Ever since she championed the nation's first state law to authorize embryonic stem cell research, Sen. Deborah Ortiz has been a heroine to patient advocates and researchers.
In the past week, though, some of their admiration has turned to shock and dismay as they learned the lawmaker wants to impose a three-year moratorium on multiple egg extractions for research.
The Sacramento Democrat said she is trying to protect women's health by temporarily barring the use of hormone treatments to increase egg production for research until more is known about the risks.
But researchers and patient advocacy groups said Ortiz's proposed legislation would create enormous obstacles to therapeutic cloning, one of the promising forms of research scientists want to fund with the state's new $3 billion stem cell research program.
"It will have a chilling effect and be very damaging for the research," said Larry Goldstein, a University of California, San Diego, stem cell researcher who's worked with Ortiz. "It interferes with a woman's right to choose whether she wishes to donate her eggs or not."
Janet Zucker, who has also worked with Ortiz to advance stem cell research, said she was "dismayed" and a "little speechless." She and her husband, Jerry, are two of the founders of CuresNow, a national advocacy group for therapeutic cloning, and she said they would help lead a coalition of patient groups in defeating Ortiz's legislation.
Ortiz said she was disappointed her allies had chosen to discuss their concerns in the media rather than with her.
"I am not abandoning them," she said. "I just care a lot about (the issue)."
Ortiz was a leading advocate for Proposition 71 - the stem cell research initiative voters approved in November - until the campaign ended. Then she began seeking changes in the law to strengthen its protections for public health and tax dollars.
She recently joined one of the initiative's foes, Sen. George Runner, R-Lancaster, to propose a constitutional amendment and legislation to overhaul Proposition 71. Ortiz said the senators proposed the three-year moratorium because of new information she received about the demand for human eggs.
During the campaign, the California Nurses Association and some women's health organizations opposed Proposition 71 because they said it would lead to "human egg farming." Ortiz debated these groups based on information she said she received from researchers that there would be no need to collect large numbers of eggs for the research.
Since the campaign ended, the senator said she has become concerned that the state-funded research will increase the demand for egg donations and lead to women risking their health.
"I just want to have a full discussion because we are changing from what we said during the campaign, and that troubles me," she said.
For nearly 40 years, millions of women have taken the drugs she's questioning to increase their egg production for fertility treatments. That would continue under the proposed legislation, and women would still be able to donate their eggs to others wishing to conceive a child.
But the legislation would block using the hormones for research, and scientists say that could impair their ability to conduct therapeutic cloning because hundreds of eggs are needed for the cloning in each case.
In therapeutic cloning, or somatic cell nuclear transfer, the nucleus is removed from an egg and replaced with the nucleus of a somatic cell derived from the skin or another part of the body.
The egg, with the somatic cell's genetic material, is then stimulated to begin dividing. When it reaches about 200 cells, stem cells - the master cells that can become any cell in the human body - are extracted for research.
Scientists hope to use this process to clone diseased cells so they can test drugs and examine the causes and progress of disease. Ultimately, they would like to avoid the need for anti-rejection drugs by creating transplants using a patient's own genetic material.
The science is still in its infancy and very inefficient, researchers say. In the first case of therapeutic cloning in 2004, a South Korean team used 242 eggs from 16 donors.
Researchers are studying other methods for therapeutic cloning that wouldn't require human egg donations. But they said they need human eggs now to develop these new methods.
Suzanne Parisian, a former Food and Drug Administration chief medical officer, told a Senate committee earlier this month that using drugs to increase egg production for the research could lead to strokes, cancer, cardiac problems and death.
Parisian and others said more research is needed to determine the level of risk so egg donors can make an informed choice about undergoing the drug treatments for research.
"It is not OK to use women as guinea pigs," said Marcy Darnovsky, associate director of the Center on Genetics and Society.
But she said the Ortiz-Runner legislation goes beyond opponents' recommendations for more medical advice and information for egg donors.
"We never mentioned a three-year moratorium," she said.
Ortiz said her legislation is based on Canadian regulations. Her proposal would allow egg donations - without the use of hormones - and the collection of excess eggs from fertility clinics and from surgical procedures, such as tubal ligations. Those methods could require moving eggs long distances from the clinics to the research labs.
Ann A. Kiessling, director of the only known American clinic collecting human eggs for stem cell research, said freezing these eggs and transporting them to the labs could result in as many as half the eggs being destroyed. As director of Massachusetts' Bedford Stem Cell Research Foundation, she said, she has avoided the immediate health risks to egg donors by eliminating the use of one of the most controversial drugs, Lupron.
She said she also administers the other hormones differently than in a fertility-clinic setting.
Even so, Kiessling said the long-term risks of these hormonal treatments may not be fully known for another 20 years.
"I don't think the work is going to wait 20 years, and I don't think people are going to wait that long to have kids," she said.
David Magnus, director of Stanford University's Center for Biomedical Ethics, said scientists know more about the risks of fertility drugs than most other drugs approved for clinical trials.
As is done in those trials, he said an independent review board - rather than the Legislature - should evaluate the risks, the proposed payments and the protections for egg donors.
"The Legislature doesn't know anything about scientific research or the practice of medicine," he said. "That is why they are not the ones to be passing laws on this."
Proposition 71 seeks to avoid exploitation of poor and vulnerable women by limiting payments for egg donations to the reimbursement for expenses. But it doesn't define what qualifies for reimbursement, and women have been paid as much as $50,000 to donate eggs to fertility clinics.
Joan Samuelson, a member of the stem cell oversight committee, said lawmakers should give the board time to develop standards to safeguard egg donors.
Ortiz said the oversight board hasn't shown much interest in this subject, so she introduced her bill. She said she's willing to compromise as long as women's health is protected.
But several of the patients who considered Ortiz their ally believe the moratorium could close the door on their chances for a cure.
"Three more years ... could be a matter of whether I make it out of this chair or not," said Karen Miner, a Davis mother of two who suffered a spinal cord injury in an automobile accident 12 years ago. "I don't understand this push to delay this for three more years when we have all fought so hard, and people are dying."
This site contains copyrighted material the use of which has not always
been specifically authorized by the copyright owner. We are making such
material available in our efforts to advance understanding of
biotechnology and public policy issues. We believe this constitutes a
'fair use' of any such copyrighted material as provided for in section
107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section
107, the material on this site is distributed without profit to those
who have expressed a prior interest in receiving the included
information for research and educational purposes. For more information
go to: http://www.copyright.gov/title17/92chap1.html#107. If you wish to use
copyrighted material from this site for purposes of your own that go
beyond 'fair use', you must obtain permission from the copyright owner.