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A lack of integrity

The US government is at last making progress in its efforts to protect scientific integrity, but claims of harassment of whistle-blowers suggest that more than just internal departmental policies will be needed. Rebecca Trager reports.

The White House may have jumped the gun when it announced in December that it had made headway in getting federal agencies to develop policies to ensure scientific integrity. A lawsuit brought against the US Food and Drug Administration by six current and former scientists suggests that preserving agencies’ integrity requires more than internal “paper” policies.

After George W Bush’s administration was accused of manipulating science for political purposes, Barack Obama’s 2008 campaign focused on scientific integrity. On taking office, Obama promised to “restore science to its rightful place”. That message resulted in a memo on scientific integrity in March 2009, and a May 2010 directive requiring each agency develop a policy in this area.

Although draft policies were due by summer 2010, 19 federal agencies and departments did not submit advanced drafts until the end of 2011. Despite the delay, the White House science adviser John Holdren wrote in a 21 December blog post that the Obama administration is “firmly committed to the highest standards of scientific integrity.”

Among those that missed the deadline was the Department of Health and Human Services, which is responsible for agencies such as the FDA and the National Institutes of Health.

Last month, Francesca Grifo, director of the Union of Concerned Scientists’ scientific integrity programme, told President Obama’s Council of Advisors on Science and Technology that the HHS has been “relatively uncommunicative and has not released any draft policy”. This apparent inaction is surprising considering the prominence of the department’s agencies.

Also surprising is that one crucial ingredient to maintaining scientific integrity across government seems to have been downplayed: the need to protect scientists who risk their careers by becoming whistle-blowers.

In their lawsuit against the FDA, filed on 25 January, the plaintiffs, who have all been involved in the agency’s safety-review process, claim that they were targeted after expressing concerns about the safety of medical devices that were being approved.

Specifically, they accuse the FDA of spying on them for two years after discovering that they had complained to Obama and lawmakers on congressional oversight committees about the approval of unsafe devices. Court documents suggest that the agency used spyware to investigate workplace computers. The plaintiffs also allege that FDA officials intercepted emails to and from staffers on the House and Senate oversight committees.

It seems that the FDA continued its monitoring even after the HHS Office of Inspector General refused its request to take criminal or administrative action against the six employees in May 2010.

Two of the plaintiffs were fired and the contracts another two were not renewed, according to their attorney. The final two are still employed at FDA, where they claim that harassment continues.

The controversy has now spurred investigations in both chambers of Congress.

Chuck Grassley, a republican senator from Iowa who sits on the Senate Judiciary Committee, wrote to FDA commissioner Margaret Hamburg asking that she provide him with details about the case by 17 February. Meanwhile, representative Darrell Issa of the House Oversight and Government Reform Committee, launched his own probe. In a 9 February letter to Hamburg, Issa said that interference with an employee’s right to provide information to Congress is “unlawful and will not be tolerated”. Hamburg was given until 21 February to respond to Issa’s request for additional information.

During a 15 February Senate hearing, HHS secretary Kathleen Sebelius said she shares concerns about retaliation against whistle-blowers,but added that the FDA needs to guard against the release of proprietary information that could disadvantage companies.

Paper policies are generally too weak to protect the independence of staff at federal agencies. A rising chorus of voices is calling for new statutes. In particular, some propose that government should prohibit agencies from targeting whistle-blower scientists for surveillance.

As the presidential election campaign gathers pace, Obama is under pressure to show his commitment to scientific integrity with something stronger than words.