Women's Eggs for Research: Without Payment?
Editor's Note: This article is an updated translation of one published in Gen-ethischer Informationsdienst. It is based on research conducted by Susanne Schultz for the EU-funded project REMEDiE (Regenerative Medicine in Europe), coordinated by the University of York. See Notes for further details.
Another earlier version was criticized by the companies the article discusses. For details, see Biopolitical Times' earlier discussion, Bending the Rules in California.
Should women be paid to provide their eggs for cloning-based stem cell research? Political discussion of that controversial prospect has stalled, in large part because researchers have not succeeded in producing stem cell lines with cloning techniques. But some companies continue these efforts. Others are producing stem cells using the technique known as parthenogenesis, which also requires women’s eggs. And in spite of international attention to iPS cells, new proposals to acquire the coveted resource are emerging.
In June 2009, the Empire State Stem Cell Board caused a stir. This agency, which is in charge of allotting public funds for stem cell research in the state of New York, decided to permit paying up to $10,000 dollars per cycle for egg retrieval for research purposes. Its decision is best understood in light of the difficulty that stem cell scientists have had in finding women to provide eggs without payment. In general, women are not willing to be subjected to this rigorous and risky procedure without remuneration just for the sake of science.1
Yet New York’s new commercialization policy contradicts regulatory standards in many other countries, and even in the US. For example, the taxpayer-funded multibillion dollar California Stem Cell Initiative passed in 2004 explicitly ruled out allowing researchers it funds to pay for oocytes. A separate California law passed in 2006 prohibits payment for eggs used in research that is not financed by the stem cell agency. 2
It is still too early to analyze how researchers in New York will proceed. However, my research in California during a trip in summer 2009 on behalf of the EU project REMEDiE and further communication with researchers show that despite that state’s rules, California researchers are already acquiring or making plans to acquire eggs using models that involve indirect payments. They are developing two different strategies that arguably undermine public policy in the state.
Research Cloning + Reproduction: A “Seamless Integration”
One method that is already being used relies on the integration of personnel, facilities, and financial incentives in the fertility industry and in research endeavours. A clear example can be seen in the Southern California seaside town of La Jolla, close to San Diego. An office building there simultaneously accommodates the fertility clinic Reproductive Sciences Center, the surrogacy and egg donation agency Select Surrogate, and the biotech company Stemagen. 3 This constitutes a three-fold union of staff and companies: Reproductive endocrinologist Samuel Wood, founder and medical director of both the fertility centre and the egg donation agency, is also Stemagen’s CEO. Stemagen is one of the few companies to have had any success in cloning research. In early 2008, Wood and his research team announced in the journal Stem Cells that they had successfully produced at least one cloned embryo, which developed into a blastocyst, the stage at which stem cell lines can be derived. The derivation step, however, failed (French u.a. 2008).
Wood explains that a “seamless integration between the fertility centre and the stem cell laboratory” was crucial for this success (Wood 2009). “We know we need to get the eggs immediately – we have to start the procedure within two hours after the eggs are retrieved,” he said. The “seamless integration” both permits this rapid timeline and facilitates the claim, found in the research report on the Stemagen website, that “the oocytes used…were donated, without compensation, by egg donors and intended parents undergoing egg donation cycles for reproductive purposes.”
Is this statement accurate? Wood explains that oocytes used by Stemagen for cloning research come from women under 25 years old who are paid $5,000 to $10,000 per egg extraction. These women are recruited by Select Surrogate to sell their eggs to clients waiting in the IVF units that belong to Reproductive Sciences Center. Payments for eggs for reproductive purposes is legal in the US, and common practice in California, despite concerns that young women are agreeing for financial reasons to undergo the onerous and risky hormonal treatments required for egg retrieval.4
But the La Jolla group of companies – fertility center, egg brokerage, and biotech firm – adds a twist. It asks women to agree that if more than 12 eggs are extracted, they will donate some of them, without additional payment, to research. 5 As the Center for Genetics and Society has previously suggested, this arrangement poses a possible conflict of interest. Concerns about that prospect have been strengthened by our investigation of the Stemagen model.
In fact, the same personnel carrying out the cloning research also supervise the hormonal treatment and other procedures that are part of egg extraction. Select Surrogate even advertises in the search for egg donors that “your fertility treatment will be performed by the noted reproductive endocrinologist, Dr. Samuel Wood.” Wood’s triple role raises the prospect that the safety and health of women providing eggs may not be the paramount concern in this process. After all, the number of eggs retrieved must be sufficient not only to satisfy the demands of the paying customers in the fertility clinic (itself a potential conflict of interest), but also to provide the researchers with as many eggs as possible. Administering larger amounts of ovarian-stimulating hormones will produce larger numbers of eggs – but also increase the risk of ovarian hyper-stimulation syndrome (see footnote 1).
Reproductive outsourcing and “egg sharing”
Eggs are also needed for another kind of stem cell research called parthenogenesis, which, like cloning research, is currently conducted by only a few companies. International Stem Cell Corporation (ISCO) is a Southern California-based biotech company that has developed at least four human parthenogenic stem cells lines, with which a number of stem cell projects currently are doing research (Janus 2009). The objective is to create a stem cell bank of parthenogenic lines with a large variety of immunotypes (ISCO 2010).
The eggs for the first lines were obtained from female IVF patients in a Moscow clinic (Revazova et al. 2008). However, in January 2010, ISCO announced in a press release the procurement of oocytes within the US, in cooperation with two California reproductive clinics: “California Center for Reproductive Medicine and Acacio Fertility Center provide a US source of oocytes under full regulatory and medical oversight that allow for the creation of the first clinical grade hpSClines anywhere in the world.” (ISCO 2010)
ISCO developed its egg procurement strategy in cooperation with an egg broker agency called Stem Cell Options. This agency, which is currently being established, is planning to procure oocytes specifically for research and arranged with ISCO to contact potential egg donors and Californian reproductive clinics interested in cooperation. 6
Unlike Stemagen’s “seamless integration,” the model of cooperation between ISCO and Stem Cell Options relies on a commercial relationship between a biotech company and an egg broker. In essence, it is a commercial outsourcing of access to oocytes. Stem Cell Options president Teri Royal explained in an interview that she agreed with vice-president of ISCO Jeffrey Janus that Stem Cell Options will receive a commission of $3,500 for each successfully brokered egg retrieval. Royal previously managed an egg broker company for reproductive purposes for many years. Following a scandal in 2003, in which eggs she brokered were repeatedly misappropriated by fertility clinics, she dissolved her old company (Sforza 2007).
According to Royal, ISCO plans two models of egg procurement. On the one hand she will use her old contacts to locate "dedicated” women who agree to donate for free. In addition to this model of altruistic donation, Royal explained, ISCO will also access oocytes by paying for part of the patients’ IVF treatments if they make some of their eggs available to the biotech company: "Jeffrey Janus pays the clinic and IVF physician directly for the IVF and lab services they provide. Presumably, the clinic will then reduce, in kind, the cost of such services charged to the 'sharing’ patient." (Royal 2009)
Internationally this strategy of reducing IVF-treatment costs in exchange for oocytes is called “egg sharing. In February 2010, Janus confirmed that this was one way in which his company would acquire eggs: “We are very confident that we can find appropriate donors under the programs available to us. One program remains the egg sharing program as I described to you earlier. Another program may be altruistic donors – where the donor donates all oocytes from one cycle towards establishing this stem cell bank.” (Janus 2010)
To date, there is no evidence that ISCO has started to retrieve eggs using “egg sharing” as a procurement strategy. The company emphasizes in its communications that it wants to comply with all legal and ethical requirements in California. However, in California “egg sharing” is violating at least the spirit of California laws that prohibit payment for eggs for research. Reducing medical services costs in exchange for eggs is payment, albeit not in cash.
Is ISCO interpreting the law differently? Janus did not agree to give another interview to clarify this question. An opportunity to hear more about this would have been in his invited remarks to a meeting of the California Institute for Regenerative Medicine (CIRM) in San Francisco in June, titled "Procurement of human oocytes in California and Russia, five years of experience of ISCO." 7 However, public access to this meeting was difficult. Two academics and women's health advocates reported that when they attempted to attend the meeting at the designated time, they were told that the meeting had occurred earlier in the day and that the meeting currently under way was closed to them, calling into question CIRM’s adherence to the state’s legal requirements regarding open meetings. 8 It will require further public observation to evaluate whether ISCO will put its plans into practice.
Conclusion: Setting Precedents
My investigation revealed that researchers in California are taking innovative approaches to introducing the dimension of payment into egg procurement strategies, thereby undermining the spirit if not the letter of state law. One approach already being implemented is the “seamless integration” of a fertility clinic and biotech company and the use of oocytes for which payments have been made for reproductive purposes. Another approach, still apparently in the planning phase, involves the commercial outsourcing of egg brokerage and “egg sharing.” This is taking place as the new policy in New York legitimates such endeavours on the national and international scale. In fact, Stemagen’s Samuel Wood has already announced that his company is opening a laboratory in New York and will apply for research grants there.
Susanne Schultz is editor of the Gen-ethical Information Service (GID) and supervises the project on Human Genetics and Medicine of the Berlin-based NGO Gen-ethics Network. She is currently doing research for the EU-funded project REMEDiE (Regenerative Medicine in Europe), coordinated by the University of York.
This text is an updated translation of Susanne Schultz (2010): “Ohne Bezahlung? Eizellen für die Forschung“ in Gen-ethischer Informationsdienst, 198, Berlin 2010, pp. 33-35
1In addition to the usual risks of an operation while under general anaesthesia, the best known risk of egg extraction is ovarian hyperstimulation syndrome, which occurs, according to the World Health Organisation, in 1 to 2 percent of women following hormonal stimulation. Symptoms include marked abdominal bloating or distention, shortness of breath, a changed blood composition, and increased vascular permeability. Possible consequences include renal failure, pulmonary embolism, and apoplexia. There have been isolated cases of death. Studies have shown that young women are at a greater risk than older ones (cf. Schindele 2007; Lippmann/Beason 2006).
2In both cases, only the reimbursement of documented expenses is allowed.
4According to Wood, the third advantage of the “seamless integration” approach is that reproductive medicine provides him with a pre-selection of the best donors. He explained that he prefers for cloning research those women whose ooyctes have already proven to be especially successful in producing offspring in the fertility clinic (Wood 2009).
5Stemagen uses eggs of women under 25 years old for its cloning experiments (Wood 2009).
6This and further statements regarding the cooperation are to be found in Janus, 2009 and Royal 2009.
7See the meeting agenda at California Stem Cell Report, 5 July 2010: http://californiastemcellreport.blogspot.com/2010/07/agenda-from-incident-at-marriott.html
8See California Stem Cell Report, 18 June 2010: http://californiastemcellreport.blogspot.com/2010/06/stem-cell-agency-bars-public-from.html
Beeson, D. and A. Lippman (2006) "Egg harvesting for stem cell research: medical risks and ethical problems" in Reproductive BioMedicine Online 13, 1-11
Byrne, J.A. et al. (2007): "Producing primate embryonic stem cells by somatic cell nuclear transfer," Nature 450, 497¬502
French, A. J., S. H. Wood et al. (2008): "Development of Human cloned Blastocyst Following Somatic Cell Nuclear Transfer (SCNT) with Adult Fibroblasts" in Stem Cells, 26, pp. 485–493
ISCO (International Stem Cell Corporation) (2010): Press release 25 January 2010, online (accessed 26.01.10): www.internationalstemcell.com.
Janus, J. (2009): Author’s interview with Jeffrey Janus (ISCO), August 2009 in Oceanside.
Janus, J. (2010): Email communication of Jeffrey Janus (ISCO with the author, February 2010
Revazova E. S. , J. D. Janus et al. (2008): "HLA homozygous stem cell lines derived from human parthenogenetic blastocysts," Cloning & Stem Cells, 10 (1):11¬24.
Reynolds, J. (2008): "The New Push for Eggs for Stem Cell Research in California," 27.07.08, Biopolitical Times (accessed 21.01.10): www.biopoliticaltimes.org/article.php?id=4149
Royal, T. (2009): Author’s interviews and email correspondence with Teri Royal, Aug/Nov 2009.
Schindele, E. (2007): "Rohstoff für das Mutterglück," DIE ZEIT, 18.01.07
Sforza, T. (2007): "Thousands of human eggs may be missing. Bankrupt egg donor registry says fertility doctors may have transferred eggs without permission," The Orange County Register, 23.07.07
Wood, S. (2009): Author’s interview with Samuel Wood, August 2009 in La Jolla