CONTENTS:

COMMENT -

Growing Need for Grassroots Awareness and Action

UPDATE -

The ProChoice Alliance for Responsible Research

NEWS -

Egg Donations to Be Banned

Human cloning ban easily passes House

Payment for Stem Cell Eggs Debated

Global Trade in Human Eggs Thriving

COMMENT:

International “Ethical” Guidelines for Stem Cell Research Points to Growing Need for Grassroots Awareness and Action: This month the International Society for Stem Cell Research (ISSCR) issued new guidelines on egg procurement and stem cell research that undermine existing sparse and fragile protections for potential egg donors throughout the world. These guidelines challenge the US National Academy of Sciences 2005 Guidelines that opposed payment beyond reimbursement of expenses to egg providers.

Like the NAS guidelines, the new ISSCR guidelines are not legally binding, but they are likely to be influential even though they reflect the perspective of those directly profiting professionally or financially from the development of stem cell research. The practice of scientists with financial conflicts of interest writing their own rules has become a major problem, particularly in the US. It is for this reason that the National Women’s Health Network recently called upon the National Institutes of Health to prohibit scientists with financial conflicts of interest from sitting on guideline-writing panels.

The ISSCR guidelines take an unusually liberal approach, not only by failing to oppose cash payments to procure eggs, but also by failing to impose restrictions on mating chimeras (animal-human hybrids) with non-chimeras, a practice the NAS guidelines oppose. Stem cell scientist and ISSCR guideline task force chair, George Daley, justifies these failures by arguing that political and cultural differences between countries are too great to make a blanket global statement. Such an approach facilitates the strategy of the biotech industry’s trade association, BIO, which proudly dedicates itself to helping biotech companies negotiate the international regulatory patchwork to find jurisdictions in which they can most easily acquire the raw materials and conduct the experiments they wish with minimum oversight.

Such developments make clear the need for women’s health advocates to redouble efforts to educate the public about the dangers of egg harvesting and the need for research in this area. TOP

UPDATE:

The ProChoice Alliance for Responsible Research: Cloning researchers have begun paying for studies of egg harvesting which, not surprisingly, minimize (whitewash) the hazards to women's health. The ProChoice Alliance for Responsible Research (PCARR) recently offered a rejoinder to one of these reports. PCARR is "a coalition of reproductive health and justice advocates, bio-ethicists, academics, and researchers working to ensure safety, accountability, and transparency in bio-technology from a women's rights perspective." PCARR urges that research endeavors should not require egg extraction procedures solely for research purposes, and clarifies that such research should better define the risks of multiple egg extraction, so that meaningful informed consent

PCARR STATEMENT:

"The Institute of Medicine has released a new report of its assessment of the health risks for women who may be asked to provide their eggs for embryonic stem cell research. The report documents how little scientific data exists about the health risks of egg retrieval, but misses an important opportunity to lead the way by requiring critically important safety evidence before we ask women to take potentially serious unknown risks with their health.

There are many paths of investigation in embryonic stem cell research that can move forward while this safety data are being gathered. Scientists can use embryos initially created for in vitro fertilization, but not ultimately used for this purpose and thus available to researchers with the donor’s consent. They can also use stem cells found in amniotic fluid. Even somatic cell nuclear transfer is possible using eggs that do not fertilize during in vitro fertilization.

Much attention has been given to the known risks of ovarian hyperstimulation that can result from drugs used to stimulate the ovaries to produce multiple eggs. But the risks of drugs used to suppress the ovaries before such controlled hyperstimulation have been much less studied, and the drug most commonly used for this purpose – leuprolide acetate (Lupron) – has never been approved by the FDA for this purpose. We know from the anecdotal reports of hundreds of women harmed by Lupron that such research is essential to establishing an adequate picture of the risks involved. Moreover, the recent drop in breast cancer rates and its link to a decline in hormone replacement therapy (HRT) is a timely reminder of how little is known about the long term effects of large doses of hormones.

The IOM report accurately states, “one of the most striking facts about in vitro fertilization is just how little is known with certainty about the long-term health outcomes for the women who undergo the procedure.” It goes on to acknowledge that even “that limited knowledge is not directly applicable to the safety of ooctye donation for research.” The report then rightfully suggests the need to collect good data, engage in long-term studies, and reduce risks to women.

Unfortunately, the IOM report elevates SCNT over other avenues of research in the development of future stem cell therapies. By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:

1. Research endeavors that do not require egg extraction procedures solely for research purposes; and

2. Research that will better define the risks of multiple egg extraction, so that meaningfulinformed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments.

Much scientific progress can be made by pursuing avenues of embryonic stem cell research that do not require women to sacrifice their health and well-being while important safety data are being gathered. The decision of whether to proceed with egg procurement for research should be based on adequate scientific evidence. It is premature to ask women to put their health on the line." TOP

RELATED REPORT: Case report and review of literature about arterial thrombosis in young women after ovarian stimulation, Visit Website

NEWS:

The HandsOff Newsletter features articles concerning policies, controversies, and ethics relevant to egg harvesting for research; this may include articles reporting medical information learned from the IVF industry. Similarly, articles concerning global egg trafficking in the IVF industry are relevant and may be included since the increased demand for eggs for research will likely build on these already ongoing global arrangements.

Egg Donation to be Banned: (from hankooki.com) The government is expected to ban human egg donations late this year, a move apparently motivated by the scandal involving the country’s disgraced cloning scientist Hwang Woo-suk.

A four-member subcommittee of the National Bioethics Committee is set to convene early next week to work out a draft prohibiting women from providing their eggs to researchers.

"We aim to finalize our stance on egg contribution at the meeting due on Feb. 6," said Prof. Cho Han-ik, who leads the committee, at Seoul National University.

"I think the subcommittee will come up with a draft outlawing egg donation for research purposes because a majority of committee members are against it," Cho said.

He said it remains controversial whether or not to allow females to offer surplus eggs for research, which are originally extracted for artificial insemination.

"The subcommittee will discuss surplus eggs. After reaching a conclusion, the overall bioethics committee will approve it late February or early March. Then the government will draw up a bill based on it," Cho said.

"We hope the government will send the bill to the Assembly for passage in May. If it gets the green light, egg donation will become illegal late this year," he said.

Currently, females can contribute their eggs for research although trading of the eggs is prohibited. A host of civic groups and ethicists have asked to outlaw egg donations.

They argue a substantial number of women who undergo ovarian stimulation to procure eggs suffer side effects including infertility in extreme cases.

They voiced such concerns in the wake of the scandal generated by Hwang Woo-suk, who claimed fraudulently to have established tailor-made stem cells with human eggs in 2005.

The cells proved to be hoaxes and this means that Hwang failed to extract a single tailored stem cell batch after using 2,221 eggs from 119 females.

However, the envisioned ban on egg contributions raises the ire of embryologists who want to research with eggs to produce the potential-lucrative embryonic stem cells.

"Should such a law be enacted, scientists will not conduct studies on embryonic stem cells in Korea. They may be forced to leave the country," Prof. Park Se-pill at Cheju National University said.

"Then, it would be a big loss. We need to took into accounts both national interests and ethics. But the ban on egg donation lacks balance. It’s overly tilted toward ethics," said Park, who harvested stem cells from human embryos in 2000 for the third time in history.

voc200@koreatimes.co.kr 01-31-2007 17:35 TOP

Human cloning ban easily passes House: HELENA - Human cloning would be illegal in Montana under a bill that won preliminary approval Monday in the House of Representatives. More TOP

Payment for Stem Cell Eggs Debated: Say you're a woman who wants to have fertility treatment but can't afford the $5,000 to $6,000 cost.

What if you could get it for half-price, by agreeing to donate half the eggs you produce for stem cell research? More TOP

Global Trade in Human Eggs Thriving: (AP) Chemotherapy beat back her ovarian cancer, but took Sophie Valot's fertility with it. Her doctor said she had just one option to start a family of her own: Find an egg donor, have children and get a hysterectomy _ in five years or less, or risk relapse. More TOP