http://www.nytimes.com/aponline/health/AP-Lyme-Vaccine.html
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February 26, 2002 Vaccine Maker Pulls Drug Off Market
By THE ASSOCIATED PRESS
Filed at 5:33 p.m. ET WASHINGTON (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 approved the sale of Lymerix in 1998. But the Centers for Disease
Control and Prevention 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. ^------ On the Net: CDC Lyme site: Lyme Disease Foundation: |
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INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR
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AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER. |