therefore now accredited to our 
Department of Health Information Standard. This means that our 
information management processes have been verified to make 
correct, unbiased use of sources of evidence. There is 
disagreement on the incidence of European Lyme disease and the 
possible scale of the problem.
    Papers and Web sites written by health professionals 
normally say that Lyme is overdiagnosed, but those written by 
members of the public say that Lyme disease is underdiagnosed. 
What is the evidence?
    In the UK we don't know the incidence, as only positive 
blood tests are recorded; however, an audit at a highly aware 
GP practice has found an incidence 20 times that of the 
surrounding region. Extrapolating from this, it seems perfectly 
possible that the recorded figure for the UK of a mere 1,300 
cases may actually be 26,000.
    Is there evidence that Lyme disease is overdiagnosed? Well, 
a recent paper analyzed notes of all patients referred to a 
major infectious diseases clinic with possible Lyme disease. It 
reports that only 23 percent of the patients were diagnosed by 
the clinic as actually having Lyme disease, and 33 percent were 
diagnosed with chronic fatigue syndrome instead. The authors 
state these figures mirror similar studies in North America and 
voice their concerns that CFS patients are susceptible to 
misdiagnosis and inappropriate treatment.
    So yes, Lyme disease may be misdiagnosed in some cases, but 
the number of patients in the whole 5-year period was 42. Say 
12 similar clinics across the UK, this might mean about 100 
people a year in the UK being misdiagnosed with Lyme disease. 
Contrast that with the possible 20,000 real Lyme disease cases 
misdiagnosed with something else.
    Lyme disease isn't alone. A similar survey of patients 
referred to a specialist chronic fatigue syndrome clinic found 
that 40 percent of those patients have been misdiagnosed with 
chronic fatigue syndrome. The challenge there is for everyone 
to stop beating their own particular drum and ask why Lyme 
disease is difficult to diagnose and what can be done about it.
    Diseases that are rare and difficult take doctors' time and 
effort. They need unequivocal tests and clear guidelines. 
Unfortunately, neither of those exist in the UK for Lyme 
disease. In this small country with a relatively low incidence, 
most doctors haven't seen enough cases to gain experience, so 
there is a heavy reliance on tests, and doctors are likely to 
telephone the laboratory for clinical advice.
    The former head of the Health Protection Agency laboratory 
served as consultant to the IDSA panel in the development of 
2006 guidelines, so it is understandable that the views of IDSA 
have prevailed in the UK.
    The Health Protection Agency has also told doctors that 
Internet sources of information are unreliable, that the 
dangers to patients from misdiagnosis are considerable, and 
that tests from some laboratories are unreliable. All of this 
has an element of truth, but drawing attention to only this 
side of the coin is a misrepresentation of the state of 
affairs.
    A small number of UK microbiologists have drawn up, under 
the British Infection Association, a position paper on Lyme 
disease. Despite its biased view of the literature, it is used 
by professionals to support the view that Lyme disease can be 
definitively diagnosed by serology and does not persist after 
recommended treatment. Unfortunately, European research shows 
otherwise, but doctors don't have time for critical reading, 
and understandably they trust that their peers would have done 
a good job of drawing up guidance.
    Europe faces the challenge of more than one species of 
Borrelia burgdorferi, that has already been said, and this adds 
a complexity to serology tests. In Scotland the Lyme reference 
laboratory uses its own in-house Western blot, recording far 
more bands than are used in commercial test kits. No laboratory 
undertakes extra work like this without good reason.
    When it comes to treatment, the UK follows IDSA despite 
European guidelines which point out that there have been no 
good-quality European trials on agent, dose or treatment 
length, but most treatment recommendations are, in fact, based 
on opinion, not evidence. It does seem to us that there are 
uncertainties, but we need to get other skeptical stakeholders 
to examine this possibility, very difficult in the current 
climate of suspicion and disbelief in patient views.
    We have now started a process mediated by the James Lind 
Alliance which involves documenting doctors' and patients' 
uncertainties. To engage doctors in this has been taxing and 
only achievable because the British Infection Association, 
following our criticism of their paper, realized that that 
input was important. The collective uncertainties are now being 
examined against the published literature and systematic 
reviews, and this will result in a list of true uncertainties.
    The biggest challenge we face globally is the recognition 
and agreement on the uncertainties. There are other positive 
signs over here. The Health Protection Agency, following the 
reorganization and move of the Lyme reference laboratory, has 
now also engaged with us. However, across Europe lies this 
polarization of opinions along the ILADS/IDSA fault line, as 
recently illustrated by several journal articles.
    It can be hard not to see the collective publications that 
deny patient rationality as an orchestrated attempt to 
discredit an alternative view. It may, however, simply be a 
reluctance to climb out of an entrenched position.
    Earlier this year we attended the European Congress of 
Clinical Microbiology and Infectious Diseases in London. 
Discussions with a lot of international delegates were 
revealing. Northern European doctors face similar problems to 
the UK, with doctors relying heavily on test results. In 
Central Europe, where incidence of Lyme disease is far higher, 
doctors have more experience, and they were telling us Lyme is 
a big problem, we don't have good enough tests, and we don't 
know how to treat.
    To us here there seem to be two principle aspects to the 
Lyme disease problem: Politics and the uncertainties of the 
science. The politics drives patients to seek care away from 
the UK National Health Service, which is failing them. And it 
is politics which is preventing recognition of the 
uncertainties. Politics, prestige, and defense of positions 
should not obstruct patient care nor hamper the search for 
understanding.
    Thank you for inviting Lyme Disease Action to testify.
    Mr. Smith of New Jersey. Ms. Huyshe-Shires, thank you very 
much for your testimony.
    [The prepared statement of Ms. Huyshe-Shires follows:]
    
    
    
                              ----------                              

    Mr. Smith of New Jersey. And I thought I would start with 
you, if I could, on some questions and ask, perhaps, others to 
jump in.
    Mr. White in his testimony talked about the short-term 
antibiotic treatment being devastating to him. And in a London 
Telegraph article on May 16, 2011, in which you spoke to the 
reporter about how you waited 3 years for confirmation that you 
had Lyme disease, and then you got a low-dose antibiotic for 2 
weeks, standard treatment for Lyme, and it made absolutely no 
difference; then you went in the hospital for 2 weeks of 
intravenous antibiotics, you thought you would get better, but 
you got worse. If you just could speak to, you know, just what 
that was like to have the prescribed remedy seemingly 
inefficient and unavailing in your case.
    You also point out that doctors in Britain follow the 
advice of the Health Protection Agency, which adheres to the 
guidelines set by the Infectious Diseases Society of America, 
and, of course, those guidelines say that patients should not 
take antibiotics for longer than 28 days. But you then made the 
comment that scientists have found that Lyme can survive a 
short course of antibiotics, something that has been debated in 
this subcommittee by our other witnesses, citing a recent paper 
from the London School of Hygiene and Tropical Medicine.
    You might speak to that paper and some other data that you 
have come across. It would seem that the information being 
conveyed to at least the UK and perhaps the rest of the world 
by the Infectious Diseases Society of America is not just now 
affecting Americans, but people in other lands as well.
    Ms. Huyshe-Shires. Yes. As a patient who believes in the 
health service, to have a treatment that doesn't work is 
devastating. The worst thing is probably when people do not 
believe you; when patients with subjective symptoms are told, 
it is in your head, and it can be very hard. The IDSA 
recognizes that if you still have visible arthritis, then you 
may get some more treatment, but if you have invisible pain, 
then you cannot have further treatment.
    The Health Protection Agency does follow IDSA guidelines. 
Individual doctors often, or do sometimes, take an individual 
clinical decision. The paper that you mentioned looking at case 
studies for the London School of Hygiene and Tropical Medicine 
followed--looked at the case studies of patients, I think, over 
a 4- or 5-year period, and they documented the fact that there 
were some patients who did not recover after their initial 
course of antibiotics, so they were given a second course of 
antibiotics, and, when that didn't work, they were given a 
third course of antibiotics. And between each course the 
patients were believed, but they also checked on the serology 
and found a rising antibody titer in the blood test.
    Now, quite often people--doctors will not check the 
antibody level, will not check anything, and will just say, you 
have had adequate treatment, where ``adequate'' means conforms 
to some guidelines; ``adequate'' does not mean adequate to 
treat the disease.
    Mr. Smith of New Jersey. Thank you.
    Doctor Barthold, if I could ask you, in your testimony you 
ask, ``Does it survive following treatment, and if so, do 
surviving spirochetes cause chronic Lyme disease or post-Lyme 
disease syndrome?'' You have also testified that ``Research 
proposals submitted to NIH that feature persistence following 
treatment are likely to receive prejudicial peer reviews in the 
contentious environment of Lyme disease.''
    Could you elaborate on that? Are good, laudable proposals 
being rejected simply because they don't comport with, you 
know, an entrenched belief at the NIH?
    Dr. Barthold. Well, it is certainly not NIH that is at 
fault, it is peer review, and when peers are divided as 
everybody else in the Lyme community, then there is bound to be 
prejudice percolating into the review.
    I have direct experience with such prejudicial statements 
in grant applications that I have submitted. There may be fault 
with the science, and that is fine, we can respond to that, but 
when there is prejudice in the reviewer's mind in terms of 
scoring the significance or the impact of this research, it is 
not going get over the barrier.
    And right now NIH is really struggling to fund 
investigators. They are spreading the butter very thin, they 
are finding ways to cut here and there, pay lines are extremely 
high and very difficult hurdles to overcome. Young people are 
not entering science; old people like me are leaving. It is a 
difficult environment. It is going to take years to come out 
of. So in that environment it is a combination of things that 
anything controversial, be it Lyme disease or otherwise, is 
going to have difficulty getting funded.
    Mr. Smith of New Jersey. Thank you.
    Dr. Barthold, you also have made a recommendation that NIH 
publish a call, a specific call, for applications that request 
research on the biological significance of persisting 
spirochetes following antibiotic treatment. In making that 
call, I am sure this isn't the first time--or maybe it is--has 
there been any openness to that suggestion?
    Dr. Barthold. The only suggestion is mine in this 
testimony.
    Mr. Smith of New Jersey. Okay.
    Dr. Barthold. Our system works. We scientists are always 
looking for money, and we follow the money. And when NIH puts 
out a request for applications with a devoted pot of money to 
support that kind of work, you will get response from the 
scientific community. I think we saw a good example of that 
with biodefense funding several years ago where people left 
their traditional fields and went over into biodefense 
research.
    It is just a matter of opportunity. If NIH says, this is an 
important subject area that needs to be explored, then 
hopefully young people will gravitate to those opportunities.
    Mr. Smith of New Jersey. Let me ask you, Dr. Stricker, on 
page 2 of your testimony you point out that the investigation 
that was initiated by the attorney general of Connecticut, now 
Senator, Blumenthal found conflicts of interest and suppression 
of data in the guidelines development process. And then you 
point out that despite extensive evidence, IDSA review panel 
voted unanimously to uphold the flawed guidelines.
    Could you elaborate on that? Because, you know, I was one 
of those who for years asked that there be an investigation to 
potential conflicts of interest. Finally the attorney general 
took it up, I am sure because of local people and others who 
brought it to his attention.
    But, you know, if there is not confidence in the process 
and the transparency, it does erode a belief that this a 
completely on-the-up process, and the outcomes then are suspect 
if it has not been. But suppression of data, that is a very 
serious conflict of interest. We knew what they were with the 
insurance companies. Would you elaborate on that if you would? 
    Dr. Stricker. Well, the attorney general's investigation 
uncovered significant instances of suppression of data where 
only the IDSA viewpoint was accepted. Any conflicting or 
contrary viewpoint was rejected in terms of formulating the 
guidelines. And this was a systematic problem with these 
guidelines. The investigation--and the attorney general 
published his concerns, and that is available on the Web site 
of the attorney general.
    What happened after that was that IDSA put together a 
hearing to review the guidelines, and that hearing was entirely 
under the control of IDSA. It was organized by IDSA. They 
picked the members of the review committee. They picked the 
individuals who testified before the committee. They had a 
medical ethicist who basically excluded treating physicians who 
treat Lyme disease, which biased the proceedings significantly. 
And for all those reasons the committee then came down with a 
decision that even though these guidelines were flawed, they 
were okay, and they were acceptable. And that has just been a 
travesty.
    Mr. Smith of New Jersey. In your testimony you say, 
clinical testing for Lyme disease remains abysmal. Are you 
encouraged at all by Dr. Eshoo's testimony and some of the 
things he is doing?
    Dr. Stricker. I am very encouraged. I think we need these 
kind of sophisticated laboratory tests. I think this advances 
the science of Lyme testing. We need the NIH and CDC to be 
supporting this type of advance, and I think--I am very 
encouraged by his work.
    Mr. Smith of New Jersey. You went into great detail in your 
written statement about renewed interest in cell wall-deficient 
bacterial forms and biofilms. And perhaps others on the panel 
might want to speak to those issues. Because you also point out 
that to date no antibiotic treatment exists that targets 
biofilm formation.
    And, Dr. Barthold, in your statement you did talk about the 
issue of mopping up. I don't think that has been mentioned. You 
know, most lay people don't understand that the antibiotics 
don't take it all away; that the host, as you put it up, mops 
up those bacteria or whatever it might be. Could you elaborate 
on that, and you, too, Dr. Stricker? 
    Dr. Barthold. So, using the biofilm analogy, biofilm is a 
population of microorganisms, some of which are dormant. This 
is kind of a universal survival mechanism among bacteria and 
fungi across the world. It is not just a biofilm of a human 
situation. So those dormant, nondividing bacteria are 
universally tolerant to the effects of antibiotics because they 
are not dividing, they are not metabolically active. And so 
this is a survival strategy that has been going on for eons 
among microbial communities.
    So Borrelia is kind of akin to that in that we know during 
an early infection it is rapidly dividing and disseminating and 
quite susceptible to antibiotics, and we see the same things in 
vitro or in a culture tube.
    During persistent infection in the immune phase of the 
infection, there is a tenfold reduction of organisms in the 
hosts--and we are talking about animal model studies that are 
not human--and those organisms are nondividing and dormant. 
They are not necessarily in the formation of biofilms, but the 
analogy is there. They are not dividing, and, as a result, 
antibiotics can't touch them, and so they grow out and survive.
    But what is unique about Lyme disease organisms is that 
they grow out, but they can't be cultured. So they are 
genetically attenuated in some way, but further work is needed 
there. 
    Dr. Stricker. And I would add that there was an article on 
biofilms that was published last week that goes to the 
molecular mechanisms of that process, and Borrelia has the 
molecular machinery to make biofilms, and so that makes it very 
significant in terms of the survival of the spirochete.
    I would add that was cell wall-deficient forms or cysts are 
another mechanism by which the bacteria can persist, because it 
basically becomes dormant and evades the immune system and 
antibiotics by taking this cell wall-deficient form. That is 
something that we need to do much more research on, and right 
now it is not being done.
    Mr. Smith of New Jersey. In your testimony, Dr. Stricker, 
you point out that big pharma is watching, and that hopefully 
at some point they get engaged, as they have in the HIV/AIDS 
pandemic. I am wondering, with Dr. Eshoo there, who is working 
overtime on a better way of discerning whether or not Lyme 
exists in the individual without resorting to the antibiotic 
antibody reaction in the host, how close are you, Dr. Eshoo, to 
coming up with this new test? And if you could, why, in your 
view, are the big pharmaceutical companies not getting further 
involved in this whole issue since it affects so many people?
    Mr. Eshoo. Well, I think there are a couple of reasons 
here. One the reason for the big pharmaceutical companies is 
even though they still see this as a small-market opportunity, 
to get a test and a diagnostic approved through the FDA takes a 
lot of money, a lot of time and a lot of resources. And so that 
is a big barrier to entry right there.
    You also have, as we have heard, you know, a lot of people 
in the community saying, well, the current tests are adequate 
enough. And so that also acts as a barrier.
    I think we are getting closer to getting a diagnostic that 
we could--to push forward, you know, for a clinical setting, 
but there is a lot of work still to be done. We would like to 
increase the sensitivity even further. We think looking for the 
DNA or some other marker of the bacteria directly will help end 
a lot of the controversy, and particularly during that early 
treatment period, early in the infection, when the treatment 
with antibiotics seems to be the most successful. And if we 
could diagnose it--I mean, who wants to be infected with a 
bacteria for 3 weeks or more waiting for a test result to turn 
positive? So----
    Mr. Smith of New Jersey. Let me ask you, whoever would like 
to answer this, how many people at the Infectious Diseases 
Society of America are actually controlling the guidelines? You 
know, I have seen the list, you know, what Attorney General 
Blumenthal did with each of those individuals. But are there 
people outside of that panel that have say as to the 
guidelines, or is that it? And do people like Dr. Collins, 
Francis Collins, a very distinguished individual, NIH Director, 
I mean, do he and others take it upon themselves to say, hey, 
``What is wrong here?'' Why is this a persistent bone of 
contention, and so many reasonable people, heavily credentialed 
people like yourselves, who come forward and say, there is 
another view, and people are sick and not getting treatment 
they need? 
    Dr. Stricker. The Blumenthal investigation showed that 
there was a small group of about 14 individuals who controlled 
the IDSA program on Lyme disease. And it really is a very small 
group. The rest of the organization, the other 9,000 members, 
defer to that group. And that has been a big problem. And other 
organizations like the NIH and CDC defer to that very small 
group, and that has been a huge problem with Lyme disease.
    Mr. Smith of New Jersey. Let me ask Pat Smith, if you 
could, does your organization and do other Lyme disease 
nonprofits have established scientific or medical review 
boards?
    Ms. Smith. Yes, we do.
    Mr. Smith of New Jersey. Could you explain a little bit?
    Ms. Smith. Okay. Basically our organization and most of the 
major organizations have either a separate scientific review 
board, or they might have--we have what is called a scientific 
and professional review board. And what our organizations for 
the most part that I am familiar with do is we don't pay those 
people. They don't pay us. Nothing is done like that. But if we 
have issues that we need to address, and it is in their area of 
expertise, or we are considering funding research--we fund a 
significant amount of research. As a matter of fact, our 
research has been published and acknowledged in 25 different 
peer-review journals. So what will happen if we get a project 
in, and we need expertise in the area, we might call upon some 
of those people. And the other organizations that I am familiar 
with, the CALDA, or lymedisease.org, Time for Lyme, which is 
now the Lyme Research Alliance, they also will do the same 
thing if we need people in the field to help us.
    But we do not ourselves--our organizations are basically 
organizations, patients and families of patients, but we have 
the resources with these people, who kindly give of their time 
to help us to achieve our mission.
    Mr. Smith of New Jersey. Dr. Stricker, you testified that 
you have some 2,000 patients that you have taken under your 
wing and treated. What has been your takeaway from that huge 
patient number? And how far progressed are many of these people 
when they finally get to you? 
    Dr. Stricker. I think one takeaway is that it shows that 
the number of Lyme disease patients far exceeds what the CDC 
reports, that the CDC reporting system is inadequate in terms 
of, you know, reporting all the patients with Lyme disease. 
They themselves admit it may be tenfold higher in terms of than 
what they report.
    Many of my patients come to me with years of suffering and 
misdiagnosis, like you have heard from the other speakers. The 
gratifying issue for me as a physician is that about 70 percent 
of those patients--I know that about 70 percent will get 
better. And for a physician to have that kind of a response is 
really very, very gratifying, and it makes me sort of turn a 
deaf ear to the political controversy and go on and treat these 
patients, and it makes it a very rewarding thing to do.
    Mr. Smith of New Jersey. Could you elaborate a bit as to 
what that treatment entails?
    Dr. Stricker. Well, as you heard it, generally long-term 
antibiotics. These patients do not respond to short-term 
antibiotic treatment. Many of them have failed short-term 
antibiotics. When they come to me, many of them have not been 
diagnosed with Lyme disease, so they haven't even considered 
treatment, and generally it is long-term antibiotics.
    We published a study last year of patients with neurologic 
Lyme disease required an average of 6 to 12 months of 
antibiotic therapy to improve, for their neurologic symptoms to 
improve. That gives you a general idea of what kind of 
treatment is needed.
    Mr. Smith of New Jersey. Mr. Gibson.
    Mr. Gibson. Well, thanks very much, Mr. Chairman, and I 
have certainly found this event here to be very informative.
    I would like to take advantage of the panelists being here 
to seek their feedback. Clearly we are in wide agreement on 
everything here today. And so what I would ask is do any of the 
panelists know--or yourself--plan to apply for the money that 
we put in last year, the $8.75 million for research and for 
treatment and chronic Lyme is actually in the wording in the 
law. So I guess broadly I am interested in how we can be more 
effective.
    Is there something about the way--obviously we want to have 
more money, we know that, but is there something in the way we 
are wording the law and the language for the report that could 
be improved? And what about the RFP process; how can we provide 
better oversight to make sure that we get these monies to the 
right place?
    Dr. Barthold. Well, as I said before, we in the scientific 
community chase the money, and if you simply enlarge the pot 
for Lyme disease research and spend it on large programs and so 
on that have already pretty much been done, we get nowhere. So 
if we recognize collectively, if NIH leadership recognizes, 
persistence after antibiotic treatment as an issue, then a 
focused call for applications looking at the biology will 
attract everybody and probably some new insight instead of the 
just the old-school club of people that feed off of Lyme 
disease. So a more narrowly focused call for applications is 
appropriate if NIH program people are willing to do that. 
    Mr. Eshoo. Yeah, I would just like to concur with that 
statement. Even our research has been almost all supported by 
government grants, and research foundations and private donors. 
So it is really--you know, the field needs this support right 
now to get off the ground. And I think targeted RFAs that are 
specifically targeting areas of need and carefully worded so 
that we don't see, you know, a better serological test, for 
example, would be very beneficial. 
    Ms. Smith. I would like to say that, first of all, we would 
never apply per se for those monies because we don't perform 
research; however, I do believe it is extremely important that 
the wording has to be almost mandatory that these funds are 
going toward the chronic form of the disease no matter what it 
is called, because what has happened over the past number of 
years of my involvement is all the research funding, or a good 
percentage of it, is going to institutions and researchers who 
have basically addressed the same issues over and over, and 
they don't fit the patient population that needs the help.
    The patient population, as you have heard today, are 
people, within quotes, ``chronic Lyme disease.'' So we need to 
be able to define that in such a way that the moneys are--
actually go for that type of study, and it isn't awarded, as 
has happened sometimes in the past, that says for chronic 
research, and it ends up being for post-Lyme syndrome, which is 
certainly a totally different issue.
    Additionally I think that there is a pressing need for a 
Federal advisory committee. Most other major diseases have 
advisory committees on, by the way, which patients and 
advocates sit, and no one says anything bad about them. No 
offense, but they don't. And I think that their perspectives to 
this issue are very important. They are living these problems. 
They have a greater understanding, maybe not of the technical 
aspects, but how it is affecting them, and what kind of things 
need to be done to change that.
    So I think that you have to have patients, you have to have 
advocates, you must have the treating physicians. It is 
abhorrent to me that clinicians--it means nothing that they 
went to medical school. It means nothing that they have treated 
2,000 patients or 4,000 patients for this chronic Lyme disease. 
It is taken away. They don't have any validity.
    This is wrong. They are seeing reality. What is on a piece 
of paper is not necessarily reality; that is just people's 
perceptions of what they think about this, it is not what is 
happening. And I see from my seat what is happening to 
patients.
    And I think that the government can do this. I think they 
have done it with other diseases. It is not even difficult to 
do, it is not costly to do. And, quite frankly, I really don't 
understand why it hasn't been done, and it has not been for a 
lack of advocacy.
    Mr. Gibson. Thank you, and we will continue to work that, I 
can tell you.
    And then for Dr. Stricker, I am interested in hearing from 
the role of a mentor how in California you influence and try to 
expand Lyme literacy, particularly among newer doctors, but 
really all doctors, sort of--for those that even may be in 
midcareer, expanding their--enlightening them and expanding 
their understanding. 
    Dr. Stricker. Well, ILADS does have a preceptorship program 
where physicians can come and spend time in my practice and 
other ILADS doctors' practices to learn about diagnosis and 
treatment of Lyme disease and to learn how to treat these 
patients. That has been very successful. It is funded 
privately, and that has been a way of mentoring doctors who 
want to get involved with the disease.
    But let me make one comment, and that is that I currently 
have a position in my practice for a Lyme-treating physician. I 
really cannot find anyone who is willing to take that position, 
and the reason is that with all the controversy around Lyme 
disease, doctors are basically unwilling to get involved in 
that controversy. And that controversy has really had a 
chilling effect on the mentorship and the development of 
physicians who can treat the disease.
    Mr. Smith of New Jersey. Follow up on that. Is that because 
they might be censored by the State medical board?
    Dr. Stricker. Absolutely. There is always that fear. I 
mentioned that in California we do have a physician protection 
law, but certainly censorship by medical board, censorship by 
your colleagues and by infectious disease experts is definitely 
a deterring factor in terms of doing that.
    Mr. Smith of New Jersey. Let me ask the entire panel, if I 
could, how would you would react to that statement, and it was 
recently made, and it is very important if I could get your 
feedback from it: ``There is no solid evidence despite many 
efforts that persistent infection occurs in humans following 
recommended treatment regimen.''
    Dr. Stricker. Well, let me mention that in my written 
testimony there is a table that lists 27 studies that show 
exactly that persistence infection following accepted IDSA-type 
treatment for Lyme disease. And actually I realize that I 
hadn't updated that table in a couple of years, so there are 
probably more studies now that show that. It is table 2. And 
that complements the other table, which is studies in animal 
models, that Dr. Barthold can address, that show basically the 
same thing.
    Mr. Smith of New Jersey. Thank you.
    Dr. Barthold. I have little to add, but working and making 
guesses at how to treat people will only get us so far, and I 
am a believer in basic biology studies. We need to understand 
what is going on with Borrelia in the mammalian host, be it a 
mouse, or a dog, or a primate or a human. Human studies are 
very difficult to do, and so animals allow us to extrapolate 
those findings.
    A lot of people are using the animal models, including the 
mouse model that I developed years ago, in their research, but 
they are all looking at the early phase of the infection when 
spirochetes are disseminating and causing acute inflammation 
and so on. And I am not aware of very many people that are 
looking at chronic persistent infection and the mechanisms by 
which Borrelia evades postimmune clearance. There may be less 
than five laboratories worldwide studying that phenomenon, and 
yet that is the most important aspect of this disease.
    Mr. Smith of New Jersey. Ms. Huyshe-Shires, did you want to 
comment on that? 
    Ms. Huyshe-Shires. Just to corroborate what other witnesses 
have said, but there are well-documented cases of patients from 
whom Borrelia have been isolated after antibiotic treatment who 
were still symptomatic, still following further perhaps long-
term antibiotics, then did recover. It is a very disputed area, 
and until, I think, everybody gets down together to actually 
decide on what facts we are uncertain, then we won't move 
forward.
    Mr. Smith of New Jersey. Thank you.
    Ms. Huyshe-Shires, you mentioned in your testimony European 
guidelines for neurological Lyme disease; can you clarify where 
those guidelines were developed? Are they more flexible that 
the Infectious Diseases Society of America guidelines, and are 
those guidelines accepted in the UK?
    Ms. Huyshe-Shires. The guidelines are accepted in the UK. 
They are not so much more flexible, but they state more clearly 
the uncertainties. So there are summary recommendations.
    But the guidelines got drawn up by the European Federation 
of Neurological Societies. These guidelines state on what basis 
they are drawn up, and they make the point that for 
neurological Lyme, there have been no good-quality European 
trials more than 28 days. So although they recommend 21 to 28 
days' treatment in neurological Lyme, they say that this is 
based on a good practice and opinion, because there haven't 
been any trials to say whether that it is better--whether a 
longer course, 35, 40 days, would be better.
    And, in fact, the studies that they quote, or the trials 
that they quote, you can see that the response rate varies from 
about 20 percent, 30 percent to 100 percent. They are often 
trials which show a good recovery for that short period, but 
most of them around about in the 50-, 70-percent response. Now, 
often clinicians quote trials and say European trials show an 
excellent response rate. A patient would not consider 7 out of 
10 people responding to treatment as being excellent.
    Mr. Smith of New Jersey. Thank you.
    Ms. Smith, you mention in your testimony that children are 
at the highest risk of acquiring Lyme. Can you describe the 
consequences to children who contract it? I know your own 
children, two of them, have suffered the devastating impact of 
Lyme. Could you speak to that, please?
    Ms. Smith. Yes. The effects on children are I am going to 
say more devastating in some ways, because, first of all, they 
are kind of defenseless oftentimes, and they can't articulate 
the kinds of symptoms that they have. So what happens, not only 
do they have the medical complications which are obviously very 
serious, but they also are greatly impacted about what their 
peers, their schools, their teachers are saying about them.
    My own daughter was out of school for over 4 years on home 
instruction, and I was a board of education member. And I am 
not going to tell you that it wasn't appalling to me at 
comments, you know, that were made that my daughter was trying 
to get out of school, that she wanted to stay home. And I 
finally said to someone, excuse me, but what 15-year-old wants 
to stay home with her mother for 4 years, and what mother wants 
to have her 15-year-old home for 4 years?
    But I guess the bottom line is the research studies that we 
have seen out of Columbia and other institutions have shown 
that these children benefit greatly from long-term treatment, 
and that oftentimes the short-term treatment really doesn't 
help them, and sometimes maybe it hurts them, because it may 
stop immune response, they may not get a positive test, which 
then brings them down even further, because less people now 
believe them in the scheme of things. And so it is very hard 
for them, it is hard for their families.
    And, you know, I mentioned the Munchausen's by proxy, and 
the reason I mentioned that is because I think that shows the 
extremes that some people and physicians will go to to, you 
know, make a point that there is no chronic Lyme disease, that 
these moms should not be having their children treated by 
licensed physicians with antibiotics--we are not talking about 
other types of medications. And here what is happening in many 
States across the country has happened already where the local 
family services departments will come in--and I have seen this 
happen--where one child is being treated for chronic Lyme, yet 
they will take away all the children from the mother. And this 
is abhorrent to me, and I don't understand how in this century 
that this is still happening.
    And I would be remiss if I didn't mention, Congressman 
Smith, that you intervened in New Jersey for us for a mom that 
was having that happen. So I think that you know personally 
that this is serious.
    And our kids are psychologically damaged. That is why there 
is a high rate, relatively high rate, of suicides among Lyme 
patients in general and children--or I should say suicide 
attempts. Fortunately they are not always successful. But I 
have been there with those moms when their children--after they 
have committed suicide, and it is the saddest thing in the 
world to me that we have the tools, we have the knowledge in 
this great country that we could put a stop to this.
    Mr. Smith of New Jersey. Mr. Huyshe-Shires, can I just ask 
you when the Infectious Diseases Society of America came under 
fire from the attorney general from Connecticut, did that cause 
pause and perhaps some reflection on the part of Europeans as 
well as people in the UK about the accuracy of what their 
recommendations were all about? I mean, did people say, wait a 
minute, this small subgroup of people have been found to have 
conflicts of interests and suppression of evidence and 
information. Did that cause anyone to say, let's do our own 
work on this?
    Ms. Huyshe-Shires. Unfortunately not. There was a strong 
belief, as I have mentioned, that the expertise tended to be 
vested in really one, two or three people in the UK, and 
therefore people believe those few people. And because they 
have been engaged with the IDSA 2006 guidelines, they carried 
on supporting IDSA, and therefore everyone believed that there 
wasn't a problem with IDSA. And, in fact, when the panel 
reported that they recommended some changes to the IDSA 
guidelines, and that Europe should be considered slightly 
differently, this was reported in the UK as a confirmation that 
IDSA guidelines could not be changed.
    So in this country, as far as the official NHS goes, there 
was no change at all, and no one recognized that IDSA had 
actually pointed out that there should be a few changes made.
    Mr. Smith of New Jersey. Let me ask Mr. White--and I just 
have two more questions, and anything anyone would like to say, 
and if you have any final questions or comments. What would be 
your advice to those who have chronic Lyme disease symptoms but 
have not located a doctor as yet? What do you recommend to 
them?
    Mr. White. Well, I think they actually need to do the same 
thing that my family did, and that is be as resourceful as 
possible, and dedicated to getting all the information that you 
can, and searching out the people like Pat Smith who can lead 
them to a knowledgeable physician that will give them effective 
treatment.
    Mr. Smith of New Jersey. Ms. Smith, you mentioned the 
importance of having an agency, interagency, a coordinating 
committee that would include patients, clinicians and the like. 
I started out this hearing noting that I introduced two bills 
almost at the same exact time that had very similar components, 
including one was for autism and one was for combating Lyme. 
The autism became law. We now have the IACC, or the Interagency 
Autism Coordinating Committee, led by Dr. Insel.
    Just last week I joined others testifying before them, 
speaking to them about latest advances in combating autism. And 
you have patient groups, you have people of all walks in the 
room, diverse opinion, some who think that thimerosal is the 
cause of autism, and all of it is being treated very seriously 
to try to get to causation as well as the best way to mitigate 
that horrific developmental disorder.
    I am shocked and dismayed by the inability to do the same, 
I introduced almost identical bills, put the bills side by 
side, we borrowed ideas from both, including a task force and 
interagency with people of diverse opinions to try to really 
get to the bottom of this. I will remind everybody, we invited 
the Infectious Diseases Society of America to be here to 
testify, as well as NIH and CDC. That invitation stands. 
Hopefully they will get back to us so that we can continue this 
dialogue. But why contrary opinion is so frowned upon is 
beguiling to me.
    And I would just say parenthetically I served on the 
Veterans' Affairs Committee for most of my time in Congress. I 
have been in Congress for 32 years. The first amendment--it 
wasn't my amendment, but I was a cosponsor of it--that Tom 
Daschle offered was on Agent Orange, and it failed. And we know 
the evidence clearly supported service-connection presumption 
disability for those suffering from Agent Orange. Years later I 
am the one who held the hearings and offered legislation that 
became law on the Persian Gulf illness, which was attributed to 
stress rather than some other trigger which we know or believe 
is the cause.
    This inability to say, welcome all sides, so that we can 
get to the bottom of this is, like I said, beguiling. If any of 
you want to speak to that, I would surely like it, and I would 
like to ask as well my good friend Mr. Gibson if he has 
anything, and then final words go to you.
    Mr. Gibson. Well, let me just wrap up by saying that, you 
know, I deeply appreciate your leadership. You have taken us 
far, very far, on these issues that you listed. I am the author 
of a bill right now to make sure that we get presumptive 
coverage to our Navy veterans who are serving offshore who have 
been exposed to Agent Orange and now have to fight to get that 
kind of coverage.
    Now, we do win some of those cases. Even in the 1\1/2\ 
years I have been in the Congress, we have helped win these 
cases. But they should get presumptive coverage. And, in fact, 
through desalinization, they are exposed to 10 times more 
powerful from Agent Orange. That that was the kind of exposure 
they had from being offshore.
    So the passion that you have brought to these afflictions 
that we bring forward and the treatment that is necessary is 
deeply appreciated. We are going to continue to work this. We 
will be indefatigable on this issue, and we will work to bring 
forward the appropriations necessary so we get the research so 
that we get a better test. If we get a better test, then we get 
better treatment and ultimately change the guidelines, the CDC 
definitions, because we know, or at least we have been told, 
that insurance companies will then follow. And that is part of 
this equation, as well.
    So thank you. I appreciate all of the panelists for what 
they have contributed here today and, Mr. Chairman, for your 
leadership. I yield back.
    Mr. Smith of New Jersey. Mr. Gibson, thank you so very much 
for your leadership.
    And if anyone would like to make a final comment or 
suggestion, this would be the time.
    Dr. Stricker. I would also like to echo the gratitude to 
the chairman for organizing this hearing, and just to say once 
again that we need a more comprehensive program for Lyme 
disease. We need better animal studies funded by the 
government. We need better diagnostic testing research. And we 
need better clinical trials to see how to treat Lyme disease, 
what the best way is to treat these patients.
    Ms. Smith. In closing, I would particularly--besides 
thanking the committee--I would like to address those agencies 
in absentia, if you will. And I just want to say that advocacy 
groups that I work with all across the country, you know, they 
are really not adversarial. They are not adversarial at all. 
The people involved in them are fighting for their very lives.
    And so, these agencies forget. They are up there, and they 
are sometimes well-meaning; the bureaucracy gets in the way. I 
know, I was a school board president. I know about government 
bureaucracy. However, there comes a point in time when they 
have to stop, they have to look at the statistical data, they 
have to look at the reality, they have to talk to the treating 
physicians, they have to accept the patients and the advocates 
as being able to be part of this process, not as them being 
adversaries, but in sitting across the same table.
    I don't have to agree with you. I have been married 44 
years. I don't always agree with my husband. Once in a while, 
we disagree. And so the point being is, it is not about that. 
It is about sitting down and discussing, ``Guys, what can we do 
about it? How can we help these suffering patients?''
    And so that is why I came. That is why I have devoted most 
of my latter life, you know, to doing this. I don't have any 
agenda other than that. And I would ask that they recognize 
those things about the patients and advocates. And, please, you 
know, sit with us. Let's forget all this, and let's move 
forward as to how can we get help for patients in this country 
and across the world.
    Thank you.
    Mr. Smith of New Jersey. Yes, Mr. Eshoo?
    Mr. Eshoo. I would like to expand on a point. I think, you 
know, good science will really help bring this community 
together on the same page.
    And, you know, I grew up in the San Francisco Bay area. And 
if you look back in the 1980s when the HIV outbreak was coming 
out, there was all kinds of hysteria associated with what was 
this coming from, how was it transmitted, what were the causes 
and sources. And, really, what shed a lot of light was good 
diagnostics. Suddenly now we could reliably tell, who had it, 
how it was transmitted, and the science behind the various.
    And I think that is really what Lyme disease needs, too. 
And I think, you know, some of the animal studies are 
especially relevant for these kinds of questions that we have 
in understanding the biology of this infectious agent. And good 
science will, I think, bring everybody together.
    Dr. Barthold. I just would like to summarize.
    My career with Lyme disease started way back with Allen 
Steere in Connecticut. These are good people. People on the 
IDSA report are good people. The lay community are good people. 
But I am very saddened by the contentiousness that has evolved 
with this disease. People are backed into corners and 
protective. And I think we need to have open dialogue where 
everybody hugs and kisses and gets along. Because we all have 
the same goal, and that is to improve human health.
    And, as a veterinarian, I will say veterinary species, as 
well, are afflicted with this disease.
    Mr. Smith of New Jersey. Mr. White or Ms. Huyshe-Shires, do 
you have any final comments before we conclude?
    Ms. Huyshe-Shires. I would just like to agree with what 
most of the witnesses have said. We do need to work together. 
We need to come out of any entrenched positions. And we do need 
to get to the bottom of the science. We are improving our 
science all the time. And there is a lot to learn about Lyme 
disease. We do not know it all.
    Mr. White. I would just like to add that, you know, I 
absolutely echo everyone's sentiments, but I just want to put 
it in context, the fact that this has been a long time running 
and so such of this sounds very familiar to me from when I was 
much younger. And I think that that shows that it is time, that 
it is time for people to kind of get together, for everyone to 
kind of show their cards and, really, to act in the best 
interest of the collective community.
    I don't, like you, understand what the basis is for this 
contentiousness when, clearly, so many people are being harmed 
at this point.
    Mr. Smith of New Jersey. On that last word, thank you so 
very much.
    The hearing is adjourned.
    [Whereupon, at 4:08 p.m., the subcommittee was adjourned.]
                                     

                                     

                            A P P E N D I X

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     Material Submitted for the Hearing Record




   Material submitted for the record by the Honorable Christopher H. 
 Smith, a Representative in Congress from the State of New Jersey, and 
   chairman, Subcommittee on Africa, Global Health, and Human Rights





                                 
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