Provenance and Clinical Benefit of Medicines Introduced to the French Market, 2008 to 2018.

Importance: Both the commercial sector and academia play a vital role in medicine development. Ongoing debates exist on their contribution and the value of medicinal products entering the market. Objective: To identify the provenance and clinical benefit of medicines that entered the French market between 2008 and 2018. Design and Setting: In this cross-sectional study, the provenance of each medicine in the French market was established via a review of multiple sources documenting at least 2 matching findings per product. The clinical benefit was assigned using the matched scale developed from the Prescrire and Haute Autorité de Santé (HAS) gradings. The χ2 test was used to analyze the proportions and frequencies of medicines graded by Prescrire and HAS by origin, therapeutic category, and clinical benefit. Main outcomes and measures: The origins and therapeutic categories of medicines. Clinical benefit based on Prescrire and HAS grading. Concordance of Prescrire and HAS grading. Results: Of the 632 medicines that entered the French market between 2008 and 2018, 464 originated (73%) in the commercial sector, and 168 originated (27%) in the academic setting or in collaboration with commercial enterprises. Prescrire graded psychotropic agents (13/14 [93%]), whereas HAS graded respiratory agents (24/25 [96%]) as the highest percentage of medicines that provided no added benefit. Prescrire graded 360 medicines (77.6%) that originated in the industry and 108 medicines (64.3%) that originated in the academic setting (P = .001) to have no added clinical benefit. HAS assigned such grading to 331 ([71.3%] industry) vs 104 ([61.9%] academia) (P = .02). Based on the Prescrire grading, academia invented more medicines delivering some added benefit 57 (33.9%) vs 98 (21.1%) invented by industry (P = .001). HAS grading on some added benefit 51 ([30.4%] academia) vs 121 ([26.1%] industry) did not reach statistical significance (P = .29). However, HAS grading on substantial added clinical benefit reached statistical significance in favor of academia (13 [7.7%] vs 12 [2.6%] in the industry; P = .003), whereas Prescrire grading did not (1.8% academia vs 1.3% industry; P = .64). Conclusions and Relevance: More than 70% of medicines that entered the French market during the 10-year period originated in the commercial sector. Although most medicines were not graded as providing clinical benefit, medicines originating in the academic setting were more likely to be graded as conferring clinical benefit than those originating in the commercial setting.

The early impact of the global lockdown on post-secondary students and staff: A global, descriptive study.

OBJECTIVES: The aim of this study was to gain a preliminary, broad-level understanding of how the first lockdown impacted post-secondary students, faculty, and staff worldwide. METHODS: The data were obtained via a global online cross-sectional questionnaire survey using a mixed-method design and disseminated to university students, faculty, and staff from April to November 2020. The data were categorized in four themes/categories: (1) social life and relationships, (2) access to services, (3) health experiences, and (4) impact on mental health well-being. RESULTS: The survey included 27,804 participants from 121 countries and 6 continents. The majority of participants were from Europe (73.6%), female (59.2%), under 30 years of age (64.0%), living in large urban areas (61.3%), %), and from middle-income families (66.7%). Approximately 28.4% of respondents reported that the lockdown negatively impacted their social life, while 21.2% reported the lockdown had a positive impact. A total of 39.2% reported having issues accessing products or services, including essentials, such as groceries, or medical services. In addition, respondents reported an increase in stress and anxiety levels and a decrease in quality of life during the first 2 weeks of the lockdown. CONCLUSIONS: The COVID-19 pandemic and lockdown measures had an evident impact on the lives of post-secondary students, faculty, and staff. Further research is required to inform and improve policies to support these populations at both institutional and national levels.

Levels of Evidence within Cardiovascular Medicine Research in Saudi Arabia: A Systematic Review.

International commitments to reduce the prevalence of non-communicable disease have led the Government of Saudi Arabia to invest more in research related to cardiovascular disease. However, the strength of evidence derived from these research activities remains unclear. The aim of our study was to examine the level of evidence within clinical Cardiovascular Medicine research in Saudi Arabia. We conducted a systematic review of published articles that included a population from Saudi Arabia. Electronic databases EMBASE and MEDLINE (Ovid) were searched up to 25th of April 2021, supplemented by a second search in CENTRAL (Cochrane Central Register of Controlled Trials) and www.clinicaltrials.gov. In addition, the Snowball- and Pearl-growing methods of search were conducted for finding additional eligible articles. Finally, a search was conducted in PubMed database for all eligible articles published by Journal of the Saudi Heart Association from the first indexed issue up to April 2021. Level of evidence of reviewed articles was determined using the Oxford Level of Evidence 2 scale. We calculated the mean level of evidence over 5-year periods, and explored evidence for a time trend for number of published articles and LOE using linear regression. Of the 1113 records identified, 418 met the inclusion criteria for analysis. The articles were published between September 1986 and March 2021. More than half of the included articles were level IV studies (n = 242, 57.8%). Furthermore, we observed no trend over the years for increased mean of level of evidence (ß = -0.07, 95% CI [-0.20, -0.06], p = 0.236). Overall, the level of evidence produced by the articles in clinical Cardiovascular Medicine in Saudi Arabia is very low. Prioritizing higher-quality research is critical to produce the clinical practices and policies necessary to reduce the burden of cardiovascular diseases in Saudi Arabia.

Use of Paricalcitol as Adjunctive Therapy to Renin-Angiotensin-Aldosterone System Inhibition for Diabetic Nephropathy: A Systematic Review of the Literature.

PURPOSE: Diabetic nephropathy (DN) is a major complication of diabetes. Paricalcitol is a vitamin D analog that is typically used for secondary hyperparathyroidism in patients with chronic kidney disease but may have some beneficial effect on DN. This review evaluates the effect of paricalcitol in combination with renin-angiotensin-aldosterone system inhibitor therapy in managing DN. METHODS: A literature search was conducted of PubMed and ClinicalTrials.gov. Limits were set to include only clinical trials in humans written in English. The search terms used were paricalcitol and diabetic nephropathy. The following outcomes of kidney function and damage as well as adverse drug events were assessed and included: 24-h urine albumin excretion, serum phosphorus and calcium concentrations, urinary albumin excretion rates, estimated glomerular filtration rate, and markers of inflammation and endothelial function. FINDINGS: Four studies with a total of 389 patients were identified for review through the process described above. Two of the 6 studies provide evidence of the effect of paricalcitol on DN by way of reduction in urine albumin to creatinine ratio and urinary albumin excretion rate when compared with placebo. One study reported an increase in serum phosphorous, 1 study observed a decrease in estimated glomerular filtration rate, and 1 study reported no effect on inflammatory markers or endothelial function. IMPLICATIONS: The number of clinical trials examining the effect of paricalcitol in DN is small. The studies that have been completed enrolled <300 patients. Paricalcitol can reduce protein in the urine, but there is no compelling evidence that it preserves kidney function.