Word: fda
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Dates: during 1980-1989
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...past decade have been decidedly sour. First the Food & Drug Administration barred cyclamates because they might bring on bladder cancer. Then after saccharin was also linked to bladder cancer, the agency proposed banning that sweetener, an action averted only by an act of Congress. Last week the FDA broke new ground, announcing its approval of a low-calorie sugar substitute called aspartame...
...FDA also wondered whether the patient consent forms proposed by the Utah doctors fully spell out the kind of life the implant recipient should expect. The heart runs on compressed air and is electrically powered. That means the patient will be permanently tethered to air hoses and plugged into an electrical outlet, a sedentary, chair-to-bed existence...
...concern over when and how doctors would decide to implant the plastic and aluminum device. The Utah team said it would try the procedure only as a last resort, when a patient's heart could not take over for the heart-lung pump used during surgery. But the FDA suggested that the doctors first consider using a less drastic mechanical aid, the so-called assist device. This piece of equipment leaves the natural heart intact but takes over the operation of one of the pumping chambers, usually the left ventricle, giving it a chance to recover and resume functioning...
Finally, the FDA believes the proposal does not go into enough detail on what, if any, information will be gathered after the implant. Will the researchers, for example, record the effect on the blood, measure exercise tolerance of the patient, or monitor the new heart's pumping ability...
...FDA did not concern itself with some of the longer-range questions about the artificial heart, such as how to pick recipients or how to pay for implants (upwards of $50,000). William DeVries, the surgeon who hopes to do the first operation, and Robert Jarvik, who designed the device, hope that a revised application can be submitted within two months. Cheitlin was most encouraging about their chances: "They are going to come through with an acceptable proposal. I don't see any problem that it will eventually be granted...