David Kirby's "logic": The hepatitis B vaccine may increase the risk of multiple sclerosis, so it's obvious that vaccines cause autism

It's really hard to take David Kirby seriously any more.

Well, actually, it's been hard to take him seriously for at nearly four years now, ever since he wrote his paean to antivaccinationists, Evidence of Harm, in which no conspiracy-mongering related to mercury as an alleged cause of autism was too out there, too ridiculous, for Kirby to parrot. Since then, he's become antivaccine apologist number one, the go-to guy for the antivaccine movement whenever the twisting of science, logic, and reason was needed to spin an event or a study that refutes the "vaccines cause autism" hypothesis. He's also cheerleader number one for the antivaccine movement whenever he sees a news event or a result that he can twist as somehow supporting the concept that vaccines cause autism (and all sorts of other horrific things). No one can gloat as gleefully and full of smarm as he can over any bit of news he can twist to argue, no matter how tangentially, that vaccines are the tool of the devll, while all the while disingenuously opining that he is, really, truly not "antivaccine." In this, he's like our favorite pediatrician Dr. Jay Gordon on steroids. At least Dr. Gordon seems to have a sense of shame at times. Not our David Kirby. He's loud and he's proud, and he wants so very, very much for you to believe that he knows what he's talking about.

If there's one thing Kirby can do, it's to twist any little bit of information and make it seem as though it supports his diehard belief that vaccines cause autism, even when they do not. The most blatant example of this talent on display came when, ghoul-like, Kirby jumped all over the Hannah Poling case and flogs the Autism Omnibus every chance he gets, knowing that verdicts for some of the test cases are due soon. As I've said before, science may not matter in these cases because (1) the courts are not a good place to decide science and (2) the National Vaccine Injury Compensation Program is set up by design to give plaintiffs every benefit of the doubt. Consequently, what is decided legally and what is scientifically supportable are two entirely different things, often related only by coincidence. Scientific medicine is decided by experimentation, clinical trials, and data, not adjudicated by the courts, no matter how much David Kirby and his posse of worshiping cranks wish it were otherwise.

None of this stops our master of obfuscation, Kirby the Klueless, who is practically orgasmic at a recent ruling of the special masters of the vaccine court on a different omnibus proceeding. This one happens to be about the question of whether the Hepatitis vaccine causes demyelinating diseases, such as multiple sclerosis (MS). Naturally, he is proclaiming his joy to the world on that home of antivaccination looniness, Age of Autism and stringing together the "what ifs" like no other apologist of pseudoscience can:

All eyes are on Vaccine Court this week, as people await rulings in the autism "test cases" on MMR and thimerosal. But another omnibus proceeding involving Hepatitis B vaccine and autoimmune disorders in adults, including MS, has already been quietly ruling in favor of several petitioners. (HERE)

The most recent case was announced about a week ago. In it, the Court ruled that the victim, an adult female, had contracted a form of demyelinating disease and MS, and eventually died, after receiving the Hepatitis B vaccine series. It was just the most recent case in a rash of rulings in the omnibus proceeding dealing with hepatitis B vaccine and "demyelinating diseases such as transverse myelitis (TM), Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating disease (CIDP), and multiple sclerosis (MS)," according to court papers.

"Petitioner has prevailed on the issue of entitlement. The medical records during decedent's final hospitalization reflect that she died from demyelinating disease. Not only did decedent have a vaccine injury, but also her death was vaccine-related," wrote the Special Master in the case.

Kirby, of course, is ecstatic. He thinks he sees in this an omen for the future, as far as the Autism Omnibus goes. Somehow, he thinks this ruling makes a favorable ruling for plaintiffs in the Autism Omnibus more likely. Is he right? Who knows? What I do know is that the ruling Kirby and his antivaccinationist fan club are so full of glee over is based on the thinnest of scientific rationale, as can be seen from the ruling itself. Even the selected bits that Kirby quotes make that obvious. One part that Kirby somehow managed to forget to cite is these passages from the verdict:

To satisfy her burden of proving causation in fact, petitioner must offer "(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury."

And:

In Capizzano v. Secretary of HHS, 440 F.3d 1274, 1325 (Fed. Cir. 2006), the Federal Circuit said "we conclude that requiring either epidemiologic studies, rechallenge, the presence of pathological markers or genetic disposition, or general acceptance in the scientific or medical 6 communities to establish a logical sequence of cause and effect is contrary to what we said in Althen. . . ."

In other words, using standard scientific methods used to derive and verify likely causation from correlation appears to be actively discouraged in the Vaccine Court. Unless I'm reading this wrong, the plaintiffs don't have to present any compelling science, epidemiology, or clinical studies demonstrating causation in order to have a chance of prevailing. In fact, if we are to believe the passage above, such evidence almost seems contrary to the spirit of the law. All plaintiffs have to do is to come up with a "medical theory" (hypothesis really, I really hate the misuse of the word "theory" in the context of science like this, although I'm sure the special masters are using it in a legal, not scientific, context); a temporal relationship; and a "logical," not scientific, sequence of "cause and effect," which to me sounds as though the special masters and the vaccine court don't worry too much about confusing correlation with causation and drawing biological inferences in the absence of strong data.

Of course, Kirby does cite one study, a French study published last fall in Neurology. This study, consistent with the general preponderance of evidence that hepatitis B vaccination in general is not associated with an increased risk of MS, as quoted by Kirby, it did find a suggestion that a specific brand of hepatitis B (HB) vaccine might be associated with an increased risk of MS within three years of vaccination. What Kirby did not quote was the review of the literature in the introduction and discussion that pointed out that no increased risk of MS associated with HB vaccine has in general been observed and that the very authors who did the study cited by Kirby found no increased risk themselves in a previous study.

There's also a problem I have with this study. The relative risk of of MS in this study was determined by subgroup analysis. I'm always concerned when I see subgroup analysis used, because such analyses are fraught with problems. If great care is not taken, they can easily end up turning into data mining exercises that continue until an apparent "positive" correlation is found, and such apparent "positive" correlations become easier and easier to find the more ways the data is cut--unless corrections for multiple comparisons are made and great statistical rigor is applied. Also, in a study of this type, selection bias is a very real possibility. In this study, it might take the form of patients with MS told that a possible link between HB vaccine and MS being more likely to agree to the study in the first place. This is one reason why case control studies are so difficult to do well; it's very difficult to select truly matched controls to compare one's test group to. To their credit, the authors of this study did try to control for selection bias by restricting their analysis of patients with MS to only patients who had been otherwise compliant with the vaccination schedule. Whether their strategy was enough, it's difficult to say. The authors themselves point out that replication is necessary.

Leaving this study aside, it is very important to remember that there is a big difference between the evidentiary standards used in a typical civil tort case and those used for the Autism Omnibus. Civil court cases must adhere to an evidentiary standard known as the Daubert standard. One of the indices of reliability of scientific information in Daubert is the publication of that information in a peer-reviewed scientific journal. Thus, if a plaintiff's lawyer wants to submit a published article or report as scientific evidence in, for example, a personal injury trial, it's very important that the article or report be from a peer-reviewed journal. Unfortunately, the more formal Daubert evidentiary requirements, such as peer review of an article or report, do not apply in the Vaccine Court. As pointed out in the very ruling cited by Kirby, all that's required is anything that the plaintiffs can sell as plausible to the special masters. Consequently, the usual standard of "50% and a feather" that applies to all personal injury cases is even easier to meet in Vaccine Court because the plaintiffs are not restricted to peer-reviewed science. This is in essence a policy decision. Because faith in the vaccine program is considered so important and because vaccination is, in essence, requiring otherwise healthy individuals to take a very small risk, the NVICP and Vaccine Court were designed to be streamlined and to give plaintiffs the benefit of the doubt at every possible angle. That's why I've said from the very beginning that it would not surprise me if one or more of the test cases in the Autism Omnibus were decided in favor of the plaintiffs and why I've said before that such a decision would not be any evidence whatsoever (scientifically, at least) that vaccines cause autism.

But never let it be said that Kirby sees the inherent difference between the law deciding a scientific issue and scientists deciding a scientific issue. He goes on to construct one of his elaborate "chain of 'what-ifs'" that he's become so well known for:

No wonder that Kirby zeroed in like a laser beam on this passage:

It is biologically plausible for hepatitis B to cause demyelination because vaccines are composed of organic compounds of viral or bacterial origin, whether recombinant or otherwise, whose purpose is to initiate an immune response in the recipient,: the Court noted in the ruling. "But if any of the vaccine antigens shares a homology with the recipient's antigens, the host's immune response will attack both the vaccine antigens and the host's antigens, resulting in an autoimmune response. This concept is also known as molecular mimicry and is well-established in immunology."

Molecular mimicry is well established in immunology, but unfortunately there is no evidence in the decision that leads me to think that the court accepted anything more than somewhat plausible-sounding speculation on this case, rather than science. But this ruling did open the door wide open for Kirby to speculate, bring together disparate concepts that sound "science-y" and similar or to implicate a mechanism in from one disease that may or may not have anything to do with another condition, as he does for autoimmune demyelination in MS, trying to relate it to vague and controversial evidence for neuroinflammation in autism as though the two were one in the same and as though it were slam dunk evidence that there was a connection. Of course, Kirby's smart enough to couch his speculation with enough caveats to make him seem not to have gone completely off the reservation while writing confidently enough so that those without a background in biology or medicine find his arguments seemingly plausible, which he does with a vengeance later:

Equally intriguing, along these lines, is a new study published in the Journal of Child Neurology. That paper reported that "anti-myelin-associated glycoprotein positivity" was found in a stunning 62.5% of the autistic children studied. And, a family history of autoimmunity was five times more common in ASD children (50%) than controls (9.4%).

"Anti-myelin-associated glycoprotein serum levels were significantly higher in autistic children than those without such history," the authors wrote. "Autism could be, in part, one of the pediatric autoimmune neuropsychiatric disorders. Further studies are warranted to shed light on the etiopathogenic role of anti-myelin-associated glycoprotein antibodies and the role of immunotherapy in autism."

This information is tantalizing, to say the least. And it could provide new avenues of research into the role of vaccines, demyelinating diseases, "autoimmune neuropsychiatric disorders," and autism.

If the HepB series can destroy myelin in some kids and adults, and cause full-blown MS in adults, then is it really that "fringe" to investigate the plausibility of a biological mechanism whereby some vaccines (including MMR) in a subset of susceptible infants might produce symptoms that are characteristic of autism and/or other neuro-developmental disorders?

The problem here is that the myelin-associated basic proteins (MBPs) found in some autistic children aren't specific, like the ones found in MS patients, and that MBPs are found in a significant number of normal children. Moreover, there is no evidence that autistic children suffer symptoms or neurologic damage akin to what is found in MS patients. In other words, there is no good scientific reason to suspect that the pathophysiology of MS is related to that of autism, even if there is some sort of "autoimmune" component to autism. Indeed, a recent study found in essence no difference in MBP autoantibody titers between autistic children and controls and concluded that it was "unlikely" that MBP played a role in the pathophysiology of autism. Kirby is basing his speculation not only on the thinnest of gruel as far as whether the HB vaccine induces an autoimmune demyelination that can cause MS, but on even thinner gruel when it comes to relating the pathophysiology of MS to that of autism.

In other words, it's just David Kirby being David Kirby, as mendacious and full of bullshit as ever.

I take this post by Kirby as evidence that the AoA crowd is worried. They know that the first rulings on test cases for the Autism Omnibus are due soon, and they're worried that the results, even in that notoriously lax court (as far as scientific standards go) will nonetheless rule against them. Perhaps that's why Kirby says:

For years, the US Government and the IOM have insisted that Hepatitis B vaccine does not and can not cause MS. But the Federal Vaccine Court has now, essentially, overturned that opinion. Will the Court now do the same for vaccines and autism? I don't think so - not this week. But it just might keep that door slightly ajar for the future.

It's idiotic in the extreme to treat the ruling of a court, especially the Vaccine Court, as having any validity whatsoever in answering a scientific question. That's not what any court is designed to do, although they are often called upon to adjudicate matters of science. Moreover, the Vaccine Court was created for political reasons, in order to provide a streamlined mechanism to compensate people with legitimate vaccine injuries, and it appears to be willing to compensate some claimants even if the science supporting their claims of injury is very, very weak or even nonexistent, as long as a "plausible scientific hypothesis" (I refuse to use the word "theory") can be constructed.

Yet that's what David Kirby and his antivaccinationist posse are hanging their hats on. That's because they are not interested in science; they've never been truly interested in following where the science leads. Instead, they just know vaccines cause autism, and that's the only reason that they are interested in a positive verdict in the Autism Omnibus that they can spin as "validation" of their belief. We, the science-based, are also interested in the Omnibus verdict, but not because we believe that a verdict for the plaintiffs would represent any sort of validation of antivaccinationist conspiracy mongering, but rather because we know what a huge P.R. boost a verdict for any of the test case plaintiffs would represent to the antivaccine movement. It would be a boon to them that they would milk for all it's worth. David Kirby knows this too, but more importantly he also knows what a huge P.R. blow to his movement a negative verdict would be. That's why he tries preemptively spin any negative verdict by saying that the court might keep the door to the "vaccine/autism" hypothesis open for a while. In other words, if there is anything in the soon-to-be released verdicts that gives even a hint of succor to the antivaccine movement, he will spin it as "evidence" that the special masters are "leaving the door open" to future claims for "vaccine-induced autism."

As I said before, it's just Kirby being Kirby. It's all he can do. Fortunately for us, some of his commenters are actually honest enough to say what they really believe about vaccines. No going along with the approved mantra of "we're not 'antivaccine,' we're 'pro-safe vaccine'" for them! Besides some commenters speculating that there are people out there defending vaccines who actually enjoy "injuring" children, we have Kathy Blanco laying out her true antivaccination credentials for all to see and providing yet more evidence supporting what I've said all along, that the "Green Our Vaccine" movement is a sham, a means of hiding the true face of the antivaccine movement, in her comment:

Most of the post are pointing to a variety of agents in these vaccines...which bears my nagging question, green a vaccine? Of viruses? Of each and every ingredient-or leave a couple in? Bottom line, there is no possible scientific way to make vaccines safe. Our entire autism family, as in the whole of our autism society, should not be frustrating our causes more, by doing things that are impossible...the most possible thing is, is, to boycott them, IN TOTAL. This is the only way these people will understand our position.

Don't worry, Kathy, your position comes through loud and clear. You are antivaccine to the core, and to you and your fellow travelers it isn't about any ingredients in vaccines. It's about the vaccines themselves. No amount of "greening" vaccines and, no matter how many "objectionable" ingredients are removed, it will never be enough for Kelly or the rest of the antivaccine movement, because it is the ingredients that make vaccines work, namely the bacterial or viral antigens, that scare them.

And David Kirby is their slick and mendacious mouthpiece.

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Even if microbial antigens are involved in autoimmune type MS damage through molecular mimicry (or even triggering oxidative stress in someone with a mitochondrial disorder), Kirby and his antivax accolytes cannot escape the logical and inescapable conclusion that naturally acquired microbial antigens would do exactly the same thing.

It then becomes not so much a question of whether vaccines themselves can trigger damage, but whether the attenuated or reduced antigenic load from vaccines as compared to that resulting from the (largely inevitable) naturally acquired infection could help prevent damage by reducing the incidence of the potentially more harmful infections themselves. Chances are it would, so this would support the use of vaccination for infections that would usually be quite prevalent.

One factoid Kirby doesn't get around to discussing is that for every award of compensation made to a HepB petitioner, there have been many more cases that have been dismissed for failure to prove causation -- that is, where the medical records don't support entitlement, and/or where the petitioner was unable to find an expert willing to testify on his or her behalf. And if none out of the small stable of immunologists generally called upon by petitioners' attorneys (i.e., Dr. Carlo Tornatore, Dr. Joseph Bellanti and, these days, Dr. Yehuda Shoenfeld) is willing to testify for a petitioner, then the claim is speculative indeed.

Nonetheless, marginal, speculative, unwinnable claims still bring home the bacon for VICP attorneys -- although not as much bacon as some would like. My BFF Clifford Shoemaker, Esq. has gotten a few public spankings regarding his recent fee and cost petitions for HepB cases.

Minor correction: Actually, it's Kathy Blanco.

"Jen" posted this on the Kirby thread at AoA after comparing and conflating the superiority of airline safety with vaccination policy:

"God help our children, because the doctors aren't."

That one statement says so much about the emotional reactionary fear produced by ignorance and cranks like Kirby.

By mayhempix (not verified) on 04 Feb 2009 #permalink

Well, if the hepatitis B vaccine leads to MS, then there must be a TON of medical personnel with MS. I seem to recall that hospitals (and a good many outpatient surgery centers) require Hep B vaccination for all employees, including housekeeping, food service, etc. There should be some pretty impressive clusters of MS patients epidemiologically within hospitals. Right? Right? (why am I hearing crickets?)

Kirby is one real mother******. I'd like to bitchslap some sense into him, but I'd only hurt my hands. This has me really steaming.

Why? I have been diagnosed with MS for 20 years, ever since I was 30. For the first 10 years I volunteered to speak at Newly Diagnosed Seminars in order to help people transition. I only stopped because I was the single with MS speaker and I eventually married. I've seen people scared, without support, abandoned by spouses/family and they have no idea where to turn. I've seen people who I thought had more common sense grasp at bee sting therapy, acupuncture, mercury filling replacement, you name it.

Then this f*ckwit turns up and offers nothing. Some of these confused and scared people will try to grasp his chimera rather than work with the people who truly will help them. And that will compound the tragedy.

I'm sure Kirby reads this blog, so directly to you DK:

I hope you rot in whatever hell you believe in, you goddamned fuckwit.

As you said, Orac, Kirby and friends have no interest in the science. They simply want to win over the general public. They are so convinced of the truthiness of their beliefs, that as soon as they can get enough people to believe it too, it will become reality. Perhaps if they concentrate *really hard* and scrunch up their eyes a bit it will help. Sadly, as per the esteemed philosopher Colbert, not only does reality have a liberal bias, it also has a scientific one. Kirby and Blanco are so committed to their fiction that they cannot even conceive of any potential consequences to their actions (they don't need to because THEY ARE RIGHT!??!!?); I'm sure that if measles became endemic again they could rationalize how it wasn't their fault, it was the government's fault (and the AAP and the AMA and the pharmaceutical companies and...and...and...), and somehow it was better for society, and it's not that bad anyway, after all, what's a few dead/encephalopathic/intubated babies compared to the heartbreak of--*gasp*--Asperger's?
(Just to be clear, I do sympathize with families dealing with Asperger's. I'm not heartless. Only a heartless idiot would say that Asperger's--let alone autism or PDD--is a fate worse than death.)

By Cynical Pediatrician (not verified) on 04 Feb 2009 #permalink

"Just to be clear, I do sympathize with families dealing with Asperger's. I'm not heartless."

It's obvious you're not. Meanwhile, speaking of families dealing with Asperger's, I come from a family that didn't exactly deal with Asperger's but pressured me to pretend I had it ("Don't care what anyone else thinks!!!", "'etiquette' means sucking up to rich people," "Just focus on your studies!!! Don't try to have a social life, it'll just happen when you get good grades and people will respect you for it!!!", pronouncing "social life" with a sneer, etc.).

I wonder if Kirby would ever be up for a debate. In a live forum or even perhaps on a blog. Somehow I think he'd decline the invitation.

It is very difficult to take the pills, vicodin in this case we are gaining control of our body, we must remain very careful and not fall and hang on to drugs, always remember to look at this couple and for our future. I read findrxonline.com certainly are very addictive and so we need to know control.

By Greg House vicodin (not verified) on 04 Feb 2009 #permalink

Have couple more Greg!

Orac - if you said more autistic spectrum disorder kids live in the Northern Hemisphere Kirby would find a way to tie that in to vaccines.
About the study on HiB and MS. I think you're right.
They seem to have gone looking for what they wanted and kept looking until they found it.

Well, if the hepatitis B vaccine leads to MS, then there must be a TON of medical personnel with MS.

Never mind them -- HepB is endemic in large parts of Asia. It therefore follows that MS must also be very, very common there and in Asian groups in Europe and the Americas.

Oh, wait -- the Court doesn't take epidemiological evidence into consideration.

By D. C. Sessions (not verified) on 04 Feb 2009 #permalink

"Never mind them -- HepB is endemic in large parts of Asia. It therefore follows that MS must also be very, very common there and in Asian groups in Europe and the Americas."

You forget DC, that the actual disease is totally different, and not as bad as the vaccine because it is natural. It is better to for kids to get their immunity naturally, the way nature intended. These vaccines are man made, THEREFORE it is the source of the problem.

Also, if everyone just jumped into their SUVs, drove down the highway to the center of town, stopped off at Whole Foods and picked up their groceries in the organic foods section, all these diseases and disorders would cease to exist.

Regardless...the evidence is in! This one case decided for this individual proves that HepB, a vaccine, causes MS and that the other vaccines must cause diseases and disorders, including autism. Proof!

Could you comment on any association between erythema multiforme and the flu vaccine? I have a friend whose 16 month old daughter got an ear infection one week after the vaccine (which was treated with antibiotics), then EM the next week. I (and her pediatrician) tried to convince her it could have been due to the antibiotic (possible known cause of EM?), but she refused to get her daughter vaccinated against the flu this year. I haven't found any mention of a vaccine/EM association in the literature, but there are reports of EM as an averse response to the flu vaccine in VAERS.

It is not the case that Daubert requires peer reviewed scientific evidence. The fact that a paper has been peer reviewed is one of the indicia (but not a requirement) for reliability under Daubert. It is, in fact, not even very good for that purpose, but that's another topic.

Perhaps I overstated it because for some reason I thought that indicia was a stronger term than it is. However, for clarification, these are the indicators of "reliable" scientific evidence:

1. Has the scientific theory or technique been empirically tested? According to K. Popper (1989) in The Growth of Scientific Knowledge, "the criterion on the scientific status of a theory is its falsifiability, refutability, and testability".

2. Has the scientific theory or technique been subjected to peer review and publication? This ensures that flaws in the methodology would have been detected and that the technique is finding its way into use via the literature.

3. What is the known or potential error rate? Every scientific idea has Type I and Type II error rates, and these can be estimated with a fair amount of precision. There are known threats to validity and reliability in any tests (experimental and quasi-experimental) of a theory.

4. What is the expert's qualifications and stature in the scientific community? And does the technique rely upon the special skills and equipment of one expert, or can it be replicated by other experts elsewhere?

5. Can the technique and its results be explained with sufficient clarity and simplicity so that the court and the jury can understand its plain meaning? This is just the Marx standard, which is assumed to be incorporated in Daubert as it was with Frye.

#4 can also be phrased as: Whether the theory and technique is generally accepted by a relevant scientific community.

You are correct that the Daubert standard does not actually mandated peer-reviewed evidence per se; however, in practice many courts view evidence that has not been subjected to peer review as failing the Daubert standard.

As for whether peer-review is good for indicating reliability, well, in general it's usually better than evidence that has not been subjected to peer review. It's not an unreasonable standard. Certainly it's far more reliable than the incredibly lax standard applied by the vaccine court, which is primarily a temporal relationship between the vaccine and the adverse event plus a plausible-sounding (to the special masters, at least).

This whole thing makes me think of the witch scene from Monty Python and the Holy Grail.

AoA: "We've found that vaccines cause autism. May we burn Big Pharma?"
Court: "How do you know that vaccines cause autism?"
AoA: "They turned my son into a shell of his former self!"
Son: (shyly)"Hi, Court."
Court: "A shell?"
AoA: (shiftily) "He got better through a casein-free diet and chelation."
Court: "There are ways of telling if vaccines cause autism!"
AoA: "There are? Tell us, what are they then?"
etc, etc.

Orac, you really need to put a filter on rxonline.

You know, I can understand that some people might believe that certain vaccines cause Autism, despite all of the scientific evidence to the contrary. The rate of autism is troubling, and they want to find what is causing it. Vaccines are an easy culprit, they don't understand the science, but they want to believe it is something that they can control and prevent.

What I don't understand is how some people like Kirby seem to want to blame vaccines for everything. No matter what happens, it must be because of some vaccine. None of them are good in their eyes. They don't say "Hey, this one is suspect, let's look at that closer" - nope, we need to get rid of them all, darn the consequences. Those Big Pharmas never do anything good, every single thing they do hurts people. Let's see what bad things we can blame on them today!

Of course, to get their point across they have to downplay the diseases themselves. Chicken Pox? No big deal. Measles? Like a cold. Polio? Most people only have minor symptoms! Cervical cancer? Umm, let's just pretend Gardasil doesn't prevent that! And of course they pretend sanitary conditions are the reason for outbreaks going down. If all else fails lie because these things are rare and no one will know!

Just recently I actually someone claim that most Pharma companies were founded by former Nazi scientists interested in pushing Eugenics. Yeah, they really believe that. Another nimwit carries around a "contract" she plans on trying to force any doctor recommending a vaccine for her or her family to sign that she thinks would make them liable for alot of money should they develop pretty much any malady she can think of anytime afterwards. Good luck finding a doctor when you need one if you pull that out. I wonder if they apply such responsibility to their Chiropracter "adjusting" their infant, or their Homeopath.

How can seemingly normal people be so paranoid? You have to wonder what exactly they have to gain themselves if they make vaccines go away. Then they wouldn't have something convenient to blame everything on. David Kirby might then have to try being a real journalist.

By tracyb928 (not verified) on 04 Feb 2009 #permalink

The rate of autism is troubling, and they want to find what is causing it.

@Tracy: Saying the rate of autism is troubling, when there's no evidence this is the case, is exactly what spawns anti-vaccine nonsense and all manner of autism quackery.

About 1% of the population is autistic. It's probably been this way always. When adults are screened for autism, the vast majority of newly found autistics were never told they were autistic (maybe they were told they were schizophrenic or retarded or they weren't told anything at all). See, for example, this summary of the relevant literature.

In his gloating, Kirby seems to have forgotten that Congress established the Vaccine Injury Compensation Program because Congress acknowledged that vaccine-related injuries can and do happen. Orac, you've noted one purpose of the VICP. A second purpose is identified in the legislative history of the statute creating the VICP: preventing vaccine shortages.

When the statute was enacted, a few tort plaintiffs had already been successful in lawsuits against vaccine manufacturers. Liability insurance skyrocketed. One manufacturer had temporarily withdrawn from the market because it could no longer afford its premiums and several other indicated that they would soon follow suit. From the House Report on the National Childhood Vaccine Injury Act of 1986 (HR Rep. 99-908):

The loss of any of the existing manufacturers of childhood vaccines at this time could create a genuine public health hazard in this country. Currently, there is only one manufacturer of the polio vaccine, one manufacturer of the measles, mumps, rubella (MMR) vaccine, and two manufacturers of the DPT vaccine. Two States, Michigan and Massachusetts, produce their own DPT vaccine. Despite Congressional support, Federal vaccine stockpiles maintained by the Centers for Disease Control (CDC) have never reached CDC's recommended level of six-months' supply. Thus, the withdrawal of even a single manufacturer would present the very real possibility of vaccine shortages, and, in turn, increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases.

The report also notes that many people who had been injured by vaccines were left uncompensated because they could not meet the tort law standard of proof for causation. Thus, to ensure compensation and to reduce the number of lawsuits filed against vaccine manufacturers, Congress articulated a standard for proving causation in the vaccine court that is less stringent that the tort law standard. Injured parties now had an incentive to file their claims in vaccine court, even though damages were capped at $250,000. Again from the House Report:

[This program] is also intended to compensate persons with recognized vaccine injuries without requiring the difficult individual determinations of causation of injury and without a demonstration that a manufacturer was negligent or that a vaccine was defective.

I've heard arguments that Congress has prevented vaccine manufacturers from liability for negligent or otherwise tortious conduct. This is not true. As the excerpt above indicates, plaintiffs had a very difficult time proving even negligence, let alone recklessness or intentional wrongdoing. Congress sought to reduce the number of lawsuits filed against vaccine manufacturers because litigation is extremely expensive, and a defendant who wins usually cannot recover attorneys fees. Vaccine manufacturers could have won every single case and still have been driven out of business.

One last point on the low standard for succeeding as a claimant in vaccine court: Orac lists several factors for assessing the reliability of scientific evidence introduced to support the a claimant's medical theory. Note that it is the underlying evidence that is subject to Daubert not the medical theory itself, which only needs to be "plausible." That is why some claimants recover on medical theories of causation that are not generally accepted.

By Alligator (not verified) on 04 Feb 2009 #permalink

@ Pineyman:

Correlation without causation -- I have a good friend who has MS, and her very favorite cuss word is one you seem to favor as well, "fuckwit." Mildly amusing coincidence.

"Could you comment on any association between erythema multiforme and the flu vaccine? I have a friend whose 16 month old daughter got an ear infection one week after the vaccine (which was treated with antibiotics), then EM the next week. I (and her pediatrician) tried to convince her it could have been due to the antibiotic (possible known cause of EM?), but she refused to get her daughter vaccinated against the flu this year. I haven't found any mention of a vaccine/EM association in the literature, but there are reports of EM as an averse response to the flu vaccine in VAERS."

There are reports following vaccination including Hep B, smallpox, meningitis and other childhood vaccines. They appear to be so unusual that if they occur, they tend to be written up as case reports in the literature. I could find only one published report of it following flu vaccine.
http://www.ijdvl.com/article.asp?issn=0378-6323;year=2008;volume=74;iss…

This infant also had Dpt and Hep B vaccine.

There may be VAERS reports, but I haven't analysed these. There are other reports of allergic type skin reactions to flu vaccine, and EM can be regarded as just one variant of these.
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/02vol28/dr2823ea.html

I suggest that the antibiotic is a far likelier culprit than the vaccine, particularly as the timing would appear to fit the story better. However, if there was sufficient doubt then I can understand a reluctance to repeat the vaccination in case it does provoke any further reaction.

Pineyman said it so well, that I felt a replay is in order:

Kirby is one real mother******. I'd like to bitchslap some sense into him, but I'd only hurt my hands. This has me really steaming.

Why? I have been diagnosed with MS for 20 years, ever since I was 30. For the first 10 years I volunteered to speak at Newly Diagnosed Seminars in order to help people transition. I only stopped because I was the single with MS speaker and I eventually married. I've seen people scared, without support, abandoned by spouses/family and they have no idea where to turn. I've seen people who I thought had more common sense grasp at bee sting therapy, acupuncture, mercury filling replacement, you name it.

Then this f*ckwit turns up and offers nothing. Some of these confused and scared people will try to grasp his chimera rather than work with the people who truly will help them. And that will compound the tragedy.

I'm sure Kirby reads this blog, so directly to you DK:

I hope you rot in whatever hell you believe in, you goddamned fuckwit.

The problem with Kirby, the AoA Junta, etc. can be summed up in two words: importance and impotence. They have are learning that they have no importance, and are just learning that they have an abundance of impotence.

dt-

Thanks for the response. I have seen the literature references to EM and other vaccinations, just not anything to the flu vaccine. My wife (MD in IM/Peds) thinks it's pretty silly to worry about the risk (if any) of EM compared to the risk of flu in toddlers.

BTW Orac - she loves your site!

@Freespeaker - Thanks.

@Pieter B - I only favor it for this type of idiocy. I have other ones for other occasions. Friends can generally denote the topic by the cuss words I use.

All - I have since taken my meds and I am channelling John Astin.

As for whether peer-review is good for indicating reliability, well, in general it's usually better than evidence that has not been subjected to peer review. It's not an unreasonable standard. Certainly it's far more reliable than the incredibly lax standard applied by the vaccine court, which is primarily a temporal relationship between the vaccine and the adverse event plus a plausible-sounding (to the special masters, at least).

"in general" being "usually" better is correct but vitiates it as a criterion and not very useful as a "standard" (non of which the Daubert indicia are). As I understand it, the only matters of law in Daubert are that the Court is the gatekeeper. The relevance and reliability are dicta, although you are correct they are "followed" by many Courts (I put followed in scare quotes because there is so much vagueness about this that trial courts have gone in every possible direction in interpreting it).

In general, Daubert has favored defendants in civil cases, at least when the defendant is a large company. Few plaintiffs make Daubert challenges. And the failure of criminal courts to come remotely close to a Daubert standard is a scandal. Daubert is not an opinion that only applies to civil cases. It is an opinion about the admissibility of evidence on the Federal Rules (it does not apply to state court cases, although many states also have a Daubert-like standard). If we were to apply rules about what is truly based on science to fiber evidence, fingerprints, blood spatters, etc., in criminal cases, prosecutors would be in deep shit. Forrtunately (for them), criminal defendants don't have the resources that civil defendants (like chemical companies and drug companies) have so we see Dauber challenges in those case but not in criminal ones. Sound like Daubert might introduce a bias into the system? BTW, the Daubert reasoning is based on contradictory philosophy of science, badly mangled in the opinion (confusing testability and falsification, for example). Philosopher Susan Haack has written quite astutely about this.

None of this goes to the vaccine issue, but we need to be careful about praising court decisions when they seem to help but ignoring their (manifest) defects. The naive view of science held by Blackmun and the court majority (NB and prescient dissent by Rehnquist) is regrettably prevalent in the scientific community as well.

I just heard on the news this morning that lack of Vitamin D may be a factor in MS. That may be one reason why MS is a condition more common in the higher latitudes where there is less sunshine.

The reason these folks are "hanging their hat" in Vaccine Court is that they want to fleece the government and taxpayers out of as much money as possible while providing as little science as possible. For every true believer there's a trial laywer, charlatan, and head of some activist organization/front for charlatans and trial lawyers looking to make a buck.

By anonimouse (not verified) on 05 Feb 2009 #permalink

Has anyone thought of this..over the past years as more vaccines were added/mandated by the CDC for children..the autism count increased right along with the additional vaccines. Go back to the 80's till now, follow the increase of vaccines, the pattern proves it. It's obvious it was not better diagnosed as they claim. The mass amount of vaccines into a very small baby/toddler is enough to cause problems as excretion to toxin's can accumulate and not excrete. Vaccines should not be given before 2 years of age. It is not necessary. Other countries give less vaccines to toddlers/children, Thimerosal was removed years ago, and vaccines start at 2 years or older. Obviously those countries know something..........

marilyn:

Other countries give less vaccines to toddlers/children, Thimerosal was removed years ago, and vaccines start at 2 years or older. Obviously those countries know something..........

Which countries are those? It is not Japan, UK, Canada or other first world countries. Also, there are plenty of research that show that their rates of autism have also increased.

Do you have any documentation to support your statements?

I don't understand what you are all so hostile about. I suffered an adverse reaction to the hepatitis b vaccination when I was just 26 years old. I was a happy, energenic, positive person who loooved life. My life was turned upside down just 2 hours after recieving my second Hepatitis b vaccination. After 12 1/2 years of suffering unimaginable hospitalizations, I won my case through the Federal Vaccination Compensation Act. I strongly believe that EVERY case should be handled on a case by case by thorough examination of the medical records.
I understand your hostility on EVERYONE blaming the vaccinations for everything. But you also don't understand the frustration of the victims & families who had a normal, healthy child UNTIL THE VACCINATION. You weren't there, & obviously haven't had a personal experience with a family member. Let's not forget that the Act was established to PROTECT the drug companies.(understandably)
I myself have read some bogus claims, but it's the job of the Special Master & medical experts to rule those out & they do all the time. I too have MS. I had read that autopsys have been done on people that they realized had MS that never had any signs throughout their life. I could have been one of those people if not for the Hepatitis B vaccination, (which was obviously the contributing factor in my case). I too worked at a hospital where a co-worker said: I don't understand why YOU reacted to the shot & we didn't? I of course wondered that myself!
It was proven that I had an adverse reaction to the vaccination mainly because my eosinophil count was elevated 10 fold. The only contributing factor for that was the vaccination. Do any of you realize that there are many other vaccinations that cause people great harm? I personally know people that suffered after a flu vaccination & also a teenager that suffered a great deal after the Gardasil vaccination. You would be better using your time trying to reach out to those that have been affected for life.
I know I am not the only person with MS, but I also know that the hepatitis b vaccination lead me to where I am today. Please don't for a minute think going through the Federal Vaccination Compensation Act is an easy task. It is not! I just want help. I have had over $75,000 out of pocket medical expenses. Lost my career that I loved, & have no family contact. My experience has ruined the life I once loved, & I am in pain everyday. Please don't hate me for sharing my story. I am only in my 30's.

You were compensated. That does not mean that the vaccine will do that to everyone, nor that another type of vaccine would not have caused the same reaction. Sorry about your pain, but I do know of several people with MS (common here in the norther part of USA) that got it without any known cause (like a vaccine, like the neighbor who passed away from MS about fifteen years ago).

Chris,
I haven't recieved dime one yet! The life care planners were just here few months ago & they interviewed all of my Drs. The economist is now working on lost wages. I know that not everyone has the reaction I experienced from the vaccination (thank god). Also that I could have recieved a reaction from perhaps a different vaccination. I think that goes along with the theory of certain persons being predisposed, & let's not forget they say there is an environmental factor(like with the people you know).
How is it your neighbor passed away from MS? (how old?) I don't believe them when they say that people don't die from MS. There are several cases. I saw the interview with JK Rowlings (writer of Harry Potter) whose mother died from MS at the young age of 45. Her mother was Progressive since day 1.
I know another problem I experienced just weeks after vaccination, my numbness progressed w/i a few days from my feet to my chest & I was having difficulty breathing. I also recently have read that people have a life expectancy of about 35 years after diagnoses. That would give me a life expectancy of just 61 years old. The Neurologists NEVER volunteer any future predictions to me. I think they just don't know enough.

leresch, you should really consider starting conversations on threads that are less than nineteen months old.

It's true that vaccinations can sometimes have serious and even deadly side-effects. But the question is whether more pain and injury come from the side-effects from the vaccine, or whether more pain and injury would come from the diseases the vaccine protects against. That is a legitimate question and deserves serious debate.

And that is why we frequently get frustrated with people who come here, not because they want a serious debate, but because they want a slanging match where they can put down "the bad guys" who don't think as they do. People who say "Well, obviously your 'mainstream medicine' is full of crooks because here's this mainstream researcher who got caught faking data and none of his papers got retracted!" (In actuality, all of his papers got retracted; it took me less than fifteen minutes to verify that and it took less than fifteen seconds to debunk the "none of his papers got retracted" claim.) People who say "Obviously autism is caused by vaccinations because I've been unable to find even one single example of an unvaccinated autistic person!" (In actuality, people try to present him such evidence, such as the several hundred unvaccinated autistic people recorded in a phone survey performed by the anti-vaccination group Generation Rescue; he discounts them because they have not opened their entire medical records to prove to him that they didn't get vaccinated.) There's more -- the college student who insists that if the data don't support the idea he "knows" is right, then he won't believe the data. The guy who tries to change the subject to transexuals when he can't actually refute an argument he disagrees with.

The best data we have says that vaccination, while not perfect, causes harm in only rare cases, much rarer than harm from the disease would be if widespread vaccination stopped. We're frustrated with people who mistake correlation for causation, who throw down their challenges and then move the goalposts, who apply double standards towards evidence that points to a conclusion they like and evidence that doesn't, who start throwing baseless 'pharma shill' accusations when things don't go their way.

We're frustrated with people who bash the current system of vaccination but don't have anything better to offer, even when they think they do.

By Antaeus Feldspar (not verified) on 02 Oct 2010 #permalink

I tried to be sympathetic, leresch, but you are not having that. I was I supposed to know you had not received any funds, the only data I had was what you wrote. Oh, goody, you have a life expectancy of 61. I am sure my neighbor's 20 year old son would had liked that better than losing his father who only lived to be half that age (according to his grandmother the theory is that MS is caused by some kind of virus, and anything can set it off).

So get over yourself.

You will now be treated like any other necromancer.

I saw the interview with JK Rowlings (writer of Harry Potter) whose mother died from MS at the young age of 45.

My mother died in an airplane crash when she was 42 years old. Should I be campaigning that all airplanes be grounded forever? Or should I be glad that engineers have designed better aircraft over the past forty years?

As I said, get over yourself.

Has anyone thought of this..over the past years as more vaccines were added/mandated by the CDC for children..the autism count increased right along with the additional vaccines.

No, I don't think anyone has suggested that before ;)

For that matter, no one has suggested that autism rates have increased right along with the information revolution, and a host of other modern-era changes.

Joseph, that comment was made over a year ago. I don't think marilyn is coming back. Another reason that necrmancers are annoying.

Wow are you all pissed off about something! Chris, all I was doing was sharing my story. Why the heck would I want sympathy from you or anyone else for that matter?
You guys must be really pissed off about the Hannah Poling case. She is getting 1.5 mil upfront & over 500k a year for life. Good for her! I have NEVER preached that I am anti-vaccine. Let's get that straight!
If any of you or your children were hurt because of a vaccine, you would try to get their medical care taken care of too, believe me.
For your information they don't know what causes MS. All we had to establish was that I had an adverse reaction to the Hepatitis B vaccine that lasted more than 6 months. You can all kiss my butte. I'm just waiting on my check. See Ya!

Hannah Poling has a mitochondrial disorder that she inherited from her mother. She would have had the same or worse reaction had she had the disease, which is why it is high recommended that children with her genetic disorder avoid diseases.

My son suffered seizures that may or may not be the cause of his life-long disability from an actual disease. Right now the focus on "vaccines cause autism" has diverted valuable funds from important services like programs for disabled adults.

I will say it again: get over yourself. You are not the only person on this planet who has suffered.