Day 038 - 19 Oct 94 - Page 34


     
     1
     2   MR. JUSTICE BELL:  I would have to say I would not need any
     3        persuading about that and every time something looms where
     4        there might be a suggestion that taking part in the
     5        promotion process does not amount to a cause or a causatory
     6        factor, I have to stop and think, because no doubt I will
     7        hear or I may hear some argument about this, but at the
     8        moment if a factor promotes cancer it seems to me it is
     9        causatory, no doubt with other factors, but that it has a
    10        causatory effect.
    11
    12   MR. MORRIS:  OK.
    13
    14   MR. JUSTICE BELL:  But I am merely saying that now because it is
    15        something which has crossed my mind from time to time over
    16        the last few days.
    17
    18   MR. MORRIS:  Yes, thank you.
    19
    20   MR. JUSTICE BELL:  Yes.
    21
    22   MR. MORRIS:  If we just forget that last question.  When a
    23        hazard is identified in a test, but in many tests the
    24        hazard has not been identified, is equal weight given to
    25        it?  Is it a question of juggling the numbers or evening it
    26        out, or what is the significance of finding a hazard?
    27        A.  There are different views on this, as you can
    28        appreciate.  There are those who think that an appropriate
    29        way of making policy is, as it were, to count the number of
    30        studies in which there is evidence of hazard and count the
    31        number of studies in which there is no evidence of hazard
    32        and take the majority view.
    33
    34        That is not an approach I would endorse.  It seems to me
    35        that what matters is, in part, the methodology of the study
    36        involved, such that a very thorough and careful study on a
    37        large population of animals which showed an apparent
    38        hazard, I would deem that to be more relevant and ascribe
    39        greater weight to it than a study which showed no apparent
    40        adverse effects but conducted over a short time with a
    41        small group of animals.
    42
    43        But other things being equal, given that the objective of
    44        policy, as I see it, is primarily the protection of public
    45        health, evidence of an adverse effect is of very great
    46        importance, and I would not think it right to disregard it
    47        merely because there were many other studies in which that
    48        similar phenomenon had not arisen without a clear
    49        appreciation of the different circumstances of the
    50        different studies. 
    51 
    52        If, for example, you had multiple studies of the same 
    53        compound in the same variety of the same species and an
    54        adverse effect appeared only once, one might think of that
    55        as a random fluctuation or statistical artefact.  But if it
    56        happened in a particular animal, a variety or species, and
    57        not in others, it might be appropriate simply to identify
    58        that as the most sensitive species and that by reference to
    59        which, if one is to set an ADI, that ADI should be set.
    60

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