The History of Aspartame: An American Story
The Food and Drug Administration (FDA) approved aspartame in 1981. The decision was made solely by a political appointee, Dr. Arthur Hayes, Jr., despite the fact that since 1973 FDA scientists had consistently and repeatedly refused to recommend aspartame because industry safety studies were inadequate. Indeed, since the early 1970s the research of scientists not connected to industry has demonsed that aspartame is seriously dangerous for humans in multiple ways.
Devra Davis, a preeminent cancer epidemiologist and environmentalist, tells the aspartame story in her book The Secret History of the War on Cancer (2007). For Davis, the aspartame story is yet another illustration of how successful American corporations have been in their quests to sell products they know to be poisonous for humans, but which can and do make huge profits. The story of how industry got aspartame approved without demonstrating conclusively its safety is worth reviewing because it is, unfortunately, a common story in America, though not one many Americans know since they assume wrongly that their government organizations are acting to protect them.
Mr. James Schlatter created Aspartame in 1965 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 research on aspartame—research which claimed to show aspartame to be safe for humans (Jim Earle, “Sugar-Free Blues: Everything You Wanted to Know About Artificial GSweeteners,” February 2004, http://www.westonaprice.org/modern-foods/570-sugar-free-blues.html).
The context surrounding the battle to win approval for aspartame includes the fact that in November 1970, cyclamate, the most commonly used low-calorie sweetener, was removed from the market because some scientists had associated it with cancer. At the same time, the safety of saccharin was being questioned. Aspartame, thus, could become a replacement artificial sweetener for a market searching for lucrative diet products (Jim Turner’s timeline, http://www.swankin-turner.com/hist.html).
In February 1973, Searle applied for FDA approval of aspartame. But, Davis reports, Martha Freeman, an FDA scientist, determined that “the information submitted on the safety of aspartame was not adequate.” Freeman 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 (420). 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 (MSG) enabled removing it from baby foods. Turner and Olney’s protest spurred an FDA investigation of the Searle studies (Turner).
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 had “confirmed Dr. Olney’s findings in a similar study.”
Davis writes that Dr. 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 (MSG) produced brain tumors in rats (420).
In January 1977, the FDA Chief Counsel, Richard Merrill, formally asked the U.S. Attorney’s office to convene a Grand Jury to investigate G. D. Searle for knowingly misrepresenting the material facts about the safety of aspartame. This request marks the first time in FDA history that the FDA requested a criminal investigation of a manufacturer (Davis).
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 and would become Secretary of Defense for George W. Bush. 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 fifteen months later.
In August 1977, the FDA released the Bressler report on Searle’s studies claiming the safety of aspartame. 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 (420-421). 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’ ” (Verrett in Davis, 421). 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.
Mark D. Gold of the Aspartame Toxicity Information Center, in a January 2003 request to withdraw approval of aspartame, covers the full range of the Searle safety studies’ irregularities: http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt. Gold’s history of the aspartame history is worth a look.
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 October 12, 1987, United Press International reported that “more than ten 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” (422). Davis further notes that “scientific evidence became irrelevant” in the FDA’s approval process (422).
In June 1979, the FDA established a Public Board of Inquiry (PBOI) to rule on safety issues surrounding NutraSweet. In September 1980, the PBOI concluded that NutraSweet should not be approved pending further investigations of brain tumors in animals (Turner, Davis 421-422).
The turning point came in November 1980 when Ronald Reagan won the Presidential election. Rumsfeld told a Searle sales meeting that he would get aspartame approved within the year (Davis 422, Turner Timeline). Turner writes that Rumsfeld said he would use his political pull in Washington to get the job done rather than using scientific means.
In January 1981, Rumsfeld was part of Reagan’s transition team. Turner writes that Rumsfeld “hand-picked” 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, Gold writes, a five-person FDA commissioners’ panel was created to review issues raised by the PBOI. Three members were going to vote for disapproval, so Hayes brought in a toxicologist to the panel, and the members split 3 to 3. Gold takes this part of the story from an investigation done by Gregory Gorden of United Press International that included the irregularities involved in this panel’s determinations.
In July 1981, “as one of his first official acts,” Hayes overruled the PBOI and ignored the intent of the original five-member FDA commissioner’s panel. Gold notes that Hayes 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 (Federal Register 1981, Farber 1989, page 38).” Davis writes that the initial approval is for use in dry products, but that approval was extended for liquids and vitamins within a year (422).
Turner writes that in September 1983 Hayes resigned from the FDA “under a cloud of controversy” regarding taking ”unauthorized rides aboard a General foods jet.” Hayes winds up at Burston-Marsteller, the chief public relations firm for both Searle and Monsanto, which, in 1985, buys Searle’s aspartame business, The NutraSweet Company.
Turner writes that when Hayes approved aspartame for dry use, 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 factor in what is wrong with 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 twenty-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” (423).
You must decide if aspartame is safe or not, if the approval process was corrupt or not, or if all of the information above is just a huge conspiracy theory, as the government and industry claim. I’m going to believe Davis, especially after reading her book about this old, repeated American story of the collusion of our government and industry.
(Note: There are at least three aspartame timelines online. The most complete—and the one the other two likely use–is Mark D. Gold’s, which was submitted to the FDA in 2003: http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt). Jim Turner and Rich Murray have the other two timelines.
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