Aspartame: The History of A Killer -
The Whole Story.By Arthur M. Evangelista
Former FDA Investigator
1964: The development of new pharmaceuticals was the focus of research
at the international pharmaceutical company, G.D. Searle and Company (Farber
1989, page 29). A group working on an ulcer drug was formed including
Dr. Robert Mazer, James Schlatter, Arthur Goldkemp and Imperial Chemical.
In particular, they were looking for an inhibitor of the gastrointestinal
secretory hormone gastrin (Stegink 1984a).
1965: While creating a bioassay, an intermediate chemical was synthesized
-- aspartylphenylalanine-methyl-ester (aspartame). In December of 1965,
while James Schlatter was recrystalling aspartame from ethanol, the mixture
spilled onto the outside of the flask. Some of the powder got onto his
fingers. Later, when he licked his fingers to pick up a piece of paper,
he noticed a very strong sweet taste. He realized that the sweet taste
might have been the aspartame. So, believing that the dipeptide aspartame
was not likely to be toxic, he tasted a little bit and discovered its
sweet taste (Stegink 1984a, page 4). The discovery was reported in 1966,
but there was no mention of the sweetness (Furia 1972).
1969: The investigators first reported the discovery of the artificial
sweetener in the Journal of the American Chemical Society stating (Mazur
"We wish to report another accidental discovery of an organic compound
with a profound sucrose (table sugar) like taste . . . Preliminary tasting
showed this compound to have a potency of 100-200 times sucrose depending
on concentration and on what other flavors are present and to be devoid
of unpleasant aftertaste."
Today, hundreds of millions of Americans, and millions more world-wide,
consume foods and soft drinks stamped with the NutraSweet "swirl",
dump packets of Equal in their coffee, and consume NutraSweet-flavored
cereal, puddings, gelatins, cheesecake, chewing gum, diet soft drinks,
children's vitamins, chilled juices, and 9,000 other products.
So, what is aspartame, a.k.a. NutraSweet, Spoonful, Equal...etc.? aspartyl
Aspartame (C14H18N2O5 ) is a compound of three components. These components
are methanol, aspartic acid and phenylalanine (the latter being free form
Methanol (methyl alcohol or wood alcohol) is a colorless, poisonous, and
flammable liquid. It is used for making formaldehyde, acetic acid, methyl
t-butyl ether (a gasoline additive), paint strippers, carburetor cleaners
for your car's engine, and chloromethanes, et al. This poison can be inhaled
from vapors, absorbed through the skin, and ingested.
Methanol is the type of alcohol you read about when people become blind
from drinking it. In aspartame, methanol poisoning and poisoning from
methanol's breakdown components (formaldehyde and formic acid) can have
widespread and devastating effects. This occurs in even small amounts,
and is especially damaging when introduced with toxic, free-form amino
acids, called excitotoxins.
Methanol is quickly absorbed through the stomach and small intestine mucosa.
The methanol is converted into formaldehyde (a known carcinogen). Then,
via aldehyde hydrogenase, the formaldehyde is converted to formic acid.
These two metabolites of methanol are toxic and cumulative.
Phenylalanine is an amino acid. Well, amino acids are good for us, right?
Don't they keep us healthy? The answer is yes, amino acids are necessary
for good health, EXCEPT when you separate the individual amino acid from
its protein chain, and use it as an "isolate" or by itself.
The Aspartic acid, in aspartame, is also an excitotoxin. An excitotoxin,
is a deleterious substance that excites or over-stimulates nerve cells.
This occurs in the brain, as well as the peripheral nerves, because aspartic
acid, in free form, is an absorption accelerant & easily crosses the
This pathological excitation of nerve cells creates a breakdown of nerve
function, as we will see. Basically, they are a group of compounds that
can cause special neurons within the nervous system to become overexcited
to the point that these cells will die.
That's right, they are excited to death. Excitotoxins include such things
as monosodium glutamate (MSG), aspartate, (a main ingredient in NutraSweet),
L-cysteine (found in hydrolyzed vegetable protein) and related compounds.
What makes this all the more intriguing is that "excitotoxins"
appear to play a key role in degenerative nervous system diseases such
as Parkinson's disease, Alzheimer's disease, Huntington's, ALS (Lou Gehrig's
disease) and many others.
But the story doesn't stop there. It appears that an imbalance of these
excitotoxins during critical periods of brain development can result in
an abnormal formation of brain pathways; that is, a "miswiring of
the brain." This may lead to serious disorders such as behavioral
problems (hyperactivity, aggression, attention deficit disorders, learning
disorders, poor learning ability, and ADD)-and a lifetime of endocrine
problems such as menstrual difficulties, infertility, and premature puberty.
One of the earliest observations seen in animals exposed to large doses
was gross obesity. Some neuroscienttists have voiced concern that America's
explosion of childhood obesity may be related to excitotoxins in food.
Aspartame creates altered brain function, nerve damage, and systemic organ
complications. Information collected reveals that aspartame clinically
exacerbates any borderline (even yet undetected) predisposing illness,
and absolutely complicates certain known medical illnesses like Lupus,
Multiple Sclerosis, Parkinson's, diabetes, retinopathies, allergies, mentation
disorders, etc. (See list of symptoms 1)
Aspartame is a toxin, and is unique in this hazardous respect. This in
NOT an allergic reaction, but rather a true toxin. No other food can be
provided as a comparison to the toxic nature of NutraSweet. Upon closer
examination, the available research revealed that the manufacturer (Monsanto)
and the FDA are manipulating the public (via the media) into thinking
that aspartame is safe. It is not. As an American who trusted the system
we all created, as an American who worked for the system, it made me angry
that public health has taken a backseat to greed. This is the "engine"
that perpetuated this epidemic: the collusion of our government with multi-national
G.D. Searle approached Dr. Harry Waisman, Biochemist, Professor of Pediatrics,
Director of the University of Wisconsin's Joseph P. Kennedy Jr. Memorial
Laboratory of Mental Retardation Research and a respected expert in phenylalanine
toxicity, to conduct a study of the effects of aspartame on primates.
The study was initiated on January 15, 1970 and was terminated on or about
April 25, 1971. Dr. Waisman died unexpectedly in March, 1971.
Seven infant monkeys were given aspartame with milk. One died after 300
days. Five others (out of seven total) had grad mal seizures. The actual
results were hidden from the FDA when G.D. Searle submitted its initial
G.D. Searle denied knowledge of or involvement with the initiation, design
or performance of the study. Yet, false results were submitted to the
FDA like the rest of the 150 G.D. Searle studies (on aspartame and other
products), bearing a Searle Pathology-Toxicology project number. Both
Dr. Waisman and G.D. Searle were responsible for the study design. A number
of false statements were made by G.D. Searle including that the animals
were unavailable for purchase for autopsy after the termination of the
The FDA banned the sweetener cyclamate, 1969. Robert Scheuplein, who was
the acting Director of FDA's Toxicological Services Center for Food Safety
and Applied Nutrition was quoted as saying "the decision was more
a matter of politics than science."
Neuroscientist and researcher John W. Olney found that oral intake of
glutamate, aspartate and cysteine, all excitotoxic amino acids, cause
brain damage in mice (Olney 1970). Dr. John W. Olney informed G.D. Searle
that aspartic acid caused holes in the brains of mice.
Ann Reynolds, a researcher who was hired by G.D. Searle and who has done
research for the Glutamate (MSG) Association, and was asked to confirm
Dr. Olney's tests. Dr. Reynolds confirmed aspartame's neurotoxicity in
Excitotoxic compounds like MSG, aspartate, cysteine seem to create hypothalamic
lesions, particularly in young animals. The reason for the latter is likely
the fact that the blood brain barrier closes most slowly (if ever completely)
around structures like hypothalamus. The outcome for such animals (rats)
was obesity,severe behavioral changes, etc.
G.D. Searle did not inform the FDA of this study until after aspartame's
approval. None of the tests submitted by G.D. Searle to the FDA contradicted
these findings (Olney 1970, Gordon 1987, page 493 of US Senate 1987).
An internal G.D. Searle memo laid out the strategy for getting aspartame
approved (Helling 1970):
At this meeting [with FDA officials], the basic philosophy of our approach
to food and drugs should be to try to get them to say, "Yes,"
to rank the things that we are going to ask for so we are putting first
those questions we would like to get a "yes" to, even if we
have to throw some in that have no significance to us, other than putting
them in a yes saying habit.
We must create affirmative atmosphere in our dealing with them. It would
help if we can get them or get their people involved to do us any such
favors. This would also help bring them into subconscious spirit of participation.
(Refer to Actual Letter...2)
FDA Toxicologist Dr. Adrian Gross came upon some irregularities in the
submitted tests of the G.D. Searle drug Flagyl. G.D. Searle did not respond
for another two years. Their response raised serious questions about the
validity of their tests (Gross 1975, page 35)
On March 5, 1973, G.D. Searle's petition to the FDA for approval to market
aspartame as a sweetening agent was published in the Federal Register
On March 21, 1973 the MBR report was submitted to G.D. Searle. Background:
In August of 1970, G.D. Searle conducted two 78- week toxicity studies
on rats for what was to become a best-selling heart medication, Aldactone.
One study was conducted at G.D. Searle and one at Hazelton Laboratories.
In March 1972, the rats for autopsied and the pathology slides were analyzed.
For confirmation of the results, G.D. Searle sent the slides to Biological
Research, Ltd. where board certified pathologist, Dr. Jacqueline Mauro
examined the data. She discovered that the drug appeared to induce tumors
in the liver, testes, and thyroid of the rats. The report submitted to
G.D. Searle by Dr. Mauro was known as the MBR Report.
These statistically significant findings were confirmed by G.D. Searle's
Mathematics- Statistics Department.
Instead of submitting these alarming findings to the FDA, G.D. Searle
contracted with another pathologist, Dr. Donald A. Willigan.
He was given 1,000 slides to examine. The Willigan Report was more to
G.D. Searle's liking because it revealed a statistically significant increase
in thyroid and testes tumors, but not in liver tumors. Liver tumors are
of much more concern to the FDA. The Willigan Report was immediately submitted
to the FDA. G.D. Searle did not disclose the MBR Report to the FDA until
August 18, 1975, 27 months after it had been given to G.D. Searle.
At first, G.D. Searle claimed that they did not submit the MBR Report
to the FDA because of an "oversight."
The FDA Commissioner from 1972 to 1976, Alexander Schmidt, M.D. felt that
"Superficially, it seemed like, if there would ever be a safe kind
of product, that would be it. The idea that two naturally-occurring amino
acids could harm someone in relatively small amounts...."
In an FDA memorandum dated September 12, 1973, Martha M. Freeman, M.D.
of the FDA Division of Metabolic and Endocrine Drug Products addressed
the adequacy of the information submitted by G.D. Searle in their petition
to approve aspartame (Freeman 1973):
"Although it was stated that studies were also performed with diketopiperazine
[DKP] an impurity which results from acid hydrolysis of Aspartame, no
data are provided on this product."
Commenting on one particular single dose study:
"It is not feasible to extrapolate results of such single dose testing
to the likely condition of use of Aspartame as an artificial sweetener."
It is important to note that Dr. Freeman pointed out the inadequacy of
single-dose tests of aspartame as early as 1973.
Matalon said, "Let us say cigarettes were invented today, and you
give 20 people two packs a day and after six weeks, no one has cancer,
would you safe that it was safe? That's what they did with NutraSweet."
Since then, the NutraSweet Company has flooded the scientific community
with single-dose studies.
"Chemistry - No information is provided other than formulae for Aspartame
and its diketo-piperazine."
Pharmacology - Reference is made to 2 year rat studies, but no data are
provided on acute or chronic toxicity."
"Clinical - No protocols or curriculum vitae information are provided
for the 10 completed clinical studies. Results are reported in narrative
summary form, and tabulations of mean average values only.
No information is given as to the identity of the reporting labs, methodology
(except rarely), or normal values. (Reported units for several parameters
cannot be verified at this time.)
"No pharmacokinetic data are provided on absorption, excretion, metabolism,
half-life; nor bioavailability of capsule vs. food-additive administration."
Dr. Freeman concludes:
"1. The administration of Aspartame, as reported in these studies
at high dosage levels for prolonged periods, constitutes clinical investigational
use of a new drug substance."
"2. The information submitted for our review is inadequate to permit
a scientific evaluation of clinical safety."
She went on to recommend that marketing of aspartame be contingent upon
proven clinical safety of aspartame. The FDA Bureau of Foods rejected
Dr. Freeman's recommendation.
(Congressional Record 1985a)
Construction of a large aspartame manufacturing plant in Augusta, Georgia
was halted. It was thought that aspartame's uncertain regulatory future
was the main reason for the stopping of construction (Farber 1989, page
47). In the 1973 G.D. Searle Annual Report, an executive stated that "commercial
quantities of the sweetener will be supplied from the enlarged facility
Ajinomoto is the inventor and main producer of the food additive MSG.
Ninety of the 113 aspartame studies which were submitted by G.D. Searle
to the FDA were conducted in the early to mid- 1970's. All of the tests
that were described by the FDA as "pivotal" were conducted during
this time. Eighty percent of these tests were conducted by G.D. Searle
or by their major contractor, Hazleton Laboratories, Inc.
(Graves 1984, page S5497 of Congressional Record 1985a).
Dr. J. Richard Crout, the acting director of the FDA Bureau of Drugs stated
that "The information submitted for our review was limited to narrative
clinical summaries and tabulated mean values of laboratory studies. No
protocols, manufacturing controls information or preclinical data were
Such deficiencies in each area of required information precluded a scientific
evaluation of the clinical safety of this product...."
Dr. John Olney and Consumer Interest attorney, James Turner, Esq. met
with G.D. Searle to discuss the results of Olney's experiments. G.D. Searle
representative's claim that Olney's data raises no health concerns.
On July 26, 1974, just 15 months after Searle petitioned for approval,
FDA commissioner Alexander Schmidt approved aspartame use in dry foods,
allowing a 30-day period for public hearings and comment. He acted on
a strong endorsement from the Bureau of Foods, now called the Center for
Food Safety and Applied Nutrition (CFSAN).
It was not approved for baking goods, cooking, or carbonated beverages.
This approval came despite the fact that FDA scientists found serious
deficiencies in all of the 13 tests related to genetic damage which were
submitted by G.D. Searle.
At that point, consumer attorney Turner, author of a 1970 book about food
additives, objected to the short comment period.
Turner was joined in his protest by a now-defunct public interest group
and by Dr. John Olney, a Washington University neuropathologist who had
linked aspartame to brain lesions in mice.
Schmidt promptly froze the approval. In an action that was the first of
its kind, he ordered that a Public Board of Inquiry be named to look into
aspartame. Schmidt also had been alerted to conflicts between Searle research
reports and conclusions from independent animal studies that the firm's
anti-infective drug, Flagyl and its cardiovascular drug Aldactone may
cause cancer. He named a Bureau of Drugs task force to investigate.
Philip Brodsky, the unit's since-retired lead investigator, said aspartame
was included in a broad inquiry into Searle animal studies on five drugs
and the Copper-7 intrauterine device to surprise the company. "We
didn't think they'd expect us to cover it."
The task force assailed Searle's conduct of research on most of the products,
including aspartame, in a searing, 84-page report.
"At the heart of the FDA's regulatory process," the report said,
"is its ability to rely upon the integrity of the basic safety data
submitted by sponsors of regulated products. Our investigation clearly
demonstrates that, in the G.D. Searle Co., we have no basis for such reliance
The task force charged, for example, that the company removed tumors from
live animals and stored animal tissues in formaldehyde for so long that
they deteriorated. Instead of performing autopsies on rhesus monkeys that
suffered seizures after being fed aspartame, the company had financed
a new monkey study with a different methodology that showed no problems.
For the next seven years, Searle's petition was tied up in reviews by
the task force and other sharply critical FDA panels.
At the task force's request, Richard Merrill, the FDA's general counsel,
demanded in a letter that Samuel Skinner, the U.S. attorney in Chicago,
open a grand jury investigation of Searle and three of its employees.
One Searle official named by Merrill was Robert McConnell, who had been
director of Searle's Department of Pathology and Toxicology and oversaw
most of the company's aspartame research.
McConnell's Detroit lawyer, Gerald Wahl, said that as the inquiries heated
up, his client was suddenly awarded a $15,000 bonus and asked to take
a three-year sabbatical by director Wesley Dixon. Wahl said Dixon told
McConnell he had become a "political liability," a remark Dixon
later denied making.
McConnell received his annual salary of more than $60,000 during the sabbatical
at the Massachusetts Institute of Technology, but he never got his job
back, and ended up suing the company, Wahl said.
"I've represented hundreds of executives, but I've never seen anybody
get the deal that McConnell got," he said. "When you boil it
all down, they were looking for continued support from McConnell during
G.D. Searle's responses to queries about the testing of their drug Flagyl,
serious and unexpected side effect from other drugs they developed, and
information from Dr. John Olney's studies started a controversy within
the FDA as to the quality and validity of G.D. Searle's test of aspartame
and pharmaceuticals (Congressional Record 1985a).
In July 1975, the FDA Commissioner, Dr. Alexander Schmidt appointed a
special Task Force to look at 25 key studies for the drugs Flagyl, Aldactone,
Norpace, and the food additive aspartame. Eleven of the pivotal studies
examined involved aspartame. All of the studies whether conducted at G.D.
Searle or Hazleton Laboratories were the responsibility of the Pathology-Toxicology
Department at G.D. Searle. (Gross 1987a, page 430 of US Senate 1987).
The special Task Force was headed by Philip Brodsky, FDA's Lead Investigator
and assisted by FDA Toxicologist, Dr. Adrian Gross. The Task Force was
especially interested in "pivotal" tests as described in an
article from Common Cause Magazine by Florence Graves (Graves 1984, page
S5499 of Congressional Record 1985a):
"Before the task force had completed its investigation in 1976, Searle
had submitted the vast majority of the more than 100 tests it ultimately
gave the FDA in an effort to get aspartame approved.
These included all test ever described as 'pivotal' by the FDA. About
half the pivotal tests were done at Searle; about one-third were done
at Hazleton Laboratories. 'Pivotal' tests include long-term (two-year)
tests such as those done to determine whether aspartame might cause cancer.
Former FDA commissioner Alexander Schmidt said in a recent interview that
if a pivotal test is found to be unreliable, it must be repeated 'Some
studies are more important than others, and they have to be done impeccably,'
G.D. Searle executives admitted to "payments to employees of certain
foreign governments to obtain sales of their products." (Searle 1975)
Consumer lawyer Turner said, "The notion that an industrial company
would take large sums of money and parcel it out to scientific consulting
firms and university departments, who they consider to be personal and
commercial allies is an unconscionable way to ensure the safety of the
American food supply."
He said the NutraSweet experience shows that "the entire system of
the way scientific research is done needs to be carefully investigated,
evaluated, and revamped."
Food industry officials also said most studies financed by Searle or the
NutraSweet Co. have been arranged as contracts, rather than grants. Smith
said the company often uses contracts "to accomplish a specific research
James Scala, former director of health sciences for the General Foods
Corp., a major NutraSweet user, said that a scientist working under contract
became "more of an arm of the Searle research group than a grantee."
On July 10, 1975, Senator Edward Kennedy chaired a hearing on drug-related
research before the Senate Subcommittee on Health of the Committee on
Labor and Public Welfare (US Senate 1975). Preliminary reports of discrepancies
discovered about G.D. Searle were discussed.
The findings of the FDA Task Force were later presented at further hearings
on January 20, 1976 (US Senate 1976a) and April 8, 1976 (US Senate 1976b).
Chief investigator Brodsky said that "politicized" handling
of the task force disclosures, at hearings chaired by Sen. Edward Kennedy
D-Mass., was one reason he retired in 1977. He said the main witnesses,
Searle executives, and top FDA officials uninvolved in the investigation
gave "the wrong answers to the wrong questions"...They didn't
even let the experts answer the questions.
On December 5, 1975, Dr. John Olney and James Turner waived their right
to a hearing at the suggestion of the FDA General Counsel after the FDA
and G.D. Searle agreed to hold a Public Board Of Inquiry (PBOI) (Federal
On December 5, 1975, the FDA put a hold on the approval of aspartame due
to the preliminary findings of the FDA Task Force. The Public Board of
Inquiry is also put on hold.
The evidence of the aspartame pivotal studies were protected under FDA
seal on December 3, 1975 (Sharp 1975).
G.D. Searle had invested 19.7 million dollars in an incomplete production
facility and 9.2. million dollars in aspartame inventory. On December
8, 1975, stockholders filed a class action lawsuit alleging that G.D.
Searle had concealed information from the public regarding the nature
and quality of animal research at G.D. Searle in violation of the Securities
and Exchange Act (Farber 1989, page 48).
On January 7, 1976, G.D. Searle submitted to the FDA their proposal for
the adoption of "Good Laboratory Practices" (Buzzard 1976b).
G.D. Searle's input was used in FDA's adoption of Good Laboratory Practices.
In March 1976, the FDA Task Force completed a 500-page report with 15,000
pages of exhibits (80-page summary) to the FDA after completing their
investigation (Schmidt 1976c, page 4 of US Senate 1976b).
A preliminary statement about the breadth of the investigation from FDA
Toxicologist and Task Force team member, Dr. Andrian Gross before the
US Senate (Gross 1987a, page 1-2):
"Practices that were noted in connection with any given such study
were quite likely to have been noted also for other studies that were
audited, and this was a situation which was in no way unexpected: after
all, the set of all such studies executed by that firm from about 1968
to the mid- 1970's were conducted in essentially the same facilities,
by virtually the same technicians, professional workers and supervisors,
and the nature of such studies does not differ much whether a food additive
or a drug product is being tested for safety in laboratory animals.
It is in this sense, therefore, that the overall conclusion summarized
at the beginning of the Searle Task Force Report have relevance to all
the studies audited in 1975 (whether they had references to aspartame
or to any of the six drug products of Searle's) and, by extension, to
the totality of experimental studies carried out by that firm around that
time -- 1968 to 1975."
A few of the conclusions of the FDA Task Force (Gross 1987a, page 2-3):
"At the heart of FDA's regulatory process is its ability to rely
upon the integrity of the basic safety data submitted by sponsors of regulated
products. Our investigation clearly demonstrates that, in the (case of
the) GD Searle Company, we have no basis for such reliance now."
"We have noted that Searle has not submitted all the facts of experiments
to FDA, retaining unto itself the unpermitted option of filtering, interpreting,
and not submitting information which we would consider material to the
safety evaluation of the product .. . . Finally, we have found instances
of irrelevant or unproductive animal research where experiments have been
poorly conceived, carelessly executed, or inaccurately analyzed or reported."
"Some of our findings suggest an attitude of disregard for FDA's
mission of protection of the public health by selectively reporting the
results of studies in a manner which allay the concerns of questions of
an FDA reviewer."
"Unreliability in Searle's animal research does not imply, however,
that its animal studies have provided no useful information on the safety
of its products. Poorly controlled experiments containing random errors
blur the differences between treated and control animals and increase
the difficulty of discriminating between the two populations to detect
a product induced effect.
A positive finding of toxicity in the test animals in a poorly controlled
study provides a reasonable lower bound on the true toxicity of the substance.
The agency must be free to conclude that the results from such a study,
while admittedly imprecise as to incidence or severity of the untoward
effect, cannot be overlooked in arriving at a decision concerning the
toxic potential of the product."
A few of the relevant findings summarized from various documents describing
the FDA Task Force Report:
* "Excising masses (tumors) from live animals, in some cases without
histologic examination of the masses, in others without reporting them
to the FDA." (Schmidt 1976c, page 4 of US Senate 1976b) Searle's
representatives, when caught and questioned about these actions, stated
that "these masses were in the head and neck areas and prevented
the animals from feeding." (Buzzard 1976a)
"Failure to report to the FDA all internal tumors present in the
experimental rats, e.g., polyps in the uterus, ovary neoplasms as well
as other lesions." (Gross 1987a, page 8).
* G.D. Searle "stored animal tissues in formaldehyde for so long
that they deteriorated." (Gordon 1987, page 496 of US Senate 1987;
US Schmidt 1976c, page 25, 27 of US Senate 1976b)
* "Instead of performing autopsies on rhesus monkeys that suffered
seizures after being fed aspartame, the company had financed a new monkey
seizure study with a different methodology that showed no problems."
(Gordon 1987, page 496 of US Senate 1987)
* "Reporting animals as unavailable for necropsy when, in fact, records
indicate that the animals were available but Searle choose not to purchase
them." (Schmidt 1976c, page 5 of US Senate 1976b)
* Animals which had died were sometimes recorded as being alive and vice
versa. "These include approximately 20 instances of animals reported
as dead and then reported as having vital signs normal again at subsequent
observation periods." (Gross 1985, page S10835)
* "Selecting statistical procedures which used a total number of
animals as the denominator when only a portion of the animals were examined,
thus reducing the significance of adverse effects." (Schmidt 1976c,
page 4 of US Senate 1976b)
* G.D. Searle told the FDA that 12 lots of DKP were manufactured and tested
in one study, yet only seven batches were actually made. (Gross 1985,
* "Significant deviations from the protocols of several studies were
noted which may have compromised the value of these studies . . . In at
least one study, the Aspartame 52 weeks monkey study, the protocol was
written after the study had been initiated." (Gross 1985, page S10835)
* "It is significant to note that the Searle employee responsible
for reviewing most of the reproduction studies had only one year of prior
experience, working on population dynamics of cotton tail rabbits while
employed by Illinois Wildlife Service. In order to prepare him for this
title of 'Senior Research Assistant in Teratology' (fetal damage) Searle
bought him books to read on the subject and also sent him to a meeting
of the Teratology Society. This qualified him to submit 18 of the initial
tests to the FDA, in addition to training an assistant and 2 technicians.
He certainly must have kept them busy because Searle claimed that 329
teratology examinations were conducted in just 2 days. He estimated that
he himself examined about 30 fetuses a day, but officials for the Center
for Food and Applied Nutrition could never determine how that was possible."
* "In each study investigated, poor practices, inaccuracies, and
discrepancies were noted in the antemortem phases which could compromise
* "Presenting information to FDA in a manner likely to obscure problems,
such as editing the report of a consulting pathologist . . . Reporting
one pathology report while failing to submit, or make reference to another
usually more adverse pathology report on the same slide." (Schmidt
1976c, page 4-5 of US Senate 1976b)
* Animals were not removed from the room during the twice per month exterminator
sprayings. (Gross 1985, page S10836 of Congressional Record 1985b)
* Often the substance being tested which was given to the animals was
not analyzed or tested for homogeneity. "No records were found
to indicate that any treatment mixtures used in the studies were ever
tested or assayed for pesticide content . . . Running inventory records
for either treatment mixtures or the test compounds used in treatment
mixtures are not maintained."
* In the Aspartame (DKP) 115 week rat study the written observations of
the pathology report was changed by the supervising pathologist, Dr. Rudolph
Stejskal even though he was not physically present during the autopsies
and could not have verified the observations of the pathologist who did
perform the autopsies. The pathologist who did perform some of the autopsies
had no formal training for such procedures.
* "Contrary to protocol, slides were not prepared of this [unusual
lesions from the Aspartame (DKP) study) tissue for microscopic examinations
. . . .."
* "In the Aspartame 46 weeks hamster study, blood samples reported
in the submission to FDA as 26 week values (for certain specified animals)
were found by our investigators as being, in fact, values for different
animals which were bled at the 38th week. Many of the animals for which
these values were reported (to the FDA) were dead at the 38th week."
(Gross 1985, page S10838)
"It is apparent from the report, that the Appendix portion contains
all the individual (animal) values of clinical lab data available from
the raw data file. A selected portion of these values appears to have
been used in computing group means (which were reported to the FDA). It
is not clear what criteria may have been used for selecting a portion
of the data or for deleting the others in computing the means (reported
to the FDA)." (Gross 1985, page S10838 of Congressional Record 1985b)
* "Searle technical personnel failed to adhere to protocols, make
accurate observations, sign and date records, and accurately administer
the product under test and proper lab procedures."
* [There were] "clerical or arithmetic errors which resulted in reports
of fewer tumors."
* [G.D. Searle] "delayed the reporting of alarming findings."
FDA Toxicologist and Task Force member, Dr. Andrian Gross stated:
"They [G.D. Searle] lied and they didn't submit the real nature of
their observations because had they done that it is more than likely that
a great number of these studies would have been rejected simply for adequacy.
What Searle did, they took great pains to camouflage these shortcomings
of the study.
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 they would remove these
tumors from the animals."
FDA Lead Investigator and Task Force Team Leader, Phillip Brodsky described
the 1975 FDA Task Force members as some of the most experienced drug investigators.
He went on to state that he had never seen anything as bad as G.D. Searle's
The report quoted a letter written to G.D. Searle on July 15, 1975 from
its consultant in reproduction and teratology, Dr. Gregory Palmer, in
regards to a review of some of G.D. Searle's reproductive studies submitted
to the FDA; (as noted in the Congressional record)
"Even following the track you did, it seems to me you have only confounded
the issue by a series of studies most of which have severe design deficiencies
or obvious lack of expertise in animal management. Because of these twin
factors, all the careful and detailed examination of fetuses, all the
writing, summarization and resummarization is of little avail because
of the shaky foundation."
G.D. Searle officials noted that Dr. Palmer did not look at all of the
teratology studies (Searle 1976b, page 21). However, there is no credible
evidence that would lead a reasonable person to believe that the studies
which were not presented to Dr. Palmer were much better. In fact, the
evidence shows that it is very likely that all of the studies were abysmal.
The FDA Commissioner at the time, Alexander Schmidt stated (Graves 1984,
page S5497 of Congressional Record 1985a):
"[Searle's studies were] incredibly sloppy science. What we discovered
Dr. Marvin Legator, professor and director of environmental toxicology
at the University of Texas and the pioneer of mutagenicity testing at
the FDA from 1962 to 1972 was asked by Common Cause Magazine to review
the FDA investigation results of G.D. Searle's tests page (Congressional
"[All tests were] scientifically irresponsible [and] disgraceful.
I'm just shocked that that kind of sloppy [work] would even be sent to
FDA, and that the FDA administrators accepted it. There is no reason why
these tests couldn't have been carried out correctly. It's not that we
are talking about some great scientific breakthrough in methodology."
Senator Edward Kennedy at the April 8, 1976 hearings before the Senate
Subcommittee on Labor and Public Welfare stated (Se. Ted Kennedy 1976):
"The extensive nature of the almost unbelievable range of abuses
discovered by the FDA on several major Searle products is profoundly disturbing."
"In all of the studies at Searle which have been examined by the
FDA in its investigation, the scope of the material being considered included
seven years of observation, from 1968 to date, in 57 studies involving
more than 5,700 animals with over 228 million observations and calculations."
However, their deliberate misconduct and "lies" (as put by FDA
Investigator, Dr. Adrian Gross) invalidated their experiments for the
* Many of the problems with the studies included horrendous experimental
designs, questions regarding dosage given, loss of animal tissue and data,
etc., etc., which invalidates entire experiments and causes what they
claim to be 4 million observations and calculations per study (average)
to become irrelevant.
* Only the key aspartame studies were looked at. It is almost a certainty
that the non-key aspartame studies were equally flawed. Therefore, this
would invalidate the "hundreds of millions" of observations
and calculations made during these studies.
* The difference between a study showing no statistical difference and
a significant statistical difference is often only a few observations
or calculations. Therefore, had the myriad of other serious experimental
errors not occurred (as detailed above), the observation and calculation
mistakes in each experiment investigated would, by themselves, invalidate
most of the key studies.
* It is highly unlikely that the FDA Investigative teams found all of
the problems with G.D. Searle's studies. G.D. Searle seemed so intent
on covering up their misconduct, that it is quite likely that they were
able to hide many of the problems from the FDA.
A series of poorly conceived, flawed studies funded by G.D. Searle were
published in Volume 2 (1976) of the Journal of Toxicology and Environmental
Health. An Associate Editor of this scientific journal was Robert G. McConnell,
the Director of G.D. Searle's Department of Pathology and Toxicology (the
department responsible for monitoring the quality of G.D. Searle's pre-approval
tests investigated by the 1975 FDA Task Force). Mr. McConnell's story
continues later in 1977.
Another G.D. Searle employee, Carl R. Mackerer was an editor of the journal.
Another editor of the journal was Thomas R. Tephly, the person responsible
for conducting a series of badly flawed blood methanol and formate measurements
in NutraSweet-funded studies over the last 15 years.
In July 1976, the FDA decided to investigate 15 key aspartame studies
submitted by G.D. Searle in which the 1975 FDA Task Force discovered problems.
Three (3) of the studies were investigated at the FDA (E5, E77/78, E89)
by a 5-member Task Force headed by FDA veteran Inspector, Jerome Bressler.
On August 4, 1976, G.D. Searle representatives met with the FDA and convinced
them to allow G.D. Searle to hire a private agency, University Associated
for Education in Pathology (UAREP), and pay them $500,000 to "validate"
the other 12 studies.
According the FDA Commissioner during the early 1980s, Arthur Hull Hayes,
the UAREP investigation was to "make sure that the studies were actually
As described by Florence Graves:
"The pathologists were specifically told that they were not to make
a judgment about aspartame's safety or to look at the designs of the tests.
Why did the FDA choose to have pathologists conduct an investigation when
even some FDA officials acknowledged at the time that UAREP had a limited
task which would only partially shed light on the validity of Searle's
testing? The answer is not clear.
"Dr. Kenneth Endicott, Director of UAREP, said in an interview that
the FDA had 'reasons to suspect' that Searle's tests 'were not entirely
honest.' Because the FDA 'had doubts about [Searle's] veracity,' Edicott
said, officials wanted UAREP 'to determine whether the reports were accurate.'
"FDA scientist Dr. Adrian Gross, in a letter to an FDA official,
said, 'speaking as a pathologist, it seemed questionable that the group
could do the kind of comprehensive investigation that was required. He
pointed in particular to a variety of issues that needed to be investigated.
He said some of these would involved closely questioning administrators
and lab technicians about their practices. Since many important issues
that should be investigated 'have nothing to do with pathology,' he said,
only trained FDA investigators were qualified to do a comprehensive evaluation
of the testing. . . .
(SEE LETTER BY DR. ADRIAN GROSS 3)
"Meanwhile, an interview with Endicott indicates that Adrian Gross
was right: the pathologists couldn't--and didn't--carry out a comprehensive
review. . . . As former FDA Commissioner Alexander Schmidt put it in a
recent interview, UAREP looked at the slides to determine whether they
had been misrepresented, but didn't look at the conduct of the experiments
in depth. The 1975 [FDA] task force investigation looked at the conduct
of the experiments in depth, but did not look at the slides. .. . . Endicott
agreed . . . 'We could only look at what was there--the tissues.'
The findings of this investigation where released in the Bessler Report
in August 1977 (see below).
1977 OUR POLITICAL PROCESS AT WORK:
Donald Rumsfeld, who was a former member of the U.S. Congress and the
Chief of Staff in the Gerald Ford Administration, was hired as G.D. Searle's
President. Attorney James Turner, Esq. alleged that G.D. Searle hired
Rumsfeld to handle the aspartame approval difficulties as a "legal
problem rather than a scientific problem." (US Senate 1987).
Rumsfeld hired: John Robson as Executive Vice President. He was a former
lawyer with Sidley and Austin, Searle's Law Firm and also served as chairman
of the Civil Aeronautics Board, which was then connect to the Department
Robert Shapiro as General Counsel. He is now head of Searle's NutraSweet
Division. He had been Robson's Special Assistant at the Department of
William Greener, Jr., as Chief Spokesman. He was a former spokesman in
the [Gerald] Ford White House.
Donald Rumsfeld is now on the Board of Directors of the Chicago Tribune
which recently wrote a glowing article about the NutraSweet Company.
On January 10, 1977, FDA Chief Counsel Richard Merrill recommended to
U.S. Attorney Sam Skinner in a 33-page letter detailing violations of
the law that a grand jury be set up to investigate G.D. Searle. In the
letter, Merrill stated:
"We request that your office convene a Grand Jury investigation into
apparent violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S..C.
331(e), and the False Reports to the Government Act, 18 U.S.C. 1001, by
G.D. Searle and Company and three of its responsible officers for their
willful and knowing failure to make reports to the Food and Drug Administration
required by the Act, 21 U.S.C. 355(i), and for concealing material facts
and making false statements in reports of animal studies conducted to
establish the safety of the drug Aldactone and the food additive Aspartame."
All of the G.D. Searle studies were abysmal as discussed earlier. However,
there were two studies where the violations of the law appeared to be
especially flagrant. The two studies cited by Merrill were the 52-week
toxicity study on infant monkeys performed by Dr. Waisman which G.D. Searle
withheld key information from the FDA and the 46-week toxicity study of
hamsters where G.D. Searle had taken blood from healthy animals at the
26th week and claimed that the tests had actually been performed at the
Many of the animals from which G.D. Searle claimed had blood drawn from
were actually dead at the 38th week. See earlier discussion for references.
On January 26, 1977, G.D. Searle's law firm, Sidley & Austin, requested
a meeting with U.S. Attorney Samuel Skinner before a grand jury is convened.
One representative of Sidley & Austin at that meeting was Newton Minow
who is currently on the Board of Directors at the Chicago Tribune.
On March 8, 1977, in a confidential memo to aides, while he was supposed
to be pushing for fraud indictments against G.D. Searle, U.S. Attorney
Samuel Skinner stated that he had begun preliminary employment discussions
with G.D. Searle's law firm Sidley & Austin. page 497 of US Senate
On April 13, 1977, a U.S. Justice Department memo urged U.S. Attorney
Samuel Skinner to proceed with grand jury investigations of G.D. Searle.
The memo points out that the Statute of limitations on prosecution would
run out shortly (October 10, 1977 for the Waisman monkey study and December
8, 1977 for the hamster study.
Samual Skinner withdrew from the G.D. Searle case and Assistant U.S. Attorney
William Conlon was then assigned to the Grand Jury investigation (Gordon
1987, page 497 of US Senate 1987).
On July 1, 1977, U.S. Attorney Samuel Skinner left his job to work for
the G.D. Searle law firm Sidley & Austin. Thomas Sullivan was appointed
as Samuel Skinner's successor page 497 of US Senate 1987).
Meanwhile, Much like the earlier team, the five-member FDA task force,
headed by veteran Chicago inspector Jerome Bressler, assailed the quality
of animal tests into whether the substance might cause birth defects and
tumors. The report said Searle laboratory employee Raymond Schroeder,
who worked on related research, first told investigators the feed in the
study of the aspartame breakdown product DKP (diketopiperazine) was so
inadequately mixed it appeared the rats could "discriminate"
and avoid eating the DKP. Schroeder, who has worked for another company
since 1975, later backed off his statement. He told UPI, "I just
didn't feel qualified to speak on something I didn't work on...There's
no one twisting my arm."
In August 1977, the Bressler Report pertaining to three key aspartame
studies, E5, E77/78 and E89, was released. Some of the findings from the
three studies reviewed by the Bressler- led FDA Task Force include.
* In one study, 98 of the 196 animals died but were not autopsied until
as much as one year later. Because of the delay, much of the animal tissue
could not be used and at least 20 animals had to be excluded from postmortem
* The original pathology sheets and the pathology sheets submitted to
the FDA showed differences for 30 animals.
* One animal was reported alive at week 88, dead from week 92 through
week 104, alive at week 108, and finally dead at week 112.
* An outbreak of an infectious disease was not reported to the FDA.
* Tissue from some animals were noted to be unavailable for analysis on
the pathology sheets, yet results from an analysis of this "unavailable"
tissue was submitted to the FDA.
* There was evidence that the diet mix was not homogeneous allowing the
animals to eat around the test substance. This evidence included a picture
and statements by a lab technician.
* Fifteen fetuses from animals in one experiment were missing.
* Sections from the animals were too thick for examination.
* There was no documentation on the age or source of the test animals.
* There was no protocol until one of the studies was well underway.
* Animals were not permanently tagged to prevent mix-ups.
* Some laboratory methods were changed during the study, but not documented.
A G.D. Searle pathologist referring to the DKP study was quoted by investigators
"You should have seen things when this study was run -- there were
five studies being run at one time -- things were a mess!"
The leader of the Task Force, Jerome Bressler, was quoted as saying:
"The question you have got to ask yourself is: Because of the importance
of this study, why wasn't greater care taken? The study is highly questionable
because of our findings. Why didn't Searle, with their scientists, closely
evaluate this, knowing fully well that the whole society, from the youngest
to the elderly, from the sick to the unsick . .. . will have access to
Howard Roberts, acting director of FDA's Bureau of Foods, appointed a
five-person task force to review the Bressler team's findings pending
a decision on whether to throw out the three tumor and birth-defect studies.
Jacqueline Verrett, a senior FDA scientist on the review team, said members
were barred from stating opinions about the research quality. "It
was pretty obvious that somewhere along that line they (bureau officials)
were working up to a whitewash," she said.
"I seriously thought of just walking off of that task force."
Verrett, now a private consultant, said that she and other members wanted
to "just come out and say that this whole experiment was a disaster
and should be disregarded."
But on September 28, 1977, the panel reported that deviations between
Searle's raw data and its FDA submissions were "not of such magnitude
as to alter its conclusion."
Verrett said the bureau's intent seemed to be "to tone down what
was really found." She noted the bureau felt pressure because safety
concerns also had been raised about cyclamate, another alternative for
the cancer-linked sugar substitute, saccharin.
In October, 1978, a year after ordering the review that helped get Searle's
petition back on track, Robert's (acting Director of Bureau of Foods)
quit to become vice president at the National Soft Drink Association.
The NSDA's members later marketed a stream of NutraSweet-flavored diet
soft drink products.
Reached at NSDA, Roberts dismissed Verrett's criticism, asserting the
task force report "really was of no importance." He said he
had no concerns about the appearance of his taking the NSDA job, stressing
he does not represent NSDA before the FDA. "I sleep well at night,"
For each of the major discrepancies found by the Bressler-led Task Force
-- those listed above and many others -- there was a comment in the FDA
Bureau of Foods Report minimizing the problem. It seemed that no matter
how serious the mistakes were, the FDA Bureau of Foods was determined
to accept the studies by G.D. Searle.
The experimental errors as described above were so bad that it proved
difficult to minimize all of the major errors in these key studies.
In some cases, the best that the CFSAN could do was to say that "The
Task Force could find no evidence that this was a deliberate attempt to
influence the study." or "It could not be determined if the
results would have been altered...."
The Senior Scientist of the FDA Bureau of Foods Task Force, Jacqueline
Verrett had left the FDA. Speaking for the UPI Investigation into Aspartame,
she said, 'I seriously thought of just walking off of that task force.'
Verrett, now a private consultant, said that she and other members wanted
to 'just come out and say that this whole experiment was a disaster and
should be disregarded.'
In her testimony before the U.S. Senate, Dr. Verrett stated the following
"This authentication was hence intended to verify that the submitted
data had not been altered; that it reflected the actual outcome of the
study, and that it did not change substantially, particularly in a statistical
sense, the various parameters from which the conclusion of safety had
"Our analysis of the data in this manner revealed that in these three
studies, there were really no substantial changes that resulted, although
in numerous instances, a definitive answer could not be arrived at because
of the basic inadequacies and improper procedures used in the execution
of these studies.
"I would like to emphasize the point that we were specifically instructed
not to be concerned with, or to comment upon, the overall validity of
the study. This was to be done in a subsequent review, carried out at
a higher level. . . . . "It would appear that the safety of aspartame
and its breakdown products has still not been satisfactorily determined,
since many of the flaws cited in these three studies were also present
in all of the other studies submitted by Searle. . . . ..
"Well, they told us in no uncertain terms that we were not to comment
on the validity of it. And I hoped, although having been there at that
point for 19 years, I should have known better, that there really would
be an objective evaluation of this beyond the evaluation that we did.
"I do not feel that that was done, based on what I have read in the
GAO report that I have looked at and so forth. They definitely did not
objectively evaluate these studies, and I really think it should have
been thrown out from day one.
"We were looking at a lot of little details and easy parameters in
this study, when the foundation of the study, the diet and all of these
other things, were worthless. We were talking about the jockey when we
should have been talking about the horse, that he had weak legs. It is
built on a foundation of sand."
The FDA general counsel wrote a letter to Consumer Attorney, James Turner,
Esq. responding to Mr. Turner's concern about the quality and validity
of G.D. Searle's experiments. The FDA stated, "The Public Board of
Inquiry on aspartame should provide a vehicle for definitive resolution,
at least for those studies about which you are most concerned.
As will be discussed later, Dr. John Olney and James Turner, Esq. were
not allowed to have the quality and validity of the G.D. Searle studies
considered at the Public Board of Inquiry.
On December 13, 1978, UAREP submitted its results of their analysis of
12 of G.D. Searle's aspartame studies. UAREP stated in their report that
"no discrepancies in any of the sponsor's reports that were of sufficient
magnitude or nature that would compromise that data originally submitted."
(Farber 1989, page 33) Remember, the Director of UAREP pointed out in
an interview that their pathologists did not conduct a comprehensive review
of the studies, they only looked at the animal tissues.
As it turns out, UAREP pathologists who examined the test results were
discovered to have missed and withheld negative findings from the FDA.
In some cases, they completely missed cancerous brain tumors when analyzing
the slides. In addition, some of the slides that were to be examined by
UAREP pathologists were missing even though they where supposed to have
been kept under "FDA seal." (Olney 1987, page 6-7)
FDA Toxicologist Adrian Gross stated that the UAREP review "may well
be interpreted as nothing short of a whitewash." (Farber 1989, page
114). Given that the UAREP review results was so biased in favor of G.D.
Searle, one wonders why the FDA would allow a company being investigated
for fraud to pay $500,000 and hire an outside entity to "validate"
Even though the UAREP report was biased, there were numerous instances
in that report which demonstrated that G.D. Searle had not submitted even
marginally accurate findings to the FDA of their pre-approval aspartame
tests. For example, in one study, twelve animals actually had cancerous
brain tumors, yet UAREP reported to the FDA that only three animals had
In March of 1979, the FDA somehow concluded that G.D. Searle's aspartame
studies could be accepted. They decide to convene the Public Board of
Inquiry (PBOI) which was agreed to by Dr. John Olney and Attorney James
Turner more than four years earlier (Federal Register 1979).
In April of 1979, the FDA outlined the specific questions which were to
be addressed by the PBOI. The FDA limited the scope of the PBOI to (Federal
* Whether the ingestion of aspartame either alone or together with glutamate
poses a risk of contributing to mental retardation, brain damage, or undesirable
effects on neuroendocrine regulatory systems.
* Whether the ingestion of aspartame may induce brain neoplasms (tumors)
in the rat.
* Based on answer to the above questions.
(i) Should aspartame be allowed for use in foods, or, instead should approval
of aspartame be withdrawn?
(ii) If aspartame is allowed for use in foods, i.e., if its approval is
not withdrawn, what conditions of use and labeling and label statements
should be required, if any?
Dr. John Olney, G.D. Searle, and the FDA's Bureau of Foods were allowed
to nominate scientists for the 3-person PBOI panel (Farber 1989, page
34, Federal Register 1981, page 38286).
It is important to note that the scope of the review was very limited
in light of all of the various adverse reactions reported to the FDA.
The PBOI also disallowed any discussion of the validity of the pre-approval
experiments because it accepted the word of certain FDA officials that
these experiments had been "validated." Finally, the PBOI was
told not to consider aspartame in beverages, only in dry goods.
In June of 1979, the acting FDA Commissioner, Sherwin Gardner selected
the 3-person Public Board of Inquiry. The panelists were Peter J. Lampert,
M.D., Professor and Chairman, Department of Pathology, University of California
(San Diego), Vernon R. Young, Ph.D., University of Nutritional Biochemistry,
M.I.T., and Walle Nauta, M.D., Ph.D., Institute Professor, Department
of Psychology and Brain Science, M.I.T.
Dr. John Olney strongly objected to the Commissioner's selection of one
of the panelists, Dr. Vernon Young, on grounds of conflict of interest
and lack of qualifications (Olney 1987, page 3). Dr. Young had written
nonaspartame- related articles in collaboration with G.D. Searle scientists
(Brannigan 1983, page 196).
In addition, Dr. Olney stated that the question of aspartic acid's neurotoxicity
should be looked at by a neuropathologist and that Dr. Young was unqualified
since his field was Nutrition and Metabolism. Dr. Olney's objections were
overruled by acting FDA Commissioner Sherwin Gardner and the panelists
who he objected to was assigned to study the issue of aspartic acid toxicity.
One of the PBOI members, Dr. Walle Nauta stated (Graves 1984, page S5498
of Congressional Record 1985a):
"It was a shocking story we were told [about Searle's animal testing]
but, there was no way we could go after it. We had absolutely no way of
knowing who was right. We had to take the FDA's word."
Dr. Nauta stated that he would have "definately" considered
other tests and factors if he had known that aspartame was planned for
use in soft drinks (Graves 1984, page S5503 of Congressional Record 1985a).
The Public Board Of Inquiry voted unanimously to reject the use of aspartame
until additional studies on aspartame's potential to cause brain tumors
could be done. The PBOI was particularly concerned about experiment E33/34
where 320 rats received aspartame and a much higher percentage of animals
in the aspartame group developed tumors than in the control group (Brannigan
1983, page 196).
In addition, the PBOI was concerned about experiment E70 where 80 rats
received aspartame. Both the aspartame group and the control group had
an unusually high number of tumors, leading one to suspect that both groups
were actually given aspartame (Federal Register 1981).
The PBOI did not believe that aspartic acid presented a neurotoxic hazard.
Yet, Dr. Olney pointed out that (Olney 1987, page 3):
"[Dr. Young had a] lack of qualification" and that he "based
his decision on a consideration of [aspartic acid] alone without regard
to the real issue, i.e., is it safe to add [aspartic acid] to the large
amounts of [glutamic acid/MSG] that are already adulterating the food
In addition, the "conservative" safety plasma level of aspartic
acid used by Dr. Young was the level at which half the animals developed
brain damage (Brannigan 1983, page 197).
These errors by Dr. Young throw the question of safety of aspartic acid
as part of aspartame into doubt. We will address this issue in more detail
in a later section.
On January 21, 1981, the day after Ronald Reagan takes office as U.S.
President, G.D. Searle reapplied for the approval of aspartame. G.D. Searle
submits several new studies along with their application. It was believed
that Reagan would certainly replace Jere Goyan, the FDA Commissioner.
G.D. Searle president, Donald Rumsfeld's connections to the Republican
party were also thought to play a part in Searle's decision to reapply
for aspartame's approval on the day after Ronald Reagan was inaugurated
(Gordon 1987, page 499 of US Senate 1987).
According to a former G.D. Searle salesperson, Patty Wood- Allott, G.D.
Searle president, Donald Rumsfeld told his sales force that, if necessary,
"he would call in all his markers and that no matter what, he would
see to it that aspartame would be approved that year." (Gordon 1987,
page 499 of US Senate 1987)
Robert Dormer, a lawyer for the NutraSweet Co., said there was nothing
special about the Jan. 21 date or the papers filed that day.
But with Reagan's election, it was virtually assured that a republican-appointed
commissioner would replace Goyan and decide the appeal- and Searle had
strong GOP connections with Rumsfeld at the helm.
Goyan had set up a five-member "commissioner's team" of scientists
with no prior involvement in the issue to review the board's ruling.
In April 1981, Arthur Hull Hayes, Jr. was appointed FDA Commissioner by
Ronald Reagan (Graves 1984, page S5502 of Congressional Record 1985a).
On May 18, 1981, three of the scientists in the 5-member panel sent a
letter to the panel lawyer, Joseph Levitt discussing their concerns about
Those three scientists were Satva Dubey (FDA Chief of Statistical Evaluation
Branch), Douglas Park (Staff Science Advisor), and Robert Condon (Veterinary
Medicine). Dubey thought that the brain tumor data was so "worrisome"
in one study that he could not recommend approval of aspartame (Gordon
1987, page 495 of US Senate 1987).
In another study, Dubey said that key data appeared to have been altered
Gordon 1987, page 499 of US Senate 1987).
In his UPI Investigation, Gregory Gordon went on to describe the unusual
events that followed (Gordon 1987, page 499 of US Senate 1987):
"[Douglas] Park said that panel lawyer Joseph Levitt hurried the
panel to decide the issue. 'They wanted to have the results yesterday,'
he said. 'We really didn't have the time to do the in- depth review we
wanted to do.'
"Park said Levitt met frequently with Hayes and 'was obviously getting
the pressure to get a resolution and a decision made.'
"With three of five scientists on the commissioner's team opposing
approval, it was decided to bring in a toxicologist for his opinion on
isolated issues [Barry N. Rosloff]. Goyan said if the decision were his,
he never would have enlarged the team.
While the panel did not vote, it ended up split 3-3.
"Levitt, who normally would have been expected to draft an options
paper spelling out scientific evidence on key issues, took an unusual
tack. He circulated an approval recommendation and only backed off when
Dubey, Park, and Condon objected, team members said. Levitt said he was
not directed to draft the approval memo, but did so as a 'tactical' step
to break the team's weeks-long impasse by forcing each scientist to state
his views. 'It worked, didn't it?' said Levitt, who later was promoted
to a post as an executive assistant to the FDA Commissioner."
On July 18, 1981 aspartame was approved for use dry foods by FDA Commissioner
Arthur Hull Hayes, Jr. overruling the Public Board of Inquiry and ignoring
the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C.
348), which says that a food additive should not be approved if tests
In an article in Common Cause Magazine, Florence Graves states that two
FDA officials said that Arthur Hull Hayes, Jr. wanted to push aspartame
approval through in order to signal reforms of the Reagan Administration.
One team member said that during discussions, Hayes, appeared to be abandoning
the agency's traditional standard of "reasonable" proof of safety
and looking for "proof of hazard."
Hayes' July 1981 approval decision came in the face of a Searle threat
to file a suit challenging the regulatory delays.
His ruling relied in part on a late rat study of brain tumors submitted
by Ajinmoto, a Japanese company that manufactures aspartame for Searle.
That study, however, tested Wistar rats, a strain that some scientists
said is more tumor resistant than the Sprague-Dawley rats used in earlier
In his decision, Hayes wrote: "Few compounds have withstood such
detailed testing and the repeated close scrutiny and the process through
which aspartame has gone should provide the public with confidence of
Between 1979 and 1982, four more FDA officials who participated in the
approval process took jobs linked to the NutraSweet industry: Stuart Pape
was the Health and Human Services (HHS) Chief Counsel for Foods; acting
FDA commissioner Sherwin Gardner;
Albert Kolbye, who was associate director of the Bureau of Foods for toxicology,
and Mike Taylor, an FDA lawyer who represented the bureau before the Board
of Inquiry. All four denied any conflict of interest. (Mike Taylor: Deminimus
* Mike Taylor was an FDA lawyer who represented the FDA Bureau of Foods
at the PBOI and was part of the team that prevented the quality and validity
of G.D. Searle's studies from being considered.
* Sherwin Gardner was the Deputy FDA Commissioner in 1979. In July, 1974,
he had signed the initial approval for aspartame's use in dry foods. (This
initial approval was later block by objections from James Turner, Esq.
and Dr. John Olney.)
In December, 1979, Sherwin Gardner became a Vice President of Grocery
Manufacturers of America, Inc. (GAO 1986). While Mr. Garden claims that
he did not discuss aspartame is his 4 meetings with the FDA within a year
of leaving that agency or his 20 meetings with the FDA between 1980 and
1986, the organization he worked for does deal directly with aspartame
products. It is unlikely that he would have been rewarded with the job
had he called for another delay in approval and proposed that safety tests
be conducted independently in order to protect the public.
* Stuart Pape was the Health and Human Services (HHS) Chief Counsel for
Foods from October 1976 to March 1979. He served as special assistant
to the FDA Commissioner from March 1979 to December 1979.
He participated in meetings and discussions on aspartame as well as representing
the FDA at the PBOI.
In December 1979, Mr. Pape was given a job by the law firm of Patton,
Boggs, and Blow. This law firm provided counsel to the National Soft Drink
Mr. Pape and Howard R. Roberts of the NSDA (who formerly fought for approval
of aspartame at the FDA) met with the FDA twice in 1983 where aspartame
was discussed. In 1983, the NSDA inexplicably withdrew their objection
to aspartame in diet beverage (GAO 1986).
* Albert Kolbye was the Associate Director of the FDA Bureau of Foods
In late 1982, Searle petitioned for FDA approval to use the sweetener
in diet soft drinks and children's vitamins. On a day when Hayes was away,
Novitch approved the petition, increasing the acceptable daily intake
level for humans by nearly half, from 34 mg to 50 mg per kilogram of body
Novitch, now in private industry, said he and Hayes had worked together
on the matter, but declined to say why he was left to sign the approval.
Just weeks later, Hayes resigned under the cloud of an internal Dept.
of Health and Human Services investigation into his acceptance of gratuities
from FDA-regulated companies - including free rides aboard jets owned
by a major NutraSweet user, the General Foods Corp.
Shortly after being named Dean of the New York Medical school, Hayes also
became a consultant to the New York-based public relations firm of Burson-Marsteller,
which represents the NutraSweet Co. and several major users.
Hayes' former top spokesman, Wayne Pines, who previously had joined the
firm, said he approached Hayes because he thought him "an added value"
Hayes, now president of the E.M. Pharmaceutical Co. in Hawthorne, N.Y.,
declined comment for this series of articles. He has in the past denied
any impropriety in his consulting role, which sources said paid him more
than $1000. per day.
Burson-Marsteller vice president, Buck Buchwald stressed that Hayes was
not involved in NutraSweet issues and worked but 10 to 15 days a
But a former Burson-Marsteller employee, who requested anonymity, said
Hayes was hired precisely because of his decision on NutraSweet and other
issues affecting company clients.
Sen. Metzenbaum said it was "at the very least...unbecoming, at the
very most, it probably was inappropriate" for Hayes to accept the
In July 1986, Anthony Brunetti, a FDA consumer product officer who drafted
the 1983 notice approving NutraSweet use in soft drinks, also took an
industry job, joining the soft drink association as a science advisor.
Brunetti said he cleared the move with the FDA's ethics officer.
"My situation," he said, "is no different than many, many
people...that go through the revolving door. It can be made to look like
there is some duplicity going on. In terms of my own conscious, I have
Ron Lorentzen, an FDA toxicologist who was asked by current Bureau
of Foods chief Sanford Miller to perform a separate, internal review
of the agency's handling of aspartame, described it as a "tortured"
But despite the myriad questions and revolving door issues, he asserted
the FDA responded to each issue "in a way, perfectly reasonable."
Other questions have arisen over the company and industry's funding of
researchers who have invariably supported NutraSweet's safety - with the
exception of people with the rare disease phenylketonuria. Independent
studies have often raised health concerns.
Dr. Lewis Stegink, a pediatrics professor at the University of Iowa who
repeatedly has produced studies, that he says, support aspartame's safety,
has received more than $1.3 million dollars in research grants and gifts,
including lab equipment, from the (NutraSweet) company since the early
1970's, limited university records show.
Metzenbaum said, "If it is a fact that no questions were raised and
more than a million dollars was spent, you have to wonder whether their
job was done thoroughly as it should be done."
Stegink's longtime research collaborator, Dr. Jack Filer, serves as executive
director of the ILSI (International Life Sciences Institute), the Washington
foundation that funds aspartame research.
Filer said he sees no conflict in his dual roles as ILSI's executive director
and a company researcher, but declined to disclose his ILSI consulting
He said all the Iowa research money has gone to Stegnik. Filer also said
the company (NutraSweet) paid him and Setgnik "$2,000. to $3,000."
to edit a book, "Aspartame," about research on the sweetener,
and another $1,000. or $1,500. to each of the contributors, including
researchers whose studies helped the company win FDA approval. The book
states that "the extensive research program carried out to demonstrate
aspartame safety may serve as a new standard for the study of food additives."
Filer said he had been "maligned over the years for taking money
from corporations," but that the funding source never has influenced
Dr. David Hunninghake of the University of Minnesota was picked to study
aspartame's effect on the liver by former Searle research director Daniel
Azarnoff, once Hunninghake's mentor at the University of Kansas, a Hunninghake
associate said. He said Searle helped design the study.
Susan Schiffman, named to head a Searle-funded Duke University medical
School study into NutraSweet's link to headaches, is a former General
Foods and Searle consultant. Her research at Duke, where the medical school
has a new Searle Center, has fallen under the office of university vice
president William Anylan, a former Searle director. Schiffman said Anylan
had no role in Searle's promise to cover all costs of the study, which
is expected to cost "hundreds of thousands of dollars." She
said she took no salary for her work.
Another industry-backed researcher has been Ann Reynolds, now chancellor
of California State University at Long Beach. Dr. John Olney asserted
that in a 1971 study, Reynolds confirmed his findings that the sweetener
destroyed nerve cells in infant mice, but Searle did not notify the FDA
until 1975 or 1976, after the FDA's initial review.
Dr. Daniel Azarnoff, Searle's former science director, and other Searle
officials have denied withholding any studies from the government.
Reynolds also co-authored a Searle monkey study that contradicted earlier
aspartame research leading to seizures in monkeys. Dr. Olney alleged that
Reynolds, who did not return phone calls, and several other company-funded
researchers "have a pattern of avoiding" scientific peer review.
Industry spokesmen contend that few studies by scientific critics of NutraSweet
have undergone peer review. But few such clinical studies have been completed
because of a funding shortage.
George Liepa, a nutrition professor at Texas Woman's University said he
was required to discuss his findings with Searle before reporting that
NutraSweet "is safe" for diabetics on hemodialysis. Dr. David
Horwitz, an associate professor of medicine at the University of Illinois,
who studied NutraSweet and diabetics, said the company did not influence
the outcome, but, "The results were favorable.... Obviously, that
is perhaps why Searle was eager to fund an additional study of ours."
Dr. Richard Wurtman was an ardent defender of NutraSweet's safety at public
hearings six years ago (1981). Now he is one of the artificial sweetener's
"I think the likelihood is very strong that NutraSweet does produce
serious and potentially damaging brain effects in a number of people,"
the nationally known neuroscientist from Massachusetts Institute of Technology
said in a recent series of interviews.
Wurtman's seemingly enigmatic flip-flop from a position as a G.D. Searle
Co. consultant to a role as a foe urging restrictions on marketing the
firm's best-selling product appears to be much at the center of the controversy
over NutraSweet's safety.
Wurtman says his views simply changed with the evolution of his scientific
studies and his growing skepticism of industries attitude toward research.
His sometimes stormy relationships with the company and an industry-funded
foundation, the ILSI, provide a glimpse of the maneuverings surrounding
research into a major food additive.
Wurtman, a brash-talking, hard-driving head of a major research laboratory,
said he unilaterally severed his consulting relationship with Searle in
1985 after he grew concerned about NutraSweet's effects and the company's
inaction. He said he rejected several
approaches by the firm, (the NutraSweet Co.) since its sale that
year to the Monsanto Corp., to rekindle the consulting arrangement.
Wurtman accuses NutraSweet Co. officials of "misrepresenting"
the nature of company-financed studies into links between the sweetener,
generically known as aspartame, and epileptic seizures, of sidestepping
key safety issues, and of threatening to veto his grant application to
ILSI's aspartame committee. A spokesman for the
NutraSweet Co. described Wurtman's public attacks as a "political
issue," but declined to elaborate.
Wurtman's relationship with Searle, The NutraSweet Co., and many of the
companies that sell NutraSweet-flavored products dates to 1978. Beginning
that year, according to public records, ILSI provided more than $200,000.
to finance his research on caffeine, a common beverage ingredient that
was under FDA scrutiny.
Wurtman said he found no ill health effects during his caffeine research,
and his relationship was "excellent" with ILSI - a spin-off
of the National Soft Drink Association.
During the same period in 1978, he said he rejected a Searle offer of
financial support for research on amino acids. Phenylalanine and aspartic
acid, two such amino acids, are the main components of NutraSweet.
He said Dr. Sanford Miller, chief of FDA's Bureau of Foods, later sought
his testimony before a 1980 Public Board of Inquiry because he openly
stated his belief that neither glutamate nor aspartic acid, a similar
compound to that in NutraSweet, would not cause brain damage. Wurtman
strongly defended aspartame at the hearing.
He said he did not focus on phenylalanine until about 1983, when he learned
the FDA was considering expanding use of the low-calorie sweetener, approved
two years earlier for dry foods, to include carbonated soft drinks.
From his caffeine research, Wurtman said, he was aware of the exploding
soft drink market and concluded "that the use of aspartame was going
to go up considerably."
"I was genuinely concerned that there might be an increase in brain
Wurtman said that, while phenylalanine is vital to the brain, it can serve
as a barrier to 20 other amino acids that provide protein. It is also
a well known neurotoxin. (FROM MARTINI: Dr. Wurtman left quite a paper
trail in the book Dietary Phenylalanine and Brain Function edited by Richard
J. Wurtman and Eva Ritter-Walker, Birkhauser)
WASHINGTON (UPI) In October 1982, Sen. Howell Heflin, D-Ala, proposed
an obscure amendment altering the laws covering U.S. patent extensions,
a move affecting only one company and one product, the artificial sweetener,
Without mentioning aspartame, which is sold under the name NutraSweet,
the senate passed the amendment to the Orphan Drug Act, extending G.D.
Searle Co.'s domestic monopoly on aspartame sales for another five years,
10 months, and 17 days.
"We think it's an excellent amendment," remarked Sen. Orrin
Hatch, R-Utah, wrapping up a five-minute discussion on the Senate floor.
When the House approved the same language a month later, it all but cinched
another $3.5 billion to $4 billion in revenues for the Chicago-based,
Searle. It helped Searle's stockholders sell the company's assets, including
its lucrative NutraSweet division and the two domestic use patents, for
$2.7 billion to the Monsanto Corp. in the summer of 1985.
Sponsors of the measure found their campaign committee, enriched.
Heflin's 1984 reelection committee received contributions totaling at
least $9,000. from Searle's top officers and its political action committee,
more than any others among a long list of Searle beneficiaries in Congress,
federal Election Committee records show.
Hatch's committee received at least $3,000 the records show. Heflin defended
his sponsorship of the measure, saying Searle had been victimized by regulatory
delays that ate up most of its 17-year patent. But a spokesman for the
U.S. Patent Office said Heflin's legislation marked one of only a handful
of instances in the last three decades in which a company's patent has
been extended by a private bill in Congress.
It also provided a glimpse of the adeptness with which Searle, Monsanto,
and their lobbyists have guided the artificial sweetener through the obstacles
of government regulatory bureaucracies to capture big financial rewards.
Headed by Donald Rumsfeld, the former Ford White House Chief of Staff,
Searle repeatedly demonstrated its political acumen on other front, too,
in the years prior to the sale to Monsanto.
In 1981, the company overcame a controversy-snarled, eight-year review
process to win Food and Drug Administration approval for NutraSweet.
In 1984, Searle parried an assault on the sweetener's safety from Arizona
food scientist, Dr. Woodrow Monte, after hiring Arizona Gov. Bruce Babbitt's
former chief of staff as a lobbyist. Searle officers passed along campaign
contributions of $2,000 to a key lawmaker, and the company soon had won
passage of legislation crushing Monte's efforts to force tough state restrictions
on the sweetener.
"I don't know of any company that has apparently covered all of its
bases as well as has Searle," said Sen. Metzenbaum (D-Ohio). "Whether
it has to do with the scientists or lawyers, or non-profit institutions,
or universities, or whatever; in every instance, I have found that they
have expended their dollars very carefully and very wisely, but without
apparent restraint as to the amount."
Indeed, besides Searle's hiring of up to a dozen lobbyists, UPI traced
nearly $200,000. in federal campaign contributions between 1973 and 1986
from its officers and political action committee.
The political intervention in the patent process drew the ire of several
small companies seeking to enter the aspartame market, triggering charges
that a corporate giant benefited from unjustified or preferential treatment.
"I think its obvious they (Searle officials) used political muscle,"
Alan Kligerman, president of Lactaid, Inc., a New Jersey diet food manufacturer,
said of the patent extension. He said his firm had been interested in
manufacturing aspartame until the patent was extended, but "Searle
was well wired in."
"It is possible that they (the Senate) did not know what they were
passing," he said. "I don't know how they got that through,
except with the right phone calls."
"I would not hesitate to say," Metzenbaum said, "that the
manner in which that five-year extension of the patent rights was put
through on the floor of the U.S. Senate was totally inappropriate."
"It should not have been without the entire body being advised that,
that issue was going to be on the floor of the Senate."
Metzenbaum said that the Senate has an "alert" system under
all legislation is cleared with individual senators before it is
brought to the floor, but the system was bypassed.
Jerry Ray, a spokesman for Heflin, asserted the offices of key senators,
including Metzenbaum, approved the measure before it went to the floor.
But Ray offered no explanation for the failure to fully disclose the contents
and impact of the measure.
Ray quoted Heflin, Chairman of the Senate Ethics Committee, is saying
Searle representatives never mentioned campaign contributions in asking
him to sponsor the amendment.
Heflin said he has "supported all patent restoration bills"
because regulatory delays have created "a chronic problem" in
which companies get so little use out of their 17-year patents, they are
reluctant to put money into research.
Heflin said, in Searle's case, "almost 35 percent of the patent term
had been used on a long series of administrative hearings, trials, and
appeals (in) which, in the end, the corporation finally prevailed. To
not restore some of the patent term lost would unfairly penalize them."
G.D. Searle sought an extension of its patent on grounds that the Food
and Drug Administration's handling of its aspartame approval petition
was "an unparalleled instance of unnecessary regulatory delay, which
worked a great injustice to Searle".
Critics argue that, to the contrary, the FDA suspended its 1974 approval
allowing Searle to market the sweetener because of evidence the company's
animal studies were flawed and the results were misrepresented to the
FDA in the early 1970's.
The evidence prompted FDA chief counsel Richard Merrill to ask the U.S.
Attorney's office in Chicago to open a grand jury investigation into possible
fraud by the company.
While a grand jury investigated similar allegations related to Searle
drug products, no such inquiry was ever begun into the aspartame testing.
But the FDA was concerned enough about Searle's research to appoint two
task forces, a university research group, and a Public Board of Inquiry
to review various studies.
In 1981, shortly after taking office, FDA commissioner Arthur Hull Hayes,
Jr. overturned the three-man Board of Inquiry and approved sale of NutraSweet
in dry foods. Two years later, Hayes' deputy, Mark Novitch, approved the
use of aspartame in soft drinks.
Kligerman dismissed as "crap" Searle's contention it had been
victimized by the FDA bureaucracy, which delayed a decision from 1975
"The FDA had reason for doing this," Kligerman said of the intense
review process. "It was not an unnecessary delay. It was Searle's
fault this happened." For Purification Engineering, Inc. of Columbia,
Md., which raised money from private investors and built a plant solely
to manufacture aspartame for Searle, the congressional action ultimately
turned out to be devastating.
Searle officials declined to discussed the patent extension, but a
company lobbyist, former White House official William Timmons, said the
company "felt there was an injustice" in the delays following
aspartame's 1974 approval.
He said the company "took an advocacy role by talking to a lot of
members of Congress".
In May of 1984, FEC records show Heflin's reelection committee additionally
received $1,000 donations each from Daniel Searle, the chief executive
officer of the giant pharmaceutical company; his wife, Dain; William Searle,
Searle's brother who was a company director; William Searle's wife, Sally;
Suzanne Searle Dixon, a sister of the Searles; and her husband, Wesley
Dixon, who also was a company director.
Heflin also received $1,000 from William Searle prior to the general election,
and $2,000 in Searle PAC contributions, FEC records show.
On November 1982, a week after his reelection and a month after praising
the amendment in the Senate chambers, Hatch's committee received $2,000.
in contributions from top Searle officers, the records show.
Sen. Robert Byrd (D-W.Va.), who brought the amendment up for a vote on
Heflin's behalf, also received a $1,000 campaign contribution from Daniel
Searle on Sept. 25, 1981.
Hatch received contributions of $1,000 each from Daniel Searle, Wesley
Dixon, and William Searle on Nov. 11, 1982, days after he was reelected
to a second term in which he continued as chairman of the Labor and Human
Resources Committee that oversees the FDA.
As chairman of the panel until last January, Hatch repeatedly blocked
Sen. Metzenbaum's calls for new hearings into the safety of NutraSweet.
Prior to his reelection, Hatch also received $2,500 in contributions from
the soft drink PAC.
Rep. Henry Waxman (D-Calif.), who sponsored the Orphan Drug Act covering
research for treating rare diseases and who carried Heflin's patent amendment
to the bill in the House, received $1,500 in campaign contributions from
the soft drink PAC, including $500 two days before the measure's introduction
in the House.
Like Heflin, Waxman made no mention of aspartame in describing the Senate
amendments to the drug act on the House floor.
Searle also flashed its political prowess after Arizona scientist Woodrow
Monte stirred up a furor in 1984 by publicly assailing NutraSweet's safety.
The ensuing events, Monte charged, "reflected exactly what Searle
has been doing all along. They've been buying their way into the hearts
and minds of America. They've been using their financial acumen to get
Within months, legislative rules were swept aside one day in early 1985
and, in a swift, subtle maneuver without notice to the public, Monte's
campaign for state regulations on the sweetener was sidetracked.
Monte was a leading national advocate in the drive to block marketing
of NutraSweet until his own credibility was damaged in 1984 with disclosures
he had invested in "put options" that would have earned profits
if Searle's stock dropped. He now concedes his options trading was a mistake,
but denies it influenced his research.
Monte said he was convinced in 1983, when the FDA okayed use of NutraSweet
in carbonated beverages, that the sweetener would break down into poisonous
quantities of methyl alcohol in diet sodas left in the Southwest sun.
Monte, director of the Food Science and Nutrition Laboratories at Arizona
State, and two consumer groups petitioned the Arizona Dept. of Health
Services to ban the sweetener.
Monte said his rat studies had shown that chronic ingestion of methyl
alcohol causes brain damage similar to that in humans suffering from Multiple
Sclerosis, including seizures, amnesia, optic neuritis, numbness, and
dizziness. In the desert heat, Monte said, methanol degrades faster into
toxic methyl alcohol.
Searle and FDA officials have argued that aspartame contains too little
methanol to pose a health hazard. (MARTINI ADDITION: Both
Searle and the FDA know that in molecular chemistry the formula is
one molecule of aspartic acid to one molecule of methanol to one molecule
of phenylalanine. So aspartame liberates 33% free methyl alcohol!!! The
Trocho Study of l998 shows that the formaldehyde converted from this methanol
accumulates in the cells and damages DNA. When you damage DNA you're talking
about survival of the human race!)
When Monte and the consumer groups pressed their legal challenge for more
than a year, Searle flexed its muscle:
The company dispatched a coterie of lobbyists to the state capitol, among
them Andrew Hurwitz, Gov. Babbitt's former Chief of Staff; prominent Arizona
lobbyist Charles Pine; company lawyer Roger Thies, and another company
official, David West.
Between August 23, and Sept. 21, 1984 company officers Daniel Searle and
his brother-in-law, Wesley Dixon, each contributed $1,000. to the campaign
of State House Majority Leader Burton Barr, later a GOP candidate for
governor, reports to the Arizona Secretary of State's office records show.
Campaign disclosure forms show revealed that, during the same period,
several House Republicans received contributions from the Committee to
reelect Barr, including State Reps. Don Aldridge, Karen Mills, and Jan
Brewer, all among the Health Committee members who voted 13-0 to pass
the measure affecting NutraSweet.
The trio received $1,500, $1,000 and $750 respectively from Barr, who
for years has enhanced his influence by donating to colleagues' campaigns.
Barr and Arizona State University Regent William Reilly contacted the
school's president, J. Russell Nelson, and Academic Vice President Jack
Kinsinger to inquire into Monte's public attacks on NutraSweet, published
reports said. Kinsinger insisted that the issue caused no delay in his
decision to grant Monte tenure. Barr did not return phone calls.
When Monte's first petition was rejected and he filed for reconsideration,
Hurwitz (Searle) wrote a letter offering legal advice to the Dept. of
Health Services (DHS) about its response, and sent copies to Barr and
aides to Gov. Babbitt.
In April of 1985, about the same time Monte and his associates finally
were to be granted a hearing before the state agency on their petition,
they learned that the Arizona Legislature had used a rare maneuver to
change the law, without public notice to bar state regulation of FDA-approved
food additives. The measure passed under the misleading title of a toxic
Monte's campaign to ban NutraSweet in Arizona prompted the State
Dept. of Health Services to conduct a study to determine how much
NutraSweet soft drinks degraded in high-temperature conditions. The
study, completed in July 1984, found that methanol levels were
highest (9.4 ppm), in Diet 7-Up samples stored the longest time in
the warmest temperature, 99o F heat.
Present and former Arizona state officials have told UPI that the study
concerned DHS officials enough that they discussed a NutraSweet ban.
But Norman Peterson, manager of the DHS's Office of Chronic Disease and
Environmental Health Services, said that the agency concluded that "the
FDA address the methyl alcohol question and had all sorts of supporting
data. We had no basis for saying that the data they had presented in support
was not correct or adequate."
Another source said Peterson was distressed enough that, during a meeting
attended by DHS director Donald Mathis, he proposed being allowed to recommend
that pregnant woman, and children, limit their consumption of NutraSweet.
Peterson would not confirm the episode, but recalled that he "was
upset about the fact that there were so many unanswered questions".
Mathis, who since left the agency, said he was satisfied that it "wouldn't
be humanly possible" to ingest levels of NutraSweet that would produce
a toxic reaction.
In September 1984, Monte and his associates file suit to force the DHS
to impose storage and labeling requirements or ban NutraSweet altogether.
But a proposed settlement under which the agency would hold a public hearing
was scuttled because it lacked the approval of Mathis' successor, Lloyd
Novick. After more negotiations, the DHS agreed to hold a hearing. But
before it could take place, the issue was killed by the legislative change.
House Speaker James Sossaman later admitted that the GOP-controlled House
violated its own rules in passing a so-called "strike all" amendment.
Chairman Bart Baker of the Health Committee engineered the action, in
which an existing bill was stripped, replaced with the NutraSweet language
and brought to a vote without the required 24 hours public notice.
For Monte, the development was all the more staggering after he had gotten
into a jam over his stock purchase. Monte said that, after reviewing files
at the FDA and consulting with his lawyer in 1983,
he invested less than $2,000 on Searle options, hoping to raise
money to support his costly legal battles against the sweetener. He said
he ended up losing $1,224.
Lawyer Rick Faerber also invested in part, he said, because of Monte's
knowledge of an upcoming CBS story critical of the FDA's approval of aspartame.
He said stock analysts had phoned Monte inquiring about his Arizona petitions
and apparently got the idea the developments would depress the stock value.
Faerber said he regrets telling Monte that he "didn't think there
was anything wrong" with investing, particularly because pro-NutraSweet
forces apparently learned of their dealings. CBS employees also bought
"put options" but a Securities and Exchange Commission investigation
did not lead to any charges.
Shortly after news stories about the investment appeared, Rep. Bob McEwen,
(R-Ohio), assailed CBS and Monte for "irresponsible reporting and
conflicts of interest" in a brief speech on the floor of the U.S.
McEwen charged that the "false report" about NutraSweet was
aired solely for profit.
But ion his speech, Rep. McEwen did not mention that his top assistant
Charles Greener, is the son of William Greener, Jr., Searle's vice president
for corporate communications.
Charles Greener who said he was "unaware" of Rep. McEwen's floor
speech until after it occurred, said his father never has handled NutraSweet
matters and that McEwen did not know any Searle officials.
The success of the Searle family business, founded 80 years ago, is all
the more astounding when compared to the company's predicament in 1977
when it plucked Rumsfeld as its president. Facing a company mired in debt,
Rumsfeld, a native Chicagoan and former Illinois congressman, quickly
hired three other outgoing Ford Administration officials to join him.
As executive vice president, he named John Robson, a former partner in
the law firm of Sidley & Austin who had served as President Ford's
chairman of the Civil Aeronautics Board. Robert Shapiro, Robson's special
assistant at the Transportation Department, was tapped as general counsel.
Rumsfeld also hired William Greener, Sr., who had been a spokesman in
the Ford White House and Rumsfeld's chief spokesman at the Pentagon.
The pharmaceutical company suddenly was being run by lawyers and politicians.
Stomaching a $28 million net loss in his first year, Rumsfeld slashed
Searle's operations, selling off more than 30 subsidiaries worth more
than $400 million. Before Rumsfeld could mount a full scale effort to
lift a FDA freeze on the sale of NutraSweet, Searle was hit with serious
Suits filed on behalf of 780 women, alleged the company's Copper 7 intrauterine
device had caused them to develop pelvic inflammatory disease, an infection
of the reproductive tract that can lead to sterility, even death. Before
the suits could be settled, Searle sold out to Monsanto.
The huge, St. Louis-based chemical company and its officers were promptly
met with stockholder suits alleging they had failed to explore potential
safety problems with Searle's biggest moneymakers- Copper 7 IUD and NutraSweet.
Rejecting criticism of the acquisition, Earl Harbison, Jr., executive
vice president of Monsanto and Chairman of the Board of its Searle pharmaceutical
subsidiary, said in October 1985, that Monsanto "studied this situation
(Copper 7 litigation) very closely prior to acquiring Searle, including
consultations with independent physicians".
"We satisfied ourselves with the safety and efficacy of the product,"
he said. Since then, Copper 7 has been pulled off the market. Some lawyers
likened the resulting legal morass to the failure of the Dalkon Shield
that drove the Richmond-based A.H. Robins Co. into Chapter 11 bankruptcy
But a former Monsanto official, who requested anonymity, said that as
part of the sale agreement, Searle set aside reserves to cover the IUD
lawsuits. Thanks to NutraSweet, Searle family members Daniel and William
Searle and their sister, Suzanne Searle Dixon, to date appear to have
walked away unscathed from all the crises and legal battles.
And even if NutraSweet were proved hazardous, the purchase agreement provided
"no escrow, reserve or holdback for liability stemming from the potential
health hazards attributed to the NutraSweet product line," says one
lawsuit filed by Chicago lawyer Robert Holstein on behalf of a Monsanto
And Rumsfeld emerged from his nine years with the company in solid financial
condition. Securities and Exchange Commission records show that for his
guiding the sweeping turnaround, he earned more than $2 million in salaries
and more than $1.5 million in bonuses between 1979 and 1984.
"Banana plants don't make NutraSweet," the television announcer
noted wryly, and the image of an exotic bird perched in a jungle tree
filled the screen. "Neither do cows," said the voice, as the
camera cut to a robust-looking heifer wagging its tail. "But they
might as well. If you've had bananas and milk, you've eaten what's in
True, bananas, milk and NutraSweet all contain phenylalanine, one of 21
amino acids that form the "building blocks" of protein. But
that doesn't tell the whole story.
Dr. Richard Wurtman, a neuroscientist at the Massachusetts Institute of
Technology, says that because NutraSweet lacks other important amino acids
normally found in foods, the brain absorbs unusually high levels of phenylalanine
that could increase the likelihood of epileptic seizures.
Referring to an ad proclaiming that the body treats the ingredient of
the artificial sweetener "no differently than if they came from a
peach or a string bean or a glass of milk," Wurtman said, "That's
Dr. Louis Elsas, director of medical genetics at Emory University, groans
at the industry arguments that eating or drinking NutraSweet (aspartame)
is just like eating a hamburger.
"Phenylalanine is a known toxin to the brain,' Elsas said. "Aspartame
is phenylalanine, and drinking aspartame is like drinking phenylalanine
as an individual amino acid."
A spokeswoman at the New York offices of Ogilvy and Mather, the lead ad
agency on the sweetener account for the Chicago-based NutraSweet Co.,
declined comment on the allegation. The drumbeat of NutraSweet advertisements
has been steady. Beverage Industry, a trade publication, labeled the NutraSweet
blitz "probably the largest advertising campaign ever designed around
a product ingredient."
Industry sources say that since 1984, The NutraSweet Co. alone has spent
$30 million to $40 million per year on advertising, and ads by diet soft
drink manufacturers and other companies, who's products carry the swirl
trademark of the sugar-free sweetener, would easily send that the figure
past $100 million a year.
If you've taken the time to read this important report, you may just add
years to your life, save thousands of dollars on medical costs and millions
in anguish and hurt, if you would Just heed the information within these
R. Flint @ http://www.greatfallspro.com/
(Mission Possible/Maine )