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Star Tribune Online Nation/World FDA resisted proposals to test aspartame Greg Gordon Star Tribune 22 November 1996, p. 1 WASHINGTON, D.C. -- Food and Drug Administration officials have for years resisted proposals from government scientists for comprehensive studies of the safety of the artificial sweetener aspartame, which 100 million Americans consume as NutraSweet. Between the early 1980s and 1994, scientists at the National Institutes of Environmental Health Sciences (NIEHS) proposed at least four times that the government's leading program for toxicology research fund such studies, the Star Tribune has learned. The government scientists said they wanted the National Toxicology Program to conduct animal studies to resolve questions about the sweetener's cancer risks. After each of these "nominations," NIEHS officials elected not to pursue the research at the urging of FDA officials, who said they were satisfied with industry-sponsored research that found no health risks. Now, after a scientific paper by researchers at Washington University of St. Louis has rekindled fears that aspartame may cause deadly brain tumors, some present and former NIEHS officials are criticizing the FDA for using its influence to delay research that could have settled some or all of the safety issues. Amid calls from consumer groups for more testing, NIEHS managers said they may reconsider their decision. FDA officials, including Commissioner David Kessler, insist that aspartame is safe and needs no more testing. Alan Rulis, who oversees the approval of food additives at the agency, said this week that the FDA would need "a scientific basis" to endorse further research. Two NIEHS toxicologists, James Huff and June Dunnick, said they sought independent studies not because they have data suggesting NutraSweet causes health problems, but because of the nagging safety concerns about one of the most pervasive food additives. Disclosure that federal scientists outside the FDA sought more studies adds a new twist to a long-running controversy over the manner in which the agency approved the popular, low-calorie sweetener in 1981, expanded its uses in 1983 and defended its safety over the last 15 years. NIEHS officials say the FDA's resistance effectively prevented government research that might have resolved conflicts between scores of industry-funded studies, which have found the sweetener to be safe, and dozens of independent studies that have raised health concerns. Deputy FDA Commissioner Michael Friedman earlier this month, in challenging the scientific soundness of the latest published paper suggesting the sweetener may cause brain tumors, said the agency has gone to great lengths to review all animal data on aspartame. Indeed, he said, scientists at the Toxicology Program did not feel there was "sufficient evidence" to warrant further study. He did not mention that the FDA, which helps fund the toxicology program, repeatedly opposed such studies. "It's a wonderful way to ensure that it isn't tested," said David Rall, who retired in 1990 after directing NIEHS and overseeing the National Toxicology Program for 19 years. "Discourage the testing group from testing it and then say it's safe." Widespread consumption Rall said consumption of aspartame has "vastly exceeded expectations when the original toxicology was done" in the early 1970s by Illinois-based G.D. Searle & Co., which owned the patent. (Searle was purchased in 1985 by the St. Louis-based Monsanto Co., which now sells close to $1 billion in NutraSweet annually through a subsidiary, the NutraSweet Kelco Co.) Rall said that "any compound that is that widely used needs to be retested with modern methods every once in awhile." He said scientists have much better technology and know much more about how to detect cancer than they did in the 1970s. Like many other scientists, Rall said he is skeptical of the newly published analysis of brain tumor data by researchers at Washington University of St. Louis. But he called "preposterous" the assertion this week by Gerald Moser, NutraSweet Kelco's senior medical consultant, that it would be impossible for the sweetener to cause cancer. Richard Nelson, a spokesman for NutraSweet Kelco, said the firm feels "the more than 200 tests that have been done prior to and subsequent to the approval of aspartame more than adequately demonstrate the safety of the ingredient." If the FDA wanted more tests, he said, "we'd be the first ones in line to make sure those tests are accomplished," although the company might propose a testing laboratory different from the Toxicology Program's. Each year, the National Toxicology Program at Research Triangle Park, N.C., begins multiyear studies on seven to eight substances selected from scores of "nominations" by committees of scientists from about a dozen federal agencies. Decisions are difficult because cancer studies alone cost $1.5 million to $4 million and take four years or more, and the program's annual budget is limited to $80 million, said George Lucier, director of NIEHS' component of the Toxicology Program. Before formally proposing a study to the full committee, NIEHS officials customarily consult with the agency that regulates the nominated substance to gauge its interest in further research, Lucier said. The agency's position is given great weight, he said. Lucier's deputy, John Bucher, said at least two other individuals from outside the agency, whom he did not identify, also nominated aspartame for further research. He said when approached on each of the half-dozen occasions when aspartame was nominated, FDA officials said they felt no further research was needed. NIEHS officials then put off the proposals without presenting them to the interagency committees, he said. Rall said he personally took one of the proposals to the FDA but that Sanford Miller, then chief of the Center for Food Safety and Applied Nutrition, asked him "to put it off a year or two." Huff said that in his 1994 nomination, he planned to seek complete life cycle animal testing for all possible toxic effects of aspartame, from birth through mating, pregnancy and weaning "to mimic the human experience." "The FDA has a ton of adverse reaction reports" from the public, Huff said. "They downplay it. They just say, 'Well, it's idiosyncratic.' . . I think it's real." Health complaints FDA officials said that, since 1981, about 8,000 consumers have complained to the agency that the sweetener has caused them physical ailments, including headaches, nausea, vision problems and seizures. Scientists consider such reports anecdotal and not proof of a causal relationship. Huff said that the number of reports is worrisome, though, because "if 100 people have a headache after chewing NutraSweet gum, only one's going to report it." The FDA's Rulis, who was not involved in the approval of aspartame, said the agency's reluctance to support more studies must be considered in full context: It uses computer databases to track the continuing safety of thousands of food additive uses. Mere concern about a product, he said, "cannot be allowed to drive a decision about a safety study. "What has to drive it is the scientific basis for that concern. That's what we're looking for here and what we don't see in this case." David Hattan, who heads a "Health Effects Evaluation" unit at the FDA's Center for Food Safety , said NIEHS officials never pushed hard for further studies but merely sought the agency's judgments as to whether more testing is needed. Dunnick, who joined Huff in urging a study in 1994 and also nominated the sweetener in the late 1980s, said she did so because women expressed concerns about the sweetener's safety during a National Institutes of Health survey. Aside from the consumer complaints, a major reason for the debate over aspartame has been a controversy over Searle's early laboratory studies. Two FDA investigative task forces issued scathing reports in the mid-1970s on the quality of the company's research. In 1976, the FDA's general counsel requested a federal grand jury investigation of the company because of alleged irregularities in its laboratory. (Such an investigation was never undertaken.) In 1980, a Public Board of Inquiry that was asked to review scientific data on aspartame voted 3-0 to keep it off the market pending further studies on the brain cancer issue. In the first months of the Reagan administration, new FDA Commissioner Arthur Hull Hayes said a late-arriving industry study cleared up the cancer questions. He overturned the Board of Inquiry and put NutraSweet on the market. NutraSweet Kelco has said subsequent studies have confirmed the integrity of Searle's original research.
Copyright © 1996 Star Tribune. Reprinted with permission of the Star Tribune. No further republicaiton or redistribution is permitted without the written permission of the Star Tribune. Visit http://www.startribune.com (and say "Thank You" for responsible reporting!)
WebMasters Note: A special thank you to the author for obtaining permission to post this well-done article. I pray that more journalists see the crying need to adequately report on situations where our government organizations, mandated to serve and protect our citizens with OUR conscent... and using our money... are shown to be doing less than expected. Cause and effect! Millions of unwary victims consume aspartame. All are affected! Only time, susceptability, and accumulated damage separate those who have immediate reactions from those who require, as I did, fifteen years to get forced to my knees, praying for deliverance from the pain, complications, and hopelessness attributable to a purposely misinformed medical system and public! The FDA's disdain for what they call "anecdotal" evidence (which they try to ignore), defies logic. Where there is smoke, there is most often fire. Aspartame, by their own admission, is the MOST complained about substance. The forgoing article mentioned 8000 complaints. By their own admission, fewer than 1% of victims ever report a problem. This balloons that number of affected users to at least 800,000 who SHOULD have reported it! My certified letters to Dr. Kessler, FDA commissioner, and to Dr. Donna Shalala, head of the DHHS, have gone unacknowledged and unanswered. I doubt that my CERTIFIED complaint (return receipt requested and obtained) has been added to their list! Dr. Friedman, acting FDA commissioner, has yet to respond to a recall demand of aspartame (both Email and postal) and to any of my Email messages. Janet Reno, head of the Department of Justice, has not responded to any messages. My two elected officials responded by obtaining and forwarding the FDA disinformation packages. I informed them both that I had all that "documentation" and much more, and I expected them to determine why a substance that contains free methanol, that readily converts to formaldehyde and a side-order of DKP (a tumor agent) while cooling off in refrigerator in the original unopened container... should be a part of my FDA "approved" diet. To date, all of those requests have gone unanswered. Are you concerned or angry? Concerned, alarmed, angry... whatever, should you wish to query anyone or get your own responses (or non-repsonses) contact any of the following: FDA Commissioner 5600 Fishers Lane Rockville, Maryland 20857 Or... goto my "government" page listing and write to: The President The Vice President The First Lady Secretary of DHHS (Boss over FDA)