Wendy Reaser: Struggling with Obesity in Canada 03/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Wendy Reaser One time, as Wendy Reaser was visiting the emergency room, she heard a specialist describing her as “fat and lazy,” adding that she did not want to put the work into being healthy. This experience, as well as many other unpleasant interactions with health professionals, left Wendy discouraged and traumatized. “For many years, this statement had me convinced that because I’m living with obesity, I didn’t have the right to care from medical professionals,” she shares in the NCD Diaries project, an initiative launched by the NCD Alliance. “I was convinced that nothing could be done and I wasn’t worth saving.” NCDs (noncommunicable diseases) are diseases that are not transmissible from person to person and they represent the first cause of death and disability worldwide. The NCD Diaries project is meant to support individuals like Wendy, so that they can share their lived experiences of NCDs, drawing on their unique local contexts, challenges faced and their aspirations and recommendations to drive change on NCDs. Canada, where Wendy lives, provides its citizens with universal healthcare coverage. “While this is fantastic because everyone has access to treatment, it doesn’t always mean that you get treated well,” Wendy writes. “Living with obesity is a daily struggle physically and mentally,” she explains. “Not only do we have to live with our shame and self-loathing, but we also must live with the judgement of those around us. Often, we are made to feel that we aren’t deserving of medical help, with many health care providers having been trained to tell us to simply ‘eat less and move more’.” Luckily for Wendy, she eventually found doctors with a different approach. “One day I visited my family doctor, who had been with us for about a year, to express concern about symptoms I was experiencing that were noticeable in my dad prior to his death from a heart attack,” she recalls. “I expected her to say that it was my weight, that I had to eat less and exercise more. I didn’t expect her to sit up and pay attention, and to immediately put in an urgent referral to a cardiologist. But that’s exactly what she did.” The cardiologist explained to Wendy that her heart was enlarged because she had sleep apnea, so her lungs were lacking oxygen. “I’d just started sleep apnea treatment 6 months before seeing him,” she writes. “He was confident that if I continued this treatment, ‘tweaked my eating and maybe moved around just a little more,’ my heart would be fine in under a year.” Wendy emphasizes that the doctor’s words saved her life. “It’s interactions like these that began to restore my confidence in navigating my care journey, and my faith in the medical profession,” she explains. Health professionals, she argues, need better training to provide care empathetically and effectively for people living with obesity. “Healthcare providers must accept that people living with obesity are not fat and lazy,” Wendy says. “There are several factors including genetics, medication, and even monetary constraints that can and do contribute to someone becoming obese. There’s a way to discuss obesity-related issues respectfully and helpfully, that doesn’t leave a deflated feeling of failure.” Read Wendy Reaser’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. UN Environment: Investments in ‘Nature-Based’ Climate Solutions Must Double by 2025 02/12/2022 Stefan Anderson Climate, biodiversity, and land degradation goals will be out of reach unless investments into nature-based solutions quickly ramp up to $384 billion/year by 2025, more than double of the current $154 billion/year, according to UN Environment Programme. A new report by the United Nations Environment Programme warns that investment in nature-based solutions must double by 2025 if the world is to limit global warming to 1.5°C, as well as halting biodiversity loss and progressively increasing land degradation. The report comes a week before world leaders will gather at the UN Biodiversity Conference (COP15) in Montreal, Canada, where they are set to negotiate an agreement that aims to halt and reverse biodiveristy loss by 2030. UNEP is calling on governments to agree on a clear framework for countries to require the financial sector to align its activities with ‘nature positive’ goals. “The science is undeniable. As we transition to net-zero emissions by 2050, we must also reorient all human activity to ease the pressure on the natural world on which we all depend,” said Inger Andersen, Executive Director of UNEP. “This requires governments, business and finance to massively step up investments in nature-based solutions because investments in nature are investments in securing the future for generations to follow.” Nature-based solutions are actions to protect, manage, or restore natural ecosystems, and are already well-documented to be critical to any response to climate change. The World Bank estimates that nature-based solutions can reduce by 37% the carbon emissions reductions that are needed by 2030 to meet the Paris Agreement goals. The Intergovernmental Panel on Climate Change (IPCC) has also pointed to nature-based solutions, such as biodiversity preservation, as key to realistic emissions reductions. “Phasing out coal and decarbonizing the energy systems will not be enough without adjacent massive investments into nature-based solutions,” the report found. “Politicians, business and finance leaders and citizens globally must transform their relationship with nature to work with it rather than against it.” Nature-negative expenditures are 3 to 7 times higher than nature-based solution investment Governments need to scale-down environmentally harmful subsidies and investments, and increased nature based solutions (Nbs) if 1.5C is to remain within reach. While the world faces the overlapping planetary crises of climate change, biodiversity loss and pollution, nature-negative expenditures are 3 to 7 times larger than current investments in nature-based solutions, the report found. With the impacts of these crises already being felt by millions of people around the world, particularly the most vulnerable, UNEP said immediate action is required to begin mitigating and reversing the most harmful impacts. Government expenditures on harmful subsidies to fisheries, agriculture and fossil fuels is estimated at $500 billion to $1 trillion annually. Harmful subsidies are highest in the energy and agricultural sectors, estimated at $340 to $530 billion and around $500 billion per year respectively. By contrast, investment in nature based solutions (Nbs) currently are estimated at just $154 billion annually. “These flows severely undermine efforts to achieve critical environmental targets,” the report warns. “Delayed action is no longer an option in the face of the devastating effects of climate change, the extinction crisis and severe land degradation globally.” This warning is the latest in a series of dire calls to action by UNEP. Its adaptation and emissions gap reports equally stressed the need for immediate action if any hopes of averting climate disaster are to be kept alive. “We had our chance to make incremental changes, but that time is over,” Andersen said at a press conference launching the UNEP emissions gap report in late October, which benchmarked the gap between countries’ actual emissions and needed reductions to keep 1.5C alive. “Only a root-and-branch transformation of our economies and societies can save us from accelerating the climate disaster.” Private sector must step up as governments faces overlapping crises Private capital must start investing in harnessing the power of nature to reduce and remove emissions, restore degraded land and seascapes and turn the tide on biodiversity loss, the report found. The UNEP report reveals that private capital represents just 17% of total investments into nature-based solutions. Governments currently provide the other 83%, but the report stresses they will be unlikely to be able to significantly scale up funding due to current global financial challenges linked to war, debt, and poverty. As a result, private funding for nature-based solutions will have make-up the shortfall, requiring an increase by “several orders of magnitude” in the coming years. Total investments in nature-based solutions will need to hit $384 billion by 2050, more than double the present level of $154 billion annually, the report concludes. The roadmap provided by the report calls for ramping up private capital investments in sustainable supply chains, offsetting unavoidable impacts, reducing activities with negative climate and biodiversity impacts, and investing in “net zero” and “nature positive” activities. This will require a U-turn from the current state of private financial flows. “While robust evidence is lacking, it is widely recognized that private finance flows are predominantly negative for nature and almost certainly exacerbate the situation,” the report states. “These flows severely undermine efforts to achieve critical environmental targets,” the report states. “As the IMF warns of the ‘darkest hour’ in 2023 for global growth, this report is a reminder that many short-term efforts to boost GDP by governments, without attention to the fact that nature underpins many economies, will impose greater costs for both present and future generations in years to come,” the UNEP document concludes. Investment in protecting planet’s oceans disproportionately low The trajectory of annual nature-based solution investment needs to limit climate change to below 1.5°C, haltbiodiversity loss and achieve land degradation neutrality, $ billion (2022 US$). The UNEP analysis also found just 9% of investment in nature-based solutions are directed towards marine ecosystems, a disproportionately low amount given the critical role of oceans in climate mitigation, adaptation, food security, and biodiversity conservation. The Earth’s oceans cover over 70% of the planet’s surface, absorb around 25% of all CO2 emissions, and provide 17% of the world’s protein. Since the start of the Industrial Revolution, oceans have absorbed a third of human carbon dioxide emissions, making them one of the largest carbon sinks, topped only by global rainforests. The lack of investment in marine protection comes at a time of crisis for the world’s oceans. Projections show that by 2050, our oceans may contain more plastics than fish. These will not only suffocate marine life, but also phytoplankton, the microorganisms at the heart of oceans’ abilities to absorb carbon dioxide, as forests and plants do on dry land. As millions of tons of plastic break down in oceans across the world, uncounted quantities of microplastics are infiltrating phytoplankton, blocking sunlight-absorbing mechanisms, which in turn prevents the process of photosynthesis, and damages their ability to capture carbon in the seas. Yet current annual investment in marine protected areas sits at just $980 million, as compared to protection efforts in terrestrial systems, which receive almost US$23 billion annually. US$8–11 billion is needed to increase marine protected areas to 30% by 2030, the report concludes. “While the world is enduring multiple crises, this report provides clarity,” Jochen Flasbarth, State Secretary in the German Federal Ministry for Economic Cooperation and Development (BMZ), said. “It shows that by significantly increasing public and private investments in nature-based solutions, it is possible to tackle climate change, biodiversity loss and land degradation – and at the same time harness many societal and economic benefits. We need to act now.” Image Credits: UNEP. How Does Corruption Affect Health Systems Around the World? 02/12/2022 Editorial team When Patty García was a medical student in Peru some 30 years ago, she was already aware of the detrimental effect of corruption on health systems. “Back then, the corruption related to the distribution of drugs,” Garcia, who would go on to become her country’s Health Minister in 2016, shares during the latest episode of the “Global Health Matters” podcast with host Garry Aslanyan. “Because at that point resources were scarce, probably it was not seen as a big issue because there was not much to steal. But when I became Minister of Health, I realised the magnitude of the problem.” García, who currently is a professor at the School of Public Health at Cayetano Heredia University in Lima, joins Aslanyan, together with Monica Kirya, a lawyer and the Senior Program Adviser at the U4 Anti-Corruption Resource Centre in Norway, as well as Jonathan Cushing, Head of the Transparency International Health Program. “According to Transparency International, $500 billion in public health spending is estimated to be lost globally every year due to corruption,” Aslanyan remarked. “It has been labelled the disease of the health system, hindering and preventing progress towards universal health coverage.” Fighting corruption, all the guests agreed, is essential to achieve universal health coverage. Corruption as a matter of life and death According to Kirya, it is important to consider the phenomenon as a matter of life and death. “You can look at it from the perspective of an expectant mother in labour, or an accident victim bleeding profusely who can’t access urgently needed health care simply because there are no doctors,” she said, sharing the experience of her native Uganda. “One of the reasons why there are no or very few doctors in public health facilities in Uganda increasingly has to do with corruption. It became clear from the research I’ve done that medical graduates are having to pay huge bribes to district service commissions to be recruited.” While health workers are often considered amongst those responsible for corruption, they are also one of its victims, Kirya argues. In order to fight corruption effectively, it is crucial to understand how widespread and complex the phenomenon is. “We’ve absolutely got to get away from this idea that corruption just happens in low-resource settings and low-resource systems,” said Cushing, adding that while “petty bribery” might be more visible, corruption happens everywhere. “It’s much more perhaps more complex, more hidden in higher income countries, but it happens,” he added. “Until we address that, we’re not going to get anywhere.” García revealed that as health minister, she experienced how difficult dismantling the networks behind widespread corruption can be. “I was really concerned about the lack of medications at the health centres, while I knew that we have had a very important process in which we bought medications for all the country,” she recalled. “We started an investigation and we found an illegal operation that was removing the drugs from storage and public hospital pharmacies and placing them in private pharmacies,” she added. “I was working with the Ministry of Internal Affairs and with the police; it was like in the movies.” However, as soon as she left office about 14 months after she was appointed, the investigation was called off. “The problems are still ongoing,” she concluded. The need for leaders with integrity Garcia, Kirya, and Cushing agreed on how hard and complex fighting corruption effectively is, but also stated that this reality should not deter anyone from pursuing the mission. “We can’t afford to be pessimistic,” said Kirya. “We can’t just give up.” “I think that my key call is transparency and leadership,” added Cushing. “We need to have integral leaders. Leaders who are leaders with integrity.” Listen to previous episodes on the Health Policy Website >> Learn more about “Global Health Matters” podcast>> Image Credits: Global Health Matters Podcast, Courtesy of TDR. Twenty Years On, HIV Activist is Still Fighting for Access to Cheaper Medicine 01/12/2022 Kerry Cullinan HIV activist Hazel Tau Twenty years ago, Hazel Tau, a young South African living with HIV, and her peers had little chance of getting antiretroviral (ARV) treatment because it was completely unaffordable. The South African price for just one of the three ARV drugs she needed, AZT, was 665% higher than the best-priced generic available elsewhere in the world. Only around 20,000 South Africans with private healthcare were on ARVs at the time because of the price. So Tau, an activist with the Treatment Action Campaign, agreed to be one of the public faces of a challenge to the price of ARVs – cleverly brought as a complaint to the Competition Commission alleging that two pharmaceutical companies were charging excessive prices for first-line ARVs. At the time, then-president Thabo Mbeki disputed that HIV caused AIDS and claimed that ARVs were poison, so pressuring the government to act on drug prices was a non-starter. The targets were GlaxoSmithKline South Africa and Boehringer Ingelheim, with Tau and others complaining that they had contravened the country’s Competition Act by abusing their dominant market positions on ARV prices. The SA Competition Commission’s Mapato Ramakgopa explained that the commission agreed with Tau and others, and had sought an order from the competition tribunal to compel the firms to grant voluntary licences to allow generic manufacturers to make genetic ARVs in return for a reasonable royalty. “The firms were found to have abused market dominance and fortunately, before the case could be heard by the tribunal, the manufacturers settled the matter and agreed to allow licences for generic and local manufacturers,” said Ramakgopa. Bittersweet victory “It was a bittersweet experience because of everyone who could not be saved,” said Tau, speaking at a commemorative event on Thursday. “I lost friends, family, colleagues. We lost millions of people who were breadwinners. But I will say I was happy with the outcome.” Finally, she and others could look forward to a life with access to affordable treatment. But Tau’s struggle for treatment access continues today as she is fighting for cheaper cancer drugs. “We know that, in developed countries, they’ve got cheaper drugs that can help people who have got cancer of different types, but we still have to pay it so I’m not feeling good about that,” said Tau. She is also still fighting the stigma faced by people living with HIV – and says that it is time for stand-alone HIV clinics – largely the result of special HIV funding – to be integrated as part of chronic care to spare those who need HIV care from being conspicuous when they go for treatment. “I blame us for having that HIV clinic. I wish HIV was just dealt with like other chronic diseases, normally without saying ‘this is an HIV thing’ because the stigma started there,” says Tau. Speaking on World AIDS Day, Tau said that she honoured those who had passed on and those newly infected and wished that AIDS awareness campaigns were active every day. Access to affordable medicine Access to affordable medicine continues to haunt people from poorer countries, as the COVID-19 pandemic showed when millions of people in low and middle-income countries could not get vaccines as these had all been bought by wealthy countries. The question of intellectual property (IP) rights on essential medicine is as burning an issue today as it was during the AIDS era. Fatima Hassan, director of the Health Justice Initiative (HJI), was one of the lawyers representing Tau and others – and more recently, has been campaigning for wider access to COVID-19 vaccines and therapeutics. Fatima Hassan ‘The reason we brought the case was because we saw the ‘Lazarus’ drugs. We saw them working for people in the USA. We saw them working for people in Europe.,” said Hassan. “We saw what Brazilian and Thai activists were doing to try to get compulsory measures in place for their governments to introduce generic therapies into their country. But our government was having none of that. It was in denial of the science and it refused to implement a public sector programme, which is the reason why we had to focus on the price of abuse in the private sector.” Hassan says that today’s struggles include fighting for access to expensive cancer treatments, exorbitant cystic fibrosis drugs and cabotegravir, an HIV prevention injection that received regulatory approval for use in South Africa on Thursday but remains too expensive for most. “Pharmaceutical companies have these IP monopolies which then means that we’ve got to continuously fight them on pricing because, in the absence of our government, taking the necessary executive action or issuing compulsory licences, we’re always going to have to rely on civil society or the Competition Commission to deal with the abuse of dominance, capture of the market and excessive pricing,” said Hassan. Africa’s Progress Against Maternal and Infant Mortality Has ‘Flatlined’ 01/12/2022 Kerry Cullinan Millions of African women don’t have access to skilled birth attendants. In the past decade, Africa’s progress against maternal and infant mortality has flatlined, and it will need to reduce maternal deaths by a massive 86%, and more than halve the deaths of babies to reach global targets by 2030. This is according to the Atlas of African Health Statistics 2022 released by the World Health Organization’s (WHO) Africa region on Thursday. The atlas assessed the nine targets related to the Sustainable Development Goal (SDG) on health, and estimates that 390 women will die in childbirth for every 100 000 live births by 2030 in sub-Saharan Africa, based on the current rate of progress. This is over five times higher than the 2030 SDG target of fewer than 70 maternal deaths per 100 000 live births, and exponentially higher than the average of 13 deaths per 100 000 live births witnessed in Europe in 2017. The region’s infant mortality rate is 72 per 1000 live births, with a slow annual decline of 3.1%. At this rate, there will be 54 deaths per 1000 live births by 2030, more than double the target of fewer than 25 per 1000. WHO Africa official Dr Humphrey Karamagi described the slowdown in progress as “drastic”, with the likelihood of Africa reaching global targets being unlikely. A slowdown in the progress made during the past decade against maternal & infant mortality is projected in the #African 🌍 Region, a new WHO report released today finds ➡️ https://t.co/6W7eTEaANk pic.twitter.com/nOomg9jhRP — WHO African Region (@WHOAFRO) December 1, 2022 Incomplete abortions The main cause of maternal death is haemorrhaging, followed by sepsis, said Dr Benjamin Tsofa, Principal Research Officer at Kenya Medical Research Institute (KEMRI), who also addressed the briefing. Some of this bleeding was caused by “incomplete abortions” – abortion is illegal in most African countries – but Karamagi said that it was impossible to calculate what percentage this was. “There are different policies in different countries around safe abortion, and the pattern will differ really on a country-by-country basis,” said Karamagi. “What we do know is that the major cause of maternal deaths at present is bleeding, particularly during labour, [whether] it’s due to unsafe abortion or it’s due to lack of appropriate care and so on. I think it’s important that we unpack what is driving that in the different countries and address it.” Karamagi added that millions of women in the region did not have access to antenatal care – access ranged from 30-90% across countries – despite the evidence that it plays a major role in reducing maternal and neonatal mortality. Pandemic’s effect However, between 2000 and 2010, Africa made progress on a number of health issues: under-5 mortality fell by 35%, neonatal death rates dropped by 21%, and maternal mortality declined by 28%. Since then, however, “advances in all three targets have flatlined” – and more recently, the COVID-19 pandemic has undermined progress. “Crucial health services such as postnatal care for women and newborns, neonatal intensive care units, and antenatal care services, immunisation services were disrupted during the pandemic,” notes the report. “Since 2021, Africa has also faced a resurgence in vaccine-preventable disease outbreaks. Measles cases rose by 400% between January and March 2022 compared with the same period the year before.” Dr Matshidiso Moeti, WHO Regional Director for Africa., warned: “It is crucial that governments make a radical course correction, surmount the challenges and speed up the pace towards the health goals. These goals aren’t mere milestones, but the very foundations of healthier life and well-being for millions of people.” Image Credits: Elizabeth Poll/MMV. Air Pollution Linked to Nearly Half of all Stillbirths 01/12/2022 Stefan Anderson The new study is the latest addition to an ever-growing mountain of evidence documenting the negative effects of air pollutants on human health. In 2020, UNICEF estimated that “a stillbirth occurs every 16 seconds somewhere in the world.” A new study has linked air pollution to nearly half of them. The study of 137 countries is the first global analysis to assess the number of fetal deaths, putting into numbers the already documented link between fine particulate matter (PM2.5) concentrations and stillbirths. PM2.5 is primarily produced through the burning of fossil fuels. The United Nations estimates around two million stillbirths occur every year, and describes the global burden of stillbirths as a ‘neglected tragedy’. Some 98% of stillbirths are estimated to occur in low- and middle-income countries across Asia, Africa, and Latin America. Progress in combatting the crisis has stalled, and stillbirths continue to receive little attention on the global health agenda. Despite their impacts on millions around the world, stillbirths are not included in the Millennium Development Goals targets. “Current efforts to prevent stillbirth focus on medical service improvements but compared to clinical risk factors, environmental ones are usually unseen.” Dr Tao Xue, the first author of the study, told the Guardian. “Clean air policies, which have been enacted in some countries, such as China, can prevent stillbirths. In addition, personal protections against air pollution, i.e. wearing masks, installing air purifiers, and avoiding going outside when air pollution occurs could also protect vulnerable pregnant women.” A neglected tragedy The United Nations estimates 98% of all stillbirths occur in low-and middle-income countries. The study estimates cutting air pollution to the World Health Organization’s recommended limits could prevent 710,000 stillbirths a year, but the exact mechanisms behind how air pollution causes stillbirths are still unclear. The researchers found PM2.5 particles could be passing from the mother to the foetus through the placenta, which may not only harm the placenta but also potentially cause “irreversible embryonic damage.” A 2018 study found toxic pollutant particles in the lungs, livers and brains of foetuses. Further, PM2.5 exposure during pregnancy could also reduce oxygen transfer to the foetus or cause placental abnormalities – all possible causes of stillbirths. The study also stressed that the impacts of stillbirths stretch far beyond the strictly medical. Stillbirths have well-documented links to psychological conditions like anxiety, grief, and post-traumatic stress disorders, and the economic burdens resulting from healthcare costs and the inability to work affect individuals and their families – often driving sex inequalities as a consequence. Air pollution is a global epidemic Mounting scientific evidence on the adverse health effects of air pollution shows cutting PM2.5 concentrations would save the lives of millions. This latest study adds to a mounting pile of evidence on the harms of air pollution. It kills nearly seven million people every year, penetrates the brain and lungs of fetuses, is correlated with adverse birth outcomes like miscarriages, pre-mature birth and low birthweight, and is linked to adverse brain development in young children. In 2021, the World Health Organization slashed its limit on air pollution concentration in half, urging nations to tackle polluted air to save millions of lives. WHO estimates 99% of the global population now breathes air beyond its recommended limit. Earlier this year, the Lancet found air pollution is the world’s largest environmental risk factor for disease and premature death. While the exact number of stillbirths that could be prevented through meaningful reductions in air pollution is unknown, the study is the latest of a long series of scientific footnotes showing that slashing PM2.5 concentrations would improve the health of millions around the world – and the most vulnerable populations most of all. Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
UN Environment: Investments in ‘Nature-Based’ Climate Solutions Must Double by 2025 02/12/2022 Stefan Anderson Climate, biodiversity, and land degradation goals will be out of reach unless investments into nature-based solutions quickly ramp up to $384 billion/year by 2025, more than double of the current $154 billion/year, according to UN Environment Programme. A new report by the United Nations Environment Programme warns that investment in nature-based solutions must double by 2025 if the world is to limit global warming to 1.5°C, as well as halting biodiversity loss and progressively increasing land degradation. The report comes a week before world leaders will gather at the UN Biodiversity Conference (COP15) in Montreal, Canada, where they are set to negotiate an agreement that aims to halt and reverse biodiveristy loss by 2030. UNEP is calling on governments to agree on a clear framework for countries to require the financial sector to align its activities with ‘nature positive’ goals. “The science is undeniable. As we transition to net-zero emissions by 2050, we must also reorient all human activity to ease the pressure on the natural world on which we all depend,” said Inger Andersen, Executive Director of UNEP. “This requires governments, business and finance to massively step up investments in nature-based solutions because investments in nature are investments in securing the future for generations to follow.” Nature-based solutions are actions to protect, manage, or restore natural ecosystems, and are already well-documented to be critical to any response to climate change. The World Bank estimates that nature-based solutions can reduce by 37% the carbon emissions reductions that are needed by 2030 to meet the Paris Agreement goals. The Intergovernmental Panel on Climate Change (IPCC) has also pointed to nature-based solutions, such as biodiversity preservation, as key to realistic emissions reductions. “Phasing out coal and decarbonizing the energy systems will not be enough without adjacent massive investments into nature-based solutions,” the report found. “Politicians, business and finance leaders and citizens globally must transform their relationship with nature to work with it rather than against it.” Nature-negative expenditures are 3 to 7 times higher than nature-based solution investment Governments need to scale-down environmentally harmful subsidies and investments, and increased nature based solutions (Nbs) if 1.5C is to remain within reach. While the world faces the overlapping planetary crises of climate change, biodiversity loss and pollution, nature-negative expenditures are 3 to 7 times larger than current investments in nature-based solutions, the report found. With the impacts of these crises already being felt by millions of people around the world, particularly the most vulnerable, UNEP said immediate action is required to begin mitigating and reversing the most harmful impacts. Government expenditures on harmful subsidies to fisheries, agriculture and fossil fuels is estimated at $500 billion to $1 trillion annually. Harmful subsidies are highest in the energy and agricultural sectors, estimated at $340 to $530 billion and around $500 billion per year respectively. By contrast, investment in nature based solutions (Nbs) currently are estimated at just $154 billion annually. “These flows severely undermine efforts to achieve critical environmental targets,” the report warns. “Delayed action is no longer an option in the face of the devastating effects of climate change, the extinction crisis and severe land degradation globally.” This warning is the latest in a series of dire calls to action by UNEP. Its adaptation and emissions gap reports equally stressed the need for immediate action if any hopes of averting climate disaster are to be kept alive. “We had our chance to make incremental changes, but that time is over,” Andersen said at a press conference launching the UNEP emissions gap report in late October, which benchmarked the gap between countries’ actual emissions and needed reductions to keep 1.5C alive. “Only a root-and-branch transformation of our economies and societies can save us from accelerating the climate disaster.” Private sector must step up as governments faces overlapping crises Private capital must start investing in harnessing the power of nature to reduce and remove emissions, restore degraded land and seascapes and turn the tide on biodiversity loss, the report found. The UNEP report reveals that private capital represents just 17% of total investments into nature-based solutions. Governments currently provide the other 83%, but the report stresses they will be unlikely to be able to significantly scale up funding due to current global financial challenges linked to war, debt, and poverty. As a result, private funding for nature-based solutions will have make-up the shortfall, requiring an increase by “several orders of magnitude” in the coming years. Total investments in nature-based solutions will need to hit $384 billion by 2050, more than double the present level of $154 billion annually, the report concludes. The roadmap provided by the report calls for ramping up private capital investments in sustainable supply chains, offsetting unavoidable impacts, reducing activities with negative climate and biodiversity impacts, and investing in “net zero” and “nature positive” activities. This will require a U-turn from the current state of private financial flows. “While robust evidence is lacking, it is widely recognized that private finance flows are predominantly negative for nature and almost certainly exacerbate the situation,” the report states. “These flows severely undermine efforts to achieve critical environmental targets,” the report states. “As the IMF warns of the ‘darkest hour’ in 2023 for global growth, this report is a reminder that many short-term efforts to boost GDP by governments, without attention to the fact that nature underpins many economies, will impose greater costs for both present and future generations in years to come,” the UNEP document concludes. Investment in protecting planet’s oceans disproportionately low The trajectory of annual nature-based solution investment needs to limit climate change to below 1.5°C, haltbiodiversity loss and achieve land degradation neutrality, $ billion (2022 US$). The UNEP analysis also found just 9% of investment in nature-based solutions are directed towards marine ecosystems, a disproportionately low amount given the critical role of oceans in climate mitigation, adaptation, food security, and biodiversity conservation. The Earth’s oceans cover over 70% of the planet’s surface, absorb around 25% of all CO2 emissions, and provide 17% of the world’s protein. Since the start of the Industrial Revolution, oceans have absorbed a third of human carbon dioxide emissions, making them one of the largest carbon sinks, topped only by global rainforests. The lack of investment in marine protection comes at a time of crisis for the world’s oceans. Projections show that by 2050, our oceans may contain more plastics than fish. These will not only suffocate marine life, but also phytoplankton, the microorganisms at the heart of oceans’ abilities to absorb carbon dioxide, as forests and plants do on dry land. As millions of tons of plastic break down in oceans across the world, uncounted quantities of microplastics are infiltrating phytoplankton, blocking sunlight-absorbing mechanisms, which in turn prevents the process of photosynthesis, and damages their ability to capture carbon in the seas. Yet current annual investment in marine protected areas sits at just $980 million, as compared to protection efforts in terrestrial systems, which receive almost US$23 billion annually. US$8–11 billion is needed to increase marine protected areas to 30% by 2030, the report concludes. “While the world is enduring multiple crises, this report provides clarity,” Jochen Flasbarth, State Secretary in the German Federal Ministry for Economic Cooperation and Development (BMZ), said. “It shows that by significantly increasing public and private investments in nature-based solutions, it is possible to tackle climate change, biodiversity loss and land degradation – and at the same time harness many societal and economic benefits. We need to act now.” Image Credits: UNEP. How Does Corruption Affect Health Systems Around the World? 02/12/2022 Editorial team When Patty García was a medical student in Peru some 30 years ago, she was already aware of the detrimental effect of corruption on health systems. “Back then, the corruption related to the distribution of drugs,” Garcia, who would go on to become her country’s Health Minister in 2016, shares during the latest episode of the “Global Health Matters” podcast with host Garry Aslanyan. “Because at that point resources were scarce, probably it was not seen as a big issue because there was not much to steal. But when I became Minister of Health, I realised the magnitude of the problem.” García, who currently is a professor at the School of Public Health at Cayetano Heredia University in Lima, joins Aslanyan, together with Monica Kirya, a lawyer and the Senior Program Adviser at the U4 Anti-Corruption Resource Centre in Norway, as well as Jonathan Cushing, Head of the Transparency International Health Program. “According to Transparency International, $500 billion in public health spending is estimated to be lost globally every year due to corruption,” Aslanyan remarked. “It has been labelled the disease of the health system, hindering and preventing progress towards universal health coverage.” Fighting corruption, all the guests agreed, is essential to achieve universal health coverage. Corruption as a matter of life and death According to Kirya, it is important to consider the phenomenon as a matter of life and death. “You can look at it from the perspective of an expectant mother in labour, or an accident victim bleeding profusely who can’t access urgently needed health care simply because there are no doctors,” she said, sharing the experience of her native Uganda. “One of the reasons why there are no or very few doctors in public health facilities in Uganda increasingly has to do with corruption. It became clear from the research I’ve done that medical graduates are having to pay huge bribes to district service commissions to be recruited.” While health workers are often considered amongst those responsible for corruption, they are also one of its victims, Kirya argues. In order to fight corruption effectively, it is crucial to understand how widespread and complex the phenomenon is. “We’ve absolutely got to get away from this idea that corruption just happens in low-resource settings and low-resource systems,” said Cushing, adding that while “petty bribery” might be more visible, corruption happens everywhere. “It’s much more perhaps more complex, more hidden in higher income countries, but it happens,” he added. “Until we address that, we’re not going to get anywhere.” García revealed that as health minister, she experienced how difficult dismantling the networks behind widespread corruption can be. “I was really concerned about the lack of medications at the health centres, while I knew that we have had a very important process in which we bought medications for all the country,” she recalled. “We started an investigation and we found an illegal operation that was removing the drugs from storage and public hospital pharmacies and placing them in private pharmacies,” she added. “I was working with the Ministry of Internal Affairs and with the police; it was like in the movies.” However, as soon as she left office about 14 months after she was appointed, the investigation was called off. “The problems are still ongoing,” she concluded. The need for leaders with integrity Garcia, Kirya, and Cushing agreed on how hard and complex fighting corruption effectively is, but also stated that this reality should not deter anyone from pursuing the mission. “We can’t afford to be pessimistic,” said Kirya. “We can’t just give up.” “I think that my key call is transparency and leadership,” added Cushing. “We need to have integral leaders. Leaders who are leaders with integrity.” Listen to previous episodes on the Health Policy Website >> Learn more about “Global Health Matters” podcast>> Image Credits: Global Health Matters Podcast, Courtesy of TDR. Twenty Years On, HIV Activist is Still Fighting for Access to Cheaper Medicine 01/12/2022 Kerry Cullinan HIV activist Hazel Tau Twenty years ago, Hazel Tau, a young South African living with HIV, and her peers had little chance of getting antiretroviral (ARV) treatment because it was completely unaffordable. The South African price for just one of the three ARV drugs she needed, AZT, was 665% higher than the best-priced generic available elsewhere in the world. Only around 20,000 South Africans with private healthcare were on ARVs at the time because of the price. So Tau, an activist with the Treatment Action Campaign, agreed to be one of the public faces of a challenge to the price of ARVs – cleverly brought as a complaint to the Competition Commission alleging that two pharmaceutical companies were charging excessive prices for first-line ARVs. At the time, then-president Thabo Mbeki disputed that HIV caused AIDS and claimed that ARVs were poison, so pressuring the government to act on drug prices was a non-starter. The targets were GlaxoSmithKline South Africa and Boehringer Ingelheim, with Tau and others complaining that they had contravened the country’s Competition Act by abusing their dominant market positions on ARV prices. The SA Competition Commission’s Mapato Ramakgopa explained that the commission agreed with Tau and others, and had sought an order from the competition tribunal to compel the firms to grant voluntary licences to allow generic manufacturers to make genetic ARVs in return for a reasonable royalty. “The firms were found to have abused market dominance and fortunately, before the case could be heard by the tribunal, the manufacturers settled the matter and agreed to allow licences for generic and local manufacturers,” said Ramakgopa. Bittersweet victory “It was a bittersweet experience because of everyone who could not be saved,” said Tau, speaking at a commemorative event on Thursday. “I lost friends, family, colleagues. We lost millions of people who were breadwinners. But I will say I was happy with the outcome.” Finally, she and others could look forward to a life with access to affordable treatment. But Tau’s struggle for treatment access continues today as she is fighting for cheaper cancer drugs. “We know that, in developed countries, they’ve got cheaper drugs that can help people who have got cancer of different types, but we still have to pay it so I’m not feeling good about that,” said Tau. She is also still fighting the stigma faced by people living with HIV – and says that it is time for stand-alone HIV clinics – largely the result of special HIV funding – to be integrated as part of chronic care to spare those who need HIV care from being conspicuous when they go for treatment. “I blame us for having that HIV clinic. I wish HIV was just dealt with like other chronic diseases, normally without saying ‘this is an HIV thing’ because the stigma started there,” says Tau. Speaking on World AIDS Day, Tau said that she honoured those who had passed on and those newly infected and wished that AIDS awareness campaigns were active every day. Access to affordable medicine Access to affordable medicine continues to haunt people from poorer countries, as the COVID-19 pandemic showed when millions of people in low and middle-income countries could not get vaccines as these had all been bought by wealthy countries. The question of intellectual property (IP) rights on essential medicine is as burning an issue today as it was during the AIDS era. Fatima Hassan, director of the Health Justice Initiative (HJI), was one of the lawyers representing Tau and others – and more recently, has been campaigning for wider access to COVID-19 vaccines and therapeutics. Fatima Hassan ‘The reason we brought the case was because we saw the ‘Lazarus’ drugs. We saw them working for people in the USA. We saw them working for people in Europe.,” said Hassan. “We saw what Brazilian and Thai activists were doing to try to get compulsory measures in place for their governments to introduce generic therapies into their country. But our government was having none of that. It was in denial of the science and it refused to implement a public sector programme, which is the reason why we had to focus on the price of abuse in the private sector.” Hassan says that today’s struggles include fighting for access to expensive cancer treatments, exorbitant cystic fibrosis drugs and cabotegravir, an HIV prevention injection that received regulatory approval for use in South Africa on Thursday but remains too expensive for most. “Pharmaceutical companies have these IP monopolies which then means that we’ve got to continuously fight them on pricing because, in the absence of our government, taking the necessary executive action or issuing compulsory licences, we’re always going to have to rely on civil society or the Competition Commission to deal with the abuse of dominance, capture of the market and excessive pricing,” said Hassan. Africa’s Progress Against Maternal and Infant Mortality Has ‘Flatlined’ 01/12/2022 Kerry Cullinan Millions of African women don’t have access to skilled birth attendants. In the past decade, Africa’s progress against maternal and infant mortality has flatlined, and it will need to reduce maternal deaths by a massive 86%, and more than halve the deaths of babies to reach global targets by 2030. This is according to the Atlas of African Health Statistics 2022 released by the World Health Organization’s (WHO) Africa region on Thursday. The atlas assessed the nine targets related to the Sustainable Development Goal (SDG) on health, and estimates that 390 women will die in childbirth for every 100 000 live births by 2030 in sub-Saharan Africa, based on the current rate of progress. This is over five times higher than the 2030 SDG target of fewer than 70 maternal deaths per 100 000 live births, and exponentially higher than the average of 13 deaths per 100 000 live births witnessed in Europe in 2017. The region’s infant mortality rate is 72 per 1000 live births, with a slow annual decline of 3.1%. At this rate, there will be 54 deaths per 1000 live births by 2030, more than double the target of fewer than 25 per 1000. WHO Africa official Dr Humphrey Karamagi described the slowdown in progress as “drastic”, with the likelihood of Africa reaching global targets being unlikely. A slowdown in the progress made during the past decade against maternal & infant mortality is projected in the #African 🌍 Region, a new WHO report released today finds ➡️ https://t.co/6W7eTEaANk pic.twitter.com/nOomg9jhRP — WHO African Region (@WHOAFRO) December 1, 2022 Incomplete abortions The main cause of maternal death is haemorrhaging, followed by sepsis, said Dr Benjamin Tsofa, Principal Research Officer at Kenya Medical Research Institute (KEMRI), who also addressed the briefing. Some of this bleeding was caused by “incomplete abortions” – abortion is illegal in most African countries – but Karamagi said that it was impossible to calculate what percentage this was. “There are different policies in different countries around safe abortion, and the pattern will differ really on a country-by-country basis,” said Karamagi. “What we do know is that the major cause of maternal deaths at present is bleeding, particularly during labour, [whether] it’s due to unsafe abortion or it’s due to lack of appropriate care and so on. I think it’s important that we unpack what is driving that in the different countries and address it.” Karamagi added that millions of women in the region did not have access to antenatal care – access ranged from 30-90% across countries – despite the evidence that it plays a major role in reducing maternal and neonatal mortality. Pandemic’s effect However, between 2000 and 2010, Africa made progress on a number of health issues: under-5 mortality fell by 35%, neonatal death rates dropped by 21%, and maternal mortality declined by 28%. Since then, however, “advances in all three targets have flatlined” – and more recently, the COVID-19 pandemic has undermined progress. “Crucial health services such as postnatal care for women and newborns, neonatal intensive care units, and antenatal care services, immunisation services were disrupted during the pandemic,” notes the report. “Since 2021, Africa has also faced a resurgence in vaccine-preventable disease outbreaks. Measles cases rose by 400% between January and March 2022 compared with the same period the year before.” Dr Matshidiso Moeti, WHO Regional Director for Africa., warned: “It is crucial that governments make a radical course correction, surmount the challenges and speed up the pace towards the health goals. These goals aren’t mere milestones, but the very foundations of healthier life and well-being for millions of people.” Image Credits: Elizabeth Poll/MMV. Air Pollution Linked to Nearly Half of all Stillbirths 01/12/2022 Stefan Anderson The new study is the latest addition to an ever-growing mountain of evidence documenting the negative effects of air pollutants on human health. In 2020, UNICEF estimated that “a stillbirth occurs every 16 seconds somewhere in the world.” A new study has linked air pollution to nearly half of them. The study of 137 countries is the first global analysis to assess the number of fetal deaths, putting into numbers the already documented link between fine particulate matter (PM2.5) concentrations and stillbirths. PM2.5 is primarily produced through the burning of fossil fuels. The United Nations estimates around two million stillbirths occur every year, and describes the global burden of stillbirths as a ‘neglected tragedy’. Some 98% of stillbirths are estimated to occur in low- and middle-income countries across Asia, Africa, and Latin America. Progress in combatting the crisis has stalled, and stillbirths continue to receive little attention on the global health agenda. Despite their impacts on millions around the world, stillbirths are not included in the Millennium Development Goals targets. “Current efforts to prevent stillbirth focus on medical service improvements but compared to clinical risk factors, environmental ones are usually unseen.” Dr Tao Xue, the first author of the study, told the Guardian. “Clean air policies, which have been enacted in some countries, such as China, can prevent stillbirths. In addition, personal protections against air pollution, i.e. wearing masks, installing air purifiers, and avoiding going outside when air pollution occurs could also protect vulnerable pregnant women.” A neglected tragedy The United Nations estimates 98% of all stillbirths occur in low-and middle-income countries. The study estimates cutting air pollution to the World Health Organization’s recommended limits could prevent 710,000 stillbirths a year, but the exact mechanisms behind how air pollution causes stillbirths are still unclear. The researchers found PM2.5 particles could be passing from the mother to the foetus through the placenta, which may not only harm the placenta but also potentially cause “irreversible embryonic damage.” A 2018 study found toxic pollutant particles in the lungs, livers and brains of foetuses. Further, PM2.5 exposure during pregnancy could also reduce oxygen transfer to the foetus or cause placental abnormalities – all possible causes of stillbirths. The study also stressed that the impacts of stillbirths stretch far beyond the strictly medical. Stillbirths have well-documented links to psychological conditions like anxiety, grief, and post-traumatic stress disorders, and the economic burdens resulting from healthcare costs and the inability to work affect individuals and their families – often driving sex inequalities as a consequence. Air pollution is a global epidemic Mounting scientific evidence on the adverse health effects of air pollution shows cutting PM2.5 concentrations would save the lives of millions. This latest study adds to a mounting pile of evidence on the harms of air pollution. It kills nearly seven million people every year, penetrates the brain and lungs of fetuses, is correlated with adverse birth outcomes like miscarriages, pre-mature birth and low birthweight, and is linked to adverse brain development in young children. In 2021, the World Health Organization slashed its limit on air pollution concentration in half, urging nations to tackle polluted air to save millions of lives. WHO estimates 99% of the global population now breathes air beyond its recommended limit. Earlier this year, the Lancet found air pollution is the world’s largest environmental risk factor for disease and premature death. While the exact number of stillbirths that could be prevented through meaningful reductions in air pollution is unknown, the study is the latest of a long series of scientific footnotes showing that slashing PM2.5 concentrations would improve the health of millions around the world – and the most vulnerable populations most of all. Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
How Does Corruption Affect Health Systems Around the World? 02/12/2022 Editorial team When Patty García was a medical student in Peru some 30 years ago, she was already aware of the detrimental effect of corruption on health systems. “Back then, the corruption related to the distribution of drugs,” Garcia, who would go on to become her country’s Health Minister in 2016, shares during the latest episode of the “Global Health Matters” podcast with host Garry Aslanyan. “Because at that point resources were scarce, probably it was not seen as a big issue because there was not much to steal. But when I became Minister of Health, I realised the magnitude of the problem.” García, who currently is a professor at the School of Public Health at Cayetano Heredia University in Lima, joins Aslanyan, together with Monica Kirya, a lawyer and the Senior Program Adviser at the U4 Anti-Corruption Resource Centre in Norway, as well as Jonathan Cushing, Head of the Transparency International Health Program. “According to Transparency International, $500 billion in public health spending is estimated to be lost globally every year due to corruption,” Aslanyan remarked. “It has been labelled the disease of the health system, hindering and preventing progress towards universal health coverage.” Fighting corruption, all the guests agreed, is essential to achieve universal health coverage. Corruption as a matter of life and death According to Kirya, it is important to consider the phenomenon as a matter of life and death. “You can look at it from the perspective of an expectant mother in labour, or an accident victim bleeding profusely who can’t access urgently needed health care simply because there are no doctors,” she said, sharing the experience of her native Uganda. “One of the reasons why there are no or very few doctors in public health facilities in Uganda increasingly has to do with corruption. It became clear from the research I’ve done that medical graduates are having to pay huge bribes to district service commissions to be recruited.” While health workers are often considered amongst those responsible for corruption, they are also one of its victims, Kirya argues. In order to fight corruption effectively, it is crucial to understand how widespread and complex the phenomenon is. “We’ve absolutely got to get away from this idea that corruption just happens in low-resource settings and low-resource systems,” said Cushing, adding that while “petty bribery” might be more visible, corruption happens everywhere. “It’s much more perhaps more complex, more hidden in higher income countries, but it happens,” he added. “Until we address that, we’re not going to get anywhere.” García revealed that as health minister, she experienced how difficult dismantling the networks behind widespread corruption can be. “I was really concerned about the lack of medications at the health centres, while I knew that we have had a very important process in which we bought medications for all the country,” she recalled. “We started an investigation and we found an illegal operation that was removing the drugs from storage and public hospital pharmacies and placing them in private pharmacies,” she added. “I was working with the Ministry of Internal Affairs and with the police; it was like in the movies.” However, as soon as she left office about 14 months after she was appointed, the investigation was called off. “The problems are still ongoing,” she concluded. The need for leaders with integrity Garcia, Kirya, and Cushing agreed on how hard and complex fighting corruption effectively is, but also stated that this reality should not deter anyone from pursuing the mission. “We can’t afford to be pessimistic,” said Kirya. “We can’t just give up.” “I think that my key call is transparency and leadership,” added Cushing. “We need to have integral leaders. Leaders who are leaders with integrity.” Listen to previous episodes on the Health Policy Website >> Learn more about “Global Health Matters” podcast>> Image Credits: Global Health Matters Podcast, Courtesy of TDR. Twenty Years On, HIV Activist is Still Fighting for Access to Cheaper Medicine 01/12/2022 Kerry Cullinan HIV activist Hazel Tau Twenty years ago, Hazel Tau, a young South African living with HIV, and her peers had little chance of getting antiretroviral (ARV) treatment because it was completely unaffordable. The South African price for just one of the three ARV drugs she needed, AZT, was 665% higher than the best-priced generic available elsewhere in the world. Only around 20,000 South Africans with private healthcare were on ARVs at the time because of the price. So Tau, an activist with the Treatment Action Campaign, agreed to be one of the public faces of a challenge to the price of ARVs – cleverly brought as a complaint to the Competition Commission alleging that two pharmaceutical companies were charging excessive prices for first-line ARVs. At the time, then-president Thabo Mbeki disputed that HIV caused AIDS and claimed that ARVs were poison, so pressuring the government to act on drug prices was a non-starter. The targets were GlaxoSmithKline South Africa and Boehringer Ingelheim, with Tau and others complaining that they had contravened the country’s Competition Act by abusing their dominant market positions on ARV prices. The SA Competition Commission’s Mapato Ramakgopa explained that the commission agreed with Tau and others, and had sought an order from the competition tribunal to compel the firms to grant voluntary licences to allow generic manufacturers to make genetic ARVs in return for a reasonable royalty. “The firms were found to have abused market dominance and fortunately, before the case could be heard by the tribunal, the manufacturers settled the matter and agreed to allow licences for generic and local manufacturers,” said Ramakgopa. Bittersweet victory “It was a bittersweet experience because of everyone who could not be saved,” said Tau, speaking at a commemorative event on Thursday. “I lost friends, family, colleagues. We lost millions of people who were breadwinners. But I will say I was happy with the outcome.” Finally, she and others could look forward to a life with access to affordable treatment. But Tau’s struggle for treatment access continues today as she is fighting for cheaper cancer drugs. “We know that, in developed countries, they’ve got cheaper drugs that can help people who have got cancer of different types, but we still have to pay it so I’m not feeling good about that,” said Tau. She is also still fighting the stigma faced by people living with HIV – and says that it is time for stand-alone HIV clinics – largely the result of special HIV funding – to be integrated as part of chronic care to spare those who need HIV care from being conspicuous when they go for treatment. “I blame us for having that HIV clinic. I wish HIV was just dealt with like other chronic diseases, normally without saying ‘this is an HIV thing’ because the stigma started there,” says Tau. Speaking on World AIDS Day, Tau said that she honoured those who had passed on and those newly infected and wished that AIDS awareness campaigns were active every day. Access to affordable medicine Access to affordable medicine continues to haunt people from poorer countries, as the COVID-19 pandemic showed when millions of people in low and middle-income countries could not get vaccines as these had all been bought by wealthy countries. The question of intellectual property (IP) rights on essential medicine is as burning an issue today as it was during the AIDS era. Fatima Hassan, director of the Health Justice Initiative (HJI), was one of the lawyers representing Tau and others – and more recently, has been campaigning for wider access to COVID-19 vaccines and therapeutics. Fatima Hassan ‘The reason we brought the case was because we saw the ‘Lazarus’ drugs. We saw them working for people in the USA. We saw them working for people in Europe.,” said Hassan. “We saw what Brazilian and Thai activists were doing to try to get compulsory measures in place for their governments to introduce generic therapies into their country. But our government was having none of that. It was in denial of the science and it refused to implement a public sector programme, which is the reason why we had to focus on the price of abuse in the private sector.” Hassan says that today’s struggles include fighting for access to expensive cancer treatments, exorbitant cystic fibrosis drugs and cabotegravir, an HIV prevention injection that received regulatory approval for use in South Africa on Thursday but remains too expensive for most. “Pharmaceutical companies have these IP monopolies which then means that we’ve got to continuously fight them on pricing because, in the absence of our government, taking the necessary executive action or issuing compulsory licences, we’re always going to have to rely on civil society or the Competition Commission to deal with the abuse of dominance, capture of the market and excessive pricing,” said Hassan. Africa’s Progress Against Maternal and Infant Mortality Has ‘Flatlined’ 01/12/2022 Kerry Cullinan Millions of African women don’t have access to skilled birth attendants. In the past decade, Africa’s progress against maternal and infant mortality has flatlined, and it will need to reduce maternal deaths by a massive 86%, and more than halve the deaths of babies to reach global targets by 2030. This is according to the Atlas of African Health Statistics 2022 released by the World Health Organization’s (WHO) Africa region on Thursday. The atlas assessed the nine targets related to the Sustainable Development Goal (SDG) on health, and estimates that 390 women will die in childbirth for every 100 000 live births by 2030 in sub-Saharan Africa, based on the current rate of progress. This is over five times higher than the 2030 SDG target of fewer than 70 maternal deaths per 100 000 live births, and exponentially higher than the average of 13 deaths per 100 000 live births witnessed in Europe in 2017. The region’s infant mortality rate is 72 per 1000 live births, with a slow annual decline of 3.1%. At this rate, there will be 54 deaths per 1000 live births by 2030, more than double the target of fewer than 25 per 1000. WHO Africa official Dr Humphrey Karamagi described the slowdown in progress as “drastic”, with the likelihood of Africa reaching global targets being unlikely. A slowdown in the progress made during the past decade against maternal & infant mortality is projected in the #African 🌍 Region, a new WHO report released today finds ➡️ https://t.co/6W7eTEaANk pic.twitter.com/nOomg9jhRP — WHO African Region (@WHOAFRO) December 1, 2022 Incomplete abortions The main cause of maternal death is haemorrhaging, followed by sepsis, said Dr Benjamin Tsofa, Principal Research Officer at Kenya Medical Research Institute (KEMRI), who also addressed the briefing. Some of this bleeding was caused by “incomplete abortions” – abortion is illegal in most African countries – but Karamagi said that it was impossible to calculate what percentage this was. “There are different policies in different countries around safe abortion, and the pattern will differ really on a country-by-country basis,” said Karamagi. “What we do know is that the major cause of maternal deaths at present is bleeding, particularly during labour, [whether] it’s due to unsafe abortion or it’s due to lack of appropriate care and so on. I think it’s important that we unpack what is driving that in the different countries and address it.” Karamagi added that millions of women in the region did not have access to antenatal care – access ranged from 30-90% across countries – despite the evidence that it plays a major role in reducing maternal and neonatal mortality. Pandemic’s effect However, between 2000 and 2010, Africa made progress on a number of health issues: under-5 mortality fell by 35%, neonatal death rates dropped by 21%, and maternal mortality declined by 28%. Since then, however, “advances in all three targets have flatlined” – and more recently, the COVID-19 pandemic has undermined progress. “Crucial health services such as postnatal care for women and newborns, neonatal intensive care units, and antenatal care services, immunisation services were disrupted during the pandemic,” notes the report. “Since 2021, Africa has also faced a resurgence in vaccine-preventable disease outbreaks. Measles cases rose by 400% between January and March 2022 compared with the same period the year before.” Dr Matshidiso Moeti, WHO Regional Director for Africa., warned: “It is crucial that governments make a radical course correction, surmount the challenges and speed up the pace towards the health goals. These goals aren’t mere milestones, but the very foundations of healthier life and well-being for millions of people.” Image Credits: Elizabeth Poll/MMV. Air Pollution Linked to Nearly Half of all Stillbirths 01/12/2022 Stefan Anderson The new study is the latest addition to an ever-growing mountain of evidence documenting the negative effects of air pollutants on human health. In 2020, UNICEF estimated that “a stillbirth occurs every 16 seconds somewhere in the world.” A new study has linked air pollution to nearly half of them. The study of 137 countries is the first global analysis to assess the number of fetal deaths, putting into numbers the already documented link between fine particulate matter (PM2.5) concentrations and stillbirths. PM2.5 is primarily produced through the burning of fossil fuels. The United Nations estimates around two million stillbirths occur every year, and describes the global burden of stillbirths as a ‘neglected tragedy’. Some 98% of stillbirths are estimated to occur in low- and middle-income countries across Asia, Africa, and Latin America. Progress in combatting the crisis has stalled, and stillbirths continue to receive little attention on the global health agenda. Despite their impacts on millions around the world, stillbirths are not included in the Millennium Development Goals targets. “Current efforts to prevent stillbirth focus on medical service improvements but compared to clinical risk factors, environmental ones are usually unseen.” Dr Tao Xue, the first author of the study, told the Guardian. “Clean air policies, which have been enacted in some countries, such as China, can prevent stillbirths. In addition, personal protections against air pollution, i.e. wearing masks, installing air purifiers, and avoiding going outside when air pollution occurs could also protect vulnerable pregnant women.” A neglected tragedy The United Nations estimates 98% of all stillbirths occur in low-and middle-income countries. The study estimates cutting air pollution to the World Health Organization’s recommended limits could prevent 710,000 stillbirths a year, but the exact mechanisms behind how air pollution causes stillbirths are still unclear. The researchers found PM2.5 particles could be passing from the mother to the foetus through the placenta, which may not only harm the placenta but also potentially cause “irreversible embryonic damage.” A 2018 study found toxic pollutant particles in the lungs, livers and brains of foetuses. Further, PM2.5 exposure during pregnancy could also reduce oxygen transfer to the foetus or cause placental abnormalities – all possible causes of stillbirths. The study also stressed that the impacts of stillbirths stretch far beyond the strictly medical. Stillbirths have well-documented links to psychological conditions like anxiety, grief, and post-traumatic stress disorders, and the economic burdens resulting from healthcare costs and the inability to work affect individuals and their families – often driving sex inequalities as a consequence. Air pollution is a global epidemic Mounting scientific evidence on the adverse health effects of air pollution shows cutting PM2.5 concentrations would save the lives of millions. This latest study adds to a mounting pile of evidence on the harms of air pollution. It kills nearly seven million people every year, penetrates the brain and lungs of fetuses, is correlated with adverse birth outcomes like miscarriages, pre-mature birth and low birthweight, and is linked to adverse brain development in young children. In 2021, the World Health Organization slashed its limit on air pollution concentration in half, urging nations to tackle polluted air to save millions of lives. WHO estimates 99% of the global population now breathes air beyond its recommended limit. Earlier this year, the Lancet found air pollution is the world’s largest environmental risk factor for disease and premature death. While the exact number of stillbirths that could be prevented through meaningful reductions in air pollution is unknown, the study is the latest of a long series of scientific footnotes showing that slashing PM2.5 concentrations would improve the health of millions around the world – and the most vulnerable populations most of all. Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Twenty Years On, HIV Activist is Still Fighting for Access to Cheaper Medicine 01/12/2022 Kerry Cullinan HIV activist Hazel Tau Twenty years ago, Hazel Tau, a young South African living with HIV, and her peers had little chance of getting antiretroviral (ARV) treatment because it was completely unaffordable. The South African price for just one of the three ARV drugs she needed, AZT, was 665% higher than the best-priced generic available elsewhere in the world. Only around 20,000 South Africans with private healthcare were on ARVs at the time because of the price. So Tau, an activist with the Treatment Action Campaign, agreed to be one of the public faces of a challenge to the price of ARVs – cleverly brought as a complaint to the Competition Commission alleging that two pharmaceutical companies were charging excessive prices for first-line ARVs. At the time, then-president Thabo Mbeki disputed that HIV caused AIDS and claimed that ARVs were poison, so pressuring the government to act on drug prices was a non-starter. The targets were GlaxoSmithKline South Africa and Boehringer Ingelheim, with Tau and others complaining that they had contravened the country’s Competition Act by abusing their dominant market positions on ARV prices. The SA Competition Commission’s Mapato Ramakgopa explained that the commission agreed with Tau and others, and had sought an order from the competition tribunal to compel the firms to grant voluntary licences to allow generic manufacturers to make genetic ARVs in return for a reasonable royalty. “The firms were found to have abused market dominance and fortunately, before the case could be heard by the tribunal, the manufacturers settled the matter and agreed to allow licences for generic and local manufacturers,” said Ramakgopa. Bittersweet victory “It was a bittersweet experience because of everyone who could not be saved,” said Tau, speaking at a commemorative event on Thursday. “I lost friends, family, colleagues. We lost millions of people who were breadwinners. But I will say I was happy with the outcome.” Finally, she and others could look forward to a life with access to affordable treatment. But Tau’s struggle for treatment access continues today as she is fighting for cheaper cancer drugs. “We know that, in developed countries, they’ve got cheaper drugs that can help people who have got cancer of different types, but we still have to pay it so I’m not feeling good about that,” said Tau. She is also still fighting the stigma faced by people living with HIV – and says that it is time for stand-alone HIV clinics – largely the result of special HIV funding – to be integrated as part of chronic care to spare those who need HIV care from being conspicuous when they go for treatment. “I blame us for having that HIV clinic. I wish HIV was just dealt with like other chronic diseases, normally without saying ‘this is an HIV thing’ because the stigma started there,” says Tau. Speaking on World AIDS Day, Tau said that she honoured those who had passed on and those newly infected and wished that AIDS awareness campaigns were active every day. Access to affordable medicine Access to affordable medicine continues to haunt people from poorer countries, as the COVID-19 pandemic showed when millions of people in low and middle-income countries could not get vaccines as these had all been bought by wealthy countries. The question of intellectual property (IP) rights on essential medicine is as burning an issue today as it was during the AIDS era. Fatima Hassan, director of the Health Justice Initiative (HJI), was one of the lawyers representing Tau and others – and more recently, has been campaigning for wider access to COVID-19 vaccines and therapeutics. Fatima Hassan ‘The reason we brought the case was because we saw the ‘Lazarus’ drugs. We saw them working for people in the USA. We saw them working for people in Europe.,” said Hassan. “We saw what Brazilian and Thai activists were doing to try to get compulsory measures in place for their governments to introduce generic therapies into their country. But our government was having none of that. It was in denial of the science and it refused to implement a public sector programme, which is the reason why we had to focus on the price of abuse in the private sector.” Hassan says that today’s struggles include fighting for access to expensive cancer treatments, exorbitant cystic fibrosis drugs and cabotegravir, an HIV prevention injection that received regulatory approval for use in South Africa on Thursday but remains too expensive for most. “Pharmaceutical companies have these IP monopolies which then means that we’ve got to continuously fight them on pricing because, in the absence of our government, taking the necessary executive action or issuing compulsory licences, we’re always going to have to rely on civil society or the Competition Commission to deal with the abuse of dominance, capture of the market and excessive pricing,” said Hassan. Africa’s Progress Against Maternal and Infant Mortality Has ‘Flatlined’ 01/12/2022 Kerry Cullinan Millions of African women don’t have access to skilled birth attendants. In the past decade, Africa’s progress against maternal and infant mortality has flatlined, and it will need to reduce maternal deaths by a massive 86%, and more than halve the deaths of babies to reach global targets by 2030. This is according to the Atlas of African Health Statistics 2022 released by the World Health Organization’s (WHO) Africa region on Thursday. The atlas assessed the nine targets related to the Sustainable Development Goal (SDG) on health, and estimates that 390 women will die in childbirth for every 100 000 live births by 2030 in sub-Saharan Africa, based on the current rate of progress. This is over five times higher than the 2030 SDG target of fewer than 70 maternal deaths per 100 000 live births, and exponentially higher than the average of 13 deaths per 100 000 live births witnessed in Europe in 2017. The region’s infant mortality rate is 72 per 1000 live births, with a slow annual decline of 3.1%. At this rate, there will be 54 deaths per 1000 live births by 2030, more than double the target of fewer than 25 per 1000. WHO Africa official Dr Humphrey Karamagi described the slowdown in progress as “drastic”, with the likelihood of Africa reaching global targets being unlikely. A slowdown in the progress made during the past decade against maternal & infant mortality is projected in the #African 🌍 Region, a new WHO report released today finds ➡️ https://t.co/6W7eTEaANk pic.twitter.com/nOomg9jhRP — WHO African Region (@WHOAFRO) December 1, 2022 Incomplete abortions The main cause of maternal death is haemorrhaging, followed by sepsis, said Dr Benjamin Tsofa, Principal Research Officer at Kenya Medical Research Institute (KEMRI), who also addressed the briefing. Some of this bleeding was caused by “incomplete abortions” – abortion is illegal in most African countries – but Karamagi said that it was impossible to calculate what percentage this was. “There are different policies in different countries around safe abortion, and the pattern will differ really on a country-by-country basis,” said Karamagi. “What we do know is that the major cause of maternal deaths at present is bleeding, particularly during labour, [whether] it’s due to unsafe abortion or it’s due to lack of appropriate care and so on. I think it’s important that we unpack what is driving that in the different countries and address it.” Karamagi added that millions of women in the region did not have access to antenatal care – access ranged from 30-90% across countries – despite the evidence that it plays a major role in reducing maternal and neonatal mortality. Pandemic’s effect However, between 2000 and 2010, Africa made progress on a number of health issues: under-5 mortality fell by 35%, neonatal death rates dropped by 21%, and maternal mortality declined by 28%. Since then, however, “advances in all three targets have flatlined” – and more recently, the COVID-19 pandemic has undermined progress. “Crucial health services such as postnatal care for women and newborns, neonatal intensive care units, and antenatal care services, immunisation services were disrupted during the pandemic,” notes the report. “Since 2021, Africa has also faced a resurgence in vaccine-preventable disease outbreaks. Measles cases rose by 400% between January and March 2022 compared with the same period the year before.” Dr Matshidiso Moeti, WHO Regional Director for Africa., warned: “It is crucial that governments make a radical course correction, surmount the challenges and speed up the pace towards the health goals. These goals aren’t mere milestones, but the very foundations of healthier life and well-being for millions of people.” Image Credits: Elizabeth Poll/MMV. Air Pollution Linked to Nearly Half of all Stillbirths 01/12/2022 Stefan Anderson The new study is the latest addition to an ever-growing mountain of evidence documenting the negative effects of air pollutants on human health. In 2020, UNICEF estimated that “a stillbirth occurs every 16 seconds somewhere in the world.” A new study has linked air pollution to nearly half of them. The study of 137 countries is the first global analysis to assess the number of fetal deaths, putting into numbers the already documented link between fine particulate matter (PM2.5) concentrations and stillbirths. PM2.5 is primarily produced through the burning of fossil fuels. The United Nations estimates around two million stillbirths occur every year, and describes the global burden of stillbirths as a ‘neglected tragedy’. Some 98% of stillbirths are estimated to occur in low- and middle-income countries across Asia, Africa, and Latin America. Progress in combatting the crisis has stalled, and stillbirths continue to receive little attention on the global health agenda. Despite their impacts on millions around the world, stillbirths are not included in the Millennium Development Goals targets. “Current efforts to prevent stillbirth focus on medical service improvements but compared to clinical risk factors, environmental ones are usually unseen.” Dr Tao Xue, the first author of the study, told the Guardian. “Clean air policies, which have been enacted in some countries, such as China, can prevent stillbirths. In addition, personal protections against air pollution, i.e. wearing masks, installing air purifiers, and avoiding going outside when air pollution occurs could also protect vulnerable pregnant women.” A neglected tragedy The United Nations estimates 98% of all stillbirths occur in low-and middle-income countries. The study estimates cutting air pollution to the World Health Organization’s recommended limits could prevent 710,000 stillbirths a year, but the exact mechanisms behind how air pollution causes stillbirths are still unclear. The researchers found PM2.5 particles could be passing from the mother to the foetus through the placenta, which may not only harm the placenta but also potentially cause “irreversible embryonic damage.” A 2018 study found toxic pollutant particles in the lungs, livers and brains of foetuses. Further, PM2.5 exposure during pregnancy could also reduce oxygen transfer to the foetus or cause placental abnormalities – all possible causes of stillbirths. The study also stressed that the impacts of stillbirths stretch far beyond the strictly medical. Stillbirths have well-documented links to psychological conditions like anxiety, grief, and post-traumatic stress disorders, and the economic burdens resulting from healthcare costs and the inability to work affect individuals and their families – often driving sex inequalities as a consequence. Air pollution is a global epidemic Mounting scientific evidence on the adverse health effects of air pollution shows cutting PM2.5 concentrations would save the lives of millions. This latest study adds to a mounting pile of evidence on the harms of air pollution. It kills nearly seven million people every year, penetrates the brain and lungs of fetuses, is correlated with adverse birth outcomes like miscarriages, pre-mature birth and low birthweight, and is linked to adverse brain development in young children. In 2021, the World Health Organization slashed its limit on air pollution concentration in half, urging nations to tackle polluted air to save millions of lives. WHO estimates 99% of the global population now breathes air beyond its recommended limit. Earlier this year, the Lancet found air pollution is the world’s largest environmental risk factor for disease and premature death. While the exact number of stillbirths that could be prevented through meaningful reductions in air pollution is unknown, the study is the latest of a long series of scientific footnotes showing that slashing PM2.5 concentrations would improve the health of millions around the world – and the most vulnerable populations most of all. Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Africa’s Progress Against Maternal and Infant Mortality Has ‘Flatlined’ 01/12/2022 Kerry Cullinan Millions of African women don’t have access to skilled birth attendants. In the past decade, Africa’s progress against maternal and infant mortality has flatlined, and it will need to reduce maternal deaths by a massive 86%, and more than halve the deaths of babies to reach global targets by 2030. This is according to the Atlas of African Health Statistics 2022 released by the World Health Organization’s (WHO) Africa region on Thursday. The atlas assessed the nine targets related to the Sustainable Development Goal (SDG) on health, and estimates that 390 women will die in childbirth for every 100 000 live births by 2030 in sub-Saharan Africa, based on the current rate of progress. This is over five times higher than the 2030 SDG target of fewer than 70 maternal deaths per 100 000 live births, and exponentially higher than the average of 13 deaths per 100 000 live births witnessed in Europe in 2017. The region’s infant mortality rate is 72 per 1000 live births, with a slow annual decline of 3.1%. At this rate, there will be 54 deaths per 1000 live births by 2030, more than double the target of fewer than 25 per 1000. WHO Africa official Dr Humphrey Karamagi described the slowdown in progress as “drastic”, with the likelihood of Africa reaching global targets being unlikely. A slowdown in the progress made during the past decade against maternal & infant mortality is projected in the #African 🌍 Region, a new WHO report released today finds ➡️ https://t.co/6W7eTEaANk pic.twitter.com/nOomg9jhRP — WHO African Region (@WHOAFRO) December 1, 2022 Incomplete abortions The main cause of maternal death is haemorrhaging, followed by sepsis, said Dr Benjamin Tsofa, Principal Research Officer at Kenya Medical Research Institute (KEMRI), who also addressed the briefing. Some of this bleeding was caused by “incomplete abortions” – abortion is illegal in most African countries – but Karamagi said that it was impossible to calculate what percentage this was. “There are different policies in different countries around safe abortion, and the pattern will differ really on a country-by-country basis,” said Karamagi. “What we do know is that the major cause of maternal deaths at present is bleeding, particularly during labour, [whether] it’s due to unsafe abortion or it’s due to lack of appropriate care and so on. I think it’s important that we unpack what is driving that in the different countries and address it.” Karamagi added that millions of women in the region did not have access to antenatal care – access ranged from 30-90% across countries – despite the evidence that it plays a major role in reducing maternal and neonatal mortality. Pandemic’s effect However, between 2000 and 2010, Africa made progress on a number of health issues: under-5 mortality fell by 35%, neonatal death rates dropped by 21%, and maternal mortality declined by 28%. Since then, however, “advances in all three targets have flatlined” – and more recently, the COVID-19 pandemic has undermined progress. “Crucial health services such as postnatal care for women and newborns, neonatal intensive care units, and antenatal care services, immunisation services were disrupted during the pandemic,” notes the report. “Since 2021, Africa has also faced a resurgence in vaccine-preventable disease outbreaks. Measles cases rose by 400% between January and March 2022 compared with the same period the year before.” Dr Matshidiso Moeti, WHO Regional Director for Africa., warned: “It is crucial that governments make a radical course correction, surmount the challenges and speed up the pace towards the health goals. These goals aren’t mere milestones, but the very foundations of healthier life and well-being for millions of people.” Image Credits: Elizabeth Poll/MMV. Air Pollution Linked to Nearly Half of all Stillbirths 01/12/2022 Stefan Anderson The new study is the latest addition to an ever-growing mountain of evidence documenting the negative effects of air pollutants on human health. In 2020, UNICEF estimated that “a stillbirth occurs every 16 seconds somewhere in the world.” A new study has linked air pollution to nearly half of them. The study of 137 countries is the first global analysis to assess the number of fetal deaths, putting into numbers the already documented link between fine particulate matter (PM2.5) concentrations and stillbirths. PM2.5 is primarily produced through the burning of fossil fuels. The United Nations estimates around two million stillbirths occur every year, and describes the global burden of stillbirths as a ‘neglected tragedy’. Some 98% of stillbirths are estimated to occur in low- and middle-income countries across Asia, Africa, and Latin America. Progress in combatting the crisis has stalled, and stillbirths continue to receive little attention on the global health agenda. Despite their impacts on millions around the world, stillbirths are not included in the Millennium Development Goals targets. “Current efforts to prevent stillbirth focus on medical service improvements but compared to clinical risk factors, environmental ones are usually unseen.” Dr Tao Xue, the first author of the study, told the Guardian. “Clean air policies, which have been enacted in some countries, such as China, can prevent stillbirths. In addition, personal protections against air pollution, i.e. wearing masks, installing air purifiers, and avoiding going outside when air pollution occurs could also protect vulnerable pregnant women.” A neglected tragedy The United Nations estimates 98% of all stillbirths occur in low-and middle-income countries. The study estimates cutting air pollution to the World Health Organization’s recommended limits could prevent 710,000 stillbirths a year, but the exact mechanisms behind how air pollution causes stillbirths are still unclear. The researchers found PM2.5 particles could be passing from the mother to the foetus through the placenta, which may not only harm the placenta but also potentially cause “irreversible embryonic damage.” A 2018 study found toxic pollutant particles in the lungs, livers and brains of foetuses. Further, PM2.5 exposure during pregnancy could also reduce oxygen transfer to the foetus or cause placental abnormalities – all possible causes of stillbirths. The study also stressed that the impacts of stillbirths stretch far beyond the strictly medical. Stillbirths have well-documented links to psychological conditions like anxiety, grief, and post-traumatic stress disorders, and the economic burdens resulting from healthcare costs and the inability to work affect individuals and their families – often driving sex inequalities as a consequence. Air pollution is a global epidemic Mounting scientific evidence on the adverse health effects of air pollution shows cutting PM2.5 concentrations would save the lives of millions. This latest study adds to a mounting pile of evidence on the harms of air pollution. It kills nearly seven million people every year, penetrates the brain and lungs of fetuses, is correlated with adverse birth outcomes like miscarriages, pre-mature birth and low birthweight, and is linked to adverse brain development in young children. In 2021, the World Health Organization slashed its limit on air pollution concentration in half, urging nations to tackle polluted air to save millions of lives. WHO estimates 99% of the global population now breathes air beyond its recommended limit. Earlier this year, the Lancet found air pollution is the world’s largest environmental risk factor for disease and premature death. While the exact number of stillbirths that could be prevented through meaningful reductions in air pollution is unknown, the study is the latest of a long series of scientific footnotes showing that slashing PM2.5 concentrations would improve the health of millions around the world – and the most vulnerable populations most of all. Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Air Pollution Linked to Nearly Half of all Stillbirths 01/12/2022 Stefan Anderson The new study is the latest addition to an ever-growing mountain of evidence documenting the negative effects of air pollutants on human health. In 2020, UNICEF estimated that “a stillbirth occurs every 16 seconds somewhere in the world.” A new study has linked air pollution to nearly half of them. The study of 137 countries is the first global analysis to assess the number of fetal deaths, putting into numbers the already documented link between fine particulate matter (PM2.5) concentrations and stillbirths. PM2.5 is primarily produced through the burning of fossil fuels. The United Nations estimates around two million stillbirths occur every year, and describes the global burden of stillbirths as a ‘neglected tragedy’. Some 98% of stillbirths are estimated to occur in low- and middle-income countries across Asia, Africa, and Latin America. Progress in combatting the crisis has stalled, and stillbirths continue to receive little attention on the global health agenda. Despite their impacts on millions around the world, stillbirths are not included in the Millennium Development Goals targets. “Current efforts to prevent stillbirth focus on medical service improvements but compared to clinical risk factors, environmental ones are usually unseen.” Dr Tao Xue, the first author of the study, told the Guardian. “Clean air policies, which have been enacted in some countries, such as China, can prevent stillbirths. In addition, personal protections against air pollution, i.e. wearing masks, installing air purifiers, and avoiding going outside when air pollution occurs could also protect vulnerable pregnant women.” A neglected tragedy The United Nations estimates 98% of all stillbirths occur in low-and middle-income countries. The study estimates cutting air pollution to the World Health Organization’s recommended limits could prevent 710,000 stillbirths a year, but the exact mechanisms behind how air pollution causes stillbirths are still unclear. The researchers found PM2.5 particles could be passing from the mother to the foetus through the placenta, which may not only harm the placenta but also potentially cause “irreversible embryonic damage.” A 2018 study found toxic pollutant particles in the lungs, livers and brains of foetuses. Further, PM2.5 exposure during pregnancy could also reduce oxygen transfer to the foetus or cause placental abnormalities – all possible causes of stillbirths. The study also stressed that the impacts of stillbirths stretch far beyond the strictly medical. Stillbirths have well-documented links to psychological conditions like anxiety, grief, and post-traumatic stress disorders, and the economic burdens resulting from healthcare costs and the inability to work affect individuals and their families – often driving sex inequalities as a consequence. Air pollution is a global epidemic Mounting scientific evidence on the adverse health effects of air pollution shows cutting PM2.5 concentrations would save the lives of millions. This latest study adds to a mounting pile of evidence on the harms of air pollution. It kills nearly seven million people every year, penetrates the brain and lungs of fetuses, is correlated with adverse birth outcomes like miscarriages, pre-mature birth and low birthweight, and is linked to adverse brain development in young children. In 2021, the World Health Organization slashed its limit on air pollution concentration in half, urging nations to tackle polluted air to save millions of lives. WHO estimates 99% of the global population now breathes air beyond its recommended limit. Earlier this year, the Lancet found air pollution is the world’s largest environmental risk factor for disease and premature death. While the exact number of stillbirths that could be prevented through meaningful reductions in air pollution is unknown, the study is the latest of a long series of scientific footnotes showing that slashing PM2.5 concentrations would improve the health of millions around the world – and the most vulnerable populations most of all. Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Alzheimer’s Drug is Hailed Amid Safety Concerns 01/12/2022 Kerry Cullinan Alzheimer’s disease is the most common type of dementia found in elderly people. A candidate drug for people with early Alzheimer’s disease slowed cognitive decline by about 27% over 18 months, according to a report on a phase 3 trial published in the New England Journal of Medicine on Tuesday. Lecanemab is a monoclonal antibody that is given as an intravenous infusion every two weeks, and targets a sticky protein, beta-amyloid, that clogs up the neural passageways of the brains of people with Alzheimer’s. A total of 1795 participants were enrolled in the phase 3 trial, with 898 receiving lecanemab and 897 receiving a placebo. “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” according to the report. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” The adverse events reported are “infusion-related reactions in 26.4% of the participants” as well as “amyloid-related imaging abnormalities with edema or effusions in 12.6%”. However, there were also some potentially serious side effects, with Science reporting that there have been two deaths possibly associated with the trial. A 65-year-old woman who was part of the trial died after a brain haemorrhage. She had amyloid deposits surrounding many of her brain’s blood vessels, this “likely contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels”, according to Science. Her death follows a report that an 80-year-old man who was part of the trial died from bleeding on the brain. Last year, the US Food and Drug Administration approved another Alzheimer’s drug also based on monoclonal antibodies called Aduhelm, although it has significant safety risks. Dementia is currently the seventh leading cause of death among all diseases and one of the major causes of disability and dependency among older people worldwide, according to the World. Some 60% of dementia cases are caused by Alzheimer’s disease. In May 2017, the World Health Assembly endorsed the Global action plan on the public health response to dementia 2017-2025. Image Credits: Photo by Steven HWG on Unsplash. South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment 01/12/2022 Megha Kaveri South Korea becomes an ML4-designated country for medicines and vaccines regulations. South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. Congratulations to Ministry of Food and Drug Safety @TheMFDS, Republic of Korea🇰🇷, to have achieved maturity level 4, the highest level in WHO’s classification of regulatory authorities for medical products https://t.co/DZojajQ04K pic.twitter.com/GSOphz770Q — World Health Organization (WHO) (@WHO) November 29, 2022 “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. Global Benchmarking Tool – WHO Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization. Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Samuel Kumwanje, Advocating for NCD Patients in Malawi 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Samuel Kumwanje When Samuel Kumwanje was diagnosed with a kidney disorder in 2004, his home country Malawi had only one dialysis unit located in the capital Lilongwe, about 330 km from the city of Balaka where he lived. “This is the time I learned that affordability of dialysis services is limited for Malawians,” Samuel writes in the NCD Diaries project, an initiative launched by the NCD Alliance. NCDs (short for noncommunicable diseases) are diseases that are not transmissible from person to person. They are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. NCDs are also a sustainable development issue. They have a disproportionate impact on people living in low- and middle-income countries and are both a cause and a consequence of poverty. NCD Alliance leads and coordinates global advocacy efforts to maintain political momentum and action, and sustain focus on NCDs. Born in 1976 in rural Malawi, Samuel started to suffer from problematic symptoms when he was 12. The symptoms included body pain, loss of appetite and vomiting, yet no one could understand the cause. “A district hospital referred me for a checkup at a public hospital (at which services are provided free of charge), and my results were sent to the UK for further investigation,” he recalls. “However, no diagnosis was made because tests related to kidney performance were not conducted – an indication of lack of focus on kidney disorder in our health system.” As a result, Samuel’s symptoms worsened. “Without a diagnosis, I turned to herbals from the local communities that my father sourced,” he says. “I believe that these herbs may have worsened rather than solved my kidney condition.” For years, the man continued to be misdiagnosed and prescribed the wrong treatments. “Finally at NGO-run Likuni Mission Hospital, they diagnosed me with kidney failure because one of my sisters-in-law, who is a nurse, advised me to request a check of my kidney performance,” he remarks. “This was a private service covered by my Medical Aid Society of Malawi medical insurance, made available through my employer.” Afterward, Samuel started to commute for dialysis. At that point, the Kamuzu Central Hospital, a government-run hospital in Lilongwe, only had four machines. As the number of patients in need of dialysis in Malawi increased, accessibility to treatment became an issue. At that point Samuel and other patients decided to take action. “We formed the Kidney Foundation – Malawi, an association to amplify the needs of people in the dialysis unit,” he says. “Among several objectives guiding the association, advocating with the Malawi Ministry of Health to prioritize renal conditions was one.” While things for patients with chronic kidney conditions in Malawi have improved, there is still much work to be done. Currently, there are only two public hospitals in the country that offer free dialysis services, with few machines for many patients. Malawi has a population of about twenty million people. “It’s not easy to live with kidney disorder when you are the breadwinner of the family, and it’s challenging when you are employed because you need to satisfy your boss while at the same time adhering to dialysis sessions,” Samuel says. “My goal is to shed light on the challenges that myself and people living with NCDs in Malawi face when it comes to affording care, in the hope for positive change around Universal Health Coverage.” Read Samuel Kumwanje full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
Betsy Rodriguez: Giving a Voice to those Who Live with Chronic Conditions 01/12/2022 Editorial team A special project celebrating the fifth anniversary of “Our Views, Our Voices” | Learn more Dr. Hedwig Borges as he goes through his journey with cutaneous T-cell lymphoma. For many years, Betsy Rodriguez was terrified that she could lose her daughter Carmen to hypoglycemia at any moment. As a girl, Carmen was diagnosed as having type 1 diabetes. “I cannot count the hours I’ve spent dealing with insurance companies and third-party vendor pharmacies for my daughter to receive a life-saving continuous glucose monitor and an insulin pump,” Betsy writes in the NCD Diaries project, an initiative launched by the NCD Alliance. “Now that she has these, my fear of losing her to hypoglycemia has settled!” Diabetes is one of the most common forms of NCDs – short for noncommunicable diseases, which are diseases that are not transmissible from person to person. Continuous glucose monitor (CGM) and continuous subcutaneous insulin infusion (CSII). NCDs are the first cause of death and disability worldwide, accounting for 74% of all deaths and more than three out of four years lived with a disability. They also include cancers, cardiovascular disease, stroke, chronic respiratory diseases, mental health and neurological conditions, amongst many others. The NCD Diaries are a participatory, community-based and multimedia storytelling project that illustrates and highlights individual lived experiences and calls for action on NCDs. Because of Carmen’s condition, Betsy had always been aware of the challenges of taking care of a person with a chronic disease. However, this did not prepare her for the moment her husband Hedwig, also known as Papa Bear, was diagnosed with cancer five years ago. “Hearing the word ‘cancer’ in a diagnosis is terrifying enough, but here’s another scary thought: the treatment method is likely to be dictated by your insurance coverage,” she wrote. “It was devastating to see the love of my life and husband of 46 years go through his journey with Cutaneous T-cell lymphoma – a rare cancer.” Hedwig and his whole family were heavily affected by the disease and the treatments he had to undergo. “His appearance, vitality and productivity altered, so I became the caregiver and only source of income,” Brenda says. “Catastrophic conditions like these demand high out-of-pocket payments. Sometimes, I feel like a deflated balloon!” For her, taking part in the NCD Diaries was very important. “I want to give a voice to those that live with chronic conditions that do not have a voice, especially those from marginalized communities living and experiencing health disparities and inequities,” Brenda emphasizes. “I want to help put a face to diabetes and other chronic conditions.” Read Betsy Rodriguez’s full NCD Diary. Read previous post. Image Credits: Courtesy of NCD Alliance. Posts navigation Older postsNewer posts