Day 038 - 19 Oct 94 - Page 34
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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.
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12 MR. MORRIS: OK.
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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.
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18 MR. MORRIS: Yes, thank you.
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20 MR. JUSTICE BELL: Yes.
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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.
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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.
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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
