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Vaccine Maker Pulls Drug Off Market

Feb 26, 2002 | AP With tick season approaching, the maker of the nation's only vaccine against Lyme disease pulled it off the market, citing poor sales.

Lymerix had caused controversy in recent years, as patients said they were sickened by the vaccine and asked the government to restrict sales. Some filed lawsuits against maker GlaxoSmithKline.

Federal health officials said Tuesday they had found no evidence that the vaccine was dangerous. They urged people in Lyme-plagued states to take precautions against the pin-sized ticks that spread the disease.

Lymerix had $40 million in sales its first year on the market, and hundreds of thousands were vaccinated. But GlaxoSmithKline projected that fewer than 10,000 people would seek vaccination this year, and ended sales because "there's just no demand for it," said company spokeswoman Ramona Dubose.

Lyme disease is spread by ticks that live in wooded and grassy areas nationwide, but especially in the Northeast, from Maryland to Maine, and in Wisconsin and Minnesota. It causes fatigue, fevers and joint pain that can persist for weeks. Some patients develop severe arthritis. If not treated with antibiotics, Lyme disease can severely damage the heart and nervous systems.

The FDA (news - web sites) approved the sale of Lymerix in 1998. But the Centers for Disease Control and Prevention (news - web sites) had urged that only people at high risk of Lyme disease be vaccinated, largely because the expensive vaccine didn't offer complete protection. Studies showed it was 80 percent effective after people got all three required shots.

After vaccinations began, some patients reported arthritis, muscle pain and other troubling symptoms.

Many of the symptoms were similar to Lyme disease itself, and 15 percent of the U.S. population has arthritis anyway. Scientists found teasing out any connection to Lymerix difficult.

In one study, 5,000 people got Lymerix and another 5,000 got dummy shots. Two percent of each group developed arthritis-like symptoms.

The CDC re-examined 905 possible side effects reported to the government between 1998 and July 2000. The CDC's results, just published in the journal Vaccine, found no signs that Lymerix caused arthritis, but did find 22 cases of allergic reaction.

Those studies don't persuade some critics. At least seven lawsuits are pending over alleged Lymerix reactions, and several hundred more people may file, said Philadelphia attorney Stephen A. Sheller.

"We're thrilled" that Lymerix is being taken off the market, said Karen Forschner of the Lyme Disease Foundation, who recently presented information to the FDA that she says suggests Lymerix safety studies were seriously flawed.

The FDA is continuing to investigate.

While Lyme cases have reached record highs in recent years, there's no way to know if this spring will bring a bumper crop of Lyme-bearing ticks, said CDC Lyme expert David Dennis. But there are steps people should take to lower their risk of Lyme and other tick-borne diseases, he advised:

_Check yourself and your children daily for ticks. Scientists believe Lyme-bearing ticks must remain attached for 36 hours to infect someone.

_Wear long sleeves and pants tucked into socks or boots when venturing into tick-prone areas like unmowed grass or brush, and use insect repellent that contains DEET.

_To discourage ticks from moving into yards, put a barrier, such as a layer of wood chips, between woods and grass. Remove leaves and brush; ticks prefer dark, moist habitats.

Lyme disease is spread by ticks that feed on deer and rodents. Because communities have been leery of wide-scale pesticide use, the CDC is testing more targeted technology: bait boxes that rub tick-killing pesticides on rodents, and feeding bins that do the same to deer.

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