In Embryo Suit, Cornell’s Role Highlights Gray Area

Previously undisclosed court documents support allegations that a Cornell University researcher used human embryos taken from couples at UC Irvine without getting required patient consent.

Officials from Cornell’s Medical College in New York City have long acknowledged that the school tested embryos in 1994 for UCI’s Center for Reproductive Health. The world-renowned fertility clinic was shut down four years ago after its staff was found to have been stealing eggs and embryos from patients.

But the new developments underscore concerns that Cornell, in response to a federal investigation three years ago, said it had performed clinical work when it actually had done research on the embryos. The distinction is a critical one because rules governing such research are more strict than those governing clinical work, which benefits the patient.

Beyond the implications for Cornell, such improprieties--if proved--would show that a second major medical institution violated federal regulations governing the use of embryos, and questions would be raised about activities at fertility centers nationwide.

“It is the last wild frontier in medicine, in some ways,” said Arthur Caplan, a bioethicist at the University of Pennsylvania. “It’s not that people are ignorant of the rules. . . . There is a lot of laxness in implementation.”

Lawyers for Cornell deny any wrongdoing by the institution and say the Cornell scientist was told by UCI at the time that patients had given consent.

But a top federal official who reviewed the documents, which came to light in civil lawsuits involving former UCI patients, concluded last week that Cornell did research on the embryos and never obtained the written consent required for human subject experimentation.

“This was research,” said Gary Ellis, who heads the National Institutes of Health office charged with protecting patient rights.

The fresh concerns about Cornell are surfacing as UCI wraps up its liability in the fertility cases, spending nearly $20 million settling all but a few of the 113 lawsuits filed against it by couples who had their eggs and embryos stolen while being treated at the UCI fertility center run by Drs. Ricardo H. Asch and Jose P. Balmaceda.

The lawsuits against Cornell were filed in Orange County in 1995 by two California couples whose embryos were shipped to the New York City medical center from UCI. The suits charge Cornell with fraud and professional negligence for using the embryos in research without learning whether patients had given consent.

Lawyers for the couples expect to take depositions in the Cornell case this summer. Cornell attorneys said they will try to have the suits dismissed this month.

Study or Treatment? Imprecise Definitions

Among documents filed in the cases by plaintiffs’ attorneys is a short letter to Asch--dated Aug. 25, 1994--in which then-Cornell scientist Santiago Munne discusses embryos he got from Asch’s lab and asks for more.

“I am writing you regarding the collaborative study on the . . . analysis of frozen human embryos,” Munne begins. He enclosed a sheet of data with results from tests already done on 13 UCI embryos as well as 57 other embryos cultured at centers in Australia, Italy and at Cornell.

“I was wondering if you can send me 10 embryos more,” writes Munne, saying he wants to “round the numbers for publication.”

Cornell attorney Beau Miller cautioned against taking the letter out of context and misinterpreting it. Munne, an expert in the field, was not doing research on the embryos, but rather conducting a quality-control test for Asch’s lab to determine if the medium used to culture the embryos caused chromosomal abnormalities, he said.

Reporting the results from the UCI tests along with findings for other labs “doesn’t turn the [UCI] test into something else,” he said. “It is a clinical test.”

Miller also said the test on the embryos could have been done for clinical reasons but then put to “a dual purpose.” The definition of research is not so well-defined and that “is where we get into problems,” he said.

The lack of clear distinction between research and clinical work at fertility centers nationwide is a concern of many bioethicists. Because such research is funded by the clinics themselves, it is conducted with virtually no federal or other oversight.

“There is confusion of research and treatment, and the labs are able to call it whatever they want when something is questioned,” said George Annas, chairman of the health law department at the Boston University School of Public Health and a member of the ethics committee of the American Society of Reproductive Medicine.

Ellis, from NIH, said his agency “has seen a startling ignorance about protecting human subjects in reproductive research at some major biomedical institutions.”

Some of those problems could be avoided, ethicists say, if the federal government funded and closely monitored embryo research. Congress banned funding for such research in 1993.

“The dirty secret about fertility clinics is that they are not regulated at all,” Boston University’s Annas said, adding that without the scrutiny provided by a lawsuit or a scandal, “we don’t know what they are doing.”

At issue in determining whether the embryos at Cornell were used improperly are two standards for patient consent.

Consent for clinical work is looser. Generally, patients give consent to their physician that covers lab work or analysis of tissue no matter where it is done if it helps in that patient’s care.

Federal regulations on human-subject research, however, are much tighter. Human research generally cannot be conducted unless patients give written consent and that consent is in the hands of the researcher. In addition, all human-subject research must be approved in advance by a review board at the research agency.

Debate Over Extent of Cornell’s Duty

Particularly tricky are rules governing tissue and embryos, which are not by themselves considered human subjects. Researchers must obtain written consent from a patient who provides tissue, including embryos, if the tissue can be linked to the patient. Documents from Cornell show that all the embryos from UCI, as well as those from Cornell and Australia, were identified by the parents’ last name.

In contending that the university’s work was of a clinical nature, Cornell lawyer Miller pointed to an affidavit in which Munne, the Cornell scientist, testified that the tests were performed at Asch’s request. The work was done for clinical reasons, he said, and therefore Munne did not need to get a separate consent from the patients.

But several bioethicists said Cornell scientists should have checked with the parents or at least seen and verified written consent forms, even if it was clinical work.

Even a Cornell associate dean, Dr. Gregory W. Siskind, stated in a previously unreleased May 1996 report on the incident to the NIH that “consent would be required irrespective of whether the analytic procedures were regarded as research or as patient care.”

Cornell lawyer Miller said the dean’s statement does not contradict the university’s legal position in the case. “You cannot do anything with someone’s embryos without consent,” he said. “We agree with that, and as far as Cornell knew, UCI had gotten that consent.”

All parties agree that neither Cornell nor Munne obtained any research consent for this work. And Munne’s answers about how he learned there was clinical consent did not satisfy his Cornell superiors, who faulted him in their 1996 response to the NIH.

“Dr. Munne failed to obtain documentation that appropriate patient consent had been obtained for this use of the patients’ embryos,” Siskind wrote in his report to the NIH in May 1996. Siskind said in the report that Munne could not recall with whom he spoke about the consent issue at UCI. Munne relied “completely upon undocumented oral communication, via telephone, to assure himself that consent for this use” of the embryos had been granted by the patient.

The lawyer for one of the couples suing Cornell called that explanation implausible. “Santiago Munne documented everything,” said lawyer Melanie Blum. “He identified embryos by name and number and kept detailed records. It is not conceivable that he would fail to document this important telephone conversation, which gives him the consent to use these embryos.”

Asch sent as many as 20 embryos from at least six couples to Cornell, according to court papers and other documents. Several of the couples could not be contacted, but the two who are suing Cornell maintain that they signed consent forms at UCI that restricted use of their embryos for their own fertility procedures. Both have already settled with UCI.

In addition to the 13 embryos Munne analyzed and reported on to Asch, as many as five or six others were sent by UCI to Cornell but had to be discarded because of damage in thawing or lab preparation, according to a letter to Asch from a researcher working with Munne.

Kimberly Dubont and her husband, Michael, are one of the two couples suing Cornell. The other parents are Debra and Michael Beasley, who had twins.

The Dubonts had one child, Mikey, after undergoing fertility procedures at the UCI clinic in 1990. After conceiving, she had nine embryos frozen and stored there.

Kimberly Dubont, 36, who lives in Temecula, is still angry that three of the embryos went to Cornell.

“Someone stole them,” she said. “They are Mikey to me. Mikey was one of those embryos.”

Kimberly Dubont said she “never, never, never gave consent” for the use of the frozen embryos, though the center asked twice if she would donate them, once in a letter in April 1993 and again five months later in a conversation.

An entry on her UCI chart in September 1993 reads: “Spoke with patient. She’s interested in using her frozens ’94 [for future attempts to give birth]. Will let us know if she is going to [use them] or donate.”

“They weren’t just cells to me,” Dubont said. “I wanted to give them a chance at life, and I have done that with all of them except the ones they took away.”

This year, she had the remaining six embryos thawed at Hoag Memorial Hospital Presbyterian in Newport Beach. Five survived and were implanted, but, she said, she failed to get pregnant.