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Research Roundup: legislation to expedite antibiotic R&D, a graduated approach to drug patents, and more

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Staphylococcus aureus (MRSA) bacteria (Photo: National Institute of Allergy and Infectious Diseases (NIAID))

Until very recently, no new class of antibiotics had been discovered in nearly 30 years. However, as antimicrobial resistance spreads, there is an urgent need for new antibiotics, particularly those that can treat infections resistant to existing drugs. In article in Health Affairs, Allan Coukell, senior director for health programs at the Pew Charitable Trusts, is calling on Congress to pass the Promise for Antibiotics and Therapeutics for Health (PATH) Act, which would permit the US Food and Drug Administration (FDA) to approve new antibiotics for use in limited patient populations with modified clinical trial requirements that would be determined by the agency itself. There is little financial incentive for antibiotic R&D as they are prescribed for short periods of time and as there is much competition among antibiotics. Conducting clinical trials, particularly for drug-resistant infections, is challenging: not only are these infections rare, but many patients are disqualified from participation due to compromised immune systems or pre-existing conditions. Additionally, the dearth of rapid tests results in many patients starting antibiotic regimens before being diagnosed with a drug-resistant infection. The PATH Act has passed the Senate Health, Education, Labor and Pensions Committee and was included in the 21st Century Cures Act, which passed the House of Representatives last year.

Pharmaceutical company GlaxoSmithKline (GSK) announced that it will not file patents for its products in least developed and low-income countries, enabling manufacturers to produce and distribute generic versions of their medicines in 50 countries with a combined population of nearly 1 billion people. In lower middle income countries, GSK will continue to file patents but will offer ten-year licenses to generic manufacturers for a small royalty. GSK is also exploring innovative ways to increase access to its new and future cancer drugs through voluntary licensing via the Medicines Patent Pool, a United Nations–backed initiative that partners with patent holders and generic manufacturers to facilitate access to medicines. The Pool was founded in 2010, exclusively for HIV/AIDS drug patents, but has since been expanded to include tuberculosis and hepatitis C. Continue reading

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Funding by crisis is no cure for global health threats

Aedes aegypti-mosquitoes which carry Zika. Photo: Dean Calma/IAEA

Aedes aegypti mosquitoes which carry Zika. Photo: Dean Calma/IAEA

April showers bring standing pools of water, the onset of mosquito season, and a new wariness of getting bitten. In 1999, we were caught off guard when the West Nile virus first appeared in North America. In 2010, an outbreak of dengue fever spread locally in Florida after an absence of 60 years. In 2014, chikungunya first arrived in the United States after travelling breathtakingly fast through the Western hemisphere. Now, in 2016, Zika virus is the latest mosquito-borne disease to threaten Americans. Yet our collective national response continues to be one of short-term planning rather than long-term preparedness.

Since Zika virus arrived in the Americas in May 2015, there has been an alarming spike in reports of birth defects such as microcephaly, particularly in Brazil. Zika infection has also been linked to adverse pregnancy outcomes and Guillain-Barré syndrome—a temporary paralysis that can prove deadly. The World Health Organization has declared Zika a Public Health Emergency.

The virus has now spread to 26 countries, including 312 travel-associated cases in the United States. So far, mosquitoes in the United States haven’t infected anyone, but the Centers for Disease Control and Prevention (CDC) just issued a revised map that shows the mosquitoes that carry this virus and others can be found across the Southern tier of the United States all the way up to southern New England on the East Coast. Continue reading

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President will redirect Ebola funds for Zika, but where is the money from and where will it go?

Aedes aegypti mosquito which carries the Zika virus. Photo: CDC/James Gathany

Aedes aegypti mosquito which carries the Zika virus. Photo: CDC/James Gathany

On Tuesday, the Obama administration announced that it will transfer nearly US$600 million in remaining Ebola funds to fight the growing threat of Zika virus.  But many questions remain. Where is the money going? From what accounts will it come? And what does this mean for the Global Health Security Agenda (GHSA) programming which is supposed to help protect against these threats in the future?

In February, the President requested $1.9 billion in emergency appropriations to combat the Zika virus outbreak, but authorization was stalled by members of Congress who suggested the Administration reallocate existing funds instead. The Administration continues to stress that the full request is still needed to fight both Zika and complete the Ebola response. With the announcement of the transfer of funds, the Administration is signaling that the risk of waiting for Congress to act on a supplemental funding is too great, and deploying additional funding to address Zika is essential in the short-term—before the summer weather leads to a broader spread of the mosquito-carried virus.

Reallocating Ebola funding to address Zika carries consequences. While the Administration acknowledges that some Ebola funds remained unspent, much of this money has been allocated to implement the GHSA—a commitment to help at least 30 countries prevent, detect, and respond to emerging disease threats. GHSA has not received any direct appropriations, largely due to sentiment that remaining Ebola balances should cover the cost. Additionally, as the Ebola response remains unfinished—health systems in West Africa remain fragile and we have not yet developed approved Ebola vaccines or treatments—diverting funding before we have finished the job remains risky. Continue reading

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Research Roundup: Mosquitos and mice in the fight against Zika

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Zika virus (Photo: CDC/Cynthia Goldsmith)

Amid the Zika outbreak and with new vector control approaches in the pipeline, there has been much talk about the feasibility and potential risks and benefits of eradicating mosquitos. National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci advocated for mosquito elimination in a recent STAT News article, joking that their only known role in the natural ecosystem is feeding birds. However, Dr. Andrew Dobson, a professor of ecology and evolutionary biology at Princeton University, argues that such an approach would be “naïve and foolish,” noting that there are more than 3,000 mosquito species, hundreds that bite humans, but just three that are responsible for the vast majority of human disease transmission. Further, Dobson suggests that we can’t predict the consequences of mosquito eradication on the natural ecosystem, and that it could lead to the development of insecticide-resistant mosquitos.

Meanwhile, NPR asked experts about the feasibility of eradicating even just one mosquito species and the resources required for it to be successful. First, global coordination mechanisms and high-level political will would be required, i.e., through the appointment of a United Nations mosquito czar. Next, financial resources are a must, with Pennsylvania State University Biologist and Entomologist Dr. Andrew Read estimating that US$250-500 million would be required to eliminate the Aedes aegypti mosquito—responsible for transmitting Zika, yellow fever, dengue, and chikungunya—a high pricetag but one that pales in comparison to the $1.5 billion pharmaceutical company Sanofi spent on developing a vaccine against just one of those diseases, dengue fever. With all the resources in place, the czar would then have to determine which vector control approach to take. As pathogens grow resistant to existing insecticides, both new insecticides and mutant mosquito interventions are under development. British biotech company Oxitec is currently testing its sterile-male mosquitos in Brazil. Oxitec’s mosquitos are released into the wild where they mate with female A. aegypti mosquitos, producing offspring that don’t live to adulthood and consequently can’t infect humans. The approach has resulted in an 82 percent decrease in the presence of A. aegypti larvae in the region in just nine months. Another intervention involves releasing mosquitos infected with Wolbachia bacteria, which then spreads among the mosquito population and can reduce the mosquitos’ ability to produce healthy offspring and to transmit viruses to humans. Finally, scientists are developing mosquitos using “gene-drive” technology, which involves releasing mosquitos genetically modified to be unable to lay eggs or transmit diseases.  Continue reading

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Research Roundup: Identifying people at-risk for TB, a device to aid IUD insertion, and vaccines against cancer

One-third of the world’s population—more than 2 billion people—has latent tuberculosis (TB) and each year, 9.6 million people develop active TB. However, a team of scientists have identified 16 genes, referred to as a “risk signature,” that can predict which cases are most likely to progress to active TB. In two studies enrolling more than 10,000 participants across South Africa and Gambia, researchers collected and analyzed blood samples to detect the presence of the risk signature. The genes predicted cases of active TB with sensitive and specificity rates of 66.1 percent and 80.6 percent: in other words, two-thirds of the patients with the genetic risk signature developed active TB during the study, compared to only one-fifth of those without the risk signature. TB is the world’s leading infectious disease killer, resulting in 1.5 million deaths in 2014. However, the study suggests that this risk signature could be used to predict cases of active TB up to 18 months in advance, and treating latent TB can reduce the risk of developing the disease by 90 percent.

A new tool to easily insert intrauterine devices (IUDs)—long-acting contraceptive devices that can remain in the uterus for up to twelve years—could make the devices more accessible in low-resource settings. IUDs contain either copper, which is toxic to sperm, or hormones that preclude the release of eggs from the ovaries. The devices are safe and more than 99 percent effective, however, they can be difficult to insert. However, a new IUD inserter could make the contraceptive devices much more accessible, particularly for postpartum woman. The inserter was developed by Population Services International, in partnership with Stanford Program for International Reproductive Education and Services and Pregna International Ltd., costs just US$1, and is longer and sturdier than existing tools. In a trial enrolling 80 women in India each of whom had given birth just hours before, 90 percent of health workers reported that the IUD was easy to place with the new inserter and more than 90 percent of women felt no increase in pain during the procedure. Improved inserters could have a significant impact in settings without ultrasound technology—used to confirm the placement of the IUD—or with limited ability to sterilize equipment.

Measles Vaccine Campaign in Tanzania

Photo: PATH/Wendy Stone

Next Billion took an in-depth look at existing vaccines to prevent and treat cancer, emphasizing their need in low-resource settings, where cancer testing and treatment are often inaccessible and prohibitively expensive. Rather than targeting pathogens, these vaccines train the immune system to attack cancerous cells. There are currently preventative vaccines available against strains of human papillomavirus (HPV) and hepatitis B virus that cause cervical and liver cancer, respectively, and other vaccines available and under development can prevent the spread or relapse of bladder, prostrate, and lung cancer. Continue reading

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Take 1.5 minutes for 1.5 million lives

In this guest post, Dara Erck, vice president of External Affairs at Aeras, a global nonprofit biotechnology organization, highlights a new video launched on World TB Day to raise awareness of the urgent need for new tools to combat tuberculosis (TB).

There’s something different about World TB Day this year.

What’s different? World TB Day falls on the same date as always, March 24. It’s the context that is different. This is the first World TB Day since the World Health Organization (WHO) announced that TB was responsible for more deaths than HIV/AIDS. It is also the first World TB Day since the United Nations endorsed its new Sustainable Development Goals (SDGs), which include a target to end the TB epidemic by 2030. It’s an ambitious target. But it is achievable if we have the tools we need. That’s why improving the funding stream for TB research and development (R&D) is so urgent.

TB kills more people than any other single infectious disease agent. In 2014, 9.6 million people became sick with TB and 1.5 million died. That’s one person every 21 seconds. And while it’s extremely important to improve diagnosis and treatment rates for TB, there’s another critical element that is required to end the epidemic. The WHO and other experts agree we need new tools, including better treatments, diagnostics, and vaccines, to achieve the SDG target. Yet, R&D for TB is consistently underfunded.

To help raise awareness about the urgent need for these new tools, Aeras is launching this new video for sharing on social media. It’s only about 1.5 minutes long—easy to watch and easy to share. Please help spread the word and raise awareness about this neglected disease and the urgent need for better drugs, diagnostics, and vaccines.

 

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