The Institute of Medicine has issued its report on last September's workshop, held at the request of the California stem cell agency to assess the medical risks of egg retrieval.
This report is a strange document. It recounts the testimony of workshop speakers, most of whom acknowledged just how little data has been collected and how few follow-up studies have been done on the health risks of super-charging women's ovaries and extracting their eggs. And then it reaches the conclusion that this is a "remarkably safe procedure."
One of the report's pre-release reviewers was Susan Berke Fogel, long-time advocate for women's health, reproductive rights, and health access. Fogel also coordinates the Pro-Choice Alliance for Responsible Research, a coalition of individuals "working to ensure safety, accountability, and transparency in bio-technology from a women's rights perspective." (Proud disclosure: I'm also a member.)
The Pro-Choice Alliance found the IOM report extremely disappointing, and released a press statement under the title Report on egg procurement reaches conclusions unsupported by its findings. Some key points:
The report documents how little scientific data exists about the health risks of egg retrieval, and as a reviewer of the report, I believe it misses an important opportunity to lead the way by requiring critically important safety evidence before we ask women to take potentially serious unknown risks with their health...
Unfortunately, the IOM report elevates [somatic cell nuclear transfer] over other avenues of research in the development of future stem cell therapies. By suggesting that researchers must have thousands of women's eggs now, despite the critical absence of safety data, the report does women a great disservice.
Read the full press statement by the Pro-Choice Alliance below.
February 9, 2007
Report on egg procurement reaches conclusions unsupported by its findings
Contact: Susan Berke Fogel 818.621.7358 (cell)
The Pro-Choice Alliance for Responsible Research released this statement in response to the release of the Institute of Medicine report on the health risks for women who provide eggs for research, “Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research.”
This statement can be attributed to Susan Berke Fogel, Coordinator.
The Institute of Medicine has released a new report of its assessment of the health risks for women who may be asked to provide their eggs for embryonic stem cell research. The report documents how little scientific data exists about the health risks of egg retrieval, and as a reviewer of the report, I believe it misses an important opportunity to lead the way by requiring critically important safety evidence before we ask women to take potentially serious unknown risks with their health.
There are many paths of investigation in embryonic stem cell research that can move forward while this safety data are being gathered. Scientists can use embryos initially created for in vitro fertilization, but not ultimately used for this purpose and thus available to researchers with the donor’s consent. They can also use stem cells found in amniotic fluid. Even somatic cell nuclear transfer is possible using eggs that do not fertilize during in vitro fertilization.
Much attention has been given to the known risks of ovarian hyperstimulation that can result from drugs used to stimulate the ovaries to produce multiple eggs. But the risks of drugs used to suppress the ovaries before such controlled hyperstimulation have been much less studied, and the drug most commonly used for this purpose – leuprolide acetate (Lupron) – has never been approved by the FDA for this purpose. We know from the anecdotal reports of hundreds of women harmed by Lupron that such research is essential to establishing an adequate picture of the risks involved. Moreover, the recent drop in breast cancer rates and its link to a decline in hormone replacement therapy (HRT) is a timely reminder of how little is known about the long term effects of large doses of hormones.
The IOM report accurately states, “one of the most striking facts about in vitro fertilization is just how little is known with certainty about the long-term health outcomes for the women who undergo the procedure.” It goes on to acknowledge that even “that limited knowledge is not directly applicable to the safety of ooctye donation for research.” The report then rightfully suggests the need to collect good data, engage in long-term studies, and reduce risks to women.
Unfortunately, the IOM report elevates SCNT over other avenues of research in the development of future stem cell therapies. By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:
1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments.
Much scientific progress can be made by pursuing avenues of embryonic stem cell research that do not require women to sacrifice their health and well-being while important safety data are being gathered. The decision of whether to proceed with egg procurement for research should be based on adequate scientific evidence. It is premature to ask women to put their health on the line.
The Pro-Choice Alliance for Responsible Research is a coalition of reproductive health and justice advocates, bio-ethicists, academics, and researchers working to ensure safety, accountability, and transparency in bio-technology from a women's rights perspective.
Sex selection is a hot topic. So when the American College of Obstetricians and Gynecologists states that it's unethical for doctors to participate in sex selection for "family balancing" or "personal preference" because doing so would support sexism, as it did in a February 1 statement, you'd expect a bit of media attention.
You wouldn't be wrong: The New York Times weighed in on February 6 with an article titled "Girl or Boy? As Fertility Technology Advances, So Does an Ethical Debate."
The eyebrow raiser is that the piece doesn't get around to mentioning ACOG's new statement until the eighth paragraph, and that all three of the sources it cites - two MDs who run fertility programs and a bioethicist known for his libertarian leanings - think sex selection is just fine.
Many of the shortcomings of California's stem cell research program can be traced to its enabling law, which is deeply flawed. Passed by the voters as Proposition 71, it contains numerous exceptions to the norms of oversight, accountability, and transparency. But according to Capitol Weekly, legislative reform of Prop 71 is planned for the third year in a row. But this time, a new chief proponent and the passage of a sunset date have changed the outlook for reform.
Sen. Sheila Kuehl will be spearheading an effort to amend them this year. In short, she and her Republican cosponsor, George Runner, plan to introduce two pieces of legislation. One would alter the composition of the agency's governing board, by including two representatives of public interest groups. The other would strengthen the state's claim on a share of financial returns from any profitable discoveries made with public funding. Both ideas are worthy of support, and the bills' language should be available within a couple weeks.
It's encouraging to see Kuehl, a progressive Democrat known for her sustained effort for universal health care, take on the mantle of reforming the California Institute for Regenerative Medicine. Former senator Deborah Ortiz, who was recently term-limited out, tried to repair Prop 71 in each of the last two years. But she ran up against the law's three year prohibition on legislative modifications and ruthless opposition from the CIRM's leadership. Now Kuehl, who inherited the chair of the Senate Health Committee from Ortiz, and George Runner, the cosponsor, need to get merely 70% of both houses and the governor's signature: quite a daunting task.
The new spokesman for the CIRM praised the Legislature's input, in general, but declined to comment on the proposals until the language has been released and reviewed. This is quite a contrast to the reaction to Ortiz's efforts, which ranged from "The Legislature is not needed" to calling Ortiz "an ongoing threat." The CIRM leadership should be judged by its actions, which we'll soon see, and not by its lofty rhetoric.