Report Finds Drug Companies Aren’t Providing Key Information to U.S. Regulators About Risky Medicines

Assessment suggests that pharmaceutical companies are ignoring requirements to manage safety of high-risk drugs. The report from the Department of Health and Human Services’ inspector general is the first independent review of a program designed to give the Food and Drug Administration more control over certain risky drugs. Beginning in 2008, the regulators gained the power to require manufacturers to develop plans — known as Risk Evaluation and Mitigation Strategies, or REMS — for how doctors use the drugs. The plans might, for example, call for pregnancy testing before woman can use a medicine linked to birth defects. But the report faulted drug companies and the FDA for failing to track the use of the drugs. The Associated Press, Forbes

Life-threatening drug reaction leads to $63 million against Johnson & Johnson. A state court jury awarded the money to a Plymouth, Mass., family whose daughter, then 7, suffered a reaction 10 years ago to Children’s Motrin, a version of ibuprofen made by Johnson & Johnson. The child was given the pain reliever after showing signs of fever. But after continuing to take the drug, she developed blisters and fatigue — and the condition only grew worse. Within days, it was diagnosed as Toxic Epidermal Necrolysis, a rare reaction to some medications, including ibuprofen. “It’s like having your skin burned off of you,” said one of the family’s lawyers. J&J said it disagreed with the verdict and is considering legal options. The Boston Globe, The Associated Press

Suicides dominate U.S. gun deaths. The latest figures, for 2010, show that nearly 20,000 of the 30,000 U.S. deaths from guns were suicides, and the suicide rate has climbed 12 percent since 2003. Guns — as opposed to, say, pills — are particularly lethal in suicide attempts. Wyoming, Montana and Alaska, the states with the highest suicide rates, are also the top gun-owning states, Harvard researchers say. “The literature suggests that having a gun in your home to protect your family is like bringing a time bomb into your house,” said a federal epidemiologist. “Instead of protecting you, it’s more likely to blow up.” But some dispute the link, saying alcoholism, drug abuse and personal qualities may make gun owners more susceptible to suicide. The New York Times

U.S. authorities warn of “ongoing, severe epidemic” of sexually transmitted infections. The Centers for Disease Control and Prevention said 20 million new cases emerge every year of the easily preventable diseases. The economic toll is $16 billion annually, as many people do not get tested and their infections can lead to complications. HPV, the Human Papilloma Virus, accounts for 14 million of the new infections annually. Although 90 percent of HPV infections go away in two years, vaccination is suggested for 11- and 12-year-old boys. “All STIs are preventable. They’re all treatable, and many are curable. But if they’re left untreated, they can lead to pretty serious lifelong problems and even death,” said a CDC epidemiologist. Medical Daily

Team of scientists proposes reclassifying harmful plastic wastes as hazardous material. That switch, the scientists wrote in the journal Nature, could trigger changes in how governments clean up plastic waste and spur the replacement of problematic plastics with safer ones. The U.S., Europe, Japan and other nations treat the disposal of plastics much like food scraps or grass clippings, said coauthor Mark Anthony Browne. It’s a view that, he said, ignores evidence that plastic debris is laden with highly toxic pollutants. The authors modeled their proposal after the landmark 1989 pact that classified refrigerants known as CFCs as hazardous. Production of CFCs, which were burning a hole in the atmosphere’s ozone layer, stopped in seven years. Los Angeles Times

Compiled by Stuart Silverstein

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