Sometimes, one clicks something inadvertently, and lands in the oddest of places. Without any volition on my part, I ended up on the Pharmaceutical Business Review, a wondrous place with innumerable nooks and crannies. Here are just a few samples [some new nose candy and a little something for the itinerant clinical investigators]:
FDA grants Neurelis intranasal diazepam IND
Pharmaceutical Business Review
by PBR Staff Writer
07 February 2012
Neurelis has received an Investigational New Drug application [IND] from the US Food and Drug Administration [FDA] to begin clinical trials advancing the development of NRL-1 [intranasal diazepam] for the treatment of acute breakthrough seizures. NRL-1 is a proprietary formulation of diazepam delivered via a commercially available nasal sprayer, and is being developed for the management of patients who require intermittent use of diazepam. Based upon the earlier encouraging human pharmacokinetic results, the company has filed the IND. Neurelis chairman David F Hale said they hope that NRL-1 has demonstrated a pharmacokinetic profile and bioavailability compared with previous attempts at the intranasal delivery of benzodiazepines. "With the successful development of NRL-1 and approval from the FDA and other regulatory agencies, we look forward to making this product available to those patients who have epilepsy and suffer from acute repetitive seizures," Hale added. San Diego-based specialty pharmaceutical company, Neurelis, aims to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system market.
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As I wandered around their web site, I felt something akin to awe at all of the products and services being touted and bartered. It made the term medical-industrial complex come alive – the permutations of drugs, devices, support industries, clinical research programs. It was a collage of products and services bristling to enter the healthcare market. It reminded me of one of those separatory funnels we used to use in the lab – a large reservoir with a small stopcock at the bottom that let things come through a small opening one drip at a time. I suppose from the point of view of the flask, the outlet valve is a bottle-neck – the FDA, other regulatory agencies, even physicians resisting the free-flow of wares requiring pesky prescriptions or approvals of various kinds to drip through to the world of public consumption. Who would have ever thought of such a thing? 7,625 wandering clinical investigators working on 741 protocols studying such amazing innovations, things like Valium nose-drops. I suppose there’s some vantage point where this doesn’t seem like a divine comedy, but it’s not a place I’ve ever stood.
I think I’m still a bit spellbound by Dr. Healy’s book and the cognitive dissonance that came with it. Maybe some of the feeling is leftover from the Janssen Trial last month in Texas – seeing all those Training Memos, Emails, and Call-Notes flashing across the screen. I’ve been writing prescriptions for so long that I don’t even think about the fact that those prescriptions are the stopcock for that whole medical-industrial complex that I’ve spent so much time writing about recently. And somewhere during that Texas trial, I realized that doctors are the real consumer base targeted by pharmaceutical advertising and those Sales Reps, a point Dr. Healy also makes. Of course that’s right, but it never even occurred to me until recently. And if they actually make Valium nose drops, they’re going to try to sell doctors on prescribing them to patients. This website just drove home the vastness of the pharmaceutical industry hovering over clinical medicine like a cloud – pressing to maximize profits before patents run out, creating a world that selects for "new" or "novel."
I don’t much like thinking of medications as a market or myself as the proxy consumer in the marketplace, but it is doctors that the Sales Reps visit. We doctors are the target of the ads all over our journals and their websites. Doctors are the intended readers of the ghost-written experimercials and infomercials that have been inserted into our journals. 
We’re the ones required to go to C.M.E. programs that are heavily influenced by industry. This view is a cynical take on the place of physicians in the system we call health care, not a perspective I recall being taught or teaching in medical school – hardly a position I was drawn to be in. I expect that’s true for most physicians, but we’re there nevertheless.
Dr. Healy’s premise is that physicians were put there [along with the FDA and other regulatory agencies] banking on the strength of the traditional medical and scientific ethic to hold the line and protect people from the charlatanism of the patent medicines [most of which weren’t ever patented]. And I suppose that it’s inevitable that psychiatry would be the most vulnerable to being corrupted, since our medications have to do with how people actually feel and the inevitable [and understandable] softness of our science. It even makes sense that the pharmaceutical manufacturers would mount campaigns to move mental health care away from psychiatry into the realm of primary care, since treatment of symptoms is the longstanding watchword of practice there. [this, from a Zyprexa Sales seminar]:
It’s a little harder to understand why the American Psychiatric Association is helping them along by reducing mental illness to a symptom list as well eg DSM-III et al.
It is also really important to understand how pharma and med ed companies long viewed physicians–as a door to money. A doctor who “held the line” was not seen as some sort of ethical hero–just the opposite, an impediment to the dough.