Presentation at the Annual DIA Meeting


Target Health is pleased to announce that Vadim Tantsyura, one of our top Data Managers, has been invited to participate as a speaker on the topic “Lessons Learned in Implementing Risk-Based Monitoring and eSource: The Data Manager’s Expanded Role,“ in the following program entitled:  Risk-Based Monitoring and Data Management, Chair Teresa Ancukiewicz (Boston Scientific Corporation).


See you in Philadelphia (June 29, 2016  4:00 – 5:15 PM).


Long Winded Explanations! – Phil Lavin, PhD inspects Tornado Damage in Naples Florida and Blizzards Hit the East Coast in 2016 and 2015


With climate change, tornados hit Florida two weeks ago. This photo was shot by Phil’s friend Joel Weiss when a tornado hit near his home in Naples FL. As always, Phil was contemplative.




Photo by Joel Weiss ©Target Health Inc. 2016



New Jersey Blizzard of 2016 ©Target Health Inc. 2016



This Was Phil’s House in 2015 ©Target Health Inc. 2015


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


For more information about Target Health contact Warren Pearlson (212 – 681 – 2100 ext. 104). 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



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Zika Virus, Reaching Pandemic Proportions


Aedes aegypti mosquito: Sources: UGA College of Ag & Environmental Sciences; The Guardian


A state of emergency has been declared, as Brazil faces the 1) ___ virus that shrinks babies’ heads. Now, it’s spreading quickly through neighboring countries. Between 2014 and 2015, Brazil has seen the number of babies born with microcephaly – a rare and devastating neurological disorder that causes newborns to develop abnormally small skulls and brains – increase dramatically, from 200 to nearly 3,000. Brazil’s worst affected regions have declared a state of emergency, and health officials are drawing a link between the sudden increase in microcephaly, which can lead to severe brain damage and often 2) ___, and a recent epidemic of the mosquito-borne Zika virus. The Brazilian government estimates that around 1.5 million locals have been infected with the virus since May 2015.


Spread by Aedes aegypti mosquito bites, this is the same mosquito that caries the yellow fever virus, Zika virus usually only causes a mild reaction in children and adults, including symptoms such as an itchy rash, fever, and conjunctivitis. Most people make it through infection with no symptoms at all, which has led experts to refer to it as a “benign disease“. Unfortunately for the many pregnant women living in Brazil – who are now in a complete panic over the potential risk to their unborn children – it could be a completely different story when it comes to newborns. Having identified Zika virus in the placentas of Brazilian children born with microcephaly, it is now suspected that the two are somehow linked, but it is not yet clear how one can cause the other. When the cases of 3) ___ started to soar in November 2015, doctors noticed they coincided with the appearance of the Zika virus in Brazil. They soon discovered that most of the affected mothers reported having Zika-like symptoms during early pregnancy – mild fever, rash, and headaches.“ According to The New York Times, Claudio Maierovitch, director of the department of surveillance of communicable diseases at Brazil’s Health Ministry, has been advising women in the worst affected states to put planned 4) ___ on hold if possible.


Named after the Ugandan forest in which it was first identified back in the 1940s, Zika virus has spread throughout Africa, parts of Asia, and more recently through Latin America, where it’s been reported in countries such as Colombia, Mexico, Venezuela, and recently, Puerto Rico. What’s so concerning about its appearance in Brazil is how incredibly fast it’s been spreading throughout the population. Brazil offers the ideal conditions for Zika to spread so quickly, according to Ana Maria Bispo de Filippis, leader researcher in the team that linked Zika to microcephaly. She added that the country has a susceptible population in which the majority of people never had contact with the disease. The link is not yet certain though, due to the fact that two previous Zika virus epidemics in Micronesia and French Polynesia did not lead to an increase in microcephaly. One explanation for the link may be that a new strain of the virus is spreading through Brazil, according to Alain Kohl, a virologist at the University of Glasgow who studies Zika. Still, even for the fastest evolving organism on the planet, acquiring completely new powers of devastation is rare. A more likely explanation is that the link has simply gone unnoticed so far. It may be that Zika-induced microcephaly occurs only in a small proportion of pregnant women, and none of the previous epidemics have affected a large enough population to raise an alarm. Brazilian federal and local governments are making an effort to eradicate stagnant ponds that could act as 5) ___ grounds for the mosquitos carrying the virus. “This is an unprecedented situation, unprecedented in world scientific research,“ Brazil’s Health Ministry announced.




Zika virus (ZIKV) is a member of the Flaviviridae virus family and the Flavivirus genus and has been known to occur within a narrow equatorial belt from Africa to Asia. In 2014, the virus spread eastward across the Pacific Ocean to French Polynesia, then to Easter Island and in 2015 to Central America, the Caribbean, and South America, where the Zika outbreak has reached 6) ___ levels. Zika virus is related to dengue, yellow fever, Japanese encephalitis, and West Nile viruses, all of which are arthropod-borne flaviviruses. The illness it causes is similar to a mild form of dengue fever, is treated by rest, and cannot be prevented by drugs or vaccines. A link between Zika fever and microcephaly in newborn babies of infected mothers has now been confirmed. In January 2016, the U.S. Centers for Disease Control and Prevention (CDC) issued travel guidance on affected countries, including the use of enhanced precautions and considering postponing travel, and guidelines for pregnant women. Other governments or health agencies soon issued similar 7) ___ warnings, while Colombia, Ecuador, El Salvador, and Jamaica advised women to postpone getting pregnant until more is known about the risks. Along with other viruses in this family, Zika virus is enveloped with a non-segmented, single-stranded, positive-sense RNA genome. The pathogenesis of the virus is hypothesized to start with an infection of dendritic cells near the site of the mosquito bite, followed by a spread to lymph nodes and the bloodstream. Flaviviruses generally replicate in the cytoplasm, but Zika virus antigens have been found in infected cell nuclei. There are two lineages of Zika virus, the African lineage and the Asian lineage. Phylogenetic studies indicate that the virus spreading in the Americas is most closely related to French Polynesian strains. Complete genome sequences of Zika viruses have been published. Recent preliminary findings from sequences in the public domain uncovered a possible change in nonstructural protein 1 codon usage that may increase the viral replication rate in humans. Zika virus, transmitted by daytime-active mosquitoes in the genus Aedes. Studies, show that the extrinsic incubation period in mosquitoes is about 10 days. The vertebrate hosts of the virus are primarily monkeys and humans. Before the current pandemic, which began in 2007, Zika virus “rarely caused recognized ?spillover’ infections in humans, even in highly enzootic areas“. The potential societal risk of Zika virus can be delimited by the distribution of the mosquito species that transmit it (its vectors). The global distribution of the most cited carrier of Zika virus, A. aegypti, is expanding due to global trade and travel. A. aegypti distribution is now the most extensive ever recorded – across all continents including North America and even the European periphery. In 2009, Brian Foy, a biologist from the Arthropod-borne and Infectious Diseases Laboratory at Colorado State University, sexually transmitted Zika virus to his wife. He visited Senegal to study mosquitoes and was bitten on a number of occasions. A few days after returning to the United States, he fell ill with Zika, but not before having had unprotected intercourse with his wife. She subsequently showed symptoms of Zika infection with extreme sensitivity to light. Foy is the first person known to have passed on an insect-borne virus to another human by sexual contact. In 2015, Zika virus RNA was detected in the amniotic fluid of two fetuses, indicating that it had crossed the placenta and could cause fetal infection. On January 20, 2016, scientists from the state of Parana, Brazil, detected genetic material of Zika virus in the placenta of a woman who had undergone an abortion due to the fetus’s microcephaly, which confirmed that the virus is able to pass the 8) ___. As of 2016, no vaccine or preventive drug is available. Symptoms can be treated with paracetamol (acetaminophen/Tylenol), while aspirin and other nonsteroidal anti-inflammatory drugs should be used only when dengue has been ruled out to reduce the risk of bleeding.


In a French Polynesian epidemic, 73 cases of Guillain-Barre syndrome, which can lead to paralysis, and other neurologic conditions occurred in a population of 270,000, which may be complications of Zika virus. After Zika arrived in Brazil, there was a sharp increase in severe neurological and autoimmune problems, including Guillain-Barre syndrome. Researchers in America and other countries have begun work on a vaccine. Unlike the one for Ebola, though, which had been in the pipeline for a decade when the epidemic in West Africa began, a Zika vaccine is at ground zero, which is where potential antiviral drugs are, too. The spread of Zika makes attacking disease-carrying mosquitoes all the more important. Mostly, Zika is transmitted by Aedes aegypti, but Aedes albopictus, found as far north as New York and Chicago, and in parts of southern Europe, can also do the job, though it is not clear how efficiently. A paper published last week in the Lancet shows where Zika could become endemic, but places where air-conditioning, screened windows and mosquito control are the norm are unlikely to see outbreaks flare up. In December, Brazil decreed a national public-health emergency. This enabled the deployment of the army to help 310,000 health workers in the mosquito-eradication drive.


Since November 2015, Brazil has seen nearly 4,000 cases of microcephaly in babies born to women who were infected with Zika during their pregnancies. To put that in perspective, there were only 146 cases in 2014. So far, 46 babies have died. In the United States one Hawaiian baby was born with microcephaly after his mother returned from Brazil. In Illinois, two pregnant women who traveled to Latin America have tested positive for the virus; health officials are monitoring their pregnancies. The CDC is also asking OB-GYNs to review fetal ultrasounds and do maternal testing for any pregnant woman who has traveled to one of the 23 countries where Zika is currently active. In addition, the CDC says there have been documented cases of virus transmission during labor, blood transfusion, laboratory exposure and sexual contact. While Zika has been found in breast milk, it’s not yet confirmed it can be passed to the baby through nursing. With no treatment or 9) ___ available, the only protection against Zika is to avoid travel to areas with an active infestation. Another prevention effort is OX513A, a genetically modified male Aedes aegypti, dubbed by critics as the “mutant mosquito“ or “Robo-Frankenstein mosquito.“ The creation of British company Oxitec, OX513A is designed to stop the spread of Zika by passing along a gene that makes his offspring die. Since females only mate once, in theory this slows the growth of the population. Each OX513A carries a fluorescent marker, so he can be tracked. Key West, Florida, residents gave the genetically modified male his monster nicknames while protesting a trial release of the mosquito in 2012 as a way to combat an outbreak of dengue fever in South Florida. That effort is under review by the FDA. Field trials in Brazil in 2011 were hugely successful, according to Oxitec, by eliminating up to 99% of the target population. A new release of males in the Pedra Branca area of Brazil in 2014 was 92% successful, according to the company. The 10) ___ has also been tested in the Cayman Islands, Malaysia and Panama. Last year, Oxitec announced plans to build an OX513A mosquito production facility in Piracicaba, Brazil, that it says will be able to protect 300,000 residents.


ANSWERS:  1) Zika; 2) death; 3) microcephaly; 4) pregnancies; 5) breeding; 6) pandemic; 7) travel; 8) placenta; 9) vaccine; 10) mosquito


Look at the Tragedy of Microcephaly, Through the Life of Schlitze Surtees, Sideshow Performer (1901-1971)


Because Zika virus can cause microcephaly in new born babies, we thought readers might be interested in reading about a well-known person born with microcephaly and relegated to a circus side show, as a result of his deformity. This case may be as good as anyone could expect. Imagine those people born without any possibility of a career or a life. To this day, not that much is known about the origins of the Zika virus.




Schlitzie (alternatively spelled “Schlitze“ or “Shlitze“; was born on September 10, 1901, possibly in the Bronx. His legal name was Schlitze Surtees. He worked as an American sideshow performer and occasional actor, best known for his role in the 1932 movie Freaks. His lifelong career on the outdoor entertainment circuit as a major sideshow attraction with Barnum & Bailey, among others, made him a popular cultural icon.


Schlitzie’s true birthdate, name, and location are unknown; the information on his death certificate and gravesite indicate that he was born on September 10, 1901, in The Bronx, New York, though some sources have claimed that he was born in Santa Fe, New Mexico. Claims that he was born in Yucatan, Mexico, are mistaken reflections of Schlitzie’s occasional fanciful billing as “Maggie, last of the Aztec Children“. Information about Schlitzie’s identity at birth may never be known, the information having been lost as he was handed off to various carnivals in a long line of mostly informal guardianships throughout his career.


Schlitzie was born with microcephaly, a neurodevelopmental disorder that left him with an unusually small brain and skull, a small stature (he stood about four feet tall (122 cm)), myopia, and moderate to severe mental retardation. It is possible that these features may have been caused by Seckel syndrome. It was said Schlitzie had the cognizance of a three-year-old: he was unable to fully care for himself and could speak only in monosyllabic words and form a few simple phrases. However, he was able to perform simple tasks and it is believed that he could understand most of what was said to him, as he had a very quick reaction time and the ability to mimic. Those who knew Schlitzie described him as an affectionate, exuberant, sociable person who loved dancing, singing and being the center of attention, performing for anyone he could stop and talk with.


On the sideshow circuit, microcephalics were usually promoted as “pinheads“ or “missing links“, and Schlitzie was billed under such titles as “The Last of the Aztecs“, “The Monkey Girl“, and “What Is It?“. In some sideshows, he was paired with another microcephalic. Schlitzie was often dressed in a muumuu and either presented as female or androgynous to add to the mystique of his unusual appearance. Those who knew him alternately used masculine and feminine pronouns. His urinary incontinence, which obligated him to wear diapers, made dresses practical for his care needs, although it is possible that the incontinence didn’t develop until later in life, and was simply a side-effect of age. The sideshow circuit was a tremendous success for Schlitzie; throughout the 1920s and 1930s he was employed by many upscale circuses, including Ringling Bros. and Barnum & Bailey Circus, Clyde Beatty Circus, Tom Mix Circus, Crafts 20 Big Shows and Foley & Burke Carnival. In 1928, Schlitzie made his film debut in The Sideshow, a drama set in a circus, and which featured a variety of actual sideshow performers. Schlitzie landed his most-known role as an actor in Tod Browning’s 1932 horror film Freaks. Like The Sideshow, Freaks takes place at a carnival, and features a number of genuine sideshow performers: conjoined twins Daisy and Violet Hilton, “The Living Torso“ Prince Randian, and dwarf siblings Harry and Daisy Earles among them. Schlitzie has a scene of (unintelligible) dialogue with actor Wallace Ford. Two other “pinheads“ also appear in the film. When referring to Schlitzie, other actors use feminine pronouns. When Freaks premiered in 1932, cinema audiences were scandalized by the appearance of sideshow performers. The United Kingdom banned the film for thirty years. The film was a financial failure, and Browning, although he went on to make several more films for MGM, retired in 1940. Schlitzie appeared in bit roles in various movies, and is credited with a role in the 1934 exploitation film: Tomorrow’s Children, as a mentally defective criminal who undergoes forced sterilization. He is often widely cited as appearing in 1932’s Island of Lost Souls, in a seconds-long role as “Furry Mammal“; however, there has been some debate about whether the performer in these films is Schlitzie or a look-alike. While Schlitzie was performing with the Tom Mix Circus in 1935, George Surtees, a chimpanzee trainer with a trained-chimpanzee act in the show, adopted him, becoming his legal guardian. In 1941, Schlitzie appeared in his final film role as “Princess Bibi“, a sideshow attraction, in Meet Boston Blackie.


Under Surtees’ care, Schlitzie continued performing the sideshow circuit; after George Surtees’ death in 1965, his daughter, who was not in show business, committed Schlitzie to a Los Angeles county hospital. Schlitzie remained hospitalized for some time until he was recognized by sword swallower Bill Unks, who happened to be working at the hospital during the off-season. According to Unks, Schlitzie seemed to miss the carnival dearly, and being away from the public eye had made him very depressed. Hospital authorities determined that the best care for Schlitzie would be to make him a ward of Unks’ employer, showman Sam Alexander, and return him to the sideshow where he remained until 1968. In his later years, Schlitzie lived in Los Angeles, occasionally performing on various sideshow circuits both locally and internationally (he frequently performed in Hawaii and London, and his last major appearance was at the 1968 Dobritch International Circus held at the Los Angeles Sports Arena). Schlitzie also became a notable attraction performing on the streets of Hollywood, his caretakers selling his stock carnival souvenir pictures. Schlitzie spent time in his final days living on Santa Monica Boulevard. He liked going to MacArthur Park at Alvarado Street and Wilshire Boulevard where he would visit the lake with his guardian, feeding the pigeons and ducks and performing for passersby.


On September 24, 1971, at seventy years old, Schlitzie died from bronchial pneumonia at Fountain View Convalescent Home. His death certificate listed his official name as “Shlitze Surtees“ and his birthdate as 1901. Schlitzie was initially interred in an unmarked grave at Queen of Heaven Cemetery in Rowland Heights, CA. In 2009, a fan took up a collection to have a marker placed at his grave.


In the 1960s, Freaks was rediscovered and enjoyed a long run as one of the first midnight movies, becoming a cult classic, and in 1994, it was selected by the National Film Registry as being “culturally, historically, or aesthetically significant“. The film became the public’s major exposure to Schlitzie, who remains one of the more memorable characters in the film. Schlitzie’s iconic image has lent itself to many products, including masks, hats, shirts, models, clocks, snow globes and dolls. Additionally, Schlitzie has been cited as an inspiration for Bill Griffith’s comic strip Zippy the Pinhead.


Tracing the cause or origin of Schlitzie’s microencephaly is not possible since it’s not known who his mother was or what could have taken place during her pregnancy, to cause Schlitzie’s tragic condition. In 2016, the biographic account of Schlitzie will be featured in a new documentary, titled Schlitzie: One of Us, currently in pre-production.


Zika Virus:


In 1947 scientists researching yellow fever placed a rhesus macaque in a cage in the Zika Forest (zika meaning “overgrown“ in the Luganda language), near the East African Virus Research Institute in Entebbe, Uganda. The monkey developed a fever, and researchers isolated from its serum a transmissible agent that was first described as Zika virus in 1952. It was subsequently isolated from a human in Nigeria in 1954. From its discovery until 2007, confirmed cases of Zika virus infection from Africa and Southeast Asia were rare. In April 2007, the first outbreak outside of Africa and Asia occurred on the island of Yap in the Federated States of Micronesia, characterized by rash, conjunctivitis, and arthralgia, which was initially thought to be dengue, Chikungunya, or Ross River disease. However, serum samples from patients in the acute phase of illness contained RNA of Zika virus. There were 49 confirmed cases, 59 unconfirmed cases, no hospitalizations, and no deaths. More recently, epidemics have occurred in Polynesia, Easter Island, the Cook Islands, and New Caledonia. Since April 2015, a large, ongoing outbreak of Zika virus that began in Brazil has spread to much of South and Central America, and the Caribbean. In January 2016, the CDC issued a level 2 travel alert for people traveling to regions and certain countries where Zika virus transmission is ongoing. The agency also suggested that women thinking about becoming pregnant should consult with their physicians before traveling. Governments or health agencies of the United Kingdom, Ireland, New Zealand, Canada, and the European Union soon issued similar travel warnings. In Colombia, Minister of Health and Social Protection Alejandro Gaviria Uribe recommended to avoid pregnancy for eight months, while the countries of Ecuador, El Salvador, and Jamaica have issued similar warnings. Plans were announced by the authorities in Rio de Janeiro, Brazil, to try to prevent the spread of the Zika virus during the 2016 Summer Olympic Games in that city.


According to the CDC, Brazilian health authorities reported more than 3,500 microcephaly cases between October 2015 and January 2016. Some of the affected infants have had a severe type of microcephaly and some have died. The full spectrum of outcomes that might be associated with infection during pregnancy and the factors that might increase risk to the fetus are not yet fully understood. More studies are planned to learn more about the risks of Zika virus infection during pregnancy. In the worst affected region of Brazil approximately 1% of newborns are suspected of microcephaly.


Schizophrenia’s Strongest Known Genetic Risk Deconstructed


Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. People with schizophrenia may seem like they have lost touch with reality. Although schizophrenia is not as common as other mental disorders, the symptoms can be very disabling. Symptoms of schizophrenia usually start between ages 16 and 30. In rare cases, children have schizophrenia too. The symptoms of schizophrenia fall into three categories: positive, negative, and cognitive. “Positive“ symptoms are psychotic behaviors not generally seen in healthy people. People with positive symptoms may “lose touch“ with some aspects of reality. Symptoms include: hallucinations, delusions, thought disorders (unusual or dysfunctional ways of thinking) and movement disorders (agitated body movements). “Negative“ symptoms are associated with disruptions to normal emotions and behaviors. Symptoms include: “flat affect“ (reduced expression of emotions via facial expression or voice tone), reduced feelings of pleasure in everyday life, difficulty beginning and sustaining activities and Reduced speaking. For some patients, the cognitive symptoms of schizophrenia are subtle, but for others, they are more severe and patients may notice changes in their memory or other aspects of thinking. Symptoms include: poor “executive functioning“ (the ability to understand information and use it to make decisions), trouble focusing or paying attention and problems with “working memory“ (the ability to use information immediately after learning it).


According to a study published in Nature (27 January 2016), versions of a gene linked to schizophrenia  may trigger runaway pruning of the teenage brain’s still-maturing communications infrastructure. According to NIH, normally, pruning gets rid of excess connections we no longer need, streamlining our brain for optimal performance, but too much pruning can impair mental function. This could help explain schizophrenia’s delayed age-of-onset of symptoms in late adolescence/early adulthood and shrinkage of the brain’s working tissue. Interventions that put the brakes on this pruning process-gone-awry could prove transformative.


Affecting about 1% of the population, schizophrenia is known to be as much as 90% heritable, yet discovering how specific genes work to confer risk has proven elusive, until now. However, the gene, called C4 (complement component 4), sits in by far the tallest tower on schizophrenia’s genomic “skyline“ of more than 100 chromosomal sites harboring known genetic risk for the disorder. For the study, the authors leveraged the statistical power conferred by analyzing the genomes of 65,000 people, 700 postmortem brains, and the precision of mouse genetic engineering to discover the secrets of schizophrenia’s strongest known genetic risk. According to the results C4’s role represents the most compelling evidence, to date, linking specific gene versions to a biological process that could cause at least some cases of the illness.


To discover how the immune-related site confers risk for the mental disorder, the authors mounted a search for “cryptic genetic influences“ that might generate “unconventional signals.“ C4, a gene with known roles in immunity, emerged as a prime suspect because it is unusually variable across individuals. It is not unusual for people to have different numbers of copies of the gene and distinct DNA sequences that result in the gene working differently. The authors dug deeply into the complexities of how such structural variation relates to the gene’s level of expression and how that, in turn, might relate to schizophrenia. It was discovered that structurally there are distinct versions that affect expression of two main forms of the gene in the brain. The more a version resulted in expression of one of the forms, called C4A, the more it was associated with schizophrenia. The more a person had the suspect versions, the more C4 switched on and the higher their risk of developing schizophrenia. Moreover, in the human brain, the C4 protein turned out to be most prevalent in the cellular machinery that supports connections between neurons.


Adapting mouse molecular genetics techniques for studying synaptic pruning and C4’s role in immune function, the authors also discovered a previously unknown role for C4 in brain development. During critical periods of postnatal brain maturation, C4 tags a synapse for pruning by depositing a sister protein in it called C3. Again, the more C4 got switched on, the more synapses got eliminated. In humans, such streamlining/pruning occurs as the brain develops to full maturity in the late teens/early adulthood – conspicuously corresponding to the age-of-onset of schizophrenia symptoms.


According to the authors, future treatments designed to suppress excessive levels of pruning by counteracting runaway C4 in at risk individuals might nip in the bud a process that could otherwise develop into psychotic illness, and thanks to the head start gained in understanding the role of such complement proteins in immune function, such agents are already in development.


More Than 1 in 20 U.S. Children Have Dizziness/Balance


Previous estimates of dizziness and balance problems in children have ranged from 5-18% and have been based on limited, foreign, population-based studies. According to a study published online in The Journal of Pediatrics (27 January 2016), to better understand the prevalence of these problems among U.S. children, data were analyzed data from the Child Balance Supplement to the 2012 National Health Interview Survey (NHIS). The NHIS is an annual survey conducted by the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention (CDC). The survey uses personal household interviews to gather information about a range of health topics. The Child Balance Supplement was included in 2012 and was the first large-scale supplement added to the NHIS survey to assess dizziness and balance problems among children.


For the study, the authors analyzed data on nearly 11,000 children, ages 3 to 17, based on parents’ responses to the survey. Parents were asked if in the past year, their children had been bothered by symptoms of dizziness or balance problems such as vertigo, poor balance/unsteadiness when standing up, clumsiness/poor coordination, frequent falls, fainting or light-headedness, or other dizziness and balance symptoms. Results show that more than 1 in 20 (nearly 3.3 million) children between the ages of 3 and 17 have a dizziness or balance problem. Prevalence increases with age, with 7.5% of children ages 15-17 and 6.0% of children ages 12-14 having any dizziness or balance problem, compared with 3.6% of children ages 6-8 and 4.1% of children ages 3-5. The study also found that girls have a higher prevalence of dizziness and balance problems compared to boys, 5.7% and 5.0%, respectively. In addition, non-Hispanic white children have an increased prevalence of dizziness and balance problems (6.1%) compared with Hispanic (4.6%) and non-Hispanic black (4.3%) children.


The authors report that:


1. Among children with dizziness and balance problems, 46.0% of parents reported that the children had poor coordination; 35.1% reported light-headedness; 30.9% had poor balance; 29.0% had vertigo; 25.0% reported frequent falls; and 8.5% had other dizziness and balance problems.


2. Parents reported moderate or serious difficulties in 18.6% of children with dizziness and balance problems.


3. Overall, 36.0% of children with dizziness and balance problems were seen by a health professional and 29.9% received treatment. Of those whose parents reported moderate or serious difficulties with dizziness and balance problems, 71.6% were seen by a health professional, and 62.4% were treated.


The authors also found that only one-third, or 32.8%, of parents with a child with a dizziness or balance problem reported having received a diagnosis of an underlying condition. The percentage of children diagnosed rose to 59.6% among children whose parents reported they had moderate to serious difficulties with dizziness and balance problems. Reported causes included neurological problems; ear infections; head or neck injuries or concussions; developmental motor coordination disorder; genetic causes; metabolic problems such as hypoglycemia; prescription medication or drugs; severe headaches or migraines; malformation of the ear; and vision problems.


Children with any reported difficulty hearing were two times more likely to have dizziness or balance problems compared with children who had normal hearing. Other risk factors associated with dizziness and balance problems included impairments that limit a child’s ability to crawl, walk, run or play; frequent headaches or migraines; certain developmental delays; a history of seizures in the past 12 months; stuttering/stammering; and anemia during the last 12 months. The analysis also revealed gender-specific risk factors. For example, attention deficit hyperactivity disorder, attention deficit disorder, and stuttering were linked to dizziness and balance problems in boys, while anemia, hearing difficulties, and respiratory allergies were associated with the condition in girls. Girls with dizziness and balance problems also reported having more headaches and migraines compared to boys with dizziness and balance problems.


According to the authors, the findings are consistent with the limited prevalence data in other countries, and provide much-needed baseline estimates of dizziness and balance problems in U.S. children, and that dizziness and balance problems in children continue to be an understudied area, and we hope that this analysis leads to a better understanding of the scope and risk factors associated with these issues.


FDA Approves First Drug to Show Survival Benefit in Liposarcoma


Soft tissue sarcoma (STS) is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. Liposarcoma is a specific type of STS that occurs in fat cells and can form almost anywhere in the body, but is most common in the head, neck, arms, legs, trunk and abdomen. In 2014, an estimated 12,000 cases of STS were diagnosed in the US, according to the National Cancer Institute.


The FDA has approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma that cannot be removed by surgery or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. The efficacy and safety of Halaven were evaluated in 143 clinical trial participants with advanced liposarcoma that was unresectable or had spread to nearby lymph nodes (locally advanced) or other parts of the body (metastatic), and who had been treated with chemotherapy. Participants were treated with either Halaven or another chemotherapy drug called dacarbazine until their disease spread or until they were no longer able to tolerate the side effects of treatment. The study was designed to measure the length of time from the start of treatment until a patient’s death (overall survival). Results showed that the median overall survival for patients with liposarcoma receiving Halaven was 15.6 months compared to 8.4 months for those who received dacarbazine.


The most common side effects among participants treated with Halaven were fatigue, nausea, hair loss (alopecia), constipation, certain nerve damage causing weakness or numbness in the hands and feet (peripheral neuropathy), abdominal pain and fever (pyrexia). Halaven may also cause low levels of infection-fighting white blood cells (neutropenia) or decreased levels of potassium or calcium. Serious side effects from treatment with Halaven may include a decrease in white blood cell count, which can increase the risk of serious infections that could lead to death; numbness, tingling or burning in the hands and feet (neuropathy); harm to a developing fetus; as well as changes in heartbeat (QTc prolongation), that may also lead to death.


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


Halaven is marketed by Eisai based in Woodcliff Lake, New Jersey.


Carrot Puree with Mint-Garlic Yogurt Sauce & Warm Pita


Taking carrots to a whole new level  ©Joyce Hays, Target Health Inc.





2 pounds carrots, peeled and sliced

1 teaspoon cumin seeds, lightly toasted and ground

3/4 teaspoon caraway seeds, ground

1 teaspoon coriander

1 teaspoon cardamom

1 teaspoon black sesame seeds (toast them)

1 teaspoon black mustard seeds (toast them)

1/2 teaspoon chili flakes

Pinch Salt & black pepper (or to taste)

3 Tablespoons extra virgin olive oil

2 Tablespoons fresh lemon juice (to taste)




Chopping fresh mint leaves, for the yogurt sauce. ©Joyce Hays, Target Health Inc.



Yogurt Sauce


1/2 cup thick Greek style plain low-fat yogurt

3 garlic cloves, mashed to a puree with salt to taste with a fork or in a mortar and pestle

1 Tablespoon extra virgin olive oil

1 Tablespoon fresh lemon juice

1 Tablespoon finely chopped mint






Steam the carrots above 1 inch of boiling water for 15 minutes or until soft. Remove from the heat and transfer to a food processor.




Steaming the carrots ©Joyce Hays, Target Health Inc.



Pulse the carrots in the food processor and scrape down the sides of the bowl. Turn on the food processor and while the machine is running, pour in the olive oil and lemon juice. Process until the carrots are pureed. Stop the machine and scrape down the sides of the bowl with a spatula.




Toasting the cumin seeds, black sesame seeds & black mustard seeds together (in extra virgin olive oil). ©Joyce Hays, Target Health Inc.



Add the cumin seeds, caraway seeds, black sesame seeds, black mustard seeds, chili flakes, and all the other seasonings, and pinch salt, pinch black pepper and process until everything is well mixed. Taste and adjust seasonings.




Pulsing the carrots and adding rest of ingredients to food processor. ©Joyce Hays, Target Health Inc.



Scrape all the carrot puree out of the food processor, with a spatula, and put into a serving bowl.




Here all the ingredients for the yogurt sauce, have been added and mixed, except for the chopped mint leaves. ©Joyce Hays, Target Health Inc.



Seasoned yogurt: combine all of the ingredients and mix together until well combined. Make a well in the middle of the carrots and spoon in the seasoned yogurt.

Just before serving warm the carrots up in the microwave.

Transfer the carrot puree to a platter. Add the seasoned yogurt to the middle of the carrot puree, and warm pita bread around it.




In this photo, carrots are served as a warm dip with yogurt sauce and warm pita. ©Joyce Hays, Target Health Inc.



Serve the carrot puree as a warm or cold dip, with pita triangles, crudites; or as an appetizer with an assortment of breads and rolls. Or serve the carrot puree as a warm vegetable or side dish. Any way you serve it, you can’t go wrong. We like both.


I’ve been experimenting with interesting, delicious and colorful ways to prepare healthy vegetables. Some of our favorites are broccoli, cauliflower, zucchini, butternut squash and somehow I left out carrots. Carrots always seemed to be relegated to banal roles: crudit?s, stews, chicken soup, or some peripheral ingredient. Dunno exactly why. So, in this recipe, I am attempting to compensate for my lack of carrot creativity, by sharing with you my really yummy carrot recipe that is versatile. I’m using the spices for this carrot recipe, in many other recipes as well. We’ve developed a taste for all of these wonderful spices, so I tend to use some or all in many other creations. We now love my concoctions, using spices from the Middle East, Northern Africa and India. I have graduated to toasting seeds myself and grinding spices in a mortar & pestle; garlic is prepared in many ways: sliced, squeezed, minced, mashed, crushed and all are good.


We began this meal with chilled Pinot Grigio and black and green olives, plus one of our favorite salads, Ugli, which is Ugli, Beefsteak or Heirloom tomatoes cut up with avocado, freshly squeezed garlic, endive, thinly sliced cucumber circles, tiny green olives, all in a simple extra virgin olive oil/fresh lemon juice dressing. Next came another of my new recipes, salmon cakes, Japanese sweet potatoes with a parsley-garlic stuffing, and the carrot puree that you see, with toasted black mustard & sesame seeds. The salmon cakes had a simple dressing, and the carrot puree had a yogurt dressing, served with warm pita bread. I’ve been trying to create recipes for healthy fresh vegetables with spices that add a unique and wonderful taste. This was a dinner filled with fabulous flavors, and if I do say so myself, everything worked together very well. For dessert, we had an experimental pineapple bourbon upside down cake, which was delicious but didn’t look it (needs more experimentation).


This weekend we saw a brilliant production of Arthur Miller’s, “View From the Bridge.“ We’ve always responded to the writing skills of Arthur Miller, but this production took genius to a whole new level. Whoever conceived of the idea to pare this play, down to the bare bone basic Greek allegorical (or Shakespearean) tragedy that it is, gave the audience a precious jewel of a play, and a theatrical experience, never to be forgotten.


If you love the arts, especially theater when it is superb, run to get tickets to this particular production. You will never see View From the Bridge, done this well again. BTW, you have to allow this production to grow on you. It took me 1 hour to “get it.“ After that, I was overtaken with emotion. Miller feels compassion for all his characters and so does the audience, You will not leave the theater without a profound cathartic awareness of what it is to be human, the sorrow of it (a few laughs thrown in). You have our promise that you will not be disappointed. This is theater at its best!




An old standby, chilled Santa Margherita, Pinot Grigio. ©Joyce Hays, Target Health Inc.



From Our Table to Yours!


Bon Appetit!