The history of Aspartame: An American story

By Louisa Enright | Oct 24, 2010

The Food and Drug Administration approved aspartame in 1981. The decision was made solely by a political appointee, Dr. Arthur Hayes, Jr.

Devra Davis, a preeminent cancer epidemiologist, tells the aspartame story in "The Secret History of the War on Cancer" (2007) as it illustrates, yet again, how successful American corporations have been in their quests to sell products they know to be poisonous, but which make huge profits. This story is, unfortunately, a common story in America.

In 1965, James Schlatter created aspartame while working on new drugs to treat ulcers. Schlatter licked his fingers to pick up some papers and tasted the intense sweetness of the chemical compound he had just created. G. D. Searle, of the pharmaceutical company G. D. Searle & Company, owned the patent, and Searle’s company did the original safety research on Aspartame.

In November 1970, cyclamate, the most commonly used low-calorie sweetener, was removed from the market. And, the safety of saccharin was being questioned. Aspartame, thus, could become a replacement no-calorie sweetener.

In February 1973, Searle applied for FDA approval of aspartame. But, FDA scientist Martha Freeman determined that the Searle studies on the safety of aspartame were not adequate and recommended that aspartame not be allowed on the market. Nevertheless, in July 1974, the FDA gave its first limited approval to aspartame for use in dry foods. Searle called the product NutraSweet.

Immediately, in August 1974, two men filed an objection against aspartame’s approval: Jim Turner, a consumer advocate who had helped remove cyclamate from the market, and Dr. John Olney, a research neurologist and psychiatrist whose pioneering research with monosodium glutamate enabled removing it from baby foods. Turner and Olney’s protest spurred an FDA investigation of the Searle studies.

Turner’s timeline notes that Searle knew that Olney’s research had shown that aspartic acid, an ingredient in aspartame, caused holes to develop in the brains of infant mice because Olney personally told him so. And, that one of Searle’s researchers confirmed Olney’s findings in a similar study.

Davis writes that Olney told her that in 1969 Searle asked Harry Waisman to study aspartame in seven infant monkeys. In one year, one monkey died and five had “suffered severe epileptic seizures.” Waisman died in the spring of 1971, so his research was not completed. Olney’s research, however, showed that aspartame paired with monosodium glutamate produced brain tumors in rats.

In January 1977, FDA Chief Counsel Richard Merrill formally asked the U.S. Attorney's office to convene a grand jury to investigate Searle for knowingly misrepresenting the material facts about the safety of aspartame. That request marks the first time in FDA history that the FDA requested a criminal investigation of a manufacturer.

In March 1977, Searle hired politically powerful Donald Rumsfeld as CEO of G. D. Searle & Company. Rumsfeld had been Chief of Staff and Secretary of Defense for Gerald Ford. In July, Samuel Skinner, the U.S. attorney in charge of the grand jury investigation, took a job with Searle’s law firm. His replacement, William Conlon, joined Skinner 15 months later.

In August 1977, the FDA released the Bressler report on Searle’s safety studies. This report, notes Davis, “depicted a stunning number of irregularities”— an assessment senior FDA investigator Jacqueline Verrett, a toxicologist, later seconded in 1987 testimony to the U.S. Senate. Verrett’s summation was that it “'is unthinkable that any reputable toxicologist… could conclude anything other than that the study was uninterpretable and worthless, and should be repeated.'” Turner writes that the “report finds that 98 of the 196 animals died during one of Searle’s studies and weren’t autopsied until as much as one year later.” And, that growths found in the animals were neither reported nor diagnosed.

In December 1977, the grand jury investigation was dropped. Skinner’s withdrawal and Conlon’s inactivity stalled the investigation sufficiently that the statute of limitations ran out. Davis writes that “expert legal advice” from former FDA officials who now worked for Searle helped “Searle run out the clock.” She notes that on Oct. 12, 1987, United Press International reported that “more than 10 American government officials who had been involved in the decision to approve aspartame were now working in the private sector with or for the aspartame industry.” Davis further notes that “scientific evidence became irrelevant” in the FDA’s approval process.

In June 1979, the FDA established a Public Board of Inquiry to rule on safety issues surrounding aspartame. In September 1980, the PBOI concluded that aspartame should not be approved pending further investigations of brain tumors in animals. In November 1980, Ronald Reagan won the presidential election. Rumsfeld told a Searle sales meeting that he would get aspartame approved within the year by using his political pull in Washington.

In January 1981, Rumsfeld, now part of Reagan’s transition team, “hand picks” Hayes to be the new FDA Commissioner. The day after Reagan’s inauguration, Searle reapplied to the FDA for approval for aspartame. Hayes was appointed to the FDA in April 1981. In March 1981, Mark D. Gold, of the Aspartame Toxicity Information Center, in a January 2003 request to withdraw approval of aspartame, documents that a five-member FDA commissioner’s panel was created to review issues raised by the inquiry board. Three members were going to vote for disapproval, so Hayes added a toxicologist to the panel. The members split three to three. Gold takes this part of the story from a damming investigation done by Gregory Gordon of United Press International.

So, in July 1981, Gold writes, “as one of his first official acts,” Hayes overruled the inqury board and ignored the findings of the original five-member FDA commissioners’ panel. Gold charges that Hayes also “ignored the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C. 348), which says that a food additive should not be approved if tests are inconclusive.” Davis writes that FDA aspartame approval was extended for liquids and vitamins within a year.

Turner writes that in September 1983 Hayes resigned from the FDA “under a cloud of controversy” for taking ”unauthorized rides aboard a General Foods jet.” Hayes winds up at the chief public relations firm for both Searle and Monsanto, which, in 1985, buys the NutraSweet Company.

Turner writes that when Hayes approved aspartame, he said that aspartame “has been shown to be safe for its proposed uses” and that “few compounds have withstood such detailed testing and repeated close scrutiny.” Davis, however, repeatedly demonstrates in her book that tests performed by industry are not reliable, which is a key problem in our regulatory process.

Davis describes, also, how in 1996 Ralph G. Walton, a professor of clinical psychology at Northeastern Ohio University, for the news show 60 Minutes, surveyed 165 separate aspartame studies published in medical journals over a 20-year period. Walton, writes Davis, found the following: “All of the studies that found aspartame safe happened to be sponsored by industry” and “every single one that questioned its safety was produced by scientists without industry ties.”

You decide: conspiracy theory or collusion of government and industry?

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