Pharmacy shipped drug linked to meningitis outbreak without waiting for sterility test results, investigators report. Although the New England Compounding Center’s records indicate the tests found no contamination, Massachusetts regulators expressed skepticism. The official overseeing Massachusetts’ health department investigation said documents suggest that the company failed to sterilize products for “even the minimum amount of time necessary to ensure sterility.” State investigators also found that the pharmacy failed to keep its manufacturing equipment sanitary and operated a leaky boiler near the “clean room.” So far, 304 people in 17 states have contracted meningitis, and 23 have died. The New York Times, The Wall Street Journal
Europe’s drug regulator launches probe into Roche’s alleged failure to report potential side effects. If found at fault, the Swiss company — the world’s top maker of cancer medicines — could be fined up to about $690 million. It is first time the European Medicines Agency has launched such an “infringement procedure” since it gained the powers to do so five years ago. The agency will report its findings to the European Commission, which may impose penalties “if it finds that Roche has committed an infringement of its obligations,” the agency said. The issue of safety reporting by Roche was highlighted in June after a routine British inspection found the company had failed to fully assess up to 80,000 cases of possible adverse drug reactions. There were some 15,000 deaths among the reports, although the fatalities weren’t necessarily due to the drugs. Reuters, Medical News Today
Study will examine cancer risks for people living near nuclear power plants. The U.S. Nuclear Regulatory Commission study will focus on the areas within a 30-mile radius of six plants, including the out-of-commission San Onofre operation in north San Diego County. The NRC is acting out of growing concern that using uranium to produce electricity may be dangerous even without accidents at nuclear plants. In addition, recent epidemiological studies in Germany and France suggest that children living near nuclear reactors are twice as likely to develop leukemia. U.S. authorities last assessed cancer rates near nuclear power plants in 1990 and concluded that the health risks, if any, were too small to be measured. Los Angeles Times
Regulator calls automated cars next “evolutionary step” in vehicle safety. David Strickland, head of the National Highway Traffic Safety Administration, noted that human error was a factor in about 90 percent of the 33,000-plus traffic deaths in 2010. As a result, Strickland said, “We have the chance of … saving thousands and thousands of lives” by replacing current cars with automated vehicles. He said regulators have begun a study, which will take up to three years, to develop national standards for the technologies. Already, Google is developing a fleet of automated vehicles, and auto manufacturers are following suit. California, Florida and Nevada have authorized testing automated cars on their roads. The Associated Press, Inside Line
European Union corruption probe investigates $78.3 million payment requested from tobacco lobbyist. Sources familiar with the investigation say the ousted European Health Commissioner John Dalli met with his political associate Silvio Zammit immediately before Zammit first requested the payment from the tobacco lobbyist. The alleged request for money during a Feb. 10 meeting in Malta—in return for a change in tobacco legislation—sparked a probe by the European Union’s antifraud office and Dalli’s departure last week. Zammit allegedly said Dalli would pull back on legislation banning in most EU nations the sale and export of snus, a smokeless-tobacco product, in exchange for the payoff. The Wall Street Journal
Compiled by Stuart Silverstein
