David Kirby and the government "concession that vaccines cause autism": The incredible shrinking causation claim

I didn't want to blog about this. I really didn't.

No, the reason why I didn't want to blog about this latest screed by mercury militia enabler David Kirby is not because it is about any sort of slam-dunk proof that vaccines do after all cause autism, a mistaken impression that you might get if you just looked at the crowing throughout the antivaccination blogosphere. Rather, it's because I've been forced once again to wade through Kirby's smug, self-congratulatory, and intentionally obfuscatory prose to try to figure out just what the hell he was talking about and then try to make sense of the actual story that he is crowing about and the nine questions in boldface he oh-so-triumphantly asks.

It's enough to drive a skeptical blogger to throw up his hands. Fortunately, this skeptical blogger is made of sterner stuff (although I did refrain from the temptation to blog about this immediately), and it's worth delving into the muck that is David Kirby's purple prose because it realizes just how much the antivaccinationists have allowed their claims about vaccines and autism to shrink from what they were saying just a few years ago.

What has Kirby all hot with excitement is a report that on November 9, 2007, the government conceded one of the vaccine injury cases in the Autism Omnibus. Before I deal with Kirby's premature gloating, I thought a little background would be in order. As you may recall, the Autism Omnibus is the name given to a huge case in which nearly 5,000 parents who believe their children's autism was somehow caused by vaccines are applying to the Vaccine Injury Compensation Program (VICP). In the proceedings, overseen by Special Masters, several "test cases" were chosen, the first of which was Michelle Cedillo. The rulings on the plausibility of whether vaccines caused the autism of the plaintiffs in these test cases will determine whether the remaining thousands of cases can go forward. One thing that you should definitely remember when reading David Kirby's blather is that we are talking about legal plausibility, not scientific plausibility here. The way the Autism Omnibus proceedings are set up is to make the bar that the plaintiffs must jump with the evidence quite low, specifically on the legal standard of plausibility, which in essence means "51% probability," or, as one lawyer for the families called the standard "50% and a feather." Also remember that the entire VICP is set up to compensate any injury clearly caused by a vaccine. This is the case even if the evidence is not clear cut enough to meet a strictly medical or scientific standard. Indeed, let's take a trip back in time to June to see what I said about the Omnibus when it first started:

The problem is that scientific and epidemiological evidence ultimately may not matter in this case. As Steve Novella points out, there is history to support a pessimistic viewpoint regarding the ultimate outcome of the Autism Omnibus, specifically the case of silicone breast implants and their alleged link to autoimmune disorders and cancer. Based on poor quality studies purporting to show a correlation between these implants and a wide variety of autoimmune diseases, hordes of activists waged legal war against Dow Corning, in essence suing it into bankruptcy. More recent studies fail to find a link between silicone implants and autoimmune disease. Certainly, there are risks of local complications, such as implant rupture and capsular contracture, but the risk of connective tissue disorders and autoimmune disease is not elevated in women with silicone implants.

If you think the same thing that happened with silicone breast implants can't happen with vaccines, think again.

I hope I wasn't prophetic.

Be that as it may, it is not in the least bit surprising that the government has agreed to settle one case so far. Even so, just because the standard of evidence is so low doesn't mean there might not be a link in this particular case. Consequently, it's reasonable to ask if there indeed was anything in this case that is strong evidence that vaccines cause autism. In other words, we want to know if this case is, as the ever-histrionic and ever-idiotic Kent Heckenlively gloats, evidence that: "The sky has fallen. The fat lady has sung. Pigs are flying." or that "The government just dropped its pants." Let's just say that the best thing that can be said about Kent is that his commentary on this case is less over-the-top than it was when he wrote about toxins in vaccines. But only barely.

But let's get back to David Kirby, who begins:

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.

I first have to wonder where Kirby got a copy of a "sealed ruling" that was sealed to "protect the plaintiff's identity." Courts generally don't look kindly on a journalist publishing excerpts from a sealed ruling, especially when the ruling concerns a minor. Even worse, that propaganda organ for the mercury militia, Age of Autism, has posted the entire ruling. Reading it, given the unusually close correlation between the last round of vaccines and the permanent deterioration involved, I think the case may well represent a rare true vaccine injury. Be that as it may, it allows us to examine the ruling and determine that Kirby is playing semantic games with it to make it sound as though the government is making some sort of bombshell of a concession, as a brief summary of the case will demonstrate.

Basically, the plaintiff (noted as "CHILD" in the ruling) was born in December 1998 to a mother who suffered from gestational diabetes. The child received her normal vaccines (listed in the ruling) without incident. At seven months of age, the child developed the first of bouts of recurrent otitis media that ultimately required the placement of tubes. Because of the child's recurrent otitis media, the mother didn't allow her child to be vaccinated with standard 12 and 15 month vaccines. Through it all, the child met the normal developmental milestones through the first 18 months of her life and showed no signs of autism or ASD. At the July 19, 2000 examination, the child received the DTaP, Hib, MMR, Varivax, and IPV vaccinations. Two days later, the child developed a fever to 102.3° F, exhibiting a high-pitched scream and a decreased reaction to stimuli. During the next few months, the child had several visits to her pediatrician due to fevers, rashes, and bouts of otitis media requiring tubes again. By November, the child had been noted to have lost some language skills. To make a long story short, the child was diagnosed with an "encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness." Ultimately, a metabolic disorder, specifically a mitochondrial disorder was suspected, and ultimately confirmed through genetic testing, which showed "a mitochondrial DNA ("mtDNA") point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C)." As part of her course, the child also developed a seizure disorder.

Ultimately, the government concession read:

In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii).

In other words, Kirby's wrong when he implies that the government conceded that vaccines cause autism, and the ever-excitable Kent Heckenlively is totally wrong when he out and out says it. All the government conceded was that it is more likely than not (remember the "50% and a feather" rule) that vaccines aggravated an underlying mitochondrial disorder (almost certainly genetic) that manifested itself as a regressive encephalopathy that had features of ASD. Also remember the purpose of the VICP. It is not to determine whether or not vaccines cause autism; it is to compensate families whose children were injured by vaccines, regardless of what the specific injury is.

I had contemplated marching dutifully through all nine of Kirby's questions but decided that it would be an exercise in futility. The reason is that Kirby's article is nothing more than one huge moving of the goalposts buried under his characteristic clever verbiage. Indeed, it's evidence of just how far the mercury militia has fallen and the claims of the antivaccinationists regarding vaccines and autism have shrunk from its days less than three years ago when it was being confidently stated by David Kirby and friends that mercury in vaccines is the One True Cause of autism. Let's remember what the full title of Kirby's book was: Evidence of Harm: Mercury in Vaccines and the Autism Epidemic, a Medical Controversy, not Evidence of Harm: Vaccines Aggravating a Rare Preexisting Genetic Mitochondrial Disorder and Causing a Condition That Mimicks Autism. As for the rest of the mercury militia, J.B. Handley's Generation Rescue used to say with utter confidence that "childhood neurological disorders such as autism, Asperger's, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning." It then shifted the goalposts to say, "We believe these neurological disorders ("NDs") are environmental illnesses caused by an overload of heavy metals, live viruses, and bacteria." Now he's crowing in the comments of Age of Autism that this ruling is the "single largest bombshell in the history of the vaccine-autism fight."

Let's see. The court ruled that a child with a rare mitochondrial disorder may have been injured by vaccines with, among other consequences, and encephalopathy that resembles ASD, a case that's likely to apply to a very small number of children, and J.B. Handley is gloating about how it is such a huge bombshell? Here's a hint: The court did not rule that vaccines cause autism. As for the ever-loquacious David Kirby, if you want to get an idea of how much he has moved the goal posts and isobfuscating what is likely the true import of this ruling, you only have to check out some of his own article:

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."

It's difficult not to note that the child in the concession had not just immunizations, but a history of multiple infections. Another example of Kirby's obfuscatory prestidigitation:

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?

Except that this vaccine "injury" didn't manifest itself as autism, at least not the classic common variety that has been increasingly diagnosed since the early 1990s.

More amusing and also annoying is how, after Kirby admits that mitochondrial disorders are "rare in the general population, affecting some 2 in 10,000 people), he goes on to do what he would probably call a thought experiment but what I would tend to call "making shit up" in which he speculates about how many children with autism or ASDs have mitochondrial disorders. Of course, the articles that he cites do not support the implication behind his other speculations that these mitochondrial diseases plus vaccines lead to autism, nor does his pointing out that dubious biomedical interventions for autism resemble interventions for mitochondrial disease support his obvious implication that there must be something to these "treatments." Finally, as Kristina Chew so astutely points out, this article is also nothing more than another example of David Kirby's trying to redefine autism so that he doesn't have to admit that his "great" accomplishment, the book that made him a god among the antivaccinationists, is looking increasingly ridiculous in light of several studies failing to find the strong link between vaccines and autism claimed by the mercury militia, antivaccinationists, and their apologist, David Kirby:

From here, Kirby posts his nine questions, suggestively speculating that there might be a connection among "vaccines, mitochondrial disorders and a diagnosis of autism, at least in some cases" and going so far as to suggest that some type of "vaccine aggravated mitochondrial disorder" is "mimicking" autism--just as, a year ago, Kirby speculated that what we call "autism" in children with various gastrointestinal symtoms is not "autism," but (Kirby's neologism) "Environmentally-acquired Neuroimmune Disorder" or "E.N.D.."

It is no surprise that Kirby keeps on making up elaborate names for some disease "mimicking" autism: I've read his book and numerous essays and blog posts and interviews, and each time am left with the sense that he indeed is not talking about autism. Kirby's writings are packed with scientific references and just enough jargon, with a kindly phrase interwoven to acknowledge the suffering of those with autism and of those who take care of him. But I remain hard-pressed to find an actual reference, a basic description, of an autistic person in his writing, beyond (on and off last year) rather purplish descriptions of rivers of diarrhea spewn forth on carpets.

One thing that you should remember about Kirby's pretty rhetorical flourishes and speculation. It's all there to distract you from the utter failure of science to support the original claims of the mercury militia, namely that mercury in vaccines was the cause for most cases of autism, or, as Generation Rescue puts it, that autism is a "misdiagnosis for mercury poisoning." Multiple large and well-designed epidemiological studies have utterly failed to find a link between mercury in vaccines or vaccines in general and autism. Indeed, the idea that vaccines cause autism is the incredible shrinking hypothesis. It's gone from confident claims that mercury or vaccines cause nearly all cases of autism to a lot of handwaving based on one case conceded by the government in which the plaintiff had a rare mitochondrial disease which may have been aggravated by vaccines plus multiple bouts of inflammation due to otitis media, a far cry from previous cries blaming vaccines for an "autism tsunami." Is it possible that in rare cases vaccines can aggravate a preexisting condition and lead to injury that resembles autism or ASD? Despite all the studies cited by Kirby in is speculations, what we really have is one documented case of a child in which childhood vaccines probably exacerbated a preexisting mitochondrial disease who later went on to meet the diagnostic criteria for mild autism; so it's possible. It's also a far cry from the original claims of the mercury militia. Don't forget that. Also don't forget that, no matter what new physiologic alterations or abnormalities are found in autistic children, antivaccinationists always--and I mean always--manage to find a rationale to link it to vaccines, no matter how tortured that rationale is.

Once again, it really is all about the vaccines, not finding the cause of autism and ways to ameliorate the cognitive problems associated with it.

Finally, if you're still not convinced and think that this concession means that the government is really admitting that vaccines cause autism, ask yourself this simple question: If this case conceded by the government is such a slam-dunk piece of evidence that mercury in vaccines or vaccines themselves cause autism, why on earth did the plaintiff's allow it to be dropped from the Autism Omnibus and settled? If, as Kirby implies and Handley and Heckenlively outright state, this case is slam-dunk, irrefutable evidence that vaccines cause autism so strong that the government couldn't fight it, then keeping it in the Autism Omnibus as a test case would have allowed it to serve as a precedent that would provide a significant proportion, if not all, of the plaintiffs of the nearly 5,000 cases to follow a much better chance of obtaining compensatio? If this case is so damning, as Kirby et al imply that it is, would dropping it from the Autism Omnibus make any sense?

Maybe David Kirby or one of the other antivaccinationists crowing over this concession by the government can explain that one to me.

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I was discussing this today with a guy who has worked in the public-health field for decades. He's just utterly horrified that this should even be an issue.

What I think has happened is that a new thing has started in autism, like so many times before. It's like thimerosal all over again. This time, however, it looks more scientific and plausible than usual, and rare enough to be rationally conceivable.

Some things will change, no doubt. Alt treatments for autism will shift so they are more like treatments for Mito disorder. Chelation will fall out of favor to a large extent, and low-carb diets and vitamin supplements will take its place (though these treatments are already fairly popular.)

We just need to watch the science in the following years and see what comes out of it, if anything. What exists now is certainly not enough to make the sorts of proclamations Kirby and Handley are making.

The Mercury/Autism believers claim loudly that autism is NOT a genetic condition (because they want a _cure_, and genetic conditions don't lend themselves to easy cures), but simultaneously claim that autistic kids suffer from "mercury efflux disorder", which might very well be of genetic origin, according to them, based on no data.

There's a huge disconnect gap. They would be willing to blame genes, but only if they can blame vaccines too.

Excellent post Orac. Thank you for taking the time to wade through Kirby's stinking pile of nonsense.

I do expect that there will now be a sudden uptick in the number of mitichondrial disorders within the ASD population. The HBOT zealots have already included mito disorders as part of the rationale for hyperbaric treatment for all autistic children.

Don't expect anyone to ever admit that it was never the mercury or measles. More likely they'll try to roll that up in the grand unifying theory of vaccine induced mitochondrial autistic disorders.

By notmercury (not verified) on 28 Feb 2008 #permalink

I wouldn't mind if it was just nutters like him, but even the mainstream media are still trying to create a controversy out of nothing (i.e. our infamous Daily Mail http://www.layscience.net/?q=node/29). The out and out quacks can be dealt with, but the subtle "creep" of anti-vaccination propaganda is hard to even spot at times.

Nicely done. I wish Kirby would go hide under a rock somewhere. Unfortunately for us he's making zillions by selling his crap book through TACA, ARI, and other quack autism organization.

That is some level of denial, isn't it.

I wonder, has anyone ever done any studies as to a correlation between autism and the fraction of toys imported from China? After all the news last year of contaminated toys, it just started me to wondering . . .

Mitochondrion- Millions of years of known toxicity! (Unsafe at any Concentration)

By notmercury (not verified) on 28 Feb 2008 #permalink

My Enquiring Mind wants to know:

If mercury causes autism, why didn't my generation (boomers) -- and our parents' and grandparents' -- have a raging epidemic of autism? Every time we skinned our knees, our moms would slop merthiolate (AKA "red sting-y stuff") all over it and sometimes top things off with a mercurochrome-pad Band-Aid. Not to mention that we all got dosed with Ceiling Cat only knows how much mercury every time we got a shot!

We now return you to your regularly scheduled out-of-touch-with-reality state already in progress.

By themadlolscientist (not verified) on 28 Feb 2008 #permalink

A masterful summation Orac and I thank-you for it.

Right, mercurochrome! I remember, each time I had a blister in my mouth (and that was not so rare), I got a dose of mercurochrome! Right into the bloodstream! And that was in the seventies, so where is the epidemic?

Hey, this stuff is T+. Who would have thought...

Thank you for responding to the nonsense coming from the Clowns of Autism blog and Kirby.

The anitvax ambulance chasers have know that this child has had this experience for some time. The ambulance chasers may have had her file and all the details on her (including the dx for a mitochondrial disorder) for a few years now (they've been dragging out the Omniubs thing for what is it? five years, I think.)

So in that time they should have been able to find a percentage of their clients with the same issues, and they could have created a subgroup: "Autistic kids who have mito disorders and fall into the abyss of autism after a vaccine of any sort." Instead they created three sub-groups: "MMR did it" "Thimerosal did it" and "Both MMR and thimerosal did it." They tried to shoe-horn this child into the "thimerosal did it" group, but she didn't fit there. Because it looks like the weakened chickenpox virus did it, if it's true that a vaccine had any effect on what happened to her at all in the big picture.

So if her case was typical of autism where are all the others like her. Surely the sharks could come up with 10 more like her out of the thousands of cases they have at their disposal.

Then it's odd that no one on the EoHam Yahoo! group has rushed forward with "MY WORD! I'm not a litigant, but that sounds exactly like what happened to MY Benjie!!!" And does Handley have one of these mito kids? Apparently not. Does Lenny Schafer? Apparently not, it looks like his adopted son wasn't vaccinated at all so his case doesn't fit so well.

And if the antivaxers want to make a poster child out of this girl, and she's particularly vulnerable to viruses and vaccines and all, how is it that she had no problem with her earlier vaccines?

And how come the big story that so many cases of autism are really mitochondrial disorders was "broken" by the third rate reporter Kirby instead of by one of the genius, "Brave Maverick Doctors" of DAN!? I have heard them painted as the most incredibly insightful uber-physicians, but where is the mention of mitochondrial disorders being the thing in the DAN! consensus? How come there aren't 5 different talks on the wonders of curing specific kinds of mitochondrial disorders on tap for the next Autism One conference? Now there might some quacks who will start claiming to have cures for imaginary "mito" problems, but how come they haven't been on this already? I think that it looks like DAN! was caught with their pants down.

"The way the Autism Omnibus proceedings are set up is to make the bar that the plaintiffs must jump with the evidence quite low, specifically on the legal standard of plausibility, which in essence means '51% probability,' or, as one lawyer for the families called the standard '50% and a feather.'"

One old, repetitive comment and one new one:

Old, repetitive comment - The "50% and a feather" burden of proof on the claimants doesn't differentiate the Autism Omnibus from most U.S. civil court cases. What does differentiate it is that most civil court cases adhere to the so-called Daubert standard of scientific evidence, where whether the trier of fact (judge or jury) gets to see a report or article may very well depend on independent indicators of validity such as peer review. In the Omnibus cases, reports and articles may be submitted into evidence even without such independent indications of reliability as peer review. This doesn't mean such evidence is entitled to any credence; it simply means that it's there to be considered by the triers of fact for whatever it is worth. Which brings me to my second point...

New comment - "50% and a feather" should not be compared to, e.g., the degree of correlation usually considered necessary for scientific proof. What "50% and a feather" means is that once the trier of fact has evaluated the evidence for scientific validity (almost always guided by the testimony of experts regarding the criteria for establishing scientific validity in a particular field), one side will be determined to have brought forward more scientifically valid evidence than the other. So "50% and a feather" is a qualitative as well as a quantitative measure.

Think of a football game - one team can pile up a lot more yardage than the other, but what matters is the "quality" of the yardage, i.e., the final score. Analogous to "50% and a feather," even if Team A outscores Team B by only a single point, Team A is victorious.

ORAC completely misses the point. This was no 50/50 case.

The government were going down badly so they did damage limitation and conceded it with a secrecy gag to stop anyone finding out.

And they have been claiming for years vaccines do not cause autism, and suddenly we find the are admitting this is possible. So possible they threw their hand in in this case.

And something else ORAC fails to take on board. For year the parents have been saying examine our kids clinically case by case, and hey presto, here is a kid examined clinically and what do we find, the government agrees the kid's autism was caused by vaccines.

And how many other cases are there that have been quietly fixed so no one finds out, huh?

And what would happen if all kids got a fair chance and were properly and clinically examined and the right tests and studies carried out?

But of course ORAC just cain't accept defeat on anything and so undermines all other arguments.

By David Wright (not verified) on 29 Feb 2008 #permalink

For year the parents have
been saying examine our kids clinically case by case, and hey presto, here
is a kid examined clinically and what do we find, the government agrees the
kid's autism was caused by vaccines.

No, that's not what the government said. Read my post again and then read Steve Novella's take on the issue.

Thanks a lot for blogging on this. I went and read Dr. Novella's post as well, and that cleared up a lot of Kirby's woo for me. When I read Kirby's article, I was thinking "he isn't really saying what I think he's saying" without really being able to articulate what I thought was wrong, but Novella really spells it out - that Kirby has this strange misconception that a toxin from a vaccine can cause the same single-point mutation in the mitochondria of all the cell lines of a child that has gotten a vaccine. And that is just silly on it's face, if you understand anything about embryology, to start with.

For year the parents have been saying examine our kids clinically case by case, and hey presto, here is a kid examined clinically and what do we find, the government agrees the kid's autism was caused by vaccines.

What some parents have been saying for years is that 25 micrograms of thimerosal can cause autism. Actually, they have said that is THE cause of autism. I'm at a loss as to what that has to do with regressive encephalopathy due to infections in mitochondrial disorder. So parents have been saying "this thing about vaccines cause autism", and we're supposed to think they were right all along because one child might have had a vaccine reaction of some other sort that led to a diagnosis of ASD? It's as if the hypothesis and the mechanism are simply afterthoughts, so long as the blame can be placed on vaccines (or something the government did).

Ms. Clark is absolutely right. How in the world did DAN! miss the boat on this one? Have they ever mentioned this as a possible mechanism? I guess it's not a sexy hypothesis. Mito disorder is typically genetic, very rare, and often fatal.

ORAC, this is about child health safety. You pretend there is a religion called "anti-vaccine". Way off base buddy.

You are anti-child health safety. Instead of calling for emergency measures to find out what has happened to all the other kids, ORAC buries his/her/its head in the sand and in effect says - "I'm gonna let them all continue suffering - I'd rather do that than do something to find out what has happened to all the others".

And you don't answer the other points either do you? Like the big one - they have told us for years there was no link and yet here they agree not just a link but the BIG BIG ISSUE - the vaccines caused the autism. Yep, that is what they agree and it is what you have been claiming for years is false - so now we find out it is true. ORAC's credibility hits the pan. Well done ORAC. So what else have you been telling us that is bunk - aside from all the times when you have no answer but instead attack people personally when the facts are not on your side.

Now why do you think they called "Generation Rescue" just that. The one thing these kids need is rescue - but don't worry - ORAC knows - knows how to bury the head in the sand and keep it there. ORAC is down to trench warfare - hand-to-hand fighting over this case and each and every other case. Oh, dear, ORAC. Isn't it so much easier to rely on epidemiolgy from people like Fombonne so you can dismiss all the individual clincal cases with one big messy broad brush.

The government experts agreed the following facts. It is a similar story for millions of others around the world.

"At the July 19, 2000 examination, CHILD received five vaccinations - DTaP, Hib, MMR, Varivax, and IPV. Id. at 2, 11."

"According to her mother's affidavit, CHILD developed a fever of 102.3 degrees two days after her immunizations and was lethargic, irritable, and cried for long periods of time. Pet. Ex. 2 at 6. She exhibited intermittent, high-pitched screaming and a decreased response to stimuli. Id. MOM spoke with the pediatrician, who told her that CHILD was having a normal reaction to her immunizations. Id. According to CHILD's mother, this behavior continued over the next ten days, and CHILD also began to arch her back when she cried. Id."

These facts are so soooo similar to so so very many other children. You try to fob it off. So what about all the others ORAC?

Stop being anti-scientific - you don't know because no one has looked at these kids individually and clinically like this one kid. Up to now the government has refused to do anything other than rely on flawed statistical studies instead of individual clinical cases. That is because they know what they will find and have buried their heads in the sand just like you.

And as you still won't accept it in this case you won't accept it in others.

And let's see what else ORAC cannot answer:-
- this was no 50/50 case. The government were going down
badly so they did damage limitation and conceded it to try to stop anyone finding out.
- and they have been claiming for years vaccines do not cause autism, and suddenly we find the are admitting this is possible. So possible they threw their hand in in this case.
- for years the parents have been saying examine our kids clinically case by case, and hey presto, here is a kid examined clinically and what do we find, the government agrees the kid's autism was caused by vaccines
- and how many other cases are there that have been quietly fixed so no one finds out, huh?
- and what would happen if all kids got a fair chance and were properly and clinically examined and the right tests and studies carried out?

But of course as I said, ORAC just cain't accept defeat on anything and so undermines all other arguments.

By David Wright (not verified) on 29 Feb 2008 #permalink

David Wright, please come join us in the reality-based community. It's actually quite nice here.

This case does not mean that vaccines cause autism, no matter what David Kirby and the mercury moms might like to think. It is precisely BECAUSE the case does not support this belief that it had to be removed from the Autism Omnibus. If it were a winner, they would have kept it in there.

I didn't realize that New York Met star David Wright felt so passionately about opposing life-saving vaccines. I am not surprised, though, that a baseball player would know nothing about science OR law.

By anonimouse (not verified) on 29 Feb 2008 #permalink

"isles" claims above (Mar 1 12:07am) that "This case does not mean that vaccines cause autism".

Really? Wot "isles", lost your eye glasses have you?

This is what the decision of the Court said:-

"ANALYSIS
Medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC) have reviewed the facts of this case, as presented by the petition, medical records, and affidavits. After a thorough review, DVIC has concluded that compensation is appropriate in this case.

In sum, ....... the vaccinations CHILD received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder."

So ORAC, So "isles" - you don't care about child health safety. You just want to prop up greedy needle happy drug companies. If you did care about child health safety you would be calling for urgent investigations into all the other kids to find out how the vaccines caused their autism too.

And if you really did believe that vaccines are so important, you would be calling for this even louder than anyone else.

Funny that? The silence on these critical issues from ORAC the oracle who knows (not) and his/her/its hangers on like "isles".

By David Wright (not verified) on 29 Feb 2008 #permalink

Nowhere in the decision does it say that vaccines cause autism. Nor could such a scientific determination be made in a court decision. I'm not sure how it is that people are parsing that meaning into the decision.

When people claim that "vaccines cause autism" they generally mean that a sizable portion of all autism cases are caused by vaccines, that vaccines are responsible for an imaginary "epidemic" of autism, and so forth. The decision has to do with one child only, so it cannot be assumed to imply general causation.

The Omnibus is about thimerosal and MMR. It's quite obvious why the case was taken out. The same case cannot possibly be won if it's argued that thimerosal or measles caused the child's regression. There just isn't sufficient evidence to demonstrate such specific claims. Whereas the Mito disorder explanation is quite plausible and the circumstantial evidence is good.

Now, I'm sure the other test cases in the Omnibus have had thorough clinical examinations. So I'm not sure what the complaint is about that.

And of course the circumstances around this case should be studied further. It will be important to know what relationship, if any, exists between Mito disorder and autism, how common it is, whether there's a true causal relationship in such cases, and so forth. Researchers will work on those questions no doubt.

Joseph is living in dreamland.

The US government filed this official document in court intentionally to concede that the vaccines caused the child's autistic symptoms. The damages are being paid for vaccine damage caused by the vaccines under law specifically provided for that purpose.

But Joseph wants to pretend that is not true. He wants to pretend the child has no symptoms of autism, despite the clear wording of the US government's admission. He wants to pretend that vaccines can never cause children to exhibit symptoms of autism. He does not want to admit the possibility that the vaccines can cause autism in some children.

That makes Joseph an enemy child health safety, because he does not want to admit the possibility. It is living in denial, just like ORAC. And that denial is causing more and more children to be damaged and their health to be damaged.

If he was concerned about the health and safety of children, he would be calling for urgent clinical investigations of all these children - and if he believes the vaccines are so important, he should be shouting the loudest. But instead he is not.

His argument is the same a saying that guns don't kill people - its really only the person who pulls the trigger.

It is like arguing that because there are a variety of factors which were together present that "caused" the autism, it was not the vaccines. The US government does not concur with Joseph.

Wholly disingenous argument. Going by his reckoning, the child's autism was caused by being human, a genetic organism, American, too young and whatever else, but not because the child had the vaccines.

It is a nonsense argument. It is dissembling. This shows the lengths ORAC and ORAC's disciples go to to avoid plain and obvious facts. This demonstrates they will argue the equivalent of the moon being made of green cheese if they have to.

By David Wright (not verified) on 01 Mar 2008 #permalink

The government were going down badly so they did damage limitation and conceded it with a secrecy gag to stop anyone finding out.

Mr. Wright, "the government" hasn't imposed a "secrecy gag to stop anyone finding out." The court is complying with the regulatory requirement to protect the confidentiality of VICP petitioners' medical information. The only reason that the Cedillo, Hazelhurst and Snyder hearing transcripts have been made publicly available was that the petitioners explicitly requested it. Even then, you can't go browsing through all the filings in those cases designated as "test cases" except those documents that have been filed to the public OAP docket.
http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm

Here's the relevant portion of the Vaccine Rules.
http://www.uscfc.uscourts.gov/OSM/Vaccine%20Rules.pdf

***

Rule 18. Availability of Filings

(a) General. All filings with the clerk pursuant to the Vaccine Rules are to be made available only to the special master, judge, and parties, with the exception of certain court-produced documents as set forth in subdivision (b) of this rule.

(b) Decisions of Special Masters and Judges. When a decision of a special master or of the court is filed with the clerk, each party will be afforded 14 days in which to object to the public disclosure of any information furnished by that party

(1) that is trade secret or commercial or financial in substance and is privileged or confidential; or

(2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy. If the party furnishing information objects to disclosure, that information shall be redacted prior to public disclosure of the decision. In the absence of an objection, the entire decision will be made public.

***

Medical records and medical reports filed with the court in civil cases are available for public review unless the parties request that access be restricted. Such a request is generally granted if the information falls into one of the categories described above. For example, the plaintiffs in Doe v. Ortho-Clinical Diagnostics (the ill-fated RhoGAM-causes-autism case) requested that their names be redacted from publicly-available documents, and the medical filings are only available to the court and the parties to the case. In contrast, the plaintiff in Redfoot v. Ascher (the ill-fated nasal-spray-causes-autism case) did not make such a request, so all of those case filings are publicly available -- including all sorts of material of an extremely personal nature.

VICP administrative proceedings are different. Along with allowing for more relaxed standards of proof and admissibility of evidence than in civil proceedings, the program allows for greater protection of petitioners' privacy.

There is no nefarious cover-up. This is how the system is supposed to work.

Kathleen Seidel,

You have it wrapped around your neck big time.

Are you trying to tell everyone that the US government did not know the papers have a secrecy gag when they filed their concession and did not realise no one would know about it?

Did they issue a press release and tell everyone this important news that they were admitting the vaccines cause kids to get symptoms of autism?

What's that Kathy? I can't quite hear you?

No? Oh, so they did not issue a big fat press release and tell everyone? So Kathy, that sounds like they were relying on a secrecy gag doesn't it?

Tough Kathy. You lucked out this time. And we can see what you are up to.

Instead of answering the points made, you raise a complete irrelevance to distract from the real issues. In doing so you want to try to make it look like a critic of your cause is wrong, so as to make it look like all else they are saying is wrong.

You are living in dreamland. And what you also prove is that you use the same old tricks to distract people.

If you were concerned about the health and safety of children, you would be calling for urgent clinical investigations of all these children - and if you believe the vaccines are so important, you should be shouting the loudest. But instead you are not.

By David Wright (not verified) on 01 Mar 2008 #permalink

David Wright wrote "It is a nonsense argument. It is dissembling. This shows the lengths ORAC and ORAC's disciples go to to avoid plain and obvious facts. This demonstrates they will argue the equivalent of the moon being made of green cheese if they have to."

As a parent of a child who was injured due to a now vaccine preventable disease, I am curious as to what facts you actually have.

Could you show us the research (include title, author, data, which journal) that explicitly shows which vaccines in the present pediatric schedule are more dangerous than the actual disease. For instance show the data that getting the now thimerosal free DTaP is more dangerous than getting diphtheria, tetanus or pertussis, or that getting the MMR (which has been in use in the USA since 1971 and has never contained thimerosal) is more dangerous than getting measles, mumps or rubella, or that getting the Hib vaccine is more dangerous than getting Hib (that is a more recent vaccine, I met a mom who would have had a child the same age as my oldest, except he died from Hib).

For an example of the quality of evidence try this:
http://archpedi.ama-assn.org/cgi/content/full/160/3/302

After all, the real issue is the overall health of children, and preventing things that cause neurological damage... like the seizures my son had while during a now vaccine preventable disease. So show us your actual facts.

But Joseph wants to pretend that is not true. He wants to pretend the child has no symptoms of autism, despite the clear wording of the US government's admission. He wants to pretend that vaccines can never cause children to exhibit symptoms of autism. He does not want to admit the possibility that the vaccines can cause autism in some children.

Do not misrepresent me. I hate that. I have never said the child didn't have symptoms of autism. In fact, elsewhere I said that the child meeting criteria for ASD means the child is autistic, period.

Could vaccines conceivably cause autism in some children? Sure. Where did I say that's not possible under any circumstances? It was, in fact, well known before this that rare instances of neurological damage from vaccines exist. Is it possible for neurological damage to manifest as autism? Sure, why not.

Does the case prove a child was made autistic by vaccines in this instance? No. But there's good circumstantial evidence.

If he was concerned about the health and safety of children, he would be calling for urgent clinical investigations of all these children - and if he believes the vaccines are so important, he should be shouting the loudest. But instead he is not.

Didn't I basically do that in my prior message? Of course the children are going to be investigated. In fact, autistic children are investigated all the time. Ever heard of PubMed? There are hundreds of clinical studies on autism every year. Only in conspiracy-land would someone believe researchers are purpusefully avoiding the clinical study of autistic children. My sense, David, is that you don't care so much about clinical findings in autism, but only whether vaccines are determined to be a cause of autism. If a cause of autism were found to be something else (e.g. minicolumnopathy) I seriously don't believe you'd be very excited.

Instead of answering the points made, you raise a complete irrelevance to distract from the real issues.

No, I addressed a single point you made, and left the remainder for others to address.

Now I will address one other point. The VICP Office of Special Masters doesn't generally issue a "big fat press release" announcing the disposition of a claim. The Vaccine Program is part of an administrative agency, not a PR firm. Once all medical records and affidavits have been submitted and hearings (if any) have been held, the Special Master assigned to the case issues an official order setting forth his or her decision. That order is then posted on the U.S. Court of Federal Claims website, in compliance with the E-Government Act of 2002. VICP decisions are linked from http://www.uscfc.uscourts.gov/OSMPage.htm; follow the links in the left column to "Published Decisions" (i.e., precedential decisions with applicability beyond the immediate case) and "Unpublished Decisions." You can also gain access to precedential decisions via Lexis and Westlaw, and via the hard-copy Federal Claims Reporter. Eventually, official orders will be issued for every case in the OAP, as each claim is resolved -- but not before.

I think that causation was conceded in this case because the child had encephalopathy, which is a table injury as to which causation is presumed. There is no requirement that the petitioner's encephalopathy cause "autistic features," but the petitioner is required to show both acute and chronic encephalopathy. According to the aids to interpretation of the vaccine injury table, "[c]hronic encephalopathy occurs when a change in mental or neurologic status, first manifested during the applicable time period, persists for a period of at least 6 months from the date of vaccination." I think the child's developmental problems met this requirement, but changes in mental or neurologic status would not have to be equivalent to "autistic features."

As you can see from the vaccine injury table, causation will be presumed if encephalopathy occurs after a DTaP vaccination or an MMR vaccination, both of which this child had in July of 2000. My reading of the Rule 4(c) report, in which the respondent says that "the facts of this case meet the statutory criteria for demonstrating the the vaccinations ... significantly aggravated an underlying mitochondrial disorder, which ... manifested as a regressive encephalopathy ..." is that the child suffered the table injury of encephalopathy, and causation is presumed. Since there appears to be no evidence to rebut the presumption by showing that the encephalopathy resulted from a non-vaccine cause, it was proper for the Department of Health and Human Services to make this concession.

- and how many other cases are there that have been quietly fixed so no one finds out, huh?

If you want to know, the Court of Federal Claims makes the stipulations available in the unpublished decisions of the special masters. You can view them here - just look for the cases with stipulations. Some of the stipulations settle contested cases, while others involve cases, like this one, where there is no contest.

Joseph, Anne...

Please review your implicit assumption that Mr. Wrong is arguing in good faith rather than metaphorically masturbating in public, and check it against the available evidence.

I really don't understand these anti-vax types. I don't think they'll be happy until all vaccines are suspended, at which point, within a few years, thousands of children will start dying of diseases formerly kept well in check. I sometimes doubt that even those deaths will convince them of the misguidedness of their cause.

Ipecac, Orac and others,

Why do you place all parents of vaccine-injured children into a camp you call "anti-vaccination". I have 4 children... one who is vaccine-injured.

I'm the mom! I SAW the injury to my son with my own eyes. I am not a scientist. But it is what it is with my son... a series of vaccines changed his life FOREVER!

Instead of spending all of your energy bashing and name calling parents who are devastated or scientists who are trying to find the reason for autism appearing after a series of vaccination... spend this negative energy in helping the people who have been injured find the answer...

My child recieved a series of vaccines at 9 months... was sick and cried for days... could no longer sit up, crawl, make eye contact and started having seizures... What else would a normal parent think caused this???

Do you think your mudslinging makes me listen to you? You actually make me sick to my stomach... perhaps it is the power of suggestion from the name "Ipecac"...

Again, please help find out what is causing autims... oh, and on the side, could you also use your fondness for writing to convince the pharmaceutical companies to leave out the JUNK in producing vaccines???

Laura,

If you're interested in finding the cause of autism, then drop the anti-vaccine cause. There is NO evidence that vaccines cause autism. Every study conducted has failed to show a connection. You say you're no scientist. Why don't you try listening to actual scientists? Your misdirected anger and grief are endangering other children.

The end result of the anti-vaccination movement's success would be to bring DEATH to thousands, if not millions of children world-wide. Vaccinations stop diseases like smallpox, polio, and measles. In communities where the number of vaccinations dropped, the number of DEATHS increased.

I have a great deal of sympathy for any parent whose child has health issues. But when you want to interfere with a proven, life-saving medical technology, endangering other people's children, you've gone too far.

Laura whined "I'm the mom! I SAW the injury to my son with my own eyes. I am not a scientist. But it is what it is with my son... a series of vaccines changed his life FOREVER"

I am also a mom... but I saw the injury to my son from an actual disease!!! What am I supposed to do, bow to those of you who obliquely claim a vaccine caused seizures, when my son had seizures from a disease that I was also experiencing at the same time?

To add to that, his first seizures were when he was a newborn (it was in 1988, long before the HepB vaccine, so don't even try that worn out "logic"). Some times stuff just happens. Just like what happened to Roald Dahl's oldest daughter or what happened to William Shakespeare's son.... or to most of Mary Shelley's children.

Give it a break. Use real science. I am only an engineer, not a scientist. But at least I have just enough education to not try to associate unrelated events.

Laura: My child recieved a series of vaccines at 9 months... was sick and cried for days... could no longer sit up, crawl, make eye contact and started having seizures... What else would a normal parent think caused this???

There are vaccine related illnesses and this may be your child's diagnosis. I don't know your child's diagnosis.

If you are using your observation however, as the reason you know the vaccine caused your child's illness, that is a problem. If I diagnosed an illness by picking the last thing that happened before onset of symptoms or if I diagnosed a child's illness based on the one thing a parent believed was different, I would rarely make the correct diagnosis.

People sometimes find this hard to believe. They saw it themselves. You may have, but two things occurring in sequence like you describe simply is not proof the vaccine was the cause.

Again, I don't know your child's diagnosis. But we give a lot of vaccines to kids. They get them at birth, 2 mo., 4 mo., 6 mo., 15 mo., 18 mo., and 4-5 years of age. And we vaccinate millions of children. Some children develop illnesses, get infections, have genetic problems show up and these occur in the first few years of life.

By chance alone, many many many kids are going to develop symptoms of things just after vaccines were given and the vaccines are going to have absolutely nothing to do with the vast majority of those cases. It is inevitable. It is common. These are coincidences.

And your child could have had a known side effect, the inconsolable crying after a DPT, for example, but that may not be related to the other symptoms or diagnosis.

We can use the science of epidemiology to determine which illnesses or symptoms are possible or likely to be related to a vaccine and which aren't. If you look at a big enough sample size, you can find vaccine side effects that are as rare as 1 case in 10 million vaccine doses, or even more rare than that though we don't look at such large sample sizes for all vaccines. We have looked at large samples for influenza vaccine and the common older vaccines like DPT and MMRs and polio vaccine.

http://pediatrics.aappublications.org/cgi/content/full/106/4/e51

"The IOM found that: 1) the evidence was consistent with a causal relation between DTP vaccine and acute encephalopathy, chronic encephalopathy (as a sequela of acute encephalopathy), and hypotonic-hyporesponsive episode; and 2) the evidence indicated a causal relation for anaphylaxis and protracted inconsolable crying.5 However, decreasing numbers of these specific events reviewed by the IOM do not explain the bulk of the decreases in the numbers of serious reports, because the proportions of specific serious events reported for acellular and whole-cell pertussis vaccines were broadly similar "

What that study found was the rates of these events went down, but in kids still getting DPTs. If the DPT was causing all the events, then one might have seen a decrease in events with the newer vaccine, DTaP, or the rate could have stayed the same meaning the whole cell pertussis vaccine was not the problem vaccine. But neither of those occurred. The rate of these events went down and it isn't clear then if the vaccine was causing all the events. Something else changed.

The researchers have considered a couple possibilities.

"It is possible that the reputation of acellular pertussis vaccines for enhanced safety compared with whole-cell vaccines could result in reporting bias by affecting perceptions of health care providers and by affecting reports as to whether a particular event was life-threatening or merited hospitalization. Similarly, it is possible that in some cases, coincidental illnesses occurring in temporal association with vaccination might be more likely to be reported for whole-cell than for acellular pertussis vaccines, or that the constitutional symptoms associated with whole-cell vaccines might, in the setting of a concomitant illness, cause that illness to be considered more serious than it otherwise would. It is also possible that adverse events that in the setting of a clinical trial would be considered less serious (such as fever with prolonged crying) might in a nonclinical trial setting result in hospitalization. Because these adverse events are more common for the whole-cell than for the acellular vaccine, serious reports to VAERS would be more likely for the whole-cell vaccine."

What I am trying to show you here is that knowing for certain a vaccine did or did not cause an illness is not a simple matter of observing the timing of onset of symptoms. And I apologize if there is more to how you know your child's diagnosis. I am not questioning your claim, just the part where you believe your observation is enough to make the diagnosis, if that is what you believe.

That you have described your experience does not make you an anti-vaccine campaigner. I don't see any other posts than the one here. So what makes you feel you are being included as an anti-vaxer?

By Skeptigirl (not verified) on 08 Mar 2008 #permalink