The Alliance for Regenerative Medicine, an advocacy group, has issued a statement endorsing gene editing in somatic cells while deeming germline gene editing inappropriate. The statement of principles, timed to coincide with a conference on gene editing standards sponsored by the World Health Organization in Geneva this week, was prepared by a task force of 13 member companies involved in gene editing.
“Regulated, clinical validation of somatic cell-based gene editing technologies for noninherited genetic modification is, and should remain, the primary objective of the therapeutic development community,” the group states in its release.
ARM goes on to support work underway at standards bodies such as the National Institute of Standards and Technology’s Genome Editing Consortium to develop methods of addressing off-target effects of gene editing.
The ARM task force says technology has not matured to the point where editing heritable genes would be appropriate. Key safety, ethical, legal, and societal issues core to germline editing remain unresolved, it adds.
The group’s findings are in line with statements issued over the past two years by the National Academies of Science and Medicine and the Nuffield Council of Bioethics, a UK organization.
ARM’s statement of principles is intended as a response from research organizations involved in gene editing to the debate over the technique following the announcement last November by the researcher He Jiankui of twin girls born in China who are purported to be the first babies modified via gene editing.
“We wanted to be clear and to calm the discussion down,” says Sandy Macrae, CEO of Sangamo and cochair of ARM’s task force. “The events in China are very atypical, and those of us in the industry that are doing gene therapy and gene editing are very clear that we do somatic cell editing, and we just don’t think the world is ready for germline editing.”
Ben Hurlbut, a professor of biology and society at Arizona State University, applauds ARM for affirming the view on gene editing taken by the National Academies, WHO, and other organizations. “What is worrisome about statements like this, however,” Hurlbut says, “is that they can be read to imply that germline is unacceptable because the technology is not good enough yet,” and that once the technology has matured, clinical trials will be deemed appropriate.
Even if the statement leaves the door open to future germline editing, Francoise Baylis, a professor of bioethics and philosophy at Dalhousie University, says it does not indicate that ARM views the technique as inevitable. She notes that ARM points to “complex ethical issues” inherent in germline modifications. Determining the propriety of heritable editing is viewed by the group as “not just a matter of complex science,” she says.
According to ARM, 28 of its approximately 350 members, which include commercial, institutional, and academic laboratories, use somatic cell gene editing. ARM CEO Janet Lambert delivered the statement at the WHO conference in Geneva last week.