|08-17-2001, 12:43 AM||#1|
Join Date: Jul 2001
Clearer Guidelines Help Britain to Advance Stem Cell Work
August 14, 2001
Clearer Guidelines Help Britain to Advance Stem Cell Work
By NICHOLAS WADE
While American researchers wait for politicians to issue rules on research involving human embryos, scientists in Britain are working under a less restrictive and more predictable system that allows many forms of research on embryonic stem cells and cloning.
For a decade, researchers in Britain have been allowed to create human embryos for research purposes, an idea that was proposed in 1994 by a National Institutes of Health committee, specifically rejected by President Bill Clinton, and widely condemned in the United States when a clinic in Virginia announced last month that it had created scores of embryos expressly for research.
Scientists in Britain also have received approval to proceed with therapeutic cloning, the idea of generating healthy replacements for diseased tissues from embryonic cells derived from the patient's own mature cells. The research is controversial because it takes the same route as human cloning - also known as reproductive cloning - creating an embryo from the adult's cell. But in therapeutic cloning, the embryos, instead of being inserted into a womb to develop into a fetus, would be kept in lab dishes and used to generate embryonic stem cells.
"I have been very impressed with the British system," said Dr. R. Alta Charo, a professor of law and medical ethics at the University of Wisconsin. "They have taken this field forward more than any other country in the world with careful, sequential decision-making, and have created probably the best research environment globally."
The reasons for Britain's less restrictive approach include less intense lobbying from opponents of abortion; a longer track record of research in the area, much of which was pioneered in Britain; an earlier start on the public debate; and a generally respected regulatory authority that oversees both in vitro fertilization clinics and human embryo research.
Congress has just begun to grapple with the issue of therapeutic cloning, and may wind up framing such a fierce ban on human cloning that therapeutic cloning also may be outlawed. The House last month passed a bill that would ban both types of cloning, and was praised by President Bush for having done so.
In Britain, the House of Commons decided after a lengthy debate last December to permit therapeutic cloning, and the House of Lords gave its approval in January.
One reason for Parliament's more adventurous approach is that human embryo research and in vitro fertilization have been intensely discussed in Britain since the birth in 1978 of Louise Brown, the first baby conceived in a test tube. After a decade of debate, and a report prepared under the direction of Mary Warnock, a moral philosopher, Parliament in 1991 set up the Human Fertilization and Embryology Authority, an agency that licenses both fertility clinics and research institutions that study human embryos.
The agency regulates details of clinical practice, such as how many embryos may be implanted in the uterus, and rules on knotty ethical issues such as whether a couple may choose the sex of their baby (yes if for a medical cause, no if for social reasons) and whether a woman may conceive with sperm taken from her dead husband (only if he gave consent before he died).
Scientists in Britain have been leaders in developing techniques for both in vitro fertilization and the generation of embryonic stem cells. The stem cells were first generated from mouse embryos by scientists in Cambridge, England, and this technique was adapted by James Thomson of the University of Wisconsin to generate the first human embryonic stem cells in 1998.
British researchers have also had clearer guidelines for what research is permissible.
"Scientists realize that the confidence the public has in them and the haven in which they do their work is due in part to the fact that we oversee their work," said Ruth Deech. Ms. Deech, a family lawyer and principal of St. Anne's College at Oxford University, has been chairwoman of the embryology agency since 1994.
Dr. Robin Lovell-Badge, an embryologist at Britain's National Institute for Medical Research, said, "I think that generally people are really happy that the regulations are clear and that the way the H.F.E.A. is set up, with a mixture of scientists and ethicists, makes it a very good system to work under."
The agency has permitted five categories of research with human embryos, all related to human fertility. Since 1991 it has allowed 118 embryos to be created for research purposes, Ms. Deech said.
Parliament's decision to allow therapeutic cloning means the agency will now approve a sixth category of research - for studies aimed at generating new human tissues.
A bill to ban human reproductive cloning is pending, but the agency already indirectly controls cloning. In Britain, it is a crime to create a human embryo outside the body without a license from the agency, and officials have made it clear they will not issue one for human cloning.
The agency keeps detailed statistics of the number of human embryos that are created, implanted and destroyed in fertility clinics. Since 1991, a total of 925,747 human embryos have been created and more than 50,000 babies have been born. Human embryos have a high imperfection rate and, as in nature, a clinic must create eight or nine for each successful pregnancy. The surplus embryos are often stored in freezers.
In the United States, each clinic follows its own procedure for disposing of surplus embryos. In Britain, embryos may be stored for only five years, except in special circumstances. Since 1991, a total of 294,584 embryos have been destroyed and 53,497 have been used for research purposes, said James Yeandel, the agency's spokesman. In 1996, when the first legally mandated five-year period came due, there was a "mass destruction" of embryos, Mr. Yeandel said, but since then embryos have been discarded yearly.
Such statistics are not available in the United States because there is no national authority that regulates in vitro fertilization clinics. The lack of statistics on embryo destruction, an inevitable part of the fertility treatment, has enabled opponents of abortion to focus attention on the small number of embryos that would be destroyed to create stem cells, while saying little about the thousands that are discarded by the clinics.
While Mr. Bush has decided that federally financed research must be confined to the already established lines or colonies of human embryonic stem cells, Britain is considering setting up a collection of stem cell lines for research use. The project grew out of a recommendation last year in a report on stem cell research by Liam Donaldson, the government's chief medical officer. A spokeswoman for Britain's Medical Research Council yesterday denied reports that the stem cell bank would be operating in a year.
Embryo research enjoys a more supportive climate in Britain because the abortion debate is not so intense, and members of Parliament are less fearful of single-issue activists than are representatives to Congress, some legal scholars suggest.
"In my view the parliamentary system is better for this kind of debate than the representative system we have in the United States," Dr. Charo said. "There are arguments that a parliamentary system is less democratic because less immediately responsive to the public, but it does allow a conversation to take place at one degree of separation further from the population."
An ethical bedrock of the British agency's operations is Parliament's decision to permit research on human embryos until the appearance of the "primitive streak" some 14 days after conception. The streak, which marks the point at which the embryo changes from a flat disk of cells to a recognizable structure, is regarded by some as the moment when an individual life begins, although others say that life begins at conception.
"Some think the soul enters the body at the moment of fertilization and others don't," Ms. Deech said. "You'll never resolve it so you have to move forward in a pragmatic way, and in a typically British fashion we have reached a compromise that embryos may have research carried out on them."
Britain's early decision to regulate all research on human embryos has had its costs. All research until now has been restricted to issues of fertility, which may be one reason why researchers in Britain failed to translate their lead in developing mouse embryonic stem cells into being first to generate human embryonic stem cells, a step that involves essentially the same techniques.
But the agency's role in overseeing both the fertility clinics and research has helped keep the two issues separate. In Dr. Charo's view, the United States has suffered for not having a national regulator of the clinics.
"The price has been paid in a confusing mixture of therapeutic care and research in these clinics, to the point that many patients are genuinely confused about what exactly they are involved in," she said.