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No warning on new Lyme disease vaccine downside

Thursday, 9 March 2000 16:25 (ET)

NEW YORK, March 9 (UPI) -- The new vaccine for Lyme disease has
caused 298 adverse reactions, including chronic arthritis, according to
reports obtained by Newsday, but there's no warning on the drug's label
that this could happen.

Newsday said Thursday it obtained the reports from the Food and Drug
Administration under the Freedom of Information Act.

Some 600,000 people took the drug, produce by SmithKline Beecham
Pharmaceuticals of Philadelphia as LYMErix, the newspaper said, so the
number of adverse reactions is small. However, the reports said apart from
the arthritis, which is similar to rheumatoid arthritis, most reactions were
allergic reactions. About one-third of the patients taking the drug who
experienced the bad reactions ended up in the emergency room.

Spokespeople for the FDA and SmithKline say the reports did not reliably
link the drug to subsequent complications.

However, lawsuits have been filed against the drug maker, including a
class action suit in Philadelphia, charging that SmithKline failed to warn
doctors and the public that the vaccine puts certain people with specific
genetic traits "to the risk of a chronic, degenerative and incurable
autoimmune disease which is much greater than the risk posed to these
individuals by an ordinary Lyme-carrier tick bite."

The suits are asking that the company re-label its warning on the vaccine,
that it advise doctors to screen patients for potential risk and pay for blood
screening for those who have taken the drug, to see if they are still at risk.

LYMErix causes the immune system to produce antibodies to a protein on
the surface of the Lyme disease bacterium B. burgdorferi, but researchers
found that part of surface protein called OspA, could possibly cause a
reaction in certain individuals with a specific gene, the HLA-DR4 gene.

Karen Vanderhoof-Forschner, chairwoman of the board of directors of the
nonprofit Lyme Disease Foundation in Hartford, Conn., told Newsday: "I'm
stunned. Looking at these data, I'm highly concerned by the number of the
reactions and the severity of the reactions. ... This is a voluntary reporting
system, so this is probably the tip of the iceberg. How is the public
supposed to evaluate this data?" -- Copyright 2000 by United Press
International. All rights reserved.

------------------------------------------------------------------------
Steve Wingate

California Director
SKYWATCH INTERNATIONAL

Anomalous Images and UFO Files
http://www.anomalous-images.com

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