Inquiries Target Fertility Clinic at UC Irvine

The Orange County district attorney’s office is trying to determine whether one of the nation’s foremost fertility experts broke any laws in the handling of human eggs at his multimillion-dollar UC Irvine clinic.

Investigators are particularly interested in whether Dr. Ricardo H. Asch, the founder of UC Irvine’s Center for Reproductive Health, may have misappropriated the eggs or embryos of one woman for implantation into another, perhaps for profit or benefit of some kind, a source close to the inquiry said Friday.

The case, which raises enormous--and in some aspects, never before explored--issues of medical ethics, bioengineering and reproductive rights, exploded this week with revelations that UC Irvine was severing ties to Asch’s clinic amid allegations that doctors there conducted unapproved medical experiments on patients.

On Tuesday, the UC Regents sued Asch, alleging that the doctor used the eggs of a patient for research without her permission, then attempted to alter the files by pressuring the woman to sign a consent form last week.

The lawsuit seeks damages from the doctors, contending that they also removed university medical equipment valued at $53,000.

An attorney for the regents said Friday that the medical files of five or six key patients from the center are missing, as well as embryology reports for a number of other patients.

“We have some suspicion that there might be the use of eggs without patient’s consent,” said attorney John F. Lundberg, who represents the regents, the governing board of the UC system.

University officials have been unable to determine whether any of the missing patient files might reveal possible improper or unethical practices because Asch and his partners, Drs. Jose P. Balmaceda and Sergio Stone have refused to turn over the records. Balmaceda and Stone also are named in the suit.

The university currently is conducting five separate investigations into the financial, clinical and research practices at the center, officials said.

Stone and Balmaceda said in written statements Friday that they were bound by patient confidentiality rules and have “cooperated with the UCI’s investigation to the extent [they were] legally allowed.”

The doctors said they had “not been informed of any allegation that [their] patients had received less than the highest quality of care.”

Asch could not be reached for comment Friday. His attorney, David Brown, said his client would have no comment during the investigations.

Dist. Atty. Michael R. Capizzi said his investigators would meet Monday with others from the UC Irvine Police Department and the Medical Board of California to “determine what action, if any, is appropriate.”

One aspect of the probe, however, is likely to focus on allegations by an Orange County woman that eggs harvested from her in 1991 were implanted without her consent in another woman, according to a source familiar with the inquiry.

The eggs were extracted during a process called GIFT, or gamete intrafallopian transfer, a procedure invented by Asch and Balmaceda in San Antonio in 1984.

Investigators also will be looking to see whether state records were falsified to hide the improper use of the eggs and whether medical procedures may have been improperly billed, the source said.

UC Irvine Police Chief Kathy Stanley said the team will look “into any possibilities of any type of criminal charges,” especially in relation to the possible improper transfer of eggs.

Questions about the center’s research practices first arose after the National Institutes of Health, which oversees research involving humans, launched an investigation of possible research misconduct at the center after a site visit in January.

The probes took a more aggressive tack Tuesday, when attorneys representing the UC Board of Regents alleged in court papers related to the suit that patient files and other medical records were removed from the center or altered to hinder their investigations.

“We do know that embryos were removed,” Donald A. Goldman, an attorney for the regents, said Friday. “We don’t what else was put in boxes and hauled away.”

Among the missing records are the medical files of a former patient of Asch’s at the center who learned last week that her eggs had been used for research in 1993 or 1994 without her permission, Goldman said in court papers. When the woman would not sign a retroactive consent form, Asch sent an associate to the woman’s house last week to get her signature, according to Goldman’s declaration in court records.

John Petrini, the woman’s Bakersfield attorney, said his client’s “private life was very important to her,” and she would not comment.

On Friday, the once bustling Center for Reproductive Health, a small office tucked in the Pavilion II complex of the medical center, was quiet and empty of clients. A receptionist there declined to answer any questions, saying only, “We are taking appointments, but have no clients today.”

The mushrooming allegations against Asch and his partners shook the medical and legal communities Friday, with some fertility specialists questioning an alleged breach of usually rigid protocols and ethical standards might occur.

Diane Smith, laboratory director at the Martin Luther Hospital fertility center in Anaheim, said there are strict protocols that clinics normally follow before using donor eggs in another woman.

“The donor has to know from the beginning that she is donating her eggs to someone else,” Smith said. “That’s how the process starts and that’s the guideline that we follow. I can only speak for what we do here.”

In addition, Smith said, patients at her clinic are told how many eggs were harvested from them, how many were fertilized, how many embryos were frozen and how many eggs were destroyed. She said the clinic’s records are monitored by the program’s medical director, who in turn reports to hospital officials.

“We’re required to keep detailed records, which are then reported to the American Society of Reproductive Medicine [in Alabama],” Smith said.

University officials acknowledged that their increasingly vigorous investigation of doctors at the center is spurred by the fear that the National Institutes of Health, which sets standards for human research, could punish the campus by withdrawing research funds.

Last year, UC Irvine received $14 million in federal funding for human research, which could be in jeopardy because of the current allegations, university officials said.

“We could not well afford that kind of loss,” said Sidney H. Golub, UC Irvine’s executive vice chancellor. “It depends on how we behave. If we had not cared if there were violations, if we did not want to better educate people about the issues, it [funding] would be at high risk.”

Golub said he expects that other educational institutions will be interested in the UC Irvine case. “They struggle with the same issues,” he said, but added that he has “never heard of any comparable situation.”

Times Staff writers H.G. Reza and Lily Dizon contributed to this report.