Nov. 27, 2000 (Washington) -- Lyme disease generally does not fit the description of a condition that would make national headlines. After all, the disease is not life threatening, it has been around for more than 100 years, and it can be treated using antibiotics. But the disease has now become instilled in the limelight thanks in large part to an ongoing controversy regarding how the disease should be treated and prevented.
Lyme disease is an infection caused by a microscopic bacterial organism. These microscopic bacteria reside in wild animals but can be transferred to humans and pets through deer ticks. Early symptoms include a rash, headache, fever, fatigue, stiff neck, and muscle aches.
The disease made national headlines in early November when some Lyme experts accused medical boards of improperly targeting doctors in the Northeast -- where most cases are reported -- for disciplinary action. The accusations were based on several investigations and disciplinary actions taken against doctors in that region, who prescribed to their patients a longer course of antibiotics than the generally accepted guidelines.
That dispute will soon be resolved by a NIH study. But the debate itself has now expanded to include a relatively new vaccine called Lymerix, which some doctors believe may be sparking the early onset of rheumatoid arthritis.
"There are so many cases that it is too much to be coincidental," says Andrea Gaito, MD, a rheumatologist in New Jersey, who sees about 20 to 30 cases of Lyme disease each week.
Gaito and some of her colleagues believe that the vaccine may trigger a gene that causes arthritis. In effect, she says, this means people with this gene may suffer from that condition much earlier in life than expected if they receive the Lyme vaccine. As a result, Goti, who also serves as president of the International Lyme and Associated Diseases Society, would like to see doctors stop giving the vaccine in favor of just treating the disease when it occurs.
"I feel the best way to prevent Lyme disease is public education, tick prevention, and the use of tick repellents," she tells WebMD.
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.