Murdoch Blake, Ravitsky Vardit, Ogbogu Ubaka, Ali-Khan Sarah, Bertier Gabrielle, Birko Stanislav, Bubela Tania, De Beer Jeremy, Dupras Charles, Ellis Meika, Granados Moreno Palmira, Joly Yann, Kamenova Kalina, Master Zubin, Marcon Alessandro, Paulden Mike, Rousseau François, Caulfield Timothy
Health Law Institute, Faculty of Law, University of Alberta, Edmonton AB.
School of Public Health, University of Montreal, Montreal QC.
J Obstet Gynaecol Can. 2017 Jan;39(1):10-17. doi: 10.1016/j.jogc.2016.09.004. Epub 2016 Oct 17.
Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.
无创产前检测（NIPT）是一项令人兴奋的技术，有潜力带来多种临床益处，包括通过减少侵入性检测来降低流产率。然而，也有人担心NIPT的经济和近期临床益处被夸大，而其潜在局限性和危害却未得到充分重视。因此，NIPT提供了一个机会，来探索一系列社会压力和政策如何影响医疗保健创新的转化、实施和应用。尽管存在成本效益方面的担忧，但NIPT常被视为一种潜在的一线筛查手段，应提供给所有孕妇。多种因素导致加拿大出现了一个有问题的转化环境，形成了将其作为一线检测手段实施的压力。政府将公共资助的研究部门视为经济增长的潜在引擎，从而造成了商业化压力。行业成员为了最大化市场规模，有动机将临床价值描述为对尽可能广泛的人群有益。许多关于NIPT的研究是由私营企业直接资助并在缺乏有力独立监督的实验室中进行的。医生担心因未推荐NIPT而承担潜在责任，这可能进一步推动其广泛应用。广泛的社会认可，再加上这些转化压力，可能导致NIPT的“常规化”，从而对女性的生殖自主权产生不利影响。政策制定者在就NIPT的公共资金投入做出决策之前，应要求提供与其各自管辖区域相关的临床和公共卫生效用的有力独立证据。
