Unregulated Stem Cell Research May Put Women's Health At Risk

Pro-Choice Groups Will Raise Concerns about an Expanding Market for Women's Eggs at March 9 Senate-Assembly Committee Hearing

Who: The Pro-Choice Alliance for Responsible Research, Our Bodies Ourselves, the Center for Genetics and Society, and Suzanne Parisian, M.D., a former chief medical officer for the FDA, have joined together to call attention to the need to regulate the harvesting of women's eggs for stem cell research.

What/Where/When: Members of the pro-choice groups will testify about the need for regulation of egg extraction and other aspects of stem cell research at the hearing of the California Legislature's Implementation of Proposition 71 Oversight Committee, chaired by State Senator Deborah Ortiz, on Wednesday, March 9, 2005 from 1:30-5 pm, State Capitol, Room 4203, Sacramento, California.

"I strongly urge that sound ethical and medical practices are adopted regarding the manner in which eggs are extracted from healthy women for research purposes," said Suzanne Parisian, M.D., a former Chief Medical Officer of the U.S. Food and Drug Administration. "As a scientist, I understand why some have expressed enthusiasm for SCNT [somatic cell nuclear transfer; also referred to as embryo cloning, research cloning, or `therapeutic' cloning]. But as a physician, I cannot condone SCNT at the potential expense of a woman's health without giving her an opportunity for adequate informed consent and establishing a mechanism to ensure her safety."

Dr. Parisian is a board-certified pathologist as well as a researcher in genetics and developmental biology. She details her concerns in an open memo for scientists, physicians, legislators, press, and public health advocates who have an interest in SCNT research, available at http://www.genetics-and-society.org/resources/items/200502_letter_parisian.html .

Both the drugs used to "shut down" women's ovaries and those used to "hyperstimulate" the ovaries to produce multiple eggs are associated with serious adverse reactions, in some cases life-threatening. Deaths have been reported.

Concerns about the health risks of egg extraction are gaining new urgency because of the prospect of increased demand for women's eggs for SCNT research, state funding for which was authorized by Proposition 71. Women's health and rights leaders have long advocated that women have the right to make informed choices about procedures that will affect their bodies. Many question whether women can give truly informed consent to provide eggs when the risks have not been adequately studied.

"The long term risks of the hormonal drug treatments used for egg extraction have not been adequately studied," said Judy Norsigian, co-founder of the Pro-Choice Alliance for Responsible Research and executive director of Our Bodies Ourselves. "We should wait until the Centers for Disease Control and others collect more complete data on risks for both these women and their offspring. We already do know about short term problems including ovarian hyperstimulation syndrome, which in relatively rare instances has caused severe problems, including death. Many of these drugs have never been approved by the FDA for the purposes of egg extraction."

Public policy organizations believe further study is warranted.

"If researchers begin experimenting with SCNT on a large scale, they will need eggs from many thousands of women. Payment to these women for their eggs, even if it is considered reimbursement, would create an economic inducement for women to put themselves at risk. This would be especially true for poor and young women," said Marcy Darnovsky, associate director of the Center for Genetics and Society.

"Unlike other types of medical research, where testing on human subjects occurs only much later in the process and after laboratory experiments have indicated that certain safety levels have been achieved, SCNT research requires that women be the first guinea pigs. Protecting women's long term health must be our highest priority," stated Susan Berke Fogel, co-founder of the Pro-Choice Alliance for Responsible Research.

At the March 9 hearing, the following recommendations will be made to the California state legislature:

1. California researchers should be required to adopt the safest and most ethical approaches to collecting eggs for SCNT or other research.
2. Extraction at the time of an ovariectomy or a tubal ligation would be far safer and more ethical than conventional multiple egg extraction procedures. Even single egg extraction with natural cycling (involving no hormonal manipulations of the ovary) would be safer than conventional methods.
3. Before undertaking multiple egg extraction from healthy women, all data on drugs used in such procedures should be reviewed by a neutral, knowledgeable, and independent oversight body whose sole purpose is to protect the safety and rights of women wishing to provide eggs. In order to accomplish this review, pharmaceutical firms must be required to disclose the FDA-approved indications and all available safety data on these drugs.
4. Before undertaking multiple egg extraction from healthy women, better quality data should be gathered that would make true informed consent possible for women considering providing eggs for research.
5. Every woman who provides eggs for research should have her own physician who is independent of the research and the research institution, and whose only job is to look out for the well-being of the woman.