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Italian Veggie Balls, Served Over Pasta & Your Favorite Sauce

June 10, 2019

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Target Healthy Eating

If you like to include a meatless Monday (or additional veggie dinners) in your weekly menus, here is one of my most delicious veggie recipes. It has evolved over a period of two or three years to what I now call Italian Veggie Balls. The sauce I recommend is not my marinara sauce, published in our newsletter many years ago, but a more recent tomato sauce, published recently to serve with seafood. This sauce has rich depth and is also perfect for meat or meatless recipes. Whenever Jules travels, he takes with him a large container of these Italian Veggie Balls, which he gives a score of A+. We both love this dish and have it about once a week. ©Joyce Hays, Target Health Inc.

Ingredients

1 cup chickpea flour, to roll the balls in

1 cup quinoa

1 onion chopped

3 boxes mushrooms (cremini or Bella or white), well chopped

2 cups chicken stock or broth, or more if needed

Black pepper to your taste

4 eggs, whisked

1 cup Parmesan cheese, freshly grated

4 scallions, chopped

3 anchovy fillets ground in mortar & pestle with 3 fresh garlic cloves.  Grind into a paste

25 additional, fresh cloves garlic, minced

Pinch Kosher or sea salt

2 Tablespoons DRY oregano

2 Tablespoons fresh basil, very well chopped

2 Tablespoons fresh parsley, very well chopped

2 Tablespoons fresh cilantro, very well chopped

1 red chili, seeds removed, then chopped very well

1 or 2 pinches of chili flakes

4 cups steamed kale, chopped

1.5 cup Panko FLAKES OR crumbs

1 Tablespoon olive oil

Make your favorite marinara or tomato sauce

Make capellini or your favorite pasta

Freshly grate extra parmesan for the table

Extra basil leaves for garnish

Healthy and Easy to Find Ingredients.  ©Joyce Hays, Target Health Inc.

Directions

1.     Make your marinara or tomato sauce first or the night before.

2.     Make a paste of anchovy & garlic by grinding in mortar & pestle.  Set aside.

3.     Get a pot with salted water, out to make your pasta, later, after you make the veggie balls. You want the pasta to be freshly cooked and nice and warm, before serving.

4.     Rinse the kale leaves three times, before steaming, to get all the sand and grit out. After all the work cooking this wonderful recipe, it's terrible to sit down, take a bite, and have your teeth crunch down on even one grain of sand. So, rinse, drain; rinse, drain; rinse, drain.

5.     While you're rinsing the kale three times, do all of the cutting, chopping, grating, you need to do, so everything is ready for mixing, later.

Do all your cutting, slicing and chopping at the same time and on the same cutting board.  ©Joyce Hays, Target Health Inc.
Chopping the cilantro.  ©Joyce Hays, Target Health Inc.

5. After kale is rinsed and drained 3 times, steam it until it wilts and is reduced in volume.  Let it drain well before you use it.  In fact, before combining the kale with anything, after it drains well, give it a squeeze with paper towel so there's not too much liquid in the veggie ball mixture.

Steaming the kale.  ©Joyce Hays, Target Health Inc.

6. Rinse 1 cup of quinoa thoroughly and place the grains in a medium sauce pan with 2 cups of chicken stock or broth. Allow quinoa to soak for 15 minutes. Then, with the lid on the pan, bring the broth to a boil and reduce to a simmer. Cook until quinoa is tender and has absorbed the liquid - about 20 minutes. Let cool to room temp.

Cooked the quinoa.  ©Joyce Hays, Target Health Inc.

7. While the quinoa is cooking, get out a nice looking pan that you will bring to the table and serve from. In this pan, sautee the chopped mushrooms, onions, scallions, minced garlic, chili flakes, oregano and basil, in a mixture of olive oil and chicken broth or stock.  Sautee for about 5 minutes, stirring the whole time.

Sautee the mushrooms, onion, scallions, garlic, herbs and spices.  ©Joyce Hays, Target Health Inc.

8. When onions, scallions, mushrooms & garlic are done, use a spatula to scrape every bit of the mushroom mixture out of the pan and onto a cutting board.

9. With a large knife, chop the mushroom mixture into very small pieces, as small as you can.  I did not want to use a food processor here, because by making a paste in the processor, you will lose a certain texture, that adds to the flavor.

Above is in the middle of chopping the mushroom mixture.  The pieces need to get just a little smaller.  ©Joyce Hays, Target Health Inc.

10. Into the same mixing bowl, add the cooked quinoa, eggs, 1 cup of parmesan, red chili chopped, salt, steamed kale, Panko crumbs, chili flakes, all chopped herbs, and anything that you might have forgotten to add earlier. Let everything sit for a few minutes to absorb the liquid. You want the batter to be moist, but not runny.

Starting to make the batter; adding egg to the cooked quinoa in a large bowl.  ©Joyce Hays, Target Health Inc.
Here is what the batter should look like, done.  Now, you're ready to start making the Italian Veggie Balls. ©Joyce Hays, Target Health Inc.

11. Get a large pan out to cook the veggie meatballs.

12. Sprinkle a little chickpea flour on a plate.

13. With your hands, form little balls and roll them in the chickpea flour.

With your hands, take a fingerfull of the batter and roll balls about the size of golf balls.  Then roll those balls in the chickpea flour until they're completely covered with a thin film of the flour.  Then fry them in batches in a skillet with enough room to move them around, without breaking them. ©Joyce Hays, Target Health Inc.

14. Heat 1 Tablespoon olive oil in a large skillet over medium-low heat. Cook about 6 veggie balls at the same time. Cover the pan and let the veggie balls cook for about 5 minutes, then roll them around so more of the sides get a nice brown color.  Cook another 5 minutes until the other-sides are a deep rich brown.

Cook the Italian Veggie Balls in extra virgin olive oil with enough room in the pan to move them around.  ©Joyce Hays, Target Health Inc.

15. When each batch is done, put them on a plate, while you finish the rest.

16. When all the veggie meatballs are done and on a plate or in a serving bowl, fill the skillet with marinara sauce or other tomato sauce, over low flame. When sauce begins to simmer, put veggie balls in and warm everything up, so ready to serve over the pasta.

These Veggie Balls are done now and about to go into a pre-warmed serving bowl. ©Joyce Hays, Target Health Inc.
Into a pre-warmed serving bowl.  ©Joyce Hays, Target Health Inc.

17. On the table, set a trivet out and bring the pan with veggie meatballs to the table to serve (over the pasta).  Garnish the veggie balls with some of the chopped basil or parsley.

Getting hungry just looking at these photos. Such a yummy, flavorful meal ! We love this and hope you do too. ©Joyce Hays, Target Health Inc.
Good to the last bite.  Have your favorite bread with this meal, so you can sop up the wonderful sauce ©Joyce Hays, Target Health Inc.

Relatives came over for dinner this weekend.  We started with a variety of appetizers (shrimp cocktail, mushroom deviled eggs, stuffed mushrooms, baked cauliflower/potato tiny nibbles).  We were drinking nicely chilled Bellini's, they chose Paul Hobbs Cabernet. First course was a simple garden salad (my recipe published several years ago), with fresh lemon juice & olive oil, warm French baguette and European butter. Next, my recipe for spinach pie (published several years ago). The entree was Italian Veggie Balls with Capellini and an extraordinarily rich tomato sauce. (My recipe for this sauce was published recently). We had two desserts made at home: my apple cheese cake recipe (published recently in the newsletter) and a chocolate cake (recipe by the great London chef, Yotam Ottolenghi, from Israel).  Our late son, Alex, gave me a book of his recipes.

We actually drank Bellini's from start of evening to finish, but don't necessarily, recommend that. Because of the earthiness of the Italian Veggie Balls and the richness of the sauce, you could easily pair a full-bodied cabernet sauvignon or a chilled white, which you see in the photo above.  ©Joyce Hays, Target Health Inc.

From Our Table to Yours

Have a Great Week

Bon Appetit!

Treatment for Cluster Headaches Approved

June 10, 2019

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Regulatory

FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. The headaches are accompanied by symptoms that may include: bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Some people experience restlessness and agitation. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and three hours.

The FDA has approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults. The effectiveness of Emgality for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared the drug to placebo in 106 patients. The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the Emgality and placebo groups. During the three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for patients on placebo. There is a risk of hypersensitivity reactions with Emgality use. If a serious hypersensitivity reaction occurs, treatment should be discontinued. Hypersensitivity reactions could occur days after administration and may be prolonged. The most common side effect reported by participants in the clinical trials was injection site reactions.

Emgality is given by patient self-injection. It was first approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The FDA granted the approval of Emgality to Eli Lilly.

The FDA granted this application Priority Review and Breakthrough Therapy designation.

Children's Brains Reorganize After Epilepsy Surgery to Retain Visual Perception

June 10, 2019

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Neurology

Normal visual function requires not just information sent from the eye (sight), but also processing in the brain that allows us to understand and act on that information (perception). Signals from the eye are first processed in the early visual cortex, a region at the back of the brain that is necessary for sight. They then travel through other parts of the cerebral cortex, enabling recognition of patterns, faces, objects, scenes, and written words. In adults, even if their sight is still present, injury or removal of even a small area of the brain's vision processing centers can lead to dramatic, permanent loss of perception, making them unable to recognize faces, locations, or to read, for example. But in children, who are still developing, this part of the brain appears able to rewire itself, a process known as plasticity.

While brain surgery can halt epilepsy seizures, it carries significant risks, including an impairment in visual perception. According to an article published in the Journal of Neuroscience (4 Jun 2019), it was shown that in children, the brain can compensate for missing regions of the visual cortex after epilepsy surgery to retain visual perception. The study also showed that after brain surgery, children can keep full visual perception. However, this new study suggests that the lasting effects on visual perception can be minimal, even among children who lost tissue in the brain's visual centers.

The study recruited 10 children who had undergone surgery for severe epilepsy - caused in most cases by an injury such as stroke in infancy, or by a tumor - and 10 matched healthy children as a control group. Of the children with surgery, three had lost parts of the visual cortex on the right side, three on the left side, and the remaining four had lost other parts of the brain not involved in perception, serving as a second kind of control group. Of the six children who had areas of the visual cortex removed, four had permanent reductions in peripheral vision on one side due to loss of the early visual cortex. The epilepsy was resolved or significantly improved in all children after surgery. The children ranged in age from 6 to 17 years at the time of surgery, and most joined the study a few years later.

The authors tested the children's perception abilities, including facial recognition, the ability to classify objects, reading, and pattern recognition. Despite in some cases completely lacking one side of the visual cortex, nearly all the children were able to successfully complete these behavioral tasks, falling within the normal range even for complex perception and memory activities. To better understand how the children were able to compensate after surgery, the team imaged the children's brains with functional magnetic resonance imaging (fMRI) while the children engaged in perceptual tasks. fMRI allows researchers to visualize which regions of the brain are activated during specific activities. The team was able to map specific locations in the brain required for individual perception tasks both in the control children and in the children who had undergone surgery. These regions included the early visual cortex, the fusiform face area (required for facial recognition), the parahippocampal place area (required for processing scenes and locations), the lateral occipital complex (required for object recognition), and the visual word form area (necessary for reading). Most of the regions for visual perception exist bilaterally - that is, both sides of the brain are involved in these tasks. The exceptions, however, are for facial recognition (fusiform face area), which tends to be more dominant in the right hemisphere, and for the visual word form area.

Interestingly, for one study participant whose surgery had removed most of the visual cortex in the left hemisphere, this reading-specific visual word form area region remapped to the right hemisphere, sharing space next to the facial recognition region on that side. But even for those participants who did not show such clear remapping, the remaining hemisphere was still able to compensate for missing regions in a way not usually seen in adults.

According to the authors, while it isn't clear exactly when this compensation took place, they believe that it may begin well before surgery, in response to the damage that caused the epilepsy in the first place. The authors added that it is possible that early surgical treatment for children with epilepsy might be what allows this remapping, although more research is needed to understand what drives this type of brain plasticity.

Irregular Sleep Patterns Linked to Obesity, Diabetes, High Cholesterol

June 10, 2019

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Metabolism

According to an article published in Diabetes Care (5 June 2019), a study has found that not sticking to a regular bedtime and wakeup schedule -- and getting different amounts of sleep each night -- can put a person at higher risk for obesity, high cholesterol, hypertension, high blood sugar and other metabolic disorders. The study noted that for every hour of variability in time to bed and time asleep, a person may have up to a 27% greater chance of experiencing a metabolic abnormality.

For the study, the authors followed 2,003 men and women, ages 45 to 84, participating in the NHLBI-funded Multi-Ethnic Study of Atherosclerosis (MESA). The participants were studied for a median of six years to determine the associations between sleep regularity and metabolic abnormalities. To ensure objective measurement of sleep duration and quality, participants wore actigraph wrist watches to closely track sleep schedules for seven consecutive days. They also kept a sleep diary and responded to standard questionnaires about sleep habits and other lifestyle and health factors. Participants completed the actigraphy tracking between 2010 and 2013 and were followed until 2016 and 2017.

Results showed that individuals with greater variations in their bedtimes and in the hours they slept, had a higher prevalence of metabolic problems, and these associations persisted after adjusting for average sleep duration. This was also the case when they looked at the participants who developed metabolic disorders during the 6.3 years of follow up. The prospective results also showed that the variations in sleep duration and bedtimes preceded the development of metabolic dysfunction. According to the authors, this provides some evidence supporting a causal link between irregular sleep and metabolic dysfunction. Participants whose sleep duration varied more than one hour were more likely to be African-Americans, work non-day shift schedules, smoke, and have shorter sleep duration. They also had higher depressive symptoms, total caloric intake, and index of sleep apnea. Increasing sleep duration or bedtime variability was strongly associated with multiple metabolic and simultaneous problems such as lower HDL cholesterol and higher waist circumference, blood pressure, total triglycerides, and fasting glucose.

According to the authors, their results suggest that maintaining a regular sleep schedule has beneficial metabolic effects, and that this message may enrich current prevention strategies for metabolic disease that primarily focus on promoting sufficient sleep and other healthy lifestyles.

Alexandre Emile Jean Yersin MD (1863-1943)

June 10, 2019

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History of Medicine

Alexandre Emile Jean Yersin (1863-1943), physician and bacteriologist
Photo credit: By Rvalette; edited by Jaybear - Own work, Public Domain,
https://commons.wikimedia.org/w/index.php?curid=15108752

The causative bacterium of plague was described and cultured by Alexandre Yersin in Hong Kong in 1894, after which transmission of bacteria from rodents by flea bites was discovered by Jean-Paul Simond in 1898. Effective treatment with antiserum was initiated in 1896, but this therapy was supplanted by sulphonamides in the 1930s and by streptomycin starting in 1947. India suffered an estimated 6 million deaths in 1900-1909, and Vietnam, during its war in 1965-1975, accounted for approximately 80% of the world's cases. Since then, African countries have dominated, with >90% of the world's cases in the 1990s and early 21st century. Serological diagnosis with fraction 1 antigen to detect anti-plague antibodies was developed in the 1950s. Vaccine development started in 1897 with killed whole bacterial cells, and this was followed by a live attenuated bacterial vaccine, leading to millions of persons receiving injections, but the benefits of these vaccines remain clouded by controversy. Plasmid-mediated virulence was established in 1981, and this was followed by specific DNA methods that have allowed detection of plague genes in skeletal specimens from European graves of the sixth to 17th centuries.

The modern history of plague began in 1894, when Alexandre Yersin isolated the causative bacterium in culture and identified it under the microscope. This event allowed laboratory confirmation for accurate diagnoses. There followed many advances in treatment and diagnosis, as well as scientific understanding of the disease.

Alexandre Emile Jean Yersin (22 September 1863 - 1 March 1943) was a Swiss and naturalized French physician and bacteriologist. He is remembered as the co-discoverer of the bacillus responsible for the bubonic plague or pest, which was later named in his honor (Yersinia pestis). Yersin also demonstrated for the first time that the same bacillus was present in the rodent as well as in the human disease, thus underlining the possible means of transmission. Yersin was born in 1863 in Aubonne, Canton of Vaud, Switzerland, to a family originally from France. From 1883-1884, Yersin studied medicine at Lausanne, Switzerland; and then at Marburg, Germany and Paris (1884-1886). In 1886, he entered Louis Pasteur's research laboratory at the Ecole Normale Sup?rieure, by invitation of Emile Roux, and participated in the development of the anti-rabies serum. In 1888 he received his doctorate with a dissertation titled Etude sur le Developpement du Tubercule Experimental and spent two months with Robert Koch in Germany. He joined the recently created Pasteur Institute in 1889 as Roux's collaborator and discovered with him the diphtheric toxin (produced by the Corynebacterium diphtheriae bacillus).

To practice medicine in France, Yersin applied for and obtained French nationality in 1888. Soon afterwards (1890), he left for French Indochina in Southeast Asia as a physician for the Messageries Maritimes company, on the Saigon-Manila line and then on the Saigon-Haiphong line. He participated in one of the Auguste Pavie missions. In 1894 Yersin was sent by request of the French government and the Pasteur Institute to Hong Kong, to investigate the Manchurian pneumonic plague epidemic. There, in a small hut (according to Plague by Wendy Orent) since he was denied access to English hospitals at his arrival, he made his greatest discovery: that of the pathogen which causes the disease. The plague bacillus develops better at lower temperatures, so Yersin's less well-equipped lab turned out to be an advantage, over other researchers who used incubators. Yersin was also able to demonstrate for the first time that the same bacillus was present in the rodent as well as in the human disease, thus underlining the possible means of transmission. This important discovery was communicated to the French Academy of Sciences in the same year, by his colleague Emile Duclaux, in a classic paper titled "La peste bubonique a Hong-Kong".

From 1895 to 1897, Yersin further pursued his studies on the bubonic plague. In 1895 he returned to the Institute Pasteur in Paris and with Emile Roux, Albert Calmette and Am?d?e Borrel, prepared the first anti-plague serum. In the same year, he returned to Indochina, where he installed a small laboratory at Nha Trang to manufacture the serum (in 1905 this laboratory became a branch of the Pasteur Institute). Yersin tried the serum received from Paris in Canton and Amoy, in 1896, and in Bombay, India, in 1897, with disappointing results. Having decided to stay in his country of adoption, he participated actively in the creation of the Medical School of Ha Noi in 1902, and was its first director, until 1904. Yersin tried his hand at agriculture and was a pioneer in the cultivation of rubber trees (Hevea brasiliensis) imported from Brazil into Indochina. For this purpose, he obtained in 1897 a concession from the government to establish an agricultural station at Suoi Dau. He opened a new station at Hon Ba in 1915, where he tried to acclimatize the quinine tree (Cinchona ledgeriana), which was imported from the Andes in South America by the Spaniards, and which produced the first known effective remedy for preventing and treating malaria (a disease which prevails in Southeast Asia to this day).

Alexandre Yersin is well remembered in Vietnam, where he was affectionately called Ong Nnm (Mr. Nam/Fifth) by the people. On 8 January 1902, Yersin was accredited to be the first Headmaster of Hanoi Medical University by the Governor-General of French Indochina, Paul Doumer. Following the country's independence, streets named in his honor kept their designation and his tomb in Suoi Dau was graced by a pagoda where rites are performed in his worship. His house in Nha Trang is now the Yersin Museum, and the epitaph on his tombstone describes him as a "Benefactor and humanist, venerated by the Vietnamese people". In Ha Noi, a French lycee has his name. A private university founded in 2004 in Da Lat was named "Yersin University" in his honor. In 1934 he was nominated honorary director of Pasteur Institute and a member of its Board of Administration. He died during World War II at his home in Nha Trang, in 1943.

Dr. Yersin was credited with finding the site for the town of Dalat (300 km northeast of Saigon) in 1893. Because of the high altitude and European-like climate, Dalat soon became an R&R spot for French officers. There was a high school named after him which was built in the 1920s, the Lycee Yersin, aka Grand Lycee (grade 6 to 12), the Petit Lycee (elementary to grade 5) and a university named for him which was built in the 2000s. While in Hong Kong, Yersin was helped in his research by an Italian priest of the PIME order, Bernardo Vigano (1837-1901), who provided cadavers and assisted him with his quest to find a remedy for the plague.

PUBLIC HEALTH - Climate Change & Pandemics

June 10, 2019

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Quiz

Seven of these indicators would be expected to increase in a warming world and observations show that they are, in fact, increasing. Three would be expected to decrease and they are, in fact, decreasing
Graphic credit: by US National Oceanic and Atmospheric Administration: National Climatic Data Center - State of the Climate in 2009: Supplemental and Summary Materials: Report at a Glance: Highlights[1], US National Oceanic and Atmospheric Administration: National Climatic Data Center, (Please provide a date or year), page 2., Public Domain,
https://commons.wikimedia.org/w/index.php?curid=22913531

A pandemic killing tens of millions of people is a real possibility - and we are not prepared for it. A century ago, a pandemic killed more than 50 million people.

The world is at risk of another 1) ___ of similar scale. What single event killed more Americans than any other in our history? The attacks of 9/11? The epic conflicts of World War I or World War II? None of the above. The catastrophe that killed more 2) ___ than all of the events above combined: the Spanish flu epidemic of 1918, which took as many as 675,000 lives in this country and more than 50 million worldwide - killing nearly one out of every 20 humans then alive.

One hundred years later, it is the prospect of another such pandemic - not a nuclear 3) ___, or a terrorist attack, or a natural disaster - that poses the greatest risk of a massive casualty event in the United States. The scope of the danger is breathtaking: Bill Gates, citing epidemiologists, has said that there is a “reasonable probability“ of a pandemic that kills more than 30 million people worldwide in the next two decades. A tabletop exercise run at Johns Hopkins Center for Health Security in May simulated a global flu-like outbreak called Clade X and found that 150 million people (including 15 million in the US) would die in the first year alone. In an era with so much progress in science and medicine, how can the United States remain so vulnerable to such a pandemic? With so much money and energy being devoted to combatting large-scale terrorist attacks, nuclear proliferation, and other dangers, why has so much less attention been devoted to a threat that is arguably more likely and potentially deadlier?

We cannot totally eliminate the risk of pandemics in the near term. But a three-pronged agenda focused on mitigating that risk - pushing for better and faster vaccine development and deployment, a stronger emergency response infrastructure, and a more robust global health security system - can make us safer. But most importantly, we need to take the 4) ___ seriously. A catastrophic pandemic is not merely the stuff of dystopian fiction. It is very much a real danger, as real today as it was 100 years ago. America in 2019 is in many respects safer from the pandemic threat than America was in 1918. Advances in science and medicine have given us many tools to combat a pandemic flu that we lacked a century ago. In the event that existing vaccines provide no protection from a particular new flu threat, antiviral medicines would at least pose a partial first line of defense against the epidemic until a 5) ___ could be developed. Antibiotics would also help combat secondary infections, which killed so many in 1918. We have made progress in 100 years. But for every one of these modern miracles that makes us safer, there is some other element of modernity that raises our risk level from what it was a century ago. Global transportation networks can bring a virus from a remote corner of the world to one of its most populous cities in less than 24 hours. The clustering of more people into 6) ___ - especially supercities in Asia - creates fertile grounds for such diseases to spread quickly. The incursion of humans into wildlife habitats is increasing the crossover of zoonotic diseases (like Ebola) from animals into people. Climate change is expanding the reach of disease-bearing vectors like mosquitoes into new regions and putting new populations at risk. The possibility that an epidemic could take a huge number of lives here and around the world should be no surprise, given our collective experience with the HIV/AIDS epidemic, which has killed more than 35 million worldwide. More recently, the West African Ebola epidemic of 2014-'15, killed more than 11,000 people there and spread panic worldwide before it was contained.

The past two decades have seen a roll call of near-miss catastrophes. The SARS outbreak of 2002. The H1N1 flu of 2009. The MERS outbreak of 2012. And, of course, the Ebola epidemic of 2014, which at one point was forecast to take 1 million lives. They all were horrible, but each could have been significantly worse. H1N1 offers a telling story. At a time when the world worried about a pandemic flu coming from Asia, H1N1 exploded from Mexico and California across the US. Once it was identified as a pandemic risk, an all-out effort to create a vaccine was launched - but the vaccine wasn't made widely available to the public until after the epidemic's peak. Even then, manufacturers were able to produce only a limited supply. Government officials gave conflicting guidance about the danger and the safety of routine actions (like keeping schools opened or air travel with infected people). In the end, about 60 million Americans contracted H1N1 that year ? which, by pure luck, turned out not to be a particularly 7)___ strain. Had it been even one-tenth as deadly as the Spanish flu (which was estimated to have killed about 10 to 20% of those it infected), even our modern medicine could not have prevented hundreds of thousands of Americans from dying in a relatively short period of time, in an event that would be more searing in contemporary consciousness than 9/11.

New political and social trends further increase our risk level. Americans need to be better informed about the seriousness of allowing all children to have their vaccinations. There is an unfortunate rising tide of anti-vaccine sentiment in the US and Europe, which is raising the risk of a resurgence of once-vanquished infectious diseases (like measles), and increasing the likelihood of massive vaccine resistance in the event of an epidemic. The ability of social media to rapidly spread false information - painfully illustrated in the 2016 campaign - is another source of danger: Would the directives of public health officials be followed in a crisis? Would they be undermined by misinformation spread by misguided provocateurs or a hostile foreign power? And then there is the risk factor of isolationism and xenophobia. While responsible officials in the Trump administration have responded to two Ebola outbreaks in the Democratic Republic of Congo this year (including one that is far from under control), in a more visible crisis, Trump's isolationist instincts might assert themselves. In 2014, such views led him to tweet that President Barack Obama should not have evacuated American Ebola fighters who contracted the disease from West Africa, and instead, should have left them to “suffer the consequences“ of their condition. Xenophobic views played a critical role in the tardy response to Zika in 2015-16. Congress delayed acting on a funding package because Zika was perceived to be a “foreigner's disease.“ “Zika isn't a public health problem, it's an immigration problem - just keep the foreigners out,“ In order to prevent a pandemic, countries around the globe need to focus on controlling disease within and without their respective borders. Working together should be the mantra for preventing a world-wide pandemic.

Regarding the Zika virus, there was no evidence that it was 8) ___ - as opposed to Americans coming home from vacations - that were bringing the disease to our shores. The anti-Zika funds stalled in Congress, and we eventually saw transmission of the disease in Florida, and the first-ever Centers for Disease Control and Prevention (CDC) warning against travel to parts of the continental US. More generally, a turn inward risks undercutting our best defense against epidemics: working with other countries to fight them overseas. The administration has proposed cutting international programs at the National Institutes of Health and CDC to fund his border wall. That may have political appeal to his base, but the reality is that there is no wall high enough to keep infectious diseases out of our country. (To date, Congress has rejected such proposals from the president, and boosted funding for the two agencies.) Reducing our risk from these dangers is a vast undertaking, and runs the gamut from better surveillance systems to massive medical research projects to all forms of global investments. But three items should top our agenda:

1) Improve vaccine development and deployment

While the ultimate goal of a “universal flu vaccine“ is still far in the future, better vaccines that cover a wider array of flu strains are coming sooner. In 2017, a global public-private partnership named the Coalition for Epidemic Preparedness Innovations (CEPI) was formed to accelerate vaccine development for epidemic infectious diseases threats. Though CEPI was launched with generous support from donors like the Gates Foundation and the Wellcome Trust, it can fund work on only a handful of the highest-priority vaccines. Even for the world's best scientists, predicting which diseases should be prioritized is hard. Earlier in 2017, a conference in the runup to the formation of CEPI, was held, where scientists discussed a “top 10“ list. Just a few months later, Zika - not even on the list - was a huge threat. Earlier in 2019, a new flu appeared in China. We're still not sure about the severity of it. Moreover, inventing vaccines doesn't save lives; vaccinating people does. Even if scientists discover promising vaccines for infectious diseases threats, the world predominantly relies on private vaccine makers to bring those vaccines to market, which is not always a certainty. (Large vaccine makers felt burned spending millions on developing an Ebola vaccine in 2014 that will never yield profits.) Vaccines also face complex regulatory challenges - the Ebola vaccine tested in 2014 and being used now in the Democratic Republic of Congo isn't licensed - and a hazy global policy framework on issues like intellectual property from clinical tests. What's more, while the US has a legal process to govern liability and compensation for anyone injured if a new vaccine is used on an emergency basis (called the PREP Act), most countries don't, creating a substantial risk that a vaccine could be made to combat a crisis - and be left sitting in warehouses while lawyers and policymakers hash out the details.

The world has a hugely successful system, run by the amazingly efficient alliance known as Gavi, for funding and distributing well-established, proven vaccines in developing countries. Gavi - a public-private partnership of developed and developing nations, the World Health Organization (WHO), the World Bank, the Gates Foundation, and other civil society groups - has grown in scope and scale since its launch in 2000. It has now taken on deployment of the new Ebola vaccine as a project, and it could be a vehicle for tackling many of the complex issues of funding and implementing an emergency epidemic response vaccine plan, but that would require additional funding sources and support to ensure that Gavi is not distracted from its core work of vaccinating millions against existing disease threats.

2) Strengthen US epidemic preparation and response

A global review known as the “Joint External Evaluation“ gave the US some of the strongest marks among the world's countries for being ready to cope with an epidemic. But that should provide only small comfort. Not one city in America has existing capacity (i.e., treatment units within a hospital supported by trained staff and equipment) to treat more than a handful of dangerous infectious diseases patients at one time. During the Ebola epidemic, the US government distributed patients carefully so that even our very best infectious diseases hospitals - facilities in Nebraska, at NIH, and at Emory - never treated more than two patients at a time. An outbreak of even just a few dozen cases of a deadly, highly infectious disease - let alone a few hundred - would overwhelm any city in our country. In such a scenario, death would beget death, as patients carrying the virus would stream into hospitals and infect others who did not yet have the disease. Health care workers would be put at risk, and as word spread, people who were not infected but who had other ailments would stay away from hospitals. Death rates from heart attacks, strokes, childbirth, and other urgent care situations would spike. After the Ebola epidemic of 2014, Congress funded a system of 10 regional “special pathogen“ infectious diseases treatment centers in the US, a vast improvement from the three we had before the epidemic. Even so, these centers only have a total of approximately 100 equipped treatment beds - isolated hospital beds with necessary equipment and trained staff - and as the fears of 2014 fade in memory and our guard drops, the response time at these facilities to go from “standby“ to “ready“ is rising. We need to step up our investment in facilities, training, and equipment for our domestic epidemic response - and do so now, not when a crisis comes. And we need to give a president some basic tools to cope with such a threat: a robust Public Health Emergency Response Fund to fund the early stages of a response (the perennially underfunded reserve currently holds just 2 percent of what the US spent on the Ebola response), and the same kind of disaster assistance authority under the Stafford Act for epidemics that the president now has for earthquakes or hurricanes. We need to create a new group of federal epidemic responders, which could be called the Public Health Emergency Management Agency (PhEMA); barring that, we should create a specialized unit in the Federal Emergency Management Agency that is trained and equipped for the job. But most of all, we need to stick with (and indeed, even increase) our commitment to the Global Health Security Agenda launched by President Obama, which helps other countries build up their capacities to detect and respond to outbreaks. Spending on such “foreign aid“ will never be popular. But we should think of infectious disease threats the way we think of terrorism: The best way to make America safer is to make the 9) ___ safer from this danger.

3) Bolster global response capabilities

It would shock most people to know that there is no elite squadron of fully equipped global epidemic responders ready to be deployed when the alarm sounds. During the Ebola epidemic, it was said that the thing that should scare people is not that the black helicopters will be landing in their backyards any minute now - it's that there are no black helicopters coming, even if you need them. Our current global response capacity relies on the WHO to declare that an epidemic is underway, and provide general coordination for a response. Most of the hardest work - actually treating sick patients, and engaging with locals on how to deal with the threat - is performed by a number of courageous NGOs such as Doctors Without Borders, the International Rescue Committee, and Partners in Health. The WHO was roundly criticized for its handling of the 2014 Ebola epidemic, and new leadership was installed in 2017. Under Dr. Tedros Adhanom Ghebreyesus, the WHO's new director general, the organization has improved its work on epidemics and is acting in a more transparent fashion. But even so, the WHO - which was created initially to spotlight violations of international health regulations - has not been, and seems unlikely to become, an organization with the kind of personnel, equipment, or authority to power a full-scale pandemic response.

NIH Launches Ebola Vaccine Trials In Liberia

Moreover, as we saw, in the recent WHO-led Ebola response in the Democratic Republic of Congo - where the response fell behind the disease, and the risk of spread to adjacent countries was rising - when epidemic responders encounter local violence, civil discord, or security threats, they have no protection and must sometimes cease operations. Officials complain that the violent, chaotic conditions in the Eastern Congo are a “worst case“ for an Ebola outbreak, but in a truly ghastly epidemic, instability and regional violence is likely to become the rule, not the exception. Some world leaders have backed a plan first proposed by then-German Foreign Minister Frank-Walter Steinmeier to create a multinational white helmet brigade that could provide security and logistical dimensions to an epidemic response. In 2014, the UN established a temporary unit that helped do similar work in West Africa called UNMEER, or the UN Mission for Ebola Emergency Response. That effort got mixed reviews for its uneven performance and rapidly rotating personnel in West Africa, but perhaps the UN could take another run at creating such a response unit. But the bottom line is this: If science fiction became reality, and the world was threatened by interstellar invaders putting tens of millions of lives at risk, it's hard to believe we would face that danger “armed“ only with an international regulatory organization and a cluster of NGOs. And yet that is precisely what we will be relying on when a major epidemic comes our way. In the end, the question we will face is not if a massive global pandemic will hit, but when. Pandemics have recurred throughout history with devastating consequences, from the bubonic plague in the Middle Ages to the Spanish flu a century ago to HIV/AIDS in our own lifetimes. The more we do now to accelerate vaccine research and deployment, bolster the home front for the coming threat, and invest in a global 10)___ security agenda and response capacities, the better we will fare when that day comes. Sources: The Rockefeller Foundation, Ron Klain; Wikipedia

ANSWERS: 1) pandemic; 2) Americans; 3) war; 4) risk; 5) vaccines; 6) cities; 7) lethal; 8) foreigners; 9) world; 10) health

Partnering with CROs Outside the US

June 10, 2019

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What's New

Target Health Inc., a New York City-based, technology driven eCRO, was founded in 1993 by our CEO, Joyce Hays, who also put us on the right track to create our own brand of software. Since then, our focus has been getting products approved in the United States for both our domestic and international clients.

Clinical Research is now a global process spanning all continents. In order to offer sophisticated and experienced approaches to drug, diagnostic and device development for the global clinical research markets, Target Health has established partnerships with some of the best small to mid-size CROs from all corners of the world. Of course, we also work directly with big pharma. Our collaborations include local regulatory affairs and clinical monitoring by our partners. For clinical trials, our partners use Target e*CRF® as the EDC system, and Target Document® as the eTMF.

Here are some examples: Last year, we managed an NDA review which resulted in the approval of a rare tropical disease. The project came from a partner in Europe who asked us to interact with the FDA during the review process. A CRO in Israel and Korea have in-licensed our software, including the direct data capture (DDC) eSource solution. A CRO in Argentina is using our software for a tropical disease program, and several years ago, we collaborated with a CRO in Israel resulting in the approval of a drug to treat a rare disease. While Target Health did all FDA interactions, data management, biostatistical analyses and medical writing, the CRO managed all international operations, and used all of our software systems. This was a win-win for all.

Here are some examples: Last year, we managed an NDA review which resulted in the approval of a rare tropical disease. The project came from a partner in Europe who asked us to interact with the FDA during the review process. A CRO in Israel and Korea have in-licensed our software, including the direct data capture (DDC) eSource solution. A CRO in Argentina is using our software for a tropical disease program, and several years ago, we collaborated with a CRO in Israel resulting in the approval of a drug to treat a rare disease. While Target Health did all FDA interactions, data management, biostatistical analyses and medical writing, the CRO managed all international operations, and used all of our software systems. This was a win-win for all.

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. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.

Joyce Hays, Founder and Editor in Chief of On Target

Dr. Jules T. Mitchel, Editor

Citrus Celebration

Colorful delicious citrus fruit is still in season and on hand for all Celebrations. A favorite for all fruit desserts is the Cara Cara orange, Mandarin and Clementines. When peak fruit is selected for flavor as well as color, you have a real treat. We have been serving these fruit platters to guests for over a month now. ©Joyce Hays, Target Health Inc.
At this dinner, we offered for dessert both fresh fruit and chocolate cake with coffee. Believe it or not, our guests chose only the fruit, although, they were offered both. ©Joyce Hays, Target Health Inc.
When we offer our citrus fruit platter with watermelon and dates, garnished with pomegranate arils and chopped pistachios, the colors are so gorgeous, the fruit so tempting, no one can resist. ©Joyce Hays, Target Health Inc.
Fruit and flowers, irresistible ! ©Joyce Hays, Target Health Inc.
At a recent dinner, we served red cabbage salad with goat cheese and Cara Cara oranges. ©Joyce Hays, Target Health Inc.
Citrus platter ingredients: gather as many different flavors and colors of citrus fruit as you have available to you. Include a lovely ripe watermelon, some dates, pomegranate arils and toasted then chopped pistachios. That's it; that's all you need. ©Joyce Hays, Target Health Inc.
Cut the watermelon and cut bite-size pieces. ©Joyce Hays, Target Health Inc.
With a sharp knife, peel all citrus fruit. Then cut circles, starting with horizontal slicing, from the bottom to the top. (not vertical slices). ©Joyce Hays, Target Health Inc.
After all fruit is cut and/or sliced, have fun designing your fruit platter. The different shapes and colors are what makes this platter so inviting. ©Joyce Hays, Target Health Inc.
Cut each date in half. ©Joyce Hays, Target Health Inc.
Continuing to arrange - like painting a still life. ©Joyce Hays, Target Health Inc.
Just about finished. Next, the chopped pistachios. ©Joyce Hays, Target Health Inc.
Sitting on kitchen table, ready to be served in dining room. ©Joyce Hays, Target Health Inc.
We like to have wine and nibbles near our Koi aquarium. We served beautiful veggies with a cheese dip. Try the idea of hollowing out a red cabbage (save the leaves for another recipe like salad or soup) and use it as a serving bowl for the dip. Adds another bit of color to the nibbles. ©Joyce Hays, Target Health Inc.
This almond liqueur went well with the delicious Citrus Celebration. ©Joyce Hays

From Our Table to Yours

Have a Great Week Everyone!

Bon Appetit!

Gene Therapy Treatment for Spinal Muscular Atrophy

June 3, 2019

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Regulatory

Spinal muscular atrophy (SMA) is a rare genetic disease caused by a mutation in the survival motor neuron 1 (SMN1) gene. The gene encodes the survival motor neuron (SMN) protein - a protein found throughout the body, which is critical for the maintenance and function of specialized nerve cells, called motor neurons. Motor neurons in the brain and spinal cord control muscle movement throughout the body. If there is not enough functional SMN protein, then the motor neurons die, leading to debilitating and often fatal muscle weakness. SMA caused by mutations in the SMN1 gene is generally classified into several subtypes, based on the age of onset and severity; infantile-onset SMA is the most severe and most common subtype. Children with this condition have problems holding their head up, swallowing and breathing. These symptoms may be present at birth or may present by the age of 6 months.

The FDA approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with SMA, the most severe form of SMA and a leading genetic cause of infant mortality.

Zolgensma is indicated for the treatment of children less than two years of age with SMA. The product is an adeno-associated virus vector-based gene therapy that targets the cause of SMA. The vector delivers a fully functional copy of human SMN gene into the target motor neuron cells. A one-time intravenous administration of Zolgensma results in expression of the SMN protein in a child's motor neurons, which improves muscle movement and function, and survival of a child with SMA. Dosing is determined based on the weight of the patient.

The safety and effectiveness of Zolgensma is based on an ongoing clinical trial and a completed clinical trial involving a total of 36 pediatric patients with infantile-onset SMA between the ages of approximately 2 weeks and 8 months at study entry. The primary evidence of effectiveness is based on results from the 21 patients treated with Zolgensma in the ongoing clinical trial. In this trial, there are 19 remaining patients, who range in age from 9.4 to 18.5 months; 13 of these 19 patients are at least 14 months of age. Compared to the natural history of patients with infantile-onset SMA, patients treated with Zolgensma also demonstrated significant improvement in their ability to reach developmental motor milestones (e.g., head control and the ability to sit without support). The most common side effects of Zolgensma are elevated liver enzymes and vomiting. Zolgensma has a boxed warning that acute serious liver injury can occur. Patients with preexisting liver impairment may be at higher risk of experiencing serious liver injury. Clinical examination and laboratory tests to assess liver function should be completed prior to treatment with Zolgensma, and patients' liver function should be monitored for at least three months after Zolgensma administration. Certain vaccines are contraindicated for patients on a substantially immunosuppressive steroid dose. Therefore, caregivers should consult with their healthcare professional to determine if adjustments to the patient's vaccination schedule are necessary to accommodate concomitant corticosteroid administration.

The FDA granted this application Fast Track, Breakthrough Therapy, and Priority Review designations. Zolgensma also received Orphan Drug designation, which provides incentives to encourage the development of drugs for rare diseases. The FDA also awarded the manufacturer a rare pediatric disease priority review voucher, under a program intended to encourage the development of new drugs and biological products for the prevention and treatment of certain rare pediatric diseases.

The FDA granted the approval of Zolgensma to AveXis Inc.

Microbiome Composition Linked to Preterm Birth Risk Among African Americans

June 3, 2019

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Neonatology

Microscopic study of the healthy human body has demonstrated that microbial cells outnumber human cells by about ten to one. Prior to the start of the NIH Common Fund's Human Microbiome Project (HMP), this abundant community of human-associated microbes remained largely unstudied, leaving their influence upon human development, physiology, immunity, and nutrition almost entirely unknown. The HMP was established with the mission of generating research resources, which were rapidly and broadly shared, enabling comprehensive characterization of the human microbiota and their metabolic capabilities and analysis of their role in human health and disease. The information generated by HMP is now available worldwide for use by investigators and others in efforts to understand and improve human health.

According to an article published in Nature Medicine (29 May 2019), a research project funded by the National Institutes of Health has identified differences in the vaginal bacteria that may raise the risk of preterm birth among pregnant African-American women. The findings could be a first step toward the development of a screen for the early identification of preterm birth risk in this population. The study analyzed a subset of more than 1,500 women participating in the HMP. They obtained samples of vaginal bacteria from 45 pregnant women who ultimately delivered preterm and compared them to similar samples from 90 pregnant women who delivered at term. Nearly 80% of the women in this subset, both those who delivered preterm and at term, were African-American, and the remainder were white, Hispanic, and American Indian/Alaska native.

Results showed that the women who delivered preterm had a much more diverse microbiome in early pregnancy, compared to their peers. The preterm group had lower levels of the bacterium Lactobacillus crispatus, higher levels of BVAB1, a bacterium associated with a condition called bacterial vaginosis, and 12 other bacterial groups. The authors linked this combination of bacterial species to the presence of immune system factors that promote inflammation. Previous studies have found higher levels of inflammation-promoting factors in women who deliver preterm. The authors noted that larger studies are necessary to confirm their findings.

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