Authorities in China have warned that a batch of blood plasma produced by a large, state-owned biotech firm has been contaminated with "traces" of HIV.
A batch of intravenous immunoglobulin manufactured by state-owned Shanghai Xinxing Pharmaceutical has been ordered suspended with immediate effect after tests showed traces of HIV in samples, the National Health Commission (NHC) said in a communique on its website.
The batch of immunoglobulin, which is used as a way of delivering immune therapy to patients through plasma, consisted of more than 12,000 50ml bottles of plasma with an expiration date of June 2021, the NHC said.
"The problem batch of treatments should be immediately suspended, held under seal and patients effectively monitored," it said.
"Experts believe that the risk of HIV infection in patients using the drug is very low," it said. "[However, we have] organized a follow-up monitoring program for patients using the treatments."
Hospitals are advised to report any current stocks of the treatment to public health officials.
An article in the Beijing News newspaper said 10 hospitals had reported back by Tuesday, saying they had yet to find any patients who had contracted HIV.
Shanghai Xinxing is controlled by Chinese pharmaceutical giant Meheco Group, which is in turn owned by the state-owned China General Technology Group.
Immunoglobulin injections are generally extracted from plasma donated by blood donors.
Wang Yuedan, deputy director of the Department of Immunology at Peking University School of Medicine, believes that the nature of the incident is serious and involves violations of medical safety procedures.
"I think this definitely involves a violation of national regulations," Wang told RFA. "HIV antibodies should be detected during the production of plasma, so there must be problems with detection during the production process."
"This could be down to human error or technical reasons," he said.
Concerns about safety, effectiveness
Ren Ruihong, former head of the medical assistance department at the Chinese Red Cross, said hospitals had canceled some immunoglobulin treatments before the government went public with the news.
"A lot of the children I see have had transplants, and some have leukemia," Ren said. "They use [immunoglobulin] especially for kids who have had transplants and chemotherapy."
"But last week, there was a pediatrician who wouldn't let them have this treatment, and I later found out it was because of this," Ren said.
Ren said doctors had been unwilling to let parents know which batch numbers their children had been treated with.
Yu Zhong, a patient with hemophilia in the southeastern province of Sichuan, said they were very worried by the report.
"As a patient with hemophilia, I am a long-term user of blood products, so we are very concerned about safety and effectiveness [of these products]," Yu said.
Beijing resident Guan Tao, who also has a diagnosis of hemophilia, said there is very little patients can do to mitigate harm from such scandals, however.
"As a patient, you can only rely on the national security system to do better and stop this sort of thing from happening," Guan said.
But he said not getting his treatments isn't an option.
"That would be a bit like not eating because you're worried about getting diarrhea," he said.
A string of health scandals
The incident is the latest in a string of public health scandals involving tainted medical products.
Last month, reports emerged that 145 children in eastern China’s Jiangsu province were treated with expired polio vaccines, sparking protests from parents and an investigation of 17 officials.
Last year, the ruling Chinese Communist Party fired the head of the Center for Disease Control and Prevention (CDC) in the eastern province of Shandong "because of a case of substandard vaccines," the party's disciplinary arm announced.
Seven other Shandong officials have also been held accountable in the case, with five of them dismissed, including the deputy head of the Shandong Health and Family Planning Commission and the deputy head of the Food and Drug Administration, the China Daily newspaper reported.
The faulty vaccines were produced by Changchun Changsheng Biotech, where an unfolding scandal has seen the sacking of dozens of top officials and company executives.
Reported by Lau Siu-fung and Wong Siu-san for RFA's Cantonese Service, and by Gao Feng for the Mandarin Service. Translated and edited by Luisetta Mudie.