Urologic Oncology: Seminars and Original Investigations 32 (2014) 186
Seminar section introduction
Personalized medicine: An introduction to the ethical challenges Leonard M. Fleck, Ph.D.* Center for Ethics, Michigan State University, East Lansing, MI
Introduction In this seminar, we are identifying and analyzing some of the ethical issues spawned by efforts to personalize medicine through genetic testing and genetic research. Personalized medicine has been presented to the public and to the medical community with much pomp and promise. Some of this enthusiasm is warranted. Genetic research has begun to show why some medicines in some clinical circumstances are very effective for some patients and dangerous or ineffective for others. These preliminary successes have generated the belief that ultimately such research will yield a true science of medicine that is both personal and precise. However, in this seminar, Burke et al. give physicians reason to temper that enthusiasm. They argue that truly personalized medicine must be about much more than expansive genetic testing, and that the precision we would hope for may be more a seductive mirage than a medical miracle. No amount of precise genetic testing will eliminate either the uncertainty that is inherent in every therapeutic effort or the need for trade-offs that will require extensive empathic conversations with patients regarding their personal values and preferences. More genetic information is not necessarily better (ethically or medically speaking). That is a key message in the essay by Wagner et al. Whole-genome sequencing (WGS) is very close to becoming an affordable clinical reality. But the ethical issues can be as massive as the data. There are the privacy risks associated with storing so much data. There are ethical and legal responsibility risks associated with the presumed need to recontact patients should future
* Corresponding author. Tel.: þ1-517-355-7552. E-mail address: fl[email protected]
1078-1439/$ – see front matter r 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.urolonc.2013.08.026
research make clinically meaningful (potentially actionable) data within someone's WGS that had been clinically meaningless when the test was first done. And there are the very complicated issues related to likely numerous incidental findings that may or may not merit a clinical response of some sort. How should responsible and caring physicians address such issues? McGowan et al. expand on the ethical issues identified by Wagner et al. What does informed consent require in discussing WGS with patients who have varying degrees of health literacy? How can the complex risks associated with incidental findings be discussed with patients and meaningfully assessed by them? And what will respect for patient confidentiality mean in terms of what is permitted or required when information derived from WGS has serious potential consequences for various relatives of a patient (and that patient is reluctant to have this information shared with those relatives)? Finally, Fleck calls attention to the social issues raised by expansive genetic testing as the core of personalized medicine, especially in the context of oncology. Will those who are well insured demand access to such testing for their cancer and then demand access to these hyperexpensive targeted therapies that generally yield only very marginal benefits, the consequence being increased inequities in access to needed healthcare for the poor and uninsured? Is it morally relevant that these targeted therapies can be described as “last chance” therapies? Does that generate stronger moral claims to such therapies? If so, why would such claims attach only to the well insured and not the poor and uninsured? Welcome to what I am sure is a provocative seminar.
Seminar section introduction
Personalized medicine: An introduction to the ethical challenges Leonard M. Fleck, Ph.D.* Center for Ethics, Michigan State University, East Lansing, MI
Introduction In this seminar, we are identifying and analyzing some of the ethical issues spawned by efforts to personalize medicine through genetic testing and genetic research. Personalized medicine has been presented to the public and to the medical community with much pomp and promise. Some of this enthusiasm is warranted. Genetic research has begun to show why some medicines in some clinical circumstances are very effective for some patients and dangerous or ineffective for others. These preliminary successes have generated the belief that ultimately such research will yield a true science of medicine that is both personal and precise. However, in this seminar, Burke et al. give physicians reason to temper that enthusiasm. They argue that truly personalized medicine must be about much more than expansive genetic testing, and that the precision we would hope for may be more a seductive mirage than a medical miracle. No amount of precise genetic testing will eliminate either the uncertainty that is inherent in every therapeutic effort or the need for trade-offs that will require extensive empathic conversations with patients regarding their personal values and preferences. More genetic information is not necessarily better (ethically or medically speaking). That is a key message in the essay by Wagner et al. Whole-genome sequencing (WGS) is very close to becoming an affordable clinical reality. But the ethical issues can be as massive as the data. There are the privacy risks associated with storing so much data. There are ethical and legal responsibility risks associated with the presumed need to recontact patients should future
* Corresponding author. Tel.: þ1-517-355-7552. E-mail address: fl[email protected]
1078-1439/$ – see front matter r 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.urolonc.2013.08.026
research make clinically meaningful (potentially actionable) data within someone's WGS that had been clinically meaningless when the test was first done. And there are the very complicated issues related to likely numerous incidental findings that may or may not merit a clinical response of some sort. How should responsible and caring physicians address such issues? McGowan et al. expand on the ethical issues identified by Wagner et al. What does informed consent require in discussing WGS with patients who have varying degrees of health literacy? How can the complex risks associated with incidental findings be discussed with patients and meaningfully assessed by them? And what will respect for patient confidentiality mean in terms of what is permitted or required when information derived from WGS has serious potential consequences for various relatives of a patient (and that patient is reluctant to have this information shared with those relatives)? Finally, Fleck calls attention to the social issues raised by expansive genetic testing as the core of personalized medicine, especially in the context of oncology. Will those who are well insured demand access to such testing for their cancer and then demand access to these hyperexpensive targeted therapies that generally yield only very marginal benefits, the consequence being increased inequities in access to needed healthcare for the poor and uninsured? Is it morally relevant that these targeted therapies can be described as “last chance” therapies? Does that generate stronger moral claims to such therapies? If so, why would such claims attach only to the well insured and not the poor and uninsured? Welcome to what I am sure is a provocative seminar.
