Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process - Journal of Obstetrics and Gynaecology Canada
Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process
Blake Murdoch, JD, MBA
,
Vardit Ravitsky, PhD
,
Ubaka Ogbogu, SJD
,
Sarah Ali-Khan, PhD
,
Gabrielle Bertier, MIR
,
Stanislav Birko, BSc
,
Tania Bubela, JD, PhD
,
Jeremy De Beer, BCL
,
Charles Dupras, MSc
,
Meika Ellis, BSc
,
Palmira Granados Moreno, LLM
,
Yann Joly, PhD
,
Kalina Kamenova, PhD
,
Zubin Master, PhD
,
Alessandro Marcon, MA
,
Mike Paulden, MSc, PhD
,
François Rousseau, MD, MSc
,
Timothy Caulfield, LLB, LLM
DOI: http://dx.doi.org/10.1016/j.jogc.2016.09.004
Abstract
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.
Résumé
Le dépistage prénatal non effractif (DPNE) est une technologie remarquable ayant le potentiel d'offrir une multitude d'avantages cliniques, notamment une réduction des fausses couches, grâce à la diminution du nombre d'examens invasifs. Cependant, certains soupçonnent que les avantages économiques et cliniques à court terme du DPNE ont été surévalués, et ses limites et méfaits, minimisés. Il y a donc lieu d'étudier de quelle façon les pressions sociales et les politiques influencent l'application concrète, la mise en œuvre et l'utilisation d'innovations en soins de santé comme le DPNE. Malgré les réserves quant à son rapport coût-efficacité, le DPNE est souvent présenté comme un premier palier d'examen qui devrait être offert à toutes les femmes enceintes. De nombreux facteurs ont contribué à un environnement translationnel problématique au Canada, poussant à l'adoption de cette technologie comme premier palier d'examen. Les gouvernements ont exercé des pressions pour qu'on commercialise le DPNE, en présentant le secteur de la recherche financée par les deniers publics comme un possible moteur de croissance économique. Afin d'optimiser la taille de leur marché, les acteurs du secteur ont tout avantage à défendre la valeur clinique de cette technologie pour en vanter les bienfaits pour le plus grand nombre de personnes possible. Nombre d'études sur le DPNE ont été réalisées et financées directement par le secteur privé dans des laboratoires sans supervision indépendante adéquate. Par ailleurs, la crainte pour les médecins d'être tenus responsables s'ils ne recommandent pas un DPNE à leurs patientes peut aussi provoquer l'adoption généralisée de la procédure. Combinée à ces pressions de mise en application, la forte adhésion sociale pourrait mener à une « systématisation » du DPNE et, par conséquent, nuire à l'autodétermination reproductive des femmes. C'est pourquoi les décideurs devraient, avant de prendre des décisions relativement au financement public du DPNE, exiger des preuves solides et indépendantes sur sa pertinence clinique et sanitaire dans leur province ou leur territoire.
Key Words:
Commercialization, obstetrics, prenatal screening, gynaecology, ethics
Public Health Genomics Knowledge Base (v1.2)
Last Posted: Jan-06-2017 0PM
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Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process
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