Lyme Disease Vaccine

["Linda B. Merims" <lbm@ici.net>]

I saw this on the mtb-new-england list.  I have no idea whether the
assertion in the law suit has merit.

Linda B. Merims
lbm@ici.net
Linda_Merims@ne.3com.com
Massachusetts, USA


SmithKline Sued Over
Lyme Vaccine
>From Gayle Eversole <hrblgrbl@foxinternet.net>
>From Dawn Richardson <prove@vaccineinfo.net>
Company Press Release From Mealey Publications
12-14-99




WEST CHESTER, Pa. - A class action lawsuit filed today in Pennsylvania
claims the vaccine that prevents Lyme Disease causes an incurable form of
autoimmune arthritis and, for some, could produce symptoms far worse than
those brought on by the illness. ``Mealey's Litigation Report: Drug and
Medical Devices'' informed subscribers about the complaint today.

The complaint, filed in Chester County Court of Common Pleas, alleges
SmithKline Beecham (NYSE: SBH - news), manufacturers of the widely touted
LYMErix vaccine, failed to warn doctors and the general public that nearly
30 percent of the population was pre-disposed to a degenerative autoimmune
syndrome, which the lawsuit says is triggered by contents of the
inoculation.

``Once this autoimmune reaction is triggered, it cannot be cured and can
only be treated symptomatically for the remainder of the vaccine recipient's
life,'' the complaint says.

According to the class action, SmithKline (SBH) used high concentrations of
a surface protein called OspA as the foundation for its vaccine. When bitten
by a Lyme infected parasite, humans are not exposed to OspA protein. The
levels of OspA that enter the bloodstream at any phase of the three-dose
LYMErix vaccine, however, place patients classified by genetic type HLA-DR4+
at risk of developing a condition referred to as ``treatment-resistant''
Lyme Arthritis, the lawsuit says.

Despite this ``well documented relationship'' between OspA and
treatment-resistant Lyme Arthritis, SmithKline neglected to include the
information in its widely disseminated promotional literature and insisted
LYMErix was safe and generally well tolerated, the class action says.

About one-third of the general population is HLA-DR4+ and risks contracting
the arthritic condition when exposed to the vaccine, according to the
complaint. The HLA-DR4+ trait is easily detected by a routine blood test;
however, SmithKline never recommended that doctors screen for the trait
before administering the vaccine, the lawsuit alleges.

The complaint further alleges that patients who are infected with Lyme
bacteria when they receive LYMErix -- whether asymptomatic or in the early
stages of infection -- could suffer symptoms more progressive and enhanced
than if they had not received the vaccine.

SmithKline, the class action says, also neglected to inform doctors and the
general public that periodic booster shots beyond the series of three
vaccinations would be necessary to maintain immunity to the disease.

The class action includes counts of negligence, unfair trade practices and a
bid for medical monitoring of those who are placed at risk of developing
autoimmune arthritis but have not yet been diagnosed with the condition.

The class action complaint was filed by Stephen A. Sheller and Albert J.
Brooks Jr. of Sheller, Ludwig & Badey in Philadelphia.

Sheller said that in the wake of filing the class action, he expects to file
claims on behalf of individuals who received the LYMErix vaccine and are now
suffering from the autoimmune arthritis.


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