In 2020 The United States Food and Drug Administration?s (FDA) Center for Drug Evaluation and Research (CDER) approved 53 novel drugs, five more than in 2019, but still an aggressive number when compared with 2015 when only 45 new drugs were released to the market. CDER, the largest department within the FDA, has robustly approved a rising number of generic drugs in the last several years, increasing their accessibility and reducing patient and payor costs.

To identify clinical characteristics of residents with a diagnosis of overactive bladder (OAB) and/or urinary incontinence (UI) to determine the prevalence of comorbidities, severe mobility impairment (SMI), moderate-to-severe cognitive impairment (MSCI), and a toileting program and the response to that program. Cross-sectional retrospective analysis. Skilled nursing facilities. Residents with a diagnosis of OAB and/or UI and an age range, and gender frequency-matched 1:1 control cohort without OAB and/or UI. None. De-identified Minimum Data Set data 3.0 records (October 1, 2010, to September 30, 2012). Of the 175,632 residents, 65% had a diagnosis of UI and 1% had a diagnosis of OAB. Those with UI and/or OAB were more likely to have MSCI (mean Brief Inventory of Mental Status score 10.2 ± 4.5 vs. 12.5 ± 3.6; P = 0.001) and SMI (49.4% vs. 26.4%; P < 0.001), multiple comorbid conditions, falls and falls with injury, hip fractures (5.5% vs. 4.9%; P < 0.001), urinary tract infections (21.4% vs. 16.5%; P = 0.001), and moisture-associated skin damage (5.2% vs. 2.6%; P = 0.001) than the control cohort. Toileting programs were attempted more often (17.0% vs. 5.1%; P < 0.001) in those with UI and/or OAB but were only minimally successful, with 4.2% having decreased wetness and 0.9% being completely dry. Residents with UI and/or OAB exhibit a higher burden of MSCI, SMI, and comorbidities than do residents without these diagnoses. Nonpharmacologic therapies such as toileting programs should be a primary focus in the nursing facility.

The use of atypical antipsychotic drugs in long term care facilities continues to be the subject of news and government reports. These reports have generated concern about the utilization of antipsychotic drugs in patients with dementia related disturbances. The FDA Boxed Warning statement in the antipsychotics’ product information identifies a potential increased risk of mortality in elderly individuals taking antipsychotic medications for dementia-related behavior. The 2012 American Geriatric Society Beers Criteria also recommends avoiding antipsychotic medications use for behavior problems in dementia due to an increased risk for stroke and mortality. CommuniCare Family of Companies (CommuniCare) and Omnicare, Inc.’s efforts at the reduction of antipsychotic drug use are consistent with evidence-based clinical practice and CMS nursing facility regulations.

The European Community Regulation governing clinical research in paediatrics, which came into force in January 2007, is aimed at ensuring a better care for children and setting quality and scientific standards for evidence-based use of medicines in Paediatrics. The related obligation system, affecting the medical community and even more the pharmaceutical industry, is expected to increase the number of controlled trials, in order to have more drugs approved in Paediatrics and less off label use. Two surveys in 16 countries on the pre-Regulation period (2005-2007) were conducted to better understand the status of paediatric research at the start of the new era. The experience of paediatrc trials is mostly in Phase III, and the major hardles were found in preparing an appropriate protocol and in practical issues (to be intended as submission document preparation and logistic issues). Thus, it is assumed that many trials before the Regulation are investigator's initiated and that the support by industrial sponsors has been poor when compared to other developmental projects. The ranking by therapeutic area (respiratory>endocrinology>infectious diseases>oncology) does not fit with the needs for controlled trials identified by EMA in a survey on the off label use of non-authorised medicines for children. All together these data on years 2005-2007 support the need expressed by the Regulation for a higher qualitative and quantitative commitment in Clinical Research in Paediatrics. A third questionnaire (results expected October 2011) is aimed at monitoring the first years of the Regulation (2007-2010), in order to understand its initial impact.

To evaluate the impact of the new European paediatric regulatory framework on the activities of Ethics Committees operating in Europe and to assess their involvement and interest in paediatric research. Task-force in Europe for Drug Development for the Young Network of Excellence and Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials project set up an inventory of Ethics Committees existing in Europe and conducted a survey on their approach to paediatric trials. Ethics Committees operating in 22 European Countries participated in this survey. Results showed a high lack of knowledge, understanding and awareness of the current European paediatric regulatory framework and a lack of involvement of Ethics Committees in paediatric research, especially in terms of training and education, demonstrated also by the decreasing number of Ethics Committees answering exhaustively to the whole questionnaire. The majority of participating Ethics Committees expressed interest in future initiatives related to paediatric research. Despite a limited knowledge and understanding of the current paediatric regulatory framework, a significant number of Ethics Committees operating in Europe show interest in initiatives related to paediatric research. Networking may be an essential tool to be used to enhance Ethics Committees role in supporting paediatric research. Any initiative should be undertaken at European level in collaboration with European Union Institutions.

To the Editor: We appreciate the interest of Drs. Wise, Saayman, and Frost in our analysis of patients treated with a recombinant surfactant protein (SP)-C surfactant (Venticute; Nycomed GmbH; Konstanz, Germany).1Taut FJ Rippin G Schenk P et al.A Search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute).Chest. 2008; 134: 724-732Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar They note that the relatively early treatment of ARDS patients with surfactant may be associated with a better outcome and ask whether a lead-time bias might have influenced our observation that the outcome in patients with direct lung injury appeared to be better than that for patients with indirect lung injury. We have compared the time from ARDS diagnosis to randomization (after which treatment was given within 2 h) for patients with direct or indirect lung injury. This mean (± SE) interval was 32.9 ± 1.3 or 26.5 ± 1.1 h (p = 0.0002), respectively. Thus, patients with direct lung injury, who appeared to have a better outcome, actually were randomized and treated 6 to 7 h later than those with indirect injury. Whether this difference is clinically relevant is unknown, but it appears that lead-time bias does not explain our observations. While we would also like to compare the time intervals from intubation to randomization (or treatment), this information is not available. We caution against using published information, including that cited by the correspondents, to compare the time course of surfactant abnormalities in patients with direct lung injury vs those with indirect lung injury. Studies to date have included patients treated with tidal volumes > 12 mL/kg body weight (volumes now known to be inherently injurious2Acute Respiratory Distress Syndrome Network Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome.N Engl J Med. 2000; 342: 1301-1308Crossref PubMed Scopus (10146) Google Scholar) and have not directly compared patients with direct or indirect lung injury. Future comparisons should require that patients be treated with a lung-protective ventilation strategy and that patients with direct or indirect lung injury be prospectively enrolled into a common study. It is very likely that surfactant abnormalities persist for several days after the onset of either direct or indirect lung injury. Although our pooled analysis focused on only the first 24 h of treatment, study of the loss of exogenous surfactant from the lungs of treated patients has previously led us to suggest,3Spragg RG Lewis JF Wurst W et al.Treatment of acute respiratory distress syndrome with recombinant surfactant protein C surfactant.Am J Respir Crit Care Med. 2003; : 167Google Scholar as do the correspondents, that treatment extend beyond that period. Composition of the ideal surfactant for treating patients with lung injury is unknown, and, in addition to either SP-C or SP-B (or relevant analogs), the list of suggested components includes the hydrophilic surfactant proteins SP-A and SP-D, antioxidants, protease inhibitors, phospholipase inhibitors, phospholipase-resistant phosphonolipids, and anticoagulants. Designing the optimal surfactant is clearly a challenging task!

With the dramatic increase in the aging population, the study and care of wounds in the elderly have become priority topics for both researchers and clinicians. The effects of aging on wound healing in humans have remained controversial. The study was a 5-year epidemiological evaluation of standardized data collected regularly during patients' visits at a specialized Wound Care Center with the aim to determine the key factors influencing the healing of chronic lower extremity wounds. In this analysis of 1,158 chronic wounds, the frequency of wound closure was statistically significantly lower in older patients compared with younger patients. The share of closed wounds decreased by nearly 25% in the elderly patients (>or=70 years). The relationship between the patient's age and the proportion of wound closure was nonlinear. The effect of aging on the frequency of wound closure of chronic wounds became clinically apparent after age 60. The chronicity of the wounds was illustrated by their recurrent nature, their long duration, the presence of multiple wounds, and the frequency of concurrent infection. Comorbidity was documented by the coprevalence of up to three underlying diseases related to impaired wound healing. The present study clearly showed that aging affects chronic wound healing negatively.

Studies to date have shown no survival benefit for the use of exogenous surfactant to treat patients with the ARDS. To identify specific patient subgroups for future study, we performed an exploratory post hoc analysis of clinical trials of recombinant surfactant protein-C (rSP-C) surfactant (Venticute; Nycomed GmbH; Konstanz, Germany). We performed a pooled analysis of all five multicenter studies in which patients with ARDS due to various predisposing events were treated with rSP-C surfactant. Patients received either usual care (n = 266) or usual care plus up to four intratracheal doses (50 mg/kg) of rSP-C surfactant (n = 266). Factors influencing the study end points were analyzed using descriptive statistics, analysis of covariance, and logistic regression models. ARDS was most often associated with pneumonia or aspiration, sepsis, and trauma or surgery. For the overall patient population, treatment with rSP-C surfactant significantly improved oxygenation (p = 0.002) but had no effect on mortality (32.6%). Multivariate analysis showed age and acute physiology and chronic health evaluation (APACHE) II score to be the strongest predictors of mortality. In the subgroup of patients with severe ARDS due to pneumonia or aspiration, surfactant treatment was associated with markedly improved oxygenation (p = 0.0008) and improved survival (p = 0.018). rSP-C surfactant improved oxygenation in patients with ARDS irrespective of the predisposition. Post hoc evidence of reduced mortality associated with surfactant treatment was obtained in patients with severe respiratory insufficiency due to pneumonia or aspiration. Those patients are the focus of a current randomized, blinded, clinical trial with rSP-C surfactant.