Assessment of Psychosocial Functioning in a Large Cohort of Patients with Schizophrenia.

Background: This study addresses the question of whether psychosocial functioning measured by the Personal and Social Performance (PSP) Scale is related to various psychopathological measures in a cohort of patients with schizophrenia.

Methods: The 'Neuroleptic Strategy Study' (NeSSy) performed at 14 German hospitals between 2010 and 2013 compared two treatment strategies instead of individual drugs. Secondary end-points were the two PSP scales as well as measures of quality of life (SF-36) and the Positive and Negative Syndrome Scale (PANSS).

Dopamine D2 Receptor Occupancy Estimated From Plasma Concentrations of Four Different Antipsychotics and the Subjective Experience of Physical and Mental Well-Being in Schizophrenia: Results From the Randomized NeSSy Trial.

Background: Impaired subjective well-being in schizophrenia patients treated with antipsychotics has often been linked inter alia to the antidopaminergic effects of medication. Thus, it is important to capture the association between striatal dopamine D2 receptor occupancy (D2-RO) and global subjective well-being. We examined this association using data from our multicenter, randomized, double-blind Neuroleptic Strategy Study (NeSSy).

Disparate effects of first and second generation antipsychotics on cognition in schizophrenia - Findings from the randomized NeSSy trial.

Cognitive impairment represents a core feature of schizophrenia. Uncertainty about demonstrable benefits of available antipsychotics on cognition remains an important clinical question relevant to patients' quality of life. The aim of our multi-center, randomized, double-blind "Neuroleptic Strategy Study" (NeSSy) was to compare the effectiveness of selected antipsychotics, conventionally classified as second- (SGAs) (haloperidol, flupentixol) and first generation antipsychotics (FGAs) (aripiprazole, olanzapine, quetiapine), on quality of life in schizophrenia.

Anatomical characterization of PDF-tri neurons and peptidergic neurons associated with eclosion behavior in Drosophila.

The peptidergic Pigment-dispersing factor (PDF)-Tri neurons are a group of non-clock neurons that appear transiently around the time of adult ecdysis (=eclosion) in the fruit fly Drosophila melanogaster. This specific developmental pattern points to a function of these neurons in eclosion or other processes that are active around pupal-adult transition. As a first step to understand the role of these neurons, we here characterize the anatomy of the PDF-Tri neurons.

[Adaptive licensing - a threat to patient safety?].

In 2014, a pilot project of the European licensing authority EMA was launched to explore new ways to license medicinal products. The intention of this project is to open up gradual ("adaptive") licensing pathways, with pharmaceutical developing preparations gaining market authorization on the basis of clearly lower-level evidence of effectiveness and risk of damage than before. Their market authorization shall, initially, be restricted, for example, to subpopulations of patients or to selected indications.

Effects of first-generation antipsychotics versus second-generation antipsychotics on quality of life in schizophrenia: a double-blind, randomised study.

Background: Whether or not second-generation antipsychotics (SGAs) represent an advantage over first-generation antipsychotics (FGAs) in the treatment of schizophrenia is not certain. Effectiveness studies published in the past 10 years have not unequivocally confirmed the superiority of SGAs over FGAs. We aimed to compare quality of life in patients with schizophrenia on an FGA strategy with those on an SGA strategy.

Patient-oriented randomisation: A new trial design applied in the Neuroleptic Strategy Study.

Background: The 'gold standard' for clinical studies is a randomised controlled trial usually comparing specific treatments. If the scientific study expands to strategy comparison with each strategy including various treatments, the research problems are increasingly complicated. The strategy debate in the psychiatric community is the starting point for the development of our new design.

Declaration and Handling of Conflicts of Interest in Guidelines: A Study of S1 Guidelines From German Specialist Societies From 2010-2013.

Background: Authors' conflicts of interest may affect the content of medical guidelines. In April 2010, the Association of Scientific Medical Societies in Germany (AWMF) issued recommendations on how such conflicts of interest should be dealt with. Most AWMF guidelines are so-called S1 guidelines developed by informal consensus in a group of experts.

Metamizole (dipyrone)-associated agranulocytosis. An analysis of German spontaneous reports 1990-2012.

Purpose: In 1986, the risk of agranulocytosis prompted German authorities to restrict the indications for metamizole use. After an initial decline, prescriptions increased from <20 million defined daily doses in 1990 to >140 million in 2012. Concurrently, spontaneous reports of agranulocytosis increased from about 10 in 1990 to >50 in 2012.

Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration.

Background: Neovascular age-related macular degeneration (AMD) is the leading cause of legal blindness in elderly populations of industrialised countries. Bevacizumab (Avastin®) and ranibizumab (Lucentis®) are targeted biological drugs (a monoclonal antibody) that inhibit vascular endothelial growth factor, an angiogenic cytokine that promotes vascular leakage and growth, thereby preventing its pathological angiogenesis. Ranibizumab is approved for intravitreal use to treat neovascular AMD, while bevacizumab is approved for intravenous use as a cancer therapy.

Does the pharmaceutical industry influence guidelines?: two examples from Germany.

Background: The recommendations in clinical guidelines are based on clinical trial findings and expert opinion. The influence of drug companies on these two factors is illustrated with two examples.

Methods: A judicially ordered expert review revealed that the market authorization holder (MAH) of gabapentin manipulated study data.

Identification and structural characterization of interneurons of the Drosophila brain by monoclonal antibodies of the würzburg hybridoma library.

Several novel synaptic proteins have been identified by monoclonal antibodies (mAbs) of the Würzburg hybridoma library generated against homogenized Drosophila brains, e.g. cysteine string protein, synapse-associated protein of 47 kDa, and Bruchpilot.

Pathway-controlled fast-track rehabilitation after total knee arthroplasty: a randomized prospective clinical study evaluating the recovery pattern, drug consumption, and length of stay.

Purpose: To investigate fast-track rehabilitation concept in terms of a measurable effect on the early recovery after total knee arthroplasty (TKA).

Methods: This was an open, randomized, prospective clinical study, comparing the fast-track rehabilitation--a pathway-controlled early recovery program (Joint Care(®))--with standard postoperative rehabilitation care, after TKA. Overall, 147 patients had TKA (N = 74 fast-track rehabilitation, N = 73 standard rehabilitation).

EVITA: a tool for the early evaluation of pharmaceutical innovations with regard to therapeutic advantage.

Background: New drugs are generally claimed to represent a therapeutic innovation. However, scientific evidence of a substantial clinical advantage is often lacking. This may be the result of using inadequate control groups or surrogate outcomes only in the clinical trials.

Off-label use of prescription drugs in childhood and adolescence: an analysis of prescription patterns in Germany.

Background: Not all drugs prescribed for children and adolescents are certified for use in these age groups. The present study describes the extent of off-label prescriptions in the outpatient sector and identifies deficits in the quality of product information.

Methods: This analysis is based on patient-specific but pseudonymized drug prescription data for approximately 289,000 0- to 16-year-old members of the Gmünder Ersatzkasse, a German statutory health insurance provider, in the year 2002.

[Off-label use of drugs in paediatrics causes uncertainty].

The off-label use of drugs in paediatrics is a common practice casting doubts on the adequate safety of drug therapy. Regulatory initiatives of European and national legislators aim to address this paucity of clinical drug trials in paediatrics through clarifying regulations and incentives in pharmaceutical law, thereby promoting an increase in the approval of paediatric drugs, the improvement of drug and thus treatment safety. This paper describes the present situation in paediatrics and the legal status of off-label use in pharmaceutical law, medical malpractice law and statutory health insurance law.

An illicit love affair during the Third Reich: who is my grandfather?

More than 60 years after an illicit love affair had occurred between Erika H, wife of a Wehrmacht soldier, and a Polish slave worker during World War II, we could clarify the blood relationships of her daughter Uta. When Erika H had become pregnant both of the men could have fathered the child. Erika H was found guilty of fraternization and imprisoned at Ravensbrück concentration camp.

Hospitalization rates of generic metoprolol compared with the original beta-blocker in an epidemiological database study.

Purpose: A less favourable galenic profile of generic formulations of the beta-blocker metoprolol raised the concern of a higher risk for serious cardiovascular (CV) events. We assessed hospital admission rates for CV diseases and prescription prevalences of various drugs using claims data of statutory health insurances (SHIs) to compare the incidence of serious CV events among users of original and generic metoprolol. Index events included hospitalization due to myocardial infarction, hypertensive crisis and stroke.