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【社会人文】China's deadly drug problem
Nature 446, 598-599 (5 April 2007) | doi:10.1038/446598a; Published online 4 April 2007
China's deadly drug problem
The head of China's drug-safety agency is under investigation for alleged corruption. David Cyranoski looks at how the inquiry might affect the country's fast-growing pharmaceutical industry.
A corruption scandal at China's top drug-regulatory agency has led to the arrest of its former head and an investigation of unprecedented scale into drugs approved during his tenure. Some are calling the crackdown a step towards a modernized drug industry that encourages innovation. But others wonder whether anything will really change. "The government is cleaning up, but many hope it will be changed once and for all," says Wang Ming Wei, director of the National Center for Drug Screening in Shanghai. "You can't just do cosmetic surgery."
Many hope the drug industry will be changed once and for all. You can't just do cosmetic surgery.
Wang Ming Wei
The scandal centres around Zheng Xiaoyu, who was the head of the State Food and Drug Administration (SFDA) from 1998 until June 2005. Last summer, concerns mounted about the agency after poor-quality drugs resulted in some highly publicized deaths. More than ten people died across the country after being injected with the antibiotic clindamycin, which had not been sterilized properly. And 11 people in southern China died from kidney failure after receiving the drug armillarisni A, which had been manufactured with a toxic substance.
A high-level probe of the SFDA culminated in Zheng being detained in December 2006. In late January, the Chinese premier Wen Jiabao ordered an investigation into reports that Zheng had accepted bribes, and Zheng was subsequently thrown out of the Communist Party. Two of Zheng's former secretaries have also been detained. Hao Heping, who headed the department that bestowed licences to manufacture medical equipment, was sentenced to 15 years in prison for accepting money to smooth drug approvals. Cao Wenzhuang, former head of the drug-registry division, has also been detained.
Zheng's wife and son were also arrested, according to Chinese news reports. A senior executive of a foreign pharmaceutical company who did not want to be named says that they ran consulting firms whose work would help ensure a drug's approval.
China's US$13-billion pharmaceutical industry has struggled to overcome deeply rooted problems. Many drug companies in China make money not through innovation but by making different formulations of products. Statistics provided by Wang show that about half of the 'new' drugs are varieties of previously approved products. Yet large numbers of applications flood the SFDA; in 2004, for instance, China fielded some 17,000 applications for new drug approvals, compared with 167 for the US Food and Drug Administration.
At first, Zheng seemed like a reformer who was trying to modernize the country's regulatory oversight. A veteran of the drug industry, he led a merger of the state food administration and the state drug administration — which he had headed — into the SFDA in 1998. He introduced a Chinese version of Good Manufacturing Practice guidelines, which ensure that production is up to standard and that a mechanism is in place to deal with drug problems. All Chinese drug companies had to comply with the requirement by July 2004; more than a quarter closed their doors. Zheng also established new requirements that traditional Chinese medicines had to fall in line with national, rather than previously established regional, standards.
Under the new pressures, observers say, drug companies became desperate to get their products approved by SFDA officials, who were able to use their positions to push drugs through the system. "There was too much power invested in a few individuals," says Wang. Government officials seem to agree. In February, Wu Yi, one of China's vice-premiers, reportedly told members of the SFDA: "We urgently need to reform the system to remove loopholes in food and drug administration and set up an effective mechanism for clean governance." She suggested several measures that could be implemented, such as requiring that the acceptance, appraisal and approval of new drug applications are each handled by different people.
Stifling standards
But as the SFDA tries to raise standards for its drug-approval processes, some are worried that smaller companies will not be able to survive. According to one Shanghai-based researcher involved in drug development, some clinical trials now require thousands of patients rather than the hundreds needed previously. The source blames "arbitrarily high" standards that came as a reaction from "demoralized" SFDA staff. "Because of the overreaction, people without deep pockets will suffer," he says.
David Liu, vice-president of Beijing Pharmaceutical, a wholesaler for drugs and medical devices, agrees that the system is geared towards taking smaller manufacturers out of the market. But it is a good thing, he says, because most of those companies do not innovate. "It is not like the United States, where you have small companies with an entrepreneurial spirit. In China, a small company means quick in, quick out," he says.
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作者:admin@医学,生命科学 2011-03-06 05:14
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