Cancer
Dr Tlotlo Ralefala, on oncologist at Princess Marina Hospital in Botswana, examines a patient.

Successful intervention is urgently needed – and entirely possible. 

Cancer kills nearly 10 million people a year, but the risk of dying from cancer varies greatly depending on where in the world you live. About 70%  of these deaths are in low- and middle-income countries – and the disparity is worsening.

A Lancet Oncology Commission report, published in May 2022, highlights that, in Africa, cancer deaths are expected to more than double, reaching roughly 1.4 million deaths annually by 2040. Meanwhile, in the U.S., the latest American Cancer Society statistics point to a 28-year, 32% decline in cancer deaths.

With President Joe Biden’s reignited Cancer Moonshot initiative, the US is doubling down on its commitment to save lives. The initiative aims to reduce the cancer death rate by at least 50% over the next 25 years. 

Although the immediate goals are domestic, the ambitions of the Cancer Moonshot extend globally, recognizing the disparities in death rates and the value of international collaborations. During the US-Africa Leaders Summit in December, the White House announced $200 million in new and renewed commitments to fighting cancer in Africa.

This is a step in the right direction, but far more is urgently needed. This week, the World Health Organization’s Executive Board reviewed and approved updated recommendations on “best buys” for noncommunicable diseases, with cancer high on the list. This, and World Cancer Day, observed today, 4 February, makes it a good time to turn our focus to the rapidly escalating crisis of cancer in Africa and what must be done about it.

Sub-Saharan Africa particularly alarming

Deaths from cervical cancer by age in 2018

In the region of sub-Saharan Africa, the situation is particularly alarming. The Lancet Commission found the cancer incidence rate to be higher there than in other world regions of comparable social and economic development, as measured by the Human Development Index (HDI).

Compared with people in the world’s most developed regions (identified as “very high HDI regions” in the report), the Lancet commission found that people in sub-Saharan Africa seem to face a lower risk of getting cancer but a much higher risk of dying from it. The mortality-to-incidence ratios were seven in 10 for sub-Saharan Africa and three in 10 for very high HDI regions.

How do we explain this?

First, there are crucial differences in detection, diagnosis and treatment. Wealthy countries have many resources at their disposal; sub-Saharan African countries don’t. Shortages are widespread: not enough healthcare providers trained in oncology, inadequate diagnostic equipment and limited access to treatments such as radiotherapy and chemotherapy are among the barriers. This means that cancer takes a long time to be diagnosed, let alone treated. Many patients die, needlessly, from cancers that have high survival rates in wealthy, well-equipped regions of the world.

Second, it is likely that cancer cases are vastly underreported in sub-Saharan Africa, where population-based cancer registries – the gold standard of information on cancer incidence in a population – are scarce. Also, cancer is underdiagnosed in sub-Saharan Africa, partly because of severely limited diagnostic capacity and societal barriers in seeking health care.

Highest rates of cervical cancer in the world

Cervical cancer awareness

Even with limited data, sub-Saharan Africa has the highest rates of cervical cancer in the world, and cervical cancer is the leading cause of cancer deaths in the region, followed by breast cancer. In sub-Saharan African men, prostate cancer leads in both incidence and mortality. There are various reasons why these kinds of cancers are common in sub-Saharan Africa, including rising rates of obesity, higher rates of HIV infection, and genetics. While these root causes have no simple solutions, all three cancer types have highly effective preventive care and early detection protocols that, if implemented, would save many lives.

We live in a world that has made remarkable scientific and medical advancements in cancer detection, diagnosis and treatment, but a person’s chances of surviving cancer hinge arbitrarily on where they were born. This is unacceptable.

The Lancet Commission, in its May 2022 report, recommended several urgent actions. Among them are: the creation of early detection and prevention programmes; building and supporting national cancer registries, establishing workforce training, raising community awareness and – a lesson from covid – investing in telehealth.

Begin in one country and prove change is possible

Botswana-Rutgers Partnership for Health; begin in one country and prove change is possible.

If the prospect of introducing changes in so many areas throughout sub-Saharan Africa seems insurmountable, begin in one country and prove change is possible there. This is the aim of the Botswana-Rutgers Partnership for Health, through which Rutgers University and Rutgers Health are collaborating with Botswana’s government to implement needed cancer care and prevention strategies.

Recently, the partnership launched Cancer Kitso, an education and training initiative that responds to urgent specialty workforce needs in oncology. Using both on-site and virtual training components, Cancer Kitso aims to improve cancer care and prevention knowledge and skills among healthcare professionals in Botswana. 

To close the breast cancer screening gap, the partnership also is piloting a rapid “screen and treat” clinical approach for early breast cancer detection and treatment. This effort includes evaluating evidence-based interventions in primary care clinics, as well as training nurses to administer clinical breast examinations and to provide breast self-care education to women.

Universities, companies and philanthropies all can take more active roles in collaborating with African governments to confront cancer. Hearts, minds and funding will follow – at a level that could move mountains.

Precedent exists: In the late 1990’s and early 2000s, the sub-Saharan African country of Botswana faced the most severe HIV epidemic in the world. Botswana’s government partnered with outside universities, pharmaceutical companies and private foundations to launch an aggressive and highly successful national HIV/AIDS prevention, treatment and care initiative. Based largely on Botswana’s success, President George W. Bush in 2003 allocated billions of dollars to establish a global HIV/AIDS response that has gone on to save more than 25 million lives in many countries worldwide.

HIV/AIDS once seemed like too big a problem to fight in Africa, and no one believed it would work – until it did, and attitudes and priorities changed.

Cancer is threatening sub-Saharan African populations to a degree that demands a large-scale response. There are many interventions that we know will work and we have no time to wait. Millions of lives hang in the balance. 

____________________________________________________

Wilfred Ngwa is a professor of global health at Rutgers Global Health Institute and chair of the Lancet Oncology Commission for sub-Saharan Africa.
Richard Marlink is the director of Rutgers Global Health Institute and one of the creators of the Botswana-Rutgers Partnership for Health.

Image Credits: The Lancet, Shutterstock , Rutgers University.

Nutrition
Diets rich in fresh fruits and vegetables combat obesity – but these are being overtaken by fast and processed foods in developing as well as developed countries. Portrayed here a market in Tamil Nadu, India

A new report on global nutrition from the head of the World Health Organization (WHO) reveals just how much the COVID-19 pandemic hurt the world’s efforts to improve healthy eating and reduce diet-related noncommunicable diseases.

Despite declaring 2016-2025 as the “United Nations Decade of Action on Nutrition,” the UN General Assembly’s efforts to bolster nutrition within the 17 Sustainable Development Goals by 2030 have largely been crushed by the devastating impacts of the pandemic.

The nutrition goals, in line with World Health Assembly resolutions from a decade ago, target issues such as child wasting, stunting and being overweight; anaemia in women aged 15 to 49; low birth weight; the rise in diabetes and obesity; and excessive intake of salt/sodium.

“The effects of the COVID-19 pandemic, other health emergencies – together with the disruption of the food supply caused by intensified conflicts and climate change – impede progress towards ending hunger and malnutrition in all its forms and achieving the health-related targets of the Sustainable Development Goals,” according to the report from WHO Director-General Dr Tedros Adhanom Ghebreyesus, which was approved by the body’s Executive Board (EB) on Friday.

“Adult obesity continues to rise worldwide. More than 1.9 billion adults are affected by overweight or obesity,” the report notes. “Nearly 3.1 billion people could not afford a healthy diet in 2020. At the same time, up to 222 million people in 53 countries or territories are expected to face acute food insecurity or worse conditions, with malnutrition remaining at critical levels.”

Yet the report also notes that “in the face of existing setbacks, there is very positive momentum and urgency for accelerated efforts towards the global nutrition targets.”

Nutrition
Between 1975 and 2016, southern Africa saw the world’s highest proportional increase in child and adolescent #obesity – an alarming 400% per decade. Ultra-processed foods and sugary drinks contribute to rising rates of #diet-related diseases.

Acute need to improve nutrition in Africa

Globally, some 193 million experienced a food crisis in 2021, up from 155 million people a year earlier, according to the Global Report on Food Crises 2022.

Among the 10 countries with the most people in crisis, more than half were in Africa: the Democratic Republic of the Congo, Ethiopia, Yemen, Nigeria, Sudan and South Sudan. The others were Afghanistan, Syria, Pakistan and Haiti.

Unsurprisingly, the African Union (AU) declared last year as the Year of Nutrition in the face of widespread hunger from COVID-19, conflict and climate change.

And last June, WHO announced it was setting up a hub in Kenya to help fight the “major physical and mental health repercussions” of the food crisis in the Eastern Africa region.

“Malnutrition remained at critical levels in countries affected by food crises, driven by a complex interplay of factors, including low quality food due to acute food insecurity and poor child-feeding practices, a high prevalence of childhood illnesses, and poor access to sanitation, drinking water and health care,” the World Food Program’s report says.

Despite limited data, the report shows almost 26 million children under 5 years old were suffering from wasting and in need of urgent treatment in 23 of the 35 major food crises and more than 5 million children were at an increased risk of death due to severe wasting.

In the 10 countries with the highest number of people in crisis, 17.5 million children were wasted – a term that refers to when a child is too thin for his or her height and results from recent rapid weight loss or the failure to gain weight.

Friction over corporate nutrition

Before the report’s passage, Tedros said he had “two prayers” for the world –  one for more food on the table for everyone, the other for less unhealthy food.

“So the issue now is addressing both both obesity and malnutrition. And I think the key is to implement the action plan in its totality,” he told the EB, adding that another important issue is the UN healthy agency’s carrot-and-stick approach to corporate engagement on nutrition.

“I would like to assure you that we collaborate on issues we can collaborate. On issues we can’t and we don’t, then we continue the dialogue, but we use the regulatory function to enforce,” said Tedros. “WHO has not been working with the food industry. It’s mainly – to us – confrontational. I don’t think that approach really helps.”

Tedros said WHO can enforce regulations when needed, but he obviously prefers to gain corporate cooperation whenever possible, which is what happened in 2019 when the food industry agreed to eliminate industrial trans fats by 2023.

“Many of them are doing it already. So we collaborate on that. While on salt and sugar, we still have a problem and on breastfeeding we have a problem,” he added.

Nutrition
The UN Decade of Action on Nutrition, Explained

Image Credits: @veerajayanth03, Dr Alexey Kulikov/Twitter, United Nations.

WHO independent evaluation
The Executive Board considers a new initiative on falsified and substandard medical products.

World Health Organization’s Executive Board (EB) has gotten behind the rollout of an independent evaluation of the agency’s member state mechanism addressing  falsified and substandard medical products in order to see how surveillance and enforcement of production standards could be improved. 

The initiative, which now needs to go to the World Health Assembly in May, follows in the wake of a raft of recent reports on  illnesses and deaths from contaminated medicines – that have been implicated in the deaths of dozens of children in Asia and Africa. 

Those include high-profile reports of the recent deaths of at least 66 children in The Gambia and 18 children in Uzbekistan, all linked to consumption of tainted cough syrups produced in India.   

In the EB discussion on Thursday, countries also asked WHO to facilitate the more effective sharing of information on fake and substandard medicines and the necessary expertise to address the problem. 

However, member states like Brazil and Thailand, as well as  several  civil society  actors,  also stressed that tightening regulations around medicines manufacture should not be designed in a way that exacerbates already existing shortages and restrictions in medicines access in low- and middle-income countries. 

“The evaluation should include recommendations aimed at addressing the lack of equitable access to medicines, high drug pricing, supply and demand issues, and regulatory failures, which enable the circulation of quality-compromised medicine,”  said Medicus Mundi International and the People’s Health Movement in a statement to the EB.

Other countries, such as Colombia, stressed that their national authorities are just now setting up a medicines surveillance system to regulate drugs. So reports of the presence of tainted or fake medicines problems doesn’t necessarily mean that overall standards are low – but that enforcement is weak. . 

“Many countries are only just starting to implement their certification systems, and therefore if they have problems that doesn’t necessarily mean they have low standards that facilitate the proliferation of substandard and falsified medical products. It just means that they’re at an early stage of developing systems to cope with it,” Colombia’s delegate, Sr. Jaime Hernán Urrego Rodríguez, Vice Minister of Public Health, pointed out. 

WHO EB
Sr. Jaime Hernán Urrego Rodríguez, the vice-minister for public health, Colombia.

Sharing is caring

Several member states also called on the WHO to facilitate more sharing of information and the development of technical expertise to detect and take timely action on fake and substandard medicines. 

“When we have substandard or falsified medical products, we’re talking about an issue that varies considerably from one country to another depending on the regulatory authorities capacity to act in different countries and depending on the environment in which it finds itself,” the EB delegate from Senegal stated, on behalf of 47 member states from Africa. 

“We therefore would encourage the Secretariat to facilitate the exchange of information, the sharing and pooling of information among states, and also between the global network, with the focal points and other mechanisms and platforms that may exist.” 

Contaminated cough syrups responsible for at dozens of deaths

Contaminated cough syrups have been implicated in the reported deaths of hundreds of deaths of children in Asia and Africa over the past decade, including dozens of children in the past year. 

At the EB session, delegates from the USA and Botswana highlighted the severity of the fake drugs problem, as evidenced by the proliferation of recent incidents, calling for coordinated action to “address this critical and preventable issue”. 

On January 25, the US Food and Drug Administration (FDA) announced that it will join hands with the WHO and other organizations in a joint investigation into the source of these contaminated cough syrups. 

In October 2022, the WHO issued a product alert concerning four cough syrup products, contaminated with diethylene glycol (DEG) and ethylene glycol (EG).

“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the alert pointed out. The samples were tested in laboratories in Switzerland and Ghana. 

WHO added that the manufacturer of all the four syrups was an Indian company, Maiden Pharmaceuticals Private Limited. These cough syrups were sold in the Gambia. At least 66 children died after consuming the tainted cough syrups, WHO stated, although an investigation into the precise cause of deaths is still going on. 

While India said it found no manufacturing malfunction at Maiden Pharmaceuticals, the WHO has not retracted its report.

Cough syrup
The products from Maiden Pharmaceuticals, flagged by the WHO, after tests in both Switzerland and Ghana showed evidence of chemical contamination.

The WHO also flagged another Indian pharmaceutical manufacturer, Marion Biotech Private Limited, for exporting substandard products laced with DEG and EG to Uzbekistan in central Asia. In a product alert issued in January 2023, the agency said, “Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.” Use of these products has been linked to the recent deaths of 19 children in Uzbekistan. 

India, the EB member whose manufacturers have been the focus of many of the complaints, did not present a statement at Thursday’s session. 

Don’t set manufacturing standards so high that they impede access

Brazil and Thailand called for the WHO to ensure that the work to advance safe medicines does not inadvertedly impact access to medicines, by setting the bar too high for the production of medicines by low- and middle-income countries.  

“Brazil supports initiatives that promote access to affordable, safe, and quality medical products, including through actions aiming at preventing detecting and responding to substandard and falsified medical products. Actions in this area nevertheless should not hamper the critical work to enable access to medicines through the provision of generic drugs,” Brazil said. 

“The requirement to meet manufacturing standards should not become a barrier to access or an excuse to protect the interest of patent holding producers,” added Medicus Mundi International and the People’s Health Movement in their EB statement. 

There is a risk that raising manufacturing standards too high – to the levels of the United States or European regulators could boomerang, impinging on the production of generic  medicines in Africa and Asia, explained civil society actors at an EB side event on Tuesday evening, sponsored by Knowledge Ecology International. 

Rather, WHO Good Manufacturing Practices (GMP), and low- and middle income countries, such as Morocco, with a good track record of implementing good quality control standards, should be considered as models for emulation, they argued. The WHO GMP is used as the basis for WHO’s Prequalification scheme for medicines and vaccines that are approved by the global health agency for procurement by other UN and UN-Supported agencies.

Image Credits: Megha Kaveri, World Health Organization.

Noma
Umar, an eight-year-old noma patient from Kano Sstate, Nigeria, and Adamu, a 15-year-old noma patient from Kebbi State, stand at the entrance of the post-operative ward at the Sokoto Noma Hospital. The two boys are looking forward to going outside.

Twenty years ago, 16-year-old Mulikat Okanlawan embarked on a 1000-kilometer journey from her home in the Nigerian capital of Lagos to the Northwestern city of Sokoto in a bid to change her life.

She is a survivor of noma, a little-known bacterial disease that attacks cells in facial tissue and bones. On paper, Okanlawan had been lucky. Noma is fatal in 90% of cases, often taking the life of those infected within mere days.

Mulikat, a 33-year-old former patient originally from the south of Nigeria, moved to Sokoto 17 years ago to undergo facial reconstructive surgery. She now works in the hospital.

But survivors, mostly children between the ages of 2 and 6 at the time of infection, are left with severe facial deformities that follow them long after the acute phase of noma subsides. These can make it hard to eat, speak, see or breathe, and often lead to discrimination against survivors in their own communities.

“It left a deadly mark on my face that hindered me from associating with people in the community,” Okanlawan said. “Imagine a life where people are running away from you because of your condition. I used to cry every day. I was alone.”

Noma results from deadly synergy between bacterial pathogens that causes ulcers to develop in the mouth, followed by the destruction of cells in the tissues and bones of the face. Often referred to as “the face of poverty,” its key risk factors include malnutrition, lack of basic hygiene, contaminated drinking water, immunodeficiencies, and recent illness, especially from malaria or measles.

Okanlawan has since received several reconstructive facial surgeries at the Sokoto Noma Children’s Hospital, the only specialised noma hospital in Nigeria since its founding in 1999. Little by little, Okanlawan found a new lease on life.

“I began to admire myself,” she said. “I began to relate with people in the community.”

After returning to school to complete her education, Okinlawan returned to Sokoto, where she now works as a hygiene officer and helps patients recover from the trauma of disfiguration.

WHO decision due in 2023

Despite years of campaigning from medical organizations and national governments, noma has yet to be included in the World Health Organization’s neglected tropical diseases list, an omission Médecins Sans Frontières (MSF) health advisor for Nigeria Mark Sherlock says makes noma “the most neglected of the neglected diseases.”

But this may be about to change. In late January, the Federal Ministry of Health of Nigeria, supported by 30 member states from five WHO regions, submitted a dossier on noma requesting the formal recognition of noma as a neglected tropical disease (NTD).

The request is a follow-up to the resolution on oral health passed by WHO at the 74th World Health Assembly in 2021, which recommended that “noma should be considered for inclusion in the NTD portfolio as soon as the list is reviewed in 2023.”

The latest WHO statistics – updated in 1998 – estimate 140,000 people are affected by noma every year. No systematic study of its disease burden has been conducted in the intervening 25 years.

The WHO’s Strategic and Technical Advisory Group for Neglected Tropical Diseases is supposed to make a final decision on whether to add noma to its list of neglected tropical diseases this year, but a date for the meeting has not yet been published.

Not a “silver bullet”, but noma belongs on the list

Amina, an 18-year-old noma patient from Yobe state, visited the Sokoto Noma Hospital for the first time in November 2016 with her mother. She has been disfigured since early childhood, and has a habit, like many noma survivors, of hiding her scars behind a veil. (MSF, Sokoto, Nigeria.) 
18 October, 2017.

Despite its omission from the official WHO list, Noma is the quintessential neglected disease.

It disproportionately affects people living in extreme poverty, is generally neglected by research, affects populations in tropical and sub-tropical areas of Africa, Asia, and Latin America, and incurs significant socio-economic costs on the communities it affects.

Its high mortality rate can also be attributed to neglect and lack of awareness education among the public and medical communities due to the highly treatable and preventable nature of the disease.

“Due to extreme poverty and lack of awareness, unfortunately, a lot of children die at home without even making it to the hospital,” said Dr Shafiu Isah, Chief Medical Director at the Sokoto Noma Children’s Hospital. “This disease is still not very well known in our communities, including among health care workers, who often mistake it for cancer or other illnesses.”

Doctors, researchers and activists recognize that the inclusion of noma on the WHO list would not change the situation of patients on the ground overnight, but say recognition of its neglected status would shine a much needed spotlight on a disease in dire need of renewed resources and attention.

“Whilst not a silver bullet, noma’s inclusion on the WHO list will draw attention to the disease and those at risk of or experiencing it, attract funding for research, prevention, and treatment, and integrate noma in existing protocols of disease-monitoring,” said Dr Ioana Cismas, co-lead of the research collective The Noma Project.

“Those who have lived experience of this disease are calling for national and international action.”

Read more: Noma Survivors Demand that WHO List the Disease as a Neglected Tropical Disease

Image Credits: Claire Jeantet – Fabrice Catérini / Inediz’.

Assistant Director-General Dr Tereza Kasaeva, WHO’s interim head of NCDs

Higher taxes and warning labels on unhealthy food, cigarettes and alcohol, and better screening for cancers, are on the World Health Organization’s (WHO) updated list of “best buys” to address non-communicable diseases (NCD) discussed by member states at the body’s Executive Board meeting on Thursday.

The list was updated in response to the lack of progress to reduce NCDs, with not a single country on track to achieve the 2025 global targets set by the World Health Assembly back in 2013, and the declaration by the UN General Assembly High-Level Meeting on NCDs in 2018.

The new list now recommends 112 interventions and enabling actions – up from 88 when it was last updated in 2017, and the global body has also worked out which are the most cost-effective.

There was wide support for the new list from member states. However, civil society representatives criticised its silence on kidney disease, dementia, obesity co-morbidities, as well as a lack of attention to older people more likely to have NCDs.

Lack of progress

In his report on progress made to address NCDs, WHO Director-General Dr Tedros Adhanom Ghebreyesus noted that health systems were failing to prevent and control these diseases.

“The [COVID-19 pandemic] has highlighted the urgent need to strengthen health systems through a radical reorientation towards primary health care as the foundation for progress towards universal health coverage, as well as to ensure health security and achieve health and well-being for all,” said Tedros. 

“The prevention and control of NCDs and the promotion, protection and care of mental health are integral to this reorientation.”

The cost of implementing the interventions in 76 low and lower-middle-income countries is less than US$ 1 per person per year, and together these actions could save seven million lives per country, according to the WHO.

However, Botswana, on behalf of the Africa region, requested that more affordable treatments are developed to assist lower-income countries.

Mental health remains neglected

“Between now and 2030, the economic gains from implementing the cost-effective NCD interventions could amount to more than $230 billion in lower-middle income countries when individual, economic and social benefits are factored in,” according to Tedros, who noted that almost three-quarters of deaths were caused by NCDs.

Almost a billion people globally lived with a mental disorder. A massive 283 million people had alcohol use disorders in 2016 and 36 million with drug use disorders in 2019, yet less than a third of member states had mental health policies and plans and only 2% of health budgets go to mental health. 

Denmark, on behalf of the European Union, called on the WHO to “strengthen the efforts for mental health and have a greater focus on information sharing and de-stigmatization efforts”.

Deputy Director-General Dr Zsuzsanna Jakab told the EB at a session on Thursday night that the best buys would “invigorate implementation of both the global action plan and relevant regional frameworks”.

‘We know these approaches work. In Southeast Asia for example, we have seen a rapid decline in tobacco use. Smoking prevalence among men in the region declined from 50% in 2000 to 25% in 2020,” said Jakab.

Assistant Director-General Dr Tereza Kasaeva, WHO’s interim head of NCDs, recommended that member states “define the list of priorities that are considered good value for money according to their national context”, and WHO would support them to implement these.

The list will continue to be updated as more evidence became available, added Kasaeva.

World Health Organization
The World Health Organization celebrates its 75th anniversary.

The world has changed since the World Health Organization (WHO) was founded 75 years ago. Established as the specialized health agency of the United Nations in 1948, WHO has played a critical role in addressing global health challenges, disease control, and providing health services to neglected populations ever since. 

This week, global health leaders gathered for a panel alongside the agency’s 152nd Executive Board meeting to discuss the future direction. Vast advances in medical science mean that the challenges the WHO faces today are different from those in its past, but not any less numerous. From climate change to growing global economic inequalities, to pandemics like COVID-19, global health is under attack on all fronts. 

Between technological advancements in artificial intelligence, medical science, and digital health systems and the threats of climate change, growing economic inequalities and future pandemics, the global health picture for the coming 25 years is as menacing as it is hopeful. 

“By 2050, the future of health will be significantly different,” WHO Director-General Dr Tedros Adhanom Ghebreyesus said. “Robots in the operating room – I think initially was science fiction – but that happened in 1998, and now is very common,” he added, highlighting the exponential pace of scientific advancement. 

“But it’s not the last 75 years that matter now, it’s the next 75 years,” Tedros said. “All roads must lead to universal health coverage. So the question is, how do we create a future that will bring health to everybody?”

Too slow to adapt: WHO must modernize

The United Nations, World Bank, and International Monetary Fund have come under fire in recent years for their inability to modernize.

Like its sister United Nations agencies and the multilateral development banks created to underpin the post-war international order, WHO has been slow to adapt to the ever-increasing pace of change in the modern world. 

“WHO was established 75 years ago. Its processes, its structures, and most importantly its mindset are stuck in the time 75 years ago when it was established,” said Bruce Aylward, Tedros’s Senior Advisor on Organizational Change. 

Achim Steiner, head of the UN Development Programme, echoed Aylward, saying the UN and its agencies must pivot away from being products of “post-Second World War realities” and towards 21st-century opportunities. 

Despite the slow pace of institutional change, WHO has achieved some historic victories. The eradication of smallpox in 1980, a virus estimated to have killed over 300 million people since 1900 alone, is justly seen as a medical miracle.

Efforts by WHO and partners also spearheaded the global campaign against polio, leading to a 99% decline in cases since the launch of the Global Polio Eradication Initiative in 1988, and led the charge in the fight against HIV/AIDS, providing technical and financial support to affected countries and working to improve access to treatment, care and prevention services.

But it has also faced its share of criticisms. Recent examples include its slow response to the 2014 outbreak of Ebola on the African continent and its handling of the early stages of the COVID-19 pandemic in 2020, when many argued that WHO was too slow to declare a global health emergency and coordinate a global response.

The agency is also chronically underfunded. With a budget of just $6 billion for the 2022-2023 period, the agency’s vast mandate often clashes with tight financial restrictions limiting what it can accomplish. A lack of trust in WHO within the communities it works with has also been a major obstacle to achieving its goals.

“If we had the trust of the communities we were working with, Ebola would have stopped way fast. COVID would have been managed way better,” Aylward said. “So we’ve got to be trusted in a way we aren’t today. We’re going to have to earn that.”

Civil society and younger generations need to be more involved

The WHO Youth Council held its inaugural meeting this week.

Part of the modernisation programme undertaken by WHO under Tedros’s leadership is the creation of the Youth Council, a network of youth representatives from health and non-health organizations aiming to leverage the “expertise, energy and ideas” of younger generations to assist WHO decision-making. 

“If you want to do something for young people, you have to involve young people,” said Dr Kerstin Vesna Petrič, chair of the WHO Executive Board. “The same is true if you want to do something for the most vulnerable, or for society in general: you have to involve civil society.”

The Youth Council met for the first time just four days ago, nearly 75 years after the agency’s establishment. Two other bodies – the Science Council, a research division, and the Innovation Hub, an accelerator programme – were established in April and May 2021 respectively. 

That these bodies are new reveals the historically insular nature of WHO, but also reflects a wider shift within the organization to expand its horizons beyond the bubble of the health world. 

“We have to move away from being a sectoral organization to a much broader one,” Aylward said. “It should be self-evident at this point: civil society has part of the answers, and the private sector has a big part of the answers.”

Nanjira Sambuli, a researcher and policy analyst at the civil society group Digital Impact Alliance, noted how long it has taken international institutions to engage with communities and stakeholders beyond Geneva.

“Multilateralism over the last 25 years has not really been a system accustomed to working with outsiders,” she said. “But I’m convinced that at the very least if we can leave behind systems and institutions that have done the groundwork, this generation that is inheriting these complexities lead the charge.”

UN agencies working as one

In an era of overlapping crises, WHO and its sister UN agencies have realized the need to deepen collaboration – a shift UN Development Programme director Achim Steiner said must continue. 

“We need integrated approaches. Health is as much dependent on addressing poverty as poverty is a way in which we have to look at the impact of climate change, and the need for adaptation,” Steiner said. 

An example of this kind of integrated approach is the WHO’s One Health Initiative, which launched its first joint plan of action at the World Health Summit in Berlin in October last year. 

The plan – a collaborative effort with the Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), and the World Organisation for Animal Health (WOAH) – aims to break down the silos that have historically separated the work of these agencies to address threats to both health and the environment.

“We have to believe in interdependence,” Tedros said.

Digitization does not fix inequality

As the health systems in rich countries speed into the digital age, nearly one billion people are still treated in health facilities without reliable electricity, or none at all.

One of the inescapable forces driving changes to health systems is digitization. The potential for digitization to accelerate the progress of healthcare systems, improve in quality of care, and assist the world in achieving the Sustainable Development Goal of universal health coverage is enormous.  

But the speed of digitization, and the infrastructure needed to benefit from it, threatens to leave some of the world behind – and create new inequalities.

“Digital technologies will amplify what already exists,” said Nanjira Sambuli, a researcher and policy analyst at the civil society group Digital Impact Alliance. “We must not fall into the trap of imagining that poorly functioning public health systems can merely leapfrog ahead into the digital age.”

As developed countries enter a new era of digitized health systems, nearly one billion people in low- and middle-income countries lack access to health facilities with reliable electricity, with over 430 million people served by facilities with no electricity at all.

“Digital public infrastructure and a deep commitment to equitable access are fundamental,” Steiner said. “At the end of the day, much of what happens in our world is ultimately premised on either the ability to invest, to buy, or to afford to pay for a service.”

‘The World Happiness Organization’

As the panel drew to a close, a final question was raised: should the WHO consider a change in name to reflect the new scope of the organization’s definition of health – perhaps to “The World Happiness Organization”, the moderator mused.

Tedros said he saw no need to change the acronym – after all, as long as human beings are around, there will be health issues to contend with – suggesting instead that the world’s defence ministries that shift their mission towards happiness, and away from war.

“Two trillion US dollars a year are being spent on defence, to kill each other,” Tedros said.  “Then when we say we need more money for health, it doesn’t exist.”

The budget of the WHO is currently $6 billion, 0.3% of what the world spends on defence.  

Image Credits: United States Mission Geneva, John Samuel.

12 African leaders pledge to end HIV in children by 2030

DAR ES SALAAM, Tanzania – Twelve African nations pledged on Wednesday to end AIDS in children by 2030, focusing on ensuring that life-saving antiretroviral (ARV) medication reaches children.

The pledge – known as the Dar es Salaam Declaration – was adopted at the first ministerial meeting of the Global Alliance to end AIDS in Children. The Alliance was formed during the International AIDS Conference in Canada last July.

Speaking during the meeting, Winnie Byanyima, Executive Director of UNAIDS said that the meeting had given her hope: “An inequality that breaks my heart is that against children living with HIV, and leaders today have set out their commitment to the determined action needed to put it right.”

According to her, today’s advanced medical science dictates no baby needs to be born with HIV let alone get infected during breastfeeding and no child living with HIV needs to be without treatment.

The work will centre on four pillars: early testing and treatment; ensuring  that pregnant and breastfeeding women do not pass the virus on to their babies; preventing new HIV infections among pregnant and breastfeeding adolescent girls and women; and “addressing rights, gender equality and the social and structural barriers that hinder access to services”.

Death every five minutes

Currently, around the world, a child dies from AIDS-related causes every five minutes, UNAIDS said in a statement.

Only 52% of children living with HIV are on ARVs in comparison to 76% adults are receiving antiretrovirals, something that the World Health Organisation(WHO) has described as “one of the most glaring disparities in the AIDS response”.

In 2021,160 000 children were infected with HIV. Although children comprise just 4% of people living with HIV, they account for 15% of all AIDS-related deaths, according to UNAIDS Global AIDS updates 2022.

Tanzania is among 12 countries with a high HIV burden that have since joined the alliance.

Others are Angola, Cameroon, Côte d’Ivoire, the Democratic Republic of the Congo (DRC), Kenya, Mozambique, Nigeria, South Africa, Uganda, Zambia, and Zimbabwe.

Tanzania’s Health minister Ummy Mwalimu (centre) welcomes Vice President Philip Mpango

Three UN agencies — UNAIDS, UNICEF and the World Health Organization (WHO) — are behind the initiative, along with the Global Network of People Living with HIV (GNP+), the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan For AIDS Relief (PEPFAR).

Tanzania’s Vice-President, Philip Mpango, called upon nations to “commit to moving forward as a collective whole”. 

“All of us in our capacities must have a role to play to end AIDS in children. The Global Alliance is the right direction, and we must not remain complacent as 2030 is at our doorstep,” he said.

Zimbabwean Vice-President Constantine Chiwenga said that governments worldwide had lost ground in the fight against HIV/AIDS because of the COVID-19 pandemic, and he urged global health leaders to continue the fight.

“We got affected, just like any other country, when the COVID-19 pandemic hit us,” he said.

Zimbabweans “completely forgot” about HIV/AIDS as they grappled with COVID-19, and as a result, the country’s mother-to-child HIV transmission rate had increased to 8.9%.

“Let us come up with concrete measures which will make sure the spread of HIV/AIDS is brought to a halt,” he said. 

First Lady of Namibia Monica Geingos said that “this gathering of leaders is uniting in a solemn vow – and a clear plan of action – to end AIDS in children once and for all. There is no higher priority than this.” 

UNAIDS believes that progress is possible as 16 countries and territories have already been certified for validation of limiting mother-to-child transmission of HIV and or syphilis.     

While HIV and other infections can be transmitted during pregnancy or breastfeeding, prompt treatment, or pre-exposure prophylaxis (PrEP) for at-risk mothers, can interrupt the process.  

Last year, Botswana became the first African country with high HIV prevalence to be validated as being on the path to eliminating vertical transmission of HIV, meaning the country had fewer than 500 new HIV infections among babies per 100,000 births. The vertical transmission rate in Botswana is now 2% from 10% a decade ago

Women of reproductive age in sub-Sahara Africa are disproportionately affected by HIV/AIDS, Dr Assery Mchomvu, a senior obstetric and gynaecologist at Dar es Salaam’s Mission Mikocheni Hospital, told Health Policy Watch.

“HIV positive women now have a greater opportunity to pursue childbearing goals, with fewer consequences,” said Mchomvu.

But he said that the fight against HIV/AIDS can only be won if there was a coordinated global response to curb new infections and unlimited access to treatment for those already affected.

Wide support

In 2021, 65,000 people died from AIDS-related illnesses, and 1.5 million people were infected with the deadly virus, according to UNAIDS data. And although deaths are down over the last decade, the number of new infections has essentially reached a plateau.

The UN Children’s Fund (UNICEF) welcomed the leaders’ commitments and pledged the agency’s full support. “Every child has the right to a healthy and hopeful future, but for more than half of children living with HIV, that future is threatened,” said UNICEF Associate Director Anurita Bains.

 Peter Sands, Executive Director of The Global Fund, said no child should be born with HIV in 2023 and no child should die from AIDS-related illness. “Let’s seize this opportunity to work in partnership to make sure action plans endorsed today are translated into concrete steps,” said Sands.

“With our country-led partnership model, we provide funding for HIV programmes in over 100 countries. The Global Fund supports HIV prevention and treatment programmes for children and adolescents, including access to early infant diagnosis, innovative testing approaches and family-focused service delivery.”  

Dr John Nkengasong, head of the US President’s Emergency Plan for AIDS Relief (PEPFAR), said that closing the treatment gap for children requires “laser focus and a steadfast commitment to hold governments, and other partners accountable for results”.

“PEPFAR commits to elevate the HIV/AIDS children’s agenda to the highest political level within and across countries to mobilize the necessary support needed to address rights, gender equality and the social and structural barriers that hinder access to prevention and treatment services for children and their families,” said Nkengasong.

“We have ensured that human rights, community engagement and gender equality are pillars of the alliance,” said Lilian Mworeko, Executive Director of the International Community of Women living with HIV in Eastern Africa. “We believe a women-led response is key to ending AIDS in children.”

Image Credits: Peter Mgongo.

A doctor provides health services to children in a refugee camp in northwest Syria during the COVID-19 pandemic.

The World Health Organization (WHO)’s  ‘zero-draft’ of a pandemic treaty proposes that 20% of pandemic-related products – vaccines, diagnostics, personal protective equipment and therapeutics – should be allocated to the global body, which will then ensure their equitable distribution.

The draft, which has been seen by Health Policy Watch, was sent to the WHO’s 194 member states this week, officially opening the door for negotiations on how the world should behave in future pandemics.

According to the draft, half of the pandemic products allocated to WHO (10% of total global production) should be donated while the other half would be bought for an “accessible” price.

No less than 11 of the draft’s 49-clause preamble deal in one way or another with intellectual property rights, signalling the key battleground for upcoming negotiations.

These clauses recognise that “protection of intellectual property rights is important for the development of new medical products”, but highlight their impact on price and access.

‘Use IP waivers’

In the text itself, member states are directed to “take appropriate measures to support time-bound waivers of intellectual property rights that can accelerate or scale up manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability and adequacy of affordable pandemic-related products”.

In addition, parties (member states) are encouraged to “apply the full use of the flexibilities provided in the TRIPS Agreement” and encourage all patent-holders of pandemic-related products to “waive, or manage as appropriate, payment of royalties by developing country manufacturers”.

Manufacturers that get significant public financing will also be encouraged to waive royalties on the continued use of their technology for the production of pandemic-related products. 

Health activist Jamie Love, director of Knowledge Ecology International (KEI), described the draft as being “surprisingly strong on several topics” including intellectual property.

The pandemic treaty is being developed in reaction to what the draft describes as “the catastrophic failure of the international community in showing solidarity and equity in response to the coronavirus disease”. 

Put together by the intergovernmental negotiating body (INB) bureau, the draft will be negotiated in this body – and it is unlikely to survive in its current form given the strong pharmaceutical lobby, particularly in the European Union.

The next meeting of the INB is on 27 February, with the final version of the accord expected to be tabled at the WHO’s 2024 World Health Assembly.

‘Nothing agreed’

The zero draft states it has been developed “without prejudice to the position of any delegation and following the principle that ‘nothing is agreed until everything is agreed’. “

While the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) was still analysing the draft, it described its release as “an important milestone in the negotiation process of the WHO Accord”.

“The innovative pharmaceutical industry has been at the forefront of the response to the current pandemic and as a result is uniquely positioned to contribute to future pandemic preparedness discussions,” according to the IFPMA. 

“We will continue to constructively engage in these negotiations, by emphasizing the lessons learned from the COVID-19 pandemic, and bringing proactive solutions to the table, such as Berlin Declaration.”

Building from the ‘bottom up’

Meanwhile, Dr Mike Ryan, WHO’s executive director of health emergencies, told the WHO’s executive board (EB) on Wednesday morning that the conditions conducive for pandemics – war, hunger, epidemics and natural disasters – were “converging with unprecedented frequency and intensity”.

“Currently, WHO is responding to 55 graded emergencies around the world, which is unprecedented,” said Ryan. “Last year, we supported member states in response to over 75 different health emergencies around the world.

“Over 339 million people are now in need of direct humanitarian assistance, and within those countries affected by fragility and conflict, we’re seeing 80% of the world’s major epidemics occurring.”

Ryan urged countries to build their national action plans for public health security alongside the INB negotiations, stressing that “global health security builds from the bottom up”.

Image Credits: Flickr – Trinity Care Foundation, International Rescue Committee.

Dr Tedros reporting on WHO efforts to root out sexual misconduct

A special unit to address sexual ‘misconduct’, a fund to support survivors in the Democratic Republic of Congo (DRC) and training for all staff are some of the steps taken by the World Health Organization (WHO) to rid itself of exploitative behaviour.

This follows the scandal that played out during the Ebola outbreaks in the DRC between 2018 and 2020, during which 83 women were sexually exploited and abused by WHO staff and allied agencies.

WHO Director-General told the global body’s Executive Board (EB) meeting on Tuesday that 90% of the 150 activities identified by the management response plan to address sexual “misconduct” – the catch-all phrase adopted by WHO – had been completed.

A $2 million fund has been set up to support 83 women in the DRC, some 20 of whom had given birth after their ordeals. Of the 83 women, 23 are “survivors of alleged sexual misconduct by WHO personnel and the other 60 are survivors of alleged sexual misconduct by employees of other agencies,” said Tedros, adding that the WHO was the only UN agency to have set up such a mechanism. 

“In DRC, we have worked with local organisations to reach more than 30,000 at-risk communities. We’re also offering free legal aid to survivors so they can pursue legal action,” he added.

Discrepancies between WHO and UN reports

However, Tedros said that there were a number of discrepancies between the WHO’s report and that of the UN Office of International Oversight Services (OIOS), which had also been investigating allegations of sexual misconduct during the Ebola outbreak in DRC.

According to Tedros, the OIOS had investigated the managerial mishandling of sexual misconduct in DRC and found “that the allegations of managerial misconduct against the three staff members identified by the independent commission were unsubstantiated”. 

“Those staff, who are on administrative leave, are returning to active service,” added Tedros, adding that the WHO has asked its independent external oversight advisory committee to help it to address these discrepancies with OIOS.

In relation to allegations of sexual misconduct by a WHO staff member during the World Health Summit in Berlin last October, Tedros said that the investigation team had completed its report and the case has advanced to the Global Advisory Committee.

“Once that Committee’s review is completed and if the allegations are substantiated disciplinary action will be taken,” said Tedros, who expressed regret that the media had identified the alleged perpetrator.

Dr Temo Waqanivalu, who heads WHO’s work on integrated delivery of noncommunicable disease services, was named by AP as the staff member who is reportedly the focus of a WHO investigation into the Berlin incident. A prior complaint had been made against Waqanivalu in 2017, but the WHO officials did little about it, according to the AP.

“Media reports indicating that at least one individual working in WHO recently alleged to have engaged in misconduct, and having had a record of prior accusations, really needs to be addressed by WHO,” said Loyce Pace, US Assistant Secretary of State for Global Public Affairs, at the EB.

“It’s important to many of us who have faced this personally, in our experience working in the global health and development space, and not just in terms of earlier in our careers, but even now, as seasoned global health professionals,” said Pace.

“There are many of us who stand with survivors and stand with those who identify as victims and are truly committed but also frustrated by where things have stood to date, and hope that we can all come together to do right by people like me, who have these stories to tell,” added Pace.

Loyce Pace, US Assistant Secretary of State for Global Public Affairs.

Zero tolerance

Some 90% of WHO staff had completed UN courses on sexual misconduct, while training had also been run for implementing partners and communities, according to Tedros.

As part of its reform of the policies, systems, structures and culture of WHO “to make zero tolerance a reality, not just a slogan”, all regional offices now have dedicated teams to work on sexual misconduct, he added.

Each of the 340 country offices had a focal person for sexual misconduct in all country offices, and all are being trained, while the head office’s department for the prevention of and response to sexual misconduct is “now fully staffed and coordinating our organisation-wide efforts”.

Tedros described reform of the Department of Internal Oversight Services (IOS) and the establishment of dedicated capacity for investigation of sexual misconduct as “one of the central and most impactful parts of our work in 2022”.

“The changes we have made have increased confidence and trust in our systems, as evidenced by tripling in the number of people coming forward with complaints from 166 in 2021 to 491 in 2022,” said Tedros.

“As promised, we cleared the backlog of sexual misconduct allegations by May of last year. The investigation team is now working on cases in real time because justice delayed is justice denied. We have set and have met a target of 120 days in which to complete investigations into allegations of sexual misconduct.”

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WHO EB 2023

One by one, countries demanded the World Health Organization (WHO) spend more on their countries’ needs while debating a proposal to shore up the U.N. health agency’s finances through a replenishment fund, that would be filled by periodic donor drives.

The discussion, which centred around demands to shift spending from WHO’s Geneva headquarters to budget-strapped WHO offices in over 100 low- and middle-income countries  dominated Tuesday’s morning session of its Executive Board (EB) meeting.

For the first time, more than half of WHO’s 2024-25 budget is earmarked for country offices. Despite an overall budget shortfall, African delegations want this increased to 75%. Historically, the region which bears the world’s biggest burden of many diseases, has also suffered from the biggest lack of resources. 

“The uneven funding of this biennium seems to be a repeat of the uneven funding from the previous biennium,” said Mahlet Hailu Guadey, Ethiopia’s Deputy United Nations Ambassador in Geneva, representing the African Union.

Guadey called for the WHO’s Secretariat to review what she described as uneven funding amongst priorities and regions.

The United States, one of WHO’s biggest financial backers, also repeated its conditional approval for increasing WHO’s assessed fees to countries, as long as those increases are  accompanied by new processes ensuring more internal controls and accountability.

Other nations, however, such as Poland, tried to put the brakes on more spending given the financial drain of global crises and conflicts, ranging from the COVID-19 pandemic to Russia’s war in Ukraine.

Flexible funding

Tuesday morning’s EB session was dominated by debate over a plan by WHO’s Programme, Budget and Administration Committee (PBAC) to support a ‘replenishment fund’ for urgently needed flexible funding. The fund would be modelled on the successful funds managed by agencies like The Global Fund and Gavi, the Vaccine Alliance, which succeed in raising billions of dollars through high-profile pledging events, staged every three to four years. 

While expressing support for WHO’s overall goals, EB delegates criticized a system they characterized as a top-heavy bureaucracy that spends too much money on its own divisions and processes instead of in-country programmes.

The EB’s chair, Slovenia’s Dr Kerstin Vesna Petrič, noted the prevailing sentiment to support the use of a replenishment fund filled by voluntary donations from both member states and philanthropies at high-profile events.

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EB’s chair, Slovenia’s Dr Kerstin Vesna Petrič

“I can see we all agree that more money should be given to the member states, but by this, we should all bear in mind that more responsibility will be given to the member states,” Petrič told the meeting.

Put on the defensive, Raul Thomas, WHO’s Assistant Director-General for Business Operations, told delegates that “every $1 invested in the World Health Organization results in a $35 return on investment” and asserted “this is the most heavily consulted budget ever.”

WHO’s Director-General Dr Tedros Adhanom Ghebreyesus tried a bit of diplomacy to bridge the gap between the main funders and those feeling their needs were not getting met. He began by agreeing with the general assertion that countries must be the main focus.

“I think if we’re going to raise the capacity of our programs it will depend on the strength of our country offices,” he said. “We have to equip them with everything.”

Tedros outlined a funding strategy ranging from an immediate focus for the next 100 days to more mid- and long-term planning, with the ultimate goal of turning country office heads into true leaders.

“We cannot use them as messengers, which very often happens,” he said. “Resource allocation is at the center; it’s one of the areas where we said we must make significant progress. And it will be a game changer.”

Tedros explained, as he often has in the past, that WHO’s income comes from two principal sources. One is assessed contributions, which comprised only around 14% of the last budget. These are the annual, compulsory dues that 194 member nations pay, using a formula based on each nation’s GDP.

Members’ dues provide a stable, predictable source, and the funds can be used as needed for global health priorities.

The other 86% of the budget comes from voluntary contributions by member nations, philanthropic foundations and other donors, and usually covers only short-term projects meaning that funding is less flexible because it’s earmarked and is also not guaranteed.

“What we’re saying now cannot happen if we’re going to rely on 86% of contributions from voluntary and earmarked where it should be spent,” Tedros told the EB. “This is a very opportune time but it’s also a crossroads.”

Only 14% of budget covered by members’ dues

The proposed 2024-25 budget being considered by the EB emphasizes the need for sustainable financing.

“The pandemic highlighted WHO’s longstanding challenge of sustainable financing. The organization’s ability to make an impact is limited by a funding model in which only 14% of WHO’s funding is fully flexible and predictable (while the remaining funds are dependent on generous donors, heavily earmarked and arrive at unpredictable times),” the budget says.

In May 2022, it notes, WHO’s member nations made a landmark decision to increase assessed contributions to represent 50% of the base programme budget by 2030–2031.

The draft proposed programme budget for 2024–2025 “benefits from this decision – it has been developed on the expectation of a 20% increase of assessed contributions (from the approved levels of 2022–2023), marking a historic move towards a more empowered and independent WHO,” it says. “This development reflects the increased trust in WHO to serve its member states.”

Rather than complaining about WHO’s funding, nations can make recommendations for fixing the system by engaging in efforts to “help us see whether the formula we’re using is wrong or not,” Tedros suggested. “If the formula – the allocation mechanism – is faulty, then definitely the sharing will not be right and you will not have a right to complain.”

The EB is expected to discuss the PBAC proposal further this week, before deciding whether to pass the initiative to a vote by the World Health Assembly in May.

Currently, member state assessments cover only about 16% of WHO’s budget needs. At last year’s World Health Assembly, nations agreed to cover half of WHO’s core budget through assessed contributions from member states by the year 2030, with an initial stepwise increase of 20% for this budget year.  That, however, still leaves a major shortfall in the agency’s annual budget of about $3 billion annually, underlining the need for a replenishment fund, proponents say.