Investigator Says UCI Case Could Have Broad Bioethical Implications

As one of three physicians asked to investigate allegations of impropriety at the Center for Reproductive Health at UC Irvine, Dr. Stanley Korenman came away believing that a benchmark case was taking shape, one that might affect the future of in-vitro reproduction and even medicine itself.

“The fundamental nature of the relationship of doctors to patients is what’s in question here,” said Korenman, associate dean for ethics at the UCLA School of Medicine. “What happened is serious--in some respects, very serious. It strikes at the heart of the doctor-patient relationship on several levels and could have a major, nationwide impact.”

Korenman and his panel colleagues--Dr. Mary C. Martin of UC San Francisco and Dr. Maureen Bocian of UC Irvine--found “credible evidence” that a misappropriation of donor eggs had occurred in at least two cases involving UC Irvine patients from whom consent was never obtained.

Although no patients died or were subject to physical harm, Korenman labeled the lack of consent involving eggs “utterly inexcusable . . . unconscionable.”

Martin could not be reached for comment, and Bocian declined a request for an interview.

The doctors who ran the Center for Reproductive Health--Ricardo H. Asch, Jose P. Balmaceda and Sergio Stone--have denied any wrongdoing and are vigorously contesting the recent lawsuit brought by the university.

But in findings released by UC Irvine on Thursday, the medical panel also concluded that the center’s trio of doctors committed a litany of research as well as clinical violations. The panel found that the doctors took eggs from some patients and conducted extensive laboratory inquiries on others patients, failing to obtain consent in either endeavor.

Much of the research, Korenman contended, was done by each of the three doctors as part of their own individual “agendas.”

“During the course of our investigation,” he said, “it became apparent that the research consenting process was also a problem, just as the clinical-care consenting process was presenting itself as a major problem. So a research ethics investigation began separate from our initial inquiry.”

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Korenman defined the research as “comparing different methods of trying to get people pregnant, different methods of in-vitro fertilization . . . which, in and of itself, was fine. But what they forgot was this: Something that’s of critical importance in the way that modern American physicians deal with patients is the patient has to be capable of making rational decisions.

“You have to respect and honor the patient’s autonomy. In our system, they are given the decision-making ability; they are asked for informed consent and must be fully informed of all dimensions of what the physician wishes to do.

“For instance, I tell all my patients: ‘I’m going to tell you the truth, the whole truth and nothing but the truth. And No. 2, you’ll then make the decisions based on what I’ve told you.’ This is the mandatory relationship for doctors and patients in terms of both clinical care and research, and that was violated.”

Korenman said he regarded “the egg issue” as a far more egregious concern, “because a fertilized egg is the beginning of a human being. I mean, to take it without permission and give it to someone else is, well, really a step beyond any accustomed practice.”

Each of the center’s three doctors “played his own role in the operation of the enterprise,” Korenman said. “We made some distinction between the various responsibilities and, for that reason, decided not to cite a fourth physician,” whom the panel exonerated in its findings.

As for the other three, Korenman said, “rather than a deliberate attempt to deceive the patient, I think they were actually well-meaning . . . well, OK, only sort of well-meaning. I don’t think any patients were harmed” by the research conducted without consent.

Korenman said he believes the UC Irvine case will come to represent a turning point in how reproductive centers across the country manage their affairs, adding: “It’s very important to not only evaluate these things but also to make everyone aware of it, so that fertility clinics throughout the United States make sure of the ways they approach things.”

He said he believes that UC Irvine was “extremely forthcoming in trying to deal with this in a rational way. The university had no reason to believe in advance that a) there was anything to it, or b) the extent of it. It was then our job to deal with the allegations in terms of clinical malpractice, or malfeasance, if you will.”

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Korenman said the inquiry began in September and involved about 15 interviews, some conducted jointly by all three panel members, others separately, some in person, some on the telephone.

Initially, the inquiry involved only the clinical aspect of the allegations, “but it became clear,” Korenman said, “that they were writing papers related to the allocation of patients to different treatment categories and that reports were being made on this--scientific [research] reports, which also involved no consent.”

“In the end,” he said, “we were all very disturbed by what we found and hope our work contributes . . . to it never happening again.”