The Australian
Matthew Franklin

WOMEN’S groups and federal MPs have warned that legalising therapeutic cloning will endanger women’s lives and create pressure for them to become “egg factories” to supply the dreams of scientists.

And they have accused cloning advocates of playing down the risks in their enthusiasm to convince parliament to scrap a ban on the research procedure.

A coalition of women’s groups including Women’s Forum Australia yesterday launched the Hands off our Ovaries campaign to pressure MPs to reject a private member’s bill, to be debated next month, which would allow cloning.

The procedure involves injecting adult genetic material into an egg that has had its nucleus removed and then harvesting stem cells from the resulting embryo for research and the creation of disease treatments specific to the individual who provided the genetic material.

Speakers at yesterday’s launch said women represented a forgotten element in the cloning debate because scientists would have to inject them with hormones to produce hundreds of thousands of eggs for the research. The hormones had been shown to cause organ failure, respiratory distress and even death.

“Our lives are not collateral damage on the biotechnology superhighway,” WFA spokeswoman Katrina George told the forum. Ms George said egg extraction should be banned until it was shown that eggs could be obtained without risking the health of women.

Ms George also rejected the idea that animal eggs could be used to avoid the need for harvesting eggs from women. While animal eggs might be used in research, human eggs would be needed to produce treatments for humans.

“Because cloning is impossible without women’s eggs, then the health impact on women is absolutely central to this debate,” she said.

“It’s not a side issue.”

By Sandy Kleffman

CONTRA COSTA TIMES

BURLINGAME - The women who donate eggs to California’s $3 billion stem cell research program may take great pride in serving as medical pioneers, but they could also face psychological and health risks that have not been fully explored by scientists, experts said Thursday.

Many of the nation’s top scholars in fertility and women’s health gathered in Burlingame for an all-day hearing to assess how much is known about the risks egg donors face.

Their conclusion: Many questions remain.

“Clearly, we’ve heard that the risk is small,” said Kurt Thomas Barnhart, director of the Center for Clinical Research on Women’s Health at the University of Pennsylvania.

“The problem is defining small or rare.”

California’s stem cell agency asked the influential Institute of Medicine to sponsor the hearing to help it devise guidelines for protecting the women who will step forward in the name of science.

When California’s program kicks into high gear, it is anticipated that scientists will seek eggs from scores of women to retrieve embryonic stem cells. Many people pin great hopes on such stem cells, which can transform into any cell type, as a potential source of therapies or cures for debilitating diseases.

But the crucial role egg donors will play often receives little attention in the heated debate surrounding embryonic stem cells.

The women who volunteer will receive fertility drugs to stimulate their ovaries to produce multiple eggs.

Scientists have some knowledge about the impact of such drugs because they have studied women who use them for reproductive purposes.

Some develop mild to moderate Ovarian Hyperstimulation Syndrome, which leads to abdominal swelling, fluid accumulation and gastrointestinal distress. A very small percentage develop severe cases of the syndrome, which can cause excessive weight gain, respiratory difficulties, and in rare instances, blood clots and kidney failure.

“We don’t know from most of the studies how many of those patients had the risk factors we’ll talk about,” said Dr. Marcelle Cedars, director of the division of reproductive endocrinology and infertility at the University of California at San Francisco.

Women who are young, have low body weight and abnormalities such as polycystic ovary syndrome are at greatest risk of developing hyperstimulation, Cedars said.

While it may not be possible to eliminate the risk entirely, careful monitoring and excluding women who have irregular menstrual cycles and other risk factors can help reduce the severity of problems, Cedars said.

Some people worry that the use of fertility drugs will increase a woman’s long-term risk of developing breast, ovarian and uterine cancer.

Studies to date, however, have shown no evidence that such drugs lead to more breast or invasive ovarian cancer, said noted Dr. Roberta Ness, chairwoman of the epidemiology department at the University of Pittsburgh.

But with cancer of the uterus, “there’s a greater concern” because studies have been too limited to draw conclusions, she said.

Ness and other experts cautioned that scientists need to follow women for longer periods of time because breast and ovarian cancer often show up late in life. Many speakers said a database of stem cell egg donors is needed to track them over time.

California’s stem cell leaders also may consider policies to protect women from depression and other negative feelings after serving as donors.

Studies on women who have donated eggs to infertile couples found that 17 percent to 25 percent later regretted donating or had a negative emotional reaction. Some have complained of feeling like a commodity. Others have worried about having an unknown child appear at their doorstep 18 years later.

Stem cell leaders may want to consider excluding women who have recently had psychological stress in their life from becoming a stem cell egg donor, said Susan Klock, a professor of obstetrics, gynecology and psychiatry at Northwestern University School of Medicine.

Under state law, California’s stem cell agency can reimburse egg donors only for their expenses. The goal is to avoid creating a market for eggs, which could encourage poor women to donate. By contrast, the going rate for donating eggs to infertile couples is $6,000 to $8,000.

California lawmakers have taken steps to heighten protections for women. A bill by Sen. Deborah Ortiz, D-Sacramento, requires that egg donors for stem cell research be fully informed of the risks and provide written and oral consent. It also provides payment for any necessary medical care resulting from the procedure. Gov. Schwarzenegger signed the bill this week.

Another area of concern involves the egg retrieval process, in which women are sedated and eggs are harvested. In rare cases, this can lead to bleeding, infection and damage to internal organs or blood vessels.

In dispelling one myth, the evidence to date suggests that using fertility drugs does not exhaust a woman’s egg supply later in life, said Dr. Nicholas Cataldo of Planned Parenthood of Alabama.

Reported on August 10th. The name of the young woman has not been released. In this case the cause of death may have been bleeding rather than ovarian hyperstimulation syndrome (OHSS), the most frequently occurring cause of death among those from whom eggs are harvested. However, one report did indicate that the bleeding was accompanied by kidney damage. This death is reported to be under investigation by the UK’s regulatory agency, the Human Fertilisation and Embryology authority. Interestingly, several of the reports have erroneously reported that no other deaths from egg harvesting are known to have occurred, or they mention only the most recent one or two deaths. There is no requirement for reporting such deaths in the US so rates are unknown. more

Earlier this year, an international group of scientists and others convened at Hinxton, England (see the related Policy Forum in this issue, p. 921), to address the moral challenges facing collaboration in human embryonic stem cell research that emerge from differences in national laws. Although a focus on embryo research is understandable, it is not the only area of science in which societies differ in values and laws. Scientists throughout the world work under different regulatory regimes governing human subjects, nonhuman animals, pathogens and biohazards, genetic modification of organisms and plants, and access to medical and public health records. In some cases, these differences reflect disagreements about ethically permissible conduct that approach the intensity of debates about the moral status of the embryo. More

Clashing perspectives on the ethics of the donation of human eggs for research purposes are likely to complicate international collaboration — whether stem-cell researchers like it or not.What price a human egg? The question provokes a variety of emotions and responses. Some will argue that an egg has no monetary value when it is just one of those ovulated each month by billions of women and that perishes unfertilized. Others might contend that the same egg is priceless — because it could, if introduced to the correct sperm, form the seed of a new person. Others still will find it morally problematic even to pose the question, on the grounds that it treats human cells as merchandise. More