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Subject: Government Concedes Vaccine-Autism Case in Federal Court - Now What?
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.
Read More: Autism, Autism Spectrum Disorder, Autism Thimerosal, Autism Vaccines, Concession, Hhs, Kennedy Krieger, Mitochondria, Oxydative Phosphorylation, Thimerosal, Vaccine, Vaccine Court, Breaking Living News http://www.huffingtonpost.com/david-kirby/government-concedes-vacci_b_88323.html
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.
NOTE: Full text of the government's statement is posted here.
David Kirby is the author of "Evidence of Harm - Mercury in Vaccines and the Autism Epidemic, A Medical Controversy" (St. Martins Press 2005.
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Comments (72)
0 comments pending FAQ: Comments & Moderation | FAQ: Huffpost Accounts Post a comment Tip expand collapse carolh (See profile | I'm a fan of carolh)
Has ANYONE even read my first post here? Does anyone even realize there is more than one thing in vaccines that are known to be related to the genes that cause autism? Free glutamic acid. Please folks, we won't get anywhere if we are each only examining our own navels. Try reading each others posts and opening your minds instead of just trying to push your own point of view. Free glutamic acid makes children have trouble making glutathione. This makes mercury REGARDLESS OF WHERE IT COMES FROM more dangerous. Mercury in a kid's TUNA sandwich becomes more toxic because of free glutamic acid in the VACCINES. If you keep tunnel vision on thimerosol alone, you are missing the elephant in the room.
Reply | Favorite | Flag as abusive | posted 12:25 PM on 02/28/2008 expand collapse kelp (See profile | I'm a fan of kelp)
Does anyone have links to more information on this November 9th filing? Were vaccines blamed in general, or thimerosal in partiular? I'd like to learn more about this.
Reply | Favorite | Flag as abusive | posted 12:54 PM on 02/26/2008 expand collapse MidwestDad (See profile | I'm a fan of MidwestDad)
The petitioners agreed to withdraw the test case after the respondents conceded that vaccines aggravated Hannah's pre-existing condition. It has nothing to do with thimerosal, or MMR, or a combination of the two.
Here is a link to the full text:
http://tinyurl.com/2wlpvo Reply | Parent | Favorite | Flag as abusive | posted 06:00 PM on 02/27/2008 expand collapse MidwestDad (See profile | I'm a fan of MidwestDad)
Good point Chapnalli, why did the petitioners' attorneys agree to removing this case? If you want to prove that vaccines cause autism, then why agree to strike a test case with a strong vaccine-autism link?
I think the likely explanation is that the test case does not come close to proving the link. Which means Mr.
Kirby's claim is suspect. He needs to release the document he supposedly has, otherwise his claim will remain suspect. How would that help our kids if Kirby's keeps everyone guessing and speculating? There's an easy way to end this right now.
Reply | Favorite | Flag as abusive | posted 10:12 AM on 02/26/2008 expand collapse Olerist (See profile | I'm a fan of Olerist)
The right to "remove" the case is not really up to the attorneys but rather the parents.
Reply | Parent | Favorite | Flag as abusive | posted 03:20 PM on 02/27/2008 expand collapse tiredmom (See profile | I'm a fan of tiredmom)
David Kirby nor his "claim" are suspect. The people complicit in injecting our children with known neurotoxins are.
The document?
http://www.ageofautism.com/2008/02/full-text-autis.html Reply | Parent | Favorite | Flag as abusive | posted 12:27 PM on 02/26/2008 expand collapse SLSL (See profile | I'm a fan of SLSL)
Please go to the link above and READ THE FACTS:
This child has a mitonchondrial disorder, as diagnosed by one of the foremost experts in the field. Learn & understand mito, and realize this case has NOTHING to do with the views you have regarding autism & vaccines.
I know most here are energized by this case's decision, but there is no connection whatsoever to this child's case and the majority of you here. Furthermore, if you read the case information and educate yourself on mitochondrial disorder, it becomes apparent that solely blaming vaccines, even in this case, is utterly inappropriate. I am dumbfounded by the decision made here. With all that is known about mitochondrial diseases, its symptoms and patterns, it cannot be said whether this child would not have had a regression without the vaccines. Additionally, who is supposed to be held accountable here? This child has a DISEASE that affects every organ in her body, no one knew that when she had her vaccines. Whose fault, exactly, is that?
Reply | Parent | Favorite | Flag as abusive | posted 01:02 PM on 02/26/2008 expand collapse Heaven (See profile | I'm a fan of Heaven)
It amazes me to read the comments posted. For the parents of autistic children who have done their research, it shows. Parents know their children more than anyone else and the countless stories of children being injured upon receiving vaccinations, speaks for itself. For those of you who have neglected to spend any time researching the toxicity of vaccinations alone, let alone any toxic metal additives, may you be blessed to see. Modern medicine has failed in its calling to be for the deception and greed of money has overcome the world at the expense of our children.
Reply | Parent | Favorite | Flag as abusive | posted 10:40 PM on 02/26/2008 expand collapse tbone99 (See profile | I'm a fan of tbone99)
The question is when did the mitochindrial damage occur ? or what activated it? very possibly vaccines!
Reply | Parent | Favorite | Flag as abusive | posted 05:54 PM on 02/26/2008 expand collapse AutismNewsBeat (See profile | I'm a fan of AutismNewsBeat)
That's just speculation.
Reply | Parent | Favorite | Flag as abusive | posted 09:21 PM on 02/27/2008 expand collapse tiredmom (See profile | I'm a fan of tiredmom)
The experts and officals in this case don't agree with ya, apparently.
Reply | Parent | Favorite | Flag as abusive | posted 01:08 PM on 02/26/2008 expand collapse nhokkanen (See profile | I'm a fan of nhokkanen)
Unfortunately I know the mother of a child with mitochondrial disorder who regressed each time she was vaccinated. Until she died at age 2, following more vaccines, and yet another seizure.
Studies indicate that mercury can cause mitochondrial damage. Mercury injected into infants and pregnant women via Thimerosal, which is STILL used in manufacture and chelated postproduction in varying degrees.
What is the harm in investigating parents' claims instead of denying them? Isn't healing a sick child the ultimate goal?
Children will keep being unnecessarily injured and dying until people finally get their minds around this sad vaccine paradox -- that a product intended to prevent disease may be causing it for a percentage of children.
Reply | Parent | Favorite | Flag as abusive | posted 03:04 PM on 02/26/2008 expand collapse MidwestDad (See profile | I'm a fan of MidwestDad)
Which issue of Medical Hypotheses has the study that indicates thimerosal as a causative agent for mitochondrial disorder?
Reply | Parent | Favorite | Flag as abusive | posted 03:56 PM on 02/26/2008 expand collapse CraigWilloughby (See profile | I'm a fan of CraigWilloughby)
I am a parent of a 6 year old boy who has ASD. Until 18 months of age, he was completely normal. He was walking, he was talking, and he was following all of the normal progression steps for a child his age (he was even a little bit ahead in some areas). Then, he had the DPT shot. The same night, his fever was at 105, and he could do nothing but scream. When we brought him to the ER, they asked us if he had received a vaccination, and we said yes. Their reply was, "Oh, this is normal." How can something like that be normal? The next day, his fever was gone, and he was listless. He hasn't spoken since. He quit walking until he was 2 and a half, and it's almost like he isn't my son anymore.
I've been keeping a close eye on this case because this has a direct effect on me and my family. Nearly every parent of an autistic child can pinpoint when the child began showing symptoms, and almost all of them will tell you that its within 3 days of a vaccination.
Reply | Favorite | Flag as abusive | posted 10:10 AM on 02/26/2008 expand collapse tbone99 (See profile | I'm a fan of tbone99)
I am so sorry to hear of you and your sons loss and hope the best for both.I am glad that parents such as yoursef are getting the word out to other parents in the midst of such tragedy.
Reply | Parent | Favorite | Flag as abusive | posted 05:56 PM on 02/26/2008 expand collapse MidwestDad (See profile | I'm a fan of MidwestDad)
"Nearly every parent of an autistic child can pinpoint when the child began showing symptoms, and almost all of them will tell you that its within 3 days of a vaccination."
Nearly all of them? Evidence?
Reply | Parent | Favorite | Flag as abusive | posted 03:57 PM on 02/26/2008 expand collapse CraigWilloughby (See profile | I'm a fan of CraigWilloughby)
Before I ask you if you are a parent of an autistic child, and also before I ask how much research you've done, I ask that you at least read up on the facts. Look around at the numerous articles of parents of autistic children.
Read Jenny McCarthy's story. Read Toni Braxton's story. Read Holly Robinson's story. All 3 of these parents can attribute vaccinations to their child's conditions. I belong to a large and growing community of parents of autistic children. Of the 200 and something people in the group, 90% of them can attribute the condition to a vaccination.
This is called a sampling. In a situation where an accurate approximation of a large populace is impossible, a sampling is adequate scientific evidence.
Reply | Parent | Favorite | Flag as abusive | posted 12:11 PM on 02/27/2008 expand collapse MidwestDad (See profile | I'm a fan of MidwestDad)
Yes, I'll be sure to check out Dr. McCarthy's book as soon as the medical library opens.
Reply | Parent | Favorite | Flag as abusive | posted 06:03 PM on 02/27/2008 expand collapse CraigWilloughby (See profile | I'm a fan of CraigWilloughby)
She doesn't have to be a doctor to FOLLOW FACTS.
FACT: Her son was following all milestones, and in many cases exceeding them )like my son.
FACT: Her son received a Tetanus Booster (which is known to contain Mercury). Within 72 hours, he had a high fever and was arching his back and screaming (like my son).
FACT: Soon after, he quit speaking and withdrew into himself. He quit meeting all developmental milestones and regressed on a few he had already met (like my son).
FACT: A few months later, he was diagnosed with ASD (like my son).
Now, based on these FACTS, what are we able to conclude? That there was some reaction to the vaccination.
Now, if it was just one parent having these problems, we could discount it as something else. But, what you are implying is that ALL OF THESE PARENTS WHO HAVE EXPERIENCED THIS EXACT SAME PROBLEM ARE CRAZY!
Read the FACTS.
Reply | Parent | Favorite | Flag as abusive | posted 11:00 AM on 02/28/2008 expand collapse AutismNewsBeat (See profile | I'm a fan of AutismNewsBeat)
How do you know McCarthy's "fact pattern" is true? You would help your credibility if you applied the same skepticism to Jenny McCarthy's claims as you do to real doctors.
McCarthy told Oprah that her son was a normal toddler until he received his measles, mumps and rubella vaccine (at 15 months of age). Yet in her book she writes "My friends" babies all cracked a smile way before Evan did . . . he was almost five months old."
Which is it? Was he normal until his MMR vaccine (which doesn't contain thimerosal? Or was he missing developmental milestones prior to 15 months?
I think some skepticism is in order. Do you?
Reply | Parent | Favorite | Flag as abusive | posted 11:49 AM on 02/28/2008 expand collapse CraigWilloughby (See profile | I'm a fan of CraigWilloughby)
Yes, there is always some skepticism in any claim. However, lets look at the other parents, those of us who have documented evidence that our children were normal before the shots (my son recieved his DPT in 2002, when thimerosal was still on the market).
My point is this: Are all of us wrong? How is it that one day, our children are normal, then the next, they withdraw? How is it that in so many of these cases, there is a similarity; that these symptoms began within 72 hours of a vaccination? And then the medical industry says there is no connection when all evidence points to the fact that these shots contain mercury, a known heavy metal poison. Yes, I look at their reports with a great deal of skepticism. You must realize that they are doing everything in their power to protect their butts. I say again, I don't think it is a single factor, but I think it is a key! And if it is a key factor, then the government and the medical agencies need to step up and help us! These are our children. My son is non-verbal. He will never lead a normal life; he will never have a job; he will never be able to care for himself; he will never have children. Being that you are a parent of an autistic child, I'm sure you must see where my anger and my frustration come from, and you must also see why I am looking for the truth. I have all of my son's medical records, and I have proof that he was meeting his developmental milestones until he received the DPT. And then, after his diagnoses, I begin doing research and discover all of these stories that echo what happened to my son almost word for word...
Reply | Parent | Favorite | Flag as abusive | posted 12:30 PM on 02/28/2008 expand collapse carolh (See profile | I'm a fan of carolh)