IS PSYCHIATRY FOR SALE?
AN EXAMININATION OF THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY ON ACADEMIC AND PRACTICAL PSYCHIATRY.
BY
JOANNA MONCRIEFF
Published June 2003
This was prepared as a MAUDSLEY DISCUSSION PAPER
and is available for £4 as a booklet from the Sarah Smith at the
Institute of Psychiatry, de Crespigny Park, London SE5 8AF, tel 0207836
5454, e mail sarah.smith@iop.kcl.ac.uk
SUMMARY
Western society is consuming ever larger
quantities of prescription drugs and many of these are for psychiatric
complaints. Drugs are central to modern psychiatric practice and to much
psychiatric thought about the nature and causation of mental disorders.
Psychiatry has therefore become an important target for the large and
powerful pharmaceutical industry. Drug companies direct lavish
advertising and hospitality towards psychiatrists and provide funding
for much medical education and some mental health service initiatives.
The industry is now heavily involved in the organisation of research
into psychiatric drugs and the dissemination of research findings. This
raises questions about the scientific objectivity of this research and
the extent to which the industry is able to shape the research agenda.
Drug companies also provide funds for pro drug patient and carer groups
and address advertising or disease promotion campaigns to the general
public. They exert influence at a political level through lobbying and
direct funding of political bodies including drug regulatory agencies.
This influence has helped to create and reinforce a
narrow biological approach to the explanation and treatment of mental
disorders and has led to the exclusion of alternative explanatory
paradigms. The coercive function of psychiatry has been strengthened by
promoting the idea that psychiatric disorders are akin to medical
conditions and that they are amenable to technical solutions in the form
of drugs. In addition, alternative treatment approaches are neglected
and it is likely that drugs are currently used for overly long periods
and in excessive doses. The adverse effects of drugs are neglected.
Psychiatry provides fertile ground for pharmaceutical
industry profits because it provides opportunities for expanding
definitions of sickness to include more and more areas of social and
personal difficulty. This paper gives examples of how the industry has
been involved in promoting and expanding concepts such as depression,
social phobia, attention deficit hyperactivity disorder and psychosis.
The current extent of drug company influence
threatens the integrity of psychiatry and some suggestions are made
about steps that could be taken to address this. The influence of the
industry must be curbed for political reasons too. We are rapidly
becoming a society that seeks a "pill for every ill;" one that looks for
simplistic, technical solutions to complex social problems. This helps
to divert attention away from the profound social and political changes
that have occurred during the last few decades. Psychiatrists should not
be colluding in this process.
BACKGROUND
The place of drug treatment in modern psychiatry
Drugs are the central focus of treatment in
modern day psychiatry. The vast majority of psychiatric inpatients are
prescribed at least one psychoactive drug and many are on several. The
same is true for only a slightly smaller proportion of psychiatric
outpatients and many more people are prescribed psychoactive drugs,
especially antidepressants and benzodiazepines, in General Practice.
Furthermore, most patients who are prescribed psychiatric drugs are told
to take them for a period of months, and many are told that they will
need to take them for many years or even for life. Psychiatric textbooks
devote large sections to drug treatment and related aetiological
theories and psychiatric journals are filled with results of drug trials
and related brain research.
Almost all drugs in current use have been introduced
into psychiatry since the 1950s. Although drug treatment was common
before that time, with extensive use of barbiturates and other sedatives
and some use of stimulants, it was rarely given much attention. This
was because drugs were generally regarded as having only crude effects,
usually acting as chemical forms of restraint (Braslow, 1997). However,
from the 1950s, drug treatment came to be seen as important and
glamorous. The drugs that were introduced from that time onwards came to
be regarded as specific treatments for specific conditions and became
the basis for speculations about the aetiology of mental illness
(Moncrieff, 1999). A vast research into possible abnormalities in
transmitter and receptor systems was spawned, epitomised by the dopamine
theory of schizophrenia and the monoamine theory of depression.
The pharmaceutical industry undoubtedly played an
important part in establishing drug treatment as central to psychiatry.
It was involved from the beginning of the "psychopharmacological" era,
for example with the huge marketing campaign that helped to introduce
chlorpromazine (Thorazine) into America in the mid 1950s (Swazey, 1974).
The industry has been described as the "ultimate force behind the
adoption of new drugs such as chlorpromazine" and credited with
transforming psychiatry into a genuine and modern medical specialism
(Shorter, 1997).
Recent developments
Over the last ten to fifteen years psychiatric
drugs have become much more widely prescribed and increasingly familiar
to the general public. Drugs such as Prozac and Ritalin have become
household names and books about them have become best sellers (Kramer,
1993). This is part of a more general increase in consumption of all
types of medicines, indicated by the fact that prescriptions issued
increased by 56% between 1988 and 2001 in the United Kingdom. The
average the number of annual prescriptions per head of population
increased from 8 to 12 in the same period. However, increases in the use
of psychotropic drugs have contributed disproportionately to this
increase, with prescriptions of antidepressants rising by 173% in the
ten years between 1991 and 2001 (Department of Health, 2002). The rise
in cost has been even more marked since the majority of the increases in
prescribing have been for expensive new classes of psychiatric drugs
such as the Selective Serotonin Re-uptake Inhibitor (SSRI)
antidepressants and the "atypical" antipsychotics. In the United States
antidepressants are now the top selling class of prescription drug, with
antipsychotics, anti-anxiety agents and stimulants all also ranking
highly and/or showing rapidly increasing sales (National Institute of
Health Care Management, 2002).
This increase in use of prescribed drugs has been
achieved firstly by extending the boundaries of well recognised
conditions like depression and psychosis. Secondly, lesser known
disorders such as panic disorder and social phobia have been publicised,
and thirdly, drug treatment has started to colonise areas where it was
previously thought to be unhelpful such as substance misuse and
personality disorder.
INFLUENCE OF THE PHARMACEUTICAL INDUSTRY
Over the 20th century pharmaceutical
companies transformed themselves from small enterprises, often the
offshoot of chemical companies, into some of the largest commercial
concerns in the world. By the beginning of the 21st century
they were making greater levels of profit than their counterparts in
other commercial sectors (see Figure 1). In 2001, US pharmaceutical
company profits averaged 18.5% of revenue compared with 2.2% for the
rest of the Fortune 500 companies (Fortune magazine, April, 2002).
The Pharmaceutical industry exerts its influence at many different levels:
- The Medical Profession
The medical profession is the industry’s primary
target. Routine marketing strategies include the provision of
"hospitality" which can vary from the provision of lunchtime
refreshments for local meetings to the financing of meals in expensive
restaurants or the provision of expenses paid trips to attractive
foreign locations for company presentations. When psychiatrists refuse
to see company representatives, they may persuade other members of the
mental health team to accept hospitality. The provision of small gifts
to doctors such as mugs, pens, books and diaries is also endemic. Drug
company logos adorn many psychiatrists’ offices and are encountered
throughout psychiatric hospitals and wards.
Many medical educational events such as conferences
now receive substantial income from commercial sources. In a recent
article, respected American psychiatrist E. Fuller Torrey described the
extravagant promotional methods employed at the 7th World
Congress of Biological Psychiatry held in Berlin in 2001. Several drug
companies constructed elaborate installations to attract delegates’
attention. These included an artificial garden (Janssen-Cilag), a
running stream (Lundbeck), a 40-foot rotating tower (Novartis) and a
tent with costumed women offering fortune telling (Organon) (Torrey,
2002). The drug companies had also sponsored more than half of the
conference delegates, paying for airfares, accommodation and
entertainments and paid fees of between $2000 and $5000 to the speakers
at the numerous industry sponsored symposia. In all, the conference was
said to have cost the industry at least 10 million dollars (Torrey,
2002). This is not so extraordinary. The American Psychiatric
Association and UK Royal College of Psychiatrists annual conferences
have also come to resemble trade fairs due to the prominence of drug
company stands.
It has been repeatedly shown that doctors prescribing
practices are influenced by interaction with industry representatives
and attendance at drug company sponsored events (Wazana, 2000). The fact
that the industry invested $15.7 billion in marketing in 2000, and that
in the United States there is about one drug rep per 15 doctors, also
indicates the importance the industry attaches to its marketing
activities (Shaunessy & Slawson, 1996, BMJ).
Organisation of research
- Medical research
In the 1960s large clinical trials were
funded by state funds through the NIMH in the United States and the MRC
in the UK. At that time there was a belief that the commercial sector
should play only a limited role (Healy, 2002). However, the industry now
underwrites 70% of research into drug treatments (Bodenheimer, 2000).
In addition most drug trials in United States are now conducted by
commercial research organisations, called Contract Research
Organisations. These organisations have emerged recently and hire out
their services to drug companies. Thomas Bodenheimer describes a
situation in which hundreds of commercial research organisations as well
as academic medical centres and other independent non academic sites
compete with each other for contracts to do industry funded research
(Bodenheimer, 2000). Obviously if the studies do not achieve the desired
results, the organisation may jeopardise future contracts. In addition,
payment is usually awarded according to how many patients are entered
into the trial, creating the incentive to stretch and expand diagnostic
concepts. Evidence suggests that commercial research organisations
conduct research more rapidly and more cheaply than academic medical
centres (Commonwealth Fund, 1999). Bodenhemier (2000) concluded that
"trials conducted in the commercial sector are heavily tipped towards
industry interests."
Contract Research Organisations have argued that they
are heavily regulated and have to follow internationally agreed Good
Clinical Practice guidelines on the ethical and safe conduct of research
(Beach, 2001). However, a few years ago, figures revealed by one audit
company suggested that compliance with guidelines was frequently
inadequate (Boyhachuk & Ball, 1999). Since audit results are not
routinely published it is impossible to know whether this situation has
improved or not. A recent audit of 17 Contract Research Organisations in
Germany suggested quality was generally high but 31 cases of
significant deviations from Good Clinical Practice guidelines were still
found (Chase et al, 2001). In any case it may be difficult to detect
the subtle influences that commercial pressures have upon the research
process.
The case of Borison and Diamond, who were
psychiatrists who set up a Contract Research Organisation in the United
States, revealed the huge profits that can be made in this business.
They were convicted of defrauding the University where they were
employed. The investigation revealed not only their huge personal
wealth, but also that large bonuses were paid to staff who enrolled the
most patients and that patients were also offered cash inducements.
Although Borison and Diamond were not indicted for research fraud,
revelations about the operation of their business sheds a worrying light
on the conduct of trials in the current highly competitive climate.
Borison was, incidentally, principal investigator in two of the pivotal
trials that led to approval of the atypical antipsychotic risperidone in
the United States (see Whitaker, 2002, chap 11).
At an individual level, links between academic
doctors and the industry are proliferating and include payment for
speaking at conferences, consultancy fees, payment for sitting on
advisory boards or boards of directors, and holding equity in a company
(Boyd & Bero, 2000). A study of published papers found that 34% of
primary authors had substantial financial interests in the work they
published (Wadman, 1997). In psychiatry the situation may be even worse.
In 2000, the New England Journal of Medicine did not have space to
print all the financial interests of the authors of a paper on the
antidepressant nefazadone and had great difficulty in identifying an
academic psychiatrist to write an editorial on the subject who did not
have financial ties with companies that make antidepressants (Angell,
2000).
It was also shown recently that 87% of authors of
clinical practice guidelines had some interaction with the
pharmaceutical industry, and 38% had served as consultants or employees
of companies. Despite this, only 4.5% of guidelines contained any
declaration of the personal financial interests of authors (Choudhry et
al, 2002). This is a cause of concern since guidelines usually command
professional respect and have a strong impact on practice.
Research findings
Research findings can be effected both by the
way a study is designed and by the way results are presented. The fact
that drug firms now control most of the process of most clinical trials
from design and implementation through to data analysis and publication
is therefore a cause of concern for some commentators and researchers
(Bodenheimer, 2000; Healy & Cattell, in press; Bero & Rennie,
1996).
The design of studies is a particular issue in
psychiatry where disorders are highly variable and in most cases wax and
wane, meaning it is easy to be deceived about the benefits of
intervention. The history of psychiatry is full of treatments that were
thought to be effective scientific treatments but turned out to be
useless, not to mention harmful (for example see Whitaker, 2002, chapter
4, on the history of Insulin Coma Therapy). Although there is a
consensus that psychiatric drugs including antidepressants,
antipsychotics and mood stabilisers are effective and useful, problems
with the design of studies means that questions remain about the
reliability of some of the evidence base for this consensus. In
antidepressant trials, problems such as the subjectivity of outcome
measures and unblinding, have lead several authors to conclude that
their efficacy is not firmly established (Antonnucio et al, 1999;
Moncrieff , 2001). It has been suggested that the apparent benefits of
atypical antipsychotics in relation to side effects were partly a result
of comparison with high doses of standard drugs, which were popular at
the time the atypicals were first introduced (Geddes et al, 2000). In
addition, studies of long-term treatment have neglected the possibility
that withdrawal related problems in people who stop drugs may inflate
the apparent benefits of drugs such as lithium (Suppes et al, 1991) and
antipsychotics (Baldessarini & Viguera, 1995).
The results of studies can be presented in a number
of ways to give an exaggerated view of a drugs benefits (Bero &
Rennie, 1996). These include failure to publish negative results, the
use of multiple outcome measures, and selective presentation of ones
that are positive, multiple publication of positive study results, and
the exclusion of subjects from the analysis. For example, one review of
psychotropic drug trials reported that hundreds of significance tests
were conducted and that 50% of trials excluded subjects from the
analysis (Hemminki, 1981).
These problems are not confined to studies conducted
by the pharmaceutical industry, but it seems likely that commercial
pressures may increase the risk of methodological biases and misleading
reporting. In Bodenheimer’s investigation 6 out of the 12 clinical
investigators he interviewed reported cases in which publication of
papers had been blocked, or the content of papers altered by a drug firm
(Bodenheimer, 2000). Peter Breggin’s analysis of FDA files claimed that
several negative studies of fluoxetine (Prozac) were not published and
that some published trials did not report negative outcomes (Breggin
& Breggin, 1995). A recent review of company sponsored comparative
drug trials for psychiatric disorders describes how various design and
reporting modifications were apparent that appeared to serve the
company’s marketing objectives (Safer, 2002). The author describes
instances of the use of inappropriate doses of comparator drugs, use of
questionable definitions of outcome, the selection of major findings and
end-points post hoc, the masking of unfavorable side effects, duplicate
publication, emphasising favorable but not statistically significant
differences, withholding unfavourable results and masking sponsorship.
Indirect evidence that drug company sponsorship
effects trial quality is the finding that studies sponsored by drug
companies are more likely to find evidence in favour of the sponsor’s
product than studies that do not have commercial sponsorship. Research
conducted in the 1980s found that 43% of trials that favoured a new
therapy were sponsored compared with 13% that favoured the standard
therapy or placebo (Davidson, 1986). A recent study found that authors’
conclusions were more likely to be favourable towards an intervention
where the study was fully funded by a for-profit organisation than where
funding came from other sources (Kjaergard & Als-Nielson, 2002).
Drug company sponsorship was associated with greater apparent benefit
from the company’s drug in trials of clozapine (Wahlbeck et al, 2000)
and antidepressants (Freemantle et al, 2000).
The research agenda
The extent of drug company funding for
research and the interactions between academic personnel and the
industry mean that much research activity is oriented towards drug
treatments and related areas.
In addition, marketing strategies now include
attempts to shape psychiatric thought through the academic arena. This
is done by a strategy that is conceived long before a product is
officially marketed and may involve the promotion of disease concepts
and their frequency. A recent guide to pharmaceutical marketing suggests
the need to "create dissatisfaction in the market," "establish a need,"
and "create a desire". A portfolio of articles which promote the
disease concept in question and/or the company’s product is constructed
for the medical audience. The articles will often be written by a
medical writing or education agency and then academic authors will be
approached to become authors, a practice known as "ghost writing."
Medical "opinion leaders" are also identified and cultivated as part of
this strategy to act as "product champions" (Pharmaceutical Marketing,
2002).
Evidence suggests this practice is not uncommon, with
one study finding that 11% of articles in 6 major peer reviewed
journals involved the use of ghost writers (Flanagin, 1998). A recent
study of articles on the therapeutics of the antidepressant sertraline
found that over half were produced by a medical information company
employed by Pfizer Pharmaceuticals. These articles had higher citation
rates and a higher profile within the medical literature than articles
written independently (Healy & Cattel, in press).
Advertising in major academic journals provides
another mechanism for influencing the message that reaches the public
domain. Drug advertisements are now a prominent feature of major British
and American psychiatric journals. A typical issue of the American
Journal of Psychiatry consisting of about 200 pages of scientific
content has around 35 pages of drug advertisements and a further 18
pages of adverts for drug company sponsored "educational" meetings (see
for example May 2002 and Jan 2002). Issues of the British Journal of
Psychiatry in 2002 had between 5 and 16 pages of advertisements for
around 100 pages of scientific content.
In the 1960s a United States Congress investigation
revealed that editors of some journals were allowing drug companies that
were contributing advertising revenue, to advise rejection or
alteration of articles that were unflattering to their products (Frank
Ayd interveiwed in Healy, 1996). Recent cases involve papers concerning
the dangers of the sleeping tablet Halcion (Ian Oswald, interviewed in
Healy, 2000) and a paper reporting adverse effects of SSRIs (reported in
Valenstein, 1998, chap 6, P191-2). Although many editors are making
substantial efforts to make potential influences on research more
transparent by requiring "conflict of interest" declarations by authors,
it remains a concern that journals that receive a substantial amount of
revenue from drug company advertising may be endangering their
impartiality.
3) The Public and Patient Groups
In the United States and New Zealand, drug
companies are permitted to advertise their products directly to
consumers. Figure 2 shows that in the year 2000 alone, 2.5 billion dollars
was spent on advertising prescription drugs to consumers in the United
States (Public Citizen, 2002). In 1999, it was estimated that the
average American saw nine adverts for drugs every day (market research
quoted in Mintzes, 2002). Non compliance with advertising standards and
regulations is common. The Food and Drug Administration in the United
States reported that 1 in 4 advertisements violated their regulations
(Aitkin & Holt, 2000) and higher levels of non compliance have been
reported from New Zealand (Medawar, 2001). The pharmaceutical industry
has also been trying for some years now to introduce direct to consumer
advertising into Europe (Medawar, 2001). In 2000, the then director of
the Association of the British Pharmaceutical Industry described how
"the ABPI battle plan is to employ ground troops in the form of patient
support groups, sympathetic medical opinion and healthcare
professionals….which will lead the debate on the informed patient issue.
This will have the effect of weakening political, ideological and
professional defences." (Pharmaceutical Marketing, 2000). After lobbying
by industry and industry funded patient groups, the European Commission
proposed some limited reduction in restrictions on advertising to
consumers. Although the European Parliament overwhelmingly rejected
these proposals, they have not been shelved and are now being considered
by the European Council of Ministers (Medawar, personal communication,
May 15th 2003).
There is no doubt that direct to consumer advertising
leads to increased prescription of drugs. A recent survey showed that
one in five Americans was prompted to call or visit their doctor to
discuss an advertised drug (British Medical Journal, BMJ, News, 19th
October, 2002). Mintzes et al (2002) showed that exposure to
advertising lead patients to request more drugs, and that these requests
were usually complied with despite doctors reservations about the
appropriateness of the treatment. Drug company promotion to the public
includes disease awareness campaigns that can be run in countries that
do not permit direct to consumer advertising as well as those that do.
Patient groups are recruited to give the campaign a human face and
supply stories for the media. In some cases high profile celebrities
have been included to help the campaigns reach prime time television
audiences (BMJ News, 1st June, 2002).
Relationships with patient groups is another channel
of influence for the industry. In some instances patient groups appear
to have been set up by drug companies. The American magazine, Mother
Jones found that the Social Anxiety Disorder Coalition, the Post
Traumatic Stress Disorder Alliance and the National Mental Health
Awareness Campaign operated out of public relations firms hired by drug
companies. They appeared to have been set up for the purposes of disease
awareness campaigns (Mother Jones, 2002). Two international groups are
also linked to the industry and have been active in lobbying the
European Commission to introduce direct to consumer advertising. IAPO
(International Alliance of Patients Organisations) was founded and is
funded by Pharmaceutical Partners for Better Healthcare, a consortium of
about 30 companies, and GAMIAN (Global Alliance for Mental Illness
Advocacy) was originally founded by Bristol Myers Squibb. Neither
discloses its current sources of funding (Herxheimer, draft).
As well as setting up new groups, the industry is
increasingly acting in co-operation with existing groups of patients and
carers. In the mental health field it gives funding to groups that
promote biological views of mental illness and drug treatments,
including the National Alliance for the Mentally Ill (NAMI) and the
National Mental Health Association in the United States and SANE and the
Depression Alliance in the UK. It often gives funding for these
organisations to run specific campaigns aimed at increasing the number
of people seeking treatment. An example is the current CHADD (Children
and Adults with Attention Deficit Disorder) campaign to extend diagnosis
and drug treatment into under-served communities (see below).
- Political Institutions
John Abrahams (2002) has described the process
whereby European and American drug regulatory agencies became more
responsive to the needs of the pharmaceutical industry. This was
achieved by increasing the reliance of these agencies on funding from
the industry through license applications, and reducing state support.
As a consequence there has been a strong emphasis on reducing drug
approval times. In the UK these have shrunk from 154 to 44 days since
the changes came into force when the Medicines Control Agency was formed
in 1989.
The industry is also increasing its influence
over central government policy in the United Kingdom through recently
established government bodies such as the Pharmaceutical Industry
Competitiveness Task Force, the Industry Strategy group and partnerships
with health service bodies. The National Institute for Mental Health
England (NIMHE) and the pharmaceutical industry, represented by the
Association of the British Pharmaceutical Industry (ABPI), recently
announced a formal partnership. The first production of this partnership
is a compendium describing collaborative projects around the country
entitled "Meeting of Minds." These projects are diverse and include the
publication of guidelines, audit packs, toolkits, websites, directories
and funding additional personnel including a pharmacist and a primary
care liaison worker (NIMHE & ABPI, 2002). Many of the projects
undoubtedly contain valuable information and advice, but there must be a
concern that projects such as the development of guidelines for the
treatment of schizophrenia, and projects designed to improve recognition
of depression in primary care might over-emphasise the role of certain
drug treatments. However, the main concern about these projects, and the
NIMHE statement that it "expects that partnership with the industry
will become routine in the development and implementation of mental
health policy," is that incorporating the industry into the fabric of
the health service in this way increases its influence enormously and
may make it very difficult to identify and resist commercial pressures.
There seems to be little acknowledgement that there might be conflicts
of interest between the aims of industry and those of a public service.
In Scotland concerns have been raised about the level
of financial interests of members of the newly established Scottish
Medicines Consortium (Sunday Herald, 13th February, 2003).
This body was set up to try to advise the Scottish Executive on National
Health Service drug expenditure. More than half the members were
revealed to have personal or non-personal (research grants) financial
interests in the pharmaceutical industry.
The industry also seeks direct influence at a
parliamentary level by employing political lobbyists and contributing
large sums of money to political parties and campaigns. In the United
States, there are more pharmaceutical industry lobbyists than Congress
members. The lobby budget for 1999 and 2000, at 197 million dollars, was
50 million dollars larger than the drug industry’s nearest rivals, the
insurance and telecommunications industries. On top of this the industry
makes generous contributions to election campaigns, mostly to
Republican Party candidates (New York Times, 4th November, 2001).
ADVERSE EFFECTS ON PSYCHIATRY
So how does all this influence effect psychiatry
and why should we be concerned about it? The alliance between psychiatry
and the pharmaceutical industry has several important negative
consequences. Firstly, it helps to reinforce a narrow biological
conception of the nature of mental disorder. Secondly, it drives the
expansion of this conception into more and more areas of everyday life.
Thirdly, it is likely to play down the impact of the adverse effects of
psychiatric drugs.
I THE PROMOTION OF BIOLOGICAL PSYCHIATRY
Explanatory paradigms in psychiatry
Psychiatry as an institution has long been
obsessed with identifying biological causes of mental disorders and with
the narrow technical solutions that flow from such a paradigm
(Moncrieff & Crawford, 2001). The pharmaceutical industry has helped
to reinforce this approach by the promotion of drug treatments, funding
biological research and by promoting claims that psychiatric disorders
are caused by simplistic biological notions such "chemical imbalances."
Although the Food and Drug Administration in the US prohibits such
claims in advertisements that mention individual drugs, because they are
not regarded as sufficiently established, they can be made in other
promotional material. In 1995, the pharmaceutical industry provided
funding for a campaign in the United States organised by the National
Alliance for Research on Schizophrenia and Depression, entitled
"Depression, a flaw in chemistry not character". This was an offshoot
organisation formed by the National Alliance for the Mentally Ill
(NAMI), and two other patient advocacy groups from the US, which also
receive other financial support from the pharmaceutical industry.
Advertisements in the national press and leaflets distributed as part of
this campaign asserted that depression had been shown to be due to "an
insufficient level of the neurotransmitter serotonin ....in the frontal
lobes of the brain" (reproduced in Valenstein, 1998, chap 6, P 178). The
pharmaceutical industry has also taken up this theme in its own
promotional material. Eli Lily asserted that "like arthritis or
diabetes, depression is a physical illness" (reproduced in Valenstein,
1996, chap 6, P 181).
The hegemony of biological psychiatry that now exists
stifles other approaches to understanding the complex behaviours that
constitute psychiatric conditions. It elevates quantitative positivist
research methods, borrowed from the natural sciences. This approach
depends on the notion that psychiatric conditions can be conceptualised
as discrete entities occurring in individuals, which can be defined
independently of their social context. Other philosophical and
sociological approaches that seek to understand the meaning of
psychiatric disorders at both an individual and social level are
relegated to the fringes of psychiatric academia. The biological
hegemony has consequences at a social and political level too. By
locating the problem as a disease within an individual brain, biological
psychiatry diverts attention away from the social and political
conditions that help to determine how psychiatric disorders occur and
how they are identified and defined (Conrad, 1992).
Psychiatry and coercion
The alliance between psychiatry and the drug
industry also helps to strengthen the more coercive aspects of
psychiatry. The coercion enshrined in much Mental Health legislation is
justified on the basis that psychiatric conditions are discrete medical
entities that respond to specific treatments. The planned extension of
coercion into the community in the new Mental Health Bill for England
and Wales is based on the simplistic idea that if patients would only
comply with their drug treatment all would be well. However, it is
acknowledged that a substantial proportion of patients with psychosis,
for example, fail to make even an initial response to drugs and many
more relapse despite ongoing drug treatment (Crow et al, 1986; Gilbert
et al, 1995; Adams et al, 2001). Despite this reality, the dominance of
drug treatment helps to create the impression that psychiatric
conditions are easily treatable. This helps to justify coercion on
medical grounds thus avoiding the scrutiny that would be entailed in
legislation that was more transparently concerned with social control. I
have argued elsewhere that it is the medicalisation of psychiatric
legislation that has facilitated the expansion of coercion that is
represented by the measures proposed in the new Mental Health Bill
(Moncrieff, in press).
Foucault described psychiatry as "a moral tactic…
overlaid by the myths of positivism." The modern psychiatrist wields an
"authority he has borrowed from order, morality and the family" although
from the 19th century onwards he "no longer quite knew what
was the nature of the power he had inherited.." (Foucault, 1971,
quotations P 274 to 276). This is what makes the marketing of
psychiatric drugs into a force for social control and conformity.
Personal or social problems are defined as diseases and the authority of
psychiatry, backed by the financial muscle of the drug companies, is
used to enforce this view. In the process we are encouraged to radically
alter our view of ourselves and the world. We are encouraged to aspire
to narrow norms of behaviour and taught that anything else is not only
undesirable but unnatural or diseased. We are encouraged to think that
changes should be effected not by ourselves on our environment, but by
technology on ourselves.
Effects on psychiatric practice
Drugs so dominate psychiatric practice that
it is not easy to develop alternative forms of treatment, even though
some research suggests that patients with severe mental disorders may do
well without them (Mosher, 1999; Lehtinen et al, 2000). In the UK,
inpatient psychiatric units, in particular, have become more and more
focused around drug treatment in recent years, with little else of
therapeutic value on offer. One report found that 40% of inpatients had
no social or recreational activities available to them and that
occupational therapy and psychology services were very limited
(Sainsbury Centre for Mental Health, 1998). Family therapy and Cognitive
Behavioural Therapy have both been shown to be of value in the
treatment of psychosis but they are rarely available in ordinary
clinical practice in Britain.
Although there is increasing demand for counseling
services and psychotherapy for the treatment of less severe mental
disorders, this does not appear to represent a serious challenge to the
medicalisation of such problems achieved by the widespread prescription
of drugs. It appears to be rather another expression of an increasing
demand for medical services that is encouraged by the marketing of
drugs.
The pharmaceutical industry has supported the
emphasis on long-term prescribing for psychiatric disorders and may also
have encouraged the use of unnecessarily high doses of psychiatric
drugs. Recent studies purporting to show the benefits of long-term
treatment in a range of disorders including depression (Claxton et al,
2000), bulaemia (Romano et al, 2002) and obsessive compulsive disorder
(Koran et al, 2002) were all supported by the pharmaceutical industry.
Patients with chronic disorders often stabilise and many might benefit
from attempts to reduce or stop medication (Gilbert et al, 1995).
However, this can prove practically difficult in a culture that is so
dependent on drug treatment. In a recent book, Jay S Cohen (2001)
suggests that doses are tailored to make prescribing easier and inflate
efficacy findings; he cites the fact that the recommended doses of one
in five drugs is lowered years after the drugs are licensed. A review of
the evidence on dose ranges for antipsychotics suggested that
moderately low doses are preferable to the higher doses that are
commonly used (Bollini et al, 1994).
II EXPANDING MENTAL DISORDERS
Psychiatric diagnoses are based on behaviours and
mental experiences that are deemed to be abnormal or dysfunctional.
They are notoriously difficult to define consistently and even the
painstaking construction of standardised definitions, such as those
first produced in the Diagnostic and Statistical Manual (DSM) version
III, and subsequently revised in DSM IIIR and DSM IV, yield fairly poor
reliability statistics (for a review of reliability studies see Kirk
& Kutchins, 1999). Because there are no natural or physical
boundaries to the definition of abnormality in relation to behaviour and
mental experience, psychiatric disorders are particularly fluid and
what counts as disorder is highly dependent on prevalent social norms
and beliefs. Thus many commentators are concerned that the incorporation
of more and more forms of ordinary difficulties, such as shyness and
childhood behavioural problems under a psychiatric umbrella is an
example of the encroaching and inappropriate medicalisation of everyday
life (Moynihan et al, 2002; Double, 2002).
Examples of the expansion of psychiatric concepts include:
The promotion of Depression
The promotion of depression is not new to
psychiatry. In the 1950s, Merck, the company that had just launched the
antidepressant amitriptyline, bought up and distributed 50,000 copies of
a book, entitled "Recognising the Depressed Patient" by psychiatrist
Frank Ayd, which suggested that depression was much more common than
usually thought (Healy, 1997a). Then, from the late 1980s with the
introduction of a new generation of antidepressants called SSRIs,
interest in depression increased dramatically. The pharmaceutical
industry and the medical profession joined forces in campaigns such as
the Defeat Depression Campaign in the United Kingdom, which set out to
increase the numbers of patients diagnosed with depression and treated
with antidepressants in General Practice. In order to achieve this, the
campaign tried to convince General Practitioners of the high prevalence
of the condition and combat the general public’s resistance to taking
antidepressants. The campaign and associated literature claimed that
depression affects 5% of the general population at any one time but also
that up to a third of people might experience depression at some time
in their lives (Paykell & Priest, 1992). It was also suggested that
20% of General Practice attenders might have some symptoms of depression
and that around half of these might need treatment (Paykell &
Priest, 1992).
It is difficult to demonstrate that the increased
number of people taking antidepressants over the last decade has had any
objective benefits. Long-term disability due to depressive disorders
has been increasing over the same period (Moncrieff & Pommerleau,
2000). Although some authors, with extensive links to companies
producing antidepressants, have claimed to show an association between
increased use of antidepressants and lowered suicide rates (Hall et al,
2003), their own data has been shown to give the opposite results
(Moncrieff, 2003). Others have noted that suicide rates have not fallen
in line with increases in prescribing, and that rates of self harm have
been increasing (van Praag, 2002). It has been suggested that the drug
industry turned its attention to depression because of the
disintegration of the market for benzodiazepines after the discovery of
their addictive potential (Healy, 1999). Hence it seems that the
escalating rates of use of antidepressants may have more to do with
marketing imperatives than any benefits to mental health.
Recent interest in depressive disorders has focused
on the extent of problems in the developing world and in children. A
recent World Health Organisation (WHO) report suggests that 10% of women
worldwide suffer from a depressive episode in every 12 month period
(WHO, 2001). The American National Institute for Mental Health’s new
mood strategy prioritises the detection and treatment of depression in
children (Costello et al, 2002). These moves potentially pave the way
for massive expansion of antidepressant markets in the developing world
and among children in the developed world. There are indeed already
indications of increasing use of antidepressants, as well as other
drugs, among children, including the very young (Zito et al, 2000).
The "Creation" of Social phobia
In 1998, the pharmaceutical giant SmithKline
French applied to the FDA in the United States for a license to market
its antidepressant, Paxil (paroxetine) as a treatment for Social Anxiety
Disorder, or social phobia. Although there is a description of these
conditions in the DSM and the WHO diagnostic classification systems,
they were not previously regarded as amenable to drug treatments nor
considered to be a significant public health problem. The pharmaceutical
companies involved would argue that they were trying to raise awareness
of a then little known and little treated, but potentially
debilitating, disorder. In contrast, it has been suggested that the
SmithKlineFrench campaign was prompted by the need to find a wider
market than the market for depression, which was then dominated by two
other antidepressants, Prozac and Zoloft (Mother Jones, 2002).
An investigation by Mother Jones magazine relates how
in early 1999 Cohn & Wolfe, a PR firm working for SmithKline,
started a campaign to persuade people that social anxiety disorder was a
serious and common disorder. Poster campaigns with slogans such as
"Imagine being allergic to people" were conducted and video and radio
news releases were created. Journalists were given a press pack stating
that up to 13% of the population suffer from Social Anixety Disorder and
that it is the third most common mental disorder after depression and
alcoholism (Mother Jones, 2002). Cohn & Wolf also supplied
journalists with eloquent patients and two Professors of psychiatry,
both of whom worked as consultants to drug companies, including
SmithKline, were featured on numerous television programmes. By May
1999, when the license for Paxil for Social Anxiety Disorder was
approved by the FDA, there were hundreds of stories about the condition
in the American media. A few months later, SmithKline launched
advertisements promoting the use of Paxil for Social Anxiety Disorder,
and by the end of the year it had become the United States second best
selling SSRI with sales on a par with Prozac.
In Australia, Roche, makers of another new
antidepressant moclobomide, launched a similar disease awareness
campaign about social anxiety disorder, or social phobia. Moynihan et al
(2002) have described how the promotion campaign seemed designed to
"change the common perception of shyness from a personal difficulty to a
psychiatric condition." A senior Roche official recently admitted that
company promotion had exaggerated the prevalence of the condition (BMJ
News, 13th April, 2002).
Pharmaceutical Marketing held up social phobia as an
example of the importance of shaping public and medical opinion about
disease concepts: "You may need to reinforce the actual existence of a
disease and/or the value of treating it" (Pharmaceutical Marketing,
2002)
Pathologising childhood and the marketing of stimulants
The pharmaceutical industry has helped to
promote the idea of the "hyperactive child" since Ritalin, manufactured
by Ciba pharmaceuticals (who merged with Sandoz to become Novartis), was
approved for use in children in the 1950s. In an early study Schrag
& Divoky (1975) catalogued Ciba’s aggressive promotional tactics in
the United States, including presentations to Parent Teacher
Associations and other parent groups, at a time when direct to consumer
advertising was illegal in the US.
There is currently an epidemic of stimulant use among
school age and younger children. One survey in the United States in
1995 found that 30 to 40% of school children were taking stimulants
(Runnheim, 1996). Prescription rates in the United Kingdom are also
rising rapidly. Numbers of prescriptions increased by around 30% in 3
years between 1998 and 2001, and the cost of these prescriptions more
than doubled (Department of Health, 2002). Although common stimulants
are relatively cheap drugs, drug companies have recently been producing
new and expensive preparations. This has fuelled huge growth in costs of
stimulant prescribing. Stimulants showed the largest increase in
financial sales, at 51%, between 2000 and 2001 of all classes of
prescription drugs in the US (NIHCM, 2002).
The conditions for which these drugs are
prescribed are now called Attention Deficit Hyperactivity Disorder
(ADHD) or Attention Deficit Disorder (ADD). Despite the insistence of
the advocates of a neurobiological approach in a recent "International
Consensus Statement" (Barkley et al, 2002), the validity of the disorder
is far from established. Critics have catalogued the wide variations in
diagnostic practice and how definitions of the disorder have been
widened to include more and more children over the last couple of
decades (Timimi, 2002). Even the American National Institute of Health
concluded that there was no evidence that ADHD was a biological brain
disorder (National Institute of Health, 1998). Although trials
demonstrate that stimulants have short term effects on concentration and
attention, a recent Cochrane review found that there was little longer
term research and questioned the overall value of using stimulant
medication (Schachter et al, 2001). The publication of the International
Consensus Statement (Barkley et al, 2002) is an explicit attempt to cut
short debate on these issues and it is therefore of great concern that
the authors were not required to divulge potential conflicts of
interests.
The pharmaceutical companies have been actively
involved in the promotional campaigns that have brought about this
situation. In the United States they have achieved this partly in
co-operation with CHADD (Children and Adults with Attention Deficit
Disorder), which is predominantly a parent’s organisation, set up in
1987. It is highly active in promoting biological views of the nature of
ADD, and acceptance of drug treatment. Material produced by Novartis
and CHADD promotes the idea that ADD is an established "neurobiological
disability" and that stimulants work by "correcting for a neurochemical
imbalance" (quoted in Breggin, 2001, chap 14, P225). CHADD also runs
national "information" campaigns, and is currently organising a campaign
to reach sections of the community that are currently "under-served" in
terms of diagnosis and treatment of ADD (www.CHADD.org). It is also
engaged in vigorously opposing any moves to restrict the prescribing of
stimulants to children. In addition, it produces publications, supports
research, lobbies national and local government and holds annual
conventions and conferences. It currently receives around 20% of its
funding from pharmaceutical companies (www.CHADD.org).
The expansion of psychosis
The new or atypical antipsychotics have
proved to be very profitable for the drug companies that produce them.
In 2001 they were ranked 13th among the top selling drugs in
the United States and their use had increased by 12.5% in one year
(NIHCM, 2001). Their popularity has been unaffected by concerns about
the validity of their research base (Geddes et al, 2000, see above).
Shortly after the introduction of the atypicals,
various concepts about the early treatment and prevention of psychosis
started to become fashionable, which are likely to result in increased
rates of prescribing of these drugs. Early intervention is usually taken
to mean early treatment for someone who has developed full-blown
psychotic symptoms. Trials of preventive treatment involve "high risk"
individuals, usually young people, who are defined by having a family
history of schizophrenia, or having "attenuated" psychotic symptoms.
There is obviously the potential for considerable overlap between the
concepts of early intervention and prophylactic treatment, since they
depend on judgements about what constitute full-blown psychotic symptoms
and what do not. Both concepts suggest that the boundaries of when to
initiate treatment for psychosis should be extended and should not
depend on making a definitive diagnosis, or on the current degree of
impairment of functioning. Both concepts are popular and fashionable,
but contentious, and the strength of evidence on which they are based is
disputed. Critics have argued that such programmes expose many people
to the adverse effects of drugs who would never develop psychosis or
schizophrenia, and that non drug treatments are neglected (Verdoux,
2002; Bentall & Morrison, 2002).
The drug companies, notably the makers of new
antipsychotics, have provided funding for conferences and journal
supplements on Early Intervention and preventive treatment, and are also
funding, or part funding drug trials involving treatment of young
people judged to be at "high risk." The only completed and published
randomised drug trial to date was small and not conducted double blind.
Results showed small preventive effects that were not sustained over the
follow up period. In addition, only 27% of the sample went on to
develop a full blown psychosis and only 12% were diagnosed as having
schizophrenia one year later (McGorry et al, 2002).
Colonising and inventing other conditions
I have illustrated only a selection of the
expansion of psychiatric drug markets over the last decade or so. The
marketing of drugs for other types of anxiety disorders such as panic
disorder, generalised anxiety disorder and obsessive compulsive disorder
and of drugs for alcohol problems, drug misuse, buleamia, post
traumatic stress disorder, menstrual dysphoric disorder, compulsive
shopping and intermittent explosive personality disorder, have helped to
convince more and more people that they have a mental disorder that
needs treatment. In the process, a market for drug treatments has been
created in areas where they were formerly not frequently used. The
common factor is the identification of a diagnosis or concept that is
constituted by behaviours and emotions that have a substantial overlap
with normal experience. The condition is then inherently expandable,
which allows the drug companies and their advocates to claim that they
abhor the inappropriate over-prescribing of their drugs (Barrett, 2002),
safe in the knowledge that this will almost certainly occur anyway.
III NEGLECT OF ADVERSE EFFECTS
Adverse effects of drugs represent a major public
health problem with recent estimates indicating that 1.5 million
Americans are hospitalised and 100,000 die each year, making drug
related adverse effects one of the leading causes of death (Lazarou
& Pomeranz, 1998). 51% of drugs of approved drugs have serious
adverse effects that are not detected prior to approval (US General
Accounting Office, 1990). It has been suggested that the system for
monitoring adverse effects in the United States and elsewhere is wholly
inadequate (Moore et al, 1998; Woods, 1999). For example, neither the
Food and Drug Administration in America, nor the Medicines Control
Agency in Britain, collect routine data on the prevalence and
consequences of adverse effects.
It has long been known that patients with severe
mental disorders have much reduced life expectancy, but there has been
little attention until recently to the possibility that some of this
risk may be associated with drug treatment. A recent study found that
death rates in people on long-term treatment with commonly used
antipsychotics were three to six times higher than patients taking
medication for other non fatal medical conditions (Henessy et al, 2002).
Lifestyle factors such as high rates of smoking are likely to account
for a part of these high death rates, but the study appeared to confirm
other evidence that suggests that antipsychotics can induce fatal
cardiac arrythmias (Zarate & Patel, 2001). This propensity has been
known about for many years, but drugs such as droperidol and
thioridazine, which had been in widespread use for decades, have only
recently been withdrawn due to their cardiotoxicity. There is also
growing concern about the side effects of the newer atypical
antipsychotics, especially their tendency to cause severe obesity and
diabetes (Kero et al, 2002) and they have also been associated with
adverse cardiac events (Hennessy et al, 2002).
Some companies have been accused of minimising the
adverse effects of their products. Eminent psychopharmacologists claimed
that drug companies attempted to impede publication of the adverse
effects of Halcion and sulpiride (Ian Oswald and Pierre Simon
interviewed in Healy, 2000). Bodenheimer (2000) also describes two cases
in which companies have attempted to prevent the publication of papers
about adverse effects. In the UK, solicitors for the Seroxat Users Group
are currently considering whether to launch a lawsuit against
GlaxoSmithKline for failing to warn patients about the discontinuation
reactions experienced after stopping their best selling drug Seroxat
(paroxetine).
CRITICISM OF THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY
Several sections of the general media have
recently featured critical discussions of the relationship between
medicine and the pharmaceutical industry, including British newspapers
the Guardian and Scottish Herald and American magazines USA Today,
Public Citizen and Mother Jones. Criticism has also come from major
academic medical publications such as the New England Journal of
Medicine (NEJM), the Journal of the American Medical Association (JAMA),
the Lancet and the British Medical Journal (BMJ). The NEJM was so
concerned about the extent of the influence of the industry that it
published an editorial entitled "Is academic medicine for sale?"
(Angell, 2000).
Certain patient advocacy groups have taken a stand
against the sponsorship of psychiatry. In July 2001, the user group Mad
Pride organised a demonstration outside the annual Royal College of
Psychiatrists conference in London about the level of commercial
sponsorship underpinning the meeting. They were joined by members of the
Critical Psychiatry Network, a group of UK based psychiatrists also
concerned about the relationship between psychiatry and the drug
industry.
Other web-based organisations have emerged to oppose
corrupt marketing practices and their effects on medicine, including
Social Audit in the United Kingdom (www.socialaudit.org.uk), No Free
Lunch (www.nofreelunch.org)
and Healthy Skepticism (www.healthyskepticism.org). No Free Lunch urges
doctors to refuse drug company gifts and hospitality by taking a pledge.
Healthy Skepticism is currently campaigning to stop direct to consumer
advertising in New Zealand, and Social Audit is arguing against the
relaxation of legislation preventing direct to consumer advertising in
Europe. Consumer organisations including Health Which in the UK and
Public Citizen in the US are also critical of the pharmaceutical
industry’s power and influence.
WHAT SHOULD PSYCHIATRISTS DO?
The current situation seems to many outsiders and
some insiders to indicate that the pharmaceutical industry has a
substantial influence on the theory and practice of psychiatry. It also
appears that there may be a serious conflict for psychiatrists between
satisfying the needs of patients and the wider community, and serving
the interests of the corporations. Political pressure is rightly
demanding that all institutions become more accountable and more
transparent. In response the Royal College of Psychiatrists is
initiating a review of its relationship with the pharmaceutical
industry. It is drafting guidelines on the relationship between the
College and the industry and on relationships between individuals and
the industry (Paul Jessop, personal communication, March 2003).
I suggest that there are some further steps that should be taken to improve the integrity of psychiatry in the United Kingdom.
- The Royal College of Psychiatrists should
publish in its accounts the exact amount of funding it receives each
year from different pharmaceutical corporations.
- The Royal College of Psychiatrists should
create and publish a register of member’s interests that should be made
publicly available.
- The Royal College should initiate a
discussion among its members about the ethics of receiving drug company
hospitality and discussions should also be initiated at a local level.
- Psychiatric institutions, including the Royal College, should stop accepting commercial sponsorship for educational events
- Full disclosure of interests should be
required by all psychiatric journals and for conference presentations.
Torrey (2002) provides an example of the latter: "prominently displayed
next to the speakers lectern should be a sign reading ‘For this talk Dr
Smith is being paid $3,500, business class air fare and four star
accommodation by Eli Lilly and Company.’"
- Conflicting interests of authors of clinical
guidelines should be reported and guideline committees should develop
policies for managing these situations.
- Guidelines should be drawn up for research
personnel, which should set limits on fees received from companies and
should prohibit researchers from holding stock in companies whose drugs
they are investigating (Torrey, 2002).
- Funding bodies should support research into treatment approaches that genuinely represent alternatives to a reliance on drugs.
CONCLUSIONS
As a society we are consuming more medicinal
drugs than ever and a large proportion of these are for psychological
conditions and complaints. This is making a major contribution to
spiraling health costs and takes money away from other health services.
Psychiatric practice is now firmly centered around drug treatment, and
millions of other people, who have no contact with a psychiatrist, are
receiving psychotropic drugs in General Practice. In recent years we
have been encouraged to view more and more problems that were previously
considered to be normal and manageable parts of the human condition as
mental diseases that require treatment. The promotion of the idea of
technical and professional solutions, the medical colonisation of
everyday life, has profound consequences. At the individual level it
seems likely to reduce personal coping strategies, to "gnaw away at our
self confidence" (Payer, 1992). This is true in the area of mental
health more than any other, since mental health involves our view of our
own capabilities; the nature of our very selves. At the social level,
the medicalisation of various problems obscures the effects of social
changes that have taken place in the UK over the last couple of decades.
For example, the retraction of the welfare state, increasing working
hours, job insecurity and the dismantling of pension schemes have made
life more difficult and more uncertain for many ordinary people. A
society obsessed with its own navel is unlikely to be able to mount an
effective challenge to these trends.
Psychiatry and the pharmaceutical industry make a
formidable combination. Modern psychiatry derives its legitimacy from
the notion that mental disorders are equivalent to medical diseases and
it is this that justifies the coercion of psychiatric patients. Drug
treatments that are aimed at specific diagnoses help to endorse this
view, and the industry has the financial capacity to ensure that this
view becomes accepted and respectable. In turn, the authority of
psychiatry enables it to define what is considered as mental disorder
and what is appropriate treatment, thus creating markets and
opportunities for the pharmaceutical industry.
The influence of the pharmaceutical industry over
political processes and research is an example of what George Monbiot
has termed the corporate take-over of Britain (Monbiot, 2000). The power
of the pharmaceutical industry is particularly worrying, because the
commercial incentive to promote disease and sell pills potentially
changes our view of what it is to be human. Fortunately, there are signs
of unease within the medical community about the degree and
consequences of drug company influence. It is time for the psychiatric
profession to reflect on its relationship with the pharmaceutical
industry and attempt to reclaim its integrity.
ACKNOWLEDGEMENTS
I would like to thank Professor Robin Murray and
Dr Peter Mansfield for their helpful comments on a previous draft of
this paper, Madeline Moncrieff for legal advice and Michelle Blythe for
her help in locating material.
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