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 "...to elaborate and clarify...concern about, "conflict of interest," and..."

February 27, 1993
 
 
 

Life Sciences Research Office
FASEB
9650 Rockville Pike
Bethesda, MD 20814

FDA Docket No. 92N-0391
Dockets Management Branch (HFA-305)
Food and Drug Administration
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857

RE: Analysis of Adverse Reactions to Monosodium Glutamate (MSG) FDA Docket No. 92N-0391
I am writing at this time to elaborate and clarify my understanding of, and concern about, "conflict of interest," and to clarify some of the concepts that need to be understood by anyone claiming the expertise needed to evaluate the safety/toxicity of MSG. Hopefully, the material in this letter will add to your understanding of the complexities of conflict of interest as we know them today, and to your understanding of the need to separate information from misinformation being circulated on the subject of the safety/toxicity of MSG.

I shall try, in the following, to detail my general concerns. They should be openly addressed by every person who shares in the responsibility for passing judgement on the safety/toxicity of manufactured, free glutamic acid (MSG).

HISTORY AND PHILOSOPHY

Because it has been true in the past, I assume that under the terms of the FASEB contract with the FDA that govern the above referenced study, FASEB is not required to disclose--either to the public or to the FDA--information about the staff it uses or the consultants it hires.

I find this arrangement unconscionable. I believe that the American public has the right to know how FASEB and each of its consultants is funded; what funding each has had in the past that might subject them to an obligation--or a perceived obligation--to any special interest group; what special gifts and/or gratuities have been, or will be, accepted from representatives of the glutamate industry and their friends; and what special pressures are placed upon FASEB and each of its consultants by family and friends who function as ancillaries of glutamate industry lobbyists. I have every reason to believe that FASEB staff and special consultants may be both formally and informally "lobbied" on a day to day basis by representatives of special interest groups who are considered friends.

When FASEB was evaluating the safety of amino acids in nutrients and supplements, I asked each of the FASEB consultants for their curriculum vitae so that I might be certain that none of the FASEB consultants would be tainted by conflict of interest. After reviewing the credentials of six of the eight men who sent them to me, I wrote to FASEB expressing concern as follows:

"I have reviewed the materials sent me by the six out of eight consultants who responded to my request for information, and have read some of the published materials of all of them. And I am concerned. There are, among the consultants, one or more who have had benefit of considerable funding from the food and/or drug industries. I do not understand how you can consider a consultant who has considerable and/or recent funding from companies which manufacture food, amino acids used in food, food additives and/or food supplements to be free of conflict of interest. And I am concerned that you can purport to evaluate the safety of neurotoxic amino acids (among others) when you do not have as a consultant a single specialist who deals with the mechanisms of neurotoxic amino acids on a daily basis.
I am not privy to your reasoning in selecting consultants. And I have no knowledge that would suggest that any one of them is less than an honorable man. But when one's bread and butter comes from industry, you can not expect a man to be totally impartial in his evaluation of questions which will affect that industry. Therefore, I would suggest that as you consider the comments of your consultants, and before you accept their recommendations, you review their industry connections and possibly limit or eliminate the input of those who are subject to conflict of interest.

Certainly, if you would like, I can be more specific. But now that I have done what I consider to be my job as self-appointed guardian of the consumer, I would prefer to leave review of the details and the implementation of the remedies up to you. However, if I can be of assistance, please do not hesitate to write or call."

FASEB thanked me politely for the information and said it would be added to the file.

I believe that FASEB has an obligation to disclose how FASEB ascertains that people appointed as consultants have the expertise to understand the scientific literature that they will be called upon to evaluate, and to provide, for public inspection, material to support their contention that consultants have the freedom from conflict of interest necessary to allow them to make an honest evaluation of the materials presented to them.

I believe that the FDA has an obligation to require that FASEB, or any other contractor, ascertain that those people employed as consultants have the expertise and the independence necessary to allow them to make an objective evaluation of the subject for which they have been engaged, and that supporting documentation should be available for public scrutiny.

In 1972, FASEB was chosen to replace the National Academy of Science (NAS) because of "industry representation on NAS panels."(1) At that time, according to FASEB project director Carr, it was stated that FASEB "...will require detailed statements of each member's connections with the food and chemical industries, if any. But unlike the academy, a panelist will be barred from sitting in judgment of a particular food additive if, for instance, companies using or manufacturing the additive have supported his research."(1)

Nice words, but FASEB didn't follow through on them when it did the study on dietary supplements dated July, 1992,(2) and it appears that FASEB has failed to follow through on them again here.

SPECIFIC CONCERNS

I. I am concerned because physicians have been, and continue to be told by the FDA that MSG is safe, and, acting on FDA advice, often choose not to consider that sensitivity to MSG might be a possible diagnosis in cases presented to them.

II. I am concerned because the FDA and many physicians and scientists focus on what they call "Chinese restaurant syndrome" if they consider MSG sensitivity at all, and in so doing ignore the spate of neurotoxic reactions (the asthma, tachycardia, anxiety attacks, hyperactivity and attention deficit disorders in children, etc.,) reported by people who are sensitive to MSG.

III. I am concerned because MSG sensitivity is not well understood by physicians, so even those few who look for it without understanding its complexities often do not find it.

Diagnosis of MSG-sensitivity is difficult for physicians to make because:

1. MSG reactions are induced by a toxic substance, and are not IgE mediated allergic reactions. Therefore the commonly used protocols used to diagnose allergies are inappropriate.

2. MSG reactions are dose related. People do not react to MSG until the amount taken into the body exceeds their particular tolerance levels. Therefore, challenge with a dose that is too small to elicit a reaction in one person could be enough to kill another.

3. MSG reactions exhibit themselves overtly anywhere from immediately upon ingestion to as much as 72 hours later.(3) Therefore, administration of either test or placebo materials in a challenge protocol must be spaced at least 72 hours apart. If examiners fail to space trials appropriately, they risk the hazard of giving a "double dose" of test material or attributing a reaction to administration of a placebo when, in fact, it was a reaction to test material given earlier.

If challenge is to be used to diagnose MSG sensitivity, small doses of MSG must be used initially in order to preclude a violent reaction on the part of a highly sensitive person; and the dosage must be increased over time to well over 5 grams to determine what the tolerance level of any individual might be. Because reactions occur anywhere from immediately to 72 hours after ingestion or use, evaluation of MSG sensitivity could take an extremely long time; and the physician challenging a patient would have to continue the observation period up to 72 hours to determine whether there was, or was not, evidence of MSG-induced sensitivity.

4. The digestion/absorption of MSG is likely quite different from the digestion and metabolism of glutamic acid bound in protein.(4,5,6,7) The former is probably absorbed, at least in part, in the mouth and upper intestines, while absorption/ metabolism of the components of whole protein will not take place above the stomach. Thus capsules are an inappropriate medium for testing sensitivity to MSG.

Quoting from the FASEB study on supplements dated July, 1992, we read that "due to regulatory mechanisms predominantly at the intestinal sites of absorption and metabolism (Monro, 1979) glutamate is found in low concentrations in the plasma relative to amounts found in various other tissues."(2) The inference here is that MSG (manufactured, free glutamic acid) is metabolized just as protein is metabolized. In fact, however, there is evidence (discussed above) that suggests that the digestion and metabolism of free amino acids is quite different from the digestion of protein and the subsequent metabolism of amino acids. Both the sections on Metabolism and Absorption, and Transport in the July, 1992 FASEB study are based on the assumption that digestion and metabolism of manufactured, free glutamic acid is identical to digestion and metabolism of protein.(2)

5. Because MSG is present in practically all manufactured or otherwise processed food, and in many soaps and cosmetics, it is extremely difficult to be certain that subjects of double blind studies have not been exposed to MSG in the meals they take or the cosmetics they use outside of the confines of the study. Inadvertent ingestion of MSG would enhance the effect of test material. It would also enhance the potential for producing a reaction in the response time frame following administration of a placebo.

Diagnosis of MSG-sensitivity is also difficult for the consumer because MSG is hidden in virtually all processed or otherwise manufactured food. Hiding MSG makes recognition of MSG so complex and confusing that people who are sensitive to MSG have a great deal of difficulty realizing it. If an MSG-sensitive person eats something with MSG in it, and has a reaction, he might think at first that he is sensitive to MSG. But if he eats something that does not say "MSG" anywhere on the label and has the same reaction, he will likely conclude that his reaction is to something other than MSG. Not until he recognizes all of the hidden sources of MSG will he be able to make a proper evaluation of what is causing his reaction; and the food industry has seen to it that the hidden sources of MSG change, on what seems to be a daily basis.

Diagnosis is confirmed by the consumer when he is able to confirm, each time after experiencing a reaction, that there was MSG in the food(8) he ingested prior to suffering the reaction. Confirmation is made extremely difficult by the fact that the FDA allows unlabeled MSG to be present in food.

IV. I am concerned that those who study the safety/toxicity of MSG might not understand the difference between free glutamic acid and glutamic acid bound in protein. The distinction is an extremely important one, because MSG-sensitive people are sensitive to free glutamic acid present in products as a consequence of manufacture, and are not sensitive to intact protein or any amount of free glutamic acid associated with unadulterated protein. The confusion is illustrated in the section on L-glutamic acid of the July, 1992 FASEB report which reads, in part:

"Glutamate constitutes approximately 8g/100g protein consumed/day (Table 2)."(2)
This statement is irrelevant to a discussion of MSG, for the subject of the quote is not free glutamate present in products as a consequence of manufacture, but glutamate bound in protein. In addition, the discussion is inappropriate in that it suggests to the uninformed reader that MSG (manufactured, free glutamic acid) is "naturally" present in food in substantial quantity, when the fact is that there is little free glutamate associated with unadulterated protein.

I understand that a number of studies have been undertaken recently to evaluate the amount of free glutamic acid found in a variety of foods. I would expect that representatives of the glutamate industry will use those studies to suggest that there are sizeable amounts of free glutamate occurring "naturally" in food. I detailed my concerns on this subject in a November 9, 1992 letter written to Fred R. Shank, Ph.D., Director, Center for Food Safety and Applied Nutrition, FDA.(9) I explained to Dr. Shank that for an evaluation to be meaningful, the degree to which any tested food has been adulterated during processing must be expressed clearly; and methods used for making the evaluation must be disclosed. I fear that the products evaluated will appear to be unadulterated products, but, in actuality, will be products to which MSG (manufactured, free glutamic acid) has been added, or in which MSG has been produced during the course of manufacture. A copy of the November 9, 1992 letter to Shank is included here as Appendix A.

V. At the present time, it appears that an effort is being made by glutamate industry representatives and their friends to promote the misinformation that sensitivity to MSG is an "allergy," suggesting that anyone who thinks (s)he suffers MSG-induced adverse reactions see his/her allergist for a definitive diagnosis--while knowing full well that MSG-induced adverse reactions are toxic reactions, not allergic reactions and, therefore, will not be identified by any of the commonly used allergy diagnostic tests. The extent to which the medical community accepts this misinformation concerns me.

I am concerned because the American College of Allergy and Immunology (ACAI) distributed a pamphlet coinciding with the "60 Minutes" segment on MSG, supporting the contention of The Glutamate Association, The International Glutamate Committee, and the International Food Information Council, that MSG is "safe." I find it difficult to understand why physicians would have felt it necessary to quell public concern about the toxicity of a neurotoxic amino acid unless it was in response to the lobbying efforts of the glutamate industry.

I also find it difficult to understand how a 16 page booklet distributed by the ACAI called "Advice from Your Allergist" could fail to discuss reactions to neurotoxic amino acids, particularly since the present vogue is for people who claim that they are sensitive to MSG to be referred to allergists. The statement is made that not all adverse reactions to foods are due to allergy. Yet other than a mention that some migraines are provoked by food additives or naturally occurring food chemicals such as monosodium glutamate, there is no mention made of neurotoxic amino acids.

VI. I am concerned because it appears that a concerted effort is being made by industry interests to convince physicians, scientists, dieticians, nutritionists, and laymen that the only appropriate means of diagnosing MSG sensitivity is through double-blind testing--when, in fact, double blind testing as used by glutamate industry representatives is singularly inappropriate for testing for MSG sensitivity, and will most assuredly produce reactions that appear to be produced by a placebo when, in fact, they could be produced by a latent reaction to test material, uncontrolled food consumed outside of the study, or reactive placebo material.(10)

The essential difference between industry sponsored testing and clinical practice where the goal of double-blind testing is to determine the source of the patient's adverse reaction lies in the attitudes of those responsible for the studies, and the fundamental protocols used. In appropriate clinical practice, one or more active ingredients (test materials) may be given along with a single placebo. The placebo is chosen to be a substance to which the patient will probably not react. The clinician uses the placebo as a carrier, i.e, a substance in which to hide the test material. If the patient reacts to the placebo, the clinician knows that the carrier is not neutral for that patient, and the clinician chooses a different carrier. Only when the carrier is neutral can the clinician be certain that a reaction to the test material is a reaction to the test material and not to the carrier.

Glutamate industry studies use different protocols, for here the goal of double-blind testing appears to be to hide the fact that MSG causes adverse reactions. The placebo/carrier is not checked for its potential reactivity, but, instead, seems to be chosen specifically for its reactive character.(11,12)

When neither test material nor placebo causes an adverse reaction, a subject is judged non-sensitive--and rightly so. When both test material and placebo cause adverse reactions, industry representatives tell us that this, too, serves as proof that the reaction to the test material is to something other than the MSG. However, when a subject responds to a placebo, we have no way of judging whether he is sensitive to the placebo or is reacting to the test situation as opposed to something he has ingested. Therefore, the first consideration of an examiner should be to find a placebo to which the subject will not respond. If a subject responds to a placebo, and that placebo is used as a carrier for the test material, we have no way of knowing whether the subject is reacting to both the test material and the placebo or the placebo alone. We know not where the infinite wisdom comes from that enables industry representatives to discern that it is a placebo alone that causes a reaction; for the fact that a placebo causes a reaction would have no bearing on whether or not there was also a reaction caused by MSG. The logic that argues that a subject is not sensitive to MSG if he reacts to a placebo is fallacious.

Only after it has been determined that placebo/carrier material, in and of itself, causes no adverse reaction in a subject, can the examiner consider the question of "placebo effect," i.e., a reaction to the idea of being tested as opposed to a reaction to test material. After it has been demonstrated that a subject does not respond to a given placebo/carrier material, randomized trials within any one of a number of appropriate statistical designs can be used to rule out any true "placebo effect."

Placebos are supposed to be inert materials to which subjects would not respond because of food or chemical sensitivities. Once it has been ascertained that a subject does not respond to the food or chemical properties of a placebo, a response to a placebo is assumed to be a response to the idea of being tested, which truly invalidates his response to test material. If it has not been ascertained that the subject does not respond to the food or chemical properties of a placebo, and the subject responds to it, his response has no meaning.

One of the most interesting abuses of double-blind testing I have come across lately is to be found in studies of the effects of sugar.(13) Sugar, the test material, is given as sugar. The placebo--the supposedly inert, neutral, substance that is used as a placebo--is a neurotoxic amino acid known to cause brain lesions and neuroendocrine disorders in experimental animals, and for which there are over 5,000 complaints of adverse reactions on file at the FDA.

VII. A number of individual consumers have beaten the odds and discovered for themselves that they are sensitive to MSG. Others have read the book In Bad Taste: The MSG Syndrome(14) that exposed some of the hidden sources of MSG, and with the help of that book, and sometimes with the personal help of George Schwartz, M.D., its author, have been able to confirm or disaffirm a sensitivity to MSG.

I am concerned because I have read reports that attempt to discredit self-diagnoses done by consumers. Possibly the finest work in this area has been done by Linda Tollefson, D.V.M., M.P.H., Chief, Adverse Reactions Monitoring System (ARMS), FDA. It is a blatantly biased review of data submitted to the Adverse Reactions Monitoring System by consumers and summarized by Dr. Tollefson with the apparent blessings of FDA Commissioner David A. Kessler. One of Tollefson's reports to the Health Hazards Evaluation Board is included as Appendix B.(15) Tollefson maintains that if a reported reaction could be caused by something other than MSG, MSG can not possibly be the cause of the reaction. The detailed analysis of Tollefson's report (Appendix C)(16) demonstrates the bias inherent in Tollefson's review of data.

VIII. I am concerned that those who consider the safety/toxicity of MSG for FASEB might not understand the basic concepts of testing: the concepts of reliability and validity.

I find no fault with the double-blind study as a valuable diagnostic tool when it is used with appropriate protocols. Similarly, although I have had no experience with the double-blind study as an experimental paradigm, I can see that in certain situations it could have considerable value. However, I am concerned when anyone suggests that double-blind methodology is the standard against which all sensitivity testing needs to be measured; for in actuality, the ultimate standard against which to judge a test is whether or not it predicts or diagnoses an event or condition accurately. I am particularly concerned about the alleged sanctity of the double blind study for the diagnosis of MSG-sensitive people because I have seen the method used with protocols so inappropriate to the stated goals of the studies that I would consider those studies fraudulent. I am concerned because I suspect that in some, if not all, of the double-blind studies related to the safety/toxicity of MSG that are supported by the glutamate industry, protocols have been developed to make certain that they fail to identify people who are sensitive to MSG.

I would remind FASEB and the FDA that when we deal with illness and disease, the bottom line is supposed to be the rehabilitation of the patient or consumer. A test is nothing more or less than a shorthand method for evaluating the condition of the patient; and the criterion for evaluating the usefulness of the test is the degree to which it predicts the outcome it was designed to anticipate.

Never is the criterion for the value of a test another test. The criterion for a test must be its ability to predict reality. This ability to predict reality is called the validity of a test. The reality of MSG-induced adverse reactions is the reality of a person suffering a reaction after ingesting MSG-containing material in the form in which it is ordinarily eaten or otherwise employed.

IX. I am concerned because in the past, FASEB, under contract to the FDA to study the safety of MSG, did not notice that placebo materials used in studies sponsored by the food industry were inappropriate. Classical placebo materials are inert or neutral substances. Materials used in industry sponsored studies were either substances to which a sizeable portion of the population would normally be sensitive or allergic, or were hydrolyzed proteins in the form of flavoring, natural flavoring, bouillon, broth, hydrolyzed vegetable protein, autolyzed yeast, etc., i.e., materials containing MSG but not called "MSG."

I would like to point out that the issue of use of inappropriate placebos was discussed on February 4, 1991 before FASEB relevant to its Evaluation of the Safety of Amino Acids and Related Products.

At that time, Andrew G. Ebert, Executive director of the International Food Additives Council, Chairman of the International Glutamate Technical Committee (IGTC), of which The Glutamate Association is a subsidiary, and Senior Vice President of The Kellen Company, admitted that placebos supplied to researchers by the IGTC contained free amino acids.(17)

Included as Appendix C are copies of correspondence I had with the American Journal of Clinical Nutrition, and Dr. Mark Feldman, co-author of an article entitled "Food coloring and monosodium glutamate: effects on the cephalic phase of gastric acid secretion and gastrin release in humans."(12) In the study, MSG was used as a test material and beef broth was used as a placebo. (In this country, commercial beef broth invariably contains MSG.) The correspondence illustrates my attempt to question the appropriateness of the placebo material, the refusal of the authors and publisher to share my concerns with readers, and the refusal of the authors to provide me with information on the ingredients contained in the placebo.

Mention of the American Journal of Clinical Nutrition brings to mind the fact that their offices are in the same building as FASEB's; and suggests that such proximity might well facilitate informal lobbying.

X. I am concerned because both FASEB and the FDA have not looked carefully at industry sponsored data that purport to find that MSG is "safe." They have not discerned that in most cases the reason that no affect was found due to the use of MSG was because those who conducted the studies looked in the wrong place, at the wrong time, for the wrong thing, and often used subjects who were not sensitive to the low doses of MSG used in the studies.

It had occurred to me that ignoring aspects of a problem that might be embarrassing to the sponsors of a study might be a new trend: don't say anything that is wrong; just focus on something else and fail to mention what you don't want discussed. I rather think, however, that it is just a variation on the old. I have it on good authority that in the 70's, representatives of the glutamate industry visited (or had associates visit) the laboratory of a man who had found that MSG caused brain lesions in experimental animals; that they pretended to replicate his studies; but that they always looked at the wrong time in the wrong place so they could be certain not to find brain lesions.

EXPECTATIONS

I understand that most scientists work in extremely restricted fields. I do not expect that any one of your consultants be an expert in all of the areas that need to be considered. I do, however, expect that FASEB staff will take responsibility for an exhaustive data search and for contacting researchers who do work in related areas, asking for input of both their previous and ongoing research. I would also expect that FASEB would solicit comments from individuals who claim to be MSG-sensitive, particularly in light of the difficulties that many physicians have in making appropriate diagnoses.

I think it appropriate that FASEB actively solicit information of MSG-sensitivity from consumers. I have told a number of acquaintances that FASEB is reviewing the safety of MSG, and some of them have sent me copies of letters they sent to FASEB. FASEB, to my knowledge, has done nothing to encourage and/or facilitate communication from consumers.

I expect each one of your consultants to be open-minded and to be honest in disclosing those assumptions about MSG related areas that they bring to the study.

I expect FASEB to ascertain, and publicly demonstrate, that none of its consultants is subject to conflict of interest.

I find that the FDA's failure to demand full disclosure is unprincipled and inappropriate for a public agency purporting to sponsor objective studies.

The subject of conflict of interest vis-a-vis MSG was addressed repeatedly in the early 1970's by those, like myself, who protested that the study of the safety/toxicity of MSG should be undertaken by persons without food industry ties. You will find enclosed as Appendix E, examples of criticisms of that conflict of interest.(1,18)

I have found that in the past, conflicts of interest were open and blatant. Some of those who served on committees such as this one had clearly received support from food and/or drug companies. But since there has been open criticism of such blatant conflict of interest, I find that the evidence for conflict of interest is of a much more subtle kind; and I would guess that if there were conflict of interest present, it would be of this more subtle nature. I would expect, for example, that "lobbying" would be done indirectly, never by The Glutamate Association or the IGTC. I would expect that long time friends of the person to be lobbied would be approached by representatives of the glutamate industry and be asked to exert pressures on their friend on behalf of the industry. I would expect that institutions, rather than individual scientists, would be given generous grants by representatives of the glutamate industry or friends of the glutamate industry so that there would be no acknowledgement that funds or supplies were provided by industry. An article in the December 8, 1992 Chicago Tribune described the sort of "lobbying" of which I speak.(19) See Appendix F.

I think it appropriate that FASEB review the individual records of the FDA Adverse Reaction Monitoring System (ARMS). ARMS is supposed to record and classify complaints of adverse reactions to a number of products. The ARMS summaries that I have seen, list the complaints made by consumers and conclude that since most, if not all of the adverse reactions reported could be caused by something other than MSG, MSG did not cause the reported adverse reactions.

I know for a fact that Jack Samuels is sensitive to MSG. I also know that ARMS chief Tollefson told Jack Samuels that reports sent to ARMS describing his sensitivity failed to convince her that he was sensitive to MSG. I know other people who have sent complaints to ARMS. I don't know all there is to know about each one of them, but I can not believe that consumers who suffer adverse reactions would eliminate a substance (MSG in this case) from their diets and pretend that they no longer suffered from tachycardia, anxiety attacks, nausea and vomiting, depression, etc., that their children were no longer hyperactive, depressed, suffering from attention deficit disorders, etc., when they were really sensitive to something other than MSG. I can believe, on the other hand, that the ARMS summaries have been developed by an extraordinarily biased individual who serves the interests of the food industry. Therefore, individual submissions to ARMS need to be carefully and completely reviewed.

I have found that certain people are adamant in their insistence that no one is sensitive to MSG--and that some of these people call themselves scientists. I remember phone calls that I made in December of 1989, shortly after I became aware that what I had thought of as my husband's sensitivity to a food additive labeled "monosodium glutamate" was, in fact, a sensitivity to the MSG in all hydrolyzed protein, regardless of whether or not it was identified on a product's label. I called the FDA and the AMA and the ADA and my state university, all in an effort to find someone who could explain the MSG-induced adverse reaction. I remember talking to Richard Cristol of The Glutamate Association, a pleasant, helpful, person, who assured me, over the phone, that my husband could not possibly be sensitive to MSG. I remember talking to Steve Taylor, who many suggested was the foremost authority on the subject of MSG in this country. Taylor was on the faculty of the University of Nebraska and "Communicator" for the Institute of Food Technologists. He was a pleasant, helpful, person who also assured me, over the phone, that my husband could not possibly be sensitive to MSG.

At first I couldn't understand how two clearly intelligent people could be so certain that Jack was not sensitive to MSG. I couldn't understand why these people wanted to convince me that Jack wasn't sensitive to MSG. I didn't know anything about the politics of the food industry then, and it took me a couple of months to learn that both Richard Cristol and Steve Taylor were, directly or indirectly, on the glutamate industry payroll. I would caution FASEB against using any staff or consultants who are adamant in their insistence that few, if any people are sensitive to MSG.

I have written to elaborate and clarify my understanding of, and concern about, "conflict of interest," and to clarify some of the concepts that need to be understood by anyone claiming the expertise to understand the scientific literature that they will be called upon to evaluate in assessing the safety/toxicity of MSG. Hopefully, the material in this letter will add to your understanding of the complexities of conflict of interest as we know them today, and to your understanding of the need to separate information from misinformation being circulated on the subject of the safety/toxicity of MSG.

I look forward to hearing that FASEB has done something with my comments in addition to filing them.

Respectfully submitted,
 

Adrienne Samuels, Ph.D.
1547 Santa Sabina Court
Solana Beach, CA 92075

(619) 481-9333

cc: Bill Clinton
Donna Shalala
David A. Kessler

APPENDICES:

A. November 9, 1992 letter to Shank on the subject of evaluating levels of free glutamic acid in food

B. Report of Linda Tollefson to the Health Hazards Evaluation Board dated September 18, 1989

C. Samuels' critical analysis of Tollefson's report

D. Copies of correspondence between Samuels and the American Journal of Clinical Nutrition and Feldman

E. Criticisms of conflict of interest: Science and the Congressional Record

F. December 8, 1992 Chicago Tribune article "Access equals clout: The blitzing of FDA
 

REFERENCES

1. Gillette, R. Academy food committees: new criticism of industry ties. Science. 1972;177:1172-1175.

2. Life Sciences Research Office, Federation of American Societies for Experimental Biology. Safety of amino acids used as dietary supplements. Prepared for Center for Food Safety and Applied Nutrition, FDA under contract No 223-88-2124 Task Order No. 8. July, 1992.

3. Forty eight hour delayed reactions are not uncommon. Seventy two hour delays have been reported.

4. Zim, H.S. Your Stomach and Digestive Tract New York: William Morrow, 1973.

5. Ward, B.R. The Human Body: Food and Digestion New York: Franklin Watts, 1982.

6. Lynch, J.F., Jr., Lewis, L.M., and Adkins, J.S. (Division of Nutrition, FDA, Washington, D.C. 20204). Monosodium glutamate-induced hyperglycemia in weanling rats. J S Fed Proc 31: 1477, 1971.

7. Kenney, R.A. and Tidball, C.S. Human susceptibility to oral monosodium L-glutamate. Am J Clin Nutr 25: 140-146, 1972.

8. MSG in soaps, cosmetics, chewing gum and cigarettes can also cause adverse reactions.

9. Letter dated November 9, 1992 to Fred R. Shank, Director Center for Food Safety and Applied Nutrition, FDA from Adrienne Samuels.

10. Samuels, A. MSG: a review of the literature and critique of industry sponsored research. July, 1991, Unpublished. (FDA Docket No.92N-0391)

11. Rippere, V. Placebo-controlled tests of chemical food additives: are they valid? Medical Hypotheses 7: 819-823, 1981.

12. Goldschmiedt, M., Redfern, J.S., and 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 51: 794-797, 1990.

13. Roshon, M.S. and Hagen, R.L. Sugar consumption, locomotion, task orientation, and learning in preschool children. J abnormal child psychology. 1989;17:349-357.

14. Schwartz, G. In bad taste: the MSG syndrome. Santa Fe: Health Press, 1988.

15. Memorandum to Marvin Bleiberg, Ph.D., HFF-158 through Chief, Clinical Nutrition Branch, HFF-265 B Yettly from Linda Tollefson, D.V.M., M.P.H., Chief, Clinical Nutrition Assessment Section, FDA, dated September 18, 1989; and report on hypersensitivity-type reactions associated with MSG.

16. Samuels, A. Review to demonstrate bias in Dr. Linda Tollefson's September 18, 1989 review and evaluation of literature on MSG hypersensitivity reactions. December 30, 1990. Unpublished. (FDA Docket No. 90N-0379)

17. Life Sciences Research Office, Federation of American Societies for Experimental Biology. Transcript of the LSRO public meeting held February 4, p 149, 1991.

18. Congressional Record - House. August 24, 1976. Feeding at the company trough. pp 27526-27531.

19. Drew, C., and Tackett, M. Access equals clout: the blitzing of FDA. December 8, 1992. Chicago Tribune.
 

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IF MSG ISN'T HARMFUL, WHY IS IT HIDDEN?