Towards evidence based bioethics
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7521.901 (Published 13 October 2005) Cite this as: BMJ 2005;331:901All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
If ethical constructs are contingent on outcome then it might be
argued that ethics can and should be ‘evidence-based’[1]. However, there
are good reasons to argue that at best such evidence can only inform
ethical discourse rather than provide ethical solutions. This can be
demonstrated by considering the issue of abortion. Those who argue the
primacy of the right of a pregnant woman to choose would not be swayed by
any of the empirical information about fetal development, numbers of
terminations or outcome. Pregnant women may be influenced by such
information in the choice they make, but the pro-choice argument holds
that they have a right to take responsibility for the decision in the
light of their own particular circumstances. Nor would such empirical
information affect the arguments of the ‘pro-life’ position which holds
that the fetus, as a person, has the right to protection from harm. The
‘pro-life’ and ‘pro-choice’ arguments are diametrically opposed positions
which cannot be resolved by empirical evidence alone, although it is not
inconceivable that such information may sway people to one camp or the
other .
Consider, however, the position of those who hold that ‘unnecessary
abortions are wrong’, the converse of which is that ‘necessary abortions
are right’. It might be argued that this is clearly dependent on empirical
information about necessity. Yet again such evidence can only inform
rather than determine any judgement. We might consider sets of criteria
that would make a termination necessary, but such a choice can only be
made as a value judgment on which the evidence itself can be only an
influence. We might decide that it is only necessary and justified where
there is a grave threat to the life of the pregnant woman and we may also
decide that this is best determined by clinicians on purely clinical
criteria . Nevertheless, this provides a legalistic solution rather than
solving any ethical dilemma and again the decision can only be informed
by the ‘evidence’ rather than determined objectively or free of any value
judgments.
Science might be able to show in some circumstances whether or not
suppositions on which any position might depend are likely or turn out to
be false, but it cannot provide an objective ethical position. This is
clearly so with the issues arising from putting very premature babies into
intensive care. Let us consider two positions. Recent investigations
demonstrate very severe levels of brain damage and mental and physical
handicap in a significant proportion of these babies and as a result some
argue that the potential harm outweighs any benefit of keeping them alive
in intensive care – position (a) . Others argue that all babies have a
right to life and every effort should be made to keep them alive –
position (b). Furthermore, they argue that judgments about the value of
life cannot be made on the basis of presumed or predicted levels of
handicap . Science certainly informs the debate, but it is difficult to
see how the results of such investigations of outcome can make any
difference to these positions, although of course if the evidence showed
no risk of brain damage then clearly the argument given in position (a)
would be invalid. Position (a), however, arises from the evidence itself
and from the consideration of a duty not to do harm. In contrast, position
(b) is not dependent on the evidence and gives a primacy to the duty to
preserve life. In the absence of a general policy, say (1) not to keep
very premature babies in intensive care - is in Holland - or (2) to give
all such babies a chance to life with intensive care , decisions would
have to be made on a prognosis of outcome in each case - as in UK (3). All
three positions are supported by the results of scientific investigation:
position (1) on the grounds that some babies will be profoundly damaged,
position (2) on the grounds that some babies are normal and on the
intrinsic value of a life whether handicapped or not, and position (3) on
the grounds that some babies may survive better than others and that at
least this will give a chance to those who appear to have the better
prognosis.
There is a clear difference between evidence obtained in a process
which sets out to test a given hypothesis about the nature of things and
data collected together or selected to make a particular case or value
judgement . This distinction is clear when we analyse the following
statement: “It is scientifically established that from the moment of
conception when a single-cell embryo is created, a new human being or
organism exists.” This use of ‘science’ is an appeal to a supposed
objective truth. Yet examination of the statement reveals it to be
dependent simply on a particular definition of a human being or organism.
As such it is a value judgement and there are no doubt scientists whose
definition of human being would lead them to agree that a human being
exists from conception. But there are equally others whose definition of a
human being is such that they would prefer to use the term ‘human embryo’
to signify that it isn’t a human being, but rather that it is a human
becoming, a potential human being, an embryo that will become a human,
just as they prefer to make a distinction between frog spawn, tadpoles and
frogs. They prefer to define a human being as a man, woman, or child of
the species Homo sapiens. Science as an evidential process can provide
little further insight to resolve this difference of view. Yet it is
precisely this difference of view that leads to fundamentally different
positions on issues such as abortion, human stem cell research,
therapeutic cloning or assisted conception and embryo selection.
We may believe that science offers an objective, value free, neutral
position. But in as much as this is true, it is a view from nowhere. The
crucial thing about ethics is that it deals with value judgements and
duties which cannot be resolved in a test-tube.
1. Scott D Halpern Towards evidence based bioethics
BMJ 2005; 331: 901-903
2.http://www.prolife.org.uk/about/keyabortion.htm [accessed 28th
October 2005]
Competing interests:
None declared
Competing interests: No competing interests
I find it surprising, perhaps ironic, that the author makes his case
for the importance of evdence based approaches to bioethics on the basis
of two well worn anecdotes of when theory was not borne out in a research
study. That hypothesis turn out to be wrong is nothing new nor nothing to
be particularly ashamed about. It is how science works. It also does not
justify evidence based approaches to ethics.
Neither example cited is logically related to the claims the author
wishes to make as they involve examples of when physiological hypothesis
were not confirmed in a randomized trial. These are scarcely examples of
overturning normative theory, nor do these points establish the inadequacy
of normative thinking.
One would expect that the warrant for the need for an evidence based
approach in bioethics would come from at least a systematic review of such
occasions when normative theory employed "unfounded assumptions about
human behaviour". Furthermore, the examples we are to believe provide
convincing examples of when evidence based approaches are of benefit and
alter normative perspectives are also not from rigorous systematic
reviews.There is neither quantitative information on the magnitude of the
outcome measures, nor is information provided on the uncertainty around
these measures. Furthermore, they are relatively small samples and we know
nothing of their socio-cultural background to determine whether the
population is like any a reader woukd know.
Given that the examples used to make the case have low evidentiary
status in the evidence based hierarchy how are we to be entirely persuaded
of the necessity of the transformation in thinking the author recommends.
The relationship between ethics and evidence is complex and much more
nuanced than what we have presented here. The author unquestioningly
subscribes to a vision of evidence in health care that is deeply
problematic and his account of the relationship surprisingly one sided. At
no point does the author question the role of epidemiology in the creation
of evidence or probe deeply into the problems this vision of evidence
creates.
There are multiple examples of misleading and harmful evidence, and
to be anecdotal in kind, one can think of the recent experience of cox-2
inhibitors for pain and arthritis related conditions and the use of
spironolactone for heart failure. In both instances, clinicians in good
conscience and in the spirit of evidence based medicine prescribed
medications that were, in sum harmful, to populations. (but only if you
believed the observational evidence !)
For those seeking a more reflective account of the relationship
between evidence-based medicine and ethics I recommend: John Worral's
paper What evidence in evidence based medicine? available on line from the
London School of Economics at
http://www.lse.ac.uk/collections/CPNSS/pdf/pdfcaus/CTR01-02.pdf
Competing interests:
None declared
Competing interests: No competing interests
What seems to be common among 'evidence based' approaches to decision
making is not only the adherence to epidemiological methods, but the
exaggerated division between the empirical world of "facts" and the social
world of intuitions, habits, and values. The evidence based medicine
literature certainly endorses this division in its differentiation between
evidence based medicine and the "traditional" medicine that it wants to
replace. In "Towards Evidence Based Bioethics", Halpern similarly makes
an unapologetic equation of empirical evidence with "reality" and ethical
theories with rigid values and other subjective habits of thought in his
comparison of evidence based and "traditional" bioethics. A better
understanding of how empirical research can enrich bioethical inquiry
requires disavowal of such polemics, as the fact/value distinction does
not capture the complex relationship between empirical analysis, moral
discourse, and truth/reality or right action.
Evidence based approaches are notably silent on the values and
judgments that go into empirical analysis and research, from designing the
study to interpreting the data and applying it to patient care. The very
name "evidence based" suggests that the evidence somehow speaks, guides,
and decides. Evidence is in no way "given" and must undergo the social
processes of production, interpretation, evaluation, and application
before it can ground any decision.
Just as empirical analysis is value-laden, bioethics has never been
devoid of empirical consideration. Halpern wrongly characterizes
theoretical bioethics as being comprised entirely of intuitions and
perceptions, when in fact empirical content has always informed ethical
deliberation: whether to determine the actual or probable consequences of
actions for consequentialist reasoning or to specify the norms of
deontological consideration.
Bioethics has a short history of drawing on empirical research,
usually in the form of surveys or in-depth interviews that gauge patients'
or clinicians' attitudes or behaviours, in order to inform moral
decisionmaking. The qualitative, ethnographic, and phenomenological
methods typically undertaken in "empirical ethics" are ranked low on the
evidence based hierarchy of knowledge, which holds population based and
statistically derived clinical evidence to be most reliable and valuable.
The limits that evidence based approaches put on current research in
empirical ethics deserves further attention and discussion regarding what
kind of evidence informs bioethics.1
1 For further reading, see Goldenberg MJ. Evidence based ethics? On
evidence based practice and the 'empirical turn' from normative bioethics.
BMC Medical Ethics, in press.
Competing interests:
None declared
Competing interests: No competing interests
Potter, who coined the word “bioethics” in 1970, intended it to have
a much
broader meaning than the current narrow sense of “medical ethics”.1 The
scope
of bioethics should be extended to include a land ethic, a wildlife ethic,
a
population ethic, a consumption ethic, an urban ethic, an international
ethic, a
geriatric ethic, and so on as Potter wished. In applying bioethics to a
wide field
Potter intended bioethics to be based on a science of survival.
Evidence based medicine supplies evidence which should direct policy in a
wide
social field and not be confined to medical practice. Evidence based
medicine
tells us that smoking and obesity cause disability and death.
It is only bioethically right that physicians do not smoke and keep
themselves
slim. And it is also bioethically right that physicians tell patients
that they
should accept the responsibility that comes with the bioethics which tells
them
that they should not smoke and should keep themselves slim. It is only
bioethically right that physicians tell their patients that the society
and the
environment that is causing them to smoke and to overconsume and not take
exercise is their political and bioethical responsibility and only they
can change
the politics and thereby the bioethics.
1 Potter VR. Bioethics: The science of survival. Perspect. Biol. Med.
14(1):
1970,127–53. Quoted in “From the Editor’s Desk”, Perspect. Biol. Med,
volume
45, number 1 (winter 2002), 156.
Competing interests:
None declared
Competing interests: No competing interests
Scott Halpern is quite correct in his call for evidence based
bioethics, that theoretical concerns should be tempered with empirical
research. As he states "Bioethical theory often rests on unproved
assumptions about human behaviour". If Kant was working on an A&E ward,
blood transfusions might not take place for fear that the physician had
breached the autonomy of the donor. Speaking as a philosopher we do need
empirical research to inform our moral world-view, and I look forward to
such research. Physicians and Philosophers should be debating each other.
The problem is that debates between physicians and philosophers do not
take place that often, that last truly great debate I know of was on
haematology. It was between Dr.Harvey and Mr.Descartes on the circulation
of the blood in 1664.
Competing interests:
None declared
Competing interests: No competing interests
Commentary: Towards Evidence-Based Bioethics
The debate on Bioethics in Biomedicine is becoming more heated by the
day.
S. D. Halpern (from the Center of Clinical Epidemiology and Biostatistics
of the University of Pennsylvania) recently suggested the necessity of
Evidence-Based Bioethics (1). Medical Bioethics seems important also to
reduce the socio-economical costs of medical care, while reducing some
unavoidable waste. The Author quotes the examples of paid “volunteers” and
“reasonable person standard”.
What does “evidence-based” mean?
The term “evidence–based”, referred to medical evaluation, is a matter of
controversial debate. Since some authors are inclined to relate it to
“efficacy”, the discussion continues. Throughout its history medicine’s
primary goal has been effectiveness.
In Bioethics the term “Evidence-Based” could be further misinterpreted to
the point that anything “effective” (e.g. therapeutically) is considered
“ipso facto” ethically grounded. This interpretation is unacceptable. Some
paragraphs of the “Hammurabi Code” (about 1850 b. C.) are dedicated to
specific criteria justifying penalties for medical doctors in cases of
therapeutic failure. Is this an example of “Evidence-Based Medicine”? Is
it also “Evidence-Based Bioethics”?
Another matter is whether “evidence-based” should be interpreted
considering both the essential traits of Homo sapiens as humankind and the
fundamental and evident values characterizing human nature.
For a very long time western philosophy has been meditating on the
difference between “evidence” and “problematic nature” of uncertainty.
Human freedom has been classified as “evident”, not deterministic in its
thoughts and actions. Western philosophy raised this question: what is the
value of thoughts and dialogues among human beings governed by relevant
laws? Ilya Prigogine defines this freedom as “The end of certainty” (2).
Halpern concludes his brief overview by summarising his views in
three final summary points. They seem unclear, in particular when he
openly refers to “synergistically”. In our opinion this is a subtly
utilitarian approach, disguised as a balanced final consideration. Some
points of view, such as those of theologians, are systematically excluded.
Rino Fisichella is Chancellor of the Pontifical Lateran University,
Chaplain of the Italian Parliament, Secretary of the Bishop’s Commission
for the Doctrine of the Faith, Councillor of the Congregation for the
Doctrine of the Faith an Member of the Congregation for the Cases of
Saints. He has been Auxiliary Bishop of Rome. Bishop Fisichella is a key
decision-maker in drafting several documents of the Holy See. In a recent
conference he stated:
“Therefore nature needs mankind to reveal its inner self. And what is
so extraordinary is that in perceiving this, man also discover that he is,
at the same time, both a product of nature and its ultimate goal. This
however does not imply that man can do with nature as he pleases (…). Man
cannot make progress by destroying himself or playing with human nature;
this is not in line with nature which tends towards man, nor with human
nature which uses its own development to regenerate itself. Dignity of the
human nature inevitably falls within this context. Since human nature is
not a simple mass of cells and tissues, organs and functions, but an
indissoluble union of the body and the spirit, it can never be governed
solely by biological laws without risking its very own existence. Science
and technology share not only a great responsibility towards human nature,
but have the ethical duty to serve man and his indefeasible rights. Any
other way, whether feasible or not, would be coercive with regard to that
same human nature that it is intended to promote (…). Ethical principles
do not limit man's attitude to scientific research, nor his longing desire
to overcome his own discoveries; on the contrary, ethics outlines a space
of action within which man and his nature can live in harmony” (3).
We believe that Bishop Fisichella’s statements should be considered
within the present debate on Medical Bioethics.
For many scientists and medical doctors Bioethics originated in 1970 (4)
and EBM in 1992 (5) . Some hints of “Evidence-Based Bioethics” can
already be found in the Bible, possibly starting from Solomon’s judgement.
Carlo Petrini
Bioethics Unit
Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute
Enrico Alleva
Section of Behavioural Neurosciences
Dipartimento di Biologia cellulare e Neuroscienze
Istituto Superiore di Sanità,
Viale Regina Elena, 299,
I-00161 Rome, Italy
---------------
1. Halpern Scott D. Towards evidence based bioethics. British Medical
Journal; 2005 (15 Oct.): 331 (7521): 901-903.
2. Prigogine I. The end of certainty. New York: The Free Press, 1977.
3. Fisichella R. Ma il mistero non umilia l'uomo che cerca. Avvenire,
2005 (Oct. 13); 38 (244): 31 (Debate “Human nature and biotechnolgies”,
with Francis Fukuyama and Giuliano Ferrara. Rome, October 10, 2005).
4. Potter V. R. Bioethics: the science of survival. Perspectives in
biology and medicine,1970; 14 (1): 127-153. In 1971 the paper was
published as first chapter of the book “Bioethics, bridge to the future”
(Englewood Cliffs, New Jersey, Prentice-Hall Inc, 205 p.).
5. Evidence-Based Medicine Working Group. Evidence-based medicine: a
new approach to teaching the practice of medicine. JAMA, 1992 (Nov. 4);
268 (17): 2420-2425.
Competing interests:
None declared
Competing interests: No competing interests