Lyme
Disease: Two Standards of Care
By
Lorraine Johnson, JD, MBA Executive Director, CALDA
(California
Lyme Disease Association)
Updated
February, 2005
The central
difficulties in the diagnosis and treatment of Lyme disease
stem from the lack of sufficiently sensitive and reliable biological
markers of the disease. Without such markers, it is difficult
to determine who has the disease, the effectiveness of a course
of treatment, and the end point of treatment. The ideal antibiotics,
route of administration, and duration of treatment for persistent
Lyme disease are not established. No single antibiotic or combination
of antibiotics appears to be capable of completely eradicating
the infection, and treatment failures or relapses are reported
with all current regimens, although they are less common with
early aggressive treatment.[1–3]
Opinion
within the medical community is deeply divided regarding the
best approach for treating Lyme disease, particularly persistent
Lyme disease that is not cured by short-term protocols. This
split has resulted in two standards of care. Both viewpoints
are reflected in peer-reviewed, evidence-based guidelines. Some
physicians treat patients for 30 days only and assume that remaining
symptoms reflect a self-perpetuating autoimmune response.[4]
Other physicians assume that the persistent symptoms reflect
on-going infection and gauge the duration of treatment by the
patient's individual clinical response. These physicians believe
that there is insufficient evidence at this point to adopt standardized
treatment protocols.[5]
While each
viewpoint has a strong underlying hypothesis, the scientific
evidence supporting either viewpoint is equivocal. Outcomes
research is limited and conflicting. The NIAID has only funded
three double-blind, placebo-controlled treatment outcome studies
for long-term treatment of persistent Lyme disease. The findings
of two studies (Klempner and Krupp) are contradictory, with
one indicating that continued treatment is beneficial for treating
fatigue and the other indicating that it is not.[6–8]
The third NIAID-funded study has recently been completed and
preliminary results support continued antibiotic treatment for
patients with persistent Lyme disease.[9]
The findings of five non-controlled studies support continued
treatment.[1, 10–13]
The existence of limited or conflicting controlled studies is
not uncommon in the practice of medicine. Where this is the
case, the unique clinical course of the patient, of necessity,
bears the laboring oar in treatment decisions.
Insurance
companies have placed the full weight of their economic clout
behind the less expensive short-term treatment protocols. More
expensive longer-term treatment options are discredited as "experimental"
or "not evidence-based." The point, of course, is that the science
underlying both the short-term and the longer-term treatment
options is equally uncertain (like prostate cancer). The appropriate
response to equivocal research findings in healthcare outcomes
is to fund more research. It is estimated that only 20% of medicine
practiced today is rooted in double-blind studies.[14]
The bulk of medicine today is practiced in the grey zone. Evidence-based
medicine requires only that medicine be practiced in accordance
with the evidence that currently exists, not that treatment
be withheld pending research.
Insurance
companies have adopted guidelines reflecting short-term treatment
approaches. However, the legal standard of care for treating
a condition is determined by the consensus of physicians who
actually treat patients, not by treatment guidelines.[15]
Moreover, more than one standard of care may exist. A number
of surveys have found a fairly even split among treating physicians.
One survey found that 57% of responding physicians treat persistent
Lyme disease for three months or more.[16] Fallon notes that
for over 3400 patients screened for the Columbia University
study of persistent Lyme disease, the mean duration of IV treatment
was 2.3 months and the mean duration of oral antibiotic therapy
was 7.5 months.[6] In another
survey, “50% of the responders considered using antibiotics
for a time greater than one year in a symptomatic seropositive
Lyme disease patient. Almost that same number would extend therapy
to 18 months if needed.”[17]
For treating early Lyme disease, there are conflicting surveys.
Most physicians responding to one survey specified short-term
treatment[18], while 43%
of those responding to another survey would treat erythema migrans-positive
Lyme disease for three months or more.[16]
All jurisdictions that have considered the matter have found
two standards of care in the treatment of Lyme disease.[19]
When more
than one standard of care exists, the critical question becomes
who decides the appropriate course of treatment for the patient.
Under the medical ethical principle of autonomy, the treatment
decision belongs to the patient. Hence, the American Medical
Association requires that the physician disclose and discuss
with the patient not only the risks and benefits of the proposed
treatment, but also the risinsks and benefits of available alternative
treatments (regardless of their cost or the extent to which
the treatment options are covered by health insurance).[20]
For example, patients with prostate cancer (where significant
uncertainty exists regarding long-term treatment outcomes) must
elect between watchful waiting, radiation and surgery. The legal
doctrine of informed consent also requires that patients be
advised of material treatment options. Treatment choices involve
trade-offs between the risks and benefits of treatment options
that only patients-who know the kinds of risks they are willing
to run and the types of quality of life outcomes that matter
to them-are uniquely suited to make.
Sound health
care policy follows suit, with healthcare costs generally witnessing
a reduction when the patient's preference is supported. Patient
preference exists whenever there is more than one acceptable
treatment approach. When inefficiencies in the Medicare system
were analyzed by looking at small area variations in medical
practice, most variation in preference-sensitive care was found
to reflect physician opinion. In patient preference situations,
patient and provider values are often in conflict and public
healthcare researchers recommend reducing the medical practice
variations in these situations by “reduc[ing] scientific
uncertainty through outcomes research... and establish[ing]
shared decision-making for preference-based treatments.”[21]
Respect
for the basic autonomy of the patient is a fundamental principle
of medical ethics. Without adequate information about treatment
options, their probable outcomes, and the risks and benefits
associated with each, patients cannot act autonomously. Today,
however, many patients are either denied treatment by their
HMO physicians who follow actuarial treatment protocols generated
to keep treatment costs down, or they must find an independent
physician to treat them, with the all but forgone conclusion
that coverage for this treatment will be denied by their insurer
based on cherry-picked (economically favorable) guidelines.
Moreover, HMO physicians generally do not advise their patients
that treatment alternatives exist.
Scientific
uncertainty about Lyme disease has resulted in more than one
treatment approach (like prostate cancer). We agree with the
AMA, ACP and other professional medical organizations interested
in promoting informed patient consent and want to make sure
that:
- Physicians,
insurers, patients and governmental agencies are educated
that two treatment approaches exist;
- Physicians
give patients sufficient information about treatment options
to enable patients to make a meaningfully informed choice
and respect the autonomy of that choice;
- Insurance
reimbursement be provided for treatment rendered in accordance
with either standard of care; and
- Government
agencies provide unbiased information and remain neutral regarding
both standards of care and treatment approaches.
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