[at-l] Lymerix taken off the market

[thornel@attglobal.net (W F Thorneloe)]

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.