Donor Issue Slows Stem Cell Progress

[Guest guest]

Donor Issue Slows Stem Cell Progress

 

By Rick Weiss

 

An ethics crisis at one of the world's most successful human embryonic stem

cell laboratories has plunged the controversial field of research into a new

swirl of uncertainty, with U.S. scientists nervously wondering if the scandal

will grow into a new wave of political backlash.

 

The accusations surrounding Korean cloning expert Woo Suk Hwang of Seoul

National University -- the first scientist to grow stem cells inside cloned

human embryos -- has already killed a spate of planned studies that sought to

prove the cells' medical potential.

 

But the claims that Hwang may have obtained human eggs for his studies from

women who felt pressured to donate are also reigniting a long-smoldering debate

in the United States over the ethics of paying young women for their eggs, which

are difficult to obtain but essential to the production of stem cells tailored

to individuals.

 

Egg donation, which is generally safe but occasionally leads to serious and

even life-threatening complications, has been a wedge issue in the stem cell

debates, linking feminists and other liberal thinkers to conservatives who favor

tighter limits on stem cell research.

 

With a wide range of stem cell bills primed for congressional action as early

as January, the South Korean meltdown could bolster those seeking stronger

limits.

 

" We're in danger of making women into guinea pigs for this research even before

there are any treatments to be tested, " said Marcy Darnovsky, associate director

of the Center for Genetics and Society in Oakland, Calif., a pro-choice public

policy group that favors stronger oversight of egg donation and other biomedical

technologies. " We really need clear rules that someone is enforcing. "

 

The imbroglio erupted a week ago when University of Pittsburgh biologist Gerald

Schatten abruptly severed ties with Hwang, his collaborator of nearly two years,

saying he had evidence that Hwang had obtained human eggs unethically.

 

Schatten's charges resurrected dormant claims of two years ago, when a young

PhD student in Hwang's lab told an interviewer from the scientific journal

Nature that she and another young co-worker were among several women who had

donated eggs.

 

At the time, the student's statement alarmed bioethicists in South Korea and

abroad. It is a widely accepted principle in medical research that junior

members of a research team should not be allowed to be volunteers in studies

because such arrangements cannot be truly voluntary.

 

Concerns about Hwang's experiments were amplified by rumors that the woman had

been paid for her eggs, which could have made it even more difficult for a

struggling student to say " no. "

 

Hwang quickly denied the story. And before long the student did, too, blaming

her poor English for what she said was a misunderstanding. Schatten accepted

those denials until Nov. 11, when he said he had evidence that Hwang had been

dishonest with him.

 

Hwang, who in the past two years has become a major celebrity in South Korea

and been showered with millions of dollars in government grants, again denied

wrongdoing last Monday. But the full explanation that he promised within three

days has yet to be released.

 

This is not the first time Schatten has found himself in the penumbra of an egg

scandal. Ten years ago, revelations about criminal practices at a University of

California fertility program led investigators to Schatten, who was then at the

University of Wisconsin. He had an arrangement to obtain eggs from the clinic in

Irvine, Calif., where, it turned out, doctors were impregnating women with

embryos made from other women's eggs and distributing excess eggs to researchers

without institutional approval.

 

One Irvine doctor was eventually convicted on federal charges, and two others

fled the country to avoid prosecution. Schatten was cleared of any wrongdoing.

 

Schatten's latest close call arose from his 2004 decision to collaborate with

Hwang, who had just succeeded in growing stem cells from cloned human embryos --

a " holy grail " accomplishment that for the first time proved the possibility of

growing stem cells genetically matched to any patient.

 

For Hwang, whose English is marginal, Schatten served as an eloquent

translator, spokesman and a link to the centers of scientific power in the

Western world. For Schatten, whose own stem cell research had foundered, the

deal offered a shortcut to the forefront of one of the hottest fields in biology

and into the international media spotlight.

 

With great fanfare, Hwang and Schatten last month launched an ambitious effort

to distribute hundreds of customized stem cell colonies to disease researchers

around the world -- including U.S. researchers who have been unable to gain

access to such cells under restrictions imposed by President Bush in 2001.

 

In an interview in his Pittsburgh office last month before the deal collapsed,

Schatten's eyes brimmed with tears repeatedly as he talked about the benefits

the project might bring to humankind.

 

The sudden collapse of that endeavor has stunned resource-hungry U.S.

researchers, many of whom had been lining up to take advantage of the South

Korean's techniques and enviable funding.

 

George Daley, a researcher at the Harvard Stem Cell Institute and Children's

Hospital in Boston, had long-standing plans to visit Hwang in Seoul this week,

for example, with the goal of setting up a collaboration.

 

" We want to do it here, but it's incredibly challenging " given state and

federal restrictions on human embryo cloning, said Daley, one of several

scientists expressing fears that the South Korean scandal might take a political

toll on the field. He was still considering last week whether to cancel that

trip in light of Schatten's assertions.

 

More generally, the evolving situation in South Korea has renewed a

long-unresolved debate in this country over the ethics of egg donation for

cloning and stem cell research.

 

With current techniques, it takes dozens of eggs to make a single cloned human

embryo, which is destroyed in the process of extracting the stem cells. That

means that if the field of therapeutic cloning is to advance -- a field

involving the creation of cloned embryos as sources of stem cells that would be

genetically matched to particular patients -- a significant number of eggs will

be needed both to fuel the initial research and eventually to satisfy the

demands of patients.

 

It is legal in the United States to pay women for their eggs, and in recent

years at least two teams of stem cell researchers in Massachusetts have done so

to the tune of thousands of dollars per procedure.

 

Scientists at Advanced Cell Technology of Worcester, Mass., made the decision

to pay women only after a long analysis by an ethics board created by the

company, said scientific director Robert Lanza. He still thinks it is the right

way to go, Lanza said, given the painful injections involved, the uncomfortable

egg suction procedure, and the approximately 5 percent chance of a serious case

of hormonal over-stimulation, which can require hospitalization.

 

Others, however, say such payments cannot help but be coercive, especially for

poor women who might feel compelled to take on those risks just to make ends

meet.

 

In April, the National Academies, chartered by Congress to advise the nation on

matters of science, released a report that recommended against payments for

human eggs beyond expenses incurred by the donors, in part because of the

" sensitivities " inherent in the creation of embryos destined for destruction.

 

But the report's impact remains uncertain as research institutions, fertility

clinics and the biggest wild card of them all -- Congress -- mull the Academies'

findings and the larger issues at hand.

 

At least six stem cell bills -- including one that would allow broader use of

federal funds for the research and another that would allow the creation of

cloned human embryos but would ban payment for eggs -- are awaiting action.

 

Senate Majority Leader Bill Frist (R-Tenn.) has said he intends to get to the

bills early next year.

 

 

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