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U.S. Federal Claims Court: Vaccines Caused Autism
http://talk.sheknows.com/f732/though...d-article-inte...
9:21 PM - Govt. Concedes Vaccine-Autism/Mito Case Thank you, Mom (aka "Mama Mia") for posting this very important landmark case. It shows that there is a connection between vaccines and the onset of some forms of autism and/or mitochondrial disorders. Mercury and other preservatives should be removed immediately from all vaccines -- including flu vaccines. All vaccines for children and adults should be safe and free of all mercury, preservatives, and other harmful ingredients. (MITOCHONDRIAL DISEASE AND AUTISM) 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 as filed on November 9, and sealed to protect the plaintiff's identity. 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 mitochondrial disease, which was confirmed by muscle biopsy. Mitochondrial 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 mitochondrial 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 mitochondrial disease in autism is that, with ASD, the mitochondrial disease seems to be milder than in "classic" cases of mitochondrial disorder. In fact, classic mitochondrial disease is almost always inherited, either passed down by the mother through mitochondrial DNA, or by both parents through nuclear DNA. In autism-related mitochondrial 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 mitochondrial 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 mitochondrial 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 mitochondrial 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 mitochondrial disease are so mild that the person is unaware of being affected. This perfectly developing girl may have had mitochondrial 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 mitochondrial dysfunction; and how could vaccines aggravate that dysfunction to the point of "autistic features?" While some mitochondrial 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 mitochondrial 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 mitochondrial 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 mitochondrial 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 mitochondrial 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 mitochondrial 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 mitochondrial 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 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? 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. ~~~~~~~~~~~~~~~~~~~~~~ February 28th, 2008 U.S. Federal Claims Court: Vaccines Caused Autism After years of denying any link between vaccinations in children and the onset of Autism, the U.S. Government quietly ruled in favor of a plaintiff today - a child who regressed into autism as a result of vaccinations. While I have never trusted shots, vaccines, or Rx pills in general, I knew something was wrong with the disproportionate number of Autistic children in this country compared to many other developed nations. Same for staggering numbers of Alzheimer's, cancer, obesity, and other diseases.but that's all information for a future post about how control of our health & wellness (which includes food supply) has directly affected so many of these epidemics. A Victory for the Victim Here is the story that came in today about the ruling, it is a great victory for all of those who were once victimized by the Department of Health's childhood vaccination schedule. Case documents state that the vaccines administered to the claimant significantly aggravated an underlying condition that ultimately led to regressive encephalopathy and symptoms of autism. According to official court documents, the child was developing normally until given the vaccines, and shortly after the shots, regressed into full autism. The child was diagnosed by nationally recognized autism medical specialists. For more than a decade, thousands of parents have come forward with reports of sharp regression in their children following immunizations. The cases of autism have dramatically spiked in the past 20 years to as many as 1 in 150 children, making it the leading childhood developmental disorder today. The National Autism Association (NAA) sees the ruling as confirmation of what so many parents have been saying for years. "This case echoes the stories of thousands of children across the country. With almost 5,000 similar cases pending in vaccine court, we are confident that this is just the first of many that will confirm what we have believed for so long, vaccines can and do cause children to regress into autism," says Wendy Fournier, parent and president of NAA. "We call on the Centers for Disease Control (CDC) to acknowledge that the current vaccine schedule is not safe for every child and as with the administration of any medicine, individual risks and susceptibilities must be considered for each patient." While thimerosal has been phased out of many pediatric vaccines, it is still used in flu shots recommended for pregnant women and children. At a meeting of the Advisory Committee for Immunization Practices held yesterday at the CDC, the committee voted to recommend annual flu shots for all children up to the age of 18, and to date has refused to state a preference for mercury-free vaccines. Skip the Mercury I don't know about you, but I think I'll pass on the flu shot, which is now being reported to not help anyways. I also don't think my future children need to be injected with mercury, especially at such a young age, when their bodies are so vulnerable. It's tragic that we have allowed the Government and the Department of Health to get by with injecting young children with poison for so long, but this victory is huge for the family who won, and hopefully will be instrumental in fostering change in our health policies. http://www.hearbydesign.com/2008/02/...s-court-vaccin... February 29, 2008 Feds Admit Vaccine "Aggravated" Autism ["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,'" he continues. "No, we say the peanut killed the poor boy. Remove the peanut from the equation, and he would still be with us today."] (World Net Daily) The federal government continues to deny a link between vaccines and autism, but the U.S. Court of Federal Claims has ruled in favor of a child alleged to have regressed into autism as a result of vaccinations. Several of the vaccinations included the controversial mercury-based preservative thimerosal, points out the National Autism Association, which sees the ruling as confirmation of the claims of many parents. This case echoes the stories of thousands of children across the country," said NAA President Wendy Fournier. "With almost 5,000 similar cases pending in vaccine court, we are confident that this is just the first of many that will confirm what we have believed for so long - vaccines can and do cause children to regress into autism." Fournier called on the Centers for Disease Control "to acknowledge that the current vaccine schedule is not safe for every child and as with the administration of any medicine, individual risks and susceptibilities must be considered for each patient." The government's unprecedented concession - filed Nov. 9 and sealed to protect the plaintiff's identity - was obtained through individuals unrelated to the case, said David Kirby, author of "Evidence of Harm: Mercury in Vaccines and The Autism Epidemic, A Medical Controversy." The concession was made by U.S. 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. A CDC panel, meanwhile, voted unanimously Wednesday to recommend flu shots for all school-age children. The move would compel private insurers to cover the costs and require the CDC to make the vaccine available to anyone who can't afford it. The NAA criticized the CDC decision, noting thimerosal is still found in flu shots recommended for children and pregnant women. Thimerosal in vaccines is suspected of causing brain damage and weakening the immune system, making some children susceptible later to infection from measles, mumps and rubella shots. Kirby, writing for the Huffington Post, reported the government's written concession said the child had a pre-existing mitochondrial disorder that was "aggravated" by her shots and ultimately resulted in a diagnosis of autism spectrum disorder, or 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," Kirby writes. "But its implications for the larger vaccine-autism debate, and for public health policy in general, are not as certain." The government's concession, he says, seems to raise more questions than it answers. The Department of Health and Human Services said its Division of Vaccine Injury Compensation, or 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." Kirby said that for most affected families, the fine distinction between claiming that vaccines did not "cause" autism but instead aggravated a condition to "manifest" as autism is a fine distinction that is not so important. While it's too early to tell, he said, "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, he said. "DOJ lawyers and witnesses have argued that autism is genetic, with no evidence to support an environmental component," he pointed out. "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." The bottom line, he said, is that the public will demand to know what is going on inside the U.S. federal health establishment. "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," Kirby writes. "Despite that, the language of this concession cannot be changed, or swept away." The key words contained in the concession, he says, are "aggravated" and "manifested." "Without the aggravation of the vaccines, it is uncertain that the manifestation would have occurred at all," Kirby argues. "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,'" he continues. "No, we say the peanut killed the poor boy. Remove the peanut from the equation, and he would still be with us today." Whatever the government's further explanation, says Kirby, "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." http://shankradioworldwide.typepad.c..._wide/2008/02/... |
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U.S. Federal Claims Court: Vaccines Caused Autism
Jan Drew wrote:
http://talk.sheknows.com/f732/though...d-article-inte... 9:21 PM - Govt. Concedes Vaccine-Autism/Mito Case Thank you, Mom (aka "Mama Mia") for posting this very important landmark case. It shows that there is a connection between vaccines and the onset of some forms of autism and/or mitochondrial disorders. Mercury and other preservatives should be removed immediately from all vaccines -- including flu vaccines. All vaccines for children and adults should be safe and free of all mercury, preservatives, and other harmful ingredients. (MITOCHONDRIAL DISEASE AND AUTISM) 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 government conceded that the vaccines *may have* aggravated that a mitochrondrial disorder, causing an encephalopathy, which has some autism-like symptoms. However, the government clearly did not say that the vaccines caused autism. Jeff |
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U.S. Federal Claims Court: Vaccines Caused Autism
"Jan Drew" wrote in message . net... http://talk.sheknows.com/f732/though...d-article-inte... 9:21 PM - Govt. Concedes Vaccine-Autism/Mito Case Thank you, Mom (aka "Mama Mia") for posting this very important landmark case. It shows that there is a connection between vaccines and the onset of some forms of autism and/or mitochondrial disorders. No. It does not show there is a connection. All it shows is that some people *think* there is a connection. In fact, the report you posted points out that the patient already had an underlying condition. Small (and unproven) risk of autism. Large (and proven) risk from deadly disease. Choice is yours. |
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U.S. Federal Claims Court: Vaccines Caused Autism
"Jeff" wrote in message news:hzoAj.1880$hr3.652@trnddc04... Jan Drew wrote: http://talk.sheknows.com/f732/though...d-article-inte... 9:21 PM - Govt. Concedes Vaccine-Autism/Mito Case Thank you, Mom (aka "Mama Mia") for posting this very important landmark case. It shows that there is a connection between vaccines and the onset of some forms of autism and/or mitochondrial disorders. Mercury and other preservatives should be removed immediately from all vaccines -- including flu vaccines. All vaccines for children and adults should be safe and free of all mercury, preservatives, and other harmful ingredients. (MITOCHONDRIAL DISEASE AND AUTISM) 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 government conceded that the vaccines *may have* aggravated that a mitochrondrial disorder, causing an encephalopathy, which has some autism-like symptoms. However, the government clearly did not say that the vaccines caused autism. Jeff The key words contained in the concession are *aggravated" and "manifested.* After years of denial. |
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U.S. Federal Claims Court: Vaccines Caused Autism
On Sun, 09 Mar 2008 04:50:37 GMT, "Jan Drew"
wrote: The government conceded that the vaccines *may have* aggravated that a mitochrondrial disorder, causing an encephalopathy, which has some autism-like symptoms. However, the government clearly did not say that the vaccines caused autism. The key words contained in the concession are *aggravated" and "manifested.* The key words you've left out following "aggravated" are those describing *what* may have been aggravated, which was "mitochondrial disorder", not autism. -- Terry |
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U.S. Federal Claims Court: Vaccines Caused Autism
Jan Drew wrote:
"Jeff" wrote in message news:hzoAj.1880$hr3.652@trnddc04... Jan Drew wrote: http://talk.sheknows.com/f732/though...d-article-inte... 9:21 PM - Govt. Concedes Vaccine-Autism/Mito Case Thank you, Mom (aka "Mama Mia") for posting this very important landmark case. It shows that there is a connection between vaccines and the onset of some forms of autism and/or mitochondrial disorders. Mercury and other preservatives should be removed immediately from all vaccines -- including flu vaccines. All vaccines for children and adults should be safe and free of all mercury, preservatives, and other harmful ingredients. (MITOCHONDRIAL DISEASE AND AUTISM) 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 government conceded that the vaccines *may have* aggravated that a mitochrondrial disorder, causing an encephalopathy, which has some autism-like symptoms. However, the government clearly did not say that the vaccines caused autism. Jeff The key words contained in the concession are *aggravated" and "manifested.* After years of denial. The other key point is that the kid did not have autism. |
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U.S. Federal Claims Court: Vaccines Caused Autism
http://www.huffingtonpost.com/david-...-_b_88558.html Government Concedes Vaccine-Autism Case in Federal Court - Now What? Posted February 25, 2008 | 12:42 PM (EST) -------------------------------------------------------------------------------- Read Mo Autism, Autism Spectrum Disorder, Autism Thimerosal, Autism Vaccines, Concession, Hhs, Kennedy Krieger, Mitochondria, Oxydative Phosphorylation, Thimerosal, Vaccine, Vaccine Court, Breaking Living News 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. 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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U.S. Federal Claims Court: Vaccines Caused Autism
"Jeff" Real one on HealthFraud list: Jeffrey Peter Joseph Utz, M.D. [2007] "Robert Watson" Jeff Utz Jeff Utz, M.D. Jeffrey P. Utz, M.D. Hence "Putz" http://www.msu.edu/~utz/ Jeffrey Peter, M.D. Wyle E. Coyote Jeff Utz (Jan 2003 & 2008 Jeff Jeff (2007 & 2008) |
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