01 October 2016

The Inscrutable Chinese

For some long years, clinical trials conducted ex-US have been viewed with suspicion, not always veiled. Now, the Chinese government reveals the depth of the perfidy.
China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.

According to reporting, some 80% of the active ingredients (API) in US drugs are sourced from India and China.
"I don't think that the 80 percent figure is overstated," Luo said. "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."

The real question is: how much of the US-bound API is unqualified? We may never know. One review of clinicaltrials.gov (the FDA's archive) showed 8365 entries citing "China" in the record. Oops. Such trials aren't necessarily exclusively conducted in China.

US FDA has been paying some attention.
Twelve out of the 19 overseas FDA warnings issued in 2015 by the FDA's Center for Drug Evaluation and Research (CDER) for cGMP violations were delivered to Indian facilities.

There are no patriots in capitalism's CxO suites.

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