The following is a sampling of some of the articles and books I have read while writing this blog.
Direct to Consumer Genetic Testing
- Vayena, E. (5 May 2014) Direct-to-consumer genomics on the scales of autonomy. Journal of Medical Ethics Online First. doi: 10.1136/medethics-2014-02026
Dr. Vayena examines the DTC genetic testing controversy from Joseph Raz’s interpretation of autonomy which is “conditioned on…the existence of an adequate range of options and independence from others.” It is a well balanced article presenting arguments both for and against DTC genetic testing with emphasis on the value of the information obtained from such testing and the importance of policy in protecting consumers. Vayena feels there is potential value to DTC genetic testing from a Razian view of autonomy.
- Edwards, K.T., Huang, C.J. (May 2014) Bridging the Consumer-Medical Divide: How to Regulate Direct-to-Consumer Genetic Testing. Hastings Center Report. 44(3): 17-19. doi: 10.1002/hast.310
In this essay the authors argue that while DTC genetic testing should be subject to some oversight to ensure both analytic and clinical validity, it should remain available directly to the consumer and not require medical provider consultation. They feel concerns that consumers might make bad health decisions based in the information provided by these tests are overblown. “Patients chose which health-related advice, including but not limited to drug management advice, to act upon – whether from experienced doctors, well-meaning family and friends, or seemingly absurd sources like horoscopes and psychic readings.” In their eyes, they feel the role of the FDA in such tests should be ensuring validity and facilitating communication between consumers and their clinical providers when test results indicate follow-up is warranted.
- Barazzetti, G., Reichlin, M. (2011) Life extension: a biomedical goal?: Scientific prospects, ethical concerns. Swiss Medical Weekly. 141:w13181. doi: 10.4414/smw.2011.13181
Barazzetti and Reichlin provide an overview of some of the current research into lifespan extension such as caloric restriction, hormone treatment, counteracting oxidative stress, and telomerase activation. They stress that while there is still much to be learned about the aging process and predictions surrounding anti-aging claims are unreliable at this time, we should still consider the implications of lifespan extension from social and ethical viewpoints. In particular, the authors focus on questions of justice: how will lifespan extension impact basic resources such as water and food if there is an increase in population? How will in increase in an older population and a change the ratio between young workers and older people impact the economy and available services? Is it appropriate to “cure” old age while we still combat illness such as infectious diseases or when a large portion of the population wouldn’t have access to such treatment? While no definitive answers to these questions are provided, the authors clearly feel we have an obligation to consider the ethical and social consequences of extending the lifespan as we continue anti-aging and lifespan extension research.
- Schummer, J. (2006) Cultural diversity in nanotechnology ethics. Interdisciplinary Science Reviews 31(3); 217-230. doi:10.1179/030801806X113757
Schummer examines the importance of ethical relativism based on cultural conditions such as language, heritage, economics and politics in the context of discussions of nanotechnology. Comparing the definitional approaches to discussions of nanotechnology, he describes how nominal, real and teleological definitions can change the shape and content of a conversation. Schummer points to the importance of understanding cultural perspectives such as religion and important historical events that can influence public trust or belief in an issue. He also provides an overview of the difference between developed and developing countries and their motivations and concerns about nanotechnology development. For political understanding he compares autocratic, information-plus-debate, and democratic governance and the role of public discourse in establishing policy and regulations, subsidies and national R&D programs and the resulting degree of public support of these programs. Schummer examines the concept of a “good life” and the values of utility and distributive justice and how culture influences our ethical framework. He concludes that while different cultures often hold different values or priorities, these values are not static but can change over time and from case to case, stressing the benefit of understanding and incorporating points of view from other cultures as well as understanding our own cultural connections when discussing issues of ethics.
- Lucivero, F., Swierstra, T., Boenink, M. (2011) Assessing Expectations: Towards a Toolbox for an Ethics of Emerging Technologies. Nanoethics. 5:129-141. doi: 10.1007/s11569-011-0119-x
Lucivero et al discuss tools for ethicists when examining and reflecting on emerging technologies. The authors propose that the rhetoric used in statements of scientific expectation can help ethicists judge the technical feasibility, social usability, and desirability of emerging technologies such as nanotechnology. Their methods offer a framework for discourse of ethics around technologies that may still be mostly speculative. Additionally, the authors caution that while “claims of technological feasibility and societal acceptance may often be too speculative,…by contrast claims of moral desirability as a rule are insufficiently speculative,” pointing out that these claims rarely account for changes in morality over time. The authors feel ethicists should stretch imaginative boundaries to facilitate better deliberation on emerging technologies.
- Resnik, D.B. (2012) Responsible Conduct in Nanomedicine Research: Environmental Concerns Beyond the Common Rule. J Law Med Ethics. 40(4): 848-855. doi: 10.1111/j.1748-720X.2012.00713.x
Over the next decade, we are likely to see rapid growth in nanotechnology as it applies to health care. However there is still concern that we still know so little about nanotechnology and biological interactions. It is not yet possible to say that the materials under study are safe not only for the human participants in clinical trials, but also for individuals involved in the manufacture of these materials, the investigators and research staff, close contacts, or even the general public and ecosystems might be affected by them. These are new areas of concern for medical research and not currently detailed in research practice standards such as the Common Rule for Department of Health and Human Services-funded studies, FDA guidelines for clinical research, or Office of Human Research Protection agreements. Since common risk management principles are hard to apply to nanotechnology at this stage of development, Resnik endorses a precautionary approach to nanomedical research, “society should take reasonable measures to avoid, prevent, minimize, or mitigate harms that are plausible and serious.” He calls on OSHA, NIOSH, and the EPA to begin establishing standards pertaining to nanotechnology. Resnik also outlines the role of institutional review boards in nanomedicine clinical trials. While he feels it is beyond the role of the IRB to assess risks beyond risk to the research participants, he does feel the IRB should be able to recognize the potential for risk and request input from groups with sufficient expertise before approval. He suggests the IRB has an ethical obligation through beneficence, as well as a legal obligation under negligence law, to ensure that clinical trials include reasonable safeguards to minimize risk to third parties.
- Allhoff, F. (2014) Risk, Precaution and Nanotechnology. and
Andorno, R., Biller-Andorno. (2014) The Risk of Nanomedicne and the Precautionary Principle. In B. Gordijn, A.M. Cutter (Eds) In Pursuit of Nanoethics. New York, NY: Springer. 107-145
These two chapters provide an excellent discussion of the methods we use to weigh the costs and values of an issue such as nanotechnology or environmental sciences when it is not possible to have a complete understanding of the issue such as when the all the variables are not know or their interactions too complex to predict. Together, they provide a strong, rational structure for meaningful application of the precautionary principle in nanomedicine.
In ‘Risk, Precaution and Nanotechnology‘, Allhoff defines cost-benefit analysis and precautionary principles, comparing their relative strengths, weaknesses and limitations. He discusses the origin of the precautionary principle and provides examples of its in use in national and international environmental policies. Explaining that precautionary principles must center around an uncertainty or unknowable factor, these principles include a “knowledge condition”, which details the current understanding of the issue, a “damage condition”, which outlines the effect that is to be avoided, and the “remedy”, the course of action that should be taken to avoid the damage condition. How the burden of proof that the knowledge condition leads to the damage condition is met and subsequently valued should be defined by the principle as well. Allhoff concludes that we should not rely solely on cost-benefit analysis or a precautionary principle when evaluation novel technologies, rather that these methods should be used in a complimentary fashion and that our decisions should necessarily be re-evaluated as our knowledge grows and uncertainty decreases.
In ‘The Risks of Nanomedicine and the Precautionary Principle‘, the authors look at four specific examples of risk in nanomedicine: the toxicity of nanomaterials, the growing gap between our ability to diagnose problems (and what our definition of “sick” is) and our ability to treat, the issue of privacy and the confidentiality of personal health information, and the controversy of of biomedical human enhancement. They advocate for critical application of the precautionary principle when decision-making is required in the setting of uncertainty but caution against overvaluing its utility. “Precaution should not be mistaken with prevention,” they argue. They outline six key areas of concern when applying a precautionary principle: 1) Such a principle should only be applied in response to a potential, no known risk; 2) The best scientific advice and understanding should be applied, identifying the specific areas and degree of uncertainty; 3) The principle needs to define specifically what “serious damage” is, this is likely to be a political/cultural determination; 4) The precautions taken to avoid the “serious damage” should be proportionate to the degree of risk and impact or seriousness of the threat; 5) There must be transparency of the risk management and risk assessment processes; 6) The burden of proof is on the agency whose actions may result in the “serious damage” to be avoided, they should establish the nature and extent of any risk and prove they have mitigated unnecessary risk where possible. It is not enough, the authors contend, to propose a precautionary approach. To be effective and meaningful it must be thoughtfully developed and applied.
- Meltzer, C.C., Sze, G., et al. (2013) Guidelines for the Ethical Use of Neuroimages in Medical Testimony: Report of a Multidisciplinary Consensus Conference. American Journal of Neuroradiology. doi:10.3174/ajnr.A3711
Neuroimaging for the purposes of lie detection and prediction of behavior remains controversial. Neither methods of image acquisition or interpretation of data have been standardized yet these images are becoming more common in the courtroom. Juries could thus be influenced by science that has not been clearly established, yet studies have shown that even nonsensical information is interpreted as being more credible when accompanied by irrelevant brain images and data. This article reviews recommendations from the American Society of Neuroradiology and other experts, developed at a 2012 conference, ‘Use and Abuse of Neuroimaging in the Courtroom‘. While we are learning about which areas of the brain are involved in certain moods and behaviors, too little is understood about the role these areas actually play in causality of behaviors (especially retrospectively when a defendant undergoes imaging long after the alleged action), making their use in testimony or in sentencing hearings dubious. But more than examining the specifics of neuroimaging in the courtroom, the article also outlines recommendations for ethical expert medical/scientific testimony that could easily be used more broadly. These guidelines advocate practices including steps to help eliminate bias, ensure expertise appropriate to the issues at hand, encourage peer review, and encourage transparency when findings aren’t validated or when other factors may account for issue under discussion.
Prenatal Genetic Testing
- Donley, G., Hull, SC., Berkman, B.E. (2012) Prenatal Whole Genome Sequencing: Just Because We Can, Should We? Hastings Center Report. 42(4): 28-40. doi: 10.1002/hast.50
Prenatal genetic testing is advancing rapidly and it is likely that prenatal whole genome sequencing will be affordable enough to offer widely in the near future. While this would provide expectant parents a great deal of information about their future children, the authors argue that much of the information has little actual value while at the same time inviting genetic determinism and potentially violating the future autonomy of the children. They propose that testing should be primarily targeted to serious childhood medical conditions and that other testing, if requested by the parent, should be accompanied by careful counseling. For conditions that generally do not present until adulthood and have few if any treatment options (such as Huntington’s), testing should not be routinely offered and an effort should be made to protect the future autonomy of the child and their right not to know. The authors suggest further research be done to assess 1) what kind of information parent find relevant to reproductive decision-making, 2) the balance of harm vs benefit to the child from prenatal genetic testing, and 3) how the health care system will incorporate and accommodate this type of testing.
- Miller, P.S., Levine, R.L. (Feb 2013) Avoiding genetic genocide: understanding good intentions and eugenics in the complex dialogue between the medical and disabilities community. Genetics in Medicine. 15(2): 95-102. doi: 10.1038/gim.2012.102
This article looks at the implications of prenatal genetic testing from the perspective of disabilities communities. Providing historical examples from medicine, science, law and public policy that devalue people with disabilities such as forced sterilization, the authors establish the basis for the fears held by many that new prenatal genetic testing will result in a new push towards eugenics through termination of pregnancies when disabilities are suspected. They contend that this desire for the “perfect baby” devalues the lives of people living satisfying lives with disabilities, portraying them as defective. The long-held and still common paternalistic model in medicine and the common belief that medicine has to “fix” every problem perpetuates the misconceptions that people with disabilities are somehow less than whole. The authors conclude “the best way to balance the usefulness of biomedical and genetic research with concerns about its overuse and abuse is to educate health care professionals about disability and to keep the dialogue open between the disability community and the medical community.”
- Rust, D. (2010) The Ethics of Controlling Population Growth in the Developing World. Intersect. 3(1): 69-78
The world’s population continues to grow, predominantly in developing countries. The growth of the world’s population has a significant impact on our climate and, therefore, on or food supply and health. David Rust proposes that since decreasing the rate of population growth will have the effect of decreasing the gap between rich and poor by decreasing competition for resources, limiting population growth is warranted when examined though the principles of Extreme Paternalism and the Social Welfare Principle. The loss of liberty is outweighed by the benefits to the individual and society as a whole. He does point out that limiting parents from having multiple children may result in an inability of families to meet some basic needs and that foreign aid might be needed; both private and public harm need to be avoided. Passive measures (making contraception and abortion available but not limiting the number of children a family may have) more evenly distribute the burden of reducing population growth than coercive measures (a forced limited number of children) do. Examined from a Rawlsian perspective, coercive measures may be unjust because the developing countries would benefit less than already developed countries and therefore may be morally unacceptable. Even with passive mechanisms, there is the potential for this to be abused in a manner that is discriminatory against certain groups (e.g. gender or race). Violations of human rights may also occur if caution is not used. Rust concedes that to date passive population measures have been fairly ineffective. He recommends stronger incentives and increased availability of contraception options allowing procreative autonomy, allowing the individual to choose which option benefits them more. This is a well balanced opinion examining how and why population growth should be controlled.
Stem Cell Therapy
- Sugarman, J. (2008)Human Stem Cell Ethics: Beyond the Embryo. Cell Stem Cell. 2(6): 529-533. doi: 10.1016/j.stem.2008.05.005
As our understanding of stem cells has advanced, we have moved away from the controversial area of embryonic stem cell use, but that does not mean there aren’t still many areas of ethical concern. Sugarman’s article gives an excellent introduction to many of these topics, with much attention given to the implementation of new therapies and clinical trials in humans. He addresses the need for “robust attention to obtaining meaningful informed consent.” Patients must have a realistic expectation and strong understanding of potential risks when novel therapies are introduced. Some of the other areas Sugarman covers include the right to privacy of genetic information and other patient data that may be revealed, the need to understand ownership of stem cells, and the potential for issues of justice and fairness in the availability of these new resources.
- Zarzeczny, A. Clark, M. (2014) Unproven stem-cell based interventions & physicians’ professional obligations; a qualitative study with medical regulatory authorities in Canada. BMC Medical Ethics. 15:75. doi: 10.1186/1472-6939-15-75 \
Patients are seeking stem cell therapy for a host of medical conditions, but there is little oversight of the industry at present. The authors of this article interviewed representatives from six different provincial Colleges of Physicians and Surgeons in Canada. Each reviewed specific case studies involving stem cell therapy and the interviewers then questioned the participants about novel stem cell therapy and oversight, stem cell tourism, and the physician-patient relationship. The article provides very useful overviews of areas of common concern and the importance of (and limitations of) medical regulatory authorities when establishing policies and standards regarding stem cell therapy and other novel treatments.
- Nisbet, M., Markowitz, E.M. (2014) Understanding Public Opinion in Debates over Biomedical Research: Looking beyond Political Partisanship to Focus on Beliefs about Science and Society. PLoS ONE 9(2); e88473. doi:10.1371/journal.pone.008473
Nisbet and Markowitz examine the factors that influence public support for embryonic stem cell research. Conducting multivariate analysis of influences on public opinion of stem cell research from 2002-2010, they conclude that while political partisanship does have a significant impact on public opinion, a better indicator was an individual’s own beliefs about science and society. Whether someone was a “scientific optimist” with a positive outlook on scientific research and new technology, or “scientific pessimist” expressing skepticism about research and concerns about morality, was the best predictor of their support (optimist) or opposition (pessimist) for embryonic stem cell research. They propose that outreach to the public regarding biomedical research should incorporate discussion of the ethical and moral issues involved with the support of trusted opinion-leaders within the target group. This thoughtful study points out the weakness of relying on political affiliation, religion and education as indicators of support or opposition for all social issues and offers suggestions for further study as well as practical suggestions for improving communication efforts around complex biomedical issues to important target groups.
- Colgrove, J. Bayer, R (2005) Manifold Restraints: Liberty, Public Health and the Legacy of Jacbosen v Massachusetts. American Journal of Public Health 95(4); 571-575. doi: 10.2105/AJPH.2004.055145
In this paper, Colgrove and Bayer review Jacobsen v Massachusetts (1905), a Supreme Court case that found in favor of the state’s compulsory vaccination law. This case has set precedent for many subsequent cases when conflict arises between individual rights and laws that are often seen as intrusive and paternalistic. The authors argue that Jacobson is still relevant today. There is often conflict between the rights of the individual and the collective good of a community. Governments need a framework to balance these concerns. This paper takes on relevance again today in light of the mandatory quarantines enforced last fall during the peak of the Ebola crisis as well as with the outbreak of measles.
- Wilson, J. (2014) The ethics of disease eradication. Vaccine 32(2014) 7179-7183. doi:10.1016/j.vaccine.2014.10.009
Dr Wilson examines why he believes global efforts to eradicate disease are important. He critiques common arguments in support of disease eradication (the symbolic importance of global disease eradication, disease eradication as rescue, and eradication for global public good) and explains why he feels they are not adequate ethical support for disease eradication. Dr Wilson writes that the most compelling reason to pursue disease eradication are the future health benefits that disease eradication provides. The paper gives very clear, easy to understand illustrations that make Dr Wilson’s arguments very easy to follow. It does not cover any area in depth but it does give a good overview of the ethical considerations in support of disease eradication.