China's drug industry clinical trial data falsified

A government investigation in China has found that the result of 80% of the country's clinical trials are fabricated, according to a report.

The investigation, which took place over a year, examined data from 1,622 clinical trials of pharmaceutical drugs which were awaiting approval by the country's regulator for mass production, and found that there was no basis for the results recorded.

China's food and drug regulator, the State Food and Drug Administration (SFDA) apparently said in its report, that the scandal had occurred as a result of "breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff".

The report conducted by the SFDA detailed that the data gathered during trials was incomplete, untraceable or did not meet regulatory requirements for analysis.

The newspaper in which the story was initially reported – the Economic Information Daily – apparently also suggested that companies were suspected of having deliberately concealed evidence of the side-effects of drugs.

However, industry insiders told the newspaper they were not surprised by the findings, citing issues with China's generic drug industry.

Regulatory guidelines do exist for clinical trials in China, in fact the review and approval guidelines for drug registration in China were updated last year. But healthcare professional Luo Liang told RFA that the issue was that complying with the regulations would mean pharmaceutical companies would struggle to make a profit.

"The domestic market for Western pharmaceuticals in China is either confined to very straightforward generic products that have been around for a long time… or revolves around joint-venture pharmaceutical manufacture with foreign companies," Luo said. "Either that, or Chinese pharmaceutical factories get hold of the formula for certain drugs whose patents have expired. There are no new drugs in development in the same way that there are overseas."