Word: panels
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Dates: during 1990-1999
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...just another way to die. Yet that's the depressing possibility the Food and Drug Administration was forced to confront last week. At least 35 people have died from liver damage after taking Rezulin, a medication the agency approved two years ago. In an unusual meeting last week, a panel of independent experts wrestled with the question of whether the agency should reverse itself and pull the drug from the market...
...panel said Rezulin should stay in circulation: the dangers are real, but they're outweighed by the drug's lifesaving potential. But even if the FDA goes along with the decision--which it need not but generally does--the very fact that the meeting took place raised questions about the agency's approval process. Rezulin got its thumbs-up via the so-called fast-track system, which slashes through some of the FDA's red tape in order to get an important medication into patients' hands quickly. Drug companies love it, since it gets profits rolling in sooner...
...fast track cuts back on not just bureaucracy but safety too. The FDA has always insisted that any shortcuts it takes are balanced by the tight monitoring of fast-track drugs once they're in use. But in this case, at least, the monitoring was badly inadequate. The panel learned, for example, that 200,000 patients have taken Rezulin for a year or more--or maybe it's 400,000. No one could say if the risk leveled off after six months or kept growing. No one knew if the 35 deaths represented all those who died from Rezulin. Complained...
...What the panel didn't question was Rezulin's immense promise. In most folks, insulin (a substance produced in the pancreas) helps ferry blood sugar into cells, where it is used for energy. But for the 15 million or so Americans with Type II diabetes, cells resist insulin's entry; eventually they weaken and die. Traditional treatments involve boosting the amount of insulin available to the cells. But these can have side effects, and for some people they don't work...
...ground. One wishes it could be said that this was the final indignity Farnsworth had to suffer, but it was not. Ten years later, he appeared as a mystery guest on the television program What's My Line? Farnsworth was referred to as Dr. X and the panel had the task of discovering what he had done to merit his appearance on the show. One of the panelists asked Dr. X if he had invented some kind of a machine that might be painful when used. Farnsworth answered, "Yes. Sometimes it's most painful...