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Gene Edit Summit Leaders Stop Shy Of Call To Ban Germline Changes

Xconomy National — 

No call for a ban. No moratorium. But the scientists and ethicists who convened this week’s once-in-a-generation summit in Washington, DC, say that the practice of editing human DNA in a way that can be passed to future generations is “irresponsible” until there’s a body of evidence that it is safe, that it works, and that there is broad societal consensus to move forward with it.

The meeting convened scientists from around the world to describe revolutionary new techniques to change and replace people’s DNA. Lawyers, ethicists, patient advocates, and journalists also joined the mix. The resulting discussions were at certain times dramatic and heated, while at other times veered into the weeds of organizational standards-setting and international bureaucratic jargon.

It was all spurred by the rapid advance of gene editing tools, in particular a system known as CRISPR-Cas9, that act as molecular scissors deep with cells to snip out and replace faulty genes. These tools are far from perfect. There is only one instance of a therapy tested in humans so far—a program to give people with HIV a modified set of immune cells that can’t be infected by the virus.

But gene editing is advancing so quickly that fears of scientific overreach, with human and environmental consequences, prompted the international meeting, the likes of which haven’t been seen since the 1975 meeting in California to discuss the advent of genetic engineering.

The chair of the summit’s committee, Nobel Prize-winning biologist David Baltimore, read the committee’s statement at the close of the three-day meeting today. He was clear that the committee declined to use the words “ban” or “moratorium” for practical uses of human germline editing—changing the DNA in eggs, sperm, and embryos —whether it’s to treat disease, or to engineer people with desirable traits that are more about intelligence or appearance rather than health.

It’s the second time that a group of scientists involving Baltimore has avoided calling for an outright ban or pause. In a letter published in March that helped lay the groundwork for this week’s summit, Baltimore and 17 others wrote that attempts to modify the human germline for clinical applications— which in effect means experiments with human beings— should be “strongly discourage[d].”

Some of Baltimore’s co-authors, including Jennifer Doudna of the University of California, Berkeley, George Daley of Harvard University, and Paul Berg of Stanford University, were on the summit planning committee.

Although there was no official call for a ban or pause, the strong language dissuading clinical practice ran counter to an emotional theme that ran through the meeting: people with incurable diseases, or who have children with incurable diseases, asking for more urgency. In a dramatic moment on the first day, a parent of a newborn who died of a genetic disease after six days of seizures, told a panel of scientists to “just frickin’ do it.” (Antonio Regalado of MIT Technology Review was at the summit and talked to other families who expressed similar sentiments.)

The committee also said that basic research in human germline editing should be allowed, as long as the scientists involved were following their own local laws and regulations. In a Q&A session, an audience member asked Baltimore specifically if the work Chinese scientists published earlier this year, modifying “non-viable” human embryos—ones that cannot lead to a live birth—conformed to the committee’s guidelines.

“I believe that work was done following the norms and guidelines in China,” said Baltimore. “Therefore it conforms to our statement. It should have been published, and it was published. I’m supportive of that personally and I think it conforms to our dictates.”

On Wednesday, Philip Campbell, the editor in chief of the scientific journal Nature, told the gathering that his group has already rejected papers related to human germline editing because of what he called “technical inadequacies” or a lack of compliance with local regulations. (Or both.)

In his closing session, Baltimore said he was unaware of papers on human germline modification, published or unpublished. Beyond the Chinese experiment with non-viable embryos that caused a stir in April, he said he did not know of other experiments that had not been published.

Laws regulating human germline editing vary wildly from country to country. The committee called for tighter coordination between countries in crafting legislation, coming down on the side of internationalism, as many other participants did during the second day of the summit. Indira Nath of the All India Institute of Medical Sciences said “harmonization” of international rules would discourage practices such as medical and reproductive tourism. But dissenters said a variety of national rules would provide diversity and allow countries to learn from each other. “Let’s not be so quick to harmonize,” said Barbara Evans of the University of Houston Law Center.

Now that the summit has wrapped up, a committee convened by the U.S. National Academies will begin work on a comprehensive report on human gene editing that Baltimore said should be available by the end of 2016. He also said an ongoing series of public meetings and discussions will also ensue. Where those meetings are held, what their structure will be, and who participates has yet to be determined.

Baltimore also helped convene the Asilomar meeting 40 years ago. When asked to compare the gene editing summit to Asilomar, which paved the way for the use of recombinant DNA and the birth of the biotech industry, he said science shared across the globe has ramifications well beyond the laboratory. “The world is so much more international today,” he said. “The issues here are so much more ethical—moral issues rather than purely scientific issues. So we have a very different perspective. And a different outcome.”

Scissors photo courtesy Ivydawned via Creative Commons license.