Innovations

Psychother Psychosom 2009;78:220–227 Received: June 6, 2008

Accepted after revision: August 25, 2008
DOI: 10.1159/000214443
Published online: April 28, 2009

The Decline of Pharmaceutical Psychiatry and the

Increasing Role of Psychological Medicine
Giovanni A. Fava
Affective Disorders Program, Department of Psychology, University of Bologna, Bologna, Italy;
Department of Psychiatry, State University of New York at Buffalo, Buffalo, N.Y., USA

Key Words Introduction

Pharmaceutical psychiatry ⴢ Psychological medicine ⴢ
Depressive disorder ⴢ Antidepressive agents ⴢ Conflict The issue of conflict of interest has brought clinical
of interest ⴢ Psychological well-being ⴢ Psychotherapy ⴢ medicine to an unprecedented crisis of credibility [1–3].
Psychosomatic medicine Corporate actions that have placed profit over public
health have become regular news in the media. The pub-
lic seems to be increasingly skeptical of the integrity of
Abstract medical practice. Psychiatry is affected by the contami-
The increasing influence of the pharmaceutical industry on nation of conflict of interest as much as other medical
psychiatric research and practice is leading to an intellectual specialties [4], but its hard to define borders [5] make it
and clinical crisis. A narrow concept of science attempts to more vulnerable to a loss of credibility and ideological
apply oversimplified neurobiological models to the under- attacks [6, 7]. These criticisms, however, do not entail re-
standing and treatment of mental disorders, and relegates lief to suffering and mental pain, whose importance for
psychiatrists to a marginal role. This paper reviews some public health is getting increasing attention [8]. The aim
emerging trends of renewal that may be subsumed under of this review is to discuss the impact of financial inter-
the rubric of psychological medicine: use of a multidisci- ests on psychiatric research and practice, the inadequa-
plinary approach, emphasis on psychotherapeutic strate- cies of current research and practice, and emerging trends
gies leading to self-management, reliance on repeated as- of renewal that may be subsumed under the rubric of psy-
sessments, integration of different treatment modalities and chological medicine. Depression will be used as an illus-
independence from the pharmaceutical industry. The con- tration of the issues under consideration. Reference to
cept of psychological medicine, defined as the clinical ap- pioneers of the concept of psychological medicine, who
plication of the psychosomatic approach, may provide room anticipated the current need of development in psychia-
for innovative paths in psychiatric research and treatment. try 2 or 3 decades ago, will be made.
Copyright © 2009 S. Karger AG, Basel

The Rise of Pharmaceutical Psychiatry

This paper is dedicated to the memory of George Molnar, MD (1931– The influence of the pharmaceutical industry on psy-
2009), whose outstanding clinical skills, research insights and moral chiatric research extends over several domains. The prev-
integrity have shaped my first exposure to the clinical process. alence of situations of conflict of interest has progres-
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© 2009 S. Karger AG, Basel G.A. Fava, MD

San Diego State University

0033–3190/09/0784–0220$26.00/0 Department of Psychology, University of Bologna

Fax +41 61 306 12 34 Viale Berti Pichat 5
E-Mail [email protected] Accessible online at: IT–40127 Bologna (Italy)
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www.karger.com www.karger.com/pps Tel. +39 051 209 1339, Fax +39 051 243 086, E-Mail [email protected]
sively increased. Cosgrove et al. [9] have addressed the was not, whereas only 3 of the 36 negative studies were
issue of the financial ties with the pharmaceutical indus- published [22]. Not surprisingly, when all the data of
try of the 170 panel members of the standard classifica- clinical trials submitted to the FDA for the licensing of 4
tion system in psychiatry, DSM-IV. Ninety-five (56%) had new-generation antidepressants were analyzed, there
1 or more associations with companies. The percentage were no significant differences between drugs and pla-
reached 100% among members of the panels on mood cebo except in the most severe cases [23].
disorders and schizophrenia, and was above 80% among Independent studies may yield misleading conclusions
members of the panels on anxiety and eating disorders. if they are associated with a certain type of press and inap-
Disclosure, despite journals’ policies, is seldom per- propriate labeling. For instance, in the early 80s Gibbons
formed (in less than 1% of published medical articles ac- and Davis [24] called attention to the fallacies of attempt-
cording to a study by Krimsky [10]). Failures to disclose ing correlations with longitudinal psychiatric data, which
financial interests led to the resignation of the leading may lead to relate ‘the price of beer and salaries of priests’.
author from the editorship of an important psychophar- Nonetheless, Gibbons et al. [25], more than 20 years later,
macology journal [11], but not from other important po- attempted to correlate decreased antidepressant drug use,
sitions. following the FDA black box warning regarding potential
In psychopharmacology, it has been repeatedly report- suicidal ideation in children and adolescents, and the in-
ed that studies sponsored by pharmaceutical companies creased suicide rate in US adolescents. Despite a caution-
were more likely to have outcomes favorable to the spon- ary editorial [26], critical letters [27–29], subsequent evi-
sor [12–15]. The marketing of drug treatments has re- dence suggesting that treatment is probably too sporadic
vealed its potential in the overselling of psychotropic to affect overall suicide rates [30–32], and that important
drug indications and the opportunistic ‘rediscovery’ of key factors such as unemployment might affect the rates
certain mental disorders [16]. As Carroll [17] had warned [32], a superficial reading of the original paper by Gibbons
in the early 80s, while anticipating the rise in antidepres- et al. [25] may generate the idea that careful prescription of
sant consumption [18]: ‘We strongly suspect that many antidepressant drugs in adolescence may damage that pa-
patients who are simply unhappy or dysphoric receive tient population. An example of the importance of labeling
these drugs, with predictable consequences in terms of may be provided by the use of the term ‘antidepressant dis-
morbidity from side effects, mortality from overdose, continuation syndrome’ for withdrawal syndromes, which
economic waste, and irrational, unproductive clinical frequently occur with antidepressant drug interruptions
management’ [17, p 169]. Based on the evidence that at- and may entail important clinical implications [33, 34].
tending sponsored continuing medical education events The labeling, which is free of negative associations and
and accepting funding for travel or lodging are associated minimizes the phenomena, may lead the physician to mis-
with an increased prescription rate of the sponsor’s med- interpret withdrawal reactions with signs of impending re-
ication [19], marketing has been aggressive, particularly lapse. Prompt response to the reinstitution of antidepres-
at meetings. In a study of all exhibit booths of pharma- sant treatment may reinforce this conviction.
ceutical companies at the 2002 American Psychiatric As- The rise of pharmaceutical psychiatry has found a most
sociation (APA) convention, a total of 16 violations of the favorable climate in the progress of neurosciences. Dur-
APA own exhibit rules was found [20]. Private companies ing the 1940s and 1950s, electrophysiology was regarded
have set campaigns to shape a favorable climate of opin- as the paradigmatic discipline in terms of which behav-
ion for their drugs. These campaigns take the form of ioral disorders would eventually be understood [17]. From
commercially strategic clinical trials (which have been the 60s to the 80s, psychopharmacology and psychoneuro-
defined by Carroll [21] as ‘experimercials’), journal pub- endocrinology renewed these hopes. The progress of neu-
lications that are ‘infomercials’ [21] and educational ac- rosciences in the past 2 decades has often led people to
tivities whose main aim is to sell the sponsor’s message to believe that clinical problems in psychiatry were likely to
the participant [4]. The game is clear: to get as close as be ultimately solved by this approach. Such hopes are un-
possible to universal consumption of a drug, by manipu- derstandable in terms of massive propaganda operated by
lating evidence and withholding data. Two recent papers biotechnology corporations [35, 36], and reaction to a long
provide a good illustration as to how selective publication prevalence of ‘brainless’ approaches [37].
of antidepressant trials promotes their apparent efficacy. An increasing number of psychiatrists are wondering,
Thirty-seven of the 74 FDA-registered studies that were however, why the cures and clinical insights that neuro-
associated with positive outcomes were published and 1 sciences have promised have not taken place. Biological
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reductionism [38] has resulted in an idealistic approach, models derived from basic domains such as neurobiology
which is quite far from the explanatory pluralism re- and economics: ‘All the fundamental scholarly ideas
quired by clinical practice. Kendler [38] has been an out- come from elsewhere, and clinicians apparently have
spoken critic of this reductionism, cautioning, for in- nothing important to contribute beyond their work in ap-
stance, on the impact of individual genes on the risk of plying the basic ideas’ [48, p 217].
psychiatric illness [39]. This intellectual crisis has been particularly detrimen-
tal in psychiatry. If ‘medical journals are an extension of
the marketing arm of pharmaceutical companies’ [2] and
The Decline and Inadequacies of Pharmaceutical corporate interests result in self-selecting academic oli-
Psychiatry garchies (special interest groups) that influence clinical
and scientific information [4], one may wonder how can
A large amount of clinical research is derivative: meth- a clinician discern important information (‘Is the treat-
ods are often applied in clinical studies simply because ment effective and to whom shall I give it?’ or ‘What harm
they have become available [17]. If the clinical problem may I do by using it?’) [49] from the massive amount of
itself is poorly defined and obfuscated by marketing strat- propaganda delivered by medical journals and meetings.
egies, the focus of neurobiological research is set for ran- Nierenberg et al. [50] have illustrated how systematic bi-
dom effort and misunderstanding. There has been a pro- ases in decision making induced by pharmaceutical com-
gressive detachment of psychiatric practice from research panies occur in clinical psychopharmacology. As Healy
[40]. The conceptual crisis of research in psychiatry stems [51] remarks: ‘Randomized placebo-controlled trials
from a narrow concept of science, which neglects clinical originated as efforts to debunk therapeutic claims, but
observation, the basic method of medicine [41, 42], and the force field in which medicine is now practiced has
simply attempts to apply oversimplified neurobiological transformed them into technologies that mandate ac-
models to the understanding and treatment of mental tion … Where the placebo arms of antidepressant, anti-
disorders. Enhancing the benefits of research where clin- psychotic or mood stabilizer trials suggest we should not
ical need is greatest, and not only where commercial op- be using the drugs as readily as we do, the trials of these
portunity is perceived, is a current priority of medicine products, embodied in guidelines, have instead become a
[43]. However, such priority could hardly be achieved in means to enforce treatment’ [51, p 200].
psychiatry unless a critical examination and update of Therapeutic outcomes are always the result of several
current paradigms is endorsed. ingredients, which may be specific or nonspecific [40, 52–
The fact that clinicians browsing a journal issue may 55]. Antidepressant drugs are therapeutic tools of modest
no longer find any article relevant to their practice is a efficacy in a setting characterized by the clinician’s full
problem that is worthy of attention. In fact, part of the availability for specific times, the patient’s opportunity to
challenge and, at the same time, fascination of being a ventilate thoughts and feelings, the development of a pa-
clinician lies in applying the scientific method to the care tient-doctor interaction and the perception of competent
of patients and in understanding of disease [44]. In- care [23, 52–54]. When these therapeutic ingredients are
creased knowledge would result in significant benefits for missing, drugs are unlikely to be superior to placebo [56],
the patients, and in a sense of continued development on simply because drug-induced effects cannot be separated
the part of the physician. from other therapeutic ingredients. Efforts to study the
The intellectual crisis in clinical research is not spe- role of nonspecific factors in determining the response to
cific to psychiatry, but pervades all medical specialties acute and long-term treatment have always been mini-
[45–47]. Alvan Feinstein [45] attributed its main root to mal. One may wonder what could be the consequences,
the decline of clinical medicine as the source of funda- in terms of economic waste, mortality and morbidity, of
mental scientific challenges, which took place after World a clinical management by young generations of psychia-
War II: ‘The preclinical sciences became detached from trists nurtured by evidence-biased psychiatry, meta-anal-
their clinical origins and were converted into “basic bio- yses, overselling of drug-related ingredients of modest ef-
medical sciences” with goals that often no longer aimed ficacy and the neglect of other therapeutic factors [40].
at mechanisms of disease, with investigators who often The recent findings of the largest depression treatment
had no clinical training or responsibilities, and with re- trial, the STAR*D, provide a dramatic illustration of the
sults that often had no overt relationship to clinical phe- difficulties in recovering from depressive illness [57]. The
nomena’ [48, p 216]. Clinicians were thus urged to apply aim of the trial was to apply the best pharmacological
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strategies for obtaining remission in major depression. A 3 studies [67–69], the follow-up lasted up to 6 years. The
sample of 3,671 patients was treated with citalopram in rationale of this sequential approach was to utilize cogni-
an open fashion: only 36.8% of patients were remitted tive behavioral treatment resources when they are most
[57]. Those who did not recover were submitted to 4 se- likely to make a unique and separate contribution to pa-
quential steps involving switching, augmentation and tient well-being and to achieve a higher degree of recovery,
combination strategies. The results were rather disap- since standard forms of treatment based on monotherapy
pointing. The cumulative rate of remission after 4 se- seem to be insufficient for most depressed patients [70].
quential steps was 67% [53]. However, when sustained re- The data about the usefulness of evidence-based psy-
covery (taking into account relapse rates while on treat- chotherapy for obtaining lasting remission in mood and
ment) was considered, the cumulative rate was 43% [58]. anxiety disorders [66, 71] have led to the funding and de-
This means that strenuous efforts yielded only an addi- velopment of psychological treatment centers within the
tional 6% of sustained recovery, and indicates the failure National Health System in the UK [72]. This landmark
of current pharmacological strategies in determining initiative offers a dramatic example of the relegation of
lasting remission in depressed patients [59]. the psychiatrist to a marginal role. In fact, in these psy-
Other studies had indicated the failure of mental chological treatment centers, a senior nonphysician psy-
health specialists to improve the outcome of depression chotherapist would make initial diagnoses and assign the
in the primary care setting. Simon et al. [60] compared patient to a junior therapist, who would be supervised,
the 6-month outcome in depressed patients receiving an- motivated and trained by senior therapists [72]. Psychia-
tidepressant prescriptions either from psychiatrists or trists would be elsewhere in the National Health System,
primary care physicians. The 2 groups showed similar with the task of administering drug treatment to the most
rates of improvement in all measures of symptom sever- severely ill patients, and would not be involved at all in
ity and functioning. Similar results were obtained with the treatment of most mood and anxiety disorders.
the collaboration of primary care physicians and mental Pharmaceutical psychiatry is indeed leading to a mar-
health consultants [61], implementation of clinical prac- ginal role of the specialty in the medical system and to a
tice guidelines [62], and randomization to a relapse pre- perceived restriction of the psychiatrist’s role to prescrib-
vention program or usual primary care [63]. The findings ing and signing forms, limiting opportunities to engage
indicate that the average depressed patient has no better in the kind of integrated care that attracted many physi-
chance of getting and remaining well with the psychiatric cians to the field [73]. The need for a substantial renewal
specialist than with his/her primary care physician. of psychiatry to counteract its decline is then more and
more obvious.
The term ‘psychological medicine’ is currently used
The Emerging Role of Psychological Medicine with different meanings, particularly in the UK, despite
the presence of a well-established journal [74] and aca-
An increasing body of evidence links the progression demic chairs. In a restrictive sense, it is used as a syn-
of several medical disorders to specific lifestyle behaviors onym of liaison psychiatry, to indicate ‘the type of work
[54]. Half of the deaths that take place in the USA can be practiced by psychiatrists based in general hospitals’ [75,
attributed to ‘largely preventable behaviors and exposure, p 6]. A much broader meaning has been suggested by
such as tobacco smoking, obesity and physical inactivity’ Kroenke [76]: the study and practice of the psychological
[64]. It is ironic that, while psychiatrists tend to view aspects of medical assessment and treatment [77–79].
treatment and prevention of relapse of depression purely This definition of psychological medicine has consider-
in pharmacological terms (as if it were a disease such as able overlaps with that of psychosomatic medicine [54],
diabetes), diabetologists, as other medical specialists, em- which is more prevalent outside of the UK. Both defini-
phasize the importance of nonpharmacological strategies tions of psychological medicine emphasize the role of
[65]. psychiatry in general medicine, and not vice versa, unlike
In the past decade, several studies have supported the psychosomatic medicine [54]. John Ryle [80], one of the
usefulness of cognitive behavioral strategies (including most eminent physicians of the past century, argued that
lifestyle modification and/or cognitive restructuring and half of practical medicine is actually psychology, and
increasing coping skills and/or promotion of psychologi- viewed psychological medicine not as a medical special-
cal well-being) after successful pharmacotherapy for de- ty, but as an extension of the psychological vocation of
creasing the likelihood of relapse during follow-up [66]; in the physician. Psychological medicine was inextricably
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linked to medical ethics and to the physicians duty to pa- such a threshold may be discarded, whereas there is in-
tients, community, colleagues and science [81]. In 1976, creasing evidence on the high prevalence and prognostic
Halsted Holman [82] argued against the increasing re- value of residual symptomatology and on the potential
ductionism, which neglected the impact of nonbiological benefits, in terms of long-term outcome, of achieving a
circumstances upon biological processes. The remarks of higher degree of remission [70].
Holman [82] were one of the key inspirations of 1977 pa- The final major innovative aspect of the model of
per on the biopsychosocial model by George Engel [83]. Engel [83] was the fact that all diseases, whether placed
Interestingly, of this highly cited paper, only the multifac- in the medical, surgical or psychiatric domains, require
torial frame of reference was generally referred to [84]. a comprehensive and multidisciplinary approach. As
However, there were 3 innovative aspects which are still Kroenke [76, p 1537] commented 25 years later: ‘neither
waiting for adequate consideration and underlie the con- chronic medical nor “psychiatric” disorders can be man-
cept of psychological medicine, which was indeed present aged adequately in the current environment of general
in the Rochester group [44, 85]. practice, where the typical patient must be seen in 10–15
The first was the dangerous connection between med- minutes or less. The quick visit may work for the patient
ical reductionism and the financial aspects of medical with a common cold or a single condition, such as a well-
research and practice, which would have been later sub- controlled hypertension, but will not suffice for the prev-
sumed under the rubrics of conflict of interest and special alent and disabling symptoms and disorders …’. The in-
interest groups [4]. Engel criticized medical schools which creasing awareness of the issue of comorbidity in psychi-
‘have constituted unreceptive if not hostile environments atry [93, 94] and medicine [95, 96] is a good reminder of
for those interested in psychosomatic research and teach- this complexity.
ing’ and medical journals which ‘have all too often fol- The concept of psychological medicine, defined as the
lowed a double standard in accepting papers dealing with clinical application of the psychosomatic approach [54,
psychosomatic relationships’ [83, p 139]. 83, 84], may provide room for innovative paths in psychi-
The second issue was his unified concept of health and atric research and treatment. It is not a prerogative of psy-
disease [86]. Positive health is often regarded as the ab- chiatrists, but encompasses clinical activities of other
sence of illness, despite the fact that, half a century ago, physicians (internists, family doctors, etc.), psycholo-
the World Health Organization defined health as a ‘state gists, social workers, nurses and practitioners of other
of complete physical, mental and social well-being and medically aligned disciplines. As such, it emphasizes
not merely the absence of disease or infirmity’ [87]. Ryff multidisciplinary team work for treating mental disor-
and Singer [88] remark that, historically, health has been ders. Fava et al. [73] outlined a new model of a mental
equated with the absence of illness rather than the pres- health clinic based on the concept of psychological med-
ence of wellness. As a result, assessment in psychiatry is icine. The basic unit would consist of a psychiatrist, an
mostly based on appraisal of psychopathological dys- internist and 4 clinical psychotherapists, who may pro-
function, instead of a balance between positive and nega- vide evidence-based psychotherapy after the initial eval-
tive affects. If treatment of psychiatric symptoms induces uation by a psychiatrist.
improvements in well-being (subscales measuring well- Psychological medicine derives its identity from sev-
being are more sensitive to drug effects than subscales eral converging developments over the traditional psy-
describing symptoms [89]), it is also true that changes in chiatric approach. In the current psychiatric model,
well-being may affect the balance of positive and negative which is endorsed in many contexts worldwide, a diagno-
affects [40]. Not surprisingly, the relevance of current ep- sis and treatment plan that are usually formulated after a
idemiological studies for identifying the potential for single initial visit are supposed to be followed in the sub-
breakdown in the apparently healthy individual has been sequent months or years without any additional time for
questioned [90]. Ryff and Singer [88] suggest that the ab- reevaluation. This approach is based on a unidimension-
sence of well-being creates conditions of vulnerability to al cross-sectional view of the disorder, as the one entailed
possible future adversities, and that the route of recovery by the DSM, assuming that the illness does not evolve and
lies not exclusively in alleviating the negative, but in en- the diagnosis does not change over time. However, it is
gendering the positive. However, there has been very little not uncommon for apparently clear-cut major depression
research effort in this direction [91, 92]. Diagnostic crite- to be rediagnosed as bipolar disorder [97–99] because the
ria set a threshold whereby psychiatric disorders can be prodromes of the manic episode were overlooked or
identified and differentiated. Symptoms that do not reach masked at the initial assessment. Psychological medicine
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thus relies on repeated assessments, in line with the Eu- A final characteristic of psychological medicine lies in
ropean tradition of psychopathology [100], from various its humanistic and ethical standpoint, as exemplified by
viewpoints (including medical evaluation) [59, 101]. Fur- eminent physicians such as Alvan Feinstein [48], John
ther, it recognizes that for most patients a single course of Ryle [80, 81], Halstead Holman [82], George Engel [83]
treatment is insufficient for yielding adequate improve- and Robert Petersdorf [110]. The supporters of the con-
ment, and that different combined or sequential ap- cept of psychological medicine should follow those stand-
proaches may be necessary. The psychiatric paradigm points, and be devoid of a ‘substantial conflict of interest’,
still endorses the conviction that psychotropic drugs as recently defined [4].
work by acting on a disease process, which the propa-
ganda translates into ‘curing’ psychiatric disease. How-
ever, there is substantial evidence to call such views into Conclusions
question, including nonspecific effects, studies with
healthy volunteers and animal tests [23, 59, 102]. Mon- It is difficult to disagree with the statement that there
crieff and Cohen [102] advocate a drug-centered model is ‘no health without mental health’ [8]. However, if men-
that would place more emphasis on subjective experi- tal health is the type that is purported by pharmaceutical
ence, developing outcome measures addressing particu- psychiatry (i.e. the increased consumption of psychotro-
lar behaviors rather than disorders, overcoming the dis- pic drugs), it would be justified to endorse the statement
tinction between therapeutic and adverse effects, and of Melville’s Bartleby: ‘I would prefer not to.’
evaluating patients’ comparative preferences for different Tinetti and Fried [111] have argued that the time has
types of drugs in various situations. The placebo response come to abandon disease as the focus of medical care. The
appears to be a much more complex issue than it is cur- notion of psychiatric disease is also not in line with the
rently assumed in psychiatry [103], and its exploration changed spectrum of health and the complex interplay of
may yield new insights. biological and psychosocial factors [40, 102, 111]. Phar-
The psychosomatic concept related to the biological ef- maceutical reductionism leads to undertreatment, over-
fects of psychological methods [37] has found an increas- treatment or mistreatment, and does not entail a solution
ing body of support from studies exploring the neurobio- to the complexity of clinical situations. The concept of
logical correlates of psychotherapy [104]. Psychological psychological medicine may renew the psychiatric field
medicine relies on the mobilization of healing forces in and provide ‘the wisdom to venture off the beaten path of
the sufferer by psychological means, including psycho- exclusive reliance on biomedicine as the only approach to
therapy [105, 106], and is thus in line with the increasing health care’ [83, p 135].
appreciation of self-management in chronic medical dis-
eases [76, 82] and psychiatric disorders [107–109].

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