FROM OTHER JOURNALS
We scan the Annals of Internal Medicine (www.annals.org), New England Journal of Medicine (www.nejm.org), The Lancet (www.thelancet.com), British Medical Journal (www.bmj.com), Journal of Medical Ethics (http://jme.bmjjournals.com), Canadian Medical Association Journal (www.cma.ca/cmaj.com), and Eubios Journal of Asian and International Bioethics (www.unescobkk.org/index.php?id=2434)for articles of interest to the medical ethics community. For this issue of the IJME we reviewed the August 2006 – October 2006 issues of these journals. Articles of interest from the National Medical Journal of India, Monash Bioethics Review, Developing World Bioethics and some other journals are abstracted as and when they become available.
Tampering with sacrosanct principles
Emergencies and war-like situations have often called on physicians to participate in the interrogation of suspects. It is often impossible for them to oppose such requirements without inviting personal danger. Physicians’ participation in torture has been unequivocally condemned until now. Recently however, these acts are being justified with excuses that they are participating in a “just war” or working for the “generic common good” where shared public interest takes precedence over personal standards of ethics. If ethical principles are compromised to justify the unethical behaviour of health professional, the principles may never again become sacrosanct.
Kottow MH. Should medical ethics justify violence? J Med Ethics 2006; 32: 464-7
Analysing altruism
Altruism literally means unselfishness, an act of benevolence or welfare to others. Sociobiology has studied it extensively to understand its origin and persistence in humans. The author analyses altruism in relation to the non-living components of nature such as rivers, forests, mountains, etc. He examines the ways in which nature-based religions influence altruism, and how this has impacted eco-centric philosophies.
Gupta A. Altruism beyond con-specifics: the role of nature religions. Eubios J Asian Int Bioeth 2006; 16:134-40.
The benefits of “designer babies”
The author, in response to an article in the July issue of EJAIB, says the term “designer babies”, coined by the popular press, has negative connotations and trivialises the benefit to individuals and society of genetic testing and gene manipulation. Preventing the birth of children with severe genetically determined diseases as well as “saviour siblings” is beneficial to individuals and society.
Minnie Sarah, EJAIB. Are the present day ‘designer babies’ a threat to humankind?: Response to ‘A Christian response to the issue of “designer babies” ‘ (Basu M, July 2006). Eubios J Asian Int Bioeth 2006; 16: 151-152.
Belief versus equipoise
The paper argues that it is okay to recruit subjects in a study provided there is equipoise. Equipoise means that the current available knowledge does not clearly show one treatment as superior to another. Patients sometimes feel that they must have a particular treatment which they believe is better. They become desperate to enter a trial to get the treatment. Such patients are in fact coerced by their belief and are not giving truly informed consent. It would therefore be unethical to include them in a trial. The authors explain that personal belief does not supersede expert collective equipoise. Therefore it is not unethical to include such patients in randomised controlled trials.
Allmark P et al. Should desperate volunteers be included in randomised controlled trials? J Med Ethics 2006; 32: 548-553.
Bridging the organs gap
There is a large gap between the number of organs donated and the number of patients on the waiting lists for transplants. The media tend to focus on the most controversial proposals to bridge the gap, such as buying and selling organs, rather than the less dramatic but potentially effective proposals, such as donation after circulatory determination of death. This editorial and three articles in this issue discuss various related problems.
Childress JF Ann. How can we ethically increase the supply of transplantable organs? Int Med 2006; 145; 224-225.
Is off-label off limits?
The author, whose career includes academic research, work as a regulator in government bodies, and board membership in pharmaceutical companies, discusses the use of drugs for off-label purposes. Off-label use is the common practice of prescribing a drug for an indication other than those approved by the FDA. Physicians’ rationale for prescribing off-label is often based on the lack of FDA-approved effective treatments, reports of clinical effectiveness for the off-label use, or both. Industry, motivated by greed, uses legal but questionable tactics to entice physicians to increase prescribing for such off-label use. The author emphasises that physicians must use transparency to minimise the conflicts of interest that result from such tactics. Failure to do so would jeopardise not only their personal integrity but also that of the profession.
Henney JE Ann. Safeguarding patient welfare: who’s in charge? Int Med 2006; 145: 305-307.
Trial of the trials
Patients and their relatives have recently demanded access, in cases of life threatening illnesses, to treatments that are still in the clinical trial stage. Scientists feel that such access will reduce the incentives to conduct clinical trials and would create “massive opportunity for fraud, involving people who are very sick and very desperate.” Spurred by recent court rulings in favour of patients, the FDA has created a task force to find ways to satisfy patient demand while at the same time pursue rigorous data collection and analysis.
Okie SN. Access before approval — a right to take experimental drugs? N Engl J Med 2006; 355: 437-440.
New norms for HIV testing
The Centers for Disease Control (CDC) will shortly issue new guidelines that include HIV testing as part of routine care, with the option to decline testing available to all. Specific written consent and counselling before such tests will no longer be required. This will make AIDS testing similar to testing for all other communicable diseases. The authors discuss the rationale behind this move.
Bayer R et al. Changing the paradigm for HIV testing — the end of exceptionalism. N Engl J Med 2006; 355: 647- 649.
Human bodies are a public resource
Patients have questioned the use of their voluntarily donated tissues for purposes other than those stated in the consent. The author, a professor of law and bioethics, discusses the legal and ethical questions that arise from designating our bodies/tissues as personal property. She warns that doing so would deprive society of beneficial research. Instead, she recommends that we consider “our bodies as a public resource (which would) also suggest an ethical duty to work toward a just distribution of the benefits of such research, both financial and therapeutic.”
Charo RA. Body of research — ownership and use of human tissue. N Engl J Med 2006; 355:1517-1519.
Looking for answers, not money
Patients dissatisfied with their care are not always seeking monetary compensation. The authors found that only those patients who suffered a major economic loss or those who were in their prime working years asked for monetary compensation. The others asked for a change in the system that would prevent similar injury occurring to others and an explanation or apology from the concerned health care workers.
Bismark M et al. Accountability sought by patients following adverse events from medical care: the New Zealand experience. CMAJ 2006; 175: 889-894.
Who needs an ethics consultation?
The authors surveyed physicians at a community hospital in the US to determine what factors influence a doctor’s decision to ask for an ethics consultation. They found that doctors who believed they were already proficient in ethics and doubted the ability of outsiders to grasp the complexity of a case, rarely called a consult. Doctors who appreciated alternative points of view were more likely to call a consult.
Orlowski JP et al. Why doctors use or do not use ethics consultation. J Med Ethics 2006; 32:499-503
Cut out the terminology
Through detailed interviews with 30 elderly outpatients, the authors found that patients cannot fully comprehend the medical terminology of utility versus futility of treatment when making end of life decisions. Instead doctors should discuss treatments in terms of likelihood of success, the financial as well as emotional cost to the patient and family, the possible prolonging of life and the quality of that life.
Rodriguez KL et al. Perceptions of patients on the utility or futility of end-of-life treatment. J Med Ethics 2006; 32: 444-449
Legalise organ donation
The author, a surgeon in a transplant programme, argues for legalisation of organ donation to prevent exploitation of donors. Donation benefits not only the recipient but also the family of the recipient, the transplant centre and society at large. In contrast, the only benefit accruing to the donor under the current legal climate is being ahead in the queue to receive an organ donation should she/he ever need one. She points out the contradiction in allowing sale of body tissues, such as sperm, ovum, hair, and blood, and even sale or lease of an intact body, through prostitution or surrogate motherhood, but banning the sale of a kidney or liver. She argues that if people can be offered payment for participating in research trials, then organ donors should get adequate compensation. She suggests an autonomous body to regulate the donation process with the exclusion of non-residents to prevent exploitation of people from developing countries.
Freedman A. Payment for living organ donation should be legalized. BMJ 2006; 333:746-748.
Unprecedented business concept
This issue of Lancet is devoted entirely to HIV and all articles are available online for free. Lancet has broken precedent by advertising products like cell phones, credit cards and clothing in this issue to participate in ‘Product Red’. This business concept was introduced by Bono, a celebrity rock singer, to raise money for The Global Fund to fight AIDS. A company creates and sells a Red Product with a percentage of profits going to the fund. The various articles pertaining to HIV in this issue address concerns like social stigma, the relative merits of prevention strategies, building infrastructure to deliver treatment, etc.
Lancet 2006; 368(9534)
Private profit, public loss
A pharmaceutical company produces a drug through the steps of research, development, manufacturing and promotion and then guarantees itself mega profits through intellectual property rights and patent law. The author discusses each step to show how the company short changes public good for personal benefit and offers solutions that would reverse this outcome.
Mintzberg H. Patent nonsense: evidence tells of an industry out of social control. CMAJ 2006; 175: 374.
Suitcase surgeries
Middle-income patients from America are increasingly looking to get their elective but necessary surgeries at foreign hospitals that are certified for quality by US regulatory agencies. The lower and therefore affordable cost of health care is the result of lower wages paid to health care workers in other countries as well as lower costs of medical technology in those countries. As insurance coverage is becoming unaffordable to middle income workers in the US, many more are likely to opt for this route for their care. Concerned health industry leaders in USA could try to restrict this phenomenon but a better option would be to review and reduce the cost of health care in USA.
Milstein A et al. America’s new refugees — seeking affordable surgery offshore. N Engl J Med 2006; 355:1637-1640.
Ground realities of research
The authors discuss the difficulties they faced when conducting a study on diabetes in a rural community. The researchers report making special efforts to follow the Indian Council of Medical Research’s guidelines for biomedical research, taking informed consent from participants after explaining to them what the research involved. But they found that they had to work with local community heads and translators, and face the local political tensions. These tensions, and the overall poverty in which the community lived, render the guidelines meaningless, the authors write. “Thus any activity that requires the use of free will by and willing consent of, the volunteers is vetted by their leaders.” Further, the researchers felt demands were made to extract financial compensation in exchange for participation and giving informed consent, even when there was no risk to the research. This article is worth reading for it may represent the perspective of many researchers.
Mitra A, Bhattacharya D. Ethical problems faced in villages of rural bengal while conducting researches on chronic diseases like diabetes. Indian J Med Sci2006;60:475-484.
Criteria for intradermal rabies vaccine
This editorial discusses the government’s response to the demand by health activists for availability of a safe rabies vaccine. It is a matter of shame that public hospitals in India continued to use the Semple vaccine though it is known to have serious side effects. They did so on the excuse that the safer cell culture vaccines were too expensive. Eventually in 2006 the government was forced to approve the intradermal use of the cell culture vaccine, which requires one-tenth of the intramuscular dose. By doing so, they were only approving what the WHO had endorsed in 1992. But hurdles remain. The vaccine vial size is appropriate for intramuscular injection, which means wasting the excess vaccine or getting the patient to bear this extra cost. Instead of forcing drug companies to manufacture smaller vials, the government has issued an order that intradermal use is approved only for those health facilities receiving a minimum of 50 patients a day for the anti-rabies shot… People unlucky enough to go to a health centre receiving less than 50 patients a day for the shot must pay the full cost of the safer vaccine. Presumably their other choice is to take the unsafe vaccine or go without vaccination altogether,
Count heads to decide the route of injection. Editorial. BODHI 2006 Sep-Oct; 13 (4): 73-4.
A voluntary price cut?
This editorial comments on the government’s much-publicised announcement that it had managed to persuade 11 drug companies to voluntarily “reduce 886 formulations by anywhere from 0.26 to 74.53 per cent.” The writer notes that 886 formulations are just 1.5 per cent of the over 60,000 manufactured all over India. Second, even this number is misleading because it counts different strengths of the same brand separately; most of the brands are obscure and not sold by retail chemists; some price reductions are as small as one or two paise, for which no one returns change any more; some brands contain medicines already under government price control, and a reduction indicates that even here there is sufficient margin to reduce by20 per cent; others have such high profit margins that a 20 per cent reduction will still permit 970 per cent profit. Such “voluntary reductions are meaningless. “The whole exercise is meant to divert attention from the real issue: exorbitant profiteering in the business of making and selling of life-saving essential medicines.
