UC San Diego Also Says Asch Misused Eggs and Embryos

The scandal surrounding fertility specialist Dr. Ricardo H. Asch widened yet again Tuesday, when officials at UC San Diego accused him of taking at least two dozen eggs and embryos from patients there and giving them to a University of Wisconsin researcher without patient permission or UCSD approval.

In addition, officials announced UCSD has placed an unidentified senior faculty member on probation and is investigating as many as three other unnamed physicians for allegedly conducting unauthorized research at the La Jolla campus on “nonviable” human reproductive tissue--possibly including discarded eggs.

According to an ongoing, independent audit by KPMG Peat Marwick, Asch provided human reproductive tissue to a researcher at the University of Wisconsin-Madison without obtaining permission from either the patients or UCSD’s Human Subjects Committee.

UCSD officials said they learned only last month that Asch had provided Wisconsin researchers with 21 fresh, experimentally inseminated eggs and three frozen embryos.

“These new findings, if true, are disturbing, disillusioning and disgraceful,” Dr. Thomas Moore, acting chairman of UCSD’s Department of Reproductive Medicine, said Tuesday at a news conference. “The physician-patient relationship, particularly in the personalized setting of fertility treatments, requires a substantial measure of trust. Unconsented manipulation or redistribution of reproductive tissues represents an unthinkable and wholly unacceptable breach of that trust.”

One of Asch’s attorneys, Josefina Walker, said Tuesday the famed fertility specialist is free of blame.

“Dr. Asch went to UCSD to help them start a fertility program,” Walker said. “To that extent, he presumed that the office there was getting all the approvals and permits necessary to start the program. He was only supposed to deal with the surgical, medical side, which, of course, was his expertise.”

In response to allegations that Asch supplied eggs and embryos for research purposes to a University of Wisconsin professor named Gerald Schatten, Walker said Asch “never gave him any embryos at all.”

Echoing a theme struck repeatedly by Asch in a recent deposition, Walker said it was entirely the responsibility of those working under Asch to manage consent forms.

Asch, along with two of his colleagues at UCI--Drs. Jose P. Balmaceda and Sergio Stone--are now the subject of at least seven investigations into alleged misappropriation of eggs and embryos, insurance fraud, research misconduct and financial wrongdoing. All have denied any deliberate malfeasance.

At least 33 former patients have sued Asch, UCI, UCSD or the UC Board of Regents.

Though one of two internal probes at the University of Wisconsin is ongoing, the university has determined that Schatten “was substantially in compliance with human subjects regulations,” said Helen Madsen, general counsel for the University of Wisconsin-Madison.

“He expressed real dismay and shock that this happened,” Madsen said. “He also felt somewhat victimized by this thing. He was acting in good faith. They were doing some pretty important research . . . and then to find out there were problems with patient consent, it was shocking.”

Madsen said Schatten received repeated verbal and written assurances from Asch that the egg and embryo research had been approved by patients and by a UCSD review board. And Schatten’s research was subsequently approved, based on those assurances, by the University of Wisconsin’s own review board, she said.

Moore said Tuesday that Asch had repeatedly assured UCSD officials as well that he had obtained the appropriate approval from UCSD’s Human Subjects Committee before harvesting the eggs.

Melanie Blum, an Orange attorney, filed a lawsuit two weeks ago contending that Asch and Schatten took an unknown number of eggs or embryos from her 37-year-old client and used them in research without her permission.

The lawsuit by Santa Ana resident Annette Pfister, which alleges fraud, is the only one to target Schatten so far. It names as defendants UCSD, the University of Wisconsin and several other individuals and agencies.

Blum said Schatten, during visits to Asch’s clinics, basically destroyed her client’s eggs or embryos in the process of preparing them for research.

“I think the University of Wisconsin had an obligation to do more than just inquire as to whether patients consented,” she said. “You don’t take someone’s eggs and embryos without checking their consent in writing. You have to be more careful with genetic material.”

Among other findings, UCSD’s auditors determined that:

* Informed consent by patients for various procedures was not consistently documented in patient records by Asch, whom auditors deemed responsible because he was in charge.

* The UCSD tissue bank was not licensed in accordance with state requirements, because of UCSD’s “erroneous understanding” that Asch’s valid tissue bank license in Orange County covered the site in La Jolla. UCSD has since received such a license.

* Payments made to Asch and those who worked under him in La Jolla were not reported to UCI, Asch’s primary employer, as required under university rules.

UCSD laid much of the blame on Asch for problems at the La Jolla clinic. But Dr. Daniel Masys, the institutional officer for UCSD’s committee overseeing research on human subjects, said at the news conference that as many as four physicians at the La Jolla campus--including a senior faculty member now on probation--had erred in not reporting UCSD-based research on discarded reproductive tissues to the committee.

This research on “nonviable” tissue was apparently unrelated to that at the University of Wisconsin and did not require patient consent, said UCSD spokeswoman Leslie Franz. But it probably should have been reviewed by a UCSD panel, she said.

UCSD officials noted repeatedly that Tuesday’s announcement concerned only reproductive material that, in Moore’s words, “remains on glass . . . under a microscope” and, for all intents and purposes, could not possibly have been used to create a child.

In the wake of the allegations against Asch and his colleagues, UCSD has instituted numerous oversight procedures to prevent such occurrences in the future, Masys said.

In an oft-repeated refrain Tuesday, UCSD officials said they felt “betrayed” by Asch, whom they had regarded as a physician of “impeccable character” before the scandal broke. However, they admitted having made no inquiries into Asch’s character before he was hired.

“He invented many of the procedures we’re talking about,” Moore said. “As far as I’m aware, there were no concerns about his research or clinical behavior [when he was hired]. . . . UCSD did not become aware of these problems until very late in the game,” in January 1995.

However, Asch continued to see patients in La Jolla until June because the university believed the allegations against him were limited to “research concerns” and not “clinical concerns,” Moore said.

“In retrospect,” he said, “it appears that the trust that was placed in Dr. Asch was unfounded.”

A once-famous and internationally renowned fertility specialist, the Argentina-born Asch began working at a UC Irvine affiliate in Garden Grove in 1986, then later moved his practice to the university’s Orange campus.

From February 1993 to June 1995, he also headed the Assisted Reproductive Technologies program at the UC campus in La Jolla, where he treated 155 women. Unlike UCI’s pioneering program, which university officials have shut down, UCSD’s continues to operate.

Last year, during what university officials called the first phase of their investigation of Asch’s activities at UCSD, they disclosed that Asch had allegedly involved five San Diego patients in two procedures, failing to obtain consent from the three whose eggs or embryos were implanted in others. Those procedures resulted in one live birth.

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Report Highlights

UC San Diego recently completed the second phase of an ongoing investigation into the practices of Dr. Ricardo H. Asch at its Assisted Reproductive Technologies program. Asch headed the program from February 1993 to June 1995, while also managing the Center for Reproductive Health at UC Irvine. The major findings of independent auditors KPMG Peat Marwick announced Tuesday:

* Asch provided human reproductive tissue to a researcher at the University of Wisconsin-Madison without appropriate patient consent or approval by the UCSD Human Subjects Committee. Asch left “no clear record” of these transfers having been made.

* Administrative, operational and financial relationships between USCD and Asch were never clearly defined or documented.

* Informed consent by patients for various procedures was not consistently documented in patient records by Asch, whom auditors deemed the responsible party because he was in charge.

* The UCSD tissue bank was not licensed in accordance with state requirements, because of UCSD’s “erroneous understanding” that Asch’s valid tissue bank license in Orange County covered La Jolla. UCSD has since received such a license.

* Payments made to Asch and those who worked under him in La Jolla were not reported to “the UC Irvine compensation plan . . . as was required by UCI,” Asch’s primary employer.

Source: UC San Diego