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Chinese fraud: Majority of data in clinical trials being fabricated for mass drug approval


Fake science

(NaturalNews) It is becoming more and more difficult to believe supposed "scientific" research. Either researchers are intentionally committing fraud or research results are inaccurate or incomplete because the entity funding it has a built-in bias.

In fact, entire countries are guilty of publishing fraudulent medical research, and the biggest violator of scientific trust may well be China.

Agence France Presse (AFP) reported recently that a newly completed survey of clinical trials in China revealed massive fraud. The country's food and drug regulator carried out a one-year review of clinical trials and concluded that 80 percent of clinical data was fabricated, Chinese state media noted.

The State Food and Drug Administration (SFDA) said in a report that the widespread scandalous behavior is the result of "breach of duty by supervision departments and malpractice" by Big Pharma firms, as well as "intermediary agents and medical staff."

Reviewers at the SFDA examined data from 1,622 clinical trial programs of new drugs awaiting regulatory approval so they can be produced and sold on the market, said a piece in the Economic Information Daily newspaper that AFP cited.

An 'open secret'

In light of the findings, more than 80 percent of applications for drug approval and manufacturing have been canceled. What's even worse, officials have warned they may find even more evidence of malpractice, meaning the percentage of tainted clinical trials could climb.

According to the agency's report a great deal of the data assembled during clinical trials was simply incomplete or did not meet analysis requirements. Other data was untraceable, meaning no one could verify it, the EID reported, quoting a source in the agency.

Officials noted further that some companies are suspected of either deleting records or otherwise deliberately hiding adverse effects of drugs, or manipulating data that did not meet expectations.

To industry insiders and those who know China's system well, however, this scandal comes as no surprise. The paper quoted an unnamed hospital administrator as saying, "Clinical data fabrication was an open secret even before the inspection." The paper noted further that the Chinese generic drug industry is rife with quality control problems and so data on clinical trials must be manipulated in order to meet high quality standards on paper.

Several drugs touted as "new" are merely combinations of existing drugs, and it is not uncommon for the outcomes of clinical trials to be written before the trials are even conducted. Data is created to fit a preconceived outcome.

The paper identified third-party inspection agencies that are known as contract research organizations. It said they had become "accomplices" in fabricating the data because of stiff competition as well as for economic reasons.

'In China, everything is fake'

A healthcare market professional said that China's domestic market for pharmaceuticals made in the West is confined strictly to a few generics or they center on joint venture drug manufacturing with foreign companies, AFP reported. Otherwise, Chinese pharmaceutical companies obtain formulas for key drugs whose patents have expired. The result is that there are no new drugs currently being developed in the country in the way they are in the West.

Doctor Zhang, an employee at a major hospital in the northern Chinese city of Xian, told EID that the problem is not with insufficient regulation governing the conduct of clinical trials and the gathering of accurate data. The real problem, he said, is in getting the regulations implemented.

"There are national standards for clinical trials in the development of Western pharmaceuticals," Zhang said, as AFP reported. He added that clinical trials have to be conducted in three phases, being assessed at the very least for safety.

Others in China say the widespread fabrication of scientific clinical trials data is emblematic of the country's culture of fakery.

"It's not just the medicines," Guangdong-based rights activist Mai Ke said. "In China, everything is fake, and if there's a profit in pharmaceuticals, then someone's going to fake them too."

Sources:

RFA.org

NaturalNews.com

LiveScience.com

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