Target Health Inc. Attends Nippon Club Concert in Manhattan


Nippon Club, New York City: The two concert guitarists on either side of Mui Ying Kwan (2nd from the left) from Target Health Inc., are Yasuhito Udaka and Shunsuke Yamashita from Kochi prefecture in Japan. Very popular in Japan, they started a world tour beginning in Taiwan, working their way to Mexico and of course, to New York, where they were a big success. Target Health Inc. has been a member of the Nippon Club since 1993.


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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Vaccines for Children: Pertussis (Whooping Cough)


Updated September 2015


Whooping cough, also called pertussis, starts like a 1) ___. After 1 to 2 weeks, those symptoms give way to intense bouts of coughing that can make it hard to breathe and could make a child or infant, throw up. Whooping cough can lead to complications that can be life-threatening, especially in babies. It may be milder in adults. In 2010, during a pertussis outbreak, ten infants in California died and health authorities declared an epidemic encompassing 9,120 cases. They found that doctors had failed to correctly diagnose the infants’ condition during several visits. Statistical analysis identified significant overlap in communities with a cluster of nonmedical child exemptions and cases. The number of exemptions varied widely among communities but tended to be highly clustered. In some schools more than 3/4 of parents filed for 2) ___ exemptions. The data suggest vaccine refusal based on nonmedical reasons and personal belief exacerbated the outbreak. Other factors included reduced duration of the current vaccine and that most vaccinated adults and older children had not received a booster shot.


In April and May 2012, pertussis was declared to be at epidemic levels in Washington State, with 3,308 cases. In December 2012, Vermont declared an epidemic of 522 cases. Wisconsin had the highest incidence rate, with 3,877 cases, although it did not make an official epidemic declaration.




The bacteria that cause whooping cough (shown above in green) lodge themselves in the small hair-like structures of the airways. The bacteria spread during coughing and sneezing. A person remains contagious from the time the cold symptoms appear and can spread the germs for up to 3 weeks after the coughing spells begin.


Initially symptoms are usually similar to those of the common cold with a runny nose, fever, and mild cough. This is then followed by weeks of severe coughing fits. Following a fit of coughing, a high-pitched 3) ___ sound or gasp may occur as the person breathes in. The coughing may last for more than a hundred days or twelve or more weeks. A person may cough so hard they vomit, break ribs, or become exhausted from the effort. Children less than one year old may have little or no cough and instead have periods where they do not breathe. The period of time between infection and the onset of symptoms is usually seven to ten days. Disease may occur in those who have been vaccinated but symptoms are typically milder. Pertussis is one good reason to get children 4) ___. Urban mythology rumors are influencing parents to stay away from vaccines, because of rumored false dangers. Just the opposite is true. It’s more dangerous not to have children vaccinated.


Pertussis is caused by the bacteria Bordetella pertussis. It is an airborne disease which spreads easily through the coughs and 5) ___ of an infected person. People are infectious to others from the start of symptoms until about three weeks into the coughing fits. Those treated with antibiotics are no longer infectious after five days. Diagnosis is by collecting a sample from the back of the nose and throat. This sample can then be tested by either culture or by polymerase chain reaction. Prevention is mainly by vaccination with the pertussis vaccine. Initial immunization is recommended between six and eight weeks of age with four doses to be given in the first two years of life. The vaccine becomes less effective over time with additional doses often recommended among older children and adults. Antibiotics may be used to prevent the disease among those who have been exposed and are at risk of severe disease. In those with the disease, antibiotics are useful if started within three weeks of the initial symptoms but otherwise have little effect in most people. In children less than one year old and among those who are 6) ___ they are recommended with symptom onset. Antibiotics used include erythromycin, azithromycin, or trimethoprim/sulfamethoxazole. Evidence to support the effectiveness of medications for the cough is poor. Many children less than a year of age require hospitalization.


It is estimated that pertussis affects 16 million people worldwide a year. Most cases occur in the developing world and people of all ages may be affected. In 2013 it resulted in 61,000 deaths – down from 138,000 deaths in 1990. Nearly 2% of infected children less than a year of age die. Outbreaks of the disease were first described in the 16th century. The bacteria that causes the infection was discovered in 1906. The vaccine became available in the 1940s.


Receiving the vaccine or having the disease does not ensure lifelong protective immunity against pertussis. Immunity to the bacteria decreases after five to 10 years following administration of the vaccine. Therefore older children, adolescents and adults are at risk of becoming infected with pertussis and need vaccination. Vaccinating adults is also important because adults can serve as a source of infection for infants, who are at particular risk of having severe illness and serious complications from pertussis. Those who have been vaccinated and still become ill, have a lower risk of complications and often experience less severe symptoms. In most cases, the duration of the cough is shorter and coughing fits are less frequent than in unvaccinated people. The incubation period, or the time frame in which symptoms develop, is longer than that for the common cold and most upper respiratory infections. Typically, signs and symptoms develop within seven to 10 days of exposure to pertussis, but they may not appear for up to three weeks after the initial infection.


The first stage of whooping cough is known as the catarrhal stage. In the catarrhal stage, which typically lasts from one to two weeks, an infected person has symptoms characteristic of an upper respiratory infection. It is important to note that particularly during this early phase of infection, individuals may believe they have a common cold and may not be aware that they are infected with the pertussis bacterium. The cough gradually becomes more severe, and after one to two weeks, the second stage begins. It is during the second stage (the paroxysmal stage) that the diagnosis of whooping cough usually is suspected. The following characteristics describe the second stage:


1. There are bursts (paroxysms) of coughing, or numerous rapid coughs, apparently due to difficulty expelling thick mucus from the airways in the 7) ___. Bursts of coughing increase in frequency during the first one to two weeks, remain constant for two to three weeks, and then gradually begin to decrease in frequency.

2. At the end of the bursts of rapid coughs, a long inspiratory effort (breathing in) is usually accompanied by a characteristic high-pitched whoop sound for which the disease is named.

3. During an attack, the individual may become cyanotic (skin and mucous membranes may turn blue) from lack of 8) ___.

4. Children and young infants appear especially ill and distressed.

5. Vomiting (referred to by doctors as post-tussive vomiting) and exhaustion commonly follow the episodes of coughing.

6. The person usually appears normal between episodes.

7. Paroxysmal attacks occur more frequently at night, with an average of 15-24 attacks per 24 hours.

8. The paroxysmal stage usually lasts from one to six weeks but may persist for up to 10 weeks, or longer.

9. Infants under 6 months of age may not have the strength to have a whoop, but they do have paroxysms of coughing.

The third stage of whooping cough is the recovery or convalescent stage. In the convalescent stage, recovery is gradual. The cough becomes less paroxysmal and usually disappears over two to three weeks; however, paroxysms often recur with subsequent respiratory infections for many months. Everyone should know how to stop the spread of germs. Mouth should be covered when coughing or sneezing. Wash hands afterward and often. And cough or sneeze into an upper sleeve or elbow instead of hands. Babies should be kept away from infected people, because whooping cough can be deadly for them. Children younger than 3 months are most likely to have serious complications. The DTaP vaccine protects infants against whooping cough.


William Schaffner, MD, president of the National Foundation for Infectious Diseases, indicates that the wakeup call for anyone who doubts the effectiveness of childhood vaccinations, should be the recent dramatic deaths of 10 California infants, in 2010 during an outbreak of pertussis; as well as the ongoing outbreaks in Washington State, right now. When asked about risk, Dr Schaffner said, “People will get a sore arm for about a day — anyone who has ever received a tetanus shot knows this is a common reaction.” The biggest 9) ___ is in not getting vaccinated. According to Kathryn M. Edwards MD, a professor of pediatrics and director of Vanderbilt University’s Vaccine Research Program: Pertussis can be passed on to babies without the telltale cough. A simple sneeze — or even just breathing — can spread it to an infant, making it hard for them to drink, eat and breathe. “It can lead to pneumonia, malnutrition, seizures, and lung and heart failure,” Two in three babies under a year old who get whooping cough have trouble breathing. About half the babies who get it end up in the hospital, where staff can monitor breathing, give oxygen if needed, and suction thick discharge.


There are two different vaccines to protect against whooping cough, as well as diphtheria and tetanus: DTaP for children under 7 years and Tdap, which has been given to older children and adults since 2005. Babies should get all doses of the DTaP vaccine on schedule. With five doses of the vaccine in all, between the age of 2 months and 4 to 6 years old. The vaccines will keep a baby about 90% protected from getting whooping cough for at least 1 year after the last dose. Most children won’t get whooping cough for the next 4 years.

Pertussis, or whooping cough, can be prevented with vaccines. Before pertussis vaccines became widely available in the 1940s, about 200,000 children got sick with it each year in the United States and about 9,000 died as a result of the infection. Now we see about 10,000 to 40,000 cases reported each year and unfortunately up to twenty 10) ___.


ANSWERS: 1) cold; 2) vaccination; 3) whoop; 4) vaccinated; 5) sneezes; 6) pregnant; 7) lungs; 8) oxygen; 9) risk; 10) deaths


Pediatrics and Two Extraordinary Pediatricians: Dr. Jacobi & Dr. Denmark


Pediatrics is the branch of medicine that deals with the medical care of infants, children, and adolescents, and the age limit usually ranges from birth up to 18 years of age (in some places until completion of secondary education, and until age 21 in the United States). A medical practitioner who specializes in this area is known as a pediatrician. The word paediatrics and its cognates mean “healer of children“; they derive from two Greek words: pais (child) and iatros (doctor, healer). Pediatricians work both in hospitals, particularly those working in its specialized subfields such as neonatology, and as primary care physicians who specialize in children.


Pediatrics is a relatively new medical specialty. Hippocrates, Aristotle, Celsus, Soranus, and Galen, understood the differences in growing and maturing organisms that necessitated different treatment: Ex toto non sic pueri ut viri curari debent (“In general, boys should not be treated in the same way as men.“ Celsus).


Some of the oldest traces of pediatrics can be discovered in Ancient India where children’s doctors were called askumara bhrtya. Sushruta Samhita an ayurvedic text, composed during the sixth century BCE contains the text about pediatrics. Another ayurvedic text from this period is Kashyapa Samhita. A second century CE manuscript by the Greek physician and gynecologist Soranus of Ephesus dealt with neonatal pediatrics. Byzantine physicians Oribasius, Aetius of Amida, Alexander Trallianus, and Paulus Aegineta contributed to the field. The Byzantines also built brephotrophia (creches). Islamic writers served as a bridge for Greco-Roman and Byzantine medicine and added ideas of their own, especially Haly Abbas, Serapion, Avicenna, and Averroes. The Persian scholar and doctor al-Razi (865-925) published a short treatise on diseases among children. The first book about pediatrics was Libellus [Opusculum] de aegritudinibus et remediis infantium 1472 (“Little Book on Children Diseases and Treatment“), by the Italian pediatrician Paolo Bagellardo In sequence came Bartholom?us Metlinger’s Ein Regiment der Jungerkinder 1473, Cornelius Roelans (1450-1525) no title Buchlein, or Latin compendium, 1483, and Heinrich von Louffenburg (1391-1460) Versehung des Leibs written in 1429 (published 1491), together form the Pediatric Incunabula, four great medical treatises on children’s physiology and pathology.




Portrait of Nils Rosen von Rosenstein


The Swedish physician Nils Rosen von Rosenstein (1706-1773) is considered to be the founder of modern pediatrics as a medical specialty, while his work. The diseases of children, and their remedies (1764) is considered to be “the first modern textbook on the subject“. Pediatrics as a specialized field of medicine continued to develop in the mid-19th century; Abraham Jacobi (1830-1919) is known as the father of pediatrics in the USA because of his many contributions to the field. He was born in Germany, where he received his medical training, but later practiced in New York City.


The first generally accepted pediatric hospital is the Hopital des Enfants Malades (French: Hospital for Sick Children), which opened in Paris in June 1802 on the site of a previous orphanage. From its beginning, this famous hospital accepted patients up to the age of fifteen years, and it continues to this day as the pediatric division of the Necker-Enfants Malades Hospital, created in 1920 by merging with the physically contiguous Necker Hospital, founded in 1778. In other European countries, the Charite (a hospital founded in 1710) in Berlin established a separate Pediatric Pavilion in 1830, followed by similar institutions at Sankt Petersburg in 1834, and at Vienna and Breslau (now Wroclaw), both in 1837. In 1852 Britain’s first pediatric hospital, the Hospital for Sick Children, Great Ormond Streets. The first Children’s hospital in Scotland opened in 1860 in Edinburgh. In the US, the first similar institutions were the Children’s Hospital of Philadelphia, which opened in 1855, and then Boston Children’s Hospital (1869).


First Pediatrician in the United States, Abraham Jacobi MD



Abraham Jacobi MD, 1813-1919



Jacobi Medical Center: Named after Dr. Abraham Jacobi, this medical center was founded in 1955 as Bronx Municipal Hospital Center, the hospital opened concurrent with the opening of the Albert Einstein College of Medicine of the Yeshiva University. For the first time, a medical school and a municipal hospital center entered into a formal affiliation agreement at the same time that they were both being built and created; this affiliation remains until now, and Jacobi Medical Center is a University Hospital of Einstein.


Abraham Jacobi (May 6, 1830 – July 10, 1919) was a pioneer of pediatrics, opening the first children’s clinic in the United States. To date, he is the only foreign-born president of the American Medical Association. He helped found the American Journal of Obstetrics. Born in Hartum (now a district of Hille), Westphalia, he was the son of a poor Jewish shopkeeper and his wife who educated him at great sacrifice. He attended the gymnasium in Minden. After graduating there, he studied medicine at the universities of Greifswald, Gottingen, and Bonn, receiving an MD at Bonn in 1851. Shortly thereafter, Jacobi joined the revolutionary movement in Germany (see Revolution of 1848). He was detained in prisons at Berlin and Cologne in 1851, and eventually convicted of treason and imprisoned at Minden and Bielefeld until his discharge in the summer of 1853. Upon release, Jacobi sailed to England, where he stayed with both Karl Marx and Friederich Engels. In the following autumn he moved to New York where he settled as a practicing physician. He remained in contact with Marx and Engels and in 1857 Jacobi was involved in founding the New York Communist Club. Starting in 1861 at the New York Medical College, he was a professor of childhood diseases. From 1867 to 1870, he was chair of the medical department of the City University of New York. He taught at Columbia University from 1870 to 1902. He later moved to Mount Sinai Hospital, where he established the first Department of Pediatrics at a general hospital. He was president of the New York Pathological and Obstetrical Societies, and twice of the Medical Society of the County of New York, visiting physician to the German Hospital beginning 1857, to Mount Sinai Hospital beginning 1860, to the Hebrew Orphan Asylum and the infant hospital on Randall’s Island beginning 1868, and to Bellevue Hospital beginning 1874. In 1882 he was president of the New York State Medical Society, and in 1885 became president of the New York Academy of Medicine. From 1868 to 1871, he was joint editor of the American Journal of Obstetrics and Diseases of Women and Children.


Civic work was an important part of his life. He advocated birth control and civil service reform and opposed prohibition. He was strongly anti-Hohenzollern during World War I. In the summer of 1918, a house fire destroyed the manuscript of his autobiography and other personal papers at his Lake George home. He died on July 10, 1919 in his summer home in Bolton Landing at age 89. Jacobi is interred at Green-Wood Cemetery in Brooklyn, New York.




Oldest Pediatrician, Leila Alice Denmark MD, 1898-2021 (114 years)



Still practicing medicine at age 103.


Leila Alice Denmark (nee Daughtry; February 1, 1898 – April 1, 2012) was an American pediatrician. She was the world’s oldest practicing pediatrician until her retirement in May 2001 at the age of 103, after 73 years. She was a supercentenarian, living to the age of 114 years, 60 days. On December 10, 2011, at age 113 years 312 days, she became one of the 100 oldest people ever.  At her death she was the 5th-oldest verified living person in the world and the 3rd-oldest verified living person in the United States. As a pioneering female doctor, a medical researcher and an outspoken voice in the pediatric community, Denmark was one of the very few supercentenarians in history to gain prominence in life for reasons other than longevity. She started treating children in 1928, the same year as Mickey Mouse made his debut, and by the time of her retirement was treating grandchildren and great-grandchildren of her first patients.


Born in Portal, Georgia, Denmark was the third of 12 children born to Elerbee and Alice Cornelia Hendricks Daughtry. Her paternal uncle was Missouri Congressman James Alexander Daugherty. She attended Tift College in Forsyth, Georgia, where she trained to be a teacher, but decided to attend medical school when her fiance, John E. Denmark (1899-1990) was posted to Java, Dutch Indies, by the United States Department of State and no wives were allowed. She was the only woman in the 1928 graduating class of the Medical College of Georgia, and married soon after graduation. Denmark is credited as co-developer of the pertussis (whooping cough) vaccine in the 1920s and 1930s. For this, she was awarded the Fisher Prize in 1935. Following graduation, she accepted a residency at Grady Memorial Hospital in Atlanta, Georgia and moved to the Virginia-Highland neighborhood with her husband. Denmark was the first physician on staff at Henrietta Egleston Hospital, a pediatric hospital on the Emory University campus, when it opened. In private practice, she saw patients in a clinic at her home and devoted a substantial amount of her professional time to charity. She never refused a referral from the public health department. On March 9, 2000, the Georgia General Assembly honored her in a resolution.


Denmark outlined her views on child-rearing in her book Every Child Should Have a Chance, published in 1971. She was among the first doctors to object to cigarette smoking around children, and drug use in pregnant women. She believed that drinking cow’s milk is harmful, and that children and adults should eat fruit instead of drinking fruit juices, and drink only water. On her 100th birthday in 1998, she refused cake because there was too much sugar in it. When she refused cake again on her 103rd birthday, she explained to the restaurant’s server that she had not had any food with added sugar in it in 70 years. She wrote a second book, published in 2002, with Madia Bowman titled, Dr. Denmark Said It!: Advice for Mothers from America’s Most Experienced Pediatrician. Denmark lived in Alpharetta, Georgia until age 106, when she moved to Athens, Georgia to live with her only daughter, Mary Hutcherson. On February 1, 2008, Denmark celebrated her 110th birthday, becoming a supercentenarian. According to Hutcherson, Denmark’s health deteriorated severely in the autumn of 2008 but later improved as she neared her 111th birthday. In addition to Hutcherson, her only child, Denmark had two grandchildren, Steven and James, and two great-grandchildren, Jake and Hayden.



For 70 years, she never ate food with added sugar.



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Biomarker Detects Early Breast Cancer


One-third of patients diagnosed with breast cancer eventually develop metastases in distant organs, with an increased risk of death. Breast cancer has a high rate of metastasis to bone, lung, liver, lymph nodes, and the brain. Since small, early-stage cancers are the most responsive to drug treatments, screening is an important aspect of follow-up care for breast cancer patients, and early detection is critical in tailoring appropriate and effective therapeutic interventions. While multiple imaging techniques, including MRI, are currently used in breast cancer detection and clinical management, they are neither able to detect specific cancer types or early cancer growth.


According to an article published online in Nature Communications (12 August 2015), it was shown that magnetic resonance imaging (MRI) can detect the earliest signs of breast cancer recurrence and fast-growing tumors. The approach detects micrometastases, breakaway tumor cells with the potential to develop into dangerous secondary breast cancer tumors elsewhere in the body. The approach may offer an improved way to detect early recurrence of breast cancer in women and men. To detect micrometastases, the authors used MRI imaging — which uses a magnetic field and radio waves to produce images, and combined it with a special chemical contrast solution. The contrast solution that the team developed contains a short piece of protein, or peptide, tagged with a minuscule magnet. The authors chose the peptide-a chain of just five amino acids for its inclination to bind to protein matrix structures around cancer cells, called fibrin-fibronectin complexes. More importantly, the fibronectin part of the complex is expressed during a cell’s transition to cancer and plays a role in cell growth, migration and differentiation. Fibronectin is associated with high-risk breast cancer with poor prognosis.


The authors collected images depicting metastases where breast cancer had spread beyond the original tumors. Metal molecules within the contrast solution are magnetized during the MRI process and enhance the image wherever the molecules of solution bind with the targeted protein. According to the authors, the primary tumor sends signals to distant tissue and organs to prepare the soil for metastasis. Therefore, by also binding with the magnetically tagged peptide, the biomarker is enhanced, generating enough signal for MRI detection of small, high-risk cancer and micrometastases. The authors tested the approach in mice into which they had introduced breast cancer cells. After a two-week waiting period, the researchers injected the contrast solution and performed MRI. The MRI imaging detected metastatic tumors, including micrometastases, in lung, liver, lymph node, adrenal gland, bone, and brains of the mice. Analysis of images showed that the contrast used by the research team bound almost exclusively to the fibrin-fibronectin complexes, producing a strong and prolonged image enhancement of micrometastases and tumors compared with normal tissue. Using a microscopic imaging approach, called cryo-imaging, and MRI, the authors verified that the MRI technique could detect micrometastases, even observing bone micrometastases that were less than 0.5mm — the diameter of a very fine pencil lead.


Prior to the study with this contrast agent, the authors had conducted studies to determine its clearance from the body after the imaging, which is essential for safe clinical use. Their testing showed that the agent is readily cleared from the body and has a low level of retention in tissues. Therefore, they expect it will be safe if ultimately developed for clinical use.


Pelvic Pain May Be Common Among Reproductive-Age Women


According to an article published online in Human Reproduction (12 August 2015), a high proportion of reproductive-age women may be experiencing pelvic pain that goes untreated. The study surveyed more than 400 women who were scheduled to undergo surgery or imaging for such reasons as infertility, menstrual irregularities, tubal sterilization or pelvic pain. As expected, reports of pain were highest for women diagnosed with endometriosis, a disorder in which tissue that normally lines the inside of the uterus grows outside of the uterus. However, one-third of those without any pelvic condition also reported a high degree of ongoing pain or pain recurring during the menstrual cycle.


The study enrolled 473 women ages 18 to 44 years at 14 surgical centers in Salt Lake City and San Francisco. The women were set to undergo either laparoscopy, a surgical procedure which involves inserting a camera at the end of a tube through a tiny incision in the abdomen, or a laparotomy, which involves making a larger incision in the pelvic region. The women were seeking care or treatment for pain, for a mass or lump in the pelvic region, infertility, menstrual irregularities, or for tubal sterilization.


In an interview before their surgery, the women were asked about the kind of pain they had experienced in the past six months, along with its severity. In all, the women were asked if they had more than 17 specific types of pain related to intercourse, their menstrual period, urination or bowel elimination, or other pain, such as muscle or joint pain or migraine headaches.  In addition, they were asked to indicate on diagrams of the pelvic area and of a standing female figure where they felt pain. Results showed that more than 30% of the women reported that they were experiencing chronic pain and cyclic pain — coinciding with an interval during their monthly menstrual cycle — lasting six months or more. This 30% included not only women with pelvic disorders, but also those without any pelvic condition. In addition, regardless of the reason they had surgery or of their diagnosis after the operation, only 3% of the total study population reported having none of the 17 types of pain, while over 60% reported six or more types of pain.


Among the study participants, approximately 40% were diagnosed with endometriosis, and 31% with other conditions, including uterine fibroids, ovarian cysts, and tumors. Nearly 29% had not been diagnosed with any pelvic conditions. Women diagnosed with endometriosis experienced the most chronic pain, at slightly more than 44%, compared to about 30% of women without any pelvic condition. Similarly, women with endometriosis were more likely to experience pain during intercourse, menstrual cramping and pain with bowel elimination. They also were more likely to report vaginal pain and pain in the pelvic-abdominal area. The study authors called for future research on the type and location of pain associated with endometriosis. Results of such studies might lead to better diagnosis and treatment of the disorder. The authors also called for additional research on the causes of pain in women not diagnosed with any pelvic condition.


New Laser-Based Hearing Aid with Potential for Broad Sound Amplification


According to statistics compiled by the National Institute on Deafness and Other Communication Disorders, 37.5 million adults aged 18 and older in America report some form of hearing loss. However, only 30% of adults aged 70 and older and 16 percent of adults aged 20 to 69 who could benefit from wearing hearing aids have ever used them.




Anatomy of the inner ear


The FDA has cleared a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.


The EarLens CHD consists of two parts: a tympanic membrane transducer (TMT), which is non-surgically placed deeply into the ear canal on the eardrum, and a behind-the-ear (BTE) audio processor that sits on the outer ear and is connected to an ear tip that is placed in the ear canal. External sound waves received by the BTE processor are converted to electronic signals, digitally processed, amplified and sent to the ear tip, which contains a laser diode. There, the electronic signals of amplified sound are converted to pulses of light. The laser light pulses then shine onto a photodetector in the TMT, which converts the light back into electronic signals, transmitting sound vibrations directly to the eardrum by direct contact.


The EarLens CHD differs from traditional air conduction hearing aids in several ways. The TMT component is custom-molded to the patient’s eardrum and contains a driver mechanism that directly stimulates the eardrum, enabling efficient amplification of sound (functional gain).


Clinical data supporting the safety and effectiveness of the EarLens CHD included several assessments over a four-month period, such as residual hearing stability, improved word recognition, functional amplification gain and the ability to hear sentences in background noise compared to listening without any amplification. Studies showed that after 30 days of device use, the 48 subjects experienced, on average, a 33% improvement in word recognition. Users also experienced a clinically significant functional gain of 30.5 decibels (dB) on average in the high frequency range (2,000-10,000 Hz), with an average of 30-40 dB of functional gain noted at 6,000 Hz and above and a maximum of 68 dB at 9,000-10,000 Hz, which is not typically achieved with conventional air-conduction hearing aids. Several subjects experienced abrasions in the ear canal, primarily related to ear tip use or the impression-making procedure. There were no serious device-related adverse events.


The FDA reviewed the data for the EarLens CHD through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device. EarLens CHD is manufactured by EarLens Corporation of Menlo Park, California.


Caesar Salad


This is one of the most delicious salads on the planet. I’ve been making Caesar salad for years; stopped for a while, dunno why, but back to perfecting it again. Take it from me, there is no bottled Caesar dressing, that can equal the one you make yourself. Also, for some reason, some restaurants stopped using anchovies and even garlic. Without these two ingredients (and all of the others, too) you may have some kind of salad, don’t know what you would call it; but it ain’t Caesar. ©Joyce Hays, Target Health Inc.





The Dressing


3 anchovy fillets packed in oil, drained

4 fresh garlic cloves

Pinch Kosher salt

1 large egg yolk (boil egg for 1 minute and not longer)

Zest of 1/2 fresh lemon

2 Tablespoons fresh lemon juice, plus more (to your taste)

3/4 teaspoon Dijon mustard

2 Tablespoons excellent olive oil

2 Tablespoons canola oil

6 Tablespoons finely grated FRESH Parmesan +

Pinch black pepper

Worchester sauce (one drop)


The Croutons


1 cup torn 1″ (bite-size) pieces old bread, with crusts

1 Garlic clove, squeezed

2 teaspoons olive oil


The Lettuce


1 head of romaine hearts, leaves separated




Even though the plastic bag may say, pre-washed, I always rinse any leafy veggie under cold water, anyway. Here the romaine is draining. Such beautiful shades of green, fresh and crispy; just what you want for the Caesar. ©Joyce Hays, Target Health Inc.



The Cheese


1 cup FRESHLY GRATED Parmesan, grate it yourself & leave extra on the dining table, so more can be added after serving. Although, you can buy pre-grated parmesan, it’s quite bland compared with the cheese you grate yourself, freshly grated for each recipe.




Gather all the ingredients in one place. ©Joyce Hays, Target Health Inc.




The Croutons, certainly, can be made the day before. Otherwise, make them first, before you make the dressing. Can you buy packaged croutons? Of course, but try to make them yourself. The flavor is so much better. If you’re going to make a really great Caesar salad, you might as well make great tasting croutons. There is simply no comparison! Once you taste the richness of your own croutons, you’ll never buy them again. They’re not a peripheral ingredient, they make the salad better. That’s why they’re in the recipe.


Preheat oven to 375 degrees.


In a medium bowl, add the 2 teaspoons olive oil and the squeezed juice of one fresh garlic clove. Stir

Tear or cut any left-over bread, you have, into (1 inch) bite size pieces, enough for 1 cup (press the bread down a bit, in the measuring cup). Then put the pieces of bread, into the bowl with oil/garlic. My favorite bread for croutons is day old (or older) sour dough bread.

Now, toss the bread pieces or cubes and be sure that the bread cubes are all covered (as much as possible) with the oil mixture. Let them sit for a while to absorb the oil, like 30 to 60 minutes. Stir them around every once in a while

Arrange croutons on a baking sheet or large pan and bake, tossing occasionally, until golden, 10-15 minutes. Watch them carefully. Just a little too long in the oven, and they will burn and won’t be useable for the salad. When golden, remove from oven and set aside to cool.




Croutons are about to go into the oven. You can see that some pieces have more oil than others. Doesn’t matter. Once added to the salad, dressing will rub onto the croutons and they’ll be delicious. ©Joyce Hays, Target Health Inc.



The Dressing


Use a large wood salad bowl:


Boil one large egg for one minute and remove from heat after 1 minute. Immediately run the egg under cold water. Then carefully crack it open, so as not to break the yolk. You have to separate the yolk from the egg white and use only the yolk in this recipe. Separate and put the yolk into a small container, ready to use in the dressing. This is a precaution worth taking, to prevent salmonella. Never use a completely raw egg.

Now, mash all the garlic, right in the wood salad bowl, with a fork. Get it all evenly mashed.




Starting to mash the garlic in our wooden salad bowl. I used to have a wooden salad bowl devoted only for Caesar salad. By doing this, over time, the garlic and oil season the wood. In Santa Fe, at one of our favorite restaurants, we ran into a chef who did the same thing, tableside. Used a favorite wood salad bowl for Caesar salad only. ©Joyce Hays, Target Health Inc.



Next, add the anchovy fillets (to the wood salad bowl) and mash them into the garlic, with the same consistency as the garlic, so you get a paste.

Now, with a small whisk, add the egg yolk and whisk it into the garlic/anchovy paste

Next, add the lemon zest, 2 Tablespoons of fresh lemon juice and whisk; then add the mustard and 1 drop of Worchester sauce, whisk again

Now, add the extra virgin olive oil and whisk it into the dressing.

Add the canola oil drop by drop, while you whisk it into the dressing.

Finally, add the freshly grated parmesan and black pepper (to your taste). Taste to see if the dressing needs more of anything (to your taste). With the anchovies, you may decide not to use any salt. You might want more lemon juice. This is the time to taste and decide.




Freshly grated parmesan means doing it yourself. There’s no substitute. Buying a container that reads “freshly grated“ simply is NOT. After a while, you’ll see, there’s something satisfying about doing it yourself. ©Joyce Hays, Target Health Inc.



Whisk the dressing so it’s thick and glossy.

If you want, you can make the dressing 1 day ahead; however, I think serving right after making the dressing is the very best way to make Caesar salad.

Just before serving, add the croutons and toss. Then add additional freshly grated parmesan and serve.




I always add to the table, a dish with extra, freshly grated parmesan, just in case I didn’t use enough in the dressing. ©Joyce Hays, Target Health Inc.



Tossing the salad. Just about to serve it. Will add more parmesan in a minute. ©Joyce Hays, Target Health Inc.



The proof is in the eating. ©Joyce Hays, Target Health Inc.



We’re trying a super-Tuscan wine, Tignanello – which is a blend of 80% Sangiovese, 15% Cabernet Sauvignon, and 5% Cabernet Franc, from the highly regarded Antinori Estate of fine wines. Scroll down to read more about the history of this wine, worth trying, if you haven’t already. ©Joyce Hays, Target Health Inc.



We started our meal with glasses of full bodied Tignanello, a blend with complex aromas and a long finish, worth paying attention to. Then the Caesar salad, which if made correctly, makes a bold statement to your taste buds. We thought that a white wine, would not push back enough and that this red would be the best to accompany the Caesar. This particular recipe is so-o good, that I made it my whole meal with seconds and thirds. Jules likes more than one dish at dinner, so I created another meatless recipe, experimenting with him for the first time. I call it a Mushroom Medley with Marsala; served with a nice chewy twisted pasta called, Gemelli. I would say that New Yorkers (following the lead of California) are now trending toward more and more meatless meals. I took a chance that the richness of the mushrooms would combine well with the Tignanello wine, and the two were made for each other. This whole meal was simple but beyond delicious. Call us OCDers, but for the thousandth time, we had our yummy lo-cal jello cake for dessert, slathered with cool whip.




Gemelli pasta



More about Tuscan wines from the Antinori Estate:


Giovanni di Piero Antinori joined the Florentine Guild of Vintners in 1385, beginning an oenological legacy that has lasted over 26 generations. Throughout the company’s history, it has remained family-owned and operated. Today, Marchese Piero Antinori directs the long-lived family vision, and his three daughters participate in various activities with the firm. Famed wine consultant Giacomo Tachis began his celebrated tenure with Antinori in 1961, a year that witnessed the inception of new vinification techniques (controlled temperatures, aging in bottle, and barrels comprising a range of types and styles) and the beginning of a revisionist period in the concept of Chianti (which was later actualized in various methods utilized to maximize extraction and aroma). This dynamic period of experimentation continued over the course of several years, with some of the pivotal initiatives including the use of maloactic fermentation for red wines, aging in barrique, and planting of several non-indigenous varietals. he most tangible and compelling evocation of these progressive efforts, of course, is captured in Antinori’s extensive portfolio, which features some of Italy’s most revered and sought-after bottlings. Piero Antinori desired not to recreate a Bordeaux-style claret, but rather, to convey the versatility and finesse of the noble Sangiovese. Drawing upon the consummate skill of Giacomo Tachis, Antinori realized his conception in the form of the second official Super-Tuscan – Tignanello – debuting in 1971 as a blend of 80% Sangiovese, 15% Cabernet Sauvignon, and 5% Cabernet Franc. While second in the Super-Tuscan timeline, its conception entailed several inaugural efforts: It was the first modern wine of Chianti to contain a nontraditional grape -Cabernet Sauvignon – while omitting white grapes, and the premiere wine to be aged in small barrels.



BTW, just to go back to the Caesar: I never promised you a low-cal salad. S.o.rr.y 20151005-12


From Our Table to Yours!


Bon Appetit!