Fight Over Vaccine-Autism Link Hits Court

http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06

For more than a decade, families across the country have been warring with
the medical establishment over their claims that routine childhood vaccines
are responsible for the nation's apparent epidemic of autism. In an
extraordinary proceeding that begins tomorrow, the battle will move from the
ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in
Washington that the vaccines can cause healthy and outgoing children to
withdraw into uncommunicative, autistic shells -- even though a large body
of evidence and expert opinion has found no link. The court has never heard
a case of such magnitude.

The shift from laboratory to courtroom means the outcome will hinge not on
scientific standards of evidence but on a legal standard of plausibility --
what one lawyer for the families called "50 percent and a feather." That may
make it easier for the plaintiffs to sway the panel of three "special
masters," which is why the decision could not only change the lives of
thousands of American families but also have a profound effect on the
decisions of parents around the world about whether to vaccinate their
children.

A victory by the plaintiffs, public health officials say, could increase the
number of children who are not given vaccines and fall sick or die from the
diseases they prevent.

Economics and politics intersect in the case with questions of health and
the deepening mystery of soaring autism rates. Advocates of the vaccine
theory have argued that the increase in cases was triggered by a
mercury-based preservative in vaccines that, they say, is toxic to
children's brains.

Under pressure from the advocates and to keep the issue from disrupting
vaccination programs, U.S. officials began phasing out the additive,
thimerosal, in children's vaccines around 1999 while maintaining that there
was no hard evidence that it was dangerous. But thimerosal is still used in
vaccines across much of the developing world. If the vaccine court decides
that the preservative caused autism, parents of children in poor countries
are likely to protest its inclusion, but removing it would make vaccines
much more expensive and potentially put them out of reach for many.

Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims,
where the case is to be heard, said he is aware of the larger ramifications.
But the court's job, he said, is only to focus on whether plaintiffs show a
plausible link between vaccines and autism.

About 20 experts are expected to testify in the case, which will involve a
staggering amount of complicated epidemiology and biochemistry. Golkiewicz
said a ruling could be a year off.

Experts for the government will argue that a range of epidemiological
studies found no link between vaccines and autism, as the prestigious
Institute of Medicine concluded in a 2004 report. The institute, part of the
National Academies that was chartered by Congress to advise the government
and the public on matters of science, dismissed the vaccine-autism theory,
which is mostly based on biochemistry studies on the toxic effects of
mercury.

Large international studies -- and preliminary evidence from the United
States -- suggest that after thimerosal was removed from children's
vaccines, autism rates continued to soar.

If thimerosal was the cause, removing it should have sharply lowered autism
rates, scientists say. Although definitive national evidence is not in --
children vaccinated after 1999 are just beginning to enter school, which is
the point at which many receive a diagnosis -- data from California suggest
that autism rates are continuing to climb steeply.

The cases are rising, experts say, primarily because of better diagnosis and
services: Parents and teachers are more attuned to the signs of autism, and
doctors are better equipped to spot it than they were two decades ago. Also,
the boundaries of the diagnosis have expanded to include a range of problems
under an umbrella known as autism spectrum disorders.

The plaintiffs acknowledge that their case is far from airtight
scientifically. But Kevin Conway, a Boston attorney representing the family
of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated
the opening test case for more than 4,800 plaintiffs, said that even if the
science is equivocal, he has a good legal argument, which is all he needs.

"There is a difference between scientific proof and legal proof," Conway
said. "One is 95 percent certainty, and the other is . . . 50 percent and a
feather."

Besides, Conway added, those who support the vaccine-autism theory did not
put all their eggs in the thimerosal basket. They are also arguing that
something else in vaccines might be making children sick.

Like many other advocates of the link, Conway said he believes that vaccines
in general are a good thing and have saved many lives. In an age of
bioterrorism, moreover, vaccines are not just a health priority but a
national security priority. But Congress's efforts to shield vaccine makers
from lawsuits over the rare but inevitable side effects of vaccines have
given the companies no incentive to make vaccines as safe as possible,
Conway said.

Congress set up the vaccine court to provide compensation for individuals
harmed by those side effects, because lawsuits were threatening to put
vaccine makers out of business.

The law requires people claiming they were harmed by a vaccine to bring the
case in the special court first, but if they lose, they can still file suit
in civil courts.

Scientific advocates for the vaccine-autism theory, such as the
father-and-son team of Mark and David Geier of Silver Spring, say fears
about damaging public health programs have prompted scientists and the
government to hide evidence of a problem. Many of the families believe that
the medical establishment and the U.S. Centers for Disease Control and
Prevention have conspired in a massive coverup.

Peter Hotez, president of the Sabin Vaccine Institute and a biology
professor at George Washington University, who has a 14-year-old autistic
daughter, said the controversy has distracted from the real problem: finding
services for rising numbers of autistic children and ramping up research to
find a cure.

"We are absolutely confident Rachel's vaccines have nothing to do with her
autism," he said. "If we could roll back the clock, we would give her all
the vaccines again."

But the family of severely autistic Michelle Cedillo, who arrived in
Washington on Friday for the trial, disagrees.

Michelle was a healthy 15-month-old when she was given the
measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so
words she had been able to speak -- including Mommy, Daddy, baby, kitty and
juice -- vanished. She developed a high fever one week after the shot and
went rapidly downhill. Today, she does not speak and is totally dependent on
caregivers. She suffers from seizures, arthritis and inflammatory bowel
disease and is nearly blind.

Cedillo said she is "not anti-vaccine" and not very interested in playing
the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We
want to focus on Michelle and find out what happened and get the help for
her that she needs."

JOHN wrote:
http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

Isn't that sad!

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The DOJ attorneys are doing an excellent job of preparing for the trials.


By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06

For more than a decade, families across the country have been warring with
the medical establishment over their claims that routine childhood vaccines
are responsible for the nation's apparent epidemic of autism. In an
extraordinary proceeding that begins tomorrow, the battle will move from the
ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in
Washington that the vaccines can cause healthy and outgoing children to
withdraw into uncommunicative, autistic shells -- even though a large body
of evidence and expert opinion has found no link. The court has never heard
a case of such magnitude.

The shift from laboratory to courtroom means the outcome will hinge not on
scientific standards of evidence but on a legal standard of plausibility --
what one lawyer for the families called "50 percent and a feather." That may
make it easier for the plaintiffs to sway the panel of three "special
masters," which is why the decision could not only change the lives of
thousands of American families but also have a profound effect on the
decisions of parents around the world about whether to vaccinate their
children.

A victory by the plaintiffs, public health officials say, could increase the
number of children who are not given vaccines and fall sick or die from the
diseases they prevent.

Economics and politics intersect in the case with questions of health and
the deepening mystery of soaring autism rates. Advocates of the vaccine
theory have argued that the increase in cases was triggered by a
mercury-based preservative in vaccines that, they say, is toxic to
children's brains.

Under pressure from the advocates and to keep the issue from disrupting
vaccination programs, U.S. officials began phasing out the additive,
thimerosal, in children's vaccines around 1999 while maintaining that there
was no hard evidence that it was dangerous. But thimerosal is still used in
vaccines across much of the developing world. If the vaccine court decides
that the preservative caused autism, parents of children in poor countries
are likely to protest its inclusion, but removing it would make vaccines
much more expensive and potentially put them out of reach for many.

Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims,
where the case is to be heard, said he is aware of the larger ramifications.
But the court's job, he said, is only to focus on whether plaintiffs show a
plausible link between vaccines and autism.

About 20 experts are expected to testify in the case, which will involve a
staggering amount of complicated epidemiology and biochemistry. Golkiewicz
said a ruling could be a year off.

Experts for the government will argue that a range of epidemiological
studies found no link between vaccines and autism, as the prestigious
Institute of Medicine concluded in a 2004 report. The institute, part of the
National Academies that was chartered by Congress to advise the government
and the public on matters of science, dismissed the vaccine-autism theory,
which is mostly based on biochemistry studies on the toxic effects of
mercury.

Large international studies -- and preliminary evidence from the United
States -- suggest that after thimerosal was removed from children's
vaccines, autism rates continued to soar.

If thimerosal was the cause, removing it should have sharply lowered autism
rates, scientists say. Although definitive national evidence is not in --
children vaccinated after 1999 are just beginning to enter school, which is
the point at which many receive a diagnosis -- data from California suggest
that autism rates are continuing to climb steeply.

The cases are rising, experts say, primarily because of better diagnosis and
services: Parents and teachers are more attuned to the signs of autism, and
doctors are better equipped to spot it than they were two decades ago. Also,
the boundaries of the diagnosis have expanded to include a range of problems
under an umbrella known as autism spectrum disorders.

The plaintiffs acknowledge that their case is far from airtight
scientifically. But Kevin Conway, a Boston attorney representing the family
of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated
the opening test case for more than 4,800 plaintiffs, said that even if the
science is equivocal, he has a good legal argument, which is all he needs.

"There is a difference between scientific proof and legal proof," Conway
said. "One is 95 percent certainty, and the other is . . . 50 percent and a
feather."

Besides, Conway added, those who support the vaccine-autism theory did not
put all their eggs in the thimerosal basket. They are also arguing that
something else in vaccines might be making children sick.

Like many other advocates of the link, Conway said he believes that vaccines
in general are a good thing and have saved many lives. In an age of
bioterrorism, moreover, vaccines are not just a health priority but a
national security priority. But Congress's efforts to shield vaccine makers
from lawsuits over the rare but inevitable side effects of vaccines have
given the companies no incentive to make vaccines as safe as possible,
Conway said.

Congress set up the vaccine court to provide compensation for individuals
harmed by those side effects, because lawsuits were threatening to put
vaccine makers out of business.

The law requires people claiming they were harmed by a vaccine to bring the
case in the special court first, but if they lose, they can still file suit
in civil courts.

Scientific advocates for the vaccine-autism theory, such as the
father-and-son team of Mark and David Geier of Silver Spring, say fears
about damaging public health programs have prompted scientists and the
government to hide evidence of a problem. Many of the families believe that
the medical establishment and the U.S. Centers for Disease Control and
Prevention have conspired in a massive coverup.

Peter Hotez, president of the Sabin Vaccine Institute and a biology
professor at George Washington University, who has a 14-year-old autistic
daughter, said the controversy has distracted from the real problem: finding
services for rising numbers of autistic children and ramping up research to
find a cure.

"We are absolutely confident Rachel's vaccines have nothing to do with her
autism," he said. "If we could roll back the clock, we would give her all
the vaccines again."

But the family of severely autistic Michelle Cedillo, who arrived in
Washington on Friday for the trial, disagrees.

Michelle was a healthy 15-month-old when she was given the
measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so
words she had been able to speak -- including Mommy, Daddy, baby, kitty and
juice -- vanished. She developed a high fever one week after the shot and
went rapidly downhill. Today, she does not speak and is totally dependent on
caregivers. She suffers from seizures, arthritis and inflammatory bowel
disease and is nearly blind.

Cedillo said she is "not anti-vaccine" and not very interested in playing
the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We
want to focus on Michelle and find out what happened and get the help for
her that she needs."

In article jk_ai.1543$wL5.1338@trndny04,
Mark Probert wrote:
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

Isn't that sad!

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The DOJ attorneys are doing an excellent job of preparing for the trials.

I hope so. Of course, when the Mercury Militia loses the case,
they'll just howl that it's all part of the Konspiracy and try
even harder. God forbid they ever cotton onto the idea that
they're off-track and would be better advised to try to look for
real solutions.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"Only George Bush could start a war for oil and not get any."
-- Bill Maher

"Mark Probert" wrote in message
news:jk_ai.1543$wL5.1338@trndny04...
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

Isn't that sad!

Yes it is and sadder is the fact that *organized medicine* LIES.

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The Daubert standard protects MERRELL DOW PHARMACEUTICALS, INC.

The DOJ attorneys are doing an excellent job of preparing for the trials.

Leads us back to *trust* the government. Only a fool is unaware.


By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06

For more than a decade, families across the country have been warring
with
the medical establishment over their claims that routine childhood
vaccines
are responsible for the nation's apparent epidemic of autism. In an
extraordinary proceeding that begins tomorrow, the battle will move from
the
ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in
Washington that the vaccines can cause healthy and outgoing children to
withdraw into uncommunicative, autistic shells -- even though a large
body
of evidence and expert opinion has found no link. The court has never
heard
a case of such magnitude.

The shift from laboratory to courtroom means the outcome will hinge not
on
scientific standards of evidence but on a legal standard of
plausibility --
what one lawyer for the families called "50 percent and a feather." That
may
make it easier for the plaintiffs to sway the panel of three "special
masters," which is why the decision could not only change the lives of
thousands of American families but also have a profound effect on the
decisions of parents around the world about whether to vaccinate their
children.

A victory by the plaintiffs, public health officials say, could increase
the
number of children who are not given vaccines and fall sick or die from
the
diseases they prevent.

Economics and politics intersect in the case with questions of health and
the deepening mystery of soaring autism rates. Advocates of the vaccine
theory have argued that the increase in cases was triggered by a
mercury-based preservative in vaccines that, they say, is toxic to
children's brains.

Under pressure from the advocates and to keep the issue from disrupting
vaccination programs, U.S. officials began phasing out the additive,
thimerosal, in children's vaccines around 1999 while maintaining that
there
was no hard evidence that it was dangerous. But thimerosal is still used
in
vaccines across much of the developing world. If the vaccine court
decides
that the preservative caused autism, parents of children in poor
countries
are likely to protest its inclusion, but removing it would make vaccines
much more expensive and potentially put them out of reach for many.

Gary Golkiewicz, chief special master in the U.S. Court of Federal
Claims,
where the case is to be heard, said he is aware of the larger
ramifications.
But the court's job, he said, is only to focus on whether plaintiffs show
a
plausible link between vaccines and autism.

About 20 experts are expected to testify in the case, which will involve
a
staggering amount of complicated epidemiology and biochemistry.
Golkiewicz
said a ruling could be a year off.

Experts for the government will argue that a range of epidemiological
studies found no link between vaccines and autism, as the prestigious
Institute of Medicine concluded in a 2004 report. The institute, part of
the
National Academies that was chartered by Congress to advise the
government
and the public on matters of science, dismissed the vaccine-autism
theory,
which is mostly based on biochemistry studies on the toxic effects of
mercury.

Large international studies -- and preliminary evidence from the United
States -- suggest that after thimerosal was removed from children's
vaccines, autism rates continued to soar.

If thimerosal was the cause, removing it should have sharply lowered
autism
rates, scientists say. Although definitive national evidence is not in --
children vaccinated after 1999 are just beginning to enter school, which
is
the point at which many receive a diagnosis -- data from California
suggest
that autism rates are continuing to climb steeply.

The cases are rising, experts say, primarily because of better diagnosis
and
services: Parents and teachers are more attuned to the signs of autism,
and
doctors are better equipped to spot it than they were two decades ago.
Also,
the boundaries of the diagnosis have expanded to include a range of
problems
under an umbrella known as autism spectrum disorders.

The plaintiffs acknowledge that their case is far from airtight
scientifically. But Kevin Conway, a Boston attorney representing the
family
of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was
designated
the opening test case for more than 4,800 plaintiffs, said that even if
the
science is equivocal, he has a good legal argument, which is all he
needs.

"There is a difference between scientific proof and legal proof," Conway
said. "One is 95 percent certainty, and the other is . . . 50 percent and
a
feather."

Besides, Conway added, those who support the vaccine-autism theory did
not
put all their eggs in the thimerosal basket. They are also arguing that
something else in vaccines might be making children sick.

Like many other advocates of the link, Conway said he believes that
vaccines
in general are a good thing and have saved many lives. In an age of
bioterrorism, moreover, vaccines are not just a health priority but a
national security priority. But Congress's efforts to shield vaccine
makers
from lawsuits over the rare but inevitable side effects of vaccines have
given the companies no incentive to make vaccines as safe as possible,
Conway said.

Congress set up the vaccine court to provide compensation for individuals
harmed by those side effects, because lawsuits were threatening to put
vaccine makers out of business.

The law requires people claiming they were harmed by a vaccine to bring
the
case in the special court first, but if they lose, they can still file
suit
in civil courts.

Scientific advocates for the vaccine-autism theory, such as the
father-and-son team of Mark and David Geier of Silver Spring, say fears
about damaging public health programs have prompted scientists and the
government to hide evidence of a problem. Many of the families believe
that
the medical establishment and the U.S. Centers for Disease Control and
Prevention have conspired in a massive coverup.

Peter Hotez, president of the Sabin Vaccine Institute and a biology
professor at George Washington University, who has a 14-year-old autistic
daughter, said the controversy has distracted from the real problem:
finding
services for rising numbers of autistic children and ramping up research
to
find a cure.

"We are absolutely confident Rachel's vaccines have nothing to do with
her
autism," he said. "If we could roll back the clock, we would give her all
the vaccines again."

But the family of severely autistic Michelle Cedillo, who arrived in
Washington on Friday for the trial, disagrees.

Michelle was a healthy 15-month-old when she was given the
measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so
words she had been able to speak -- including Mommy, Daddy, baby, kitty
and
juice -- vanished. She developed a high fever one week after the shot and
went rapidly downhill. Today, she does not speak and is totally dependent
on
caregivers. She suffers from seizures, arthritis and inflammatory bowel
disease and is nearly blind.

Cedillo said she is "not anti-vaccine" and not very interested in playing
the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We
want to focus on Michelle and find out what happened and get the help for
her that she needs."

http://www.mercola.com/2000/oct/8/bendectin.htm

http://query.nytimes.com/gst/fullpag... 0C0A963948260

http://www.birthdefects.org/Research/bendectin2.htm

Bendectin

How a Commonly Used Drug Caused Birth Defects

PART TWO

by Betty Mekdeci Executive Director Birth Defect Research for Children

The other active ingredient in Bendectin is Decapryn (doxylamine succinate),
an antihistamine which belongs to a group called ethanolamines, the most
potent and highly sedative of the antihistamines. In fact, doxylamine
succinate is marketed as an over-the-counter sleeping aid called Unisom.
(This product carries a warning. "Do not take if pregnant".) It is also an
ingredient of numerous over-the-counter products for colds and coughs
including Nyquil and Vick's Formula 44 Cough Syrup.

Doxylamine is structurally similar to another ethanolamine, Benadryl. Both
of these antihistamines affect the central nervous system and have
anticholinergic properties like Bentyl. There have been reports of patients
having facial dyskinesia, a nervous disorder causing involuntary repetitive
movements of the face and mouth, after short term use of doxylamine and
Benadryl. 29'30'31 In light of new research on the importance of the nervous
system to fetal development, this facial dyskinesia may be an early warning
signal of potential teratogenic problems much as peripheral neuritis was in
thalidomide patients

In fact, Benadryl was associated with an increase in oral clefts in an
epidemiological study published in The Lancet in 1974.32 Comparable
malformations were also noted in the offspring of test animals exposed to
Benadryl in a 1977 study published in the Archives of Pharmacology and
Toxicology.33

An unpublished survey of 50,282 pregnancies in the Collaborative Perinatal
Project showed a statistically significant increase in diaphragmatic defects
in infants whose mothers were exposed to the ethanolamines, doxylamine and
diphenhydramine (Benadryl) during the first three months of pregnancy.34

Research dating back to 1971 (Kahison and Rosengren) has shown that elevated
levels of histamine can be detected in tissue undergoing rapid growth or
repair such as healing wounds or developing embryonic tissue. Inhibition of
histamine arrests fetal development in test animals.

Since ethanolamine antihistamines have both histamine and
cholinergic-blocking action, 35 their use during pregnancy has the potential
to disrupt the levels of these chemicals that are necessary for normal
growth at different stages of fetal development.

In addition to Bentyl and Decapryn, ingredients that interact and have the
potential for serious adverse effects together and individually, Bendectin
also contained pyridoxine, vitamin B-6. Pyridoxine was thought to be
beneficial in alleviating the symptoms of morning sickness although the
evidence on this is scanty.

Bendectin was promoted in nineteen countries as a safe and effective remedy
for morning sickness. Product sales soared. By the late '70's, Bendectin
ranked as the 91st most prescribed drug in the United States. It has been
estimated that over 33 million women worldwide received Bendectin.

Despite the drug's enormous popularity, questions about Bendectin's safety
continued to trickle in to the company and drug regulatory agencies around
the world. The company's standard reply to physicians reporting cases of
malformation was to assure them that no other cases had been reported, or
that such reports were extremely rare. The doctors would also receive copies
of the Bunde and Bowles Study to reassure them about Bendectin's safety.

Some FDA medical officers were not so convinced. After reviewing the safety
data on Bendectin, they asked the company to undertake additional animal
teratology studies. Merrell responded by producing tests of the individual
ingredients, but no new tests of the combination product.

In 1969, Dr Donald Patterson stirred up a new flurry of concern about
Bendectin's safety. He wrote a letter to the Canadian Medical Journal
reporting several cases of limb defects in children whose mothers had taken
Bendectin.36 That same year the German government held hearings on the
safety of Bendectin, but the company was able to convince the authorities
that there was no problem.37

The reports of congenital malformation kept coming in. Over half the cases
involved absent or partially missing limbs. Merrell dismissed this unusual
skewing toward limb defects as an increased tendency to report any limb
malformation after the thalidomide episode.

Then in 1972, the company got a shock. Dr William McBride, who had first
linked thalidomide to limb defects, reported to the authorities that he
thought Bendectin was responsible for the births of three limbless babies in
Sydney. This confidential report somehow leaked to the press and made
headlines in Australia. 38'39'40 Soon Merrell was rushing to put out
brushfires of suspicion about Bendectin's safety in other parts of the world
as well.

On February 5, 1972, a woman in Milan gave birth to a daughter with a
phocomelic arm. This prominent Italian family arranged for a well-known
research institute to test all the medicine the mother had been given during
early pregnancy. As a result of these tests, the family's attorney wrote to
Merrell.

"The test of your product has given such an alarming result . to determine
the necessity of an immediate intervention.the existence of this danger
being clearly certified, it is hardly believable that this product can be
commercialized as a specified treatment for pregnancy nausea." 41

The company responded immediately that their scientists would meet with the
researchers from the Italian institute at any time, any place in the world.
The outcome of that meeting has never been made public. The government of
Japan requested additional studies with Bendectin. Instead of complying with
the request, the company voluntarily withdrew the product from the Japanese
market in 1974. 42

Since 1976, Bendectin has been the subject of continued controversy and
litigation in the United States and abroad. After the first large award to
the plaintiff in a 1983 Bendectin case, Merrell announced that they would no
longer manufacture Bendectin. They cited the increasing costs of litigation
as the motivating factor in the unprecedented move.

What are the facts? Does Bendectin cause birth defects or are the large jury
awards in some Bendectin cases just the result of kind-hearted juries who
feel sorry for deformed children. The proof lies in the evidence presented
to these juries. Four different types of data are required to prove that a
drug is teratogenic. These include:

1) Animal studies

2) In-vitro or cell culture studies

3) Human data, including epidemiological studies

4) Structural activity relationship

The scientific community considers information derived from all four of
these methods when determining whether a drug causes birth defects in the
developing embryo and fetus.

1) Animal studies

All drugs on the market today were first tested for safety in animals.
Different animals have different levels of sensitivity to different drugs.
For instance, humans are 700 times more sensitive to the teratogenic effects
of thalidomide than hamsters. Since a researcher cannot predict beforehand
which test animal may be sensitive to a particular drug, several species of
animals must be tested at varying dose levels.

Animal tests are used to predict the possibility of an adverse reaction in
even one in 10,000 or one in 100,000 people exposed to a drug. It is not
economically feasible to test a drug in 10,000 rats or rabbits, so
researchers test animals at much higher doses of a drug then humans would
ordinarily be exposed to. In this way, they have a better chance of
predicting whether a particular drug may cause cancer, birth defects or
other toxic effects in even a small percentage of human exposures.43

All drugs known to cause birth defects in humans have produced birth defects
in at least one species of rodent. In addition to rats and rabbits,
Bendectin and/or its ingredients has been tested in chickens, mice and four
kinds of monkeys. Independent studies were performed at the National Center
for Toxicological Research. As result of these studies, the National
Toxicological Program now lists Bendectin as a developmental toxicant. 44

Bendectin Animal Teratology Studies

1963 Staples Merrell 3-part Bendectin rabbits Clubbed limbs, sternal
defects. Kinked tail, abnormal head

1966 Merrell doxylamine rabbits Malformations in 40% of litters at highest
dose

1966 Merrell dicyclomine rabbits 67% resorption at highest dose

1975 Merrell dox + B-6 rats Cleft palate, hematoma, dilated kidney, pelvis,
agnatia

1981 McBride dicyclomine chicks Shortened limbs, exencephaly, gastroschisis

1981 McClure doxylamine rhesus monkeys Growth retardation

1982 Roll/Matthiaschk doxylamine rats Wavy ribs, diaphragmatic hernia

1984 McBride doxylamine rabbits Shortened limbs, micropthalmia, urogenital
defects

1984 NCTR doxylamine rats Delayed bone formation-skeleton especially,
metacarpals

1985 Hendricks, doxylamine macaque monkeys, rhesus monkeys, baboon,
Ventricular septal heart defects, one baboon with multiple heart defects and
limb reduction.

1985 McBride-doxylamine marmosets, Bowel and limb malformation

2) In-vitro or cell culture studies

Dr John Hassell from the National institute of Health studied the effect of
doxylamine on chondrogenesis in mouse limb bud cells. Chondrogenesis is the
ability of limb bud cells to differentiate and form cartilage, the precursor
of bone. When doxylamine was applied directly to these cells, it interfered
with the proper growth and differentiation of the mouse limb bud. 45

3) Human data, including epidemiological studies and individual case reports

Epidemiology is the field of medicine which tries to determine the cause(s)
of birth defects, cancer and other diseases by recording and comparing
incidence rates and possible etiological factors in different human
populations. Mathematical formulas have been devised that turn these
comparisons into an estimated risk of certain etiological factors being
associated with specific adverse outcomes.

In recent years, epidemiological studies have been considered one of the
most important tools for assessing a drug's potential to cause birth
defects. This reliance on epidemiology is questionable since scientific
experts have acknowledged that even thalidomide's association with birth
defects could not be clearly demonstrated using these same techniques.

Three factors must be taken into account in evaluating the reliability of an
epidemiology study. One: Who paid for the study? Industry financed studies
tend to agree with the corporate view of the product's safety. Two: How were
the raw data collected? A study is no better than the raw date on which it
is based. If there are discrepancies in any of the data, the outcome of the
entire study may be subject to reinterpretation.

Three: What was the purpose of the study? A study should be specifically
designed to answer a particular question. Reanalysis of old data from
studies designed to answer different questions may not yield valid results.

Despite the difficulties of the epidemiological approach, Bendectin has been
associated with malformations in both government and company sponsored
studies. In some cases, these associations became apparent when experts
reanalyzed the original raw data from the studies.

Bentectin Epidemiological Studies

Bunde/Bowes: Reanalysis of raw data indicates up to 80% risk of BDN exposed
baby having birth defect

CDC: Statistically significant association with aminiotic band limb defects
and encephalocele.

Heinonen: Data consistent for association of BDN with musculoskeletal
defects.

Jick: Data consistent with modest teratogenic effect on limbs, BDN exposure
increases risk of limb defect 120%

Michaelis: 36% increased risk of malformations in BDN exposed babies

Mitchell: 50% increased risk of limb defects in BDN exposed babies

Rothman: Statistically significant association with heart defects

Golding: Statistically significant association with oral clefts

Eskanaiz/Bracken: Statistically significant association with pyloric
stenosis

Smithells: 36% increased risk of malformation in BDN eaposed babies

Bass: 11-fold increase diaphragmatic hernia in BDN exposed babies

Maynard: Increase in diaphragmatic hernia in BDN exposed babies in analysis
of 5 cohort studies

Most human teratogens were not discovered through animal studies or
epidemiology. The disastrous effects of the rubella virus, thalidomide,
anti-convulsive medications and excessive alcohol consumption during
pregnancy were first reported by alert practioners.Physicians noticed a
pattern of malformations occurring in their patients and searched for a
common etiological factor.

Since the early 1960's the pattern of birth defects reported for Bendectin
has been heavily skewed toward limb reduction defects, part or all of a limb
or limbs missing. A review of case reports of malformations in the Bendectin
files at Merrell and the FDA reveal an extraordinarily high percentage
(one-half or more) of the total defects reported are limb defects. A 1972
interdepartment memorandum from Merrell's Research Director, Dr Carl Bunde
comments that in a review of Bendectin reports. "the type of abnormality
reported is weighted very heavily to skeletal types involving the
extremeties." 46

Dr. Alan Kimball Done, former Special Assistant to the Director of the
Bureau of Drugs at the FDA, testified in court that "one cannot find the
same kind of reporting anywhere in the literature or anywhere else of the
kinds of incidence we are talking about. with any drug other than
Bendectin."

Dr. William McBride reported that he was aware of 77 cases of children born
with limb reduction deformities or malformations of the external ear whose
mothers had proof they had taken Bendectin during the first 7 weeks of
pregnancy, the critical time of formation for these structures.47

In 1983, the Association of Birth Defect Children reviewed some 500 cases of
Bendectin associated birth defects reported to the organization. One-half of
these reports were limb defects.

A teratogen which can affect the limbs frequently causes defective
development of the heart as well since these structures are formed at almost
the same time. Thalidomide caused 14 different kinds of heart defects in
addition to phocomelic limbs. Bendectin reports also reveal an excess of
heart defects. In a review of over 3,000 cases of pediatric cardiac defects
at Boston Children's Hospital, as many as 1,000 cases listed a prenatal
exposure to Bendectin. The probability that Bendectin causes heart defects
is increased by the results of monkey studies showing an excess of
ventricular septal defects in Bendectin exposed offspring and birth defects
monitoring data which report that the incidence of ventricular septal
defects nearly tripled from the mid 1970's to 1981, years when sales of
Bendectin were at their highest.

Although most teratogens are identified by a particular pattern of birth
defects, they may also produce malformations of almost any part of the body
depending on the time of exposure and the genetic suseptibility of the
fetus. According to a report in the British Medical Journal in 1973,
thalidomide defects could be single or multiple involving almost any system
in the body; limb defects; defects of the eyes and ears; malformations of
internal organs including the heart, kidneys and gastrointestinal tract. 45

It may be years before the full spectrum of Bendectin related birth defects
is known. To date, studies and clusters of reports show an association
between Bendectin and the following malformations: limb defects, heart
malformations, defects of the eyes and ears, gastrointestinal malformations,
urogenital defects, oral clefts and certain kinds of central nervous system
defects.

4) Structural activity relationship

In the years since thalidomide, researchers have tried to determine how the
drug caused such tragic deformities. In 1971, Dr William McBride was awarded
a $40,000 international prize for his discovery that thalidomide caused
birth defects. He used the award money to set up Foundation 41, a research
institution that studies the first 40 weeks of life in the womb and the
first seven days outside the womb. Much of the research at Foundation 41
focused on investigating how thalidomide produced birth defects.

McBride and his team hypothesized that thalidomide damaged embryonic nerve
cells that are essential for the proper development of the limbs and other
organs. This theory has had support in the medical literature since the turn
of the century. In 1900, Schlesinger, a German researcher, suggested that a
combination of a limb and muscle defects might be caused by an injury to the
nerve supply rather than to the tissues themselves. 49

In 1966, Gordon suggested a neural basis for thalidomide malformations. He
postulated that thalidomide had a toxic effect on initial nerve impulses to
muscles in the organogenetic phase of development. He went on to correlate
birth defects in thalidomide babies with the peripheral nerve damage seen in
adults who took prolonged doses of the drug. 50

McBride's work on nerve injury preceding limb malformations included
research on Bendectin. Both active ingredients of Bendectin, dicyclomine and
doxylamine, have anticholinergic effects which are potentiated when the
drugs are combined. Anti-cholinergic or atropinic drugs block the passage of
nerve impulses through the parasympathetic nerves. In overdosage, these
drugs can cause the same effect as curare, paralysis of muscles and the
respiratory tract.

The effects of anticholinergics on morphogenesis have been studied since the
early 1900's. New data suggest that cholinergic nerves may be involved in
the phenomena of empryonic growth and differentiation particularly of the
muscles and limbs. Atropinic drugs have been shown to block embryonic
development in echinoderms, amphibia, chicks and ducks.51 McBride also
performed more experiments with atropine, hyoscine and dicyclomine in chicks
and rabbits which resulted in abnormal fetal development.52

One ingredient of Bendectin was shown to cause nerve injury in premarketing
tests. In 1951, Crescitelli and Geissman applied the antihistamine
doxylamine succinate to frog nerve fibers. The drug prevented the
transmission of nervous impulses and caused irreparable damage to the nerve
fiber.53 Many researchers believe embryonic cells are highly vulnerable to
the effects of drugs that can block nerve impulse transmission.

Summary

The proof that Bendectin causes birth defects is based on a composite of
evidence taken from animal studies, cell culture studies, human
epidemiology, case reports and studies of the drug's structure and
activities in the body. However, one important question is left unanswered
even by these methods. If Bendectin has the potential to cause birth
defects, why doesn't it cause malformations in every baby whose mother took
the drug? The Merrell Dow Company reminds the public in every press release
that over 33 million women worldwide have taken the drug.

Thalidomide, the most potent human teratogen known, caused birth defects in
approximately 20% of the babies exposed to the drug in early pregnancy. In
animal tests with thalidomide, some of the offspring would have typical limb
malformations while their litter mates would be normal. Although scientists
do not have all the answers yet, the most current research suggests the
following three factors may determine this difference in susceptibility to
teratogens:

1) The fetus exposed to the drug must be susceptible to its harmful effects.
Because of differences in genetic makeup, one baby may be harmed by a drug
while another shows no ill effects. It has been shown in animal tests that
one genetic strain of rodent will be far more susceptible to the teratogenic
effects of the drug than another.54

2) The drug must be taken at the critical time of fetal development. The
baby's organs and skeleton develop during the first 60 days of pregnancy.
This is the time when a drug exposure can cause major structural defects.
Although the most serious birth defects occur during the early part of fetal
development, toxic exposures can have adverse effects on such things as the
child's neurological development throughout the entire nine months of
pregnancy.

3) Some drugs may exert harmful effects only after they have reached the
fetus in sufficient doses. The amount of a drug that can cause a birth
defect may vary. The metabolism of a drug may be affected by a women's
height, weight, general health and nutritional status.

At the present time, scientists do not have the technology to determine
which babies are potentially at risk from any drug or chemical. Many drugs
and chemicals have structural and pharmacological activity similar to the
ingredients of Bendectin and theorectically would have the same potential to
injure the developing fetus. The safest course for a pregnant woman is to
avoid all unnecessary exposure to drugs and chemicals, including smoking and
alcohol, during the entire nine months of pregnancy.

FOOTNOTES

29 Favis, Gregory R., Facial Dyskinesia Related to Antihistamine", New
England Journal of Medicine, 294:730, 1976.

30 Brait, K.A. Zagerman, A.J., Dyskinesias After Antihistamine Use", New
England Journal of Medicine, 296:111,1977.

31 Lavenstein, B.L., Cantor F.K., "Acute Dystonia: An Unusual Reaction to
Diphenhydramine", JAMA 236:291, 1976

32 Saxen, Irma, "Cleft Palate and Maternal Diphenhydramine Intake", Lancet,
March 9, 1974, pp. 407-8.

33 Alia, F.M., Herranz, J.M., "Study on the Teratogenicity of Benadryl in
Rats", Arch de Farmacol y Toxicol 1977. 111:2. 157.

34 Rosa F., "Antihistamine Exposure in 30 Diaphragmatic Defects Among 50,
282 Outcomes in the Collaborative Perinatal Project", FDA memo 3/15/82

35 Patterson, D.C., Letter to the Editor, C Med Assn. Journal,
101:175-61969.

36 Sickness Pill May Cause Deformity", Perth Daily News, April 19, 1972.

37 Westhoff, Justin. Transcript of testimony during proceeding reviewing
Bendectin in West Germany. 10/7/80.

38 "Sickness Pill May Cause Defornity", Perth Daily News, April 19, 1972.

39 "Health Dept. Won't Talk On Limbless Baby Drug", Canberra News, April 19,
1972.

40 "Another Birth Drug Suspect", Sydney Morning Herald, April 19, 1972.

41 Auletta, A.M., letter to Richardson-Merrell, Inc., February 8, 1973.

42 Richardson-Merrell's answer to interrogatory #101, Mekdeci vs.
Richardson-Merrell, 1977.

43 Epstein, S.S., transcript of presentation on risk assessment for
environmental hazards, Case Western Reserve U. Med. School, p. 218

44 Schwetz, B.A., "Chemicals identified as Reproductive and Developmental
Toxicants", memo to Director NIEHS, Dept. HHS, February 19, 1987, p.2..

45 Hassell, J., Horigan E., "Chondrogenesis: A Model Developmental System
for Measuring Teratogenic Potential of Compounds", Laboratory of
Developmental Biology and Anomalies, National Institute of Dental Research,
NIH.

46 Bunde, C., Interdepartment memo, Richardson-Merrell, 1972.

47 McBride, W.G., Affadavit to federal court, Mekdeci vs.
Richardson-Merrell, July 1980.

48 Smithellis, R.W., "Defects and Disabilities of Thalidomide Children",
British Medical Journal, Feb 3, 1973, pp. 269-272.

49 Schlesinger, H., "ZurLehre vom Angeborenen Pectoralis-Rippendefect und
dem Hoch Stande der Scapula", Wienen Klinische Wochenschrift, 13:25-31,
1900.

50 Gordon, G., Develop. Med. Child Neurol. 8:761-767, 1966.

51 Karczmar, A.G., Srinivasan, R., Bennsohn, J., Cholinergic Function in the
Devoloping Fetus", Fetal Pharmacology, Raven Press, New York 1973, pp.
127-162

52 McBride, W.G. "The Effects of Anticholinergic Drugs on the Development of
the Chick Embryo", IRCS Medical Science, 8, 537, 1980.

53 Crescitelli, F., Geisman, T.A., "Certain Effects of Antihistamines and
Related Compounds on Frog Nerve Fibers", Amer. J. Physiol., 164:509-19.

54 Saxen, L., Rapola, J., "Congenital Defects", Holt, Rinehart and Winston,
New York, 1969, pp. 46-57. Dr" .

"Mark Probert" wrote in message
news:jk_ai.1543$wL5.1338@trndny04...
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

Isn't that sad!

Yes and even sadder is the fact *organized medicine* LIES.

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

Daubert protects the drug companies.

The DOJ attorneys are doing an excellent job of preparing for the trials.

Leads us back to *trust* the government!

http://straylight.law.cornell.edu/su...92-102.ZS.html

No. 92-102. Argued March 30, 1993 -- Decided June 28, 1993


Petitioners, two minor children and their parents, alleged in their suit
against respondent that the children's serious birth defects had been caused
by the mothers' prenatal ingestion of Bendectin, a prescription drug
marketed by respondent. The District Court granted respondent summary
judgment based on a well credentialed expert's affidavit concluding, upon
reviewing the extensive published scientific literature on the subject, that
maternal use of Bendectin has not been shown to be a risk factor for human
birth defects. Although petitioners had responded with the testimony of
eight other well credentialed experts, who based their conclusion that
Bendectin can cause birth defects on animal studies, chemical structure
analyses, and the unpublished "reanalysis" of previously published human
statistical studies, the court determined that this evidence did not meet
the applicable "general acceptance" standard for the admission of expert
testimony.

Note the words *general acceptance standard*.

Set by none other than LYING *organized medicine*!

http://straylight.law.cornell.edu/su...92-102.ZS.html

No. 92-102. Argued March 30, 1993 -- Decided June 28, 1993


Petitioners, two minor children and their parents, alleged in their suit
against respondent that the children's serious birth defects had been caused
by the mothers' prenatal ingestion of Bendectin, a prescription drug
marketed by respondent. The District Court granted respondent summary
judgment based on a well credentialed expert's affidavit concluding, upon
reviewing the extensive published scientific literature on the subject, that
maternal use of Bendectin has not been shown to be a risk factor for human
birth defects. Although petitioners had responded with the testimony of
eight other well credentialed experts, who based their conclusion that
Bendectin can cause birth defects on animal studies, chemical structure
analyses, and the unpublished "reanalysis" of previously published human
statistical studies, the court determined that this evidence did not meet
the applicable "general acceptance" standard for the admission of expert
testimony.

Right up Mark S (disbarred and dishonest) Probert's alley.

Isn't that sad!


By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06

For more than a decade, families across the country have been warring
with
the medical establishment over their claims that routine childhood
vaccines
are responsible for the nation's apparent epidemic of autism. In an
extraordinary proceeding that begins tomorrow, the battle will move from
the
ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in
Washington that the vaccines can cause healthy and outgoing children to
withdraw into uncommunicative, autistic shells -- even though a large
body
of evidence and expert opinion has found no link. The court has never
heard
a case of such magnitude.

The shift from laboratory to courtroom means the outcome will hinge not
on
scientific standards of evidence but on a legal standard of
plausibility --
what one lawyer for the families called "50 percent and a feather." That
may
make it easier for the plaintiffs to sway the panel of three "special
masters," which is why the decision could not only change the lives of
thousands of American families but also have a profound effect on the
decisions of parents around the world about whether to vaccinate their
children.

A victory by the plaintiffs, public health officials say, could increase
the
number of children who are not given vaccines and fall sick or die from
the
diseases they prevent.

Economics and politics intersect in the case with questions of health and
the deepening mystery of soaring autism rates. Advocates of the vaccine
theory have argued that the increase in cases was triggered by a
mercury-based preservative in vaccines that, they say, is toxic to
children's brains.

Under pressure from the advocates and to keep the issue from disrupting
vaccination programs, U.S. officials began phasing out the additive,
thimerosal, in children's vaccines around 1999 while maintaining that
there
was no hard evidence that it was dangerous. But thimerosal is still used
in
vaccines across much of the developing world. If the vaccine court
decides
that the preservative caused autism, parents of children in poor
countries
are likely to protest its inclusion, but removing it would make vaccines
much more expensive and potentially put them out of reach for many.

Gary Golkiewicz, chief special master in the U.S. Court of Federal
Claims,
where the case is to be heard, said he is aware of the larger
ramifications.
But the court's job, he said, is only to focus on whether plaintiffs show
a
plausible link between vaccines and autism.

About 20 experts are expected to testify in the case, which will involve
a
staggering amount of complicated epidemiology and biochemistry.
Golkiewicz
said a ruling could be a year off.

Experts for the government will argue that a range of epidemiological
studies found no link between vaccines and autism, as the prestigious
Institute of Medicine concluded in a 2004 report. The institute, part of
the
National Academies that was chartered by Congress to advise the
government
and the public on matters of science, dismissed the vaccine-autism
theory,
which is mostly based on biochemistry studies on the toxic effects of
mercury.

Large international studies -- and preliminary evidence from the United
States -- suggest that after thimerosal was removed from children's
vaccines, autism rates continued to soar.

If thimerosal was the cause, removing it should have sharply lowered
autism
rates, scientists say. Although definitive national evidence is not in --
children vaccinated after 1999 are just beginning to enter school, which
is
the point at which many receive a diagnosis -- data from California
suggest
that autism rates are continuing to climb steeply.

The cases are rising, experts say, primarily because of better diagnosis
and
services: Parents and teachers are more attuned to the signs of autism,
and
doctors are better equipped to spot it than they were two decades ago.
Also,
the boundaries of the diagnosis have expanded to include a range of
problems
under an umbrella known as autism spectrum disorders.

The plaintiffs acknowledge that their case is far from airtight
scientifically. But Kevin Conway, a Boston attorney representing the
family
of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was
designated
the opening test case for more than 4,800 plaintiffs, said that even if
the
science is equivocal, he has a good legal argument, which is all he
needs.

"There is a difference between scientific proof and legal proof," Conway
said. "One is 95 percent certainty, and the other is . . . 50 percent and
a
feather."

Besides, Conway added, those who support the vaccine-autism theory did
not
put all their eggs in the thimerosal basket. They are also arguing that
something else in vaccines might be making children sick.

Like many other advocates of the link, Conway said he believes that
vaccines
in general are a good thing and have saved many lives. In an age of
bioterrorism, moreover, vaccines are not just a health priority but a
national security priority. But Congress's efforts to shield vaccine
makers
from lawsuits over the rare but inevitable side effects of vaccines have
given the companies no incentive to make vaccines as safe as possible,
Conway said.

Congress set up the vaccine court to provide compensation for individuals
harmed by those side effects, because lawsuits were threatening to put
vaccine makers out of business.

The law requires people claiming they were harmed by a vaccine to bring
the
case in the special court first, but if they lose, they can still file
suit
in civil courts.

Scientific advocates for the vaccine-autism theory, such as the
father-and-son team of Mark and David Geier of Silver Spring, say fears
about damaging public health programs have prompted scientists and the
government to hide evidence of a problem. Many of the families believe
that
the medical establishment and the U.S. Centers for Disease Control and
Prevention have conspired in a massive coverup.

Peter Hotez, president of the Sabin Vaccine Institute and a biology
professor at George Washington University, who has a 14-year-old autistic
daughter, said the controversy has distracted from the real problem:
finding
services for rising numbers of autistic children and ramping up research
to
find a cure.

"We are absolutely confident Rachel's vaccines have nothing to do with
her
autism," he said. "If we could roll back the clock, we would give her all
the vaccines again."

But the family of severely autistic Michelle Cedillo, who arrived in
Washington on Friday for the trial, disagrees.

Michelle was a healthy 15-month-old when she was given the
measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so
words she had been able to speak -- including Mommy, Daddy, baby, kitty
and
juice -- vanished. She developed a high fever one week after the shot and
went rapidly downhill. Today, she does not speak and is totally dependent
on
caregivers. She suffers from seizures, arthritis and inflammatory bowel
disease and is nearly blind.

Cedillo said she is "not anti-vaccine" and not very interested in playing
the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We
want to focus on Michelle and find out what happened and get the help for
her that she needs."

"David Wright" wrote in message
et...
In article jk_ai.1543$wL5.1338@trndny04,
Mark Probert wrote:
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

Isn't that sad!

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The DOJ attorneys are doing an excellent job of preparing for the trials.

I hope so. Of course, when the Mercury Militia loses the case,
they'll just howl that it's all part of the Konspiracy and try
even harder. God forbid they ever cotton onto the idea that
they're off-track and would be better advised to try to look for
real solutions.

There you have it an excellent example of the *gang*. Concerning about
nothing but being right.

Never mind the kids born with birth defects!

Bendectin

How a Commonly Used Drug Caused Birth Defects

PART TWO

by Betty Mekdeci Executive Director Birth Defect Research for Children

The other active ingredient in Bendectin is Decapryn (doxylamine succinate),
an antihistamine which belongs to a group called ethanolamines, the most
potent and highly sedative of the antihistamines. In fact, doxylamine
succinate is marketed as an over-the-counter sleeping aid called Unisom.
(This product carries a warning. "Do not take if pregnant".) It is also an
ingredient of numerous over-the-counter products for colds and coughs
including Nyquil and Vick's Formula 44 Cough Syrup.

Doxylamine is structurally similar to another ethanolamine, Benadryl. Both
of these antihistamines affect the central nervous system and have
anticholinergic properties like Bentyl. There have been reports of patients
having facial dyskinesia, a nervous disorder causing involuntary repetitive
movements of the face and mouth, after short term use of doxylamine and
Benadryl. 29'30'31 In light of new research on the importance of the nervous
system to fetal development, this facial dyskinesia may be an early warning
signal of potential teratogenic problems much as peripheral neuritis was in
thalidomide patients

In fact, Benadryl was associated with an increase in oral clefts in an
epidemiological study published in The Lancet in 1974.32 Comparable
malformations were also noted in the offspring of test animals exposed to
Benadryl in a 1977 study published in the Archives of Pharmacology and
Toxicology.33

An unpublished survey of 50,282 pregnancies in the Collaborative Perinatal
Project showed a statistically significant increase in diaphragmatic defects
in infants whose mothers were exposed to the ethanolamines, doxylamine and
diphenhydramine (Benadryl) during the first three months of pregnancy.34

Research dating back to 1971 (Kahison and Rosengren) has shown that elevated
levels of histamine can be detected in tissue undergoing rapid growth or
repair such as healing wounds or developing embryonic tissue. Inhibition of
histamine arrests fetal development in test animals.

Since ethanolamine antihistamines have both histamine and
cholinergic-blocking action, 35 their use during pregnancy has the potential
to disrupt the levels of these chemicals that are necessary for normal
growth at different stages of fetal development.

In addition to Bentyl and Decapryn, ingredients that interact and have the
potential for serious adverse effects together and individually, Bendectin
also contained pyridoxine, vitamin B-6. Pyridoxine was thought to be
beneficial in alleviating the symptoms of morning sickness although the
evidence on this is scanty.

Bendectin was promoted in nineteen countries as a safe and effective remedy
for morning sickness. Product sales soared. By the late '70's, Bendectin
ranked as the 91st most prescribed drug in the United States. It has been
estimated that over 33 million women worldwide received Bendectin.

Despite the drug's enormous popularity, questions about Bendectin's safety
continued to trickle in to the company and drug regulatory agencies around
the world. The company's standard reply to physicians reporting cases of
malformation was to assure them that no other cases had been reported, or
that such reports were extremely rare. The doctors would also receive copies
of the Bunde and Bowles Study to reassure them about Bendectin's safety.

Some FDA medical officers were not so convinced. After reviewing the safety
data on Bendectin, they asked the company to undertake additional animal
teratology studies. Merrell responded by producing tests of the individual
ingredients, but no new tests of the combination product.

In 1969, Dr Donald Patterson stirred up a new flurry of concern about
Bendectin's safety. He wrote a letter to the Canadian Medical Journal
reporting several cases of limb defects in children whose mothers had taken
Bendectin.36 That same year the German government held hearings on the
safety of Bendectin, but the company was able to convince the authorities
that there was no problem.37

The reports of congenital malformation kept coming in. Over half the cases
involved absent or partially missing limbs. Merrell dismissed this unusual
skewing toward limb defects as an increased tendancy to report any limb
malformation after the thalidomide episode.

Then in 1972, the company got a shock. Dr William McBride, who had first
linked thalidomide to limb defects, reported to the authorities that he
thought Bendectin was responsible for the births of three limbless babies in
Sydney. This confidential report somehow leaked to the press and made
headlines in Australia. 38'39'40 Soon Merrell was rushing to put out
brushfires of suspicion about Bendectin's safety in other parts of the world
as well.

On February 5, 1972, a woman in Milan gave birth to a daughter with a
phocomelic arm. This prominent Italian family arranged for a well-known
research institute to test all the medicine the mother had been given during
early pregnancy. As a result of these tests, the family's attorney wrote to
Merrell.

"The test of your product has given such an alarming result . to determine
the necessity of an immediate intervention.the existence of this danger
being clearly certified, it is hardly believable that this product can be
commercialized as a specified treatment for pregnancy nausea." 41

The company responded immediately that their scientists would meet with the
researchers from the Italian institute at any time, any place in the world.
The outcome of that meeting has never been made public. The government of
Japan requested additional studies with Bendectin. Instead of complying with
the request, the company voluntarily withdrew the product from the Japanese
market in 1974. 42

Since 1976, Bendectin has been the subject of continued controversy and
litigation in the United States and abroad. After the first large award to
the plaintiff in a 1983 Bendectin case, Merrell announced that they would no
longer manufacture Bendectin. They cited the increasing costs of litigation
as the motivating factor in the unprecedented move.

What are the facts? Does Bendectin cause birth defects or are the large jury
awards in some Bendectin cases just the result of kind-hearted juries who
feel sorry for deformed children. The proof lies in the evidence presented
to these juries. Four different types of data are required to prove that a
drug is teratogenic. These include:

1) Animal studies

2) In-vitro or cell culture studies

3) Human data, including epidemiological studies

4) Structural activity relationship

The scientific community considers information derived from all four of
these methods when determining whether a drug causes birth defects in the
developing embryo and fetus.

1) Animal studies

All drugs on the market today were first tested for safety in animals.
Different animals have different levels of sensitivity to different drugs.
For instance, humans are 700 times more sensitive to the teratogenic effects
of thalidomide than hamsters. Since a researcher cannot predict beforehand
which test animal may be sensitive to a particular drug, several species of
animals must be tested at varying dose levels.

Animal tests are used to predict the possibility of an adverse reaction in
even one in 10,000 or one in 100,000 people exposed to a drug. It is not
economically feasible to test a drug in 10,000 rats or rabbits, so
researchers test animals at much higher doses of a drug then humans would
ordinarily be exposed to. In this way, they have a better chance of
predicting whether a particular drug may cause cancer, birth defects or
other toxic effects in even a small percentage of human exposures.43

All drugs known to cause birth defects in humans have produced birth defects
in at least one species of rodent. In addition to rats and rabbits,
Bendectin and/or its ingredients has been tested in chickens, mice and four
kinds of monkeys. Independent studies were performed at the National Center
for Toxicological Research. As result of these studies, the National
Toxicological Program now lists Bendectin as a developmental toxicant. 44

Bendectin Animal Teratology Studies

1963 Staples Merrell 3-part Bendectin rabbits Clubbed limbs, sternal
defects. Kinked tail, abnormal head

1966 Merrell doxylamine rabbits Malformations in 40% of litters at highest
dose

1966 Merrell dicyclomine rabbits 67% resorption at highest dose

1975 Merrell dox + B-6 rats Cleft palate, hematoma, dilated kidney, pelvis,
agnatia

1981 McBride dicyclomine chicks Shortened limbs, exencephaly, gastroschisis

1981 McClure doxylamine rhesus monkeys Growth retardation

1982 Roll/Matthiaschk doxylamine rats Wavy ribs, diaphragmatic hernia

1984 McBride doxylamine rabbits Shortened limbs, micropthalmia, urogenital
defects

1984 NCTR doxylamine rats Delayed bone formation-skeleton especially,
metacarpals

1985 Hendricks, doxylamine macaque monkeys, rhesus monkeys, baboon,
Ventricular septal heart defects, one baboon with multiple heart defects and
limb reduction.

1985 McBride-doxylamine marmosets, Bowel and limb malformation

2) In-vitro or cell culture studies

Dr John Hassell from the National institute of Health studied the effect of
doxylamine on chondrogenesis in mouse limb bud cells. Chondrogenesis is the
ability of limb bud cells to differentiate and form cartilage, the precursor
of bone. When doxylamine was applied directly to these cells, it interfered
with the proper growth and differentiation of the mouse limb bud. 45

3) Human data, including epidemiological studies and individual case reports

Epidemiology is the field of medicine which tries to determine the cause(s)
of birth defects, cancer and other diseases by recording and comparing
incidence rates and possible etiological factors in different human
populations. Mathematical formulas have been devised that turn these
comparisons into an estimated risk of certain etiological factors being
associated with specific adverse outcomes.

In recent years, epidemiological studies have been considered one of the
most important tools for assessing a drug's potential to cause birth
defects. This reliance on epidemiology is questionable since scientific
experts have acknowledged that even thalidomide's association with birth
defects could not be clearly demonstrated using these same techniques.

Three factors must be taken into account in evaluating the reliability of an
epidemiology study. One: Who paid for the study? Industry financed studies
tend to agree with the corporate view of the product's safety. Two: How were
the raw data collected? A study is no better than the raw date on which it
is based. If there are discrepancies in any of the data, the outcome of the
entire study may be subject to reinterpretation.

Three: What was the purpose of the study? A study should be specifically
designed to answer a particular question. Reanalysis of old data from
studies designed to answer different questions may not yield valid results.

Despite the difficulties of the epidemiological approach, Bendectin has been
associated with malformations in both government and company sponsored
studies. In some cases, these associations became apparent when experts
reanalyzed the original raw data from the studies.

Bentectin Epidemiological Studies

Bunde/Bowes: Reanalysis of raw data indicates up to 80% risk of BDN exposed
baby having birth defect

CDC: Statistically significant association with aminiotic band limb defects
and encephalocele.

Heinonen: Data consistent for association of BDN with musculoskeletal
defects.

Jick: Data consistent with modest teratogenic effect on limbs, BDN exposure
increases risk of limb defect 120%

Michaelis: 36% increased risk of malformations in BDN exposed babies

Mitchell: 50% increased risk of limb defects in BDN exposed babies

Rothman: Statistically significant association with heart defects

Golding: Statistically significant association with oral clefts

Eskanaiz/Bracken: Statistically significant association with pyloric
stenosis

Smithells: 36% increased risk of malformation in BDN eaposed babies

Bass: 11-fold increase diaphragmatic hernia in BDN exposed babies

Maynard: Increase in diaphragmatic hernia in BDN exposed babies in analysis
of 5 cohort studies

Most human teratogens were not discovered through animal studies or
epidemiology. The disastrous effects of the rubella virus, thalidomide,
anti-convulsive medications and excessive alcohol consumption during
pregnancy were first reported by alert practioners.Physicians noticed a
pattern of malformations occurring in their patients and searched for a
common etiological factor.

Since the early 1960's the pattern of birth defects reported for Bendectin
has been heavily skewed toward limb reduction defects, part or all of a limb
or limbs missing. A review of case reports of malformations in the Bendectin
files at Merrell and the FDA reveal an extraordinarily high percentage
(one-half or more) of the total defects reported are limb defects. A 1972
interdepartment memorandum from Merrell's Research Director, Dr Carl Bunde
comments that in a review of Bendectin reports. "the type of abnormality
reported is weighted very heavily to skeletal types involving the
extremeties." 46

Dr. Alan Kimball Done, former Special Assistant to the Director of the
Bureau of Drugs at the FDA, testified in court that "one cannot find the
same kind of reporting anywhere in the literature or anywhere else of the
kinds of incidence we are talking about. with any drug other than
Bendectin."

Dr. William McBride reported that he was aware of 77 cases of children born
with limb reduction deformities or malformations of the external ear whose
mothers had proof they had taken Bendectin during the first 7 weeks of
pregnancy, the critical time of formation for these structures.47

In 1983, the Association of Birth Defect Children reviewed some 500 cases of
Bendectin associated birth defects reported to the organization. One-half of
these reports were limb defects.

A teratogen which can affect the limbs frequently causes defective
development of the heart as well since these structures are formed at almost
the same time. Thalidomide caused 14 different kinds of heart defects in
addition to phocomelic limbs. Bendectin reports also reveal an excess of
heart defects. In a review of over 3,000 cases of pediatric cardiac defects
at Boston Children's Hospital, as many as 1,000 cases listed a prenatal
exposure to Bendectin. The probability that Bendectin causes heart defects
is increased by the results of monkey studies showing an excess of
ventricular septal defects in Bendectin exposed offspring and birth defects
monitoring data which report that the incidence of ventricular septal
defects nearly tripled from the mid 1970's to 1981, years when sales of
Bendectin were at their highest.

Although most teratogens are identified by a particular pattern of birth
defects, they may also produce malformations of almost any part of the body
depending on the time of exposure and the genetic suseptibility of the
fetus. According to a report in the British Medical Journal in 1973,
thalidomide defects could be single or multiple involving almost any system
in the body; limb defects; defects of the eyes and ears; malformations of
internal organs including the heart, kidneys and gastrointestinal tract. 45

It may be years before the full spectrum of Bendectin related birth defects
is known. To date, studies and clusters of reports show an association
between Bendectin and the following malformations: limb defects, heart
malformations, defects of the eyes and ears, gastrointestinal malformations,
urogenital defects, oral clefts and certain kinds of central nervous system
defects.

4) Structural activity relationship

In the years since thalidomide, researchers have tried to determine how the
drug caused such tragic deformities. In 1971, Dr William McBride was awarded
a $40,000 international prize for his discovery that thalidomide caused
birth defects. He used the award money to set up Foundation 41, a research
institution that studies the first 40 weeks of life in the womb and the
first seven days outside the womb. Much of the research at Foundation 41
focused on investigating how thalidomide produced birth defects.

McBride and his team hypothesized that thalidomide damaged embryonic nerve
cells that are essential for the proper development of the limbs and other
organs. This theory has had support in the medical literature since the turn
of the century. In 1900, Schlesinger, a German researcher, suggested that a
combination of a limb and muscle defects might be caused by an injury to the
nerve supply rather than to the tissues themselves. 49

In 1966, Gordon suggested a neural basis for thalidomide malformations. He
postulated that thalidomide had a toxic effect on initial nerve impulses to
muscles in the organogenetic phase of development. He went on to correlate
birth defects in thalidomide babies with the peripheral nerve damage seen in
adults who took prolonged doses of the drug. 50

McBride's work on nerve injury preceding limb malformations included
research on Bendectin. Both active ingredients of Bendectin, dicyclomine and
doxylamine, have anticholinergic effects which are potentiated when the
drugs are combined. Anti-cholinergic or atropinic drugs block the passage of
nerve impulses through the parasympathetic nerves. In overdosage, these
drugs can cause the same effect as curare, paralysis of muscles and the
respiratory tract.

The effects of anticholinergics on morphogenesis have been studied since the
early 1900's. New data suggest that cholinergic nerves may be involved in
the phenomena of empryonic growth and differentiation particularly of the
muscles and limbs. Atropinic drugs have been shown to block embryonic
development in echinoderms, amphibia, chicks and ducks.51 McBride also
performed more experiments with atropine, hyoscine and dicyclomine in chicks
and rabbits which resulted in abnormal fetal development.52

One ingredient of Bendectin was shown to cause nerve injury in premarketing
tests. In 1951, Crescitelli and Geissman applied the antihistamine
doxylamine succinate to frog nerve fibers. The drug prevented the
transmission of nervous impulses and caused irreparable damage to the nerve
fiber.53 Many researchers believe embryonic cells are highly vulnerable to
the effects of drugs that can block nerve impulse transmission.

Summary

The proof that Bendectin causes birth defects is based on a composite of
evidence taken from animal studies, cell culture studies, human
epidemiology, case reports and studies of the drug's structure and
activities in the body. However, one important question is left unanswered
even by these methods. If Bendectin has the potential to cause birth
defects, why doesn't it cause malformations in every baby whose mother took
the drug? The Merrell Dow Company reminds the public in every press release
that over 33 million women worldwide have taken the drug.

Thalidomide, the most potent human teratogen known, caused birth defects in
approximately 20% of the babies exposed to the drug in early pregnancy. In
animal tests with thalidomide, some of the offspring would have typical limb
malformations while their litter mates would be normal. Although scientists
do not have all the answers yet, the most current research suggests the
following three factors may determine this difference in susceptibility to
teratogens:

1) The fetus exposed to the drug must be susceptible to its harmful effects.
Because of differences in genetic makeup, one baby may be harmed by a drug
while another shows no ill effects. It has been shown in animal tests that
one genetic strain of rodent will be far more susceptible to the teratogenic
effects of the drug than another.54

2) The drug must be taken at the critical time of fetal development. The
baby's organs and skeleton develop during the first 60 days of pregnancy.
This is the time when a drug exposure can cause major structural defects.
Although the most serious birth defects occur during the early part of fetal
development, toxic exposures can have adverse effects on such things as the
child's neurological development throughout the entire nine months of
pregnancy.

3) Some drugs may exert harmful effects only after they have reached the
fetus in sufficient doses. The amount of a drug that can cause a birth
defect may vary. The metabolism of a drug may be affected by a women's
height, weight, general health and nutritional status.

At the present time, scientists do not have the technology to determine
which babies are potentially at risk from any drug or chemical. Many drugs
and chemicals have structural and pharmacological activity similar to the
ingredients of Bendectin and theorectically would have the same potential to
injure the developing fetus. The safest course for a pregnant woman is to
avoid all unnecessary exposure to drugs and chemicals, including smoking and
alcohol, during the entire nine months of pregnancy.

FOOTNOTES

29 Favis, Gregory R., Facial Dyskinesia Related to Antihistamine", New
England Journal of Medicine, 294:730, 1976.

30 Brait, K.A. Zagerman, A.J., Dyskinesias After Antihistamine Use", New
England Journal of Medicine, 296:111,1977.

31 Lavenstein, B.L., Cantor F.K., "Acute Dystonia: An Unusual Reaction to
Diphenhydramine", JAMA 236:291, 1976

32 Saxen, Irma, "Cleft Palate and Maternal Diphenhydramine Intake", Lancet,
March 9, 1974, pp. 407-8.

33 Alia, F.M., Herranz, J.M., "Study on the Teratogenicity of Benadryl in
Rats", Arch de Farmacol y Toxicol 1977. 111:2. 157.

34 Rosa F., "Antihistamine Exposure in 30 Diaphragmatic Defects Among 50,
282 Outcomes in the Collaborative Perinatal Project", FDA memo 3/15/82

35 Patterson, D.C., Letter to the Editor, C Med Assn. Journal,
101:175-61969.

36 Sickness Pill May Cause Deformity", Perth Daily News, April 19, 1972.

37 Westhoff, Justin. Transcript of testimony during proceeding reviewing
Bendectin in West Germany. 10/7/80.

38 "Sickness Pill May Cause Defornity", Perth Daily News, April 19, 1972.

39 "Health Dept. Won't Talk On Limbless Baby Drug", Canberra News, April 19,
1972.

40 "Another Birth Drug Suspect", Sydney Morning Herald, April 19, 1972.

41 Auletta, A.M., letter to Richardson-Merrell, Inc., February 8, 1973.

42 Richardson-Merrell's answer to interrogatory #101, Mekdeci vs.
Richardson-Merrell, 1977.

43 Epstein, S.S., transcript of presentation on risk assessment for
environmental hazards, Case Western Reserve U. Med. School, p. 218

44 Schwetz, B.A., "Chemicals identified as Reproductive and Developmental
Toxicants", memo to Director NIEHS, Dept. HHS, February 19, 1987, p.2..

45 Hassell, J., Horigan E., "Chondrogenesis: A Model Developmental System
for Measuring Teratogenic Potential of Compounds", Laboratory of
Developmental Biology and Anomalies, National Institute of Dental Research,
NIH.

46 Bunde, C., Interdepartment memo, Richardson-Merrell, 1972.

47 McBride, W.G., Affadavit to federal court, Mekdeci vs.
Richardson-Merrell, July 1980.

48 Smithellis, R.W., "Defects and Disabilities of Thalidomide Children",
British Medical Journal, Feb 3, 1973, pp. 269-272.

49 Schlesinger, H., "ZurLehre vom Angeborenen Pectoralis-Rippendefect und
dem Hoch Stande der Scapula", Wienen Klinische Wochenschrift, 13:25-31,
1900.

50 Gordon, G., Develop. Med. Child Neurol. 8:761-767, 1966.

51 Karczmar, A.G., Srinivasan, R., Bennsohn, J., Cholinergic Function in the
Devoloping Fetus", Fetal Pharmacology, Raven Press, New York 1973, pp.
127-162

52 McBride, W.G. "The Effects of Anticholinergic Drugs on the Development of
the Chick Embryo", IRCS Medical Science, 8, 537, 1980.

53 Crescitelli, F., Geisman, T.A., "Certain Effects of Antihistamines and
Related Compounds on Frog Nerve Fibers", Amer. J. Physiol., 164:509-19.

54 Saxen, L., Rapola, J., "Congenital Defects", Holt, Rinehart and Winston,
New York, 1969, pp. 46-57. Dr" .

http://www.birthdefects.org/Research/bendectin2.htm

-- David Wright

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence.


Mark,

What does that mean?

Would you be happy if these kids never receive justice?

Donna


On Jun 10, 5:47 pm, Mark Probert wrote:
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...07/06/09/AR200...
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof

Isn't that sad!

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The DOJ attorneys are doing an excellent job of preparing for the trials.





By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06

For more than a decade, families across the country have been warring with
the medical establishment over their claims that routine childhood vaccines
are responsible for the nation's apparent epidemic of autism. In an
extraordinary proceeding that begins tomorrow, the battle will move from the
ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in
Washington that the vaccines can cause healthy and outgoing children to
withdraw into uncommunicative, autistic shells -- even though a large body
of evidence and expert opinion has found no link. The court has never heard
a case of such magnitude.

The shift from laboratory to courtroom means the outcome will hinge not on
scientific standards of evidence but on a legal standard of plausibility --
what one lawyer for the families called "50 percent and a feather." That may
make it easier for the plaintiffs to sway the panel of three "special
masters," which is why the decision could not only change the lives of
thousands of American families but also have a profound effect on the
decisions of parents around the world about whether to vaccinate their
children.

A victory by the plaintiffs, public health officials say, could increase the
number of children who are not given vaccines and fall sick or die from the
diseases they prevent.

Economics and politics intersect in the case with questions of health and
the deepening mystery of soaring autism rates. Advocates of the vaccine
theory have argued that the increase in cases was triggered by a
mercury-based preservative in vaccines that, they say, is toxic to
children's brains.

Under pressure from the advocates and to keep the issue from disrupting
vaccination programs, U.S. officials began phasing out the additive,
thimerosal, in children's vaccines around 1999 while maintaining that there
was no hard evidence that it was dangerous. But thimerosal is still used in
vaccines across much of the developing world. If the vaccine court decides
that the preservative caused autism, parents of children in poor countries
are likely to protest its inclusion, but removing it would make vaccines
much more expensive and potentially put them out of reach for many.

Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims,
where the case is to be heard, said he is aware of the larger ramifications.
But the court's job, he said, is only to focus on whether plaintiffs show a
plausible link between vaccines and autism.

About 20 experts are expected to testify in the case, which will involve a
staggering amount of complicated epidemiology and biochemistry. Golkiewicz
said a ruling could be a year off.

Experts for the government will argue that a range of epidemiological
studies found no link between vaccines and autism, as the prestigious
Institute of Medicine concluded in a 2004 report. The institute, part of the
National Academies that was chartered by Congress to advise the government
and the public on matters of science, dismissed the vaccine-autism theory,
which is mostly based on biochemistry studies on the toxic effects of
mercury.

Large international studies -- and preliminary evidence from the United
States -- suggest that after thimerosal was removed from children's
vaccines, autism rates continued to soar.

If thimerosal was the cause, removing it should have sharply lowered autism
rates, scientists say. Although definitive national evidence is not in --
children vaccinated after 1999 are just beginning to enter school, which is
the point at which many receive a diagnosis -- data from California suggest
that autism rates are continuing to climb steeply.

The cases are rising, experts say, primarily because of better diagnosis and
services: Parents and teachers are more attuned to the signs of autism, and
doctors are better equipped to spot it than they were two decades ago. Also,
the boundaries of the diagnosis have expanded to include a range of problems
under an umbrella known as autism spectrum disorders.

The plaintiffs acknowledge that their case is far from airtight
scientifically. But Kevin Conway, a Boston attorney representing the family
of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated
the opening test case for more than 4,800 plaintiffs, said that even if the
science is equivocal, he has a good legal argument, which is all he needs.

"There is a difference between scientific proof and legal proof," Conway
said. "One is 95 percent certainty, and the other is . . . 50 percent and a
feather."

Besides, Conway added, those who support the vaccine-autism theory did not
put all their eggs in the thimerosal basket. They are also arguing that
something else in vaccines might be making children sick.

Like many other advocates of the link, Conway said he believes that vaccines
in general are a good thing and have saved many lives. In an age of
bioterrorism, moreover, vaccines are not just a health priority but a
national security priority. But Congress's efforts to shield vaccine makers
from lawsuits over the rare but inevitable side effects of vaccines have
given the companies no incentive to make vaccines as safe as possible,
Conway said.

Congress set up the vaccine court to provide compensation for individuals
harmed by those side effects, because lawsuits were threatening to put
vaccine makers out of business.

The law requires people claiming they were harmed by a vaccine to bring the
case in the special court first, but if they lose, they can still file suit
in civil courts.

Scientific advocates for the vaccine-autism theory, such as the
father-and-son team of Mark and David Geier of Silver Spring, say fears
about damaging public health programs have prompted scientists and the
government to hide evidence of a problem. Many of the families believe that
the medical establishment and the U.S. Centers for Disease Control and
Prevention have conspired in a massive coverup.

Peter Hotez, president of the Sabin Vaccine Institute and a biology
professor at George Washington University, who has a 14-year-old autistic
daughter, said the controversy has distracted from the real problem: finding
services for rising numbers of autistic children and ramping up research to
find a cure.

"We are absolutely confident Rachel's vaccines have nothing to do with her
autism," he said. "If we could roll back the clock, we would give her all
the vaccines again."

But the family of severely autistic Michelle Cedillo, who arrived in
Washington on Friday for the trial, disagrees.

Michelle was a healthy 15-month-old when she was given the
measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so
words she had been able to speak -- including Mommy, Daddy, baby, kitty and
juice -- vanished. She developed a high fever one week after the shot and
went rapidly downhill. Today, she does not speak and is totally dependent on
caregivers. She suffers from seizures, arthritis and inflammatory bowel
disease and is nearly blind.

Cedillo said she is "not anti-vaccine" and not very interested in playing
the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We
want to focus on Michelle and find out what happened and get the help for
her that she needs."- Hide quoted text -

- Show quoted text -

Kevysmom wrote:
BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence.


Mark,

What does that mean?

Would you be happy if these kids never receive justice?

Donna

It has not been determined that the kids were damaged by their vaccines.
In fact, there is very little evidence that vaccines cause autism and
much that vaccines don't cause autism.

As sorry as I feel for these kids and their families, I don't see why
vaccine companies should pay when the vaccine don't cause autism.

jeff

David Wright wrote:
In article jk_ai.1543$wL5.1338@trndny04,
Mark Probert wrote:
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...9/AR2007060901
344.html?nav=rss_nation

Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof
Isn't that sad!

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The DOJ attorneys are doing an excellent job of preparing for the trials.

I hope so. Of course, when the Mercury Militia loses the case,
they'll just howl that it's all part of the Konspiracy and try
even harder. God forbid they ever cotton onto the idea that
they're off-track and would be better advised to try to look for
real solutions.

Agreed. Parents who have to deal with their child's autism need help.
Instead of ****ing away millions on useless "cures" and looking for some
mythical link to vaccines, the money could go to setting up programs and
finding real solutions.

One of the big concerns is that if the claimant's are successful, it
might lead to a dramatic decrease in uptake to be followed by a dramatic
rise in incidence with serious consequences.

Fortunately, the lead off PSC witness was more of a buffoon than a problem.

Kevysmom wrote:
BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence.


Mark,

What does that mean?

It means that the evidence presented by both sides will have to meet the
standard as set forth in the Daubert case. Look it up.

Would you be happy if these kids never receive justice?

Depends on what you call justice. If you mean having claims paid where
there is no evidence, I would be delighted if the cases were all
rejected. That is justice.

I would be ecstatic if the parents and the kids were able to get
whatever they need, whenever they need it. You may not call it
"justice", but I would call it the morally right thing to be done.


Donna


On Jun 10, 5:47 pm, Mark Probert wrote:
JOHN wrote:
http://www.washingtonpost.com/wp-dyn...07/06/09/AR200...
344.html?nav=rss_nation
Fight Over Vaccine-Autism Link Hits Court
Families, After Having Claims Rejected by Experts, Face Lower Burden of
Proof
Isn't that sad!

BTW, the special masters have already ruled that they will apply Daubert
standards to evaluate the evidence. This is NOT a lower burden of proof.

The DOJ attorneys are doing an excellent job of preparing for the trials.





By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06
For more than a decade, families across the country have been warring with
the medical establishment over their claims that routine childhood vaccines
are responsible for the nation's apparent epidemic of autism. In an
extraordinary proceeding that begins tomorrow, the battle will move from the
ivory tower to the courts.
Nearly 5,000 families will seek to convince a special "vaccine court" in
Washington that the vaccines can cause healthy and outgoing children to
withdraw into uncommunicative, autistic shells -- even though a large body
of evidence and expert opinion has found no link. The court has never heard
a case of such magnitude.
The shift from laboratory to courtroom means the outcome will hinge not on
scientific standards of evidence but on a legal standard of plausibility --
what one lawyer for the families called "50 percent and a feather." That may
make it easier for the plaintiffs to sway the panel of three "special
masters," which is why the decision could not only change the lives of
thousands of American families but also have a profound effect on the
decisions of parents around the world about whether to vaccinate their
children.
A victory by the plaintiffs, public health officials say, could increase the
number of children who are not given vaccines and fall sick or die from the
diseases they prevent.
Economics and politics intersect in the case with questions of health and
the deepening mystery of soaring autism rates. Advocates of the vaccine
theory have argued that the increase in cases was triggered by a
mercury-based preservative in vaccines that, they say, is toxic to
children's brains.
Under pressure from the advocates and to keep the issue from disrupting
vaccination programs, U.S. officials began phasing out the additive,
thimerosal, in children's vaccines around 1999 while maintaining that there
was no hard evidence that it was dangerous. But thimerosal is still used in
vaccines across much of the developing world. If the vaccine court decides
that the preservative caused autism, parents of children in poor countries
are likely to protest its inclusion, but removing it would make vaccines
much more expensive and potentially put them out of reach for many.
Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims,
where the case is to be heard, said he is aware of the larger ramifications.
But the court's job, he said, is only to focus on whether plaintiffs show a
plausible link between vaccines and autism.
About 20 experts are expected to testify in the case, which will involve a
staggering amount of complicated epidemiology and biochemistry. Golkiewicz
said a ruling could be a year off.
Experts for the government will argue that a range of epidemiological
studies found no link between vaccines and autism, as the prestigious
Institute of Medicine concluded in a 2004 report. The institute, part of the
National Academies that was chartered by Congress to advise the government
and the public on matters of science, dismissed the vaccine-autism theory,
which is mostly based on biochemistry studies on the toxic effects of
mercury.
Large international studies -- and preliminary evidence from the United
States -- suggest that after thimerosal was removed from children's
vaccines, autism rates continued to soar.
If thimerosal was the cause, removing it should have sharply lowered autism
rates, scientists say. Although definitive national evidence is not in --
children vaccinated after 1999 are just beginning to enter school, which is
the point at which many receive a diagnosis -- data from California suggest
that autism rates are continuing to climb steeply.
The cases are rising, experts say, primarily because of better diagnosis and
services: Parents and teachers are more attuned to the signs of autism, and
doctors are better equipped to spot it than they were two decades ago. Also,
the boundaries of the diagnosis have expanded to include a range of problems
under an umbrella known as autism spectrum disorders.
The plaintiffs acknowledge that their case is far from airtight
scientifically. But Kevin Conway, a Boston attorney representing the family
of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated
the opening test case for more than 4,800 plaintiffs, said that even if the
science is equivocal, he has a good legal argument, which is all he needs.
"There is a difference between scientific proof and legal proof," Conway
said. "One is 95 percent certainty, and the other is . . . 50 percent and a
feather."
Besides, Conway added, those who support the vaccine-autism theory did not
put all their eggs in the thimerosal basket. They are also arguing that
something else in vaccines might be making children sick.
Like many other advocates of the link, Conway said he believes that vaccines
in general are a good thing and have saved many lives. In an age of
bioterrorism, moreover, vaccines are not just a health priority but a
national security priority. But Congress's efforts to shield vaccine makers
from lawsuits over the rare but inevitable side effects of vaccines have
given the companies no incentive to make vaccines as safe as possible,
Conway said.
Congress set up the vaccine court to provide compensation for individuals
harmed by those side effects, because lawsuits were threatening to put
vaccine makers out of business.
The law requires people claiming they were harmed by a vaccine to bring the
case in the special court first, but if they lose, they can still file suit
in civil courts.
Scientific advocates for the vaccine-autism theory, such as the
father-and-son team of Mark and David Geier of Silver Spring, say fears
about damaging public health programs have prompted scientists and the
government to hide evidence of a problem. Many of the families believe that
the medical establishment and the U.S. Centers for Disease Control and
Prevention have conspired in a massive coverup.
Peter Hotez, president of the Sabin Vaccine Institute and a biology
professor at George Washington University, who has a 14-year-old autistic
daughter, said the controversy has distracted from the real problem: finding
services for rising numbers of autistic children and ramping up research to
find a cure.
"We are absolutely confident Rachel's vaccines have nothing to do with her
autism," he said. "If we could roll back the clock, we would give her all
the vaccines again."
But the family of severely autistic Michelle Cedillo, who arrived in
Washington on Friday for the trial, disagrees.
Michelle was a healthy 15-month-old when she was given the
measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so
words she had been able to speak -- including Mommy, Daddy, baby, kitty and
juice -- vanished. She developed a high fever one week after the shot and
went rapidly downhill. Today, she does not speak and is totally dependent on
caregivers. She suffers from seizures, arthritis and inflammatory bowel
disease and is nearly blind.
Cedillo said she is "not anti-vaccine" and not very interested in playing
the blame game or weighing in on matters of public policy.
"I am not a scientist. I am not a doctor," she said in an interview. "We
want to focus on Michelle and find out what happened and get the help for
her that she needs."- Hide quoted text -
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