Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Authors misrepresent goals and pitfalls of NIPD
- Zuzana Deans, Ainsley J Newson (10 July 2009)
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Schmitz et al overplay the ethical pitfalls of NIPD
- Jane Fisher (16 July 2009)
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Authors' reply to Deans and Newson
- Dagmar Schmitz, Wolfram Henn and Christian Netzer (17 July 2009)
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Let’s make things better: prenatal test requirements raised to the Senseo®-standard?
- Antina de Jong (1 October 2009)
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Zuzana Deans, Research Associate Centre for Ethics in Medicine, Department of Community Based Medicine, University of Bristol BS6 6AU, Ainsley J Newson
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Schmitz et al. sensibly argue that non-invasive prenatal diagnosis (NIPD) should be accompanied by two-step counselling. However, they misrepresent the goals of NIPD and mostly appeal to problems concerning prenatal testing in general. The “typical goal” of prenatal diagnosis is not termination of pregnancy, but to offer information to facilitate informed decision-making. This could lead to a termination, but may also provide opportunities to plan for a child with a disability or for management of pregnancy or delivery. NIPD could also offer women the chance to find out important information about conditions they would not terminate for without risking their pregnancy. Balancing a pregnant woman’s autonomy with the (possible) rights of the fetus is a long-standing issue, but is not new to NIPD. It is an accepted part of prenatal testing that the informed wishes of a couple and the bodily integrity of the pregnant woman necessarily override the interests of the fetus. For those who take a gradualist approach to fetal rights, NIPD could actually be of comfort, since testing can take place earlier in pregnancy. Longer waits for results and possible conflicts with legal time limits for termination may also be avoided. Schmitz et al. suggest NIPD may be misused for sex selection. First, sex selection, and other non-medical uses of prenatal testing, may not always be ‘misuses’, a point we cannot expand further here. Second, this is not unique to NIPD and adopting such a precautionary stance would necessitate withdrawing all prenatal testing since this too may be subject to abuse. Third, the majority of NIPD would be used by women with wanted pregnancies; just because NIPD could be used to discover trivial facts this does not mean women would terminate for these reasons. NIPD may provide definitive information quickly, early and relatively easily for conditions currently tested for at the risk of miscarriage. Any disability stigmatisation that accompanies this should be taken seriously, but NIPD would not offer any new dimension to this issue and, given the morally significant advantages that are likely to come with NIPD, this is not a sufficient reason to prevent access to this technology. We agree with the authors that good counselling is an important element to autonomous decision-making in all prenatal testing and that the removal of test-associated risk may have implications for women’s justification for refusing testing.[1] There is evidence to suggest routinisation of NIPD may lead to an erosion of autonomous decision-making;[2] but this should be tackled by putting in place rigorous professional education procedures to encourage choice. Schmitz et al.’s scenario in which ill-informed women suddenly find themselves having to make a decision is unrealistic. Across Europe the introduction of NIPD would be embedded within a framework of comprehensive practitioner education and development of clear and balanced information for women and couples making decisions in pregnancy.[3][4] [1] Newson AJ. Ethical aspects arising from non-invasive fetal diagnosis. Semin Fetal Neonatal Med 2008;13:103-8. [2] Van den Heuvel A, Chitty L, Dormandy E, Newson A, Deans Z, Attwood S, et al. Will the introduction of non-invasive prenatal diagnostic testing erode informed choices? An experimental study of health care professionals. Patient Educ Couns [Epub ahead of print 2009 June 26]. [3] Chitty LS, van der Schoot CE, Hahn S, Avent ND. SAFE-The Special Non-invasive Advances in Fetal and Neonatal Evaluation Network: aims and achievements. Prenat.Diagn 2008;28(2):83-88. [4] RAPID project: Reliable Accurate Non-Invasive Prenatal Diagnosis (www.rapid.nhs.uk). Competing interests: None declared |
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Jane Fisher, Director of UK Charity Antenatal Results and Choices (ARC) 73 Charlotte Street, London, W1T 4PN
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ARC is the only UK charity providing non-directive information and support to parents before, during and after antenatal testing and when an abnormality is diagnosed in an unborn baby. While we entirely agree with Schmitz et al that the implementation of NIPD must be accompanied by high quality and timely pre-test counselling, we feel they overplay the ethical pitfalls. ARC has over twenty years’ experience of talking to parents on our National Helpline on all aspects of antenatal testing and its aftermath. Our most common call is from parents wrestling with the decision about whether to have an invasive diagnostic procedure. They agonize over whether to put their pregnancy at risk in order to have conclusive information on a genetic condition; not all would consider a termination, but simply need to have a definitive answer. Many come to us desperate to know if there is a risk-free alternative. From our experience we can predict that if NIPD were to provide safe but reliable diagnoses of aneuploidy and other genetic conditions it would prove popular with many parents and ARC would welcome such a technological breakthrough. For most parents the earlier reassurance that NIPD could bring will be welcome. But for those who are given a positive diagnosis, the decision about the future of what is most often a wanted pregnancy is difficult regardless of gestation. Even early in the first trimester parents will almost always refer to their baby rather than a fetus. They are well aware of the ethical dimension of the decision to have a termination as they know they will live with this choice. Furthermore, there is no evidence that earlier terminations for fetal abnormality have substantially less long term emotional impact on women and couples than those carried out later in the pregnancy.1 There is a precedent for a non-invasive diagnostic tool in routine use in antenatal care, namely ultrasound scanning. Every time an ultrasound probe is placed on the abdomen of a pregnant woman there is the possibility that an abnormality will be detected. Although information provision to women about the purpose of antenatal ultrasound has improved, we cannot underestimate the profound impact on parents when the scan shows that there is something wrong. However well-informed a woman may be, such news will always come as a shock and generate considerable anxiety and distress. This will also be the case for a diagnosis made from NIPD, even if it comes earlier in pregnancy and even if they have been fully informed of the potential consequences before undertaking the procedure. Just as ARC does now in the context of obstetric ultrasound, along with good pre-test counselling we would advocate the implementation of carefully co-ordinated non-directive care pathways when NIPD reveals an affected pregnancy. If this happens, we do not share the view expressed by Schmitz et al that a woman’s reproductive autonomy will be under threat. References 1 Statham, H. "Prenatal diagnosis of fetal abnormality: the decision to terminate the pregnancy and the psychological consequences." Fetal and Maternal Medicine Review 13: 213 - 247. 2002 Competing interests: None declared |
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Dagmar Schmitz, Postdoctoral Researcher Institute for History, Theory and Ethics in Medicine, RWTH Aachen University, 52074 Aachen, Germany, Wolfram Henn and Christian Netzer
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The Rapid Response of Deans and Newson gives us the opportunity to emphasize some fundamental points of our commentary and also to clarify some misunderstandings: First, we did not state that termination is the typical goal of prenatal diagnosis, but providing the option to terminate a pregnancy with an affected fetus. Without such an option, there would not be much to decide about for the pregnant woman and no informed decision-making to be facilitated. Second, Deans and Newson stated that most ethical issues we appeal to are concerning prenatal diagnosis in general. And indeed all issues which Deans and Newson cite (like misuse for sex selection, like balancing the rights of the fetus) have been named in the short second paragraph about general ethical issues in prenatal diagnosis in our commentary. We did not state that they are in any kind special for NIPD and therefore cannot understand their criticism concerning this point. We do think, however, that NIPD is special with respect to the autonomy of the pregnant women, a fear which according to Deans and Newson is unrealistic. We cannot follow them in this regard without ignoring empirical evidence about the quality of informed consent in currently available prenatal screening procedures [e.g.1-4]. In our view, it would be unrealistic not to address autonomy-related questions thoroughly and with great caution when implementing NIPD - a new technology which (as we stated in our commentary) under certain circumstances can indeed be a helpful and promising new option for pregnant women. [1] Bundeszentrale für gesundheitliche Aufklärung (BZgA). Experience of Pregnancy and Prenatal Diagnosis 2006, Köln 2006 (http://www.bzga.de/?uid=65b3be1ef3c2cf6e769c1462034eca10&id=medien&sid=88&idx=1496) [2] Gourounti,K. & Sandall,J. Do pregnant women in Greece make informed choices about antenatal screening for Down's syndrome? A questionnaire survey. Midwifery 2008; 24:153-162. [3] Favre,R. et al. How important is consent in maternal serum screening for Down syndrome in France? Information and consent evaluation in maternal serum screening for Down syndrome: a French study. Prenat. Diagn. 2007; 27:197-205. [4] Dahl,K., Kesmodel,U., Hvidman,L., & Olesen,F. Informed consent: providing information about prenatal examinations. Acta Obstet. Gynecol. Scand. 2006; 85:1420-1425. Competing interests: None declared |
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Antina de Jong, PhD researcher Maastricht University. Faculty: Health, Medicine & Life Sciences; Dept: Health, Ethics & Society
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Dear Editor, The evolving possibility of early, safe and easy non-invasive prenatal diagnosis (NIPD) raises several ethical issues, among which in particular the aspect of informed consent has recently been addressed in the BMJ. Schmitz, Henn and Netzer assert that NIPD may especially undermine informed consent if it is offered on a broad scale (1). It is feared that, as a result, NIPD might threaten autonomous reproductive decision making by pregnant women. To avert this pitfall, they suggest a two step approach for NIPD. Wright and Chitty also raise the issue of informed consent and mention an experimental study that shows health care professionals to be less likely to obtain written informed consent prior to NIPD when compared to (current) invasive prenatal diagnosis (2). Informed consent is generally acknowledged to be a prerequisite for any prenatal test. Nevertheless, failures to meet this prerequisite for current prenatal testing have been reported manifold, even in two step testing procedures (3,4,5). Given these failures, it should be determined whether the requirement of informed consent will be enforced if necessary or if noncompliance with this requirement will be tolerated in practice. If its actual assertion is refrained from, I consider it to be very unlikely that a future suboptimal implementation of informed consent for NIPD can be precluded. The ultimate question therefore seems to be to what extent the requirement of informed consent is really valued and upheld. Formerly revealed shortcomings have, to my knowledge, never been counteracted with drastic re-establishing measures. In this respect, it may be worthwhile to look at other ways of dealing with failing quality standards, like in the Senseo®-recall earlier this year (6). In the Senseo®-case some series of this one-cup coffeemaker appeared to have an electrical fault, leading to a chance of less than 3 in a million per year that the boiler would burst and cause injury to the customers. “Because it matters very much to Philips to guarantee its customers welfare” (7) it was decided to have all (several million) these coffeemakers recalled and repaired or replaced. Of course a cup of coffee is incomparable with a prenatal test as regards complexity and impact, but a comparison may still be fruitful. Whereas the aim of a one-cup coffeemaker is to make consumers safely enjoy a nice cup of coffee and not to be blown in the face and injured by it, the aim of prenatal testing is to enable pregnant women to make autonomous reproductive decisions and not to be smacked in the face by unwanted choices about their pregnancies. The possible harm caused by disregarding the requirement of informed consent can be even more than the physical harm by the defective coffeemaker. Even if this failure occurs less than 3 in a million times per year - which it doesn’t. The question should therefore first and foremost be who will enforce, if necessary, the prerequisite of informed consent for any prenatal test, and how this will be done. The coffee-case had a Mr. Philips to intervene: who will be the vindicator in the prenatal case? References (1) Schmitz D, Henn W, Netzer C. No risk, no objections? Ethical pitfalls of cell-free fetal DNA and RNA testing. BMJ 2009; 339: b2690. (2) Wright CF, Chitty LS. Cell-free fetal DNA and RNA in maternal blood: implications for safer antenatal testing. BMJ 2009; 339: b2451. (3) Schmitz D, Netzer C, Henn W: An offer you can't refuse? Ethical implications of non-invasive prenatal diagnosis. Nat Rev Genet 2009; 10: 515. (4) Green J, Hewison J, Bekker H, Bryant L, Cuckle H: Psychosocial aspects of genetic screening of pregnant women and newborns: a systematic review. Health Technol Assess 2004; 8. (5) Marteau TM, Dormandy E: Facilitating Informed Choice in Prenatal Testing: How Well Are We Doing? Am J Med Genet 2001; 106: 185-190. (6) www.reuters.com/article/pressRelease/idUS159464+15-Apr- 2009+PRN20090415. (7) www.philips.nl/service/senseo/index.page. Competing interests: None declared |
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