Scandals, recalls, stingy customers, anxious regulators--any one of these would traumatise a chief executive. America's industry for medical devices is suffering from all of them. Omar Ishrak, the new boss of Medtronic, the world's biggest medical-technology company, recently described the problem succinctly to analysts: "There is a lot of work ahead of us." This is a relatively new ailment for the industry. From 1998 to 2005 the use of equipment such as defibrillators and drug-eluting stents expanded rapidly. "It was the age of implantation in this country," explains David Lewis of Morgan Stanley, with companies "sticking things into everybody." Much has changed.
Anel Potti, Joseph Nevins and their colleagues at Duke University in Durham, North Carolina, garnered widespread attention in 2006. They reported in the New England Journal of Medicine that they could predict the course of a patient's lung cancer using devices called expression arrays, which log the activity patterns of thousands of genes in a sample of tissue as a colourful picture. A few months later, they wrote in Nature Medicine that they had developed a similar technique which used gene expression in laboratory cultures of cancer cells, known as cell lines, to predict which chemotherapy would be most effective for an individual patient suffering from lung, breast or ovarian cancer. At the time, this work looked like a tremendous advance for personalised medicine--the idea that understanding the molecular specifics of an individual's illness will lead to a tailored treatment.
Food and Drug Administration advisers voted Friday to require makers of widely used osteoporosis drugs to clarify how long patients should take them for the greatest benefit and least risk. The FDA itself will later decide what the new label wording should say for each of the drugs: Fosamax, Boniva, Actonel, Atelvia and Reclast. The agency could require wording that recommends limiting how long each drug is taken, though it's not yet clear how long that would be. A few patients have suffered serious complications, including jawbone destruction, unusual thighbone fractures and cancer of the esophagus, generally after several years taking the medicines, which include pills and longer-acting intravenous treatments.
For six months, the remains of the hospital in Rikuzentakata have stood empty--wind blowing through the tsunami-smashed rooms where this city's sick once sought care. Dr. Mikihito Ishiki, chief of medicine, is fighting to rebuild his hospital.
A medical privacy breach led to the public posting on a commercial Web site of data for 20,000 emergency room patients at Stanford Hospital in Palo Alto, Calif., including names and diagnosis codes, the hospital has confirmed. The information stayed online for nearly a year. Since discovering the breach last month, the hospital has been investigating how a detailed spreadsheet made its way from one of its vendors, a billing contractor identified as Multi-Specialty Collection Services, to a Web site called Student of Fortune, which allows students to solicit paid assistance with their schoolwork. Gary Migdol, a spokesman for Stanford Hospital and Clinics, said the spreadsheet first appeared on the site on Sept. 9, 2010, as an attachment to a question about how to convert the data into a bar graph.
In the dark and uncertain days after Sept. 11, 2001, the sight of thousands of shaken New Yorkers returning to their apartments, offices and schools in Lower Manhattan seemed to signal a larger return to normalcy. Now new documents have emerged showing that federal officials in Washington and New York went further than was previously known to downplay concerns about health risks, misrepresenting or concealing information that ultimately might have protected thousands of people from the contaminated air at ground zero. The documents do not reveal how—or whether—federal officials explicitly weighed the competing goals of ensuring New Yorkers' safety and projecting an image of a city and nation unbowed. But taken as a whole, the records—which include email messages from the White House's Council on Environmental Quality to the Environmental Protection Agency and the Occupational Safety and Health Administration, as well as interagency correspondence—give the most detailed account yet of how officials kept potentially disturbing data about health risks from the public.