This is a copy of the front page showing time/date accepted with court case number of the $350 Million Plus Lawsuit Filed Against Nutrasweet Monsanto Aspartame Sweetener filed today, Wednesday, September 15th, 2004, U.S. Federal District Court, San Francisco, California
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Below is a complete copy of the lawsuit. Court Case # C 04 3872
Posted: 15 September 2004
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF CALIFORNIA
- Joe Bellon, individually; and as Private Attorney General; and, as a representative of a class of Plaintiffs,
- NutraSweet Company, a Delaware Corporation; and, Dr. Robert H. Moser, individually; and the American Diabetes Association; and Monsanto Company; and Does 1-50 inclusive.
COMPLAINT FOR DAMAGES; R.I.C.O.; and INJUNCTIVE RELIEF
COMES NOW, the above named Plaintiff, Joe Bellon, and for a cause of action against the above named Defendants claim and allege as follows:
PRAYER FOR RELIEF
- This action seeks redress for the Defendants' unlawful acts of knowingly and intentionally using the neurotoxic Aspartame as a sugar substitute in the manufacture of Equal, while knowing that exposure to Aspartame causes among other diseases/symptoms: abdominal pain, arthritis, asthma, brain cancer, breathing difficulties, burning eyes or throat, burning urination, chest pains, chronic cough, chronic fatigue, death, depression, diarrhea, headaches/migraines, hearing loss, heart palpitations, hives (urticaria), hypertension, impotency and sexual problems, memory loss, menstrual problems or changes, nausea or vomiting, slurring of speech, tremors, tinnitus, vertigo and/or vision loss. Further, Aspartame disease mimics symptoms or worsens the following diseases: Fibromyalgia, Arthritis, Multiple Sclerosis, Parkinson's Disease, Lupus, Diabetes and diabetic complications, Epilepsy, Alzheimer's Disease, birth defects, Chronic Fatigue Syndrome, Lymphoma, Lyme Disease, Attention Deficit Disorder (ADD), Panic Disorder, Depression and other psychological disorders.
- Despite scientific documentation of the above, Defendants have exposed the Plaintiff and other similarly situated consumers, without warning of the known medical and health hazards of Aspartame consumption. By these knowing and intentional acts of concealment and concomitant deception, each of these Defendants in the course of doing their business of marketing and selling NutraSweet, knowingly and intentionally exposed the targeted consumer to the toxic chemical Aspartame, known to the Defendants to cause the above noted medical conditions, among others.
- This action is about Defendants' intentional targeting of a segment of the general consuming public, including the Plaintiff herein, through advertising and marketing designed to encourage the purchase and consumption of NutraSweet/Equal, while knowing that these products are made of Aspartame, a neurotoxic chemical. Aspartame and NutraSweet naming conventions are interchangeable, as they describe the same product.
- Ultimately, this action is about falsity - about each Defendant's knowing and intentional acts of concealment and deception, whereby each Defendant, jointly and severally, committed said acts to the detriment of the Plaintiff and other similarly situated citizens.
IDENTIFICATION OF PARTIES
- The above named Plaintiff is now and at all relevant times hereto has been a resident of the City of Concord, County of Contra Costa and the State of California and is and has been a consumer of NutraSweet, Diet Coke and Diet Pepsi. All of which contain NutraSweet/Aspartame and, Plaintiff is similarly situated with consumers in the general public and is representative of a class of persons damaged by the actions/inactions of the Defendants herein as described below.
- The Defendant NutraSweet Company is and at all times herein mentioned was, a corporation organized under the laws of Delaware registered to do business in the United States of America with its principal place of business in Chicago, Illinois. NutraSweet sells NutraSweet/Equal in the state of California and worldwide. NutraSweet advertises its products extensively in California. NutraSweet's WEB site (which contains some of the false information at issue in this complaint) is accessible to California consumers including the Plaintiff herein. Among other businesses, NutraSweet was engaged in the advertising of and for, purchase and sale of Aspartame and Aspartame infused products, construction and ownership of facilities used in the additive process infusing Aspartame into foods, beverages and/or drug related products for the consumption of the general public in various countries, including the United States.
- Defendant Robert H. Moser is the Vice President of medical affairs and former Chief Executive Officer for the NutraSweet Company and is responsible for informing the general public of the qualities of Aspartame for the company and its subsidiaries. In this capacity he is intimately familiar with the studies related to Aspartame. In said capacity Defendant Moser has misrepresented medical facts to the general public, while knowing said facts to be untrue and with the intent to increase the sales revenue for the NutraSweet enterprise. Defendant Moser has made misrepresentations that free methyl alcohol is found in vegetables, meat, dairy products and grain, all the while knowing that methyl alcohol does not occur naturally and is a poison. Dr. Moser also has represented that formaldehyde is not hazardous to the human body. Such statements and representations on behalf of NutraSweet are directly and proximately related to the actions of the company in the use and sale of Aspartame as an additive in the following products:
-- BAYER CORPORATION, maker of One A Day Kids, Scooby-Doo Multivitamin Plus Calcium and Flintstones Complete vitamins;
-- ConAgra Foods, maker of Healthy Choice foods;
-- DANNON COMPANY, maker of Sugar Free Yogurt;
-- The J. M. Smucker Company, maker of Sugar Free Jams and Jellies
-- Kellogg Company, parent of Murray Biscuit Company, maker of Murray Sugar Free Cookies
-- Wm. Wrigley Jr. Company, maker of Sugar Free and Sugarless Gum;
-- Wyeth, maker of Centrum Kids Rugrats vitamins;
-- PepsiCo, maker of Diet Pepsi;
-- Conopco, parent of Slim-Fast;
-- Altria Group, parent of Kraft Foods, maker of Crystal Light, Sugar Free Jell-O, and Sugar Free French Vanilla Café', Café' Vienna and Suisse Mocha
- Defendant American Diabetes Association is an organization organized under the laws of the state of Virginia . According to the ADA's website, the mission of the Association is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To fulfill this mission, the American Diabetes Association funds research, publishes scientific findings, provides information and other services to people with diabetes, their families, health professionals and the public. The Association is also actively involved in advocating for scientific research and for the rights of people with diabetes. Within the ADA's website, it states: "Can I use low calorie sweeteners? Low calorie sweeteners are safe for everyone except people with phenylketonuria, who should not use Aspartame. Calorie-free sweeteners like Aspartame, saccharin, sucralose and acesulfame-K won't increase your blood glucose level."
- The website also contains this misinformation:
Aspartame metabolism in normal adults, phenylketonuric heterozygotes, and diabetic subjects
LJ Filer and LD Stegink
Department of Pediatrics, College of Medicine, University of Iowa, Iowa City 52242.
This study reviews clinical studies testing the effects of various doses of Aspartame on blood levels of phenylalanine, aspartate, and methanol in normal subjects and known phenylketonuric heterozygotes. The effect of Aspartame on the phenylalanine-to-large neutral amino acid ratio under various feeding situations is shown. The clinical studies of Aspartame in diabetic subjects are limited to observations of its effects on blood levels of glucose, lipids, insulin, and glucagon. These studies clearly demonstrate the safety of this high-intensity sweetener for use by humans.
- In exchange for promoting NutraSweet/Aspartame as a safe and healthy alternative to sugar, ADA receives grant money and other funding from NutraSweet Company or its agents.
- Monsanto Company, whose primary offices are located in St Louis, Missouri, manufactured and sold the product Aspartame and was the owner the NutraSweet Company and is the predecessor in interest to the current owners of the NutraSweet Company. While owning NutraSweet, Monsanto engaged in the same misinformation and fraudulent activity as the present NutraSweet Company. During its ownership of NutraSweet, Monsanto Company had significant contacts in the state of California and sold its products to California consumers.
JURISDICTION AND VENUE
- The actions alleged herein occurred within the state of California and elsewhere. The Defendants and each of them have minimum contacts with the state of California. The parties hereto diverse and the amount in controversy is in excess of $75,000.00. Jurisdiction is also conferred upon this court by way of the subject matter of this action 28 U.S.C. 1331 and 1332, and 18 U.S.C. 1964.
- In or about and between 1974 and 2004, both dates being approximate and inclusive, within the State of California and elsewhere, Defendants, and others, in a course of conduct of promoting, selling and manufacturing NutraSweet product which is the product name for the sugar substitute and artificial sweetener Aspartame, did willfully and unlawfully use and employ manipulative and deceptive devices and contrivances and directly and indirectly (I) employ devices, schemes and artifices to defraud; (ii) make untrue statements of material facts and omit to state facts necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading; and (iii) engage in acts, practices, and courses of conduct which would and did operate as a fraud and deceit upon members of the general public, plaintiff included, in connection with purchases and sales of the additive Aspartame and by the use of the instruments of communication in interstate commerce and the mails all in the furtherance of their respective scheme or enterprise.
- In or about and between 1974 and 2004, both dates being approximate and inclusive, within the State of California and elsewhere, Defendants , and others, did knowingly and intentionally conspire (1) to willfully and unlawfully use and employ manipulative and deceptive contrivances and directly and indirectly (I) to employ devices, schemes and artifices to defraud; (ii) to make untrue statements of material fact and omit to state facts necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading; and (iii) to engage in acts, practices, and courses of conduct which would and did operate as a fraud and deceit upon members of the investing public, in connection with the manufacture, approval, sales, purchase and consumption of Aspartame products and by use of the instruments of communication in interstate commerce and the mails, and (2) to devise a scheme and artifice to defraud government entities, both federal and state, and other members of the public, and to obtain money and property by means of materially false and fraudulent pretenses, representations and promises, and, for the purpose of executing such scheme and artifice would transmit and cause to be transmitted by means of wire communications in interstate commerce writings, signs, pictures and sounds.
- The true names and capacities of the Defendants sued herein as Does 1 through 50, inclusive, are unknown to Plaintiff at this time and Plaintiff sues the said Defendants by such fictitious names. Plaintiff will ask leave of the court to amend this complaint to show their true names and capacities when the same have been ascertained. Each of the fictitiously named Defendants is responsible in some manner for the conduct alleged herein and may include, but are not limited to, the corporate officers of Defendant Corporations and Defendant Entities, both in their official and private capacities, and research and development entities that knew or should have known of the health hazards of Aspartame, but - for reasons yet unknown to Plaintiff - participated in the introduction of this neurotoxin into the stream of commerce.
STATEMENT OF FACTS AS TO DEFENDANTS
- Defendant NutraSweet manufactures and distributes for sale NutraSweet/Aspartame.
- The sugar substitute NutraSweet/Aspartame, the use of which is the subject of this action.
- Defendants market NutraSweet through several media including, but not limited to: print, audio, video and internet (being a combination of all three media).
- Defendants through print media have made representations about NutraSweet/Aspartame to the consumer that it is safe and healthy.
- Defendants through the internet have represented to the consuming public that NutraSweet is safe and healthy.
- Defendants knew or should have known that the use of the chemical, Aspartame, in human food products was injurious to the health of the consuming public.
- Despite said knowledge, Defendants failed and refused to inform the consuming public of the known health hazards associated with the consumption of the chemical, Aspartame.
- Defendants continue to sell and market NutraSweet to the consuming public to the detriment and harm to the consuming public without reservation or warning about the known health hazards associated with the consumption of Aspartame via NutraSweet.
- Defendants regularly advertise via various media outlets, internet, etc. and recommend their products to specific portions of the general population, including, but not limited to: diabetics and obese persons, who are considered disabled under Medicare/Medicaid guidelines; the dieting public, and; people wishing to lower their intake of sugar in their diets in general.
A. STATEMENT OF FACTS
History of Aspartame
The Year 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). Working on an ulcer drug, a group was formed that included, 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, page 3).
The Year 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 spilled onto the outside of the flask. Some of the powder landed on 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).
The Year 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 aftertaste."
The Year 1970:
- The discovery of Aspartame is reported in the well-known publication, science (Cloninger 1970).
- 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 grand mal seizures. The actual results were hidden from the FDA when G.D. Searle submitted its initial applications (Stoddard 1995a, page 6; Merrill 1977; Graves 1984, page S5506 of Congressional Record 1985a; Gross 1976b, page 333 of US Senate 1976b).
- G.D. Searle denied knowledge of or involvement with the initiation, design or performance of the study. Yet, the 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 reported the animals were unavailable for purchase for autopsy after the termination of the study.
- 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).
- An internal G.D. Searle memo laid out the strategy for getting Aspartame approved (Helling 1970):
At this meeting [with FDA officials], the basic philosophy of our approach to food and drugs should be to try to get them to say "Yes," to rank the things that we are going to ask for so we are putting first those questions we would like to get a "yes" to, even if we have to throw some in that have no significance to us, other than putting them in a yes saying habit. We must create affirmative atmosphere in our dealing with them. It would help if we can get them or get their people involved to do us any such favors. This would also help bring them into subconscious spirit of participation.
- The FDA banned 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 1995a, page 7).
The Year 1971:
- Ann Reynolds, a researcher who was hired by G.D. Searle and who had done research for the Glutamate (MSG) Association, confirmed Aspartame's neurotoxicity in infant mice (Reynolds 1971).
- Dr. John W. Olney informed 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 (Olney 1970, Gordon 1987, page 493 of US Senate 1987).
The Year 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 (Gross 1975, page 35; Schmidt 1976b, page 6).
The Year 1973:
- 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). (See: Federal Register 1973. Notice of Filing of Food Additive Petition, G.D.Searle & Company. Federal Register, Volume 38, page 5,921.)
- On March 21, 1973 the MBR report was submitted to G.D. Searle.
Background of the MBR Report
- 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, Aspartame. One study was conducted at G.D. Searle and one at Hazelton Laboratories. In March 1972, the rats for autopsied and the pathology slides were analyzed. For confirmation of the results, G.D. Searle sent the slides to Biological Research, Ltd. where board certified pathologist, Dr. Jacqueline Mauro examined the data. She discovered that the drug appeared to induce tumors in the liver, testes, and thyroid of the rats. The report submitted to G.D. Searle by Dr. Mauro was known as the MBR Report.
- These statistically significant findings were confirmed by G.D. Searle's Mathematics-Statistics Department. Instead of submitting these alarming findings to the FDA, G.D. Searle contracted with another pathologist, Dr. Donald A. Willigan. He was given 1,000 slides to examine. The Willigan Report was more to G.D. Searle's liking because it revealed a statistically significant increase in thyroid and testes tumors, but not in liver tumors. Liver tumors are of much more concern to the FDA. The Willigan Report was immediately submitted to the FDA. G.D. Searle did not disclose the MBR Report to the FDA until August 18, 1975, 27 months after it had been given to G.D. Searle (Schmidt 1976b, page 14, Merrill 1977, page S10828-S10831).
- At first, G.D. Searle claimed that they did not submit the MBR Report to the FDA because of an "oversight." Later, they claimed that Dr. Mauro's MBR report was not submitted because they did not like the terminology Dr. Mauro used in evaluating the thyroid slides. They claimed that her inaccurate terminology in this case showed that Dr. Mauro was unreliable as a pathologist. Yet, G.D. Searle never notified Dr. Mauro of any questions and on June 1, 1973, they wrote to MBR and stated that the report "looks just fine" (Merrill 1977).
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 seemed unlikely...." (Mullarkey 1992, page 15)
- In an FDA memorandum dated September 12, 1973, Martha M. Freeman, M.D. of the FDA Division of Metabolic and Endocrine Drug Products addressed the adequacy of the information submitted by G.D. Searle in their petition to approve Aspartame (Freeman 1973):
"Although it was stated that studies were also performed with diketopiperazine [DKP] an impurity which results from acid hydrolysis of Aspartame, no data are provided on this product."
Commenting on one particular single-dose study, Dr. Freeman said:
"It is not feasible to extrapolate results of such single dose testing to the likely condition of use of Aspartame as an artificial sweetener."
- It is important to note that Dr. Freeman pointed out the inadequacy of single-dose tests of Aspartame as early as 1973. 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 bioavailability of capsule vs. food-additive administration."
Dr. Freeman concludes:
- 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."
- "The information submitted for our review is inadequate to permit a scientific evaluation of clinical safety."
- Dr. Freeman 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, page S5498 of 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." Ajinomoto is the inventor and main producer of the food additive MSG.
The Year 1974:
- 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:
"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 product...." (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 1995a, page 7).
- 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, Federal Register 1974). 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 this time it was not approved for baking goods, cooking, or carbonated beverages.
- 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, page S5498 of Congressional Record 1985a; Federal Register 1975, Olney 1987, page 3).
- G.D. Searle's responses to queries about the testing of their drug Flagyl, serious and unexpected side effects 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 testing of Aspartame and pharmaceuticals (Graves 1984, page S5498 of Congressional Record 1985a).
The Year 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 Laboratories, were the responsibility of the Pathology-Toxicology Department at G.D. Searle. (Gross 1987a, page 430 of US Senate 1987). The special Task Force was headed by Philip Brodsky, FDA's Lead Investigator and assisted by FDA Toxicologist, Dr. Adrian Gross.
- The Task Force was especially interested in "pivotal" tests as described in an article from Common Cause Magazine by Florence Graves (Graves 1984, page S5499 of
Congressional Record 1985a):
"Before the task force had completed its investigation in 1976, Searle had submitted the vast majority of the more than 100 tests it ultimately gave the FDA in an effort to get Aspartame approved. These included all tests 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." (Searle 1975)
- 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).
- 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, page 286, Mullarkey 1994b, page 5-6).
- 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 (Mullarkey 1994b, page 5-6; Federal Register 1975). The evidence of the Aspartame pivotal studies was 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).
The Year 1976:
- 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).
- In a preliminary statement before the US Senate regarding the breadth of the investigation, FDA Toxicologist and Task Force team member Dr. Adrian Gross stated: (Gross 1987a, page 1-2):
"Practices that were noted in connection with any given such study were quite likely to have been noted also for other studies that were audited, and this was a situation which was in no way unexpected: after all, the set of all such studies executed by that firm from about 1968 to the mid-1970's were conducted in essentially the same facilities, by virtually the same technicians, professional workers and supervisors, and the nature of such studies does not differ much whether a food additive or a drug product is being tested for safety in laboratory animals. It is in this sense, therefore, that the overall conclusion summarized at the beginning of the Searle Task Force Report have relevance to all the studies audited in 1975 (whether they had references to Aspartame or to any of the six drug products of Searle's) and, by extension, to the totality of experimental studies carried out by that firm around that time -- 1968 to 1975."
- A few of the conclusions of the FDA Task Force (Gross 1987a, page 2-3):
"At the heart of FDA's regulatory process is its ability to rely upon the integrity of the basic safety data submitted by sponsors of regulated products. Our investigation clearly demonstrates that, in the (case of the) GD Searle Company, we have no basis for such reliance now."
"We have noted that Searle has not submitted all the facts of experiments to FDA, retaining unto itself the unpermitted option of filtering, interpreting, and not submitting information which we would consider material to the safety evaluation of the product . . . Finally, we have found instances of irrelevant or unproductive animal research where experiments have been poorly conceived, carelessly executed, or inaccurately analyzed or reported."
"Some of our findings suggest an attitude of disregard for FDA's mission of protection of the public health by selectively reporting the results of studies in a manner which allay the concerns of questions of an FDA reviewer."
"Unreliability in Searle's animal research does not imply, however, that its animal studies have provided no useful information on the safety of its products. Poorly controlled experiments containing random errors blur the differences between treated and control animals and increase the difficulty of discriminating between the two populations to detect a product induced effect. A positive finding of toxicity in the test animals in a poorly controlled study provides a reasonable lower bound on the true toxicity of the substance. The agency must be free to conclude that the results from such a study, while admittedly imprecise as to incidence or severity of the untoward effect, cannot be overlooked in arriving at a decision concerning the toxic potential of the product."
- A few of the relevant findings summarized from various documents describing the FDA Task Force Report:
a. "Excising masses (tumors) from live animals, in some cases without histologic examination of the masses, in others without reporting them to the FDA." (Schmidt 1976c, page 4 of US Senate 1976b) Searle's representatives, when caught and questioned about these actions, stated that "these masses were in the head and neck areas and prevented the animals from feeding." (Buzzard 1976a)
"Failure to report to the FDA all internal tumors present in the experimental rats, e.g., polyps in the uterus, ovary neoplasms as well as other lesions." (Gross 1987a, page 8).
b. 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)
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, page 496 of US Senate 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." (Schmidt 1976c, page 5 of US Senate 1976b)
e. 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)
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." (Schmidt 1976c, page 4 of US Senate 1976b)
g. 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)
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." (Gross 1985, 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 1995a, page 9; Graves 1984, page S5500 of Congressional Record 1985a)
j. "In each study investigated, poor practices, inaccuracies, and discrepancies were noted in the antemortem phases which could compromise the study." (Gross 1985, page S10836 of Congressional Record 1985b)
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." (Schmidt 1976c, page 4-5 of US Senate 1976b)
l. Animals were not removed from the room during the twice per month exterminator spraying's. (Gross 1985, page S10836 of Congressional Record 1985b)
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." (Gross 1985, page S10836 of Congressional Record 1985b)
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. (Gross 1985, page S10837 of Congressional Record 1985b)
o. "Contrary to protocol, slides were not prepared of this [unusual lesions from the Aspartame (DKP) study) tissue for microscopic examination . . . ." (Gross 1985, page S10837 of Congressional Record 1985b)
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." (Gross 1985, page S10838 of Congressional Record 1985b) (The figures of 26 and 38 seem to be reversed when referred to later - Page 21, 2nd paragraph)
"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)
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, page 109)
r. [There were] "clerical or arithmetic errors which resulted in reports of fewer tumors." (Schmidt 1976c, page 27 of US Senate 1976b)
s. [G.D. Searle] "delay the reporting of alarming findings." (Schmidt 1976c, page 27 of US Senate 1976b)
- FDA Toxicologist and Task Force member, Dr. Adrian Gross stated (Wilson 1985):
"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, page S5499 of Congressional Record 1985a).
- 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 (Gross 1985, page S10838 of Congressional Record 1985b):
"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 (Graves 1984, page S5498 of Congressional Record 1985a):"[All tests were] scientifically irresponsible [and] disgraceful. I'm just shocked 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 (Kennedy 1976):"The extensive nature of the almost unbelievable range of abuses discovered by the FDA on several major Searle products is profoundly disturbing."
- In January, 1976, G.D. Searle defended their results by claiming (Searle 1976a, page 5-6):"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., which invalidates entire experiments and causes what they claim to be 4 million observations and calculations per study (average) to become irrelevant.
- Only the key Aspartame studies were looked at. It is almost a certainty that the non-key Aspartame studies were equally flawed. Therefore, this would invalidate the "hundreds of millions" of observations and calculations made during these studies.
- The difference between a study showing no statistical difference and a significant statistical difference is often only a few observations or calculations. Therefore, had the myriad of other serious experimental errors not occurred (as detailed above), the observation and calculation mistakes in each experiment investigated would, by themselves, invalidate most of the key studies.
- It is highly unlikely that the FDA Investigative teams found all of the problems with G.D. Searle's studies. G.D. Searle seemed so intent on covering up their misconduct, that it is quite likely that they were able to hide many of the problems from the FDA.
- A series of poorly conceived, flawed studies funded by G.D. Searle were published in Volume 2 (1976) of the Journal of Toxicology and Environmental Health. An Associate Editor of this scientific journal was Robert G. McConnell, the Director of G.D. Searle's Department of Pathology and Toxicology (the department responsible for monitoring the quality of G.D. Searle's pre-approval tests investigated by the 1975 FDA Task Force). Mr. McConnell's story continues later in 1977. Another G.D. Searle employee, Carl R. Mackerer was an editor of the journal. Another editor of the journal was Thomas R. Tephly, the person responsible for conducting a series of badly flawed blood methanol and formate measurements in NutraSweet-funded studies over the last 15 years.
- In July 1976, the FDA decided to investigate 15 key Aspartame studies submitted by G.D. Searle in which the 1975 FDA Task Force discovered problems. Three (3) of the studies were investigated at the FDA (E5, E77/78, E89) by a 5-member Task Force headed by FDA veteran Inspector, Jerome Bressler (Graves 1984, page S5499 of Congressional Record 1985a; Gordon 1987, page 497 of US Senate 1987; Farber 1989, page 110).
- 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 page 498 of US Senate 1987).
- According to 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, page S5500 of Congressional Record 1985a):
"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 involve 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 Bressler Report in August 1977 (see below).
The Year 1977:
- 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." (Gordon 1987, page 497 of US Senate 1987).
- As laid out by Mary Nash Stoddard (Stoddard 1995a, page 11), 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 connected 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 at the time was on the Board of Directors of the Chicago Tribune which wrote a glowing article about the NutraSweet Company (Millman 1995, Mullarkey 1995).
- 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 (Merril 1977, page S10827 of Congressional Record 1985b):"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, in 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, requests a meeting with U.S. Attorney Samuel Skinner, before a grand jury is convened (Gordon 1987 page 497 of US Senate 1987, Mullarkey 1994b, page 6-7). One representative of Sidley & Austin at that meeting was Newton Minow who was at the time on the Board of Directors at the Chicago Tribune (Gordon 1987, page 497 of US Senate 1987; Mullarkey 1995).
- 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 (Gordon 1987, page 497 of US Senate 1987; Mullarkey 1994b, page 7).
- 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) (Mullarkey 1994b, page 7).
- Samuel Skinner withdrew from the G.D. Searle case and Assistant U.S. Attorney William Conlon was then assigned to the Grand Jury investigation (Gordon 1987, page 497 of US Senate 1987).
- On July 1, 1977, U.S. Attorney Samuel Skinner left his job to work for the G.D. Searle law firm Sidley & Austin. Thomas Sullivan was appointed as Samuel Skinner's successor (Gordon 1987, page 497 of US Senate 1987).
- Assistant U.S. Attorney William Conlon convened a grand jury, but he let the Statute of Limitations run out on the Aspartame charges (Gordon 1987, page 497 of US Senate 1987). Fifteen months later, Conlon accepted a job with the law firm representing G.D. Searle, Sidley & Austin (Gordon 1987, page 497 of US Senate 1987).
- 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, page 496 of US Senate 1987)
- Philip Brodsky, the Lead Investigator for the original FDA Task Force looking into G.D. Searle's studies retired. He stated 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 (Gordon
1987, page 496 of US Senate 1987):
"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 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 (Mullarkey 1994b, page 11, 48; Farber 1989, page 110-
112; Verrett 1987, page 385 of US Senate 1987):
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 was 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 mix-ups.
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, page S5500 of Congressional Record 1985a):
"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, page 497 of US Senate 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 created a 5- person task force to review the Bressler Report. The review was done by a team at the Center for Food Safety and Applied Nutrition (CFSAN report). H.R. Roberts would leave the FDA to become 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 the G.D. Searle's studies they reviewed appeared to be authentic (meaning that they were actually conducted) (Mullarkey 1994b, page 8).
- For each of the major discrepancies found by the Bressler-led Task Force-those listed above and many others-there was a comment in the FDA Bureau of Foods Report minimizing the problem. It seemed that no matter how serious the mistakes were, the FDA Bureau of Foods was determined to accept the studies by G.D. Searle.
- The experimental errors as described above were so bad that it proved difficult to minimize all of the major errors in these key studies. In some cases, the best that the CFSAN could do was to say that "The Task Force could find no evidence that this was a deliberate attempt to influence the study." or "It could not be determined if the results would have been altered...." (Farber 1989, page 111, GAO 1987, Appendix IV).
- 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, page 497 of US Senate 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 (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 was done, based on what I have read in the GAO report that I have looked at and so forth. They definitely did not objectively evaluate these studies, and I really think it should have been thrown out from day one.
"We were looking at a lot of little details and easy parameters in this study, when the foundation of the study, the diet and all of these other things, were worthless. We were talking about the jockey when we should have been talking about the horse, that he had weak legs. It is built on a foundation of sand."
- The FDA general counsel wrote a letter to Consumer Attorney, James Turner, Esq. responding to Mr. Turner's concern about the quality and validity of G.D. Searle's experiments. The FDA stated, "The Public Board of Inquiry on Aspartame should provide a vehicle for definitive resolution, at least for those studies about which you are most concerned." (Graves 1984, page S5498 of Congressional Record 1985a). 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.
The Year 1978:
- 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 (Graves 1984, page S5500 of Congressional Record 1985a).
- As it turns out, UAREP pathologists who examined the test results were discovered to have missed and withheld negative findings from the FDA (Gross 1987b, page 2-5). 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 (Gross 1987b, page 3-4).
The Year 1979:
- In March of 1979, the FDA somehow concluded that G.D. Searle's Aspartame studies could be accepted. They decided 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). (See: Federal Register 1979. "Ruling on Objections and Notice of Hearing Before a Public Board of Inquiry; Aspartame," Federal Register, Volume 44, page 31,717.)
- 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 undesirable 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, 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 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 non-Aspartame related articles in collaboration with G.D. Searle scientists (Brannigan 1983, page 196). In addition, Dr. Olney stated that the question of aspartic acid's neurotoxicity should be looked at by a neuropathologist and that Dr. Young was unqualified since his field was Nutrition and Metabolism. Dr. Olney's objections were overruled by acting FDA Commissioner Sherwin Gardner and the panelists who he objected to was assigned to study the issue of aspartic acid toxicity.
- One of the PBOI members, Dr. Walle Nauta stated (Graves 1984, page S5498 of Congressional Record 1985a):
"It was a shocking story we were told [about Searle's animal testing] but, there was no way we could go after it. We had absolutely no way of knowing who was right. We had to take the FDA's word."
- Dr. Nauta stated that he would have "definitely" 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 Year 1980:
- The Public Board Of Inquiry voted unanimously to reject the use of Aspartame until additional studies on Aspartame's potential to cause brain tumors could be done. The PBOI was particularly concerned about experiment E33/34 where 320 rats received Aspartame and a much higher percentage of animals in the Aspartame group developed tumors than in the control group (Brannigan 1983, page 196). In addition, the PBOI was concerned about experiment E70 where 80 rats received Aspartame. Both the Aspartame group and the control group had an unusually high number of tumors, leading one to suspect that both groups were actually given Aspartame (Federal Register 1981).
- The PBOI did not believe that aspartic acid presented a neurotoxic hazard. Yet, Dr. Olney pointed out that (Olney 1987, page 3):
"[Dr. Young had a] lack of qualification" and that he "based his decision on a consideration of [aspartic acid] alone without regard to the real issue, i.e., is it safe to add [aspartic acid] to the large amounts of [glutamic acid/MSG] that are already adulterating the food 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.
The Year 1981:
- On January 21, 1981, the day after Ronald Reagan took office as U.S. President, G.D. Searle reapplied for the approval of Aspartame. G.D. Searle submitted several new studies along with their application. It was believed that Reagan would certainly replace Jere Goyan, the FDA Commissioner. G.D. Searle president, Donald Rumsfeld's connections to the Republican Party were also thought to play a part in Searle's decision to reapply for Aspartame's approval on the day after Ronald Reagan was inaugurated (Gordon 1987, page 499 of US Senate 1987).
- According to a former G.D. Searle salesperson, Patty Wood-Allott, G.D. Searle president, Donald Rumsfeld told his 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, page 499 of US Senate 1987)
- In March of 1981, a 5-member panel of scientists was established by the FDA Commissioner Jere Goyan to review the issues raised by the PBOI (Gordon 1987, page 498 of US Senate 1987; Mullarkey 1994b, page 8).
- 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 Senate 1987):
"[Douglas] Park said that [panel lawyer Joseph] Levitt hurried the panel to decide the issue. 'They wanted to have the results yesterday,' he said. 'We really didn't have the time to do the in-depth review we wanted to do.'
"Park said Levitt met frequently with Hayes and 'was obviously getting the pressure to get a resolution and a decision made.'
"With three of five scientists on the commissioner's team opposing approval, it was decided to bring in a toxicologist for his opinion on isolated issues [Barry N. Rosloff]. Goyan said if the decision were his, he never would have enlarged the team. While the panel did not vote, it ended up split 3-3.
"Levitt, who normally would have been expected to draft an options paper spelling out scientific evidence on key issues, took an unusual tack. He circulated an approval recommendation and only backed off when Dubey, Park, and Condon objected, team members said. Levitt said he was not directed to draft the approval memo, but did so as a 'tactical' step to break the team's weeks-long impasse by forcing each scientist to state his views. 'It worked, didn't it?' said Levitt, who later was promoted to a post as an executive assistant to the FDA Commissioner."
- On July 18, 1981 Aspartame was approved for use in dry foods by FDA Commissioner Arthur Hull Hayes, Jr. overruling the Public Board of Inquiry and ignoring the law, Section 409c(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 (Federal Register 1981, Farber 1989, page 38). In an article in Common Cause Magazine, Florence Graves states that two FDA officials said Arthur Hull Hayes, Jr. wanted to push Aspartame approval through in order to signal reforms of the Reagan Administration. The "reasoning" behind the FDA Commissioner's decision will be discussed in a later section (Graves 1984, page S5497 of Congressional Record 1985a).
The Year 1982:
- On October 15, 1982, G.D. Searle petitioned the FDA for approval to use Aspartame in soft drinks and children's vitamins (Gordon 1987, page 499 of US Senate 1987; Farber 1989, page 38)
- 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, page 504 of US Senate 1987). The amendment did not mention Aspartame or G.D. Searle by name and there was no debate or discussion on the amendment. (See: Congressional Record 1982. "Orphan Drug Act," Congressional Record, December 14, 1982, page 30445.)
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 from G.D. Searle company executives and their wives, shortly after this amendment was approved. Senator Byrd 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 prior to his re-election and $1,000 each from Daniel Searle, Wesley Dixon (Daniel Searle's brother-in-law), and William Searle (Gordon 1987, page 506 of US Senate 1987). Senator Hatch repeatedly blocked hearings looking into the safety of Aspartame (Gordon 1987, page 506 of US Senate 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 competence, 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 have been approved due to serious adverse reactions.) In addition, the amendment was applicable to one product and cannot be used similarly for other products.
- Between 1979 and 1982, four FDA officials who took part in the Aspartame approval process went through the FDA revolving door and took jobs in industries that are closely linked with the NutraSweet issue (Gordon 1987, page 498 of US Senate 1987):
The Year 1983:
- Mike Taylor was an FDA lawyer who represented the FDA Bureau of Foods at the PBOI and was part of the team that prevented the quality and validity of G.D. Searle's studies from being considered (Gordon 1987, page 498 of US Senate 1987).
- 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. Gardner claims that he did not discuss Aspartame in his 4 meetings with the FDA within a year of leaving that agency, or his 20 meetings with the FDA between 1980 and 1986, the organization he worked for does deal directly with Aspartame products. It is unlikely that he would have been rewarded with the job had he called for another delay in approval and proposed that safety tests be conducted independently in order to protect the public.
- Stuart Pape was the Health and Human Services (HHS) Chief Counsel for Foods from October 1976 to March 1979. He served as special assistant to the FDA Commissioner from March 1979 to December 1979. He participated in meetings and discussions on Aspartame as well as representing the FDA at the PBOI.
In December 1979, Mr. Pape was given a job by the law firm of Patton, Boggs, and Blow. This law firm provided counsel to the National Soft Drink 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 beverages (GAO 1986).
- Acting FDA Commissioner, Mark Novitch approved Aspartame for use in carbonated beverages and carbonated beverage syrup bases (Federal Register 1983). FDA Commissioner, Arthur Hull Hayes was out of town the day the approval was signed, but he worked closely with Mark Novitch on this issue (Gordon 1987, page 499 of US Senate 1987). Ignoring the FDA's own safety standards, they more than doubled the Acceptable Daily Intake (ADI) of Aspartame from 20 mg/kg to 50 mg/kg (Metzenbaum 1985).
- Shortly after the FDA approval for Aspartame in carbonated beverages, FDA Commissioner, Arthur Hull Hayes left the FDA under charges of improprieties and took a position as the Dean of New York Medical Collage. Interesting to note, he also was hired as an a consultant ($1,000 per day) with G.D. Searle's public relations firm, Burston Marsteller (Gordon 1987, page 499 of US Senate 1987).
- On July 8, 1983, Dr. Woodrow Monte, Director of the Science and Nutrition Laboratory at Arizona State University filed a petition objecting to the approval of Aspartame based on possible serious adverse effects from the chronic intake of Aspartame. Dr. Monte was especially concerned about the chronic intake of methanol (Federal Register 1984). Dr. Monte also filed a petition with the Arizona Department of Health Services to ban Aspartame. On July 8, 1983, James Turner, Esq. filed a petition with the FDA on behalf of himself and Community Nutrition Institute objecting to the approval of Aspartame (Federal Register 1984).
- Dr. Woodrow Monte, at the suggestion of his lawyer, invested $2,000 in G.D. Searle stock options in order to raise money for his costly legal battles against Aspartame. He ended up losing $1,224. His purchasing of the "put options" caused some controversy. Dr. Monte was later accused of conflict-of- interest by G.D. Searle. Dr. Monte's lawyer had told him that he "didn't think there was anything wrong" with purchasing the options - a move Dr. Monte later called a mistake. (Gordon 1987, page 508 of US Senate 1987)
- On November 23, 1983, the FDA denied a request to put the approval on hold "because public interest did not require it." (Federal Register 1984).
The Year 1984:
- On February 17, 1984, the FDA denied Dr. Woodrow Monte and James Turner the opportunity to hold a safety hearing on questions raised in their petition (Federal Register 1984).
- G.D. Searle sent a number of lobbyists to the State of Arizona, including: Andrew Herwitz, Arizona Governor Babbitt's former Chief of Staff; Charles Pine, a prominent Arizona lobbyist; Roger Thies, a G.D. Searle lawyer, and; David West, a G.D. Searle official (Gordon 1987, page 507 of US Senate 1987; Stoddard 1995a, page 17).
- The State of Arizona DHS completed studies showing that Aspartame in carbonated beverages can break down into free methanol (among other things) in 99°F temperatures. The amount of methanol which broke down concerned the DHS enough that a ban of Aspartame was discussed (Gordon 1987, page 507 of US Senate 1987).
- Between August 23, 1984 and September 21, 1984, G.D. Searle officials contributed to the campaign of Arizona House Majority Leader Burton Barr. The Committee to Re-elect Barr then gave campaign contributions to a number of state representatives (Don Aldridge, Karen Miills, Jan Breuer) who all eventually voted in G.D. Searle's favor (Gordon 1987, page 507 of US Senate 1987).
- Dr. Woodrow Monte's petition for a hearing regarding banning Aspartame in Arizona was rejected (Gordon 1987, page 507 of US Senate 1987).
- 6,900,000 pounds of Aspartame were consumed in the U.S. in 1984 (USDA 1988).
The Year 1985:
- Dr. Richard Wurtman of MIT is quoted as saying that Dr. Gerald Gaull, a G.D. Searle Vice President, came to his laboratory and threatened to veto his funding from the International Life Sciences Institute (ILSI) after Wurtman quit his job as a G.D. Searle consultant and became a NutraSweet opponent (Gordon 1987, page 503 of US Senate 1987). Dr. Woodrow Monte filed for reconsideration of his petition for a hearing in Arizona. He was granted a hearing for April, 1985 (Gordon 1987, page 507 of US Senate 1987).
- In April 1985, in an unusual and secret maneuver, the Arizona legislature removed the text in a Toxic Waste Bill and used it to pass a bill which banned the regulation of FDA-approved food additives (Gordon 1987, page 508 of US Senate 1987). This bill scuttled the hearing that Dr. Monte had been promised.
- On May 7, 1985, the U.S. Senate heard testimony relating to an amendment put forth by Senator Howard Metzenbaum requiring the quantity of Aspartame to be labeled (Congressional Record 1985a). It is nearly impossible for a person to determine what quantity of Aspartame they are ingesting unless it is labeled. Senator Orrin Hatch of Utah led the fight (along with G.D. Searle) against the labeling amendment. The amendment was defeated.
- Those voting against the amendment included:
Abdnor, Armstrong, Baucus, Bentsen, Biden, Bingaman, Boren, Boschwitz, Bradley, Bumpers, Cochran, Cohen, D'Amato, Danforth, DeConcini, Denton, Dixon, Dole, Domenici, Durenberger, Evans, Ford, Garn, Goldwater, Gore, Gorton, Gramm, Gassley, Hatch, Hawkins, Hecht, Heflin, Heinz, Helms, Hollings, Humphrey, Inouye, Kassebaum, Kasten, Laxalt, Leahy, Levin, Lugar, Mattingly, McClure, McConnell, Mitchell, Murkowski, Nickles, Nunn, Packwood, Pressler, Pryor, Quayle, Riegle, Roth, Rudman, Sasser, Simpson, Stafford, Stevens, Symms, Thurmond, Tribe, Wallop, Warner, Wilson, Zorinsky.
- Those voting for the amendment included:
Burdick, Byrd, Chafee, Chiles, Cranston, Dodd, Eagleton, Glenn, Harkin, Hart, Hatfield, Johnston, Kennedy, Kerry, Lautenberg, Long, Mathias, Matsunaga, Melcher, Metzenbaum, Moynihan, Pell, Proxmire, Rockefeller, Sarbanes, Simon, Spector.
- On August 1, 1985, Senator Howard Metzenbaum of Ohio introduced a bill entitled "Aspartame Safety Act of 1985" which required quantity labeling of Aspartame on food items and mandated that there be a moratorium on new uses of Aspartame until independent tests could be conducted under the auspices of the National Institutes of Health (Metzenbaum 1985). Testimony was submitted for the record. The bill was submitted to a Senate committee, where it died.
- After suffering a $28 million dollar loss in the previous year, selling off 30 subsidiaries, and having suits filed by 780 women - claiming that G.D. Searle's intrauterine device caused them pelvic inflammatory disease, G.D. Searle sold out to the chemical company, Monsanto (Gordon 1987, page 509 of US Senate 1987). Monsanto then created the NutraSweet Company as a subsidiary separate from G.D. Searle.
- 14,400,000 pounds of Aspartame were consumed in the U.S. in 1985 (USDA 1988).
The Year 1986:
- Community Nutrition Institute (CNI) filed suit against the FDA in District Court claiming that the FDA did not follow proper procedure in approving Aspartame for beverages and that they should have held a public hearing before giving final approval (Farber 1989, page 39). After the District Court dismissed their suit and the D.C. Circuit Court of Appeals denied their request for a hearing - stating that they failed to "raise any material issues of fact that require the FDA to grant a hearing," CNI stated:
...where the holding of a public hearing is no longer a responsible part of the food additive process, the F.D.A. and the appeals court have increased the likelihood that unsafe food additives will reach the market.
- In July 1986, the U.S. General Accounting Office (GAO) published the results of an investigation of five former government employees involved in the Aspartame approval process who took jobs linked to the Aspartame industry (GAO 1986)
- 15,700,000 pounds of Aspartame were consumed in the U.S. in 1986 (USDA 1988).
The Year 1987:
- The United Press reported on October 12, 1987 that more than 10 federal officials involved in the NutraSweet decision took jobs in the private sector which were linked to the Aspartame industry (Gordon 1987, page 495 of US Senate 1987).
- On November 3, 1987 a hearing was held in a U.S. Senate Committee to address the issue of Aspartame safety and labeling (US Senate 1987). Senator Orin Hatch again successfully blocked any labeling requirements.
- In June 1987, the U.S. General Accounting Office (GAO) published the results of an investigation which looked into whether the FDA followed its required approval process (GAO 1987). The report concluded:
"Because FDA followed its required approval process in approving Aspartame and monitors adverse reactions and ongoing Aspartame research, GAO is making no recommendations."
It is important to note that the author of the report specifically stated on the first page:
"We did not evaluate the scientific issues raised concerning the studies used for Aspartame's approval or FDA's resolution of these issues, nor did we determine Aspartame's safety. We do not have such scientific expertise.
- The GAO appeared to be interested only in whether or not the FDA took the legally appropriate steps and not if FDA's decisions were based on the facts or made any sense.
- They were not interested in the fact that CFSAN's evaluation of the Bressler report was a "whitewash" in the words of the head scientist of the CFSAN team.
- They were not interested in the severe reactions suffered by many of the animals in the pre-approval studies.
- They were not interested in the countless, major flaws in the pre-approval studies, as described earlier.
- They were not interested in the fact that the FDA Commissioner, who later consulted for the G.D. Searle Public Relations firm (at $1,000 per day), over-ruled the Public Board of Inquiry (PBOI) experts and over-ruled his own chosen scientific experts in order to approve Aspartame.
- They were not interested that the FDA decided to allow G.D. Searle to pay UAREP $500,000 to "validate" 15 of their studies.
- They were only interested in whether the legally required steps were taken. Even with the limited scope of the GAO investigation, they made numerous factual errors in their report, some of which are detailed in the letter from former FDA Investigator and Toxicologist Dr. Adrian Gross presented before the U.S. Senate in 1987 (Gross 1987b, page 11). Dr. Gross concludes:
"Although in their report the GAO expresses the view that the FDA 'followed its required process in approving Aspartame (for marketing)' I would sharply disagree with such evaluation. Although the FDA may have gone through the motions or it may have given the appearance of such a process being in place here, the people of this country expect and require a great deal more from that agency charged with protecting their public health. In addition to mere facade or window-dressing on the part of the FDA, they require a thorough and scientifically based evaluation by the Agency on the safety of the products it regulates.
"Unfortunately this has clearly not been the case here. And without this kind of assurance, any such 'process' or dance represents no more than a farce and a mockery of what is truly required."
- An estimated 17,100,000 pounds of Aspartame were consumed in the U.S. in 1987 (USDA 1988). NutraSweet stopped providing consumption data to the USDA after 1987. It is much easier for NutraSweet scientists to create inaccurate Aspartame consumption figures when the total number of pounds sold is not publicly available, or is inaccurate when it is given out publicly.
The Year 1988:
- In August 1988, Aspartame was approved for use in Brazil (Monsanto 1990). Thanks to a massive advertising campaign, at the end of 1990, 150 products were sweetened exclusively by Aspartame.
The Year 1990:
- In May 1990, NutraSweet opened a production facility in Sao Jose dos Campos, Brazil (Monsanto 1990). There were no diet foods in Brazil in the 1980s.
The Year 1991:
- NutraSweet joined with its long-time partner, Ajinomoto Co. Inc. of Japan to begin building an Aspartame manufacturing plant in Gravelines, France (Monsanto 1991).
- The NutraSweet Company began a project to develop a new artificial sweetener called "Sweetener 2000", which is said to be approximately 10,000 times sweeter than sugar. The chemical composition of this sweetener was not detailed in Monsanto's Annual Report. NutraSweet's plan was to get this new sweetener to the market by the end of the decade (Monsanto 1991).
The Year 1992:
- NutraSweet signed agreements with the Coca-Cola Co. and PepsiCo Inc. "stipulating The NutraSweet Company as their preferred supplier of Aspartame (Monsanto 1992).
- NutraSweet stated that one of their options for increasing sales in the carbonated soft drink market is to prepare "higher-concentration formulations that use more Aspartame" (Monsanto 1992).
- The FDA approved the NutraSweet Company's application to market Aspartame in bulk form. NutraSweet markets the product under the name "NutraSweet Spoonful" (Monsanto 1992).
- The patent for Aspartame expired on December 14, 1992 opening up the market to other companies such as Holland Sweetener Company (Monsanto 1992).
The Year 1993:
- In mid-1993, NutraSweet and long-time partner, Ajinomoto Co. of Japan began producing Aspartame from the new production facility in Gravelines, France (Monsanto 1993).
- NutraSweet began a joint venture with Nestle Mexico to bring Aspartame to Mexico (Monsanto 1993).
- NutraSweet began to explore other Aspartame marketing opportunities in Mexico (Monsanto 1993).
The Year 1994:
- NutraSweet introduced tabletop Aspartame products to Mexico, Hungary, Uganda, Ecuador, Romania, Uruguay, and Paraguay (Monsanto 1994).
- Aspartame's net sales outside of the U.S. accounted for 10 percent of all net sales (Monsanto 1994).
- As detailed by investigative journalist Gregory Gordon (Gordon 1996):
"Between the early 1980s and 1994, scientists at the National Institutes of Environmental Health Sciences (NIEHS) proposed at least four times that the government's leading program for toxicology research fund such studies." (I think these paragraphs need to be switched)
"The government scientists said they wanted the National Toxicology Program to conduct animal studies to resolve questions about the sweetener's cancer risks."
"After each of these "nominations," NIEHS officials elected not to pursue the research at the urging of FDA officials, who said they were satisfied with industry-sponsored research that found no health risks."
- NutraSweet announced plans to market Aspartame tabletop sweeteners in 1995 throughout Southeast Asia. They plan to introduce Aspartame to India and to test market an Aspartame tabletop sweetener in China during 1995 (Monsanto 1994).
The Year 1995:
- In a June 12, 1995 article which appeared in Food Chemical News, Thomas Wilcox, the FDA epidemiology branch chief was quoted as saying, "FDA has no further plans to continue to collect adverse reaction reports or monitor research periodically done on Aspartame." (Food 1995) (See: Food 1995. "Aspartame Adverse Reaction Reports Down in1994 from 1985 Peak: FDA," Food Chemical News, June 12, 1995, page 27.)
- Monsanto/NutraSweet begins to test market Equal in Shanghi, China. It is part of a plan to push their poison on 60 million Chinese in the coastal cities (Millman 1995).
The Year 1996:
- Distinguished Neuroscientist research, Dr. John W. Olney, publishes research showing that Aspartame may be a brain tumor agent. He shows that Aspartame caused brain cancer in pre-approval research, that a breakdown product of Aspartame has caused mutations in vitro, and that in the period of 4 to 13 years after approval there was a significant increase in the conversion of less deadly brain tumors to much more deadly brain tumors (same types as seen in pre-approval research) in susceptible populations (Olney 1996). Monsanto and the FDA respond with irrelevant statements regarding the overall brain tumor rate (NutraSweet 1996).
- In early October, NutraSweet Kelco, the maker of the artificial sweetener Aspartame, discovered that an academic journal was about to publish an unflattering study about its product. The firm, a unit of Monsanto, was apparently unaware of the study's conclusion-that use of Aspartame might be linked to a rise in glioblastoma incidence-but felt threatened enough to contact journal editor-in-chief, Michael Hart. He says the firm asked to meet with him for "an in depth review of the subject matter" before publication.
- NutraSweet "did not overtly make any threats about any actions they would take", says Hart, but he immediately consulted with attorneys at his parent institution, the University of Wisconsin (Madison). He also informed NutraSweet that he would not consider withdrawing the article, due to appear in November.
- On Oct 24, Hart received another fax and this time, he says, it seems that the firm had seen the study by University of Washington psychiatrist John Olney. NutraSweet said that outside reviewers had found omissions and distortions in the study, so, "in the interest of scientific accuracy and fairness" it asked to publish an article in the same issue on brain-tumor trends. "I told them that we had already gone to press and that I wouldn't have entertained the thought of publishing a rebuttal article in the same issue anyway", says Hart.
- NutraSweet says that it wanted to respond to the study because Olney had already "apparently widely distributed his manuscript . . . to a variety of non-scientific broadcast and print media outlets. We requested that [Hart] publish a simultaneous response, a request that-while not unprecedented-he denied", says company spokesman Richard Nelson. "The suggestion that we attempted to suppress publication of [Olney's] manuscript is outrageous and unfounded", adds Nelson.
- Hart says his attorneys advised him that the firm might seek an injunction to stop publication. After receiving the second fax, he called NutraSweet and, after agreeing to consider publishing some correspondence rebutting Olney's study, Hart says he immediately received "a blitz of letters". (See: Lancet; 11/23/96, Vol. 348 Issue 9039, p1435, 1/2p.)
STUDIES AND DEVELOPMENTS
WITHIN THE PAST DECADE (1988-present)
- On May 13, 1998, the University of Barcelona produced, in final form, its study clearly showing that Aspartame, labeled with a carbon-14 isotope, was transformed into formaldehyde in the bodies of the living specimens, and that when they were examined later, the radioactive-tagged formaldehyde had spread throughout the vital organs of their bodies.
The chemical breakdown of Aspartame in the human body is described as follows: Methanol, from Aspartame, is released in the small intestine when the methyl group of Aspartame encounters the enzyme chymotrypsin. Free methanol begins to form in liquid Aspartame-containing products at temperatures above 86oF.
- The methanol is converted to formaldehyde. The formaldehyde converts to formic acid (ant sting poison). Formic acid is toxic and is used as an activator to strip epoxy and urethane coatings. Phenylalanine and aspartic acid (90% of Aspartame) are amino acids normally used in synthesis of protoplasm when supplied by the foods eaten by humans. However, when unaccompanied by other amino acids, they are neurotoxic.
- The FDA has established at least 92 medical/health problems have symptoms associated with Aspartame and include, but are not limited to-abdominal pain, anxiety attacks, Arthritis, Asthma and asthmatic reactions, bloating, edema (fluid retention), blood sugar control problems (Hypoglycemia or Hyperglycemia), brain cancer (pre-approval studies in animals), breathing difficulties, burning eyes or throat, burning urination, chest pains, chronic cough, chronic fatigue, confusion, death, depression, diarrhea, dizziness, excessive thirst or hunger, flushing of face, hair loss (baldness) or thinning of hair, headaches/migraines dizziness, hearing loss, heart palpitations, hives (urticaria), hypertension (high blood pressure), impotency and sexual problems, insomnia, irritability, joint pains, laryngitis, marked personality changes, memory loss, menstrual problems or changes, migraines and severe headaches (triggered or caused from chronic intake), muscle spasms, nausea or vomiting, seizures and convulsions, slurring of speech, swallowing pain, tachycardia, tremors, tinnitus, vertigo, vision loss, and/or weight gain.
- Aspartame disease mimics symptoms or worsens the following diseases;
Fibromyalgia, Arthritis, Multiple Sclerosis (MS), Parkinson's Disease, Lupus, Diabetes and diabetic complications, Epilepsy, Alzheimer's Disease, birth defects, Chronic Fatigue Syndrome, Lymphoma, Lyme Disease, Attention Deficit Disorder (ADD).
- Recent studies support the FDA listing. These studies include but are not limited to:
- Smith, J.D., C.M. Terpening, S. Schmidt, J. Gums, 2001. "Relief of Fibromyalgia Symptoms Following Descontinuation of Dietary, Excitotoxins," Annals of Pharmacotherapy, Volume 35, pages 702-706, 2001.
- Konen, J.A., T.L. Sia, M. Czuchry, P.M. Stuntz, G.S. Bahr, T.M. Barth., D.F. Dansereau, 2000. "Perceived Memory Impairment in Aspartame Users,"Presented at the Society for Neuroscience 30th Annual Meeting, November 6, 2000.
- Kovatsi, L., M. Tsouggas, 2001. "The effect of oral Aspartame administration on the balance of magnesium in the rat," Magnesium Research, Volume 14, Number 3, pages, 189-194.
- Newman, L.C., R.B. Lipton, 2001. "Migraine MLT-down: an unusual presentation of migraine in patients with Aspartame-triggered headaches," Headache, Volume 41, Number 9, pages 899-901.
- Hill, A.M., D.V. Belsito, 2003. "Systemic contact dermatitis of the eyelids by formaldehyde derived from Aspartame?" Contact Dermatitis, Volume 49, Number 5, pages 258-259.
- Christian, B., K. McConnaughey, et al., 2004. "Chronic Aspartame affects maze performance, brain cholinergic receptors and Na+, K+-ATPase in rats," Pharmacology, Biochemistry and Behavior, Volume 78, Number 1, pages 121-127.
- On or about September 8, 2004 an affidavit was signed describing the initial third world studies and the health hazards of Aspartame. These studies conducted in 1983/84 by the J.D. Searle Company were translated to English from Spanish in 1984. The "double blind" studies showed conclusive evidence that Aspartame caused severe health problems and even death to the exposed study group. According to the Affidavit, the doctor directing the studies has been missing since the approval of Aspartame in1984. The affidavit also describes how the affiant was directed by J.D. Searle officials to destroy all records of the studies - including filed notes and/or translations - possessed by the affiant. The affiant describes in detail how the translations were forwarded upon completion to J.D. Searle corporate offices in Illinois.
- Defendants are in the business of manufacturing, selling, and marketing the sugar substitute product known as Aspartame. Aspartame is also known as NutraSweet.
- Despite the voluminous studies showing the harmful health effects of the ingestion of Aspartame, the Defendants continue to market the product and represent to the general public that Aspartame is safe and good for you.
- Such representations are untrue and known to be untrue at the time they are being made by Defendants.
- 192. Such representations are being made with the sole intent and purpose of convincing Plaintiff and other similarly situated consumers to purchase products containing Aspartame.
CAUSES OF ACTION
(Racketeer Influenced and Corrupt Organizations)
- Plaintiff incorporates paragraphs 1 through 192 as if fully set forth at this place.
- Defendant NutraSweet is a company organized under the laws of the state of Delaware and conducts business and sells products throughout the United States and around the world.
- Said sales by Defendant NutraSweet are in part assisted and promoted by the words and actions of Defendant Dr. Moser.
- NutraSweet has been and continues to be promoted as a healthful sugar substitute and termed a "free food" by Defendant American Diabetes Association.
- Defendants and each of them have promoted the health and safety of Aspartame/NutraSweet through the use of the wires and mails.
- Those representations made by the Defendants herein via the wires and mails were false.
- When made, the Defendants knew said claims through the mail and over the wires were false.
- Defendants misrepresentations were made with the intent and purpose that the general consumer would rely on said representations.
- Plaintiff herein and other similarly situated consumers did rely on the misrepresentations to Plaintiff's detriment.
- The use of the wires and the mails to promote, send, and disseminate false information is of the type described in 18 U.S.C.§1961 in furtherance of the business enterprise of the Defendants.
- 18 U.S.C. § 1961 defines such activity as "racketeering activity".
- That over a period covering at least 10 years prior to this complaint said defendants have engaged in a pattern of racketeering activity as defined in 18 U.S.C.§ 1961(5);
(1) --------- Letter on NutraSweet letter head from Defendant Dr. Moser, via U.S. Mail to Jennifer Cohen claiming that Aspartame is a healthful product dated May 20, 1997;
(2) ---------- Defendants via the wire, mails, print and internet media have represented the healthful qualities of NutraSweet/Aspartame;
(3)---------- Defendant NutraSweet's continuous and systematic funding of fraudulent and misleading studies for submission to the consumer and the Food and Drug Administration.
(4)---------- Defendant American Diabetes Association was put on notice as early as June 1987 that Aspartame was not a healthy sugar substitute, but continues through the present to represent on its website that NutraSweet/Aspartame is a "free food" and is healthy and recommended for use.
(5) ----------Defendant American Diabetes Association continues to advertise via print and television advertisements that Aspartame is a healthy sugar substitute contrary to the medical evidence.
- The coordinated actions of the above named Defendants and each of them results in sales of Aspartame and corresponding profits to the NutraSweet Company and the Defendant American Diabetes Association. Such activities constitute a conspiracy to use the mails and wires to defraud and inflict harm upon the consumer.
- NutraSweet is a business enterprise
- All Defendants hereto have derived income either directly or indirectly from the promotion and sale of NutraSweet (Aspartame), all in violation of 18 U.S.C..§ 1962.
- Pursuant to 18 U.S.C. § 1964, the court should issue an appropriate order enjoining Defendants from engaging in such racketeering activity and to prohibit them and each of them from profiting thereby and ordering that said Defendants NutraSweet and American Diabetes Association be dissolved, prohibiting Defendants from engaging in such activity in the future and requiring said Defendants to disgorge any and all profits received in a manner and method acceptable to the court for the general welfare of the consuming public.
- Plaintiff has been damaged by the activities of the Defendants herein in an amount in excess of $50,000,000.00
VIOLATIONS OF CALIFORNIA CONSUMERS LEGAL
CIVIL CODE SECTIONS 1770(a)(2), (5) & (7)
- Plaintiff realleges the allegations contained in paragraphs 1 through 209 above as if fully set forth at this place.
- The actions of Defendants as described above constitute deceptive acts or practices undertaken by the Defendants in the transaction with the Plaintiff and other similarly situated consumers which were intended to result and which resulted in the sale of goods to Plaintiff and others similarly situated.
- Defendants knowingly continued to misrepresent the source, sponsorship, approval, or certification of NutraSweet/Aspartame to the Plaintiff herein and to the consuming public.
- Defendants knowingly continue to misrepresent NutraSweet/Aspartame have characteristics, ingredients, uses, or benefits which they do not have.
- Defendants have knowingly continued to misrepresent that NutraSweet/Aspartame are of a particular standard, quality, or grade when in fact the sugar substitute Aspartame, is known to Defendant NutraSweet to be a neurotoxin and hazardous to the health of Plaintiff and other consumers.
- The intentionally deceptive acts of Defendants, by knowingly continuing to misrepresent, are per se violations of California Civil Code Sections 1770(a)(2), (5), and (7) and have damaged Plaintiff and other similarly situated consumers in an amount to be proven at trial.
- Pursuant to California Civil Code, Plaintiff is asserting his rights to appear as a private Attorney General for the health and safety of the consuming public and is asserting that he is representative of class of consumers whom have been injured by Defendants actions as described herein.
- Plaintiff realleges the allegations contained in paragraphs 1 through 216 of this Complaint as if fully set forth at this place.
- The Defendants through marketing and advertising have stated to the consuming public that NutraSweet/Aspartame is safe and a healthful product.
- At the time these statements were made these statements were false.
- The statements made by Defendants about NutraSweet/Aspartame were material statements in that but for those statements the consuming public would not have purchased the products containing NutraSweet/Aspartame.
- Defendants either knew or should have known the statements being made via its world wide advertising of NutraSweet/Aspartame were false or Defendants were unaware of whether the statements were true at the time the statements were made.
- The Plaintiff did not know that the statements made by Defendants concerning NutraSweet/Aspartame were false.
- The Defendants intended for the Plaintiff to rely upon the statements made about NutraSweet/Aspartame and intended Plaintiff and other similarly situated consumers to act upon said reliance in a manner reasonably contemplated by Defendants; that being the purchase of the products for consumption by the consumer.
- Plaintiff did rely upon the truth of the statements made by Defendants about the NutraSweet/Aspartame products and the health and lifestyle benefits available to Plaintiff by consuming those products.
- Plaintiff's reliance upon the statements made by Defendants concerning the benefits of consuming NutraSweet/Aspartame was reasonable under all the circumstances.
- The Plaintiff and other similarly situated consumers suffered damages to their health, directly and proximately caused by reliance on Defendants' false statements and advertising regarding the benefits of NutraSweet/Aspartame.
- As a direct and proximate result of Defendants' knowing misrepresentation to the consumer of the health benefits of the NutraSweet/Aspartame when in the chemical Aspartame, is a documented health hazard, the Plaintiff and other similarly situated consumers have been damaged and have sustained monetary damages in excess of $100,000,000.00.
BREACH OF IMPLIED WARRANTY OF FITNESS FOR A
California Commercial Code §2315
- Plaintiff realleges the allegations contained in paragraphs 1 through 228 of this Complaint as if fully set forth at this place.
- Defendants intentionally placed into the stream of commerce NutraSweet/Aspartame specifically for wholesale and retail sales to the general public consumer.
- As a direct and proximate result of said placement into the stream of commerce, the Plaintiff purchased said products.
- Such a purchase and sale of a product as described herein by and between Plaintiff and Defendant is the type of transaction anticipated and governed by the California Commercial Code.
- At the time of the transaction described herein, Defendants knew or should have known that the Plaintiff purchased the above noted NutraSweet/Aspartame infused product for the particular purpose of ingesting the product.
- At the time of purchase and as a basis for the purchase, Plaintiffs relied upon Defendants' skill and judgment to select and furnish to Plaintiff goods suitable for ingestion.
- Plaintiff's reliance upon Defendants' skill, judgment and expertise was reasonable in light of Defendant's representations and advertising as described above in this Complaint.
- Pursuant to California Commercial Code §2315, there exists an implied warranty by Defendants that NutraSweet/Aspartame shall be fit for such purpose of consumption by the Plaintiff.
- Despite scientific evidence to the contrary, Defendants, by the sale of NutraSweet/Aspartame to the Plaintiff, have breached the implied warranty of fitness for a particular purpose as imposed by California Commercial Code §2315.
- Defendants' breach of said statute has caused Plaintiff injury and has damaged Plaintiff and other similarly situated consumers in an amount in excess of $100,000,000.00.
BREACH OF IMPLIED WARRANTY OF
CALIFORNIA COMMERCIAL CODE §2314
- Plaintiff real1eges the allegations contained in paragraphs 1 through 237 of this Complaint as if fully set forth at this place.
- California Commercial Code §2314 provides: "...a warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is a merchant with respect to goods of that kind."
- Pursuant to California Commercial Code §2314 the serving for value of food or drink to be consumed either on the premises or elsewhere, is a sale.
- California Commercial Code §2314 provides that for goods to be merchantable, said goods are fit for the ordinary purposes for which such goods are used ...and are adequately contained, packaged, and labeled as the agreement may require; and conform to the promises or affirmations of fact made on the container or label, if any.
- Defendants are sellers of and are a merchant with respect to NutraSweet/Aspartame.
- NutraSweet/Aspartame is specifically manufactured by Defendants to be consumed by Plaintiff and other similarly situated consumers, either on premises at the location of the sale or elsewhere.
- As a direct and proximate result of Defendants' use of the neurotoxic chemical, Aspartame, NutraSweet/Equal is not merchantable and is not fit for the ordinary purpose for which the product is used.
- The use of the toxic chemical Aspartame in the manufacture of NutraSweet/Equal is a breach of the implied warranty of merchantability proscribed by California Commercial Code §2314.
- Defendants' breach of said statute has injured Plaintiff and other similarly situated consumers, and said injury and damage is in an amount in excess of $100,000,000.00.
VIOLATIONS OF CALIFORNIA CIVIL CODE
- Plaintiff realleges paragraphs 1 through 246 as if fully set forth at this place.
- Plaintiff's have suffered damage as a result of the use and employment by the Defendants of the methods and acts complained of in Count IV above.
- Pursuant to California Civil Code § 1781, Plaintiff believes that he is of a class of consumers that are similarly situated and that he is entitled to bring this action for and on behalf of himself and such other consumers.
- Plaintiff alleges that it is impracticable to bring all of the millions of individual members of the class of consumers that unwittingly consume the product Aspartame and suffered damage thereby all on a continuing daily basis.
- Plaintiff alleges that the questions of law and/or fact are substantially similar and predominate over the questions affecting the individual members.
- The claims of the Plaintiff in this case are typical of the claims of the class.
- Pursuant to § 1782, Plaintiff herein asserts that he has given the required notice to the above named defendants and has demanded therein that remedial action be taken.
- Plaintiff and other similarly situated consumers request injunctive relief from the activities of the Defendants herein.
- Plaintiff realleges the allegations contained in paragraphs 1 through 254 of this Complaint as if fully set forth at this place.
- Defendants continue to use the neurotoxic chemical Aspartame as a sugar substitute/sweetener in NutraSweet despite the known health and medical hazards of such use.
- Defendant continues to deceptively and fraudulently advertise NutraSweet/Equal/Aspartame as healthy products, despite the known health hazards of the chemical.
- For so long as the these products are allowed to remain available to Plaintiff and marketed and sold by Defendants to the consuming public, Plaintiff herein and the consuming public are being irreparably harmed by Defendants actions of manufacturing marketing, and selling the neurotoxic additive Aspartame, and its derivatives.
- Plaintiff and other similarly situated consumers have no other remedy at law or equity but to request that the Defendants be enjoined and restrained from the use of the chemical Aspartame as a sugar substitute/sweetener in any of its products.
WHEREFORE, Plaintiff prays for relief as follows:
As to Count I:
As to Count II:
- 1. For an Order from this court enjoining Defendants from engaging in racketeering activity including the manufacture and sale of NutraSweet;
- 2. For a money judgment fully and fairly compensating Plaintiff herein for damages suffered as result of Defendants' violations and acts.
- 3. For an order trebling the damages and awarding attorney fees and court costs incurred by Plaintiff's as allowed by statute.
- 1. For an Order from this court finding the Defendants herein and each of them have violated the California Consumers Legal Remedies Act;
- 2. For a money judgment fully and fairly compensating Plaintiffs herein for damages suffered as result of Defendants' violation.
As to Count III:
As to Count IV:
- 3. For an Order from this court finding the Defendants herein and each of them engaged in acts of willful fraud upon Plaintiffs;
- 4. For a money judgment fully and fairly compensating Plaintiffs herein for damages suffered as result of Defendants' fraudulent actions;
As to Count V:
- 5. For an Order from this court finding the Defendants herein and each of them breached the implied warranty of fitness for a particular purpose as found in California Commercial Code §2315;
- 6. For a money judgment fully and fairly compensating Plaintiff's herein for damages suffered as result of Defendants' violation;
As to Count VI:
- 7. For an Order from this court finding the Defendants herein and each of them breached the implied warranty of merchantability as found in California Commercial Code §2314;
- 8. For a money judgment fully and fairly compensating Plaintiffs herein for damages suffered as result of Defendants' violation;
As to Count VII:
- 1. For an Order from this court permanently enjoining the Defendants herein from producing, manufacturing, processing, selling or using the neurotoxic artificial sweetening chemical Aspartame, in any product manufactured or sold by Defendants.
- 9. For an Order from this court permanently enjoining the Defendants herein from producing, manufacturing, processing, selling or using the neurotoxic artificial sweetening chemical Aspartame, in any product manufactured or sold by Defendants.
- 10. And, for such other relief as the court deems just and proper in the premises.
Dated this _____ day of September, 2004
Joe Bellon, Pro Se Plaintiff
DEMAND IS HEREBY MADE FOR A TRIAL BY JURY OF ALL ISSUES PRESENTED IN THIS COMPLAINT TRIABLE TO A JURY
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Updated September 15th, 2004