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KWilliams Note: THIS IS A VICTORY FOR VACCINE SAFETY
Glaxo withdraws its Lyme disease vaccine
Treatment is still safe, but demand too low
Tuesday, February 26, 2002
The Lyme disease vaccine, dogged by safety questions since
it became available three years ago, was discontinued yesterday by its
GlaxoSmithKline Plc cited insufficient demand for its
decision to yank Lymerix, which was initially hailed by doctors and public-
health officials as a breakthrough in combating a notorious bacteria that
claims up to 16,000 victims each year.
Instead, Lymerix was blamed for causing the kind of
arthritic symptoms it was supposed to prevent. In its first two years on the
market, the vaccine prompted 905 adverse-event reports, such as swelled joints
and aching muscles. Dozens of lawsuits are pending.
A Glaxo spokeswoman said the controversy didnt play a
role in the companys decision. Neither, she said, was the move made in
response to pressure from regulators, which a Food and Drug Administration
Safety wasnt a factor in our decision, said Ramona
Dubois, a spokeswoman for Glaxo, which inherited Lymerix last year after buying
the vaccines original manufacturer, SmithKline Beecham.
Despite our best efforts, demand hasnt reached a
sustainable level. The market just wasnt there, she said.
Glaxo also is withdrawing an application with regulators
to market a pediatric version, she said. The company has halted all research into
At the time the FDA approved Lymerix in late 1998,
SmithKline touted the vaccine as a driver of growth. But 1999 sales were a
disappointing $40 million and the ensuing negative publicity caused sales to
plummet, although more recent figures arent available.
The controversy also engulfed the FDA, which was
criticized for approving the product, given that a protein used to make the
vaccine may produce an untreatable form of severe arthritis in people with a
commonly held gene.
The decision was a victory for consumer advocates, who
have been lobbying the FDA to force Glaxo to withdraw Lymerix.
It should have never been approved in the first place,
said Karen Forschner of the Lyme Disease Foundation, a nonprofit that recently
obtained clinical-trial data that she said raised questions about the extent to
which side effects were recorded properly.
It was based on bad science. Its a crummy vaccine thats
probably caused significant injury to people, but information wasnt shared
with the FDA or the public, she said. This decision will probably save
thousands of people from having similar problems.
Barbara Fisher, who sits on the FDA advisory panel that
last year heard testimony from people claiming injury from Lymerix, agreed that
Glaxos decision to discontinue the vaccine was overdue.
The evidence has been compelling for some time, said
Fisher, who also heads the nonprofit National Vaccine Information Center. The
science says that certain people are vulnerable to this product.
The Glaxo spokeswoman said doctors can contact the drug
maker for instructions on returning unused doses. She noted, however, that
doctors arent being told not to vaccinate patients.
Stephen Sheller, an attorney who represents about 350
people claiming harm from Lymerix, said the lawsuits will proceed.
Ed Silverman can be reached at firstname.lastname@example.org
or (973) 392-1542.
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