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Oraflex's troubles began in 1980, when it was marketed in the United Kingdom and eight other countries and submitted to the Food and Drug Administration for approval. The medicine received the FDA stamp in April 1982. Federal investigators maintain that Oraflex was a factor in the deaths of more than 100 people, including at least 26 in the U.S., between the time it first went on sale and August 1982, when it was removed from American store shelves...
...controversy over saccharin, which is produced by Cleveland-based Sherwin-Williams, began in 1977, when the Food and Drug Administration linked extremely large doses of the artificial sweetener to bladder cancer in laboratory animals. As a result, the FDA proposed that the use of saccharin be outlawed. Congress thwarted the agency's move by giving the product an exemption from a federal law that prohibits the sale of any substance found to cause cancer in animals or humans. That reprieve ran out last month...
...patient's family to try an artificial heart. He called Heart Surgeon Cecil Vaughn of St. Luke's Hospital in Phoenix, who for two years has been experimenting with the "Phoenix heart," the invention of Kevin Cheng, a dental surgeon. Vaughn was stunned; the heart was years away from FDA approval and had been tested only twice in animals. "It was like a bomb falling from the sky," he recalls. Still he agreed to helicopter to Tucson immediately with Cheng and his invention...
...tested the Jarvik-7 heart, which sustained Barney Clark for 112 days and was, at week's end, still beating in William Schroeder and Murray Haydon at the Humana Hospital in Louisville. Although Olsen was well aware that famed Surgeon William DeVries is the only doctor authorized by the FDA to implant the Jarvik-7, he agreed to fly to Tucson with the device. Said he: "In critical situations like this, we have to respond...
...could," Copeland told reporters after the death. "As a physician, my conscience is clear." Though the FDA initially expressed disapproval of Copeland's actions and has demanded a written explanation, the agency said at week's end that it did not "contemplate any drastic penalty" for the surgeon or his hospital...