The Man Who Changed Our Food
Arthur Hayes Jr., who led the Food and Drug Administration when it approved aspartame in 1981 (NutraSweet) and 1983 (Equal), died February 11, 2010 in Danbury, Connecticut.
According to the February 15 issue of the New York Times, Dr. Hayes granted approval for the use of the sugar substitute aspartame in dry foods and as a tabletop sweetener in 1981. "Research had found," the Times said, "that aspartame was associated with high rates of cancers in rats that had been given large doses, starting at what would be the equivalent of four to five 20-ounce bottles of diet soda a day for a 150-pound person."
The Times also said that "research done after Dr. Hayes's time as commissioner indicated that aspartame can sometimes cause incapacitating headaches and even seizures." Today, aspartame, which is marketed as NutraSweet (when used as a food additive) and Equal (the tabletop version), is now also used in over 5,000 products like soft drinks, breakfast cereals, pudding mixes and chewing gum.
Here we see a thumbnail sketch of aspartame's story: a sweet-tasting chemical, in spite of having caused high rates of cancers in rats before approval, and subsequently causing incapacitating headaches and even seizures, receives an FDA go-ahead to be consumed by hundreds of millions of human beings. Clever marketing, creating the soothing names "NutraSweet" and "Equal," spur sales of the chemical into the billions of dollars.
An even darker story lies behind these few troubling facts.
The First Approval: 1974
In 1965, G.D. Searle & Company chemist James M. Schlatter, working on an anti-ulcer drug, accidentally discovered that aspartame tasted sweet. As did the discoverers of saccharin and cyclamate before him, he licked his finger and for the first time a human tasted what would revolutionize the sweetener market. Searle launched an effort to market their wonder additive, finally succeeding in 1981.
The story leading up to that 1981 approval and the story following it make clear why prudent consumers avoid products containing aspartame. This sweetener consists of the natural amino acids L-aspartic acid and L-phenylalanine, as well as methyl alcohol. It creates byproducts such as free amino acids, methanol and formaldehyde. In certain markets, aspartame is manufactured using a genetically modified variation of E. coli.
Two hundred times sweeter than sugar with almost no calories, aspartame is popular in certain diets. However, in addition to many safety problems, it tastes different than sugar, breaks down in heat, fails in baking, degrades shortening shelf life and loses flavor in some products, leaving an odd aftertaste for some and non-flavor or watery aftertaste for others. Still, smooth marketing turned it into a giant money maker.
In October 1980 an FDA Public Board of Inquiry (PBOI) found that aspartame caused an unacceptable level of brain tumors in animal testing and ruled that it should not be added to food. This ruling capped 15 years of regulatory deception by the FDA and Searle (acquired by Monsanto in 1985). Two decades of maneuvering, manipulating and dissembling by FDA, Searle and Monsanto followed the PBOI ruling.
Early tests of aspartame showed it produced microscopic holes and tumors in the brains of experimental mice, epileptic seizures in monkeys, and was converted by animals into dangerous substances, including formaldehyde. In 1974, however, in spite of the information in its files, the FDA approved aspartame as a dry-foods additive. The approval to market was short lived.
Blocking Aspartame/NutraSweet Approval for Seven Years
I, along with Dr. John Olney MD, a prominent brain researcher from Washington University in St. Louis, filed petitions with the FDA seeking a public hearing on the evidence. For the first and only time in its history, the FDA made public the data supporting its food-additive decision. Here was the evidence of monkey seizures, mouse brain cancers, eye damage, and very sloppy laboratory procedures at Searle.
Dr. Olney had already shown that one aspartic acid feeding caused microscopic holes in rat brains. Phenylalanine, aspartame's second amino acid component, was known to lead to mental retardation, brain damage, and seizures in some susceptible children suffering from Phenylketonuria (PKU). Methanol, aspartame's third ingredient, is highly toxic to humans and, in large amounts, is know to cause blindness.
Faced with this array of possible health dangers, the FDA granted the hearing requests in lieu of withdrawing its aspartame approval. The agency convinced Searle to refrain from marketing the sweetener until after completion of the hearing process. It then proposed that a Public Board of Inquiry (PBOI) review the matter. Backing and filling by the agency kept the PBOI from convening until January of 1980.
In July of 1975, while the FDA set up the PBOI, an FDA inspector conducting a routine review of Searle's testing facilities found many deviations from proper procedures. Animals died and came back to life, aspartame feed got mixed with unsweetened feed, and results seemed fudged. This report spurred Congress to pass laboratory regulations and the FDA commissioner to panel a Special Task Force to review Searle's labs.
In December of 1975 the Task force reported serious problems with Searle's research on a wide range of products, including aspartame. It found 11 pivotal aspartame studies conducted in a manner so flawed as to raise doubts about aspartame safety and create the possibility of serious criminal liability for Searle. Based on this report, the FDA stayed (suspended) aspartame's approval, keeping the sweetener off the market.
Reviewing the Data
To review the questionable data, the FDA contracted, over serious internal objection, with a group of university pathologists (paid by Searle) to review reporting of the results of most of the studies, set up a task force to review the validity of three studies, and asked the U.S. Attorney for Chicago to seek a grand jury review of the monkey seizure study. Searle managed to thwart each of these efforts.
The pathologists paid by Searle only reviewed the failure to properly report data, while not reviewing the design or conduct of the pivotal studies. They found no serious reporting problems. The FDA task force found Searle's key tumor safety study unreliable, but this was ignored. The U.S. attorney let the statute of limitations run out, then (along with two aides) proceeded to join Searle's law firm.
While these committees met, the FDA organized the PBOI. Searle, petitioners Olney and myself, and the FDA Bureau of Foods each nominated three members for the board and the FDA commissioner selected one member from each list. Three world-class scientists made up the board, took evidence, and drafted and signed an unanimous report blocking the further marketing of aspartame.
The board, which convened in January of 1980, rejected the Olney/Turner request that the commissioner's task force information contained in the Bureau of Drugs be included in its deliberations. Still, in October 1980, looking at only the evidence in Bureau of Foods files, the board blocked aspartame marketing until the tumor studies could be explained. The board said: "approval of aspartame for use in foods should be withheld at least until the question concerning its possible carcinogenic (cancer) potential has been resolved by further experiments. The Board has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive under its intended conditions of use." Unless the commissioner overruled the board, the matter was closed.
The New Commissioner Intervenes: Politics Overrules the Board
In November 1980, one month after the aspartame PBOI report, the country elected Ronald Reagan President. Donald Rumsfeld (a former congressman from Skokie, Searle's home town, White House chief of staff, secretary of defense and, since January 1977, Searle's president) joined Reagan's transition team. Rumsfeld began a full court press against the board decision, orchestrating aspartame's approval from inside the administration.
In January 1981 Rumsfeld told a sales meeting (as one attendee reported) that he would call in his chips and get aspartame approved by the end of the year. On January 25th, the day the new president took office, the previous FDA commissioner's authority was suspended. Three months later the commissioner's job went to Dr. Arthur Hull Hayes, who had done drug research on army recruits while Rumsfeld was defense secretary.
Transition records give no reason for the choice of Hayes, a professor with a defense department connection and no particular background in food and drug regulation. His Pentagon proximity to Rumsfeld seemed the primary explanation. In July, Hayes, defying FDA advisors, approved aspartame for dry foods: his first major decision. In November 1983 the FDA approved aspartame for soft drinks: the last decision on Hayes's watch.
Also in November 1983, under fire for accepting corporate gifts, with the threat of an abuse of recruits charge from the Army inspector general looming, Hayes left the agency and went to Searle's public relations firm as senior medical advisor. Later, Searle lawyer Robert Shapiro named aspartame "NutraSweet." Monsanto purchased Searle. Rumsfeld received a $12 million bonus. Shapiro became Monsanto president.
Shortly after the FDA's July 1983 soft-drink approval, Searle began test-marketing aspartame drinks, and complaints of dizziness, blurred vision, headaches, and seizures began arriving at the FDA. The complaints were more serious than the agency had ever received on any food additive. At the same time, scientists began looking more closely at this manufactured chemical sweetener.
The Record of Damage Piles Up
In 1985, the FDA asked the Centers for Disease Control (CDC) to review the first 650 complaints (there are now over 10,000). The CDC found that the symptoms in approximately 25% of the complainants had stopped and then restarted, corresponding with their having stopped and then restarted aspartame consumption, either purposely or by accident. This finding suggests serious problems for some members of the population.
The FDA discounted the CDC's report. The day that the FDA released the CDC report, Pepsi (with an advanced copy of the confidential CDC report) announced its switch to aspartame with a worldwide media blitz, drowning out the CDC reports of aspartame harm. The Pepsi announcement and aggressive marketing (millions of gumballs, a red and white swirl, tough contracts) made NutraSweet known in every home. Still the damage reports rolled in.
Data released in 1995 showed that human brain tumors in the general population, like those in the animal studies, had risen 10% and previously benign tumors turned virulent. Searle and the FDA's deputy commissioner said the data posed no problem. Two years later this same FDA official became vice president of clinical research for Searle.
Aspartame has the largest market share of the $1.1 billion US alternative sweetener industry.
Current Cancer Science
In the early 21st century the European Foundation of Oncology and Environmental Sciences "B. Ramazzini" in Bologna, Italy presented new animal data suggesting that aspartame was a generalized carcinogen, at the very least involving haemopoietic and lymphoid organs and tissues. At the highest dose level tested in the Ramazzini study, 25% of female rats bore lymphomas-leukemias compared with 8.7% in the controls.
The foundation said:
"Because of the globalization of the industrialized diet and the ever-increasing use of artificial sweeteners among billions of people in both industrialized and developing countries, the European Ramazzini Foundation considers its work on sweeteners to be of the highest priority for the protection of public health, in particular the health of children and pregnant women who are among the most vulnerable populations."The National Institutes of Health (NIH), the FDA in the U.S., the European Food Safety Authority's Panel on Food Additives, Flavorings, Processing Aids and Materials (EFSA), and of course the NutraSweet Company all dismiss the new findings. Their most important claim is that human epidemiological studies do not show any difference in cancer rates between consumers and non-consumers of aspartame.
"In light of this goal," it continued, "and given the inadequacy of most of the previous carcinogenicity studies on artificial sweeteners, we have planned and are conducting additional research, not only on aspartame, but also on other widely diffused artificial sweeteners and blends used in thousands of foods, beverages and pharmaceutical products."
Increasing Demand
The Freedonia Group, a Cleveland-based research firm, reports that U.S. demand for alternative sweeteners in the past decade increased about 4 percent per year to $1.1 billion in 2009. Demand is projected to grow 3.4 percent annually through 2013.
Avoiding Aspartame/NutraSweet Makes Sense
Given the NIH conclusion, the danger warning of the experimental data was underlined by examination of studies done from 1985 to 1995. During that time researchers did about 400 aspartame studies, divided almost evenly between those that gave assurances and those that raised safety questions. Most instructively, Searle paid for 100% of those studies that found no problem. All studies paid for by non-industry sources raised questions.
NIH epidemiological studies are not laboratory studies. Populations are not individual people. The jury is still out on aspartame safety for various susceptible individuals. There is a pattern of potential harm in animal studies and human complaints that raise a red flag. Symptoms come and go as individuals use and stop using aspartame. If NutraSweet is harming people, it is doing so whether scientists know it or not.
Given this record, it is little wonder that many health-conscious people believe that avoiding NutraSweet improves their quality of life. If and when a scientific consensus concludes that aspartame puts some, if not all, of its consumers at risk, it will be much too late. The damage will have been done. The point is to eat safely now. There is no reason to risk the aspartame dangers complained about by so many individuals.
Read the Label
In the U.S. and Canada, foods and beverages that contain aspartame must include "contains phenylalanine" on the label. Be aware that products that contain MSG (monosodium glutamate) also bear a relationship to aspartic acid in aspartame. In the case of medications, look at both the active and inactive ingredients.
The Many Faces of Aspartame
Aspartame is also known as NutraSweet, Equal, Spoonful, Canderel, Benevia, and E951.
Leading aspartame manufacturer Ajinomoto announced in November 2009 that it would be rebranding its artificial sweetener as "AminoSweet" in Europe, the CIS, the Middle East and Africa. Ajinomoto has also developed a vanilla-flavored version of aspartame, called "advantame." Ajinomoto USA states that: "It is our expectation to obtain the U.S. approval [for the use of advantame in food from the FDA] within two years." Ajinomoto USA also "intend[s] to apply for [approval in] Australia/New Zealand and Europe."
Aspartame Alternatives
Alternatives to chemical or artificial sweeteners such as aspartame include: honey, maple syrup, turbinado sugar, fruit, fruit juice concentrates, and various forms of stevia (an herb).
Aspartame and Monsanto
NutraSweet made up an important part of the Monsanto Empire between 1985 and 2000. Here is a road map of how its ownership evolved:
The NutraSweet Company makes and sells NutraSweet, their trademarked brand name for the artificial sweetener aspartame, and Neotame.About the author
Robert B. Shapiro, who worked as an attorney for the Illinois-based G.D. Searle & Company from 1979, became CEO and Chairman of its NutraSweet subsidiary in 1982 where he remained until 1990. Monsanto bought Searle in 1985. When Searle was acquired by Monsanto, Shapiro moved up the management chain in the latter, becoming Vice President in 1990, President in 1993 and CEO in 1995. He remained CEO of Monsanto until 2000. Shapiro oversaw a period of industrial expansion and consumer regulatory approval for the genetically-engineered foodstuff corporation. In 2000 Monsanto merged with the Swedish pharmaceutical company Pharmacia, and Shapiro became chair of this entity until he stepped down in February 2001. In March 2000, Monsanto sold NutraSweet to the private equity firm J.W. Childs.
James S. Turner, Esq., is a partner in the 36-year-old Washington, D.C. consumer-interest law firm of Swankin and Turner. He is the author of The Chemical Feast: the Nader Report on Food Protection at the Food and Drug Administration, co-author of Making Your Own Baby Food, and author of a number of law and popular journal articles.
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