This one might have significant financial implications...

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

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

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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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