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

Voters in the state of Mississippi have decided that a fertilized egg should not be given the legal rights and privileges of an infant or adult human.

With two-thirds of precincts reporting following today’s state-wide election, it seems that the vote is about 57% against Initiative 26 — a ballot measure that proposes to amend the state’s constitution to redefine ‘person’ as “every human being from the moment of fertilization, cloning, or the equivalent thereof”.

Such an amendment would have criminalized abortion in the state in most, if not all, circumstances. Some opponents of the initiative were also concerned about its implications for in vitro fertilization (IVF), some forms of birth control, and for human embryonic-stem-cell research (see Mississippi to vote on ‘personhood’ ).

“We’re proud that the people of Mississippi looked at the facts and made the decision that this is a dangerous and extreme government intrusion into people’s lives,” Stan Flint, a consultant for Mississippians for Healthy Families, based in Jackson, told Nature.

The 8 November election is the third time a personhood amendment has gone to the polls in the United States. In 2008 and 2010, similar initiatives were voted on in Colorado and neither passed. The amendments earned, respectively, 27% and 29% of the vote. Although Initiative 26 was unsuccessful, it looks to have earned a higher percentage of ‘yes’ votes than any similar measure. This could boost efforts to get personhood amendments on the ballot in several more states for elections in November 2012.

An AIDS-free generation is possible if the world makes the most of proven preventive interventions, said US Secretary of State Hillary Clinton on 8 November at the National Institutes of Health (NIH) in Bethesda, Maryland.

Clinton announced that the US government will now commit an additional US$60 million to scale up combination prevention efforts in sub-Saharan Africa and “rigorously measure the impact.” The AIDS pandemic is most severe in sub-Saharan Africa, where 70% of AIDS-related deaths occur.

In 2010, the United States spent almost $7 billion in the fight against HIV/AIDS and associated diseases such as tuberculosis. The funding announced today will help researchers determine how well the combination prevention efforts work towards eliminating AIDS in different settings.

“Creating an AIDS-free generation has never been a policy priority for the United States government until today because this goal would have been unimaginable just a few years ago,” she said before an auditorium filled with members of the NIH community, HIV/AIDS advocates, domestic and foreign dignitaries and US government officials.

Building on the efforts of policy-makers and scientists in the United States, the world can “usher in an AIDS-free generation” by focusing on the combination of three proven strategies: ending mother-to-child transmission, expanding voluntary medical male circumcision, and scaling up treatment for people living with HIV/AIDS.

Mother-to-child transmission accounts for 1 in 7 new HIV infections. The transmission can be prevented with anti-retroviral therapies and safe birth and feeding practices. Last year, the President’s Emergency Plan for AIDS Relief (PEPFAR) helped prevent infection in some 114,000 babies, and PEPFAR and the United Nations Programme on HIV/AIDS (UNAIDS) have since launched a global plan to eliminate all new infections in children by 2015.

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