Data Fabrication

In a recently posted article by Ben Hargreaves in Pharmafile China’s SFDA identified data manipulation and fabrication in ~ 80% of Chinese clinical trials.

As shared in the article  the root cause is not regulation, or with the regulation for clinical trials, but the lack of adherence to the regulations.  The SFDA report identified that “many of the new drugs were found to be a combination of existing drugs, with clinical trials outcomes written beforehand and the data tweaked to fit in with the desire outcomes”

Based on the SFDA report over 80% of the pending applications (1,622) were cancelled.  Obviously one can look at the financial impact of the cost of poor data integrity products that will not go to market, factories that will be idled, jobs that will be lost.  However, according to the article ~ 1300 of the 1622 new drug applications were cancelled.  How many lives will be lost because of poor manufacturing quality? or greed in falsifying study data?  What impact will the lack of availability of these medicines have on the patient quality of life?  Yes pharmaceutical companies are for profit – but the products that are made impact patient health and quality of life – as a life science industry we should never forget this.