By Eugenie Samuel Reich of Nature magazine
When Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, overruled the Food and Drug Administration (FDA) on December 7 and denied over-the-counter access to the Plan B One-Step "morning-after" pill for girls aged under 17, advocates for scientific integrity in government were outraged. Although the FDA's decision to allow access had been based on an in-depth scientific review, Sebelius--who is not a scientist by training--claimed that the data did not support the view that young girls would be able to use the drug safely. "The key problem is she re-reviewed the science,: says Francesca Grifo of the Union of Concerned Scientists in Washington, D.C.
It is no small irony that a row over political interference in scientific decision-making should erupt just as President Barack Obama's initiative to shield government scientists from such pressures comes to fruition. Agencies and departments across the U.S. government have been working to submit final drafts of scientific-integrity policies, many of which make some reference to disallowing politically motivated alteration of data.
The policies were due to be submitted to the government's Office of Science and Technology Policy (OSTP), where its director John Holdren is overseeing the process, by December 17. Last week, Nature conducted its own survey of the effort by contacting agencies directly. Of the 11 departments and agencies that have confirmed to Nature that they are drafting new policies, six now have public policies that make some reference to forbidding politically motivated alteration of data. A seventh, the Department of Justice, has told Nature that a working draft does so.
But three agencies--the Department of Health and Human Services, the Department of Energy and the Department of Defense--have not made their policies public or answered Nature's questions about them. A fourth agency--the National Institute of Standards and Technology (NIST)--has no public policy but has told Nature that a working draft does not explicitly ban political alteration of data. Henry Wixon, the chief counsel for NIST, says that this has not traditionally been an issue at the agency, but adds that he may consider amending the NIST draft policy. Similar shifts have taken place at NASA and the National Science Foundation, both of which included language banning political interference in the latest versions of their integrity policies, released in the past week. Earlier drafts did not include such language.
The stakes are highest at regulatory agencies where science directly informs policy. Among these, the Environmental Protection Agency has moved forward with asserting that the work of its scientists and engineers should be free from political influence. However, critics have complained that the agency's draft policy could be clearer about the fact that the requirement applies to agency political appointees, not just to scientists employed by it. Another regulatory agency, the energy department, received a letter on December 15 from the Project on Government Oversight, a watchdog group based in Washington, D.C., calling for its policy to include an independent oversight mechanism for breaches of research ethics.
Yet some question whether the integrity policies go far enough. It is far from clear, for example, whether such a policy at the Department of Health and Human Services would have prevented the furor over Plan B.
Nick Steneck, a research ethicist at the University of Michigan in Ann Arbor, says that the OSTP should offer stronger leadership to make it clear that integrity policies must address political interference. "Issuing a simple document is not sufficient," he says.
This article is reproduced with permission from the magazine Nature. The article was first published on December 20 2011.