"Just when I thought I was out... they pull me back in."
At least, that's what Michael Corleone said in The Godfather, Part 3, and even though I'm not a mafia don, I can sort of relate to where he's coming from, if you know what I mean. It seems that whenever I try to get away from blogging about the nigh infinite level of stupidity and pseudoscience that emanates from the disease promotion movement (i.e., the antivaccine movement), it seems as though they somehow find a way to pull me back in. Of course, I'd rather like to think of myself as the reluctant gunslinger pulled out of retirement for one more battle.
Either that, or certain people in the antivaccine movement twist science, logic, reason, and reality so much that they piss me off.
Certainly, such a description applies to the chief macher of the antivaccine movement these days, Jenny McCarthy and "her" autism organization, Generation Rescue, willingly given up to her Googleness by former ruler J. B. Handley. Of course, the recent twin blows of the revelations about hero to the antivaccine movement Andrew Wakefield's scientific fraud and the resounding repudiation of the first three test cases in the Autism Omnibus proceeding have drive the antivaccine movement a bit crazy. Normal people, faced with such an unrelenting stream of scientific and other evidence strongly refuting their beliefs, would start to think that maybe their beliefs need readjusting. Not Generation Rescue. The reality warp field surrounding J.B. Handley, Jenny McCarthy, and their Kool Aid drinkers is too strong. Given their cultish certainty that, no matter what the science says, it absolutely, positively has to be the vaccines causing autism, they can never retreat, never surrender, and, above all, never, ever even entertain the possibility for a minute that their most fervent belief is based on on the scientific equivalent of smoke and mirrors.
That's why I knew a counterattack had to be coming. At first, I thought that the smearing of Brian Deer and rants about the "bias" and unfairness of the Special Masters were that counterattack. But I was wrong. I should have known that the antivaccine movement knew it was in trouble and would pull out all the stops to stop the bleeding after being riddled with reports calling their world view into even more doubt than usual. I should have known that the counterattack would consist of more than just the previous feeble efforts to smear Brian Deer and blame the Special Masters' rulings on a big pharma conspiracy. I should have known that GR would resort to yet another ad in USA Today:
Then I should have known that they'd throw together the chief apologist for the antivaccine movement, along with its chief conspiracy-monger, namely David Kirby and Robert F. Kennedy, Jr., respectively. And where, you ask, would two such luminaries of the antivaccine movement ply their fallacious arguments? Where do you think? Yes, appearing Tuesday night on that repository of antivaccine lies and pseudoscience, The Huffington Post, was this gem by those two crappy tastes that taste crappy together, David Kirby and RFK, Jr., entitled Vaccine Court: Autism Debate Continues.
If stupid were a poison, all life on earth would be dead and rotting from the emanations of the two articles contained under the above link. And if stupid really did burn, the surface of the earth would consist of nothing more than charred rock, with the oceans themselves vaporized.
Let's take a look first at the article by RFK, Jr., Another Autism Case Wins in Vaccine Court. It just goes to show that RFK, Jr. is not the smart one in this pairing; he boldly lays down the stupid:
The New York Times joined the government Health Agency (HRSA) and its big pharma allies hailing the decisions as proof that the scientific doubts about vaccine safety had finally been "demolished." The US Department of Health and Human services said the rulings should "help reassure parents that vaccines do not cause autism." The Times, which has made itself a blind mouthpiece for HRSA and a leading defender of vaccine safety, joined crowing government and vaccine industry flacks applauding the decisions like giddy cheerleaders, rooting for the same court that many of these same voices viscously derided just one year ago, after Hannah Poling won compensation for her vaccine induced autism.
But last week, the parents of yet another child with autism spectrum disorder (ASD) were awarded a lump sum of more than $810,000 (plus an estimated $30-40,000 per year for autism services and care) in compensation by the Court, which ruled that the measels-mumps-rubella (MMR) vaccine had caused acute brain damage that led to his autism spectrum disorder.
Yes, it's the Hannah Poling case all over again, except this time they're not rebranding autism as a mitochondrial disorder. What they are trying to rebrand autism as again, you will see in a moment. In the meantime, let the stupid flow over you as RFK, Jr. spins and twists. The only reason I don't say that he's lying is because I've come to believe that he really, truly believes the nonsense he is spewing:
The family of 10-year-old Bailey Banks won their case quietly and without fanfare in June of 2007, but the ruling has only now come to public attention. In the remarkably clear and eloquent decision, Special Master Richard Abell ruled that the Banks had successfully demonstrated that "the MMR vaccine at issue actually caused the conditions from which Bailey suffered and continues to suffer."
Bailey's diagnosis is Pervasive Developmental Disorder -- Not Otherwise Specified (PDD-NOS) which has been recognized as an autism spectrum disorder by CDC, HRSA and the other federal health agencies since at least the 1990s.
Wow. It sure looks like ol' RFK's got all those nasty pharma shills there by the short hairs, doesn't it? I mean, it sure looks like a slam dunk, doesn't it? PDD-NOS is indeed one of the conditions that fall under the category of disorders known as autistic spectrum disorders (ASDs) and is thus considered an ASD. The ruling concluded that, in the case of Bailey Banks, the MMR had caused a condition known as acute disseminated encephalomyelitis (ADEM). Here is the passage that RFK, Jr. quotes:
The Court found that Bailey's ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey's ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD [an autism spectrum disorder]. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was... a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.
This is not an exact quote of what Special Master Richard Abell's ruling. Note the term "an autism spectrum disorder" in brackets. There's just one problem. PDD is not an autistic spectrum disorder. Let's look at the very beginning of the Special Master's ruling:
On 26 June 2002, the Petitioner filed a petition for compensation under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act or Act)2 alleging that, as a result of the MMR vaccination received on 14 March 2000, his child, Bailey, suffered a seizure and Acute Disseminated Encephalomyelitis ("ADEM"),3 which led to Pervasive Developmental Delay ("PDD"), a condition from which he continues to suffer (the "Petition").
Note the difference. The claim in the ruling is not that ADEM led to pervasive developmental disorder, not otherwise specialized (PDD-NOS). The ruling is about pervasive developmental delay (PDD). The difference is more than a matter of semantics, as Kev points out. PDD is not the same thing as PDD-NOS. In fact, the ruling itself makes this point very, very clear in one of its footnotes:
Pervasive Developmental Disorder, Not Otherwise Specified (PDD-NOS) is a 'subthreshold' condition in which some - but not all - features of autism or another explicitly identified Pervasive Developmental Disorder are identified. PDD-NOS is often incorrectly referred to as simply "PDD." The term PDD refers to the class of conditions to which autism belongs. PDD is NOT itself a diagnosis, while PDD-NOS IS a diagnosis. The term Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS; also referred to as "atypical personality development," "atypical PDD," or "atypical autism") is included in DSM-IV to encompass cases where there is marked impairment of social interaction, communication, and/or stereotyped behavior patterns or interest, but when full features for autism or another explicitly defined PDD are not met.
In fact, PDD-NOS is a subset of PDD, but there are other forms of PDD. This is what RFK, Jr. says about it:
Bailey's diagnosis is Pervasive Developmental Disorder -- Not Otherwise Specified (PDD-NOS) which has been recognized as an autism spectrum disorder by CDC, HRSA and the other federal health agencies since at least the 1990s.
No, it's not. Read the decision. Granted, the terms PDD and PDD-NOS seem to be used almost interchangeably and sloppily so, but latching on to that doesn't "prove" anything. In fact, if you read through the ruling, you'll also see that even the facts of the case do not represent the slam dunk that RFK, Jr. seems to think they do. Indeed, the Special Master even acknowledges that and feels the need to justify his decision:
Despite their accord on certain factual predicates contained in Bailey's medical records, there is, unsurprisingly, a pronounced conflict between the parties as to the following issues: whether a biologically plausible link exists between ADEM and pervasive developmental delay (PDD) in a direct chain of causation, whether Bailey did in fact suffer from ADEM, and ultimately whether the administration of the MMR vaccine to Bailey actually caused ADEM which would then cause PDD that currently besets Bailey today.
Note that Special Master Abell referred to PDD as "pervasive developmental delay." Again, I'll grant you that he seems to flip back and forth between using PDD that way and to mean PDD-NOS in a confusing manner, but once again the antivaccine fringe reads far more into it than is warranted.
As for the issue of autism, here is what Special Master Abell also admitted:
Dr. Lopez's diagnosis appears to conflict with the diagnosis given by Bailey's pediatrician on 20 May 2004, who saddled Bailey's condition with the generalized term "autism"; however, that pediatrician later acknowledged that use of the term autism was used merely as a simplification for non-medical school personnel, and that pervasive developmental delay "is the correct [i.e. technical] diagnosis." Pet Ex. 35. Another pediatrician's diagnosis noted that Bailey's condition "seems to be a global developmental delay with autistic features as opposed to an actual autistic spectrum disorder." Pet. Ex. 30 at 4
In other words, reading the entire judgment, whatever neurological disorder Bailey has, I consider it arguable whether Bailey has an ASD. He very well might have PDD-NOS; he might not. In fact, the title of the ruling should tell you how sure Special Master Abell was that the MMR caused Bailey Banks' autism: Non-autistic developmental delay; Acute Disseminated Encephalomyelitis; Expert Credibility; Evidentiary Reliability; Scientific Validity; Burden of Proof; Causation in Fact; Proximate Causation. Moreover, the chain of causality gets gets more strained when we consider ADEM. For one thing, it's not even entirely clear that he had ADEM, as the testimony in the case reveals, given the arguments, although let's say for the moment that he definitely did. Next, there's virtually no scientific literature to support the link between ADEM or PDD (or PDD-NOS, for that matter). Basically, the ruling is best read as saying that in this case MMR might have caused ADEM, which might have resulted in PDD. That's a lot different than RFK, Jr.'s confident blather that this is a slam-dunk indication that the court has accepted that vaccines can cause autism.
What I find more troubling, however, is this statement in Special Master Abell's ruling, harped on by David Kirby in his article:
In response, Respondent's expert stated that, although ADEM may result in "permanent neurological sequelae," nevertheless "all the medical literature is negative in that regard;" however, soon thereafter, he corrected this statement by clarifying, "I can find no literature relating ADEM to autism or [PDD]." Tr. at 84-85. It may be that Respondent's research reveals a dearth of evidence linking ADEM to PDD, but that is not the same as positive proof that the two are unrelated, something Respondent was unable to produce. Therefore, the statement that "all the medical literature is negative" is incorrect.
I want anyone who has claimed that the Vaccine Court is biased against the petitioners to read that paragraph again. And again. And again. That paragraph reveals a Special Master bending over backwards to give the petitioner's experts the benefit of the doubt even in the absence of any positive medical literature supporting the petitioner's hypothesis of causation for the vaccine injury claimed. (I refuse to use the word "theory.") He's even chiding the government's expert for being too particular about actually requiring some evidence published in the medical literature. Indeed, the Special Master is practically looking for a reason to reject the Respondent's defense. For the most part, this is probably a good thing. The Vaccine Court was set up to speed up and streamline the compensation process, and, given that Bailey had a reaction close enough to vaccination that the law considers it likely that the vaccination caused it legally it is probably not unreasonable that the Court decided to compensate his parents. But let's not confuse a legal ruling with science. What the Banks case appeared to boil down to was a battle of two experts, more than a dispassionate review of the science, and Banks' expert was more persuasive to the Special Master.
Curious, I did a few PubMed searches about whether ADEM can be caused by MMR. I found virtually nothing: five German articles, none newer than 1993 and British review. That's not to say that MMR can't cause ADEM (after all, other vaccines can, rarely), but the evidence is pretty spotty. This article, for instance, finds a possible association. Of course, the antivaccine movement is doing nothing other than what it did in the Hannah Poling case. RFK, Jr. and David Kirby are throwing people a big red herring. What the court admitted is that Bailey's seizures occurred soon enough after the MMR to be considered a vaccine injury and accepted that his neurologic problems could be the result. It did not "admit that vaccines cause autism" any more than it did in the Hannah Poling case. It bent over backward to give the petitioner every opportunity to come up with a concept of how vaccines might contribute to autism and argue it, primarily based on the relatively close temporal proximity. It in essence ignored testimony that there was no convincing evidence in the peer-reviewed medical literature linking ADEM to PDD. I did the PubMed searches myself, and there really isn't anything. There's no "there" there.
David Kirby, characteristically, is a bit more careful--and, of course, weaselly--about the issue. Clearly he is the smarter and cleverer of the two. What Kirby does is to throw Andrew Wakefield under the bus, metaphorically speaking, at least as far as how he claimed that MMR caused autism:
Is vaccine-induced ADEM (and similar disorders) a neurological gateway for a subset of children to go on and develop an ASD? That question will now become subject to debate. Thousands of parents have reported similar reactions and symptoms following vaccination, yet they lack radiological proof of ADEM or related disorders in the form of an MRI. Meanwhile, most children with autism do not present with myelin damage, but many do test positive for antibodies to myelin basic protein (MBP).
But what were these reactions? Kirby described them earlier:
Most cases of ADEM (80%) are in children. Symptoms usually appear within a few days to a couple of weeks. They include: headache, delirium, lethargy, seizures, stiff neck, fever, ataxia (incoordination), optic nerve damage, nausea, vomiting, weight loss, irritability and changes in mental status.
I know of thousands of parents who witnessed many of these same symptoms afflict their children shortly after vaccination, most typically the MMR. Did these children with autism also suffer initially from ADEM or some subclinical version of the disorder? We may never know (physical signs like myelin damage are transitory).
Ah, yes, yet another "I'm just asking" gambit by David Kirby, the same sort of rhetorical prestidigitation he performed for the Hannah Poling case, connecting condition after condition without any firm scientific evidence that a connection is warranted, each connection getting more tenuous as he continues.
But let's look at it this way. For the sake of argument, let's say MMR or other vaccines can cause ADEM, which can then lead to PDD-NOS or even full blown autism. Let's say that, just as RFK, Jr. and David Kirby are claiming, that's exactly what happened to Bailey Banks. Here's the problem. ADEM occurring after vaccination is very rare--so rare that it's very difficult to determine whether it's even correlated with a vaccine. For example, this study, looking at post-marketing adverse events from vaccines in Japan, reported the total estimated incidence of serious neurological incidents, including ADEM, encephalitis or encephalopathy, and Guillain-Barré syndrome, after vaccination as 0.1-0.2 per million immunization practices. That's incredibly rare. (NOTE ADDED AFTER POSTING: Note in the ADDENDUM that PalMD points out that the incidence of ADEM after measles and some other viral infections is 5,000 to 10,000 times higher than after vaccination, on the order of 1 in 1,000. In other words, the risk of ADEM after getting the measles is several orders of magnitude higher than it is after MMR vaccination--if there even is an elevated risk of ADEM after MMR vaccination at all!)
Of course, Kirby has an answer for this:
ADEM is said to be rare, but the disorder may be grossly under-diagnosed (or misdiagnosed). Even the government's chief witness against Bailey's case testified that he sees patients with ADEM "on a fairly regular basis.
Note the cleverness, so pathognomonic of Kirby's writing style. ADEM itself may not be incredibly rare, but ADEM is very rare associated with vaccination. At the end of the article, Kirby repeats the sentiment:
People will argue that ADEM is rare; that vaccines "only" caused PDD in Bailey; and that this was a legal and not scientific decision. The problem is we don't know how prevalent ADEM is because we never looked; while "PDD" is interchangeable with "ASD" in the language of public health. And, the three cases that lost were also "legal" decisions.
No, scientists and doctors have looked. There are numerous epidemiological studies and post-marketing surveillance studies looking for neurological sequelae after vaccination, be it with MMR or any other childhood vaccine. We just haven't found what Kirby wants us to find, which is why his definition of "look," apparently, is to do CT scans and MRIs on every child brought to the emergency room with any complaint at all after vaccination. Also remember that Bailey underwent an MRI because he had a seizure associated with fever.
I once labeled the vaccine-autism hypothesis the "incredible shrinking causation hypothesis." This tag-team assault is yet more evidence of that. Remember, the original contention of the antivaccine movement was not that vaccines could cause autism through some rare preexisting condition (mitochondrial disorders) or an even rarer demyelinating reaction (ADEM). No! It was that vaccines are responsible for the "autism epidemic." For that to be true, vaccines would have to be a major--if not the predominant--cause of autism. By latching onto a rare mitochondrial disorder as the "linking factor" between vaccines and autism last year and now latching onto a very rare possible complication of vaccination, ADEM, as a "gateway" to autism, using only a legal ruling and in essence no science, Kirby and Kennedy are showing just how small the vaccine hypothesis for autism has shrunk. Even if such a link exists and is ultimately scientifically confirmed (unlikely) it could not account for very many cases of autism--just as mitochondrial disorders couldn't account for very many cases. Moreover, even more so than neurological complications in children with mitochondrial disorders, neurological complications due to ADEM are more likely to occur in the unvaccinated because measles is more likely in such children. Science, facts, and reason notwithstanding, look for a lot of very bad "science" to pour out of the "labs" of Thoughtful House, Mark and David Geier's basement, and Boyd Haley's lab, wherever that may be these days.
It's also rather convenient that the antivaccine movement seemingly forgot about this particular ruling, given that it was issued in 2007 and Kathleen Seidel blogged about it and others nearly a year ago. One wonders why they waited until now to trot it out. Actually, one need not wonder. Pre-Autism Omnibus ruling, even the antivaccine movement considered the Banks case thin gruel indeed. If that weren't the case, the Banks case would have received major hype long before now. Post-Autism Omnibus ruling and Andrew Wakefield revelations, Generation Rescue needs something to distract people from the drubbing they've taken scientifically and legally. So they pull an old ruling out of the closet, tart it up a bit using their post-Poling spin skills, and send it flouncing down the runway and hope it impresses.
And if that doesn't work, RFK, Jr. cranks up the paranoia:
Although the vaccine court is mandated to fairly serve the victims of vaccine injuries, their primary purpose and raison d'etre is to protect the vaccine program and vaccine makers. Damages are doled out from a 75-cent tax on every vaccine sold and not from the vaccine makers. "You can understand why special masters, burdened with their duty to protect vaccine programs, might be unwilling to make the direct causal link between autism and vaccines," Krakow observed. "If you ask the big question and answer it in the affirmative, there is a sense that it will damage the vaccine program irreparably."
Vaccine Court judges are equipped with a draconian armory of weapons deployable against plaintiffs intent on proving the causal connection between vaccines and autism. Jury trials are prohibited. Damages are capped; awards for pain and suffering are strictly limited and punitive damages banned altogether. Vaccine defenders have an army of Department of Justice attorneys with virtually unlimited resources for expert witnesses and other litigation costs. Plaintiffs, in contrast, must fund the up front costs for experts on their own. In a cultural choice that clearly favors defendants, vaccine court gives overwhelming weight to written medical records which are often inaccurate -- over all other forms of testimony and evidence. Observations by parents and other caretakers are given little weight.
Consider this: If the proceedings are so rigged against the petitioners, why is it that the U.S. government pays their legal fees? Remember, the abusive lawyer Clifford Shoemaker? Remember what caused him to go after Kathleen Seidel with legal thuggery? What pissed him off was Seidel's revelation of just how much money he had made from representing Vaccine Court petitioners. In fact, the Vaccine Court goes beyond paying legal fees, even for those who lose, as Kathleen Seidel has explained. In fact, the law guarantees payment of attorney's fees and costs incurred by petitioners in presenting a claim to the Vaccine Court, as long as the claim is brought in good faith and the costs are deemed reasonable and necessary.
In other words, RFK, Jr. is either grossly misinformed or lying. Or, I suppose, he could be too lazy to have bothered to look it up. Take your pick again.
Particularly amusing to me is RFK, Jr.'s rant that the court gives overwhelming weight to written medical records. What else is the court supposed to give the most weight to? The very fallible human memory of people involved in litigation? Humans are very prone to confusing correlation with causation, as well as confirmation bias, and the tendency to subconsciously adjust memories to conform to beliefs. Medical records may be fallible, but eyewitness testimony is even more fallible. Indeed, the Michelle Cedillo case shows that, given how the parents insisted that her neurological problems started after her vaccine. Videotapes taken before she was vaccinated showed that her abnormalities were pre-existing.
Finally, to cap off the advertisement in USA Today and the tag team crankfest of David Kirby and RFK, Jr., Generation Rescue pulls out all the stops, trotting out--yes, you guessed it!--Jenny McCarthy and her boy-toy Jim Carrey. Check out this press release:
"It was heartbreaking to hear about Bailey's story, but through this ruling we are gaining the proof we need to open the eyes of the world to the fact that vaccines do, in fact, cause autism," said Jenny McCarthy, Hollywood actress, autism activist, best-selling author and Generation Rescue board member. "Bailey Banks' regression into autism after vaccination is the same story I went through with my own son and the same story I have heard from thousands of mothers and fathers around the country. Our hope is that this ruling will influence decision and policy-makers to help the hundreds of thousands of children and families affected by this terrible condition."
Chiming in immediately after is her boyfriend:
Jim Carrey, Hollywood legend and Generation Rescue board member, reacted to the news, "It seems the U.S. government is sending mixed messages by telling the world that vaccines don't cause autism, while, at the same time, they are quietly managing a separate 'vaccine court' that is ruling in favor of affected families and finding that vaccines, in fact, were the cause. For most of the autism community the question is no longer whether vaccines caused of their child's autism. The question is why is their government only promoting the rulings that are in favor of the vaccine companies."
In the face of such towering, burning stupidity, the gods themselves contend in vain. No, Jim, the question is why morons like you and Jenny think your Google University education trumps science, epidemiology, and the accumulated knowledge based on mountains of epidemiological and scientific evidence, and why you think that a legal ruling on science means anything whatsoever. After all, I was pleasantly surprised when the Autism Omnibus was ruled correctly based on the science, without even a hint of wiggle room for antivaccine loons to claim that the door is still open. When I found out about it, I was less surprised by the Banks ruling than I was by the rejection of the test cases in the Autism Omnibus.
I could go on, so much crazy is there, especially in RFK, Jr.'s article, where he complains to high heaven, wailing and gnashing his teeth, about how plaintiffs' attorneys can't get access to the Vaccine Safety Datalink. Gee, you don't think it has anything to do with concerns about the confidential medical information under HIPAA for the millions of records contained in that database, do you? Or perhaps knowledge of how antivaccine warriors Mark and David Geier tried to alter file extensions and merge datasets, very possibly to match names with cases. True, they denied it, but as Kathleen Seidel wrote:
To justify their attempt to merge datasets, they refer to the absence of direct identifiers in patient records, apparently unaware or dismissive of the well-documented fact that aggregation of indirect identifiers (such as race, sex, birthweight, APGAR, maternal age, gestation, and date of vaccination) would compromise the confidentiality of private health information. Modern data mining software heightens the risk that patient confidentiality might be compromised by statistical researchers, hence the proliferation of guidelines for the conduct of such research.
Of course, legitimate researchers can get access to the VSD. Indeed, numerous studies have looked at the VSD data on vaccines, none finding any correlation between vaccines or thimerosal in vaccines and neurodevelopmental disorders. If the antivaccine movement had any scientists other than crank scientists, it could do studies using the VSD data too. All it takes is a protocol that can be approved by an IRB.
The rest of the usual tropes are trotted out, too, like the claim that the CDC is suppressing research and the brain dead analogy between the science of vaccines and how tobacco companies tried to suppress the epidemiological data showing a strong link between cigarette smoking and cancer. I've dealt with this one before; so I don't feel the need to deal with it again, but I will say that it's a sign of a diehard antivaccinationist to make this specious comparison.
What we are seeing here is what GR can achieve when Jenny McCarthy's and Jim Carrey's starpower and fundraising prowess is yoked to the increasingly desperate propaganda of the antivaccine movement. When that happens, we see full page ads in major national newspapers coordinated with a propaganda blitz. Indeed, if there's any doubt now that the Huffington Post is now a propaganda organ for Generation Rescue and the antivaccine movement, this incident ought to erase it. The only thing keeping it from turning into Age of Autism is the fact that vaccine blogging is only a tiny part of what's published there.
What we are also seeing here is desperation. J.B. Handley, for all his other flaws, is not stupid. He sees the writing on the wall. Study after study have failed to find even a hint of a link between mercury and autism or vaccines and autism. The Vaccine Court, which , as the Banks case shows, is about as plaintiff-friendly as can be, conclusively ruled against the vaccine-autism hypothesis. The hero of the antivaccine movement has been revealed for the world to see as not just a dishonest man in the pay of lawyers suing vaccine manufacturers and hiding his conflict of interest, not just an incompetent scientist, but as a scientific fraud. He knows that, in the reality-based world, the last nails are being driven into the coffin of the vaccine-autism hypothesis. (They were actually driven in a few years ago, but this zombie somehow keeps managing to pound enough against the coffin to dislodge them.) However, he knows that he might still keep it alive in the court of public opinion if he's clever enough, and that's all he wants and needs, even if science examined and refuted his unswerving belief that vaccines cause autism years ago.
Sadly, he is probably right. Religious fanaticism always has an advantage over dry scientific study, and there are always credulous "report both sides" bloggers and journalists to be taken in. Money doesn't hurt, either.
ADDENDUM: PalMD points out that Kirby and Kennedy are even more dishonest than I describe:
The Banks case to which K&K are referring is interesting as a case of "I don't think it means what you think it means." The case examined a young patient who received an MMR vaccine, and then 16 days later suffered a seizure. He was evaluated and at least one doctor felt he had ADEM, a severe neurological disease. The best statistics estimate a rate of ADEM after measles vaccination of about 1-2 per 1 million, although the vaccine has never actually been proved to cause ADEM. The rate of ADEM associated with measles infection is about 1 in 1000, a proven causation.
And:
Notice, this is not a "vaccines cause autism" finding---it is a "in this particular case, a vaccine may have cause ADEM, which may have lead to an autism-like disorder." If this is the best argument K&K can come up with, they probably should have given up a long time ago.
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Thanks for all the link love, Orac!
The "quietly and without fanfare" and "quietly managing" business is total baloney. Courts and administrative agencies don't routinely herald their rulings with fanfare except in cases about which there is already widespread public interest (such as the three OAP test cases). Courts and administrative agencies dealing with individuals' medical information don't generally go out of their way to publicize it, especially VICP, which limits access to court filings to parties of record. Contrary to what Kirby and RFK Jr. would like to imply, there was nothing underhanded about the Program's handling of the Banks entitlement ruling. It was issued in July 2007, posted to the Court of Federal Claims website shortly thereafter, and submitted to Thompson and West for publication. I downloaded a copy from Westlaw on September 17, 2007.
And of course, K&K left out the little fact that measles itself is associated with a significant rate of ADEM, about 1-2 in 1000, while vaccination, if associated at all, falls in the 1-2 per million range.
Ah, but the ADEM caused by measles is natural, so it must be harmless, right?
Sounds like Handley, John Best, Kevin Champaign, Jock Doubleday, Jenny McCarthy, Lynnette Redwood, John Erb, and some other antiscience, antivax psychos have decided that it's better to burn out than fade away. Maybe they're early Def Leppard fans?
Evidently. All of their statements regarding this case are well coreographed, intentionally timed, and frankly, quite dishonest.
It was not a "recently unsealed" case. The ruling predates the Poling case. The only new event was the award of damages. That's the one thing they took advantage of.
What they call a "mysterious court" now was the best hope for the petitioners only one month ago. That's a new frame they are trying out.
When they say "the government conceded vaccines cause autism" they know very well this is not what the decision means.
By way of analogy, suppose it is found that once a year, a person develops loss of memory as a result of a lightning strike. Would it be honest to claim then that "thunderstorms cause amnesia"?
I posted comment on wrong thread, but huffington post has this going today:
http://www.huffingtonpost.com/david-kirby/nih-agency-head-vaccine-a_b_1…
A major health official within the United States Government today endorsed more research into possible links between vaccination and autism, saying that such studies are "legitimate."
The official, Dr. Duane Alexander, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), an NIH agency, said scientists must investigate susceptible subpopulations of children, including kids with mitochondrial disorders and those who have trouble metabolizing mercury.
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the story only gets worse from there.....but what do you expect from Huffington...I do expect more from directors at NIH though.
Wow, those antivaxers really are a special sort of slime, it's a pity that they are slime with deep pockets.
Nice post.
here is link to Q&A with NICHD director Duane Alexander
http://www.autismspeaks.org/science/science_news/nichd_alexander_interv…
Vindaloo, sorry for picking this nit, but that's actually a Neil Young original. (Believe the song is "Hey Hey, My My" or something like that.)
Wow, those antivaxers really are a special sort of slime, it's a pity that they are slime with deep pockets.
Of course, when an organization has deep pockets it's more vulnerable to lawsuits...I wonder if anyone who has had permanent damage from contracting a vaccine preventable illness has tried suing Generation Rescue or any similar organizations yet. If not, maybe they should.
Kirby: "ADEM is said to be rare, but the disorder may be grossly under-diagnosed (or misdiagnosed)."
I don't believe any neurologist would ever miss such a case. The key features of ADEM are widespread demyelination. Patients with this condition show obvious motor findings on neurological exam (spasticity, hyperreflexia, occulomotor signs) that would be different from what you'd see in typical autism cases (usually associated with what are called "soft signs" such as posturing or repetitive motions).
MRI is exquisitely sensitive to demyelination. MRI would be grossly abnormal in ADEM - a neurologist would see the abnormality from across the room. MRI is generally normal in autism (or demonstrates mild & nonspecific findings that are uninformative); the AAN guidelines from 2000 recommend against routine MRI in evaluation of autism IN THE ABSENCE OF other features. In other words, ADEM is a very rare finding amoung children with autism.
Here's a good recent review: Neurol Sci. 2008; v29 Suppl 2:S286-8
Do vaccines cause ADEM? well, any immunologic stimulus can trigger ADEM. It comes after viral infections, including common colds and flu. ADEM is more common after wild virus infection than after vaccine. Neuroepidemiology. 1985;4(3):138-45
The vaccine courts seem to be doing the right thing: compensating those few children with true vaccine-related injury (even if the underlying condition may have led to a brain disorder with or without the vaccine), and avoiding compensation in the majority of the autism cases in which there is no causation.
disclosure: I work for a drug company, but not one with any position on vaccines or autism-related treatments.
Natalie: "Vindaloo, sorry for picking this nit, but that's actually a Neil Young original. (Believe the song is "Hey Hey, My My" or something like that."
I was going to pick that same nit but I know Lepard was quoting Neil and Crazy Horse. I was thinking the stupid cubed crew should do a cover of "Needle and the damage done" by same. Play it backwards guys. I heard, "GR is Dead" but the needle on my CD player needs replacing.
I expect to see the cover for sale at the next GR fundraiser.
I've been noticing a distinct pattern in the arguments the disease promoters made for the Omnibus, and this continues it. "You can't prove conclusively that this is NOT true, therefore we know for certain that it IS!"
By the same logic, autism is caused by the phase of the moon at conception...
By the same logic, autism is caused by the phase of the moon at conception...
No silly, autism is a misdiagnosis of demonic possession. The rise in Autism is just a side effect of the coming apocalypse. More demons escaping from Hell, more cases of possession.
I know I'm reposting this, but I can't resist Dominick Dunne's response to RFK Jr:
âI donât give a fuck about what that little shit has to say,â Dunne spits back. âThat fucking asshole. This pompous, pompous, POMPOUS man. I donât care what he has to say. Heâs not a person that I have any feeling or respect for.â
Dom, you da man!!!
Oh Orac, while I fervently hope for an eventual end to this antivax lunacy, it does tend bring out the best insolence, wherein your fisking is elevated to an art form.
Orac:
You meaningfully overestimate our sense of urgency or any "desperation" we may be feeling at the present time.
What we certainly feel is that the Vaccine Court's collective decisions have not been well understood by the media or anyone else. What has also become clear is that plaintiff attorneys have learned a simple truth: if you remove the "A" word from a claim, and focus on vaccines causing brain damage, you have a good shot of winning. If you bring the "A" word into your claim, you will lose.
The reason for this is simple: autism is impacting at least 1 in 150 children. If vaccines are behind this condition, the vaccine program is done. No special master will ever allow themselves to be the guy who brought down the vaccine program. Period. The Court's purpose is to uphold the vaccine program, not destroy it. The program is perceived as being "too gig too fail" and autism is its achilles heel.
Generation Rescue has a 5-10 year plan, not a one week plan, to meet our goals, which I will spell out for you here:
1. We want the world to know that you can recover from autism, or at least improve meaningfully, with biomedical intervention.
2. We want to prove that biomedical intervention works and optimize the treatments. We want to know why certain interventions work better for certain kids. (We reject the absurd notion of "spontaneous recovery")
3. We believe vaccines are serving as a primary trigger for kids who experience regressive autism, and we want the world to know this. We continue to receive case reports every day to support this position, and its not an underestimation that we have heard from tens of thousands of families with the same experience. We will fund the scinece to help explore this assertion further, as none of it has yet been done (see below).
4. We believe the vaccine schedule needs to be changed in the following ways:
- Children in general need to receive fewer vaccines. Reduction can come in two ways: eliminating certain vaccines like Hep b (except when Mom is positive) and Flu, and reducing the number of booster shots given (giving titer tests instead).
- Vaccines in general should be given when children are older.
- Precautionary rules need to become mandatory. Simple things like: no more than one shot per visit, no shots while on antibiotics, etc.
Orac, I remain mystified by your unwillingness to apply your "scientific" mind (which given your sputtering above may be a stretch) to this issue. As you well know, the only vaccine that has ever been studied in terms of its relationship to autism is the MMR. The ELEVEN other vaccines licensed for children never have been. You also know that every "scientific" study of any relationship between thimerosal and/or MMR has ONLY ever looked at vaccinated kids. You also know that vaccines have NEVER been tested for combination risk, and the safety studies on vaccines are wholly inadequate, with a typical 6-week observation period after a vaccine is administered.
The primary way vaccine safety is administered is backward-looking through VAERS and VSD. Since autism "isn't" caused by vaccines, the 1 in 150 kids with it aren't part of adverse events, so a loop of denial is preserved.
Orac, I hope your readers can compare these words to the sputtering rant and decide for themselves: which one of us is drinking the kool-aid?
JB Handley
Danio is right.
What an image! That's absolutely golden.
~David D.G.
"vaccine court gives overwhelming weight to written medical records which are often inaccurate"
In the comments to a previous post of yours I recall some antivaxxer emphasizing that you need to rely on medical records because "medical records don't lie". She repeated the same thing a few times seemingly not realizing that she had undermined her own case quite nicely.
Thanks for this recent post. Very informative.
-dj
Orac!! Another crank at NIH!! Do something:
A major health official within the United States Government today endorsed more research into possible links between vaccination and autism, saying that such studies are "legitimate."
The official, Dr. Duane Alexander, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), an NIH agency, said scientists must investigate susceptible subpopulations of children, including kids with mitochondrial disorders and those who have trouble metabolizing mercury.
Let me see if I got this right.
the case the Infectious Disease Proponents are writing about dates from 2007. Hanna Poling - their previous poster child was decided in 2008, and the three omnibus test cases were decided in 2009. It's been 2 years since the case they're discussing (and lying about) has been decided, and yet they want us to believe it was recent ? and no doubt suppressed by the EVIL GubMint! . . . the same Evil GubMint that they want to pay a half million initial settlement and say, 60,000 a year for life to people. The same Evil GubMint that is owned by the Vaccine Nazis ?
Where do I sign up to get vaccinated ?
I could use an income of 60k a year and a 500,000 cushion.
Perhaps this is a stupid question coming from a non-scientist, but if measles can cause ADEM, and the MMR vaccine is made up of weakened measles virus, isn't it possible that both sides have a point, although Orac the bigger one since the risk is so much lower? That is, that couldn't a weakened strain of measles lead to some measles symptoms in the child, but so rarely as to be statistically insignificant? Even if this is the case, it would seem to me that it would not be an argument against vaccination because the odds of getting ADEM are orders of magnitude higher in a non-vaccinated child due to the likelihood of catching measles being orders of magnitudes higher, but couldn't that be a linkage?
Help me out here--I'm not trying to ask a rhetorical question here.
Handley, Your mutation from ignorant "the whole notion of autism is a myth" (your quote from your TV spot, you moron) because of mercury to your staunch and equally ignorant antivaccination stance has been duly noted.
Surround yourself with D-lister actors and incompetent and dishonest practitioners (I will not call Geiers or Wakers scientists) all you want, the core of your small rabble is still you - a desperate idiot with some cash to burn. Your tiny voice has been amplified via web savvy and some money but you lack science and you lack honest research.
The Age of Autism and Generation Rescue is powered by nutjobs like Wakefield, John Best, Kevin Champagne, Mark Blaxill, Sue M., Jock Doubleday, Lynne Redwood, and you, JB. Yes, you, Bradford - how's the RNA quackery? Butter's stinky goo? Is Andy Cutler still in vogue? Have you bought a light-powered sauna? HBOT balloons? Algae extract?
I believe JB Handley has impure thoughts about goats. That is all.
Vindaloo:
I read your post, trying to see if you took exception with any of the points I made in my post and realized you hadn't. I'll ask the same question: which one of us is the kool-aid drinker?
Me, or Vindaloo the Sputtering AdHominem-er? (Who, like all of you, posts anony-mouse-ly.
" I hope your readers can compare these words to the sputtering rant and decide for themselves: which one of us is drinking the kool-aid?"
OK, I've read them both. Your arguments, JB, are weak at best, your recommendations are unfounded by any research, and what research exists you discount. You are not interested in either improving the safety outcomes for children or finding answers to your own questions, rather, you are fully intent on proving to the world that you are right. Scientist, physicians, judges...all can be damned. You've got the answers.
Do you firmly believe that biomedical interventions are effective? Great! Then get a group of doctors together and fund a study, have it peer-reviewed, and present the data. It's that simple! Do you want a vaccinated vs. unvaccinated survey? Commission a university group to take one, then have it peer-reviewed, and present the findings at symposia. Think the schedule should be changed? Great, but you're going to need evidence, not just shit arbitrarily pulled out of your ass. Fund studies. Provide the burden of proof that is required.
The path seems fairly straight forward. Instead, your primary avenues seem to be baseless accusations of conspiracies and devious deceptions by corporations AND government agencies AND academic institutions AND private individuals, on a global level. Sorry, but no one (of any importance) is buying it, no matter how much you spin whatever 'facts' you manipulate or contrive.
Policy is going to formed by facts, not by personal opinion. If you are firm in your perspectives, you should put your money where your mouth is and step up to the plate. Everything else you do/say is just bullshit whining.
RJ:
I spend little of my time whining, although your post is quite whiny itself.
But, I agree with most of what you write: while the burden shouldn't necessarily be on parents, it is. If we don't make real science happen, no one else will. Behind the scenes, I spend my time worrying about how to raise enough money to do just that.
2 points for you:
1. A lot of people spend time saying "science proves vaccines don't cause autism." Since only one vaccine, MMR, has ever been studies, it drives me nuts that a bunch of people who claim to be scientists say this with a straight face. They are either lying or very stupid.
2. While you say the burden is on us to do studies to change the schedule, where are the studies that show this many vaccines are safe? How come they don't test vaccines for combination risk, even though that's the only way they are administered? Why is that OK with you?
It's remarkable how much you people feel you need to insult me personally to make your points. Perhaps you take your cue from Orac's writing style.
I'll be the first to concede that good points are often made by Orac and his readers, but to not do the same in return shows a closed mind.
The only community that has a strong and clear hypothesis for both cause and cure of autism is our community. Meanwhile, many of you are certain of what doesn't cause autism while having no clue what does. For a parent, that's not very actionable of comforting.
By the way, we are winning the war with parents, which is the most important war to win, because then fewer kids develop autism.
JB Handley
JB Handley: "We believe vaccines are serving as a primary trigger for kids who experience regressive autism, .... We continue to receive case reports every day .... its not an underestimation that we have heard from tens of thousands of families with the same experience."
Here is the fundamental error. Yes, an inflammatory reaction caused by a vaccine appears to have been the trigger in at least 2 cases (one a mitochondrial encephalomyopathy, related to a rare genetic abnormality and the other ADEM, and exceedingly rare autoimmune reaction). In both of those underlying conditions, any inflammatory event, vaccine- or wild virus, could trigger the CNS injury. The vaccine was not the cause in either, it was merely an inciting trigger to a child who would have had a problem either way. The court bent over backwards to compensate the children.
And both of those underlying conditions are RARE RARE RARE. It's ridiculous to claim that there's a lot of unrecognized & underdiagnosed ADEM out there - ADEM is obvious to any skilled observer. (see my earlier post).
Neither of these rare conditions (mitochondrial defects or ADEM) are a statistically detectable fraction of the nation's autism cases.
That's why the autism courts can compensate a few patients while confirming that the claims of the great majority are baseless. That's why, when Kirby writes (in the HuffPost article cited by Orac) "But why should parents feel reassured when two out of five autism cases (40%) - that we know of - have won taxpayer-funded compensation in Vaccine Court?" - he is being misleading.
and by the word "misleading" what I really mean is "lying".
David:
ADEM description:
"Acute disseminated encephalomyelitis (ADEM) is characterized by a brief but intense attack of inflammation in the brain and spinal cord that damages myelin â the protective covering of nerve fibers. It often follows viral infection, or less often, vaccination for measles, mumps, or rubella. The symptoms of ADEM come on quickly, beginning with encephalitis-like symptoms such as fever, fatigue, headache, nausea and vomiting, and in severe cases, seizures and coma."
David, please show these symptoms to any and all parents of children with autism you know. I would guess that MOST had a child who experienced something like this or worse and I would bet that of those who took their child to their small town pediatrician, which is what most of us did, I would bet less than 1% got an MRI or heard of the word ADEM.
JB
Well, yes, because it is well established scientifically that vaccines can produce brain damage, albeit much, much more rarely than the diseases that they protect against, the evidence is also clear that vaccines do not cause autism in the absence of gross brain damage. And the remarkable thing about the typical autistic brain (samples of which may be readily obtained by autism researchers from a tissue bank set up to support autism research) is just how normal it appears to be. There are some differences at the level of receptor abundance and cell distribution, but they are quite subtle. The autistic brain simply doesn't look like a damaged brain; it looks like one that didn't grow quite right.
Mr Handley, why are you lying?
You know that studies of unvaccinated vs vaccinated kids have been done (the well known Finnish twin study, for one). You may think these are inadequate, but that does not excuse your saying they do not exist.
Mr Handley, why are you lying again?
A simple pubmed search on the safety of combination vaccines yields 642 research papers on the subject.
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=link&linkname=pu…:
Mr Handley, why are you keep on and on lying?
I can immediately think of another long term Finnish study where 3 million doses of MMR were given, with prolonged post vaccine surveillance for side effects.
Why must you repeatedly lie, trying to pretend that the available evidence doesn't even exist, rather than doing the scientifically honest thing, and subjecting it to critical appraisal?
"You also know that vaccines have NEVER been tested for combination risk, "
What nonsense. According to Dr Offit that's strictly routine to test new vaccines in combination with the current schedule. What you folks have resorted to is insisting that a comparison between vaccinated and unvaccinated children is going to get your heart's desire that in some nebulous way -which you never define, vaccines in general cause autism. That's highly unlikely given what we already know about vaccine safety. What exactly is it about vaccines that you think is at fault?
And while ever you continue to hide behind the real problems in conducting such a study, nothing happens. No doubt that suits your agenda very well. It allows you to remain perpetually dishonest. Why you are so behind biomedical tratments which don't seem to have done anything out of the ordinary for your own son, is something of a mystery. Stubborn are you?
JB Handley: "We believe vaccines are serving as a primary trigger for kids who experience regressive autism,"
Keyword in that statement is "believe". Your campaign is faith based and has no basis in science and fact.
David said "And both of those underlying conditions are RARE RARE RARE. It's ridiculous to claim that there's a lot of unrecognized & underdiagnosed ADEM out there - ADEM is obvious to any skilled observer. (see my earlier post).
Neither of these rare conditions (mitochondrial defects or ADEM) are a statistically detectable fraction of the nation's autism cases."
And what has also been pointed out, they can both be triggered by infection with a real disease like measles. As PalMD pointed out "The rate of ADEM associated with measles infection is about 1 in 1000, a proven causation."
The return of measles to the USA would not be beneficial to the health of American children.
Handley's other 5-10 year plan:
1. We want parents to know that quack bio-medical treatments are not child abuse as long as it's done with love, or something that is easily mistaken for love by people who aren't paying attention. Like Oprah, for instance.
2. We will identify and cultivate celebrities and other credulous media types and persuade them that biomedical interventions work, despite the total absence of credible supporting evidence. We want to know why certain interventions work better for certain kids, while ignoring that in the absence of a control group, and given enough time, exorcism will appear to work. (We reject the absurd notion of "empiricism.")
3. We believe vaccines can serve as a primary trigger for an avalanche of spurious lawsuits, quack infomercials, vacuous microcelebrities, and cookies that taste like cardboard, but we don't want the world to know this. Instead, we will continue to frame our arguments in sciencey-sounding language, and play the victim card whenever the AAP, CDC, FDA, or those nosy child welfare agents even look at us. We will fund Mark and David Geier, and Thoughtful House, and that guy who perforates bowels while tracking the elusive measles virus.
4. We believe the vaccine schedule needs to be changed in the following ways:
- Children in general need to receive fewer vaccines. Eliminating the polio virus, for instance, will reduce vaccine injury and jump-start America's moribund iron lung industry.
- Vaccines in general should be given after children have reached the age of consent, so that if they do become vaccine injured, then at least they can legally have sex to make them feel better.
- Precautionary rules need to become mandatory. Simple things like: hypodermic plungers that play Mozart's Requiem Mass in D minor as the vaccine is injected directly into a child's bloodstream; orange haz mat suits for all medical personnel working within 50 feet of the "vaccuary"; and free drool cups for children who descend into the hell of autism before the parents leave the doctor's office.
JB said:
"We believe vaccines are serving as a primary trigger for kids who experience regressive autism, and we want the world to know this. We continue to receive case reports every day to support this position, and its not an underestimation that we have heard from tens of thousands of families with the same experience. We will fund the scinece to help explore this assertion further, as none of it has yet been done (see below).
We believe the vaccine schedule needs to be changed in the following ways:
- Children in general need to receive fewer vaccines. Reduction can come in two ways: eliminating certain vaccines like Hep b (except when Mom is positive) and Flu, and reducing the number of booster shots given (giving titer tests instead).
- Vaccines in general should be given when children are older.
- Precautionary rules need to become mandatory. Simple things like: no more than one shot per visit, no shots while on antibiotics, etc."
RJ says:
What is the purpose for all these changes? What will it accomplish?
All these changes are based on what? What are the studies, measures, criteria, etc. for making these changes?
And this great big experiment involving everyone else's children...what will be deemed a successful adoption of your guidelines and what will be deemed failure (for example, if it is like when thimerosal was phased out of use and autism rates remained unchanged = failure; if the infant mortality rate increases due to preventable infectious diseases = failure or accomplishment)?
What do you expect the outcome to be?
I will NOT be holding my breath waiting for a response to these questions. If I were you, I wouldn't try and answer them either. But, if you think you will ever be taken seriously or have your dream world implemented, you will have to eventually address these questions.
DT:
I'll preface by stating that I told myself I'd never post here again, only lurk then stumble off cussing. But I feel it must be pointed out that in the pubmed link you've provided, in the very first paper listed:
[Four hundred infants were randomized into one of four study groups and immunized at 2, 4 and 6 months of age. Group A received three doses of DTaP-HB-IPV; Group B received DTaP-HB-IPV at 2 and 4 months and DTaP-HB with OPV (Orimune) at 6 months; Group C received three doses of DTaP-HB with licensed IPV (IPOL) administered separately; Group D received separate doses of OPV, DTaP (Infanrix; GSK) and HB (Engerix; GSK). All subjects received conjugate Haemophilus influenzae type b vaccine (Hib) (OmniHIB) at 2, 4 and 6 months of age given at a separate injection site.]
This is comparing vaccinated children to vaccinated children. This particular paper is a push for more combos, and not surprisingly, offers very little concrete information as it relates to safety other than the standard AE monitoring. (Which is not always carefully handled)
In the next:
[In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP(5) coadministered with IPV and Hib vaccines or 1 lot of DTaP(5)-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP(5) and Hib vaccines or a fourth dose of DTaP(5)-IPV-Hib at 1 to 16 months of age.]
Vaccinated children compared to vaccinated children.
Next:
[Infants received either a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio virus-H. influenzae type b vaccine concomitantly with PCV7 or DTPa-HBV-IPV/Hib alone infants were vaccinated at 2, 3 and 4 months (primary immunization) and 12-15 months of age (booster dose). ]
Vaccinated children compared to vaccinated children.
Next:
[Two hundred infants were randomized to receive either DTaP-IPV-Hib or DTaP-IPV plus Hib vaccine at 2, 4, and 6 months of age. Both combined vaccines contained the same five pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae 2 and 3 (FIM 2&3).]
Vaccinated children compared to vaccinated children.
Next:
[An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of a pentavalent DTPa-IPV vaccine mixed with a Hib vaccine (DTPa-IPV/Hib), simultaneously administered with HBV (Group 2) in two injections in opposite thighs, as a primary vaccination course, to healthy infants at 2, 4 and 6 months of age.]
I'm not going to go through each paper, I don't have the time... but I'd venture to guess they are more of the same. Vaccinated children, compared to either more or less vaccinated children in different combinations of vaccines. Perhaps that signals their safety to you, but what it signals to me - is that there isn't a true placebo to be found.
I don't believe anyone's suggested a vax/nonvax study which would involve children of vaccinating ages... I've simply seen the request for a large scale epidemiological study that addresses overall health outcomes of each group. It may be true that locating such individuals in an acceptable manner (not affecting methods) might be a challenge.
My question, is that if it potentially exonerates vaccines (in the eyes of those that you consider "anti-science"...) - why wouldn't you be in favor of such a study? If VAERS is such a joke, why is there no advocation for a true mandatory reporting system? If it would potentially silence the opposition, why aren't vaccine defenders fighting for such a system? If those opposing vaccines are doing so out of safety concerns, and as it relates to accurate reporting - why wouldn't we ALL want to correct that?
We all know what the flaws within the Vaccine Court are (Daubert, etc. etc). The recent rulings offer nothing to the debate, but plenty to controversy.
Oh yes, JB has the last word in dishonesty. Look where he had to add [autism] to the wording of the decision. The actual decision says 'non autistic developmental delay'. A lot of folks will be fooled by that. How do you feel JB that you have to resort to fooling people to get them to agree with you?
JB, what do you suggest that we do to protect children from communicable disease before they are "old enough" to vaccinate? Keep them in a bubble, safe from all pathogens and any human contact? You know what will happen then: Babies don't live without human contact, and children, if they survive, are seriously, seriously messed up. Are you suggesting that it would be better to deliberately and knowingly damage the development of children, rather than vaccinate them, which carries virtually no danger of developmental damage?
I don't know about you, but if I were given the choice: miserable, stunted, abused children or happy, bright, normal, vaccinated children, I know which one I would chose.
But at least you are upfront in your infectious disease protection campaign.
Once again, another anti-vaxx0r criticises the mainstream literature for not comparing unvaxxd to vaxxd.
Yet again they fail to name or even indicate any process by which any relationship will show in a 1/0 study but not be indicated in multiple less/more studies.
Are they truly claiming that vaccine induced autism is a 100% event? That is, anyone supceptible to it will get it after only one vaccine?
Aren't these the same courts that wrote "After careful consideration of all of the evidence, it was abundantly clear that petitionersâ theories of causation were speculative and unpersuasiveâ¦" (see Kathleen's weblog: http://neurodiversity.com/weblog/article/184/) Either way, shouldn't the courts be filing some sort of misrepresentation charges at them? It does seem to be a straight-forward case of misrepresenting the statements of a court-?
JB,
If you had a brain half as big as your ego, you would have cured autism already. Congratulations on planning to waste the next 5-10 years of your life. Do you really think that the public is going to let your pro-disease agenda prevail? Sure you might convince a few more California New Agers to run along with you, but the long term impact will amount to nothing.
J.B.'s monumental meandering mass of misinformation that he's just laid down in my comments will take too much time to answer and will therefore have to wait until later, after I get home, if I have the energy for it all. (More often than not, I really do prefer spending my energy and effort in producing new posts for this blog, rather than getting into endless sparring matches with the unconvincible in the comments, where few of my readers are likely to see my scintillating brilliance. Oh, by the way, J.B., that's self-deprecating humor; I know you have a hard time telling given that you seem to have that attitude about your self in all seriousness.) However, I can show you an excellent explanation why what you propose is very impractical and difficult. Behold!
"Let's put on a study!"
One word: Confounders.
Marc | February 26, 2009 4:10 PM,
It's already been explained that ADEM isn't usually associated with autism. See: David | February 26, 2009 11:00 AM
anon,
The references provided address exactly what the issue was: "You also know that vaccines have NEVER been tested for combination risk". Those studies have all been performed to demonstrate exactly that.
Your beef with it is that it does not include a control, placebo-injection group. You will never, ever find this to be the case. Simply, no one can or will perform an experiment such as the one you are suggesting, consciously putting a population of children at risk for an experiment. The fact exists, and it cannot be denied or ignored, that for decades, all around the world, children have been effectively and safely vaccinated. You are going to have a difficult time convincing anyone that vaccines contribute to imminent or probable damage. It simply is not true. What you are saying is that it would be like testing to see if there are dangers with proteins in foods (because no one has ever tested to see if they are safe, and no one has done a with-protein diet compared to a protein-free diet experiment, therefore, we don't know if proteins in food are safe). The vast, vast majority of children are effectively and safely immunized from diseases that are disabling and sometimes deadly. There will never be a placebo-vaccinated group for this reason.
JB Handley writes:
1. A lot of people spend time saying "science proves vaccines don't cause autism." Since only one vaccine, MMR, has ever been studies, it drives me nuts that a bunch of people who claim to be scientists say this with a straight face. They are either lying or very stupid.
And by you own argument, you have no evidence to claim that vaccines cause autism either. You seem to have forgotten that this line of argument has to cut both ways, by definition. If there really were no evidence, that no evidence plays both ways, both for and against.
Mr. Handley,
you want to remove the HepB shot? But your own blog pointed out that the autism rate in Isreal is MUCH lower than that in the United States.
Yet, Israel has the birth Hep-B vaccination.
Frankly, as a scientist, I don't think that's enough data. But, your organization uses EXACTLY this sort of logic. The parallel between the Danish autism rate and your irresponsible recommendations for "alternative" vaccine schedules is the case in point.
I am interested to see a 5-10 year plan. I thought in 2 years it would all be solved through chelation. You owe a lot of people apologies for sending them down that path. That's putting it lightly.
"By the way, we are winning the war with parents, which is the most important war to win, because then fewer kids develop autism."- JB Handley
At last, a true statement from Mr Handley.
Letting a child die of a preventable disease by denying them a safe vaccine is a sure fire way of preventing that particular child developing autism (well, ignoring the strong hereditary evidence that suggests the child will already have autistic traits).
As preventative medicine goes, it's a tad harsh, but "fewer kids" will eventually mean "fewer autistic kids". I didn't realise that was the anti-vaxers aim until it was spelled out.
JB handley writes:
The only community that has a strong and clear hypothesis for both cause and cure of autism is our community.
LOL. Utter self-serving rubbish, of course. A more relevant point though is who has an honest understanding of what is known or not: the research community. While JB spends money and time attacking "the pharma industry/government", he should be reminded that the research community don't operate in the manner he proposes.
Alyric writes:
Oh yes, JB has the last word in dishonesty. Look where he had to add [autism] to the wording of the decision. The actual decision says 'non autistic developmental delay'.
Would this be sound reason for the court to press for misrepresentation of their findings?
Orac writes: One word: Confounders. I agree. (Part of my expertise is in data analysis.)
JCmacc, I'm afraid you're right in one thing, it will take dead kids to get these quacks to go away. Only when Oprah gets to interview a "Jenny told me not to vaccinate and now my child is dead" mom will the JBHs lose their sway over misguided parents.
That's insane talk. No child psychiatrist would look at those symptoms and say "autism!"
RJ,
Your points are fair enough, but it does not change the fact that vaccines (in general, not just combo) do not contain a bona-fide control group.
Many children were harmed by early polio vaccines, and DPT vaccines. As science evolves to refine the biologic, it is fair to say that in *some* children that the damage may not be overt... it's still damage. How much damage is okay? Small. Large. None. I think that might depend on the child. Since the damage, or lack thereof, happens to an *individual* child (who is not properly screened for genetic predisposition, allergies etc...) - and not the herd, why are parents being admonished from trying to protect their children from potential harm? In the end, it IS about the individual - unless you are claiming to be an emotional and financial crutch to those that DID vaccinate and suffered because of it?
I think both sides would fare better by removing sensationalism, it undermines both positions.
"J B Handley" bleats :
Yeah, J.B. I read them both, and I have to say:
try less sugar in the kool-aid next time, it'll leave you less jittery.
"JB Handley" also blathers:
Right. We know you are who you say you are because you typed your name into a box. Get real. I could post here as Barak Obama, JB Handley or John Bernard Books.
Trashing someone because they post under a psuedonym ?
Dude, that's so 1991.
There's something so pathetic about GR's latest gambit. They've spent how many thousands on this advertisement? And it's all for a lie and having to add 'autism' to the decision. It's such a pity that the decision writers will never use the autism word. Well they can't, it wouldn't be honest.
What is equally pathetic is that the ad reader will never know that ADEM is as rare as hen's teeth and couldn't put a blip in the autism prevalence rates.
So what have GR donors got for their hard earned money? Two lies and nothing else. Sooner or later JB somebody's going to start asking rather awkward questions. One of those might run along the lines of why in the face of the overwhelming verdict of the Omnibus has GR only been able to dust off a two year old vaccine table injury payout and try to make it sound significant when it is almost irrelevant - as far as autism goes at any rate.
Maybe donors don't mind being lied to.
Orac,
I do agree that confounders increase over time, if they are adequately addressed at all. What kind of confounders would be present over a 10 year study? One that attempts to exonerate certain amounts of thimerosal, versus more amounts of thimerosal? You appeared to favor that study (Tozzi et. al), if I recall your analysis... feel free to correct me.
[Children who were enrolled in an efficacy trial of pertussis vaccines in 1992â1993 were contacted in 2003. Two groups of children were identified, according to thimerosal content in vaccines assigned randomly in the first year of life (cumulative ethylmercury intake of 62.5 or 137.5 g), and were compared with
respect to neuropsychological outcomes] No doubt these authors addressed the difficulty within their selected task:
{Assessing the effects of thimerosal in vaccines long
after immunization is complicated by a variety of factors
that potentially affect the quality of data on vaccine
exposure and measures of neuropsychological development.
Controlling for social and educational factors and
some health conditions may be difficult in observational
studies in the general population, in the absence of
high-quality records including information on each
of these factors.]
Yet, many, many outlets (media and otherwise) picked up this study and simultaneously ran headlines of how thimerosal had been exonerated in any damage to the potential vaccinee. Or is it that verifiable, reproducable tidbit by tidbit goes into the balance?
Can you explain why you would favor that study (enough for a blog entry), and be opposed to something similar with a non-vaccinated control group?
It appears that many hammer upon those that are supposedly not on the side of "science", when in fact, they are simply wanting consistency.
anon said "why are parents being admonished from trying to protect their children from potential harm?"
Buy why are they risking a 1 in 1000 chance of real neurological damage from measles against the much smaller chance with the MMR?
One reason is the fraudulent information put out by Kirby, Generation Rescue and others who are supporting Wakefield committed fraud with his now retracted paper.
Sure, you can protect your children --- but first you need to know the real risks, not the "beliefs" of Handley and others.
Chris, fair enough.
Anon,
Again, NO ONE WILL PERFORM, OR BE ALLOWED TO PERFORM A VAX V UNVX STUDY INVOLVING CHILDREN. That clearly puts children at risk. No organization will get funding and I seriously doubt the parents of the test subjects will sign away rights to participate in an experiment that will leave those randomly assigned to the control group susceptible. None of those test subjects would be able to attend school (no documentation will be available to keep the placebo group blinded), as well as travel, visit ill relatives in hospitals...the list goes on. Furthermore, what will you be looking at after 10 years? How In the world would anyone be able to control and account for all the variables that these subjects will encounter over 10 years? What you are asking is simply impossible.
However, there is an alternative. One that covers all of your bases. Animal studies. Although the animals are not allowed to live a life in the wild and are not exposed the large number of infectious diseases they would be exposed to in the wild, they are subject to multiple vaccinations and checked for adverse reactions afterward (for weeks). They are also examined after many years, the equivalent of 10's of years for humans. What are the results? I suggest getting off your computer, go to a university library, and look at the results yourself. It's been done...ad nauseam. (Hint: this is another reason why no one is worried about 'long-term effects' of vaccines).
You have an exceptional writing style and participate fairly in a fruitful and civil discourse. Thank you for sharing your questions and perspectives.
Anon,
Also, you can look at the numerous trials conducted in other countries and those with adults.
For example:
http://clinicaltrials.gov/ct2/show/NCT00072605
And for the recent trials involving vaccines conducted in the U.S. (does not include international studies):
http://clinicaltrials.gov/ct2/results?term=vaccines
Correction. The NIH site does include international studies, but not all. Foreign regulatory agencies often require their own studies (and those are the ones not on the list). Sorry for the confusion.
trrll seems to have left off a end of his blockquote... I would also like to add that a good explanation of the problems with vax/unvax idea is here:
http://photoninthedarkness.com/?p=154
"No child psychiatrist would look at those symptoms and say "autism!"
Joseph, in the Banks case, the child did get a diagnosis of "autism" - from a pediatrician, Dr. Kartzinel. Dr. Kartzinel later explained that he used the term autism as "a simplification for non-medical school personnel" and that technically the correct diagnosis would be "pervasive developmental delay." The special master interpreted that as meaning PDD-NOS under the DSM. But another pediatrican diagnosed Bailey with "global developmental delay with autistic features as opposed to an actual autistic spectrum disorder."
Bailey's neurologist, Dr. Lopez, diagnosed him with developmental delay secondary to ADEM, and said it wasn't autism. I interpret what he said as meaning that if you have a demonstrable brain injury that interferes with development, you wouldn't call that autism. By analogy, if your child had a traumatic brain injury from, say, a car accident, you wouldn't call that "autism" even if the neurological consequences produced behavior that met the diagnostic criteria for a pervasive developmental disorder. You wouldn't say that car accidents cause autism.
So the neurologist saw the injury as sequelae of ADEM, not autism, and it may be true that a child psychiatrist wouldn't have diagnosed Bailey with PDD-NOS on his symptoms. But Dr. Kartzinel the pediatrician did. He gave Bailey an autism diagnosis for school.
I don't think it would be accurate to interpret Special Master Abell's use of the term "non-autistic developmental delay" in the caption of the decision as meaning "not an autistic spectrum diagnosis." I say that because the special master took the time to harmonize a diagnosis under the DSM with neurological sequelae of ADEM, concluding that the two were not mutually exclusive. All he was saying, I think, was that a pediatrician's diagnosis of autism (that really meant PDD-NOS) wouldn't rule out a finding of ADEM resulting in developmental delay.
Anyway it warms my heart to see JB Handley and all the folks at Age of Autism and Evidence of Harm finally conceding that all the ASD's are "autism." Maybe they'll finally stop complaining about all the people on the spectrum who refer to themselves as autistic.
"Hunter... My Hero... My Soldier... My Son".
http://www.youtube.com/watch?v=6OdowdMXONM
Go to bed, Kevin, it is past your bed time.
HCN, I don't have a bed time. I don't sleep very much. I Really mean that, I don't sleep much. I just can't sleep. When I lay my head on the pillow...it's like the Billy Joel video "pressure" going off in my head.
You're the one that needs to go to sleep.
How do you sleep when chidren are suffering from?
Generation Rescue has the money for expensive advertising, but they couldn't fund real reasearch. Instead they whine about how the "Medical Establishment" won't investigate their claims. Sounds like the the IDiots at the Discovery Institute.
RFK jr is a real mendacious hypocritical piece of work. Remember his NIMBY attitude to to an offshre wind turbine project?
If JB and Generation Rescue were interested in diabetes, no doubt they would campaign that all new formulations of insulin be tested against placebo insulin.
Handley brays,
"1. We want the world to know that you can recover from autism, or at least improve meaningfully, with biomedical intervention."
The only factor you can actually claim as being responsible for having improved children under the "care" of DAN! quacks is TIME.
"2. We want to prove that biomedical intervention works and optimize the treatments. We want to know why certain interventions work better for certain kids. (We reject the absurd notion of "spontaneous recovery")"
Bradford is confusing spontaneous with instantaneous. Poor little moron.
"3. We believe vaccines are serving as a primary trigger for kids who experience regressive autism, and we want the world to know this. We continue to receive case reports every day to support this position, and its not an underestimation that we have heard from tens of thousands of families with the same experience. We will fund the scinece to help explore this assertion further, as none of it has yet been done (see below)."
Here comes the fiction. Here comes the confusion of belief and science. Here comes Handley.
"4. We believe the vaccine schedule needs to be changed in the following ways:"
Holy crap, that's what we need, some scientifically ignorant venture capitalist running around injecting his desperation- and anger-infused misinformation into a public health policy.
This is Kevin Champagne in 2005:
I wasn't referring to the Banks case, but to the laundry list of ADEM symptoms, which JB Handley claims are typical in autistic children. They obviously are not.
BTW, is that Dr. Kartzinel from Jenny McCarthy and "autistic children are soul-less" fame?
Whether Hannah Poling and the Banks child are autistic, have "autistic symptoms" only, and borderline autistic, and so forth, does not matter in the grand scheme of things, in my view.
Look, the VICP is very generous to petitioners. They have awarded about 2000 claims. It's statistically impossible that none of the 2000 will be autistic, beyond the fact that encephalopathy may present symptoms that match to some extent those listed for DSM-IV autism.
There will probably be a case like this once a year or so.
And do you have any evidence to reject spontaneous recovery? Considering that it's been observed and documented many, many times? No, you don't. That is equivalent to rejecting gravity.
Beyond that, the sheer hypocrisy of these two points combined is staggering. If you want to prove it works, then by definition you don't already know it works, so #1 necessarily means "we knowingly and deliberately want to lie to the world."
The world does already know that you believe this. The rational world also knows that the assertion has been exhaustively explored already, with the overwhelming weight of evidence being against it.
Great way to promote disease.
Even better way to promote disease in the very young, who are often most vulnerable. Note in particular that the accepted schedule is accepted precisely because it provides protection from deadly diseases at the time when it's needed!
Precautionary rules that are backed up by evidence ARE already generally accepted and used.
JB HAndley:
"Acute disseminated encephalomyelitis (ADEM) is characterized by a brief but intense attack of inflammation in the brain and spinal cord that damages myelin â the protective covering of nerve fibers. It often follows viral infection, or less often, vaccination for measles, mumps, or rubella. The symptoms of ADEM come on quickly, beginning with encephalitis-like symptoms such as fever, fatigue, headache, nausea and vomiting, and in severe cases, seizures and coma."
David, please show these symptoms to any and all parents of children with autism you know. I would guess that MOST had a child who experienced something like this or worse.
This is utterly ridiculous. I'd guess *all* parents of autistic children have seen these symptoms. As have all parents of non-autistic children.
Was there *ever* a child not suffering from fever, fatigue, headache, nausea and vomiting?
JB, with due respect to your good intentions, it is very difficult for non-physicians to look at a list of symptoms and understand what they mean, in terms of what a patient with the condition would look like.
A patient with ADEM looks dramatically different from a typical autism patient. To any neurologist, they are not mistakable.
ADEM is exceedingly rare. A recent pediatric practice survey in Canada estimates the incidence at approx 2 per million (Neurology 2009 v72(3)p232).
It is lunacy to suggest that the prevalence of autism diagnosis (approx 1/150 children in US) is related to ADEM.
It is also lunacy to suggest that halting vaccines would reduce the incidence of ADEM. It is more likely to follow viral infections than it is to follow vaccines.
"There will probably be a case like this once a year or so."
That sounds about right, maybe once every two years. Kathleen found a dozen of them in 20 years.
So, since a DAN! doctor diagnosed Bailey Banks with "autism" after his ADEM, we are supposed to believe that ADEM (presumably all caused by vaccines) is now the cause of autism? Or even a significant cause of autism?
I'd like Mr. Handley and others who think this is so to peruse this case report. It's not the best written, but it is succinct and includes a couple of MRI images.
Now, if that clinical course sounds like what your "autistic" child went through, I think that you have the wrong diagnosis.
I might also point out that ADEM has very characteristic MRI abnormalities, while autism has no MRI abnormalities (and certainly not diffuse demyelination). I'll be generous and say that the advertisment by GR was "uninformed by current scientific/medical knowledge". Others might not be so gracious.
I'd also like to call parents' attention to the list of typical causes of ADEM: measles, mumps, rubella, influenza, parainfluenza, mononucleosis (EBV) and mycoplasma. Most of these are vaccine-preventable. Three of them are prevented by the MMR vaccine.
Even if Bailey Banks' ADEM was caused by the MMR vaccine - which has not been scientifically demonstrated - the risk:benefit ratio still tilts strongly in favor of vaccination.
Given the drop in MMR vaccine coverage in the US and UK, we should expect to soon see a corresponding rise in ADEM caused by wild-type measles, which causes ADEM in 1 out of every 1000 or so patients. Most of these children suffer only mild permanent deficits, although about 1 in 3000 or so are permanently severely disabled.
So, even if the MMR vaccine causes ADEM, ADEM is not autism and would never be confused with it by a competent physician. And, by not vaccinating children, we raise their risk of having ADEM from measles alone from the 1 in 1 million (postulated risk of ADEM from the MMR) to 1 in 1000 - a thousand-fold increase in risk.
You do the math.
Prometheus
Gentleman:
It's a distinct pleasure to blog amongst such distinguished, anonymous, crass, insulting "scientists."
That said, I will make several points that demonstrate how much bullshit many (but not all) of you are full of.
Scientists lose their benefit when they lose their connection to the real world, as many of you appear to have done, so I'm going to ground my discourse in a real world example:
A mom has a 2 month old child. Like 90% plus of parents, she takes her child in for a 2 month "well baby visit" with her pediatrician. At this visit, her 2 month old receives the following vaccines: Hep B, Rotavirus, DTaP, Hib, PCV, Polio, and Flu. That's 7 vaccines in approximately 15 minutes. This happens every day in the U.S. In fact, it's probably happened several times just since I wrote that sentence.
After the appointment, the child appears listless, disoriented, nauseated, and can't stop crying for several days. At her pediatrician's recommendation, she gives Tylenol. 3 days after the visit, her child develops eczema. A week later, the crying has stopped, but the child's gaze appears more distant, according to the Mom.
A year goes by, Mom keeps vaccinating, the child hits 14 months, and is diagnosed with autism. (That's about as early as you can get a diagnosis)
Now, the Mom pieces the whole history of her child together and starts to suspect itâs the vaccines, and she keeps going back to that 2 month visit where things really changed.
You, one of you many anonymous, crass, arrogant jerks, is now her new doctor. You need to explain to her that it's not the vaccines. So, which scientific study do you pull out first? And, I'll give you some choices:
- Do you pull out the CDC study that compared fully vaccinated children who had received more and less thimerosal in their vaccines? (and reached a non-conclusion?)
- Do you pull out the Danish study that compares Danish children -- all of whom received considerably fewer vaccines than American children-- who got all their vaccines with thimerosal and all their vaccines without thimerosal?
- Do you pull out the studies of children who received all their vaccines except MMR?
Which one of these studies answers definitively to this mom that the 2 month visit and attendant problems was a figment of her imagination. Which one?
So, here are 2 truths that the honest members of this forum will have to agree with, no matter how they may feel about who is writing this:
1. Anyone saying, "It's been asked and answered, vaccines don't cause autism" is categorically lying.
2. The honest questions, to get honest answers, have never been asked. Science can easily be hijacked and abused by asking an unhelpful question, answering it, and then claiming the study actually answers something else. In the community of scientists, some of whom read this blog, that has been done repeatedly on this issue. You have no science to answer this Mom's concerns, it doesn't yet exist.
In that way, I think the CDC and others have done an extreme disservice to honest doctors and scientists. By not asking the hard questions, and facing potentially hard answers, they leave themselves open to extreme criticism.
I also need to point something out to all of you that many of you seem to deny: the vaccines programâs rate of adverse events is only acceptable if autism isnât one of them.
Now, Iâll be the first to admit that the right science, given the extreme complexity of administering seven vaccines in 15 minutes to a two month old, is very, very hard to create or study. This is part of why we are in this pickle - both sides feel that they are saving children from harm, for very different reasons, which haven't yet been studied. Moreover, the ethical considerations become insurmountable if you are withholding lifesaving vaccines from children who would have otherwise received them.
But, viewing the problem as extremely complex does not give science an excuse to run away. The parent complaints are not stopping, our community is growing, our resources are growing. We believe the vaccine program IS creating an adverse event rate of 1 in 150 or higher, so we will continue to fight like hell. To think that getting to an honest answer is in any way an even playing field is delusional, becuase the vaccine program will be defended by many at any cost.
The honest scientists will join us in conceding what has not yet been done to answer the concerns of parents and what needs to be done. Some ideas, far from exhaustive, for science that could be done to explore the concerns of parents further:
1.Do appropriate blood work and an MRI on 1,000 children who are 11 weeks old. Give them 7 vaccines at their 2 month well baby visit. Do a follow-up MRI the next day and 3 months later and all the blood work. See what you see.
2.Study unvaccinated kids. Now, I read Prometheusâ post about confounders, and I found a fatal flaw in his argument: the CDC âestimateâ that 0.3% of children are completely unvaccinated is complete and utter bullshit. If you just spent time in California or Oregon, youâd realize there is closer to 5-10% of kids completely unvaccinated. We have some counties in Oregon where the number is upwards of 15-20%. So, kids who otherwise live the same lives could be found next door to each other. To imply that other confounders will be so severe as to muddy the waters is just speculation.
3.Study the biology of children who experience regressive autism, as characterized by their parents and doctors, and examine all biological markers to try and establish differences from controls and the origin of the differences.
4.Go to countries where the schedule of vaccines is materially different and study outcomes of a wide variety of things like: autism, asthma, diabetes, etc.
5.Use animals that most closely resemble humans and do a vax/unvax study on them: give one group the first 2 years of our schedule, give the second group absolutely nothing, and see if there is any difference whatsoever in neurology or otherwise. These animals would need to be monitored for a minimum of 3 years.
Are any of these good ideas in the abstract? Probably. Are some better than others? Indeed.
Hereâs one thing that is true:
They all beat the living shit out of the unbelievably clear lie that science has already spoken on this issue. Itâs unreasonable to be exasperated that guys like me are still talking about this issue when nothing honest has been done to address it.
Any of you calling your self scientists who have ever uttered the words, âthe science has shown that vaccines donât cause autismâ or anything near that should immediately step away from your computer, walk into your back yard, and yell, for all your neighbors to hear, âI am a fucking moron!â
With love,
JB Handley
"Kathleen found a dozen of them in 20 years."
Actually, I found nine published decisions of that sort over the history of the Program (and that was after a day spent combing through about one hundred returns on Lexis searches of VICP decisions containing terms like "autis*," "pervasive developmental," "mental retardation," etc. (I misremembered the number as seventeen in earlier comments.)
There are probably similar instances of compensation awarded to vaccine-injured children with ASD and MR diagnoses in unpublished decisions (i.e., nonprecedential decisions that, although public documents, are not sent to legal publishers), including stipulations that include little discussion of the factual record. To research this, one would have to go in person to the courthouse in D.C.; the archive of unpublished decisions on the Court of Federal Claims website only goes as far back as 2004 or so.
Children with ASD and MR diagnoses and children without them have been and will continue to be awarded compensation if they can establish that it was more likely than not that they experienced a vaccine injury. That takes contemporaneous records and credible corroborating testimony, not just shaky causation hypotheses, piles of Unigenetics or Doctor's Data lab reports, and expensive publicity campaigns.
There are a number of adverse consequences from catching a natural infection. Take mumps for example. Up to 15% will have meningism/meningitis (inflammed lining around the brain which causes headache and neck stiffness and fever). It is usually mild and settles without sequelae.
Mumps vaccine (in MMR mark I) used to cause this. Some strains (Urabe) were associated with causing this meningitis in between 1:4000 and 1:11000 doses of vaccine. It no longer happens with MMR mark II, which uses a different strain.
What do the antivax crowd do? They scream blue murder from the rooftops about how MMR causes mumps meningitis, calling it "serious neurological damage". When it is pointed out to them that the natural "harmless" infection causes the exact same thing, but 1000x more commonly, they go very quiet and change the subject, or call the naturally-occurring meningitis "entirely harmless", well, because it is "natural".
ADEM is in the same category. Natural measles (or mumps, or rubella) can cause it, as we can see. And it can also be caused by MMR vaccine, but the risks of this are several orders of magnitude less than the risks from getting it from the naturally-acquired infection.
The deliberate twisting of these facts to suit an antivax agenda is unfortunately something we will see again and again. These people have no shame, no integrity and no ethics or morals. They will knowingly and deliberately risk exposing their own (and our own) children to harm, all for the sake of maintaining the lie about vaccines.
Thanks for the MRI data Prometheus.
Looks to me as if there are three lies wrapped up in this GR advertisement:
1.ADEM leads to autism in Bailey Banks or anyone else. GR is lying about the decision handed down.
2 ADEM could contribute to autism prevalence. It can't because at 1-2 per million it's too rare.
3 ADEM has a unique MRI profile that autism does not have and that salient fact will not be found in the ad.
Surely there are consequences for false advertising to the Americal public aren't there?
What do you want to bet Handley is sending someone out to this as we speak? Maybe they can use it after the decision of the thimerosal-only cases in the Omnibus. They can then claim there were a bunch of "hidden" cases.
Or maybe they'll just lift another of the ones you have listed in your blog post, Kathleen.
They will knowingly and deliberately risk exposing their own (and our own) children to harm, all for the sake of maintaining the lie about vaccines.
I don't think that they're lying, but rather that they genuinely believe that "natural" ADEM is much less harmful than vaccine induced ADEM. And I think that the believing and spreading the idea that "natural" must be less harmful than artificial is likely more dangerous than lying about one specific health issue.
It's a distinct pleasure to blog amongst such distinguished, anonymous, crass, insulting "scientists."
Anyone else find this line oddly ironic? I mean, it does describe AoA pretty succinctly. I guess they aren't "anonymous".
But, JB Handley complaining that someone else is crass? And, wow, what a bunch of pseudoscientists he has enlisted. When Mark Blaxill is king of the hill for science, you are in pretty deep into the world of "scientists" with quotation marks.
JBH: "...step away from your computer, walk into your back yard, and yell, for all your neighbors to hear, âI am a fucking moron!â
Fortunately for you, JB, your neighbors are out of earshot. At least you have the internet.
Mr. Handley, in your latest spittle-soaked tirade you wrote:
But just yesterday in Lisa Jo Rudy's about.com blog you wrote:
(30) JB Handley says:
Sandy:
I donât believe all cases of autism are caused by vaccines.
Iâm acknowledging this fact.
You may want to ask Baileyâs parents if he has autism before trying to argue he doesnât, IMO.
JB
http://autism.about.com/b/2009/02/25/autism-activists-launch-media-blit…
Question: How do you estimate a vaccine injury rate of 1:150? Isn't that also the CDC's estimate for the prevalence of ASDs?
JB - did you not read the Omnibus rulings? All the stupid 'science' is right there with you asshole. Do you understand that people have finally caught on to your lying adverts?
Do you realise that all of us know that the surest way to tell that you are rattled is when you start commenting on a blog that disagrees with you?
Is Jamie cured yet? You know he should be. Four years ago you said he'd be cured in two. You said he'd be 100% neurotypical, indistinguishable from his peers. You said all autism was mercury poisoning and you had the cure.
You're a stupid, lying moron.
JB--
The flu shot is not given at 2 months old. And I'm sure you know that.
If you're going to make forays into science, you better start by getting your basic facts right.
BTW, "the vaccines programâs rate of adverse events is only acceptable if autism isnât one of them"
-->only if you consider morbidity and mortality from infectious diseases to be preferable to autism. Do you agree with this?
"What do you want to bet Handley is sending someone out to this as we speak?"
Well, if the job's already been done, which may well be the case, it wouldn't be necessary to do it again. It's a fairly small world of attorneys who specialize in VICP, and a number now practicing (and representing numerous autism clients) have done so since the Program's inception. It's likely that most instances of compensation to vaccine-injured individuals with ASD or MMR diagnoses are already known to members of the Petitioners' Steering Committee. It would seem to make sense for one or more of them to have undertaken a comprehensive survey as part of Omnibus preparations.
Although as Prometheus points out, one would certainly need a very large study population to detect a 5 or 10% increase in autism risk, the antivax people are arguing that vaccination is a large hazard, so it should be detectable in a study of reasonable size. A more serious problem would be bias. The population of people who choose not to vaccinate will be heavily weighted toward those who have a specific reason to fear autism, such as autism in the family or a previous autistic child. Since we know that autism has an extremely strong genetic component, this population should have an elevated incidence of autism even if there is no additional risk associated with vaccination.
However, I think there is a study design that would get around this. The idea would be to look for families with more than one child, of which one is autistic, and study the other children with respect to correlation of autism with vaccination status. There are still some potential confounds. One would have to exclude partially vaccinated children or children vaccinated on a nonstandard schedule, and it would also be necessary to control for possible birth order effects (since parents who already have one autistic child may be more likely to fear vaccination). Nevertheless, if there is a strong risk of autism associated with vaccination, such a study should pick it up.
I'm sure that it would be possible to find qualified epidemiologists to do such a study if funds were available. But I'm doubtful if such a study will ever be done. I can't see why NIH would fund it, because from the standpoint of medical science, there is already more than adequate evidence to conclude that vaccination does not carry an appreciable risk of autism. Better to invest public funds in research that actually has a chance of helping people with autism.
Of course, Generation Rescue and the other antivax groups clearly have the financial resources to fund such a study. But I can't see why they would want to do so, either. After Generation Rescue's earlier survey, they probably have a good idea that no increased risk of autism will be found, and it might even turn out that failure to vaccinate increases the risk of autism. Organizations tend to perpetuate their own existence, and if the public actually becomes convinced that vaccinations don't cause autism, then what will happen to all of the donations from parents, rich celebrities, quack doctors, and autism-case lawyers? What will happen to the jobs of all of the people who work for Generation Rescue and Autism Speaks? Far better not to risk killing the goose that lays the golden eggs....
I think we're missing a lovely (inadvertent?) disclosure that JBH handleyed us: the real agenda.
Somehow, one way or another, get the VICP to award a million or so in compensation to every child in the USA with an autistic spectrum disorder. Say goodbye to the VICP, because at 1/150 times 21 years (birth to statute of limitations) that comes to over $560 billion. Yup, you read that right.
At which point the price tag for every child vaccinated goes to about $7000 just for the "vaccines cause autism" liability. No manufacturer is going to go near that business, so at that point the USA goes vaccine-free and Jenny et al have accomplished their lives' ambitions.
But lookit all them needles in the photograph in the Generation Rescue ad! Needles are _scary_! Addicts use them! Foreign substances are introduced into your body by government order! It must be BAD!!!
Not as horrific as the images of children afflicted with preventable infectious diseases on Peter Bowditch's website, but still...needles...pointy...penetrating...very scary, if you're Jim Carrey.
Well, well, well...if it isn't Reaction-Formation personified, Mr. Handly.
What's the matter? Tired of getting your nuts stomped on in the court and science arenas that you decided on a change of venue. Come over here, and purposefully stir up a veritable round-table of ad hominem. You are quite the attention seeking masochist, ain't ya?
Well, everyone needs a hobby I suppose. Let me know how that goes for ya.
Now scamper off to AoA, engage in your usual self-aggrandizing behavior, and get that spotlight back on yourself (even though it's your own spotlight).
Cuz, really, you are a man to be ignored.
Aaaaand there's already a retailiatory post on Age of Autism.
So painfully predictable.
Mind you, in their favour, it was also predictable that someone would post that here too.
Wow, I've got to admit, that's probably the slickest excuse I've ever seen for ignoring the data and cherry-picking one anecdote. Too bad for JBH that a slick excuse is all it is.
You obviously got those numbers from your phone survey, JB. The 0.3% number comes from a published survey that didn't have the selection bias your survey had. Of course, it's possible 0.3% has changed (thanks to you in part).
For anyone wondering what I'm talking about, this is how the automatic introductory message of the GR phone survey read:
Obviously, anti-vaxers were much more likely to continue with the survey, thus inflating the numbers of unvaccinated children. SurveyUSA must have made a humongous number of calls that were fruitless.
An interesting observation about this is that 3.73% of all fully unvaccinated children were reported to have an ASD diagnosis. How is this possible? Were parents who have fully unvaccinated autistic children that much more likely to continue with the survey than parents who have fully unvaccinated children who are not autistic? Doubtful. I've suggested there's a genetic explanation for it.
2-month olds with flu shots? Jeebus JB, get help.
You tilt at windmills because you refuse to accept that you probably have the autism genes. You're stuck in denial.
If the rate really was 1/150, then you wouldn't have had such a heck of a time coming up with decent data to support this. But the truth is you're desperately looking for a scapegoat. First it was MMR. FAIL. Then it was mercury. FAIL. Now it's the vague and untestable "vaccines". Which vaccine? You finally got wise enough not to specify, which enables you to sally forth with your circle jerk indefinitely.
Hi Orac,
I think it is important to acknowledge the great public service that Mr. Handley does each time he makes any statements about autism or vaccines. For simplicity letâs just look at his 1pm posting here from the 26th.
Mr. H. says: âautism is impacting at least 1 in 150 childrenâ
Wrong, after all this time he canât even get the number correct.
Mr. H says: âThe Court's purpose is to uphold the vaccine programâ
Wrong, after the court systematically demonstrated the absolute falsehood of everything that Mr. H et al argue, their response was to simply make things up. This claim is an out right fabrication, just like the claim that there was no discovery, just like the claim that the petitioners were refused access to the VDS. Fortunately any person of integrity can go to the courtâs site and read the truth and see how AoA has been systematically untruthful about the decisions.
Mr.âs comments about recovery are just bizarre. Hello, the expression is developmental delay! Despite 70+ years of data of kids with autism getting better as they ageâsometimes to the point that they no longer have autismâsome parentâs just arenât smart enough to figure this out. Kind of convenient for conmen who lie about the prognosis, sell the snake oil and then take credit for when the kid simple develops as expected.
Mr. H says: âWe continue to receive case reports every day to support this positionâ
Even ignoring the abject failure to follow the basic logic or biology in this argument, the fact is we have 30 years of videotaping kids with autism that proves this argument is false. Worse, it is matter of public record that Mr. Hâs allies have actively sought to hide this data from families affected with autism. They have actively attempted to deceive families with autism.
Mr. H makes a number of suggested changes to the vaccine schedule completely ignoring the developed counties data that these changes will kill children. Unsurprisingly his suggestions have been completely rejected.
Mr. H says: âAs you well know, the only vaccine that has ever been studied in terms of its relationship to autism is the MMR.
Wrong again, fortunately any person with even the most modest literacy skills can figure out that you are not telling the truth.
Mr. H says: âYou also know that vaccines have NEVER been tested for combination riskâ
And again wrong. There use to be this naïve idea that if these studies were posted on-line that people like you would tell the truth but nope, no matter how many years go by you just canât get the simple facts correct. Once again, any honest effort will easily prove that your argument is not true.
Mr. H. says: âYou also know that every "scientific" study of any relationship between thimerosal and/or MMR has ONLY ever looked at vaccinated kids.â
Wrong again, after 8 years of walking the Mr. Hâs of the world through the data on autism risk in 100% unvaccinated kids vs. vaccinated kids, I think it is pointless to expect them to be truthful. Of course the reason why they have to claim the nonexistence of this data is because there is no difference in risk between 100% unvaccinated and vaccinated or partially vaccinated.
The very ugly truth is that AoA has to resort to calling everyone a liar and make personal attacks on peopleâs excretion/sexual functions is because they are unable to formulate an argument that doesnât insult the intelligence of the average high school student.
The sum effect of Mr. H/AoA/GenR etc has been to marginalize the organizations as incompetent and dishonest and subject its members to ridicule and contempt.
Fortunately they are mostly harmless. Once a person is willing to accept the possibility that Mr. Hâs arguments might not be trueâand thus bothers to double check the basic factsâone finds that they are not so much wrong, as mind numbingly, dumb as rocks, idiocy
âConsider this: If the proceedings are so rigged against the petitioners, why is it that the U.S. government pays their legal fees?â
Orac consider this: Cuz itâs written in the law that way. Duh!
I think any *reasonable* individual would understand that RK Jr. was talking about âriggedâ as in denying compensation for the ACTUAL plaintiff â you know, the child that got injured.
Kelli Ann Davis
DC Political Liaison for Generation Rescue AND a big JB Handley supporter!
Eat your heart out!
Kelli,
So, not having to pay a huge cash retainer upfront (because the attorneys are guaranteed payment) isn't an advantage to families who couldn't otherwise enlist quality legal council?
Couldn't GR afford a less dumb political liason? Like someone that at least knows that lawyers cost money.
Except that J.B. knows I'm not "anonymous." Rather, I'm pseudonymous. In fact, he's proven time and time again that he knows who I am, even very, very recently; I daresay at least 25% of my readers probably know who I am too, and those who really want to find out could probably do it if they wanted to.
As for crass and insulting, talk about a case of the pot calling the kettle black. J.B. is the very definition of crassness and he loves to insult people he doesn't like. He also seems to think it bothers me when he lobs insults about at me, either as Orac or as the "real me."
JBH said: "Children in general need to receive fewer vaccines. Reduction can come in two ways: eliminating certain vaccines like Hep b (except when Mom is positive) and Flu..."
If you think I'm going to not vaccinate my preemie against the flu you are insane! Why do anti-vaxers think the flu is this harmless little bug?
Hi Kelli Ann Davis,
Kirby and Kennedy (and seemingly you) assert that the vaccine court was rigged against the petitioners. So letâs look at the facts. This is the essence of your position right? That we the people shouldnât just accept arguments, but rather that we should research and decide what is true for ourselvesâcorrect?
The court has posted a lot of files on its siteâthis is rather convenient. So when K&K state that petitioners were denied the opportunity to see the VSD we can read how this is simply not true.
So when K&K state that there was no right to discovery, we can ready the discovery process and follow the 100,000âs of documents obtained through discovery from industry and government. Etc, etc
In short Kelli they are simply wrong. Wrong in the sense that they what they say is entirely untrue. The very ugly truth is that when the 3 decisions came down your side simply responded by fabricating reasons not to trust the judgments. I knowâvery, very sick. But fortunately they just arenât very smart. You can easy see how dishonest your side has been.
The only question is will you bother to read the court documents and compare them to what K&K say.
If you do start this process and actually read the documents, there is a big problem for you. Basically everything that K&K, and Mr. Handley, and GenR and AoA etc say are untrue. Untrue in the exact sense that they systematically misrepresent the most basic facts.
Worse for you, once you start looking you will find many instances when these obvious errors have been pointed out and yet they continue to mislead people.
So are you game to try? There are lots and lots of examples.
Even more predictable than you know.
Take the Banks case. Whether the child had ADEM was in doubt. Whether ADEM was caused by vaccination was in doubt. Whether ADEM is associated with PDD was not only in doubt, but there's absolutely no published evidence that it is. The Special Master at one point had to argue that Daubert does not apply in the VICP.
And yet, the Special Master ruled in favor of the plaintiff, because he felt the plaintiff had a better case than the respondent, based on expert testimony - that's preponderance of evidence.
So how is the VICP rigged against plaintiffs again?
This is what JB Handley said to Kev once:
I'd say he's being a bit disingenuous.
I believe JB Handley has impure thoughts about crazy Dawn.
Gross. He should stick to the goats.
As expected,
JB, a quick way to earn just a tad bit more credibility with anyone, when you make statements, as you do, particularly if they are in contention with what another has said, cite your evidence. You never do that (and, as a result, no one takes you seriously).
From an earlier post (sorry, I didn't see your response):
JB: " While you say the burden is on us to do studies to change the schedule, where are the studies that show this many vaccines are safe? How come they don't test vaccines for combination risk, even though that's the only way they are administered? Why is that OK with you?"
Who do you think "us" is? As if you've got some patent on being an autism "victim"? Everyone, including those in medicine and the scientific field also have children/friends/family members with autism. Sorry to shatter your martyr complex, but it affects everyone the same way. It's OUR vested interest, not yours. Secondly, again, if you think those studies would help alleviate your predilection on those specific topics, again, do something about it! You are in a position of authority and should be leading the charge, not sniveling that someone isn't performing the worthless studies you deem of value and producing the results you want to see. Do something other than cast blame.
"where are the studies that show this many vaccines are safe? "
For how long and with how many individuals has this schedule been used for? Not enough?
Are you actually aware of the studies that are done? Just how many studies do you think have been performed? Which studies are you aware of? Why not call some of these clinicians conducting current trials and ask them why your "studies" are, in fact, worthless. Ask the thousands of people who are involved in the research.
http://www.clinicaltrials.gov/ct2/results?term=vaccines
Studies are conducted all the time. And, NO! They have never found autism to be one of the side-effects. Talk to them instead of at and about them.
What an excellent suggestion, RJ. Mr. Handley, at AoA they often bray about how vaccines are never tested in conjunction with other vaccines. That is demonstrably false, for example, one of the studies in RJ's list:
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
See, they are looking at whether this specific vaccine, the Novartis Meningococcla B Recombinant is: a) effective b) safe and c) consistent between different lots, when given to infants already receiving the routine schedule.
Pubmed will reveal hundreds of such studies.
742 for concomitant vaccine
133 for concomitant vaccine infant
Take a look at some of these. Contact the authors with your concerns.
"Orac consider this: Cuz itâs written in the law that way. Duh!"
......and now think about who brings in laws, and who enforces them. You'd be suprised, I assure you.
Hint: The word begins with a 'g' an 'o' and a 'v'.
Orac is still correct, with legal fees being paid by the gubmint, lawyers can bring cases with little risk of loss and petitioners are systemically supported above and beyond what is normally expected in the normal courts.
JB and Kelli Ann,
First, I think it's great you are able to come here and state your perspectives and opinions (willingly and freely). Many of us have been blocked from some of the forums you sanction, probably for saying things you don't want to hear.
I am going to go out on a limb here and suggest that the consensus here (correct me if I am wrong ladies and gentlemen) that you are unaware of 1) the facts surrounding vaccines and vaccine trials 2) the fundamental concepts associated with the immunology, toxicology, pharmacokinetics, psychiatry/psychology, and the scientific method 3) the cold hard facts and 4) you are unaware of or deny the fact that you simply do not know (you are assuming you know what everyone else does).
We understand your concerns. Our children are important. We want to ensure safety to the best of our ability. But igonorance can lead to dissaster, especially when people are attacking one of the foundations of our public health system based on ignorance.
Now, perhaps you will be taken back by the word ignorance, but I would ask that you don't; we are all ignorant at some level. So, I would suggest, from someone on this side of the discussion that you talk to some of the actual clinicians in trials and find out the real story. Many of these people have participated in many of the studies you claim have never been done (when, in fact, they have). Talk with these people. Expose yourself to the information that is available and then share it with the others. Stop perpetuating a campaign based on ignorance.
A selection of trials involving pediatric vaccines:
http://www.clinicaltrials.gov/ct2/results?term=vaccines&recr=&rslt=&typ…
BTW, your beef with anonymity on websites...I don't know where you got the idea that people are supposed to put their full names on message boards, but from personal experience, when AoA put my personal info up on their board, including an address and phone numbers, I received phone calls all week long. There are appropriate formats and channels for all discourse. Internet webpages hardly need to be formal and, based on my personal experience, for safety reasons I do not recommend it.
Why do you think cranks complain so much about anonymity? If they can't win the arguments, they've found they can at least harass their opponents. In extreme cases, they will even attempt to chill discourse through legal bullying.
JB or Kelli Ann,
Can you tell us how much Generation Rescue has contributed to bona fide vaccine safety research vs. advertising?
Generation Rescue Revenue/Expenses (from Form 990)
2005 REVENUES $530,495
Expenses
Consulting $20,000
Supplies $1,544
Printing & publications $316
Conferences & meetings $13,720
Travel $2,885
Meals $268
PR & Advertising $347,335
Google Ad Words $110,078
TOTAL EXPENSES $496,146
2006 REVENUES $318,695
Expenses
PR & Advertising $108,365
Google Ad Words $11,550
Market Research & Survey $232,500
Supplies $353
TOTAL EXPENSES $352,768
2007 REVENUES $425,317
Expenses
Advertising $264,260
Market Research $156,292
Website Maintanance $3,418
Bank Fees $728
TOTAL EXPENSES $424,698
2005-2007
TOTAL REVENUES $1,274,507
Expenses
Advertising $841,588
Market Research/Survey $388,792
Consulting $20,000
Conferences/Travel $13,988
Office & Bank Expense $2,941
TOTAL EXPENSES $1,273,612
RJ:
I will respond politely to your polite email. I have actually followed many of the links you have provided.
Here is my question to you, because I couldn't find it anywhere:
At 2 months, children receive between 6 and 7 vaccines (if the doctor gives flu, which they often do) based on CDC's schedule. Where is the testing that shows one group of children who get all the vaccines and one group of children who get none? The none group could also get a placebo. This is how drug trials are done.
If, however, children receiign 5 of the vaccines are compared to children receiving those 5 and the new sixth one, that's not really a clean test, is it?
When you find this study, please email it to me, and I promise to never again say vaccines aren't tested for safety in combination. Since I just can't check back here often enough, here's my private email where you are free to send it: jbhandleyjr@gmail.com
Many thanks, JB
Yup. Just as expected...all bark, no bite. 2/3 of their budget on advertising. A self-feeding machine. Bring in more money by advertising, so you can advertise more. What a nobel endeavor.
pretty cool to be rich enough to morph your rage and lust for revenge into a big fat tax write-off
There should be a tax penalty for endangering public health.
"We want the world to know that you can recover from autism, or at least improve meaningfully, with biomedical intervention."
"We want to prove that biomedical intervention works and optimize the treatments. We want to know why certain interventions work better for certain kids."
Yet, apparently, 0.00$ from Generation Rescue has funded any real scientific research for biomedical intervention for autism to deliver such knowledge.
"We believe vaccines are serving as a primary trigger for kids who experience regressive autism, and we want the world to know this."
"We will fund the scinece to help explore this assertion further, as none of it has yet been done."
"We believe the vaccine schedule needs to be changed in the following ways:"
Yet, apparently, 0.00$ from Generation Rescue has funded any real scientific autism research, or any scientific research for vaccine safety (or actual schedule changes).
Given those stated goals, what do you think about the probability that Generation Rescue could be utterly failing its donors, JB?
Every time JB or Kelli Ann post those figures should be re-posted in response and ask them how much revenue is going towards their stated goals.
Over and over.
Eventually their donors will start asking the same question.
Consistent with the average life expectancy: 3/4 of diagnosed Autistics are over the age of 18. Prior to the 90s they were a 'hidden horde'; there is no evidence on an actual massive increase of Autism, it has been stable for as long as we can tell.
The failed vaccine hypothesis/conspiracy theory stands on the pillar that there has been such an increase Mr Handley, that most diagnosed Autistics are children, or were before 1994. Most of this increase is because of Asperger's Syndrome; a diagnosis often mocked among your own grubby little hordes of hysterical loons and not fitting with the stories they tell about their children.
No, it's not, at least in some cases. I participate in the design drug trials; I know.
There are a fair number of circumstances when it is unethical to use a placebo control group. Read the Helsinki Declaration and the Belmont Report, which are two of the major documents that lay down the ethical precepts of modern clinical trials. Specifically, from the Helsinki Declaration, with only very limited exceptions and only with extreme justification both scientifically and ethically, a placebo may not be used unless no current proven effective intervention exists for the condition under study. That is not the case in vaccine trials. Proven effective preventatives of disease do exist, namely vaccines. It is thus unethical to have a placebo control group in a randomized clinical trial of vaccines. The only exception is when a disease for which no effective vaccine yet exists is being studied.
Before you go pontificating again that this isn't how it's done in other trials, that's just not true, either. In cancer trials, for instance, new drugs are usually not compared against placebos anymore. Rather, they are compared against or added to the best currently available therapy. Ditto antibiotic trials. Ditto trials of many drugs. That does not mean trials can't be done; it just makes them more difficult, and it takes more controlling for confounders to make up for the inability to do RCTs. That's why any trial of vaccinated versus unvaccinated can't be a randomized, double-blind, placebo-controlled clinical trial. Under the Helsinki Declaration, it would be unethical except in the cases of specific diseases for which we do not currently have an effective vaccine.
In other words, it's a misunderstanding of science- and evidence-based medicine man that placebo-controlled randomized clinical trials always have to be done to verify the safety and efficacy. There are many clinical questions for which the use of a placebo control group is impossible or completely unethical. Trials of surgical therapies come to mind. Again, it takes more work to verify efficacy without RCTs.
The bottom line is that you simply do not know what you are talking about when it comes to how drugs are studied. You think you do, but you do not. You do not know science (or you "know" it but reject it because it doesn't tell you what you want to hear); you do not know epidemiology; you do not know clinical trial design; and in particular you don't understand (or, again, you understand but reject) the bioethical framework upon which clinical trial design has been built since World War II. Moreover, it has been explained to you time and time again and is not a difficult concept.
Finally, the Helsinki Declaration requires that human subjects research "must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation." In other words, for a clinical trial to be ethical, one major condition is that the hypothesis being tested must be science-based and founded on sound and compelling preliminary evidence from basic science, animal work, and clinical observations. Your hypothesis fails that test as well.
JB,
At first, I thought you were just careless, but you've claimed that 2-month olds get the flu vaccine twice now.
Apparently you haven't actually read or understood the HHS/CDC Childhood Immunization Schedule, the flu vaccine licensing, the flu vaccine package insert, or Note #6 on the immunization schedule. In fact, you seem to pretty much be full of shit. Why should anyone listen to you if you can't even get the simplest of little facts straigt?
I know the commenter "What?" just wrote about this, but as someone in a local government immunization program, I feel it bears repeating...
The flu vaccine is given to children no younger than 6 months! 6. It's the number between 5 and 7. Giving the vaccine outside of the recommended age for the patient is off-label use and a recipe for liability that no sane physician would want to risk. If there are instances of flu vaccination younger than 6 months, then those physicians are doing it incorrectly.
If you check the CDC Vaccines web page that summarizes the recommendations for clinicians about flu vaccination:
(http://www.cdc.gov/flu/professionals/
vaccination/vax-summary.htm)
you'll see about 8 references to the 6 month age limit (I may have missed 1 or 2 more).
Just to waste a little of my time :-)
Oh, you want to start with attacking people. OK, right.
You would be wise to be warned that this done by bullshitters (e.g. you) tends to have the effect of the shit flying back into their faces.
You have been told many, many time how limited anecdotal examples are.
Gee, if it isn't the "too many at once" ploy. Also, you're "loading" your "argument.
So? Loading the argument again.
Entirely straw-man on too many levels to give them all. In particular, all other possible causes are "conveniently" not mentioned, only the one you are obsessed with. (Note ascertainment bias, etc., too)
Still attacking people, not things presented...
Yes, your choices... (which strangely excludes the obvious: looking closer at the child and asking the parent about what other things were happening to the child at the time, etc.)
Misrepresented: it have a conclusion.
Excusing the errors that render this non-grammatical, so? (You don't make any point at all!)
How about what you left out...? (See above.)
They're not actually. What has happened is that the anti-vaccine lot are moving the goalposts after the fact, and you talking in the same way. The complaint was that "thimerosal in the vaccines", not "the vaccines" caused autism. This has been answered, several times over. You (and other anti-vaccine people) have moved this after the fact to be "any old thing about any old vaccine" (which sounds a little desperate to me).
Now you are categorically lying.
Yes, most usually by non-scientists who want to frame "science" into what they would like to be true. The anti-vaccine groups, and yourself, are excellent examples of this. (I would add it is unwise to accuse others of what you do yourself.)
Also I note that you cast this in terms of conspiracy. Owing to the nature of research science endeavour (as a whole, i.e. in total), this is essentially impossible to happen.
Your loaded example conveniently avoided the very obvious attempts that even a trainee nurse would use. (See above.) The latter clause is just silly, trying to ad hoc dismiss people. You example doesn't even try find out what's up with the kid, so how would anyone if they didn't try look?
Straw-man. Leaves out the reality and replaces it with one from your own imagination.
Rubbish. Conspiracy theories again, I note.
Not true, as others have pointed out.
So? You don't have to compare again placebo.
Straw-man argument again, and silly.
So? If this is the result of scaremongering, then this is hardly something that is positive, nor is it something that "proves" the science has something wrong with it.
Beliefs don't matter a jot. (You can believe cows turn purple under a full moon...) If you want to demonstrate such claim, fine. But until then, saying "We believe..." is not "worth" anything in terms of what is actually happening or not.
Conspiracy theories again. I've already pointed out that this is essentially impossible to happen over science research as a whole. (How do you think that the previous (rare) problems with vaccines have been found and addressed?)
Loaded: 'conceding'. Conceding what from who... There is a huge amount of research on both vaccines and autism already. Whether you like it or not, the vast majority is very honest (the odd blemish like Wakefield's work aside).
Erm, "routine" MRIs on a large number of 2 month old infants. You obviously have no idea of the issues involved (practical and ethical).
Even if you were right, cherry-picking data proves nothing. I could cherry-pick a religious community that generally doesn't vaccinate and even higher non-vaccinated rates.
Already done and more studies in progress.
You obviously don't read the literature.
Ditto: you obviously don't read the literature.
See my earlier point about moving goal posts. Also, you being the "over demanding person": ignoring the large volume of science already present, writing as if none existed and "demanding" more than there already is: something anyone can "demand" forever; it's pointless and done dishonestly, disingenuous.
Yes, it's very exasperating to read someone like you who is still talking about this issue in a dishonest way after so much has been to address it.
Erm, you are the moron, JB. You're welcome to go out and let the neighbour know, as you so kindly suggested that others should. (If you suggest it to others you should be happy to do it yourself...)
But, please tell me, in all of this "in the negative" argument, do you have any evidence what-so-ever "in the positive", i.e. the vaccines cause autism. (Not your belief, not anecdates, evidence.) It's really fun and easy to "demand of others", isn't it JB. You just have to write more-or-less random things. No real effort involved, just a lot of crass writing.
Let's compare that to the many, many research scientists working on autism (and vaccines). It's "funny" how they get "forgotten" in your writing.
The problem with people like that is that they're unaware of the scientific literature and only know what's presented by the mass media. Several years ago, I saw a creationist make what had to be the second most truly mind-bogglingly stupid statement I've ever seen: "if evolution is true, why isn't it the top story on CNN every night?" (the only one that surpassed it was the claim that allowing same-sex marriage would impose a heavy financial cost on societies because all the dictionaries would have to be revised).
ebohlman: I suppose they are at least good for entertainment for some of us. Don't like the cost of their entertainment, though. Other people suffering isn't something anyone should pay for a laugh, etc.
PS: Excuse my many grammar, etc., errors in my previous post: didn't have time to copy edit before posting.
Ah, yes, the old woo gambit of the anecdote, played for maximum irony: "I, in my infinitely infallible godhood know the one way this uncontrolled anecdote should be interpreted beforehand, because I know with 100% certainty the biases I used to interpret it are right. There's no need for the scientific method to eliminate bias, because I know my biases are right."
Here is what I never can understand: what exactly is the goal of those decrying vaccines as harmful? Is it to end vaccination programs?
It would seem to me that, hypothetically, even if the autism-vaccine link could be made (which I see absolutely no evidence for- but what do I know? I'm just an epidemiologist) ending the vaccination program would not be an option. Vaccinations are clearly proven to prevent dangerous and deadly diseases. The risk-benefit balance would still tilt in favor of vaccination. There is simply not a question on the benefits of vaccines (which is why an IRB would never approve a randomized study with an unvaccinated group: we lack equipoise on the benefit of vaccination).
Given the newest proposed mechanisms of vaccines causing "autism" (ADEM and fevers in children with underlying [rare] mitochondrial disorders), ending vaccinations would lead to more cases of autism, not less. Theories on immune overload, etc. are logically unfounded as children are now exposed to fewer antigens and potentially immune defeating agents, thanks to new vaccines and the vaccine driven elimination of small pox. Additionally, vaccinations given at the same time garner similar immune responses as when those vaccinations are given alone.
http://www.ncbi.nlm.nih.gov.ezp-prod1.hul.harvard.edu/pubmed/11773551?o…
Broadly denouncing all vaccines for all children (particularly if you believe only some children are vulnerable) does real harm to children through measles and other infections, and doesn't help the cause of finding the origins of autism. While people have a right to hold to their conspiracy theories, they do not have a right to put other people in harms way. By ignoring the evidence and imploring parents to not vaccinate their children this group has eaten away at the herd immunity that protects those who cannot be vaccinated for legitimate reasons (e.g. allergy to the vaccine) and those in whom the vaccine failed to provided full protection. The only "success" I can see that this group can truly claim are the measles outbreaks due to the decline in vaccinations (A report came into my email as I wrote this- Measles outbreak in New Zealand started by an unvaccinated family). Harm to others is where the right to free speech ends and those behind such claims should be held accountable. Making these unsupported claims is not benign, even if you believe some relationship exists.
So, I repeat: "What exactly is the goal?"
Mr Handley says:
And people keep asking me why I call anti-vaccination liars "liars".
(At least I know my comment is likely to appear here, unlike Age of Autism where my questioning of Mr Handley's courage and honesty met with a very swift trip to oblivion.)
Thanks Couterfactual,
My vote for the most informed and concise summary of the only true debate.
JB, tick tockâ¦
The goal is quite obvious for GR and the AoA crew - eliminate vaccines. This "debate" has nothing to do with autism, it's simply a means to an end. That's why everytime some bizzare, convoluted side effect of a vaccine comes up, they are all over it. Every time some article hits the news related to vaccination they jump it like a ravenous dog.
Seems to me that Age of Autism might be interested in, you know, focusing on autism. Why do they have posts on Gardasil and several of the other vaccines that while bad under their view do not seem to be correlated to autism?
They are afraid of vaccines. They are afraid of what they are. They are afraid of what they do. They are afraid of the religious implications. They are afraid of pharma companies. They are afraid of the government. They are afraid they will undermine alternative medicine. They are afraid of losing their gravy train.
Curing autism? Not so much. That's just bait to attract concerned parents.
In honor of Paul Harvey,
http://homepage.mac.com/rogereng/Autism/iMovieTheater27.html
So, I repeat: "What exactly is the goal?"
Posted by: the counterfactual
Counterfactual,
This is rather easy to answer.
I think were you are steering yourself into a trap of biased thinking is right about here:
"Broadly denouncing all vaccines for all children"
You are right, completely ending the vaccination program isn't a logical option. What is a logical option is, supplanting the current vaccine program with a safer more effective, and thus more individualized vaccine program.
From my POV this will be beneficial to both sides. For one, an individualized vaccine program would be more effective at conferring immunity (i.e. a higher percentage of those vaccinated will be immune and also to a higher degree.) Moreover, Adverse reactions to vaccines, especially severe adverse reactions, could be eliminated or at the very least, significantly mitigated.
On the other side of the argument, those against vaccines, will feel more confidence if the vaccine program is individualized, thus increasing acceptance rate, and eventually augmenting herd immunity (for the diseases this is applicable.)
The current "one size fits all" program precludes science to similar degree that villifying all vaccines for all children does. I don't see why it is hard to recognize that these two positions lie at opposite ends of the spectrum, and the sensible approach would lie somewhere in the middle.
While we're at it, we should also eliminate diseases and death because they, you know, suck and stuff.
That sounds good, until you consider that you have to show your alternative vaccine program is actually safer. It's not sufficient to propose a vague program that you think might be safer. Don't you think very smart scientists and the CDC would definitely want to make vaccines as safe and effective as possible? It's fine to want to make things as safe as possible, and it's possible to make incremental improvements of anything.
If this is seriously GR's goal, they should be spending money on research that actually makes vaccines safer, in a way that is feasible to implement, and is proven to work. As things stand, they are spending all their money on advertisements against vaccines.
Yup,
they suck and stuff.
Well, that's enough time on the Holo-Deck for one day....
This is true. The science and technology for implementing this type of "customizable" vaccine program is in its infancy. I would guess in 10 years the "one size fits all" will be replaced, until then there will be a social dilemma.
"Don't you think very smart scientists and the CDC would definitely want to make vaccines as safe and effective as possible?"
Of course I do. Actually I know they are currently working on this.
I really don't follow GR, and therefore wouldn't be able to comment on what they spend their money on. But yeah, it would make sense for them to allocate funds as you have suggested rather than solely on ads recommending no vaccines.
Well, that's enough time on the Holo-Deck for one day..
Sure there, Spock...
Why don't you try thinking about it critically.
Here is an article which may help you through that process:
"Trends affecting the future of vaccine development and delivery: The role of demographics, regulatory science, the anti-vaccine movement, and vaccinomics."
Vaccine. 2009 Feb 5. [Epub ahead of print]
Poland GA, Jacobson RM, Ovsyannikova IG.
Mayo Vaccine Research Group, Mayo Clinic, Rochester, MN, USA; Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA; Program in Translational Immunovirology and Biodefense, Mayo Clinic, Rochester, MN, USA.
Abstract:
"Important scientific, cultural, temporal, and secular issues impact the development of, and delivery of vaccines. In this paper we discuss the impact of demographics, regulatory science, the anti-vaccine movement, and finally the impact of the new biology and individualized medicine, which we call vaccinomics, on vaccine development and delivery. A description of the issues and how they have, are, or should be impacting vaccinology is provided, and hopefully will result in increased attention and discussion among vaccinologists. These issues have been under-valued, under-discussed, and in some cases, ignored. We hope that discussion of these issues will result in changes in how we develop, and how we communicate those developments, to the public."
The article Eggplant mania for cancer by Orac really suits Respectful Insolence, not that the Eggplant mania for cancer is the Insolence but that the ramblings of Orac are.
If Orac had done proper research the majority of his ramblings would have been proven to be incorrect. The statements by Dr Cham on his research findings are factual, and by Orac's own definition, cannot be insolent.
I suggest that Orac familiarise him/her self with information available on www.curadermbec5global.com
Just to identify and correct Orac's biased misgivings regarding his article let me select some of his/her shortcomings.
Regarding cancer cures with Curaderm BEC5
Patients treated with Curaderm BEC5 have been followed up for over 5 years and even 10 years post treatment. There were no recurrences. By medical definition if a treated health problem does not recur after 5 years treatment it can be considered that the treatment is a cure.
The mode of action of the BEC glycoalkaloids (extracted from the Devil's Apple fruit or eggplant) has now been evaluated and confirmed by independent scientists throughout the world (see Research Publications when visiting www.curadermbec5global.com). It appears from such publications in scientific journals that BEC glycoalkaloids specifically destroy cancer cells without harming normal cells . When this occurs on the skin whilst treating skin cancers, the area where the cancers were prior to treatment with Curaderm BEC5 regenerates with normal skin replacing the now eliminated skin cancer cells. This is not an unbeliavable claim but factual (see wide range of before, during and after treatment with Curaderm BEC5 lesions on www.curadermbec5global.com "clinical case studies".
The statements of Orac regarding what Dr Cham says, are incorrect. These statements were made, not by Dr Cham, but by respected independent peers such as Dr Jonothan Wright, a highly respected medical doctor who resides in Seattle USA.
Regarding Orac's statement "Silly" me. A search of "eggplant" and "skin cancer" revealed two references. "Silly" Orac indeed. If he/she is delving into scientific information Orac must be diligent, unbiased and could have requested information from Dr Cham before making a fool of him/her self.
Regarding Phases I to IV clinical trials
Again I refer to www.curadermbec5global.com Orac's simplistic statement "simple surgical excision is curative (now because it suits Orac this cure term is permitted) as they say, nothing heals like surgical steel". This statement is in direct contrast to independent published work where it has been reported that 30-67% of BCC (basal cell carcinoma) cases treated by surgery recur.
Again see www.curadermbec5global.com Research Publications ->->->->-> Publications/Medical Research ->->->->-> Sussman, L.A.E and Liggins, D.F. (1996). Incompletely excised basal cell carcinoma: a management dilemma? Aust.NZ.J. Surg. 66,276-278. http://www.ncbi.nlm.nih.gov/pubmed/8634041?dopt=Citation
Orac should also be aware that the other group he/she refers to that actually did a clinical trial using a related compound with reportedly significant efficacy had indeed used Curaderm BEC5 manufactured and supplied to that group by Dr Cham for their clinical trials.
It is also interesting to note that Orac is a depressive person since he/she is so easily depressed by eagerly and in a biased fashion reporting information that is incorrect. All Orac had to do was to request information directly from Dr Cham before doing him/her self, science and the public much injustice.
What in the world does eggplant have to do with the anti-vaccine blathering of Kirby and Kennedy?
Robert Kennedy Jr is a annoying eco-freak urging us to send $500 to save the polarbears when these animals are not endangred in anyway LETS FEED THIS RICH SPOILED BRAT TO THE POLARBEARS,KILLER WHALES AND MAN EATING SKUAS
Dear Sir,
I have never read your blog before but I have read the entire ruling of the special master that you referred to above. On at lesat two occasions he refers to the 'quibbling' of the respondent and also implies that a semantic silliness is going on. Your article above is certainly in keeping with this spirit and is very immature. The special master's ruling is very clear.
Wishing you well anyway,
Paul Sandelson
Concern troll is concerned.