Regulr Article DOI: 10.1159/000091772 Finncil Ties between DSM-IV Pnel Members nd the Phrmceuticl Industry Lis Cosgrove b Sheldon Krimsky Mnish Vijyrghvn Lis Schneider University of Msschusetts, Boston, Mss., nd b Tufts University, Medford, Mss., USA Key Words Conflicts of interest Ethics Finncil interests Psychophrmcologics Abstrct Bckground: Incresing ttention hs been given to the trnsprency of potentil conflicts of interest in clinicl medicine nd biomedicl sciences, prticulrly in journl publishing nd science dvisory pnels. The uthors exmined the degree nd type of finncil ties to the phrmceuticl industry of pnel members responsible for revisions of the Dignostic nd Sttisticl Mnul of Mentl Disorders (DSM). Methods: By using multimodl screening techniques the uthors investigted the finncil ties to the phrmceuticl industry of 170 pnel members who contributed to the dignostic criteri produced for the DSM-IV nd the DSM-IV-TR. Results: Of the 170 DSM pnel members 95 (56%) hd one or more finncil ssocitions with compnies in the phrmceuticl industry. One hundred percent of the members of the pnels on Mood Disorders nd Schizophreni nd Other Psychotic Disorders hd finncil ties to drug compnies. The leding ctegories of finncil interest held by pnel members were reserch funding (42%), consultn- cies (22%) nd spekers bureu (16%). Conclusions: Our inquiry into the reltionships between DSM pnel members nd the phrmceuticl industry demonstrtes tht there re strong finncil ties between the industry nd those who re responsible for developing nd modifying the dignostic criteri for mentl illness. The connections re especilly strong in those dignostic res where drugs re the first line of tretment for mentl disorders. Full disclosure by DSM pnel members of their finncil reltionships with for-profit entities tht mnufcture drugs used in the tretment of mentl illness is recommended. Copyright 2006 S. Krger AG, Bsel Medicl journls begn introducing conflict-of-interest (COI) disclosure requirements for uthors two decdes go beginning with rticles of originl reserch. A growing wreness of the importnce of uthor disclosure in biomedicl publictions is reflected in the rising number of medicl journls tht hve dopted COI policies over the pst decde nd the support for such policies mong professionl societies. If finncil COI mong medicl reserchers cn bis the outcome of study (s recent reserch shows) [1, 2], there is s much reson to Fx +41 61 306 12 34 E-Mil krger@krger.ch www.krger.com 2006 S. Krger AG, Bsel 0033 3190/06/0753 0154$23.50/0 Accessible online t: www.krger.com/pps Sheldon Krimsky, PhD Deprtment of Urbn nd Environmentl Policy nd Plnning 97 Tlbot Ave Medford, MA 02155 (USA) Tel. +1 617 627 3394, Fx +1 617 627 3377, E-Mil sheldon.krimsky@tufts.edu
believe it cn lso bis the recommendtions mde by members of dvisory pnels [3 5]. The importnce of protecting the integrity nd public trust in scientific nd medicl dvisory committees hs been widely discussed [6, 7]. Yet, there remin res tht lck the trnsprency of finncil COIs tht hve become stndrd procedures in mny medicl publictions [8, 9]. To dte there hs been no study exmining the reltionship between the phrmceuticl industry nd the scientists comprising the dvisory pnels tht recommended chnges in the Dignostic nd Sttisticl Mnul of Mentl Disorders ( DSM ), leding medicl mnul used for the dignosis of psychitric disorders. Phrmceuticl compnies provide substntil funding for conventions, journls, nd reserch relted to wht is included in the DSM, becuse wht is considered dignosble directly impcts the sle of their drugs [10]. This unesy llince [11] ws evidenced when prominent journl reported tht it ws difficult to find reserch psychitrists to write n editoril bout the tretment of depression who did not hve finncil ties to the phrmceuticl compnies tht mnufcture ntidepressnt medictions [12]. Recently some members of the Americn Psychitric Assocition (APA) hve expressed concern bout the potentil for COI tht rises with the increse in industry support [13]. For exmple, t the nnul meeting of the APA in 2004 there were 54 industry-supported symposi. Also, phrmceuticl dvertising revenue in APA journls, totling USD 7.5 million in 2003, incresed 22% in 1 yer [14]. Objectives of the Study Continuously produced since 1952 by the APA, the DSM, currently in its sixth revision [15], is the officil mnul for psychitric dignosis in the United Sttes. 1 Its clssifiction system is used by government gencies nd for ll mentl helth professionls who seek third prty reimbursements. The mnul provides the stndrd psychitric txonomy found in psychitry nd psychology textbooks [16]. Nerly 400,000 mentl helth professionls, including psychitric nurses, socil workers, psychologists nd psychitrists prctice in the United 1 Outside of the United Sttes the officil coding system for mentl illness is the Interntionl Sttisticl Clssifiction of Diseses nd Relted Helth Problems, 10th Revision (ICD-10). According to the DSM IV-TR, the preprtion of DSM-IV hs been closely coordinted with the preprtion of Chpter V Mentl nd Behviourl Disorders of ICD-10. Sttes, most of whom hve tken instruction on the DSM [17]. In this study we investigted the finncil reltionships tht members of the dvisory bords to the DSM-IV nd the DSM-IV-TR hve hd with the phrmceuticl industry, which mnufctures drugs used by clinicins for the tretment of mentl disorders. We ssessed the extent nd types of finncil reltionships for ech of the dignostic pnels. Methods The Dignostic nd Sttisticl Mnul for Mentl Disorders ( DSM ) is orgnized round working groups or pnels. Most of the pnels ddress specific ctegory such s Mood Disorders. The members of ech pnel hve significnt influence in determining whether new dignosis should be dded or n older dignosis revised for the next edition of the mnul. From the ltest edition of the DSM (DSM-IV) nd the edition with text revision (DSM-IV- TR), we identified 228 individuls ssocited with the development of the volume. After deleting clericl stff, we were left with 170 expert members who comprised totl of 18 distinct pnels. Ech pnel member ws put through series of screens to determine whether he or she hs hd ny finncil ssocitions with one or more phrmceuticl compnies whose business is potentilly ffected by decisions or recommendtions mde by the pnel. The screens involved trcking publictions of the pnel member for disclosures of potentil COIs (in journls tht hve disclosure policies), nd submitting the pnel member s nme into the news medi dtbse Lexis-Nexis nd Internet serch engines. We lso submitted pnel members nmes into dtbses of the US Ptent nd Trdemrk Office to screen for holdings of intellectul property in drug whose sles could be ffected by recommendtions of the DSM. For exmple, the FDA s pprovl of Srfem (fluoxetine hydrochloride) for the tretment of premenstrul dysphoric disorder ws contingent upon expert testimony tht concluded tht premenstrul dysphoric disorder ws distinct clinicl entity tht should be included s mentl disorder in the DSM [18]. Pnel members were screened for ny finncil ffilitions they hd with the drug industry between the yers 1989 (the DSM-IV ws published in 1994) through 2004. By using multiple screening techniques to gther published or Internet dt on finncil ffilitions, we were ble to void methodology tht relied solely on self-reporting (e.g., surveying pnel members). Finncil ssocitions of interest for this study include: honorri, equity holdings in drug compny; principl in strtup compny, member of scientific dvisory bord or spekers bureu of drug compny; expert witness for compny in litigtion; ptent or copyright holder; consultncy; gifts from drug compnies including trvel, grnts, contrcts, nd reserch mterils. We use the term finncil interest in describing the reltionship between pnel members nd the phrmceuticl industry rther thn the term conflict of interest (COI) becuse the ltter term implies n interprettion of the interest. Thus, we choose not to define COI. Rther, we identify ctegories of finncil interest nd reserve judgment on whether they represent rel, perceived, or potentil COI. Finncil Ties between DSM-IV Pnel Members nd Phrmceuticl Industry 155
Our pproch is congruent with other publictions tht mke distinction between the finding of finncil interests nd the judgment of conflicts of interest [19 21]. Specificlly, there is less disgreement bout wht constitutes finncil interest thn there is bout wht mkes conflict of interest. The specific screening methods we pplied included Lexis-Nexis, Internet serch engines (such s Google nd Yhoo), the US Ptent nd Trdemrk Office Internet Site on ptents pending or wrded, nd Medline. Ech finding of pnel member s finncil connection to drug compny ws coded: H = honorrium; RF = reserch funding; RM = reserch mterils (equipment, drugs, cell cultures, etc); EQ = equity in compny; CB = member of corporte bord (dvisory bord or bord of directors); SB = spekers bureu; CON = consultnt; ET = expert testimony; DINP = drug industry nonprofit ( nonprofit orgniztion funded primrily by the phrmceuticl industry such s the Novrtis Foundtion); P = holds ptent, ptent ppliction or roylties on product relevnt to the tretment of mentl disorders, nd CIFS = collbortor in industry-funded study. Individuls clssified under CIFS re DSM pnel members who prticipted in study s coinvestigtor or collbortor, where the principl investigtor (rther thn the pnel member) ws described s funded by the phrmceuticl compny. A DSM pnel member who received fee from drug compny for speking t session of symposium sponsored by phrmceuticl compny ws coded s n H (received n honorrium). However, when university or medicl school receives unrestricted eductionl grnts from drug compny, the compny usully does not hve role in selecting the spekers, setting the honorri, or signing the speker s honorri check. For our study, pnel member who spoke t symposium but did not receive direct pyment from drug compny (e.g., he/she spoke t professionl meeting or Grnd Rounds of medicl school sponsored wholly or in prt by phrmceuticl compny) ws not coded s H. In other words, lecture honorri pid by university were considered s nondisclosble finncil interests for the purpose of this study. Although not included in our nlysis, we found 23 pnel members who gve tlks sponsored, in prt, by drug compnies but who were compensted by universities under unrestricted grnts. While our methodology llowed us to scertin vried finncil reltionships tht existed between DSM pnel members nd the phrmceuticl industry during the period of nlysis, it did not llow us to mke cusl inferences bout those reltionships. We could not determine whether, or to wht extent, n individul s ssocition with the phrmceuticl industry influenced his/her behvior on DSM pnel or, conversely, whether prticiption on DSM pnel influenced his/her subsequent involvement with the phrmceuticl industry. For the most prt, the dt on pnel member ssocitions with the phrmceuticl industry re temporl. Some of the finncil reltionships might hve occurred before, during, or fter publiction of the DSM volumes. Ethicl considertions re relevnt whether the pnel member s involvement in the drug industry occurred prior to or fter DSM publiction. Three investigtors independently conducted screens on the pnel members. Any questions bout coding were resolved by fourth investigtor. No pnel member ws coded s hving finncil connection unless there ws unmbiguous informtion confirming the reltionship. Interrter Relibility We chose 20% of the pnel members (every fifth nme) for n interrter relibility test. One investigtor, who ws not involved in coding, reviewed the dt for 19 nmes representing 44 coding decisions. This investigtor missed 2 coding decisions; ll other coding decisions mtched the results of the coding tem. Our test demonstrted tht the most likely error of using nother coder ws missing finncil interest. This error ws minimized by hving three independent coders who compred findings nd reched consensus. Our methodology tends to err in understting rther thn overstting the finncil interests of pnel members. Results Of the 170 DSM pnel members 95 (56%) hd one or more of the eleven finncil links to compny in the phrmceuticl industry. Figure 1 shows the percentges of the pnel members listed in the DSM-IV nd DSM- IV-TR with finncil linkges to drug compnies. Unless otherwise noted, the percentges given for ech DSM ctegory include the members from both the 1994 nd 2000 editions. In 6 out of 18 pnels more thn 80% of pnel members were found to hve finncil ties to the phrmceuticl industry. These include 100% of the pnels for the Mood Disorders Work Group (n = 8) nd the Schizophreni nd Other Psychotic Disorders Work Group (n = 7), 81% for Anxiety Disorders (n = 16), 83% for Eting Disorders (n = 6), 88% for Mediction-Induced Movement Disorders (n = 8) nd 83% for Premenstrul Dysphoric Disorders (n = 6) (see fig. 1 ). The mentl illness ctegories denoted by Mood Disorders nd Schizophreni nd Other Psychotic Disorders re the two min ctegories for which psychophrmcologicl tretment is stndrd prctice, wheres it is fr less likely for individuls dignosed with Substnce-Relted Disorders (17%; n = 6) to receive such tretment (unless there is coexisting mentl disorder such s mood disorder). The most frequent finncil link we found between the DSM expert pnels nd the drug industry is reserch funding. Among the 170 pnel members, 42% received reserch funding from phrmceuticl compnies; 22% were consultnts nd 16% served s members of drug compny s spekers bureu (see fig. 2 ). Of those pnel members who hd finncil links with the phrmceuticl industry (n = 95) 76% hd reserch funding, 40% hd consulting income, 29% served on spekers bureu, nd 25% received honorri other thn from serving on spekers bureu (see fig. 3 ). More thn hlf of the pnel members with finncil ties were found 156 Cosgrove /Krimsky /Vijyrghvn / Schneider
100.0 100.0 100.0 90.0 80.0 81.3 83.3 87.5 83.3 COI hits (%) 70.0 60.0 40.0 56.7 61.9 55.6 40.0 41.4 30.0 25.0 28.6 20.0 16.7 10.0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 DSM Committee Groups 0 Fig. 1. Percentge of pnel members of the DSM with finncil ties. 1 Tsk Force-IV 56.7 2 Anxiety Disorders 81.3 3 Delirium, Dementi, Amnestic nd Other Cognitive Disorders 25.0 4 Disorders Usully First Dignosed during Infncy, Childhood nd Adolescence 61.9 5 Eting Disorders 83.3 6 Mediction-Induced Movement Disorders (TR) 87.5 7 Mood Disorders 100.0 8 Multixil Issues 28.6 9 Personlity Disorders 55.6 % 10 Premenstrul Dysphoric Disorder 83.3 11 Psychitric Systems Interfce Disorders 12 Schizophreni nd Other Psychotic Disorders 100.0 13 Sexul Disorders (IV) 40.0 14 Sexul nd Gender Identity Disorders (TR) 15 Sleep Disorders 16 Substnce-Relted Disorders 16.7 17 Committee on Psychitric Dignosis nd Assessment 41.4 18 Joint Committee of the Bord of Trustees nd Assembly of District Brnches on Issues to DSM-IV 0.0 % to hve more thn one ctegory of finncil interests with the phrmceuticl industry. Eleven pnel members hd five different finncil ties (see fig. 4 ). When there were competing coding ctegories, only the most precise descriptor ws coded. For exmple, pnel member listed on spekers bureu, where he/she received honorri, ws coded only s SB. Hence, the percentges in figure 4 represent the most conservtive estimte of DSM pnel members with multiple finncil ssocitions to the phrmceuticl industry. Limittions The results of this study need to be interpreted in light of severl limittions. First, it is resonble to expect tht some types of finncil reltionships were not detected by our screening methods. For exmple, expert witnesses serving in litigtion re difficult to detect with stndrd screening tools. Second, our screening methods fell short of llowing us to quntify or to set temporl sequence for the ssocition. In most instnces informtion bout the mount of money received from phrmceuticl com- Finncil Ties between DSM-IV Pnel Members nd Phrmceuticl Industry 157
ET P EQ 0.59 1.76 2.35 RM 8.24 Fig. 2. Ctegories of finncil interest held by DSM Pnel Members: totl members (n = 170). RF = Reserch funding; CON = consultnt; SB = spekers bureu; CB = member of corporte bord; H = honorrium; CIFS = collbortor in industryfunded study; DINP = drug industry nonprofit ffilition; RM = reserch mterils; EQ = equity in compny; P = ptent; ET = expert testimony. COI ctegories DINP 10.00 CIFS 5.88 H 14.12 CB 13.53 SB 16.47 CON 22.35 RF 42.35 0 5 10 15 20 25 30 35 40 45 COI hits (n = 170) (%) ET P EQ 1.05 3.16 4.21 RM 14.74 Fig. 3. Ctegories of finncil interest held by DSM Pnel Members: members with finncil interests (n = 95). RF = Reserch funding; CON = consultnt; SB = spekers bureu; CB = member of corporte bord; H = honorrium; CIFS = collbortor in industry-funded study; DINP = drug industry nonprofit ffilition; RM = reserch mterils; EQ = equity in compny; P = ptent; ET = expert testimony. COI ctegories DINP 17.89 CIFS 10.53 H 25.26 CB 24.21 SB 29.47 CON 40.00 RF 75.79 0 10 20 30 40 50 60 70 80 COI hits (n = 95) (%) Fig. 4. DSM pnel members with multiple finncil interests. Number of pnel members 50 45 40 35 30 25 20 15 10 5 0 44 15 10 11 8 6 1 1 2 3 4 5 6 7 Pnel members with multiple finncil interest 158 Cosgrove /Krimsky /Vijyrghvn / Schneider
pnies ws not disclosed. Also, disclosures were reported strictly in terms of whether person ws current or pst recipient of industry support. Even mong journls tht hve set high stndrds on uthor disclosure, no specific dtes re given. For exmple, the following is typicl disclosure sttement: Dr. X hs received honorri nd reserch support from Compny Y nd Compny Z nd he lso serves on their spekers bureu. Becuse it ws not possible to quntify these reltionships or locte the precise time they occurred, only qulittive conclusions cn be drwn bout the extent of the finncil reltionships of DSM pnel members with the phrmceuticl industry. Also, no conclusions cn be drwn bout the impct these reltionships my hve hd on pnel member s behvior. However, there re ethicl concerns in these reltionships regrdless of the mount of money given or the timing of the finncil ssocition. A finncil reltionship held during (or just before) prticiption s n expert pnel member might influence or be perceived to influence the outcome of DSM work group. On the other hnd, if their ssocition with the phrmceuticl industry occurred fter work on the pnel ws completed, pnel members might be perceived s using their prestige to leverge lucrtive consulting rrngements with the phrmceuticl industry. In the ltter cse public trust in the independence of medicl science is eroded when former pnel members, who re vlued s thought leders [22], exert their influence on prescription prctices through consulting, public speking, nd prticiption in industrysponsored eductionl workshops. Finlly, we relied on self-reported disclosure dt tht ws vilble in the open literture. Author noncomplince with journl COI policies hs been cited s problem [23]. Therefore, the percentges of DSM pnel members identified s hving finncil ties nd the vriety of their ties to the phrmceuticl industry should be considered de minimis figures. Comments Receiving finncil support from phrmceuticl compny should not utomticlly disqulify n individul from serving on DSM pnel. However, the public nd mentl helth professionls hve right to know bout these finncil ties, becuse phrmceuticl compnies hve vested interest in wht mentl disorders re included in the DSM. Trnsprency is especilly importnt when there re multiple nd continuous finncil reltionships between pnel members nd the phrmceuticl industry, becuse of the greter likelihood tht the drug industry my be exerting n undue influence on the DSM. As previously noted, the DSM working groups tht hd the highest percentge of finncil ties to the phrmceuticl industry were those groups working in dignostic res (e.g., mood disorders nd psychotic disorders) where phrmcologicl interventions re stndrd tretment. In light of the extreme profitbility of the psychotropic drug mrket, the connections found in this study between the DSM nd the phrmceuticl industry re cuse for concern. For exmple, ntidepressnts nd ntipsychotics were the fourth nd fifth leding therpy clsses of drugs in 2004, with nnul globl sles totling USD 20.3 nd USD 14.1 billion dollrs, respectively [24]. One ntidepressnt lone, venlfxine (Effexor, Wyeth) chieved USD 3.7 billion in sles in 2004 [25]. The ntipsychotic drug mrket hs been identified s one of min therpeutic res for globl mrket growth with sles of USD 8.5 billion in 2002 nd projected sles of USD 18.2 billion by 2007 [26]. Therefore, we recommend tht the APA institute disclosure policy for pnel members of the DSM who hve finncil ties to the drug industry. This is consistent with the trend for greter trnsprency in the membership of federl dvisory pnels. Rising wreness bout the rel or perceived COI of pnel members is n importnt public helth issue [27 32]. Trnsprency should lso pply to journl publiction [33, 34]. We undertook serch of Ulrich s Periodicls Directory using the terms psychitry nd drugs, psychophrmcology, drugs nd mentl illness nd psychitry nd mediction. When restricted to the descriptors ctive, cdemic/scholrly, English lnguge nd refereed journls, the serch identified 45 journls of psychitry. Of those, 19 hd COI disclosure policies (42%). Mny of the finncil ties tht were found in this study were discovered becuse of these disclosure policies. Thus, we lso recommend tht ll psychitry journls dopt COI policies following the recommendtions of the Interntionl Committee of Medicl Journl Editors. Acknowledgments We re most grteful for the ssistnce of two UMss grdute students, Michelle Levinson nd Greg Nog nd one Tufts University undergrdute student Nomi Mower, ll of whom conducted preliminry serches. Ms. Mower prticipted through summer scholrs grnt from Tufts University provided through the university s endowment. Dr. Krimsky ws her mentor under the progrm. He received smll stipend for supplies. No other prticipnts of the study were supported by grnts. Finncil Ties between DSM-IV Pnel Members nd Phrmceuticl Industry 159
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