A Decade of Data Protection for Innovative Drugs in Canada: Issues, Limitations, and Time for a Reassessment.

Drug regulators in Canada and in other nations require innovative pharmaceutical companies to submit undisclosed clinical or other data as a condition of approving the marketing of new pharmaceutical products-the origination of which involves considerable effort and investment. Data protection regulations were enacted in Canada in 2006, which-to some extent-closed a loophole in intellectual property law that had previously left innovative companies with no effective data protection for their clinical data. Although the regulations were intended to clarify and effectively implement Canada's international treaty obligations in the spirit of innovation, a review of Canada's first decade of effective data protection shows that Health Canada and Canadian courts have interpreted the scope of data protection for innovative drugs in a narrow manner that undermines and is inconsistent with the intent of the regulations. As the 10-year anniversary of data protection in Canada is this year (2016), this article demonstrates the need to advance Canada's data protection regime into one that consistently contributes to the promotion of investment in pharmaceutical research and development, to the mutual advantage of innovators and patients, in a manner conducive to the social and economic welfare of Canadians.

A novel behavioral health program for family caregivers of children admitted to a transitional chronic ventilator unit.

BACKGROUND: The care of mechanically ventilated pediatric patients is complex and burdensome. It is essential to adequately support the family caregivers of these children to optimize outcomes; however, there is no literature describing interventions for caregivers in this population. RESEARCH QUESTION: This study described a novel behavioral health program and examined its impact on family caregiver engagement and psychological distress on a pediatric inpatient chronic ventilator unit. STUDY DESIGN AND METHODS: Electronic chart review was completed with retrospective and prospective participant enrollment for the purposes of longitudinal evaluation of caregiver engagement. For analytic purposes, participants were grouped into three categories: (1) preprogram, (2) postprogram, and (3) postprogram with completion of psychotherapy. RESULTS: The behavioral health program was associated with increased caregiver participation in rounds, t = 7.76, p = < .001. Parents who completed a course of psychotherapy within the behavioral health program demonstrated reduced time to training completion (F = 5.89; p < .01), higher staff-rated caregiver engagement (F = 3.69; p < .05), and significantly reduced levels of caregiver distress (t = 2.09; p < .05).

Zero effect of multiple dosage of olive leaf supplements on urinary biomarkers of oxidative stress in healthy humans.

OBJECTIVE: We determined the effect of dietary supplementation with an olive leaf capsule or liquid extract on oxidative status of young and healthy male and female subjects. METHODS: This was a single-center, randomized, single-blinded, prospective pilot comparison of the effect of dietary supplementation with olive leaf extracts. Healthy young adult male and female subjects (n = 45) were randomized into three groups and received daily doses of control, capsule, or liquid extract of olive leaf. Urinary F(2 alpha)-isoprostane, 8-hydroxy-2'-deoxyguanosine, and Folin-Ciocalteu total reducing power were measured to assess the impact of supplementation. RESULTS: Baseline values (mean +/- standard deviation) of the biomarkers were 0.24 +/- 0.13 microg, 9.16 +/- 2.94 microg, and 424.9 +/- 121.4 mg of gallic acid equivalents per gram of creatinine, respectively, for the control group. Using these markers, supplementation with liquid or capsule did not alter oxidative status compared with the control group. Possible reasons for the lack of an observed correlation are presented. CONCLUSION: Dietary supplementation with olive leaf extract did not alter the oxidative status of healthy young adults.

Nutritional methodologies and their use in inter-disciplinary antioxidant research.

There has been a significant increase in the volume of research relating to antioxidants and health. The very nature of this research is inter-disciplinary, yet the full potential of such an approach, whereby nutritionists (clinicians), chemists, pharmacists and others all bring their expertise to bear in a concerted way, is rarely achieved. This is perhaps due to a lack of understanding of the methodology and terminology of the various disciplines. In this review, the terminology and features of nutritional studies are examined with particular emphasis on the confounders that may often be ignored by laboratory-based researchers. Attention is drawn to the potential role that ethics approval processes may have in directing outcomes.

Bioactivity of oats as it relates to cardiovascular disease.

The food consumption of oats has increased in recent years due to a perceived association with a range of health benefits. Oats are unusual in that the bran is not as physically distinct as in other cereals. This provides a possible benefit in providing a high beta-glucan content of the grains. However, oats contain many other phytochemicals including a range of antioxidants that may be associated with health benefits, although the evidence for such benefits is largely indirect and often confusing and contradictory. Nevertheless, the consumption of oats as part of a balanced diet does seem a reasonable approach.

Responding to the pandemic of falsified medicines.

Over the past decade, the number of countries reporting falsified (fake, spurious/falsely labeled/counterfeit) medicines and the types and quantities of fraudulent drugs being distributed have increased greatly. The obstacles in combatting falsified pharmaceuticals include 1) lack of consensus on definitions, 2) paucity of reliable and scalable technology to detect fakes before they reach patients, 3) poor global and national leadership and accountability systems for combating this scourge, and 4) deficient manufacturing and regulatory challenges, especially in China and India where fake products often originate. The major needs to improve the quality of the world's medicines fall into three main areas: 1) research to develop and compare accurate and affordable tools to identify high-quality drugs at all levels of distribution; 2) an international convention and national legislation to facilitate production and utilization of high-quality drugs and protect all countries from the criminal and the negligent who make, distribute, and sell life-threatening products; and 3) a highly qualified, well-supported international science and public health organization that will establish standards, drug-quality surveillance, and training programs like the U.S. Food and Drug Administration. Such leadership would give authoritative guidance for countries in cooperation with national medical regulatory agencies, pharmaceutical companies, and international agencies, all of which have an urgent interest and investment in ensuring that patients throughout the world have access to good quality medicines. The organization would also advocate strongly for including targets for achieving good quality medicines in the United Nations Millennium Development Goals and Sustainable Development Goals.

Lessons learned from a review of interventions for adolescent and young key populations in Asia Pacific and opportunities for programming.

BACKGROUND: Over a third of new HIV infections globally are among 15-24 year-olds and over 20% among adolescents aged 10-19 years in Asia Pacific. The review was initiated to identify interventions in the region with demonstrated or potential impact for adolescent and young key populations (YKP) looking at the role of individual and structural factors in accessibility and delivery. The review is a component of a more comprehensive review undertaken by UNICEF and partners in the region. METHODS: This was a desk review of over 1000 articles, and 37 were selected. Journal articles in PubMed, Cochrane Library, Cochrane DARE, EMBASE, PsycINFO, CINAHL, and Web of Science databases were searched for HIV intervention-related information for adolescent and YKP. RESULTS AND DISCUSSION: Findings showed that except for low levels of risk perception, most individual decisions regarding safe behavior and testing uptake were mediated by structural factors. Critical enablers such as design and delivery of services, peer education, and condom policies were associated with the uptake of high-impact interventions. Synergistic development interventions such as sexuality education, rights-based enforcement of antitrafficking laws, and addressing violence and abuse could increase safer behaviors. CONCLUSIONS: Although structural factors play a key role in access and uptake of HIV prevention services for adolescent and YKP, further qualitative research is needed to understand and mitigate the drivers of vulnerability and constructed perceptions of risk.

Recent and potential developments in the analysis of urine: a review.

Analysis of urine is a widely used diagnostic tool that traditionally measured one or, at most, a few metabolites. However, the recognition of the need for a holistic approach to metabolism led to the application of metabolomics to urine for disease diagnostics. This review looks at various aspects of urinalysis including sampling and traditional approaches before reviewing recent developments using metabolomics. Spectrometric approaches are covered briefly since there are already a number of very good reviews on NMR spectroscopy and mass spectrometry and other spectrometries are not as highly developed in their applications to metabolomics. On the other hand, there has been a recent surge in chromatographic applications dedicated to characterising the human urinary metabolome. While developments in the analysis of urine encompassing both classical approaches of urinalysis and metabolomics are covered, it must be emphasized that these approaches are not orthogonal - they both have their uses and are complementary. Regardless, the need to normalise analytical data remains an important impediment.