's article posted by AHRP on govt. concession

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org and http://ahrp.blogspot.com

FYI

The US government has made an unprecedented concession in Federal

Court:mercury laced vaccines resulted in causing a child to become

autistic and the child is entitled to compensation.

Kirby, first to break the news in The Huffington Post (below)

on Feb. 25, wrote: " 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 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 a leading

neurologist 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 vaccinations

received

on July 19, 2000, significantly aggravated an underlying mitochondrial

disorder which predisposed her to deficits in cellular energy

metabolism,

and manifested as a regressive encephalopathy with features of ASD. "

However, 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.

The case is one of 4,900 autism cases currently pending in

Federal " Vaccine

Court. "

Kirby raises numerous speculative questions about the significance of

the

concession and how the government will proceed from here on:

How will the concession in this case affect the government position

in other

cases?

How many children with autism had an underlying mitochondrial

disorder?

What are the implications for medicine and public health?

If a significant minority of autism cases can be linked to

Mitochondrial

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?

Who will pay to clean up the mess of vaccine-caused disabling

conditions?

How will the concession affect public attitude about the safety of

vaccines?

Contact: Vera Hassner Sharav

veracare@...

212-595-8974

http://www.huffingtonpost.com/david-kirby/government-concedes-

vacci_b_88323.

html

Huffington Post

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

By Kirby

February 25, 2008

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 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.

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.

NOTE: Full text of the government's statement is posted here.

Kirby is the author of " Evidence of Harm - Mercury in Vaccines

and the

Autism Epidemic, A Medical Controversy " (St. s Press 2005.

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