In Quest for Miracles, Did Fertility Clinic Go Too Far? : Medicine: Bioethicists say pressure to succeed could have pushed famed UCI doctors to cut moral corners.

IRVINE — The couples came to Southern California from far-flung lands with purse-loads of cash, humble offerings to famed baby-maker Dr. Ricardo H. Asch.

In his packed UC Irvine fertility clinic, the desperation was palpable--even suffocating--as each quietly prayed that medical magic might give them what nature could not.

Asch was loath to disappoint them. After fertility treatments costing upward of $8,000, the Argentina-born doctor would lean low over his patients, touch them gently and murmur, “Dahling, I know you are pregnant.”

In seeking to fulfill that promise, Asch once said, a physician must resist the temptation to “play too close to God.”

But that, University of California officials charge, is exactly what Asch and his two globe-trotting partners failed to do.

In an extraordinary attack on three of its most prized medical superstars, the university has accused the fertility gurus of doing the unthinkable: stealing the eggs of some women and implanting them in others. In at least two cases, UCI alleges, women who received ill-gotten embryos gave birth.

The university’s May 25 legal complaint did not stop there. Its 29 pages heaped one shocking allegation upon another, from charges that the doctors had given patients an unapproved fertility drug to accusations that they had performed research on patients without their permission.

The doctors--Asch, Jose P. Balmaceda and Sergio Stone--insist they did nothing wrong. They contend that they are victims of vindictive university administrators, inept staff members and a mysterious blackmailer intent on destroying their careers unless they pay $100,000 apiece.

Suddenly, the baby-making business that promised such prestige and fortune to all involved has become a minefield of unimaginable moral and legal problems.

The controversy has done more than taint a few doctors and an institution. It has exposed an unsettling lack of regulation both in the fertility industry and at the academic centers where clinics often operate. UCI admitted to federal regulators that its system of monitoring human research suffered an “unacceptable” breakdown in the case of its fertility specialists.

A clinical panel of UC doctors investigating the clinic found “credible evidence” that two UCI patients’ eggs had been misappropriated--a finding one panelist described as “inexcusable . . . unconscionable.”

But in the quest to make babies, there are few rules. Dr. Arthur Caplan, director of biomedical ethics at the University of Pennsylvania, said there is “less regulation here than there would be in the animal-breeding industry.”

It is disturbing, ethicists say, that three of the fertility industry’s proudest pioneers--including Asch, who lectures widely on the ethical traps of his field--have triggered such painful self-examination.

“These people aren’t on the fringe,” Caplan said. “It’s not like this was done at a new clinic or a seat-of-the-pants operation. These people were pioneers. It’s certainly going to raise questions that will reverberate around the University of California system and throughout the nation.”

In the end, it may have been the pressure to succeed--both in the high-stakes fertility industry and in the hardball rivalry for academic prominence--that landed the doctors and the university on what one bioethicist labeled “the Titanic out on the bioethics ocean.”

So far, the university’s efforts to control the crisis seem only to have backfired. Last week, on the same day UCI’s top brass publicly denied that they had tried to hide the truth, they reluctantly confirmed that they paid three whistle-blowers about $900,000 as part of settlements requiring the employees to keep quiet about goings-on at the fertility clinic. They cited concerns about patient confidentiality.

For damage control, the school brought in a $300-an-hour public relations firm to salvage its soiled reputation--the same publicists Orange County hired in December to explain how one of the wealthiest counties in America had landed in Bankruptcy Court.

UCI’s Center for Reproductive Health was once the destination of the childless from throughout the world.

On most days the small, bland clinic, with which the university has severed ties, was crowded with the type of patients not used to failure: well-educated professionals certain that hard work and money produce results. They carried in bundles of cash or spread an array of credit cards on the counter to pay for a chance at fertility roulette.

By the time they landed in Asch’s waiting room, confidence usually had given way to despair. So they sat, sometimes for hours, waiting to see the jet-setting South American doctor whose Ferrari’s personalized plates read “DR. GIFT,” after a fertility procedure he invented.

“The only thing I can think of when I think of Dr. Asch is that he would try to do anything to take away the heartbreak of infertility,” said Ginger Canfield, 39, one of Asch’s earliest patients in Orange County. The Buena Park woman gave birth to a daughter seven years ago through in-vitro fertilization done by Asch.

In 1984, Asch, 47, and his partner Balmaceda, 46, hit the biomedical big-time by pioneering the technique called GIFT (for “gamete intra-Fallopian transfer”) at the University of Texas in San Antonio. In the procedure, a woman’s eggs and a man’s sperm are placed in the woman’s Fallopian tubes, where conception occurs naturally.

UC Irvine lured the pair west in 1986 and in 1990 gave them space in a new medical pavilion and provided all the staff. The pair formed a Dream Team-like partnership with Stone, a UCI veteran.

Asch, the clinic’s director, was a natural on center stage. Once in California, he parlayed his fame into the quintessential Southern California lifestyle: a million-dollar home in the gated Big Canyon community of Newport Beach, a $2-million Del Mar spread, a stable of racehorses and an entertainment company.

He was named in the “Best Doctors in America” books in 1993 and 1994, published six books, was honored by the university. He dropped in at clinics worldwide to display his medical wizardry, and an international clientele followed him back to his UCI clinic.

But the allegations brought the high-flying days to an end. In the third week of May, Asch and his partners were accused of leaping across ethical and legal lines.

The university severed ties with the clinic and sued to keep the doctors from destroying or altering patient records and embryologist reports.

One former patient accused Asch in court files of strong-arming her to sign a retroactive consent form that her eggs could be used for research. That woman, whose identity was not revealed, has filed a legal claim against the university indicating that she plans to sue Asch, alleging that he used eggs extracted during in-vitro fertilization procedures to make another woman pregnant. The woman’s attorney said he believes his client is the biological mother of a 1-year-old boy in Mexico.

Clinic doctors are also suspected of taking the eggs of one Orange County woman without her knowledge and giving them to another woman, who later gave birth to a son, university officials confirmed last week. In a third instance, a couple’s embryos may have been implanted in the womb of another woman, who later had twins, UCI officials said.

A whistle-blower alleged that doctors failed to report all the clinic’s income to the university and gave patients a fertility drug not approved by the Food and Drug Administration.

The doctors jumped to their own defense.

The week after the scandal erupted, Asch’s attorneys held a news conference to announce that the physicians had each received ungrammatical blackmail letters signed by “Dr. Malcolm X.” The letters said the writer had incriminating documents that would be released if the doctors did not each pay $100,000.

The fertility trio offered a range of explanations for what they consider a “witch hunt” against them.

Asch’s attorney, Ronald G. Brower, said that his client had fallen victim to either “deliberate or unintentional mistakes” by clinic staff.

“The doctor never sees any of the labels. He never sees the freezing log. He never sees the thawing log. . . . The doctor gets the catheter that’s got the embryos in it. That’s it,” he said.

Asch, Brower said, “has never knowingly or intentionally misused an embryo.”

Balmaceda acknowledged that he has made mistakes, but not the kind of devastating lapses in judgment and record-keeping of which he is accused.

Stone denied that he had anything to do with the most scandalous charges of egg stealing. He said his practice was confined to preparing patients before eggs and sperm were implanted and did not involve in-vitro procedures.

“How can I separate myself from allegations that do not involve me at all?” Stone asked, repeating a question he said he has pondered during many sleepless nights.

The district attorney, the Medical Board of California and the UCI police joined the state auditor in launching investigations. Committees in both the state Assembly and Senate are set to hold hearings as well.

But in a sign of how far lawbooks lag behind leapfrogging fertility technology, prosecutors are scratching their heads to find penal codes that apply to the allegations of egg wrangling.

The scandal has shoved hidden problems in the fertility industry, where some experts say that techniques are sometimes practiced before they are proven, into the national spotlight.

In the medical community, response to the allegations against one of their own was immediate--and troubled.

Fertility experts talked of the pressure to succeed pushing some doctors to cut moral corners, of the drive for winning percentages, of the tendency of patients to deify the doctors and of the doctors’ tendency to believe the hype.

Many of the doctors and medical ethicists interviewed in recent weeks said they were horrified by the allegations but not necessarily surprised.

“Things are done in this field that would never, ever be done in any other field of medicine without review or without big studies that look at efficacy or safety,” said Jonathan Von Blerkom, co-director of Reproductive Genetics In Vitro, a Denver clinic.

The reason? Money. Astonishing amounts of it.

At UCI’s Center for Reproductive Health, Asch and his associates reported earnings of $4.5 million from January, 1992, to August, 1994, according to UC Irvine’s College of Medicine.

Some doctors say the fertility industry will not be able to dodge this latest scandal.

“Undoubtedly, there will be and probably should be much stiffer regulations to come out of all this,” said Dr. Joseph Gambone, director of the fertility center at the UCLA School of Medicine.

Gambone said he had thought for years that too many centers--at least 30 in Southern California-- are doing such work. “And as a result, they’re far too difficult . . . to regulate,” he said.

The lack of industry oversight was compounded at the UCI clinic by the university’s admitted failure to properly monitor the center’s activities.

When it gets to the stage where there are egg-stealing allegations, “somebody’s asleep at the switch,” said USC bioethicist and law professor Michael H. Shapiro.

For the university, the scandal is the result of a dream gone unimaginably awry.

Less than a year ago, UCI Chancellor Laurel L. Wilkening announced with great fanfare her aspiration to vault the young university into the ranks of the nation’s top 50 research institutions by the year 2000. Health and biomedical science--which can attract millions of dollars in grants and contracts--were to be the cornerstone of that effort.

Instead, UC Irvine finds itself struggling to keep federal investigators from lopping off as much as $14 million in research funding. The U.S. Office of Protection From Research Risks has launched a full-scale investigation of the university’s human-subjects review process.

Some critics say the university is caught in a mess mostly of its own making. Bioethicists and others question whether efforts to keep big-name physicians and their well-heeled patients happy may have led UCI officials to turn a blind eye.

Stung by concerns expressed on and off campus that they were slow to act on early complaints, administrators went on the offensive last week, detailing their efforts to aggressively investigate every allegation.

At the same time, however, administrators conceded that they had agreed to pay hundreds of thousands of dollars in confidential settlements with three whistle-blowers.

Asch’s attorney, Brower, attacked the settlements as “hush money.”

Sidney H. Golub, the university’s executive vice chancellor, said adamantly, “We have overlooked nothing. We have hushed up nothing.”

But Golub acknowledged that the egg issue had come up long before. UCI auditors had looked into “vague, unsubstantiated” allegations of egg misuse as early as 1992 but were unable to dig up enough hard information to launch a formal inquiry until September, 1994.

At that time, an attorney for the three whistle-blowers handed the university a detailed account of alleged wrongdoing at the clinic, including egg stealing. UCI then appointed a clinical panel of three doctors to look into the charges, and their findings were devastating.

The panel found that Asch, Balmaceda and Stone committed a host of research and clinical violations, including conducting large-scale laboratory studies of patients without their consent.

Once federal investigators got wind of the research problems at the university, the National Institutes of Health threatened to pull funding for human research unless UCI made the necessary corrections. University officials have since scrambled to make reforms.

During a visit in January, federal officials found that the three fertility doctors failed to “recognize the serious nature of [the] alleged abridgment of human subjects’ research rights and welfare.” Investigators contended that the trio did not know the difference between standard medical practice and experimentation.

In the course of its written updates to NIH, the university made a stunning revelation for an institution that hopes to be the “research university for the 21st Century”--that its system of oversight had suffered an “unacceptable” breakdown in the case of the fertility center.

The findings of research misconduct blindsided UCI.

“Prior to the feds coming here, we had no reason to think there was anything wrong at all,” said Michael Brodsky, who chairs UCI’s Human Subjects Review Committee. “The research people [at the university] were totally unaware.”

It was a hard lesson, but Brodsky said UCI learned it well.

“We’re now realizing that we have to police the faculty or anyone who is going to put UCI’s name on a research paper,” he said. “I think people will realize that they’ve got to play by the rules and we’re going to be watching.”

Regardless of the outcome, the scandal is destined to be instructive for years to come.

“I can assure you that it’s part of the ethics course,” said Dr. Thomas Cesario, dean of the UCI College of Medicine.

Times staff writers Lee Romney and J.R. Moehringer contributed to this report.