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Bending the Rules in California

Posted by Jesse Reynolds on June 16th, 2010


Catalyzed by ongoing debates about paying women to provide eggs for cloning-based stem cell research (1, 2, 3),  Susanne Schultz, a German researcher and advocate, investigated two California organizations. Describing her findings (Update: now linked to cache version) at Bioethics Forum, an online project of the Hastings Center, she concluded they may be skirting the state's law prohibiting such payments.

Stemagen is a private biotechnology company and was the first lab to produce a human clonal embryo. At the time, we highlighted potential ethical and legal shortcomings in a press release and blog post. Schultz's essay provides further evidence for our view:

One arrangement relies on the integration of personnel, facilities, and financial incentives in the fertility industry and in research endeavours. In La Jolla, for example, a fertility clinic (Reproductive Sciences Center), a surrogacy egg donation agency (Select Surrogate) and a biotech company (Stemagen) operate in one office and share staff....

[The related companies] ask women to agree that if more than 12 eggs are extracted, they will donate some of them, without additional payment, to research. As the Center for Genetics and Society has suggested, this arrangement poses a possible conflict of interest, a concern strengthened by our investigation.

In fact, the same personnel carrying out the cloning research also supervise the hormonal treatments 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.
Schultz's second case is of Stem Cell Options, a private California company operated by Teri Royal, an egg broker. Royal's previous operation, Options National Fertility Registry, was one of the nation's largest but closed a couple years ago after a scandal in which thousands of eggs were possibly misused (1, 2). Now,
Royal is nevertheless using her old contacts to locate “dedicated” women who agree to donate for free. She told me in a phone interview last year that these are women who have experienced a disease in their family or among friends, and that this “moves them to want to do something to help speed up the process [of research].”

But Royal is not merely relying on her powers of persuasion to convince women to make “altruistic” donations for science. Instead, Stem Cell Options has arranged for its client, ISCO [International Stem Cell Corporation], to access oocytes from private fertility clinics in the vicinity of its research laboratories. According to Royal, ISCO pays for part of these patients’ IVF treatments if they make some of their eggs available to the company. Jeffrey Janus, vice president of ISCO, confirmed this model – internationally known as “egg sharing” – in an email message last February.

Both cases appear to violating the spirit, if not the letter, of California's law that prohibits payments for eggs for research.

Update (August 5, 2010)

One of the companies discussed by Susanne Schultz in her Bioethics Forum article, International Stem Cell Corporation, denies wrongdoing in their work with human egg. ISCO has acknowledged obtaining eggs from a Moscow fertility clinic for its research on parthenogenesis. But in a letter to the Hastings Center (publisher of Bioethics Forum), ISCO senior vice president Jeffrey Janus writes:

International Stem Cell has not obtained any human oocytes in California, or any other state for that matter….We outlined with [Ms. Schultz] various possibilities of obtaining oocytes to create our unique stem cells.”

Schultz explains that ISCO’s Janus and an egg broker working with the company independently told her in some detail about their plans to obtain eggs from Southern California fertility clinics. And a January 25, 2010 press release from the company says that it

announced today that it has signed up the first two in vitro fertilization (IVF) clinics and engaged an experienced pharmaceutical industry executive to lead the establishment of the company’s universal stem cell bank…. International Stem Cell Corporation has partnered with two IVF clinics in Southern California, California Center for Reproductive Medicine under the leadership of Dr. Lori Arnold and Acacio Fertility Center under the leadership of Dr. Brian Acacio.

If ISCO were to obtain eggs via these fertility clinics in exchange for discounts on patients’ treatments, it would be in violation of a California law that prohibits payment beyond reimbursement for expenses for eggs used in research.

Schultz says that she does not know whether any eggs have yet been procured under these arrangements, and that the implication that this has already happened is due to a translation or editing error.

The egg broker involved with ISCO, Teri Royal, posted a comment on June 21 (below) asking that our post be removed. ISCO’s letter “strongly requested” that Schultz’s essay be removed from Bioethics Forum (that has been done while the editors look into the situation), and the company’s public relations agency has emailed us multiple times with a similar request. We will retain the post, with this explanation. We welcome comments from all.

Previously on Biopolitical Times:





Posted in Assisted Reproduction, California, Egg Retrieval, Jesse Reynolds's Blog Posts, Research Cloning, Stem Cell Research


Comments

Comments are now closed for this item.

  1. Comment by Teri Royal, Jun 21st, 2010 4:07pm

    Dear Jesse,

    I was surprised to read your article this afternoon and find so many errors and misinformation contained in it, the most damaging of which falsely accuses Stem Cell Options and International Stem Cell Corporation (ISCO) of “skirting” California’s state laws that prohibit payment to women who donate their eggs to medical research.

    Although ISCO did request an introduction to a few local fertility clinics, the purpose was to evaluate the feasibility of working together with the clinic's physicians to stimulate and retrieve oocytes from a select group of volunteer donors who were recruited, screened and trained by Stem Cell Options’ specifically for ISCO’s research purposes.

    In no manner or form did I ever suggest, assist or participate in arranging for ISCO to bypass the donor recruitment services provided by Stem Cell Options and to access oocytes directly from the private fertility clinic’s own egg donors, nor do I have any knowledge that ISCO has actually done so.

    The proposal that ISCO “share” the eggs harvested from egg donors involved in pre-existing egg donation arrangements with their clinic’s own infertile couples came from San Diego fertility physician, Dr. Lori Arnold, and does indeed present a host of troubling conflicts that I strongly recommend avoiding. It is only one of several different egg donor recruitment ideas proposed to ISCO for consideration, and (to the best of my knowledge) it was not implemented.

    As is now clearly evident, there has been no violation of either the spirit, or the letter, of California’s laws by Stem Cell Options or ISCO. We, therefore, urgently request that an appropriate apology and prompt retraction of this erroneous (and damaging) misinformation be published immediately and in all versions of the next issue of BIOPOLITICAL TIMES (whether it be printed on paper, posted online, through associated blogs, columns, e-mails, feeds or other electronic news venues, or by any other manner or means within its power) to restore our good names and reputations within this noble field of science.

    Teri Royal
    President
    Stem Cell Options
    (Website under construction.)
    June 21, 2010


 


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