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March 20, 2017What's New
Target Health Inc. is pleased to announce that Dr. Jules Mitchel will be presenting at CBI's 4th Annual Bootcamp on eSource Data in Clinical Investigations. The conference aims to initiate meaningful dialogues, through collaborative sessions and investigative case studies, around early successes, challenges and failures, so that one can build an eSource adoption business case for senior leadership addressing balance of risk and cost.
Dr. Mitchel's presentation is entitled: The Future is Now: How to Obtain Stakeholder Buy-in and Initiate the Migration to eSource. In this case study, you will learn how eSource reduced monitoring and increased overall data quality, as well as how to convince stakeholders to invest in eSource. You will also learn of the current challenges of interoperability between EHR and eSource and what the long-term strategy looks like in moving away from EDC as we know it today.
Please Mention Promo Code: NCE547 for a $500 discount when you register at the conference www.cbinet.com/esource.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor
March 20, 2017History of Medicine
Kfar Shaul Mental Health Center, established in 1951, is an Israeli public psychiatric hospital located between Givat Shaul and Har Nof, Jerusalem. It is affiliated with the Hadassah Medical Center and the Hebrew University of Jerusalem. The hospital is Jerusalem's designated psychiatric hospital for tourists who display mental health disturbances, and is widely known for its research on Jerusalem Syndrome.
The Givat Shaul mental health center opened in 1951, utilizing the houses and school building of Deir Yassin, which had been left untouched. It was originally a therapeutic community of 300 patients who spent most of the day working outdoors. It was called the Kfar Shaul Government Work Village for Mental Patients. In its early years, the majority of the patients were Holocaust survivors.
The hospital is equipped with Snoezelen rooms, a Dutch therapy technique which uses controlled stimulation of the five senses to benefit the mentally and physically disabled. The hospital is known in particular for its association with Jerusalem Syndrome, a condition in which the sufferer is gripped by religious delusions. The hospital sees some 50 patients a year who are diagnosed with the condition Israel psychologist Gregory Katz has said many of the patients are Pentecostals from rural parts of the United States and Scandinavia. The syndrome was first diagnosed in 1993 by Yair Bar-El, a former director of the hospital. In 2000, archaeologists unearthed the remains of a winepress dated to the Byzantine or Roman era on the grounds of the hospital.
Shaare Zedek was the first large hospital to be located in the Western portion of Jerusalem and is today the city's fastest growing hospital and the only major medical facility in the city's center. After the Ottoman Turks gave permission in the 1890s, and with funding from European donors, the hospital was built on Jaffa Road, two miles (3 km) outside the Old City. Its opening ceremony took place on January 27, 1902. Dr. Moshe Wallach was the director from then until 1947. Schwester Selma lived in the hospital and cared for abandoned children. The building in Bayit Vegan was inaugurated in 1980. In December 2012, Shaare Zedek assumed operational control over Bikur Cholim Hospital and merged many of its activities. The hospital treats over 600,000 patients per year in more than 30 inpatient departments and over 70 outpatient units and maintains a very active academic service as a leading research and teaching institution. Shaare Zedek is classified as a public/private hospital, serving as a non-profit institution and dependent on donor support for capital development, while committed to offering advanced medical care for the wider Jerusalem-area community.
March 20, 2017Regulatory
The FDA is committed to helping deliver innovative, safe, and effective treatments and cures to the patients who need them as quickly as possible. To achieve this goal, FDA has implemented a variety of expedited review programs and are working to help shorten the development time before a product is even submitted for FDA review.
As a result of these efforts, in 2014 alone, FDA approved 51 new molecular entities and biological products (41 by the Center for Drug Evaluation and Research and 10 by the Center for Biological Evaluation and Research). These approvals included major therapeutic advances in the treatment of cancer, hepatitis C and type-2 diabetes. They also included vaccines for meningococcus type B, and more new orphan drugs for rare diseases than any previous year.
FDA has also made strides with medical devices. As a result of activities coordinated by CDRH Innovation, and programmatic improvements and innovative use of our existing approval and clearance pathways, many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Products recently approved or cleared by FDA include the BrainPort V100, a first-of-its-kind wearable device that can help orient profoundly blind individuals to their physical surroundings; Watchman LAA Closure Technology, a permanently implanted device that prevents certain clots from entering the bloodstream and potentially causing a stroke; and the Maestro Rechargeable System to treat obesity in certain adult patients (it targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness).
March 20, 2017Quiz
A bizarre mental illness that affects people visiting Israel is called Jerusalem Syndrome.
There are a lot of events, that can make a visitor feel dazed and confused, when traveling--delayed flights, missing luggage, clumps of tasteless airline food. But for some people who travel can actually induce a rare psychosis--especially if their destination is 1) ___. Tourists afflicted with the condition called Jerusalem Syndrome have been found wandering in the Judean desert wrapped in hotel bed sheets or camped in front of the Church of the Holy Sepulcher, convinced they will soon be birthing the infant Jesus.
Jerusalem Syndrome has been described by foreign visitors over the last few hundred years. Because he was the first to promote treatment and research for this disease, Dr. Bar-El who works at Kfar Shaul Hospital in Jerusalem is considered the father of Jerusalem 2) ___. Bar-El says that there are three categories of tourists who get Jerusalem fever. The first is individual visitors to Israel, who were already mentally ill in their countries of origin. They come to Jerusalem with psychotic ideas that they feel they must act upon in the Holy 3) ___. The second group--the largest one - consists of pilgrims who arrive with deep religious convictions. In some cases, they belong to fringe groups rather than regular churches. They believe they must do specific things to bring about major events like the coming of the Messiah, the appearance of the anti-Christ, the war of Armageddon, or the resurrection of Jesus Christ. The third group is the REAL Jerusalem Syndrome. It affects completely sane tourists without any psychiatric or drug abuse history. They arrive with normal tour groups and suddenly they develop what Bar-El called a specific imperative psychotic reaction. In all cases, the same clinical picture emerges. It begins with generalized 4) ___ and nervousness and then the tourist feels an imperative need to visit the holy places. First, he/she undertakes a series of purification rituals like shaving all body hair, cutting nails and washing over and over before donning white clothes. Most often, such a tourist, removes the white sheets from the hotel room. Then (s)he begins to cry or to sing Biblical or religious songs in a very loud voice. The next step is an actual visit to the holy places, most often from the life of Jesus. The afflicted tourist begins to deliver a sermon--which is frequently a confused oration, exhorting humanity to change their behavior by becoming calmer, purer, and less sophisticated or worldly.
Dr. Bar-El, said that from a 5) ___ point of view, the most interesting aspect is that in addition to this curious psychotic reaction, the patient doesn't see strange things or hear voices, and recalls everything that happens. They know who they are; they don't lose their own identity, and the illness passes completely in five to seven days. Sometimes, the afflicted visitor is on a package tour of the Mediterranean which includes Greece, Egypt and Israel. They may be completely sane in Greece, develop Jerusalem Syndrome in Israel, it passes in five days, and then they continues on with the group to Egypt. From a religious point of view, the Syndrome seems to favor Protestants, who account for 97% of all cases. Their current religious practices aren't very important; the essential element seems to be an ultra-orthodox upbringing where the 6) ___ was the book of choice for family reading and problem solving. Several theologians who are fascinated by Jerusalem Syndrome speculate that Catholics have intermediaries like the Virgin Mary and saints. They also have other geographical locales that are important to them, like the Vatican, which is presided over by the 7) ___. But for Protestants, the only personification in the Bible is Jesus Christ, and the Holy Land is the only place where they can go to follow his life. Hence, they are very focused on Jesus and this sets the stage for the advent of the strange, temporary Holy Land aberration. Although the whole problem of Jerusalem Syndrome may seem like a benign curiosity, it is taken very seriously in Israel where everyone involved in security, tourism, or health and welfare is on the lookout for afflicted visitors. In an average year, about 40 tourists require hospitalization for psychiatric illness. Most are from the first two groups, who had severe problems before they arrived in Israel. A few--perhaps 3 or 4--develop true Jerusalem Syndrome.
Dr. Bar-El said that a woman was picked up by the police for kicking and hitting people at the Church of the Holy Sepulcher, proclaiming, I am the Prophetess of the Olive Tree, and I am very powerful, and I will announce the coming of Christ. She was in a very anxious state, and she insisted she had to remain outdoors, under the influence of the sun and the moon so that her branches could grow green, which was a sign of the immediate return of Jesus. If she was moved inside, under a roof, her branches would grow black, and that would be a sign of the anti-Christ. Besides these claims and her aggressive behavior, everything else about the Olive Tree Prophetess was completely normal. Another seemingly normal man was a teacher from Denmark. Apparently, every year he comes to Jerusalem because only there can he dialogue with the Virgin Mary. Lourdes and other miraculous sites have not had the same effect on him. Bar-El talked about a memorable case which actually led to one of the first instances of collaboration between Palestinian and Israeli police. The Palestinians found a man without clothes, money or ID, and, after interrogation, they figured out he wasn't a security risk. They had no idea what to do with him, so they contacted an Israeli officer. The Israeli asked only one question: Is the guy really completely nude? No, answered the Palestinian, he is wearing an animal skin. Oh, said the Israeli, you've got another John the Baptist. It was the sixth John the Baptist the Israelis had run into. As in the Bible, John the Baptist conducted days of purification between Jerusalem and Galilee before ending up at the Jordan River to baptize Jesus and/or the first Christians. Part of the trek was through 8) ___ territory. John the Baptist heads the Jerusalem Syndrome list for Christian men. Christian women prefer the Virgin Mary. For Jews of both genders, the identification is generally with the Messiah.
At one point, Dr. Bar-El decided to perform a classical experiment. He put two would-be Messiahs in a room together to see if one would prevail. The experiment was a dismal failure because after the meeting each said, I am the real Messiah. He's an impostor. Dr. Gregory Katz, a Russian psychiatrist, works in the units where Jerusalem Syndrome patients are brought and treated. According to Dr. Katz, who works with Jerusalem Syndrome patients, they are basically unremarkable. Their treatment can include anything from melatonin for jet-lag to minor tranquilizers to anti-psychotic drugs. Dr. Katz says that his Jerusalem hospital is equipped to treat tourists in many different languages, although no one in the unit has mastered Norwegian. He explained that the age of the afflicted, ranges from l8 to 70, and the mean age is 35. Most of the patients have higher education and not all of them are connected to religious institutions, although many are. A very timely medical health issue is that Jerusalem Syndrome poses an economic problem for Israel. Some people who fall ill, come from countries where medical insurance is provided for all citizens and they are covered for their treatment. However, tourists from the U.S.A., often don't have any 9) ___ coverage. The Israeli government must pay for their treatment, their hospital stay and then, if they are long-term patients who were ill before they arrived in Israel, the government must also provide a psychiatric escort to return them home. This has placed a drain on Israeli resources.
No one is certain about exactly what causes Jerusalem Syndrome. It has been posited that it can be very jarring for a serious Bible student to arrive in modern-day Israel where, instead of prophets in sandals, he hears businessmen discussing profits on cell phones. Another theory is that Jerusalem has always been a huge backdrop for delivering messianic messages and visitors can get temporarily carried away by the dramatic historic setting. For the moment, there are no clear 10) ___ and the emphasis is on rapid and effective diagnosis and treatment. Source: Psychology Today (Judith Fein)
ANSWERS: 1) Jerusalem; 2) Syndrome; 3) Land; 4) anxiety; 5) psychiatric; 6) Bible; 7) Pope; 8) Palestinian; 9) medical; 10) answers
March 20, 2017
Obesity is a global health problem, contributing to premature death and morbidity by increasing a person's risk of developing diabetes, hypertension, heart disease and some cancers. While obesity mostly results from lifestyle and cultural factors, including excess calorie intake and inadequate levels of physical activity, it has a strong genomic component. The burden of obesity is, however, not the same across U.S. ethnic groups, with African-Americans having the highest age-adjusted rates of obesity. Interestingly, most of the genomic studies conducted on obesity to date have been in people of European ancestry, despite an increased risk of obesity in people of African ancestry.
According to an article published online the journal Obesity (13 March 2017), an international team of researchers has conducted the first study of its kind to look at the genomic underpinnings of obesity in continental Africans and African-Americans. The study discovered that approximately 1% of West Africans, African-Americans and others of African ancestry carry a genomic variant that increases their risk of obesity, a finding that provides insight into why obesity clusters in families. Results from the study showed that people with genomic differences in the semaphorin-4D (SEMA4D) gene were about six pounds heavier than those without the genomic variant.
This is the first study to use a Genome-Wide Association Study (GWAS) to investigate the genomic basis of obesity in continental Africans. A GWAS compares the genomes of people with and without a health condition - in this case, people who are obese and those who are not -- to search for regions of the genome that contain genomic variants associated with the condition. Most previous studies on obesity using a GWAS have been conducted with populations of European ancestry; these studies wouldn't have found the SEMA4D genomic variant, which is absent in both Europeans and Asians.
According to the authors, by studying people of West Africa, the ancestral home of most African-Americans, and replicating our results in a large group of African-Americans, new insights are now available into biological pathways for obesity that have not been previously explored. The authors added that these findings may also help inform how the African environments have shaped individual genomes in the context of obesity risk.
The authors plan to replicate these findings in more populations and conduct experiments using cell lines and model organisms such as zebrafish to identify the role of genomic variants in SEMA4D in obesity and obesity-related traits. (The SEMA4D gene plays a role in cell signaling, the immune response and bone formation.) Available data show that the newly identified genomic variant overlaps a region of DNA called an enhancer that can be activated to increase the work of a particular gene. The authors plan to conduct larger studies of DNA sequencing of this gene in different human populations with the hope of identifying other genomic factors that may be associated with obesity. The overall goal of the program is to learn how to better prevent or treat obesity.
March 20, 2017
Schizophrenia is associated with an increased risk of type 2 diabetes. However, it is not clear whether schizophrenia confers an inherent risk for glucose dysregulation in the absence of the effects of chronic illness and long-term treatment. As a result, a study published in JAMA Psychiatry (2017;74:261-269) conducted a meta-analysis examining whether individuals with first-episode schizophrenia already exhibit alterations in glucose homeostasis compared with controls.
For the study, the EMBASE, MEDLINE, and PsycINFO databases were systematically searched for studies examining measures of glucose homeostasis in antipsychotic-naive individuals with first-episode schizophrenia compared with individuals serving as controls. Study selection included case-control studies reporting on fasting plasma glucose levels, plasma glucose levels after an oral glucose tolerance test, fasting plasma insulin levels, insulin resistance, and hemoglobin A1c (HbA1c) levels in first-episode antipsychotic-naive individuals with first-episode schizophrenia compared with healthy individuals serving as controls. Two independent investigators selected the studies. Two independent investigators extracted study-level data for a random-effects meta-analysis. Standardized mean differences in fasting plasma glucose levels, plasma glucose levels after an oral glucose tolerance test, fasting plasma insulin levels, insulin resistance, and HbA1c levels were calculated. Sensitivity analyses examining the effect of body mass index, diet and exercise, race/ethnicity, and minimal (<2 weeks) antipsychotic exposure were performed.
Results showed that of the 3,660 citations retrieved, 16 case-control studies comprising 15 samples met inclusion criteria. The overall sample included 731 patients and 614 controls. Fasting plasma glucose levels (P=0.03), plasma glucose levels after an oral glucose tolerance test (P=0.007), fasting plasma insulin levels (P=0.01), and insulin resistance (homeostatic model assessment of insulin resistance) (P=0.001) were all significantly elevated in patients compared with controls. However, HbA1c levels (P=0.55) were not altered in patients compared with controls.
According to the authors, the findings show that glucose homeostasis is altered from illness onset in schizophrenia, indicating that patients are at increased risk of diabetes as a result. The authors added that this finding has implications for the monitoring and treatment choice for patients with schizophrenia.
March 20, 2017Target Healthy Eating
Medium rare lamb pieces, cooked in oil and garlic with a fig reduction, is the topping on the eggplant pancake that you see above. It's garnished with chopped scallion and served with fresh mango and mango chutney.
2 or 3 cups roasted eggplant
2 large eggs, slightly beaten
1 Onion, well chopped
6 fresh garlic cloves, thinly sliced
1/2 cup chickpea flour
1/4 to 1/2 creamy goat cheese or plain Greek yogurt
1/2 teaspoon baking powder
Pinch black pepper
Pinch dried oregano
1 teaspoon curry powder
1/2 cup fresh mint, very finely chopped
1/4 to 1/2 cup canola oil, more if needed
1. Roast 1 or 2 Italian eggplant until the inside is very soft. With an oven mitt on, squeeze the eggplant to feel the degree of softness. Remove from oven when done and (use oven mitts) cut each eggplant in half, and open like a book, to cool, on a plate.
2. When cool enough, throw away any seeds or skin and remove the soft eggplant to a food processor to break up and soften any fibers. Set aside
3. While eggplant is baking, do all your chopping
4. Into a large mixing bowl, add the eggs, garlic, onion and creamy goat cheese, finely chopped parsley. Stir to combine everything well.
5. Add the eggplant from the food processor, to the bowl with mixed wet ingredients.
6. In another bowl, mix the dry ingredients: flour, baking powder, salt, black pepper, curry powder, dried oregano, and fresh mint. Mix well.
7. Slowly, add the mixed dry ingredients to the eggplant mixture and stir until the batter is just moistened. Don't over-mix.
Cooking the Eggplant Pancakes
Heat canola oil in a large skillet over medium-high heat. Drop rounded spoonfuls of eggplant batter into hot oil and fry until golden, 2 to 3 minutes per side. Drain pancakes on a paper towel-lined plate.
March 13, 2017Target Healthy Eating
Several years ago, our son, Alex, introduced us to one of Manhattan's best gourmet vegan restaurants, Candle79. We all go for dinner there, each time he comes to Manhattan. We all love it, by the way. Our strategy at Candle79 (on East 79th Street), is to have 3 or 4 courses, each ordering something different - and sharing. This way, we all get to sample a wide variety of what this inventive restaurant offers. For the appetizer course, one of the dishes was Smoked Paprika Hummus. This and a few other items on the menu, which we ordered, were so-o delicious, that I bought one of the restaurant's cookbooks in order to try their recipes out at home. The recipes are not that difficult. We want to share with our readers, Candle79's Smoked Paprika Hummus recipe, exactly as it appears in their cookbook.
If using dried chickpeas, put them in a saucepan or bowl and add cold water to cover by about 2 inches. Soak in the refrigerator for at least 6 hours or overnight. Drain and rinse.
Put the chickpeas in a saucepan and add cold water to cover by about 2 inches. Bring to a boil, decrease the heat, cover, and simmer until the chickpeas are tender, 50 to 60 minutes. Drain and let cool, reserving 1/4 to 1/2 cup of the cooking water.
Combine the chickpeas, garlic, lemon juice, cayenne, paprika, salt, pepper, parsley, olive oil, and tahini in a bowl and stir to mix well. Transfer the mixture to a food processor fitted with the metal blade and process until well mixed. Add 1/4 cup of the reserved cooking liquid (or water or vegetable stock if using canned chickpeas) and process until smooth and almost fluffy. Add more liquid if necessary. Scrape down the sides of the bowl once or twice. Transfer to a serving bowl and refrigerate for at least 1 hour. (The hummus can be made up to 3 days ahead and refrigerated. Return to room temperature before serving.)
To serve, drizzle a bit of olive oil over the hummus and sprinkle a bit of paprika. Serve with desired garnishes.
Try stuffing chunks of cucumber with this paprika hummus, or mushrooms or deviled eggs.
On an informal Sunday night at home, we find that this hummus is so good, we heat up some pita bread, break out a bottle of our favorite white wine, and just sit at our kitchen table, with raw carrot, celery, and cucumber sticks (and a few olives) and eat this delicious repast with total satisfaction. Sorta like a picnic at home.
See below the wine we enjoyed with the paprika humus.
From Our Table to Yours !
March 13, 2017What's New
The photo below was taken in the front gardens of our building in NYC showing the crocuses pushing through.
On this same morning we had a very cold snow storm, but by the time I was coming home in the afternoon, the sun was out and crocuses blooming.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you'll love the Blog.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Edit
March 13, 2017Regulatory
The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other's good manufacturing practice inspections of pharmaceutical manufacturing facilities. The amended agreement ?represents the culmination of nearly three years of U.S. FDA and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other's borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.
In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections. The FDA was invited to observe the EU's Joint Audit Programme, in which two EU nations audit the inspectorate - the regulatory authority - of another EU country. The FDA first observed the audit of Sweden's inspectorate by auditors from the United Kingdom and Norway. Since then, the FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.