Examination of Witnesses (Questions 63
- 79)
TUESDAY 19 MAY 1998
Mr Maurice Hanssen, Mr Anthony Bush and Mr Derek
Shrimpton
Chairman
63. Mr Hanssen, welcome to this second session
of our inquiry into vitamin B6. I wonder if would you like to
begin by introducing yourself and your colleagues with you.
(Mr Hanssen) I am Maurice Hanssen, President
of the Health Food Manufacturers' Association. With its inception
in about 1965 this was an honorary job, which now gives an honorarium,
but it was honorary to start with. I am also Director of the Council
for Responsible Nutrition, and President of the European Federation
of Health Products Manufacturers' Associations, which represents
associations from 15 different countries within the EU. I also
have a background in safety in that I wrote a book called E
for Additives which set the scene from a consumer point of
view. I do believe in our business that if we do not do that which
is good for the consumer, we are not doing anything useful at
all. That is a greatly important thought. On my left is Anthony
Bush, who has been Chairman of the Health Food Manufacturers'
Association for some time, and is also the marketing and sales
director for Peter Black Healthcare, which has brands ranging
from herbal medicines like Heath and Heather, Healthcrafts vitamins
and so on. He has a lot of experience in the statistics and information
on the trade and, indeed, on the self-policing we have been carrying
out for many years. On my right is Dr Derek Shrimpton, who is
an independent consultant with nutrition and food science, and
who has often helped us over many years, especially in the work
we have been doing, (again over many years), on the safety of
nutrients. This (indicating) is his latest editorial publication.
It is very important to remember that we believe as much about
the safe levels as anybody else. To have things on the market
which are not appropriate is a big mistake. One of our problems
is a lack of enforcement for what we perceive as being rogue products
that occasionally come in from funny places, when the law is clearly
being broken and when we report it nothing happens. We are not
short of law, we are short of enforcement.
64. Thank you for your introduction and for
your philosophical statement. We are grateful as well for your
written evidence, which is particularly consonant today; but also,
Mr Bush and Dr Shrimpton, you also provided the Committee independently
with written evidence, for which we are very grateful. Inevitably
we will go over some of the same ground as we did with our previous
witnesses, as I am sure you will understand. First if I could
ask you, Mr Hanssen, to tell us a little bit more about the HFMA
itself; the sort of products your members produce; how important
vitamin B6 is within their range of products, especially in tablets
above 10 milligrams. Also, taking a point which Mrs Organ was
making earlier in questions, the size of the companies who are
members of your associations who are involved in the market place.
(Mr Hanssen) I would like to speak on behalf of two
associations in this context, the HFMA and the Council for Responsible
Nutrition. Between them they represent 95 per cent of the United
Kingdom production of nutritional supplements.
65. By volume or value?
(Mr Hanssen) By volume. They both subscribe to guidelines
for good manufacturing practice and for honesty of claim and safety,
so they have a communal interest which we are hoping to represent
today. We have about 150 members ranging from non-public companies
to large multi-nationals, but not very large multi-nationals.
The vitamin industry itself is worth—the supplement industry
all told, not just vitamins and minerals—somewhere between
£340 and 380 million a year, which sounds a lot to you and
I who do not earn that much, but when you come down to what it
means in reality it is about 50 per cent more than the turnover
for Kit-Kat bars. I think that puts things into some sort
of perspective. The Council for Responsible Nutrition is a much
smaller organisation in numbers of people but includes the really
large companies like Boots and Hoffmann la Roche and Seven Seas.
There is some double membership but very big companies have tended
to gravitate to the CRN so that they can provide the resources
for doing the sort of work we are doing on safety.
(Mr Bush) If I may make one point on the size of the
companies, to give you some idea. We are number two in the market,
Peter Black Healthcare, and we turn over £44 million. That
must be compared with the capitalisation of a pharmaceutical company
such as SmithKline Beecham of something like £40 billion,
so there is a significant difference here. Whilst we are very
pleased with the size of our company, we are small compared with
the pharmaceutical companies.
66. You are number two in the market?
(Mr Bush) Yes, we are.
67. And you are a British company?
(Mr Bush) We are very much British, based in Keighley
in Yorkshire.
68. You cannot be more British than that! How
important within the industry is B6 as a product?
(Mr Hanssen) Much more important than we thought before
all this blew up. B6 itself has hardly been promoted. You cannot
make a medical claim for it. Interestingly, there are not any
products licensed by the MCA for the sort of indications and uses
that have been talked about. The only licensed products are for
use in conjunction with the treatment for tuberculosis which is
not surprising. So we did not expect it to be that big. There
are two sorts of products: those with vitamin B6 as their only
or main ingredient, and those which are a combination product,
which are quite large. Anthony has the answers to that.
(Mr Bush) Over 10 milligrams, the market is worth
around £35 million. Of that, £25 million is represented
by combination products, single vitamins are about £10 million.
We would also like to mention that under 10 milligrams there is
another market as well, but the market we are talking about is
over 10 milligrams.
69. How big is that market for under 10 milligrams?
(Mr Bush) About £71 million. The reason is that
they tend to be multi-vitamins and most of our multi-vitamins
have vitamin B6 in them, in some shape or form.
70. We have heard evidence earlier today about
the availability of the market of products over 200 milligrams.
I think there is only one product in the United Kingdom which
is 250 milligrams. Is that your understanding as well?
(Mr Hanssen) That company we asked to desist. Quite
quickly we had to take them out of membership because we do not
believe that 250 milligrams is suddenly very dangerous and 200
is not—that would be an extrapolation—but once having
made a standard and having got an upper safe level, if you cannot
get industry agreement you have to separate yourself from anybody
who does not comply. The same sort of thing happened with other
vitamins. We happened to have agreed with MAFF and the Department
of Health a long time ago that above the RDA levels on vitamin
A, products should carry a warning to people who are pregnant
or who might become pregnant. Interestingly, this was triggered
by the problem with high levels of vitamin A in liver. At the
time this came into being, this thing on supplements, there was
a lot of publicity from MAFF about the dangers of eating liver
and vitamin A. Whereas that warning has remained, any information
to the pregnant about liver has entirely disappeared. One needs
to look at the total direction in the context here.
71. We heard evidence the other day about above
500 milligrams being a dangerous level for B6. Do your products
contain warnings not to take double or treble doses, to take you
close to or above that threshold?
(Mr Bush) Invariably our products will say, "Please
keep to the recommended intake."
72. Would it suggest that there is a reason
for doing that? What would the wording of those warnings be?
(Mr Bush) We do not suggest that, no.
(Mr Hanssen) We are beginning to implement it on iron
although the only dangerous effects that we can record are mostly
from medically prescribed iron, where a one-year-old or two-year-old
picks up the pot and eats the lot. We have a voluntary agreement
now with all the three main trade associations to put on iron
warnings. Indeed, this was not a Ministry initiative. It was an
initiative within the trade. That sort of thing, when we know
there is a real danger, we have no problem in coming to an agreement
about it.
73. But you do not draw the attention of the
consumers to the fact that there is clear evidence of danger above
500 milligrams?
(Mr Bush) Not at the moment, no.
(Mr Hanssen) We would say, "Stick to the recommended
dose."
Mr Hurst
74. May I follow the question the Chairman raised
about the 500 milligram danger level. I understand that comes
from Schaumburg's investigations. Could you tell me what the nature
of those investigations were and how wide-ranging they were.
(Dr Shrimpton) They were the most authoritative studies
which have been carried out, with the exception of Bernstein's
studies which were carried out some 15 years later. In the case
of Schaumburg they were full neurological studies, complete. They
were with a small number of individuals. Of course, if you are
going to study in detail and meet the criticisms that Katharina
Dalton met, for example, either you do this with very, very large
numbers of patients—and we are now used to clinical trials
of 10,000 plus, very difficult to carry out and obviously not
many of them—or you have a relatively small number, usually
smaller than 50, where you can carry out the study in complete
detail and in total control. That was the nature of Schaumburg's
studies; so that not only was he able to make the observations,
but he was able to have some understanding of what was happening:
why was the finger tingling? for example. The finger was tingling
because there was damage to the nerves, and you could measure
exactly what it was. The next question was: was that damage permanent
or temporary? Schaumburg established that it was temporary at
500, which is a rather important thing. You are in a gradation
here, as was mentioned earlier, from danger when you have too
little, to a happy period somewhere around the middle area, to
a period where things start to go wrong again. As they go wrong
they get worse and worse. You come to a point between 2 and 3
grams where it turns to damage, which cannot be repaired, (usually
about 2 grams), so that is the spread. You have it from 1 milligram
or less being dangerous, up to 200 being clear. Very few people
looked at the gap between 200 and 500, so we do not know what
happens there. At 500 you start to get signs of things going wrong.
That is one of the important things in a nutritional situation,
you take the sign and you work below that sign. What you then
do is to go back to the next area where you have positive safety.
The gap then remains your safe zone, if you like, but you do not
go into that zone.
75. So Schaumburg is generally accepted as an
authoritative study?
(Dr Shrimpton) Yes. Schaumburg was the first person
to identify this syndrome.
76. Does he therefore count both ways in that
over 500 is perceived to be dangerous? Under 200 is perceived
to safe?
(Dr Shrimpton) Over 500 is perceived to be where things
start to go wrong. Over 2 grams, in Schaumburg's statement, is
where it is dangerous because it is irreversible. Between 500
and 2 grams you have a reversible position. If you stop taking
it you get better. From 200 downwards there is no evidence of
any problem until you get below 1. Then you have a problem.
77. This is Schaumburg's count at below 200?
(Dr Shrimpton) Yes.
78. I wonder if we can now move on to something
less scientific. What is the average retail price of B6 products?
(Mr Bush) My company sells 50 milligrams of vitamin
B6, 60 tablets at £3.69, 30 tablets of 100 milligrams at
£4.09, all under the Healthcrafts name. If you wanted to
look at multi-vitamins which is a lower dose, then you would be
paying about £2.45 for 30 tablets. All these prices, as you
can see, are well below the prescription price of £5.80.
79. We have had evidence from Dr Shrimpton that
approximately 1 million women take tablets, which tend to be between
50 and 200 milligrams, for a few days each month in connection
with PMT. Do you know of evidence that in fact there is continuous
use, notwithstanding that it may be unnecessary?
(Mr Bush) The industry asked for an independent survey
to be carried out just as this whole thing blew up. In fact, we
asked for it to be carried out before this inquiry came up. An
independent survey company wrote to 10,000 women, who were known
to take B6, asking them a number of open-ended questions about
their taking of vitamin B6. Of the 1,671 replies we found that
there was a spread in two ways. First of all, a spread of why
they were taking this product: everything from mood changes to
feeling better and having a feeling of well-being. We found that
some men were taking it as well so we discounted PMS for that
reason. Once we had that information and analysed it, we also
found that there was some continuous use, clearly of about two-thirds
of the people. Then there were other usages across the spectrum.
|
