Why is there so much controversy surrounding Lyme disease? Why does it seem you can’t get an accurate Lyme disease test?
The State of Lyme
The incidence of Lyme disease is approaching half a million cases per year in the United States, according to a 2021 Centers for Disease Control & Prevention (CDC) report based on data from commercial insurance claims. Yet fewer than 40,000 cases are reported to the CDC in any given year, exposing a massive discrepancy between the actual prevalence of the disease and the few cases that meet the CDC’s surveillance reporting definition.
Despite its alarming incidence rate and often catastrophic effects on human health, there has been little advancement in diagnostic and therapeutic technologies for Lyme in the last 40 years. The CDC and Infectious Diseases Society of America (IDSA) continually support only the use of outdated serological techniques that are known to be inadequate, while simultaneously acknowledging that better tests are needed. The reasons for such double-speak and neglect are inextricably intertwined with the sordid history of Lyme disease vaccines.
Lyme vaccine development has continued for the last three decades despite evidence that the causative organism—the spirochetal bacteria Borrelia burgdorferi—evades immunity in multiple ways that may make it impossible for a vaccine to prevent infection. The most recent effort, a candidate known as VLA-15 from Pfizer and French biotech Valneva, is now in phase III trials. Last February it was revealed that due to alleged violations of good clinical practice, Pfizer had shut down all trial sites run by contractor Care Access, eliminating roughly half of the enrolled participants.
Pfizer’s record of “engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results” may alone warrant suspicion about their recent actions. But in the context of a Lyme vaccine, suspicion should be heightened. The last Lyme vaccine on the market, SmithKline Beecham’s LYMErix, was withdrawn in 2002 amid numerous injury claims, federal agency hearings, and class action lawsuits. Which begs the question, is history repeating?
Stepping back three decades
In June 1994, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) devoted a lengthy meeting to the three companies that had Lyme vaccines in development. According to the official meeting transcript, the primary order of business was to answer the question, “Is the CDC case definition for Lyme disease appropriate for a pivotal efficacy trial?”
Why would this even be a question? The standard diagnostics at the time—mainly the ELISA, a serologic assay that measures antibodies produced against the bacteria—were known to produce a large proportion of false negatives. When the CDC discontinued routine testing of samples in its labs in 1988, it stated in a letter to the Oregon Public Health Laboratory that the sensitivity of the ELISA ranged from 13% to 27% in clinically recognized cases. Obviously, this would hamper any trial operator’s ability to assess possible Lyme infection and the vaccine’s overall effectiveness. If you can’t diagnose cases, how can you determine whether your vaccine works?
Hellbound and Down 