UC Irvine Cuts Ties to Embattled Fertility Clinic, Sues Directors

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 may have asked former patients to sign consent forms after research was completed. The university is seeking damages from the doctors, contending that they 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 UC Irvine Medical Center in Orange to Fountain Valley Regional Hospital early next month, but will remain on the university’s teaching staff.

During a hearing in Orange County Superior Court on Tuesday, the university requested a court order to prevent doctors from destroying evidence and removing computers that may contain important information. Judge Sheila B. Fell, however, denied the university’s request, saying there was insufficient evidence of any tampering 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,” UC Irvine 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 UC Irvine in 1986, Asch was considered a leading infertility specialist. 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 result in her Fallopian tubes.

The clinic moved to the UC Irvine Medical Center in 1990.

Asch declined to comment on the investigations.

The university began investigating the center in February, 1994, after learning that the center’s doctors had 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 did not think approval was necessary because the article was based on two earlier studies that had been approved.

The university said it has set up separate review panels to look into research, fiscal, clinical and management practices 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 that so far there is “no evidence that any patient has been placed at a health risk.”