NET Topic 20040728 Clinical Use of Placebos

8/12/2019 NET Topic 20040728 Clinical Use of Placebos

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National Ethics TeleconferenceClinical Use of Placebo: An Ethics Analysis

July 28, 2004

INTRODUCTION

Dr. Berkowitz:

Good day everyone. This is Ken Berkowitz. I am the Chief of the EthicsConsultation Service at the V! "ational Center for Ethics in ealth Care and a#hysician at the V! "$ ar%or ealthcare System. I am very #leased towelcome you all to today&s "ational Ethics Teleconference. By s#onsorin' thisseries of calls( the Center #rovides an o##ortunity for re'ular education and o#endiscussion of ethical concerns relevant to V!. Each call features an educational#resentation on an interestin' ethics to#ic followed %y an o#en( moderated

discussion of that to#ic. !fter the discussion( we reserve the last few minutes ofeach call for our &from the field section&. This will %e your o##ortunity to s#eak u#and let us know what is on your mind re'ardin' ethics related to#ics other thanthe focus of today&s call.

PRESENTATION

Dr. Berkowitz:

Today)s #resentation will focus on the ethical dimensions of usin' #lace%o in

clinical care. *oinin' me on today)s call is Tim Sutton a summer ethics intern atour Center)s "ew $ork office( who recently com#leted his master)s de'ree inBioethics at Case +estern ,eserve -niversity.

The Ethics Center has received a num%er of consults from the field related to theethical issues related to the clinical use of #lace%o. ne involved a #atient wholearned that his #rescri%ed #ain medication / %ecal# / was really #lace%os#elled %ackwards. The #atient was an'ry that his #hysician deceived him( andhis relationshi# with his #hysician %roke down com#letely. !nother case involveda #hysician dece#tively usin' Tylenol as a treatment for an0iety in a difficult#atient. But we thou'ht we)d start our #resentation %y #resentin' a hy#otheticalcase that was ada#ted from a 1223 article from the *ournal of Ethics andBehavior %y Blustein et al( entitled 4Case Vi'nette5 6lace%os and InformedConsent.7 Consider 8ichael( a 9:;year;old male with chronic %ack #ain that haslimited his a%ility to work. ! neurolo'ical evaluation did not reveal any seriousa%normalities. e has had #hysical thera#y( chiro#ractic mani#ulations(acu#uncture( and a ran'e of narcotic and anti;inflammatory treatments. 8ichaelwas referred to the #ain clinic. !fter carefully e0aminin' 8ichael and reviewin'his records(


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com#le0 #ain. !lthou'h there may %e some side effects he encoura'ed the#atient to try it %ecause he %elieved it could work. The #rescri%ed su%stance wasa #lace%o.

Three weeks followin' his initial visit( 8ichael noted im#rovement in his #ain( %ut

su%se=uently learned %y searchin' +e%8< that his medication was a su'ar #illcommonly #rescri%ed as a #lace%o. >eelin' confused and %etrayed( 8ichaelnever returned to see


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r. S!tton:

Before the evolution of shared decision;makin' and informed consent #racticesover the latter half of the thcentury( truth;tellin' was not considered nearly asim#ortant as it is today. 6hysicians were trusted to make clinical decisions %ased

on the #atient)s %est interest. If they %elieved certain information mi'ht %edama'in' to a #atient( they would withhold it. If they %elieved a #lace%o wasmedically a##ro#riate( they would administer it.


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come to the clinic( his 'oals #ro%a%ly also included a dia'nostic work;u# and(ho#efully( a treatment for the cause of the #ain if #ossi%le. +alter ,o%insonar'ued in the 1223 Ethics and Behavior article that 4#atients seek hel# in anenvironment that should not only address sym#toms( %ut investi'ate theircauses( match thera#y %oth to the conditions and the #atient)s life( and e0#lore

the full meanin's of the conditions within the conte0t of the #atient)s history ande0#eriences.7 6rescri%in' a #lace%o addresses only the most su#erficial layer of#atient need. Therefore( relyin' on #lace%o %efore all other thera#euticmodalities are e0hausted is an un@ustifia%le model.

r. S!tton:

,o%inson also ar'ued that clinicians who #rescri%e a #lace%o mis#erceive their#rofessional role %y viewin' themselves as the sole source of healin'. Thischan'es the %alance in the #rovider;#atient relationshi# to the #oint where the#atient is no lon'er treated as a #artner in health care decision;makin'.

Dr. Berkowitz:

!nd if usin' a #lace%o denies #atients a real chance for dia'nosis and othertreatment that would %e unacce#ta%le.

Tim( the most common clinical use of #lace%o today is #ro%a%ly for the treatmentof #ain. Can you tell us more a%out this worrisome #ractice?

r. S!tton:

ne of the more common uses of #lace%o is as a dia'nostic tool to distin'uish%etween or'anic and functional conditions( or determine whether a #atient)s #ainis 4real.7 6ain is a multifaceted #henomenon that is( %y its very nature( su%@ective.

! #ositive #lace%o res#onse( therefore( tells nothin' a%out the cause of a#atient)s #ain( and misinter#retin' a res#onse can e0tin'uish any ho#e ofsecurin' a##ro#riate evaluation and treatment for #atients with com#le0 #ain#ro%lems. Thus( #lace%o should not %e used as an assessment tool for #ain. This#ractice is worrisome enou'h for the !merican "urses !ssociation ncolo'y"ursin' Society to develo# a s#ecific #osition statement in this area. Their#osition is sim#le( and I)ll =uote it( 4F#lace%os should not %e used in theassessment and mana'ement of cancer #ain.7

This sentiment is shared %y other or'anizations. The !merican Society for 6ain8ana'ement "ursin' has a similar #osition statement that asserts the society)sadamant o##osition to the use of #lace%o in the assessment and treatment of#ain in all #atients.

!nother fairly common misuse of #lace%o is usin' it to #lacate demandin' ornuisance #atients. This is not an advisa%le #ractice for a cou#le of reasons. >irst(

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#lace%o is a su#erficial intervention it does not address the root of a demandin'#atient)s #ro%lem. "e0t( since we know that #ain is su%@ective( the standard ofcare is to take the #atient at his or her word. There is a real dan'er of increased#atient sufferin' if the clinician incorrectly concludes the #atient is lyin' or sim#lywants attention.

Dr. Berkowitz:

Aa%elin' a #atient as malin'erin'( lyin'( dru' seekin'( attention seekin' or non;com#liant is a #itfall that all #ractitioners have to avoid.

But su##ose for a moment that the ethical hurdles of dece#tion in #rescri%in'#lace%o could %e overcome. +hat is known a%out the clinical efficacy of#lace%o?

r. S!tton:

The stron'est ar'ument for the clinical use of #lace%o is that some studies havere#orted it to %e effective( %ut many of these studies have %een criticized for theirdesi'ns. The effectiveness is 'enerally com#ared to no treatment at all( %ut somestudies re#orted that #lace%os were com#ara%le to standard thera#ies. 6lace%oshave %een re#orted to effect around H: of #atients. -nfortunately( numerousstudies to date have failed to identify any traits or characteristics indicative of aconsistent res#onder.


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r. S!tton:

This strikes at the very heart of the #lace%o de%ate. If one decided that #lace%ois an a##ro#riate treatment for a s#ecific case( then it should %e su%@ect to the

informed consent #rocess. Tellin' the #atient they are %ein' #rescri%ed amedication with no active in'redients allows the #atient to #artici#ate indece#tion;free shared decision;makin'.Dr. Berkowitz:

In 1( ro%@artsson and Gotzsche #u%lished a meta;analysis of the #lace%oeffect in the "ew En'land *ournal of 8edicine. That article( 4Is the 6lace%o6owerless(7 su''ested that the #lace%o effect is not as #owerful as some #eo#le%elieve.

In fact( ro%@artsson)s article ar'ues that there may not %e any clinical %enefit to#lace%o.

r. S!tton:

They conducted a systematic review of clinical trials in which #atients wererandomly assi'ned to either a #lace%o or no treatment. They analyzed 11J trials(H had %inary outcomes and 3 had continuous outcomes. ro%@artsson et alconcluded there is5

little evidence in 'eneral that #lace%os had #owerful clinical effects.!lthou'h #lace%os had no si'nificant effects on o%@ective or %inary

outcomes( they had #ossi%le small %enefits in studies withcontinuous su%@ective outcomes and for the treatment of #ain. Theeffect decreased with increasin' sam#le size( however( indicatin' a#ossi%le %ias related to the effects of small trials.

The researchers concluded that 4outside the settin' of clinical trials( there is no@ustification for the use of #lace%o.7

Dr. Berkowitz:

They also #ointed out that since the vast ma@ority of the studies on #lace%oefficacy were desi'ned with an a##roach that cannot distin'uish the effect of the#lace%o from the natural course of the disease. This is clinically si'nificant formany of the conditions studied nausea( asthma( #ain( etc.all tend to naturallywa0 and wane. They #ostulate that some of the re#orted effects of a #lace%omi'ht %e an artifact of this inade=uate research method.

!nother %ias that they s#eculate mi'ht %e reflected in the #lace%o literature is#u%lication %ias( that is( some trials with ne'ative outcomes mi'ht not have %een

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#u%lished. Thus( any #lace%o efficacy found on a meta;analysis mi'ht tend toover re#ort such efficacy.

!nd a'ain( the overall result of their review was that there was little evidence that#lace%os in 'eneral have #owerful clinical effects.

r. S!tton:

"ot all are convinced %y ro%@artsson)s meta;analysis( however. S#ie'el(Kraemer( and Carlson ar'ued in a su%se=uent 1 "ew En'land *ournal articlethat ro%@artsson)s conclusions do not necessarily follow from his study. Theysaid the techni=ue of meta;analysis was desi'ned for trials addressin' similar=uestions( which was not the case with the studies analyzed %y ro%@artsson.ro%@artsson used trials where the #o#ulations varied widely( influenced %ydisorders and the active treatments used. Then the collected studies wereanalyzed with 9 different outcome measures( some more relia%le than others.

Dr. Berkowitz:

So far we)ve %een talkin' a%out #lace%o as a sole thera#y. ,ecently( a literatureon the use of #lace%o as an ad@unctive thera#y has %e'un to emer'e. Can youtalk for a moment a%out this?

r. S!tton:

In a recent article( "ikola Biller !ndorno ar'ued that the #lace%o is mosta##ro#riately used in con@unction with standard thera#y( not as a re#lacement for

it. ! H clinical trial %y Sandler and Bodfish seems to su##ort his thinkin'. Thetrial e0amined the feasi%ility and #otential effectiveness of usin' #lace%os alon'with unusually low doses of stimulant medications to treat L children withattention deficit hy#eractivity disorder D!


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irst and foremost( I)d like to say that there is no way to ethically @ustify thedece#tive use of #lace%o. !ny im#ortant information that a #atient mi'ht need tomake a res#onsi%le decision a%out his or her medical care should not %ewithheld( even if withholdin' the information a##ears to %e in his or her %estinterest.


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Dr. Berkowitz:

So to sum u#( there is very little @ustification for the clinical use of #lace%o. In therare instance that a #ractitioner decides to use a #lace%o( it should never %ewithout full disclosure to the #atient.

That concludes the formal #resentation #ortion of the call. +e still have sometime for discussion so #lease feel free to introduce yourself and s#eak u#.


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%oel Roselin" National Center for Ethics in +ealth Care:

It seems to me that there can %e a confusion %etween the sense of #lace%o as a#ill( which( in the #ast( you could even write a #rescri#tion for all these different

colors and sizes of #ills( all of which were inert( and the sense of #lace%o aswhen a #hysician writes a #rescri#tion for a dru' that the #hysician knows will nothave any effect on the #atient)s condition. It seems to me that the =uestion of theoveruse of anti%iotics can fall into this cate'ory. ! #atient #resents with a viralinfection( and the #hysician 'ives them anti%iotics. !ll of their medical trainin'tells them this is ina##ro#riate and won)t hel# the viral infection( %ut( they think( itwon)t hurt and it will make the #atient feel %etter.


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Dr. Berkowitz:

!nd I think this case would actually fit the outline of what Tim su''ested a#hysician run throu'h %efore 'ivin' a #lace%o. In this case I think the #atient)sdia'nosis is #retty firmshe wanted hel# to sto# smokin'. There)s no sense that

it was %ein' used as a dia'nostic tool( they were ineli'i%le for other thera#ies(and there was no #ro%lem with dece#tion %ecause it didn)t entail denyin' the#atient other thera#ies( and there was valid informed consent. In this situation( Idon)t have a #ro%lem with it.

Brian:

That was our thinkin' too( and I only %rou'ht that forward %ecause of all thecomments that we should totally a%olish this #ractice.

Ellen o/" D" National Center for Ethics in +ealth Care:

I remem%er va'uely readin' an article 1: years a'o testin' the use of #lace%owith informed consent. The #atient was told that they were 'oin' to %e 'iven asu'ar #ill( and that the su'ar #ill had no s#ecific effect on their sym#toms( %utH of #atient)s sym#toms res#onded anyway( and that this was a known#sycholo'ical effect.


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Eric Un0esser" %ackson &AC5

I)ve 'ot another s#in for you. ! #atient #resents with a dia'nostic dilemma ofseizures versus #suedo;seizures. The #atient is taken to the monitorin' unittheconvulsions are ta#ered and nothin')s ha##enin'( and they in@ect saline with

instructions to the #atient that this may #reci#itate a seizure to test whether theseizures are real.

Dr. Berkowitz5

This is clearly tryin' to use #lace%o as a dia'nostic tool( which I don)t think wecan su##ort.

Dr. o/:

In situations where there is some sort of #sycholo'ical #ro%lem that inhi%its

function( I was trained to use ritualized treatments. In other words( you tell the#atient( 4I)m 'oin' to do this( and do that( and that should make you feel %etter.7!nd I)ve seen this work more than once where the #atient is 4miraculously7cured. The #atient isn)t thou'ht to %e fakin'( %ut somehow throu'h this ritual(there is a #ositive effect.

Dr. Berkowitz5

!nd the same could %e said for #atients with #suedo;seizures( %ecause we can)tsay with certainty that those are volitional.

Peter +a!ser" D" Portlan0 &AC5

!re you #lannin' to have a discussion on #lace%o use in research?

Dr. Berkowitz5

I think that)s a 'ood to#ic for a future teleconference. In #uttin' this call to'ether(we realized that #uttin' %oth clinical and research use of #lace%o in one callwould %e @ust too much.

RO T+E IE,D

"ow I want to turn to our 4>rom the >ield7 se'ment( where we take commentsfrom our listeners on ethics to#ics not related to today)s call. 6lease remem%er(no s#ecific consultation re=uests in this o#en format( %ut I invite you now to makeyour comments on other ethics;related to#ics( or to continue our discussion onthe clinical use of #lace%o

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CONC,USION

+ell( as usual( we did not e0#ect to conclude this discussion in the time allotted(and unfortunately we are out of time for today&s discussion.

+e will #ost on our +e% site a very detailed summary of each "ational EthicsTeleconference. So #lease visit our +e% site to review today&s discussion. +ewill %e sendin' a follow u# email for this call that will include the links to thea##ro#riate we% addresses for the call summary( the C8E credits( and thereferences referred to.

I would like to thank everyone who has worked hard on the develo#ment(#lannin'( and im#lementation of this call. It is never a trivial task and I a##reciateeveryone&s efforts( es#ecially( Bar%ara Chanko( "ichelle Cherry( and othermem%ers of the Ethics Center and EES staff who su##ort these calls.

NE1T CA,,5 6lease remem%er that there will %e no "ET call in !u'ust. Thene0t call in the series will %e on +ednesday Se#tem%er 2( 9 from15 to 5 Eastern Time. 6lease look to the we%site and to your utlookemail for details and announcements.

+e will %e sendin' out a follow;u# e;mail for this call with the e;mail

addresses and links that you can use to access the Ethics Center( thesummary of this call and the instructions for o%tainin' C8E credits( and thereferences that I mentioned.

6lease let us know if you or someone you know should %e receivin' the

announcements for these calls and didn&t.

6lease let us know if you have su''estions for to#ics for future calls.

!'ain( our e;mail address is5 vhaethicsMh=.med.va.'ov.

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mailto:[email protected]?subject=National%20Ethics%20Teleconferencemailto:[email protected]?subject=National%20Ethics%20Teleconference


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References:

!merican "urses !ssociation #olicy statement on the use of #lace%o in treatin' cancer #ain.

Bailar( *C. D1. The 6owerful 6lace%o and the +izard of N. New England Journal ofMedicine. H99D1( 1LH;1LH.

Beaucham#( Tom A O Childress( *ames >. D1. "ew $ork5 0ford -niversity 6ress.

Beecher K. D12::. The 6owerful 6lace%o. JAMA. 1:2( 1L;1LL.

Ber'mann *( Chassany ( Gandiol *(


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#rofessor of #sychiatry( -niversity of "orth Carolina( Cha#el ill. Thomas 8e'erian( 8

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NET Topic 20040728 Clinical Use of Placebos