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FDA employees sue agency over email surveillance

Six former and current scientists at the US Food and Drug Administration (FDA) have sued the agency for secretly monitoring their personal e-mail, according to the Washington Post.

The suit, filed on 25 January 2012, claims the FDA monitored the computers of several employees in the Center for Devices and Radiological Health (CDRH). All are scientists or doctors who had  contacted members of Congress or the White House over concerns that the agency was approving devices such as cancer-detecting tools they believed to be dangerous and/or ineffectual for patients. The CDRH oversees the performance and safety of medical devices.

The suit asserts that the FDA (and the government as a whole) violated the scientists’ rights to due process and free speech and violated the public’s right to associate with whistleblowers.

According to a release by the law firm representing the group, the FDA targeted the employees with a “covert spying campaign” that lasted for two years after it learned they had written a letter to president-elect Barack Obama in early 2009.  The 7 January 2009 letter claims the “scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers,” and describes a “hostile working environment” and “disregard for federal violations.”

The letter also specifically called out breast-cancer detection devices that were approved by the FDA even though there was no clinical evidence to support their efficacy. Research after approval showed that the devices did not improve screening and led to unnecessary breast biopsies.

The plaintiffs allege the agency used spyware to read the their personal e-mails and take screenshots while they used government computers. But whether such reconnaissance is illegal is not quite clear. According to the Washington Post, “the startup screen on FDA computers warns employees, ‘you have no reasonable expectation of privacy,’ including any communication accessed or sent from the machine.”

According to the law firm representing the plaintiffs, the monitoring continued even after the Health and Human Services Office of Inspector General “denied the FDA’s request to take any criminal and/or administrative action against the whistleblowers” and noted that the whistleblowers’ communications with Congress were protected under law.

According to the suit, the FDA did not renew the contract of one of the whistleblowers, who had previously received exemplary reviews, because of his disclosures about the safety and efficacy of a colon-cancer detecting device. Another positively-reviewed scientist may have been terminated at least in part over his e-mail correspondence with Congress about concerns over the safety and effectiveness of a mammography device.  Other whistleblowers were reprimanded and threatened with disciplinary action because of their electronic communications.

“To the degree to which an agency attempts to impede the ability of federal officials to petition Congress, that is illegal,” says Paul Thacker, chief of investigations at the electoral-reform advocacy group United Republic and former medical-corruption investigator for U.S. Senator Charles Grassley.

The suit may raise questions about the FDA’s commitment to sound science and openness, a cause that current director Margaret Hamburg has publicly championed.   Although the surveillance began before Hamburg took up the role in May 2009,  it continued well after she was appointed.

The efforts of employees in any agency to try to get members of Congress to focus on issues that they believe the agency is not properly addressing are “one of the more important sources of information for Congressional committees”, says Sidney Wolfe of the Health Research Group at Washington-based Public Citizen. “A number of Congressional hearings over the years in both the House and the Senate that have been held purely as a result of information that was provided by whistleblowers in agencies”.

The FDA has told Nature it does not comment on pending or ongoing litigation.

Credit: National Institutes of Health

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