NEWS OF THE W EEK
PUBLISHING: Researchers, journals consider federal request to censor recipe for contagious flu
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WO INDEPENDENT research teams have de-
veloped strains of avian influenza so potentially deadly that they’ve prompted an unprecedented response from the U.S. government. A federal advisory board has asked the journals Science and Nature not to publish details of the teams’ controversial research, so as to hide it from would-be bioterrorists. In the not-yet-published work, scientists at the University of Wisconsin, Madison, and Erasmus Medical Center, in Rotterdam, the Netherlands, reportedly made mutant versions of the H5N1 avian flu virus that are highly contagious among ferrets, the lab animal that is most like humans in flu susceptibility. More than half of the people infected with real-world variants of H5N1 have died from it, but those viruses didn’t spread from person to person easily. The new lab-made viruses were created as part of efforts to develop drugs or vaccines to stop pandemics, the researchers say. But if the viruses fell into the wrong hands, they could touch off the very pandemics they were created to prevent. After a lengthy review of both teams’ manuscripts, the U.S. National Science Advisory Board for Biosecurity, which is overseen by the National Institutes of Health, asked the journals to redact mutation details that might allow the results to be replicated. The board also requested additions, including explanations of biosecurity practices and the research’s potential benefits to public health. The Dutch virologists, led by Ron Fouchier, “have
reservations about this recommendation but will observe it,” according to a statement from Erasmus Medical Center. At this point, however, secrecy “is almost impossible” because many flu scientists and officials have already seen the details, the statement points out. Asked whether Wisconsin virologist Yoshihiro Kawaoka and coworkers would also redact portions of their work, university spokesman Terry Devitt said that hasn’t been determined yet. But “the recommendations, which are nonbinding, are being seriously considered” as the team prepares a revised manuscript, Devitt added. Both Science and Nature have professed their willingness to work with the board, given certain conditions. Science’s response, Editor-in-Chief Bruce M. Alberts said in a statement, will be “heavily dependent” on the government putting forth a transparent plan that ensures legitimate scientists can access the censored information. Nature Editor-in-Chief Philip Campbell concurred, saying in a statement that access for researchers “is essential for public health.” Plans for a system permitting such access are in the works, according to a statement from NIH. The statement provides no details, however, about how the system would run and who would be qualified to use it. Both journals are discussing those points with the board. “It is a complicated matter,” says Ginger Pinholster, a spokeswoman for Science. “We have been grateful to talk in depth with officials about how the information transfer can be achieved.”—CARMEN DRAHL CY N T HIA GO L DSM IT H/CDC
BIRD FLU STUDIES STIR CONTROVERSY
Government officials want to keep the recipe for a contagious version of H5N1 flu under wraps. In a colorized TEM image, H5N1 (gold) grows among kidney cells (green). Virus particles are typically 80–120 nm in diameter.
DRUG SAFETY India’s Ranbaxy reaches agreement with the Food & Drug Administration Ranbaxy Laboratories, a subsidiary of Japan’s Daiichi Sankyo, has settled with FDA over the agency’s critical assessment of two of its generic drug plants in India. Ranbaxy has signed a consent decree committing it to rectify poor manufacturing practices at the two plants. The company has also set aside $500 million to cover civil and criminal liabilities associated with a related investigation by the U.S. Department of Justice. In 2008, FDA found Ranbaxy’s facilities in Paonta Sahib and Dewas, India, not in compliance with current Good Manufacturing Practices, a set of standards that
firms selling drugs in the U.S. must follow. FDA blocked imports from the plants, although it did not find evidence that the Indian firm had shipped defective products. The signing of the consent decree should allow Ranbaxy to resume U.S. exports of products made at the facilities, provided that the firm complies with the terms. In the 12 months to Sept. 30, 2011, Ranbaxy’s sales in the U.S. were $334 million, a third less than a year earlier. Daiichi Sankyo, which owns about 60% of Ranbaxy, issued a profit warning as a result of the $500 million provision. Yet investors and financial analysts
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seem willing to put the matter behind them. On Dec. 22, 2011, the day after the announcement of the consent decree, Daiichi’s stock opened higher in Tokyo before settling unchanged from the day before. Ranbaxy’s stock, listed on the National Stock Exchange of India, closed slightly higher on the same day. Also after the news, Naomi Kumagai, a stock analyst with the investment firm Jefferies, reaffirmed her recommendation to buy Daiichi’s stock. According to market rumors, she noted, Ranbaxy was going to have to pay as much as $1 billion to U.S. authorities.—JEAN-FRANÇOIS TREMBLAY
