In Quest for Miracles, Did Fertility Clinic Go Too Far? : Medicine: Allegations of egg stealing at UC Irvine expose lack of regulations. Doctors deny wrongdoing.
The couples came to Southern California from far-flung lands with purseloads 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 encouragingly, “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 women and implanting them in others. In at least two cases, they say, women who received the 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 or inept staff members and a mysterious blackmailer intent on destroying their careers unless each pays $100,000.
Suddenly, the baby-making business that promised such prestige and fortune to all involved has become a minefield of unimaginable moral and legal problems.
There Are Few Rules in Baby-Making Field
The controversy has done more than taint a few doctors and an institution. It has exposed an unsettling lack of regulation in the fertility industry and at the academic centers where clinics often operate. UC Irvine 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 UC Irvine patients’ eggs had been misappropriated--a finding one panelist described as “inexcusable . . . unconscionable.”
But in the quest to make babies, there are few rules.
“There’s less regulation here than there would be in the animal-breeding industry,” said Dr. Arthur Caplan, director of biomedical ethics at the University of Pennsylvania. “It’s basically a market free-for-all with very little oversight over who offers services, what they do, how much they charge.”
It is perhaps telling, Caplan and other physicians say, that three of the fertility industry’s proudest pioneers--at least one of whom 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.”
So far, the university’s efforts to control the crisis only seem to backfire. Last week, on the same day UC Irvine’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.
For damage control, the school also 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 landed in bankruptcy court.
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Most days, the small, bland UC Irvine Center for Reproductive Health was crowded early with the type of patients not used to failure: professional, well-educated, 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, 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 Health Science Center 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 naturally occurs.
Stone, 53, a UC Irvine veteran, lured the pair west in 1986 and, in 1990, the university gave the trio space in a new medical pavilion, providing all the staff.
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, an entertainment company and racehorses.
He was included in the Best Doctors in America books in 1993 and 1994, and published six books. He dropped in at clinics worldwide to display his medical wizardry and an international clientele followed him back to his UC Irvine clinic.
Like Asch, Balmaceda and Stone got into the fertility field early and seemed to find the American dream.
Balmaceda, the son of a timber mill owner, left his native Chile for the United States in 1975. By the time he arrived at UC Irvine, he was a prominent fertility specialist.
Doctors Were Fertility Field’s Dream Team
Once in Irvine, his fame grew. He traveled to Italy and Spain to teach at universities. He enjoyed a good wine and made the rounds of the world’s top tennis tournaments, once sitting courtside in Andre Agassi’s box at Wimbledon, a former employee said.
Stone, like Balmaceda a native of Chile, grew up in a family of lawyers; his father was an appellate judge. He came to USC in 1969 on a prestigious Ford Foundation fellowship. When he arrived at UCI in 1978, he was an established specialist in reproductive endocrinology.
Almost immediately, the center was enormously successful and lucrative, at its peak handling 500 to 700 appointments a year. It brought in reported earnings of $4.5 million from January, 1992, to August, 1994. And it lined the university’s coffers as well, contributing about 10% of its earnings to UC Irvine and drawing patients to the financially hungry medical center.
The three were the fertility field’s version of the Dream Team--wealthy, well-respected winners.
Then came hints of trouble.
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After a holiday weekend theft of $4,600 from the center, an employee suspected of taking the money told university auditors in early 1992 that “there are problems with the eggs,” according to university officials.
The February, 1992, audit spotted serious failings in financial record-keeping and security. But university Executive Vice Chancellor Sidney H. Golub said auditors were unable to confirm the “vague, unsubstantiated” rumor about the eggs.
“They asked the doctors and they were told it wasn’t true,” Golub said about the auditors. An attorney for the university’s Board of Regents told the auditors to keep the “rumors” out of their report, Golub said.
An audit in 1993 found weaknesses in operating procedures and internal accounting and poor staff supervision. Auditors also found that documents and “some files were missing and employees were unable to locate” them.
Whistle-Blowers Step Forward
In February, 1994, the first whistle-blower stepped forward. She accused Asch of importing a fertility drug from Argentina not approved for use in the United States and giving it to patients. She also said that center doctors were keeping cash receipts that should have been reported to the university.
When university auditors investigated, they again heard rumblings of wrongdoing involving patients’ eggs.
Once more, Golub said, auditors found “no specific information that could be investigated.”
Still, the rumors would not die, and on July 18, 1994, a second whistle-blower complained. This time the warnings came from a much higher level: Debra Krahel, the senior associate director of ambulatory care at UC Irvine.
But Golub said Krahel’s letter alleging numerous problems at the center made only “vague” references to egg misuse and she did not appear to have firsthand knowledge. But a source close to Krahel told a reporter that Krahel gave the university detailed documentation about her claims.
Then, in September, 1994, university officials received a third complaint.
The letter, from an attorney representing the first two whistle-blowers, plus a third, showed officials how eggs were allegedly being stolen at the center and details of other wrongdoing, UC Irvine officials said.
Only then, Golub said, did UC Irvine have enough information to appoint a clinical panel of three UC doctors to investigate. Their findings were devastating.
“What happened is serious,” said Dr. Stanley Korenman of UCLA, one of the panel members. “It strikes at the heart of the doctor-patient relationship on several levels and could have a major nationwide impact.”
The panel reported in March that Asch, Balmaceda and Stone had committed a host of research and clinical violations, including conducting large-scale laboratory studies of patients without their consent.
In the meantime, someone called the National Institutes of Health and alerted federal investigators to alleged research misconduct by center doctors.
After a January visit to the campus, the NIH threatened to pull UC Irvine’s funding for human research unless the school rapidly revamped how it oversees human research. The university rushed to comply.
Shocked federal investigators said the three fertility doctors seemed not to recognize the seriousness of the concerns nor to understand the difference between standard medical practice and experimentation.
Faced with losing up to $14 million, university officials admitted that the system of oversight had suffered an “unacceptable” breakdown at the fertility center.
After launching multiple internal investigations, UCI officials made the controversy public May 15 by severing ties with the clinic, giving it three weeks to move. (The clinic has moved to Fountain Valley, but is not yet authorized to do in-vitro fertilizations there.)
The next day the university sued the three doctors and the clinic, seeking to block the doctors from destroying or altering patient records, and alleging that the physicians had stonewalled efforts to get at the truth.
The lawsuit also accused Asch of attempting to strong-arm a former patient the previous week into signing a retroactive consent form allowing eggs extracted from her in 1993 and 1994 to be used for research.
The woman, whose identity was not revealed, filed a legal claim last week against the university and the doctors alleging that Asch used her eggs to make another woman pregnant.
On May 19, Asch resigned from the UCI Medical Center and the university put all three doctors on leave from the faculty.
The following Thursday, the university issued a blistering amendment to its legal complaint, expanding the allegations to include egg stealing and drug misuse.
A UC regents attorney that day confirmed two cases of alleged egg misuse. The clinic trio is suspected of taking the eggs of an Orange County woman without her knowledge and giving them to another woman who gave birth to a son, he said.
In another case, the embryos from a different couple may have been implanted in the womb of another woman, who later had twins, the attorney said.
Several agencies, including the Orange County district attorney, the Medical Board of California and the UCI police, launched joint investigations. State auditors are at work as well. And committees in the state Assembly and Senate set hearings for the coming weeks.
Doctors Say They Are ‘Witch Hunt’ Victims
But in a sign of how far the lawbooks lag behind fertility technology, prosecutors are searching for penal codes that apply to the allegations of egg-wrangling.
The doctors and their attorneys said they were victims of a “witch hunt.”
Asch’s attorneys held a news conference to announce that the physicians had each received 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.
Asch’s criminal attorney, Ronald G. Brower, said his client had fallen victim to either the “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.
Many of the doctors and medical ethicists interviewed in recent weeks said they were horrified by the allegations, but not necessarily surprised.
They 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.
“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 the Reproductive Genetics In Vitro, a Denver clinic.
Dr. Joseph Gambone, director of the fertility center at the UCLA School of Medicine, said he has worried for years that too many centers--at least 30 in Southern California alone--are doing such work. “And as a result, they’re far too difficult . . . to regulate. Undoubtedly there will be and probably should be much stiffer regulations to come out of all this.”
For the university, the scandal has been a dream gone unimaginably awry.
Less than a year ago, 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 2000. Biomedical science was to be the cornerstone of that effort.
Instead, some critics say that the university is caught in a mess that is mostly 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 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, administrators conceded that they had agreed to pay hundreds of thousands of dollars in confidential settlements to the three whistle-blowers, but will not say why.
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 UC Irvine College of Medicine.
