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Barry Duncan and Marcia Barbacki's presentation at FIAMC in Lourdes to garner support of an international conference on the risks/benefits of psychotropic drugs.

Barry Duncan and Marcia Barbacki's presentation at FIAMC in Lourdes to garner support of an international conference on the risks/benefits of psychotropic drugs.



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    UsesandMisusesPsychiatricdrugs UsesandMisusesPsychiatricdrugs Document Transcript

    • www.heartandsoulofchange.com The Use and Misuse of Psychiatric Drugs Keeping the Evidence in Evidence Based Medicine Barry Duncan, Psy.D. Psy.D. barrylduncan@comcast.net Marcia Barbacki mbarbacki@att.net www.heartandsoulofchange.com May 8, 2010 Your Help Is Needed  The relationship—between secularism, materialism, greed, and increases in anxiety, depression, substance abuse and aggression—is ignored  Problems, instead, are located in the person—as brain disorders or chemical imbalances  Children, the elderly, pregnant women are drugged as a first line of treatment in a system Children on welfare 16 times more likely to be medicated that devalues family, Church and community. 1
    • www.heartandsoulofchange.com Precarious Position Physicians  Shocked but grateful to have their eyes opened  Increasing litigation: side effects, birth defects  Need access to the data—not from detailers—a summary and resource list at our booth Prescription Practices Stats  2006: More money spent on treating mental disorders in children than for any other condition ($8.9B).  1996 to 2006: Use increased by 73% for adults & 50% with children. Over 15 million on drugs. 2
    • www.heartandsoulofchange.com Are Increasing Rates Justified by Clinical Trial Evidence?  2008: sales of $40.3 billion with $14.6 billion (antipsychotics), $9.6 billion (antidepressants), $11.3 billion (antiseizures) and $4.8 billion of ADHD drugs.  About 6% were prescribed an antidepressant in 1996—13 million people. Rose to over 10% or 27 million by 2005.  Global increase: 274%. While psychotropic drug use has risen, community behavioral intervention has remained flat or declined. Antidepressants Evidence Paints Different Picture  Only population-based study of antidepressants found that, for users of antidepressants compared to non-users, the duration of depression episodes was longer and the number of episodes was higher for users (Patten, 2004).  In a review of antidepressant trials involving 12,564 persons (Turner et al, 2008), 94% of published trials had favorable results whereas the percentage of positive results for published and unpublished trials together drops to 51%.  Kirsch et al. (2008) meta-analytically examining all trials submitted to the FDA of four SSRIs found no significant differences between placebo and SSRIs, with the exception of the most distressed in the severely depressed group.  The negligible advantage of SSRIs over placebo underlines the importance to detect their adverse effects, which are substantial, including youth suicidal behavior and birth defects. 3
    • www.heartandsoulofchange.com Antipsychotics Evidence Paints Different Picture  NIMH funded Clinical Antipsychotic Trials of Intervention (CATIE) (Lieberman et al., 2005) enrolled 1,400 participants at 57 US sites. CATIE sought to valuate how well SGAs (olanzapine, quetiapine, resperidonel) compared with one another and a FGA (perphenazine) in real world conditions.  Results confirm what many clients report anecdotally— antipsychotics do not improve general life domains and carry a significant side effect burden. 74% discontinued before 18 months, largely due to inefficacy and intolerable side effects  Psychosocial functioning improved modestly for the one third of CATIE participants who reached the primary Quality of Life Scale endpoint at 12 months (Swartz et al., 2007).  Moderate to severe adverse events ranged from 42 to 69% (Zyprexa the worst) (Stroup et al., 2007).  The lead author admitted: "…the claims of superiority for [SGAs] were greatly exaggerated.” The APA Working Group on Psychoactive Medications for Children and Adolescents For most of the disorders reviewed herein, there are psychosocial treatments that are solidly grounded in empirical support as stand- alone treatments. Moreover, the preponderance of available evidence indicates that psychosocial treatments are safer than psychoactive medications. Thus, it is our recommendation that in most cases, psychosocial interventions be considered first. (p. 16.) 4
    • www.heartandsoulofchange.com Psychiatric Drugs The Risks That Don’t Make the Ads Antidepressant Risks: Manic behaviors—5 times the rate of placebo; ‘Warning’ for suicidal behavior—twice the rate of placebo; withdrawal; birth defects; stunted growth—Only 3 of 15 studies show drugs slightly better than a sugar pill Stimulant Risks: ‘Warnings’ for cardiac sudden death, & suicide; Stunts growth 1 cm and 2 kg per yr; Mania, psychosis, addiction; 64% report adverse reactions; NO long-term safety data or evidence of effectiveness Antipsychotic Risks: Diabetes, obesity; , tardive dyskinesia, neuroleptic malignant ardive A risk/benefit analysis syndrome, suicide, akathisia, early , does not support drugs death—NO scientific e evidence supporting as a 1st line treatment. effectiveness Sparks, Duncan, Cohen, & Antonuccio, Fatal Flaws to Watch For  Given the infiltration of industry influence, discerning good science from good marketing requires a willingness to engage primary sources  Flaws cast doubt on claims that medication should be a first line, a priori solution to any client problem. 5
    • www.heartandsoulofchange.com 5 Fatal Flaws of Drug Studies #1 Compromised Blind  Double Blind: foundation of the RCT  Inactive placebos make it possible to know tx status (side effects)  Many experienced with meds, & many actively seek to know their status  Double blind integrity not monitored 5 Fatal Flaws of Drug Studies #2 Client versus Clinician Ratings You are feeling better!  Clients & clinicians differ on impressions of improvement  Outcome measures are most often clinician-rated  When client ratings are used, no difference results  If clients don’t know they’re better, how much better are they? Can know via the ORS 6
    • www.heartandsoulofchange.com 5 Fatal Flaws of Drug Studies #3 Time of Measurement  Medications are never prescribed for short periods of time  8-12 week trials inadequately determine effect; differences start to dissolve by 16 weeks  Drug trial time frames: logistics or strategy? 5 Fatal Flaws of Drug Studies #4 Conflicts of Interest One study of every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study. "On the basis of these contrasting findings in head- head- to- to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug," Davis, American Journal of Psychiatry. 7
    • www.heartandsoulofchange.com 5 Fatal Flaws of Drug Studies #5 Minimization of Risks  Lack of standardized measures for adverse events; mostly from spontaneous report  Lack of clarity of AE This won’t hurt a bit terminology  Failure to publish unfavorable studies  Rhetoric obscures data  Conclusions for tolerability and safety do not reflect findings Flaws in Action: TADS (Treatment of Adolescent Depression Study)  Multicenter, randomized, masked, effectiveness trial funded by NIMH. N=432  Short term (12-weeks) & long-term (36-weeks) of adols. diagnosed w/MDD  4 groups: Prozac, placebo, CBT, Prozac + CBT  Primary measures: CDRS and dichotomized CGI-I 8
    • www.heartandsoulofchange.com . . . a landmark government-financed study has found that Prozac helps teenagers government- overcome depression far better than talk therapy. But a combination of the two treatments, the study found, produced the best result. NY Times, June 2, 2004 "The medication is addressing "This study will help the chemical imbalances in the brain while the psychotherapy is put the argument to addressing the behavior and the rest," Emslie said. thoughts," said Dr. Timothy Wilens, a child psychiatrist at Massachusetts General Hospital, who reviewed some of the Prozac effective preliminary results for ABC News. The study's findings so far indicate that patients became less suicidal as the study advanced, "The take-home message is take- Emslie said in an interview. Nevertheless, the that medication works, that risk of suicide attempts was greater among those suicide risk is minimal and taking Prozac than those on placebo or talk that the positive effects of the therapy: Five people on Prozac and one on medicine outweigh the risk," placebo made a suicide attempt, he said. He said Koplewicz. ABC News, added that the number of patients in the study June 2 was too small to establish whether an increased risk actually exists. Newsday, June 3, 2004 TADS A Tad Short on Evidence  Flaw #1: No active placebo; No placebo comparison for Comb.; CBT and Comb. knew tx status (no difference with placebo).  Flaw #2: Primary measures clinician- rated. Secondary measures have limited psychometric credibility. 1 of 2 clinician-rated scales (CGI-I) at 12- weeks shows difference. Primary measure shows no difference. No effects on client measures  Flaw #3: 12-week trial with limited masking; beyond 12 weeks, all participants knew treatment status. No difference at 30 weeks 9
    • www.heartandsoulofchange.com TADS A Tad Short on Evidence  Flaw # 4: Lead investigator, John March: support from Eli Lilly– extensive ties; Emslie and other researcher: consultants, speakers bureau, and research support from Eli Lilly.  Flaw # 5: 6 suicide attempts out of 200 Prozac takers compared with 1 out of 200 non-Prozac takers. Conclusions The Evidence Speaks the Truth  When clinical trials are critically examined…the evidence does Bottom Line: not support drug treatments as a first line of treatment. Look at the  Knowing that there is no compelling evidence to evidence medicate, providers are free to yourself and discuss the risks/benefits & other alternatives: Church, draw your own community, counseling to help families choose txs in concert w/ conclusions values, culture, & preferences. 10
    • www.heartandsoulofchange.com Our Proposal: Help FIAMC Protect Human Life Support a conference, which can impact policy by:  Sharing accurate data and providing solutions at multiple levels that value family and Church, and promote ethical research in health care  Educating health/pastoral care professionals to have risk/benefit discussions with families, clients, communities  Preventing global spread of practices that are not evidence based but greed motivated. Pope Benedict XVI, Nov., 2006 “Scientific predictability also raises the question of the scientists’ ethical responsibilities. His conclusions must be guided by respect for the truth & honest acknowledgement of both the accuracy & the inevitable limitations of the scientific method. Certainly this means avoiding needlessly alarming predictions when these are not supported by sufficient data or exceeds science’s actual ability to predict. But it also means avoiding the opposite, namely a silence born of fear, in the face of genuine problems. The influence of scientists in shaping public opinion is too important to be undermined by undue haste or the pursuit of superficial publicity.” 11