80% of Chinese Trial Data ‘Fabricated’: SFDA Report
China’s State Food and Drug Administration (SFDA) says that more than 80% of clinical data from clinical trials in that country are “fabricated.” Radio Free Asia (RFA) reports that Chinese state media say that a one-year SFDA study found “breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents, and medical staff.”
RFA says the agency review looked at 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. It reports that over 80% of applications for mass production of new drugs have been canceled in light of the findings, and officials warned that further evidence of malpractice could still emerge in the scandal.
According to the agency review, much of the data gathered during clinical trials were incomplete, failed to meet analysis requirements, or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects and tampering with data that did not meet expectations, an SFDA source said.
The scandal was not a surprise to healthcare workers in China, RFA said. An unnamed hospital chief was quoted as saying that “clinical data fabrication was an open secret even before the inspection.” China’s generic drug industry has significant quality problems, RFA says, leading to a need to manipulate clinical trial data to meet standards that are high on paper. The SFDA report says that many “new” drugs are simply combinations of existing drugs, while clinical trial outcomes are written beforehand, with the data massaged to fit in. SFDA reportedly singled out third-party contract research organizations, saying they have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
Guangdong-based rights activist Mai Ke told RFA there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” he said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them, too.”
“I don’t think the 80% figure is overstated,” healthcare professional Luo Liang told RFA. “If you compare Western pharmaceuticals manufactured overseas with those manufactured in China, there is a huge difference in the ingredients. The quality of the China-made drugs is appalling.”