Recently the Journal of Medical Ethics published an article by L
Bovens, from the London School of Economics and Political Science,
Department of Philosophy, Logic and Scientific Method. Under a banner
REPRODUCTIVE ETHICS, the article was entitled The rhythm method and
embryonic death. The gist of the article was that the pro-life movement,
and particularly Catholics, are responsible for the deaths...
Recently the Journal of Medical Ethics published an article by L
Bovens, from the London School of Economics and Political Science,
Department of Philosophy, Logic and Scientific Method. Under a banner
REPRODUCTIVE ETHICS, the article was entitled The rhythm method and
embryonic death. The gist of the article was that the pro-life movement,
and particularly Catholics, are responsible for the deaths of “millions of
unborn children” by advocating the Rhythm Method.
The route which Bovens took to arrive at this conclusion offers a
circuitous, dual lane and very bumpy ride. Circuitous because it went by
way of three assumptions, dual lane because he argued from “science” and
“philosophy” , and bumpy because even the basic premise was full of pot-holes.
“The first assumption is that there are a great number of conceptions
that never result in missed menses. There are estimates that only 50% of
conceptions actually lead to pregnancies.” Bovens does not favour us with
the source of these estimates, but we do know that a study conducted at
the Royal Women’s Hospital in Melbourne in 1985/6, debunked this myth.
Women who were hoping for a pregnancy were asked to submit to regular
blood tests from ovulation to the onset of menstruation to establish how
many pregnancies were ending in miscarriage before menses was even missed.
The figure was zero.
The second assumption is that the Rhythm Method fails when acts of
intercourse close to either end of the “prescribed abstinence period”
result in a pregnancy. Therefore, being at the limits of the window of
fertility, these conceptions must be less viable and hence more likely to
die. Bovens here demonstrates an appalling lack of knowledge of
reproductive physiology. But more of that in a moment.
His third assumption, which he says himself “is not backed by
empirical evidence”, is that these conceptions, resulting from an “old”
ovum or an “old” sperm, are then trying to “implant in a uterine wall that
is not at its peak of receptivity”. This again denies the facts of the
matter.
Briefly – conception can only result from an act of intercourse which
occurs when a woman’s body is receptive to sperm. This is for just a few
days in each cycle when her cervix is open and is secreting mucus which
can sustain sperm for more than the brief time that they otherwise live
after ejaculation. This action of the cervix is triggered by rising
oestrogen levels produced by the developing follicle in the ovary where
the ovum is maturing.
The combined fertility of the couple culminates with the rupture of
the follicle and the release of the mature ovum at ovulation. The ovum,
once released, lives for a maximum of 24 hours. It is only during this
time that it is available to be fertilised. If conception does not occur
the ovum dies and disintegrates, and the cervix becomes impenetrable to
sperm.
One function of the cervical mucus is to screen out defective sperm,
or those that are “too old”, so that they never reach the waiting ovum.
For verification of these scientific facts, see the published findings of
Professor James Brown of Australia (hormones) and Professor Erik Odeblad
of Sweden (cervical function).
Once conception occurs, the zygote travels down the fallopian tube to
arrive in the uterus approximately 6 days later. Implantation begins, and
is completed by 12 days after conception. The endometrium (lining of the
uterus), which was built up in response to the rising oestrogen levels
(the proliferative phase of the endometrium) is then made ready for
implantation by progesterone, which is secreted by the corpus luteum (the
remains of the follicle) during the luteal phase of the cycle (the
secretory phase of the endometrium). The zygote arrives in the uterus at
just the right time for implantation, regardless of when the act of
intercourse occurred which caused the conception, or even when in the
woman’s cycle the ovulation occurred.
Thus, Bovens’ detours via these three assumptions are all found to be
dead ends. One lane of his dual-lane carriageway is found to be
impassable – his “science” is flawed. The other lane – philosophy – goes
by way of direct action (presumably as opposed to indirect action) and
what he terms action/omission doctrine, though he says “this is not the
place to turn to this discussion”.
Sounds to me as though the carriage has ground to a halt – maybe the
horse has run out of oats. And we must be travelling by horse and
carriage, because the really glaring flaw in his argument, is that no-body
now seriously advocates the Rhythm Method, nor has done for at least forty
years. It was in the early 1950s that research began into a
scientifically-based, clinical-proven alternative. The Billings Ovulation
Method of natural fertility regulation, has a success rate, for avoiding
pregnancy, equal to any chemical or surgical method, and a success rate
for achieving pregnancy which is substantially better than any
interventionist technique currently available.
We would like to thank the authors and editors of the JME’s mini-
symposium on the Olivieri case for continuing and extending the dialogue
about this important challenge to the North American bioethics community.
This mini-symposium is of special interest to us as members of the
Canadian Bioethics Society’s “Working Group on Employment Standards for
Bioethics.” We are members of this Workin...
We would like to thank the authors and editors of the JME’s mini-
symposium on the Olivieri case for continuing and extending the dialogue
about this important challenge to the North American bioethics community.
This mini-symposium is of special interest to us as members of the
Canadian Bioethics Society’s “Working Group on Employment Standards for
Bioethics.” We are members of this Working Group precisely because we
believe that most of us in the Canadian bioethics community ought to do
more to respond to situations such as the Olivieri situation. We welcome
the opportunity to continue to learn from that situation and to move
forward to strengthen our Canadian community of bioethicists.
Our Working Group, as a formal body, originated at the 1999 Annual
Meeting of the Canadian Bioethics Society (CBS). At that meeting, a motion
was passed establishing a “Working Group on Employment Standards for
Bioethics.” The purpose of the Working Group was, and continues to be, to
examine the issues of ethicists’ roles and responsibilities and the
environment in which ethicists, particularly those practicing in a non-
tenured environment, work. We have been endeavouring to grapple with a
number of the kinds of issues raised in the mini-symposium, including
accountability on the part of both bioethicists and the organizations
employing them, standards of practice in bioethics, protection for
whistleblowers, and how to respond to problems inherent in the moral
climate of the organizations in which we work.
Among our undertakings to date:
• A Draft Discussion Paper, "Working Conditions for Bioethics in Canada;"
• A “Model Code of Ethics for Bioethics;”
• Workshops, panels, or discussions at the CBS’s Annual Meetings in 1999,
2000, 2001, and 2002; and
• An essay prize “to encourage junior scholars to engage in scholarly work
related to working conditions in bioethics; professionalism in or the
professionalization of bioethics; or the social role of bioethics.”
The Working Group’s current works-in-progress include:
• A Qualitative Study of Conflicts of Interest Among Bioethicists;
• A working paper on various models of workplace dispute resolution;
• A “model contract” for clinical ethics consultants;
• A framework for a peer support network.
A record of our work on these issues can be found on the CBS’s website, at
http://www.bioethics.ca/
We know that no one aspect of our work to date constitutes a panacea.
It’s likely that no draft document or peer support network could have
averted the Olivieri debacle. But we remain committed to the ideal that
this work is of value, and that ongoing discussion and open and frank self
-examination is crucial.
The JME’s mini-symposium reminds us that we have a great deal still
to do, and that this kind of work is urgently needed. We can ignore all of
these matters (since crises happen but rarely in any individual’s work-
life) but we do so at our peril. The publication of the JME mini-symposium
is a milestone – a wake up call for all of us working in bioethics. We
applaud the JME’s attention to this crucial issue, and invite the
bioethics community and its many stakeholders to join us in our continuing
attempts to grapple with this difficult issue in a constructive way.
Finally, we recognize the need for healing in the bioethics
community, and suggest that this healing will require collegiality and
constructive moves in the direction of reconciliation. Only in this way
will bioethics be strengthened as a community, and left more capable of
responding to cases like the Olivieri case in the future.
I would like to thank Dr. Ajayi for his/her views about moral
principles and taboos in clinical research in West Africa. The research
setting he has described is similar to the setting where I work. However,
much as I agree with some of his views, I disagree with his assertions
that moral principles are relative to local contexts and that ethical
principles must relate intimately with the norms of...
I would like to thank Dr. Ajayi for his/her views about moral
principles and taboos in clinical research in West Africa. The research
setting he has described is similar to the setting where I work. However,
much as I agree with some of his views, I disagree with his assertions
that moral principles are relative to local contexts and that ethical
principles must relate intimately with the norms of the local population.
In my view, moral principles are universal principles which must be
applied in space and time. For instance, the principle of respect for
persons calls on researchers to respect research participants and treat
them as ends in themselves and not merely as means to fulfil their
ends. This principle recognizes the fact that human beings are autonomous
beings and have dignity. In this regard, respect for human dignity is a
universal concept and a fundamental right for all human beings in space
and time. And when it comes to clinical research, all human subjects must
give their informed consent to participate regardless of where and when
they live. Researchers can not override informed consent in a specific
situation just because individuals in that society are ignorant of their
autonomy and worth or have a different concept of personhood. Researchers
have a duty to ensure that human subjects in all settings know that they
are autonomous beings and have dignity. They must make sure that they are
well informed about the ethics of clinical research and make informed
decisions about their participation in clinical research.
In cases where the universal ethical principles conflict with local
norms,the universal ethical principles must rule over local norms. The
principle of non-contradiction must be applied to the universal ethical
principles - "they can not be A and B in the same world at the same time".
Unless one does not consider them as universal ethical principles and
guidelines. In addition to this, any misconceptions about clinical
research in the local context must be cleared out. As an African myself, I
do feel that most of the taboos and norms we have in Africa are useless.
For instance, in some African settings, most women have no power to decide
to participate in clinical research; instead their male partners decide
for them. If the male partners refuse to let them participate, they do not
enrol in research. Yet the principle of respect for persons calls for the
voluntary consent of each individual research subject. So, do researchers
have to respect husbands' wishes which influence individual female
participants' decisions? Or should they let the female potential
participants decide on their own? Of whose immediate benefit is the
clinical research? In my view, respecting husbands' wishes is incompatible
with voluntary consent. There are also alot of misconceptions about blood
taking in some African settings, and clinical studies that involve blood
taking are often not welcome. These are misconceptions that have to be
cleared out by researchers. Researchers do not have to respect such
misconceptions when the benefits from such research might outweigh the
risks of not doing it. That said, it would be negligent for researchers to
deny clinical research that could benefit the population because it would
be a taboo or against societal norms to carry out such a research in the
setting.
Finally, I would rather urge researchers to abide by the ethical
regulations and guidelines (as stipulated in the Nuremburg Code,
Declaration of Helsinki, CIOMS etc) when conducting research in any
setting. Those regulations are fundamental and universal - they apply in
any space and time. Otherwise, we will end up having different ethical
guidelines for the same human subjects for different countries. And yet
human beings are all one.
Re: Ethical problems arising in evidencebased complementary and alternative medicine
Edzard Ernst, Michael H. Cohen, Julie Stone
Mr McIntyre [1] rightly states that, in the UK, initiatives are underway
to regulate acupuncturists and herbalists. At the time of writing this
letter, a draft document is circulating. At the time of writing the actual
article (about one year ago), these initiat...
Re: Ethical problems arising in evidencebased complementary and alternative medicine
Edzard Ernst, Michael H. Cohen, Julie Stone
Mr McIntyre [1] rightly states that, in the UK, initiatives are underway
to regulate acupuncturists and herbalists. At the time of writing this
letter, a draft document is circulating. At the time of writing the actual
article (about one year ago), these initiatives had barely started and
certainly had not produced anything tangible. Regulation of UK
acupuncturists and herbalists may be in place in about 2 – 3 years (my
estimation). For the many other CAM providers (from aromatherapists to
yoga teachers), no such initiatives exist. My main point is that, except
for chiropractors and osteopaths, there is no statutory regulation at
present. This also means that today anyone in the UK, irrespective of
training or education, can call themselves an acupuncturist or herbalist.
Thus I truly don’t see the “glaring omission”. In terms of integrating
“orthodox and CAM for the benefit of millions”, McIntyre seems to forget
that evidence has to come before integration. In the case of the
therapeutic approach of UK traditional herbalism, I know of not a single
study that would constitute acceptable proof of efficacy. I’m also not
sure whether “the UK leads the world in the development of CAM” – it would
be nice but I do detect a bit of wishful thinking in McIntyre’s words.
References
(1) McIntyre MJ. Positive developments in CAM in the UK [electronic response to JME Advanced Publication: Ernst et al. Ethical problems arising in evidencebased complementary and alternative medicine] jmedethics.com 2004http://jme.bmjjournals.com/cgi/eletters/28/2/DC1#122
This is an interesting hypothesis, but the author has
lost me in the second paragraph by saying that "rhythm" is the only method
approved by the Catholic Church. Whether Bovins has confused rhythm with
NFP or presumed the two methods are one and the same, it is an inexcusable
error in a scientific report.
Rhythm is using a calendar, assuming the "standard" 28-day cycle, to
guesstimate when ovula...
This is an interesting hypothesis, but the author has
lost me in the second paragraph by saying that "rhythm" is the only method
approved by the Catholic Church. Whether Bovins has confused rhythm with
NFP or presumed the two methods are one and the same, it is an inexcusable
error in a scientific report.
Rhythm is using a calendar, assuming the "standard" 28-day cycle, to
guesstimate when ovulation occurs. It is highly fallible, most obviously
because very few women actually experience the "textbook" 28-day model for
the menstrual cycle promoted as part of the rhythm method.
Natural Family Planning, or NFP, on the other hand, depends on
recognizing certain physical symptoms of fertility and approaching
ovulation -- changes in quantity and quality of cervical mucus discharge,
the shape, placement and consistency of the cervix itself, and a few more
complicated techniques like basal body temperature. It can be used to try
to achieve or avoid pregnancy.
NFP is approved by the Church for use in extraordinary circumstances
(couple abstain from intercourse during the time a woman is fertile)
because it does not interfere with a woman's natural cycles, because it is
consistent with a respect for life, and (this is very important!) because
it shows respect for the nature of the marital sexual union as an analogy
of the mystical union between Christ and His Church. (People think the
Church is anti-sex.... ahhhh, if only they knew!)
NFP is proven to be more than 98% effective, more effective than any
other contraceptive measure. Of course, it involves the inconvenience of
paying attention to fertility symptoms and of a degree of self-denial, but
it is extremely effective. Moreover, every couple I know who have
practiced NFP are enthusiastic advocates of it -- yes, that includes the
men, who say that periods of abstinence enrich their elationships with
their wives and make the times of intimacy more gratifying.
Oh -- some studies indicate that NFP couples actually engage in
sexual intercourse more times per month than non-NFP couples.
Finally, I am not comfortable with the promotion of "assumptions"
without a presentation of the basis from which said assumptions occur. One
can easily dismiss the premise that rhythm leads to more deaths in
consequence: embryonic deaths can occur from flaws resulting from
unhealthy ovum or sperm (ostensibly because of "old" sperm left in the
fallopian tube to fertilize the ovum), but they can also occur because of
biochemical hostilities brought about by mechanical and/or chemical
impositions of artificial birth control methods. However, the thing
Catholic consider is that embryonic deaths due to lack of viability is not
the result of a hostile act against life in general or the specific
conception. This is of paramount importance.
I recommend Bovens and anyone else interested in the subject read
Kippley and Kippley, The Art of Natural Family Planning, and the Papal
Encyclicals: Pope Paul VI's Humanae Vitae and John Paul II's Evangelium
Vitae: John Paul II's work on Theology of the Body (synthesized for easier
mental consumption by Christopher West) is also seminal.
Professor F. Baylis in her symposium on the ‘Olivieri debacle’ examines a highly debated controversy.[1]
I
would like to look at the developments from a different angle. Olivieri
debacle, to me, is an example of a crisis where academia, researchers and
the bioethicists worked in unison for a common noble cause.
The situation that the author tries to portray as "a proud moment in
time...
Professor F. Baylis in her symposium on the ‘Olivieri debacle’ examines a highly debated controversy.[1]
I
would like to look at the developments from a different angle. Olivieri
debacle, to me, is an example of a crisis where academia, researchers and
the bioethicists worked in unison for a common noble cause.
The situation that the author tries to portray as "a proud moment in
time for Canadian bioethics" may not look very proud to everyone as
evidenced in the editor’s note about the "'perils of heroism' which stem
from the narcissistic striving for personal glory".[2] Earlier discourses
in this subject have always reminded me that the researchers should be
very careful in signing research agreements with sponsors. Subsequent
developments in this case have undoubtedly shown that the bioethics
community did rise to the occasion and act towards placing in position
suitable mechanisms to safeguard researchers from signing research
contracts with objectionable clauses.[3]
Mary Rowel’s responses to the symposium connote that her opinions
were distorted.[4] The author states that Ms Rowell initially refused to
write an article for the symposium and later her article "prompted her to
write about her experiences".[5] I personally hold that individuals should
not be compelled to speak aloud or write on something that they do not
want to. Many had provided directions to prevent such disasters in future [6,7] and even the supporters of whistle-blowers have presented well
balanced views on this issue.[8] Being a student and researcher in
bioethics, I would like to hear more future directions from the learned
teachers, including the author.
The unhealthy influence of industry on biomedical research and the
lassitude and intentional inactivity of universities and academic
institutions to support researchers with genuine causes are really
worrisome. More worrisome is the creation of any schism within the
academic community in an era where collective action can do a lot to
safeguard the scientific and ethical principles of biomedical research.
As a bioethics student from a non-industrialized country, I feel that the
bioethics community in Canada has acted realizing the full implications of
the case and worked towards developing safety mechanisms to safeguard from
similar disasters in future. In India, we suffered a lot due to the
policy of ‘divide and rule’ during the historic independent struggles and
learned the lesson to stand together in moments of crisis. The Olivieri
debacle once again showed the need for everyone including academia,
researchers and the bioethicists working together for a common cause.
References
1. Baylis F. The Olivieri debacle: where were the heroes of bioethics?
Journal of Medical Ethics 2004; 30: 44-49.
2. Savulescu J. Editor’s note: How can we make a difference? The
perils of heroism. Journal of Medical Ethics 2004; 30:52.
3. Ferris L.E, Singer P.A, Naylor C.D. Better governance in academic
health sciences centres: moving beyond the Olivieri/ Apotex affair in
Toronto. Journal of Medical Ethics 2004; 30: 25-29.
4. Rowell M. The Olivieri debacle: where were the heroes of
bioethics? A reply. Journal of Medical Ethics 2004; 30:50.
5. Baylis F. Responses to Mary Rowell. Journal of Medical Ethics
2004; 30:51-52.
6. Schafer A. Biomedical conflicts of interest: a defence of the
sequestration thesis - learning from the cases of Nancy Olivieri and David
Healy. Journal of Medical Ethics 2004; 30: 8-24.
7. Du Val G. Institutional ethics review of clinical study
agreements. Journal of Medical Ethics 2004; 30: 30-34.
8. Rhodes R, Strain JJ. Whistle blowing in academic medicine. Journal
of Medical Ethics 2004; 35-39 & Faunce T, Bolsin S, Chan W-P.
Supporting whistle blowers in academic medicine: training and respecting
courage of professional conscience. Journal of Medical Ethics 2004;30: 40
-43.
The recommendations suggested by C Cowley (Polemic: five proposals
for a medical school admission policy
J Med Ethics 2006; 32: 491-494) although appearing thoughly insightful
purely represent another attempt by another medical educationalist who
spends more time thinking about training this great nations future doctors
than training them.
Concerning his first recommendation the fanciful notion...
The recommendations suggested by C Cowley (Polemic: five proposals
for a medical school admission policy
J Med Ethics 2006; 32: 491-494) although appearing thoughly insightful
purely represent another attempt by another medical educationalist who
spends more time thinking about training this great nations future doctors
than training them.
Concerning his first recommendation the fanciful notion that making a
humanities subject a stringent requirement so as to benefit the medical
student and broaden his experience is ill-advised. Although most medical students
study pure sciences they do possess a grounding through other avenues of
learning towards subjects that do not necessarily encompass the above.
Just have a conversation with us. One shall rapidly discover to ones
surpise that we are not the stereotypical ancient social neanderthals as
modern educationalists make us out to be.
Concering the second notion about english literature and its supposed
creative benefits to prevent us from stereotyping patients can he just re-
read what he wrote please? On the on hand he mentions that a scientific
mind set of stereotyping symptoms and recognising patterns progresses
science. But on the other he insists that such an education void of
literature stimulates such a though process which he does not consider
wholesome. So what is it please? Where is the balance? Concerning
creativity it is somewhat bewildering that such as academic in the twenty
first century would assume that such a step would improve our abilities to
think creatively. In the age of the iPod and music downloads and
everything internet based medicine no longer attracts the same stereotype
that exists during his generation. Times have changed without the need to
tamper. Also have any long term prospective and retrospective studies been
done on this? In an age of evidence based medicine it is ridiculous to
wish to redesign the entire undergraduate medical process without
conducting large scale studies from sixth form through to consultancy and
then retirement to assess this.
Concerning the third point a minimum age of twenty three would be
extremely disadvantageous to women. For women to complete undergraduate
medical education by thirty a lesser percentage would become consultants
in competitive specialities (when we are trying so hard to ensure that the
tables are even as that is what MMC is supposed to be about). One is
essentially saying that the longer you delay completion of undergraduate
medical education the less women are to enter certain specialties are
other factors outside of medicine being to predominate (families). What
about the divorce rate?
Concerning the fourth point when someone comes in with an aortic
dissection singing them a lullaby or reading them a novel is not going to
work. Hard science and its correct application saves the day. We learn
less and less science and more and more explanatory things which is not
making us better doctors! Shipman probably had great communication skills!
Most graduates who comment that they benefitted from medicine more as
a graduate are talking from a skewed perspective because few would have
had the intellectual aptitude and motivation to succeed in medicine
straight from school unlike the thousands of school leavers who obviously
do.
Medicine is only crumbling because educationalists constantly try and
mend a wheel that is not broken! We constantly attack the school leaver.
To enter the competitive world that is medicine straight from school and
possess the strong motivation and drive to not only pass but succeed and
become some of the worlds most talented humans is to congratulated. Most
so called enlightened graduates did not possess that at their age that is
why they are only doing medicine now and not then. To insult the school
leaver as an immature poorly shaped and naive poor comminicator is
pathetic. This is especially so when most have parents who are doctors and
so since young they have had a thorough comprehensive idea what medicine
is about. They are not naive.
I have read the recent theme issue on evidence based medicine and the
various articles have raised some disquiet, mainly because they seem to be
applying a concept of evidence based practice which assumes centralised
imposition of rules, rather than the generally accepted concept of seeking
and analysing the best evidence, using clinical judgment and adapting
these to the patients wishes,
I have read the recent theme issue on evidence based medicine and the
various articles have raised some disquiet, mainly because they seem to be
applying a concept of evidence based practice which assumes centralised
imposition of rules, rather than the generally accepted concept of seeking
and analysing the best evidence, using clinical judgment and adapting
these to the patients wishes,
Most authors appear to have made the assumption of medical
epistemology being an absolute form of knowledge, and attack EBP (Evidence
based practice) as providing imperfect knowledge, I was expecting a
variant of the ontological argument to emerge but thankfully the Cartesian
absolutism did not progress.
Medical diagnosis is similarly treated as an absolute – though we regard
ourselves as “knowing” a diagnosis it is not the meaning of the verb “to
know” as applied by the majority of your authors. “Knowing” to a medical
practitioner, is (or should be) a probabilistic assumption. “Knowing” a
diagnosis means we have matched in our memories a set of facts with what
we observe, or clinically judged to be present, it is a label for
classification and prognosticating it is not an absolute reality which
most of your authors seemed to have assumed. “Knowing” a treatment
similarly means we have matched a label (diagnosis) with past memories it
is similarly subject to weaknesses of our memory systems, and our
emotions. “Knowing” means that the assertion is highly probable not an
absolute.
While EBP has been hijacked by governments, government sponsored disease
lobby groups, and even the pharmaceutical industry and so called
guidelines produced it is inevitable that they will reflect the prejudices
and beliefs of the writer(s), and may reflect the extent of knowledge up
to the time the editor sends the final to the printer, that this may be
several years before the reader comes to apply it means that, though
evidence based, it is no longer current evidence. That this process has
occurred is irrelevant to the process of evidence based practice as the
principle of EBP means the practitioner will assess the guidelines as they
would any other set of information. A person considering the use of a
guideline should, as a first step see when it was published, and what
evidence is quoted. If there is no evidence base quoted throw the damn
thing away.
Another major concern was the expressed belief of some authors in the
immutability of knowledge. Though we have an agreed set of diagnostic
labels their application varies throughout world, we cannot even reach
consensus on the diagnosis of death (one of the epidemiologists binary
states) – our knowledge will always be imperfect and subjective. The
application of EBP (it is a process not a philosophy) aims to reduce the
subjectivity of externally acquired knowledge (i.e. what we do not observe
ourselves) because we recognise the imperfections of the system which
generates that knowledge. Poor experimental design, fraud, selective
publication, omission of key data to push a product, poor statistical
technique all act to mislead us when we are discussing options with our
patients and what the Cochrane collaboration, and meta analysis, and
systematic review do is hopefully weed out the misleading data. Of course
any systematic review will be subjective – we can reduce subjectivity( or
social values) not abolish it.
As individual practitioners our response to our patients and their
diagnoses becomes coloured by our experiences, we are animals we wish to
avoid pain both physical and emotional, one poor outcome may colour our
advice to the detriment of the patient – it is because of this we need a
source of up to date clinical evidence even though it will always be
imperfect and incomplete. In the past when medicine was less dynamic
textbooks sufficed as this source of evidence but reliance on textbooks in
our computerised society is decreasingly valid.
The application of EBP to quality improvement is also a process,
people who do not realise the realities of dealing with autonomous human
beings may assume that failing to prescribe what is suggested by current
evidence reflects poor practice – the only person who can make that
judgment is the practitioner – it is they who negotiates the treatment
plan, it is they to whom the patient expresses their fears beliefs and
prejudices and no one else can be party to that special arrangement. The
application of EBP in quality improvement is flagging deviation from
evidence and asking the practitioner to reflect on why they reached that
course of action.
Evidence based practice is a tool, just as a computer is a tool. Neither
represent a replacement of clinical judgment, or clinical skill and that
they are misused by the ignorant to try to alter our behaviour is not
valid grounds for rejection. Evidence based practice simply a further
change in the practice of medicine that our successors will master over
time, and some of us are trying to master now.
My apologies for the brevity of the arguments but this is merely a letter.
Sheard et al. are right to raise awareness regarding the practicality
of the ‘approvals process’ for non-commercial clinical trials and the
duplicative application process that often involves research governance,
ethics, the research sponsor and, for trials involving medicinal products,
the MHRA. This can indeed be a time-consuming and often frustrating
process. I would, however, like to respond to a num...
Sheard et al. are right to raise awareness regarding the practicality
of the ‘approvals process’ for non-commercial clinical trials and the
duplicative application process that often involves research governance,
ethics, the research sponsor and, for trials involving medicinal products,
the MHRA. This can indeed be a time-consuming and often frustrating
process. I would, however, like to respond to a number of issues raised in
the section of the paper devoted to research ethics and particularly so,
as the application was considered by the Northern and Yorkshire Multi-
Centre Research Ethics Committee. Indeed, some of the points raised are
now factually incorrect.
The Research Ethics process in the UK may not yet be streamlined to the
satisfaction of all aspects of clinical research but the Central Office
for Research Ethics Committees (COREC) continually strives to ensure that
problems with the system are identified and resolved; this,has led to
modifications to the national application form since its introduction in
2003. For example, it has been recognised that obtaining the signatures
of the Governor of a prison and a prison health care professional may
cause significant difficulties for an applicant and the requirement for
these signatories has now been removed from the latest version of the
application form.
The authors report that their application could only have been submitted
to one of only 4 MRECs nationally rather than to a Local REC which might
have been locally based. There are certain aspects of clinical research
such as research in prisons and phase 1 trials where ethics review is
undertaken by a limited number of RECs that have both the expertise and
experience of reviewing such trials. There are now 4 MRECs and 4 LRECs in
England and Wales that have the responsibility of reviewing prison
research and all have the option of having a link with a Prison Service
Area Psychologist.
The authors comment that the ethics process took 5 months from first
submission to gaining a favourable opinion. They fail to mention that RECs
are now legally obliged to provide an opinion within 60 days of receiving
and validating an application although this period does not include the
time that researchers may take to respond to issues raised by the
committee Nevertheless, on this occasion, given that the application was
submitted in February 2006 for the March meeting, that meant that once the
application had been considered by the MREC, the Committee and co-
ordinator had only 24 days to deal with associated administrative issues
and responses. Few committees in any system could consistently work to
such restrictive deadlines.
Within the ethics section of the paper, the authors comment that they had
assumed that they would have been able to apply for a Doctors’ and
Dentists’ Exemption certificate (DDX) for their trial and that the MREC
had stated that MHRA approval would be required for the study. Whilst this
is indeed true, I would argue strongly that this is not an ethics issue.
Certainly, RECs have a responsibility to ensure that researchers proposing
trials involving medicines (and medical devices) are aware of, and have in
place, the appropriate and relevant documents as required by law and by
the MHRA. The DDX scheme ceased to exist from 1st May 2004 (almost a year
prior to the researcher's ethics and MHRA submissions) when the Clinical
Trial Authorisation was introduced and subsumed all of the exemption
certificates including the DDX. The moral here therefore, and especially
for researchers proposing to undertake randomised clinical trials with
medicines – assume nothing!
Finally, the paper conveys weaknesses in the understanding of drug
development and the phases of trials and it is disappointing that these
were not identified and corrected during the refereeing procedure. For
example, phase 1 trials do not assess the efficacy of a new product (page
432) and may include trials of licensed medicines administered to
volunteers to gain additional clinical pharmacology data. Further, the
authors are wrong to assume that there can never be any significant
ethical and safety issues with trials of licensed medicines which is why
indeed, all trials are treated as equal in terms of ethical review and
risk assessment.
The paper by J Harris is well thought out and certainly
discusses one of the most difficult issues a doctor may
face; this includes not only breaking bad news but also
helping his/her patients with any ensuing decisions
regarding 'end of life decisions'.
As a paediatrician, one faces the additional difficulty
that one's patient is often unable to voice his/her wishes
or feelings. When faced with hav...
The paper by J Harris is well thought out and certainly
discusses one of the most difficult issues a doctor may
face; this includes not only breaking bad news but also
helping his/her patients with any ensuing decisions
regarding 'end of life decisions'.
As a paediatrician, one faces the additional difficulty
that one's patient is often unable to voice his/her wishes
or feelings. When faced with having to decide what to do
for their child ('to continue or not to'), parents are
often unable to come to a decision. Quite often during the
course of such lengthy discussions, one of the two parents
eventually asks: And what would you do, Doctor?
Up till now, that question remained a theoretical one for
myself. Being a parent now, this question would now carry
significantly more 'real' weight... How would I honestly
answer such a question??
Dear Editor,
Recently the Journal of Medical Ethics published an article by L Bovens, from the London School of Economics and Political Science, Department of Philosophy, Logic and Scientific Method. Under a banner REPRODUCTIVE ETHICS, the article was entitled The rhythm method and embryonic death. The gist of the article was that the pro-life movement, and particularly Catholics, are responsible for the deaths...
Dear Editor:
We would like to thank the authors and editors of the JME’s mini- symposium on the Olivieri case for continuing and extending the dialogue about this important challenge to the North American bioethics community.
This mini-symposium is of special interest to us as members of the Canadian Bioethics Society’s “Working Group on Employment Standards for Bioethics.” We are members of this Workin...
Dear Editor,
I would like to thank Dr. Ajayi for his/her views about moral principles and taboos in clinical research in West Africa. The research setting he has described is similar to the setting where I work. However, much as I agree with some of his views, I disagree with his assertions that moral principles are relative to local contexts and that ethical principles must relate intimately with the norms of...
Dear Editor
Re: Ethical problems arising in evidencebased complementary and alternative medicine Edzard Ernst, Michael H. Cohen, Julie Stone
Mr McIntyre [1] rightly states that, in the UK, initiatives are underway to regulate acupuncturists and herbalists. At the time of writing this letter, a draft document is circulating. At the time of writing the actual article (about one year ago), these initiat...
Dear Editor,
This is an interesting hypothesis, but the author has lost me in the second paragraph by saying that "rhythm" is the only method approved by the Catholic Church. Whether Bovins has confused rhythm with NFP or presumed the two methods are one and the same, it is an inexcusable error in a scientific report.
Rhythm is using a calendar, assuming the "standard" 28-day cycle, to guesstimate when ovula...
Dear Editor
Professor F. Baylis in her symposium on the ‘Olivieri debacle’ examines a highly debated controversy.[1]
I would like to look at the developments from a different angle. Olivieri debacle, to me, is an example of a crisis where academia, researchers and the bioethicists worked in unison for a common noble cause.
The situation that the author tries to portray as "a proud moment in time...
Dear Editor,
The recommendations suggested by C Cowley (Polemic: five proposals for a medical school admission policy J Med Ethics 2006; 32: 491-494) although appearing thoughly insightful purely represent another attempt by another medical educationalist who spends more time thinking about training this great nations future doctors than training them.
Concerning his first recommendation the fanciful notion...
Dear Editor
I have read the recent theme issue on evidence based medicine and the various articles have raised some disquiet, mainly because they seem to be applying a concept of evidence based practice which assumes centralised imposition of rules, rather than the generally accepted concept of seeking and analysing the best evidence, using clinical judgment and adapting these to the patients wishes,
Most...
Dear Editor,
Sheard et al. are right to raise awareness regarding the practicality of the ‘approvals process’ for non-commercial clinical trials and the duplicative application process that often involves research governance, ethics, the research sponsor and, for trials involving medicinal products, the MHRA. This can indeed be a time-consuming and often frustrating process. I would, however, like to respond to a num...
Dear Editor
The paper by J Harris is well thought out and certainly discusses one of the most difficult issues a doctor may face; this includes not only breaking bad news but also helping his/her patients with any ensuing decisions regarding 'end of life decisions'. As a paediatrician, one faces the additional difficulty that one's patient is often unable to voice his/her wishes or feelings. When faced with hav...
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