(ECNS) -- After a one-year review on clinical drug trials, China's State Food and Drug Administration (SFDA) has found that clinical data of more than 80 percent of new medicines were fabricated, due to breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff.
Results from the review of data on 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production has caused quite a stir across the whole industry, Economic Information Daily reported.
Industry insiders say that more than 80 percent of applications for mass production of new drugs have been withdrawn by pharmaceutical companies or rejected by the watchdog, adding that the ongoing campaign could disclose even more problems in future.
Much of the data gathered during clinical trials were incomplete, failed to meet analysis requirements or were untraceable, a worker with the food and drug department told the paper.
Some companies were suspected of purposely hiding or dropping records of adverse effects and tampering with data that did not meet expectation, it was added.
"Clinical data fabrication was an open secret even before the inspection," the paper quoted the head of a top-class hospital in west China as saying.
According to the source, pharmaceutical companies casually combined some old drugs, found several hospitals willing to conduct clinical trials, then produced a report as per pre-designed results, and thus a new medicine was born so long as the food and drug administration gave the nod.
"How could such a hotch-potch approach to drug development ensure the medicinal quality and safety?" said a R&D executive at a pharmaceutical company based in Nanjing.
"The direct consequence of clinical data fabrication is an effective medicine."
According to industry insiders, most of China's generic drugs do not live up to the standards of their brand-name original counterparts. Therefore, hiding, omitting or selectively using data for clinical trials is commonplace in order to get approval from regulators.
As a result, the China Food and Drug Administration has tightened supervision on generic drugs. Yu Dechao, the board chairman of Innovent Biologics, predicted that half of existing generic drugs on the market could be eliminated eventually.
The paper has found violations of rules on clinical drug trials by pharmaceutical companies, intermediary agencies and doctors.
In particular, contract research organizations (CROs), which are supposed to serve as third-party quality inspection agencies, have turned into accomplices in data fabrication due to cutthroat competition and economic motivations, the paper warned.
The China Food and Drug Administration has made it clear that if fabrication is detected in clinical research, new applications made by the same applicant for drug registration will not be accepted for three years, while materials for clinical trials that participated in or organized by those who are directly responsible for the fabrication will not be accepted for ten years.
Industry insiders suggest improved supervision, including a possible life-time ban in relevant industries on those who fabricate data, is needed.
