We scan the Annals of Internal Medicine (www.annals.org), New England Journal of Medicine (www.nejm.org), The Lancet (www.thelancet.com), BMJ (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 Ethics (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 May 2006-July 2006 issues of these journals. Articles of interest from other journals are abstracted as and when they become available.
Doctors under training need adequate supervision to prevent mistakes that may have severe consequences for the patient. A woman lost her life in a New York hospital due to mistakes made by a resident who had been working for a prolonged period without a break. This led to regulation limiting the hours a doctor could work; it also led to better supervision. The article describes a preventable death in the UK in the hope that similar regulation will be enacted in Britain.
Frivolous lawsuits are responsible for rising health costs, according to advocates of tort reform in the US. A group of physicians reviewed a random sample of 1452 closed malpractice suits to assess this view, by determining whether an injury had occurred and if it was due to medical error. Claims that did not involve errors accounted for only 13 to 16 per cent of the malpractice system’s total monetary costs. Of the money spent for compensation, half went towards lawyers’ and litigation costs. The authors conclude that portraits of a system that is stricken with frivolous litigation are overblown and the malpractice system performs reasonably well in weeding out claims without merit. However, the system’s overhead costs are exorbitant and cases take from three to six years to get resolved.
Research sponsors and institutions have an obligation to compensate injured subjects. This is particularly necessary in trials that have commercial sponsors and regardless of who is to blame or whether the participants were paid. According to the contrary view, routine compensation is not necessary because subjects are made aware of the risks through the process of informed consent; they understand the risks and voluntarily agree to participate. While it may be difficult to determine whether a medical problem is related to participation in a clinical trial, especially if it develops months or years later or if a subject has other risk factors, it is ethically imperative that a subject be compensated. European countries provide such compensation but not the US. Legislation to correct this is required.
Many people believe that the threat of liability has hindered development of more effective patient safety programmes in hospitals, but the author says that such a threat is the only force that will bring about change. He says hospitals that do not take appropriate patient safety measures should be held liable under the doctrine of corporate responsibility, which until now was only applied to industries such as automobile manufacture. Hospitals should be held accountable for failing to adopt new technologies that are effective and inexpensive and improve patient safety.
The Canadian health care system will henceforth include private medical care. This may pose ethical dilemmas for the physicians. The three core elements of the medical profession are competence, commitment to the patient’s welfare and medicine as a public trust. However, the introduction of private medicine may divert resources from one area of medicine to another and may have an overall negative impact on patient welfare and certain medical specialties.
Although China’s principal health indices look good, there is a marked disparity between health care in urban areas and rural areas and between regions. Market-oriented health care reforms have left hundreds of millions of rural dwellers unable to afford treatment. Individual spending is compensating for the decrease in government spending on health. This has led to indebtedness and poverty. The public share of health care spending is only 17 per cent as compared to 45 per cent in the US and 70 per cent in Japan. Responding to internal and external criticism, the Chinese government is trying to increase funding to hospitals and clinics and devising an affordable rural medical insurance scheme so that every farmer has access to primary care by 2010.
Clinical research is essential if medical knowledge is to advance and ultimately save lives. The WHO has promoted this goal by initiating a clinical trials registry. This registry has two main principles–all interventional trials, including Phase I trials, and all elements of the 20-item minimum dataset of a trial, must be disclosed at the time of registration. These principles have been arrived at after extensive consultation with all the stakeholders, including the pharmaceutical industry. The details are to be worked out over the next 12 months and the WHO is seeking cooperation from all nations. The WHO initiative will assure transparency and enhance public trust in research. The author requests the mass media to co-operate; the media often portray adverse research events in the most unfavourable light, possibly creating distrust and panic among readers and viewers. He also anticipates that journal editors will have to put aside the Ingelfinger rule in the interests of transparency of registered trial results.
When authors of scientific articles are suspected of commercial bias, editors and owners of journals are rarely accused of the same. It is well known that government organisations and professional societies have influenced journal content. However, commercial influence is less well known and a greater threat. Because editors largely control journal content, their financial and non-financial conflict of interests may lead to publication of articles with a commercial bias. The pharmaceutical industry can exert pressure on editors and owners through large streams of revenue generated by sponsoring journal supplements, reprints of published articles and advertisements in journals. To limit such influence, journals should list all sources of revenue and editors should not only disclose their conflict of interests but also be prohibited from having any commercial ties to the health care industry.
Informed consent is a relatively new concept in clinical research in China. Many still feel it is a mere formality. In a survey done in seven urban hospitals, 225 physicians completed a self-administered questionnaire regarding their attitude towards informed consent and their opinion about alternative models of decision-making. The results show that obtaining the signature was regarded as the most important step but the actual explanation and the patient’s understanding of the treatment were considered as far less important. Most of the physicians were aware that subjects must be told about all aspects of research before they consented, but they did not feel it was necessary to explain the actual procedure of research because, they said, the patients were not sufficiently educated. The physicians felt they could protect the patient’s rights better than the patient herself or himself. Chinese culture emphasises the family and family ties. So obtaining consent from the family or a spouse is common. This was apparent in the results of the survey. The author describes the influence of Confucian philosophy on Chinese society and how this explains the results of the survey.
Funding for research comes from three sources–the government, charities and industry. Research is funded by industry primarily for commercial gain; public benefit is secondary. A number of published articles indicate that industry-funded research is increasing. Such research tends to favour drug treatment over lifestyle modification regimens and promotes expensive drugs over older and cheaper alternatives. Effective mechanisms are needed to protect the interests of people. One way to do this is greater transparency through a declaration of interests, a detailed analysis of treatment guidelines to address industry-driven bias, and greater funding for complex and behavioural interventions that cannot be patented by industry.
Patients groups provide information and support to patients and relatives. However, several such groups would not exist without funding from industry and information about them is not easily accessible. The pharmaceutical industry has asked all manufacturers to declare the groups they fund every year, but such groups also have an obligation to be transparent about their sources of funding.
The European parliament recently announced legislation to facilitate more paediatric research. This is welcome because often the medical profession extrapolates from adult studies when prescribing treatment for children. This may be a harmful approach. Parents may feel reluctant to participate in clinical trials because of recent reports in the media about adverse research events. However, paediatric participation is essential if evidence-based treatments for children are to be determined.