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

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There you have it...Click the link if you can't access the links. http://www.huffingtonpost.com/david-kirby/government-concedes-vacci_b_88323.html Government Concedes Vaccine-Autism Case in Federal Court - Now What? David Kirby Journalist After years of insisting there is no evidence to link vaccines withthe onset of autism spectrum disorder (ASD), the US government has quietlyconceded a vaccine-autism case in the Court of Federal Claims. The unprecedented concession was filed on November 9, and sealed toprotect the plaintiff's identify. It was obtained through individualsunrelated 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 Keislerand other Justice Department officials, on behalf of the Department ofHealth and Human Services, the "defendant" in all Vaccine Court cases. The child's claim against the government -- that mercury-containingvaccines were the cause of her autism -- was supposed to be one of three"test cases" for the thimerosal-autism theory currently under considerationby a three-member panel of Special Masters, the presiding justices inFederal Claims Court. Keisler wrote that medical personnel at the HHS Division of VaccineInjury Compensation (DVIC) had reviewed the case and "concluded thatcompensation is appropriate." The doctors conceded that the child was healthy and developingnormally until her 18-month well-baby visit, when she received vaccinationsagainst nine different diseases all at once (two contained thimerosal). Days later, the girl began spiraling downward into a cascade ofillnesses and setbacks that, within months, presented as symptoms of autism,including: No response to verbal direction; loss of language skills; no eyecontact; 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'sHospital Neurology Clinic, with "regressive encephalopathy (brain disease)with features consistent with autistic spectrum disorder, following normaldevelopment." The girl also met the Diagnostic and Statistical Manual forMental Disorders (DSM-IV) official criteria for autism. In its written concession, the government said the child had apre-existing mitochondrial disorder that was "aggravated" by her shots, andwhich ultimately resulted in an ASD diagnosis. "The vaccinations received on July 19, 2000, significantly aggravatedan underlying mitochondrial disorder," the concession says, "whichpredisposed her to deficits in cellular energy metabolism, and manifested asa regressive encephalopathy with features of ASD." This statement is good news for the girl and her family, who will nowbe compensated for the lifetime of care she will require. But itsimplications for the larger vaccine-autism debate, and for public healthpolicy in general, are not as certain. In fact, the government's concession seems to raise more questionsthan it answers. 1) Is there a connection between vaccines, mitochondrial disorders anda diagnosis of autism, at least in some cases? Mitochondria, you may recall from biology class, are the littlepowerhouses within cells that convert food into electrical energy, partlythrough a complex process called "oxidative phosphorylation." If thisprocess is impaired, mitochondrial disorder will ensue. The child in this case had several markers for Mt disease, which wasconfirmed by muscle biopsy. Mt disease is often marked by lethargy, poormuscle tone, poor food digestion and bowel problems, something found in manychildren 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 filedin Vaccine Court, this case should be the one and only, extremely rareinstance of Mt disease in all the autism proceedings. But it is not. Mitochondrial disorders are now thought to be the most common diseaseassociated with ASD. Some journal articles and other analyses have estimatedthat 10% to 20% of all autism cases may involve mitochondrial disorders,which would make them one thousand times more common among people with ASDthan the general population. Another article, published in the Journal of Child Neurology andco-authored by Dr. Zimmerman, showed that 38% of Kennedy Krieger Instituteautism patients studied had one marker for impaired oxidativephosphorylation, and 47% had a second marker. The authors -- who reported on a case-study of the same autism claimconceded in Vaccine Court -- noted that "children who have(mitochondrial-related) dysfunctional cellular energy metabolism might bemore prone to undergo autistic regression between 18 and 30 months of age ifthey also have infections or immunizations at the same time." An interesting aspect of Mt disease in autism is that, with ASD, themitochondrial disease seems to be milder than in "classic" cases of Mtdisorder. In fact, classic Mt disease is almost always inherited, eitherpassed down by the mother through mitochondrial DNA, or by both parentsthrough nuclear DNA. In autism-related Mt disease, however, the disorder is not typicallyfound in other family members, and instead appears to be largely of thesporadic variety, which may now account for 75% of all mitochondrialdisorders. Meanwhile, an informal survey of seven families of children with casescurrently pending in Vaccine Court revealed that all seven showed markersfor mitochondrial dysfunction, dating back to their earliest medical tests.The facts in all seven claims mirror the case just conceded by thegovernment: 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 governmentconcede those with underlying Mt disease -- and if it not, will the Courtaward 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 setof facts as those in the conceded case? Would the government be obliged toconcede 500, or even 1,000 cases? What impact would that have on publicopinion? And is there enough money currently in the vaccine injury fund tocover so many settlements? When asked for a comment last week about the court settlement, aspokesman for HHS furnished the following written statement: "DVIC has reviewed the scientific information concerning theallegation that vaccines cause autism and has found no credible evidence tosupport the claim. Accordingly, in every case under the Vaccine Act, DVIChas maintained the position that vaccines do not cause autism, and has neverconcluded 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 avery fine distinction? For most affected families, such linguistic gymnastics is not soimportant. And even if a vaccine injury "manifested" as autism in only onecase, isn't that still a significant development worthy of informing thepublic? On the other hand, perhaps what the government is claiming is thatvaccination 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. Thedisorder is defined solely as a collection of features, nothing more. If youhave the features (and the diagnosis), you have the disorder. The underlyingbiology is the great unknown. But let's say the government does determine that these kids don't haveactual "autism" (something I speculated on HuffPost a year ago). Thenshouldn't the Feds go back and test all people with ASD for impairedoxidative phosphorylation, perhaps reclassifying many of them? If so, will we then see "autism" cases drop by tens, if not hundredsof thousands of people? Will there be a corresponding ascension of a newlydescribed disorder, perhaps something like "Vaccine Aggravated MitochondrialDisease with Features of ASD?" And if this child was technically "misdiagnosed" with DSM-IV autism byDr Zimmerman, how does he feel about HHS doctors issuing a second opinionre-diagnosis of his patient, whom they presumably had neither met norexamined? (Zimmerman declined an interview). And along those lines, aren't Bush administration officials somewhatwary of making long-distance, retroactive diagnoses from Washington, giventhat the Terry Schiavo incident has not yet faded from national memory? 5) Was this child's Mt disease caused by a genetic mutation, as thegovernment implies, and wouldn't that have manifested as "ASD features"anyway? In the concession, the government notes that the patient had a "singlenucleotide change" in the mitochondrial DNA gene T2387C, implying that thiswas the underlying cause of her manifested "features" of autism. While it's true that some inherited forms of Mt disease can manifestas developmental delays, (and even ASD in the form of Rhett Syndrome) theseforms are linked to identified genetic mutations, of which T2387C is notinvolved. In fact little, if anything, is known about the function of thisparticular gene. What's more, there is no evidence that this girl, prior tovaccination, suffered from any kind of "disorder" at all- genetic,mitochondrial or otherwise. Some forms of Mt disease are so mild that theperson is unaware of being affected. This perfectly developing girl may havehad Mt disorder at the time of vaccination, but nobody detected, or evensuspected it. And, there is no evidence to suggest that this girl would haveregressed into symptoms consistent with a DSM-IV autism diagnosis withouther vaccinations. If there was such evidence, then why on earth would theseextremely well-funded government attorneys compensate this alleged injury inVaccine Court? Why wouldn't they move to dismiss, or at least fight the caseat trial? 6) What are the implications for research? The concession raises at least two critical research questions: Whatare the causes of Mt dysfunction; and how could vaccines aggravate thatdysfunction to the point of "autistic features?" While some Mt disorders are clearly inherited, the "sporadic" form isthought to account for 75% of all cases, according to the UnitedMitochondrial Disease Foundation. So what causes sporadic Mt disease?"Medicines or other toxins," says the Cleveland Clinic, a leading authorityon the subject. Use of the AIDS drug AZT, for example, can cause Mt disorders bydeleting large segments of mitochondrial DNA. If that is the case, mightother exposures to drugs or toxins (i.e., thimerosal, mercury in fish, airpollution, pesticides, live viruses) also cause sporadic Mt disease incertain subsets of children, through similar genotoxic mechanisms? Among the prime cellular targets of mercury are mitochondria, andthimerosal-induced cell death has been associated with the depolarization ofmitochondrial membrane, according to the International Journal of MolecularMedicine among several others. (Coincidently, the first case of Mt diseasewas 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 Mtdisease and the biological mechanisms by which vaccines could aggravate thedisorder? We still do not know what it was, exactly, about this girl'svaccines that aggravated her condition. Was it the thimerosal? The threelive viruses? The two attenuated viruses? Other ingredients like aluminum? Acombination of the above? And of course, if vaccine injuries can aggravate Mt disease to thepoint of manifesting as autism features, then what other underlyingdisorders or conditions (genetic, autoimmune, allergic, etc.) might also beaggravated 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 ofthe treatments currently deployed in Mt disease (i.e., coenzyme Q10, vitaminB-12, lipoic acid, biotin, dietary changes, etc.) are part of thealternative treatment regimen that many parents use on their children withASD. And, if a significant minority of autism cases can be linked to Mtdisease and vaccines, shouldn't these products one day carry an FDA BlackBox warning label, and shouldn't children with Mt disorders be exempt frommandatory immunization? 8) What are the implications for the vaccine-autism debate? It's too early to tell. But this concession could conceivably make itmore difficult for some officials to continue insisting there is "absolutelyno link" between vaccines and autism. It also puts the Federal Government's Vaccine Court defense strategysomewhat into jeopardy. DOJ lawyers and witnesses have argued that autism isgenetic, with no evidence to support an environmental component. And, theyinsist, it's simply impossible to construct a chain of events linkingimmunizations to the disorder. Government officials may need to rethink their legal strategy, as wellas their public relations campaigns, given their own slightly contradictoryconcession in this case. 9) What is the bottom line here? The public, (including world leaders) will demand to know what isgoing on inside the US Federal health establishment. Yes, as of now, n=1, asolitary vaccine-autism concession. But what if n=10% or 20%? Who will payto clean up that mess? The significance of this concession will unfortunately be fought overin the usual, vitriolic way -- and I fully expect to be slammed for evenraising these questions. Despite that, the language of this concessioncannot be changed, or swept away. Its key words are "aggravated" and "manifested." Without theaggravation of the vaccines, it is uncertain that the manifestation wouldhave 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 theextent of manifesting as an anaphylactic shock with features of death." No, we say the peanut killed the poor boy. Remove the peanut from theequation, and he would still be with us today. Many people look forward to hearing more from HHS officials about whythey are settling this claim. But whatever their explanation, they cannotchange the fundamental facts of this extraordinary case: The United State government is compensating at least one child forvaccine 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 Vaccinesand the Autism Epidemic, A Medical Controversy" (St. Martins Press 2005. a.. 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