> Nutrapoison Part Two

> by Alex Constantine

> At the FDA, Hayes used aspartame as a political statement that the Reagan administration was embarking on a grand voyage of conservative "regulatory reform," sluicing through treasonous liberal constraints on "free enterprise." Despite what one FDA scientist described as 'very serious' questions concerning pivotal brain tumor tests, Hayes eagerly approved aspartame for use in dry foods in July 1981.39 Three FDA scientists advised against the approval of aspartame, citing G.D. Searle's own brain tumor tests, because there was no proof that "aspartame is safe for use as a food additive under its intended conditions of use. "40

> Hayes has since declined to answer any questions about his decision, which ignored the recommendations of the FDA's own board of inquiry. He relied instead on a study conducted by Japan's Ajinomoto, Inc.-a licensee of G.D. Searle. Hayes acknowledged in his 1981 decision that he had only consulted a preliminary report of the Japanese evaluation, and only *skimmed* it. More serious, Hayes violated federal law by basing approval on the test, as it had not been reviewed by the FDA board.41

> Who is Arthur Hull Hayes? He was no disinterested bureaucrat. True to the biochemical theme of the aspartame story, Dr. Hayes served in the Army Medical Corps in the 1960s. According to the _Washington Post_, Hayes was assigned to Edgewood Arsenal at Fort Detrick, Maryland, the Army's chemical warfare base of operations, "one of a number of doctors who conducted drug tests for the Army on volunteers . . . to determine the effect of a mind-disorienting drug called CAR 301,060." According to a declassified 1976 report prepared by the Army Inspector General, Hayes had planned a research study to develop the mind-altering CAR 301,060 as a *crowd control agent.* In 1972, Hayes left Edgewood Arsenal, and a new plan for the experiments was drawn up by Edgewood physicians. The 1976 report notes that similar tests had been conducted before Hayes took charge. 42

> Also at the center of the effort to land FDA approval of NutraSweet stood Donald Rumsfeld-"Rummy" to his friends -chairman of G.D. Searle upon leaving the Ford administration in 1977. Rumsfeld, the product of a wealthy Chicago suburb, was a Princeton graduate and a Navy pilot during the Korean conflict. He entered politics as a Congressional House aide attending night classes at Georgetown University Law School, which is closely aligned with the CIA.43

> Rumsfeld campaigned ambitiously for Richard Nixon, who drafted him to direct the Office of Equal Opportunity on May 26,1969. He quickly established an office to spy on his employees in a holy crusade to flush out "revolutionaries" said to be granting federal funds to politically subversive organizations-a throwback to McCarthy's tantrums.44 Rumsfeld also figured in Nixon's notorious Power Control Group, spearheaded by Charles Colson and John Ehrlichman.45 Gerald Ford named Rumsfeld executive chief of staff upon the resignation of Al Haig. In 1986 he was named chairman of the Institute for Contemporary Studies, a neoconservative "think tank" (read: propaganda mill) established in 1972 by Edwin Meese and Caspar Weinberger. ICS has sponsored such opinion-shaping projects as a study of expansions in "entitlement programs" and their erosive effects on the economy, and a book on the uses of coercion by Communist regimes.46 Rumsfeld, at 43, became the county's youngest secretary of defense. For many years he has been a vocal proponent of chemical weapons.47 He is chairman of the Rand Corp.48 In 1988, he dropped a presidential bid, and was named a v.p. of Westmark Systems, led by past NSA Director Bobby Ray Inman. Rumsfeld was one of Westmark's founding directors, sharing the board with Joseph Amato, a former vice president at TRW (and a colleague of Inman's at the National Security Agency), and Dale Frey, chairman of the General Electric Investment Corp.49

> Rumsfeld, a veteran political operative, was an adept at the vulgar art of public relations. He was recruited by G.D. Searle because he had "a Boy Scout image," according to one company official.50 A house politician was precisely what Searle needed to compensate for the damage done by independent researchers concerned about the toxic effects of aspartame. In March 1976, an FDA task force brought into question *all* of the company's testing procedures between 1967 and 1975. The task force described "serious deficiencies in Searle's operations and practices which undermine the basis for reliance on Searle's integrity." The final report of the FDA task force noted faulty and fraudulent product testing, knowingly misrepresented findings, and instances of "irrelevant or unproductive animal research where experiments have been poorly conceived, carelessly executed or inaccurately analyzed."51

> Richard Merrill, the FDA's chief counsel, petitioned Samuel K. Skinner U.S. Attorney for the northern district of Illinois, for a grand jury investigation of Searle's "willful and knowing failure" to submit required test reports, and for "concealing material facts and making false statements" in reports on aspartame submitted to the agency.52 Yet industry analysts, interviewed by the _Wall Street Journal_ six months after Rumsfeld's appointment as chairman, noted a rapid turnabout in Searle's fortunes as a result of his direction.53

> Searle denies that Chairman Rumsfeld ever had any contact with the FDA, or the Carter and Reagan administrations, to lobby for aspartame.54 But the _Wall Street Journal_ article reported in 1977 that Rumsfeld "keenly understands the importance of a public image. So he has been mending fences with the FDA by personally asking top agency officials what Searle should do to straighten out its reputation." Westley M. Dixon, Searle's vice chairman, told the _Journal_ that without Rumsfeld "we wouldn't have gotten approval for Norpace," a drug investigated by the FDA in 1975.55

> The grand jury investigation of Searle disintegrated in January, 1977 when the FDA formally requested that Samuel Skinner, U.S. attorney and a protege of Illinois Governor James Thompson, investigate the firm for falsifying and withholding aspartame test data. A month later, Skinner met with attorneys from Searle's Chicago law firm, Sidley & Austin. Jimmy Carter ascended to The presidency a few weeks later. He announced that Skinner would not be asked to remain in office, but the outgoing Republican wasn't found wanting for employment. He informed reporters that he had already begun "preliminary discussions" with Sidley & Austin.56

> G.D. Searle and Sidley & Austin are Siamese Twins. Edwin Austin, a senior partner in the law firm, was appointed to the Illinois Supreme Court in 1969. The Searle family drew upon his services extensively, and he taught Sunday school in Wilmette, a Chicago suburb, as did Dr. Claude Howard Searle, whose father cofounded the pharmaceutical house.

> The firm is grafted to the beating heart of the Republican party. Morris Leibman of Sidley & Austin was for many years chairman of the American Bar Association's "Standing Committee on Law and National Security," a position that won him Reagan's Medal of Freedom in 1981.57

> John E. Robson, head of Sidley & Austin's Washington office, was appointed executive vice-president of Searle & Co. in 1977, the same year Skinner was named a partner in the law firm. Robson, too, was active in Republican politics. He was the first General Counsel of the Department of Transportation, and at the behest of Gerald Ford in 1975, chairman of the Civil Aeronautics Board.58 He moved on to Searle, and stayed with the company until it was bought outright by Monsanto in 1985. Howard Trienens, a law clerk to the late chief Justice Vinson in the early 1950s, was a G.D. Searle director and worked for Sidley & Austin since 1949.59 Archconservative California Governor George Deukmejian joined Sidley & Austin's Los Angeles branch upon leaving office in 1991, and is reportedly making a "very comfortable" living. He has a keen "sense" for bringing in corporate clients, a partner in the firm told the Los Angeles Times, many of them past contributors to his campaign fund. Deukmejian's business connections have given him a reputation as a Sidley & Austin "rainmaker," but the L.A. City Council has questioned his ethics in promoting a contract with Sumitomo Corp. on a metropolitan railway project.60 Searle aside, Sidley & Austin has served some of the most notorious special interests in the country. The firm lobbied overtime, for instance, on behalf of Charles Keating's Lincoln Savings & Loan, and provided counsel on tax issues and dealing with federal authorities. The firm assisted Keating when Lincoln was foundering, and curried political favor to keep the S&L operating despite massive debts. As a result, the firm was forced to settle with Lincoln depositors in 1991, agreeing to cover an excess of $40 million in claims.6l Sidley & Austin also represented the AMA when a group of drugstore chains sued seven drug makers-including Searle-for price fixing and antitrust violations. The lawsuit, filed in October 1993, amounts to billions of dollars in compensation.62

> Skinner recused himself from the Searle prosecution four months before leaving offtce-asking, in a memo to subordinates, that the matter be kept "confidential to avoid any undo embarrassment"-a stall that nearly allowed the statute of limitations to expire. William Conlon, a senior U.S. attorney, inherited the case. He eased off, citing case load pressures, and gave a deaf ear to complaints of delays from the Justice Department, which urged that a grand jury be convened to prosecute Searle for falsifying NutraSweet test data. In January, 1979, Conlon too joined Sidley & Austin.63

> The 33-page letter from Merrill to Skinner charged Searle with criminal fraud in its animal test results. In 1984 Common Cause asked Dan Reidy of the U. S. attorney's office how the investigation had stalled. Reidy replied that because it was a grand jury investigation, he was "bound by law to secrecy." A Searle spokesman exploited the demise of the grand July claim that there was "no validity to the charges, that the company had been "exonerated." Philip Brodsky, an investigator for the FDA, expressed surprise that Searle hadn't been indicted. "I thought surely they would prosecute them," he said.64

> Eleven years later Senator Metzenbaum issued a press release charging Skinner with stalling the criminal investigation as he prepared to decamp from office. Metzenbaum and his staff demanded an FBI investigation of Skinner's mishandling of the case. In December 1988, the conflict-of-interest bombshell blew up in the face of newly elected George Bush, who was about to appoint Skinner to the position of Transportation Secretary.65

> Like most of the Machiavellians in the NutraSweet story, Samuel Knox Skinner kept company with hardright Republicans. He entered politics as a campaign volunteer for Barry Goldwater. 66 In 1975, he was appointed to Federal Prosecutor in Chicago by President Ford. Sidley & Austin promoted him to senior partner after only one year with the firm. Skinner was the director of George Bush's presidential campaign in Illinois. On occasion he was berated for his involvement with the state's Republican apparatus: In 1987, for instance, the Chicago SunTimes linked him with a clutch of lawyers close to Governor Thompson, who were awarded lucrative assignments handling the affairs of financially crippled insurance companies. Skinner was a leading light of the Illinois Fraud Prevention Commission -he targeted welfare cheats (as opposed to white-collar criminals in the drug industry)-and President Reagan's Commission on Organized Crime. In December 1991, he left Transportation to take the position of President Bush's Chief of Staff.67

> "A Shocking Story"

> Had Skinner pressed on with the investigation, aspartame's manufacturer would have been forced to explain a long history of fabricated laboratory tests and slippery dealings with federal regulators, not to mention the public.

> Dr. Alexander Schmidt, a former FDA commissioner, said of the original Aspartame Task Force investigation: "What was discovered was reprehensible. . .incredibly sloppy science." A 1980 public board of inquiry opined that the company's testing procedures were "bizarre."68

> Searle's decision to market aspartame culminated with the falsification of test results to obtain FDA approval . In November 1969, officials of the firm hired Dr. Harry Waisman, a researcher for the University of Wisconsin, to test for brain damage in rhesus monkeys. Seven monkeys were fed aspartame for periods up to one year. In the end, though, the evaluation flopped because the technicians failed to perform the intelligence tests and autopsies required to determine brain damage. When questioned about the false data by the FDA, Searle officials claimed to have had no direct control over the study. But the protocol for the study was written by a Searle pathologist *after* it had begun. And, according to Dr. Gross, "Frequent high-level communications took place between Searle executives and Dr. Waisman prior to and during the study." 69

> To make matters worse, Dr. Waisman died in March, 1971, in mid-study.

> Searle submitted the toxicity test to the FDA on October 12, 1972. It bore Dr. Waisman's name as coauthor. Richard Merrill noted: "Dr. Waisman was the expert in the field and his name would carry great weight," but complained to Skinner that Searle took "great literary license" in drafting the report, "which *covers up* the admitted inadequacy of the design, control and documentation of this study." 70

> Searle submitted some 150 test reports, yet Dr. Martha Freeman of the FDA Bureau of Drugs noted in a 1973 memo, "the information provided is inadequate to permit an evaluation of the potential toxicity of aspartame." 71 The FDA task force set up by Dr. Schmidt in 1975 reviewed 25 studies on seven products manufactured by G.D. Searle, a total of 500 pages and 15,000 exhibits.72 Searle was held to be the author of "reports that the FDA believes contain false information" and "concealed facts resulting from having drafted Dr. Waisman's 'pilot' monkey study so that it would *appear* to be a valid, thorough scientific study," and not a forgery.

> In 1975 Searle submitted a battery of cancer test results entitled "The Willigan Report, which contained a statistical table that excluded four malignant mammary tumors detected by Dr. Willigan and incorporated in his data. The malignancies were made to appear benign. Searle dismissed the misrepresentation as a computer "programming error" undetected by supervising statisticians. Dr. Gross interviewed all concerned with the tests. He concluded in a statement to Metzenbaum's committee in August, 1985, that "to accept the Searle explanation is to believe that the unfavorable mammary malignancy data were innocently omitted from the summary table four separate times by three different individuals."74

> The Waisman and Willigan Reports were prepared by Searle Labs, as were 88% of the safety evaluations conducted by 1981.75 They are typical of the shoddy documentation upon which FDA Commissioner Hayes based his decision that aspartame does not constitute a public health risk. Although two members of the 1975 task force considered the tests to be criminal frauds, Hayes and Searle declared the results valid. In an appeal to Hayes' decision, James Turner said: "The entire argument that since the studies are no longer considered fraudulent *by FDA* they are therefore scientifically valid is an example of a rhetorical shell game that, if successful, can only bring discredit and ridicule on the FDA."76

> Dr. Gross, the chief scientist on the FDA task force, told the CBS *Nightly News* staff in January, 1984, that Searle made "*deliberate* decisions" to cloak the toxic effects of aspartame. "They took great pains to camouflage these shortcomings of the study,'' Gross said, "as I say, filter and just present to the FDA what they wished the FDA to know. And they did other *terrible* things. For instance, animals would develop tumors while they were under study-well, G.D. Searle would *remove these tumors from the animals*," surgically masking the cancerous effects of aspartame.77 Yet one 1986 _New England Journal of Medicine_ article claimed that noncompulsive aspartame intake has "no sinister effects."

> Dr. Woodrow Monte told CBS, "Every time a truly impartial team of scientists have looked at NutraSweet, it has been turned down." Dr. Monte, director of the nutrition laboratory at Arizona State University, held that these studies "show *extreme* dangers over the long term."78

> Dr. Monte was rewarded for his comments by a fusillade from the press. On February 23, Dan Dorfman, a business news reporter for WCBS in New York, broke a story that several CBS employees had invested in options on NutraSweet that pay off if the stock price drops.79 Dr. Monte and his attorney had purchased the options as well. It emerged that the CBS staffers had purchased the options on the advice of stock market newsletters printed prior to the nightly news report. The investments were not illegal, nor did they reap a profit. Searle's stock was not affected by the publicity, and the investors took a loss.

> Nevertheless, the _Wall Street Journal_ ran a front-page story condemning the "inside trading." Reed Irvine's Accuracy in Media picked up the cudgel against Dr. Monte and the CBS employees as if they'd committed a shocking Wall Street swindle.80 Accuracy in Media, formed in 1969, is an intelligence operation abetted by the CIA. The rabidly right-wing organization was co-founded by Bernard Yoh, a counter-insurgency adviser under the notorious Edward Landsdale in Vietnam, and a fount of CIA funds to military intelligence units in the Delta region. Board member Elbridge Durbrow was once a foreign service "diplomat," and advised commanders of Maxwell Air Force Base in Alabama. Another AIM board member, Frank Trager, has conducted research for the Pentagon and CIA, and churns out pamphlets on international business and intelligence operations. Major financial contributors to AIM include Richard Nixon, "Bebe" Rebozo, Edward Scripps, the wretched Dr. Edward Teller and former Treasury Secretary William E. Simon.81

> Accuracy in Media is a strident advocate of the chemical industry, which provides it with generous funding. The media "watchdog" has long waged a campaign on behalf of dioxin, denouncing the "Agent Orange scare" as the creation of delirious, anti-business liberals. Among the leading manufacturers of Agent Orange for the Vietnam war effort was Monsanto, preparing-at the very moment AIM took aim at detractors of NutraSweet[TM]- to buy G.D. Searle.

> The Good Stuff

> Dr. Monte cautioned in 1987 that he didn't want to sound like a "conspiracy theory" hound, but the aspartame chronology clarifies its commercial emergence. The FDA Board of Inquiry advised against the sweetener on September 30, 1980. On January21, 1981-the day after Reagan's inauguration-Searle submitted "ten new studies." Dr. Monte was skeptical. "It is impossib1e that they could have conducted those studies in four months," he said. "Obviously they'd previously done those studies but hadn't officially submitted them, although much of the information in those studies was informally presented to the board of inquiry." With the "new tests" in hand, Hayes acted as though critical, overriding evi dence had proven the safety of aspartame.82

> James Turner, representing thc Community Nutrition Institute in Washington, D.C., said that Arthur Hull Hayes, to arrive at his decision that aspartame is safe, firewalked apath "through a mass of scientific mismanagement, improper procedures, wrong conclusions and general scientific inexactness." Two FDA officials declared in 1985 that Hayes was determined to clear all obstacles to NutraSweet approval. One FDA bureaucrat reported that "people at the top" were closed to questions concerning the quality of the tests submitted by Searle.83

> In July, 1984 a broad investigation of NutraSweet's adverse effects was conducted by the FDA and the Centers for Disease Control. Federal health officials said at the outset that they believed no harm would emerge from the data to indict aspartame. Robert McQuate, Ph.D., science director of the National Soft Drink Association, predicted with mystical confidence that the study would "provide further evidence that aspartame is a safe ingredient."84

> Dr. McQuate didn't fret the goring of his biochemical ox. In November the CDC announced that no "serious, widespread" side effects had been found.85 It was "unlikely," said CDC officials, that "complainers" could establish a link between NutraSweet and their maladies-the same bromide once tossed to victims of radiation experiments. The reported side-effects of aspartame fell into two distinct categories: central nervous system (65%) and gastrointestinal disorders (24%).86 Yet the CDC claimed erroneously that no consistent reaction pattern had been found. 87 Robert Shapiro, then president of Nutrasweet, used the occasion to enthuse that the survey "clearly established the safety" of the sugar substitute.88 Nevertheless, the CDC recommended a new set of studies because aspartame users continued to complain of ill effects.

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