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The pharmaceutical industry has made it very difficult to know what the clinical trial evidence is regarding psychotropics. As a consequence, primary care physicians and other front-line practitioners are at a disadvantage when attempting to adhere to the ethical and scientific mandates of evidence-based prescriptive practice. BARRY DUNCAN and DAVID ANTONUCCIO call for a higher standard of prescriptive care derived from a risk/benefit analysis of clinical trial evidence. The authors assert that current prescribing practices are often empirically unsound and unduly influenced by pharmaceutical company interests, resulting in unnecessary risks to patients. In the spirit of evidenced-based medicine’s inclusion of patient values as well as the movement toward health home and integrated care, a patient bill of rights for psychotropic prescription is presented. Guidelines are offered to raise the bar of care equal to the available science for all prescribers of psychiatric medications. This is a Psychotherapy in Australia reprint of an earlier article.
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  1. 1. patient bill of rights for psychotropicprescription: A call for a higher standardof careBARRY L. DUNCAN AND DAVID O. ANTONUCCIO The pharmaceutical industry has made it very difficult to know what the clinical trial evidence is regarding psychotropics. As a consequence, primary care physicians and other front-line practitioners are at a disadvantage when attempting to adhere to the ethical and scientific mandates of evidence-based prescriptive practice. BARRY DUNCAN and DAVID ANTONUCCIO call for a higher standard of prescriptive care derived from a risk/benefit analysis of clinical trial evidence. The authors assert that current prescribing practices are often empirically unsound and unduly influenced by pharmaceutical company interests, resulting in unnecessary risks to patients. In the spirit of evidenced-based medicine’s inclusion of patient values as well as the movement toward health home and integrated care, a patient bill of rights for psychotropic prescription is presented. Guidelines are offered to raise the bar of care equal to the available science for all prescribers of psychiatric medications.L argely because of the unprecedented marketing bythe pharmaceutical industry as well the pharmaceutical companies have made it very difficult for everyday practitioners to have an accurate Antonuccio, Danton & McClanahan, 2003). Antonuccio et al. (2003) conclude, ‘It is difficult to think ofas the transition of behavioural health picture of the trial data. Marcia any arena involving informationto primary care venues, spending for Angell, former editor of the New about medications that does not havepsychiatric medications in the US England Journal of Medicine concludes: significant industry financial orincreased from nearly $8 billion in ‘It is simply no longer possible to marketing influences.’ (p. 1030). Given1997 to $20 billion in 2004 (Stagnitti, believe much of the clinical research that the infiltration of industry influence,2007) reaching over $40 billion in sales is published, or to rely on the judgment relying on press reports, web pages,in 2010 (IMS Institute for Healthcare of trusted physicians or authoritative and even the academic literature can beInformatics, 2011).1 Concurrently, medical guidelines. I take no pleasure in misleading as a basis for sound clinicalthe use of psychotherapy has declined this conclusion, which I reached slowly decisions.(Olfson & Marcus, 2010) and and reluctantly over my two decades as Compounding the problem,community behavioural intervention an editor of The New England Journal of primary care and other front linehas fallen or remained flat (Case, Medicine’ (Angell, 2009). practitioners often do not have theOlfson, Marcus, & Siegel, 2007). The vast reach of the pharmaceutical time, formal education, and training Are these patterns justified by the industry in psychotropic prescription to properly evaluate the clinical trialclinical trial evidence? Unfortunately, practices extends to the Internet, literature, or to know the range of print, and broadcast media, direct- treatment options available to permit1 Comparable Australian figures track to consumer-advertising, ‘grassroots’ matching with patient preferences. The spending on psychiatric drugs from $82.1 million in 1992/93 to $625.9 consumer-advocacy organisations, unfortunate result is an over reliance on million in 2004/2005, to $834 million in professsional guilds, medical psychotropics as a first line intervention 2010/2011 (Department of Health and schools, prescribing physicians, and an under-reliance on safer and Ageing, 2007; Australian Institute of and research — even into the board comparably effective psychosocial Health and Welfare, 2012). rooms of the FDA (Angell, 2009; options.48 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications
  2. 2. Building on earlier efforts to diagnostic view can lead to a ‘pill for that up to 50% of patients referred forestablish patient informed consent every ill’ prescriptive practice (Piasecki mental health services do not make theregarding psychotropics (Cohen & & Antonuccio, 2010). More important first appointment (Hoge, Auchterlonie,Jacobs, 2000; Sparks & Duncan, than a diagnostic label is an assessment & Milliken, 2006), it is arguably best2008), this article calls for a higher of how a patient’s problems impact his that the assessment and treatmentstandard of prescriptive care derived or her life (Beutler & Malik, 2002b) and be a part of routine care rather thanfrom a risk/benefit analysis of what can be done about it (Duncan, conducted elsewhere. When they are,clinical trial evidence (Brown et al,2008; Sparks, Duncan, Cohen &Antonuccio, 2010). The authors assert …many current prescribing practices arethat many current prescribing practicesare empirically unsound and unduly empirically unsound and unduly influencedinfluenced by pharmaceutical companyinterests, which tend to inflate benefits by pharmaceutical company interests, whichand minimise risk. In the spirit of evidenced based tend to inflate benefits and minimise risk.medicine’s inclusion of patient valuesas well as the movement toward 2010). Closely aligned with a health benefits ensue. For example, a recenthealth home (i.e., an approach to home perspective and integrated care, meta-analysis reported improvementsproviding comprehensive primary a thorough and systematic assessment in both mental and physical healthcare that emphasises physician/ gathers information from all significantly when brief psychotherapy waspatient collaboration), we present a involved persons and includes incorporated into primary care settingspatient bill of rights for psychotropic developmental, environmental, familial, to treat anxiety and depression (Cape,prescription. The Bill of Rights is the and socio-cultural understandings of Whittington, Buszewicz, Wallace &name of the first ten amendments both problems and solutions. Given Underwood, 2010).to the U.S. Constitution introducedby James Madison to the First U.S.Congress in 1789. The Bill of Rightslimits the power of the U.S. FederalGovernment, protecting the naturalrights of liberty and property, includingfreedom of speech, free press, freeassembly, and freedom from cruel andunusual punishment. This article proposes a bill of rightsdesigned to preserve the autonomy andfreedom of patients who are prescribedpsychotropic drugs in the hopes ofcreating an evolving document andongoing discussion of this critical issue.Guidelines to raise the bar of careequal to the available science for allprescribers of psychiatric medicationsare offered.A patient bill of rights forpsychotropic prescription1. Patients have a right to athorough diagnostic and functionalassessment by a behaviouralhealth care specialist While diagnosis is critical toproviding evidence-based medicaltreatment, diagnosis in behaviouralhealthcare arising from the Diagnosticand Statistical Manual of the AmericanPsychiatric Association has notoriouslypoor reliability and validity (Beutler& Malik, 2002a). An over-relianceon this descriptive, symptom-based Photo: © Savina Hopkins, 2013. PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 49 Copyright © 2013, PsychOz Publications
  3. 3. A thorough assessment includes had comparable outcome at 30 weeks Cohen & Antonuccio, 2010). Patients,the possibility that the problem(s) while the antidepressant treatment therefore, have a right to be treatedin question may be best described groups had significantly more by a physician who sees psychosocialas part of the human condition or a psychiatric adverse events; six suicide options as viable first line, stand alonenatural response to the stress of life, attempts occurred in the medication treatments (including psychotherapy,particularly poverty and injustice, groups v. one in the nonmedication exercise and nutrition, problemor in other words, the right not to group (Sparks, Duncan, Cohen & solving, community, spiritual, and peerhave normal behaviour labelled Antonuccio, 2010; Antonuccio, 2008; options) for emotional and behaviouralas pathological. Pharmaceutical Treatment for Adolescents with problems. For example, in the case ofmarketing has led to what has been Depression Study, 2004; Treatment for depression, contrary to conventionalcalled ‘ disease mongering, or the Adolescents with Depression Study, wisdom, psychological treatmentscreation or expansion of disorders to 2007). Similarly, patients should be have been shown to be as effective asincrease revenues of a for-profit industry informed about recent meta-analytic medication treatments in the short(Healy, 2006). For example, a recent data showing that antidepressants run with more durable benefits in thestudy compared the number of visits are not more effective than placebo long run, especially when patient-of patients diagnosed with bipolar except for a small portion of patients rated measures are considered, even ifdisorder for ages 0–19 for the years in the very severe range (Fournier the depression is severe (Antonuccio,1994–1995 and 2002–2003 (Moreno, et al, 2007; Kirsch et al, 2008). Danton & DeNelsky, 1997; HollonLaje, Blanco, Huiping, Schmidt & Paradoxically, despite the growing et al, 2005). Combined treatmentsOlfson, 2007). Investigators found evidence of the minimal therapeutic have not consistently fared bettera 40-fold increase in visits for this effects of antidepressants, sales than psychological treatments alonediagnosis, a questionable increase for them increased in 2010 in the over long-term outcome, but theydespite the ostensible explanation of US (IMS Institute for Healthcare have tended to have better resultsadvances in detection of a heretofore Informatics, 2011). Concomitant to a than medication treatment aloneundetected illness. Of these patients risk/benefit discussion, patients should (Antonuccio, Burns, & Danton, 2002;diagnosed with bipolar disorder, be informed about the likely outcome Blom et al, 2007; Dimidjian et al,more than 90% were treated of no treatment at all. Problems or 2006; Dobson et al, 2008).with psychoactive medications, conditions often improve without 4. Patients have a right to be exposedapproximately one half given an intervention. With depresssion, for to the lowest risk of adverse eventsantipsychotic and one third given an example, spontaneous remission ranges from psychotropic medications — aanticonvulsant. Despite the fact that from 20% to 60% for any given episode right to a ‘first do no harm approach’.no evidence supports polypharmacy (Andrews, 2001; Posternak & Miller,with youth, most were prescribed more 2001). Since we are unaware of anythan one medication, and only four As part of a risk/benefit discussion, scientific studies addressing theout of ten received psychotherapy. A patients also should be informed that combination of more than twothorough assessment starts with an medical science has yet to reliably psychotropic medications (Yury,understanding of the patient within the identify any biological markers Fischer, Antonuccio, Valenstein, &realm of normal human behaviour. or chemical imbalances for any Matuszak, 2009) with adults (or more psychiatric diagnosis (Piasecki & than one with children), this should be2. Patients have a right to be the upper limit. Even two medication Antonuccio, 2010; Duncan et al,informed about the safety and combinations have been rarely studied, 2004). Similarly, there is no evidenceefficacy of treatment options and when they have, underwhelming that any psychotropic medicationsincluding psychological results seem the norm. For example, repair chemical imbalances or othertreatment alone, medication ‘treatment resistant depression’ proposed neurochemical substrates ofalone, psychological treatment prompted the STAR*D (Sequenced disorders (e.g., Lacasse & Leo, 2005).combined with medication, Treatment Alternatives to Relieve Understanding the limits of scientificas well as no treatment. Depression), a study that examined the understanding paves the way for an The risks and benefits of any informed choice about treatment impact of augmentation or medicationintervention should be transparently options. switching strategies for depresssiondiscussed. Such open discussions when a traditional regimen of a singleallow patients to decide which 3. Patients have a right to be treated SSRI failed (Rush et al, 2006b). Thetreatment offers the best option in line with psychosocial interventions average remission rate (which was lesswith their own values and cultural alone if they so choose. than the traditional placebo response)contexts (Sparks & Duncan, 2008). Based on recent reviews of the based on the primary outcome measureFor example, parents of children evidence regarding the efficacy and was 28% (Level 1 — initial regimenstruggling with depresssion can be safety of psychiatric medications, a of a single SSRI) and 25% (Levelshown the efficacy and safety data risk/benefit analysis suggests that 2 — patients augmented or switched),about cognitive behavioural therapy psychotherapy be considered first, or a total remission rate of 39% when(CBT) vs. antidepressant treatment, depending on patient preferences considering those who remitted atalone or in combination. CBT alone (Brown et al, 2008; Sparks, Duncan, both levels together out of a total of50 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications
  4. 4. participants. A more stringentperspective would take each level as adifferent treatment episode, resultingin an average remission rate of 27%across levels. Moderate to intolerableadverse events were experienced by28% of participants at Level 1 (Trivediet al, 2006b) and 51% at Level 2 (Rushet al, 2006a; Trivedi et al, 2006a).In addition, overall results from thelarge scale Combining Medications toEnhance Depression Outcomes (CO-MED) (Rush et al, 2011) study showedthat a single antidepressant producedthe same remission rate as combinedantidepressants and that therapy withtwo medications resulted in moreadverse events. Prescribing psychotropicswithout FDA or other governingbody approval, so called off-labelprescribing should also be rare. of 6 to 12 weeks in duration (Sparks & Adolescents with Depression Study,Although polypharmacy and off-label Duncan, 2008). There are not enough 2007; Jureidini et al, 2004). The lackprescriptions of psychotropics tend to controlled investigations beyond 12 of endorsement of efficacy by patientsexpose patients to increased risks and weeks to guide patients or prescribers in clinical trials begs the question:side effects, such practices have become in terms of safety and efficacy. If patients don’t notice advantageincreasingly popular, particularly in When longer trials are done, results over placebo, how significant can thevulnerable populations of children and are unimpressive. For example, the advantage rated by others be?the elderly (Piasecki & Antonuccio STAR*D reported that 58% of those Using patient-rated measures2010; Sparks & Duncan, 2012). For who responded through the four levels of treatment response not only inexample, a study of 11,700 youth relapsed at one year follow-up (Rush et clinical trials but also in practicecovered by Medicaid (US) found that al, 2006a). In a large scale invetigation will allow more accurate assessmentthe number of children newly treated of antipsychotics with adults with of medication benefit and may evenwith antipsychotics increased from schizophrenia, 74% of participants improve outcomes. Incorporating1482 in 2001 to 3110 in 2005 (Pathak, discontinued before 18 months, largely patient-rated outcomes into treatment,West, Martin, Helm, & Henderson, due to inefficacy and intolerable side for example, has been found to2010). This means that 26% of these effects (Lieberman et al, 2005). Finally, significantly improve outcomes inyouth were taking antipsychotics a study of antipsychotics with youth psychotherapy, allowing the clinicianin 2005, suggesting many off-label diagnosed with schizophrenia reported to tailor intervention based uponprescriptions. Other studies have found that only 12% of youth both responded patient response (Duncan, 2010;that children covered by Medicaid were and stayed on antipsychotics for a year Lambert, 2010). Monitoring treatmentprescribed antipsychotics at a rate four (Findling et al, 2010). Long-term use outcomes would allow patients totimes higher than children with private of psychotropics does not appear to be change treatment approaches if anyinsurance, were more likely to receive empirically supported. given treatment was not working afterantipsychotics for unapproved uses, and a reasonable period of time.were more likely to receive multiple 5. Patients have a right to monitor In the absence of benefit, patientsmedications (Crystal, Olfson, Huang, their treatment response with also have a right not to have theirPincus, & Gerhard, 2009), despite the patient-rated outcome measures. dosage increased. There appears to befact that not one randomised clinical Clinicians and patients often differ a weak dose response relationship withtrial to our knowledge has examined substantially in their judgement of psychotropic medications. Responsepolypharmaceutical intervention with improvement in clinical trials (Zito does not typically improve withchildren. Poor children, apparently, et al, 2009). A metaanalysis of 22 doses higher than those already inare vulnerable to psychotropics used antidepressant studies (N = 2230) the recommended therapeutic range,as interventions of control rather than found that antidepressants showed for example, with antidepressantstherapy. an approximate 20% advantage over (Antonuccio, Danton, DeNelsky, Finally, patients have a right for placebo on clinician-rated measures, Grenberg, & Gordon, 1999; Kirsch,psychotropic medications to be used but none on patient-rated measures Moore, Scoboria, & Nichols, 2002).primarily as a short-term treatment. (Greenberg, Bornstein, Greenberg, & However, side effects and the riskMost of the scientific psychiatric Fisher, 1992). This is the rule rather of adverse events significantlydatabase consists of controlled studies than the exception (Treatment for increase with higher doses. Finally, PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 51 Copyright © 2013, PsychOz Publications
  5. 5. have a right to be tapered influence should be separated Duncan, Cohen & Antonuccio, 2010;off ineffective medications before from science and practice. Pigott, Leventhal, Alter, & Boren,additional medications are prescribed • A data base of the risks and 2009). A more stringent perspectivegiven that augmentation studies have benefits of psychotropics, reveals that after a year of continuationshown limited benefits. In other words, independent of industry influence, treatment following remission, ofpatients have a right to experience a should be available to prescribers the 4041 patients who entered themedication free period to see if they and patients. program only 108 (3%) had a sustainedfeel better before a new medication is remission — all the other patients Conclusionsadded. either dropped out or relapsed (Rush et The methodology of medication al, 2006a).6. Patients have a right to untainted trials needs wholesale reform to The unprecedented promotion of thescientific data conveyed in a address inherent flaws: analysis to pharmaceutical industry that targets allconsumer friendly way regarding detect penetration of the double players in health care forms the basispsychotropic medication blind and/or the use of psychoactive of pharmacology’s growing centrality This would require a publicly placebos; use of patient-rated measures; in psychiatric treatment. While someaccessible database of all published long-term evaluation of efficacy and patients may be helped with this focus,and unpublished data, as well as a safety; inclusion of investigators it misdirects primary care away fromstraightforward presentation of the without pharmaceutical company a safer intervention with comparablerisks and benefits free of spin and affiliations; and independent reporting efficacy — psychotherapy, as well asmarketing (Antonuccio & Healy, of the findings to remove marketing other community-based, culturally2008). Unfortunately, our scientific spin. Regarding practice, untainted sensitive options. Additionally, itdatabase appears to be distorted by information should be made available promotes prescriptive treatments ofghost written articles and skewed to prescribers of psychotropics. questionable sustainability, fraughtby publication bias, i.e., publishing Pharmaceutical company press with potentially dangerous effects.studies that are favourable to the releases and ‘detailing’ from sales This article proposed a patientpharmaceutical industry products representatives should include bill of rights and psychotropic(Turner, Matthews, Linardatos, independent evaluation of claims prescription guidelines that embodyTell, & Rosenthal, 2008; Wieseler, as well as non-medication options. a higher standard of care, makingMcGaura, & Kaiser, 2010), sometimes Incentives and benefits to prescribers the patient a partner in the selectionrecasting unfavourable outcomes into should be eliminated. Psychosocial and administration of treatment.the conclusion that the medication interventions have neither marketing Such a collaboration allows theis ‘efficacious, safe, and well-tolerated’. representatives nor budgets and integration of the best researchUntil an unvarnished database that therefore a more concerted effort to evidence with clinical expertise andincludes all the data (including raw include them is needed. patient values (APA Presidentialdata) becomes available, the Cochrane The STAR*D is but one example Taskforce, 2006; Sackett, Rosenberg,database may serve as the best resource. that demonstrates the need for Gray, Haynes, & Richardson, 1996). straightforward reporting of the The proposed higher standard ofA higher standard of clinical trial evidence so that physicians care aligns the prescriber with thepsychotropic prescriptive care can discern science from spin and draw patient, the evidence, and the outcome• Prescribers should secure patient their own conclusions. The STAR*D of intervention, and perhaps more informed consent after full investigators posited a 67% cumulative importantly, the commitment to disclosure of the risks and benefits remission rate but qualified that the first ‘ do no harm’ (Smith, 2005). We of psychotropic prescription estimate: ‘… assumes no dropouts, and believe that a careful reading of the (Cohen & Jacobs, 2000). it assumes that those who exited the study six rights identified in this article will• Psychosocial options, including would have had the same remission as reveal them to reflect a scientifically psychotherapy, should be tried those who stayed in the protocol’ (Rush supported, common sense, practical, first consistent with patient et al, 2006b). As the 67% figure is and respectful approach to the use of preference. often repeated while the unrealistic psychotropic medications.• Practices that are not empirically assumptions on which it is based are supported —  off-label prescribing, forgotten, it is easy for prescribers to Acknowledgements polypharmacy (especially with conclude that augmentation/switch This article was first published in the children), dosages outside strategies have sound support. On International Journal of Clinical Medicine, recommended ranges, and 2011, 2, 353–359. Reprinted with kind the other hand, if one looks at the permission of the authors. lifetime regimens — should remission across all levels, which be limited and include full at each level was quite meager and References patient consent as well as close less than typical placebo response, Andrews, G. (2001). Should depression monitoring. combined with a 51% adverse reaction be managed as a chronic disease? British• Patient-rated measures of outcome profile after augmentation/switch, Medical Journal, 322(7283), 419–421. should be used in both research and a 58% relapse rate, a different Angell, M. (January 15, 2009). Medication and practice. conclusion would likely result (Sparkes, companies and doctors: A story of• Pharmaceutical company52 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications
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Washington: Zito, J., Safer, D., Sai, D., Gardner, J., American Psychological Association.Rush, A. J., Trivedi, M. H., Wisniewsk, Thomas, D., Coombes, P. et al. (2009).S. R., Nierenberg, A. A., Stewart, J. W., Stagnitti, M. N. (2007). Trends in the use Psychotropic medication patterns amongWarden, D. et al. (2006a). Acute and and expenditures for the therapeutic class youth in foster care. Pediatrics, 121(1),longer-term outcomes in depressed prescribed psychotherapeutic agents and 157–163. AUTHOR NOTES BARRY L. DUNCAN, Psy.D., therapist, trainer, and researcher is Director of the Heart and Soul of Change Project. He has over one hundred publications, including fifteen books addressing systematic client feedback, consumer rights and involvement, the power of relationship, and a risk/benefit analysis of psychotropic medications. Recent books are Heroic Clients, Heroic Agencies: Partners for Change (2nd ed. 2010), the Heart and Soul of Change (2nd ed., APA, 2010), and On Becoming a Better Therapist (APA, 2010). He co-developed the ORS/SRS family of measures and PCOMS. DAVID O. ANTONUCCIO, Ph.D., Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Nevada, USA, and Fielding Graduate University, Santa Barbara, USA. Comments: barrylduncan@comcast.net54 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications