Friday, February 09, 2007

Text of Fogel Statement

Here is the text of the statement by Susan Berke Fogel, coordinator of the Pro-Choice Alliance for Responsible Research, on the IOM report on the risks of egg donations. Fogel's statement could not be found elsewhere on the Internet at the time of this posting.

"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, and as a reviewer of the report, I believe it 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 meaningful informed 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.

"The Pro-Choice Alliance for Responsible Research 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."
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