Report from the CIRM Standards Working Group meeting
When the Standards Working Group (SWG) of the California Institute for Regenerative Medicine (CIRM) met last week, the apparent purpose was to identify the emerging issues on which they were going to work. From all appearances, few working group members expected the bombshell from the new CIRM President, Alan Trounson, that he wanted to open the door to paying women for their eggs for CIRM-funded research, a clear end-run around California law.
The meeting agenda was vague enough for David Jensen of the California Stem Cell Report to call it a "mystery meeting." None of the meeting documents were posted on the CIRM website until I asked for them, and most were finally posted less than 24 hours before the meeting. Still, there was nothing to suggest that anything out of the ordinary was going to be discussed: a memo on pediatric bone marrow transplant clinical trials conducted by Dr. John Wagner; proposed changes to CIRM's Medical and Ethical Standard regulations that had been open to public comment; an item noted on the agenda as pertaining to iPS (Induced Pluripotent Stem cell research) was instead a paean to CIRM written by its biggest cheerleaders - CIRM board (ICOC) chair Bob Klein, new CIRM President Alan Trounson, and outgoing interim President Richard Murphy.
Alan Trounson stepped up to the podium, and certainly surprised nearly everyone in the room with a proposal that the SWG support paying women for their eggs by offering them compensation in the way of discounts on their fertility treatments - "egg-sharing" - if they agree to give up some of their eggs before they have achieved their own reproductive success. Never mind that Proposition 71 itself [PDF] prohibits compensation for egg providers in CIRM funded research; the CIRM regulations [PDF], adopted after a deliberative and public process, prohibit compensation; California statute passed and signed into law in 2006 (SB 1260) prohibits compensation in non-CIRM funded research, and the National Academies guidelines [PDF] prohibit compensation. The only permissible payment is for reimbursement of incurred expenses. Trounson made several assertions: (1) researchers cannot use spare embryos (this is incorrect - there is no California law that prevents people from donating embryos to research), (2) it is highly unlikely that women would give extra eggs when they go through fertility treatments (no evidence here), and (3) it is extremely difficult in California to get human eggs (others pointed out that there is no such evidence; however, SWG member Kevin Eggan stated that he hasn't been able to recruit egg donors in Massachusetts).
When ICOC and SWG member Jeff Sheehy raised the concern that such a situation known as "egg-sharing" could result in women being put at risk for Ovarian Hyperstimulation Syndrome (medical complications from the drugs given to women to induce their ovaries to produce multiple eggs) if fertility clinics induced them to over-produce eggs, Trounson countered by saying "Clinicians wouldn't do that." In stark contradiction, he later stated that reputable physicians would not counsel their fertility patients to donate eggs before they have achieved their own reproductive success, and that is why they have to pay women.
It soon became clear that at least one person in the room knew this was coming. Klein and Trounson had clearly been conspiring on turning California law on its head. Klein jumped in to make the argument that since it is permissible to reimburse women for medical care they might need for health consequences of providing eggs, he had a legal opinion from James Harrison, of the Remcho firm, with a twisted definition of "medical" to include IVF treatment, and arguing that paying women for a portion of their IVF would be "reimbursement" not "compensation." Alta Charo disputed that interpretation, saying that she believes allowing reimbursement for medical expense was intended to leave donors no better or worse off than they had been, and to give them discounted IVF would leave them better off, and not contemplated as a reimbursable expense. [As a sidebar, Mr. Harrison and his law firm, are paid hundreds of thousands of dollars per year to provide legal advice to CIRM. One has to wonder about the taxpayers paying for a legal opinion about how to subvert the law CIRM is supposed to uphold].
Sheehy added that the California voters who passed Proposition 71 thought there would be no compensation, and that he would not have voted for it otherwise. Klein then admitted that he wouldn't have voted for it either.
The larger question is why are Klein and Trounson pushing so hard for SCNT? Breakthroughs in iPS (induced Pluripotent Stem Cells) and other new avenues of research including those using embryos no longer needed for fertility purposes offers CIRM plenty of opportunity for leadership in research, without the health risks to women. As Kevin Eggan stated at the meeting, SCNT is still exciting, but it may become "increasingly passé."
Despite the concerns raised at the meeting, the bottom line is that the SWG agreed on 5 items for their future agenda, and 4 of them involve payment for eggs at some level of procurement.
They then tried to soft-pedal the decision by saying they were only gathering information.