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Adviser to National Children’s Study quits

An environmental scientist at Johns Hopkins University in Baltimore, Maryland, has resigned from the expert advisory committee intended to guide the US National Children’s Study (NCS), charging that the goals of the massive study, which aims to track factors affecting the health of 100,000 children from before birth to age 21, have been “significantly abrogated” by its managers at the National Institutes of Health (NIH).

In an e-mail this morning to study director Steven Hirschfeld, Ellen Silbergeld said that the study’s just-announced change away from representative sampling of 100,000 US children means that it “will no longer provide representative information of value to practitioners, researchers and the public.”

Silbergeld, a professor of environmental health sciences with joint appointments in epidemiology and in health policy and management at the Johns Hopkins Bloomberg School of Public Health, added that the shift away from population-based sampling that delivers generalizable results “is a great disappointment and places the US study in a poor light in comparison to other national and international projects”.

Silbergeld’s e-mail can be read in its entirety here.

The decision by those managing the study at NIH’s National Institute of Child Health and Human Development (NICHD), was detailed last month in this report from the agency to Congress (see pages 34 and 35) and first reported publicly in this Nature news story. In essence, the study managers hope to conserve costs and markedly increase recruiting efficiency by enlisting pregnant women in the offices of physicians and other health-care providers rather than going door-to-door in neighborhoods.  (It’s worth noting that some principal investigators on the study feel passionately that representative sampling does not have to be given up with this change, because the vast majority of pregnant women ultimately seek prenatal care in health providers’ offices.)

Silbergeld also complained today in a telephone interview that Hirschfeld and his boss, Alan Guttmacher, the director of NICHD, have sidelined the NCS Federal Advisory Committee, which she joined a year ago.  She said that the committee, despite asking to be actively involved in shaping the study, has been placed in a passive role in which they are informed of key decisions rather than advising on them.  Nonetheless, she claims, Hirschfeld regularly presents those decisions publicly as having been “vetted” by the committee.

Other committee members clearly share her concerns. A working group of the Advisory Committee presented these slides to Guttmacher and Hirschfeld at the committee’s most recent meeting in late January.

“Too little time devoted to dialogue during meetings”, read one.  “Too many presentations where [advisory committee] members are observers.”  Among their requested changes: “Allow the [committee] to debate and make formal recommendation[s].”

In response to similar complaints from an unnamed advisory-committee member, Guttmacher said in an interview with Nature last month:  “We clearly value the input of the advisory committee and have had discussions with them about how to optimize that…. As with any advisory committee, they are there to give us advice. There are some decisions at the end of the day we need to make.”

The National Children’s Study was launched in 2009 after years of preparation, but has struggled to recruit adequate numbers of children and to keep costs in control.  Last month, the White House proposed cutting its budget by 15% in 2013, to US$165 million — a cut that requires Congressional approval in the coming months.

Support from Congress is important at this juncture.  Politicians on Capitol Hill, who have generally been passionately in favour of the study, lost patience in 2009, when study managers failed to notify them that the study’s costs could escalate to $6 billion, twice its advertised price.  Its then director, along with the NICHD director at the time, were removed.  See this Nature news story for that piece of NCS history.

In another controversial move, the study’s managers are intending to replace the principal investigators who run several of the study’s pilot-phase, ‘Vanguard’ sites with a single contractor, according to this Science story published last week.

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