Oversight Hearing Lyme Disease: A Diagnostic and Treatment
Dilemma Senate Committee on Labor and
Human Resources August 5, 1993 430 Dirksen, 10:00 AM to 12:00 PM
Joseph J.
Burrascano, Jr., M.D.
There is a core group of
university-based Lyme disease
researchers and physicians whose
opinions carry a great deal of weight.
Unfortunately many of them act
unscientifically and unethically. They
adhere to outdated, self-serving views
and attempt to personally discredit
those whose opinions differ from their
own. They exert strong ethically
questionable influence on medical
journals, which enables them to
publish and promote articles that are
badly flawed. They work with
government agencies to bias the agenda
of consensus meetings, and have worked
to exclude from these meetings and
scientific seminars those with
alternate opinions. They behave this
way for reasons of personal or
professional gain, and are involved in
obvious conflicts of interest.
This group promotes the idea that Lyme
is a simple, rare illness that is easy
to avoid, difficult to acquire, simple
to diagnose, and easily treated and
cured with 30 days or less of
antibiotics.
The truth is that Lyme is the fastest
growing infectious illness in this
country after AIDS, with a cost to
society measured in the billions of
dollars. It can be acquired by anyone
who goes outdoors, very often goes
undiagnosed for months, years, or
forever in some patients, and can
render a patient chronically ill and
even totally disabled despite what
this core group refers to as
"adequate" therapy. There have been
deaths from Lyme disease.
They feel that when the patient fails
to respond to their treatment regimens
it is because the patient developed
what they named "the post Lyme
syndrome". They claim that this is not
an infectious problem, but a
rheumatologic or arthritic malady due
to activation of the immune system.
The fact is, this cannot be related to
any consistent abnormality other than
persistent infection. As further
proof, vaccinated animals whose immune
system has been activated by Lyme have
never developed this syndrome. On the
other hand, there is proof that
persistent infection can exist in
these patients because the one month
treatment did not eradicate the
infection.
Indeed, many chronically ill patients,
whom these physicians dismissed, have
gone on to respond positively and even
recover, when additional antibiotics
are given.
It is interesting that these
individuals who promote this so called
"post-Lyme syndrome" as a form of
arthritis, depend on funding from
arthritis groups and agencies to earn
their livelihood. Some of them are
known to have received large
consulting fees from insurance
companies to advise them to curtail
coverage for any antibiotic therapy
beyond this arbitrary 30 day cutoff,
even if the patient will suffer. This
is despite the fact that additional
therapy may be beneficial, and despite
the fact that such practices never
occur in treating other diseases.
Following the lead of this group of
physicians, a few state health
departments have even begun to
investigate, in a very threatening
way, physicians who have more liberal
views on Lyme disease diagnosis and
treatment than they do. Indeed, I must
confess that I feel that I am taking a
large personal risk here today by
publicly stating these views, for fear
that I may suffer some negative
repercussions, despite the fact that
many hundreds of physicians and many
thousands of patients all over the
world agree with what I am saying
here. Because of this bias by this
inner circle, Lyme disease is both
underdiagnosed and undertreated, to
the great detriment to many of our
citizens. Let me address these points
in more detail.
UNDERDIAGNOSIS
1. Under reporting: The
current reporting criteria for Lyme
are inadequate and miss an estimated
30 to 50% of patients. Some states
curtailed their active surveillance
programs and saw an artificial drop in
reported cases of nearly 40%, leading
the uninformed to believe incorrectly
that the number of new cases of Lyme
is on the decline. The reporting
procedure is often so cumbersome, many
physicians never bother to report
cases. Some physicians have found
themselves the target of state health
department investigators. Finally, to
many physicians and government agents
rely on the notoriously unreliable
serologic blood test to confirm the
diagnosis.
2. Poor Lyme disease diagnostic
testing: It is very well-known that
the serologic blood test for Lyme is
insensitive, inaccurate, not
standardized, and misses up to 40
percent of cases, yet many physicians,
including many of those referred to
above, and the senior staff at CDC and
NIH, insist that if the blood test is
negative, then the patient could not
possibly have Lyme. This view is not
supported by the facts. Lyme is
diagnosed clinically, and can exist
even when the blood test is negative.
The Rocky Mountain Lab of the NIH,
which is the country's best government
laboratory for Lyme research had
developed an excellent diagnostic test
for this illness nearly 4 years ago,
yet further work on it has been
stalled due to lack of funding.
Incredibly, if not for private
donations of just $5,000 from the
non-profit National Lyme Disease
Foundation headquartered in
Connecticut, then this reaseach would
have had to be abandoned. An
additional $30,000 was donated by this
organization to allow them to continue
other valuable projects relating to
vaccine development and disease
pathogenesis. Yet, many physicians
believe that thousands of dollars of
grant moneys awarded by the government
to other, outside researchers is
poorly directed, supporting work of
low relevance and low priority to
those sick with Lyme. In spite of
this, their funding continues, and the
Rocky Mountain Lab is still
underfunded.
3. The university and Government based
Lyme establishment deny the existence
of atypical presentations of Lyme and
patients in this category are not
being diagnosed or treated, and have
no place to go for proper care. RESULTS: Some Lyme patients have had
to see, as many as 42 different
physicians often over several years,
and at tremendous cost, before being
properly diagnosed. Unfortunately, the
disease was left to progress during
that time, and patients were left
forever ill, for by that time, their
illness was not able to be cured. Even
more disturbing, these hard line
physicians have tried to dismiss these
patients as having "Lyme Hysteria" and
tried to claim they all were suffering
from psychiatric problems!
UNDERTREATMENT
1. Because the diagnosis is
not being made, for reasons partly
outlined above.
2. University based and government
endorsed treatment protocols are
empiric, insufficient, refer to
studies involving inadequate animal
models, and are ignorant of basic
pharmacology. They are not based on
honest systematic studies or on the
results of newer information.
3. After short courses of treatment,
patients with advanced disease rarely
return to normal, yet many can be
proven to still be infected and can
often respond to further antibiotic
therapy. Unfortunately, Lyme patients
are being denied such therapy for
political reasons and/or because
insurance companies refuse to pay for
longer treatment, upon the arbitrary
and uninformed advice of these
physicians, who are on the insurance
company's payroll.
4. Long term studies on patients who
were untreated or undertreated
demonstrated the occurrence of severe
illness more than a decade later,
reminiscent of the findings of the
notorious Tuskeege Study, in which
intentionally untreated syphilis
patients were allowed to suffer
permanent and in some cases fatal
sequelae.
5. The Lyme bacterium spreads to areas
of the body that render this organism
resistant to being killed by the
immune system and by antibiotics, such
as in the eye, deep within tendons,
and within cells. The Lyme bacterium
also has a very complex life cycle
that renders it resistant to simple
treatment strategies. Therefore, to be
effective, antibiotics must be given
in generous doses over several months,
until signs of active infection have
cleared. Because relapses have
appeared long after seemingly adequate
therapy, long term followup, measured
in years or decades, is required
before any treatment regimen is deemed
adequate or curative.
6. When administered by skilled
clinicians, the safety of long term
antibiotic therapy has been firmly
established. The very existence of hundreds of Lyme
support groups in this country, and
the tens of thousands of dissatisfied,
mistreated and ill patients whom these
groups represent, underscores the many
problems that exist out in the real
world of Lyme disease. I ask and plead
with you to hear their voices, listen
to their stories, and work in an
honest and unbiased way to help and
protect the many Americans whose
health is at risk from what now has
become a political disease.
Thank you. -
Joseph J. Burrascano, Jr.,
M.D. -- 139 Springs Fireplace Road East Hampton, NY 11937