Vaccine taken off the mkt. because of poor sales-HUH?

Concerns (and Lawsuits) Grow Over Reactions to Lyme Vaccine

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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