Biomedical Philosophies; Ethics and the Solitary Empiricist
Some biomedical philosophies provide tools with which the practice of medicine
can be analysed, and, theoretically corrected. To manage increasing demand, we
must ensure rational behaviour, encourage doctors to spend their time on
activities that revitalise rather than disable and prevent epidemics. I do not
decry the marvellous advances in medical treatment. But something more sinister
is happening on the streets.
In 1972, the fathers of the first National Health Scheme, Medibank, expected
that if better access to health care were made available, the health of the
nation would improve and we would need fewer doctors. How wrong they were.
Can doctors, or anyone, articulate and explain to politicians why it is that
when Medibank was first introduced, each Australian visited a doctor an average
of 2.2 times each year, and now that average lies between 12 and 15 times, and
the great majority of consultations still end with a prescription. There is
aging and AIDS, but they cannot account for it.
If we measure health by demand to see doctors, take medicines or use of hospital
beds, the fathers were very wrong indeed. Something around having more doctors
and more medicines appears to have created a problem.
Some people actually know what the problem is, and have known for 30 years. This
knowledge is unpopular, well documented and well repressed.
Two years after Medibank was introduced, in 1974, Ivan Illich published Medical
Nemesis about the epidemics of modern medicine, demonstrating how
doctors were responsible for the creation of the larger part of the ill health
that they treated.[i]
His book, according the British Medical Journal reviewer, sent a volley of
grapeshot across the bows of the medical establishment. Well, the navy is still
afloat, and the grapeshot has bounced off steel without even scratching it.
Morbidity, the professional word for the amount of sickness around can be
measured by disability, days off work, social security statistics,
doctor-patient contacts, hospital bed and costs.
I have researched two, much publicised, doctor-induced epidemics, examples of
the many system failures, RSI, the epidemic of arm symptoms that came and went
in the late 1980s and the current epidemic of mental illness that has escalated
since the early 1990s. This refers to the doubling of the numbers seeking
mental health care, the trebling of suicide attempts and completed suicide of
patients under mental health care.[ii][iii]Since
June 2001, an additional 257 mental health beds have opened. By June 2005, an
additional 40 beds will have opened.[iv]
What exactly is it that doctors do? In 1959, Baroness Shirley Wootton, a
philosopher in the House of Lords, suggested that a distinction needed be made
between what is treatable by medical means' and 'what doctors treat', that is
between what doctors do when they are behaving in the special fashion peculiar
to their profession, and what doctors do when they drop the Aesculapian mantle
(or white coat) and behave as ordinary men and women.[v]
No one took a scrap of notice, as taking on the medical profession is a risky
business for legislators.
When doctors determine who is, or is not, legitimately ill for the purpose at
hand, they are hiding behind a taken-for-granted authority and expertise in
this area. But as soon as they have to explain their decisions to ordinary men
and women, why one person complaining of symptoms is ill and the other not,
they soon come to the boundaries of medical knowledge.
Disease and illness are the central concepts in the philosophy of health.[vi]
After four years of scholarly analysis in learned journals of philosophy and
medicine, in the late 1980s, the conclusion reached was that they did not exist
other than in context, and could be defined only in terms of power. The
authority of the doctor alone determined just what disease and illness were to
be.
Medical power alone justified the intrusion of medicine into many spheres of
life.
Merskey, a psychiatrist, points out that it is commonly believed that one could
get away with anything with the help of a doctor's note, and he cites the
literary example of William Wycherley's Restoration Comedy, "The Country
Wife".
The plot turns on the deception practiced by a man who persuades his doctor to
put it about that he has become impotent so that his acquaintances trust him
with rather ready access to their wives and daughters.
Other possibilities for using a doctor's authority include Sick notes,
compensation payments, how much work it is safe to do, disability support, not
having to look for a job, housing, nursing and domestic help, legal excuses for
bad behaviour.
The key to all of this is that the doctor must write something, on an
appropriate letterhead, preferably, but not necessarily, in the language of
medicine, to signal that that the patient is not fully responsible for
inability to meet a social obligation and is therefore entitled to an
exemption.
In 1986, Merskey, a psychiatrist, suggested
"That what doctors treat can be accepted as disease provided that we
recognise that the significance of disease must vary with circumstances."[vii]
Merskey's definition fails and must fail because it is entirely circular, yet it
cannot be ignored as it is precisely this view of illness and disease that
informs today's debate, passes for "common knowledge" and forms the
rationale for the interventions of doctors into all spheres of life, stress,
crime, marriage problems and common human unhappiness.
Jeremiah Barondess, a physician, cut actress the debate with a Wittgensteinian,
linguistic solution, Disease, he said is a biological event, characterised by
anatomical physiological or biochemical changes or by some mixture of these. It
may persist, advance or regress through a variety of mechanisms and may or may
not be clinically apparent. Illness, on the other hand, is a human event, the
product of stressful life events or a reaction to a threat. The stress causing
illness may be a disease, but often it is not. Half of all of doctor patient
contacts take place without a definable biologic basis.[viii]
So illness and disease are not the same thing. Disease is in the body, and can
make you ill, or not.
Illness is the product what you feel and fear and that and it can give you
symptoms the body as well.
Treating the somatic manifestations of illness like tiredness and aches and
pains, will not make causal stress go away. Somatic, from soma, refers symptoms
being experienced in the body but does not mean that the affected part of the
body is diseased. This generates costs and makes little difference to the
patient's condition, other than to persuade her that she is incurable. The pain
is real, and to a non-professional, indistinguishable from pain that is
underpinned by disease. Doctors can be learn to tell the difference but it is
simply not in their interests to know, for a number of reasons: They need to be
sure or they can be embarrassed, and it is harder to deal with social stressors
in a 'medical' way if one really has to confront the fact that stress is making
the patient sick.
We do not expect to find local pathology in weak knees in an anxious person, nor
the chest wall where stress related pain is often felt. Body parts can be
sensitised by a variety of mechanisms, not least, beliefs and fears about their
condition. The RSI epidemic provided us with an example of what happens if
three government departments, and many trade unions, clinics and teaching
hospitals al focus on the arms of workers.
The relationship between disease and illness is taken for granted but it is
complex. Some disease, like malaria, are accompanied by toxic illness, whereas
others, such as advanced heart disease and cancer may or may not make you ill,
until it is too late.
In 1988, Jurisprudence Professor, Ian Kennedy, reasoned that unquestioned
jurisdiction over the determination of what was and was not an illness gave
doctors unlimited power.[ix]
He pointed out that the notion of 'possession' (as in demonic,) had not fallen
before the onslaught of scientific medicine but has been retained, in that the
body of an ill person is now suspected, almost assumed, to be 'possessed' by
disease, even in cases where the only evidence for disease is a complaint.
Kennedy saw that the doctor encouraged the process whereby he was seen as the
purveyor of panaceas. Even though doctors would be the first to deny having
any, it was gratifying to their perception of themselves as helpers, as it
guaranteed they would never cease to be wanted. Quite simply, it gave doctors
power.
The panaceas come from drug companies, collectively known as PhaRMAs. The term
PhaRMA comes from the initials of the Pharmaceutical Research and
Manufacturers of America. If they sell a lot of drugs, they make big profits,
and they can do that only by influencing doctors to prescribe their drugs.
The profession of medicine has always accommodated two divergent and
complementary philosophies: rationalist and empiricist. I would argue
that, when practiced by individuals, empiricism, which is currently dominant,
is not rational and is therefore unethical.[x]
These philosophies have their roots in the cults of the god Aesculapius, his
daughters, Hygaeia and Panacea and their followers, rationalists and
empiricists.
Hygaeia symbolised the belief that men would remain healthy if they lived wisely
and within the laws of reason. Today we have hygiene, and the motto, 'mens sana
in corporo sano,' a healthy mind in a healthy body.
Panacea, muse to the empiricists, embodied the illusion that there are remedies
available for all problems. She specialised in the knowledge of drugs and
symbolised the belief that ailments could be cured with herbs and earth
substances.
Empiricists rejected the study of anatomy and physiology as having no bearing on
the practice of medicine. Their modern counterparts care little about
diagnosis, only about treatment. Their philosophy was scepticism; that all
knowledge was uncertain, that the only valid reasoning in medicine was by
experience, experiment and analogy. They ask me, facetiously, ÒHow so you
know?Ó And then they do not wait for an answer.
The delivery of empirical remedies itself is not considered unethical. However
it involves a certain amount of optimistic self-deception by the physician and
not telling the truth to the patient. There is no hope of effecting a cure with
an empirical remedy, or anything better than a temporary placebo response.
Treatments that lay no claim to efficacy are called 'placebos', with 'placebo'
meaning ÒI shall please.Ó Note the future tense, which make us doctors feel
better, do better.
Philosopher Sisela Bok has argued against the use of placebos on ethical
grounds. She makes the points that they involve deception and so they cannot be
given with the informed consent of the patient.[xi]
She points out that such practices cumulatively generate huge costs and burdens
without improving the health of a community.
According to Eliot Freidson, a physician philosopher writing in 1970s, the North
American physician is a crude pragmatist and not a scientist. He looks at the
world through a medical gaze, and his aim is not knowledge but action.[xii]
He prefers unsuccessful action to no action at all. The tendency to take action
for its own sake is based on the assumption that doing something is better than
doing nothing.
As most illnesses get better without medical intervention such a practitioner
needs to believe that he does good rather than harm, that what he does made the
difference between success and failure. He prefers his own 'clinical
experience' to book knowledge.
He argues that he cannot suspend action in an emergency simply because he is
uncertain and this provides him with grounds to justify his pragmatism.
But then he then behaves the same pragmatic way when managing conditions that
pose no danger to life at all.
In his haste, he might well mistake a symptom of illness for a symptom of
disease, and act accordingly by delivering a physical remedy, and thereby
creating in the patient a belief that he had a disease.
To give an example where empirical action is justified: To a general
practitioner, late at night, all chest pain suggestive of a heart attack must
be acted on as if it were a heart attack, sent to hospital for a cardiogram,
possible intensive care and enzyme tests. Nine out of ten will be
stress-related 'illness'.
Of those who are ill, eight will be happy to have no disease, but the occasional
patient will find or seek out a doctor who is willing to maintain him in the
sick role by advising that he 'nearly had a heart attack' and must in future
avoid stress. He stays sick, might not get back to work.
Too often, the physician who prescribes placebos has not made a diagnosis.
Incapable of mitigating the social stresses that are manifesting as illness in
the patient's body, he is prone to see the patient's predicament through a
medical gaze, to suspect disease, and then feel that he has the obligation do
something rather than nothing, better be safe than sorry and so on.
He is deceiving both himself and the anxious patient and getting paid, and he is
likely to be unaware of what motivates him to do so. He would have a dozen
reasons and my analysis would release indignation. He would argue that
nowadays, as panaceas abound, that he uses active drugs, not placebos.
But active drugs used as placebos not only cannot cure: they might have side
effects that cause further problems.
Empiricism is the practice of doing something rather than doing nothing. It
takes us back to the 17th Century when the symptom was the disease.
That which could not be seen with naked eye was not known.
Scheff, a sociologist, examined the medical literature concerning functional
illness, and identified the process by which the physician unnecessarily caused
the patient to enter the sick role. Scheff rejected the notion that illness was
'functional,' in the sense of useful, for the patient. He took the position
that the cause of 'functional disease' laid in faulty medical procedures and
the frequency with which physicians made incorrect diagnoses and treated
patients for non-existent diseases.[xiii]
It goes without saying, by the axiom, that misjudging a sick person to be well
is more important to avoid than judging a well person to be sick. The doctor
who misses the real heart attack is reviled by his peers, criticised by his
patients and may attract a negligence suit.
Nothing is done about the doctor who tells the man with clean coronary arteries
that he 'nearly had a heart attack' disables him with an incorrect diagnosis.
Some patients would go elsewhere and seek a second opinion, but such a doctor
acts as a magnet for patients with psychosomatic illness. Primed for vitamin
infusions and placebos, they enter a pas de deux of simulation and collusion to
maintain in both parties the illusion of sickness and treatment.
Scheff questioned that telling people that they had a disease when they did not,
was harmless, and that placebo treatments were harmless and that it was better
to be safe than sorry and use an active drug, 'just in case'.
Following the 'better safe than sorry' rule placed in the sick patient role
people who could otherwise have got on with their normal pursuits.
The medical profession did not take this seriously, but Scheff believed that
such mistakes profoundly influenced the course of an illness or even a life.
Show me a patient, ill with no disease, says Scheff's theory, and I will take
you back to a mistaken diagnosis by a doctor that is at the base of it.
The notion of rationality has permeated philosophy from its beginning.
Rationality equates with goodness. Rational choice theory, Racho, as it is
fondly called, is well explained by Jon Elster (1994).[xiv]
In brief: people i.e. patients and doctors, individuals (or groups like PhaRMAs)
seek to achieve their desires, by doing something (or nothing) or acting (or
not acting,) in accordance with what they believe to be true, against a
background of social norms and social values, which tell them what is a good
outcome or achievement, and what is permitted or not, and what they can get
away with, in order to maximise their desires.
That's simple enough. We go for what we want, as hard as we can, within the law
and without upsetting others too much, and we are guided by what we believe
will achieve those goals. If it is health we want, we think we, or our doctors
know how to achieve it.
In 1982 Culver and Gert adapted rational choice theory and applied it to medical
practice. They argued that a direct but underground connection existed between
rationality and ethics so that only rational medical diagnosis and treatment
constituted ethical behaviour.[xv]
Rationalists, unlike empiricists, maintain that knowledge about the human body
is essential, as are true beliefs, good diagnoses and remedies that provide
what is expected. Rationality contained two inter-connected elements: 'the
holding of true beliefs' and 'the maximising the satisfaction of one's
desires.'
A rational treatment is one designed to bring about remission or cure of the
relevant disease
Rational choice theory is based on the notion that rational action is that which
maximalises desires and the ultimate desire or 'good' within the practice of
medicine is health.
Rational choice theory can analyse the actions of patients and doctors and any
stakeholder, their beliefs and desires, their reasons and motives doctors to
identify where problems exist, where medical care went wrong.
Rational practice is predicated on the assumption that the patient wishes, above
all, to be restored to a state of health forthwith and that the physician is
capable and has no greater desire than to restore that patient to health. It
also assumes adherence to the Hippocratic oath: Primum non nocere. Above
all else, I will do no harm. This is not an absolute, as some treatments have
harm among their side effects.
Beliefs are imperfect in a variety of ways and held for a myriad of reasons,
people stop collecting evidence when they find one that suits them. Desires are
not always achievable and costs are involved, so they are placed in a
hierarchy, by individual preference. Treatments carry risks and side effects,
not all goals are reliably achievable, Desires are often in conflict with each
other and choices are made, usually unconsciously, against a matrix of personal
values.
Being sick holds attractions where it is rewarded by institutional and cultural
arrangements, compensation, sick role and pensions.
Motives concern some good, which is to occur in the future. Reasons are based in
the past, and are dependent on beliefs.
Motivation to maintain self or another in ill health is unconscionable. It is
usually unconscious precisely because it conflicts with conscious goals, values
and ideals.
Medical decisions are made in accordance with beliefs about the body, and false
beliefs abound and are promoted. Disease mongering exaggerates the danger of
blood pressure, depression, menopause and work. Awareness campaigns are backed
by vested interests; PhaRMAs hold out a remedy to eliminate these newly
identified risks.[xvi]
When exposed to disease awareness campaigns, some clinicians do not recognise
that the PhaRMA is trying to move the goalposts, to persuade them to diagnose
hypertension and ten points lower, diabetes with only occasional high blood
sugar, diagnose 'depression' where others would see unhappiness, stop
collecting evidence about the patient's condition. Reassured of their skills by
the propaganda machine and glossy brochures, they no longer need the views of
others who might challenge their beliefs, they ignore negating evidence when it
suits them to do so, they beliefs and desires stay in a balance when they know
just enough to justify their practice. Their newly acquired knowledge is so
tainted that they find it hard not to diagnose a much-promoted condition where
there is the slightest suggestion of it.
The beliefs that they choose are those that conform with their own desires,
which might include all those goods external to the practice of medicine,
money, fame and popularity.
Making the incorrect diagnosis or administering treatment without known efficacy
constitutes neither rational nor ethical behaviour for a physician.
Closer and Gert made the point that actions based on false beliefs were usually
irrational, primarily because such actions did not, and could not succeed.[xvii]
The tragic fact is that medical education of our doctors, and medical students
is in the control of vested interests, colleges, professional groups,
professional associations, pharmaceutical companies that control journals and
fund conferences. John Merson calls this problem 'epistemic capture.'
Now for some examples:
In the 1980s, a small group of doctors created tens of thousands of cases of RSI
because they were told by a group of vested interests, the occupational health
lobby, that symptoms in the arms of workers were evidence of traumatic disease.[xviii]
They were identified to get referrals (read: popularity, money) if they were
prepared to provide certificates to remove afflicted workers from their tasks
lest they become even more injured, to the point of total and permanent
collapse, stage 5 of RSI.
Had they given the appropriate consideration to the sudden appearance of RSI,
its symptoms and its epidemiology and distribution in the workforce, they could
not have operated on, splinted or medicated or antidepresssed and disabled
hundreds of thousands of workers.
Writers' cramp, a mental and behavioural disorder, had become epidemic every
other time in history when doctors were encouraged to pay attention to arm
symptoms and were generously rewarded for providing useless remedies.
The example of depression
To practice ethically and rationally, to respect choice and autonomy,
prescribers have to make their patients aware of side effects. But drug
companies do not tell doctors enough for them to get informed consent. Informed
consent and patient autonomy are basic tenets of medical practice.
In recent years, Australia and the United Kingdom have been exposed to campaigns
to identify and defeat depression Ð funded by PhaRMAs that desired a large
population to use their new products, loosely termed 'antidepressants.' A
cultural phenomenon, some like Prozac and Zoloft are household words.
It was known that 'biological depression' the condition, which carried a high
lifetime, risk of suicide was a rare condition and the suicide rate of could be
halved by existing drugs, tricyclics, known as TCAs. As a last resort, ECT or
shock treatment was very effective.
Then came a new group, serotonin boosters, mood brighteners, which did not work
on biological depression but had the effects best described as 'activating' s
if taking small doses of cocaine and amphetamines, but legal.[xix]
Prozac was not the first, but because of a cunning promotional campaign it hit
the ground, running. Eli Lilly told the public through a massive publicity
machine it caused weight loss.
That turned out to be a lie, as it does the opposite, stacks on weight.
To get doctors to prescribe them, they lied that they were not non-fatal in
overdose but this is not true of all of them.
In order to find a market for these substances, PhaRMAs marketed a new 'disease'
by promoting a notion that a shortage of serotonin was the cause of depression,
and that their serotonin booster could 'correct this imbalance.'[xx]
Another lie: Serotonin has never been found to be abnormal in depression and 90%
of it is in the gut, not the brain anyway.
This lie defined 'depression' as a 'disease' and not an illness, which you will
recall from the Barondess definition, is a human event by stress.
The clever marketing of 'depression' as the disease of having low serotonin
levels, which these drugs correct, created a false belief system, which
profoundly influenced the collective actions of doctors.
The indications for these new drugs had been expanded to include anxiety (which
makes people miserable, but does not kill them), obsessive compulsive, eating
disorders, unhappiness, grief, rage, the consequences of failure and abrasive
relationships at work.
These human ills were converted into a disease state so successfully that 4.7%
of the Australian population, or one adult in twenty, currently takes an
antidepressant, and they believe they are correcting a deficit condition like
diabetes.
As with heart attacks being a side effect of the painkiller, Vioxx, there is an
ugly underbelly.
New drugs never have side effects, because we do not know about them. Studies
kept coming in, telling doctors that one person in 20 who took these wonder
drugs got more not less depressed, one in 70 became suicidal and one in 500
committed suicide. Many others became psychotic or violent.
We were repeatedly reassured that antidepressants did not cause suicide with the
mantra, ÒIt's the disease, not the drug doctor.Ó But this did not wash
when the patient was being treated for grief, mourning, anxiety or menopause,
conditions with zero suicide risk. And they knew all along, as they did about
Vioxx.[xxi]
We now know that between two and eight times as many people were killing
themselves on these drugs than would have done if left alone with their
miseries or taking sugar pills and having conversations weekly, 200/100.000 v
30/100,000 on sugar pills or untreated.[xxii]
Improbable candidates on antidepressants were committing homicide followed by
suicide.
The availability of a remedy for depression has caused a thousand fold increases
in its diagnosis. And their lethal side effects have increased by the same
multiplier.
In September 2003, the publication of studies from the United States Food and
Drug Administration showed that the manufacturers of the new generation of
antidepressants had hidden these suicides from both doctors and patients.
Congressional Hearings and a House of Commons inquiry followed, but Australia
still has not posted FDA warnings about suicide.
This seems to have been a political decision that invites ethical analysis.
When PhaRMAs engage with doctors and governments, rational choice theory
analysing their actions, what pass for their beliefs alongside outcomes would
suggest that they have but one desire: profits.
In the United States, the fourth highest cause of death after heart disease,
cancer and strokes are adverse drug reactions, known as ADEs. They are
responsible for over 105,000 deaths each year. They fill hospitals their
sublethal side effects, which do not get diagnosed because doctors were not
told there were any side effects. If one adds improperly prescribed drugs and
those taken incorrectly, ADEs become the third highest cause of death.[xxiii]
A score of drugs licensed in the 1990s have been withdrawn for lethality which
apparent in clinical trials but not disclosed to prescribers or patients. The
recent withdrawal of Vioxx followed hundreds of thousands of heart attacks, 50
to 100 planeloads of lethal heart attacks. Vioxx was defended, as 'safe' until
two weeks before its withdrawal, by what might be Merck's, the manufacturers,
last breath.[xxiv]
PhaRMAs select their promotional material out of a hierarchy of beliefs,
selecting those that suit their desire, profits; they create, amend, massage
and tailor the beliefs they promote.
Doctors were told that Vioxx does not cause excess heart attacks, but that
Naprosyn, which was the comparator drug in these studies, protected from heart
attacks.
We are reassured that a schizophrenia drug, Zyprexa does not cause suicide, but
clozapine reduces suicide risk by 75%.[xxv]
Yet one in every 208 patients in the Schizophrenia trials committed suicide in
the FDA trials, and one on comparator drugs.[xxvi]
PhaRMAs know their drugs cause harm to some users and decide, on commercial
grounds, to lie, provide doctors with false beliefs and face litigation while
pursuing market share.
They tell lies, misinform their lay educators, who charm us with their dinners,
wines, pens, gimmicks and luxury conference funding, and generous honoraria for
speakers, termed 'opinion leaders' who are willing to transmit beliefs
favourable to them.
They donate to political parties both sides of the aisle. That of course, is
another area of ethics, subject to changes in societal norms and values.
Government leaders accept PhaRMA hospitality. Health ministers have been known
to cut out experts, to order multimillion-dollar purchases of drugs on
information provided in company summaries as opposed to demanding to know how
they performed in clinical trials.[xxvii]
Lawsuits by individuals are afoot but, more significantly, attorneys general in
a score of American States are taking legal action against the drug companies,
with budgets the size of small European countries, expecting to recoup hundreds
of millions of dollars that the side effects of deceptively advertised
medicines have cost the health care providers. New York's Attorney General,
Eliot Spitzer, won a settlement of $US430 million against Warner Lambert, a
subsidiary of Pfizer,
Inc. for illegal and deceptive promotions of one of its blockbuster drugs,
Neurontin. Spitzer said. ÒMarketing strategies that deceptively and illegally
promote drugs for unapproved purposes in order to increase a pharmaceutical
company's bottom line will be aggressively investigated.Ó[xxviii]
It is too frightening not to trust. There is an inclination to assume both good
will and competence to doctors.
Gorovitz and McIntyre in their paper "Towards a Theory of Medical
Fallibility" warn:
The physician's propensity for damaging error is widely denied, perhaps because
it is so widely feared."[xxix]
Politicians fear doctors and their power. No political party can stand images of
sick babies awaiting humidicribs, or men on crutches awaiting surgery, no
matter that they know they are being manipulated.
In 1974 Ivan Illich popularised a technical term, iatrogenesis, for what was
then a Ònew' epidemic of doctor-made disease, composed of the Greek words for
'physician' (iatros) and for 'origins' (genesis).
It was clinical, when the pain, sickness and death result from the provision of
medical care.
It was when social, when the organization of health care generated dependency
and ill health, and
It was structural where doctors, and their delusions of efficacy, undermined
natural confidence of ordinary in caring for each other.
In his critique of Illich, the Marxist, Vicente Navarro saw iatrogenesis as a
by-product of the struggle between the powerful classes and the less powerful.[xxx]
In his explanation, responsibility for iatrogenesis did not lie with the medical
profession at all, and but with the powerful corporate classes which had a
dominant influence in health care delivery. These were big PhaRMA, big
business, governments; insurance companies all of which determined how and what
kind of health care was to be delivered.
[i]
Illich I. Medical nemesis. Lancet 1974;1(863):918-921.
[ii]
Report Of The Nsw Chief Health Officer. Mental Health Suicide Attempts
[iii]
Tracking Tragedy; The Report Of The Nsw Mental Health Sentinel Events
Committee.
[iv]
The NSW Government's Plan for Mental Health Services. NSW Government 2005
[v]
Wootton B, Seal VG, Chambers R. Social Science and Social Pathology.London:
George Allen and Unwin Ltd, 1959
[vi]
King L. Some basic explanations of disease: an historian's viewpoint. In:
Engelhardt HT, Spicker SF, ed. Evaluation and Explanation in the
Biomedical Sciences: Proceedings of the First Trans-disciplinary Symposium on
Philosophy and Medicine, held at Galveston, May 9-11, 1974. Dordrecht: D
Reidel Publishing Company, 1975: 11-27.
[vii]
Merskey H. Variable meanings for the definition of disease. Journal of Medicine
and Philosophy 1986;11(3):215-232.
[viii]
Barondess JA. Disease and illness - a crucial distinction. American Journal of
Medicine 1979;66(3):375-376.
[ix]
Kennedy I. The Unmasking of Medicine.London: George Allen and Unwin, 1981
427. Kennedy I.
What is a medical decision? In: Kennedy I, ed. Treat Me Right: Essays in
medical law and ethics. Oxford: Clarendon Press, 1988: 19-21.
Kennedy I. The patient on the Clapham omnibus. In: Kennedy I, ed. Treat
Me Right: Essays in medical law and ethics. Oxford: Clarendon Press,
1988: Kennedy I, Grubb A. Medical Law: Text and materials.London:
Butterworths, 1989
[x]
Veith I. Hysteria: The history of a disease. Chicago: The University of Chicago
Press, 1965.
[xi]
Bok S. Lying: Moral choice in public and private life.New York: Vintage Books,
1979
[xii]
Freidson E. Profession of Medicne.Chicago: University of Chicago Press, 1970
[xiii]
Scheff TJ. Decision rules, types of error and their consequences in medical
diagnosis. In: Tuckett D, Kaufert JM, ed. Basic Readings in Medical
Sociology. London: Tavistock Publications, 1978: 245-253. Scheff first
published his ideas dealing primarily with psychiatric issues in Being Mentally
Ill: a sociological theory. Chicago, Aldine 1966.
[xiv]
Elster Jon.; Rational choice theory. In: the Polity reader in social theory,
Cambridge. P121-32.
[xv]
Gert B, Clouser KD. Rationality in medicine: an explication. Journal of
Medicine and Philosophy 1986;11:185-205.
[xvi]
House of Commons Health Committee. The Influence of the Pharmaceutical Industry
Fourth Report of Session 2004-05 Volume I
[xvii]
House of Commons Health Committee. The Influence of the Pharmaceutical Industry
Fourth Report of Session 2004-05 Volume I
[xviii] Lucire,
Yolande Constructing RSI: Belief and Desire. 2004 UNSW Press.
[xix]
Healy D. Let Them Eat Prozac: the Unhealthy Relationship Between the
Pharmaceutical Industry and Depression. New York; 2003.
[xx]
Regulator slaps Pfizer on Zoloft ads. FDA orders No. 1 drugmaker to halt ads
neglecting to warn of antidepressant's fatal side effects. May 6, 2005: 5:14 PM
EDT WASHINGTON (Reuters) - A Pfizer Inc. advertisement for antidepressant
Zoloft left out an important warning about the risks of worsening depression or
suicidal behavior in patients taking the drug, regulators said on Friday. The
Food and Drug Administration told Pfizer to immediately stop using any similar
promotional materials that omitted the warning. The original ad ran in The New
York Times Magazine in October 2004. The ad raised public health concerns
"because it fails to include a serious risk associated with the
drug," the FDA said in a letter to the company. The FDA asked Pfizer and
other antidepressant makers in March 2004 to add warnings about the possibility
that patients taking the drugs could experience worsening depression or
suicidal thoughts or actions. Pfizer added the warning to the Zoloft label in
July 2004 but failed to include the new information in the magazine ad, the FDA
letter said.
[xxi]
THE WASHINGTON POST Merck CEO Resigns as Drug Probe Continues By Marc Kaufman
May 6, 2005 A-1 Merck & Co.'s longtime leader Raymond V. Gilmartin abruptly
resigned yesterday on the same day congressional investigators released a slew
of documents detailing how the company continued to aggressively promote its
arthritis drug Vioxx after it knew of potentially serious safety concerns. The
documents made public by the House Committee on Government Reform showed that
Merck directed its 3,000-person Vioxx sales force to avoid discussions with
doctors about the cardiovascular risks identified in a major clinical trial of
the drug in 2000. Sales representatives were told instead to rely on a
"Cardiovascular Card" that said Vioxx was protecting the heart rather
than potentially harming it. Vioxx was withdrawn from the market last September
after another clinical trial found that people who had taken the drug for 18
months were five times more likely to have heart attacks and strokes than those
on a placebo. The withdrawal tarnished Merck's reputation and cost the firm
billions in sales, stock value and legal fees. The company, which had earlier
said Gilmartin, 64, would stay in place until his scheduled retirement next
year, said his sudden departure as chairman, president and chief executive
officer had nothing to do with the Vioxx controversy. Merck named its president
for manufacturing, Richard T. Clark, to replace Gilmartin as chief executive
officer and president. The resignation of Gilmartin, after he spent 11 years at
the helm, came on a day when Merck was sharply criticized in a hearing into how
the company and the Food and Drug Administration had handled the safety
concerns surrounding Vioxx. Merck and other drug companies say their
"detailers" act as neutral educators to guide physicians in
prescribing drugs, but the more than 20,000 pages of documents released
yesterday showed that Merck's representatives were coached to be aggressive
salesmen. They were trained how to smile, speak and position themselves most
effectively when talking with doctors, and were exhorted to sell Vioxx and
other Merck drugs using the Rev. Martin Luther King Jr.'s "I Have a
Dream" speech. Rep. Elijah E. Cummings (D-Md.) read from a Merck training
manual that directed instructors to play a recording of the speech and then say
to the sales force: "King was someone with goal-focus -- he kept getting
shut down but kept going. . . . Just as with a physician, you must keep
repeating the compelling message and at some point, the physician will be 'free
at last' when he or she prescribes the Merck drug, if that is most appropriate
for the patient." "Merck says the mission of its sales force is to
educate doctors," said Rep. Henry A. Waxman (Calif.), the panel's ranking
Democrat. "This sales force is given extraordinary training so that it can
capitalize on virtually every interaction with doctors. Yet when it comes to
the one thing doctors most need to know about Vioxx -- its health risks --
Merck's answer seems to be disinformation and censorship." Dennis Erb,
Merck's vice president for global regulatory development, said that company's
actions were timely and appropriate, and that detailers were trained to be
"accurate and balanced" in presenting information. He said Merck has
conducted 70 clinical trials on Vioxx involving more than 40,000 patients, and
the company is discussing with the FDA whether to apply for approval to resume
marketing the drug. "We believe Merck acted appropriately and responsibly
to extensively study Vioxx after it was approved for marketing to gain more
clinical information about the medicine," he said. "And we promptly
disclosed the results of these studies to the FDA, physicians, the scientific
community and the media." Erb defended Merck's policy of instructing its
representatives not to tell doctors about the troubling cardiovascular results
from a large 2000 clinical trial called Vigor. Until it withdrew Vioxx, Merck
had argued that naproxen -- the control drug in the 2000 trial -- lowered
cardiovascular risks, not that Vioxx raised them. Erb said the FDA had not
approved adding the trial results to the drug label and so they could not be
discussed except by senior officials. But Erb acknowledged that the company did
allow drug representatives to say that the 2000 trial had established that
Vioxx helped reduce gastrointestinal bleeding. That policy led some congressmen
to accuse Merck of disclosing the good news about Vioxx but hiding the bad.
Rep. Gil Gutknecht (R-Minn.) joined Democrats on the committee in sharply
questioning Merck and the FDA. "It seems to me there's a disconnect
here," he said. "You're saying your policies are legal, but are they
ethical? Isn't this the scandal?" A 2004 study by FDA safety officer
David Graham and others estimated that Vioxx caused as many as 140,000 heart
attacks and strokes and killed as many as 55,000 people. Vioxx, which was
approved by the FDA in May 1999, reached $2 billion in sales in two years,
faster than any drug in Merck's history. The FDA's Steven Galson, acting
director of the Center for Drug Evaluation and Research, also came under
criticism for the agency's handling of the Vioxx case, especially for the
substantial lag time before the worrisome cardiovascular data from the 2000
trial were added to the drug's label. Galson said the agency had learned
through the Vioxx episode that it should give doctors and patients more
information about drugs as the incomplete research results come in. "The
most important lesson . . . is that the American public, practitioners and
patients want to get clear and accurate information as early as possible so
they can participate in their own health care decisions," Galson said.
The hearing also explored previously reported efforts by Merck to
"neutralize" doctors who had concerns about Vioxx's safety by paying
them to take part in clinical trials and offering grants and consultancies.
Merck officials said their efforts were designed to dispel misinformation about
their product Until the Vioxx debacle, Gilmartin and Merck were highly regarded
in the pharmaceutical industry. Gilmartin was a pioneer in providing cheap or
free AIDS drugs to Africa, and Merck was long considered one of the most
ethical -- and profitable -- companies. Since Sept. 30, the company has lost
one-third of its stock value. In a conference call yesterday, Lawrence A.
Bossidy, the new chairman of the Merck board's executive committee, said of
Gilmartin, "In no way did we push him out." He said the company
decided it was "time for change."
Gilmartin's successor, Clark, 59, has been president of Merck's manufacturing
division, which operates plants in 25 countries. Clark also served as chief
executive of Medco Health Solutions Inc., one of the country's biggest managers
of prescription drug programs.
[xxii]
Healy D, Whitaker C. Antidepressants and suicide: Risk-benefit conundrums.
Journal of Psychiatry & Neuroscience 2003;28(5):331-337.
[xxiii]
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in
hospitalized patients: a meta-analysis of prospective studies.[see comment].
JAMA 1998;279(15):1200-5.
[xxiv]
1 10 04 The Associated Press reports: "Merck pulled Vioxx after admitting
studies showed the drug raised the risk of heart attack. As recently as August,
Merck "strongly" disagreed with studies showing the drug increased
heart attack risk, and had recently gained FDA approval to market the drug to
children."
[xxv] Meltzer
HY, Alphs L, Green AI, Altamura AC, Anand R, Bertoldi A, et al. Clozapine
treatment for suicidality in schizophrenia: International Suicide Prevention
Trial (InterSePT).[see comment][erratum appears in Arch Gen Psychiatry.2003
Jul;60(7):735]. Archives of General Psychiatry 2003;60(1):82-91
[xxvi] Mary-Anne
Toy, Heath Editor Friday December 1 2000, the Age Melbourne.
[xxvii] Pharma
Watch Thursday, February 17, 2005.
http://pharmawatch.blogspot.com/2005/02/apology-from-dr-michael-wooldridge.html:
An apology from Dr Michael Wooldridge Hello. I'm Michael Wooldridge. It's
been five years since as health minister I went against the advice of my expert
committee and gave an enthusiastic endorsement of Celebrex. They recommended
caution, but I approved it for PBS subsidy, and enthused about how it would be
good news for arthritis suffers. I was joined by Pfizer-sponsored groups such
as Arthritis Australia in celebrating this wonder drug. And Pfizer-sponsored
medical opinion leaders were effusive in their praise of the coxibs. Now with
the demise of Vioxx and the spotlight on Celebrex safety, the experts on the
PBAC committee whose advice was over-ruled have been proved right. But what has
happened to them? I fired Professor David Henry and he was then subject to a
smear campaign by the pharma industry-funded PR firm Susan Andrews
Communications. Meanwhile, I have moved on, and many of my staff are now
working in the pharma industry. Well, I would now like to apologise to the
great Australian public for getting it all so hopelessly wrong. And I know
Arthritis Australia and the opinion leaders would also like to confess their
mistakes. Celebrex and Vioxx have cost us hundreds of millions of dollars a
year, and for what? A much-hyped GI safety advantage that has never been
demonstrated in long term use and is offset by more heart attacks and strokes.
Now, let's draw a line under it all and ask Pfizer and Merck to refund all that
wasted money.
[xxviii]
Press Release: Office of Elliot Spitzer May 13, 2004
http://www.oag.state.ny.us/press/2004/may/may13b_04.html
http://www.centerwatch.com/patient/nmtresults/index.html
[xxix]
Gorowitz S, MacIntyre A. Toward a theory of medical fallibility. Journal of
Medicine and Philosophy 1976;1(1):51-53.
[xxx]
Navarro V. The industrialisation of fetishism: a ctitique of Ivan Illich.
In: Medicine under Capitalism. London: Croom Helm, 1976: 106-118.
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