Examination of Witness (Questions 280 - 299)
TUESDAY 19 MAY 1998
MR JEFF ROOKER
280. If you have had that many letters on it, there are obviously
thousands of people using these things, and it is surprising that
nothing from them corroborates the Dalton and Dalton finding that
there are levels which are damaging. There has been nothing to
indicate damage below 100 mg.
(Mr Rooker) But the fact remains, even though—
281. Or 200 mg.
(Mr Rooker) I still emphasise the difference between
the Americans and ourselves is the safety factor. For Dalton and
Dalton to be completely and utterly rubbished, you have to dismiss
the peer group review it went through. This is not a letter in
a medical journal, so it is not as straightforward and as clear
cut and as black and white as you assert. You have made your mind
up, that is okay.
282. I have not made my mind up.
(Mr Rooker) Perhaps I am being antagonist towards
you, and that is the last thing I wish to do, but you are so dead
certain about it. We cannot be that dead certain in the sense
we have some advice which gives us a warning to take some precautions
about the levels of a high dose supplement, sold as a food but
masquerading as a medicine.
Chairman
283. Minister, there are always people out there who are
prepared to make outrageous claims about individual products.
In your field on BSE, I can name you academics who are making
outrageous and unsubstantiated claims, which to your great credit
you ignore. This document is ten years old and has not been replicated
by anyone since, and COT itself admitted it is methodologically
flawed, and the peer group review which it went through is just
to permit publication, nothing more than that.
(Mr Rooker) Well, publication depends where it is,
of course. We are not talking about journalism here, with respect,
Peter, we are talking about scientific literature. We are not
quoting articles in the newspapers just as they appear and saying
that counts—
284. Woman and Home?
(Mr Rooker) Well, no, because that is advice being
given by a medical practitioner, a GP. I do not know the background
to that but you cannot simply dismiss scientific journals and
equate them, if you like, with journalism. There would be no point
making policy based on scientific advice, if that was the case.
Mr Todd
285. Do you think COT is the right body to advise you on
this subject, or advise the FAC on this subject?
(Mr Rooker) COT advises the Department of Health,
it advises different government departments, because as you have
heard they have no programme of their own. They operate on the
basis of requests put to them. A lot of other advisory committees,
being independent, create their own agenda, which of course is
quite right. In this case, our advice comes from the Food Advisory
Committee which is not expert on toxicity, it has Professor Woods,
and a range of scientific food technology staff as well as consumers,
I might add. Mainstream consumer opinion by and large tends to
support the action we are taking.
286. You have set up the expert group on vitamins and minerals.
In the brief, in paragraph 33 of the evidence you have given to
us, one of the terms of reference it will have once it gets going
is to "recommend maximum levels of intake of vitamins and
minerals from supplements if appropriate", which seems to
be pretty much what COT has given the FAC advice on. Is it reasonable
to say that?
(Mr Rooker) Yes. The fact of the matter is it will
take matters further but we set that up simply because it seemed
to us COT has got other work to do, requested by other government
departments. We want the industry to be involved, consumers, outside
bodies and observers, and the new expert group is formed by members
of four separate advisory committees including one of our consumer
representatives, and we have representatives of alternative medicine
and mainstream medicine on there.
287. Would you not say that is a far better group to look
at an issue of this kind than COT?
(Mr Rooker) Yes. Two, two and a half years ago, it
would have been the obvious group to refer it to, absolutely.
288. I am certainly not criticising what happened, I am just
saying it looks as if that is a rather better model particularly
as you will have the opportunity to at least have the advice of
the industry and complementary medicine. If I might say, I am
familiar with the fact complementary medicine is a matter of controversy
in the medical field and how you deal with that. There are many,
both learned medics and also GPs, who take very different views
on the issue of complementary medicine, so I am delighted to see
that reflected in that. Would it not be better, without wishing
to get you to pre-judge how you deal with this consultation, to
refer this issue back to your newly formed expert group for a
rather more considered and balanced judgment based on the different
interest groups who have been reflected in that?
(Mr Rooker) Obviously, as you can imagine, in discussing
setting up the expert group we did consider this. That is not
to say we have just gone blindly down the alley. We considered
whether or not on B6 which, as I say, has been around for consideration
for a considerable period of time, we should cut the thing off,
set up the new group, and kick it into touch. The new group will
not report for 18 to 24 months or thereabouts. By the time it
reports I sincerely hope it will be reporting into the Food Standards
Agency not into MAFF because it will report to the Food Advisory
Committee which will be a Food Standards Agency operation. We
took a view, Mark, honestly that given the work that had been
done by COT on two occasions, given the work that had already
been done by the Food Advisory Committee was that notwithstanding
the consultation we are going through now and other opinions that
may come forward, that the evidence we had was robust enough that
we would be failing if we had got this advice that there is a
risk (it is not a serious risk but it is a risk) because of the
high-dose food supplement taken on a daily basis, and we had simply
ignored that knowing that it will be two years or more before
the expert group comes to a conclusion and we do not know how
the expert group will work because they will set their own agenda
because they will look at the whole range of food and dietary
supplements. Here we have a whole range of supplements, the history
of which I have gone over as to why they are being looked at,
and it did not make sense to us. Frankly, on public health grounds
in terms of precautions over this, to simply ignore what has been
done, ignore the advice, let someone else deal with it in two
years' time—
Chairman: We are beginning to have a rather general discussion
and we have got some quite structured questions to get through
and we are not making much progress through them. I know you have
to be away before seven o'clock so I would like to move back to
our structured questions. Diana Organ?
Mrs Organ
289. Two brief questions. Did you base your decision to accept
COT's advice on the precautionary principle?
(Mr Rooker) Well, that was a factor. It is bound to
be a factor of anything where you are, if you like, imposing a
restriction or something like that or curtailing supply. We have
got advice that you have seen that you could argue lacks precision
but there is enough doubt there for a reasonable person concerned
with food safety taking a precautionary view to say, "Well,
we can't just leave it alone." You have to appreciate also
that there have been attempts in the past, I do not put any great
store by this, to get a voluntary procedure for warnings on labels.
This was not acceptable to the industry. Probably from their point
of view they were not going to put a warning on a label "Don't
take more than 10 mgs a day of this" when the tablets in
there are 50 or 200 mg. That to them did not make sense. A voluntary
approach was attempted by my predecessors. That was not an acceptable
way forward and therefore having a look at the situation we inherited
and the advice we received and being precautionary about it that
has to be a factor, yes.
Mrs Organ: Personally at the moment I am taking 200 mg a
day of vitamin B6.
Mr Hayes: We wondered what the problem was!
Mr Mitchell: Ask it quickly, you might not last!
Mrs Organ
290. My children say I am a lot calmer. If there is a real
risk to public health why has it taken so long—I appreciate
you have inherited this from the previous administration—to
introduce these regulations using the precautionary principle?
(Mr Rooker) I have said it is invidious to make comparisons
with other difficulties. The Chairman has already uttered the
three letters and I do not want to go down that road. We could
argue that it was not a massive urgent serious risk that required
action this day this month. We have gone through a process of
listening to what is being said by the industry, looking as how
we could construct the regulations—it is not just our regulations,
it is the medicines regulations as well—as to how we take
account of the fact B6 is not sold in Yorkie bars and things like
that. The regulations are very carefully drafted. The lawyers
have had to look at it. Officials have had to consider what has
been said, consider, if you like, the representations that have
been made through Members of Parliament and through industry over
the months. That has occupied both the lawyers and the policy
advisors. I make no apology for that. I will be accused of rushing
to judgements and yet the implication is I have taken too long
over doing it. There is not one single reason why we are here
in May in the middle of a consultation process. I fully admit
our expectation was to try and get the recommendations published
by January time. I freely admit that there were other things on
the boil in MAFF.
291. Is one of the reasons why it has taken so long the cost
that would thrown on to the Health Service if the regulations
are put through in the way that you have outlined and the extra
work that will be thrown upon GPs and the Health Service?
(Mr Rooker) No. It has not been an issue. The Department
of Health has not deviated one iota from the original decision
of the joint Food Standards Safety Group which is headed by Jack
Cunningham, Frank Dobson, myself and Tessa Jowell working across
both Departments. We have no difficulty whatsoever. The Medicines
Control Agency and the Committee on Safety of Medicines looked
at their side of work and produced their procedures a lot quicker
than ours. Ours were more complicated to do because it was an
area MAFF had not dealt with previously. We have no concerns about
the impact of the controls on the NHS or GPs. No health professionals
have voiced concerns about pressure on the NHS. The doctors' drug
budgets take account of medicines that come on and off lists from
time to time. We do not know of course, because we do not have
sufficient data, the number of people on B6 between 10 and 50
mg. We know some of those over because they get it from a doctor
now and that is why we have got the odd yellow form procedure.
There is no surveillance procedure of course for B6. In some ways
I fully admit that there is no way we could know either because
of the nature of product and the way it has been sold.
292. Will that lead to inconvenience to the women at present
taking it? Is that another reason why you have not brought the
regulations in?
(Mr Rooker) Inconvenience in what way?
293. Women who at present can walk along the high street,
walk into a shop and purchase over the counter vitamin B6 supplement
at the level that they feel they need to take it will now have
to go to maybe their GP or go and find their pharmacy and get
it that way.
(Mr Rooker) What you say is going to happen but that
has not been a factor in the reasons for what you would argue
is a long time bringing in the regulations. What you have spelt
out is the reality of what is going to happen. There will be a
run on 49 mg doses.
294. Yes there will.
(Mr Rooker) That is right so you will be on four of
those a day.
Mrs Organ: Thank you.
Mr George
295. I note and we all note your constant reference to the
precautionary principle which we assume could be interpreted as
regulating until an item like vitamin B6 can be proven to be safe
and you also say that you will not be bullied, if you like, by
the weight of letters or the size of the wallets of the lobby
that happens to be hitting you. Yet with genetically modified
organisms, pesticides and organo-phosphates the burden of proof
appears to be the other way round. Let me put it to you that you
are picking on the health food industry because they are smaller
operators than the larger multi-national pharmaceutical companies
involved in agri-business.
(Mr Rooker) That would not be the view of those manufacturers,
let's say, of pesticides and veterinary medicines based on organo-phosphates
who think all kinds of weird and deadly things are going to happen
to their industry because of what we have said based on the precautionary
principle and the best independent science that we can get. These
are issues currently in play in government. I read on Sunday—and
it is quite outrageous and I deny this—that apparently I
have had discussion with the pharmaceutical industry and drug
companies. I read on Sunday, "Rooker, on the advice of the
drug companies, is proposing to ban B6". That sort of thing
is actionable, to be honest. I make no bones about that. Ignorance
of the effect on industry would be ridiculous, but that cannot
be the factor I take into account as Food Safety Minister. That
would not be my key responsibility, to be honest.
296. But the burden of proof in those cases is the other
way around, in the sense you would only regulate if it was proven
to be unsafe, whereas in the case of B6 you are saying you are
taking your preferred principles and you are regulating only if
it can be proved to be safe.
(Mr Rooker) No, it is not like that.
297. There is an inconsistency, is there not?
(Mr Rooker) No. The thing with some of the regulatory
procedures we use, the sort of things you quoted—and the
pharmaceuticals are involved whether it is animals or humans,
a lot are the same companies—is that a lot of these are
subject to pre-marketing approval where they have to go through
a process of trials and efficacy, side effects and everything
else. Food supplements are not required to go through that kind
of process. You are not comparing like with like, with respect.
The idea this is being pushed by the pharmaceutical industry to
put the health food shops out of business is not an agenda I recognise.
It certainly plays no part whatsoever in the policy formulation
or any discussion I have been involved in, far from it. I would
not go down that route.
298. But you can understand the anxieties of the health food
industry and them feeling that you are hitting them rather hard
when the larger multinationals are not being hit?
(Mr Rooker) I could understand that if they were a
bit more forthcoming with information about how they would be
affected. As I have already said, when I met industry representatives
and also those opposed last July I was given a figure of 4 per
cent for the percentage of the turnover of B6. During the course
of this process—and it could be argued one of the reasons
why it has taken so long—back in October we wanted to look
at the impacts on the industry because we are not seeking to snuff
out an industry, far from it. We wrote to trade associations on
7th November, asking for information on the costs of the impact.
We got some responses in December. In December again we contacted
the National Association of Health Stores and asked them for some
examples of small retail businesses which would tell us about
the impact on their businesses and they gave us the same day,
11th December, with the owners' agreement, details of three small
health food shops which would be, and I quote, "severely
affected by the proposed legislation and willing to assist".
We wrote to those companies. We wrote again in January. We sent
some reminders on 12th January. We have never had any responses.
They were businesses in Staffordshire, Cumbria and Kent; small
retail businesses in the health food industry. We are serious
about discussing the impact on an industry, going through a regulatory
appraisal process of so-called "damage which could snuff
out an industry" and "draconian measures" and we
have been open enough to say, "Give us the information",
but we have had no response. What conclusion do I draw from that?
I draw the conclusion that I may have been told a porky about
the effect on the finances of the industry and they cannot come
up with the goods. That is the natural conclusion I draw.
Mr Hayes
299. You say that, Minister—
(Mr Rooker) Say what?
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