Physician Says Nothing He’s Done Deserves This : UCI scandal: Fertility specialist Sergio Stone concedes some mistakes, but says none warrants the nightmare he is now living. ‘Why me?’ he asks.

Dr. Sergio Stone admits he has made mistakes.

The 53-year-old doctor, caught in the maelstrom of UC Irvine’s fertility scandal, said he didn’t know that university approval was required for research derived from old patient charts.

And he is quick to declare that he was wrong not to have sought approval for a comparison of two drugs that he did at UCI’s Center for Reproductive Health.

But he said none of those infractions warrant the nightmare he now lives. None, he insisted in an interview Friday, warrants a university lawsuit that accuses him of administering an illegal drug and altering and withholding patient records in an effort to hamper the university’s investigation.

“Why me?” said Stone, who has been placed on paid leave along with his two partners by the university where he has worked for 17 years. “What have I done? I feel what is happening is beyond my lack of approval for a [research] paper.”

The controversy that erupted nearly three weeks ago at the UC Irvine fertility clinic is rocking medical bioethics nationwide and has prompted criminal investigation by the Orange County district attorney’s office and review by the state Medical Board.

What remains for Stone is a nagging doubt that he will have any future at all in his chosen field.

“My life is gone,” said Stone, wan and 15 pounds lighter since he learned in January of the severity of the allegations against him.

When Stone’s son graduates from medical school at UCI next Saturday, Stone won’t have the honor of crossing the stage with the rest of the school’s faculty. His suspension will prevent that.

Also gone is his opportunity to drape the purple and gold robe over his son’s shoulders in a university ritual reserved for faculty whose offspring follow in their footsteps.

*

At home in Villa Park, Stone rarely sleeps these days, arguing his case frantically in his mind at night. And he and his wife of 29 years, Angelica, have canceled their yearly trip to Italy, where Angelica loves to paint.

“My life is at a standstill,” Stone said. A history buff who has tried to maintain his sense of humor despite the pressures, the doctor compares himself to Napoleon in his banishment to Elba.

In his first interview since the controversy erupted, Stone strongly denied Friday that he had anything to do with the lawsuit’s most scandalous charges, that the eggs or embryos of several patients were implanted in other patients without the donor’s consent. He said his practice is confined to preparing the patients before their eggs are extracted.

The in-vitro procedures, he said, were done by his two partners--Drs. Ricardo H. Asch and Jose P. Balmaceda--renowned specialists in their field. Yet they are all being painted with the same broad brush, accused in the university’s lawsuit as if they are an inseparable trio, he said.

University documents show that only Asch administered HMG Massone, a fertility drug that was not approved by the FDA, yet all three stand accused of doing so in the lawsuit, filed last month.

“How can I separate myself from allegations that do not involve me at all?” Stone asked. “If I don’t do in-vitro fertilization, if I do not run the laboratory, why am I involved? Why has the university refused to delineate individual responsibilities?”

A university spokeswoman said she could not address Stone’s complaints about his treatment and said the doctors, and others affected, must await the outcome of the investigation.

“All the facts are not in yet and until they are no final judgment can be made,” spokeswoman Fran Tardiff said. “Until then, this is an unfortunate situation for everyone involved. . . . This is a tragedy for a lot of people.”

*

Stone said the first hint of the storm that now encircles his clinic came last November after he returned to the university from a conference. The university had appointed a three-member clinical panel to look into allegations surrounding egg transfers.

“When I learned of this in November, 1994, I thought it was so outrageous that I personally dismissed it,” Stone said.

Then came a visit to the university in late January by investigators from the National Institutes of Health. The team met with the doctors and some staff members for about an hour and questioned the clinic’s research procedures.

Four days later, Stone received a letter from UCI’s Executive Vice Chancellor Sidney H. Golub, informing him for the first time that he was under serious scrutiny.

“It sounded like it was the end of the world,” he said.

It was only with the federal investigators’ visit that Stone said he learned he needed approval from a university panel for studies based on patient records, even years after they were treated.

“It was a big surprise,” he said.

Stone, however, does admit to one research infraction, conducting a comparison of two fertility drugs, both of them clinically tested and widely used.

Stone said he and his partners had been using an injectable drug, and wanted to try out a nasal spray that other studies had already indicated was equally effective. The study, published last year, has become a focal point of the university’s preliminary inquiry into research misconduct because the university’s Human Subjects Review Committee knew nothing about it.

Federal investigators also honed in on the paper, saying the doctors blurred the line between clinical treatment and research.

Stone said the doctors did not seek approval for the research because they viewed it as a treatment, not pure research, and did not think it required approval.

In the fast-changing field of assisted reproduction, he said, doctors are always learning new techniques and testing new against old as they treat patients. Stone said that because of the field’s cutting-edge nature, the distinction between a clinical treatment and a research project “is a very gray area.”

Others who have scrutinized Stone also say his research failings were not egregious.

In an April 24 letter to Golub, Dr. Edward J. Quilligan, the former dean of the medical school who has been involved in investigating the allegations and monitoring the doctors as a proctor, defended Stone.

Quilligan said that the doctors did violate the university’s requirement for getting approval for human research and sanctions against them were warranted. But he said dismissal was too severe; failure to get approval for research based on patient records is not uncommon among researchers, he added.

Quilligan also said that “at no time during the investigation was Sergio Stone either accused or considered . . . as someone who was involved with” the sale of illegal drugs or the potential abuse of donated eggs.

Stone says he suspects that the intensity surrounding the university’s treatment of the doctors must have at its source something other than what officials have publicly stated--something worth the $900,000 that officials this week acknowledged they paid to whistle-blowers. The settlements included a requirement that the whistle-blowers not discuss the fertility investigation.

“It’s horrendous. The university has no money to buy books. They raised the tuition of students. Why are they spending $900,000?” Stone said. “There is too much intensity for what it looks like on the surface. For what? If they are innocent and I am guilty, why should they pay? If it’s my fault, I should pay to keep them quiet.”

What angers Stone most is not the accusation that he committed wrongs, but the university’s refusal to show him evidence that backs those allegations. Administrators, up to the chancellor’s office, have refused to take his calls, he said.

“Show me one record I falsified, one letter I changed, one date of consultation I changed . . . and I will resign immediately in shame,” he said.

Stone came to UCI in 1978. He grew up in Chile, in a family of lawyers, with his father an appellate judge. He attended medical school in Santiago. He came to USC in 1969 on a Ford Foundation fellowship and later completed a residency at Louisiana State University.

Stone came to the United States with an aim of specializing in contraception, he said, believing “there are too many people in the world.” But the field did not present a scientific challenge and his career took an ironic turn--toward the science of making babies.

He arrived at UCI as a specialist in reproductive endocrinology, practicing laser and microsurgery such as tubal ligation reversals.

In 1986, he recruited Asch and Balmaceda from San Antonio, where the pair had gained international prominence by pioneering GIFT, a fertilization technique where the sperm and egg are inserted into the Fallopian tube to encourage conception.

The pair brought a missing component to Stone’s fertility practice--in-vitro fertilization expertise. The three formed a partnership in 1990, opening the Center for Reproductive Health (which closed Friday), forging a relationship with the university and building a busy and lucrative practice that fed UCI’s coffers.

The doctors saw 2,500 patients in five years, Stone said, and through all that, he insists he was never aware of any wrongdoing.

But beginning in February, Stone said, he willingly subjected himself to professional indignities in an effort to clear his name.

The university placed patient records at the center under lock and key, Stone said, and he was given only limited access. A nurse would retrieve the file, photocopy it to make sure he did not alter it, and then place it in his hands so he could answer his patients’ calls.

“I agreed to everything,” he said. “I said, ‘Come and look. I have nothing to hide.’ ”

On April 26, the university confiscated all patient files, returning half of them a week later, and giving the other half back just this week, he said. The university alleged in its lawsuit that it acted because witnesses had seen several people, including the center’s office manager, removing files from the facility.

Stone said the whole ordeal has depressed him enough that he plans to see a physician. But his colleagues and patients have given him support to help him through.

At a dinner last week of a professional medical society, which more than 50 doctors attended, Stone found himself warmly received--”as if it were a wedding,” he said. Stone said he was afraid to go, but what he found there touched him.

“I walked through a line like a reception,” he said. “They all hugged me.”

Friday, as he prepared to close his clinic and move it to Fountain Valley Regional Hospital and Medical Center, Stone spent the morning seeing patients.

Even though some have asked to see their records and Stone worries he won’t be able to attract any new patients, his current patients have shown their support. He has received letters of encouragement from Alaska and phone calls from Italy and Brazil.

“The office was full of flowers the other day, and homemade cookies,” Stone said. “That part has been rewarding, but I am afraid of the future.”

RECORDS TAKEN, RETURNED: UCI settlement made whistle-blower return clinic data. A24

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Profile:

Sergio Stone

Age: 53

Family: Wife, Angelica, and three grown children

Current status: On leave from UCI

Birthplace: Valparaiso, Chile

Education: University of Chile School of Medicine; Ford fellow in reproductive biology at the USC Medical Center; served internship and residency in obstetrics and gynecology at Louisiana State University Division Charity Hospital of Louisiana

Board certification: Obstetrics and gynecology, reproductive endocrinology

UCI annual salary: $78,369.65

Position: “How can I separate myself from allegations that do not involve me at all? If I don’t do in-vitro fertilization, if I do not run the laboratory, why am I involved? Why has the university refused to delineate individual responsibility?”

Source: Sergio Stone