Tuesday, May 23, 2017

China/Pharma

China Trials


A Chinese government investigation has revealed that more than 80 percent of the data used in clinical trials of new pharmaceutical drugs have been "fabricated".
The report uncovered fraudulent behaviour at almost every level, and showed that some pharmaceutical companies had hidden or deleted records of potentially adverse side effects, and tampered with data that didn't meet their desired outcomes.
In light of the findings, 80 percent of current drug applications, which were awaiting approval for mass production, have now been cancelled.
The investigation, led by the Chinese State Food and Drug Administration (SFDA), looked at data from 1,622 clinical trials for new pharmaceutical drugs currently awaiting approval. The applications in question were all for Western medicine, not traditional Chinese medicine.
The SFDA found that the more than 80 percent of the data failed to meet analysis requirements, were incomplete, or totally non-existent.

They also showed that many clinical trial outcomes were written before the trials had actually taken place, and the data had been simply manipulated to match what companies wanted to find. Worst of all, it wasn't just a few scientists or pharma companies doing the dirty work. The report found that pretty much everyone involved was guilty of some kind of malpractice of fraud.
Perhaps most worryingly, even third party independent investigators tasked with inspecting clinical trial facilities are mentioned in the report as being "accomplices in data fabrication due to cut-throat competition and economic motivation".

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