As the biotech revolution accelerates globally, the US could be getting left behind on key technological advances: namely, human genetic modification.
A Congressional ban on human germline modification has “drawn new lines in the sand” on gene editing legislation, argues a paper published today in Science by Harvard law and bioethics professor I. Glenn Cohen and leading biologist Eli Adashi of Brown University. They say that without a course correction, “the United States is ceding its leadership in this arena to other nations.”
Germline gene modification is the act of making heritable changes to early stage human embryos or sex cells that can be passed down to the next generation, and it will be banned in the US. This is different from somatic gene editing, which is editing cells of humans that have already been born.
The ban, added by the House of Representatives as a rider to the fiscal year 2016 budget, could have far-reaching implications if it continues to be annually renewed, according to the authors.
It “undermines ongoing conversations on the possibility of human germline modification” and also affects “ongoing efforts by the FDA [Food and Drug Administration] to review the prevention of mitochondrial DNA diseases,” including some kinds of hearing and vision impairments, among other serious illnesses that tend to develop in young children.
“This latest congressional intervention appears premature… in that the germline modification debate is barely getting underway,” write the authors.
“The prospect of a telling a parent that they won’t have access to these therapies is morally untenable”
And the debate may be paused indefinitely, should the rider continue to be renewed in the budget in coming years.
“We are on the cusp of being able to do [gene editing] safely, and the prospect of a telling a parent that they won’t have access to these therapies is morally untenable,” said bioethicist James Hughes, executive director of the Institute for Ethics and Emerging Technologies. “A ban doesn’t make sense the way a moratorium does.”
In the UK, which some in the field see as being more liberal than the US in gene editing legislation, MRT was approved by both houses of Parliament last year, following a robust period of investigation, public debate, and multiple rounds of parliamentary review.
Clinical trials of human embryos that have “three parents” are due to begin, pending a final round of approvals by the Human Fertilisation and Embryology Authority (HFEA), the UK’s regulatory agency for reproductive medicine.
Despite an independent bioethics committee finding that the FDA should approve clinical trials for MRT, if only with male embryos (which would not be able to pass on a heritable mitochondrial illness, should something go wrong), the FDA chose to reject the idea.
“The reality is in the United States, nobody was ready to start a human [clinical] trial for MRT,” said Alta Charo, one of the leading minds in American bioethics and medical law and co-chair of a committee studying gene editing at the National Academies of Sciences, Engineering and Medicine. “The more difficult question to answer is how this affects long-term prospects if this position rolls into the next round of legislation.”
A spokesperson for the FDA said that the agency can’t speculate on future provisions, and reiterated to Motherboard that human subject research utilizing genetic modification is off the table for now.
Charo said any pushback against the Congressional ban wouldn’t necessarily come from the science community, but that legislators may hear displeasure from patient advocacy groups
Congress began looking into gene editing last year with hearings led by House Science, Space and Technology committee Chair Lamar Smith (R-TX), who believes that the US should proceed with severe caution when it comes to genetically altering embryos with heritable changes, even if it means putting off curing diseases. Rep. Smith was also in favor of the voluntary moratorium on use of the gene editing technology CRISPR-Cas9, undertaken by scientists in March 2015.
This year’s Congressional ban takes the cautious moratorium a step further by enacting a law, as opposed to calling on scientists to self-censor and stop short of the clinic, and supersedes the global conversation around the issue, led by the National Academies.
“Most of the scientific community members have been clear: The science and ethics of this new technology must be resolved in order to prevent dangerous abuses and unintended consequences,” said Smith, who also insisted that the US should “provide scientific and moral leadership” when it comes to gene editing.
It should be noted that Smith, chair of a congressional science subcommittee, is a known climate change denier.
Charo said any pushback against the Congressional ban wouldn’t necessarily come from the science community, but that legislators may hear displeasure from patient advocacy groups, despite the fairly small number of people who have a vested interest in using this kind of technology.
Up to 4,000 children a year are diagnosed with some form of mitochondrial disorder, according to non-profit organization the United Mitochondrial Disease Foundation.
It could be possible that the waiting game Congress is playing is a blessing in disguise for the research, however. The legal systems and contexts of science funding, access to healthcare, regulatory bureaucracy and comfort with human embryo experimentation is vastly different between the US and other countries that are moving more swiftly, such as the UK.
One only needs to look at a recent Pew study that found the majority of Americans are uneasy with gene editing, and that only 28 percent believe it is morally acceptable to edit genes to give otherwise healthy children a reduced risk of disease. Religion figured heavily in respondents’ reasoning, researchers found, which isn’t always a concern at the forefront of the scientific community.
“For the people in bioethics, in science, we tend to be secular academics,” said Hughes. “It’s sometimes a challenge to factor in the spirituality of the general public.”
Until the anxiety eases and the public begins to become more educated on the issues around various forms of gene editing, perhaps not rushing to the clinic is the right thing for American science.