- NEW YORK (Reuters)
- GlaxoSmithKline Plc on Tuesday said it was discontinuing sales of the
world's only vaccine to prevent Lyme disease because of poor demand, but
denied it was pulling the plug on the product because of widespread safety
concerns.
-
- "The safety of Lymerix is not a factor in our decision.
The scientific record remains clear that the vaccine is safe and effective,"
Ramona Dubose, a spokeswoman for the firm, said in an interview.
-
- Lymerix was launched in 1999 in the United States and
Canada by SmithKline Beecham, which later merged with rival British drugmaker
Glaxo Wellcome.
-
- Although the vaccine was taken by hundreds of thousands
of people and boasted $40 million in revenues its first year, sales fizzled
after highly publicized accounts by some users that they suffered arthritis-like
symptoms, muscle pain and other ailments after being vaccinated.
-
- "We were expecting only 10,000 people to be vaccinated
this year. The demand for Lymerix is not there," Dubose said. She
stressed that Glaxo was voluntarily discontinuing sales for economic reasons,
but not recalling the vaccine.
-
- "We've told doctors if they opt to return the vaccine
they have on hand, we'll reimburse them," she said.
-
- Hundreds of people who took the vaccine are suing Glaxo
because of alleged side effects, but Glaxo contends the incidence of arthritis
among Lymerix users is no greater than that of the overall population.
-
- The U.S. Centers for Disease Control last month said
it found no unexpected safety problems with Lymerix after the agency reviewed
905 reports of side effects stretching back to late 1998.
-
- The vaccine, which is given in three staggered doses,
is considered 78 percent effective against the bacterium borrelia burgdorferi,
which is spread mainly by deer ticks.
-
- Lyme disease causes a characteristic bulls-eye rash in
many people, as well as initial flu-like symptoms like headache, fever,
fatigue and muscle aches.
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- It is highly treatable with antibiotics if diagnosed
early. But the Lyme bacteria can spread over months and years to other
parts of the body and cause serious late-stage problems affecting the joints,
tendons and nervous system.
-
- The CDC said in January that almost 18,000 new American
cases of Lyme disease were reported in 2000, a record level that was well
above the yearly average of about 13,000 cases reported since 1991.
-
- Most recently reported cases were in the Northeast and
in mid-Atlantic and north-central states, with Connecticut hardest hit
with 111 cases reported for every 100,000 people. The disease was named
after the Connecticut town where it was discovered in the 1970s.
-
- Dubose said Glaxo has no plans to develop another Lyme
disease vaccine. She said the firm had dropped plans to conduct a late-stage
trial of a vaccine against a different strain of the disease found in Europe.
-
- With no vaccine remaining in the medical arsenal, Glaxo
cautioned that the only alternative is for people -- especially those in
tick-infested areas -- to be vigilant for symptoms and to report them to
their doctors.
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