NEW YORK (Associated Press) - Facing a human egg shortage they say is preventing medical breakthroughs, scientists and biotech entrepreneurs are pushing the country's top funders of stem cell research to rethink rules that prohibit paying women for eggs.
While fertility clinics have long paid for eggs, the voter-approved state ballot measure that created the $3 billion California Institute for Regenerative Medicine specifically bans compensating women for eggs donated for research.
Massachusetts, another center of U.S. stem cell research, also bans payments for eggs by law, and National Academy of Sciences guidelines advise against payments.
The restrictions are necessary, supporters say, to avoid creating a market for human eggs that encourages women to risk their health for speculative science.
But researchers argue that a shortage of eggs fueled by the payment ban is what's kept them from making the advances that prove their technique's real potential.
"You need to have enough eggs to make this thing work, and when you have enough eggs it does work," said Dr. Sam Wood, chief executive of La Jolla-based Stemagen Corp.
"If these guidelines weren't in place, we'd already have many (stem cell) lines and be much closer to a treatment for devastating illnesses for which these are so well suited," Wood said.
The conflict centers on an effort to create stem cells from embryos that are exact clones of adults. The hope is to one day use the cells them to generate transplant tissues or even whole body parts to treat incurable diseases.
The technique, known as therapeutic cloning, requires donated eggs whose genetic material is replaced by DNA from a regular adult cell such as a skin cell. Therapeutic cloning holds such promise, its backers say, because the body is unlikely to reject replacement parts that are an exact genetic match.
Last month, the California agency doled out $23 million in research grants but turned down all applications seeking funding for therapeutic cloning. Stemagen and at least one other biotech startup, Cascade Life Sciences Inc. of San Diego, were among the applicants whose proposals were denied.
A main reason cited for the refusals: no guarantee of enough eggs.
As the country's largest funder of stem cell research by far, California's policy sets the pace for biotech firms and academic researchers nationwide. National guidelines advising against egg payments were developed to ensure any innovations would remain eligible for California funds; any changes to the state's policy would likely have an immediate ripple effect.
California could also face increasing competition for business and scientific talent as New York prepares guidelines for its own $600 million stem cell research program. A draft report released by the New York program's planning committee said the state may allow payment for eggs.
Critics of the egg-dependent approach to stem cells say the promise of the research is outweighed by the potential harm to women, a view that has prevailed among regulators.
Even under normal doses, drugs used to coax eggs for use by fertilization clinics can occasionally lead to serious complications caused by excessive stimulation of the ovaries. In rare instances, the condition can be fatal.
Egg payments could also create a conflict of interest for those retrieving the eggs, according to therapeutic cloning skeptics. If money changed hands, they say, doctors responsible for the well-being of egg donors would also have a financial incentive to administer high doses of egg-stimulating drugs to produce as many eggs as possible.
The egg-payment issue is unlikely to gain much traction in national elections. The next president will face the more basic decision of whether to lift President Bush's order limiting federal funding to a few pre-existing embryonic stem cell lines.
Any effort by California regulators to revise the state's egg donation policy would also be difficult. The ban on payments for eggs using agency funds is written into the ballot measure voters approved in 2004, and a 2006 law passed by California legislators bans any researchers in the state from paying for eggs.
Still, the California agency's new president, Dr. Alan Trounson, caught the committee off-guard at a February meeting when he suggested that the egg-payment ban was hindering therapeutic cloning research.
At the same meeting, Harvard Stem Cell Institute researcher Kevin Eggan said that a $100,000 advertising campaign seeking charitable egg donations brought in just one egg. "We have literally pursued every option," Eggan said.
Last month, Trounson said research into therapeutic cloning was "floundering" because of access to too few eggs.
Ultimately, the resolution of the conflict in California and elsewhere could hinge on the success of another approach to stem cell research that requires no eggs at all.
In November, scientists showed they could reprogram human skin cells to behave like embryonic stem cells, cutting out the use of embryos altogether. Backers of the egg-payment ban say researchers complaining about the lack of eggs should focus their attention to the new technique, known as "induced pluripotent stem cells," or iPS.
"Do we really want to put women at risk to provide raw materials for research a lot of scientists say really isn't the way to go?" said Marcy Darnovsky of the Center for Genetics and Society, an Oakland public policy group.
Scientists are still working to overcome serious technical challenges with iPS cells, including the risk of cancer posed by viruses used to transform the skin cells into stem cells.
Whatever the obstacles, at least one multinational pharmaceutical company is betting stem cells could be the source of the next blockbuster medicine. GlaxoSmithKline PLC, the world's second-largest drug maker, announced a $25 million collaboration with Harvard stem cell researchers last week.
"Give us the eggs. If we don't succeed, then be critical," said Wood. "You have to give people the tools that are required to determine whether the methodology will work."
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