New Study: Hepatitis B Vaccine Triples the Risk of Autism in Infant Boys

"The science is largely complete. Ten epidemiological studies have shown MMR vaccine doesn't cause autism; six have shown thimerosal doesn't cause autism."-- Dr. Paul Offit, "Autism's False Prophets"

"16 studies have shown no causal association between vaccines and autism, and these studies carry weight in the scientific industry."-- Dr. Nancy Snyderman, NBC Today Show Medical Editor

Conventional wisdom holds that the autism-vaccine question has been "asked and answered," and that at least 16 large, well-constructed epidemiological studies have thoroughly addressed and debunked any hypothesis that childhood vaccination is in any way associated with an increased risk for autism spectrum disorders.

But there are several critical flaws in such an oversimplified generalization, and they are rarely given close examination by public health experts or members of the media.

To begin with, it is unscientific and perilously misleading for anyone to assert that "vaccines and autism" have been studied and that no link has been found. That's because the 16 or so studies constantly cited by critics of the hypothesis have examined just one vaccine and one vaccine ingredient.

And, the population studies themselves have had critical design flaws and limitations.

The current US childhood immunization schedule calls for 28 injections with 11 different vaccines against 15 different diseases by two years of age. Of those 11 vaccines, only the Measles-Mumps-Rubella (MMR) shot has been studied in association with autism, (although a CDC study of an MMR-plus-chickenpox vaccine did show that the risk for febrile seizures in infants was doubled.) Meanwhile, those 11 vaccines contain scores of ingredients, only one of which, thimerosal, has ever been tested in association with autism.

It is illogical to exonerate all vaccines, all vaccine ingredients, and the total US vaccine program as a whole, based solely on a handful of epidemiological studies of just one vaccine and one vaccine ingredient. It is akin to claiming that every form of animal protein is beneficial to people, when all you have studied is fish.

Now, a new study has shown that giving Hepatitis B vaccine to newborn baby boys may triple the risk of developing an autism spectrum disorder.

An abstract of the study was published in the September, 2009 issue of the respected journal Annals of Epidemiology. In it, Carolyn Gallagher and Melody Goodman of the Graduate Program in Public Health at Stony Brook University Medical Center, NY, wrote that, "Boys who received the hepatitis B vaccine during the first month of life had 2.94 greater odds for ASD compared to later- or unvaccinated boys."

The conclusion states that: "Findings suggest that U.S. male neonates vaccinated with hepatitis B vaccine had a 3-fold greater risk of ASD; risk was greatest for non-white boys." The authors used U.S. probability samples obtained from National Health Interview Survey 1997-2002 datasets.

Critics will point out that this sample was limited to boys born before 1999, so the results are only applicable to that U.S. male birth cohort, and that the study's cross-sectional design limits inferences on causality. Another weakness is that the autism diagnoses were parent reported.

On the other hand, these results are generalizable to US boys age 3-17 born prior to 1999; vaccination status was confirmed through medical records; and there was controlling for confounders that may be associated with care seeking behaviors. (The P-value equaled 0.032) The full manuscript is currently under review by another journal.

Assuming that the full manuscript is published in a peer-reviewed journal, it will be among the first university-based population studies to suggest an association between a vaccine and an increased risk for autism. And that would be in direct contradiction to all those MMR and thimerosal studies that purportedly found no such link.

Does that mean that Hepatitis B vaccine causes autism? Of course not (though any relative risk above 2.0 is generally considered to prove causation in a US court of law).

But there are other studies, both published and greatly anticipated, which might support a hypothesized causal association between HepB vaccine and ASD, at least in boys.

Any day now, data culled from CDC's Autism and Developmental Disabilities Monitoring network (ADDM), is expected to be published in the Morbidity and Mortality Weekly Report, and the numbers are expected to put the rate of autism at around 1 in 100, or higher.

ADDM researchers examine the education and (when possible) medical records of all eight-year-old children in selected US cities and states. They look only at eight-year-old cohorts to allow time for all diagnoses to be made, reported and counted.

So far, ADDM has published data from just two birth cohorts: children born in 1992 (eight-year-olds in 2000) and those born in 1994 (eight-year-olds in 2002). The 1992 cohort revealed an estimated ASD rate of one in 166, or 60-per-10,000. (This has since been revised to 67-per-10,000, or one in 150).
For the 1994 cohort, the estimate was virtually unchanged, at 66-per-10,000.

But now that number is expected to exceed 100-per-10,000 for the 1996 birth cohort, born just two years later. The overarching question, of course, will be, "why?"

There are many possible explanations, though a 50% increase in just two years is astonishing, no matter what its cause.

One possible answer is the Hepatitis B vaccine, (which also contained 25 micrograms of mercury containing thimerosal up until 2002). Introduced in 1991, it was the first vaccine ever given on a population basis to newborn babies (within the first three hours after delivery) in human history.
But according to the CDC's National Immunization Survey, only 8% of infant children received the Hep B vaccine in 1992, when that birth cohort showed an ASD rate of 1-in-150.

By 1994, the number of children receiving Hep B vaccine had reached just 27% -- and the cohort showed a similar ASD rate, though it did go up by as much as 10% in some locations between the two cohorts.

But by 1996, Hep B coverage rate had risen to 82%. And that is the cohort whose ASD rate rose to around 100-per-10,000 or more.

Correlation, obviously, does not equal causation. But the uptake rate of that particular immunization is at least one environmental factor that did demonstrably change during the period in question.

In addition, some recent studies and Vaccine Court decisions have supported the contention that Hepatitis B vaccine can damage myelin -- the nervous system's main insulating component -- at least in certain genetically susceptible adults and infants.

A study published last October in the journal Neurology found that children who received the Hepatitis B vaccine series were 50% more likely to develop "central nervous system inflammatory demyelination" than children who did not receive the vaccine.

Most of this increase was due to the Engerix B brand of the vaccine, manufactured by the UK's GlaxoSmithKline. That brand increased the risk of demyelination by 74%, and patients with confirmed multiple sclerosis were nearly three times more likely to develop the disorder.

"Hepatitis B vaccination does not generally increase the risk of CNS inflammatory demyelination in childhood," the authors concluded. "However, the Engerix B vaccine appears to increase this risk, particularly for confirmed multiple sclerosis, in the longer term. Our results require confirmation in future studies."

Let's hope that future studies of neonatal HebB administration, demyelinating disorders, and ASD are completed as quickly as possible.

 

 

Comments

[RealistReader]

Sigh. I am intrigued by data studies of these kinds, but would like to see them refined. I would also like to see them broadened beyond vaccines, which I think of as "pop" reasoning. What else was happening in 1996? A surge in cell phone use, and all the towers that were rapidly constructed to accommodate demand. Is this being studied? What about continued genetic modification of food? What about development and prevalence of new and different pesticides used on foods which mothers ate and --- yes, the antibiotics, vaccinations, and chemicals fed to the meat we (especially pregnant mothers) consume. What about local drinking water and the chlorine used to "purify" it? It seems I hear all about mercury in fish and thimerosal and the listeria in all sorts of things that women should avoid while carrying a fetus...it seems I read all about those concerned about vaccination... but are these other environmental concerns being studied *specifically* in relation to ASD?

Cut me at least a tiny bit of slack-- we are expecting our first and may be behind the learning curve here.

[dugmaze]

Thanks David for doing the work you do. Your articles are having an impact and saving lives or preventing damage.

[Josephius]

Really?! Do you have ANY evidence to support that?

...didn't think so.

[ObjectiveAutismDad]

Why are you being abusive -- again??? David Kirby has had an impact. More people are aware of these issues because of him. Many of them have discovered that there are therapies and treatments that are helping our children -- because of his reporting. Why are you so obviously opposed to people making progress with their children?

And, please, spare us your self-righteous crap about how we don't have any "proof" that our children are making improvements. Many of us have spent many, many years trying to make small improvements in our childrens' lives. Now more and more are making progress.

I'm guessing that you'll persist -- which only makes neutral observers more sympathetic to us. Thanks for that.

[dugmaze]

JoJo, your response is my proof.

[Josephius]

Didn't read the study again David? You're deriving (suggesting) a conclusion strictly from an abstract? Not a good idea, especially since you are basing quite a bit on the work performed by a single graduate student and her P.I.

A p value of 0.032....and you think this is reliable? Wow!

I for one an not going to jump to any conclusions until I actually read and evaluated the work.

[ObjectiveAutismDad]

Sigh... 0.032 is less than 0.05 (the confidence interval) -- which generally means the results are significant.

[Josephius]

And you would consider those results robust? I don't. And that's probably why they won't be published in anything above a 3rd tear journal...if it is published.

[Peakdavid]

JoJo:

How will the conclusions in the published abstract differ from the conclusions in the published article?

How is the validity or the invalidity of a study affected by the fact it was performed by "a single graduate student and her P.I."? A scientific study stands on its own. An evaluation of its validity should no more be affected by the initials after someone's name than the color lab coat they were wearing.

Seems you're getting desperate. What's next: "Ignore this study about a link between autism and vaccines because it was published in journal that was saddle stitched, not perfect bound!"

Your purpose here is to kill with a thousand cuts without engaging in a substantive discussion with Kirby. You do notice, don't you, that he ignores you?

And please learn to spell "tier."

[ThoJ]

"Your purpose here is to kill with a thousand cuts without engaging in a substantive discussion with Kirby. You do notice, don't you, that he ignores you?"

Does Kirby respond to anyone?

It would be good if he did. For example, he could correct you, Peakdavid. The abstract is *not* the abstract of an article. It is the abstract of a poster from a conference. The paper wasn't even submitted to the same journal as the one where the abstract was published.

The abstract was not peer reviewed. The poster was not peer reviewed.

If (and that is a big if) this paper gets published, it could very well be different from the abstract--peer review does that.

[mikies]

Why is it that the science of discovering injuries and adverse effects, especially with vaccines is done after the cows have left the barn.......after the vaccine manufacturers have made their profits, after all those connected to this scheme have immunity.

It's way past time to slam the door on vaccine manufacturers. End their immunity from prosecution. They are the embodiment of scientific misconduct and corruption.

[sandygottstein]

Thanks, David, as always great work. I would like to add a couple of points. First, it doesn't matter if it is 16 or 1600 studies exonerating mercury (or whatever), if the studies are poorly designed. And those conducting the studies have ample reason to design them specifically to exonerate the vaccines, not the least of which is enormous liability. Others have examined the studies; here is my take on one of them: "Scandals: Vaccinations - Garbage In/Less Than All The Garbage Out?" http://www.vaccinationnews.com/Scandals/2003/Jan_17/Scandal51.htm. This is but one small example of how sloppy the "research" is.

Second, there are other possible culprits that have barely been addressed, in spite of official hints of a possible link. For instance, autism is acknowledged as a consequence of rubella (http://www.vaccinationnews.com/Scandals/July_17_02/Congenital%20Rubella%20Symptoms.pdf), this from the textbook "Vaccines". I wrote about this issue once in 2002, updating it a bit in 2003, wondering if rubella vaccine might also play a role: http://www.vaccinationnews.com/Scandals/2003/Dec_2/Scandal67.htm

Until and unless research is conducted that is honestly concerned with what causes autism, rather than specifically designed to disprove any links with vaccines, we will never know the truth. And it ain't gonna happen 'til we make it happen.

[CraigWilloughby]

How did they adjust for confounders? I really wish I could see more than just the poster for this study. I'd like to know how they got their numbers. It just seems like the sample size they have is pretty small.

[Josephius]

"How did they adjust for confounders?"


" Logistic regression modeling was used to estimate the effect of neonatal hepatitis B vaccination on
ASDrisk amongboys age 3-17 years with shot records, adjusted for race, maternal education, and two-parent household. "

[CraigWilloughby]

Ok, so the survey was for kids ages 3 to 17, right? Any of the 8 to 17 year olds would have been born before the HepB vaccine was introduced, so they would not have received the vaccine, am I correct?

And only 33 autistic children? That is a pretty small sample size.

[Peakdavid]

This should be fun.

As the studies and legal settlements continue to confirm the relationship between vaccines, ASDs and susceptible children, the usual suspects will be here saying the usual things summed up by Kirby's quotes from Offit and Snyderman.

It's getting to that point that such folks sound like the non-swimmer about to go down for the third time yelling,

"Water does not cause drowning!"

[Garbosmed]

Of the two stand-alone Hep-B vaccines on the current schedule, only Energix contains both aluminum and thimerosal. (Per FDA excipient table: Hep B (Engerix-B) Aluminum Hydroxide, Phosphate Buffers, Thimerosal*, Yeast Protein). The Material Safety Data Sheet for thimerosal explicitly states (under the section on Reactivity) that it is not to be combined with aluminum.

I have not been able to get an answer from FDA or HHS/CDC on who, when, why and how they came to the conclusion that it is safe to put these two substances in the same vaccine and inject it into hours-old babies -- or anyone else, for that matter.

The other vaccines containing both aluminum and thimerosal are:
Twinrix, Tripedia, TriHIBit, DT (sanofi), Td (Decavac) and Td (Massachusetts).

[foe2Hg]

My severe asd daughter had all Energix, HepB vaccines 16 years ago. Thank you, David for reporting on the continual science. It is important and valuable that we collect this data yet it is so heart breaking.

Teresa

[Josephius]

"The Material Safety Data Sheet for thimerosal explicitly states (under the section on Reactivity) that it is not to be combined with aluminum."

Where does it say that?

http://www.sciencelab.com/xMSDS-Thimerosal-9925236

[dugmaze]

"California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer, birth defects or other reproductive harm, which would require a warning under the statute:"

And the CDC recommends this stuff to pregnant women and babies?

[Mom23boys]

Well blow me over with a feather. Next we're going to find out that smoking causes lung cancer.

[dugmaze]

But people still smoke!

[bluevalentine]

As always, DK, THANK YOU!!
The very idea of vaccinating a newborn for NO BENEFIT to the child on the first day of life is INSANE!!!!!

This should NEVER have happened. There is NO risk vs benefit ratio in favor of vaccinating for Hep B within hours of birth. There is ONLY RISK!

If for no other reason than to err on the side of caution...Hep B should NEVER have been added to the mandatory schedule for you children. And without question the very day they are born.

[SoFlaParent]

Thank you Mr. Kirby.

There are alot of parents out there (myself included) with children born relatively closely toether who now notice the difference in the way the HepB series was started in older children compared to younger children in the same family. It's particularly striking when you notice how much sicker a younger child is compared to the older one who didn't start the series until 4 months of age (whereas younger sib started series at birth).

It's hard to not wonder why the schedule recommendations were changed in such a stealth fashion and in a relatively short period of time.

[usna73]

My son was born in 1992 with jaundice. We asked about the advisability of giving the Hep B at birth. He was vaccinated with Hep B twice in the first 60 days and then again 5 months later.

We are currently in US Court Of Federal Claims in the procedural portion.

We became convinced in 2001 of the fact that he was injured for life from those vaccines and we continue to be certain of it.

We will never rest until justice is done.

[ObjectiveAutismDad]

David, Thanks again for staying on top of this issue for us. Hopefully more will be learned as additional work is done in this area.

[BlackJAC]

It is also illogical to reflexively revert to the right-full-rudder of Vaccines Cause Autism based solely on sequence of events. Can we please have some actual scientists work this problem?

[Doybia]

BlackJAC, we would all love to have some actual scientists work this problem? But are you implying that these folks at Stony Brook are not scientists? On what basis?

[CraigWilloughby]

Quite polite for one of your posts, I admit. Who do you think this study that Mr. Kirby referenced was done by if not by actual scientists?

[foe2Hg]

BlackJAC-

Interesting that you go on the offense instead of just acknowledging the facts. The authors do suggest more science to confirm this:

"Hepatitis B vaccination does not generally increase the risk of CNS inflammatory demyelination in childhood," the authors concluded. "However, the Engerix B vaccine appears to increase this risk, particularly for confirmed multiple sclerosis, in the longer term. Our results require confirmation in future studies."

This IS science but everyone would welcome more. This should open doors for more research into a vaccinated vs unvaccinated study.

[AutismNewsBeat]

How many kids do you suppose would be needed in each group to get statistically meaningful data? How great of a difference between the two groups would you need to detect? 10 percent? 20 percent?