The Clinical Trials Transformation Initiative (CTTI) and Managing Change

 

Target Health has been a member of the Steering Committee of the Clinical Trials Transformation Initiative since 2008 and it has been a superior journey. At the Steering Committee meeting this past week in Washington, the theme focused on implementing and managing change within organizations. Companies large and small, as well as FDA shared what they are doing to bring all aspects of clinical research into the 21st century in order to get novel and innovative drugs and devices to patients in a timely and cost-effective manner. There were candid and forthright discussions and one of the conclusions was that in order to make things happen, find people who want to do it, support them, let them experiment, and yes fail from time to time, and do not be afraid of change.

 

Springtime in New York City is Glorious

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Springtime in NYC – Park Avenue Mall ©Target Health Inc. 2016

 

ON TARGET is the newsletter of Target Health Inc., a NYC – based, full – service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

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 or Ms. Joyce Hays. 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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Public Health: Soil Conservation Leads to Healthy Crops, Leading to Healthy Consumption and Healthy Humans

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Soil Profile: Soil scientists use the capital letters O, A, B, C, and E to identify the master horizons, and lowercase letters for distinctions of these horizons. Most soils have three major horizons?the surface horizon (A), the subsoil (B), and the substratum (C). Some soils have an organic horizon (O) on the surface, but this horizon can also be buried. The master horizon, E, is used for subsurface horizons that have a significant loss of minerals (eluviation). Hard bedrock, which is not soil, uses the letter R. Graphic credit: Wilsonbiggs – derived work from File:SOIL PROFILE.png by Hridith Sudev Nambiar at English Wikipedia., CC BY-SA 4.0,https://commons.wikimedia.org/w/index.php?curid=46207693

 

“A nation that destroys its soil destroys itself.“ – Franklin D. Roosevelt

 

The Romans realized that the soil would become depleted if it did not receive fertilization. They were one of the early civilizations to employ a type of mixed farming. They would use manure from their farm animals to help revitalize their 1) ___. Yet the Romans did suffer from a decline in food production toward the end of their empire due to land overuse. One factor contributing to the fall of past civilizations, like Mesopotamia, and those of the Mediterranean region, was due in part to bad management of the landscape.

 

The U.S. is beginning to measure soil health by specific benchmarks used to evaluate soil health like CO2 release, humus levels, microbial activity, and available calcium. Soil health testing is spreading in the USA, Australia and Europe. Cornell University has had a Soil Health Test since 2006 and offers many types of individual soil health tests as well as three different soil health testing packages. The approach is to add into common chemical nutrient testing a biological set of factors not normally included in routine soil 2) ___ . The best example is adding biological soil respiration (CO2-Burst) as a test procedure; this has already been adapted to modern commercial labs in the past 10 years. In the last 40 years, USA soils have also lost up to 75% of their carbon (humus), causing biological fertility to drop drastically. Many critics of the current system say this is sufficient evidence that the old soil testing models have failed us, and need to be replaced with new approaches. These older models have stressed “maximum 3) ___“ and “ yield calibration“ to such an extent that related factors have been overlooked. As a result, huge agri-business farming has overlooked enormous quantities of valuable top soil erosion, replaced with synthetic fertilizer. Also used to replace lost soil nutrients, these farms have caused surface and groundwater pollution, by adding excessive amounts of nutrients like nitrates and phosphates, which eventually end up in our waterways and our 4) ___ water. This problem has grown enormously, and is reported to be the worst in the U.S. since the 1970s, before the advent of environmental consciousness.

 

In a healthy farm system, agriculture works in harmony with the natural environment. This begins with healthy soil that stores water and nutrients and provides a stable base to support plant roots. In a sustainable system, soil is kept in balance. Crops are rotated through the fields to replace 5) ___ in the soil. Where there is livestock, animals graze the land, then waste from those animals is used to fertilize the soil. The idea is that as farmers take from the land they also give back. Industrial farms disregard that need for balance. Land is used continuously and not given proper rest. Crops are not rotated in a way that replenishes the soil. Manure and chemical fertilizers are used to “feed“ the soil, but through over-application these additives become a problem. Factory farms concentrate an unnatural number of animals in one place, which creates an unmanageable amount of waste. For example, a single hog excretes up to 17.5 pounds of manure and urine each day. Put 1,000 hogs together, and that’s six million pounds of waste each year. On a factory farm containing 35,000 hogs,  over four million pounds of waste are produced each week, and over 200 million pounds each year. Large concentrations of animals squeezed together, causes 6) ___ which is why so many animals are given antibiotics, usually in their feed. On a sustainable farm, animal waste can be a tool, in factory-farm amounts it becomes a major pollutant.

 

The creation and disposal of such enormous quantities of waste has a devastating effect on the air, water and soil surrounding factory farms. Unlike human waste, livestock manure is not processed for sanitation. On factory farms it is commonly mixed with water and held in pits (called “lagoons“), and then spread or sprayed on cropland. But the system often suffers from an excess of manure: the lagoons can leak or spill, for instance, or the manure is over-applied to fields, which can cause it to run off into surface waters. This manure carries with it other substances that are used on industrial farms. These include 7) ___ and artificial growth hormones, which contaminate waterways and affect the plants and animals that live in them. Salt, a common component of manure from industrial dairies, can damage soil quality and contributes to erosion. All of these nutrients and heavy metals present in animal feed are also excreted by livestock, and so end up being applied to cropland. These include zinc, copper, chromium, arsenic, cadmium and even lead. In balanced amounts, some of these elements can be good for soil and promote plant growth. But as factory farms over-apply manure to fields, a significant quantity of nutrients builds up in the soil and can actually reduce the soil’s fertility. This damage is difficult to reverse, and ultimately puts fertile cropland out of use. Factory farms emit harmful gases and particles such as methane and hydrogen sulfide, which can contribute to global warming and harm the health of those living or working nearby. Air pollution results from the overuse of machinery, the mismanagement of manure, and the irresponsible feeding practices that characterize industrial farming. Chemical fertilizers and pesticides have turned agriculture into a leading source of water pollution in the United States. Runoff from factory farms kills fish, degrades aquatic habitats and threatens drinking water supplies. Additionally, factory farms use tremendous amounts of water, which cuts into our precious supplies of water that are not contaminated.

 

Soil is not just dirt! Soil is a mixture of minerals, air, water, and organic matter such as roots, decaying plant parts, fungi, earthworms, bacteria, and microorganisms. An acre of healthy topsoil can contain 900 pounds of earthworms, 2,400 pounds of fungi, 1,500 pounds of bacteria, 133 pounds of protozoa, and 890 pounds of arthropods and algae. Factory farms also harm American farmland through their consumption of massive quantities of feed crops. Consider this: The average cow eats roughly 30 pounds of food each day. The beef industry raises more than 30 million cows each year. Some of those cows feed themselves by grazing on pasture, but the vast majority are raised in feedlots, where they eat corn and soybeans. The result: American cropland is pushed hard to produce an extraordinary amount of grain. And the natural grazing food for cows is not corn, which makes them sick. In response to this demand, conventional crop producers have adopted intensive growing practices. These methods increase crop yields, but they also damage the soil and throw natural systems out of balance, primarily due to erosion and loss of fertility. Crop farming is an “extractive“ process, meaning that as plants grow, they take nutrients from the soil and turn it into plant matter. When the plants are harvested, the nutrients leave the soil’s system. Sustainable practices replenish these nutrients, using compost, manure, or “green manures,“ which are plants that naturally deposit nutrients in the soil. Instead of replenishing the soil, intensive practices use chemical fertilizers to supply only what is necessary to grow the next round of crops. Chemical fertilizers are not as effective as natural sources of fertility, and are known to cause long-term depletion of organic matter, soil compaction, and degradation of overall soil quality. In 2005, American farmers used more than 22 million tons of chemical fertilizers.

 

Tilling is another aspect of farming that has gone out of balance in industrial practice. When land is plowed, old organic matter is turned under the soil in order to plant a new crop. However, when soil is bare it is most susceptible to 8) ___. There are many ways to protect against this. Farmers can leave strips of land untilled, to act as a catch for water-borne erosion. Instead of plowing up and down hills, leaving furrows that carry wet soil straight downhill, they can plow with the contours, making furrows that act as tiny retaining walls. And they can grow cover crops in the off-season, whose plants anchor the soil with their 9) ___. In the drive to produce ever more grain, however, precautions like these are often not taken. Currently, the average rate of soil erosion on US cropland is seven tons per acre per year. This is a serious problem, because erosion causes fertile farmland to lose nutrients and water retention ability. Because the first thing to go is precious topsoil, the soil removed by erosion contains about three times more nutrients and 1.5 to five times more organic matter than that which remains behind. The National Sustainable Agriculture Information Service writes that erosion is the single greatest threat to soil productivity in the United States.

 

Organic fertilizers are composed entirely of organic matter such as manure and compost, these contain a wide range of nutrients and replenish the soil’s organic composition. USDA “Certified Organic“ produce can only be grown using natural fertilizers. A nutrient-rich mixture of decaying organic matter (typically leaves and other plant parts) used as fertilizer for plants. Synthetic or chemical fertilizer is composed primarily of nitrogen, phosphorus, and potassium; these petroleum-based soil additives lack the organic matter contained in natural fertilizers.

 

By using farming techniques such as crop 10) ___, conservation tillage, raising animals on pasture and natural fertilization, sustainable farmers produce food without having a negative effect on the environment. Instead of harming soil, air and water, sustainable farms actually enhance and preserve the land so that future generations can continue to use it for healthy food production.

 

ANSWERS: 1) soils; 2) testing; 3) yield; 4) drinking; 5) nutrients; 6) sickness; 7) antibiotics; 8) erosion; 9) roots; 10) rotation

 

William Prout MD (1785-1850) and Michael Pollan (1955 to Present)

 

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William Prout by Henry Wyndham Phillips; Source: Wikipedia commons

 

William Prout FRS (1785-1850) was an English chemist, physician, and natural theologian. He is remembered today mainly for what is called Prout’s hypothesis. Our History of Medicine series is interested in Prout because he was one of the first (if not the first) to do chemical research into food substances and their relationship to human health.

 

Prout was born in Horton, Gloucestershire in 1785 and educated at 17 years of age by a clergyman, followed by the Redland Academy at Bristol and Edinburgh University, where he graduated with an MD degree in 1811. His professional life was spent as a practicing physician in London, but he also occupied himself with chemical research. He was an active worker in biological chemistry and carried out many analyses of the secretions of living organisms, which he believed were produced by the breakdown of bodily tissues. In 1823, he discovered that stomach juices contain hydrochloric acid, which can be separated from gastric juice by distillation. In 1827, he proposed the classification of substances in food into sugars and starches, oily bodies, and albumen, which would later become known as carbohydrates, fats, and proteins. Prout is better remembered, however, for his researches into physical chemistry. In 1815, based on the tables of atomic weights available at the time, he anonymously hypothesized that the atomic weight of every element is an integer multiple of that of hydrogen, suggesting that the hydrogen atom is the only truly fundamental particle (which he called protyle), and that the atoms of the other elements are made of groupings of various numbers of hydrogen atoms. While Prout’s hypothesis was not borne out by later more-accurate measurements of atomic weights, it was a sufficiently fundamental insight into the structure of the atom that in 1920, Ernest Rutherford chose the name of the newly discovered proton to, among other reasons, give credit to Prout. He also contributed to the improvement of the barometer, and the Royal Society of London adopted his design as a national standard.

 

Prout was elected a Fellow of the Royal Society in 1819 and delivered the Goulstonian Lecture to the Royal College of Physicians in 1831 on the application of chemistry to medicine. He wrote the eighth Bridgewater Treatise, Chemistry, Meteorology, and the Function of Digestion, considered with reference to Natural Theology. It was in this work that he coined the term “convection“ to describe a type of energy transfer. The Prout is a unit of nuclear binding energy, and is 1/12 the binding energy of the deuteron, or 185.5 keV. It is named after William Prout.

 

In 1814, Prout married Agnes Adam, daughter of Alexander Adam, of Edinburgh, Scotland, and together they had six children. Prout died in London in 1850 and was buried in Kensal Green Cemetery.

 

Michael Pollan (1955 to Present)

 

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Michael_Pollan speaking_at_Yale in 2011. Source: Ragesossderivative work: Gobonobo (talk) – Michael_Pollan_at_Yale_1.jpg, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=14734781

 

Michael Pollan is an American author, journalist, activist, and professor of journalism at the UC Berkeley Graduate School of Journalism. He was born on Long Island, New York and is the son of author and financial consultant Stephen Pollan and columnist Corky Pollan. Pollan received a B.A. in English from Bennington College in 1977 and an M.A. in English from Columbia University in 1981.

 

In The Omnivore’s Dilemma, Pollan describes four basic ways that human societies have obtained food: the current industrial system, the big organic operation, the local self-sufficient farm, and the hunter-gatherer. Pollan follows each of these processes – from a group of plants photosynthesizing calories through a series of intermediate stages, ultimately into a meal. Along the way, he suggests that there is a fundamental tension between the logic of nature and the logic of human industry. That the way we eat represents our most profound engagement with the natural world, and that industrial eating obscures crucially important ecological relationships and connections. On December 10, 2006 The New York Times named The Omnivore’s Dilemma one of the five best nonfiction books of the year. On May 8, 2007, the James Beard Foundation named The Omnivore’s Dilemma its 2007 winner for the best food writing. It was the book of focus for the University of Pennsylvania’s Reading Project in 2007, and the book of choice for Washington State University’s Common Reading Program in 2009-10.

 

Pollan’s discussion of the industrial food chain is in large part a critique of modern agribusiness. According to the book, agribusiness has lost touch with the natural cycles of farming, wherein livestock and crops intertwine in mutually beneficial circles. Pollan’s critique of modern agribusiness focuses on what he describes as the overuse of corn for purposes ranging from fattening cattle to massive production of corn oil, high-fructose corn syrup, and other corn derivatives. He describes what he sees as the inefficiencies and other drawbacks of factory farming and gives his assessment of organic food production and what it’s like to hunt and gather food. He blames those who set the rules (e.g., politicians in Washington, D.C., bureaucrats at the United States Department of Agriculture, Wall Street capitalists, and agricultural conglomerates like Archer Daniels Midland) of what he calls a destructive and precarious agricultural system that has wrought havoc upon the diet, nutrition, and well-being of Americans. Pollan finds hope in Joel Salatin’s Polyface Farm in Virginia, which he sees as a model of sustainability in commercial farming. Pollan appears in the documentary film King Corn (2007). In The Botany of Desire, Pollan explores the concept of co-evolution, specifically of humankind’s evolutionary relationship with four plants – apples, tulips, marijuana, and potatoes – from the dual perspectives of humans and the plants. He uses case examples that fit the archetype of four basic human desires, demonstrating how each of these botanical species are selectively grown, bred, and genetically engineered. The apple reflects the desire for sweetness, the tulip beauty, the marijuana intoxication, and the potato control. Pollan then unravels the narrative of his own experience with each of the plants, which he intertwines with a well-researched exploration into their social history. Each section presents a unique element of human domestication, or the “human bumblebee“ as Pollan calls it. These range from the true story of Johnny Appleseed to Pollan’s first-hand research with sophisticated marijuana hybrids in Amsterdam, to the alarming and paradigm-shifting possibilities of genetically engineered potatoes.

 

Pollan’s book In Defense of Food: An Eater’s Manifesto, released on January 1, 2008, explores the relationship with what he terms nutritionism and the Western diet, with a focus on late 20th century food advice given by the science community. Pollan holds that consumption of fat and dietary cholesterol does not lead to a higher rate of coronary disease, and that the reductive analysis of food into nutrient components is a mistake. He questions the view that the point of eating is to promote health, pointing out that this attitude is not universal and that cultures that perceive food as having purposes of pleasure, identity, and sociality may end up with better health. He explains this seeming paradox by vetting, and then validating, the notion that nutritionism and, therefore, the whole Western framework through which we intellectualize the value of food is more a religious and faddish devotion to the mythology of simple solutions than a convincing and reliable conclusion of incontrovertible scientific research. Pollan spends the rest of his book explicating his first three phrases: “Eat food. Not too much. Mostly plants.“ He contends that most of what Americans now buy in supermarkets, fast food stores, and restaurants is not in fact food, and that a practical tip is to eat only those things that people of his grandmother’s generation would have recognized as food.

 

In 2009, Food Rules: An Eater’s Manual was published. This short work is a condensed version of his previous efforts, intended to provide a simple framework for healthy and sustainable diet. It is divided into three sections, further explicating Pollan’s principles of “Eat food. Not too much. Mostly plants.“ It includes his rules (i.e., “let others sample your food“ and “the whiter the bread, the sooner you’ll be dead“). In Cooked: A Natural History of Transformation, published in 2013, Pollan explores the methods by which cooks mediate “between nature and culture.“ The book is organized in four sections corresponding to the classical elements of Fire (cooking with heat), Water (braising and boiling with pots), Air (breadmaking), and Earth (fermenting). Pollan has contributed to Greater Good, a social psychology magazine published by the Greater Good Science Center at University of California, Berkeley. His article “Edible Ethics“ discusses the intersection of ethical eating and social psychology. In his 1998 book A Place of My Own: The Education of an Amateur Builder, Pollan methodically traced the design and construction of the out-building where he writes. The 2008 re-release of this book was re-titled A Place of My Own: The Architecture of Daydreams. In 2014 Pollan wrote the foreword in the healthy eating cookbook The Pollan Family Table. The book is co-authored by his mother Corky Pollan and sisters Lori Pollan, Dana Pollan, and Tracy Pollan.

 

Pollan is a contributing writer for the New York Times Magazine, a former executive editor for Harper’s Magazine, and author of five books: In Defense of Food: An Eater’s Manifesto (2008) The Omnivore’s Dilemma: A Natural History of Four Meals (2006), The Botany of Desire: A Plant’s-Eye View of the World (2001), A Place of My Own (1997), and Second Nature: A Gardener’s Education (1991). In 2016, Netflix will release a four-part documentary series based on Pollan’s book Cooked (2013) and directed by Alex Gibney. In 2015, a documentary version of Pollan’s book In Defense of Food premiered on PBS. Pollan also co-starred in the documentary, Food, Inc. (2008), for which he was also a consultant. In 2010 Pollan was interviewed for the film Queen of the Sun: What are the bees telling us?, a feature-length documentary about honey bees and colony collapse disorder. He was also interviewed for Vanishing of the Bees, a documentary also about colony collapse, directed by Maryam Henein and George Langworthy.

 

In 2015, Pollan received the Washburn Award from the Boston Museum of Science, awarded annually to “an individual who has made an outstanding contribution toward public understanding and appreciation of science and the vital role it plays in our lives“ and was named as a fellow at Harvard University’s Radcliffe Institute for Advanced Study. He has also won the James Beard Leadership award, the Reuters World Conservation Union Global Awards in environmental journalism, the James Beard Foundation Awards for best magazine series in 2003, and the Genesis Award from the Humane Society of the United States. His articles have been anthologized in Best American Science Writing (2004), Best American Essays (1990 and 2003), The Animals: Practicing Complexity (2006) and the Norton Book of Nature Writing (1990).

 

Greenness Around Homes Linked to Lower Mortality

 

According to an article published online in the journal Environmental Health Perspectives (14 April 2016), women with the highest levels of vegetation, or greenness, near their homes had a 12% lower death rate compared to women with the lowest levels of vegetation near their homes. The study found the biggest differences in death rates from kidney disease, respiratory disease, and cancer. The study also explored how an environment with trees, shrubs, and plants might lower mortality rates and results showed that improved mental health and social engagement are the strongest factors, while increased physical activity and reduced air pollution also contribute.

 

The study examined greenness around the homes of 108,630 women in the long-term Nurses’ Health Study by mapping home locations and using high resolution satellite imagery to determine the level of vegetation within 250 meters and 1,250 meters of homes. The study then followed the women from 2000 to 2008, tracking changes in vegetation and participant deaths. During the study, 8,604 deaths occurred.

 

The results consistently found lower mortality rates in women as levels of trees and plants increased around their homes. This trend was seen for separate causes of death, as well as when all causes were combined. When study compared women in the areas with highest greenness to women in the lowest, they found a 41% lower death rate for kidney disease, 34% lower death rate for respiratory disease, and 13% lower death rate for cancer in the greenest areas.

 

The authors also looked at characteristics that can otherwise contribute to mortality risk, such as age, race, ethnicity, smoking, and socioeconomic status. This enabled them to be more confident that vegetation plays a role in reduced mortality, rather than these factors. The authors even took into consideration if participants moved or the vegetation near their homes changed during the study.

 

Body-Mass Index in 2.3 Million Adolescents and Cardiovascular Death in Adulthood

 

In light of the worldwide increase in childhood obesity, a study published online the New England Journal of Medicine (13 April 2016), examined the association between body-mass index (BMI) in late adolescence and death from cardiovascular causes in adulthood.

Data on BMI, as measured from 1967 through 2010 in 2.3 million Israeli adolescents (mean age, 17.3 years), were grouped according to age- and gender-specific percentiles from the U.S. Centers for Disease Control and Prevention. Primary outcomes were the number of deaths attributed to coronary heart disease, stroke, sudden death from an unknown cause, or a combination of all three categories (total cardiovascular causes) by mid-2011.

Results showed that during 42,297,007 person-years of follow-up, 2,918 of 32,127 deaths (9.1%) were from cardiovascular causes, including 1,497 from coronary heart disease, 528 from stroke, and 893 from sudden death. On multivariable analysis, there was a graded increase in the risk of death from cardiovascular causes and all causes that started among participants in the group that was in the 50th to 74th percentiles of BMI (i.e., within the accepted normal range). After adjustment for gender, age, birth year, sociodemographic characteristics, and height, the hazard ratios in the obese group (>95th percentile for BMI), as compared with the reference group in the 5th to 24th percentiles, were 4.9 for death from coronary heart disease, 2.6 for death from stroke, 2.1 for sudden death, and 3.5 for death from total cardiovascular causes, all statistically significant. Hazard ratios for death from cardiovascular causes in the same percentile groups increased from 2.0 during follow-up for 0 to 10 years to 4.1 during follow-up for 30 to 40 years; during both periods, hazard ratios were consistently high for death from coronary heart disease. The findings also persisted in extensive sensitivity analyses.

The authors concluded that a BMI in the 50th to 74th percentiles, within the accepted normal range, during adolescence was associated with increased cardiovascular and all-cause mortality during 40 years of follow-up and that overweight and obesity were strongly associated with increased cardiovascular mortality in adulthood.

 

Marzipan Matzo Minis

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Unheard of, right?, that such an unbelievably delicious dessert is so-o-easy to make. That’s one of my goals in sharing recipes with friends, colleagues, clients around the world. Easy, yummy and mostly healthy. These marzipan matzo minis don’t even have to be baked. ©Joyce Hays, Target Health Inc.

 

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Chocolate Matzo-Marzipan Heaven! ©Joyce Hays, Target Health Inc.

 

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Sharing a fresh batch with Jules, a few days ago. We always taste test everything, several times, before sharing it in our newsletter. ©Joyce Hays, Target Health Inc.

 

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One of the most delectable desserts I have ever made! ©Joyce Hays, Target Health Inc.

 

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Easily Obtainable Ingredients. ©Joyce Hays, Target Health Inc.

 

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One of the ingredients for the Marzipan Matzo Minis is leftover Jerusalem Cake (or any simple pound cake). Here is the leftover Jerusalem cake we made a few days earlier. ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

1 cup of left-over Jerusalem cake crumbs or PLAIN pound cake or biscotti, or left over coffee cake

1 cup of matzo crumbled up by hand

3.5 Tablespoons of soft non-dairy margarine

2 heaping Tablespoons of cacao powder (highest percent pure cacao)

5 Tablespoons rum or your favorite liqueur, like amaretto

2 cans Marzipan (11 ounces), (make it yourself, or buy it from Whole Foods or from Nuts.com)

Blue food coloring

White (you get white when you add zero food coloring)

1 whole bar of semi-sweet chocolate

 

Directions

 

In a medium mixing bowl, start by mixing margarine, cake crumbs, matzo crumbs and rum together.

Mix the cacao powder into the bowl.

Next, mix all the ingredients in the bowl, until they’re combined well.

 

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The filling will look like this. The matzo crumbs stand out, at first as the biggest, but by the time you eat this delicious dessert, everything will be well mixed together. ©Joyce Hays, Target Health Inc.

 

 

Roll the filling out, with a rolling pin, on a sheet of wax paper, (and put a 2nd piece of paper or saran wrap over the filling, before you roll it out) like one big chocolate pancake. Make this a thin pancake. Put another sheet of wax paper on top of the filling dough and put into the freezer for 1 hour.

While the filling dough is in the freezer, prepare the marzipan.

Divide the marzipan (2 cans, 11 oz. each), into 2 separate bowls. Into one bowl add 3 drops of the blue food coloring. Leave the second bowl, plain, as is, so you get a white color.

Use your hands, and work the blue coloring into the marzipan dough, so it becomes a beautiful soft color. Wash your hands after you finish squeezing the blue food coloring into ? of the marzipan.

 

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Work the food coloring into the marzipan, as if you were playing with a stress ball. The white marzipan is the way it comes out of the can. If you wanted all the marzipan matzo to be blue, then add 3 or more drops of blue food coloring to the second portion, which I left to be white. ©Joyce Hays, Target Health Inc.

 

 

After the filling has been in the fridge for at least 1 hour, or more, take it out.

Prepare the white and blue marzipan.

Roll out the blue marzipan, so it’s thin, but not so-o thin that it breaks apart and cannot hold the filling. Roll the marzipan between two pieces of saran wrap or waxed paper, so you don’t get annoying little pieces, sticking to the rolling pin.

 

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The blue marzipan is being rolled out between two sheets of waxed paper or saran wrap. ©Joyce Hays, Target Health Inc.

 

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White marzipan, between two pieces of saran wrap, is being rolled out. ©Joyce Hays, Target Health Inc.

 

 

When you take the chocolate/rum filling out of the fridge, divide it into two parts. After you roll out the two different parts of the marzipan, remove the top layer of saran wrap from the marzipan.

Put one half of the filling on the rolled out blue marzipan and the other half of filling on the rolled out white marzipan and slowly, roll the marzipan around the chocolate filling, until you have a completed tube of marzipan rolled around the chocolate.

 

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Starting to roll the marzipan around the filling. ©Joyce Hays, Target Health Inc.

 

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Marzipan tube is done; now ready to trim the ends off. Of course, you will eat the trimmed ends or arrange them attractively on a plate for others to pick at. ©Joyce Hays, Target Health Inc.

 

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If you get a little break in the marzipan (see above) as you roll it around the filling, just pinch it together or take a tiny piece of marzipan from the end, and patch it over the break, pinching and molding it together, like clay or playdough. This is a very forgiving recipe; there’s nothing here that can’t be fixed, as you go along. You could also, try first, not to roll the marzipan out, too thin. ©Joyce Hays, Target Health Inc.

 

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After you trim unruly ends off of the marzipan tube, you will divide the tube into 4 to 6 separate mini cakes. ©Joyce Hays, Target Health Inc.

 

After you make a tube of blue marzipan and a tube of white, cut each tube into mini cakes about an inch and 1/2 long.

Put these minis in the freezer again, for 1 hour.

While the rolls are in the freezer, in a small double boiler, or tiny pan, melt the chocolate carefully. Melt the chocolate over a very low flame. If you have a simmer setting on your stove, put the chocolate on simmer.

 

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Melting the semi-sweet baking chocolate. Mmmmm, smells so-o good. ©Joyce Hays, Target Health Inc.

 

 

After an hour, take out the rolls, from the freezer, and dip each of the ends of the 1.5 inch rolls, into the melted chocolate. Put on foil or paper towel to cool down and harden.

 

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Into the melted chocolate, dip one end of the mini cake, then the other end. Do this step very slowly, or else you could get chocolate dripping all over the place. Even after experimenting with this recipe at least 10 times this year, there’s a chocolate finger print (above) that couldn’t be helped. It won’t show up as much on the blue minis, but just be aware of this. ©Joyce Hays, Target Health Inc.

 

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Dipping the other end into the melted chocolate. ©Joyce Hays, Target Health Inc.

 

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Dipping a blue marzipan-matzo in the melted chocolate. ©Joyce Hays, Target Health Inc.

 

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Dipping the other side of the blue marzipan-matzo. ©Joyce Hays, Target Health Inc.

 

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Cooling down and hardening, on a piece of foil. ©Joyce Hays, Target Health Inc.

 

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Note: Make the Jerusalem cake way before the marzipan-matzos. On its own, it’s a delicious dessert (serve it soaked in rum, with apricot jam on top, then add cool whip) and warmed up in the morning, it’s wonderful with a nice hot cup of freshly ground coffee. Later, use it crumbled, as one of the ingredients in the filling of the marzipan-matzos. ©Joyce Hays, Target Health Inc.

 

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Let the marzipan matzos cool on a counter, so the chocolate hardens.

 

When the chocolate has hardened, put on a plate, dessert serving platter or small tray.

 

Serve and enjoy!

 

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One of our favorite whites is Stag’s Leap Wine Cellars, (Napa Valley) Sauvignon Blanc, Aveta, served chilled.  ©Joyce Hays, Target Health Inc.

 

Spring in Manhattan is beauty stretched out in ribbons of color.  It’s been nice and cool here, so all the blossoms are lasting for weeks and weeks.  Hope your weekend was relaxing and re-energizing, so the week ahead goes smoothly.

 

 

From Our Table to Yours !

 

Bon Appetit!

 

FDA Approves New Drug For Chronic Lymphocytic Leukemia In Patients With A Specific Chromosomal Abnormality

 

Congratulations to our colleagues at Abbott Molecular Diagnostics and AbbVie on this approval.

 

According to the National Cancer Institute, chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adults, with approximately 15,000 new cases diagnosed each year. CLL is characterized by the progressive accumulation of abnormal lymphocytes. Patients with CLL who have a 17p deletion lack a portion of the chromosome that acts to suppress cancer growth. This chromosomal abnormality occurs in approximately 10% of patients with untreated CLL and in approximately 20% of patients with relapsed CLL.

 

The FDA approved Venclexta (venetoclax) for the treatment of patients with CLL who have the chromosomal abnormality 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein

 

The efficacy of Venclexta was tested in a single-arm clinical trial of 106 patients with CLL who have a 17p deletion and who had received at least one prior therapy. Trial participants took Venclexta orally every day, beginning with 20 mg and increasing over a five-week period to 400 mg. Results showed that 80% of trial participants experienced a complete or partial remission of their cancer.

 

Venclexta is indicated for daily use after detection of 17p deletion is confirmed through the use of the FDA-approved companion diagnostic Vysis CLL FISH probe kit.

 

The most common side effects of Venclexta include low white blood cell count (neutropenia), diarrhea, nausea, anemia, upper respiratory tract infection, low platelet count (thrombocytopenia) and fatigue. Serious complications can include pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia and metabolic abnormalities known as tumor lysis syndrome. Live attenuated vaccines should not be given to patients taking Venclexta.

 

The FDA granted the Venclexta application breakthrough therapy designation, priority review status, and accelerated approval for this indication. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions. Venclexta also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.

 

Venclexta is manufactured by AbbVie Inc. of North Chicago, Illinois, and marketed by AbbVie and Genentech USA Inc. of South San Francisco, California. The Vysis CLL FISH probe kit is manufactured by Abbott Molecular of Des Plaines, Illinois.