1. selecting MSG insensitive people as study subjects
2. arbitrarily limiting opportunities of these subjects to react with MSG test material
3. using known allergens and toxins as placebos.
4. reducing sample size to avoid significant correlations
5. applying statistical tests that are unmatched with study designs
6. focusing on irrelevant variables
7. ignoring relevant data
TLC summarizes such fraud studies as follows;
TABLE 1*
Glutamate-Industry-Sponsored Human Studies:
Subject Selection and Methodology Favoring Production of Negative Results
| ||||||
Authors
|
Funding sources
|
Bias toward
selecting subjects who might not be sensitive to monosodium glutamate |
Bias toward reducing the likelihood that subjects would react to monosodium glutamate test material
|
Use of toxic or allergenic material in placebos
|
Use of too few subjects
|
Focus on variables irrelevant to production of adverse reactions
|
xxxxxxxxxxxxx
|
xxxxxx
|
xxxxxxxxx
|
xxxxxxx
|
xxxxxxxxx
|
xxxx
|
xxxxxxxxxxxxx
|
Altman DR, Fitzgerald T, Chiaramote LT. (1994)
|
Allerx
IGTC
|
Stipend given
no other information provided
|
Not all reactions were recorded
no other information
|
3 different doses in a liquid vehicle
IGTC placebos contained aspartame at the time
| ||
Bazzano G,
D’Elia JA, Olson RE. (1970) |
Public Health Service
|
Adult males
no other information provided
|
Not all reactions were recorded
no other information
|
Amino acid formula with glutamate as a basic diet
|
11
|
Neurologic function; Hepatic function; Serum cholesterol; Weight
|
Fernstrom JD, Cameron JL, Fernstrom M, McConaha C, Weltzin TE, Kaye WH. (1996)
|
IGTC
NIH
|
Well subjects
Informed consent
|
Beverage1
IGTC placebos contained aspartame at the time.
|
8
|
Plasma glutamate; Change in plasma glutamate; Pituitary hormone secretion.
| |
Geha RS, Beiser A, Ren C, Patterson R, Greenberger PA, Grammer LC, Ditto AM, Harris KE, Shaughnessy MA, YarnoldPR, Corren J, Saxon A. (2000)
|
IGTC
|
Stipend given
Informed consent
|
Used capsules
Not all reactions were recorded
Observation time was inadequate
|
Part 1: ”Citrus- flavored beverage.”2
Part 2: Capsules containing sucrose
IGTC placebos contained aspartame at the time the study was initiated.
|
Reproducible response;3
Pulse; Blood pressure; Respiratory rate;
Relative risk
| |
Germano P, Cohen SG,
Hahn B, Metcalfe DD. (1991) |
no information given
|
13 non-asthmatic and 30 asthmatic adults
|
Not all reactions were recorded
Used capsules
|
no information provided
IGTC placebos contained aspartame at the time
|
13+30
1
| |
Germano P, Cohen SG, Hibbard V, Metcalfe DD. (1993)
|
no information given
|
21 adults with a history of asthma
|
Not all reactions were recorded
Used capsules
|
no information provided
IGTC placebos contained aspartame at the time.
|
21
10
|
.
|
Goldschmiedt M, Redfern JS, Feldman M. (1990)
|
Ajinomoto; NIH; ILSI; VA
|
Well subjects
Informed consent
|
180 mL warm beef consommé soup supplied by Ajinomoto Co., Inc. Tokyo
|
17
15
|
variables were relevant to the study done, but irrelevant to adverse reactions to MSG
| |
Kenney RA. (1979)
Part 1.
|
IGTC (with thanks to NESTEC)
|
Well subjects
Informed consent
|
Test material was given with carbohydrates
Not all reactions were recorded
Observation time was inadequate
|
Tomato juice with common salt.
|
51
16
| |
Kenney RA. (1979)
Part 2.
|
IGTC
|
Informed consent
|
Observation time was inadequate
|
Sucrose; citric acid; trisodium-citrate; lemon flavor; caramel color; naringin.
|
57
16
| |
Kenney, RA. (1986)
|
IGTC
|
no information provided
|
Not all reactions were recorded
|
“...soft-drink solution....”
IGTC placebos contained aspartame at the time.
|
6
|
Objective parameters (routine chemical analyses)
|
Kerr GR, Wu-Lee M, El-Lozy M, McGandy R, Stare FJ. (1979)
|
Ajinomoto USA
|
Randomly drawn stratified random sample
|
Not all reactions were recorded
Observation time was inadequate
|
Questionnaire survey
| ||
Morselli P, Garattini S. (1970)
|
COFAG (IGTC Europe)
|
Well subjects
|
Test material was given with carbohydrates
Observation time was inadequate
|
Beef broth (ingredients not specified) followed by meat, vegetables, and fruit
|
24
|
Blood pressure; Pulse; Respiration rate
|
Prawirohardjono W, Dwiprahasto I, Astuti I, Hadiwandowo S, Kristin E, Muhammad M, Kelly MF. (2000)
|
IGTC
|
Well subjects
Stipend given
Informed consent
|
Small amounts of test material were given with carbohydrates
Used capsules
|
Lactose in gelatin capsules
|
52
|
Blood pressure; Pulse; Respiratory rate
|
Rosenblum L, Bradley J, Coulston F. (1971)
|
no information given
|
Males only
Informed consent
|
Not all reactions were recorded
Observation time was inadequate
|
Diluted chicken stock or diluted chicken stock with sodium (ingredients not specified)
|
95
| |
Schwartzstein RM, Kelleher M, Weinberger WE, Weiss JW, Drazen JM. (1987)
|
IGTC
|
Asthmatics
|
No all reactions were recorded
Used capsules
Medication not given for 12 hours prior to testing
|
Gelatin capsule containing sodium chloride
|
12
| |
Stegink LD, Filer J, Baker GL, Bell EF. (1986)
|
IGTC
|
Informed consent from parent
no other information given
|
Test material was given with carbohydrates
|
Beef consommé supplied by Ajinomoto Co., Tokyo, Japan
|
8
|
Plasma glutamate;
Plasma aspartate |
Stevenson DD, Simon RA, Woessner KM. (1997)
|
IGTC
|
10 alleged CRS-asthmatics and 30 alleged non-CRS asthmatics
Subjects eliminated
|
Not all reactions were recorded
|
no information given
IGTC placebos contained aspartame at the time.
|
10+30
| |
Tanphaichitr V, Srianujata S, Pothisiri P, Sammasut R, Kulapongese S. (1983)
|
IGTC
|
Well subjects
|
Not all reactions were recorded
Test material was given with carbohydrates
|
Four full days’ menus all different, without added monosodium glutamate: this food being able to mask the addition of monosodium glutamate
|
50
|
Plasma glutamate;
Pleasantness or unpleasantness of food |
Tanphaichitr V, Srianujata S, Leelahabul P, Kulapongse S, Patchimasiri S, Pothisiri P. (1985)
|
IGTC
|
Well subjects
|
Not all reactions were recorded
Test material was given with carbohydrates
|
A full days menu without added monosodium glutamate
|
12
| |
Tarasoff L, Kelly MF. (1993)
|
IGTC
|
Well subjects
Stipend given
Informed consent
|
Used capsules
Test material was given with carbohydrates
Not all reaction were recorded
Observation time was inadequate
|
Both beverage and capsules:
Beverage specified as containing aspartame;4 prepared from powders supplied by the IGTC
Placebos in gelatin capsules
|
After-taste; Intensity
| |
Wilkin JK (1986)
|
VA
|
Well subjects
|
Not all reactions were recorded
|
no placebo
|
6
| |
Woessner KM, Simon RA, Stevenson DD (1999)
|
IGTC; Scripps Clinic, Green Hospital & Research Institute
|
30 asthmatics with alleged CRS asthma and 70 without
Informed consent
Subjects eliminated
|
Not all reactions were recorded
Test material was given with carbohydrates
Continued medications
|
5 gelatin capsules containing sucrose
IGTC placebos contained aspartame at the time
|
30+70
30
| |
Yang WH, Drouin MA, Herbert M, Mao Y. (1997)
|
IGTC
|
Well subjects (except subjects with symptoms of CRS were accepted)
Stipend given
Informed consent
|
Not all reactions were recorded
Two or more reactions were required to be counted as a reaction
Observation time was inadequate
|
Strongly citrus tasting beverage containing sucrose supplied by the IGTC
IGTC placebos contained aspartame at the time
.
|
61
36
| |
Zanda G, Franciosi P, TognoinG, Risso M, Standen SM, Morselli PL, Garattini S. (1973)
|
no information given
|
Well subjects
|
Not all reactions were recorded
Observation time was inadequate
Small amounts of test material were given with carbohydrates
|
Beef bouillon (ingredients not specified)
|
72
|
Blood pressure; Pulse rate
|
*Compiled May 1, 2009
Adrienne Samuels, Ph.D.
Adrienne Samuels, Ph.D.
LEGEND
FUNDING SOURCES:COFAG: IGTC EuropeIGTC: International Glutamate Technical Committee (includes manufacturers and users of monosodium glutamate)ILSI: International Life Sciences Institute (often under contract to the glutamate industry)IMC: International Minerals and Chemical CorporationNIH: National Institutes of HealthVA: Veterans AdministrationBIAS IN SELECTING SUBJECTS (Not all people are sensitive to monosodium glutamate at levels ordinarily found in food.)CRS: Chinese Restaurant Syndrome: a limited number of mild and transitory reactions reported in 1968 as being caused by ingestion of monosodium glutamateINFORMED CONSENT, while ethically appropriate, and required of all experiments using human subjects, biases these studies.MALES have been reputed to be less sensitive to MSG than femalesSTIPENDS were given to those who claimed to be sensitive to MSGSUBJECTS were ELIMINATED prior to the study for responding to placebos that were going to be used in the study.WELL SUBJECTS would be persons who had never experienced any of the reactions alleged to be attributable to use of monosodium glutamate (irritable bowel, migraine headache, asthma, skin rash, heart irregularities, mood swings, and depression being possibilities, for example).BIAS TOWARD REDUCING THE LIKELIHOOD THAT SUBJECTS WOULD REACT TO MONOSODIUM GLUTAMATE TEST MATERIALCAPSULES guarantee slow release and, therefore, less effect of the material they containTEST MATERIAL GIVEN WITH CARBOHYDRATES interferes with the uptake of the test materialPLACEBOSIt would appear that in most, if not all, glutamate-industry-sponsored studies, both test and placebo material were supplied by the IGTC. According to a 1991 letter from IGTC chairman Andrew G. Ebert to LSRO-FASEB and the FDA, a “beverage mix designed to mask the taste of [monosodium glutamate]”, was modified in 1978 to replace the [former use of] sucrose with the low calorie sweetener Aspartame. Prior to the time that Northwestern University was alerted to the fact that aspartame was being used in placebo material being used in an IGTC-sponsored study being carried out by Geha et al. at Northwestern, Harvard, and UCLA, the use of aspartame in placebos was not acknowledged in research reports.(1) BEVERAGE: Citric acid, trisodium citrate, lemon flavoring, caramel coloring, naringenin-7-rhamnosidio-glycoside (grapefruit bitter principle), sodium saccharin; prepared by Ajinomoto(2) CITRUS-FLAVORED BEVERAGE: Sodium citrate, citric acid, saccharin, citrus flavor, and naringin were cited as ingredients. Aspartame was used (but not named) with the other ingredients prior to objections filed with Northwestern University by the Truth in Labeling Campaign.(4) BEVERAGE: Sodium citrate dihydrate, citric acid monohydrate, potassium chloride, naringin, grapefruit flavour, caramel, and aspartame.IRRELEVANT VARIABLES(3) REPRODUCIBLE RESPONSE: Repetition of the same two or more responses to monosodium glutamate on two occasions, and no response to the “placebo” (which contained aspartame).
REFERENCES
Altman DR, Fitzgerald T, Chiaramonte LT. Double-blind placebo-controlled challenge (DBPCC) of persons reporting adverse reactions to monosodium glutamate (MSG). J Allergy Clin Immunol. 1994;93:303 (Abstract 844).
Bazzano G, D’Elia JA, Olson RE. Monosodium glutamate: feeding of large amounts in man and gerbils. Science. 1970;169:1208-1209.
Fernstrom JD, Cameron JL, Fernstrom MH, McConaha C, Weltzin TE, Kaye WH. Short-term neuroendocrine effects of a large, oral dose of monosodium glutamate in fasting male subjects. J Clin Endocrinol Metab.1996;81:184-191.
Geha R, Beiser A, Ren C, et al. Multicenter multiphase double blind placebo controlled study to evaluate alleged reactions to monosodium glutamate (MSG). J Allergy Clin Immunol. 2000;106:973-980.
Germano P, Cohen SG, Hahn B, Metcalfe DD. An evaluation of clinical reactions to monosodium glutamate (MSG) in asthmatics using a blinded, placebo-controlled challenge. J Allergy Clin Immunol. 1991;87:177 (Abstract 155).
Germano P, Cohen SG, Hibbard V, Metcalfe DD. Assessment of bronchial hyperactivity by methacholine challenge (MTC) in asthmatics before and after monosodium glutamate (MSG) administration. J Allergy Clin Immunol.1993;91:340 (Abstract 798).
Goldschmiedt M, Redfern JS, Feldman M. Food coloring and monosodium glutamate: effects on the cephalic phase of gastric acid secretion and gastrin release in humans. Am J Clin Nutr. 1990;51:794-797.
Kenney RA. Placebo-controlled studies of human reaction to oral monosodium L-glutamate. In Filer LJ Jr, Garattini S. Kare MR, Reynolds WA, Wurtman RJ, eds. Glutamic acid: advances in biochemistry and physiology. New York: Raven; 1979:363-373.
Kenney RA. The Chinese restaurant syndrome: an anecdote revisited. Food Chem Toxicol. 1986;24:351-354.
Kerr GR, Wu-Lee M, El-Lozy M, McGandy R, Stare FJ. Prevalence of the "Chinese restaurant syndrome." J Am Diet Assoc. 1979;75:29-33.
Morselli P, Garattini S. Monosodium-glutamate and the Chinese restaurant syndrome. Nature. 1970;227:611-612.
Prawirohardjono W, Dwiprahasto I, Astuti I, et al. The administration to Indonesians of monosodium L-glutamate in Indonesian foods; an assessment of adverse reactions in a randomized double-blind, crossover, placebo-controlled study. J Nutr. 2000;130:1074S-1076S.
Rosenblum L, Bradley J, Coulston F. Single and double blind studies with oral monosodium glutamate in man. Toxicol Appl Pharmacol 1971;18:367-373.
Schwartzstein RM, Kelleher M, Weinberger WE, Weiss JW, Drazen JM. Airway effect of monosodium glutamate in subjects with chronic stable asthma. J Asthma. 1987;24:167-172
Stegink LD, Filer J, Baker GL, Bell EF. Plasma glutamate concentrations in 1-year-old infants and adults ingesting monosodium L-glutamate in consommé. Pediatr Res. 1986;20:53-58.
Stevenson DD, Simon RA, Woessner KM. The role of monosodium L-glutamate (MSG) in asthma: does it exist? J Allergy Clin Immunol. 1997;99:S411 (Abstract 1670).
Tanphaichitr V, Srianujata S, Pothisiri P, Sammasut R, Kulapongese S. Postprandial responses to Thai foods with and without added monosodium L-glutamate. Nutr Rep Int. 1983;28:783-792.
Tanphaichitr V, Srianujata S, Leelahabul P, Kulapongse S, Patchimasiri S, Pothisiri P. Effect of monosodium L-glutamate in take on protein-calorie status in healthy Thai adults. Nutr Rep Int. 1985;32:1073-1080.
Tarasoff L, Kelly MF. Monosodium L-glutamate: a double-blind study and review. Food Chem Toxic. 1993;31:1019-1035.
Wilkin JK. Does monosodium glutamate cause flushing (or merely “glutamania”)? J Am Acad Dermatol. 1986;15:225-230.
Woessner KM, Simon RA, Stevenson DD. Monosodium glutamate sensitivity in asthma. J Allergy Clin Immunol. 1999;104:305-310.
Yang WH, Drouin MA, Herbert M, Mao Y. The monosodium glutamate symptom complex: assessment in a double-blind, placebo-controlled, randomized study. J Allergy Clin Immunol. 1997;99:757-762.
Zanda G, Franciosi P, Tognoin G, et al. A double blind study on the effects of monosodium glutamate in man. Biomedicine. 1973;19:202-204.
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