The FDA had actually banned aspartame based on this finding, only to have
Searle Chairman Donald Rumsfeld vow
to "call in his markers," to get it approved.
December 1965: While
working on an ulcer drug, James Schlatter, a chemist at G.D. Searle, accidentally
discovers aspartame, a substance that is 180 times sweeter than sugar yet
has no calories.
Spring 1967: Searle begins the safety tests on aspartame that are necessary for applying for FDA approval of food additives.
Fall 1967: Dr. Harold Waisman, a biochemist at the University of Wisconsin,
conducts aspartame safety tests on infant monkeys on behalf of the Searle
Company. Of the seven monkeys that were being fed aspartame mixed with milk,
one dies and five others have grand mal seizures.
November 1970: Cyclamate, the reigning low-calorie artificial sweetener --
is pulled off the market after some scientists associate it with cancer.
Questions are also raised about safety of saccharin, the only other artificial
sweetener on the market, leaving the field wide open for aspartame.
December 18, 1970: Searle Company executives lay out a "Food and Drug Sweetener
Strategy' that they feel will put the FDA into a positive frame of mind about
aspartame. An internal policy memo describes psychological tactics the company
should use to bring the FDA into a subconscious spirit of participation"
with them on aspartame and get FDA regulators into the "habit of saying,
Spring 1971: Neuroscientist Dr. John Olney (whose pioneering work with monosodium
glutamate was responsible for having it removed from baby foods) informs
Searle that his studies show that aspartic acid (one of the ingredients of
aspartame) caused holes in the brains of infant mice. One of Searle's own
researchers confirmed Dr. Olney's findings in a similar study.
February 1973: After spending tens of millions of dollars conducting safety
tests, the G.D. Searle Company applies for FDA approval and submits over
100 studies they claim support aspartame's safety.
March 5, 1973: One of the first FDA scientists to review the aspartame safety
data states that "the information provided (by Searle) is inadequate to permit
an evaluation of the potential toxicity of aspartame". She says in her report
that in order to be certain that aspartame is safe, further clinical tests
May 1974: Attorney, Jim Turner (consumer advocate who was instrumental in
getting cyclamate taken off the market) meets with Searle representatives
to discuss Dr. Olney's 1971 study which showed that aspartic acid caused
holes in the brains of infant mice.
July 26, 1974: The FDA grants aspartame its first approval for restricted use in dry foods.
August 1974: Jim Turner and Dr. John Olney file the first objections against aspartame's approval.
March 24, 1976: Turner and Olney's petition triggers an FDA investigation
of the laboratory practices of aspartame's manufacturer, G.D. Searle. The
investigation finds Searle's testing procedures shoddy, full of inaccuracies
and "manipulated" test data. The investigators report they "had never seen
anything as bad as Searle's testing."
January 10, 1977: The FDA formally requests the U.S. Attorney's office to
begin grand jury proceedings to investigate whether indictments should be
filed against Searle for knowingly misrepresenting findings and "concealing
material facts and making false statements" in aspartame safety tests. This
is the first time in the FDA's history that they request a criminal investigation
of a manufacturer.
January 26, 1977: While the grand jury probe is underway, Sidley & Austin,
the law firm representing Searle, begins job negotiations with the U.S. Attorney
in charge of the investigation, Samuel Skinner.
March 8, 1977: G. D. Searle hires prominent Washington insider Donald Rumsfeld
as the new CEO to try to turn the beleaguered company around. A former Member
of Congress and Secretary of Defense in the Ford Administration, Rumsfeld
brings in several of his Washington cronies as top management.
July 1, 1977: Samuel Skinner leaves the U.S. Attorney's office and takes a job with Searle's law firm. (see Jan. 26th)
August 1, 1977: The Bressler Report, compiled by FDA investigators and headed
by Jerome Bressler, is released. The report finds that 98 of the 196 animals
died during one of Searle's studies and weren't autopsied until later dates,
in some cases over one year after death. Many other errors and inconsistencies
are noted. For example, a rat was reported alive, then dead, then alive,
then dead again; a mass, a uterine polyp, and ovarian neoplasms were found
in animals but not reported or diagnosed in Searle's reports.
December 8, 1977: U.S. Attorney Skinner's withdrawal and resignation stalls
the Searle grand jury investigation for so long that the statue of limitations
on the aspartame charges runs out. The grand jury investigation is dropped.
June 1, 1979: The FDA established a Public Board of Inquiry (PBOI) to rule on safety issues surrounding NutraSweet.
September 30, 1980: The Public Board of Inquiry concludes NutraSweet should
not be approved pending further investigations of brain tumors in animals.
The board states it "has not been presented with proof of reasonable certainty
that aspartame is safe for use as a food additive."
January 1981: Donald Rumsfeld, CEO of Searle, states in a sales meeting that
he is going to make a big push to get aspartame approved within the year.
Rumsfeld says he will use his political pull in Washington, rather than scientific
means, to make sure it gets approved.
January 21, 1981: Ronald Reagan is sworn in as President of the United States.
Reagan's transition team, which includes Donald Rumsfeld, CEO of G. D. Searle,
hand picks Dr. Arthur Hull Hayes Jr. to be the new FDA Commissioner.
March, 1981: An FDA commissioner's panel is established to review issues raised by the Public Board of Inquiry.
May 19, 1981: Three of six in-house FDA scientists who were responsible for
reviewing the brain tumor issues, Dr. Robert Condon, Dr. Satya Dubey, and
Dr. Douglas Park, advise against approval of NutraSweet, stating on the record
that the Searle tests are unreliable and not adequate to determine the safety
July 15, 1981: In one of his first official acts, Dr. Arthur Hayes Jr., the
new FDA commissioner, overrules the Public Board of Inquiry, ignores the
recommendations of his own internal FDA team and approves NutraSweet for
dry products. Hayes says that aspartame has been shown to be safe for its'
proposed uses and says few compounds have withstood such detailed testing
and repeated close scrutiny.
October 15, 1982: The FDA announces that Searle has filed a petition that
aspartame be approved as a sweetener in carbonated beverages and other liquids.
July 1, 1983: The National Soft Drink Association (NSDA) urges the FDA to
delay approval of aspartame for carbonated beverages pending further testing
because aspartame is very unstable in liquid form. When liquid aspartame
is stored in temperatures above 85 degrees Fahrenheit, it breaks down into
DKP and formaldehyde, both of which are known toxins.
July 8, 1983: The National Soft Drink Association drafts an objection to
the final ruling which permits the use of aspartame in carbonated beverages
and syrup bases and requests a hearing on the objections. The association
says that Searle has not provided responsible certainty that aspartame and
its' degradation products are safe for use in soft drinks.
August 8, 1983: Consumer Attorney, Jim Turner of the Community Nutrition
Institute and Dr. Woodrow Monte, Arizona State University's Director of Food
Science and Nutritional Laboratories, file suit with the FDA objecting to
aspartame approval based on unresolved safety issues.
September, 1983: FDA Commissioner Hayes resigns under a cloud of controversy
about his taking unauthorized rides aboard a General Foods jet. (General
foods is a major customer of NutraSweet) Burson-Marsteller, Searle's public
relation firm (which also represented several of NutraSweet's major users),
immediately hires Hayes as senior scientific consultant.
Fall 1983: The first carbonated beverages containing aspartame are sold for public consumption.
November 1984: Center for Disease Control (CDC) "Evaluation of consumer complaints
related to aspartame use." (summary by B. Mullarkey)
November 3, 1987: U.S. hearing, "NutraSweet: Health and Safety Concerns,"
Committee on Labor and Human Resources, Senator Howard Metzenbaum, chairman.