The Inter-Agency Autism Coordinating Committee (IACC) has voted to recommend earmarking millions of dollars in research funds from the Combating Autism Act of 2006 to study the possible role of vaccines in the causation of autism.
The panel also proposed spending an additional $75 million to study a wide variety of other environmental factors in autism, possibly including parental age, infections, heavy metals, neurotoxins, occupational exposures and "other biological agents."
The decision, made last month, received little or no attention in the media. The vaccine research provisions are now included in the official IACC Draft Strategic Plan for Autism Spectrum Research.
The IACC has 12 members from various health-related branches of the Federal Government, plus six "Public Members," including representatives from Autism Speaks, the Autism Society of America and the Coalition for Safe Minds, as well as Stephen Shore, an adult on the autism spectrum.
Section III of the Strategic Plan is titled, "WHAT CAUSED THIS TO HAPPEN AND CAN THIS BE PREVENTED?" The section is divided into various parts, including short- and long-term research objectives. Much of the section is devoted to studying the interactions of genetic susceptibilities with potential environmental triggers, including vaccines.
In fact, two vaccine-autism studies have been approved by the IACC, which has proposed spending $16 million to:
1) "Study the effect of vaccines, vaccine components, and multiple vaccine administration in autism causation and severity through a variety of approaches, including cell and animal studies, and understand whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines by 2011. Proposed costs: $6,000,000
2) Determine the feasibility and design an epidemiological study to determine if the health outcomes, including ASD, among various populations with vaccinated, unvaccinated, and alternatively vaccinated groups by 2011. Proposed costs: $10,000,000
Additionally, under "Research Opportunities," the panel also endorsed this objective:
"Monitor the scientific literature regarding possible associations of vaccines and other environmental factors (e.g., ultrasound, pesticides, pollutants) with ASD to identify emerging opportunities for research and indicated studies."
For proponents of vaccine-autism research, this is a resounding victory. It covers much of what these advocates have been supporting for a number of years. It is also sure to enrage those who are opposed to such research.
But for now, it has been recommended that the US Federal Government spend millions of dollars to study not just thimerosal, (a mercury based vaccine preservative), not just the triple live virus MMR vaccine, but vaccines in general, all ingredients that go into vaccines and, most surprisingly, the effect of "multiple vaccine administration" in the causation of autism.
This document also marks the closest we have come, perhaps, to conducting a study of health outcomes among vaccinated vs. unvaccinated children in the United States. With a price tag of $10 million just to study its feasibility and to design a study, such a project would indeed be costly and cumbersome. But, as CDC Director Dr. Julie Gerberding has said, this is a study that "should and could be done." (There is a bill pending in Congress right now that would provide funding for a vaccinated-unvaccinated study).
But vaccines, of course, are not the only candidates for study in the etiology of autism. There is a growing consensus now that most autism cases arise from an unknown combination of environmental agents, probably interacting with certain genetic predispositions.
The IACC Strategic Plan contains an impressive array of objectives and ideas on studying possible environmental factors. Not surprisingly, there was significant dissention on whether vaccines should still be considered among the list. On this thorny subject, the Strategic Plan says the following:
"Research on environmental risk factors is also underway. An Institute of Medicine workshop held in 2007 summarized what is known and what is needed in this field (Institute of Medicine of the National Academies, 2007). Numerous epidemiological studies have found no relationship between ASD and vaccines containing the mercury based preservative, thimerosal (Immunization Safety Review Committee, 2004). These data, as well as subsequent research, indicate that the link between autism and vaccines is unsupported by the research literature. Some do not agree and remain concerned that ASD is linked or caused by vaccination through exposure to Measles Mumps Rubella (MMR), imposing challenges to a weakened immune system, or possibly due to mitochondrial disorder.
Public comment to the Committee reflected opposing views on vaccines as a potential environmental cause. Some contend that cumulative research on this topic indicates no role of vaccines in autism. Others contend that definitive research has not been done. A third view argues that the persistent focus on vaccines and other possible causes is misplaced.
In addition, a number of other environmental agents are being explored through research that are known or suspected to influence early development of the brain and nervous system. Recent studies suggest factors such as parental age, exposure to infections, toxins, and other biological agents may confer environmental risk. These findings require further investigation and testing."
Meanwhile, on the critical subject of interactions between genes and the environment, the panel says this:
"Although most scientists believe that risk factors for ASD are both genetic and environmental, there is considerable debate about whether potential environmental causes, genetic precursors, or interactions between genes and environmental factors should be the highest priority for research aimed at identifying the causes of ASD.
To date, few studies have ruled in or ruled out specific environmental factors. While there are reports of associations of ASD with exposure to medications or toxicants prenatally, and to infections after birth, it is still not known whether any specific factor is necessary or sufficient to cause ASD. Similar to other disease areas, advancing research on the potential role of environmental factors requires resources and the attraction of scientific expertise. Bringing this to bear on autism will help focus the environmental factors to study, as well as the best approach for staging studies to examine environmental factors, interaction between factors, and between individual susceptibility and various environmental factors."
The panel also weighed in on the possibility that "de novo," or spontaneous changes in gene structure - perhaps triggered by environmental factors - may be a factor in the causation of autism:
"(Recent) findings have contributed to new hypotheses about the inheritance of ASD. In families with just one affected member, spontaneous deletions and duplications may be causal factors of ASD. However, what causes these spontaneous deletions and duplications is not clear and possibly could be due to environmental exposures."
It also voted to recommend the following studies of environmental factors in autism, for which it proposed a budget of more than $75 million:
1) "Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene - environment research by 2011."
2) "Initiate studies on at least five environmental factors identified in the recommendations from the 2007 IOM report "Autism and the Environment: Challenges and Opportunities for Research" as potential causes of ASD by 2010."
3) "Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015."
4) "Conduct a multi-site study of the subsequent pregnancies of 1000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014."
5) "Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect nested, case-control data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015.
Some people may object to even this moderate sum of federal research money going into possible environmental factors. After all, the 2007 IOM Report from which the "five environmental factors" to study will be chosen, includes the following suggested areas of inquiry:
Heavy metals and cosmetics
RhoGAM exposure (Rho-D immune-globulin, which contained thimerosal until 2003)
"Major priority" pollutants
Toxins from industrial disasters
Prenatal exposures to infectious diseases
People who would object to studying these factors, it should be noted, are a tiny minority and a dying breed.
Far more controversial will be the inclusion of any vaccine wording within the research matrix, even though Members of Congress made it clear in the Colloquy* and Report Language of the Combating Autism Act that vaccines and other environmental factors should be studied. But the dissenting voices are coming through loud and clear in the following proposed (but not yet finalized) passage:
"Those who are convinced by current data that vaccines do not play a causal role in autism argue against using a large proportion of limited autism research funding toward vaccine studies when many other scientific avenues remain to be explored. At the same time, those who believe that prior studies of the possible role of vaccines in ASD have been insufficient argue that investigation of a possible vaccine/ASD link should be a high priority for research (e.g., a large-scale study comparing vaccinated and unvaccinated groups). A third view urges shifting focus away from vaccines and onto much-needed attention toward the development of effective treatments, services and supports for those with ASD."
Of course, it remains to be seen if these vaccine studies survive into the final version of the IACC Strategic Plan. And even if they do, that does not guarantee they will be fully implemented.
But one thing seems pretty clear, as we head into the last year of the century's first decade: Much to the chagrin of many, the vaccine-autism debate is anything but over.
*NOTE: In the Senate Colloquy, Sen. Mike Enzi, who was Chairman of the Committee (H.E.L.P.) that developed the bill, said this: "I want to be clear that, for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder. Thus, I hope that the National Institutes of Health will consider broad research avenues into this critical area. No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know.
Meanwhile, Co-Sponsors Santorum and Kennedy agreed with Enzi's statement, and Senator Chris Dodd added this: Through the Combating Autism Act, all biomedical research opportunities on ASD can be pursued, and they include environmental research examining potential links between vaccines, vaccine components and ASD."