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Reps. Maloney and Smith Ask HHS to Fund Vaccinated-Unvaccinated Study with Federal Stimulus Money

Posted: 06/12/09 01:32 PM ET

On Wednesday, Rep. Carolyn Maloney (D-NY) and Rep. Christopher Smith (R-NJ) called on HHS Secretary Kathleen Sibelius to dedicate between 1.6% and 6.6% of the $300 million in federal stimulus funds earmarked for the purchase and distribution of vaccines to fund a major study of health outcomes -- including autism -- among vaccinated and unvaccinated people.

The move comes just one week after the federal government's National Vaccine Advisory Committee also unanimously voted to recommend a feasibility study on conducting the controversial investigation.

Some federal officials have balked at doing a vaccinated-unvaccinated study, citing its high cost -- which Maloney and Smith said would fall in the $5-$20 million range.

"Indeed, this was part of the rationale provided by Dr. Thomas Insel, Director of the National Institute of Mental Health, when he obtained a reversal of a previous vote," backing the study at the Federal Interagency Autism Coordinating Committee, which Dr. Insel chairs, the lawmakers wrote.

But, they noted, "The American Recovery and Reinvestment Act has authorized $300 million in new funding to promote the purchasing and distribution of vaccines. Surely, dedicating resources to fundamental safety research should command as high a priority as increasing our already generous purchasing practices for childhood vaccines."

Another obstacle often cited by opponents, Maloney and Smith said, is that the number of unvaccinated children in the United States is "too small or too different to permit a valid study."

But as they noted, Duane Alexander, Director of the National Institute of Child Health and Human Development (who also supports more vaccine-autism research), has said that the National Children's Study -- with its 100,000 children in the sample -- "may itself contain several thousand unvaccinated children." And, they added, children such as the home schooled and the Amish, "with known reduced vaccination rates" could be recruited to gain higher numbers.

As for "differences" among the unvaccinated, Maloney and Smith wrote that, "refusals are rising among the most affluent, educated and professional parents," many of whom, Maloney noted, live in her Manhattan district. "Indeed, it is the rise of such refusals that lends urgency to the need to investigate the safety of our current childhood vaccine program," the lawmakers said.

Maloney and Smith are cosponsors of the House "Comprehensive Comparative Study of Vaccinated and Unvaccinated Populations Act," which they will reintroduce in the coming weeks. They wrote to Secretary Sibelius seeking her "support in furthering the goals" of the bill.

Just last week, the National Vaccine Advisory Committee recommended asking an expert panel, such at the Institute of Medicine, to weigh in on the strengths, weaknesses, ethical issues and costs of studying and comparing vaccinated, unvaccinated, and "alternatively vaccinated" groups of children for a number of disorders -- including autism.

Prospective clinical trials, where children would be randomized into vaccinated and placebo groups, would be unethical. But NVAC suggested one publicly submitted idea to conduct an "observational study" looking at, "natural variation in vaccination schedules, including some children where vaccination is declined through parental intent."

The recommendation was made to Sibelius's DHHS.

The Obama Administration has now been asked -- on the record -- to weigh in on two key controversies in the ongoing vaccine-autism debate. Also this week, the US Supreme Court asked the Administration for its opinion on whether autism families should be able to file thimerosal lawsuits against drug companies in civil court or not.

These are two big, looming decisions, and the autism world will be watching very intently.

Will the Obama people come down in favor of federal preemption for pharmaceutical products over the legal rights of families? And will they ignore the advice of their own National Vaccine Advisory Committee and try to shut down research to close a wide gap in our knowledge of immunization safety?

We will find out soon enough.

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ON A SIDE NOTE: SEVEN STUDIES TO WATCH

Yesterday, I wrote that US officials had approved or recommended seven new studies somehow related to autism and vaccination, including a major new prospective study by several NIH agencies.

I have listed them here on one page, for readers who might want to share it with medical personnel, family members, elected officials, members of the media and anyone else who tells them that the vaccine-autism debate is over and done with.

Anyone complaining about parents asking for more research should direct their ire at the following US Government agencies and affiliated groups, who concur that many gaps in vaccine-safety research remain:

US Department of Health and Human Services
US Environmental Protection Agency
US Centers for Disease Control and Prevention
National Institutes of Health
National Institute of Environmental Health Sciences
National Institute of Mental Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke
National Vaccine Advisory Committee

APPROVED STUDIES:

1) The National CADDRE Study -- This 5-year project of the CDC's Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network will "help identify what might put children at risk for autism," the CDC says. Among those risk factors: "specific mercury exposures, including any vaccine use by the mother during pregnancy and the child's vaccine exposures after birth."

2) The National Children's Study - This HHS-EPA joint effort will investigate "the effects of environmental influences on the health and development of more than 100,000 children across the United States," including autism. As part of their work researchers will track medical records, including vaccinations and their impact on neorodevelopment.

3) The Early Autism Risk Longitudinal Investigation (EARLI) - This network of NIH agencies (NIEHS, NICHD, NIMH, NINDS) and affiliated sites will follow 1,200 pregnant women who already have a child with autism, to identify the "earliest possible environmental risk factors and their interplay with genetic susceptibility during the prenatal, neonatal and early postnatal periods." Potential risk factors in the study include vaccines, thimerosal, and heavy metals.

RECOMMENDED STUDIES

On June 2, 2009, the Federal Government's National Vaccine Advisory Committee voted unanimously to recommend a sweeping list of vaccine safety studies, including four related to vaccines and autism. The CDC had previously proposed studying autism as a "clinical outcome" of vaccination, and NVAC concurred. The document can be viewed at:

4) Study the Feasibility of Comparing Vaccinated, Unvaccinated and Alternatively Vaccinated Children - NVAC recommended asking an expert panel, such at the Institute of Medicine, to weigh in on the strengths, weaknesses, ethical issues and costs of studying and comparing vaccinated, unvaccinated, and "alternatively vaccinated" groups of children for a number of disorders - including autism. Prospective clinical trials, where children would be randomized into vaccinated and placebo groups, would be unethical.

But NVAC suggested one publicly submitted idea to conduct an "observational study" looking at, "natural variation in vaccination schedules, including some children where vaccination is declined through parental intent."

5) Study Vaccine-Mitochondria-Autism Links - "Recent developments around mitochondrial dysfunction reinforce the importance of studies of vaccine adverse events in rigorously defined subsets of the ASD spectrum," the NVAC wrote. The rate of mitochondrial dysfunction in autism has been estimated at somewhere between 7%-to-30% of all ASD children. "Mitochondrial dysfunction carries an established risk of brain damage subsequent to infectious disease," the NVAC wrote. "Thus, a small and specific subset of the general population (such as those with mitochondrial dysfunction) may be at elevated risk of reduced neurological functioning, possibly including developing ASD, subsequent to live virus vaccination."

6) Study Vaccines and Regressive Autism - "In the context of vaccination research, the ASD clinical subset of particular interest is regressive autism" the NVAC wrote. Estimates of ASD regression range from about 15 to 50% of all ASD cases, depending on the definition used. "Regressive autism does fit the recommendations of the IOM (immunization) committee for further research in rigorously defined subsets of ASD," the NVAC said. Such studies might entail, "prospective vaccination response profiling in siblings of children with regressive ASD, a subpopulation who are at higher risk."

7) Study Vaccine Injuries and the Risk of Autism - Another autism subpopulation that should be included in vaccine studies is what the NVAC called "the intersection of ASD cases with (clearly defined vaccine outcomes) such as fever, febrile seizure, or hypotonic-hypo-responsive episode (HHE)." Do these adverse effects correlate with ASD? "It would be worthwhile to assess," the NVAC wrote. "On a molecular level, it might be feasible to compare ASD cases with history of adverse events following immunization against cognitively normal controls with a similar history of adverse events, to assess whether there are significant differences in immune response profiles between groups."