All about PSY DREAMPsychiatric
Drug Registration, Evaluation & All-inclusive Monitoring
key note lecture at the conference "Inclusion and Mental Health in the New
Europe," run by the European Network for Mental Health Service Evaluation,
London, September 35, 2004
SUMMARY: Aims In this article the authorboard-member
of the European Network of (ex-) Users and Survivors of Psychiatry
(ENUSP)explains, what is needed to guarantee a minimal level
of involvement of users and survivors of psychiatry into issues
relating to psychiatric drugs. Methods He reflects
demands of their organisations, and compares these demands with
the current involvement level. Considering the concrete circumstances
in psychiatry, he reflects the risks and dangers of the administered
drugsespecially the widely used neurolepticsfor example
enhanced breast cancer risk in women, suicidal effects, receptor
changes, tardive dyskinesia and other toxic reactions. Results
Considering the unique situation of psychiatric patients
to receive treatment in general without informed consent and in
a violent way or through bullying and threat, he argues for to
provide their involvement in all aspects of psychiatric drug issuesespecially
registration and monitoring, for example by their involvement
in creating and running a suicide register. And he argues for
involvement in ethics committees, licensing processes and providing
guidelines and decision making about effectiveness and reimbursement
of costs. Conclusions As first steps towards these
aims he proposes independent and user-controlled research, independent
and user-controlled education and independent and user-controlled
information about the effects of psychiatric drugs.
of Interest: the Author did not receive any grants and financial support received
for the study; any forms of financing (included pharmaceutical company support
and any honoraria for consultancies or interventions in the last two years); any
other involvements that might be considered a conflict of interest in connection
with the submitted article.
KEY WORDS: Psychiatric drugs, involvement of
users, registration, evaluation, monitoring.
paper gives an overview of how far the movement of (ex-) users and survivors (1)
of psychiatry in Europe has to go to achieve the aim of full involvement in two
key aspects of psychiatric drug use; the registration of drugs and monitoring
of drug effects. In general the European Network for Mental Health Service Evaluation
(ENMESH) has a quite optimistic view on user involvement:
and consumer involvement is arguably the most exciting recent development in mental
health services across Europe. The inclusion of service users as equal partners
in all aspects of delivery and development is perhaps the greatest challenge facing
services today." (ENMESH, 2004, p. 6)
of ENUSP on user involvement and psychiatric drugs
The European Network
of (ex-) Users and Survivors of Psychiatry (ENUSP) was asked in 1988 to write
a commentary on the World Health Organization's (WHO) Quality Assurance in
Mental Health Care, DraftHuman rights of people with mental disorders
(World Health Organization, 1997). ENUSP stated that
should be bodies including (ex-) users and survivors of psychiatry specifically
charged, at national levels, with monitoring how human rights are respected for
people with, or are said to have, mental disorders. The task of these bodies should
include the registration of new treatment measures and decisions of ethics' committees
in research fields." (Lehmann, 1999, p. 6)
For future ENUSP
tasks, one of the key points was decided, at its congress "Into the Next
MillenniumMoving Forward to Our Own Future" 1999 in Luxembourg:
should demand that the drug companies are forced by law to pay reparations. These
reparations should be held in a fund administered by (ex-) users and survivors
of psychiatry to research, develop, publicise and run alternatives to psychiatry."
In the same year ENUSP agreed to a Consensus Paper,
which was adopted at the Joint World Health Organization / European Commission
Meeting in Brussels 1999. "Developing innovative and comprehensive, explicit
mental health policies in consultation with all stakeholders, including users"
and "Highlighting research and development, establishing mental health information
and monitoring" (World Health Organization, 1999, p. 9) were principles,
which have been welcomed by ENUSP.
User involvement in psychiatric
drugs issues nowadays
From this principle of involvement in decision
making processes concerning psychiatric drugs issues the reality differs. Currently
the main involvement of users of psychiatry is opening the mouth and swallowing
administered drugs or presenting the buttocks to receive an injection. There is
no involvement in any form of decision making, neither in licensing psychiatric
drugs or monitoring, nor in individual decision making. Complete and understandable
information, the basis for meaningful involvement, does not exist. Often psychiatric
drugs are administered in a violent way or through bullying and threat.
is no information at the starting point of the drug administration, nor during
the course of treatment in a psychiatric clinic, nor at that point when people
are discharged from psychiatric wards and long-term treatment starts. Psychiatric
and medical publications unanimously support this position. Researchers from psychosocial
organisations like the mental health charity Mind (England & Wales) came to
similar conclusions; Margaret Pedler from Mind suggested that 71% of patients
receiving SSRIs, were not informed about so-called side-effects, nor were 77%
of patients who received neuroleptics (Pedler, 1999). The quality of the information
given is unknown.
Ten years ago the Bundesverband Psychiatrie-Erfahrener
(the German Association of Users and Survivors of Psychiatry) participated in
a study on quality of psychiatric care. Its members were asked: "Have you
been informed about risks and so-called side-effects completely and comprehensibly?"
In theabout105 returned answer-sheets not in one case there was a
positive answer (Peeck et al., 1995).
German psychiatrist Hanfried
Helmchen philosophized about the appropriate time for information about irreversible
risks in neuroleptics. With reference to the ideas of his colleagues he suggested
that information should be given either one year after starting the drug or when
the first signs of tardive dyskinesia appear, because:
percentage of refusal would probably be very high, if all acute schizophrenic
patients were to be informed about this risk before the start of a necessary neuroleptic
treatment." (Helmchen, 1981, p. 83)
This psychiatrist was
not unrepresentative of his psychiatric colleagues; he was the President of the
German Association of Psychiatrists and Neurologists at the time.
and survivor-controlled information
Users and survivors of psychiatry
started to publish independent information about risks of psychiatric treatment.
Leonard Roy Frank with "The History of Shock Treatment" set the example
in 1978 (Frank, 1981). The author of this article, Peter Lehmann, started independent
publications about psychiatric drugs in 1981 with his article "What you always
wanted to know about psychiatric drugs" (Lehmann, 1981). In the USA David
Oaks, now working for MindFreedom, followed with his article "Thorazine,
Mellaril, Haldol, Prolixin: bizarre facts about neuroleptics" (Oaks, 1982/83).
Finally the author set up his own publishing house to publish different books
in German and (since 2004) in English about: the effects of psychiatric drugs
on the metabolism and the mental, psychic and organ system (Lehmann, 1986; 1996a;
1996b) inclusive alternatives (Kempker & Lehmann, 1993) and successful withdrawal
from neuroleptics, antidepressants, lithium, carbamazepine and tranquilizers (Lehmann,
To enable users of psychiatric drugs and their supporters to
find information independently, the author provides online information
in English, German, Italian and French about helpful sources:
The Berlin organisation "In Any Case" provides training
& research from the user/survivor perspective in psychiatric
drug matters, both in English and German for professionals and
psychosocial organisations also publish information about psychiatric drug so-called
side effects. An example is Mind's report on the yellow card project which showed
how unpleasant, disabling and, in some cases, life-threatening the so-called side
effects of psychiatric drugs can be (Cobb et al., 2001). In 2004 the Scottish
Association for Mental Health (SAMH) published with "All you need to know?"
a user-orientated survey of psychiatric drugs based on a survey of people's experience
of psychiatric drugs. Because such organisations are not user-controlled, and
many members are providers of mental health services, there is a tendency to comply
with the dominant psychiatric view that medication is basically safe. This compliance
is found in both those patients, who contribute to such reviews or in the people
who edit them. SAMH for example warns:
"Don't be put off seeking
help because of some of the comments in their reports. Very many people who returned
forms said they found medication helpful." (Bradstreet & Norris, 2004,
A neutral person would add: "Don't lose caution because
other people report positively. We may have a tendency to be compliant patients,
but nobody knows beforehand how psychiatric drugs work in your individual and
Reports, if critical, are helpful, and they might, as
the law requires, give a part or all the information psychiatrists deny users.
Online information reaches only a privileged number of service users. Few psychiatric
institutions have service user access to the internet (a notable exception is
Shelton Hospital in Shropshire, England). Mind-altering effects ("Zombie
syndrome") prevent people giving reports on the bad effects of psychiatric
drugs or understanding those reports. Reports on risks and damages always come
to late, when the damage is already done, when severe and irreversible damage
has developed, when dependency has developed, or when people are simply already
Complexity of medical problems
user and survivors of psychiatry could not understand medical problems because
those problems are complex. They cannot be noted in individual anecdotal reports;
they should be addressed in governmental and administrative monitoring bodies.
Four examples of neuroleptic toxicity shall illustrate the difficulty.
and tolerance building is a dark area not least because psychiatrists strictly
deny its existence in public. In their own magazines they speak differently, as
the example of the German psychiatrists Rudolf Degkwitz and Otto Luxenburger shows,
"We now know that it is extremely difficult,
if not impossible, for many of the chronic patients to stop neuroleptics because
of the unbearable withdrawal-symptoms." (Degkwitz & Luxenburger, 1965,
Ever since the emergence of psychiatric drugs, many people
who have taken prescriptions have made their own decision to quit. One can only
speculate how many people have attempted to quit after having been exposed to
the idea in an uninformed way only to experience a "relapse" and eventually
another prolonged administration of the drugs. I think it is safe to say that
a great number of attempts to quit would have been more successful if those wishing
to quit and those around them had been better informed as to the potential problems
that may arise as well as of means for preventing the often-prophesied relapse.
Psychiatrists have reported the following psychological withdrawal symptoms: a
depressed mood, fear, a desire to run away, and fits of crying. Because a reduced
dosage may result in motor disturbances and emotional pain caused by the neuroleptics
becoming more pronounced and/or particularly intense (due to the fact that the
emotional numbing of the drugs has subsided), a temporarybut nonetheless
seriousrisk of suicide may arise during withdrawal. How often are these
withdrawal-problems misdiagnosed as relapse into psychoses?
destructiveness, aggression, irritability, and excitability may develop into withdrawal
psychoses and delirious states. Fritz Reimer, like Degkwitz a former President
of the German Association for Psychiatry and Neurology, concluded the following
concerning the possibility of post- withdrawal delirium that may last several
"The ultimate factor in the delirium syndrome is certain
to be the psychoactive pharmaceuticals. On the surface, it appears to compare
to the withdrawal delirium of the alcoholic." (Reimer, 1965, pp. 446f.)
withdrawal symptoms that may occur include anorexia (or a lesser loss of appetite),
binging, nausea, vomiting, gastritis, diarrhea, stomach ache, colic, pronounced
nasal discharge, sebaceous gland discharge, hot flashes, freezing, pronounced
sweating, cardiovascular (i.e. heart and circulatory system) problems such as
a racing heartbeat, dizziness and physical collapse. The dangers that proceed
from the habituation of a vegetative state and a physical dependence on neuroleptics
have been shown in a rabbit study by Helma Sommer and Jochen Quandt at the Psychiatric
Clinic in Bernburg/ Saale. Their observations were based on noted metabolic changes
induced by chlorpromazine that caused a circulatory collapse after withdrawal
from the neuroleptic, despite the fact that metabolism was in fact returning to
normal. For six months, Sommer and Quandt administered neuroleptics to 20 rabbits.
The four animals that had received the highest dosage (16.7 mg/kg) died after
a brief fit of cramping:
"At a dosage of 13.3 mg/kg of chlorpromazine,
abrupt withdrawal led to a sudden death within 14 days, probably due to irreversibly
blocked metabolic processes that stopped functioning (similar observations in
human beings have been published in which death followed a brief stage of cramping)."
(Sommer & Quandt, 1970, p. 487)
In 1997 Urban Ungerstedt und
Tomas Ljungberg at the Karolinska Institute in Stockholm published results of
studies in which rats were administered the conventional neuroleptic haloperidol
and as a comparison the "atypical" clozapine. They believe that "atypical"
neuroleptics modify subtypes of specific dopamine-receptors, produce their supersensitivity
and contribute to the risk of new, increasing, or chronically powerful psychoses
of organic origin, which can be understood as "counterpart to tardive dyskinesia"
(Ungerstedt & Ljungberg, 1977, p. 199). Since then, medical journals have
steadily published findings on supersensitivity, rebound and withdrawal psychoses
(see Lehmann, 2004, pp. 32ff.).
The frequent damage caused by typical neuroleptics
like haloperidol arises from changes in dopamine-D2-metabolism,
observable as motor disturbances; the usual damage caused by "atypical"
neuroleptics like clozapine, sertindole or quetiapine goes in the direction of
changing the metabolism of special subtypes of dopamine-receptors, dopamine-D1
and -D4, seen as producing or increasing mid- and long-term psychotic
syndromes of organic origin. Frank Tornatore and his colleagues at the University
of Southern California School of Pharmacy in Los Angeles warned of the development
of supersensitivity psychoses:
"There is a worsening of the
psychosis (delusions, hallucinations, suspiciousness) induced by long-term use
of neuroleptic drugs. Typically, those who develop supersensitivity psychosis
respond well initially to low or moderate doses of antipsychotics, but with time
seem to require larger doses after each relapse and ultimately megadoses to control
symptoms." (Tornatore et al., 1987, p. 44)
Supersensitivity should be understood as the result of an increased
tolerance to the drugs, as they point out in an additional citation
in the German translation of the book four years later: "Thus,
a tolerance to the antipsychotic effect seems to develop."
(Tornatore et al., 1991, p. 53)
neuroleptics in general are announced as less harmful drugs. People will not receive
necessary information to come to an informed decision when these drugs are offered.
Gerhard Ebner, Chairman of the Swiss Association of psychiatric chief doctors
and member of the Advisory Board of Janssen Cilag for the introduction of Risperdal
"We do not have less side-effects, but other
ones. They can also be very drastic, even when the patients do not perceive them
directly. For that reason the patients can be motivated to take the antipsychotics
more easily, the excruciating dyskinesias / extrapyramidal side-effects do not
occur or not so heavy." (Ebner, 2003, p. 30)
Breast cancer risk is another example. Uriel Halbreich and
colleagues from the Gynaecological Department of the State University of New York
in Buffalo compared mammograms of 275 female patients over 40 treated between
1988 and 1993 at the Buffalo Psychiatric Center, with mammograms from 928 patients
from the Erie County Medical Center, a General Hospital. In 1996 they reported
in the "American Journal of Psychiatry," that the risk of breast cancer
in female psychiatric patients was 3.5 times higher than in general patients,
and 9.5 times higher than the average. The main and only explanation they had
was the carcinogenic effect of raised levels of the hormone prolactin. Raised
prolactin levels are common even in small doses of psychiatric drugs and suspected
to be responsible for one third of female breast cancers. They conclude:
confirmed, the suspected higher incidence of breast cancer among the psychiatric
patients might be due to medications and further underscores the need for screening
mammograms for breast cancer in these patients." (Halbreich et al., 1996,
Raised suicide rates since
the introduction of neuroleptics are well-knownfor psychiatrists. In single
cases these rates are explained by reference to symptom-changes. In the American
Journal of Psychiatry, which in general is not read by users and survivors
of psychiatry, the American psychiatrist Frank J. Ayd says openly:
is now general agreement that mild to severe depressions that may lead to suicide
may happen during treatment with any depot neuroleptic, just as they may occur
during treatment with any oral neuroleptic." (Ayd, 1975, p. 497)
German colleague Peter Müller explained in his specialists's book:
syndromes after the remission of the psychoses and under treatment with psychiatric
drugs are not rare, but occur on about two thirds of the patients, and sometimes
even more frequently. (…) Without treatment with psychiatric drugs, depressive
syndromes after a complete remission are only found in exceptional cases."
(Müller, 1981, p. 72)
Otto Benkert and Hanns Hippius (1980),
two other German psychiatrists, answered the question, whether suicidality perhaps
could be caused by an excessive dosage:
states of excitement and delirium under the influence of drugs generally occur
during doses prescribed by the treating physician." (Benkert & Hippius,
1980, p. 258)
"Atypical" psychiatric drugs have also
suicidal effects, as the report of Ursula Fröhlich, living in Austria, shows:
I began taking Leponex (clozapine), I do not want sex anymore, did not feel like
moving and had no joy in life. A life without joy is, however, worse than death.
All that remained with me is watching TV, where I have watched others living for
seven years. I am still alive biologically, but my senses are long since dead,
everything that I former enjoyed I am not able to do anymore. In a way, my life
does not exist anymore, I feel so empty and unimportant. In the mornings, the
feeling is the worst. Every day I intend to start a healthy life the following
day, to throw away the drugs, to drink many vitamins and fruit juices and to start
with a daily fitness routine. The psychiatric drugs cause a feeling as if it was
possible for me to start with a completely different, a new life the following
day. But when I wake up in the morning I feel like smashed, and I never come out
of bed before 9 o'clock, my depressions are so extreme that I think of suicide
every day. (Fröhlich, quoted from Lehmann, 1996a, p. 70ff.)
There are more severe effects which might occur,
but risks like receptor changes, pancreatitis, agranulocytosis, malignant hyperthermia,
malignant neuroleptic syndrome etc. are never spoken of, so no early warning signs
of iatrogenesis are explained. There is much information available on risks of
psychiatric drugs. This is already well known to the pharmaceutical industry and
in medical science; to gather this again on the basis of reports of the user experience
is not the way to implement fair user-involvement.
Sometimes drug companies
simply hide negative drug effects. One example appeared in the British newspaper
The Independent on August 27, 2004. Writing about problems with the antidepressant
paroxetine (marketed as Allenopar, Aropax, Aroxat, Aroxetin, Casbol, Daparox,
Deroxat, Ennos, Euplix, Frosinor, Motivan, Oxet, Oxetine, ParoLich, Paroxat, paroxedura,
Paroxetin, Paxil, Paxtine, Sereupin, Seroxat or Tagonis) the journalist claims:
Anglo-American drugs giant (GlaxoSmithKline) has agreed to pay $2.5m (£1.4m) in
settlement of a court case brought by Mr Spitzer, who claimed GSK had suppressed
data suggesting its anti-depressant drug Paxil (called Seroxat in the UK) could
cause suicidal tendencies when prescribed to children ... had published only one
of five trials on Paxil ... effectively suppressing results that did not favour
the drug." (Grimford, 2004)
Officially reported unwanted effects
of psychiatric drugs might be only the tip of an iceberg. Sometimes not even proven
information about deadly effects are considered a problem for governmental bodies,
as the example of Richard Brook, chief executive of Mind, shows. Brook was representative
for Mind in the Medicines and Healthcare products Regulatory Agency (MHRA), an
expert group set up by the UK's Committee on Safety of Medicines to review the
safety of drugs. Brook had to face the nonchalance of MHRA over years referring
to suicidal effects of paroxetine in young patient. When he broke the silence
about the lack of initiative from the governmental body and made the scandal public,
the consequence was heavy criticism by the government.
There is clear-cut
governmental nonchalance, general disinformation or denial of information, harassment
and discrimination of people with psychiatric diagnoses in all parts of society,
including medical and mental health institutions (ENUSP, 2003a; 2003b). Facing
the fact, that people with psychiatric diagnoses are the only part of society
that has to face the danger of administration of drugs against by force, wouldn't
it be appropriate and necessary to ensure a minimum of user-involvement? At the
very least this should enable their organizations to be part of decision-making
about licensing of psychiatric drugs and part of monitoring bodies.
is any form of user-involvement in gathering and judging reports about psychiatric
drugs? How can they trust that their interest is meaningfully considered? Until
now, there has not been an opportunity for users or survivors of psychiatric drugs
to report bad effects to governmental bodies or manufacturers of psychiatric drugs.
The only systematic opportunity to report the negative effects has been given
to doctors and psychiatriststhe ones who often treat by force, deny information
and act on a non-egalitarian basis.
involvement in drug issues would require the involvement in licensing processes
in order to participate in decision-making about the granting and withdrawal of
licenses. This involvement could start with involvement in ethics' committees
and be followed by involvement in clinical studies on psychiatric drugs in the
form of involvement in the assessment of studies on new psychiatric drugs. This
might be directly or via trusted experts and end with recommendations to the governmental
Committee on the Safety of Medicines.
Involvement in the key aspects of
psychiatric drug use; the registration and monitoring of psychiatric drugs (PSY
DREAM; Psychiatric Drug Registration, Evaluation & All-inclusive Monitoring)
would deliver involvement in discussion and decision about guidelines and reimbursement
of costs through health insurance institutions (the UK equivalent might be seen
as the National Institute for Clinical Excellence). Compared to other medical
patients, a specific involvement of organisations of users and survivors of psychiatry
is required. This is due to the current discrimination, the current misinformation
and because of the ongoing and developing forced treatment; even outside madhouses
Meaningful involvement in PSY DREAM (Psychiatric Drug Registration,
Evaluation & All-inclusive Monitoring) would require:
& access to information
the chance to invite single users/survivors
of psychiatry to give direct information
the possibility to order
consulting specialists selected by survivors
representation of legitimate representatives of autonomous organisations of users
and survivors of psychiatry (i.e. independent from drug company economical influence,
and not replaced by parents' organisations: after all psychiatrists never are
represented by their parents)
at least double representation on
the users/survivors side
the requirement to publish and reveal
economic equality (for example, self employed persons
who give up paid work to attend PSY DREAM meetings need fees for attending those
combination of national and international aspects
specific form of monitoring psychiatric drugs: the suicide register
A specific form of monitoring psychiatric drugs is the suicide
register, as demanded some years ago by ENUSP and the German Association
of Users and Survivors of Psychiatry. Suicide is the primary cause
of death in people with the diagnosis "schizophrenia,",
and neuroleptics with their proven suicide risks are the main
treatment for people with the mentioned diagnosis (Müller,
1981, p. 1f.). Such a suicide register could enable means for
discovering the connection between suicidality and neuroleptics,
antidepressants, electroshocks, and other forms of psychiatric
compulsion (see my lecture "The
self, schizophrenia and neuroleptic iatrogenic injury in mental
health and social care").
provide meaningful involvement of users and survivors of psychiatry in all aspects
of psychiatric drug issuesespecially registration and monitoring of psychiatric
drugs, we must have involvement in ethics committees, licencing processes and
providing guidelines and decision making about effectiveness and reimbursement
of costs. Where such conditions do not exist, independent and user-controlled
research is needed on independent and user-controlled education and independent
and user-controlled information about effects of psychiatric drugs.
linked associations of psychiatrists and international drug companies, users and
survivors have to improve their efforts to cooperate internationally to exchange
information, best practice examples and to combine their special compentencies.
Better cooperation of user-controlled initiatives for research and training is
(1) The term "user
of psychiatry" refers to people who have mainly experienced psychiatric treatment
as helpful. The term "survivor of psychiatry" in turn refers to those
who have mainly experienced psychiatric treatment as being a danger to their health.
These definitions are often misunderstood: to "survive psychiatry" does
not mean that psychiatrists are being accused of trying to intentionally kill
people. But it does mean that diagnoses such as "schizophrenia" or "psychosis"
very often have a depressing and stigmatising effect, leading to resignation and
chronic hospitalisation. And it means that drug-effects such as neuroleptic malignant
syndrome or tardive dyskinesia or dystonic or epileptic attacks can be a danger
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Brussels, 22-24 April 1999. In World Health Organization
& European Commission: Balancing Mental Health Promotion
and Mental Health Care: A Joint World Health Organization
/ European Commission Meeting. Brochure MNH/NAM/99.2.
Brussels: WHO 1999, 9-10. Retrieved September 2, 2004, from
of the German citations by Peter Lehmann.
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