Evidence, truth, reality and power: A Foucauldian analysis of the ethics of testing and using novel medical devices

Abdool, Zeelha (2018-12)

Thesis (MA)--Stellenbosch University, 2018.

Thesis

ENGLISH ABSTRACT: From the onset of time, human beings have used substances in all forms and shapes to promote health. Prior to the nineteenth century, traditional folk medicine, religious ceremonies, magical practices, herbs and the balancing of the ‘humors’ were popular methods of healing amongst others practiced by the Greeks. The various earlier Egyptian papyri detail the ancient Egyptian concepts of disease and cures, various ailments and anatomical observations. Informed consent was simplistically manifested by patient trust and cooperation. The nineteenth and twentieth centuries witnessed significant medical advancement is all spheres of medicine i.e. opening of hospitals, training of doctors, era of antibiotics, development of universities and research centres. Since the quest for science and health was a priority, doctors earned a high social standing and began to enjoy the privileged status in society. This resulted in the birth of a heavily professionalized discipline. Developing Michel Foucault’s ideas, we may regard that discipline is a specific technique of power, which aims to objectify human beings using three main practices i.e. dividing practices (e.g. birth of hospitals and asylums), scientific classification (medicine regarded as a discipline) and subjectification of human beings (humans considered as subjects). Using Foucauldian ethics, this thesis aims to deconstruct the power versus knowledge relationship between physicians and the healthcare industry in context of adopting novel medical devices. The last century has been challenged by the invention of medical devices by the healthcare industry. Some of these medical devices have raised both scientific and ethical issues because patients suffered harm. The use of transvaginal mesh for pelvic organ prolapse is currently a global topic questioning how harm came to women. The rationale for mesh development, regulatory clearance and dissemination to society, and conflict with the four ethical principles is discussed. Three other gynaecological devices will also be the focus of this thesis. The power of regulatory authorities to clear medical devices using a substandard clearance mechanism, and the power of the healthcare industry to employ vicious marketing strategies to physicians is critically analysed. Physicians as bodies of knowledge adopt these procedures with noble intentions. The implications of using novel medical devices are significant as physicians represent the final point of care for patients during which informed consent is finalized. The interplay between physicians and the healthcare industry illustrates the clash between the urge to ‘develop’ and market new technology (medical devices in this case) and the ethics of responsibility espoused by physicians to protect against harm, notwithstanding the role of regulatory authorities. Medical device innovation will continue to expand. Physicians aided by sound science and ethical principles have the responsibility to implement safe and efficacious treatment. As this may be not sufficient to prevent harm, the addition of virtue ethics and shifting of the power balance toward physicians is proposed.

AFRIKAANSE OPSOMMING: Vanaf die vroegste tye het die mens van geneesmiddels in alle vorme gebruik gemaak om sy gesondheid te bevorder. Reeds van die antieke Griekse tye en tot die 19e eeu was tradisionele geneesmiddels, godsdienstige seremonies, beroepe op die bonatuurlike, kruie en pogings om die ‘vier humorale stowwe’ in die liggaam te balanseer gangbare metodes. Nog voor die antieke Grieke is in ‘n groot verskeidenheid Egyptiese papyri besonderhede van die antieke Egyptiese konsepte van siekte en genesing, en anatomiese waarnemings opgeteken. Ingeligte toestemming is simplisties as vertroue in die geneser en samewerking deur die pasiënt beskou. Gedurende die 19e en 20e eeue was daar merkwaardige vooruitgang in alle sfere van geneeskunde: hospitale is geopen, dokters na behore opgelei, antibiotika ontdek en ontwikkel, en nuwe universiteite en navorsingsentra het tot stand gekom. Omdat die soeke na wetenskaplike ontwikkelings en gesondheid sosiale prioriteite was, verkry dokters buitengewone en bevoorregte sosiale status. So ontstaan ‘n hoogs-professionele dissipline. In navolging van Michel Foucault se idees kan ons dissipline as as ‘n besondere vorm van magsaanwending beskou. Die doel is om persone te objektiviseer deur middel van drie meganismes: verdelende praktyke (soos die totstandkoming van hospitale en inrigtings), wetenskaplike klassifikasie (om geneeskunde as dissipline te klassifiseer) en die subjektivisering van persone (mense as ondergeskiktes te beskou). Deur aanwending van Foucault se etiese beskouing beoog hierdie tesis om die kennis-mag verhouding tussen geneeshere en die gesondheidsorg bedryf te dekonstrueer met verwysing na die aanvaarding van nuwe implanteerbare geneeskundige toestelle en apparate. Die ontwikkeling van sodanige innovasies oor die afgelope eeu het groot uitdagings meegebring, beide wat betref hul onderliggende wetenskap sowel as etiese kwessies omdat baie pasiënte by wie dit aangewend is benadeel is. Die gebruik van transvaginale maas om pelviese orgaan prolaps te behandel het baie vroue benadeel, en die praktyk word tans wêreldwyd ondersoek. Die rasionaal vir die ontwikkeling van die maas, regulatoriese goedkeuring, die verspreiding na die samelewing , en die inherente konflikte met die vier bekende etiese beginsels word bespreek. Soortgelyke gebruik van drie ander ginekologiese innovasies word ook ondersoek. Die tesis ondersoek ook die mag van die regulatoriese owerhede om sulke toestelle goed te keur, ‘n ontoereikende goedkeuringsmeganisme ten spyt, en die aggressiewe bemarkingsmag van die industrie teenoor geneeshere. Geneeskundiges as kundiges aanvaar hierdie innovasies met edele doelstellings. Die gebruik van hierdie geneeskundige innovasies hou betekenisvolle implikasies in omdat geneeskundiges die finale besluitnemers oor hul aanwending is, en ingeligte toestemming vir hul gebruik verkry.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/104943
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