H. Noble Lymerix article in today's NY Times (long)
A.J.
Holc Noble strikes again, bless his heart! Write to the Times about
this article. Tell them your Lyme vaccine story if you have one, even
if it is about your pets. Tell them that because there is no truly
accurate test for Lyme there is *no way* to be sure that the vaccine
is being given to someone free of Lyme infection and thus the test is
inherently unsafe. Tell them thank you for the story if nothing else.
And if you want your letter published, keep it under 150 words, and be
sure to include your name, address, phone number and email addy.
Amy in CT.
-------------------------------------------------------------------------------------------------------------
Concerns Grow Over Reactions to Lyme Shots
By HOLCOMB B. NOBLE
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, 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.
Joel M. Shmukler, Esq
A.J. <live...@snet.net> wrote:
> November 21, 2000
>
> Concerns Grow Over Reactions to Lyme Shots
> By HOLCOMB B. NOBLE
>
> 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.
For a comprehensive discussion of Safety & Efficacy Concerns relating
to the Lyme Vaccine (and lots of links) see:
http://www.aero-vision.com/~cheryl/vaccine.html
--
Joel M. Shmukler, Esquire, Director LYMECURE
Sent via Deja.com http://www.deja.com/
Before you buy.