Examination of Witnesses (Questions 120
- 142)
TUESDAY 19 MAY 1998
Mr Maurice Hanssen, Mr Anthony Bush and Mr Derek
Shrimpton
Chairman
120. I wonder, Mr Hanssen, if you could, quite
quickly after this session, perhaps send us some samples of labels
that your members use.
(Mr Hanssen) Yes.
Chairman: Any promotional literature that is
prepared. We are under some pressure to do this report quite quickly
but if you could do that that would be helpful.
Mr Todd
121. Specifically I think on Diana's point,
any training material you provide for shop assistants in the health
food sector would be helpful.
(Mr Hanssen) Yes.
Chairman
122. Time is of the essence because we are up
against the Government deadline for consultation on the Statutory
Instrument.
(Mr Hanssen) Yes.
123. I come back to you: you call yourselves
the Health Food Manufacturers' Association, a health claim is
implicit in your product, is it not?
(Mr Hanssen) Shall we say a choice of ingredients
is implicit in the products. Quite a number of our 150 members
in fact make food, including special foods, but really the use
of artificial materials is something which they do not want to
do and neither in fact do most of the tablet manufacturers and
others. We are looking for purity, we are looking for quality
and so it does not arise.
124. You make claims that implicitly it leads
to a healthy lifestyle from the consumption of much of your products,
including B6. If you are making claims about health is it right
to expect to be exempt from the scrutiny of the medicine regulations?
(Dr Shrimpton) Could I please answer as a nutritionist.
The Health of the Nation which has been subscribed to by both
the last government and present government has a very large component
of nutrition in it. One of its recommendations indeed is to be
healthy you need to have five helpings of fruit and vegetables
a day. It is not defined precisely what these are and it is not
easy for the 80 per cent of the population who are urban to obtain
it. Nevertheless that is the main claim. It is implicit that if
you eat well you will be healthy. In this context there is no
difference between health food and any other food, the difference
lies in the proportion between which you use them. That is not
a matter of every meal and not even every day, it is a balance
that frankly we do not know. We hear a balanced diet trotted out
but I do not think any of us yet know what that is in terms of
is it a balance a day, a balance a meal, is it a balance for a
week, is it a balance for a year? Most of us work on the basis
that it is a balance for a week because that is the easiest way
of living comfortably.
(Mr Hanssen) I have got a plan to write a book at
some stage called "The Myth of the Well-Balanced Diet"
but I have not got enough information to make it helpful!
Chairman: Let us go on to the Dalton and Dalton
study.
Mr Hayes
125. I am going to put some questions to you
which are very similar to the ones that we put to the Consumers
for Health Choice and their scientific team on COT's recommendations.
COT acknowledged "methological deficiencies" in the
Dalton and Dalton study, but claimed that it could not be ignored
"in the light of other supporting human and animal data."
Professor Woods says in a memorandum to us that "it is the
nature of risk assessment that the review of the totality of data
leads to the use of one or two critical studies for the determination
of safe doses." Regulation has to be based, however, on the
lowest observed adverse effect level, does it not? Even if there
are certain deficiencies in the study, does not the "precautionary
principle" dictate that COT and the Government are right
to safeguard against a potential threat to human health? In other
words, are not the Government simply being sure and safe and taking
precautions in the public interest?
(Mr Hanssen) The answer is no and Derek will explain
why.
(Dr Shrimpton) The problems which you raise are real
problems. I have certainly had the benefit of discussing this
with several members of COT not only on this occasion but as a
broader issue. First of all, you have to obtain as well as possible
a complete review of all the literature that has been published
and that is clearly an ideal which cannot be achieved. So you
will attempt to do it in the major papers that are available and
focus on those of the last ten years. Dr Dalton would come into
that in both categories. Her paper was unusual in that it was
the first report after the very detailed studies in the States
which appeared to suggest that Schaumburg had not, in his titration
study from low levels to high, observed a problem. The issue really
was whether it was a problem caused by pyridoxine or a problem
caused by something else. I think at the time COT met that question
could not be answered. It certainly was not in the literature
which COT reviewed. There was no answer provided in that literature.
They had a paper that was within ten years of when they were meeting
that was at variance with the literature that had gone before
it. One might say that there were two papers because Dr Dalton
published in the Lancet a letter and that letter was flagged
up by another British researcher whose arithmetic was untidy,
which annoyed COT, but he said that if this is right then it is
very important we must see more about it. Dr Dalton followed this
two years later with her paper in a Scandinavian journal. The
next thing was a massive surprise, ie, nobody followed it up,
neither Dr Dalton nor anybody else. We have heard from the previous
group what the comments are about the methodology, but the fundamental
point is it existed in print. We have to respect what she observed.
What was the cause of the observation? This became available later
and was first reported in the United Kingdom in a symposium last
September at The Royal College of Physicians by Professor Bernstein.
The characteristic of the pyridoxine neuropathy, ie, the nerve
damage, is that it starts in the hind limbs of an animal or the
legs of a human being and it works upwards and the last thing
you get is the face and the one before that is the hands or the
forelimbs. Dr Dalton's observations went in exactly the opposite
direction. The most plausible cause in her observations is that
it was not pyridoxine, it was something else. Neither she nor
anybody else had a chance to repeat her observation, we will never
know if that is the true explanation of it but it does explain
to many, first of all, why did she make the observations and,
secondly, what might have been the explanation of them. She was
not observing pyridoxine so her observations were not at variance
with the literature, she was observing a new facet. I think we
need to find out what that new facet was but it was not pyridoxine.
Pyridoxine, we have heard many times this morning, is very well
described and defined and it is defined also in the work quoted
by Phillips and Munro of exactly how the dog data worked too and
why Phillips and Munro did not think that was appropriate to use
for humans because there is an adequate amount of human data.
(Mr Hanssen) It is worthwhile mentioning the latest
thing just published on 7 April, which we heard about earlier,
from America which has set their new RDAs and safe levels for
the B vitamins from their National Academy of Sciences Institute
of Medicine, an immensely powerful and respected expert group.
They say about the Dalton paper at the end of their review of
it: "In summary the weaknesses of this study and the inconsistency
of the results and the weight of evidence pertaining to the safety
of higher doses of pyridoxine rule out the use of this data to
base an upper limit". You say you have to take all the data,
I think you have to take all the relevant data. What many experts
are saying worldwide is this is data, no-one doubts that Katharina
Dalton observed what she observed. This is not a matter of doubting,
it is a matter of causality. This expert group on April 7 has
added that.
126. That is what Dr Marks said earlier. He
made almost the same points about not criticising the quality
of her observations—
(Mr Hanssen) Not at all.
127.—but the link.
(Mr Hanssen) She is a very sincere lady.
128. What is the supporting animal/human data
that COT referred to? You seem to be suggesting that subsequent
research was actually, I will not say contradicted but throws
some doubt on the conclusions of Dalton. COT talk about supporting
data.
(Dr Shrimpton) The supporting data which COT used
was also data which I think Dr Marks referred to of Professor
Parry of Minnesota. He had 16 individuals in his study with a
range of intake of pyridoxine from 200 up to I think two grams[8].
The difficulty is that he did not actually know how much any of
them took because they were all free living but that was about
his range. You heard that the most difficult one of all was the
low level one. Even in Parry and Bredesen paper they say they
are uncertain about the intake of the lowest level. Once you go
to the high levels it may be they took one gram and not two or
they took three grammes and not two but the argument is not relevant
then in that level. That was the only other human data, and that
is the only other human data on record at these low levels. The
other supporting data of COT relates to the use of pyridoxine
to overcome poisoning from a gluttonous intake of mushrooms which
was successful, surprisingly, and that was in massive amounts,
137 grammes in one case was put in straight away. The patient
did not die, which is a surprise, but they did get a neuropathy
and they were going to die from mushroom poisoning if they did
not. The purpose of their mentioning that was that it was unequivocal
evidence that at very high levels it was toxic, there is no problem
about that. The other evidence then was where should the level
then come and that was taking the data of the Phillips study with
dogs. Unlike Dr Marks the authors of that paper maintain that
the metabolism of pyridoxine by the dog is essentially similar
to the human. On that basis they maintain first of all that it
is not appropriate to use a divisor of ten when talking of 3,000
mg as equivalent to the human they used. Secondly, they were observing
a lowest observed adverse effect, not a no observed. So they do
not believe it is appropriate to use a divisor of three which
is the conventional way. These are rules of thumb but you are
dealing with orders of magnitude and that is part of how it works,
or does not work as the case may be. You then have 30 to take
out of that 3,000 and then you have to make a judgment as to what
variation you think there will be in the human population from
your level and that would come out to 100 I think.
129. Finally, you have not talked about the
precautionary principle which I mentioned in my question. Do you
believe that that should guide public policy in this respect?
(Mr Hanssen) 200 mg would seem to be scientific and
100 mg would be negotiable.
Chairman
130. What do you make of the follow-up work
done by Dalton?
(Dr Shrimpton) It really has the same characteristics
and I do not mean that in a disparaging way. It is a follow-up
by remote control, so to speak, of free living people which is
a very proper thing but it has many problems because you do not
know what the causality is. That is at the core of interpreting
the Dalton data. The causality would appear not to be pyridoxine
but something else. So her follow up does not answer the question
of causality. I think the follow-up work of Professor Bernstein
does quite clearly explain the causality, drawing attention to
the original observations of Schaumburg and repeating them in
some considerable detail. I do not have any doubt about the nature
of the neuropathy and the cause of it and you actually have to
make that microscopic examination of the nerves, you have to observe
it from the feet upwards and so on. So it was quite clearly different
and I think her follow up confirms that statement.
(Mr Bush) Whilst Dr Dalton looked at 20 subjects,
we asked 1,671 people about their responses to vitamin B6 and
in that we found, as was previously mentioned, about seven per
cent of people had tingling in their fingers. We did not say in
the questionnaire, "Do you have tingling in your fingers?"
We said, "What sort of things do you experience when you
take vitamin B6?" and they put that down. When we asked a
controlled group of 2,000 non-vitamin B6 users what sort of things
they experience in life, we found eight per cent of people experienced
tingling in their fingers.
131. So vitamin B6 cures tingling in the fingers.
(Mr Hanssen) Whatever. The advice that supports the
Bernstein work and the survey that we did is new evidence which
has not been looked at by COT and I would suggest there is enough
in there to question whether the decision was made with enough
evidence.
Mr Hurst
132. I want to go back to the question of the
support of human evidence which I understand comes from Professor
Parry in Minnesota. Am I right in saying the sole amount of that
evidence on low dosage is a telephone call to one respondent?
Is that seriously what you are asking us to believe as scientific
evidence?
(Dr Shrimpton) One of the difficulties is that that
was a short paper publishing a clinical experience. One should
not criticise Professor Parry for not doing what Professor Schaumburg
did, which was a very detailed study. The difficulty comes when
one wants to use it in a regulatory sense. You are absolutely
correct, that is what happened. There were 16 people, only one
of whom was at the lower level. It was a phone call and the individual
concerned did not know what he had actually taken, although he
was supposed to be the low level one.
Mr Hurst: I do not want to be tiresome about
scientific research, but I do not think anybody else could proceed
in a manner where you are basing judgments on one telephone call
and publishing it. It is, frankly, beyond our wit.
Chairman: I am not going to invite a response
because I promised Mr George he could have some questions on that.
Mr George
133. I will come to the nub which is really
following the point that Mr Hayes was raising a moment ago about
the precautionary principle and your interpretation. Mr Hanssen,
you said that the burden of proof is upon MAFF to show the causal
link between B6 and—
(Mr Hanssen)—the Dalton effects.
134. Yes. As the Health Food Manufacturers'
Association do you not take a view about, for example, the pesticide
residues in food as well. Where does the precautionary principle
apply there?
(Mr Hanssen) There are two sorts of things. That which
you eat is desirable at one level or another, it contains nutrients
which are part of the evolutionary requirements of you and I.
Pesticides, artificial colours and preservatives and such like,
are really only there for convenience, not for our nutrition,
therefore the way in which one looks at them—and one is
used to looking at things very expertly in this area—is
to wear belts and braces and have them in safety. With a nutrient
which you need otherwise you are ill, to make these very large
divisions of say 300 is just not appropriate and not nutritional.
135. Do you believe that MAFF have got their
recommendations or their statutory levels right with regard to
the pesticide levels in foods?
(Mr Hanssen) With regard to pesticide levels in foods?
136. Pesticide residues.
(Mr Hanssen) Yes. There are certain things here where
even the EU are deeply worried. For example, many of the lettuces
we get from Spain and Italy are grown under a continual spray
of pesticides and so on in polythene tunnels and we think that
some of these could be much too high.
137. You would take a very strictly precautionary
principle with regard to that?
(Mr Hanssen) I would to substances foreign to the
body.
138. In the case of B6 the recommended level
is 1.2 to 1.4 mg a day?
(Mr Hanssen) No, that is a level designed to prevent
a deficiency. We do not know what the optimal level is. It is
rather like the folic acid thing, 200 mg prevents deficiency,
400 or it might even be 800 is moving towards the optimal. We
know so little about that. That is why we need to be based on
safety principle rather than on the principle of what prevents
deficiencies. It is a different nutritional concept and one that
is becoming very important, for example vitamin E and the antioxidants.
139. And it varies from person to person?
(Mr Hanssen) Safety does not seem to vary that much,
probably the need does. If you look, for example, at toxicological
problems, traditional medicines and food supplements, which is
the last big thing, B6 is not mentioned. It is easy and facile
to say this is because nobody has reported it properly. On the
other hand, there is a hell of a lot of other things in there
which people have reported. One can say there is quite an awareness
that if you are feeling things going wrong you try and find a
cause and big things would have come out. We do want to take a
prudent view but not one that denies people the freedom of choice
of something they have been using since the Dalton and Dalton
paper came out as well with nobody saying a word and nobody getting
worried about it.
Mr Marsden
140. One final one. Following the US National
Academy of Sciences Report where it erred on the side of caution
and came out wit a recommendation of 100 mg per day as a limit,
would the industry be prepared to accept a voluntary 100 mg a
day limit or would it have to be introduced by legislation?
(Mr Hanssen) I believe that we could 99 per cent enforce
it and even go one further because I think I would not have any
trouble with my colleagues in persuading the retailers to enforce
it. We are talking, of course, with these upper levels about products
for over the counter free sale, for self-selection. There is always
a place for practitioners and doctors who want a higher level
product with a direct contact with somebody to make it for them.
If we are talking about things for self-selection, I believe that
we can persuade it by discussions both with the retailers and
the manufacturers. If the retailers do not accept it then nobody
is going to sell it.
Chairman
141. You did have to kick one member out of
your association for a 250 milligram sale.
(Mr Hanssen) Yes, in the past two years for one reason
or another we have kicked three members out of the association,
all of them substantial companies. That really is a prelude for
us to inform the authorities because clearly reform comes before
retribution. We want to try and reform people. We have not got
a great deal of strength with the retailers I have to say.
142. Thank you very much indeed, Mr Hanssen.
We are greatly appreciative of this session. Thank you for spending
your time with us.
(Dr Shrimpton) One very quick point. The comment was
made why had not the Nutrition Society responded. As a former
member of the council I would say we have no mechanism for making
such a response. With the classic case of the Minister of State
withdrawing milk from school foods we decided we had no means
of expressing our wrath.
(Mr Hanssen) From a legal point of view, from within
the EU there is, in making new laws, the concept of proportionality.
The law has to be proportional to the problem and I would suggest
that the proposals as at present tabled fall down on the concept
of proportionality.
Chairman: We take note of what you say, Mr Hanssen.
Again, thank you very much indeed.
8 Note by Witness: and 5 grams in two cases. Back
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