New Stem Cell Research Woes

by Alan S. Miller

Marin County, California
April 17, 2006

So often in life, when we face important decisions and have to make choices on complicated issues, we discover the truth in the old saw that “the devil is in the details”.

That has been true for me as a long time supporter of basic stem cell research. I continue to be dismayed, for example, at the anti-science tilt—including opposition to most stem cell research—of the President and his ideological cronies.

But I am also concerned that the management program structured within the new California Stem Cell Initiative’s oversight apparatus provides inadequate protection to the women who will be the donors of the enormous number of eggs that will be needed for much of the research authorized under Proposition 71.

I fully support stem cell research that uses the leftover frozen embryos (now numbering in the tens of thousands) that rest in storage in fertility clinics all around the country.

Many people are opposed to using these surplus embryos (the unused remnants of in-vitro fertilization procedures) for any scientific purpose. But most of these frozen embryos not used in research will sooner or later be destroyed by the clinics. And it seems to me that a stronger moral case can be made for using this tissue than for discarding it as laboratory refuse.

The larger problem facing the scientific community and many thousands of women, however, is that huge numbers of human eggs will be required for the somatic cell nuclear transfer (SCNT) process favored by many researchers who hope to tailor make new cells for the needs of particular patients.

And part of that equation is that every egg donor will subject herself to a series of unknown medical risks.

The data on the dangers in this research are already coming in. Everyone has now read about the recent scandals in Korea where embryonic stem cell investigators faked their research and lied about the results of their work. And it was startling to discover that although more than 2000 human eggs were used in that now discredited research, the work failed to produce even one cloned embryo.

California medical sociologist Dianne Beeson predicts that “possibly millions of eggs may be required” to perfect the methods used in the SCNT process, the procedure of choice for many embryonic researchers.

Where will these eggs come from? In Korea, many donors were lied to about the end goals of the research in order to encourage their donations, some were paid for their eggs, and some lab employees were coerced into donating.

Here at home, most research teams plan to encourage women to freely donate their eggs. Hoping to contribute to the advance of reproductive system technology, many people will be eager to assist in this potentially promising form of scientific research.

But the hidden costs of egg donation have rarely been revealed to the public. Extraction of multiple eggs first includes “hyper-stimulation” using powerful hormones to manipulate the ovaries into producing a dozen or more eggs at a time. Removing the eggs requires a surgical procedure.

One drug commonly used to prepare for the egg extraction process is Lupron, a formulation never approved by the FDA for this purpose. The drug Antigon has now been given the federal okay, but no long-term studies of the health consequences of such hormonal stimulation have ever been conducted.

According to Dr. Beeson in her testimony at a March 7 Congressional Hearing, “The FDA currently has on file 6000 complaints regarding Lupron, including 25 reported deaths”. Studies also indicate that from 10-14% of women undergoing ovarian hyper-stimulation experience severe side-effects including abdominal discomfort, ovarian enlargement, nausea and vomiting.

35 women’s groups in Korea are now suing their government on behalf of women who have been harmed by these egg extraction procedures. Similar complaints have been lodged in several other countries. Concerns are also being raised by health scientists about the possible consequences of this hormonal stimulation for abnormalities in children later born to donor women.

Because universities and private researchers can now patent genetically engineered life forms, the field of embryonic stem cell research is provoking a biotechnological gold rush mentality. Too many people are prepared to profit from the egg donations of thoughtful and concerned donors.

Given the fact that California voters have now approved a three billion dollar stem cell program (the California Institute of Regenerative Medicine), political leaders need to provide for a more comprehensive regulatory process including full disclosure of laboratory protocols for both publicly and privately funded research.

This should include prohibitions on payments to egg providers (lest a market in human eggs be developed), a requirement that any egg extraction be carried out only by disinterested medical practitioners (not simply those directly involved in stem cell research), and follow-up medical care to treat any related health problems of women who have provided eggs to the researchers. A moratorium on SCNT research until more safety studies have been completed seems a sensible course of action.

Many of us voted for Proposition 71 because we did not know about the limited regulatory oversight written into the Stem Cell Initiative. Few of us understood the implications of the huge demand for egg donors implicit in the research proposals. And we did not know that the California Nurses Association and many other pro-choice and feminist health organizations opposed it.

It is time that we give some second thoughts to the long term implications of exotic research projects involving donated human eggs. Even if this work meets its final therapeutic goal of tailoring stem cells to remedy the diseases of particular individuals, only a very few people will ever be able to afford it. Many women will be put at risk as the demand for eggs increases.

And SCNT is one of the necessary first steps for those who wish to eventually undertake the cloning of embryos. We are not ready, either ethically or socially, to venture into that unknown scientific territory.

Once again, as is so often the case with the information made public about new scientific and technological procedures, the devil is still in the details.

Copyright © 2006 Alan S. Miller
Last updated: April 17, 2006