Examination of Witnesses (Questions 740-759)
DR GILL
HART, MR
RICHARD GUTOWSKI,
MS HELEN
YOUNG AND
MR ANDREW
DILLON
15 MARCH 2007
Q740 Chairman: You did speak about
people being able to go on the Internet and get things from Holland
and so on. Are there European regulations in this area?
Dr Hart: This is the European In Vitro Diagnostic
Device Regulation which is what we incorporated into the 1987
Consumer Protection Act.
Q741 Chairman: Is your implication
that the European regulations are not as tight as the UK ones?
Dr Hart: There is confusion within different
competent authorities within Europe, my understanding is, of how
the regulations are interpreted and even within the notified bodies
within the UK.
Q742 Baroness Perry of Southwark:
Can you explain to me as a lay person how the IgG food allergy
test works, given that people who are not allergic to specific
foods can still produce an IgG antibody response when they eat
those foods?
Dr Hart: I think when we consider the antibody
response to an antigen challenge we need to really think that
the antibody response is only the first part of the whole reaction.
The presence of antibodies, and this I believe is true for IgG
and IgE, does not necessarily mean disease or no disease. What
does make a difference is the complex cascade of events that occurs
after the antibody has been raised and what we find is that we
use the IgG as a marker that a reaction has occurred, but that
does not necessarily mean that the reactions could provide a cascade
resulting in disease. We know that the mechanisms for this are
unclear and as a company we have tried to support and collaborate
with groups to find out more about these mechanisms. Indeed, we
have provided tests to a leading London hospital who have now
shown, and this is evidence that is going to be presented in Digestive
Disease Week in Washington in May, that in inflammatory bowel
disease there is significantly higher IgG titers than in normal
groups and this is the first time this has been shown. In addition,
the group has also shown independently, using our test, that people's
reported food sensitivities, i.e. filling in a questionnaire saying
what am I sensitive to, correlates very very well with the IgG
levels and this is particularly in ulcerative colitis. It is very
preliminary research and it is something that we really hope the
team at this London Hospital will build on. We have struggled
working with others to get grants to do this sort of work, but
we really want to encourage the understanding of these mechanisms
which we know are not yet clear.
Q743 Baroness Perry of Southwark:
How often do you find negative results?
Dr Hart: Yes, of course. We provide a food intolerance
indicator test. Bear in mind that the people that come to York
Test have chronic conditions. Our recent survey data, which we
published, showed that over 70 per cent of the people have suffered
for more than three years with their condition, so it is not a
normal population that comes to York Test. What we find is that
between 75 and 80 per cent of those people will have at least
one positive scoring to one of our 113 foods.
Q744 Baroness Perry of Southwark:
Perhaps I could ask the other members of the panel, I understand
that the IgE antibody tests are an established part of NHS diagnostic
routines, is there any evidence to support the use of IgG antibody
food tests?
Mr Dillon: I am sorry, I have no information
to answer the question. NICE has not looked at that particular
area.
Dr Hart: For me, to support the use of IgG test,
yes there have been independent clinical trials which have been
carried out and published. This key one, is the double-blind placebo
controlled trial published in Gut in 2004 by Atkinson,
which was an independent study but used the York Test test. There
has been a study recently published in Nutrition and Food Science,
another in Headache Care and, indeed, the recent study
that has been carried out using the York Test test commissioned
by Allergy UK, and independently audited by the University of
York, used by 5,286 of our consumers has shown that people who
rigorously adhere to our diet, three out of four of those people
are showing some benefit to their chronic conditions, so a considerable
amount of data. We know ourselves as a company that we do not
do a lot of aggressive advertising, we cannot do that and the
company has grown mainly on word of mouth because people are showing
benefit and we see every day that there is, as we know, unmet
need, and people are suffering and are then seeing benefit by
using our service.
Q745 Lord Soulsby of Swaffham Prior:
Can I be clear that with these tests you are measuring the molecules
of IgG, you are not measuring specific IgG or IgE, are you?
Dr Hart: We are measuring food specific IgG
in our IgG tests.
Q746 Lord Soulsby of Swaffham Prior:
When you say, "food specific", what foods are you looking
at specifically?
Dr Hart: We have a range of different services
but the main one is 113 different foods. The test that we use
is an Elisa test methodology, so you can imagine that purified
food preparation put onto one of our Elisa plates is a mixture
of proteins, of course whole milk will be a mixture of different
proteins. Unfortunately, in our business it is not like measuring
thyroid function test where you have got a beautiful international
reference preparation, all laboratories are controlled, you know
exactly what they are measuring, you know the normal ranges, we
have not got the luxury of our higher order standards, the international
reference preparations. So that putting the foods on the plate
we have got a wide range of fruits, vegetables and the key foods
on the plate, that is what we use.
Q747 Lord Colwyn: I do not particularly
want to concentrate on Dr Hart all the time, and I apologise to
the others, but you mentioned the report commissioned by Allergy
UK, we have got a copy of it here, I wonder if you could tell
us if it is published? Is it being shown in a professional journal
yet?
Dr Hart: It was published at the beginning of
February in the Journal of Nutrition and Food Science.
Q748 Lord Colwyn: You talk about
"chronic medical conditions", but it is quite unspecific.
Dr Hart: That is the interesting area in terms
of the type of people who come to York Test with chronic conditions.
As you can see from the paper it clearly outlines the different
sorts of conditions that people do come with and because I understand
that in the medical community people are used to looking at specific
conditions, it is very difficult to sometimes understand the concept
that one or two different factors like removing food from the
diet could benefit a range of conditions.
Q749 Lord Colwyn: I think that a
lot of conditions will get better with a better diet and that
is of concern.
Dr Hart: That is true. What we do find is that
specific combinations of foods do show more benefit rather than
removing the typical foods that you might imagine are particularly
responsive to allergy and it is those particular combinations
that we can identify using our test.
Q750 Baroness Perry of Southwark:
Do you ever find that there is such a wide range of IgG reactions
when you do your tests that the person who sent the kit in is
almost on a starvation diet?
Dr Hart: We are very, very aware of this and
as you are probably aware we do provide a nutrition consultation
with our service. We do find people who have a high level of reactivity,
say greater than 10 different foods, in our test. We treat this
with extreme caution and we always talk to that customer and talk
through about how they may want to prioritise. We never advise
removing lots of different foods from one's diet, that is very
irresponsible, but we would suggest that they prioritise and maybe
take some of the ones that have had a particularly high titer
out from the diet first and see whether that benefits. In the
end this is an aid to management of diet and it is a little route
map rather than going through the laborious trials of elimination
diet and challenge which are maybe never going to find the exact
combination of foods that people are intolerant to. This is an
aid to management of diet and a route map through for the consumer
to help them.
Q751 Baroness Platt of Writtle: How
do the medical devices regulations and medicines licensing legislation
regulate the production and sale of allergy testing kits?
Mr Gutowski: I would stress at the outset that
the medical devices regulations simply regulate the testing kits
if they are placed on the market as an IVD. The Medicines Act
will regulate the kits if they are placed on the market as a medicine.
The two sets of legislation do not regulate in any way the service
provider or the treatment regime. There are two avenues. If it
is placed on the market as a medicine, that is normal—the
skin prick test—and they are prescription only medicines,
they must meet all the requirements of the Medicines Act in terms
of safety, quality and efficacy. If the kit is an in-vitro diagnostic
device, that is a medical device and it must meet the requirements
of the medical devices regulations. The two regimes are very different
in that if the kit is a medical device the manufacturer must be
able to substantiate his stated claims for the product in terms
of safety, quality and performance and must provide the data to
substantiate that. The kit that is placed on the market as a medicine
must have a licence under the medicines Act granted by, in the
UK, the MHRA. If it is placed on the market as an IVD, the regulations
are slightly different in that the manufacturer affixes a CE mark
of conformity, having gone through the various processes laid
down in the regulations. If it is a highly critical test, he must
have an EC certificate of conformity from what is called a notified
body. That is, a third party independent certification organisation
and they are designated by the competent authorities in each Member
State. Unlike the medicines legislation, the medical devices legislation
is based on mutual recognition so a manufacturer based in Greece
can CE mark his test kit in Greece and that has access to the
European Community. Each of the notified bodies is designated
for competence in this area of allergy test kits. They must prove
to their designated authority that they have the competence to
assess those kits. I am informed that there are 80 notified bodies
across Europe, but only 18 of those have the competence to deal
with allergy test kits.
Q752 Baroness Platt of Writtle: Allergy
tests using techniques such as hair analysis and electromagnetic
field detection, we understand, are not covered by the medical
devices regulations. Do you think that the scope of the regulations
should be broadened to include these products too?
Mr Gutowski: I am not too sure as to why they
are not included. If they meet the definition of a medical device
and an IVD, they would be included under the regulations.
Dr Hart: There seems to be confusion still as
to the provision of a kit that somebody uses at home to interpret
results and a testing service. What we are talking about is Vega
testing and others. Those are not kits that people have at home
or use and interpret the results on their own. They go into a
shop or a clinic and have that service provided without the aid
of a health care professional. That is the area that there is
confusion over at the moment. My interpretation of the IVD Directive
was that testing services were covered by the IVD Directive for
self-test and that is how I have put through our compliance, but
it is quite clear that that is not happening. This is not being
policed and I think it is very important that it is regulated
in future.
Q753 Lord Colwyn: Anybody who provides
a self-testing system or a system that goes off to be analysed
and charges money for it will eventually come under the scrutiny
of the press. I remember my friend, Stephen Davis, who used to
do hair testing, having terrible trouble with apparently two lots
of hair from the same person producing totally different results.
Has this happened to you? Is it likely to? How do you cope with
it?
Dr Hart: Yes, it happens to us. Essentially,
we comply with the essential requirements of the IVD Directive
which is all to do with fitness for purpose. It includes looking
at analytical performance data of specificity, reproducibility,
cross-reactivity and sensitivity and, from my point of view, also
clinical efficacy because I think not all IgG tests are the same.
There is a very fine balance between the positive and the negative
and whether they are measuring specific or non-specific binding.
It is very important that there is regulation. We do comply with
essential requirements of the IVD Directive and under that we
have to look at reproducibility. Yes, we have been scrutinised
and questioned about this but we have evidence to show that our
test is reproducible.
Q754 Lord Colwyn: You survived?
Dr Hart: Yes, and we are here still.
Q755 Viscount Simon: How often is
NHS Direct contacted about allergy related conditions and what
are the most common queries sought?
Ms Young: The difficulty for NHS Direct in answering
that specifically is that the service is symptomatic based. In
other words, when a caller or a person activating the website
makes contact with us, they are presenting us with their most
common or urgent symptom. What I have tried to do in answering
this question is to attack it from both directions. We estimate
that we receive over 600,000 calls per month to the service and
probably in excess of a million hits to the website per month.
Of those calls, for instance, allergies might present as either
severe breathing difficulties or difficulties with an airway.
Those two particular groups will probably lead to an urgent 999
call if the caller was in difficulty. The other allergy related
inquiries that will present as are wheezes, rashes, nasal congestion
et cetera, again dependent on seasonal differences. All of those
calls are likely to be or could be allergy related. We have four
specific algorithms that are launched directly as a result of
a caller saying they are calling in relation to an allergy query,
two for adults, one for a toddler and one for a child. We have
hard data on how many times we launch those algorithms. Interestingly,
those numbers are significantly lower than I expected to report
to you. For instance, those four algorithms that I have mentioned—two
adult, one toddler and one child—are only launched approximately
2,000 times in a year. That is not helpful to you because clearly
that is masking the fact that the calls that are about wheezing,
breathing difficulties, nasal congestion are likely to be allergy
related. We have anecdotally looked at what nurses are doing and
what types of calls they are taking. Anecdotally, I am going to
report that about 50 per cent of the calls that we take that either
turn out to be allergy related because the caller says they are,
or turn out to be allergy related because we assess them as so
are related to allergies in direct response to taking medication.
The other 50 per cent can be broken down into allergy reactions
and are likely to be due to food, non-food such as substances
used in the environment or seasonal differences such as hay fever
and pollen. All of these combine with problems with nasal congestion,
eyes, rashes, et cetera. Above and beyond that, I can give you
a breakdown of the allergy related algorithms that we launch.
We see 75 per cent of the calls that we take pertaining to adults
over the age of 17 years. 14 per cent of the calls that we are
taking in relation to allergies are bracketed within the 5 to
16 year old related callers and about 12 per cent pertain to those
calling where the child would be under the age of four. That is
as comprehensive an answer as I can give you based on the type
of service that we are.
Q756 Viscount Simon: I understand
the 999 response you have given but how do your staff recognise
a condition such as anaphylaxis and drug hypersensitivity reactions
and how is the adequacy of their advice audited?
Ms Young: We absolutely recognise life threatening
symptoms and those are the ones that can go to 999. Whatever the
call of the life threatening symptom, it may well go to 999. Anaphylaxis
is an issue that we would obviously be able to assess. In some
cases we will give what I will loosely call first aid advice there
and then to alleviate the condition in waiting for the ambulance
to arrive or in waiting to get to an urgent GP or vice versa.
In relation to how we assess our performance, our success and
our clinical effectiveness, all our calls to NHS Direct are recorded
and subject to peer review. A selection of the calls our nurses
take will be peer reviewed by a supervisor and usually another
clinician. We do pick up where the practice either needs to be
improved or where we have it wrong or where a nurse had indicated
that we have gone down one algorithm. We just check that it could
not have been something else.
Q757 Chairman: On the NHS Direct
website, am I right that there is advice on peanut avoidance for
pregnant mothers and infants from families with a history of allergies?
Ms Young: Yes.
Q758 Chairman: I wonder why that
is still there and what evidence there is, given that that is
now disputed advice?
Ms Young: I do not specifically have evidence
in front of me today to refute that or reply to that but I am
willing to submit some evidence. I will review it and I will review
the evidence behind it and submit that subsequently to the Committee.
Q759 Lord Colwyn: Mr Dillon, I wonder
if you could update us on the submitted proposals from the Department
of Health to NICE on the development of allergy guidelines? Have
you any news on those and when they might be published?
Mr Dillon: NICE is already producing a clinical
guideline on asthma in children. We have been consulting on that
and we will publish a draft of that in the summer of this year
and we will publish the guideline, subject to our consultation,
in December. We have also published a number of recommendations
on the use of inhalers for treating asthma and drugs for treating
eczema. The Department of Health had asked us to consider the
slight oddity in the way in which topics are considered and approved
for NICE. There is a process which involves consideration by NHS
clinicians and others of the potential topics right across the
range of services that the NHS provides. A short list goes to
ministers. Ministers consider which of those they wish to refer
to the Institute. The DH itself though at a policy level can feed
into the start of that topic selection process and they have done
that for the allergy related topics. Those topics have migrated
their way through the system and are now back with the Department
of Health and ministers for consideration. They have not yet been
referred to the Institute and I do not as of today have any indication
of when they might be referred to NICE. Assuming they are referred
some time during 2007, we would then slot them into the first
available guideline development opportunity and if we can start
them all in 2007 they would all be published at some point before
the end of 2009.
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