* Animals which had died were sometimes recorded as being alive and vice versa. "These include approximately 20 instances of animals reported as dead and then reported as having vital signs normal again at subsequent observation periods." (Gross 1985, page S10835)
* "Selecting statistical procedures which used a total number of animals as the denominator when only a portion of the animals were examined, thus reducing the significance of adverse effects."
(Schmidt 1976c, page 4 of US Senate 1976b)
* G.D. Searle told the FDA that 12 lots of DKP were manufactured and tested in one study, yet only seven batches were actually made.
(Gross 1985, page S10835)
* "Significant deviations from the protocols of several studies were noted which may have compromised the value of these studies . . . In at least one study, the Aspartame 52 weeks monkey study, the protocol was written after the study had been initiated." (Gross 1985, page S10835)
* "It is significant to note that the Searle employee responsible for reviewing most of the reproduction studies had only one year of prior experience, working on population dynamics of cotton tail rabbits while employed by Illinois Wildlife Service. In order to prepare him for this title of 'Senior Research Assistant in Teratology' (fetal damage) Searle bought him books to read on the subject and also sent him to a meeting of the Teratology Society. This qualified him to submit 18 of the initial tests to the FDA, in addition to training an assistant and 2 technicians. He certainly
must have kept them busy because Searle claimed that 329 teratology
examinations were conducted in just 2 days. He estimated that he
himself examined about 30 fetuses a day, but officials for the Center for Food and Applied Nutrition could never determine how that was possible."
* "In each study investigated, poor practices, inaccuracies, and discrepancies were noted in the antemortem phases which could compromise the study."
* "Presenting information to FDA in a manner likely to obscure problems, such as editing the report of a consulting pathologist . . . Reporting one pathology report while failing to submit, or make reference to another usually more adverse pathology report on the same slide." (Schmidt 1976c, page 4-5 of US Senate 1976b)
* Animals were not removed from the room during the twice per month exterminator sprayings. (Gross 1985, page S10836 of Congressional Record 1985b)
* Often the substance being tested which was given to the animals was not analyzed or tested for homogeneity. "No records were found to indicate that any treatment mixtures used in the studies were ever tested or assayed for pesticide content . . . Running inventory records for either treatment mixtures or the test compounds used in treatment mixtures are not maintained."
* In the Aspartame (DKP) 115 week rat study the written observations of the pathology report was changed by the supervising pathologist, Dr. Rudolph Stejskal even though he was not physically present during the autopsies and could not have verified the observations of the pathologist who did perform the autopsies. The pathologist who did perform some of the autopsies had no formal training for such procedures.
* "Contrary to protocol, slides were not prepared of this [unusual lesions from the Aspartame (DKP) study] tissue for microscopic examinations . . . ."
* "In the Aspartame 46 weeks hamster study, blood samples
reported in the submission to FDA as 26 week values (for certain
specified animals) were found by our investigators as being, in fact, values for different animals which were bled at the 38th week. Many of the animals for which these values were reported (to the FDA) were dead at the 38th week." (Gross 1985, page S10838)
"It is apparent from the report, that the Appendix portion contains all the individual (animal) values of clinical lab data available from the raw data file. A selected portion of these values appears to have been used in computing group means (which were reported to the FDA). It is not clear what criteria may have been used for selecting a portion of the data or for deleting the others in computing the means (reported to the FDA)." (Gross 1985, page S10838 of Congressional Record 1985b)
* "Searle technical personnel failed to adhere to protocols, make
accurate observations, sign and date records, and accurately administer the product under test and proper lab procedures."
* [There were] "clerical or arithmetic errors which resulted in reports of fewer tumors."
* [G.D. Searle] "delayed the reporting of alarming findings." FDA
Toxicologist and Task Force member, Dr. Andrian Gross stated: "They [G.D. Searle] lied and they didn't submit the real nature of their observations because had they done that it is more than likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study.
In conclusion: The economic impact of banning Aspartame is outweighed infinitely by the invaluable improvement in the health of your constituents.
* "Selecting statistical procedures which used a total number of animals as the denominator when only a portion of the animals were examined, thus reducing the significance of adverse effects."
(Schmidt 1976c, page 4 of US Senate 1976b)
* G.D. Searle told the FDA that 12 lots of DKP were manufactured and tested in one study, yet only seven batches were actually made.
(Gross 1985, page S10835)
* "Significant deviations from the protocols of several studies were noted which may have compromised the value of these studies . . . In at least one study, the Aspartame 52 weeks monkey study, the protocol was written after the study had been initiated." (Gross 1985, page S10835)
must have kept them busy because Searle claimed that 329 teratology
examinations were conducted in just 2 days. He estimated that he
himself examined about 30 fetuses a day, but officials for the Center for Food and Applied Nutrition could never determine how that was possible."
* "In each study investigated, poor practices, inaccuracies, and discrepancies were noted in the antemortem phases which could compromise the study."
* "Presenting information to FDA in a manner likely to obscure problems, such as editing the report of a consulting pathologist . . . Reporting one pathology report while failing to submit, or make reference to another usually more adverse pathology report on the same slide." (Schmidt 1976c, page 4-5 of US Senate 1976b)
* Animals were not removed from the room during the twice per month exterminator sprayings. (Gross 1985, page S10836 of Congressional Record 1985b)
* Often the substance being tested which was given to the animals was not analyzed or tested for homogeneity. "No records were found to indicate that any treatment mixtures used in the studies were ever tested or assayed for pesticide content . . . Running inventory records for either treatment mixtures or the test compounds used in treatment mixtures are not maintained."
* In the Aspartame (DKP) 115 week rat study the written observations of the pathology report was changed by the supervising pathologist, Dr. Rudolph Stejskal even though he was not physically present during the autopsies and could not have verified the observations of the pathologist who did perform the autopsies. The pathologist who did perform some of the autopsies had no formal training for such procedures.
* "Contrary to protocol, slides were not prepared of this [unusual lesions from the Aspartame (DKP) study] tissue for microscopic examinations . . . ."
* "In the Aspartame 46 weeks hamster study, blood samples
reported in the submission to FDA as 26 week values (for certain
specified animals) were found by our investigators as being, in fact, values for different animals which were bled at the 38th week. Many of the animals for which these values were reported (to the FDA) were dead at the 38th week." (Gross 1985, page S10838)
"It is apparent from the report, that the Appendix portion contains all the individual (animal) values of clinical lab data available from the raw data file. A selected portion of these values appears to have been used in computing group means (which were reported to the FDA). It is not clear what criteria may have been used for selecting a portion of the data or for deleting the others in computing the means (reported to the FDA)." (Gross 1985, page S10838 of Congressional Record 1985b)
* "Searle technical personnel failed to adhere to protocols, make
accurate observations, sign and date records, and accurately administer the product under test and proper lab procedures."
* [There were] "clerical or arithmetic errors which resulted in reports of fewer tumors."
* [G.D. Searle] "delayed the reporting of alarming findings." FDA
Toxicologist and Task Force member, Dr. Andrian Gross stated: "They [G.D. Searle] lied and they didn't submit the real nature of their observations because had they done that it is more than likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study.
In conclusion: The economic impact of banning Aspartame is outweighed infinitely by the invaluable improvement in the health of your constituents.
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