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Sun Apr 10 21:05:06 EST 2005


"It was not anticipated that this investigation alone could definately 
establish whether ingestion of aspartame-containing products did or did 
not cause the symptoms reported."
...
"The number of instances of persons challenging themselves several times 
with aspartame-containing products and reporting symptoms with each 
rechallenge suggests that some individuals may be sensitive.  The only 
way to clearly determine this is through focused clinical studies.  
Because of the number of reports, the subtlety and potential seriousness 
of some of the manifestations, the concerns of some scientists, and the 
possibility that one complainant has had his symtpoms of hyperactivity 
verified on independent exam, it would seem that the highest priority for 
any future investigations might be in the neurological/behavioral area, 
focusing on such symptoms as headaches, mood alterations, and behavior 
changes."
etc.

It is also important to note that aspartame did not appear in diet 
beverages until 1984 and it wasn't until after 1987 that many people 
started ingesting significant amounts.  A large number of people are now 
reporting serious problems with long-term ingestion of aspartame.

:  Moreover, the FDA and WHO organization have set "maximum 
: safe consumption levels" of aspartame based on a small proportion of the
: doses that are unsafe in rats.  These doses are 40-50 mg/kg/d.  Recent
: examinations of use show that 90% of users fall below 2 mg/kg/d and
: nearly all fall below 10 mg/kg/d, indicating that the actual use of
: the sweetener is even safer than what is reported by the FDA, which assumes
: much higher consumption levels. 

You are reading those lousy NutraSweet surveys of aspartame "usage."  
These surveys are laughable, at best.  One survey actually has the gall 
to claim that the aspartame consumption for 6-12 year olds was shown to 
*decrease* significantly from 1984 (the year that aspartame appeared in 
carbonated beverages) to 1989, despite the nearly tripling of sales of 
aspartame from the middle of 1984 to 1989.  Some of their surveys show a 
higher aspartame consumption in the Winter than the hot Summer months.  
Another one of their reviews claims that Canada has an aspartame 
consumption rate many times what it is in the U.S.  Other surveys from 
NutraSweet use data from a *1977-1978* US food consumption survey to 
calculate aspartame intake.  These surveys also never take into account 
the fact that people often forget their snacks that they ingested.

These "surveys" disagree with their own controlled studies.  In a study 
conducted by Searle, children who were allowed to ingest 
aspartame-containing products ingested as much as 76 mg/kg/day of 
aspartame.  (See J. of Toxicology and Environmental Health, 2: 401-415.)
Three studies of obese individuals showed that they ingested anywhere 
from 8 to 36 mg/kg/day of aspartame.  (See "Aspartame: Physiology and 
Biochemistry," Marcel Dekker, Inc., N.Y., page 273-286.)

It is quite common for people to drink large amount of aspartame.  I have 
encountered several people on the Net who ingest from 2 to 5 liters per 
day plus other aspartame-containing products.  Several people who are 
addicted to aspartame (i.e., get withdrawl symptoms) have written to me 
for help getting off of aspartame.  Since about 1987, NutraSweet has been 
pushing these "surveys" in order to have an excuse for testing only small 
amounts of aspartame.  Since their own experiments show children 
ingesting way over the FDA's Acceptable Daily Intake (ADI) limit and adjust 
ingesting two-thirds of that limit, all aspartame tests should be at the 
absolute minimum of the FDA's ADI (if not double that value to provide a 
safety cushion).

: You might try examining some of these reviews, e.g.:
: 
: Tollefson L; Barnard RJ.
:      An analysis of FDA passive surveillance reports of seizures
: associated with consumption of aspartame.
:     Journal of the American Dietetic Association, 1992 May, 92(5):598-601.
: 
: Butchko HH; Kotsonis FN.
:       Acceptable daily intake vs actual intake: the aspartame example.
:     Journal of the American College of Nutrition, 1991 Jun, 10(3):258-66.
: 
: Butchko HH; Tschanz C; Kotsonis FN.
:       Postmarketing surveillance of food additives.
:     Regulatory Toxicology and Pharmacology, 1994 Aug, 20(1 Pt 1):105-18.

Two of these "reports" are written directly by NutraSweet.  If you want
NutraSweet PR, filled with errors, then I strongly suggest reading these 
reports.  On the other hand, you may want to read *independent* reviews of 
the subject.  Once you do, you will see how really bad these reports are.

: You should be especially critical of reports which come as case reports,
: since most of the time, the disorder is not actually causally linked
: to the problem the person reports (this is the case for most side effects
: reported at less than 2-3%).  Most of the studies are published in
: established refereed journals, and they generally do not publish
: reports by a company about their own product (although there are avenues
: for this kind of report too).

You are being naive here.  Two of the reports you cited were done by 
NutraSweet.  A very large number of aspartame-related studies are done by 
NutraSweet consultants (or former consultants) and appear in "established 
refereed journals."  

"Despite this system [peer review], anyone who reads journals widely and 
critically is forced to realize that there are scarcely any bars to eventual 
publication," wrote Drummond Rennie, professor of medicine at the 
University of California at San Francisco.  "There seems to be no study 
too fragmented, no hypothesis to trivial, no literature too biased or too 
egotistical, no design too warped, no methodology too bungled, no 
presentation of results too inaccurate, too obscure and too 
contradictory, no alalysis too self-serving, no argument too circular, no 
conclusions too trifling or too unjustified, and no grammer and syntax 
too offensive for a paper to end up in print."  [Cynthia Crossen:  
"Tained Truth"]

You will find all of this and more if you are open-minded enough to look 
closely at the aspartame research.

: In any case, I would trust any double-blind
: report above any case report even if it was done by the company.

I believe that you are being naive here too.  Just because a study is 
"double-blind" doesn't mean it is designed or conducted properly.  For a 
simple example, I have a letter written to FASEB on an issue closely 
linked to the aspartame issue where the manufacturer admits that since 
1978 a reactive substance, similar to that being tested, was used in the 
beverage mixture of double-blind experiments.  There are quite a number 
of major design flaws that can render double-blind experiments worthless.

: Finally,
: the company which developed Nutrasweet (GD Searle) is an experienced
: and respected pharmaceutical company, not a tobacco company, and definitely
: does not have the political ties to hide something as scandalous as you
: are suggesting.

Well, I'm sure the tobacco companies where "respected tobacco comapnies" 
at one time.  I am taking no position on G.D. Searle *today* since they are 
not directly involved in aspartame any longer.  (When Monsanto bought G.D. 
Searle, they gave aspartame to a separate subsidery -- NutraSweet Company.)

Please don't forget to read the enclosure to find out more about the 
pre-approval tests.

Best regards,

- Mark
mgold at tiac.net

P.S. -- I was simply offering to help open-minded researchers look beyond 
the industry PR and look at work done by independent researchers.  I can 
only speak for myself and do not know (or care) what was posted to 
alt.mindcontrol.

P.P.S. -- The growing number and seriousness of the problems caused or 
contributed to by aspartame have led a number of patient groups to 
strongly recommend against the stuff.  It would be a sad sight if the 
"real researchers" (who have not been involved in this issue in the past) 
are the last ones to "discover" the danger.

---------------------------
    BEGIN ENCLOSURE
---------------------------


History of Aspartame
--------------------

1964
----
The development of new pharmaceuticals was the focus of
research at the international pharmaceutical company, G.D.
Searle and Company (Farber 1989). The 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 (Stenik 1984,
page 3).

1965
----
In 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 bumped
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 1984, page 4). The discovery was reported in
1966, but there was no mention of the sweetness (Furia
1972).

1969
----
The investigators first report the discovery of the
artificial sweetener in the Journal of the American Chemical
Society stating (Mazur 1969):

     "We wish to report another accidental disvoery of
     an organic compound with a profound sucrose (table
     sugar) like taste . . . Prelminary tasting showed
     this compound to have a potency of 100-200 times
     sucrose depending on concentration and on what
     other flavors are present and to be devoid of
     unpleasant aftertaste."

---------------

G.D. Searle approached Dr. Harry Waisman (Biochemist,
Professor of Pediatrics, Director of the University of
Wisconsin's Joseph P. Kennedy Jr. Memorial Laboroatory of
Mental Retardation Research) to conduct a study of the
effects of Phenylketonuria (PKU) on primates.Seven infant
monkeys were given aspartame with milk. One died after 300
days. Five others (out of seven total) had grad mal
seizures. These results were hidden from the FDA when G.D.
Searle submitted its initial applications (Stoddard 1995,
Congrtessional Record 1985b, page S10831, US Senate 1976b,
page 373). Dr. Waisman died unexpectedly in 1971 before
completing all of his studies.

---------------

In 1969, former Commissioner of the FDA, Dr. Herbert L. Ley
was quoted as follows (Mullarkey 1992):

     "The thing that bugs me is that people think the
     Food and Drug Administration (FDA) is protecting
     them--it isn't. What the FDA is doing and what the
     public thinks it's doing are as different as night
     and day."

1970
----
The discovery of aspartame is reported in the well-known
publication, Science (Cloninger 1970).

---------------

Neuroscientist and researcher John W. Olney finds that oral
intake of glutamate, aspartate and cysteine, all excitotoxic
amino acids cause brain damage in mice (Olney 1970).

---------------

An internal G.D. Searle memo lays out the strategy for
getting aspartame approved (US Senate 1976a, page 16):

     At this meeting [with FDA officials], the basic
     philospohy of our approach to food and drugs
     should be to try to get them to say "Yes," to rank
     the things that we are going to ask for so we are
     putting first those questions we would like to get
     a "yes" to, even if we have to throw some in that
     have no significance to us, other than putting
     them in a yes saying habit.
     
     We must create affirmative atmosphere in our
     dealing with them. It would help if we can get
     them or get their people involved to do us any
     such favors. This would also help bring them into
     subconscious spirit of participation.

---------------

The FDA bans the sweetener cyclamate. Robert Scheuplein, who
was the acting Director of FDA's Toxicological Services
Center for Food Safety and Applied Nutrition was quoted as
saying "the decision was more a matter of politics than
science." (Stoddard 1995)

1971
----
Ann Reynolds, a researcher who was hired by G.D. Searle and
who has done research for the Glutamate (MSG) Association,
confirmed aspartame's neurotoxicity in infant mice (Reynolds 1971).

---------------

Dr. John W. Olney informs G.D. Searle that aspartic acid
caused holes in the brains of mice. 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 (Stoddard 1995).

1972
----
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.


1973
----
On March 5, 1973, G.D. Searle's petition to the FDA for
approval to market aspartame as a sweetening agent with
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 Departement.
Instead of submitting these alarming findings to the
FDA, G.D. Searle contracted with another pathologist,
Dr. Donald A. Willigan. He was given 1,000 slides to
examine. The Willigan Report was more to G.D. Searle's
liking because it revealed a statistically significant
increase in thyroid and testes tumors, but not in liver
tumors. Liver tumors are of much more concern to the

FDA. The Willigan Report was immediately submitted to
the FDA. G.D. Searle did not disclose the MBR Report to
the FDA until July 1975, 27 months after it had been
given to G.D. Searle.

---------------

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-occuring amino acids could harm
someone in relatively small amounts...." (Mullarkey 1992)

---------------

In an FDA memorandum dated August 20, 1973, Martha M.
Freeman, M.D. of the FDA Division of Metabolic and Endocrine
Drug Products addressed the adequecy of the information
submited by G.D. Searle in their petition to approve
aspartame (US Senate 1987, page 326-336):

     "Although it was stated that studies were also
     performed with diketopiperazine [DKP] an impurity
     which results from acid hydrolysis of Aspartame,
     no data are provided on this product."

Commenting on one particular single dose study:

     "It is not feasible to extrapolate results of such
     single dose testing to the likely condition of use
     of Aspartame as an artificial sweetener."

It is important to note that Dr. Freeman pointed out the
inadequency of single-dose tests of aspartame as early as
1973. 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 nor 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
     bioaviliability 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
(Graves 1984).

---------------

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). In the 1973 G.D.
Searle Annual Report, an executive stated that "commercial
quanities of the sweetener will be supplied from the
enlarged facility of Ajinomoto." Ajinomoto is the inventor
and main producer of the food additive MSG.


1974
----
Ninety of the 113 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).

---------------

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 infromation or preclinical data  were
provided. Such deficiencies in each area of required
infromation precluded a scientific evaluation of the clinica
safety of this pr
oduct...." (Mullarkey 1992, page 23)

---------------

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 representatives claim that Olney's
data raises no health concerns (Stoddard 1995, Farber 1989).

---------------

The FDA approved aspartame for limited use on July 26, 1974.
The allowable uses included free-flowing sugar substitute,
tablets for sweetening hot beverages, cereals, gum, and dry
bases (Farber 1989). 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.

---------------

In August 1974, before aspartame could go on the market, Dr.
John Olney, James Turner, and Label Inc. (Legal Action for
Buyers' Education and Labeling) filed a formal objection
stating that they believe aspartame could cause brain
damage. They were particularly worried about aspartame's
effects on children (Graves 1984).

---------------

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 (Graves 1984, Stoddard 1995).


1975
----
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 were the responsibility of the Pathology-
Toxicology Department at G.D. Searle. (US Senate 1987, page
430). 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 (1984) reprinted in the
Congressional Record (1985a, page S5499):

     "Before the tast force had completed its
     investigation in 1976, Searle had submitted the
     vast majority of the more than 100 tests it
     ultimately gave the FDA in an effort to get
     aspartame approved. These included all test ever
     described as 'pivotal' by the FDA. About half the
     pivotal tests were done at Searle; about one-third
     were done at Hazleton Laboratories. 'Pivotal'
     tests include long-term (two-year) tests such as
     those done to determine whether aspartame might
     cause cancer. Former FDA commissioner Alexander
     Schmidt said in a recent interview that if a
     pivotal test is found to be unreliable, it must be
     repeated 'Some studies are more important than
     others, and they have to be done impeccably,'
     Schmidt said."

---------------

G.D. Searle executives admit to "payments to employees of
certain foreign governments to obtain sales of their
products." (Searle 1975)

---------------

The Investigative Task Force discovers that G.D. Searle
withheld information from the FDA, including the 1969 study
by Dr. Harry Waisman showing that aspartame caused seizures
in infant primates. G.D. Searle responds that Dr. Waisman
was an independent researcher and therefore his tests were
not valid (Stoddard 1995).

---------------

On July 10, 1975, Senator Edward Kennedy chairs a heaing 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).

---------------

On December 5, 1975, Dr. John Olney and James Turner waive
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 1981,
page 286, Mullarkey 1994b).

---------------

On December 5, 1975, the FDA puts 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
(Mullarkey 1994b, Federal Register 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 alledging 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).


1976
----
On January 7, 1976, G.D. Searle submits to the FDA their
proposal for the adoption of "Good Laboratory Practices" (US
Senate 1976a, page 185). G.D. Searle's input was used in
FDA's adoption of Good Laboratory Practices.

---------------

In March 1976, the Task Force submits a 500-page report with
15,000 pages of exhibits (80-page summary) to the FDA after
completing their investigation.

---------------

A preliminary statement about the breadth of the
investigation from FDA Toxicologist and Task Force team
member, Dr. Andrian Gross before the US Senate (1987, page
430-431).

     "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 tehnicians,
     professional workers and supervisors, and the
     nature of such studies does not differ much
     whether a food additive or a drug product is being
     tested for safety in laboratory animals. It is in
     this sense, therefore, that the overall conclusion
     summarized at the beginning of the Searle Task
     Force Report have relevance to all the studies
     audited in 1975 (whether they had references to
     aspartame or to any of the six drug products of
     Searle's) and, by extension, to the totality of
     experimental studies carried out by that firm
     around that time -- 1968 to 1975."

A few of the conclusions of the FDA Task Force:

     "At the heart of FDA's regulatory process is its
     ability to rely upon the integrity of the basic
     safety data submitted by sponsors of regulated
     products. Our investigation clearly demonstrates
     that, in the (case of the) GD Searle Company, we
     have no basis for such reliance now."

     "We have noted that Searle has not submitted all
     the facts of experiments to FDA, retaining unto
     itself the unpermitted option of filtering,
     interpreting, and not submitting information which
     we would consider material to the safety
     evaluation of the product . . . Finally, we have
     found instances of irrelevant or unproductive
     animal research where experiments have been poorly
     conceived, carelessly executed, or inaccurately
     analyzed or reported."

     "Some of our findings suggest an attitude of
     disregard for FDA's mission of protection of the
     public health by selectively reporting the results
     of studies in a manner which allay the concerns of
     questions of an FDA reviewer."

     "Unreliability in Searle's animal research does
     not imply, however, that its animal studies have
     provided no useful information on the safety of
     its products. Poorly controlled experiments
     containing random errors blur the differences
     between treated and control animals and increase
     the difficulty of discriminating between the two
     populations to detect a product induced effect. A
     positive finding of toxicity in the test animals
     in a poorly controlled study provides a reasonable
     lower bound on the true toxicity of the substance.
     The agency must be free to conclude that the
     results from such a study, while admittedly
     imprecise as to incidence or severity of the
     untoward effect, cannot be overlooked in arriving
     at a decision concerning the toxic potential of
     the product."

A few of the relevant findings summarized from various
documents describing the FDA Task Force Report:

     a. "Excising masses (tumors) from live animals,
        in some cases without histologic examination
        of the masses, in others without reporting
        them to the FDA." (US Senate 1976b, page 4)
        Searle's representatives, when caught and
        questioned on these irregularities, stated
        that "these masses were in the head and neck
        areas and prevented the animals from feeding."
        (Stoddard 1995, page 8)
     
        "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." US Senate 1987, page 437).

     b. G.D. Searle "stored animal tissues in
        formaldehyde for so long that they
        deteriorated." (Gordon 1987)
     
     c. "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)
     
     d. "Reporting animals as unavailable for necropsy
        when, in fact, records indicate that the
        animals were available but Searle choose not
        to purchase them."
        (US Senate 1976b, page 5)
     
     e. Animals which had died were sometimes recorded
        as being alive and vica versa. "These include
        approximately 20 instances of animals reported
        as dead and then reported as having vital
        signs normal again at subsequent observation
        periods."
        (Congressional Record 1985b, page S10836)
   
  
     f. "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."
        (US Senate 1976b, page 4)
     
     g. G.D. Searle told the FDA that 12 lots of DKP
        were manufacturered and tested in one study,
        yet only seven batches were actually made.
        (Congressional Record 1985b, page S10835)
     
     h. "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."
        (Congressional Record 1985b, page S10835)
     
     i. "It is significant to note that the Searle
        employee responsible for reviewing most of the
        reproduction studies had only one year of
        prior experience, working on population
        dynamics of cotton tail rabbits while employed
        by Illinois Wildlife Service. In order to
        prepare him for this title of 'Senior Research
        Assistant in Teratology' (fetal damage) Searle
        bought him books to read on the subject and
        also sent him to a meeting of the Teratology
        Society. This qualified him to submit 18 of
        the initial tests to the FDA, in addition to
        training an assistant and 2 technicians. He
        certainly must have kept them busy because
        Searle claimed that 329 teratology
        examinations were conducted in just 2 days. He
        estimated that he himself examined about 30
        fetuses a day, but officials for the Center
        for Food and Applied Nutrition could never
        determine how that was possible."
        (Stoddard 1995, page 9, Congressional Record
        1985a, page S5500)
     
     j. "In each study investigated, poor practices,
        inaccuracies, and discrepancies were noted in
        the antemortem phases which could compromise
        the study."
        (Congressional Record 1985b, page S10836)
     
     k. "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."
        (US Senate 1976b, page 4-5)
     
     l. Animals were not removed from the room during
        the twice per month exterminator sprayings.
        (Congressional Record 1985b, page S10836)
     
     m. Often the substance being tested which was
        given to the animals was not analyzed or
        tested for homogeneity. "No records were found
        to indicate that any treatment mixtures used
        in the studies were ever tested or assayed for
        pesticide content . . . Running inventory
        records for either treatment mixtures or the
        test compounds used in treatment mixtures are
        not maintained."
        (Congressional Record 1985b, page S10836)
     
     n. 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.
        (Congressional Record 1985b, page S10837)
     
     o. "Contrary to protocol, slides were not
        prepared of this [unusual lesions from the
        Aspartame (DKP) study) tissue for microscopic
        examinstions . . . ."
        (Congressional Record 1985b, page S10837)
     
     p. "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."
     
            "It is appraent 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)."
            (Congressional Record 1985b, page S10838)

     q. "Searle technical personnel failed to adhere
        to protocols, make accurate observations, sign
        and date records, and accurately administer
        the product under test and proper lab
        procedures."
        (Farber 1989)
     
FDA Toxicologist and Task Force member, Dr. Andrian Gross as
quoted in the Congressional Record (1985b, page S10826):

     "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 (Graves 1984).

The report quotes 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 repreductive studies submitted to the FDA
(Congresssional Record 1985b, page S10838):

     "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."

The FDA Commissioner at the time, Alexander Schmidt stated
(Graves 1984):

     "[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 (Graves 1984):

     "[All tests were] scientifically irresponsible
     [and] disgraceful. I'm just shocked that that kind
     of sloppy [work] would even be sent to FDA, and
     that the FDA administrators accepted it. There is
     no reason why these tests couldn't have been
     carried out correctly. It's not that we are
     talking about some great scientific breakthrough
     in methodology."

Senator Edward Kennedy at the April 8, 1976 hearings before
the Senate Subcommittee on Labor and Public Welfare stated
(US Senate 1976b, page 1):

     "The extensive nature of the almost unbelievable
     range of abuses discovered by the FDA on several
     major Searle products is profoundly disturbing."

---------------

A series of poorly conceived, flawed studies funded by G.D.
Searle are published in volume 2 (1976) of the Journal of
Toxicology and Environmental Health. The 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. Tephyl, the person responsible for
conducting the blood methanol measurements in the NutraSweet-
funded, flawed study by Leon (1989) discussed earlier.

---------------

In July 1976, the FDA decides to investigate 15 key studies
submited by G.D. Searle in which the 1975 FDA Task Force
discovered problems. Three (3) of the studies were
investigator at the FDA by a 5-member Task Force headed by
FDA veteran Inspector, Jerome Bressler.

---------------

On August 4, 1976, G.D. Searle representatives met with the
FDA and convinced them to allow G.D. Searle to hire a
private agency, University Associated for Education in
Pathology (UAREP), and pay them $500,000 to "validate" the
other 12 studies (Gordon 1987)

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 (1984):

     "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. . . .
     
     "Meanwhile, an interview with Endicott indicates
     that Adrian Gross was right: the pathologists
     couldn't--and didn't--carry out a comprehensive
     review. . . . As former FDA Commissioner Alexander
     Schmidt put it in a recent interview, UAREP looked
     at the slides to determine whether they had been
     misrepresented, but didn't look at the conduct of
     the experiments in depth. The 1975 [FDA] task
     force investigation looked at the conduct of the
     experiments in depth, but did not look at the
     slides. . . . Endicott agreed . . . 'We could only
     look at what was there--the tissues.'

The findings of this investigation where released in the
Bessler Report in August 1977 (see below).


1977
----
Donald Rumsfeld, who was a former member of the U.S.
Congress and the Chief of Staff in the Gerald Ford
Administration, is hired as G.D. Searle's President.
Attorney James Turner alledged that G.D. Searle hired
Rumsfeld to handle the aspartame approval difficulties as a
"legal problem rather than a scientific problem." (Gordon
1987).

As layed out by Mary Nash Stoddard (Stoddard 1995), 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 Ford White House.

---------------

On January 10, 1977, FDA Chief Counsel Richard Merrill
recommends 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
(Congressional Record 1985b, page S10827):

     "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 conceailing 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 abyssmal as discussed
above. However, there were two studies where the violation
of the law were 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 from the
FDA and the 46-week toxicity study in the hamster where G.D.
Searle had taken blood from healthy animals at the 38th week
and claimed 1) that the blood tests were performed on
different animals -- ones that were dead at the 38th week --
and 2) that the tests had actually been performed at the
26th week.

---------------

On January 26, 1977, G.D. Searle's law firm Sidley & Austin
requests a meeting with U.S. Attorney Samuel Skinner before
a grand jury is convened (Gordon 1987, Mullarkey 1994b).

---------------

On March 8, 1977, in a confidential memo to aides, U.S.
Attorney Samuel Skinner states that he had begun preliminary
employment discussions with G.D. Searle's law firm Sidley &
Austin (Gordon 1987, Mullarkey 1994b).

---------------

On April 13, 1977, a U.S. Justice Department memo urges 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 monkey study and December 8, 1977
for the hamster study) (Mullarkey 1994b).

---------------

Samual Skinner withdraws from the G.D. Searle case and
Assistant U.S. Attorney William Conlon was then assigned to
the case (Stoddard 1995).

---------------

On July 1, 1977, U.S. Attorney Samuel Skinner leaves his job
to work for the G.D. Searle law firm Sidley & Austin. Thomas
Sullivan was appointed as Samuel Skinner's successor (Gordon
1987, Stoddard 1995).

---------------

Assistant U.S. Attorney William Conlon convenes a grand
jury, but lets the Statute of Limitations run out on the
aspartame charges (Gordon 1987). A year later, Conlon
accepts a job with the law firm representing G.D. Searle,
Sidley & Austin (Stoddard 1995).

---------------

Robert McConnell was the Director of G.D. Searle's
Department of Pathology and Toxicology which oversaw most of
the aspartame research. Mr. McConnell was named in Richard
Merrill's letter to U.S. Attorney Samuel Skinner. According
to McConnell's attorney, his client was awarded a $15,000
bonus and asked to take a 3-year sabbatical (for which he
received $60,000/year) because he was a "political
liability." (Gordon 1987)

---------------

Philip Brodsky, the Lead Investigator for the orginal FDA
Task Force looking into G.D. Searles studies retires. He
states that his reason for retiring was the disclosure of
the 1975 FDA Task Force findings before the U.S. Congress
(Sen Kennedy hearings in 1976) had become "politicized." As
Gregory Gordon put it in the UPI Investigative article:

     "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.'"

---------------

In August 1977, the Bressler Report is released. Some of the
findings from the three studies reviewed by the Bressler-led
FDA Task Force include (Mullarkey 1994b, Farber 1989, US Senate
1987, page 385):

a. 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.

b. The original pathology sheets and the pathology sheets
   submitted to the FDA showed differences for 30 animals.

c. One animal was reported alive at week 88, dead from week
   92 through week 104, alive at week 108, and finally dead
   at week 112.

d. An outbreak of an infectious disease was not reported to
   the FDA.

e. 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.

f. 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.

g. Fifteen fetuses from animals in one experiment were
   missing.

h. Sections from the animals were too thick for
   examination.

i. There was no documentation on the age or source of the
   test animals.

j. There was no protocol until one of the studies was well
   underway.

k. Animals were not permanently tagged to prevent mixups.

l. Some laboratory methods were changed during the study,
   but not documented.

A G.D. Searle pathologist referring to the DKP study was
quoted by investigators as saying (Graves 1984):

     "You should have seen things when this study was
     run -- there were five studies being run at one
     time -- things were a mess!"

The leader of the Task Force, Jerome Bressler, was quoted as
saying (Gordon 1987):

     "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 this
     product."

---------------

Immediately after the Bressler Report was released, H.R.
Roberts, Director of the FDA's Bureau of Foods creates a 5-
person task force to review the Bressler Report. (H.R.
Roberts would leave the FDA to become the a vice president of the
National Soft Drink Association in 1978.) FDA Toxicologist,
Jacqueline Verrett was appointed the Senior Scientist of the
Bureau of Foods Task Force.

On September 28, 1977, H.R. Roberts, Director of the FDA's
Bureau of Foods received a report from a Bureau of Foods
Task Force which claimed that G.D. Searle's studies they
reviewed appeared to be authentic (meaning that they were
actually conducted) (Mullarkey 1994b).

For each of the major discrpancies 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 Senior Scientist of the FDA Bureau of Foods Task Force,
Jacqueline Verrett had left the FDA when she openly
discussed the Task Force with UPI Investigative Reporter,
Gregory Gordon (Gordon 1987):

     "Jacqueline Verrett, the senior scientist on the
     review team, said members were barred from stating
     opinions about the research quality. 'It seemed
     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.'

In her testimony before the U.S. Senate, Dr. Verrett stated
the following (US Senate 1987, page 383-390):

     "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 precedures 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 definately did not objectively
     evaluate these studies, and I really think it
     should have been thrown out from day one.
     
     "We were looking at a lot of little details and
     easy parameters in this study, when the foundation
     of the study, the diet and all of these other
     things, were worthless. We were talking about the
     jockey when we should have been talking about the
     horse, that he had weak legs. It is built on a
     foundation of sand."


1978
----
On December 13, 1978, UAREP submits its results of their
analysis on 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) 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 (Graves 1984).

As it turns out, UAREP pathologists who examined the test
results were discovered to have withheld negative findings
from the FDA. In some cases, they completely missed
cancerous brain tumors when analyzing the slides. 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 (US Senate 1987, page 445-446). 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." (US Senate
1987, page 473-474)


1979
----
In March of 1979, the FDA concludes 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.

---------------

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):

     a. Whether the ingestion of aspartame either
        alone or together with glutamate poses a risk
        of contributing to mental retardation, brain
        damage, or undesireable effects on
        neuroendocrine regulatory systems.
     
     b. Whether the ingestion of aspartame may induce
        brain neoplasms (tumors) in the rat.
     
     c. 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 and G.D. Searle were allowed to nominate
scientists for the 3-person PBOI panel (Farber 1989).

It is important to note that the scope of the review was very
limited in light of all of the 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.

One of the PBOI members, Dr. Walle Nauta stated:

   "It was a shocking story we were told [about Searle's animal
    testing] but, there was no way we could go after it.  We
    had absolutely no way of knowing who was right.  We had to
    take the FDA's word." (Graves 1984)

---------------

In June of 1979, the acting FDA Commissioner, Sherwin
Gardner selects 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 on grounds of conflict of
interest and lack of qualifications. His objections were
overruled and the panelists who he objected to was assigned
to study the issue of aspartic acid toxicity (US Senate
1987, page 470) .


1980
----
The Public Board on Inquiry voted unanimously to reject the
of aspartame until studies on brain tumors could be done.

1981
----
On January 21, 1981, the day after Ronald Reagan takes
office as U.S. President, G.D. Searle reapplies for the
approval of aspartame. It was believed that Reagan would
certainly replace Jere Goyan, the FDA Comissioner. 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).

---------------

According to a former G.D. Searle salesperson, Patty Wood-
Allott, G.D. Searle president, Donald Rumsfeld told his
salesforce 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)

---------------

In March of 1981, a 5-member panel of scientists is
established bythe FDA Commissioner Jere Goyan to review the
issues raised by the PBOI (Mullarkey 1994a).

---------------

In April 1981, Arthur Hull Hayes, Jr. was appointed FDA
Commissioner by Ronald Reagan.

---------------

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 (Stoddard 1995).
In another study, Dubey said that key data appeared to have
been altered (Gordon 1987).

In his UPI Investigation, Gregory Gordon goes on to describe
the unusual events that followed (Gordon 1987):

     "[Douglas] Park said that [panel lawyer Joseph]
     Levitt hurried the panel to decide the issue.
     'They wanted to have the results yesterday,' he
     said. 'We really didn't have the time to do the in-
     depth review we wanted to do.'
     
     "Part said Levitt met frequently with Hayes and
     'was obviously getting the pressure to get a
     resolution and a decision made.'
    
 
     "With three of five scientists on the
     commissioner's team opposing approval, it was
     decided to bring in a toxicologist for his opinion
     on isolated issues [Barry N. Rosloff]. Goyan said
     if the decision were his, he never would have
     enlarged the team. While the panel did not vote,
     it ended up split 3-3.
     
     "Levitt, who normally would have been expected to
     draft an options paper spelling out scientific
     evidence on key issues, took an unusual tack. He
     circulated an approval recommendation and only
     backed of when Dubey, Park, and Condon  objected,
     team members said. Levitt said he was not directed
     to draft the approval memo, but did so as a
     'tactical' step to break the team's weeks-long
     impasse by forcing each scientist to state his
     views. 'It worked, didn't it?' said Levitt, who
     later was promoted to a post as an executive
     assistant to the FDA Commissioner."
     
---------------

On July 18, 1981 aspartame was approved for use dry foods by
FDA Commissioner Arthur Hull Hayes, Jr. overruling the
Public Board of Inquiry and ignoring the law which says that
a food additive should not be approved if tests are
inconclusive (Federal Register 1981, Stoddard 1995). In an
article in Common Cause Magazine, Florence Graves states
that two FDA offices said that Arthur Hull Hayes, Jr. wanted
to push aspartame approval through in order to signal
reforms of the Reagan Administration.


1982
-----
On October 1, 1982 an amendment was attached to the Orphan
Drug Act (an act which encourages the development of drugs
for rare diseases) which modified the U.S. Patent law
(Congressional Record 1982). The amendment extended the
patent on only one product -- aspartame --by 5 years, 10
months and 17 days (Gordon 1987). The amendment did not
mention aspartame or G.D. Searle by name and there was no
debate or discussion on the amendment.

The amendment was proposed by Senator Howell Heflin, brought
up for a vote by Senator Robert Byrd, and pushed through by
Representative Henry Waxman and Orrin Hatch. G.D. Searle
asked Senator Heflin to sponsor the amendment. Heflin
received $9,000 in campaign donations shortly after this
amendment was approved from G.D. Searle company executives
and their wives. Senator Byrd had received a $1,000 campaign
contribution from the CEO of G.D. Searle before the
amendment was proposed. Representative Waxman received a
$1,500 campaign contribution from the soft drink political
action committee including $500 before the amendment was
proposed. Senator Hatch received $2,500 from the soft drink
political action committee (Gordon 1987). Senator Hatch
repeatedly blocked hearings looking into the safety of
aspartame (Gordon 1987).

It could be argued that the amendment to extend G.D.
Searle's patent of aspartame rectified the lost marketing
time caused by the FDA investigations. However, it was G.D.
Searle's horrendous pre-approval studies which led to the
FDA investigations and the delays. Had they performed the
studies with any competance, aspartame could have been
approved quickly like any other FDA-approved food additive.
(Actually, had the studies been done right, it is likely
that aspartame would never been approved due to serious
adverse reactions.) In addition, the amendment was
applicable to one product and cannot be used similarly for
other products.

[snip]

                         References

Cloninger, M.R., R.E. Balwin 1970. "Aspartylphenylalanine
  methyl ester: a low calorie sweetener," Science, Volume
  170, page 81.

Congressional Record 1985a. "Saccharin Study and Labeling
  Act Amendments of 1985," Congressional Record, Volume
  131, No. 58, May 7, 1985, page S5489-S5519.

Congressional Record 1985b. "Aspartame Safety Act,"
  Congressional Record, Volume 131, No. 106, August 1,
  1985, page S10820-10847.

Farber, Steven A. 1989. "Aspartame and the Regulation of
  Food Additives: A Study of FDA Decision-Making and a
  Proposal for Change," Master of Science in Technology and
  Public Policy Thesis at Massachusetts Institute of
  Technology, Cambridge, MA 02139.

Federal Register 1973. Notice of Filing of Food Additive
  Petition, G.D.Searle & Company. Federal Register, Volume
  38, page 5,921.

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Mullarkey, Barbara 1994b. "How Safe Is Your Artificial
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US Senate 1975. U.S. Senate Joint Hearings before the
  Subcommittee on Health of the Committee on Labor and
  Public Welfare and the Subcommittee on Administrative
  Practice and Procedure of the Committee on the Judiciary,
  "Preclinical and Clinical Testing by the Pharmaceutical
  Industry, 1975, Part 1," No. Y4.L11/2:P49/2/975, CIS#
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US Senate 1976a. U.S. Senate Joint Hearings before the
  Subcommittee on Health of the Committee on Labor and
  Public Welfare and the Subcommittee on Administrative
  Practice and Procedure of the Committee on the Judiciary,
  "Preclinical and Clinical Testing by the Pharmaceutical
  Industry, 1976, Part 2," No. Y4.L11/2:P49/2/976/pt2, CIS#
  S541-82.

US Senate 1976b. U.S. Senate Joint Hearings before the
  Subcommittee on Health of the Committee on Labor and
  Public Welfare and the Subcommittee on Administrative
  Practice and Procedure of the Committee on the Judiciary,
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US Senate 1987. U.S. Senate Committee on Labor and Human
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