ARI - Vaccines: The issues and ARI's Vaccine Initiative

Autism Research Review International, 2009, Vol. 23 (1), pp. 3 and 7
Editor’s Notebook:
Vaccines: The issues and ARI’s Vaccine Initiative

Stephen M. Edelson and Jon B. Pangborn
Autism Research Institute
4182 Adams Avenue, San Diego, CA 92116

Vaccine safety is of great importance to our society because it balances the indisputable need for disease prevention and public health against the potential for harm to an individual. The Autism Research Institute (ARI) is particularly concerned with vaccine safety because of innumerable testimonies from parents that autistic traits have appeared in their children following vaccinations—especially after multivalent ones such as the “measles, mumps, and rubella” and vaccines containing the mercury-based preservative thimerosal.

Over the past several years, parent-sponsored advocacy groups and some physicians have begun raising awareness among the public and government agencies regarding a possible relationship between vaccines and autism. In addition, these parent-led groups recommend specific treatments to counteract the perceived adverse effects of vaccines.

At ARI, we also recognize that retrospective, correlative epidemiologic studies by most researchers have failed to conclude that there is a link between the onset of autism spectrum disorder (ASD) and vaccinations, although some studies suggest a link to thimerosal. However, many of these studies demonstrating no or minimal adverse effects of vaccines have been funded by pharmaceutical companies, government agencies, or individuals who profit from vaccine development and use. These actual or perceived conflicts of interest undermine public confidence and ill-serve those with genuine concern for public health while raising suspicions of parents. Parents want to know all the affiliations of the investigators and the compensations that they have received.

Vaccine administration is mandated by individual states for infants to be enrolled in day-care or public school systems; therefore, vaccines should be held to the highest standards with regard to safety and efficacy. Moreover, investigations of safety and efficacy should be conducted by experts who are truly independent and impartial. And finally, in almost every published study showing no or minimal adverse effects as a result of vaccines, authoritative reviewers have raised reasonable questions regarding the validity of the data, the statistical methods employed, and/or the experimental design.

ARI desires to be an advocate for and an initiating force behind thorough and unbiased vaccine safety studies. We don’t wish to be alone in this endeavor, and we are not out to denigrate vaccinations. We advocate studies that will conclusively decide issues such as whether there are risk factors for autism linked to vaccines, the appropriateness of alternative vaccination schedules, and whether there are telltale signs or measurable markers of concern prior to vaccination.

Individuals and subgroups of populations with ASD have been found to have immune dysregulation in many investigations. At least a dozen expert studies now have identified or confirmed persistent inflammation in many individuals with ASD in brain tissue, the intestinal tract, or both. Studies using cells and tissues have indicated trouble detoxifying heavy metals (including mercury) and organic xenobiotics such as pesticides. Metabolic processes that regulate cellular energy, immune response, and endocrine functions have been cited as problems in ASD populations. Recently, mitochondrial dysfunction has been implicated as a predisposing condition. And a handful of studies, most of them funded by parents and parent advocacy groups, have documented physiological abnormalities in children on the autism spectrum that are consistent with a vaccine etiology.

Some independent researchers have replicated these findings, while others have not. Can the pathology of autism be triggered by vaccination? And if so, when does it occur?
To us at ARI, it appears that predisposing conditions, including many of genetic origins, can lead to ASD via an infectious or toxic insult that occurs at the wrong time—during gestation, infancy, or other critical periods of development. The result is a persistent maladaptation involving inflammation, immune activation, epigenetic changes, lack of neuronal connectivity and synchrony, lack of integrative and responsive thought, and a deficit of expressive speech.
Many investigations of suspected triggering stressors have been published. We at ARI are very concerned about organochlorines (dicofol, endosulfan), organophosphates (diazinon and others requiring enzymatic detoxication via paraoxonase), mercury and other heavy metals in their various chemical forms, and the whole of our contaminated environment. Vaccines are not our sole focus, but they are on our list of environmental suspects until proved otherwise.
To date, research into vaccines and autism has been inconclusive largely because of the limitations and confounds inherent in most of the studies. Basically, the vaccine/autism issue has involved four separate issues:

· The vaccines themselves (e.g. MMR, DPaT).
· Adjuvants used to make vaccines more effective (e.g. aluminum).
· Preservatives (such as thimerosal).
· The timing and the number of vaccine injections—in other words, the age of first vaccination and the time intervals between vaccinations.

In general, investigators have focused primarily on one of these four issues. However, it is also important to consider the potential adverse effects of a combination of two, three, or possibly all of them.

An additional issue is the presence of illness, inflammation, oxidative stress, metabolic dysfunction, or toxicity that needs to be taken into consideration because these may be predictors of children who have increased risk of developing autism. The medical profession advises caution when giving vaccines to individuals with compromised immune systems because these individuals are considered to have a higher risk for vaccine injury. We recommend that children who are sick have the vaccinations rescheduled to a time of wellness. We would like to see a marker for oxidative stress or inflammation checked before vaccination because both of these problems are perpetuating circumstances described in many children with autism. We also believe that a pregnant woman should never get a shot that contains any form of mercury or aluminum because the safety of mercury and aluminum has not been adequately studied. It is important to mention that the flu shot still contains mercury. Indeed, removal of mercury from all vaccines would be judicious and would help foster public confidence and compliance with government vaccination policies.

The debate over the autism/vaccine connection is more than ten years old, and it will likely continue for many more years. Clearly, the most effective way to resolve this issue is for the scientific and medical communities to communicate and coordinate efforts to study the issues associated with vaccine safety. The results from this research will be accepted by the scientific and parent communities only if the investigations and the investigators are honest, thorough, and clearly unbiased. The research must be multi-faceted, involving epidemiological studies, cellular and animal models, in-depth parent interviews, and evaluations of infants who have an adverse vaccine reaction. There should be careful monitoring of children before and after receiving vaccines, and this should include objective physiological measures.

Last year, ARI began a one-million-dollar puzzle piece campaign to raise funds to organize and coordinate scientific investigation on vaccine safety. When we achieve this financial goal, we will recruit medical and scientific professionals from both sides of the issue to develop objective experimental designs that will truly enable careful investigation of the various issues of vaccine safety. One hundred percent of the monies raised by the campaign will be used for this project.
In addition, ARI will fund many of these studies and will actively encourage governmental and other health care agencies to sponsor and fund this line of research.

Vaccines are an integral part of modern medicine, but we feel their safety has not been adequately studied. Not only do children get more vaccinations than their parents received, but all of us now are exposed to increased kinds and amounts of toxic stressors. The stakes are high and the nation needs, once and for all, answers to the pressing questions regarding vaccines and their possible relationship with autism. If the research reveals a true relationship between vaccines and autism, changes in healthcare can and should be made immediately to benefit society as a whole, as well as future generations of children.