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"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. |