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Federal health authorities are currently investigating
whether the Lyme disease vaccine, Lymerix, caused severe
cases of arthritis and even Lyme
disease itself in some people, according to a recent
report in the New York Times.
Until now, the government was actively investigating
illnesses that broke out after vaccination only if they were officially
classified as serious defined as life-threatening, persistent and long-term
or requiring hospitalization. Lyme disease and arthritis were not generally
regarded as meeting those criteria.
Researchers from both the FDA and the disease-control
centers will now investigate all cases of arthritis and all symptoms of
Lyme disease reported to have developed after a patient has been vaccinated,
Dr. Susan S. Ellenberg, director of biostatistics and epidemiology at
the FDA said.
The FDA had approved the vaccine made by SmithKline
Beecham Biologicals, about two years ago, and about 440,000
Americans have received it so far. The company maintains that the shot
is safe.
Dr. Ellenberg, said the FDA, working with the CDC,
would investigate the reports "to find out what the cases really
are, to get more information." Dr. Ellenberg and Dr. Walter A. Orenstein,
assistant surgeon general and director of the centers' national immunization
program, said it remained to be determined whether the vaccine was the
cause of the reported illnesses.
When the FDA's vaccine advisory committee recommended that the vaccine
be approved for marketing, several
members expressed concern that the vaccine could set off an autoimmune
condition that, in turn, would result in arthritis.
Some also said they feared it
could cause flare-ups of Lyme disease among people previously infected
with the Lyme bacteria, Borrelia bergdorferi.
Physician Opposition
The New York Times report claims that in interviews,
"more than a dozen doctors in areas where Lyme disease is common
say they have treated 170 people with arthritis and Lyme disease that
they attribute to the vaccine."
Some doctors say the drug agency should
never have approved the Lyme vaccine or
should have responded more quickly to adverse reports. Dr. Andrea Gaito,
a New Jersey rheumatologist and president of the International
Lyme and Associated Disorders Society, said she had told the agency
that 21 patients developed severe arthritis soon after being given the
vaccine by other doctors, according to the Times report.
Dr. Gaito, who does not give the vaccine, said she
believed that the vaccine caused arthritis and Lyme disease itself but
that the problems were not always linked to it because the vaccine took
effect only after three shots given over the course of a year. "The
FDA had just better withdraw this vaccine now," Dr. Gaito
said.
Dr. Charlene C. Demarco of Egg Harbor, N.J., an
internist and family doctor, said 50 of her patients had developed autoimmune
arthritis after receiving Lyme vaccine from other doctors and 30 others
appeared to have flare-ups of previous Lyme infections. She maintains
that the FDA did not moved quickly enough after initial
reports of adverse effects.
Dr. Ellenberg from the FDA conceded that they had
at times acted too slowly. "We wish that some of these cases had
been brought to our attention sooner," she said. "They
should have been given a higher priority."
Despite the fact that the FDA's vaccine advisory
committee eventually recommended approval of Lymerix, the panel's chairwoman,
Dr. Patricia L. Ferrieri of the University of Minnesota Medical School,
said it had taken the action with unusual "ambivalence" because
of concerns about the possibility of severe reactions.
Autoimmune Reaction
Dr. Allen C. Steere, who directed SmithKline Beecham's
trials of the vaccine, told the committee that it
was hypothetically possible that the vaccine could set off an autoimmune
reaction in which the body's immune system attacks its own tissue,
and that this could cause treatment-resistant arthritis.
In addition, Dr. Steere had expressed the concern
as early as 1995, shortly after the start of the clinical trials, when
he said that some patients were already developing joint
pain after getting the vaccine. "A small percentage of
patients have developed joint pain and arthritis following vaccination,"
Dr. Steere said in a letter to the National Institutes of Health.
In July 1998, two months after Dr. Steere recommended
the vaccine's approval, he and colleagues reported in the journal Science
that they believed they had found the cause of the adverse effects. They
discovered that a piece of protein on the outer surface of the Lyme bacteria
was strikingly similar, to a natural human protein in blood and other
cells. This raised
the theoretical possibility that when an infected tick bites a human,
the person's immune system T-cells, the soldiers on the front line of
the body's defense against disease, could destroy not only the foreign
invader but also some of the body's own protein.
Legal Action
About 60 patients who believe they were made ill
by the Lyme vaccine are suing SmithKline Beecham for monetary damages,
said Stephen A. Sheller, a lawyer with Sheller,
Ludwig & Badey, of Philadelphia, which is handling the suits.
And class-action suits have been filed by the firm in New York, New Jersey
and Pennsylvania seeking to require the company to warn doctors and patients
that it poses possible risks for those who are genetically predisposed
to autoimmune arthritis or who have been previously infected with Lyme
bacteria.
To see the complete text of the Lymerix complaint
filed against SmithKline Beecham go to http://www.sheller.com/complaint.htm.
New
York Times November 21,
2000
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