Day 038 - 19 Oct 94 - Page 40


     
     1        Plaintiffs and ask you just for your conclusion as to its
     2        relevance for this case.
     3
     4        It was passed by the Federal Food, Drug and Cosmetics Act
     5        in America in 1958:  "No additives shall be deemed to be
     6        safe if it is found to induce cancer when ingested by man
     7        or animals, or if it is found after tests which are
     8        appropriate for the evaluation of the safety of food
     9        additives to induce cancer in man or animal".  Do you think
    10        that particular position has any relevance to this case
    11        regarding these additives?
    12        A.  I have long held the view that a similar provision
    13        would be appropriate in UK and European Community, European
    14        Union legislation, but it would need to be worded rather
    15        less ambiguously than the original text of the Delaney
    16        amendment.  The Delaney amendment has within it, because
    17        you read it, that phrase about "tests which are
    18        appropriate", and there is an enormous vagueness there,
    19        because the whole dispute then focuses on what does or does
    20        not count as an appropriate test.
    21
    22        So, the Delaney amendment, as I read it, gives the
    23        superficial impression of being clear and precise but, in
    24        practice, is all too woolly.  But the spirit of it seems to
    25        me entirely sensible.
    26
    27   Q.   If we move on to just before we go to specific matters,
    28        I think Professor Walker's evidence was that the allergic
    29        reactions (which are going to form part of our case) are
    30        not shown up in animal experiments.  Does that lead you to
    31        any conclusions?
    32        A.  It is an unfortunate fact of the poor state of
    33        toxicological science that there are no animal models for
    34        the vast majority of intolerant reactions.  Conceivably,
    35        rodents might suffer headaches but not be able to
    36        communicate the fact that they are enduring these effects.
    37        But they do not have allergic reactions or hyperactive
    38        reactions or develop asthmatic symptoms in the same ways
    39        that sensitive people do.
    40
    41        This is a serious lacuna in toxicology.  There is, as
    42        Professor Walker correctly acknowledges, no satisfactory
    43        animal models for such effects and, therefore, we cannot
    44        rely on the fact they do not show up in animals as
    45        conclusive evidence that they will not cause such problems
    46        in humans.
    47
    48   Q.   Can you explain the role of a double-blind test?
    49        A.  OK.  Since we cannot test for acute intolerant
    50        reactions in animals, we have to rely on studies with what 
    51        I think toxicologists rather unfortunately refer to as the 
    52        target species, namely, human beings.  If you want a 
    53        reliable indication as to whether or not a compound is
    54        having an adverse effect in a human being, it is important
    55        often, but not quite always, to administer that compound in
    56        circumstances when the person being tested does not know
    57        whether or not they are receiving the compound.  In that
    58        respect the studies is said to be a blind-study.
    59
    60        A double-blind study is one in which the person doing the

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