A number of concerned groups in California are encouraging citizens to urge Governor Jerry Brown to veto AB 926, which has passed both houses of the state legislature. AB 926 would repeal a provision in the California Health and Safety Code that prohibits compensating women who donate their oocytes (eggs) for research purposes. Wesley Smith has blogged against it, arguing that it would “permit Big Biotech to buy eggs from poor women to conduct human cloning and other experiments.” One Leah Campbell, a past egg donor and author of a book entitled Single Infertile Female and an eponymous blog and website, writes in the San Diego Union-Tribune that AB926 “aims to turn women’s bodies and ovaries into an assembly line.”
What is going on? It merits some unwinding.
In 2004, California passed Proposition 71, which established and provided $3 billion in bond funding for the California Institute for Regenerative Medicine (CIRM), to support basic and translational stem cell research. The proposition explicitly cited human embryonic stem cell research as a major priority. (In fairness, CIRM funds all things stem-cell, including somatic, or “adult,” stem cell research, and research with induced pluripotential cells [iPSC’s].)
As the California Senate’s analysis of the bill (available here) points out, at the request of the CIRM the Institute of Medicine (IOM) issued a 2007 report assessing the medical risks of oocyte donation for research. Those risks included ovarian hyperstimulation syndrome (OHSS) which can have serious medical consequences in 1-2 of every 1000 stimulation cycles; risks of the procedures involved; psychological risks; and unknown but potential increased risk of some cancers. The IOM pointed out that the stimulatory treatments needed for oocyte donation, when used in fertility treatments, are largely self-regulated by the medical specialty society involved, the American Society of Reproductive Medicine (ASRM), and the associated Society for Assisted Reproductive Technology. Further, there is no ongoing registry of oocyte donors in place to observe women systematically, over time, for medical outcomes. (This in the age of “evidence-based medicine.”)
Accordingly, in California law: “No human oocyte or embryo shall be acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies. For purposes of this section, ‘valuable consideration’ does not include reasonable payment for the removal, processing, disposal, preservation, quality control, and storage of oocytes or embryos” (Section 125350 of the California Health and Safety Code). AB 926 would not change that part of the law.
However, in accordance with the sorts of concerns identified by the IOM, California law has prohibited paying egg donors more than the actual direct costs of the procedures (the “removal, processing, etc.”). That is, women should not be charged for the medical and research procedures involved, but they shouldn’t be paid extra for their time and trouble, out of concern that such extra payment would constitute an unacceptable inducement to donate, and amount to impermissible exploitation. This is what Ms. Campbell (and Mr. Smith, and to be candid, I) am concerned about.
Now, AB would repeal this specific prohibition, and allow this extra compensation of women who donate their eggs for research. There are a couple of wrinkles:
First, as noted, the language prohibiting payment for the oocytes per se (or for an embryo) would not change, and new wording is provided to put a fine point on that.
Second, the bill tries to distinguish between donation specifically for research and donation for infertility treatment. How? To begin with, the rationale for the bill is that we already accept compensation for subjects of medical research, particularly for early clinical trials of experimental drugs given to healthy volunteers. Such compensation can reach well into four figures per study, leading the phenomenon of the “professional research subject” who serially volunteers for these studies and tries to make a living off the compensation for participating. Such compensation is for the subject’s time and inconvenience, and the consent form usually says so in so many words. This is standard practice in research ethics, and there is a substantial body of literature (and ongoing debate) around the merits or harms associated with this practice. The argument for AB 926 is that it would just treat women who donate their eggs for research like other research volunteers. Further, without the compensation, people won’t volunteer. (That is a safe assumption, based on the experience with drug studies in healthy volunteers.) And, since much of the research is sponsored by industry, Wesley Smith is, in a sense, correct: industry is not paying for the eggs proper, but they are paying for enhanced research participation. I leave it to you to judge whether this is a distinction without a difference.
How much compensation is too much? That is for Independent Review Boards (IRBs) to decide. AB 926 affirms that the IRB must make this judgment in the case of compensation for women who donate their eggs for research.
But what about women who donate eggs for infertility treatment? AB 926 tries not to be about them. But if there are “extra” eggs—eggs that an infertile woman deems, with her doctor, she doesn’t need for her attempts to have a baby—then, if the clinic harvesting the eggs belongs to the Society for Assisted Reproductive Technology, then the IRB “shall disregard” the matter of compensation.
Got that? The further wrinkle is that, according the California Senate’s analysis and the IOM report, while ASRM endorsed this sort of compensation for women who donate eggs for infertility treatment, it said that “total payments to donors in excess of $5000 require justification, and sums above $10,000 are not appropriate.” Yet it is common knowledge that these payments can be much greater than that. But in that case, AB 926 tells IRBs, “never you mind.”
Ms. Campbell (see the Union-Tribune link above) wrote that the aftermath of her egg donation included severe pain from endometriosis related to the ovarian stimulation, and, in a cruel irony, now she is herself infertile. Her story reminds one of “Eggsploitation.”
So what to say of all this?
- A decade after Prop 71, the commodification of the egg donation process, in the name of supporting research with created embryos, is a reality.
- If I were on an IRB evaluating a proposal, it would be a lively meeting:
- The egg donation is likely primae facie unethical because it supports the fundamentally unethical act to create or destroy human embryos solely for research purposes;
- Compensation to the donor would have to at least fall within the ASRM dollar limits as described above; higher amounts should be viewed as an unacceptable inducement;
- The required description of risks to the donor in the consent form must make the risks of severe complications of OHSS, and the lack of data on long-term risks, starkly evident;
- I would argue strenuously that two basic requirements of IRB approval of the research—that risks are minimized and that they are commensurate with the benefits of the research—could never be met.
This one had flown under my radar, and I now need to send a letter to the governor.