Shaken Fertility Industry Facing Probe Of Ethics -- UC Irvine Scandal Revives Calls For Clearer Guidelines

SANTA ANA, Calif. - New guidelines for the fertility industry will be written within the year by the American Medical Association because of the mushrooming scandal at the University of California, Irvine's fertility clinic, the organization's ethics director said this week.

The revelation of 30 allegations of improper transfer of human eggs at UCI's Center for Reproductive Health has increased pressure within the fertility industry - as well as outside it - to re-examine guidelines and laws, according to industry experts.

"How do we prevent this from happening?" said Dr. David Orentlicher, who directs the AMA's division of ethics and standards. "Have we seen enough problems with these clinics that we need more regulation?"

The answer will come on two parallel tracks: internal policing by the medical establishment and, possibly, new state and federal laws.

Committees of doctors within the AMA soon will begin analyzing standards already in place at fertility clinics across the nation, Orentlicher said. Next will be a report by the committees on how the industry should be further regulated, and how standards could be improved.

After examining the report, the AMA's House of Delegates, with about 400 members, will issue a new, more comprehensive policy on fertility clinics at one of two regular meetings, either December 1995 or June 1996.

Potential changes include boards or independent bodies that would offer voluntary certification to clinics after inspection or review, and recommendations for government licensing of clinics, or new government regulations.

Need for new laws debated

The AMA's policy will, in turn, influence the creation of new laws, Orentlicher said.

"I think it's probably been an area that has been inadequately regulated," he said. "The hard question is, what is the right amount of regulation?"

Too much regulation would drive up the costs of being treated at a fertility clinic, add unnecessary red tape that would provide little in the way of real protection and quickly grow outdated as technology improves, Orentlicher and other fertility experts said.

Many experts say the allegations against the UCI clinic, if true, represent flagrant violations of existing ethical standards. So, reviews within the medical establishment will concentrate on how to strengthen procedures already in place, rather than develop new ethical guidelines, according to doctors who help develop such standards.

The Society for Assisted Reproductive Technology already has begun revising one of the most important protections for fertility patients: the consent form.

That was a direct result of the UCI allegations, said Dr. Victor Knutzen, president of the society. The new form would expressly forbid the transfer of human eggs without consent.

`Sharpening the saw'

SART, as the society is called, routinely reviews its policies and guidelines, and a review of procedures for donations of embryos was under way before the UCI case came to light, he said. He believes the society already holds fertility doctors to an extremely high standard.

"What an incident like this does is sharpen the saw a little bit," Knutzen said.

Mary Fasshauer, administrator of SART, said that fertility doctors nationwide "are absolutely appalled" and saddened by the allegations. But, until now, fertility physicians have been split on how to react.

"One group will say these are well-trained people and, until something is proven, you must support well-trained people," Fasshauer said. "The other group says distance yourself quickly. This is not good."

Even before the medical community has formulated its response, some legislators are beginning their own campaigns for reform.

It's too late for new state laws in the state Legislature this term, but state Sen. Tom Hayden, D-Santa Monica, has said new regulatory legislation might be drafted in coming months for the next term. Hayden plans to hold a hearing on the UCI case this fall.

Little federal oversight

Federal oversight consists of one investigator with the Federal Trade Commission, which last month secured its first enforcement settlement in a fertility-clinic case in four years, according to congressional hearing reports. A Phoenix, Ariz., clinic agreed with the FTC to stop exaggerating success rates.

Congress did pass a law in 1992 to standardize the reporting of the infertility clinic success rates and to establish some clinic standards. The job of oversight was turned over to the federal Centers for Disease Control and Prevention in Atlanta.

But Kay Golan, a CDC spokeswoman, said because Congress didn't appropriate any money to do the job, the agency has turned the job over to a private group.

"What we have done is we've turned that over to the American Society for Reproductive Medicine, based in Birmingham, Ala., and we have worked closely with them and we feel they're doing a credible job," Golan said.

Dr. Benjamin Younger, medical director of society, said his group worked with U.S. Rep. Ron Wyden, D-Ore., to get the bill passed.

Charges of foot-dragging

The mounting allegations call for action, including consideration of a more comprehensive effort to protect the rights of patients, said Wyden, author of a fertility-clinic reporting law that has not been implemented.

Wyden criticized Health and Human Services Secretary Donna Shalala for refusing to fund a program to provide consumers information on success rates of fertility clinics. He said this law must be funded as the groundwork for any further congressional action.

While regulatory reform of the industry remains uncertain, it is likely that laws will be passed making the stealing of embryos a crime, said John Robertson, a reproductive law specialist at the University of Texas School of Law.

"It's theft," Robertson said. "But one way of underlining it in red is to pass a law that says that specifically."

Change needs to come, said Leslie Wolfe, president of the Center for Women Policy Studies, a think tank in Washington D.C.

"There was a massive abuse of trust and simple lack of professional ethics," Wolfe said. "Somebody has to develop a way for these clinics to be monitored."

Information from the Fort Lauderdale Sun-Sentinel is included in this report.