Disruptive Innovations (DPharm) Meeting – September 20-21 (Boston)

 

If you can make it, join us at Disruptive Innovations US (September 20 – 21, 2016), being held at The Fairmont Copley Plaza, Boston. This is the best meeting for those interested in change and getting things to happen. This year, Dr. Jules Mitchel, President of Target Health Inc. will talk about Target Health’s accomplishments in the area of the paperless clinical trial, including highlighting an FDA-cleared product where eSource (Target e*CTR®) was used in the pivotal trial.

 

The DPharm meeting is a TED-style event showcasing innovators from leading Pharma companies and from other industries. The conference highlights the promises and challenges of innovation in advancing drug development and features new models and collaborations to get therapeutics to patients faster. DPharm also features the full spectrum of clinical research options and is dedicated to finding ways for implementation. Finally, DPharm will explore the companies who are being disruptive so we can all gain a better understanding of how novel approaches are impacting the clinical trial ecosystem.

 

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, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

QUIZ

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Pollution Particles in the Brain Linked to Alzheimer’s Disease

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Increased coal fires burned in London, the winter of 1952, causing deadly air pollution.

Photo source: N T Stobbs, Commons.wikimedia.org/w/index.php?curid=4094275

 

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Photo source: Air Pollution in Hong Kong on two different days.

By Tokyoahead at English Wikipedia: https://commons.wikimedia.org/w/index.php?curid=27157072

 

 

Microscopic analysis has shown, for the first time, tiny magnetic particles from air pollution lodged in human brains. Researchers believe the large volume of magnetite particles found in brain samples suggest a possible link with Alzheimer’s disease. “Air pollution particles linked to Alzheimer’s found in human brain,“ New research has found tiny particles of magnetite – a potentially toxic by-product of traffic pollution – in samples of 1) ___ tissue. The samples, obtained after death, were taken from 29 people from Mexico City and eight people from Manchester England.

 

Magnetite is formed naturally in small quantities in the body, but the shapes of the naturally formed particles are jagged and irregular, while the particles found in the brain samples were spherical with smooth, fused surfaces. Magnetite may increase oxidative damage – damage caused at the molecular level – to brain cells, especially in the presence of amyloid beta protein, a key protein linked to 2) ___ disease. While it’s worrying to think pollution particles can enter the brain, it’s unclear what role, if any, these particles really have in the development of the disease. The people studied did not have Alzheimer’s disease, although some of the eight people from the UK had a neurodegenerative disease. The researchers have called for more work to be done to establish whether or not 3) ___ particles from air pollution play a role in causing Alzheimer’s disease. Independent experts have reacted with caution, saying this is as yet unknown.

 

Air pollution levels have fallen significantly in the UK in the last 40 years, but there has not been a corresponding fall in Alzheimer’s cases, possibly making the link between the two harder to determine. The study was carried out by researchers from the University of Lancaster, the University of Oxford, the University of Glasgow, the University of Manchester, the University of Montana and Universidad Nacional Autonoma de Mexico, and published in the Proceedings of the National Academy of Sciences (6 September 2016). The study analyzed brain tissue samples using four types of particle analysis processes. This type of study can show that these specific particles are present in the brains of the people studied, but nothing else. It can’t tell us whether these particles are found in everyone’s brains or just in the brains of people who live in 4) ___ areas, or whether they are more common in people with Alzheimer’s disease. The study took samples of brain tissue from 29 people from Mexico City aged 3 to 85 years, and eight people from Manchester in the UK aged 62 to 92 years, and analyzed the samples using four different scanning and analysis procedures to examine the minerals, shape and composition of nanoparticles found in the frontal 5) ___ of the brains. The researchers looked at the number and size of the particles. They also compared the qualities of the particles found with previously identified naturally occurring magnetite particles, and also with particles found in air samples taken at roadsides in Lancaster. The study found that all of the brain samples contained “abundant“ magnetite particles “that match precisely the high-temperature magnetite nanospheres formed by combustion and/or friction-derived heating, which are prolific in urban, airborne particulate matter“. The concentrations were mainly highest among older people, although some of the samples taken from much younger Mexico City residents were also very high. Mexico City is known to have high levels of 6) ___ pollution. The researchers say they found two types of particles: the jagged types thought to form naturally, and the spherical, smooth type consistent with particles produced by air pollution. These rounded forms also varied in size much more than the smaller naturally occurring variety. The researchers say their results may explain previous research, which found spherical particles of magnetite in the plaques and tangles of protein in brain tissue from people with Alzheimer’s disease. They also point to previous research from Taiwan, which found people living in areas with higher air pollution were more likely to get Alzheimer’s disease. They say theoretically these particles could get from air into the brain via the 7) ___ nerve, which carries information about smell from the nose to the brain. The study concluded that “Because of their combination of ultrafine size, specific brain toxicity, and ubiquity within airborne particulate matter, pollution-derived magnetite nanoparticles might require consideration as a possible Alzheimer’s disease risk factor.“.

 

The study is quite limited in what it tells us. We know the researchers found particles of magnetite in all the brain samples studied, but as there was no control group – for example, people without neurodegenerative disease in the UK, or people from a less polluted part of Mexico – we don’t know the significance of the finding. And we don’t know whether brains of people with Alzheimer’s disease are more or less likely to contain magnetite 8) ___ than any other brains. It’s important that scientists investigate these findings further to answer some of these questions. Avoiding pollution is sensible for health reasons if you can manage it – for example, by walking away from the edge of a busy road, or cycling through back streets – but it’s not always possible. Although nothing guarantees that you won’t develop Alzheimer’s disease, there are plenty of things you can do to lower your 9) ___ of the condition:

 

don’t smoke

drink only in moderation

keep physically active

eat a healthy diet

keep an eye on your 10) ___ pressure

stay mentally active

 

Sources: nih.gov/pubmedhealth/behindtheheadlines/news/2016-09-07-pollution-particles-in-the-brain-linked-to-alzheimers-disease/

Maher BA, Ahmed IAM, Karloukovski V, et al. Magnetite pollution nanoparticles in the human brain. PNAS. Published online September 6 2016

 

Reuters video on YouTube: Air pollution and Alzheimer’s Disease

Tiny particles found in brain

 

TED Athens: Air Pollution Pandemic

 

ANSWERS: 1) brain; 2) Alzheimer’s; 3) magnetite; 4) polluted; 5) cortex; 6) air; 7) olfactory; 8) particles; 9) risk; 10) blood

 

Health and Medical History of President Thomas Jefferson

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Thomas Jefferson

 

 

History reminds us that a Gordian knot entangles the science of medicine and the art of politics at this level of power.

 

Thomas Jefferson was the primary author of the Declaration of Independence. At age 33 he was one of the youngest delegates to the Second Continental Congress beginning in 1775 at the outbreak of the American Revolutionary War where a formal declaration of independence from Britain was overwhelmingly favored. Jefferson chose his words for the Declaration in June 1775 shortly after the war had begun where the idea of Independence from Britain had long since become popular among the colonies. He was also inspired by the Enlightenment ideals of the sanctity of the individual as well as the writings of Locke and Montesquieu.

 

Jefferson began his childhood education beside the Randolph children with tutors at Tuckahoe. In 1752, he began attending a local school run by a Scottish Presbyterian minister. At age nine, he started studying Latin, Greek, and French; he learned to ride horses and began nature studies. He was taught from 1758 to 1760 by Reverend James Maury near Gordonsville, Virginia, where he studied history, science, and the classics while boarding with Maury’s family. Jefferson entered the College of William & Mary in Williamsburg, Virginia, at age 16, and studied mathematics, metaphysics, and philosophy under Professor William Small, where Small introduced him to the British Empiricists including John Locke, Francis Bacon, and Isaac Newton. Jefferson improved his French, Greek, and his skill at the violin. He graduated, two years after starting, in 1762. He read the law under Professor George Wythe’s tutelage to obtain his law license, while working as a law clerk in Wythe’s office. Jefferson also read a wide variety of English classics and political works and treasured his books. In 1770 his Shadwell home, including a library of 200 volumes inherited from his father, was destroyed by fire. Nevertheless, by 1773 he had replenished his library with 1,250 titles, and in 1814, his collection grew to almost 6,500 volumes. After the British burned the Library of Congress that year, he sold more than 6,000 books to the Library for $23,950. Though he had intended to pay off some of his large debt, he resumed collecting for his personal library, writing to John Adams, “I cannot live without books“.

 

Jefferson was admitted to the Virginia bar in 1767. At the start of the Revolution Jefferson was a Colonel and named commander of the Albemarle County Militia on September 26, 1775. He was then elected to the Virginia House of Delegates for Albemarle. Jefferson was elected Virginia’s governor for one-year terms in 1779 and 1780. He transferred the state capital from Williamsburg to Richmond, and introduced measures for public education, religious freedom, and revision of inheritance laws. Following victory in the Revolutionary War and a peace treaty with Great Britain in 1783, the United States formed a Congress of the Confederation, to which Jefferson was appointed as a Virginia delegate. Jefferson was sent by the Congress of the Confederation to join Benjamin Franklin and John Adams as ministers in Europe for negotiation of trade agreements with England, Spain, and France. Soon after returning from France, Jefferson accepted Washington’s invitation to serve as Secretary of State. Jefferson had initially expected to return to France, but Washington insisted Jefferson be on his new Cabinet. Pressing issues at this time were the national debt and the permanent location of the capital. In the 1800 presidential election, Jefferson contended once more against Federalist John Adams. Adams’ campaign was weakened by unpopular taxes and vicious Federalist infighting over his actions in the Quasi-War. Republicans pointed to the Alien and Sedition Acts and accused the Federalists of being secret monarchists, while Federalists charged that Jefferson was a godless libertine in thrall to the French. The election was said to be “one of the most acrimonious in the annals of American history“.

 

From age 19 on, Jefferson had a tendency to develop prolonged incapacitating headaches, usually at 7-8 year intervals, usually correlated with stress or grief, complicated by indecision and deeply buried rage:

 

Violent headache for two days after behaving awkwardly in front of a girl he fancied (March 1764, age 20);

Six week headache after his mother’s death on March 31, 1776;

Six weeks of headache soon after arriving, unhappy and homesick, as minister to France in 1785;

While overburdened as Secretary of State, headaches recurred when he learned that a friend had become ill, but recovered (April 1790);

About this time he had a second set of headaches, lasting from sunrise to sunset each day for 6 weeks.

 

Medical historian, John R. Bumgarner MD concludes these were a form of cluster headache, but also believes there was a tension component, as horseback riding offered relief. At age 75 Jefferson wrote: “A periodical headache has afflicted me occasionally, once perhaps in six to eight years for two to three weeks at a time, which seems now to have left me.“

 

Other Illnesses:

 

Jefferson was inoculated against smallpox. He himself inoculated his own family — a procedure not to be taken lightly. In late June 1781,

Jefferson (apparently) broke his arm after being thrown from his horse.

Jefferson also broke his wrist in Paris in summer 1785. This seemingly minor event was to cause him grief the remainder of his life. There are three versions of the incident: (1) He was trying to jump a fence while touring Paris with a married woman, (2) He was trying to jump over a kettle, and (3) He fell while walking with an (unidentified) friend. One account described the fracture as compound and poorly treated by the Parisian doctors. The wrist remained swollen, painful, and useless for weeks. Despite taking the waters at Aix-en-Provence, it remained deformed and bothered him the rest of his life.

Jefferson developed severe dysentery (bloody diarrhea) in 1802. He consulted no doctor, feeling that horseback riding helped. (This seemed to be Jefferson’s cure-all therapy.

After performing extensive manual labor at Monticello (his estate) in late summer 1794, Jefferson became almost totally disabled by a back condition for two and a half months. The nature of the problem is not fully known. Repeated bouts of back pain assailed Jefferson after this initial episode, e.g. in 1797.

Jefferson’s back problems, financial troubles, and personal vicissitudes depressed him ca. 1793-1797. He believed his physical health was so poor that death was near.

A severe jaw infection occurred in January 1808. Bumgarner believes this was most likely due to a decayed and infected tooth, but Jefferson’s 1819 statement that he had never lost a tooth to age gives pause.

From “middle age on“ Jefferson required spectacles to read. In his 70s he wore spectacles at night “but not necessarily in the day unless in reading small print“

Jefferson was disabled by “’rheumatism“ in summer 1811. Again, the exact nature of the illness is obscure. It may have been related to his back problems. In 1818 he had his most severe attack of rheumatism ever. It was accompanied by life-threatening constipation. Taking the waters at Warm Springs, VA helped the rheumatism.

In the third week of taking the waters at Warm Springs (1818) Jefferson developed boils on his buttocks. (The 50+ mile ride to the spa plus possibly unsanitary conditions there may have predisposed to the illness.) As may be imagined, his homeward return ride was a trial. Once home, for several weeks he conducted his correspondence lying down. He did not ride a horse for several months. “Jefferson always believed that this experience had greatly injured his health“

Jefferson fell from a broken step at home in 1821 (age 75), fracturing his left arm and wrist. Now both wrists were significantly impaired. He wrote less, even into 1822.

In 1819 (age 75) he was “too feeble to walk much but riding without fatigue six to eight miles per day, and sometimes thirty or forty.“ Comment: This seems like a remarkable dissociation between exercise tolerance while walking and while sitting. Medical speculation: Jefferson may have had spinal stenosis, because these patients are limited in their walking, but may have much better capacity for bicycling and other forms of exercise when seated. Jefferson had a history of back problems.

Jefferson’s strength declined further in winter 1822, but he remained in generally good health. (He dreaded the winters at this age.) He could walk “only [to] reach my garden, and that with sensible fatigue“

In 1819 Jefferson wrote “My hearing is distinct in particular conversation, but confused when several voices cross each other, which unfits me for the society of the table“ (This experience is a classic manifestation of high-frequency hearing loss.) By 1825, however: “This [hearing] dullness of mine causes me to lose much of the conversation of the world and much a stranger to what is passing in it“ It’s possible, that Jefferson’s fondness for shooting as a form of exercise caused the hearing loss.

There are statements (without a description of symptoms) that Jefferson had prostatic enlargement in at least the final year of life.

At age 75 Jefferson wrote: “I have not yet lost a tooth to age“

Asperger Syndrome?  It has been postulated that Jefferson had Asperger Syndrome, a type of autism compatible with high achievement. Distinguishing disease from eccentricity is very difficult 200 years out.

Slept propped up in a bed that was otherwise too short for him. (heard on a tour of Monticello around 1990.)

Jefferson became comatose on July 2, 1826. On the third he awakened and asked, “Is it the fourth?“ He died 50 minutes into the next day, the 50th anniversary of the Declaration of Independence, a few hours before his onetime rival John Adams. Adams’ last words, “Thomas Jefferson still survives“ were mistaken.

 

Other things about Jefferson:

 

As he aged, his red hair turned sandy, then white.

He did not use tobacco in any form.

He started the custom of a President shaking hands, rather than bowing, to greet guests.

The following description of Jefferson is a reminder that medical skills in that era were not always restricted to medical people: “He was a gentleman of thirty-two who could calculate an eclipse, survey an estate, tie an artery, plan an edifice, try a cause, break a horse, dance a minuet, and play the violin“

No significant illness as infant or child.

 

Bumgarner quotes at length from a letter in which Jefferson gave his views on physical fitness. Jefferson encouraged exercise, walking and shooting most of all, observing: “Games played with the ball and others of that nature are too violent for the body.“ Although a dedicated scholar, Jefferson advocated time to exercise even though it meant interrupting study, warning: “Health must not be sacrificed to learning.“ Unfortunately, it appears that Jefferson’s fondness for shooting damaged his hearing.

 

Writing to a physician in 1819, Jefferson described his health and health habits, including:

 

Ate little animal meat. Vegetables were his principal diet.

Drank 3 glasses of wine a day, but “halved the effects“ by drinking only the weak wines. Did not drink “ardent wines“ nor “ardent spirits“ in any form. He did consume “malt liqueurs and cider“ as his “table drink.“

Slept from 5 to 8 hours nightly. Always rose with the sun.

Had few chest colds (every 8 to 10 years). Partially ascribed this fact to his habit of bathing his feet in cold water every morning.

Had a fever of longer than 24 hours “not above three or four times in my life.“

Jefferson was no fan of the doctors, to the point where he would look upwards for a buzzard whenever he saw three physicians together. He especially distrusted the practice of bleeding and purging.

But Jefferson was not above practicing medicine himself. His “practice“ included: suturing the wound of a severely bleeding slave, inoculating his family against smallpox, and treating his daughter’s typhoid fever (with Madeira wine). He used the Madeira regimen on dozens of his neighbors as well.

Through his mother’s father, Jefferson could claim descent from King Edward I of England.

 

Sources:

 

Dr. John R. Bumgarner graduated from the Duke University School of Medicine in 1988. He works in Grand Junction, CO and specializes in Radiology and Vascular & Interventional Rad.

 

1.               Bumgarner, John R. The Health of the Presidents: The 41 United States Presidents Through 1993 from a Physician’s Point of View.

2.               Dallek, Robert. An Unfinished Life: John F. Kennedy 1917-1963.

3.               Hall, Donald (ed.). The Oxford Book of American Literary Anecdotes

4.               Ledgin, Norm. Diagnosing Jefferson: Evidence of a Condition that Guided his Beliefs, Behavior, and Personal Associations.

5.               Montgomery-Massingberd, Hugh (ed). Burke’s Presidential Families of the United States of America

6.               Stern, C. C. Braddock’s Presidential Trivia

7.               Ling and Duff. Pocket Guide to Obstetrics and Gynecology : Principles for Practice

8.               Ostergard et al (ed.). Ostergard’s Urogynecology & Pelvic Floor Dysfunction

9.               NIH.gov, Pubmed

10.            Wikipedia

 

Extreme Temperatures Could Increase Preterm Birth Risk

 

A pregnancy is considered full term at between 39 and 40 weeks. Preterm birth occurs before 37 weeks of pregnancy and increases the risk for infant death and long term disability. It is unknown why extremes of hot or cold might influence preterm birth risk.

 

As a result, a study published in Environmental Health Perspectives (August 2016), assessed whether extreme hot or cold temperatures during pregnancy may increase the risk of preterm birth. The study found that extremes of hot and cold during the first seven weeks of pregnancy were associated with early delivery, and that women exposed to extreme heat for the majority of their pregnancies also were more likely to deliver early. The authors found more consistent associations with early delivery after exposure to extreme heat than to extreme cold weather. They theorized that, during cold spells, people are more likely to seek shelter and so could more easily escape the cold’s effects. But during extreme heatwaves, people are more likely to endure the temperature, particularly when the cost of or access to air conditioning is an impediment. The authors theorize that the stress of temperature extremes could hinder the development of the placenta or alter blood flow to the uterus, both of which could potentially lead to early labor.

 

To conduct the study, the authors linked electronic medical records from 223,375 births at 12 clinical centers throughout the United States to hourly temperature records for the region surrounding each center. The authors noted that what constitutes a hot or cold temperature varies from person to person and place to place. To compensate for local climate variability and personal susceptibility, the authors evaluated temperatures in the surrounding regions. They defined extreme cold temperatures as below the 10th%ile of average temperatures, and defined extreme heat as above the 90th%ile. The study found that women who experienced extreme cold for the first seven weeks of their pregnancies had a 20% higher risk for delivering before 34 weeks of pregnancy, a 9% increased risk for delivering from 34-36 weeks, and a 3% increased risk for delivering in weeks 37 and 38. Women whose first seven weeks of pregnancy coincided with extreme heatwaves had an 11% increase in risk before 34 weeks, and a 4% increased risk at 37 to 38 weeks. Exposure to extreme heat during weeks 15-21 increased the risk for delivery at 34 weeks and at 34-36 weeks by 18% and for delivery from 37 to 39 weeks by 4%. Hot exposures during weeks 8-14 increased the risk for birth at 37 to 38 weeks by 4%. Overall, exposure to extreme heat for the duration of pregnancy was associated with increases in risk for delivery at 34 weeks and 36-38 weeks by 6 to 21%.

 

According to the authors, an increase in the number of extreme hot days due to climate change could lead to increases in the preterm birth rate. The authors added that their findings underscore the need for health professionals and policy makers to devise interventions for minimizing pregnant women’s exposure to extreme temperatures. The authors also called for more research to understand how temperature extremes might increase preterm birth risk.

 

Otulipenia, A New and Rare treatable Inflammatory Disease

 

Editor’s note: The following shows the exciting intersection of basic research and the pharmaceutical industry. It is time to bring back safe drugs to patients who need them. Remember, we will all be a patient at some time.

 

Otulipenia is one of several inflammatory diseases that occur when the immune system attacks the host’s own tissues. Inflammation is the body’s natural response to invading bacteria or viruses. The body releases chemicals that cause blood vessels to leak and tissues to swell in order to isolate a foreign substance from further contact with the body’s tissues. Inflammatory diseases affecting the whole body are caused by mutations in genes like OTULIN that are part of a person’s innate immunity (the cells and proteins present at birth that fight infections.   Otulipenia is caused by the malfunction of OTULIN, a single gene on chromosome 5. When functioning properly, OTULIN regulates the development of new blood vessels and mobilization of cells and proteins to fight infection.

 

According to a publication in the early edition of the Proceedings of the National Academy of Sciences (22 August 2016), a new and rare and sometimes lethal inflammatory disease — otulipenia — that primarily affects young children, has been discovered. Fortunately, anti-inflammatory treatments that ease some of the patients’ symptoms: fever, skin rashes, diarrhea, joint pain and overall failure to grow or thrive, have also been identified.

 

The results have been amazing and life changing for these children and their families,“ said Daniel Kastner, M.D., Ph.D., co-author and NHGRI scientific director and head of NHGRI’s Inflammatory Disease Section. “We have achieved the important goal of helping these young patients and made progress in understanding the biological pathways and proteins that are important for the regulation of the immune system’s responses.“

 

For the study, an international network of scientists studying inflammatory diseases identified four children from Pakistani and Turkish families with unexplained skin rashes and inflamed joints. The authors then searched for disease-causing genes usingnext-generation DNA sequencing technology that allows researchers to sequence DNA quickly and economically. Once it was found that the OTULIN gene was abnormal in the sick children, the immune pathways was studied in order to understand the mechanisms of disease and to improve treatment of these patients. When doing this, the authors discovered a problem in the processing of a small protein, ubiquitin, which is critical to the regulation of many other proteins in the body, including immune molecules. In the affected children, the inability to remove the ubiquitin proteins from various molecules resulted in an increased production of chemical messengers that lead to inflammation (inflammatory cytokines).

 

The authors determined that the children with otulipenia might respond to drugs that turned off tumor necrosis factor, a chemical messenger involved in systemic inflammation. Inflammation subsided in the children who had been treated with anti-tumor necrosis factor drugs (TNF inhibitors). TNF inhibitors are also used to treat chronic inflammatory diseases such as rheumatoid arthritis. This study together with NIH’s 2016 identification of haploinsufficiency of A20 (HA20), suggests a new category of human inflammatory diseases caused by impaired ubiquitination.

 

FDA and Illegal Sales of e-Cigarettes, e-Liquids, Cigars to Minors

 

The FDA has announced that it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions.

 

Retailers play a vital role in keeping harmful and addictive tobacco products out of the hands of children and FDA is urging them to take that responsibility seriously. According to FDA, it’s clear from these initial compliance checks that there’s a need for strong federal enforcement of these important youth access restrictions. For example, during compliance checks at major national retail chains, tobacco specialty stores and online retailers, minors were able to purchase some of these newly regulated tobacco products in a variety of youth-appealing flavors, including bubble gum, cotton candy and gummy bear.

 

Before the final rule that extended the FDA’s authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others, there was no federal prohibition on the sale of these products to children, contributing to skyrocketing use by youth. Data from the FDA and the Centers for Disease Control and Prevention show current e-cigarette use among high school students increased by more than 900% between 2011 and 2015, and hookah use also increased significantly during this time. Additionally, data show high school boys smoked cigars at about the same rate as cigarettes. The rule, which went into effect on Aug. 8, allows the FDA to protect future generations from the dangers of tobacco use through provisions aimed at restricting youth access. As part of the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA closely monitors retailer compliance with federal tobacco laws and regulations and takes corrective action when violations occur. The agency, on its own or through contracts, conducts inspections in 56 states and territories. When violations are found, the agency generally issues warning letters before it pursues enforcement actions, including civil money penalties and no tobacco sale orders. Since 2009, the FDA has conducted more than 660,000 inspections of tobacco product retail establishments, issued more than 48,900 warning letters to retailers for violating the law and initiated more than 8,290 civil money penalty cases.

 

The FDA’s tobacco compliance and enforcement program works to ensure that industry and retailers follow existing laws designed to protect public health. To help retailers of tobacco products understand how to comply with federal regulations, the FDA provides compliance education and training opportunities to retailers. Consumers and other interested parties can report a potential tobacco-related violation of the Federal Food, Drug, and Cosmetic Act, including sale of tobacco products to minors, by using the FDA’s Potential Tobacco Product Violation Reporting Form.

 

Corn & Hummus with Spinach, Red Pepper & Chicken

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If you were at a loss, as to what to have for dinner, how about a finger-full, of all the tasty nutrition requirements in one meal? In just one bite, you get spinach, corn, red pepper, hummus, cilantro, low-cal breast of chicken and the small amount of carbs from the tortilla. You decide if you want to cook the chicken, red pepper, red onion in low sodium chicken broth, or olive oil. To these yummy tidbits, add your favorite chilled white wine and you have a meal. This is what we did one evening, this past week. We did add, to the table, an extra bowl of garlic hummus, to dip our tasty tortilla morsels in. We were satisfied and happy as clams. Kids will like this too. ©Joyce Hays, Target Health Inc.

 

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Before dinner, also consider serving this finger food as an appetizer with icy white wine (or beer). Such

a versatile recipe, it can be a snack or lunch or on a brunch buffet table. ©Joyce Hays, Target Health Inc.

 

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Couldn’t be healthier. ©Joyce Hays, Target Health Inc.

 

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About two luscious bites in each. ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

2 or more rounds of tortillas (make your own or use store-bought)

4 ears corn, kernels scraped off

2 large garlic cloves, squeezed into the bowl with garlic hummus & other ingredients

1 red onion, sliced

6 black olives sliced thin

2 containers of garlic hummus

Pinch Paprika

Pinch salt

Pinch black pepper

Pinch chili flakes

2 or more pieces of cooked chicken, then shredded (thigh and/or breast)

4 or more red peppers, cooked in olive oil until soft or cooked in chicken broth

1 container baby Spinach, washed two times and dried with paper towel. Chop it but not too much

1/2 cup fresh cilantro, well chopped

Olive oil for cooking

 

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Ingredients. ©Joyce Hays, Target Health Inc.

 

 

Directions

 

Cook the chicken, red pepper and onion in a pan with olive oil, and/or chicken broth Take red pepper and onion slices out of pan as soon as they’re soft. Let drain on paper towel. Cook the chicken longer, until there is no pink meat left, when you make a cut.

 

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Cooking the chicken, red peppers, red onions in low sodium chicken broth with a tiny amount of

olive oil. If you want to eliminate the olive oil, that also works.©Joyce Hays, Target Health Inc.

 

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Here, on edge of sink, I’m draining the cooked red peppers. ©Joyce Hays, Target Health Inc.

After chicken is cooked, pull it apart so that you have shredded pieces of chicken. Set aside

 

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Pull your cooked chicken apart in shreds, so it’s easy to sprinkle onto the tortilla.

©Joyce Hays, Target Health Inc.

 

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Put the ingredients in a bowl, so they’re ready to place. ©Joyce Hays, Target Health Inc.

 

 

Wash the spinach twice and dry with paper towel. Wash it, even though it may come in a sealed plastic bag. Don’t take a chance and skip the two washings.

 

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Fresh tender, baby spinach. ©Joyce Hays, Target Health Inc.

 

In a bowl, squeeze the 2 garlic cloves into the hummus. To the bowl of hummus, add all the spices and the cilantro and mix everything together, until well combined.

 

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All hummus is in a bowl, I’m mixing extra garlic in, as well as all the spices. ©Joyce Hays, Target Health Inc.

 

 

Place the flat bread or pita on a cutting board.

Spread hummus mixture, all over the surface of flat bread or pita.

 

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First step, spread the hummus all over the tortilla. This is only the beginning. More hummus will

be slathered onto the tortilla. ©Joyce Hays, Target Health Inc.

 

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Next, add the chicken, spinach, corn, close to the center of the circle, not near the edges.

©Joyce Hays, Target Health Inc.

 

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Finally, do NOT add a big chunk of red pepper, as you see, above. I found out by trial and error,

that unless you cut thin strips of red pepper and add a few of these red strips, when you roll the

tortilla up, it may crack, from the mass of the pepper. ©Joyce Hays, Target Health Inc.

 

 

Add the shredded chicken to the center of the pita

Cut the soft red pepper in thin strips so it fits easily near the center of the pita

Add the slices of cooked red onion, near the center of the pita

Add the raw baby spinach to the center of the pita

Add the raw corn kernels to the center of the pita

Add slices of black olives

Pick up one side of the pita and roll it. Make sure the roll is tight. If you don’t roll the pita or flatbread very tight, your pinwheels will come apart, on the serving plate

 

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Roll up tightly. ©Joyce Hays, Target Health Inc.

 

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To help keep the edge of the pita in place, add some hummus to the edge. This should help it stick together. ©Joyce Hays, Target Health Inc.

 

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With a sharp knife, cut the roll into 8 slices. Use toothpicks, if needed to secure.

©Joyce Hays, Target Health Inc.

 

 

Store pinwheels in the fridge in an air tight container

Put the roll and/or the pieces in foil, and then in the fridge

Serve as an appetizer or snack or side dish

 

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Instead of a salad, we nibbled on fresh veggies. Look at the beautiful cherry tomatoes and purple cauliflower I got from FreshDirect. I’m planning a recipe with their purple, yellow, green and white cauliflower. ©Joyce Hays, Target Health Inc.

 

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Fresh Veggies. ©Joyce Hays, Target Health Inc.

 

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For us, this was a feast of flavors. ©Joyce Hays, Target Health Inc.

 

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Is your mouth watering? ©Joyce Hays, Target Health Inc.

 

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This was a lovely chilled wine with the corn & chicken tortilla appetizers. ©Joyce Hays, Target Health Inc.

 

 

From Our Table to Yours !

 

Bon Appetit!