Sunday, April 22, 2007

Welcome to Pharma BlogosphereTM: Drug Safety (Notes from Within the Industry)

Another anonymous industry insider has been spotted in the Outer Sphere of the Pharma BlogosphereTM (hat tip to PharmaGossip's Jack Friday who has "discovered" more orbs in the Pharma BlogosphereTM than anyone I know).

This new blog, entitled "Drug Safety (Notes from Within the Industry)" or just "Drug Safety" for short, claims to be "dedicated to drug safety, including whispers on the grapevine within the industry."

The welcome message (published 7 April 2007) provides a bit more detail as to the blog's mission:

"This is a blog about drug safety. Because of its subject and includes lots of stuff from within the industry, it is written anonymously.

"Will everything written about here be absolutely true? I wish I could say that it will be, but the truth is, I'm not everywhere and this isn't my day job. It will include, however, clear indications that something's been whispered and may not be established fact.

How often will I post? Don't know as yet. Probably not every day. But who knows, maybe I'll get to that point."
I am interested in why bloggers choose certain color schemes for their blogs. Drug Safety, for example, is another blog that uses a Black and Green template like this blog, PharmaGossip, and Question Authority, among others. I chose black for two reasons: I wanted to emulate other blogs I respect and I felt it was appropriate for a blog about blogs in a "blogosphere" where I can make anologies with planetary spheres and so forth. Perhaps drug saftey is a "dark" subject conjuring up images of death? The color most often associated with death is black; but that's a whole 'nother topic of discussion!

Drug Safety the blog, however, does not have a morbid ambiance, nor does it emphasize gloom, doom, and the evil nature of the drug industry. Instead, it has a very rationale tone that reminds me of someone with a scientific background and experience in clinical trail design. We know the author claims to be an "insider," but he/she could be inside a pharma company or perhaps a CRO that runs clinical trials for pharmaceutical companies.

An excerpt from a recent post ("EPO and Aranesp") demonstrates that clinical trials and post-marketing surveillance will be a focus of this blog:
"Recently, one such trial came to conclusion without any indication of a safety problem. Investors (and analysts) sighed in relief. Except the trial really doesn't address anything but the crudest of questions, since the trial isn't really large enough (and wasn't designed to be large enough) to determine if there is a safety problem with the drug. What we do know is no registry data have yet been released indicating whether there's a problem. Nor have any trials an order of magnitude larger than those recently reported on been undertaken to demonstrate the product's safety. (It seems unlikely such a trial will be mounted any time soon.) What we also know is that there's lots of questions, but little clear evidence of a problem. Which isn't to say a problem doesn't exist.

"Absence of evidence isn't the same thing as evidence of absence. Never has been, never will be."
What's your mission?
Let me know by stating it here online or by email to and I will reproduce it here. Eventually, I hope to compile a comprehensive guide to the Pharma BlogosphereTM.

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