Hi All;
I have always avoided vaccines like the plague. (No play on words here) The one exception being the Pneumovax vaccine to prevent pneumonia. Pneumonia is a killer for the elderly and immune supressed.
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Did Lyme Vaccine Give
People The Disease & Arthritis?
Concerns Grow Over Reactions to Lyme Shots
By Holcomb B. Noble
NY Times
11-21-00
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.
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.
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.
"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.
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.
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.
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.
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.
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."
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.
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.
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.
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.
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.
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.
Dr. Demarco said the agency had not moved quickly
enough after initial reports of adverse effects.
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.
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.
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.
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.
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.
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.
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.
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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Phil Sr.
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