Day 039 - 20 Oct 94 - Page 08
1
2 THE WITNESS: Might I make an observation about this? It is
3 correct that of this very small sample of seven patients,
4 only one provided strongly positive evidence of an adverse
5 reaction to Sunset Yellow. It is correct that no reference
6 is made in description of case 7 to the dose or doses used
7 in the test capsule.
8
9 Since reference to dose is made in respect of some of the
10 other patients and, knowing the journal and the authors, my
11 expectation was that if it varied with dose, that is
12 something they would have commented on and that is the kind
13 of thing which the peer reviewers would have required them
14 to comment on.
15
16 So, I think this provides a fragment of information that at
17 least one 32 year-old female adult had a strongly positive
18 adverse reaction. That is, indeed, a small element and
19 tells us nothing one way or the other about the general
20 frequency of it, but is merely, I take it, sufficient to
21 confirm that the suggestion that such adverse reactions
22 occur is not purely mythical, but is well tested.
23
24 MR. RAMPTON: Might I intervene so I do not have to come back to
25 it -- I do not want to. One notices at the top of the last
26 column, page 51 -- to this extent Dr. Millstone is right
27 because we do not get what the dose was. They do, however,
28 record: "Repeated provocation tests with Sunset Yellow and
29 Tartrazine were positive within the thurfyl
30 nicotinate-treated area". That is all we are told about
31 that single case.
32
33 THE WITNESS: It also gives some indication of the severity of
34 the lesions which developed in this unfortunate patient.
35
36 MR. JUSTICE BELL: I just want to say something before we move
37 on. In one or two instances I have had a brief look in
38 advance at some of the papers. If I have a query, I will
39 raise it with you, but you are not to think that I have
40 read them all through and made a list of things which might
41 stand in the way of your case which I can, therefore, put
42 to you, as I did that to Dr. Millstone. But, if no more,
43 I hope that illustrates why I raise the matter in the first
44 place. Yes.
45
46 MR. MORRIS: So, Dr. Millstone, as we go through -- I am relying
47 very much on the witness here as we go through -- any
48 particular references to direct human reactions in your
49 references, if you can point the court to the relevant bit
50 in that particular reference, it might be very helpful.
51 A. OK. I will endeavour to do that.
52
53 Q. As far as Sunset Yellow is concerned, are there any more
54 points you wish to make?
55 A. Not that I can think of at the moment, no.
56
57 Q. Just to sum up, believe it or not, I have tried to work out
58 the numbering system of Professor Walker and the numbering
59 system possibly for Dr. Millstone. But just to clarify
60 Professor Walker's numbering system, in fact, it was
