Papers Show Experimental Treatment of Girl by UCI

Newly released documents show that a cancer-stricken Florida girl was given experimental treatments in a UC Irvine program after intervention from higher officials, and that two cancer doctors conducted “clandestine” research to help her.

The girl was treated in a UCI clinical trial designed for adult cancer patients as a “result of strong pressure exerted by the family and their influential friends on campus officials and our group,” according to a 1997 letter written by UCI biochemist Gale Granger, who headed the research team.

The letter was one of five written by Granger to UCI officials in response to an internal inquiry into reports of unauthorized cancer research at his laboratory in the UCI Choa Family Comprehensive Cancer Center.

Among those intervening on behalf of Jennifer Turken of Miami Beach was Leon Panetta, then the White House chief of staff, according to a Dec. 8 report sent to UCI administrators by Yutaka Kikkawa, chair of the pathology department.

The report and Granger’s letter, though, do not make it clear whether Panetta asked the university to put her in a federally approved experimental program in 1995 or to give her doses of an unapproved cancer vaccine in 1996.

Panetta, Granger, Kikkawa and Robert Turken, Jennifer’s father, could not be reached for comment Thursday.

After receiving federally approved treatments at UCI, Jennifer was returned to Miami, where she then received doses of the unapproved vaccine a month before she died, according to the university’s inquiry.

Granger’s letter states that the girl’s family and its “influential” friends pressured UCI officials to accept the girl in the approved adult program. The Kikkawa report says the Turkens, seeking use of the unapproved vaccine, contacted Panetta and Panetta called a university official. She then was given “compassionate approval,” Kikkawa wrote.

In one 1997 letter, Granger also said the experimental cancer vaccine used to battle the girl’s brain tumor was developed without his approval or that of the U.S. Food and Drug Administration.

The FDA is conducting criminal and regulatory investigations into allegations of unauthorized research being conducted, university officials confirmed this week.

The federal probe includes UCI’s own finding that Dr. John C. Hiserodt, a former university cancer researcher, violated federal law by shipping the unauthorized cancer vaccine to the Miami hospital.

Granger took a leave of absence while the UCI inquiry was underway and resigned after its release late last year. Two other university researchers were sanctioned by the university.

The inquiry also found that Hiserodt may have violated a five-year ban on his involvement with any federally funded research. In 1994, the National Institutes of Health barred Hiserodt from such work after determining that he had falsified reports while working at the University of Pittsburgh Medical Center.

Hiserodt declined to comment.

He and another researcher developed the cancer vaccine, a laboratory culture of the girl’s own white blood cells, in a research unit headed by Granger, who received private grants to fund the unit. However, Granger said in one of his letters that it was done without his permission.

“This was a clandestine effort conducted without my knowledge and out of my sight,” Granger said in a May 9, 1997, letter to Frederic Wan, UCI’s vice chancellor for research. “However, they did employ my funds as a source of support. This problem has happened in many laboratories across the country.”

The Turkens passionately defend Hiserodt’s assistance, calling him a “saint” who fought to save the life of their 8-year-old daughter.

Robert and Dana Turken said they were outraged by the federal investigations and, in the past, expressed stinging criticism of the UCI inquiry into Hiserodt’s actions. Robert Turken, a lawyer, said Hiserodt sent the unauthorized cancer treatment to Miami only because of his pleas for help.

“I don’t like the idea of a person, who in 100 lifetimes I would never be about to thank enough, having his life ruined because he tried to help me and my daughter,” Turken said Tuesday.

He said magnetic resonance imaging, blood tests and an autopsy showed that the cell culture Hiserodt developed was aggressively destroying portions of Jennifer’s brain tumor.

Because of Hiserodt’s assistance, Jennifer lived much longer than doctors first predicted, long enough, he said, to watch fireworks with her family on the Fourth of July, 1996.

Turken said he couldn’t understand why the treatment would require FDA approval since it was a laboratory culture of his daughter’s own blood cells.

But Granger said he specifically instructed the cancer specialists in his unit not to use the experimental treatments on any patients without FDA approval.

“It was clearly understood that no human research should be conducted without the appropriate approvals, and it was the responsibility of the individuals involved to obtain the approval,” Granger said in a March 14, 1997, letter to Frances Leslie, UCI’s associate vice chancellor for research.