Day 038 - 19 Oct 94 - Page 41


     
     1        administration also does not know whether the subject is
     2        being challenged with a test compound or not.  Typically,
     3        the process is that a third person codes the samples, the
     4        second person administers them to the subject and only
     5        after the effects have been stated and recorded is the code
     6        then broken.  Then it becomes possible to see whether or
     7        not there is evidence that the compound had an effect
     8        without the person receiving it being aware of what they
     9        had received.
    10
    11   Q.   As I understood it -- I might have got it wrong --
    12        Professor Walker was saying that that kind of test would be
    13        one which would be very useful in identifying intolerance
    14        and allergies but it was almost never done?
    15        A.  I agree that evidence from double-blind challenge
    16        studies is amongst the most reliable kind of evidence we
    17        can obtain.  It is also true that there is very little
    18        evidence of that nature, though slightly more than
    19        Professor Walker is prepared to acknowledge.
    20
    21        My understanding, however, from professional clinicians
    22        working in this field, is they have extraordinary
    23        difficulty in obtaining support for studies of that
    24        nature.  It is not that they do not wish to do it, but that
    25        it is only very, very rarely that they are able to obtain
    26        the funding to conduct such studies.
    27
    28        There is another aspect to it which is it is sometimes
    29        difficult to persuade the individuals involved to
    30        participate.  I have myself been involved in attempting to
    31        organise double-blind challenge studies with additive.  The
    32        people who have reported to me that they suspect they have
    33        reacted adversely have said that the effects are so
    34        unpleasant they would not be prepared to submit to a
    35        challenge.  But that is not always the case, nor is it
    36        always the case that funding is not forthcoming.
    37
    38        There have been a few studies, one of the best
    39        conducted  -----
    40
    41   MR. JUSTICE BELL:  Is it not the best thing to do, when we come
    42        to any of the particular compounds in this case where you
    43        think there has been a valid study which has demonstrated
    44        any of the adverse reactions which are set out, or any
    45        other ones, you tell us about it, Dr. Millstone.
    46        A.  I am happy to do that, though I am going to have to
    47        check my files when I get home tonight and bring some of
    48        that information back tomorrow.
    49
    50   MR. MORRIS:  All I am saying is, if there are no double-blind 
    51        studies and animal testing does not show up allergies, 
    52        would it be fair to say that the anecdotal evidence is, 
    53        therefore, the strongest body of evidence that exists at
    54        the moment?
    55        A.  I think that is substantially correct.  I think there
    56        are few fragments of double-blind challenge studies, but
    57        the vast majority of the evidence is anecdotal, but that
    58        the term "anecdotal" is often used to cover a wide variety
    59        of things.  I mean, it can cover merely at the weakest the
    60        casual guessing or ungrounded suspicion, but it can extend

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