UCI Hiring of Cancer Doctor Questioned

The dean of the UC Irvine College of Medicine said Friday that he “can’t even begin to understand” how the university hired a cancer specialist who was under federal investigation for falsifying research at a previous job.

The specialist, Dr. John C. Hiserodt, according to a 1997 university inquiry, later violated federal restrictions on the use of experimental drugs on cancer patients while he worked at a UCI Chao Cancer Center laboratory.

The university acknowledged this week that federal health authorities are reopening the UCI investigation.

Thomas Cesario, the university’s dean of the College of Medicine, said the university took appropriate steps immediately to correct problems it found. School officials padlocked the research laboratory once the allegations of unauthorized research surfaced in 1996.

They also monitored Hiserodt closely throughout his stint at UCI and sent three warning letters, two of which specifically ordered him to stay away from the UCI Cancer Center, Cesario said.

State regulations protecting university employees prevented the university from dismissing Hiserodt, Cesario said.

Still, university officials were at a loss Friday to explain why UCI hired Hiserodt in July 1993, while the federal government was investigating allegations that he had submitted a falsified grant application three years earlier. The application was for his work at the University of Pittsburgh Medical Center.

“I’ve asked myself the same question many times,” said Cesario, who became dean after Hiserodt was hired. “I don’t know the answer to that.”

William Parker, UCI’s associate executive vice chancellor who oversaw research in 1993, said he was never told of the pending allegations when Hiserodt was offered a job and was unsure if anyone at the College of Medicine was aware of the matter.

However, Gene Ioli, former manager of the cancer center’s Immunotherapy Laboratory, said Friday that everybody who worked there knew about the allegations against Hiserodt shortly after he came aboard.

“A number of people in our group were a little bit taken aback that we were working with Dr. Hiserodt,” said Ioli, whose complaints in 1996 launched the investigations into the cancer center’s research practices.

At the time, Hiserodt had only a temporary position at UCI. He was hired full time as an assistant professor in February 1994, according to the university.

A month after UCI hired Hiserodt full time, the U.S. Department of Health and Human Services barred him for five years from participating in federally funded cancer research projects because of his “scientific misconduct” in Pennsylvania.

Cesario said the three warning letters sent to Hiserodt were precautionary measures to ensure he abided by the federal directive prohibiting his involvement in certain research projects.

UCI receives $35 million a year in federal money for the cancer center and other cancer research, and the university didn’t want the funding to be put at risk, he said.

“We were being absolutely sure, as sure as we could, that no one could construe anything that he was doing as anything related to federally funded research,” Cesario said.

In March, 1994, when federal health officials alerted UCI of the research ban on Hiserodt, Parker said he withdrew a series of grant applications Hiserodt had submitted to the National Institutes of Health. Parker also notified Hiserodt’s supervisors at UCI Medical Center.

The inquiry sparked by Ioli’s complaint resulted in an April 1997 report finding that Hiserodt and other researchers at a Chao Cancer Center laboratory used unapproved cancer treatments on patients, violating university and Food and Drug Administration restrictions on human research.

In one case, an expired dose of an unapproved experimental compound was injected into the brain of a terminally ill Florida girl stricken with a brain tumor, who died soon afterward.

The university inquiry also found that Hiserodt’s work at the laboratory may have violated his ban from federal research projects and that Hiserodt’s colleagues at the cancer center ignored warnings not to collaborate with him.

The report concluded that the laboratory suffered from a “lack of oversight” that resulted in “very serious” violations of federal and university regulations.

Hiserodt was hired with the recommendation of Dr. Gale Granger, a UCI molecular biologist who headed the laboratory where Hiserodt worked, Cesario said.

Granger also conducts research at Meyer Pharmaceuticals in Newport Beach, a medical firm that hired Hiserodt after he left UCI.

Meyer Pharmaceuticals was one of a number of sources helping to fund Granger’s research at UCI. The company, under a licensing agreement with the university, currently conducts clinical trials related to new drugs developed at the cancer center and other UCI research facilities.

Officials at Meyer Pharmaceuticals refused to comment Friday. A company lawyer also declined comment on behalf of Hiserodt, who could not be reached.

Both the FDA and the National Institutes of Health launched new inquires this summer at the request of Rep. Christopher Cox (R-Newport Beach).

Cox intervened after receiving a letter from Ioli’s attorney, Thomas Rockett, who alleged that the university conducted a shoddy inquiry. While three cancer center researchers were reprimanded, no disciplinary action was taken against Hiserodt. He took a leave of absence after the report was completed and eventually resigned in 1997, UCI officials said.

Cesario said there was little the university could do when they found Hiserodt had been punished for fabricating cancer research data in Pennsylvania. A suggestion to dismiss Hiserodt was discussed, but quickly dismissed, he said.

“It was felt by university authorities that we could not hold him accountable for things that were not done at Irvine, that were done at his previous institution,” Cesario said.

However, when Ioli alerted university officials that the laboratory where Hiserodt worked was violating federal restrictions on human research, UCI acted quickly and decisively, Cesario said.

“The lab was descended on by UCI officials, and all the materials were confiscated,” he said. “An investigation was begun, and the lab was never reopened again.”