By the way what did they originally compare to, to work out what an imbalance is?

I find this troubling. Clinical trials should serve a worthwhile purpose. I question whether repeating a study simply because the wrong consent forms had been used previously serves a worthwhile purpose. Did the protocol for the repeat study note that a rationale for doing it was to use Janssen-specific consent forms? Did an institutional review board approve a repeat study whose rationale was to use the appropriate consent forms?

It would be very much appreciated if you kept your opinions about mothers to yourself, a “Parent’s Unconditional Love” has nothing to do with preemption, and she never be compared as such.

I may not be an expert in much of anything but that seems to be a rather broad brush you have chosen. Please guide me where I go astray, but is it not the trials that draw people to academic medicine? Don’t KOLs draw from their experiences, exposure, expertise through these trials to create a picture of the scientific landscape ahead that is typically larger than a private practitioner would see? To be a KOL seems to follow the model set forth by academic medicine: presence in the national and international communities of your respective field(s).

From the NYT article: “Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.”

It sounds like KOLs convey the comfort of credibility not easily obtained from any technical expert within the company that may have equal or greater expertise in the agent or device.

First of all, I’m not a PHD psychologist. My opinion comes from 25 years in Phase III and Phase IV clinical research in several pharmaceutical companies, mostly in CNS clinical research. I’ve dealt first hand with figures such as Dr Biderman, and know how psychiatric rating scales are developed, used and misused. What are your credentials? Let’s compare.

Look at Goodwin, Tom Insel, and Kathleen Merikangas from NIMH. For more details on Merikangas and Insel on bipolar and especially pediatric bipolar see my post under:

http://www.pharmalot.com/2008/11/14-meds-widely-used-off-label-need-more-study/

Neil as for people in industry not being specialists in their fields, this is not entirely true and there may be a mixture. However at top companies many M.D.’s and Ph.D.’s (especially the specialists) are incredibly sharp. They know the KOL’s are hacks but they use them as it’s a part of the marketing puzzle and how the system works.

The companies just don’t want to get into a position where a particular KOL gets overly powerful and can overcharge them. But this goes in phases and what’s a hot therapeutic area now may not be in a few years and a different group of KOL’s with rise and fall.

Salmon

Your statement, coming from a psychologist, sounds highly biased. Wouldn’t an equivalent statement from an academic psychiatrist who disagrees with you be that the reason that psychologists become psychologists is because they couldn’t hack medical school?

Atlex