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Science Policy Around the Web November 15th, 2019

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By Mohor Sengupta PhD

Image by David Mark from Pixabay

Rollout of Johnson & Johnson Ebola vaccine begins in Congo

To the African countries reeling with the second deadliest Ebola outbreak in history, two back-to-back launches of new vaccines may be a beacon of hope. On Tuesday this week, Merck’s vaccine Ervebo was pre-qualified by the WHO, meaning that it was declared safe for use. This occurred merely 48 hours after the European Commission granted conditional marketing authorization for the vaccine. The speed of this decision-making sheds light on the gravity of the situation at hand. 

The current outbreak in the Democratic Republic of Congo has killed more than 2,200 people. The previous Ebola outbreak, and the deadliest in living memory, rocked West Africa in 2013-16, claiming 11,300 lives. 

In addition to Ervebo, a new vaccine produced by Johnson & Johnson was approved yesterday. It passed several clinical trials, however it will now be tested for the first time in a real world setting in the village of Goma, on the Rwandan border with DRC. It will be administered to 50,000 people. 

The new vaccine by Johnson & Johnson is aimed at complementing Ervebo. While the later requires a single shot, the Johnson & Johnson vaccine will require two shots spaced at 8 weeks. Ervebo is being used as “ring-vaccination”, a strategy in which close contacts of Ebola-infected individuals will be vaccinated.  

(Reporting by Fiston Mahamba; Writing by Hereward Holland; Editing by Anna Pujol-Mazzini and Mark PotterReuters)

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November 15, 2019 at 4:35 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)

 

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August 20, 2019 at 4:56 pm

Science Policy Around the Web – July 12th, 2019

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By Mohor Sengupta, Ph.D.

Source: Maxpixel

CDC made a synthetic Ebola virus to test treatments. It worked

During the 2014-2016 Ebola outbreak in Guinea, West Africa, infectious samples containing the virus were shared by local government with international scientific communities. Using these materials, Dr. Gary Kobinger and his team developed and tested the efficacy of a monoclonal antibody vaccine at the Canadian National Laboratory. The same vaccine, ZMapp, and other therapies are currently being deployed in the most recent Ebola outbreak, which is the second largest outbreak so far. Beginning in ] 2018 in the Democratic Republic of Congo (DRC), this outbreak is still on the roll. Unfortunately, the Centers of Disease Control and Prevention (CDC) did not have any viral samples this time, meaning they were unable to test the efficacy of ZMapp and other drugs against the recent viral strain. 

Scientists at the CDC, led by Dr. Laura McMullan, constructed an artificial virus from the sequence of the current strain shared by DRC’s National Biomedical Research Institute (INRB). The group used the sequence data to perform reverse genetics and generate the authentic Ebola virus that’s currently infecting scores of people in Ituri and North Kivu provinces of DRC. 

“It takes a lot of resources and a lot of money and a lot of energy to make a cloned virus by reverse genetics. And it would be so much easier if somebody had just sent the isolate”, Dr. Thomas Geisbert, who is not involved in the work, said. 

The CDC group established the efficacy of current treatments (a drug called Remdesivir and the vaccine ZMapp) on the viral strain by using their artificial virus for all the tests. Their work was published Tuesday in the journal Lancet.

For all four Ebola outbreaks that the DRC has seen, healthcare authorities have not shared viral specimens with foreign Ebola researchers. Instead, the whole genome sequence was provided every time. With the whole genome sequence data, the Lancet paper noted that there are at least two Ebola strains in DRC that have independently crossed into the human population.  

Reasons for not sharing viral samples by DRC are not known but it is a roadblock to rapid and efficient treatments in affected geographical regions. McMullan said that shipping of samples across such large distances is often a logistical issue and requires permission from several authorities and coordination of many people. 

 (Helen Branswell, STAT)

Plastic Has A Big Carbon Footprint — But That Isn’t The Whole Story

We are all too familiar with ghastly images of dead whales with plastic-filled stomachs. These images are compounded by pictures of how much waste is generated, such as a picture of a twenty-story high mound of plastic trash in a developing country that appeared in a recent news article. While there is worldwide concern about how to eliminate use of plastics, there is very little discussion about the environmental impact of the materials that will replace plastic. 

Plastic has a high carbon footprint. In a recent report the Center for International Environmental Law (CIEL) has broken down the individual steps of greenhouse gas production, from the beginning of plastic production until it ends up incinerated as a waste. Manufactured from oil and natural gas, plastic production adds to carbon footprint right from its cradle when gases and oils leak into the environment. Subsequently, delivery of raw materials to the production sites further add to the burden. Being among the most energy intensive materials to produce, plastic production takes a heavy toll on energy, water and electricity. Finally, when plastics are incinerated, greenhouse gases end up in the environment. 

But what about the materials that commonly substitute for plastic, such as paper, compostable plastic, canvas or glass? What is their carbon footprint in production stages? Research by several independent groups has revealed that these materials leave an even larger carbon footprint during their production. Data have shown that polyethylene plastic bags not only used lesser fuel and energy throughout production, they also emitted fewer global-warming gases and left lesser mass of solid wastes, when compared with paper bags and with compostable plastic bags. Being more durable than other materials, use of polyethylene bags are more energy friendly than use of paper bags. 

Research done on behalf of the American Chemistry Council has shown that replacing plastic would eventually do more harm to the environment than their use. Finally, consumer habits count. If people don’t reuse plastics, then its advantages over paper cease to exist. Of course, the problem of permanent waste and global health consequences are issues that cannot be overlooked. The solution might lie in using plastics more wisely and re-using them as much as possible. 

(Christopher Joyce, NPR

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July 12, 2019 at 3:18 pm

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Science Policy Around the Web – June 11th, 2019

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By: Neetu Gulati, Ph.D.

Image by PublicDomainPictures from Pixabay 

People eat at least 50,000 plastic particles a year, study finds

Over 300 million tons of plastic are produced each year, and while it can take over 400 years for plastics to degrade, they can be broken down into smaller and smaller pieces, eventually leading to microplastics. Microplastics can be found all around the world: from the deepest depths of the ocean to the air around us. Now, microplastics have been found in a place much closer to home: our bodies. According to a recent study, the average person in the U.S. eats at least 50,000 particles of microplastic in a year, and also breathe in similar quantities.  And it’s known that humans ingest these particles, as microplastics have been found in human stool samples as well.

These particles are seemingly impossible to avoid; they have been found in many food and drink sources, including both tap and bottled water, beer, and seafood. Not all food and drink items have been tested, however, meaning that there are major gaps in identifying quantities of ingested microplastics. The study assessed less than 20% of caloric intake, meaning it’s possible that the amount of microplastic particles is much higher than 50,000 per year. Speaking of untested foods such as processed products, meat, dairy, and bread, Dr. Kieran Cox, lead author of the study, commented that “it is really highly likely there is going to be large amounts of plastic particles in these. You could be heading into the hundreds of thousands.”

The largest contributor of microplastics came from drinking bottled water, which contains 22 times more plastic than tap water on average. The effects of ingesting microplastics will have on human health are currently unknown. However, the study has encouraged Cox to change his own behavior in response to his findings. I definitely steer away from plastic packaging and try to avoid bottled water as much as possible,” he said.

(Damian Carrington, The Guardian

Canada Plans to Ban Single-Use Plastics, Joining Growing Global Movement

Canadian Prime Minister Justin Trudeau announced a plan to ban single-use plastics as early as 2021, expressing a wish that his children be able to play without their experiences tainted by dead birds and fish killed by pollution. In 2016, less than 10% of plastic was recycled in Canada. Trudeau noted that the nation throws away 8 billion Canadian dollars’ worth of plastic material each year, including 34 million plastic bags daily according to the Environment and Climate Change Canada.

Before the ban goes into effect, the Canadian government will analyze which plastic products should be banned, but Trudeau suggested that Canada will follow the example of the European Union, which voted to ban 10 single-use plastics earlier this year. The banned items are the most commonly found plastics on European beaches, including plates, cotton swabs, and straws. Additionally, at least 32 countries around the world and 3 US states have banned single-use plastic bags, which could also be included in Canada’s ban. 

Trudeau announced that by recycling and reusing plastic, not only would pollution be reduced, but the move could lead to the creation of over 40,000 jobs. The announcement came as Trudeau is readying for a general election at the end of the year, during which climate change and the environment are expected to be important issues.

(Dan Bilefsky, The New York Times

“Pig Ebola” is spreading uncontrollably in China and Vietnam

African swine fever, sometimes referred to as “pig Ebola”, is a highly contagious viral disease that is currently ravaging Asia’s pig industry. The current outbreak of the virus, which kills most animals it infects, started last year in China. China accounts for over half of the world’s pigs, and since the outbreak began in August, over 20% of the country’s pig herd has died, either through succumbing to the disease or to culling, according to Christine McCracken, an animal protein expert at Rabobank. She estimated that by the end of the year, China may lose up to 200 million of its roughly 440 million pig population.

Now, the disease has spread to several countries that neighbor China. From May 24 to June 6 alone, there were 163 new outbreaks, with almost 4,000 ongoing outbreaks worldwide, according to the World Organization for Animal Health. There is no current treatment or vaccine for African swine fever, the only way to prevent spread is to kill all animals that have been infected or potentially exposed, or to use strict biosecurity measures. Like China, Vietnam has also begun to cull its pig population, having killed about 2 million pigs since the outbreak began.

While the virus cannot be transmitted from pigs to humans and is not a food safety issue, it has had strong economic impacts. The Asian economy has suffered greatly, as many in the region rely on raising pigs for their livelihood, and thousands of small producers have been put out of business. A single pig can provide 200 pounds of food, so even small losses add up. While pork prices have not changed significantly due to the disease yet, it is expected that prices may skyrocket by 2020 and may affect the global pork market. 

(Vox Staff, Vox)

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June 11, 2019 at 9:32 am

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Science Policy Around the Web – February 5, 2019

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By: Neetu Gulati, Ph.D.

Source: Pixabay

Macedonia name change paves way for science cooperation with Greece

Greece and the Republic of Macedonia have been at odds for decades over the name of the latter country. After the dissolution of Yugoslavia in the early 1990s, the nation known colloquially as Macedonia was founded. However, because a region in northern Greece shares a name with the republic, Greece has disputed the country’s name, and tried to bar its entry to international organizations such as NATO and the UN. The Prespa Agreement, ratified by the Republic of Macedonia on January 11, 2019 and Greece on January 25, 2019, is set to relieve tensions by changing the disputed country name to ‘The Republic of North Macedonia,’ and the short name of ‘North Macedonia.’

The Prespa Agreement not only ends the political stand-off between the two nations, but also opens the door for strategic partnerships in many ventures, including science. While some people opposed the Agreement, scientists in both nations welcomed the change, commenting that political tensions and bureaucratic procedures will hopefully no longer hinder collaboration. “Science is done by people, and many people were affected by the mutually negative spirit among the two countries that prevailed in the past years,” commented Ioanna Chouvarda, a Greek scientist.

Many are hopeful that the name change will positively impact scientific and diplomatic ties between the two nations. A spokesperson for the Republic of Macedonia’s science ministry commented that they hope the agreement will lead to more formal scientific and technological cooperation between the two nations. Greek Alternate Minister for Research & Innovation Costas Fotakis commented, “scientific diplomacy is an effective tool that can strengthen the relations between Greece and North Macedonia, as well as the Western Balkans in general. This agreement is very timely, especially considering that several research themes are of mutual interest in both countries.” 

(Julianna Photopoulos, Nature)

The modern tragedy of fake cancer cures

The news media can sometimes sensationalize and overclaim the results of scientific advances. This is especially dangerous when results have yet to be vetted by the peer-review process, as was the case when the Dan Aridor, chairman of a small biotechnology company in Israel claimed, “we believe we will offer in a year’s time a complete cure for cancer.” The story, published by the Jerusalem Post, made bold and likely unattainable claims that the new technology would have no side-effects, be less expensive than current therapies, and be “effective from day one.” However, the new treatment has so far only been tested in a single study in mice. Furthermore, it has not yet been published and therefore has not been scrutinized or validated by other scientists in the field of cancer research. 

The claims made by Aridor may just his optimism and faith in his product, but if taken at face value they are completely unbelievable. For one thing, the original article points out that the company has not yet started clinical trials, which would take years to complete, negating the hope of a cure within a year’s time. But even those clinical trials are not likely to succeed. The odds that a cancer therapy will successfully pass clinical trials is 3-5%, according to data from MIT and the Biotechnology Industry Organization. However, even the hurdle of getting from animal studies to clinical trials is not to be overlooked, which can easily take over five years.

Cancer therapies are still worth the investment of time and money. Successful drugs like Keytruda have made a large impact on those suffering from the cancer. However, therapies do not perform the same in every patient, and ‘cancer’ is not just one disease. Often, proper dosing of cancer therapies involves a balance between the effectiveness of the treatment and the harm of the side effects. Thus, it is unlikely that a single treatment will cure all cancers without a hitch, as boldly claimed by Aridor. It is much more realistic that some treatments will work for particular types of cancers more effectively than others, with limited side effects. Speaking more conservatively about the new treatment, the CEO of the company, Ilan Morad, commented that while the company believes their therapy will cure cancer, “we still have a long way to go.”

(Matthew Herper, STAT)

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February 5, 2019 at 12:22 pm

Science Policy Around the Web – February 1, 2019

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By: Caroline Duncombe, B.S.

Source: Pixabay

How old emails hold new clues to Coca-Cola and CDC’s controversial relationship

The mission of the Centers for Diseases Control and Prevention (CDC) is to protect America from health, safety, and security threat. Yet, private emails obtained through the Freedom of Information Act reveal that a Coca-Cola Company’s influence over the federal agency refutes such a mission. Email correspondences between top CDC officials and Coca-Cola employees exposed how the soda giant tried to push the World Health Organization (WHO) to emphasize exercise over diet as the solution to the obesity epidemic via CDC’s influencing power.

            Within the 295 pages of communications from 86 emails was a request by former Coca-Cola senior vice president Alex Malaspina that WHO “should not only consider sugary foods as the only cause of obesity but consider also the lifestyle changes that have been occurring throughout the universe.” Other uncovered emails revealed that the former CDC director of Division for Heart and Disease, Barbara Bowman, gave advice to a Coca-Cola executive on potential contacts that have influence over WHO’s regional office and then director-general Dr. Margaret Chan.

            Though Coca-Cola enacted a policy in 2015 to disclose on its website its funding portfolio for scientific research and partnerships. There is little to no federal oversight over sugar and beverage industries. This is a startling fact when considering the extent of the obesity epidemic in America and the significant role that sugary drinks play in augmenting such an epidemic. After the revelation of the relationship between Coca-Cola and the CDC, discussions have increased on restricting direct contact between federal agencies and soda giants. 

(Jacqueline Howard, CNN)

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February 1, 2019 at 4:24 pm

Science Policy Around the Web – January 28, 2019

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By: Allison Cross, Ph.D.

Source: Pixabay

A Drug That Eases Miscarriages Is Difficult For Women To Get

The CDC estimates that each year in the U.S. alone, over 1 million women suffer miscarriages during the first trimester of pregnancy.  When a woman finds out that her pregnancy is not viable, she is usually given three options: wait for the miscarriage to occur on its own, take medicine to induce the miscarriage, or undergo a surgical procedure (known as a D&C) to remove the contents of the uterus.  For women who want to avoid a surgical procedure but do not want to wait for the miscarriage to occur on its own, the medically induced miscarriage is a favored option. 

Misoprostol is the medication currently prescribed in the U.S. to induce miscarriage.  Although this medication works for many, a single dose of the medicine is ineffective for about 30% of women.  When the medicine is ineffective, women end up either returning to their doctor for another dose or moving forward with surgery.  However, a recent studyin the New England Journal of Medicine found that combining the currently used medication, misoprostol, with mifepristone is more effective than misoprostol alone in inducing miscarriage.  The study followed 300 women experiencing first trimester pregnancy lose and found the combination of misoprostol and mifepristone increased the chance of successfully inducing miscarriage to 90%, a 14% increase over misoprostol alone. 

Although this new study may provide hope for women suffering an early pregnancy loss and wishing to avoid surgical intervention, most doctors in the U.S. are unable to prescribe mifepristone due to current FDA regulations.  Mifepristone was approved by the FDA in 2000 but is currently regulated under what is known as a Risk Evaluation and Mitigation Strategy (REMS).  The REMS designation means that the FDA can restrict how and where the medication is distributed.  For mifepristone, the REMS restriction prohibits its availability in commercial pharmacies; the drug can only be distributed from clinics or hospitals designated as mifepristone suppliers.  

As mifepristone is commonly used for abortions, some argue that the REMS designation for the drug is driven by political motives rather than due to concerns about drug safety.  Currently, medical societies including The American College of Obstetricians and Gynecologists, the American Academy of Family Physicians and the American Medical Association are trying to overturn the FDA REMS classification of mifepristone.  

(Mara Gordon and Sarah McCammon, NPR)

Ebola Vaccine Supplies Are Expected to Last

The Democratic Republic of Congo (DRC) is currently facing a devasting Ebola outbreak and recently reported 689 confirmed and probable infections and 422 deaths. However, the World Health Organization (WHO) recently announced that they expect to have adequate supplies of an experimental Ebola vaccine to stop the outbreak. 

The experimental vaccine, known as V920, is made by Merck and was first shown to be highly effective in a clinical trial during the West African Ebola crisis of 2014-2016. In the current outbreak, Dr. Peter Salama, WHO’s deputy director-general of emergency preparedness and response, has reported that the vaccine is “highly, highly efficacious”, showing a efficacy rate well above 90%.  

After the West African Ebola crisis of 2014-2016, Merck made an agreement with the WHO and with Gavi, the Vaccine Alliance to maintain a stockpile of 300,000 doses of the vaccine at all times while they worked to get the vaccine licensed. As most Ebola epidemics have been controlled after less than 100 cases, the 300,000-dose stockpile seemed more than sufficient. However, tens of thousands of doses of the vaccine have already been used with the recent outbreak in the DRC, raising concerns that the supply would be depleted.  

Merck’s team lead for the Ebola vaccine project, Beth-Ann Coller, confirmed that in addition to the 100,000 doses of the vaccine that the company has already sent to the WHO, they still have about 300,00 doses on hand. However, due to the uncertainly of around the outbreak, Coller said the company is also exploring options to expand the stockpile further. 

(Helen Branswell, STAT)

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Written by sciencepolicyforall

January 29, 2019 at 3:18 pm