|
|
|
| The University of Iowa College of Medicine has a long history of cooperation with food and drug industry interests. In 1967, the Mead-Johnson Professorship in the Department of Pediatrics was established by the Mead-Johnson and Company Foundation, Inc. | | Submitted by fedup | 2007-06-15 11:40:32 | and Lloyd J. Filer, Jr., M.D., Ph.D., moved from Mead-Johnson (a producer of infant formula) to the University of Iowa College of Medicine, where he served as Mead-Johnson Professor from 1967 through 1977.
In 1969-70, Filer chaired a special FDA "scientific" committee to evaluate the safety of glutamic acid (often referred to as "glutamate") for babies. Not withstanding the fact that Olney had demonstrated that glutamic acid caused brain lesions and neuroendocrine disorders in laboratory animals, with infant animals being most at risk, Filer's committee concluded that glutamate was safe.
Subsequently, the committee was investigated, and most of its members were found to have close financial ties to the food industry (Gillette, 1972). Chairman Filer, then Mead-Johnson Professor at the University of Iowa, was found to be receiving money from both the baby food industry and the glutamate industry. But the FDA never challenged the Filer committee's conclusion that glutamate fed to infants was safe.
In 1979, Filer, Garattini, Kare, Reynolds, and Wurtman, edited the book Glutamic Acid: Advances in Biochemistry and Physiology. Stegink contributed to six articles. The book was a compilation of the papers from a symposium held in Milan, Italy, in 1978. The symposium was organized in response to a less than satisfactory outcome of the Federation of American Societies for Experimental Biology (FASEB)'s 1978 "Evaluation of the Health Aspects of Certain Glutamates as Food Ingredients," and became the basis for FASEB's 1980 "Evaluation of the Health Aspects of Certain Glutamates as Food Ingredients Supplemental Review and Evaluation." (FASEB, 1980) Glutamate industry spokespersons claim the book demonstrates that MSG is "safe."
The Iowa/Illinois animal studies were done between 1971 and 1979. In 1991, Olney testified before a FASEB Expert Panel reviewing data on the safety/toxicity of MSG. An excerpt from the text of that presentation, which follows in Appendix B, describes some of his interaction with these researchers, and concludes:
In summary, the record shows that FDA for two decades has been assuring the public that glutamate is safe, based almost exclusively on certain industry-generated monkey data which appear upon close scrutiny to be seriously flawed, unreliable and spurious. However, even if these data were not flawed, unreliable and spurious, it is obvious from industry's own finding, shown in Fig. 1 above, that the pharmacokinetics of glutamate absorption and/or metabolism are so disparate between monkeys and man that monkeys, despite their phylogenetic closeness to humans, must be regarded as a singularly inappropriate animal model for evaluating oral glutamate safety. The same oral dose of glutamate that causes a dramatic increase in blood glutamate concentrations in humans, causes no increase at all in monkeys. Therefore, it is difficult to understand why so much money and effort was expended on oral glutamate monkey studies, unless the goal was to amass an unchallengeable mountain of negative evidence that could serve as basis for fostering the misleading impression, and fueling the spurious argument, that if monkeys are resistant to glutamate-induced brain damage, other primates, including humans, must be similarly resistant (Olney, 1993).
Lest there be any confusion, note that it is the study of sub-human primates, not the study of mice, that is largely irrelevant to an understanding of the effects of MSG on humans. Mice quite closely approximate the human condition.
The work that demonstrates that glutamic acid causes brain lesions and neuroendocrine disorders in experimental animals has been replicated hundreds of times by neuroscientists. In contrast, almost every published study sponsored by the glutamate industry has concluded that glutamic acid is "safe." Nemeroff (1981), reviewing studies of the safety/toxicity of MSG stated unequivocally that "...not one single [primate] study has truly replicated the methods utilized by Olney, making evaluation of the available [industry] data impossible."
Umami: the alleged fifth basic taste
Ajinomoto has attempted to establish that there is a unique taste, a fifth basic taste, associated with monosodium glutamate. To debate the veracity of such a claim is beyond the scope of this paper. However, considering the fact that such a claim has been made is germane to a discussion of the safety of monosodium glutamate. The scientific literature suggests that only those in the employ of Ajinomoto are interested in proving that Umami is a fifth taste sensation. Moreover, reports from MSG-sensitive consumers suggest that if monosodium glutamate (and other MSG-containing ingredients) had a unique taste, people who were sensitive to the substance, who claim to want to avoid it, would be highly motivated to identify that taste and thereby avoid ingesting MSG–which they claim they are not able to do. It is my personal opinion that the concept of umami has been developed in an effort to legitimize the use of monosodium glutamate in food.
The Epidemiologic Study
To defend themselves against epidemiologic studies indicating that 25-30 per cent of the population reacted to monosodium glutamate (Reif-Lehrer, 1977), and against individual reports of human adverse reactions that included migraine headache, seizures, asthma, and depression, the glutamate industry built the fiction that a few people might react to monosodium glutamate with the "Chinese restaurant syndrome:" "burning," "tightness," and "numbness," all occurring at the same time, within two hours following ingestion. Virtually unchallenged, they effectively suppressed the information that other reactions to monosodium glutamate occurred as well, and that some reactions are delayed by as much as 48 hours.
The industry produced a questionnaire study that listed "18 food-associated symptoms," and asked subjects "the time of onset of each symptom [if any] after the start of a meal." (No test meal was provided.). Finding that 1.8 per cent of their 3,222 respondents marked "burning," "tightness," and "numbness," all occurring at the same time, and commencing between 10 minutes and 2 hours after the start of a meal, the authors concluded that 1.8 per cent of the population suffered "Chinese restaurant syndrome" or sensitivity to monosodium glutamate (Kerr et al, 1979). The fact that an additional 41.2 per cent of the subjects reacted with chest pain, dizziness, headache, palpitation, weakness, nausea/vomiting, abdominal cramps, chills, diarrhea, heartburn, unusual thirst, unusual perspiration, flushing sensation in face or chest, and tingling was ignored. Migraine headache, seizures, tachycardia, hives, skin rash, and depression, which were not offered as options, were not considered. Soon the FDA began to disseminate the misinformation that approximately 2 per cent of the population might be sensitive to MSG, reacting with the mild and transitory reactions of "Chinese restaurant syndrome."
The Double-Blind Studies
In the 1980s, in the face of overwhelming evidence that monosodium glutamate kills brain cells in laboratory animals (Olney and Price, 1978, 1980), industry researchers changed their strategy. They began to claim that animal studies were not relevant to humans. They initiated a series of double-blind human studies that, they would claim, "proved" that monosodium glutamate was safe.
A number of industry-sponsored double-blind studies followed the epidemiologic study. Detailed analysis of those double-blind studies revealed that subjects, materials used, and protocols for administering test and placebo material, minimized the chance that subjects would react to the MSG test material; and that if subjects did react to the MSG test material, they would also react to the placebo. Industry researchers:
1. Use variables and methods known to minimize or be irrelevant to identification of the toxic effects of glutamic acid; then conclude that glutamic acid never produces adverse effects. Studies have focused on the relationship between "objective" parameters such as blood pressure and body temperature and ingestion of MSG.
Unless MSG sensitive people are studied, one can not legitimately draw conclusions about the relationship of the variables being studied (no matter how objective they are) to people who are sensitive to MSG. Often, these studies are used to allegedly "prove" that people who are not sensitive to MSG are not sensitive to MSG.
2. Limit the recorded adverse effects to a few generally mild and transitory reactions occurring simultaneously, such as those first reported in 1968 by Kwok and dubbed "Chinese- restaurant syndrome" (CRS): "...numbness at the back of the neck, gradually radiating to both arms and the back, general weakness and palpitation." Industry researchers do not consider migraine headache, asthma, tachycardia, arrhythmia, depression, anxiety attacks or other obviously debilitating and/or life-threatening reactions reported since 1968.
3. Make no attempt during a study to prevent subjects from ingesting food to which they might be allergic or sensitive.
4. Record reactions as reactions to monosodium glutamate or placebo material only if they occur 2 hours or less following ingestion of test or placebo material, even though many symptoms are commonly expressed much later, and reactions may persist for much longer periods.
5. Fail to report all data.
6. Draw conclusions that do not follow from the results of the study. The IGTC researchers have concluded, for example, that because approximately one third of their subjects reacted adversely to placebos containing MSG and/or aspartame, they have "proved" that reactions to MSG-containing test material are not reactions to MSG.
7. Use test material that will minimize the effect of any stated amount of glutamic acid test material in producing adverse reactions. One gram monosodium glutamate encased in capsules, and therefore guaranteeing slow release, will cause less effect than 1g monosodium glutamate sprinkled on food; and 1g monosodium glutamate modified with sucrose will cause less effect than otherwise because sucrose is known to slow monosodium glutamate uptake (Stegink, 1986).
8. Continue subjects on medications that might block the effects of MSG.
9. Using placebos to which MSG-sensitive people would react (placebos containing MSG, aspartame, carageenan or enzymes, for example), test potential subjects for sensitivity to those placebos, and eliminate any subjects who react to placebos. Researchers can be fairly certain that those who do not react to their reactive placebos will not react to monosodium glutamate test material.
10. Advertise for, and presumably use, "well subjects" – people who had never experienced any of the symptoms with which reactions to MSG are associated. (If 50 per cent of the population were sensitive to MSG, but research design precluded inclusion of that 50 per cent who were sensitive, a study claiming to assess the number of people sensitive to MSG would be invalid.)
11. Refer to studies as "randomized double-blind crossover design studies," which gives the casual reader the impression that subjects were drawn randomly from the general population. In fact, subjects are often carefully selected people who tell researchers that they have never experienced any of the adverse reactions associated with monosodium glutamate, and, under those conditions, are paid to participate in the studies. Other subjects are people, often students, paid for participating in industry-sponsored studies only if they say that they are sensitive to monosodium glutamate. In either case, the only thing in those studies that is "random" is whether subjects get their monosodium glutamate test trial first and their placebo second, or vice versa. Subjects recruited in 1993 for as yet unpublished IGTC-sponsored studies begun in 1992 by Harvard Medical School, Northwestern University Medical School, and UCLA Medical School, were paid hundreds of dollars each--only if the applying subjects (many of them students) claimed that they were sensitive to monosodium glutamate. One of my children, a Northwestern student at the time, saw the study advertised, found out the details of participation, applied for the study, and was rejected when she told the researchers that she was not very sensitive to MSG.
12. Use placebos virtually guaranteed to produce as many reactions as might be produced following ingestion of the monosodium glutamate test material. Using toxic material in both test material and placebo, researchers argue that the reactions to MSG-containing test material are not reactions to MSG because subjects also react to placebos, which are assumed to be inert. However, the use of toxic material in placebos, particularly when it is identical or similar to the MSG in the test material, makes it virtually inevitable that there will be approximately as many reactions to placebos as there are reactions to MSG test material.
Sometimes glutamate-industry researchers use MSG in placebos, but use sources of MSG different than the ingredient called monosodium glutamate. Gelatin, which always contains free glutamic acid, has been a favorite. Beginning in 1978, before aspartame was approved by the FDA for use in food, glutamate-industry researchers used aspartame in placebos (Ebert, 1991b). Over and above the fact that use of aspartame in placebos is grossly inappropriate, the fact that aspartame-containing products are supposed to carry a warning on their labels did not deter industry from using the substance, or the FDA from allowing its use. Aspartame contains phenylalanine (which adversely affects one in 15,000 Americans); aspartic acid (an excitatory amino acid); and a methyl esther. Aspartic acid and glutamic acid load on the same receptors in the brain, cause the same brain damage and neuroendocrine disorders in experimental animals, and, with the exception of blindness related to aspartame ingestion, cause virtually the same adverse reactions in humans. There are over 7,000 unsolicited reports of adverse reactions to aspartame filed with the FDA. It should surprise no one, therefore, that glutamate industry researchers find as many reactions following ingestion of an aspartame-containing placebo as they find following ingestion of monosodium glutamate test material.
Placebo reactions have also been noted in industry-sponsored animal studies. It was noted by Nemeroff (1981) that Abraham, Doughtery, Goldberg, and Coulston (1971) and Abraham, Swart, Goldberg, and Coulston (1975) found in both control and glutamic acid treated monkeys a "very small proportion of necrotic or damaged neuronal cells and oligodendrocytes... in the arcuate nuclear region of the hypothalamus." This might happen if the placebo, as well as the test material, contained small amounts of an excitotoxin identical or similar to glutamic acid.
On February 4, 1991 at the FASEB open hearing on the safety of amino acids in dietary supplements, J. Samuels raised the question of the propriety of placebo material used by the glutamate industry. Ebert rebutted, leading to a request from Sue Anne Anderson, R.D., Ph.D., Senior Staff Scientist with the Life Sciences Research Office at FASEB for information about the vehicle for administration of monosodium glutamate in IGTC-sponsored double blind studies. In a March 22, 1991 letter to Anderson, IGTC chairman Ebert responded that "since the completion of the work described in [1978], the sample has been modified to replace the sucrose with the low calorie sweetener Aspartame in both the placebo and sample with MSG." Still, no one at the FDA raised any question about the propriety of the research being submitted to the FDA by the IGTC as evidence that MSG is safe.
In 1993, J. Samuels came across the March 22, 1991 letter to Anderson in the files of the FDA; and brought the information to the attention of both FASEB and the FDA. Still, no one at the FDA raised any question about the propriety of the research being submitted to the FDA by the IGTC as evidence that MSG is safe. Not long afterward, IGTC chairman Ebert was named by FDA Commissioner David A. Kessler, M.D., to the FDA Food Advisory Committee.
The IGTC has amassed a number of double-blind studies concluding--but not demonstrating--that MSG is safe. The fact that these studies are often done at generally respected universities or medical schools, all of which required that the research be approved by medical research review committees, has public relations value. Subsequently, studies may be published in peer reviewed journals--accepted by editors who, themselves, may have ties to the food and/or drug industries.
Given the methodological flaws inherent in their work, and their unwillingness to change their protocols after flaws were pointed out to them, it would appear that IGTC researchers move from a predetermined conclusion (that their product is "safe") to design and implementation of research guaranteed to bring the reader back to that predetermined conclusion.
Suppression of Information
Interwoven with the assertion that research has demonstrated that monosodium glutamate is "safe," has been the suppression of any and all commentary or data that would say otherwise.
When there was no getting around the fact that MSG caused adverse reactions, as is the case in migraine headache, the glutamate industry and colleagues at the FDA simply did not discuss those reactions. The FASEB, in a report done for the FDA and published July, 1995, (FASEB, 1995) covered the subject of asthma in some detail, but virtually ignored the subject of migraine headache, despite the fact that 43 per cent of the reactions reported to the FDA's Adverse Reactions Monitoring System by MSG-sensitive people were reactions of migraine headache.
Suppression of information relative to the toxic potential of monosodium glutamate has included industry/FDA refusal to identify MSG when present in processed food (making confirmation or denial of MSG-sensitivity extremely difficult); industry/FDA suppression of evidence that demonstrates that ingestion of MSG places humans at risk; industry/FDA use of poor research, imprecise and contradictory terms, half-truths, and misrepresentation of fact; and FDA refusal to provide either consumers or the Court, when a defendant in a legal action, with all of the evidence that the FDA has in its files on the safety/toxicity of MSG.
As consumer pressure to expose the toxic potential of MSG continues; as the growing science on neurodegenerative disease continues to implicate glutamic acid; as a growing number of diverse disease conditions are being linked to the glutamate cascade; and as members of the United States Congress are admitting that they, personally, are sensitive to MSG, industry-inspired articles attesting to the safety of MSG are being published.
A recently published article in The Washington Post by Robert L. Wolke is a case in point (Wolke, 1998).
According to Wolke, "...a lack of scientific understanding hasn't stopped people from enjoying the benefits of MSG for more than 2,000 years." But MSG was only invented in 1908.
According to Wolke, "[FDA] remains convinced that MSG and related substances are safe food ingredients for most people when eaten at customary levels.'" But Wolke fails to mention that could leave 49 percent of the population reacting to MSG.
According to Wolke, there are only small amounts of MSG in typical servings of prepared foods. He suggests that we "contrast this with the FDA's best scientific information, which is that even hypersensitive people must eat between 500 and 2,000 milligrams of pure MSG to cause CRS symptoms." But Wolke refers to "CRS [Chinese restaurant syndrome] symptoms," and not to all of the known reactions to MSG; and Wolke ignores the fact that the FDA's "best scientific information" is not based on any scientific study; because no study even attempting to determine the least amount of processed free glutamate that might cause an adverse reaction in an MSG-sensitive person has ever been done.
The source of Wolke's information is not given.
I wrote to the Editor of the Washington Post, expounding on the bias in Wolke's article. Several days later, I found the following message from Fanny Zollicoffer of the Washington Post on my answering machine: about your "...letter to the editor about MSG, and the article we had in the food section. We'd like to publish your letter. It's being considered for the free fall page on Saturday. And I'm just calling to confirm that you wrote the letter and put your name on it and sent it to no other newspaper." When I called several days later to inquire why my letter had not appeared in the paper, I was told that the editors had decided not to print it.
Suppression of criticism of badly flawed research has been similarly effective. Questions in the form of Letters to the Editor have been refused publication by the Journal of Allergy and Clinical Immunology (Goldschmiedt et al., 1990) and Food Additives and Contaminants (Daniels, Joe, and Diachenko, 1995). (The Daniels et al. study was done at the FDA.)
When a critique of the work of Tarasoff and Kelley was sent to Food and Chemical Toxicology in the form of a Letter to the Editor, (Samuels, 1995) the Letter was accepted for publication; but approximately seven weeks later, I was informed that "after reconsideration we cannot accept your comments on the paper by Tarasoff and Kelly for publication....Our concern is that your critique could be wrongly exploited by different groups of people involved in the MSG issue, and we therefore believe it is preferable that our journal should be kept away from any possible complications" (T. Ho, personal communication, June 1, 1994).
I protested that having been accepted, I had informed others that the Letter was "in press," and that in rejecting the letter as it had, the journal was not only acting in an unprofessional manner, but would cost me a great deal of embarrassment.
After considerable correspondence with the Journal, with Bibra Toxicology International, and with Elsevier Science, I was informed that their battery of expensive solicitors had assured them that by publishing the letter the damage to reputation, if any, had been sufficiently allayed (P. Shepherd, personal communication, February 9, 1995).
According to correspondence from Christopher Lloyd, Editorial Director, Life Sciences/Earth Sciences, Elsevier Science, "...the editorial decisions both to initially accept, and then reject [the] letter were made by the Journal's Editor, Dr. J. Borzelleca." In September, 1994, Editor-in-Chief Borzelleca had told me that the delay of publication should not be of concern because he, Borzelleca, had seen a copy of the draft final report sent to the FDA by FASEB, and knew that it would be rejected by the FDA; causing there to be sufficient time for my letter to be published and considered by FASEB.
The fact that the FASEB draft final report seen by Borzelleca was allegedly confidential, will be discussed in the section entitled "The Food and Drug Administration (FDA)."
The Letter to the Editor of Food and Chemical Toxicology was published more than a year after publication of the original article. Borzelleca, who is on the faculty of the Medical College of Virginia, had blocked publication of criticism of the Tarasoff and Kelly study for almost a year. Donald F. Kirby, M.D., who has done double-blind studies for the IGTC (Ebert, 1990) is also on the faculty of The Medical College of Virginia.
Borzelleca served on the Select Committee on GRAS (Generally Regarded As Safe) Substances that published reviews of the safety of monosodium glutamate for the FDA in 1978 and 1980.
When professional peer review journals hesitate to take articles from glutamate industry researchers because their studies are badly flawed and those flaws have been pointed out to journal editors, researchers hold seminars and/or present their papers at professional meetings with abstracts printed in appropriate journals (Altman, 1994; Stevenson, 1997). Studies reported in abstract form are not peer reviewed, and letters to the editor criticizing abstracts are not generally published. The principal forum for such papers has been the American Academy of Asthma, Allergy, and Immunology (Altman, 1994; Stevenson, 1997). In addition, there are a few journals that, by policy, do not accept critical letters. Food Additives and Contaminants is one (R. Walker, personal communication, September 1, 1995).
By the end of the 1970s, industry-sponsored researchers had basically given up doing animal studies designed to convince people that MSG poses no risk to humans. They continued, however, to claim that their research had demonstrated that MSG poses no risk to humans. Through verbal argument, they attempted to suppress contradictory information.
The work of Filer, Reynolds, and Stegink has been discussed earlier (Reynolds, 1971; Reynolds, 1976; Stegink, 1975). Filer retired from academia, but continued to serve as a spokesman for The Glutamate Association and the IGTC until his death (Filer, 1993).
Reynolds moved into administration, spending time at the University of California before moving on to New York State. However, she continued to proclaim the safety of MSG. In a five page letter to FASEB, for example Reynolds, Filer, and Stegink (1991) explained that cross sections presented in their 1975 and 1976 reports, discussed briefly earlier, although labeled differently, were, indeed, identical, because the 7 day-old Macaca fascicularis monkey that ingested MSG (reported by Reynolds, et al.) was the same "...infant rhesus monkey which received 4 g/kg of MSG by stomach tube 6 h prior to brain perfusion" (reported by Stegink et al.). They assured FASEB that they could find no evidence to support the allegation that the micrograph being challenged by critics came from a previously unreported monkey (an allegation that had not been made), and explained how "the differences between [the] captions [in the Stegink et al. article and the Reynolds et al. article] may confuse the casual reader." No reader would have cause to question the contents of the Reynolds, Filer, Stegink letter unless he or she had both the 1975 and 1976 articles in hand; and then only close scrutiny will reveal that none of the animals given 4g/kg MSG in1971 referred to by Stegink et al. (one of which was allegedly the same animal pictured by Reynolds et al.) had been 7 day-old-animals. (Table 1 of the Stegink et al. study contains that information.) Reynolds et al. had claimed that the section pictured in their paper, and alleged to have been from one of the animals given 4g/kg MSG in 1971 referred to by Stegink et al., came from a 7-day-old animal.
Stegink appears to write on behalf of the safety of MSG whenever the safety of MSG is challenged (Stegink, 1993a, 1993b).
Dissemination of misinformation
The Glutamate Association has disseminated masses of misinformation designed to suppress reports of adverse or toxic reactions, and to convince consumers that monosodium glutamate is safe.
Some of their information is based on distortion of fact. For example, the statement that monosodium glutamate has been used in the orient for more than 2,000 years, or the statement that the glutamic acid in monosodium glutamate (a manufactured product that invariably contains D-glutamic acid and pyroglutamic acid as well as L-glutamic acid) is chemically identical to the glutamic acid found in unadulterated protein (which is composed of L-glutamic acid, only). One of their favorites over time has been the assertion that "other authoritative bodies" have found MSG to be safe. In general, those "other authoritative bodies" have read the FDA's summaries concluding that MSG is safe, or have received selected data provided to them by The Glutamate Association and have called that their data. When questioned, however, Hellen Keller International, one of the "authoritative bodies," was not at all pleased to hear that their name was being used in this way. They had never considered that MSG might have toxic potential. Hellen Keller International was supplementing monosodium glutamate, a widely used food additive, with vitamin A in Indonesia to counteract xerophthalmia, an eye disease caused by lack of vitamin A. (National Food Review, 1987) They did not consider that to be an endorsement of the safety of MSG (Hellen Keller International, personal telephone communication, n.d.).
Half-truths also constitute misinformation. When The Glutamate Association's Richard Cristol wrote to FASEB on April 9, 1993 that researchers had received no funding from The Glutamate Association, he didn't rule out receipt of funding from the IGTC, Ajinomoto, Campbells or other members of the glutamate industry. On page 5 of a brochure titled "Sweet, sour, salty, bitter and umami, the statement is made that "...researchers confirmed that glutamate had an L-configuration." (Umami Information Center, n.d.) It was not, however, made clear that when glutamate is generated through a manufacturing process, the glutamate will contain D-glutamate as well as L-glutamate; that pyroglutamic acid will invariably accompany manufacture; and that under certain circumstances. carcinogenic substances will also be generated.
The balance of the information disseminated by the glutamate industry has been based on conclusions drawn from their badly flawed studies.
Dirty tricks
In October, 1994, the Truth in Labeling Campaign (TLC) was formed to promote truth in labeling, with its first project being full and clear labeling of MSG. In August, 1995 TLC sued the FDA and announced plans for fund raising.
In October, 1995, the Washington Post ran a story about the Truth in Food Labeling Campaign--formed by Public Voice for Food and Health Policy and the National Consumers League for the purpose of raising funds to combat the use of mechanically separated poultry (MSP). It seemed like an innocent coincidence–until the sponsors refused to reveal the source of the grant money given to them to set up the Truth in Food Labeling Campaign, or to elaborate on projects that had been planned for the future.
In an effort to generate publicity, TLC contracted with Bacons Communications to send out press releases announcing the suit filed against the FDA. Bacons provides clipping services, mailing services, and media directories. They have offices in Chicago, Illinois. On the day following the day the releases were to go out, TLC began getting inquiries about incomplete information that had been received by fax--often a cover page, only. After receiving several such inquiries, it was ascertained that Bacons had held the releases, sending them out the day after the suit was filed, making them non newsworthy. When I made inquiry into what had happened, it became clear that the error was not due to a misunderstanding of instructions or to equipment breakdown.
In 1994, I attended an IFT Short Course "Allergies and other Adverse Reactions to Foods, Additives and Ingredients" sponsored by the IFT, The Food Allergy Center, and the University of Nebraska Food Processing Center. Presenters were Altman; Betty P. Rauch, M.B.A., Allerx Inc.; Daniel J. Skrypec, Ph.D. Kraft General Foods; and Sean F. Altekruse, D.V.M., M.P.H., FDA. According to Altman, who said what little was said about MSG, presenters had been told that I would be in the audience. It was only after the presentation was over that I discovered that prior to the presentation, Altman had given the press a manuscript that was replete with misinformation about the safety of MSG; while in her limited oral presentation, Altman had said nothing that I might question in public.
Agencies of the United States Government
The Food and Drug Administration (FDA)
Reference to the FDA has been made throughout this paper; and rightly so. Because it is the FDA that makes and enforces food labeling laws; and it is the FDA that determines whether or not MSG, or any other chemical, will be approved for use in food. Thus, the FDA holds the keys to life and death for many American people, who would hope that it is the welfare of consumers, not the profits of the food and/or drug industries, that is of concern to the FDA.
Evidence of FDA/industry cooperation will be found in the files of the FDA.
A July 13, 1990 letter from IGTC chairman Ebert to Walter Glinsmann, M.D., Associate Director of Clinical Nutrition, Division of Nutrition, FDA reads, in part "...attached are three [double-blind] protocols for your use...IGTC would be interested in your views, especially on the proposed work by Drs. Kirby and Kjos."(Ebert, 1990).
A January 2, 1991 letter from IGTC chairman Ebert to Fred R. Shank, Ph.D., Director, Center for Food Safety and Applied Nutrition, FDA, requested a scientific review session on MSG with FDA scientists. "In the past, IGTC has requested meetings with FDA staff for purposes of informal reviews of MSG research. Scientists who have carried out studies on MSG, usually in university laboratories or clinics, have presented their data to agency scientists for review and discussion." After elaborating on what the IGTC wanted covered at the meetings, the chairman continued: "As FASEB plans a one day Hearing on Free Amino Acids on February 4, 1991, it seems advisable to complete an FDA meeting prior to that date....FDA scientists who have participated in MSG research discussion in the past included among others: Drs. Shank, Hattan and Scheuplein. Others who would be key attendants include Drs. Rulls, Lin and Bailey...Members of the IGTC/TGA Executive Committee also would plan to join the meeting" (Ebert, 1991a).
A December 9, 1991 FDA Memorandum of Conference (FDA, 1991) notes that "The IGTC requested the meeting to discuss a protocol that they are currently developing for a proposed food allergy study involving MSG. We informed the visitors that we will provide our comments only after they have submitted a written protocol to us with some detailed description of the proposed study."
A September 4, 1992 FDA Memorandum of Conference (FDA, 1992b) reads: "Dr. Kimura gave me a copy of the [IGTC] request (dated 8/20/92) for a meeting with the Commissioner and a copy of the Bob MacLeod's brief response (dated 9/3/92) to the IGTC. We both agreed that once a description of their research plan (or protocols) is given to us, a meeting will be scheduled for their scientists to discuss with our review staff regarding their research plan aimed to resolve scientific issues surrounding adverse reactions allegedly caused by monosodium glutamate consumed in food."
On October 23, 1992, the FDA hosted a conference at the Center for Food Safety and Applied Nutrition, FDA. Present were Geha (Harvard Medical School), Saxon (UCLA Medical School), Patterson (Northwestern University Medical School), Ebert, (Chairman IGTC), Yoshi-hisa Sugita (IGTC), Takeshi Kimura (IGTC); and Hattan, Tollefson, Glinsman, Bailey, and Lin of the FDA (FDA, 1992a). Protocols for these studies called for use of aspartame in placebos.
In May, 1992, the Journal of Dental Hygiene (1992) cited Hattan as saying "The FDA's findings were based on the scientific studies provided by the Glutamate Association. The work has been supported by people with an interest in glutamate: consortiums and manufacturers." Earlier, (August, 1990) Hattan had told a toxicology forum in Aspen Colorado that glutamic acid was implicated in a number of disease conditions. According to Hattan, "'developing data on exogenous and endogenous excitogens or excitotoxins has been the primary spur to the Food and Drug Administration's review of monosodium glutamate" (Food Chemical News, 1990). Hattan is central to the debate on the safety/toxicity of MSG, being Deputy Director for the Division of Toxicological Review and Evaluation, at the FDA, and the FDA liaison to FASEB relative to the 1995 FASEB analysis of adverse reactions to monosodium glutamate (MSG). Yet there is no evidence that Hattan raised any question about the propriety of the research being submitted to the FDA by the IGTC as evidence that MSG is safe.
The IGTC has brought badly flawed studies to the FDA for approval, and the FDA has accepted them as demonstrating that the glutamate industry's product is "safe." The FDA has refused to share with either the public, the Congress, or the Court all that it knows about the toxic potential of monosodium glutamate. The FDA has done original research for the benefit of the glutamate industry (Daniels et al, 1995). Thus, the FDA has been actively engaged in the suppression of information pertaining to the toxic potential of monosodium glutamate.
The FDA appears to have cooperated with the glutamate industry at every turn, and has ignored its mandate to protect the public from potentially toxic material. In turn, much of our government has cooperated with the FDA. The flawed nature of the IGTC's research was exposed in 1993 when evidence from the files of the FDA that the IGTC used aspartame in their placebos was brought to the attention of the FDA. In that year, J. Samuels and I asked FDA Commissioner Kessler to investigate the FDA's use of badly flawed studies in their determination that monosodium glutamate is safe. The request was ignored. Even the FDA/HHS Office of the Inspector General, when called upon to investigate charges that the behavior of the FDA was inappropriate, guaranteed that the investigation would be killed by turning the investigation over to the Office of Research Integrity, which, under no circumstances, would have jurisdiction in this matter (C.C. Maddox, Office of the Inspector General, personal communication, March 13,1995). When legislators receive inquiries or calls for help from constituents, they are forwarded to the FDA which, in turn, assures both legislator and constituent that there is no cause for concern.
The FDA is considered an expert in the areas of food, drug, and cosmetic safety by all branches of government; so in any argument over matters of science, the word of the FDA will, with rare exception, be the final word. In addition, the files of the FDA are privileged. Under the provisions of the Administrative Procedures Act, the FDA need disclose to the public, or the Courts, only that information which is part of the Administrative Record for the matter in question; and it is the FDA that determines what the Administrative record for any question shall be.
When challenged in a suit over full and clear labeling of MSG (August 29, 1995), the Court considered nothing but the Administrative Record presented by the FDA. Studies that demonstrated the MSG had toxic potential were not allowed as evidence because they were not submitted to the Court by the FDA as part of its Administrative Record. The Administrative record was made up of material that the FDA needed in order to win its case, plus a smattering of material from the opposition that had no bite to it, but to which the FDA could point and say, "we looked at that." I was a plaintiff in that law suit.
In 1992, the FDA commissioned FASEB to do an independent review of research on the safety (never toxicity) of monosodium glutamate in food. The FDA has admitted, in reports of adverse reactions on file at the FDA, that headache (they don't call it migraine headache) has been reported as an adverse reaction by over 43 per cent of the people reporting reactions to monosodium glutamate. With possible rare exception, monosodium glutamate is acknowledged as a migraine headache trigger by every headache clinic in this country. In 1991, Alfred Scopp published a study entitled "Monosodium glutamate and hydrolyzed vegetable protein induced headache: review and case studies" (Scopp, 1991). But neither Scopp's study nor the subject of migraine headache are discussed in the August 31, 1995 FASEB report (FASEB, 1995).
J. Samuels and I have criticized the 1995 "independent" FASEB study for responding to just those questions posed by the FDA, and ignoring all others; for conflicts of interests of Expert Panel members; for failing to consider all data relevant to the safety/toxicity of monosodium glutamate; for dismissing, or attempting to dismiss, data that did not fit well with a conclusion that monosodium glutamate is safe; for rejecting the FDA's September, 1994 final draft report of FASEB's allegedly independent investigation; for sharing the contents of that September, 1994 final draft report with agents of the glutamate industry--but no one else; and for making the final FASEB report available to glutamate industry agents--but to no one else--prior to distribution.
The FDA claims that the FASEB September, 1994 draft final report was seen by no one outside of the FDA and FASEB. My requests to FASEB, to Hattan, and to Freedom of Information for copies of the report have been ignored, i.e., not even a written statement denying my request has been forthcoming. But when I spoke to Borzelleca in September, 1994 about the inappropriateness of keeping my letter to the editor of Food and Chemical Toxicology from being published, he told me that he had seen a copy of the September, 1994 FASEB draft final report. (This was discussed more fully under "Suppression of Information.")
For years, the FDA has had clear evidence that monosodium glutamate causes brain lesions and neuroendocrine disorders in laboratory animals, and adverse reactions in humans. Moreover, FASEB, in its 1995 report to the FDA, acknowledged that it was inappropriate to use aspartame in placebos used in double-blind studies of the safety of MSG (FASEB, 1995) and the FDA did not dispute FASEB's conclusion. However, the FDA still allows the unregulated use of MSG in processed food, basing its approval on the flawed aspartame-in-the-placebo studies; and refuses even to require that when present in food, its presence be disclosed.
The FDA allows a meaningless distinction to be made between the processed free glutamic acid in the ingredient called "monosodium glutamate" and the processed free glutamic acid in "other hydrolyzed proteins" (Federal Register, 1977). They allowed the words "No added MSG" or "No MSG added" to be used on labels of food that contain MSG (a practice, they say, is no longer sanctioned). They allow the term "natural" to be used in reference to excitatory amino acids. (The FDA definition of "natural" is any product that has its original source in nature.) The FDA allows the glutamate industry to create and use sources of MSG that contain carcinogens (mono and dichloro propanols or heterocyclic amines). The FDA tells people that the free glutamic acid in processed food is identical to the free glutamic acid found in unprocessed food and in higher organisms. In all this, the FDA parrots the words of The Glutamate Association and the IGTC.
The FDA sends out, unsolicited, copies of their bulletins informing physicians and food service providers that MSG is not a potential health hazard; but they won't tell consumers in which ingredients MSG is hidden.
The National Institutes of Health (NIH)
Ties between the NIH and the glutamate industry are not immediately obvious. Review of the literature, however, will demonstrate that the NIH has funded some of the industry-sponsored studies designed to demonstrate that MSG is safe for use in food (Fernstrom, 1996; Goldschmiedt, 1990), and has done limited MSG research of its own (Germano et al., 1991). Review of statements made to the media in support of the safety of MSG will further demonstrate that Metcalfe, of the National Institute of Allergy and Infectious Diseases, has spoken out on the safety of MSG ( Neergaard, 1994).
On May 4-5, 1998, the NIH hosted a conference designed to explore the evidence that the glutamate cascade appears to be associated with several seemingly diverse disease processes of the central nervous system. According to the conference brochure "...the ‘glutamate cascade' appears to be associated with...addiction, stroke, epilepsy, degenerative disorders, brain trauma, neuropathic pain, schizophrenia, anxiety, and depression." The only reference to the role that exogenous free glutamic acid might play came from a member of the audience.
The U.S. Environmental Protection Agency (EPA)
The EPA has only recently become involved with the issue of the safety/toxicity of MSG.
In July of 1998, with time on my hands, I determined to teach myself how to do a keyword search of the Federal Register. The details of my labors are irrelevant, except to say that when I plugged in the key word "glutamate," I discovered that on January 7, 1998, the EPA had approve spraying processed free glutamic acid, used in plant "growth enhancers," on all agricultural products (Federal Register, 1998).
Application to register AuxiGro, the first MSG-containing product to seek registration, had been published in the August 8, 1997 Federal Register (Federal Register, 1997a). Knowing that the product was being offered for sale, I called the EPA pesticide registration department to ask if and when that registration had been granted; and was informed that there was no such product on their computer. Having in hand the EPA registration number being used by the manufacturer, I insisted that the product had been registered. It was finally determined that AuxiGro had been registered on January 14, 1998. But people still call to inform me that they have called the EPA and been told that no such thing as AuxiGro has been registered; and I have not yet seen notice of the registration published in the Federal Register.
On July 14, 1998, J. Samuels wrote to the EPA Freedom of Information office (FOI) to request background material on the approval of glutamic acid spray on agricultural products. The FOI responded in a timely fashion that they could provide no information at this time, because the product had not yet been registered. When I supplied FOI with the product registration number, I was told that as soon as the file had been purged for proprietary information, it would be sent to J. Samuels. But first it had to be retrieved from the office of Edward Allen, who had borrowed it. I was told there was no other copy than that which had been taken by Mr. Allen. On August 26, 1998 I called FOI to determine the status of J. Samuels' FOI request. On August 28, 1998, I called and left a message for Frances Mann and later called, again; at which time Ms. Mann of the FOI office told me she was putting the Request for Registration into the mail. When I pointed out that I had requested the Administrative File, not the Request for Registration, she said she would look into it and get back to me.
On July 13, 1998, J. Samuels wrote to the EPA, alerting the EPA to the fact that a grievous error had been made in approving the use of a neurotoxic amino acid in a spray for use on food. Initial correspondence with the EPA was directed to Lynn Goldman, M.D., Assistant Administrator for Prevention, Pesticides, and Toxic Substances, with a follow-up conversation with her assistant, Douglas Parsons.
Subsequently, a phone call was received from Edward Allen (Regulatory Action Leader, Biopesticides and Pollution Prevention Division (BPPD), Office of Pesticide Programs, EPA; Roy Sjoblad, Ph.D., Branch Chief, Biochemical Branch; and Freshteh Tothrol, Ph.D., (the scientist who reviewed the Auxein applications); who called to assure J. Samuels that the research relating to Auxein's submission had been thoroughly reviewed, and that the product posed no risk to humans. In response to J. Samuels' protestations that the literature clearly indicated that ingestion or other use of free glutamic acid placed both humans and wildlife at risk, Dr. Sjoblad, told J. Samuels that
"We're simply asking you to support the claims you made that. You can do that. You have these claims. We're not aware of it. It's your responsibility..."
By e-mail, J. Samuels immediately submitted 75 references sufficient to demonstrate that ingestion of free glutamic acid places consumers at risk; and followed that, on July 29, with approximately 500 additional citations and abstracts. A more recent letter contained additional information.
Subsequently, J. Samuels received an e-mail from Janet Andersen, Ph.D., Division Director, BPPD, addressed, evidently, to all those who had written to the EPA by that time (J. Andersen (personal communication, July 27, 1998). The short letter contained basic misinformation and misquoted J. Samuels. That letter read, in part,
"The glutamic acid EPA has approved is 99.3% pure (pharmaceutical grade) L-glutamic acid and is NOT MSG (monosodium glutamate). The Auxein Corporation product contains L-glutamic acid and gamma aminobutyric acid. The product does not contain MSG; EPA is aware of the potential for allergic reactions to MSG."
As this is written, I have questions, but no answers, about the activities of the EPA. From the Auxein Corporation's request for glutamic acid: pesticide tolerance exemption, and publication of the Final Rule granting that exemption, I know that either Auxein Corporation did not comply with the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) when making its application, or the EPA failed to publish all of Auxein Corporation's submission when it published the request for exemption and the Final Rule. That fact has been pointed out to the EPA.
I also know, and the EPA has received material, including citations and abstracts of studies that contain the information that: 1) pharmaceutical grade L-glutamic acid was used to destroy retinas, kill brain cells, and cause neuroendocrine disorders before neuroscientists realized that they could accomplish the same effect using an inexpensive food additive called monosodium glutamate; 2) food additive monosodium glutamate, by FDA definition, must contain 78 percent free L-glutamic acid and 21 per cent sodium; and 3) it is the free glutamic acid that occurs as a consequence of manufacture that causes adverse reactions, regardless of the name of the ingredient or product that contains it.
But I do not know why the EPA has ignored the fact that Auxein Corporation violated the FFDCA, has ignored the hard science that says that the free glutamic acid in the Auxein Corporation product has toxic potential, and has said that J. Samuels said "In an email message to EPA on July 23rd, Mr. Samuels has indicated he is not concerned about L-glutamic acid," when J. Samuels never did, and never would, make such a statement. Neither do I know why Andersen responded to a letter from J. Samuels with the answer to one of his many question while ignoring all of the others.
In a letter to J. Samuels dated August 21, 1998, Andersen made the following statements:
1) "There is no scientific evidence that oral consumption of L-glutamic acid normally found in plants and animal proteins causes adverse effects."
The statement is true. It is not the L-glutamic acid normally found in plants and animal proteins that causes brain lesions, neuroendocrine disorders, learning disabilities, and adverse reactions; it is processed free glutamic acid (which consumers refer to as MSG)–the type of glutamic acid found in AuxiGro–that causes those disease conditions.
2) "We have reviewed the scientific studies you sent us showing adverse effects of L-glutamic acid resulting from either direct injection or high-volume force feeding to rodents. None of this data is relevant to the effects of oral ingestion by humans."
Andersen did not respond to the fact that J. Samuels also sent the EPA feeding studies that demonstrated that free glutamic acid caused adverse reactions both in laboratory animals and in humans.
3) "Prior to registering ‘AuxiGro,' the Biopesticides and Pollution Prevention Division (BPPD) in OPP performed a risk characterization on L-glutamic acid as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality protection Act (FQPA)."
Both the references provided to me by the EPA and the statements made in publication of the Final Rule, demonstrate that the EPA has violated Sections 408 (b)(2)(D), 408(c)(2)(A)(i), and 408(c)(2)(B) of the Federal Food, Drug and Cosmetic Act, and ignored Executive Order 13045 entitled Protection of Children from Environmental Health Risks and Safety Risks (62FR 19885, April 23, 1997). Andersen did not address that issue.
According to Section 408 (b)(2)(D) of the Federal Food, Drug and Cosmetic Act, it is the responsibility of the EPA to review the scientific data and other relevant information in support of any action to be taken, and consider its validity, completeness, reliability, and relationship to human risk
According to Section 408 (c)(2)(A)(i) of the Federal Food, Drug and Cosmetic Act, the EPA is allowed to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on food) only if there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. This includes exposure through drinking water.
According to Section 408 (c) (2) (B) of the Federal Food, Drug and Cosmetic Act, in considering an exemption from the requirement of a tolerance, EPA is required to give special consideration to exposure of infants and children.
According to Executive Order 13045 entitled Protection of Children from Environmental Health Risks and Safety Risks, "...each Federal agency: (a) shall make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children."
Approval of the use of free glutamic acid in a spray to be used on agricultural products was based, in part, on 14 toxicological studies published in 1979 or before, either found or referenced in one book published in 1979 on behalf of The Glutamate Association, (Filer, 1997) with no reference to the fact that those studies have long since been refuted, and no consideration of the fact that glutamic acid is a neurotransmitter and a neurotoxin known to cause endocrine disorders later in life when ingested by the young. There were no other toxicological studies from the literature considered.
4) "The amount of L-glutamic acid in the pesticide product ‘AuxiGro,' when used according to the label instructions, results in a final application rate of 0.125 to .75 pounds of product or 0.04 to 0.25 pounds (0.64 to 4 oz) per acre. In addition, the L-glutamic acid is applied three to four weeks prior to harvest. Virtually no residues of L-glutamic acid will remain on the crops at the time of harvest."
Andersen uses the word "virtually." I wonder how she knows. The EPA Final Rule establishing a temporary exemption from the requirement of a tolerance for residues of glutamic acid (Federal Register, 1997b), reads, in part, "...because this amino acid is found naturally in plants, the Agency has determined that residue analysis would not yield meaningful results, i.e., the analysis would not discern whether the glutamic acid source was the plant or the product treatment." No claim is made that there will be no residue. The Final Rule goes on to say, "Residues remaining in or on the raw agricultural commodity after this expiration date will not be considered actionable..." Andersen seems to know something that those who wrote the Final Rule didn't know. Those who wrote the Final Rule establishing a temporary exemption from the requirement of a tolerance for residues of glutamic acid spoke of "residues remaining."
Summary and Conclusions
This paper has described how one giant industry has selectively collected and reported research data in a way that presents its product, monosodium glutamate, in a favorable fashion.
The technique has three basic components. First, there is research that claims to have demonstrated that their product is safe. Procedures used to develop the research, and/or the statistics used to evaluate its results, produce data that will allow researchers to conclude that their product is safe. Few will notice if between abstract and conclusion, in that wasteland of ponderous detail and scientific terminology read only by the most concerned and conscientious scientists, a program of deception has been executed.
Second, there is suppression of information. When contradictory or embarrassing information has been published, those in positions of power block dissemination of that published information. When critiques of deceptive and misleading research reports are offered for publication, those in positions of power refuse to publish the critiques. When, prior to publication, critiques of deceptive and misleading research reports are anticipated, researchers publish their questionable research in journals that do not accept comment following publication; present their findings orally at industry-sponsored or professional meetings; or publish their findings in abstract form, only. Neither oral presentations nor published abstracts are subject to peer review or to published criticism. In no case is it immediately obvious that either data or criticism of data have been suppressed.
Other subtle ways to suppress information involve drawing attention away from the truth, and focusing, instead, on the trivial or untrue. Critics are disparaged or made the subject of jokes. (Critics don't report adverse reactions, they "complain.") Irrelevant information is given in response to serious questions about the safety of a product. ("If you eat too much of anything you'll get sick.") Falsehoods are recited by alleged authorities. ("A blood-brain barrier prevents amino acids that you eat from entering the brain.")
Existing data may be distorted or trivialized. Every report of human suffering is labeled an anecdote and dismissed. Research misconduct, if detected, is excused as error of judgement or sloppy research. Suppression of information, in all of its many forms, is ignored. And those in positions of power to do otherwise, ignore the fact that quantities of badly flawed research and repeated instances of direct suppression of information have contributed to the acceptance of this product. That which has been portrayed here is a system wherein data and other information can be suppressed without accountability.
The third component is the industry's success in convincing those elected or appointed to attend to the welfare of the nation to follow the industry's lead in finding this product to be safe. The FDA, the NIH, and the EPA are the agencies that have been singled out for attention here. But the Department of Agriculture is equally culpable, approving labels of products that say "No MSG," or "No Added MSG," for example, when those products contain MSG in any ingredient except the one called monosodium glutamate. Even the FDA states that such practice is illegal.
This paper has described how Ajinomoto, its corporate friends, and its many agents have convinced others to purchase their product; and have made false representations of matters of fact, by words and by conduct, and by concealment of that which should have been disclosed.
The information presented in this paper is factual. The interpretation is my own. But anyone who takes the time to review the facts with detachment and without the bias of special interests will come to the same conclusions I do. The key to having the system work for those who use it to deceive others is the fact that few, if any, will take the time to review the facts with detachment and without prejudice; and whistle-blowers are punished.
Go to Table 1
Go to Appendices
Go to References
KEEP THIS WEB PAGE ONLINE with YOUR TAX-DEDUCTIBLE CONTRIBUTION TO THE
TRUTH IN LABELING CAMPAIGN
850 DeWitt Place, Suite 20B, Chicago, IL 60611
adandjack@aol.com 858/481-9333 www.truthinlabeling.org
This page was last updated on June 16, 2004.
www.truthinlabeling.org/l-manuscript.html
|
| | Edit |
|
|
|
