Post-marketing observational studies: my experience in the drug industryBMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e3990 (Published 12 June 2012) Cite this as: BMJ 2012;344:e3990
I was an employee of a major drug company for more than seven years. During most of that time I was part of the medical department, which was responsible for designing, conducting, and publishing clinical research. I was mainly involved in post-marketing observational studies. These studies are challenging because of their observational nature, very different from the controlled settings of phase II and III clinical trials. In theory, post-marketing studies are primarily used to answer an important clinical question: “Is this drug effective and safe in a non-controlled, real life setting?” However, some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.
Whether it was to highlight a questionable advantage over a “me-too” competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.
Since marketing claims needed to be backed-up scientifically, we occasionally …