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...more than a little disturbing last week when the Food and Drug Administration announced it was shutting down part of the facilities at CryoLife Inc., a leading supplier of donated tissue in the U.S. The FDA charged that a number of the implants, which are processed (in the industry euphemism) from dead bodies and stored in tissue banks, had not been properly handled, leading to serious infections in at least 26 patients. The agency recalled tendons, ligaments and cartilage distributed by the Georgia-based company since October...
Oversight of the tissue industry is spotty. At the state level, only Florida and New York require licensing and inspection of tissue banks. At the federal level, a 2001 report found that the FDA did not know how many tissue banks were operating and had never inspected 20% of the 154 facilities identified. But eventually the FDA, with help from the Centers for Disease Control and Prevention, zeroed in on CryoLife. Together the agencies charge that on at least one occasion CryoLife improperly distributed tissue from a cadaver it had learned was contaminated. (CryoLife could not confirm or deny that...
...into the troubled biotech firm ImClone in June, they had a simple but explosive question for Martha Stewart, a friend of former ImClone CEO Samuel Waksal's: Did she receive inside information that prompted her to sell her ImClone stock just a day before the Food and Drug Administration (FDA) rejected ImClone's cancer drug and sent the share price tumbling...
...committee disclosed more information last week, deepening suspicions that Bacanovic, who was also Waksal's broker, had advance knowledge of the FDA rejection. In a Dec. 27 e-mail sent to his assistant before the Stewart sale, Bacanovic asked, "Has news come out yet? Let me know, thx, P." The assistant replied, "Nothing yet. I'll let you know. No call from Martha, either." The FDA rejection was announced after the market close on Dec. 28. Bacanovic's assistant, Douglas Faneuil, at first backed Stewart's story. But published reports say he later recanted, telling prosecutors that Bacanovic prompted...
HOLD THE TUNA An FDA advisory panel has urged the agency to warn pregnant women to limit the amount of canned tuna they eat because it contains mercury, which can harm the nervous system of an unborn child. (Last year the FDA advised pregnant women not to eat shark, swordfish, king mackerel or tilefish, but it did not include tuna on the list.) Health officials say there is no need for women to cut out tuna entirely but advise that it may be prudent to limit consumption to one can a week if they eat other fish...