UC Berkeley Web Feature
Berkeley bioethicist David Winickoff tackles the really big questions - just don't ask him what bioethics is
BERKELEY – Should scientists be allowed to destroy embryos to harvest stem cells for therapies that might save millions of lives? What if those embryos are cloned from eggs donated by women for research? How about if they are left over from fertility treatments and would otherwise be discarded? Should you have a say in whether your next-door neighbor plants genetically modified crops? Who decided that researchers could patent parts of the human genome?
Law and Order vs. Deadwood
Biotechnology is the Wild West of the 21st century. There's money to be made in them thar cells, and there are precious few sheriffs policing this frontier.
"Many of these technologies are fundamentally unsettling what it means to be human," says Winickoff. "This is something I think societies and the public should have a say in, not just the scientists themselves."
But don't picture the boyish Winickoff in a 10-gallon hat with a silver star. The field of bioethics, he explains, is not about answering yes or no to tricky questions. What it is about, well . that, he admits, he has some trouble articulating.
In between forkfuls of salad niçoise, I read aloud a definition I found on Google. "How's this: 'Bioethics is a discipline dealing with the ethical implications of biological research and its applications. It considers all living organisms and the environment, from the level of the individual to the biosphere.' Does that work?"
Winickoff grimaces. "It's so broad as to be meaningless."
He explains that bioethics was born from ethics, the territory of moral philosophers and theologians, as well as from medicine, shaped by doctors faced with difficult life-or-death decisions. "I'm uncomfortable even calling myself a bioethicist," he says. "I see myself as a legal scholar, a scholar in science and technology studies who explores the ethical, legal, and social aspects of biotechnology."
That's a mouthful, but it's a good starting point. Raised near Boston, Winickoff studied British colonial history as an undergraduate at Yale, with an avid interest in the history of science. After Yale he won a Paul Mellon Fellowship that allowed him to attend Cambridge University for two years, where he picked up a second bachelor's degree, in English.
There Winickoff became fascinated by language, "the discourse we use to codify everything from art to science itself," as he puts it. Facing an academic fork in the road after Cambridge, he took the path to Harvard Law School. "Law seemed to offer both intellectual interest and rigor, and I knew that as a law academic, I could also make a difference in the real world if I wanted to," he explains.
At Harvard, Winickoff's interest in the impact of science on society evolved, and he realized it was a legal area where he really might affect policy. He founded a student group, The Ethics, Law and Biotechnology Society, and began researching topics such as Iceland's Biobanks Act, a follow-up to its controversial Health Sector Database Act, which gave a private company legal access to all Icelandic citizens' health records without informed consent in the traditional sense. (Because of its largely homogeneous population and socialized healthcare structure, Iceland has a highly sought after pool of genetic data.) Icelandic doctors who opposed the Biobanks Act drew heavily on an article Winickoff wrote enumerating its problems from a privacy point of view in order to regulate how the act was implemented. As it turned out, thanks to physician reluctance and the dot-com bust, the countrywide genetics project never got off the ground.
Who gets trampled in the race for a cure?
But other ethically questioned projects have gone forward, such as the California Stem Cell Research and Cures Initiative. Winickoff wrote an editorial for the San Francisco Chronicle in October 2004 opposing Proposition 71, which California voters passed in November to fund the initiative. He wasn't against it for fiscal reasons or questions of ethics; he was bothered by the lack of oversight. The 29-member Independent Citizens' Oversight Committee that will allocate $3 billion in taxpayers' money will be anything but independent, he wrote, and it will have the power to set policies for human cloning technology and human-subject research, as well as allocate patents to the private sector.
That bothers Winickoff. A lot. "Important decisions are being made in the back rooms of university and industry labs that will have huge effects on people and shape their environments and lives," he says. "They aren't open for public scrutiny because they're technical, and it's difficult for people to engage substantively in these issues." He points to the framing of Proposition 71 and the advertising blitz that accompanied it as the opposite of substantive debate.
'I don't envision the answer to these problems is to hold a big open meeting in Berkeley or put yet another proposition on the ballot. But we need a due process for biotech policy.'
"Don't tell me you think we should have a statewide or national vote on human cloning?" I ask, my iced tea halted midway to my mouth.
"No, I don't envision the answer to these problems is to hold a big open meeting in Berkeley or put yet another proposition on the ballot," Winickoff smiles. "But we need a due process for biotech policy. Part of why law is useful is that it's a social technology by which we settle disputes and manage the pluralism that we live in. Within the law there are not just goals and values like keeping speech free, but also ideas about procedural justice - meaning, even if not everyone agrees that an outcome was optimal for their goals, they at least agree that the process was fair."
I finally start to get it: "You're saying we need a biotech Bill of Rights."
"Sort of," Winickoff answers. Quite a lot of existing law, such as property rights, can be adapted and applied to these new issues, but the way it gets applied is sometimes surprising. He looks regretfully at his almost untouched salad - my plate is long gone - before describing the 1990 California case, Moore v. Regents of University of California, which he teaches in his undergraduate class.
A patient with a rare form of leukemia was treated at UCLA's medical center by a doctor who collected many blood, semen, and hair samples from the patient that were unnecessary for his treatment. Five years later, the patient learned that the doctor had collaborated with a biotech company to derive a potentially lucrative cell line from the patient's diseased spleen cells. The patient, understandably, wondered why the doctor and not the patient was profiting from his biological property. The biotech industry and others filed many "friend of the court" briefs with the California Supreme Court, arguing that according property rights to the patient would bring research to a standstill. The court largely sided with the biotech industry, saying that the plaintiff's property rights did not apply to his spleen cells, although he did have a valid (but much less damaging) claim based on the doctor's failure to obtain informed consent.
Winickoff studies cases like this one to trace how decisions were made, how the law is trying to sort the issues out, and then to critique how the law might do it better. He also scrutinizes the power of science over public policy, for example, the appropriate role of technical experts versus elected officials in making decisions about health and environmental regulation and policy. Recently he helped write an amicus curiae brief for the World Trade Organization, recommending that individual WTO member states be given more power to place environmental controls on new genetically modified organisms and that WTO-appointed scientists not be allowed to trump the regulatory decisions of the member states.
Winickoff is decidely a scholar, not a sheriff, but he is a scholar avidly connected to the real world. I let him get in a few bites of tuna and green beans before asking him to apply his research to an area of the biotech Wild West that needs help: the big, ugly mess of stem-cell research.
He puts down his fork reluctantly. "Stem-cell research seems to be a very promising area of research. Personally, it doesn't make a lot of sense to me to treat this early bunch of cells the same as you would a born human. However, because this potentiality is important to many people, it deserves some sort of status or dignity," he says, before going off on an interesting tangent about why he thinks abortion politics have prevented liberals from developing a thoughtful critique about reproductive technologies.
Switching back to the stem-cell discussion, Winickoff continues, "The challenge is, How do we balance the goal of developing therapies that can make a difference to people's lives with respect for religious decisions and the goal of not holding back industry?" The last is an unspoken but very important factor, and the real drive behind Proposition 71, Winickoff argues: the growth of the biotech industry, the creation of jobs, and the expansion of the state's tax base. "These are complicated, messy issues, so if my work can clarify the stakes involved, and suggest procedural ways forward to settle controversy, I would be doing my job."
Now that California's stem cell initiative is under way, Winickoff is proposing a "back-door" strategy that could bring more public accountability to the research than the independent oversight commission is likely to provide. One possible method that California researchers will use to acquire embryonic stem cells is to fuse a donated egg with another cell. Winickoff suggests that these eggs be managed using a charitable trust model.
"Rather than just letting individual women sell eggs, women could actually collectivize first, through contract or informed consent, and say, 'We'll transfer our eggs and go through this procedure, but only if we or our direct representatives get to be involved in the allocation process,'" Winickoff says. "That way, they'd get a say in what grants are made. They could say no to chimeric research, for example" - in which human cells are implanted into animals to make hybrids that have disturbing ethical implications.
I'm struck by the beginning of his sentence. "Women are going to be able to sell their eggs?"
Not exactly, he says. Private companies will be able to reimburse them for all associated costs, and those costs may not be regulated.
"So a bunch of egg donors together could be like the major shareholders in a corporation?" I ask, trying hard not to read the dessert menu the waitress has placed on the table.
More like stakeholders in a charitable foundation, Winickoff corrects me. "You can decide where you donate your money, and once you have, you can usually earmark it for this project rather than that project." Of course, in order for the charitable trust model to work, you'd have to get a sizable number of women together - no biotech research firm wants to have to poll 1,000 individual women every time they want to inject stem cells into a rat vertebra.
Winickoff's proposal makes intuitive sense. Of course, a booming biotech sector that gooses California's economy will benefit everyone, in the trickle-down sense of more money for schools and whatnot. But there's a certain satisfaction in the idea that if a poor woman sells - OK, gives - an egg from which is derived a proprietary stem cell line that makes millions of dollars, shouldn't at least a wee bit of the money roll back into the health care system to fund lower-income residents? How would that inhibit research?
"There are ways to make it more just," nods Winickoff. "I'm trying to find that sweet spot where we have more accountability and control over important policy decisions, where we can allow a certain amount of politics in without undermining the ability to make policy at all."