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Submission from CMF to the Human Genetics Commission on 'The Supply of Genetic Tests Direct to the Public'

Published: 4th October 2002

Introduction

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.

Preamble

Our submission is based on the following presuppositional framework:

  1. Human beings have been individually created by God and, despite their fallenness and imperfections, derive their integrity and worth from the fact that they are made in the image of God - regardless of genotype or phenotype. We are 'flawed masterpieces' - and a complex unity of body, mind and spirit. The diversity of individual human beings is a composite of genetic, environmental, social, volitional and spiritual factors and is part of the wonder and strength of God's sovereign design. The presence of a disability, either inherited or acquired, does not detract from a person's intrinsic worth.
  2. God requires us to be good stewards of creation, both of the surrounding world, and ourselves, but human knowledge and wisdom are limited and may be used for evil or good. It follows that the scientific exploration of life, including its genetic foundation, is proper and consistent with God's mandate and humanity's created nature, but must be conducted within biblical constraints. The end never justifies the means. We should use genetic information to guide the care and management of patients, and in developing new treatments, but always with the intention of loving and serving others, especially the most vulnerable.
  3. Genetic testing and therapy should be entirely voluntary and require informed consent. But in the case of the subject being 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. An individual's genetic information should be kept confidential except; a) where it is necessary for it be known in order to benefit the life and health of that affected individual, or b) on the rare occasions where it is legitimately necessary to benefit the life and health of a relative and not just the affected individual themselves.
  4. We therefore have grave concerns about the search for, and use of, genetic information for the purpose of discriminating against an existing human life, born or unborn. Such action discriminates on the basis of genotype - and is therefore incompatible with the Judaeo-Christian ethic and the spirit of historically accepted ethical codes including the Hippocratic Oath, Declaration of Geneva (1948), the International Code of Medical Ethics (1949) and the Declaration of Helsinki (1975). Doctors are required to maintain the deepest respect for individual human life from its beginning to its end. This involves protecting individual human beings, especially vulnerable human beings, from any form of exploitation including commercial exploitation. While we can judge the effectiveness of treatments, we are in no position to judge any human life as having less value than others or as unworthy of life.
  5. The role of medicine is to diagnose disease with a view to treating it and relieving its symptoms. We acknowledge that there are 'shades of grey', particularly in deciding when a condition moves from being part of the rich tapestry of life to being abnormal and requiring treatment, be it pharmacological, psychotherapeutic or genetic. However we also believe that we must beware of any tendency and resist any pressure to medicalise characteristics that fall in the 'normal range'.
  6. Human behaviour and disease is influenced by both genetic and environmental factors, but whilst single gene disorders exist, the relationship between genes and behaviour or genes and disease is usually complex. In most cases, and especially with mental disorders or multifactoral syndromes, the genetic factors predispose towards the eventual phenotype rather than predict it. Our experience is that the general public makes the mistake of assuming that if you've got the gene you get the condition. As scientific doctors and as Christians, we are opposed to this crude determinism. We have a responsibility to ensure that knowledge about the genetic basis of human disease and behaviour is reliably and accurately reported to the public, and that vulnerable members of the public are not misled about the significance of specific positive genetic tests.

General comments

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

  1. the family of the individual being tested
  2. the wider community as a whole

Answers to the specific questions raised in the consultation document

1. What role, if any, do you envisage for professional bodies in the regulation of genetic testing services supplied direct to the public?

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.

2. What aspects of 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?

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.

3. What other national controls or international instruments should we be considering during this review?

We agree that international co-operation is essential but have no further suggestions as to how this can be accomplished.

4. Do you have any comments or suggestions about the possible control on genetic testing services accessed via the Internet?

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?

5. 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?

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

6. 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'?

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.

7. 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?

The development of microarrays presents the possibility of testing for large numbers of genetic variants using only a small amount of DNA.

8 & 9. What distinctions can be made between genetic tests and others? Why restrict genetic tests and not others that are available direct to the public?

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.

10. What distinctions can be made between genetic tests with different intentions (diagnostic, predictive, life-style)?

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.

11. If people are interested in finding out personal genetic information about themselves, then should they be entitled to obtain such information in whatever way they wish?

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.

12. Should direct genetic testing services be limited to adults capable of making informed consent?

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.

13. With appropriate consent, should results from direct genetic testing be recorded in the GP record? Should this be encouraged within any future regulatory system, and if so, how might this be done?

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).

14. What are your views on the arrangements for retaining and using samples and data?

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?

[15. Accuracy and reliability of tests - see question 1]

16. 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?

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.

17. For which types of test should access to appropriate pre- and post- test counselling be a requirement? Who should undertake this?

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.

18. 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?

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.

19. Do you believe that the option of no specific regulation is desirable?

No, some regulation is essential

20. If you believe that there should be some form of regulation, then is a voluntary code of practice the best way to achieve this? If not, how else could this be done?

21. If a new voluntary Code of Practice were to be introduced, what issues do you think it should cover?

22. What are your views on who should be responsible for introducing and administering any new Code of Practice?

23. Should any new voluntary code of practice stipulate that certain tests should not be offered direct to the public? If so, which type of tests should not be offered?

24. If certain tests were not to be offered direct to the public, what process or criteria should be used to identify such tests?

25. Do you think that a strict regulation system, of the sort described in Option 4 above would be desirable?

[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.]

For further information:

Steven Fouch (CMF Head of Communications) 020 7234 9668

Media Enquiries:

Alistair Thompson on 07970 162 225

About CMF:

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.

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