Sweetheart Deal

In 1970, James Turner, an attorney and current chairman of the board at the consumer advocacy organization Citizens for Health, learned of an amino acid that, when isolated and fed to laboratory mice, produced extreme neurological damage, essentially eating holes in the mice's brains. The substance, aspartic acid, is one of the three ingredients in aspartame, better known as NutraSweet.Three years later Turner learned that G.D. Searle, the maker of NutraSweet, had applied for FDA approval of aspartame. He approached the company with the scientific data."I said, 'Look, this thing causes holes in the brains of mice. What do you plan to do about that?'" Turner recalls. "They said, 'Nothing.'"Nothing is what the Food and Drug Administration did, too.The agency charged with safeguarding the U.S. food supply not only approved aspartame. In the years since it gave the sweetener the green light, the FDA has gotten so cozy with the NutraSweet industry that it has essentially disregarded its duty as sentinel. Call it the hen leaving the henhouse to work for the fox. Call it a revolving door. No matter what you call it, there's no doubt that something is amiss when FDA officials routinely leave their jobs to draw big paychecks at the companies they've just been regulating.This summer saw the 11th high-ranking federal official who worked on the aspartame case go to work for a company involved in making or selling the artificial sweetener (see sidebar). This despite a good deal of evidence that NutraSweet may pose serious health risks to people as well as mice.Consider: in 1996 the Journal of Neuropathology & Experimental Neurology published a report suggesting that the recent rise in the incidence of glioblastoma brain tumors may be due to the prevalence of aspartame in the American diet. It did not establish an incontrovertible cause-and-effect relationship -- a rarity in any field of medical research -- but the study nonetheless raised serious concerns among researchers and consumer advocates about the safety of the nearly ubiquitous artificial sweetener.Michael Friedman, the FDA deputy commissioner who handled the ensuing flak, remained steadfast in his defense of aspartame. He refused to appoint an independent investigator or board to look into the allegations. In the wake of the study's publication, a 60 Minutes investigation aired in December 1996 and highlighted the "at best, sloppy" work that went into preapproval testing of aspartame -- and the stonewalling that came after approval. (The quote comes from no less an authority than a former FDA commissioner.)Of the eight scientists, doctors, policy-makers and heads of industry who appeared in the 60 Minutes report, only two insisted that, despite all the evidence presented in the program, aspartame is still unquestionably safe: Friedman and a public relations officer from Monsanto. (Monsanto owns G.D. Searle, the company that makes NutraSweet.)In July of this year Friedman announced that he was leaving his position at the FDA to begin work as senior vice president of clinical affairs at . . . G.D. Searle.The FDA approved aspartame for use in dry goods on July 26, 1974. Turner and Dr. John Olney -- the scientist who conducted the study that found holes in the brains of mice fed aspartic acid -- immediately filed a formal objection to the approval and the FDA convened a board of inquiry a year later. The FDA stayed its approval after hearing from Turner and Olney, and after its own investigation of G.D. Searle turned up rampant and willful misrepresentations by the company in presenting its case to the FDA. (The U.S. attorneys assigned to bring charges against G.D. Searle let the statute of limitations run out, then quit their jobs and went to work for G.D. Searle's law firm.)In early 1977, G.D. Searle hired Donald Rumsfeld, fresh from his tenure as President Ford's chief of staff, as its CEO. Rumsfeld, in turn, hired the former spokesman for the Gerald Ford White House and two former Department of Transportation officials, including Robert Shapiro, the current CEO of Monsanto."This is a political, Washington-based group that used politics from here on out to deal with this issue," Turner says. "The big picture is that this thing got on the market through political corruption."In 1987, when U.S. Senator Howard Metzenbaum, D-Ohio, chaired a panel to consider the mounting health and safety concerns regarding aspartame, he summed up the case against the food additive as follows:* "The FDA has received close to 4,000 consumer complaints, ranging from seizures to headaches to mood alterations. Studies and letters in the medical journals have warned of possible neurological and behavioral effects in humans, particularly in children and susceptible individuals."* "Dr. Richard Wurtman of MIT has warned of a potential link to seizures."* "Dr. William Partridge of UCLA has raised concerns about excessive consumption by children."* "Dr. Michael Mahalik at the Philadelphia College of Osteopathic Medicine warns of the possibility of brain dysfunction."* "Dr. Reuben Matalon at the University of Illinois has warned about potentially dangerous long-term effects on learning ability."* "Dr. Jeffery Bada, a professor of chemistry at the University of California, states that NutraSweet's decomposition products have not been adequately studied."* "Dr. Roger Colombe of Utah State has cited NutraSweet's possible behavioral and neurological effects and called for new research."In the dozen years since Senator Metzenbaum spelled out the case against aspartame, the number of complaints against aspartame registered with the FDA has swelled to 10,000 and the docket of research raising questions about aspartame's safety has grown to nearly 100 studies.As Turner is quick to point out, whether 90 percent or 10 percent of the above studies are accurate, the questions raised so far are already sufficient cause to go back and reconsider NutraSweet's original FDA approval."There's nothing in the law that requires people raising questions to show causal connections," Turner says. "The other side has to show that [NutraSweet] didn't cause [problems]. And they've never tried to show that it didn't. There are probably 15 parameters for potential harm from NutraSweet. For each parameter you set up a protocol of science that says, 'Here's what you do scientifically to establish safety.' You'd put a question to the scientific group, for instance: 'Does NutraSweet cause cancer?' That has never been done with NutraSweet. On cancer, on seizures, on eye damage. That's never been done. In every one of the areas there has been a beginning. And every single one of the beginnings has raised a question."Dr. Robert Moser is a New Mexico cardiologist and longtime defender of aspartame. His staunch belief in the product over the years -- and his job as a full-time consultant to NutraSweet from 1986 to '91 -- have earned him the moniker "the NutraSweet Doctor."Moser's support of the sweetener is at times a rote recitation of chemical formulas, research results and papers published in what he calls "the good, peer-reviewed journals." His knowledge of statistical data and arcane facts in the aspartame case is impressive. But his defense of the additive is ultimately founded on very elemental facts. Aspartame is composed of three chemicals, all of which are found in nature: two amino acids and methanol, a naturally occurring alcohol."What gets into the body are the same elements that you get from eating fish, fowl, vegetables," Moser says. "And the amounts are so infinitely small that the body handles it very rapidly. So within four to six hours, even after a massive dose of aspartame, you cannot detect these in the bloodstream. They are already utilized and, in the case of the methanol, rapidly metabolized and excreted as carbon dioxide and water. There are no long-term effects because it'd be the same long-term effects as if you ate meat or fish or vegetables. That's why there's no possibility of any long-term toxicity."Aspartame's critics say that reasoning is deceptive. Once inside the body, they argue, aspartame acts nothing like the proteins in meat or fish or vegetables, or like the methanol found in, say, apple juice. The methanol in aspartame breaks down into formaldehyde and formic acid -- the same poison that's in an ant sting. What's more, the two amino acids that make up 90 percent of aspartame -- aspartic acid and phenylalanine -- have been found to act very differently than they do when contained in meat or fish or vegetables. In his 1994 book Exitotoxins: The Taste that Kills, Medical University of Mississippi associate professor of neurosurgery Dr. Russell Blaylock writes that aspartic acid and phenylalanine have been blamed for neurological damage by overexciting some of the brain's neurotransmitters literally to death.Moser, on the other hand, says the scientific studies are all indisputably in favor of aspartame's safety. "Before I ever joined NutraSweet, I spent my life taking care of patients, teaching students, teaching residents," he says. "And when I was offered the job [in 1986], I took off literally three months to study the literature on aspartame. I went to the National Library of Medicine and I pulled about 160 articles. I had about 100 of them photocopied and off and on when I was in semiretirement I read them. And there was no question in my mind, after reading that, that aspartame is safe."He keeps up with the latest research and says his position has not changed.There is a marked difference between the conclusions of studies funded by G.D. Searle/Monsanto/NutraSweet and those funded by independent institutions. In 1994, Dr. Ralph G. Walton of the Northeastern Ohio University College of Medicine did a survey of the scientific literature -- 164 research papers in all -- and found that every one of the 74 studies funded by the NutraSweet industry found no problem with the additive. But of the 90 studies that received no money from aspartame's corporate backers, 83 identified potential medical problems associated with consuming aspartame.As Upton Sinclair once said: "It is difficult for those to see whose paycheck depends on them not seeing."Moser, who still consults for NutraSweet on a part-time basis, disagrees."The fact is you go to these [researchers] and say, 'Look, someone has said that aspartame may cause headaches.' We went to Dr. Schiffman at Duke and said, 'Look, will you do a randomized, double-blind, placebo-controlled study that can be published in a peer-reviewed journal that has sufficient statistical basis that it will be accepted for publication?' She did. She went ahead and she did a 40-patient study at Duke that was published in 1987. And she found that aspartame does not cause headaches."Now, she and her group wrote the protocol. The protocol was reviewed by their own institutional review board. The article was written. It was submitted to the New England Journal of Medicine. The editors and the referees of the New England Journal of Medicine reviewed the article. And it was published. Now, the granting agency, the NutraSweet company, had absolutely nothing whatsoever to do with that study. They didn't have anything to do with the institutional review board. They didn't have anything to do with the editors and referees of the New England Journal of Medicine. And that's the way this good research has been done. It's been done at probably 30 different medical schools and their hospitals across the world. They're excellent, good studies published in peer-reviewed journals."As far as Janet Starr Hull is concerned, all the kings horses and all the kings men can publish their studies in every prestigious medical journal in the galaxy. She says she knows what caused her deadly degenerative neurological disorder -- Graves disease -- and she knows that when she eats aspartame her symptoms return. (Against such evidence, Moser cites a paper by Dr. Raif Geha at Harvard, who studied 21 people who said they suffered from aspartame poisoning: two of them, when fed a placebo, claimed a return of symptoms and one even required hospitalization.)Hull, a Texas-based geologist, environmental engineer and certified nutritionist who now studies the effects of toxins in the water supply, published a general-interest book earlier this year, Sweet Poison, hoping to raise awareness about Monsanto's artificial sweetener, which is now found in over 5,000 foods and beverages."I've talked to so many people whose children are deformed and mentally retarded from aspartame -- when they used it during pregnancy and they've been giving it to their kids since they were infants," she says. "When they come to me they say, 'The doctors have never been able to help me.'"As soon as these people get this information they stop using the aspartame. And their symptoms and their problems go away. That's why I'm saying that people have the right to a good opinion, whereas the medical community and the pharmaceutical companies will tell you, 'Oh look, you're not a doctor. You can't give us an opinion on this.' Well that's wrong. They can. Because they know their bodies and they know their children's bodies."Mary Nash Stoddard is one of the pioneers of the anti-aspartame movement. She founded the Aspartame Consumer Safety Network in Dallas in 1987 after her husband died of a brain tumor, her daughter suffered a grand-mal seizure and she herself came down with a potentially deadly blood disorder and motor-skill problems. Although she doesn't blame her husband's death entirely on aspartame, she believes her own and her daughter's problems were brought on by the additive.She recalls the response she got from the FDA when she reported these reactions: "I got this real cheerful person on the phone who said, 'Oh no, I'm drinking the diet drink right now. It couldn't hurt you. It couldn't hurt your daughter. Just keep on giving it to her. [It's like] bananas and milk. It's safe as the pure driven snow.'"Stoddard now devotes her time to raising awareness about aspartame and claims three out of five aspartame users she communicates with have at least experienced aspartame-related headaches. She has also established the Worldwid e Pilot's Hotline, an aspartame information clearinghouse for airline professionals (214-352-4268). She founded the organization because studies have shown that aspartame's neurological effects can be exacerbated at high altitude.Anti-aspartame fervor is now being felt in high places. In July, Monsanto announced that it was divesting itself of its NutraSweet division. That decision, Stoddard argues, stems from the rising tide of public concern about the additive."Obviously a corporation would not ever think of divesting itself of a money-making, successful venture or division," she says. "So we believe we are having a very profound impact on the profit margin of the company."Ultimately, however, Hull and Stoddard both blame not Monsanto or G.D. Searle or NutraSweet. They blame the FDA.Turner says the lesson of aspartame is that FDA approval should not be viewed by consumers as a stamp of safety. "If you do anything because the government tells you it's OK to do it, you're fooling yourself. The government says cigarette smoking's fine. Yeah, sure, go ahead. No problem."The controversy, he says, centers on the widespread misuse of one word: "safety." "The debate about NutraSweet is a subset of the whole debate about food safety, which is a subset of the whole debate about the interconnection between science and law. There's a whole debate that goes on in the scientific realm. And there's a whole debate that goes on in the policy realm. They're disconnected. And this word 'safety' is used as kind of a little transmitter that allows people to think they're talking about the same thing when they're not."As Hull points out, the financiers of the next generation of food additives -- such as the fat substitute Olestra -- have learned their lesson from the aspartame experience."The corporations are being a lot more lock-and-key with their information," she says. "That is very scary. There's an incredible amount of money backing the corporate science. And when you're a little guy, just a consumer, how are you going to stand up against that?"***SIDEBAR: Sugar DaddyFood-industry observers have a joke about today's Food and Drug Administration. They call it Monsanto's Washington office.But the history of aspartame (which is made by G.D. Searle, a division of Monsanto) is more laughable than it is funny.Eleven high-ranking government officials closely tied to the approval and subsequent defense of aspartame have since gone on to take jobs in the NutraSweet industry.* In April 1977, U.S. Attorney Samuel Skinner was urged in a memo from the Department of Justice to proceed with fraud indictments against G.D. Searle for gross misconduct in presenting the argument for NutraSweet to the FDA. The memo noted that the statute of limitations on the case was running out. In July of that year Skinner quit and went to work for Sidley & Austin, G.D. Searle's law firm.* Assistant U.S. Attorney William Conlon took over the case and did convene a grand jury. He later allowed the statute of limitations to run out and 15 months after that went to work for Sidley & Austin.* After hearing objections to aspartame, the FDA stayed its approval of the additive. H.R. Roberts, director of the FDA's Bureau of Foods, convened a task force to review claims against aspartame in 1977 -- which one senior scientist on the task force described 10 years later as "a whitewash." The following year Roberts took a job as vice president of the National Soft Drink Assoc.* After an unsuccessful bid in the late '70s, G.D. Searle reapplied for FDA approval of aspartame the day after Ronald Reagan was inaugurated. G.D. Searle CEO Donald Rumsfeld served as a key member of Reagan's transition team.* In April 1981, Reagan appointed Arthur Hull Hayes Jr. FDA commissioner. Though an internal scientific review board recommended that aspartame not be approved, Hayes approved aspartame for use in dry goods that year. After he approved aspartame for use in soft drinks in 1983, Hayes left the FDA to take on a reported $1,000-a-day consulting arrangement with G.D. Searle's public relations firm, Burston Marsteller.* Between 1979 and 1982 four FDA officials involved in aspartame's approval were hired by NutraSweet or organizations closely affiliated with NutraSweet: Mike Taylor, the FDA lawyer who represented the agency in public hearings on aspartame in 1977; acting FDA Commissioner Sherwin Gardner; Albert Kolbye, associate director of the FDA's Bureau of Foods; and Stuart Pape, chief counsel for the Department of Health and Human Services from 1976 to '79.* When new data was released suggesting a link between aspartame and brain cancer, deputy FDA Commissioner Michael Friedman insisted that aspartame is still safe and refused to consider investigating any further. In July 1999, Friedman went to work as senior vice president of clinical affairs for G.D. Searle.Mark K. Anderson is an investigative reporter whose work has appeared in Harper's magazine, among other publications.

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