Lourdes FIAMC

Becoming Client Directed Keeping the Evidence in Evidence Based Medicine May 8, 2010 Barry Duncan, Psy.D. [email_address] Marcia Barbacki [email_address] www.heartandsoulofchange.com The Use and Misuse of Psychiatric Drugs

Your Help Is Needed
The relationship— between materialism, greed, & social injustice , & increases in anxiety, depression, substance abuse, and aggression—is ignored.
Suffering, instead, is addressed with a prescription.
Children, the elderly, pregnant women, and the disenfranchised are drugged as a first line of treatment in a system that devalues family, Church and community.
Children on welfare 16 times more likely to be medicated

Precarious Position Physicians
Increasing litigation: side effects, suicide, birth defects
Have not had access to clinical trial review
Need access to the data—not from detailers—available at www.heartandsoulofchange.com

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 .

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 compared to non-users, the duration of depression episodes was longer and the number of episodes was higher for users (Patten, 2004).
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.

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, resperidone) 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.”
Antipsychotics Evidence Paints Different Picture

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.)

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; t ardive dyskinesia, neuroleptic malignant syndrome, suicide , akathisia, early death —NO scientific e vidence supporting effectiveness…Nicole
A risk/benefit analysis does not support drugs as a 1 st line treatment.

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 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
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
You are feeling better!

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-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug," Davis, American Journal of Psychiatry.

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 terminology
Failure to publish unfavorable studies
Rhetoric obscures data
Conclusions for tolerability and safety do not reflect findings
This won’t hurt a bit

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

. . . a landmark government-financed study has found that Prozac helps teenagers 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 the chemical imbalances in the brain while the psychotherapy is addressing the behavior and the thoughts," said Dr. Timothy Wilens, a child psychiatrist at Massachusetts General Hospital, who reviewed some of the preliminary results for ABC News. "The take-home message is that medication works, that suicide risk is minimal and that the positive effects of the medicine outweigh the risk," said Koplewicz. ABC News, June 2 Prozac effective The study's findings so far indicate that patients became less suicidal as the study advanced, Emslie said in an interview. Nevertheless, the risk of suicide attempts was greater among those taking Prozac than those on placebo or talk therapy: Five people on Prozac and one on placebo made a suicide attempt, he said. He added that the number of patients in the study was too small to establish whether an increased risk actually exists. Newsday, June 3, 2004 "This study will help put the argument to rest," Emslie said.

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

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 not support drug treatments as a first line of treatment.
Knowing that there is no compelling evidence to medicate, providers are free to discuss the risks/benefits & other alternatives: Church, community, counseling to help families choose txs in concert w/ values, culture, & preferences.
Bottom Line: Look at the evidence yourself and draw your own conclusions

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.”

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.

Lourdes FIAMC

by Barry Duncan on May 10, 2010

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