Tuesday, February 13, 2007

Medical Writers Moving Up The Ladder

I suppose that the American Medical Writers Association can stand proud and tall. After all, a medical writer seems to have some major pull at Lilly. What am I talking about?

According to documents reviewed by, and available on, Furious Seasons, it seems that the medical writer has a lot of input, perhaps more than the doctors who were running the study, such as Maricio Tohen.

OK, yes, she is a medical writer, so she should write about medical stuff. I'm not denying that. 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 and not discussed in much detail in the document outside of some unfavorable data on glucose (more on that later). The point is that the writer is actively attempting to "soften" the language, likely in an attempt to make olanzapine appear more efficacious.

The medical writer is celarly deeply involved with writing whatever this publication turned out to be. I don't know what happened to this publication. Perhaps it was submitted to some refulatory agency? My concern is that this may be reflective of general practice -- the medical writer "softens" language as appropriate and the doctors whose names appear on the study may actually contribute a relatively minimal amount (or none at all) to the final study writeup.

Maybe I'm reading too much into this?

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