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Jan-Mar2003-11(1)
FROM OTHER JOURNALS
The following journals are scanned routinely
for articles of interest to the medical ethics community: Annals of Internal
Medicine (www.annals.org), New England
Journal of Medicine (www.nejm.org),
Journal of the American Medical Association (www.jama.ama-assn.org),
Lancet (www.thelancet.com), BMJ
(www.bmj.com), Canadian
Medical Association Journal (www.cma.ca/cmaj), and The
Eubios Journal of Asian and International Bioethics (www.biol/tsukuba.ac).
For this issue of IME, we reviewed the Aug-Oct 2002 issues of these journals.
Articles of interest from hard copies of other publications including the
National Medical Journal of India, Monash Bioethics Review, and Developing World
Bioethics are abstracted as and when they become available.
If you come across an article you feel should be
included, please forward it tommamdani@attbi.com
Science, belief, and ethical practice
Medical practice based on evidence is said to be
the most ethical. But doctors may have to deal with the opposing demands of
conviction in unproven but widely used techniques. The pulmonary artery catheter
is "the mainstay of haemodynamic monitoring and management of critically ill
patients", but there is evidence suggesting it is of questionable benefit, even
harmful. Now, a trial of this catheter on 6,000 patients will involve the
intensive care community as a whole, with ICUs all over the UK. In such a
situation, there will be doctors whose patients are randomised not to receive a
pulmonary artery catheter, but who believe that the catheter would be a better
option. They must continually remind themselves that their beliefs are not
supported by strong scientific evidence. The writer describes this as "the
perfect example of commitment to greater scrutiny and optimisation of practice
that we must all engage in, across all fields of medicine".
Angus Derek, Black Nick. Editorials Wider
lessons of the pulmonary artery catheter trial: Intensivists are rising to the
challenge of evaluating established practices. BMJ 2001; 322:
446.
The larger picture
"Every element of a research ethics review-the
balance of risks and benefits, the assurance of rights for individual
participants, and the fair selection of research populations-can be affected by
the political and human rights background in which a study is done." However,
this context is not routinely considered in the ethics review process. The
authors provide suggestions on how such a perspective will help review boards in
the decision-making process.
Kass Nancy E, Beyrer Chris. Human rights,
politics, and reviews of research ethics. Lancet 2002; 360:
246-51.
New research guidelines
The American Institute of Medicine has issued new
guidelines for protecting human research subjects. It calls for improving
informed consent practices. The IOM report is available athttp://www.iom.edu.
Vastag, B. New Focus on Research Participant
Protection. JAMA 2002;288 (16):1973.
Support the freedom to publish
The authors describe a dispute between a researcher
and the manufacturer of a drug. When the researcher insisted on publishing her
data considered adverse by the manufacturer, she had to face legal harassment
from the company and got no assistance from her hospital or the university. The
authors are firm in siding with the researcher and suggest ways that such
conflicts could be handled in the future.
Nathan, DG and Weatherall, DJ. Academic Freedom
in Clinical Research. N Engl J Med 2002; 347(17):1368-1371.
The industry's influence
The relationships between academic institutions and
private companies are increasing with faculty members and universities having
increasingly strong financial and non-financial incentives to participate
directly in the development of drugs, devices, and diagnostic tests. Many
negative implications of this trend have been recognised. The authors outline
seven areas in which critical choices are to be made and discuss how to face
them.
Moses, H et al. Collaborating with industry -
choices for the academic medical center. N Engl J Med
2002;347(17):1371-1375.
Working with the private sector
Cooperation between academic institutions and the
private sector does not always run smoothly. The authors point to the need for
guidance on entering into partnership with a commercial partner and describe
their institution's experience in formulating guidelines for its staff.
Walt, G et al. Working with the private sector:
the need for institutional guidelines. BMJ 2002; 325(7361):
432-435.
Researchers must document ethical issues
Clinical investigators rarely describe the
rationale for ethically controversial features of study design, or procedures
instituted to enhance the protection of the subjects, or how they ensured
informed consent. To promote public accountability, the article recommends a
policy of extensive reporting of pertinent ethical issues.
Miller FJ, Rosenstein DL. Reporting of ethical
issues in publications of medical research. Lancet 2002; 360:
1326-28.
Strengthen ethics committees
Research involving humans is subject to codes of
ethical conduct that mandate review, approval, and monitoring of clinical trials
by research ethics committees (RECs). The article recommends that RECs have a
prominent role in ensuring that trial results are publicly disseminated and
proposes specific responsibilities for the funders, host institutions, and
consumers.
Mann H. Research ethics committees and public
dissemination of clinical trial results. Lancet 2002; 360:
406-08.
The scientific-clinical interface
While ethics is discussed as it pertains to
clinical research, there is a need for such discussion in basic science
research, because both are increasingly intertwined as in stem cell research. As
potential financial rewards or fame beckon, it is difficult to instil sound
moral thinking in researchers.
Mitka M. Emphasis on ethics increases at basic
and clinical research interface. JAMA 2002; 288 (13): 1577.
Non-financial conflicts
Increasing attention has been paid to financial
conflicts of interest in research. Non-financial conflicts of interest on the
part of investigators and institutions are just as important. Investigators are
motivated by the desire to advance knowledge, prestige, and career advancement.
Institutions wish to enhance their reputation as research centres. These
interests cannot be eliminated but need to be managed appropriately.
Levinsky N G. Nonfinancial conflicts of
interest. N Engl J Med 2002; 347(10): 759-761.
Tired doctors are dangerous
Sleep deprivation due to extended work hours leads
to fatigue which impairs human performance. In this article, the authors discuss
current and proposed policies concerning clinicians' work hours and fatigue. A
comprehensive strategy to reduce fatigue is recommended.
Gaba DM and Howard SK. Fatigue among clinicians
and the safety of patients. N Engl J Med 2002; 347(16): 1249-1255.
Ethics in health policy
To address the problem of inequality in health
care, the authors recommend that policy makers must determine which inequalities
lead to inequitable outcomes and assess cost-effectiveness of interventions.
Ethics and social science, rather than agenda setting and lobbying, should take
centre stage in this international policy debate.
Oliver A, Healey A, Le Grand J. Addressing
health inequalities. Lancet 2002; 360: 565-67.
Dangerous NGOs
The author describes working in a remote rural
clinic in Nepal and struggling with outdated or very high cost medicines donated
by NGOs. As there was an established culture of belief that Western is best, he
had to be extra careful to teach good medical practice which was sympathetic to
the local customs. He says that though NGOs fulfil a valuable role, their
charitable status should be removed if they persist in dangerous practices.
Woolrich-Burt L. First do no harm: does the
Hippocratic Oath extend to developing countries? BMJ 2002; 325(7367):783.
More than just skill
When it comes to doctoring, the term 'good'
increasingly functions as a descriptive label that denotes having met certain
tests of competency. A poor doctor is generally credited with good intentions
but inadequate knowledge or skills required for the job. A bad doctor, however
skilled, is one with bad intentions, undesirable values, suspect, occasionally
evil, motives. Judging someone a bad doctor implies serious defects of moral
agency, even though these may coexist with commendable aspects of medical
practice. To become good doctors, medical education should teach reflection and
sensitivity along with skills.
Hurwitz B and Vass A. What's a good
doctor, and how can you make one? BMJ 2002; 325: 667-668.
Why patients trust doctors
Despite the media's
fixation with medical errors and damaged patients, most doctors are good doctors
in the eyes of most patients. Patients' ratings of doctors' interpersonal skills
are strongly related to trust. To patients, trust means honesty, openness,
responsiveness, having one's best interests at heart, and willingness to be
vulnerable without fear of being harmed.
Coulter A. Patients' views of the good doctor:
Doctors have to earn patients' trust. BMJ 2002; 325: 668-669.
Doctors and alternative medicines
This is an extremely important article for Indian
physicians. The authors have defined a risk-benefit framework that can be
applied to individual cases to determine appropriateness of using these
therapies. The physician can formulate a clinically sound and ethically
appropriate plan even in the absence of scientific evidence for these therapies
by keeping certain well defined issues in mind.
Adams KE et al. Ethical considerations of
complementary and alternative medical therapies in conventional medical
settings. Ann Int Med 2002; 137: 660-664.
Why some people want to die
Oregon's 1997 Death with Dignity Act legalises
physician-assisted suicide. Since then many hospice nurses and social workers
have provided care for a patient who requested assistance with suicide. The
majority of these requests had been discussed at a hospice interdisciplinary
conference on patient care. Desire for control was a very important reason
for these requests. Less important were depression, lack of social support and
fear of being a financial drain on family members.
Ganzini L et al. Experiences of Oregon nurses
and social workers with hospice patients who requested assistance with suicide.
N Engl J Med 2002; 347 (8): 582-588.
Is all technology good?
The author feels that as a society we are more
fascinated by technology and losing touch with human issues. He illustrates his
point of view by giving examples in his field where the latest technological
advance is pushed indiscriminately.
Sarmiento A. Are we losing objectivity? Journal
of Bone and Joint Surgery 2002; 84: 1254-1258.
Food or medicines?
This editorial comments on the promotion of dietary
supplements of unproven value, as medication. Promotional techniques range from
direct-to-consumer advertising, to getting doctors to prescribe them, and
stocking them in pharmaceutical stores. It is unethical for doctors to prescribe
untested products, particularly as "the poor of this country are made to
continue paying through their nose for 'nutritional/dietary supplements' at the
cost of two square meals a day," notes the writer.
Prescribing dietary/nutritional supplements:
where is the evidence? Editorial. Bulletin on Drug and Health Information 2002;
9 (3): 65-67.
Social responsibilities in genetic research
The Australian National Health and Medical Research
Council's guidelines on gene therapy have approved somatic gene therapy but
recommended a temporary ban on germ cell gene therapy which makes inheritable
changes with unknown long-term consequences. The writers examine the question:
does our duty not to create new risks for future generations over-ride our duty
to provide treatment to the present generation? They conclude that "the
community should take account of the interests of its successors but this should
not immobilise us in the decisions we make for the present."
Loane S and Coady CAJ. Genetic manipulation and
our duty to posterity. Monash Bioethics Review 2002; 21 (2): 12-22.
Can the poor give informed consent?
The writer describes her experiences as a member of
an ethics review board and a professor at a public teaching hospital in Manila.
Poverty and the marginalisation of the poor, a highly commercial medical system,
the authority given to physicians, and impersonal, alienating hospital settings
all combine to create an environment undermining people's ability to exercise
free and informed consent. "In the Philippine research context, if a doctor
requests a hospitalized patient to participate in a research project, then the
patient is unlikely to refuse."
Alvarez-Castillo F. Limiting factors impacting
on voluntary first person informed consent in the Philippines. Developing World
Bioethics 2002; 2 (1): 21-27.
More on informed consent
Few practical guidelines exist on how to ensure
that research participants in less-developed countries understand the consent
form before enrolment. In a study of HIV-1 transmission in Haiti, participants
were required to pass an oral examination on the contents of the consent form
with a passing score of 12/15 (80%) before enrolment. Counsellors (80%) rather
than physicians (20%) achieved better outcomes.
Fitzgerald DW et al. Comprehension during
informed consent in a less-developed country. Lancet 2002; 360: 1301-02.
Making compassionate residents
House staff speak of residency training as a 'test
of survival' after which their 'real' careers begin. However, these years will
profoundly influence them as future physicians. Narratives are used in this
academic programme to encourage self-reflection in order to make them better
physicians, more compassionate caregivers and more fully developed human beings.
Brady D W et al. "What's important to you?":
The use of narratives to promote self-reflection and to understand the
experiences of medical residents. Ann Int Med 2002; 137(3):
220-223.
Do kidney sales benefit vendors?
The authors describe the economic and health
effects of selling a kidney. The survey of 305 individuals who had sold a kidney
in Chennai about six years prior to the survey revealed that the average amount
received was $1070. The main reason for selling was to pay off debts. But 75%
were still in debt at the time of the survey and over 86% reported a
deterioration in their health status, with a 30% decline in family income after
the nephrectomy. 79% said that they would not advise others to sell a
kidney.
A commentary on this article summarises the various
issues involved in the debate on cadaveric and living donor organ donation.
Selling an organ has been advocated by some as a way out of poverty. The study
provides clear proof that this is not true. The organ recipient is the only one
who stands to gain.
Goyal M et al. Economic and health consequences
of selling a kidney in India. JAMA 2002; 288: 1589-1593. Rothman DJ. Ethical and
social consequences of selling a kidney. Commentary. JAMA 2002; 288: 1640-1641.
An ethical market in live organs?
An article suggesting that the selling and buying
of human organs can be made ethical - with the trade channelised through a
single buyer such as the government health service - triggered off a series of
electronic responses. Marino and others point out that this system will appeal
only to a restricted group of people, the cash-strapped. Wight notes that a
market in live kidneys may lead to a collapse in organ donation, thus heart and
liver transplantation could be seriously damaged. Wigmore et al question the
notion that a single buyer would avoid donor exploitation. No guarantee exists
that the NHS would not exploit people. The potential for harm to the donor
remains. Also, fair distribution among recipients needs to be addressed.
Harris J, Erin C. An ethically defensible
market in organs. BMJ 2002; 325: 114-115. Letters in response: Marino, I et al.
Market of organs is unethical under any circumstances. BMJ 2002; 325: 835 Aug
23. Wight, JP. Proposal is problematic. BMJ 2002; Aug 6. Wigmore, SJ et al.
Defending the indefensible? BMJ 2002; July 26.
Informing legal judgements on medicine
Judges are expected to examine the basis of all
expert testimony before it is introduced at trial to ensure that it meets the
same standards of intellectual rigour that professionals use outside the
courtroom. However, courts have been inconsistent in measuring this testimony
against the standards of medical practice. Physicians should respond by
correcting courts' misinterpretations of medical practice and assisting in the
development of legal standards that encourage thoughtful and informed
consideration of medical testimony by judges and juries.
Kassirer JP and Cecil JS. Inconsistency in
evidentiary standards for medical testimony: disorder in the courts. JAMA 2002;
288 (11): 1382-1387.
Internet medicine and the law
The legal community needs to devise ways to address
the expansion of medicine over the Internet. For a country like India,
telemedicine and cybermedicine offer many advantages. However, concerns about
quality remain. The book discusses malpractice, confidentiality, and informed
consent as well as licensure, credentialing and liability; access including
standards for use, confidentiality, privacy; and economic issues, reimbursement
for services, funding and cost effectiveness.
Sivaswamy R and Kumar J. Doctors on the
internet - legal and practical implications. Eubios Journal of Asian and
International Bioethics 2002; 12: 185-8.