Children with neurologic and neurodevelopmental conditions are at increased risk for severe outcomes from influenza, including death. Those aren’t my words. They are the first sentence in a new report by the CDC: Severe Influenza Among Children and Young Adults with Neurologic and Neurodevelopmental Conditions — Ohio, 2011.

Individuals with developmental disabilities are at a higher risk of harm or death from infectious diseases. They are also often more difficult to diagnose due to many factors including difficulties with communication.

The residents included a high percentage of individuals with great challenges. For example, of those with severe infections, nine had “do not resuscitate” orders (the reasons for this is not given).

All 13 residents with severe influenza had severe to profound neurologic and neurodevelopmental disabilities, including physical limitations (e.g., scoliosis, hemiplegia or quadriplegia, or cerebral palsy) (Table 1), and nine had “do not resuscitate” orders.

The story from this Ohio facility is bad on many fronts. An outbreak of influenza swept through the facility. 130 residents total. 76 residents had acute onset of respiratory illness. 13 were severely ill. 10 were hospitalized, and seven died.

All of those severely ill had the influenza vaccine. However, during the investigation it was found that the refrigerator that stored the vaccines was 27 degrees F. If the same temperature was in effect while the vaccines were stored, the low temperature could have inactivated the vaccine.

In other words, these individuals were given vaccines but they could have been rendered useless by the storage conditions.

Here is the abstract:

Children with neurologic and neurodevelopmental conditions are at increased risk for severe outcomes from influenza, including death. In April 2011, the Ohio Department of Health and CDC investigated an influenza outbreak that began in February 2011 in a residential facility for 130 children and young adults with neurologic and neurodevelopmental conditions. This report summarizes the characteristics and clinical courses of 13 severely ill residents with suspected or confirmed influenza; 10 were hospitalized, and seven died. Diagnosis is challenging in this population, and clinicians should consider influenza in patients with neurologic and neurodevelopmental conditions who have respiratory illness or a decline in baseline medical status when influenza is circulating in the community. Prompt testing, early and aggressive antiviral treatment, and antiviral chemoprophylaxis are important for these patients. When influenza is suspected, antiviral treatment should be given as soon as possible after symptom onset, ideally within 48 hours. Treatment should not wait for laboratory confirmation of influenza. During outbreaks, antiviral chemoprophylaxis should be provided to all residents of institutional facilities (e.g., nursing homes and long-term- care facilities), regardless of vaccination status. Residential facilities for patients with neurologic and neurodevelopmental conditions are encouraged to vaccinate all eligible residents and staff members against influenza.

The story notes the relatively low efficacy of the influenza vaccine (about 60%). If the vaccines were compromised by low temperature storage, 60% efficacy could have saved 4 of the seven people. So called “vaccine safety” groups should be calling for more effective vaccines, not downplaying the need for vaccines using the 60% figure.

What are the take-away messages from this? For one, influenza is a serious disease. Especially to many in the disability community.

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The recent study on thimerosal and autism was extensive. Much data and many results were included in two technical reports (nearly 400 pages total, volume 1 and volume 2). I haven’t had the time to read them thoroughly yet, but I did catch some interesting pieces of information.

The authors give the ASD prevalence (cases/1000) as a function of HMO and year of birth:

This is pretty flat. No huge increase seen over that 6 year time span. No evidence for an “epidemic”. The prevalence is about 1.1%. This is consistent with the current value quoted by the CDC.

There are remarkably a big variation by parents educational status (63% kids born to mothers who graduated from college). However, since the researchers are working with kids who are enrolled in an HMO, it seems likely this is due to some bias. I.e. the HMO participants could be better educated (and higher income) than the average.

There are indications that increasing parental age is related to increased autism risk. 36% of mothers were in the 30-34 age bracket, 35% were in the 35+ age bracket. So, about 70% of mothers were over 30 years of age. They list father’s age with different brackets, but 79% were 30 years old or older at the time of birth of their child. Again, could be some bias due to HMO membership, but a large fraction of the parents were older.

Some children (both ASD and controls) received no vaccines. Many received vaccines but no thimerosal—i.e. all their vaccines were thimerosal free.

The use of prenatal vitamins is given as having an increased risk of autism, but the odds ratio is not given.

Being a first-born or second-born child has a significant increased risk for autism (hazard ratios of about 1.6). They may discuss this, but I don’t know right now how much of this is due to parents of autistic kids deciding not to have larger families.

One of the stranger results—there is an increased risk of autism when mothers were using prenatal vitamins with folic acid. The hazard ratio was 2.3 with a p value of 0.0176

Pica and childhood lead exposures had very high hazard ratios: 3.7. This is a good case where it is worth asking if this is causal—does pica cause autism or, as is more likely, does autism cause pica and, with it, higher lead exposures.

Poverty was slightly protective for autism (hazard ratio of 0.92). Again, one has to question if this is real or whether poverty just results in a greater likelihood that a child’s autism will be misdiagnosed.

The authors list coexisting conditions for the autistic, ASD and control children:

Epilepsy is much higher at about 5%, compared to 1.6% for controls. Reports of the prevalence of epilepsy amongst autistics are often much higher, though.

Developmental delay (by parent report) is at about 18% for autistics, compared to about 0.66% in controls.

Gi disorder prevalence is about 2% amongst autistics. It is the same (or slightly higher) for controls. This is very interesting given the anecdotal reports of a high prevalence of GI disorders amongst autistics. I suspect this will form some of the complaints about this study—some will say they aren’t looking at the correct population and that a specific study on autism/regression/GI complaints needs to be done.

Cases (those with ASD) were more likely to get thimerosal free HepB and HIB vaccines.

Infants in this study do not get flu vaccines (near zero). Unless that habit has changed dramatically in the past few years—and that most doctors are giving infants flu vaccines with thimerosal—flu vaccines are not likely to be a reason for the continued climb in autism prevalence.

There is a lot more information there. If/when I get the chance to give the reports a more thorough read I’ll post what I find.

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There have been two main theories linking vaccines to an “epidemic” of autism. Both theories have been studied. Both have been heard in the courts. Neither theory had a sound scientific basis and epidemiological data has shown that neither theories explained the increase in autism prevalence in the last 20 years.

First it was proposed that the MMR vaccine resulted in persistent measles infections that lodged in the intestines of children leading to “leaky guts” and that harmful substances were leaked into the blood, traveled to the brain and resulted in autism symptoms. This was proposed by Dr. Andrew Wakefield and has since been shown in epidemiological and other studies to be unsound. (This theory morphed for the Omnibus Autism Proceeding, the vaccine court. The argument there was that the measles virus itself traveled to the brain. Again, it is not supported by epidemiological data and is not scientifically sound).

The second theory was that mercury in vaccines from a compound called thimerosal caused autism. In that theory, it was proposed that autism symptoms were similar to mercury poisoning (autism was a “novel” form of mercury poisoning). This theory was not scientifically sound as autism symptoms are not like mercury poisoning. Previous epidemiological studies have also shown thimerosal was not behind the rising numbers of people diagnosed with autism.

In 2007 there was a study which looked at 1,000 kids aged 7-10 to see if various neurological symptoms were more prevalent in those who received higher exposures to thimerosal. Orac at Respectful Insolence blogged it and Kev posted that piece here on LeftBrainRightBrain as well. That study showed indications that in some measures children may perform more poorly with thimerosal exposure. It also showed that in some measures children may perform better with thimerosal exposure. This mixed result is (a) not very strong in either direction and (b) not very surprising when you look at a lot of different measures at the same time. Chance will result in some measures positive, some negative.

The 2007 study was published in the New England Journal of Medicine as Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years, by Thompson, et al.. (Thompson (2007))

What was missing in that report was a direct study of autism. Given the numbers of children (1,047) selected, there would only be about 10 kids with ASD expected in the group. This is too few for a strong conclusion on autism. At the time of that study it was noted that another study would follow concentrating on autism alone.

That study has just been published in the journal Pediatrics as Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. They studied “256 children with ASD and 752 controls matched by birth year, gender, and [managed care organizations]”. I will give some details here. I expect the treatment on the Science Based Medicine and Steven Novela’s Neurologica blogs to cover the science thoroughly should you wish more detail.

Short answer: thimerosal exposure doesn’t cause an increased risk of autism. Neither thimerosal from vaccines given to the children nor thimerosal from products like Rhogam are behind the increase in autism prevalence we have seen.

It is worth noting that the authors looked at autism with and without regression.

Here is the abstract:

OBJECTIVE: Exposure to thimerosal, a mercury-containing preservative that is used in vaccines and immunoglobulin preparations, has been hypothesized to be associated with increased risk of autism spectrum disorder (ASD). This study was designed to examine relationships between prenatal and infant ethylmercury exposure from thimerosal containing vaccines and/or immunoglobulin preparations and ASD and 2 ASD subcategories: autistic disorder (AD) and ASD with regression.

METHODS: A case-control study was conducted in 3 managed care organizations (MCOs) of 256 children with ASD and 752 controls matched by birth year, gender, and MCO. ASD diagnoses were validated through standardized in-person evaluations. Exposure to thimerosal in vaccines and immunoglobulin preparations was determined from electronic immunization registries, medical charts, and parent interviews. Information on potential confounding factors was obtained from the interviews and medical charts. We used conditional logistic regression to assess associations between ASD, AD, and ASD with regression and exposure to ethylmercury during prenatal, birth-to-1 month, birthto-7-month, and birth-to-20-month periods.

RESULTS: There were no findings of increased risk for any of the 3 ASD outcomes. The adjusted odds ratios (95% confidence intervals) for ASD associated with a 2-SD increase in ethylmercury exposure were 1.12 (0.83–1.51) for prenatal exposure, 0.88 (0.62–1.26) for exposure from birth to 1 month, 0.60 (0.36–0.99) for exposure from birth to 7 months, and 0.60 (0.32– 0.97) for exposure from birth to 20 months.

CONCLUSIONS: In our study of MCO members, prenatal and early-life exposure to ethylmercury from thimerosal-containing vaccines and immunoglobulin preparations was not related to increased risk ASDs. Pediatrics 2010;126:656–664

My guess is that there will be much discussion of the methods on many websites. For now, here are the data from Table 2 and Table 3.

Table 2 (click to enlarge)

Table 3 (click to enlarge)

As with Thompson (2007) the authors will make longer reports available on their website and will allow access to the data.

This study is not the first of its kind. Here are a few of the large studies which have shown a lack of association between thimerosal exposure and autism in the past.

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data

Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Database

Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association

Autism and Thimerosal-Containing Vaccines Lack of Consistent Evidence for an Association

There are more.

One question is whether this will finally quiet those claiming an autism epidemic caused by mercury in vaccines. Unfortunately, I sincerely doubt it. This study included Sallie Bernard of SafeMinds in the acknowledgments. Ms. Bernard was also involved in the Thompson study of 2007. At that time she was listed as a “dissenting” member of the team. She submitted a letter to the NEJM discussing the reasons for her dissention, Perhaps the lack of the word “dissenting” this time is a good sign. I’ll wait and see.

The main question is how much impact this will have on the next generation of families with autistic children. I can’t but wonder that the age of the mercury hypothesis has seen its peak. Not only in research but in general acceptance.

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A new study from Pediatrics has come to the conclusion that:

Timely vaccination during infancy has no adverse effect on neuropsychological outcomes 7 to 10 years later. These data may reassure parents who are concerned that children receive too many vaccines too soon

Lead researcher Michael J. Smith said:

Our study shows that there is only a downside to delaying vaccines, and that is an increased susceptibility to potentially deadly infectious diseases,

...

We hope these findings will encourage more parents to vaccinate according to the American Academy of Pediatrics schedule, and reassure them that they’re making a safe choice when they do so.

Lets hope so. Today is a great day in the forward momentum of the confidence in vaccines now that Andrew Wakefield has been struck off and this latest study can only add yet more weight that no vaccine, no vaccine ingredient and no vaccine schedule has ever been shown to cause autism either directly or indirectly.

This is the first time that a study such as this has been carried out:

...nobody had studied whether getting several vaccinations in a short time could have negative consequences, for instance by overloading the immune system, as many parents believe, according to Smith. He found that receiving as many as 10 different shots—including flu and whooping cough—had no impact.

And a CDC spokesman said:

Parents that are considering delaying vaccination should realize that there aren’t any specific benefits, and that they are putting their child at risk, and not only their child but also the community,

An excellent point. The benefits of vaccination are not just personal but societal. Those who refuse to vaccinate not only risk the personal well being of their children but the society they choose to live in.

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Its always a bit of a dilemma when writing an entry that doesn’t really touch on autism at all. But I have become convinced that the population beyond the autistic and autism community need to know that most of us within these communities do not support the know nothing anti-science, anti-medicine and most of all, anti-vaccine community that has a vocal minority place within our communities and that as such we owe it to our societies to vocally counter these idiots such as those at Age of Autism who spread lies and promote an age of ignorance.

I’ve heard it said by writers and readers of blogs like Age of Autism and sites like JABS that H1N1 is ‘no big deal’ and that the H1N1 vaccine is a dangerous and untested shot. Both of these things are untrue.

My partners youngest daughter (not autistic, although her eldest is) recently received an invitation to participate in the H1N1 vaccine testing which would involve three visits to the local hospital over a four week period. And over the 4 week period they would take two blood draws. This is for an ongoing safety and efficacy testing.

Swine flu is a big deal. In the UK there have been over 150 deaths since June 2009. Thats about 1 death per day.

In the US, the latest FluView weekly roundup notes 18 flu related child deaths of which 15 were due to H1N1. Fifteen in 7 days.

Next time someone says H1N1 is a ‘nothing’ issue, point them to these stats, behind which lie the dead bodies of real people.

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Vaccines and autism: publicity of the topic just got a “shot in the arm” this weekend with a story on Dateline. As part of the story, Dr. Bernadine Healy was interviewed.

Dr. Healy has called for more research into the proposed vaccine-autism link. She has some good credentials (former head of the National Institutes of Health)

Take a look at what she had to say.

I really want people to actually watch her before reading my opinions. I’m very interested in what other people see, untainted by my opinion.

Did you watch? OK, go ahead.

My view: She sounds like a politician on a stump speech. She makes her “constituency” think that she made a commitment when, in fact, she never does.

“...in the area of autism, and in the area of vaccines, there are many many questions that need to be answered and they need a broad base of science.”

Does she ever say, “we need to research vaccines as a cause of autism”? No. She doesn’t. She mentions autism and she mentions vaccines, but doesn’t really put them together.

Another statement, in talking about vaccine safety:

“...it is about understanding if something is happening that we need to address in a small subset”

Her words are very imprecise, letting the reader interpret as he/she will.

“small subset”. Some will hear that and think, “children with autism, that’s the small subset” and the “take away” message will be, “she supports the idea of vaccines causing an epidemic of autism”. It’s possible that “small subset” means a small subset of autistics. In other words, she might be accepting the data that shows vaccines haven’t caused an epidemic of autism. It’s possible that “small subset” is the very small subset of people who are injured by vaccines, some of whom are autistic and some of whom are not. In which case, what she said isn’t controversial at all.

We just can’t tell what she meant from what she said.

And, yet, many would could come away thinking that her statement supports their side.

Perfect politician speak. Very reminiscent of the style Sentator McCain used in his comments courting the autism vote in the last U.S. presidential election.

Dr. Healy has not always been so cautious with her words. When she first appeared on the autism scene, she made accusations against the Institute of Medicine. She also made statements about young children having no risk for Hepatitis B, questioning the need for that vaccine. There are more examples, but these two serve the point: when we make specific statements, we run the risk of being wrong.

The rest of the interview was mostly “mom and apple pie” statements about good communication with parents, pediatricians and the American Academy of Pediatrics.

She also talks about vaccines and how there are “questions that must be addressed”. See what I mean about how that sounds like a politician? What questions must be addressed? The listener is likely to fill in the blank and feel that Dr. Healy made a statement supporting, say, questions about vaccines potentially causing autism.

Contrast Dr. Healy’s non-statements to the statement by the American Academy of Pediatrics on the Dateline website.

August 2009

Statement from the American Academy of Pediatrics to “Dateline”

The immunization schedule is considered the ideal schedule for healthy children. It is designed to stimulate children’s immune systems so they will not suffer illness, disability and death from vaccine-preventable diseases. The recommended immunization schedule is based on the latest scientific research. There is no scientific evidence to support the safety or effectiveness of alternative schedules. Delaying vaccines leaves babies unprotected when they are most vulnerable to vaccine-preventable diseases such as hepatitis B (a liver infection), rotavirus (severe diarrheal disease), whooping cough and bacterial meningitis.

Autism is a devastating, poorly understood neurodevelopmental condition. It is upsetting for families not to know what caused their child’s autism. The American Academy of Pediatrics (AAP) supports additional research to investigate genetic and environmental factors that may affect the developing brain. While it is likely that there are many environmental factors that influence the development of autism, vaccines are not the cause of autism. We know this because many careful and repeated studies show no link between vaccines and autism. Specifically, numerous studies have refuted Andrew Wakefield’s theory that MMR vaccine is linked to bowel disorders and autism. Every aspect of Dr. Wakefield’s theory has been disproven.

The AAP wants parents to have complete, science-based information so they can make the best decision for their child about immunization. The AAP urges parents who have questions about vaccines to talk to their pediatrician. For more information, visit www.aap.org.

See the difference between Dr. Healy’s interview and the AAP statement? The AAP said something concrete. They said that Wakefield’s theory has been disproven. They say that they support additional research into genetic and environmental factors.

Having done so, the AAP will almost certainly have their message picked apart and misinterpreted.

For example, one common attack I would expect to see is “if they don’t know what causes autism, how can they say that vaccines didn’t cause an autism epidemic?” This comes up enough that I have a handy counterexample: I, for one, feel safe in not applying research funding into the “refrigerator mother” theory, even though we don’t know what causes autism. I will go out on a limb and state that it is likely that most autism parents and autistics would agree with me on that. See, one can reject some ideas even without a complete understanding of autism.

What I really expect is for some people to jump on the “environmental factors” statement by the AAP. David Kirby, for one, has made a mini-career out of collecting such statements. Each time it is evidence of a “new” position on the possibility of environmental causes of autism by one group or another, Mr. Kirby jumps on it and adds it to his list.

I guess this hasn’t happened with this statement by the AAP because because this isn’t a new position. For example, this past May they stated, “A complex collection of variables, both genetic and environmental, have been associated with the development of autism spectrum disorders (ASD).”. This statement is a part of the FAQ (frequently asked questions) on the AAP autism website.

I was amazed then that Mr. Kirby didn’t extrapolate wildly on the “environmental” statements by the AAP.He tends to leave it implied that anyone who accepts “environmental causes” of autism is referring to events that happen to young children and not, as is most often the case in the studied environmental risk factors, prenatal events. Mr. Kirby tends to imply that anyone who agrees that there are environmental risk factors likely supports his contention that mercury causes autism.

In other words, he tends to claim support for his ideas even where there is none.

But, enough about Mr. Kirby. At least he sometimes makes definitive statements. Yes, he likes to hide behind the cloak of “what if” statements that are supposed to be “sparking a national debate”. But, he can and does occasionally make hard statements, unlike Dr. Healy in her interview.

The CDC also submitted a statement to Dateline. It too has concrete statements:

August 26, 2009

NBC News
30 Rockefeller Plaza
Suite 325W-1
NY, NY 10112

CDC Statement on Vaccine Safety, Thimerosal and Autism

At the Centers for Disease Control and Prevention we understand that autism and autism spectrum disorders place a heavy burden on many families.

Despite compelling scientific evidence against a link between vaccines and autism, some parents wonder if vaccines could have caused their children to develop autism. The suggestion that MMR (Measles, Mumps and Rubella) vaccine could be related to autism was initially raised in a 1998 article by Andrew Wakefield and colleagues. Several subsequent studies by independent researchers, however, have not found an association. A study that included the same laboratory that was involved in Wakefield’s original studies was not able to replicate the original findings. Concerns have been raised about possible biases in the study by Wakefield, and 10 of the coauthors of the 1998 article have published a formal retraction of the article’s conclusions. A review by the Institute of Medicine in 2004 concluded that the evidence indicates that MMR vaccine does not cause autism.

In early 2000, concerns were raised that thimerosal, a mercury-based preservative that had been used in some childhood vaccines, could cause autism. Numerous studies have found no association between thimerosal exposure and autism. Since thimerosal was removed from all U.S. childhood vaccines by 2002 (with the exception of the flu vaccine), we have not seen a decline in children being identified with autism, indicating that thimerosal is unlikely to be related to autism.

The CDC supports research to better understand the causes of autism and to develop more effective treatments. Early intervention is critical and research is our best hope for understanding the causes of autism. Through collaborations with partners in government, research centers, and the public, CDC is focusing on three areas: 1) understanding the frequency and trends of autism spectrum disorders, 2) advancing research in the search for causes and 3) improving early detection and diagnosis.

CDC places a high priority on vaccine safety and the integrity and credibility of our vaccine safety research. CDC, along with other federal agencies, is committed to assuring the safety of vaccines through rigorous pre-licensure trials and post-licensure monitoring. This commitment not only stems from our scientific and medical dedication, it is also personal—for most of us who work at CDC are also parents and grandparents. We too, are concerned about the health and safety of children.

Frank Destefano, M.D., M.P.H. Edwin Trevathan, M.D., M.P.H.
Director Director

Immunization Safety Office, CDC National Center on Birth Defects
& Developmental Disabilities, CDC

Again, unlike Dr. Healy, the CDC makes definitive statements. On statement I am surprised I haven’t read people pointing out the “burden” statement.

I also am surprised I haven’t heard people jump on some other statements. Specifically, “understanding the frequency and trends of autism spectrum disorders”. That’s a perfect opening for people to claim that the CDC believes there could be a vaccine-caused epidemic of autism.

Most people tend to just equate the idea of the autism rate increasing with vaccines and or mercury. So, if anyone were to say, “so-and-so thinks the autism rate may be increasing”, they usually are trying to imply, “so-and-so thinks that vaccines cause autism”.

Well, guess what, the CDC does think it is possible that the autism rate is increasing. That’s why they are monitoring the autism rate.

But, bringing this back to Dr. Healy. I am on the one hand pleased that she didn’t make her false statements about the IOM or other unfounded comments. On the other hand, I would hope that if MSNBC thought it valuable to interview her, they would have found it valuable to get her to actually say something concrete.

It is interesting to look at the blog post on the Age of Autism blog about this. They show the video, with no commentary other than the title: “Dr. Bernadine Healy Implies Hubris on Part of Docs Who Deny Vaccine Autism Possibility”.

Even they couldn’t pull a concrete conclusion out of this interview. The strongest statement they are left with is “implies hubris”.

If AoA can’t spin this interview into a strong statement, it’s pretty clearly a fairly empty interview.

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For as long as I can recall, this has been one of the clarion calls of the autism/antivaccine/pro-disease groups – that the only way to know if vaccines cause autism is to do a ‘simple’ study of vaccinated vs unvaccinated populations. Indeed, Generation Rescue carried out an ill-fated phone survey that in reality meant absolutely nothing so badly was it put together and carried out. But even if it had been well designed and carried out the results were not good for pro-disease anti-vaccine autism believers:

Number of boys and girls with Aspergers
Unvaccinated: 1% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 2%

Conclusion: you are 1% more likely to have Aspergers if you have been partially vaccinated than unvaccinated. If you are fully vaccinated your chance of being Aspergers is no greater than if you were unvaccinated.

Number of boys and girls with PDDNOS
Unvaccinated: 2% of total
Partially vaccinated: 2% of total
Fully vaccinated: 1%
Fully and Partially combined: 1%

Conclusion: you are 1% more likely to have PDDNOS if you are unvaccinated. If you are fully vaccinated your chance of being PDDNOS is 1% less than if you were unvaccinated.

Number of boys and girls with Autism
Unvaccinated: 2% of total
Partially vaccinated: 4% of total
Fully vaccinated: 2%
Fully and Partially combined: 2%

Conclusion: you are 2% more likely to have autism if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is no greater than if you were unvaccinated.

Number of boys and girls with all ASD’s
Unvaccinated: 4% of total
Partially vaccinated: 6% of total
Fully vaccinated: 3%
Fully and Partially combined: 3%

Conclusion: you are 2% more likely to have an ASD if you have been partially vaccinated. If you are fully vaccinated your chance of being autistic is 1% less than if you were unvaccinated.

Overall conclusion: the best way to avoid being diagnosed with an ASD is to be fully vaccinated according to the CDC schedule.

And in September of last year, you may recall the announcement of yet another study that demonstrated there was no link between MMR and autism. During the press conference that launched that study David Kirby asked the lead author – Ian Lipkin – what his thoughts were about a vaccinated vs unvaccinated study. His answer was:

Very difficult if not impossible.

Given that, the US NVAC vaccine safety group released a draft of their latest thinking on the issue of vaccine safety which touched on the idea of doing this sort of study. The entire section related to this is quoted in full below:

Feasibility study of Vaccinated/Unvaccinated/Alternatively Vaccinated Children

Members of the public, stakeholders, and the Interagency Autism Coordinating Committee (IACC) have articulated interest in a study of vaccinated vs. unvaccinated children to determine if there are differences in health outcomes between groups with varying exposures to vaccines. The Working Group considered drafting a recommendation for an IOM review of the science, epidemiology and feasibility of studies of unvaccinated, vaccine delayed, and vaccinated children. The Writing Group Draft Document on Gaps in Research Agenda further developed this idea. The Working Group wishes to clarify several points on this topic. First, the Working Group believes that the strongest study design, a randomized clinical trial that includes a study arm receiving no vaccine or vaccine not given in accord with the current recommended schedule, is not ethical, would not pass IRB review, and cannot be done. The type of study that is being suggested would be an observational study of populations looking at natural variation in vaccination schedules including some children where vaccination is declined through parental intent. All children in the study should be recommended to receive the standard immunization schedule. The Working Group endorses the Writing Group’s recommendation for an external expert committee, such as the Institute of Medicine, with broad methodological, design, and ethical expertise to consider “strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs to examine outcomes in unvaccinated, vaccine delayed and vaccinated children and report back to the NVAC.”

The Working Group does not necessarily agree with all of the language in the Writing Group’s statement, but with its general intent. The process should be open and transparent, engaging individuals from a broad range of sectors. Considerations as outlined by the Writing Group and modified by the Working Group are as follows:

– This review should consider strengths and weaknesses, ethical issues and feasibility including timelines and cost of various study designs and report back to the NVAC – Consideration should be given to broad biomedical research including laboratory studies, and animal studies. – Consideration should also be given to study designs comparing children vaccinated by the standard immunization schedule with unvaccinated children (by parental intention), and possibly partially vaccinated children or children vaccinated by alternative immunization schedules – Outcomes to assess include biomarkers of immunity and metabolic dysfunction, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and other developmental disabilities such as epilepsy, intellectual disability and learning disabilities. – The inclusion of autism as an outcome is desired. This review should also consider what impact the inclusion of Autism Spectrum Disorders (ASD) as an outcome would have on study designs and feasibility, as referenced in the IACC letter to NVAC. – This review should be conducted expeditiously, in a transparent manner, and involving broad public and stakeholder input.

So, as per a straight ‘vaccinated vs unvaccinated’ study, Ian Lipkin and NVAC Working Group agree that it can’t be done in the most scientifically accurate way and even if it could, it wouldn’t be ethical due to the requirement of excluding children from vaccination.

What they are saying is that a group like the IOM therefore should write up a feasibility study as to how such a study could be done. Without this, its extremely unlikely that a vax vs unvax study will ever fly.

Amusingly, the way that the NVAC Working Group words a possible solution – vaccinated vs unvaccinated via parental choice – sounds pretty much like the Generation Rescue phone survey. And we know how that ended up.

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Over the last few months David Kirby has been talking about a new paper that would be forthcoming that would postulate a link between autism and vaccines via Mitochondrial disease. He claimed to have some inside knowledge of this due to interviewing one of the co-authors.

That co-author was Richard Kelley and that paper has indeed been published prompting another excited flurry of posts from David on the Huffington Post. I know it was Richard Kelley as I’ve also been conversing with Dr Kelley via email. Following David’s initial post on the subject several months ago, amongst many other things Dr Kelley expressed:

...furor and frustration that we all feel right now is due to the very poor way in which this has been handled by several people each trying to claim an undeserved 15 minutes of fame.

It was easy to tell that here was a man who was immensely angry but was determined not to discuss any results – possible or actual – until they had gone through the rigour of peer review.

A day or so ago David published a post about this new study but I have to say that in my lowly opinion it left quite a lot unsaid and inflated the significance of what it did say.

David made much of key sentences of this paper (Cherry picking) and really the overall importance of it was a bit sidelined. For example, David says:

[This paper tackles]..The widespread misconception that Hannah’s case was “unique,” and without any bearing on other autism cases…

Whereas, the actual paper states:

Recently, there has been increased concern regarding a possible causative role of vaccinations in autistic children with an underlying mitochondrial cytopathy. For one of our 25 patients, the child’s autism/neurodevelopmental deterioration appeared to follow vaccination. Although there may have been a temporal relationship of the events in this case, such timing does not prove causation.

That one patient was, of course, Hannah Poling. Now, if there was ever ‘widespread misconception’ that mitochondrial autism was real (which I don’t believe there was) then this paper certainly adds weight to the argument that it exists. However, if David is trying to claim that this paper indicates that autism caused by vaccine fuelled mitochondrial disease is not unique to Hannah Poling then I think he has misunderstood or misread it. One out of twenty-five is pretty much the definition of uniqueness.

David then goes on to claim that this study gives weight to the claim that regressive autism is real. As it happens I agree with that. However, it should be placed in its proper context. David states:

Nearly all of the children in my book regressed into autism – a process that often began almost immediately after receiving multiple vaccinations.

Perhaps that is why the very idea of regressive autism has been cause for derision among many scientists, who insist that the parents were simply too ignorant to “notice” autism symptoms in their children earlier on.

That is, with due respect to David, simplistic and not representative of either data, or testimony. During the Autism Omnibus hearings, Professor Sander Greenland gave testimony (for the petitioners it should be noted) that clearly demonstrated that such scientists as Eric Fombonne clearly accept that regression exists and can possibly account for 28% of autism cases. Thats not exactly science being derisive of parents ideas about regression. However, it must be evaluated on a scientific case-by-case basis. As also testified to during the Autism Omnibus proceedings, parents who thought their child (Michelle Cedillo) had regressed were clearly shown to be in error when video evidence demonstrated obvious indicators of autism prior to vaccination.

However, David suggests that ‘nearly all’ the children in his book were regressive following vaccination. As Greenland showed during testimony. At most, this group of ‘clearly regressive autistics’ (autistic people who allegedly regressed following vaccines) could – at most – account for 6% of all ASD cases. If we take the numbers down to the sort of ‘low functioning only’ cases that I have heard many autism/vaccine believers in then we are down to 2% of all autism cases. This translates to approx 11,200 0 – 21 year olds in America. How this number constitutes an autism epidemic I have no idea.

David goes on:

Most of the children in my book – and Hannah Poling as well – had rather severe physical, biomedical problems associated with their regression. Again, this claim has been met with scorn by many in the medical and science communities, who say that autism is much more of a behavioral/neurological than biomedical condition. Parents and doctors who do try to treat these physical symptoms – with conventional and alternative therapies alike – are singled out for particular damnation by many of these so-called experts.

Firstly, I very much doubt that any parent who is treating a childs illness with conventional therapy has been scorned by anyone. There is however, no epidemiology that associates autism per se with the mainly toxicological and/or gastric issues most biomed parents talk about. The paper states:

Twenty-one patients (84%) had histories of major non-neurological medical problems, most commonly of the gastrointestinal system, with gastroesophageal reflux affecting nine and constipation affecting eight subjects.

The other ‘major non-neurological’ were things already associated with autism or other developmental disorders such as Prader Wili.

Lets also note that none of the symptoms listed by David would be treatable by chelation for example.

This study found 64% had GI dysfunction. This is very high and warrants further study, no doubt about that but…what relation has this to vaccines?

The claim that vaccines cause GI dysfunction revolves around the MMR hypothesis – a hypothesis that has taken an absolute battering of late. It has been established in clinical science that the findings of Wakefield et al cannot be replicated and the original findings that indicated a link were based on corrupt data. Of all the various vaccine hypotheses this is by far the weakest.

There is also the fact that the GI Symptoms listed in the study are common amongst a whole range of Mitochondrial diseases and thus its hard to see what particular significance they have to mitochondrial autism.

David goes on:

VACCINES MAY PLAY A ROLE IN AUTISTIC REGRESSION IN SOME CHILDREN WITH MITOCHONDRIAL DYSFUNCTION

“Recently, there has been increased concern regarding a possible causative role of vaccinations in autistic children with an underlying mitochondrial cytopathy (cellular disorder),” the authors wrote. “For one of our 25 patients [Hannah, who DOES have autism, contrary to claims by Gerberding, Offit et al, who erroneously insisted, without ever meeting the child, that she only had “features” of autism], the child’s autism/neurodevelopmental deterioration appeared to follow vaccination. Although there may have been a temporal relationship of the events in this case, such timing does not prove causation.”

Maybe not – but one must wonder, then, why medical personnel at HHS’s Vaccine Injury Compensation Program conceded that the “cause” of Hannah’s “autistic encephalopathy” was “vaccine induced fever and immune stimulation that exceeded metabolic reserves.”

Inserts are David’s.

Lots of things to cover here. Firstly, David says “VACCINES MAY PLAY A ROLE” whereas the study authors say: “..the child’s autism/neurodevelopmental deterioration appeared to follow vaccination. Although there may have been a temporal relationship of the events in this case, such timing does not prove causation.”

I think its pretty clear that the study authors are – at best – dubious that vaccines played a role. They are simply saying what the rest of us have always said: correlation does not equal causation.

David once again insists that HHS medical personnel “conceded that the “cause” of Hannah’s “autistic encephalopathy” was “vaccine induced fever and immune stimulation that exceeded metabolic reserves.”“

Where?

I asked twice in the comment thread that followed where this HHS document was and if we, the general public, could read for ourselves – and in context – these words. I am not suggesting David is lying at all. However, by his own admission David has been wrong more than once on what were previously firmly held opinions. This is nothing that should be being speculated about. We need to see this document.

Lastly, Gerberding, Offit et al were quite right to use the phrase ‘features of autism’. That is the phrase that both the HHS report and the case study (co-authored Jon Poling) used. Some say it is hair splitting but I don’t believe that saying someone has autism is the same as saying someone has features of autism. I’ve expounded on this before for those interested but suffice it to say I have a similar eye colour to Clive Owen. This doesn’t make me Clive Owen (much to my wife’s disappointment).

David goes on:

When I first reported this story, the researcher I spoke to told me there had been 30 children in the study, and two of them (8%) showed signs of brain injury from vaccines. Of the five children since excluded from the final published review, one must have been the second vaccine-related regression.

I very much think David might have been incorrect about that. I’m reasonably sure that Dr Kelley would not have referred to ‘brain injury from vaccines’. Given that the study he has just put his name to has cast doubt on that idea I don’t think its a valid idea.

There follows a series of what can only be called strawmen- this study didn’t do this, didn’t do that etc. For example:

....we now find out that nine of the children (36%) had so-called “multiple regressions,” and nothing in this review indicates that any attempt was made to determine if vaccines, febrile infections, or some other factors acted as triggers in the subsequent regressive episodes.

But in the sentence immediately before that David says:

Most of the children had regressed following illness-induced fever, the doctor told me.

The answer to the ‘question’ is right there. One regression, two regressions, twelve regressions – the Doctor states that regression followed illness-induced fever. In other words, given that these doctors know what caused the regressions why would it be necessary to look for something else? Something else that the authors have stated fairly clearly they don’t see any evidence for. However, as befits scientists discussing something both fairly new and of large public interest, they are careful:

Large, population-based studies will be needed to identify a possible relationship of vaccination with autistic regression in persons with mitochondrial cytopathies.

Thats fair enough I think. However I also think its going to be difficult. Sander Greenland made it very clear that detecting the hypothetical ‘clear;y regressive autism’ (i.e. autism caused by vaccines) was going to be next to impossible in large population-based studies, stating the the case amount was so small it would be pretty much undetectable by epidemiology. How to perform the kind of studies necessary to prove/disprove a relationship in such a small amount I have no idea. We’re basically trying to prove that vaccines trigger a mitochondrial cytopathy that leads to autism in – no matter what David thinks – is a pretty small group of people:

28% of people have a regressive form of autism. In 2003 at a LADDERS conference in Boston, Kelley postulated that 20% of regressive autism is due to mitochondrial cytopathies. CDC says that approx 560,000 of autistic people in the US are between 0 – 21. Therefore 28% of 560,000 = 156,800. 20% of 156,000 = 31,360. That’s about 5.6% of autistic children.

Rare? Not sure. Common? Hardly.

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Bob, Suzanne – welcome to the UK.

I read your interview in the Telegraph. Fascinating. I’d like to highlight a few points.

“We want the best minds in the world to focus on this,” says Wright. “And we want the UK to be a big player in the global movement.”

“Until now it seems to have passed under your radar,” adds Suzanne – a statement that could anger all the British activists who have been working in the field for decades.

Um yes, just a bit. You see, in the UK, we already have some of the best minds ‘working on this’.

And ‘passed under our radar’? One could assume that Suzanne Wright has a monumental gift for saying stupid things after reading that. Maybe she hasn’t heard of the National Autistic Society a parent founded organisation formed over 40 years ago in 1962. Maybe she hasn’t heard of it because it doesn’t cry about ‘the children’ all the time and because it recognises the fact that autistic people have a voice (no autistic people are on AS board whereas autistic people are represented at many levels of NAS) and are – in the main – adults and it tailors its aim appropriately. Whilst NAS is far from perfect it has learnt the necessity to respect autistic people for the fact that they are autistic. Something the Wrights aren’t even close to. If the Wrights want to get any traction in the UK they need to shut their mouths and listen to NAS.

And then the anti-vax rhetoric starts, giving lie to the idea that AS are pro-vaccine.

....The last vaccine Christian had before he regressed was MMR - that’s why my daughter concentrates on that. I don’t know whether his autism is linked: it was certainly coincidental, what we don’t know is if it was causal. Nor do we know whether the thimerosal (the mercury-based preservative used in vaccines) is a factor, although mercury is clearly poisonous. Governments want to run from that issue but they should become more aggressively involved. They have to follow children through to see if there are any effects.

Well Bob actually we do know if his MMR shot was causal. It wasn’t. We also do know if thiomersal is a factor. It isn’t.

I personally haven’t seen a government ‘running from the issue’. I’ve seen government spokespeople repeat what science tells us. There is no link. No matter how much people think there is or believe there is, based on the available evidence, there isn’t. Science has followed through to see if there were any effects. There weren’t. How much clearer does it need to be Bob?

Virginia Bovill perfectly sums up my own concerns about you and your wife’s organisation:

The other major source of concern is Wright’s focus on prevention and cure. This upsets Virginia Bovill, founder of TreeHouse, the charity hosting the lecture, who is currently studying for a DPhil on whether the quest to prevent and cure autism is morally justified. “Where would prevention lead – to ante-natal testing and abortion?” she asks. “The thought of a world without all the people I have met with autism is not a world I would want to live in. I would rather people said: ‘They are here, autism is here – how can we help these children fulfil their potential; how can we support their parents?’”

This is a very British pragmatism. The issue is right here and needs to be addressed. Do you want to help or do you want to force through your own beliefs simply because they are your beliefs? If the latter please just hop back on the plane. We don’t want you here.

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The thimerosal/autism study by Thomas Verstraeten is one of the big targets for those with the vaccines/mercury cause autism agenda. For what it’s worth, Autism’s False Prophets goes into the history of the Verstraeten study and clearly explains the history of that study.  Not surprisingly, the answer is somewhat different than you might find in, say, Evidence of Harm.

In his recent briefing on Capital Hill,  David Kirby took another jab at the Verstraeten study. He tried to assert that (a) the NIEHS claimed that the Vaccine Safety Datalink was unusable for autism studies and that (b) the CDC agreed. He was incorrect, and, luckily, a staffer caught Kirby at it.

Mr. Kirby is trying to explain his actions in a blog post in which he posts an open letter to that congressional staffer.

Let’s consider something here: the congressional staffer, an M.D., knew enough about the subject to catch David Kirby misquoting the NIEHS. I wouldn’t have been quick enough on my feet to catch the misquote.  Now, David Kirby wants to educate this gentleman. Frankly, the information should be flowing the other way. If Mr. Kirby had shown himself open to such education, say when EpiWonk made it abundantly clear (twice) what Mr. Kirby’s mistakes were, perhaps it would be worth the staffer’s time to discuss this with Mr. Kirby. That said, let’s take a look at Mr. Kirby’s letter.

In regards to Mr. Kirby’s misquotes, he has recently “clarified” his position.  He is writing to the Doctor who corrected him in his briefing here:

As you rightly pointed out (and as I concurred that day) I omitted an important detail in regards to Dr. Gerberdings’s letter to the Committee. I regret that, and never meant to mislead people in the room.

It was a rather artless sin of omission.

I think the lesson for me here is that, when you try to cram a two hour presentation into 25 minutes, it is wise to not include very complicated and, as you put it, “somewhat arcane” details that are difficult to explain in such a short period of time. In retrospect, I probably should have focused solely on the NIEHS report itself, and left the Gerberding letter out of the presentation entirely.

Mr. Kiby iscorrect, it is a confusing situation.  There are two documents—an NIEHS report and Dr. Gerberding’s response for the CDC. But, does that excuse misquoting the head of the CDC in his legislative briefing?

Here’s what David Kirby in his capital hill briefing “quoted” the NIEHS report as saying:

NIH: “We identified several areas of weakness that were judged to reduce the usefulness of the VSD for addressing the potential association between exposure to thimerosal and risk of ASD.”

That isn’t in either the NIEHS report or Dr. Gerberding’s response.  Here’s what Dr. Gerberding actually agreed to:

The panel identified several serious problems that were judged to reduce the usefulness of an ecologic study design using the VSD to address the potential association between thimerosal and the risk of AD/ASD.

Emphasis is mine.  But, we’ve already discussed that: Dr. Gerberding didn’t claim that the VSD has reduced usefulness in addressing the thimerosal/autism question. It made a claim that the ecological studies using the VSD had limitations. But, the recipient of Mr. Kirby’s letter would know that.

Back to Mr. Kirby’s open letter: David Kirby is now presenting his own interpretation of the NIEHS report, in place of Dr. Gerberding’s.

As I interpret things, the panel concluded that the database itself suffered from several weaknesses and limitations, which in turn reduced its usefulness for studies of autism risks from thimerosal (ie, Verstraeten) AND ALSO reduced the feasibility of future studies (ie, ecological ones) that are based on data collected within the VSD.

As EpiWonk aptly pointed out, Mr Kirby’s assertion is not the case. The NIEHS panel suggested a number of possible studies on autism using the VSD.  From the NIEHS report:

An alternate future study design that was viewed positively among panel members was a study of a high risk population, defined, in this instance, as siblings of individuals diagnosed with AD/ASD. A sibling cohort from the VSD would allow comparison of AD/ASD risk in siblings as a function of their thimerosal exposure through vaccination and the sample size would lend itself to supplemental data collection. A related study design based on sib-pairs or sets could be used to address discordant ASD/AD status in relation to thimerosal exposures. Another possibility that generated support by the panel was an expansion of the VSD study published by Verstraten et al (2004). The availability of several additional years of VSD data was seen as an opportunity to provide a more powerful test of any potential association between thimerosal and AD/ASD and would enable reconsideration of some aspects of the original study design (e.g., exclusion criteria). A related idea was to conduct a VSD retrospective cohort study using California-based MCOs linked with the California DDS, which would improve the diagnostic data and provide more complete ascertainment. For each of these designs, the ability to link medical records from mothers with those of their children was deemed critical.

As this reader interprets things, NIEHS seems to find that there is quite a bit of value in the VSD for studying autism, including an expansion of the Verstraeten study.

EpiWonk made the point first, but how can the NIEHS say that Verstraeten study design is not a good and that future use of the VSD is not useful, while at the same time suggest expanding Verstraeten?

The bottom line is that there are limitations to using the VSD alone in ecological studies of autism. One can overcome these limitations by going to chart reviews and other methods—as used in Verstraeten et al. and, more importantly, by VSD studies ongoing at CDC (one of which looks at autism).  As noted by Dr. Gerberding:

The VSD currently has a number of priority studies underway to address a range of important immunization safety questions, none of which utilize an ecologic study design. Instead, these current studies, including one study evaluating associations between thimerosal-containing
vaccines and autism, all evaluate individual-level data. This typically involves the review of individual medical charts to confirm the vaccines each individual received as well as the outcomes being studied. Studies using individual rather than group data provide stronger scientific evidence.

Mr. Kirby seems to be neglecting the fact that the CDC’s ongoing study (and the Verstraeten study) is not soley dependent on the VSD for the data.  He seems to be arguing that since the VSD, as a single data source, has limitations, the CDC can’t use it for any study. It’s like saying,

But, let’s take a closer look at what this says….and what Mr. Kirby is saying: The VSD on it’s own is not a good source of data to look at the thimerosal/autism question.

Now, anyone remember all the consternation that has been created by the fact that the VSD is not open to just any outside researcher?  Why should the VSD be opened to, say, Mark and David Geier?  Could they do the individual level data collection needed to make a VSD study valuable?

Apparently not. Recall this study by the Heather Young and the Geiers: Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink

This was a study paid for by the petitioners in the Omnibus proceding.   It, on it’s own, was bad enough that EpiWonk disassembled it.  Twice.

The recent Heather Young/Geier paper didn’t look at individual level data.  Any future study by the Geiers almost certainly wouldn’t as well.  Given the argument by the NIEHS, Dr. Gerberding…and David Kirby, the above study and any proposed study by the Geiers on the VSD would be useless.

Some how I doubt Mr. Kirby will make statements confirming that. But, I can’t see how he could hold any other opinion, given the arguments he, himself, has made.

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