Fertility Scandal Widens Again
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 UC San Diego approval.
In addition, officials announced that UC San Diego has placed an unidentified senior faculty member on probation and is investigating as many as three other unidentified 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 in Madison without obtaining permission from either the patients or UC San Diego’s Human Subjects Committee.
UC San Diego 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 UC San Diego’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,” Moore said. “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 that the 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 colleagues at UC Irvine--Drs. Jose P. Balmaceda and Sergio Stone--are the subjects of at least seven investigations into alleged misappropriation of eggs and embryos, insurance fraud, research misconduct and financial wrongdoing. All have denied deliberate malfeasance.
At least 33 former patients have sued Asch, UC Irvine, UC San Diego or the UC Board of Regents. Although 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, school general counsel.
“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 UC San Diego review board. And Schatten’s research subsequently was approved, based on those assurances, by the University of Wisconsin’s review board, she said.
Moore said Tuesday that Asch repeatedly assured UC San Diego officials as well that he had obtained the appropriate approval from UC San Diego’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 UC San Diego, 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, university 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 school tissue bank was not licensed in accordance with state requirements because of UC San Diego’s “erroneous understanding” that Asch’s valid tissue bank license in Orange County covered the site in La Jolla. UC San Diego has since received such a license.
* Payments made to Asch and those who worked under him in La Jolla were not reported to UC Irvine, Asch’s primary employer, as required under university rules.
UC San Diego laid much of the blame on Asch for problems at the La Jolla clinic. But Dr. Daniel Masys, the institutional officer for UC San Diego’s human subjects research committee, said that as many as four physicians at the La Jolla campus--including a senior faculty member now on probation--had erred in not reporting university-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, a UC San Diego spokeswoman said. But it probably should have been reviewed by a university panel, she said. UC San Diego officials noted 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.