Government Report Reveals Widespread Clinical Trial Fraud in China

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The Chinese pharmaceutical industry has a long and, frankly, kind of horrific history with bad science. Now, the Chinese government says a full 80 percent of drug trials awaiting approval involved “fabricated” data. The findings were published in a report by the Chinese State Food and Drug Administration (SFDA).

This is not a new problem. Quality-control issues with drug manufacturing have led to falsified data, which led to bribery and corruption, which led to the approval of dangerous products, which led to poisonings, which in turn led to the state-sanctioned execution of SFDA director Zheng Xiaoyu.

The nation’s government is hard at work trying to turn the leaky, rotting ship of the pharma industry around, but it’s slow going. In an effort to stem the tides of dirty data, the SFDA recently announced a plan to employ stricter “punishments” for industry scientists who step out of line.

They also undertook a massive investigation into all 1622 drugs awaiting SFDA approval for mass production. The results of each drug’s clinical trial were rigorously examined and analyzed for signs of doctoring, including the removal or downplaying of a drug’s negative or dangerous effects on study participants.

The report found that such practices were rampant, touching at least 80 percent of the drugs in question. Some of the data were incomplete; other parts could not be traced back to the original research; and others still simply failed to meet regulatory and scientific standards. The depth and breadth of the issues represent “… a breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents, and medical staff," the agency wrote in its report. As a result, the SFDA has canceled more than 80 percent of the current drug applications.

This all may seem shocking to us, but to those on the inside, it’s hardly news. “Clinical data fabrication was an open secret even before the inspection," said one anonymous hospital chief quoted in Radio Free Asia (RFA).

Civil rights activist Mai Ke said the problem stretches beyond Western-style drugs into Chinese traditional medicines. But "it's not just the medicines," Mai told RFA. "In China, everything is fake, and if there's a profit in pharmaceuticals, then someone's going to fake them too."

[h/t RFA]

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