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A patient bill of rights for psychotropic
prescription: A call for a higher standard
of care
BARRY 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 by
the 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 of
as the transition of behavioural health       picture of the trial data. Marcia            any arena involving information
to primary care venues, spending for          Angell, former editor of the New             about medications that does not have
psychiatric medications in the US             England Journal of Medicine concludes:       significant industry financial or
increased from nearly $8 billion in               ‘It is simply no longer possible to      marketing influences.’ (p. 1030). Given
1997 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 be
Informatics, 2011).1 Concurrently,            medical guidelines. I take no pleasure in    misleading as a basis for sound clinical
the 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 line
has fallen or remained flat (Case,            Medicine’ (Angell, 2009).                    practitioners often do not have the
Olfson, 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 trial
clinical trial evidence? Unfortunately,       practices extends to the Internet,           literature, or to know the range of
                                              print, and broadcast media, direct-          treatment options available to permit
1	 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.

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   Building on earlier efforts to            diagnostic view can lead to a ‘pill for       that up to 50% of patients referred for
establish patient informed consent           every ill’ prescriptive practice (Piasecki    mental health services do not make the
regarding 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 best
2008), this article calls for a higher       of how a patient’s problems impact his        that the assessment and treatment
standard of prescriptive care derived        or her life (Beutler & Malik, 2002b) and      be a part of routine care rather than
from 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 are
that many current prescribing practices
are empirically unsound and unduly
                                                  empirically unsound and unduly influenced
influenced by pharmaceutical company
interests, which tend to inflate benefits
                                                  by pharmaceutical company interests, which
and minimise risk.
   In the spirit of evidenced based
                                                   tend to inflate benefits and minimise risk.
medicine’s inclusion of patient values
as well as the movement toward               2010). Closely aligned with a health          benefits ensue. For example, a recent
health home (i.e., an approach to            home perspective and integrated care,         meta-analysis reported improvements
providing comprehensive primary              a thorough and systematic assessment          in both mental and physical health
care that emphasises physician/              gathers information from all significantly    when brief psychotherapy was
patient collaboration), we present a         involved persons and includes                 incorporated into primary care settings
patient 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 introduced
by James Madison to the First U.S.
Congress in 1789. The Bill of Rights
limits the power of the U.S. Federal
Government, protecting the natural
rights of liberty and property, including
freedom of speech, free press, free
assembly, and freedom from cruel and
unusual punishment.
   This article proposes a bill of rights
designed to preserve the autonomy and
freedom of patients who are prescribed
psychotropic drugs in the hopes of
creating an evolving document and
ongoing discussion of this critical issue.
Guidelines to raise the bar of care
equal to the available science for all
prescribers of psychiatric medications
are offered.
A patient bill of rights for
psychotropic prescription

1. Patients have a right to a
thorough diagnostic and functional
assessment by a behavioural
health care specialist
   While diagnosis is critical to
providing evidence-based medical
treatment, diagnosis in behavioural
healthcare arising from the Diagnostic
and Statistical Manual of the American
Psychiatric Association has notoriously
poor reliability and validity (Beutler
& Malik, 2002a). An over-reliance
on this descriptive, symptom-based
                                                                                 Photo: © Savina Hopkins, 2013. www.savinahopkins.com

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   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 treated
in question may be best described            groups had significantly more              by a physician who sees psychosocial
as part of the human condition or a          psychiatric adverse events; six suicide    options as viable first line, stand alone
natural 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, problem
or in other words, the right not to          group (Sparks, Duncan, Cohen &             solving, community, spiritual, and peer
have normal behaviour labelled               Antonuccio, 2010; Antonuccio, 2008;        options) for emotional and behavioural
as pathological. Pharmaceutical              Treatment for Adolescents with             problems. For example, in the case of
marketing has led to what has been           Depression Study, 2004; Treatment for      depression, contrary to conventional
called ‘ disease mongering, or the           Adolescents with Depression Study,         wisdom, psychological treatments
creation or expansion of disorders to        2007). Similarly, patients should be       have been shown to be as effective as
increase 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 the
study 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 if
disorder 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; Hollon
Laje, Blanco, Huiping, Schmidt &             Paradoxically, despite the growing         et al, 2005). Combined treatments
Olfson, 2007). Investigators found           evidence of the minimal therapeutic        have not consistently fared better
a 40-fold increase in visits for this        effects of antidepressants, sales          than psychological treatments alone
diagnosis, a questionable increase           for them increased in 2010 in the          over long-term outcome, but they
despite the ostensible explanation of        US (IMS Institute for Healthcare           have tended to have better results
advances in detection of a heretofore        Informatics, 2011). Concomitant to a       than medication treatment alone
undetected 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 exposed
approximately one half given an              intervention. With depresssion, for
                                                                                        to the lowest risk of adverse events
antipsychotic and one third given an         example, spontaneous remission ranges
                                                                                        from psychotropic medications — a
anticonvulsant. 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 any
than one medication, and only four              As part of a risk/benefit discussion,   scientific studies addressing the
out of ten received psychotherapy. A         patients also should be informed that      combination of more than two
thorough 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 be
2. 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 evidence
efficacy of treatment options                                                           and when they have, underwhelming
                                             that any psychotropic medications
including psychological                                                                 results seem the norm. For example,
                                             repair chemical imbalances or other
treatment alone, medication                                                             ‘treatment resistant depression’
                                             proposed neurochemical substrates of
alone, psychological treatment                                                          prompted the STAR*D (Sequenced
                                             disorders (e.g., Lacasse & Leo, 2005).
combined with medication,                                                               Treatment Alternatives to Relieve
                                             Understanding the limits of scientific
as 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 medication
intervention should be transparently         options.                                   switching strategies for depresssion
discussed. Such open discussions                                                        when a traditional regimen of a single
allow patients to decide which               3. Patients have a right to be treated     SSRI failed (Rush et al, 2006b). The
treatment offers the best option in line     with psychosocial interventions            average remission rate (which was less
with 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 measure
For example, parents of children             evidence regarding the efficacy and        was 28% (Level 1 — initial regimen
struggling with depresssion can be           safety of psychiatric medications, a       of a single SSRI) and 25% (Level
shown 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 at
alone or in combination. CBT alone           (Brown et al, 2008; Sparks, Duncan,        both levels together out of a total of


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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 (Trivedi
et al, 2006b) and 51% at Level 2 (Rush
et al, 2006a; Trivedi et al, 2006a).
In addition, overall results from the
large scale Combining Medications to
Enhance Depression Outcomes (CO-
MED) (Rush et al, 2011) study showed
that a single antidepressant produced
the same remission rate as combined
antidepressants and that therapy with
two medications resulted in more
adverse events.
   Prescribing psychotropics
without FDA or other governing
body approval, so called off-label
prescribing 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 lack
prescriptions of psychotropics tend to
                                           controlled investigations beyond 12         of endorsement of efficacy by patients
expose 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 advantage
increasingly popular, particularly in
                                           When longer trials are done, results        over placebo, how significant can the
vulnerable 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 measures
2010; Sparks & Duncan, 2012). For
                                           who responded through the four levels       of treatment response not only in
example, a study of 11,700 youth
                                           relapsed at one year follow-up (Rush et     clinical trials but also in practice
covered by Medicaid (US) found that
                                           al, 2006a). In a large scale invetigation   will allow more accurate assessment
the number of children newly treated
                                           of antipsychotics with adults with          of medication benefit and may even
with antipsychotics increased from
                                           schizophrenia, 74% of participants          improve outcomes. Incorporating
1482 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 to
2010). This means that 26% of these
                                           effects (Lieberman et al, 2005). Finally,   significantly improve outcomes in
youth were taking antipsychotics
                                           a study of antipsychotics with youth        psychotherapy, allowing the clinician
in 2005, suggesting many off-label
                                           diagnosed with schizophrenia reported       to tailor intervention based upon
prescriptions. 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 treatment
prescribed antipsychotics at a rate four
                                           (Findling et al, 2010). Long-term use       outcomes would allow patients to
times higher than children with private
                                           of psychotropics does not appear to be      change treatment approaches if any
insurance, were more likely to receive
                                           empirically supported.                      given treatment was not working after
antipsychotics 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, patients
medications (Crystal, Olfson, Huang,       their treatment response with
                                                                                       also have a right not to have their
Pincus, & Gerhard, 2009), despite the      patient-rated outcome measures.
                                                                                       dosage increased. There appears to be
fact that not one randomised clinical         Clinicians and patients often differ     a weak dose response relationship with
trial to our knowledge has examined        substantially in their judgement of         psychotropic medications. Response
polypharmaceutical intervention with       improvement in clinical trials (Zito        does not typically improve with
children. Poor children, apparently,       et al, 2009). A metaanalysis of 22          doses higher than those already in
are 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 antidepressants
therapy.                                   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 risk
Most of the scientific psychiatric         Fisher, 1992). This is the rule rather      of adverse events significantly
database consists of controlled studies    than the exception (Treatment for           increase with higher doses. Finally,

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patients 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 perspective
given that augmentation studies have                benefits of psychotropics,             reveals that after a year of continuation
shown limited benefits. In other words,             independent of industry influence,     treatment following remission, of
patients have a right to experience a               should be available to prescribers     the 4041 patients who entered the
medication free period to see if they               and patients.                          program only 108 (3%) had a sustained
feel better before a new medication is                                                     remission — all the other patients
                                              Conclusions
added.                                                                                     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 the
scientific data conveyed in a                 address inherent flaws: analysis to          pharmaceutical industry that targets all
consumer friendly way regarding               detect penetration of the double             players in health care forms the basis
psychotropic 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 some
accessible 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 from
straightforward presentation of the           without pharmaceutical company               a safer intervention with comparable
risks and benefits free of spin and           affiliations; and independent reporting      efficacy — psychotherapy, as well as
marketing (Antonuccio & Healy,                of the findings to remove marketing          other community-based, culturally
2008). Unfortunately, our scientific          spin. Regarding practice, untainted          sensitive options. Additionally, it
database appears to be distorted by           information should be made available         promotes prescriptive treatments of
ghost written articles and skewed             to prescribers of psychotropics.             questionable sustainability, fraught
by 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 patient
pharmaceutical industry products              representatives should include               bill of rights and psychotropic
(Turner, Matthews, Linardatos,                independent evaluation of claims             prescription guidelines that embody
Tell, & Rosenthal, 2008; Wieseler,            as well as non-medication options.           a higher standard of care, making
McGaura, & Kaiser, 2010), sometimes           Incentives and benefits to prescribers       the patient a partner in the selection
recasting unfavourable outcomes into          should be eliminated. Psychosocial           and administration of treatment.
the conclusion that the medication            interventions have neither marketing         Such a collaboration allows the
is ‘efficacious, safe, and well-tolerated’.   representatives nor budgets and              integration of the best research
Until an unvarnished database that            therefore a more concerted effort to         evidence with clinical expertise and
includes all the data (including raw          include them is needed.                      patient values (APA Presidential
data) 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 of
A higher standard of
                                              clinical trial evidence so that physicians   care aligns the prescriber with the
psychotropic 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
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  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.net

54         PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013

                                                   Copyright © 2013, PsychOz Publications

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PatientBillofRightsAU

  • 1. www.psychotherapy.com.au A patient bill of rights for psychotropic prescription: A call for a higher standard of care BARRY 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 by the 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 of as the transition of behavioural health picture of the trial data. Marcia any arena involving information to primary care venues, spending for Angell, former editor of the New about medications that does not have psychiatric medications in the US England Journal of Medicine concludes: significant industry financial or increased from nearly $8 billion in ‘It is simply no longer possible to marketing influences.’ (p. 1030). Given 1997 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 be Informatics, 2011).1 Concurrently, medical guidelines. I take no pleasure in misleading as a basis for sound clinical the 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 line has fallen or remained flat (Case, Medicine’ (Angell, 2009). practitioners often do not have the Olfson, 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 trial clinical trial evidence? Unfortunately, practices extends to the Internet, literature, or to know the range of print, and broadcast media, direct- treatment options available to permit 1 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. www.psychotherapy.com.au Building on earlier efforts to diagnostic view can lead to a ‘pill for that up to 50% of patients referred for establish patient informed consent every ill’ prescriptive practice (Piasecki mental health services do not make the regarding 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 best 2008), this article calls for a higher of how a patient’s problems impact his that the assessment and treatment standard of prescriptive care derived or her life (Beutler & Malik, 2002b) and be a part of routine care rather than from 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 are that many current prescribing practices are empirically unsound and unduly empirically unsound and unduly influenced influenced by pharmaceutical company interests, which tend to inflate benefits by pharmaceutical company interests, which and minimise risk. In the spirit of evidenced based tend to inflate benefits and minimise risk. medicine’s inclusion of patient values as well as the movement toward 2010). Closely aligned with a health benefits ensue. For example, a recent health home (i.e., an approach to home perspective and integrated care, meta-analysis reported improvements providing comprehensive primary a thorough and systematic assessment in both mental and physical health care that emphasises physician/ gathers information from all significantly when brief psychotherapy was patient collaboration), we present a involved persons and includes incorporated into primary care settings patient 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 introduced by James Madison to the First U.S. Congress in 1789. The Bill of Rights limits the power of the U.S. Federal Government, protecting the natural rights of liberty and property, including freedom of speech, free press, free assembly, and freedom from cruel and unusual punishment. This article proposes a bill of rights designed to preserve the autonomy and freedom of patients who are prescribed psychotropic drugs in the hopes of creating an evolving document and ongoing discussion of this critical issue. Guidelines to raise the bar of care equal to the available science for all prescribers of psychiatric medications are offered. A patient bill of rights for psychotropic prescription 1. Patients have a right to a thorough diagnostic and functional assessment by a behavioural health care specialist While diagnosis is critical to providing evidence-based medical treatment, diagnosis in behavioural healthcare arising from the Diagnostic and Statistical Manual of the American Psychiatric Association has notoriously poor reliability and validity (Beutler & Malik, 2002a). An over-reliance on this descriptive, symptom-based Photo: © Savina Hopkins, 2013. www.savinahopkins.com PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 49 Copyright © 2013, PsychOz Publications
  • 3. www.psychotherapy.com.au 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 treated in question may be best described groups had significantly more by a physician who sees psychosocial as part of the human condition or a psychiatric adverse events; six suicide options as viable first line, stand alone natural 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, problem or in other words, the right not to group (Sparks, Duncan, Cohen & solving, community, spiritual, and peer have normal behaviour labelled Antonuccio, 2010; Antonuccio, 2008; options) for emotional and behavioural as pathological. Pharmaceutical Treatment for Adolescents with problems. For example, in the case of marketing has led to what has been Depression Study, 2004; Treatment for depression, contrary to conventional called ‘ disease mongering, or the Adolescents with Depression Study, wisdom, psychological treatments creation or expansion of disorders to 2007). Similarly, patients should be have been shown to be as effective as increase 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 the study 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 if disorder 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; Hollon Laje, Blanco, Huiping, Schmidt & Paradoxically, despite the growing et al, 2005). Combined treatments Olfson, 2007). Investigators found evidence of the minimal therapeutic have not consistently fared better a 40-fold increase in visits for this effects of antidepressants, sales than psychological treatments alone diagnosis, a questionable increase for them increased in 2010 in the over long-term outcome, but they despite the ostensible explanation of US (IMS Institute for Healthcare have tended to have better results advances in detection of a heretofore Informatics, 2011). Concomitant to a than medication treatment alone undetected 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 exposed approximately one half given an intervention. With depresssion, for to the lowest risk of adverse events antipsychotic and one third given an example, spontaneous remission ranges from psychotropic medications — a anticonvulsant. 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 any than one medication, and only four As part of a risk/benefit discussion, scientific studies addressing the out of ten received psychotherapy. A patients also should be informed that combination of more than two thorough 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 be 2. 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 evidence efficacy of treatment options and when they have, underwhelming that any psychotropic medications including psychological results seem the norm. For example, repair chemical imbalances or other treatment alone, medication ‘treatment resistant depression’ proposed neurochemical substrates of alone, psychological treatment prompted the STAR*D (Sequenced disorders (e.g., Lacasse & Leo, 2005). combined with medication, Treatment Alternatives to Relieve Understanding the limits of scientific as 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 medication intervention should be transparently options. switching strategies for depresssion discussed. Such open discussions when a traditional regimen of a single allow patients to decide which 3. Patients have a right to be treated SSRI failed (Rush et al, 2006b). The treatment offers the best option in line with psychosocial interventions average remission rate (which was less with 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 measure For example, parents of children evidence regarding the efficacy and was 28% (Level 1 — initial regimen struggling with depresssion can be safety of psychiatric medications, a of a single SSRI) and 25% (Level shown 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 at alone or in combination. CBT alone (Brown et al, 2008; Sparks, Duncan, both levels together out of a total of 50 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications
  • 4. www.psychotherapy.com.au 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 (Trivedi et al, 2006b) and 51% at Level 2 (Rush et al, 2006a; Trivedi et al, 2006a). In addition, overall results from the large scale Combining Medications to Enhance Depression Outcomes (CO- MED) (Rush et al, 2011) study showed that a single antidepressant produced the same remission rate as combined antidepressants and that therapy with two medications resulted in more adverse events. Prescribing psychotropics without FDA or other governing body approval, so called off-label prescribing 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 lack prescriptions of psychotropics tend to controlled investigations beyond 12 of endorsement of efficacy by patients expose 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 advantage increasingly popular, particularly in When longer trials are done, results over placebo, how significant can the vulnerable 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 measures 2010; Sparks & Duncan, 2012). For who responded through the four levels of treatment response not only in example, a study of 11,700 youth relapsed at one year follow-up (Rush et clinical trials but also in practice covered by Medicaid (US) found that al, 2006a). In a large scale invetigation will allow more accurate assessment the number of children newly treated of antipsychotics with adults with of medication benefit and may even with antipsychotics increased from schizophrenia, 74% of participants improve outcomes. Incorporating 1482 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 to 2010). This means that 26% of these effects (Lieberman et al, 2005). Finally, significantly improve outcomes in youth were taking antipsychotics a study of antipsychotics with youth psychotherapy, allowing the clinician in 2005, suggesting many off-label diagnosed with schizophrenia reported to tailor intervention based upon prescriptions. 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 treatment prescribed antipsychotics at a rate four (Findling et al, 2010). Long-term use outcomes would allow patients to times higher than children with private of psychotropics does not appear to be change treatment approaches if any insurance, were more likely to receive empirically supported. given treatment was not working after antipsychotics 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, patients medications (Crystal, Olfson, Huang, their treatment response with also have a right not to have their Pincus, & Gerhard, 2009), despite the patient-rated outcome measures. dosage increased. There appears to be fact that not one randomised clinical Clinicians and patients often differ a weak dose response relationship with trial to our knowledge has examined substantially in their judgement of psychotropic medications. Response polypharmaceutical intervention with improvement in clinical trials (Zito does not typically improve with children. Poor children, apparently, et al, 2009). A metaanalysis of 22 doses higher than those already in are 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 antidepressants therapy. 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 risk Most of the scientific psychiatric Fisher, 1992). This is the rule rather of adverse events significantly database 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. www.psychotherapy.com.au patients 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 perspective given that augmentation studies have benefits of psychotropics, reveals that after a year of continuation shown limited benefits. In other words, independent of industry influence, treatment following remission, of patients have a right to experience a should be available to prescribers the 4041 patients who entered the medication free period to see if they and patients. program only 108 (3%) had a sustained feel better before a new medication is remission — all the other patients Conclusions added. 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 the scientific data conveyed in a address inherent flaws: analysis to pharmaceutical industry that targets all consumer friendly way regarding detect penetration of the double players in health care forms the basis psychotropic 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 some accessible 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 from straightforward presentation of the without pharmaceutical company a safer intervention with comparable risks and benefits free of spin and affiliations; and independent reporting efficacy — psychotherapy, as well as marketing (Antonuccio & Healy, of the findings to remove marketing other community-based, culturally 2008). Unfortunately, our scientific spin. Regarding practice, untainted sensitive options. Additionally, it database appears to be distorted by information should be made available promotes prescriptive treatments of ghost written articles and skewed to prescribers of psychotropics. questionable sustainability, fraught by 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 patient pharmaceutical industry products representatives should include bill of rights and psychotropic (Turner, Matthews, Linardatos, independent evaluation of claims prescription guidelines that embody Tell, & Rosenthal, 2008; Wieseler, as well as non-medication options. a higher standard of care, making McGaura, & Kaiser, 2010), sometimes Incentives and benefits to prescribers the patient a partner in the selection recasting unfavourable outcomes into should be eliminated. Psychosocial and administration of treatment. the conclusion that the medication interventions have neither marketing Such a collaboration allows the is ‘efficacious, safe, and well-tolerated’. representatives nor budgets and integration of the best research Until an unvarnished database that therefore a more concerted effort to evidence with clinical expertise and includes all the data (including raw include them is needed. patient values (APA Presidential data) 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 of A higher standard of clinical trial evidence so that physicians care aligns the prescriber with the psychotropic 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 company 52 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications
  • 6. www.psychotherapy.com.au corruption. New York Times Review psychopharmacological, and combined treatment of early-onset schizophrenia of Books. http://www.nybooks.com/ interventions. Washington: American spectrum (TEOSS) Study. Journal of articles/archives/2009/jan/15/medication- Psychological Association. the American Academy of Child and companies-doctors-a-story-of- Adolescent Psychiatry, 49(6), 583–594. Cape, J., Whittington, C., Buszewicz, M., corruption/?page=1 Wallace, P., & Underwood, L. (2010). Brief Fisher, S., & Greenberg, R. P. (1997). From Antonuccio, D. O., Danton, W. G., & psychological therapies for anxiety and placebo to panacea: Putting psychiatric DeNelsky, G. (1995). Psychotherapy vs. depression in primary care: Meta-analysis medications to the test. New York: Wiley. medication for depression: Challenging and meta-regression. BMC Medicine, 8, 38. Fournier, J. C., DeRubeis, R. J., Hollon, the conventional wisdom with data. Case, B. G., Olfson, M., Marcus, S. C., & S. D., Dimidjian, S., Amsterdam, J. D., Professional Psychology, 26(6), 574–585. Siegel, C. (2007). Trends in the inpatient Shelton, R. C. et al. (2007). Antidepressant Antonuccio, D. O., Danton, D. W., mental health treatment of children and medication effects and depression DeNelsky, G. Y., Greenberg, R. P., & adolescents in U. S. community hospitals severity: A patient-level meta-analysis, Gordon, J. S. (1999). Raising questions between 1990 and 2000. Archives of Journal of the American Medical about antidepressants, Psychotherapy and General Psychiatry, 64(1), 89–96. Association, 303(1), 47–53. Psychosomatics, 68(1), 3–14. Cohen, D. & Jacobs, D. (2000). A Greenberg, R. P., Bornstein, R. F., Antonuccio, D. O., Burns, D. & Danton, W. model consent form for psychiatric Greenberg, M. D., & Fisher, S. (1992). A G. (2002). Antidepressants: A triumph of drug treatment. Journal of Humanistic meta-analysis of antidepressant outcome marketing over science? Prevention and Psychology, 40(1), 59–64. under blinder conditions. Journal of Treatment, 5(1). Consulting and Clinical Psychology, 60(5), Crystal, S., Olfson, M., Huang, C., Pincus, 664–669. Antonuccio, D. O., Danton, W. G., & H., & Gerhard, T. (2009). Broadened McClanahan, T. M. (2003). Psychology use of atypical antipsychotics: Safety, Healy, D. (2006). The latest mania: Selling in the prescription era: Building a firewall effectiveness, and policy challenges. bipolar disorder. PLoS Medicine, 3(4), 185. between marketing and science. American Health Affairs, 28(5), 770–781. Hoge, C., Auchterlonie, J., & Milliken, Psychologist, 58, 1028–1043. Department of Health and Ageing (2007). C. (2006). Mental health problems, use Antonuccio, D. O., & Healy, D. (2008). National mental health report 2007. of mental health services, and attrition The researcher’s credo. British Medical Australian Government. 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Miller, B. augmentation: Piling on in the absence of from studies using wait-list control groups. Wampold and M. Hubble (Eds.), The heart evidence. Ethical Human Psychology and Journal of Affective Disorders, 66(2–3), and soul of change: Delivering what works Psychiatry, 11(3), 171–182. 139–146. in therapy (pp. 199–236). 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 among Warden, 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.net 54 PSYCHOTHERAPY IN AUSTRALIA • VOL 19 NO 2 • FEBRUARY 2013 Copyright © 2013, PsychOz Publications