Judy Schloss Markowitz is Now a Retiree

 

From the desk of Dave Luke, PharmD, Sr. Director, Clinical and Scientific Affairs at Target Health Inc.

 

Target Health Inc. is announcing the retirement of a longtime colleague, Judith (Judy) Schloss Markowitz. Judy is a first generation American whose mother, Ruth, is a Holocaust survivor, and her father immigrated from Germany to the US when he was 2 years of age. A true New Yorker from Queens, with an accent and attitude to prove it, Judy graduated with a Master’s degree in Education from Queens College, CUNY.

 

Judy joined PhRMA as a clinical monitor at Ives Laboratories – which was then a division of American Home Products (AHP). She then watched the industry merge over her 32 year career from AHP to Ayerst Laboratories, to Wyeth-Ayerst, to Wyeth and finally to Pfizer. Judy joined Target Health as Senior Clinical Project Manager in 2010.

 

I had the privilege of meeting Judy 18 months ago when I joined Target Health. Judy helped me onboard and we worked very closely on many time-critical projects. I depended on Judy as a very experienced project manager and I will miss her more than I think she will miss her role. Over the last 5 weeks, I keep catching myself saying “What would Judy do?“ I don’t know the answer but Judy is just a phone call away. Judy will be missed but not easily forgotten.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

To unsubscribe from the On Target mailing list, click on the following link: unsubscribeontarget@targethealth.com

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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The Apgar Score

Mind map showing summary for the Apgar score – Graphics credit: Madhero88 – Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=10396636

 

 

Apgar score is a method to quickly summarize the health of newborn 1) ___ against infant mortality. Dr. Virginia Apgar, an anesthesiologist at New York-Presbyterian Hospital, developed the score in 1952 to quantify the effects of obstetric anesthesia on babies. The Apgar 2) ___ is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).

 

The five criteria of the Apgar score:

Score of 0 Score of 1 Score of 2 Component of backronym
Skin color blue or pale all over blue at extremities
body pink
(acrocyanosis)
no cyanosis
body and extremities pink
Appearance
Pulse rate absent < 100 beats per minute > 100 beats per minute Pulse
Reflex irritability grimace no response to stimulation grimace on suction or aggressive stimulation cry on stimulation Grimace
Activity none some flexion flexed arms and legs that resist extension Activity
Respiratory effort absent weak, irregular, gasping strong, robust cry Respiration

 

 

The test is generally done at 1 and 5 minutes after 3) ___ and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts. A low score on the one-minute test may show that the neonate requires medical attention but does not necessarily indicate a long-term problem, particularly if the score improves at the five-minute test. An Apgar score that remains below 3 at later times, such as 10, 15, or 30 minutes, may indicate longer-term neurological damage, including a small but significant increase in the risk of cerebral palsy. However, the Apgar test’s purpose is to determine quickly whether or not a newborn needs immediate medical care. It is not designed to predict 4) ___-term health issues. A score of 10 is uncommon, due to the prevalence of transient cyanosis, and does not substantially differ from a score of 9. Transient cyanosis is common, particularly in babies born at high altitude. Cyanosis is defined as the 5) ___ or purplish discoloration of the skin or mucous membranes due to the tissues near the skin surface having low oxygen saturation.

A study that compared babies born in Peru near sea level with babies born at very high 6) ___ (4340 m or 14,138 ft) found a significant average difference in the first Apgar score but not the second. Oxygen saturation (see pulse oximetry) also was lower at high altitude.

 

Some ten years after initial publication, a backronym for APGAR was coined in the United States as a mnemonic learning aid: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration.

 

Spanish: Apariencia, Pulso, Gesticulacion, Actividad, Respiracion;

Portuguese: Aparencia, Pulso, Gesticulacao, Atividade, Respiracao;

French: Apparence, Pouls, Grimace, Activite, Respiration;

German: Atmung, Puls, Grundtonus, Aussehen, Reflexe, representing the same tests but in a different order (respiration, pulse, muscle tone, appearance, reflex).

 

Another eponymous backronym from Virginia Apgar’s name is American Pediatric Gross Assessment Record.

Another mnemonic for the test is “How Ready Is This Child?“, which summarizes the test criteria as Heart rate, Respiratory effort, Irritability, Tone, and Color.

 

Neonatal nursing is a subspecialty of nursing care for newborn infants up to 28 days after birth. The term neonatal comes from neo, “new“, and natal, “pertaining to birth or origin“. Neonatal 7) ___ requires a high degree of skill, dedication and emotional strength as the nurses care for newborn infants with a range of problems, varying between prematurity, birth defects, infection, cardiac malformations and surgical problems. Neonatal nurses are a vital part of the neonatal care team and are required to know basic newborn resuscitation, be able to control the newborn’s temperature and know how to initiate cardiopulmonary and pulse oximetry monitoring. Most neonatal nurses care for infants from the time of birth until they are discharged from the hospital. Approximately 40,000 low-birth-weight infants are born annually in the United States. In the United States, Healthcare institutions have varying entry-level requirements for neonatal nurses. Neonatal nurses are Registered Nurses (RNs), and therefore must have an Associate of Science in Nursing (ASN) or Bachelor of Science in Nursing (BSN) degree. Some countries or institutions may also require a midwifery qualification. Some institutions may accept newly graduated RNs who have passed the NCLEX exam; others may require additional experience working in adult-health or medical/surgical nursing. Some countries offer postgraduate degrees in neonatal nursing, such as the Master of Science in Nursing (MSN) and various doctorates. A nurse practitioner may be required to hold a postgraduate degree. The National Association of Neonatal Nurses recommends two years’ experience working in a NICU before taking graduate classes. 8) ___ nurses must complete the Neonatal Resuscitation Program. Some units prefer new graduates who do not have experience in other units, so they may be trained in the specialty exclusively, while others prefer nurses with more experience.

 

Intensive care nurses receive intensive didactic and clinical orientation, in addition to their general nursing knowledge, to provide highly specialized care for critical patients. Their competencies include the administration of high-risk medications, management of high-acuity patients requiring ventilator support, surgical care, resuscitation, advanced interventions such as extracorporeal membrane oxygenation or hypothermia therapy for neonatal encephalopathy procedures, as well as chronic-care management or lower acuity cares associated with premature infants such as feeding intolerance, phototherapy, or administering antibiotics. NICU RNs undergo annual skills tests and are subject to additional training to maintain contemporary practice.

 

The Apgar scoring system was intended as an evaluative measure of a newborn’s condition at and of the need for immediate attention. In the most recent past, individuals have unsuccessfully attempted to link Apgar scores with long-term developmental outcomes. This practice is not appropriate, as the Apgar score is currently defined. Expectant parents need to be aware of the limitations of the Apgar score and its appropriate uses. The Apgar score is performed at 1 and 5 minutes of 9) ___10) ___ scoring is best used in conjunction with additional evaluative techniques such as physical assessment and vital signs.

 

ANSWERS: 1) babies; 2) scale; 3) birth; 4) long; 5) bluish; 6) altitude; 7) nursing; 8) Neonatal; 9) life; 10) Apgar

 

Virginia Apgar

Dr. Virginia Apgar Photograph from Public Information Department, The National Foundation (the March of Dimes). Forms part of New York World-Telegram and the Sun Newspaper Photograph Collection (Library of Congress). Photo credit: March of Dimes – Library of Congress, Public Domain, https://commons.wikimedia.org/w/index.php?curid=43770603

 

Virginia Apgar (June 7, 1909 – August 7, 1974) was an American obstetrical anesthesiologist, best known as the inventor of the Apgar score, a way to quickly assess the health of a newborn child immediately after birth. She was a leader in the fields of anesthesiology and teratology, and introduced obstetrical considerations to the established field of neonatology. The youngest of three children, Apgar was born and raised in Westfield, New Jersey to a musical family, the daughter of Helen May (Clarke) and Charles Emory Apgar. Her father was an insurance executive, and also an amateur inventor and astronomer. She graduated from Westfield High School in 1925, knowing that she wanted to be a doctor.

 

Apgar graduated from Mount Holyoke College in 1929, where she studied zoology with minors in physiology and chemistry. In 1933, she graduated fourth in her class from Columbia University College of Physicians and Surgeons (P&S) and completed a residency in surgery at P&S in 1937. She was discouraged by Dr. Allen Whipple, the chairman of surgery at Columbia-Presbyterian Medical Center, from continuing her career as a surgeon because he had seen many women attempt to be successful surgeons and ultimately fail. He instead encouraged her to practice anesthesiology because he felt that advancements in anesthesia were needed to further advance surgery and felt that she had the “energy and ability“ to make a significant contribution. Deciding to continue her career in anesthesiology, she trained for six months under Dr. Ralph Waters at the University of Wisconsin-Madison, where he had established the first anesthesiology department in the United States. She then studied for a further six months under Dr. Ernest Rovenstine in New York at Bellevue Hospital. She received a certification as an anesthesiologist in 1937, and returned to P&S in 1938 as director of the newly formed division of anesthesia. She later received a Master’s Degree in Public Health at Johns Hopkins School of Hygiene and Public Health, graduating in 1959.

 

As the first woman to head a specialty division at Columbia-Presbyterian Medical Center (now New York-Presbyterian Hospital) and Columbia University College of Physicians and Surgeons, Apgar faced many obstacles. In conjunction with Dr. Allen Whipple, she started P&S’s anesthesia division. Apgar was placed in charge of the division’s administrative duties and was also tasked with coordinating the staffing of the division and its work throughout the hospital. Throughout much of the 1940s, she was an administrator, teacher, recruiter, coordinator and practicing physician. It was often difficult to find residents for the program, as anesthesiology had only recently been converted from a nursing specialty to a physician specialty. New anesthesiologists also faced scrutiny from other physicians, specifically surgeons, who were not used to having an anesthesia-specialized MD in the operating room. These difficulties led to issues in gaining funding and support for the division. With America’s entrance into World War II in 1941, many medical professionals enlisted in the military to help the war effort, which created a serious staffing problem for domestic hospitals, including Apgar’s division. When the war ended in 1945, interest in anesthesiology was renewed in returning physicians, and the staffing problem for Apgar’s division was quickly resolved. The specialty’s growing popularity and Apgar’s development of its residency program prompted P&S to establish it as an official department in 1949. Due to her lack of research, Apgar was not made the head of the department as was expected and the job was given to her colleague, Dr. Emmanuel Papper. Apgar was given a faculty position at P&S. In 1949, Apgar became the first woman to become a full professor at P&S, where she remained until 1959. During this time, she also did clinical and research work at the affiliated Sloane Hospital for Women, still a division of New York-Presbyterian Hospital. In 1953, she introduced the first test, called the Apgar score, to assess the health of newborn babies.

 

Between the 1930s and the 1950s, the United States infant mortality rate decreased, but the number of infant deaths within the first 24 hours after birth remained constant. Apgar noticed this trend and began to investigate methods for decreasing the infant mortality rate specifically within the first 24 hours of the infant’s life. As an obstetric anesthesiologist, Apgar was able to document trends that could distinguish healthy infants from infants in trouble. This investigation led to a standardized scoring system used to assess a newborn’s health after birth, with the result referred to as the newborn’s “Apgar score“. Each newborn is given a score of 0, 1, or 2 (a score of 2 meaning the newborn is in optimal condition, 0 being in distress) in each of the following categories: heart rate, respiration, color, muscle tone, and reflex irritability. Compiled scores for each newborn can range between 0 and 10, with 10 being the best possible condition for a newborn. The scores were to be given to a newborn one minute after birth, and additional scores could be given in five-minute increments to guide treatment if the newborn’s condition did not sufficiently improve. By the 1960s, many hospitals in the United States were using the Apgar score consistently. Entering into the 21st century the score continues to be used to provide an accepted and convenient method for reporting the status of the newborn infant immediately after birth.

 

In 1959, Apgar left Columbia and earned a Master of Public Health degree from the Johns Hopkins School of Hygiene and Public Health. From 1959 until her death in 1974, Apgar worked for the March of Dimes Foundation, serving as vice president for Medical Affairs and directing its research program to prevent and treat birth defects. As gestational age is directly related to an infant’s Apgar score, Apgar was one of the first at the March of Dimes to bring attention to the problem of premature birth, now one of the March of Dimes’ top priorities. During this time, she wrote and lectured extensively, authoring articles in popular magazines as well as research work. In 1967, Apgar became vice president and director of basic research at The National Foundation-March of Dimes.

 

During the rubella pandemic of 1964-65, Apgar became an advocate for universal vaccination to prevent mother-to-child transmission of rubella. Rubella can cause serious congenital disorders if a woman becomes infected while pregnant. Between 1964 and 1965, the United States had an estimated 12.5 million rubella cases, which led to 11,000 miscarriages or therapeutic abortions and 20,000 cases of congenital rubella syndrome. These led to 2,100 deaths in infancy, 12,000 cases of deafness, 3,580 cases of blindness due to cataracts and/or microphthalmia, and 1,800 cases of intellectual disability. In New York City alone, congenital rubella affected 1% of all babies born at that time. Apgar also promoted effective use of Rh testing, which can identify women who are at risk for transmission of maternal antibodies across the placenta where they may subsequently bind with and destroy fetal red blood cells, resulting in fetal hydrops or even miscarriage.

 

Apgar traveled thousands of miles each year to speak to widely varied audiences about the importance of early detection of birth defects and the need for more research in this area. She proved an excellent ambassador for the National Foundation, and the annual income of that organization more than doubled during her tenure there. She also served the National Foundation as Director of Basic Medical Research (1967-1968) and Vice-President for Medical Affairs (1971-1974). Her concerns for the welfare of children and families were combined with her talent for teaching in the 1972 book Is My Baby All Right?, written with Joan Beck. Apgar was also a lecturer (1965-1971) and then clinical professor (1971-1974) of pediatrics at Cornell University School of Medicine, where she taught teratology (the study of birth defects). She was the first to hold a faculty position in this new area of pediatrics. In 1973, she was appointed a lecturer in medical genetics at the Johns Hopkins School of Public Health.

 

Apgar published over sixty scientific articles and numerous shorter essays for newspapers and magazines during her career, along with her book, Is My Baby All Right? She received many awards, including honorary doctorates from the Woman’s Medical College of Pennsylvania (1964) and Mount Holyoke College (1965), the Elizabeth Blackwell Award from the American Medical Women’s Association (1966), the Distinguished Service Award from the American Society of Anesthesiologists (1966), the Alumni Gold Medal for Distinguished Achievement from Columbia University College of Physicians and Surgeons (1973), and the Ralph M. Waters Award from the American Society of Anesthesiologists (1973). In 1973 she was also elected Woman of the Year in Science by the Ladies Home Journal. Apgar was equally at home speaking to teens as she was to the movers and shakers of society. She spoke at March of Dimes Youth Conferences about teen pregnancy and congenital disorders at a time when these topics were considered taboo.

 

Throughout her career, Apgar maintained that “women are liberated from the time they leave the womb“ and that being female had not imposed significant limitations on her medical career. She avoided women’s organizations and causes, for the most part. Though she sometimes privately expressed her frustration with gender inequalities (especially in the matter of salaries), she worked around these by consistently pushing into new fields where there was room to exercise her considerable energy and abilities. Apgar never married nor had children, and died of cirrhosis on August 7, 1974, at Columbia-Presbyterian Medical Center. She is buried at Fairview Cemetery in Westfield.

 

Music was an integral part of family life, with frequent family music sessions. Apgar played the violin and her brother played piano and organ. She traveled with her violin, often playing in amateur chamber quartets wherever she happened to be. During the 1950s a friend introduced her to instrument-making, and together they made two violins, a viola, and a cello. She was an enthusiastic gardener, and enjoyed fly-fishing, golfing, and stamp collecting. In her fifties, Apgar started taking flying lessons, stating that her goal was to someday fly under New York’s George Washington Bridge.

 

Apgar has continued to earn posthumous recognition for her contributions and achievements. In 1994, she was honored by the United States Postal Service with a 20 cent Great Americans series postage stamp. In November 1995 she was inducted into the National Women’s Hall of Fame in Seneca Falls, New York. In 1999, she was designated a Women’s History Month Honoree by the National Women’s History Project. On June 7, 2018, Google celebrated Apgar’s 109th birthday with a Google Doodle.

 

Link Between Allergen in Red Meat and Heart Disease

 

The number of people with red meat allergies in the United States is unclear, but it has been estimated that it may be as high as 1% of the population in some areas. The number of people who develop blood antibodies to the red meat allergen without having full-blown symptoms is much higher — as much as 20% of the population in some areas.

 

Only in recent years has the main allergen in red meat, galactose-a-1,3-galactose, or alpha-Gal, a type of complex sugar, been identified.. Interestingly, the Lone Star tick sensitizes people to this allergen when it bites them. That is why red meat allergies tend to be more common where these ticks are more prevalent, such as the Southeastern United States, but also extending to other areas, including Long Island, New York. It has been suspected for some time that allergens can trigger certain immunological changes that might be associated with plaque buildup and artery blockages, but no one had identified a specific substance that is responsible for this effect. Now, according to an article published in Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB; 14 June 2018), results suggest a link of sensitivity to alpha-Gal to the buildup of plaque in the arteries of the heart. While high saturated fat levels in red meat have long been known to contribute to heart disease for people in general, this new finding suggests that a subgroup of the population may be at heightened risk for a different reason – a food allergen.

 

In the current study, it was shown for the first time that a specific blood marker for red meat allergy was associated with higher levels of arterial plaque, or fatty deposits on the inner lining of the arteries. The blood marker they identified is a type of antibody (immunoglobulin or IgE) that is specific to the alpha-Gal allergen. To identify this blood marker, the authors analyzed blood samples from 118 adults and detected antibodies to alpha-Gal in 26% of the samples, indicating sensitivity to red meat. Using an imaging procedure, it was found that the quantity of plaque was 30% higher in the alpha-Gal sensitized patients than in the non-sensitized patients. These plaques, a hallmark of atherosclerosis (hardening of the arteries), also tended to be more structurally unstable, which means that they have an increased likelihood of causing heart attack and stroke.

 

According to the authors, that since the evidence for a link between red meat allergens and coronary artery disease is still preliminary, they plan to conduct detailed animal and human studies to confirm their initial findings. Currently, the only treatment for red meat allergy once it is diagnosed is strict avoidance of red meat.

 

An “Old” Marketed Drug for T-Cell Lymphoma Restores Hearing in Mice

 

On October 6, 2006, the FDA granted regular approval to vorinostat (Zolinza(R); Merck & Co., Inc., for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease on or following two systemic therapies.

 

According to an article published online in Cell (28 June 2018), a novel drug therapy that partially restored hearing in mice, might shed light on molecular mechanisms of inherited form of progressive human deafness known as deafness, autosomal dominant 27 (DFNA27). The seed for this study was planted a decade ago, when the genomes of members of an extended family, dubbed LMG2, were analyzed. Deafness was genetically dominant in the LMG2 family, meaning that a child needs to inherit only one copy of the defective gene from a parent to have progressive hearing loss. The investigators then localized the deafness-causing mutation to a region on chromosome four called DFNA27, which includes a dozen or so genes. However, the precise location of the mutation eluded the research team.

 

A crucial clue to explain the DFNA27 form of progressive deafness arose from later studies of the mouse gene called Rest (RE1 Silencing Transcription Factor) when it was discovered that mouse Rest is regulated through an unusual mechanism in the sensory cells of the inner ear, and this regulation is critical for hearing in mice. Because the human counterpart of the mouse Rest gene is located in the DFNA27 region, the authors decided to rexamine the mystery of DFNA27 progressive deafness.

 

As a backgrounder, the coding sequence of a protein is generated from a gene by stitching together segments called exons while editing out the intervening segments. The resulting molecule serves as the template for a specific protein. Most previous studies had missed exon 4 in the Rest gene because this small exon is not edited into the Rest mRNA in most cells. The normal function of the REST protein is to shut off genes that need to be active only in a very few cell types. When the authors deleted exon 4 of Rest in mice, inner ear hair cells died, and mice became deaf. Many genes that should have been active were shut off in hair cells prior to their death. The team then pinpointed the deafness mutation in the LMG2 family and discovered that the mutation lies near exon 4, altering the boundaries of exon 4, and interferes with the inactivation of REST in hair cells. The authors then used Banfi’s exon 4-deficient mice as a model for DFNA27 deafness. Since REST suppresses gene expression through a process called histone deacetylation, they wanted to see if blocking this process could reduce hearing loss. Using small-molecule drug vorinostat, a HDAC inhibitor, it was possible to rescue the hearing of these mice.

 

According to the authors, these results demonstrate the value of studying the molecular mechanisms that underlie inherited forms of deafness, and that by following these genetic leads, it is possible to find novel and unexpected pathways that can, in cases such as this one, uncover unexpected potential treatment strategies in people.

 

Device Approved to Treat Breathing Difficulty in Severe Emphysema

 

The Centers for Disease Control and Prevention estimates that 3.5 million American adults have been diagnosed with emphysema. Emphysema, including severe emphysema, is a type of chronic obstructive pulmonary disease (COPD) due to damage to the air sacs (alveoli) in the lungs. Lung damage from emphysema is irreversible. The damaged alveoli can cause used air to become trapped in the lungs during exhalation. This can cause the diseased parts of the lung to get larger and put pressure on the healthy part of the lung, which makes it difficult to breathe. As a result, the body may not get the oxygen it needs. Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These options include lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients.

 

The FDA has approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema. Using a flexible bronchoscope, the Zephyr Valves, similar in size to pencil erasers, are placed into the diseased areas of the lung airways during a hospital-based procedure. The design of the device is intended to prevent air from entering the damaged parts of the lung and allow trapped air and fluids to escape. During inhalation, the valves close, preventing air from entering the damaged part of the lung and during exhalation, the valves open, letting out trapped air, which is intended to relieve pressure. The FDA reviewed data from a multi-center study of 190 patients with severe emphysema. In this study, 128 patients were treated with Zephyr Valves and medical management according to current clinical guidelines, including medications (bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance medications) and pulmonary rehabilitation, while 62 patients (the control group) received medical management only. Results of treatment were measured by how many patients in each arm of the study had at least a 15% improvement in pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation). At one year, 47.7% of patients treated with Zephyr Valves experienced at least a 15% improvement in their pulmonary function scores, compared with 16.8% of patients in the control group. Adverse events observed in the study include death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain.

 

The Zephyr Valve device is contraindicated for patients with active lung infections; those who are allergic to nitinol, nickel, titanium or silicone; active smokers and those who are not able to tolerate the bronchoscopic procedure. Patients who have had major lung procedures, heart disease, large bubbles of air trapped in the lung or who have not responded to other treatments should talk with their providers to determine if the Zephyr Valve device is appropriate for them.

 

The Zephyr Valve was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

 

The FDA reviewed the Zephyr Valve device through the premarket approval review pathway, a regulatory pathway for the highest risk class of devices.

 

The FDA granted approval of the Zephyr Valve device to Pulmonx Inc.

 

Tilapia Florentine with Green and Red Grapes

We could not believe how good this recipe turned out. It is healthy and absolutely delicious. In just a few seconds, Jules gave my new recipe a thumbs up, five stars. We’re making it again, for a house guest. ©Joyce Hays, Target Health Inc.

 

If you don’t have tilapia in your neighborhood, use any white fish, light in texture like Dover or fillet of sole, etc. but check the sustainable fish list, created by Monterrey Bay Aquarium: http://www.seafoodwatch.org/seafood-recommendations

Farmed tilapia are okay to buy. ©Joyce Hays, Target Health Inc.

 

Not only is my recipe really tasty but the presentation is colorful and appealing. A big plus for tilapia, it’s on all the responsible lists of sustainable fish. When you check these lists, take note, fish are often okay to eat, based on where on the planet they come from. Also, some fish go by more than one name, for example Mahi Mahi are also called Dolphinfish. ©Joyce Hays, Target Health Inc.

 

Ingredients

1 onion, chopped

1/2 pound tilapia fillets, don’t worry if it goes over 1/2 pound

10 green seedless grapes cut in half, set aside

10 red seedless grapes, cut in half, set aside

3 anchovy fillets, mashed with 3 cloves garlic

12 more fresh garlic cloves, sliced

1 cup fresh Italian-leaf parsley, chopped

1 cup fresh dill, chopped

1/4 cup Sambuca liqueur

Zest of 1 lemon

Juice of 1 lemon

1 teaspoon curry powder

1 teaspoon turmeric

1 teaspoon cardamom

1 heaping Tablespoon sesame seeds, toasted

2 large shallots, chopped

2 scallions, chopped (save some green for garnish)

1 Tablespoon olive oil

1 and 1/2 or 2 pounds baby spinach. Save one uncooked leaf for each person to be served.

Mix together 1/4 cup sharp cheddar (grated by hand) and ? cup feta cheese, grated by hand, then set aside

 

I love experimenting with new combinations and have been waiting for the right time to add Sambuca (licorice flavor) liqueur. If you read the recipes in our newsletter, you know I’m also having great results by using mashed anchovies and fresh garlic in many recipes, instead of salt. I have also begun trying out crickets and cricket products in recipes as a way of introducing a protein that leaves basically no carbon footprint. Of all the cultures that eat insects as a regular part of their diet, the favorite are the crickets. When I was much younger, and my favorite grandmother turned 99 (she lived to be 101), I baked her a cake with 99 candles and gave her a gift of chocolate covered ants. She loved them and passed the box around to all guests. It was like eating a chocolate covered rice crispy cake – delicious! ©Joyce Hays, Target Health Inc.

 

To Cook the Tilapia

1. Cut each fillet in half, lengthwise

2. Dip each fish fillet (both sides), first in: 1 egg beaten with 1 Tablespoon almond or coconut milk.

3. Then cover both sides of the fish with the following mixture: 1/2 cup Panko mixed with 1/2 cup parmesan & 1 heaping Tablespoon cricket flour

 

About to mix the Panko, parmesan and cricket flour. ©Joyce Hays, Target Health Inc.

 

Tilapia has been rolled in the egg mixture, now the Panko/Cricket crumb mixture, before cooking. ©Joyce Hays, Target Health Inc.

 

4. Cook in skillet with 1 Tablespoon extra-virgin olive oil, no more than 1 minute on each side.

 

Cooking the tilapia. ©Joyce Hays, Target Health Inc.

 

5. Put fish on paper toweling and set aside.

 

Tilapia is done and draining on paper toweling. ©Joyce Hays, Target Health Inc.

  

Directions for Spinach Sauce

Preheat oven to 375 degrees

Oil a baking dish that can go from oven to table.

Do all your chopping, grating, slicing, mashing, zesting, etc. before anything else.

 

Cheese has been grated and/or crumbled and set aside. ©Joyce Hays, Target Health Inc.

 

Getting ready to mash the anchovies and garlic. ©Joyce Hays, Target Health Inc.

 

Cut grapes in half and set aside in a handy measuring cup. ©Joyce Hays, Target Health Inc.

 

Chopping everything at once. The lavender section are the shallots. ©Joyce Hays, Target Health Inc.

 

6. Even with baby spinach, you’ve got to do a lot of rinsing. So, rinse the baby spinach two times and let drain, two times. Paper towel dry before cooking. For all other spinach, rinse three times, draining each time as well.

 

Save a few uncooked baby spinach leaves for serving the fish on, later. ©Joyce Hays, Target Health Inc.

 

7. In a skillet over medium-high heat, add 1 Tablespoon extra-virgin olive oil and saut? onions, garlic, mashed anchovy/garlic, scallions, shallots in oil, until onions and garlic become golden.

 

Cooking everything in step #5. ©Joyce Hays, Target Health Inc.

 

8. Reduce heat to medium and add the lemon zest, lemon juice, parsley, dill and all seasoning and spices; add the toasted sesame seeds.

 

If you wish, you can zest the lemon directly into the skillet, or elsewhere. ©Joyce Hays, Target Health Inc.

 

Adding lemon zest and lemon juice to the skillet. ©Joyce Hays, Target Health Inc.

 

Adding all chopped herbs to the skillet. ©Joyce Hays, Target Health Inc.

 

Adding all spices to the skillet. ©Joyce Hays, Target Health Inc.

 

9. Now, add the spinach, cooking until wilted over medium to low heat. Then add the sambuca and stir in well. Make sure the sauce is nicely heated.

 

Add the fresh spinach. It looks like a lot but will wilt down in a matter of minutes. ©Joyce Hays, Target Health Inc.

 

Here the spinach has wilted down and has been well combined with the other ingredients. ©Joyce Hays, Target Health Inc.

 

10. Add all the red and green grapes and stir in for 30 seconds.

 

Stir the grapes into the spinach mixture. ©Joyce Hays, Target Health Inc.

 

11. Finally, distribute the crumbled or grated feta & cheddar, over the spinach mixture

 

Cheese mixture has been evenly distributed over the mixture. ©Joyce Hays, Target Health Inc.

 

12. Add the tilapia over the cheese in one layer and bake in oven for 10 minutes, or until the cheese has melted. Bring to table, serve and enjoy!

 

To serve: On each plate, place 1 or 2 (depending on their size) raw spinach leaves. Onto the spinach leaves put one serving of the fish & spinach sauce. For garnish, add some chopped scallion and 1 red grape half and 1 green grape half.

 

Another way to serve, without using the oven: Keep the spinach sauce separate from the skillet cooked fish and add both cheeses to the skillet combining well, into the sauce. Put the raw spinach on each plate. On each leaf place 1 tilapia fillet. Spoon the spinach sauce over each fillet and then add the scallion/grape garnish.

 

Best Choices to Substitute for Tilapia in the Recipe 

Bronzini

Cod

Mahi Mahi or Dolphinfish (US handlines)

Seabass (farmed)

Tilapia (Canada, Ecuador, Peru & US)

Trout: Rainbow/Steelhead (US farmed)

Tuna: Albacore (trolls, pole and lines)

Haddock

Pollock (Canada longlines, gillnets & US)

Flounder (farmed)

Haddock

Turbot

Seabass (farmed)

Scrod

Dover sole

 

Everything disappeared fast. This baking dish was empty in no time. Yum! ©Joyce Hays, Target Health Inc.

 

This Louis Jadot, Pouilly-Fuisse went well with the Tilapia Florentine . ©Joyce Hays, Target Health Inc.

 

Have a great week everyone!

Bon Appetit!