Generating pathways to domestically sourced plasma-derived medicinal products: Report from a workshop by the International Plasma and Fractionation Association and the Working Party on Global Blood Safety of the International Society of Blood Transfusion.

Plasma-derived medicinal products (PDMPs) are recognized internationally as essential medicines required to treat various acute and chronic conditions including congenital deficiencies of plasma proteins in haemophilia and primary immune deficiency. Global provision of these medicines is dominated by a small number of commercial companies, influencing the price and availability of the products. Achieving a level of strategic independence from this dominance is now seen as a public health priority in many countries. During the Regional Congress of the International Society for Blood Transfusion (ISBT) in Cape Town, South Africa, in November 2023, around 50 delegates from 24 countries participated in a workshop (WS) organized jointly by the International Plasma and Fractionation Association (IPFA) and the ISBT Working Party on Global Blood Safety on pathways towards provision of PDMPs from domestic plasma independent of commercial purchase in the open market. The WS was structured around three themes, each addressed by a separate group: Quality/safety requirements for plasma for fractionation (PfF) Stepwise access for safe plasma proteins Approaching contract fractionation A synthesis of conclusions from these groups included the following: The need to acquire support from government authorities for a national plasma policy, recognizing the difficulties posed by unstable political and bureaucratic environments. The value of embedding plasma and PDMPs within a patient blood management (PBM) paradigm to promote optimal clinical use of PDMPs. Training of blood/plasma collection personnel in the relevant principles of Good Manufacturing Practice (GMP), coupled with regulatory oversight of plasma product production in the engaged jurisdictions. Appreciation that limited access to contract fractionation may necessitate a stepwise approach, which may include small-scale preparation of versions of essential plasma proteins as an intermediate phase towards the manufacture of industrial-scale PDMPs from domestic plasma.

Critical appraisal training increases understanding and confidence and enhances the use of evidence in diverse categories of learners.

BACKGROUND: Training in evidence-based medicine is most commonly offered to physicians, medical students and health-care decision-makers. SETTING AND PARTICIPANTS: We partnered with community organizations to recruit participants and develop trainings for consumers, non-physician health-care providers and journalists in California. INTERVENTION: We conducted half-day and one-day workshops in critical appraisal of health evidence. Workshops consisted of didactic presentations, small-group practice sessions and class discussions. OUTCOME MEASURES: We measured knowledge and confidence immediately before and after the workshops and at follow-up 6 months later. We also asked participants to describe their use of health evidence before the workshops and at follow-up. RESULTS: At baseline, 41% of the consumers, 45% of the providers and 57% of the journalists correctly answered questions about health evidence. Scores increased by about 20% (P < 0.05) in all groups at the end of the workshops and remained significantly over baseline at follow-up. At baseline, 26% of the participants were confident in their understanding of critical appraisal concepts, significantly increasing to 54% after the workshops and sustained (53%) at follow-up. During discussions, participants' comments often focused on funding and the potential effects of financial conflicts of interest on study findings. Participants did not use evidence more frequently at follow-up but said that they applied workshop skills in evaluating research, communicating with others and making decisions about health care. CONCLUSION: It is possible to successfully conduct critical appraisal workshops to aid health-related decision making for groups who have previously not had access to this kind of training.

The Influence of the Breast on Physical Activity Participation in Females.

BACKGROUND: The importance of physical activity is well known. However, previous research suggests that breast movement during exercise can be painful, embarrassing, and anecdotally deter exercise participation. Therefore, this research investigates whether the breast influences physical activity participation. METHODS: Female respondents (n = 249) completed a breast health and physical activity survey assessing bras and bra fit, physical activity, breast pain, comments and improvements, breast history, and demographics. RESULTS: Results found that the breast was a barrier to physical activity participation for 17% of women. "I can't find the right sports bra" and "I am embarrassed by excessive breast movement" were the most influential breast related barriers to activity. Breast pain increased with vigorous activity and poor breast support. Breast health knowledge increased the use of a sports bra and levels of physical activity. CONCLUSIONS: The breast was the fourth greatest barrier to physical activity, behind energy/motivation (first), time constraints (second), and health (third), despite its omission from previous physical activity literature. As 33% of women were not meeting physical activity guidelines, increasing breast health knowledge may reduce barriers to physical activity.

The cycle of bias in health research: a framework and toolbox for critical appraisal training.

Recognizing bias in health research is crucial for evidence-based decision making. We worked with eight community groups to develop materials for nine modular, individualized critical appraisal workshops we conducted with 102 consumers (four workshops), 43 healthcare providers (three workshops), and 33 journalists (two workshops) in California. We presented workshops using a "cycle of bias" framework, and developed a toolbox of presentations, problem-based small group sessions, and skill-building materials to improve participants' ability to evaluate research for financial and other conflicts of interest, bias, validity, and applicability. Participant feedback indicated that the adaptability of the toolbox and our focus on bias were critical elements in the success of our workshops.

Moral disengagement in the corporate world.

We analyze mechanisms of moral disengagement used to eliminate moral consequences by industries whose products or production practices are harmful to human health. Moral disengagement removes the restraint of self-censure from harmful practices. Moral self-sanctions can be selectively disengaged from harmful activities by investing them with socially worthy purposes, sanitizing and exonerating them, displacing and diffusing responsibility, minimizing or disputing harmful consequences, making advantageous comparisons, and disparaging and blaming critics and victims. Internal industry documents and public statements related to the research activities of these industries were coded for modes of moral disengagement by the tobacco, lead, vinyl chloride (VC), and silicosis-producing industries. All but one of the modes of moral disengagement were used by each of these industries. We present possible safeguards designed to protect the integrity of research.

Tobacco industry research and protection of human subjects: a case study of R. J. Reynolds.

Companies that conduct research are under no obligation to follow guidelines regarding treatment of human subjects in clinical trials. By contrast, clinical researchers funded by federal agencies or under U.S. Food and Drug Administration authority are required to follow federal regulations, and academics must adhere to their institutions' standards. We examined how one tobacco company, R. J. Reynolds, treated human subjects in internal research conducted from 1985 to 2000. We then compared this treatment with standards of the time. We focused on R. J. Reynolds because the company conducted a significant amount of research using human subjects. Tobacco industry documents were retrieved from the UCSF/Legacy Tobacco Documents Library, Tobacco Documents Online, and industry Web sites. Materials from 73 research projects, including informed consent forms, were analyzed. The U.S. Code of Federal Regulations, Title 45 Part 46, Protection of Human Subjects (the Common Rule) was the primary source for human subjects research guidelines and standards. R. J. Reynolds formed a human subjects review committee in 1985. The committee's structure and procedures did not meet generally accepted practices of the time regarding community representation, written procedures for adverse events, and other factors. In all 73 studies, consent procedures failed to meet five or more human subjects research standards. Policymakers should consider expanding the scope of federal human subjects research regulations to cover research undertaken by private firms such as tobacco companies.

Public health under attack: the American Stop Smoking Intervention Study (ASSIST) and the tobacco industry.

We describe the tobacco industry's response to the American Stop Smoking Intervention Study (ASSIST). Tobacco industry documents from the University of California, San Francisco/Legacy Tobacco Documents Library and industry Web sites were analyzed. LexisNexis and the Library of Congress's Thomas Web site were searched for legislative history. We found that the tobacco industry considered ASSIST a major threat because of its emphasis on policy and creation of local tobacco control infrastructures. The industry mobilized resources for a well-coordinated attack on ASSIST. Although industry executives were sometimes frustrated in their efforts, they ultimately had a chilling effect on ASSIST. This evidence suggest that tobacco control advocates should expect a vigorous response from the tobacco industry to policy advocacy efforts, particularly at the local level.