By Shan Juan (China Daily)
Updated: 2008-04-23 08:06

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.

"Medical ethics is the top concern in a drug trial Most of the therapies would fail for terminal cancer patients. But clinical trials of the latest potential remedies, provided free, might be effective for them. At least, they can save the patients and their families from the heavy economic burden even if they don't prove efficacious," he says.

An increasing number of foreign drug and medical device companies have begun outsourcing their research and development (R&D) work in China, and clinical trials are on top of their tasks. China attracts them with its sound infrastructure, low research cost and the huge number of patients suffering from chronic and infectious diseases. Experts say the cost of drug trials in China can be as little as one-tenth of that in the US or Europe.

In the US, drug companies have a hard time trying to enroll enough people for clinical trials. But the situation is quite different in China, which has 130 million hepatitis B patients and carriers alone - a number larger than the combined populations of Britain and France. And many of such patients are poor farmers or workers.

"The US has no such pool," says Terry E. Winters, British biochemist and chairman of the Vital Therapies Inc. Besides, foreign companies' drugs and medical devices have to be tested locally in China before they can enter the country's huge market, "That boosts trial outsourcing too," he said.

Big drug companies doubled their investment in R&D to $2.2 billion in China and India, and most of the additional amount came to China. Drug companies' business is booming, and with it have increased medical disputes, including those over clinical trials. Some of these cases, like Ouyang's, end up in court, and verdicts in such cases are slow to come by, given the series of complicated medical verifications and appraisals.

Clinical trials for more than 800 new medications, including drugs and medical devices, are conducted in the country every year, according to official figures, and most of them are conducted by foreign pharmaceutical companies.

Clinical trials can indeed be a problem - not only of medical ethics, but also of proper healthcare, poverty and helpless patients' desperation. And only foolproof government regulation and socially conscious drug companies can make them beneficial to human beings.

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