Tick Talk Time

Spring is here. Flowers are blooming. Grass is growing. And disease-carrying ticks are beginning to stir after a brief, mild winter. Time to start thinking about how to recognize and prevent Lyme disease, that backyard nuisance spread by the bite of the impossibly small deer tick. So far this year, Maryland has reported 97 cases to the Centers for Disease Control and Prevention (CDC). Last year there were 1,211 cases in Maryland, and a total of 21,304 cases throughout the U.S. Lyme disease is a multistage, inflammatory infection caused by the bacterium Borrelia burgdorferi. Most of the time the infection presents as a “bull’s-eye” skin rash with various arthritic, neurologic or cardiac symptoms. Fortunately, these infections respond well to antibiotics when caught early. In 2000, the Infectious Disease Society of America (IDSA) published clinical guidelines to aid physicians in recognizing and treating Lyme disease. After six more years of clinical experience and research, those guidelines have been updated. The new guidelines will be published in the journal, Clinical Infectious Diseases, and will be available on the IDSA web site (www.idsociety.org). In addition, the CDC recently published physician guidance for diagnosing and treating other tick-borne infections, including Rocky Mountain spotted fever, ehrlichiosis, and anaplasmosis. Lyme disease remains the most common insect-borne infection in the U.S. Ninety-five percent of cases come from Maryland and eleven other states. In order to get an idea of the cost of preventing and treating Lyme infections, researchers from the CDC and the University of

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Maryland studied five Lyme endemic counties on the Eastern Shore during 1997-2000. Looking at all dollar costs and all types of cases, they found the median—or typical—cost of Lyme disease per person was $281.00. They also found the average cost per case decreased over the course of the study period. That may mean more people are taking better precautions against ticks and visiting their doctors more frequently. Physicians also may be ordering more blood tests and providing faster antibiotic treatments. The study was limited in scope, and the researchers noted that “more research on the social behavior of…patients and economic evaluation of…prevention interventions is needed.” Perhaps they could start by looking at the demise and possible rebirth of the Lyme disease vaccine. In the 1990’s Lyme disease activists were pushing federal agencies and researchers for a vaccine. In 1997, activists persuaded a number of U.S. Senators (including Barbara Mikulski) to write to the Food and Drug Administration urging a speedy review of new Lyme vaccine applications. One of the vaccines, Lymerix, was approved for general use in December 1998. By February 2002, it was off the market. Sales were poor. Large numbers of people were unwilling to pay $100 for a vaccine that required three shots and an annual booster to protect them from a non-fatal, non-communicable infection that was confined to a handful of states. In the interval between vaccine approval and withdrawal, some vaccine recipients and activists complained that the vaccine induced an autoimmune arthritis. The FDA and CDC investigated 905 adverse reaction reports but found no correlation between Lymerix and arthritis. Still, the absence of harm or causality never got in the way of expensive litigation. A lawsuit was filed in Philadelphia and the vaccine maker eventually settled with $1,064,247 in fees and

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costs to the lawyers. (As far as I know, no patient received any money from the settlement.) So ended the ten-year quest for a Lyme vaccine in the U.S. Surprisingly, the Lyme vaccine has been resurrected in Europe. Baxter Vaccines in Vienna, Austria has developed a second-generation vaccine based on the work of American scientists at Brookhaven Labs on Long Island. The new vaccine has been designed to protect against the three species of Borrelia bacteria that cause Lyme disease in Europe. (There’s only one in the U.S.) In addition, part of the vaccine’s structure allegedly associated with autoimmune arthritis complaints has been removed—making this the first vaccine specifically designed to protect against both an infection and litigation. Based on preliminary trials, the new Lyme vaccine appears to be safe and effective. Perhaps this new vaccine will find a more favorable market in Europe. Europeans tend to have more serious, neurologic forms of Lyme disease so they may be more inclined to pay for a vaccine. They also tend to be less litigious, and many Europeans have prior experience with another vaccine against a dangerous viral infection called tick-borne encephalitis. In the absence of a U.S. vaccine for Lyme disease, we’ll just have to continue relying on personal preventive measures, experienced physicians, and luck. Readers can find out more about preventive measures from the CDC (www.cdc.gov) and the American Lyme Disease Foundation (www.lyme.com).

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