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More than any other area of medical science, embryonic stem-cell research is fraught with ethical controversy. That's because the promising work being done seems so miraculous -- yet so frighteningly close to the origin of human creation.
No surprise, then, that Advanced Cell Technology's announcement on Nov. 25 that it had cloned a primitive human embryo provoked such an uproar. Many bioethicists believe ACT's published experiment was irresponsible. Contrary to the hype, ACT didn't actually clone a full-fledged human embryo, only a very early stage embryo called a blastocyst which was no larger than six cells. The experiment went no farther, yielding no clear medical achievement in terms of advancing research. Indeed, most scientists in the field were hardly surprised at the results and critics immediately called it a stunt.
All ACT really achieved was to renew the furor over developing embryonic stem cells capable of transforming themselves into just about any organ in the human body. Already, Congress is gearing up for more hearings on cloning -- hearings that could lead to suffocating restrictions on stem-cell research.
"CORPORATE HYPE"? That would be a tragedy. True, the experiment dropped what one bioethicist called a "depth charge" on stem-cell research. "We have people in Congress who want to criminalize stem-cell research. So we have to provide substantive, hard-nosed evidence that doing this research can lead to something useful," says Thomas Okarma, CEO of researcher Geron and one of the world's leading stem-cell scientists. "Unfortunately, the ACT paper offers a half-baked result that critics of this science can use to push back the frontiers."
Adds Mildred Cho, a bioethicist at Stanford University: "The announcement by ACT is barely a finding. As far as I'm concerned, it's corporate hype." Says Glenn McGee, a bioethicist at the University of Pennsylvania who resigned last year from a seat on ACT's ethics-advisory panel: "I've spent much of my morning on the phone talking to Republican members of the House who wanted to know if I would help them kill stem-cell research because of ACT's work."
For its part, ACT says it wouldn't have mattered whether it released its findings. "Bottom line," says ACT Research Director Dr. Robert Lanza, "this is an important first step in the field of therapeutic cloning. Nobody here is talking about putting these embryos into a uterus. We're talking about an entity that doesn't even have a single body cell yet. And we're using it to derive stem cells that may be able to save people's lives."
Embryonic stem-cell research simply holds too much promise to toss aside. It could someday lead to immensely beneficial advancements in fighting diseases, from diabetes to heart disease to Parkinson's. And cloning early-stage embryos in order to harvest these stem cells may yield additional breakthroughs.
DISCARDED EMBRYOS. So where do we draw the line? Neither scientists nor politicians have come to terms with the issue yet, but they must form a framework that allows responsible research to go forward while recognizing the moral issues at stake.
One sensible option would be to allow scientists to use only the leftover embryos in fertility clinics, after their rightful owners donate them to science. These are embryos which are destined to be discarded if their owners decide not to have more children. "There are enough of these embryos across the country to carry out a very robust research program," says Eric Meslin, a bioethicist at Indiana University who served as executive director for former President Clinton's National Bioethics Advisory Commission.
For politicians, the task is much tougher. Elected officials will not and should not ignore their own constituents' religious or moral beliefs. So Congress and the President could begin with an outright ban on the reproductive cloning. Such a law wouldn't ban the use human embryos for stem-cell research, but it should proscribe any attempt to implant a cloned embryo in a surrogate mother.
"It's very simple. If you don't transfer a cloned embryo to the uterus, you can't clone a person. So ban reproductive cloning," Okarma says. "What we're doing is therapeutic cloning. We're talking about embryos that are a few days old. A two-day-old embryo is not a person." Yes, some stalwart pro-lifers disagree with that assessment, but a large majority of American might differ.
REDRAWING THE LINES. If a law were to be passed regulating federally funded embryo cloning, who would oversee the field? President Bush could establish a bioethics commission with the job of weighing the potential benefits of research against ethical issues. That way, companies would have a chance to prove they were acting responsibly -- and with a clear therapeutic intent. Companies in the field also could be forced to establish an ethics commission comprised of independent advisers. This would better guard against rogue scientists doing stunts with cloning that lack a clear medical objective.
And Bush needs to reconsider one line he has already drawn: His limits on stem-cell research using federal funds should be scrapped. His executive order Aug. 9 allows federal funds to be used in conjunction with just 60-or-so existing lines of stem cells, not new lines which may be more scientifically advanced.
Geron, the leading stem-cell research company, offers a good example of why Bush's order doesn't make sense. Geron can no longer collaborate with academic labs that receive federal funding when it experiments with the new and cleaner lines of stem cells it recently developed.
IMMENSE POTENTIAL. Okarma makes the further point that, despite ACT's experiment, the future of stem-cell research will not require thousands of women donating their eggs for research purposes or biotech labs sweeping fertility clinics for donor eggs. "One characteristic of embryonic stem cells is that they are infinitely self-renewing. There may be a day when the lines we use degenerate, but for the last two-and-half years we've been using the same four lines. And we know today that you can fill an entire building with embryonic stem cells from a single line," Okarma says.
That's the beauty of embryonic stem cells. They're as close to all-powerful as a biological organism gets. So, if researchers can overcome the problem of immune rejection of stem cells in humans, further cloning experiments such as ACT's may not be necessary. They can simply use a batch of stem cells derived from one of the existing lines approved by President Bush.
It would be a grave mistake if Congress ties the hands of stem-cell researchers. ACT's experiment caught the nation off guard. But it may have caused less anxiety and confusion if a more sensible policy had been in place. Without regulation that allows the research to flourish under well-defined guidelines, the fears of many people who don't trust the science could overwhelm the hopes of the very many others who stand to benefit.
Shook covers the biotech industry for BusinessWeek Online Edited by Douglas Harbrecht
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