One of the cases heard was the Cedillo case, which was used as the test case for the theory that the MMR vaccine plus exposure to thimerosal can trigger brain damage that looks clinically like autism. In February of 2009 the court rejected the claim that Michelle Cedillo’s autism was caused by vaccines. No only was the theory of causation without scientific backing, evidence was presented to show that Michelle Cedillo demonstrated early symptoms of autism prior to ever receiving the MMR vaccine.

In fact the Cedillo case is representative of a fact that scientific research is increasingly demonstrating – that subtle signs of autism are present prior to parents noticing that there is a problem and long before formal diagnosis. The consensus of evidence is that signs of autism appear between 6-12 months of age, and maybe earlier in some cases. Meanwhile, the first MMR vaccine is given at 12 months. Since causes must precede effects, this fact alone is fatal to the MMR-autism hypothesis.

After being rejected by the Autism Omnibus special court, the Cedillos appealed, and their appeal was recently rejected by a federal appeals court (one notch below the Supreme Court). The Examiner reports:

The federal appeals court found that the special master’s decision was justified under a U.S. Supreme Court decision that requires trial judges to determine whether an expert witness’ theory about causation is testable, has an acceptable error rate, and has been peer reviewed and published.

The appeals panel also held that the special master could instead rely on the testimony of a U.S. government expert witness who argued that the testing done by laboratory engaged by the Cedillos was  “severely flawed, and should not be considered reliable.”

The Cedillos report that they are “considering their options” to take their case further.

In general, when complex scientific cases like this are tried in court, with an exhaustive review of the evidence and rules of evidence and argument that preclude reliance on logical fallacies, the outcome is generally favorable to science. We saw this with the intelligent design – Kitzmiller case, and here again with the Autism Omnibus hearings. There is always the risk that a case will be decided on obscure legal grounds, rather than the merits of the science. But I am glad to see that at least occasionally science rules.

Addendum:

After posting this entry, another related news item came to my attention. In the UK a court has awarded 90 thousand pounds to a family whose child (now 18) was alleged injured by the MMR vaccine. Orac has an excellent discussion of the issue. He makes many salient points, which I have also made in previous posts.

Specifically – no one denies that there are risks to vaccines and they occasionally cause serious side effects, although serious effects are rare. Also, compensation for side effects is appropriate. It also needs to be noted that the legal threshold for concluding a possible link between a vaccine and injury is much lower than the scientific threshold, and this is not unreasonable.

In this particular case the decision seems to have been based largely on the temporal association between the MMR and onset of symptoms (which occurred 10 days later). From a scientific point of view, this absolutely can be a coincidence, but from a legal point of view it was sufficient to award compensation.

It also has to be noted that the child in this case does not have autism. He suffers from seizures and mental retardation, but not autism.

In addition to mediocre science journalism we also face dedicated ideological groups who go out of their way to spin, distort, and mutilate the scientific literature all in one direction. The anti-vaccine community is a shining example of this – they can dismiss any study whose conclusions they do not like, while promoting any horrible worthless study as long as it casts suspicion on vaccines.

Yesterday on Age of Autism (the propaganda blog for Generation Rescue) Mark Blaxill gave us another example of this, presenting a terrible pilot study as if we could draw any conclusions from it. The study is yet another publication apparently squeezed out of the same data set that Laura Hewitson has been milking for several years now - a study involving macaque infants and vaccinations. In this study Hewitson claims a significant difference in brain maturation between vaccinated and unvaccinated macaque infants, by MRI and PET analysis. Blaxill presents the study without noting any of its crippling limitations, and the commenters predictably gush.

The first (and really only) thing you need to know about this study is that it involves 9 vaccinated monkeys and 2 controls. That’s right – just 2 controls. The fact that Hewitson bothers to do statistical analysis on such a small set of subjects is laughable. Let’s keep in mind that most pilot studies turn out to be wrong – they are called pilot studies because they are intended to point the way to further research, not as a basis for any conclusions. Serious researches recognize that pilot studies are shots in the dark – and that counts even for good pilot studies, which this is not.

If the outcome were something hard and dramatic – like survival vs death, then 2 subjects would be a reasonable pilot study. But in this case Hewitson is doing a somewhat tricky measurement of brain volume changes over time and binding of opioid ligands in the amygdala. It is also worth noting that there were originally 4 controls, but one was eliminated due to improper protocol. We never learn what happened to the third monkey, we are just told there is data on two controls. This kind of missing data, especially when the overall numbers are so pathetically low, is very concerning.

She is also making multiple analyses (another red flag by itself), which means she can compare multiple variables looking for any difference. Then she invokes the sharpshooter fallacy and declares any change she does find to be clinically meaningful. So while there is no difference in brain volume or amygdala volume between exposed and unexposed monkeys, she finds differences in the change over time. We don’t know if still other variables were looked at and not reported – this is another weakness of pilot studies and why follow up studies replicating the specific effects reported are necessary before any conclusions can be drawn.

As further evidence of looking for any difference then declaring that the outcome of interest, we can look back to Hewitson’s 2008 reporting of her monkey data, in which she wrote:

“Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine.”

But in the current study she finds increased amygdala growth in exposed monkeys:

Not surprisingly, given the different maturational trajectories in exposed vs. unexposed animals, (unexposed decreasing and exposed increasing) there was a statistically significant interaction between exposure and time on total amygdala volume (Wald χ2=10.93; P=0.001). However, there were no significant main effects on total amygdala volume of either exposure (Wald χ2=0.75; P=0.39) or time (Wald χ2=1.14; P=0.29).

So which is it? Reading the results of the current study, especially in light of previous publications, gives the overall impression of a random scatter of data with incredible cherry picking in order to make the argument that there are any meaningful results at all.

Taken by itself, this is a worthless study. The numbers of subjects is too small to do any meaningful analysis. The results are all over the place, and not even consistent with prior publications by the same authors. The analysis is also far-fetched. Hewitson argues that both thimerosal-containing vaccine and MMR (which does not contain thimerosal) contribute to the alleged brain changes she is reporting. While the word “autism” does not appear in her report, Blaxill is concluding in his reporting that these brain changes are the same as those found in autism (an absurd conclusion given how non-specific these changes are, even if real, which cannot be concluded from this study). The anti-vaccine agenda is now clear – they get to have their cake and eat it too. They can now argue that an interaction between thimerosal and MMR cause or contribute to autism, through completely independent mechanisms, apparently.

To put this study further into context, this research is being conducted by the Thoughtful House Center for Children – Andrew Wakefield’s home after he was essentially kicked out of the UK and subsequently struck off. Wakefield’s name, however, does not appear anywhere on the current study, although he was listed as final author on previous publications from the same research. Apparently his name has become too toxic for the Thoughtful House.

The current study also appears in a obscure journal, Acta Neurobiologiae Experimentalis – which dedicated an entire issue to publishing dubious research on autism. The same issue includes two articles by the father and son Geier team – other vaccine and autism researchers who are off in their own world and whose research cannot be replicated.

Conclusion

This current study, as well as the entire macaque research program by Hewitson, is a good example of terrible research. The subject numbers are far too small for any meaningful statistics, and the outcomes being followed are numerous and tricky with a random scatter of results not even consistent between different publications of the same research.

What we have is far worse than ideological reporting and spinning of the scientific research – apparently we have the ideological conduction of research in the first place. This is similar to the research program of Benveniste on homeopathy.

In general it is a good rule to be suspicious of research that seems to be unique to one researcher or research team and is out of step with the broader research community. Unfortunately, such research contaminates the literature and is easily exploited to confuse the media and the public who often do not distinguish crank research from legitimate science.

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Others reporting on this study:

Respectful Insolence – Orac also points out that Hewitson failed to disclose her COI – that she has a child with autism who is part of the Autism Omnibus suit.

Ibrb – Author, Sullivan, also points out that amygdala size should increase in macaques, so it is especially odd that the non-exposed monkeys’ amygdalas shrank. That makes no sense, and is likely due to the quirkiness of having only two controls. So the authors conclusions are entirely based upon a weird result in their tiny control group – i.e. this is completely bunk science.

This, of course, is an extreme example while conspiracy thinking occurs on a spectrum – we all have a little conspiracy theorist inside of us to some degree. Understanding conspiracy thinking in its subtle and extreme forms seems like an important topic of psychological investigation, and yet there is a paucity of good scientific research. Perhaps this is due to the stigma of conspiracies – academics don’t want to get the stench of conspiracy theories on them.

But there is some interesting research, and recently psychologists Viren Swami and Rebecca Coles reviewed this research in their article The Truth is Out There. This is a keeper – one for the skeptical files, if for nothing else than that they provide a handy list of references on conspiracy research.

They discuss that early papers on conspiracy theories focused on characterizing the theories themselves, rather than the people who hold them. They reference Hofstadter’s 1966 “seminal” paper on conspiracy theories in which he provided the following definition:

(Belief in a) “vast, insidious, preternaturally effective international conspiratorial network designed to perpetrate acts of the most fiendish character.”

That sums it up nicely. But the more interesting work came later when researchers began to explore the psychology of the people who hold conspiracy theories. It seems that in this area ideas followed a typical historical pattern – in that at first conspiracy thinking was seen as a form of psychopathology involving paranoid delusional ideation. More recently conspiracy thinking is seen as fulfilling certain universal psychological needs perhaps triggered by situational factors.

In my view both approaches are correct – there appears to be a spectrum of inherent predisposition to conspiracy thinking. At the same time there is a universal appeal to conspiracy theories and situations in which they are more likely to occur, even among the more rational. For example, the authors write:

To the extent that conspiracy theories fill a need for certainty, it is thought they may gain more widespread acceptance in instances when establishment or mainstream explanations contain erroneous information, discrepancies, or ambiguities (Miller, 2002). A conspiracy theory, in this sense, helps explain those ambiguities and ‘provides a convenient alternative to living with uncertainty’ (Zarefsky, 1984, p.72). Or as Young and colleagues (1990, p.104) have put it, ‘[T]he human desire for explanations of all natural phenomena – a drive that spurs inquiry on many levels – aids the conspiracist in the quest for public acceptance.’

Conspiracy thinking is rooted in a desire for control and understanding, triggered by a lack of control and information, or ambiguous and unsatisfying information about big events. The authors emphasize that the public often has a lack of access to adequate information to explain historical events (a situational factor). This can be coupled with what has been called a “crippled epistemology” – a tendency to utilize circular reasoning, confirmation bias, and poor logic coupled with this lack of information. The result is a popular conspiracy theory that makes sense (even if a perverse sense) of events.

One tidbit I found interesting was the offer of the fundamental attribution error as a partial explanation for conspiracy thinking. This is the notion that people tend to assume or overemphasize internal factors (inherent character) as an explanation for the behavior of others, rather than situational or external factors. If we see someone trip while walking down the sidewalk we think they are clumsy, rather than that there was a crack in the sidewalk. We, of course, exempt ourselves from this assumption are are happy to attribute our missteps to unavoidable external factors.

Conspiracy theorists take this attribution error to the extreme, and will often attribute the behavior of others to internal goals (the conspiracy) rather than benign situational factors.

One factor that was not mentioned in the article was the related notion of agency detection – the human tendency to see agency in objects and events. We tend to see a hidden agent where there is none. With respect to conspiracy theories this results from seeing an invisible hand behind otherwise disconnected events. This also relates to the desire for control, understanding, and privileged knowledge.

If you have any interest in conspiracy theories the entire article is worth a read. And as I said, the list of references alone is worth keeping this one in the files.

Just a quick post for today. I want to point out that Age of Autism, the anti-vaccine propaganda blog of Generation Rescue, has really gone over the top in their witch hunt against anyone who dares try to educate the public about vaccines and correct the constant flow of misinformation that comes from the anti-vaccine ideologues. Their chosen method of attack is alleged conflicts of interest – and it is truly a witch hunt.

The core features of a witch hunt are that the accusation of guilt is treated as being equal to guilt, and that the rules of evidence of so fluid and vague that even “spectral” evidence is accepted – anything that creates even the impression of guilt.

The target of their latest smear is my colleague David Gorski, in a post by the truly clueless Jake Crosby. David saw this one coming, and even tried to head it off by telling Jake, both privately and publicly over at SBM, that his information is incorrect or at least misleading. Jake, apparently, is uneducable.

Jake is running a particular witch hunt known as the “pharma shill gambit.” The game here is to find any tenuous connection between a scientist and a pharmaceutical company and then try to pull the Jedi mind trick on readers and convince them the connection is a genuine conflict of interest. Jake would have his readers believe that because David is employed by Wayne State University, and because Wayne State received research grants from Sanofi-Aventis, and Sanofi-Aventis manufactures vaccines – therefore David indirectly receives money from the vaccine industry, and this is an undisclosed conflict of interest (which he has already disclosed, but explained is not a conflict). Got it?

Keep in mind, David does not get research grant money from Sanofi-Aventis or any pharmaceutical company. He has not received any pharmaceutical money at all in 14 years – somewhat unusual for an academic medical researcher. He has never done vaccine research. He has never been paid to consult for vaccine, lecture about vaccines, or express an opinion about vaccines. He is squeaky clean.

But according to Jake – everyone salaried by every university that has ever received money from any pharmaceutical company that has ever produced a vaccine – is a shill for the vaccine industry.

It would be laughable if these clowns were not actually using this kind of spectral evidence to conspiracy-monger and scare parents away from a safe and effective health care measure.

Three recent studies reinforce our worst fears about human nature and make it clear how much of an uphill battle we face. The first looks at attitudes toward the MMR vaccine and which sources parents trust the most. The researchers found:

Five key themes emerged. Parents felt they didn’t have enough information, especially in relation to the dangers associated with not vaccinating. Government sources were not trusted. By contrast, other parents were trusted: ‘Parents trust advice from other parents,’ one mother said. ‘[You] take it on board. You listen to them.’ Parents also revealed they were biased towards risk-related information. And they misunderstood balance, believing that pro- and anti-MMR arguments should be given equal weight even though the scientific evidence overwhelming favours MMR vaccination.

Part of this seems solvable, but part is inherent. The solvable parts include parents not having enough information regarding the dangers of not vaccinating. Lack of information is always the easiest problem to solve – make the information more readily available, especially to people when and where they are making decisions that will be informed by that information.

The other two elements are due to evolved human nature, and therefore are tough nuts to crack. Parents rely on information from other parents – more generally, people find stories much more compelling than data. It makes sense that our natural instincts would be inclined toward stories from our peers. It also makes sense that we would tend to believe and remember such stories, that they would be emotionally profound. In our evolutionary milieu, there was probably more to lose from being doubtful or forgetful of cautionary tales told to us by our peers, than from heeding them. In our complex modern society with phishing scams, used car salesmen, and urban legends, being gullible is probably more of a detriment than being skeptical, but even still we find ourselves riveted by a ripping yarn, especially one of harm that could have been avoided.

Therefore, it should be no surprise that there are numerous grassroots parent groups forming that are basically built on parents or patients educating each other. Such groups come in all flavors – some are guided by a strong dedication to the science, others mix science with anecdote and myth without discrimination, and still others wonder off into a fantasy land of pseudoscience and conspiracy. They each develop their own subculture, mainly driven by person to person communication.

Further, the study shows that people are more compelled by fear than reassurance. Medical decisions are best informed by a careful assessment of risk vs benefit – but emotionally we are much more compelled by the prospect of risk than the prospect of benefit. (Actually, this relationship is more complex and depends on context. People will accept great risk if the potential benefit is huge, like a cure for a terminal or serious illness. If the benefit is more abstract, like preventing a problem they do not currently have, then they focus on  risk.) Here again, we are much more likely to be compelled by one story of a side effect, than all the statistics about preventing illness. The difference in our emotional response to statistics vs our emotional response to dramatic stories largely explains why some people are afraid to fly, and why others fear vaccination.

The other two components of this research – lack of trust in government and favoring balance (even when the information is not balanced) may be more cultural than hard-wired. Either way, they are further barriers to educating the public about vaccines.

The second study is, in some ways, even more disturbing than the first, because it strikes right at the heart of skeptical activism. Researchers find that when people are confronted with scientific information that directly challenges  a cherished belief, their typical response is to argue for the impotence of science – science is unable to prove or disprove my belief. That much is predictable, and any skeptic can tell you that this is a common response. However, the study takes it one step further – they found that people also, after being confronted, shift their belief toward thinking that science in general is impotent. This probably is a mechanism to reduce cognitive dissonance, but in any case confronting people with disconfirming scientific evidence tends to reduce their confidence in science in general.

We have seen this in action with the anti-evolutionists. They not only reject the science of evolution, in their defense of their religious beliefs they often reject science as a methodology. The Discovery Institute has certainly done this, arguing that the materialistic paradigm of science (i.e. science) is crumbling (i.e. impotent). Once you distrust science it is easy to reject any scientific position you don’t like, so the DiscoTute has happily also chucked out modern neuroscience and climatology as well – it’s all an atheistic, materialistic, liberal conspiracy. It’s the snowball effect of anti-science. This study just confirms that.

The third study is in line with the previous two, but looks at belief in ESP. Essentially they told several groups that ESP was either supported by 10% of the public vs 90% of the public or that it was either supported by or rejected by the scientific community. Every permutation of these two variables was tested. The results – people were more likely to regard ESP favorably if they were told that the majority of the public believed in it – we are compelled by the beliefs of our peers. We want to fit in. This is not surprise.

Disturbing, however, was the fact that people in this study were more likely to accept ESP if they were told scientists rejected it rather than accepted it. They took the opposite opinion of the scientific community. What process is at work here? Are they reflexively rejecting authority? Do they assume that scientists are closed-minded about the paranormal if they reject it, but if they accept it does that trigger some natural skepticism?

Regardless of the explanation, it seems that the natural instinct is the opposite of what it should be.

Conclusion

It’s easy to become depressed by this trifecta of studies, but they really don’t paint a picture different than what we already knew – people believe stories over science and come to their conclusions mostly for evolved emotional, rather than dry rational, reasons. These studies are helpful because they illuminate the details and hopefully will provide some guidance as we continue to search for strategies to promote science and reason.

The slogan also serves double duty, allowing anti-vaccinationists to argue that they are not “anti-vaccine” just “pro-safe vaccine.” This is just more marketing savvy, however – a deliberate deception, as many of the people who make this claim also state that they would never vaccinate. (Orac has pointed this out many times in great insolent detail.)

But there are some parents who have bought into this notion and have reduced and/or delayed the number of vaccines their children receive in the hopes that they can strike a better balance of risk vs benefit than the experts have struck. And there are fringe doctors, like Dr. Jay Gordon, who promotes his own evidence-free alternate vaccine schedule, playing into the “too many, too soon” meme.

We can argue along theoretical grounds that the vaccine schedule is safe, without making much of a psychological impact.  Paul Offit has pointed out that the environment presents a far greater daily challenge to young immune systems than a few vaccines do. Further the modern vaccine schedule contains fewer antigens (immune provoking substances) than at any time in the last 100 years (because of the elimination of the smallpox vaccine and improvements made to the pertussis vaccine).

We can also point out the safety data for the recommended vaccine schedule and the utter lack of any evidence to support the claim that Dr. Gordon’s or any other alternate schedule is safer. But fear and anecdote are easier spread than reassurance through dry data.

It is always nice, therefore, to have evidence directly comparing the standard schedule vs a delayed and reduced schedule – and now we have that data. A study published just yesterday online in Pediatrics compares neurological outcomes at age 7 and 10 in 1047 children based upon their vaccine schedule. They used publicly available data from a prior study – the VaccineSafety Datalink study of thimerosal exposure which tracked 42 neuropsychological outcomes.

The authors conclude:

Receipt of all recommended childhood vaccines on time in the first year of life in 1993–1997 had no negative impact on neuropsychological outcomes at 7 to 10 years of age, compared with delayed receipt or nonreceipt of >=1 dose during infancy. In fact, children who received each dose of each vaccine on time performed better on 2 of the 42 outcomes tested after adjustment for multiple familial and socioeconomic factors. Those with delayed receipt or nonreceipt of >=1 infant dose did not perform better on any measure.

There were actually 12 outcomes out of 42 that were superior for the on-time group than the delayed group, but only 2 of these held up after multivariable analysis. What this means is that if you take each outcome by itself there was statistical significance for 12, but because you are looking at 42 different variables that is 42 chances to reach statistical significance, and so we would expect a few to be positive by randomness alone. You can compensate for this with multivariable analysis, and after adjusting for multiple comparisons 2 outcomes remained significant in favor of the on-time group.

This could represent just noise in the data, or it could reflect the fact that parents who comply with the vaccine schedule may provide a more nurturing or healthy environment for their children in other ways. It could also reflect a decreased disease burden in vaccinated children.

In any case – the data strongly argues against any benefit from delaying or reducing vaccine. Meanwhile, delaying or skipping vaccines does come with an increased risk of contracting potential serious childhood diseases, like pertussis.

The usual caveats apply – this study is observational and not experimental. The vaccine schedule was chosen by the parents and not randomized or blinded. A randomized trial at this point, however, has serious ethical concerns and for that reason will likely never be done. Parents who believe in vaccines would probably not allow their children to potentially be randomized to a reduced or absent vaccine schedule, and parents fearful of vaccines may not want their children randomized to a full vaccine schedule. So don’t hold your breath for such a study.

Regardless, this is still a solid study and while not definitive is further evidence and reassurance for the safety of the vaccine schedule and the lack of any safety advantage (in fact a potential disadvantage) to alternate vaccine schedules.

Critics are likely to point out that the cohort of patients studied in this trial were born between 1993 and 1997 and the vaccine schedule has increased since then. However, in order to get long term follow up (like the 10 year follow up in this study) you have to look at the vaccine schedule from at least 10 years ago. Also, the schedule today actually has fewer antigens and almost no thimerosal. Further if there were any safety advantage to delaying or reducing the vaccine schedule this study should still have been able to detect it.

We’ll see how Dr. Gordon and other advocates of an alternate vaccine schedule respond to this new evidence. A science-based practitioner should alter what they do as new evidence comes in. But Gordon and the anti-vaccinationists have demonstrated adequately that they are not evidence-based, and prefer to rely more on their instincts.

On a side note – the British doctor, Andrew Wakefield, whose discredited MMR study was largely responsible for spreading fears about vaccines and autism, was recently “struck off” the list of medical doctors in the UK. This essentially means he has lost his license to practice. Although now he is already on to his next career here in the US as a martyr for the anti-vaccine movement, and this latest dishonor will only enhance that career.

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Reference: Michael J. Smith and Charles R. Woods. On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes. Pediatrics. published online May 24, 2010; DOI: 10.1542/peds.2009-2489

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Addendum:

A letter has been published on the Pediatrics website concerning this study. The author, Lawrence Rosen, points out that the numbers in the results section do not add up. He writes:

If all of the subjects are added as listed, a total of 1037 (not 1047) is obtained. Furthermore, the percentages are incorrect as listed. The final group (311) is in fact 30% of the incorrect total, not 20% as listed.

He is correct, but I think he is using what is essentially a copy edit error to try to discredit publicly available data. The numbers in the tables do add up to 1047 – so one of the numbers copied to the results section was written wrong. The “20%” error is also just a copy mistake and does not affect the data at all. It should be corrected to “30%.”

Dr. Rosen also points out:

Of greater concern to me, personally, is the Financial Disclosure listings. It is very difficult in this day and age to review the authors’ conclusions without considering their considerable potential biases given where their funding comes from. I believe every known vaccine manufacturer is listed on the payroll.

This is the “Conflict of Interest” gambit now common in the anti-vaccine crowd.  Here is the full COI from the paper:

Drs Smith and Woods are or have been unfunded subinvestigators for cross-coverage purposes on vaccine clinical trials for which their colleagues receive funding from Wyeth, Sanofi Pasteur, GSK, MedImmune, and Novartis; and Dr Woods has received honoraria for speaking engagements from Merck, Sanofi Pasteur, Pfizer, and MedImmune and has received research funding from Wyeth and Sanofi Pasteur.

The first part is hardly a conflict – they worked with other researchers without getting paid. Dr. Smith has no other conflicts. Dr. Woods has received some speaking fees and has received research funding from two companies, Wyeth and Sanofi Pasteur.

In other words – they are academic researchers. This does not mean that they are “on the payroll” of pharmaceutical companies, and the COI disclosure says nothing about this study being funded by any company. This is the kind of study that academics can do without external funding, just as part of their academic activities.

But Dr. Rosen is using connections that are ultimately trivial and not relevant to this study as a way to cast doubt on the findings. This is surely to be the strategy of the anti-vaccine movement as a whole, as they have done in the past.

Of course, we need to be vigilant about real conflicts of interest in medical research. But what Dr. Rosen is doing is a COI witch hunt designed to dismiss inconvenient data.

The overall theme of the piece was that anti-vaccine parents are irresponsible and go against the science. In fact, their view are immune to science, as they dismiss the evidence which contradicts their position, and constantly shift the goalposts when evidence goes against a link between vaccines and autism.

The piece did cut some corners on details, but probably will only be noticed by someone steeped in the anti-vaccine movement.

Of course, the anti-vaccinationists have started their whining. To be fair, we complain when journalists do a terrible job of reporting science, which can be interpreted as taking an editorial position with which we disagree. But then it is our job to demonstrate that they got the science wrong. Handley and Gordon are just complaining that their point of view was not catered to.

Gordon is complaining on (of course) the Huffington Post that his interview was not used. Welcome to the club. Any expert who makes themselves available to journalists will at time experience taking time to provide a great deal of information, or to give a long interview, and then have it end up completely on the edit room floor. Or, at times they will just use a quote or two, but miss your main points.

I am not defending this – I think it mostly reflects the fact that journalists and producers write their story before they investigate, and then search for quotes to plug into their narrative. But at other times, a serious journalist will gather a great deal of information, and then decide what the story is, which means some points of view will be left out.

It is heartening to see that those of us who have been defending vaccines from their ideological and pseudoscientific opponents are getting mainstream media attention.

See the show for yourself – it’s worth the hour.

Another ideological alliance is brewing – that between the anti-vaccine movement and extreme environmentalists. This post is not a commentary on environmentalism, and please do not take it as such – the purposes and claims of the two movements are quite distinct. But they share a common thread: distrust of scientific experts and government regulators who reassure the public that environmental exposures are safe.

Robert F. Kennedy Jr. has been the most prominent environmentalist to take up the anti-vaccine cause, in several articles and speeches. While he appears to be only a part-time anti-vaccinationist, his celebrity and street cred among environmentalists lend a great deal of weight to his paranoid musings about scientific fraud and government cover ups. It seems he wants to recapitulate the moral clarity that his uncles displayed in the 1960s, defending the little guy against abuses by the powerful and privileged. He is ready to see a conspiracy, and he wants to be the crusader for environmental justice – and if kids are the alleged victims, all the better. His article in the Huffington Post – “Attack on Mothers,” says it all.

Now there appears to be another environmentalist, who is also a journalist, getting into the anti-vaccine game – one Steven Higgs who writes for The Bloomington Alternative. He came to our attention recently when he wrote a fawning piece about Generation Rescue’s J.B. Handley. David Gorski and I attempted to reason with him over e-mail, but the result indicated to us that Higgs is not an objective journalist but an anti-vaccine activist – and he came to this position largely through his environmental activism – a budding RFK Jr. (David covers this topic also over at Science-Based Medicine today.)

In a recent article Higgs wrote:

I’ve spent most of the past 28 years journalistically investigating conflicts between environmental victims and experts in the relevant fields. And, I can say without qualification, the victims have been right and the experts wrong in every significant story I’ve covered. I can’t think of a single exception.

Such a definitive statement should raise a red flag – no qualifiers or exceptions? That sounds like confirmation bias. Many of the famous environmental cases usually end ambiguously, in that there is no definitive scientific evidence of harm from the environmental exposure, but the families and activists believe they have been harmed. So I guess if someone always sides with the alleged victims, regardless of the scientific evidence, that could confirm the belief that the victims are always right and the experts always wrong.

Another source of confirmation bias is that when claims of environmental toxicity first come to light, the standard scientific approach is to be cautious but investigate. Good scientists are initially skeptical, and require a threshold of evidence before they accept a claim. So initially scientists may say, “Wait a minute, slow down, this evidence is not compelling, we need better evidence.” If eventually the evidence suggests that there was environmental toxicity, then Higgs and others can claim that the experts were wrong – but this is a gross misreading of the nature of scientific skepticism.

This article from 1980 about the Love Canal is a good example – the scientists are simply calling for better evidence, but that can be interpreted as concluding that there was no problem. Love Canal also demonstrates that these issues are complex. There were toxins being dumped into the environment by industry who tried to deny responsibility, local residents were exposed, but the actual health consequences remain a bit controversial, and were likely not as bad as the worst of the media hype suggested. But eventually the science sorted itself out and the government cleaned up the spill and relocated all the residents.

The lesson is – that environmental stories like this one are complex, and anyone who takes a one-sided position “without qualification” is either not looking into it deeply enough or has an axe to grind.

The story of thimerosal in vaccines is far more complex. When I first looked deeply into this issue I actually was not sure which way I would go – I wanted to get the bottom line correct, and did not want to commit myself without fully wrapping my head around this complex story. At points in my research I felt there might really be something going on. It wasn’t until after I fully digested all the science and all the arguments that I was convinced there is no correlation between vaccines and autism or autism spectrum disorder (ASD).

Steven Higgs claims to have done the same thing, as an environmental journalist, but he came away with the opposite conclusion. I am interested in why – how can two people look at the same information and come to opposite conclusions? Of course, I think I am correct (although I am always willing to reconsider my position in light of new information or arguments) and I detect in Higgs the tell-tale signs of bias, as I noted above. Higgs was prepared for an environmental scandal, and he found one.

I have also seen many intelligent and well-meaning people get sucked into a complex pseudoscience – essentially they are overwhelmed by misinformation in an area where they lack expertise, and therefore cannot put that information into context. When one is confronted by a large volume of information all pointing in one direction, it seems compelling. I have even known skeptics who, after watching Loose Change, thought there had to be some hanky panky going on with 9/11. I have debated creationists who are loaded with information – all subtly distorted against evolution. Sophisticated and complex pseudosciences are a nuisance in this way, and the anti-vaccine movement has now developed into just such a pseudoscience.

What is more interesting is how Higgs has responded to scientists with whom he disagrees – and this reflects the danger of “going down the rabbit hole” of a complex pseudoscience, especially those with a conspiracy angle. Higgs wrote:

And with respect to vaccines and autism, I say again, without reservation, parents like J.B. Handley and grandparents like Dan Burton are right about vaccines and autism. The experts are wrong, and their behaviors — their vitriolic attacks upon those who disagree, their underhanded political tactics — suggest they know they were wrong.

We know we are wrong? The undeniable implication (although Higgs denied this to me and David in an e-mail) is that we are lying. We are therefore complicit in a cover up. Also – look at the extreme bias. Higgs thinks that scientists are guilty of “vitriol.” Mostly, scientists will sharply but accurately criticize Handley and his ilk, and some science bloggers will get “insolent” and that can be considered vitriolic. But it is nothing – nothing – compared to the personal smear campaign that Handley and others have launched against those scientists trying to educate the public about vaccines. Remember the infamous “baby-eating” Photoshop job that was published on Handley’s propaganda blog, Age of Autism (and then taken down after it disgusted even the vitriolic echochamber of that blog community). Higgs’ characterization of the situation is so out of touch with reality that it is inexcusable for a journalist.

Also note the populist anti-intellectualism of stating that the experts are always wrong. This reminds me of creationist McLeroy’s famous comment, “Somebody has to stand up to those experts.” In his e-mail to us, Higgs coupled this with the argument ad populi logical fallacy, that he must be right because the anti-vaccine movement has successfully scared much of the public about vaccines.

He also stated that what scientists do is not hard – “That,” as Yoda said, “is why you fail.” Forgive me, but science is hard. That is, doing rigorous science, or even just properly interpreting a complex set of scientific data, is complex, tedious, and exacting. There are numerous pitfalls, and even experienced scientists can get it wrong. We need a community of scientists poring over methods and data, and correcting each other, to grind out a consensus. I’m sorry, but being a passionate journalist (or parent) does not qualify you (as Handley himself has demonstrated on numerous occasions). It is worse to not even have any pause about the fact that the scientific community disagrees with you. That is hubris.

But I am willing to believe that Higgs and others are sincere crusaders, who are just grossly mistaken in their approach and conclusions. Higgs and Handley are not willing to give us the same courtesy – they think we are lying, dishonest, and on the take. They demonstrate that personal attacks is what you do when you don’t have science or even logic on your side.

When it comes to the details of the analysis of the scientific evidence, Higgs buys the anti-vaccine propaganda down the line. Clearly he has consumed Handley’s campaign of misinformation. With regard to a large CDC study showing no correlation between thimerosal and neurodevelopmental disorders, Higgs writes:

The study, titled “Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years,” found that exposure to mercury between birth and 28 days was related to significantly poorer “speech articulation.” It also found a “significant negative association with verbal IQ” among girls.

I have dealt with this this claim here – essentially the study looked at many outcomes, and a couple (when looked at individually) were correlated greater than chance, some positive, and some negative. But when considered as a whole, this is what we expect from chance alone. In other words, the results of this study are exactly what we would predict if there were no correlation between thimerosal and any neurodevelopmental disorder. Put into scientific parlance – this study fails to reject the null hypothesis. Understanding statistics on this level is one of those things experts do that Higgs thinks is so easy.

Higgs also engages in massive cherry picking. He still thinks that thimerosal is responsible for an epidemic of autism – even though the evidence suggests there is no epidemic of autism. But more to the point – the final nail was put into the coffin of the thimerosal hypothesis when almost all of the thimerosal was removed from the vaccine schedule by 2002. The anti-vaccine crowd (most notably David Kirby – another journalist gone astray) predicted that autism rates would plummet. They didn’t – they continued to rise. I and others predicted they would continue to rise, but ultimately would have to level off once diagnostic rates reached saturation. There are some early signs that diagnoses are starting to level off, but it’s too early to say yet. But they did not plummet.

Higgs is now trying to use some recent and minor decrease in a narrow data set in the Ohio Valley to conclude that the much predicted decline in autism rates is finally here (better late than never). He does not mention that the California data, which is the data that the anti-vaccine crowd originally used to argue for a correlation – shows no decline. David takes down this argument further on SBM – for example, the rates are leveling off for all age groups, not just the youngest cohort, which is what you would predict if this were really an effect of removing thimerosal.

This episode also reminds me of David Kirby, who in 2005 was trumping a very short-term downward deflection in the California numbers and happily extrapolating to the predicted “plummet.” But short term trends cannot blithely be extrapolated – as the California data showed. It was just a fluctuation – but the trend continued upward at the same slope.

Conclusion

Steven Higgs appears to be another player in the anti-vaccine scene. His path to this particular pseudoscience appears to be (like RFK Jr.) through environmental activism. But the intellectual failings are the same that skeptics encounter over and over again in denial and pseudoscience. Higgs is cherry picking data, dismissing experts, misunderstanding statistics, and engaging in massive confirmation bias. He then shields himself from the very people who can point out his errors by denigrating them and writing them off as tainted (the Handley method).

Meanwhile he embraces the likes of J. B. Handley and turns a blind eye to his shenanigans.

I like to examine people like Higgs the way doctors study disease – there is pathology there, and by understanding it perhaps we can get better at fighting it. I tried the “seek common ground and understanding” approach over e-mail with Higgs, but he was not interested. Maybe my observations gave him a moment of pause. I doubt it, but I try never to give up on optimism.

Last year we heard the results of the Autism Omnibus – a special court with three special masters set up to resolve about 5,000 cases before the vaccine court claiming that autism resulted from vaccines – either the MMR vaccine or thimerosal (a mercury-based preservative in some vaccines, but removed from most by 2002). In the US there is a Vaccine Injury Compensation Program (VICP) which bypasses the regular courts and awards compensation to those injured by vaccines, paid for by a small tax on each dose of vaccine given. The purpose is to rapidly compensate those who might have been injured (the threshold for evidence is quite low) and to encourage pharmaceutical companies to manufacture vaccines (the threat of suit would make it not viable otherwise).

Over 2008 the Autism Omnibus heard three cases that were presented as the test cases (presumably the best cases they could come up with) for the theory that the  MMR vaccine (with or without thimerosal from other vaccines – MMR never had thimerosal) caused or contributed to autism in some individuals. They ruled against all three cases, stating in very strong terms that there is no evidence to back up the claims of a link between MMR and autism. Judge Hasting wrote of one case – Cedillo:

Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems.

This was a huge blow to the anti-vaccine crowd, and an excellent victory for science and reason. It was the equivalent of the Kitzmiller vs Dover trial for Intelligent Design.

In fact, it reinforced my respect for the judicial process in hearing scientific cases. Stephen J. Gould once observed (I think in reference to Creation Science trials of the 1980s – and I am paraphrasing) that when there are rules of evidence, science generally triumphs over pseudoscience. Pseudosciences, like anti-vaccine nonsense, intelligent design/creationism, and homeopathy – do not fare well when their shenanigans are inspected under the patient and penetrating glare of a thorough trial. Pseudosciences depend upon cherry picking evidence, using logical fallacies, distraction and diversion – all tricks which are exposed by a court following rules of evidence and logic, and taking the time to review all the evidence. We now have a series of high-profile cases in which Gould’s observation is confirmed.

Of course, we always worry that such cases will be decided on matters of law rather than matters of evidence, and then be misinterpreted as confirmation of the pseudoscience. This happened in the 1980s when chiropractors were successful in a restraint of trade suit against the AMA, and then later claimed this was a vindication of chiropractic (it wasn’t). But that’s another story.

In any case, generally science does well in controlled settings, and this past week we saw another example. The Autism Omnibus Court rendered their second set of decisions regarding the next three test cases – this time focusing on the hypothesis that thimerosal causes autism. In all three cases they ruled solidly against the petitioners, stating that they did not make their case. The ruling was not just negative – like the Dover decision, it was a harsh condemnation of the case put forward by the lawyers for the petitioners.

You can read the full decisions here: George and Victoria Mead, Fred and  Mylinda King,  and Timothy and Maria Dwyer. While expressing sympathy for the parents and their children, the masters ruled against every aspect of the case they brought forward. For background, autism is an “off table” injury claim – there is no presumption of causation, but petitioners must demonstrate their case with a “preponderance of evidence.” This is a lower standard than would be used in science, and the decision is limited to whether or not compensation is appropriate – not the ultimate scientific conclusion.

Here are some highlights from the decisions:

Support for petitioners’ claim does not come from the epidemiologic evidence, and petitioners’ claim that the performed studies lack the requisite specificity to detect an association between the receipt of thimerosal-containing vaccines and the allegedly small subset of cases involving autism with clear signs of regression is unavailing.

Petitioners have not shown either that certain children are genetically hypersusceptible to mercury or that certain children are predisposed to have difficulty excreting mercury. The scientific validity of the studies on which petitioners rely has been
questioned and the conclusions drawn from the studies have been criticized as unsupported.

While petitioners have alleged correctly that inorganic mercury can remain in the brain for a period of time, petitioners have not shown that the inorganic mercury deposited in the brain–in the amount that could be received from a full complement of thimerosal containing vaccines–can cause the effects that petitioners have alleged.

If you will excuse a somewhat longer excerpt, this section on the claim that response to treatment with chelation proves mercury caused autism, is a good example of the kind of analysis used in the hearing:

Respondent’s experts Dr. Rust and Dr. Fombonne argued persuasively that it would be inappropriate to draw any inferences concerning causation, in Jordan’s case or any case, from Dr. Mumper’s testimony concerning treatments, for several reasons. First, they pointed out that the treatments to which Dr. Mumper referred have not been demonstrated by scientific testing to have any beneficial effects on autism in general. Dr. Brent provided similar testimony.

Second, respondent’s experts explained that autistic children quite often have periods of substantial improvement in their symptoms in the absence of any treatment, so that it is not reasonable to conclude that a particular period of improvement was caused by any recent treatment.

Third, respondent’s experts noted that because Jordan was often subjected to more than one treatment at a time, it is even more dubious to ascribe any improvements to particular treatments. (Ex. M, paras. 46, 142-43; Tr. 2459-60, 3697-99.)
Moreover, it is clear that chelation treatments do not remove mercury from the brain, so it is not logical to conclude that such treatment could affect autism.

In this regard, on cross-examination Dr. Mumper herself acknowledged that she could not 108 explain how the other treatments upon which she relied could, even in theory, affect the persistent inorganic mercury in the brain that she believes to be a contributing cause of autism.

and…

In concluding that petitioners have failed to establish that Colin’s TCVs caused his ASD, I emphasize that I have not applied a heightened evidentiary burden. I did not require scientific certainty, nor direct evidence of causation. Daubert requires that an opinion be supported by something more than subjective belief; it must be grounded in “the methods and procedures of science.” 509 U.S. at 590. There is no evidence that mercury has ever caused an ASD, only speculation that it might. At best, there is some evidence of an ongoing inflammatory process in ASD, but no indication that it is caused by mercury, and many indications that it is not.

This last paragraph has two points I want to highlight. The first is the citation of the standard of evidence used – as I said, less than scientific proof, but it must be based on something. The second is that Special Master Vowell acknowledges that there is no evidence “mercury has ever caused an ASD (autism spectrum disorder).” This is in contrast to the claim by some anti-vaccinationists that the VICP has admitted vaccines cause autism in some cases. They have not. They have only decided in certain cases that “compensation is appropriate” and in the cases often put forward, such as the Hannah Poling case, the child did not have autism but some other neurological disorder.

Conclusion

This most recent decision by the Autism Omnibus is a slam dunk – after an exhaustive review of the evidence, allowing both sides to present their best case, the three masters are unanimous in their strong opinion that there is no evidence linking thimerosal to autism. They trashed every claim and argument brought forward by the petitioners – the logic and evidence simply does not support their case.

Of course, the anti-vaccinationists cannot accept the unavoidable conclusion – the current evidence simply does not support their claim. So they predictably retreat to conspiracy-mongering. Read the comments to any anti-vaccine blog on this topic – there is the casual assumption that the masters (along with the CDC, AMA, FDA, AAP, and every science-blogger) are in the pockets of evil “big pharma”. They have their narrative, and they will not be distracted by anything so pesky as facts and evidence.

While this is a huge win, there is another case on the horizon that is the cause of some concern – Bruesewitz v. Wyeth. The Supreme Court has agreed to hear this case, which will test whether or not a family can sue a pharmaceutical company for an alleged vaccine injury and bypass the VICP. This case will be decided by the law – not science – and so I have no idea which way it will go. If the Supreme Court rules that people can bypass VICP this will undercut one of its primary functions, and the flood gates will open. Anti-vaccinationists could make it untenable for pharmaceutical companies to market vaccines.

While I applaud this follow up to the Autism Omnibus hearing, I hope it does not follow the pattern of Aliens and Star Trek and peak with the first sequel.

Note: Orac has also written a good review of this topic.

The pandemic spawned a number of controversies. The last H1N1 outbreak, called the “swine flu” (a bit of a misnomer) was in 1976. The vaccine for that strain caused Guillaine Barre Syndrome (GBS) in about 1 in 100,000 people vaccinated. Therefore with the roll out of the new H1N1 vaccine there were cries from the usual assortment of anti-vaccine and other cranks that the vaccine would cause GBS, even though the last 30 years of seasonal flu vaccine has not caused any such outbreaks (at worst the seasonal flu vaccine causes an extra one case of GBS per million doses, but even this is questionable).

There were also accusations that the flu pandemic was a scam created by Big Pharma to sell vaccines, and the real conspiracy nuts claimed that the vaccine was in fact designed to infect and kill people.

Meanwhile, there were questions (legitimate and nutty) about how severe the pandemic actually would be. Of course, no one could know until after it happened.So how bad was it? Here is the updated numbers from the CDC:

# CDC estimates that between 41 million and 84 million cases of 2009 H1N1 occurred between April 2009 and January 16, 2010. The mid-level in this range is about 57 million people infected with 2009 H1N1.

# CDC estimates that between about 183,000 and 378,000 H1N1-related hospitalizations occurred between April 2009 and January 16, 2010. The mid-level in this range is about 257,000 2009 H1N1-related hospitalizations.

# CDC estimates that between about 8,330 and 17,160 2009 H1N1-related deaths occurred between April 2009 and January 16, 2010. The mid-level in this range is about 11,690 2009 H1N1-related deaths

In the last 10 years the seasonal flu has killed on average 36,000 Americans. The numbers above are just for H1N1, and are on top of  seasonal flu numbers (although I have not seen any final numbers on the seasonal flu yet).

So the net effect of H1N1 was to give us an especially bad flu season, but not the worst-case pandemic that was feared. It should be noted that seasonal flu kills mostly those >65 years old, while the H1N1 killed disproportionately those under 65, and also was more fatal to pregnant women. Raw numbers do not reflect this difference.

How about the GBS fears? Cases of GBS were carefully tracked by the CDC and in other countries and there was no increase in GBS associated with the H1N1 vaccine.

While cases are dwindling, the H1N1 pandemic is not quite over. It may be burning itself out, but cases are on the rise still in Africa. This leaves open the possibility that it could come back around. We have already had two waves of H1N1, and a third wave is possible. Further, it is the later waves of such pandemics which may be the most deadly. There has been a new mutation identified in a Mexican patient – and that is the concern, that the virus will mutate to a more virulent or contagious form before it comes back around. It is also possible that this strain of flu will simply combine and synchronize with the seasonal flu.

Thankfully, the H1N1 pandemic was a bit of an anti-climax. While it did bring a particularly bad flu season, it was toward the mild end of the spectrum of predictions. But also, all the fear-mongering about the flu vaccine also fizzled. The vaccine was safe and effective and served to blunt the effects of H1N1.

We will continue to track H1N1 as it may have another act to play.

Addendum:

After I posted the blog the representative from the CDC I had left a message with got back to me, just to confirm my reading of the stats.

The figures posted above are the hospitalizations and deaths from H1N1 alone, but essentially there were negligible cases of seasonal flu this year. This is still a big mystery – we were expecting H1N1 + seasonal flu, but the seasonal flu never showed.

Speculations as to why: high vaccination rates and high rates of compliance with good hygiene and people staying home if they were sick. There is also speculation about the H1N1 “crowding out” the seasonal flu strains, but this is not an established phenomenon.

The bottom line is that the flu is unpredictable – chaos theory in action. It will probably take a year or two to sort out why things happened the way they did.