Charges’ Impact Worries Many in Fertility Field

Fertility experts and medical ethicists reacted with shock Thursday to the latest allegations against a renowned UC Irvine trio of fertility doctors, with several also admitting to fears that the extraordinary case could have a devastating impact on their largely unregulated field.

But if the allegations against Dr. Ricardo H. Asch and his UC Irvine colleagues are proven, one stunned medical ethicist said Thursday, the case involves “the most devastating and disturbing actions in the history of assisted reproduction.”

The University of California on Thursday accused Asch and his colleagues, Drs. Sergio Stone and Jose Balmaceda, of transplanting patients’ eggs without consent, conducting human subject research without permission, administering fertility drugs not approved by the government and blocking investigations by hiding or altering medical records.

The allegations contained in the case, said Dr. Arthur Caplan, director of biomedical ethics at the University of Pennsylvania, involve a basic betrayal of the trust which is at the heart of the patient-doctor relationship. The accusations amounted to what he de scribed as a “devastating roll-call of transgressions.”

“To use embryos without permission and make another family find out the child they think was their own may not be, well, it’s the worst possible moral offense,” Caplan said. “If you were looking for moral catastrophes, I guess I’d say this is the Titanic out on the bioethics ocean.”

But others said they also worried about the effect the suit might have on the nature of such work and how it could victimize doctors who play by the rules.

“I don’t know what the hell’s going on anymore,” said Dr. George Tagatz, professor of obstetrics and gynecology at the University of Minnesota. “These guys all think they’re playing football. They play by their own rules. We feel a personal impact because of the ethics, or the lack of ethics, involved in this.”

Tagatz said he was familiar with Asch’s work, having once reviewed his contribution to an article he published in Fertility Sterility, the journal of the American Fertility Society.

“He’s done astounding things with his career,” Tagatz said of Asch. “But you and I both know you don’t do the things [that Asch is alleged to have done]. If you do, it’s anarchy. You can’t run a society when people do things like this. It’s against every fundamental rule of the human experience, of life itself.”

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In essence, Tagatz said he regarded the charges as “absolutely spectacular. . . . But it’s one of a whole series of things that have gone on in medicine in recent years. I guess it shows that the personalities of men haven’t changed that much over the years, have they?”

Caplan said the reverberations were likely to be even more severe because Asch and his colleagues are leaders in the field.

“These aren’t people on the fringe. It’s not like this was done at a new clinic or a seat-of-the-pants operation,” Caplan said. “These people were pioneers. It’s certainly going to raise questions that will reverberate around the University of California system and throughout the nation.”

The concerns that patients almost always express to fertility doctors are likely to be magnified by the Asch case, another expert said.

“The first question people ask anyway is how do they know those are their own eggs,” said Dr. Jonathan Van Blerkom, co-director of Reproductive Genetics In Vitro, a Denver clinic. “There has to be a bond of trust.”

Dr. Joseph Gambone, director of the fertility center at the UCLA School of Medicine, said he clings to the hope that the charges against Asch are false and can be proven so.

“But if they’re true, the allegations are indeed incredibly serious,” Gambone said Thursday night in a telephone interview. “Undoubtedly, there will be--and probably should be--much stiffer regulations to come out of all this.”

In pondering the form such regulations should take, Gambone said he has thought for years that too many centers--at least 30 in Southern California--are doing such work. “And as a result, they’re far too difficult--in fact, they’re increasingly difficult--to regulate.”

“What I propose are fewer and larger centers, at which you’d have an ethics committee actually work as part of the center. The ethics committee would have oversight powers within the center, and as new methodologies come up, they’d be discussed among everyone.”

“And not everyone at the center should be a physician. In fact, it should be multidisciplinary in nature, which would go a long way in making sure these problems don’t happen in the future.”

At the very least, Gambone said, “It sounds as though something went terribly amiss in the [UC Irvine] system. The bottom line is, if the allegations are true, then certainly there should be a change in policy and process at UC Irvine. As it is, people simply won’t trust that institution as much as they used to.

“The University of California system is a pretty reputable group, so if it could happen at one of our campuses, it could happen anywhere, and we’ve got to do something about it.”

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But Hugh Hensleigh, director of the reproductive health lab at the University of Minnesota, which specializes in infertility and in vitro research, disagreed with Gambone about new and different regulations being necessary.

Hensleigh said labs such as his have been licensed under the Clinical Laboratory Improvement Act since 1988, “and those general guidelines already state that we must account for all of the eggs used in such procedures. If these allegations are true, [Asch] violated even that.”

In his lab, Hensleigh said, the process “is truly a team effort. It involves several people working together in a group. It takes at least four or five to even do an in vitro procedure.”

Hensleigh said that, while the tendency in the wake of such scandals is to saddle the process with sharper, more clearly defined boundaries, he isn’t sure they would make much of a difference.

“More regulations might help, but I’m not sure they would prevent something like this from happening anyway,” he said. “We have a lot of laws in the United States designed to keep people at bay, but people break them anyway.”

Hensleigh said he worries that the suit, regardless of its outcome, “will become a real problem for all of us. That’s my worry. I suspect it’s already having an impact, even as we speak.”