Dangerous Decision – A travesty of justice and the woeful ineptitude of the media

I know the blogosphere is already filled with loads of informative and lively discourse on this topic. Still, it’s impossible for me not to make my own commentary on what I fear may mark a dangerous tipping point in the anti-vaccine mania. Forgive me in advance for the lengthiness of this post.

Which brings me to the current “controversy” du jour. The news media is all abuzz with the latest in the never-ending vaccine/autism frenzy. As the media and the anti-vaccine lobby would have us believe, the Federal Government has for the first time “conceded” that vaccines may have contributed to the development of autism in a child. Pretty heady stuff in a time of increasing concern (read: paranoia) over vaccine safety. The ruling, handed down by the Special Masters of the federal Vaccine Injury Compensation Program (VCIP), otherwise known as the “Vaccine Court,” actually said nothing about vaccines as a cause of autism. It was, however, an outrageous abuse of the judicial system, and a tremendously dangerous one at that.

The case involves Hannah Poling, a 9 year old girl whose parent’s claim was rendered autistic by a set of vaccines she received when she was 19 months old. The details we currently have concerning the legal case of little Hannah Poling come by way of the greasy fingers of David Kirby, the notorious pseudoscience journalist and author of the hot (and grossly misinformed) book “Evidence of Harm.” Although the court documents are sealed, someone leaked them to Kirby, who subsequently leaked them strategically about the web and to the willing press. Although the media was quick to parrot Kirby’s and the anti-vaccine mob’s spin by painting the court’s decision as a concession that vaccines may have caused Hannah Poling to develop autism, this is not the case. The VICP Special Masters ruling on this case reads as follows:

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

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

However, based on a close reading of the court documents leaked by Kirby himself, it is clear that there is no basis for the ruling, that it is scientifically and medically unsound, and that it is absolutely absurd.

The Hannah Poling Story

[Note: Although the source of the following information is not made clear in the court documents, it appears to come from an affidavit from Hannah’s parents. As I mention below, whereas expert testimony and other sources of evidence are routinely reviewed and authenticated in legal proceedings, this is not necessarily the case in Vaccine Court]

• July 19, 2000: At approximately 19 months of age, Hannah Poling received five injections (DTaP, Hib, MMR, varicella, and IPV). These were catch-up vaccines, as Hannah’s mother had deferred them at the 12 and 15 month visits due to illness (Hannah suffered from recurrent ear infections).
• July 21, 2000: Hannah developed “fever”, “irritability”, “lethargy”, and “she cried for prolonged periods of time”. Hannah’s mother spoke with her pediatrician about this, who informed her that this was a “normal reaction to her immunizations”. According to the mother’s affidavit, Hannah continued to have these symptoms for the next 10 days, although oddly there is nothing in the record that suggests she again attempted to contact a doctor.
• July 31, 2000: Hannah was brought to a doctor with fever and a rash, at which point she was diagnosed with a post-varicella vaccine reaction (this benign reaction to the live-virus chicken pox vaccine occurs in approximately 5% of children).
• September 26, 2000: Two months later she is taken to a doctor with a fever, diarrhea, and an upper respiratory tract infection. The record does not state how she was treated.
• September 28, 2000: Hannah returns to the doctor with persistence of her symptoms. Again, the record does not state how she was treated.
• November 1, 2000: Hannah has tympanostomy tubes inserted (tubes surgically placed through the eardrums in some children with chronic or recurring ear infections to allow better drainage).
• November 13, 2000: Has normal hearing test.
• November 27, 2000: Hannah is taken to a doctor with return of fever, diarrhea, vomiting, decreased energy, and a rash. The record does not state how she was treated.
• November 17, 2000 and November 28, 2000: Hannah is evaluated due to parental concerns about language development. She is found to have deficits in communication and social development. her mother reports at this time that Hannah had been less responsive to verbal direction in the previous 4 months and that she had lost some language skills.
• December 14, 2000: At a follow-up visit for her illness of November 27, 2000, a doctor notes Hannah has a possible speech delay.
• December 21, 2000: Hannah is noted by an ENT doctor to have middle ear fluid, some balance issues, and that she wasn’t progressing with her speech.
• December 14, 2000: She is seen again by the ENT doctor, who found her left ear tube was blocked.
• January 17, 2001: Hannah’s left ear tube replaced.
• February 8, 2001: Hannah is evaluated by Dr. Andrew Zimmerman, a pediatric neurologist who diagnoses her with “regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development.”
• February 8, 2001: Hannah is evaluated by occupational therapists and found to have deficits in “many areas of sensory processing which decrease[d] her ability to interpret sensory input and influence[d] her motor performance as a result.” 
• May 22, 2001: Dr. Richard Kelley, a geneticist consulted by Dr. Zimmerman, diagnosed Hannah with “an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression” that he described as a “mitochondrial PPD.” I’m assuming the text meant to read “PDD” and not “PPD”. PDD (pervasive developmental disorder) is a term used to describe disorders along the autism spectrum.
• October 4, 2001: Hannah is evaluated by Dr. John Shoffner, a neurologist and geneticist. After lab tests showed an elevated lactate:pyruvate ratio, Hannah is presumptively diagnosed with an oxidative phosphorylation disorder. This was confirmed by muscle biopsy which demonstrated “scattered atrophic myofibers that were mostly type one oxidative phosphorylation dependent myofibers, mild increase in lipid in selected myofibers, and occasional myofiber with reduced cytochrome c oxidase activity.”
• February, 2004: Mitochondrial DNA (“mtDNA”) point mutation analysis on Hannah revealed a single nucleotide change in the 16S ribosomal RNA gene.

The above time line is truly fascinating when you look at it in light of both the vaccine court’s ruling, as well as the media’s reporting on this case. Both the court and the media performed egregiously in their tasks.

The Court’s Failing

The vaccine court’s job is to decide whether there are legal grounds to award compensation to individuals deemed to have been harmed by a vaccine. It was established in the mid 1980’s as a no-fault alternative to the traditional tort system to decide cases in which individuals claimed harm from vaccines. It was created out of a spreading fear over the old whole-cell pertussis vaccine (DTP). This was the 1980’s version of the present day MMR/autism myth, or the thimerosal controversy. Because this early form of the vaccine contained many extraneous proteins, there was a much higher incidence of fever and benign febrile seizures in children who received it. Concern that this could cause brain damage in some children led not only to the eventual production of a “cleaner” version of the vaccine (the present day DTaP – aP for acellular pertussis), but also to the National Vaccine Injury Act and the formation of the National Vaccine Injury Compensation Program (VICP), and the Vaccine Court. Now, as a result of the endless waves of baseless fear over vaccines as a cause of autism, we have seen the creation of the Autism Omnibus Proceeding. This is a special branch of the Federal Vaccine Court, overseen by select judges known as Special Masters, that was set up with the sole purpose of handling the scores of legal claims pertaining to the vaccine/autism issue. The court’s mission is to explore three distinct “theories” of general causation, outlined below. Two test cases have been chosen for each of these three “theories”. All are in various stages of the process. Interestingly, the Poling case was to be one of the test cases, but was inexplicably pulled out and quickly settled instead. Although no explanation has been given for this, I find the fact that Hannah’s father is a neurologist who coauthored and published a case report about his daughter with Dr. Shoffner to be an interesting piece of the puzzle.

The three “theories of general causation” being tested by the Vaccine Court are:

1. The MMR vaccine in combinationwith thimerosal-containing vaccines can cause autism.
2. Thimerosal-containing vaccines alone can cause autism.
3. The MMR vaccine alone can cause autism.

It’s absolutely astounding that an entire branch of the federal court has been set up to hear cases pertaining to three “theories of causation” on the vaccines/autism issue, given that there exists not a single shred of science to support any of these so called “theories.” 

One important aspect of this court is that it makes legal and not medical or scientific rulings. That in and of itself is a major problem, since (at least to the public) it’s decisions are equated with the truth or with scientific fact. Of course, even if there was some legaljustification for it’s ruling in the Poling case (which there does not seem to be by any stretch of the imagination), there certainly was no medical or scientific one. However, even by any legal standard, the court’s decision in favor of the Polings makes no sense. There certainly is no “reasonable doubt” criteria used in Vaccine Court. In fact, to quote from the actual rules of the Vaccine Court, “the Special Masters are not bound by formal rules of evidence” at all. A major premise of the Court is to expedite cases, moving them through quickly so as to reach a settlement and avoid extensive litigation that might lead to potentially industry-busting legal action against vaccine manufacturers. In fact, the VCIP was formed principally to protect the vaccine manufacturers against the potential of a financially ruinous onslaught of litigation that might have come their way in the aftermath of the DTP controversy of the 1980’s. Again quoting the official rules of the Court,

Counsel are encouraged to be creative and to take the initiative in suggesting ways in which the record can be constructed quickly and less expensively…Documents will ordinarily not be subject to formal authentication procedures…even opinion testimony may be presented in affidavit or sworn testimony form.

Indeed no expert witnesses or formal evidence, except for the written affidavits of Hanna Poling’s parents, were used to render a decision in this case. Furthermore, from the information provided in the leaked court documents it is clear that there is absolutely no evidence whatsoever that the vaccines Hannah received had anything to do with her condition. The time line presented is unclear at best, and at worst it is evidence againstthe vaccinations being causative. There are large gaps in the time line between the vaccinations and her eventual regression and diagnosis. In fact it wasn’t until 4 months after the vaccinations that Hannah’s mother brought her for evaluation out of concern about her language development. Perhaps most importantly, Hannah had multiple, discrete febrile illnesses in this intervening period of time. The theory put forth by Hannah’s doctor and father is that her newly diagnosed mitochondrial disorder was triggered or exacerbated by the vaccines. If we accept the fact that Hannah’s neurodevelopmental disorder is a result of a mitochondrial disease (which is not entirely clear), it seems that there are many events that could have provided the metabolic stress required to unmask this underling disease. In fact, temporally speaking, the multiple febrile illnesses that Hannah had in the months following her vaccine visit are much more likely candidates. It is entirely possible, and perhaps likely, that Hannah’s ultimate developmental disorder resulted from an acquired infectious encephalopathy. Any metabolic stress, at the right moment, could potentially unmask a mitochondrial disorder, and lead to neurological sequelae such as that suffered by Hannah Poling. The stress of vaccinations, or the febrile immune response sometimes seen following vaccines could be such a metabolic stress. Certainly the significant febrile illnesses Hannah acquired in the weeks and months after this particular doctor’s visit in which she received her vaccines could have been the stressors that unmasked her mitochondrial disorder. Any event could have been the unmasking event. However, although certainly possible, vaccines appear to be the least likely candidates in this particular case. If the vaccines werea metabolic stressor that led to unmasking a mitochondrial disorder, they were likely no more a stressor than any other febrile illness would have been. The media and the anti-vaccine lobby has ingenuously presented the ruling as a governmental concession that vaccines are a cause of autism. Even if we decide to call Hannah’s condition “autism” (including her in the autism “epidemic” of diagnostic substitution) as opposed to a regressive encephalopathy with autistic-like features, and even if we decide that Hannah Poling’s encephalopathy was caused by an underlying mithochondrial disorder, and even if we decide that the vaccine she received on July 9 of 2000 was an inciting event that unmasked this mithochondrial disorder, that in no way amounts to vaccines being a cause of autism. No way, no how. So when you put it all together, the Vaccine Court’s ruling is not only legally unjustifiable, it is scientifically and medically unfounded and not supported by even the court’s time line.

More Media Ineptitude

And here are some headlines, needing very little commentary:

The media has again outdone itself. Hyping the hype, it has succeeded in convincing even those skeptical of the anti-vaccine propagandists that there just might be something after all to this whole vaccine-autism “theory”. Of course, as I mentioned above, Hannah Poling doesn’t necessarily have autism. She suffered from a progressive encephalopathy, possibly due to an underlying mitochondrial disorder and possibly from an infectious encephalitis, that led to a neurodevelopmental disorder which has features similar to those of the autistic spectrum disorders. But that hasn’t stopped the media and the anti-vaccine crusaders from spinning this story until all the lines of reason are thoroughly blurred. The rare parent that doesn’t currently come to me with concerns about vaccinating their children will likely become even more of a rarity. I truly believe we’re in for some pretty sorry times. There are already outbreaks of measles throughout the country, imported from much larger outbreaks in Israel and Switzerland. Unvaccinated children have been sickened because their parents “philosophically” exempted them from getting their measles vaccines, or because they were too young to be vaccinated. We will likely see more and more illness, and probably death, due to irrational fears spread by an inept and greedy media machine. Mark my words.

 

 

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As The World Turns (Into Irrational Fearmongers)

ABC Drama Takes on Science and Parents

 

Richard Cartwright/ABC

Jonny Lee Miller, left, as Eli Stone, with Laura Benanti as the mother of an autistic child, and William Topputo in “Eli Stone.”

 

Eli Stone, the evil corporate lawyer turned superhero defender of the downtrodden, recently made his debut performance on ABC by battling the dark vaccine menace. With this program, the public is once again bombarded by the sensational but utterly false premise that vaccines are a cause of autism. Here he helps defend a mother and her little boy, hapless victim of the pharmaceutical companies and their vaccine preservative, mercuritol (in real life, thimerosal), which has rendered him autistic. Those of us on the side of science and reason just can’t get a break. As a pediatrician, I struggle daily to reassure, explain, and convince parents that there is no rational basis for believing that vaccines are a cause of autism. That there is, in fact, just as much evidence that your astrological star chart can predict your future. Or that homeopathy is more than an expensive placebo. Reams of data from a very large number of well conducted studies have clearly and overwhelmingly (at least in the halls of science which, after all, are the only halls we should be traversing here, right?) refuted any notion of a purported link . There is not enough room to discuss the origins of that myth here (stay tuned for a future entry on that voluminous subject), but suffice it to say that there really is no controversy among respected scientists and physicians. If you follow an evidence-based approach to medical decision making, there is no conclusion to draw other than that absolutely no such link exists. As for the issue of the vaccine preservative thimerosal being a cause of autism, again the data do not demonstrate any evidence of a link. On a multitude of levels there is ample reason to reject any link between thimerosal and autism:

 

1. All of the legitimate studies to date have failed to demonstrate any link. That’s a pretty good reason right there:
   • Thimerosal-Containing Vaccines and Autistic Spectrum Disorder: A Critical Review of Published Original Data
   • Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
   • Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association
   • Safety of Thimerosal Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases
2. The apparent increase in autism cases has continued even after the removal of thimerosal from vaccines.
   • Thimerosal and the Occurrence of Autism: Negative Ecological Evidence from Danish Population-Based Data
   • Continuing Increases in Autism Reported to California’s Developmental Services System: Mercury in Retrograde
   • Pervasive Developmental Disorders is Montreal, Quebec, Canada: Prevalence and Links with Immunizations
3. Finally, and a usually neglected part of the story, the kind of mercury contained in thimerosal (ethylmercury) is very different from the kind produced by industrial pollution, and that ends up in the fish you eat (methylmercury). While methylmercury becomes concentrated in the body’s tissues (most importantly the brain) and thus remains for prolonged periods, ethylmercury is much more rapidly eliminated, and is therefore much less readily stored by the body. Recent studies have demonstrated just how different the pharmacokinetic properties of these two types of mercury are in the bodies of infants. This is important when we consider the US EPA “reference dose” (RfD) for mercury. This is the upper level daily amount, over a lifetime, of a substance that is considered safe to the most sensitive individuals in a population. The RfD for mercury set by the EPA is 0.1 micrograms per kilogram of body weight per day. Many people who believe the thimerosal-autism link point to the fact that, before thimerosal was removed from vaccines, some infants received a total daily dose of mercury from vaccines that came close to or exceeded the EPA’s RfD for mercury. Keep in mind, however, that the RfD was based on long-term, life-time daily exposures, not one time or even multiple time exposures. Also, as a safety factor the RfD was set 10 times higher than the actual estimated safe level. But most importantly, the RfD for mercury is based on data for methylmercury, not ethylmercury. That is, all the assumptions about the hypothetical dangers of exceeding the RfD for mercury, on potentially a few occasions, are based on an RfD for the wrong kind of mercury. As discussed above, the data on the pharmacokinetics of ethylmercury suggests a very different, and far less concerning picture for thimerosal in vaccines.

Which brings us back to Eli Stone and his heroic quest to slay the evil, two-headed, medical-pharma beast. It’s nothing new to see television making mince meat of science. It is fiction after all. In fact, after the American Academy of Pediatrics wrote ABC to protest the airing of the show, the producers placed a disclaimer of sorts at the end of the show (while people were channel surfing or getting another beer from the fridge), stating that vaccines are important, and directing viewers to the CDC’s website. Needless to say, the damage was done. The danger of this kind of TV is that people actually do often believe what they see and hear on the boob tube. Even if they know that what they’re watching is fictional, the messages absolutely effect behaviors. Particularly when they are so often bombarded by misleading and factually incorrect information. In this case, those behaviors involve potentially very dangerous errors in judgement regarding an extremely important medical decision about childrens’ health. Of course, the real-life court room drama that unfolded last month, involving the Federal Vaccine Court, will do even more damage. While the court’s ruling in favor of the family of an autistic child said nothing about vaccines causing autism, the perception many have come away with is just that – that the government has conceeded that vaccines are a cause of autism. I will discuss this case in more detail in an upcoming post. But the two courtroom dramas, one fictionalized, the other frightfully real, will both serve to further tarnish the image of the greatest advance medical science has ever seen, and take us another step backward toward the prevaccine era, and the re-emergence of more childhood death and disease.

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John McCain and the New Epidemic

John McCain is the most recent vector of a raging new epidemic. The disease spread by this epidemic moves quickly, attacks mostly the educated and media savvy in our midst, and is potentially devastating in its consequences. I am referring to the dangerous and fast-moving epidemic of medical and science misinformation that is sweeping the land, pushed along by the strong winds of the media. John McCain, in response to a question posed to him at a recent town hall meeting, stated that

 

It’s indisputable that (autism) is on the rise amongst children, the question is what’s causing it. And we go back and forth and there’s strong evidence that indicates that it’s got to do with a preservative in vaccines.

He went on to say there’s “divided scientific opinion” on the topic of whether vaccines can cause autism. The media is also a major force in the spread of medical and science misinformation. It is often quick to point out that there is a scientific debate on an issue, and to present the topic with the balance so sought after in responsible journalism. The problem with the issue of vaccines and autism is that there is no scientific debate on this issue. There is no balance to the scientific data. The scales are tipped so far to one side (that there is no science linking vaccines to autism) that any reasonable interpreter of the data would conclude it’s time we give up on this particular witch hunt.

The notion of an autism “epidemic” alluded to by Senator McCain, and so often highlighted on the news, is also predominantly a media creation. In fact, the best epidemiology indicates that there is likely no true change in the prevalence of autism, just in the way we define the cases and count the numbers. Incredibly, I have yet to see a single media story that has attempted to intelligently cover this less shocking, but fact-supported, angle.

But the main problem with John McCain’s statement is that he fails to understand what “strong evidence” means in the context of science. Strong evidence is evidence that is presented for peer review, poured over for sound reasoning, scrupulous and meticulous methodology, and accurate statistical analysis. Good scientific papers will also point out their own limitations and flaws, and make suggestions on how to improve on the science. To be declared truly “strong” however, the data must also be replicated and validated by multiple independent investigators. When the evidence is assessed by this standard (the standard by which all science must be judged), John McCain’s statement is seen as entirely erroneous.

The reason Senator McCain was so quick to jump on the vaccines-are-evil bandwagon, and the reasons for this epidemic of medical and science misinformation, are complex. They involve mistrust in the medical establishment, in the Federal government and its oversight, and in the pharmaceutical industry. They also involve the frustrations inherent in the loss of autonomy over one’s own health, an age old problem made more extreme by the ever-evolving complexity of scientific insights into health and disease. At the heart of Senator McCain’s erroneous statement, however, lies an even more ominous sign that indicates this epidemic has no end in sight. A major factor allowing this type of misinformation to take root so easily is the public’s relative ignorance about the general workings of science. If our educational system did a better job teaching science and explaining it’s centrality to so much of what we take for granted in our lives, these types of misstatements would be far less likely to occur and the misunderstandings about so many scientific issues, from believing vaccines cause autism to believing in the efficacy of homeopathy, would fail to become so widespread.

It is ironic that in this election year a major presidential candidate, with both advancing science and improving our educational system as major underpinnings of his platform, would fall victim to an epidemic at least partly preventable by both.

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