Lyme Disease - Excerpts from Public Law 107-116 Signed by President Bush 1/10/02

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Excerpts from Public Law 107-116 Signed by President Bush 1/10/02 Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act 2002

Senate Appropriations Report Language - S.1536, SR.107-84.

Centers for Disease Control and Prevention

Lyme Disease - The Committee is deeply concerned about the safety of the Lyme disease vaccine (LymeRix). Over 1,000 adverse event reports were filed with the Food and Drug Administration from December 1998 to October 2000. The Committee encourages CDC to work closely with the FDA to ensure that all adverse event reports are thoroughly and expeditiously investigated to ensure public safety as the vaccine is being distributed. Investigators should pay particular attention to patients' reports of arthritis when evaluating these reports.

The Committee 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 proper treatment. The vaccine clinical trial has documented that more that one third (36 percent) of the people with Lyme disease did not test positive on the most sophisticated tests available. The ramifications of this deficit in terms of unnecessary pain, suffering and cost is staggering. The Committee directs CDC to work closely with the Food and Drug Administration to develop an unequivocal test for Lyme disease.

The Committee is distressed in hearing of the widespread misuse of the current Lyme disease surveillance case definition. While the CDC does state that 'this surveillance case definition was developed for national reporting of Lyme disease: it is NOT appropriate for clinical diagnosis,' the definition is reportedly misused as a standard of care for healthcare reimbursement, product (test) development, medical licensing hearings, and other legal cases. The CDC is encouraged to aggressively pursue and correct the misuse of this definition. This includes issuing an alert to the public and physicians, as well as actively issuing letters to places misusing this definition.

The Committee 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 developing other categories while leaving the current category intact, the true number of cases being diagnosed and treated will be more accurately counted, lending to improved public health planning for finding solutions to the infection.

The CDC is encouraged to include a broad range of scientific viewpoints in the process of planning and executing their efforts. This means including community-based clinicians with extensive experience in treating these patients, voluntary agencies who have advocacy in their mission, and patient advocates in planning committees, meetings, and outreach efforts.