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Teaching Big Pharma to share

This article is part of the Global Policy Lab: Decoding Cancer.

Researchers want to save the pharm..

This article is part of the Global Policy Lab: Decoding Cancer.

Researchers want to save the pharmaceutical industry time and money on clinical trials. But that means teaching companies to work together and convincing them to pool patient data, benefiting not just themselves but also their competitors.

Its not an easy sell.

“In the vast majority of cases, the company wants to be in control,” said Denis Lacombe, chief of the European Organisation for Research and Treatment of Cancer.

Lacombe is basically in a race against Big Pharma to build a public biological database before companies create their own private ones.

The stakes, for patients, are high.

Innovations in so-called precision medicine, in which treatments are tailored to individuals, has made patient data critically important. The more it is walled off in corporate troves, some cancer experts like Lacombe warn, the more the potential of using big data is undermined and the harder it becomes for patients to find relevant experimental treatments.

EORTCs SPECTA platform is a collection of genomic and other biological and clinical data. When a new treatment is available to be tested, the data can be searched to identify patients who could participate.

Thats something that will be increasingly important as personalized medicine drives pharmaceutical companies “to search for specific patients with specific [genetic] alterations,” Lacombe said.

That should be an opportunity for the pharma industry, said Lacombe. But it hasnt worked out that way.

The industrys been slow to engage with SPECTA. Lacombe is concerned that instead, companies are starting to collect peoples genomic data on their own, without having a particular treatment or trial in mind.

“There is a risk that the commercial sector will develop a … parallel route to access DNA,” he said. Its “suboptimal, if not unethical, that companies collect biological data and put it in a commercial silo.”

The EORTC isnt the only one trying to collect patient data.

A parallel effort with a more utopian vision is based in the neutral Alpine haven of Switzerland. MIDATA cites the philosopher John Rawls and his idea of “Property-Owning Democracy” in its promotional material. Its founder, Ernst Hafen, predicts that it could make even more money than Google or Facebook — though it would all be reinvested for the good of society.

People who contribute personal information to MIDATA — whether its their genome or smartphone steps log — would remain the owners of their personal info and get to sign off on how its used. Theyd also become shareholders in MIDATA, able to vote on how it conducts business and spends its profits — earned in part by pharma companies who pay to recruit study participants.

MIDATA is starting slowly, with some academic partnerships and some companies interested in how patients are faring with their migraine and multiple sclerosis drugs. But Hafen insists that MIDATA is the future, “a citizen-empowered way of changing the way science is done.”

If patient data is to be collected in public data bases, citizens might have to do the powering. But there are signs the industry is slowly coming around.

Signs point to the pharma industry increasingly being open to sharing data and cooperating on trials, but theyre not eager to talk about it publicly yet. Requests for comment from both the European Federation of Pharmaceutical Industries, the sectors Brussels lobby, and individual companies yielded no one willing to discuss these new initiatives.

Collaboration has never been the pharmaceutical industrys strong suit. While industries like aviation and semiconductors have been working together for decades, “the pharmaceutical industry has been lagging,” said Dalvir Gill, CEO of TransCelerate BioPharma, a non-profit initiative trying to change that.

Over the past seven years, TransCelerate has looked for ways to coordinate clinical trials. They have created a common set of forms for different companies trials. It also created a network for companies to procure comparable drugs from each other directly for use in trials, rather than having to buy the longer-standing treatment from third parties to test against a new drug.

Ten companies signed on to TransCelerate initially, up to 19 now. Its required companies to change their mindset, Gill said.

Theres a “vast amount of work that happens in the development of drugs that is not competitive,” Gill said. “The R&D people get it,” he added, but in the commercial divisions of a company, “theres a lot more convincing that needs to happen there.”

Regulators also need convincing, Gill noted — when companies cooperate, it raises a different set of eyebrows.

“Our biggest barriers are typically not running afoul of antitrust,” Gill said. “Whenever you have 19 companies in a room doing something,” its going to draw scrutiny.

With lots of new cancer drugs coming out for increasingly narrow subsets of cancer patients, so-called platform trials — in which multiple new drugs are tested at once — are seen as a key way to speed up the process and avoid duplication.

But companies are deeply resistant to the idea of having their new idea compared (possibly unfavorably) to someone elses.

The I-SPY 2 trial for breast cancer, non-profit platform trial that has resulted in three drugs winning approval, showed drugs can be tested at the same time without being pitted against each other. Instead theyre tested against the existing standard of care.

Brian Alexander, a Harvard radiation oncologist preparing to launch a platform trial for brain tumors called GBM AGILE, said that the precedent has made it easier for him to convince companies to let him test their drugs.

“They werent as worried anymore because once you see two New England Journal [of Medicine] papers in the same edition, both coming from arms from I-SPY 2, and theyre not compar[ed to] each other… then [drugmakers] were like, Oh, ok, that isnt that much of an issue,” Alexander said.

Hes expecting to announce the first drug to be tested in the new GBM AGILE trial next week, but he said that overcoming companies fear of sacrificing control remained a major challenge.

“To feel like theyre turning over the late stage development of an asset to this other entity — thats a bit of a tough sell,” Alexander said.

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World Bank and WHO Statement on Partnership & Deployment of Financing to WHO for Ebola Response in DRC

WASHINGTON, August 23, 2019—The World Bank and the World Health Organization (WHO), along with the G..

WASHINGTON, August 23, 2019—The World Bank and the World Health Organization (WHO), along with the Government and other key partners, are working in close partnership on the Ebola Crisis Response in the Democratic Republic of the Congo (DRC). Central to this partnership is the assessment of the financing needs, and deployment of resources, with the goal to put an end to the current deadly outbreak.

The World Bank is today announcing that US$50 million in funding is to be released to WHO for its lifesaving operational work on the frontlines of the outbreak. The WHO is announcing that this US$50 million in funds will close the financing gap for its emergency health response in DRC through to the end of September 2019, and is calling on other partners to mirror this generous support in order to fund the response through to December.

The funding comprises US$30 million from the Pandemic Emergency Financing Facility (PEF) and US$20 million from the World Bank. The US$50 million in grant funding is part of the larger financial package of approximately US$300 million that the World Bank announced last month to support the fourth Strategic Response Plan for the DRC Ebola outbreak.

“WHO is very grateful for the World Banks support, which fills a critical gap in our immediate needs for Ebola response efforts in DRC, and will enable the heroic workers on the frontlines of this fight to continue their lifesaving work,” said Dr. Tedros Adhanom Ghebreyesus, Director-General, World Health Organization. “We keenly await further funding from other partners to sustain the response through to the end of the year.”

The DRC government, working in collaboration with the World Bank, WHO, and other key partners, has finalized the Fourth Strategic Response Plan (SRP4), which outlines the total resources needed for the DRC Ebola Crisis Response from July to December 2019. The financing announced today is part of the World Banks previously announced financial package of up to US$300 million and covers over half of SRP4s needs, with the remainder requiring additional funding from other donors and partners.

“The World Bank is working closely with WHO, the Government of DRC, and all partners to do everything we can to put an end to the latest Ebola outbreak,” said Annette Dixon, Vice President, Human Development at the World Bank. “The partnership between our organizations and the Government is critical for responding to the emergency as well as rebuilding systems for delivery of basic services and to restoring the trust of communities.”

The Government of DRC requested US$30 million from the PEF Cash Window to be paid directly to WHO. The PEF Steering Body approved the request bringing the PEFs total contribution to fighting Ebola in DRC to US$61.4 million. The PEF is a financing mechanism housed at the World Bank; its Steering Body is co-chaired by the World Bank and WHO, and comprises donor country members from Japan, Germany and Australia. The quick and flexible financing it provides saves lives, by enabling governments and international responders to concentrate on fighting Ebola—not fundraising.

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Borno State launches first Malaria Operational Plan, reawakens fight against malaria

Maiduguri, 13 August 2019 – Following recommendations from malaria interventions in Borno State Nige..

Maiduguri, 13 August 2019 – Following recommendations from malaria interventions in Borno State Nigeria, the Malaria Annual Operational Plan (MAOP) was developed and launched on 08 August 2019 with technical support from the World Health Organization (WHO) and partners. Aligned to the National Malaria Strategic Plan (2014 -2020), MAOP was developed through a broad-based stakeholders workshop involving malaria stakeholders, reviewed on different thematic areas and endorsed by the Commissioner for Health and Permanent Secretary, Borno State Ministry of Health.

Speaking during the launch, the Borno state Malaria Programme Manager, Mr Mala Waziri described the MAOP as the first to be endorsed and disseminated in Borno State. “WHO has made us proud by supporting the first ever Malaria Operational Plan right from development, review, printing to dissemination.”

Dr Ibrahim Kida, the Ministerial Secretary Borno State Ministry of Health and Incident Manager of the state, described the launch as “an historic event as stakeholders across the health sector made commitments to use the document as an implementation guide for all malaria programs”. The plan was also described as an advocacy tool for planning domestic funds mobilization.

The MAOP has seven objectives among which are: provide at least 50% of targeted population with appropriate preventive measures by 2020; ensure that all persons with suspected malaria who seek care are tested with Rapid Diagnostic Test (RDT) or microscopy by 2020 and all persons with confirmed malaria seen in private or public health facilities receive prompt treatment with an effective anti-malarial drug by 2020.

The MAOP will further ensure that at least 50% of the population practice appropriate malaria prevention and management by 2020, ensuring timely availability of appropriate anti-malarial medicines and commodities required for prevention, diagnosis and treatment of malaria in Borno State by 2020.

In addition, it seeks to ensure that all health facilities report on key malaria indicators routinely by 2020 and finally strengthen governance and coordination of all stakeholders for effective program implementation towards an A rating by 2020 on a standardized scorecard. These strategic objectives have specific targets and the MAOP takes into account the humanitarian response.

“Malaria remains a leading cause of poor health in Nigeria. According to the 2018 WHO Malaria Report, 53million cases are recorded annually in Nigeria, roughly 1 in 4 persons is infected with malaria contributing 25% of the global burden,” says Dr Nglass Ini Abasi, WHO Malaria Consultant for the North East.

“Furthermore, 81,640 deaths are recorded annually (9 deaths every hour), which accounts for 19% of global malaria deaths (1 in 5 global malaria deaths) and 45% malaria deaths in West Africa. The Nigeria Malaria Strategic Plan (NMSP) 2014-2020 has a goal to reduce malaria burden to pre-elimination levels and bring malaria-related mortality to zero and WHO is working assiduously with Government to ensure the burden is reduced accordingly.”

Results from WHO’s Early Warning, Alert and Response System (EWARS) week 30 report from 223 sites, (including 32 IDP camps) show that malaria was the leading cause of morbidity and mortality accounting for 35% of cases and 46% of reported deaths. In addition, results from the Nigeria Humanitarian Response Strategy (NHRS 2019-2021) indicate 7.1million people are in dire need of healthcare and 6.2million are targeted for immediate attention.

Despite recent improvements, insecurity remains a challenge limiting access to the functional health facilities. Easily preventable and treatable diseases such as malaria, acute respiratory infection and diarrheal diseases account for the greatest proportion of morbidity and mortality among the vulnerable population. Furthermore, Malaria is endemic in North East Nigeria and the transmission is perennial with a marked seasonal peak from July to November every year. (more…)

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Nearly half of all dengue deaths in the Philippines are children under nine years old

Manila, August 16 – At least 300 children aged 5-9 have died in the recent Dengue outbreak in the Ph..

Manila, August 16 – At least 300 children aged 5-9 have died in the recent Dengue outbreak in the Philippines, Save the Children said today, amid fears the epidemic could claim many more lives before its brought under control. In the first seven months of 2019, some 170,000 people were infected with the disease, killing 720 people – 42 percent were children between 5 and 9 years old. Compared to the same period in 2018, this years dengue caseload is 97 per cent higher. The virus is disproportionately affecting children and young people with a staggering 73 per cent of recorded cases under the age of 19.

Albert Muyot, ceo of Save the Children in the Philippines, said: “Hundreds of children have sadly already died, we expect the numbers to rise. The rainy season started late and will continue this month, creating the perfect breeding ground for dengue mosquitoes.

“Children are particularly a vulnerable to the disease because their immune systems are weaker than adults and they tend to play outside where theres less protection against the mosquitos. Schools in particular are a hotbed of dengue because many have open windows and lack mosquito repellents.

“It is extremely important that health authorities step up their information campaigns in schools, communities and other places where people come together, so people know what to do if they suspect dengue. Also, the government must step up their fumigation campaign to kill adult dengue mosquitoes in densely populated areas.

“In the Philippines, we are working with schools and communities to improve awareness on how to prevent infection. To save lives, children need extra protection. Wearing long sleeves and trousers is one of the simple measures to protect against being bitten. Early diagnosis is critical and we are raising awareness of those symptoms, like fever and body pain, and encouraging all parents to take their children to hospital immediately if they have concerns.

“Save the Children is referring child dengue cases to health centers in vulnerable communities in Navotas, Caloocan and Malabon as well as in conflict-affected provinces in Bangsamoro Automous Region in Muslim Mindanao (BARMM).”

Notes to editors:

  • Dengue causes flu-like illness, including a sudden high fever coming in separate waves, pain behind the eyes, muscle, joint and bone pain, severe headache, and a skin rash with red spots. People with symptoms get ill between 4 to 7 days after a bite from an infected Aedes mosquito.
  • The illness can become the fatal Severe Dengue, characterised by severe abdominal pain, vomiting, diarrhoea, convulsions, bruising, uncontrolled bleeding, and high fever which can last from 2 to 7 days.
  • Complications can lead to circulatory system failure, shock, and death.
  • There were 167,607 dengue cases between January-July 2019, up from 85,011 in the same period in 2018.
  • Of the 167,607 recorded cases of dengue between January and July 2019, 121,942 were under the age of 19.
  • On August 6th, the government declared a national dengue epidemic.
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