Fertility Expert Resigns Amid Probes at UCI

The founder of an internationally acclaimed fertility clinic said Saturday that he has resigned from the UC Irvine medical faculty amid allegations that he took eggs from patients without their consent.

At the same time, UCI Chancellor Laurel L. Wilkening announced that Dr. Ricardo H. Asch and his two partners at the UCI Center for Reproductive Health were placed on leave from the university, pending the outcome of investigations of medical and research practices at the center.

Also placed on leave, effective Friday, are Drs. Jose Balmaceda and Sergio Stone. It was unclear Saturday whether Asch’s resignation or the forced leaves occurred first.

“This immediate action was necessary in light of new information concerning allegations against physicians in the Center for Reproductive Health,” Wilkening said in a prepared statement.

She was referring to a recent allegation from a clinic patient who contends that one of her eggs was given without consent to another woman who subsequently gave birth.

Through his lawyer, Asch made his first public response to the allegations on Saturday, denying any wrongdoing and criticizing the university for reportedly shirking its responsibility for complaints that have surfaced. He said he resigned Friday because the university has created a “police-like atmosphere” at the clinic that has made it impossible for him to continue practicing medicine “in a quality fashion.”

Asch’s lawyer, Lloyd Charton, said Saturday that the chancellor’s action caught him by surprise. “It is just another indication of [the university’s] irresponsible behavior,” he said.

Asch is “indignant and outraged” by the attack on his reputation and denies having knowingly violated the wishes of any of his patients, Charton said. He also said Asch denies breaking human-research regulations set by the university and the federal government.

Charton said that Asch, one of the nation’s foremost fertility experts, contends that if any administrative mistakes were made at the clinic that led to the complaints, the university should share in the blame.

The university has severed its ties with Asch’s clinic, which must move out of UCI Medical Center in Orange by June 2. On Tuesday the university sued Asch, Balmaceda and Stone, alleging that Asch attempted to alter patient files that would show whether he had taken eggs from patients without the donors’ consent.

The university also contends that Asch and his partners at the UCI Center for Reproductive Health have conducted unapproved research on patients and have been withholding from authorities patient files and embryology reports that would reveal wrongdoing.

Balmaceda and Stone could not be reached for comment Saturday. Asch was out of town for the weekend, but faxed his resignation to the university at 5:30 p.m. Friday, his lawyer said.

Also Friday, the university hand-delivered letters to the homes of all three doctors, informing them about the leaves, said Fran Tardiff, a university spokeswoman. She did not know what time the letters were delivered.

Orange County Dist. Atty. Michael R. Capizzi said his staff planned to meet Monday with UCI police and California Medical Board investigators to review the allegations against the clinic.

Asch’s lawyer denied an allegation that he had used a woman’s eggs without her permission in 1993 and only last month asked her to sign a retroactive consent form. The allegation was included in court documents filed by the university Tuesday.

“I have not recently gone to anyone asking them to sign a consent form for procedures done in the past and deny any report to the contrary,” Asch said in a statement read by his lawyer. “Not only have I not done it recently, I have never done it in my career. And furthermore, I have never asked anybody to change a medical record.”

Charton also said Asch “absolutely never harvested eggs from a woman and then used those eggs intentionally in contradiction to the instruction of the patient.”

Charton said Asch isn’t certain of the identities of the women who have prompted these charges.

“He would love to know the identity of the people who anonymously point a finger at him and accuse him of wrongdoing because he would like to confront them and explain to them that they are wrong, inaccurate,” Charton said.

Charton said that Asch, as a pioneer in the field of fertility medicine, had “dedicated his entire career to helping people” and until now had not paid much attention to the importance of making certain that legal protocol was followed at his clinic.

“All of a sudden he finds himself involved with a nest of lawyers, and all of a sudden he finds himself understanding that he has to focus more upon legal forms, consent forms and authorization forms,” Charton said.

Asch gained international prominence by pioneering the GIFT procedure, in which a woman’s eggs and a man’s sperm are placed in the woman’s Fallopian tubes, where conception naturally occurs.

Charton said Asch had taken for granted that others were keeping track of embryos and records. “He thought the administration at the university and the clinic were handling that to the satisfaction of the patients,” Charton said. “It was always his impression the office was run professionally enough that these administrative details were being properly and ethically handled.”

Under the clinic’s contract with the university, Charton said, the university had agreed to provide the clinic with administrative assistance.

Asch had no choice but to leave UCI, his lawyer said.

University officials “have made it unreasonable and untenable for him to continue his practice of medicine with them,” Charton said. “They have seized records and charts and created a police atmosphere with security guards.”

* ASCH GETS SUPPORT: Patients and staff, shaken by allegations, praise doctor. A22

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Expanding Inquiry

UCI officials said the following events led to the university’s decision to place three doctors on leave at Center for Reproductive Health:

February, 1994

* Allegations about clinical, fiscal and management practices made against the Center for Reproductive Health.

* UCI Medical Center management requested an internal audit

March, 1994

* Investigation begun by the university’s Internal Audit unit.

April, 1994-July, 1994

* University auditors unable to obtain cooperation from the fertility clinic’s physicians.

July, 1994

* New allegations involving management and fiscal issues made against the clinic.

August, 1994

* Internal Audit referred clinical issues about the fertility center to the medical staff for further investigation.

September, 1994

* Formal allegations are made by the university’s legal counsel.

* Three outside investigative panels are appointed to investigate clinical, fiscal and management practices at the fertility clinic.

October, 1994

* Investigations begin that involve interviews with dozens of witnesses and reviews of thousands of documents.

January, 1995

* The Office for Protection from Research Risks (OPRR) of the National Institutes of Health visits fertility clinic to review compliance with federal regulations regarding research on humans.

* OPRR meets with UCI administrators to discuss alleged violations of human research standards by members of the fertility clinic.

* UCI Vice Chancellor for Research Frederic Wan launched a preliminary inquiry into the OPRR’s allegations of scientific misconduct against the fertility clinic.

February, 1995

* Executive Vice Chancellor Sidney Golub informs OPRR of actions the university has taken to gain control over clinical research activities at the fertility clinic.

March, 1995

* The university’s panel investigating clinical practices files with Vice Chancellor Wan a separate allegation about research misconduct at the clinic. Wan initiated an inquiry into the allegation.

April, 1995

* UCI terminates the Practice Management Agreement between the university and the fertility clinic.

* Chancellor requests a medical staff investigation.

* Executive Vice Chancellor Golub reports to federal and state agencies and the OPRR the status of the university investigations.

May, 1995

* UCI files suit against Drs. Ricardo H. Asch, Sergio Stone and Joseph Balmaceda and the fertility clinic to seek preservation and return of documents and equipment. The university’s request for a temporary restraining order is denied by Orange County Superior Court Commissioner Sheila B. Fell, saying there was insufficient evidence the doctors had tampered with documents.

* Asch resigns from the UCI medical faculty. The university puts Asch, Stone and Balmaceda on leave from the medical school faculty pending completion of the investigations.

Source: UCI