Fertility Fraud

THE ORANGE COUNTY REGISTER

Story appeared in the METRO section

on page B01

FERTILITY SCANDAL BEGETS CHANGES

MEDICINE: LAWS CRIMINALIZE CONSENT BREACHES AND SUGGEST STANDARDS, AND AWARENESS IS GROWING. BUT IS THIS ENOUGH?

Saturday, November 16, 1996

MICHELLE NICOLOSI
THE ORANGE COUNTY REGISTER

In the 18 months since UCI's fertility scandal unfolded, a world-renowned clinic closed, its three doctors were indicted, more than 80 civil lawsuits were filed and $1 million was paid to settle with just two couples.

But what has changed for thousands of patients still worried they might not be safe in the hands of their fertility doctors? Plenty, said Dr. David Adamson, president-elect of the Society for Assisted Reproductive Technology.

"Our profession has been profoundly affected by the alleged incidents at UCI," Adamson said. "I think it's important that we take the responsibility to do whatever is necessary to ensure physicians are providing the highest-quality medical care."

The changes include:

A 1992 federal law sponsored by Rep. Ron Wyden, D-Ore., requiring model certification guidelines for state fertility labs. But the U.S. Department of Health and Human Services was slow to fund the work. A year after the fertility scandal broke, HHS allocated $1 million.
Efforts by Adamson's group and others in the industry to work with the government to standardize how clinic-success rates are reported, helping patients determine which clinics are best at giving patients what they want: babies.
Efforts by doctors who say they have become more sensitive to patient concerns, some offering lab tours to patients to show how and where the work is done.
Closer scrutiny by patients, who ask more questions and do more research than before, doctors and patients said.

A state Senate bill authored by Sen. Tom Hayden, D-Los Angeles, that will become law Jan. 1 and make it a crime to steal human eggs. The same day, a bill authored by Assemblywoman Jackie Speier, D-Burlingame, becomes law, stripping a doctor of his license if he does not get proper consent to take eggs from patients.

Diane Aronson, executive director of the national infertility patient-advocacy group RESOLVE, said change is slow, but coming.

"I do feel encouraged," Aronson said. "There's been more dialogue within the professional community. That's been a very good sign."

The fertility scandal at the University of California, Irvine, Center for Reproductive Health broke in May 1995, with charges that its three internationally known doctors --Ricardo Asch, Jose Balmaceda and Sergio Stone -- had taken eggs from women without consent and implanted them as embryos in others.

At least 70 women were involved, and 10 children were born from stolen eggs, according to patient logs and interviews.

A federal grand jury in Los Angeles on Thursday indicted the doctors on 35 counts of using the U.S. mail to send more than $66,000 in fraudulent bills to insurers.

The doctors deny all wrongdoing.

In June 1995 -- shortly after The Orange County Register first reported the allegations -- Wyden urged federal Health and Human Services Secretary Donna Shalala to "move swiftly" to finally fund his clinic-certification law.

"Gross irregularities in California fertility clinics underscore the need to protect consumers. ... (Patients) deserve a system in which practitioners are required to meet technical and ethical standards," he wrote.

The HHS responded in May that $1 million would be allocated to fund implementation of the law. The effects of the law should begin trickling down to clinics and their patients within three years, Wyden staffers said.

Dr. Bill Yee, medical director of in-vitro fertilization for the Long Beach Memorial Medical Center, will fly east Monday to work with the Centers for Disease Control and Prevention on the model legislation mandated by the Wyden Act.

He said the model law will encourage more fertility labs to become certified, and will improve quality of care for patients nationwide.

About 100 of the estimated 300 U.S. fertility labs are certified by the College of American Pathologists. Yee helped write the CAP certification program.

Though labs won't be required to be certified, the names of those that do not will be published, and patients and insurers may stop patronizing them, Yee said.

Yee said the model law will improve protections, but Adamson of SART said he'd like to see fertility-lab certification be required.

He said this law will not stop doctors from being dishonest, but will help improve standards in the field.

"There's always going to be one rotten apple. We could never regulate honesty," Adamson said.

Standardizing success-rate reporting will be a boon to patients, he added.

Federal investigations of clinics in the 1980s found that many clinics charging patients thousands had failed to produce a single live birth.

"Clearly, there need to be standards," Adamson said. "There is a lot of momentum toward trying to make it more understandable to the public."

But not all take a rosy view of changes in the industry: Debra Krahel, a former UCI administrator who reported fertility-clinic wrongdoing, said the certification law and standardized reporting will not be enough.

"We need to develop and institute more criminal laws," she said. "Otherwise I think it's going to be a moot effort to throw a certification process out there that doctors don't have to adhere to."

Hayden's bill provides criminal penalties _ up to five years in state prison and a $50,000 fine. But that doesn't go far enough, says Art Caplan, biomedical ethicist at the University of Pennsylvania. Overall regulation and oversight of the industry is still insufficient, and no one is making moves to improve it, Caplan said.

"Nothing to date has made me think that anything is any different," said Caplan. "I still believe it's time to try and regulate who is at the clinics, to have tougher regulations about how they perform. Things are just as they were; nothing has changed."