Ingrid Hein

October 31, 2016

FLORENCE, Italy — With scientists on the verge of being able to manipulate genes before birth, questions about when it is ethical to use available technology and which risks are acceptable when editing the genome are being debated.

"The question is whether we, as a society, should go down this road," said George Daley, MD, PhD, from Boston Children's Hospital in Massachusetts.

And if we do go down this road, do we do so only to treat disease, or should we "allow it to be used in other ways, such as creating individuals with specific traits?" he asked the audience during the closing session here at the European Society of Gene and Cell Therapy 2016 Annual Congress.

Scientists first tried to tackle ethical questions surrounding gene manipulation in 1975 (Nature. 2008;455:290-291), when the Asilomar Conference on Recombinant DNA was convened to look at what it means to alter individual traits. At the time, though, the technology was too immature for scientists to really tackle these questions, Dr Daley explained.

But "that time has come," he said.

The possibility for mistakes is also a huge concern, and there are still questions about the ability to assess a mutated embryo. "If a mosaic creeps in, you could be misled if you don't detect one of the edited or one of the unedited blastomeres," he said.

And the problem of off-target edits continues to plague scientists, Dr Daley added.

Policymakers and regulators must take into account local cultural and religious sensitivities, which sometimes dangerously overlap. Dr Bernard Baertschi

The question of acceptable risk related to genome editing is not a scientific question but a "policy and normative" question, said Bernard Baertschi, PhD, from the Institute for Biomedical Ethics at the Geneva University Medical School in Switzerland.

"Policymakers and regulators must take into account local cultural and religious sensitivities, which sometimes dangerously overlap," he explained. "And often nationalistic considerations come into play, such as commercial interests, or even nationalistic prestige factors."

"It's complicated," said Dr Baertschi.

"We have to think creatively about institutional and political channels and the way we can master this technology for the good of the people in a world that is already plagued by increased levels of injustice," said Giuseppe Testa, PhD, MD, from the University of Milan, Italy.

Science and Social Justice

"There's a widening gap in wealth distribution," Dr Testa pointed out. "This technology has the possibility of writing further levels of justice into DNA. We need to have very thorough and deep discussions about what kind of society we want to foster."

We want to "accompany this technology, hopefully in the driver's seat, rather than being driven by developments where we don't have a say," he explained.

Dr Testa strongly advocated for more public discourse and input. "It's not a good idea to try to deflate these concerns or to push back the discussions," he told Medscape Medical News. "Science gains and maintains its fundamental role in society when it maintains trust."

"Actually, I don't find any new arguments in the debate," said Annelien Bredenoord, PhD, from University Medical Center Utrecht in the Netherlands, who is chair of the ethics committee for the International Society for Stem Cell Research.

These arguments have long been debated in relation to in vitro fertilization, she pointed out.

Some people might argue, for instance, that the mere process is "unnatural," or that discarding embryos determined during the process to be defective, rather than modifying them, ignores the rights of the unborn child.

"And let's not forget mitochondrial gene therapy," she said, referring to the news of a baby born with the help of spindle nuclear transfer. "The UK parliament approves of it."

There are legitimate worries about how this technology ends up getting used. Dr George Daley

"What you're hearing are reports from scientific and ethical leaders who are involved in thinking through this issue in a legitimate way," said Dr Daley.

"We can be as thorough in safety assessments as possible, but we can't eliminate all risks. There are legitimate worries about how this technology ends up getting used," he pointed out.

Still, he noted, "this community is good at managing the risks."

The debate wrapped up with a strong call for professional societies to create clear guidelines and policies related to ethical concerns, in part to distance themselves from rogue research that might be performed without ethical responsibility. Scientists fear that the unethical uses of technology could lead to potential moratoriums on their research, which could prevent advances that could help treat diseases.

"It's really remarkable to have experienced the last few days of this conference and to see how far we've come in the 40 years we've been able to splice genes and make a difference," said Dr Daley. "We are curing patients, and that is extremely satisfying."

Dr Daley, Dr Baertschi, Dr Testa, and Dr Bredenoord have disclosed no relevant financial relationships.

European Society of Gene and Cell Therapy (ESGCT) 2016 Annual Congress. Presented October 21, 2016.

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