Day 039 - 20 Oct 94 - Page 17
1 Q. Sorry, if you just comment on the botched study, the
2 so-called botched study.
3
4 MR. JUSTICE BELL: What I suggest you do is you make your points
5 as shortly as you can. Then if Mr. Morris wants to ask you
6 a question about one of the points you have shortly made,
7 he will.
8 A. OK.
9
10 MR. MORRIS: Can you comment on the study that led to the
11 banning of Amaranth in the States?
12 A. Yes. Could you draw my attention to which paragraph on
13 which page it is, please?
14
15 Q. It is the front page.
16
17 MR. JUSTICE BELL: It is on page 13, second and third
18 paragraphs.
19 A. Page 13.
20
21 MR. MORRIS: Yes. Is that the one?
22
23 MR. RAMPTON: No, my Lord, it is page 12.
24 A. This is talking about the Russian studies.
25
26 MR. MORRIS: Page 13 is starting with subsequent work from the
27 FDA. Is that the famous study?
28 A. It is not present in my -----
29
30 MR. JUSTICE BELL: If you look at 14 the first whole paragraph
31 there.
32 A. Which in the version I have here starts in 1975.
33
34 MR. MORRIS: Yes.
35 A. The FDA -----
36
37 MR. JUSTICE BELL: That is why I thought 13 and 14 were to do
38 with that.
39 A. Yes. Well, it is common in the UK and Western Europe
40 to characterise that study as so botched that it was not
41 possible to rescue any reliable conclusions from it. I
42 have discussed it with the lead investigator, Dr. Collins,
43 and some of his colleagues at the FDA. They strongly
44 maintain that while one can acknowledge some of the
45 shortcomings, there was sufficient precision in knowing
46 which animals in which cages received which doses and which
47 pathology samples on slides came from which animals in
48 which cages at which doses, they did feel confident with
49 their analyses.
50
51 Consequently Amaranth remained banned in the USA. I might
52 say that over the last five or eight years, on several
53 occasions, petitions have been made to the FDA requesting
54 that Amaranth be reintroduced in the United States and FDA
55 officials continue to refuse to accede to those petitions,
56 in part because they remain satisfied with the results of
57 that study.
58
59 MR. JUSTICE BELL: One of the points made against it was that
60 because of the Delaney amendment it did not matter how
