Category: News & Opinion Topic: Government
Synopsis: How Rumsfeld manipulated FDA approval of ASPARTAME
Environment, Technology and Society Forum
Published: August 25, 2002 Author: James S. Turner
||For Education and Discussion Only. Not for
Rumsfeld's conflict of interests and ASPARTAME: Rumsfeld was president of
Serle corporation in 1977, maker of aspartame, then, part of Reagan
transition team, and got aspartame 'legalized' by appointing a defense
department contractor [??] (Hayes) as head of FDA!
A book should be written about American corruption and aspartame.
[Scroll down for material relating specifically to Rumsfeld, in
The Aspartame/NutraSweet Fiasco by James S. Turner
Many health-conscious people believe that avoiding aspartame, found in over
5000 products under brand names such as Equal and NutraSweet, can improve
their quality of life. The history of this synthetic sweetener's approval by
the U.S. Food and Drug Administration (FDA), including a long record of
consumer complaints and the agency's demonstrated insensitivity to public
concern, suggests they're right.
In October 1980 the Public Board of Inquiry (PBOI) impaneled by the FDA to
evaluate aspartame safety found that the chemical caused an unacceptable
level of brain tumors in animal testing. Based on this fact, the PBOI ruled
that aspartame should not be added to the food supply.
This ruling capped 15 years of regulatory ineptitude, chicanery and
deception by the FDA and the Searle drug company, aspartame's discoverer and
manufacturer (acquired by Monsanto in 1985), and kicked off another two
decades of maneuvering, manipulating and dissembling by FDA, Searle and
In 1965, a Searle scientist licked some of a new ulcer drug from his fingers
and discovered the sweet taste of aspartame. Eureka! Selling this chemical
as a food additive to hundreds of millions of healthy people every day would
mean many more dollars than limited sales to the much smaller group of ulcer
Searle, a drug company with little experience in food regulation, began
studies to comply with the law -- but which failed to do so. Its early tests
of the substance 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. But the agency also made public for the
first time the data supporting a food-additive decision. This data was
subsequently reviewed by renowned brain researcher John Olney from
Washington University in St. Louis, and other scientists.
Dr. Olney discovered two studies showing brain tumors in rats and petitioned
FDA for a public hearing. Consumer Action for Improved Foods and Drugs
(represented by the author of this piece) also petitioned for a public
hearing based on the approval process having been based on sloppy
science and the product's having reportedly caused epileptic seizures in
monkeys and possible eye damage.
Dr. Olney had already shown that aspartic acid (one aspartame component)
caused microscopic holes in the brains of rats after each feeding. Aspartame
also includes phenylalinine, which causes PKU in a small number
of susceptible children, and methyl, or wood, alcohol which is neurotoxic in
Faced with this array of possible health dangers, FDA granted the hearing
requests. In lieu of withdrawing its aspartame approval, the agency
prevailed on 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.
In July of 1975, as the FDA prepared for the PBOI, an FDA inspector
conducted a routine review of the Searle's Skokie Ill., testing facilities
and found many deviations from proper procedures. This report led the FDA
commissioner to empanel a Special Commissioner's Task Force to review
In December of 1975 the Task force reported serious problem with Searle
research on a wide range of products, including aspartame. It found
11pivotal studies conducted in a manner so flawed as to raise doubts about
aspartame safety and create the possibility of serious criminal liability
The FDA then stayed aspartame's approval. It also contracted, over serious
internal objection, with a group of university pathologists (paid by Searle)
to review most of the studies, set up a task force to review three studies
and asked the U.S. Attorney for Chicago to seek a grand jury review
of the monkey seizure study.
The pathologists paid by Searle only reviewed failure to properly report
data and not the study's design or conduct. They found no serious problems.
The FDA task force found Searle's key tumor safety study unreliable, but was
ignored. The U.S. attorney let the statue 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, the
petitioners and the FDA Bureau of Foods each nominated three members for the
board and the FDA commissioner selected one member from each list. the
board, which convened in January of 1980, rejected petitioners' request to
include the commissioner's task force information in its deliberations.
Still, in October 1980, based on its limited review, the board blocked
aspartame marketing until the tumor studies could be explained. Unless the
commissioner overruled the board, the matter was closed.
In November 1980, however, the country elected Ronald Reagan President.
Donald Rumsfeld (former congressman from Skokie, former White House chief of
staff, former secretary of defense and since January 1977 president of
Searle) joined the Reagan transition team. A full court press against the
board decision began.
In January 1981 Rumsfeld told a sales meeting, according to one attendee,
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, and the next month, the
commissioner's job went to Dr. Arthur Hull Hayes.
Transition records do not show why the administration chose ***Hayes, a
professor and Defense Department contract researcher.*** 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 --
Hayes' last decision.
In November 1983 Hayes, under fire for accepting corporate gifts, 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 is
now Monsanto president.
Shortly after the FDA soft-drink approval, Searle began test marketing, and
complaints began to arrive at the FDA -- of such reactions as dizziness,
blurred vision, headaches, and seizures. 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
In 1985, the FDA asked the Centers for Disease Control (CDC) to review the
first 650 complaints (there are now over 10,000). CDC found that the
symptoms in approximately 25% of the complainants had stopped and then
restarted, corresponding with their having stopped and then restarted,
either purposely or by accident, aspartame consumption.
The CDC also identified several specific subjects whose symptoms stopped and
started as they stopped and started consuming aspartame. The FDA discounted
the report. The day the FDA released the CDC report, Pepsi Cola -- having
obained an advance copy -- announced its switch to aspartame with a
worldwide media blitz.
Former White House Chief of Staff Rumsfeld owed a debt of gratitude to
former White House confidante and Rumsfeld friend Donald Kendal, Pepsi's
chairman. The Pepsi announcement and aggressive marketing (millions of
gumballs, a red and white swirl, tough contracts) made NutraSweet known in
At the same time, according to data released in 1995, human brain tumors
like those in the animal studies rose 10% and previously benign tumors
turned virulent. Searle and 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.
From 1985 to 1995, researchers did about 400 aspartame studies. They were
divided almost evenly between those that gave assurances and those that
raised questions about the sweetener. Most instructively, Searle paid for
100% of those finding no problem. All studies paid for by non-industry
sources raised questions.
Given this record, it is little wonder that many health-conscious people
believe 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 point is to eat safely now.
Remember: the brain you save may be your own.
James S. Turner, Esq., is a partner in the 27-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 the Food and Drug Administration, Making
Your Own Baby Food, and a number of law journal and popular media articles.
Edited by Aurelius on 04/26/03 10:52