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...Food and Drug Administration is also handcuffed. Most of the ADHD ads are not within its jurisdiction because they neither name the drug nor describe it. (Exception: Celltech's ad for Metadate CD, which the FDA is reviewing.) And even if they were, says FDA official Nancy Ostrove, the agency doesn't have the authority "to treat advertisements for controlled substances any differently" from those for other drugs. As for the drug companies, they insist their ads "are within the letter and spirit of all laws," in the words of a spokesman for McNeil...
Ritalin, the first of the methylphenidates to be approved, works for three to four hours and requires two to three doses a day. The newest generation of drugs in this class does better: Novartis, Ritalin's maker, is waiting to hear whether the FDA will approve its new version, Ritalin LA, which has double the current drug's effective time. Concerta, available since last summer, is effective for 12 hours; Metadate, approved in 1999, lasts about eight hours. A Concerta capsule acts as a minipump, gradually pushing methylphenidate out through tiny, laser-drilled holes in its coating. With Metadate, about...
Scientists are still debating whether that is the case. When the FDA approved the COX-2 inhibitors, it required Merck, the manufacturer of Vioxx, and Pharmacia, which markets Celebrex jointly with Pfizer, to include warnings about potential gastrointestinal problems...
Merck and Pharmacia were convinced that their medications had a better side-effect profile and submitted additional data to an FDA advisory panel last February. But the extra information raised new red flags for Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who was consulted by the FDA. Nissen noticed what seemed like a high number of heart attacks and other cardiovascular problems in the companies' data. Together with Dr. Eric Topol and Dr. Debabrata Mukherjee, Nissen decided to look into the matter further...
...human stem cells, and only those colonies, hit a serious snag last week with the revelation that virtually all stem cells are cultivated using embryonic mouse tissue. The mouse cells provide the human ones with nutrients and growth factors crucial to their survival and proliferation. The problem: under FDA rules, mouse-fed stem cells given to treat human patients would be considered a "xenotransplant," or tissue from another species. Although hundreds of patients have received liver and fetal cells from pigs without any sign of foreign infection, the agency could halt a stem-cell procedure if it felt the human...