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Pharma cGMP Whistleblowers in China Vindicated by Recent Government Move
...But they suffer greatly for their pains (enduring lengthy prison sentences)Â and have trouble finding employment.Â More on the Chinese government's crackdown on corruption and drug safetyÂ and its decision to sentence former SFDA chief to death fromÂ a fine LA Times article by Mark Magnier and Yin Lijin.Â
China could be a vast new frontier forÂ pharma's "whistleblower avenger" Peter Rost (although the language barrier might pose some initial challenges). An excerpt from the LA Times article looks at twoÂ brave soulsÂ who spoke out against corrupt government practices.
....Even as China has promised to redouble its efforts to tackle potentially life-threatening cases of bribery and malfeasance in the food and pharmaceutical industries, its record is not very good on protecting or even listening to whistle-blowers.Last year, Zhang Zhijian, a former employee of the Kangliyuan Pharmaceutical Co. in China's southern island province of Hainan, reposted an essay on an Internet chat room that discussed the "unnatural relationship" between his company and regulators. He said he didn't know the original author when it was posted from his company computer.Local authorities with strong ties to the company traced it to him, he said, and he was detained for almost eight months on charges of "damaging the company's reputation."He was released only after Kangliyuan appeared on a list of companies from which Zheng had received bribes.
According to the reposted essay and other reports, Kangliyuan executives bought a house in Hangzhou for Zheng to use after he retired, and lavished gifts and spent hundreds of thousands of dollars on top regulators.
Kangliyuan reportedly received approval for 120 drugs in 2005, nearly the annual total of all U.S. Food and Drug Administration approvals.
Companies that want to sell drugs in China are required to have a "Good Manufacturing Practices" certificate from the government, but many private companies can't meet the standards, Zhang said in a telephone interview, so a common practice is to bribe officials.
Another tactic for substandard companies is to learn from officials when annual and periodic "surprise" inspections will be conducted.
Since being released from detention in February, Zhang, the former Kangliyuan employee, has applied for jobs at several other pharmaceutical companies. He said each one asked him whether he would do the same thing if he saw similar problems in their company, suggesting that these practices are widespread.
"I've had interviews with over 10 companies," he added. "But no job offers. I need a job."
Zhou Huanxi, 48, said she had a similar experience. In 2001, she told regulators that her company, Hangzhou Aoyi Baoling Pharmaceutical, was replacing expensive ingredients with inert and largely worthless substitutes in medicine meant to bolster pregnant women's health.
Although she reported her findings anonymously, her telephone number was traced and reported to the police. She was sentenced to three years in prison on what she says were trumped-up charges of trying to extort the company with harmful information. The company was let off with a slap on the wrist, she said, and since then, the company's technical supervisor has been honored by the government as a model worker.
"It's not surprising that these ingredients get exported, given all the problems in China," Zhou said. "It's sheer greed. And what's the use of the state food and drug agency? They claim to investigate, but they actually help the companies they claim to investigate."