AB
News
http://www.abcnews.go.com/sections/living/DailyNews/lyme_vaccine0516.
html
Lyme disease - Vaccine Victims?
The Controversy Surrounding SmithKline Beecham s LYMErix
Lyme disease is an infection caused by bacteria that live in deer
ticks. As
summer heats up and people head for the woods, LYMErix vaccinations
may be
popular. But dome doctors now say LYMErix may do more harm than
good. (Art
Today)
Ephrat Livni
ABCNEWS.com
N E W Y O R K, May 17 Edward James Schneider, an avid gardener,
only
wanted to help his fellow hobbyists.
In the spring of 1995, Schneider, 60, of Poughkeepsie, N.Y.,
agreed to
participate in the city's Health Department testing of a vaccine
against
Lyme disease, an illness that commonly afflicts people who spend a
lot of
time outside in wooded areas. His doctor said the vaccine carried
little or
no risk.
But six weeks after he received his second shot of LYMErix,
licensed
by Yale University and produced by drug giant SmithKline Beecham,
headquartered in Philadelphia, Pa., Schneider lay paralyzed on his
bedroom
floor, desperately in need of help himself.
I would just like to know what the heck I have because I have
always
been very healthy, says Schneider, who experienced, fever and an
intense,
hellish pain, that day and for six weeks after. He continues to
suffer
from arthritis, numbness and widespread tingling.
Schneider is one of more than 70 plaintiffs in Karen Cassidy
et al.
vs. SmithKline Beecham, a Pennsylvania class action suit alleging
SmithKline Beecham failed to warn doctors and the public that nearly
a
third of the general population is genetically predisposed to a
non-treatable degenerative disease known as autoimmune arthritis
triggered by the vaccine.
While the drugmaker and the Food and Drug Administration allege
the
vaccine does not present enough adverse effects to raise a red
flag,
evidence to the contrary is mounting.
Difficult to Diagnose
Lyme disease, an inflammatory infection caused by B. Burgdorferi
bacteria
that live in deer ticks, was recognized and named in 1975 in Lyme,
Conn.
Since then, the disease has appeared in 47 states. It usually occurs
in the
summer and early fall after bacteria from deer ticks, which bite
humans,
enter the skin and spread through the blood to organs and other skin
sites,
causing inflammation, fatigue, chills and fever.
Lyme disease is often difficult to diagnose because its
symptoms are
similar to those of arthritis, influenza and mononucleosis.
According to
the Centers for Disease Control more than 139,000 cases of the
disease have
been reported since the agency began monitoring it in 1992.
LYMErix is the first Lyme disease vaccine approved by the FDA.
Since
its launch in January, 1999, SmithKline Beecham says more than 1
million
doses of LYMErix have been distributed to health departments,
hospitals,
doctors and clinics, though the company has no record of how many of
those
doses have been administered or how many people have actually been
vaccinated.
The key ingredient in LYMErix is a genetically engineered
protein from
the surface of the bacteria B. Burgdorferi that helps stimulate an
immune
response against the bacteria. The protein, called OspA, stimulates
antibodies that disable B. burgdorferi bacteria s ability to infect
people.
Protein Triggers Genetic Marker
Originally hailed as protection from the debilitating Lyme disease,
some
doctors are now saying LYMErix may do more harm than good in some
people
because of the OspA protein.
According to a report from Quest Diagnostics, a major lab in
Horsham,
Pa., about 30 percent of the general population is a genetic type
called
HLA-DR4+. Dr. Christine DeMarco, a member of the New Jersey Governor
s
Council on Lyme Disease, says OspA triggers autoimmune arthritis in
individuals with this genetic marker.
SmithKline has made no effort to make doctors aware of this,
DeMarco
says. Because of the prohibitive cost of testing for HLA-DR4+
about
$300.00 she claims the drug company does not tell physicians of
the
preventable risk patients take when choosing to be vaccinated.
According to DeMarco, patients who live in Lyme areas now know
what to
do to prevent the disease, such as wearing protective clothing and
checking
for ticks. Even at late stages, though, Lyme can be treated, while
autoimmune arthritis cannot.
Several people have become disabled and will continue to
degenerate,
says Steven Sheller of Philadelphia,, the lawyer in the class action
suit
against SmithKline Beecham. These are outdoor people, healthy
people. So
we are taking people amongst our healthiest population and putting
them at
risk.
Drugmaker Denies Claims
While the drug maker says it cannot comment on specific cases,
SmithKline
spokeswoman Carmel Hogan did remark: A pivotal efficacy trial for
LYMErix
was conducted and the data was presented to a data safety board. The
board
found no evidence of an association between LYMErix and autoimmune
arthritis. In addition, we as a company are not aware of any other
human
data that established a causal connection between LYMErix and
autoimmune
arthritis.
FDA spokeswoman Lenore Gelb agreed, saying, We have been
monitoring
adverse events and we don t see any red flags. To date 274 cases of
adverse effects have been reported to the FDA. But, according to Dr.
DeMarco, many cases like Schneider s may go unreported because
doctors
do not make the connection between the vaccine and patients
symptoms.
The Health Commissioner for Duchess County, N.Y., Dr. Michael
Caldwell
also says the allegations against the vaccine are unfounded.
Caldwell is
also a practicing physician in an area where Lyme disease is
prevalent.
My feeling is that if that hypothesis [HLA-DR4+] was true we
would
have found evidence of it. As a public health preventive measure, I
feel
comfortable with it [the vaccine], said Caldwell, who was also one
of the
principal investigators of the original Lyme disease vaccine study
and
subsequent follow-ups.
Health Departments Differ
But Claire Pospisil, a New York State Health Department spokeswoman,
says
the department does not recommend the vaccine because it is
relatively new.
She added that department officials are neither aware of the HDL-A4+
matter
nor the lawsuit. The New Jersey Health Department, however, agrees
with the
CDC recommendation that the vaccine is a viable option for those
living in
Lyme-prone areas.
Tips for Personal Protection
Wear light colored clothing to spot ticks.
Wear long sleeved shirts, closed shoes and socks.
Tuck pants into socks and shirt into pants.
Walk in the center of trails.
Use insect repellant containing permethrin.
Once indoors, remove, wash and dry clothing.
Carefully remove any attached ticks.
Check pets for ticks.
For the moment, Cassidy vs. SmithKline Beecham is on hold while
the
company answers the complaint and looks at data Sheller has
compiled.
Meanwhile, Sheller says two or three new people a day call each day
to
inquire about joining the suit.
As summer heats up and more and more people head for the woods,
LYMErix vaccinations may be popular. For those thinking about
getting the
vaccine, Pospisil advises you consider your lifestyle. If you are
not a
landscaper it may not be worth it.
Patient For a Lifetime
A hospice nurse from Ocean, N.J., Jenny Marra, 41, has experience
with
doctors. But the past year has been different.
In May 1999, Marra received her first dose of the SmithKline
Beecham
Lyme disease vaccine LYMErix. She immediately experienced severe flu
symptoms, but was told her reaction was common. After her second
injection,
her elbows began to ache. The pain spread down her arms and
throughout her
body, until by November she could barely clasp a carton of milk, she
said.
Diagnosed with chronic fatigue, depression and fibromyalgia,
doctors
eventually suggested the inflamed joints, aching muscles and
accompanying
pain Marra was experiencing might just be job stress or her
imagination.
But Marra, who says she loves her job, knew that could not be true.
Serendipitously, in November she ran across a small magazine
blurb
about the Pennsylvania lawsuit Cassidy et al. v. SmithKline Beecham.
Her
symptoms matched the plaintiffs allegations, so she researched the
vaccine
and discovered a network of vaccinees experiencing the same pain.
Since then, she has been diagnosed with autoimmune arthritis,
an
untreatable, disabling form of arthritis. Marra, like 30 percent of
the
general population, is of a genetic type called HLA-DR4+. Some
experts say
a key ingredient in LYMErix triggers autoimmune arthritis in such
individuals.
Now, as Marra who cut down her work hours and changed her
lifestyle
looks ahead at a lifetime of being a patient, she says she will
fight the
drugmaker until the public is educated about LYMErix and the alleged
avoidable risks involved in taking it.
I want funding for research. They have to tell people, Marra
says.
As a nurse, I have always been a patient advocate and I won t back
down
now.
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