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Stem Cells: The Rush Is On

man panning for gold finds cell cluster

A scientific breakthrough in South Korea and political initiatives from Washington to California could make it easier for American researchers to explore the life-saving potential of embryonic stem cells. And though treatments may be at least a generation away, proponents are now moving quickly to confront the thorny ethical and financial issues that surround stem cell research.

In late May scientists in South Korea reported in the journal Science that they had devised a streamlined method for reproducing embryos and extracting stem cells. They stressed that the procedure, known as therapeutic cloning, is intended not to clone babies but to replicate cells that may be able to repair or replace tissue damaged by injury or disease. [See box on right.]

Within days, the House of Representatives passed a bill, with bipartisan support, that would allow the use of embryos discarded from fertility clinics. President Bush pledged to veto the measure, which would overturn his policy banning research on embryonic stem cell lines that did not exist before Aug. 9, 2001.

Supporters of the research, who believe stem cell therapies can treat conditions such as diabetes, Parkinson’s and multiple sclerosis, hailed the latest developments. "All of this shows that you can’t bury your head in the sand and stop medical progress," says Daniel Perry, executive director of the nonprofit Washington-based Alliance for Aging Research. "We’re thrilled to see a bipartisan consensus in Congress. Ideally, our country should once again become a research leader rather than a follower—with all of our experiments conducted under strict nationally mandated ethical standards. The public has the right to expect nothing less."

But opponents stood firm against research in which embryos are destroyed. Alfonso Gomez-Lobo, a member of the President’s Council on Bioethics and professor of metaphysics and moral philosophy at Georgetown University, says, "Once you have a cloned human embryo, you can do two different things with it—implant it or destroy it. Do we want a society in which laboratory technicians make that decision?"

In an e-mail to the New York Times, council chairman Leon Kass, M.D., described the Korean breakthrough as "morally troubling," arguing that the research not only makes it easier to clone babies but "exploits women as egg donors not for their benefit."

In fact, the National Academies, an independent group of top scientists and ethicists who advise the government on science and public health policy, addressed some of those concerns in April when it issued the first comprehensive ethics guidelines for stem cell research. The guidelines are intended for states and private institutions that are financing such studies. Though voluntary, the rules were welcomed by institutions that are normally advised by the National Institutes of Health.

The guidelines prohibit not only the cloning of human beings but payments to egg donors or the use of eggs without the donor’s informed consent. But therapeutic cloning to culture new stem cells—along the lines of the South Korean research—is permitted. Only the earliest embryonic cells have the potential to turn into almost any type of tissue. Adult stem cells are useful but believed to be less versatile and thus less promising for research.

Therapeutic cloning is permitted under Proposition 71, a landmark initiative passed last November in California. Voters there agreed to spend $3 billion of their tax money for embryonic and adult stem cell research. They also spurred other states—Connecticut, Illinois, Massachusetts, New Jersey, New York and Wisconsin among them—to set up their own programs or increase their spending for stem cell studies. Although profits are still far in the future, regions that take the lead in high-tech research stand to make millions, even billions, when jobs, construction of research institutes and new tax revenue are taken into account.

Miriam Piven Cotler, a medical ethicist at California State University in Northridge and the University of California at Los Angeles, who supported Proposition 71, says the amount of money at stake, as well as the politicization of the issue, "makes it crucial to step back and talk about these issues not in terms of special interests but [within] a broader concept of justice."

That’s exactly what the drafting committee for the National Academies had in mind. In announcing the guidelines, committee co-chair Jonathan D. Moreno, director of the Center for Biomedical Ethics at the University of Virginia, said that in many instances the Academies had set the bar higher than existing ethics regulations on research.

Even in the absence of federal guidelines, states and the private sector have forged ahead. The urgency of California’s effort was underscored by a study conducted by the Salk Institute in La Jolla, Calif., and the University of California at San Diego. In a report published in Nature Medicine in January, researchers concluded that all the Bush-approved cell lines are contaminated with mouse molecules that could set off an attack by the human immune system—and thereby render treatments with those lines useless and dangerous.

What sets the California research effort apart from other state programs, which are typically established by legislation or executive order, is that voters approved it, thus creating strong public pressure to get the new California Institute for Regenerative Medicine up and running as soon as possible. The first research grants were expected to be awarded in May but were delayed until some of the most prickly issues are addressed. Some of the questions in California are sure to arise in other states as well. Among them:

  • Who owns the intellectual property rights to discoveries based on publicly funded research — and who will profit from any future therapies that emerge? Supporters and critics agree that the state must receive a share of profits from taxpayer-financed research.
  • How can conflicts of interest be minimized in the awarding of research grants, given the close ties among scientists, biotech companies and universities? Members of grant-reviewing committees in California are prohibited from voting on research proposals that would benefit their own institutions. But Terry Francke, general counsel for Californians Aware, a citizen watchdog group, says that’s not good enough. " The web of connections in this world is just too cozy when you’re talking about this much tax money, " he says.
  • How public should the process be? Do taxpayers have the right to know the nature of specific scientific research projects and the reasons for their approval?

Perhaps the most important question is whether the possibility of swift cures for serious diseases has been oversold to a public strongly influenced by the deaths of Ronald Reagan and Christopher Reeve. Opponents of the California program predict that voters will eventually regret spending money on research for what may be a distant payoff.

David A. Shaywitz, M.D., an endocrinologist and stem cell researcher at Harvard University, says that scientists, the media and health advocacy groups should urge the public to be patient.

"In contrast to the tidy tableau of television’s CSI, science in the real world is often slower and messier than we’d like," Shaywitz says. "Ultimately, however, I suspect that embryonic stem cells will evolve into a therapeutic tool even more useful than anything we can now envision. By developing this technology today, we can hopefully establish therapies that will benefit our children and grandchildren in the years to come."

Susan Jacoby is a journalist in New York and author of Freethinkers: A History of American Secularism (2004).

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