[Congressional Record (Bound Edition), Volume 158 (2012), Part 9]
[Extensions of Remarks]
[Pages 12063-12065]
[From the U.S. Government Publishing Office, www.gpo.gov]




            LYME DISEASE EXPLODING IN U.S., AROUND THE GLOBE

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                         Tuesday, July 24, 2012

  Mr. SMITH of New Jersey. Mr. Speaker, last week I chaired the 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 the witnesses we had last week, Pat 
Smith, attended one of my townhall 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 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 things in mind--
detection, improved surveillance and reporting, accurate diagnosis and 
physician knowledge.
  I reintroduced the bill again in 1999, 2001, 2004, 2005, 2007, 2009 
and 2011.
  I would note parenthetically that that same year, I also introduced a 
comprehensive law to

[[Page 12064]]

combat Autism. Despite significant opposition in Congress and at NIH 
and CDC that paralleled the Lyme bill struggle, it 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 NIH and CDC. 
If only we had done the same with Lyme Disease legislation in the late 
90s--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 a Lyme-
literate physician--I have been dismayed and 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 with the requirement of ensuring diversity of valid 
scientific opinion--a ``broad spectrum of viewpoints''--on the 
committee.
  In Europe, Lyme disease syndromes were described as early as 1883, 
and by the mid-1930s neurologic manifestations and the association with 
Ixodes ticks were recognized and known as tick-borne 
meningoencephalitis.
  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 Allen Steere, MD, 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, 
Ixodes scapularis.
  Lyme disease is the most common vector-borne illness in the U.S. 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 U.S., Lyme disease has been reported in 49 states 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 Centers for Disease Control and Prevention, CDC, in 2010, making it 
the 6th most common reportable disease in the U.S. and the 2nd 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 new cases in 2010 alone. About 85,000 cases were 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 (or B. burgdorferi); in Europe, B. burgdorferi and 
at least four other species of Borrelia cause the disease. Different 
species are associated with different manifestations of disease. There 
also 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. According to the 
U.S. Army Surveillance System--which may have a greater variety of 
systems because they have both domestic and international surveillance 
components--during the first stage, 70 percent of patients display the 
characteristic erythema migrans (EM). Other symptoms of stage one 
include profound fatigue, fever, chills, headache, sore throat, sore 
and aching muscles and joints, and swollen glands.
  The second stage is marked by migratory musculoskeletal pain, 
neurological complications in 10-20 percent of patients, and heart 
inflammation or heart block in 6 to 10 percent of patients that appear 
4 to 6 weeks after infection. Symptoms include severe headache and 
stiff neck, facial paralysis, weakness and/or pain of the chest or 
extremities, rarely optic atrophy with blindness and coma. 
Acrodermatitis Chronics Atrophicans, ACA, is a cutaneous manifestation 
that may occur during the second stage to several years after disease 
onset.
  The third stage typically involves the onset of arthritis 
characteristic of rheumatoid arthritis, affecting primarily the knees 
and other large joints. During this stage, a small percentage of 
patients also suffer from sleepiness, loss of memory, mood swings, and 
an inability to concentrate.
  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 cites 
scientific evidence to support its claims, while outcomes research is 
limited and conflicting. One view--promoted by the Infectious Diseases 
Society of America (IDSA)--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 Diseases Society, ILADS, 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 can be one or more causes of 
persistent symptoms after initial treatment in an individual who has 
been infected with the agent of Lyme disease. These causes include the 
possibility of persistent infection, or a post-infectious process, or a 
combination of both. These are not ``academic'' concerns however 
because the patients' health is at stake. Unfortunately, some academic 
researchers believe 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 persistence of Borrelia, and available 
treatment options in light of clinical guidelines.
  Current diagnostic tests commonly used do not detect the spirochete 
that causes Lyme disease, rather, they detect whether the patient has 
developed antibodies to the pathogen (serological testing). CDC 
recommends two-tier serological testing, but cautions that the 2-tier 
system should 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 
high variable sensitivity and specificity further puts the much-
advocated two-tier testing strategy into question.''
  In addition, two of the authors of a July 3, 2007 article on an 
antibiotic resistance element in B. burgdorferi, were Julie Boylan and 
Frank Gherardini of NIAID's Rocky Mountain Laboratories, stated that, 
``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 told us last week of exciting 
information regarding the development of diagnostic tools that, 
hopefully, will move us past a lot of the controversy.
  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 B. burgdorferi after 
treatment with antibiotics. There are numerous documented case studies 
of persistence in humans after antibiotic treatment, and our witnesses 
may comment on additional evidence for post-treatment persistance in 
humans. Additionally, one of our witnesses from last week's hearing was 
Dr. Stephen Barthold, one of the top experts in the country, and I am 
sure in the world, on animal models. Dr. Barthold, described published 
and yet to be published experimental studies that provide compelling 
evidence for B. Burgdorferi persistence following antibiotic treatment 
in animal model systems and their potential significance for human 
medicine.
  Numerous studies have been conducted of the mechanisms 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 B. burgdorferi, including cell wall 
deficient forms and biofilm-like colonies. Research also indicates that 
Borrelia can exchange genetic material, possibly contributing to its 
ability to avoid detection by the immune system. Several other distinct 
technical mechanisms are well known by which Borrelia can evade the 
immune system.
  Contrary to known scientific evidence, in a March 21, 2008, letter to 
Members of Congress, IDSA stated, ``Not only is this assertion [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 IDSA 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 the October 4, 2007, New England Journal

[[Page 12065]]

of Medicine, several IDSA physicians and a CDC colleague made the 
statement that ``Chronic Lyme disease, 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 IDSA'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.
  Supporters of the IDSA guidelines point to dangers of the prolonged 
use of antibiotics and the possibility of treating when an infection 
has not been established. They also frequently point to alternative 
therapies which are unproven and may be dangerous; however, such 
alternative therapies are in the background for many diseases--perhaps 
most well recognized for cancer. Critics of the guidelines contend that 
they are based on highly selective science and that guidelines 
panelists had significant conflicts of interest. A 2009 review of the 
IDSA guidelines did not result in any changes.
  IDSA and supporters place heavy weight on certain clinical trials of 
Lyme treatments supported by NIH. There has been much controversy of 
the quality of those trials and their generalizability to broad 
populations of patients. It is disturbing to the lay bystander that the 
controversy has ensued for so long without resolution. Certainly there 
are numerous unknowns about the bacteria and the disease; however, the 
public questions why the ``experts'' can't even agree on whether these 
small numbers of clinical trials are well designed, well executed, and 
of sufficient power (whether they have a large enough number of 
patients), and the degree to which they can be generalized to other 
patient populations.
  IDSA supporters have been adamant in the quality of the studies and 
the validity of their use to guide treatments for broad patient 
populations. In fact, several other researchers have been highly 
critical of the studies, pointing to specific perceived deficiencies, 
such as selection criteria that almost guaranteed failure, not 
appropriately defining endpoints, and, significantly underpowering the 
studies. One journal article from the Netherlands states, ``The 
randomized studies that have been performed have been of questionable 
quality and were heavily underpowered to detect potential effects.''
  Many who recognize the shortcomings of clinical trials to date, 
stress the importance of conducting more well-designed treatment 
studies with a sufficiently large and representative number of 
patients, and at least some such efforts are underway around the globe. 
I am pleased that Dr. Raphael Stricker, a practicing physician who sees 
many Lyme patients, guided us through some of the vast amount of 
literature on Lyme disease.
  The UK has suffered under a contentious environment among different 
Lyme disease stakeholders very much like that of the U.S. We are told 
however that the UK may be making progress in developing a more 
cooperative environment. I am pleased that Stella Huyshe-Shires, the 
Chairman of Lyme Disease Action, in the United Kingdom, was able to 
share with us some of the perspectives on efforts to manage Lyme 
disease in Europe. I was happy to hear about the collaboration, funded 
by the National Institute for Health Research, with the Jack Lind 
Alliance to identify the uncertainties faced during consultations 
between patients and physicians, to then identify the top unanswered 
questions about diagnosis and treatment of Lyme, and to prioritize 
research.
  This cooperative approach contrasts with the environment in the U.S. 
A recommendation regarding Lyme disease made during a May 2005 meeting 
of CDC's National Center for Infectious Diseases Board of Scientific 
Counselors, attended by the then President of the IDSA, that CDC should 
focus on science and not on the concerns of patient groups and that 
others may need to step in to assist CDC with public interface. 
Collaboration between the IDSA and government agencies on strategies to 
deal with the public can be seen in various statements and documents.
  The September 2011 article, ``Antiscience and ethical concerns 
associated with the advocacy of Lyme disease'' reflects the degree of 
hostility toward patients, treating physicians and the Lyme charities 
that were formed to support education and research on behalf of 
patients.
  Wouldn't it be much better if instead of belittling, insulting, and 
smearing patients, treating physicians and advocates, the authors of 
that study had asked themselves and posed the question to others ``What 
can we do to better understand and address the needs and concerns of 
patients, physicians and advocates?''
  Two of the witnesses we heard from last week focused on the needs and 
concerns of patients and the non-profit organizations fighting on their 
behalf--namely, Mr. Evan White, a former Lyme disease patient, and Ms. 
Pat Smith, the President of the Lyme Disease Association, who provided 
their important perspectives. What we should never lose sight of is 
that the goal of all of our efforts and the science is to help patients 
regain health.
  There are numerous Lyme disease non-profit organizations, some of 
them less informed than others. To cast a wide net and say that that 
they are well-intentioned, but ignorant and ill-formed is not an 
accurate portrayal. Many of them are intelligent, savvy people, who 
established medical and scientific advisory boards to advise their 
organizations. Two that I am most familiar with have funded millions of 
dollars in Lyme disease research, providing grants to a Who's Who of 
Academic Researchers.
  Efforts to discredit research because it was partially funded by Lyme 
disease charities are therefore disturbing. Such efforts led some 
researchers to initially submit research studies and to leave off some 
funding sources. Researchers have also reported that when they have 
presented research findings to government officials or other 
scientists, there has been more interest in the funding sources than 
the research itself. Without speculating whether such intimidation is 
intentional, it is most unfortunate because academic scientists and 
very critical studies have been, and continue to be, supported by 
several of the Lyme charities, some of whom have raised millions of 
dollars and have invested every penny into research.
  At the end of their ``Antiscience. . . .'' tirade, the article's 
authors state that the public's health will be endangered ``unless 
responsible physicians, scientists, government leaders, and the media 
firmly stand up for an evidence-base approach to this infection that is 
based on high-quality scientific studies.''
  That is a perfect ending for my remarks because that is precisely 
what the Lyme community wants; however, it will be necessary for the 
physicians, scientists, government leaders, and media to be 
discerning--to evaluate the evidence to see if it is based on the best 
science and to scrutinize the studies and the critiques of those 
studies to determine whether they are of high quality. We need 
scientists to speak out in an unfettered way. We need government 
agencies to show leadership and to forcefully say what we know and what 
we don't know based on the best available evidence.
  Thankfully, we can be confident that science will prevail: research 
has been progressing--we are greatly increasing knowledge of 
pathophysiology, and we seem to be on the cusp of breakthroughs in 
diagnostics that hopefully will solve questions of persistence and 
active vs. past infection.
  I regret that we did not hear from NIH, CDC, nor a representative 
from the IDSA at last week's hearing. They all were invited, but 
declined--the IDSA expressing that their potential witness had a 
scheduling conflict.
  I will reissue an invitation to them--and expect they will testify 
before our subcommittee.

                          ____________________