Summary of Key Points
The team led by Qiu Zilong from Shanghai Jiao Tong University and Xinhua Hospital used an AAV (Adeno-Associated Virus) gene therapy to treat 6-year-old Xiaomei, who suffered from developmental delays caused by a CHD3 gene mutation (not life-threatening). However, the treatment resulted in her death due to side effects of the viral vector. This incident is more tragic than the Jesse gene therapy case in the United States in 1999: a 26-year-old “textbook lesson” has not been learned, known risks were ignored, the patient’s condition did not warrant a risky experiment, the results of animal toxicity tests were downplayed, and the tragedy was concealed for over a year, exposing serious flaws in medical ethics and regulation.
I. A 26-Year “Textbook Lesson” Went Unheeded – Repeating the Tragedy Is in Itself a Major Error
The death of Jesse in 1999 due to the side effects of the gene therapy viral vector is a classic negative example that should be known by all professionals in the field of gene therapy. Yet, 26 years later, the Qiu Zilong team repeated the same tragedy: both cases involved experimental gene therapy and the death of young patients from viral vector complications. This is not simply a matter of “ignorance leading to error” but a blatant disregard for basic industry standards – it’s like a teacher repeatedly warning students not to touch fire, yet they still choose to do so; the nature of this mistake is extremely serious.
II. Known Risks Were Ignored Despite Being Clear
At the time of the Jesse incident, the risks associated with gene therapy viral vectors were unknown. However, 26 years later, the dangers of AAV vectors (especially in high doses) are well-established industry knowledge. The AAV9 vector used by the Qiu team was discovered by Wilson’s laboratory, which was responsible for the Jesse case, and Wilson himself had previously warned about the safety risks of high-dose AAVs (for example, in 2018, he published research indicating that high-dose AAV9 could cause liver and neurological toxicity in animals). It’s as if someone has already stepped into a pit with a warning sign, yet they choose to jump in again.
III. Using a Non-Lethal Child for the Experiment – There Was No Need to Take Such a Risk
Jesse suffered from an OTCD metabolic disorder that could be fatal before the age of 5; although his symptoms were mild, he needed daily medication and frequent hospitalizations. In contrast, Xiaomei’s condition (developmental delays due to a CHD3 gene mutation) is usually not life-threatening, and her symptoms were very mild. Simply put, Jesse’s situation required treatment to avoid death, while in Xiaomei’s case, the treatment proved fatal – using a non-lethal child for such a high-risk experiment is completely unethical.
IV. Downplaying Animal Toxicity Test Results
Before the Xiaomei incident, tests on rhesus monkeys showed that both low and high doses of the AAV vector caused liver damage, with high doses also leading to kidney damage. The team informed the family about these results but downplayed their severity. Even more absurdly, the ethics review approved the experiment before the toxicity report was available, and the report was not even reviewed during the experiment. In comparison, during Jesse’s case, the monkeys received a dose 17 times higher than that used in Xiaomei’s experiment, yet the oversight in the review process was even more severe.
V. The Tragedy Was Concealed for Over a Year – A Complete Lack of Regulation and Transparency
After Jesse’s death, the FDA immediately halted related experiments and launched a nationwide investigation. In Xiaomei’s case, she passed away in March 2025, but the incident was only made public in July 2026 after being reported by Science magazine. During this period, the Yangpu District Health Commission in Shanghai only fined the hospital 25,000 yuan and gave a verbal warning to the responsible personnel; Qiu Zilong was not punished, and the team continued to publish papers in Nature without mentioning the death. The involved institutions only took serious action after the incident became public. The delay in regulation and lack of transparency exacerbated the impact of the tragedy and prevented the industry from reflecting on it in a timely manner.
This incident is not an “accidental mistake” but a triple disregard for medical ethics, patient life, and industry standards. If proper investigation and reforms are not carried out, it will not only undermine public trust in gene therapy but also cause more innocent patients to suffer.