Mr. Speaker, Patricia Smith, a constituent of mine from Jackson, New Jersey and the President of Lyme Disease Association, Inc., LDA, recently testified before the House Energy and Commerce Health…
Mr. Speaker, Patricia Smith, a constituent of mine from Jackson, New Jersey and the President of Lyme Disease Association, Inc., LDA, recently testified before the House Energy and Commerce Health Subcommittee regarding the need to establish an advisory committee on Tick-Borne Diseases. I would like to submit her compelling testimony from the hearing, entitled ``Examining Public Health Legislation to Help Local Communities,'' for the Record:
Chairman Pitts and Committee Members, Thank you for
allowing me to testify on the need to establish an advisory
committee on Lyme disease to ensure that government resources
are being appropriately used to move forward the field of
science and treatment in an area that is fraught with
political, scientific, and medical obstacles, yet is
dominating discussion on the worldwide stage. In 2009, the
Centers for Disease Control & Prevention (CDC) indicated that
Lyme surpassed HIV in incidence followed by a 2013
announcement confirming a 10-fold under-reporting of Lyme
cases, estimating 300,000 Lyme cases annually. A 2001
National Institutes of Health (NIH) sponsored study found
that the impact of Lyme disease on physical health status was
at least equal to the disability of patients with congestive
heart failure or osteoarthritis, was greater than those
observed in type II diabetes or in recent myocardial
infarction, and chronic pain contributing to impairment was
similar to that reported by patients with osteoarthritis.
Couple those facts with Lyme spreading worldwide to 80
countries and the discovery of many newly emerging tick-borne
pathogens being carried by many different ticks, then the
passage of HR 610 is long overdue.
The LDA just revised its comprehensive education and
prevention brochure, LymeR Primer, which went from featuring
7 tick-borne diseases (TBD) in 2009 to 15 diseases. Besides
Lyme disease, there are at least 15 other TBD of concern in
the US: anaplasmosis; babesiosis, bartonellosis;
ehrlichiosis; Rocky Mountain Spotted fever; Colorado tick
fever; Q fever; tick paralysis; tularemia; Powassan
encephalitis; STARI, a Lyme-like disease often with the same
rash, transmitted by a lone star tick bite, pathogen cause
unknown, but may be a bacteria similar to the Lyme bacteria;
Rickettsia parkeri Ricketsiosis found increasingly along the
Gulf Coast and in the South; Borrelia miyamotoi, a tick-borne
bacteria which had been producing disease outside the US, now
found in the US; newly found Ricketsia species 364D in the
Pacific Region; and a newly discovered tick-borne virus in
Missouri, Heartland, carried by the lone star tick. One tick-
bite can give someone more than one disease.
My education on Lyme began almost 30 years ago as a NJ
Board of Education member whose district had a large number
of students and staff out with Lyme disease. Then, only a few
US ticks were recognized as major health threats to humans.
Now, many ticks in the US are causing more human diseases,
ticks including Ixodes scapularis (deer, black legged),
Amblyomma americanum (lone star), Dermacentor variabilis
(American dog), Dermacentor andersoni (Rocky Mt. wood),
Ixodes pacificus (western black legged), Amblyomma maculatum
(Gulf Coast), and Dermacentor occidentalis (Pacific Coast).
My Lyme work, including 17+ as president of the national
volunteer-run non-profit Lyme Disease Association (LDA), has
kept me in close contact with patients nationwide. The
complicated nature of Lyme disease, the difficulty in
diagnosis, and lack of recognition by some in the medical
community have exacerbated the plight of patients and their
families, many of which contain more than one Lyme victim.
Medical bills rise; jobs are lost; education is interrupted.
Divorce is not an uncommon result in these families, further
complicating the picture. Often, the families are forced to
seek government help, government which is already burdened
with more debt than it is able to handle.
Children have always been at the highest risk of acquiring
Lyme disease. Based on CDC's Lyme reported cases numbers from
2001-2010 by age, LDA estimated that 37% of reported cases
were children. Using 1990-2011 CDC reported numbers adjusted
for 10-fold underreporting, LDA found that 1,590,449 children
have developed Lyme disease over that period. Many more
children were probably clinically diagnosed but not included
in the CDC surveillance figure, which uses a strict reporting
definition not meant for clinical diagnosis. These are
children who often go on to develop chronic Lyme disease--who
often miss months/years of school and have their childhood
destroyed. Showering, walking, talking, thinking can be a
problem, and serious pain is a daily challenge. A 1998
Columbia University study documents improvement in IQ of 22
points in a 16 year-old after IV treatment for Lyme disease.
A 1992 CDC/NJ Department of Health study in NJ of 64 school
children with Lyme showed that the median duration of Lyme at
time of interview was 363 days; the median number of days the
illness was said to have significantly affected normal
activities was 293; the mean number of total school days lost
was 140; the mean duration of home instruction, 153 days.
Only 26% of children under study were said to have fully
recovered.
The direct medical costs per case incurred by 54 case-
patients totaled $5.2 million, $8.7 million in CPI adjusted
2013 dollars. The mean estimate was $96,569 ($274,412-2013);
and costs of $100,000 ($166,891-2013) or greater were
incurred by more then 1/5 of children. Some indirect costs
were assessed totaling about $15,000 ($ 25,034-2013) due to
lost time caring for patient and parents' lost time
transporting children to medical treatment.
A 2001 Columbia study showed children with Lyme disease had
significantly more cognitive and psychiatric disturbances.
Cognitive deficits were still found after controlling for
anxiety, depression, and fatigue. Lyme disease in children
may be accompanied by long-term neuropsychiatric
disturbances, resulting in psychosocial and academic
impairments. Regarding depression, parents indicated that 41%
of children with LD had suicidal thoughts, 11% had made a
suicide gesture.
Early intervention and appropriate treatment are the
answers for patients with Lyme to prevent the development of
chronic Lyme disease, aka, Post Treatment Lyme Disease, late
disseminated Lyme, persistent Lyme, Post Lyme Disease
Syndrome, etc. While discussions continue on the
justifications for the various terms used for chronic Lyme
disease, we cannot allow the semantics to eclipse the need
for research on chronic Lyme, the area producing the most
human suffering and receiving the least research funding.
According to a new Columbia University Lyme study, based upon
10-fold underreporting and on 10% of newly infected and
treated patients developing symptoms that persist for more
than 6 months, ``the actual incidence of new chronic cases
(PTLS) is . . . 30,000.''
Currently, many major health threats including chronic
fatigue have an advisory committee. Lyme disease does not,
placing its patients and advocates at a great disadvantage.
We have lobbied for a research agenda which includes more
effective treatments for Lyme and other TBD and better
diagnostics, including detection of active infection. B.
burgdorferi was recognized in 1981 to cause Lyme, almost 33
years ago, yet the two-tier testing system endorsed by CDC is
very specific for Lyme disease (99%), so it gives few false
positives, but according to some sources, the tests have a
uniformly low sensitivity (56%)--missing 88 of every 200
patients with Lyme disease. Yet HIV was identified as the
cause of AIDS in 1984, and tests were developed within a few
years after and are 99% sensitive and specific. Moreover,
Lyme has not attracted industry funding for treatment
approaches, which has allowed patients to develop severe
mental and physical disabilities from the disease without
help from science. There is also a need for educating doctors
and the public about the state of the science regarding these
diseases.
The above agenda requires the establishment of a venue
where government agencies working on diverse aspects of tick-
borne diseases (e.g., CDC surveillance, testing; NIH research
funding-clinical trials, as well as basic and translational
research; FDA drug, vaccine and device approvals; USDA
research into natural tick prevention strategies; EPA tick
prevention strategies) can present their activities, submit
their proposed TBD agenda, and receive input from committee
members who represent a wide variety of stakeholders with
diverse scientific viewpoints on development of new
diagnostics, treatment methods, and prevention strategies.
Utilizing this format, government would ensure its agencies
were providing the most judicious use of human and
financial resources for Lyme and TBD. Using an already
established federal advisory committee format ensures that
the committee is only advisory in nature--committee
members would not control nor dictate agency agendas, a
concern that has been expressed by an outside group in the
past. However, those agencies should not be insulated from
the public input and diverse scientific viewpoints this
committee would provide in shaping an agenda and ensuring
the wise use of tight federal dollars, which are provided
by taxpayers. Another concern might be whether an advisory
committee is worth the costs, including time, to support
the operation of the committee. In the case of Lyme
disease, the history of the past decades should lead to an
easy yes.
One does not have to be a scientist to realize that it is
premature and unwise to preclude further clinical trials
studying a broader range of treatment regimens when there are
numerous major and significant aspects of the bacteria's
known pathophysiology which have not been accounted for in
studies conducted to date, when there are still many unknowns
in that pathophysiology, and when we are learning more every
day. While our knowledge of the pathophysiology of the
bacteria continues to evolve, we must be open to additional
clinical trials to document and establish better treatment
regimens. There is preliminary evidence for more effective
regimens, and a specific forum for open dialogue can help
ensure we move forward and don't get waylaid.
An open dialogue also could only improve the process of
utilizing the pool of competent researchers--not in any
manner that would interfere with established fair and open
processes for grant-making, but only to increase awareness.
It's a fact that a small number--a handful--of Lyme
researchers have individually received many millions of
federal research dollars, many of whom shared the same set of
biases and perspectives. Common biases and perspectives are
not objectionable if they are based upon the best scientific
evidence; open dialogue, information sharing, and
transparency can help safeguard the process and the
taxpayers' money.
Patients want research which will restore their health.
Their voice and the voice of the clinicians must be given the
necessary weight to legitimize the research agenda and the
research process. Truth in science can be achieved through
open discussion with diverse viewpoints in an independent
process free from bias and conflicts of interest. The
scientific process fails when one side of a debate controls
the arena and sets the rules to ensure that its viewpoint
prevails.
Patricia V. Smith Lyme Disease Association
