Re: Steere: "Despite a lack of scientific evidence that the vaccine caused harm, the manufacturer withdrew it ... due to the threat of class-action lawsuits

On May 26, 12:43 am, the 3rd Man <derdrittemann2...@xxxxxxxxx> wrote:
On May 25, 4:40 pm, chronichel...@xxxxxxxxx wrote:





On May 25, 8:54 am, the 3rd Man <derdrittemann2...@xxxxxxxxx> wrote:

Steere, in an excerpt from a commencement address at Ohio Wesleyan,
states that the reason for the withdrawl of the vaccine was NOT "poor
sales" as has been previously, continuously reported...but a threat of
litigation.

Interesting, because normally, people do NOT withdraw, to my
experience,  due to the threat of litigation...

...they withdraw because of a threat of litigation under which they
may have some possible EXPOSURE...they withdraw in the face of threats
from which they might potentially face a finding of liability.

================================================================

http://commencement.owu.edu/2008Congratulations.html

"But science says no. Diagnostic tests based on scientific studies
fail to
show evidence of Lyme disease in most of these patients. Additionally,
5 studies
of pain and fatigue syndromes following Lyme disease reported that
placebo
treatment with a sugar pill gave similar results as long-term
antibiotics. If you
ignore scientific reality, if you twist it, if you wish for a
particular answer, you will
miss Mars and drift in space. Physicians, like myself, have said
“scientific
evidence does not support giving antibiotics for years for Lyme
disease”. They
have been denounced, threatened, and harassed.

No single medical advance has had a greater impact on human health
than vaccines. Although a small percentage of individuals have serious
side
effects from vaccination, vaccines in general are much, much less
harmful than
the infections they prevent. However, as with the Lyme disease story,
vaccines
have become a vehicle to explain a host of poorly understood
illnesses. People
have claimed passionately that a vaccine causes autism. Class-action
lawsuits
resulting from these claims threaten the vaccine industry.

And this is what happened to the Lyme disease vaccine. Over the past
decade, two drug companies did extensive studies concerning the
efficacy and
safety of a newly developed Lyme disease vaccine for human use. In
1998, the
FDA licensed the vaccine. But the Lyme disease counterculture said
“vaccination for Lyme disease made my symptoms worse”. Despite a lack
of
scientific evidence that the vaccine caused harm, the manufacturer
withdrew it in
2002 primarily due to the threat of class-action lawsuits. When
science and
medicine are divorced, our efforts lead nowhere; we drift in space".

“vaccination for Lyme disease made my symptoms worse”.

this part doesn't even makes sense. So the ones being vaccinated had
already symptoms??. I thought the idea of the vaccine (for the most
part) was prevention.- Hide quoted text -

- Show quoted text -

Honestly, I thought the whole thing was very odd...the very idea of
including some peculiar anecdotal rant about the failure of the
vaccine in a commencement address? Isn't the idea there. customarily
supposed to be full of optimism and the world is yours...go out and
make your mark...etc, etc...? Have to wonder what the grads and their
proud parents made of that whole deal?

And if you read the entire thing...there is this bit about Galileo and
the pursuit of scientific truth.

Now, if you want to follow THAT analogy...surely the man must realize
that HE is in the position of the Pope, deciding what is, and what is
not, "heresy", in terms of Lyme disease.

But somehow he manages to tie all of this in with an eye towards the
future exploration of Mars...

(Fair warning to any little green men... "MARTIANS" out there)! (LOL.
Inside joke).

Like I said, if the vaccine was pulled because of fear of litigation,
would seem likely to me that the legal departments were afraid of the
liability exposure.- Hide quoted text -

- Show quoted text -

*******************************************************************************************************
Concerns (and Lawsuits) Grow Over Reactions to Lyme Vaccine



Federal health authorities are currently investigating whether the
Lyme disease vaccine, Lymerix, caused severe cases of arthritis and
even Lyme disease itself in some people, according to a recent report
in the New York Times.

Until now, the government was actively investigating illnesses that
broke out after vaccination only if they were officially classified as
serious defined as life-threatening, persistent and long-term or
requiring hospitalization. Lyme disease and arthritis were not
generally regarded as meeting those criteria.

Researchers from both the FDA and the disease-control centers will now
investigate all cases of arthritis and all symptoms of Lyme disease
reported to have developed after a patient has been vaccinated, Dr.
Susan S. Ellenberg, director of biostatistics and epidemiology at the
FDA said.

The FDA had approved the vaccine made by SmithKline Beecham
Biologicals, about two years ago, and about 440,000 Americans have
received it so far. The company maintains that the shot is safe.

Dr. Ellenberg, said the FDA, working with the CDC, would investigate
the reports "to find out what the cases really are, to get more
information." Dr. Ellenberg and Dr. Walter A. Orenstein, assistant
surgeon general and director of the centers' national immunization
program, said it remained to be determined whether the vaccine was the
cause of the reported illnesses.

When the FDA's vaccine advisory committee recommended that the vaccine
be approved for marketing, several members expressed concern that the
vaccine could set off an autoimmune condition that, in turn, would
result in arthritis.

Some also said they feared it could cause flare-ups of Lyme disease
among people previously infected with the Lyme bacteria, Borrelia
bergdorferi.

Physician Opposition

The New York Times report claims that in interviews, "more than a
dozen doctors in areas where Lyme disease is common say they have
treated 170 people with arthritis and Lyme disease that they attribute
to the vaccine."

Some doctors say the drug agency should never have approved the Lyme
vaccine or should have responded more quickly to adverse reports. Dr.
Andrea Gaito, a New Jersey rheumatologist and president of the
International Lyme and Associated Disorders Society, said she had told
the agency that 21 patients developed severe arthritis soon after
being given the vaccine by other doctors, according to the Times
report.

Dr. Gaito, who does not give the vaccine, said she believed that the
vaccine caused arthritis and Lyme disease itself but that the problems
were not always linked to it because the vaccine took effect only
after three shots given over the course of a year. "The FDA had just
better withdraw this vaccine now," Dr. Gaito said.

Dr. Charlene C. Demarco of Egg Harbor, N.J., an internist and family
doctor, said 50 of her patients had developed autoimmune arthritis
after receiving Lyme vaccine from other doctors and 30 others appeared
to have flare-ups of previous Lyme infections. She maintains that the
FDA did not moved quickly enough after initial reports of adverse
effects.

Dr. Ellenberg from the FDA conceded that they had at times acted too
slowly. "We wish that some of these cases had been brought to our
attention sooner," she said. "They should have been given a higher
priority."

Despite the fact that the FDA's vaccine advisory committee eventually
recommended approval of Lymerix, the panel's chairwoman, Dr. Patricia
L. Ferrieri of the University of Minnesota Medical School, said it had
taken the action with unusual "ambivalence" because of concerns about
the possibility of severe reactions.

Autoimmune Reaction

Dr. Allen C. Steere, who directed SmithKline Beecham's trials of the
vaccine, told the committee that it was hypothetically possible that
the vaccine could set off an autoimmune reaction in which the body's
immune system attacks its own tissue, and that this could cause
treatment-resistant arthritis.

In addition, Dr. Steere had expressed the concern as early as 1995,
shortly after the start of the clinical trials, when he said that some
patients were already developing joint pain after getting the vaccine.
"A small percentage of patients have developed joint pain and
arthritis following vaccination," Dr. Steere said in a letter to the
National Institutes of Health.

In July 1998, two months after Dr. Steere recommended the vaccine's
approval, he and colleagues reported in the journal Science that they
believed they had found the cause of the adverse effects. They
discovered that a piece of protein on the outer surface of the Lyme
bacteria was strikingly similar, to a natural human protein in blood
and other cells. This raised the theoretical possibility that when an
infected tick bites a human, the person's immune system T-cells, the
soldiers on the front line of the body's defense against disease,
could destroy not only the foreign invader but also some of the body's
own protein.

Legal Action

About 60 patients who believe they were made ill by the Lyme vaccine
are suing SmithKline Beecham for monetary damages, said Stephen A.
Sheller, a lawyer with Sheller, Ludwig & Badey, of Philadelphia, which
is handling the suits. And class-action suits have been filed by the
firm in New York, New Jersey and Pennsylvania seeking to require the
company to warn doctors and patients that it poses possible risks for
those who are genetically predisposed to autoimmune arthritis or who
have been previously infected with Lyme bacteria.

To see the complete text of the Lymerix complaint filed against
SmithKline Beecham go to http://www.sheller.com/complaint.htm.

New York Times November 21, 2000


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