The will of #Congress? Permissive #regulation and the #strategic use of #labeling for the anti- #influenza #drug #Relenza (Soc Stud Sci., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Soc Stud Sci. 2019 Nov 19:306312719890015. doi: 10.1177/0306312719890015. [Epub ahead of print]

The will of Congress? Permissive regulation and the strategic use of labeling for the anti-influenza drug Relenza.

Mulinari S1, Davis C2.

Author information: 1 Department of Sociology, Lund University, Lund, Sweden. 2 Department of Global Health and Social Medicine, King’s College London, UK.

 

Abstract

Through an analysis of the FDA’s approval of the controversial anti-influenza drug Relenza (zanamivir), we interrogate distinct social scientific theories of pharmaceutical regulation. We investigate why, despite internal negative opinions and an Advisory Committee’s non-approval recommendation, the FDA approved Relenza in the late 1990s. Based on a close reading of FDA documents, we show how agency officials guided the manufacturer’s analyses and participated in constructing a tenuous argument for approval. We show how regulators may strategically design drug labels that can justify their permissive regulation. We consider the explanatory power of official accounts and alternative, partially overlapping, theories of pharmaceutical regulation in the Relenza case, and develop new insights into the institutional dynamics of regulator-industry relations. We find little or no evidence that the FDA was primarily driven by public health concerns, pressure from disease-based patient activism, or a consumerist and neoliberal regulatory logic, although some of these explanations provided managers with convenient rhetoric to rationalize their actions. Rather, we argue that the Relenza case highlights contradictions between a scientific culture at FDA, conducive to rigorous product evaluations, and the agency’s attempts to accommodate higher-level political (i.e. Congress) and industry demands conducive of permissive regulation – consistent with some aspects of reputational and capture theories, as well as with corporate bias theory.

KEYWORDS: Food and Drug Administration; corporate bias; influenza; pharmaceutical industry; regulation; regulatory capture

PMID: 31739775 DOI: 10.1177/0306312719890015

Keywords: Society; Politics; Public Health; USA.

——

The #publichealth #crisis of #underimmunisation: a global plan of action (Lancet Infect Dis., summary)

[Source: The Lancet Infectious Diseases, full page: (LINK). Abstract, edited.]

The public health crisis of underimmunisation: a global plan of action

Prof Lawrence O Gostin, JD, Prof James G Hodge Jr, JD, Prof Barry R Bloom, MD, Ayman El-Mohandes, MD, Prof Jonathan Fielding, MD, Prof Peter Hotez, MD, Dean Ann Kurth, PhD, Prof Heidi J Larson, PhD, Prof Walter A Orenstein, Kenneth Rabin, PhD, Prof Scott C Ratzan, MD, Prof Daniel Salmon, PhD

Published: November 06, 2019 / DOI: https://doi.org/10.1016/S1473-3099(19)30558-4

 

Summary

Vaccination is one of public health’s greatest achievements, responsible for saving billions of lives. Yet, 20% of children worldwide are not fully protected, leading to 1·5 million child deaths annually from vaccine-preventable diseases. Millions more people have severe disabling illnesses, cancers, and disabilities stemming from underimmunisation. Reasons for falling vaccination rates globally include low public trust in vaccines, constraints on affordability or access, and insufficient governmental vaccine investments. Consequently, an emerging crisis in vaccine hesitancy ranges from hyperlocal to national and worldwide. Outbreaks often originate in small, insular communities with low immunisation rates. Local outbreaks can spread rapidly, however, transcending borders. Following an assessment of underlying determinants of low vaccination rates, we offer an action based on scientific evidence, ethics, and human rights that spans multiple governments, organisations, disciplines, and sectors.

Keywords: Vaccines; Society; Politics; Public Health.

—–

#US #sanctions in #Venezuela: #help, hindrance, or #violation of #humanrights? (Lancet, summary)

[Source: The Lancet, full page: (LINK). Summary, edited.]

US sanctions in Venezuela: help, hindrance, or violation of human rights?

Tanya L Zakrison, Carles Muntaner

Published: June 13, 2019 / DOI: https://doi.org/10.1016/S0140-6736(19)31397-2

___

We read with interest the Review about Venezuela’s public health crisis1 and could not agree more emphatically with the authors. However, the root causes of this economic crisis, specifically, the impact of the US economic sanctions, deserve further inquiry. Since 2014, 43 unilateral, coercive measures have been applied against Venezuela by the US Administration. These have effectively paralysed the economy, blocked oil exportation globally, and frozen Venezuelan financial assets abroad while denying access to international financial systems. This loss in oil revenue and assets has amounted to a shortfall worth billions of US dollars, prohibiting the importation of essential, lifesaving products.

(…)

___

We declare no competing interests.

Keywords: Public Health; Venezuela; USA; Wars; Politics; Society; Poverty.

——

#Refugee and #migrant #health in the #European Region (Lancet, summary)

[Source: The Lancet, full page: (LINK). Summary, edited.]

Refugee and migrant health in the European Region

Ryoko Takahashi, Krista Kruja, Soorej Jose Puthoopparambil, Santino Severoni

Published: May 20, 2019 / DOI: https://doi.org/10.1016/S0140-6736(19)30282-X

___

WHO is the respected authority in leading the production and use of core evidence for public health decision making.1 The Health Evidence Network (HEN) is an information service for public health decision makers in the WHO European Region and supports them to use the best available evidence.

(…)

We declare no competing interests.

___

Article Info

Published: May 20, 2019

Identification: DOI: https://doi.org/10.1016/S0140-6736(19)30282-X

Copyright © 2019 Elsevier Ltd. All rights reserved.

Keywords: Migrants; Society; Politics; European Region; Public Health.

——

#Privatisation of #immigration #detention facilities (Lancet, summary)

[Source: The Lancet, full page: (LINK). Summary, edited.]

Privatisation of immigration detention facilities

Altaf Saadi, Lello Tesema

Published: May 20, 2019 / DOI: https://doi.org/10.1016/S0140-6736(19)30351-4

___

In December, 2018, two Guatemalan children, a 7-year-old girl and an 8-year-old boy, died while detained in immigration custody in the USA. Their tragic deaths should raise alarm about the dangerously substandard medical and mental health care at US immigration detention facilities.

(…)

We declare no competing interests.

___

Article Info

Published: May 20, 2019

Identification: DOI: https://doi.org/10.1016/S0140-6736(19)30351-4

Copyright © 2019 Elsevier Ltd. All rights reserved.

Keywords: USA; Society; Politics; Migrants; Racism; Public Health.

—–

#Immigration in #Italy: the #medical #community’s role in #human #rights (Lancet, summary)

[Source: The Lancet, full page: (LINK). Summary, edited.]

Immigration in Italy: the medical community’s role in human rights

Raffaella Casolino

Published: May 20, 2019 / DOI: https://doi.org/10.1016/S0140-6736(19)30216-8

___

Italy has been witnessing a rapid escalation towards racism and xenophobia since the new government came into power in June, 2018. On Nov 27, 2018, the lower house of the Italian Parliament approved the Decree-Law on Immigration and Security, which includes measures that would abolish humanitarian protection status for migrants, block asylum seekers from accessing reception centres focusing on social inclusion, and extend the duration of detention in return centres and hotspots. These measures fundamentally undermine international human rights principles. The day after approval, the Deputy Prime Minister and Minister of the Interior declared that Italy would not sign the UN Global Compact for Safe, Orderly and Regular Migration or take part in an intergovernmental conference in Marrakech, Morocco, on Dec 10, 2018.

(…)

I declare no competing interests.

___

 

Reference

UN Human Rights, Office of the high commissioner. Legal changes and climate of hatred threaten migrants’ rights in Italy, say UN experts. URL: https://www.ohchr.org/en/NewsEvents/Pages/DisplayNews.aspx?NewsID=23908&LangID=E | Date: Nov 21, 2018 | Date accessed: November 28, 2018

 

Article Info

Published: May 20, 2019

Identification: DOI: https://doi.org/10.1016/S0140-6736(19)30216-8

Copyright © 2019 Elsevier Ltd. All rights reserved.

Keywords: Public Health; Society; Politics; Italy; Migrants; Racism.

—–

The #UCL – #Lancet #Commission on #Migration and #Health: the health of a world on the move (Lancet, abstract)

[Source: The Lancet, full page: (LINK). Abstract, edited.]

The UCL–Lancet Commission on Migration and Health: the health of a world on the move

Prof Ibrahim Abubakar, FRCP  *, Robert W Aldridge, PhD *, Delan Devakumar, PhD *, Miriam Orcutt, MSc *, Rachel Burns, MSc, Prof Mauricio L Barreto, MD, Poonam Dhavan, MPH, Fouad M Fouad, MD, Prof Nora Groce, PhD, Prof Yan Guo, PhD, Sally Hargreaves, FRCPE, Michael Knipper, MD, Prof J Jaime Miranda, MD, Prof Nyovani Madise, PhD, Prof Bernadette Kumar, DrPhilos, Davide Mosca, MD †, Prof Terry McGovern, JD, Leonard Rubenstein, LLM, Prof Peter Sammonds, PhD, Prof Susan M Sawyer, MD, Kabir Sheikh, PhD, Prof Stephen Tollman, PhD, Prof Paul Spiegel, MD, Prof Cathy Zimmerman, PhD * on behalf of theUCL–Lancet Commission on Migration and Health ‡

Published: December 05, 2018 / DOI: https://doi.org/10.1016/S0140-6736(18)32114-7

 

Abstract

With one billion people on the move or having moved in 2018, migration is a global reality, which has also become a political lightning rod. Although estimates indicate that the majority of global migration occurs within low-income and middle-income countries (LMICs), the most prominent dialogue focuses almost exclusively on migration from LMICs to high-income countries (HICs). Nowadays, populist discourse demonises the very same individuals who uphold economies, bolster social services, and contribute to health services in both origin and destination locations. Those in positions of political and economic power continue to restrict or publicly condemn migration to promote their own interests. Meanwhile nationalist movements assert so-called cultural sovereignty by delineating an us versus them rhetoric, creating a moral emergency.

Keywords: Migrants; Society; Public Health.

——