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Archive for August 2019

Science Policy Around the Web August 30th, 2019

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By Andrew Wright, BSc

Image by Steve Buissinne from Pixabay

EPA’s controversial ‘secret science’ plan still lacks key details, advisers say

In early 2018 under its previous administrator Scott Pruitt, the U.S. Environmental Protection Agency (EPA) first proposed rules to restrict the use of scientific findings whose data and methodologies are not public or cannot be replicated. Following the removal of all sitting Science Advisory Board (SAB) members who receive EPA grants in late 2017 (roughly half of its members) there was concern that environmental experts were being sidelined from EPA decision-making, which the proposed rule seemed to support. While making data public and replicable has merits, the SAB has raised concerns that the proposed rule would make it impossible to use the most accurate information as many environmental studies are long-term ones that assess human exposure to toxins and cannot be ethically or efficiently replicated. Now, under administrator Andrew Wheeler, how this proposed rule will be implemented is still unclear. 

A central concern is how to maintain privacy over personally identifiable information (PII) to comply with existing privacy laws and concerns (such as the Health Insurance Portability and Accountability Act or HIPAA). One proffered strategy is to try a tiered approach based of the model currently used by the National Institutes of Health, whereby the more sensitive the PII is, the more restricted its access will be. 

As the SAB has decided to engage in a consultation of the proposed rule, individual members will have their comments written up in a report to be sent to Wheeler but will not have to come to a consensus for the proposed rule to move forward.  

(Sean Reilly, Science (Reprinted from E&E News

 Brazilian Amazon deforestation surges to break August records 

While the recent spate of fires in the Amazon rainforest have been capturing international attention, regular deforestation via cutting and clearing techniques have also been rapidly increasing. In August alone, 430 square miles, or a region the size of Hong Kong, has been cut down. This comes after the July’s loss of 870 square miles, a 275% jump from the previous year.  At the current rate of deforestation Brazil is on track to lose more than 3,800 square miles of rainforest, or an area roughly one and a half times the size of Delaware, this year.

“The August data from Deter is hardly surprising,” said Claudio Angelo of Climate Observatory, referencing the Deter-B satellite that was put into place in 2015 to monitor Brazil’s rainforests. According to him and other representatives from non-governmental organizations, the Bolsonaro government is delivering on its promises to support local industries such as mining, ranching, farming, and logging rather than enforcing environmental protections. 

While this deforestation data is separate from data on forest fires, felled trees are often left to sit and dry before they are lit aflame, leading forest engineers to portend that the fires are going to get worse in the coming months.

Since the Amazon rainforest generates its own weather patterns, studies have demonstrates the possibility that after 40% deforestation has occurred, the biome may irreversibly convert to savannah. This could impact global weather patterns, affected Brazilian weather most severely. However, recent estimates place that tipping point closer to 20-25% due to the synergistic effects of climate change. According to the World Wildlife Fund, approximately 17% of the rainforest has been lost in the past 50 years, putting uncontrollable forest conversion much closer than previously assumed.

(Jonathan Watts, The Guardian

Written by sciencepolicyforall

August 30, 2019 at 11:08 am

Science Policy Around the Web August 26th, 2019

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By Silvia Preite PhD

Image by PublicDomainPictures from Pixabay 

NIH will soon share genetic data with those who participated in precision medicine study

In 2018 the National Institutes of Health (NIH) launched the All of Us Research Program to collect multiple types of data from more than one million volunteers living in the United States. The aim of the program is to accelerate medical breakthroughs and promote human health on a large scale. All of Us is a key element of the Precision Medicine Initiative (PMI), with the long-term goal of integrating information on genetic composition, lifestyle and environment to reveal strategies for personalized prevention and treatment of a wide range of health conditions. 

Participants provide medical records along with genomic material, blood and urine samples. In addition, digital data recorded through smart phones and other electronic devices are stored to obtain extended pictures of the individual health status and life habits.

So far, about 200,000 Americans have joined the All of Us initiative. By late 2019-early 2020, 25,000 US citizens will get back their genomic information along with genetic counseling. On August 21 2019, the All of Us director Eric Dishman announced a new partnership with the California-based health technology company, Color Genomics to provide the counseling service. The genetic counseling services provided by Color Genomics will play a crucial role in communicating the genomic results to participants and their personal physicians, as well as helping them understand the implications for their health and families. These data will supply information on genetic variants that could predispose to certain diseases and influence responses to pharmacological treatments.

In particular, counseling will be given to those individuals who carry any genetic mutations that geneticists have linked to severe diseases – such as mutations in the BRCA gene associated with breast cancer.

This will be the first time that a government funded study will return genetic data to the participants on such a large scale. Another distinguished element of this study is the heterogeneity of the involved population. Up to now, half of the participants have been selected within ethnic and socio-economic groups that have been historically marginalized and under represented in research and clinical studies. Moreover, researchers could gain access to these open-source and anonymized data to investigate previously unknown genetic traits that influence human health and disease development, greatly broadening the availability and heterogeneity of data for these studies.

(Lev Facher, STAT News)

 

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August 27, 2019 at 2:38 pm

Science Policy Around the Web August 23rd, 2019

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By Allison Cross PhD

Source: Flickr

A Once Common Gecko Is Vanishing from Parts of Asia

The tokay gecko, once commonly found across Southeast Asia, southern China and India, is now becoming a lot less common. Recently studies assessing gecko population trends suggest that populations have declined as much as 50 percent in China, Vietnam, Thailand, Myanmar, Indonesia, the Philippines and Bangladesh.  This recent decline has scientists and conservationists concerned about major population collapse and even extinction.

The vanishing gecko population is believed to be, at least in large part, due to the large, currently unrestricted, trade of these animals. Though the exact number of tokay geckos captured for trade each year is unknown, the figure is estimated to be at least one million.  Most of these animals are sold to China, where the gecko is used as an ingredient in traditional Chinese medicine. 

Currently, there are no international rules regulating the trade of geckos, but this may soon change.  The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), an international treaty aimed at protecting endangered plants and animals, is set to vote at the end of August on whether geckos should be added to the treaty.  If the vote goes through, countries will be required to monitor and report all trade and prove that it is not harming the gecko population.  While members from Australia, the European Union, India, the Philippines and the U.S. support the addition of the tokay gecko to the treaty, China and Indonesia remain in opposition. 

(Rachel Nuwer, Scientific America)

Treatment for Extreme Drug-Resistant Tuberculosis Wins U.S. Government Approval

The World Health Organization (WHO) estimates about half a million people worldwide are diagnosed every year with multi-drug-resistant tuberculosis (TB), and around 8.5% of cases are characterized as extensively drug-resistant (XDR) TB.  Common TB treatments are ineffective for those suffering from XDR TB and, up to this point, the treatment offered to these patients involved an eight-drug combination taken for more than a year.  This eight-drug combination comes with serious side-effects and is largely ineffective, with as many as two-thirds of patients succumbing to the disease despite treatment. 

For decades, research into development of new TB treatments was rare, but donations from governments and philanthropist in the early 2000s sparked more research in the area. This research has resulted in a new and promising therapy developed by the TB Alliance, a non-profit research group in New York City. The new therapy is a three-drug regimen; pretomanid, bedaquiline, and delaminid.  Clinical trials of the new regimen were extremely promising; 90% of XDR TB patients recovered following 6 months of treatment. This success rate far exceeds the 34% success rate obtained with the current treatment options.

The new XDR TB regimen was approved by the U.S. Food and Drug Administration on August 14th and it has the potential to quickly reach the patients who need it the most.  As TB mostly effects the world’s poorest people, the key to success is to keep the price low. Currently, the TB Alliance is negotiating a price for the latest treatment with the two pharmaceutical companies.

 

(Amy Maxmen, Scientific America) 

 

Written by sciencepolicyforall

August 23, 2019 at 3:18 pm

Science Policy Around the Web August 20th, 2019

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By Mohor Sengupta PhD

Image by Ryan McGuire from Pixabay 

FDA makes new push for graphic warning labels on cigarettes

According to government records, the percentage of smokers in the U.S. has reduced from 40% of the population in the 1960’s to 14%. Despite this dramatic decrease, approximately 480,000 people in the U.S. die each year from diseases directly related to smoking. In an attempt to educate smokers about the dangerous medical consequences of smoking, in 2009 the FDA proposed 9 graphic labels to be printed on cigarette packets. However the FDA’s plan didn’t see the light of day when five tobacco companies challenged the FDA’s decision in court and in 2012 won on grounds of free speech. The judges who ruled in favor of the tobacco companies said that “[the images were] crafted to evoke a strong emotional response,” rather than educating consumers. 

The FDA then backed out saying that it will work on introducing new images and it was soon to announce new proposed labels. In 2016, a lawsuit was filed by health groups against the FDA for not proposing a new plan soon enough. Last Thursday, the FDA announced 13 new graphic labels to be displayed on cigarette packets that would show cancerous tumors, diseased lungs, and feet with amputated toes. The FDA’s tobacco director Mitch Zeller said that these new labels had been designed while keeping in mind the limited public awareness of lesser-known diseases caused by smoking. 

For 35 years, everything that the USA’s cigarette packets have told consumers about the harmfulness of smoking has been contained in a warning statement so tiny that it is missed by most consumers. Research has shown that graphic label inclusion on cigarette packets discourages smokers, and Canada was the first country to adopt this measure in 2000. 

Since then, more data have come to light identifying graphic images as an effect anti-smoking measure. A 2013 study showed that participants tended to respond to graphic labels rather than warning statements on cigarette packets. Another 2013 study estimated that if the FDA had adopted graphic labels in 2012, 5.3 to 8.6 million adults would have quit smoking in a year. They based their results on similar data from Canada where graphic labels are in use. 

It is anticipated that Big Tobacco will challenge the FDA’s move once again. Some of them are already citing the First Amendment as their defense. It is now time to see what is decided if the matter is taken to the courts once again. While thousands of people continue to die because of smoking habits in the USA, and graphic label inclusion on cigarette packets are repeatedly challenged by the tobacco industry, nearly 120 countries across the world have already adopted this measure and are reaping its benefits. 

(Matthew Perrone, STAT)

Experimental Ebola Drugs Saved Lives In Congo Outbreak

Ebola is raging in the Democratic Republic of Congo (DRC). However, a climate of distrust around Ebola clinics compounded with political upheavals in DRC has discouraged patients in the early stages of infection from leaving their community and seeking help in designated Ebola clinics. In this way, the virus has rapidly spread across communities and now threatens people outside of DRC as well. 

Despite these issues, efforts are underway to combat Ebola and develop more effective treatment strategies. A NIAID-funded study that compared four drugs against the Ebola virus recently concluded that two of them showed better results in combating the disease. The study, called ‘Pamoja Tulinde Maisha’ (PALM), is a randomized controlled trial of the four drugs and started on November 2018 as part of the emergency response in DRC.

The four investigational agents were Remdesivir, a commonly used antiviral drug, ZMapp, which showed effectiveness in previous Ebola outbreaks, REGN-EB3, developed by Regeneron and mAb114, a monoclonal antibody jointly developed by NIAID and INRB (in the DRC). 

Having reached a definite conclusion about the effectiveness of the four drugs, the PALM trial stopped earlier than originally scheduled. Preliminary results released on August 9, 2019 show only 30% of Ebola Virus Disease (EVD) patients treated with REGN-EB3 or mAb114 succumbed to the infection, compared to half of those treated with ZMapp or Remdesivir. When analysis was restricted to the relatively healthier patients receiving the more potent treatments, 6% and 11% died on REGN-EB3 and mAb114 treatment regimes respectively. 

With these preliminary results, patients on Remdesivir and ZMapp will now be switched to one of the more effective drugs based on their physician’s discretion. The study will continue to measure the effects of the two drugs from now on. The final analysis of the study data is likely to be made available later this year. 

(Richard Harris, NPR)

 

Written by sciencepolicyforall

August 20, 2019 at 4:56 pm

Science Policy Around the Web August 16th, 2019

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By Neetu M. Gulati PhD

Image by vegasita from Pixabay 

How Eating Less Meat Could Help Protect the Planet from Climate Change

A recent report by the United Nations climate science body, the Intergovernmental Panel on Climate Science (IPCC), warns that now is a moment of reckoning for how humans use the planet. The report highlights how the planet has been impacted by land-use practices, deforestation, agriculture, and other activities. These threaten our ability to limit the global temperature increase as outlined by the 2015 Paris climate agreement. The report further outlines how humans can help stop the impacts of climate change by drastically changing what food we eat as well as how it is produced.

Explaining this logic, Debra Roberts, the co-chair of the IPCC Working Group II, commented, “some dietary choices require more land and water, and cause more emissions of heat-trapping gases than others.” If people eat more sustainably grown and produced foods, as well as more plant-based diets, this could provide opportunities to adapt and mitigate the potential climate issues. Meats like beef and lamb are particularly taxing on the environment for the amount of meat obtained, partially because such livestock require a large space to graze. Reducing the amount of land to produce meat and also using that land more efficiently through sustainable farming practice will be imperitive to ensure that land remains usable as the planet warms. 

While a lot of the world already eats majority plant-based diets, the countries that eat a lot of meat tend to be wealthier countries. As countries with lesser meat consumption gain wealth, there is a risk that they will eat more meat and put a greater strain on the environment. While not every country will stop eating meat, the recent popularity of meatless products is encouraging, and hopefully the public will begin to focus on the fact that food and agriculture are important in the fight against climate change.

(Abigail Abrams, Time)

“Qutrit” Experiments are a First in Quantum Teleportation

Many believe that quantum information science is a key avenue of research for future technologies. Now, for the first time, researchers have used this technology to teleport a qutrit, a tripartite unit of quantum information. This is an important advance for the field of quantum teleportation, previously limited to the quantum equivalent of binary bits of information known as qubits. The two research teams who independently achieved this feat first had to create qutrits from photons, a challenge in and of itself. Because qutrits can carry more information and have more resistance to noise than qubits, these experiments may mean that qutrits become an important part of future quantum networks.

In quantum science, the states of entangled particles have a connection. Thus, in quantum teleportation, the state of one entangled particle, for example the spin of an electron particle, influences the second particle instantaneously, even if far apart. While this sounds like something out of a science-fiction story, this milestone may have important real-world implications. Quantum teleportation may be important for secure communications in the future. In fact, much of the quantum teleportation research is funded because of its importance for the future of cybersecurity.

The qutrit teleportation experiments were independently performed by two research teams. One team, led by Guang-Can Guo at the University of Science and Technology of China (UTSC), reported their results in a preprint paper in April 2019. The other team, co-led by Anton Zeilinger of the Austrian Academy of Sciences and Jian-Wei Pan at the UTSC, reported their findings in a preprint paper in June 2019 that has been accepted for publication in Physical Review Letters. The two teams agree that each has successfully teleported a qutrit, and both have plans to go beyond qutrits, to at least ququarts (four level systems). Other researchers are less convinced, saying the methods used by the two teams are slow and inefficient, and therefore not suited for practical purposes. In response, one of the authors of the paper by Zeilinger and Pan’s team, Chao-Yang Lu, said, “science is step by step. First, you make the impossible thing possible. Then you work to make it more perfect.”

(Daniel Garisto, Scientific American

 

Written by sciencepolicyforall

August 16, 2019 at 3:15 pm

Should Vaccines be Mandatory?

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By: Juan I. Moliva, Ph.D.

Image by Angelo Esslinger from Pixabay 

The anti-vaccination movement has been gaining traction across the United States (U.S.) and the world. According to the Centers for Disease Control and Prevention (CDC), the number of measles cases in the first five months of 2019 surpassed the total number of cases per year for the past 25 years, with the number of children unvaccinated for preventable diseases quadrupling since 2001. The CDC also found an increase in the number of vaccine exemptions for kindergarteners across the U.S. While the numbers vary across the country mostly due to laws set in place by each state, in Mississippi, one of three states that do not grant exemptions due to religious or philosophical reasons, the rate of kindergartners with an exemption to one or more required vaccine was 0.1%. Compare that to Oregon, a state that grants exemptions to vaccines due to religious or philosophical reasons, where the rate of vaccine exemptions for kindergarteners is at 7.6%. As the number of individuals choosing not to get vaccinated or choosing not to vaccinate their children continues to increase, the debate as to whether vaccines should be mandatory has taken front stage.

Simply stated, a vaccine is a weakened or killed version of a pathogen that is delivered to the body with the sole goal of stimulating an immune response to protect you against the disease you are being vaccinated against. How is this accomplished? Your immune system has a subset of cells with “memory” that remember the pathogen and if you are later exposed to the pathogen these “memory” cells will eliminate the pathogen before it can make you sick. In the U.S. and most of the world, the general scientific consensus on vaccines is that they are safe and critical for maintaining healthy communities. The U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) strongly defended the case for vaccines. Chairman Lamar Alexander (R-TN) said, “The science is sound: Vaccines save lives – the lives of those who receive vaccines and the lives of those who are too young or vulnerable to be immunized.” Like any medication or medical procedure, vaccines do not come without risk, but the advantages vastly outnumber any disadvantages.

Not only do vaccines protect your body from dangerous pathogens, they also protect the community via a concept known as herd immunity. When a high enough percentage of the population is immune, pathogens have a harder time spreading. We rely on this principle to protect those who cannot receive a vaccine. However, vaccine opponents continue to argue that mandating vaccines is a slippery slope towards losing body autonomy. I have spent the last eight years studying vaccines, from basic research to pre-clinical testing through clinical trials and licensing. I have recently come to embrace the belief that the sole exemption for a vaccine that has been proven to be effective is a medical one – the case where you cannot receive a vaccine because your body responds negatively to the vaccine; this includes a weakened immune system that can be caused by chemotherapy or radiotherapy, a congenital condition that leads to an impaired immune system, or a history of serious adverse events related to vaccination such as an allergic reaction to one or more components in the vaccine.

The case against anti-vaxxers surrounds the choices they make on behalf of their children and how those choices affect their children and those in the community. If parents started claiming religious or philosophical exemptions against child safety seats or against buckling their children while driving, would we be arguing in their favor? Seatbelts and safety seats have been proven to save lives by preventing ejection from the vehicle after impact. Vaccines have been medically proven to save lives by preventing death or disability from infectious pathogens after exposure. While we expect not to be involved in a car accident, we rely on seatbelts in case we do. Vaccines work the same way; we do not want to be exposed to deadly pathogens but being vaccinated against these pathogens helps ensure we do not get sick if we do. Childrenare incapable of deciding if they want to be vaccinated as some vaccine regimens are initiated within the first year of life, thus their welfare is entrusted upon their parents. 

In the U.S. we have laws about providing proper nutrition, schooling, clothing, cleanliness, shelter, and many more that protect children’s welfare. Providing vaccines on time should be included as a basic necessity and be treated no different than other child welfare offenses. If an unvaccinated child contracts a preventable disease and is significantly affected to the point of disability or even death, the parent(s) should be directly responsible. A guardian refusing to vaccinate their medically eligible child should be treated like what it is: child endangerment. Take for example the recent case of a six-year-old in Oregon that nearly died of tetanus after sustaining a cut while playing outdoors. The child’s parents had refused to vaccinate the child with DTaP, a safe vaccine intended to protect against tetanus. The boy was held in an intensive care unit for 47 days, undergoing multiple intravenous infusions to alleviate the high fever, hypertension, and tachycardia caused by the infection. All at the cost of over $800,000 for a disease that could have been easily prevented with vaccination. Despite the episode, the boy’s parents continue to refuse the vaccine.

Although bipartisan support exists for vaccination at the federal level, it is unlikely federal law eliminating philosophical and/or religious exemptions would come to pass as public health policy is traditionally left to the states. State legislatures are beginning to introduce laws that will help limit the increase in numbers of preventable disease cases due to lack of vaccination. New York state recently passed legislation forbidding religious and non-medical exceptions to vaccines. After signing the bill, Governor Cuomo (D-NY) said, “While I understand and respect freedom of religion, our first job is to protect the public health.” Washington state, plagued by surging number of measles cases, also recently banned personal and philosophical exemptions to the MMR vaccine, which protects against measles, mumps, and rubella. Merely going to a public park or a grocery store can place unvaccinated children or immunocompromised individuals at risk of contracting a preventable disease. Such was the case of a six-year old boy with leukemia that died of measles after being exposed by his intentionally unvaccinated siblings. Senator Bill Cassidy (R-LA), a former physician, stressed: “If you are such a believer in liberty that you do not wish to be vaccinated, there should be a consequence and that should be that you cannot infect other people.” While I agree that autonomy over one’s body is important, the government has the right to require a reasonable level of vaccination for all citizens as a matter of public health. 

In the U.S. where freedom and personal liberty are valued above all else, mandatory vaccination would have a lengthy and challenging uphill battle. Additionally, data suggests that mandatory vaccination does not necessarily increase vaccination coverage. Instead, the U.S. could increase vaccinations via financial incentives similar to the system in place in Australia whereby parents receive monetary compensation when their children meet vaccination requirements. However, the most successful approach might be akin to the one the CDC implemented over sixty years ago to encourage stricter vaccination requirements by the states. By providing educational support, the CDC engaged parents, policymakers, and state and local health officials at every level to increase vaccination coverage. Education is one of the most effective ways to counter vaccination noncompliance. Specifically, educating people on the alternatives to vaccines – the morbidity and the mortality associated with lack of vaccination – was shown to be the most effective strategy. Educating why vaccines are so crucial is the most powerful weapon to combat vaccine non-compliance. 

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Written by sciencepolicyforall

August 14, 2019 at 10:00 am

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Science Policy Around the Web August 9th, 2019

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By Ben Wolfson PhD

Image by OpenClipart-Vectors from Pixabay 

Scientists are making human-monkey hybrids in China

In a new report first published by Spanish newspaper El Pais, it was revealed that an international team of scientists lead by Dr. Juan Carlos Izpisúa have created human-monkey chimeras, with the end goal of growing human organs in monkeys for transplant.

Chimeras are organisms with cells coming from multiple genetically distinct individuals. Chimeras are commonly used for biomedical research, such as mice bred to express genes from other species, or immunocompromised animal models in which foreign tumors are introduced to facilitate cancer research.

While these uses are commonplace, the ethical ramifications of human-animal chimera creation are significant. If chimeras are created at early developmental stages, it is difficult to control the destiny of each individuals’ cells, meaning that human cells could end up in the nervous system or brain, potentially resulting in human-like behaviors. Due to these considerations, the National Institutes of Health have banned the use of federal funds to create human-monkey embryos, and the scientific community has instituted an unofficial “red-line” to cut off chimeric embryo growth at 14 days.

To avoid legal issues, Izpisúa’s team (based in the US and Spain) conducted research in China, where no legal limitations currently exist. In previous work producing human-pig and human-sheep chimeric embryos, Izpisúa reported that only 1 in 10,000 cells were human. While the results of his human-monkey research remain confidential as they await publication, a colleague stated that “the results are very promising“.

(Antonio Regalado, MIT Technology Review)

 

Written by sciencepolicyforall

August 9, 2019 at 3:38 pm

Disparity in the Global Supply and Demand for Vaccines Against Rotavirus

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By: Lawrence Wang

Image by Arek Socha from Pixabay 

Vaccines are extremely important for individual and global health. These life-saving biologics are especially important for children in developing countries, who suffer disproportionately from vaccine-preventable infectious diseases. One of these infectious diseases is rotavirus, which causes severe diarrhea and kills around 200,000 young children and babies per year1. Effective vaccines against rotavirus are responsible for saving countless lives and reducing suffering around the world.

In November 2018, the major pharmaceutical company Merck canceled a long-term commitment it made with GAVI (The Global Alliance for Vaccines and Immunization) to provide its rotavirus vaccine, RotaTeq, to four countries in West Africa (Burkina Faso, Cote d’Ivoire, Mali, and Sao Tome) for $3.50 a dose. Simultaneously, Merck increased RotaTeq shipments to China where a course sells for $40, nearly 12 times more than in West Africa2. Merck reported that the reason for this termination was “supply constraints” and an “unprecedented increase in global demand” for Rotateq3. Vaccines that were earmarked for West Africa were instead diverted to China, where they would protect millions of Chinese children while leaving millions of West African children vulnerable.

This situation exemplifies the disparity in the global supply of, and demand for, vaccines. Many vaccines are produced by large pharmaceutical companies like Merck that are based in wealthy nations (e.g., Merck’s headquarters are in New Jersey, USA). In general, developed countries have more agency in purchasing and providing vaccines for their citizens at higher prices. Developing countries, on the other hand, usually lack the money to pay for vaccines and are consequently reliant on free or subsidized vaccines. Profit-driven companies such as Merck are thus incentivized to sell their limited supply of vaccines to countries that can afford to pay more.

GAVI and UNICEF (United Nations Children’s Fund) are organizations that work to address disparities in vaccine access between industrialized and developing countries by buying and delivering vaccines to poor countries around the world4,5. However, they still rely on pharmaceutical companies to produce the vaccines that they distribute. When Merck notified GAVI and UNICEF that it would stop supplying discounted RotaTeq doses to the four West African nations, their only recourse to address the unexpected vaccine supply shortage was to help the affected countries switch to anot­­her rotavirus vaccine produced by a different company2.

This potentially problematic situation was avoided by a multilateral collaboration between aid organizations, governments, and manufacturers. Specifically, other pharmaceutical companies like GlaxoSmithKline (GSK), Serum Institute of India, and Bharat Biotech stepped in to fill the dearth left by Merck by pledging to supply their rotavirus vaccines (Rotarix, Rotavac, and Rotasiil) to the four West African countries. These countries are expected to switch to these alternative vaccines (which are actually cheaper than Merck’s) in 2020 after their supplies of RotaTeq run out6.

While this story ostensibly has a happy ending, it also highlights inherent problems in the way vaccines are supplied to the world, specifically poorer nations. These nations are reliant on aid organizations like GAVI and UNICEF to provide them with free or discounted vaccines, which are in turn dependent on profit-driven pharmaceutical companies to produce and supply the vaccines. Why can’t these multinational pharmaceutical companies, which have vast resources at their disposal, just produce more vaccines when there is a shortage?

The answer to this question is multifactorial. Firstly, vaccine production is complicated and only multinational pharmaceutical companies have the sufficient expertise, infrastructure, and manpower to produce high-quality vaccines that are safe and effective at scale. Thus, even these companies need advanced warning to produce millions of vaccine doses. Secondly, the prices for vaccines have been increasing in recent years, mostly due to high fixed overhead costs and exclusive licensing practices that preclude competition7. Thirdly, vaccines represent only about 2-3% of big pharma’s trillion-dollar production portfolio and are not the most profitable part of their portfolios8. Thus, pharmaceutical companies have little incentive to pick up the slack. How, then, can the costs of vaccines be reduced and who is supposed to step up to make vaccines when big pharmaceutical companies fall short of their obligations?

One potential solution to reduce the cost of vaccine production is for smaller pharmaceutical companies to produce generic vaccines. Generics are alternative versions of patented drugs and vaccines that are supposed to work just as well as the original formulation. In fact, India has become one of the world’s leading producers of generics and is a major source of vaccines and drugs for Africa. The issue with this solution is that the generics manufacturing industry is fraught with regulatory issues such as poor quality control and lack of oversight9. Africa is most starkly affected by these issues because manufacturers ship their lowest-quality drugs to the continent. Some of these products are completely counterfeit, with no active ingredients, while others have only a fraction of the active ingredients listed10. Without fixing quality control and oversight of generics manufacturing, this is not a viable long-term solution to provide vaccines to poor countries.

Another potential solution to increase vaccine coverage in Africa specifically would be to empower the continent to manufacture its own vaccines. Though Africa is home to nearly 17% of the world’s population, it produces less than 1% of the world’s vaccines and spends millions purchasing vaccines from foreign entities. For instance, African governments imported $900 million worth of basic vaccines for children in 201411. GAVI and UNICEF could partner with pharmaceutical companies to spearhead capacity building in specific African countries so they could produce their own vaccines, instead of making them dependent on vaccines from third parties. Apart from providing vaccines, this strategy would potentially build local biomedical capacity, provide jobs, and incentivize highly educated African expatriates to return to their home countries12.

Unfortunately, global vaccine stakeholders are hesitant to invest in building vaccine production capacity in Africa. For instance, profit-driven pharmaceutical companies tend to invest in healthy markets that will yield stable returns on their investments. Before investing in building a manufacturing facility, these companies must first ensure that the vaccines they produce will be bought for a certain price at a certain time12. Besides, It will be an uphill battle if Africa cannot produce vaccines more cheaply than other countries like India, which has already optimized infrastructure for producing vast quantities of vaccines cheaply13. Overall, there are many economic barriers that prevent Africa from developing its own vaccine manufacturing infrastructure.

In conclusion, the recent story revolving around providing rotavirus vaccine for West African countries exemplifies the complex challenges in supplying vaccines for the world, especially developing countries that contain some of the world’s most vulnerable populations. Despite the relatively vast resources that global organizations and companies like GAVI, Merck, GSK, and UNICEF have at their disposal, the demand for life-saving vaccines continues to outstrip the supply of vaccines. The bottom line is that vaccines are a vital component to the health of people and nations, and access to these medicines ought to be a universal human right.

  1. https://www.who.int/immunization/diseases/rotavirus/en/
  2. https://www.npr.org/sections/goatsandsoda/2018/11/01/655844287
  3. https://www.fiercepharma.com/pharma/amid-china-launch-merck-cites-supply-limits-plan-to-scale-down-rotateq-shipments-africa
  4. https://www.gavi.org/
  5. https://www.unicef.org/
  6. https://www.npr.org/sections/goatsandsoda/2019/05/31/726863111/it-looked-as-though-millions-of-babies-would-miss-out-on-a-lifesaving-vaccine
  7. https://www.who.int/immunization/programmes_systems/procurement/market/en/
  8. https://www.theatlantic.com/business/archive/2015/02/vaccines-are-profitable-so-what/385214/
  9. https://www.statnews.com/2019/07/22/indian-pharmaceutical-industry-drug-quality-charges/
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4105729/
  11. https://www.dw.com/en/africa-wants-to-manufacture-its-own-vaccines/a-46151389
  12. https://www.frontiersin.org/articles/10.3389/fpubh.2019.00056/full
  13. https://www.thehindu.com/sci-tech/health/trusting-the-science/article25861183.ece

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Written by sciencepolicyforall

August 7, 2019 at 2:45 pm

Science Policy Around the Web August 6th, 2019

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By Allison Dennis B.S.

Image by rawpixel from Pixabay 

Researchers weigh in on Trump’s $500 million plan to share childhood cancer data

Researchers are contemplating developing what they call The Childhood Cancer Data Initiative (CCDI). This approach comes in response to the 10-year $500 million research budget for childhood cancer proposed by President Donald Trump during his January State of the Union Address. Federal officials implementing the proposal have seized on an ongoing effort to transform “big data” into new medical discoveries by looking to expand the sharing of patients’ data to develop new approaches to treat childhood cancers. Currently, patient data can be found spread across state registries, tumor DNA databases, and clinical trial records, obscuring potential insights. 

A symposium held by the National Cancer Institute (NCI) in August 2019, gathered members of the research community to brainstorm the future of the CCDI. Experts made clear the need to first inventory what data already exists, including making efforts to digitally join the five largest existing pediatric cancer databases. Close attention and broad changes will be needed to unify the individual observations being made as children battling cancer make their way through the medical system. Yet despite these big ideas, it is not yet clear that Congress will follow through to appropriate the $50 million down payment needed to kick start CCDI. 

(Jocelyn Kaiser, Science)

 

‘Mosaic’ HIV vaccine to be tested in thousands of people across the world

The ‘mosaic” vaccine is the latest innovation in HIV prevention scheduled to start late-stage clinical trials in September. The experimental vaccine is designed to elicit an immune response to protect against more strains of HIV than any developed so far. The phase III trial (termed “Mosaico”) will be conducted in Europe and the Americas to follow its effectiveness at preventing the transmission of HIV in 3,800 participants, divided evenly into groups receiving four injections of vaccine or placebo. The innovative approach taken by researchers started with engineering a disabled common cold virus to carry pieces of DNA encoding synthetic copies of three HIV genes. The synthetic genes help the body to recognize several different global HIV strains. In addition to the DNA sequences, the vaccine is delivered with two synthetic proteins designed to match HIV strains common in Africa, the Americas, Europe, and Australasia.

Only four HIV vaccines have ever been tested for efficacy in humans. One which initially showed promise but whose efficacy waned over time resulted in a modest 31% difference in rates of infection between groups who received the vaccine compared with placebo. By combining DNA sequences and proteins reflecting a broad diversity of globally circulating HIV strains, the Mosaico team is hoping to give the body an immunological snapshot to prepare it to defend against any strain it might be exposed to. 

(Emiliano Rodriguez Mega, Nature)

 

Written by sciencepolicyforall

August 6, 2019 at 4:47 pm

Where to have a baby? Newborn screening is not created equal.

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By: Emily Wires, Ph.D.

Image by PublicDomainPictures from Pixabay 

In 2017, there were an estimated 3,855,500 live births in the United States, one of whom was my son. Within the first days of life, infants are tested for heritable disorders that can hinder physical and/or cognitive development. Unfortunately, the same set of potentially life-saving tests are not equal for all 3,855,500 infants. 

Since its conception in the 1960ss, newborn screening has been recognized as an essential preventative public health initiative. Serving as a frontline for early detection, conditions included on the screening panel are often considered rare and early intervention is essential to improved quality of life. The Newborn Screening Saves Lives Act was signed into law in 2008 and sought to bring public awareness among parents and health professionals as well as improve newborn screening programs.   

Currently, the panel of tested disorders varies state to state — yes, that means your baby’s health trajectory can be influenced by state lines. When considering birth location, most expecting parents grapple with the pros and cons of hospital versus birthing center versus home birth, but many are naïve to state regulations. Newborn screening standards, specimen collection, and follow-up procedures are implemented by state health departments. Contact information for newborn screening laboratories and follow-up program are available for individual states. Variations in statutes often extend beyond the panel of testable conditions, spilling over to funding for both screening programs and treatments, laboratory standards, and parents’ rights of refusal. To address discrepancies among states, the Department of Health and Human Services (HHS) has provided a Recommended Uniform Screening Panel (RUSP) that includes 34 core conditions and 26 secondary conditions and serves as a suggestive resource for state governments to incorporate as part of their screening programs. RUSP inclusion criteria stipulates a condition be identifiable 24-48 hours following birth, screening tests for the condition are available and validated, and the condition has been shown to benefit from early detection. Conditions included within RUSP are recommended by the Advisory Committee on Heritable Disorders in Newborns and Children along with the HHS Secretary. Despite these recommendations, not all states adhere to RUSP suggestions. 

Orphan drugs are intended to serve the rare disease community but are often commercially underdeveloped owing to their limited profitability. The Orphan Drug Act, passed in 1983, has since served as a legislative springboard set to improve the lives of individuals with rare diseases by incentivizing and accelerating drug discovery. Rare diseases are just that– rare, and because rare diseases are defined as disorders that affect less than 200,000 Americans at one time (with a sizeable proportion belonging to pediatric populations), pharmaceutical companies often expect to incur financial loss developing orphan drugs, which often means a treatment is not pursued. Collectively, however, rare diseases comprise a large healthcare need (an estimated 30 million people in the US are living with a rare disease) and have garnered increased public interest through the work of patient advocacy groupsresearch institutionsgrant funding opportunities, and public events such as Rare Disease Day

So, herein lies the dilemma. Are we essentially running a relay race but missing the handoff? Newborn screening assesses the presence of heritable conditions during a critical development period that otherwise may be missed and parallels an incentivized impetus for drug discovery, yet many states are dropping the proverbial baton regarding panel legislation. Consider, Spinal Muscular Atrophy (SMA) and its recent headlines in the rare disease community. SMA is a debilitating (and deadly), heritable disorder resulting in the loss of motor neurons and subsequent muscle atrophy. In 2016, the Food and Drug Administration approved Spinraza as the first-ever treatment of SMA. The American Academy of Neurology 2019 annual meeting recently reported data from 25 infants diagnosed with SMA at less than six weeks of age who received Spinraza prior to observable symptoms. By 14-34 months, none of these infants required permanent ventilation, all were able to sit and swallow without support, and most of them could walk on their own. However, despite this monumental advancement, not all states include SMA in their newborn screening panel. 

How do we become better for the rare disease community? Admittedly, a loaded question and likely multifaceted in approach. One potential approach would be to federally incentivize universal newborn screening across states. Screening implementation conditions typically vary due to financial constraints, frequency of disorder within state’s population, and treatment availability. California and Pennsylvania are currently the only states that with rare disease legislative caucuses. These bipartisan committees are comprised of individuals dedicated to bridging awareness among policy makers, scientists, patients, and the public. However, there are still discrepancies even among states with caucuses (California tests for 63 conditions, while Pennsylvania tests for 38), attesting to the critical necessity of a universal screening panel. 

Science is making vast strides in the detection and treatment of rare diseases. It is time for public health and policy makers follow suit in an appropriate manner, especially when time may be a crucial factor for our youngest rare disease patients

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Written by sciencepolicyforall

August 2, 2019 at 2:38 pm