The World Health Organization announced Wednesday that it would implement a pilot programme to include human insulin products in its Prequalification of Medicines programme, in an effort to expand access to treatment for diabetes in low- and middle-income countries. The move is the first in a series of steps WHO is taking to address the growing burden of diabetes, which is now one of the top ten leading causes of death around the world.

“Diabetes is on the rise globally, and rising faster in low-income countries,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press release. “Too many people who need insulin encounter financial hardship in accessing it, or go without it and risk their lives. WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it.”

Human insulin has been on the WHO Essential Medicines List since 1977, which guides many national government decisions about products to support in public health services. However, only about half of the 65 million people with Type 2 Diabetes who need insulin can actually access it, WHO estimates, due to the high prices of insulin products and unavailability in public health facilities.

Currently just three pharmaceutical companies – Novo Nordisk, Eli Lilly, and Sanofi – control most of the global market for insulin products, and prevailing prices remain prohibitive for many people and low-income countries, and even in some high-income groups as well.

Including insulin in WHO’s Prequalification of Medicines programme, would make it more attractive for new competitors to enter the market – by submitting proposals to WHO review for production of quality-assured insulin products at lower prices. WHO prequalified products also are used as the basis for many donor-supported initiatives to make bulk purchases of products at preferred prices for low- and middle-income countries.

The ultimate result, WHO officials believe, would be an increase in the number of quality-assured human insulin products on the international market, and a wider range of choices for patients at lower prices.

“Prequalifying products from additional companies will hopefully help to level the playing field and ensure a steadier supply of quality insulin in all countries,” said Dr Mariângela Simão, assistant director general for Medicines and Health Products at WHO.

A WHO spokesperson told Health Policy Watch that already, at least three new market entrants have informally expressed their interest in applying for WHO Prequalification as part of the pilot.

“Clearly we hope more come forward now that the pilot is official, because clearly the more companies that meet international quality standards, the larger the chance that insulin will become affordable,” said the spokesperson.

The target WHO assessment time is 270 days, meaning if companies submit their applications within the next few months, new WHO-prequalified products could be on the market as early as this time next year.

Prequalification is a process in which WHO evaluates the quality, safety, and efficacy of medical products and issues guidance on their use. Many low- or middle-income countries also see WHO prequalification of a product as a stamp of approval to begin registering the health product for use in their own countries.

Access To Insulin A Global Challenge

From 2016-2019, human insulin was available only in 61% of all health facilities and analogue insulins (altered forms of human insulin) were only available in 13%, according to WHO data from 24 countries. The data showed that a month’s supply of insulin would cost the average worker in Accra, Ghana almost a quarter of their monthly income.

Even in high-income countries, the high price of insulin results in many people rationing its use, which can be deadly for people who do not receive the appropriate daily dose.

Globally, some 422 million people live with diabetes. Diabetes is the seventh leading cause of death globally and a major cause of costly and debilitating complications such as heart attacks, stroke, kidney failure, blindness and lower limb amputations.

People with Type 1 diabetes need insulin for their very survival and to maintain their blood glucose at levels to reduce the risk of common complications such as blindness and kidney failure. People with Type 2 diabetes need insulin for controlling blood glucose levels, and to avoid further complications when oral medicines become less effective as the illness progresses.

Decision Follows Debate Over Inclusion of Analogue Insulin in WHO Essential Medicines List 

WHO’s decision to pilot human insulin prequalification also follows a contentious debate earlier this year over the proposed inclusion of still more pricey insulin analogues (altered forms of human insulin) in WHO’s Essential Medicines List (EML). The list is used by many countries as a basis for national decisions on the basket of medicines to be procured, offered or supported.

Civil society, scientific experts, and patient access groups opposed the petition to include analogues in the EML, arguing that including these products without addressing the lack of competition in the insulin space could send the wrong message to governments, making analogue insulin the new norm. And that could actually drive up prices that low- and middle- income countries were paying for insulin products.

The Pre-Qualification initiative appears aimed at addressing some of those existing needs and gaps. Health Action International (HAI), one of the same civil society groups that opposed the petition to include analogues in the EML, commended the WHO’s decision to include human insulin in the prequalification program.

Dr. David Beran, University of Geneva professor and co-lead investigator of a HAI study group focusing on insulin access (ACCISS) expressed his hope that WHO’s decision will impact the limited competition in the insulin market in a statement released by the group. “This initiative should ultimately lead to greater competition and hopefully lower prices, thus improving affordability for people and health systems.”

This story was updated November 14.

Image Credits: WHO.

Nairobi, Kenya  – A three day summit marking 25 years since the historic UN Conference on Population and Development (ICPD) in Cairo opened here in the Kenyan capital on Tuesday, with a focus on actions that save mothers’ lives, make contraception and family planning more accessible, and end violence against women and girls.

But as the Nairobi Summit (ICPD25)  kicked-off under the theme “Accelerating the promise,” abortion opponents and faith-based groups were holding a parallel meeting at a Catholic church next to the venue, saying that the meeting didn’t reflect their views and positions.

“The reproductive rights of women and girls are not up for negotiation. We shall protect and uphold them. Reproductive rights are human rights and we will not back down,” Natalia Kanem, United Nations Population Fund (UNFPA) executive director said in the opening session, in an oblique reference to the protests outside.

The Nairobi ICPD25 Summit is organized by the government of Kenya and Denmark, and the UNFPA. About 12,000 people from 160 countries, ranging from heads of state, ministers and parliamentarians to hundreds of representatives of non-governmental organizations, are set to attend.

Natalia Kanem, Executive Director of the UNFPA, speaks at the ICPD25

“The purpose of the conference is not to talk about ‘what’, but to discuss ‘the doing’. The goal is to speed up the momentum,” Kanem told a news conference on November 12. “We have to finish the intended business of the ICPD. [This] remarkable turnout gives me confidence we will reach the goal by 2030.”

Discussions are focusing on five themes; sexual reproductive health as part of Universal Health Coverage; funding required to realise ICPD’s programmatic goals; demographic diversity and its power to drive economic growth and sustainable development; measures to end gender-based violence and harmful practices; and the right to sexual and reproductive health care.

“We need more action,” said Rasmus Prehn, Denmark’s Minister for Development Cooperation. “The summit is about how, but not what to accelerate.”

 

Women’s Rights & Well-Being Key to Prosperous Societies

In an opening address, Kenya’s President Uhuru Kenyatta said the large numbers of conference attendees confirmed the premise that advancing people’s rights, and in particular women’s rights, choices and well-being, is the path to prosperous and resilient societies.

“… Our women are the gatekeepers to family health; they exert such a powerful influence on intergenerational outcomes for their children. Empowering women essentially empowers all our families, empowers our societies, empowers our nations and it empowers the world,” said Kenyatta.

In the milestone 1994 meeting in Cairo, 179 governments called for the empowerment of women and girls in all spheres of their lives, including in areas regarding sexual and reproductive health.

Since then, Kenyatta said, the world had changed a great deal, with respect to population and development-related issues.

“The world faces increased health threats including threats from reproductive cancers such as breast, cervical and prostate cancer. And there are also growing environmental pressures including the urgent threat of climate change,” said the Kenyan leader, while adding that these health challenges had made the Cairo commitments more urgent and more complex.

Significant achievements in strengthening maternal health care, and expanding access to quality contraception information and services, are being highlighted at the event. At the same time, speakers have underlined that millions of women and girls have not befitted from those gains.

“…let us bear in mind the fact that the most important participants in this Summit are actually not in this Conference,” said Kenyatta. “I am referring to the 1-in-5 women from all corners of the world that this year alone, will experience gender-based violence, most likely from someone who is close to them.”

Closing Equity Gaps Will Cost Billions
Uhuru Kenyatta welcomes delegates at the Summit’s opening. @Nairobi Summit

One recent study, discussed at the conference, suggests that an estimated at US $264 billion will be needed over the next decade to achieve universal access to modern family planning, end preventable maternal deaths, and end harmful practices such as female genital mutilation and child marriage.

But only US$42 billion in development assistance is currently targeted to those aims, according to the study, a joint project of the UNFPA and John Hopkins University in collaboration with Victoria University, the University of Washington and Avenir Health. So an additional US$222 billion would be needed in the next decade to close the gaps, whether in form of direct investment, private spending or domestic allocations.

At the conference, however, some new financial commitments were also made. Private sectors organizations including the Ford Foundation, Johnson & Johnson, Philips and World Vision, among others, pledged to mobilise US$8 million. A press release said that the funds would support achievement of the triple goals for 2030 of zero preventable maternal deaths, zero unmet need for family planning, and zero gender-based violence and harmful practices. Groups ranging from health care and technology companies to private foundation, International NGOs and sports have also stepped forward with new commitments.

“We know how much and where we need to invest. These figures are a drop in the ocean compared to dividends,” Dr. Kanem. “Smart and affordable investments will transform the lives of women and girls.”

UNFPA statistics indicate that an estimated 232 million women want to prevent pregnancy but are not using modern contraception. More than 800 women die from preventable causes during pregnancy and childbirth each day, and 33,000 girls are forced into marriage. Still every year, more than 4 million girls are subjected to female genital mutilation.

“As critical accelerators for the Sustainable Development Goals, the outcomes of ICPD must be carried forward. The success of the global agenda for sustainable development, our common framework for the people, planet, prosperity, peace and partnership, depends on it,” said United Nations Deputy Secretary-General Amina Mohammed, speaking at the Summit’s opening ceremony.

Proponents say that the summit will re-energise the global community, breathe new life into the ICPD agenda and sustain and amplify gains made since 1994. It will be a springboard for governments and other organizations to announce voluntary, global commitments – including financial ones-that will accelerate progress. “The Nairobi Statement is not a government statement, but a stakeholders’ statement,” said Dr. Kanem.

 

Conference Opponents Stage Parallel Event

But on Monday, the day before the Nairobi Summit opened, groups opposed to the meeting’s aims and themes demonstrated in the streets outside of the venue. As the conference opened Monday, the protesters held their own, parallel meeting at a Catholic church next door. Under the banner of what they called a Pro-family Caucus, they cautioned governments against making legal commitments to the Nairobi outcome document, and to rather reaffirm their commitment to the ICPD Cairo Programme of Action, which they said had a stronger “pro-life and pro-family” platform.

The groups opposing the current conference say it has been organized without the authority of the United Nations General Assembly. They add that it has ignored the traditional consensus-building approach of the UN, in favor of imposing a “liberal sexualization” agenda. They have also charged that the summit deliberately excluded civil society groups or members of national delegations who support their positions.

“The organizers of the Nairobi Summit….believe in anti-population and pro-abortion ideology. They have openly stated their intention to use the Nairobi Summit to advance their ideology internationally and apply pressure on pro-family groups and countries that are pushing back against the SRHR [sexual and reproductive health rights] agenda,” said the groups in a statement.

Anti-abortion protestors march in the street at the start of the ICDPD25. Photo: Fredrick Nzwili

Image Credits: @NairobiSummit , @Atayeshe.

The World Health Organization has “pre-qualified” a new Ebola vaccine in record time, just a day after the vaccine, Ervebo, received European regulatory approval.

“This is the fastest vaccine prequalification process ever conducted by WHO,” said the organization in press release Tuesday evening. The WHO approval was described as a “critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, called it “a historic step towards ensuring the people who most need it are able to access this life-saving vaccine. Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”

The WHO move followed Monday’s news of the European Commission (EC) decision to grant conditional marketing authorisation to the pharmaceutical company Merck Sharp & Dohme (Merck) for the first-ever vaccine against the deadly Ebola virus. The announcement drew cheers in the global health community from boardrooms to laboratories where researchers had worked for years to create a safe vaccine for the virus that kills two-thirds of its victims. The EC move followed a recommendation from the European Medicines Agency (EMA). 

Monday’s approval of the new vaccine was not necessarily a big surprise. The Merck formulation has already proven to be highly effective under a special compassionate use protocol, which has seen more than 250 000 people immunized during the current Democratic Republic of Congo (DRC) outbreak. As such, it has has been operationally deployed for months as a key part of a “ring strategy” fighting the DRC outbreak, and used for immunizing health workers as well as people who were identified as known contacts of those infected with Ebola.

However, the formal EC decision still represented a huge milestone for a first-ever vaccine to protect against one of the world’s most deadly viruses.  Observers said it should ultimately help speed up production and expand use of the vaccine, which has been subject to supply bottlenecks and shortages at times.

WHO’s Pre-Qualification process or “Pre-Qual” as it is widely known, is a sign-off on the vaccine’s quality, safety and efficiency data, which will help get the product into the field more quickly – expediting national regulatory approvals and paving the way for countries to procure the vaccine from donor-supported programmes at preferred prices. 

Seth Berkley, head of Gavi, The Vaccine Initiative, said in a tweet that the Gavi board would also vote on 5 December on a recommendation to “open a window” of support for uptake of “outbreak and preventive vaccines”, such as the Ebola formulation.  The proposal calls for creating a long-term Gavi Ebola vaccine programme including creation of a global Ebola vaccine stockpile, enabling countries to access and rapidly deploy Ebola vaccines in response to outbreaks, Gavi said in a press statement. On top of the stockpile, the Board “will also consider, if recommended, future support for preventive vaccination of high-risk groups outside of an outbreak such as healthcare workers in countries classified as being at high risk.”

Wellcome Trust Head of Vaccines, Charlie Weller, said in a statement: “The Merck Ebola vaccine has already saved countless lives and been key in preventing the ongoing outbreak in the DRC spiralling into a repeat of the 2014-16 epidemic, where 11,000 people died.

“Now it has market authorisation it will be much easier to provide access to the vaccine for those who need it most. It’s been a long journey and made possible by a truly global collaborative effort of researchers, governments, NGOs, companies and funders. Wellcome is very proud to have been among those who have played a part. We commend Merck for their commitment to developing this vaccine. But we should all pay tribute to the brave healthcare workers who have provided the best possible care in conducting the trials, as well as the leadership in the DRC, for this vital research.”

Although the vaccine’s rights are now held by Merck (MSD), in fact, scores of scientists in universities and research institutions across North America, Europe, and Africa contributed to the path-finding research that led to the milestone breakthrough, noted STAT News. It cited John Rose, a scientist at Yale University who developed the vaccine’s biological “delivery system” – a genetically modified vesicular stomatitis virus (VSV) that infects livestock but doesn’t harm people, and could safely carry an Ebola protein into the immune system. “It’s thrilling to see the first licensing of a VSV-based vaccine vector system for use in humans,” Rose was quoted by STAT as saying. “Numerous scientists worked for many years in my laboratory at Yale to develop this potent vaccine platform.”

The European Commission decision on Ervebo also follows on the recent announcement of the launch of a clinical trial for a second Ebola vaccine regimen developed by Johnson & Johnson (Ad26.ZEBOV, MVA-BN-Filo), now getting underway in the DRC, with the support of the European Union’s Horizon 2020 research programme. Unlike the Merck vaccine, the J&J vaccine requires two injections a number of weeks apart to be effective. But it may potentially protect people against multiple strains of the Ebola virus which tend to circulate in endemic areas – while the Merck vaccine only protects against the  Zaire Ebola virus species that has been the cause of the recent large DRC and West African outbreaks. DRC health authorities say the second vaccine will not be tested in the DRC outbreak’s hotspots, but rather in more peripheral areas, which could still be at risk now or in the future.

The final approval of the Merck formulation, and test deployment of the J&J vaccine, come just as the current Ebola outbreak seems to be finally winding down after raging in eastern DRC for over a year.  Over the past month, there have been about 19 reported new cases a week, down from a peak of 126 cases a week in April.  However the scattered, rural locations of the new infections continues to confound efforts to entirely stamp out the outbreak.  Sporadic violence against health care workers, and the recent murder of a radio journalist underline the continued resistance that health teams still face to winning broad community acceptance in some areas, for effective Ebola control measures, such as the reporting of new infections to Ebola Treatment Centers, as well as the safe burial of Ebola victims.

Vaccine Development Pathway 

In terms of Ervebo, the first clinical trial results of the vaccine (VSV-ZEBOV) in December 2016 showed it provided a high level of protection against the so called Zaire species of Ebola when it was first deployed at the end of the 2014-2016 West African outbreak, which had raged across Liberia, Sierra Leone and elsewhere. Expedited research on the vaccine was funded by Wellcome, DFID and the Norwegian Government among others. The vaccine was thus stockpiled and somewhat more readily available for use in the current DRC outbreak.

“The global community showed the power of working together during the West African Ebola epidemic. Continuing to do so could be key to improving our future epidemic preparedness,” said Weller, outlining the story of the vaccine’s development in a blog, published on the Wellcome website.

“The first research [in July 2015] showing that VSV-ZEBOV vaccine could help protect against Ebola brought sighs of relief. It was an incredible and humbling achievement that had only been possible due to the global collaboration of researchers, NGOs, governments, industry and funders – all working towards a unified goal.

“It suggested that a single injection of VSV-ZEBOV might be highly effective in preventing people from contracting Ebola. …The VSV-ZEBOV news was positive for two reasons. Not only did this vaccine candidate appear to protect against contracting the Zaire strain of Ebola, but it had only taken about eight months to get to this point, rather than many years.

The West African Ebola outbreak killed over 11000 people as well as devastating economies across the region. During the current outbreak in DRC, a total of 3285 cases of confirmed and probable infections had been reported as of 5 November.  Some 2191 people have died since the DRC outbreak began in August 2018, for a case fatality rate of 67%.

 

Image Credits: WHO.

With rates of self-harm, suicide and anxiety among children and young people growing around the world, UNICEF and the World Health Organization hosted the first ever “Leading Minds” Conference to tackle adolescent mental health on November 7-9. The forum highlighted the growing recognition of mental health as a global health problem, and follows moves made earlier this year by WHO to scale up social media campaigns for suicide prevention and implement a new Special Initiative for Mental Health.

“Around the world, 1 in 5 children and adolescents live with a mental health condition, such as depression or anxiety. Children living in poverty, or exposed to war, violence at home, or other difficult life situations, are particularly vulnerable. Very few of these young people have access to the [mental health] services they need,” said Dr Tedros Adhonym Ghebreyesus, director-general of the WHO.

“We need to break the silence and eliminate stigma. We need to find better ways to reach young people, through their families, peers, schools and online channels, and help them thrive.”

The first ever such forum co-hosted by UNICEF’s research center Innocenti and WHO in Florence, Italy brought together a variety of stakeholders from different sectors to develop recommended actions to tackle mental health in young people. The by-invitation only forum featured experts such as the Minister of Health of Kazakhstan, who discussed how their country mainstreamed adolescent mental health care into the education and health systems.

Experts at the conference noted the importance of shedding light on adolescent mental health as a particularly neglected area in the mental health space.

“Total development spending and government spending in mental health care make up less than 1% of overall health spending. And less than 1% of that amount is spent on children and young people,” Dr. Vikram Patel, a professor and adolescent health researcher at Harvard Medical School, pointed out in a video from UNICEF Innocenti.

He noted that adolescent mental health is still an area where researchers know very little. This is mostly because most research in mental health has been conducted on adult mental disorders, and mental health problems in young people “don’t fit neatly into these sorts of biomedical activities.”

Despite the lack of knowledge, investing in young people’s mental health is both a “moral and practical, economic” imperative, said Henrietta Fore, executive director of UNICEF, in her opening statement. Since half of all lifetime mental health disorders manifest before the age of 14, early detection, prevention, treatment and rehabilitation is key to “avoid further social and health care costs down the road,” she argued.

Dr. Tedros agreed, calling on all countries to invest in adolescent mental health as part of their efforts to expand Universal Health Coverage.

“After all,” he said, “There is no health without mental health.”

Image Credits: Twitter: @WHO.

MMV CEO David Reddy talks about the steps MMV is taking to support a new generation of malaria research leadership, promote more gender-sensitive malaria treatment and fast-track innovation on new malaria combination therapies. This follows a string of MMV successes over the past two decades in fostering new paediatric malaria treatments, new combination therapies to fight drug resistance and a breakthrough single-dose treatment, tafenoquine, for the relapsing form of malaria.

Health Policy Watch: You are celebrating the 20th anniversary of MMV’s creation. It was also one of the first non-profit “product development partnerships (PDP)” to be created, involving both industry and public sector actors in malaria R&D. How did MMV come about, and what gap has it filled in the R&D landscape?

David Reddy: MMV was formed in 1999, out of a WHA discussion with African leaders who were worried that there was more parasite resistance developing [to existing malaria drugs] and not enough R&D being done on new treatments, effectively there was a market failure.

It came out of the forward-thinking people in Industry and WHO, and incubated at the TDR, the Special Programme for Research and Training in Tropical Diseases.

Today we have a broad partner network, including some 26 pharma partners, both innovators and generic producers, as well as research and academic institutions, governments, international organizations, NGOs and non-profits, and clinical trial centres in endemic countries.

For the past two decades, MMV has been leading the development of new antimalarial treatments, supporting expansion of R&D capacity in malaria-endemic countries, and working to ensure access to antimalarial treatment by the world’s most neglected populations.

HP-Watch: We have heard you recently speak about how MMV had its roots in industry, while Drugs for Neglected Disease Initiative DNDi), had its roots in civil society activism – but you both have gotten to a similar place in your development. Can you talk a little more about that?

Reddy: Well, I compare it to the blue whale and the whale shark.  On the evolutionary tree, DNDI and MMV started from different places, but we are addressing the same underlying issues in the drug development ecosystem – market failure. In addition, we at MMV, we focus solely on malaria whereas DNDi’s remit is wider in terms of neglected tropical diseases.

Because of where we came from, we started from a strong R&D base; there were a lot of people from industry who became part of MMV.  So, I think we were positioned very well in terms of being able to get industry to contribute to the model.  Additionally, I have led teams [while at Roche] that had developed drugs with regulators, so I also know that mindset. And in fact, the regulators are quite agnostic about whether the innovation comes from industry or a non-profit group – the same rules apply.

HP-Watch: There has been a lot of discussion recently about the importance of insuring for wide access to treatments up front. When MMV engages with the private sector or others. What’s MMV’s approach on that, and how is it similar or different to others?

Reddy: In every agreement we have with our partners, we build in access and affordability clauses.  Those include two elements: a commitment to make the drug available and affordable in malaria-endemic countries.  We generally define what that means and in the context of affordability we have enforcement clauses, as well. If a partner doesn’t live up to those obligations, we can take action, such as moving manufacturing capacity across to another partner.

HP-Watch: Is there a motive for pharma to participate if the costs are kept low?

Reddy: Because of the sheer volume of the malaria drugs that need to be provided, [there is still an incentive]. It is a real challenge for other disease areas, where the populations are smaller. For some of our partners, the motive is corporate social responsibility. Others take a no-profit, no loss approach. Incentives such as the US FDA Priority Review Voucher programme can be important.  A partner can use a voucher (awarded upon approval of a new neglected disease treatment to get a rapid approval of another drug in a profitable disease area, where a six-month time to market advantage is worth a considerable amount of money.  And once the vouchers have been issued, they can also be transferred and sold. These kinds of benefits do help tip the balance of the pharma companies participating in this area.

HP-Watch:  Can you briefly summarize the 3-4 biggest breakthroughs you have experienced in drug development – up to the recent approval of the new drug tafenoquine – and their meaning for public health?

A health worker dispenses a child-friendly formulation of Coartem®, MMV’s first paediatric malaria treatment.

The first breakthrough was the product we co-developed with Novartis, that was a child-friendly version of their antimalarial drug, Coartem®, [the first artemisinin-combination therapy]. In less than ten years since launch, some 385 million courses of that treatment have been delivered.  This is a key success since most people who die from malaria are children under 5 years of age. And yet children are among the last to get [paediatric formulations of] medicines [due to the sensitivity of clinical trials involving children]. So, this was really important.”

Pyramax® (pyronaridine-artesunate), is another ACT – based on the drug pyrimidine, that has shown some nice activity in areas where resistance has been seen.

Testing for malaria (P. vivax) parasites in Brazil, the first malaria-endemic country to approve the first GSK and MMV co-developed treatment for relapsing malaria.

This is a particularly important development programme because we are working with a generic company, Shin Poong in South Korea, and they formed a joint team with us.  We were able to bring our knowledge of drug development and the malaria space to them and help bridge the gap between generic companies and innovators. So, it was a capacity development journey for them and for us it was useful in getting the product on the market.

Then, just last year, tafenoquine, which was developed in partnership with GSK and is a single dose cure for the relapsing form of malaria (caused by the Plasmodium vivax parasite), which in some patients can replace 14 days of treatment with the currently used drug. Tafenoquine was approved by the US FDA and Australian TGA. It has also just been approved by the Brazilian regulatory authorities.

 

A child receives injectable artesunate for severe malaria, a formulation that MMV is helping generic manufacturers produce.

In addition, we are supporting generic manufacturers to produce quality-assured variations of rectal artesunate and injectable artesunate, [for immediate treatment of severe malaria episodes]. This was massively important in terms of getting these products onto the WHO Pre-Qualification list, [which undertakes a stringent review and can be a pathway for approval by national regulatory agencies]. For the injectables alone, some 144 million vials have been shipped since 2011, and we estimate that has saved 950,000 more lives in comparison to the alternative treatment, injectable quinine – if people were even to receive that at all. For the suppositories, some 3.2 million have been shipped since 2017, and we estimate about 300,000 lives have been saved.

HP-Watch: What about malaria resistance… how serious a threat is that, where and what is MMV doing about it?

Reddy: There is resistance being seen with some of the ACTs – current first-line treatment for uncomplicated malaria. o\On that basis, we are developing, with Novartis, a new combination of novel compound ganaplacide with a new formulation lumefantrine. This is a non-artemisinin-based combination, which is what we need to be looking for, with a new mechanism of action against resistant parasite forms. It is in Phase 2b studies, and we are hoping it could be a one- or two-day therapy. That would provide a big benefit, in terms of its utility because one of the big challenges that we have seen with the ACTs [which have a 3-dose regimen] is that while people will take the first and second dose, there is a tendency for people to hold back on that last day of dosing, if they are feeling better, thinking that they can save the pill until the next child gets sick. And that fosters resistance.

Resistance is something that needs to be taken really, really seriously, we have seen it in each of the malaria drugs that have been developed, which is why using them in combination is so important.

So, we are trying to pursue an approach where multiple approaches for first-line therapy are available in every country, keeps the pressure on the parasite. Secondly, we are trying to develop new combinations with new mechanisms of action, like the Novartis project I just mentioned. Towards this end, there were 5 biological targets – ways we could hit the parasite – 20 years ago. Today there are 25 targets, and this can give rise to entirely new drugs; a number of them are already in clinical development.

Malaria parasite (blue-left) attaches to a human red blood cell (red-right)

We see the parasites being resistant to the drugs, we see the mosquitoes becoming resistant to the insecticides. We even see the parasites developing a form of resistance to the rapid tests that we use to identify them. In some of the tests, they had worked out a way to escape the test, by deleting a part of their genome that gave rise to a protein used by the rapid test to detect them. This multi-layered counter-offensive is something as a biologist that I have never seen.

The threat of resistance is compounded by other regional or global changes.  For instance, with climate change you get flooding, destruction of infrastructure that reverses the development progress that has been made. The other challenge is political instability, you can see that in the resurgence of malaria in Venezuela.

HP-Watch: The theme of malaria “eradication” has been much in the news, with some agencies saying it’s feasible and WHO saying that the elimination agenda first must get back on track. What’s your view?

Reddy: There were two reports on this topic that were launched a few months ago, one was by the Lancet Commission and one was by the WHO Strategic Advisory Group on Malaria Eradication (SAGEme).  Both effectively came to the same conclusion, which was that eradication should be our objective.  The WHO report [also] said that there is no biological impediment for why it cannot be achieved. But we will need new interventions.

I believe in the feasibility of eradication. What it requires is systematic elimination from countries and regions, as we have done it in Europe and North America. [It also requires a change in mindset], because many people have this inherent belief that the countries in Africa are locked into malaria.

Hans Rosling, in his book Factfulness said that countries in Africa have developed beyond most people’s understanding, at a strong pace. African countries are showing strong ownership of the concept of eradication and they are putting resources behind it. We have seen enormous progress in pushing back malaria, and a number of countries are on the cusp of elimination of malaria [as a public health risk]. But in other countries, we need to do more, including getting more real time data on what is working and what is not.  Groups such as USAID Presidents Malaria Initiative, the Global Fund and the Gates Foundation are really putting processes in in place to get better real time access to data that is needed. And part of it is up to us, to bring a new generation of medicines forward for prevention and treatment. We have made enormous progress; we have entirely new ways of attacking the parasite. Now it’s a matter of getting innovations through development and into the hands of clinics and patients.

HP-Watch: Some critics have accused the health sector of abandoning vector control, including environmentally-friendly measures such as better management of water resources and housing (e.g. screening) as modes of “treatment”, which can also reduce reliance on chemicals, and therefor vector resistance to chemical tools.

Reddy: I think vector control is being addressed from a different angle, the developmental angle.  We do see significant developmental progress and there will be a positive collateral effect on malaria. The Zero Malaria Starts with Me [a continent-wide campaign to eliminate malaria], begun by Senegal, is about communities; it is ensuring that trash is cleaned up, etc. I think the zero malaria starts with me is a good starting point.  But I agree that if we want to address malaria and really beat it, it is a belt and braces approach, we shouldn’t be throwing out any interventions without a thorough assessment.

HP-Watch: What about R&D costs, a subject in the news recently.  Do you have any assessment of the costs to bring a new or adapted drug to market?

MMV and partners have implemented a series of platforms to gather data to feed into a tool to allow unbiased prioritization of optimal drug combinations for further research.

Reddy: The overall costs for development of a malaria drug is about $US 100 million.  The fully loaded costs are probably in the region of $US 200 million. If we pay a dollar, the pharma pays a dollar plus in-kind contribution such as their facilities.  This is not including drug attrition. But since we have a strong system of pre-clinical assays, we can kill drugs pretty early.

Today, we have a strong network of SCID (severe combined immune deficiency) mice assays that allow you to test drug or drug combinations very quickly. [at a later stage] We can also run tests on healthy human volunteers infected with very small amounts of malaria parasites before it becomes clinical, you can treat them [with the experimental drug], and then you can treat them with the standard drugs, so that in a very, very controlled setting you can explore your drugs, are they going to work, and the likely dose you can use with patients. This keeps costs down and speeds things up.

HP-Watch: What challenges lie ahead, and do you see MMV continuing to address malaria only, or could there be other targets for your work?

Reddy: I think there is a real acknowledgement that it is not the current generation of leadership that will finish this job, and that includes me.  We need to be looking for that next generation of leadership and scientists. Much of that leadership is going to be coming from the malaria endemic countries.  So, our work on empowering needs to be rooted in the Malaria endemic countries.

MMV will be focusing on developing better treatments for pregnant women in the coming years

We will be looking more closely at groups such as pregnant women, who are disproportionately affected by malaria.  Yet in drug development programmes, pregnant women are classed as a vulnerable population, and therefore [in the traditional R&D mindset] you protect them from new drugs. [But that leads to us not having adequate drugs for women in pregnancy]. We are all realizing that we have been thinking about this in completely the wrong way, and so we need to see how we can get them included in studies so that they can benefit from new drugs earlier. We need to create a stronger programmatic stream [around malaria in women/pregnancy] if we are going to change things and move towards more equitable access.

Finally, new malaria combination drugs are going to become more and more important in order to avoid resistance.  So, we are launching a “malaria drug development catalyst” [initiative].  This is a unique way of bringing partners together at an earlier stage of development, to look at what drugs can be combined.

With out partners, we have already developed the technical tools, such as mouse assays and human volunteer studies, that allow us to perform tests in a consistent way. All partners can access the molecules, and the molecules can be put through the same assays, so that you can do an apples to apples comparison and see which molecules work best.

As with the assays, we want to create a common way of doing assessments and common agreements with the different companies and partners, so that it is easier for them to work with us and together. This is becoming very important now because we have a number of new drugs coming up through the pipeline. So, it is one of those perfect moments in time when everything comes together, and this is a way of formalizing and accelerating things.

 

This story is part of a series supported by MMV on malaria innovation.___________________________________

About David Reddy: Prior to joining MMV, in 2010, Reddy was a Vice President at Roche Pharmaceuticals, in Basel, Switzerland. With 20 years of management experience in the healthcare industry includes: successful leadership of drug development teams; licensing and alliance management; market analytics and business planning; product and disease area management; and interfacing with Governments, NGOs and patient advocacy groups in priority disease areas including HIV/AIDS and pandemic influenza. He has a doctorate in Cellular and Molecular Biology from the University of Auckland, New Zealand and completed a Post-Doctoral fellowship in molecular neurobiology at the Friedrich-Miescher Institute in Basel Switzerland.

 

Image Credits: Anna Wang/MMV, Novartis, Ben Moldenhauer/MMV, NIAID, NIH, MMV, Elizabeth Poll/MMV.

The number of Ebola cases per week has plateaued at a low, but consistent, count of 19 per week in the past 21 days, but the violent death of a radio journalist who had won acclaim for his Ebola outreach work has responders remaining vigilant. One Ebola case was also detected this week at a newly opened point-of-entry between the Democratic Republic of the Congo and Uganda, highlighting a continued risk of regional spread.

The attack in Ituri province on Papy Mumbere Mahamba, just after he had completed a broadcast for a community radio station in Lwemba, left him mortally wounded, his spouse critically injured with multiple wounds, and his house in razed to the ground according to a statement released by the DRC Ministry of Health and the WHO African Regional Office as well as other eyewitness and media accounts. While the exact motives for Mahamba’s murder remained unclear, community members said he was a host for a popular local radio show that had been a vehicle for raising awareness about Ebola.

“We are saddened and deeply shocked to hear about the death of community health worker and journalist, Papy Mumbere Mahamba who was helping tackle Ebola in the DRC. Our condolences to his family and loved ones. Humanitarians are not a target,” said Jamie LeSueur, emergency operations manager for the International Federation of the Red Cross in Africa and head of its DRC Ebola operation.

Since January of this year, WHO has documented more than 300 attacks on health workers, which have resulted in at least 6 deaths and 70 injuries of staff and patients. The Lwemba Health Area has been particularly volatile, with Ebola response activities previously suspended there for more than two weeks in September due to violence in response to the death of a local healthcare worker by Ebola.

Both WHO and the MoH condemned the attack on Mahamba in a statement, saying, “Any act of violence against individuals involved with the response is unacceptable and compromises the ability of health workers to provide assistance to communities impacted by the devastating effects of Ebola.”

Local journalists from Butembo and Lwemba (left) in a press conference with David Gressly (right) days after the death of their colleague, Papy Mumbere Mahamba.

UNESCO, which tracks murders of journalists, also condemned the brutal killing of the local radio host, with Director-General Audrey Azoulay calling it a “tragic illustration of the cost to society that violence against the media represents.”

Local news outlets have been important communication channels in the outbreak response, leveraging their reach to spread key messages that sensitize communities to Ebola response activities. Just days after Mahamba’s death, local journalists were back at work, telling UN Emergency Ebola Coordinator at a press conference that “the best way to pay tribute to our Papy Mahamba is to continue his struggle.”

As insecurity continues to plague the Ebola response as the level of access to affected communities in rural, hard-to-reach areas continues to fluctuate, WHO recommends interpreting the low weekly case incidence with caution.

Some 54 confirmed cases of Ebola Virus Disease (EVD) were reported from North Kivu and Ituri provinces over the past 21 days, leading to an average of 19 cases per week, although case counts fluctuate daily. Some 31% of cases originated from Mabalako health zone and 39% of the cases were located in Mandima health zone, with 83% of all cases traceable back to Mandima’s Biakato Mines Health Area. The remaining 10 cases were linked to known contacts in the other health areas.

With insecurity plaguing the response and increased movement between the health zones, responders are concerned that the virus could be reintroduced into previously cleared areas or brought to new, unaffected regions. Approximately half of the cases reported in the past 21 days were located outside of the health zone where they had gotten infected.

The risk of the outbreak spilling over into other countries was a primary reason WHO Director-General Dr. Tedros Adhomyn Ghebreyesus decided last month to keep the DRC outbreak designated a “public health emergency of international concern.” A WHO analysis of population movement shows that people continue to travel from outbreak hotspots such as Mambasa DRC over the border into Uganda. An Ebola case was identified while attempting to cross a newly opened port-of-entry into Uganda. Since a regional Ebola preparedness plan was announced in September, new reinforcement activities have been conducted to prevent the outbreak from spreading across borders, including scaling up EVD testing capabilities near the border on the DRC side.

 

Image Credits: Twitter: @davidgressly.

In a move fraught with international political overtones, Italy’s new Minister of Health is moving to replace the Director General of the Italian Drug Agency (AIFA), Dr Luca Li Bassi, who was the key architect of the May World Health Assembly (WHA) resolution supporting greater price transparency in medicines markets, Health Policy Watch has learned.

The potential replacement of Li Bassi, a seasoned career public health professional, comes only a year after he was selected to fill the top civil service position at AIFA in an international, juried competition.

Luca Li Bassi holding Italy’s placard at the 72nd World Health Assembly with other lead co-sponsors of the WHA Transparency Resolution.

The move against Li Bassi has stirred protest among civil society drug access groups, which this week sent an open letter to the new Italian Health Minister, Dr Roberto Speranza asking him to reconsider the move.

The petition, signed by 21 organizations and about two dozen leading medicines access advocates, follows the publication last week on Italy’s Ministry of Health’s website of a call for applications for the position of director-general of AIFA (Agenzia Italiana del Farmaco).

The advertisement for a replacement for Li Bassi follows a September reshuffle in the Italian government whereby the left-wing Italian Article One party, in which Speranza is a leader, joined the Five Star party in the national government. As a reward, Article One received the health portfolio and Speranza was named as Health Minister. That portfolio had previously been held by Five Star Party member Giulia Grillo, who had taken over the job as Health Minister in 2018 under a Five Star party platform pledged to lower Italy’s soaring drug prices.

Grillo’s appointment of Li Bassi in October 2018, shortly after being appointed was a first step in that direction – and it set something of a precedent in Italy’s highly politicized government circles – due to the rigorous candidate selection process, overseen by an international panel of three public health experts. The process was even the focus of a Lancet opinion piece co-authored by Grillo, who admitted it was “quite unusual for Italy” but cited it as evidence that she and her government were committed to making policy choices anchored in “scientific-based methods”.

Luca Li Bassi in a recent interview on Italian national TV, Rai3

“We will apply the same methods, based on international reputation and meritocracy, that have worked well for AIFA and CSS for all future decisions concerning the leadership roles in the health system,” Grillo declared in the Lancet article published in August 2019.  Only a month later, following the government reshuffle, Grillo was out of a job.

In the intervening year that Li Bassi has held the post, he has rapidly made a name for Italy and himself in global health circles – initiating the unprecedented WHA proposal on the drug transparency resolution in February 2018, and then steering it to approval in the May WHA.  Li Bassi was widely credited for helping member states reach “common ground” in what  Angola’s Health Minister Silvia Paula Valentim Lutucuta described as “one of the most complex and polarising issues in 21st century global health.” Lutucuta chaired the WHA Committee A, which oversaw the WHA negotiations on the price transparency resolution.

But following September’s replacement of Grillo by Speranza in the government reshuffle, Li Bassi’s days now may be numbered, his supporters fear. Ironically, Speranza comes from an ardently left-wing party that would presumably be sympathetic to the price transparency agenda.  But that, informed observers remark, has apparently not made him immune to the time-worn traditions of patronage politics, including political appointments for key civil service posts.

Public notice for expressions of interest for the post of Director General of the Italian Drug Agency – AIFA
Protest By Civil Society Leaders Over Italian Move

In the civil society letter of protest to Speranza over Li Bassi’s possible replacement, the AIFA director was lauded for his role in “overcoming enormous opposition from vested interests” to see the May WHA resolution on “Improving the transparency of markets for medicines, vaccines, and other health products” approved.

“It is difficult to convey how great a challenge it was to get the WHA to consider, let alone approve a resolution dealing with transparency, given the longstanding drift towards greater secrecy and less transparency in every aspect of the development and pricing of medicines,” the signatories said.

“His expertise, commitment, compassion, diplomatic skills and tirelessness were critical to the adoption of the resolution,” the signatories noted. “It is very rare to see a senior government official do so much in such a short time to raise awareness across the global community of the need to change course on issues fundamental to – and perceived as contrary to –  the interests of the largest pharmaceutical companies in the world.

The groups also pointed to Li Bassi’s previous record with other UN agencies, non-profits and global health groups, such as the Global Fund to Fight AIDS, TB and Malaria, where he helped pioneer a transparent drug procurement system.

“Many of us worked with Dr Li Bassi during his earlier efforts to provide access to affordable drugs for the treatment of HIV in developing countries. His work in establishing the Global Price Reporting Mechanism (GPRM) at The Global Fund has been recognised as an example of the value and feasibility of implementing transparency policies in the pharmaceutical sector,” the letter stated.

Under Li Bassi, AIFA had been expected to help lead a group of technical experts from the so-called Valletta Group of countries to take forward some of the key outcomes of the WHA drug transparency resolution into a dialogue with the European Commission’s Employment, Social Policy, Health and Consumer Affairs Council. The aim was to develop framework legislation for European countries to voluntarily band together share price data and bargain collectively with industry on pharma prices.

Should Li Bassi be moved out and a leadership vacuum created, the plans of the Valletta group may be delayed, observers have said.

Leadership on CAR-T Therapies and & Locally-supported Research

In addition to the work pioneering the WHA drug transparency resolution, Li Bassi has also been setting precedents in Italy on the support and promotion of local cutting-edge research, leading to more affordable, cell and gene therapies, colleagues told Health Policy Watch.

He persuaded the Ministry of Health to establish a national public project, investing 60 million Euros to create Italian hospital-based production facilities for CAR-T cells.  The initiative should help keep the cost of the therapies down as use of the new gene therapies to fight cancer expands.

Li Bassi also created an innovative initiative with the pharmaceutical companies Gilead and Novartis, which hold patents on CART-T treatments for lymphoma and leukaemia, to reimburse the companies in accordance with the survival rates of the patients who get the therapies – keeping treatment costs down while incentivizing therapies that prolong life expectancy.   Through another initiative, AIFA and the Ministry are investing public funds in home-grown Italian research into CART-T therapies for other conditions, particularly for children.

“In addition to his work on transparency, Dr Li Bassi is one of the leading exponents of strategies to make new technologies, such as cell and gene therapies, more affordable,” notes the civil society letter to the minister. ”To this end, his effort to empower Italian research institutions to develop new CAR-T therapies within the public health system, is extremely important not only for Italy, but also as a progressive example for other countries.

“He has reached out to the leading scientific, technical and legal experts to advance this work, and has done so at a very critical moment, given the emerging regulatory, legal and reimbursement regimes that are only now being tested. Italy is one of the few countries to undertake pro-active assessments of possible ways forward in these areas, and this is largely the result of Dr Li Bassi’s willingness to challenge the status quo and to prioritize the public interest.”

 

Beatrice Marone contributed to this article.

Image Credits: Rai3, HP-Watch/E Fletcher, Italian Ministry of Health.

As a cholera outbreak inches closer to Sudan’s capital city of Khartoum, the Sudanese Ministry of Health and the World Health Organization are scaling up the response. Two cholera cases were confirmed in the district of Khartoum State on October 19. As of Monday, November 3, the Ministry of Health had reported 332  suspected cases of cholera since 28 August when the first case was detected.

While the recent cases have been mostly concentrated in Blue Nile and Sennar States, officials are concerned that if the current outbreak of the often fatal diarrhoeal disease spreads more widely in Khartoum State and from there, to the very densely populated, urban areas of the capital city, it would have an even more serious impact, particularly on children.

“The risk of cholera spreading is very real. If not properly managed, this could have potentially serious consequences. More than eight million people live in Khartoum State, where the public health system is impacted by the economic crisis, recent flooding, and ongoing outbreaks of infectious diseases,” said Naeema Al Gasseer, WHO Representative in Sudan, in a press release.

A health worker monitors the cholera vaccination campaign in Sennar.

Together with the Ministry of Health, WHO has conducted initial risk mapping in Khartoum State to identify which areas are more likely to be at increased risk. This will allow for more informed planning to ensure that vulnerable areas, such as Sharq Elnil and Ombada localities, are better prepared to respond. Two cholera treatment centers are being set up in Ombada and Bahri localities. So far, WHO has delivered cholera medicines and supplies to treat 400 severely dehydrated patients, as well as 500 rapid diagnostic tests, which can be used for screening suspected cases in health facilities. Some 1.6 million people are also to be vaccinated in Blue Nile and Sennar States as part of the response.

Some 271 health staff and paramedics have been trained in cholera detection and management with support from Doctors Without Borders/Médecins Sans Frontières (MSF) and WHO. The Ministry of Health and WHO are working with more than 1700 male and female health promoters and volunteers to raise awareness of cholera, as well as provide education on hygiene practices and environmental health in communities affected or at risk.

“A key aspect of preventing and controlling cholera is how well at-risk communities are able to protect themselves by drinking safe water, properly handling food, avoiding defecation in open areas, hand-washing, and knowing what to do when they see the first signs of infection,” said Al Gasseer.

 

Image Credits: Twitter: @WHOSudan.

A coalition of over 40 personalities – from doctors and economists to actors and health access activists – released an open letter Tuesday calling on the French Prime Minister Edouard Philippe and the Minister of Health Agnès Buzyn to support a series of amendments to the French Social Security Budget Bill for 2020 providing for greater transparency around the selection and pricing of drugs purchased for the national health system. The bill, which provides the framework for public health system funding, will be going before the French Senate next week, and drug pricing amendments were previously blocked by the Minister of Health in a presentation of the bill to the National Assembly on October 24th.

“The government’s negative review of these amendments is incomprehensible and politically untenable,” states the petition. Noted French academics, doctors, and cultural figures such as composer Bertrand Burgalat; writer Edouard Louis; economist Thomas Piketty, anthropologist Didier Fassin; and Academy of Medicine member and medical school faculty Alfred Spira, have all signed on to the letter to the Minister of Health and the Prime Minister.

The strongly-worded statement goes on to call the rejection of the price transparency measures a “denial of the French commitment made to the World Health Organization,” referring to France’s vote in favor of the landmark price transparency resolution passed at the 72nd World Health Assembly in May. While political leaders in other European countries such as Malta and Italy have been pushing the transparency agenda, civil society actors such as l’Observatoire Transparence Médicaments (OTM) have been driving the conversation around pricing transparency in France.

The proposed amendments contained in Article 28 of the budget proposal, would provide for the systematic publication of data on prices paid by the public health system for bulk medicine purchases; more detailed patent information, as well as data on public contributions to R&D costs.  The amendments would also give the government more leeway to use the threat of “compulsory licensing” –  to produce a generic version of patented drugs – as a bargaining tool in negotiations with pharmaceutical suppliers, Pauline Londeix of OTM told Health Policy Watch. The amendments were proposed by OTM and presented by Members of Parliament of the left-wing “La France Insoumise” Party to the National Assembly two weeks ago – but were shot down at the first reading of the bill by the Minister of Health.

French Health Minister Agnès Buzyn at the National Assembly on October 24th

“We are all in favor, of course, of a very regular review of the price of medicines. This is a goal we share. But it seems to me that the method proposed to reach it does not correspond to the reality of the facts,” said Buzyn in her negative opinion of Article 28. Buzyn explained that she thought the proposed amendments, such as one clause that requires all drug prices to be reviewed at a minimum every 5 years, would actually “lead to deviant practices” and lengthen the time between price reductions for drugs.

Buzyn claimed that in more than “half the cases” CEPS, the body in charge of negotiating drug prices, actually renegotiates prices in more frequent intervals than 5 years.

Still, the Senate meeting next week will present another opportunity for the transparency amendments to be included in the final version of the budget bill.

There is “a possibility” that the transparency amendments will be accepted at that meeting, before the bill is sent back to the National Assembly for a second and final review by that legislative body before it is adopted, Londeix told Health Policy Watch. “We hope that the Senate will support [the amendments].”

Some 11,258 scientists from 153 countries have issued a sharp warning in the journal BioScience, about the climate emergency faced by the global community.

The scientists calls for “bold and drastic transformations” in six key areas to pull earth from the precipice of potentially catastrophic deterioration in basic life support systems. Their prescription includes: a rapid shift of economies from fossil fuels to renewables; reduced emissions of short-lived climate pollutants like methane and black carbon (soot) that could slow short-term warming trends “while saving millions of lives” from air pollution; restoration of degraded natural ecosystems from coral reefs to savannas; shifting to mostly plant-based foods; reduced over-consumption of materials and minerals; and stabilization of population growth with access to family planning services, progress in gender equity, and universal primary and secondary education including for girls and young women.

The article published on Monday, a month ahead of the 25th Climate Conference (COP 25) in Madrid, carries a particular note of urgency in light of the large number of signatures by scientists, who normally frame their views in cautious, incremental terms.

“Scientists have a moral obligation to clearly warn humanity of any catastrophic threat and to “tell it like it is.” On the basis of this obligation and the graphical indicators presented below, we declare, with more than 11,000 scientist signatories from around the world, clearly and unequivocally that planet Earth is facing a climate emergency,” states the article published on Tuesday.

Earth’s Vital Signs in Red Zone

The scientists note that average global temperature increases are alone insufficient to capture the dimensions of the problems faced. They point to a range of “concurrent trends in the vital signs of climatic impacts” that represent a “suite of graphical vital signs of climate change over the past 40 years”.

These include: continued increases in atmospheric CO2, concentrations; in greenhouse gas emissions (CO2, methane, and nitrous oxide); and a particularly ominous 2019 spike in CO2.

Monthly mean carbon dioxide measured at Mauna Loa Observatory, Hawaii. The carbon dioxide data ([black] curve), measured as the mole fraction in dry air, on Mauna Loa constitute the longest record of direct measurements of CO2 in the atmosphere. […] The [black line represents] the monthly mean values, centered on the middle of each month. The [red line represents] the same, after correction for the average seasonal cycle. The latter is determined as a moving average of SEVEN adjacent seasonal cycles centered on the month to be corrected, except for the first and last THREE and one-half years of the record, where the seasonal cycle has been averaged over the first and last SEVEN years, respectively. Source: https://www.esrl.noaa.gov/gmd/ccgg/trends/
In addition, global ice cover “has been rapidly disappearing, evidenced by declining trends in minimum summer Arctic sea ice, Greenland and Antarctic ice sheets, and glacier thickness worldwide. Ocean heat content, ocean acidity, sea level, area burned in the United States, and extreme weather and associated damage costs have all been trending upward… Climate change is predicted to greatly affect marine, freshwater, and terrestrial life, from plankton and corals to fishes and forests (IPCC 2018, 2019). These issues highlight the urgent need for action,” the scientists state.

“Profoundly troubling signs from human activities include sustained increases in both human and ruminant livestock populations, per capita meat production, world gross domestic product, global tree cover loss, fossil fuel consumption, the number of air passengers carried, carbon dioxide (CO2) emissions, and per capita CO2 emissions since 2000,” they add.  There are also positive trends, such as declines in global fertility rates, increased solar and wind power production, reduced forest loss in the Amazon, and fossil fuel divestment.  But renewable power production still lags far behind that of fossil fuels, and annual fossil fuel subsidies remained greater than US$400 billion in 2018.

“To secure a sustainable future, we must change how we live, in ways that improve the vital signs summarized by our graphs. Economic and population growth are among the most important drivers of increases in CO2 emissions from fossil fuel combustion (Pachauri et al. 2014, Bongaarts and O’Neill 2018); therefore, we need bold and drastic transformations regarding economic and population policies. We suggest six critical and interrelated steps (in no particular order) that governments, businesses, and the rest of humanity can take to lessen the worst effects of climate change. These are important steps but are not the only actions needed or possible,” the scientists add. Those include:

Energy

“The world must quickly implement massive energy efficiency and conservation practices and must replace fossil fuels with low-carbon renewables (figure 1h) and other cleaner sources of energy if safe for people and the environment. We should leave remaining stocks of fossil fuels in the ground (see the timelines in IPCC 2018) and should carefully pursue effective negative emissions using technology such as carbon extraction from the source and capture from the air and especially by enhancing natural systems (see “Nature” section). Wealthier countries need to support poorer nations in transitioning away from fossil fuels. We must swiftly eliminate subsidies for fossil fuels and use effective  and fair policies for steadily escalating carbon prices to restrain their use.”

Short-lived pollutants

“We need to promptly reduce the emissions of short-lived climate pollutants, including methane (figure 2b), black carbon (soot), and hydrofluorocarbons (HFCs). Doing this could slow climate feedback loops and potentially reduce the short-term warming trend by more than 50% over the next few decades while saving millions of lives and increasing crop yields due to reduced air pollution (Shindell et al. 2017). The 2016 Kigali amendment to phase down HFCs is welcomed.”

Nature

“We must protect and restore Earth’s ecosystems. Phytoplankton, coral reefs, forests, savannas, grasslands, wetlands, peatlands, soils, mangroves, and sea grasses contribute greatly to sequestration of atmospheric CO2. Marine and terrestrial plants, animals, and microorganisms play significant roles in carbon and nutrient cycling and storage. We need to quickly curtail habitat and biodiversity loss (figure 1f–1g), protecting the remaining primary and intact forests, especially those with high carbon stores and other forests with the capacity to rapidly sequester carbon (proforestation), while increasing reforestation and afforestation where appropriate at enormous scales. Although available land may be limiting in places, up to a third of emissions reductions needed by 2030 for the Paris agreement (less than 2°C) could be obtained with these natural climate solutions (Griscom et al. 2017).”

Food

“Eating mostly plant-based foods while reducing the global consumption of animal products (figure 1c–d), especially ruminant livestock (Ripple et al. 2014), can improve human health and significantly lower GHG emissions (including methane in the “Short-lived pollutants” step). Moreover, this will free up croplands for growing much-needed human plant food instead of livestock feed, while releasing some grazing land to support natural climate solutions (see “Nature” section). Cropping practices such as minimum tillage that increase soil carbon are vitally important. We need to drastically reduce the enormous amount of food waste around the world.”

Economy

“Excessive extraction of materials and overexploitation of ecosystems, driven by economic growth, must be quickly curtailed to maintain long-term sustainability of the biosphere. We need a carbon-free economy that explicitly addresses human dependence on the biosphere and policies that guide economic decisions accordingly. Our goals need to shift from GDP growth and the pursuit of affluence toward sustaining ecosystems and improving human well-being by prioritizing basic needs and reducing inequality.”

Population

“Still increasing by roughly 80 million people per year, or more than 200,000 per day (figure 1a–b), the world population must be stabilized—and, ideally, gradually reduced—within a framework that ensures social integrity. There are proven and effective policies that strengthen human rights while lowering fertility rates and lessening the impacts of population growth on GHG emissions and biodiversity loss. These policies make family-planning services available to all people, remove barriers to their access and achieve full gender equity, including primary and secondary education as a global norm for all, especially girls and young women (Bongaarts and O’Neill 2018).”

 

Image Credits: blog.oup.com, Bioscience.