[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