Lyme Disease Vaccines: A Cautionary Tale 263 Heterodox critics pointed out that the surveillance systems used to identify vaccine complications were imperfect and rigged to underreport problems. Reports of adverse reactions depend entirely on the willing- ness, energy, and competence of the physicians in practice. Side effects would not be reported if physicians believed they were not related to vac- cine exposure. So recognizing adverse reactions was, in effect, a closed, circular system in which preexisting biases shaped reporting, which in turn reinforced these biases. No wonder there was underreporting of the vaccine’s side effects. “When asked if they had reported this to the ad- ministering doctor and if the doctor had reported the adverse event,” lay advocate Pat Smith observed, “the usual response was that the doctor did not take the complaint seriously or did not think that these symptoms were related” (VRBPAC 2001). SKB had promised to make adverse event reporting more sensitive and objective by establishing a surveillance system based on the electronic medical records of a large managed care system in New England. But the vaccine was used much less often than expected, making surveillance difficult. At the postmarketing regulatory hearings, some LD advocates heavily criticized this program, even though the low uptake that made this surveillance system a failure was partly caused by the activists’ opposition to the vaccine. They argued that postmarketing surveillance had made guinea pigs out of the vaccine users. “We had no idea that there were unresolved safety issues requiring further study,” one advocate observed about the licensed vaccine, “and that by taking this vaccine our family would unwittingly become subjects of an ongoing drug trial” (Lori Gerlbert, testimony, VRBPAC 2001). The Vaccine’s Immune Danger The case against the LD vaccine was different from what had inspired the opposition to other vaccines in recent decades. Higher than expected levels of Guillame-Barre syndrome had ended the 1976 swine flu im- munization program (Neustadt and Fineberg 1978); increased numbers of intussusceptions had led to the recall of an early rotavirus vaccine just around the time LYMErix was first being marketed; and the alleged link between MMR vaccine and autism has been a simmering controversy since the time of the LD vaccine controversy. The main case against the vaccine was that it caused LD-like complications.