Discover all the latest about our products, technology, and Target Health culture on our official blog.
April 6, 2020Target Healthy Eating
1. In a separate bowl, whisk the eggs then set aside.
2. Drain the liquid from the tuna cans. If you are using tuna packed in water, reserve a Tablespoon of the tuna water, and add a teaspoon of olive oil to the tuna mixture in the next step.
3. In a large bowl, mix together all the ingredients, except for the whisked eggs. Taste the mixture before adding the eggs to see if it needs more seasoning to your taste. Finally, add the whisked eggs and mix, so all the ingredients are well combined.
4. Divide the mixture into 4 to 6 parts, depending on how large you want each patty to be. With each part, form into a ball and then flatten into a patty. Place all the patties onto a tray, lined with wax paper. Put into refrigerator for an hour. Chilling, helps the patties stay together when you cook them.
5. In a skillet, heat the olive oil over a medium high flame. Gently place the patties in the pan, and cook until nicely browned, 3-4 minutes on each side.
Serve with wedges of lemon and your favorite garden salad, or simply slices of tomato and carrot sticks, with a side dish of lentils, or rice or baked potato.
From Our Table to Yours
Have a Great Week Everyone!
April 6, 2020Regulatory
As part of the response to COVID-19 pandemic, the FDA is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus. The products can be administered to individuals diagnosed with COVID-19. There are some limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the COVID-19 illness. This is why evaluation of these therapies in the context of a clinical trial and expanded access program is so important.
Based on prior experience with respiratory viruses and on data that have emerged from China, these products have the potential to lessen the severity or shorten the length of illness caused by COVID-19. The FDA is facilitating access to convalescent plasma for treating COVID-19 using multiple pathways. The FDA's initial effort was focused on facilitating access to convalescent plasma for the treatment of COVID-19 disease through an emergency investigational new drug application (eIND) process. The FDA has provided information to help health care providers submit these applications to treat individual patients. The agency also is facilitating the conduct of well-controlled clinical trials at academic institutions to rigorously evaluate the safety and efficacy of convalescent plasma.
The FDA has led an effort, working collaboratively with our industry, academic, and government partners to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place. This will allow for a simplified process for providers that will help to ensure patient safety, while also allowing for the collection of needed information about product efficacy. In this partnership, the Mayo Clinic will serve as the lead institution for the program and the American Red Cross will help collect plasma and distribute it for use in patients across the country. The program was developed with funding from the Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services' Office of the Assistant Secretary of Preparedness and Response. The FDA anticipates that this collaborative effort will be able to move thousands of units of plasma to the patients who need them in the coming weeks.
The FDA is also working with industry and its government partners to accelerate the development and availability of hyperimmune globulin for investigation for the potential treatment COVID-19. Hyperimmune globulin is a biological product manufactured from convalescent plasma. The FDA is helping to coordinate a study of hyperimmune globulin that will be conducted by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, as well as coordinating other efforts in this area. The FDA continues to provide advice, guidance, and technical assistance to help expedite the development of these products and intends to use regulatory flexibility in making these products and other critical medical countermeasures available to prevent and treat COVID-19.
People who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating plasma, which could potentially help save the lives of up to four patients. Those willing to donate are urged to visit the American Red Cross website at www.redcrossblood.org/plasma4covid or contact their local blood donor or plasma collection center.
April 6, 2020Rare Diseases
According to a study in the Journal of Experimental Medicine (31 March 2020), a second gene has been discovered that causes melorheostosis, a rare group of conditions involving an often painful and disfiguring overgrowth of bone tissue. The gene, SMAD3, is part of a pathway that regulates cell development and growth. The authors are now working to develop an animal model with a mutant version of SMAD3 to test potential treatments for the condition.
Melorheostosis affects about 1 in 1 million people and its causes have long been unknown. DNA tests of blood and skin could not identify a mutation. The key to finding the gene was to biopsy the affected bone directly and compare it to unaffected bone. Earlier, the authors used this method to discover the gene for dripping candle wax bone disease, a form of melorheostosis in which excess bone growth appears to drip from the bone surface like hot wax. In that study, mutations in the gene MAP2K1 accounted for eight cases of the disease among 15 patients.
In the current study, the authors scanned the exome -- the part of the genome that codes for proteins -- and found mutations in the affected bone. These mutations occurred during the patient's lifetime rather than being inherited from parents and are not present in all the cells of the body. The authors found SMAD3 mutations in four of the patients who did not have mutations in MAP2K1. SMAD3 is involved in a pathway crucial for skeletal development both before and after birth. The SMAD3 mutations increase the maturation of bone-forming cells and are involved in a cellular pathway distinct from the MAPK2K1 pathway.
April 6, 2020Neurology
A study published in Neuron (2 April 2020) offers clues to why autism spectrum disorder (ASD) is more common in boys than in girls. The study found that a single amino acid change in the NLGN4 gene, which has been linked to autism symptoms, may drive this difference in some cases. The study compared two NLGN4 genes, (one on the X chromosome and one on the Y chromosome), which are important for establishing and maintaining synapses, the communication points between neurons.
Every cell in our body contains two sex chromosomes. Females have two X chromosomes; males have one X and one Y chromosome. Until now, it was assumed that the NLGN4X and NLGN4Y genes, which encode proteins that are 97% identical, functioned equally well in neurons. However, by using a variety of advanced technology including biochemistry, molecular biology, and imaging tools, the authors discovered that the proteins encoded by these genes display different functions. The NLGN4Y protein is less able to move to the cell surface in brain cells and is therefore unable to assemble and maintain synapses, making it difficult for neurons to send signals to one another. When the authors fixed the error in cells in a dish (in vitro), they restored much of its correct function.
According to the authors, there is a significant need to look at NLGN4X and NLGN4Y more carefully. The reason is that mutations in NLGN4X can lead to widespread and potentially very severe effects in brain function, and the role of NLGNY is still unclear. The authors discovered that the problems with NLGN4Y were due to a single amino acid. The authors also discovered that the region surrounding that amino acid in NLGN4X is sensitive to mutations in the human population. There are a cluster of variants found in this region in people with ASD and intellectual disability and these mutations result in a deficit in function for NLGN4X that is indistinguishable from NLGN4Y.
In females, when one of the NLGN4X genes has a mutation, the other one can often compensate. However, in males, diseases can occur when there is a mutation in NLGN4X because there is no compensation from NLGN4Y.
The current study suggests that if there is a mutation in NLGN4X, NLGN4Y is not able to take over, because it is a functionally different protein. If the mutations occur in regions of NLGN4X that affect the protein levels, that may result in autism-related symptoms including intellectual deficits. The inability of NLGN4Y to compensate for mutations in NLGN4X may help explain why males, who only have one X chromosome, tend to have a greater incidence of NLGN4X-associated ASD than females.
TA Nguyen et al. A cluster of autism-associated variants on X-linked NLGN4X functionally resemble NLGN4Y. Neuron. April 2, 2020
April 6, 2020History of Medicine
Ilya Ilyich Mechnikov (Elie Metchnikoff; 1845 - 1916) was a Russian zoologist best known for his pioneering research in immunology. In particular, he is credited with the discovery of phagocytes (macrophages) in 1882. This discovery turned out to be the major defense mechanism in innate immunity. Mechnikov and Paul Ehrlich were jointly awarded the 1908 Nobel Prize in Physiology or Medicine "in recognition of their work on immunity". He is also credited by some sources with coining the term gerontology in 1903, for the emerging study of aging and longevity. Mechnikov also established the concept of cell-mediated immunity, while Ehrlich established the concept of humoral immunity. Their works are regarded as the foundation of the science of immunology. In immunology, he is given an epithet the "father of natural immunity".
Mechnikov was born in the village Ivanovka, Kharkov Governorate, now Dvorichna Raion, Ukraine. He was the youngest of five children of Ilya Ivanovich Mechnikov, a Russian officer of the Imperial Guard. His mother, Emilia Lvovna (Nevakhovich), the daughter of the Jewish writer Leo Nevakhovich, largely influenced him on his education, especially in science. His elder brother Lev became a prominent geographer and sociologist.
Mechnikov entered Kharkiv Lycee in 1856 where he developed his interest in biology. Convinced by his mother to study natural sciences instead of medicine, in 1862 he tried to study biology at the University of Wurzburg, but the German academic session would not start by the end of the year. So he enrolled at Kharkiv University for natural sciences, completing his four-year degree in two years. In 1864 he went to Germany to study marine fauna on the small North Sea island of Heligoland. He was advised by the botanist Ferdinand Cohn to work with Rudolf Leuckart at the University of Giessen. It was in Leuckart's laboratory that he made his first scientific discovery of alternation of generations (sexual and asexual) in nematodes and then at Munich Academy. In 1865, while at Giessen, he discovered intracellular digestion in flatworm, and this study influenced his later works. Moving to Naples the next year he worked on a doctoral thesis on the embryonic development of the cuttle-fish Sepiola and the crustacean Nebalia.
A cholera epidemic in the autumn of 1865 made him move to the University of Gottingen, where he worked briefly with W. M. Keferstein and Jakob Henle. In 1867 he returned to Russia to get his doctorate with Alexander Kovalevsky from the University of St. Petersburg. Together they won the Karl Ernst von Baer prize for their theses on the development of germ layers in invertebrate embryos. Mechnikov was appointed docent at the newly established Imperial Novorossiya University (now Odessa University). Only twenty-two years of age, he was younger than his students. In 1868 he transferred to the University of St. Petersburg. In 1870 he returned to Odessa to take up the appointment of Titular Professor of Zoology and Comparative Anatomy.
In 1882, Mechnikov resigned from Odessa University due to political turmoil after the assassination of Alexander II. He went to Sicily to set up his private laboratory in Messina. He returned to Odessa as director of an institute set up to carry out Louis Pasteur's vaccine against rabies; due to some difficulties, he left in 1888 and went to Paris to seek Pasteur's advice. Pasteur gave him an appointment at the Pasteur Institute, where he remained for the rest of his life.
Mechnikov became interested in the study of microbes, and especially the immune system. At Messina he discovered phagocytosis after experimenting on the larvae of starfish. In 1882 he first demonstrated the process when he inserted small citrus thorns into starfish larvae, then found unusual cells surrounding the thorns. He realized that in animals which have blood, the white blood cells gather at the site of inflammation, and he hypothesized that this could be the process by which bacteria were attacked and killed by the white blood cells. He discussed his hypothesis with Carl Friedrich Wilhelm Claus, Professor of Zoology at the University of Vienna, who suggested to him the term phagocyte for a cell which can surround and kill pathogens. He delivered his findings at Odessa University in 1883.
Mechnikov's theory, that certain white blood cells could engulf and destroy harmful bodies such as bacteria, met with skepticism from leading specialists including Louis Pasteur, Behring and others. At the time, most bacteriologists believed that white blood cells ingested pathogens and then spread them further through the body. His major supporter was Rudolf Virchow, who published his research in his Archiv fur pathologische Anatomie und Physiologie und fur klinische Medizin (now called the Virchows Archiv). The discovery of these phagocytes ultimately won him the Nobel Prize in 1908. Mechnikov also worked with ?mile Roux on calomel (mercurous chloride) in ointment form in an attempt to prevent people from contracting the sexually transmitted disease syphilis.
In 1887, Mechnikov observed that leukocytes isolated from the blood of various animals were attracted towards certain bacteria. The first studies of leukocyte killing in the presence of specific antiserum were performed by Joseph Denys and Joseph Leclef, followed by Leon Marchand and Mennes between 1895 and 1898. Almoth E. Wright was the first to quantify this phenomenon and strongly advocated its potential therapeutic importance. The so-called resolution of the humoralist and cellularist positions by showing their respective roles in the setting of enhanced killing in the presence of opsonins was popularized by Wright after 1903, although Metchnikoff acknowledged the stimulatory capacity of immunosentisitized serum on phagotic function in the case of acquired immunity.
This attraction was soon proposed to be due to soluble elements released by the bacteria. Some 85 years after this seminal observation, laboratory studies showed that these elements were low molecular weight (between 150 and 1500 Dalton (unit)s) N-formylated oligopeptides, including the most prominent member of this group, N-Formylmethionine-leucyl-phenylalanine, that are made by a variety of replicating gram positive bacteria and gram negative bacteria. Mechnikov's early observation, then, was the foundation for studies that defined a critical mechanism by which bacteria attract leukocytes to initiate and direct the innate immune response of acute inflammation to sites of host invasion by pathogens.
Mechnikov also developed a theory that aging is caused by toxic bacteria in the gut and that lactic acid could prolong life. Based on this theory, he drank sour milk every day. He wrote The Prolongation of Life: Optimistic Studies, in which he espoused the potential life-lengthening properties of lactic acid bacteria (Lactobacillus delbrueckii subsp. bulgaricus). He attributed the longevity of Bulgarian peasants to their yogurt consumption.
Mechnikov died in 1916 in Paris from heart failure. According to his will, his body was used for medical research and afterwards cremated in Pere Lachaise Cemetery crematorium. His cinerary urn has been placed in the Pasteur Institute library.
Mechnikov was greatly influenced by Charles Darwin's theory of evolution. He first read Fritz Muller's Fur Darwin in Giessen. From this he became a supporter of natural selection and Ernst Haeckel's biogenetic law. His scientific works and theories were inspired by Darwinism.
Awards and Recognitions
Mechnikov with Alexander Kovalevsky won the Karl Ernst von Baer prize in 1867 based on their doctoral research. He shared the Nobel Prize in Physiology or Medicine in 1908 with Paul Ehrlich. He was awarded honorary degree from the University of Cambridge in Cambridge, UK, and the Copley Medal of the Royal Society in 1906. He was given honorary memberships in the Academy of Medicine in Paris and the Academy of Sciences and Medicine in St. Petersburg. The Leningrad Medical Institute of Hygiene and Sanitation, founded in 1911 was merged with Saint Petersburg State Medical Academy of Postgraduate Studies in 2011. This became the North-Western State Medical University named after Mechnikov.
April 6, 2020Quiz
1) _____, also known as pink eye, is inflammation of the outermost layer of the white part of the eye and the inner surface of the eyelid. It makes the eye appear pink or reddish. Pain, burning, scratchiness, or itchiness may also occur. The affected eye may have increased tears or be stuck shut in the morning. Swelling of the white part of the eye may also occur. Conjunctivitis can affect one or both eyes.
The most common infectious causes are 2) _____ followed by bacterial. The viral infection may occur along with other symptoms of a common cold. Both viral and bacterial cases are easily spread between people. Allergies to pollen or animal hair are also a common cause. Diagnosis is often based on signs and symptoms. Occasionally, a sample of the discharge is sent for culture.
Prevention is partly by handwashing. Treatment depends on the underlying cause. In the majority of viral cases, there is no specific treatment. Most cases due to a bacterial infection also resolve without treatment; however, antibiotics can shorten the illness. People who wear contact lenses and those whose infection is caused by gonorrhea or chlamydia should be treated. Allergic cases can be treated with antihistamines or mast cell inhibitor drops.
Pink Eye, or conjunctivitis, is often a symptom of COVID-19. Besides causing COVID-19, the new coronavirus can also lead to 3) ___ ___, and Chinese researchers say the virus may be spread by tears. In a study of 38 patients with COVID-19, twelve (12) also had pink eye. In two patients, the coronavirus was present in both nasal and eye fluids. According to the authors, some COVID-19 patients have ocular symptoms, and maybe novel coronaviruses are present in the conjunctival secretions of patients with COVID-19. Since the 4) _____ is a thin, transparent layer of tissue that lines the inner eyelid and covers part of the white of the eye, the coronavirus may invade it in patients with severe 5) _____ pneumonia. That means the virus can be spread if someone rubs an infected eye and then touches someone else - or even during an eye examination. According to an article published in JAMA Ophthalmology (31 March 2020), the more severe a patient's COVID-19 is, the more likely it is that he or she will also have pink eye. Given these findings, the authors recommend that doctors and nurses treating patients with COVID-19 should wear protective glasses as well as other protective clothing, caps and gloves. Thus, people should take steps to prevent pink eye, including avoiding touching their eyes and face, and using 6) _____ instead of 7) _____ lenses during the coronavirus outbreak. Clearly, this is a warning to people that the conjunctiva can be a source of spreading 8) _____.
Currently, the guidelines from the American Academy of 9) _____ recommend regular eye exams not be performed during the pandemic. Of course, any 10) _____ that can affect vision still need to be treated immediately.
Sources: Wikipedia; webmd.com
ANSWERS: 1) Conjunctivitis; 2) viral; 3) pink eye; 4) conjuctiva; 5) COVID-19; 6) glasses; 7) contact; 8) infection; 9) Ophthalmology; 10) emergencies
April 6, 2020What's New
This is what was sent to all of our staff at Target Health, as well as to our friends and colleagues on LinkedIn.
TO THE BEST TEAM IN THE INDUSTRY, THANK YOU AND BE SAFE
Target Health has not skipped a beat during this most difficult time for all of us, both at home and around the world. Because we are an international company with employees, families, colleagues and friends from all over the planet, clearly, COVID-19 has impacted all of us, including our dear friends at dMed in China. Everyone should know that dMed has been involved in several local COVID-19 studies in China. Bravo!
We are also honored that Target Health has been chosen to help run 2 COVID-19 studies in the US. We have had discussions with several of our clients and academic researchers who have several very creative ideas on how to deal with very sick patients during the current pandemic.
Fortunately, each department has been able to work remotely and so far, modern technology has served us well. Therefore, we are up and running on all cylinders and full speed ahead.
Please all be safe, and reach out to friends and colleagues so as not to be alone during this most difficult time. We will get through this together.
For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Dr. Jules T. Mitchel, Editor
March 30, 2020Target Healthy Eating
1 and 1/2 cups sugar
4 Tablespoons cold butter
1 and 1/2 cups flour (I've used chickpea flour, almond flour, rice flour, reg flour)
2 teaspoons baking powder
1 teaspoon vanilla
1 cup milk
1 Tablespoon lemon juice
1 Tablespoon sugar
1/2 teaspoon ground cinnamon
2 Granny Smith (green) apples
Cool whip for serving, or whipped cream or vanilla ice cream
Chopped nuts (optional)
First dry ingredients:
From Our Table to Yours
Have a Great Week Everyone!
March 30, 2020Regulatory
The FDA has announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
March 30, 2020Coronavirus
According to an article published in The New England Journal of Medicine (17 March 2020), the virus that causes coronavirus disease 2019 (COVID-19) is stable for several hours to days in aerosols and on surfaces. The authors found that the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detectable in aerosols for up to three hours, up to four hours on copper, up to 24 hours on cardboard and up to two to three days on plastic and stainless steel. The results provide key information about the stability of SARS-CoV-2, which causes COVID-19 disease, and suggests that people may acquire the virus through the air and after touching contaminated objects. The study information was widely shared during the past two weeks after the authors placed the contents on a preprint server to quickly share their data with colleagues.
For the study, the authors from from the National Institute of Allergy and Infectious Diseases' Montana facility at Rocky Mountain Laboratories, compared how the environment affects SARS-CoV-2 and SARS-CoV-1, which causes SARS. SARS-CoV-1, like its successor now circulating across the globe, emerged from China and infected more than 8,000 people in 2002 and 2003. SARS-CoV-1 was eradicated by intensive contact tracing and case isolation measures and no cases have been detected since 2004. SARS-CoV-1 is the human coronavirus most closely related to SARS-CoV-2. In the stability study the two viruses behaved similarly, which unfortunately fails to explain why COVID-19 has become a much larger outbreak.
The current study attempted to mimic virus being deposited from an infected person onto everyday surfaces in a household or hospital setting, such as through coughing or touching objects. The authors then investigated how long the virus remained infectious on these surfaces.
The authors highlighted additional observations from their study:
-- If the viability of the two coronaviruses is similar, why is SARS-CoV-2 resulting in more cases? Emerging evidence suggests that people infected with SARS-CoV-2 might be spreading virus without recognizing, or prior to recognizing, symptoms. This would make disease control measures that were effective against SARS-CoV-1 less effective against its successor.
-- In contrast to SARS-CoV-1, most secondary cases of virus transmission of SARS-CoV-2 appear to be occurring in community settings rather than healthcare settings. However, healthcare settings are also vulnerable to the introduction and spread of SARS-CoV-2, and the stability of SARS-CoV-2 in aerosols and on surfaces likely contributes to transmission of the virus in healthcare settings.
The findings affirm the guidance from public health professionals to use precautions similar to those for influenza and other respiratory viruses to prevent the spread of SARS-CoV-2:
1. Avoid close contact with people who are sick.
2. Avoid touching your eyes, nose, and mouth.
3. Stay home when you are sick.
4. Cover your cough or sneeze with a tissue, then throw the tissue in the trash.
5. Clean and disinfect frequently touched objects and surfaces using a regular household
cleaning spray or wipe.