Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.     

Neonaticides in Hamburg, Germany, from 1998 to 2008

In the analyzed period from 1998 to 2008, the autopsies performed at the Hamburg Institute of Legal Medicine included 13 cases in which an investigation for neonaticide had been initiated by the public prosecutor. The killed neonates showed a nearly equal distribution between both sexes. The most common method of neonaticide was suffocation. Most of the perpetrators were young, unmarried primipara with an average educational background. Almost all of them were suffering under psychological stress and had negated their pregnancy. In most cases, birth and neonaticide happened alone in their flat, and there was no medical attendance in any case. In the cases brought to court the women were charged with manslaughter (Section 212 German Criminal Code) and those found guilty were always granted a mitigated sentence pursuant to Section 213 Criminal Code.     

Bumping into a knife--exculpatory statement or (tragic) accident?

Assessing stab wounds is a common task in forensic medicine. Quite often an accused claims that the victim bumped into the knife. Taking into account all the facts ascertained in the investigations conducted, such a statement can be rapidly disproved in most cases. The present case of a 14-year-old boy fatally wounded by his mother with a kitchen knife examines the aspect of walking into a knife. It is an example that this statement cannot always be regarded as implausible and that every single case has to be reconstructed in detail on the basis of all the investigation results.     

Subject for discussion: is sexual abuse of a sleeping person possible or fantasy or simulated?

There have been reports of sexual acts on sleeping women since ancient times. Whether this is possible at all has been under controversial discussion by lawyers and lay people. The paper presents two cases of non-consenting penetrating intercourse with sleeping women and various legal and expert opinions. The authors discuss the possible influence of drugs and alcohol.     

Predicting discharge in forensic psychiatry: the legal and psychosocial factors associated with long and short stays in forensic psychiatric hospitals

In Germany, both the number of patients treated in forensic psychiatric hospitals and the average inpatient treatment period have been increasing for over thirty years. Biographical and clinical factors, e.g., the number of prior offences, type of offence, and psychiatric diagnosis, count among the factors that influence the treatment duration and the likelihood of discharge. The aims of the current study were threefold: (1) to provide an estimate of the German forensic psychiatric patient population with a low likelihood of discharge, (2) to replicate a set of personal variables that predict a relatively high, as opposed to a low, likelihood of discharge from forensic psychiatric hospitals, and (3) to describe a group of other factors that are likely to add to the existing body of knowledge. Based on a sample of 899 patients, we applied a battery of primarily biographical and other personal variables to two subgroups of patients. The first subgroup of patients had been treated in a forensic psychiatric hospital according to section 63 of the German legal code for at least ten years (long-stay patients, n=137), whereas the second subgroup had been released after a maximum treatment period of four years (short-stay patients, n=67). The resulting logistic regression model had a high goodness of fit, with more than 85% of the patients correctly classified into the groups. In accordance with earlier studies, we found a series of personal variables, including age at first admission and type of offence, to be predictive of a short or long-stay. Other findings, such as the high number of immigrants among the short-stay patients and the significance of a patient's work time before admission to a forensic psychiatric hospital, are more clearly represented than has been observed in previous research.