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.

 

Good for Any Holiday: Carrots on the Side

Carrots-on-the-Side, a complete carrot change of pace, for your holiday table.  Enjoy!  ©Joyce Hays, Target Health Inc.

 

Ingredients

1 cup pistachios, shelled, then toasted

1 teaspoon cardamom

1 teaspoon baking soda

1 teaspoon baking powder

1/2 cup unsalted butter, + more to oil baking dish

1 and 1/4 cups almond flour

4 or 5 medium carrots, scrubbed, peeled, sliced

1/2 cup dark brown sugar

1 extra-large or large egg

Zest of 1 fresh lemon

1 teaspoon fresh lemon juice

1 Pinch salt

 

Easy to find ingredients.  ©Joyce Hays, Target Health Inc.

 

Directions

1. Preheat oven to 350 degrees.

2. With some of the extra butter, oil a pie baking dish, or any low baking dish.  I haven’t done it yet, but I think a loaf pan would also work well, although, it might be harder to remove a slice from a loaf pan.  It might crumble and not look as good on a plate; whereas it’s easy to cut a triangle shape, from a pie dish to plate.

 

With butter, oil the pie dish.  I added a little almond flour after oiling, but not necessary.  ©Joyce Hays, Target Health Inc.

 

3. Clean, peel, slice the carrots.  And toast your pistachios. (set aside)

 

Scrub, peel and slice the carrots.  ©Joyce Hays, Target Health Inc.

 

4. In a small deep pan, put the carrot slices, then pour water over them so they’re covered.

5. Bring carrots to a boil, over medium to high heat and cook until tender, 15 to 25 minutes.  If the water boils away, add more, so that the carrots are always covered, the whole cooking time.

6. When carrots are done, drain them in a colander, then pat dry with paper towel.

 

Draining the carrots.  ©Joyce Hays, Target Health Inc.

 

7. Now, put the carrot slices into a bowl of an electric mixer and mash them with a fork.  It’s more work, but you can put them in a food processor and pulse, until the carrots are smooth. Let carrots cool in the bowl or in the food processor.

 

Decided to use a food processor.  ©Joyce Hays, Target Health Inc.

 

8. When carrots have cooled down, (use a spatula to scrape out all the mashed carrots into the mixing bowl) add the baking soda and 1 Tablespoon warm water in the bowl of an electric mixer and mix to dissolve.

9. Next, into the mixing bowl, add the butter and dark brown sugar and beat.  Get this mixture nice and airy, then beat in the egg.

10. Keep the beaters going, while you add 1 pinch of salt, lemon zest and the fresh lemon juice.

 

Do your lemon zest first; put it into a small cup until ready to use.  ©Joyce Hays, Target Health Inc.

 

A citrus squeezer like this, strains pulp and catches the seeds.  ©Joyce Hays, Target Health Inc.

 

11. Next add the 1 teaspoon of cardamom, beat, then add the carrots and beat until the mixture is smooth.

12. Last, add the baking powder and the almond flour, and beat until the mixture is very smooth.

 

I used a regular mixing bowl along with a hand beater. This batter is now ready to pour & scrape into the pie dish. ©Joyce Hays, Target Health Inc.

 

13. With a spatula, pour, then scrape all of the batter, into your oiled pie dish.

 

Just poured the batter into the oiled pie dish and smoothed the top. ©Joyce Hays, Target Health Inc.

 

Going into the oven to bake for 20 minutes.  Then take out, sprinkle with pistachios and bake for another 10 minutes.  ©Joyce Hays, Target Health Inc.

 

14. Bake for 20 minutes, then remove and sprinkle chopped pistachios over the top.  Put make in oven and bake for another 10 to 20 minutes, depending on your oven.

15. Test your carrots by pushing with your fingers.  If it pops back easily, it’s done. Serve the carrot side dish warm along with any main course.  It will go well with lamb, fish, poultry, beef or a 100% vegetarian meal.

 

The first time I experimented with the carrots, I hadn’t yet thought to sprinkle with pistachios.  ©Joyce Hays, Target Health Inc.

 

Here’s a closeup of the lovely moist carrots on the side.  ©Joyce Hays, Target Health Inc.

 

Another attempt, this time with pistachios.  ©Joyce Hays, Target Health Inc.

 

Carrots-on-the-Side.  ©Joyce Hays, Target Health Inc.

 

We paired this chilled Pouilly-Fuisse with Carrots on the Side, along with a new recipe for veal meatballs in a mushroom sauce (still working on the sauce), mashed truffle cauliflower and my always changing recipe for saffron rice.  ©Joyce Hays, Target Health Inc.

 

We just saw, A Doll’s House Part 2, for which Laurie Metcalf won the 2017 Tony for best actress.  There were 7 other Tony nominations for this play.  However, sorry to say, neither Jules or I liked it.  Everyone (the talented people contributing to the production of this play are all awesome) involved in this play, gave it their all, but as far as we’re concerned, non of the creativity, saved it.  The interesting dialogue between Nora and her daughter, was not enough to carry the play.  We found the play boring, too talky and were flummoxed as to how there were so many Tony nominations, including a Tony nomination for best play.

We had dinner in one of our favorite mid-town restaurants, Sardis.  It’s the one tourist destination that continues to satisfy real New Yorkers, like us. We have the same corner banquette table held for us, each time we go. The staff is exceptionally friendly, food and wine are good, unique theater d?cor is the same for over 30 or more years, centrally located for theater goers; what’s not to like?

 

©Joyce Hays, Target Health Inc.

 

From Our Table to Yours

Bon Appetit!

 

Heart regeneration in salamanders depends on white blood cells

Date:
September 20, 2017

Source:
Mount Desert Island Biological Laboratory

Summary:
The answer to the question of why some organisms can regenerate major body parts while others, such as humans, cannot may lie with the body’s innate immune system, according to a new study of heart regeneration in the Mexican salamander.

 

The ability of the axolotl, or Mexican salamander, to regenerate the form and function of almost any body part makes it a popular model for the study of the genetic pathways for regeneration.
Credit: MDI Biological Laboratory

 

 

The answer to regenerative medicine’s most compelling question — why some organisms can regenerate major body parts such as hearts and limbs while others, such as humans, cannot — may lie with the body’s innate immune system, according to a new study of heart regeneration in the axolotl, or Mexican salamander, an organism that takes the prize as nature’s champion of regeneration.

The study, which was conducted by James Godwin, Ph.D., of the MDI Biological Laboratory in Bar Harbor, Maine, found that the formation of new heart muscle tissue in the adult axolotl after an artificially induced heart attack is dependent on the presence of macrophages, a type of white blood cell. When macrophages were depleted, the salamanders formed permanent scar tissue that blocked regeneration.

The study has significant implications for human health. Since salamanders and humans have evolved from a common ancestor, it’s possible that the ability to regenerate is also built into our genetic code.

Godwin’s research demonstrates that scar formation plays a critical role in blocking the program for regeneration. “The scar shoots down the program for regeneration,” he said. “No macrophages means no cardiac regeneration.”

Godwin’s goal is to activate regeneration in humans through the use of drug therapies derived from macrophages that would promote scar-free healing directly, or those that would trigger the genetic programs controlling the formation of macrophages, which in turn could promote scar-free healing. His team is already looking at molecular targets for drug therapies to influence these genetic programs.

“If humans could get over the fibrosis hurdle in the same way that salamanders do, the system that blocks regeneration in humans could potentially be broken,” Godwin explained. “We don’t know yet if it’s only scarring that prevents regeneration or if other factors are involved. But if we’re really lucky, we might find that the suppression of scarring is sufficient in and of itself to unlock our endogenous ability to regenerate.”

The prevailing view in regenerative biology has been that the major obstacle to heart regeneration in mammals is insufficient proliferation of cardiomyocytes, or heart muscle cells. But Godwin found that cardiomyocyte proliferation is not the only driver of effective heart regeneration. His findings suggest that research efforts should pay more attention to the genetic signals controlling scarring.

The extraordinary incidence of disability and death from heart disease, which is the world’s biggest killer, is directly attributable to scarring. When a human experiences a heart attack, scar tissue forms at the site of the injury. While the scar limits further tissue damage in the short term, over time its stiffness interferes with the heart’s ability to pump, leading to disability and ultimately to terminal heart failure.

In addition to regenerating heart tissue following a heart attack, the ability to unlock dormant capabilities for regeneration through the suppression of scarring also has potential applications for the regeneration of tissues and organs lost to traumatic injury, surgery and other diseases, Godwin said.

Godwin’s findings are a validation of the MDI Biological Laboratory’s unique research approach, which is focused on studying regeneration in a diverse range of animal models with the goal of gaining insight into how to trigger dormant genetic pathways for regeneration in humans. In the past year and a half, laboratory scientists have discovered three drug candidates with the potential to activate regeneration in humans.

“Our focus on the study of animals with amazing capabilities for regenerating lost and damaged body parts has made us a global leader in the field of regenerative medicine,” said Kevin Strange, Ph.D., MDI Biological Laboratory president. “James Godwin’s discovery of the role of macrophages in heart regeneration demonstrates the value of this approach: we won’t be able to develop rational and effective therapies to enhance regeneration in humans until we first understand regeneration works in animals like salamanders.”

Godwin, who is an immunologist, originally chose to look at the function of the immune system in regeneration because its role as the equivalent of a first responder at the site of an injury means that it is responsible for preparing the ground for tissue repairs. The recent study was a follow-up to an earlier study which found that macrophages also play a critical role in limb regeneration.

The next step is to study the function of macrophages in salamanders and compare them with their human and mouse counterparts. Ultimately, Godwin would like to understand why macrophages produced by adult mice and humans don’t suppress scarring in the same way as in axolotls and then identify molecules and pathways that could be exploited for human therapies.

Godwin holds a dual appointment with The Jackson Laboratory, also located in Bar Harbor, which is focused on the mouse as a model animal. The dual appointment allows him to conduct experiments that compare genetic programming in the highly regenerative animals used as models at the MDI Biological Laboratory with genetic programming in neonatal and adult mice.

Story Source:

Materials provided by Mount Desert Island Biological LaboratoryNote: Content may be edited for style and length.


Journal Reference:

  1. J. W. Godwin, R. Debuque, E. Salimova, N. A. Rosenthal. Heart regeneration in the salamander relies on macrophage-mediated control of fibroblast activation and the extracellular landscapenpj Regenerative Medicine, 2017; 2 (1) DOI: 10.1038/s41536-017-0027-y

 

Source: Mount Desert Island Biological Laboratory. “Immune system is critical to regeneration, study finds: Heart regeneration in salamanders depends on white blood cells.” ScienceDaily. ScienceDaily, 20 September 2017. <www.sciencedaily.com/releases/2017/09/170920154948.htm>.

Study challenges traditional presumptions of migratory behavior

Date:
September 20, 2017

Source:
University of Nebraska-Lincoln

Summary:
The onset of the last ice age may have forced some bird species to abandon their northerly migrations for thousands of years, says new research led by an ornithologist. The study challenges a long-held presumption that birds merely shortened their migratory flights when glaciers advanced south to cover much of North America and northern Europe about 21,000 years ago.

 

The University of Nebraska-Lincoln’s Robert Zink has authored a new study suggesting that the last ice age completely halted the northerly migrations of some bird species from about 21,000 to 12,000 years ago.
Credit: Craig Chandler, University of Nebraska-Lincoln

 

 

The onset of the last ice age may have forced some bird species to abandon their northerly migrations for thousands of years, says new research led by a University of Nebraska-Lincoln ornithologist.

Published Sept. 20 in the journal Science Advances, the study challenges a long-held presumption that birds merely shortened their migratory flights when glaciers advanced south to cover much of North America and northern Europe about 21,000 years ago.

The study concluded that the emergence of glaciers in those regions instead acted as an “adaptive switch” that turned off migratory behavior, transforming the tropics from a cold-weather resort into a long-term residence for certain bird species.

Of the 29 long-distance migrant species examined in the study, 20 likely saw their northern breeding grounds become uninhabitable, according to models developed by the researchers. When the climate again warmed and glaciers retreated back to the Arctic, those species presumably resumed their seasonal migrations.

Lead author Robert Zink said the conclusions could alter how scientists reconstruct the history of bird migration.

“It fundamentally changes the way we study the evolution of migration and think about the migratory behavior of birds,” said Zink, professor of natural resources and biological sciences at Nebraska.

Putting Migration On Ice

Researchers generally agree that, millions of years ago, many birds did not migrate from the tropics. But as the global climate began to warm, some species ventured beyond their native habitats to capitalize on better breeding and feeding opportunities afforded by the longer days and insect-rich environments of northern latitudes.

Those species eventually ventured farther and farther from their habitats, finally stopping when they reached environments that could not sustain them during the autumn and winter. They continued to migrate south when seasonal temperatures dropped and food sources waned.

In that context, Zink said his hypothesis suggests that the origin story of bird migration simply underwent multiple reboots, with the “migratory machinery” of birds halting for each of the 20 or so ice ages that have glazed Earth during the past 2.5 million years.

“Migrations are costly and risky,” said Zink, curator of zoology at the University of Nebraska State Museum. “They’re costly in terms of safety, energy — anything you can think of.”

Rather than paying those costs to reach breeding grounds that the encroaching glaciers had shrunk to tiny fractions of their former size, he said, birds instead resorted to their ancestral state: tropical homebodies.

“Some of them were forced so far south that it was no longer a fitness advantage to migrate, because the extra young they could produce south of the glacier wasn’t enough to compensate for the cost of migration,” Zink said, “and then coming back to the tropics and re-establishing their territory.

“To some people, that’s so completely off the wall that they may have trouble wrapping their heads around it — except that it’s the way they would explain to their classes the evolution of migration in the first place. So, in a sense, what I’m proposing is nothing novel. What’s novel about it is that (the advent of migration) probably occurred many times.”

Redrawing the Map

Zink and his co-author, the University of Minnesota’s Aubrey Gardner, conducted their study using a computer model that linked the modern-day distribution of bird species with climate variables — temperature, precipitation, seasonality — that characterize their habitats. By comparing those climates with conditions that existed during the last ice age, the model mapped the regions that likely could have supported each of those species from about 21,000 to 12,000 years ago.

In many cases, Zink said, the model either found no habitable regions beyond the tropics or located habitats so miniscule that they would have struggled to support sizable populations of the species.

“Some species were probably just forced (slightly) south of the glaciers, and their habitats were extensive enough that they would maybe maintain some migratory ability,” he said. “But for others, I think there was so little predicted habitat that they just ceased migration all together.

“This evolution of migration is a very (variable) thing. Normally, when we think of evolution, we think of singular, unique events in evolutionary history. But in this case, the ability to migrate is entrenched in birds. They have the ability to navigate using the sun, the stars, the (Earth’s) magnetic field. They have the ability to put on large amounts of fat and sustain trans-gulf migrations. Birds are (adaptive) enough in their behavior and physiology that this wasn’t a reinvention of some incredible phenomenon.”

And if some species did transition back and forth from sedentary to migratory states, researchers should consider pruning certain evolutionary trees accordingly, Zink said. Many evolutionary trees currently treat migration as an irreversible trait rather than a variable behavior, he said, and that assumption could be misinforming discussions of when and where it evolved.

“I wanted to point out that this was a real danger and fallacy that’s being committed: mapping something onto an evolutionary tree where the feature — migration or sedentariness — changes faster than new species evolved,” he said. “You would have constructed the history of migration totally differently.”

Story Source:

Materials provided by University of Nebraska-Lincoln. Original written by Scott Schrage. Note: Content may be edited for style and length.


Journal Reference:

  1. Robert M. Zink, Aubrey S. Gardner. Glaciation as a migratory switchScience Advances, 2017; DOI: 10.1126/sciadv.1603133

 

Source: University of Nebraska-Lincoln. “Fly away home? Ice age may have clipped bird migration: Study challenges traditional presumptions of migratory behavior.” ScienceDaily. ScienceDaily, 20 September 2017. <www.sciencedaily.com/releases/2017/09/170920144653.htm>.

Date:
September 19, 2017

Source:
NASA/Goddard Space Flight Center

Summary:
Arctic sea ice appeared to have reached its yearly lowest extent on Sept. 13, scientists have reported. Analysis of satellite data showed that at 1.79 million square miles (4.64 million square kilometers), this year’s Arctic sea ice minimum extent is the eighth lowest in the consistent long-term satellite record, which began in 1978.

 

 

Arctic sea ice appeared to have reached its yearly lowest extent on Sept. 13, NASA and the NASA-supported National Snow and Ice Data Center (NSIDC) at the University of Colorado Boulder have reported. Analysis of satellite data by NSIDC and NASA showed that at 1.79 million square miles (4.64 million square kilometers), this year’s Arctic sea ice minimum extent is the eighth lowest in the consistent long-term satellite record, which began in 1978.

 

Arctic sea ice, the layer of frozen seawater covering much of the Arctic Ocean and neighboring seas, is often referred to as the planet’s air conditioner: its white surface bounces solar energy back to space, cooling the globe. The sea ice cap changes with the season, growing in the autumn and winter and shrinking in the spring and summer. Its minimum summertime extent, which typically occurs in September, has been decreasing, overall, at a rapid pace since the late 1970s due to warming temperatures.

This year, temperatures in the Arctic have been relatively mild for such high latitudes, even cooler than average in some regions. Still, the 2017 minimum sea ice extent is 610,000 square miles (1.58 million square kilometers) below the 1981-2010 average minimum extent.

“How much ice is left at the end of summer in any given year depends on both the state of the ice cover earlier in the year and the weather conditions affecting the ice,” said Claire Parkinson, senior climate scientist at NASA’s Goddard Space Flight Center in Greenbelt, Maryland. “The weather conditions have not been particularly noteworthy this summer. The fact that we still ended up with low sea ice extents is because the baseline ice conditions today are worse than the baseline 38 years ago.”

The three years with the lowest Arctic ice extents on record — 2012, 2016 and 2007 — experienced strong summer storms that hammered the ice cover and sped up its melt. “In all of those cases, the weather conditions contributed to the reduced ice coverage. But if the exact same weather system had occurred three decades ago, it is very unlikely that it would have caused as much damage to the sea ice cover, because back then the ice was thicker and it more completely covered the region, hence making it more able to withstand storms,” Parkinson said.

On the other side of the planet, Antarctica is heading to its maximum yearly sea ice extent, which typically occurs in September or early October. This year’s maximum extent is likely to be among the eight lowest in the satellite record — a dramatic turn of events considering that 2012, 2013 and 2014 all saw consecutive record high maximum extents, followed by a sudden large drop in 2015 and a further although smaller decrease in 2016. So far, the September Antarctic ice extents this year are comparable to those of a year ago.

“What had been most surprising about the changing sea ice coverage in the past three decades was the fact that the Antarctic sea ice was increasing instead of decreasing,” Parkinson said. “The fact of Arctic sea ice decreases was not as shocking because this was expected with a warming climate, although the overall rate of the decreases was greater than most models had forecast.”

Parkinson said that although it is still too early to talk about a long-term reversal in the behavior of Antarctic sea ice, the decreases witnessed in the past two years provide important data to test the various hypotheses that scientists have put forward to explain why Antarctic sea ice coverage had been increasing, overall, between 1979 and 2015.

Adding the Antarctic and Arctic sea ice extents month by month through the satellite record shows that globally the Earth has been losing sea ice since the late 1970s in each portion of the annual cycle of ice growth and decay. “In fact, this year, every single month from January through August experienced a new monthly record low in global sea ice extents,” Parkinson said.

Story Source:

Materials provided by NASA/Goddard Space Flight CenterNote: Content may be edited for style and length.

 

Source: NASA/Goddard Space Flight Center. “End-of-summer Arctic sea ice extent is eighth lowest on record.” ScienceDaily. ScienceDaily, 19 September 2017. <www.sciencedaily.com/releases/2017/09/170919160152.htm>.

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