Lyme Disease
The Lyme vaccine: a cautionary tale
People living in endemic areas acquire Lyme disease from the bite of an infected tick. This infection, when diagnosed and treated early in its course, usually responds well to antibiotic therapy. A minority of patients develops more serious disease, particularly after a delay in diagnosis or therapy, and sometimes chronic neurological, cardiac, or rheumatological manifestations. In 1998, the FDA approved a new recombinant Lyme vaccine, LYMErix™, which reduced new infections in vaccinated adults by nearly 80%. Just 3 years later, the manufacturer voluntarily withdrew its product from the market amidst media coverage, fears of vaccine side-effects, and declining sales. This paper reviews these events in detail and focuses on the public communication of risks and benefits of the Lyme vaccine and important lessons learned.
CONCLUSIONS.
The complicated history of LYMErix™ provides important lessons. Although the FDA did not revoke the licence, the manufacturer withdrew the product amidst falling sales, extensive media coverage, and ongoing litigation, even though studies indicated the vaccine represented a cost-effective public health intervention for people at high risk of acquiring Lyme disease [23]. Although preliminary evidence supported LYMErix™ safety, product withdrawal precluded completion of more definitive studies. In the wake of the scientifically justified withdrawal of the rotavirus vaccine, LYMErix™ entered the market at a time of extremely low public tolerance for vaccine risk. Nonetheless, in the absence of a Lyme vaccine, the incidence of B. burgdorferi infection continues to be ~20 000 case per year in the United States [3] with thousands of additional cases occurring globally. Physicians effectively treat the majority of these cases with antibiotics, although some cases have complicated courses. Low demand for the vaccine and its subsequent withdrawal from the market represent a loss of a powerful tool for Lyme disease prevention. Although the European vaccine manufacturer Baxter Vaccines has developed a new Lyme vaccine, which they are considering studying in clinical trials, the new vaccine must overcome considerable public aversion for this product to gain widespread global acceptance [38, 39]. As we ask how to weigh public health benefits of interventions against potential risks (notably incurred by identifiable individuals), the LYMErix™ case illustrates that media focus and swings of public opinion can pre-empt the scientific weighing of risks and benefits in determining success or failure.