He Was Child’s Last Hope, Parents Say of Researcher

When doctors told Robert and Dana Turken that their daughter’s brain tumor was untreatable and destined to be fatal, the Miami Beach couple refused to accept the dire prognosis.

Instead, the Turkens searched the country for a treatment for young Jennifer, eventually winding up at UCI Medical Center in Orange. There, they enlisted the help of UC Irvine researcher Dr. John C. Hiserodt, who had developed a potent weapon, a cell culture, that wasn’t federally approved.

After returning to Florida in mid-1996, the couple pleaded with Hiserodt to ship the cell culture to Jennifer’s doctors in Miami. He complied, according to an internal UCI inquiry a year later.

“When you’re a parent of a little girl who is going to die, who has a disease that everyone says is fatal and there is no hope, you’re going to do anything you can to help her,” Turken said Tuesday in a telephone interview. “This man compromised himself to help a little girl. He understood this was the only hope we had.”

But Jennifer’s cancer had progressed too far. She died in September 1996, a month after receiving the last dose of Hiserodt’s cell culture. She was 8 years old.

Because of his actions, Hiserodt is now under regulatory and criminal investigations by the Food and Drug Administration for allegedly shipping an unauthorized experimental drug across state lines, UCI officials confirmed this week. Hiserodt was unavailable for comment Tuesday.

News of the investigations has the Turkens fuming.

“I am truly heartsick, because he was the only one who tried to help us,” said Dana Turken, who spent most of Tuesday in tears after hearing of the doctor’s predicament. “To crucify a person like John Hiserodt is abominable.”

FDA officials said they could not confirm or deny that Hiserodt was under investigation but said federal law restricts the use of experimental drugs and treatments on patients. The restrictions are designed to protect vulnerable people from treatments that may be harmful or not effective.

Still, the FDA often approves experimental treatments for patients in dire health, even for drugs that have not been thoroughly tested and are considered risky, said Terry Toigo, the FDA’s associate commissioner for special health issues.

“If a physician wants to treat a single patient that we don’t have in a clinical trial, they can talk to us,” Toigo said. “There is a legal mechanism to do that.”

But FDA approval still is required.

The medical community, meantime, is questioning whether federal protections are adequate for human subjects of experimental treatments. A report in today’s Journal of the American Medical Assn. states that such protections have failed to keep up with today’s complex medical research.

‘Hiserodt Is a Saint,’ Parent Says of Doctor

Hiserodt took a leave of absence during the UCI inquiry and eventually resigned. Two other UCI researchers who worked with him were sanctioned.

The UCI inquiry also found that Hiserodt may have violated a federal directive banning him from participating in federally funded research. The action came after the National Institutes of Health in 1994 determined Hiserodt fabricated research data in a grant application while he was at the University of Pittsburgh Medical Center.

The Turkens said the experimental cancer treatment at UCI was their daughter’s last hope. After undergoing exhaustive regimen of chemotherapy and radiation at Duke University, Jennifer’s cancer recurred. Her doctors in North Carolina said a UCI clinical trial offered promise.

But the Turkens have only unpleasant memories of their trips to Orange County for Jennifer’s treatment. The UCI staff expressed little interest in her condition or compassion about what the little girl and her family were living through, they said. Hiserodt was an exception.

During one visit to Orange County in the spring of 1996, the Turkens became so fed up by Jennifer’s overall care they demanded she be discharged from the UCI Medical Center, deciding instead to continue her treatment in Miami.

“I don’t give a s--- about UCI, but John Hiserodt is a saint,” Robert Turken said.

The family wrote an impassioned letter to UCI in 1997 defending Hiserodt and criticizing them for questioning the treatment.

UCI spokesman Tracy Childs said he was unfamiliar with the case, and UCI Medical Center officials were unavailable for comment Tuesday.

Jennifer died on Sept. 7, 1996, losing a three-year battle with brain cancer. The Turkens said they still mourn her loss but take comfort in the knowledge they fought to the end to save her.

They said magnetic resonance imaging, blood tests and an autopsy showed that the culture was aggressively destroying portions of the tumor. They requested the autopsy hoping that the results would validate the effectiveness of the treatment and would benefit other cancer-stricken children.

Jennifer’s father was angry that UCI padlocked Hiserodt’s laboratory, ending further research.

“That’s the part that was so frustrating to us,” he said. “Beyond the horror of losing our daughter was the fact that they were on to something.”

He said Hiserodt deserves a medal for what he did, instead of having his reputation tarnished by the allegations.

The doctor’s research stemmed from the FDA-approved experimental treatment Jennifer underwent at UCI, where donor lymphocytes--white blood cells--were transplanted into her brain tumor. The foreign cells triggered a response from her own immune system to destroy the foreign cells and attacked the nearby cancer cells as well.

In effect, the procedure prompted Jennifer’s body to produce new white blood cells with the ability to kill cancerous cells and destroy her tumor. But the cancer was spreading too fast.

Hiserodt took the process one step further, cultivating those aggressive white blood cells in the laboratory, Robert Turken said. It was that substance that was shipped to Miami Children’s Hospital to be transplanted into Jennifer’s tumor, her father said.

Toigo said all experimental medical treatments, including biological derivatives, require FDA approval. But Turken said he still is dumbfounded about why FDA approval was required in the first place.

“It wasn’t a drug,” he said. “They were her own cells.”

Federal Laws Haven’t Kept Pace, Report States

Today’s JAMA report contends that federal protections for human subjects undergoing experimental treatments have failed to keep up with complex modern-day medical research. It also contends that unnecessary paperwork involved also may hinder promising drug treatments.

The report, written by doctors at the University of Pennsylvania Health System’s Center of Bioethics in Philadelphia, said that federal regulations protecting human subjects of experimental treatments have not been substantially reexamined for more than 17 years.

“Doubt has evolved as to whether the regulations currently in place adequately protect the welfare and rights of research subjects in today’s . . . research environment and whether the costs, in terms of time, bureaucracy and delay, are justified by the level of protection afforded,” the panel determined.

The article, a copy of which was released Tuesday, recommends more stringent protections for vulnerable patients, including children, and a overhaul of the federal health agencies charged with protecting research subjects.