eClinical Forum Spring Meeting

 

The Spring Meeting of the eClinical Forum (eCF) will be in Indianapolis this week so hope to see you there. Dr. Mitchel will be sharing Target Health’s hands-on experience with the electronic informed consent (Target e*ICF™) which is ongoing in a multicenter study in the US and Japan.

 

The eCF is a non-commercial group working to improve the use of technology in clinical research. Target Health has been a member for many years and is pleased to be part of the Regulatory Expert Team. The team provides expert evaluation of regulatory guidances from Europe, North America and Asia Pacific so that the impact of technology tools on clinical research can be assessed. Consolidation of review comments via this group ensures that the eCF can respond efficiently to regulatory agency timetables for return of comments.

 

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. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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Magnesium: For Good Health, We Cannot Do Without This Mineral

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Vapor-deposited magnesium crystals from the Pidgeon process

 

Magnesium is a mineral that is important for normal bone structure in the body. People get magnesium from their diet, but sometimes magnesium supplements are needed if magnesium levels are too low. Dietary intake of magnesium can be particularly low among women. Magnesium deficiency is also not uncommon among African Americans and the elderly. Low magnesium levels in the body have been linked to diseases such as osteoporosis, high blood pressure, clogged arteries, hereditary heart disease, diabetes, and stroke.

 

An easy way to remember foods that are good magnesium sources is to think fiber. Foods that are high in 1) ___ are generally high in magnesium. Dietary sources of magnesium include legumes, whole grains, vegetables (especially broccoli, squash, and green leafy vegetables, Brussels sprouts), asparagus, seeds, and nuts (especially almonds). Other sources include dairy products, meats, chocolate, and coffee. Water with a high mineral content, or “hard“ water, is also a source of magnesium.

 

People take magnesium by mouth to prevent magnesium deficiency. It is also used as a laxative for constipation and for preparation of the bowel for surgical or diagnostic procedures. It is also used as an antacid for acid indigestion. Some people use magnesium for diseases of the heart and blood vessels including chest pain, irregular heartbeat, high blood pressure, high levels of “bad“ cholesterol called low-density lipoprotein (LDL) cholesterol, low levels of “good“ cholesterol called high-density lipoprotein (HDL) cholesterol, heart valve disease (mitral valve 2) ___), metabolic syndrome, clogged arteries (coronary artery disease), stroke, and heart attack. For decades, statisticians have demonstrated that the majority of Americans do not get the government’s minimum daily requirement for magnesium. The latest government study shows a staggering 68% of Americans do not consume the recommended daily intake of 3) ___. Data from this study show that 19% of Americans do not consume even half of the government’s recommended daily intake of magnesium.

 

The National Institutes of Health published the following on its website:

 

“Magnesium is needed for more than 300 biochemical reactions in the body. It helps maintain normal muscle and nerve function, keeps heart rhythm steady, supports a healthy immune system, and keeps bones strong. Magnesium also helps regulate blood sugar levels, promotes normal blood pressure, and is known to be involved in energy metabolism and protein synthesis. There is an increased interest in the role of magnesium in preventing and managing disorders such as hypertension, cardiovascular disease, and diabetes.“

 

A recent study showed that adults who consume less than the recommended amount of magnesium are 1.48 to 1.75 times more likely to have elevated C-reactive 4) ___. The reasons for such widespread magnesium deficiencies include increased consumption of processed foods, water purification that removes natural minerals, and mineral-depleted soil. Universal drinking water and beverages containing moderate to high levels of magnesium (10-100 ppm) could potentially prevent 4.5 million heart disease and stroke deaths per year, worldwide. This potential is calculated with 2010 global mortality figures combined with a recent quantification of water-magnesium’s inverse association with heart disease and stroke mortality. Today’s processed food diet, low in magnesium and spreading globally, makes this well-researched potential of drinking-5) ___ magnesium worth serious consideration, especially in areas where insufficient dietary intake of magnesium is prevalent. Recent studies confirm the strong, essential role magnesium plays in the prevention of cardiovascular diseases. Adequate magnesium is vital in preventing atherogenesis and inappropriate clotting, in maintaining vascular tone, electrolyte balance and a host of other cellular, biochemical and physiological processes crucial to cardiovascular function and health. People living in areas with low-magnesium water have high rates of heart attack and stroke death, higher than people living in areas of high-magnesium water who seem to be protected. In fact, data tells us that consumption of drinking water even moderately high in magnesium (at least 10 ppm and up to 40 ppm and higher) can be expected to reduce cardiovascular 6) ___ by 30-35%.

 

Magnesium in the USA food supply dropped substantially between 1900 and 2010 mostly due to food processing advances, including farming techniques. Significant decreases in magnesium concentration in vegetables and high-yield grains, have been documented. Additionally, water-softening technology has become almost universal in USA homes during the past half century, removing much of the magnesium and calcium from household water supplies used for cooking and drinking. Experimental animals, made magnesium deficient with low magnesium food, show subcellular markers linked to heart 7) ___. Giving drinking-water with added magnesium to these animals lessened these markers even at magnesium levels as low as 15 ppm. Water magnesium levels of 100 ppm appears to reverse some of these markers. Similar to these animal study experiments, human population studies show that populations with less than 3-6 ppm magnesium drinking water have higher rates of mortality from heart disease, and that rate goes down as the magnesium concentration of their water goes up, the higher the better.

 

Experts in this field tell us that total magnesium intake must be at least 450-500 mg per day, and drinking water should contain a minimum of 25-50 ppm magnesium. Two liters of 25-50 ppm magnesium water would provide 15-25% of adult RDAs. To ascertain a minimum level of effective water-magnesium we can draw from studies by Rubenowitz that found only daily water-magnesium intakes above 13.8 mg to be protective. Most bottled waters contain little, if any, magnesium. At this time in the USA, very few high magnesium mineral waters are available. One, Adobe Springs water, in California, appears to be an exception as it is both high in magnesium (96-110 ppm) as well as low in both calcium and sodium, aspects that can be important to health. Calcium intakes from food have risen substantially in the USA over the past 30 years, just as recommendations for calcium supplementation to prevent osteoporosis became widespread. Both of these high calcium trends have occurred in the face of 8) ___ magnesium intakes, and there is rising evidence that this trend poses dangers to heart health.

 

Calderon and Hunter state, in the 2009 World Health Organization report, Calcium and Magnesium in Drinking Water, Public Health Significance (74, Page 141):

 

Epidemiological evidence supports the link between magnesium and cardiovascular mortality. Such an association is consistent with evidence of the cardiovascular effects of magnesium deprivation and of inadequate magnesium in the diets of people from developing countries.

 

Magnesium is also used for treating attention deficit-hyperactivity disorder (ADHD), anxiety, chronic fatigue syndrome (CFS), Lyme disease, fibromyalgia, cystic fibrosis, alcoholism, mania, recovery after surgery, leg cramps at night and during pregnancy, diabetes, kidney stones, migraine headaches, a long-term pain condition called complex regional pain syndrome, weak bones (osteoporosis), premenstrual syndrome (PMS), altitude sickness, urinary incontinence, a condition that causes burning pain and redness called erythromelalgia, restless leg syndrome, asthma, hayfever, multiple sclerosis, and for preventing hearing loss and cancer.

 

Athletes sometimes use magnesium to increase energy and endurance. Some people apply magnesium on their skin to treat infected skin ulcers, boils, and carbuncles; and to speed up wound 9) ___. Magnesium is also used as a cold compress in the treatment of a severe skin infection caused by strep bacteria (erysipelas) and as a hot compress for deep-seated skin infections. Magnesium is injected into the body for nutritional purposes and to treat magnesium deficiency that occurs in people with pancreas infections, magnesium absorption disorders, and cirrhosis. It is also injected to treat high blood pressure during pregnancy and other pregnancy complications. Magnesium is also used as an injection to control seizures, to treat irregular heartbeat, to control irregular heartbeat after a heart attack, and for cardiac arrest. Magnesium is also injected into the body to treat asthma and other lung disease complications, for migraines and cluster headaches, jellyfish stings, poisonings, pain, swelling in the brain, chemotherapy side effects, head trauma and bleeding, sickle cell disease, to prevent cerebral palsy, and for tetanus. Magnesium is required for the proper growth and maintenance of bones. Magnesium is also required for the proper function of nerves, muscles, and many other parts of the body. In the stomach, magnesium helps neutralize stomach 10) ___.

 

Editor’s note: You can be sure, that upon reading about bottled water with high content magnesium, from Adobe Springs, CA, we ordered a case of their bottled water (brand Noah).

 

Editor’s note: we used a magnesium spray for an allergic response that caused extremely itchy skin. It worked almost immediately and when used each day, the itchiness gradually disappeared. However, we would not presume to advise any reader about a medical condition, except to say, ask your doctor before using anything.

 

ANSWERS: 1) fiber; 2) prolapse; 3) magnesium; 4) protein; 5) water; 6) mortality; 7) disease; 8) low; 9) healing; 10) acid

 

Dr. Pierre Delbet and the Importance of Magnesium

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Photo source: http://ihm.nlm.nih.gov/images/B06079, Public Domain, https://commons.wikimedia.org/w/index.php?curid=19291401

 

Pierre Delbet (1861- 1957) was a French surgeon born in La Ferte-Gaucher. In 1889 he received his medical doctorate, and in 1909 became a professor of clinical surgery in Paris. In 1921 he became a member of the Academie de Medecine. Delbet is remembered for his advocacy of magnesium chloride. During World War I, Delbet was searching for a solution that could cleanse wounds but not damage tissue as traditional antiseptics did. In 1915 he found that magnesium chloride not only worked as an antiseptic, but was also harmless to body tissue. Serendipitously, he discovered that when the magnesium chloride solution was taken orally or intravenously, it appeared to be a remedy for other ailments. Delbet also believed that magnesium was beneficial to the efficiency of white blood cells, of which he described in his treatise “Politique Preventive du Cancer“.With Jean-Fran?ois-Auguste Le Dentu (1841-1926) and others, he was co-publisher of the multi-volume Traite de chirurgie clinique et operatoire (1901 et seq.).

 

Pierre Delbet, the son of a physician, was conferred doctor of medicine in 1889 in Paris, becoming agrege there in 1892; in 1893 Chirurgien des Hopitaux and 1909 professor of clinical surgery at the Academy of Clinical Surgery in Paris. He was co-publisher of the Traite de chirurgie clinique et operatoire as well as the Nouveau traite de chirurgie. He was a member of the Academie de Medecine from 1921. Pierre Delbet is also remembered for his views on magnesium as a miracle mineral. In 1915 he was looking for a solution to cleanse wounds of soldiers, because he found that traditionally used antiseptics actually damaged tissues and encouraged infections instead of preventing them. In all his tests magnesium chloride solution was by far the best. On September 6 that year, with Dr. Karalanopoulo, he submitted to the French Academy of Science the paper Cytophylaxis, advocating that magnesium increases the efficiency of the white blood cells. Delbet devised three apparatuses that have been named for him in the French literature: for fractures of the humeral diaphysis, for ambulatory treatment of the thigh bone, and one for ambulatory treatment of fractures of the lower leg. He also developed an apparatus for assisted walking, treatment for fractures of the neck of the femur, and treatment for Dupuytren’s fracture. Delbet also devised a clinical test for assessing the patency of the deep femoral veins, used in preparations for operation for varicose veins. With the patient standing and veins filled, a tourniquet is placed around the mid-thigh and the patient walks for 5 minutes. If the saphenous veins collapse below the tourniquet the deep veins are patent and the communicating veins are competent; if unchanged, both saphenous and communicating veins are incompetent and if the veins increase in prominence and pain occurs the deep veins are occluded.

 

Dr. Pierre Delbet worked with and exchanged ideas with Dr. Joseph Favier, who was also interested in effects of magnesium and showed how valuable magnesium as a medicament is for many diseases. Dr. Delbet and Dr. Favier deserve credit for being the first to discover magnesium chloride as an effective agent in treating urinary troubles of prostate origin. They informed the Medical Academy of France of it, on March 18, 1930. In their continued research they found that many physician colleagues were taking magnesium chloride and that four out of five of them had been disturbed by difficulties in urinating, especially at night. And all of them, after taking the magnesium tablets, found that their nocturnal urinating troubles diminished or disappeared. Twelve prostatic cases were treated with magnesium tablets. Ten of them were cured. One disappeared, and it was not known what the result was with him. The one that was not cured was left with nothing more than nightly urinations. The interesting thing is that the general physical condition of all these patients improved. There seemed to be something about magnesium that was healthful for the body.

 

Case No. 4, was a 77-year-old prostatic patient who suffered a crisis of complete retention of urine. He had to be probed in order to urinate. His prostate was very much enlarged. Probes were carried on three times a day up to November 24, (1930) and hot clysters (enemas) were administered. The first spontaneous urination took place on November 25; the probes were cut off on December 7. On December 10, the patient urinated five times a night and he had a big residue. The dosage was four tablets (2 g.), and went on until February 21, 1930. The nightly urinations fell from five to three, and the residue dropped to 20 grams. The patient, having recovered his strength, believing he was cured, discontinued the treatment. The frequency of urinations increased, and three days later, on February 24, the residue had gone up to 126 grams. The magnesium treatment was resumed, the frequency of urinations curtailed, and on March 21, the patient informed the doctor that he urinates only two to three times a night.

 

Patient 13, who had been a case of complete retention of urine: was sent to the hospital in order to have an operation of the prostate performed; that is, to have his prostate removed. But doctors felt that the operation in his case would be too dangerous. He was therefore given the magnesium chloride tablets. Spontaneous urination occurred, and the patient left the hospital without the operation. From then on he had no difficulty or pain with his urinations. Thereafter the patient used to come to the hospital regularly merely as a friendly visitor to show his gratitude to the doctor. He was, of course, taking magnesium tablets after he left the hospital.

 

Drs Delbet and Favier wrote that among the men who had been taking magnesium chloride tablets for many years, none to their knowledge, suffered from prostatic trouble, again. In connection with some of these cases and their cure, Dr. Pierre Delbet in Academy of Medicine (Paris), session of March 25, 1930, said, in regard to how magnesium acts on the body:

 

“As magnesium adds to the contractibility of smooth muscle fibers, one may wonder if the treatment doesn’t act uniquely on the bladder, inasmuch as there isn’t any parallel between reduction in size of the adenoma [a tumor of glandular origin] and functional improvement. But if, in certain cases, this improvement is considerable, when reduction in size is slight, which is favorable to the hypothesis, in other cases, it’s quite the contrary, the reduction is quite more marked than functional improvement.

“In an earlier communication, M. Bretau and I have shown that age is accompanied by a reduction in magnesium in the most active organs and that the absorption of halogenated salts permits a struggle against certain manifestations of senility.

“Hypertrophy of the prostate is a complaint of waning life and perhaps the one which strikes most terribly. The facts communicated by M. Stora, which I have just reported and which belong to M. Chevassu, show that it is one illness which can be modified by halogenated magnesium salts.

“The preceding observations show that halogenated magnesium salts sometimes have an extraordinary action in very advanced cases. The sick man in observation XIII, who had complete retention, comes to see me regularly at Cochin to express his gratitude. He came right at the time of my retirement, that is to say during 16 months. He continued to take the treatment and urinated without difficulty.

“Since that time, a number of prostate sufferers, whom I don’t know, have expressed their gratitude to me for the services that delbiase [a magnesium compound] rendered them.

“Its mode of action is completely obscure to me. What is striking is that the effects stop from the moment that the treatment is stopped. The subject of observation IV is an example. His nocturnal urinations were reduced to three and the residue, which had been considerable, fell to 20 grams. He stopped the treatment and in three days, the frequency of his urinations increased and the residue rose to 125 grams.

“One of my former pupils, a distinguished surgeon, has communicated his own observation to me. It appears to be very interesting. He had nocturnal urinations whose frequency increases all the time. He put himself on the delbiase regimen. His urination became less frequent. “My life,“ he said, “was completely untroubled. I could only complain that drinks were a little more frequent and a little more demanding than I should have liked.“ At the beginning of the war, he was mobilized and sent to be a surgeon at the front where he couldn’t get any delbiase. His urinations became more frequent and assumed painful proportions. His general health was affected. Two and a half months after the treatment was stopped, it was noted that he had a residue of 220 grams.

“In sum, the effect of halogenated salts of magnesium isn’t lasting. They improve or even suppress functional difficulties; they don’t heal the lesions. They cause them to retrocede in a certain number of cases, but they don’t cure them. As soon as the treatment is stopped, the development begins anew. Doesn’t that prove in a peremptory manner that an insufficiency of magnesium in the organism is the cause, or at least one of the causes, of these lesions?“

After much research with magnesium, Dr. Delbet developed ideas on senility and concluded: that that “all organs and tissues do not age at the same speed. The muscular system generally lasts the shortest period, the nervous system the longest. The role of magnesium in organic synthesis leads one to think that it must diminish with age. Weiske’s research shows that magnesium is less abundant in the bones of old rabbits than it is in those of young ones. In the human testicles a decline in magnesium was demonstrated as a person ages, but in old age calcium is more abundant than magnesium – three times more abundant. But here is something extremely interesting, calcium is considered as a “framework“ mineral, but magnesium is an “action“ mineral. Calcium is static, magnesium is dynamic. He continues, “Added calcium and reduced magnesium are the characteristics of the senile testicle. In the brain and in the testicle, the relationship with age are the same degree, but it appears certain to us that at the time that life is waning, magnesium diminishes while calcium rises. Now, everything that is known about the chemical magnesium, about its action in the synthesis of chlorophyll, justifies one in thinking that its reduction plays a role in senility, or at least in certain phenomena of senility. If magnesium in the body becomes less abundant as we grow old, and since medical researchers have shown that deficiencies of magnesium lead to many diseases, isn’t it common sense to increase magnesium as a food or food supplement on a permanent basis?

 

Healthy Diet May Reduce Hypertension Risk After Gestational Diabetes

 

Approximately 5% of pregnant women in the United States develop gestational diabetes, despite not having diabetes before becoming pregnant. The condition results in high blood sugar levels, which can increase the risk of early labor and a larger than average baby, which may result in problems during delivery. For most women with gestational diabetes, blood sugar levels return to normal after birth. However, later in life, women who had gestational diabetes are at higher risk for type 2 diabetes and high blood pressure.

 

According to a study published online in Hypertension (19 April 2016), it was concluded that sticking to a healthy diet in the years after pregnancy may reduce the risk of high blood pressure among women who had gestational diabetes. In fact, a healthy diet was associated with lower risk for high blood pressure even in obese women. Obesity is a risk factor for high blood pressure.

 

The current study is the first to show that adopting a healthy diet — known to reduce high blood pressure risk among the general population — also reduces the risk among women with prior gestational diabetes. In an earlier study, it was reported that a healthy diet after gestational diabetes reduces the risk for Type 2 diabetes.

 

The study analyzed the health histories of nearly 4,000 women participating in the Nurses’ Health Study II, part of the Diabetes & Women’s Health study. Every four years, study participants responded to questionnaires on their eating habits. When appropriate, the women’s responses were categorized according to three healthy dietary approaches: the Alternative Healthy Eating Index, Mediterranean-style Diet, and the Dietary Approaches to Stop Hypertension (DASH). These approaches emphasize consumption of nuts, legumes, whole grains and fish, and limit consumption of red and processed meats, salt, and added sugars.

 

After they statistically accounted for smoking, family history, and other factors known to increase high blood pressure risk, the study found that women who adhered to a healthy diet were 20% less likely to develop high blood pressure than those who did not. The authors stated that as is well-known that high blood pressure affects about 30% of U.S. adults and increases the risk for heart disease, kidney disease, and stroke, the present study shows that a healthful diet is associated with decreased high blood pressure in an at-risk population.

 

Islet Transplantation Restores Blood Sugar Awareness and Control in Type 1 Diabetes

 

NIH-funded study lays groundwork for potential application submission to FDA for licensure of islet preparation.

 

Hypoglycemia, or low blood sugar, typically is accompanied by symptoms such as tremors, sweating and heart palpitations that prompt people to eat or drink to raise their blood sugar levels. Those who do not experience these early warning signs — a condition called impaired awareness of hypoglycemia — are at increased risk for severe hypoglycemic events, during which the person is unable to treat himself or herself. Treatments such as behavioral therapies or continuous glucose-monitoring systems can prevent these events in many — but not all — people with this impaired awareness, leaving a substantial number of people at risk.

 

In type 1 diabetes, the immune system attacks and destroys insulin-producing cells in the islets of the pancreas. Therefore, people with type 1 diabetes need lifelong treatment with insulin, which helps transport the sugar glucose from the bloodstream into cells, where it serves as a key energy source. Even with insulin therapy, people with type 1 diabetes frequently experience fluctuations in blood sugar levels.

 

According to an article published online in Diabetes Care (18 April 2016), new clinical trial results show that transplantation of pancreatic islets — cell clusters that contain insulin-producing cells — prevents severe, potentially life-threatening drops in blood sugar in people with type 1 diabetes. The study also found that the treatment was effective for people who experienced episodes of severe hypoglycemia — low blood sugar levels that can lead to seizures, loss of consciousness and death — despite receiving expert care.

 

The Phase 3 trial was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and was conducted by the NIH-sponsored Clinical Islet Transplantation (CIT) Consortium. The investigators designed the study in consultation with the FDA to enable potential future licensure of the manufacture of purified human pancreatic islets.

 

Clearly, the treatment carried risks, including infections and lowered kidney function as a result of people taking the immune-suppressing drugs needed to prevent rejection of the donor islets. Although some of the side effects were serious, none led to death or disability. According to the NIH, while the procedure is still experimental, and with risks that must be weighed carefully, the promise of islet transplantation is undeniable and encouraging, as even with the best care, about 30% of people with type 1 diabetes aren’t aware of dangerous drops in blood glucose levels.

 

The current study enrolled 48 people who had persistent impaired awareness of hypoglycemia and experienced severe hypoglycemic events despite expert care by a diabetes specialist or endocrinologist. The study used a standardized manufacturing protocol to prepare purified islets from the pancreases of deceased human donors, and all study participants received at least one transplant of islets injected into the portal vein, the major vessel that carries blood from the intestine into the liver. Islet recipients currently must take immunosuppressive drugs for the rest of their lives to prevent their immune systems from rejecting the transplanted cells.

 

Results showed that one year after the first transplant, 88% of study participants were free of severe hypoglycemic events, had established near-normal control of glucose levels, and had restored hypoglycemic awareness. After two years, 71% of participants continued to meet these criteria for transplant success. Participants who still needed insulin 75 days after transplant were eligible for another islet infusion. Twenty-five participants received a second transplant, and one received three. After one year, 52% of study participants no longer needed insulin therapy.

 

The authors are continuing to follow participants to determine whether the benefits of restoring near-normal blood glucose control and protection from severe hypoglycemic events will outweigh the risks associated with chronic immunosuppression.

 

FDA Launches First Ad Campaign Focused on Dangers of Smokeless Tobacco Among Rural Teens

 

Smokeless tobacco includes different types of products, such as dip, chew, snuff and types of tobacco that dissolve when placed in the mouth. According to the Substance Abuse and Mental Health Services Administration, each day in the U.S. nearly 1,000 males under the age of 18 use smokeless tobacco for the first time – almost as many male teenagers who smoke their first cigarette – making early intervention critical and highlighting a need for targeted youth smokeless tobacco prevention.

 

Smokeless tobacco use is culturally ingrained in many rural communities. For many, it has become a rite of passage, with these teenagers seeing smokeless tobacco used by role models, such as fathers, grandfathers, older brothers and community leaders. In fact, its use is more than twice as likely in rural areas compared to metropolitan areas in the U.S. However, some rural youth are impacted more significantly than others – with white, male youth being more likely to use smokeless tobacco than other youth. According to the most recent data from the FDA’s Population Assessment of Tobacco and Health (PATH) study, 31.8% of rural, white males 12-17 years of age are either experimenting with, or at-risk for, using smokeless tobacco – this amounts to approximately 629,000 male youth nationwide.

 

The FDA has announced that it is expanding its award-winning “The Real Cost“ campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically selected to reach the campaign’s target audience. The central message in “The Real Cost“ Smokeless Tobacco Prevention Campaign is “smokeless doesn’t mean harmless,“ which aims to motivate these teenagers to reconsider what they think they know about smokeless tobacco use. The FDA’s strategic approach is based on key insights from multi-state focus groups consisting of rural, white males, ages 12-17, as well as by extensive secondary research. Campaign messaging focuses on topics that the FDA’s research found to resonate with at-risk youth, such as cosmetic and health consequences, loss of control due to addiction, and the danger of chemicals found in smokeless tobacco products.

 

“The Real Cost“ Smokeless Tobacco Prevention Campaign’s messages are being amplified across the U.S. using a variety of methods, including traditional paid media (e.g., television, radio, print, public signs and billboards), as well as digital advertising and social media. These efforts will be evaluated by measuring the advertisements’ effectiveness in reaching rural, white male teenagers and changing their thinking, attitudes, beliefs and behavioral intentions to use smokeless tobacco. The new campaign will also collaborate with select Minor League Baseball teams to help combat the link between baseball and smokeless tobacco use among the campaign’s target audience. This summer, stadiums across the country will promote tobacco-free lifestyles by displaying campaign advertising and providing opportunities for fans to meet and interact with players who support the campaign’s public health messages.

 

“The Real Cost“ Smokeless Tobacco Prevention Campaign is part of the FDA’s ongoing efforts to prevent at-risk youth from starting to use tobacco. These efforts include the FDA’s general market campaign, “The Real Cost,“ launched in February 2014, and the agency’s “Fresh Empire“ campaign targeting multicultural youth who identify with the hip-hop peer crowd, launched in October 2015.

 

Asparagus Ribbon Salad with Parmesan, Pine Nuts & Lemon

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Tender asparagus is still in Season. Here’s another easy recipe using locally grown organic asparagus. ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

2/3 cup pine nuts, toasted, plus extra (toasted) for garnish
1 pound fresh, (organic) locally grown fat asparagus, rinsed
1 lemon, halved

1.5 Tablespoons fresh lemon juice

Zest of 1/2 lemon

Lemon circles, for garnish
2.5 Tablespoons extra virgin olive oil

1 fresh garlic clove, juiced

1 Tablespoon fresh chives, minced

Pinch turmeric (that comes with black pepper, already mixed in)

Pinch black mustard seeds, toasted (optional)

Pinch chili flakes

Pinch, black pepper

1/2 cup freshly grated Parmesan or more

 

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Asparagus in season, is so tender now. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

Toast the pine nuts and the black mustard seeds together. Keep your eye on them and stir constantly so they don’t burn. You’ll have to do them over if they burn. Set aside.

 

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Toast the pine nuts yourself; it really adds to the overall flavor. ©Joyce Hays, Target Health Inc.

 

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Chop the chives, slice the lemons and set aside. ©Joyce Hays, Target Health Inc.

 

 

Rinse the asparagus, then make the asparagus ribbons

To shave the asparagus lay a stalk flat on a cutting board, holding it at the base. Usually, with asparagus recipes, you snap off the tough bottom, that’s too tough to eat. In this recipe, don’t snap it off, so you have something to hold onto when you make the asparagus ribbons.

Gripping the base, at about where the pale base turns green, use a vegetable peeler to shave the stalk in long, even strips all the way through the tip. Be sure to peel the asparagus ribbon, all the way to the end of the tip. Some of your ribbons will have part or all of the tip and others won’t. That’s okay. The end result will be a lovely variety of ribbons.

The best peeler to use, is the Y-shape one. Peel again until you’re about half way through the stalk, then turn over and peel the other side. When you reach the point that the peeler will no longer shave the spear, rest the spear on top of a wooden spoon (or wooden spatula) with a flat handle, to elevate the spear and take the last two or three strips. Peel all of the asparagus spears, like this.

 

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Peeling the asparagus ribbons. ©Joyce Hays, Target Health Inc.

 

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So-o easy to make asparagus ribbons and your salad will look so lovely. ©Joyce Hays, Target Health Inc.

 

 

Grate the parmesan.

 

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It always tastes better, when you grate your own parmesan. Get a quality chunk of it at a reliable store. ©Joyce Hays, Target Health Inc.

 

 

Combine asparagus shavings, toasted pine nuts and toasted black mustard seeds, in a large salad (serving) bowl, and toss gently. Save some of the nuts for garnish.

In a small bowl, place the minced chives and the garlic juice in the bottom of the bowl and cover with olive oil. Add lemon juice, zest, chives, turmeric and pinch chili flakes, and whisk until smooth.

 

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In a small bowl, make the vinaigrette. ©Joyce Hays, Target Health Inc.

 

 

If you toss this salad ahead of time, the ribbons wilt a little. They lose some of their perkiness. Therefore, just minutes before your meal begins, pour the vinaigrette dressing over the asparagus mixture and toss gently with salad servers, to lightly coat all of the asparagus ribbons.

Season according to your taste, if needed.

Finally, sprinkle the salad with the freshly grated parmesan and toss.

Garnish with a few toasted pine nuts. Place the lemon circles around the bowl for decoration.

Serve immediately.

 

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One night we just had chilled white wine with crusty Italian bread dipped in extra virgin olive oil and this asparagus ribbon salad; fresh fruit for dessert.  ©Joyce Hays, Target Health Inc.

 

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This is the third time this month, that I’ve made asparagus ribbon salad.  Tonight, we started with icy white wine, and a Nova Scotia Salmon appetizer; followed by this salad and kale/mushroom patties with avocado pureed topping and strawberry jello cake. ©Joyce Hays, Target Health Inc.

 

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Nothing says, Spring, like the sweet smell of hyacinths. ©Joyce Hays, Target Health Inc.

 

 

We saw Frank Langella give the most brilliant performance we’ve seen all year in a play called, The Father, by Florian Zeller. It’s on Broadway at the Samuel J. Friedman Theater, for a limited run that ends sometime this coming June.

 

The unique crafting of this play, takes the audience, back and forth in time, plus in and out of the aging psyche, superbly played by Frank Langella. The starring role is extremely difficult because of the many mental twists and turns, but the genius of Frank Langella captures all the delicate nuances of the leading character. I predict that this play will win more than one Tony Award for 2016. Buy your tickets first thing on Monday, so you don’t miss a terrific play and a once in a lifetime performance. We are very proud to be patrons of this event. The world needs more great theater like, The Father.

 

 

From Our Table to Yours !

 

Bon Appetit!