For More Information GO TO Aspartame (NutraSweet) Toxicity Home Page: http://www.holisticmed.com/aspartame/ 15. Minimum Requirements For High Quality Research One of Monsanto/NutraSweet's first steps in counteracting criticism of the horrendous quality of research they funded is to fund additional poor quality research. As Dr. Wurtman pointed out, they use their influence to derail funding for truely independent research. Most scientists I have talked to about the possibility of conducting independent studies will not consider proposing a study on aspartame because a) full, independent funding for quality research is highly unlikely, and b) it is considered professional suicide in the sense that should the research find adverse reactions to aspartame (as it inevitably does with quality, independent research), Monsanto/NutraSweet will do everything in its power to make the researcher(s) and the results look foolish. Therefore, Monsanto/NutraSweet can now conduct one flawed research project after another virtually unincumbered by the inconvenience of independent researchers obtaining results that conflict with industry "research." In previous chapters we saw how researchers of industry- funded studies prevent their studies from being invalidated by not publishing crucial information and keeping it hidden from the scientific community for years. We also saw how industry researchers were trying to be passed off as "independent" researchers at an aspartame conference. Considering the absurd results from the plasma aspartate measurements, the fact that NutraSweet has refused to provide an independent researcher with their standard aspartame capsules, and the fact that almost all independent research has found problems with aspartame, the question of what was really in those "aspartame-containing" capsules in NutraSweet- and ILSI-funded studies is a major concern. Given all of the years of constant abuses on the scientific method by the aspartame and glutamate industries, it would be ridiculous to, all of a sudden, begin trusting their research even if their was slightly more oversight. With the above-mentioned points in mind, what follows are my suggestions for minimum requirements for high quality research on aspartame. A. Funding & Oversight Given the abuse of science that has occurred since the late 1960s, any involvement of Monsanto/NutraSweet or organizations closely linked to this company (e.g., FDA, American Dietetics Association, American Diabetes Association, Epilepsy Institute, ILSI, IFIC, etc., etc.) automatically disqualifies the research as quality work. Normally, industry involvement does not automatically mean that the research is of poor quality, but in this case, since the abuses were so severe and so frequent, it is clear that the aspartame industry is incapable of conducting research without several well-hidden or not-so-well-hidden flaws. Ideally, funding should come from the U.S. National Institutes of Health (NIH). The amount of funding must be large enough to conduct a quality research project. The NIH should not have any say in the protocol design, however, a truly independent team of experts must be chosen at the NIH to conduct occasional site visits to make sure that the study is being conducted appropriately. B. Researchers One of the most important keys to a quality study will be to have a researcher who has proven his/her independence and knowledge in the area oversee the experiment and protocol design. Dr. John Olney comes to mind as one of the best qualified to provide independence and expertise. The researchers must have demonstrated a complete independence from Monsanto/NutraSweet and related organizations (see above). Close colleagues of researchers with extreme industry bias as was seen in the FASEB (1995) team of experts need not apply. Of course, a background check is not necessary, just common sense in choosing indenpendent experts. The research team must include individuals who have expertise in methanol/formic acid issues, excitotoxic amino acids, phenylalanine, and general knowledge of the sordid history of aspartame research. C. Protocol Design The researchers should accept no input on protocol design from any person or organization linked to the aspartame industry. As long as the researchers are willing to really put aspartame to the test as opposed to continuing Monsanto/NutraSweet's abuse of science, there is no need for them to rely primarily on input from outside organizations. D. Test Product & Administration i. Capsules or Real-World The strong preference is to use real-world, aspartame- containing products. If the experiment is simply to test biochemical changes over time, a double-blind protocol may not be necessary. In that case, capsules should not be used. In order to use real-world products in a double- blind experiment, a taste mask must be created. This means that preliminary biochemical experiments need to be conducted to be absolutely certain that the taste mask has no significant effect on the biochemical measurements (e.g., methanol, formate, aspartate, phenylalanine/LNAA, DKP, prolactin, luteinizing hormone, etc.) which might occur after real-world aspartame product administration. Any taste mask that is recommended by industry should be immediately suspect, but not automatically discarded. ii. Dosage If real-world products are used, they should be given to the subject at a level of approximately the current FDA Acceptable Daily Intake limit of 50 mg/kg/day. If capsules are used, they should be given to the subject at a dosage of 100 mg/kg/day since the capsules will reduce the biochemical changes significantly. iii. Administration The test product should not be given with meals except for in experiments which allow the subject to ingest real-world products at any time they wish throughout the day. Experiments focusing on aspartame administration with carbohydrate-containing products in order to add to the effect of the phenylalanine part of aspartame or with MSG to enhance the excitotoxic effects can and should be conducted at a later date. iv. Obtaining Test Product If real-world products are used, the researchers should try to use a wide variety of products, focusing primarily on liquid, aspartame-containing products such as diet sodas that have been stored at room temperature or above for at least two months. Also, baked goods and heated mixtures should be used as well. The products should be purchased from retailers and ideally at different locations around the region and then kept in storage at or above room temperature. Spot testing of test products using quality HPLC techniques should be done. If encapsulated aspartame products are used, it would be preferable to add 10 mg/kg of DKP and a small amount of beta-aspartame to the powder. The encapsulated substance should ideally be obtain from an independent source as opposed to from NutraSweet. If it is obtained from NutraSweet, it should be obtained as powder, not in capsules, and every batch of aspartame, DKP, and beta- aspartame should be very carefully checked using HPLC for anyunexpected chemicals. If the aspartame, DKP, and beta-aspartame are obtain independently, spot checks should be performed using HPLC to assure purity. Capsule material must be obtained independently and should be spot-checked for purity using HPLC. The capsules should be of a variety that quickly dissolves once in the stomach. The test products should be kept in a very secure location to prevent tampering. E. Length of Test Ideally, a double-blind test for adverse reactions caused by aspartame should be at least one year long, preferably two years long. Since we are expecting that aspartame will be used for a lifetime, it is not unreasonable to test for at least a year. Even a test of cigarette smoking for a year would not likely turn up many cases of lung cancer. A six month test would be the absolute minimum required for a reasonable quality test of aspartame. But we have to understand that it is very unlikely that many of the more serious adverse reactions to aspartame would occur within six months of the initial ingestion of aspartame. F. Subjects Since it is nearly impossible to conduct a study which is long enough to produce the very serious adverse reactions that are often seen in the general population upon regular, long-term consumption of aspartame-containing products, initial, high-quality tests should be first done on vulnerable populations. As discussed earlier, PKU heterozygotes are not an extremely vulnerable population. It would be appropriate to first conduct the test on persons with Chronic Fatigue Syndrome, Fibromyalgia, Chronic Depression, and Mutiple Chemical Sensitivities. There are, of course, many vulnerable populations, but these four vulnerable populations would be a good start. Inappropriate exclusion criteria which is quite common in industry studies should not be used in a high-quality, independent study. A representative sample of the test population should be used. Since all people except persons with PKU are told that aspartame is "safe" for them, persons with histories of serious illnesses should not be excluded. Women of childbearing age should also not be excluded, obviously. The larger the test group, the better. Eightly subjects would be ideal, but forty would also be acceptable. G. Biochemical Tests In an independent study, the researchers should actively look for biochemical changes that may cause or contribute to adverse reactions from short-term and/or long-term use. Not only does this mean taking standard measurements (e.g., aspartate, phenylalanine/LNAA, methanol, formaldehyde, formate, prolactin, luteinizing hormone, DKP) at appropriate times using appropriate, accurate and sensitive measuring techniques, but also looking in places that are not obvious such as CSF measurements for various biochemical changes (shortly after aspartame administration and long-term changes), effects on glutamate receptors (if possible) both in the hypothalamus and peripheral glutamate receptors, changes in others amino acid levels, changes in immune system response or other changes which may occur from formaldehyde exposure, and any other possible changes that the experienced researchers might think could lead to adverse health consequences. H. Location Research should be conducted at laboratories or universities that are not influenced by Monsanto/NutraSweet or International Technical Glutamate Committee (ITGC) funding, funding from food companies using aspartame or MSG, or funding from organizations which receive money from Monsanto/NutraSweet or the ITGC. Common sites for NutraSweet- funded "research" should not be used under any circumstances. I. Preliminary Results It would be preferable if preliminary data was forwarded to an independent accounting organization, the Aspartame Consumer Safety Network, the funding organization, and the NutraSweet Company every few months. In this way, should the experiment or the publication of the results get sidetracked (due to political pressure, for example), at least some data will have been obtained by the concerned organizations. J. Publication It is important that as many individual measurements be shown as possible in the publication. In addition, the display of data should be sensible (e.g., not based on averages for each time period), and appropriate statistical techniques should be used (e.g., not splitting adverse reactions up into 50 different categories to avoid statistical significance). The results of the research should be published in a timely manner and the slant of the text should not be unduly influenced by the journal editor.