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At Scripps Clinic and Research Foundation,
(as in many other places)
researchers are required to find funding for their own research
On July 30, 1999, The Asian Wall Street Journal published an article titled "Food for Thought: A Spicy Debate Over MSG Conflicting Claims And Studies Mount, Perplexing Diners," by Robert Templer.
Featured in that article was Ronald Simon, M.D., of Scripps Clinic and Research Foundation, LaJolla, California. Simon joined the ranks of glutamate industry spokespersons in the 1990s, and has been active on their behalf since then. Anyone interested in understanding what Templer called the "Spicy Debate Over MSG," or the badly flawed research Simon turned out at Scripps, should know a few facts about glutamate-industry spokesperson Simon -- including the fact that at Scripps Clinic and Research Foundation, researchers are required to engage in research, and to come up with their own funding..
On August 31, 1995, the Food and Drug Administration (FDA) released a report on the safety of MSG in food, done by the Federation of American Societies for Experimental Biology (FASEB). In that report, FASEB acknowledged that MSG had an effect on some asthmatics, and that doses of MSG as low as .5 grams MSG had been known to trigger MSG reactions. On the day before that top secret report was released to the public, Simon and colleague Dr. Donald D. Stevenson wrote to inform the FDA that they believed that the FASEB report to be released the next day had made a grave error in stating that MSG affected asthmatics. Simon and Stevenson told the FDA that the studies that showed that people reacted to doses of MSG as low as .5 gram MSG had been poorly done. They did not, however, tell the FDA that they had written the letter at the request of someone in the glutamate industry, and that they were contemplating approaching the IGTC for funding, i.e., contemplating doing research that would be funded by the International Glutamate Technical Committee (IGTC), a trade association set up by Ajinomoto, a producer/supplier of a number of amino acids and the world's largest supplier of monosodium glutamate.
Simon and Stevenson also forgot to tell the FDA about their very special relationship with Dr. David Allen, the researcher whose work they criticized in their August 30, 1995 letter to the FDA. In 1991, Simon, with NIH researcher Dean D. Metcalfe, M.D., and Hugh R. Sampson, M.D., had praised the work of Dr. David Allen, who had reported that MSG is an asthma trigger; and they had included Allen's study in their book, Food Allergy: Adverse Reactions to Foods and Food Additives. Indeed, in a letter to a friend, Allen wrote, "Last week my friend Ron Simon from the Scripps Clinic called me and asked me to participate in a symposium at the American Academy of Allergy meeting in San Francisco in March of next year. I will be speaking on sulfites and MSG and their potential to provoke asthma."
There is more. In their July 30 letter to the FDA, Simon and Stevenson claimed to have conducted MSG oral challenges on asthmatic patients who experienced asthma attacks in restaurants between 1980 and 1995, and to have found those patients not to be sensitive to MSG. Then, from their observation of only 25 patients, Simon and Stevenson concluded that MSG does not cause asthma reactions. But given that 25 per cent or more of the population is sensitive to MSG and that approximately 2 per cent of the MSG reactions reported to the FDA Adverse Reactions Monitoring System are asthma reactions, on a straight probability basis, Simon and Stevenson had not tested enough patients to expect even one of them to express an asthma reaction to MSG.
Prior to 1995, Simon had published no study that had the words "monosodium glutamate" or "MSG" in its title. According to their August 30, 1995 letter to the FDA, Simon and Stevenson had done no systematic study, but only observed patients who came to Scripps Clinic for treatment; and they looked for no reactions other than asthma. Further, those 25 patients were given capsules that presumably contained MSG. But ingesting capsules that bypass the mouth, esophagus, and upper intestines before releasing their MSG is far different from ingesting food that contains MSG. MSG in food would trigger taste buds in the tongue and trigger other glutamate receptors known to be present in the mouth; and would pass, as free glutamic acid, into the blood stream in the mouth and esophagus just as other small molecules are know to do. MSG encased in capsules would do none of that.
It's hard to believe that Woessner, Simon, and Stevenson would not know that MSG in capsules would bypass the mouth, esophagus, and upper intestines, slowing MSG's entry into the blood stream. It is also hard to believe that Woessner, Simon, and Stevenson would not have know that there are glutamate receptors in the lungs (Said, S.I., Berisha, H., and Pakbaz, H. NMDA receptors in the lung: activation triggers acute injury that is prevented by NO synthase inhibitor and by VIP. Society for Neuroscience Abstracts 20:1994); and that glutamate encased in capsules would have less chance of entering the lungs than glutamate molecules being inhaled or ingested.
We know even more about the research of Simon and Stevenson. In 1996, Simon and Stevenson initiated research funded by the IGTC. In that year, the newsletter of the NOMSG consumer group reported that when an MSG-sensitive person responded to an advertisement in the Los Angeles Times for test subjects for a new asthma study at Scripps Clinic being conducted by Simon and Stevenson, she was told that "1) if she feared her asthma reactions to be serious that she should not apply for the study; 2) that the person who was screening the applicants didn't believe that MSG could cause asthma reactions; and 3) that this particular person was most likely responding to sulfites, and not to MSG."
In a May 28, 1997 letter, Simon responded to an inquiry I had made asking if their research was being funded by the glutamate industry. "There is no study that we are doing for Ajinomoto or one of their agents, on the general subjective sensitivity to MSG." Simon said in his letter. "The abstract presented at the February 1997 AAAAI meetings was a preliminary report of an ongoing study we designed concerning MSG sensitivity in asthmatics." However, included in the program for that meeting was an abstract for a poster session "The Role of Monosodium L-Glutamate (MSG) in Asthma: Does it Exist?" by Stevenson et al., funded by the IGTC.
We also know that on July 1, 1997, Simon gave Expert Witness testimony on behalf of the defendant in the suit of David Livingston, Plaintiff, versus Marie Callender's Inc., Defendant. In sworn testimony, the same Simon that told Robert Templer that he had designed the research that he did for Ajinomoto, told the Court that he didn't know for sure how much MSG there was in the test material he had used, i.e., didn't know the purity of the chemical, and didn't know what was in the placebos. Simon also told the Court that he wasn't sure where the MSG test material came from, didn't know how much funding he was receiving from the glutamate industry for his 1996 study, didn't know that the glutamate industry was a multi-billion dollar a year industry, did not know who the world's largest producer of MSG is, did not know what IGTC stands for, knew that their subjects were paid for participating in the study, but didn't know how much they were paid, and did not know where the funding for his industry-funded research came from.
Simon told the Court that the placebos used were in the form of gelatin capsules, but he didn't tell the Court that gelatin always contains MSG. He told the Court that asthma medications, which are given to prevent asthma symptoms, were given to subjects, and he couldn't say whether or not they were given during the study. (If given and effective, asthma medications would have prevented asthma symptoms from occurring.) Simon also told the Court that Aspartame and MSG have not been shown to cause similar reactions in asthmatics (which is blatantly untrue). The question of the similarity between aspartame and MSG is relevant because until they were publicly exposed in the late 1990s, the glutamate industry used aspartame in their placebos, thus generating approximately as many responses to placebos as responses to MSG. Simon, not having tested the placebo material provided to him by Ajinomoto, and, evidently, not having asked about their composition, had no idea (said he had no idea) whether or not there was aspartame in the placebos.
The use of capsules is of particular interest. It can not be said too many times that capsules would not stimulate the taste buds or other nerve receptors in the mouth and tongue as MSG in food would; would not stimulate glutamate receptors in the lungs; and capsules would prevent the MSG contained in them from passing into the blood stream from the mouth or esophagus as small molecules, such as the glutamic acid molecule, are known to do.
It's difficult to believe that Simon designed this research of which he knew so little.
Why was Simon solicited by the IGTC? Looking back now, it seems fairly obvious. In 1992, FASEB undertook a study of the safety of MSG in food, responding to 18 questions outlined for FASEB by the FDA. In September of 1994, a final report of that FASEB study was sent to the FDA for the FDA's approval and publication. But there must have been something terribly wrong with the FASEB report, because the September, 1994 final report became the "Draft Final Report," and the "Draft Final Report," was rejected by the FDA -- for "clarification."
What could have been so terribly wrong with the "Draft Final Report?" This author would guess that FASEB could not, or chose not to, cover up the fact that ingestion of MSG places consumers at risk, and that their September, 1994 report reflected their findings. We know for a fact that the "Draft Final Report," was in the hands of the glutamate industry prior to the FDA's call for "clarification." And we suspect that the glutamate industry, finding the report unacceptable, instructed the FDA to reject it. It happened that way in 1978 when FASEB presented a report to the FDA that the glutamate industry found unacceptable. At that time, Ajinomoto and friends convened a symposium in Milan, Italy, submitted the Milan research reports (primarily industry sponsored) to the FDA, and had the 1978 FASEB/FDA report on the safety of MSG rewritten.
There must have been something terribly wrong with the "Draft Final Report," because despite seven Freedom of Information requests and a personal request to FDA Commissioner Jane Henney for a copy of the "Draft Final Report," our requests for a copy of the "Draft Final Report," were ignored. Ignored, that is, until pressure to produce the "Draft Final Report" evidently became too great -- at which time we were told that the Report simply could not be found at the FDA; and that the FDA didn't think that FASEB would have it, either.
Following rejection of the "Draft Final Report," the contract between FASEB and the FDA was rewritten, directing FASEB, through the wording in their new contract, to come up with the conclusion that MSG reactions were not triggered by less than 3 grams MSG. Evidently, faced with growing recognition that MSG is causing adverse reactions in substantial numbers of people; and that the glutamate cascade is implicated in such disease conditions as addiction, stroke, epilepsy, degenerative disorders (Alzheimer's disease, ALS, and Parkinson's disease, for example), brain trauma, neuropathic pain, schizophrenia, anxiety, and depression; the glutamate industry changed its strategy. Instead of having the FDA claim that essentially no one is sensitive to MSG, Ajinomoto and friends would have the FDA claim that essentially no one is sensitive to less than 3 grams MSG per serving. Members of the glutamate industry would be pleased to have to identify MSG in products that contained more than 3 grams MSG per serving because, essentially, there are no such products. But first the research of Dr. David Allen, research demonstrating that subjects reacted with asthma reactions to less than .5 grams MSG, had to be discredited. And who better to discredit Allen's research than Dr. Simon.
The Oh-So-Badly Flawed Woessner, Simon, and Stevenson Study
Of late, the only journals that have published the badly flawed studies sponsored by the International Glutamate Technical Committee (IGTC) have been the Journal of Allergy and Clinical Immunology and the Journal of Nutrition. Their special relationship with the glutamate industry is discussed in an 1999 article published in the peer reviewed journal, Accountability in Research. It should come as no surprise, then, that the Woessner, Simon, and Stevenson study was published in the Journal of Allergy and Clinical Immunology (1999;104:305-310). The last time this author submitted a letter to the editor of the Journal of Allergy and Clinical Immunology, she was told that it would not be published because the authors of the critiques article didn't want it published.
The integrity of the Woessner, Simon, and Stevenson study must be challenged on a number of grounds. First, one must question the lack of integrity in the article's introduction.
--"MSG" say the authors, "is widely available as a chemical in both natural foods and as an additive in many prepared foods..."
But that is 1) not true; and 2) deceptive and misleading. The food additive that causes adverse reactions, including asthma, is glutamic acid that has been freed from protein prior to ingestion. It is fabricated. It is not found in "natural foods" if "natural foods" means food that has not been fermented or otherwise processed. The glutamic acid in truly natural food does not cause asthma reactions or any other MSG reaction.
-- The authors say that "some foods (e.g., tomatoes, Parmesan cheese, and soy sauce) contain naturally high levels of MSG," and they cite a 1979 study by T.Giacometti as evidence.
But as pointed out above, tomatoes do not contain any processed free glutamic acid (MSG), and it follows that any small amount of free glutamic acid that might be found in tomatoes would not cause MSG reactions. Parmesan cheese and soy sauce, on the other hand, could contain substantial amounts of MSG since both are fabricated or processed.
The first deception undertaken by Woessner, Simon, and Stevenson is to confuse a food that would not contain MSG with processed food that would contain MSG. Creating confusion about the source of adverse reactions is a hallmark of glutamate-industry propaganda. The second deception lies in using a 1979 source (Giacometti) for the amount of MSG found in various food -- when that source is no more than a reference to studies done much earlier, at a time when the state-of-the-art methodology of the day would have grossly overstated the amount of free glutamic acid found by analysis. And lastly, the Giacometti paper did not even list soy sauce in any of its many tables.
--You may remember from the text above that Dr. David Allen found that .5 grams MSG triggered an asthma reaction. Yet Woessner, Simon, and Stevenson failed to mention the .5 gram asthma trigger. Independent researchers would not have withheld this information. But those pushing the idea that no one responds to less than 3 grams MSG might very well have done so.
The methodology in Woessner, Simon, and Stevenson study differed substantially from other badly flawed methodology used elsewhere by the IGTC (Samuels, A. Monosodium L-Glutamate: A Double-Blind Study and Review. Letter to the Editor. Food and Chemical Toxicology 1995;33:69-78.). Woessner, Simon, and Stevenson did a single blind study as opposed to the double blind studies done by prior to it, and they restricted their investigation to asthma reactions. However, as in all recent IGTC-sponsored studies, subject selection essentially guaranteed that no selected subject would react to MSG.
1) Subject selection virtually assured glutamate-industry researchers that subjects would not be sensitive to MSG. In this case, because only asthma reactions were being considered, subject selection virtually assured the authors that subjects would not have asthma reactions to either test or placebo material administered to them.
A) Subjects were limited to those who were challenged with placebo trials and failed to react to them with typical asthma reactions. Used by Woessner, Simon, and Stevenson for the first time that we know of, was the very clever ruse of pre-testing subjects for sensitivity to placebos. Given that the placebos were made of gelatin capsules, and assuming that the capsules contained additional reactive material (because placebos used in IGTC-sponsored studies historically have done so), to eliminate any subject who reacted to a placebo would have potentially eliminated any subject who would react to processed free glutamic acid (MSG).
But reactive material was not limited to the placebo material, itself. According to the authors, "A diet low in natural MSG was continued, and no MSG was added to their hospital diet." Interpreting these terms as they would be interpreted by the glutamate industry and by the FDA, we can feel certain that subjects would have been served whatever MSG-laden food Woessner, Simon, and Stevenson prescribed for them, with the restriction that no "monosodium glutamate" be sprinkled on it. Chicken broth made with "monosodium glutamate" and/or other sources of processed free glutamic acid (MSG) would have been acceptable because the chicken broth was part of the hospital diet. There was no "monosodium glutamate" added to the chicken broth that came to the hospital with "monosodium glutamate" and/or other sources of processed free glutamic acid (MSG) in it. Thus, subjects who did not react to the placebos combined with a diet certain to contain processed free glutamic acid (MSG), would not have been sensitive to MSG.
B) Subjects were paid to participate in the study only if they claimed to be extremely sensitive to MSG or to aspirin. I do not know how much they were paid to participate, but in an IGTC-sponsored study done recently at Northwestern University, Harvard, and UCLA, subjects were paid approximately $700 for four hours of participation if they claimed to be sensitive to MSG. There is no evidence that subjects who said they were sensitive to MSG were really sensitive to MSG.
C) This author has seen the account of one rejected subject who reported that she was told that her reactions were so severe that she would not be allowed to participate.
D) Subjects participating in the study had to give informed consent. It is extremely unlikely that a person who knew he or she was sensitive to MSG would volunteer to participate in a study where there would be exposure to having an asthma attack.
2) Subjects who were on medications to prevent asthma attacks were kept on those medications. If the medications were effective, no subject would have had an asthma attack.
There are other areas of concern. The authors told the reader where the monosodium glutamate put into the capsules came from, but did not tell the reader where the capsules themselves came from, what they were made of, and what else went into the capsules besides the monosodium glutamate. There is mention made of red capsules used for test trials, without explanation.
Finally, as has historically been the case,
grand-sounding statistical tests were meaningless. Given that approximately 25
per cent of the population is sensitive to MSG, and that 2 per cent of the 25
per cent suffers asthma reactions following ingestion of MSG, on a straight
probability basis, we would not expect to find more than 1 MSG-induced asthma
reaction in something like 137 people. Woessner,
Simon, and Stevenson did not test 137 people.