Supplementary memorandum by YORKTEST Laboratories
Ltd
NOMENCLATURE
Medical opinion recognises that food intolerance/sensitivity
exists. However, because there is no agreed nomenclature there
is confusion about what various parties are claiming or even discussing.
An agreed nomenclature used to clearly define food allergy, sensitivity,
intolerance etc would be beneficial.
UNMET MEDICAL
NEED
There is a huge unmet medical need for people
who suffer from food "sensitivity". The provision of
validated testing services would reduce NHS costs, and allow people
to make informed choices to enable them to lead more productive
and satisfying lives.
POLICING TESTING
SERVICES
All medical tests and testing services should
go through an agreed validation process before being offered to
the general public. Specified bodies should be responsible for
ensuring that all tests available to the public have gone through
an agreed scientific validation process. Organisations providing
testing services to the public should be regularly audited.
EXISTING REGULATORY
REQUIREMENTS
YORKTEST has fully met the regulatory requirements
in providing a self-test testing service by ensuring the whole
testing service is compliant with the IVD directive 98/79/EC annex
III section 6 (self-test). We know that this is not common practice,
but we have understood these regulations to be compulsory.
YORKTEST'S POSITION
YORKTEST, a small laboratory, has made every
effort to ensure that food-specific IgG testing carried out at
its laboratories complies with necessary regulations and good
clinical practice. YORKTEST has encouraged academic bodies to
undertake research into IgG testing and its role in identifying
food intolerances. A double-blind placebo-controlled study was
published in the international journal GUT, an audit of migraine
sufferers was published in Headache Care, and just recently (last
week) a major audit of over 5,000 people who had taken a YORKTEST
food intolerance test was published in the journal "Nutrition
and Food Science".
While we recognise that many people in the medical
profession are not yet convinced of the role of IgG as an indicator
of food intolerances, and we do not fully understand the mechanisms
involved, we have proven that three out of four people who follow
the advice given by the YORKTEST test report, get significant
relief from their symptoms.
LARGE NUMBER
OF UNQUALIFIED
TESTS AVAILABLE
A large number of tests are available to the
public that have no scientific basis or have never been validated.
For example, the use of electrodermal testing (Vega test) for
determining whether an individual is intolerant to a particular
food has absolutely no basis in science, yet it is widely available,
not only through complimentary or alternative healthcare practitioners,
but also in walk-in clinics and health food shops on the high
street.
CONFUSION
The public are frequently confused by the vast
range of tests available. The regulatory control over testing
services outside of the NHS is woefully inadequate, especially
if the test is not validated and is not accompanied with any interaction
with a health care professional.
THE LACK
OF REGULATION
The lack of regulation (or lack of policing
of the existing regulations) could actively be preventing people
from finding relief from their ill health symptoms.
CHOICE AND
TAKING RESPONSIBILITY
Giving patients more choice about how, when
and where they receive treatment is one cornerstone of the Government's
health strategy. Patients should be able to take more responsibility,
and have access to tests that can empower them, not potentially
damage them. The consumer needs to be suitably protected.
YORKTEST SUPPORTS
REGULATION
YORKTEST support the view that a system of regulation
is needed to assess the efficacy and to assure the quality of
such testing services, particularly if they are being accessed
directly by the public.
MHRA POLICING OF
TESTING SERVICES
DIRECT TO
THE GENERAL
PUBLIC
There is clearly considerable confusion about
the regulation of testing services, within the MHRA.
YORKTEST calls for:
(1) A Competent Authority to be set up to
regulate diagnostic testing services.
(2) That all testing services should go through
an agreed validation process before being offered to the general
public.
(3) Organisations providing testing services
to the public should be regularly audited.
Reference should also be made to the report
that is about to be issued by the Science Council's Science in
Health Group Integrated Diagnostics project.
CLINICAL TRIALS
(FOOD-SPECIFIC
IGG TESTING)
While YORKTEST as a small company has encouraged
academic bodies to undertake independent research into food-specific
IgG testing and its role in identifying food intolerances, there
is a clear need for a great deal more research to better understand
the mechanisms involved in non-IgE mediated food allergy.
The independent studies which have been carried
out include a double-blind placebo-controlled trial in IBS published
in GUT which, for clarity in response to other statements made
during this inquiry, showed that the number needed to treat for
compliant patients was 2.5.
Two more independent randomised controlled trials
(RCT) in IBS are scheduled for completion this year and funding
is being sought from the Clinical Trials Unit at the University
of York for an RCT in Migraine.
Studies into IgG testing in Inflammatory Bowel
Disease are being presented at Digestive Disease Week in
May 2007.
In February a major audit of over 5,000 people
who had taken a YORKTEST food intolerance test was published in
"Nutrition and Food Science". The feedback YORKTEST
has received demonstrates that many people in the medical profession
are not convinced of the role of IgG as an indicator of food intolerances.
YORKTEST does not claim to fully understand the mechanisms involved,
but the trials, surveys and anecdotal reports consistently show
that three out of four people, who follow the advice given by
the YORKTEST test report, get significant relief from their symptoms.
SCIENTIFIC ADVISORY
BOARD
In order to provide scientific support for their
services, YORKTEST established a Scientific Advisory Board of
independent scientists, leading medical consultants and dieticians
to advise the company on clinical trials, exploring the science
behind the various tests as well as reviewing and advising on
the supporting materials and advisory services offered by YORKTEST
to its customers.
UNMET MEDICAL
NEED
There is a huge unmet medical need for people
who suffer from food "sensitivity". The wider provision
of properly validated testing services would reduce NHS costs,
and allow people to make informed choices to enable them to lead
more productive and satisfying lives.
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