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Infertility and Assisted Reproduction

Emerging Biotechnologies: Cloning

Concerns about Lupron™ (leuprolide acetate), used in the process of extracting eggs from women (for IVF, research cloning, and potentially for inheritable human modifications)

by Judy Norsigian, Executive Director, OBOS
October 2002

There are substantial risks to women’s health posed by Lupron™ (leuprolide acetate), the most common drug used to hyper-stimulate the ovaries in the process of extracting eggs, now commonly done as part of IVF (in vitro fertilization) procedures. Such eggs are now only rarely used to produce clonal embryos (either for human cloning experiments now being conducted by a few irresponsible scientists or for human research cloning. In both instances, somatic cell nuclear transfer (SCNT) takes place, whereby the egg is enucleated and the nucleus of an adult cell is inserted to take the place of the original nucleus).

At this point, lack of good quality data makes true informed consent with Lupron impossible. However, there are many women who feel comfortable taking what might be substantial risks, because they are doing so in the interests of helping themselves or another woman become a parent who is genetically related to their offspring. In the case of research cloning, there are no likely near-term benefits and a fairly distant promise of therapies that may result from research with clonal embryos.

As of the spring of 1999, the FDA had received 4228 reports of adverse drug events from women using Lupron™. (Interestingly, they also received 2943 such reports from men, who used the drug in prostate cancer treatment, and despite the differences in age, sex, and indication for use, the complaints were remarkably similar.) 325 adverse events reported for women resulted in hospitalization, and additionally, 25 deaths were reported. Whether these deaths are directly attributable to Lupron remains to be determined, and the FDA has indicated that it does not have enough staff to follow up on this matter now. The BWHBC will be filing an FOIA (Freedom of Information Act) request to obtain both these reports and reports submitted since 1999 and hopes to work with public health experts to review them.

Numerous women have reported serious problems with persistent joint pain, headaches, fatigue and other difficulties even years after their last Lupron™ shot. There are also numerous reports in the medical literature.

Given our current problems with under-resourced and inadequate IRBs (Institutional Review Boards), we cannot now expect most IRBs to adequately protect the women who might provide eggs for research purposes.

Until such time when better and more reassuring data might become available - or different drugs developed with a better safety profile - it is unethical - on safety grounds alone - to move forward with somatic cell nuclear transfer. (There is a possibility that unused frozen eggs extracted initially for the purpose of IVF could be used subsequently for producing clonal embryos to be used in research - thus not requiring women to be exposed to Lupron's risks solely for the purposes of research - but there are still major problems with using frozen eggs.)

Just at the practical level, it makes little sense to pursue clone cures for the diseases most often mentioned in media reports. Parkinson's and Alzheimer's diseases alone affect 5 million Americans and would require minimally 250 million eggs to produce individualized therapies that would match the patient's own genome. (This figure of 250 million assumes that at least 50 eggs would be needed per patient.) And since about 10 viable eggs are likely to be collected, on average, from each individual woman who is a donor, 25 million women would be needed as donors - about half of all women of reproductive age. The specter of such massive use of ovarian hyper-stimulation coupled with laparascopic surgery makes no sense, especially when other fruitful and less problematic approaches to developing therapies are already underway.

Even Republican Senator Bill Frist had strong cautionary words about proceeding forward with more widespread use of Lupron. On the Senate floor he quoted from the November 25, 2001 issue of the St. Louis Post-Dispatch, an article entitled "Buying and Selling of Women's Eggs Raise Fears of Bidding Wars'':

"In California, the increasing demand [for eggs] has resulted in a flourishing egg-donation industry that can reward donors with payments equivalent to a semester's tuition at an Ivy League school. Greater demand also has increased prices on the East Coast by several thousand dollars."

Frist goes on to comment: "I mention that because clearly if there are individuals or companies out there with what inevitably will be a financial incentive to obtaining these eggs, the burden is very likely to fall upon women of low income. The eggs will have to be obtained through a medical procedure. The medical procedure has its own risks as well. There are no safeguards today for women who would be used as sources of the needed eggs. I believe that a failure to prohibit human cloning not only poses a real risk to the health and safety of the women but will have the effect of turning their bodies into commodities."

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