Why Was the Lyme Disease Vaccine Tossed Away?

It was pulled from the market almost immediately after it was developed in 1998. Twenty-five years later, the painful disease is on the rise

In the mid-1970s, physicians were puzzled after a cluster of children and adults in the town of Lyme, Connecticut, all developed mysterious, arthritis-like symptoms. They complained of recurrent bouts of pain and swelling in their joints; some developed fevers and rashes, others had unusual skin lesions. While doctors initially suspected that a virus might be the cause of the ailments, when a group of Yale scientists started to look closer, they discovered that the symptoms were caused by a bacteria transmitted by tick bites. The illness is now known as Lyme disease.

At first, most people didn’t see the disease as cause for widespread concern. After all, it only affected a few people, most of whom were presumed to be affluent Americans: the types who vacationed in Martha’s Vineyard or rode horses in the woods during their free time. But one scientist, named Sam Telford, was watching closely. The son of a World Health Organization parasitologist, Telford had grown up learning about all sorts of diseases that animals can spread and wanted to focus his career on preventing them. His colleagues at Harvard questioned why he was dedicating so much time to a medical problem that seemed insignificant, but as he continued his research, cases of Lyme began to rise, appearing in the grassy areas of Nantucket and around other parts of New England.

Telford’s persistence paid off. His research caught the attention of drug maker SmithKline Beecham, now GlaxoSmithKline, which asked him to work on a Lyme vaccine in response to the growing number of cases. In 1998, the US Food and Drug Administration approved the first-ever vaccine for Lyme disease, and within a year, as the disease spread to other regions of the US and into Canada, 1.5 million doses of LYMErix had been sold.

To Telford and others in the science community, the vaccine was a huge success. But the impact was short lived. Just one year after it hit the market, lawsuits started pouring in from patients who claimed the shot caused them harm. There was the New Jersey nurse who, after getting her second LYMErix vaccine in the late ’90s, complained of unbearable pain that escalated to a point where, she said, she could barely move when she woke in the morning; the mother who claimed that her daughter developed arthritis and lost peripheral vision in her left eye after the jab. In 2001, she told the Washington Post that getting her the shot was the “biggest mistake” of her life. One Philadelphia lawyer, who represented more than 350 plaintiffs, told the Guardian back in 2002, “We have people who got shots of this thing, and within days, they were in wheelchairs for the rest of their lives.” Even doctors at the time offered caution: in one New York Times article, an infectious-disease doctor and Lyme specialist said she’d recommend holding off on getting the vaccine for another year, until more questions were answered.

While the FDA found no evidence that the vaccine caused the adverse events that the claimants alleged—in fact, it was shown to be safe and about 75 percent effective in reducing the risk of infection during clinical trials—the damage was done. LYMErix’s public image was tarnished, and in 2002, after declining sales and waning public interest, GlaxoSmithKline pulled the vaccine off the shelves for good.

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Why Was the Lyme Disease Vaccine Tossed Away?

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