While diagnosis is critical to providing evidence based medical treatment, diagnosis in behavioral healthcare arising from the Diagnostic and Statistical Manual of the American Psychiatric Association has notoriously poor reliability and validity [11]. An over-reliance on this descriptive, symptom-based diagnostic view can lead to a “pill for every ill” prescriptive practice [12]. More important than a diagnostic label is an assessment of how a patient’s problems impact his or her life [13] and what can be done about it [14]. Closely aligned with a health home perspective and integrated care, a thorough and systematic assessment gathers information from all significantly involved persons and includes developmental, environmental, familial, and socio-cultural understandings of both problems and solutions. Given that up to 50% of patients referred for mental health services do not make the first appointment [15], it is arguably best that the assessment and treatment be a part of routine care rather than conducted elsewhere. When they are, benefits ensue. For example, a recent meta-analysis reported improvements in both mental and physical health when brief psychotherapy was incorporated into primary care settings to treat anxiety and depression [16].

A thorough assessment includes the possibility that the problem(s) in question may be best described as part of the human condition or a natural response to the stress of life, particularly poverty and injustice, or in other words, the right not to have normal behavior labeled as pathological. Pharmaceutical marketing has led to what has been called “disease mongering,” or the creation or expansion of disorders to increase revenues of a for-profit industry [17]. For example, a recent study compared the number of visits of patients diagnosed with bipolar disorder for ages 0 - 19 for the years 1994-1995 and 2002- 2003 [18]. Investigators found a 40-fold increase in visits for this diagnosis, a questionable increase despite the ostensible explanation of advances in detection of a heretofore undetected illness. Of these patients diagnosed with bipolar disorder, more than 90% were treated with psychoactive medications, approximately one half given an antipsychotic and one third given an anticonvulsant. Despite the fact that no evidence supports polypharmacy with youth, most were prescribed more than one medication, and only 4 out of 10 received psychotherapy. A thorough assessment starts with an understanding of the patient within the realm of normal human behavior.

The risks and benefits of any intervention should be transparently discussed. Such open discussions allow patients to decide which treatment offers the best option in line with their own values and cultural contexts [8]. For example, parents of children struggling with depresssion can be shown the efficacy and safety data about cognitive behavioral therapy (CBT) vs. antidepressant treatment, alone or in combination. CBT alone had comparable outcome at 30 weeks while the antidepressant treatment groups had significantly more psychiatric adverse events; six suicide attempts occurred in the medication groups v. one in the nonmedication group [10, 19-21]. Similarly, patients should be informed about recent meta-analytic data showing that antidepressants are not more effective than placebo except for a small portion of patients in the very severe range [22,23]. Paradoxically, despite the growing evidence of the minimal therapeutic effects of antidepressants, sales for them increased in 2010 in the US [2] Concomitant to a risk/ benefit discussion, patients should be informed about the likely outcome of no treatment at all. Problems or conditions often improve without intervention. With depresssion, for example, spontaneous remission ranges from 20% to 60% for any given episode [24,25].

As part of a risk/benefit discussion, patients also should be informed that medical science has yet to reliably identify any biological markers or chemical imbalances for any psychiatric diagnosis [12,26]. Similarly, there is no evidence that any psychotropic medications repair chemical imbalances or other proposed neurochemical substrates of disorders [e.g., 27]. Understanding the limits of scientific understanding paves the way for an informed choice about treatment options.

Based on recent reviews of the evidence regarding the efficacy and safety of psychiatric medications, a risk/ benefit analysis suggests that psychotherapy be considered first, depending on patient preferences [9,10]. Patients, therefore, have a right to be treated by a physician who sees psychosocial options as viable first line, stand alone treatments (including psychotherapy, exercise and nutrition, problem solving, community, spiritual, and peer options) for emotional and behavioral problems. For example, in the case of depression, contrary to conventional wisdom, psychological treatments have been shown to be as effective as medication treatments in the short run with more durable benefits in the long run, especially when patient rated measures are considered, even if the depression is severe [28-30]. Combined treatments have not consistently fared better than psychological treatments alone over long term outcome but they have tended to have better results than medication treatment alone [31-34].

Since we are unaware of any scientific studies addressing the combination of more than two psychotropic medications [35] with adults (or more than one with children), this should be the upper limit. Even two medication combinations have been rarely studied, and when they have, underwhelming results seem the norm. For example, “treatment resistant depression” prompted the STAR*D (Sequenced Treatment Alternatives to Relieve Depression), a study that examined the impact of augmentation or medication switching strategies for depresssion when a traditional regimen of a single SSRI failed [36]. The average remission rate (which was less than the traditional placebo response) based on the primary outcome measure was 28% (Level 1—initial regimen of a single SSRI) and 25% (Level 2—patients augmented or switched), or a total remission rate of 39% when considering those who remitted at both levels together out of a total of 2876 participants. A more stringent perspective would take each level as a different treatment episode, resulting in an average remission rate of 27% across levels. Moderate to intolerable adverse events were experienced by 28% of participants at Level 1 [37] and 51% at Level 2 [38,39]. In addition, overall results from the large scale Combining Medications to Enhance Depression Outcomes (CO-MED) [40] study showed that a single antidepressant produced the same remission rate as combined antidepressants and that therapy with 2 medications resulted in more adverse events.

Prescribing psychotropics without FDA or other governing body approval, so called off-label prescribing should also be rare. Although polypharmacy and off label prescriptions of psychotropics tend to expose patients to increased risks and side effects, such practices have become increasingly popular, particularly in vulnerable populations of children and the elderly [12,41]. For example, a study of 11,700 youth covered by Medicaid found that the number of children newly treated with antipsychotics increased from 1482 in 2001 to 3110 in 2005 [42]. This means that 26% of these youth were taking antipsychotics in 2005, suggesting many off label prescriptions. Other studies have found that children covered by Medicaid were prescribed antipsychotics at a rate four times higher than children with private insurance, were more likely to receive antipsychotics for unapproved uses, and were more likely to receive multiple medications [43,44], despite the fact that not one randomized clinical trial to our knowledge has examined polypharmaceutical intervention with children. Poor children, apparently, are vulnerable to psychotropics used as interventions of control rather than therapy.

Finally, patients have a right for psychotropic medications to be used as primarily a short term treatment. Most of the scientific psychiatric database consists of controlled studies of 6 to 12 weeks in duration [8,45]. There are not enough controlled investigations beyond 12 weeks to guide patients or prescribers in terms of safety and efficacy. When longer trials are done, results are unimpressive. For example, the STAR*D reported that 58% of those who responded through the four levels relapsed at one year follow-up [38]. In a large scale investtigation of antipsychotics with adults with schizophrenia, 74% of participants discontinued before 18 months, largely due to inefficacy and intolerable side effects [46]. Finally, a study of antipsychotics with youth diagnosed with schizophrenia reported that only 12% of youth both responded and stayed on antipsychotics for a year [47]. Long term use of psychotropics does not appear to be empirically supported.

Clinicians and patients often differ substantially in their judgment of improvement in clinical trials [44]. A metaanalysis of 22 antidepressant studies (N = 2230) found that antidepressants showed an approximate 20% advantage over placebo on clinician-rated measures, but none on patient-rated measures [48]. This is the rule rather than the exception [21,49]. The lack of endorsement of efficacy by patients in clinical trials begs the question: If patients don’t notice advantage over placebo, how significant can the advantage rated by others be?

Using patient rated measures of treatment response not only in clinical trials but also in practice will allow more accurate assessment of medication benefit and may even improve outcomes. Incorporating patient-rated outcomes into treatment, for example, has been found to signifycantly improve outcomes in psychotherapy, allowing the clinician to tailor intervention based upon patient response [14,50]. Monitoring treatment outcomes would allow patients to change treatment approaches if any given treatment was not working after a reasonable period of time.

In the absence of benefit, patients also have a right not to have their dosage increased. There appears to be a weak dose response relationship with psychotropic medications. Response does not typically improve with doses higher than those already in the recommended therapeutic range, for example, with antidepressants [51,52]. However, side effects and the risk of adverse events significantly increase with higher doses. Finally, patients have a right to be tapered off ineffective medications before additional medications are prescribed given that augmentation studies have shown limited benefits. In other words, patients have a right to experience a medication free period to see if they feel better before a new medication is added.

This would require a publicly accessible database of all published and unpublished data, as well as a straightforward presentation of the risks and benefits free of spin and marketing [53]. Unfortunately our scientific database appears to be distorted by ghost written articles and skewed by publication bias, i.e., publishing studies that are favorable to the pharmaceutical industry products [54,55], sometimes recasting unfavorable outcomes into the conclusion that the medication is “efficacious, safe, and well tolerated.” Until an unvarnished database that includes all the data (including raw data) becomes available, the Cochrane database may serve as the best resource.