- From Norfolk Genetic Information Network (Taken from
Welcome to the Spin Machine by Michael Manville http://www.freezerbox.com/archive/2001/04/biotech/
- In 1985 Monsanto purchased G.D. Searle, the chemical
company that held the patent to aspartame, the active ingredient in NutraSweet.
Monsanto was apparently untroubled by aspartame's clouded past, including
a 1980 FDA Board of Inquiry, comprised of three independent scientists,
which confirmed that it "might induce brain tumors."
- The FDA had actually banned aspartame based on this finding,
only to have Searle Chairman Donald Rumsfeld (currently the Secretary of
Defense) vow to "call in his markers," to get it approved.
- On January 21, 1981, the day after Ronald Reagan's inauguration,
Searle re-applied to the FDA for approval to use aspartame in food sweetener,
and Reagan's new FDA commissioner, Arthur Hayes Hull, Jr., appointed a
5-person Scientific Commission to review the board of inquiry's decision.
- It soon became clear that the panel would uphold the
ban by a 3-2 decision, but Hull then installed a sixth member on the commission,
and the vote became deadlocked. He then personally broke the tie in aspartame's
favor. Hull later left the FDA under allegations of impropriety, served
briefly as Provost at New York Medical College, and then took a position
with Burston-Marsteller, the chief public relations firm for both Monsanto
and GD Searle. Since that time he has never spoken publicly about aspartame.
- The Aspartame/NutraSweet Timeline
- http://www.swankin-turner.com/aspartame.html http://www.swankin-turner.com/hist.html
- Aspartame/NutraSweet: The History of the Aspartame Controversy
- By James Turner, ESQ. Director of the National Institute
of Science, Law, and Public Policy (NISLAPP)
- National Institute of Science, Law, and Public Policy
1400 16th Street, NW, Suite 330, Washington, DC 20036 (202) 462-8800 Fax:
(202) 265-6564 firstname.lastname@example.org
- 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
- 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, "Yes"."
- 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
- 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 are needed.
- 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
- 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
- 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
- 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 of aspartame.
- 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.
RTM: www.dorway.com: original documents and long reviews of flaws in aspartame
toxicity research 7.31.2 rmforall
- http://www.dorway.com/upipart1.txt UPI reporter Gregory
Gordon: 96K 3-part expose Oct 1987
- "Survey of aspartame studies: correlation of outcome
and funding sources," 1998, unpublished: http://www.dorway.com/peerrev.html
Walton found 166 separate published studies in the peer reviewed medical
literature, which had relevance for questions of human safety. The 74 studies
funded by industry all (100%) attested to aspartame's safety, whereas of
the 92 non-industry funded studies, 84 (91%) identified a problem. Six
of the seven non-industry funded studies that were favorable to aspartame
safety were from the FDA, which has a public record that shows a strong
pro-industry bias. Ralph G. Walton, MD, Prof. of Clinical Psychology, Northeastern
Ohio Universities, College of Medicine, Dept. of Psychiatry, Youngstown,
OH 44501, Chairman, The Center for Behavioral Medicine, Northside Medical
Center, 500 Gypsy Lane, P.O. Box 240 Youngstown, OH 44501 330-740-3621