The pharmaceutical industry has made it very difficult to know what the clinical trial evidence actually is regarding psychotropics. Consequently, 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. This article calls 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, we present a patient bill of rights for psychotropic prescription. We then offer guidelines to raise the bar of care equal to the available science for all prescribers of psychiatric medications.
KeywordsPsychotropicsRisk/Benefit AnalysisPatient RightsPrimary Care PhysiciansPharmaceutical Company Influence
M. N. Stagnitti, “Trends in the Use and Expenditures for the Therapeutic Class Prescribed Psychotherapeutic Agents and All Subclasses, 1997 and 2004,” Agency for Healthcare Research and Quality, Rockville, 2007. http://www.meps.ahrq.gov/mepsweb/data_files/publications/st163/stat163.pdf.
IMS Institute for Healthcare Informatics, “The Use of Medicines in the United States: Review of 2010,” IMS Institute for Healthcare Informatics, Norwalk, 2011. http://www.imshealth.com/deployedfiles/imshealth/Global/Content/IMS%20Institute/Static%20File/IHII_UseOfMed_report.pdf
M. Olfson and S. C. Marcus, “Current Trends in Outpatient Psychotherapy,” American Journal of Psychiatry, Vol. 167, 2010, pp. 1456-63. doi:10.1176/appi.ajp.2010.10040570
B. G. Case, M. Olfson, S. C. Marcus and C. Siegel, “Trends in the Inpatient Mental Health Treatment of Children and Adolescents in U. S. Community Hospitals between 1990 and 2000,” Archives of General Psychiatry, Vol. 64, No. 1, 2007, pp. 89-96. doi:10.1001/archpsyc.64.1.89
M. Angell, “Medication Companies and Doctors: A Story of Corruption,” New York Times Review of Books, 2009. http://www.nybooks.com/articles/archives/2009/jan/15/medication-companies-doctorsa-story-of-corruption/?page=1)
D. O. Antonuccio, W. G. Danton and T. M. McClanahan, “Psychology in the Prescription Era: Building a Firewall between Marketing and Science,” American Psychologist, Vol. 58, 2003, pp. 1028-1043. doi:10.1037/0003-066X.58.12.1028
D. Cohen and D. Jacobs, “A Model Consent Form for Psychiatric Drug Treatment,” Journal of Humanistic Psychology, Vol. 40, No. 1, 2000, pp. 59-64. doi:10.1177/0022167800401006
J. Sparks and B. Duncan, “Do No Harm: A Critical Risk/Benefit Analysis of Child Psychotropic Medications,” Journal of Family Psychotherapy, Vol. 19, No. 1, 2008, pp. 1-19. doi:10.1080/08975350801904072
R. Brown, D. O. Antonuccio, G. DuPaul, M. Fristad, C. King, J. Piacentini and B. Vitiello, “Childhood Mental Health Disorders: Evidence Base and Contextual Factors for Psychosocial, Psychopharmacological, and Combined Interventions,” American Psychological Association, Washington, 2008. doi:10.1037/11638-000
J. Sparks, B. Duncan, D. Cohen and D. Antonuccio, “Psychiatric Medications and Common Factors: An Evaluation of Risks and Benefits for Clinical Practice,” In: B. Duncan, S. Miller, B. Wampold and M. Hubble, Eds., The Heart and Soul of Change: Delivering What Works in Therapy, American Psychological Association, Washington, 2010, pp. 199-236. doi:10.1037/12075-007
L. E. Beutler and M. L. Malik, “Rethinking the DSM,” American Psychological Association, Washington, 2002. doi:10.1037/10456-000
M. Piasecki and D. O. Antonuccio, “The DSM Debate: Potential Harms Related to Psychiatric Diagnosis,” Bulletin of the Association of the Advancement of Philosophical Psychiatry, Vol. 17, 2010, pp. 15-18.
L. E. Beutler and M. L. Malik, “Diagnosis and Treatment Guidelines: The Example of Depression,” In: L. E. Beutler and M. L. Malik, Eds., Rethinking the DSM, American Psychological Association, Washington, 2002, pp. 252- 278. doi:10.1037/10456-010
B. L. Duncan, “On Becoming a Better Therapist,” American Psychological Association, Washington, 2010.
C. Hoge, J. Auchterlonie and C. Milliken, “Mental Health Problems, Use of Mental Health Services, and Attrition from Military Service after Returning from Deployment to Iraq or Afghanistan,” Journal of the American Medical Association, Vol. 295, No. 9, 2006, pp. 1023-1032. doi:10.1001/jama.295.9.1023
J. Cape, C. Whittington, M. Buszewicz, P. Wallace and L. Underwood, “Brief Psychological Therapies for Anxiety and Depression in Primary Care: Meta-analysis and Meta-regression,” BMC Medicine, Vol. 8, 2010, p. 38. doi:10.1186/1741-7015-8-38
D. Healy, “The Latest Mania: Selling Bipolar Disorder,” PLoS Medicine, Vol. 3, No. 4, 2006, p. 185. doi:10.1371/journal.pmed.0030185
C. Moreno, G. Laje, C. Blanco, G. Huiping, A. B. Schmidt and M. Olfson, “National Trends in the Outpatient Diagnosis and Treatment of Bipolar Disorder in Youth,” Archives of General Psychiatry, Vol. 64, No. 9, 2007, pp. 1032-1039. doi:10.1001/archpsyc.64.9.1032
D. O. Antonuccio, “Treating Depressed Children with Antidepressants: More Harm than Benefit?” Journal of Clinical Psychology in Medical Settings, Vol. 15, No. 2, 2008, pp. 92-97. doi:10.1007/s10880-008-9108-9
Treatment for Adolescents with Depression Study (TADS) Team, “Fluoxetine, Cognitive-Behavioral Therapy, and Their Combination for Adolescents with Depression,” Journal of the American Medical Association, Vol. 292, No. 7, 2004, pp. 807-820. doi:10.1001/jama.292.7.807
The TADS Team, “Treatment for Adolescents with Depression Study (TADS) Team, “Long-Term Effectiveness and Safety Outcomes,” Archives of General Psychiatry, Vol. 64, No. 10, 2007, pp. 1132-1144. doi:10.1001/archpsyc.64.10.1132
J. C. Fournier, R. J. DeRubeis, S. D. Hollon, S. Dimidjian, J. D. Amsterdam, R. C. Shelton, et al., “Antidepressant Medication Effects and Depression Severity: A Patient-level Meta-analysis,” Journal of the American Medical Association, Vol. 303, No. 1, 2007, pp. 47-53. doi:10.1001/jama.2009.1943
I. Kirsch, B. Deacon, T. Huedo-Medina, A. Scoboria, T. Moore and B. Johnson, “Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Medication Administration,” PLoS Medicine, Vol. 5, No. 2, 2008, p. 45.
G. Andrews, “Should Depression Be Managed as a Chronic Disease?” British Medical Journal, Vol. 322, No. 7283, 2001, pp. 419-421. doi:10.1136/bmj.322.7283.419
M. A. Posternak, and I. Miller I, “Untreated Short-term Course of Major Depression: A Meta-analysis of Outcomes from Studies Using Wait-list Control Groups,” Journal of Affective Disorders, Vol. 66, No. 2-3, 2001, pp. 139-146. doi:10.1016/S0165-0327(00)00304-9
B. Duncan, S. Miller, J. Sparks, G. Jackson, R. Greenberg, and K. Kinchin, “The Myth of the Magic Pill,” In: B. Duncan, S. Miller and J. Sparks, Eds., The Heroic Client, Jossey-Bass, San Francisco, 2004, pp. 147-177.
J. Lacasse and J. Leo, “Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature,” PloS Medicine, Vol. 2, No. 12, 2005, p. 392.
D. O. Antonuccio, W. G. Danton and G. DeNelsky, “Psychotherapy vs. Medication for Depression: Challenging the Conventional Wisdom with Data,” Professional Psychology, Vol. 26, No. 6, 1995, pp. 574-585.
R. J. DeRubeis, S. D. Hollon, J. D. Amsterdam, R. C. Shelton, P. R. Young, R. M. Solomon, et al., “Cognitive Therapy vs. Medications in the Treatment of Moderate to Severe Depression,” Archives of General Psychiatry, Vol. 62, 2005, pp. 409-416. doi:10.1001/archpsyc.62.4.409
S. D. Hollon, R. J. DeRubeis, R. C. Shelton, J. D. Amsterdam, R. M. Salomon, J. P. O’Reardon, et al., “Prevention of Relapse Following Cognitive Therapy vs. Medications in Moderate to Severe Depression,” Archives of General Psychiatry, Vol. 62, No. 4, 2005, 417-422.
D. O. Antonuccio, D. Burns and W. G. Danton, “Antidepressants: A Triumph of Marketing over Science?” Prevention and Treatment, Vol. 5, No. 1, 2002.
M. B. J. Blom, K. Jonker, E. Dusseldorp, P. Spinhowen, E. Hoencamp, J. Haffmans and R. van Dyck, “Combination Treatment for Acute Depression Is Superior Only When Psychotherapy Is Added to Medication,” Psychotherapy and Psychosomatics, Vol. 76, No. 5, 2007, pp. 289-297. doi:10.1159/000104705
S. Dimidjian, S. Hollon, K. Dobson, K. Schmaling, R. Kohlenberg, M. Addis, et al., “Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Acute Treatment of Adults with Major Depression,” Journal of Consulting and Clinical Psychology, Vol. 74, No. 4, 2006, pp. 658-670. doi:10.1037/0022-006X.74.4.658
K. Dobson, S. Hollon, S. Dimidjian, K. Schmaling, R. Kohlenberg, R. Gallop, et al., “Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Prevention of Relapse and Recurrence in Major Depression,” Journal of Consulting and Clinical Psychology, Vol. 76, No. 3, 2008, pp. 468-477. doi:10.1037/0022-006X.76.3.468
C. Yury, J. Fisher, D. O. Antonuccio, M. Valenstein and J. Matuszak, “Meta-analysis of Antidepressant Augmentation: Piling on in the Absence of Evidence,” Ethical Human Psychology and Psychiatry, Vol. 11, No. 3, 2009, pp. 171-182. doi:10.1891/1559-4343.11.3.171
A. J. Rush, M. H. Trived, S. R. Wisniewski, J. W. Stewart, A. A. Nierenberg, M. E. Thase, et al., “Bupropion-sr, Sertraline, or Venlafaxine-xr after Failure of SSRIs for Depression. New England Journal of Medicine, Vol. 354, No. 12, 2006, pp. 1231-1242. doi:10.1056/NEJMoa052963
M. H. Trivedi, A. J. Rush, S. R. Wisniewski, A. A. Nierenberg, D. Warden, L. Ritz, et al., “Evaluation of Outcomes with Citalopram for Depression Using Measurement-based Care in STAR*D: Implications for Clinical Practice,” American Journal of Psychiatry, Vol. 163, No. 1, 2006, pp. 28-40. doi:10.1176/appi.ajp.163.1.28
A. J. Rush, M. H. Trivedi, S. R. Wisniewsk, A. A. Nierenberg, J. W. Stewart, D. Warden, et al., “Acute and Longer-term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report,” American Journal of Psychiatry, Vol. 163, No. 5-7, 2006, pp. 1905-1917. doi:10.1176/appi.ajp.163.11.1905
M. H. Trivedi, M. Fava, S. R. Wisniewski, M. E. Thase, F. Quitkin, D. Warden, et al., “Medication Augmentation after the Failure of SSRIs for Depression,” New England Journal of Medicine, Vol. 354, No. 12, 2006, pp. 1243-1252. doi:10.1056/NEJMoa052964
J. Rush, H. Madhukar, M. Trivedi, J Stewart, A. Nierenberg, M. Fava, et al., “Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study,” American Journal of Psychiatry, Vol. 168, No. 7, 2011, pp. 689-701. doi:10.1176/appi.ajp.2011.10111645
J. A. Sparks and B. L. Duncan, “Critical Ethical Practice and Pediatric Antipsychotics,” In: S. Olfman and B. D. Robbins, Eds., Medicating Our Children, Praeger Publishers, Westport, in Press.
P. Pathak, D. West, B. C. Martin, M. E. Helm and C. Henderson, “Evidence-based Use of Second-generation Antipsychotics in a State Medicaid Pediatric Population, 2001-2005,” Psychiatric Services, Vol. 61, No. 2, 2010, pp. 123-129. doi:10.1176/appi.ps.61.2.123
S. Crystal, M. Olfson, C. Huang, H. Pincus and T. Gerhard, “Broadened Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy Challenges,” Health Affairs, Vol. 28, No. 5, 2009, pp. 770-781. doi:10.1377/hlthaff.28.5.w770
J. Zito, D. Safer, D. Sai, J. Gardner, D. Thomas, P. Coombes, et al., “Psychotropic Medication Patterns among Youth in Foster Care,” Pediatrics, Vol. 121, No. 1, 2009, pp. 157- 163. doi:10.1542/peds.2007-0212
S. Fisher and R. P. Greenberg, “From Placebo to Panacea: Putting Psychiatric Medications to the Test,” Wiley, New York, 1997.
J. A. Lieberman, T. S. Stroup, J. P. McEvoy, M. S. Swartz, R. A. Rosenheck, O. Perkins, et al., “Effectiveness of Antipsychotic Medications in Patients with Chronic Schizophrenia,” New England Journal of Medicine, Vol. 353, 2005, pp. 1209-1223. doi:10.1056/NEJMoa051688
R. Findling, J. Johnson, J. McClellan, J. Frazier, B. Vitiello, R. Hamer, et al., “Double-blind Maintenance Safety and Effectiveness Findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) Study,” Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 49, No. 6, 2010, pp. 583-594.
R. P. Greenberg, R. F. Bornstein, M. D. Greenberg and S. Fisher, “A Meta-analysis of Antidepressant Outcome under “Blinder” Conditions,” Journal of Consulting and Clinical Psychology, Vol. 60, No. 5, 1992, pp. 664-669. doi:10.1037/0022-006X.60.5.664
J. N. Jureidini, C. J. Doecke, P. R. Mansfield, M. M. Haby, D. B. Menkes and A. L. Tonkin, “Efficacy and Safety of Antidepressants for Children and Adolescents,” British Medical Journal, Vol. 328, No. 7444, 2004, pp. 879-883. doi:10.1136/bmj.328.7444.879
M. Lambert, “Yes, It Is Time for Clinicians to Routinely Monitor Treatment Outcome,” In: B. Duncan, S. Miller, B. Wampold, and M. Hubble, Eds., The Heart and Soul of Change: Delivering What Works in Therapy, American Psychological Association, Washington, 2010, pp. 239- 268. doi:10.1037/12075-008
D. O. Antonuccio, D. W. Danton, G. Y. DeNelsky, R. P. Greenberg and J. S. Gordon, “Raising Questions about Antidepressants,” Psychotherapy and Psychosomatics, Vol. 68, No. 1, 1999, pp. 3-14. doi:10.1159/000012304
I. Kirsch, T. Moore, A. Scoboria and S. Nichols, “The Emperor’s New Medications: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Medication Administration,” Prevention and Treatment, Vol. 3, 2002.
D. O. Antonuccio and D. Healy, “The Researcher’s Credo,” British Medical Journal, Vol. 336, No. 7645, 2008, p. 629. doi:10.1136/bmj.39520.521146.3A
E. H. Turner, A. M. Matthews, E. Linardatos, R. A. Tell and R. Rosenthal, “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” New England Journal of Medicine, Vol. 358, No. 3, 2008, pp. 252-260. doi:10.1056/NEJMsa065779
B. Wieseler, N. McGaura and T. Kaiser, “Finding Studies on Reboxetine: A Tale of Hide and Seek,” British Medical Journal, Vol. 341, 2010, p. 4942. doi:10.1136/bmj.c4942
H. E. Pigott, A. M. Leventhal, G. S. Alter and J. J. Boren, “Efficacy and Effectiveness of Antidepressants: Current Status of Research,” Psychotherapy and Psychosomatics, Vol. 79, No. 5, 2009, pp. 267-279. doi:10.1159/000318293
APA Presidential Task Force on Evidence-Based Practice, “Evidence-Based Practice in Psychology,” American Psy- chologist, Vol. 61, 2006, pp. 271-285.
D. L. Sackett, W. M. Rosenberg, J. A. Gray, R. B. Haynes and W. S. Richardson, “Evidence Based Medicine: What It Is and What It Isn’t,” British Medical Journal, Vol. 312, No. 7023, 1996, pp. 71-72.
C. M. Smith, “Origin and Uses of Primum Non Nocere- Above All, Do No Harm!” Journal of Clinical Pharmacology, Vol. 45, No. 4, 2005, pp. 371-377. doi:10.1177/0091270004273680