E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

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 3^rd 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 1^st dose but was given a 2^nd 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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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.