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Shrimp Appetizer

November 12, 2018

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Target Healthy Eating

This is a delicious appetizer because of the sauce. It's attractive to serve the shrimp in real shells that wash well. I bought them on Amazon for very little. ©Joyce Hays, Target Health Inc.
Here's a close-up. The garnish is tiny pieces of fresh parsley and some extra salmon roe, that is the main ingredient of the sauce. ©Joyce Hays, Target Health Inc.
I've experimented a lot with this recipe. Here is one of the first attempts, which turned out very well. The red garnish, here, is a tiny piece of fresh tomato. ©Joyce Hays, Target Health Inc.
Part of experimenting with this recipe was to try the sauce with cooked scallops. It was good and if you love scallops, give it a try. We liked the combo of shrimp & sauce best. ©Joyce Hays, Target Health Inc.

Ingredients

13 slices of sour dough bread, crust removed, cold water to cover

1/2 cup extra virgin olive oil

1 fresh garlic clove, sliced

1 onion, roughly chopped

Zest of 1 lemon

Juice of 1 large lemon

1 cup orange salmon roe

1 pinch chili flakes

Very few ingredients. The shrimp were still in the fridge. ©Joyce Hays, Target Health Inc.

Directions

1. Place bread in a bowl, cover with water and let sit until the bread is well soaked, 5 to 10 minutes. Drain water from the bowl and squeeze all of the excess water from the bread. Pour water out of bowl.  With your hands, squeeze bread while still in bowl, to get more water out. Finally, place all the bread in a clean kitchen towel (not paper towel) and squeeze some more until more water is out of the bread.

2. While bread is soaking, get out a small skillet, turn heat to medium, add some of the olive oil, then the onion, garlic and chili flakes.  Saut? until the onion and garlic are soft and golden.

3. You need all of the olive oil in the skillet, and the chili flakes, so use a spatula to scrape everything out of the skillet and into a food processor.

4. To the food processor, add the rest of the olive oil, using a spatula to scrape the rest out of the measuring cup.

5. Slowly add the bread, while pulsing, the zest, and the lemon juice. Process until you get a very smooth consistency.

6. Finally, add the fish roe and continue to pulse until all the ingredients are well combined and smooth.

After you treat the bread and saute the onion, garlic and chili flakes, the sauce is made in a food processor. The sauce is the star of this new recipe. ©Joyce Hays, Target Health Inc.

7. Use your spatula to scrape every little bit of sauce, out of the food processor and into a small bowl.  Set aside on the kitchen table, for use later.

Sauce is made. Guests will arrive soon, so time to quickly cook the shrimp in a skillet, in hot olive oil with some fresh garlic cloves, stir the shrimp until they become pink but still crunchy and not rubbery. They will only get rubbery, if you cook them too long. Cook no more than 1 minute in hot oil on each side. ©Joyce Hays, Target Health Inc.
Add about one and a half Tablespoons of sauce to a shell, then arrange the (5 or 6 medium size) shrimp on each shell on the sauce. Finally, garnish with parsley and/or salmon roe, or tiny tomato bits of a tiny piece of fresh lime and/or lemon. ©Joyce Hays, Target Health Inc.
Close-up of last bite. ©Joyce Hays, Target Health Inc.
Your favorite, well-chilled white wine, will go well with the shrimp appetizer. ©Joyce Hays, Target Health Inc.

From Our Table to Yours

Have a Great Week Everyone!

Bon Appetit!

FDA Authorizes Emergency Use of First Ebola Fingerstick Test with Portable Reader

November 12, 2018

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Regulatory

The FDA has issued an emergency use authorization (EUA) for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary "fingerstick" whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD.

According to FDA, this EUA is part of the agency's ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis or treat available as quickly as possible. FDA added that it is committed to helping the people of the Democratic Republic of the Congo (DRC) effectively confront and end the current Ebola outbreak. The FDA's EUA authority allows the agency to authorize the use of an unapproved medical product, or the unapproved use of an approved medical product when, among other circumstances, there are no adequate, approved and available alternatives. When circumstances exist justifying authorization, the EUA becomes an important mechanism that allows broader access to medical products that have not been FDA cleared or approved and are instead only authorized for use for the duration of an emergency declaration. The FDA's criteria for issuing an EUA for a diagnostic test includes making an assessment that it is reasonable to believe, based on the totality of evidence available to the agency, that the test may be effective and the known and potential benefits of using the test outweigh its known and potential risks.

In 2014, during the Ebola outbreak in West Africa, an emergency was declared by the Secretary of Health and Human Services. While that outbreak has ended, ongoing, smaller Ebola outbreaks have continued, and the emergency declaration is still in place. Recent outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of an EUA for the DPP Ebola Antigen System is an important step in addressing these outbreaks.

The DPP Ebola Antigen System provides rapid diagnostic results with tests that can be performed in locations where a healthcare provider does not have access to authorized Ebola virus nucleic acid tests (PCR testing), which are highly sensitive but can only be performed in certain laboratory settings that are adequately equipped. The DPP Ebola Antigen System has been authorized for use with capillary “fingerstick“ whole blood, ethylenediaminetetraacetic acid (EDTA, an anticoagulant added to whole blood to prevent coagulation) venous whole blood and EDTA plasma. The DPP Ebola Antigen System should only be run in facilities, including treatment centers and public health clinics where patients are likely to be treated, and laboratories that are adequately equipped, trained and capable of such testing.

According to FDA, while this authorization will increase access to diagnostic tools for healthcare providers who may not have otherwise been equipped to perform tests, it is important to note that a negative result from the DPP Ebola Antigen System, especially in patients with signs and symptoms of EVD, should not be used as the sole basis for patient management decisions. The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus. The FDA added that it remains committed to using its authorities and resources to advance the development of countermeasures to address emerging threats and recently outlined its efforts to help address Ebola virus outbreaks. The FDA will also continue to work with its federal partners and potential commercial product manufacturers in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola virus disease for emergency use during this and any future outbreak.

With the issuance of the EUA for the DPP Ebola Antigen System to Chembio Diagnostic Systems Inc., the FDA has now issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for Ebola virus detection in human specimens.

Gene Mutation Points to New Way to Fight Diabetes, Obesity, Heart Disease

November 12, 2018

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Genetics

According to an article published in the Journal of the American College of Cardiology (15 October 2018), a gene mutation may have been discovered that slows the metabolism of sugar in the gut, giving people who have the mutation a distinct advantage over those who do not. Results showed that those with the mutation have a lower risk of diabetes, obesity, heart failure, and even death. The authors state that their finding could provide the basis for drug therapies that could mimic the workings of this gene mutation, offering a potential benefit for the millions of people who suffer with diabetes, heart disease, and obesity. This is the first to fully evaluate the link between mutations in the gene mainly responsible for absorbing glucose in the gut-SGLT-1, or sodium glucose co-transporter-1-and cardiometabolic disease. The authors added that people who have the natural gene mutation appear to have an advantage when it comes to diet, and that those who eat a high-carbohydrate diet and have this mutation will absorb less glucose than those without the mutation. A high-carbohydrate diet includes such foods as pasta, breads, cookies, and sugar-sweetened beverages.

For the study, the authors analyzed the relationship between SGLT-1 mutations and cardiometabolic disease using genetic data obtained from 8,478 participants in the Atherosclerosis Risk In Communities (ARIC) study. The study was a 25-year-long observational trial of atherosclerosis and cardiovascular risk factors in people living in four U.S. communities. Results showed that about 6% of the subjects carried a mutation in SGLT-1 that causes limited impairment of glucose absorption, and that individuals with this mutation had a lower incidence of type 2 diabetes, were less obese, had a lower incidence of heart failure, and had a lower mortality rate when compared to those without the mutation, even after adjusting for dietary intake (including total calories, sodium, and sugars). Based on these findings, the authors suggested that selectively blocking the SGLT-1 receptor could provide a way to slow down glucose uptake to prevent or treat cardiometabolic disease and its consequences. The authors did caution, however, that development of such targeted drugs could take years and that clinical trials are still needed to determine if the drugs reduce the incidence of diabetes and heart failure and improve lifespan.

Soy Formula Feeding During Infancy Associated with Severe Menstrual Pain in Adulthood

November 12, 2018

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Pediatrics

According to a study published online in the journal Human Reproduction (9 November 2018), results suggest that infant girls fed soy formula are more likely to develop severe menstrual pain as young adults. The finding adds to the growing body of literature that suggests exposure to soy formula during early life may have detrimental effects on the reproductive system.

For the study, data was examined from 1,553 African-American women, aged 23-35, participating in the NIEHS Study of Environment, Lifestyle, and Fibroids (SELF). Results showed that women who had ever been fed soy formula as babies were 50% more likely to have experienced moderate or severe menstrual discomfort between the ages of 18 and 22, and 40% more likely to have used hormonal contraception to help alleviate menstrual pain. The authors offered a potential explanation for the association between soy formula and severe menstrual pain. Data from previous laboratory animal studies suggest that early-life exposure to genistein, a naturally occurring component in soy formula, interferes with the development of the reproductive system, including factors involved in menstrual pain. These studies have also shown that developmental changes can continue into adulthood. However, severe menstrual pain is not the only adverse reproductive health condition that was linked to infant soy formula. Previously data have linked soy formula feeding to endometriosis, a condition where tissue that normally lines the inside of the uterus grows outside. Using SELF data, a link has also been shown with infant soy formula to larger fibroids among woman with fibroids, and to heavy menstrual bleeding. The only other research that evaluated soy formula in relation to menstrual pain was published in 2001 by scientists at the University of Pennsylvania, Philadelphia, and the University of Iowa, Iowa City. The study, which primarily included white young adults who participated in feeding studies when they were infants, also found an association between soy formula feeding and severe menstrual pain in the women. According to the authors, the results of both studies indicate that the findings may apply to all women, but further research is warranted before any changes are made to soy formula feeding recommendations.

The American Academy of Pediatrics (AAP) promotes human milk as the ideal source of nutrition for infants. It does not recommend soy formula for babies born prematurely. For full term infants, the AAP recommends soy formula in rare cases where the child's body cannot break down the sugars in milk or if the family prefers a vegetarian diet.

Charles Robert Darwin (1809 - 1882) Part 1

November 12, 2018

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History of Medicine

Photo thought to have been taken in 1854 and nearly destroyed by fire; however, salvaged. In this year, he was preparing On the Origin of Species for publication. Three quarter length studio photo showing Darwin's characteristic large forehead and bushy eyebrows with deep set eyes, pug nose and mouth set in a determined look. He is bald on top, with dark hair and long side whiskers but no beard or moustache. His jacket is dark, with very wide lapels, and his trousers are a light check pattern. His shirt has an upright wing collar, and his cravat is tucked into his waistcoat which is a light fine checked pattern.
Photo credit: Wikimedia Commons-This work is in the public domain in the United States because it was published (or registered with the U.S. Copyright Office) before January 1, 1923.

Charles Darwin was an English naturalist, geologist and biologist, whose revolutionary theory laid the foundation for both the modern theory of evolution and the principle of common descent by proposing natural selection as a mechanism. He published this proposal in 1859 in the book The Origin of Species, which remains his most famous work. He established that all species of life have descended over time from common ancestors and, in a joint publication with Alfred Russel Wallace, introduced his scientific theory that this branching pattern of evolution resulted from a process that he called natural selection, in which the struggle for existence has a similar effect to the artificial selection involved in selective breeding. Although Darwin acknowledged a struggle for existence, he made it well known that he considered the success (so far), of the human species to be based, far more, on cooperation than on competition. Toward the end of his life, Charles Darwin, in his letters, discussed the importance of a child's education (as well as having educated parents) in the struggle for survival. Although from a privileged background, Darwin looked at the way in which whole species survived. If alive today, he would have applauded free education for all, from the cradle to the grave.

Darwin published his theory of evolution with compelling evidence in his 1859 book On the Origin of Species, overcoming scientific rejection of earlier concepts of transmutation of species. By the 1870s, the scientific community and a majority of the educated public had accepted evolution as a fact. However, many favored competing explanations and it was not until the emergence of the modern evolutionary synthesis from the 1930s to the 1950s that a broad consensus developed in which natural selection was the basic mechanism of evolution. Darwin's scientific discovery is the unifying theory of the life sciences, explaining the diversity of life. Darwin's early interest in nature led him to neglect his medical education at the University of Edinburgh; instead, he helped to investigate marine invertebrates. Studies at the University of Cambridge (Christ's College) encouraged his passion for natural science.

His five-year voyage on HMS Beagle established him as an eminent geologist whose observations and theories supported Charles Lyell's uniformitarian ideas, and publication of his journal of the voyage made him famous as a popular author. Puzzled by the geographical distribution of wildlife and fossils he collected on the voyage, Darwin began detailed investigations, and in 1838 conceived his theory of natural selection. Although he discussed his ideas with several naturalists, he needed time for extensive research and his geological work had priority. He was writing up his theory, when in 1858 Alfred Russel Wallace sent him an essay that described the same idea, prompting immediate joint publication of both of their theories. Darwin's work established evolutionary descent with modification as the dominant scientific explanation of diversification in nature. In 1871 he examined human evolution and selection in The Descent of Man, followed by The Expression of the Emotions in Man and Animals (1872). His research on plants was published in a series of books, and in his final book, The Formation of Vegetable Mold, through the Actions of Worms (1881), he examined earthworms and their effect on soil.

Darwin has been described as one of the most influential figures in human history, and he was honored by burial in Westminster Abbey. Charles Robert Darwin was born in Shrewsbury, Shropshire, on 12 February 1809, at his family's home, The Mount. He was the fifth of six children of wealthy society doctor and financier Robert Darwin and Susannah Darwin (nee Wedgwood). He was the grandson of two prominent abolitionists: Erasmus Darwin on his father's side, and Josiah Wedgwood on his mother's side.

Darwin spent the summer of 1825 as an apprentice doctor, helping his father treat the poor of Shropshire, before going to the University of Edinburgh Medical School (at the time the best medical school in the UK) with his brother Erasmus in October 1825. Darwin found lectures dull and surgery distressing, so he neglected his studies. He learned taxidermy in around 40 daily hour-long sessions from John Edmonstone, a freed black slave who had accompanied Charles Waterton in the South American rainforest. In Darwin's second year at the university he joined the Plinian Society, a student natural-history group featuring lively debates in which radical democratic students with materialistic views challenged orthodox religious concepts of science. He assisted Robert Edmond Grant's investigations of the anatomy and life cycle of marine invertebrates in the Firth of Forth, and on 27 March 1827 presented at the Plinian, his own discovery that black spores found in oyster shells were the eggs of a skate leech. One day, Grant praised Lamarck's evolutionary ideas. Darwin was astonished by Grant's audacity, but had recently read similar ideas of evolution, in his grandfather Erasmus' journals. Darwin was rather bored by Robert Jameson's natural-history course, which covered geology - including the debate between Neptunism and Plutonism. He learned the classification of plants, and assisted with work on the collections of the University Museum, one of the largest museums in Europe at the time. Darwin's neglect of medical studies annoyed his father, who shrewdly sent him to Christ's College, Cambridge, to study for a Bachelor of Arts degree as the first step towards becoming an Anglican country parson. As Darwin was unqualified for the Tripos, he joined the ordinary degree course in January 1828. He preferred riding and shooting to studying. His cousin William Darwin Fox introduced him to the popular craze for beetle collecting; Darwin pursued this zealously, getting some of his finds published in James Francis Stephens' Illustrations of British entomology. He became a close friend and follower of botany professor John Stevens Henslow and met other leading parson-naturalists who saw scientific work as religious natural theology, becoming known to these dons as "the man who walks with Henslow". Darwin had to stay at Cambridge until June 1831. He studied Paley's Natural Theology or Evidences of the Existence and Attributes of the Deity (first published in 1802), which made an argument for divine design in nature, explaining adaptation as God acting through laws of nature. He read John Herschel's new book, Preliminary Discourse on the Study of Natural Philosophy (1831), which described the highest aim of natural philosophy as understanding such laws through inductive reasoning based on observation, and Alexander von Humboldt's Personal Narrative of scientific travels in 1799-1804. Inspired with "a burning zeal" to contribute, Darwin planned to visit Tenerife with some classmates after graduation, to study natural history in the tropics.

Click on link to check voyage of Beagle (1831-1836) on world map.

After leaving Sedgwick in Wales, Darwin spent a week with student friends at Barmouth, then returned home on 29 August to find a letter from Henslow proposing him as a suitable (if unfinished) naturalist for a self-funded supernumerary place on HMS Beagle with captain Robert FitzRoy, emphasizing that this was a position for a gentleman rather than "a mere collector". The ship was to leave in four weeks on an expedition to chart the coastline of South America. Robert Darwin objected to his son's planned two-year voyage, regarding it as a waste of time, but was persuaded by his brother-in-law, Josiah Wedgwood II, to agree to (and fund) his son's participation. Darwin took care to remain in a private capacity to retain control over his collection, intending it for a major scientific institution. After delays, the voyage began on 27 December 1831; it lasted almost five years. As FitzRoy had intended, Darwin spent most of that time on land investigating geology and making natural history collections, while HMS Beagle surveyed and charted coasts. He kept careful notes of his observations and theoretical speculations, and at intervals during the voyage his specimens were sent to Cambridge together with letters including a copy of his journal for his family. He had some expertise in geology, beetle collecting and dissecting marine invertebrates, but in all other areas was a novice and ably collected specimens for expert appraisal. Despite suffering badly from seasickness, Darwin wrote copious notes while on board the ship. Most of his zoology notes are about marine invertebrates, starting with plankton collected in a calm spell.

On their first stop ashore at St Jago in Cape Verde, Darwin found that a white band high in the volcanic rock cliffs included seashells. FitzRoy had given him the first volume of Charles Lyell's Principles of Geology, which set out uniformitarian concepts of land slowly rising or falling (evolving) over immense periods, and Darwin saw things Lyell's way, theorizing and thinking of writing a book on geology. When they reached Brazil, Darwin was delighted by the tropical forest, but detested the sight of slavery, and disputed this issue with Fitzroy. The survey continued to the south in Patagonia. They stopped at Bah?a Blanca, and in cliffs near Punta Alta Darwin made a major find of fossil bones of huge extinct mammals beside modern seashells, indicating recent extinction with no signs of change in climate or catastrophe. He identified the little-known Megatherium by a tooth and its association with bony armor, which had at first seemed to him to be like a giant version of the armor on local armadillos. The finds brought great interest when they reached England. On rides with gauchos into the interior to explore geology and collect more fossils, Darwin gained social, political and anthropological insights into both native and colonial people at a time of revolution, and learnt that two types of rhea had separate but overlapping territories. Further south, he saw stepped plains of shingle and seashells as raised beaches showing a series of elevations. He read Lyell's second volume and accepted its view of “centers of creation“ of species, but his discoveries and theorizing challenged Lyell's ideas of smooth continuity and of extinction of species. As HMS Beagle surveyed the coasts of South America, Darwin theorized about geology and extinction of giant mammals.

Three Fuegians on board had been seized during the first Beagle voyage, then during a year in England were educated as missionaries. Darwin found them friendly and civilized, yet at Tierra del Fuego he met "miserable, degraded savages", as different as wild from domesticated animals. He remained convinced that, despite this diversity, all humans were interrelated with a shared origin and potential for improvement towards civilization. Unlike his scientist friends, he now thought there was no unbridgeable gap between humans and animals. A year on, the mission had been abandoned. The Fuegian they had named Jemmy Button lived like the other natives, had a wife, and had no wish to return to England. Darwin experienced an earthquake in Chile and saw signs that the land had just been raised, including mussel-beds stranded above high tide. High in the Andes he saw seashells, and several fossil trees that had grown on a sand beach. He theorized that as the land rose, oceanic islands sank, and coral reefs round them grew to form atolls. On the geologically new Galapagos Islands, Darwin looked for evidence attaching wildlife to an older "center of creation", and found mockingbirds allied to those in Chile but differing from island to island. He heard that slight variations in the shape of tortoise shells showed which island they came from, but failed to collect them, even after eating tortoises taken on board as food. In Australia, the marsupial rat-kangaroo and the platypus seemed so unusual that Darwin thought it was almost as though two distinct Creators had been at work. He found the Aborigines "good-humored & pleasant", and noted their depletion by European settlement.

FitzRoy investigated how the atolls of the Cocos (Keeling) Islands had formed, and the survey supported Darwin's theorizing. FitzRoy began writing the official Narrative of the Beagle voyages, and after reading Darwin's diary he proposed incorporating it into the account. Darwin's Journal was eventually rewritten as a separate third volume, on natural history. In Cape Town, Darwin and FitzRoy met John Herschel, who had recently written to Lyell praising his uniformitarianism as opening bold speculation on "that mystery of mysteries, the replacement of extinct species by others" as "a natural in contradistinction to a miraculous process". When organising his notes as the ship sailed home, Darwin wrote that, if his growing suspicions about the mockingbirds, the tortoises and the Falkland Islands fox were correct, "such facts undermine the stability of Species", then cautiously added "would" before "undermine". He later wrote that such facts "seemed to me to throw some light on the origin of species".

Darwin's father organized investments, enabling his son to be a self-funded gentleman scientist, and an excited Darwin went around the London institutions being feted and seeking experts to describe the collections of biological sample. Zoologists had a huge backlog of work, and there was a danger of specimens just being left in storage. Charles Lyell eagerly met Darwin for the first time on 29 October and soon introduced him to the up-and-coming anatomist Richard Owen, who had the facilities of the Royal College of Surgeons to work on the fossil bones collected by Darwin. Owen's surprising results included other gigantic extinct ground sloths as well as the Megatherium, a near complete skeleton of the unknown Scelidotherium and a hippopotamus-sized rodent-like skull named Toxodon resembling a giant capybara. The armor fragments were actually from Glyptodon, a huge armadillo-like creature as Darwin had initially thought. These extinct creatures were related to living species in South America. In mid-December, Darwin took lodgings in Cambridge to organize work on his collections and rewrite his Journal. He wrote his first paper, showing that the South American landmass was slowly rising, and with Lyell's enthusiastic backing read it to the Geological Society of London on 4 January 1837. On the same day, he presented his mammal and bird specimens to the Zoological Society. The ornithologist John Gould soon announced that the Galapagos birds that Darwin had thought a mixture of blackbirds, "gros-beaks" and finches, were, in fact, twelve separate species of finches. On 17 February, Darwin was elected to the Council of the Geological Society, and Lyell's presidential address presented Owen's findings on Darwin's fossils, stressing geographical continuity of species as supporting his uniformitarian ideas. Gould met Darwin and told him that the Galapagos mockingbirds from different islands were separate species, not just varieties, and what Darwin had thought was a "wren" was also in the finch group. Darwin had not labelled the finches by island, but from the notes of others on the ship, including FitzRoy, he allocated species to islands. The two rheas were also distinct species, and on 14 March Darwin announced how their distribution changed going southwards.

In mid-July 1837 Darwin started his "B" notebook on Transmutation of Species, and on page 36 wrote "I think" above his first evolutionary tree. By mid-March, Darwin was speculating in his Red Notebook on the possibility that "one species does change into another" to explain the geographical distribution of living species such as the rheas, and extinct ones such as the strange Macrauchenia, which resembled a giant guanaco. His thoughts on lifespan, asexual reproduction and sexual reproduction developed in his "B" notebook around mid-July on to variation in offspring "to adapt & alter the race to changing world" explaining the Gal?pagos tortoises, mockingbirds and rheas. He sketched branching descent, then a genealogical branching of a single evolutionary tree, in which "It is absurd to talk of one animal being higher than another", discarding Lamarck's independent lineages progressing to higher forms. While developing this intensive study of transmutation, Darwin became mired in more work. Still rewriting his Journal, he took on editing and publishing the expert reports on his collections, and with Henslow's help obtained a Treasury grant to sponsor this multi-volume Zoology of the Voyage of H.M.S. Beagle. He stretched the funding to include his planned books on geology, and agreed to unrealistic dates with the publisher. As the Victorian era began, Darwin pressed on with writing his Journal, and in August 1837 began correcting printer's proofs.

Darwin's health suffered under the pressure. On 20 September he had "an uncomfortable palpitation of the heart", so his doctors urged him to "knock off all work" and live in the country for a few weeks. After visiting Shrewsbury he joined his Wedgwood relatives at Maer Hall, Staffordshire, but found them too eager for tales of his travels to give him much rest. His charming, intelligent, and cultured cousin Emma Wedgwood, nine months older than Darwin, was nursing his invalid aunt. His uncle Josiah pointed out an area of ground where cinders had disappeared under loam and suggested that this might have been the work of earthworms, inspiring "a new & important theory" on their role in soil formation, which Darwin presented at the Geological Society on 1 November. William Whewell pushed Darwin to take on the duties of Secretary of the Geological Society. After initially declining the work, he accepted the post in March 1838. Despite the grind of writing and editing the Beagle reports, Darwin made remarkable progress on transmutation, taking every opportunity to question expert naturalists and, unconventionally, people with practical experience such as farmers and pigeon fanciers. Over time, his research drew on information from his relatives and children, the family butler, neighbors, colonists and former shipmates. He included mankind in his speculations from the outset, and on seeing an orangutan in the zoo on 28 March 1838 noted its childlike behavior. The strain took a toll, and by June he was being laid up for days on end with stomach problems, headaches and heart symptoms. For the rest of his life, he was repeatedly incapacitated with episodes of stomach pains, vomiting, severe boils, palpitations, trembling and other symptoms, particularly during times of stress, such as attending meetings or making social visits. The cause of Darwin's illness remained unknown, and attempts at treatment had little success.

Continuing his research in London, Darwin's wide reading now included the sixth edition of Malthus's An Essay on the Principle of Population, and on 28 September 1838 he noted its assertion that human "population, when unchecked, goes on doubling itself every twenty five years, or increases in a geometrical ratio", a geometric progression so that population soon exceeds food supply in what is known as a Malthusian catastrophe. Darwin was well prepared to compare this to de Candolle's "warring of the species" of plants and the struggle for existence among wildlife, explaining how numbers of a species kept roughly stable. As species always breed beyond available resources, favorable variations would make organisms better at surviving and passing the variations on to their offspring, while unfavorable variations would be lost. He wrote that the "final cause of all this wedging, must be to sort out proper structure, & adapt it to changes", so that "One may say there is a force like a hundred thousand wedges trying force into every kind of adapted structure into the gaps of in the economy of nature, or rather forming gaps by thrusting out weaker ones." This would result in the formation of new species. As he later wrote in his Autobiography:

"In October 1838, that is, fifteen months after I had begun my systematic enquiry, I happened to read for amusement Malthus on Population, and being well prepared to appreciate the struggle for existence which everywhere goes on from long-continued observation of the habits of animals and plants, it at once struck me that under these circumstances favorable variations would tend to be preserved, and unfavorable ones to be destroyed. The result of this would be the formation of new species. Here, then, I had at last got a theory by which to work"

By mid-December, Darwin saw a similarity between farmers picking the best stock in selective breeding, and a Malthusian Nature selecting from chance variants so that "every part of newly acquired structure is fully practical and perfected", thinking this comparison "a beautiful part of my theory". He later called his theory natural selection, an analogy with what he termed the artificial selection of selective breeding.

Darwin now had the framework of his theory of natural selection "by which to work", as his "prime hobby". His research included extensive experimental selective breeding of plants and animals, finding evidence that species were not fixed and investigating many detailed ideas to refine and substantiate his theory. For fifteen years this work was in the background to his main occupation of writing on geology and publishing expert reports on the Beagle collections. When FitzRoy's Narrative was published in May 1839, Darwin's Journal and Remarks was such a success as the third volume that later that year it was published on its own. Early in 1842, Darwin wrote about his ideas to Charles Lyell, who noted that his ally "denies seeing a beginning to each crop of species". Darwin's book The Structure and Distribution of Coral Reefs on his theory of atoll formation was published in May 1842 after more than three years of work, and he then wrote his first "pencil sketch" of his theory of natural selection. To escape the pressures of London, the family moved to rural Down House in September. On 11 January 1844, Darwin mentioned his theorizing to the botanist Joseph Dalton Hooker, writing with melodramatic humor "it is like confessing a murder". Hooker replied "There may in my opinion have been a series of productions on different spots, & also a gradual change of species. I shall be delighted to hear how you think that this change may have taken place, as no presently conceived opinions satisfy me on the subject."

Meniere's Disease

November 12, 2018

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Quiz

The labyrinth in relation to the ear: The labyrinth is composed of the semicircular canals, the otolithic organs (i.e., utricle and saccule), and the cochlea. Inside their walls (bony labyrinth) are thin, pliable tubes and sacs (membranous labyrinth) filled with endolymph. Credit: NIH/NIDCD

It has been speculated that 1) ___ Darwin suffered from Meniere's disease among other illnesses. Meniere's disease (MD) is a disorder of the inner ear that is characterized by episodes of feeling like the world is spinning, referred to as2) ___. Other symptoms include, ringing in the ears (tinnitus), hearing loss, and a fullness in the ear. Typically, only one ear is affected, at least initially; however, over time both ears may become involved. Episodes generally last from 20 minutes to a few hours. The time between episodes varies. The hearing loss and ringing in the 3) ___ may become constant over time. The cause of Meniere's disease is unclear but likely involves both genetic and environmental factors. A number of theories exist for why it occurs including constrictions in 4) ___ vessels, viral infections, and autoimmune reactions. About 10% of cases run in families. Symptoms are believed to occur as the result of increased fluid build-up in the labyrinth of the inner ear. Diagnosis is based on the symptoms and frequently a hearing 5) ___. Other conditions that may produce similar symptoms include vestibular migraine and transient ischemic attack. There is no known cure. Attacks are often treated with medications to help with the nausea and anxiety. Measures to prevent attacks are overall poorly supported by the evidence. A low salt diet, diuretics, and corticosteroids may be tried. Physical therapy may help with balance and counselling may help with anxiety. Injections into the ear or surgery may also be tried if other measures are not effective but are associated with more 6)___ than benefit. The use of tympanostomy tubes, while popular, is not supported.

Meniere's disease was first identified in the early 1800s by Prosper Meniere. It affects between 0.3 and 1.9 per 1,000 people. It most often starts in people 40 to 60 years old. 7) ____ are more commonly affected than males. After 5 to 15 years of symptoms, the episodes of the world spinning generally stop and the person is left with mild loss of balance, moderately poor hearing in the affected ear, and ringing in their ear. Meniere's is characterized by recurrent episodes of vertigo, hearing loss and tinnitus; episodes may be accompanied by a headache and a feeling of fullness in the ears. People may also experience additional symptoms related to irregular reactions of the autonomic nervous8) ___. These symptoms are not symptoms of Meniere's disease per se, but rather are side effects resulting from failure of the organ of hearing and balance, and include nausea, vomiting, and sweating?which are typically symptoms of vertigo, and not of Meniere's. This includes a sensation of being pushed sharply to the floor from behind. Sudden falls without loss of consciousness (drop attacks) may be experienced by some people.

The cause of Meniere's disease is unclear but likely involves both 9) ___ and environmental factors. A number of theories exist including constrictions in blood vessels, viral infections, autoimmune reactions. The initial triggers of Meniere's disease are not fully understood, with a variety of potential inflammatory causes that lead to endolymphatic hydrops (EH), a distension of the endolymphatic spaces in the inner ear. EH, in turn, is strongly associated with developing Meniere's disease, but not everyone with EH develops Meniere's disease: "The relationship between endolymphatic hydrops and Meniere's disease is not a simple, ideal correlation." Additionally, in fully developed Meniere's disease the balance system (vestibular system) and the hearing system (cochlea) of the inner ear are affected, but there are cases where EH affects only one of the two systems strong enough to cause symptoms. The corresponding subtypes of Meniere's disease are called vestibular Meniere's disease, showing symptoms of vertigo, and cochlear Meniere's disease, showing symptoms of hearing loss and tinnitus. The mechanism of Meniere's disease is not fully explained by EH, but fully developed EH may mechanically and chemically interfere with the sensory cells for balance and hearing, which can lead to temporary dysfunction and even to death of the sensory 10)___, which in turn can cause the typical symptoms of Meniere's disease: vertigo, hearing loss, and tinnitus.

ANSWERS: 1) Charles; 2) vertigo; 3) ears; 4) blood; 5) test; 6) risk; 7) Females; 8) system; 9) genetic; 10) cells

Crabtree Falls - Another James Farley Masterpiece

November 12, 2018

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What's New

Our good friend and colleague James Farley, photographer extraordinaire and of course a top Director of Data Management and Programming, has again shared another masterpiece.  

Here is what James wrote:

Crabtree Falls is an iconic waterfall, found along the Blue Ridge Parkway. I hiked this location a couple years ago, but quite honestly was not very happy with the results of my efforts. I've wanted to return again and this trip yielded a much better result. Color was ideal and I worked very hard to find a vantage point that suited my taste in composition. If you have not visited these falls, it is worth the time. The experience is fantastic, as the falls are impressive in size and the multiple cascades in the water are fascinating.

Crabtree Falls. ©Advanced Fine Arts 2018

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.

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

Autumn Salad Using Golden Beets, Green & Red Greens, Dates, Cheese

November 4, 2018

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Target Healthy Eating

The flavor is as good as the visual. I've tried many times to get a delicious and unique beet salad. Finally, I thought I had it with a combo of red and golden, but the red quickly discolored the beautiful golden beets. Finally, I went for red salad leaves and left the red beets out. Here is the final result which I heard everyone loved. ©Joyce Hays, Target Health Inc.
Certain flowers, like this pansy, are edible. ©Joyce Hays, Target Health Inc.
The dates, egg whites and toasted pistachios, went well with the goat cheese and or course with the beautiful golden beets. ©Joyce Hays, Target Health Inc.

Ingredients

Beets

2 garlic cloves ground in mortar & pestle with 2 anchovy fillets

8 to 10 golden beets

1 inch ginger root, grated

2 scallions, chopped (not the darker green part)

2 shallots, chopped

10 pitted dates, chopped

3 to 5 Tablespoons extra virgin olive oil (to your taste)

2 hard-boiled eggs, use the white only, chopped well

2 Tablespoons aged Balsamic vinegar

1 pinch black pepper

1/2 cup pistachios, toasted, then chopped a little (not too much)

2 cups baby arugula and any small reddish leaf (don't marinate)

Mixed Goat Cheese Topping

1 scallion, well chopped

2 fresh garlic cloves, ground in mortar & pestle with 2 anchovies

1/2 cup fresh goat cheese

1 or 2 Tablespoons (you be the judge) almond milk

1 Tablespoon extra virgin olive oil

1 pinch black pepper

1 teaspoon champagne vinegar (or more to your taste)

1 inch ginger root, grated

Garnish

Find edible flowers. I got mine at FreshDirect

Here are the mixed greens that I bought from FreshDirect, and mixed them with baby arugula. The package doesn't give a name for the red leaves. However, they could be red spinach or a variety of Asian amaranth. ©Joyce Hays, Target Health Inc.
You must always wash salad greens at least twice, ending by draining, then pat dry with paper toweling. ©Joyce Hays, Target Health Inc.
The fresher the ingredients the better the outcome. ©Joyce Hays, Target Health Inc.

Directions

1. Preheat oven to 375 to 400 degrees.

2. Put a sheet of parchment on a baking sheet.

3. Scrub the beets under cold water. Trim any leaves, stems or roots and place on the baking sheet and roast the beets for 40 to 60 minutes, until a fork poking in, goes in very easily.

4. While beets are roasting, do all of your chopping, grinding, grating, etc.

5. Toast the pistachio nuts, then set aside.

6. Next, get out a large bowl and add all the ingredients, above, listed under Beet ingredients, except the salad greens and the nuts. Stir and set aside.

7. When beets are done, remove with oven mitts and put them where they can cool down completely (like 30 to 60 minutes)

8. Use a veggie peeler to remove outer rough skin. Cut beets into bite-size pieces, and try to make them square shaped.

9. Add the cut beet pieces to the large bowl with the beet ingredients. Cover with saran wrap. Stir well and marinate in the refrigerator overnight.

10. The next day, chop the nuts, if you haven't already.

11. In a bowl, add all the ingredients for the goat cheese topping. Whip until the dressing/topping is smooth with a silky consistency. Then put in fridge until ready to use.

12. In a salad serving bowl, (I like a glass salad bowl for this recipe), put all the washed (then dried with paper towel) red and green salad greens. Then pour all the contents of the golden beets over the greens. Sprinkle the top with the nuts and any edible flowers you were able to find.

13. You can either add a dollop of the topping over the beets in salad bowl. Or you can serve the topping and pass it around at the table. Toss at the table, before you serve, to get the greens, beets and dressing well combined.

14. Serve immediately.

I could not believe how good this salad turned out. It's really easy to make and look how beautiful it is. ©Joyce Hays, Target Health Inc.
At a dinner for six, over the weekend, we started with crudites, dip and wine in front of our Koi aquarium. Then moved to dining table for shrimp; next this Autumn Golden Beet Salad; then a chicken tagine, and a butternut squash/mushroom casserole. Dessert was a selection of sweets. Everyone went for the chocolate cake. ©Joyce Hays, Target Health Inc.
Each guest found a little finger puppet on their plate. But these guests didn't need a reminder to vote. ©Joyce Hays, Target Health Inc.
We served Pouilly-Fuisse and Cabernet Sauvignon ©Joyce Hays, Target Health Inc.

From Our Table to Yours

Have a Great Week Everyone!

Bon Appetit!

FDA Authorizes First Direct-to-Consumer Test for Detecting Genetic Variants That May Be Associated with Medication Metabolism

November 4, 2018

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Regulatory

Pharmacogenetics is the process of understanding what, if any, role genetics plays in a patient's reaction to drugs.

The FDA has permitted, with special controls, the marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test. This diagnostic provides information about genetic variants that may be associated with a patient's ability to metabolize some medications. The test detects 33 variants for multiple genes. The Personal Genome Service test analyzes DNA from a self-collected saliva sample, and the report describes if a person has variants in certain genes that may be associated with a patient's ability to metabolize some medicines.

The 23andMe Personal Genome Service Pharmacogenetic Reports test is not intended to provide information on a patient's ability to respond to any specific medication. The test does not describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug. Furthermore, health care providers should not use the test to make any treatment decisions. Results from this test should be confirmed with independent pharmacogenetic testing before making any medical decisions.

The FDA's review of the test determined, among other things, that the company provided data to show that the test is accurate (i.e., can correctly identify the genetic variants in saliva samples) and that it can provide reproducible results. The company submitted data on user comprehension studies that demonstrated that the test instructions and reports were understood by consumers. The test report provides information describing what the results might mean, what the test does not do and how to interpret results.

The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, clinical performance and labeling. For this category of device, the FDA established six special controls, including a labeling requirement that a warning statement must be included noting that the consumer should not use the test results to stop or change any medication. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.

The FDA granted the marketing authorization of the Personal Genome Service Pharmacogenetic Reports test to 23andMe.

Gut Bacteria May Control Movement

November 4, 2018

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Microbiome

Editor's note: This is a must read - According to the authors, “Gut bacteria may play a similar role in mammalian locomotion, and even in movement disorders such as Parkinson's disease. More research is needed to see whether bacteria control movement in other species, including mammals.“

A new study supports the role of the enteric brain. The findings, published in Nature (24 October 2018) suggest that gut bacteria may control movement in fruit flies and identify the neurons involved in this response. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS)

Interestingly, the authors observed that germ-free fruit flies, which did not carry bacteria, were hyperactive. For instance, they walked faster, over greater distances, and took shorter rests than flies that had normal levels of microbes. As a result, the authors decided to investigate ways in which gut bacteria may affect behavior in fruit flies. Since fruit flies carry between five and 20 different species of bacteria, the authors treated the germ-free animals with individual strains of those microbes. When the flies received Lactobacillus brevis, their movements slowed down to normal speed. L. brevis was one of only two species of bacteria that restored normal behavior in the germ-free flies.

The authors also discovered that the molecule xylose isomerase (Xi), a protein that breaks down sugar and is found in L. brevis, may be critical to this process. Isolating the molecule and treating germ-free flies with it was sufficient to slow down the speed-walkers. Additional experiments showed that Xi may regulate movement by fine-tuning levels of certain carbohydrates, such as trehalose, which is the main sugar found in flies and is similar to mammalian glucose. Flies that were given Xi had lower levels of trehalose than did untreated germ-free flies. When Xi-treated flies, which showed normal behavior, were given trehalose alone, they resumed fast movements suggesting that the sugar was able to reverse the effects of Xi.

Next, the authors looked into the flies' nervous system to see what cells were involved in bacteria-directed movement. When neurons were turned on that produce the chemical octopamine, that activation canceled out the effect of L. brevis on the germ-free flies. As a result, the flies, which had previously slowed down after receiving the bacterium or Xi, resumed their speed-walking behavior. Turning on octopamine-producing nerve cells in flies with normal levels of bacteria also caused them to move faster. However, activating neurons that produce other brain chemicals did not influence the flies' movements.

According to the authors, Xi may be monitoring the flies' metabolic state, including levels of nutrients, and then signaling to octopamine neurons whether they should turn on or off, resulting in changes in behavior. Instead of octopamine, mammals produce a comparable chemical called noradrenaline, which has been shown to control movement.

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