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 and tapes 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.

CHICAGO -- In the arms race between humans and bacteria, the ability to form "biofilms" -- large aggregations of microbes embedded in a slimy matrix -- has been one of the weapons the organisms use to defeat the immune system, antibiotic drugs and other threats. But scientists, who only recently recognized the role that biofilms play in antibiotic resistance, may be closing in on promising prospects for defeating pathogens.

Scientists have learned that bacteria that are vulnerable when floating around as individual cells in what is known as their "planktonic state" are much tougher to combat once they get established in a suitable place -- whether the hull of a ship or inside the lungs -- and come together in tightly bound biofilms. In that state, they can activate mechanisms like tiny pumps to expel antibiotics, share genes that confer protection against drugs, slow down their metabolism or become dormant, making them harder to kill.

The answer, say researchers, is to find substances that will break up biofilms.

"Since the time of Pasteur, we've been working on trying to kill off and control planktonic bacteria, but we've made very little progress in the control and understanding of biofilm bacteria," said David Davies, a biofilm expert at the State University of New York at Binghamton. "Now we're very good at getting rid of acute bacterial infections, which used to be a real scourge of mankind, but we have this incredible number of chronic, debilitating bacterial infections" often linked to biofilms.

Notorious biofilm infections come from the bacterium Pseudomonas aeruginosa, which often affects lungs and can debilitate and kill cystic fibrosis sufferers, and methicillin-resistant Staphylococcus aureus (MRSA), which can spread quickly through prisons, hospitals and even beaches. Acinetobacter baumannii infections, which plague wounded soldiers, are also probably caused by biofilms, as are more mundane afflictions such as sinusitis and ear infections.

A successful means of dispersing biofilms, Davies said, would be a medical breakthrough akin to the discovery of penicillin in 1928.

The March edition of the Journal of Bacteriology features Davies's research on forcing biofilm dispersion by using bacteria's own chemical signals against them. Biofilm colonies disperse naturally in response to environmental factors or to spread and form new colonies. Davies and his colleagues have discovered a chemical signal, in the form of a fatty acid, that tells bacteria it is time to break up.

He hopes this naturally occurring molecule, cis-2-decenoic acid or CDA, which is approved by the Food and Drug Administration as a food additive, could be used to fight infection. Because it does not kill bacteria, he says, it should not trigger the development of resistant bacteria, which could happen through natural selection if the chemical killed its targets.

At North Carolina State University in Raleigh, two chemistry professors say they might have found a potential key to biofilm dispersion in the oceans, which scientists are mining for a variety of new drugs. When John Cavanagh and Christian Melander saw photos of the sea sponge Agelas conifera looking clean and healthy on a coral reef smothered by bacterial biofilms, they had a eureka moment.

"We were looking at that and said this sponge probably has it figured out," Cavanagh said. "It has no immune system, but it's found a way to defend itself against all the biofilms in the ocean, where there is a lot of nasty stuff floating around."

Melander said "a throwaway sentence in an obscure journal" -- the Bulletin of the Chemical Society of Japan -- gave them another clue. They isolated a compound from the sponge that disperses biofilms and figured out how to synthesize it quickly and cheaply.

The professors said that in laboratory tests, the compound, paired with an antibiotic, has effectively dispersed and killed previously antibiotic-resistant forms of MRSA, A. baumannii and other bacteria, though the scientists do not know how it works.

Although they hope to pair it with antibiotics to be taken orally, Melander and Cavanagh first plan to impregnate the compound in implanted medical devices that are prone to bacterial contamination, such as catheters, stents and artificial limbs.

Similar projects are in the works at other labs worldwide.

"In the last 15 years or so, we've really seen things take off. There will be lots of novel technologies coming out," said Rodney Donlan, team leader of the biofilm lab at the Centers for Disease Control and Prevention. The agency is experimenting with using phages -- viruses that can kill bacterial cells -- to prevent biofilm formation on medical devices.

The Canadian company Kane Biotech plans to submit plans to the FDA this year for a wound gel containing a natural enzyme found in human mouths that disperses biofilms, which it has named DispersinB. The enzyme is nontoxic but makes biofilms susceptible to antibiotics and immune responses.

"The world is now turning their attention to the fact we just can't keep developing more and more drugs," said Gord Froehlich, Kane Biotech's president and chief executive. "We have to look at how the bacteria actually live and survive rather than just shooting more bullets."

University of Florida molecular biologist Tony Romeo describes the research as still in its nascent stages and said that discovering exactly why and how biofilms form is crucial.

"By understanding the factors that are needed for biofilms to develop, we hope to identify chinks in the armor that can lead to novel ways to treat or prevent such kinds of infections," Romeo said.

But dispersing biofilms without understanding all the ramifications could be a "double-edged sword," Romeo warned, because some bacteria in a biofilm could wreak worse havoc once they disperse.

"Simply inducing biofilm dispersion without understanding exactly how it will impact the bacterium and host could be very dangerous, as it might lead to spread of a more damaging acute infection," he said.

It looks like a white submarine ready to dive into the depths, with a small circular window to peer out on an imaginary sea.

It’s a hyperbaric oxygen chamber, and true to its U.S. Navy roots, time spent in one is called a dive.

"It forces oxygen into malfunctioning limbs. For diabetic wounds and wounds in general, it can start building new blood vessels in that area,” said Dr. Gerald Wootan of Jenks Health Team.

Wootan’s patients are stroke victims, children with autism, patients with peripheral vascular disease, people whose bones or soft tissue have been damaged by radiation, people with cerebral palsy, patients with skin grafts or burns, and those with any condition created or worsened by a lack of blood flow.

In fact, more parents of autistic children across the country are turning to hyperbaric oxygen therapy, chelation and a special diet to help their children. It is called the Defeat Autism Now!protocol.

As one of only two licensed health care professionals in Oklahoma listed on the Defeat Autism Now!clinician registry, Wootan sees 100 to 200 autistic children on a regular basis. Autism is a brain-based disorder that affects a person’s behavioral, social and communication skills.

Seeing progress

The parent of one of those children, Yvette Hill of Shawnee, has been thrilled with how her 11-year-old autistic son, Trent, is progressing due to hyperbaric oxygen therapy.

"Within a week, I noticed a big difference in Trent. Before, his speech was very basic and babyish talk. He would stare and laugh inappropriately. He wouldn’t look you in the eyes and he would zone out,” she said.

After a month of the therapy, "Trent was a completely different little boy,” Hill said.

U.S. researchers are launching studies on the use of hyperbarics both for traumatic head injuries and for autism. A 2006 pilot study by a Virginia researcher saw statistically significant improvements among its autistic subjects in mannerisms, health and physical behavior, sensory and cognitive awareness and speech, language and communication.

Some label this treatment for autism as quackery. But Wootan, a state-licensed osteopathic physician in good standing, sees significant benefits.

At a price of at least $400 per dive, hyperbaric oxygen therapy can be expensive. But for a diabetic seeking to ward off amputation of a limb, a 40-dive protocol can save money and a limb, Wootan said.

By immersing the patient in 100 percent oxygen at more than twice the normal atmospheric pressure, the hyperbaric oxygen treatment dissolves oxygen in the blood plasma and in all body cells, tissues and fluids at up to 10 times normal concentration, he said.

The Undersea and Hyperbaric Medical Society, the governing body of hyperbaric medicine, has approved the therapy for the treatment of 13 select conditions. Those are covered by Medicare and most insurers, he said. So-called off-label uses, such as for autism, are acceptable as long as prescribed by and conducted by licensed physicians, he said.

"It’s like any other procedure. It has to be done correctly,” Wootan said. "About 60 percent of the autistic children we’ve seen do better in behavior and function after hyperbarics as evaluated by their parents.”

Wootan hopes more research will be done to support this treatment for autistic spectrum disorders.

The Department of Managed Health Care declines to require carriers to pay for applied behavior analysis, an expensive therapy that insurers contend is an educational service, not medicine.
By Lisa Girion
March 10, 2009

California regulators said Monday that insurers must provide speech, occupational and physical therapies to their autistic members but rejected pleas to require insurers to cover the cost of behavior therapy that aims to help patients live in society.

At issue is so-called applied behavior analysis, a therapy that teaches patients skills such as self-feeding and stopping injurious behaviors such as head banging. The therapy can cost as much as $70,000 a year per patient.

Parents of children with autism have argued in lawsuits and in complaints to regulators that insurers, by refusing to pay for an array of autism care, are ignoring the Mental Health Parity Act. The 2000 state law requires insurers to treat mental conditions the same as medical conditions.

Autism is the fastest-growing serious developmental disability in the U.S., more prevalent than childhood cancer, juvenile diabetes and pediatric AIDS combined. There are an estimated 185,000 Californians with autism.

The state now treats about 37,000 significantly impaired autistic children, delivering a variety of services, including applied behavior analysis -- at a cost of more than $320 million a year.

The disorder impairs communication and socialization and is often marked by repetitive behaviors such as rocking and head banging. Its cause is unknown, and there is no cure.

The state's major insurers and HMOs routinely refuse to pay for applied behavior analysis, arguing, most recently, that it is an educational service, not medicine. The insurers also say that covering applied behavioral analysis will drive up premiums for everyone, although studies from other states have found such increases to be minimal.

Parents disputing the denials have been winning appeals to regulators in recent months as research on the effectiveness of the therapy has become more widely recognized.

In 15 of 16 recent disputes over insurance denials of applied behavior analysis for individual children, state-impaneled physician-reviewers have declared the therapy to be medically necessary. Those decisions required the insurers to pay for the treatment. The 16th case is pending.

The Department of Managed Health Care stepped into the controversy Monday, sending insurers a letter seeking to clarify their coverage obligations to cover autism and related disorders.

Parents lauded the department for making it clear that insurers must cover speech, physical and occupational therapies for their autistic members. But they were disappointed by its failure to address applied behavioral analysis.

Some said the letter set up the likelihood that parents would have to fight case by case to convince the department that the therapy should be covered. Only if they won that round would parents be able to take their case to an independent medical review panel, where they have been winning.

If not, it could be game over for parents.

"I have a problem with their staying silent on the most effective therapy," said Bay Area parent advocate Kristin Jacobson.

"Does every child who needs insulin -- or cancer treatment -- have to take it all the way to the Department of Managed Health Care?" she said. "This is the only thing where every family has to fight it every time. And that didn't stop today."

Applied behavior analysis teaches skills by breaking them down into numerous steps and drilling them with positive reinforcement.

Some studies have shown that as much as 47% of children who receive the therapy are able to enter school with no further intervention and few, if any, symptoms of the condition, said Gina Green, executive director of the National Assn. of Professional Behavior Analysts.

Eight states have laws that explicitly require insurers to cover certain autism treatments. In California there is no specific autism law. But autism is one of the conditions that was supposed to be addressed by the Mental Health Parity Act.

State officials defended the plan. "We're doing all we can within the limits of the law to make sure what should be covered is covered," said Tim LeBas, assistant director of the Department of Managed Health Care's Office of Health Plan Oversight.

Department spokeswoman Lynne Randolph acknowledged that the department would review coverage denials for applied behavior analysis case by case, trying to distinguish medical applications of the therapy from educational ones.

"We would say yes in certain instances," she said.

Kaiser Permanente and other insurers have vigorously opposed an interpretation of the law requiring them to cover the therapy.

The department's letter said it would develop regulations to formalize the requirements on insurers and to "provide additional clarity through an open and public process."

Kaiser said Monday's letter was "a step forward" but left some issues unresolved.

Charles Bacchi, interim president of the California Assn. of Health Plans, said the trade group looked forward to gaining further guidance through ongoing regulatory audits with individual insurers, as well as through the development of new regulations.

The courts may influence the course of autism coverage as well. Kaiser is the target of two proposed class-action lawsuits that accuse the company of violating the Mental Health Parity Act and other laws by routinely denying medical care, including applied behavior analysis, to its members.

Scott Glovsky, a Pasadena lawyer representing Kaiser members in one of the suits, said it was a shame that the department failed to address applied behavior analysis therapy.

"ABA is what children with autism spectrum disorders need the most," he said.

The decision applies to insurance policies held by more than 21 million Californians and supervised by the Department of Managed Health Care. That includes health maintenance organizations and some preferred-provider organizations offered by several companies, including Kaiser, Anthem Blue Cross, Blue Shield, Health Net and PacifiCare.

Harvey Rosenfield, founder of Consumer Watchdog, a Santa Monica advocacy organization, said the department might have crossed the line on "underground rule-making" by trying to change the rules by letter rather than through the formal adoption of regulations, which is a public process.

"This is a state agency winking at the HMOs and inviting them to deny claims to autistic children," Rosenfield said. "This is going to be a license to steal for the HMOs, and they are giving it away without even holding a hearing, which is just an outrage, and also, I think, illegal."

lisa.girion@latimes.com

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.

---------------------------------------------

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.

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)

---------------------------------------

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.

Physician's Warranty of Vaccine Safety

I (Physician"s name, degree)_________________________, _____ am a physician licensed to practice medicine in the State of ________________. My State license number is _______________ , and my DEA number is _______________. My medical specialty is ________________________

I have a thorough understanding of the risks and benefits of all the medications that I prescribe for or administer to my patients.  In the case of (Patient"s name) ___________________________ , age _________ , whom I have examined, I find that certain risk factors exist that justify the recommended vaccinations. The following is a list of said risk factors and the vaccinations that will protect against them:

Risk Factor ____________________________________________

Vaccination  ___________________________________________

Risk Factor ____________________________________________

Vaccination  ___________________________________________

Risk Factor ____________________________________________

Vaccination  ___________________________________________

Risk Factor ____________________________________________

Vaccination  ___________________________________________

Risk Factor ____________________________________________

Vaccination  ___________________________________________

Risk Factor ____________________________________________

Vaccination  ___________________________________________

I am aware that vaccines typically contain many of the following fillers:

• aluminum hydroxide

• aluminum phosphate

• ammonium sulfate

• amphotericin B

• animal tissues: pig blood, horse blood, rabbit brain,

• dog kidney, monkey kidney,

• chick embryo, chicken egg, duck egg

• calf (bovine) serum

• betapropiolactone

• fetal bovine serum

• formaldehyde

• formalin

• gelatin

• glycerol

• human diploid cells (originating from human aborted fetal tissue)

• hydrolized gelatin

• mercury thimerosol (thimerosal, Merthiolate(r))

• monosodium glutamate (MSG)

• neomycin

• neomycin sulfate

• phenol red indicator

• phenoxyethanol (antifreeze)

• potassium diphosphate

• potassium monophosphate

• polymyxin B

• polysorbate 20

• polysorbate 80

• porcine (pig) pancreatic hydrolysate of casein

• residual MRC5 proteins

• sorbitol

• tri(n)butylphosphate,

• VERO cells, a continuous line of monkey kidney cells, and

• washed sheep red blood

and, hereby, warrant that these ingredients are safe for injection into the body of my patient.  I have researched reports to the contrary, such as reports that mercury thimerosol causes severe neurological and immunological damage, and find that they are not credible.

I am aware that some vaccines have been found to have been contaminated with Simian Virus 40 (SV 40) and that SV 40 is causally linked by some researchers to non-Hodgkin"s lymphoma and mesotheliomas in humans as well as in experimental animals. I hereby warrant that the vaccines I employ in my practice do not contain SV 40 or any other live viruses. (Alternately, I hereby warrant that said SV-40 virus or other viruses pose no substantive risk to my patient.)

I hereby warrant that the vaccines I am recommending for the care of (Patient"s name) _______________ _______________________ do not contain any tissue from aborted human babies (also known as "fetuses").

In order to protect my patient"s well being, I have taken the following steps to guarantee that the vaccines I will use will contain no damaging contaminants.

STEPS TAKEN: ______________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

 

I have personally investigated the reports made to the VAERS (Vaccine Adverse Event Reporting System) and state that it is my professional opinion that the vaccines I am recommending are safe for administration to a child under the age of 5 years.

The bases for my opinion are itemized on Exhibit A , attached hereto, -- "Physician"s Bases for Professional Opinion of Vaccine Safety." (Please itemize each recommended vaccine separately along with the bases for arriving at the conclusion that the vaccine is safe for administration to a child under the age of 5 years.)

The professional journal articles I have relied upon in the issuance of this Physician"s Warranty of Vaccine Safety are itemized on Exhibit B , attached hereto, -- "Scientific Articles in Support of Physician"s Warranty of Vaccine Safety."

The professional journal articles that I have read which contain opinions adverse to my opinion are itemized on Exhibit C , attached hereto, -- "Scientific Articles Contrary to Physician"s Opinion of Vaccine Safety."

The reasons for my determining that the articles in Exhibit C were invalid are delineated in Attachment D , attached hereto, -- "Physician"s Reasons for Determining the Invalidity of Adverse Scientific Opinions."

Hepatitis B

I understand that 60 percent of patients who are vaccinated for Hepatitis B will lose detectable antibodies to Hepatitis B within 12 years. I understand that in 1996 only 54 cases of Hepatitis B were reported to the CDC in the 0-1 year age group. I understand that in the VAERS, there were 1,080 total reports of adverse reactions from Hepatitis B vaccine in 1996 in the 0-1 year age group, with 47 deaths reported.

I understand that 50 percent of patients who contract Hepatitis B develop no symptoms after exposure. I understand that 30 percent will develop only flu-like symptoms and will have lifetime immunity. I understand that 20 percent will develop the symptoms of the disease, but that 95 percent will fully recover and have lifetime immunity.

I understand that 5 percent of the patients who are exposed to Hepatitis B will become chronic carriers of the disease. I understand that 75 percent of the chronic carriers will live with an asymptomatic infection and that only 25 percent of the chronic carriers will develop chronic liver disease or liver cancer, 10-30 years after the acute infection.

The following scientific studies have been performed to demonstrate the safety of the Hepatitis B vaccine in children under the age of 5 years.

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

In addition to the recommended vaccinations as protections against the above cited risk factors, I have recommended other non-vaccine measures to protect the health of my patient and have enumerated said non-vaccine measures on Exhibit D , attached hereto, "Non-vaccine Measures to Protect Against Risk Factors."

I am issuing this Physician"s Warranty of Vaccine Safety in my professional capacity as the attending physician to (Patient"s name) ________________________________.

Regardless of the legal entity under which I normally practice medicine, I am issuing this statement in both my business and individual capacities and hereby waive any statutory, Common Law, Constitutional, UCC, international treaty, and any other legal immunities from liability lawsuits in the instant case.

I issue this document of my own free will after consultation with competent legal counsel whose name is _____________________________, an attorney admitted to the Bar in the State of __________________ .

 

__________________________________ (Name of Attending Physician)

__________________________________ L.S. (Signature of Attending Physician)

Signed on this _______ day of ______________ A.D. ________

Witness: _______________________________  Date: ______________________

Notary Public: ___________________________  Date: ______________________

By JON POLING, M.D.

Friday, March 13, 2009

For the million plus American families touched by autism, like mine, there is real urgency to find scientific answers to help loved ones and prevent future victims. Unfortunately, some doctors still fail to even accept the increasing autism rate as real, rather than their own better diagnosis.

The collateral damage of “better diagnosis,” the idea that we are simply better at detecting autism, is the abandonment of families coping with autism by the medical establishment, government and private insurance companies.

Beyond the high emotional toll autism takes on a family, many have been financially ruined. Public school systems are drowning in the red ink of educating increasing numbers of special-needs students.

Fortunately, the ‘better diagnosis’ myth has been soundly debunked. In the 2009 issue of Epidemiology, two authors analyzed 1990 through 2006 California Department of Developmental Services and U.S. Census data documenting an astronomical 700 to 800 percent rise in the disorder.

These scientists concluded that only a smaller percentage of this staggering rise can be explained by means other than a true increase.

Because purely genetic diseases do not rise precipitously, the corollary to a true autism increase is clear — genes only load the gun and it is the environment that pulls the trigger. Autism is best redefined as an environmental disease with genetic susceptibilities.

We should be investing our research dollars into discovering environmental factors that we can change, not more poorly targeted genetic studies that offer no hope of early intervention. Pesticides, mercury, aluminum, several drugs, dietary factors, infectious agents and yes — vaccines — are all in the research agenda.

An inspiring new text, “Autism-Current Theories and Evidence,” has successfully navigated the minefield of autism science without touching the “third rail,” as Dr. Sanjay Gupta aptly describes the vaccine-autism debate.

Dr. John Zimmerman, who has studied autism for decades, prophetically writes, “The clinical heterogeneity of this disorder, together with the inherent dynamic changes during children’s growth and development, confound static, linear models and simplistic, unilateral approaches.”

Zimmerman’s book is dense with cutting-edge science on cell biology, metabolism, oxidative stress, neuroinflammation, auto-immunity and brain pathology. That’s right — autism isn’t simply a genetic program for brain development gone awry. Dr. Martha Herbert, of Harvard Medical School , writes the final chapter defining autism in the larger framework of a multiple organ system disease with potentially reversible impairments.

As an affected parent, I am left with a sense of hope that these professionals will produce results to stem the tide of new autism cases and ameliorate symptoms of those currently suffering.

On the other hand, Dr. Paul Offit, the vaccine inventor whose Rotateq royalty interests recently sold for a reported $182 million, has written a novel of perceived good and evil called “Autism’s False Prophets.”

The tome is largely a dramatic account of why Offit, who self-admittedly is not an autism expert, feels vaccines should be exonerated in the autism epidemic. In the story, Offit takes no prisoners, smearing characters in the vaccine-autism controversy as effortlessly as a rich cream cheese.

“False Prophets” has curiously garnered support from several senior physicians in respected medical journals.

After Offit’s drama is complete, these cheerleaders fail to realize they have traveled the road labeled “Dead End — No Through Traffic.” In his epilogue, Offit credits autism parents who have likewise gone down the dead end path to autism acceptance, without search for cause or cure.

As both parent and doctor, I cannot fathom turning my back on a child nor science, in order to avoid inconvenient questions about vaccine safety or any other reasonable environmental factor.

President Obama has recognized that “we’ve seen just a skyrocketing autism rate” and plans to appoint an “autism czar” to coordinate his policy efforts. Science is moving forward to connect the three dots of environment, genes and plasticity of a developing child’s brain circuitry. In the end, logic and reason will prevail over politics and profits.

• Dr. Jon Poling, an Athens neurologist, is an assistant professor at the Medical College of Georgia. His daughter, Hannah Poling, has been a successful petitioner in the National Vaccine Injury Compensation Program.

By Rev. Lisa K. Sykes
Foreword by Lenny Schafer, Editor of The Schafer Autism Report
Epilogue by Mark Geier, MD, PhD, and David Geier

SACRED SPARK ILLUMINATES BIOMEDICAL TREATMENTS FOR MERCURY POISONING, EMPOWERS PARENTS AND PHYSICIANS TO QUESTION VACCINE SAFETY ISSUES AND IGNITES A GLOBAL DEBATE ON VACCINES AND AUTISM

“This book is an inspirational story of one family’s struggle with autism, and one woman’s determination to protect our children from the insidious poison of mercury. Thomas Jefferson once wrote that ‘[t]he care of human life and happiness and not their destruction is the first and only legitimate object of good government.’ Reverend Sykes’ long battle to uncover the truth about the link between mercury and autism is a painful lesson to us all that our government is failing this test when it comes to our Nation’s epidemic of autism. Through her faith and trust in God, Reverend Sykes shows us all how to triumph in the face of adversity and reminds us that one person can indeed make a difference.” – Congressman Dan Burton

Sacred Spark is the compelling true story of a child affected by mercury-poisoning and his minister-mother’s decade-long battle to restore the light in his eyes. It is also the inspiring story of Reverend Sykes' work with the United Methodist Church to pass the first global resolution advocating the elimination of mercury from medicine, a nascent social justice movement on par with historical faith-based campaigns against child labor and slavery. With pragmatism and compassion, Sacred Spark calls for putting the well-being of children first. Through Sacred Spark’s unflinchingly honest, first-person account, parents and physicians demanding safer vaccines will find clarity to support their informed choices as well as inspiration and guidance to become advocates for children. Rev. Sykes’ own journey from healing mother to global child advocate and spiritual leader is stunning in its intensity and humanity. Woven seamlessly into the book’s engrossing narrative are Rev. Sykes’ victories in appropriate and landmark biomedical treatments for her son, the success of empowered parents to enact state bans on mercury and to approach Attorney Generals across the country, attempts to find precious allies against a corrupt and protected industry, and her family’s lawsuit defeat against a pharmaceutical company.

Rev. Sykes’ story begins when she shares with the reader her family’s horror in witnessing their happy toddler regress into autism. When her son is clinically diagnosed with mercurypoisoning due to the therapeutic use of vaccines, Rev. Sykes initiates a letter-writing campaign to federal officials and agencies with the aim of protecting all children from disability through mercury in vaccines.

Disillusioned when her goodwill attempts are consistently thwarted, Rev. Sykes joins other parents from across the nation with children who are mercury-toxic. As a resolute and informed force they capture national media attention, lobby national and state congressmen and implore national health agencies and federal oversight agencies to protect pregnant women, infants and children from the undisclosed administration of mercury in medicine – a basic safety denied them.

The book’s fast-paced storyline whisks the reader from the Simpsonwood United Methodist Retreat Center in Norcross, Georgia, (where a closed-door meeting between government officials and pharmaceutical companies was convened one week before congressional investigations into conflicts of interest between the two began in 2000), to the floor of the Institute of Medicine meetings in Boston and Washington, DC, where Rev. Sykes passionately challenges committee members to abandon their blind trust in how vaccines are manufactured and approved and embrace instead the clarity of medical ethics that would put children first. Cited extensively throughout the book are scientific studies supporting mercury’s causal role in autism, as well as the internal transcripts from the IOM and Simpsonwood meetings and government emails (available through the Freedom of Information Act).

In stark contrast to the stubborn failure of the federal government to act on behalf of the nation’s children, Rev. Sykes brings her cause to The United Methodist Church and her denomination responds with the strength and support of its 11.5 million members in a global resolution advocating the elimination of mercury in medicine. Sacred Spark seeks to answer, as well as raise, such questions as: How does a parent or practitioner initiate the reforms necessary to protect minds from mercury? Why do the Hippocratic Oath and the Right of Informed Consent apply to all parts of medicine, especially vaccination? How do we counter the argument that a mercury-containing vaccine is better than no vaccine at all, as global dissemination of mercury-containing vaccines to the Developing World continues? Why do the public and media believe mercury is out of vaccines when there has never been an official recall or ban and more has been added with flu shots?

As a Princeton Theological Seminary graduate and minister of nineteen years, Rev. Sykes inspires the reader to go beyond compromised scientific studies and profit-driven political debates, and examine the mercury/autism issue through the first-hand experience of a mother and the faith and conviction of a minister. Sacred Spark ultimately teaches us that it is ordinary people who ignite the fire of reform.

If you aren’t sure how this matters, keep reading.

Starting today, March 19, we’re kicking off a massive campaign to tell Merck how we feel. The National Vaccine Information Center (www.nvic.org) and Age of Autism (www.ageofautism.com) and many dozens of parent support groups will join us in spreading the word. We expect to hear from hundreds of thousands of parents who will be writing, faxing, e-mailing and calling in.

Feel free to use some or all of the letter that appears below. Be sure to add your full name, address and the date. Don’t forget to sign it, too! If you have time, please complete steps #1 through #4.

1) Send the letter to: Mr. Richard T. Clark, CEO, Merck & Company, One Merck Drive, PO Box 100, Whitehouse Station, NJ 08889-0100

2) Fax the same letter to 908-735-1244 (back up fax 908-735-1500 or 215-993-1220)

3) E-mail the same letter to Richard_clark@merck.com and copy vaxRSVP@verizon.net. Make sure the newly saved word document contains your name, address and date.

4) Call Merck and deliver the message directly: 908-423-1000 and ask for the office of the CEO (back up number (800) 672-6372, press 2, then press 3)

Tell your friends and family to do the same. Use Facebook and the other ways you keep in touch. Make the contact with Merck and we’ll report back to let you know what we’re hearing. We also know that parents are searching high and low, traveling the globe and spending thousands of dollars to locate the individual vaccines. Send your “Finding M, M and R” stories to vaxRSVP@verizon.net.

Thanks,

Louise Kuo Habakus

Here's the suggested letter:
Your address
Town, state, zip

Today’s date

Richard Clark, CEO
Merck & Company
One Merck Drive PO Box 100
Whitehouse Station, NJ -8889-0100

Dear Mr. Clark,

I am writing to express my extreme disappointment regarding Merck’s recent announcement to discontinue production and sales of the individual (monovalent) measles, mumps, and rubella vaccines in the United States. I am asking you to seriously consider revoking this decision. I join the ranks of hundreds of thousands of parents who are angry that we are now forced to give our children the combination MMR vaccine. The ramifications of your corporate decision are deeply troubling. They will weaken compliance and serve to further widen the trust gap between parents on the one hand and government and industry on the other. The net effect will undermine public health policy. Perhaps you have not considered the full impact of your decision. Please consider the many ways that parents are connecting the dots. There are urgent reasons why you must continue to manufacture the monovalent vaccines.

Defacto Increase in Number of Mandated Vaccines
Vaccines are mandated for daycare and school admission at the state level. All states mandate one dose each of measles, mumps and rubella vaccines around the child’s first birthday. Many states, however, also mandate a second measles vaccine prior to kindergarten. By eliminating the option to administer a single second measles vaccine, you have effectively increased the number of mandated shots these children are required to receive. Some parents will choose to forgo rather than double up.

More Injuries Caused By Combination Vaccines
Combination vaccines are documented to cause more injuries. The motivation behind the development of combination vaccines had less to do with therapeutic benefit or safety and more to do with cost, convenience, compliance and perceived parental discomfort caused by seeing their baby pierced with multiple needles.

Simultaneous Shots Neither Recommended Nor Adequately Studied
Merck and other vaccine makers have never studied the merits and safety of giving multiple shots during the same office visit. You admit as much in your own MMR package insert: “Routine administration of DTP and/or OPV concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.” www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

Physician Flexibility to Individualize Patient Protocol is Eliminated
Doctors must have the option to assess a child’s family history and individual circumstances and modify the recommended protocol accordingly. Many parents are already working with their doctors and are on track to have their children receive their recommended shots using the monovalent vaccines and a modified timeline. Your decision removes an important option that doctors have to administer the vaccines separately and more safely.

Ethical and Religious Concerns Regarding Ingredients
The rubella vaccine is cultured on aborted fetal tissue. Some will choose to avoid this shot for moral or religious reasons. If the combination MMR is the only option to protect against measles and mumps, some of these parents will skip this vaccine altogether.

Controversy Surrounding Combination MMR Vaccine Affects Compliance
There is a raging debate regarding the safety of the combination measles, mumps and rubella vaccine. Despite attempts by government health officials to dismiss parent fears, public concern remains. Offering the option to use either the combination or single dose vaccines supports the informed consent ethic, strengthens the patient-physician relationship and enhances the integrity of the national vaccine program. Overall compliance is improved. Without the choice, parents will increasingly opt against vaccination rather than be forced into giving their children the combination MMR shot.

There is a robust market for the individual vaccines. Please demonstrate to parents that you understand our legitimate concerns. Merck should act responsibly and continue to offer the individual measles, mumps and rubella vaccines. Thank you.

Sincerely,