The National Children's Study, with Salt Lake City as one of its "vanguard" sites, may be dead before the first child is enrolled.
The president's FY2007 budget doesn't contain a penny for the study, which would be the first large-scale longitudinal study of children's health issues in the nation's history. The budget proposal goes a step beyond simply defunding, directing the study be closed down.
Now children's advocates are vowing to lobby Congress to obtain the money to keep the study alive.
Congress created the study in 2000. More than $50 million has been "cobbled together" to design the study and to prepare for its implementation since then, said Dr. Edward B. Clark, medical director at Primary Children's Medical Center, head of pediatrics at the University of Utah and the Utah study center's principal investigator.
The study was to enroll about 100,000 children from before birth to age 21, tracking psychological, social, environmental and genetic factors that impact wellbeing, with an emphasis on what happens in pregnancy, birth defects, asthma, obesity, diabetes and autism, among others.
But the Office of Management and Budget this week announced that "The National Children's Study planning activities that are ongoing in FY2006 will be brought to a close by the end of the fiscal year. There are no plans for the NIH to continue the full-scale study in FY2007."
"We've been given no explanation for it.. . .To pull the plug on it is inexcusable," Clark said.
Most surprising was the directive to stop the study, said Dr. Alan R. Fleischman, chairman of the study's federal advisory committee.
"Mothers and fathers of America are asking doctors every day questions that we cannot answer," he said, adding the study promises to provide some of those answers.
Clark said he has not been told directly to stop study-preparation activities, and he is moving forward with work in Utah. He's just started hiring staff for the study. He also plans to join other principal investigators to lobby Congress. "I'm counting on members of Congress to recognize and put this relatively small amount of money back into the budget so we can move forward with the most bold and innovative initiative for children's health that has ever occurred.
"I'm going to move ahead until I'm told in no uncertain terms by Congress that they don't want it. I view the president's budget as a suggestion," said Clark, who added he hopes a public outcry will put children's long-term health issues back among the nation's priorities.
Long-term study of children's health has been largely ignored, said Dr. Scott Williams, a pediatrician who works for HealthInsight and is not directly involved in the National Children's Study.
For many years, even clinical trials of potential treatments that might be used on children only enrolled adult participants, as if children were just small-scale adults. Now drugs and other treatments that might be used by children must have a child component to the testing.
And while there have been many short-term studies focused on treating diseases in children, Williams said, a longitudinal study like the planned study provides long-term, cause-and-effect information that is difficult to piece together any other way.
"We have this concern: There are things in our environment that may contribute to diseases long-term," Williams said. Such a study could provide some answers; it could perhaps even help sort out questions of nature v. nurture.
"I'm very disappointed this was defunded," Williams said.
Clark said the expected cost about $70 million this coming year to get going and another $150 million a year to carry it out, seems like a small amount compared to the billions that are spent each year on children's health problems. "I really think a country that fails to invest in its children is morally bankrupt," he said.
Fleischman acknowledged unusual financial challenges this year, such as hurricanes like Katrina that have dramatically impacted the federal deficit. "But this was really an outrageous directive," he said.
And there is apparently some money available for research. A study to be conducted by the Human Genome Institute appears in the president's budget with an allocation of $68 million an allocation almost identical to the amount previously expected for the children's study.
"That is not a study about children," said Fleischman. "It's about adults. Children are again being ignored, and it's short-sighted to ignore children who, of course, become adults. Our study could answer questions about predisposition to disease by managing factors that impact on future health."The genetic study, proposed by the Department of Health and Human Services, says it will look at genetic and environmental factors of diseases, with only a small component concerning children, Fleischman said.