Food and Drug Administration (FDA) advisers on Wednesday said they had
been given too little new data to determine if a Lyme disease vaccine
might cause autoimmune arthritis.
The FDA asked its Vaccines and Related Biological Products Advisory Committee
to examine the most recent data on Glaxo SmithKline's LYMErix.
A majority of panelists said the data did not shed
new light on concerns raised before approval.
Patricia Ferrieri, a panel consultant and former committee member from
the University of Minnesota Medical School, noted an increase
in side effect reports and testimony from a vocal group of
people who received the vaccine, many of whom claimed they developed
autoimmune arthritis from LYMErix.
Barbara Loe Fisher, the panel's consumer representative, urged the agency
not to ignore these anecdotal reports. "We cannot continue to dismiss
these as coincidental events," said Fisher, president of the National
Vaccine Information Center.
Glaxo SmithKline has distributed 1.4
million doses of LYMErix, but it did not estimate how
many people might have received the vaccine, delivered in three to five
shots over the course of a year.
The agency has received 1,048 reports
of events potentially related to LYMErix, including 133 reports
of arthritis or arthritic-type symptoms. Robert Ball of the FDA said that,
so far, they do not provide clear evidence that LYMErix had caused the
effects.
There were more reports in 2000 than in 1999. The uptick might be due
to a late onset of symptoms, or news stories suggesting a link between
the vaccine and arthritis, Ball said.
The agency is hoping to get to the bottom of the issue. It is interviewing
people who reported symptoms and will compare them with other vaccine
recipients in the FDA database.
A pregnancy registry for human vaccine recipients and reproductive toxicity
trials in rats showed no unexpected events in mothers or fetuses, said
Glaxo SmithKline. But panelists were not convinced;
one noted a high rate of abortions.
Steven Sheller, a Philadelphia attorney representing vaccine recipients
who claim they got arthritis from LYMErix, called for a moratorium on
LYMErix sales until more information was gathered. Consumer advocate Sidney
Wolfe, director of Public Citizen
Health Research Group, urged FDA to change LYMErix labeling to highlight
potential problems.
New York Times February 1, 2001
