Govt stresses ethics and efficiency in drug tests

Stricter rules

Last month, a woman from Wuhan, Hubei province, who had an irregular heartbeat and psychosis, was rushed to the intensive care unit at Wuhan Puren Hospital. Local media reported she had overdosed on a variant of chloroquine phosphate, a commercially available antimalarial drug currently being tested for efficacy against the coronavirus.

The woman took hydroxychloroquine sulfate, which is also being tested for use against the virus.

Neither she nor her family members had been infected, but she bought the drug on the internet and took it as a preventive measure. She has recovered, but requires constant monitoring.

Huang Haidong, director of emergency care at the hospital, told local media that the epidemic has put people on edge. That means some will try medications that have been reported to have an inhibitory effect on the virus in lab or animal tests, but have not received confirmation of efficacy in clinical trials.

Wu, from the ministry, said most of the drugs currently under trial are commercially available, so their safety is generally guaranteed. Testing such drugs to treat new epidemics allows scientists to skip several time-consuming stages in clinical trials, meaning patients can receive effective treatments sooner.

He stressed that only hospitals designated to treat the disease are allowed to conduct clinical trials, including makeshift hospitals in Wuhan. Moreover, a senior expert, who can formulate detailed experiments and risk-management plans, must be in charge of such trials.

All trials are also subject to ethical inspections, and the findings of the tests will be announced via official government channels, he added.

Yan Jiangying, deputy director of the National Medical Products Administration, told a media briefing last month that the government has accelerated the approval procedures for drugs and clinical tests with dedicated expert teams, and also streamlined the application process. However, safety and efficacy remain paramount prerequisites.

The administration has dispatched 13 inspection teams to work with local authorities to monitor drug production and clinical trials, and to report developments to the authorities, she said.