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Global Call to Boost Diversity of Genomic Medicine

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The COVID-19 pandemic provides another painful example of the healthcare disparities experienced among ethnic populations. These disparities are not unique to COVID-19, but are the latest consequence of longstanding gaps in population understanding, inclusion in research and access to targeted care.

As the industry moves towards more precise disease screenings, diagnostics and treatments thanks to genomic research, these disparities will grow. Analysis found 78% of people in genome-wide association studies are of European descent. Additionally, researchers from the Broad Institute of MIT and Harvard and Massachusetts General Hospital found data from the UK Biobank had a 4.5 times higher prediction accuracy for people of European ancestry than those of African ancestry, and two times higher accuracy than those of East Asian ancestry.

“The lack of diversity in research studies is leading to blind spots,” said Elissa Prichep, Project Lead, World Economic Forum. “Translated to the clinic, this means non-white minority populations may receive less accurate preventative screenings, less reliable diagnostics, less targeted treatments.”

To support policy-makers, scientists, research participants and others in developing approaches that will lead to more inclusive genomic research, a new World Economic Forum policy framework can help unlock data and safeguard against the harms that can transpire when genomic data is used unchecked.

This work was developed in collaboration with more than 30 global leaders and written from a “future of healthcare” perspective to address the unique and challenging issues raised with the use of genomic data, beyond those that arise with use of physical samples. The focus on emerging economies is intended to ensure consideration of differing perspectives and needs informed by these countries’ diverse historical, societal and cultural contexts.

“A deeper understanding of the genetic diversity across populations will transform healthcare research, promote tailored healthcare delivery and reduce the disease burden across the African continent,” said Thomas Kariuki, Director of Programmes, The African Academy of Sciences. “To this end, the World Economic Forum’s white paper elevates critical policy and ethical considerations in protecting individuals and ensuring equitability in international collaborations.”

“Advances in genomics research are accelerating the medical breakthroughs that will improve health for all people,” said Francis Collins, Director of the National Institutes for Health. “However, it is important to remember that the data driving these advances begins with human volunteers who consent to providing it for research. This whitepaper encourages greater consideration of the perspective of research participants, and provides tools to help policy makers and scientific leaders navigate the important ethical and societal issues associated with genomic research.”

The white paper includes a scalable policy framework in categories of consent, data privacy, data access and benefit sharing, which offers 21 policy principles including autonomy, accountability, dignity and cooperation. The study highlights six ethical tensions – such as the tension of balancing individual privacy and societal benefit – to show the competing ethical priorities surrounding genomic data and underpin the policy framework. To assist in thorough, diligent and nuanced discussion, the documents also provide a set of questions to guide ethical policy development.

“There is vast potential in the collection and use of genomic data to realize the promise of precision medicine, but we must develop forward-looking policies around genomic data before significant amounts of this data is generated,” said Catalina Lopez-Correa, Chief Operating Officer, Ruta N Medellin. “Low- and middle- income countries and emerging economies now have a unique opportunity to be ahead of the game by proactively developing policies around genomic data, and the World Economic Forum’s white paper will be extremely helpful in guiding policy development through providing frameworks and guidance around genomic data.”

The white paper should be used to drive multistakeholder discussion and decision-making, with the intent that policy-makers, business leaders, researchers and others leverage and adapt this work for use in a local context. To support this, the white paper is released with a companion ethical tensions guidance document and genomic data policy resource list.

Insufficient genomic data policies expose countries and communities to the risk that certain actors will extract genetic and biologic information from their population and use it for their own benefit. These risks have previously been realized – harming the Havasupai in the southwestern United States, the San in Southern Africa and others – and will occur again without undertaking a multistakeholder approach towards developing policies and regulations in a local context and with the inclusion of local populations.

The World Economic Forum’s Platform on Shaping the Future of Health and Healthcare aims to ensure that the 9.7 billion people on earth by 2050 have equal rights to access the highest standards of health and healthcare. In accordance with this mission, we are grateful to contribute a Genomic Data Policy Framework and Ethical Tensions white paper, as part of a set of tools.

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Delta variant, a warning the COVID-19 virus is getting ‘fitter and faster’

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Cases and deaths resulting from COVID-19 continue to climb worldwide, mostly fuelled by the highly transmissible Delta variant, which has spread to 132 countries, said the head of the World Health Organization (WHO) on Friday.

Almost 4 million cases worldwide were reported last week to WHO and the agency expects the total number of cases to pass 200 million, in the next two weeks.

“And we know this is an underestimate”, underscored Director-General Tedros Adhanom Gebreyesus during his regular COVID-19 briefing.

Infections have increased in every region of the world, with some even reaching 80 per cent more in the past month. In Africa, deaths have increased by 80 per cent over the same period, the official warned.

Overwhelmed

Tedros blamed the rise of cases on increased social mixing and mobility, the inconsistent use of public health and social measures, and inequitable vaccine use. He said “hard-won gains” are in jeopardy or being lost, and health systems in many countries are increasingly overwhelmed.

“WHO has warned that the COVID-19 virus has been changing since it was first reported, and it continues to change. So far, four variants of concern have emerged, and there will be more as long as the virus continues to spread”, he underscored.

A higher viral load

Lead WHO epidemiologist and COVID-19 technical lead, Dr. Maria Van Kerkhove, explained that the Delta variant has certain mutations that allow the virus to adhere to human cells more easily and that experts are also seeing a higher viral load in individuals infected.

She called Delta “dangerous and the most transmissible SARS-CoV-2 virus to date”. 

“There are some laboratory studies that suggest that there’s increase replication in some of the modelled human airway systems”, she added.

In terms of severity, Dr. Van Kerkhove highlighted that there has been an increase in hospitalizations in certain countries affected by the variant, “but we haven’t yet seen an increase in mortality”.

The WHO expert reminded that although there is some data that suggest that people vaccinated can get infected and transmit the variant, the likelihood is much reduced after the second dose has been administered and reached full effectiveness.

She also clarified that Delta is not specifically targeting children as some reports have suggested, but warned that as long as the variants are circulating, they will infect anybody that is not taking proper precautions.

Continuing to evolve

“It’s in the virus’s interests to evolve, viruses are not alive they don’t have a brain to think through this, but they become more fit the more they circulate, so the virus will likely become even more transmissible because this is what viruses do, they evolve they change overtime”, Dr. Van Kerkhove warned, echoing Tedros’ remarks.

We have to do what we can to drive it down”, she added, reminding that public health and social measures do work against the Delta variant, and that the vaccines do prevent disease and death.

Dr. Michael Ryan, Executive Director of WHO Health Emergencies, said that even with the virus getting “faster and fitter” the gameplan does not change, but It needs to be implemented more efficiently.

“Delta is a warning that this virus is evolving, but it is also a call to action before more dangerous variants emerge”, he said.

Shots for Africa

Last month, the WHO chief announced the setting up of a technology transfer hub for mRNA vaccines In South Africa as part of WHO’s efforts to scale up production of vaccines and their distribution in Africa.

“Today we have taken another step forward, with a letter of intent that sets out the terms of collaboration signed by the partners in the hub: WHO; the Medicines Patent Pool; Afrigen Biologics; the Biologicals and Vaccines Institute of Southern Africa; the South African Medical Research Council and the Africa Centres for Disease Control and Prevention”, Tedros explained.

He added that WHO’s goal remains to aid every country in vaccinating at least 10% of its population by the end of September, at least 40% by the end of this year, and 70% by the middle of next year.

“We are a long way off achieving those targets. So far, just over half of countries have fully vaccinated 10% of their population, less than a quarter of countries have vaccinated 40%, and only 3 countries have vaccinated 70%”, Tedros warned.

The WHO head reminded that the global distribution of vaccines remains unjust, despite expert warnings and appeals, and said that all regions remain at risk, “none more so, than Africa”.

“On current trends, nearly 70% of African countries will not reach the 10% vaccination target by the end of September”, he cautioned.

New tool to fight Delta

Tedros also announced that on response to the Delta surge, the WHO’s Access to COVID-19 Tools Accelerator is launching the Rapid ACT-Accelerator Delta Response, or RADAR, and issuing an urgent call for 7.7 billion U.S. dollars for tests, treatments and vaccines. 

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COVAX and World Bank to Accelerate Vaccine Access for Developing Countries

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COVAX and the World Bank will accelerate COVID-19 vaccine supply for developing countries through a new financing mechanism that builds on Gavi’s newly designed AMC cost-sharing arrangement. This allows AMC countries to purchase doses beyond the fully donor-subsidized doses they are already receiving from COVAX.

COVAX will now be able to make advance purchases from vaccine manufacturers based on aggregated demand across countries, using financing from the World Bank and other multilateral development banks. Participating developing countries will have greater visibility of available vaccines, quantities available, and future delivery schedules, enabling them to secure doses earlier, and prepare and implement vaccination plans more effectively.

This important and timely financing mechanism, made possible now by the World Bank and Gavi teaming up on the AMC cost-sharing arrangement, will allow COVAX to unlock additional doses for low- and middle-income countries,” said Dr. Seth Berkley, CEO, Gavi, the Vaccine Alliance. “As we move beyond initial targets and work to support countries’ efforts to protect increasingly large portions of their populations, World Bank financing will help us advance further towards our goal of bringing COVID-19 under control.”

The scalable mechanism brings together COVAX’s ability to negotiate advance purchase agreements with vaccine manufacturers with the World Bank’s ability to provide predictable financing to countries for vaccine purchase, deployment and broader health systems investments. The new mechanism will mitigate risks and uncertainties in country demand and financing ability.

Accessing vaccines remains the single greatest challenge that developing countries face in protecting their people from the health, social, and economic impacts of the COVID-19 pandemic,” said World Bank Group President David Malpass. “This mechanism will enable new supplies and allow countries to speed up the purchase of vaccines. It will also provide transparency about vaccine availability, prices, and delivery schedules. This is crucial information as governments implement their vaccination plans.”

Countries with approved World Bank vaccine projects that confirm the purchase of additional doses through COVAX will agree with COVAX on the number of doses of a specific vaccine as well as related windows of delivery. On receiving a request from the country, the World Bank will provide COVAX a payment confirmation, allowing COVAX to make advance purchases of large amounts of vaccine doses with manufacturers at competitive prices.

Under the cost-sharing arrangement for AMC countries (92 low- and middle-income countries), COVAX plans to make available up to 430 million additional doses, or enough to fully vaccinate 250 million people, for delivery between late 2021 and mid-2022. There will be several supply offerings where countries will have the opportunity to select and commit to procuring specific vaccines that align with their preferences.

COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization (WHO). The World Bank and COVAX will work in partnership with UNICEF and the PAHO Revolving Fund as key implementing partners to ensure safe vaccine delivery and supply of materials such as syringes, safety boxes and other items essential for vaccination campaigns.

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Study Finds That India Might Have Half Of All Covid-19 Deaths Worldwide

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© UNICEF/Vinay

On July 20th, an analysis that was published of India’s “excess mortality estimates from three different data sources from the pandemic’s start through June 2021 … yields an estimate of 4.9 million excess deaths.” As-of July 20th, the total number of deaths that had been officially reported worldwide from Covid-19 was 4,115,391, and only 414,513 (10%) of those were in India. If this new study is correct, then the possibility exists that around half of all deaths that have occurred, thus far, from Covid-19, could be in India, not merely the currently existing 10% that’s shown in the official figures.

This study doesn’t discuss why the actual number of deaths in India from Covid-19 might be around ten times higher than the official Indian figures, but one reason might be a false attribution of India’s greatly increased death-rate from the Covid-19 epidemic not to Covid-19 but to other causes, such as to Covid-19-related illnesses.

The new study is titled “Three New Estimates of India’s All-Cause Excess Mortality during the COVID-19 Pandemic”, and the detailed version of it can be downloaded here.   The study was funded by U.S.-and-allied billionaires and their foundations and corporations, and by governments that those billionaires also might control. However, this doesn’t necessarily mean that its methodology is in any way unscientific or otherwise dubious. The study raises serious questions — it does not, in and of itself, answer any. It’s a serious scientific study.

On 1 August 2020, I headlined “India and Brazil Are Now the Global Worst Coronavirus Nations”, and reported that, “India and Brazil have now overtaken the United States as the world’s worst performers at controlling the cononavirus-19 plague. The chart of the numbers of daily new cases in India shows the daily count soaring more than in any other country except Brazil, whereas in the United States, the daily number of new cases has plateaued ever since it hit 72,278 on July 10th, three weeks ago.” At that time, there was great pressure upon India’s Government to stop the alarming acceleration in the daily numbers of people who were officially counted as being patients (active cases) from the disease, and of dying from it. One way that a government can deal with such pressures is by mis-classifying cases, and deaths, from a disease, as being due to other causes, instead.

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