Financial Ties between DSM-IV Panel Members and the Pharmaceutical ...

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Psychother Psychosom 2006;75:154–160

DOI: 10.1159/000091772

Financial Ties between DSM-IV Panel
Members and the Pharmaceutical

Lisa Cosgrove a Sheldon Krimsky b Manisha Vijayaraghavan a

Lisa Schneider a

a University of Massachusetts, Boston, Mass. , and b Tufts University, Medford, Mass. , USA

Key Words
cies (22%) and speakers bureau (16%). Conclusions: Our

Confl icts of interest Ethics Financial interests
inquiry into the relationships between DSM panel mem-
bers and the pharmaceutical industry demonstrates that
there are strong fi nancial ties between the industry and
those who are responsible for developing and modifying

the diagnostic criteria for mental illness. The connec-

Background: Increasing attention has been given to the
tions are especially strong in those diagnostic areas
transparency of potential confl icts of interest in clinical
where drugs are the fi rst line of treatment for mental dis-
medicine and biomedical sciences, particularly in journal
orders. Full disclosure by DSM panel members of their
publishing and science advisory panels. The authors ex-
fi nancial relationships with for-profi t entities that manu-
amined the degree and type of fi nancial ties to the phar-
facture drugs used in the treatment of mental illness is
maceutical industry of panel members responsible for
revisions of the Diagnostic and Statistical Manual of

Copyright © 2006 S. Karger AG, Basel
Mental Disorders (DSM) . Methods: By using multimodal
screening techniques the authors investigated the fi nan-
cial ties to the pharmaceutical industry of 170 panel

Medical journals began introducing confl ict-of-inter-
members who contributed to the diagnostic criteria pro-
est (COI) disclosure requirements for authors two de-
duced for the DSM-IV and the DSM-IV-TR. Results: Of the
cades ago beginning with articles of original research. A
170 DSM panel members 95 (56%) had one or more fi -
growing awareness of the importance of author disclosure
nancial associations with companies in the pharmaceuti-
in biomedical publications is refl ected in the rising num-
cal industry. One hundred percent of the members of the
ber of medical journals that have adopted COI policies
panels on ‘Mood Disorders’ and ‘Schizophrenia and Oth-
over the past decade and the support for such policies
er Psychotic Disorders’ had fi nancial ties to drug compa-
among professional societies. If fi nancial COI among
nies. The leading categories of fi nancial interest held by
medical researchers can bias the outcome of a study (as
panel members were research funding (42%), consultan-
recent research shows) [1, 2] , there is as much reason to

© 2006 S. Karger AG, Basel

Sheldon Krimsky, PhD
Department of Urban and Environmental Policy and Planning
Fax +41 61 306 12 34
97 Talbot Ave
E-Mail [email protected]

Accessible online at:
Medford, MA 02155 (USA)
Tel. +1 617 627 3394, Fax +1 617 627 3377, E-Mail [email protected]

believe it can also bias the recommendations made by States, most of whom have taken instruction on the DSM
members of advisory panels [3–5] . The importance of [17] .
protecting the integrity and public trust in scientifi c and

In this study we investigated the fi nancial relationships
medical advisory committees has been widely discussed
that members of the advisory boards to the DSM-IV and

[6, 7] . Yet, there remain areas that lack the transparency
the DSM-IV-TR have had with the pharmaceutical in-
of fi nancial COIs that have become standard procedures
dustry, which manufactures drugs used by clinicians for
in many medical publications [8, 9] .
the treatment of mental disorders. We assessed the extent

To date there has been no study examining the rela-
and types of fi nancial relationships for each of the diag-
tionship between the pharmaceutical industry and the nostic panels.
scientists comprising the advisory panels that recom-
mended changes in the Diagnostic and Statistical Manu-
al of Mental Disorders
( DSM ) , a leading medical manual

used for the diagnosis of psychiatric disorders. Pharma-

The Diagnostic and Statistical Manual for Mental Disorders
ceutical companies provide substantial funding for con-
( DSM ) is organized around working groups or panels. Most of the
ventions, journals, and research related to what is includ-
panels address a specifi c category such as ‘Mood Disorders’. The
ed in the DSM, because what is considered diagnosable
members of each panel have signifi cant infl uence in determining
directly impacts the sale of their drugs [10] . This ‘uneasy
whether a new diagnosis should be added or an older diagnosis re-
vised for the next edition of the manual. From the latest edition of
alliance’ [11] was evidenced when a prominent journal the DSM (DSM-IV) and the edition with text revision (DSM-IV-
reported that it was diffi cult to fi nd research psychiatrists
TR), we identifi ed 228 individuals associated with the development
to write an editorial about the treatment of depression of the volume. After deleting clerical staff, we were left with 170
who did not have fi nancial ties to the pharmaceutical expert members who comprised a total of 18 distinct panels.
companies that manufacture antidepressant medications

Each panel member was put through a series of ‘screens’ to de-
termine whether he or she has had any fi nancial associations with

[12] . Recently some members of the American Psychiat-
one or more pharmaceutical companies whose business is poten-
ric Association (APA) have expressed concern about the
tially affected by decisions or recommendations made by the pan-
potential for COI that arises with the increase in industry
el. The ‘screens’ involved tracking publications of the panel mem-
support [13] . For example, at the annual meeting of the
ber for disclosures of potential COIs (in journals that have disclo-
APA in 2004 there were 54 industry-supported symposia.
sure policies), and submitting the panel member’s name into the
news media database Lexis-Nexis and Internet search engines. We
Also, pharmaceutical advertising revenue in APA jour-
also submitted panel members’ names into databases of the US
nals, totaling USD 7.5 million in 2003, increased 22% in
Patent and Trademark Offi ce to screen for holdings of intellectual
1 year [14] .
property in a drug whose sales could be affected by recommenda-
tions of the DSM. For example, the FDA’s approval of Sarafem
(fl uoxetine hydrochloride) for the treatment of premenstrual dys-
phoric disorder was contingent upon expert testimony that con-

Objectives of the Study
cluded that premenstrual dysphoric disorder was a distinct clinical
entity that should be included as a mental disorder in the DSM

Continuously produced since 1952 by the APA, the [18] .
DSM, currently in its sixth revision [15] , is the offi cial

Panel members were screened for any fi nancial affi liations they
manual for psychiatric diagnosis in the United States.1
had with the drug industry between the years 1989 (the DSM-IV
was published in 1994) through 2004. By using multiple screening
Its classifi cation system is used by government agencies
techniques to gather published or Internet data on fi nancial affi lia-
and for all mental health professionals who seek third tions, we were able to avoid a methodology that relied solely on
party reimbursements. The manual provides the stan-
self-reporting (e.g., surveying panel members).
dard psychiatric taxonomy found in psychiatry and psy-

Financial associations of interest for this study include: hono-
chology textbooks [16] . Nearly 400,000 mental health raria, equity holdings in a drug company; principal in a startup
company, member of a scientifi c advisory board or speakers bureau
professionals, including psychiatric nurses, social work-
of a drug company; expert witness for a company in litigation; pat-
ers, psychologists and psychiatrists practice in the United
ent or copyright holder; consultancy; gifts from drug companies
including travel, grants, contracts, and research materials. We use
the term ‘fi nancial interest’ in describing the relationship between
panel members and the pharmaceutical industry rather than the
1 Outside of the United States the offi cial coding system for mental illness
term ‘confl ict of interest’ (COI) because the latter term implies an
is the International Statistical Classifi cation of Diseases and Related Health
interpretation of the interest. Thus, we choose not to defi ne COI.
Problems, 10th Revision (ICD-10). According to the DSM IV-TR, the prepara-
tion of DSM-IV has been closely coordinated with the preparation of Chapter
Rather, we identify categories of fi nancial interest and reserve judg-
V ‘Mental and Behavioural Disorders’ of ICD-10.
ment on whether they represent a real, perceived, or potential COI.

Financial Ties between DSM-IV Panel

Psychother Psychosom 2006;75:154–160
Members and Pharmaceutical Industry

Our approach is congruent with other publications that make a

Interrater Reliability

distinction between the fi nding of ‘fi nancial interests’ and the judg-

We chose 20% of the panel members (every fi fth name) for an
ment of ‘confl icts of interest’ [19–21] . Specifi cally, there is less dis-
interrater reliability test. One investigator, who was not involved
agreement about what constitutes a ‘fi nancial interest’ than there
in coding, reviewed the data for 19 names representing 44 coding
is about what makes a ‘confl ict of interest’.
decisions. This investigator missed 2 coding decisions; all other

The specifi c screening methods we applied included Lexis-Nex-
coding decisions matched the results of the coding team. Our test
is, Internet search engines (such as Google and Yahoo), the US Pat-
demonstrated that the most likely error of using another coder was
ent and Trademark Offi ce Internet Site on patents pending or
missing a fi nancial interest. This error was minimized by having
awarded, and Medline. Each fi nding of a panel member’s fi nancial
three independent coders who compared fi ndings and reached con-
connection to a drug company was coded: H = honorarium; RF =
sensus. Our methodology tends to err in understating rather than
research funding; RM = research materials (equipment, drugs, cell
overstating the fi nancial interests of panel members.
cultures, etc); EQ = equity in a company; CB = member of a cor-
porate board (advisory board or board of directors); SB = speakers
bureau; CON = consultant; ET = expert testimony; DINP = drug
industry nonprofi t (a nonprofi t organization funded primarily by

the pharmaceutical industry such as the Novartis Foundation);
P = holds a patent, patent application or royalties on a product rel-
evant to the treatment of mental disorders, and CIFS = collaborator

Of the 170 DSM panel members 95 (56%) had one or
in industry-funded study. Individuals classifi ed under CIFS are
more of the eleven fi nancial links to a company in the
DSM panel members who participated in a study as a coinvestiga-
pharmaceutical industry. Figure 1 shows the percentages
tor or collaborator, where the principal investigator (rather than the
of the panel members listed in the DSM-IV and DSM-
panel member) was described as funded by the pharmaceutical
IV-TR with fi nancial linkages to drug companies. Unless

A DSM panel member who received a fee from a drug company
otherwise noted, the percentages given for each DSM cat-
for speaking at a session of a symposium sponsored by a pharma-
egory include the members from both the 1994 and 2000
ceutical company was coded as an H (received an honorarium).
editions. In 6 out of 18 panels more than 80% of panel
However, when a university or medical school receives unrestrict-
members were found to have fi nancial ties to the phar-
ed educational grants from a drug company, the company usually
does not have a role in selecting the speakers, setting the honoraria,
maceutical industry. These include 100% of the panels
or signing the speaker’s honoraria check. For our study, a panel
for the ‘Mood Disorders Work Group’ (n = 8) and the
member who spoke at a symposium but did not receive direct pay-
‘Schizophrenia and Other Psychotic Disorders Work
ment from a drug company (e.g., he/she spoke at a professional
Group’ (n = 7), 81% for ‘Anxiety Disorders’ (n = 16), 83%
meeting or Grand Rounds of a medical school sponsored wholly or
for ‘Eating Disorders’ (n = 6), 88% for ‘Medication-In-
in part by a pharmaceutical company) was not coded as H. In oth-
er words, lecture honoraria paid by a university were considered as
duced Movement Disorders’ (n = 8) and 83% for ‘Pre-
nondisclosable fi nancial interests for the purpose of this study. Al-
menstrual Dysphoric Disorders’ (n = 6) (see fi g. 1 ). The
though not included in our analysis, we found 23 panel members
mental illness categories denoted by ‘Mood Disorders’
who gave talks sponsored, in part, by drug companies but who were
and ‘Schizophrenia and Other Psychotic Disorders’ are
compensated by universities under unrestricted grants.
the two main categories for which psychopharmacologi-

While our methodology allowed us to ascertain varied fi nancial
relationships that existed between DSM panel members and the
cal treatment is standard practice, whereas it is far less
pharmaceutical industry during the period of analysis, it did not
likely for individuals diagnosed with ‘Substance-Related
allow us to make causal inferences about those relationships. We
Disorders’ (17%; n = 6) to receive such treatment (unless
could not determine whether, or to what extent, an individual’s as-
there is a coexisting mental disorder such as a mood dis-
sociation with the pharmaceutical industry infl uenced his/her be-
havior on a DSM panel or, conversely, whether participation on a
DSM panel infl uenced his/her subsequent involvement with the

The most frequent fi nancial link we found between the
pharmaceutical industry. For the most part, the data on panel mem-
DSM expert panels and the drug industry is ‘research
ber associations with the pharmaceutical industry are atemporal.
funding’. Among the 170 panel members, 42% received
Some of the fi nancial relationships might have occurred before,
research funding from pharmaceutical companies; 22%
during, or after publication of the DSM volumes. Ethical consider-
were consultants and 16% served as members of a drug
ations are relevant whether the panel member’s involvement in the
drug industry occurred prior to or after DSM publication.
company’s speakers bureau (see fi g. 2 ).

Three investigators independently conducted screens on the

Of those panel members who had fi nancial links with
panel members. Any questions about coding were resolved by a
the pharmaceutical industry (n = 95) 76% had research
fourth investigator. No panel member was coded as having a fi nan-
funding, 40% had consulting income, 29% served on a
cial connection unless there was unambiguous information con-
speakers bureau, and 25% received honoraria other than
fi rming the relationship.
from serving on a speakers bureau (see fi g. 3 ). More than
half of the panel members with fi nancial ties were found

Psychother Psychosom 2006;75:154–160



COI hits (%)
DSM Committee Groups

Fig. 1. Percentage of panel members of the DSM with fi nancial ties.
Task Force-IV
Premenstrual Dysphoric Disorder
Anxiety Disorders
Psychiatric Systems Interface Disorders
Delirium, Dementia, Amnestic and Other Cognitive
Schizophrenia and Other Psychotic Disorders
Sexual Disorders (IV)
Disorders Usually First Diagnosed during Infancy,
Sexual and Gender Identity Disorders (TR)
Childhood and Adolescence
Sleep Disorders
Eating Disorders
Substance-Related Disorders
Medication-Induced Movement Disorders (TR)
Committee on Psychiatric Diagnosis and Assessment
Mood Disorders
Joint Committee of the Board of Trustees and
Multiaxial Issues

Assembly of District Branches on Issues to DSM-IV
Personality Disorders
to have more than one category of fi nancial interests with

the pharmaceutical industry. Eleven panel members had
fi ve different fi nancial ties (see fi g. 4 ). When there were

The results of this study need to be interpreted in light
competing coding categories, only the most precise de-
of several limitations. First, it is reasonable to expect that
scriptor was coded. For example, a panel member listed
some types of fi nancial relationships were not detected by
on a speakers bureau, where he/she received honoraria,
our screening methods. For example, expert witnesses
was coded only as ‘SB’. Hence, the percentages in fi gure 4
serving in litigation are diffi cult to detect with standard
represent the most conservative estimate of DSM panel
screening tools. Second, our screening methods fell short
members with multiple fi nancial associations to the phar-
of allowing us to quantify or to set a temporal sequence
maceutical industry.
for the association. In most instances information about
the amount of money received from pharmaceutical com-

Financial Ties between DSM-IV Panel

Psychother Psychosom 2006;75:154–160
Members and Pharmaceutical Industry


Fig. 2. Categories of fi nancial interest held
by DSM Panel Members: total members
(n = 170). RF = Research funding; CON =
consultant; SB = speakers bureau; CB =
member of a corporate board; H = hono-
rarium; CIFS = collaborator in industry-
funded study; DINP = drug industry non-
profi t affi liation; RM = research materials;
EQ = equity in a company; P = patent;
COI hits (n = 170) (%)
ET = expert testimony.

Fig. 3. Categories of fi nancial interest held
by DSM Panel Members: members with fi -
nancial interests (n = 95). RF = Research
funding; CON = consultant; SB = speakers
bureau; CB = member of a corporate board;
H = honorarium; CIFS = collaborator in in-
dustry-funded study; DINP = drug industry
nonprofi t affi liation; RM = research materi-
COI hits (n = 95) (%)
als; EQ = equity in a company; P = patent;
ET = expert testimony.
members 30
panel 20
Panel members with multiple financial interest

Fig. 4. DSM panel members with multiple
fi nancial interests.

Psychother Psychosom 2006;75:154–160



panies was not disclosed. Also, disclosures were reported
ceutical industry, because of the greater likelihood that
strictly in terms of whether a person was a current or past
the drug industry may be exerting an undue infl uence on
recipient of industry support. Even among journals that
the DSM. As previously noted, the DSM working groups
have set high standards on author disclosure, no specifi c
that had the highest percentage of fi nancial ties to the
dates are given. For example, the following is a typical pharmaceutical industry were those groups working in
disclosure statement: ‘Dr. X has received honoraria and
diagnostic areas (e.g., mood disorders and psychotic dis-
research support from Company Y and Company Z and
orders) where pharmacological interventions are stan-
he also serves on their speakers bureau.’ Because it was
dard treatment. In light of the extreme profi tability of the
not possible to quantify these relationships or locate the
psychotropic drug market, the connections found in this
precise time they occurred, only qualitative conclusions
study between the DSM and the pharmaceutical industry
can be drawn about the extent of the fi nancial relation-
are cause for concern. For example, antidepressants and
ships of DSM panel members with the pharmaceutical antipsychotics were the fourth and fi fth leading therapy
industry. Also, no conclusions can be drawn about the classes of drugs in 2004, with annual global sales totaling
impact these relationships may have had on a panel mem-
USD 20.3 and USD 14.1 billion dollars, respectively [24] .
ber’s behavior. However, there are ethical concerns in One antidepressant alone, venlafaxine (Effexor, Wyeth)
these relationships regardless of the amount of money giv-
achieved USD 3.7 billion in sales in 2004 [25] . The anti-
en or the timing of the fi nancial association. A fi nancial
psychotic drug market has been identifi ed as one of main
relationship held during (or just before) participation as
therapeutic areas for global market growth with sales of
an expert panel member might infl uence or be perceived
USD 8.5 billion in 2002 and projected sales of USD 18.2
to infl uence the outcome of a DSM work group. On the
billion by 2007 [26] . Therefore, we recommend that the
other hand, if their association with the pharmaceutical
APA institute a disclosure policy for panel members of
industry occurred after work on the panel was completed,
the DSM who have fi nancial ties to the drug industry.
panel members might be perceived as using their prestige
This is consistent with the trend for greater transparency
to leverage lucrative consulting arrangements with the in the membership of federal advisory panels. Raising
pharmaceutical industry. In the latter case public trust in
awareness about the real or perceived COI of panel mem-
the independence of medical science is eroded when for-
bers is an important public health issue [27–32] .
mer panel members, who are valued as ‘thought leaders’

Transparency should also apply to journal publication

[22] , exert their infl uence on prescription practices through

[33, 34] . We undertook a search of Ulrich’s Periodicals
consulting, public speaking, and participation in industry-
Directory using the terms ‘psychiatry and drugs’, ‘psycho-
sponsored educational workshops.
pharmacology’, ‘drugs and mental illness’ and ‘psychiatry

Finally, we relied on self-reported disclosure data that
and medication’. When restricted to the descriptors ‘ac-
was available in the open literature. Author noncompli-
tive’, ‘academic/scholarly’, ‘English language’ and ‘refer-
ance with journal COI policies has been cited as a prob-
eed journals’, the search identifi ed 45 journals of psychi-
lem [23] . Therefore, the percentages of DSM panel mem-
atry. Of those, 19 had COI disclosure policies (42%).
bers identifi ed as having fi nancial ties and the variety of
Many of the fi nancial ties that were found in this study
their ties to the pharmaceutical industry should be con-
were discovered because of these disclosure policies.
sidered de minimis fi gures.
Thus, we also recommend that all psychiatry journals
adopt COI policies following the recommendations of the
International Committee of Medical Journal Editors.


Receiving fi nancial support from a pharmaceutical

company should not automatically disqualify an individ-
ual from serving on a DSM panel. However, the public

We are most grateful for the assistance of two UMass graduate
students, Michelle Levinson and Greg Noga and one Tufts Univer-
and mental health professionals have a right to know sity undergraduate student Naomi Mower, all of whom conducted
about these fi nancial ties, because pharmaceutical com-
preliminary searches. Ms. Mower participated through a summer
panies have a vested interest in what mental disorders are
scholars grant from Tufts University provided through the univer-
included in the DSM. Transparency is especially impor-
sity’s endowment. Dr. Krimsky was her mentor under the program.
tant when there are multiple and continuous fi nancial
He received a small stipend for supplies. No other participants of
the study were supported by grants.
relationships between panel members and the pharma-

Financial Ties between DSM-IV Panel

Psychother Psychosom 2006;75:154–160
Members and Pharmaceutical Industry

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Psychother Psychosom 2006;75:154–160