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The head of the internationally acclaimed UCI fertility clinic harvested eggs from an Orange County woman without her consent and gave them to another patient who delivered a baby boy about nine months later, according to medical records and interviews.
Photocopied records obtained by The Orange County Register track the 1991 harvesting of three eggs by Dr. Ricardo H. Asch, who designated they be implanted as embryos into a second patient at the University of California, Irvine, Center for Reproductive Health. "If those allegations hold up, they would be the most serious violation of ethical trust that I am aware of in the field of reproductive technology," said Dr. Arthur Caplan, director of biomedical ethics at the University of Pennsylvania. "There may be worse things that one could do in operating a fertility clinic, but I don't know what they are." Asch refused to comment Thursday when contacted at his Newport Beach home. His lawyer, David Brown, later said he could not comment before examining the patient's files. Asch has denied repeated requests for interviews this week. The center, where women from around the world have paid tens of thousands of dollars for the help of Asch and his team of specialists, is the focus of investigations by the university, state and federal authorities for alleged research misconduct by doctors there. But the allegation of misuse of eggs resulting in a live birth presents profound new legal and ethical implications, experts say. Photocopied records obtained by the Register show that three eggs were taken from the woman, a patient at the clinic in the early 1990s, and given to a second patient two days later. The records did not reflect whose sperm fertilized the eggs. Such sharing of eggs, which could lessen a woman's chances of becoming pregnant, requires informed consent and involves a series of other steps, including blood testing, fertility experts say. None of those requirements occurred, according to the woman, who learned Tuesday that she and her husband might be parents of a child they did not know existed. "The taking of the eggs and, possibly, the sperm of my husband was done without our consent or knowledge," the woman said in a written statement to the Register. She and her husband are professionals in their 30s and reside in Orange County. The Register is not publishing their names in an effort to protect the identity of the family. The Register has verified the birth through medical records and public documents. The couple, who are among hundreds of people treated at the center each year, said they learned of the alleged improper donation from an anonymous phone caller late Tuesday. "Since that time, we have had a number of conversations with numerous individuals and have learned that we were misled about the number of eggs that were removed from my body," the woman's statement read. University of California and UCI officials refused to discuss the allegations. "It is university policy not to comment on the content of a pending investigation," said Fran Tardiff, UCI spokeswoman. "I have no comment," said UC President Jack Peltason, who was chancellor at UCI when Asch and Dr. Jose P. Balmaceda established their practice there in 1990, along with Dr. Sergio C. Stone.
Records show that the woman's eggs were taken during a scheduled procedure known as GIFT, or gamete intrafallopian transfer - a fertilization technique invented by Asch and Balmaceda in San Antonio, Texas, in 1984. Biologist Teri Ord, who ran the lab at the center until leaving in September, said she did not remember the case. However, in all such cases, Ord said, she would methodically track and record the number of eggs taken from each patient. Every step of the procedure was recorded in a handwritten log. In all, 14 eggs were extracted from the patient, according to records of the procedure. Four of the eggs went back into the operating room, where the GIFT procedure was ready to begin, records show. Using a catheter, Asch inserted the four eggs, along with the patient's husband's sperm, back into her fallopian tubes in the hope they would meet there and form the beginnings of a child. But then the records show that three eggs from the patient were earmarked for another woman who was coming in two days later for an in-vitro fertilization procedure. Ord verified that she made the entry on the log, and said that she would have done so only on the order of the doctor doing the procedure. Records show that the doctor was Asch. As the patient lay in the recovery room, Asch came in and told her he had removed seven eggs, returning four to her fallopian tubes, the patient said Thursday. Asch then went into the hallway and told her husband the same news, the couple said. Later that day, all of the remaining eggs - including the three given to another patient - were fertilized, laboratory records show. Records do not indicate whose sperm was used to fertilize the eggs frozen on behalf of the patient, or for the woman who would later get her eggs. The patient said she was told the resulting embryos would be frozen in liquid nitrogen so they could keep trying to have a baby if the GIFT procedure was unsuccessful. Two days later, doctors inserted a catheter into the second woman's uterus and injected three microscopic embryos, lab records show. About nine months after that, a baby was born to the second woman. Records show the embryo implantation was performed by Asch's partner, Balmaceda, who directs the center's clinic at Saddleback Memorial Medical Center in Laguna Hills and who said he performs procedures at UCI when he is on call. Balmaceda said Thursday that he did not recall the patient's procedure, but said that he would not have known if consent was granted. "There is no way in hell the doctor who does the transfer knows what he's putting back unless somebody tells him," Balmaceda said. "This did not happen in Saddleback ever," he added. Patrick Moore, his attorney, said that the doctor would not check to see the source of the eggs unless he suspected an error had occurred. While the woman who received her eggs became pregnant, the patient whose eggs were taken had no such success. "My husband and I were unsuccessful in conceiving a child as a result of this procedure," her statement to the Register read. The couple subsequently did have children, after switching to another fertility doctor. At issue in the case is whether the patient consented to "donate" eggs. Fertility experts say it is extremely rare and highly unlikely that a woman trying to achieve pregnancy herself would agree to donate eggs to another. The patient said Thursday that she had consented to have four eggs implanted in her tubes and the remainder frozen in an embryonic state for future use. At no time was consent granted for donation, she and her husband said. Their contention was substantiated by a clinic employee, who saw the form on the day the eggs were gathered. "I'm positive that she marked freezing only," said Della Morrison, who started at the clinic in 1990 and left on maternity leave last year. "On the consent form, there's a list of options: cryopreserving, donation to another patient, research, and destruction. You can mark `yes' or `no' in a box next to each one. She marked just yes on freezing. She didn't mark the others." Shortly after the surgery, Morrison said, Asch asked for the patient's chart. Two days later, Morrison pulled the chart and looked at the consent form. "I was shocked," she said. "The box for donation had been marked. I was freaking out. I couldn't believe that happened." Morrison said it was clear to her that someone had altered the chart, but she did not know who. Others also would have had the opportunity to alter the form. About four days later, Morrison went to pull the chart to check again. "It was gone," she said. Because she does not have access to the laboratory and the records kept there, Morrison said she has no direct knowledge that the patient's eggs were given to someone else, or whether the patient later agreed to change her consent form. Only Asch and Ord, the biologist, would know for certain the source of eggs and embryos, she said. Ord, 39, who served as the clinic's lab director from 1990 until she quit last September, examined the Register's copies of the logs and said they appeared to be authentic. She said she could vouch only for the entries made in her handwriting and that she had no way of telling if other entries had been altered. Nor did she have any way of knowing, Ord said, whether patients had given consent to donate. "I just didn't see the charts," she said. "I don't see the consents. As far as whether it's true, not true, I don't know. I can just tell you from my end what went on in the lab." In examining the logs, Ord said, the entries tracking the eggs from the donor to the recipient reconciled. Three went from the former to the latter, Ord said. "I can tell you from the logs ... if that says that, that's what happened," she said. Asked if she had any doubt, she said: "No, none." Although internal audits in 1992 and 1993 revealed irregularities with cash controls and record keeping, the clinic came under heavier scrutiny beginning in February 1994 when auditors began looking into allegations involving "clinical, fiscal and management practice issues," the Register reported Tuesday. Later that day, University of California Regents sued Asch, Balmaceda and Stone, alleging among other things that records had been altered or removed in an effort to hinder the investigations. Legal papers filed with the suit allege that Asch used a Bakersfield woman's eggs for research without her permission in 1993 or 1994 - and then tried to alter records by asking her to sign a consent form just a week ago. The woman, who was not identified by name, was a former patient of Asch's. Investigators from the National Institutes of Health inspected the clinic's records early this year to check compliance with research protocols. When medical center administrators showed up at the clinic in January to examine records, receptionist Yvonne Alexander said, Asch spirited her into his office and handed her a piece of paper bearing about a dozen patients' names. The list included the name of the patient whose eggs were harvested in 1991, Alexander said. "He closed the door, and he was holding my hand," Alexander said. "He said, 'Don't tell anybody this.' He gave me a list of names, and I folded up and put it in my pocket. He gave me this list of names and asked me to find those charts before (the administrators) got to the charts." Alexander said she located only one chart, which was not the patient whose eggs were allegedly transferred without consent. She said she did not know why Asch wanted the charts. "I'm used to doing what he tells me to do," said Alexander, who is on leave pending a transfer to another university job. "When I pulled the one (chart), they were in the back. The phones were ringing, patients were signing in, and I was scared. I looked in the chart, and all I saw were the words `eggs transferred.' " Since 1992, clinic employees have been contacted, some on several occasions, by university investigators from the internal auditor's department. They questioned Morrison about a variety of things, including allegations that eggs and embryos have been taken from women without their consent and given to other women. Other employees told the Register they also had been questioned about eggs. Morrison said that the latest investigation has been going on for at least a year. Her last contact with a ranking official was about a month ago, shortly before UCI terminated its practice-management agreement with the clinic. The clinic is scheduled to close at the end of the month. The constant questioning of employees made life difficult at the center, she said. "It makes it real tough. It's real stressful. It's frustrating to work under those circumstances every day, to be questioned about your doctor and his ethics and what he does," Morrison said. Allegations of misuse of eggs pose a variety of ethical and legal questions. The Uniform Anatomical Gift Act says that body parts can't be taken from cadavers without consent from the people while they were living, or by their family members later. While the act doesn't address living tissue, including gametes and embryos, a 1990 California Supreme Court ruling held that it affects living donors as well, said John Robertson, professor of law at the University of Texas and co-author of the American Fertility Society's guide to fertility technology and the law. "They can't take it without your consent. If body parts have been removed, you have to inform them what they're doing" with them, Robertson said. Dr. David Olive, chief of reproductive endocrinology at Yale University, said it would be impossible to prevent such abuses, regardless of the law. "Anything can happen behind closed doors," Olive said. "That's why trust is so important." Register staff writers Michelle Nicolosi and Tony Saavedra contributed to this report. |