Aspartame Information
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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