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Last updated January 1, 2014

Debate Rages Over Lyme Disease Vaccine

Debbie Carvalko, CBS HealthWatch, April 2001

April 24 (CBS HealthWatch)--They are two doctors: an orthopedic surgeon and a respiratory therapist. Both were healthy. Both volunteered to be inoculated with a Lyme Disease vaccine approved by the federal Food and Drug Administration (FDA). But within 24 hours of getting a second dose of the vaccine, LYMErix, both men had severe swelling and arthritis in their hands.

"And we have no reason to believe that it was anything but the vaccine involved in the development of arthritis," explained Paul Fawcett, MD, Director of the Immunological Laboratory at the Alfred I. DuPont Institute in Wilmington, Delaware, in a speech at the 14th International Conference on Lyme Disease and Other Tick-Borne Disorders, held April 21-23 in Farmington, Connecticut.

"Unless you are in a very high risk group, I would not get this vaccine. Put it this way," he added, "I could have gotten it for free, but I didn't." About 200 listeners--including doctors, nurses, scientists and Lyme sufferers, some of the latter attending in wheelchairs or aided by canes--applauded his advice.

While LYMErix was not the only topic discussed this past weekend at the international scientific conference on Lyme Disease, it was the prime subject stirring ire for professionals and patients alike. When pharmaceutical giant SmithKline Beecham sought approval in 1998 to distribute the vaccine, several members of the FDA's advisory board expressed strong concerns that LYMErix could for some people actually cause Lyme-related arthritis and other symptoms. But the vaccine was approved anyway.

"The bottom line is monkey business at the federal level pushed this vaccine through, not giving it fair and balanced and scientific consideration," claims Karen Vanderhoof-Forschner, founder of the national Lyme Disease Foundation and author of the book, Everything You Always Wanted to Know About Lyme Disease (John Wiley & Sons, 1997).

The U.S. General Accounting Office, an investigative arm of Congress, has launched an investigation into whether some members of the FDA advisory committee that approved LYMErix had "conflicts of interest," or financial factors that might have motivated their approvals.

"That is one of the issues we are examining," confirmed GAO Assistant Director Marcia Crosse.

Some already have their minds made up. "Absolutely, it was political. You can make a lot of money with vaccines," says Janet Humes, a 44-year-old geologist and member of the Massachusetts Lyme Disease Advisory Council to the state Department of Public Health. "We are all lab rats," adds Humes, who contracted Lyme from a tick 25 years ago.

Distribution of LYMErix began in January 1999. About 1.3 million doses have been sent to doctors' offices. There is no information on how much is still sitting on shelves and how many have actually been vaccinated, but a company spokesperson said it is assumed some 400,000 people have gotten the vaccine, which is given in three doses over a year.

But more than a 1,000 previously healthy people who received LYMErix developed disorders after being vaccinated, experts at the conference say. The complaints range from arthritis to paralysis, partial blindness, fatigue and "brain fog" or confusion.

There's no direct evidence that LYMErix is responsible. Still, some are calling for its removal or a moratorium on its use until long-term studies can be completed.

Lyme Disease, first recognized in the 1970s and traced to ticks, has since become the most common insect-borne disease in the United States. Within days of being bitten, a victim usually develops a bull's-eye rash at the site. Symptoms include joint pain, nerve palsy, chills, fever, headache and fatigue. In most people, early stage Lyme can be cured with antibiotics. Left untreated, Lyme can lead to conditions including debilitating arthritis and mental disturbances.

Yet, if it is generally treatable with antibiotics, why take a chance with a vaccine? Some tick bites go unnoticed, said James Miller, MD, a microbiology and immunology professor at the University of California at Los Angeles. "By the time the person comes in and gets a diagnosis, they may already have arthritis," he warns. But would he line up for LYMErix? "No, I wouldn't take it," says Miller.

SmithKline says the concerns about LYMErix are all unfounded, though.

"We have every confidence in the safety and efficacy of this vaccine," said company spokesperson Carmel Hogan.

"There is no scientific evidence" that the illnesses recipients are developing are a result of the vaccine, she added. Indeed, SmithKline has applied for approval to give the vaccine to children. LYMErix is now approved only for people aged 15 to 70.

Bernard Hoet, MD, a physician for SmithKline, said data show the number of people developing arthritis and other maladies after the vaccine is no greater than it is in the general unvaccinated population. "We do not consider arthritis cases (to be) associated with the vaccine," said Hoet.

And even some doctors who say they've seen recipients develop "what seems to be identical to chronic Lyme" say that doesn't mean all efforts with LYMErix should be halted.

"I'm not sure we should throw the baby out with the bathwater," said Sam Donta, MD, of the Boston University School of Medicine. "The FDA should have made a decision to be a little more cautious with its recommendations for the vaccine."

©2001 by Medscape Inc.


For a reality check, read Common Causes' Marjorie Tietjen's article, Challenging Quackwatch’s Position on Lyme Disease




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