Stem cells: hope and fear | Judy Norsigian

In one niche, the risk to women is too great

By Judy Norsigian
November 14, 2010

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NOT ALL stem cell research is in women’s best interest.

The issue of embryonic stem cell research has long been clouded by certain activists — notably those from conservative Christian groups — who seek to stop all such research because it involves destruction of an embryo. In contrast, many pro-choice women’s health advocates like my own organization have long supported most embryonic stem cell research. But there is a small subset of this research we oppose — somatic cell nuclear transfer (SCNT, also called embryo cloning or research cloning) — because of substantial concerns about health risks for the women who provide the fresh eggs that this research demands.

As part of SCNT, the nucleus of an egg (from an egg donor) is removed, and the nucleus of an adult stem cell is inserted in its place. By contrast, conventional embryonic stem cell research utilizes otherwise discarded embryos from fertility clinics, and does not require freshly harvested eggs, where women undergo the risks of egg extraction solely for research purposes. This distinction is crucial.

Because thousands of women regularly undergo egg extraction procedures — either for themselves or for other women undergoing in-vitro fertilization — the public tends to assume that all the drugs routinely used for such procedures have been demonstrated to be reasonably safe. This is not true.

Extracting multiple eggs from a woman typically requires some suppression of her ovarian function. One drug used to do so — leuprolide acetate, which is sold as Lupron — has never been approved by the Food and Drug Administration for this purpose. Even two drugs approved by the FDA for such ovarian suppression — drugs sold as Antagon and Cetrotide — have inadequate long-term safety data.

Lupron, which does have several FDA-approved uses in both women and men, is marketed by TAP Pharmaceutical Inc., a company with a serious track record of fraud and inappropriate marketing of Lupron in violation of FDA rules. Through a group called the Lupron Victims Network, thousands of women have shared their problems with the drug. Many have also written to the FDA. Although the FDA has never systematically investigated the thousands of adverse reports, one FDA epidemiologist did conclude in March 1999 that there were “high prevalence rates’’ for serious side effects that warranted more study.

Until we have better safety data on these drugs used for egg extraction, it is not possible to obtain true informed consent from young women willing to provide eggs either for research or to help others have children.

Especially in the absence of long-term safety studies of drugs used in egg extraction, a national registry for problems encountered while using these drugs is an absolute must. There are precedents; a similar clearinghouse was created years ago to track the effects of anti-retroviral drugs used by pregnant women. A new registry could be funded by contributions from fertility clinics, which reap profits far greater than most other medical services (as chronicled by Debora Spar in her book “The Baby Business’’).

Much embryo stem cell research can nonetheless go forward utilizing embryos that were created for reproductive purposes. And if current progress in developing cellular reprogramming techniques continues to go well, it may ultimately not be necessary to utilize SCNT in developing new medical therapies.

The risk posed by drugs isn’t the only problem with this type of research. SCNT is the gateway to genetic modification of future children. As such, it requires special scrutiny by institutions concerned with the ethical conduct of research. Right now, many people enthusiastic about the idea of genetically altering their offspring to “select’’ for certain desirable traits fail to understand that the research path “from here to there’’ would be fraught with unethical clinical trials on women and babies. No matter how much animal research would be conducted beforehand, such experimentation with human beings would be largely unethical.

There is yet another reason to hold back on perfecting the technique of SCNT. This technology is key to human reproductive cloning, and until society thoroughly debates the wisdom of creating human clones, further development of SCNT should be halted.

For all the public discussion about the risk certain research poses to embryos, there has been far too little attention to the risks to adult women.

Judy Norsigian is executive director of Our Bodies Ourselves.