Class of 2012 / Specific Aims: To evaluate the presence of statistical information from clinical studies in official product labeling specific for disease-modifying anti-rheumatic drugs (DMARDs) used in the treatment of rheumatoid arthritis. Methods: Data were abstracted from official product labeling DMARDs with FDA approval for treatment of rheumatoid arthritis. Each document was examined for the presence of statement regarding a priori type 1 error rate, p-values, and measures of variance. Medications were classified as either biologic or non-biologic. Main Results: A total of 14 DMARDs, 7 biologics (50%) and 7 non-biologics (50%), were found to be FDA approved for the treatment of rheumatoid arthritis. Primary outcomes consisted of American College of Rheumatology (ACR) response rates, radiographic changes, and health assessment questionnaire score (HAQ). Any measure of variance and the presence of a p-value were both found in six (43%) of the drug labels. Inclusion of p- values was found to be significantly greater in biologics compared to non-biologics for both ACR and radiographic results. Inclusion of variance was found to be significantly greater in biologics compared to non-biologics for radiographic changes only. No package inserts contained statements regarding the a priori type I error rate. Conclusions: Measures of variance are not frequently included in product labeling for either biologic or non-biologic DMARDs. However, inclusion of variance and p-values for ACR response rates and radiographic changes were more likely to be reported for biologics therapies as compared to non-biologics. A statement regarding Type 1 error rates were absent from labels regardless of outcome assessed.

The present thesis aims to explore and argue for an idea called Bilateral transition. Bilateral transition is based on the concepts of Corporate Social Responsibility (CSR) and sustainable consumption and relates to how organisations behind product labels develop their profiling of product labels in a Swedish context. The study is centred around three parts, each approaching the topic from a different angle: a historical angle, a contemporary angle and a future oriented angle. The first theme provides a historical context of different product labels found on the Swedish market. The second theme centres around a critical discourse analysis of market reports from the Swedish food label KRAV, with some quantitative elements incorporated, resulting in an analysis that addresses the change in profiling of Swedish product labels connected to sustainability and environment. The final theme is a qualitative analysis of quantitative data on consumer opinions concerning product labels in Sweden, based on an internship at Djurens Rätt. The latter study aims at investigating the perceived confusion surrounding product labelling and how transparency and a holistic profiling concerning sustainability might affect consumers. The final sub theme also addresses how emerging product labels can redirect their profiling towards producers and consumers. The final chapter contains a concluding discussion, where the results from the different parts have been compiled. The main result established in the thesis is that product labels (with focus on foods in Sweden) have undergone a transition in profiling, from focusing on one specific issue (e.g. organic farming), towards inclusion of a wider range of issues i.e. a holistic type of profiling towards sustainability. This might attract a broader target group of potential customers, in response to a broader societal focus on sustainability. The aim of the thesis has not been to draw any definite conclusions, but has rather been to make the present product label market in Sweden more comprehensive, by connecting the past, present and developing aspects of the topic of product labels in Sweden. The conclusion of the thesis has therefore resulted in establishing the idea of a bilateral transition in sustainability profiling on product labels in Sweden.