Unavoidable Ethical Dilemmas in Bioscience
Margaret R. McLean
Margaret R. McLean delivered this address to the Keck Graduate Institute Convocation in September 2010. She is associate director of the Markkula Center for Applied Ethics and Director of Bioethics.
Drift back in time to that summer between high school and college. Close your eyes and remember the relief of finally finishing high school, the joy of summer heat, the restless anticipation of leaving for college, the dreaded "summer book," that volume that all new students are to read in hopes of creating community, sparking college-level thought, and seeding serious discussion. If I have accessed the correct memory, my entering class at the University of San Francisco read Virgil's The Aeneid, the epic story of Aeneas, a Trojan, who retreated from Troy after it fell to the Greeks and who would later found Rome.1This year, at Santa Clara University, entering students are paging through, "The Open Space of Democracy" by Terry Tempest Williams, a volume of three essays exploring the issues of environmental justice, citizenship, and community. Remember that summer between high school and college and that literary rite of passage.
Now, suppose that you had been given the opportunity to trade that summer book—not for baseball tickets or a day at the beach—but for a simple test that would take you 30 seconds or less to complete—an even trade, the book for the test. Would you do it? Perhaps, but you would certainly want more information about "the test," wouldn't you? What kind of test? Is it graded on a curve? Well, it's a genetic test—actually three genetic tests, which are not interested in your reading comprehension, your thoughts about Aeneas' adventures, or your views on democracy but are concerned with your ability to absorb folic acid, metabolize lactose, and tolerate alcohol. Would you do it? This is the question you would have faced as one of 5000 entering students in the University of California at Berkeley's College of Letters and Science—last year's class read Michael Pollan's The Omnivore's Dilemma; this year's beginners swabbed their inner cheeks for DNA. The plan was to engage students in a discussion of "personalized medicine" by giving them a stake in the outcome—knowledge not of the risk of genetic disease but of traits that can be managed through behavior. Would you do it?
As you mull this over, I want to thank you for your kind invitation to deliver this convocation address. As a (former) research scientist and an ethicist who worries about science (you do know that that is what ethicists do—as one of my colleagues quips: "Ethicists worry so you don't have to!") I am delighted to be at the Keck Graduate Institute, a unique, imaginative, and daring experiment incubated in the traditions of science, that understands—indeed celebrates—that science can only work "for the benefit of society" if it works—and works well—in the real world. This is the genius of this place—an understanding not only of what is required to create competent leaders in science, engineering, and business but also of what it takes to form leaders in the life science industry who are not merely competent scientists with above average leadership and business skills but competent scientists who are ethical leaders, measuring not only their work but themselves with the yardstick of social benefit and the common good. If your only goal was to make something of yourself, you wouldn't be here today—you are here because you want to make something of yourself in order to make something better of the world. You are not only to be welcomed and welcomed back but also to be commended for choosing this place for your graduate education.
I want to begin with a few words from Santa Clara's summer book, The Open Space of Democracy by Terry Tempest Williams, as quoted on the University's website. Williams writes:
"I have always believed democracy is best practiced through its construction, not its completion—a never-ending project where the windows and doors remain open, a reminder to never close ourselves off to sensory impulses of eyes and ears alert toward justice" ("The Open Space of Democracy").2
I am struck by this quote because it puts into words much better than I have been able to do what I think ethics is—allow me to reformulate Williams' words a bit:
I have always believed that ethics is best practiced through its construction, not its completion—it is a never-ending project where the windows and doors remain open, a reminder to never close ourselves off to sensory impulses of eyes and ears alert toward context, change, and justice" (mrm rewriting "The Open Space of Democracy" quote).
This understanding recognizes that ethics is a process, a process for making good, justified, defensible decisions, personally, professionally, and in the public square—ethics is not a destination and the ethical journey never ends. The context for our ethical thinking changes—windows open and doors slam shut and everything appears to be different—yet the questions of good character and right action persist. Eyes and ears are open to change but not merely to change for change's sake—eyes and ears remain alert toward change in the service of justice, change that makes something better of the world. Often we respond to change with reluctance on the one hand and a sense of inevitability on the other. Especially in science and medicine, the default position quickly—and often unreflectively—becomes that we consider what we can do as the template for what we will—or put more strongly, must—do. It seems like such as tiny step from can to will and we are easily seduced by the technological imperative. However, I would argue--and argue strongly--that "If we can, we will" is much too simple a motto for lives as complex as ours in a world as complex as ours. How we use the discoveries that bioscience lays on our doorstep is a choice, a choice that we ought to actively and enthusiastically engage. Despite the magnetism of the technological imperative, it will do nothing to absolve us as scientists and global citizens from the responsibility to decide consciously and reflectively about research and development, safety and efficacy, marketing and price points. In this change-riddled environment, it is no surprise that we find ourselves struggling—personally and professionally—with questions of ethics, questions about what is right-making and wrong-making about actions, motives, and intentions.
Advances in bioscience cause eyes to sparkle, minds to race, and hopes to soar. But along with the "WOW!" come questions—questions such as "why this avenue of research?" and "who will benefit?" and "at what cost?" In fact, it was these questions of "why" and "what for" that led me to leave my work on the effect of immune responses on blood platelet aggregation to pursue a career in bioethics. It is not, however, a so-called "second career" but a single trajectory—medical science and ethics continuously informing and invigorating each other. And, it is the vexing ethical questions of "why" and "what for" and "who for" that you will address, as your professors and mentors have done, throughout your careers—you have no choice really. Questions of ethics permeate questions of bioscience. You will worry about corporate governance and compliance; animal and human subject research; authorship and ownership; conflicts of interest and competition in the marketplace. So, let us reflect, ever so briefly, on five approaches to ethical decision making:
- The first is determining whether what you, or your lab, or your company is about to do results in the greatest benefit and the least harm—both short- and long-term (utility);
- The second is identifying the rights and duties of those participating in and affected by your action or decision (rights);
- The third is determining if those affected by your decision are being treated fairly or justly (equals equally; unequals unequally);
- The fourth is asking whether the community as a whole is being served or only some members of it (common good); and,
- The fifth is considering if an action is helping you to be and become the person you wish to be (character/virtue).
These considerations of benefit and harm, rights and duties, justice and the common good, character and virtue steadily seep into bioscience and have saturated the headlines and the blogosphere during these long summer days:
- A judge rules that federal funds can no longer flow to embryonic stem cell research.
- The direct-to-consumer genetic testing industry is excoriated in a Government Accountability Office report not so subtly titled, "Direct-to-Consumer Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices." 3
- The perhaps too cozy relationship between the Federal Drug Administration and the pharmaceutical industry is placed in the spotlight by the revelation of the prevalence of heart attacks among patients taking a diabetes drug (Avandia, GSK)—47,000 people have suffered stroke, heart failure, or death associated with this medication and, yet, it remains on the market.4
- The state of New Jersey considers a law that would require any person arrested on the suspicion that he or she committed a violent crime to provide a DNA sample—perhaps joining 23 other states that currently collect DNA samples from arrestees prior to conviction or exoneration.5
None of these stories is complete—we will hear much more about stem cells, direct-to-consumer marketing, FDA regulation of the pharmaceutical industry, and forensic genetics. My fervent hope is that we can have careful, serious, civil conversations—free from politics and posturing—about what is at stake in these cases and how best to proceed. It is unwise and likely impossible to predict where our consideration of these thorny issues will end but there is wisdom in recognizing the unavoidable ethical dilemmas placed before us by scientific discoveries and development. Let me merely suggest 5 unavoidable ethical dilemmas raised in the life sciences:6
- Being tempted to "over-sell" experimental results, to promise more than can be delivered (e.g., stem cells)
- Providing adequate protection against unjustified discrimination regarding access to innovative tests, devices, treatments, and other products
- Determining how to provide adequate, accurate, and complete interpretation of complex scientific data to the public (e.g., DTC genetic testing)
- Being tempted to overstate the ability to guarantee "privacy" of sensitive, personal information (e.g., who owns genetic data? Should genetic data become commercially available?)
- Determining the appropriate balance between bioscience innovation and consumer protection (e.g., DTC genetic testing; stem cells)
These and many more bioscience dilemmas merit careful ethical consideration—they are inevitable but not impossible to resolve.
As I conclude, I want to acknowledge a perhaps somewhat annoying trait of ethicists—we often leave you with more questions than answers. That's our job. Our job actually is not to worry for you but to point to things we all ought to worry about and to offer ways to help you worry responsibly about them. The ethics questions raised by 21st century bioscience are tough. Every one of the inevitable dilemmas I've suggested to you today will cause us sleepless nights. If you take nothing else away from my talk today, take this: that we need you in the lab, in the marketplace, in the board room, and especially in the public square—not only because you are becoming confident and competent scientists but also because you will help us think through the complex questions raised by genetic medicine, stem cells, bioprocessing, molecular diagnostics, nanotechnology, pharmaceutical discovery, bioscience business, and a host of advances and quandaries that we cannot even imagine today. We will rely on you as scientists to work with us on the never-ending project of bioethics, where the windows and doors remain open, and we are reminded never to close ourselves off to sensory impulses of eyes and ears alert toward context, change, and justice.
So, which is it—the book or the test?
1Fall of Troy in 1200 BCE.
2Quote from http://www.scu.edu/orientation/summer-reading.cfm accessed 08/2910.
4Calabresi, Massimo: “Is the FDA on Drugs?” Time, August 23, 2010, p. 27.
5 Asher, Colin: “New Jersey Considering New, Stricter DNA Collection Law, but Concerns Remain,” www.jerseycityindependent.com, July 30, 2010.
6 COMMON CONCERNS = access, discrimination, informed consent, privacy, truth telling (exaggerated claims, inadequate or mis- interpretation of complex genetic data), real-world usefulness (clinical utility), ownership of (genetic) data, (acceptable) balance between bioscience innovation and consumer protection, balance between premature availability and avoidable delay