256 Robert A. Aronowitz to the pharmaceutical industry, believed that there were record-keeping problems in the Connaught trial that would have made regulatory ap- proval difficult. Although not privy to Connaught’s decision-making process or drivers, Loren Cooper (personal communication, August 11, 2011), an SKB lawyer, offered that it was not uncommon for one vaccine company to look at the experience of others when making development decisions. In this instance, Connaught may have anticipated that the controversy surrounding LYMErix would also impact its vaccine and presciently decided to “stop the bleeding” rather than pursue a vaccine unlikely to be commercially successful. One early warning sign of these problems was the report that volun- teers in the clinical trials were suing vaccine manufacturers for the harm they experienced (Rierden 1996). Many of the problems with low demand were predictable far in ad- vance of the pharmaceutical companies’ decisions to withdraw their products. In most parts of the United States, the disease is rare; it can be successfully treated by antibiotics and is not deadly. Most experts believe that complications like arthritis, Bell’s palsy (temporary yet scary facial nerve paralysis), heart block, and back pain are infrequent, respond to treatment, and, even if untreated, eventually resolve. Infection can be prevented by individual measures such as tick checks and protective clothing. To the degree that these measures are a burden, a vaccine could never totally supplant them anyway because ticks carry other infectious diseases besides LD and vaccine efficacy is never 100 percent. Because there is no person-to-person LD transmission, even the most effective vaccine would offer no protection to the unvaccinated (i.e., no herd immunity). So it remains puzzling why Connaught invested so much in vaccine development and its successful phase III clinical trial only to withdraw the vaccine before FDA approval or, similarly, why SKB anticipated a much larger market. I return to this puzzle later. At the time of the FDA’s licensing of LYMErix, there were only limited data on the vaccine’s long-term safety and the duration of im- munity. Since the rationale for a vaccine against a “mild” and easily treated disease affecting small populations in specific regions remained marginal, regulators and others had an understandably cautious, wait- and-see attitude toward the vaccine’s safety, mandating SKB to conduct postmarketing surveillance (SKB agreed to set up a novel, HMO-based surveillance system). At the time of licensing, regulators and others were quite concerned that the vaccine might induce an autoimmune reaction