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Estimated reading time: 2 minutes. Contains 443 words.
107-116 Signed by President Bush 1/10/02 Departments
of Labor, Health, and Human Services, and Education, and Related
Agencies Appropriations Act 2002
Appropriations Report Language - S.1536,
Disease Control and Prevention
The Committee is deeply concerned
about the safety of
the Lyme disease vaccine (LymeRix). Over 1,000 adverse event reports
filed with the Food and Drug Administration from December 1998 to
2000. The Committee encourages CDC to work closely with the FDA to
that all adverse event reports are thoroughly and expeditiously
to ensure public safety as the vaccine is being distributed.
should pay particular attention to patients' reports of arthritis when
evaluating these reports.
recognizes that the
current state of laboratory
testing for Lyme disease is very poor. The
situation has led many
people to be misdiagnosed and delayed
treatment. The vaccine clinical trial has documented that more that one
third (36 percent) of the people with Lyme disease did not test
on the most sophisticated tests available. The ramifications of this
in terms of unnecessary pain, suffering and cost is staggering. The
directs CDC to work closely with the Food and Drug Administration to
an unequivocal test for Lyme disease.
Committee is distressed in hearing of the
widespread misuse of the
current Lyme disease surveillance case definition. While the CDC does
that 'this surveillance case definition was developed for national
of Lyme disease: it is NOT appropriate for clinical diagnosis,' the
is reportedly misused as a standard of care for healthcare
product (test) development, medical licensing hearings, and other legal
cases. The CDC is encouraged to aggressively pursue and correct the
of this definition. This includes issuing an alert to the public and
as well as actively issuing letters to places misusing this definition.
recommends that the CDC strongly
support the re-examination
and broadening of the Lyme disease surveillance case definition by the
Council of State and Territorial Epidemiologists. Voluntary and patient
groups should have input into this process. Currently there is just one
definition ('confirmed case') of seven possible categories. By
other categories while leaving the current category intact, the true
of cases being diagnosed and treated will be more accurately counted,
to improved public health planning for finding solutions to the
encouraged to include a broad range of scientific viewpoints
in the process of planning and executing their efforts. This means
community-based clinicians with extensive experience in treating these
patients, voluntary agencies who have advocacy in their mission, and
advocates in planning committees, meetings, and outreach efforts.