06 de setembre 2020

A consensus over genome editing

 Heritable human genome editing

Key goal:

The International Commission on the Clinical Use of Human Germline Genome Editing,which was convened by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences, and the U.K.’s Royal Society and includes members from 10 countries, was tasked with addressing the scientific considerations that would be needed to inform broader societal decision-making. This task involves considering technical, scientific, medical, and regulatoryrequirements, as well as those societal and ethical issues that are inextricably linked to theserequirements, such as the significance of uncertainties related to outcomes, and potential benefits and harms to participants in clinical uses of HHGE.This report does not make judgments about whether any clinical uses of a safe andeffective HHGE methodology, if established by pre-clinical research, should at some point bepermitted. The report instead seeks to determine whether the safety and efficacy of genome editing methodologies and associated assisted reproductive technologies are or could be sufficiently well developed to permit responsible clinical use of HHGE; identifies initial potential applications of HHGE for which a responsible clinical translational pathway can currently be defined; and delineates the necessary elements of such a translational pathway. It also elaborates national and international mechanisms necessary for appropriate scientificgovernance of HHGE, while recognizing that additional governance mechanisms may be needed to address societal considerations that lie beyond the Commission’s charge.

A crucial report, a must read with 11 recommendations, I highlight only 2 below:

 Recommendation 10: In order to proceed with applications of heritable human genome editing (HHGE) that go beyond the translational pathway defined for initial classes of use of HHGE, an international body with appropriate standing and diverse expertise and experience should evaluate and make recommendations concerning any proposed new class of use. This international body should:

• clearly define each proposed new class of use and its limitations;

• enable and convene ongoing transparent discussions on the societal issues surrounding the new class of use;

• make recommendations concerning whether it could be appropriate to cross the threshold of permitting the new class of use; and

• provide a responsible translational pathway for the new class of use.

Recommendation 11: An international mechanism should be established by which concerns about research or conduct of heritable human genome editing that deviates from established guidelines or recommended standards can be received, transmitted to relevant national authorities, and publicly disclosed.

Unfortunately Catalan government was not among the 10 countries in the meeting. Is there anybody concerned on this issue? 


 

05 de setembre 2020

Vaccine allocation (2)

 An ethical framework for global vaccine allocation

Ezequiel Emanuel et al. article:

Fairly distributing a COVID-19 vaccine among countries is a problem of distributive justice. Although governments will be the initial recipients of vaccine, fair distribution across countries must reflect a moral concern for the ultimate recipients: individuals. Three values are particularly relevant: benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern.

Benefiting people and limiting harm is widely recognized as important across ethical theories. Realizing this value requires defining relevant benefits, measuring them, and assessing the relative urgency—the importance and time sensitivity—of countries’ needs. A successful vaccine produces direct benefits by protecting people against death and morbidity caused by infection. It also produces indirect benefits by reducing death and morbidity arising from health systems overstressed by the pandemic, and by reducing poverty and social hardship such as closed schools.

Prioritizing the disadvantaged is a fundamental value in ethics and global health (10, 11). Realizing this value requires that vaccine distribution reflect special concern for people who are disadvantaged. Fairly distributing a COVID-19 vaccine internationally therefore requires assessing different types of disadvantage. Are the worst-off countries those experiencing the greatest poverty? Those where people have the lowest life expectancies?

Equal moral concern requires treating similar individuals similarly and not discriminating on the basis of morally irrelevant differences, such as sex, race, and religion. Distributing different quantities of vaccine to different countries is not discriminatory if it effectively benefits people while prioritizing the disadvantaged.

And the allocation model: 

 The Fair Priority Model proceeds in three phases, preventing more urgent harms earlier (see the Table). Phase 1 aims at reducing premature deaths and other irreversible direct and indirect health impacts. Phase 2 continues to address enduring health harms but additionally aims at reducing serious economic and social deprivations such as the closure of nonessential businesses and schools. Restoring these activities will lower unemployment, reduce poverty, and improve health. Finally, phase 3 aims at reducing community transmission, which in turn reduces spread among countries and permits the restoration of prepandemic freedoms and economic and social activities.

 

04 de setembre 2020

Vaccine allocation

 Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine


Guiding Principles from Allocation Frameworks Developed for the COVID-19 Pandemic:

• Ensure that allocation maximizes benefit to patients, mitigates inequities and disparities, and adheres to ethical principles.

• Promote the common good through fairness, transparency, accountability, and trustworthiness.

• Save the greatest number of lives possible—while respecting rights and fairness—to

maximize benefit to the community as a whole.

• Use the best available evidence to assess benefit to communities and address uncertainty.

• Allocate scarce resources responsibly to reduce risk while providing benefit.

• Provide clear and transparent criteria for prioritization strategies.

• Ensure that allocation policies are flexible, responsive to the concerns of the affected

population, and proportionate to the epidemiological situation and the vaccine supply relative to need.

How to proceed in practical terms? Who knows...



 Hockney

03 de setembre 2020

Vaccine nationalism

 The Optimal Allocation of Covid-19 Vaccines

Covid-19 vaccine prioritization is key if the initial supply of the vaccine is limited. A consensus is emerging to first prioritize populations facing a high risk of severe illness in high-exposure occupations. The challenge is assigning priorities next among high-risk populations in low-exposure occupations and those that are young and healthy but work in high-exposure occupations. We estimate occupation-based infection risks and use age-based infection fatality rates in a model to assign priorities over populations with different occupations and ages. Among others, we find that 50-year-old food-processing workers and 60-year-old financial advisors are equally prioritized. Our model suggests a vaccine distribution that emphasizes age-based mortality risk more than occupation-based exposure risk.

Today we can confirm that the probability of such proposal is low. After reading FT, WHO framework has suffered a setback.



Banksy