Both the commentary from Elias et al, “Quality and safety for substances of human origins: scientific evidence and the new EU regulations”, and the response to that commentary from Domínguez-Gil et al, recently published in BMJ Global Health (1) caught our attention. The response from Domínguez-Gil et al eloquently explains the recommitment to the principle of voluntary and unpaid donation in the new SoHO Regulation(2) and comprehensively addresses several statements in the commentary from Elias et al which required clarification. Some additional items in the commentary are addressed here.
The commentary states that “in Europe, countries allowing monetary compensation for donors are the only ones achieving self-sufficiency in plasma collection for the production of immunoglobulin.’ While four countries collect more plasma than they theoretically need to meet their patients’ current needs (Austria, Czechia, Germany, and Hungary) the finished plasma-derived medicines, including Immunoglobulins, are dispatched to those countries where the company markets these products, independently from the origin of the plasma.(3,4) Czechia is noteworthy because its blood and plasma collection systems generate the highest per capita collection globally,(5) including a high volume of plasma collected in public hospitals. Concurrently, immunoglobulin provision in this same country is below half of the average per capita usage for this product across the EU, and yet...
Both the commentary from Elias et al, “Quality and safety for substances of human origins: scientific evidence and the new EU regulations”, and the response to that commentary from Domínguez-Gil et al, recently published in BMJ Global Health (1) caught our attention. The response from Domínguez-Gil et al eloquently explains the recommitment to the principle of voluntary and unpaid donation in the new SoHO Regulation(2) and comprehensively addresses several statements in the commentary from Elias et al which required clarification. Some additional items in the commentary are addressed here.
The commentary states that “in Europe, countries allowing monetary compensation for donors are the only ones achieving self-sufficiency in plasma collection for the production of immunoglobulin.’ While four countries collect more plasma than they theoretically need to meet their patients’ current needs (Austria, Czechia, Germany, and Hungary) the finished plasma-derived medicines, including Immunoglobulins, are dispatched to those countries where the company markets these products, independently from the origin of the plasma.(3,4) Czechia is noteworthy because its blood and plasma collection systems generate the highest per capita collection globally,(5) including a high volume of plasma collected in public hospitals. Concurrently, immunoglobulin provision in this same country is below half of the average per capita usage for this product across the EU, and yet Czech patients have experienced shortages of the plasma-derived medicines they require.(4) The overcollection of plasma for fractionation in countries that allow monetary compensation for donors uncovers such a system's commercial nature and is unrelated to self-sufficiency.
Related to this, the Regulation references public voluntary and unpaid plasma (and other SoHO) collection programmes proving more resilient than paid-plasma collection programmes during crises. (2,4,6) The provisions in the Regulation to strengthen the continuity of supply of plasma, and other critical SoHO, at national level urge Member States to increase their collection capacity and donor base for plasma by developing non-profit and public plasmapheresis programmes. These provisions, and the intended contribution to European self-sufficiency, are therefore timely and appropriate.
Elias et al argue that donor compensation does not impact the quality and safety of blood and blood components. However, remunerated blood donors have a higher risk of blood-borne infectious diseases than voluntary non-remunerated donors.(5,7,8) As testing for pathogens or pathogen reduction methods are not entirely fail-proof, collecting blood for blood components from voluntary non-remunerated donors remains an important additional safety measure. Furthermore, by facilitating high frequency plasma donation, remuneration contributes to the collection of plasma with lesser immunoglobulin content.(9)
Regarding the timeline ahead, echoing Domínguez-Gil et al, following the recent approval in the European Parliament and adoption by the Council, the new Regulation will shortly be published in the Official Journal of the EU and enter into force a few days later. All this is expected to happen before the end of June 2024. The Regulation will then apply as from mid-2027, 3 years after its publication and entry into force, with an extra year for certain provisions.
We agree with Elias et al’s statement that ‘the ultimate objective should not merely be self-sufficiency but ensuring the availability of safe, sufficient, and accessible SoHOs for all in need.’ We believe that the SoHO Regulation meets its objective of establishing measures that set high standards of quality and safety for all SoHO. Further, when aligned with national commitments to collect adequate plasma volumes which are backed by legislative control over the plasma value chain, the Regulation will contribute to the optimum availability of plasma medicines for patients in Europe and will strengthen Europe’s ability to work with other global regions on ensuring patients there also have their plasma-derived medicine needs met.
Authors
Peter O'Leary (0009-0009-3729-6080)1, Bernardo Rodrigues (0009-0003-7383-775X)1, Pierre Tiberghien (0000-0002-9310-8322) 1 ,Dragoslav Domanović (0000-0001-9696-8953) 1
References
1. Elias, J.J., Lacetera, N., Macis, M., Ockenfels, A. and Roth, A.E., 2024. Quality and safety for substances of human origins: scientific evidence and the new EU regulations. BMJ Global Health, 9(4).
2. Regulation of the European Parliament and of The Council on Standards of Quality and Safety for Substances of Human Origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC https://data.consilium.europa.eu/doc/document/PE-8-2024-INIT/en/pdf
3. Bolcato, M. and Jommi, C., 2024. Shortage of plasma-derived medicinal products: what is next? narrative literature review on its causes and counteracting policies in Italy. Frontiers in Pharmacology, 15, p.1375891.
4. Data & Analysis Of Immunoglobulin Supply And Plasma Requirements In Europe 2010-2021, Marketing Research Bureau, 2023 https://marketingresearchbureau.com/wp-content/uploads/2023/05/MRB_EU_SO...
5. Turek P, Řeháček V. Plasma Collection and PDMP Supply in The Czech Republic. 2022. www.centronazionalesangue.it/wp-content/uploads/2022/05/20.-Dr-Rehacek.pdf
6. Covington, M.L., Voma, C. and Stowell, S.R., 2022. Shortage of plasma-derived products: a looming crisis?. Blood, The Journal of the American Society of Hematology, 139(21), pp.3222-3225.
7. Van der Poel, C.L., Seifried, E. and Schaasberg, W.P., 2002. Paying for blood donations: still a risk?. Vox sanguinis, 83(4), pp.285-293.8
8. Kalibatas, V. and Kalibatienė, L., 2022. Reducing the risk of transfusion-transmitted infectious disease markers in blood and blood component donations: Movement from remunerated to voluntary, non-remunerated donations in Lithuania from 2013 to 2020. PLoS One, 17(11), p.e0277650.
9. SUPPLY 2024: Recommendations report on plasma donation quality. Available at https://supply-project.eu/wp-content/uploads/2024/02/D3.6-Recommendation...
I write to offer a critical evaluation of the thought-provoking article titled "Capitalogenic Disease: Social Determinants in Focus" by [Author's Name] in [Journal Name]. This article sheds light on the impact of capitalism on health outcomes and proposes the term "capitalogenic disease" as an analytical framework to examine the adverse effects of the capitalist system on public health. While the article presents compelling arguments, it is important to critically explore certain aspects to expand the discourse on this subject.
The author rightly emphasizes the significance of understanding the specific political and economic systems within the broader context of social determinants of health. By focusing on capitalism and its associated dynamics of capital accumulation, the article draws attention to the root causes of health disparities and highlights the prioritization of profits and growth over human well-being. This perspective offers valuable insights into the harmful influence of commercial determinants, patent regimens, poverty, and unequal access to healthcare.
Moreover, the article rightly identifies the impact of capitalism on marginalized communities, particularly in the global South. By relying on historical evidence and contemporary examples, such as the tobacco and food industries' unethical practices, the article underscores the importance of addressing structural factors and power imbalances to tackle health ineq...
I write to offer a critical evaluation of the thought-provoking article titled "Capitalogenic Disease: Social Determinants in Focus" by [Author's Name] in [Journal Name]. This article sheds light on the impact of capitalism on health outcomes and proposes the term "capitalogenic disease" as an analytical framework to examine the adverse effects of the capitalist system on public health. While the article presents compelling arguments, it is important to critically explore certain aspects to expand the discourse on this subject.
The author rightly emphasizes the significance of understanding the specific political and economic systems within the broader context of social determinants of health. By focusing on capitalism and its associated dynamics of capital accumulation, the article draws attention to the root causes of health disparities and highlights the prioritization of profits and growth over human well-being. This perspective offers valuable insights into the harmful influence of commercial determinants, patent regimens, poverty, and unequal access to healthcare.
Moreover, the article rightly identifies the impact of capitalism on marginalized communities, particularly in the global South. By relying on historical evidence and contemporary examples, such as the tobacco and food industries' unethical practices, the article underscores the importance of addressing structural factors and power imbalances to tackle health inequalities and social injustices.
However, it is important to recognize that the analysis presented in the article does not encompass all social and structural determinants of disease. Alternative political-economic systems may also contribute to health disparities, and their examination should not be overlooked. We should strive for an inclusive understanding of various systems and their impacts on public health.
While the concept of capitalogenic disease opens new avenues for research and understanding, it is crucial to acknowledge that the proposed framework is not without limitations. The article does not extensively discuss potential solutions or practical implementation strategies to counteract the adverse effects of capitalism on health outcomes. Including actionable recommendations, policies, or case studies of successful interventions would further enrich the article's contribution to the field.
In conclusion, the article "Capitalogenic Disease: Social Determinants in Focus" provides a significant perspective by highlighting the role of capitalism in shaping health outcomes. Its emphasis on the need for a postcapitalist economic system and universal access to essential goods and services deserves attention. However, a comprehensive analysis requires considering alternative political-economic systems and providing practical recommendations for addressing the identified issues. By expanding the scope of research, engaging in productive dialogue, and advocating for transformative solutions, we can collectively strive to improve global health equity.
Unveiling Oversights and Underreporting: A Rebuttal of Sri Lanka's COVID-19 Response Analysis
Abstract
In response to an analysis of Sri Lanka's COVID-19 handling , this rebuttal delves into critical deficiencies in the data used and contextual factors influencing governmental decisions. It presents objective data showing Sri Lanka's poor performance in managing COVID-19 despite its healthcare infrastructure advantages. The initial success is attributed more to political motivations surrounding parliamentary elections rather than effective public health measures. Ethnoreligious stigmatisation exacerbated the crisis, impacting testing efforts and vaccination uptake, while economic mismanagement further worsened the situation, leading to the ousting of the Executive President in 2022. This rejoinder criticises the article for not explicitly recognising or downplaying these factors' significance. It concludes that while the study contributes to the lessons to be learned for the management of future pandemics in Sri Lanka, it overlooks crucial aspects, potentially skewing lessons for the future. Due to brevity of space, we are unable to publish our entire rejoinder, including the data table, which could be obtained from the corresponding author of this rejoinder.
Introduction
Acknowledging the exhaustive analysis by the authors regarding Sri Lanka's responses to and management of COVID-19, this rebuttal endeavours to shed li...
Unveiling Oversights and Underreporting: A Rebuttal of Sri Lanka's COVID-19 Response Analysis
Abstract
In response to an analysis of Sri Lanka's COVID-19 handling , this rebuttal delves into critical deficiencies in the data used and contextual factors influencing governmental decisions. It presents objective data showing Sri Lanka's poor performance in managing COVID-19 despite its healthcare infrastructure advantages. The initial success is attributed more to political motivations surrounding parliamentary elections rather than effective public health measures. Ethnoreligious stigmatisation exacerbated the crisis, impacting testing efforts and vaccination uptake, while economic mismanagement further worsened the situation, leading to the ousting of the Executive President in 2022. This rejoinder criticises the article for not explicitly recognising or downplaying these factors' significance. It concludes that while the study contributes to the lessons to be learned for the management of future pandemics in Sri Lanka, it overlooks crucial aspects, potentially skewing lessons for the future. Due to brevity of space, we are unable to publish our entire rejoinder, including the data table, which could be obtained from the corresponding author of this rejoinder.
Introduction
Acknowledging the exhaustive analysis by the authors regarding Sri Lanka's responses to and management of COVID-19, this rebuttal endeavours to shed light on significant deficiencies in the objective data utilised and the contextual factors influencing specific governmental decisions. Through this endeavour, our aim is to offer a more profound and nuanced comprehension of the underlying causes and repercussions of COVID-19 mismanagement in Sri Lanka.
Our response enhances the ongoing discourse initiated by the authors and adds to the global body of literature concerning COVID-19.
Lack of objective data
Sri Lanka initially stood out as a success story in South Asia during the early stages of the pandemic in 2020.
The factual data compiled and presented by the authors of this rebuttal confirms that Sri Lanka ranked as the poorest performer in South Asia concerning COVID-19-related deaths per million people between January 2020 and December 2022 (see table). Specifically, Sri Lanka recorded 779 deaths per million, topping the list, followed by the Maldives with 622, India with 377, Nepal with 369, Afghanistan with 192, Bangladesh with 175, Pakistan with 133, and Bhutan with 26. The average number of COVID-19 deaths per million across South Asia stood at 330, significantly lower than Sri Lanka's figure (779) (see table).
Additionally, regarding COVID-19 cases/incidences per million, the Maldives reported the highest figure (371,356) during the same three-year period, trailed by Bhutan with 78,155, Nepal with 33,146, India with 31,764, Sri Lanka with 31,106, Bangladesh with 12,133, Pakistan with 6,866, and Afghanistan with 5,088. The average incidence of COVID-19 infection per million across South Asia was 26,567, notably lower than Sri Lanka's figure (31,764) (see table).
These objective statistics highlight a concerning trend: despite Sri Lanka and the Maldives boasting the highest levels of human development in South Asia according to the United Nations Human Development Index (UNHDI) in 2021 —0.783 for Sri Lanka and 0.753 for the Maldives—they experienced the highest number of COVID-19 deaths and cases/incidences, respectively. Moreover, both countries possess relatively robust healthcare systems and infrastructure. For instance, Sri Lanka boasts a hospital bed capacity of 4.2 beds per 1000 people, compared to the average of 2.3 beds in middle-income countries and a mere 0.6 beds in South Asian countries, as reported by the original authors. Yet, despite these advantages, Sri Lanka fared poorly in handling the pandemic compared to other South Asian nations.
Moreover, the total blackout of the number of deaths caused by COVID-19 is another major flaw in the study by the authors.
Conclusion
The conclusion drawn from this rebuttal is that while the study by the original authors offers considerable contributions to the future management of pandemics in Sri Lanka, it fails to adequately address certain critical factors or events. This oversight and underreporting may have skewed the lessons that could be gleaned for the future.
References & Endnotes
Rannan-Eliya RP, Ghaffoor A, Amarasinghe S, et al. Sri Lanka’s COVID- 19 response and maintaining health services: implications for future pandemics. BMJ Global Health, 2024;8:e013286. doi:10.1136/ bmjgh-2023-01328
Amaratunga, D., Fernando, N., Haigh, R., & Jayasinghe, N. (2020). The COVID-19 outbreak in Sri Lanka: A synoptic analysis focusing on trends, impacts, risks and science-policy interaction processes. Progress in Disaster Science, 8, 100133. https://doi.org/10.1016/j.pdisas.2020.100133
Rajapaksa L, De Silva P, Abeykoon A, Somatunga L, Sathasivam S, Perera S et al., 2021, Sri Lanka health system review. New Delhi (India): World Health Organization Regional Office for South-East Asia. https://iris.who.int/bitstream/handle/10665/342323/9789290228530-eng.pdf... accessed on May 05, 2024.
Prompted by a BMJ publications email to look at this recent editorial in BMJ Global Health, as someone with a lifelong career as a self styled “Field Epidemiologist”, my interest was instantly piqued by its title (1). It and the supporting Medical Anthropology Quarterly article(2) that it drew heavily upon did not disappoint. It’s a stimulating read that all of us in the field would do well to reflect on.
Even in a career carried out almost exclusively in the developed country setting of the UK, I encountered “organizational features of hypothesis building”, “structural bias”, that resulted in error. Initial reluctance to acknowledge the zoonotic potential of Bovine Spongiform Encephalopathy (BSE) was prompted in part by the success of the emerging science of molecular genetics in explaining clusters in other countries. In 1995, one acknowledged global expert published a BMJ education and debate piece, implying that a consequence of such suggestions of zoonotic spread, even in the face of emerging evidence, might be, “a class action suit for anxiety brought by the entire British population against its own government” (3) although he did have the grace subsequently to acknowledge his error (4). In the recent international outbreak of hepatitis of unknown cause, viral explanations have predominated (5), even though the epidemiological pattern is more suggestive of a toxin as a cause (6).
My colleagues and I might be characterised, I suppose, as "elite...
Prompted by a BMJ publications email to look at this recent editorial in BMJ Global Health, as someone with a lifelong career as a self styled “Field Epidemiologist”, my interest was instantly piqued by its title (1). It and the supporting Medical Anthropology Quarterly article(2) that it drew heavily upon did not disappoint. It’s a stimulating read that all of us in the field would do well to reflect on.
Even in a career carried out almost exclusively in the developed country setting of the UK, I encountered “organizational features of hypothesis building”, “structural bias”, that resulted in error. Initial reluctance to acknowledge the zoonotic potential of Bovine Spongiform Encephalopathy (BSE) was prompted in part by the success of the emerging science of molecular genetics in explaining clusters in other countries. In 1995, one acknowledged global expert published a BMJ education and debate piece, implying that a consequence of such suggestions of zoonotic spread, even in the face of emerging evidence, might be, “a class action suit for anxiety brought by the entire British population against its own government” (3) although he did have the grace subsequently to acknowledge his error (4). In the recent international outbreak of hepatitis of unknown cause, viral explanations have predominated (5), even though the epidemiological pattern is more suggestive of a toxin as a cause (6).
My colleagues and I might be characterised, I suppose, as "elite", though, were we also “outsiders”, albeit national rather than international? We had ongoing relationships over many years with the local public health teams that we supported. Our contribution, in my experience, in the time of outbreaks and other crises, was to empower local teams to help dispel “uncertainty absorption” often by facilitating relatively straightforward epidemiological practices; workable case definitions, a definitive line listing, descriptive case characterisation (time/place/person). At the time that I commenced my public health career in the early 1980s, experience of these approaches, having been largely absent from general UK public and environmental health training, was not widespread. By the time I retired in 2013, due in part to a considerable effort put into supporting the training of Environmental Health Officers and Masters students in public health, this was no longer the case. We were, indeed, more experienced in scientific publication and encouraged it, not least for the discipline that it brings. As such, constrained by the format, we may have been guilty of making an overly coherent (although ultimately truthful) presentation of “piecemeal activities”; “a nice story of a nice thing”. Local colleagues, on the other hand, were nearly always involved in authorship.
If I have an attachment to the term “Field Epidemiologist” and indeed, “Disease Detective”, it is because these terms usefully differentiate the practice of intervention epidemiology from computer modelling, a metier that, in the UK at least, has almost entirely arrogated the term “epidemiologist”. These epidemiologists, more quants than detectives, are not usually deployed even for two weeks and inevitably, therefore, have none of the “proximity to suffering” that may or may not inspire meaningful action and intervention. The pre-dominance of this cadre of mathematical modellers has, on several occasions, prompted public health actions that have proved themselves to be of doubtful value (7).
We should consider reserving the term “epidemiologist” for activity that encompasses the breadth of activities from survey design and data collection, in the field, through to analysis and publication and feedback. That these activities can more effectively be carried out with local knowledge and input, as Jephcott says, is hard to dispute. That the useful shorthand term for such an approach, “Field Epidemiology”, should go as well, I might, however, dispute.
1) Jephcott FL. Stuck in ‘the field’: why applied epidemiology needs to go home. BMJ Glob Health 2024;9:e015692. doi:10.1136/ bmjgh-2024-015692
2) Jephcott FL, Wood JLN, Cunningham AA, et al. Ineffective responses to unlikely outbreaks: hypothesis building in Newly‐ Emerging infectious disease outbreaks. Med Anthropol Q 2024;38:67–83.
3) Brown P. The jury is still out. BMJ 1995;311:1416
4) Brown P. Bovine spongiform encephalopahy and Creutzfeldt-Jakob disease. BMJ 1996;312:790
5) Cevik M, Rasmussen AL, Bogoch II, Kindrachuk J. Acute hepatitis of unknown origin in children. BMJ 2022;377:o1197
6) Salmon R, Palmer S. Recent hepatitis outbreak in children may have a foodborne toxin as its cause. BMJ 2022;377:o1518
7) Salmon R. Modelling the epidemic. London Review of Books. 2020;42:11. 4 June
We have read with interest the paper from Elias JJ et al. on the Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO).(1,2) The authors properly highlight two main objectives of the SoHO Regulation, namely, ensuring the safety (and quality) of SoHO for clinical use and strengthening the sufficiency in supply of what the Regulation defines as critical SoHO, an objective particularly relevant to the availability of plasma-derived therapeutic products. However, we would like to correct some inaccuracies and explain our insights on voluntary and unpaid donation (VUD).
First, the final text of the SoHO Regulation was adopted by the European Parliament on 24 April 2024 and the European Council is scheduled to formally adopt it later this month. Once adopted by the co-legislators and published in the Official Journal of the European Union (EU), the Regulation will enter into force and Member states (MS) will need to implement its provisions by 2027. Therefore, and contrary to what stated by the authors, the adopted text is no longer open to debate or amendments.
Second, the principle of VUD is not newly established by the Regulation, but already reflected in Directive 2002/98/EC on blood and blood components (3) and Directive 2004/23/EC on tissues and cells,(4) in alignment with the EU Charter of Fundamental Rights. The Charter enshrines the fundamental principle of human dignity and,...
We have read with interest the paper from Elias JJ et al. on the Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO).(1,2) The authors properly highlight two main objectives of the SoHO Regulation, namely, ensuring the safety (and quality) of SoHO for clinical use and strengthening the sufficiency in supply of what the Regulation defines as critical SoHO, an objective particularly relevant to the availability of plasma-derived therapeutic products. However, we would like to correct some inaccuracies and explain our insights on voluntary and unpaid donation (VUD).
First, the final text of the SoHO Regulation was adopted by the European Parliament on 24 April 2024 and the European Council is scheduled to formally adopt it later this month. Once adopted by the co-legislators and published in the Official Journal of the European Union (EU), the Regulation will enter into force and Member states (MS) will need to implement its provisions by 2027. Therefore, and contrary to what stated by the authors, the adopted text is no longer open to debate or amendments.
Second, the principle of VUD is not newly established by the Regulation, but already reflected in Directive 2002/98/EC on blood and blood components (3) and Directive 2004/23/EC on tissues and cells,(4) in alignment with the EU Charter of Fundamental Rights. The Charter enshrines the fundamental principle of human dignity and, in the fields of medicine and biology, the right to the integrity of the person, establishing the prohibition on making the human body and its parts, as such, a source of financial gain. We concur with the authors that the testing and processing methods currently available can guarantee high levels of safety of the donated SoHO regardless of donor payments. However, both the quality of the SoHO and the donor´s safety can be compromised in cases where the frequency of donation is too high. We also consider that the ethical implications of paying SoHO donors must be comprehensively addressed.(5-7) Remunerated SOHO donation inevitably leads to the most vulnerable becoming, to a great extent, the source of SoHO for those in need and has the potential to even stigmatize donation. SoHO donation must be embraced by the community as a gesture of solidarity and social responsibility, and the burden of donating SoHO should not fall primarily on economically disadvantaged groups.
Third, the Regulation provides the possibility for MS to allow donor compensation, defined as making good of any losses (preferably based on quantifiable criteria) or the reimbursement of expenses associated with SoHO donation. If MS decide to establish a compensation scheme, this should aim at financial neutrality. Thus, the Regulation supports the removal of financial barriers for those who wish to donate, but prohibits financial incentives that would distort the willingness of the population to contribute to the wellbeing of others by donating SoHO. This approach is based on the recommendations of the Council of Europe Committee on Bioethics published in 2018, following wide consultation.(5) We also wish to draw attention on a misinterpretation of Table 1. What the authors describe as payments for plasma donation are considered donor compensation schemes, consistent with the above-mentioned European Directives – though we acknowledge this misinterpretation highlights the thin line that can exist between remuneration and compensation. Finally, the authors seem to over-simplify the link between payments and supply, without addressing that certain countries may have an adequate supply of plasma for fractionation, but continue to experience shortages of plasma-derived medicinal products in their countries due to other, commercial, factors.
We recognize that the EU has heavily relied on the import of plasma from countries where remunerated donation is allowed. However, we are firmly convinced that the new SoHO Regulation will drive progress towards sufficiency in the supply of critical SoHO through measures aimed at strengthening the public system, without the need for violating the principle of VUD that has been strongly promoted by the European community. Achieving this level of sufficiency will help the global availability of SoHO and minimize shortages such as those experienced during the COVID-19 pandemic, mainly due to a drop in paid donations.
To gain a better understanding of the supply of plasma-derived medicinal products in Europe we strongly recommend consulting the valuable findings and recommendations of the SUPPLY Project, (8) in which European experts have analyzed the current situation in depth and propose measures to strengthen voluntary non-remunerated plasma collection in the EU.
REFERENCES
1. Elias JJ, Lacetera N, Macis M, Ockenfels A, Roth AE. Quality and safety for substances of human origins: scientific evidence and the new EU regulations. BMJ Glob Health. 2024 Apr 21;9(4):e015122. doi: 10.1136/bmjgh-2024-015122.
2. Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC. Available at: https://www.europarl.europa.eu/doceo/document/A-9-2023-0250-AM-244-244_E...
3. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32002L0098. Accessed: May 2024.
4. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:004.... Accessed: May 2024.
5. Guide for the implementation of the principle of financial gain. Available at: https://www.coe.int › bioethics. Accessed: May 2024.
6. Principles on the donation and management of blood, blood components and other medical products of human origin. Report of the WHO Secretariat. Available at: https://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_19-en.pdf . Accessed: May 2024.
7. Risk of commodification of substances of human origin a position statement of the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO). Available at: https://www.edqm.eu/documents/52006/0/OTC-CD-P-TO-Position-statement-Ris.... Accessed: May 2024.
8. Supply Project: Strengthening voluntary non-remunerated plasma collection capacity in Europe Available at: https://supply-project.eu/.Accessed: May 2024
Over the past two years, around 100 Countries worldwide have reported outbreaks of highly pathogenic avian influenza (HPAI) A(H5N1) viral disease. Alongside the recent detection of such pathogen in USA cattle, the finding of the viral agent in bovine raw milk samples, coupled with the identification of viral gene fragments in pasteurized cattle milk (which does not aiutonatically imply, however, the virus is still alive), are of additional concern. The ongoing viral spread and host range expansion to several phylogenetically distant species are also worrysome. Indeed, recently affected animals include domestic as well as wild avian (1) and mammalian species, both terrestrial and aquatic, such as cats, dogs, cattle, sheep, goats, black bears, red foxes, bobcats, badgers, seals, sea lions, harbor porpoises, bottlenose dolphins (2-5), and even the highly endangered polar bear (Ursus maritimus).
Within this rapidly evolving scenario, the prominent neurotropism and neuropathogenicity exhibited by A(H5N1) influenza virus in several bird and mammalian hosts (1-5) represent a further issue of concern.
Following the lessons learned from the COVID-19 pandemic, the more a virus circulates among animals, the more it can develop genetic mutations accelerating its progressive adaptation and spillover into new species.
How worried should we then be?
Over the past twenty years, approximately 900 human cases of HPAI A(H5N1) viral disease have been reported - includi...
Over the past two years, around 100 Countries worldwide have reported outbreaks of highly pathogenic avian influenza (HPAI) A(H5N1) viral disease. Alongside the recent detection of such pathogen in USA cattle, the finding of the viral agent in bovine raw milk samples, coupled with the identification of viral gene fragments in pasteurized cattle milk (which does not aiutonatically imply, however, the virus is still alive), are of additional concern. The ongoing viral spread and host range expansion to several phylogenetically distant species are also worrysome. Indeed, recently affected animals include domestic as well as wild avian (1) and mammalian species, both terrestrial and aquatic, such as cats, dogs, cattle, sheep, goats, black bears, red foxes, bobcats, badgers, seals, sea lions, harbor porpoises, bottlenose dolphins (2-5), and even the highly endangered polar bear (Ursus maritimus).
Within this rapidly evolving scenario, the prominent neurotropism and neuropathogenicity exhibited by A(H5N1) influenza virus in several bird and mammalian hosts (1-5) represent a further issue of concern.
Following the lessons learned from the COVID-19 pandemic, the more a virus circulates among animals, the more it can develop genetic mutations accelerating its progressive adaptation and spillover into new species.
How worried should we then be?
Over the past twenty years, approximately 900 human cases of HPAI A(H5N1) viral disease have been reported - including a recent one in Texas, likely acquired from an infected cow -, half of which were characterized by a lethal outcome. Luckily enough, however, no cases of human-to-human transmission have been hitherto documented.
Given the high propensity of influenza viruses to undergo genetic mutations, coupled with the fact that 70% of emerging infectious diseases are known to originate from an animal source, the possibility the A(H5N1) virus will become easily transmissible between people appears to be highly plausible, if not even likely.
Based upon the above, a multidisciplinary effort and a close collaboration between human and veterinary medicine are urgently needed in order to properly counteract this worrysome situation, within a sound One Health perspective's framework.
2) Puryear, W., et al. (2023). Highly Pathogenic Avian Influenza A(H5N1) Virus Outbreak in New England Seals, United States. Emerg. Infect. Dis. 29:786-791. doi: 10.3201/eid2904.221538.
3) Gamarra-Toledo, V., et al. (2023). Mass Mortality of Sea Lions Caused by Highly Pathogenic Avian Influenza A(H5N1) Virus. Emerg. Infect. Dis. 29:2553-2556. doi: 10.3201/eid2912.230192.
4) Thorsson, E., et al. (2023). Highly Pathogenic Avian Influenza A(H5N1) Virus in a Harbor Porpoise, Sweden. Emerg. Infect. Dis. 29:852-855. doi: 10.3201/eid2904.221426.
5) Murawski, A., et al. (2024). Highly pathogenic avian influenza A(H5N1) virus in a common bottlenose dolphin (Tursiops truncatus) in Florida. Commun. Biol. 7:476. doi: 10.1038/s42003-024-06.
This systematic review and individual patient data meta-analysis aimed to evaluate the safety and efficacy of primaquine in patients with Plasmodium vivax malaria from South Asia. The study's strengths include its comprehensive search strategy, thorough data extraction, and robust statistical analysis. However, several limitations and concerns arise from the study's methodology and results.
Firstly, the study's generalizability is limited by its focus on South Asia, which may not be representative of other regions where P. vivax malaria is endemic. Additionally, the study only included patients with uncomplicated P. vivax malaria, which may not reflect the more severe cases often seen in clinical practice.
Secondly, the study's inclusion criteria were quite restrictive, leading to the exclusion of 14 out of 32 identified studies due to lack of primaquine arm or incomplete data. This raises concerns about selection bias and the potential for missing important data.
Thirdly, the study's definition of "low" and "high" total dose primaquine regimens seems arbitrary and may not be universally accepted. The categorization of daily doses into "low", "intermediate", and "high" also lacks clear justification.
Fourthly, the study's haematological safety analysis was restricted to patients with ≥30% G6PD activity, which may not reflect the real-world scenario where patients wit...
This systematic review and individual patient data meta-analysis aimed to evaluate the safety and efficacy of primaquine in patients with Plasmodium vivax malaria from South Asia. The study's strengths include its comprehensive search strategy, thorough data extraction, and robust statistical analysis. However, several limitations and concerns arise from the study's methodology and results.
Firstly, the study's generalizability is limited by its focus on South Asia, which may not be representative of other regions where P. vivax malaria is endemic. Additionally, the study only included patients with uncomplicated P. vivax malaria, which may not reflect the more severe cases often seen in clinical practice.
Secondly, the study's inclusion criteria were quite restrictive, leading to the exclusion of 14 out of 32 identified studies due to lack of primaquine arm or incomplete data. This raises concerns about selection bias and the potential for missing important data.
Thirdly, the study's definition of "low" and "high" total dose primaquine regimens seems arbitrary and may not be universally accepted. The categorization of daily doses into "low", "intermediate", and "high" also lacks clear justification.
Fourthly, the study's haematological safety analysis was restricted to patients with ≥30% G6PD activity, which may not reflect the real-world scenario where patients with lower G6PD activity may still receive primaquine.
Fifthly, the study's tolerability analysis was severely limited by the lack of available data on adverse events such as vomiting, anorexia, diarrhoea, nausea, and abdominal pain following primaquine administration.
Sixthly, the reproduciblity of your study is very limited as the data and code behind the findings are not available publicly.
Lastly, the study's conclusions seem overly optimistic given the limited sample size and follow-up period. The authors' claim that high-dose primaquine is associated with zero recurrences at day 180 should be interpreted with caution, especially considering that only 96 patients received high-dose primaquine and most of them were followed up for less than 60 days.
In conclusion, while this study provides some insights into the safety and efficacy of primaquine in patients with P. vivax malaria from South Asia, its limitations and methodological concerns temper its findings. Future studies should aim to address these limitations and provide more comprehensive and generalizable results.
I noticed in Figure 2 of the article, “Comparison of WHO versus national COVID-19 therapeutic guidelines across the world: not exactly a perfect match”, that Taiwan was shown among “countries with no response or no access to their guidelines”. As the main coordinator of Taiwan’s COVID-19 Therapeutic Guideline Expert Committee, I am eager to share with your readers how we developed and revised our national guideline (NG) during January 2020 to December 2023, with the latest version being version 25 (1). Our committee was composed of experts from different fields, including clinicians (infection specialists, pulmonologists, intensivists), infection control specialists, laboratory experts, etc. We diligently reviewed the latest evidence on COVID-19 therapeutics, and revised the guideline timely.
For example, in version 2 of our NG, published on 2 February 2020, we recommended that lopinavir/ritonavir may be considered for patients with severe pneumonia or acute respiratory distress syndrome based on in vitro study results of other coronaviruses, which was the best evidence available at the beginning of the COVID-19 pandemic. The recommendation was retracted in version 5, released on 26 March 2020, soon after results of a clinical trial published on 18 March 2020 showing this was ineffective. Hydroxychloroquine was also once recommended by our NG and later removed after solid evidence against using this drug for COVID-19 treatment became available (...
I noticed in Figure 2 of the article, “Comparison of WHO versus national COVID-19 therapeutic guidelines across the world: not exactly a perfect match”, that Taiwan was shown among “countries with no response or no access to their guidelines”. As the main coordinator of Taiwan’s COVID-19 Therapeutic Guideline Expert Committee, I am eager to share with your readers how we developed and revised our national guideline (NG) during January 2020 to December 2023, with the latest version being version 25 (1). Our committee was composed of experts from different fields, including clinicians (infection specialists, pulmonologists, intensivists), infection control specialists, laboratory experts, etc. We diligently reviewed the latest evidence on COVID-19 therapeutics, and revised the guideline timely.
For example, in version 2 of our NG, published on 2 February 2020, we recommended that lopinavir/ritonavir may be considered for patients with severe pneumonia or acute respiratory distress syndrome based on in vitro study results of other coronaviruses, which was the best evidence available at the beginning of the COVID-19 pandemic. The recommendation was retracted in version 5, released on 26 March 2020, soon after results of a clinical trial published on 18 March 2020 showing this was ineffective. Hydroxychloroquine was also once recommended by our NG and later removed after solid evidence against using this drug for COVID-19 treatment became available (2). Dexamethasone has been recommended since version 8, released on 17 August 2020, after the result of SOLIDARITY trial became available (3).
We began listing evidence of all therapeutics in an appendix table since version 5. By the latest version available on 5 December 2023, the table had been updated 12 times, and included evidence on 25 different therapeutics and 133 references. Since version 11, released on 9 June 2021, we graded our recommendations by level of evidence, classifying therapeutics into “recommended” and “may be considered” for use. A table giving recommendations according to disease severity was also added in that version. Following each revision, major change to NG would be announced in our press conference, and doctors were also notified through “e-Letter to Doctors”.
In the latest version of our NG, published on 5 December 2023, we recommend 8 out of 10 drugs recommended by WHO, including dexamethasone, tocilizumab, baricitinib, tofacitinib, remdesivir, nirmatrelvir/ritonavir, molnupiravir and tixagevimab/cilgavimab according to disease severity. None of the drugs or monoclonal antibodies that WHO had advised against their use were recommended in our NG. Compared with version 19 version released on 26 May 2022, only Casirivimab-imdevimab was removed and other recommendations had not changed. Using the metric calculation proposed by Cokljat et al, our NG scored 15 for severe/critical guidelines, and 14 for non-severe guidelines, far higher than the average of countries in the Western Pacific Region (5.8 for severe disease and 7.25 for non-severe disease).
During a pandemic, it is the public health authorities’ mandate to ensure patients are given the best treatment available. With the help from experts in different fields, Taiwan developed our own NG that aligned with WHO recommendations, providing concise and evidence-based recommendation for treating COVID-19 patients. Our NG also served as an information hub for clinicians to be updated with the latest relevant scientific literature. We believe that reviewing the latest evidence, timely revision of guidelines, and effective communication with clinicians were all key to successful COVID-19 control.
Sincerely,
Tsung-Pei Tsou, MD
Medical Officer
Taiwan Centers for Disease Control
1. SARS-CoV-2 clinical management guideline, 25th edition (in Chinese). https://www.cdc.gov.tw/File/Get/Pv_cnYQ7CfYBFXg_J3_Ffg
2. A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med 2020;382:1787-1799
3. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med 2021;384:693-704
A commentary paper in your journal by Besancon et al. [1] suggests that industry is opposing the Nutri-Score system and hence preferentially publishes papers that support criticism on that front-of-pack label. It is concluded by Besancon et al. [1] that ‘a study is 21 times more likely to show unfavourable results if the authors have a conflict of interest or the study is funded by the food industry’. The figure of ’21 times’ is suggestive because there are too many unscientific assumptions behind this figure. One assumption is that a study is of poor quality or a biased study if it shows unfavourable results to Nutri-Score and/or if there is a mention of a Conflict of Interest, i.e. sponsored by industry. A second assumption is that studies that are carried out by the developers of Nutri-Score are by definition of good quality and unbiased. Moreover, we found out that Besancon et al. [1] did not conduct a comprehensive search of the literature: they just used the literature list on the website of the developers of Nutri-Score (https://nutriscore.blog/author/logonutriscore/ d.d. August 2023). This list was far from complete, i.e. it did not comprise all peer-reviewed papers about Nutri-Score, especially not the papers that are unfavourable for Nutri-Score. Finally, the analysis by Besancon et al. was limited to the outcome of the studies, without considering the detailed content of the pape...
A commentary paper in your journal by Besancon et al. [1] suggests that industry is opposing the Nutri-Score system and hence preferentially publishes papers that support criticism on that front-of-pack label. It is concluded by Besancon et al. [1] that ‘a study is 21 times more likely to show unfavourable results if the authors have a conflict of interest or the study is funded by the food industry’. The figure of ’21 times’ is suggestive because there are too many unscientific assumptions behind this figure. One assumption is that a study is of poor quality or a biased study if it shows unfavourable results to Nutri-Score and/or if there is a mention of a Conflict of Interest, i.e. sponsored by industry. A second assumption is that studies that are carried out by the developers of Nutri-Score are by definition of good quality and unbiased. Moreover, we found out that Besancon et al. [1] did not conduct a comprehensive search of the literature: they just used the literature list on the website of the developers of Nutri-Score (https://nutriscore.blog/author/logonutriscore/ d.d. August 2023). This list was far from complete, i.e. it did not comprise all peer-reviewed papers about Nutri-Score, especially not the papers that are unfavourable for Nutri-Score. Finally, the analysis by Besancon et al. was limited to the outcome of the studies, without considering the detailed content of the papers or their relevance for the validation of Nutri-Score.
In order to present a complete overview of published literature, recently, we published another study on the validation and efficacy of Nutri-Score and found suggestion for a large publication bias (Peters & Verhagen 2024 [2]. in which we report that the large majority of studies that support Nutri-Score are carried out by the developers of Nutri-Score. In contrast, the majority of studies that are carried out independently from the developers of Nutri-Score showed unfavourable results. For our study we have extended the table of Besancon et al. with the missing literature and added columns to show the relevance of the studies for the validation of the effectiveness of Nutri-Score and added remarks when we were not in line with the conclusions of Besancon et al. with respect to whether studies were favourable or unfavourable to Nutri-Score. All details can be found in the supplementary material of our study [2].
Our paper [2] has received a rebuttal by the developers of Nutri-Score [3] challenging our conclusions. Interestingly, this rebuttal to our recent paper by the developers of Nutri-Score, perhaps ironically but essentially, confirms our analysis: there is a publication bias versus affiliation.
Whereas in our comprehensive analysis [2], the publications by the developers of Nutri-Score are nearly all favourable towards Nutri-Score (52 of 56 papers; 93%), in the rebuttal by Touvier et al. [3] it is stated that even 100% of their papers have a favourable outcome. When only considering papers that were published by authors that are not at all affiliated with the developers of Nutri-Score, a similar pattern is visible: we [2] conclude that only 19 out of 49 papers (39%) are in favour, and the developers of Nutri-Score [3] fully confirm this outcome: 20 out of 44 (45%) are in favour of Nutri-Score.
We have published a reply [4] to the rebuttal by team Nutri-Score [3] and concluded that when taking together the rebuttal by Touvier et al. [3] and our study [2], the final conclusion cannot be denied by either party: There is a clear suggestion of publication bias behind the studies about Nutri-Score, coming from either direction.
It is our opinion that the evaluation of the effectiveness of Nutri-Score should be carried out by an independent food authority. We suggest that the European Food Safety Authority (EFSA) should carry out this important job, because we question the current situation that the scientific development, the evaluation of the scientific development and the updating of the errors in the algorithm are all being conducted by the developers of Nutri-Score.
References:
1. Besancon, S.; Beran, D.; Batal, M. A study is 21 times more likely to find unfavourable results about the nutrition label Nutri-Score if the authors declare a conflict of interest or the study is funded by the food industry. BMJ Glob Health 2023, 8, doi:10.1136/bmjgh-2023-011720.
2. Peters, S.; Verhagen, H. Publication bias and Nutri-Score: A complete literature review of the substantiation of the effectiveness of the front-of-pack logo Nutri-Score. PharmaNutrition 2024, 27, 100380, doi:10.1016/j.phanu.2024.100380.
3. Touvier, M.; P., G.; Julia, C.; Deschasaux-Tanguy, M.; Srour, B.; Kesse-Guyot, E.; Andreeva, E.; Hercberg, C. Rebuttal to the (pre-proof) paper published by S. Peters and H. Verhagen. PharmaNutrition 2024, 24, 100386.
4. Peters, S.; Verhagen, H. Coming from opposite parts of the spectrum of interpreting studies about Nutri-Score: Suggestion of publication bias cannot be denied. PharmaNutrition 2024, 28, 100387.
Congratulations on this well-designed study. I carefully read your study with great interest. I decided to write a commentary on your study as it discusses a field I am most passionate about.
- Introduction:
The introduction provides a comprehensive background on the use of herbal medicine (HM) during pregnancy, the potential risks, and the importance of effective patient-physician communication. The rationale for conducting this systematic review is well-justified.
- Methods:
The search strategy is well-described and comprehensive, covering multiple relevant databases and using appropriate keywords and search terms.
The eligibility criteria for study inclusion are clearly stated and reasonable.
The process of study selection, data extraction, and risk of bias assessment is described in detail and appears to be rigorous.
The methods for data synthesis and statistical analysis, including the use of subgroup analyses and correlation analyses, are appropriate and well-explained.
- Results:
The results are presented systematically and clearly, with the use of tables, figures, and forest plots to effectively visualize the findings.
The findings related to the prevalence of HM use during pregnancy, the rates of disclosure to healthcare providers, and the factors associated with disclosure are insightful and well-supported by the data.
The subgroup analyses based on geographical regio...
Congratulations on this well-designed study. I carefully read your study with great interest. I decided to write a commentary on your study as it discusses a field I am most passionate about.
- Introduction:
The introduction provides a comprehensive background on the use of herbal medicine (HM) during pregnancy, the potential risks, and the importance of effective patient-physician communication. The rationale for conducting this systematic review is well-justified.
- Methods:
The search strategy is well-described and comprehensive, covering multiple relevant databases and using appropriate keywords and search terms.
The eligibility criteria for study inclusion are clearly stated and reasonable.
The process of study selection, data extraction, and risk of bias assessment is described in detail and appears to be rigorous.
The methods for data synthesis and statistical analysis, including the use of subgroup analyses and correlation analyses, are appropriate and well-explained.
- Results:
The results are presented systematically and clearly, with the use of tables, figures, and forest plots to effectively visualize the findings.
The findings related to the prevalence of HM use during pregnancy, the rates of disclosure to healthcare providers, and the factors associated with disclosure are insightful and well-supported by the data.
The subgroup analyses based on geographical region, study year, and various maternal and child health (MCH) indicators provide valuable insights into the variations and potential determinants of HM use and disclosure.
The additional findings related to patient-physician communication on HM use, such as the lack of inquiry from physicians and the reasons for non-disclosure, are informative and contribute to a better understanding of the problem.
- Discussion:
The discussion section provides a comprehensive interpretation of the findings, drawing upon relevant literature and theories to support the interpretations.
The authors effectively highlight the potential consequences of inappropriate HM use and the importance of open patient-physician communication in preventing adverse MCH outcomes.
The discussion of the study's limitations is appropriate and acknowledges the potential impact of factors such as language restrictions, non-random sampling, and variations in study characteristics.
- Conclusion:
The conclusion summarizes the key findings and provides practical recommendations for promoting effective patient-physician communication on HM use during antenatal care, such as training healthcare professionals, implementing community outreach programs, and integrating inquiries about HM use into routine antenatal care.
Overall, this systematic review and meta-analysis is well-designed, well-executed, and provides valuable insights into the use of HM during pregnancy and the importance of patient-physician communication. The authors have addressed the research questions comprehensively and have employed rigorous methods for data synthesis and analysis. The study findings have important implications for healthcare practice and policy and can inform efforts to promote safe and appropriate HM use during pregnancy.
Suggestions for improvement:
- The authors could consider discussing the potential impact of cultural and socioeconomic factors on HM use and disclosure, as these factors may vary across different geographical regions and influence patient-physician communication.
- Additional subgroup analyses based on specific types of HM or indications for use could provide further insights into the patterns of HM use and disclosure, although the authors acknowledge the limitations in data availability.
- The authors could explore the potential for publication bias in more detail, as this may influence the overall prevalence estimates.
Overall, this is a well-conducted systematic review and meta-analysis that contributes valuable knowledge to the field of maternal and child health.
Dear editor,
Both the commentary from Elias et al, “Quality and safety for substances of human origins: scientific evidence and the new EU regulations”, and the response to that commentary from Domínguez-Gil et al, recently published in BMJ Global Health (1) caught our attention. The response from Domínguez-Gil et al eloquently explains the recommitment to the principle of voluntary and unpaid donation in the new SoHO Regulation(2) and comprehensively addresses several statements in the commentary from Elias et al which required clarification. Some additional items in the commentary are addressed here.
The commentary states that “in Europe, countries allowing monetary compensation for donors are the only ones achieving self-sufficiency in plasma collection for the production of immunoglobulin.’ While four countries collect more plasma than they theoretically need to meet their patients’ current needs (Austria, Czechia, Germany, and Hungary) the finished plasma-derived medicines, including Immunoglobulins, are dispatched to those countries where the company markets these products, independently from the origin of the plasma.(3,4) Czechia is noteworthy because its blood and plasma collection systems generate the highest per capita collection globally,(5) including a high volume of plasma collected in public hospitals. Concurrently, immunoglobulin provision in this same country is below half of the average per capita usage for this product across the EU, and yet...
Show MoreI write to offer a critical evaluation of the thought-provoking article titled "Capitalogenic Disease: Social Determinants in Focus" by [Author's Name] in [Journal Name]. This article sheds light on the impact of capitalism on health outcomes and proposes the term "capitalogenic disease" as an analytical framework to examine the adverse effects of the capitalist system on public health. While the article presents compelling arguments, it is important to critically explore certain aspects to expand the discourse on this subject.
The author rightly emphasizes the significance of understanding the specific political and economic systems within the broader context of social determinants of health. By focusing on capitalism and its associated dynamics of capital accumulation, the article draws attention to the root causes of health disparities and highlights the prioritization of profits and growth over human well-being. This perspective offers valuable insights into the harmful influence of commercial determinants, patent regimens, poverty, and unequal access to healthcare.
Moreover, the article rightly identifies the impact of capitalism on marginalized communities, particularly in the global South. By relying on historical evidence and contemporary examples, such as the tobacco and food industries' unethical practices, the article underscores the importance of addressing structural factors and power imbalances to tackle health ineq...
Show MoreUnveiling Oversights and Underreporting: A Rebuttal of Sri Lanka's COVID-19 Response Analysis
Abstract
In response to an analysis of Sri Lanka's COVID-19 handling , this rebuttal delves into critical deficiencies in the data used and contextual factors influencing governmental decisions. It presents objective data showing Sri Lanka's poor performance in managing COVID-19 despite its healthcare infrastructure advantages. The initial success is attributed more to political motivations surrounding parliamentary elections rather than effective public health measures. Ethnoreligious stigmatisation exacerbated the crisis, impacting testing efforts and vaccination uptake, while economic mismanagement further worsened the situation, leading to the ousting of the Executive President in 2022. This rejoinder criticises the article for not explicitly recognising or downplaying these factors' significance. It concludes that while the study contributes to the lessons to be learned for the management of future pandemics in Sri Lanka, it overlooks crucial aspects, potentially skewing lessons for the future. Due to brevity of space, we are unable to publish our entire rejoinder, including the data table, which could be obtained from the corresponding author of this rejoinder.
Introduction
Acknowledging the exhaustive analysis by the authors regarding Sri Lanka's responses to and management of COVID-19, this rebuttal endeavours to shed li...
Show MorePrompted by a BMJ publications email to look at this recent editorial in BMJ Global Health, as someone with a lifelong career as a self styled “Field Epidemiologist”, my interest was instantly piqued by its title (1). It and the supporting Medical Anthropology Quarterly article(2) that it drew heavily upon did not disappoint. It’s a stimulating read that all of us in the field would do well to reflect on.
Even in a career carried out almost exclusively in the developed country setting of the UK, I encountered “organizational features of hypothesis building”, “structural bias”, that resulted in error. Initial reluctance to acknowledge the zoonotic potential of Bovine Spongiform Encephalopathy (BSE) was prompted in part by the success of the emerging science of molecular genetics in explaining clusters in other countries. In 1995, one acknowledged global expert published a BMJ education and debate piece, implying that a consequence of such suggestions of zoonotic spread, even in the face of emerging evidence, might be, “a class action suit for anxiety brought by the entire British population against its own government” (3) although he did have the grace subsequently to acknowledge his error (4). In the recent international outbreak of hepatitis of unknown cause, viral explanations have predominated (5), even though the epidemiological pattern is more suggestive of a toxin as a cause (6).
My colleagues and I might be characterised, I suppose, as "elite...
Show MoreDear Editor
We have read with interest the paper from Elias JJ et al. on the Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO).(1,2) The authors properly highlight two main objectives of the SoHO Regulation, namely, ensuring the safety (and quality) of SoHO for clinical use and strengthening the sufficiency in supply of what the Regulation defines as critical SoHO, an objective particularly relevant to the availability of plasma-derived therapeutic products. However, we would like to correct some inaccuracies and explain our insights on voluntary and unpaid donation (VUD).
First, the final text of the SoHO Regulation was adopted by the European Parliament on 24 April 2024 and the European Council is scheduled to formally adopt it later this month. Once adopted by the co-legislators and published in the Official Journal of the European Union (EU), the Regulation will enter into force and Member states (MS) will need to implement its provisions by 2027. Therefore, and contrary to what stated by the authors, the adopted text is no longer open to debate or amendments.
Second, the principle of VUD is not newly established by the Regulation, but already reflected in Directive 2002/98/EC on blood and blood components (3) and Directive 2004/23/EC on tissues and cells,(4) in alignment with the EU Charter of Fundamental Rights. The Charter enshrines the fundamental principle of human dignity and,...
Show MoreOver the past two years, around 100 Countries worldwide have reported outbreaks of highly pathogenic avian influenza (HPAI) A(H5N1) viral disease. Alongside the recent detection of such pathogen in USA cattle, the finding of the viral agent in bovine raw milk samples, coupled with the identification of viral gene fragments in pasteurized cattle milk (which does not aiutonatically imply, however, the virus is still alive), are of additional concern. The ongoing viral spread and host range expansion to several phylogenetically distant species are also worrysome. Indeed, recently affected animals include domestic as well as wild avian (1) and mammalian species, both terrestrial and aquatic, such as cats, dogs, cattle, sheep, goats, black bears, red foxes, bobcats, badgers, seals, sea lions, harbor porpoises, bottlenose dolphins (2-5), and even the highly endangered polar bear (Ursus maritimus).
Show MoreWithin this rapidly evolving scenario, the prominent neurotropism and neuropathogenicity exhibited by A(H5N1) influenza virus in several bird and mammalian hosts (1-5) represent a further issue of concern.
Following the lessons learned from the COVID-19 pandemic, the more a virus circulates among animals, the more it can develop genetic mutations accelerating its progressive adaptation and spillover into new species.
How worried should we then be?
Over the past twenty years, approximately 900 human cases of HPAI A(H5N1) viral disease have been reported - includi...
This systematic review and individual patient data meta-analysis aimed to evaluate the safety and efficacy of primaquine in patients with Plasmodium vivax malaria from South Asia. The study's strengths include its comprehensive search strategy, thorough data extraction, and robust statistical analysis. However, several limitations and concerns arise from the study's methodology and results.
Firstly, the study's generalizability is limited by its focus on South Asia, which may not be representative of other regions where P. vivax malaria is endemic. Additionally, the study only included patients with uncomplicated P. vivax malaria, which may not reflect the more severe cases often seen in clinical practice.
Secondly, the study's inclusion criteria were quite restrictive, leading to the exclusion of 14 out of 32 identified studies due to lack of primaquine arm or incomplete data. This raises concerns about selection bias and the potential for missing important data.
Thirdly, the study's definition of "low" and "high" total dose primaquine regimens seems arbitrary and may not be universally accepted. The categorization of daily doses into "low", "intermediate", and "high" also lacks clear justification.
Fourthly, the study's haematological safety analysis was restricted to patients with ≥30% G6PD activity, which may not reflect the real-world scenario where patients wit...
Show MoreDear Editor,
I noticed in Figure 2 of the article, “Comparison of WHO versus national COVID-19 therapeutic guidelines across the world: not exactly a perfect match”, that Taiwan was shown among “countries with no response or no access to their guidelines”. As the main coordinator of Taiwan’s COVID-19 Therapeutic Guideline Expert Committee, I am eager to share with your readers how we developed and revised our national guideline (NG) during January 2020 to December 2023, with the latest version being version 25 (1). Our committee was composed of experts from different fields, including clinicians (infection specialists, pulmonologists, intensivists), infection control specialists, laboratory experts, etc. We diligently reviewed the latest evidence on COVID-19 therapeutics, and revised the guideline timely.
For example, in version 2 of our NG, published on 2 February 2020, we recommended that lopinavir/ritonavir may be considered for patients with severe pneumonia or acute respiratory distress syndrome based on in vitro study results of other coronaviruses, which was the best evidence available at the beginning of the COVID-19 pandemic. The recommendation was retracted in version 5, released on 26 March 2020, soon after results of a clinical trial published on 18 March 2020 showing this was ineffective. Hydroxychloroquine was also once recommended by our NG and later removed after solid evidence against using this drug for COVID-19 treatment became available (...
Show MoreDear Editor,
A commentary paper in your journal by Besancon et al. [1] suggests that industry is opposing the Nutri-Score system and hence preferentially publishes papers that support criticism on that front-of-pack label. It is concluded by Besancon et al. [1] that ‘a study is 21 times more likely to show unfavourable results if the authors have a conflict of interest or the study is funded by the food industry’. The figure of ’21 times’ is suggestive because there are too many unscientific assumptions behind this figure. One assumption is that a study is of poor quality or a biased study if it shows unfavourable results to Nutri-Score and/or if there is a mention of a Conflict of Interest, i.e. sponsored by industry. A second assumption is that studies that are carried out by the developers of Nutri-Score are by definition of good quality and unbiased. Moreover, we found out that Besancon et al. [1] did not conduct a comprehensive search of the literature: they just used the literature list on the website of the developers of Nutri-Score (https://nutriscore.blog/author/logonutriscore/ d.d. August 2023). This list was far from complete, i.e. it did not comprise all peer-reviewed papers about Nutri-Score, especially not the papers that are unfavourable for Nutri-Score. Finally, the analysis by Besancon et al. was limited to the outcome of the studies, without considering the detailed content of the pape...
Show MoreDear esteemed authors,
Congratulations on this well-designed study. I carefully read your study with great interest. I decided to write a commentary on your study as it discusses a field I am most passionate about.
- Introduction:
Show MoreThe introduction provides a comprehensive background on the use of herbal medicine (HM) during pregnancy, the potential risks, and the importance of effective patient-physician communication. The rationale for conducting this systematic review is well-justified.
- Methods:
The search strategy is well-described and comprehensive, covering multiple relevant databases and using appropriate keywords and search terms.
The eligibility criteria for study inclusion are clearly stated and reasonable.
The process of study selection, data extraction, and risk of bias assessment is described in detail and appears to be rigorous.
The methods for data synthesis and statistical analysis, including the use of subgroup analyses and correlation analyses, are appropriate and well-explained.
- Results:
The results are presented systematically and clearly, with the use of tables, figures, and forest plots to effectively visualize the findings.
The findings related to the prevalence of HM use during pregnancy, the rates of disclosure to healthcare providers, and the factors associated with disclosure are insightful and well-supported by the data.
The subgroup analyses based on geographical regio...
Pages