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Aspartame - What you don"t know can hurt you - Why isn"t the FDA protecting your health?

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"Aspartame was the most studied additive ever approved by the Food and Drug Administration," argues Martha Stone, Nutrition Advisor and professor at Colorado State University. Stone, an advocate for aspartame, claims that "aspartame wouldn't have gotten to the market if it caused problems in humans" (qtd. In Castrone 12D). Does "most studied" imply safe for human consumption? More importantly, what were the results of these studies and how was aspartame approved? An in depth look at the history of aspartame approval reveals a trail of suspicious methods and possible collusion between the FDA and the G. D. Searle company, manufacturer of aspartame.

Aspartame was discovered in 1965 by a chemist from the Searle company (Farber 53). After researching their product to determine its safety, Searle submitted tests to the FDA for the approval of aspartame. According to The Deadly Deception, compiled by the Aspartame Consumer Safety Network, the FDA approved aspartame in 1974 for limited use based on the tests selected by Searle. After the approval, the FDA learned that some of Searle's other products had serious side effects. Also, a study done by Dr. John Olney, research psychiatrist from the Washington School of Medicine, revealed that holes in the brains of mice appeared after the consumption of aspartic acid, a major ingredient in aspartame. This study was submitted to the FDA after they had already approved aspartame for limited use. This new evidence prompted the FDA to organize an internal Task Force to investigate Searle's original research (7-8).

In their investigation, the FDA 1975 Task Force reviewed a study done for Searle in 1969 by Dr. Harry Waisman, Professor of Pediatrics at the University of Wisconsin. The study involved feeding aspartame mixed with milk to seven infant monkeys. After 300 days, five monkeys had gran mal seizures and one died. Dr. Waisman died before all of his studies were completed. The Task Force uncovered that when Searle had submitted the Waisman study to the FDA, all the negative data had been omitted (The Deadly Deception 6-7).

The Task Force also discovered that questionable lab practices had been performed by researchers from Searle. In a summary of their investigation, the Task Force concluded:

We have uncovered serious deficiencies in Searle's integrity in conducting high quality animal research to accurately determine or characterize the toxic potential of its products. . . . The cumulative findings of problems within and across the studies we investigated reveal a pattern of conduct which compromises the scientific integrity of the studies. (Qtd. in The Deadly Deception 8-9).

This investigation revealed that Searle researchers had cut out tumors in animals that had been fed aspartame and neglected to report all of them or check for cancer. Also, animals that were "reported as dead, were later reported alive again" (The Deadly Deception 9).

Other findings of the Task Force included "falsified data" from another Searle product, the Copper 7-IUD, a birth control device. This product had to be pulled off the shelves due to a $9,000,000 lawsuit. Searle lost even though they claimed the IUD was safe (The Deadly Deception 8).

As a result of the findings of the 1975 Task Force, a smaller Task Force was assigned in 1977 to investigate Searle's original research even further. This investigation uncovered that Searle had again falsified data by submitting inaccurate blood tests. Apparently, they had substituted unrelated animal tests because of instrument problems. In another study, a closer look revealed that uterine tumors had developed in some test animals. Searle "admitted" that these tumors were related to the ingestion of a breakdown product of aspartame, Diketopiperazine (The Deadly Deception 10).

Due to the 1977 Task Force findings, FDA ordered a grand jury investigation of Searle's aspartame studies. Assistant U.S. Attorney, William Conlon, and U.S. Attorney, Thomas Sullivan, failed to start any legal action against Searle concerning aspartame testing. Consequently, time ran out and the grand jury investigation terminated. Conlon was then hired by the law firm that represented Searle. It is interesting to note that this was not the first time Searle had been involved in a grand jury investigation. They had been accused of unreported tumors in the testing of their two drugs, Flagyl and Aldactone (The Deadly Deception 10-11).

According to an article in Technology Review, aspartame came up for approval again in 1980. This time the FDA recommended that a Public Board of Inquiry be created to determine aspartame's safety. The Board was composed of three scientists. They "recommended keeping aspartame off the market until further animal tests could show that it did not cause tumors" (Farber 53).

The disapproval of aspartame by the Public Board of Inquiry wasn't enough. The Deadly Deception states that a five member Commissioner's Team of Scientists was then formed to look at the results of the Public Board of Inquiry conclusions. Three scientists voted against approval and two scientists voted for approval. Inexplicably, a sixth member joined the team with a vote of "yes" to the approval of aspartame creating a deadlock. Dr. Goyan, the FDA Commissioner, decided not to approve aspartame at this time (13, 16).

In April of 1981, Dr. Arthur Hayes became the new Commissioner. Searle applied again for approval of aspartame. A few months later, Dr. Hayes approved aspartame for use in dry foods. In 1983, he approved aspartame for use in diet soft drinks (The Deadly Deception 14-15). One month later, Dr. Hayes left the FDA and within three months he was working for Searle's advertising agency, Burson-Marsteller (Farber 53).

Aspartame's history of approval speaks for itself. The Searle company, whose sales were 700 million in 1992 (Therrien 42), had much to gain from the approval of aspartame. After researching their own product, Searle selectively chose the tests and then submitted them to the FDA. How can Searle, the company who stands to profit, determine which reports are to be given to the FDA? An instant bias is created when this is allowed to happen. Even when independent researchers, such as Olney and Waisman, were approached by Searle to conduct safety tests, Searle withheld important information that these researchers had discovered. The Searle company's effort to produce a clear picture on the safety of aspartame is at best a weak attempt. Falsified data, unscientific lab practices, and a history of problems with some of their other products makes it hard to believe that Searle's concern for the public's health takes precedence over financial gains.

The FDA should be the objective source to verify if Searle's research is valid. The FDA has the final approval and the public depends on them to determine the safety of a product. In this particular case, the repeated reviewing of aspartame studies by forming two task forces, a Public Board of Inquiry, and two teams of scientists seems redundant if not suspicious. The research indicating tumors and falsifying of data resurfaced every time. It appears that all of these attempts were to ultimately get aspartame approved, not to determine it's safety. If the FDA had been really concerned, they should have insisted on reviewing all of the original research before it was approved for limited use in 1974. Even if the FDA's repeated attempts to investigate aspartame's safety were legitimate, ultimately, it was Commissioner Hayes' responsibility to determine if this product should enter the market. When he approved aspartame, it was more than questionable if his intentions were sincere. His employment with FDA was just long enough to get aspartame approved and then he conveniently quit and was hired by a Searle related company! How can we rely on the FDA to make the right decisions concerning aspartame approval if we are suspicious of their motives?

How does all this relate to the safety of aspartame? First we must explore what safe means. The FDA defines safe as a "reasonable certainty of no harm" (Farber 48). Searle's evaluation of aspartame's safety was compromised when they withheld negative data and supplied inaccurate test results. Without valid research, "reasonable certainty of no harm" is difficult to determine. How can aspartame be on the market if the FDA and Searle failed to determine whether it was safe or not?

Brain tumors and seizures in aspartame-fed animals indicate a possible risk to humans. The dictionary definition of safe means "not presenting or involving any danger or risk" (Webster's 877). Does this mean aspartame is not safe? The answer lies in the hands of the public. Although aspartame was not tested on humans before its approval, it now has been tested on the public by default. Over 200 million Americans consume aspartame products (Weininger 1/ZZ1). We have been the guinea pigs in the testing of aspartame without even knowing it. A look at aspartame's ingredients and its devastating effects on human beings provide the evidence for avoiding all aspartame products.

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