A Victory for Vaccine Safety Advocates
By Ed Silverman
The Lyme disease vaccine, Lymerix, dogged by safety questions since it became available three years ago, was discontinued February 25 by its manufacturer.
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.
Glaxo also is withdrawing an application with regulators to market a pediatric version. The company has halted all research into Lyme disease.
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 aren't 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. It's a crummy vaccine that's probably caused significant injury to people, but information wasn't 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 Glaxo's 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."
Stephen Sheller, an attorney who represents about 350 people claiming harm from Lymerix, said the lawsuits will proceed.
New Jersey Star-Ledger February 26, 2002
COMMENT By Dawn Richardson from PROVE:
The highly reactive Lyme Disease Vaccine has finally bitten the dust. It is important to note that no matter what the manufacturer cites for a reason, the truth is that because the vaccine never made it onto the childhood schedule, the manufacturer is not protected from liability under the National Vaccine Injury Compensation Program.
Many children and adults alike hurt by this vaccine have filed lawsuits and it is certain that many more are coming.
To the many victims that we have on our list, I am so sorry that it has taken this long, but your dedication to getting the truth out there has finally paid off. We are all grateful for your efforts.
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