usesandmisusespsychiatricdrugs

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Keeping the Evidence in

Evidence Based Medicine

Keeping the Evidence in

Evidence Based Medicine

May 8, 2010

Barry Duncan,Barry Duncan, Psy.DPsy.D.. [email protected]@comcast.netMarciaMarcia BarbackiBarbacki [email protected]@att.net

www.heartandsoulofchange.comwww.heartandsoulofchange.com

The Use and Misuse ofPsychiatric Drugs

Your Help Is NeededYour Help Is Needed

The relationship—betweensecularism, materialism, greed,and increases in anxiety,depression, substance abuseand aggression—is ignored

Problems, instead, are located inthe person—as brain disordersor chemical imbalances

Children, the elderly, pregnantwomen are drugged as a firstline of treatment in a systemthat devalues family, Church andcommunity.

The relationship—betweensecularism, materialism, greed,and increases in anxiety,depression, substance abuseand aggression—is ignored

Problems, instead, are located inthe person—as brain disordersor chemical imbalances

Children, the elderly, pregnantwomen are drugged as a firstline of treatment in a systemthat devalues family, Church andcommunity.

Children on welfare 16 timesChildren on welfare 16 timesmore likely to be medicatedmore likely to be medicatedChildren on welfare 16 timesChildren on welfare 16 timesmore likely to be medicatedmore likely to be medicated


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Precarious PositionPhysicians

Precarious PositionPhysicians

Shocked but grateful tohave their eyes opened

Increasing litigation:side effects, birthdefects

Need access to thedata—not fromdetailers—a summaryand resource list at ourbooth

Shocked but grateful tohave their eyes opened

Increasing litigation:side effects, birthdefects

Need access to thedata—not fromdetailers—a summaryand resource list at ourbooth

Prescription PracticesStats

Prescription PracticesStats

2006: More moneyspent on treatingmental disorders inchildren than for anyother condition ($8.9B).

1996 to 2006: Useincreased by 73% foradults & 50% withchildren. Over 15 millionon drugs.

2006: More moneyspent on treatingmental disorders inchildren than for anyother condition ($8.9B).

1996 to 2006: Useincreased by 73% foradults & 50% withchildren. Over 15 millionon drugs.


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Are Increasing Rates Justifiedby Clinical Trial Evidence?

Are Increasing Rates Justifiedby 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 anantidepressant in 1996—13million people. Rose to over10% or 27 million by 2005.

Global increase: 274%. Whilepsychotropic drug use has risen,community behavioralintervention has remained flator declined.

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 anantidepressant in 1996—13million people. Rose to over10% or 27 million by 2005.

Global increase: 274%. Whilepsychotropic drug use has risen,community behavioralintervention has remained flator declined.

AntidepressantsEvidence Paints Different Picture

AntidepressantsEvidence Paints Different Picture

Only population-based study of antidepressants found that, forusers of antidepressants compared to non-users, the durationof depression episodes was longer and the number of episodeswas higher for users (Patten, 2004).

In a review of antidepressant trials involving 12,564 persons(Turner et al, 2008), 94% of published trials had favorableresults whereas the percentage of positive results for publishedand unpublished trials together drops to 51%.

Kirsch et al. (2008) meta-analytically examining all trialssubmitted to the FDA of four SSRIs found no significantdifferences between placebo and SSRIs, with the exception ofthe most distressed in the severely depressed group.

The negligible advantage of SSRIs over placebo underlines theimportance to detect their adverse effects, which aresubstantial, including youth suicidal behavior and birth defects.

Only population-based study of antidepressants found that, forusers of antidepressants compared to non-users, the durationof depression episodes was longer and the number of episodeswas higher for users (Patten, 2004).

In a review of antidepressant trials involving 12,564 persons(Turner et al, 2008), 94% of published trials had favorableresults whereas the percentage of positive results for publishedand unpublished trials together drops to 51%.

Kirsch et al. (2008) meta-analytically examining all trialssubmitted to the FDA of four SSRIs found no significantdifferences between placebo and SSRIs, with the exception ofthe most distressed in the severely depressed group.

The negligible advantage of SSRIs over placebo underlines theimportance to detect their adverse effects, which aresubstantial, including youth suicidal behavior and birth defects.


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NIMH funded Clinical Antipsychotic Trials of Intervention(CATIE) (Lieberman et al., 2005) enrolled 1,400 participants at57 US sites. CATIE sought to valuate how well SGAs(olanzapine, quetiapine, resperidonel) compared with oneanother and a FGA (perphenazine) in real world conditions.

Results confirm what many clients report anecdotally—antipsychotics do not improve general life domains and carry asignificant side effect burden. 74% discontinued before 18months, largely due to inefficacy and intolerable side effects

Psychosocial functioning improved modestly for the one third ofCATIE participants who reached the primary Quality of LifeScale 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.”

NIMH funded Clinical Antipsychotic Trials of Intervention(CATIE) (Lieberman et al., 2005) enrolled 1,400 participants at57 US sites. CATIE sought to valuate how well SGAs(olanzapine, quetiapine, resperidonel) compared with oneanother and a FGA (perphenazine) in real world conditions.

Results confirm what many clients report anecdotally—antipsychotics do not improve general life domains and carry asignificant side effect burden. 74% discontinued before 18months, largely due to inefficacy and intolerable side effects

Psychosocial functioning improved modestly for the one third ofCATIE participants who reached the primary Quality of LifeScale 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.”

AntipsychoticsEvidence Paints Different Picture

AntipsychoticsEvidence Paints Different Picture

The APA Working Group on PsychoactiveMedications for Children and AdolescentsThe APA Working Group on PsychoactiveMedications for Children and Adolescents

For most of the disorders reviewed herein,there are psychosocial treatments that aresolidly grounded in empirical support as stand-alone treatments. Moreover, the preponderanceof available evidence indicates thatpsychosocial treatments are safer thanpsychoactive medications. Thus, it is ourrecommendation that in most cases,psychosocial interventions be consideredfirst. (p. 16.)

For most of the disorders reviewed herein,there are psychosocial treatments that aresolidly grounded in empirical support as stand-alone treatments. Moreover, the preponderanceof available evidence indicates thatpsychosocial treatments are safer thanpsychoactive medications. Thus, it is ourrecommendation that in most cases,psychosocial interventions be consideredfirst. (p. 16.)


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Psychiatric DrugsThe Risks That Don’t Make the Ads

Psychiatric DrugsThe Risks That Don’t Make the Ads

Antidepressant Risks: Manic behaviors—5times the rate of placebo; ‘Warning’ forsuicidal behavior—twice the rate ofplacebo; withdrawal; birth defects; stuntedgrowth—Only 3 of 15 studies show drugsslightly better than a sugar pill

Stimulant Risks: ‘Warnings’ for cardiacsudden death, & suicide; Stunts growth 1cm and 2 kg per yr; Mania, psychosis,addiction; 64% report adverse reactions;NO long-term safety data or evidence ofeffectiveness

Antipsychotic Risks: Diabetes,, obesity;obesity;tardive dyskinesia, neuroleptic malignantardive dyskinesia, neuroleptic malignantsyndrome,syndrome, suicide, akathisia,, akathisia, earlydeath—NO scientific escientific evidence supportingeffectiveness

Antidepressant Risks: Manic behaviors—5times the rate of placebo; ‘Warning’ forsuicidal behavior—twice the rate ofplacebo; withdrawal; birth defects; stuntedgrowth—Only 3 of 15 studies show drugsslightly better than a sugar pill

Stimulant Risks: ‘Warnings’ for cardiacsudden death, & suicide; Stunts growth 1cm and 2 kg per yr; Mania, psychosis,addiction; 64% report adverse reactions;NO long-term safety data or evidence ofeffectiveness

Antipsychotic Risks: Diabetes,, obesity;obesity;tardive dyskinesia, neuroleptic malignantardive dyskinesia, neuroleptic malignantsyndrome,syndrome, suicide, akathisia,, akathisia, earlydeath—NO scientific escientific evidence supportingeffectiveness

A risk/benefit analysisA risk/benefit analysisdoes not support drugsdoes not support drugsas a 1as a 1stst line treatment.line treatment.

A risk/benefit analysisA risk/benefit analysisdoes not support drugsdoes not support drugsas a 1as a 1stst line treatment.line treatment.

Sparks, Duncan, Cohen, & Antonuccio,Fatal Flaws to Watch For

Sparks, Duncan, Cohen, & Antonuccio,Fatal Flaws to Watch For

Given the infiltration ofindustry influence,discerning good sciencefrom good marketingrequires a willingness toengage primary sources

Flaws cast doubt on claimsthat medication should be afirst line, a priori solution toany client problem.

Given the infiltration ofindustry influence,discerning good sciencefrom good marketingrequires a willingness toengage primary sources

Flaws cast doubt on claimsthat medication should be afirst line, a priori solution toany client problem.


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5 Fatal Flaws of Drug Studies#1 Compromised Blind

5 Fatal Flaws of Drug Studies#1 Compromised Blind

Double Blind: foundationof the RCT

Inactive placebos make itpossible to know tx status(side effects)

Many experienced withmeds, & many activelyseek to know their status

Double blind integrity notmonitored

Double Blind: foundationof the RCT

Inactive placebos make itpossible to know tx status(side effects)

Many experienced withmeds, & many activelyseek to know their status

Double blind integrity notmonitored

5 Fatal Flaws of Drug Studies#2 Client versus Clinician Ratings

5 Fatal Flaws of Drug Studies#2 Client versus Clinician Ratings

Clients & clinicians differ onimpressions of improvement

Outcome measures are mostoften clinician-rated

When client ratings areused, no difference results

If clients don’t know they’rebetter, how much better arethey? Can know via the ORS

Clients & clinicians differ onimpressions of improvement

Outcome measures are mostoften clinician-rated

When client ratings areused, no difference results

If clients don’t know they’rebetter, how much better arethey? Can know via the ORS

YouYou areare feeling better!feeling better!


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5 Fatal Flaws of Drug Studies#3 Time of Measurement

5 Fatal Flaws of Drug Studies#3 Time of Measurement

Medications are neverprescribed for shortperiods of time

8-12 week trialsinadequately determineeffect; differences startto dissolve by 16 weeks

Drug trial time frames:logistics or strategy?

Medications are neverprescribed for shortperiods of time

8-12 week trialsinadequately determineeffect; differences startto dissolve by 16 weeks

Drug trial time frames:logistics or strategy?

One study of every publicly availabletrial funded by the pharmaceuticalindustry pitting five new antipsychoticdrugs against one another, nine in 10showed that the best drug was theone made by the company funding thestudy.

"On the basis of these contrasting findings in head"On the basis of these contrasting findings in head--toto--head trials, it appears that whichever companyhead trials, it appears that whichever companysponsors the trial produces the better antipsychoticsponsors the trial produces the better antipsychoticdrug," Davis, American Journal of Psychiatry.drug," Davis, American Journal of Psychiatry.

5 Fatal Flaws of Drug Studies#4 Conflicts of Interest

5 Fatal Flaws of Drug Studies#4 Conflicts of Interest


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5 Fatal Flaws of Drug Studies#5 Minimization of Risks

5 Fatal Flaws of Drug Studies#5 Minimization of Risks

Lack of standardizedmeasures for adverseevents; mostly fromspontaneous report

Lack of clarity of AEterminology

Failure to publishunfavorable studies

Rhetoric obscures data Conclusions for tolerability

and safety do not reflectfindings

Lack of standardizedmeasures for adverseevents; mostly fromspontaneous report

Lack of clarity of AEterminology

Failure to publishunfavorable studies

Rhetoric obscures data Conclusions for tolerability

and safety do not reflectfindings

This won’t hurt a bitThis won’t hurt a bit

Flaws in Action: TADS(Treatment of Adolescent Depression Study)

Flaws in Action: TADS(Treatment of Adolescent Depression Study)

Multicenter, randomized,masked, effectiveness trialfunded by NIMH. N=432

Short term (12-weeks) &long-term (36-weeks) ofadols. diagnosed w/MDD

4 groups: Prozac, placebo,CBT, Prozac + CBT

Primary measures: CDRSand dichotomized CGI-I

Multicenter, randomized,masked, effectiveness trialfunded by NIMH. N=432

Short term (12-weeks) &long-term (36-weeks) ofadols. diagnosed w/MDD

4 groups: Prozac, placebo,CBT, Prozac + CBT

Primary measures: CDRSand dichotomized CGI-I


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. . . a landmark government. . . a landmark government--financed study has found that Prozac helps teenagersfinanced study has found that Prozac helps teenagersovercome depression far better than talk therapy. But a combination of the two treatments,overcome depression far better than talk therapy. But a combination of the two treatments,the study found, produced the best result.the study found, produced the best result. NY Times, June 2, 2004NY Times, June 2, 2004

"The medication is addressing"The medication is addressingthe chemical imbalances in thethe chemical imbalances in thebrain while the psychotherapy isbrain while the psychotherapy isaddressing the behavior and theaddressing the behavior and thethoughts," said Dr. Timothythoughts," said Dr. TimothyWilens, a child psychiatrist atWilens, a child psychiatrist atMassachusetts General Hospital,Massachusetts General Hospital,who reviewed some of thewho reviewed some of thepreliminary results for ABCpreliminary results for ABCNews.News.

"The take"The take--home message ishome message isthat medication works, thatthat medication works, thatsuicide risk is minimal andsuicide risk is minimal andthat the positive effects of thethat the positive effects of themedicine outweigh the risk,"medicine outweigh the risk,"said Koplewicz. ABC News,said Koplewicz. ABC News,June 2June 2

Prozac effectiveProzac effective

The study's findings so far indicate that patientsThe study's findings so far indicate that patientsbecame less suicidal as the study advanced,became less suicidal as the study advanced,Emslie said in an interview. Nevertheless, theEmslie said in an interview. Nevertheless, therisk of suicide attempts was greater among thoserisk of suicide attempts was greater among thosetaking Prozac than those on placebo or talktaking Prozac than those on placebo or talktherapy: Five people on Prozac and one ontherapy: Five people on Prozac and one onplacebo made a suicide attempt, he said. Heplacebo made a suicide attempt, he said. Headded that the number of patients in the studyadded that the number of patients in the studywas too small to establish whether an increasedwas too small to establish whether an increasedrisk actually exists.risk actually exists. Newsday, June 3, 2004Newsday, June 3, 2004

"This study will help"This study will helpput the argument toput the argument torest," Emslie said.rest," Emslie said.

TADSA Tad Short on Evidence


Flaw #1: No active placebo; Noplacebo comparison for Comb.; CBTand Comb. knew tx status (nodifference with placebo).

Flaw #2: Primary measures clinician-rated. Secondary measures havelimited psychometric credibility. 1 of 2clinician-rated scales (CGI-I) at 12-weeks shows difference. Primarymeasure shows no difference. Noeffects on client measures

Flaw #3: 12-week trial with limitedmasking; beyond 12 weeks, allparticipants knew treatment status.No difference at 30 weeks

Flaw #1: No active placebo; Noplacebo comparison for Comb.; CBTand Comb. knew tx status (nodifference with placebo).

Flaw #2: Primary measures clinician-rated. Secondary measures havelimited psychometric credibility. 1 of 2clinician-rated scales (CGI-I) at 12-weeks shows difference. Primarymeasure shows no difference. Noeffects on client measures

Flaw #3: 12-week trial with limitedmasking; beyond 12 weeks, allparticipants knew treatment status.No difference at 30 weeks


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Flaw # 4: Leadinvestigator, John March:support from Eli Lilly–extensive ties; Emslie andother researcher:consultants, speakersbureau, and researchsupport from Eli Lilly.

Flaw # 5: 6 suicideattempts out of 200 Prozactakers compared with 1 outof 200 non-Prozac takers.

ConclusionsThe Evidence Speaks the Truth

ConclusionsThe Evidence Speaks the Truth

When clinical trials are criticallyexamined…the evidence doesnot support drug treatments asa first line of treatment.

Knowing that there is nocompelling evidence tomedicate, providers are free todiscuss the risks/benefits &other alternatives: Church,community, counseling to helpfamilies choose txs in concert w/values, culture, & preferences.

When clinical trials are criticallyexamined…the evidence doesnot support drug treatments asa first line of treatment.

Knowing that there is nocompelling evidence tomedicate, providers are free todiscuss the risks/benefits &other alternatives: Church,community, counseling to helpfamilies choose txs in concert w/values, culture, & preferences.

Bottom Line:

Look at the

evidence

yourself and

draw your own

conclusions


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Our Proposal:Help FIAMC Protect Human Life

Our Proposal:Help FIAMC Protect Human Life

Support a conference, whichcan impact policy by:

Sharing accurate data andproviding solutions at multiplelevels that value family andChurch, and promote ethicalresearch in health care

Educating health/pastoral careprofessionals to haverisk/benefit discussions withfamilies, clients, communities

Preventing global spread ofpractices that are not evidencebased but greed motivated.

Support a conference, whichcan impact policy by:

Sharing accurate data andproviding solutions at multiplelevels that value family andChurch, and promote ethicalresearch in health care

Educating health/pastoral careprofessionals to haverisk/benefit discussions withfamilies, clients, communities

Preventing global spread ofpractices that are not evidencebased but greed motivated.

Pope Benedict XVI, Nov., 2006Pope Benedict XVI, Nov., 2006

“Scientific predictability also raises thequestion of the scientists’ ethicalresponsibilities. His conclusions must beguided by respect for the truth & honestacknowledgement of both the accuracy &the inevitable limitations of the scientificmethod. Certainly this means avoidingneedlessly alarming predictions whenthese are not supported by sufficient dataor exceeds science’s actual ability topredict. But it also means avoidingthe opposite, namely a silence bornof fear, in the face of genuineproblems. The influence of scientists inshaping public opinion is too important tobe undermined by undue haste or thepursuit of superficial publicity.”

“Scientific predictability also raises thequestion of the scientists’ ethicalresponsibilities. His conclusions must beguided by respect for the truth & honestacknowledgement of both the accuracy &the inevitable limitations of the scientificmethod. Certainly this means avoidingneedlessly alarming predictions whenthese are not supported by sufficient dataor exceeds science’s actual ability topredict. But it also means avoidingthe opposite, namely a silence bornof fear, in the face of genuineproblems. The influence of scientists inshaping public opinion is too important tobe undermined by undue haste or thepursuit of superficial publicity.”

usesandmisusespsychiatricdrugs

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