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Top Federal Autism Panel Votes For Millions in Vaccine Research

Posted: 01/05/09 12:28 PM ET

The Inter-Agency Autism Coordinating Committee (IACC) has voted to recommend earmarking millions of dollars in research funds from the Combating Autism Act of 2006 to study the possible role of vaccines in the causation of autism.

The panel also proposed spending an additional $75 million to study a wide variety of other environmental factors in autism, possibly including parental age, infections, heavy metals, neurotoxins, occupational exposures and "other biological agents."

The decision, made last month, received little or no attention in the media. The vaccine research provisions are now included in the official IACC Draft Strategic Plan for Autism Spectrum Research.

The IACC has 12 members from various health-related branches of the Federal Government, plus six "Public Members," including representatives from Autism Speaks, the Autism Society of America and the Coalition for Safe Minds, as well as Stephen Shore, an adult on the autism spectrum.

Section III of the Strategic Plan is titled, "WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?" The section is divided into various parts, including short- and long-term research objectives. Much of the section is devoted to studying the interactions of genetic susceptibilities with potential environmental triggers, including vaccines.

In fact, two vaccine-autism studies have been approved by the IACC, which has proposed spending $16 million to:

1) "Study the effect of vaccines, vaccine components, and multiple vaccine administration in autism causation and severity through a variety of approaches, including cell and animal studies, and understand whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines by 2011. Proposed costs: $6,000,000


2) Determine the feasibility and design an epidemiological study to determine if the health outcomes, including ASD, among various populations with vaccinated, unvaccinated, and alternatively vaccinated groups by 2011. Proposed costs: $10,000,000

Additionally, under "Research Opportunities," the panel also endorsed this objective:

"Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies."

For proponents of vaccine-autism research, this is a resounding victory. It covers much of what these advocates have been supporting for a number of years. It is also sure to enrage those who are opposed to such research.

But for now, it has been recommended that the US Federal Government spend millions of dollars to study not just thimerosal, (a mercury based vaccine preservative), not just the triple live virus MMR vaccine, but vaccines in general, all ingredients that go into vaccines and, most surprisingly, the effect of "multiple vaccine administration" in the causation of autism.

This document also marks the closest we have come, perhaps, to conducting a study of health outcomes among vaccinated vs. unvaccinated children in the United States. With a price tag of $10 million just to study its feasibility and to design a study, such a project would indeed be costly and cumbersome. But, as CDC Director Dr. Julie Gerberding has said, this is a study that "should and could be done." (There is a bill pending in Congress right now that would provide funding for a vaccinated-unvaccinated study).

But vaccines, of course, are not the only candidates for study in the etiology of autism. There is a growing consensus now that most autism cases arise from an unknown combination of environmental agents, probably interacting with certain genetic predispositions.

The IACC Strategic Plan contains an impressive array of objectives and ideas on studying possible environmental factors. Not surprisingly, there was significant dissention on whether vaccines should still be considered among the list. On this thorny subject, the Strategic Plan says the following:

"Research on environmental risk factors is also underway. An Institute of Medicine workshop held in 2007 summarized what is known and what is needed in this field (Institute of Medicine of the National Academies, 2007). Numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury based preservative, thimerosal (Immunization Safety Review Committee, 2004). These data, as well as subsequent research, indicate that the link between autism and vaccines is unsupported by the research literature. Some do not agree and remain concerned that ASD is linked or caused by vaccination through exposure to Measles Mumps Rubella (MMR), imposing challenges to a weakened immune system, or possibly due to mitochondrial disorder.


Public comment to the Committee reflected opposing views on vaccines as a potential environmental cause. Some contend that cumulative research on this topic indicates no role of vaccines in autism. Others contend that definitive research has not been done. A third view argues that the persistent focus on vaccines and other possible causes is misplaced.

In addition, a number of other environmental agents are being explored through research that are known or suspected to influence early development of the brain and nervous system. Recent studies suggest factors such as parental age, exposure to infections, toxins, and other biological agents may confer environmental risk. These findings require further investigation and testing."

Meanwhile, on the critical subject of interactions between genes and the environment, the panel says this:

"Although most scientists believe that risk factors for ASD are both genetic and environmental, there is considerable debate about whether potential environmental causes, genetic precursors, or interactions between genes and environmental factors should be the highest priority for research aimed at identifying the causes of ASD.

To date, few studies have ruled in or ruled out specific environmental factors. While there are reports of associations of ASD with exposure to medications or toxicants prenatally, and to infections after birth, it is still not known whether any specific factor is necessary or sufficient to cause ASD. Similar to other disease areas, advancing research on the potential role of environmental factors requires resources and the attraction of scientific expertise. Bringing this to bear on autism will help focus the environmental factors to study, as well as the best approach for staging studies to examine environmental factors, interaction between factors, and between individual susceptibility and various environmental factors."

The panel also weighed in on the possibility that "de novo," or spontaneous changes in gene structure - perhaps triggered by environmental factors - may be a factor in the causation of autism:

"(Recent) findings have contributed to new hypotheses about the inheritance of ASD. In families with just one affected member, spontaneous deletions and duplications may be causal factors of ASD. However, what causes these spontaneous deletions and duplications is not clear and possibly could be due to environmental exposures."

It also voted to recommend the following studies of environmental factors in autism, for which it proposed a budget of more than $75 million:

1) "Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene - environment research by 2011."

2) "Initiate studies on at least five environmental factors identified in the recommendations from the 2007 IOM report "Autism and the Environment: Challenges and Opportunities for Research" as potential causes of ASD by 2010."

3) "Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015."

4) "Conduct a multi-site study of the subsequent pregnancies of 1000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014."

5) "Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect nested, case-control data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015.

Some people may object to even this moderate sum of federal research money going into possible environmental factors. After all, the 2007 IOM Report from which the "five environmental factors" to study will be chosen, includes the following suggested areas of inquiry:

Heavy metals and cosmetics


RhoGAM exposure (Rho-D immune-globulin, which contained thimerosal until 2003)

"Major priority" pollutants

Toxins from industrial disasters

Prenatal exposures to infectious diseases

Occupational exposures

People who would object to studying these factors, it should be noted, are a tiny minority and a dying breed.

Far more controversial will be the inclusion of any vaccine wording within the research matrix, even though Members of Congress made it clear in the Colloquy* and Report Language of the Combating Autism Act that vaccines and other environmental factors should be studied. But the dissenting voices are coming through loud and clear in the following proposed (but not yet finalized) passage:

"Those who are convinced by current data that vaccines do not play a causal role in autism argue against using a large proportion of limited autism research funding toward vaccine studies when many other scientific avenues remain to be explored. At the same time, those who believe that prior studies of the possible role of vaccines in ASD have been insufficient argue that investigation of a possible vaccine/ASD link should be a high priority for research (e.g., a large-scale study comparing vaccinated and unvaccinated groups). A third view urges shifting focus away from vaccines and onto much-needed attention toward the development of effective treatments, services and supports for those with ASD."

Of course, it remains to be seen if these vaccine studies survive into the final version of the IACC Strategic Plan. And even if they do, that does not guarantee they will be fully implemented.

But one thing seems pretty clear, as we head into the last year of the century's first decade: Much to the chagrin of many, the vaccine-autism debate is anything but over.

*NOTE: In the Senate Colloquy, Sen. Mike Enzi, who was Chairman of the Committee (H.E.L.P.) that developed the bill, said this: "I want to be clear that, for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder. Thus, I hope that the National Institutes of Health will consider broad research avenues into this critical area. No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know.

Meanwhile, Co-Sponsors Santorum and Kennedy agreed with Enzi's statement, and Senator Chris Dodd added this: Through the Combating Autism Act, all biomedical research opportunities on ASD can be pursued, and they include environmental research examining potential links between vaccines, vaccine components and ASD."

 
 
 
 
 
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12:00 PM on 01/07/2009
What I would really love to see is a vaccinated vs. unvaccinated study where the participants all have ASD. I have two unvaccinated children, one who has ASD, the other who has chronic health issues. I definitely believe that there is a strong connection between vaccinations and autism. In fact, that is one reason why we chose not to vaccinate in the first place. I did not have amalgams, and I did not have Rhogam during pregnancy. However, my kids still have heavy metal overload. This kind of study should help to find more explanations for contributing environmental factors. I know my kids are not the only kids out there who have not been vaccinated and don't fit the description for some other known environmental factors. I would love to have some answers.
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AutismNewsBeat
10:36 PM on 01/07/2009
How do you know your children have "metal metal overload"? What kinds of metals? How are they being tested?
03:37 PM on 01/08/2009
I have done several lab tests with our DAN! (Defeat Autism Now!) doctor. We have tested heavy metal toxicity/excretion in the hair, urine and feces as well as urine porphyrin tests which measure biomarkers for heavy metal toxicity. Both of my kids have shown toxic levels of mercury, lead, aluminum and arsenic.
04:04 PM on 01/08/2009
I also personally know several totally unvaccinated kids. A large number of homeschooled kids as well as homebirth/babies born using a midwife often go completely unvaccinated. Parents who choose this option often go to natural health practitioners who agree with parents' choice for vaccinations.

Also, many parents are afraid to disclose their "choice" to not vaccinate their kids for fear of government agencies who have been known to accuse parents of medical neglect for this reason.

There are many, many children now who are totally unvaccinated, particularly siblings of kids with autism. These parents have seen their typically developing child regress within hours-days of receiving their shots. Kids who were completely verbal losing all language, etc. etc. And I wonder why they would not want their other children vaccinated!
10:59 AM on 01/07/2009
Results and rhetoric in the proposed studies can be skewed as the CDC, pharma, and the IOM decree in advance. The principle investigator and the methods of such studies will be crucial. Citizen-watchdog groups will be needed to ensure valid studies.
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03:13 PM on 01/06/2009
Thank you for all your efforts to protect our children. It helps keep me from falling to complete and dark cynicism. I’m constantly seeing children less healthy in their immune function and development (generally just less healthy) than I saw in my generation (and probably my parents’ and grandparents'). The precautionary principle was steamrollered in the nineties when it came to exposing infants to industrial products. Now they MIGHT do the type of research I irresponsibly assumed our “health” agencies were doing all along. It won’t restore my daughter’s health,

but part of my daughter’s life (and mine) has been restored by individuals like yourself.

Thank you!
11:47 AM on 01/06/2009
Thanks, David.

The footdragging on the government's part to do this research is so obvious. They already know vaccines cause autism. The autism epidemic has been going on for 20 years and they are now contemplating doing the research. How pathetic. Apparently, they are not smart enough to figure out the autism is going to break the bank of this country. And let's not forget about the international ramifications that David eluded to in his book. We've poisoned our own and then the world. We should all be scared.
11:25 PM on 01/05/2009
Thanks for your continued work and analysis on this subject, David! I don't quite understand how this group could collectively support looking at various environmental triggers and exposures, yet still have a few dissenters when it comes to taking a hard look at vaccines. After all, vaccines are comprised of "infectious disease" viruses and are laced with "major priority pollutants" and "toxins" (aluminum, formaldehyde, mercury, etc.). Even if my cosmetics were laced with these things, how on earth could the uptake and transmission (through my skin, endocrine system and placenta) possibly compare to directly injecting it into the bloodstream of a developing infant? Basic chemistry and published intake/exposure data would tell you that it wouldn't. Yes, all of these things may contribute, but let's look at the most likely (and direct) path of exposure first!
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AutismNewsBeat
10:38 PM on 01/07/2009
Formaldehyde is a natural bi-product of single carbon metabolism. Our bodies make it all the time.
11:21 PM on 01/05/2009
Thank you David for posting this information and continuing your work on this story. This report is a great step forward for finding answers to help an ever growing population of kids who need us.
10:59 PM on 01/05/2009
"People who would object to studying these factors, it should be noted, are a tiny minority and a dying breed."

That is a beautiful thing and real research aimed at ending this epidemic and hopefully helping to heal our kids is wonderful!! Unfortunate that it has taken this many years and countless more children to be injured to finally shut up those who have a) denied due to ignorance, b) denied due to conflict of interest, c) denied due to fear of change, or d) denied due to a perfect storm of all of those factors plus an increasing amount of narcissistic ego.

In light of all of the scientific evidence of harm, to deny anymore would most certainly be a red flag to one's motivation. People like Dr. Paul Offit may have to explain medically and logically how he could betray parents and innocent children by denying that vaccines can cause injuries--autism. Time will tell what letter, a--d , he receives for his actions and inactions.
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LaurieAnn
Charity is NOT a substitute for justice.
09:36 PM on 01/05/2009
My 11 year old has autism and I'm fine with the study going forward, but what I would really like to see is millions and millions of $$ provided for the education/job training/housing needs of children and adults on the autism spectrum. There is also no federal enforcement of IDEA legislation; this lack allows our public school system to run ripshod over parents unless they can spend their money to hire attorneys to fight for their kid's education. Autism prevention is necessary, but what about the thousand of autistic children and adults who are needing help now!
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CraigWilloughby
In the immortal words of Socrates, "I drank what?"
06:04 PM on 01/06/2009
Amen!
06:34 PM on 01/06/2009
Yes, I agree totally! The lack of funding and lack of quality in the special education in this country has been repulsive! It is part of the reason I am trying to home school my son.
We continue to hear time and time again about teachers, like my sons former teacher, who are allowed and even condoned to abuse our kids! Those teachers should not be teaching and some should be behind bars!
09:14 PM on 01/05/2009
I'll be amazed if it actually gets passed or voted upon in the affirmative. Autism Speaks has repeatedly tried to thwart any efforts at funding this type of research. In fact, if you want to know the extent of the methods that they utilize to thwart those efforts, I suggest you read the recent rant from Katie Wright on Age of Autism called Enough's Enough.

With Autism Speaks involved, I'm not believing any of it until it actually happens.
06:30 PM on 01/05/2009
I have to assume that you weren't listening in on the December 12 IACC meeting. Otherwise, you would know that the Strategic Plan has not been finalized or voted upon. You are misleading people, Mr. Kirby.
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David Kirby
10:40 AM on 01/06/2009
Members of the committee DID vote on whether or not to include the vaccine research provisions at the December meeting. I have the current draft of the SP, and it includes all of the vaccine language with the footnote that it was "accepted" at the December meeting.

Next week, the panel will meet to discuss bugetary matters on each of these research items, but for now, the vaccine provisions have been voted into the Draft SP. That doenst mean they will survive in the final version, though I think it would be hard at this point to "unvote" the recommendations.

Even so, I do call this a DRAFT plan throughout my piece, and this is what else I said - I am not sure why this is misleading:

"Of course, it remains to be seen if these vaccine studies survive into the final version of the IACC trategic Plan. And even if they do, that does not guarantee they will be fully implemented."

Best,

DK
t
01:49 PM on 01/07/2009
David: I am a graduate student at MIT studying cellular aspects of autism and fragile X syndrome. I'd like to get a copy of the draft of the IACC Strategic Plan to read myself. Has it been made public? Can you email it to me at BDolan@MIT.edu?
Thanks,
Bridget
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CraigWilloughby
In the immortal words of Socrates, "I drank what?"
06:02 PM on 01/06/2009
Well, I was going to respond to ThugJ's comment, but I think that David did a far better job of addressing his "concerns."

Of course, if he had actually read the article, he would have seen what Mr. Kirby was talking about.
06:38 PM on 01/06/2009
Exactly!
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06:27 PM on 01/05/2009
Hopefully, someone take a close look at the possibility that Tylenol is what's behind the spike in autism. After aspirin's link to Reye's Syndrome was discovered in the late 80's and early 90's, parents were instructed to use Tylenol instead. It is common practice for pediatricians to tell parents to give babies Tylenol before and after vaccines to ward off fever and irritability. However, doing so will deplete glutathione when their little bodies need it the most-to filter out the toxins in the vaccines! I don't believe that it's a coincidence that at the same time Tylenol use started becoming more widespread, autism cases increased as well.
05:43 PM on 01/05/2009
Let's hope that this research money goes to studies to prove that vaccines DO cause autism, rather than follow most previous government studies which always seem to try to prove that vaccines DON'T cause autism.
I have always wondered how someone can prove a negative.
11:14 PM on 01/05/2009
I often wondered this myself....
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AutismNewsBeat
05:10 PM on 01/06/2009
Researchers test the null hypothesis precisely because one cannot prove a negative. That's why study after study concludes "data does not support an association between vaccines and autism".
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CraigWilloughby
In the immortal words of Socrates, "I drank what?"
06:00 PM on 01/06/2009
A very polite response. Thank you
10:25 AM on 01/07/2009
Actually what researchers are trying to do is to reject the null hypothesis. The null hypothesis is that there is no difference, for example, between two groups of people. Typically you start with an hypothesis (factor X affects some number of people); the null hypothesis is that it does not; the purpose of such studies is normally to prove that the effect exists. A failure to reject the null hypothesis means that no difference was found; which is why the studies ANB refers to state the conclusion as he indicated above.

Typically studies that fail to reject the null hypothesis don't get published -- because they didn't find any differences. The following letter from Dr. Jon Poling (regarding an unrelated issue, but he goes into details about the scientific method):

http://pediatrics.aappublications.org/cgi/eletters/123/1/e164#39891
03:17 PM on 01/05/2009
I have two unvaxed kids and know hundreds of others if they need subjects for an unvaxed/vaxed study .. :)
11:19 PM on 01/05/2009
Besides your family there are many families who do not vaccinate such as: Christian Scientists, several Amish communities, holistic health care providers (such as http://www.homefirst.com/ with 15,000 babies delivered in home births and most are not vaccinated.)

I am sure a study could be done based on subsets of the population out there that choose not to vaccinate.
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AutismNewsBeat
10:44 PM on 01/07/2009
Which Amish community are you talking about?
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AutismNewsBeat
05:12 PM on 01/06/2009
There are not enough unvaxed children in the US to conduct the study that you and others propose, if you want results that even approach 95% certainty.

http://photoninthedarkness.com/?p=154
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CraigWilloughby
In the immortal words of Socrates, "I drank what?"
06:08 PM on 01/06/2009
Very good point. However, I think that if the study were to actually happen, there would be a reasonable number of unvaccinated children that we could study. I'm very interested in seeing the proposal for the study when it comes out to see how they would do it.
10:28 AM on 01/07/2009
So how is that there are studies that allegedly exonerate vaccines? If there aren't enough unvaccinated children to do this study (a point I do NOT concede) then how can any of the existing studies prove (which they don't anyway) that vaccines don't cause autism?
03:08 PM on 01/05/2009
Aside from this wonderful news, albeit news that's a few years late and a few years more until this study will mean anything that causes action, this is a refreshingly well-written objective piece of journalism. Bravo author!
02:52 PM on 01/05/2009
I hope this is a step in the right direction and not ultimately a big pharma money maker! As much as I would love to be hopeful and excited about this big study, is as much as I have been let down by more scientists and doctors and pharma co.'s getting richer and richer and sweeping the truth under the carpet.
I am also concerned about this being a big scale research study. Where are they going to find so many unvax'd children? The way I understand it, most Amish do not participate in our modern studies. With the political pressure along with the education boards, there must be very few unvax'd kids elsewhere.
Just some questions that come to mind about this.
If this does happen, I would like to thank CDC Director Dr. Julie Gerberding in advance for any participation or contribution she may have.
As always, THANK YOU David for bringing this to my attention.
Take care.