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Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s. TACA does not engage in lobbying or other political activities.

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TACA E-Newsletter

September 2009 #2

Here is your update on TACA (Talk About Curing Autism). If you are new to our site... WELCOME! This newsletter is produced two to four times each month.

We are an autism education and support group. We want to make this e-newsletter informative for you. As always, contact us your thoughts and/or questions so we can improve it.

We focus on parent information and support, parent mentoring, dietary intervention, the latest in medical research, special education law, reviews of the latest treatments, and many other topics relating to autism. Our main goal is to build our community so we can connect, share and support each other.

Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s.

1. Find a TACA Meeting

Come to a TACA Meeting!

TACA holds monthly meetings in many locations throughout the United States that feature educational speakers on important topics and allow family members to connect with one another and stay on top of the latest information in the autism world. Each TACA group maintains a resource library of the latest autism books, CDs and DVDs that can be checked out by members at no charge.

Check out our group listings: each contains information on TACA meetings and special events as well as a contact form.

Are you wondering what happens at a TACA meeting? Watch our video.

2. Real Help Now Conference - Online Registration Ends October 2!

Listen, Learn & Take Action for Your Child at the Real Help Now Conference

Saturday, October 3, 2009 • 8:30 a.m.-5 p.m.

Searching for and finding the right information to help your child can be overwhelming for families affected by autism. The Real Help Now Conference was developed to bring the latest information on medical, dietary and legal issues for children with autism, and most importantly, help parents through the often daunting process of determining how to organize and prioritize their intervention efforts.

The Real Help Now Conference will provide two important tools for translating the information gained from the speakers into action for your child:

1. Real Help Now Workbook with step-by-step processes to help you to determine appropriate interventions and timelines for taking action in the realms of medical and dietary intervention, education, finances and home life. (Sorry, this Workbook is only available at the conference.)

2. TACA parent mentors who have been there, done that. Our experienced mentors will be on hand to to work with you one-on-one to answer your questions and share what has worked for their child.

Whether you are just starting out on the autism journey or are an experienced parent, you will learn from nationally known experts about how you can help your child at the Real Help Now Conference. Our speakers include:

• Lisa Ackerman, TACA Founder & Executive Director
• Timothy A. Adams, Esq., special education attorney
• Lynne Arnold, TACA mom
• Koren Barett, ND, naturopath and DAN! doctor
• Michael Giammatteo, TACA dad
• Moira Giammatteo, TACA mom
• Jerry Kartzinel, MD, internationally known author, lecturer, and clinician
• Doris Rapp, MD, author of "Is This Your Child?"
• Cindy Schneider, MD, DAN! doctor

Register now online and save on early registration!

• Parent Registration: Individual, Couple with One Guide, Couple with Two Guides
• Professional Registration
• Exhibitor/Sponsor Opportunities

Complete conference information

3. Join Us for Coffee Talk!

Come and receive some extra support or to chat all topics related to autism and meet other TACA families at these informal, monthly get-togethers.

› Bakersfield, CA
› Inland Empire, CA
› Los Angeles, CA
› Orange County, CA
› Visalia, CA
› Indianapolis, IN
› Glen Burnie, MD
› Gaithersburg, MD
› Hamilton, NJ
› Las Vegas, NV
› Ardmore, PA
› Exton, PA
› Tullahoma, TN
› Virginia Beach, VA
› Fitchburg, WI

4. 93.1 Jack FM & TACA Are Back for Jack's Fourth Show

Culver City - The Dumpy Little Building is again mildly ecstatic to tell you about JACK’S FOURTH SHOW! It’s JACK’s fourth concert (hence, the name) starring a bunch of bands and will be on stage for your viewing and listening pleasure Saturday, October 10, 2009 at Verizon Wireless Amphitheater in Irvine, CA.

The amazing band line up includes: Foreigner, Joan Jett & the Blackhearts, B-52’s, Eddie Money, Ratt, Missing Persons and George Clinton & Parliament Funkadelo.

Get Your Tickets!

• See ticket info at www.931jackfm.com
• Jack’s VIP Pit Tickets (similar to the first 3 shows) on sale October 7 at 9 a.m.

Like Jack's First, Second and Third Shows – the Fourth Show will benefit Talk About Curing Autism (TACA) - families with autism helping families with autism. TACA currently serves almost 15,000 families affected by autism – for free.

From this concert announcement – The JACK Team got creative and spawned several ways for raising funds and awareness for TACA Families!  Efforts include:

• $1 from each ticket sold go to TACA
• Autism awareness mixed in with concert announcements spots
• 50 pairs of VIP Pit Tickets that directly benefit TACA –  Please contact Lisa Ackerman for to be sent direct announcements on this presale
• A great show for 16,000 music enthusiasts!

Read past years "How Has TACA Helped Your Family?" winning essays.

Read about TACA’s mission and accomplishments here.

What has JACK FM & TACA accomplished together?

Since 2006, Jack FM & TACA have partnered together in four separate events including: Jack's First Show, Jack's Second Show, Jack's Third Show and the Jack Open Golf Tournament. 'TACA has greatly benefitted from being included in these Jack FM activities.

At these events, we touched over 48,000 people with the event announcements, the TACA message, and autism awareness. And countless others heard the event announcements via radio spots on Jack FM. In three years, almost $168,000 has been raised to help families affected by autism with much needed programs and services.

All these events have had the Jack FM signature of fun while educating and helping to fund necessary programs to families affected by autism. This partnership has been incredibly successful for TACA.

Tickets for this one of a kind event go on sale September 11th! Get ready for a great band line up and help a great cause by checking out www.931jackfm.com for more details.

Special thanks to JACK FM FOR SUPPORTING TACA FAMILIES for FOUR YEARS! The support for families affected by autism is needed and greatly appreciated!

5. Special Education Law Analysis: Recent Supreme Court Decision

By Maryam Mojgani, Esq., Attorney/Advocacy Program Coordinator for TACA

This summer the Supreme Court ruled on a case involving an intrusive strip search of an Arizona middle-school student by school officials. While this case is not regarding special education law specifically, it is a very interesting case that addresses a child’s constitutional rights and the potential civil liability of school officials for actions they commit during the scope of their employment. This would be one of the final decisions from Supreme Court Justice David Souter before his retirement.

Stafford Unified School District v. Redding

Facts of the Case

Thirteen-year-old Savana Redding was strip searched by school officials from the Safford Unified School District in Safford, Arizona. Another student in her school had been caught with ibuprofen pills and said they belonged to Savana. Savana was questioned by an assistant principal who along with a school secretary, searched her backpack, but found no pills. Savana was then taken into a private room where a school nurse and the secretary performed a strip search in which they asked her to pull her underwear and bra aside exposing her private parts. Despite this search, the administrators found no drugs.

Upon learning what had happened, Savana’s mother sued the school system, the assistant principal, secretary, and school nurse, claiming that her daughter’s Fourth Amendment constitutional right had been violated by the search. 

The courts had to look at two major issues in this case. The first was whether Savana’s Fourth Amendment constitutional right had been violated. The second was whether a school official is entitled to qualified immunity for the actions they commit in the scope of their employment by the School District.   

The Fourth Amendment protects individuals from unreasonable searches and seizures.  However, the qualified immunity doctrine protects public officials from liability or civil damages for the conduct they commit within the scope of their employment. This protection is available as long as the conduct does not violate clearly established statutory or constitutional rights of which a reasonable person would have known.

Procedural History

A federal district judge dismissed this suit, an appeals panel agreed with that dismissal finding that the young girl’s rights were not violated. Upon rehearing, a full panel of the Ninth U.S. Circuit Court of Appeals reversed stating, “there was an invasion of a constitutionally obtained right”, and furthermore, that the Assistant Principal Wilson could be personally liable for his actions.  The school district then appealed to the Supreme Court which granted a petition for certiorari to review the case.

Holding

The United States Supreme Court held unconstitutional the strip search of the student, stating that, in this instance, a strip search violated the child’s fourth amendment right to be free from unreasonable searches and seizures. However the court did not issue a clear prohibition against strip searching children at school, and left open the possibility that such searches could be permissible under a different factual scenario. Additionally, the Supreme Court held that the school officials, and specifically the assistant principal who ordered the search, were immune from personal liability for their actions.  

Justice Souter explained in his holding that under the court’s precedent in New Jersey v. T.L.O, school officials were justified in searching the girls backpack and outer clothing, but anything more was excessive. As for the question of qualified immunity, Justice Souter argued that the lower court’s interpretations of T.L.O. and other similar cases varied to the extent that Assistant Principal Wilson had inadequate notice regarding Savana’s situation. As a result, ambiguity was created and the school officials who ordered the underwear search did not violating any “clearly established laws.” 

Although the Supreme Court found that while Stafford officials violated Savana’s constitutional rights they remanded the case to the lower court to decide how much, if any, the district would be held financially liable for in this incident.

Importance of the case

While this case seems like it was a victory for civil libertarians and parents, it falls woefully short of providing clear guidance for future cases. Furthermore, the court did not ban the use of strip searches on school campuses, nor did the Supreme Court provide any clear guidelines about when a school official will be justified in conducting a strip search. As a result many people predict that there will be more litigation on this issue before it is resolved. Unfortunately, this means that more children will be subjected to unreasonable searches and seizures and administrators conducting those searches might continue to escape personal liability.

Read the full text of the Supreme Court decision.

6. Daily Autism Updates for Families

All news related to autism:  

For daily updates to all autism legislative issues: ChangeforAutism.org

AgeofAutism.com

7. Using the Gluten, Casein and Soy-Free Diet for Children with Autism

The week of September 20 is Autism Awareness Week at DietsInReview.com.

Guest Blogger Holly Bortfeld is a work-at-home mom to two children with Autism Spectrum Disorder (ASD), ages 14 and 16. She home-schools her son and writes content for the Talk About Curing Autism (TACA ) site, including the popular series, “Autism-On-A-Budget.” Follow Holly on Twitter @TACAnow.

My son has been on the GFCF diet since 1998. Back then, there was little available as far as information, research or foods that didn’t taste like cardboard. Happily, you can now find an extensive array of mixes and pre-packaged foods now in grocery and health food stores, as well as online grocers.

Why should you do the diet? Because it works! According to the American Academy of Pediatrics, at least 70% of children with ASD have gastroenterological problems and both published and anecdotal research shows diet to be the single-most effective treatment used with Autism Spectrum Disorder (ASD) kids.

Almost all families who come to TACA for diet information report the same thing – “My child only eats a few foods, he’s very picky-eater.” Rarely are any of those foods protein or vegetables and almost none are nutritional. The sensory defensiveness that many ASD children exhibit is vastly heightened before the diet and texture becomes a roadblock to healthy eating as well. Once they are on the diet however, they expand their food choices to include more healthy choices, thus improving their nutrition.

The most common things parents report after their child is fully on the diet is that “he came out of the fog,” started talking, started sleeping, stopped getting sick all the time, the tantrums decreased dramatically and the diarrhea stopped.

For my son, all of those things happened but something else too, his therapies began to work. Before the diet my son had a one-on-one, in-home, 40-hour a week program for months. The problem was that he didn’t seem to know they were there. Once we implemented the diet, it was as if he woke up and said “Oh, you want me to do this? Sure, why didn’t you say so?”

Some people worry that the diet is too expensive, but the diet is only as expensive as you make it. Any diet is expensive if you buy a lot of pre-made foods. TACA has two great articles to help: “GFCFSF on a Budget” and “GFCFSF Diet on Food Stamps.”

Try the diet, you won’t regret it. Your child deserves it!

8. Fox News: Infectious Disease Expert Won't Give H1N1 Vaccine to His Kids

When asked about whether he would give the Swine flu vaccine to his children, infectious disease expert Dr. Kent Holtorf responded, "I definitely would not." Watch the video to see his comments on the toxicity of thimerosal and link to autism.

9. Without Consent: Squalene in Vaccines

Veteran reporter Gary Matsumoto has just launched a website that educates and informs individuals about the toxicity of oil based adjuvants (squalene) in vaccines and the association of adjuvants to auto-immune disorders. He also takes a deep look into the "informed consent" issue surrounding vaccination today. For more information: www.without-consent.com

10. New Research Study Shows Developmental Delays in Monkeys Given Hepatitis B Vaccines

From Thoughtful House:

Sept. 30, 2009

(Austin, Texas) - A new research study published today in a leading scientific journal, NeuroToxicology, found that a Hepatitis B vaccine containing the mercury-based preservative thimerosal caused significant delays in the acquisition of critical survival reflexes in newborn rhesus macaque monkeys. In this first-ever study comparing vaccinated animals with unvaccinated controls, thirteen of the animals were given a Hepatitis B vaccine containing a standardized amount of thimerosal to match that given to babies; four received a saline placebo, and three were not given any shots. The unvaccinated animals developed normally. Delays in vaccinated infants involved three critical reflexes associated with feeding, which are essential for survival in the wild.

"Infants of lower birth weight and gestational age were at greater risk" explained Dr. Laura Hewitson of the University of Pittsburgh, one of the principal investigators of the study. "The reflexes affected in this study are controlled by the brainstem, which regulates functions like heart rate, breathing, and intestinal activity, so these findings give us cause for concern, especially for low birth weight and pre-term infants who might be more susceptible to functional brain injury from this vaccine."

According to Hewitson, the study was not designed to determine whether it was the thimerosal preservative or another component of the vaccine that caused the observed delays. Although the FDA and American Academy of Pediatrics recommended in 1999 that thimerosal be removed as soon as possible from vaccines in the US, it is still used as a preservative in flu shots, including the recently licensed H1N1 vaccines. Flu shots are currently recommended for pregnant women and children 6 months of age and older.

"We undertook these experiments largely because we were unable to find any safety studies comparing vaccinated and unvaccinated animals," said Dr. Andrew Wakefield, Executive Director of Thoughtful House and a co-investigator of the project. "This study is part of a larger research program looking at the safety of the vaccine schedule from birth to age four years. What is particularly concerning is that in spite of the recommendation to remove thimerosal from vaccines a decade ago, millions of people, many of them children and pregnant mothers, are about to get mercury in their flu shots."

Thimerosal is also still routinely used in Hepatitis B and numerous other vaccines world-wide.

11. Blockbuster Primate Study Shows Significant Harm from One Birth Dose of a Mercury-Containing Vaccine

By Mark Blaxill

A research team led by scientists from the University of Pittsburgh and Thoughtful House reported today that exposure to a birth dose of a hepatitis B vaccine that included an ethyl mercury preservative caused significant delays in the development of several survival reflexes in male rhesus macaque monkeys. The findings were published on line today in the journal Neurotoxicology. [See the abstract below and the journal link HERE]

In the first safety study of its kind of the hepatitis vaccine birth dose, the researchers showed that male macaques vaccinated at birth with a hepatitis B vaccine (HBV) took more than twice as long as unexposed macaques to acquire three standardized skills typically used to measure infant brain development. The thirteen vaccinated monkeys each received a dose of Merck’s Recombivax® hepatitis B vaccine to which a weight-adjusted amount of the ethyl mercury-containing vaccine preservative thimerosal had been added (each dose included 2 micrograms of ethyl mercury as opposed to the human infant dose of 12.5 micrograms). Seven unexposed monkeys received either a saline placebo injection or no shot at all.

Over a two week period following birth, the researchers examined the infant macaques daily for their ability to perform nine basic reflexes (four reflexes were tested in two ways, so the paper reports thirteen performance results). Three of nine reflexes showed significant delays in vaccinated macaques while two other reflexes were delayed and “approached significance.” As for the three significant reflexes, vaccinated macaques learned more slowly to: 1) turn their head in response to a brush on the cheek (the root reflex); 2) open their mouth in response to a brush on the forehead (the snout reflex); and 3) suck on a nipple placed in their mouth (the suck reflex).

Although the paper is carefully worded and the results reported modestly, these findings are certain to receive intense scrutiny. For while hepatitis B vaccines currently produced in the United States no longer contain thimerosal, the vast majority of American infants born during the 1990s received a vaccine formulation similar to the one the thirteen vaccinated macaques received. In addition, thimerosal-containing HBVs are still routinely administered to newborn infants in developing countries such as Brazil. Consequently, the finding that early exposure to potentially toxic vaccine formulations can cause significant neuro-developmental delays in primates has explosive implications for vaccine safety management. These implications go far beyond the domestic HBV program and raise concerns about HBV formulations sold abroad as well as the domestic influenza vaccine program. Most influenza vaccines, including the vaccines in the upcoming swine flu program, contain thimerosal and are routinely administered to pregnant women and infants.

According to Dr. Andrew Wakefield, Executive Director of Thoughtful House and a co-investigator of the project, “What is particularly concerning is that in spite of the recommendation to remove thimerosal from vaccines a decade ago, millions of people, many of them children and pregnant mothers, are about to get mercury in their shots. Thimerosal is still routinely used in Hepatitis B and numerous other vaccines world-wide. ”

The authors are careful to point out several limitations of their analysis. According to the paper, “our study design does not enable us to determine whether it is the vaccine per se, the exposure to [thimerosal], or a combination of both that is causing the observed effects. “ In addition, the effects appear in some reflexes to be mediated by other risk factors such as birth weight and gestational age, suggesting that vaccinating premature and/or low birth weight infants may create especially high risk. “Infants of lower birth weight and gestational age were at greater risk” explained Dr. Laura Hewitson of the University of Pittsburgh, one of the principal investigators of the study. “The reflexes affected in this study are controlled by the brainstem, which regulates functions like heart rate, breathing, and intestinal activity, so these findings give us cause for concern, especially for low birth weight and pre-term infants who might be more susceptible to functional brain injury from this vaccine”.

Despite their interest in the brainstem, the authors note that the “the mechanism of these effects and the requirement for [thimerosal] is not known and requires further study.” At least some of that further study is underway. According to Wakefield, “This study is part of a larger research program looking at the safety of the vaccine schedule from birth to age four years.”

In fact, some findings from the group’s own further study may already be at hand. Close reading of the published paper reveals that these macaques were followed for only fourteen days from birth for adverse responses to HBV because “infants received further interventions on Day 14 which would have confounded the independent effects of the HB vaccine.” These further interventions were most likely additional vaccinations. Over a year ago, Age of Autism reported on a series of abstracts presented at an autism conference by many of the same authors (see HERE). These abstracts describe a study design in which multiple vaccines were administered, in addition to HBV. The current study design appears similar to the earlier reports, but differs from the previous abstracts in the number of vaccine exposures (one vs. multiple, including MMR) and the number of unexposed macaques (three vs. seven).

Careful methods, conservative findings

Basic reporting aside, it’s worth digging a bit deeper into some of the details of the study design, which will almost certainly attract further attention. There are numerous elements that go into a primate study like this, elements that can and should influence the scientific acceptance of the results. These include: the quality of the primate lab and research group, the quality of the study design and testing methods, the size of the sample, the authors’ statistical interpretations and potential biases.

Primate research expertise. The macaques were bred and housed at the primate nursery of the Pittsburgh Development Center (PDC) at the University of Pittsburgh, where the research team’s principal investigator, Dr. Laura Hewitson, is a member of the faculty. The PDC is a part of the Magee Women’s Research Institute of the University of Pittsburgh’s School of Medicine. PDC’s research mission includes stem cell development and infertility in addition to an infant development research program of which the Infant Primate Laboratory headed by Dr. Hewitson is the driving force.

The PDC was founded in 2001 and its primate program is relatively new. But the director of the PDC, Gerald Schatten, came to Pittsburgh from Oregon National Primate Center, one of nine National Primate Research Centers (NPRCs) sponsored by the National Institutes of Health (NIH). In addition, the vaccine study’s PDC team has benefited from the direct involvement of two of the most prominent primate researchers in the nation. The late Gerald Ruppenthal was an active collaborator of the PDC and in that capacity also “assisted in the [vaccine] study design, training and implementation of the infant primate developmental measures prior to his death in 2004.”

Perhaps most importantly, one of the vaccine study co-authors is Dr. Gene Sackett, who was once director of the University of Washington’s Infant Primate Research Laboratory, another one of the nine NIH primate centers (now headed by Dr. Thomas Burbacher). He is now Professor Emeritus at the University of Washington. Along with Ruppenthal, Dr. Sackett was co-editor of one of the most widely used texts for primate research, Research Protocol and Technician’s Manual, published in 1992.

In short, while the PDC is a relatively new primate facility, both the PDC primate facility and the vaccine study team have benefited from the active support and participation of the country’s leading primate experts.

Study design and testing methods. The study was carefully designed and tightly controlled to prevent bias from entering into any of the assessments. Crucially, the exposure status of the macaques was not known to the team. “Neonatal assessments were performed by [Lisa A. Houser] who was unaware of the study group assignment of each animal, the number of animals in each study group and the number of study groups.” Adding rigor to the implementation of the testing, Houser “underwent extensive training” in making these assessments by the leading experts in the field, Gerald Ruppenthal, before his death.

In addition to Ruppenthal’s involvement as a trainer, Dr. Sackett’s involvement as co-author and data analyst ensured that Houser’s data collection was sound. Dr. Wakefield and Dr Hewitson designed the study, but neither was involved in data collection or statistical analysis. Dr. Wakefield’s role in the ongoing autism-vaccine controversy may make the design subject to added criticism; at the same time, it provided added incentive to make the design impervious to superficial criticism.

Sample size. At first glance, the number of infant primates involved, thirteen vaccinated macaques and seven unexposed (the paper avoids using the word “unvaccinated” to describe the latter group since four were injected with saline placebo and three received no shot at all) may seem low. Some might offer the concern that this sample is too small to draw strong any strong conclusions, but this would reflect ignorance of how primate research is typically conducted. Unlike rats and mice, which can be bred in laboratories in relatively large numbers, primates are expensive to raise. And since the purpose of study designs involving infant primates is to infer human exposure risk from the developmental outcomes of our closest animal relatives, the testing protocols are designed to be sufficiently precise so that valid conclusions can be drawn from small numbers of animals.

In other words, the sample is sufficiently large for a study of this type, especially since only two exposure groups were studied. In addition, all 20 macaques described were male, eliminating any confounding effect of gender and further raising the statistical power of the sample.

It’s worth comparing the size and composition of these study groups to that of two comparable research projects that have been frequently cited and widely accepted as sound. In the first of these, published in 2005, Dr. Thomas Burbacher, from University of Washington’s NPRC, led a study team that examined the effects of thimerosal and methyl mercury in infant primates. In this study, Burbacher’s team examined a different species of macaques in a mixed-gender sample that included seven controls and seventeen animals in each of the two (thimerosal and methyl mercury) exposure groups. The total study involved 41 infant male and female macaques. In a second comparable project, Dr. Burbacher published an influential series of studies on the effect of subclinical methyl mercury exposure, spanning five papers published from 1994-96, in adult macaques. His study sample examined multiple exposure groups with five female macaques in each group and only four unexposed females. The total study involved 27 adult female macaques.

It’s worth noting that the seven unexposed macaques reported in today’s paper represents an increase in unexposed animals relative to the three animals in the conference abstracts published last year. Last year’s control group was similar in size to the 1994-96 Burbacher control group (three infant males vs. four adult females) but may have raised concerns over adequate sample size. The current study’s unexposed population is equal in size to Burbacher’s infant (but mixed gender) 2005 control group and larger in size than the 1994-96 control group of adult females.

When considering both the confounding effects of gender and the number of animals per exposure group, today’s study compares favorably to both of these prior studies, with more gender specific controls than either of the Burbacher studies and more animals of a single gender in the main exposure group than either study as well.

Statistical interpretations. Setting aside the typical standards for primate work, from a purely statistical perspective the raw numbers involved in this vaccine study are still not large. That means that for any difference in developmental outcomes to reach statistical significance, it would have to be large. And despite the modest sample sizes, the statistical differences reported by the researchers are quite robust. Across a wide range of statistical tests the root reflex finding consistently reached significance with 99% confidence, the suck reflex finding reached significance with 98% confidence and the snout reflex finding reached 95% confidence in two out of three analyses and with 94.5% confidence in the third (95% confidence is the level generally accepted as “statistically significant”).

These findings are clearly sufficient to make the findings important, but it’s worth noting that the authors’ interpretation of their data analysis is highly conservative. In addition to significant findings in three of the nine reflexes, it’s quite plausible to make the case that two more of the reflexes were delayed by HBV exposure as well. The analysis of these reflexes--the auditory startle reflex and the grasp hand reflex--“approached significance” in each case. Two different methodological obstacles contributed to the failure to reach significance.

1. In the case of the auditory startle reflex, the sheer size of the difference between the two groups was larger than any of the three reflexes that showed statistically significant differences. The vaccinated macaques took a full two days longer on average to acquire the auditory startle reflex than the unexposed group; by contrast, the difference between the averages of the two groups’ time to acquire the root reflex was just 1.2 days. The difference in the auditory startle was also understated, since one of the vaccinated macaques never acquired the reflex during the entire two week observation period. Because of the modest sample size, however, the relatively larger variation in this group made the result significant with only 89% confidence.
2. In the case of the grasp hand reflex, a result that was significant with 93.5% confidence, both vaccinated and unexposed macaques acquired this reflex relatively quickly. But since every one of the unexposed macaques acquired the reflex at the first examination, the average time to acquire it was “left-censored”, meaning that it was assigned the minimum possible value of 0.5 days, and almost certainly overestimated the development time of the unexposed sample. If the unexposed group had been measured without any need for “left censoring”, then only a modest reduction (under 10%) in the mean time to acquire the grasp hand reflex would have been enough to bring this result into the significant range.

To make the point more simply, it would have taken only modest differences in the management of the data analysis to make over half of the measured reflexes show significant delays instead of a third of them. Pointing this out is not intended as a criticism of the study, however, but rather a demonstration of how conservative the authors were in their interpretation of the results.

Finally, for the three reflexes that were initially found significant, the authors dug deeper and conducted two different kinds of regression analysis to ensure that the differences were not affected by other factors such as premature birth or low birth weight (the study’s tables provide a painstakingly intricate array of these regression model outputs). The first of these showed a consistently strong developmental benefit of not being vaccinated, with unexposed macaques having a “risk” of developing the three reflexes (where the risk was actually a benefit) that was 3-5 times the “risk” of the vaccinated group (although the snout reflex risk level only reached 94% confidence). The second set of regressions attempted to distinguish whether the effect of vaccination was a main effect or the result of interaction with the effects of premature birth or low birth weight. In all models that compared main and interaction effects, the exposure effect was significant in way or the other: the root and snout reflexes were best explained as main effects (although the root reflect was significant as an interaction effect also), while the suck reflex appeared to be best explained as an exposure risk for low birth weight and/or premature infants.

It’s likely that most readers will skim through the results of these regression models, just confirming the fact that the results were significant. But it’s important to recognize how carefully the analysts have investigated if other factors besides exposure could explain the developmental delays of the vaccinated macaques. In all cases, the delayed development of these reflexes was clearly traced to vaccination.

Potential biases. One likely tactic of critics of the study will include attempts to nullify the evidence based on the alleged bias of those involved. For one, the study is privately funded and acknowledges some well known autism advocates as financial contributors. These include the Johnson family (Jane Johnson is co-author of Changing the Course of Autism, a member of the Board of Directors of Thoughtful House and Director of Defeat Autism Now!), SafeMinds, the Autism Research Institute and Elizabeth Birt. Although all of these groups make clear their research interest is vaccine safety, they are frequently attacked for being “anti-vaccine”, an epithet that will almost certainly be hurled again here.

The most aggressive attacks, however, will likely be reserved for the study authors. The basis of these attacks is best anticipated by the following conflict of interest disclosure in the published paper. “Prior to 2005, [Carol Stott] and [Andrew Wakefield] acted as paid experts in MMR-related litigation on behalf of the plaintiff. [Laura Hewitson] has a child who is a petitioner in the National Vaccine Injury Compensation Program. For this reason, [Hewitson] was not involved in any data collection or statistical analyses to preclude the possibility of a perceived conflict of interest.”

Related evidence on the hepatitis B vaccine

In spite of the active involvement of autism-related organizations and parents in the study’s design and funding, this narrow investigation of HBV exposures doesn’t bear directly on the question of whether HBVs with (or without) thimerosal contribute to causing autism. The only harm described in these vaccinated macaques is in a tightly defined set of “survival reflexes” during a brief window after birth and exposure. We will have to wait for future reports from the research team to gauge both the nature and the persistence of the development delays in the vaccinated group.

At the same time, the narrow focus of the current study invites a similarly focused comparison to a small set of recent studies, published and unpublished, that explored the relationship between HBV/thimerosal exposure and autism or other neuro-developmental delays (NDDs). Three separate studies--two recently reported by a pair of scientists from Stony Brook University, the third disclosed via Freedom of Information Act (FOIA) and performed by researchers from the Centers for Disease Control (CDC)—provided compelling additional evidence linking the birth dose of a thimerosal-containing HBV and elevated autism or NDD risk.

In the fall of 2008, Carolyn Gallagher and Melody Goodman, PhD candidate and Assistant Professor of Preventive Medicine, respectively, at the Stony Brook University Medical Center, reported on their analysis of a sample of over 1800 children whose families were surveyed as part of the National Health and Nutrition Examination Survey (NHANES) in 1999-2000. They took advantage of two questions posed in that survey: 1) “Does your child receive Special Education or Early Intervention Services”; and 2) “Has the survey participant ever received the 3-dose series of the hepatitis B vaccine.” At the time of the survey, all HBVs administered to children under 10 years of age would have contained thimerosal.

When Gallagher and Goodman analyzed the risk of exposure to the 3 dose HBV series in children (the study didn’t query whether this dose included the birth dose, but the CDC’s universal birth dose recommendation was in place during the entire study period), they got back a surprising result. There was no apparent risk of HBV exposure in girls (there even appeared to be a protective effect), but the risk of needing special services in fully vaccinated boys was over twice as high as less vaccinated boys and the difference was statistically significant. When they adjusted the odds for confounding factors, they estimated the increased risk for boys needing special services after full HBV exposure to be fully 8.6 times higher than less vaccinated boys.

Subsequent to this publication, Gallagher and Goodman continued their investigation. Earlier this month, they published an abstract from a poster presentation that reported findings from a more focused investigation. In this analysis they looked at only the birth dose of HBV and boys born before 1999 whose parents reported their child had “received a professional diagnosis of autism.” The more precise data for this work was provided by a different survey, the National Health Information Survey (NHIS) and would again have included only thimerosal-containing HBV. They found that “U.S. male neonates vaccinated with hepatitis B vaccine had a 3-fold greater risk of ASD.”

So from two separate data sources, Gallagher and Goodman have produced findings that dovetail almost perfectly with today’s primate report. In male infants vaccinated at birth with thimerosal-containing HBV, the risk of immediate developmental delays (macaques), the need for early intervention services (NHANES) and autism (NHIS) is increased anywhere from three to eight fold.

If this finding is so clear, the obvious question is why the CDC’s vaccine safety apparatus hasn’t found the same thing.

The answer, of course, is that they have. In their very first examination of the risk of thimerosal exposure in infants, the single most startling finding was this: infants who received the largest exposure of thimerosal in the first month of life showed the highest risk of autism and several other NDDs. Buried deep in a pile of statistical tables that SafeMinds received under FOIA was a risk analysis conducted by CDC analyst Thomas Verstraeten showing statistically significant risk multiples for the most exposed infants. These ranged from 5 times the risk of unexposed infants in the case of sleep disorders to 11.5 times for autism. I summarized these data tables in a report written five years ago. You can find it HERE.

What happened to the CDC findings that are now forcing us to rediscover the risk of thimerosal-containing birth doses of HBV in monkeys? The answer is simple. The CDC team simply censored the data. Infants with the highest levels of thimerosal exposure--those who had received both the HBV and hepatitis B immune globulins--were simply removed from the study sample. In Verstraeten’s words, “the following children were excluded from the analysis…Children that received hepatitis B immunoglobulin as these were more likely to have higher exposure and outcome levels.”

Why they decided this was a legitimate exclusion is anyone’s guess. Unfortunately, it leads us all back to monkeys.

Future research

The report makes clear that future research is both needed and forthcoming. The immediate direction of that research is obvious. There is a clear, indeed urgent, need for further publications that describe what happened to the vaccinated macaques and their unexposed counterparts as succeeding vaccines were administered, including the thimerosal-containing DTaP and Hib vaccines and the MMR vaccine. These publications should include not just how the two macaque groups’ observable development proceeded, but also how their gastrointestinal tracts were affected by the vaccine exposures and how their brain development was changed. Judging from last year’s conference abstracts, the study team’s research program has included both brain imaging and gut tissue analysis, so the main obstacle to further dissemination of the research findings appears to be publication.

Between the May 2008 conference abstracts and today’s publication, over a year has passed and only a small portion of the promised insight from the original abstracts has been made public. The journal editors at Neurotoxicology have taken a courageous stand in publishing what is sure to be unwelcome evidence in some circles. Let’s hope we see more from this project team soon.

Mark Blaxill is Editor-at-Large for Age of Autism and a Director of Safeminds, one of the organizations that sponsored the study.

Abstract: This study examined whether acquisition of neonatal reflexes and sensorimotor skills in newborn rhesus macaques (Macaca mulatta) is influenced by receipt of the single neonatal dose of Hepatitis B (HB) vaccine containing the preservative thimerosal (Th). HB vaccine containing a standardized weight-adjusted Th dose was administered to male macaques within 24 hours of birth (n=13). Unexposed animals received saline placebo (n=4) or no injection (n=3). Infants were raised identically and tested daily for acquisition of 9 survival, motor, and sensorimotor reflexes by a blinded observer. In exposed animals there was a significant delay in the acquisition of three survival reflexes: root, snout and suck, compared with unexposed animals. No neonatal responses were significantly delayed in unexposed animals compared with exposed. Gestational age (GA) and birth weight were not significantly correlated. Cox regression models were used to evaluate the main effects and interactions of exposure with birth weight and GA as independent predictors and time-invariant covariates. Significant main effects remained for exposure on root and suck when controlling for GA and birth weight such that exposed animals were relatively delayed in time-to-criterion. There was a significant effect of GA on visual follow far when controlling for exposure such that increasing GA was associated with shorter time-to-criterion. Interaction models indicated that while there were no main effects of GA or birth weight on root, suck or snout reflexes there were various interactions between exposure, GA, and birth weight such that inclusion of the relevant interaction terms significantly improved model fit. This, in turn, indicated important influences of birth weight and/or GA on the effect of exposure which, in general, operated in a way that lower birth weight and/or lower GA exacerbated the detrimental effect of vaccine exposure. This primate model provides a possible means of assessing adverse neurodevelopmental outcomes from neonatal Th-containing HB vaccine exposure, particularly in infants of lower GA or low birth weight. The mechanism of these effects and therequirements for Th is not known and requires further study.