Re: Vaccine taken off the mkt. because of poor sales-HUH?On May 26, 5:32=EF=BF=BDpm, Mort Zuckerman <morph...@yahoo,com > wrote:
> On May 26, 4:15 pm, chronichel...@yahoo,com wrote:
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> > On May 26, 11:55 am, lipanz <lipanzmari...@aol,com > wrote:
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> > > 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.
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> > > Physician Opposition
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> > > 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.
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> > > 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
>
> > That's interesting, I'm more interested in that angle of the
> > controversy. First and foremost, I can't believe any Dr. would even
> > think that the vaccine could actually cause Lyme. The obvious reason
> > is that the vaccine is developed with a protein of the bacteria,
> > meaning a piece of it, so its impossible to get infected with Lyme
> > through this vaccine. This sort of arguments with no basis is what
> > makes many scientists, Dr, etc to roll their eyes and dismiss possible
> > relevant information.
>
> > Steere talks about a possible autoimmune response, and I'm sure he
> > suspects a lot of people did develop Lyme like syndrome due to the
> > vaccine. Ironically, that will go in turn to validate the hypothesis
> > that people will develop severe illness even after the infection has
> > been cleared up, and hence long term use of antibiotics has very
> > little therapeutic. Hopefully this will result in more research put
> > into understanding this phenomenon.
>
> http :// www .actionlyme.org/SCHOEN_INSTRUCTING_DOCS_TO_BLOW_OFF_LYMERIX...- =
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Brian Fallon studied for nearly 10 years with a 5 million dollar NIH
grant... (This will eventually be charged as a mass murder crime.)
Good post K. Oh now I see where Fallon got his grant money from the
crooked FDA....Wonder how he swung that. Like I said before I always
suspected in the beginning of when this study started he was going to
be a turncoat. .Now I understand the outcome of his study......Your
absolutely right.