Clinic Furor Seen as Threat to UCI Medical Research : Education: Fertility center allegations, if true, could imperil federal funding, some say. Others believe university’s quick response will limit damage and perhaps even enhance image.

Less than a year into her tenure as chancellor of UC Irvine, Laurel L. Wilkening expressed the fervent hope that Orange County’s leading institution of higher learning could become one of the top 50 research universities in the country by the year 2000.

But that was 1994, well before the startling revelations that Dr. Ricardo H. Asch and his partners at the university’s fertility center allegedly transplanted patients’ eggs without consent and conducted human subject research without permission. Well before the university sued Asch and two of his colleagues.

Now, the Center for Reproductive Health and even UC Irvine are under a cloud. Some fertility experts and medical ethicists said last week that the scandal may have a far-reaching impact, extending beyond the university to the research world as a whole.

However, the most devastating effect is likely to be at UC Irvine, where the university’s troubles have not only put the school under a microscope for possible research violations but also for possible crimes.

The Orange County district attorney has opened an investigation, as have the campus police and the Medical Board of California. Perhaps mindful of the pending litigation, few of the school’s administrators have even addressed the subject publicly.

But some acknowledge that, regardless of how it is perceived, the scandal poses serious problems in the short term and casts doubt over the school’s ability to fund and conduct research in the long term--and not just research limited to infertility.

“Fundamentally, all of the research depends on federal grants from either the [National Institutes of Health] or the National Science Foundation,” said Carl Cotman, director of the UC Irvine Brain Aging Institute, which has been hailed for its pioneering work on Alzheimer’s disease.

Indeed, the NIH views the unfolding developments at UC Irvine with “great concern,” Don Ralbovsky, a spokesman for the agency, said last week.

“I don’t want to prejudge the situation,” he said. “I can’t say UC Irvine’s funding is in any jeopardy. But our Office for the Protection of Research Risks is looking at the situation very carefully. It’s just not clear at this point if a violation occurred.”

All three doctors accused of transplanting human eggs without patient permission have denied any wrongdoing. Two of doctors filed court papers Friday contending that UCI officials trespassed at their clinic, lied about their employment status, harassed them and tried to destroy their careers.

If the allegations against Asch and his colleagues prove true, UC Irvine runs the risk of losing all its funding for medical research, according to Dr. Joseph Gambone, director of the fertility center at the UCLA School of Medicine.

“It doesn’t take much of an infringement for the [NIH] to just stop the funding--all of it,” Gambone said. “They’re pretty strict. If you don’t follow their regulations, they have a tendency to come down pretty hard.”

And without NIH funding, Gambone said, universities could scarcely function, at least in terms of research. He noted that UCLA receives “hundreds of millions of dollars” from the NIH, which has an annual budget in the tens of billions of dollars.

“What they end up doing generally is punishing the institution as a whole,” Gambone said. “They have a tendency to say, ‘You should have been more vigilant.’ ”

Ralbovsky said that, theoretically, Gambone is right: Although no NIH money went specifically to Asch’s center, it is the institution as a whole that agrees to meet “all federal guidelines” when obtaining government assistance.

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In the 1993-94 academic year, UC Irvine received about $38.6 million from the U.S. Department of Health and Human Services, and about 90% of that came from the NIH, according to Karen Newell Young, a university spokeswoman.

Young said about $11 million of the total amount was used for research “involving human subjects.” Gambone said any threat to such a large chunk of its funding could devastate a university, especially one with such ambitious plans.

Cotman, director of the Brain Aging Institute, guardedly agreed, using his own facility as an example.

Cotman’s institute receives more than $1 million a year in federal grants for research on more efficient ways to diagnose Alzheimer’s disease. He said the university is now rated among the top 12 in the country in neuroscience research.

But he said he expected that the swift action by Wilkening will have a lasting impact in terms of righting the university and ensuring that the fertility crisis reaches no farther than the doorstep of the Center for Reproductive Health. He cited the university’s opening its own investigation and filing a lawsuit against the doctors as examples of the fast action.

“What the chancellor did was act in a responsible fashion [to address the allegations],” Cotman said, “which I agree with.”

Others are not so charitable. Several bioethicists have criticized the university for delaying any action for months. The executive director of the Medical Board of California has said he would have been glad to use his office’s subpoena powers to help university officials obtain medical records crucial to their investigation, but the agency was never asked.

Wilkening remained silent last week as the university filed a lawsuit against three of its prominent researchers.

Other experts from around the country agreed that, in terms of preserving the university’s reputation and its dignity--and, most of all, its funding--the sort of response Cotman described is the only kind federal agencies will tolerate from an institution beset by scandal.

Robert Levine, a professor at the Yale University School of Medicine, said other schools--such as Harvard University and the University of Minnesota--have recovered from major research crises of their own.

To condemn a university such as UC Irvine because of the alleged misdeeds of a few “is like saying the United States is an evil society because somebody blew up a government building,” Levine said. “Like every other institution, there are some who don’t follow the rules.”

Nevertheless, the misdeeds of a few can have a domino effect on the university as a whole.

“When there’s a story that something went wrong at a university, it can be very demoralizing to the people within the institution,” Levine added. “What the effect will be in the long run is hard to predict.”

As chairman of Yale’s institutional review board overseeing human subjects, Levine said that once irregularities are reported, reviewers have the responsibility to talk to researchers to help them fix their faulty methods or, in extreme cases, to turn matters over to federal officials to eradicate the problem quickly.

Sidney H. Golub, UC Irvine’s executive vice chancellor, said the university’s image may actually end up benefiting because of the quick way it investigated allegations of research misconduct and took steps to prevent the same reported abuses or mistakes from being repeated.

At the same time, the state Medical Board has accused the university of reporting nothing until news of the scandal reached the press. Golub defended even that action, saying the school had hoped to remedy the problem in private, away from the glare of the media.

In the end, Golub said, “we will be known as a university that cares very deeply about having patients protected in our human subjects research, and that will attract faculty here that have those same ethical ideas.”

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Even so, the allegations against Asch pose a problem for the entire biomedical industry, in the view of Gladys White, director of the National Advisory Board on Ethics and Reproduction in Washington.

“Any time there is an absence of a meaningful process of maintaining and ensuring informed consent,” White said, “it has a chilling effect on all research efforts, because the public trust is lost. I’d have to say this is a very serious problem, not only for Dr. Asch and UC Irvine but for any researcher who needs to use that kind of human material. Only time will tell what the final impact will be.”