To the Editor:
I strongly disagree with the suggestion that the FDA should consider reintroducing the Lyme vaccine LYMErix, which appeared in the Times’s August 28 Op-Ed by Duncan Caldwell. To propose that the LYMErix vaccine be returned to the market is irresponsible given its poor performance and history of adverse events.
LYMErix was approved by the FDA in December 1998. The vaccine was marketed with a frank acknowledgement of its limited efficacy. This vaccine required users to submit to three separate vaccinations within a one-year period and even then it was only 76 percent effective. Data further suggested that yearly booster shots would be necessary. Members of the National Vaccine Advisory Committee (NVAC), in certifying LYMErix, warned that the vaccine should not be given to people who suffer from certain commonly encountered neurologic, cardiac, and arthritic conditions. Moreover, LYMErix was never approved for use in children under 15 years of age, the population perhaps most at risk for developing Lyme. In an unguarded moment, Dr. Patricia L. Ferrieri, the NVAC chairwoman and a professor at the University of Minnesota Medical School, admitted that it was “rare that a vaccine is voted on with such ambivalence and such a stack of provisos….”
In light of this, it should not be surprising that LYMErix proved to be an unpopular vaccine. LYMErix was expensive. Consumer resistance mounted as anecdotal reports of adverse events proliferated. Post marketing surveillance studies revealed that vaccination with LYMErix actually increased one’s risk for developing chronic treatment-resistant arthritis among a specific population genotype. People got sick and sued. Epidemiological constructs used to conduct the clinical trials were examined and deemed by some to be suspect. A class-action lawsuit was commenced and exposed long standing financial ties between the vaccine’s manufacturer and some of the principal investigators.
Market forces worked as they should. Consumers determined that LYMErix did not pass the risk-benefit test and shunned the product. In response to these developments, SmithKline Beecham voluntarily removed LYMErix from the marketplace in February 2001.
Given the proliferation of ticks on the Vineyard, an effective Lyme vaccine would be a welcome addition. The history of LYMErix, however, should serve as a cautionary tale to future developers of any Lyme vaccine — primum non nocere: first, do no harm. Absent a reliable diagnostic test and an enhanced understanding as to the biochemical processes by which Lyme disease makes certain people chronically ill, we should not rush to approve another flawed vaccine just to have a vaccine.
Claire F. Rush