Electronically Signing Informed Consent Forms

 

We were asked a few months ago by a colleague from a device company if we could provide the capability for study subjects to sign the informed consent form online, as a fully integrated feature of Target e*CRF®. Since we were already collecting ePRO data fully integrated with Target e*CRF, and the clinical sites were managing the online registration process for the study subjects, we said “why not.“ We figured that since the PI’s were already electronically signing the eCRFs and online SAE reports, it should not be a very big deal. So we assembled our senior eCRF design team and solved the problem. It basically was about the workflow, not the technology.

 

For the skeptics, we also allow the tracking of manual signatures on a piece of paper for those who like the touch and feel of trees. However, now with online access, study subjects will always sign and download the right version of the informed consent form, and most importantly, CRAs do not have to show up at the clinical sites, just to verify the signature process.

 

We plan to present our solution to FDA in the very near future.

 

Morning in New York City – View From the 24th Floor Offices of Target Health Inc.

 

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Morning From the 24th Floor Offices of Target Health, 2015 ©Target Health Inc.

 

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

 

QUIZ

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Turning Back the Aging (Telomeres) Clock

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Hands of elderly person (stock image). Skin cells with telomeres lengthened by a new procedure were able to divide up to 40 more times than untreated cells. The research may point to new ways to treat diseases caused by shortened telomeres.

 

According to scientists at the Stanford University School of Medicine, a new procedure can quickly and efficiently increase the length of human telomeres, the protective caps on the ends of 1) ___ that are linked to aging and disease. Treated cells behave as if they are much younger than untreated cells, multiplying with abandon in the laboratory dish rather than stagnating or 2) ___. The procedure, which involves the use of a modified type of RNA, will improve the ability of researchers to generate large numbers of cells for study or drug development, the scientists say. Skin cells with telomeres lengthened by the procedure were able to divide up to 40 more times than untreated cells. The research may point to new ways to treat diseases caused by shortened 3) ___.

 

Telomeres are the protective caps on the ends of the strands of DNA called chromosomes, which house our genomes. In young humans, telomeres are about 8,000-10,000 nucleotides long. They shorten with each cell division, however, and when they reach a critical length the 4) ___ stops dividing or dies. This internal “clock“ makes it difficult to keep most cells growing in a laboratory for more than a few cell doublings. “Now we have found a way to lengthen human telomeres by as much as 1,000 nucleotides, turning back the internal clock in these cells by the equivalent of many years of human life,“ said Helen Blau, PhD, professor of microbiology and immunology at Stanford and director of the university’s Baxter Laboratory for Stem Cell Biology. “This greatly increases the number of cells available for studies such as 5) ___ testing or disease modeling.“ A paper describing the research was published January 2015, in the FASEB Journal. Blau, who also holds the Donald E. and Delia B. Baxter Professorship, is the senior author. Postdoctoral scholar John Ramunas, PhD, of Stanford shares lead authorship with Eduard Yakubov, PhD, of the Houston Methodist Research Institute.

 

The researchers used modified messenger RNA to extend the telomeres. 6) ___ carries instructions from genes in the DNA to the cell’s protein-making factories. The RNA used in this experiment contained the coding sequence for TERT, the active component of a naturally occurring enzyme called telomerase. Telomerase is expressed by stem cells, including those that give rise to sperm and egg cells, to ensure that the telomeres of these cells stay in tip-top shape for the next generation. Most other types of cells, however, express very low levels of telomerase. The newly developed technique has an important advantage over other potential methods: It’s temporary. The modified RNA is designed to reduce the cell’s 7) ___ response to the treatment and allow the TERT-encoding message to stick around a bit longer than an unmodified message would. But it dissipates and is gone within about 48 hours. After that time, the newly lengthened telomeres begin to progressively shorten again with each cell division.

 

The transient effect is somewhat like tapping the gas pedal in one of a fleet of cars coasting slowly to a stop. The car with the extra surge of energy will go farther than its peers, but it will still come to an eventual halt when its forward momentum is spent. On a biological level, this means the treated cells don’t go on to divide indefinitely, which would make them too dangerous to use as a potential therapy in humans because of the risk of cancer. The researchers found that as few as three applications of the modified RNA over a period of a few days could significantly increase the length of the telomeres in cultured human muscle and skin cells. A 1,000-nucleotide addition represents a more than 10 percent increase in the length of the telomeres. These cells divided many more times in the culture dish than did untreated cells: about 28 more times for the skin cells, and about three more times for the muscle cells.

 

“We were surprised and pleased that modified TERT mRNA worked, because TERT is highly regulated and must bind to another component of telomerase,“ said Ramunas. “Previous attempts to deliver mRNA-encoding TERT caused an immune response against 8) ___, which could be deleterious. In contrast, our technique is nonimmunogenic. Existing transient methods of extending telomeres act slowly, whereas our method acts over just a few days to reverse telomere shortening that occurs over more than a decade of normal aging. This suggests that a treatment using our method could be brief and infrequent.“

 

Potential uses for therapy

“This new approach paves the way toward preventing or treating diseases of 9) ___,“ said Blau. “There are also highly debilitating genetic diseases associated with telomere shortening that could benefit from such a potential treatment.“ Blau and her colleagues became interested in telomeres when previous work in her lab showed that the muscle stem cells of boys with Duchenne muscular dystrophy had telomeres that were much shorter than those of boys without the disease. This finding not only has implications for understanding how the cells function — or don’t function — in making new muscle, but it also helps explain the limited ability to grow affected cells in the laboratory for study. The researchers are now testing their new technique in other types of cells.

 

“This study is a first step toward the development of telomere extension to improve cell therapies and to possibly treat disorders of accelerated aging in humans,“ said John Cooke, MD, PhD. Cooke, a co-author of the study, formerly was a professor of cardiovascular medicine at Stanford. He is now chair of cardiovascular sciences at the Houston Methodist Research Institute. “We’re working to understand more about the differences among cell types, and how we can overcome those differences to allow this approach to be more universally useful,“ said Blau, who also is a member of the Stanford Institute for Stem Cell Biology and Regenerative Medicine. “One day it may be possible to target muscle stem cells in a patient with Duchenne muscular dystrophy, for example, to extend their telomeres. There are also implications for treating conditions of aging, such as diabetes and heart 10) ___. This has really opened the doors to consider all types of potential uses of this therapy.“

Sources: Stanford University Medical Center, J. Ramunas, E. Yakubov, J. J. Brady, S. Y. Corbel, C. Holbrook, M. Brandt, J. Stein, J. G. Santiago, J. P. Cooke, H. M. Blau. Transient delivery of modified mRNA encoding TERT rapidly extends telomeres in human cells. The FASEB Journal, 2015; DOI: 10.1096/fj.14-259531; ScienceDaily.com

 

ANSWERS: 1) chromosomes; 2) dying; 3) telomeres; 4) cell; 5) drug; 6) RNA; 7) immune; 8) telomerase; 9) aging; 10) disease

 

The Medical World of Benjamin Franklin

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Benjamin Franklin (1706-1790): Source: The White House Historical Association

 

Benjamin Franklin was one of the Founding Fathers of the United States and in many ways was “the First American“. A renowned polymath (a person of wide-ranging knowledge or learning), Franklin was a leading author, printer, political theorist, politician, postmaster, scientist, inventor, civic activist, statesman, and diplomat. As a scientist, he was a major figure in the American Enlightenment and the history of physics for his discoveries and theories regarding electricity. As an inventor, he is known for the lightning rod, bifocals, and the Franklin stove, among other inventions. Franklin earned the title of “The First American“ for his early and indefatigable campaigning for colonial unity; as an author and spokesman in London for several colonies, and then as the first United States Ambassador to France.

 

Franklin was born in Boston, Massachusetts in 1706, one of ten children. He attended two years at Boston Latin School but had to leave at the age of ten, because his father could not afford more schooling. He worked for his father and at 12 he became an apprentice to his brother James, a printer, who taught young Franklin the printing trade. When Ben was 15, James founded The New-England Courant, which was the first truly independent newspaper in the colonies. Before settling in Philadelphia at the age of 21, Franklin had worked in printing shops in Philadelphia and London, then back to Philadelphia working as clerk, shopkeeper, and bookkeeper, In 1727, Benjamin Franklin, then 21, created the Junto, a group of “like minded aspiring artisans and tradesmen who hoped to improve themselves while they improved their community.“ The Junto was a discussion group for issues of the day; it subsequently gave rise to many organizations in Philadelphia.

 

Reading was a great pastime of the Junto, and Ben Franklin was a voracious reader, but books were rare and expensive. The members created a library, initially assembled from their own books. This did not suffice, however. Franklin conceived the idea of a subscription library, which would pool the funds of the members to buy books for all to read. This was the birth of the Library Company of Philadelphia, whose charter was composed by Franklin in 1731. In spite of having only two years of formal education, Franklin wanted to improve life and was one of those self-taught, problem-solving geniuses, with an insatiable curiosity. Many of his works, such as publishing that Atlantic Ocean currents make travel faster and safer, are less well-known. In this newsletter piece, we look at his medical and health works. It is important to also note that Franklin gave his inventions to the world. He would often publish them in journals, allowing others to prove and advance his work.

 

Bifocal Lenses: Ben lived his life reflecting on his own condition and finding ways to alleviate it so that others who would be in the same situation will not suffer the same way as he did. In fact, he opted not to patent his inventions since all of them are meant for the use of everybody. As he aged, he experienced eyesight issues, needing reading glasses when immersed into his most favorite hobby. But he needed to switch his reading glasses with other eyeglasses to accommodate his farsightedness problem. Hence, he kept on changing from one type of eyewear to another. To avoid such hassle, he thought of putting both types of lenses in one frame. He suggested it to his optician in France or London, and this gave birth to bifocal lenses that we are using up to this day.

 

Importance of Nutrients in Fruits: Franklin recognized that nutrients in fruits enhance one’s skin and gum health. With such observation, he recommends that this be included in the diets of sailors. This solved their common health problem, a vitamin C deficiency, which is now commonly known as scurvy.

 

Cardiovascular Exercise: Franklin noticed that whenever he work with his dumbbells, his body temperature would rise and his heart would beat faster. As a person who underwent regular and strenuous exercise, he designed a complete training drill that involves vigorous workout. He suggested that this is essential to maintaining good health. This is now known as cardiovascular exercise.

 

First Hospital in America: In 1751, Franklin, strategized with Philadelphia surgeon Thomas Bond to found the nation’s first public hospital, envisioning that it would provide free health care to the city’s “sick-poor“ and even “diseased foreigners.“ The colony’s taxpayers would foot the bill, but it would be to their benefit in the long run because making city-dwellers healthier could reduce poverty and prevent epidemics, and doctors could put experience gained in an urban hospital setting to use treating rural patients. Bond had seen the concept in action in Europe, where he had completed his medical training, and he convincedFranklin that it could work as well in Pennsylvania. Bond was unable to raise the money, so he turned to Franklin, who mounted a public relations and information campaign in support of a hospital. The colonial government finally agreed and the hospital was founded in 1751. The hospital’s mission was to serve the mentally ill, along with providing medical care to poor citizens who could not afford a private physician. The Pennsylvania Hospital is considered to be the first public hospital in the United States. While raising money for the hospital, Franklin came up with a new idea for combining public (government) money with private donations, which created the first matching grant. A 40-page account of the founding of the hospital available online through the U.S. National Library of Medicine. As Franklin wrote, “the good [that] particular men may do separately, in relieving the sick, is small, compared with what they may do collectively.“

 

Common cold: In the 18th century, most people believed that wet clothing and dampness in the air caused the common cold. However, Franklin observed that sailors, who were constantly wearing wet clothing, remained healthy. After considering the matter on and off for several years, he eventually concluded: “People often catch cold from one another when shut up together in small close rooms, coaches, and when sitting near and conversing so as to breathe in each other’s transpiration.“ Before the knowledge of viruses and germs, Franklin had determined that the common cold was passed between people through the air.

 

Lead poisoning: Franklin learned first-hand from the printing business that working with warm lead type caused his hands to become exceptionally stiff and sore. He discovered that some typesetters who warmed their type sometimes lost the complete use of their hands. Franklin decided to work with cold type from that point on. Years later, he visited a hospital in France that treated patients suffering from what was then called the “dry gripes“ or “dry belly ache.“ In analyzing the list of patients, Franklin deduced that all of them were in professions where they were exposed to large quantities of lead. Franklin finally concluded that: “I have long been of the opinion that that distemper [dry gripes] proceeds always from a metallic cause only, observing that it affects among tradesmen those that use lead, however different their trades, as glazers, type-founders, plumbers, potters, white lead-makers and painters.“ Franklin had not yet left Boston when, in 1723 the Massachusetts colonial legislature passed a bill outlawing the use of lead in the coils and heads of stills. Observance of this law led to vastly decreased incidence of the dry-gripes, as the population drank less and less lead-contaminated rum.

 

Electrical Treatments for Paralysis: Medical uses of electricity were much discussed during Franklin’s lifetime. It was known, from early in the eighteenth century, that an electrical shock could cause involuntarily twitching and contraction of muscles. Many people thus hoped that ‘electrical fire’ would provide a cure for paralysis. They believed that sending a charge through the affected limbs might increase blood flow, regenerate muscle and restore movement or physical control. Franklin was doubtful about the usefulness of electrical treatment for palsy and paralysis and never promoted himself as an electrical therapist. Nonetheless, because of his reputation as an electrical innovator, he was from time to time contacted by people seeking electrical therapy. Using an electrostatic generator (in which electrical charge was created by rubbing material against a mounted glass ball or cylinder turned by a crank) and a Leyden jar (which stored the electrical energy), Franklin obliged those patients who came to him desiring electrical therapies. He described these treatments in a letter to Sir John Pringle, dated 21 December 1757.

 

‘Some years since a number of paralytics were brought to me from different parts of Pennsylvania and the neighboring provinces, to be electris’d, which I did for them, at their request. My method was, to place the patient first in a chair on an electric stool, and draw a number of large strong sparks from all parts of the affected limb or side. Then I fully charg’d two 6 gallon glass jars, each of which had about 3 square feet of surface coated and I sent the united shock of these thro’ the affected limb or limbs, repeating the stroke commonly three times each day. The first thing observed was an immediate greater sensible warmth in the lame limbs that receiv’d the stroke than in the others. The limbs too were found more capable of voluntary motion and seem’d to receive strength. These appearances gave great spirits to the patients, and made them hope a perfect cure; but I do not remember that I ever saw any amendment after the fifth day: Which the patients perceiving, and finding the shocks pretty severe, they became discourag’d, went home and in a short time relapsed; so that I never knew any advantage from electricity in palsies that was permanent.

 

Throughout his lifetime, Franklin produced many lighter writings on health related topics as well. His advice in Poor Richard’s Almanac includes Franklin’s most famous advice on health, including such maxims as:

 

Early to bed and early to rise, makes a man healthy, wealthy and wise

Be not sick too late, nor well too soon

Time is an herb that cures all diseases

Eat to live and not live to eat.

 

Smallpox Inoculation: Many of Franklin’s medical writings showed the same spirit of public activism that characterized his civic and national projects. He repeatedly used his skills with pen and press in support of innovations that could make a difference in the public health. Most significant, perhaps, was his lifelong endorsement of smallpox inoculation. Inoculation spread rapidly in North America and Europe after its introduction into western medicine in the 1720s. The practice involved exposing healthy individuals to the disease by abrading the skin and introducing a small amount of smallpox. Typically the patient would contract a similarly mild instance of the disease and, once recovered, would have permanent immunity. Franklin wrote articles promoting inoculation and its safety as early as 1731. His support of inoculation grew after the heartbreaking loss of his 6-year-old son, Francis Folger Franklin, to smallpox in 1736. Franklin had planned to inoculate the boy at the time of an outbreak, but was unable to do so because the child was in a weakened state from another illness. Critics of inoculation suggested that Franklin’s son had been a victim of the procedure, and Franklin was forced to publish an article in his paper, The Pennsylvania Gazette, insisting that his son had contracted a natural case of the disease. Throughout his life, Franklin monitored the success of inoculation in several colonial cities, and shared information with his correspondents about the procedure’s extremely low mortality rates and the decreased smallpox incidence that resulted. The statistics he compiled were useful for Some Account of the Success of Inoculation for the Small-pox in England and America, a pamphlet he wrote with physician William Heberden.

 

Flexible Catheter: Most of Franklin’s inventions provided practical solutions to everyday problems, and Franklin brought that same inventive spirit into the medical realm. His medical creations were uncomplicated and made to be immediately useful, like the flexible catheter he designed for his brother John, who suffered from bladder stone and urinary retention. Franklin designed a device in 1757, had it made by a local silversmith, and sent it to John in Boston, with a letter detailing its design and use. The catheter was made from silver wire, coiled with joints to allow flexibility, and covered with gut. Franklin improved on conventional catheters, which were hard tubes that were inserted into the bladder through the urethra to drain urine from the body. The original devices were very uncomfortable and often painful to the patient. Franklin devised a catheter with a flexible tube, resulting in less discomfort for the patient.

 

Bladder Stone: As Franklin advanced into his eighties, his health increasingly failed. His bladder stone grew, causing him pain in movement and curtailing the active life he had enjoyed before then. The stone was probably sizable by the time it began to cause Franklin difficulty, and it only grew larger. Late in his life, he noted that he could actually feel the weight of the stone moving in his body when he rolled over in bed or shifted position. Franklin’s stone was too large for surgery by the time it caused him the greatest suffering. With the high risks of any procedure where cutting was involved, and his advanced age making the operation even more dangerous, Franklin chose to manage the stone as best he could with diet and gentle exercise. In a 1787 letter to the Comte de Buffon, a friend and fellow sufferer, Franklin noted that he had “tried all the noted Prescriptions for diminishing the Stone, without procuring any good Effect. But observing Temperance in Eating, avoiding wine and Cyder, and using daily the Dumb Bell, which exercises the upper Part of the Body without much moving the Parts in contact with the Stone, I think I have prevented its Increase.“ In his final years, Franklin took opium to combat the severe pain resulting from the stone and he was often bedridden. Franklin died on 17 April 1790, after suffering a bout of pneumonia and pleurisy. His medical legacy is similar to the legacy of the Enlightenment world in which he lived – a legacy of public health initiatives and ideas about improvement through moderation and human enterprise. Franklin’s thoughts and inventions fit squarely into this heritage, from his campaign against smallpox that paved the way for acceptance of vaccination (announced by Edward Jenner within a decade of Franklin’s death) to his invention of spectacles that could serve two purposes simultaneously. Franklin’s ideas on health and medicine depended so much upon people taking an active role in remaining healthy and improving society.

 

Finally, in his Poor Richard’s Almanac, Franklin dispensed some medical advice in the form of adages, most of which stand the test of time:

 

Don’t go to the doctor with every distemper, nor to the lawyer with every quarrel, nor to the pot for every thirst.

He’s a fool that makes his doctor his heir.

Love and toothache have many cures, but none infallible except possession and dispossession.

Pain wastes the body; pleasures, the understanding.

 

Sources: PBS.org; Journal of the Royal Society of Medicine; NIH.gov; Wikipedia; TheAtlantic.com

 

ONCOLOGY

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Molecular Alterations in Head and Neck Cancers

 

Head and neck cancers comprise a constellation of tumors of the mouth, throat, larynx, nasal cavity, salivary gland and elsewhere that have frequently been attributed to tobacco and alcohol use in most patients. Some 90% are squamous cell carcinomas, which occur in the surface layers of cells in the body. An estimated 55,000 people developed head and neck cancer in the United States in 2014, and approximately 12,000 Americans die from the diseases each year. Head and neck cancers are common worldwide, with more than 600,000 cases diagnosed each year.

 

According to an article published on in the journal Nature (28 January 2015), investigators with The Cancer Genome Atlas (TCGA) Research Network have discovered genomic differences in head and neck cancers caused by infection with the human papillomavirus (HPV). HPV is the most common sexually transmitted virus in the United States, and the number of HPV-related head and neck cancers has been growing. Almost every sexually active person will acquire HPV at some point in their lives, according to the Centers for Disease Control and Prevention. The authors also uncovered new smoking-related cancer subtypes and potential new drug targets, and found numerous genomic similarities with other cancer types. Taken together, this study’s findings may provide more detailed explanations of how HPV infection and smoking play roles in head and neck cancer risk and disease development, and offer potential novel diagnostic and treatment directions.

 

According to the authors, FDA-approved HPV vaccines should be able to prevent the cancers caused by HPV infection in head and neck cancers and elsewhere, including anal cancer, whose incidence has also been increasing.  However, these vaccines work by preventing new infections, and the long interval between infection and cancer development make it important to understand the molecular changes that bring about these HPV-positive head and neck cancers, as well as those that lead to the HPV-negative cancers.

 

In the study, the authors performed genomic analyses on 279 head and neck squamous cell carcinomas (HNSCC) from untreated patients. Approximately 80% of tumor samples were from individuals who smoked. The majority of samples were oral cavity cancers (61%) and larynx cancers (26%). Results showed that while only about 25% of head and neck cancers are linked to HPV infection, the study confirmed that many patients with HPV-associated tumors have specific alterations of the gene FGFR3 and mutations in the PIK3CA gene. These alterations are also found in a much broader set of mutations in smoking-related tumors. In contrast, while the EGFR (epidermal growth factor receptor) gene is frequently altered in HPV-negative tumors in smokers, it is rarely abnormal in HPV-positive tumors. Such insights may help in developing potential therapies and biomarkers.

 

The study also found that more than 70% of head and neck cancers had alterations in genes for growth factor receptors (EGFR, FGFR, IGFR, MET, ERBB2, DDR2), signaling molecules (PIK3CA, HRAS) and cell division regulation (CCND1). These genes may play roles in pathways that control cell growth and proliferation, and for which therapies are either available or in development. The study also discovered new clues about drug resistance in head and neck cancers, and found that genes affecting about 40% of such cancers form key parts of a pathway that helps determine cell survival and drug resistance. The study showed that extra copies of the genes FADD and BIRC2, or mutations in or the absence of the CASP8 gene in smoking-related cancers, all which affect the process of programmed cell death, may underlie the resistance of cancer cells to current treatments.  Similarly, the absence of the TRAF3 gene, or extra copies of a gene for the growth-promoting E2F1 protein in HPV-related cancers, may also increase resistance.

 

The findings showed similarities between head and neck cancer genomes and other cancers, including squamous cell lung and cervical, indicating possible common paths of cancer development, and potential treatment opportunities.

 

Novel Eye-Tracking Technology Detects Concussions, Head Injury Severity

 

Estimates from the Centers for Disease Control and Prevention state about 2.5 million U.S. emergency department visits were associated with traumatic brain injury in 2010, with rates increasing by about 70% over the previous decade. Currently there is no tool seen as a gold standard for diagnosing concussions, and imaging tests like CT-scans and MRIs are ineffective in the absence of structural damage to the brain.

 

Concussion is a condition that has been plagued by the lack of an objective diagnostic tool which, in turn, has helped drive confusion and fears among those affected and their families,” says our colleague and lead investigator Uzma Samadani, MD, PhD, assistant professor in the Departments of Neurosurgery, Psychiatry, Neuroscience and Physiology at NYU Langone. Uzma added that “Our new eye-tracking methodology may be the missing piece to help better diagnose concussion severity, enable testing of diagnostics and therapeutics, and help assess recovery, such as when a patient can safely return to work following a head injury.”

 

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For the novel eye-tracking technology, a subject watches a 4-minute video playing inside of an aperture moving around the perimetry of a video monitor while a camera records eye movements. Credit: NYU Langone Medical Center

 

The eyes have served as a window into the brain, with disconjugate eye movements — eyes rotating in opposite directions — considered a principal marker for head trauma as early as 3,500 years ago. Current estimates by optometrists suggest that up to 90% of patients with concussions or blast injuries exhibit dysfunction in their eye movements. As a result, a study published online in the Journal of Neurotrauma, developed an algorithm for eye tracking in which the Cartesian coordinates of the right and left pupils are tracked over 200 seconds and compared to each other as a subject watches a short film clip moving inside an aperture on a computer screen. For the study, the authors prospectively eye tracked 64 normal healthy non-injured control subjects and compared findings to 75 trauma subjects with either a positive head CT (n=13), negative head CT (n=39) or non-head injury (n=23) to determine whether eye tracking would reveal the disconjugate gaze associated with both structural brain injury and concussion. Tracking metrics were then correlated to the clinical concussion measure SCAT3 in trauma patients.

 

Results showed that five out of five measures of horizontal disconjugacy were increased in positive and negative head CT patients relative to non-injured control subjects. Only one of five vertical disconjugacy measures was significantly increased in brain injured patients relative to controls. Linear regression analysis of all 75 trauma patients demonstrated that three metrics for horizontal disconjugacy negatively correlated with SCAT3 symptom severity score and positively correlated with total Standardized Assessment of Concussion (SAC) score. Abnormal eye tracking metrics improved over time towards baseline in brain injured subjects seen in follow-up.

 

Dr. Robert Califf Named FDA Deputy Commissioner for Medical Products and Tobacco

 

Target Health is pleased to congratulate Dr. Robert Califf on this new appointment. Dr. Mitchel, President of Target Health, has been fortunate to collaborate with Rob at meetings of the Clinical Trials Transformation Initiative (CTTI), and on the Executive Committee of CTTI as the Steering Committee Liaison.

 

On 26 January 2015, FDA’s Commissioner Margaret A. Hamburg, M.D. announced the appointment of Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco. In this position, Dr. Califf will provide executive leadership to the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Center for Tobacco Products (CTP). He will also oversee the Office of Special Medical Programs in the Office of the Commissioner. Dr. Califf will play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities and will manage cross-cutting clinical, scientific and regulatory initiatives in several key areas for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.

 

Dr. Califf is currently serving as vice chancellor of clinical and translational research at Duke University. Other prominent roles during his tenure at Duke include director of the Duke Translational Medicine Institute (DTMI), and professor of medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. Before serving as director of DTMI, he was the founding director of the Duke Clinical Research Institute, the world’s largest academic research organization. Dr. Califf is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications.

 

During his career, Dr. Califf has led many landmark clinical studies, and is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research. He is one of our nation’s leaders in the growing field of translational research, which is key to ensuring that advances in science translate into medical care. He was a member of the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market and of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Currently, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation.

 

Dr. Califf will join the FDA in late February.

 

Refreshing, Crisp Tomato Avocado Salad

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©Joyce Hays, Target Health Inc.

 

 

Ugli Salad

 

Ingredients

 

1 endive, cleaned and cut on the diagonal (thinly sliced)

1 large, ripe (not mushy) avocado, cubed

1 thin-skin cucumber, thinly sliced

1 Ugli tomato (or beefsteak), cut into bite-size chunks

6 green olives

1 Tablespoon olive oil

1/2 fresh lemon, squeezed

1 garlic clove, juiced

Pinch salt (optional)

Pinch black pepper (or to your taste)

 

Directions

 

Into a small bowl add the last 5 ingredients and mix. Set aside

 

Into your salad bowl add the first 5 ingredients, toss. Now, add the dressing, slowly pouring it over the veggies. Toss again and serve

 

 

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We want to share this recipe with you because this particular salad is one of our favorites, plus it’s quick and easy to make. We like it because it’s so refreshing and crisp with a marvelous combination of flavors. We like it so much that we have it about twice a week.

 

On this night, we started dinner with the wine, below, a “Cab“ from Napa Valley and the delicious salad shared in this newsletter.

 

The salad was so good, we finished it all.

 

Then we moved onto filet mignon (Angus, center cut, no antibiotics) medium rare with a marsala mushroom gravy. The filet mignon from FreshDirect is so good, it’s better than any we’ve ever had at the best steak houses.

 

Now, we never order steak in a restaurant, and only get it about once a month from FreshDirect and cook it at home.

 

To go with the steak I bought specially grown, tiny red potatoes, (FreshDirect) let them soak in seasoned olive oil and then baked them in the oven. Each whole tiny potato is one bite and one flavorful bite, at that. Dessert was cut up Sumo tangerines in Cointreau.

We agreed this meal rated a five (our top rating)

 

We saw a fantastic play at Manhattan Theater Club, called Constellations, where the playwright sets his characters and their lives against a background of (quantum physics) String theory. Brian Greene the well-known Columbia University physicist, was the advisor to this production. The stage craft was extraordinary and the experience was enthralling. Go if you can.

 

 

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Chateau Montelena, Napa Valley Cabernet Sauvignon, 2012

 

“The 2012 Cabernet Sauvignon Napa Valley is meant for up-front, immediate drinkability, and is primarily designed for restaurants. It reveals Montelena’s damp earthiness and spiciness as well as a dark ruby color, no evidence of oak, and medium-bodied, spicy flavors. Drink it over the next 6-8 years. An iconic offering, their Cabernet Sauvignon Estate has long been one of the staples in my private cellar with vintages going back to the 1970s. It has been one of the longest-lived wines in Napa“ – Wine Advocate

 

 

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From Our Table to Yours!

 

Bon Appetit!