The first human CRISPR trial approved in the United States is finally recruiting the first patient. In the meantime trials have grown to a dozen in China, considering those revealed by the Wall Street Journal inquiry besides the NIH database (check also this npr article for further details). Over 80 Chinese patients are already receiving a CRISPR-based treatment, while US researchers cautiously plan to test the safety of their experimental therapy on a single subject, and, if everything goes right, two more patients will be treated a month later. Is the West losing its genome-editing edge to Beijing?
According to Carl June, the Penn University scientist who pioneered the studies leading to the US trial, it’s kind of like Sputnik 2.0, with China and CRISPR instead of the Soviets and the first satellite. Beijing sees genome editing as a field where it can successfully compete with the West and has a light regulatory approach to human testing. While June had to wait two years for the go-ahead, his competitors were allowed to begin in just two months. The Penn team had to persuade two federal agencies, while a single hospital committee was enough for the trial in Hangzhou. Its nine members – a bioethicist, a lawyer, some doctors and nurses, a journalist, a patient representative and a representative of public opinion – unanimously passed the application in an afternoon, according to the WSJ. Standards are also very different for consent documents and adverse events reporting. The US system is focused on the need to minimize risks, while China uppermost concern is to verify possible benefits as soon as possible, science historian Hallam Stevens said to npr.
Most Western researchers, however, believe that rushing ahead too quickly would be unwise: an accident, like the one hitting conventional gene therapy almost 20 years ago, could result in a loss of public trust and a setback for the whole sector. If this is a race, the tortoise will win, according to a countertrend comment published in New Scientist with the title “Calm down – China is not racing ahead with human CRISPR trials.” The first use of gene editing without CRISPR help, aiming to increase human resistance to Hiv, was a US accomplishment. The first effort to edit a gene to cure cancer was in the UK. The first attempt to edit cells inside the body, in vivo, was also in the US. Now we have two competing CRISPR trials in China and United States, both trying to enhance the immune system anti-tumor abilities and both targeting the same gene (PD -1) in T cells. But the Penn protocol is more sophisticated and promising than the Chinese one. And if it’s really a Sputnik remake, of course, Moscow got the first artificial satellite, but everybody knows who conquered the Moon.