[BEIJING] The maker of a traditional Chinese remedy is suing the Chinese Government for refusing to approve it for the treatment of HIV infection.
The medicine, Fufang Sanhuangsan (FFSHS), is a combination of up to 10 herbs, including skullcap, dandelion and bupleurum. It is manufactured by HSR, a company based in Kunming, in Yunnan Province. The company markets FFSHS as an alternative to conventional anti-retroviral drugs such as zidovudine and lamivadin.
The remedy has been undergoing trials since 2005, with financial support from the Ministry of Science and Technology. Some 198 HIV patients in six Beijing-based hospitals have been taking it. In late 2007, the company claimed it had satisfactorily improved patients' CD4 counts (the number of T-cells, used as a marker of patient's immunity) and reduced their HIV viral loads. The results have not been published.
But in October 2008 the State Food and Drug Administration (SFDA) refused HSR's application for a licence. It said that random blood samples from 37 of the patients in the trials had detected lamivadin, a common anti-retroviral, making it unclear whether lamivadin or the traditional remedy was the active agent.
After a failed appeal, the company is now suing the Chinese administration.
Chen Dagang, project manager at HSR, said that the remedy was the only anti-HIV medicine used, and that no lamivadin was found in blood samples taken from other patients in the trial.
"The real reason behind the SFDA's refusal is that many experts still disbelieve that traditional Chinese medicines (TCM) can really treat HIV " said Chen.
Lui Aiping, also a senior researcher at the academy, says that while some traditional medicine might be able to inhibit HIV, the results are often hard to replicate.
It could, however, supplement conventional treatment. It could also be given either during the early period of infection before doctors consider anti-retrovirals appropriate, or when anti-retrovirals are unavailable.
Separately, at the first ever WHO Congress on Traditional Medicine, held in Beijing this month (10 November), experts from more than 70 countries approved a Beijing Declaration that may help usher traditional medicines into health systems around the world.
The declaration calls on UN member states to build policies that will allow the safe and effective use of traditional medicines, encourage practitioners of Western and traditional medicines to communicate with each other, and create systems for licensing traditional practitioners.