Examination of Witness (Questions 300 - 319)
TUESDAY 19 MAY 1998
MR JEFF ROOKER
300. You say you have been told "a porky", to use
your term, but your own regulatory appraisal—and there are
some uncertainties about this—suggests there are some significant
economic impacts particularly on small retailers. As Mr Mitchell
has said, once you move diet supplements, which is what you are
proposing to do, out of the hands of food shops, which is what
health food shops are, and into the hands of pharmacists and doctors,
it will inevitably send shock waves across the health food industry.
If that trend were to continue, and there have been claims about
vitamin C's toxicity in large doses, for example, as you well
know, far more recently than Dalton and Dalton, what is the future
for health food shops? No wonder they are worried. No wonder they
are claiming you are draconian.
(Mr Rooker) With respect, John, the future is in their
hands. You ask me, "What is the effect on them", I am
asking them about the effect of this. They are not telling us.
Why is that? We have gone to the trade association, asked for
examples with their consent of those who will freely tell us how
they will be severely affected, we contact them on more than one
occasion to remind them, will you please tell us and they do not,
what conclusion do you reasonably expect me and others to come
to?
301. But your own appraisal, your own regulatory appraisal,
paragraphs 16 to 24, in the evidence you have submitted, suggests—and
I know this is uncertain because you have made estimates and I
do not blame you for that—there may be significant implications
of this. This is going to have an effect, is it not, on small
health food shops? It will have a damaging effect.
(Mr Rooker) The effect on small health food shops
can be best told to me, to this Committee, to the House, by small
health food shops. Telling us by pre-printed letters that people
send in to Members of Parliament, making a claim about the effect
on them, is not the same, to be honest, as giving us the pounds,
shillings and pence effect on their business at our request so
we can see whether or not we are going down a road effectively
that snuffs out part of the retail sector. That is not our intention.
That is the reason we have published the regulatory appraisal,
it is the reason we have given plenty of time, it is the reason
we have gone out of our way to talk to the industry, it is part
of the reason all this was happening over the winter—October,
November, December—long before we got to the point where
we had to publish the regulations and the regulatory appraisal.
I do not know, because they will not tell me. That is the bottom
line.
Chairman
302. I am conscious we are running out of time, but we got
some very straight answers to questions this morning from the—
(Mr Rooker) I hope you have had straight answers this
afternoon.
Chairman: We got figures when we asked them. I can see representatives
of the industry behind you and I am sure they will rise to the
challenge and provide you with the details. I hope they will,
anyway.
Mr George
303. You say you have not been given facts and figures, but
leaving aside the statistics, there seems to be an inconsistency
in that the Dalton and Dalton evidence seems to be out of range
with the other research. How do you respond to that?
(Mr Rooker) I know you have questioned Professor Woods
on that. I am not qualified to argue the toss between one paper
and another. The fact of the matter is, on the broad figures that
COT arrived at, which again I repeat were looked at by the Food
Advisory Committee, the Committee on Safety of Medicines, the
Medicines Control Agency, there has been no dispute. None of these
agencies have said to ministers, "We are not going down this
road, we are not going to do this appraisal, we are not going
to publish this regulation. Our best advice to you ..." and
that is what they owe us, their best independent advice, "...
is we advise you against it." But then you have to look at
what others have done, if you like, as a comparison. I have asked
the question what do they do in Europe? What figures do they use?
I had an open mind. I knew nothing about the industry. I knew
nothing about the effect and the importance of B6 to people. I
know about the importance of vitamins and making sure people have
a balanced diet, it is true, but when one then sees in Europe
we turn out to be other than Holland the most liberal regime and
as others look at this issue, as Professor Woods said this afternoon,
the more we came to the conclusion about the same broad limits
of where damage could be caused and we then apply a safety limit
as a precaution. You might argue that a five-fold limit for safety
is too great, that is a point of argument between us, but when
that comes to us as Ministers it is very difficult for us to second-guess
the scientists. So we are not looking, with respect, at one narrow
study. I know it is the one people will home in on but I refuse
to accept that the way Ministers have looked at this has been
down a narrow tunnel. We have looked at it in a very broad way
taking on board a range of advice from different regulatory authorities
between two Ministers and applying the precautionary principle
and I will repeat, because it needs repeating, being open and
transparent about where our advice comes from which is more than
I can say is the case for those who take a contrary view.
304. You can understand why possibly members of this Committee
and surely you also see it as rather curious that the study on
which COT's recommendation is based seems to be out of sync with
all other research and that clearly must raise questions and that
has been the cause of a great deal of debate here today.
(Mr Rooker) You are quite right that there is a scientific
uncertainty here. I freely admit that. I have to say that on the
basis that there are two factions of scientists and there is that
degree of uncertainty, then whilst I am the Minister responsible
for advising my Secretary of State and others I will say, "Let's
take a precaution on this until—"
Mr Hurst
305. Minister, can I follow up the point that Mr George was
making. You understand our difficulty very simply and you have
heard here today quite categorically that there is only one evidence
case based on human beings, that is Dalton and Dalton, published
ten years ago, seriously challenged, published I presume in English
but in a Scandinavian scientific journal, therefore I am not able
to judge peer group reaction to that. We have also been told that
the EU study was not taken into account when COT reached its decision.
The overwhelming evidence appears to be against the conclusion
that your advisory committee unfortunately reached. I can understand
your difficulty, Minister; my difficulty is I do not understand
these things. Insofar as I understand a little about evidence
I do not think you would convict any criminal on this evidence
at a trial. The evidence just is not there and yet it has far-reaching
effects for millions of people and a quite successful industry.
(Mr Rooker) You say successful industry but that is
not a factor that weighs in my calculation. I am not negating
what I said about the effect on health—
306. Can I delete that comment from what I said and just
leave the rest, Minister.
(Mr Rooker) Well then you raise the issue regarding—I
know nothing about the scientific community in Sweden and I do
not know if the document first appeared in Sweden. What I do know
is that within the European Union the United Kingdom takes a slightly
different view on the way these issues should be dealt with to
our European partners. That is well-known. The reason that Consumers
for Health Choice got started was because the European Union was
going down this road and they are going down a road with which
we do not agree. By fixing a percentage factor of the daily intake
that is required. We will not support that in the United Kingdom.
I have made that clear to the industry. We are at one on this.
We will only takes action based on the risk and the evidence of
the particular product. We will not go down the road of saying
it is three times the daily intake and that is the limit for evermore.
That is the way the European Union indicates they might like to
go. That is the way they operate in Germany for example and the
argument is yes they do that because they are sucking up to the
pharmaceutical companies.
Chairman
307. We have had fairly clear evidence this morning of a
scientific consensus that 500 mg per day is the lowest observed
adverse effect level and 200 mg a day is the no observed adverse
effect level. That seems to be a fairly clear consensus apart
from Dalton and Dalton.
(Mr Rooker) I do not know what evidence you have had
this morning; I am not privy to that. You have taken evidence
I understand this morning from the industry. You have got to make
a judgement.
Chairman: They are distinguished academics.
Mr Todd
308. Including a former member of COT.
(Mr Rooker) Yes but nobody who appears before this
Committee is going to be an undistinguished academic, whatever
side of the argument they are on. They are all going to be top-notch.
Chairman
309. Just like the Ministers!
(Mr Rooker) But they do not all tell the same tale.
There is a degree of uncertainty. I freely admit where there is
a degree of uncertainty I will go down the precautionary road.
That may be a consensus view that the Committee does not share
but I am giving you a view of the way the Government is operating
on this.
Mr Marsden
310. A very quick question on the yellow card scheme. I understand
it has been mentioned in letters from the public and also in a
Parliamentary Answer where you seem to have said that there have
been 410 adverse reactions associated with vitamin B6 over some
33 years. However, this might not necessarily have been caused
by vitamin B6. Again, that data does seem to be questionable as
to what is the actual root cause of this reaction, and I wonder
what your view is.
(Mr Rooker) I try to be—I say "try to be"—ultra-open
in answering questions both in the Committee and in written answers.
I probably add to every tenth one which comes across my desk,
to give more information, because I think it is important to be
open. I was asked about this and I gave the information we had.
You have to accept, of course, there is no surveillance system
for dietary supplements, period. There is not a system in place.
I have nothing I can go to as a resource to say, "What is
the problem with dietary supplements recorded through the reporting
system?" There is not one. These have come up over the years
more by accident than design. Some are spontaneously reported
and are true. Some of the adverse reactions are from a product
which has got B6 plus other products in it, so it is not homed
in on that, so you cannot be absolutely certain. I do not want
to worry you but over 33 years there were those, and I have to
say 16 of them were fatal, but I do not rest my case on that.
311. You are not seriously suggesting that vitamin B6 is
the cause?
(Mr Rooker) No, but you have quoted the figures from
the answer I gave. Between 1964 and 1997 there were 649 reports
of 1,181 spontaneously reported adverse reactions associated with
products containing vitamin B6, of which 16 were fatal; products
containing vitamin B6. I am not saying that B6 was the cause.
That is the reality. There is no filing cabinet, there is no drawer
of evidence, because there is not a reporting system for dietary
supplements.
312. I accept that but the fact of the matter is you are
pointing out this information and it is a fairly, you might say,
drastic inference to draw from that. I suspect that the 1,180
people had a cup of tea the day before and that could have been
the reason. What I am saying is that I totally sympathise that
the information is not there, but my point really is, how do you
envisage the future whereby in terms of dietary supplements there
is a more scientific approach for gathering data so there may
be a more strategic approach to this to then regulate this industry,
which I agree at the moment is perhaps open to question?
(Mr Rooker) I agree, where regulation is brought in
the regulation has to be monitored. There will be an opportunity
for, if you like, a more systematic approach to the adverse reporting
system, simply because the products with this high dose chemical,
taken in as a dose rather than as a food, will be, if you like,
within the medical fraternity and not within the food fraternity.
The medical fraternity has the yellow card reporting system. We
have it for other products—veterinary products. Where there
are medicines, where you have a regulation, you need to have these
reporting systems, and it will be covered by that. I do not rest
the case on that. It is no good saying, we have to give people
this because they will argue we are saying the yellow card system
is a justification, it is not a justification, the figures are
not used in terms of justifying the policy, but they are information
which people are entitled to have in the public domain.
313. I think you are in agreement that there is a lack of
information, that there should be greater systems and greater
scientific research into this whole area and you have indicated
that after the consultation process ends, it is open ended, you
are not going to prejudge it and say when any regulations may
be brought in. Would you be prepared to consider deferring the
introduction of any regulations until the Food Standards Agency
is set up when the appropriate committee could reinvestigate this?
(Mr Rooker) I think I answered Mark when Mark asked
that question about the expert group. As I am sitting here the
answer is no but I go back to the very first question I answered
of the Chairman; I am not prejudging the consultation. I do not
know in six weeks or after we have reviewed the consultation after
it is formally closed what view we will take on what evidence
we have been given. I do not know whether I will say to the Food
Advisory Committee, "Will you have a look at this again on
the basis of the evidence." They would be the ones to say,
"Yes, we will let COT have another look", or not. I
cannot possibly say yes or no to that. What I can say—and
I hope I have been clear in answering your questions such that
I mean what I say about this—is that we have prejudged to
the extent we are consulting on the COT advice and the Food Advisory
Committee advice quite clearly, but it is a genuine consultation
and at the end of it we will assess the position. As I say, I
have no fixed date. We are not running to a target. I have nothing
in reserve, as it were. We will assess the evidence and I think
that is an important thing to do.
Mr Mitchell
314. If you do go ahead with the regulations you will have
to harmonise B6 levels both as a health food and in medicines,
will you not?
(Mr Rooker) That is correct.
315. The licensing procedure for medicines involves an assessment
of risks and benefits and many of the side effects from licensed
medicines are actually more damaging than those produced by B6,
are they not?
(Mr Rooker) Yes there is always a warning on medicine,
even ones we buy from the pharmacy without prescription, saying
do not drive or do not drink alcohol. There are side effects to
things that do you good which are around us all the while. I do
not dissent from that at all.
316. Is there not a case for going back to industry about
the warning on the packet which you said was discussed earlier
and rejected by them now things have reached this pass and discussing
a warning?
(Mr Rooker) Well we did do that. I have not re-visited—
317. Things have come to a further pass.
(Mr Rooker) That is right but the fact is MAFF did
start off, as it were, grabbing this issue not "to snuff
out an industry and bring in draconian measures". The first
port of call, if you like, way before this Government came into
office was to talk to the industry about having some voluntary
warnings on the packages. That was not an acceptable route for
the industry. Nobody has come back to me by the way during the
consultation so far, which has not closed, and has said they have
changed their mind.
Chairman: I will let Mr Todd finish this session off.
Mr Todd
318. You have seen this as an issue about medicines and health
claims. Do you believe that there is a significant problem of
unsubstantiated claims by health food products of this kind because
this morning, to be quite honest, the industry said they did not
see it this way at all. They do not claim that these particular
things will solve your health problems.
(Mr Rooker) I take on board what you say. In fact,
we have got a box of I think it is about 250 samples of B6 we
have accumulated at MAFF over the last year. We have gone out
and said, "Where is this stuff sold? What form is it sold
in? What packaging?" because we had no background in this
obviously. I think we were running at 250 samples, it might be
more, when I looked at it. I understand today they just had a
check in a box of twenty and half of them had not got any what
we might call warnings on at all.
319. This is more what they claim positively to do rather
than what you—
(Mr Rooker) No, it is not, because the claims may
not actually be made by the manufacturers. I have cuttings in
the file and in the office where you are reading journals saying,
"This will do you good". I will not quote them because
it is unfair.
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