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...Food and Drug Administration--news that the company made public after the markets closed on Dec. 28. He is also accused of tipping off his daughter Aliza, who sold $2.5 million of ImClone, and his father Jack, who sold $6.7 million of the stock ahead of the FDA news. Only Waksal has been charged; he denies wrongdoing...
...FDA, which in April approved botox injections for wrinkle removal only, has not yet endorsed botox as a treatment for migraines--although doctors are able to administer it to patients "off label." The treatments are neither easy nor cheap. They involve 30 or 40 injections around the head, temple, jaw, neck and shoulders, cost $1,000 or more and wear off after three or four months. Some patients will still prefer less invasive preventive measures, such as getting plenty of sleep and cutting back on red wine, chocolate and aged cheeses...
...More than 80% of U.S. women have an annual Pap test, but fewer than 20% are screened for chlamydia, a sexually transmitted disease (STD) that, left untreated, can lead to pelvic inflammatory disease and reproductive complications. Now the FDA has approved a popular Pap test, ThinPrep, to screen for both cervical cancer and chlamydia, the most common bacterial STD in the U.S. today. --By David Bjerklie...
...Erbitux controversy raised questions at last week's congressional hearings on ImClone as to whether FDA protocol encourages insider trading. But agency officials contend that frequent communication with applicants is essential. "If a sponsor chooses to act on that information and insider trade, that's his responsibility," says Robert Temple, director of the FDA's oncology-drug evaluation group. And last week, without naming names, Treasury Secretary Paul O'Neill suggested a solution to the escalating crisis of executives abusing trust. "We ought to hang them from the very highest branches." --With reporting by Andrew Goldstein/Washington and Unmesh Kher...
Twenty years later, Mendelsohn is president of MD Anderson Cancer Center in Houston, and his cancer-fighting approach remains controversial. When his backers at ImClone sought FDA approval for Mendelsohn's Erbitux cancer drug, the agency declined to consider it. By giving cancer patients Erbitux and chemotherapy together in clinical trials, the FDA said, ImClone made it difficult to determine how much impact Erbitux...