In summary, the quality and type of evidence obtained by a passive surveillance system based on consumer complaints are or are not possible under these circumstances to provide a basic descriptive analysis of the demographic characteristics of the complainants revealed that the great majority were white woman 20-60 years of age. This over representation of women may reflect a greater use of aspartame-containing products, a greater tendency to report their symptoms, or a greater susceptibility to side effects from aspartame. Available data are not adequate to resolve this issue.
A wide variety of symptoms was reported. No specific constellation of symptoms was identified in relation to aspartame ingestion; however, a substantial number (25-30 percent) of individual complainants reported that their symptoms recurred after repeated consumption of aspartame-containing products without evidence of misuse or other alternative explanation. How
many of the individuals who reported repeated episodes of symptoms after aspartame use had symptoms that were due to aspartame, we cannot determine. Whether the symptoms experienced by persons who chose not to use aspartame again were caused be aspartame is also not clear. In a few instances persons who had challenged themselves several times with aspartame-containing products found by the time of our re interview that their symptoms were, in fact, not due to aspartame. These individuals had used aspartame without such symptoms subsequently or had come to alternative explanations for their symptoms. This, this investigation of consumer complaints of symptoms experienced after consumption of aspartame-containing products has identified no specific individual
symptoms were reported with greater frequency that other symptoms, and 28 percent of individual complainants reported experiencing repeated episodes of symptoms after aspartame use. While some of these reports are undoubtedly due to mere coincidental occurrences of symptoms after aspartmae consumption, and others may be due to the suggestibility of some persons, still others may be attributed to some as yet undefined sensibility to aspartame in commonly consumed amounts. The only way that these possibilities could be thoroughly evaluated would be through focused
clinical studies.
APPENDIX
CASES REVIEWED FOR DEMOGRAPHIC AND SYMPTOM-SPECIFIC INFORMATION ONLY
Introduction
The first 231 completed questionnaires received at CDC were coded for intensive computer analysis. The following results are based on the remaining 286 questionnaires, which were coded for demographic and symptom-specific data only, for the purpose of assessing comparability with
the first 231.
Consumer complaints originally submitted to the FDA and to G.D. Searle and Company made up the bulk of the cases examined in this report (Appendix Table 5). The FDA received 110 reports; G. D. Searle and Company received 92 reports. Dr. Woodrow C. Monte, Director, Food Science and Nutrition
Laboratory, Arizona State University, Temple, Arizona, provided 50 consumer complaints that had been originally submitted to him. Also included in this group were 31 additional complaints that had been submitted to the State of Arizona. The remaining three reports came from Mr. James C. Turner,
Counselor, Community Nutrition institute, Washington, DC.
Summary of Results and Discussion
Overall, the demographic distribution of these cases was similar to
the first 231 cases reviewed at CDC. Once again, the complainants were
predominantly female (76 percent) (Appendix Table 1) and white (97 percent)
(Appendix Table 20, with the majority being between the ages of 21 and 60
years (Appendix Table 3).
The distribution of complainant’s States of residence did, however,
differ from the initial analysis. Reports were again reviewed from many
different States; in this case, 23 percent were received from Arizona.
Forty-six percent of these 67 Arizona cases were included n reports that
the FDA solicited from Dr. Monte.* The increased number of complaints
received from residents of Arizona is most likely attributable to the
publicity in Arizona surrounding the concerns raised there by Dr. Monte. It
is also likely that many of the other complainants residing in Arizona were
aware of Dr. Monte’s concerns and were thus encouraged to submit complaints
to the FDA, G.D. Searle and Company, or to the Arizona State Health
Department.
For both the initial 231 cases and the subsequent 286, there were
relatively few cases reported until the summer of 1983 (Appendix Table 6).
In the analysis of the first 231 cases, there were fewer reports during the
fall of 1983 and then another peak of reports in the winter of 1983-84. In
the analysis of the subsequent 286 cases, reporting did not decrease during
the fall of 1983, but continued through the winter of 1983-84. This
apparent difference in reporting rates in the fall of 1983 is most likely
due to the instructions that the field investigators received to
concentrate initially on the most recent reports in order to maximize
recall by the complainants. According to these instructions, the complaints
received in the winter of 1983-84 would have been re interviewed prior to
those in the fall, thus giving the appearance of a lowered reporting during
the fall of 1983.
The distribution of symptoms reported between the first 231 cases and
the remaining 286 cases was similar (Appendix Table 7). The most frequently
reported symptoms were in the neurological/behavioral and GI categories. In
the neurological/behavioral category, headaches and mood alterations were
again the most frequently reported symptoms (Appendix Table 8). In the
analysis of the 286 cases, mood alterations were more frequently reported
that headaches; but the difference is not large, and mood alterations is a
category that includes a number of different symptoms, while headaches is a
single symptom.
The GI allergic symptom categories were reported with similar
frequency in the later analysis, and the distribution of symptoms reported
was also similar to the first 231 (Appendix Table 9 and 10). Slightly more
GI complaints also were accompanied by neurological/behavioral complaints;
however, as discussed in the preceding paragraph, the
neurological/behavioral complaints did not appear to differ significantly
from the initial 231.
One death involving a worker in a G. D. Searle and Company plant was
reported to be among the 286 cases. |The clinical history has been reviewed
by the FDA, and it was not felt that there was any indication that this
death was associated with aspartame ingestion. Details were available in
the case report V-0656 included in this Appendix on page 145.
Then, a small number of symptoms was reported in the analysis of the
286 cases that were not reported in the earlier analysis; the frequency of
such reports, however, was very low (Appendix Table 12). No previously
unrecognized category of complaint emerged in the later analysis in
sufficient numbers to warrant concern that the initial analysis had not
picked up a neurological/behavioral symptom complex present in the total
population of complainants. Overall, the demographic characteristics and
distribution of symptoms in the 286 cases analyzed in this section of the
report were very similar to the initial 231 cases that were analyzed in
depth. The comparative review did not indicate any bases for concern that
the initial 231 cases were likely to be unrepresentative of the overall
group of reported symptoms.
CASES REVIEWED FOR DEMOGRAPHIC INFORMATION: TABLES
Appendix Table 1
Sex Distribution of Remaining Cases
Compared with Initial Cases Selected for In-Depth Review
Remaining Cases Cases Selected for Review Sex
Percent Percent
Male 24 25
Female 76 75
TOTAL 100 100
Appendix Table 2
Race Distribution of Remaining Cases
Compared with Initial Cases Selected for In-Depth review
Remaining Cases Cases Selected for Review Race
Percent Percent
White 97 94
All Other 2 3
Unknown 1 3
TOTAL 100 100
Appendix Table 3
Age Distribution of Remaining Cases
Compared with Initial Cases Selected for In-Depth Review
Remaining Cases Cases Selected for Review Age
Percent Percent
<20 22 18
31-40 26 26
41-50 17 20
51-60 17 13
61 + 9 11
Unknown 0 2
TOTAL 101 99
Appendix Table 4
Distribution of Remaining Cases
Compared with Initial Cases Selected for In-Depth Review By State of Residence
Remaining Cases Cases Selected for Review State
Percent Percent
AK <1 0
AL <1 1
AZ 23 2
CA 14 11
CO 2 2
CT 4 2
DC <1 <1
DE <1 0
FL 3 3
GA 1 <1
IL 3 5
IN 1 3
KS 0 1
KY 0 1
LA 1 0
MA 5 3
MD 4 4
ME <1 0
MI 2 6
MN 1 1
MO <1 0
MS 0 3
NC 2 3
NE <1 <1
NH 0 1
NJ 1 5
NV <1 0
NY 6 15
OH 4 5
OK 1 1
OR 1 0
PA 4 6
RI <1 <1
SD <1 0
TX 4 3
VA 1 3
VT <1 0
WA 3 <1
WI <1 3
WV <1 <1
WY 1 0
Appendix Table 5
Distribution of Remaining Cases
Compared with initial Cases Selected for In-Depth Review By
Agency/individual Receiving Report
Remaining Cases Cases Selected for Review
Agency/Individual Percent Percent
FDA 39 54
G.D. Searle and Company 32 39
Woodrow C. Monte 17 6
Arizona Health Dept. 11 0
James C. Turner 1 1
TOTAL 100 100
Appendix Table 6
Distribution of Remaining Cases by Date of Symptom Onset Compared with
Initial Cases Selected for In-Depth Review
Remaining Cases Cases Selected for Review
Percent Percent
1982
June 1 0
July/August 2 3
Sept/Oct 2 1
Nov/Dec 1 3
1983
Jan/Feb 6 6
Mar/Apr 5 6
May/Jun 10 9
Jul/Aug 15 23
Sep/Oct 16 15
Nov/Dec 16 10
1984
Jan/Feb 18 16
Mar/Apr 3 3
Unknown* 4 4
TOTAL 99 99
*Includes seven complaints in which the complainants was unsure of data of
onset; estimated dates indicate time when aspartame was not generally
available.
Percent (%) may not total 100 due to rounding.
Appendix Table 7
Distribution of Remaining Cases
Compared with Initial Cases Selected for In-Depth Review By Major Categories
Remaining Cases Cases Selected for review Symptoms
Category Percent Percent
Neurological/Behavioral 54 51
Neurological/Behavioral
+ Gastrointestinal 14 8
Neurological/Behavioral
+ Allergic 5 4
Neurological/Behavioral
+ Menstrual 5 3
Gastrointestinal Only 11 16
Gastrointestinal
+ Allergic 1 <1
Allergic Only 7 16
Menstrual Only 2 3
Neurological/Behavioral
+ Gastrointestinal
+ Allergic 1 0
Neurological/Behavioral
+ Gastrointestinal
+ Menstrual 1 0
TOTAL 101 101
Excludes 32 cases reviewed for demographic data only.
Excludes 15 cases with complaints in non-major categories only.
Percent (%) may not total 100 due to rounding.
Appendix Table 8
Distribution of Remaining Cases
By Neurological/Behavioral Symptoms
Symptoms Percent Number
Mood Alterations 24 104
Headache 20 88
Dizziness 15 63
Insomnia 7 31
Fatigue 7 30
Visual Impairment 6 26
Memory Loss 4 16
Seizures/Pre-Seizures 3 12
Numbness 2 9
Fainting 2 9
Disorientation 2 9
Hallucinations/Pre-hallucinations 1 6
Lack of Concentration 1 6
Hyperactivity 1 5
Motor Dysfunction 1 5
Auditory Disturbances 1 3
Ringing In Ears <1 2
Loss of Balance <1 1
Sleepwalking <1 1
Speech Impairment <1 1
Rush to Forehead <1 1
Paranoia <1 1
Nightmares <1 1
Behavioral Changes <1 1
Personality Change <1 1
Loss of Sense of Taste <1 1
Drowsiness/Listlessness 0 0
TOTAL NEUROLOGICAL/BEHAVIORAL SYMPTOMS 433
Mood Alterations:
Agitation
Anxiety
Depression
Hysteria
Irritation
Nervousness
“Spaced-out”
Suicidal
Violent
For comparison with neurological/behavioral cases selected for in-depth
review. see Table 6-3, page 40.
Appendix Table 9
Distribution of Remaining Cases
By Gastrointestinal Symptoms
Symptoms Percent Number
Nausea 35 38
Diarrhea 22 24
Abdominal Pain 19 21
Other GI Symptoms* 11 12
TOTAL GI SYMPTOMS 100 109
*Other GI Symptoms:
Symptom Number
Bloated feeling 4
Gas 3
Activated preexisting colitis 1
Hiatial hernia 1
Pancreatitis 1
Burning in GI tract 1
Soreness in rectal area 1
Indigestion 1
Constipation 1
Total, Other GI 14
For comparison with gastrointestinal cases selected for in-depth review,
see Table 8-3, page 103.
Appendix Table 10
Distribution of Remaining Cases*
By Allergic Symptoms
Symtoms Percent Number
Sore Throat/Mouth 29 13
Rash 24 11
Itching 16 7
Anaphylactic Reaction 2 1
Other Allergic Symptoms 29 13
TOTAL ALLERGIC SYMPTOMS 100 45
Other Allergic Symptoms
Symptom Number
Flushing 2
Swelling in toes 1
Choking and gasping for air 1
Constricted throat 1
Welts on bottom of feet 1
Welts on entire body 1
Shallow breathing 1
Pain in eyeballs 1
Sinus pain between nose and right eye 1
Facial swelling 1
Burning sensation in upper right arm 1
Burning in esophagus 1
Total, Other Allergic 13
For comparison with allergic cases selected for in-depth review, see Table
7-3, page 84.
Appendix Table 11
Distribution of Remaining Cases
By Menstrual Symptoms
Symptoms Percent Number
Irregular Menses 37 11
Increased Menstrual Flow 13 4
Decreased Menstrual Flow 13 4
Menstrual Spotting 0 0
Premature Menses 7 2
Late Menses 7 2
Other Menstrual Sys 23 7
TOTAL 100 30
Other Menstrual Symptoms
Symptom Number
Painful menstrual periods 3
Spotting between periods 2
Vaginal bleeding 1
Continuous bleeding 1
Total 7
Appendix Table 12
Distribution of Remaining Cases
By Miscellaneous Symptoms
Symptoms Number
Painful Joints 11
Flu-like symptoms 8
Palpitations/racing heart 3
Chills/sweats 5
Sleepiness 4
Bladder Dysfunction 3
Fever 3
Shortness of breath 3
Loss of breath 3
Coughing 3
Pressure in chest 2
Pressure in head 2
Increased appetite 2
Premature ventricular contractions 2
Pain in chest 2
Rise in blood glucose level 2
Loss of appetite 2
Strong odor in urine 2
Blood in urine 2
Urinary urge on awakening 1
Frequent urination 1
Extreme thirst 1
Swelling of ankles 1
Swelling in both hands 1
Rigid and stiff 1
Blackouts 1
Heart pain 1
Cramps on left side of body 1
Loss of strength 1
Numerous colds & infections 1
Back pain 1
Non-malignant tumor 1
Drop in blood pressure 1
Sensitivity to light 1
Hair growing on face (female) 1
Teeth crumbling 1
Unusual taste in mouth 1
Insulin shock 1
Charley horses 1
Cardiac arrest 1
Gray/black bar in left eye 1
Chipping of fingernails 1
Bitter taste 1
Earache 1
Lump in hip area 1
Rapid breathing 1
Left eye pain 1
CASE REPORT: CASES REVIEWED FOR DEMOGRAPHIC INFORMATION ONLY
V-0656: Acute Myocardial Failure, Group D
This is a complicated case of a 21-year-old white male worker in an
aspartmae production facility who died of acute myocardial failure. It was
reported by his stepfather and interviews were conducted with the mother,
wife, stepfather, and physicians of the deceased, as well as with the
medical examiner who performed the postmortem examination.
The case subject was an apparently healthy heavy smoker and
occasionally heavy user of alcoholic beverages who developed in August 1981
severe right-sided chest pain for which he was hospitalized. No definite
diagnosis was made; however, it appeared from an EKG taken at the time that
he had some preexisting heart disease with a contraction defect (junctional
PVC, LVH by voltage criteria, bradycardia, and relatively increased QT and
decreased PR intervals.) Subsequently, he began working with aspartame in
large amounts and consumed aspartame-containing products. He intermittently
had chest pains, dizziness, blurred vision, and hot flashes; in October of
1982, he collapsed at home with cardiac arrest associated with ventricular
fibrillation. He developed a transient anoxic encephalopathy and was found
to have a dilated cardiomyopathy with chronic ventricular ectopic activity
and an anomalous origin of the left circumflex artery. He was followed
medically and maintained on quinidine sulfate. IN May of 1983, he was
involved in an industry accident, which resulted in the loss of his left
arm. He was reported to then have developed intermittent chest pains,
memory loss, and the onset of migraine headaches and muscular-skeletal
pains. He died in March 1984 while sleeping. Post-mortem examination
diagnosed myocardial hypertrophy and dilation, congenital anomaly of the
left interior descending artery, and a myocardiopathy possibly related to
viral endocarditis. Evidence that exposure to aspartmae caused or
aggravated his symptoms or his heart disease could not be established by
interview with physicians in attendance, with the medical examiner, or from
review of case records.
BIBLIOGRAPHY
1. Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR. An algorithm for
the operational assessment of adverse drug reactions. I. Background,
description, and instructions for use. JAMA 1979;242:623-632.
2. Hutchinsob TA, Leventhal JM, Kramer MS, Karch FE, Lipman AG, Feinstein
AR. An algorithm for the operational assessment of adverse drug reactions.
II. Demonstration of reproducibility and validity. JAMA 1979;242:633-638.
3. Visek WJ, Chronic ingestion of aspartame in humans in humans. In;
Aspartmae: physiology and biochemistry, Stegink LD and Filer LJ, eds. New
York and Boston: Marcel Dekker, Inc., 1984.
4. Searle Research and Development. Long-term tolerance of aspartmae by
normal adults: a pre-marketing, clinical trials study conducted by Gunther
M. Frey, M.D., of Hill Top Research, Inc., Miamiville, Ohio. In Toxicology,
Volume 3 of 4, Aspartmae use as a sweetener in carbonated beverages. FAP
2A3661
——————————————————–
(A special “Thank you” to David and Sherri Price for typing up this huge
report.)
—–
After reading this “full” report you can decide for yourself if
the summary was adequate, correct, or a whitewash. Keep in mind that some
of the studies that approved aspartame were the target of an indictment for
fraud never carried out because two U.S. prosecutors went to work for the
law firm defending the case, which let slip the hounds of disease and death
on an unwarned public. On 60-Minutes (Dec. 29, 1996) Dr. Ralph Walton
admitted that 83 of 90 INDEPENDENT studies on aspartame showed problems.
The 60-Minute spokesman chided the aspartame representitives that 70 of 70
Searle funded tests seemed to show aspartame to be OK (however, it seems
that Searle submitted around 112 documents and two of those studies were
submitted to the Department of Justice for an indictment for fraud). Of
Searle’s many reports the FDA selected fifteen they termed as “pivotal”
to their decision to approve aspartame as safe.
However, Dr. Moser (the Nutrasweet spokesman) admitted to Jennifer Cohen
(http:/www.dorway.com/jcohen.html) that:
“..the study should never have been undertaken, much less submitted as legitimate observation. This particular (RAO) experiment represents an unpardonable breach in methodology.”
If this motivates the reader to action…
http://www.dorway.com/congress.html is a good starting point for locating someone in authority to complain to. Printer Friendly Version
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