© Julia Koblitz via Unsplash
A leading Chinese medical university, Shanghai Jiaotong University School of Medicine, is investigating the death of a young girl in an experimental gene-editing trial conducted last year at its affiliated Xinhua Hospital and led by a prominent expert, Qiu Zilong.
According to a joint report by Science and Retraction Watch, the parents paid approximately 750,000 euros for the development of the treatment for their daughter, who suffered from the rare Snijders-Blok-Campeau syndrome, CNN reports. The parents claim that doctors did not warn them of the risk of death and that they were assured that “no safety catastrophes” would occur.
The hospital’s ethics committee concluded that the death was “definitely related” to the treatment, but the sanctions were limited: a small fine for the hospital and verbal counseling for a doctor. The outcome was not made public, while related research was published in Nature without any mention of the human trial or the death. After the parents discovered this earlier this year, they demanded an investigation and the retraction of the article. The university refused the retraction, but Nature has since added an editorial note and says it is investigating the manuscript.
The case has sparked outrage and concern in China over ethical lapses in the rapidly growing biotech sector, particularly since it involves established scientists at a prestigious university.
Experts point to structural risks in China’s “dual-track” system, in which investigator-initiated trials are subject to less oversight, and hope that recent new national regulations for advanced therapies will enforce greater transparency, safety, and accountability. However, there are fears that the scandal could lead to either a hasty tightening of regulations that stifles scientific progress or persistent regulatory shortcomings that undermine China’s position as a superpower in the biotech sector.
Gene editing is an emerging form of gene therapy, CNN reports, that aims to modify DNA or RNA sequences to repair or remove defective genes that cause various diseases in children and adults. These changes are not passed on to future generations.
Picture: © Julia Koblitz via Unsplash - Illustrative image