How the U.S. Government Botched Its Multibillion-Dollar Plan to Beat Childhood Disease.

http://www.businessweek.com/articles/2014-12-23/how-the-national-childrens-study-fell-apart

In the late 1990s, scientists studying children's health pondered crucial questions they couldn’t answer: Conditions as diverse as asthma and autism were increasing in prevalence, with no clear reason why. Many suspected that a child’s early environment—even exposures in the womb—were connected to medical problems that manifested years later. For example, is risk of asthma influenced by the stress a mother experiences during pregnancy? What role does air pollution play? What about diet? Those links proved difficult to study because by the time a child shows signs of asthma, it's too late to take a blood sample during pregnancy, or analyze the air the newborn breathed.

To address those challenges, leading pediatric researchers in the U.S. envisioned an ambitious study. They wanted to track 100,000 American children from before birth until the age of 21 by collecting detailed data, biological specimens such as blood and urine, and environmental samples, including dust from childhood homes. In 2000, Congress authorized the National Institutes of Health (NIH) to go ahead with the project, which would be called the National Children's Study.

In the 14 subsequent years, the government has spent $1.3 billion, working with hundreds of scientists at dozens of sites around the country. There's little to show for the effort. While some 5,700 children have been enrolled in pilot studies since 2009, researchers stopped collecting data on Dec. 12, when the NIH concluded that the project could not be salvaged and moved to shut it down. Families that had signed up received letters saying their contributions would no longer be needed.

"The goals of the study were laudable and they remain laudable," Francis Collins, NIH director, says. "Most of us believe it should now be possible to accomplish those goals at a substantially lower cost and higher efficiency."

How did the plan to track a generation of children unravel? There’s no single answer, according to interviews with more than half a dozen researchers and officials involved in the project, along with a review of public documents. A few explanations stand out. Science and technology overtook the study's designers, who weren't able to incorporate developments such as social media or data collection using mobile devices into their plans, Collins says. Funding for the full study was delayed for years as researchers argued over its design. Early estimates low-balled cost, leading to finger-pointing that threw the study into turmoil. And a toxic rift between NIH administrators and scientists at the 40 universities and hospitals conducting the study undermined the project.

Additional tensions strained the National Children’s Study from inception. Debates over how to recruit women early in pregnancy—or even before conception—carried on for years. The initial approach—to reach potential participants in select neighborhoods by knocking on doors—proved difficult and costly, compared to enrolling women through their doctors or at hospitals. Researchers also went back and forth as to whether the investigation should begin with clearly articulated hypotheses or serve as a broader “platform study” that collected data for future scientific inquiries. The risk with the latter approach, scientists warned, was that crucial measurements would be omitted because investigators didn’t plan which questions to answer ahead of time.

NIH Director Francis Collins.