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SEED OF DOUBT Would-be parents who trusted doctors now plan lawsuits

ORANGE, CALIF. — ORANGE, Calif. -- The babies born so easily to some people did not come to Annette and Bob Pfister. And like hundreds of other couples desperate to become parents, they made their way to the best fertility clinic with the finest doctors they could find -- the Center for Reproductive Health at the University of California, Irvine.

Now many of those patients, including the Pfisters, are planning lawsuits. Criminal investigations are under way as the university, the clinic and its doctors find themselves at the center of perhaps the biggest scandal ever in reproductive medicine.

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About 40 patients, the university acknowledges, probably were donors or recipients of eggs or embryos transferred without permission. Lawyers for former patients say that number could double.

Eight children may have been born as a result -- children whose biological histories may be unraveled only through DNA testing.

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And the problems, the university says, went further.

The Pfisters, still childless, were horrified to learn that embryos left from their attempt at in vitro fertilization were shipped off for // research -- to a Wisconsin zoologist.

"An endangered species," Mrs. Pfister said, "is more protected than my eggs or embryos."

Debbie and John Challender had a boy three years ago through in vitro fertilization, where the eggs and sperm are combined in a laboratory and transferred back to the woman. They were told in May that some of Mrs. Challender's eggs probably were transferred into another woman, who had twins.

"We started crying. We couldn't believe it," Mrs. Challender said.

Debra and Kent Beasley, parents of in vitro twins, had 11 embryos frozen in case they wanted another child. Now they say no one can tell them where those embryos are.

"Where did they go?" asked Walter Koontz, the Beasleys' lawyer. "Do they go in the trash can? Do they go down the sink? Do they go into someone else?"

Some UCI clinic patients say they never suspected any problems. Without warning, some were told it's possible they have a child they've never seen, a child born to and being raised by another family.

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They have a lot of questions.

If genetic parents decide they have some right to children born to others, can they sue for visitation? For custody? Can the birth parents block such attempts? What if the birth parents are poor? Abusive?

And consider the scores of embryos that wait frozen for possible future use.

What if the man and woman die, or divorce? What happens if they suffer dementia? And are embryos that haven't developed well and won't create a pregnancy proper subjects for research? Or should every embryo be treated, as the Pfisters believe, as "a possible child?"

Court rulings vary

Only a few court cases have explored these issues, and decisions vary from one state to the next.

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Ethicists say it's a wonder that reproductive medicine -- which operates with almost no federal regulation -- has flourished for so long without such a disaster.

"We're lucky we came this far," said medical ethicist Dr. Arthur Caplan, of the University of Pennsylvania Center for Bioethics. "I was just surprised it would come at such a leading facility with guys with such fine reputations."

The problem, he said, is society's refusal to confront the moral and ethical issues that envelop reproductive medicine. "People say this technology has gotten ahead of us, but it's been there for years.

"We just turned our eyes and didn't want to get involved," Dr. Caplan said. "There just hasn't been the political will."

The UCI clinic is closed now, shut down by the university in June. The doctors -- Ricardo Asch, Jose Balmaceda and Sergio Stone -- were put on leave, though they continue in private practice. The top executives of the UCI Medical Center, home to the clinic, were fired.

The university says the doctors operated unscrupulously. The doctors deny any wrongdoing. Lawyers for all three physicians maintain that this is all a terrible mix-up caused by incompetent university medical staff.

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"It is just a wholesale tragedy," said Dixon Arnett, head of the California Medical Board, which has the authority to revoke the doctors' licenses.

Former clinic employees say university officials were tipped three years ago to suspicions of egg-swapping at the Center for Reproductive Health but did nothing. The university maintains it had hard evidence only 18 months ago and quickly investigated.

"Hindsight makes things much clearer," said Dr. Sidney Golub, UCI executive vice chancellor. "This came to us piecemeal. We did not see this whole big picture that we see now."

"The patients trusted the physicians," said Fran Tardiff, a university spokeswoman. "The university trusted the physicians. And now it appears those physicians were not worthy of that trust."

'No better than Labradors'

In May, Debbie and John Challender got the first unsettling call from a UCI doctor, who left a message saying he wanted to talk for reasons he didn't specify.

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It was a newspaper reporter who gave them details -- medical records that indicated some of Mrs. Challender's eggs were used in another patient, who had twins.

"The doctors obviously feel we're no better than Labradors," Mr. Challender said sarcastically. "Why not breed them?"

The Challenders had been trying to conceive for 10 years and had adopted a boy, John Robert, before they visited Dr. Asch in 1991.

"The day he met me, he said, 'You will be pregnant,' " Mrs. Challender said.

To prepare her for in vitro fertilization, Mrs. Challender, a nurse, began taking hormones meant to force the ovaries to produce eggs. Lawyers for several patients allege that Dr. Asch routinely prescribed high doses of drugs, thus "hyper-stimulating" the ovaries in an effort to harvest many more eggs than needed.

Baltimore fertility doctors say they'd consider a procedure successful if the patient produced eight to 10 eggs. Mrs. Challender produced 46.

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She was too sick, however, to come back a few days later for the final step in the process -- the transfer of embryos into her body. Instead, Mrs. Challender was hospitalized for eight days to recover from the effect of the hormones.

While she was in the hospital, still unsure she'd ever get pregnant, Dr. Asch allegedly was using her eggs in the other patient.

It wasn't until November that she was strong enough for the embryo transfer. James Dominic, a winsome blond known as J. D., was born in August, two months after the twins.

"I didn't think [Dr. Asch] would be so despicable," Mr. Challender, 46, said.

The Challenders say the eggs were fertilized with Mr. Challender's sperm, and that they are the genetic parents of the 3-year-old girl and boy. They want visitation rights.

But lawyers for other patients say the situation is not that simple. They say they have medical records showing the twins' mother indeed received one of Mrs. Challender's eggs, along with eggs from another unwitting donor. All those eggs, according to those records, were fertilized with sperm from the recipient's husband.

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Only DNA tests would prove whether Mrs. Challender or the other donor is the genetic mother. The records, these lawyers say, do not support Mr. Challender's claim that he is the father.

The Challenders have told their story, they say, to pressure the government to regulate the fertility industry.

They've incurred some skepticism in Southern California, however, because their attorney, Theodore Wentworth, sent them to a media consultant. For $1,800, Mr. Wentworth said, the Challenders got a half-day's education in "how to talk in sound bites."

The Challenders said they saw no problem with a little coaching. "If we get out there and look like fools in front of the public," Mr. Challender said, "we'd be self-defeating."

Sterling reputations

The last place medical experts expected to see criminal investigations was in an office headed by Dr. Asch, Dr. Balmaceda and Dr. Stone.

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"Sterling reputations," said Dr. George Annas, professor of health law at the Boston University School of Medicine.

"They were the gurus. They were the guys," said Mr. Koontz, lawyer for the Beasleys. "People came from all over the world to see them."

The University of California, Irvine wooed Dr. Asch and Dr. Balmaceda in the 1980s, knowing it was courting the best. Dr. Stone was already on the UCI staff.

"Lawyers, people in the movie industry -- they all went there," said Melanie Blum, lawyer for the Pfisters as well as other patients and former clinic employees.

Dr. Stone, 53, came to the United States from his native Chile in 1969 and to UCI in 1978. He was head of the UCI Medical Center's infertility division in 1986 when he recruited Dr. Asch, 47, born in Argentina, and Dr. Balmaceda, 46, also from Chile. They had been practicing at the University of Texas in San Antonio.

The doctors' reputations were international. "These doctors made tremendous . . . contributions to our field," said Dr. Jairo Garcia, who heads the Greater Baltimore Medical Center fertility program. "Hundreds, thousands of people have benefited."

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Dr. Asch, who has published six books and more than 300 medical papers and articles, "is literally who's who in the world of fertility medicine," said his lawyer, Ronald Brower. "There's nobody as renowned as he is."

Fertility procedures are expensive, and not all insurance plans cover them. In vitro, for example, costs up to $10,000 each time it is tried.

But couples eager for children found ways to pay. "I have clients who have mortgaged their houses to the tune of $40,000," Ms. Blum said.

Arrogant and impatient

Annette and Bob Pfister, both 38, had been trying to have a baby for four years when they visited Dr. Asch in 1993. They found the center "very impressive." But they said Dr. Asch was arrogant and impatient.

"He never explains anything to you," Mrs. Pfister said. "They just slap down some papers and say, 'Here. Sign this.' "

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When artificial insemination failed, they tried in vitro fertilization.

Mrs. Pfister did not conceive. They said Dr. Asch suggested a microscopic inspection of the remaining embryos to see if doctors could glean information to help her become pregnant.

"We thought he was going to look at them, measure them, diagnose them and come back and tell us what was wrong," Mrs. Pfister said. She called repeatedly for results but was told there was no report yet.

Then they began reading newspaper stories about problems at UCI. She insisted the clinic tell her who was studying the embryos and got the name of a doctor at the University of Wisconsin. When she called there, the operator said, "Oh, the zoology department."

"I freaked out," Mrs. Pfister said. "I cried all day. What else did they take? Eggs? Embryos? Who has them? I'm not sure we'll ever know."

Employees take notice

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As hopeful patients continued to flock to the clinic, employees have testified that they began to notice irregularities.

An operating room nurse said he told university auditors in 1992 that he believed eggs had been taken from patients without permission and transferred to others. Other whistle blowers came forward in February and April 1994.

The university appointed a panel of medical investigators in September and received the report in March.

It found evidence that eggs had been transferred into patients without consent or knowledge of the donor. The investigators also said Dr. Asch imported and prescribed a fertility drug illegally. The University of California, San Diego recently reported it had uncovered problems with Dr. Asch's patients at a clinic there.

Financial auditors reported that the doctors under-reported clinic revenues, which reduced the amount they'd have to pay the university as part of their contract. The auditors also found Dr. Asch and Dr. Balmaceda filed false insurance claims.

In April, the university told the doctors it would close the clinic. But despite the findings of the medical and financial investigators, the university did not begin calling patients.

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"We wanted to do it promptly, but we wanted to do it right," Dr. Golub said. "We started organizing teams of support groups. We felt it should be done in a face-to-face encounter."

But the Orange County Register got hold of the documents and began making its own calls, getting to some patients ahead of the university.

Lost track of embryos

The Beasleys, according to their attorney, Mr. Koontz, are the parents of three, including twins conceived with the help of the UCI doctors in 1991. They elected to have 11 embryos frozen, in case they wanted to have another child. But with incomplete records, "we don't have any credible evidence that all of them are there," Mr. Koontz said.

"My clients have a firm belief in the potential for life in the embryos, and they'd like to have more children," he said.

They fear that their embryos were used to impregnate someone else. "If that is ever confirmed for them, would they want to interfere in that family's life?" Mr. Koontz asked. "They have to grapple with that."

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Clinic staff members have told Mrs. Beasley they cannot find her records, he said. The storage bank that has the embryos sent from the UCI clinic says it does not have the papers for a complete inventory.

Mr. Koontz said he has records that show not all the Beasleys' embryos were preserved.

Suits and criminal probes

As the lawsuits begin to be filed and the criminal probes go on, some lawyers say it's not even clear what legal principles apply.

Mr. Brower, Dr. Asch's attorney, said, "There's no legal precedent in the state of California to call eggs or embryos

'property.' "

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That means criminal theft laws don't apply. And if they are to be charged criminally, someone has to show that the doctors intended to commit a crime. He said no one so far has done that.

Lawyers for the plaintiffs say they can show the doctors' intent, and they expect criminal investigators will as well.

Could the scandal have been avoided? Perhaps through regulation, observers say. But Americans have been loath to debate the profound issues raised and to design appropriate strictures.

"We know how to regulate," said Dr. Annas of Boston University. "We've tried not to, because it involves reproduction. We usually like this to be an issue between the man and the woman. Now we've got the man, the woman and the doctor. Who else do you want involved? The government?

"On the other hand," he said, "this has now become an industry and we have to regulate it. There's no question about it."

Dr. Caplan of the University of Pennsylvania said the government must begin with some basic standards. He estimates 30,000 to 40,000 frozen embryos are preserved in the United States -- with only a few having any chance of being used.

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"The government does have a legitimate interest in protecting babies yet to be born," Dr. Caplan said. "It's way overdue for state legislators to take a look at these clinics and decide who can use these clinics and for what purposes."

And Dr. Caplan believes clinics should be subject to spot inspections of records, to be sure someone has an inventory of frozen embryos that are being cared for correctly.

"It takes a scandal before anyone takes this issue seriously," Dr. Annas said. "And this is a scandal."


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