The survey of recent Chinese government said more than 80% of the results of clinical trials medicines were fabrications, false.
A man lang Chinese herbal pharmacy in the suburb city of Chengdu, China - AFP
According Scienealert, reported on the results of the investigation under the direction of the Bureau of Food and Drug Administration national product (SFDA), reviewed 1,622 clinical trials for new drugs awaiting production license.
Accordingly, the report points out the misconduct almost at every level and the pharmaceutical companies have to hide or delete the information test showed adverse side effects, edit data related if they do not meet their expectations.
Based on these violations are detected, 80% of applications for approval of new drug registration has been canceled. Applications are related to Western pharmaceutical drugs, not the traditional Chinese medicinal herbs.
Through investigation, the SFDA has discovered more than 80% of clinical data drug testing does not meet the requirements analysis, lack of comprehensive or even "absolutely does not exist".
Investigators also found that not only are many new drugs are approved to apply in fact only a combination of drugs already on the market, but more clinical trial results of the drug was write "before the trial was going on," and the data simply are created to suit the desire of pharmaceutical companies.
The worst thing is not just a few scientists or a few pharmaceutical companies involved in this dirty work. The report found that a lot of people and at every level with a hand in profiteering from the fraudulent behavior of drug production in China.
More worrying when the investigators independent third party tasked to monitor the clinical trial basis was also named in the report with exposure of the SFDA are the "accomplices in the evil fabrications whether for competition reasons and motives of economic data. "
In fact the situation is worrisome not derived from management regulations. The regulations for drug clinical trials in China are similar to the provisions are being applied in the West.
Of which three stages are required to test the safety, effectiveness, and there has to be new drugs, better medicines are or not.
But these rules can only be communicated to and actually has no strict compliance in China.
SFDA report published on Economic Information Daily publications managed by the state. What is amazing is the leading newspaper said from a hospital director of anonymity said they were not surprised about the status of counterfeiting, embellishing the results of clinical trials with new drugs.
Though traditional Chinese medicine is not the subject of this investigation, however, some people in the same realistic assessment also very bad is happening in that area, but difficult to expose because management can not physical
Thank you for leaving valuable comments
No comments:
Post a Comment