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The Center for Genetics and Society called today for increased scrutiny, transparency, and accountability for gene therapy experiments. The call comes in the wake of last week's death of a participant in a clinical trial of gene transfer for arthritis.
The recent death, in a study sponsored by Seattle-based Targeted Genetics Corporation, raises many questions and concerns, some of which have plagued the gene transfer field since its inception more than 15 years ago. In hundreds of clinical trials over that period there have been no unqualified successes, hundreds of serious adverse reactions, and some deaths.
"Given the record of significant risks and very little benefit after years of experimentation, tests of gene transfer should be limited to people who suffer from serious conditions for which there are no acceptable alternative treatments," said Marcy Darnovsky, the Center's Associate Executive Director.
Investigations following the death in 1999 of 18-year-old Jesse Gelsinger in a gene transfer clinical trial revealed serious ethical breaches and regulatory failures. An assessment is urgently needed to determine whether any similar lapses have occurred in the Targeted Genetics Corporation trial.
"Did the company follow the rules?" asked Dr. Darnovsky. "Did the FDA and the institutional review boards do their jobs?"
Such an evaluation will be made more difficult by changes in the rules governing human genetic experimentation that were implemented more than a decade ago. Access to information that had previously been publicly available was blocked, and the regulatory process was "streamlined" at the behest of industry.
"The new regulations represent a serious loss of transparency and accountability," said Osagie Obasogie, director of the CGS Program in Law and Bioethics. "We need more safeguards for research subjects and more public transparency. Instead, there is less."
CGS calls on the FDA to make available complete information about the Targeted Genetics arthritis study, including full details about the oversight provided by the FDA, the company, and the institutional review boards involved; and about the informed consent process.
"Were the participants fully informed of the risks involved? Were they told clearly that they could expect no benefits in an early-stage trial such as this one?" asked Obasogie.
The sponsorship of the arthritis study by Targeted Genetics raises additional questions. It acquired the company involved with the study in which Jesse Gelsinger died in 2000. "Targeted Genetics has an aggressive business plan and is already talking up its new arthritis treatment. Have the expectations of the company's funders and shareholders created incentives for taking ethical short cuts?" Obasogie asked.
"The precedents set in the investigation of this tragedy will have ramifications beyond the gene transfer field," Dr. Darnovsky said. "The quality of oversight and protection offered to human subjects will affect the safety of experiments with new drugs, new medical devices, and novel medical approaches such as stem cell treatments."
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The Center for Genetics and Society is a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of the new human genetic and reproductive technologies. It supports women's health and reproductive rights, including the right to terminate an unwanted pregnancy.
Contact:
Osagie Obasogie
510-625-0819 x310