Session Schedule & Abstracts

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Common abbreviations

Symposium: Risk and Precision Medicine

Room: Galerie 3, 2nd Floor   10:30 am–12:00 pm

Chair(s): Gary Marchant

Sponsored by Risk, Policy and Law SG

As the U.S. Government kicks off its Precision Medicine Initiative this year by starting to collect the DNA sequences of one million Americans, and as similar initiatives move forward in other countries, health care is transitioning from population-based approaches to individualized healthcare that focuses on the molecular profile of individual patients. This precision medicine focus will expand beyond prediction, diagnosis and treatment of disease to also include broader health objectives relating to prevention, nutrition and wellness. The transition to precision or personalized medicine raises novel and challenging legal, policy and ethical issues. The four presentations in this symposium will address cutting edge risk communication, risk assessment and risk management issues with respect to precision medicine, addressing issues such as trust, governance, tort liability, and data access and quality.

T2-C.1    10:30 am Genomic Medicine and Malpractice Risks. Marchant GE*, Lindor RA; Arizona State University

Abstract: Liability can be a powerful risk management tool, incentivizing some actors to take adequate precautions, but also potentially impeding innovation and possibly over-deterring some actors. This presentation examines the role of liability, usually in the form of medical malpractice, in managing risks relating to the uptake of genomic or precision medicine by physicians. The study analyzes over 300 cases in which health care providers have been sued for allegedly applying genetic test opportunities or data in a negligent manner, which we refer to as "genomic malpractice." Even though the rate of uptake of genetics in the pursuit of precision medicine has shot up dramatically in the past few years, the rate of litigation has increased at a more modest pace. We document the trends in genomic malpractice litigation, including the types of cases and causes of action brought, and then offer some observations relating to the dynamics of such litigation, including the effects of limited knowledge by professionals in both the medical and legal fields, the important temporal dimension in such litigation, the effectiveness of liability as a risk management approach in the medical technology field, and projections for future liability.

T2-C.2    10:50 am Evaluating Intersections Between Precision Medicine, Risk, and Real World Data in the Context of Rapidly Lethal Diseases. Hartley K*; LSP Group LLC

Abstract: Precision medicine often is applied in the context of rapidly lethal diseases/conditions. The phrase "real world data" (and highly similar phrases) is now used as at least a quasi-term of art in the regulatory framework for major US and EU agencies involved with drugs and devices for use with rapidly lethal diseases. The definitions are not fixed, and can be quite broad. For example, in a 2016 publication, the European Medicines Agency suggested that “real-world data” could encompass any "healthcare related data that is collected outside of randomized clinical trials." In the US, the 20th Century Cures Act of late 2016 explicitly provides for the use of real world data. This project and presentation will bring together information on three aspects of the risks and benefits related to the intersections between use of “real world data” in the context of decision-making regarding rapidly lethal diseases. One aspect of the project will bring together objective information on "real world evidence" definitions now in use by respected agencies and entities for rapidly lethal diseases, and will note the presence or absence of efforts to standardize terminology. A second aspect of the project will be to collect and present information on risks in new legal approaches for regulating use of precision medicine for rapidly lethal diseases. For example, FDA’s approval standard for therapies designated as "breakthrough" when compared to the current standard of care for cancers that are rapidly lethal. The project also will present examples of use of new types of data, such as estimated lives lost due to delays in implementing preliminary or tentative approvals. The third aspect of the project will be to collect and present objective information on risks related to the extent to which “soft law” definitions of real world evidence have been implemented by NGOs for use in substantive areas involving lethal diseases.

T2-C.3    11:10 am Trust in Precision Medicine. Florin MV*; EPFL International Risk Governance Center (IRGC)

Abstract: Trust in precision medicine (PM) is different from trust in conventional medicine, and is needed because of the many, potentially far-reaching, uncertainties and risks that come with its development. Risks can be to individuals who participate in DNA collection schemes, to patients who benefit from new therapies, to insurers and payers, or to industry. Trust in PM is thus far from being limited to trust from individuals and patients. Each actor or process in the system should be trustworthy for what it aims to deliver. Although it is difficult to define indicators and criteria of trust or trustworthiness for each, this is a necessary exercise for the successful development of PM. It is equally difficult to assess whether each actor or process is trusted in a given context or country, because of the complex network of institutions collaborating with each other in a multi-faceted process. The IRGC (International Risk Governance Council and Center@EPFL) organized in 2017 an interdisciplinary and multi-stakeholder workshop on the governance of trust in PM. The presentation will summarize and discuss the main findings from this workshop, focusing on assessing and managing trustworthiness in (a) the collection of genetic, medical and other personal data, and issues of consent about who may access the data; (b) the analysis of data and provision of information for diagnostics that increasingly rely on artificial intelligence; and (c) the provision of health and medical care by professionals to improve prevention and therapies, in ways that should be safe, accessible and affordable to patients. The presentation will emphasize that collaboration between actors, communication and transparency are key, with the aim to reframe and redesign the trust system to accommodate the goal of precision medicine to improve the practice of medicine for patients individually as well as for global health.

T2-C.4    11:30 am Regulating Nutrition IoT. Williams RA*; Utah State u

Abstract: Most nutrition interventions, from labeling to information provision, have largely failed because consumers have been confronted with excessive amounts of information that is complex and often contradictory. In addition, general dietary recommendations don’t necessarily work for all individuals. Private sector diets rarely work beyond the short run and many are designed only to address overweight issues. However, with the advent of big data, IoT and AI, better ways to monitor what is consumed, genetic and health information a new generation of easy to follow, individualized recommendations for eating at home and away in the form of internet of things (IoT) devices is almost upon us. Because these devices will give eating recommendations which can reduce the risk of disease and obesity, there are serious choices that must be made as to how to regulate them. Already, advocates have emerged to champion pre-market approval, as is currently done for prescription drugs and some medical devices. Such an approach would help to ensure that those who wish to take shortcuts to providing advice are kept off of the market. But to do so may increase the financial and chronologic costs of innovation such that there will be a lack of a vibrant, innovative marketplace that could lead to huge improvements in human health.

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