Ethics panels monitor advances on frontiers of science

Corporations responding to public concerns about biotechnology research

May 28, 1999|By NEWSDAY

The secrets of life are fast becoming big business -- as private research groups and corporations develop and scoop up the rights to scientific discoveries destined to transform medical care and redefine the mysteries of human reproduction.

But amid the wonder over animal cloning and the unraveling of the mysteries of human genetics, some ethicists fear that adequate safeguards are not in place to monitor private research. And, some worry, corporations could charge steep prices for research outcomes, making medical developments -- such as costly tests and procedures aimed at producing babies of a certain gender -- available mostly to the wealthy.

That's why some companies and private research organizations have begun asking medical ethicists to critique their work and ensure that it doesn't violate scientific standards or endanger human rights.

Geron Corp. of Menlo Park, Calif., recently announced that it had bought the Scottish cloning technology that gave the world Dolly, the cloned sheep. Geron issued more than $20 million worth of new shares to buy Roslin Bio-Med, an offshoot of the Roslin Institute near Edinburgh that pioneered the Dolly cloning technology under the auspices of Scottish scientist Dr. Ian Wilmut.

And last November Geron, in collaboration with scientists at Johns Hopkins School of Medicine and the University of Wisconsin, announced that it had licensed research that led to the isolation of human stem cells -- the stuff of life itself.

Geron's stem-cell research and acquisition of the Dolly cloning technology put the company in a position to search for new ways to grow cells, tissue and eventually organs in animals for the purpose of life-saving transplants -- without rejection by human recipients. But, the company acknowledges, with the miracles come risks and questions, and that's why Geron has a five-person advisory board composed of ethicists, trained in philosophical and theological ethics.

Karen Lebacqz, chairwoman of Geron's ethics advisory board, is a professor of theological ethics at Pacific School of Religion in Berkeley, Calif.

Lebacqz says it's the job of the ethics board to keep track of the technological strides Geron is making in order to ensure that they do not pose ethical quandaries.

"It would be well advised for all such companies to do something like this," says Lebacqz. "We are in support of the basic direction [of the work], but we are very aware of a range of ethical issues, which we have now put on our agenda."

Ron Eastman, chief executive officer of Geron, says the company has no intention of cloning humans -- that it will use the Dolly technology combined with its stem-cell research to look for ways to ensure that transplanted organs will not be rejected.

"I think it's quite easy to slip into the sensational aspect of what we're doing," Eastman says. "We are using the fundamentals of human biology to improve the human condition by re-creating human diseases."

Geron hopes to develop significant treatments, perhaps even cures, for certain costly and chronic diseases, including heart disease, diabetes and some forms of cancer, Eastman says. "It would seem to me that biotechnology, with its increasing use of human biology, is going to be in a very strong position to significantly affect human health."

Lebacqz said the ethics board she heads wants Geron to consider exactly how it will control access to its technology and how it will make important medical therapies available to people with few financial resources.

And, says Lebacqz, the ethics board wants to explore the issue of gene enhancement, the temptation to create perfect genes and discard defective ones as scientists proceed with their work. Such a development, Lebacqz cautions, could raise new ethical questions about pursuing perfect humans.

Lebacqz notes that the ethics board is advisory only. "We have no power to get Geron to do what we say," she says.

In Rockville, the Institute for Genomic Research, a private, nonprofit research organization, is also busy probing the genetic secrets of human life. And there, too, ethicists are on board, scrutinizing a key project.

The institute gave a $75,000 grant to study some of its work to the bioethics center at the University of Pennsylvania, led by bioethicist Arthur Caplan.

J. Craig Venter, the institute's chairman, notes that it called a halt to research into the minimal genome -- the smallest bit of genetic material needed to produce a living organism -- so Caplan and company could scrutinize the work and establish an ethics model for future research.

"We knew the work had profound ethical public policy implications, and we decided to set a new precedent and have an ethical review before we went ahead," says Venter. "It's important when you're creating life in the lab or even thinking about it. There was not a compelling reason to go ahead without an ethical review."

George Annas, a lawyer and medical ethics expert at Boston University, is skeptical about the impact ethicists can have on science within corporations and private research groups.

"It's totally unlikely that ethical consultants are going to have an impact on corporate technology if it's going to cost them money," Annas said recently. "The companies are trying to deflect criticism, nothing more. It's a matter of good corporate strategy."

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