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David Kirby: US Health Officials Back Study Idea on Vaccinated vs. Unvaccinated Children – Will Media Take Note?

Do it now By David Kirby

It is not accurate for members of the media to report that the link between vaccines has been “disproven.” This is especially true in light of recent news from the National Vaccine Advisory Committee, and a series of news items from the Federal Court of Claims, Federal health agencies, leading universities and top autism researchers around the country. There are now many reasons why the media should continue its coverage of this serious and ongoing debate:

THE NATIONAL VACCINE ADVISORY COMMITTEE (NVAC)

On Friday, February 27, a special group convened by The Keystone Center on behalf of the Department of Health and Human Services’ National Vaccine Advisory Committee Vaccine Safety Working Group (NVAC VSWG) recommended appointing a panel of experts to explore the strengths and weaknesses of conducting studies on health outcomes in vaccinated vs. unvaccinated populations. The group, known as the “Salt Lake City Writing Group,” said it was “desirable” to include autism as one such health outcome.

As they stated in a draft “consensus statement”:

“(There is) a strong desire to study the health impact of the immunization schedule, potentially through a ‘vaccinated vs. unvaccinated study’. Outcomes to assess include biomarkers of immunity and metabolism, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and learning disabilities. The inclusion of autism as an outcome is desired”

The Writing Group supported a recommendation to “charge an expert panel with evaluating study designs for research on the impact of the standard schedule of vaccination on an array of health outcomes of significant public interest. This draft charge is responsive to issues raised at community meetings in Alabama, Oregon, and Indiana as well as the Interagency Autism Coordinating Committee request for collaboration with the National Vaccine Program Office.”

Writing Group members who drafted the statement included Federal and State health officials, Federal vaccine officials, CDC officials, and leaders of autism and vaccine safety advocacy groups. They included the following individuals:

Federal Health Agencies and Panels

CDC:

Roger Bernier, Ph.D., MPH, Senior Advisor, CDC
Elizabeth Skillen, PhD, MS, Policy Analyst, Immunization Safety Office, CDC

HHS:

Bruce Gellin, M.D., MPH, Director, HHS National Vaccine Program Office (NVPO) and Executive Secretary of NVAC

Dan Salmon, Ph.D., Vaccine Safety Specialist, HHS - NVPO

Ben Schwartz, M.D., former Associate Director for Science, HHS and Medical Director for CARE

NVAC:

Guthrie Birkhead, M.D., MPH Chair, HHS National Vaccine Advisory Committee (NVAC)  and member of NVAC Vaccine Safety Working Group, also Deputy Commissioner, Office of Public Health, NY State Dept. of Health

Andrew Pavia, M.D., NVAC Member & Chair, NVAC Vaccine Safety Working Group and with Dept. of Pediatrics, Utah School of Medicine

Chris Carlson, Ph.D., NVAC Vaccine Safety Working Group Member, and with Fred Hutchison Cancer Research Center, Seattle

Lance Gordon, Ph.D., NVAC and member of NVAC Vaccine Safety Working Group

James Mason, M.D., DrPH, NVAC Member and member of NVAC Vaccine Safety Working Group, former CDC Director and former Assistant Secretary of Health

Tawny Buck, member of NVAC Vaccine Safety Working Group, parent of DPT brain injured daughter

State & Local Public Health Agencies and Organizations

Anna Buchannan, MPH, Senior Director, Immunization & Infectious Disease, Association of State and Territorial Health Officials (ASTHO)

Jim Shames, M.D., Medical Director, Jackson County Health Department, OR

David Sundwall, M.D., Executive Director, Utah Department of Health

Collette Young; Ph.D., MS, Surveillance & Training Manager, Oregon Public Health Division, Immunization Program,  OR Public Health Division

Robert Bednarczyk, NVAC Research Analyst, NY Department of Health 
 
University/Academic

Joseph A. Bocchini, Jr., M.D., Professor & Chairman, Department of Pediatrics, Louisiana State University

Margaret Dunkle, Senior Fellow, Center for Health Policy Research, George Washington University and Director, Early Identification and Intervention Collaborative, LA County

Alan Greene, M.D., Clinical Profession, Division of General Pediatrics, Packard Children's Hospital, Stanford University School of Medicine;

Heather Zwickey, Ph.D., Dean of Research and Associate Professor of Immunology, National College of Natural Medicine, Oregon

Autism or Vaccine Organizations

Peter Bell, Executive Vice President, Programs and Services, Autism Speaks

Sallie Bernard, Executive Director, Safe Minds

Vicky Debold, PhD, RN, Director of Patient Safety, National Vaccine Information Center;
Barbara Loe Fisher, Co-founder & President, National Vaccine Information Center
 
Members of Public or Other Child Health Groups
 
Tracy Cron, RN and mother who attended the Birmingham public engagement workshop
Dennis Johnson, MS, Executive VP, Policy & Advocacy, Children's Health Fund, NYC
Debbie McCune Davis, Program Director, Arizona Partnership for Immunization, Arizona State Senator

(*PLEASE SEE THE DRAFT CONSENSUS STATEMENT BELOW)

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Meanwhile, there have been many news stories related to this issue coming out of the Federal Court of Claims, Federal agencies, and leading research centers. Many of these stories have not been reported in the media. They include:
 
FEDERAL COURT CASES:

Bailey Banks vs HHS - February 2009 – Special Master Abell found that the measles-mumps-rubella (MMR) vaccine caused brain damage in this child, which led to his diagnosis of Pervasive Development Disorder Not Otherwise Specified (PDD-NOS) an autism spectrum disorder. Bailey will likely receive over $3 million in compensation to cover a lifetime of autism care and treatment.

Hannah Poling vs HHS – February 2008 – Medical personnel at the Health Resources and Services Administration conceded that this girl’s autism (and epilepsy) was caused by “vaccine induced fever and immune stimulation that exceeded metabolic reserves.” Hannah had a mild case of mitochondrial dysfunction, and received nine vaccines in one day at age 19 months. She now has full blown autism and a very serious seizure disorder.

FEDERAL AGENCIES:

US Department of Health and Human Services (HHS) & US Environmental Protection Agency (EPA) – January 2009 - These two agencies have just launched the National Children's Study (NCS), which is now recruiting 100,000 children, among which researchers expect to find 600 to 700 with an ASD by age three. Federal officials will compare these ASD children to controls, to see what impact that vaccines (combined with genetic factors) had on the development of their illness.

US Department of Health and Human Services (HHS) Inter-Agency Autism Coordinating Committee (IACC) & National Vaccine Program Office (NVAC)January 2009 – These two Federal health groups announced their deisre to collaborate on research designs and methods for investigating the potential links between vaccines and autism, including the feasability of doing a large study of vaccinted vs. unvaccinated children. The move by these officils grew out the process set forth by the Combatting Autism Act of 2006, whose authors, Senators Kennedy, Dodd and Enzi stated that vaccines should be included in research of the causes of autism.

US Centers for Disease Control and Prevention (CDC) CADDRE Network – November 2008 – The CDC is conducting and planning several vaccine-autism investigations. One such effort is The National CADDRE Study. This 5-year project of the CDC's Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network will "identify what might put children at risk for autism," says the CDC, which will study "specific mercury exposures, including any vaccine use by the mother during pregnancy and the child's vaccine exposures after birth."

US Centers for Disease Control and Prevention (CDC) Clinical Immunization Safety Assessment (CISA) Network April 2008 - The CDC’s CISA Network includes leading autism researchers and America's health insurance companies. Last April, CISA and the CDC announced support for studying, “Immunization associated with increased risk for neurological deterioration in children with mitochondrial dysfunction." And the CDC also announced that, "CISA has formed a working group to study methods related to mitochondrial disorders and immunization.”

US Centers for Disease Control and Prevention (CDC) Immunization Safety Office – April 2008 - As part of its draft research agenda for vaccine safety, the CDC added a section on studying severe chronic conditions potentially linked to childhood vaccines, including "Autoimmune diseases; central nervous system demyelinating disorders; encephalitis/ encephalopathy; and neurodevelopmental disorders including autism."

National Institute of Childhood Health and Human Development (NICHD) – February 2009 – Dr. Duane Alexander, Director of the NICHD –an agency of the NIH – recently stated that, “Genetic variations exist that cause adverse reactions to specific foods, medications, or anesthetic agents -- it is legitimate to ask whether a similar situation may exist for vaccines.” Why? Because there may exist, “subpopulations unable to remove mercury from the body as fast as others, or some adverse or cross-reacting response to a vaccine component, or a mitochondrial disorder increasing the adverse response to vaccine-associated fever.”

National Institute of Allergy and Infectious Diseases (NIAID) – December 2008 – Dr. Anthony Fauci, Director of this NIH agency, told US News & World Report: "If we can show that individuals of a certain genetic profile have a greater propensity for developing adverse events, we may want to screen everyone prior to vaccination (for) undetectable diseases like a subclinical mitochrondrial disorder."

LEADING U.S. CENTERS OF RESEARCH:

Johns Hopkins Medical Institutions - The Kennedy Krieger Institute - January 2009 The nation's premiere autism research outfit is sponsor of the Interactive Autism Network (IAN). Its new questionnaire deals with autism and vaccines. Thousands of families are describing their experiences with autistic regression following vaccination. Top scientists will then use this information, "to conduct additional vaccine-focused studies."

Cleveland Clinic, Harvard University, Johns Hopkins University – November 2008 Some of the nation’s leading experts in autism and/or mitochondrial disorders published a study showing that children with mitochondrial disorders are at greater risk for autistic regression. They found that vaccine reactions could possibly trigger autistic regression in kids with mito disorders, adding that, "There might be no difference between the inflammatory or catabolic stress of vaccinations and that of common childhood diseases.” And these very mainstream scientists wrote that: "Large, population-based studies will be needed to identify a possible relationship of vaccination with autistic regression in persons with mitochondrial cytopathies."

University of California, Irvine - Center for Molecular and Mitochondrial Medicine in Genetics – April 2008 - Children with mitochondrial disorders are not only at greater risk for autistic regression, but they are also more likely to suffer from vaccine injuries, Dr. Douglas Wallace, Professor of Molecular Medicine and Director of the Center for Molecular and Mitochondrial Medicine in Genetics at UC Irvine, testified at the National Vaccine Advisory Committe. A member of the United Mitochondrial Disease Foundation’s scientific board, and father of a son with autism, he stated, "We advocate spreading vaccines out as much as possible. Each time you vaccinate, you're creating a challenge for the system, and if a child has an impaired system, that could in fact trigger further clinical problems."

University of California, San Diego - 2008 – Researchers from this school published a preliminary study in the journal Autism stating that children given Tylenol after the MMR vaccine were several times more likely to develop autism. Tylenol can reduce levels of glutathione - a powerful antioxidant and detoxifier. "Tylenol and MMR was significantly associated with autistic disorder," the authors wrote. "More research needs to be completed to confirm the results of this preliminary study."

University of California, Davis – M.I.N.D. Institute – January 2009 – The authors of this new study say that genetics alone cannot explain the ASD rise in California. "We're looking at the possible effects of metals, pesticides and infectious agents on neurodevelopment," said Dr. Irva Hertz-Picciotto, a professor at UC Davis. She had also noted that epidemiological studies done by CDC and in Denmark, showing no evidenmce of a vaccine-autism link, were seriously flawed. Meanwhile, Dr. Isaac Pessah, Chair of Molecular Biosciences and Director of UC Davis’s Center for Children’s Environmental Health, is also a member of the ASD Strategic Planning Workgroup at the Inter-Agency Autism Committee, where he supports vaccine research into the causes of autism.

The United Mitochondrial Disease Foundation – August 2008 - Mitochondrial disorders are probably not rare in the general population. They were thought to affect just 1-in-5,000 people. But new research suggests that genetic mutations that might confer mitochondrial dysfunction might be found in 1-in-400 to 1-in-50. Another  study by the United Mitochondrial Disease Foundation (UMDF) found mitochondrial DNA mutations that might cause disease in up to 1-in-200 people.

Autism Speaks – 2008 - The world’s largest, most respected and most mainstream autism foundation firmly supports and funds reserarch into possible connections between vaccines and ASD. Autism Speaks recently authorized three studies on thimerosal, vaccines and autism, and the foundation is in the process of funding many more highly significant research projects on the issue.

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DRAFT CONSENSUS STATEMENT OF THE NVAC WORKING GROUP:

(SOURCE: The Keystone Center)

Based in part on data from the community meetings in AL, OR, and IN as well as the IACC request for collaboration with the National Vaccine Program Office the writing group drafted a consensus recommendation to be considered by stakeholders at the March 16th meeting of the NVAC Safety Working Group.  This recommended charge is for an expert panel to evaluate study designs for research on the impact of the standard schedule of vaccination on an array of health outcomes of significant public interest. 

Draft Consensus Recommendation from the Writing Group:

Public and stakeholder engagement activities have identified a strong desire to study the health impact of the immunization schedule, potentially through a “vaccinated vs. unvaccinated study”.  Additionally, the IACC has requested the NVAC consider the feasibility of such a study. This idea raises a number of methodological, technical and other issues. 

The draft ISO scientific agenda includes several elements of this question, including simultaneous vaccination (e.g. the vaccine schedule) as well as specific outcomes that have been discussed regarding the vaccine schedule and simultaneous vaccination.  Well designed studies in this area would add substantially to our knowledge. 

Given public and stakeholder interest in this topic, we recommend an external expert advisory group with broad expertise assess this issue.  This expert panel should be convened under the auspices of a well-respected independent body.  Particularly:

• 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 metabolism, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and learning disabilities.

• The inclusion of autism as an outcome is desired.  This review should also consider what impact the inclusion of 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.

• Specific attention should be paid to the potential roles or synergies with National Children’s Study. 

David Kirby is author of Evidence of Harm, a founding contributor to Huffington Post and a contributor to Age of Autism.  His next book, “ANIMAL FACTORY” – about the impact of industrial livestock production on our health and the environment – will be released within the year.

Comments

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joy

Did i miss something? shouldn't they also be studying the TIMING of the vaccination program regarding outcomes? The kids I know diagnosed on the autistic spectrum all experienced some neonatal distress, but received the vaccinations on the usual timetable. That is where I have seen the problems, including in my own son. Why insist on the same timetable for a neurologically vulnerable infant? No, I'm not a doctor, and I'm not a researcher, but I'm a parent who would advise any parent to hold off on vaccines (you make the decision, not the pediatrician. You have the ultimate responsibility for your child) until a later date, not only if your child is ill that day, but also if your child had any birth distress, was in the NICU or back in the hospital for anything in his or her first month of life. That's one Mom's take.

MinorityView

Study looking at one group of partially vaxed children in Europe found something interesting:
http://pediatrics.aappublications.org/cgi/content/abstract/123/3/771

Janet Keith

I hate to say it but I have totally lost faith in our government agencies to conduct any study. The CDC and FDA are pawns of the multi-billion dollar vaccine industry. Sadly what began as a concern for the health of our children has become a cold, money-making industry. If the CDD, FDA, NIH, AAP were so concerned about our children's health, they would have long ago investigated the thousands of children injured by the vaccines - especially the SIDS cases. Japan has decreased their rates of SIDS by delaying vaccines. The only reason government is finally responding is that the number of parents and families affected have become so large that the outrage cannot be silenced - no matter how much they say "there is absolutely no link to the vaccines." We know better, and we don't want to see any more children damaged or killed...we are living with the pain every day.

John Stone

Kathy,

I don't necessariy dispute that - though I don't know enough about it - but I am not sure why it would stop detecting a significant effect for vaccines independently.

John

Kathy Blanco

John, what has changed is the timing of the cord clamping in children being born...from four minutes to thirty seconds...this is an ACOG policy. I cannot believe that just vaccines is tipping this scale. I think the combination effect is possibly the reason why, too much oxidative stress, and whala....

Melinda Kohn

Can't we just raise enough money to study this one medical practice in the link below? Their clients also don't get asthma. That should get us lots of press!

http://www.infowars.com/articles/science/autism_none_for_unvaccinated_amish.htm


"But thousands of children cared for by Homefirst Health Services in metropolitan Chicago have at least two things in common with thousands of Amish children in rural Lancaster: They have never been vaccinated. And they don't have autism.

"We have a fairly large practice. We have about 30,000 or 35,000 children that we've taken care of over the years, and I don't think we have a single case of autism in children delivered by us who never received vaccines," said Dr. Mayer Eisenstein, Homefirst's medical director who founded the practice in 1973. Homefirst doctors have delivered more than 15,000 babies at home, and thousands of them have never been vaccinated."

John Stone

Kathy,

I don't think you are wrong but nevertheless the one thing which stands out which we do differently since mid-80s is that we vaccinate much more. Foetuses and infants may have to withstand a host of environmental insults - probably always did - but something has tipped the balance.

One thing that makes me feel relatively optimistic about this initiative is that it does read like they are concerned, rather than simply trying to get off the hook. It acknowledges that issues are exactly where Bernardine Healy said they were last May.

Here we go again...

“(There is) a strong desire to study the health impact of the immunization schedule, potentially through a ‘vaccinated vs. unvaccinated study’. Outcomes to assess include biomarkers of immunity and metabolism, and outcomes including but not limited to neurodevelopmental outcomes, allergies, asthma, immune-mediated diseases, and learning disabilities. The inclusion of autism as an outcome is desired”

What exactly does "the inclusion of autism as an outcome is desired" mean? I don't quite understand this. That it would be desirable if autism were somewhere in there but it would be okay if it weren't?

Sorry, don't trust these people, its like the SEC *investigating* Madoff all over again (don't quite see anything here).

Kathy Blanco

Suzanne
I am with you babe...NIH or CDC involvement will be a mockery to science in this regard. We have to fund this ourselves, and share the outcome with the world.

However, I am concerned that autism could be caused/initiated, conjoined by other factors other than vaccines, so the "lasagna layers" of autism may not be reflected in this study. For instance, I truly feel some initial damage is done in utero by infections/metabolic/toxic problems or thyroid insufficiency in mothers, which may damage or have a delay like fashion to them and or be triggered by vaccines. Even the birthing methods that are so "Safe" today are not. I only wish there was a proper way to go about this in such a fashion that the legitimacy of these concerns are ALSO spelled out. Of course, all of these not only implicate pharma, but they implicate our food industry, our ACOG birthing methods, our dental associations, our toxic fluoride waste water people, and so on and so forth. So basically, not only are we fighting the big boys of industry in pharma, but all the industrial medical complexes. Good luck with that...

But we have to do something to prove this to the world, how many parents and children is it going to take until someone gets concerned?

Kelli Ann Davis

"This review should be conducted expeditiously, in a transparent manner, and involving broad public and stakeholder input."

Teresa and Keith, I share your concerns.

Considering the fact that GR: 1) is probably one of the most vocal autism organizations out there, 2) we represent the voices of tens of thousands of parents, 3) we’ve been involved in and initiated meetings in DC for years (IOM Environmental Workshop for instance), 4) we are in the process of funding our own scientific research, and 5) Stan Kurtz developed a Methyl-B12 nasal spray (he obviously understands the science) we were NOT ALLOWED to participate in this meeting (“not enough room” was one excuse I was given and yet they managed to find a spot for a single RN from the Birmingham public meeting).

Seems to me if they were genuinely interested in putting all of this to rest, GR would be one of the first groups they’d be inviting to the table -- at least that’s what I’d do. Instead, they “fought” me at every turn as I pushed like hell to get us directly involved in crafting this document.

That, coupled with the recent IACC “reversal vote” (after almost 2 years of “sitting down at the table” crafting the SP), the 3 Vaccine Court “verdicts”, and the black-out on the Banks concession makes me very leery of their motives.

As such, GR will not be attending the “second part” of this “stakeholder meeting” on March 16 and I’ve conveyed this to Keystone and to several NVPO officials earlier this week:

“I have no intention of putting our name to a process where we have been deliberately ignored and delegated to the side -- a position of your choosing, not ours.”

Bottom Line: It will be interesting to see what the CDC does with these “suggestions” once the document lands in their lap; whether they “officially” become a part of the scientific agenda remains to be seen. In the meantime, given their “track record” and all the recent events, I’m going to focus my energies elsewhere.

Suzanne

As long as the CDC and NIH have anything to do with this study I have a hard time believing this study will be designed to reveal any truth. They will just do the study, say they found nothing, and lock away the data so noone can see it like they often do.

Think about it, if parents funded it, no matter how good the study design, it would be dismissed as "biased" because of who funded it. So, why is a study that is done by the CDC, the agency both responsible for vaccine safety AND recommending vaccine policy--the govt. agency with the most to lose if it were shown that vaccines injure many kids-not considered biased?

This study needs to be independent of the CDC and researchers connected to the vaccine industry. Period.

Teresa Conrick

Whoops- missed answering your question, "Will Media Take Note?"...

Let's hope they do. The evidence is really coming out showing the exact biological mechanisms that can happen to cause an autism diagnosis and for any paper to report on only one side (often their medical/pharmaceutical sponsors' side)has just got to be wrong --both legally and ethically.

And, how the hell can much of the media continue to spit out Offit sound bites knowing that he has deep conflicts of interest and what appears to be a deficit in ethics or morals?

This from a newspaper today--and the good doctor sounds like she had the Offit pod put under her bed.....my analogy
http://en.wikipedia.org/wiki/Invasion_of_the_Body_Snatchers

The Vaccine Dilemma: Many families, some fearing autism risk
http://www.post-gazette.com/pg/09060/952435-114.stm

"First, she said, children's immune systems are exposed to far more challenges from daily living than they are from all the vaccinations combined." (Wow--do you think this is the "infants can be exposed to 100,000 vaccines or more", made up propaganda piece by Offit, and now being regurgitated into a more palatable, yet still bullshit sentence?)

"Second, even though children get far more vaccinations today than they did 40 years ago, they are exposed to far fewer substances in those vaccines that trigger an immune reaction."
(how clever she was to substitute "substances" instead of "antigens" so we wouldn't see she plagiarized this from Paul Offit, antigen extraordinaire.)

Jeff Ransom

Can someone smarter then me (like Dan, David, Mark, Kim, or JB) tell me what this means.

Does this mean we will get meaningful research, might get meaningful research or still a long shot.

skeptical

This "special group" very well knows that if the goverenment doesn't conduct this study then an autism org. will, and this special group will not like the outcome of the study.

This way the government can design the study with a predetermined outcome.

Same song, different verse.

RimlandFanWA

Studies like this are only good if independant researchers have equal access to the data. A repeat of the shenannigans that happened leading up to Simpsonwood would be a bad thing. Thanks for keeping on it David!

Keith

I trust these guys to be unbiased about as far as a 3 year old could throw them.

What will be done to take the people that recommend/make the vaccines out of the study design equation?

I may be cynical but it could just be another study designed to back a specific outcome.

Teresa Conrick

All right! And keeping with the theme here on AoA the past few days--it is f***ing time!
(can I actually post that?)

But, there will be those who don't want this study done and I am concerned for its safety and longevity and since these are the kind of folks who do not care about safety or health outcomes....can we trust that this will happen in a legitimate manner?

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