An investigation by the State Food and Drug Administration (SFDA) of China has uncovered a disturbing scale of fraudulent practice in clinical trials accomplished in the country, quoted to be the result of a “breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff.”

Third party independent investigators responsible for inspecting the clinical trial facilities were also stated in the report as “accomplices in data fabrication due to cut-throat competition and economic motivation.”

The SFDA carried out a one-year review of 1,622 clinical pharmaceutical trials that were awaiting regulatory approval, only to reveal that some companies have concealed or deleted findings of potentially adverse side effects – concluding that approximately 80% of clinical trial data was either “fabricated”, incomplete, or completely non-existent.

Local industry insiders unsurprised by findings


More shockingly, it was found that many outcomes of the clinical trials were written prior to the actual trial having taken place, with the data manipulated to match a more desired outcome. Several of these ‘new’ drugs awaiting approval were also found to be, in fact, a medley of existing drugs.

In light of the findings, it has been reported that 80% of applications for mass production of new drugs have been cancelled, with officials forewarning that further acts of such malpractice could potentially emerge.

"I don't think that the 80% figure is overstated," said healthcare professional Luo Liang.

"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,” he said, further describing the domestic market for Western pharmaceuticals as either limited to basic generic products that have been available for a long time, or “revolving around joint-venture pharmaceutical manufactures with foreign companies.”

However, the manipulation of clinical trials data came to no surprise to associates from the trade, due to the quality issues that have been plaguing China’s drug and pharmaceutical industry.

“Clinical data fabrication was an open secret even before the inspection,” said an unnamed hospital chief.

Luo also posited that the current scholastic culture which is accepting of data manipulation is due to an underdeveloped field of academic ethics in China.

“There are national standards for clinical trials in the development of Western pharmaceuticals,” added Zhang, a doctor from the northern city of Xian, who further explained that clinical trials done in the country must be carried out in three phases and assessed for safety.

"But I don't know what happened here,” he added.

Fraudulent behaviour not limited to Western drug industries


While the applications reviewed in the study were only for Western medicine, the problem may also be ongoing in the traditional Chinese medicine industry, according to Guangdong-based rights activist Mai Ke, who said that “It's just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines.”

"It's not just the medicines," he added as he highlighted the existence of a prevalent imitative culture across all products made in the country, positing that public safety issues in China are not limited to the pharmaceutical industry.

Luo further theorised that the situation is made such because local pharmaceutical companies that attempt to produce Western drugs are struggling to make profit.

"Either that, or Chinese pharmaceutical factories get hold of the formula for certain drugs whose patents have expired," he said. "There are no new drugs in development in the same way that there are overseas."

Chinese scientists are not the only ones committing fraudulent acts


Although the study was specific to clinical trials in China, the findings reflect that such fraudulent practices exist across the pharmaceutical industry globally.

An earlier study from Stanford University revealed that many publications done in the recent years appear to be redundant, and that the highly competitive environment in the field of academics pushes scientists to take shortcuts in the pressure to publish. The study also stated that large numbers of studies carried out were not published due to unfavourable results, leading to a distortion of evidence and data that were ultimately published.

In light of the situation, the United Nations has called for global action on transparency in clinical trials on 14 September this year, requesting government bodies across the globe to pass legislation that will require registration of clinical trials and full disclosure of methods and results in publications. MIMS

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Sources:
http://www.clinicalleader.com/doc/clinical-news-roundup-is-percent-of-china-s-clinical-data-fabricated-0001
http://www.rfa.org/english/news/china/clinical-fakes-09272016141438.html
http://www.sbs.com.au/topics/science/fundamentals/article/2016/10/03/report-reveals-80-data-chinese-clinical-trials-have-been-fabricated
http://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated
http://www.pharmafile.com/news/509123/80-chinese-clinical-trials-data-fabricated