Personal Medicine, Public Bioethics
Helping America Respond to Changes in Biotechnology and Health Care
Although we cannot predict the future, we can be certain that advances in biotechnology and medicine will continue to pose ethical dilemmas. Over the past generation, America has faced many bioethical problems: decisions about life-sustaining treatments such as ventilators, kidney dialysis, and organ transplantation; research with human beings; genetic discoveries; public health emergencies; stem cell research; and cloning. We will continue to confront similar issues in the future, and the next administration needs the best advice possible to make informed policy choices that help Americans live safer, healthier lives.
A National Bioethics Advisory Council can help the American public and the new administration understand the ethical issues and choices that new biomedical advances present and think through the appropriate policy responses. Now is the time to consider this new national Council because the charter for the current President’s Council on Bioethics expires next year and the incoming president will have the opportunity to form a new advisory body. The new Council can identify policy options, explain their pros and cons, and make recommendations to policymakers.
In addition to giving advice to the president, the Council should be addressing the nation.
One particular arena in which the next administration will need excellent bioethical advice is personalized medicine—including the burgeoning field of direct-to-consumer genetic testing. Sitting at home, consumers can now order online DNA analyses that include 500,000 of their base pairs. Next year, at least one company will offer to sequence a person’s complete DNA code—3 billion base pairs—for $5000, and that price will soon fall to $1000. Such unprecedented genomic information creates intriguing possibilities for personalized medical care and preventive services. For instance, people may learn if they have genes that predispose them to common diseases, or genes that predict their responses to specific medications. But these scientific advances inevitably raise serious questions about how such knowledge may be used. Are these test results valid and are recommendations for medical care based on them sound? Do consumers understand the limitations and risks of personalized DNA testing, and will they be able to access trustworthy and comprehensible information to help them understand their results?
From a public policy perspective, this raises critical questions. What conditions and restrictions should be placed on using such genomic information for other purposes, such as research or targeted advertisements to clients? Furthermore, do direct-to-consumer genetic testing companies adequately protect the confidentiality of this sensitive personal information? Current state and federal laws and regulations protecting the confidentiality of health information may not apply, for example if these companies are not considered health care providers.
The National Bioethics Advisory Council can clarify these policy questions and make policy recommendations. Voluntary guidelines for such testing or a system of certification for these companies might provide important protections. Regulatory agencies may need to clarify how existing laws and regulations apply to these new activities. Some modification of laws and regulations also may be needed. Finally, the Council could recommend areas where research is needed to provide a sound evidence base for future policy decisions. Ultimately, individuals and their families will make decisions about using such new testing. The Council could recommend points for them to consider and suggest how public interest groups might provide education and advice.
But the advent of personalized genetic medicine is not the only advance that requires grappling with significant bioethical issues. In a similar manner, innovations in electronic medical records offer potential benefits to patients but pose dilemmas in how the information might be used and protected. Personally controlled health records allow patients to add information to their electronic record and determine who has access to it. Using these digital health records, patients may coordinate care from different doctors and hospitals, receive targeted information on the Internet about their condition, access disease management programs and research studies, and join social networks of people with the same medical condition. But will these records be accurate and complete? Will patients learn a grim diagnosis like cancer from reading test reports in their records rather than from their physicians? Will these records be used to send misleading advertisements of medical products and services targeted to patients? Because patient-controlled records are not covered by current federal health privacy regulations, questions will arise about the security of the medical information. And will this technology exacerbate the “digital divide” between the wealthy and poor, worsening socioeconomic disparities in health care access and outcomes? These sorts of questions could affect virtually anyone who receives health care in this country. Again, a National Bioethics Advisory Council can provide insights and advice.
In addition to giving advice to the president, the Council should be addressing the nation. The Council should reach out to the American people, for example, by inviting testimony from community organizations and patient and public advocacy groups, soliciting public comments on draft proposals, and responding to criticisms by explaining the reasons why suggestions were not accepted. Further, a new council could approach communication with the public as a two-way street. Rick Borchelt and Kathy Hudson have argued here on Science Progress, “the end game of public engagement should be empowerment: creating a real and meaningful mechanism for public input to be heard far enough upstream in science and technology policymaking and program development to influence decisions.” Using the Internet to summarize and respond to public comment may be one way to hold ongoing discussions.
The president and the nation need expert, thoughtful, balanced advice. On difficult bioethical issues, various constituencies often start from very different perspectives. The National Bioethics Advisory Council should take a fresh and critical look at evidence, assumptions, and arguments. Its conclusions should not predictably confirm any preconceived ideological perspective. Members of the Council, as well as the public, should be willing to learn and to reconsider their own views.
The next administration will need to implement a new vision of the role of the federal government in many areas, including biotechnology and medicine. Some people fear change brought about by scientific discoveries and the uncertainty that accompanies new knowledge. Some may fear change so much that they close off the possibility of learning from it and harnessing it for the country’s benefit. A National Bioethics Advisory Council can help the country understand biomedical innovations and their implications, correct misconceptions, and acknowledge concerns. It can also stimulate discussions among the American people on these issues, so that policy development happens in dialogue with the citizens the government serves.
Bernard Lo, M.D. Is Professor of Medicine and Director of the Program in Medical Ethics at the University of California San Francisco. He is National Director of the Greenwall Faculty Scholars in Bioethics Program. He is a member of the Institute of Medicine and serves on the Institute of Medicine Council. He served on the National Bioethics Advisory Commission convened by President Clinton.
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