The truth comes out- Lyme Vaccine Pulled Off Market

Lyme Vaccine Pulled Off Market

By LAURAN NEERGAARD
..c The Associated Press

WASHINGTON (AP) - The maker of the nation's only Lyme disease vaccine
pulled it
off the market Tuesday, citing poor sales.

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

But after a year of investigation, the Food and Drug Administration had
found
no proof that the vaccine was dangerous and thus did not tell the
manufacturer
to end sales, an agency spokeswoman said Tuesday.

``The reason is there's just no demand for it,'' said GlaxoSmithKline
spokeswoman Ramona Dubose.

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 thus decided it didn't
make
financial sense to keep selling, Dubose said.

The company's decision comes less than a month after federal health
officials
warned that Lyme disease cases had reached record highs in recent
years.

Lyme disease, spread by deer ticks in the Northeast and certain other
parts of
the country, causes fatigue, fevers and joint pain that can persist for
weeks.
Some patients develop severe arthritis. If untreated with antibiotics,
it also
can severely damage the heart and nervous systems.

Lyme sufferers begged the FDA to approve Lymerix, the world's first
Lyme
vaccine, in 1998. It required two shots given about a month apart and a
third a
year later to get about 80 percent protection from Lyme disease.

But some patients reported arthritis, muscle pain and other troubling
symptoms
after vaccination. Some also claimed doctors hid information about
possible
side effects before administering the vaccine, and then often dismissed
symptoms.

Many of the alleged symptoms were similar to Lyme disease itself. While
the
vaccine is 80 percent effective, it's not that protective until all
three doses
are given - meaning some people with symptoms could have Lyme instead
of a
vaccine reaction. Or, because arthritis is so common that 15 percent of
the
population is afflicted, they could have arthritis unrelated to
vaccination.

In one safety study, 5,000 people got Lymerix and another 5,000 got
dummy
shots. Two percent of each group developed arthritislike symptoms,
reassuring
to the FDA.

Still, the Centers for Disease Control and Prevention re-examined all
905
possible side effects reported to the government between 1998 and July
2000, to
see if regulators had missed any signs of real trouble.

The CDC's results, just published in the journal Vaccine, found no
signs that
arthritis or other side effects were being caused by the Lymerix
vaccine. It
did, however, find 22 cases of allergic reaction to the vaccine, and
said
scientists would continue to assess reported side effects closely.

AP-NY-02-26-02 1148EST

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