Pseudo-Science?

Read the study by Dr. RG Walton at:

www.dorway.com/peerrev.html

I wanted to get to the heart of the argument that aspartame critics have regarding the scientific research on aspartame, so I went straight to the source: This study is cited repeatedly throughout all the anti-aspartame web sites as "proof" that the scientific research is biased. The claim that ALL non-industry supported research shows aspartame to be dangerous is not supported by the evidence provided in this study, as I see it.

I began by looking at the first 37 of the 92 entries cited as "Non Industry Funded Research" (all 37 are marked "Adverse Reaction Identified"). Please feel free to go directly to MEDLINE to verify that the abstracts reflect my comments. If the studies under question could not be clearly categorized by the abstract, I refer to the complete study.

National Library of Medicine (MEDLINE)

Of the 37 entries, 10 are letters and 3 are reviews. We want to compare research to research. It doesn't take research to write a letter. This leaves 24 valid entries. Note that one of the letters was counted twice (Wurtman, 1983) and another (Blundell JE, et al., 1986) is on the subject of "appetite", which isn't relevant to human safety.

There were 11 experiments or clinical studies with abstracts included. 7 of them do not show obvious harmful effects even though they are marked as "adverse reaction identified". I further examined the complete studies to verify this when necessary. Mishiro Y (1977) is a study on the effect of aspartame on lactic acid in saliva. Yokogoshi (1984,1986) and Coulombe (1986) measure changes in the brain chemistry related to aspartame. Yokogoshi (1984) concludes in the last paragraph of the study, "The significance of our findings in predicting aspartame's effects on humans is unclear." One of the studies (Kiritsy, 1986) shows that aspartame lowers blood pressure. Caballero (1986) is cited, but it is only a measure of changes in plasma amino acids due to aspartame. The authors of this study write, "No serious adverse effects were noted in any of the subjects during the study period." They conclude, "Our data indicate that 10mg/kg doses of aspartame may safely be consumed by persons with hyperphenalalaninemia or PKU who are not on a phenylalanine-restricted diet."

The most interesting one is Drogari (1987): not once in the entire text of the study does the word "aspartame" appear. Does the classification need to be clarified to "adverse reaction TO ASPARTAME identified"?

None of the above studies show negative findings by any reasonable measure of the term.

Of the four experiments that do have negative effects, two are Olney's (1970,1980). These are the often cited experiments that showed that aspartame in large quantities can lead to brain damage in laboratory mice.

The third is Mahalik (1984). It shows damage to mouse neonates following maternal exposure to aspartame. Note that this experiment was duplicated by McAnulty (1989), but the McAnulty experiment showed that aspartame had no negative effects under the similar conditions.

The fourth is Bradstock (1986), which is a review of FDA consumer complaints. The abstract states: "We analyzed 231 consumer complaints associated with the food additive aspartame. Using this method, we found no clear symptom complex that suggests a widespread public health hazard associated with aspartame use; however, we identified some case reports in which the symptoms may be attributable to aspartame in commonly-consumed amounts." Yes, adverse reactions were identified, but only because the entire subject pool was composed of people who complained of these reactions. If we apply this same criteria to a number of the "Industry-Funded" studies, they would also fall under the "adverse reaction identified" category--but that would counter this studies conclusions, wouldn't it?

Of the remaining 14 entries, 5 are in MEDLINE, but do not have abstracts. Three studies (Novick,1985; Kulczycki,1986; Walton, 1986) seem to identify adverse reactions, judging solely by their titles. Brunner (1979) and Grobelny (1985) cannot be judged by their title as to whether they shows aspartame to be harmful.

The remaining 9 entries are not listed in MEDLINE: (Roberts, 1988; Monte, 1984; Koehler, 1986; and 6 citations from the book "Dietary Phenylalanine and Brain Function"). The Monte and Koehler citations do show adverse reactions, according to the summaries emailed to me.

All the citations from the 1988 book seem to be reviews. Roberts is counted three times (from the book twice, and again as a separate citation). It appears all these refer to the same information, the reported reactions to aspartame. Elsas reviews the effects of changes of blood phenalalanine, and Wurtman details the calculations required to compare human to rodent dosages of aspartame. Pinto and Maher review the findings of rodent seizure experiments. Except for the Roberts, none of these should be considered negative findings.

Some Basic Problems with This Study

I. Data Collection

  • It counts letters to the editor as "research". It counts literature reviews as having "adverse reaction identified"--shouldn't the original research be counted, rather than the reviews?

  • The study accuses Nutrasweet of everything that they are guilty of, ie, building a case with false and multiple citations. In the first 37 entries analyzed, there are 10 entries with negative effects, possibly a couple more. The rest are experiments that do not show adverse effects to aspartame (by any reasonable definition), or are letters or reviews. This is based on both the abstracts and an examination of the actual studies. If you scored 10 out of 37 on a test, what would your grade be?

  • A number of studies were found that were not included in either list, and so the data collection is incomplete.

  • In the text comments, the author critiques NutraSweet's listing of research, "Indeed, none of the 24 citations from either FASEB Journal or its predecessor, Federation Proceedings, could be retrieved by an author search in Medline, the largest database of peer reviewed medical journals." as if this were an impropriety. Yet in the listing of "Non Industry-Funded Research" (the inflated "adverse reaction identified" list), look at the year 1988: at least 16 out of 26 of the citations are not listed on MEDLINE. If using studies that don't appear in MEDLINE is okay, why does the author criticize NutraSweet for doing the same thing?

  • Notice the wording to the negative claims. It's labeled, "Adverse reaction identified". This is so broad it can include anything. If a group of subjects in both the placebo and experimental group have reactions, then an "adverse reaction was identified", right? If an experiment on laboratory rats found that seizures (induced by other means) were promoted with aspartame dosages a thousand times above the human equivelant safety level, then an "adverse reaction was identified", correct? From my actual analysis, I found studies that show changes in brain chemistry are marked "adverse reaction identified", even though the researchers themselves make no such claims anywhere within the study.

    II. Method

    One can argue endlessly about how these studies should have be categorized, but this only shows:

  • The criteria for sorting the studies should be clearly stated so that ambiguity is minimized. It should apply to the conclusions stated by the authors, not later subjective readings (since funding will effect their conclusions, not ours).

  • The current categories ("adverse reaction identified" and "safety of aspartame supported") are not logical opposites. It's possible for studies to belong to both or neither category.

  • The current categories represent a false dicotomy: it seems there are only two types of studies, those that support the safety of aspartame, and those that deny it. Clearly there is also an "other" category; studies that neither support nor deny that aspartame is safe.

  • These studies should have been sorted in a blinded fashion, by subjects educated in biochemistry and experimental methods, but who has have no exposure or predefined opinion to the aspartame debate. The sorting should have taken place without their knowledge of the funding source of each study, (or/and) without the knowledge that the studies would be later sorted into categories of funding. No method was stated, but I have I hard time believing this study sorted the research in a blinded fashion.

  • The method of obtaining the funding source information isn't included. "Funding source" is the main measure of this data, and without methodology, it may as well be heresay (ie, the results show aspartame is safe, therefore it was funded by Nutrasweet). Did the researcher of this study personally contact someone listed in the citation? Is it only a reflection of the funding statement in the study?

  • Note that this study hasn't been published in any medical journals.

    Read the citations. Research them. Don't trust me and don't trust them. Judge for yourself.

    Postscript: I am now on the aspartame activist mailing list and in 1999 I engaged in an email debate with Mark Gold (the anti-aspartame 'science' expert) regarding this study. Dr. Walton himself was on the mailing list. He had no response to the criticisms I had of his study. Nor did Dr. H.G. Roberts or Dr. Monte, also on the mailing list. These are three of the top four scientists that believe that aspartame is dangerous.

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