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(China Daily)
Updated: 2008-04-23 09:44

Also, Ouyang's condition was serious, and the doctors had diagnosed that he had been suffering from the life-threatening hepatocirrhosis, and the only known cure was a liver transplant. "It was natural for the hospital to have recommended the therapy to prolong his life so he could get a donor liver," the lawyer said.

A Beijing Youth Daily report on June 19, 2007, quoted hospital Vice-President Duan Zhongping, who also heads the institution's Artificial Liver Treatment & Training Center, as having said that before putting Ouyang on the ELAD, the doctors had tried it on 28 other patients and none had died.

Vital Therapies Inc announced on Jan 4, 2007, that it had received positive response for its clinical trials on the first 45 patients at Beijing You'an and 302 Military hospitals. "Our center has treated a large number of patients with other mechanical and bio-artificial liver therapies, and although the data for ELAD are preliminary, none has looked more promising than ELAD to impact a patient's long-term survival from a single treatment," Duan said in the announcement.

Ouyang's case does not seem to have changed the course of ELAD treatment, for the center has said it would continue with the trials till 90 consenting patients undergo the therapy. The center insists, too, that no significant harmful effects have been attributed to the ELAD, and has not posted any details of Ouyang's case. "The ELAD trials in our hospital have been approved and commissioned by China's State Food and Drug Administration (SFDA), which is authorized to approve and oversee clinical trials in the country," Duan said. But according to the paper, SFDA's Medical Device Department official Hu Xueyan denied that Duan had said so.

Other experts too do not agree with Duan. "It's unethical to conduct clinical trials in China without the SFDA's approval," says Qiu Zongren of Asian Ethics Committee, which helps oversee such schemes. "Trial patients should be well informed of potential hazards and effects of the tests."

"Some foreign pharmaceutical companies and domestic medical institutions just take advantage of regulatory loopholes to conduct clinical trials for their products on innocent Chinese patients because the cost involved (in China) is very low," said SFDA Deputy Director Zhang Jingli said at a workshop organized by the administration in Beijing early this month. To plug such loopholes, he said the agency will issue a sound set of laws and regulations on medical device management.

Duan has a supporter in breast cancer specialist Jiang Zefei, of Beijing-based Military 307 Hospital, though. Jiang says global drug trials have given Chinese patients a new hope, especially because many of them are poor. It is not rare for poor patients to forego treatment because of the high costs involved and the "not-so-perfect" public healthcare system in China.

"Since 1997, hundreds of my critically ill patients have participated in trials for different drugs to combat breast cancer," Jiang says. "Nearly all of them, I should say, have benefited from the trials." Given the strict regulations on clinical trials, sudden field inspections by the drug watchdog and the self-discipline practiced by the hospital, there has been no medical dispute over any of "my department's trials", he says.

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