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
