- 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 1969):
- "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
- 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 phenylalanine-methyl ester.
- Aspartame (C14H18N2O5 ) is a compound of three components.
These components are methanol, aspartic acid and phenylalanine
(the latter being free form amino acids).
- 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
- 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 blood-brain
- 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
- 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
- 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 applications.
- 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 study.
- 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
- 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 infant mice.
- 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
- 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 (1973).
- 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.
- 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.
- 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
- "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
- 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 of
- Ajinomoto is the inventor and main producer of the food
- 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 provided.
- Such deficiencies in each area of required information
precluded a scientific evaluation of the clinical safety of this
- 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
- 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
- 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
- "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 now."
- 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 the inquiries."
- 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
- "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
- 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,' Schmidt said."
- G.D. Searle executives admitted to "payments to employees of
certain foreign governments to obtain sales of their products."
- 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
- 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 task."
- 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 Register 1975).
- 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
- 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
- A few of the conclusions of the FDA Task Force (Gross 1987a,
- "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
- 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
- "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
- * "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, page S10835)
- * "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
- * "In each study investigated, poor practices, inaccuracies,
and discrepancies were noted in the antemortem phases which
could compromise the study."
- * "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
- 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
- "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
- * [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
- "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 studies.
- 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
- "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 was reprehensible."
- 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 Record 1985a):
- "[All tests were] scientifically irresponsible [and]
- 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
- "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 following reasons:
- * 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
- * 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
- * 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
- According the FDA Commissioner during the early 1980s,
Arthur Hull Hayes, the UAREP investigation was to "make sure
that the studies were actually conducted."
- 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
- 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 of Transportation.
- 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 Transportation.
- 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
- 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 38th week.
- 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 1987;
- 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
- 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 examinations.
- * 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
- * An outbreak of an infectious disease was not reported to
- * 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
- * Sections from the animals were too thick for examination.
- * There was no documentation on the age or source of the
- * There was no protocol until one of the studies was well
- * Animals were not permanently tagged to prevent mix-ups.
- * Some laboratory methods were changed during the study, but
- A G.D. Searle pathologist referring to the DKP study was
quoted by investigators as saying:
- "You should have seen things when this study was run --
there were five studies being run at one time -- things were a
- The leader of the Task Force, Jerome Bressler, was quoted as
- "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,
- 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
- 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," he said.
- 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
- 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
- In her testimony before the U.S. Senate, Dr. Verrett stated
the following (Verrett 1987):
- "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 been derived.
- "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
- 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" their studies.
- 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 such tumors.
- 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 Register 1981):
- * 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
- 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
- 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
- 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,
- "[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 supply?"
- 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
- 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
- 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
- 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 aspartame.
- 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
- "[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
- "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
- 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 are inconclusive.
- 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 research.
- 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 its safety."
- 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
- 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
- * 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
- * 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
- 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 Association (NSDA).
- 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 for toxicology.
- 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 weight.
- 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" to clients.
- 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
- Sen. Metzenbaum said it was "at the very least...unbecoming,
at the very most, it probably was inappropriate" for Hayes to
accept the position.
- 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 no problem."
- 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
- But despite the myriad questions and revolving door issues,
he asserted the FDA responded to each issue "in a way, perfectly
- 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
- 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
- Stegink's longtime research collaborator, Dr. Jack Filer,
serves as executive director of the ILSI (International Life
Sciences Institute), the Washington foundation that funds
- 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 fees.
- 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 his findings.
- 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
- 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 harshest critics.
- "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
- 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
- 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
- approaches by the firm, (the NutraSweet Co.) since its sale
- year to the Monsanto Corp., to rekindle the consulting
- 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
- 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
- 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
- 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 phenylalanine levels."
- 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, aspartame.
- 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
- 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,
- 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
- 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
- "It should not have been without the entire body being
advised that, that issue was going to be on the floor of the
- Metzenbaum said that the Senate has an "alert" system under
- all legislation is cleared with individual senators before
- 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
- 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
- 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
- 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
- Kligerman dismissed as "crap" Searle's contention it had
been victimized by the FDA bureaucracy, which delayed a decision
from 1975 to 1981.
- "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
- Searle officials declined to discussed the patent extension,
- company lobbyist, former White House official William
Timmons, said the company "felt there was an injustice" in the
- 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
- 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
- Like Heflin, Waxman made no mention of aspartame in
describing the Senate amendments to the drug act on the House
- 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 their way."
- 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
- 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
- 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 waste bill.
- Monte's campaign to ban NutraSweet in Arizona prompted the
- Dept. of Health Services to conduct a study to determine how
- NutraSweet soft drinks degraded in high-temperature
- study, completed in July 1984, found that methanol levels
- highest (9.4 ppm), in Diet 7-Up samples stored the longest
- 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
- 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
- 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
- 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
- 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. Senate.
- 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
- 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 new
- 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
- "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 protection.
- 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 stockholder.
- 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 NutraSweet."
- 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 not true."
- 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 texts.
- R. Flint @
- (Mission Possible/Maine )