BEIJING, Feb 27, 2019 (BSS/AFP) – China has drafted new rules to supervise
biotechnology research, with fines and bans against rogue scientists after a
Chinese researcher caused a global outcry by claiming that he gene-edited
babies.
The announcement comes as He Jiankui’s controversial experiment continues
to transfix the scientific community, with researchers saying the procedure
had the potential of enhancing the learning capabilities and memory of the
babies.
He announced in November that the world’s first gene-edited babies — twin
girls — were born that same month after he altered their DNA to prevent them
from contracting HIV by deleting a certain gene under a technique known as
CRISPR.
The claim shocked scientists worldwide, raising questions about bioethics
and putting a spotlight on China’s lax oversight of scientific research.
Gene-editing for reproductive purposes is illegal in most countries.
China’s health ministry issued regulations in 2003 prohibiting gene-editing
of human embryos, though the procedure is allowed for “non-reproductive
purposes”.
The new rules unveiled by Beijing on Tuesday propose to classify
technology used for extracting genetic materials, gene editing, gene transfer
and stem cell research as “high risk”.
Health authorities under the central government would manage such
research.
The State Council, China’s cabinet, would be responsible for “the
supervision and administration of clinical research and applications
throughout the country,” according to the rules.
The new draft proposes fines of between 50,000 and 100,000 yuan ($7,500
and $15,000) for scientists or institutions that carry out research without
proper authorisation, and the government can stop the work.
Scientists can also be fined 10 to 20 times the amount of “illegal income”
earned from unauthorised research and be banned from their field of work for
six months to one year.
“If the circumstances are serious, their medical practice licence shall be
revoked and the individual shall not engage in clinical research for life,”
the rules say.
He Jiankui has been placed under police investigation, the government
ordered a halt to his research work and he was fired by his Chinese
university.
– Smarter babies? –
His experiment involved deleting a gene called CCR5, a process that could
also enhance memory and the brain’s ability to make new connections —
linking it to academic success, according to a study published last week in
the journal Cell.
“Certain aspects of cognitive function, including long term memory, could
have been enhanced by the CCR5 mutation in the twin girls,” said Alcino
Silva, a neurobiologist at the University of California, Los Angeles (UCLA).
His team first discovered how the CCR5 gene affected learning and memory
in mice in 2016. The study by Silva and others showed people who naturally
lack the CCR5 gene recover more quickly from strokes.
People missing at least one copy of the gene also seem to have better
learning abilities, it said, suggesting a possible role in everyday
intelligence.
“It is very possible that other aspects of cognitive function (of the
twins) may have also been disrupted. We simply do not know enough at this
time to be altering the genome of healthy babies,” Silva told AFP.
“There was no reason to put these two babies through an untested and
potentially very dangerous, life-altering procedure,” Silva said.
Eight volunteer couples — HIV-positive fathers and HIV-negative mothers –
– signed up for He’s trial.
A second woman became pregnant in the experiment but it is unknown if she
has given birth yet.
– Who funded it? –
Miou Zhou, a professor at the Western University of Health Sciences in
California, told AFP he was “shocked” by the controversial experiment, which
could inflame speculation about the creation of super-intelligent humans
using gene-editing technology.
“Because I have been studying CCR5 on cognitive function in mice for a long
time, I remember my first reaction was why (did) he choose CCR5 to make the
first genetically edited babies?” Zhou said.
During a human genome summit in Hong Kong last year, He Jiankui
acknowledged he knew about the potential brain effects of tinkering with the
CCR5 gene from Silva’s and Zhou’s previous research dating back to 2016.
“I saw… (Silva’s) paper, it needs more independent verification,” he
replied when asked about it during a Q&A session.
“I am against using genome editing for enhancement.”
Investigators told Xinhua that He was “pursuing personal fame” and used
“self-raised funds” for the experiment.
But a November submission by He’s team to the Chinese Clinical Trial
Registry has identified the Shenzhen Science and Technology Innovation Free
Exploration Project — a publicly-funded programme overseen by the local
government — as bankrolling the experiment.
The programme, however, denies funding He’s project.
A statement on its official WeChat social media account said it “never
sponsored” He’s experiments and that the information provided to the clinical
trial registry “was not true”.