Lyme Disease Vaccines: A Cautionary Tale A Personalized Product? 267 At the postmarketing regulatory hearings (VRBPAC 2001), Dr. Richard Platt referred to LYMErix as a “personal choice vaccine.” At these same hearings, consumer activist Dr. Sidney Wolfe recalled an earlier IOM report that placed this whole idea in what they call their less favorable category, the lowest ranking in priorities of vaccine development, just because of the fact that (a) the vaccine is not extraordinarily effective; (b) it is not preventing a life-threatening disease; and (c) for most people, a successful antibacterial intervention can occur not when you have a tick but when you have some clinical symptoms that are suggestive of actually beginning to have Lyme disease. Not everyone agreed that these characteristics of the vaccine and LD meant that the vaccine was optional and should receive less support or tighter regulation than most other vaccines. At the initial ACIP review in 1998, committee member Stanley Plotkin argued that a safe and effective vaccine with a limited market should nevertheless get a strong recommendation from policymakers. The issue of whether to actually use a highly recommended vaccine should remain with the individual. The LD vaccine, Plotkin argued, was the first of many. . . . One is going to have to permit the individual to make some choices about whether a reduction from two in one thousand to one in one thousand is significant for that person. So I would urge the committee to distinguish in this type of vaccine between public health issues and individual issues. (ACIP 1998) In this new world of personal choice, vaccine manufacturers were motivated to persuade potential consumers. In the case of LD vaccines, consumers could be sold freedom from LD fears and the moral satisfaction following proper self-care for themselves and their family. So to succeed in the marketplace, vaccine makers would need to raise awareness of the risk of LD and also of the benefits of the vaccine. After the FDA approved LYMErix, SKB launched one of the very first large direct-to-consumer advertising (DTCA) campaigns. “I never thought I was a target for Lyme disease . . . until I found out you can get it