It's.just.NOT.OK......

from the Ottawa Citizen

The stem cell supply that pits ethicists against geneticists

A debate is raging over the 'millions' of cells held in a Toronto lab

TORONTO - Andras Nagy has created an entire mouse from a single cell. He has also produced fluorescing rodents that glow in the dark.

But these days, the geneticist is more famous for the cells he keeps in an unmarked lab at the end of a long, cluttered hallway at Mount Sinai Hospital.

Behind the locked door are the two batches of stem cells Mr. Nagy grew from cells he extracted from two tiny human embryos. The embryos were destroyed, but their stem cells continue to grow at an incredible rate.

"There are millions of them in here," says Mr. Nagy, removing a tray from a warm, humid incubator. He slips the tray under the microscope to reveal the non-descript clumps of stem cells that impassion both scientists and ethicists, albeit for different reasons.

Mr. Nagy's bosses issued a media release and congratulations when he unveiled the cells, Canada's first two batches of human embryonic stem cells, in June. They say Mr. Nagy's work offers hope for curing chronic and fatal disease. They have also given him scientific approval to create several more stem cell lines from additional human embryos.

But some observers were dismayed to learn about Mr. Nagy's cells or, more specifically, the days-old embryos he used to create them. And two of Canada's leading ethicists have now called for a moratorium on the donation of "fresh," as opposed to frozen, embryos for research until the rules are clarified and better safeguards are in place to protect people undergoing fertility treatment and their embryos.

"It is not OK to just keep pushing the boundaries on what is allowed without involving the public and explaining the reasons for doing so," says ethicist Francoise Baylis of Dalhousie University.

Mr. Nagy is definitely pushing boundaries by doing fresh human embryo research no other scientist in Canada has undertaken. But he stresses that all the work is done in "full compliance" with federal research rules.

If the government decides a moratorium is needed and the rules need revision, Mr. Nagy says he will gladly comply.

Meanwhile, he welcomes the debate. "I am very, very happy because it has to be cleared up," he says.

Mr. Nagy started extracting the cellular contents of human embryos about three years ago. Canadian fertility clinics provided him with the embryos: some were just a few days old and healthy, others were damaged and non-viable, and still more had spent years in the freezer.

The donations are anonymous and made with the consent of people who underwent fertility treatment and decided they no longer wanted or needed the embryos for reproductive purposes.

For his first project, Mr. Nagy says he used several embryos. The aim was to develop techniques for extracting stem cells and nurturing them in the lab. Cells taken from two days-old embryos resulted in the creation of the stem cell lines unveiled in June.

Some people, most notably U.S. President George W. Bush -- who has halted extraction of stem cells from human embryos at federally funded U.S. labs -- are morally opposed to such experiments, saying it is not right to destroy potential human life.

Mr. Nagy is at the opposite extreme. He sees it as a kind of scientific salvation. "I am really happy that I could rescue them," Mr. Nagy says of the potent cells he derived from the embryos, which would have been discarded if not used for research.

Embryonic stem cells can turn into any type of cell in the body, and researchers dream of using them to develop treatments to mend everything from spinal cords to failing hearts and brains. "They have incredible potential," says Mr. Nagy, voicing a viewpoint held by many scientists.

But there are major hurdles to overcome before anyone starts replacing people's heart cells and neurons. One is learning how to coax stem cells to turn into specific types of tissue. Another is to grow stem cells without any animal products.

Many existing human embryonic stem cell lines, including Mr. Nagy's lines, are cultured with mouse "feeder" cells that excrete growth factors, which stimulate stem cells to grow.

As part of his upcoming project, Mr. Nagy plans to use human feeder cells, grown from foreskins snipped off at circumcision. "It's a source now often discarded," he says.

The Stem Cell Network, a federally financed group, has approved his three-year project to create three or four more cell lines. Mr. Nagy cannot say in advance how many embryos will be used, but he says the plan is to use days-old embryos donated for research.

Mr. Nagy has scientific approval and is waiting for the OK from the stem cell oversight committee, which next meets in November. The committee, created by the Canadian Institutes of Health Research, is meant to ensure ethical use of embryos and stem cells.

The problem, say ethicists, is not that Mr. Nagy is necessarily breaking any rules. It's that existing safeguards leave the door open for doctors to ask parents to donate healthy and viable embryos, which are just a few days old. The main worry, Dr. Jeffrey Nisker of the University of Western Ontario wrote in the Canadian Medical Association Journal last month, is that women may be coerced into donating healthy embryos that they could freeze for later attempts at pregnancy.

Normally, doctors advise people undergoing fertility treatment to freeze all spare healthy embryos, which gives the women and couples time to consider whether to try for more children, give the embryos up for adoption, donate them to research or opt for destruction once their families are complete.

Canada's research rules, quietly amended* by the CIHR earlier this year to explicitly say fresh and frozen embryos can be used for research, are "very open ended," says Ms. Baylis.

She would like them to clearly spell out the type of fresh embryos eligible for donation to research.

* my bold ... no discussion or debate ... sneaky bastards.