Capitalizing on Hope: Questionable Marketing Approval and Pricing of a New ALS Drug.

Regulatory agencies must balance patient demands to access new treatments for fatal diseases with limited treatment options while ensuring drug safety and efficacy. However, questionable U.S. regulatory actions resulted in the early approval of AMX0035 to treat amyotrophic lateral sclerosis (ALS) by reconvening advisory commissions to obtain positive decisions and designating the drug as a new molecular entity. Data from one randomized clinical trial suggests minimal delays in disease progression and longer survivability, but debate remains about the lack of confirmatory evidence of effectiveness owing to study limitations. A patient's decision-making process details the experience of using the drug, including perspectives on access, cost, effectiveness, and adverse effects. In line with the "nichebuster" business model, the drugmaker, Amylyx Pharmaceuticals, is charging US$158,000/year/patient and thus forecast to turn a profit on a drug with debatable clinical effectiveness prior to completing a Phase 3 trial. Early marketing approval, despite community demands, is unnecessary and may have reduced access because of the end of a compassionate use program, and the high price tag results in restricted coverage and high out-of-pocket costs. Also, the drug's key ingredients are available as a generic and a supplement.

The evil corporation master frame: The cases of vaccines and genetic modification.

Employing a qualitative content analysis of online comments made on YouTube and letters to the editor published in US newspapers, we examine the deployment and neutralization of the evil corporation master frame in debates on two distinct biotechnologies, vaccines and genetically modified organisms. This study builds on previous research by outlining three diagnostic components of the evil corporation master frame: dishonesty, greed, and the contamination of authority. It also finds that supporters of vaccines and genetically modified organisms seek to neutralize the evil corporation master frame through aggressive, defensive, endurance, and redemptive framings. This study provides ideational detail for the ways that controversial biotechnology is constructed. The particularly vexing anti-vaccine movement is not dissimilar from other challenges to mainstream science as disparate movements draw on the same master frame. It also demonstrates how defenses of genetically modified organisms and vaccines tend to reify the anti-corporate stigma that sustains challenges to scientific authority.

Children Receiving a Nutrition and High-Quality Early Childhood Education Intervention Are Associated with Greater Math and Fluid Intelligence Scores: The Guatemala City Municipal Nurseries.

Background: About 47% of children < 5 years of age are stunted in Guatemala. In this study, the investigators aimed to compare growth and cognitive outcomes between children in second grade that attended five Guatemala City Municipal Nurseries (GCMN) vs. same sex, grade, and age-matched children. Methods: A cross-sectional design nested in a retrospective cohort was implemented between 2015 and 2019. Children that attended the GCMN and matched controls completed a math test and validated receptive language and fluid intelligence tests. The primary caregivers completed a sociodemographic survey. General and generalized linear mixed effect models were used to compare children that attended the GCMN vs. controls. The models were adjusted by maternal education, sex, asset score, and other relevant covariates. Results: Children that attended the GCMN exhibited greater math and fluid intelligence scores relative to the controls in the adjusted models (ß = 6.48; 95% CI (2.35−10.61)) and (ß = 1.20; 95% CI (0.12−2.29)), respectively. Lower odds of stunting were significant for children who went to any early childcare institution (AOR = 0.28; 95% CI (0.09−0.89)). Conclusions: The importance of integrating nutrition and high-quality early childhood education interventions in cognitive and growth outcomes is highlighted in this study. The GCMN model may be a scalable model in similar low-resource settings.

Framing access to medicines during COVID-19: A qualitative content analysis of Gilead's Remdesivir.

The COVID-19 pandemic calls into question the institutional structure underlying the pharmaceutical industry. While some have called for medical technologies to be global public goods and patent waivers on pharmaceuticals, much of the industry has pushed back against any attempts that might threaten their monopoly power to set prices. Public acceptance of the role of private companies to control life-saving drugs, as well as of the intellectual property system, informs campaigns guaranteeing universal access to medicines and corporate strategies to shape policy. This study consists of a qualitative content analysis of online comments about news reports of Gilead Science's pricing of remdesivir, a re-purposed drug that shows some positive efficacy against COVID-19 in clinical trials. Analysing elite and public framing about medicine pricing informs our understanding of the social construction of markets. The findings identify hegemonic and counter-hegemonic discourse about innovation, affordability, saving lives, health care savings and international comparisons that stimulate debate and potentially advocacy. As such, the discursive context delineates the possibilities for remediating the normative and material structure of a pharmaceutical system currently geared towards private profit instead of public health needs.

Global capitalism as a societal determinant of health: A conceptual framework.

Recent scholarship has sought to distinguish between the deeper societal factors that shape the more proximate social determinants of health. One of these socio-structural institutions is global capitalism. While critical scholarship has advanced our understanding of the relationships between capitalist globalization and health, more work is needed to understand the transnational economic, political, and cultural practices that affect various global health issues. This paper argues that the theory of global capitalism provides an important, critical perspective for understanding different phenomena associated with global health. The theory's key concepts of transnational corporations, financialization, consumerism, transnational social classes, and transnational state comprise the conceptual framework. When applied to various global health topics, the theory advances our understanding of the health-related institutional structures of today's global economy, provides a holistic view that integrates various strands of health research, highlights various forms of health activism, and offers new questions for addressing persistent health injustice across the world.

A Survey of Texas HIV, Sexually Transmitted Disease, Tuberculosis, and Viral Hepatitis Providers' Billing and Reimbursement Capabilities.

The Affordable Care Act presents financial challenges and opportunities for publicly funded service providers. We assessed billing practices and anticipated barriers to third-party billing among organizations in Texas that provide publicly funded HIV, sexually transmitted diseases, tuberculosis, and viral hepatitis services. One third to one half of the organizations did not bill for medical services. The most common barrier to third-party billing was lack of staff knowledge about billing and coding. Future research must evaluate options for organizations and communities to maintain access to infectious disease services for vulnerable populations.