FDA Asks Physicians to Play Big Brother to Big Pharma

Daniel Carlat, MD, Associate Clinical Professor of Psychiatry at Tufts University School of Medicine, makes a coherent argument in a recent Reuter’s article that today’s psychiatric services simply boil down to recurring 20-minute meetings that serve to determine if any adjustment is needed in medical therapy. Which brings up a question for me: without a therapeutic component, what does separate the psychiatrist from, say, the family practitioner/pediatrician when it comes to doling out drugs for and monitoring ADHD, depression, and other common disorders? Outside of a bit of specialized training, I’m not sure I know. Thoughts, anyone?

Carlat has made a name for himself as a fairly vocal critic of the pharmaceutical industry’s marketing practices and the negative effects they can have on medical practice and research. Interestingly, JAMA also recently published a study that concludes that “spin” is a frequent problem in the results of randomized controlled trials. It makes for interesting, if unsurprising, reading and adds fuel to the fire regarding recent revelations about several pharma companies’ ethical lapses and flouting of regulatory law, which has prompted the FDA’s development of the “Bad Ad” program.

Speaking of the FDA, it appears that Rotarix has been given the green light again and there has been a labeling change to orlistat to include information about serious liver injury.

As a reminder, the annual Associated Professional Sleep Societies (APSS) conference is coming up quickly and the scientific program offers several opportunities to explore sleep research in children and adolescents. Unfortunately for those who can’t attend in person, the APSS is not planning to offer recorded or summarized information other than a handful of presentations posted to the website after the conference ends. If you’re interested in the presentations, it looks like you need to head to San Antonio.