- Federal health authorities are investigating whether
some people who received the vaccine against Lyme disease later developed
severe cases of arthritis and even Lyme disease itself as a result.
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- The Food and Drug Administration has received reports
of such problems, mainly from doctors and researchers in the Northeast.
The vaccine, made by SmithKline Beecham Biologicals, a subsidiary of the
British pharmaceutical giant SmithKline Beecham, was approved by the drug
agency two years ago, and about 440,000 Americans have received it. SmithKline
Beecham defends it as safe.
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- Dr. Susan S. Ellenberg, director of biostatistics and
epidemiology at the F.D.A., said the agency, working with the Centers for
Disease Control and Prevention, 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.
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- "We have a vaccine that provides considerable, proven
benefit , about 80 percent protection against Lyme disease and only theoretical
risk with respect to arthritis," Dr. Orenstein said.
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- As a first step, the investigators will seek to determine
whether, over all, vaccine recipients report arthritis or Lyme disease
more often than people who have not received the vaccine. Until that initial
step is taken, there is no evidence that the vaccine causes problems.
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- There is no way to determine how many people believe
they have developed health problems caused by the vaccine. But 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.
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- According to SmithKline Beecham, the vaccine was tested
in controlled, double-blind clinical trials involving 10,936 people; after
two years, those who were vaccinated were not reported to have suffered
any more illnesses than those who were not.
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- But when the drug agency'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.
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- Ultimately, in May 1998, the advisory committee endorsed
the vaccine unanimously, concluding that the concerns were only theoretical
and that data gathered in the clinical trials showed that the vaccine was
safe. Carmel Hogan, a spokeswoman for the company, said of the vaccine:
"Lymerix is the only clinically proven vaccine to protect against
Lyme disease and both the F.D.A. advisory committee and the F.D.A. Office
of Vaccines have determined that the vaccine is safe."
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- Until now, the government was actively investigating
illnesses that broke out after vaccination only if they were officially
classified as serious ,Äî defined as life-threatening, persistent
and long-term or requiring hospitalization. Lyme disease and arthritis
were not generally regarded as meeting those criteria.
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- Researchers from both the drug agency 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. Ellenberg said. The cases under investigation are concentrated in seven
states: Delaware, New Jersey, Pennsylvania, Connecticut, New York, Massachusetts
and Wisconsin.
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- Dr. Orenstein likened the new investigations to those
begun in the fall of 1998 after the licensing of the rotavirus vaccine
against childhood gastroenteritis. Within six months, doctors reported
15 cases of intestinal blockages among vaccinated infants; though the number
of cases was small, the rate was so much higher than normal that the drug
and disease-control agencies declared a moratorium on the vaccine's use
while the investigation continued. In October 1999, 98 cases cases had
been reported and the manufacturer, American Home Products of Madison,
N.J., withdrew the vaccine from the market, Dr. Orenstein said.
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- 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.
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- 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 immunization shots given over the course of a year. "The
F.D.A. had just better withdraw this vaccine now," Dr. Gaito said.
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- 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.
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- Dr. Demarco said the agency had not moved quickly enough
after initial reports of adverse effects.
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- Dr. Ellenberg conceded that the drug agency 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." She said "we have made that clear" to
the unit that takes in the reports and records the medical data.
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- Still, other doctors and clinicians challenged the suggestion
that the 170 people who developed problems suffered them because of the
vaccine. "I would say, `Show me the data,' " said Dr. Gregory
A. Poland, chief of vaccine research at the Mayo Clinic in Rochester, Minn.
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- Even though the vaccine advisory committee 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.
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- 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.
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- 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.
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- "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.
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- As far back as 1989, Dr. Steere and research colleagues
found that people with what they called prolonged, treatment-resistant
Lyme arthritis often carried a gene variant called HLA-DR4. The suspicion
was that among those people, some chemical component in their joint tissue
resembled a chemical in the invading Borrelia bergdorferi. This, it was
thought, could cause the immune system to attack a person's own tissue
along with the foreign bacteria.
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- 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 guilty molecular twins: a piece of
protein on the outer surface of the Lyme bacteria was strikingly similar,
they said, 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.
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- Some 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.
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