Legal Justice in Organ Allocation. A Legal Perspective on the Failure of the German Organ Allocation System
The German organ allocation system is out of joint. In July 2012, the medical community as well as the broader public got alarmed by several high-profile transplantation scandals, which meanwhile have resulted in a significant decrease in the number of organ donations. Several physicians at different university hospitals have been accused of altering data related to their patients to make them appear sicker than they actually were in order to place them in front of other patients that were on the waiting list for liver donations. The scandal sheds light on the essential normative nature of prioritization decisions and raises the question of ethical and legal justice in public health. The article argues that the regulatory framework of organ allocation in Germany is not in accordance with the constitutional requirements for a state organized allocation order, which directly affects the most fundamental rights of patients. The lack of legitimacy of the current allocation system, which is essentially determined by guidelines of the German Medical Association, makes it impossible to find a satisfactory legal answer to the problem of individual manipulations of the prioritization process by doctors, who arbitrarily try to advantage their own patients.
German transplant group fights to regain public trust
The German Organ Transplantation Foundation has announced that it will reorganise itself in an effort to win back the trust of potential organ donors.1 The announcement comes in the wake of several high profile transplantation scandals that have resulted in a plunge in the number of organ donations.

The number of deceased organ donors was 13% lower in 2012 than in 2011, falling from 1200 to 1046—the lowest number since 2002, the foundation said. At a press conference on 24 April announcing the reorganisation, …
Sources of Information on Lymphoma Associated with Anti-Tumour Necrosis Factor Agents
AbstractBackground: Anti-tumour necrosis factor (TNF) agents, through their intense immunoregulatory effect, have been suspected to increase the risk of malignant lymphoma. However, the classical epidemiological approaches conducted over about the last 10 years have not totally succeeded in addressing the question of a causal or artifactual association. Therefore, the analysis of a substantial set of case reports, although usually considered as poorly generalizable to the general population, could be particularly informative. Two main sources of case reports in postmarketing settings are available; publications in medical journals and reports to pharmacovigilance systems.
 Objective: The aim of the study was to compare the characteristics of case reports from both these sources in order to understand whether they provided the same information for the investigation of the causal link between lymphoma and anti-TNF agents.
 Methods: All case reports of malignant lymphoma in patients treated with an anti-TNF agent published in MEDLINE and all reports to the French pharmacovigilance system up to 1 February 2010 were identified. Cases of malignant lymphoma identified in postmarketing surveillance from both sources were compared regarding the following variables: age, sex, anti-TNF agent involved, indication for use, type of lymphoma, prior or concomitant immunosuppressive drugs and time to onset of lymphoma.
 Results: A total of 81 published case reports and 61 cases reported to the French pharmacovigilance system were compared. In published reports, patients were younger (p = 0.03) and more frequently receiving a first anti-TNF treatment (p = 0.03), particularly infliximab (p = 0.03). Conversely, in the pharmacovigilance system reports, a succession of different anti-TNFs (p = 0.03) and adalimumab (p< 0.0001) were more frequently reported. Lymphomas in patients treated with anti-TNF agents for Crohn’s disease were more prevalent in published cases than in pharmacovigilance reports (p< 0.0001), and in particular involved hepatosplenic T-cell lymphoma. Conversely, rheumatoid arthritis was the main indication for anti-TNF agents in pharmacovigilance reports (p = 0.01). Time to onset was markedly shorter in published cases (median 12 months) than in pharmacovigilance reports (median 30 months; p = 0.0001).
 Conclusions: Characteristics of published cases and those reported to the French pharmacovigilance system differed markedly for all characteristics tested, except sex and the use of prior or concomitant immunosuppressive drugs. Published case reports favoured convincing arguments for drug causation whereas cases reported to the pharmacovigilance system were more disparate but could describe more accurately the reality of lymphoma occurrence in this particular population. These results argue for the use of the pharmacovigilance reports when case reports are used to investigate the causal link between lymphoma and anti-TNF agents at the population level. Data from cases notified to the French pharmacovigilance system did not indicate an increased risk of lymphoma during the early phase of anti-TNF treatment. To confirm this hypothesis, a study combining pharmacovigilance reports from several countries, or, if feasible, a cohort study both with a large sample size and a long duration of follow-up would be required.