Printed from: https://www.cmf.org.uk/advocacy/submissions/?id=22
Published: 4th October 2002
Christian Medical Fellowship (CMF) is interdenominational and has as members over 5,000 doctors throughout the United Kingdom and Ireland who are Christians and who desire their professional and personal lives to be governed by the Christian faith as revealed in the Bible. We have members in all branches of the profession, and through the International Christian Medical and Dental Association are linked with like-minded colleagues in more than 90 other countries.
We regularly make submissions on a whole range of ethical matters to Governmental and other bodies, and welcome this opportunity to comment on 'The supply of genetic tests direct to the public'. This Submission has been produced after discussion with members of our Medical Study Group.
We have made other submissions to official bodies on genetics issues which are accessible on our website at www.cmf.org.uk and the committee is welcome to consult these:
In addition to these we have published articles on Genes and Behaviour and The Human Genome Project, which provide an ethical framework for our approach to genetic issues.
Our submission is based on the following presuppositional framework:
CMF is glad that this important matter is being given the careful consideration due to it and supports the Working Group in its deliberations. We are particularly encouraged by the Working Group's emphasis on the need to protect vulnerable members of the community.
We acknowledge the two factors outlined in paragraph 3 leading to the need for changed attitudes from professionals towards the public's access to medical tests and their results, and note also that in out current society both market forces and the autonomy of the individual tend to dominate the debate.
We wish to emphasise our concern for the well being of
Maintenance of accuracy of test results is of paramount importance. Even with tests simply leading to lifestyle changes, a false test result could have serious consequences on an individual's health, and even on that of other family members.
Laboratories offering tests should be licensed and subject to similar quality control to that of NHS diagnostic labs. This raises the question of who should be responsible for such licensing. One option is inclusion in NEQAS schemes, but this may be difficult as the testing itself is not part of any NHS NEQAS scheme. The current accreditation that ICI Cellmark use for paternity testing may be a useful model, since they are known to be particularly stringent.
Others, such as counsellors should also be regulated by the appropriate body, as is now the case with counselling in general. Counselling should be promoted in conjunction with tests so that the testing is seen as an important and serious matter, rather than just 'having a go' because it is available. Thought should be given to the training that will be provided for such counsellors, and how they are to be regulated (see also question 6).
The responsibility of those providing tests must be emphasised. This is particularly salient if provision is based on commercial interests; profit must not be allowed to overrule the best interests of the patient - 'businesses' involved in providing tests should be accountable to others for their activities in this area.
Similarly those seeking testing need to be invested with a sense of personal responsibility. This may be something that is lacking in our society. For this reason, there needs to be much greater education of the general public about the limitations and inaccuracies of genetic testing and prediction, and the unpredictable consequences of undergoing testing, before such tests become widely available.
From the outlines given it sounds as if there are already adequate controls in place. Much depends on how strictly they are monitored.
The British Code of Advertising and Sales Promotions' general principles indicates that advertisements must be legal, decent, honest and truthful and that adverts should be prepared with a sense of responsibility to consumers and to society. This cannot be emphasised enough with respect to genetic testing. Quite how to instil this sense of responsibility to those providing tests for commercial reasons is a different matter. Perhaps adverts should be limited to medical environments (hospital, GP's waiting rooms…) so that there is an immediate link with medical professionals. Similarly, advertising could be limited to leaflets that provide more extensive information about the test and its possible consequences, with advice about seeking professional help, rather than any kind of billboard, radio or television advertising.
We agree that international co-operation is essential but have no further suggestions as to how this can be accomplished.
Access via the Internet raises all sorts of practical difficulties and the real risk that individuals may be exploited for commercial gain. It also makes it very difficult to ensure the reliability and accuracy of tests. Can the mechanism outlined for HIV testing be modified and used?
Limit regulation to tests on DNA, certainly for the time being. Broadening the scope might make the regulations too cumbersome and complex to be enforceable
The suggestions of paragraph 33 sound sensible but could have very grey edges. When does a pharmacist or counsellor offering 'a service' to the paying public, and perhaps funded by the test-kit producing company, move into 'direct to public' mode?
Maybe there should always be an intermediary - pharmacist, counsellor or other responsible person - who would both 'sell' the product over the counter and be responsible for disseminating information/explaining test implications, much as a pharmacist may currently do with requests for cough medicine etc. This gatekeeper could be paid by the producer but would be responsible to some professional or similar body.
The development of microarrays presents the possibility of testing for large numbers of genetic variants using only a small amount of DNA.
Molecular tests (ie. those on DNA) should be distinguished from other medical tests because:
(i) positive results of general medical tests usually have immediate importance with action needed in the near future (eg. pregnancy, PSA, osteoporosis) whereas a positive genetic test may not require such action.
(ii) positive results of general medical tests are usually relatively straightforward to interpret. But the relationship between genes and disease is very complex (except for a small number of single gene disorders) and often poorly understood. Genetic tests therefore need specialised expertise to unravel. Some positive genetic tests (eg. various snps) could, on their own, be of little significance (as with Alzheimers and lipoprotein polymorphisms).
(iii) positive results of general medical tests do not usually have a health impact on other family members. This is not the case for genetic tests.
(iv) the interaction of genetic and environmental factors is complex and could more readily lead to misunderstandings than with general medical tests. Finding you have a positive pregnancy test result is quite different from finding you have a genetic variant known to be associated with delinquent behaviour in children from dysfunctional families.
Diagnostic tests should probably be treated separately. If an individual is symptomatic then medical input is almost certainly necessary, especially since such is currently necessary for more straightforward tests such as those for thyroid function. What is needed is a means of speeding up access to all diagnostic tests and investigations.
It is essential to balance the interests of the individual with the good of the community as a whole. The social and relational consequences for others of obtaining genetic information must always be considered. The right to privacy must be respected and we see no essential need for the GP to be informed. However, the points made in paragraph 45 are valid. It is important that the consequences for the health services of 'over the counter' testing are carefully considered. It is possible that there will be a substantially increased burden on existing health services from those who have obtained tests and from their relatives.
It has taken many years for the impact of commercial assisted reproduction facilities on publicly funded neonatal intensive care units to be officially recognised and a similar situation should be pre-empted by forward planning here. Possibly built into the cost of the test should be some contribution/insurance policy, which would provide for the ongoing needs of those who are tested and their relatives. Any such scheme would need very careful thought lest a two-tier system should develop.
Yes (see preamble, paragraph 3). Where a subject is unable to give consent, genetic testing or therapy should only be carried out for the specific purpose of benefiting that individual by enabling therapeutic intervention. Therefore children should not be tested at the request of their parents without the possibility of clear benefit to the child. The often-strong parental pressure should be firmly resisted. The only reason for testing a child is where that test will aid treatment and is in the current best interests of the child - an example would be a condition such as retinoblastoma where the test result is relevant during childhood.
Children are people in their own right and parentally driven testing precludes their making an informed decision for themselves when they are older. Additionally, a child's genetic information should be kept confidential unless it is necessary for it be known in order to benefit the life and health of that affected individual or, on rare occasions, where it is legitimately necessary to benefit the life and health of a near relative.
This consent should be obtained after the test result is available and while it is reasonable to encourage such notification for the GP record. Any pressure for this would be likely to be counter-productive because of the issues outlined in paragraphs 46 and 47 (disclosure of genetic information to employers or insurance companies, parentage).
If an individual is paying for the test and gives consent for their sample to be used, presumably for a fee, by some commercial company, then it would seem only just that the sample donor received some benefit from 'donating' their sample. If the company 'sells' the samples should the donor 'donate' theirs?
Yes, professional guidelines and review mechanisms as with other aspects of health care and provision. It is important both to maintain accuracy and updating to keep abreast of current best practice but also to counteract trivial use as in answer to question 1.
In the initial stages a broad range of conditions should be included on the understanding that after a trial time this might prove unnecessary. Initially counselling should be provided for all tests coming under the first 3 bullet points of paragraph 1. Counselling need not be extensive, but should aim to ensure that the applicant has an understanding of the implications and limitations of the test. Counsellors need basic training but need not be accredited genetic counsellors. This counselling should be face-to-face and not done via the Internet.
Greater education and information is required, particularly (i) to try and dispel the notion of there being a 'gene for…' characteristic x - especially in relation to complex conditions or behavioural traits; (ii) to explain that in view of the complex interaction of genes and environment the interpretation of some test results can be very 'woolly'; (iii) that the result of a genetic test, even a relatively trivial one, may be relevant to many other members of the family. If the result is of sufficient interest to an individual for them to request a test then other family members may have a similar interest. How this would be handled needs at least to be thought about and discussed.
No, some regulation is essential
[Questions 20-25 are difficult for us to answer, as we do not have adequate knowledge of the enforceability of voluntary Codes of Practice. Option 3 (voluntary regulation with restrictions on the type of tests that can be offered) is probably preferable with the exclusion of single gene, high penetrance, serious conditions (such as Huntingdons or genetically determined motor neurone disease) where more extensive support and follow-up would be required.]
Steven Fouch (CMF Head of Communications) 020 7234 9668
Alistair Thompson on 07970 162 225
Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 5,000 doctors, 900medical and nursing students and 300 nurses and midwives as members in all branches of medicine, nursing and midwifery. A registered charity, it is linked to over 100 similar bodies in other countries throughout the world.
CMF exists to unite Christian healthcare professionals to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.
