Consultation
Response to Human Genetics Commission Consultation
on Marketing Genetic
Tests
Submission by
Dr. David King - Human
Genetics Alert
9th October
2002
Summary
HGA's primary concern about the direct
marketing of genetic tests is the harm that may be caused to both
individuals and society if market forces are allowed to control the
availability of genetic tests.
In the USA, where genetic tests are currently not regulated
we have already seen:
-
Testing without requirements for
counselling or consent
-
The marketing of tests whose predictive
value and medical utility is
uncertain.
-
Manipulative
advertising
-
Testing that abuses children's
rights
-
Widespread availability of unethical tests,
such as prenatal sex
selection
Genetic testing has many consequences for
both individusl and society and its regulation must not be treated
simply as a narrow consumer protection issue in isolation from the
broader concerns raised by genetics. In addition to the
well-known individual harms that may arise from unregulated genetic
testing there are a range of social harms that may also occur,
including the encouragement of a free-market eugenics, harm to
public health and the market ingof genetic tests for cosmetic and
'enhancement' purposes.
We would argue that there are intrinsic features of
genetic information which make it especially sensitive both for
individuals and society.
We reject the idea that there is any absolute
right to discover genetic information about oneself. Because of the many
consequences of genetic testing for both individuals and society,
individuals' wishes to discover information must be balanced against
other values and interests, including that of society at
large.
We believe that it is highly premature to
conclude that there are any genetic tests that do not require
counselling. Genetic
testing should take place in the context of medical practice and
should always be accompanied by
counselling.
HGA therefore calls for a ban on
over-the-counter genetic testing, backed by legislation. Genetic
testing in the NHS and private medical practice should be regulated
by an authority with legal powers. Any less strict options are, in
our view, inadequate.
Such regulation must consider the social and ethical impact
of each test, not just aspects such as clinical validity and
utility.
1.
Introduction
Human Genetics Alert (HGA) is an independent
watchdog on human genetic issues. Our aim is to prevent harm to
individuals and society arising from inappropriate genetic research
and its application. We seek to encourage informed critical public
debate.
2. Why regulate
genetic testing?
HGA's primary concern about the direct marketing
of genetic tests is the harm that may be caused to both individuals
and society if market forces are allowed to control the availability
of genetic tests. We would emphasise that this is
not merely speculation. In the USA, where genetic tests
are currently not regulated we have already seen:
-
Testing without requirements for counselling
or consent[i],[ii].
-
The marketing of tests whose predictive value
and medical utility is uncertain[iii],[iv].
-
Manipulative advertising[v]
-
Testing that abuses children's rights[vi]
-
Widespread availability of unethical tests,
such as prenatal sex selection[vii]
HGA therefore believes that it is imperative to
regulate genetic testing, which should always be done in the context
of medical practice. It is crucial that regulation
encompasses genetic testing as a practice, not merely genetic tests.
Genetic tests may be offered in different contexts. The consequences
that flow from them, both for individuals and for society, will
depend on the context. A test that has relatively few consequences
in one context may be full of serious consequences in another
context. An obvious example is prenatal and pre-implantation genetic
testing, which is why the direct marketing of tests in the context
former is prohibited by the existing code, and in the latter case is
regulated by the HFEA.
It is a mistake to deal with genetic testing and
regulation in isolation from the broad scientific and social
processes of which it is part, and from the consequences of those
processes. Although research and the application of genetics has
much potential for good it may also lead to significant harms to
individuals and society. Thus there is need for a general process of
democratic supervision of genetic research and its applications are
rolled out. Therefore, the regulation of genetic testing must not be
treated as a narrow matter of consumer protection, and in isolation
from the broader concerns raised by genetics.
In considering the scenario of marketing genetic
tests by commercial companies, it is possible to identify the
following harms:
Individual harms
1. Individuals may spend considerable sums of
money on inappropriate and/or irrelevant tests, due to misleading
marketing. Given the low level of public understanding of genetics
and the prevailing climate of hype surrounding the subject, this
seems very likely.
2. In the absence of counselling from trained
genetic counsellors, individuals may be misled about their genetic
constitution. This may lead to their taking sometimes-irreversible
bad decisions which may have profound effects on their lives and
those of their families. This may include reproductive decisions
(see 'social harms' section).
3. Even when trained consulting is available,
individuals may suffer psychological harm.
4. A potential consequence of taking genetic
tests is discrimination by insurers, employers and
others.
5. Genetic testing opens up the possibility of
a variety of family problems. People may be stigmatised within their
families and feel guilt for "creating" a problem for the whole
family where none was perceived before. These and other
possibilities may exacerbate existing rifts within families.
6. Genetic test results may also raise the
explosive issue of non-paternity.
Survey evidence[viii],[ix] indicates that
people are, when the possibility is presented in a theoretical way,
very interested in genetic testing. However, the actual uptake of
genetic testing is currently low, which suggests that when people
start to look into the question in detail and inform themselves
about the possible risks, they become much less enthusiastic. This
reinforces the need for pre-test genetic counselling.
It is useful to compare drug prescription with
genetic testing. Many drugs are only available on
prescription for two main reasons: medical expertise is needed to
advise on choice and dosage of drug; and the drugs are capable of
harming the patient. Clearly, there is just as great
need for trained medical advice in choosing and interpreting genetic
test results as in choosing drugs. Although drugs can cause physical
harm to patients, this is generally minor and short term: the
patient feels ill, stops taking the drug and reports the problem to
the doctor. With genetic test results, the
consequences, whilst not physical may be more severe, since the
misinterpretation and the consequent decisions may have effects that
last the lifetime of the patient and her family, and even reach down
the generations.
Social
Harms
1. Free-Market
Eugenics
The most important social harm likely to result
from non-regulation of genetic testing is the facilitation and
encouragement of a free-market eugenics, driven by aggressive
marketing and a variety of social trends. This free-market eugenics
is seen by many commentators as the major concern raised by the
genetics revolution. There is a tendency to assume that the genetic
testing of adults outside of the direct reproductive context does
not have implications for reproductive choices. This is the reason
that the existing code permits carrier testing of adults for
autosomal recessive conditions. However the assumption is clearly
false - in fact, adult testing may be a major driver of eugenic
social trends in a number of different ways.
Firstly, one way in which adult genetic testing
is almost certain to connect with eugenic forces is in sperm and egg
donation. A free-market eugenics already exists in this field, with
sperm banks and internet sites offering gametes from 'superior'
individuals at high prices[x]. It is very likely that,
in the near future, competition will drive such gamete providers to
demand genetic tests from donors in order to provide clients with
gametes with a 'clean bill of genetic health'.
More importantly, as demonstrated most
obviously and clearly by cystic fibrosis carrier testing, such tests
with no medical consequences for the individual are taken precisely
for the purposes of reproductive decision-making. In the future, if
genetic susceptibility tests for a variety of rare and common
conditions are marketed, it is likely that these will be taken into
account in reproductive decisions. In fact, it is extremely
implausible that they will be seen as purely relevant to the
individual's own future health and not to their reproduction. This
is the nature of genetics, and is one feature that distinguishes
genetic tests from, for example, PSA tests. It is
possible, and is indeed often confidently predicted by scientists,
that we will see the development of chips designed to test multiple
diseases, giving consumers an overall 'genetic health
check'.
Thus, it is quite possible that a climate will
develop in which it is seen as irresponsible for people of
reproductive age not to have genetic tests. Indeed, existing
experience with programmes of adult testing for single-gene disorder
carrier status suggests that social policies can be highly coercive.
In both the thalassemia testing programme in Cyprus and the Tay
Sachs program in ultra-orthodox Jewish communities, testing is
essentially mandatory. Although it seems unlikely that such strong
coercion would become the norm, aggressive test marketing could
produce significant eugenic pressure. It should be remembered that
when tests are taken in the reproductive context there is a
significant restraining factor: the idea of reproductive autonomy
and the woman's right to choose. When tests are taken outside of
the reproductive context, in early adulthood, this factor is not
present and ideas about a person's 'duty to the welfare of their
child' and to the community as a whole have correspondingly greater
effect.
We may see campaigns for adult carrier testing
to 'eliminate genetic disorders from the genepool' even for less
serious or adult-onset disorders. With complex diseases,
elimination is impossible, yet if important suscepitibility genes
are identified, similar pressures are likely to operate, in the name
of social and family responsibility.
Such adult tests could also affect people's
marriageability. For example, a man carrying a genetic variant
likely to lead to heart disease in his 40s might find it
increasingly difficult to find a partner.
2. Harm to public health
Promotion of over the counter testing may
damage public health and the NHS in a number of ways. Firstly it may
create a large number of 'worried well' people, who may
unnecessarily increase demands upon limited NHS resources. These
people may become vulnerable to aggressive marketing of
'preventative medicine', which may create dependency on drugs, and
prove impossibly expensive for the NHS[xi]. Such
drugs may themselves have serious side-effects. The use of
advertising to increase drug markets is not merely speculation but
an established strategy employed by the pharmaceutical industry[xii],[xiii],[xiv].
A further problem with the direct marketing of
susceptibility tests is that those 'given the all clear' by genetic
testing may feel they can ignore general healthy living advice,
creating greater health problems later.
3. Cosmetic/'enhancement'
tests
The marketing of genetic tests to predict
non-pathological and/or cosmetic characteristics may have social and
personal consequences which are just as severe as those created by
tests for serious disease. One way in which this might happen is the
genetic testing of children for example to determine their likely
future height, or for girls, breast size. This may lead to surgical
or hormonal interventions, such as the use of growth hormone, the
over promotion of which to short children is already a problem. It
is also possible that genetic tests will be used to target
preventative behavioural and pharmaceutical interventions, for
example to prevent anti-social behaviour[xv]. Such
approaches risk stigmatising large numbers of boys and precipitating
the very problems they intend to solve. While such interventions on
children are obviously unethical, in the absence of regulation, this
may not stop competitive parents.
For adults, the marketing of genetic tests for
example to promote longevity and how a person may age (baldness,
cellulite, wrinkles) is also likely to be encouraged by the
cosmetics and cosmetic surgery industry as a means of increasing
their markets. This is not merely distasteful but highly damaging to
individuals who may undergo unnecessary surgery and suffer
psychological harm. In HGA's view such cosmetic uses
of genetic testing would be extremely harmful to society and should
not be permitted.
A recent example of the potentially socially
damaging effects of the marketing of non-medical genetic tests is
the launch, by a US company of an unvalidated 'recreational' test
which claims to measure the degree of racial mixture in a person's
ancestry[xvi]. The
company says the results may also be used to 'validate your
eligibility for race based college admissions or government
entitlements.' Apart from the damage that may be
done to families by unexpected but unverifiable revelations, the
marketing perpetuates ideas of race based on genetics.
What is clear is the falsity of the assumption
in the consultation paper, that it is only genetic tests for serious
diseases that are a potential problem, requiring counselling and
regulation. This assumption would tend to leave many socially
damaging tests entirely unregulated. In fact, there is in general
greater public concern about the use of genetic technologies for
cosmetic and 'enhancement' purposes than for medical purposes. This
is part of the reason that the Council of Europe Convention on Human
Rights and Biomedicine stipulates that genetic testing shall only be
performed for medical purposes.
4. Encouragement of genetic
determinism
The proliferation of genetic tests is
likely to encourage the public perception that genes determine our
health, behaviour and prospects in life. There
is a need to counter such simplistic views of genetics through
public education. However, there is a limit to what
can be achieved by education if many different genetic tests of
dubious value are being marketed.
In summary, these social harms must be treated
very seriously. Failing to regulate genetic
testing is likely to lead to rampant commercialism, intended to
create new and unreal 'needs'. In the
USA, the outcome of non-regulation is already apparent in the
widespread availability of prenatal sex selection and other
abuses.
The consequences of genetic testing go far beyond the
immediate consequences of the test itself for that individual. The
regulation of genetic testing is a crucial element in the overall
social management of the introduction of genetic medicine, and to
abandon its use would be to essentially abandon any attempt to
moderate the many harmful individual and social consequences that
would arise from commercially driven genetic testing. The
remit of the HGC is to take a broad and holistic overview of issues
raised by human genetics and to make connections between those
issues.
We hope that the HGC will not view the regulation of genetic
testing as a narrow issue of consumer protection.
In HGA's view there is no case for allowing the
direct marketing of genetic tests to consumers. We therefore
advocate a ban on this practice. Given the potential social and
individual harms that may be caused by genetic testing, there is a
need for regulation of genetic testing which is carried out within
the NHS or private medical practice.
Such regulation must
consider the social and ethical impact of each test, not just
aspects such as clinical validity and utility. The need for social
and ethical factors to be taken into account has been emphasised by
many commentators, including the US Secretary's Advisory Group on
Genetic Testing (ref 4) and a recent consensus statement from US
experts[xvii].
3. Answers to
specific questions
Q1. What role, if any, do you
envisage for professional bodies in the regulation of genetic
testing services supplied direct to the
public?
As noted above HGA opposes the direct marketing
of genetic tests to consumers. If genetic tests are approved by a
statutory regulator there will be a need for guidelines for the use
of each test, specifying in which populations and under which
circumstances such tests should be offered. The professional bodies
will no doubt be involved in drafting such guidelines.
Q2: What aspects of the existing controls on
advertising would you wish to draw to our attention in conducting
this review? In what way, if any, should adverts for direct genetic
testing services be treated differently?
HGA believes that, like prescription medicines,
genetic tests should not be advertised direct to consumers. There is
already evidence that the advertising of such drugs in the USA has
distorted the market and led to an increase in spending (refs
12-14). There is also evidence that companies marketing genetic
tests both market in an exploitative fashion and provide misleading
statements to consumers about the conditions being tested for. In
one instance (ref 4; the advert is attached to this submission) a
company advertised BRCA1 and BRCA2 testing in the programme for a
play dealing with a woman dying of ovarian cancer. This was no doubt
intended to exploit the emotional vulnerability of the audience. The
advertisement invited women to contact the company directly rather
than via physicians and contained incorrect and incomplete
information. The current direct-to-consumer advertising campaign
launched by Myriad Genetics has also been criticised for playing on
women's fears[xviii].
Research has also shown that advertising can be
misleading in more subtle ways. Brochures produced by companies
marketing cystic fibrosis tests differed from hospital or university
pamphlets in that they 'minimise positive descriptions of CF'[xix] or did not contain
adequate information[xx].
These examples from what is currently a small
market foreshadow what is likely to occur if advertising of genetic
tests is permitted. HGA favours the extension of the current ban on
pharmaceutical advertising to advertising of genetic
tests.
Q3: What other national controls or
international instruments should we be considering during this
review?
Q4: Do you have any comments or suggestions
about the possible control on genetic testing services accessed via
the internet?
The possibility that people will be able to
access inappropriate genetic testing services via the internet is a
major concern. Clearly, an international approach is needed to deal
with this problem. From the point of view of the UK, it seems clear
that the major threat comes from the companies/laboratories in
Europe and possibly the USA. It seems unlikely that people will
trust the scientific competence of companies outside those countries
and there will be very little possibility for redress if something
goes wrong (eg: misdiagnosis, breach of privacy). HGA has called for
new EU legislation to regulate genetic testing in order to prevent
inconsistency between different EU countries. The UK should promote
this idea at EU level. We accept that it might not be possible to
completely control access to genetic tests via the internet.
However, this must not be seen as an excuse for failing to regulate
in the UK and the EU.
Q5: Should any controls or regulations be
confined to tests carried out on the genetic material itself, or
should they encompass tests on other aspects of body chemistry that
might be directly determined by information stored in the genetic
material?
When considering tests that are not DNA tests
for 100% penetrance disorders there are two key and independent
dimensions (i) how directly does the DNA variation influence the
parameter measured and (ii) to what extent is the disease/disorder
being tested for under genetic control.
When the penetrance is 100%, tests on protein
sequences and enzyme activity are simply reflections of the DNA
sequence, and should be seen as genetic tests.
If the disease is complex, eg: heart disease;
DNA, protein sequences and enzyme activity designed to determine the
genetic variation are genetic tests.
For 100% penetrance disorders, it is unlikely
that tests which measure the level of body substances will give good
predictions of the variations at the DNA level, Rather, these tests
are most likely to act as preliminary steps which may alert the
person of the need to visit their doctor, who will then confirm the
test results and refer the person for a DNA test. Such preliminary
tests may be acceptable for sale over-the-counter, as long as they
do not give clear predictions and firm evidence of a particular
genetic test result. For example, if there were a body substance
test that could predict whether a person will develop Huntington's
Disease, this should not be sold over-the-counter, for the reasons
outlined in section 2. In the case of preliminary body substance
tests, the taking of such a test is part of a process leading to
genetic testing and, as such, should be regulated. In some cases,
the regulator may decide that no harm will come from the
over-the-counter sale of such tests.
Q6: What are your views on which genetic
testing services can be considered, now or in the future, to be
defined as "direct to the public"?
HGA believes that all genetic testing should be
subject to regulation, including that offered through the NHS and
private medical practice.
Q7: What are the likely developments in the
genetic knowledge and technology that might impact on the number and
type of genetic tests offered direct to the public?
This question is incomplete: the number and
type of genetic tests offered to the public will depend to a
considerable degree on market forces and social trends.
It is difficult to predict the likely success
of efforts to identify susceptibility genes for common diseases;
there are conflicting views in the scientific community and much
confusion on this point. At present, there are many conflicting
scientific findings, and failures to replicate gene-disease
associations. However, this is not surprising, for the following
simple reason: the studies measure associations between genes and
diseases such as diabetes which are, in fact, a composite of many
different sub-types of disease which share similar symptoms. The
promise of genomics, proteomics, and other molecular biological
research is to dissect the different sub-types and elucidate the
molecular pathways which lead to symptoms. Within each sub-type
there will probably be only a few different key proteins, genetic
variations which affect disease susceptibility, and it is very
possible that genetic testing that will be able to provide good
predictions of disease susceptibility.
Some companies are already marketing genetic
susceptibility tests and there is very substantial investment taking
place. Without regulation, tests of dubious scientific and medical
value will no doubt continue to be offered.
While there are scientific problems concerned
with the validity and utility of genetic test results, it is
unlikely that technological barriers to the offering of cheap tests,
involving multiple genes, will remain in place for long. A company
has recently announced, for example, the development of a prototype
'black box' for 30 minute testing in pharmacies[xxi].
Q8: What distinction, if any, should be made
between genetic tests and other medical or health-related tests
which might be offered direct to the public?
Q9: If testing for non-genetic conditions is
available direct to the public with few restrictions, then is there
a case for restricting the availability of testing for genetic
conditions?
Q10: What distinction, if any, should be made
between genetic tests intended for:
- predictive health purposes;
- diagnostic purposes;
- life-style or other purposes which have a
limited impact on someone's life?
HGA disputes the committee's reasoning in
paragraph 42 and its conclusion that there is nothing special about
genetic information that distinguishes it from other medical
information. This was not, in fact, the conclusion of the Inside
Information consultation. We would argue that there are intrinsic features of genetic information
which make it especially sensitive both for individuals and society.
Although some of these features are shared to a small degree by some
other examples of medical information, it is a fallacy to assume
therefore that genetic information has no special significance. It
is the combination of these features, like the combination of
qualities of any object or idea that distinguishes it from other
objects or ideas.
As we noted in our response to the Inside
Information consultation the features of genetic information which
distinguish it from other medical information are:
1. Notwithstanding the incorrectness
of popular overblown accounts of genetics, it is impossible to deny
that the molecular genetics revolution of the last 20 years has
given us access to a whole new level of biology. Although genes are
not the 'blueprint' of an individual, there is an important sense in
which genetic information is more intimate and fundamental
information about a person than what their parents died of, or their
cholesterol level. Genetic information defines something more
enduring and constitutive about a person than whether they have high
blood pressure or have contracted cancer. Whereas the latter may
fluctuate during a person's life, and are seen as semi-random events
that may or may not occur to a person, a person's genes are fixed at
conception and remain constant. To whatever extent genes determine
the person's characteristics, they are enduring and constitutive
facts about that person. Amongst the characteristics where the
influence of genes is strong are many of the external facets that a
person presents to the world, and through which we recognise them
throughout their life: sex, facial features, body shape, skin and
hair colouring. It is not simply ignorant genetic determinism that
leads people to view genetic facts about a person in a different
light to whether they have had the bad luck to have had a heart
attack.
Because of these features of genetic
information, it is likely to have a greater role in defining the
results of medical tests and is likely to have a greater role in
defining their self-identity than a cholesterol-level test. The
former is far more likely to make a person feel like there is
something intrinsically wrong with them, that they can do nothing
about, than the results of medical tests. Thus genetic test results
may have much more psychologically damaging consequences than other
medical test results.
2. Genetic information is hereditary
information, unlike almost any other medical information. Thus
information about a person's genes will often immediately raise very
sensitive issues about reproductive choices. Issues of equal
sensitivity arise about the person's own parentage. Genetic
information is also about families much more strongly than most
other medical information, and thereby raises issues which are not
raised by most other medical information.
3. Most importantly, the social meaning of
genetic information is very different to that of most medical
information. Primarily because genes define crucial and enduring
aspects of a person, and because they are passed on to offspring,
perceived and real genetic differences continue to attract
discrimination and oppression. A fully-fledged theory of social
development (eugenics) is based on the importance of genetic
differences. It is ridiculous to imagine anything comparable based
on cholesterol test results.
The greater
intrinsic personal and social
sensitivity of genetic information means that there is a strong case
for regulating access to genetic tests. As we
have discussed in section 2 this point applies to all tests, not
merely tests to detect serious disease.
Q11: If people are interested in finding out
personal information about themselves, then should they be entitled
to obtain such information in whatever way they wish?
In HGA's view the suggestion that there might
be some 'right' to personal genetic information is biased and
misleading. A 'right' is the strongest type of claim, one which
other considerations cannot outweigh. To establish a 'right'
therefore requires extremely strong, clear-cut argument and strong
social consensus. In our view, while there are some arguments in
favour of allowing people to find out genetic information about
themselves these are in no way sufficiently strong, nor do they
command anything like the social consensus necessary to attain the
status of a 'right'.
The notion that there exists a right to
discover genetic information about oneself appears to rely on an
elevation of one ethical value - autonomy - above all
others. However, there are other ethical values which
healthcare providers and the state must take into account: doing
good, doing no harm, justice and the interest of others. In
considering whether an action is ethical we must consider the
consequences that are likely to flow from it. As we have discussed
in section 2, genetic testing has the possibility to (a) do no good
(b) do harm (c) result in injustice, and (d) harm the interests of
others and of society at large. In our view it would be
irresponsible and unethical in the extreme to ignore these
possibilities by elevating the value of autonomy to the status of a
right. Rather, these competing values must be negotiated on a
case-by-case basis, depending on the genetic test concerned, who is
to be tested and in what context. If we do decide that there is a
'right' to have access to all genetic tests, we are deciding to
abandon the possibility of regulation, and leaving the development
of genetic testing to market forces. The consequences of such a
position are, as has been noted, already extremely negative:
marketing of unethical tests (eg: pre-natal sex selection), without
counselling, through exploitative and misleading advertising, and
the abuse of children's rights.
The idea that there might be a 'right' to find
out personal genetic information seems to stem from a confusion
created by the use of the word 'access'. It is agreed that where
medical or genetic tests have been taken, the person has a right of
access to their medical records to discover this information. This
is very different from some putative 'right' to discover personal
genetic information where that information does not already exist.
The act of discovering such information has multiple personal and
social consequences, as outlined in section 2, which make the
discovery of personal genetic information a matter of social
policy.
Q12: Should direct genetic testing services be
limited to adults capable of making informed consent?
Genetic testing should not be marketed directly
to either adults or children. The regulation of genetic testing, in
the context of the NHS or private medical practice, must include
measures to prevent the testing being offered to children where it
may cause them harm and offer them little medical benefit. As the
Clinical Genetics Society guidelines stipulate, genetic tests should
only be given to children where they have some clinical utility, ie:
where some treatment or preventive measures are available. We are
particularly concerned that by reports that some private adoption
agencies in the US are requiring children to be tested because of
demands from adoptive parents (ref 4). In our view, this form of
market-driven genetic discrimination is a completely unacceptable
abuse of children's rights and cannot be permitted.
Q15: Do you consider that there should be some
independent process to review the accuracy and reliability of some
or all types of genetic tests that are available direct to the
public? If so, how might this be achieved?
It is, of course, necessary that tests of any
type satisfy the necessary standards of accuracy and reliability, as
should the laboratories performing them. It is standard practice for
this to be achieved by independent external scrutiny.
We are extremely surprised, especially in the
light of its recent experience with Sciona Ltd, where this was the
main issue, that nowhere in the consultation document is there any
mention of the need to regulate tests according to their clinical
validity
(ie: whether the test has any power to predict or diagnose
clinically important outcomes) or clinical utility (whether the test
results leads to any clinically useful intervention). These
elements, plus the social and ethical impact of the test, were
agreed to be vital elements in the assessment of any genetic test by
the recent US experts' consensus statement (ref 17).
Q16: Should the value of any pharmaceutical or
life-style intervention that is linked to a genetic test be
considered as part of any accreditation process? How would this
relate to established mechanisms for professional
self-regulation?
As part of the assessment of the public health
impact of genetic testing, it is of course vital to consider the
possible impact on individuals and the NHS of intervention following
on from genetic testing.
Q17 For which type
of tests should access to appropriate pre and post test counselling
be a requirement? Who should undertake this?
Counselling should be offered both before and
after all types of tests, which should take place in a clinical
context. As we have demonstrated in section 2, it is far more than
tests for serious diseases which may affect the patient in their
lifetime that call for counselling. In fact, this assumption is
counter-productive if it permits testing for cosmetic or other
non-pathological characteristics.
It has yet to be demonstrated that there are
any genetic tests which are sufficiently low-impact to responsibly
dispense with counselling (with the exception of blood-group
testing). In the Inside Information report the HDC's
main candidates for reduced levels of counselling were carrier tests
and pharmacogenetic tests. The former are
clearly taken for reproductive purposes and may have large social
and individual consequences. We believe the current code is
incorrect in allowing their over-the-counter sale. As for
pharmacogenetic tests, the HGC has noted that it has not yet
adequately explored their ethical and social implications. Such
tests may have strong individual consequences if the tests also
predict disease susceptibility[xxii],[xxiii] or prognosis.
HGA believes that it is highly premature to
conclude that any genetic tests do not require counselling. We
disagree that genetic tests will have fewer implications for the
client than other tests or medical procedures for which counselling
is not the norm. If this is the case then, clearly, greater levels
of information should be given to patients in those cases in order
to achieve informed consent. The government has acknowledged that
the NHS practice in informed consent does not meet necessary
standards. Standards must be raised for all procedures, not lowered
for genetics.
The
provision of counselling
We agree with the committee's concern that if a
large market for over-the-counter testing develops this may strain
NHS resources. We are extremely concerned by the overall tendency
evident in some bioethics literature, to argue that counselling is
unnecessary. In our view, this argument may be driven by the
relative lack of trained counsellors and pressure to introduce
tests. In HGA's view, ethics should not be driven by economic
pressures, nor scientific and medical enthusiasm. Since adequate
counselling is a vital need, tests should not be introduced until
there are adequate counselling resources to meet demand. If
over-the-counter sale of genetic tests is permitted it is vital that
face-to-face counselling is available. Such counselling must be
independent of the company marketing tests, in order that there is
no suspicion of conflict of interests leading to biased counselling,
as it already leads to biased information in information leaflets.
The obvious source of such counsellors is the NHS, but the NHS must
be compensated for the full cost of providing such counselling by
the companies concerned. The companies in turn will no doubt pass on
such costs to the consumer, leading to a realistic price for
testing. Companies should not be permitted to offer 'no-counselling'
options.
Q18 What are your
views on the need for more general consumer information or education
about the issues raised by direct to the public genetic
testing
It is vital that there is more public education
about human genetics issues in general. Such education programmes
should not, as has often been the case in the past, be designed to
facilitate acceptance of new products and services but offer
customers unbiased information and a fair sampling of arguments from
different quarters, especially including disabled people. Public
education programmes must explicitly aim to combat geneticisation,
genetic determinism and eugenics.
Questions
19-25
HGA calls for a
ban on over-the-counter genetic testing, backed by legislation.
Genetic testing in the NHS and private medical practice should be
regulated by an authority with legal powers. Any less strict options
are, in our view, inadequate.
References
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21
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[xvi] Wade, N. 2002 New York Times October 1st.
[xvii] Burke, W. et al 2002 American Journal of
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[xviii] Moreno, J. 2002 'Selling Genetic
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[xix] Loeben, G.L. et al 1998 American Journal of
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[xx] Cho, M.K. et al 1999 Appendix 4 in Promoting
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[xxi] Briggs H. 2002 BBC News Online
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