APn 18.11.96 22:01
Copyright 1996 The Associated Press. All rights reserved.
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By LAURAN NEERGAARD
Associated Press Writer
WASHINGTON (AP) -- The Food and Drug Administration is reaffirming the safety of NutraSweet, to rebut charges Monday that the artificial sweetener may be linked to brain tumors.
A recent Washington University study found brain tumors increased by about 10 percent in the mid-1980s, shortly after NutraSweet hit the market. The study does not prove NutraSweet is a culprit. Study author Dr. John Olney did not examine whether tumor patients actually ate NutraSweet -- and government figures show the increase in brain tumors leveled off beginning in 1985, four years after NutraSweet began selling.
Olney acknowledged Monday that he lacks proof NutraSweet is dangerous, but he joined consumer advocates to demand the FDA and Congress order new, large studies of NutraSweet, also known as aspartame. "It's possible aspartame could be a weak carcinogen," he said.
Sales of NutraSweet have risen dramatically in the last decade. So if it really caused brain tumors, the increase should have continued as people ate more NutraSweet, explained FDA Commissioner David Kessler. A link "just doesn't hold up," said Kessler, who previously ordered a review of NutraSweet because of Olney's concerns. That review has been completed. "This is a safe product for the American public to use," added FDA Deputy Commissioner Michael Friedman, a former National Cancer Institute oncologist who led that review.
NCI says brain tumors rose from 5 per 100,000 Americans in 1973 to about 6.4 per 100,000 in 1985, with the sharpest jump between 1984 and 1985. Preliminary data show 6.2 tumors per 100,000 people in 1993. NutraSweet has long been controversial, blamed for reactions from vertigo to seizures.
Cancer fears surfaced when a 1970s study found rats fed aspartame had more brain tumors than rats without aspartame in their diets. Other studies failed to find a link, but FDA's outside scientific advisers in 1980 urged more rigorous research before NutraSweet was sold. In 1981, a Japanese rat study found no cancer link, and the FDA approved NutraSweet.
But the Community Nutrition Institute, a consumer group, on Monday called that research "shoddy." And Olney demanded a study of whether aspartame could interact with substances in the stomach to cause genetic mutations.
Manufacturer Monsanto Co. responded that NutraSweet is the most studied food additive sold, and accused critics of "causing unwarranted alarm."