Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain.

Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and objective account of these trials is lacking. The aim of this study was to describe and evaluate the clinical trials performed in the German Democratic Republic (GDR) based on archival material from the health system and the secret service. We found documents relating to 220 trials involving more than 14,000 patients and 68 Western companies. However, no record of patient information forms or systematic documentation regarding the provision of patient consent was discovered. There was no evidence to suggest that the trials systematically and intentionally damaged patients. The trials were conducted without the knowledge of the public. GDR legislation stipulated that patients must consent to the trials, but no evidence was found to suggest that patients were systematically informed. Documents suggest that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. The GDR agreed to the trials due to impending bankruptcy and Western pharmaceutical companies capitalised on this situation.

Ageism and equality.

This paper rebuts suggestions made by Littlejohns et al that NICE is not ageist by analysing the concept of ageism. It recognises the constraints that finite resources impose on decision making bodies such as NICE and then makes a number of positive suggestions as to how NICE might more effectively and more justly intervene in the allocation of scarce resources for health.

National Institute for Health and Clinical Excellence appraisal and ageism.

The requirements of the UK Equality Act 2010 and some high profile criticism for using a potentially ageist methodology have prompted the National Institute for Health and Clinical Excellence (NICE) to assess the processes and methodology it uses to make appraisal decisions. This paper argues that NICE has established rigorous systems to protect against ageist decisions, has no track record of ageism and is well placed to meet the requirements of new UK equality legislation.

School-based smoking prevention programmes: ethical aspects.

School-based health education has the potential to inform and educate young people, in order to promote healthy behaviours among them, which will help to prevent diseases and social problems. The present study gives an overview of several ethical issues which must be considered in different phases of school-based smoking prevention programs. This will help health educators, public health professionals and researchers in their activity of health education in schools. The ethical issues must be taken into consideration during all the activities and refer to the involvement of officials, schools, parents, young people who participate into the program, authors and persons/institutions responsible with the implementation, evaluation or funding of the programs. The application into practice of these ethical principles, influence the quality of the health education, its acceptability BY the target group and the correctness of results. Also, it prevents possible problems and misunderstandings between persons and institutions involved in the health education and smoking prevention process, which could seriously affect and even destroy implementation of such health education activities.

Low organisational justice and heavy drinking: a prospective cohort study.

OBJECTIVES: To investigate whether low perceived organisational injustice predicts heavy drinking among employees. METHODS: Data from a prospective occupational cohort study, the 10-Town Study, on 15 290 Finnish public sector local government employees nested in 2432 work units, were used. Non-drinkers were excluded. Procedural, interactional and total organisational justice, heavy drinking (>/=210 g of absolute alcohol per week) and other psychosocial factors were determined by means of questionnaire in 2000-2001 (phase 1) and 2004 (phase 2). Multilevel logistic regression analyses taking into account the hierarchical structure of the data were conducted and adjustments were made for sex, age, socio-economic status, marital status, baseline heavy drinking, psychological distress and other psychosocial risk factors such as job strain and effort/reward imbalance. RESULTS: After adjustments, participants who reported low procedural justice at phase 1 were approximately 1.2 times more likely to be heavy drinkers at phase 2 compared with their counterparts reporting high justice. Low perceived justice in interpersonal treatment and low perceived total organisational justice were associated with increased prevalence of heavy drinking only in the model adjusted for sociodemographics. CONCLUSIONS: This is the first longitudinal study to show that low procedural justice is weakly associated with an increased likelihood of heavy drinking.

Rights, responsibilities and NICE: a rejoinder to Harris.

Harris' reply to our defence of the National Institute for Clinical Excellence's (NICE) current cost-effectiveness procedures contains two further errors. First, he wrongly draws a conclusion from the fact that NICE does not and cannot evaluate all possible uses of healthcare resources at any one time and generally cannot know which National Health Service (NHS) activities would be displaced or which groups of patients would have to forgo health benefits: the inference is that no estimate is or can be made by NICE of the benefits to be forgone. This is a non-sequitur. Second, he asserts that it is a flaw at the heart of the use of quality-adjusted life years (QALYs) as an outcome measure that comparisons between people need to be made. Such comparisons do indeed have to be made, but this is not a consequence of the choice of any particular outcome measure, be it the QALY or anything else.

A NICE fallacy.

A response is given to the claim by Claxton and Culyer, who stated that the policies of the National Institute for Health and Clinical Excellence (NICE) do not evaluate patients rather than treatments. The argument is made that the use of values such as quality of life and life-years is ethically dubious when used to choose which patients ought to receive treatments in the National Health Service (NHS).

Indecent medicine: in defense of the absolute prohibition against physician participation in torture.

In a recent article, Gross (2004) argues that physicians in decent societies have a civic duty to aid in the torturing of suspected terrorists during emergency conditions. The argument presupposes a communitarian society in which considerations of common good override questions of individual rights, but it is also utilitarian. In the event that there is a ticking bomb and no other alternative available for defusing it, torture must be used, and physicians must play their part. In an earlier article, Jones (1980) also argues in favour of physician participation in torture, going so far as to enthusiastically endorse the allocation of research resources as well to ensure that the ability to meet emergency situations is as efficient as scientifically possible. I argue against both these views and defend the absolute prohibition against torture generally, and against any participation by physicians in particular. I show that these arguments are incompatible with liberal or decent societies, and that the institutional requirements for making torture effective would constitute an unacceptable degradation both of medical ethics and practice, as well as of political institutions in general.

Combined effects of uncertainty and organizational justice on employee health: testing the uncertainty management model of fairness judgments among Finnish public sector employees.

We examined whether the combination of uncertainty (lack of work-time control, and negative changes at work) and organizational justice (i.e., justice of decision-making procedures and interpersonal treatment at work) contributes to sickness absence. A total of 7083 male and 24,317 female Finnish public sector employees completed questionnaires designed to assess organizational justice, workload and other factors. Hierarchical regression showed that after adjustment for age, income, and health behaviors low procedural and interactional justice were related to long sickness absence spells. In accordance with the uncertainty management model, these associations were dependent on experienced work-time control and perceived changes at work.

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.

Pharmaceuticals, the state and the global harmonisation process.

This article examines how regulatory agencies' mission to protect and promote public health, enshrined in legislation, has been shaped and limited by commitments to the commercial interests of the pharmaceutical industry. It is argued that the regulatory state has become largely a 'competition state' which considers its primary role to be the maintenance of industry's competitive position in world markets. By examining regulatory developments across the EU, Japan and the US, I shall explain how the competition state became a building block for the global harmonisation process. To legitimise the global harmonisation process in terms of their mission to protect and promote public health, regulators claim that it does not lower safety standards and will accelerate the availability of pharmaceutical innovations to patients who need them. However, evidence is presented to suggest that these legitimising claims are not tenable.