Note About Clinical Studies or Bipolar is a Hot Field

A spate of studies on bipolar disorder have been released in the last few days. I'll discuss them in more detail later today. But, first, some background.

There is a large psych conference going on in Europe, thus the releases. Many of these studies are of various meds--although there's a decided emphasis on Seroquel--and their effects on aspects of bipolar (ie., BP and depression, rapid cycling, etc.). I'm glad that researchers seem most interested in BP these days. Until recently, the focus of much research was geared to depression and schizophrenia. So my hunch is that there must be money for researchers in going after BP, and Pharma companies must be willing to foot the bill. Yes, I am cynical.

What prompts my cynicism most of all is that all of the studies I have been able to read so far present their conclusions as groundbreaking based upon 8-week studies in an academic clinical setting--ie, not the real world--and measuring the response of med X in BPers versus the response of BPers only taking a placebo. In other words, these are classic efficacy trials. Here, docs, pharma companies and regulators are interested in the basic question of does med X "work" in relation to patients taking a sugar pill. Classic medical research method. These are not effectiveness trials, which would measure the response of patients to med X versus placebo response over a longer period of time and in a more real world setting.

Efficacy trials--in the context of studying mental illness and approving drugs for the market--produce very limited answers, but they remain the basis upon which your doctor may well make the decision to prescribe you med X. You, then, become the guinea pig--or a very informal effectiveness trial of one in effect. That's bullshit.

It is deeply arrogant and abusive of patients to rachet up their hope--as the pharma companies' press releases and subsequent press coverage do very slyly--based upon short term studies. It's dishonest in fact. The psych business needs a lot more honesty from researchers, policymakers, pharma companies and doctors if we are to arrive at answers that truly mean something for patients' lives. The media also needs to play a part in this by asking sketpical questions of the above actors. In this case, the media has come up short for over 15 years.

And we are the only group in the psych business that matters. But our interests are not well served in the current power arrangment, in which we don't even have much of a share or a voice. That is also bullshit and must change.