Spinning study results — writers behind the scenes exposed
He wrote about a medical writer who seems to have major pull at Lilly, saying:
The writer seems to be doing much more than just summarizing study results — she seems actively involved in spinning the data: “John [Saunders; Regulatory official for Lilly in Europe], here is how I rewrote the HGHL disposition section to try to soften the ‘only 66 completers language...’”
In this study, 53 of 225 olanzapine patients made it to the end of one year on treatment without dropping out. That is a whopping 23.6%. Placebo patients also appeared to have not fared well (only 9.6% completed the year), but the numbers on efficacy and safety are not discussed....The point is that the writer is actively attempting to “soften" the language, likely in an attempt to make olanzapine appear more efficacious...
These echo concerns discussed last month here, reviewing ghost writers in medical research and health news and how they are influenced by interests rarely disclosed. And we wonder why we don’t always hear the full story?
Furious Seasons’ findings are extraordinary. Investigating drug company documents and emails uncovered that not only did a medication for bipolar disorder appear to perform poorly on clinical trials, but the medication raised blood sugars and the risk for diabetes among the patients. The discussions between the writer and the company officials on how to explain these unfavorable findings “against the company line on this topic” are worth reading.
The FDA approved the medication for long-term maintenance of bipolar disorder.