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 UC Irvine's Center for Reproductive Health. The prestigious clinic, run by Dr. Ricardo Asch, was caught stealing eggs and embryos from patients four years ago and shut down.
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 crucial, because rules governing such research are stricter than those governing clinical work to benefit the patient.
Beyond the implications for Cornell, the improprieties--if proved--would show that a second major medical institution violated federal regulations governing the use of embryos, and would raise questions about embryo use 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 . . . [but] there is a lot of laxness in implementation."
However, a top federal official who reviewed the documents, which came to light in civil lawsuits involving former UC Irvine patients, concluded last week that Cornell did research on the embryos and never obtained the written consent required for experimentation on humans.
"This was research," said Gary Ellis, who heads the National Institutes of Health office charged with protecting patient rights.
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 more than a dozen embryos he has gotten from Asch's lab and asks if he can have 10 more to "round the numbers for publication." He enclosed a sheet of data from tests on other embryos from Australia, Italy and at Cornell.
Cornell attorney Beau Miller cautioned against taking the letter out of context and misinterpreting it. Munne 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.
Miller also said the test on the embryos was clinical but the results could then have been put to "a dual purpose."
The fresh concerns of possible impropriety by Cornell are surfacing at a time when UC Irvine has spent $20 million settling all but a handful of the 113 lawsuits filed against it by couples who had eggs and embryos stolen from them while being treated at the UC Irvine fertility center.
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 UC Irvine. The suits charge Cornell with fraud and professional negligence for using the embryos in research without learning whether patients had given consent.
The lack of a clear distinction between research and clinical work at fertility centers nationwide is a concern of many bioethicists.
"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, of the 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.
At issue in determining whether the embryos at Cornell were used improperly are two different standards for patient consent.
Consent for clinical work is looser. Generally, patients give consent to their physician and that covers lab work or analysis of tissue, no matter where it is done, if it helps in that patient's care.
Human research generally cannot be conducted unless patients give written consent and that consent is in the hands of the researcher.
In contending that the university's work was clinical, Cornell lawyer Miller pointed to an affidavit in which Munne, the Cornell scientist, testified that the tests were performed at Asch's request 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 patients or at least seen and verified written consent forms, even if it was clinical work.
Miller said that "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 a previously unreleased 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," wrote Cornell associate dean Dr. Gregory W. Siskind. He said Munne could not recall with whom he spoke about the consent issue at UC Irvine or when.
The lawyer for one of the couples suing Cornell said she found that explanation implausible. "It is not conceivable that he would fail to document this important telephone conversation, which gives him the consent to use these embryos."
As many as 20 embryos from at least six couples were sent by Asch to Cornell, according to court papers and other documents. Several of the couples could not be contacted for comment, but two who are suing Cornell contend that they signed consent forms at UC Irvine that restricted use of their embryos for their own fertility procedures. Both have settled cases against UC Irvine.
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 UC Irvine clinic in 1990. After conceiving, she had nine embryos frozen and stored at the clinic.
Kimberly Dubont, 36, who lives in Temecula, remains angry that three of those embryos were sent to Cornell. 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.
"They weren't just cells to me," she 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."