MONTEREY, California - In September 1999, Paul Gelsinger’s 18-year-old son, Jesse, died during a gene-therapy experiment researchers told him was safe.

The head of the trial, James Wilson, stepped down from his post at the University of Pennsylvania and has been banned by the Food and Drug Administration from participating in any human research. But in the 2-1/2 years since his boy’s death, Gelsinger has seen few changes in the protections afforded human research subjects.

“The informed consent process needs to be more open,” said Dean Hamer, chief of the gene structure and regulation section of the National Cancer Institute, referring to the process by which study volunteers are told about its risks and benefits. “The drug company goes to the FDA and says we’re going to perform a clinical trial. How it’s actually done is hidden. The drug company tests it and gives you a summary of the research. That’s not good.”

On Thursday, Hamer and Gelsinger spoke on a gene-therapy panel at the Future of Life conference here. The issues raised by the Gelsinger case, however, cover all human subject experimentation. “Jesse’s case far transcends gene therapy,” Gelsinger said.

Gelsinger’s son Jesse had a rare liver disease called ornithine transcarbamylase disorder, but unlike other subjects he didn’t stand to benefit from the gene-therapy procedure. He volunteered because researchers at the University of Pennsylvania told him it would further science. Some day, they said, the results might help cure sick babies.

But Jesse died, and his parents were left wondering how a purportedly safe experiment could have such deadly results. After some investigation, the Gelsingers found that the study was never as safe as Penn researchers led them to believe. They also discovered that Wilson, the head researcher, had a financial interest in the gene therapy’s success. That’s when they concluded there was something very wrong with the clinical trial process.

Gelsinger sued Penn and settled out of court shortly after his son’s death. But he’s not giving up on his push to make sure people know what they’re getting into in every clinical trial.

“I’m not allowed to discuss the terms of the settlement, but I refuse to be quiet about the issues surrounding what happened,” Gelsinger said. “The system failed my son at every level.”

Gelsinger has helped draft a bill sponsored by Sen. Ted Kennedy (D-Mass.) that would require more oversight for human subjects in clinical trials. But it hasn’t been introduced to Congress, Gelsinger said, because it hasn’t gotten the support it needs from Republicans.

“To that I give the usual answer: Follow the money,” Gelsinger said.

He believes the Republican administration is more concerned about the interests of biotech and pharmaceutical companies, and that they’re cool to any regulation that would make it more difficult to release new drugs.

Ironically, a nemesis of Gelsinger’s agrees.

“The current administration doesn’t actually care,” said Art Caplan, director of the Center for Bioethics at the University of Pennsylvania. “It’s not a priority for them. They’re not going to reform, fix or change anything.”

Gelsinger criticized Caplan for not providing adequate ethical guidance to Wilson, who was in charge of the gene-therapy trial that killed Jesse. Wilson had a large financial stake in a gene-therapy company linked with the trial in which Jesse participated.

But it’s not the job of in-house ethicists to guide university (or any other) researchers, Caplan said. The FDA requires that an institutional review board be appointed for that purpose.

The way such boards function doesn’t cut it, Caplan said, and he’s feeling his share of cynicism that their role hasn’t changed since the two gene-therapy deaths.

“In my view, the biggest problem is that the IRB spends a lot of time in a room, making sure the penmanship is right on the informed consent form,” Caplan said. “No one ever goes to check on what the researchers are doing once the research starts.”

Michael Werner, vice president of bioethics for the Biotechnology Industry Organization, agrees that change is needed.

He did note one positive development: the establishment of an organization called the Association for the Accreditation of Human Research Protection Programs, which gives investigators a stamp of approval for responsible treatment of human subjects.

“It’s a positive trend, but they’re just getting started,” Werner said. “We’ve definitely not seen sweeping changes.”