[at-l] Lymerix taken off the market

[dfaddleton@mindspring.com (David)]

These drug companies could use some help naming their products

I mean, really, how seriously can you take a vaccine named Limericks?




> Hot off the press, AP newswire:
>
>
> Vaccine Maker Pulls Drug Off Market
>
> 02/26/2002 5:31 PM EST
>
>   By LAURAN NEERGAARD
>
> 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.
>
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