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VERY SIGNIFICANT - Government Concedes Vaccine-Autism Case in Federal Court - Now What?

Posted: Wed Feb 27, 2008 8:55 am
by Sheri Nakken
http://www.huffingtonpost.com/david-kir ... ci_b_88323.
html

Government Concedes Vaccine-Autism Case in Federal Court - Now What?

Posted February 25, 2008 | 12:42 PM (EST)

After years of insisting there is no evidence to link vaccines with the
onset of autism spectrum disorder (ASD), the US government has quietly
conceded a vaccine-autism case in the Court of Federal Claims.

The unprecedented concession was filed on November 9, and sealed to protect
the plaintiff's identify. It was obtained through individuals unrelated to
the case.

The claim, one of 4,900 autism cases currently pending in Federal "Vaccine
Court," was conceded by US Assistant Attorney General Peter Keisler and
other Justice Department officials, on behalf of the Department of Health
and Human Services, the "defendant" in all Vaccine Court cases.

The child's claim against the government -- that mercury-containing
vaccines were the cause of her autism -- was supposed to be one of three
"test cases" for the thimerosal-autism theory currently under consideration
by a three-member panel of Special Masters, the presiding justices in
Federal Claims Court.

Keisler wrote that medical personnel at the HHS Division of Vaccine Injury
Compensation (DVIC) had reviewed the case and "concluded that compensation
is appropriate."

The doctors conceded that the child was healthy and developing normally
until her 18-month well-baby visit, when she received vaccinations against
nine different diseases all at once (two contained thimerosal).

Days later, the girl began spiraling downward into a cascade of illnesses
and setbacks that, within months, presented as symptoms of autism,
including: No response to verbal direction; loss of language skills; no eye
contact; loss of "relatedness;" insomnia; incessant screaming; arching; and
"watching the florescent lights repeatedly during examination."

Seven months after vaccination, the patient was diagnosed by Dr. Andrew
Zimmerman, a leading neurologist at the Kennedy Krieger Children's Hospital
Neurology Clinic, with "regressive encephalopathy (brain disease) with
features consistent with autistic spectrum disorder, following normal
development." The girl also met the Diagnostic and Statistical Manual for
Mental Disorders (DSM-IV) official criteria for autism.

In its written concession, the government said the child had a pre-existing
mitochondrial disorder that was "aggravated" by her shots, and which
ultimately resulted in an ASD diagnosis.

"The vaccinations received on July 19, 2000, significantly aggravated an
underlying mitochondrial disorder," the concession says, "which predisposed
her to deficits in cellular energy metabolism, and manifested as a
regressive encephalopathy with features of ASD."

This statement is good news for the girl and her family, who will now be
compensated for the lifetime of care she will require. But its implications
for the larger vaccine-autism debate, and for public health policy in
general, are not as certain.

In fact, the government's concession seems to raise more questions than it
answers.

1) Is there a connection between vaccines, mitochondrial disorders and a
diagnosis of autism, at least in some cases?

Mitochondria, you may recall from biology class, are the little powerhouses
within cells that convert food into electrical energy, partly through a
complex process called "oxidative phosphorylation." If this process is
impaired, mitochondrial disorder will ensue.

The child in this case had several markers for Mt disease, which was
confirmed by muscle biopsy. Mt disease is often marked by lethargy, poor
muscle tone, poor food digestion and bowel problems, something found in
many children diagnosed with autism.

But mitochondrial disorders are rare in the general population, affecting
some 2-per-10,000 people (or just 0.2%). So with 4,900 cases filed in
Vaccine Court, this case should be the one and only, extremely rare
instance of Mt disease in all the autism proceedings.

But it is not.

Mitochondrial disorders are now thought to be the most common disease
associated with ASD. Some journal articles and other analyses have
estimated that 10% to 20% of all autism cases may involve mitochondrial
disorders, which would make them one thousand times more common among
people with ASD than the general population.

Another article, published in the Journal of Child Neurology and
co-authored by Dr. Zimmerman, showed that 38% of Kennedy Krieger Institute
autism patients studied had one marker for impaired oxidative
phosphorylation, and 47% had a second marker.

The authors -- who reported on a case-study of the same autism claim
conceded in Vaccine Court -- noted that "children who have
(mitochondrial-related) dysfunctional cellular energy metabolism might be
more prone to undergo autistic regression between 18 and 30 months of age
if they also have infections or immunizations at the same time."

An interesting aspect of Mt disease in autism is that, with ASD, the
mitochondrial disease seems to be milder than in "classic" cases of Mt
disorder. In fact, classic Mt disease is almost always inherited, either
passed down by the mother through mitochondrial DNA, or by both parents
through nuclear DNA.

In autism-related Mt disease, however, the disorder is not typically found
in other family members, and instead appears to be largely of the sporadic
variety, which may now account for 75% of all mitochondrial disorders.

Meanwhile, an informal survey of seven families of children with cases
currently pending in Vaccine Court revealed that all seven showed markers
for mitochondrial dysfunction, dating back to their earliest medical tests.
The facts in all seven claims mirror the case just conceded by the
government: Normal development followed by vaccination, immediate illness,
and rapid decline culminating in an autism diagnosis.

2) With 4,900 cases pending, and more coming, will the government concede
those with underlying Mt disease -- and if it not, will the Court award
compensation?

The Court will soon begin processing the 4900 cases pending before it. What
if 10% to 20% of them can demonstrate the same Mt disease and same set of
facts as those in the conceded case? Would the government be obliged to
concede 500, or even 1,000 cases? What impact would that have on public
opinion? And is there enough money currently in the vaccine injury fund to
cover so many settlements?

When asked for a comment last week about the court settlement, a spokesman
for HHS furnished the following written statement:
"DVIC has reviewed the scientific information concerning the allegation
that vaccines cause autism and has found no credible evidence to support
the claim. Accordingly, in every case under the Vaccine Act, DVIC has
maintained the position that vaccines do not cause autism, and has never
concluded in any case that autism was caused by vaccination."

3) If the government is claiming that vaccines did not "cause" autism, but
instead aggravated a condition to "manifest" as autism, isn't that a very
fine distinction?

For most affected families, such linguistic gymnastics is not so important.
And even if a vaccine injury "manifested" as autism in only one case, isn't
that still a significant development worthy of informing the public?

On the other hand, perhaps what the government is claiming is that
vaccination resulted in the symptoms of autism, but not in an actual,
factually correct diagnosis of autism itself.

4) If the government is claiming that this child does NOT have autism, then
how many other children might also have something else that merely "mimics"
autism?

Is it possible that 10%-20% of the cases that we now label as "autism," are
not autism at all, but rather some previously undefined "look-alike"
syndrome that merely presents as "features" of autism?

This question gets to the heart of what autism actually is. The disorder is
defined solely as a collection of features, nothing more. If you have the
features (and the diagnosis), you have the disorder. The underlying biology
is the great unknown.

But let's say the government does determine that these kids don't have
actual "autism" (something I speculated on HuffPost a year ago). Then
shouldn't the Feds go back and test all people with ASD for impaired
oxidative phosphorylation, perhaps reclassifying many of them?

If so, will we then see "autism" cases drop by tens, if not hundreds of
thousands of people? Will there be a corresponding ascension of a newly
described disorder, perhaps something like "Vaccine Aggravated
Mitochondrial Disease with Features of ASD?"

And if this child was technically "misdiagnosed" with DSM-IV autism by Dr
Zimmerman, how does he feel about HHS doctors issuing a second opinion
re-diagnosis of his patient, whom they presumably had neither met nor
examined? (Zimmerman declined an interview).

And along those lines, aren't Bush administration officials somewhat wary
of making long-distance, retroactive diagnoses from Washington, given that
the Terry Schiavo incident has not yet faded from national memory?

5) Was this child's Mt disease caused by a genetic mutation, as the
government implies, and wouldn't that have manifested as "ASD features"
anyway?

In the concession, the government notes that the patient had a "single
nucleotide change" in the mitochondrial DNA gene T2387C, implying that this
was the underlying cause of her manifested "features" of autism.

While it's true that some inherited forms of Mt disease can manifest as
developmental delays, (and even ASD in the form of Rhett Syndrome) these
forms are linked to identified genetic mutations, of which T2387C is not
involved. In fact little, if anything, is known about the function of this
particular gene.

What's more, there is no evidence that this girl, prior to vaccination,
suffered from any kind of "disorder" at all- genetic, mitochondrial or
otherwise. Some forms of Mt disease are so mild that the person is unaware
of being affected. This perfectly developing girl may have had Mt disorder
at the time of vaccination, but nobody detected, or even suspected it.

And, there is no evidence to suggest that this girl would have regressed
into symptoms consistent with a DSM-IV autism diagnosis without her
vaccinations. If there was such evidence, then why on earth would these
extremely well-funded government attorneys compensate this alleged injury
in Vaccine Court? Why wouldn't they move to dismiss, or at least fight the
case at trial?

6) What are the implications for research?

The concession raises at least two critical research questions: What are
the causes of Mt dysfunction; and how could vaccines aggravate that
dysfunction to the point of "autistic features?"

While some Mt disorders are clearly inherited, the "sporadic" form is
thought to account for 75% of all cases, according to the United
Mitochondrial Disease Foundation. So what causes sporadic Mt disease?
"Medicines or other toxins," says the Cleveland Clinic, a leading authority
on the subject.

Use of the AIDS drug AZT, for example, can cause Mt disorders by deleting
large segments of mitochondrial DNA. If that is the case, might other
exposures to drugs or toxins (i.e., thimerosal, mercury in fish, air
pollution, pesticides, live viruses) also cause sporadic Mt disease in
certain subsets of children, through similar genotoxic mechanisms?

Among the prime cellular targets of mercury are mitochondria, and
thimerosal-induced cell death has been associated with the depolarization
of mitochondrial membrane, according to the International Journal of
Molecular Medicine among several others. (Coincidently, the first case of
Mt disease was diagnosed in 1959, just 15 years after the first autism case
was named, and two decades after thimerosal's introduction as a vaccine
preservative.)

Regardless of its cause, shouldn't HHS sponsor research into Mt disease and
the biological mechanisms by which vaccines could aggravate the disorder?
We still do not know what it was, exactly, about this girl's vaccines that
aggravated her condition. Was it the thimerosal? The three live viruses?
The two attenuated viruses? Other ingredients like aluminum? A combination
of the above?

And of course, if vaccine injuries can aggravate Mt disease to the point of
manifesting as autism features, then what other underlying disorders or
conditions (genetic, autoimmune, allergic, etc.) might also be aggravated
to the same extent?

7) What are the implications for medicine and public health?

Should the government develop and approve new treatments for "aggravated
mitochondrial disease with ASD features?" Interestingly, many of the
treatments currently deployed in Mt disease (i.e., coenzyme Q10, vitamin
B-12, lipoic acid, biotin, dietary changes, etc.) are part of the
alternative treatment regimen that many parents use on their children with
ASD.

And, if a significant minority of autism cases can be linked to Mt disease
and vaccines, shouldn't these products one day carry an FDA Black Box
warning label, and shouldn't children with Mt disorders be exempt from
mandatory immunization?

8) What are the implications for the vaccine-autism debate?

It's too early to tell. But this concession could conceivably make it more
difficult for some officials to continue insisting there is "absolutely no
link" between vaccines and autism.

It also puts the Federal Government's Vaccine Court defense strategy
somewhat into jeopardy. DOJ lawyers and witnesses have argued that autism
is genetic, with no evidence to support an environmental component. And,
they insist, it's simply impossible to construct a chain of events linking
immunizations to the disorder.

Government officials may need to rethink their legal strategy, as well as
their public relations campaigns, given their own slightly contradictory
concession in this case.

9) What is the bottom line here?

The public, (including world leaders) will demand to know what is going on
inside the US Federal health establishment. Yes, as of now, n=1, a solitary
vaccine-autism concession. But what if n=10% or 20%? Who will pay to clean
up that mess?

The significance of this concession will unfortunately be fought over in
the usual, vitriolic way -- and I fully expect to be slammed for even
raising these questions. Despite that, the language of this concession
cannot be changed, or swept away.

Its key words are "aggravated" and "manifested." Without the aggravation of
the vaccines, it is uncertain that the manifestation would have occurred at
all.

When a kid with peanut allergy eats a peanut and dies, we don't say "his
underlying metabolic condition was significantly aggravated to the extent
of manifesting as an anaphylactic shock with features of death."

No, we say the peanut killed the poor boy. Remove the peanut from the
equation, and he would still be with us today.

Many people look forward to hearing more from HHS officials about why they
are settling this claim. But whatever their explanation, they cannot change
the fundamental facts of this extraordinary case:

The United State government is compensating at least one child for vaccine
injuries that resulted in a diagnosis of autism.

And that is big news, no matter how you want to say it.

David Kirby is the author of "Evidence of Harm - Mercury in Vaccines and
the Autism Epidemic, A Medical Controversy" (St. Martins Press 2005.

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath
http://www.wellwithin1.com/homeo.htm

Re: VERY SIGNIFICANT - Government Concedes Vaccine-Autism Case in Federal Court - Now What?

Posted: Wed Feb 27, 2008 2:32 pm
by Soroush Ebrahimi
From our friend Joy!

Regards

Soroush