First, just to let you know dear reader, this is a Casey Anthony-free blog posting.
Those who are skeptical of the device industry in this world are legion, but there are a lot of reasons to cast the occasional baleful glance at government as well. What’s interesting is how many in the media automatically assume that any clash between FDA and industry is necessarily the fault of industry.
Case in point: I was at the American Diabetes Association annual scientific sessions about two weeks ago and had a conversation with another member of the press. She said more or less that industry is to blame for any problems device makers are having with FDA approval times. I said I had no idea whether the fault lay mostly with one party or the other (or was equally shared by both) because I don’t have access to enough information to give me a clear idea of what the aggregate picture looks like.
All the same, this journalist snapped at me, “I’ve been doing this a long time, and I know.”
My first impulse was to thank her for seeing me as a babe in the woods because while I don’t look like Methuselah, I’m not exactly 20-something, either. Another reason for not taking offense was that her retort reminded me of a character in the book “A Confederacy of Dunces,” which was penned by the late John Kennedy Toole. In that book – which is an absolute scream and you should read it if you haven’t – the character going by the name Miss Trixie often snarls at the other characters, “Silence!” when they’re getting on her readily jangled nerves.
I took the hint from my so-called colleague’s rhetorical power play (i.e., I’m older than you and hence you’re stupid) and moved along with my workday. I don’t pretend to know everything about the world of medical devices and device approvals – not by a long shot – but I know a lot more than most people in my line of work, I promise you that much. Still, there’s no point in trying to persuade others of the need to have a little respect for facts or, in this case, an absence of facts. It’s almost always a waste of time.
The peculiar thing is that I hear that kind of thing a lot from people in the media, both those in the mainstream media and those in the trade press. Anyone who sticks around in the trades for very long begins to see the number of moving parts and starts to understand that government gets it wrong, too, but I’m not sure such an understanding typically dawns on those working for the major media outlets. Maybe nuance isn’t their stock in trade.
My impression is that many in the media think that FDA is the problem child when the agency is pitted against patients or doctors. When FDA and industry butt heads, industry is presumed to be the locus of corruption. The problem is that FDA’s medical device center is demonstrably guilty of malfeasance as the dismissals of two former FDAers (Robert Smith, MD, and Julian Nicholas, MD) very strongly suggest, and the agency’s sped-up approvals of some cancer drugs have boomeranged, demonstrating that the agency sometimes goes overboard in its efforts to appease patient groups as well. Thus, the hazards of assuming one party or another is automatically at fault are elucidated.
It’s a commonplace of modern life that one runs the risk of making a you-know-what out of you-know-who when one assumes anything, but that doesn’t slow us down much, does it? Nor should it, not if yours truly wants to avoid joining the ranks of the unemployed.