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"...Hugh A. Sampson, M.D. and Timothy J. Maher, Ph.D.
lack the freedom from conflict of interest necessary to allow them to make an impartial evaluation of adverse reactions to monosodium glutamate (MSG);
and...FASEB should ask each for his resignation from the ad hoc expert panel."





February 26, 1993
 

Kenneth D. Fisher, Ph.D.
Director
Life Sciences Research Office
FASEB
9650 Rockville Pike
Bethesda, MD 20814

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
Dear Dr. Fisher:

I am writing to you, to both LSRO/FASEB and FDA Docket 92N-0391, and am copying FDA Commissioner David A. Kessler, Health and Human Services Secretary Donna Shalala, and President Clinton because the concerns that I share with you here need to be addressed at this time, not simply filed and forgotten.

I am writing because I believe that Hugh A. Sampson, M.D. and Timothy J. Maher, Ph.D. lack the freedom from conflict of interest necessary to allow them to make an impartial evaluation of adverse reactions to monosodium glutamate (MSG); and that FASEB should ask each for his resignation from the ad hoc expert panel.

In a separate letter dated February 27, 1993, I have outlined 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; and to elaborate and clarify my understanding of, and concern about, "conflict of interest." The material in that letter is relevant to my concerns about Dr. Sampson and Dr. Maher and will add to your understanding of the complexities of conflict of interest as it persists today, and to your understanding of the need to sort out information from misinformation being circulated on the subject of the safety/toxicity of MSG. A copy of that letter is enclosed with this submission.

Please understand that I do not challenge either Dr. Maher or Dr. Sampson on the basis of expertise in their respective fields; for I have seen nothing to suggest that either man has less than outstanding credentials. However, as I read the work of each man, I came across repeated evidence, some of it quite subtle, of close ties to the very industries that would benefit most from a finding that MSG is "safe." I understand that it has been long standing practice to ignore conflict of interest of this sort. However, we think, as President Clinton has suggested, that it is time for a change. Use of scientists to judge what is good for Americans when those scientists have personal or financial interest in the people or companies they might be judging, should be brought to a halt.

I was introduced to the MSG special interest fraternity in late 1989. I had just learned that the Alzheimer's type symptoms that had been exhibited by my husband could be entirely eliminated when he ate nothing that contained manufactured, free glutamic acid (MSG); and that he had been ingesting MSG, to which he knew he was sensitive, on a daily basis because he did not realize that it was hidden in virtually all manufactured or otherwise processed food. My reaction was to research the subject of MSG toxicity and the hidden forms of MSG. I started with the Food and Drug Administration (FDA), my state university, a nutritionist group that I found in the phone book, and the American Dietetic Association (ADA).

Besides referring me to one another, they referred me to the Institute of Food Technologists (IFT), The Glutamate Association, and to Dr. Steve Taylor of the University of Nebraska, referred to as an authority on the subject of MSG. I learned, as I sought help from one after the other, that The Glutamate Association supplied "data" on the safety of MSG to the FDA, and apparently to the IFT; and The Glutamate Association and/or the FDA supplied "data" on the safety of MSG to the ADA, the American Medical Association, the Mayo Clinic, the Berkeley Wellness Letter, the World Health Organization, the European Communities, etc., and people just like me who inquired about the toxic affects of MSG.

Then I learned that The Glutamate Association validated its assertion of the safety of MSG by referring to reports of those to whom The Glutamate Association had provided "data." I also learned that Taylor is both "Communicator" for the IFT on the subject of MSG and paid to represent The Glutamate Association. I searched the literature for research that Taylor had done on the subject of MSG and could find none.

That the "data" provided by The Glutamate Association in an attempt to "prove" that MSG is safe are invalid has been amply demonstrated in a paper entitled MSG: A Review of the Literature and Critique of Industry Sponsored Research dated January, 1991, and on file with this docket.(1) Never-the-less, most of the medical community and much of the scientific community have been taken in by glutamate industry propaganda which has, over the course of the last two decades, been championed by the FDA.

It is not surprising that significant segments of both the medical and scientific communities believe that MSG is safe. However, those whose expertise touches on food sensitivities, adverse reactions to ingested substances, neurotoxicity, and/or neurotoxic amino acids should know the difference between propaganda, fraudulent research, and scientific studies. They should know that:

...the principal ingredient of MSG (L-glutamic acid) is one of three excitotoxic amino acids that cause brain lesions and neurodegenerative disorders in laboratory animals, the other two being aspartic acid, a component of aspartame, and L-cysteine, presently being used as a dough conditioner;
 
...glutamic acid and aspartic acid are analogs;

...adverse reactions to MSG are not allergic reactions but are sensitivities to a neurotoxic substance;

...there are a number of seemingly unrelated adverse reactions to MSG. There are also a number of seemingly unrelated adverse reactions to other neurotropic drugs.

...representatives of the glutamate industry are suggesting that people who think they are sensitive to MSG should see their allergists for confirmation--while knowing full well that traditional tests for IgE mediated reactions will not disclose the non-IgE mediated toxic reaction to MSG;

...diagnosis of MSG-induced adverse reactions is complicated first by the fact that MSG is often hidden in food so that neither the patient nor physician is necessarily aware that the patient has consumed MSG prior to exhibiting a reaction; and second by the fact that the FDA maintains that physicians need not concern themselves with what they call "alleged" MSG-sensitivities because MSG is "safe."(2)

Diagnosis is further complicated by the fact that the only diagnostic tools available to physicians are reports of patients and challenge procedures. Challenge is difficult because tolerance for MSG varies greatly. A dose that one person responds to may cause no reaction in another and kill a third. In addition, lapsed time between administration of test material and onset of an observable reaction ranges from immediate to 72 hours.

...variations in both dose tolerance, and lapsed time between ingestion of MSG and manifestation of reactions, are well understood to be typical of toxic reactions. The variations seen in a salmonella outbreak are a good example of this phenomenon.

...there are at least five areas of the brain that are not protected by a blood brain barrier in either children or adults.
Thus, I find it incomprehensible that a man with Dr. Sampson's credentials could fail to recognize and discuss adverse reactions precipitated by neurotoxic amino acids when discussing food allergies and sensitivities.

I find it incomprehensible that when discussing non-IgE-mediated food hypersensitivities, Sampson and Metcalfe do not mention adverse reactions to either the aspartic acid found in aspartame or the glutamic acid found in MSG.(3)

I find it incomprehensible that when discussing vasoactive substances that may precipitate migraines, Sampson and Metcalfe do not mention either aspartic acid or glutamic acid.(3)

I find it incomprehensible that Sampson and Metcalfe would suggest that the double-blind, placebo-controlled food challenge (DBPCFC) is the "gold standard" for diagnosing food allergies3 without mentioning that without full understanding of neurotoxic sensitivities and the procedures needed to detect them, the DBPCFC would be uniquely inappropriate for diagnosing sensitivity to either aspartame or MSG.

I find it to be more than coincidental that in an August 20, 1992 letter from Andrew G. Ebert to FDA Commissioner Kessler,(4) Ebert stated that "Most recently, IGTC has been cooperating with a number of leading scientists in the development of appropriate protocols using placebo controlled double-blind challenge protocols which clinicians tell us is the only suitable form of this type of study." (The emphasis is mine.) I find it fascinating that "clinicians" have told Ebert that the form of study most appropriate for glutamate industry use is one that, as used by representatives of the glutamate industry, has little or no chance of identifying people sensitive to MSG. (A discussion of inappropriateness of the double-blind study as used by representatives of the glutamate industry to demonstrate that MSG is safe will be found in the body of the enclosed communication dated February 27, 1993.)

I find it incomprehensible that Sampson and Metcalfe would draw attention to a discrepancy between "public perception of the importance of allergic reactions to foods" (approximately 25% of the public perceiving that they have experienced allergic type reactions) and "the prevalence of such reactions identified in clinical studies"3 without suggesting that the unaccounted for reactions may very well be toxic reactions to things like natural food toxins, pesticides, and the neurotoxic amino acids found in aspartame and MSG. Instead, Sampson and Metcalfe tell us only that "the public perception of the importance of allergic reactions to foods substantially exceeds the prevalence of such reactions identified in clinical studies."(3)

It appears to me that Sampson has been influenced by representatives of the glutamate industry and/or their friends. Sampson has had occasion to work closely with Taylor,(5,6) a man who wears many hats, one of which is as spokesman for The Glutamate Association. Sampson has also carried out research sponsored by the NutraSweet Company,(7) a company with significant financial interest in establishing that neurotoxic amino acids can be safely ingested by humans. It is important to understand that NutraSweet is the brand name for aspartame, and aspartame contains aspartic acid--an analog of glutamic acid which is the neurotoxic ingredient in MSG.

For many years, Dr. Maher has had a close working relationship with Richard J. Wurtman, M.D. Both are presently working at MIT, long an institution with a reputation for submitting to industry influence.(8) In late 1991, I had occasion to read a letter written to the FDA by Andrew G. Ebert of the IGTC (parent organization of The Glutamate Association), requesting that he be allowed to bring the FDA new "data" on the safety of MSG.(9) In that letter, Ebert suggested that he would bring data from a study being completed at the Medical College of Virginia, and would also bring a number of scientists with him, one of whom would be Dr. Wurtman. Wurtman has been a long time friend of the glutamate industry. In 1979 he was co-editor of the proceedings of a symposium convened by the glutamate industry for the purpose of producing "data" to submit to FASEB for its 1980 "re-review" of the safety of MSG.(10)

I have looked at some of the research done on the subject of aspartame done by Maher (sometimes with Wurtman). As mentioned previously, aspartic acid, a component of aspartame, is a neurotoxic amino acid and analog of glutamic acid, the reactive component in MSG. In the research that I reviewed, I found that Maher looked carefully at phenylalanine and explored what affects it might be having on a number of variables;(11) but I came across no mention in his work of the potential neurotoxic affects of aspartic acid. Rather, Maher and Wurtman stated that "The aspartic acid [in aspartame] is unlikely to cross the blood-brain barrier..."(11) This statement would seem to be in conflict with a significant body of literature on circumventricular organs and their "leakiness" dating back to at least 1973, that speaks to the fact that there are areas of the brain that are not protected by a blood-brain barrier.

In a 1986 review of neurotoxicology of food additives, Maher laid out a general classification scheme for those substances, but failed to mention the neurotoxic amino acids: glutamic acid, aspartic acid, and L-cysteine.(12)

I perceive in both Sampson and Maher a subtle way of distorting the facts about MSG sensitivity. I do not suggest that there is anything untrue about what the authors say, but there is certainly something fundamentally wrong with what has been left unsaid. This distortion suggests such a critical mind set that it makes little difference whether it is intentional or unintentional. Be it personal bias or conflict of interest, it is an inappropriate mind set for someone who is supposed to be impartially studying the safety/toxicity of MSG. In addition, I have observed that Maher, just like Sampson, has had the benefit of funding by the very industry that would suffer its own adverse reaction if the toxic effects of MSG were acknowledged.(13)

It needs to be stated explicitly that if this committee finds that MSG is unsafe, a strong case can be made for saying that aspartic acid, and thus aspartame, must be considered unsafe, too; not on the basis that some persons are sensitive to phenylalanine, which is common knowledge and for which aspartame presently carries a warning, but on the basis that aspartame contains a neurotoxic substance that has the potential for affecting many more people than are sensitive to phenylalanine. Both Maher and Sampson have benefitted from support provided by those who manufacture and sell aspartame.

In the second letter (enclosed) to which I have referred, I have discussed the history and philosophy of conflict of interest as relevant to the above referenced study and listed specific areas that concern me vis-a-vis both freedom from conflict of interest and the misinformation that any consultant might bring to this study. I believe that those concerns are relevant to the appointments of Sampson and Maher, just as they are relevant to the appointments of any FASEB consultants. They should be openly addressed by each and every person who shares in the responsibility for passing judgement on the safety/toxicity of manufactured, free glutamic acid (MSG) at this time, or any other. Thus they should be openly addressed here, too.

I look forward to hearing that FASEB has considered my comments for use in the future, and has altered the composition of the ad hoc committee.

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
 
 

REFERENCES

1.  Samuels, A. MSG: a review of the literature and critique of industry sponsored research. January, 19, 1991. Unpublished. FDA Docket No. 92N-0391.
2.  Correspondence between Jack Samuels, the American Medical Association, and the FDA.
3.  Sampson, H.A., and Metcalfe, D.D. Food Allergies. JAMA. 1992;268:2840-2844.
4.  Letter dated August 20, 1992 to David A. Kessler, Commissioner, FDA from Andrew G. Ebert, Chairman, International Glutamate Technical Committee.
5.  Taylor, S.L., Bush, R.K., and Nordlee, J.A. Sulfites. In Metcalfe, D.D., Sampson, H.A., and Simon, R.A. Eds. Food allergy adverse reactions to food and food additives. Oxford: Blackwell Scientific Publications, 1991.
6.  Sampson, H.A. Food Allergies and related diseases (a symposium sponsored by the IFT toxicology and safety evaluation division and co-chaired by S.L. Taylor and S.S. Sumner): Food hypersensitivity: Manifestations, diagnosis, and natural history. Food Technology. 1992;46:141-144.
7.  Sampson, H.A. and Cooke, S. The antigenicity and allergenicity of microparticulated proteins: Simplesse. Clinical and Experimental Allergy. 1992;22:963-969.
8.  Congressional Record - House. August 24, 1976. Feeding at the company trough. pp 27526-27531.
9.  Letter dated January 2, 1991 to David A. Kessler, Commissioner, FDA from Andrew G. Ebert, Chairman, International Glutamate Technical Committee.
10.  Filer, L.J., Jr., Garattini, S., Kare, M.R., Reynolds, W.A. and Wurtman, R.J. Eds. Glutamic Acid: Advances in Biochemistry and Physiology New York: Raven Press, 1979.
11.  Maher, T.J. and Wurtman, R.J. Possible neurologic effects of aspartame, a widely used food additive. Environmental Health Perspectives. 1987;75:53-57.
12.  Maher, T.J. Neurotoxicology of food additives. NeuroToxicology. 1986;7:183-196.
13.  Maher, T.J., Glaeser, B.S., and Wurtman, R. J. Diurnal variations in plasma concentrations of basic and neutral amino acids and in red cell concentrations of aspartate and glutamate: effects of dietary protein intake. A J Clin Nutrition. 1984;39: 722-729.
 

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