Examination of Witnesses (Questions 20
- 39)
TUESDAY 11 APRIL 2000
BARONESS HAYMAN,
MR RAY
ANDERSON AND
PROFESSOR IAN
AITKEN
Mr Drew
20. We are talking about the process of the
decision but I think this is very pertinent and I think Austin's
line of question is very important. I would like to follow up
with this. We are talking here about the cautionary principle,
not the precautionary principle because the problem has already
happened. I just wonder how much you have dwelt upon, for those
people who have been medically diagnosed or possibly will be,
how much impact that will have in terms of trying to bring forward
the explanations and obviously, in due course, possible litigation.
(Professor Aitken) It is difficult to be definitive
about the actual causes of the illnesses which have been reported
through the reporting system because, as I have indicated previously,
there very often is only limited information and very often unsupported
by any medical history or diagnosis, so I think it is difficult.
The appraisal panel's function is not to ascribe causality to
individual cases but to try to identify trends in the emergence
of adverse report incidents that are drawn to it. Those adverse
reports come in two ways: one is mandatory requirements upon the
manufacturing company to report to the Veterinary Medicines Directorate
as the regulatory body anything that becomes known to them about
adverse reactions from the use of their products—and that
includes human adverse reactions as well as animal—and the
other is a form of reporting which is totally voluntary by individual
people or by their veterinary surgeons, again to the Veterinary
Medicines Directorate. As I have said, many of these reports are
of limited content and do not give sufficient information to enable
backtrack to be made to determine with certainty whether there
is a causal link and it is not part of the purpose of the SARSS
(Suspected Adverse Reaction Surveillance Scheme) team to ascribe
individual causality but individual trends. There is an Appraisal
Panel which deals specifically with these relating to human adverse
reactions as opposed to animal adverse reactions.
21. But in terms of people who may not have
been diagnosed but who suspect they are suffering from OP poisoning
this will justify their stance; clearly I imagine they are talking
to people at this time, the OP networks which have already been
referred to, and they will be taking advice. How will you respond
if and when people do come to you and say, "You have taken
the decision, I suffer now because of what happened in the past"?
How will you cope with that and will you deal with that evidence,
because that will impact upon the individuals?
(Baroness Hayman) The licensing authority will have
to answer for its judgments about the licensing of product and
the licensing authority is ministers. We have to take account
of the advice of the VPC under the Medicines Act but responsibility
is with us and judgments will be made, if you talk about potential
litigation, as I think you were suggesting, about the appropriateness
of the judgments made on the evidence that was available. I have
tried to give the committee some sense of the growing scientific
work that has been done in this field and the reaction through
the regulatory process to that. Mr Mitchell was talking about
whether the committee only looked at what came in from manufacturers.
Of course, this particular piece of regulatory action is taken
very clearly on the result not of something that came from manufacturers
but first the Institute of Occupational Medicine report published
in July that ministers then asked the VPC for advice on, and that
led to asking for the manufacturers to submit new designs, and
then the Committee on Toxicity report that was published at the
end of November, and again we asked all the advisory committees—
Mr Mitchell
22. But your argument is particularly dangerous
here in that there is a recommendation from Lord Zuckerman in
1951 and from the Health and Safety Executive in 1980 that workers
exposed to OPs on a regular basis should have their blood cholinesterase
levels measured pre and post exposure. Now that recommendation
was never enforced. Why?
(Baroness Hayman) That is asking me to answer far
further back than Mr Rooker.
23. Yes, but you are saying the committee was
doing its job and then other concerns arose and you took action
but here was a concern expressed before that and which should
have been on-going.
(Baroness Hayman) The VPC was not in existence—am
I right or wrong?
(Mr Anderson) Certainly not in 1951.
24. But it was aware of these recommendations
and it did not take any steps to say, "If we are going to
license this and it is going to be used, these precautionary steps
should be taken".
(Professor Aitken) I think you should take into account
all the recommendations that were drawn to the users' attention
on the means to use dips safely. It has always been the Veterinary
Products recommendation that these particular products should
be used with care and caution and very clear guidelines have been
given what that means in practice, both through the design of
the dip and the engineering controls that are involved when sheep
are put through dips and also the particular type of protective
clothing that individuals should wear to protect themselves from
the hazards of exposure, and exposure in real terms is contact
with the skin. That is the main route, and it is the concentrate
which is the principal culpable agent. So there are requirements
dating back a long time—I cannot give you specifics but
they are very clearly there—as guidance to users as to how
they can minimise or avoid contact with the dip, whether it be
in concentrate or dilute form.
Mr Mitchell: It is right to make those warnings
but, human nature being what it is, there will be mistakes and
it says here in this HSE recommendation of 1980 that there should
be regular blood checks on those exposed to it.
Chairman: Can I remind members of the Committee
that we are basically dealing with the process over the last few
months. I realise it is relevant but at the same time what is
particularly relevant is the decision-making process and I am
anxious to remain on track. I am going to be tolerant but not
permissive.
Mr Mitchell: There should be an answer to the
question—
Chairman: We will do a wind-up and perhaps you
can have one then.
Mr Jack
25. Chairman, I hope my line of questioning
will not deviate too much from your most recent stricture. Following
on from the comments that were made earlier and bearing in mind
we are not dealing with a brand new risk, as we have just heard
outlined, in paragraph 3.1 of the Ministry's own evidence you
comment on the Institute of Occupational Medicines' report which
we have just heard mention of, published in July where, it "identified
the handling of concentrated OP dip as the main source of potential
exposure". Now that is rather soggy language. They had three
years to study this and it is this evidence which triggers the
events which we are exploring and it says "potential exposure".
Could you tell me a little bit more about what the "potential"
means? Can we put any kind of risk factors, numerically on this?
What made the bells ring when you read this word "potential"
after three years of intense study?
(Professor Aitken) I cannot do other than reiterate
what I have said previously—that the potential for harm
is there but the way of avoiding that risk is to wear proper protective
clothing and to exercise care in the handling of the product.
It is when that care breaks down that the potential can be expressed
as reality.
26. Yet in paragraph 3.3 of the same evidence,
referring to the Committee of Toxicity's report published in November,
according to MAFF, that "concluded that the balance of evidence
did not support the hypothesis that prolonged or repeated low-level
exposure to OPs caused peripheral neuropathy or clinically significant
neuropsychological effects. It indicated that, if such effects
did occur, they must be relatively uncommon. There remained a
question, however, over whether there might be a small group of
individuals particularly susceptible to OPs". Now the language
there suggests a lot of unknowns. "There remained a question"—this
is after all this work has been done—"however, over
whether"—we are not quite certain—"might"—still
not certain—"be a small group"—unspecified—"particularly
susceptible to OPs". We have known that since the 1950s and
yet, on the basis of this rather soggily worded finding, we now
find actions which have affected the practical availability of
this product. Are you content that this is robust science?
(Baroness Hayman) If I can speak practically, I do
not think that that was the basis for taking regulatory action
against the concentrate and trying to minimise the risk of exposure
to concentrate. That was the basis for having more research to
find out whether even low levels of exposure, even according to
all the advice and using substance safely, according to HSE accounts,
could still cause harm. That is the nub of the debate about whether,
in any form, OPs should be allowed to be used as veterinary medicines.
What we are talking about is something much more practical: how
we minimise the exposure and the risk of someone having concentrate
coming on to their skin when they are undertaking that which you
rightly point out to me a difficult task of sheep dipping. I do
not think you can base on 3.3 the regulatory action that we took
about in terms of the concentrate.
27. I am glad you clarify that. It is difficult
to map my way through because in justification it says "Research
and Committees' advice" in paragraph 3 of your own evidence.
(Baroness Hayman) But that is the research that suggested
to the VPC that they should not recommend to the regulatory authorities
that they refuse to license OP sheep dips. That is not what we
have had recommended to us and that is not the regulatory action—
28. And yet the practical implications of the
action you have taken appears to have minimised the ability of
sheep farmers to get the preparation in time for sheep dipping?
(Baroness Hayman) Well, certainly this year there
is a problem on availability of OP sheep dips and I would not
suggest otherwise. I think the question that I had to wrestle
with was whether the risk was such to justify the potential taking
off the market of a product that many farmers wanted to have available
to them and whether the action that was taken was proportionate
to the risk. In doing that, I take very much the advice, as I
have a responsibility to do, of the Veterinary Products Committee,
which does have amongst its membership people who are far more
experienced than me in these areas.
29. Finally, is there any way you can quantify
these risks for us, because the language here in scientific terms
is soggy, as a layman, and I have not had the benefit of reading
all the full report so all the points I am asking about may have
been comprehensively dealt with, but can the experts give me some
kind of risk analysis in numbers I might understand as to what
happens in the light of your recommendations or what does not
happen?
(Baroness Hayman) If that could have been it probably
would have been done in 1951 after Lord Zuckerman and we would
not have been having these arguments for the last 50 years!
30. We have had four or five years' work on
the job so we should be nearer getting some of these answers,
should we not?
(Baroness Hayman) I think we are and it is because
we have been honing down on issues like exposure to concentrate
and engineering solutions to make sure people are not exposed
to concentrate that we have got to the point where we have—but
I am not the expert.
(Professor Aitken) I will just add to what the Minister
has said. The remit of the Veterinary Products Committee is to
evaluate matters of product safety and efficacy of products that
go on to the open market. Were the current OP concentrate forms
to come as a totally novel presentation to the committee, they
would not pass because the containers in which the concentrate
is supplied does not meet the best standards that are required
at the present day and we know from all the medical evidence and
all the scientific evidence that the risk factor lies in the concentrate—not
in the dilution—and, therefore, it is necessary to take
steps which justifiably would require the manufacturers to produce
the product in a form which is as safe as it can be, and that
is what we have asked for. Not to revoke the authorisation of
OPs for ever but simply until there is an improvement in the design
of the containers of concentrate that satisfies the need to minimise
the risk to the user.
Mr Paterson
31. Could I begin by stating that I am a member
of the Council of British Leather Confederation and Vice President
of the European Confederation of Tanners and Leather Dressers.
(Baroness Hayman) You have interests in this area,
as I know.
32. I have interests but I am not paid—which
is sad. I would like to pick up on Mr Mitchell's earlier line
of questioning and just ask in simple terms that for some years
this scandal has been brewing and now action has been taken. Can
you give the committee three reasons to show that, first of all,
the relevant authorities would pick up on such a case quicker
in future and that human health would not be damaged in the way
it has been? What have you actually changed?
(Baroness Hayman) Three reasons to suggest that—
33. —you would pick up on the problems
quicker and to reassure us and the public. We have a submission
here that 500 people have been affected, for instance?
(Baroness Hayman) The Royal College of Physicians'
report on OPs I think was a major factor in ensuring that general
practitioners, in particular in areas that were not perhaps those
where sheep farming was concentrated and therefore issues about
exposures to OPs were best known, were spreading the awareness
and the Department of Health has taken action since then, and
Mr Anderson will remind me about setting up some reference centres
that GPs who are concerned about patients can go to and publicising
those.
(Mr Anderson) Through the national poisons information
centres to which GPs are directed for further information on the
symptoms of OP poisoning.
(Baroness Hayman) Secondly, the piece of research
we are funding is just about to start on the patients who have
self-reported as having effects from OPs because that will be
very important again in seeing whether there is a pattern of symptoms
or exposure which then we can pick up on through advice, through
farming unions, through people who use or come into contact with
the product afterwards so that we have a set of potential symptoms
or effects that ought to be sending warning bells to people. I
suppose, thirdly, I would mention the action that we took in December,
the four-point plan we put forward on the advice of the Committee
on Toxicity, the whole work that has been done over time including
the Institute of Occupational medicine, and the government's work
to bring together the official group which published its report
in 1998 on OPs, the increased advice available. We sent out, for
example, to every registered sheep owner in the country a booklet
of advice that was brought up jointly between the HSE and the
Veterinary Medicines Directorate so people are alerted both to
the potential risks and what can be done to avoid the risks but
equally to know that they ought to pick up on things afterwards.
Dr Turner
34. Professor Aitken, you said that the containers
in use would not be allowed nowadays but it is often the nature
of science and progress that new build is often built to higher
standards than old and in recalling old or insisting that all
buildings are brought up to today's standards we have to balance
risk against cost and disruption. I would like to ask some questions
about the scale of risk that you saw in not taking fairly dramatic
action. I could not find in the report from the ministry words
which summarised that for me so I wondered if I could ask for
a summary of what you saw the risk was in allowing the concentrate
to be used in its present containers?
(Professor Aitken) Yes, I will try to do that for
you. I will start by reminding you of the some of the points that
the Minister has made. This was not a sudden decision but one
progressing over a number of years with recommendations to the
manufacturers to improve container design, going back to about
1993/94. They have progressed and improved the designs of their
containers—some individual manufacturers more enthusiastically
than others—
35. Can I interrupt you there. Were you happy
with those modifications at that time, in 1994/95?
(Professor Aitken) At the time they were progressing
they were meeting the requirements that were there then. There
were better things that could have been done but at that time
there was no urgent reason to get them to move further forward.
However, there has been a recommendation on the part of the committee
going back to about 1997 that technology has now progressed to
the point where those totally closed systems for dispensing concentrates
should be attainable. One alternative is the use of water soluble
sachets. These systems have been adopted by chemical laboratories
and have quite considerably reduced the hazard of contamination
by chemical workers because of these systems. The comment that
we made in July reinforced that message and the report which accompanied
the press release and which was made publicly available, without
prescribing what manufacturers should do, certainly mentioned
both the opportunities for closed systems and water soluble sachets.
What brought matters more closely to our attention was the Institute
of Occupational Medicine's report which demonstrated clearly and
unequivocally that the existing containers were a source of potential
contamination, potential because if people were not taking the
right precautions potential could become real, that the use of
containers designed then were short of standards that ought to
be expected. In looking at any form of critical path analysis
for hazard, that very clearly was signalled and there was a requirement,
therefore, on manufacturers to bring forward plans to improve.
36. But you have not told me what the words
were that made you think the risk to human health was suddenly
seen as large. Is there any word you can quote from a report?
I could not find any in the summary.
(Professor Aitken) It is a well-established fact that
exposure to concentrates is the greatest hazard to human health.
Mr Jack
37. If a dipper of sheep is properly dressed
in the approved special clothing—gloves, boots, everything
else—what is the risk then?
(Professor Aitken) It is reduced if the correct clothing
is worn all the time and is not clothing which has deteriorated.
38. Reduced to what level?
(Professor Aitken) It is extremely difficult to quantify
because one cannot be absolute but it is very substantially reduced.
I think that is the best I can offer you.
Dr Turner
39. I was interested in the word you used that
you were advised to withdraw it from the market and one of the
distinctions being made here is in fact the order to withdraw
it from use which is a very different thing from withdrawing it
from sale. Was that distinction discussed and were alternatives
discussed, such as has been suggested might have been available,
including, for example, limiting it to trained people or people
who have received some extra warning. Were those alternatives
actually discussed and was the distinction between market and
farm made?
(Mr Anderson) On the technical issue, when marketing
authorisations are suspended, what is forbidden is both placing
on the market and administration of the product. Because, of course,
we were taking urgent action of this sort, we took legal advice
and it was established that our interpretation was correct; that,
in suspending a marketing authorisation, it became illegal both
to sell and to administer the product and, because of issues raised
with us by the industry, we took that concern to the European
Commission, because the action that we were taking was under UK
law implementing community directives and we received confirmation
from the officials within the Commission that, because the action
was taken on safety concerns, we were correct in suspending the
marketing authorisations to require withdrawal not just from the
supply chain but from the end users.
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