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E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
Vienna, Virginia http://www.909shot.com
"Protecting the health and informed consent rights of children since
1982."
=============================================
Commentary by Kathi Williams
Co-Founder and Vice President
The National Vaccine Information Center
February 6, 2001
"I dare you," challenged a health care worker from Maryland as she
addressed the Food and Drug Administration's Vaccines and Related Biological
Products Advisory Committee in a January 31 public hearing forum called by the
FDA. "I dare you to take the first dose of the Lyme vaccine. I did. It was given to me while I had an
active Lyme infection. My doctor told me it was perfectly safe. My life has
never been the same."
This health care worker was one of nearly 20 people who traveled from all over
the eastern United States to relate their heartbreaking stories of severe
arthritis, extreme fatigue, muscle weakness and paralysis, vision and memory
loss and other kinds of automimmune and neurological dysfunction after
vaccination with SmithKline Beecham's Lymerix vaccine. Linda came on behalf of
her daughter, Vanessa who was given the vaccine when she was 17 years old. Her
mother worried that because she was around horses and animals she would be at
risk of a Lyme infection from a tick bite. Vanessa had a simple case of Lyme
disease when she was 12. Following the second dose of vaccine she developed
ankle pain and many other vague complaints in her other joints. Within weeks
she woke up with peripheral blindness. She spent her senior year at home being
too sick to attend school. She missed her senior prom and her dream of becoming
a veterinarian may remain only a dream.
Lynn, who also reacted to Lyme vaccine, described how she was in the clinical
trial for the vaccine and became ill. She and her whole family had chronic Lyme
Disease but still tested negative. Smith Kline Beecham lost her records. She
says that antibiotics have helped but she wishes she could go back to just
living with the infection because the side effects of the vaccine have been so
devastating.
John is a 65-year old man who led a very active outdoor life style but
following the 3rd dose of Lyme vaccine he could not get out of bed. He still
suffers with joint pain and stiffness.
Pat described how his wife Sue, 17 years his junior, had mild symptoms after
the 1st dose but was given a 2nd dose and her symptoms worsened. She is now
losing her eyesight and her mental capacity. Pat reported the reaction to VAERS
but it took him 18 months to learn about the VAERS system.
Karen Vanderhoof-Forschner, founder of the National Lyme Disease Foundation,
presented documents to the committee that showed Lymerix vaccine is reactive,
especially in individuals with genetic predisposition to rheumatoid arthritis
and autoimmunity and those who have had Lyme disease or have an underlying Lyme
infection. Karen founded the foundation following the death of her five year
old son from Lyme Disease. She was a strong supporter of the Lyme vaccine
before she discovered how reactive it is.
Most of the victims called for a moratorium on the use of Lymerix but, at the
very least, are calling on the SmithKline Beecham and the FDA to strengthen
warnings in the product manufacturer insert. They also do not want Lymerix to
be used in young children in its current form.
After listening to the testimonials which took nearly two hours, Barbara Loe
Fisher, president and co-founder of the National Vaccine Information Center and
the consumer voting member of the FDA committee, said "Different disease.
Different vaccine. Same story" and added "The willingness of industry
and doctors to dismiss all adverse events following vaccination as coincidental
is widespread and it absolutely impacts on vaccine adverse event reporting to
VAERS...The number one high risk factor that we at the
National Vaccine Information Center have identified after 19 years of taking
vaccine adverse event reports is doctors continuing to vaccinate after vaccine
reactions and deterioration in health." She called for labeling changes
and strengthening of informed consent protections in the product manufacturer
insert, including stronger contraindications; basic science research into
genetic and other biological high risk factors and active surveillance of
vaccine adverse events.
Most of the doctors on the committee also were not satisfied that questions
about the safety of the vaccine had been adequately answered by the
manufacturer and pointed out that the same questions they had at the time of
licensure remained. They called for more data to be generated immediately.
One member, Dr. Patricia Ferrieri, who was the chair of the FDA Committee in
1988 when the vaccine was licensed, said that her concerns about safety were
greater now than two years ago when the vaccine was licensed. "The FDA has
to grapple with the issue of is it sufficient to re-do the package
insert," she said,and asked, "how far will the FDA have to be pushed
or should you put a moratorium on the vaccine? It is with great regret that we
never heard these types of concerns iterated without agency response. There
are too many "ifs" for us to feel secure that the answer will be
forthcoming."
Jenny Marra cried softly in the back of the room at the end of the meeting,
disappointed that the FDA did not ask the Committee to vote on whether to stop
the vaccine. "More people will be injured and they will be calling
me."
Committee member, Dr. O'Fallon, said there is too much evidence that something
is going on. "No," he said in answer to the earlier challenge,
"I would not take this vaccine."
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Breaking News Archives - each day's breaking news from December 1, 2003 (check here for breaking news you might have missed and breaking news that didn't ever hit the "front page")
More News - all the news most recently posted on this website
All the News - a running tab of everything posted on this website since October 29, 2003
Top Stories Archives - daily breaking and other important news stories
Daily News Archives - all the news posted on this website each day (from April 2001)
Hot Topics - selected stories, by category
Return to Vaccination News Home Page (for best results, right click to "open in new window")
DISCLAIMER: All information, data, and material contained, presented, or provided here is for general information purposes only and is not to be construed as reflecting the knowledge or opinions of the publisher, and is not to be construed or intended as providing medical or legal advice. The decision whether or not to vaccinate is an important and complex issue and should be made by you, and you alone, in consultation with your health care provider.