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Remodelling the regulation of postmodern innovation in medicine
Abstract
‘therapy’ is a legal concept of considerable import, traditionally juxtaposed with, but separate from, research and also, to some degree, marking the boundaries of legitimate medical intervention. the recent case of simms highlighted these issues, in addition to which novel clinical interventions were the subject of specific recommendations in the bristol royal infirmary inquiry report. this article subjects the notion of therapy to analytical scrutiny and considers the extent of proper clinician discretion to innovate and, albeit much more superficially, how medicine should itself evolve. it advocates a new, more (patient) protective model which should generate confidence in the ethical character of contemporary innovatory practices.
... 467 While it cannot be assumed that the classification of procedures as novel or off-label exactly tracks their risk profile -and that this profile differs categorically from 'normal' medical interventions 468 -nevertheless a relevant categorisation is seen as an important risk-related factor for the patient to be aware of, to consider and to weigh in their decision-making. 469 One explanation, under Pugh's account, stems from the fact that the provision of some information about risks can aid reasoning, but that an overly complex description of relevant factors does not further, and will in fact hinder, it. 470 Given that a detailed explanation of the (lack of ) scientific evidence or approval, or the mechanisms associated with this, and the different reasons for uncertainty could negatively impact a patient's capacities for reasoning, it is not supportive of autonomy to disclose them. ...
Artificial intelligence (AI) is rapidly being implemented in the healthcare sphere, threatening the ability of patients to make judgments tailored to their personal circumstances and beliefs. This book is concerned with the ability of two legal systems, those of the UK and the U.S., to meet the resulting challenges posed to patient autonomy. It deploys a forward-looking analysis to identify the unique problems raised by clinical AI and to anticipate the responses that are offered by the common law’s doctrine of informed consent. This assessment culminates in a concrete proposal for the regulation of medical AI and an affirmation of the law’s fundamental role in societies’ adaptation to innovative technologies.
... New surgical techniques have traditionally been introduced into clinical care in an unregulated fashion, largely at the discretion of the surgeon concerned. 5 Indeed this is amply illustrated in the advancement of the 'laparoscopic revolution' which was introduced without any formal regulation or control. 6 Similarly, with Endovascular Aneurysm Repair (EVAR), the risk, cost and outcomes of this novel procedure were uncertain at the time of introduction and were quickly adopted, despite a lack of evidence regarding its safety and efficacy. ...
Demand for less invasive surgical intervention has increased in recent years resulting in surgeons occasionally being pressurised into adopting new techniques before evidence of safety and efficacy has been established. Unlike pharmaceutical research, most innovative surgical procedures enter surgical practice without regulatory oversight. This anomaly was recently highlighted in the 'Bristol Report' resulting in a recommendation that unproven therapies or surgical techniques be subjected to ethical overview or independent oversight. When a novel technique is introduced, the surgeon will find himself/herself gaining proficiency and experience on suitable patients. Hence the surgeon embarks on a 'learning curve'. A learning curve can be defined as a graphic representation showing the relationship between experience with a procedure and outcome. Studies demonstrate that learning curves generally 'flatten out' as experience increases, resulting in fewer complications and less of a need to convert to the standard procedure. In addition to lack of regulatory oversight, it is this learning curve that gives rise to many ethical and legal dilemmas. This paper considers the ethical issues relating to a surgeon's candour and clinical equipoise, the legal standard of care in a negligence action and the ethical and legal implications regarding risk disclosure during informed consent. The paper concludes by considering a more patient centred approach where new and innovative therapies are being considered in order to ensure good medical practice and avoid litigation for allegations of negligence or breach of human rights.
Artificial intelligence (AI) is rapidly being implemented in the healthcare sphere, threatening the ability of patients to make judgments tailored to their personal circumstances and beliefs. This book is concerned with the ability of two legal systems, those of the UK and the U.S., to meet the resulting challenges posed to patient autonomy. It deploys a forward-looking analysis to identify the unique problems raised by clinical AI and to anticipate the responses that are offered by the common law’s doctrine of informed consent. This assessment culminates in a concrete proposal for the regulation of medical AI and an affirmation of the law’s fundamental role in societies’ adaptation to innovative technologies.
Some developing biotechnologies challenge accepted legal and ethical norms because of the risks they pose. Xenotransplantation (cross-species transplantation) may prolong life but may also harm the xeno-recipient and the public due to its potential to transmit infectious diseases. These transboundary diseases emphasis the global nature of advances in health care and highlight the difficulties of identifying, monitoring and regulating such risks and thereby protecting individual and public health. Xenotransplantation raises questions about how uncertainty and risk are understood and accepted, and exposes tensions between private benefit and public health. Where public health is at risk, a precautionary approach informed by the harm principle supports prioritising public health, but the issues raised by genetically engineered solid organ transplants have not, as yet, been sufficiently discussed. This must occur prior to their clinical introduction because of the necessary changes to accepted norms which are needed to appropriately safeguard individual and public health.
Developments in medical technology, healthcare delivery, and commercial interests in medicine have increased both the potential
for conflicts of interest on the part of physicians, and doubts over the sufficiency of patient autonomy as a justification
for administering innovative therapy. The legal and regulatory treatment of innovative therapy is therefore an important question,
on which there is a current lack of consensus on a number of issues. This paper discusses recent developments in Singapore
and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment:
the distinction between innovative treatment and clinical research, the adequacy of the current post hoc scrutiny of innovative therapy under existing legal principles and the need for further specialised regulatory oversight.
In a previous paper in this journal I responded to Professor John Keown’s criticisms of the British Medical Association guidance on withholding and withdrawing life-prolonging treatment, arguing that the sanctity of life principle he endorses is indefensible as a juridical and moral guide. Professor Keown replied recently, also in this journal, alleging that I wrongly caricatured the sanctity of life position he supports, which continues to illuminate the proper decision-making path in relation to the withdrawal or withholding of life-sustaining medical treatment. In this present paper it is submitted that Keown’s riposte is misconceived and disguises the true nature of the sanctity of life stance, which both rests upon unconvincing premisses and tends towards unacceptable repercussions, thus leading to its inevitable and rightful rejection.
Traditionally, surgical practice has been experiential and based on the contemporary understanding of basic mechanisms of disease. It was both a science and an art and depended to far too great an extent on the individualism and self belief of its main exponents. "Evidence based medicine" (EBM) emerged in the 1980s and a new gospel of "Rules of Evidence" was introduced. There is no doubt that the net effect of EBM has been beneficial, but over reliance on randomised controlled trials and the lack of generalisability of scientific evidence to individual patients has perhaps led to less enthusiasm for its tenets among surgeons. There are valid and spurious reasons for this that are discussed. The situation is improving but inevitable tensions remain between the surgeon committed to the individual patient here and now, and the clinical researcher whose focus is the benefit of future patients in the larger community.
This Article suggests that the time has come to reconsider the safety and effectiveness of fertility drugs in order to combat some of the continuing problems arising from the overly aggressive use of assisted reproductive technologies, especially the health hazards associated with multifetal pregnancies. After critically assessing the arguments made by some commentators about the power of malpractice law to curb any abuses of fertility clinics and specialists, the Article concludes that the Food and Drug Administration should consider restricting or withdrawing pharmaceutical products used to induce ovulation. Although such a drastic move would not prevent the continued use of in vitro fertilization and other advanced fertility treatments, it would dramatically reduce the frequency of multifetal pregnancies, and it should not run afoul of any constitutional protections of procreative liberty.