Technical Communication Myths
My colleague Jessica Mahajan came across this post on the blog TechCommDood talking about common technical communication myths. Myths that apply to medical writing as well.
FDA and Lifestyle Drugs….Drawing a Line?
The winds at FDA appear to be shifting direction when it comes to “lifestyle” drugs. The mood surrounding lifestyle drugs in FDA Advisory Committees suggests the approval bar may have been moved somewhere closer to the neighborhood of infinity.
Now I want to be clear that the precise definition of lifestyle drugs is a subject of debate that I suspect will carry on for some time. I am using the term here as routinely applied in the popular press.
So when we talk about lifestyle drugs, consider that an FDA advisory panel almost unanimously voted on both safety and efficacy grounds against Boehringer Ingelheim’s flibanserin, even though the drug (a re-purposed antidepressant for female libido) did not display side effects of notable concern.
Now the first of three new diet drugs — Vivus Pharmaceuticals qnexa– is up in front of an FDA advisory committee tomorrow (July 15). The two waiting in the wings are Arena Pharmaceutcial’s lorcaserin and Orexigen’s product contrave. There is considerable churn in the pharma press on the Vivus drug as pundits read tea leaves on the future of qnexa.
Perhaps FDA and other health professionals are reconsidering where to draw the line between the social and the medical dimensions of health and treating problems that are often construed as caused by lifestyle choices (like obesity). Some clinical professionals feel that, when drug therapy is available, physicians are less willing to consider non-drug treatments, even when there is no evidence that pharmacotherapy is superior (for example see this paper by Everitt DE, Avorn J, and Baker MW). It is interesting to me to consider the arguments (pro and con) for the use of pharmacological interventions to mitigate the impact of human habit and lifestyle choices.
Some thoughts on knowledge management
Some thoughts on knowledge management that I want to share with you.
Here’s a post by Nick Milton worth reading that talks about what has to be in place to preserve corporate knowledge.
Also take a look at this post by Gil Yehuda on knowledge management in pharmaceutical industry. Yehuda mentions in his post that knowledge management should not be seen as a document management or library service. He gets it right when he says, “Its value is only realized when applied to current and future needs. Data and documents describe what was. Insight is needed to understand what is. ………….Knowledge thrives in the interpretation of facts and signals, not just in its collection.”
As I see it, the approach of Knowledge Management in the Pharma R&D environment remains principally focused on the simple management of tacit employee knowledge versus placing effort behind creating a holistic organizational ‘capability’ approach. Generally the attempt is to manage this knowledge is via documents versus the attempt to capture the knowledge and then apply the knowledge to different situations/applications.
I continue to be surprised at the level of wasted effort I see in drug development projects. Some of it is the result of the “not invented here syndrome.” While other times it is a matter that the knowledge is locked up (intentionally or unintentionally).
Much has been and continues to be made of the notion of “intellectual capital” in the life sciences. Yet from what I am able to glean through my reading and direct work in the pharmaceutical industry, not enough effort has been applied to operationalize these ideas in terms of pharmaceutical innovation and drug development.