UCI Panel Faulted Lab a Year Before Shutdown
A UC Irvine medical committee found sloppy research practices and poor oversight at a Chao Cancer Center lab more than a year before a research project there was shut down for violating university and federal regulations on experimental treatments, UCI records show.
The special review committee was formed in October 1995 at the behest of the cancer center’s director to determine if fraud or other improprieties had occurred in the laboratory conducting research on “mixed lymphocyte culture” cancer treatments.
Among the committee’s findings:
* Dr. John C. Hiserodt, then a UCI researcher, submitted a fraudulent application to a university review board for a proposed prostate study. Hiserodt had already been sanctioned by the National Institutes of Health the year before for fabricating research in a federal grant application and banned from participating in federally funded research.
* Patients in experimental clinical trials had been asked to give “gifts” to the university to cover medical costs. The report called the gift requests “inappropriate” and said they put the university “at risk.”
* The university “exercised no clear oversight” of applications to the U.S. Food and Drug Administration for new drugs and medical devices and did not offer any assistance to researchers to ensure they complied with U.S. Food and Drug Administration requirements. In fact, some researchers were never told their work was being used in submitting applications or asked to participate in preparing the applications, the committee found.
The five-person committee, formed by cancer center director Dr. Frank Meyskens and chaired by Dr. Winston Ho, director of the center’s bone marrow transplant program, found that many research studies had “sloppy or incomplete preparation, poor coordination and communication,” the report stated.
UCI biochemist Gale Granger, head of the team conducting the mixed lymphocyte culture research, told a top UCI administrator in a 1997 letter that the cancer lab had some organizational difficulties but said they were corrected after Ho’s committee released its report.
Ho, Hiserodt, Granger and Meyskens could not be reached for comment Saturday. University spokesman Tracy Childs said UCI administrators were not available for comment.
UCI officials maintain that they became aware of problems in the lab in September 1996, when Gene Ioli, former manager of the cancer center’s immunotherapy lab, alerted the university about unauthorized research being conducted there. The lab was padlocked in December 1996 and UCI launched an internal inquiry.
But it was in late 1995 that Ho’s review committee began raising questions about the lab, including allegations that patients had been asked to make gifts to the university to cover the costs of their treatment.
Although it’s not unusual for hospitals and university medical centers to ask former patients for donations, making such a request of patients undergoing treatment is an “irregular” practice, said Barbara Koenig, executive director of Stanford University’s center for biomedical ethics.
“It’s very complicated to do that in a correct and ethical way,” Koenig said.
The committee, which met six times in October and November of 1995 before releasing its findings in December of that year, found only one instance in which a lab study was considered fraudulent.
It was an application for a prostate/bladder study submitted to the university’s investigational review board, which monitors all human-research work.
The committee found that Hiserodt and Dr. Thomas Ahlering, a UCI professor and chief of the urology division, removed Hiserodt’s name from the application even though Hiserodt originated the study idea. Hiserodt and Ahlering replaced Hiserodt’s name with those of Meyskens and Granger, according to Ahlering.
In a letter to Rep. Christopher Cox (R-Newport Beach) this summer, Ioli cited the committee’s findings about Hiserodt removing his name from that study as one piece of evidence that UCI ignored numerous signs that Hiserodt engaged in improper activities.
“Keep in mind, this was a new lab that was just getting started up,” Ioli said. “Still, that doesn’t excuse what people did in the lab.”
The FDA has an ongoing criminal investigation into reports that Hiserodt developed an unauthorized experimental treatment in the UCI cancer center lab, and later shipped a dose to Miami to treat a dying Florida girl, according to UCI officials and a 1997 university inquiry.
That inquiry reviewed 11 allegations of improper research at the cancer center lab, including the matters involving Hiserodt. Hiserodt took a leave of absence while the inquiry was underway and resigned after its release.
