A Whistle-Blower’s Lament
This is the season Gene Ioli used to look forward to every year, when he would dress up as Santa Claus at the UC Irvine cancer center’s Christmas party.
His seasonal role was a symbol of his acceptance by researchers and others at the center, where they were working on a treatment for cancerous tumors.
Ioli, 44, counted himself among those who were not afraid to dream the impossible, and he built his life around work and UCI, buying a house close to the campus. Ioli and his wife, Marian, have two sons, 10 and 8, and a son, 25, and daughter, 23, from her first marriage.
“The friendships were very strong. The work was exciting. We were making a difference,” said Ioli, a lab technician who said he was hired in 1993 to manage the immunotherapy laboratory at UCI’s Chao Family Comprehensive Cancer Center.
Everything changed in December 1996, when the lab was closed after Ioli’s disclosure to university officials that an experimental treatment had been developed outside the accepted research protocol. His allegations led to discoveries that the lab had a researcher working on federally funded research who had been temporarily banned from such research, and that patients undergoing its experimental therapy had been improperly asked for gifts, among other findings. Suddenly, UCI was faced with the campus’ second major medical scandal since 1995.
“It was very painful,” Ioli said. “I lost a lot of good friends.”
Through his attorney Thomas E. Rockett, Ioli has pressed for a federal investigation in addition to the internal probe done by UCI. His allegations are now under investigation by the Food and Drug Administration and the National Institutes of Health.
Ioli said that researchers at the lab viewed him as a “loose cannon” for reporting the lab’s deviations from protocol in developing an experimental vaccine of immunized cells used in treating cancerous brain tumors.
Sitting in his lawyer’s office, Ioli recently discussed his decision in 1996 to expose what he considered an unacceptably adulterated research project.
UCI officials would say little about Ioli’s allegations. Researchers and staff members, some of whom worked with Ioli for almost 10 years, did not return repeated telephone calls for comment.
Ioli says his insistence on protocol cost him his job--he says he was fired two years ago--and the opportunity to be in on the discovery of a cancer cure.
“I did it because of the patients,” he said.
UC Irvine Officials, Technician at Odds
Ioli has listed himself as lab manager at UCI. Dr. Yutaka Kikkawa, former head of the College of Medicine’s pathology department, said the technician was the only employee of the immunotherapy lab. Kikkawa declined to comment about Ioli.
However, Kikkawa, who resigned last week as chairman of the department, suggested that Ioli acted prematurely when he went to university officials with allegations that the lab was deviating from protocol.
“How do you take just one side of the story without studying the other side too? There was and is another side to this issue,” Kikkawa said without further elaboration.
UCI officials, who have said privately that they expect a lawsuit from Ioli, refused to comment on his allegations or say whether he was fired.
However, a Dec. 30, 1996, memo written by former immunotherapy lab director Dr. James Thompson that was released by UCI officials Friday described him as a “difficult” employee.
Thompson, who became lab director in December 1995, wrote that “from day one it was obvious to me that he [Ioli] had a chip on his shoulder.” Furthermore, Thompson wrote that “Ioli had a suspicious nature” and “his constant complaints, many of which I investigated and found groundless, were a nuisance.” Ioli also often circumvented his authority, Thompson said.
For Ioli, the lab was the closest he got to practicing medicine. A graduate of State University of New York at Buffalo, he had wanted to become a doctor but he said he didn’t have the grades. Instead, he took bachelor of arts degrees in political science and biology, according to his resume.
After moving to Southern California 16 years ago, Ioli worked at several hospitals and private laboratories as a lab and clinical technician in the fields of hematology, tumor biology and immunotherapy, according to his resume. Five years ago, Ioli said he was hired to work in the UCI cancer center’s immunotherapy lab at $44,000 per year.
Ioli said he dedicated his career to working in a scientific environment to find an effective cancer treatment. So when UCI researchers apparently altered a procedure to develop immunized cells to treat cancerous brain tumors, Ioli reported it to university officials, who launched an internal investigation. In December 1996, UCI closed the immunotherapy lab where Ioli and the researchers worked.
According to Ioli, protocol mandated by federal regulations required the cancer treatment to be developed from a strict formula using cells from a healthy donor and the patient. He said the researchers were not getting the expected results with the required formula, so they added extra cells from the healthy donor, “achieving a bogus result.”
UCI officials investigated this and other allegations made by Ioli. In an April 1997, report, the university said that researchers at the immunotherapy lab “grew cells which were used to produce test articles without appropriate approvals” from UCI or federal officials. In addition, the university’s investigation found that researchers used “an unapproved cell preparation for purposes of research.”
Ioli said the altered immunized cells were used to treat patients at Good Samaritan Hospital in Los Angeles. Paul Kells, vice president of administrative and support services for the hospital, confirmed that Good Samaritan and UCI collaborated on the experimental cancer treatments used on the hospital’s patients, but said the program ended about three years ago.
He declined to comment on Ioli’s allegation that the research used to manufacture the immunized cells was altered. He said that Good Samaritan “followed the guidelines used within the industry to regulate research at our end. We treated our patients through the accepted protocol.”
Ioli said his concern about patients is what ultimately led him to come forward.
“The patients are the bottom line,” Ioli said. “They came to the university because it was their last hope. Many of them felt they were making a contribution to science and other patients.
“Being part of this experimental research was their last contribution to life. If you as a researcher can’t abide by the laws set down by the federal government in doing the research, . . . if you can’t give these people what they’ve asked for and you promised them in their last days of life, you’re committing a fraud.”
New Research Job With Private Firm
Ioli said his decision to complain has made him a pariah among the people he counted as friends before the UCI internal investigation began. Then, he said, he was dismissed from the cancer center in July 1997, and now works at Allergan Inc., where he is engaged in research to find a cure for glaucoma.
He said that UCI researchers and officials were already reeling from the school’s fertility clinic scandal in 1995 when he brought another scandal to their attention. Doctors from the now-closed fertility clinic were accused of ethical misconduct that included transplanting patients’ eggs without consent in other women.
Ioli sees the two scandals as related. Both stem from lack of supervision of medical research, he said.
“What this says is that there is no infrastructure in human subject research oversight,” Ioli said. “They have a lot of nice, modern buildings where research takes place but nobody to make sure that what goes on inside amounts to ethical conduct.”
