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US Health Officials Back Study Idea on Vaccinated vs. Unvaccinated Children - Will Media Take Note?

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It is not accurate for members of the media to report that the link between vaccines and autism has been "disproven." This is especially true in light of recent news from the National Vaccine Advisory Committee - and a series of other 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 (NVPO) - January 2009 - These two Federal health groups announced their desire to collaborate on research designs and methods for investigating the potential links between vaccines and autism, including the feasibility of doing a large study of vaccinated vs. vaccinated children. The move by these officials grew out the process set forth by the Combating 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," after learning that mitochondrial disorders are not uncommon in ASD cases. 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 he supports autism-vaccine research, saying 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 be, "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 evidence 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 research 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.

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.