Science is far from enabling so-called “designer” babies, but policymakers of all stripes are still rushing to urge caution on the issue.
One of several spending bills being considered in the House would prohibit the Food and Drug Administration from spending taxpayer dollars in connection with the modification of genes in a human embryo, a technique known as “gene-editing.”
The FDA isn’t doing that now anyway, and many bioethicists say that’s not even on the agency’s radar. But House Republicans added the language to the agriculture appropriations bill soon after Chinese scientists announced in April that they had become the first to edit the genes of a human embryo.
“Researchers do not yet fully understand all the possible side effects of editing the genes of a viable human embryo,” the bill says. “Editing of the human germline may involve serious and unquantifiable safety and ethical issues.”
The legislation also includes language placing more scrutiny on a related reproductive technique in which babies are created from the genetic material of three people. It would require the FDA to create a committee including religious experts to evaluate a report on the process, expected to be completed this winter by the Institute of Medicine.
If Congress approves the spending bill, which would need to take place by a Dec. 11 deadline, it wouldn’t halt any research being carried out. But it does reflect growing attention to the issue and a rare point in science where Democrats and Republicans share concerns.
The White House also has taken a firm stance against embryonic gene-editing, at least for now, in response to the research going on in China. It’s a “line that shouldn’t be crossed,” wrote John Holdren, director of the White House Office of Science and Technology Policy last spring.
“The administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time,” Holdren wrote.
Scientists distinguish between two types of gene-editing. There’s the editing of child or adult genes, which holds promise for treating diseases of the blood, such as leukemia, or improving the body’s ability to fight AIDS. And that’s where biopharmaceutical companies are focused. Sangamo BioSciences, for example, is working on gene-editing therapy for HIV.
The lesser-developed field is what’s known as germline-editing, or editing of embryo genes. The National Academy of Sciences is holding a three-day summit early next month to examine new gene-editing technologies, which it says hold great promise. But it’s also concerned about the potential of modifying the genetic makeup of future generations.
So much more precision would be needed to safely carry out germline editing that scientists say they’re not even close to a process whereby parents could actually choose parts of their child’s genetic makeup.
But the mere idea is so troubling to many policymakers that they’re taking extra safeguards to ensure scientists don’t embark too quickly on a field of research holding major ethical concerns.
At a House hearing on gene-editing in June, Rep. Lamar Smith, R-Texas, called China’s involvement in embryonic gene-editing “alarming.”
“This is an area where the United States can and should provide scientific and moral leadership,” Smith said. “We need to better understand the technology and procedures being used so that we can ensure patients are treated in the safest and most ethical manner possible.”
Concerns about gene-editing also come from activists on the Left, who worry that it could lead to some sort of classist gene-selection available to only the privileged, while those on the Right air more concerns about violating human dignity.
“There’s an interesting conjunction of progressives and conservatives on this,” said Jonathan Moreno, a medical ethics professor at the University of Pennsylvania and fellow at the left-leaning Center for American Progress.
Some bioethicists see it as a good thing that policymakers are stressing caution on the idea of germline editing. But others feel it could aggravate the public’s misperception that science is on the cusp of allowing designer babies. It’s a sexy topic that grabs people’s attention but can also make them wary of important advances in adult gene-editing, Moreno said.
“What you don’t want is for the good things that could happen to be pushed aside because people are more anxious about some of the sexy things that are out there,” he said.
Hank Greely, a bioethicist at Stanford University, feels the House language restricting germline editing is “showboating” by Congress. “FDA isn’t about to allow someone to try to use this to make babies, not without years and year (a decade?) of preclinical trials,” he wrote in an email.
Eleonore Pauwels, a bioethicist at the Wilson Center in Washington, said it’s important to educate Americans about what kind of gene-editing is possible, instead of passing laws that could unnecessarily “frighten” people.
“I don’t know whether it has to be written in the law now,” she said. “I don’t think the FDA is going to put resources into this right now. They will have to look at gene editing in adult cells first.”
