Lyme Disease in the Limelight
But although some physicians share Gaito's concerns, there is at present little evidence, if any, for regulatory authorities to act upon.
The FDA recently released a summary of the adverse events associated with the vaccine, in which there were 42 reported cases of arthritis and seven reported cases of rheumatoid arthritis. But in releasing the document, the agency concluded that the numbers were not unexpectedly high considering the number of people with arthritis in the general population.
"The experience is consistent with what was seen in the clinical trials," adds Brian Jones, a spokesman for SmithKline Beecham, the maker of Lymerix. "Lymerix is the only available protection, and it continues to be licensed by the FDA as an effective and safe means of prevention," he adds.
Still, the suspicion may be enough for at least some patients. Although Lyme disease can be debilitating in its later stages, the early symptoms are reversible. And there is also the cost: For the vaccine to be about 80% effective, three shots are needed over the course of a year at about $50 per shot.
Figures are not available for how many people have had the vaccine. But those factors alone have even led some of the vaccine's developers to question its value. While the vaccine may be of some value in areas like the Northeast, it is really a personal decision whether to use this type of prevention elsewhere, they have noted in past interviews.
As for whether to have the vaccine, these experts also caution that Lyme disease can cause arthritis, heart irregularities, paralyzed facial muscles, and other disabilities in its later stages. These disabilities, they add, will most certainly occur if the disease goes undiagnosed or misdiagnosed as is often the case due to its wide range of symptoms.
Almost 12,000 cases of Lyme disease have been reported so far this year, bringing the national total to a little over 150,000 cases since 1980.