Date:
September 28, 2017

Source:
Uppsala University

Summary:
A genomic analysis of ancient human remains from KwaZulu-Natal revealed that southern Africa has an important role to play in writing the history of humankind.

 

Dr. Helena Malmström conducting on-site sampling of bone matrial in a mobil sampling lab.
Credit: Uppsala University

 

 

A genomic analysis of ancient human remains from KwaZulu-Natal revealed that southern Africa has an important role to play in writing the history of humankind. A research team from Uppsala University, Sweden, the Universities of Johannesburg and the Witwatersrand, South Africa, presents their results in the September 28th early online issue of Science.

The team sequenced the genomes of seven individuals who lived in southern Africa 2300-300 years ago. The three oldest individuals dating to 2300-1800 years ago were genetically related to the descendants of the southern Khoe-San groups, and the four younger individuals who lived 500-300 years ago were genetically related to current-day South African Bantu-speaking groups. “This illustrates the population replacement that occurred in southern Africa,” says co-first author Carina Schlebusch, population geneticist at Uppsala University.

The authors estimate the divergence among modern humans to have occurred between 350,000 and 260,000 years ago, based on the ancient Stone Age hunter-gatherer genomes. The deepest split time of 350,000 years ago represents a comparison between an ancient Stone Age hunter-gatherer boy from Ballito Bay on the east coast of South Africa and the West African Mandinka. “This means that modern humans emerged earlier than previously thought,” says Mattias Jakobsson, population geneticist at Uppsala University who headed the project together with Stone Age archaeologist Marlize Lombard at the University of Johannesburg.

The fossil record of east Africa, and in particular the Omo and Herto fossils have often been used to set the emergence of anatomically modern humans to about 180,000 years ago. The deeper estimate for modern human divergence at 350,000-260,000 years ago coincides with the Florisbad and Hoedjiespunt fossils, contemporaries of the small-brained Homo naledi in southern Africa. “It now seems that at least two or three Homo species occupied the southern African landscape during this time period, which also represents the early phases of the Middle Stone Age,” says Marlize Lombard. It will be interesting to see in future if we find any evidence of interaction between these groups.

“We did not find any evidence of deep structure or archaic admixture among southern African Stone Age hunter-gatherers, instead, we see some evidence for deep structure in the West African population, but that affects only a small fraction of their genome and is about the same age as the deepest divergence among all humans,” says Mattias Jakobsson.

The authors also found that all current-day Khoe-San populations admixed with migrant East African pastoralists a little over a thousand years ago. “We could not detect this widespread East African admixture previously since we did not have an un-admixed San group to use as reference. Now that we have access to ancient DNA of people who lived on the landscape before the East African migration, we are able to detect the admixture percentages in all San groups. The admixture percentages in the Khoekhoe, historically identified as pastoralists, are higher than previously estimated,” says Carina Schlebusch.

Of the Iron Age individuals, three carry at least one Duffy null allele, protecting against malaria, and two have at least one sleeping-sickness-resistance variant in the APOL1 gene. The Stone Age individuals do not carry these protective alleles. “This tells us that Iron Age farmers carried these disease-resistance variants when they migrated to southern Africa,” says co-first author Helena Malmström, archaeo-geneticist at Uppsala University.

Marlize Lombard said that “archaeological deposits dating to the time of the split by 350,000-260,000 years ago, attest to South Africa being populated by tool-making hunter-gatherers at the time. Although human fossils are sparse, those of Florisbad and Hoedjiespunt are seen as transitional to modern humans.” These fossils may therefore be ancestral to the Ballito Bay boy and other San hunter-gatherers who lived in southern Africa 2000 years ago.

The transition from archaic to modern humans might not have occurred in one place in Africa but in several, including southern Africa and northern Africa as recently reported. “Thus, both palaeo-anthropological and genetic evidence increasingly points to multiregional origins of anatomically modern humans in Africa, i.e. Homo sapiens did not originate in one place in Africa, but might have evolved from older forms in several places on the continent with gene flow between groups from different places,” says Carina Schlebusch.

“It is remarkable that we can now sequence entire genomes of ancient human remains from tropical areas, such as the southeast coast of South Africa,” says Helena Malmström. This is promising for our several ongoing investigations in Africa.

Cumulatively these findings shed new light on our species’ deep African history and show that there is still much more to learn about our process of becoming modern humans and that the interplay between genetics and archaeology has an increasingly important role to play.

Story Source:

Materials provided by Uppsala UniversityNote: Content may be edited for style and length.


Journal Reference:

  1. Carina M. Schlebusch, Helena Malmström, Torsten Günther, Per Sjödin, Alexandra Coutinho, Hanna Edlund, Arielle R. Munters, Mário Vicente, Maryna Steyn, Himla Soodyall, Marlize Lombard, Mattias Jakobsson. Southern African ancient genomes estimate modern human divergence to 350,000 to 260,000 years agoScience, 28 Sep 2017 DOI: 10.1126/science.aao6266

 

Source: Uppsala University. “Modern humans emerged more than 300,000 years ago new study suggests.” ScienceDaily. ScienceDaily, 28 September 2017. <www.sciencedaily.com/releases/2017/09/170928142016.htm>.

Study is first to find cell volume can influence the future role of stem cells, regardless of environment

Date:
September 26, 2017

Source:
University at Buffalo

Summary:
Adding or removing water from a stem cell can change the destiny of the cell to either pre-fat cells or pre-bone cells, researchers have discovered in a new study.

 

Top images (A): Illustrates the development of stem cells on hydrogel, a soft substrate, to pre-bone cells after the removal of water. Bottom images (B): Depicts the development of stem cells on glass, a hard substrate, to pre-fat cells after the addition of water.
Credit: Courtesy of the researchers

 

 

Adding or removing water from a stem cell can change the destiny of the cell, researchers have discovered in a new study published in the Proceedings of the National Academy of Sciencesof the United States of America (PNAS).

The research found that altering the volume of a cell changed its internal dynamics, including the rigidness of the matrix lining the outer surface. In stem cells, removing water condenses the cell, influencing the stem cells to become stiff pre-bone cells, while adding water causes the cells to swell, forming soft pre-fat cells.

Researchers have long understood that stem cells are influenced by the cells around them, picking up cues on what their function should be based on the stiffness of the matrices of neighboring cells.

The results, however, confirm that nature plays as much of a role as nurture in stem cell behavior and development.

“The findings from this study add a fascinating new tool to our understanding and utilization of stem cell biology for regenerative medicine,” says Praveen Arany, DDS, PhD, co-author and assistant professor in the Department of Oral Biology in the University at Buffalo School of Dental Medicine.

The study was led by Ming Guo, PhD, d’Arbeloff Assistant Professor in the Department of Mechanical Engineering at the Massachusetts Institute of Technology; and David Weitz, PhD, Mallinckrodt Professor of Physics and of Applied Physics in the John A. Paulson School of Engineering and Applied Sciences at Harvard University.

“For the first time, we’re beginning to understand the importance of cell volume and cellular water content in the mechanical properties and physiological functions of cells,” says Guo, who began the research as a graduate student in Weitz’s lab at Harvard.

The Line Between Bone and Fat

The research originally sought to understand the effects of volume on a cell’s characteristics and functions. Cell volume is highly regulated and changes frequently over the course of a cell’s life, increasing as the cell grows and decreasing when it divides.

These changes in volume are a result of variations in the amount of protein, DNA and other materials within the cell, though they mostly remain constant. But cells can also experience rapid and extreme changes in size and density through the absorption or release of water, spreading or shrinking in as little as 20 minutes.

By increasing or decreasing the volume of cells by 20 percent, the investigators found that the cells experienced several internal changes, including in gene expression and stiffness.

Knowing the role cell stiffness plays in the development of stem cells, the researchers began to wonder if cell volume could affect their fate as well.

To test the premise, investigators placed stem cells at their normal volume in a hardened hydrogel substrate to simulate the rigidness of bone cells. After one week, a large portion of the stem cells developed into pre-bone cells.

The experiment was repeated with a softened hydrogel substrate. In the softer environment, there was a significant decrease in the number of stem cells that became pre-bone cells. However, when water was removed from the cells to decrease their volume by 20 percent, the number of stem cells that became pre-bone cells increased, despite being in the softer substrate.

A similar experiment was conducted using glass. Researchers placed stem cells on glass to simulate a stiffer environment and found that few of the cells developed into pre-fat cells. It was not until the volume of the stem cells was increased by 20 percent that a spike in the formation of fat cells was found.

The investigators discovered that changing the volume of the cells caused them to behave similarly to as if they were under environmental pressures.

“The surprising thing about these experiments is the observation that volume seems to be related to so much about the cell. It seems to dictate the cell stiffness as well as the cell fate,” says Weitz, also a core faculty member of the Wyss Institute for Biologically Inspired Engineering and director of the Materials Research Science and Engineering Center at Harvard.

“These observations may also have implications in external means of monitoring cell fate, which may be important for future biotech applications.”

Future studies are needed to examine the effects of varied changes in volume, as well as if cell volume or external cues are the dominating factor in the fate of stem cells.

The Future of Regenerative Medicine

Stem cells sit at the forefront of regenerative medicine, providing researchers and clinicians with the potential to repair or replace damaged tissue and organs.

With the ability to develop into any type of specialized cell — from a muscle cell to a red blood or brain cell — stem cells hold the potential to treat various diseases and conditions, from heart disease to tooth loss. Bone marrow transplantation, one form of stem cell therapy, is already in widespread use.

Stem cells may also aid in drug development and the understanding of how cancer and birth defects occur.

Learning what causes differentiation among these cells will help researchers generate methods that influence their behavior and, ultimately, develop new therapies.

Aside from physical cues such as cell stiffness or volume, stem cell differentiation can be influenced by a number of biological factors, pharmaceutical drugs or biophysical agents, such as light, ultrasound and radio frequencies.

Story Source:

Materials provided by University at Buffalo. Original written by Marcene Robinson. Note: Content may be edited for style and length.


Journal Reference:

  1. Ming Guo, Adrian F. Pegoraro, Angelo Mao, Enhua H. Zhou, Praveen R. Arany, Yulong Han, Dylan T. Burnette, Mikkel H. Jensen, Karen E. Kasza, Jeffrey R. Moore, Frederick C. Mackintosh, Jeffrey J. Fredberg, David J. Mooney, Jennifer Lippincott-Schwartz, and David A. Weitz. Cell volume change through water efflux impacts cell stiffness and stem cell fatePNAS, September 2017 DOI: 10.1073/pnas.1705179114

 

Source: University at Buffalo. “Amount of water in stem cells can determine its fate as fat or bone: Study is first to find cell volume can influence the future role of stem cells, regardless of environment.” ScienceDaily. ScienceDaily, 26 September 2017. <www.sciencedaily.com/releases/2017/09/170926125131.htm>.

Date:
September 26, 2017

Source:
Ulsan National Institute of Science and Technology(UNIST)

Summary:
Engineers have introduced a new advanced energy harvesting system, capable of generating electricity by simply being attached to clothes, windows, and outer walls of a building.

 

 

A recent study, led by Professor Kyoung Jin Choi in the School of Materials Science and Engineering at UNIST has introduced a new advanced energy harvesting system, capable of generating electricity by simply being attached to clothes, windows, and outer walls of a building.

This new device is based on a temperature difference between the hot and cold sides. The temperature difference can be increased as high as 20.9 °C, which is much higher than the typical temperature differences of 1.5 to 4.1 °C of wearable thermoelectric generators driven by body heat. The research team expects that their wearable solar thermoelectric generator proposes a promising way to further improve the efficiency by raising the temperature difference.

Energy harvesting is a diverse field encompassing many technologies, which involve a process that captures small amounts of energy that would otherwise be lost as heat, light, sound, vibration, or movement. A thermoelectric generator (TEGs) refers to a device that converts waste heat energy, such as solar energy, geothermal energy, and body heat into additional electrical power.

There has been a great increase in the study of wearable thermoelectric (TE) generators using the temperature difference between the body heat and surrounding environment. However, one of the main drawbacks of wearable TEG techniques driven by body heat was that such temperature difference is only 1 — 4 degrees Celsius and this has hindered further commercialization.

The research team solved this low temperature difference faced by conventional wearable TEGs by introducing a local solar absorber on a PI substrate. The solar absorber is a five-period Ti/MgF2 superlattice, in which the structure and thickness of each layer was designed for optimal absorption of sunlight. This has increased the temperature difference as high as 20.9 °C, which is the highest value of all wearable TEGs reported to date.

“Through this study, we have secured a temperature difference with the ten-fold increase from the conventional wearable solar thermoelectric generators,” says Yeon Soo Jung in the Graduate School of Materials Science and Engineering at UNIST. “Since the output of a TE generator is proportional to the square root of the temperature difference, one can significantly increase the output with the help of this technology.”

In this study, Professor Choi and his team designed a noble wearable solar thermoelectric generator (W-STEG) by integrating flexible BiTe-based TE legs and sub-micron thick solar absorbers on a polymide (PI) substrate. The TE legs were prepared by dispenser printing with an ink consisting of mechanically alloyed BiTe-based powders and an Sb2Te3-based sintering additive dispersed in glycerol. They report that a W-STEG comprising 10 pairs of p-n legs has an open-circuit voltage of 55.15 mV and an output power of 4.44 μW when exposed to sunlight.

“Our new werable STEG is expected to be useful in various applications, such as in self-powered wearable electronic devices,” says Professor Choi. “It will also serve as a catalyst to further improve the future wearable electronic technology market.”

Story Source:

Materials provided by Ulsan National Institute of Science and Technology(UNIST)Note: Content may be edited for style and length.


Journal Reference:

  1. Yeon Soo Jung, Dea Han Jeong, Sung Bum Kang, Fredrick Kim, Myeong Hoon Jeong, Ki-Suk Lee, Jae Sung Son, Jeong Min Baik, Jin-Sang Kim, Kyoung Jin Choi. Wearable solar thermoelectric generator driven by unprecedentedly high temperature differenceNano Energy, 2017; DOI: 10.1016/j.nanoen.2017.08.061

 

Source: Ulsan National Institute of Science and Technology(UNIST). “Wearable solar thermoelectric generator created.” ScienceDaily. ScienceDaily, 26 September 2017. <www.sciencedaily.com/releases/2017/09/170926105530.htm>.

Treating pregnant women before infection may protect fetuses from Zika

Date:
September 25, 2017

Source:
Washington University School of Medicine

Summary:
The same countries hard hit by Zika virus — which can cause brain damage in babies infected before birth — are also home to dengue virus. Researchers now report that they have found an antibody that protects against both viruses. These findings, in mice, could be a step towards an antibody-based preventative drug to protect fetuses from brain damage, while also protecting their mothers from both Zika and dengue disease.

 

An antibody administered soon after infection with Zika virus protected the fetuses of pregnant mice (left), while the fetuses in infected mice that did not receive the antibody withered away (right). Researchers have identified an antibody that protects against both dengue and Zika disease, a first step toward an antibody-based preventive drug to protect fetuses from brain damage caused by Zika, while also protecting their mothers from Zika and dengue.
Credit: Estefania Fernandez

 

 

Brazil and other areas hardest hit by the Zika virus — which can cause babies to be born with abnormally small heads — are also home to dengue virus, which is spread by the same mosquito species.

A new study led by researchers at Washington University School of Medicine in St. Louis shows that an antibody that protects against dengue virus is also effective against Zika in mice.

Antibodies remain in the bloodstream for weeks, so one or a few doses of an antibody-based drug given over the course of a woman’s pregnancy potentially could protect her fetus from Zika, with the added benefit of protecting her from both Zika and dengue disease, the researchers said. Dengue causes high fever, severe headaches, and joint and muscle pain in children and adults but does not directly harm fetuses.

“We found that this antibody not only neutralizes the dengue virus but, in mice, protects both adults and fetuses from Zika disease,” said Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine and the study’s senior author.

The study is published Sept. 25 in Nature Immunology.

Since dengue and Zika are related viruses, the researchers reasoned that an antibody that prevents dengue disease may do the same for Zika. Diamond and graduate student Estefania Fernandez collaborated with Gavin Screaton, MD, DPhil, of Imperial College London, who had generated a panel of human anti-dengue antibodies years before.

The scientists infected nonpregnant adult mice with Zika virus and then administered one of the anti-dengue antibodies one, three or five days after infection. For comparison, another group of mice was infected with Zika virus and then given a placebo. Within three weeks of infection, more than 80 percent of the untreated mice had died, whereas all of the mice that received the anti-dengue antibody within three days of infection were still alive, and 40 percent of those that received the antibody five days after infection survived.

To find out whether the antibody also could protect fetuses from infection, the researchers infected female mice on the sixth day of their pregnancies with Zika virus and then administered a dose of antibody or a placebo one or three days later.

On the 13th day of gestation, the amount of Zika’s genetic material was 600,000 times lower in the placentas and 4,900 times lower in the fetal heads from the pregnant mice that were treated one day after infection, compared with mice that received the placebo. However, administering the antibody three days after infection was less effective: It reduced the amount of viral genetic material in the fetal heads nineteenfold and in the placentas twenty-threefold.

These findings suggest that for the antibody to effectively protect fetuses from Zika infection, it must be administered soon after infection. Such a goal may be unrealistic clinically because women rarely know when they get infected.

However, giving women the antibody as soon as they know they are pregnant could provide them with a ready-made defense against the virus should they encounter it. Antibody-based drugs have been used for decades to provide temporary protection against infectious diseases such as rabies when there is no time to vaccinate or, as in the case of Zika, when there is no vaccine available.

The key to using this antibody as a preventive drug would be to make sure that antibody levels in a woman’s bloodstream stay high enough to protect her fetus for the duration of her pregnancy.

Diamond and colleagues are working on identifying how much antibody a pregnant woman would need to ensure that her fetus is protected from Zika. They also are exploring ways to extend the antibody’s half-life in the blood, to reduce the number of times it would need to be administered.

Having anti-dengue antibodies circulating in the bloodstream for months on end poses a risk, though, because antibodies that protect against one strain of dengue virus sometimes worsen symptoms if a person is infected by another dengue strain.

To avoid the possibility of accidentally aggravating an already very painful disease, the researchers mutated the antibody in four spots, making it impossible for the antibody to exacerbate dengue disease.

“We mutated the antibody so that it could not cause antibody enhancement of dengue infection, and it was still protective,” said Diamond, who is also a professor of pathology and immunology, and of molecular microbiology. “So now we have a version of the antibody that would be therapeutic against both viruses and safe for use in a dengue-endemic area, because it is unable to worsen disease.”

Story Source:

Materials provided by Washington University School of Medicine. Original written by Tamara Bhandari. Note: Content may be edited for style and length.


Journal Reference:

  1. Estefania Fernandez, Wanwisa Dejnirattisai, Bin Cao, Suzanne M Scheaffer, Piyada Supasa, Wiyada Wongwiwat, Prabagaran Esakky, Andrea Drury, Juthathip Mongkolsapaya, Kelle H Moley, Indira U Mysorekar, Gavin R Screaton, Michael S Diamond. Human antibodies to the dengue virus E-dimer epitope have therapeutic activity against Zika virus infectionNature Immunology, 2017; DOI: 10.1038/ni.3849

 

Source: Washington University School of Medicine. “Antibody protects against Zika and dengue, mouse study shows: Treating pregnant women before infection may protect fetuses from Zika.” ScienceDaily. ScienceDaily, 25 September 2017. <www.sciencedaily.com/releases/2017/09/170925132912.htm>.

eClinical Forum Meetings in Europe and the USA

 

Next week, Les Jordan, Vice President, Chief Product Evangelist at Target Health will be at the eClinical Forum European Meeting, and will be presenting on Agile Software Development. The meeting, hosted by Bayer, will be held at the Steigenberger Hotel in Berlin, Germany on 26-28 September 2017.

 

The objectives of the meeting are to:

 

1. Leverage the knowledge of eClinical Forum members to remain up-to-date on current thinking and to explore emerging technology, process, people and regulatory trends.

 

2. Drive performance by developing an unrivalled insight into global best practices, risks and opportunities.

 

3. Design the future of eClinical Research by working with peers to develop leading-edge visions and implementable strategies.

 

4. Build a network with global experience and insight for beyond-the-workshop interaction.

A draft agenda will be issued shortly.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

QUIZ

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USA Threatened By More Frequent Flooding; East Coast is Slowly Sinking into the Sea

U.S. military rescue workers helping American flood victims.  This image is a work of a U.S. Army soldier or employee, taken or made as part of that person’s official duties. As a work of the U.S. federal government, the image is in the public domain.

 

 

Editor’s note: We bring you this climate change study, primarily because the increased global temperatures and flooding, of climate change also bring an increase of diseases. With warmth and many additional pools of water, disease carrying mosquitoes (as well as many other pests) will be much more abundant. Just as we were not prepared for the millions of climate change refugees from the 2017 super hurricanes, alone, we won’t be ready for millions of Americans with diseases, made worse by fast-moving changes in climate.

 

Climate change should no longer be a “blame-game.“ It’s going to affect us all. Our home, planet Earth has become a theater of survival. This global issue requires the cooperation of every country and every world citizen, if anyone is going to survive on the world stage, now on a fast track toward flooding us out with unharnessed hurricanes, burning and smoking us out with uncontrolled forest fires, choking us out with air pollution, smothering us with life threatening rising temperatures, killing us with new and/or more virulent diseases.

 

We should be talking, as one planetary network, on how to collaborate with life-saving research, like sucking CO2 out of the atmosphere, NOW, and maybe shooting it off into the sun (how about shooting the trillions of tons of human plastic garbage that’s polluting our oceans, into the sun), or finding a creative way to utilize the extra CO2, here on earth. We, people of the earth, need to act fast; and right now! Some scientists are saying that we might not be able to recover, to return to the life style Americans are accustomed to.

 

For people not aware of the disasters of climate change, it’s our job to make sure they’re educated. This is not a political fight, this is a human fight.

We’re all in this together, folks

 ——-Joyce Hays

 

The East Coast of the United States is threatened by more frequent 1) ___ in the future. This is shown in a recent study by the Universities of Bonn, South Florida, and Rhode Island. According to this study, the states of Virginia, North Carolina, and South Carolina are most at risk. Their coastal regions are being immersed by up to three millimeters per year — among other things, due to human intervention. The work is published in the journal Scientific Reports by the Nature Publishing Group. Cities such as Miami on the East Coast of the USA are being affected by flooding more and more frequently. The causes are often not hurricanes with devastating rainfall such as Katrina, or the recent 2017 hurricanes Harvey, Irma, Jose, Maria. On the contrary: flooding (especially at high 2) ___) even occurs on sunny, relatively calm days. It causes damage to houses and roads and disrupts traffic, yet does not cost any people their lives. It is thus also known as ?nuisance flooding’. During high tide in Miami, Florida, fish have been seen in the flooded streets. And this nuisance is set to occur much more frequently in the future. At least researchers from the Universities of Bonn, South Florida, and Rhode Island show this in their study. The international team evaluated data from the East Coast of America, including GPS and satellite measurements. The data shows that large parts of the coastal region are slowly yet steadily sinking into the 3) ___ Ocean.

 

“There are primarily two reasons for this phenomenon,“ explains Makan A. Karegar from the University of South Florida, currently a guest researcher at the Institute of Geodesy and Geoinformation at the University of Bonn. “During the last ice age around 20,000 years ago, large parts of Canada were covered by an 4) ___ sheet. This tremendous mass pressed down on the continent.“ Some areas of Earth’s mantle were thus pressed sideways under the ice, causing the coastal regions that were free of ice to be raised. “When the ice sheet then melted, this process was reversed,“ explains Karegar. “The East Coast has thus been sinking back down for the last few thousand years.“ This geological effect explains the submerging of the coastal regions, but only in part. In the last decade, the area between 32 and 38 degrees latitude has been sinking more quickly than in the previous millennia — in some cases, by more than three millimeters a year. The melting of the ice 5) ___ is responsible for a maximum of a third of this. The authors assume that it is caused by the significant use of groundwater in the corresponding region. 6) ___ allows the land mass to swell up to some degree — similar to carbon dioxide bubbles in cake mix. “When groundwater is removed, the land mass can be compressed more greatly,“ said Karegar. “It practically collapses into itself and thus sinks even more.“ “Depending on the distance from the sea, the creation of reservoirs can also contribute to the sinking or even the raising of the coastal region,“ said Prof. J?rgen Kusche from the Institute of Geodesy and Geoinformation. “This effect was taken into account with the help of satellite 7) ___

 

Many cities on the East Coast of America were founded at the end of the 16th or start of the 17th centuries. The researchers have calculated that these cities lie at least 45 centimeters lower today than back then, solely due to the glacier effect. In recent years, they have even been sinking much more rapidly in some places due to the removal of groundwater. A further factor is the rising sea level due to climate change, an effect that now also totals more than three millimeters per year and is responsible for another 15 centimeters of submerged 8) ___. This increase is set to gain much more momentum in the 9) ___. “Even if the removal of groundwater is reduced, the number of floods will thus continue to increase,“ predicts Karegar. “The sums of money that need to be spent to rectify the damage associated with this will also increase significantly. One should, therefore, assume that the USA has a vested interest in combatting climate 10) ___ with all its resources.“

 

Source: University of Bonn; Makan A. Karegar, Timothy H. Dixon, Rocco Malservisi, J?rgen Kusche, Simon E. Engelhart. Nuisance Flooding and Relative Sea-Level Rise: The Importance of Present-Day Land Motion. Scientific Reports, 2017; 7 (1) DOI: 10.1038/s41598-017-11544-y

 

 

Intelligent discussion of climate change: Fareed Zakaria and Dr. Neil deGrasse Tyson.

“This (all the September 2017 hurricanes) is going to affect our economy greatly. We might not be able to recover“

 

ANSWERS: 1) flooding; 2) tide; 3) Atlantic; 4) ice; 5) sheet; 6) Water; 7) measurement; 8) land; 9) future; 10) change

 

History of FDA and Disaster Relief

FDA Building 31 (left photo) houses the Office of the Commissioner and the Office of Regulatory Department of Health and Human Services. The agency consists of fourteen Centers and Offices. FDA Building 51 (right photo) houses the Center for Drug Evaluation and Research. The FDA campus is located at 10903 New Hampshire Ave., Silver Spring, MD 20993Photo credits: The U.S. Food and Drug Administration – FDA Bldg 31 – Exterior, Public Domain; Wikipedia Commons

 

President Abraham Lincoln signed into law an act of Congress establishing the United States Department of Agriculture in 1862. The Act of Incorporation, signed by President Abraham Lincoln on March 3, 1863, created the National Academy of Sciences and named 50 charter members. Many of the original NAS members came from a scientific informal network of mostly physical scientists, begun around 1850, working in the vicinity of Cambridge, Massachusetts. These two great scientific agencies, paved the way for the Food and Drug Administration, which emerged over time, from the USDA, founded by the prescient President Abraham Lincoln. Around the world, these U.S. agencies were hailed as a great step forward in government recognition of the role of science in American society. The United States has always been a global leader of scientific solutions.

 

The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in the U. S. federal government. Its origins can be traced back to the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862. Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs. Harvey Washington Wiley, Chief Chemist of the Bureau of Chemistry in the Department of Agriculture, had been the driving force behind this law and headed its enforcement in the early years, providing basic elements of protection that consumers had never known before that time.

 

A rectangular shape box with a man battling a skelton (left) and on the right same picture but in the form of a stamp. Photo source: fda.gov

 

The U. S. Post Office recognized the 1906 Act as a landmark of the 20th century when it released this stamp, the design of which was based on a 19th century patent medicine trading card.

 

The FDA and its responsibilities have undergone a metamorphosis since 1906. Similarly, the marketplace itself, the sciences undergirding the products the agency regulates, and the social, cultural, political, and economic changes that have formed the context for these developments, all have witnessed upheavals over the past century. Yet the core public health mission of the agency remains now as it did then. This web site features a variety of portals that offer insight into these changes, from overviews on how consumer protection laws evolved, to case studies that explore and interpret the agency’s work and policies. In addition, the visitor will find links to key related web sites as well as citations to valuable sources to help understand the history of FDA.

 

Several people gathered around a table examining items. FDA Inspector William Ford is at the center of activity in dealing with the 1937 flooding of the Ohio River and its impact on regulated commodities. Photo credit: fda.gov

 

Images from FDA History

The FDA History Office has mounted a series of 200 posters around the headquarters campus in Silver Spring, Maryland, illustrating the evolution of FDA’s work to protect and promote the public health. These include posters from public health campaigns, images of FDA inspectors, analysts, and others at work, and the commodities the agency regulates. These photos are also available for public access on FDA’s Flickr photo-stream disclaimer icon

 

Click here to view FDA photos with captions, that capture the history of this important agency

 

The following is a statement from FDA about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms.

 

September 14, 2017

 

Statement

 

This is the first time that two category 4 storms have hit the U.S. back-to-back, and the effects have been devastating. At FDA we have a large team working on providing assistance to those affected by these storms, including American farmers who have suffered crop losses. You’ll be hearing a lot from us in the coming weeks, as we do our part to help people continue to recover from these tragic events. Today, we’re providing more information for farmers and food producers who’ve been impacted by these storms, and in particular, the proper handling of crops that have been exposed to floodwaters.

 

The FDA has longstanding experience responding to flooding and storms. We play an integral role, working with states, in protecting the safety of the food supply – both human and animal food. We recognize that these hurricanes have presented unique challenges for farmers, and the FDA is committed to work with growers, as well as with our federal and state partners, to ensure that the food we serve our families is safe and that consumers have confidence in the products they consume.

 

We’ve been in close discussion with farmers, consumer representatives, and state officials regarding concerns about how crops may be impacted by these storms. One crop for which there have been a high number of inquiries is rice. This owes, in particular, to the impact of Hurricane Harvey on the large rice crop in Texas. I want to make it clear that the FDA has not issued a ban on rice or any other food crops. Rice grown in normal conditions and rice that has not been exposed to contaminated floodwaters from the recent hurricanes may enter commerce. Also, rice and other crops that were harvested and stored safely before storms hit should not be considered impacted by these events. The documents we’re issuing today, as well as the direct consultations we’re continuing to have, with state officials and with farmers directly, are aimed at providing our most up-to-date, science-based information on which crops can enter commerce without creating risks to consumers or animals who may be fed crops as part of animal feed.

 

However, we recognize that crops have been and will continue to be impacted in a variety of ways by these storms. There have been substantial crop losses from both storms. Crops may be submerged in flood water, exposed to contaminants, or susceptible to mold. Some of the major concerns for crop safety are heavy metals, chemical, bacterial, and mold contamination. In many cases, it is challenging to determine what contaminants are in crops that were submerged by floodwaters. Both human and animal food must meet well-established safety requirements. FDA has experts that are working closely with state regulators and directly with producers to address questions and concerns.

 

The FDA takes seriously our obligation to provide guidance to support farmers and food producers, who are responsible for the safety of their products. Many of these resources are already available on FDA’s website. Others will be revised in the coming days and issued directly by the agency, as part of our ongoing effort to provide more timely advice for our stakeholders.

 

The FDA staff is continuing to work with USDA, state partners, extension services and other stakeholders to help producers as they work to evaluate the safety of their crops. We recognize that in many cases, it is those on the ground who can best advise farmers and help producers evaluate specific concerns and conditions. We have experts in the affected regions who can help provide direct assistance and we are taking additional steps to support recovery efforts. We also understand that state Departments of Agriculture may have specific requirements regarding any attempt to clean, process, test, use or sell crops for human or animal food.

 

FDA scientists recently had the opportunity to tour farms and packing facilities in Georgia. That trip reminded that farms are different than the other entities FDA regulates. Farms are not just a place of business. Many are homes. Many farms have been in families for generations. As a result, the impact of floods on farms and farmers is especially concerning to FDA. It has hit many farmers hard, destroying their homes and their livelihoods. FDA is leaning forward in our efforts to make sure that we’re providing timely assistance, and that our advice on crop safety reflects our most up-to-date, science based analysis. Our primary mission is the protection and promotion of the public health. We’re committed to making sure food is safe for consumers. But we recognize there are hard questions that must be quickly answered about crops affected by these storms, or else crops that might be safe — because they were not exposed to contaminated floodwaters — could age past their point of use. We recognize the tremendous impact this storm had on region’s farming families. We’re working diligently to provide them with timely guidance. FDA is committed to doing its part to help farmers get back to work.

 

More detailed information on the impacts of flooding on human and animal crop uses can be found on the FDA website. Also available is general information on evaluating the safety of food and animal food crops exposed to flood waters. In addition, you can find Q & A on crops harvested from flooded fields intended for animal food.

The FDA, is an agency within the U.S. Department of Health and Human Services, that protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

FDA White Oak Campus in Silver Spring, Maryland. Photo credit: FDA.gov

 

Sources: https://www.fda.gov/aboutfda/whatwedo/history/; Wikipedia

 

Immune Cells May Heal Bleeding Brain After Strokes

 

Accounting for 10-15% of all strokes, intracerebral hemorrhages happen when blood vessels rupture and leak blood into the brain, often leading to death or long-term disability. Chronic high blood pressure is the leading risk factor for these  types of strokes. The initial phase of damage appears to be caused by the pressure of blood leaking into the brain. Over time, further damage may be caused by the accumulation of toxic levels of blood products, infiltrating immune cells, and swelling. Neutrophils are born in bone marrow and carry chemicals in hundreds of densely filled packets called granules, which look like dark spots under a microscope. Typically, when the body senses bacteria or an injury, neutrophils rush to the invasion site and release germ killing chemicals from the granules. This appears to happen minutes after a hemorrhagic stroke.

 

According to the NIH, decades of research suggest that neutrophils are some of the earliest immune cells to respond to a hemorrhage, and that they may both harm and heal the brain. In the present study, published in Nature Communication (20 September 2017), it was found that interleukin-27 (IL-27), a protein that controls the activity of immune cells, may shift the role of neutrophils from harming the brain to helping with recovery. Results showed that injections of IL-27 after a hemorrhage helped mice recover and that days after the strokes, the treated mice had better mobility, including walking, limb stretching and navigating holes in a floor. In contrast, injections of an antibody that blocked natural IL-27 activity slowed recovery. At autopsy, the brains of the mice treated with IL-27 also showed less damage. They had less swelling around the hemorrhages and lower levels of iron and the blood protein hemoglobin, both of which are toxic at high levels.

 

Based on the results of the study, the authors hypothesized that after a hemorrhagic stroke, the brain secretes high levels of IL-27, which leads to a second wave of neutrophils arriving with granules filled with higher amounts of healing molecules. IL-27 levels were elevated in the brain and blood of the mice an hour after hemorrhages, and stayed high for three days, peaking at 24 hours. Further experiments suggested that brain cells called microglia produced the IL-27 in response to the presence of red blood cells.

 

Once released, IL-27 molecules appeared to travel to the bones of the mice, infiltrated the marrow, and changed the role newborn neutrophils played in response to a stroke. When the authors extracted newborn neutrophils from the bones of mice and treated and them with IL-27, IL-27 raised the activity of genes associated with healing, especially lactoferrin, while reducing the activity of genes associated with killing cells. Conversely, treating mice with an IL-27 neutralizing antibody after a hemorrhage, lowered lactoferrin gene activity.

 

Finally, the authors showed the iron binding protein lactoferrin may protect the brain from intracerebral hemorrhagic strokes. Mice and rats injected with lactoferrin 30 minutes after hemorrhages recovered faster and had reduced brain damage as compared to animals given placebo treatment. In one set of experiments, even giving mice lactoferrin 24 hours after a stroke was also effective.

 

Exposure to Pet and Pest Allergens During Infancy Linked to Reduced Asthma Risk

 

According to the Centers for Disease Control and Prevention, more than 8% of children in the United States currently have asthma, a chronic disease that intermittently inflames and narrows the airways. Asthma can result in missed time from school and work and is a major cause of emergency department visits and hospitalizations.

 

According to an article published on line in the Journal of Allergy and Clinical Immunology (19 September 2017), children exposed to high indoor levels of pet or pest allergens during infancy have a lower risk of developing asthma by 7 years of age. While previous studies have established that reducing allergen exposure in the home helps control established asthma, the new findings suggest that exposure to certain allergens early in life, before asthma develops, may have a preventive effect. The observations come from the ongoing Urban Environment and Childhood Asthma (URECA-pronounced “Eureka“) study, which is funded by NIAID through its Inner-City Asthma Consortium.

 

The ongoing URECA study investigates risk factors for asthma among children living in urban areas, where the disease is more prevalent and severe. Since 2005, URECA has enrolled 560 newborns from Baltimore, Boston, New York City and St. Louis at high risk for developing asthma because at least one parent has asthma or allergies. Study investigators have been following the children since birth, and the current research report evaluates the group through 7 years of age.

 

Results from 442 children for whom there was sufficient data to assess asthma status at age 7 years, showed that 130 children (29%) had asthma. Higher concentrations of cockroach, mouse and cat allergens present in dust samples collected from the children’s homes during the first three years of life (at age 3 months, 2 years and 3 years) were linked to a lower risk of asthma by age 7 years. The study observed a similar association for dog allergen, although it was not statistically significant. Additional analysis indicated that exposure to higher levels of these four allergens at age 3 months was associated with a lower risk of developing asthma.

 

Evidence also suggested that the microbial environment in the home during infancy may be associated with asthma risk. A previous report from URECA that assessed the microbiome of house dust collected in the first year of life, suggested that exposure to certain bacteria during infancy may protect 3-year-olds from recurrent wheezing, a risk factor for developing asthma. In the current report, the authors found associations between the abundance of certain types of bacteria in the house dust and an asthma diagnosis by age 7 years, suggesting that exposure to certain types of bacteria in early life might influence development of asthma. However, additional research is needed to clarify the potential roles of these microbial exposures in asthma development.

 

According to the authors, the results imply that exposure to a broad variety of indoor allergens, bacteria and bacterial products early in life may reduce the risk of developing asthma, but that additional research is needed to identify specific targets for asthma prevention strategies.

 

In addition, the seven-year URECA results confirm previous research linking development of childhood asthma to recognized risk factors such as prenatal exposure to tobacco smoke and maternal stress and depression. Investigators found that the presence of cotinine, which results from the breakdown of nicotine in the body, in the umbilical cord blood of newborns increased their risk of developing asthma by age 7 years. Maternal stress and depression reported during the first three years of the child’s life also were associated with an increased risk of developing childhood asthma. The URECA investigators are continuing to monitor the children. By dividing the children into groups based on characteristics of their allergies and asthma, the authors hope to uncover additional information about which early-life factors influence development of allergic or non-allergic asthma.

 

FDA Approves First Biosimilar for the Treatment of Cancer

 

Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

 

The FDA has approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

 

Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Specifically, the approved indications include:

 

1. Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.

 

2. Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.

 

3. Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.

 

4. Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.

 

5. Metastatic renal cell carcinoma, in combination with interferon alfa.

 

6. Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

 

The FDA’s approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product.

 

Common expected side effects of Mvasi include nose bleeds (epistaxis), headache, high blood pressure (hypertension), inflammation of the nasal cavity (rhinitis), high levels of protein in the urine (proteinuria), taste alteration, dry skin, rectal bleeding (hemorrhage), excessive tear production (lacrimation disorder), back pain and skin irritation (exfoliative dermatitis). Serious expected side effects of Mvasi include holes in or abnormal connection between two organs (perforation or fistula), blood clot formation (arterial and venous thromboembolic events), hypertension, problems in brain function or structure (posterior reversible encephalopathy syndrome), high levels of protein in the urine (proteinuria), infusion-related reactions and loss of function of the ovaries (ovarian failure). Patients should stop using Mvasi if these side effects become severe or life-threatening. Women who are pregnant should not take Mvasi because it may cause harm to a developing fetus.

 

Like Avastin, the labeling for Mvasi contains a Boxed Warning to alert health care professionals and patients about an increased risk of holes in the stomach and intestines (gastrointestinal perforations); surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding (hemorrhage). Patients should stop using Mvasi if gastrointestinal perforation occurs. Patients should not take Mvasi in the 28 days prior to and after elective surgery, and until the surgical wound is fully healed. Patients should stop using Mvasi if a surgical incision breaks open (wound dehiscence). Mvasi should not be given to patients with severe hemorrhage or in patients who cough up blood (hemoptysis).

 

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

 

The FDA granted approval of Mvasi to Amgen, Inc. Avastin was approved in February 2004 and is manufactured by Genentech, Inc.

 

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