Federal "Vaccine Court,"

http://www.huffingtonpost.com/david-...r_b_51224.html

On Monday, one of the most important legal proceedings in American medical
history will get underway at the U.S. Court of Federal Claims in Washington.
There, a special panel of three judges will begin hearing evidence to
support -- and refute -- the hypothesis that mercury in vaccines and/or the
live-virus measles-mumps-rubella shot caused autism or autism-like symptoms
in some American children.

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Monday will mark the first time ever that evidence of autistic harm from
childhood vaccines is examined and cross-examined in a court of law. This is
far from a slam dunk case for either side, and the stakes - professional,
financial, emotional -- could not be more intense.

These three judges from the federal "Vaccine Court," as it is called, are
about to dip into the raging, contradictory waters of the vaccine-autism
contretemps, knowing they must emerge on the other side, each with their own
acutely anticipated decision about causation. Ultimately, they must deliver
judgment on some 4,800 claims that have been languishing in the system for
years.

I do not envy them their task.

Technically, at least, this is not a trial at all; it is an "Autism Omnibus
Proceeding" in a no-fault, supposedly non-adversarial adjudication. The
judges are not judges, but "Special Masters;" plaintiff families and their
lawyers are called "petitioners," and the defendant, called the
"respondent," is not some drug giant, but the Department of Health and Human
Services, represented by well-funded attorneys at the US Justice Department.

Any claims awarded in Vaccine Court are paid from a 75-cents-per-vaccine tax
footed by consumers, leaving vaccine makers free from liability.

But if even one case of causation is determined, then private lawsuits in
civil courts -- where the drug makers themselves are on trial -- would soon
flood the dockets. (Ironically, if families lose in Vaccine Court, they are
free to sue in civil court. Having autistic kids appear before sympathetic
juries is Big Pharma's big nightmare, and it's why a secret rider was
attached to the Homeland Security Act of 2002 to bar thimerosal cases from
civil court and force them into Vaccine Court).

Over the next three weeks, evidence on both sides of the first "test case"
will be picked apart to its bare bones, with one gaping exception.
Petitioners were just denied access to the government's vast vaccine safety
database of HMO patients, which was used by CDC officials to conduct a
four-year study that ultimately found no link between thimerosal and autism.
Earlier versions of the study, obtained through the Freedom of Information
Act, however, clearly showed increased risks for many neurodevelopmental
disorders, depending on the dose of thimerosal administered.

No wonder a special panel convened by the NIH recently issued a harsh
critique of the CDC's data collection and management, saying the study
contained "several serious problems... weaknesses and limitations" that
"reduce its usefulness" in proving or disproving causation.

And so, numbers culled from the government's massive database will be
submitted as Exhibit A for the defense, though the other side will be
forever barred from seeing the actual raw data, in order to replicate what
the CDC researchers found. (Exact replication is impossible because original
datasets, culled at taxpayer expense, somehow "went missing" and are no
longer available for re-analysis - a possible felony violation of the
federal Data Quality Act).

On the other hand, the burden of proof for plaintiffs is lower in Vaccine
Court than other federal courts, which could even things out a little.

Nearly all of the government's evidence will be "epidemiological" in
nature -- based on large population studies of computerized data. These
include the CDC study, plus similar research done in Sweden, Denmark and the
UK which found that, if anything, thimerosal had a "neuro-protective" effect
on children by apparently reducing their risk of autism.

Petitioning attorneys will counter that Federal Court rules regard
epidemiology alone as being "insufficient" to disprove causation, and will
surely use the NIH panel's critique of the government's own database as a
roadmap toward defanging the CDC's conclusions. To begin with, the CDC found
an autism rate of just 11-per-10,000 children at the largest participating
HMO, where the actual rate is currently 73-per-10,000. Why so many excluded
children, they will likely ask, and how did this affect the rate of
outcomes?

As for Denmark, petitioning lawyers will argue that autism case numbers
increased after 1992, when thimerosal was removed from childhood vaccines,
mostly because the Danish government happened to switch from counting
inpatient-diagnosed cases only -- about 13% of the total -- to counting all
inpatient AND outpatient cases nationwide. By 1999 the total number had
"gone up" to about 200 children a year, in a nation of 6.2 million people --
well below the current US rate of 1-in-150 kids, and not exactly a raging
epidemic.

The lawyers might also point out that incidence and prevalence rates of
autism actually declined in Denmark during 2000, and again (we now know,
only through FOIA) in 2001. And they could cite a media quote from Dr. Irva
Hertz-Picciotto, professor of public health at UC-Davis School of Medicine
and chair of the NIH panel that critiqued the CDC study. Flawed as the CDC
analysis was, she called it "an improvement on other studies, including the
two in Denmark, both of which had serious weaknesses in their designs."

For their side of the argument, family lawyers will present thousands of
pages of published "biological" science, as opposed to epidemiology. They
will examine data from animal models, test tube studies, and examinations of
children with autism; they will try to present a plausible biological
mechanism by which mercury (and to a lesser extent, MMR) could cause
autistic-like symptoms -- at the molecular, cellular, and clinical level.

Among this evidence is research suggesting that:

1) Many children with autism, probably due to genetics, are deficient in
certain sulfur-based proteins that defend against heavy metal accumulation
in humans. The proteins, which include glutathione, are called "thiols," and
sometimes "mercaptans," from the Latin mercurium captans, or literally
"mercury capturers."

2) Many children with autism show signs of heavy metal accumulation,
including elevated levels of proteins called "prophyrins" a bio-marker of
lead and mercury toxicity. They also present with low levels of mercury in
baby haircuts, (versus control children) suggesting a heavy metal "efflux
disorder" that prevents the proper metabolism and excretion of heavy metals.

3) Exposure to extremely low doses (micromolars) of thimerosal, previously
thought to be safe, shut down 25% of brain stem cells, in one lab study.

4) In another, low-level exposures of a few minutes duration killed many of
the immune system's "dendritic" cells, disrupted production of immune-system
messenger chemicals called "cytokines," and caused inflammation.

5) Meanwhile, many children with autism show signs of immune deficiency AND
hyperactivity, as well as cytokine imbalances and inflammation, (they also
show signs of chronic autoimmunity, where the immune system attacks the body
and brain).

6) Organic ethylmercury from thimerosal crosses the blood-brain barrier in
primates, where it quickly converts to inorganic mercury, which can remain
trapped in the brain for decades.

7) Inorganic mercury trapped in primate brains caused neuro-inflammation
(ie, rapid brain growth) by activating "glial" cells in the brain.

8) Autopsies on autistic human brains found chronic inflammation, apparently
linked to the brain's immune system and produced by activation of its
"glial" cells.

9) Another autopsy study also showed ongoing neuro-inflammation, possibly
from heavy metal exposure, and signs of autoimmunity. (Other studies have
found rapid brain growth in infants with autism.)

10) Thimerosal can disrupt a chemical process called "methylation," critical
for gene expression, neural function, memory and attention, and the
production of sulfur-based "thiol" proteins like glutathione.

Plaintiff lawyers will also show data from a study of birthday videos
proving that many kids with autism were meeting or exceeding developmental
milestones at age one, only to have tumbled into a wordless, autistic world
by age two. They will also show home videos of plaintiff children, before
and after their own regression, and in many cases, of the same children a
few years after experimental treatments -- including chelation (for heavy
metal removal) and methyl B-12 (for repair of methylation) -- that seem to
have vastly improved their condition.

At this point, government lawyers will surely try to discredit these
biological studies, one-by-one. They could succeed, though it will be tough,
given the data's provenance. Lead authors come from institutions such as
Harvard, Northeastern, Columbia, UC Davis, Johns Hopkins, and the
Universities of Washington, Arkansas, Kentucky and Rochester, and their
papers were published in peer-reviewed journals such as Molecular
Psychiatry, and the NIH's Environmental Health Perspectives.

The defense also has a few biological studies to support its side, including
one showing no difference in the mercury levels of blood and hair of typical
vs. autistic kids. But the mean age in this study was four years old, and
mercury does not linger around in blood or hair for that long.

Another study showed the thimerosal containing drug Rho-Gam (given to
pregnant women, and not a vaccine) did not increase the risk of autism in
children, though this study was funded by Johnson & Johnson, the product's
manufacturer and a potential thimerosal litigation defendant.

Likewise, the plaintiffs might offer some epidemiology, including one study
from the University of Texas showing increased rates of autism in school
districts near mercury-emitting coal power plants, and another, funded by
the CDC itself, where children with autism in the SF Bay Area were 50% more
likely to be born in the region's most mercury-polluted tracts, suggesting
"a potential association between autism and estimated metal concentrations."

Finally, expect to hear hours of testimony about California. Mercury was
phased out of childhood vaccines (except the flu shot) a few years ago, the
argument goes, so there should have been a drop in autism rates by now,
especially in California, which keeps the most reliable autism statistics.
It's a very powerful contention, but it may be too early to make any final
conclusions.

Among the youngest children, 3-to-5-year-olds, the number of cases was still
increasing after the first quarter of 2007. These kids were born and
vaccinated between 2002 and 2004, after thimerosal was removed from
vaccines, right?

It's true, most companies started making preservative-free vaccine in 2001,
but they also continued making product with thimerosal, as a backup during
the transition period. Little, if any of those mercury-containing vaccines
were ever recalled: They remained on the market, until they were finally
used up or expired, in 2003.

Government lawyers will likely point to a 2002 survey of vaccine providers,
conducted by the CDC, showing that just 2% of the pediatric shots contained
thimerosal. But this was a survey of providers under CDC contract only, and
CDC had a record of buying mercury-free vaccines for its clients (ie, state,
county and other public health clinics) even before 1999, when the federal
government called for the removal of thimerosal from the pediatric schedule
"as soon as possible."

It's not clear how many of the CDC contract providers surveyed were in
California, where the vast majority of children receive care in private
practices and large HMOs. Moreover, the CDC survey was merely a "convenience
sample," which are so inaccurate in representing the general population they
are virtually never used in published data. In fact, the US DOJ itself
defines them as "rarely useful in evaluation and usually hazardous."

Meanwhile, the state has quietly been tracking the number of autism cases by
birth year, as well as age group, meaning we can look at the very youngest
children entering the system. In the first quarter of 2003, there were 170
children with autism in the state system born in 2000 (or, roughly,
three-year-olds). In the first quarter of 2004, the number of
three-year-olds increased 8.2% to 184. In 2005 the same number went up 13%,
to 208, and in 2006 it jumped nearly 27% to 264. But this year, among kids
born in 2004, it was 251, a 5% drop.

This could be attributable to some quarterly reporting glitch, and the
caseload could easily be made up in the next quarter (that data will be out
in mid-July). But if the deficit continues, the 2004 birth cohort could
finish out as the first in which case numbers actually fell. (A similar
trend might be emerging at Northern California Kaiser, a major HMO).

Of course, it would take tremendous resources to get to the bottom of this,
lawyers might argue. One would need full medical records on each of those
251 kids born in 2004. Did any receive thimerosal still left in California
vaccines (or prenatally via Rho-Gam)? How many were exposed to mercury in
flu shots during pregnancy and as infants? And in a population that is now
one-quarter foreign born, how many children immigrated from countries where
immunization with thimerosal is now routine? (Vaccination coverage in Mexico
is now 92%).

Is immigration helping keep the California numbers up? We don't have that
data. But we do know that, since 2003, the rate of increase among white and
black children was 48.6% and 51.6%, respectively. Among Asian children,
however, it was 79%, and among Hispanics, 84.2%. Probably something worth
looking into (as well as the effect of aggressive early intervention
campaigns, which have consistently brought down the average age of diagnosis
and would likely drive up the number of three year olds in the system).

But again, this is epidemiology coming out of California, and the Special
Masters are looking at specific children with specific claims before their
court. Officials from the state have been warning all of us (and that
includes me) not to read too much into these numbers.

At the International Meeting For Autism Research last month, California
health officials presented their data along with this caveat: "Limitations
of the database and lack of individual exposure data prevent conclusions,
based on these data, about thimerosal as a cause or modifier of autism in a
specific subgroup or child."

It is entirely possible that thimerosal itself did not cause the autism
epidemic, but that is not what is on trial here. Even so, for the sake of
argument, let's say that a "specific subgroup" of people with autism, maybe
1%, was affected by mercury in their vaccines. With an estimated 1.5 million
Americans with autism, that would mean 15,000 people severely impacted by
thimerosal.

But, if causation can be shown in even 1% of cases, this would provide
tremendous hope for the other 99%. Yes, some cases may be purely genetic in
nature. But for everyone else, if we can show how thimerosal caused
"autism," we might be able to do the same for, say, pesticides, PCBs, flame
retardants, jet fuel, environmental mercury in air, water and fish, or any
combination thereof.

It's a tough call and, like I said, I don't envy these Special Masters,
though I do thank them for opening the proceedings to the public.

And I will see you in Vaccine Court.


David Kirby is author of the book "Evidence of Harm." Many of the studies
cited here can be found on his Powerpoint slides at www.evidenceofharm.com


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1. HRoger
Thank you, once again, for doing so much objective research. I hope that
many readers take a keener interest in this issue that affects so many
people's futures. I also pray for outcome from this trial to bring justice
for the individual victim as well as set a precedent that helps all of our
poisoned children.
June 07, 2007 at 09:34pm PM EDT | Flag as abusive
2. sophyalauren
Thank you, David, for all you do.
Sophia
June 07, 2007 at 09:52pm PM EDT | Flag as abusive
3. trustuswereexperts
Regardless of the trial's outcome, physicians must begin properly testing
and treating these children for mercury toxicity. Remove the root cause and
the cascade of mercury-related illnesses retreats.
A few years back one Midwest doctor was quoted in a newspaper article,
insistent that his autistic patients were not mercury toxic because he had
performed a blood test. As chemistry professor Boyd Haley would say, that's
like looking for malaria in Minnesota (though it is the land of ten trillion
mosquitoes).
June 07, 2007 at 10:09pm PM EDT | Flag as abusive
4. pattiallen816
I am a parent of an Autistic child born before 2002, and I am RH Negative
and recieved Rho-gam during my pregnancy and after.So if nothing else comes
of this at least it is creating awareness to parents reguarding vaccines.
And mabey they will tell us why they are still using Trimesol in Tetnus and
Flu shots and Rho-gam today. Thank you for your help.
June 08, 2007 at 01:01am AM EDT | Flag as abusive
5. Desiderata
This was the real reason the Imus incident was hyped. Big Pharma wanted him
silenced on this matter. MSNBC and CBS earns millions of dollars in drug
advertising dollars yearly, and Imus was a threat to that bounty.
June 08, 2007 at 03:44am AM EDT | Flag as abusive
6. Heraldblog
David, you wrote:

"Another study showed the thimerosal containing drug Rho-Gam (given to
pregnant women, and not a vaccine) did not increase the risk of autism in
children, though this study was funded by Johnson & Johnson, the product's
manufacturer and a potential thimerosal litigation defendant."

Dr. Mark Geier, one of the petitioners' "experts" in the omnibus
proceedings, was disallowed as an expert in a RhoGam suit. Geier told a
judge that he could not cite a single study that conclusively demonstrated a
connection between mercury and autism. When not under oath, Geier tells his
patients quite the opposite.

Fooling the special masters is not the same as fooling your fans.
June 08, 2007 at 07:43am AM EDT | Flag as abusive
7. lms
thank you for one of the most honest looks at the thimerosal problem I have
ever seen. I dont know if mercury has caused all of the problems we are
seeing. I am amazed that the CDC does not honestly study the problem. (they
usually have a conclusion before they start) I do know I had a
life-threatening reaction to the flu vaccine in October of 2005. It is a
known, not uncommon reaction. Life for me will never be the same. I am just
looking for honestly in the vaccine debate. thank you
June 08, 2007 at 09:55am AM EDT | Flag as abusive
8. Topley
Thank you David. Very thorough, well-organized and informative post.

Heraldblog: The Geiers are very easy, frequent, targets. Your post if
desperate and misleading. We as parents are not pinning all of our
hopes/convictions to the Geier's opinion/reputation, or any single person
for that matter. We are evaluating evidence as scientifically as we know how
and making judgements based on our personal experiences with our children.
As I said earlier, the Geiers have become an easy target. What about Jill
James? Mady Hornig? Andy Wakefield? Richard Deth? Thomas Burbacher? and the
rest? Are all these people frauds?
June 08, 2007 at 01:04pm PM EDT | Flag as abusive
9. BirgitCalhoun
Thank you, Daid Kirby, for your intelligent comments about the upcoming
vaccine court. I have one added comment: I talked to my son's case worker of
our local Regional Center in California. He mentioned that although the
number of autism cases was up, the number of mentally retarded was down by
quite a bit since all the clamoring about thimerosal etc. began in the late
'90s. Could it be hat fewer mentaly retarded equals more autism? I am a firm
believer that autism and many other mental states are caused by mercury. But
diagnosing autism has never been the doctors' strong suit.
June 08, 2007 at 04:15pm PM EDT | Flag as abusive
10. camsalis
Nice article. Good luck. CDC has the wherewithal and certainly the brains to
keep track of data -'losing it' is simply unheard of - and to reach
defensible conclusions. After Bush is gone maybe scientific inquiry will no
longer be guided by the sucking up of his appointed, deer-in-the-headlights,
agency directors. Maybe CDC will then be able to get back on track along
with the rest of the scientific community.
June 08, 2007 at 08:21pm PM EDT | Flag as abusive
11. foe2hg
Thanks David for putting the facts together so well. Since vaccines are a
sacred and often times a taboo topic, this first case should be very
significant. If children were either injured by MMR, thimerosal, or a
combination, let justice be done. This issue had been smoldering for years
and discussed politically, from a public health stance, and now it is time
for the legal system to look at the evidence. Let's hope that it is judged
fairly, honestly, and without interference from those who do not want
vaccines to be scrutinized.

Some in the media are already quoting vaccine "experts" and proponents of
the vaccine program, thus giving a message that to even ponder that a
vaccine could cause a specific injury/diagnosis is wrong. These cases are
about individuals, lives, and not a vaccine program.

Thanks again

Teresa
June 08, 2007 at 09:27pm PM EDT | Flag as abusive
12. rng777
Very well written article however their have been so many odd changes of
late to the Vaccine Injury Programs normal procedures:1.the appointing of
two additional Special Masters 2. the appointing of special Federal court
that will give the final say in any decision that is made that it causes one
to question if the "fix is already in"

Richard
June 09, 2007 at 01:07am AM EDT | Flag as abusive
13. typicalpol
Finally someone in a national media source unlike Paul "PR"Offit trying to
"control the message" and direct the narrative about the poor victimized
vaccine makers who are just trying to help (and make billions in the
process) before they end up in front of a jury to answer for their
maleficence.
June 09, 2007 at 12:13pm PM EDT | Flag as abusive
14. AlysMom
David,
Thank you for this in-depth post. You actually gave me hope that something
good may come out of this for the children.
June 09, 2007 at 02:49pm PM EDT | Flag as abusive
15. NOTOMMR
Well done again David always a delight to read your articles always
fact.Good luck everyone on Monday we just finished up in court in the UK
yesterday where samples of the kids in the UK are going to be used in the
States against the petitioners .We tried to stop this tooth and nail but we
failed and it wasnt for the fight that was fought by our lwyer who
represented the families for free.Hope beats fear every time.
June 09, 2007 at 05:59pm PM EDT | Flag as abusive
16. gabsmom
God bless you David.
June 09, 2007 at 06:52pm PM EDT | Flag as abusive
17. jeffmom
Thank you David for keeping this story alive, the facts straight and the
public aware. We need you NOW more than ever.
June 09, 2007 at 09:04pm PM EDT | Flag as abusive
18. sophyalauren
The coverup will continue. Admitting any part of responsibility could nearly
bankrupt "big pharma". Too many children have been injured,
poisioned...their lives taken from them. Even if there is one shred of
evidence that this is possible, why not just STOP. Stop adding vaccines to
the schedule. STOP injecting infants and pregnant women with live viruses
and chemicals that are known to be toxic. Stop and rethink. Do they think
this is just going to "go away?" when seemingly the numbers are increasing?
Better diagnosis? Sure. But why so many children? We may be better at
diagnosing because developmental disabilities are seen so often, when never
before. Why is this happening? Why spend precious time and money arguing.
You'd have to be blind not to KNOW something that was not happening before
is happening NOW.
June 09, 2007 at 09:30pm PM EDT | Flag as abusive
19. truthcanhurt
Make it go right Mr. Kirby!




http://www.newstarget.com/autism...
June 09, 2007 at 09:45pm PM EDT | Flag as abusive
20. Dawnofparadise41
I pray to God something is done through all of this. My 4 1/2 yr old who
will be 5 next month has Autism due to the MMR shots. The pediatrician keeps
telling me that is a misconception, but I know my child! My child was very
normal until he received those shots! I want you to know that as a mother of
an Autistic child, I am very grateful to you and all you are doing for ALL
of us! I wish I could be there with you Monday to support this. May God
bless you & your family for what you are doing!
Dawn
June 09, 2007 at 10:20pm PM EDT | Flag as abusive
21. alster
Thank you David again for your continued work.
I am praying for a Miracle on this issue, its way past time for the world to
know. Don't you know the Pharma world is sweating each night.
June 09, 2007 at 10:26pm PM EDT | Flag as abusive
22. hopefulmom
Do we know the names of the lawyers and judges involved? I am a strong
believer of prayer. With the current tone and disbelief in the causes of
Autism. I believe we need all the help we can get to find the true answers
to these questions, and once more combat the wealthy drug companies. If we
were all to pray for these people fighting the fight and also making
decisions, who knows what kind of difference it would make. Just a thought.
June 10, 2007 at 07:03am AM EDT | Flag as abusive
23. usna73
As always, Mr. Kirby has done an excellent job of presenting the essence of
the issues surrounding the upcoming vaccine hearings. The journalism is very
credible.

As the lead plaintiff in the complaint filed in U.S. District Court in 1992,
I must remind all of the interested parties that politics remain the shroud
covering the ability to honestly and scrupulously get to justice. In fact,
the Homeland Security "Lilly Rider" only suddenly appeared after our
litigation was "stayed", something never before seen in similar cases.

As we have seen from Agent Orange(I'm a Vietnam era product) to tobacco
makers and all things big business and special interests, we have learned
that the role of the Federal government is suspect in getting to the truth.
I think it is imperative that journalists, and in fact each of us, must
shine the spotlight on the Vaccine proceedings, to be sure that the American
public pays attention to the events and their resultant activity. After all,
it will be the taxpayers who foot the bill one way or another to care for
the hopelessly disabled children, my son included, as the society finds
itself overcome with adults who will be thrust into social service agencies
that cannot cope with the burdens.

These cases are now and forever will be about the concept of justice. If we,
as Amercians, ignore the need to be vigilant in the protection of the rights
of those least able to defend themselves, children irreparably harmed, then
we will be given the fate of a failed democratic republic.
June 10, 2007 at 07:58am AM EDT | Flag as abusive
24. mikkelsmom
May God be with you as you fight for justice for our children.
June 10, 2007 at 10:13am AM EDT | Flag as abusive
25. fanbelt
Greetings All
I have been an advocate for children with autism now for about two years. I
have done a tremendous amount of researh and I recieve news feeds from all
over the world. There are a few main points that I have become convinced of
during my research. One is that there is definately a link between autism
and thimerosal. Two, there is a massive cover up being orchestrated by the
government and Big Pharma. Here are some of the reason I have come to the
conclusions I have.
Thimerosal has been banned from use in no less than 8 countries based on
studies that have shown that the mercury in childhood vaccinations has been
inplicit in cases of neurological damage and the increase in the number of
autism cases. For me, the most significant research supporting the
mercury/autism link was done in the Amish communities. Amish people do not
vaccinate their children and autism is non existant in their lives. I am
convinced that our government will do anything to protect the interests of
the big corporations in America. The parents of children with autism are to
me, the best indicator of how their children got sick. They report
consistantly that their children were fine untill they were vaccinated. This
alone should be cause for the government to rule even on the side of error
when there is such a profound health risk involved.
One final thought of mine is on the subject of accountability. Even if fault
is found on the part of the pharmacuetical companies and the government,
there is no intent on either of their parts to make restitution to the
victims of their crimes. Without accountability there is little need for
fact finding or research because the end result will be the same either way.
bIG PROFITS FOR CORPORATE aMERICA. pAIN AND SUFFERING FOR THE VICTIMS OF
SUCH GROSS NEGLIGENCE.