Testamonity before Congress on FDA and Aspartame
Posted: Tue Nov 27, 2001 8:53 am
From l957-l977 I was employed as a Biochemist/Toxicologist in what is now
designated the Center for Food Safety and Applied Nutrition of the Food and
Drug Administration.
During this time my duties were twofold:
1) evaluation of experimental data submitted to FDA in support of the safety of a wide variety of chemicals and processes (such as irradiation) intended for food additive use directly and indirectly, as well as data pertaining to various contaminants such as mycotoxins, pesticides, and also some drugs;
2) a variety of research pertinent to FDA's mission, and for the most part devoted to the overall toxicity and more specifically to teratogenic (birth-deforming) capabilities of several hundred substances that may be broadly classified as food additives, both direct and indirect, or as food contaminants.
In the early l970's, I examined the animal studies submitted by G. D.
Searle and Co. on aspartame prior to the initial approval by FDA in
l974. While I cannot recall any specific examples, it was my overall
impression that these studies raised numerous questions in a number of
areas that needed to be resolved before approval of aspartame for any food
additive use.
In l977 I served as a member of an FDA team (from the Bureau of Foods)
which was charged with examining three studies (the rat DKP long0term
study, and aspartame teratology studies in mice and rats) to determine if
they were 'authentic'. We were instructed to incorporate the findings of
the FDA task force investigation of Searle (Bressler Report) and to
determine whether alterations and adjustments to the data engendered by
inclusion and consideration of these discrepancies resulted in
significantly different results from those presented in the original Searle
submission. This authentication was hence intended to verify that the
submitted data had not been altered, that it reflected the actual outcome
of the study, and that it did not change substantially, particularly in a
statistical sense, the various parameters from which the conclusion of
safety had been derived. Our analysis of the data in this manner revealed
that, in these three studies no substantial change resulted, although in
numerous instances a definitive answer could not be arrived at because of
basic inadequacies and improper procedures used in the execution of these
studies.
I wish to emphasize at this point that we were specifically instructed not
to be concerned with, or comment upon, the overall validity of the study'
this was to be done in a subsequent review carried out at the Bureau
level. It is apparent that that review, on a point by point basis,
discarded or ignored the problems and deficiencies outlined in this Team
report, and concluded that, even in toto, these problems were insufficient
to render the study invalid. It also appears that the serious departures
from acceptable toxicological protocols that were noted in the reevaluation
of these studies were also discounted.
At this point it might be helpful to mention some of the deficiencies and
improper procedures encountered: no protocol was written under the study
was well underway; animals were not permanently tagged to avoid mixups;
changes were introduced in some laboratory methods during the study with
inadequate documentation; there was sporadic monitoring and/or inadequate
reporting of food consumption and animal weights; tumors were removed and
the animals returned to the study; animals were recorded as dead, but
subsequent records, after varying periods of time indicated the same animal
was still alive (almost certain evidence of mixups); many animal tissues
were autolyzed (decomposed) before any postmortem examinations were
performed; and finally, of extreme importance, in the DKP study there was
evidence, including pictures, that the diets were not homogeneous and that
the animals could discriminate between feed and the included DKP. Almost
any single one of these aberrations would suffice to negate a study
designed to assess the safety of a food additive, and most certainly a
combination of many such improper practices would, since the results are
bound to be compromised.
It is unthinkable that any reputable toxicologist, giving a completely
objective evaluation of data resulting from such a study, could conclude
anything other than that the study was uninterpretable and worthless, and
should be repeated. This is especially important for an additive such as
aspartame, which is equally vital since DKP is a major breakdown product of
aspartame in liquid media. Not only is aspartame being used in the absence
of basic toxicity information, but there is also no data to assess the
toxicity of the interactions of DKP with the excess phenylalanine
generated, with any other metabolite of aspartame, and its interactions
with other additives, drugs, or other chemicals which may be present
simultaneously in persons exposed to high levels of DKP in presweetened
liquids such as diet drinks.
While I have not been involved in aspartame safety matters since the team
effort described previously, a brief examination of studies completed and
currently underway seems to indicate that the subject studies have not been
repeated, so the safety questions remain unanswered. It would appear that
the safety of aspartame (and its breakdown products) has still not been
satisfactorily determined, since many of the flaws cited in the studies
referred to here were also present in other studies submitted by
Searle. Dr. M. Jacqueline Verrett
________
More information on aspartame, new medical text on global plague
information and class action on www.dorway.com
[Non-text portions of this message have been removed]
designated the Center for Food Safety and Applied Nutrition of the Food and
Drug Administration.
During this time my duties were twofold:
1) evaluation of experimental data submitted to FDA in support of the safety of a wide variety of chemicals and processes (such as irradiation) intended for food additive use directly and indirectly, as well as data pertaining to various contaminants such as mycotoxins, pesticides, and also some drugs;
2) a variety of research pertinent to FDA's mission, and for the most part devoted to the overall toxicity and more specifically to teratogenic (birth-deforming) capabilities of several hundred substances that may be broadly classified as food additives, both direct and indirect, or as food contaminants.
In the early l970's, I examined the animal studies submitted by G. D.
Searle and Co. on aspartame prior to the initial approval by FDA in
l974. While I cannot recall any specific examples, it was my overall
impression that these studies raised numerous questions in a number of
areas that needed to be resolved before approval of aspartame for any food
additive use.
In l977 I served as a member of an FDA team (from the Bureau of Foods)
which was charged with examining three studies (the rat DKP long0term
study, and aspartame teratology studies in mice and rats) to determine if
they were 'authentic'. We were instructed to incorporate the findings of
the FDA task force investigation of Searle (Bressler Report) and to
determine whether alterations and adjustments to the data engendered by
inclusion and consideration of these discrepancies resulted in
significantly different results from those presented in the original Searle
submission. This authentication was hence intended to verify that the
submitted data had not been altered, that it reflected the actual outcome
of the study, and that it did not change substantially, particularly in a
statistical sense, the various parameters from which the conclusion of
safety had been derived. Our analysis of the data in this manner revealed
that, in these three studies no substantial change resulted, although in
numerous instances a definitive answer could not be arrived at because of
basic inadequacies and improper procedures used in the execution of these
studies.
I wish to emphasize at this point that we were specifically instructed not
to be concerned with, or comment upon, the overall validity of the study'
this was to be done in a subsequent review carried out at the Bureau
level. It is apparent that that review, on a point by point basis,
discarded or ignored the problems and deficiencies outlined in this Team
report, and concluded that, even in toto, these problems were insufficient
to render the study invalid. It also appears that the serious departures
from acceptable toxicological protocols that were noted in the reevaluation
of these studies were also discounted.
At this point it might be helpful to mention some of the deficiencies and
improper procedures encountered: no protocol was written under the study
was well underway; animals were not permanently tagged to avoid mixups;
changes were introduced in some laboratory methods during the study with
inadequate documentation; there was sporadic monitoring and/or inadequate
reporting of food consumption and animal weights; tumors were removed and
the animals returned to the study; animals were recorded as dead, but
subsequent records, after varying periods of time indicated the same animal
was still alive (almost certain evidence of mixups); many animal tissues
were autolyzed (decomposed) before any postmortem examinations were
performed; and finally, of extreme importance, in the DKP study there was
evidence, including pictures, that the diets were not homogeneous and that
the animals could discriminate between feed and the included DKP. Almost
any single one of these aberrations would suffice to negate a study
designed to assess the safety of a food additive, and most certainly a
combination of many such improper practices would, since the results are
bound to be compromised.
It is unthinkable that any reputable toxicologist, giving a completely
objective evaluation of data resulting from such a study, could conclude
anything other than that the study was uninterpretable and worthless, and
should be repeated. This is especially important for an additive such as
aspartame, which is equally vital since DKP is a major breakdown product of
aspartame in liquid media. Not only is aspartame being used in the absence
of basic toxicity information, but there is also no data to assess the
toxicity of the interactions of DKP with the excess phenylalanine
generated, with any other metabolite of aspartame, and its interactions
with other additives, drugs, or other chemicals which may be present
simultaneously in persons exposed to high levels of DKP in presweetened
liquids such as diet drinks.
While I have not been involved in aspartame safety matters since the team
effort described previously, a brief examination of studies completed and
currently underway seems to indicate that the subject studies have not been
repeated, so the safety questions remain unanswered. It would appear that
the safety of aspartame (and its breakdown products) has still not been
satisfactorily determined, since many of the flaws cited in the studies
referred to here were also present in other studies submitted by
Searle. Dr. M. Jacqueline Verrett
________
More information on aspartame, new medical text on global plague
information and class action on www.dorway.com
[Non-text portions of this message have been removed]