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Thursday, Aug. 7, 2008 | In January, renowned scientists and researchers lauded the success of Stemagen Corp., a small biotechnology firm in La Jolla, when it became the first to document the successful cloning of human embryos by fusing donated egg cells with the DNA from the skin cells of an adult man.
The research is widely considered a major step toward creating embryonic stem cell lines from cloned human embryos. Those cells are capable of evolving into the more than 200 different cell types in the body and, in theory, could one day be used to replace cells that have been destroyed by diseases, such as Parkinson’s and Lou Gherig’s Disease.
The technique Stemagen used, known as therapeutic cloning, replaces the genetic material of the donor egg with the DNA from a regular adult cell. It is particularly promising, proponents say, because the human body isn’t likely to reject replacement cells that genetically match its own.
But six months after the company’s success, when the California Institute for Regenerative Medicine was handing out $23 million in research grants, Stemagen’s application was denied. Dr. Sam Wood, the company’s chief executive, said the main reason the agency cited for the denial was the lack of a guarantee that enough eggs would be available for the research.
In 2004, voters approved Proposition 71, which created the $3 billion regenerative medicine institute to regulate and fund stem cell research in the state. However, the voter-approved ballot measure explicitly bans compensating women for eggs donated for research, even though fertility clinics have been allowed to pay donors for eggs since the industry emerged about 30 years ago. Wood said the ban should be scrapped because it has created a research-egg shortage that has thwarted — or at least slowed — medical breakthroughs.
“I’m hoping there will be a rising up of public opinion here,” he said. “If there’s not a change, this research will move to New York,” where new guidelines for a $600 million stem cell research program may allow payment for eggs.
Supporters of the ban and agency regulators, however, say it is necessary to avoid the creation of a market for eggs that could induce women to take hefty health and emotional risks.
According to some studies, donors have an increased risk of ovarian cancer and complications, such as infection or bleeding, could reduce the chances of pregnancy. Also, serious complications can arise from the stimulation of the ovaries and in are cases, the condition can be fatal.
“You can’t offer a first-year college undergrad facing huge student loans $25,000 and expect her to really contemplate the risks,” said Mike Kalichman, the director of the Research Ethics Program at the University of California, San Diego. “And what will happen later if they have difficulty conceiving a child after they’ve donated their eggs to science instead of saving them for themselves?”
Kalichman, who didn’t offer a personal opinion on the egg payment controversy, said the ban boils down to the fear of coercion.
“The idea is that if a woman is paid enough, there’s a point at which she may not pay attention to the risks,” he said. “The consensus has pretty much been to err on the side of caution.”
Wood balked at that notion.
“I think it’s outrageous that anyone would tell a woman she can’t make her own decision,” he said.
Some backers of the ban, including the Center for Genetics and Society, an Oakland public policy group, say the egg-dependent research approach should maybe be abandoned in favor of a newer technique where scientists coax, or induce, adult stem cells to behave like embryonic ones, sidestepping the need for the use of eggs or embryos in research. But scientists are still struggling to overcome some serious challenges with the induced cells, including the risk of cancer triggered by viruses that are used in the coaxing process.
“Embryonic stem cell research is where we’ve made the most headway,” Kalichman said. “We shouldn’t just jump out on another limb without very good reason.”
The payment ban is limited to eggs being donated for research purposes and doesn’t apply to women who give eggs to fertility clinics. According to the American Society for Reproductive Medicine, fertility clinic donors usually earn between $5,000 and $10,000 per donation. If women elect to donate eggs to science, they are only allowed to be reimbursed for any expenses they incur during the procedure and lost wages.
Wood said between $3,000 and $5,000 would be reasonable compensation for a woman who opted to donate eggs for research because the donation process, identical to the one used in fertility treatments, is an arduous one.
Women receive a series of roughly 40 injections of fertility drugs to stimulate the ovaries to produce many eggs at one time. While using the drugs, frequent medical tests and ultrasounds are required, and removing the eggs from the ovaries involves a minor surgical procedure.
“I don’t see how they would expect any woman to do it without getting paid for it,” said Diana Batzofin, the administrator for La Jolla IVF, a fertility clinic.
Wood may have a key ally in his effort to abolish the payment ban. In February, Dr. Alan Trounson, the regenerative medicine agency’s president, told a committee that research into therapeutic cloning was lagging because of an egg shortage.
Still, any effort to change the egg donation policy would be difficult. The ban is written into the voter-approved ballot measure that created the state agency and a 2006 law passed in the state flatly bans researchers from paying for eggs. Stem cell specialists said the issue won’t likely get much attention in the national elections because the next president will first have to grapple with the question of whether to lift President George Bush’s order that limits federal research funding to a few pre-existing embryonic stem cell lines.