Profs discuss ethics of gene therapy field

The topic has taken on new importance after a patient's death at Penn. When Arthur Caplan and Stephen Eck agreed to give a talk on the ethical aspects of gene therapy, they knew they were tackling a runaway train. Yesterday's Penn Humanities Forum-sponsored meeting in Logan Hall only affirmed how quickly gene therapy has erupted as a hotly contested topic in the public -- and scientific -- eye. Caplan, director of Penn's Center for Bioethics, and Eck, co-director of cancer gene therapy programs at the Institute for Human Gene Therapy and the Penn Cancer Center, were on hand to discuss whether gene therapy will re-engineer human nature. But the discussion evolved into a debate soon after it began. "I have the enviable task of raising ethical questions about genetics," Caplan joked as he stepped to the podium. "So I'm going to talk for a week." With the recent U.S. Food and Drug Administration ban on Penn gene therapy research and allegations of negligence by IHGT researchers conducting gene therapy trials, Caplan explained, the ethical aspect of the experimental field has been thrust into the national spotlight. IHGT Director James M. Wilson, who led the gene therapy trial that drew fire from the FDA after an 18-year-old subject died following experimentation in September, was originally scheduled to talk on the panel, but withdrew. Caplan recognized the medical potential of gene therapy, pointing to the Human Genome Project, which aims to have the entire human genetic code mapped out by 2003. But he said he wondered if the field has progressed too fast too quickly. Eck, a professor of Hematology and Oncology at Penn's School of Medicine, agreed that gene therapy has moved quickly since the first clinical trials were performed in 1990, and he admitted there have been few cases of successful treatments. "Unquestionably, most of the patients? derive no benefit from the clinical trial," Eck said. The true value of trials, he noted, is garnered by investigators, researchers and scientists. But Eck quickly dismissed those who criticize researchers for not producing cures. "Most of the therapies we offer are not cures," he explained. "Insulin is not a cure. Chemotherapy is not a cure." But he pointed to several patients who have been helped, particularly cancer patients, as evidence that gene therapy has the potential to work. "There are a handful of patients who are clearly happy [with gene therapy]," Eck said. But chief among Caplan's concerns are the risks to patients enrolled in clinical trials and poor oversight by the government and the researchers of those trials. "The monitoring of human subjects? is very poor," he explained. "We don't do a good job communicating." Despite his concerns -- and the recent negative media attention -- Caplan predicted that gene therapy will continue. "The question is not how should we, but how will we," he said.

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