Thursday, August 9, 2018

HOW GLUTAMATE INDUSTRY SCIENTIFICALLY MISLEAD GENERAL PUBLIC?

Truth of Labelling Campaign (TLC), in their blog (http://www.truthinlabeling.org/industrystudies.html), lists a number of methods that are being used by Ajinomoto Co. Inc., largest manufacturer of free glutamic acid and MSG in the world, to deceptively misinform public regarding safety of this popular food additive. These include:

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
Beverage
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;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.
LEGEND
FUNDING SOURCES:
 COFAG: IGTC Europe
 IGTC: 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 Corporation
 NIH: National Institutes of Health
 VA: Veterans Administration
BIAS 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 glutamate
INFORMED 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 females
STIPENDS were given to those who claimed to be sensitive to MSG
SUBJECTS 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 MATERIAL
 CAPSULES guarantee slow release and, therefore, less effect of the material they contain
 TEST MATERIAL GIVEN WITH CARBOHYDRATES interferes with the uptake of the test material
PLACEBOS
It 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. 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 JrGarattini 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. 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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