Lyme Disease Vaccines: A Cautionary Tale 257 that would result in arthritis and other complications resembling the late complications of Lyme disease (discussed in greater detail later). On the efficacy side, there was great interest in whether the vaccine might prevent the intermediate and long-term neurological, rheumatological, and other effects of the disease. But since the trials led to the prompt diagnosis and treatment of cases in both the experimental and control groups, such effects were rarely seen. During the 1998 VRBAC meeting, Dr. Thomas Fleming pressed Allen Steere, the discoverer of LD and the chief investigator of the LYMErix trial, and others for evidence that the vaccine prevented these feared chronic manifestations. Steere told the committee that there were virtually no chronic or systemic problems, only one case of trigeminal neuropathy and one with Lyme arthritis. Since these sequelae also were rare in the placebo group, a reasonable interpretation of the very low rate of chronic or systemic problems was that the trial led to the prompt diagnosis and treatment of LD cases and that such treatment was very effective at warding off later problems. When the VRBPAC met again in 2001 to review the safety and efficacy of LYMErix after more than two years on the market, SKB officials continued to argue that the vaccine was safe.2 There was no evidence of a pattern of serious side effects reported from either the usual adverse event reporting or the HMO surveillance program. Despite some evidence of a link between the vaccine and musculoskeletal problems, there was no evidence of autoimmune reactions or treatment-resistant Lyme arthritis. “In all those studies the nature and the frequency of the adverse events were similar to the pre-licensure clinical trial experience,” concluded SKB researcher Dr. Kahn (VRBPAC 2001). But many Lyme disease activists and others at the advisory board meeting already had turned against the vaccine in a major way and were not buying SKB’s assurances about its safety. Vaccine recipients at the meeting claimed that their health had been severely and negatively impacted by the vaccine. “I’m not as knowledgeable as this distinguished panel of experts that I speak to today,” asserted one lay witness. “But I know one thing with all of my being. It was LYMErix which somehow had this devastating effect on my seventeen-year-old child” (Scharf Lurie, VRBPAC 2001). Some advisory panel members were puzzled by the disconnect be- tween the reassuring adverse event reporting and the surveillance data presented by the SKB officials and the passionate narratives of physical