Post by questionhair on Apr 11, 2007 15:45:01 GMT -5
about Lyme vaccinations:
=====================================================================
www.lymediseaseassociation.org/ConflictReport.pdf
This is a large pdf file (182 pages). . . here are some excerpts
from
CONFLICTS OF INTEREST IN LYME DISEASE:
LABORATORY TESTING, VACCINATION, AND TREATMENT GUIDELINES
" . . . scientists decided to marshal the dynamics of transition to
build their vaccine. The idea: Inoculate humans with antibody to
OspA. Then, when the tick takes its human blood meal, anti-OspA
will rush from its mouth to its gut, killing Borrelia burgdorferi
beforeit can make the journey back down the pathway to infect the
human host.
As elegant as the concept was, its flaws remained a concern.
Through the 1990s for instance, an increasing amount of peer-
reviewed literature showed that OspA was expressed in humans, after
all -- just a bit in some in the first months of illness, but with
increasing intensity as infection disseminated and matured. Other
studies showed that in individuals positive for the particular gene,
HLA-DR4 -- some 30 percent of the population -- there was increased
risk for an especially chronic form of Lyme arthritis found to be
refractory to antibiotics . . ."
" LDA COMMENT We'd like to excerpt a story from the June 14,
2000 issue of the (Newark) Star-Ledger, where reporter Edward R.
Silverman wrote:
"In October 1998, patients participating in a clinical trial for the
forthcoming Lyme disease vaccine were asked to sign papers
indicating a "theoretical possibility" existed that the vaccine
might cause arthritis in certain genetically susceptible
individuals, according to documents obtained by The Star-Ledger.
By January 1999, however, the Lymerix vaccine was approved by the
Food and Drug Administration and the manufacturer, SmithKline
Beecham plc, began marketing it. But the product labeling, or
prescribing information, didn't mention the possibility that Lymerix
may cause arthritis in people with a particular genetic profile.
Since then, dozens of people are claiming they developed severe
arthritis-like symptoms after being vaccinated and, subsequently,
some tested positive for the particular gene, HLA-DR4. This gene,
which up to 30 percent of the population is believed to have, is the
same one that has been linked, at least theoretically, to arthritis
symptoms. . . ."
"Vanessa Raffio was a horsewoman and a veterinarian's helper who
loved hiking and riding in the woods - hobbies that seemed to place
the suburban New Jersey teenager at high risk for getting Lyme
disease. So two years ago, Raffio, then 17, asked her doctor for
the recently approved vaccine against the tick-borne infection.
"I'm the one who pushed for it," recalled her mother, Linda Sharf-
Lurie. "It was the biggest mistake of my life."
Soon after she got her second dose of the vaccine in June 1999,
Raffio began having pains in her ankles, she said. That autumn, she
developed severe pain in her neck and back as well, and was
eventually diagnosed with rheumatoid arthritis. She also
permanently lost the peripheral vision in her left eye when her
optic nerve became inflamed.
These days, Raffio, now a college freshman at the University of
Missouri at Columbia, is able to ride her horse only for brief
periods, and uses an electrical nerve stimulator to relieve her
chronic pain . . ."
" . . . Arthritis and neurological disorders are among the medical
problems that have been reported to the FDA by some recipients of
LYMErix, but there is no clear pattern to suggest the vaccine was
the cause, said Robert Ball, the agency's acting chief of vaccine
safety. However, he cautioned, "the way we receive [reports],
it's usually difficult or impossible to determine if a vaccine is
causing adverse events" without doing additional studies. . ."
" . . . It's unpleasant to think that physicians and scientists
entrusted with the public good would redefine the parameters of a
disease to enable approval and marketing of the products on which
their patents and entrepreneurial ventures are based. But a review
of the patent list below suggests the appearance of this possibility
in Lyme. It turns out that many of those who hold rights to the
patents, either directly or through investment, license, or
marketing agreement, are the same individuals and organizations who
sit on official committees that determine the fate of those
patents. They do so by their ability to determine diagnostic
criteria, standard of care, and -- in some situations -- approval of
the patent itself. The devil is in the details. In that spirit,
we present the patents defining the Lyme disease product roll-out,
below . . .
(end of quoted excerpts from the 182 page pdf file.)
This large pdf file makes for interesting reading . . . it tells
about the people who made the decisions bringing the lyme vaccine
to market - and it reveals the lineup of profitable laboratory
diagnostic tests that were to follow - and the conflict of interest
by many parties
involved.
Many people with Lyme disease have suffered undiagnosed
and untreated due to these business-based decisions . . . decisions
that tweaked diagnostic guidelines in order to bring certain
products to market. Some of the people with conflicts of interest
worked for the approving governmental agencies - like the CDC.
================================
www.canlyme.com/lymerix.html
The Bitter Feud over LYMErix - Big Pharma Takes on the Wrong Little
Osp
by Pamela Weintraub
" . . . Paul Fawcett, director of the immunology laboratories at the
duPont Hospital for Children in Wilmington, Delaware, and a noted
expert on Lyme disease serology, says he'd observed the ability of
the OspA vaccine to provoke a wide range of Borrelia-specific bands
on Western blots well before the product reached market, as patients
involved in clinical trials appeared for routine Lyme disease tests.
Fascinated by the phenomenon, he coordinated a study of 20 adult
volunteers, all employees of the hospital, who received three
vaccine doses each and submitted blood for analysis. . .
. . . What could be going on? Describing himself as a "fan of data,"
Fawcett reviewed his findings and concluded the only explanation was
a "hyperactivation" of the immune system after exposure to the
vaccine. "This test group was clean," he says of his adult
trial, "with absolutely no serological evidence of prior exposure to
B. burgdorferi at baseline. . ."
============================================================
www.lyme.org/vaccine/3yrsrteslong.html
Testimony to the FDA:
"I am Karen Vanderhoof-Forschner, a mother whose child was born
with, handicapped by, and died from Lyme disease. . . .
. . . I have always appreciated the value of how vaccines help
prevent terrible illnesses. My son had received his childhood
vaccines, and my daughter is current in her vaccinations. My great-
aunt had lifelong crippling effects from polio, so I am grateful a
polio vaccine was available for my generation. I take the flu
vaccine every year. My pets (dogs, cats, horse) have always been
fully vaccinated. . . .
. . . The Lyme vaccine trial and approval process have been
seriously flawed, vital information has been withheld from the
Vaccine Advisory Committee and the FDA, and experts who could have
helped provide critical analysis were never invited to
participate ... enough to compromise all trial data and cast doubts
on the integrity of all involved. . . "
======================================================
www.canlyme.com/cdc_implicated_2006.html
CDC Lyme Researchers Implicated
" . . . Currently the CDC oversees vaccine research, safety and
promotion, a situation that has been drawing more and more public
criticism in recent years. The CDC compiles the list of vaccines
that doctors are to give all children in the US, based on the
recommendations of an advisory panel, and in many states kids can
not attend day care or public schools unless they have received the
CDC-endorsed vaccines.
A recommendation by the CDC guarantees a huge market for a vaccine
and enables the drug company to use the government as a marketing
device for its product. The annual global market for vaccines is
expected to be over $10 billion this year.
On July 21, 2003, United Press International published a report
based on a four-month investigation that found a pattern of problems
linked to vaccines recommended by the CDC, as well as a web of close
ties between the agency's advisory panel and the pharmaceutical
industry.
By investigating members of an advisory panel of outside experts
that make vaccine recommendations, UPI found that members of the
panel received money from vaccine makers through relationships that
included: sharing a vaccine patent; owning stock in a vaccine
company; payments for research; money to monitor vaccine testing;
and funding for academic departments. . . ."
=====================================================================
www.lymediseaseassociation.org/ConflictReport.pdf
This is a large pdf file (182 pages). . . here are some excerpts
from
CONFLICTS OF INTEREST IN LYME DISEASE:
LABORATORY TESTING, VACCINATION, AND TREATMENT GUIDELINES
" . . . scientists decided to marshal the dynamics of transition to
build their vaccine. The idea: Inoculate humans with antibody to
OspA. Then, when the tick takes its human blood meal, anti-OspA
will rush from its mouth to its gut, killing Borrelia burgdorferi
beforeit can make the journey back down the pathway to infect the
human host.
As elegant as the concept was, its flaws remained a concern.
Through the 1990s for instance, an increasing amount of peer-
reviewed literature showed that OspA was expressed in humans, after
all -- just a bit in some in the first months of illness, but with
increasing intensity as infection disseminated and matured. Other
studies showed that in individuals positive for the particular gene,
HLA-DR4 -- some 30 percent of the population -- there was increased
risk for an especially chronic form of Lyme arthritis found to be
refractory to antibiotics . . ."
" LDA COMMENT We'd like to excerpt a story from the June 14,
2000 issue of the (Newark) Star-Ledger, where reporter Edward R.
Silverman wrote:
"In October 1998, patients participating in a clinical trial for the
forthcoming Lyme disease vaccine were asked to sign papers
indicating a "theoretical possibility" existed that the vaccine
might cause arthritis in certain genetically susceptible
individuals, according to documents obtained by The Star-Ledger.
By January 1999, however, the Lymerix vaccine was approved by the
Food and Drug Administration and the manufacturer, SmithKline
Beecham plc, began marketing it. But the product labeling, or
prescribing information, didn't mention the possibility that Lymerix
may cause arthritis in people with a particular genetic profile.
Since then, dozens of people are claiming they developed severe
arthritis-like symptoms after being vaccinated and, subsequently,
some tested positive for the particular gene, HLA-DR4. This gene,
which up to 30 percent of the population is believed to have, is the
same one that has been linked, at least theoretically, to arthritis
symptoms. . . ."
"Vanessa Raffio was a horsewoman and a veterinarian's helper who
loved hiking and riding in the woods - hobbies that seemed to place
the suburban New Jersey teenager at high risk for getting Lyme
disease. So two years ago, Raffio, then 17, asked her doctor for
the recently approved vaccine against the tick-borne infection.
"I'm the one who pushed for it," recalled her mother, Linda Sharf-
Lurie. "It was the biggest mistake of my life."
Soon after she got her second dose of the vaccine in June 1999,
Raffio began having pains in her ankles, she said. That autumn, she
developed severe pain in her neck and back as well, and was
eventually diagnosed with rheumatoid arthritis. She also
permanently lost the peripheral vision in her left eye when her
optic nerve became inflamed.
These days, Raffio, now a college freshman at the University of
Missouri at Columbia, is able to ride her horse only for brief
periods, and uses an electrical nerve stimulator to relieve her
chronic pain . . ."
" . . . Arthritis and neurological disorders are among the medical
problems that have been reported to the FDA by some recipients of
LYMErix, but there is no clear pattern to suggest the vaccine was
the cause, said Robert Ball, the agency's acting chief of vaccine
safety. However, he cautioned, "the way we receive [reports],
it's usually difficult or impossible to determine if a vaccine is
causing adverse events" without doing additional studies. . ."
" . . . It's unpleasant to think that physicians and scientists
entrusted with the public good would redefine the parameters of a
disease to enable approval and marketing of the products on which
their patents and entrepreneurial ventures are based. But a review
of the patent list below suggests the appearance of this possibility
in Lyme. It turns out that many of those who hold rights to the
patents, either directly or through investment, license, or
marketing agreement, are the same individuals and organizations who
sit on official committees that determine the fate of those
patents. They do so by their ability to determine diagnostic
criteria, standard of care, and -- in some situations -- approval of
the patent itself. The devil is in the details. In that spirit,
we present the patents defining the Lyme disease product roll-out,
below . . .
(end of quoted excerpts from the 182 page pdf file.)
This large pdf file makes for interesting reading . . . it tells
about the people who made the decisions bringing the lyme vaccine
to market - and it reveals the lineup of profitable laboratory
diagnostic tests that were to follow - and the conflict of interest
by many parties
involved.
Many people with Lyme disease have suffered undiagnosed
and untreated due to these business-based decisions . . . decisions
that tweaked diagnostic guidelines in order to bring certain
products to market. Some of the people with conflicts of interest
worked for the approving governmental agencies - like the CDC.
================================
www.canlyme.com/lymerix.html
The Bitter Feud over LYMErix - Big Pharma Takes on the Wrong Little
Osp
by Pamela Weintraub
" . . . Paul Fawcett, director of the immunology laboratories at the
duPont Hospital for Children in Wilmington, Delaware, and a noted
expert on Lyme disease serology, says he'd observed the ability of
the OspA vaccine to provoke a wide range of Borrelia-specific bands
on Western blots well before the product reached market, as patients
involved in clinical trials appeared for routine Lyme disease tests.
Fascinated by the phenomenon, he coordinated a study of 20 adult
volunteers, all employees of the hospital, who received three
vaccine doses each and submitted blood for analysis. . .
. . . What could be going on? Describing himself as a "fan of data,"
Fawcett reviewed his findings and concluded the only explanation was
a "hyperactivation" of the immune system after exposure to the
vaccine. "This test group was clean," he says of his adult
trial, "with absolutely no serological evidence of prior exposure to
B. burgdorferi at baseline. . ."
============================================================
www.lyme.org/vaccine/3yrsrteslong.html
Testimony to the FDA:
"I am Karen Vanderhoof-Forschner, a mother whose child was born
with, handicapped by, and died from Lyme disease. . . .
. . . I have always appreciated the value of how vaccines help
prevent terrible illnesses. My son had received his childhood
vaccines, and my daughter is current in her vaccinations. My great-
aunt had lifelong crippling effects from polio, so I am grateful a
polio vaccine was available for my generation. I take the flu
vaccine every year. My pets (dogs, cats, horse) have always been
fully vaccinated. . . .
. . . The Lyme vaccine trial and approval process have been
seriously flawed, vital information has been withheld from the
Vaccine Advisory Committee and the FDA, and experts who could have
helped provide critical analysis were never invited to
participate ... enough to compromise all trial data and cast doubts
on the integrity of all involved. . . "
======================================================
www.canlyme.com/cdc_implicated_2006.html
CDC Lyme Researchers Implicated
" . . . Currently the CDC oversees vaccine research, safety and
promotion, a situation that has been drawing more and more public
criticism in recent years. The CDC compiles the list of vaccines
that doctors are to give all children in the US, based on the
recommendations of an advisory panel, and in many states kids can
not attend day care or public schools unless they have received the
CDC-endorsed vaccines.
A recommendation by the CDC guarantees a huge market for a vaccine
and enables the drug company to use the government as a marketing
device for its product. The annual global market for vaccines is
expected to be over $10 billion this year.
On July 21, 2003, United Press International published a report
based on a four-month investigation that found a pattern of problems
linked to vaccines recommended by the CDC, as well as a web of close
ties between the agency's advisory panel and the pharmaceutical
industry.
By investigating members of an advisory panel of outside experts
that make vaccine recommendations, UPI found that members of the
panel received money from vaccine makers through relationships that
included: sharing a vaccine patent; owning stock in a vaccine
company; payments for research; money to monitor vaccine testing;
and funding for academic departments. . . ."