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UC Irvine Cuts Ties to Acclaimed Fertility Clinic : Research: The university alleges that the campus facility did experiments without patients’ prior approval and intentionally destroyed evidence.

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SPECIAL TO THE TIMES

UC Irvine has terminated its relationship with an internationally acclaimed fertility clinic as federal and campus officials investigate allegations that doctors conducted various experiments without patients’ approval, university officials said Tuesday.

The university also filed suit against the three directors of UC Irvine’s Center for Reproductive Health, contending that at least one of them intentionally destroyed research evidence and might have asked former patients to sign consent forms after research was completed. The university is seeking damages from the doctors, contending that they also removed university medical equipment valued at $53,000.

The physicians named in the lawsuit--Ricardo Asch, Jose Balmaceda and Sergio Stone--will relocate their center from UCI Medical Center in Orange to Fountain Valley Regional Hospital and Medical Center early next month, but they will remain on the university’s teaching staff.

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During a hearing in Orange County Superior Court on Tuesday afternoon, the university requested a temporary restraining order to prevent the doctors from possibly destroying any evidence and removing computers that might contain important information. Judge Sheila B. Fell, however, denied the university’s request, saying there was insufficient evidence that the doctors had tampered with documents.

The university and the National Institutes of Health, which oversees and sets standards for human research, are conducting separate investigations of the fertility center. The university stands to lose $23 million in federal research grants if federal violations are uncovered, university officials said.

“The stakes are high,” UCI Chancellor Laurel L. Wilkening said in a prepared statement. “If the university does not conduct its research investigations properly or cooperate with the . . . inquiry, the National Institutes of Health could take actions that would threaten the university’s ability to conduct research, including the suspension of our federally funded research.”

Even before he was recruited to UCI in 1986, Asch was considered one of the country’s leading infertility specialists. In 1984, he gained international acclaim when he pioneered the GIFT procedure, which combines a woman’s eggs with sperm outside her body, and then places the mixture in her Fallopian tubes.

The clinic moved to the UCI Medical Center in 1990. Since then, Asch and his team have had 500 to 700 outpatient visits a year.

“He has a very good reputation and is a very competent individual,” said Dr. Joseph Gambone, director of UCLA’s fertility center. “Until specific charges come out, his reputation, as far as I am concerned, is still in very good standing. I would be very willing to send a patient to him.”

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Asch declined to comment.

The university began investigating the center in February, 1994, after learning that the center’s doctors published papers in medical journals without obtaining proper university approval, defense attorneys said.

Karen Taillon, Stone’s attorney, said her client acknowledged publishing an article without university approval of the research. But she said he thought approval wasn’t necessary because it was based on two prior studies that had been approved.

“He does not feel he’s done anything wrong,” Taillon said. “My client will not resign from the university. He’s going to continue to work as a faculty member and will continue to work in private practice.”

The university said it has set up five separate review panels to investigate research, fiscal, clinical and management practices at the fertility center. In January, federal officials began their own investigation of the human research being conducted at the center.

“The Department of Health and Human Services has a trust agreement with [UC Irvine] and any breach of that agreement related to protecting human subjects would be viewed with great seriousness,” said Gary B. Ellis of the National Institutes of Health.

After reviewing hundreds of documents and conducting dozens of interviews, Sidney H. Golub, UC Irvine’s executive vice chancellor, said so far there is “no evidence that any patient has been placed at a health risk. . . . We currently have no information that should cause people alarm.”

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But attorneys for the university said they still have not obtained the most important documents they believe would prove the doctors acted unethically: the clinic’s embryologist reports.

In April, the university sent security officers to the center and confiscated patient files and other records. However, they were unable to obtain any embryologist reports to indicate that the doctors might have collected eggs and sperm from patients without their prior consent, UCI attorney Robert Rotstein said.

Despite repeated requests for those reports, the doctors refused to hand them over, citing patient confidentiality policies, Rotstein said.

In court documents filed Tuesday, UCI lawyer Donald A. Goldman said that on Friday he was contacted by an attorney for a patient who had undergone an egg in-vitro procedure with Asch in 1993. The woman contends that last month Asch had asked her to sign a form saying she had consented to having some of her leftover eggs donated. Goldman said the woman had not consented and refused to sign any form.

Rotstein said the university decided to take legal action because it is in a partnership with the center, which means doctors must adhere to the policies of the University of California.

“The doctors are faculty members, and the employee manual indicates how their research will be reviewed by the university,” Rotstein said. “The university filed this suit to get to the truth. It believes the doctors are not cooperating and have not cooperated with our investigation.”

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Meanwhile, Asch’s attorney, David Brown, compared the university’s attempts to collect the doctors’ records to a “witch hunt.”

Brown said the center’s doctors do not have to hand over patient records because they run private practices and must adhere to patient confidentiality policies.

Dr. Michael Brodsky, who heads a committee overseeing UCI’s human research, said doctors at the fertility center failed to submit some of their research plans to the committee as required by federal regulations. But he said some of the omissions were “reasonable mistakes.”

“I tend to think these guys are being tortured for a whole collection of minor things,” Brodsky said, adding that “most of the university’s researchers do not think they committed any grievous sin.”

Brodsky said he believes that money is a more important issue to the university than concerns about research mistakes. He referred specifically to the financial arrangement between the university and the fertility center, which must pay a percentage of its earnings to support teaching.

“The big issue is the money issue,” Brodsky said.

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