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s s e c o r P l a v o r p p A A D F e h t f o s C B The A

737 Main Street Suite 100 Buffalo, NY 14203 (716) 883-1833 (855) 836-2676 www.milestoneseventh.com


Dear Friends, For more than 15 years, our team has partnered with plaintiffs’ attorneys throughout the U.S. In that time, we have come to appreciate the challenges inherent to contingency fee practices.


John T. Bair editorial editor-in-chief

In addition to specializing in attorney fee deferrals for tax planning and wealth building, at Milestone we have a robust Medicaid planning and Special Needs trust practice.

Stephanie Andre sandre@livingsafer.com

a s s o c i at e e d i t o r

Brittany Monbarren bmonbarren@livingsafer.com

art director

Eva Talley etalley@livingsafer.com

With more than 1,000 cases of experience, we can guide you and your client through a vital education. Settlements as small as $50,000 demand an intimate knowledge of the pooled special needs trust space. Rely on our team to assist your client in understanding state level options, as well as a few national trusts. Significant settlements that net your client $300,000 or more require knowledge and expertise in reliable elder law attorneys, independent professional trustees, and a dedicated settlement planner. Whether court approval is necessary or not, having a trusted expert in the driver’s seat for this planning is an important part of your advocacy for your client. Enjoy the “ABC’s” included in this issue of Living Safer. Sincerely,

John T. Bair Founder/Member Milestone Consulting, LLC Toll Free: 855.836.2676 www.milestonesventh.com

i n l i f e , t h e r e c o m e s a t i m e t o m o v e f o r wa r d t o t h e n e x t m i l e s t o n e

Inside This Issue ON THE COVER

The ABCs of the FDA Approval Process It’s so easy to say, “Sure, I can take this medication. It must be safe. The FDA approved it.” But is that the reality? Addiction numbers continue to rise, and pill mills run through prescription pads like kids with candy. Given this, it’s easy to become cynical and concerned that perhaps part of the blame falls to the governing agency — the one that put these medications in our palms at the start: The Food and Drug Administration.
















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The Skinny on Spring Cleaning Do Your Research

Little Known Pet-Cleaning Fun Fact

‘Tis the season to clean out the cobwebs—and the garage. Before you get down and dirty, be sure to check out cpsc.gov—that stands for Consumer Product Safety Council. There, you’ll be able to check for the latest recalls and safety concerns about the products you may be using. Take a peek before you head out on your spring cleaning shopping spree.

A window squeegee does a great job at removing pet fur from carpets and furniture. Pet hair from dogs and cats can be hard to remove once it has become embedded in the fibers—even with a vacuum. The solution? A simple window squeegee. Use the rubber blade to rake up the pet hair. Once most of the pet hair has been successfully removed, a vacuum should be able to finish the job.

Maximize Your Space A recent Liberty Mutual Insurance survey found that 33% of Americans said that the most organized room in their house is the living room while the least organized room is, you guessed it, the garage. When you consider that the garage contains many of the most expensive items in the house (cars, bikes, skis, tools, etc.), this seems like an especially bad area to neglect. Furthermore, when properly organized, the garage provides significant storage space in the home. Take the time; it’s worth it.

A New Reason to Recycle You’d never think it’s true that a sheet of paper covered in ink could clean anything, but it has been a contractor’s trick for years. Using newspaper on windows to clean glass leaves no streaks, is absorbent and easy to maneuver around the window. The lack of lint on newspaper (vs. paper towels or an ordinary cleaning cloth) is the key.

– Stephanie Andre

Write Those Lists For closets and especially your garage, take the proper time to your items. Use an app (see next page) that lets you store images and information, such as purchase price and date for each item on your phone.

Bleaching Myths The notion that bleach effectively cleans flooring, countertops and fixtures is a myth. You must first clean, then disinfect with bleach or a similar product. Without first removing the dirt and food particles, germs can linger even with a bleach application. Likewise, without using a disinfectant, germs can linger.



Spring Cleaning for the

Tech Lover

Spring cleaning can be a daunting task, especially if you’ve slacked a little on cleaning throughout the year. However, with the help of some handy cleaning apps and gadgets, your home will be sparkling in no time and you’ll be able to keep your house in tip-top shape any time of the year!



This app is perfect for the DIY lover. With BrightNest you can fix things on your own. It’s filled with a variety of home maintenance and design guides and tutorials to assist you. The app is also filled with cleaning and home organizational tips.

Similar to the Think Dirty app, GoodGuide lets you search or scan a database of more than 250,000 products across multiple categories to help you determine whether the products are safe, healthy, green and ethical products. You can search for a household cleaning product and get information on the ingredients and ratings based on health, environmental and social impact.

Think Dirty


Think Dirty is the easiest way to learn about the potentially toxic ingredients in your cosmetics and personal care products. Just scan the product barcode and Think Dirty will give you easy-to-understand info on the product, its ingredients, and shop cleaner options!

Get the entire family in on the spring cleaning fun. Chorma is an easy (and fun) way to organize tasks within the household. The app syncs between devices allowing you to have the option to assign everyone with a specific task and it lets everyone see the assigned list. Once a task is complete, the app with automatically update.



After decluttering, you’ll need to find somewhere to take those unwanted items. iRecycle by Earth911, Inc. helps you find accessible recycling venues in your area. The app also have a ton of different ways to recycle material, perfect for the DIY-er.

Cleaning isn’t so bad when it’s done on a regular basis. Once you’ve finished with spring cleaning, this app is a must-have! HomeRoutines helps you create a routine for your home cleaning tasks. You can schedule morning, evening and weekly tasks and the app will send you reminders. Next year, your spring cleaning will be more like a quick wipe down thanks to HomeRoutines!



iRobot Scooba While you’re tackling one task, the iRobot Scooba Floor Scrubbing robot can tackle another. This nifty little gadget tackles stuck-on messes so you don’t have to. The Scooba technology finds its way around the room and sweeps, pre-soaks and squeegees your hard floors.

WINBOT No more dangerous ladders. No more paper towels. No more spraying. Winbot Window Cleaning Robot by Ecovacs is today’s solution to window cleaning. This gadget cleans framed and unframed glass, windows and mirrors with just the touch of the button.

CleanWave The CleanWave Sanitizing Wand is a convenient, all-in-one sanitizing solution for your home or office. This little gadgets eliminates 99.99% of germs, viruses, bacteria, allergens, and flea and dust mite eggs from any household surface and deodorizes upholstery, carpets and fabrics.

iRobot Looj Let’s face it, gutter cleaning is not fun. Plus, it’s dangerous climbing up and down, and reposition the ladder every few minutes or so. With the iRobot Looj Gutter Cleaner, you just put the ladder in one spot and the robot will do the rest. It takes a tedious, dangerous task and makes it bit easier and much safer.

Bruno Bruno is the world’s first “smartcan” that combines the kitchen trashcan and a vacuum system. This smartcan has a motion sensing lid and an integrated vacuum feature to catch every grain of dirt from the floor directly into the trash bag. Bruno also has an app that will remind you take the trash out on trash day and alert when you are low on bags.

– Brittany Monbarren



When It Comes to Fitness,

CONSISTENCY is the Name of the Game by Rick Bradley


et’s face it, working out is not at the top of most peoples’ list of favorite things to do. Still, the benefits of physical fitness and activity are undeniable. For years, the U.S. government has gone to great lengths to develop guidelines in regard to physical fitness in the hopes that Americans will live less sedentary lives. Despite the efforts of the federal government and the fitness industry, approximately 80% of all Americans fall well below the minimum recommended levels of physical activity as promulgated by the federal government. Presently, the President’s Council on Fitness, Sports & Nutrition suggests that adults ages 18-64 partake in 30 minutes of physical activity per day. This may not sound like a significant undertaking, but we live in a sedentary society in which 30 minutes of physical activity is seldom achieved yet four hours of daily television consumption is the norm, according to the Bureau of Labor Statistics. I have spent the better part of 30 years searching for a solution to the American sedentary lifestyle in the hopes of improving the overall physical fitness of the 80% of Americans that take part in no physical activity at all on a regular basis. The benefit of physical activity and a healthy lifestyle are beyond repute. Increased physical activity leads to better cardiovascular health which in turn decreases the risk of heart attack, stroke, and a litany of other preventable and deadly diseases. Furthermore, physical activity also allows us to live longer, healthier lives and to truly enjoy all life has to offer. My research and the common sense studies from countless medical journals and physicians had lead me to preach the maxim, “Movement leads to Improvement.” Again, none of this is breaking news and the premise of daily physical activity is easy to understand—yet difficult to practice. In an effort to ameliorate the epidemic of obesity and failing cardiovascular health presently plaguing our country, I developed the simplest, and easiest to follow fitness program I could and Quick Fit was born.


Quick Fit is a 15-minute workout program that combines of aerobic activity, strengthening exercises and stretching, and can be done at home or at work; the Quick Fit exercise program is designed to get people moving—one small step at a time—toward a healthier life. The premise of the program is that for the vast majority of Americans who do not work out at all, simply adding 15 minutes of exercise to your daily routine will have monumental results. The best part is that Quick Fit can be performed anywhere and without even breaking a sweat. I have been in the exercise filed since the late 1980s when I began my career as the flexibility coach for the Washington Redskins. Since that time, I have come to believe strongly that fitness should be simple, so as to allow individuals to be consistent. I believe, and studies have shown, the best exercise in the world is the one you can do consistently. In the regular columns that follow, I will focus on breaking down some of the more perplexing questions concerning health, nutrition and fitness as well as sharing some of the amazing success stories that I have heard from thousands of regular Americans. So now that we have established the groundwork, let’s take a look as to just why consistency is so important in maintain a healthy lifestyle. The human body is adaptive and constantly geared toward habit and routine. Simply put, if we insert healthy habits into our daily life these become routine and the result is increased health and happiness. We are designed to be creatures of habit and by inserting even a nominal amount of physical activity to our routine—as little as 15 minutes—the progress toward healthy living is immediate and cumulative. Like money in the bank, it is cumulative. It all adds up. People ask me, “Can Quick Fit provide all the beneficial effects of exercise programs that call for longer and more strenuous workouts?” I tell them: “It depends on whether you’ll actually do those workouts.” Think of the bank again. If you deposit $15 a week, your balance won’t be as high as if you deposit $30 a week. But a consistent $15 per week beats an irregular $30 every month or so—and it’s a whole lot better than nothing. That’s true for exercise, too. Unfortunately, the folks who need to exercise the most can’t (or won’t) work out 30+ minutes a day, month after month, year after year. They resolve to exercise on Jan. 1; they buy a treadmill on the cable TV shopping channel. Then a couple of months later, they’ve quit and they’re using the treadmill as a coat rack. But lifelong fitness requires consistency. This is why I say, consistency is the name of the game. Fitness expert and motivator Richard R. “Rick” Bradley III is the creator of the Quick Fit exercise program and the author of “Quick Fit: The Complete 15-Minute, No-Sweat Workout.” Bradley’s program have been featured in The Washington Post and he has appeared on NBC’s “Today,” C-SPAN, PBS’ “America’s Walking” and the Voice of America broadcast. He now hosts his own radio show, “Fit Feds,” on Federal News Radio (WFED AM 1050 in the Washington, D.C. metropolitan area), where he discusses all aspects of health and fitness. Bradley was also the director of the Occupational Health and Fitness Program at the U.S. Department of Transportation for 27 years.


The Zika Virus:


What’s Fact? What’s Fiction? by Lily Grace


ith the emergence of the Zika virus, many are fearful of mosquitoes—but without the facts. From unborn babies and transmission to vaccines are more, here we cover what you need to know.

The Zika virus is carried by mosquitoes and people, but 1 usually spread by mosquitoes. Zika is an RNA virus related to the West Nile, yellow fever and dengue viruses, and caused by the bite of the Aedes mosquito. These viral diseases have mosquitoes as their vector—the bug or organism that transmits an infection—and are generally not passed from person to person, explains Peter Jay Hotez, MD, PhD, dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston. As a safety measure to protect the blood supply and transplant recipients, the FDA recommends not donating blood, tissue, or organs if, within the last six months, you’ve been diagnosed with the Zika virus, have been in an area with active Zika virus, or had sex with a man who’s had the virus or been in a Zika hot spot. The Zika virus can also be sexually transmitted. A person in Texas became infected after having sex with someone who had traveled abroad, according to local health officials. Symptoms of Zika virus infection are usually mild. Eighty percent of people who become infected never have symptoms. In those who do, the most common Zika virus symptoms are fever and rash; it can also cause muscle and joint pain, headache, pain behind the eyes, and conjunctivitis (itchy, red eyes), according to the World Health Organization (WHO). Health experts note that symptoms generally last two to seven days. No effective treatment is available for Zika infection, but over-the-counter fever or pain medication can be helpful.


Unborn babies are most at risk from Zika virus complications. When pregnant women are infected with Zika, the unborn child is at risk, says Hotez. “We’re seeing illness when it strikes women who are pregnant, and it’s producing a horrific effect of microcephaly,” he says. Microcephaly may cause mental retardation, as well as delays in speech, movement, and growth, according to the Mayo Clinic.


in the Zika forest in Uganda. Researchers there found that it lived in mosquitoes, and they learned through experimentation that it could also infect mice. Zika has reached Puerto Rico’s mosquitoes and may keep traveling north.“Puerto Rico has reported the first locally-acquired Zika virus case in the United States,” says Benjamin Haynes, a CDC spokesperson. The case was reported in December 2015.


U.S. travelers are bringing the viral disease back with them. These imported cases happen when a person is infected elsewhere and then visits or returns to the United States. To date, the CDC has reported 193 travel-linked cases of Zika in U.S. states and 173 cases of local infections in U.S. territories.


Travelers probably won’t bring infected mosquitoes along with them. “It’s extremely unlikely that mosquitoes would be carried back to the United States by citizens traveling abroad,” says Jim Fredericks, PhD, chief entomologist and vice president of technical and regulatory affairs for the nonprofit National Pest Management Association in Fairfax, Virginia.


You can help prevent Zika infection by using insect repellents. “The best way to avoid mosquito bites is to use a repellent containing picaridin, oil of lemon-eucalyptus, at least 20 percent DEET, or IR3535 when venturing outdoors, especially near dawn and dusk when mosquitoes are most active,” says Dr. Fredericks.


Mosquito control can help prevent Zika. Controlling the insect vector by cutting down on mosquito breeding is one way to prevent spread of this and other mosquito-borne viruses. Breeding sites include water-filled habitats like plant containers and toilets inside the home, and puddles, birdbaths, and pooled water outdoors. Chemical pesticides can kill mosquitoes, but use them carefully to prevent contamination that could be harmful to your health, notes the CDC.


There’s no vaccine to protect against the Zika virus. “There’s going to be a need to accelerate a Zika vaccine,” says Hotez. “I think the world got caught by surprise at the congenital infections. Now there’s going to be a lot of interest in a vaccine for women of reproductive age, like the rubella vaccine [to prevent birth defects].”



Zika began in Africa and spread rapidly. The virus, originally named ZIKV, was first discovered in 1947 in a rhesus macaque


Miscarriage is Not a Dirty Word by Edward L. Graham


fter the devastating emotional pain of a miscarriage, the natural human response is guilt—on many levels—and fear of a similarly horrific outcome from the next pregnancy. This article seeks to provide reassurance, encouragement and suggestions. Some of the most powerful human emotions are guilt and fear. After a pregnancy loss, a woman suffers guilt and fear that something must be wrong with her body, or that her actions caused the loss; that her next pregnancy will thus be doomed to failure; and that another agonizing loss would be unbearable. She is understandably afraid to get pregnant again. Such fears usually affect the spouse or partner as well. Either or both parents may experience physical manifestations of their fear and anxiety, such as reduced libido, erectile dysfunction, difficulty getting aroused or irregular menstruation. Guilt feelings include not only blaming oneself for the loss, but also blaming oneself for wanting to get pregnant again, as though that somehow “dishonors” the deceased child. There may be guilt, fear and self-doubt about whether one can or should get pregnant again. If there is another pregnancy, the pain of the prior loss and fear of another causes emotional detachment from the new fetus, as a selfprotective mechanism. Bonding with the new life is often impaired, especially early in pregnancy, through the prior date of loss. There may be feelings of guilt for feeling joy, for not feeling joy, or for being emotionally detached.


You’re Not Alone If you have suffered a pregnancy loss, know that your loss is not a rare occurrence. An estimated 15-25% of confirmed pregnancies end in miscarriage, prior to 20 weeks gestation. Fewer (around 1 in 160-200) are lost after 20 weeks, when the loss is defined as a stillbirth. Nearly half of all women experience a pregnancy loss sometime during their lives. Know also that there is no “correct” way to respond emotionally to the loss. Potential human responses vary dramatically. There may be smooth and easy acceptance for a few. For many, there will be a normal grieving process, with progression from shock and denial—to pain and guilt, anger, bargaining, depression, reflection, loneliness, an upward turn, reconstruction and working through— toward eventual acceptance and hope. Yet some will experience profound mental health conditions that persist and require professional intervention. Those may include clinical depression, anxiety, post-traumatic stress disorder and obsessive-compulsive disorder. Clinical depression is more likely in younger women, women with a prior loss, and women with prior depression. The rate of clinical depression does not vary based on the number of living children, marital status, ethnicity or education level. Please seek professional help as needed for any persistent mental suffering you may experience. Whatever your emotional response to your loss, do not blame yourself for your particular individual reaction. Your reaction is influenced not only by your personal emotional makeup, but also by the hormonal changes of pregnancy, which can significantly affect your brain chemistry. Do not feel pressured to gloss over or forget about your loss.


Let Your Voice Be Heard Powerful emotions are at times bewildering to the one experiencing them, as well as to one’s loved ones. Find support from true friends, but minimize contact with those whose comforting skills need improvement. Well-intentioned loved ones may find themselves so fearful of saying or doing the wrong thing—thereby making matters worse—that they become insecure and inhibited about providing beneficial support. Tell them what you need from them. If you and your spouse or partner are grieving in different ways, respect the differences and give each other time and space to heal without being resentful. Consider a support group, or talking with someone who has suffered a similar loss. Do not let anyone (including yourself) over-analyze your emotional responses, as the emotions of grief, anger and depression can express themselves in unexpected mood swings. For example, one may quickly change from calm acceptance to tearful despair—from bitter anger to emotional detachment. Triggers for sudden recurrence of grief, anger or depression may range from being around friends and family with young children, to holidays, playgrounds, doctor visits, television commercials, and random encounters with a pregnant woman or young child, among others. Allow and affirm your genuine feelings. A good cry can relieve anxiety. Learn to accept that emotional healing takes time and patience. For many, an important step in dealing with one’s guilt and fear is to learn as much as possible about what caused or may have caused the loss. (For others, that effort is overwhelming, and should be avoided.) Most often, the cause relates to a problem with the embryo or fetus, perhaps a genetic abnormality. Sometimes there is condition known as “blighted ovum,” where a fertilized egg develops a placenta and membrane but no embryo. Other causes are maternal, such as hormonal imbalance, genital tract infection, incompetent cervix or abnormally shaped pelvis. Often the cause remains unknown. Talk openly with your obstetrician about the potential causes of your loss, and what you can do to maximize the chance of a successful outcome next time. Though many potential causes are beyond one’s control, close medical evaluation and supervision can minimize the risk of recurrence. Thus, being labelled “high risk” is a blessing. There is some controversy about when a woman should get pregnant again after a loss. Most believe the parents should come to terms with their loss through the normal grieving process before the next pregnancy. Some physicians believe the woman should get pregnant again as soon as possible. Others recommend waiting as long as 18 months. The World Health Organization recommends waiting six months. A recent study of more than 30,000 women who experienced a miscarriage with their first pregnancy concluded that subsequent pregnancies were more likely to have successful outcomes and with fewer complications if the subsequent pregnancy started within six months of the loss. Even without treatment, 60-70% of women with a miscarriage

go on to have a healthy pregnancy. By working through your grief, seeking medical advice and following the suggestions below, your chances of a successful outcome with the next pregnancy are very encouraging.

Steps to Consider after a Pregnancy Loss For those who want to maximize the chances of a successful outcome after a pregnancy loss, see the following suggestions: »» Lose weight before conception if you are heavy or obese. »» Schedule a preconception medical exam to rule out dangerous infections. »» Enjoy good nutrition. Stop or reduce caffeine intake. Avoid artificial sweeteners. Reduce consumption of seafood. »» If you smoke, stop. »» If you drink alcohol, stop during pregnancy. »» Take folic acid of at least 400 mcg. »» Enjoy regular moderate exercise, but avoid strenuous workouts. »» Communicate regularly with your spouse or partner. »» Make regular visits and maintain close communication with your obstetrician. »» Expect, accept and affirm a jumble of mixed emotions...

excitement, joy, detachment, anxiety, grief, guilt, difficulty bonding. »» Get regular scans to observe progress of embryo and fetus. »» Take each day at a time. Acknowledge and cherish the successful completion of each day. »» Stay positive. Affirm the differences between this pregnancy and the last. Focus on how well you and your baby are doing. »» Minimize over-scheduling and stress. Learn to say no at work, at home, with friends and family. »» Do relaxation exercises. Consider a mantra, like “Stay calm and well for my baby.” »» Engage your unborn baby with comforting talk, song, prayer. »» Get a good night’s sleep. If that is a problem, seek help. »» Consider announcing your pregnancy only after you pass the date of your prior loss. »» Expect your anxieties to abate, and your sense of joy and self-confidence to increase after you pass the date of your prior loss. You will feel more secure about completing your preparations for your growing family. »» After the successful birth, try hard not to be an over-protective parent.nces between this pregnancy and the last. Focus on how well you and your baby are doing.


How Sweet It Is

Maybe you need more

HONEY in your diet by Matthew Casey


re the benefits of honey really as sweet as people claim? Honey is a blend of sugar, enzymes, amino acids, minerals and vitamins. When used in moderation, raw honey has some pretty remarkable health benefits. In fact, humans have used honey for medicinal purposes for more than 2,000 years. So, yes, honey does have a reputation as ‘liquid gold’ with multiple benefits—from suppressing coughs to healing wounds.



Natural Sweetener – Of course, all carbohydrates and sugars should be consumed with moderation. The beauty of substituting honey as a natural sweetener works because it satisfies a sugar craving, but also has the added benefits of minerals, trace enzymes, vitamins and amino acids.

Cough Medicine – To soothe a cough, the World Health Organization recommends using honey because it forms a protective film that coats the mouth and throat to relieve irritation. Honey actually works the same as dextromethorphan, a common ingredient in over-the-counter cough medicine.

Scalp Irritation/Dandruff – Clinical trials have proven that patients with seborrheic dermatitis, a scalp condition that causes dandruff, itching and skin lesions, have seen significant improvement by using a simple solution of honey diluted in warm water.

Reduce Allergy Symptoms – There is no concrete medical data to support the use of honey for allergy relief, however, many people taut the benefits. The theory is that local honey contains pollen spores from local plants. If a person introduces small amounts of these allergens into their immune system, over time their immune system will build up an immunity to the allergens. The key is to consume one teaspoon of locally grown honey every day for several months leading up to peak allergy season.

Energy Boost – Athletes looking for a boost of energy before, during or after a workout need to look no further than raw honey. The natural sugars in honey is perfect for athletes looking for time-released, sustainable energy over a long period of time.

Moisturizer – Honey is a humectant, which means it naturally attracts and retains moisture. This makes it an ideal ingredient for use in moisturizing shampoos, conditioners and lotions.

Treating Wounds – Until the early 20th century and the invention of penicillin, honey was commonly used to fight infections. Honey has antibacterial, antifungal and antioxidants that make it ideal for treating skin infections and wounds. In fact, a specific strain of honey called Manuka honey (made from the medicinal Manuka bush) has been proven to eradicate more than 250 strains of bacteria, including resistant varieties such as, MRSA, MSSA and VRE. Consumers should be aware that not all honey is created equal. Almost 75% of all honey on the market contains additives and is highly processed, to the point that all medicinal properties are absent. When purchasing honey, go to farmer’s markets or natural/health food stores. Read the labels and look for all-natural, unfiltered, locally grown, raw honey from a trusted source. Honey, in any form, is safe for consumption by adults and children over the age of one. Infants under one should not consume any type of honey, as it may contain a bacteria that can cause botulism.

SIMPLE HOME HONEY RECIPES: Honey Hair Conditioner Mix ½ cup honey with ¼ cup olive oil. Work a small amount through your hair until coated. Cover your hair with a shower cap and let sit for 30 minutes. Shampoo as normal and rinse.

Honey Body Moisturizer Mix 5 tablespoons honey, 2 tablespoons rose oil, and 2 cups almond oil in a medium-sized bottle. Apply as needed onto wet skin.

Honey Almond Scrub Mix 3 teaspoons honey, 1 teaspoon olive oil, and 6½ tablespoons of finely crushed almonds. Rub the exfoliating scrub onto your face gently and rinse with warm water.

Honey Lemon Cough Syrup 1. Put a pint of raw honey in a pan on the stove on VERY low heat (Do not boil honey as this changes its medicinal properties).

2. T  ake a whole lemon and boil in some water in a separate pan for 2-3 minutes to both soften the lemon and kill any bacteria that may be on the lemon skin.

3. L et the lemon cool enough to handle then cut it in slices and add it to the pint of honey on the stove.

4. L et mixture cook on warm heat for about an hour.

5. T  hen strain the lemon from the honey making sure all lemon seeds are removed.

6. L et cool, then bottle in a jar with a lid and store in the refrigerator. This syrup will keep for two months in the refrigerator. To soothe a cough, take 1/2 teaspoon for a 25-pound child and 1 teaspoon for a 50-pound child, about four times a day, or as often as needed. Adults can take 1-tablespoon doses.


for Your Life …

and for Your Good Health by JR Whaley


o the uninitiated, running is perceived to be a tedious and painful form of exercise that is useful only for achieving weight loss. Recent studies, however, show that running confers a wide range of health benefits that extend well beyond simple weight-loss. In fact, the Journal of American College of Cardiology has found that even five to 10 minutes a day of low-intensity running is enough to extend life by several years. Yet, the American Journal of Preventive Medicine revealed that only 5% of American adults do some sort of physical activity on any given day. Simply put, not enough people are taking advantage of the health benefits associated with running, which include:


Running Improves Your Mental State “Runner’s high” is not a myth. According to a study published in the Journal of Experimental Biology, running leads to an increase in the release of endocannabinoids—the brain chemicals that signal pleasure and happiness. This explains why runners experience “runner’s high”—the euphoric feeling that occurs shortly after completing a run. In addition, in a study published in Medicine & Science in Sports & Exercise, researchers found that even a single bout of exercise—30 minutes of walking on a treadmill—could instantly lift the mood of someone suffering from a major depressive order. Further, in a 2013 study published in the same journal, researchers concluded that physical activity, such as running, was an effective alternative to treating depression. The mental benefits do not end there. A new study conducted by researchers at the Center for Brain Health at the University of Texas at Dallas found that engaging in a physical exercise regimen, like running, helps healthy aging adults improve their memory, brain health and cognition.

Running Strengthens Your Joints There is a persistent misconception that running will cause damage to your knees. This is simply untrue. In an interview with National Public Radio, Boston University researcher David Felson stated, “We know from many long-term studies that running doesn’t appear to cause much damage to the knees. When we look at people with knee arthritis, we don’t find much of a previous history of running, and when we look at runners and follow them over time, we don’t find that their risk of developing osteoarthritis is any more than expected.” Moreover, some scientists believe that running may even increase bone mass, thus help stem age-related bone loss. Skeletal Radiology, a well-respected medical journal, concluded that continuous exercise is protective, rather than destructive, to bones and joints.

Running Reduces Your Risk of Cancer Colorectal cancer is one of the deadliest forms of cancer. The American Cancer Society has found that 4.7% of men and 4.4% of women are at a lifetime risk of developing colorectal cancer. Yet, according to the Pharmaceutical Research—an official journal of the American Association of Pharmaceutical Scientists—80% of the

causes to colorectal cancer can be prevented via lifestyle changes. Vigorous exercise, such as running, was found to be particular effective in slashing the risks of colorectal cancer. A vast review of 170 epidemiological studies in the Journal of Nutrition showed that regular exercise is associated with a lower risk of colorectal cancer. Further, in 2006, Anne McTiernan, MD, PhD, of Seattle’s Fred Hutchinson Cancer Research Center, conducted an extensive study of 102 test subjects who had a colonoscopy within the past three years. Researchers assigned half of the participants to an hour of vigorous aerobic exercises on a treadmill for six days a week for a year, while not assigning any exercise regimen to the other half. After a year, every participant underwent flexible sigmoidoscopy testing. The researchers found substantially less evidence of cell proliferation in those colon areas for participants who had followed the researchers’ exercise prescription, compared with the study’s other participants who were not assigned a regimen.

Running Lowers Your Cholesterol Level According to the Centers for Disease Control and Prevention (CDC), 73.5 million adults (31.7%) in the United States have high low-density lipoprotein (LDL), or “bad” cholesterol. Further, the CDC warns that people with high total cholesterol have approximately twice the risk for heart disease as people with ideal levels, as excess cholesterol accumulates on the inner lining of blood vessels, leading to arthrosclerosis and heart attacks. High cholesterol comes from a variety of sources, including your diet, your age and gender, your family history, and your smoking habits. Despite numerous sources of high cholesterol, medical experts agree that the best way to lower cholesterol levels is by exercising. A 2007 Danish study of 835 men found that regular physical activity was consistently associated with higher levels of good cholesterol, called high-intensity lipoprotein (HDL). Moreover, according to a study in the Journal of Lipid Research, phasic activities were found to reduce total cholesterol levels in test subjects, but static activities did not.

When You Start, Be Smart “Lifelong runners postpone age-related disability by nearly two decades,” says Kasey Hill, M.D., of Baton Rouge, La., board-certified physical medicine and rehabilitation physician who specializes in diagnosing and treating a wide variety of musculoskeletal and sports injuries, with a focus on biomechanics and individualized rehabilitation programs, particularly for runners. “That means the runner is still out running while his friends are needing assistance to get around.” But with any exercise program, it is important to be smart. “Although it is a relatively cheap, easy, and accessible form of exercise, it certainly comes with the possibility of injuries,” he says. “Most of these injuries can be prevented by smart training and improving biomechanics.” So get started on a more healthy you by taking that first step as a runner. @LIVINGSAFER / LIVINGSAFER.COM / 19

Vitamin B12 and Depression: Is There a Link? by Bret Hanna B vitamins (B1, B2, B3, B5, B6, B9 and B12) are water soluble vitamins that play critical roles in human cell metabolism. They either serve as a coenzyme for critical cell metabolic processes, or as a precursor needed to generate such processes. They also play a role in producing chemicals in the human brain that affect mood and other functions. As such, deficiencies in any of the B vitamins can lead to mood disorders, such as depression. Vitamin B12, or Cobalamin, in particular, has been linked to depression. B12 is a coenzyme that is involved in the metabolism of every single cell in the human body. It is critical to amino acid metabolism, fatty acid metabolism, and the regulation and synthesis of DNA. It is also essential for the cellular metabolism of lipids, carbohydrates and proteins, as well as the production of proteins, nerve sheaths and bone marrow blood cells. Finally, it serves as a coenzyme for certain intermediary metabolic processes. Vitamin B12 deficiencies can result in depression, peripheral neuropathy, cognitive deficits, memory loss, mania, psychosis, elevated homocysteine levels (linked to increased risk of stroke and heart attack), macrocytic anemia (blood with insufficient concentrations of hemoglobin) and in extreme cases, paralysis. Low levels of B12 can result from poor diet or digestive/vitamin absorption issues that those who suffer from celiac disease or Crohn’s disease experience, and those who have absorption issues resulting from gastric bypass surgery. Certain medications, such as Metformin (taken for pre-diabetic and diabetic conditions), can


also inhibit vitamin absorption. A simple blood test can answer the question of whether someone is suffering from a B12 deficiency. Although the specific role of B12 deficiencies in the development of depression is not fully understood, the correlation is strong enough to suggest that they should be ruled out as a potential cause or contribute to symptoms of depression. Moreover, the human body can’t make B12, but an average adult needs 2.4 micrograms per day. If a B12 deficiency is detected, one obvious way to address is to focus on diet. Animal-based foods, such as poultry, fish, eggs, lean meats, and low or fat-free milk, are rich with B12. Breakfast cereals fortified with B12 can also be a good source of the vitamin. Plant-based foods, however, will not help. Plants, like humans, can’t produce B12 on their own. Daily dietary supplements can also be an option for boosting B12 levels, but consult with a healthcare provider before going that route. Vitamin supplements, including B12, can interact with some medications so there may be unintended consequences. Daily dietary supplements can also cause some transient side effects, such as insomnia, restlessness and nausea, so if they are a good option, dosages may need to be sorted out. Finally, it is important to remember that although B12 deficiency may play a role in any one person’s development of depression, efforts to correct the deficiency should be used in conjunction with, rather than as a substitute for, proven depression treatments like psychological counseling and antidepressant therapies.

The Case for Being an

Early Morning Riser by Cade Parian




re you kidding me?” “You are an idiot.” These are the common responses when I get on my high-horse about waking up early. Waking up early saved my life. Many careers are filled with non-stop pressure. Add to your career the pulls and pressures of family life, social drama, etc., it almost seems that life can be unbearable. With these same feelings overtaking my body and mind, I got the swift punch in the gut that I needed. Reading is not something I particularly enjoy. However, I spend a lot of time on airplanes. I wander into an airport bookstore every once in awhile to find a new coloring book. Instead, in September 2015, I picked up a (non-coloring) book that changed my life forever. I picked up a copy of Hal Elrod’s newest book, “The Miracle Morning – The Not-So-Obvious Secret Guaranteed to Transform Your Life Before 8am.” Elrod is one of those guys that got rich early in life. He also went broke very soon thereafter. To make matters worse, he was hit head on by a drunk driver causing him to die for over six minutes, suffer permanent brain damage, and to be told he would never walk again. Despite all of those obstacles, he overcame and is now an ultra-marathon runner, father and bestselling author. I assume that most people are like me, 8:00 am is a respectable wakeup time. Even 7:00 am is difficult, but doable. But at 6:00 am, somebody is going to get hurt and 5:00 am is when nothing is awake other than ghosts and mass murderers. Elrod’s book outlines a plan to transform your life by doing six essential tasks prior to 8:00 a. After reading the book (TWICE!!), I implemented the steps. At first, I felt goofy. Now, I feel better than I ever have in my life. The following quote from iconic journalist George Lorimer sums up my feelings: “You’ve got to wake up every morning with determination if you’re going to go to bed with satisfaction.”

The Life SAVERS Here are Elrod’s practices from my perspective. Each of the letters in SAVERS stands for an activity that I engage in each morning. Let’s go through them.

“S” is for Silence – I was the most skeptical of this practice. The book encourages you to wake up early each morning to sit in silence. You have the same question that I have, I am sure. Won’t I just fall back asleep? In my experience, the answer is no. Elrod encourages you to sit in silence praying, meditating, listening to your breath or reflecting. For the first couple of weeks, I sat there and thought, “What in the world am I doing?” Then I started appreciating the silence. You cannot appreciate silence until you discover that almost all of your days and nights are filled with noise. Noise can come from kids, spouses, barking dogs, or invented drama in your head. Having the ability to empty your mind first thing in the morning makes for a more energizing day.

“A” is for Affirmation – We all know that optimism is good. However, it is powerful stuff when you tell yourself each day that it will be a good day. A lot of that chatter in our heads is generated by negativity. Spending time each morning filling your head with positive affirmations fights off the effects of “blue-ish” thinking. When you have self-doubt, thinking that doubt away with selfaffirmation gives you the power to overcome.

“V” is for Visualization – I read one time that Tiger Woods visualizes every shot he makes prior to taking a swing at the golf ball. Elrod notes that Will Smith visualized his future success before he ever left the projects of Philadelphia. I guess that I have visualized my future before; however, I always called it “living in the clouds.” After reading the book, I spend some time every morning visualizing my day. Notice I did not say the far-off future. I visualize just that day. It is amazing the feeling you have when you visually plan your day. It makes life so much easier.

“E” is for Exercise – I know. You were expecting this one. I have long fought building exercise into my daily routine. I used the “I am too busy/tired” excuse for years. Now exercise is part of my daily routine. I started real simple. I just went outside and walked around my neighborhood for 15 minutes each morning. It was amazing watching the neighborhood come alive! The simple increase in heart rate and deep inhalations of oxygen cleared my mind (and frankly, my soul).

“R” is for Reading – I have already admitted that I am not a fan of reading. But now books and articles are much handier. They exist on the Internet, e-readers, iPads, phones, and via audio. Did you catch that last one? Books can be downloaded to be listened to via audio. This is perfect for me. Some days, I listen to a positive self-help book while exercising. Other days, after I have exercised hard, I listen to a book while I rest afterward. Nevertheless, I read. It is important to expand your mind every day. Otherwise, it turns to mush (I think).

“S” is for Scribing – Like silence, this one was a head scratcher for me. At first, I wondered what to write? It seemed that each morning the first thing that I wrote was “I am tired.” There is no limit as to what topic you should write on. Write about your goals, dreams, plans, family, commitments, lessons learned, etc. The goal is not to write perfectly. The goal is to get it out of your brain. Dump it on to a piece of paper. It is amazing how much clarity you get from simply writing. In fact, I am gaining clarity by writing this article. There you have it, folks. I encourage all of you to implement them in some form. I cannot begin to describe the effects of these activities on my life. We owe it to everyone around us to live out our best lives. We enjoy hearing from others on how they live their best lives. Send your story to sandre@livingsafer.com.


Hacking a Hangover Is There Really a Cure? by Jeff Gutowski inding the cure to the hangover is like searching for the Holy Grail. Everyone with a fun aunt and uncle has their own preference and two family recipes for dealing with the pain, nausea and malaise that comes after a hard night out. (Unfortunately, hangover cures don’t help the accompanying embarrassment.) There are literally hundreds of so-called cures available one click away. Why so many, you ask? Probably because although the discovery of the first hangover followed closely the discovery of fermentation, very little is understood about the science behind a hangover. Besides, the only true way to compare “cures” is by risking liver damage. As always, an ounce of prevention is worth a pound of cure and while drinking alcohol in moderation may not make you as fun as you used to be, it will certainly help you avoid the morning after. Otherwise, drinking water is always a good way to avoid the dehydration that accompanies alcohol indulgence. Some prefer to go double fisted at parties by drinking a glass of water for


every glass of wine. This not only makes introductions and buffet tables a real challenge, but you may end up spending most of your time either in the bathroom or standing in line at the bathroom. Drinking a tall glass of water with a couple of aspirin before going to bed has long been a rule of prevention. (Don’t substitute acetaminophen for aspirin because of toxic effects on the liver.) In addition to the amount of alcohol consumed, the quality of the alcohol consumed also has an effect on preventing (or encouraging) hangovers. Vodka and gin are better choices than brandy, whiskey or red wine. However, if you wake up bleary eyed, cotton-mouthed, foggy, nauseous and with a really bad headache (because you forgot rule number one), then here are a couple of suggestions and some others that I wouldn’t even try on your inlaws. “Cures” generally fall into two categories: “hair of the dog” (or why stop drinking now?) and fat and protein consumption. Don’t be afraid to combine the two for maximum effect. @LIVINGSAFER / LIVINGSAFER.COM / 25



Bloody Mary - The Bloody Mary could be considered a “hair of the dog” hangover cure except for the fact that they’re just so darn good, all the time. This drink is not just for breakfast any longer. There are plenty of great Bloody Mary recipes and if you want the easy way out all you need is a mix and some vodka. For an unAmerican twist, use raw eggs instead of vodka. No, not sure why you would do that, either.

Bacon Sandwich - Nothing says comfort


food like bacon. The bacon sandwich is preferred throughout the UK as a cure for the hangover and who are we to argue with their expertise. Besides, can anyone really protest something as divine as a sandwich dedicated to bacon?

Pickled Herring – Nothing says hangover like Oktoberfest and the Germans must know something about hangovers, too. Somewhat related, some countries swear by drinking pickle juice, straight. If the thought of drinking straight vinegar doesn’t make you ill, that is.



Beer – Drinking beer is another “hair of the dog” cure, which can also be used to slingshot your way to another fun evening. (See rule number 1).

The Prairie Oyster – This “hair of the dog” cure combines alcohol and raw egg, which is about the only way to get me to eat raw egg. You can use vodka, but brandy works too. Just separate and drop an egg yolk in, with Worcestershire sauce and hot sauce. Bottoms up.

HERE ARE A COUPLE OF FUN “CURES” FROM THE REST OF THE GLOBE: Buried up to the neck in wet river sand – This is the cure of Celtic legend. All you need is a river and a really deep hole.

Tripe Soup – This cure is preferred in Eastern Europe and requires you find a cow or pig stomach and be willing to make a soup with it. If someone actually tries this, please let me know.



Sleep – Time is really the only “cure,” for a hangover. It generally takes between eight and 24 hours, depending on the size of your bender.

Last place. Dried Bull Penis. The Sicilians gave us Cosa Nostra… and dried bull penis for hangovers. First, find a bull in a field. Sneak up on the bull. Using your knife…With this “cure,” why would you even start drinking in the first place? While researching this article, it became all too clear that hangover awareness and funding has woefully lagged that of other less pervasive diseases. As a cause celeb, hangover awareness has been well, hungover. We at least need a ribbon to get the word out. Can’t we just cure the common hangover?


the Work/Life Balance by Jon Lewis


ith competition and technology today, work and personal lives are being blurred. Smartphones may provide a method for efficiently handling work, but they also keep people connected to their jobs 24/7. Further, with the increase in population and difficult economy, good jobs are competitive and you have to stay on top of your game. These factors cause extreme stress and require good self management skills in order to strike a balance between work and home. So, what can you do to manage these stressors? Here are some suggestions to help you balance the two.






T  ake a Vacation – This can be one of the most important


Spend Quality Time with Family and Friends – This

Be Selfish – In today’s world, you work for your boss and your customers. You do things for your family and friends. You participate in community activities and charities. But, do you take time for yourself? Do something for you at least once a week. That could be learning a musical instrument, getting a massage, playing golf, going on a hike, or whatever. Just take time for you.

Exercise – A key to reducing stress and clearing your mind is exercise. It can also be healthy as long as you follow a doctor’s recommendations. Exercise does not have to be overly strenuous. It can be a simple walk in the morning. Or, you can also participate in more competitive activities, such as road races, triathlons, cycling, swimming, etc. If you join an athletic club or running club, you can also meet people with similar interests, and that can lead to more and better clients.

Organize – Plan your days, weeks and months. Have goals. If you set goals and organize your days, you feel less stress because you have a plan to follow. Everyone likes structure no matter what their age, and if you learn to structure yourself, you will be better prepared and less stressed, and it will show. Your boss or clients will see your skills, and that can lead to promotions and more referrals.


Schedule Your Personal Life – Some people follow a


Just Say No – This can be one of the hardest things


Be Spiritual – How? Meditate. Go to church or temple.

schedule religiously. If that’s you, put personal and family events on your calendar. Make your personal life part of your schedule, and you won’t miss time with family and friends.

to learn. If you get caught up thinking you need to do everything asked of you, you will feel overwhelmed and get in a quicksand mode. Sometimes, you have to turn down that request be it from your boss, a charitable organization, church or social club. It’s OK. Maybe this isn’t the year, and next year you can agree and even do a better job because you waited until you truly had the time.

Do yoga. This is simply a way of clearing your mind and relaxing yourself to recharge.





things to do. You cannot work nonstop without running yourself down. Vacations allow you to unwind, spend time with family and friends and recharge your batteries. When you return to work from vacation, your body is ready to get back at it.

can be nightly dinner or playing a board game (they do still exist and are fun). Turn your phone off and give your attention to your spouse and kids. Or, if you don’t have family, go out to dinner with friends or have a get together at the house. This takes your mind off of work and helps you develop quality relationships.  rite Down Your Values and Goals – When you have W these written down, you can prioritize what is important to you and spend your time that way.

G  et Some Sleep – Sleep is another method of recharging yourself. You have to get an appropriate amount of sleep so that you have energy each day, and you can tackle the difficult problems with less anxiety. Working overtime with less sleep can actually lower your productivity. Sometimes, less is more.

P  eriodically, Take an Inventory of Where You Are – Every six months or year, look back and see how you are doing. Write it down and plan the next six months or year so you can see how you are progressing and what areas need improving.

Many of these suggestions are obvious, but people don’t sit down to do them. It doesn’t have to be a New Year’s Resolution. Start now. You will be glad you did.


We’re on the Web and in Your Hands. Welcome to the all-new Living Safer, the same magazine you’ve come to know and love...just with a more inviting look and feel. And while the face may have changed, our pledge to you remains the same: to offer the best in safety information— from new trends and wellness to lifestyle, home and more.

Join the Conversation. Share and comment on Living Safer stories by joining us on Facebook and Twitter and by visiting LivingSafer.com fb.com/LivingSafer / @livingsafer

Smart Use of Dating Apps How to Avoid Pitfalls and Catfishing by Matt Devoti

ccording to Urban Dictionary, a “catfish” is a person who assumes a false online identity through social media for the purpose of pursuing deceptive online romances. It’s a new term in our vernacular brought about by the marriage of traditional dating services and cyberspace. Thanks to mobile technology, the original online dating website, Match.com, has given birth to a myriad of mobile dating apps that seem to connect everyone with just a simple swipe of the finger. Now through a mobile device, a person looking for romance, friendship, a hook-up or perhaps something more nefarious can peruse pictures, read a profile, begin a chat, swipe to connect, push a button to ‘wink’, and even find a person’s location. Many people love having the entire world as their dating playground because they view it as a convenient way to meet people that trumps the bar scene. Millions of people have profiles on dating sites/apps and research shows that today, 1 in 5 marriages are a result of online dating. So, are these sites and apps really safe to use? The long answer is, if you are going to use a mobile dating app—proceed with an abundance of caution and common sense.


Sensitive information provided is permanent Most dating sites/apps allow a person to do three things: search for and view prospect profiles, chat and setup face-to-face meetings, and matching services based on computer-generated algorithms. In order for the sites/apps to deliver these services, a user must create a profile that contains personal and sensitive information. Some dating profile questionnaires are short, but others are very detailed and delve into very specific information, such as age, sex, religion, education, profession, geographic location, drug use, drinking behaviors and hobbies. Once that information is shared, it is kept by the dating site/app indefinitely. 30 / LIVING SAFER / VOL 8 ED 1

Even if the profile is deleted down the road, all of the pertinent information, including the photos are still out there in cyberspace. This is largely because the dating sites/apps use third-party content delivery networks to store content and photos for fast up-load times. Again, deleting the profile from the dating site/app doesn’t mean it’s completely deleted from the Internet.

Data provided will be exploited Once the profile is out there, other companies swoop in like vultures to feast on the buffet of personal information online dating sites provide. These profiles are an online marketer and data mining company’s dream come true. Obtaining a person’s email address and sending spam is just the tip of the iceberg.

Rip off scams This is where the term “catfish” or “catfishing” comes into play. The majority of these savvy scam artists are from overseas and have exploited dating sites/apps for their latest schemes. These “catfish” create a fake profile and pose as potential romantic partners. They will spend weeks or months earning the trust of their victim and ‘falling in love’ through chats, texts and emails. Once they have the victim ‘hooked’, they will create a fake emergency (medical or travel related) whereby they need money wired as soon as possible. Of course, they promise to pay back the victim when they see them in person. Once the money is sent, the “catfish” simply disappears into cyberspace.

Opening door to predators, felons and stalkers While the majority of people are using these sites safely, there are still safety concerns. For this reason, several services have popped up that allow people to run background checks on potential suitors. Mymatchcheck.com, a site designed by law enforcement officials, is one such site.

Data security Most dating sites/apps do not utilize the https web encryption protocol that ensures data gets encrypted when it is being sent and received over the Internet. Because of this, a hacker could easily eavesdrop on a wireless connection and pick up a person’s username and password and hijack their profile.

Defamation and damaged reputations Any information shared through a profile, including photos can come back to haunt a person. This is a real possibility if a profile is hacked and inappropriate photos or comments are put out there in an effort to sabotage someone. Be very mindful of how much information and what type of information is provided in a profile. Additionally, be very selective of the photos posted. Remember, the Internet has a permanent memory. According to the Privacy Rights Clearinghouse, the following precautions should be taken while looking for love online:

Read the dating site’s terms of service and privacy policy.

»» Does it reveal your photo only to members or also for online advertising? »» Be skeptical about promises of anonymization. Researchers have found it is entirely possible to re-identify records that have been anonymized.

Share photographs with caution. Digital photos have attached metadata such as where and when the image was captured that can be used maliciously. You can scan a photo before sending it and remove the metadata from a JPEG image.

Consider getting a free email account specifically for online dating purposes (from Gmail, Yahoo!, Microsoft, etc.). Better yet, if your dating service offers a blind email service, you should take advantage of this option.

Respect your instincts. Trust your doubts about prospective

»» It should delete data after you close the account.

dates who don’t resemble their pictures or any nagging suspicions that someone is being dishonest. Don’t provide your full name, address and phone number until you have enough information about your prospective date to feel safe.

»» It should be upfront about sharing your personal information with other members.

If a company misuses your data or if you don’t like a privacy

»» It should be upfront about who else gets to see your data.

policy, contact the site immediately to clarify its practices and to register dissatisfaction. Post concerns to social media and file a complaint with the FTC.

Here is what to look for: »» The site should provide online security (https).

»» It should indicate whether the dating site shares your email address with third parties. »» Does it give you a chance to opt out? »» Does it provide the name of a real human being to contact if you have questions? »» Can you be chosen as the “profile of the day?”

Some experts in the industry foresee a day when dating site questionnaires will be unnecessary because all relevant information will be available from Facebook and other social networking sites. Keep in mind that everything you say about yourself online stays online, for better or worse. @LIVINGSAFER / LIVINGSAFER.COM / 31


e h t f o s C B A The s s e c o r P l a FDA Approv by Stephanie Andre

It’s so easy to say, “Sure, I can take this medication. It must be safe. The FDA approved it.” But is that the reality? Addiction numbers continue to rise, and pill mills run through prescription pads like kids with candy. Given this, it’s easy to become cynical and concerned that perhaps part of the blame falls to the governing agency—the one that put these medications in our palms at the start: The Food and Drug Administration. So we decided to check the process ourselves. Admittedly, there’s not much in the way of studies to disprove that the FDA is doing its job. Yet, one still feels as though the agency could slow down the process, instead of giving way to notions that drug companies can buy their way toward faster approvals, thereby shortening up clinical trials and never fulling understanding the long-term effects of such medications. To that end, in this issue’s cover story, we break down the FDA approval process and see where there may be some options for growth.

The Drug Approval Process Drug companies seeking FDA approval to sell a new prescription drug in the United States must test it in various ways. First are laboratory and animal tests. Next are tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease. After testing the drug, the company then sends FDA an application called a New Drug Application (NDA). Some drugs are made out of biologic materials. Instead of an NDA, new biologic drugs are approved using a Biologics License Application (BLA). Whether an NDA or a BLA, the application includes

Is it Really Safe?

• The drug's test results • M  anufacturing information to demonstrate the company can properly manufacture the drug • T  he company's proposed label for the drug. The label provides necessary information about the drug, including uses for which it has been shown to be effective, possible risks, and how to use it. If a review by FDA physicians and scientists shows the drug's benefits outweigh its known risks and the drug can be manufactured in a way that ensures a quality product, the drug is approved and can be marketed in the United States.


The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. However, an important use of a drug may also be discovered by accident. For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. Twenty years later, researchers discovered the drug could treat AIDS, and FDA approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987. Most drugs that undergo preclinical (animal) testing never even make it to human

testing and review. However, the drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug—from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.

How Does an Application Get Reviewed? Though FDA reviewers are involved with a drug's development throughout the investigational stage, the official review time is the length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency's decision. Once a new drug application is filed, an FDA review team— medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts—evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use. No drug is absolutely safe; all drugs have side effects. “Safe” in this sense means that the benefits of the drug appear to outweigh the known risks. The review team analyzes study results and looks for possible issues with the application, such as weaknesses of the study design or analyses. Reviewers determine whether they agree with the sponsor's results and conclusions, or whether they need any additional information to make a decision. Each reviewer prepares a written evaluation containing conclusions and recommendations about the application. These evaluations are then considered by team leaders, division directors, and office directors, depending on the type of application. Reviewers receive training that fosters consistency in drug reviews, and good review practices remain a high priority for the agency. Sometimes, the FDA calls on advisory committees, who provide FDA with independent opinions and recommendations from outside experts on applications to market new drugs, and on FDA policies. Whether an advisory committee is needed depends on many things. ”Some considerations would be if it's a drug that has significant questions, if it's the first in its class, or the first for a given indication,” says Mark Goldberger, M.D., a former director of one of Center for Drug Evaluation's drug review offices. ”Generally, the FDA takes the advice of advisory committees, but not always,” he says. ”Their role is just that—to advise.”

Accelerated Approval Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available. Instead, less traditional measures called surrogate endpoints are used to evaluate effectiveness. These are laboratory findings or signs that may not be a direct measurement of how a patient feels, functions, or survives, but are considered likely to predict benefit. For example, a surrogate endpoint could be the lowering of HIV blood levels for short periods of time with anti-retroviral drugs. Gleevec (imatinib mesylate), an oral treatment for patients with a life-threatening form of cancer called chronic myeloid leukemia (CML), received accelerated approval. The drug was also approved under the FDA's orphan drug program, which gives financial incentives to sponsors for manufacturing drugs that treat rare diseases. Gleevec blocks enzymes that play a role in cancer


growth. The approval was based on results of three large Phase 2 studies, which showed the drug could substantially reduce the level of cancerous cells in the bone marrow and blood. Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval. Because premarket review can't catch all potential problems with a drug, the FDA continues to track approved drugs for adverse events through a postmarketing surveillance program.

No Smooth Sailing If the FDA decides that the benefits of a drug outweigh the known risks, the drug will receive approval and can be marketed in the United States. But if there are problems with an NDA or if more information is necessary to make that determination, the FDA may issue a complete response letter. Common problems include unexpected safety issues that crop up or failure to demonstrate a drug's effectiveness. A sponsor may need to conduct additional studies—perhaps studies of more people, different types of people, or for a longer period of time. Manufacturing issues are also among the reasons that approval may be delayed or denied. Drugs must be manufactured in accordance with standards called good manufacturing practices, and the FDA inspects manufacturing facilities before a drug can be approved. If a facility isn't ready for inspection, approval can be delayed. Any manufacturing deficiencies found need to be corrected before approval. “Sometimes a company may make a certain amount of a drug for clinical trials. Then when they go to scale up, they may lose a supplier or end up with quality control issues that result in a product of different chemistry,“ says Kweder. “Sponsors have to show us that the product that's going to be marketed is the same product that they tested.“ John Jenkins, M.D., director of CDER's Office of New Drugs, says, “It's often a combination of problems that prevent approval.“ Close communication with the FDA early on in a drug's development reduces the chance that an application will have to go through more than one cycle of review, he says. “But it's no guarantee.“


Is the Clinical Data Reliable? The FDA relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials, and to verify the quality and integrity of data submitted, the FDA's Division of Scientific Investigations (DSI) conducts inspections of clinical investigators' study sites. DSI also reviews the records of institutional review boards to be sure they are fulfilling their role in patient protection. “FDA investigators compare information that clinical investigators provided to sponsors on case report forms with information in source documents such as medical records and lab results,“ says Carolyn Hommel, a consumer safety officer in DSI. DSI seeks to determine such things as whether the study was conducted according to the investigational plan, whether all adverse events were recorded, and whether the subjects met the inclusion/exclusion criteria outlined in the study protocol. At the conclusion of each inspection, FDA investigators prepare a report summarizing any deficiencies. In cases where they observe numerous or serious deviations, such as falsification of data, DSI classifies the inspection as “official action indicated“ and sends a warning letter or Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) to the clinical investigator, specifying the deviations that were found. The NIDPOE begins an administrative process to determine whether the clinical investigator should remain eligible to receive investigational products and conduct clinical studies. CDER conducts about 300-400 clinical investigator inspections annually. About 3% are classified in this “official action indicated“ category. The FDA has established an independent Drug Safety Oversight Board (DSOB) to oversee the management of drug safety issues. The Board meets monthly and has representatives from three FDA Centers and five other federal government agencies. The board's responsibilities include conducting timely and comprehensive evaluations of emerging drug safety issues, and ensuring that experts—both inside and outside of the FDA—give their perspectives to the agency. The first meeting of the DSOB was held in June 2005.

Drug Review Steps for the Everyday Joe


Preclinical (animal) testing.


An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.


Phase 1 studies (typically involve 20 to 80 people).


Phase 2 studies (typically involve a few dozen to about 300 people).


Phase 3 studies (typically involve several hundred to about 3,000 people).


The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.


Submission of an NDA is the formal step to the FDA to consider a drug for marketing approval.


After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.


If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.


The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).


The FDA inspects the facilities where the drug will be manufactured as part of the approval process.


FDA reviewers will approve the application or issue a complete response letter.


What Do You Want to Know? Often, many people have the same questions. Following are some Q&A to help clear up any confusion.

Q: Why are drugs evaluated by the FDA? A:

Drugs intended for human use are evaluated by FDA’s

Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research.

Q: What are clinical trials and how do they relate to drug approval? A:

Clinical trials are studies that use human subjects (people) to see whether a drug is effective and what side effects it may cause. The trials are for gathering information about a drug that has not yet been proven to treat patients with a specific condition. A drug being studied in a clinical trial is called an investigational drug. Clinical trials of drugs provide information about: • Whether the drug has the effect it is supposed to have. • How much of the drug to give to a patient and how often.

Q: Does the FDA test drugs? A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists and other scientists.

Q: How long does the drug approval process take? A: The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system—Standard Review and Priority Review. Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10-month goal for a standard review. Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months. 36 / LIVING SAFER / VOL 8 ED 1

• What side effects are associated with the drug and how they can best be managed. • How a drug is broken down in the body, and how long it stays in the body. • Which foods, drinks, or other drugs can be used at the same time or should be avoided. • Clinical trial results allow the FDA to make decisions about whether or not a drug should be approved for marketing.

Q: What are the different types of drug applications that can be submitted to the FDA? A: • Investigational New Drug (IND) — Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. • New Drug Application (NDA) — When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet the FDA's requirements for marketing approval, the sponsor submits a new drug application (NDA) to the agency. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics and statistics. If the NDA is approved, the product may be marketed in the United States.

• Abbreviated New Drug Application (ANDA) — An Abbreviated New Drug Application contains data that provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic drug applicant must scientifically demonstrate that its product is bioequivalent (performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product. • Biologic License Application (BLA) — Biological products are approved for marketing under the provisions of the Public Health Service Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Q: Do over-the-counter (OTC) medications go through the same approval process as prescription drugs? A:

No. Because there are more than 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids. For each class, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of “recipe book“ covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process. A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling. @LIVINGSAFER / LIVINGSAFER.COM / 37

by Ryan R. Bradley


If you turn on the television or read magazines, you have seen advertisements for medications and medical devices. While these advertisements primarily focus on drugs, in recent years, makers of medical devices have begun to aggressively market their products not only to doctors and surgeons, but also to the general public. Just as medications and drugs marketed to American patients must gain approval from the FDA, so do medical devices. The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis or treatment of a disease or medical condition.” Therefore, medical devices can range from a Q-tip to a hip implant to a pacemaker. If you are a company with a new medical device, there are two primary ways to bring your device to the American market by way of the FDA: One process is called Premarket Notification, often called the 510(k) process. The other is called Premarket Approval and is known by its submission acronym PMA. There is, however, a radical difference between the two approval processes.

The 510(k) Fast Track 510(k) is actually a section of the federal Food, Drug and Cosmetic Act. In that lawyers are not overwhelmingly creative, it was named after the Code Section. The 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. A company attempting to bring a device to market under the 510(k) process must submit a relatively simple filing to the FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. These are not high standards and do not constitute FDA approval of a device.

It is important to understand that simply because a device, such as metal-on-metal hip prostheses, is cleared by the FDA for marketing; it does not mean that they are safe. In fact, the U.S. Supreme Court has said as much, noting the 510(k) approval does not constitute an approval by the FDA as to the quality of a device. Finally, since the FDA wants to encourage technological advancement, the new device does not have to be manufactured from the same materials or perform its intended purpose using the same technology. Rather the “old” device to which the new one is being compared must only be substantially similar.

The Conventional Pre-Market Approval Approach Conversely, Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses. This is a far more rigorous process consisting essentially of four steps: • Administrative and limited scientific review by FDA staff to determine completeness (filing review). • In-depth scientific, regulatory, and Quality System review by appropriate FDA personnel. • Review and recommendation by the appropriate advisory committee (panel review). • Final deliberations, documentation, and notification of the FDA decision. The PMA process takes far more time, effort, and resources on the part of the manufacturer and consequently the 510(k) is used far more often by medical device companies.



Easy Swaps to Make Your Diet Healthier by Robert Roe


our life is busy. If you’re like most, planning out your meals isn’t something that comes naturally. After all, isn’t it just easier to cook with what you know? Well, what you know isn’t always the healthiest option. Here are some simple changes you can make to help cut back on the calories, cholesterol and carbs.



Cut the Carbs: Use walnuts instead of croutons in your salad By substituting raw walnuts for croutons, the amount of carbohydrates you’re consuming for your meal decreases dramatically. Walnuts have half the amount of carbs as the double-baked, extra salty croutons, while still giving you the crunch. Walnuts are also chock-full of omega-3 fatty acids, which are most known for the protective effects on the heart.

Swap Out the Saturated Fats: Use Greek yogurt instead of sour cream Sour cream is a popular topper for salads, soups, tacos, baked potatoes and more. However, sour cream is also high in saturated fat. Saturated fat can raise your low-density lipoprotein (LDL), also known as the “bad” cholesterol levels. Comparing the nutritional breakdown of sour cream and Greek yogurt there is a huge difference between the two. Sour cream has more than double the amount of calories per serving and more than five times the amount of saturated fat. Greek yogurt also is a great source of calcium. If that’s not enough to make the swap, Greek yogurt has the same tang and creamy features as sour cream, so you won’t be missing a thing.

Have Your Dessert and Eat It Too: Replace oil with applesauce in baked goods After a long week who doesn’t love a brownie straight from the oven? Swapping out the oil with applesauce you’re able to treat yourself without feeling like you’ve overindulged. Now, oil isn’t all that bad for it contains monosaturated fats which can help reduce cholesterol levels. However, too much of a good thing can be unhealthy, especially if it’s high in calories. Applesauce has roughly 10 times less calories that oil does and contains no monosaturated fats. Applesauce also has natural sugar in it so your desserts come out just as sweet. The next time you’re whipping up your favorite baking treat, use a one-to-one ratio and swap out the oil with applesauce.

Fit More Fiber In: Eat whole fruit instead of drinking fruit juice Most fruit juices in stores are made with very small percentages of real fruit juice. Even when you do find one that advertises it is made with 100% real fruit juice, it is still missing a very important benefit that whole fruit offers— Fiber. If you pick up a glass of apple juice it looks nice and clear. That is because the fiber has been removed. If instead of drinking the apple juice, you ate a couple of apples it would double your daily fiber intake, while also cutting your sugar intake. Fiber is very important in your daily diet. It is what makes you feel full and helps keep your digestive system regular.


by Mark Bello eeling grumpy or down in the dumps? It could be your diet. Most people understand the link between what they eat and their physical health, but, rarely consider how their food choices affect their mood. Research suggests that what we eat can determine how we feel. Think about Thanksgiving, the meal that leaves you sluggish and sleepy. What about that Starbucks Caffé Vanilla Frappuccino (69 grams of sugar). But, how we feel can also determine what we eat—for better or worse. People in a good mood are more likely to consume foods low in sugar, salt and fat. On the other hand, people in a negative frame of mind are more likely to choose sugary, fatty or salty— comfort—foods. Think about it, are you likely to choose a salad when you’re really stressed? Let’s look at how it works. The nutrient building blocks for

considered comfort foods. But, these foods create a spike of energy followed by a crashing low. Such constant fluctuations in your blood sugar can cause mood swings and fatigue. The most effective way to stabilize mood is to keep your blood sugar stable throughout the day. This can be done by eating a balanced diet of protein, carbohydrates, fruits and vegetables, and limiting sugar, fat and alcohol. The secret lies in knowing which foods have the most positive effect on your mood. Just eating the right foods is not enough. Research shows that eating at regular intervals (every four to five hours) helps to ensure that your body has a continuous source of fuel to keep your blood sugar level and your mood stable. Also, don’t skip meals, especially breakfast. Starting a day off without fuel can lead to a bad mood. The bottom line is, not only what we eat, but when we eat can

your brain chemicals—called neurotransmitters—affect how you feel, your thoughts and your behavior. One important neurotransmitter is serotonin, the “feel-good” hormone. When serotonin is low, you are more likely to feel stressed, angry or depressed. Endorphins is another chemical in your body that helps you cope with stress. Foods that trigger endorphins are chocolate, ice cream and other sweets. That is why they are

highly affect how we feel. Next time you eat, pay attention to how you feel afterward. You may notice that if you ate a healthy, wellbalanced meal that’s rich in fruits, vegetables, whole grains, lean proteins, and healthy fats you feel much better and have more energy than if you reached for a café latte or bowl of ice cream. And, don’t negate the importance of adequate sleep and regular exercise to reducing stress and improve your mood.



Poultry, seafood, eggs. These high protein foods give you energy to build and repair body tissues, helps prevent fatigue, improve your focus and reduces feelings of depression.

Sweet potatoes, beans, apples and pears. These foods are all good sources of insoluble fiber, which, like protein, will slow the absorption of sugar in the blood, causing you to feel happier longer.

Lean beef, cottage cheese, spinach and shellfish. These foods are all rich in vitamin B12.

Whole grain foods, such oatmeal, quinoa, brown rice, whole-grain breads and whole-grain cereals. Packed with complex carbohydrates, these foods can boost the level of serotonin in your brain, elevate your mood and help you relax. The carbohydrates to avoid are those that are highly processed and contain simple carbohydrates, such as sugary foods and drinks.

Fatty fish (tuna, salmon, trout), walnuts, and flaxseed. These foods are excellent sources of omega 3 fatty acids. Research has shown that omega 3 fatty acids alter brain chemicals linked with mood— specifically dopamine and serotonin.

Yogurt, milk, fish with bones. These foods have high amounts of vitamin D. Vitamin D comes predominantly from sunlight absorption, which is why many people in northern climates and during the winter suffer from vitamin D deficiency. This can lead to mood problems which is one reason many experts recommend vitamin D supplements.

Lentils, beans, spinach, broccoli, pumpkin seeds and tofu. Eating these iron-rich foods can keep you from feeling fatigued and irritable, and your red blood cells pumped up with oxygen.

Milk, green teas, and water. While coffee and soda can briefly increase your energy, mental clarity and concentration, too much caffeine can create cravings, depression, insomnia and mood swings. Milk and green teas are a better option, and nothing can replace the benefits of water.


Study: Noise Makes You Full? by Jim Edward esearchers at Brigham Young University and Colorado State University have found that the noise your food makes while you’re eating can have a significant effect on how much food you eat. The “Crunch Effect,” as they call it, suggests you’re likely to eat less if you’re more conscious of the sound your food makes while you’re eating. Therefore, watching loud TV or listening to loud music while eating can mask eating sounds that keep you in check. “For the most part, consumers and researchers have overlooked food sound as an important sensory cue in the eating experience,” said study coauthor Gina Mohr, an assistant

Elder and Mohr carried out three separate experiments on the effect of that “food sound salience” and found even suggesting people think of eating sounds (through an advertisement) can decrease consumption. The most fascinating experiment discovered people eat less when the sound of the food is more intense. In that study, participants wore headphones playing either loud or quiet noise while they ate snacks. Researchers found the louder noise masked the sound of chewing and subjects in that group ate more—4 pretzels compared to 2.75 pretzels for the “quiet” group. “When you mask the sound of consumption, like when you

professor of marketing at CSU. This study appeared in the academic journal Food Quality and Preference. “Sound is typically labeled as the forgotten food sense,” adds Ryan Elder, assistant professor of marketing at BYU’s Marriott School of Management. “But if people are more focused on the sound the food makes, it could reduce consumption.” To be clear, the researchers are not talking about the sizzle of bacon, the crack of crème brulee or popcorn popping. The effect comes from the sound of mastication: chewing, chomping, crunching.

watch TV while eating, you take away one of those senses and it may cause you to eat more than you would normally,” Elder said. “The effects many not seem huge—one less pretzel—but over the course of a week, month, or year, it could really add up.” Elder and Mohr said the main takeaway for people should be the idea of mindfulness. In other words, being more mindful of not just the taste and physical appearance of food, but also of the sound it makes can help in “nudge” consumers to eat less. So next time you eat, pull out your earbuds and tune into the sweet sounds of your food.




When is the Best Time to Have Another Baby? by Edward L. Graham



regnancy is stressful on a woman, both physically and emotionally. So too are the processes of labor, delivery and adapting to the needs and demands of a young infant. A new mom needs time to rest and recover. Her new baby needs the mom’s devoted attention. After the toll of pregnancy, labor, delivery and transition to motherhood, it is a very personal matter whether and when to get pregnant again. Answers range from “As soon as I can!” to “Never!,” and all intermediate possibilities. Regardless of how quickly you want to have another child, consider the following medical issues when making the important decision of when to get pregnant again.

First of all, when can a woman get pregnant again? A woman can get pregnant as soon as two to three weeks after delivery, even without having a period. In fact, the first few months after delivery are one of the most fertile times for a woman. Getting pregnant too soon, however, has important health consequences for the woman and her family. With respect to the mom, pregnancy depletes vitamins and other nutrients from the woman’s body. It takes a full year after delivery for most women to restore their sound nutritional status, which is needed for an optimal next pregnancy.

There may also be complications or after effects with which she must deal from the prior pregnancy, like weight gain, swollen legs and feet, constipation, painful breasts, lethargy and fatigue. These need to resolve before a new pregnancy causes a worsening of such problems. Having delivered by C-section is another reason to delay the subsequent pregnancy, as C-section is major surgery from which the woman needs time to recover. A new pregnancy can also interfere with breast milk production, impacting the wellbeing of the recently born baby who is being breast-fed. The new baby has other maternal needs, such as physical bonding, loving human interaction, care and stimulation. Needs of demanding toddlers are best met before the next pregnancy ensues. 46 / LIVING SAFER / VOL 8 ED 1

The strongest reason for delaying the next pregnancy is the potential negative impact on the newly conceived baby. Getting pregnant too soon increases the risk of preterm birth. Preterm birth introduces greater risks to the baby of organ damage, including but not limited to respiratory problems and brain damage. The greater the prematurity, the greater the risks. Many preterm babies do well, but unnecessary risks of impaired respiratory function, motor function and cognition should be avoided whenever reasonably possible. Based on such considerations, most physicians recommend waiting at least a year between pregnancies. The Office on Women’s Health, part of the U.S. Department of Health and Human Services, agrees. The March of Dimes recommends waiting at least 18 months. Any woman considering getting pregnant sooner than these recommended waiting periods should recognize the risks entailed by that decision. There may be valid reasons to get pregnant again sooner, such as declining fertility, but the countervailing risks should be carefully considered and balanced against other objectives. An important part of deciding when to get pregnant again is the issue of birth control. Many consider breast feeding a form of birth control, but it is hardly foolproof. If the baby is less than 6 months old, receives all nutrition from the mom’s breast milk, and the mom’s menstruation has not returned to normal, breast feeding is around 98% effective as a form of birth control. It is considerably less effective when not all three criteria are met. Yet all women should recognize that any time there is sexual intercourse, there is a chance to get pregnant. To avoid unwanted pregnancy the year after delivery, there are special birth control precautions of which women should be aware. Birth control options that contain both estrogen and progestin have a risk of causing blood clots that can potentially create devastating harm. The pill, patch and vaginal ring all fit into this risk category. If the woman has no other risks of blood clots, and delivered vaginally, she should wait at least three weeks after delivery to use these forms of birth control. For women who delivered by C-section, or who have other risk factors, the wait should be at least six weeks. Other risk factors for blood clots include obesity, smoking, preeclampsia and a history of blood clots. By waiting at least a year before you get pregnant again, you maximize your health, safety and well-being, as well as that of your new baby, and the next one to arrive. Unless there is a very good reason to get pregnant again sooner, use safe birth control methods and wait at least a year to get pregnant.

How Parents Can Help Students

Overcome Testing Anxiety by Erika Oppenheimer It’s easy to understand why students find testing stressful, particularly when they have had bad experiences in the past. But tests also provide opportunities. Most people are aware of testing as an opportunity to demonstrate knowledge. The testing experience also challenges students to develop mindsets and habits that will pay off down the line when they face high-demand situations in other areas of their lives. It is hugely important to first listen to and acknowledge a student’s concerns, but parents can also empower their children by suggesting mindsets and techniques to create a better testing experience moving forward. As a test prep coach, I have seen these six strategies help students who came to me with a variety of fears and frustrations. As you encourage your child to adopt these healthy habits, he or she will have a better experience with testing and likely earn a better score.

rather than as indicative of how they are performing, the feelings may subside. Remind your child that it is OK to feel nervous, and that the preparation they’ve done in advance of the test will support them when the nerves arise.

Take a Breath In the test room or out, when students become aware of anxiety, their first step should be to take a breath. Although it might sound trite or a little too easy, all one needs to do is actually take a full, deep breath to recognize how restorative a breath can be. Guide children to put their hands on their bellies and observe their hands move out as they inhale and move in as they exhale. They can also incorporate a count: breathe in for a count of four and out for a count of four.

Focus on the Next Right Action Stay Process Oriented Emphasize good study, time management and organization skills leading up to the test. Experiment with new learning techniques. As students try new approaches to learning, they will find methods that work effectively for them while keeping the study process fresh and engaging.

Treat the Test Like Practice Each test isn’t only a culmination of the weeks a student has spent preparing, but also practice for his or her next test-taking experience. Becoming a confident, centered test taker may not happen overnight, but it can happen over time, so long as students stay curious and open-minded as to what aspects of preparation and performance are working well and what they might do differently.

Feeling Nervous is OK No one enjoys negative feelings, period. This is particularly true when under pressure to perform well. People often think that feeling nervous or uncertain means that they aren’t doing or won’t do a good job. However, if students can accept these feelings as just feelings—and, for that matter, a normal part of test taking—

Reflection and analysis are helpful only to an extent. While review of previously completed tests can inform future behavior, it can also lead to intense self-criticism. Encourage your child to move forward by asking him or her, “What’s your next right action?” Reinforce that this is true in the test room, too. Reassure students that their best guess is always good enough. Encourage them to mark the questions they feel unsure about for later review and then move on to the next question rather than staying stuck on the difficult question, which will often lead to greater feelings of uncertainty and frustration.

Set a Goal—Other than the Score—for Each Test Encourage your child to articulate a goal for his or her next test that has nothing to do with the score. Having a separate goal reduces the pressure students feel about the score, gives them a greater feeling of control, and facilitates more mindful, centered test taking. Examples of alternative goals include “To take a breath when I feel nervous;” “To keep moving when I feel stuck on a question;” and “To remind myself that I am prepared when I’m unsure of an answer.” @LIVINGSAFER / LIVINGSAFER.COM / 47

Should You

Run a Background Check on Your Nanny or Babysitter? by Maureen May

It is hard to leave your child in the care of another. You want your child to be safe and enjoy their time with a chosen babysitter without the fear of negligent or criminal behavior by your selected caregiver. Employers run background checks on new hires. Landlords run them on potential tenants. These standard practices are givens within their industries. Is it necessary for parents to run a full background check on a short-listed nanny or babysitter? Consider both scenarios.

Without a Background Check Those who forgo a background check may have good reason. When a nanny or babysitter is a close family member, such as a mother or grandmother, it may irk them to know that a background check must be run. When families have a close relationship with each other they know quite a bit about the other person and some parents choose not to run a check. They do take a risk that a family member has a personal or criminal history that they are unaware of or that they may not be able to assist a child in the case of an emergency. As individuals age, they can experience impaired vision that can endanger themselves and a child in their care or may no longer be able to physically lift and carry a small child if necessary. Such individuals may not be able to admit that they are no longer as 48 / LIVING SAFER / VOL 8 ED 1

able-bodied as before and unintentionally not be the best suited to care for a child. In another situation, a parent may choose to ask a teenager of a friend to babysit. Depending on the child, it may be highly doubtful that they have committed a serious crime or be somehow incapacitated during the period with your child. Neither previous knowledge of a person’s individual capabilities or running a background check will be a 100% foolproof. Additional information from a background check offers a few more details and red flags of criminal or undesirable activities that were performed and caught. As parents, we do the best we can for our child and make a judgment call on a situation. A thorough background check does cost money and some may not want or be able to afford the additional expense for a brief period that a child is left with another.

With a Background Check Any new individual who will be left in sole care of children can affect their well-being. This might mean that a nanny gives them an extra snack or two and lets them stay up past their bedtime. It could also mean they suffer from a disorder than can affect the long-term health of a child. There are a wealth of reasons why today’s parents run background checks on nannies and other caregivers for their children.

You read the headlines. “Deranged Nanny Kills Two Kids on Upper East Side.” No one ever envisions that their family will be impacted by tragedy. Parents choose to run background checks to avoid placing their children in the care of potentially dangerous people and damaging influences. These parents know: »» Adults will not always fully disclose their past work histories. References are usually given to provide a positive picture and are selectively chosen by potential employees. If they had a negative experience with another babysitting situation, most will not freely offer up their contact information. »» Adults may not offer information on drunk driving incidents, convictions of child abuse or negligence, past incarceration or mental illness. »» People can give incorrect information about their identity to gain access to a home or the occupants. If you are new to the process of hiring a sitter or nanny, you may not realize the importance of background checks today. As a young child, a neighbor may have sat for you and you were fine. This is the general situation for most. Beyond references and interviews, a background check is becoming the new norm as parents do not want their children to become the next victim of a predator.

Protect Your Family Thomas Ruskin, president of CMP protective and investigative group, implores parents to perform a background check on nannies. It is an imperative for ensuring the safety of your child. Your choice of a nanny or babysitter can place your child at risk. Ruskin shares this information with parents. »» Internet deals that offer $99 background checks do not offer parents enough information on a candidate. These

Internet background checks only review databases and not actual criminal histories. Parents should use a firm that can investigate criminal records, DMV records, check immigration history and verify an individual’s Social Security Number. »» Nanny cams are a popular choice for parents who want to check on their child. Parents can review the video feed remotely and see how both nannies and their children behave while they are away. Be aware of the laws that apply in your area to taping conversations without the knowledge and consent of parties before proceeding. You may want to address this with a potential hire prior to employment. »» Be clear with potential hires that you will require a background check for employment. For potential hires with an unsavory past, they may choose to turn down an offer rather than undergo the background check. This is one way to deter an undesirable candidate. »» Choose a nanny from a nanny agency. Although not a guarantee, nannies with a checkered past will avoid working through an agency. Agencies are responsible for running their own background checks on employees. If interested in a candidate, request a copy of their report. As a parent, do some free sleuthing via the Internet. The INA has a list of search recommendations for parents that include verification of identity, employment, educational history, licenses and performing a sex offender registry search. Review more of their suggestions on nanny.org. eNannySource is a recommended background check service that allows parents to add in services to three different packages for a tailored solution. Keep in mind that hiring through a verified agency or using a firm will do much of the footwork for parents, offering additional peace of mind and less hassle for parents.



Is it the Right Time

to Sell Your Home? by Ashley Lewis



pring is upon us, and that is a busy time of year for real estate agents. Many people want to sell their home at this time of year because there is more demand, and with children, you have the Summer to move and get into that school system you have always wanted. Also, if the demand is high, you can secure more equity. So, what should you consider before making the decision to sell? Timing the market is virtually impossible. Unless you are in the business of real estate, you should only sell after you have considered various issues. While a home is an investment, it should usually be considered a long-term investment when financing is involved. So, before you sell, consider the following questions:


Why are you selling?

Are you trying to make money? Has your income changed? Have your kids gone off to college and you want to downsize? Have you built up equity and savings and want that larger home? Are your kids moving up in school and you want a new school system? Have you outgrown your home and do you need more room, or could you simply de-clutter? Are you moving for a job or retirement? Before you decide to sell, you need to decide why you really want to sell so that you can sit down with your agent (if you aren’t selling by owner) and discuss your goals.


Are your finances in order?


Is your home ready to sell?


What is the current market?

What is your loan payoff, and what is a good estimate of your home’s value? If you sell, do you have enough equity to purchase that next home with 20% down so you don’t have private mortgage insurance? Do you know what interest rates are and what your payment will be on your next home? Can you afford it? Do you have the funds for moving expenses and any other costs associated with selling your home, i.e.; closing costs, fixer upper costs, etc.? Are you pre-qualified for a loan?

Most individuals who are not in the real estate business have an inflated value of their home and do not see the blemishes. A good real estate agent will point those out to you: painting (inside and out), proper staging, curb appeal, roof, etc. All of these items need to be resolved before you put your home on the market so that you can maximize the value of your home.

Have you or your agent researched the value of homes which have sold recently? Are there any homes for sale near you, and how do they compare to yours? These are issues you and your agent have to know before you determine the list price. If you have an agent, make sure he/ she has experience in making these determinations and that he/ she enlists the help of other agents to provide an independent opinion. If you list your home too high, it can sit on the market for months with no activity.


Are you prepared to have your house for sale? When your house is for sale, you have to be prepared for


inconvenience. People will want to come see the house, and they will want to come on their time, not yours. If you have an agent, you will most likely have an open house, and that means you and your family must be gone for several hours during the open house. If you have kids or if you are messy, the house must be kept clean in the event someone is coming to visit. A dirty, messy house can mean a lower price.


Do you know if you want to sell first before buying?


Finally, consider how long you are willing to have your home on the market.

This seems like an elementary situation, but if you make an offer on another house before selling yours, you will have to do so on a contingency of the sale of your house unless you have plenty of cash on hand. Or, you can sell your house before finding a new one, but if that happens, where will you live? You could rent the house back from the purchasers if they allow, or you could move into an apartment or with family members. This decision must be considered before putting your home on the market.

If it doesn’t sell for several months, it may be that it’s just not the right time.

5 Things

I Wish I Had Known Before I’d Bought My House by Tatum O’Brien uying your first house is right up there with many of the milestones of American life: buying your first car, choosing a college, getting married and having a baby. All require (or should require) a considerable amount of thought to get it right. First-time homebuyers often spend a lot of time researching their purchase and educating themselves on the local real estate market, yet mistakes are still made. Hindsight may be 20/20, but here are some things many homeowners wish they had done before they jumped into their first mortgage.


you rented, such as: »» Larger utility bills »» Home repairs »» Lawn maintenance »» Homeowner’s insurance »» Property taxes To be as prepared as possible, start building your emergency fund for several months, or years, before you actually take the plunge into homeownership.

Shopped Around More for Their Mortgage Started Saving For a Down Payment – Earlier Basically, the earlier you start saving for that down payment, the better. If you want to avoid paying private mortgage insurance (PMI), you’ll likely need a minimum of 20% of your future home’s value for a down payment, and on a $200,000 home, that’s $40,000. Even if you aren’t planning to buy any time soon, you’ll put yourself in a much better position if you start stashing $50 or $100 a month away now.

Fallen in Love Too Soon Like getting married and having a baby, buying a home just isn’t something you should rush into. There are lots of things to consider when purchasing a home, and you can often benefit by looking in different areas and neighborhoods before you make your decision, which takes time and patience.

Built an Emergency Fund As many first-time homebuyers find out, buying a home isn’t just “buying the house.” There will be all sorts of new expenses appearing in the monthly budget that you may or may have had when

The best way to get a good mortgage rate is simply to shop around. Don’t think your best option is necessarily your current bank, there are many choices. You’ll likely be surprised at the variety of rates that you will find. Saving even half a percentage point may shave thousands of dollars off the price of your home in the long run.

Tried to Make Too Many Changes, All at Once No home is perfect, and there will be some things you can live with and others you can’t, as well as some things you can change, and others that are there for the duration. For instance, you can’t change the location of a home, so remember that you’re not just buying the house, you’re buying the neighborhood—remember the old saying, “you don’t just marry the person, you marry their whole family?” It applies when buying a home too. Always explore the surrounding area before you commit, even if you think it’s just your “starter home.” The problem is, not many young families can afford their “forever home” right away, or for many years, because even as home prices and debt loans have risen, paychecks haven’t increased at close to the same rate.


Electrical Safety Tips for Your Home by Craig Kelley


any homeowners seem to relegate the subject of electricity safety in the home to those homeowners who have curious infants and small children who might stick a finger or metal object into an electrical outlet and be electrocuted. However, all homeowners should understand there are many risks involved with electricity in the home, so education at any age can be lifesaving. Electricity is powerful energy, and if it is not safely harnessed it can cause electrical fires and damage to human beings, whether directly or indirectly. Electricity can hurt humans through various means, including shock, burns, neurological damage, psychological damage, and ventricular fibrillation (heart muscle cells are moving independently) of the heart that can lead to swift death. A human being who encounters only 80 milliampere (mA) can have their heart muscle seize up and be electrocuted (death by electrical shock). So one might ask just what a homeowner can do, other than the obvious, to prevent electrical related injuries in the home? For starters, the homeowner can equip electrical outlets with tamper-resistant receptacles (plastic safety plugs) to keep those curious kids from sticking fingers or objects into the outlet. One can also look out for damaged, loose electrical cords and replace them right away, and remember that older homes need electrical inspections to assure things are up to current standards. The homeowner should never put rugs over extension cords or run them across doorways or walkways. Actually it is wise, if possible, to forego the use of extension cords altogether by having a qualified electrician install a sufficient number of accessible electrical outlets. A smart individual does not approach the manufacturer’s product instructions as mere suggestions when plugging new appliances or products into electrical outlets, and also knows not to plug too many devices into one outlet. High-wattage products should, in fact, hog an electrical outlet all to themselves as much as possible. One may want to call a qualified electrician when electrical outlets are warm or are frequently tripping breaker circuits or blowing fuses. One should also pay attention to whether certain product electrical cords become warm when plugged into electrical outlets (think laptop computers, hover boards and other electronics) and refrain from leaving those products plugged in unattended. Household occupants are wise to assure that lamps are sitting on flat surfaces and are not too close to things that light bulbs could burn, such as curtains or other fabrics. A lamp or fixture should never contain a light bulb with wattage higher than called for in the manufacturer’s instructions and warranty to prevent even further hazard with electrical lighting. The homeowner should also check out all ceiling fans to be sure they do not slowly wobble, as this indicates the fan is out of balance and installed on a box not able to support the product. One should also be extremely cautious when using older refrigerators that can have leaks, worn-out insulation in the internal wiring, and/or a defrost circuit, as these old appliances can be dangerous for condensation build-up on the floor and electric shock. In addition to paying attention to the above safety tips, the savvy homeowner should be sure to have a competent electrician install ground fault circuit interrupters (GFCIs) in kitchens,


bathrooms, laundry rooms, basements and outdoor areas containing electrical outlets. In addition, it is wise to have an electrician install arc-fault circuit interrupters (AFCIs) to protect electrical outlets. In the unwelcome event of an electrical fire in the home, it is absolutely essential that homeowners and occupants understand that water should never be thrown on an electrical fire, and that there is a time to fight an electrical fire with a chemical fire extinguisher and a time to flee (when in doubt, get out!). Once educated on electrical safety tips in the home, it can be the difference between life and death for the newly educated electricity aficionado to educate the rest of the household members old enough to understand basic safety tips. Even children can be taught things like the rule to never have wet hands or a running sink while also touching an electrical switch, outlet or product. The bathroom can be an especially dangerous place for electrocution that comes from a small appliance, such as a hair dryer, falling into a running sink or bathtub. Electricity and water never mix and this is where those ground fault circuit interrupters (GFCIs) discussed above come in handy. Children and other members of the family can also be taught to never stick anything into an electrical outlet that is not meant specifically for plugging in, and/or without adult supervision. It is even wise to educate household members to avoid bathing, showering or talking on landline telephones when there is lightning outdoors. Finally, perhaps the wisest of all advice for all household members regarding electricity danger reduction is to hire an electrician rather than allowing do-it-yourself electricity installations and fixes by novice, unlicensed individuals or the best of intentions can go deadly wrong.


Spring Cleaning ­­­by Brittany Monbarren



Use the proper supplies.

Be afraid to ask for a little help.

Avoid taking on too much.

Miss the small areas.

Start with a plan to help you stay on task.

Try to do it all in one day.

Work while you have the motivation, and when you start to get tired and not work to your full effort, take a break.

Clean the refrigerator’s condenser coils.

Forget to dry the fan blades thoroughly. Damp blades attract dust.




Mix chemicals.

Leave items to go to charity sitting around your home.

The Ins and Outs of Structured Attorney Fees by John T. Bair For attorneys who want to create a supplemental retirement fund, manage the cash flow of their law firm, or protect themselves from being bumped into a higher tax bracket, structured attorney fees should be considered as a viable investment option. In Richard A. Childs, Et al. v Commissioner of Internal Revenue, the 11th Circuit U.S. Court of Appeals affirmed that attorneys who elect to structure their fees will not have to pay taxes on those payments until the year the income is received. This allows attorneys to spread out their income, rather than getting hit with a large tax bill in one year. At what point do I need to decide to structure my fees? You must elect to structure your fees prior to settlement; it must be included in the settlement agreement. You can’t have constructive receipt of the money to be structured. It should be paid to the life insurance company via an assignment company. What factors should I consider? There are a number of factors to take into account when deciding whether or not to do an attorney fee structure:

»» Health »» Present financial needs and goals »» Future needs and goals (college, retirement, etc.)

»» Risk tolerance


737 Main Street Suite 100 Buffalo, NY 14203 (716) 883-1833 (855) 836-2676 www.milestoneseventh.com

What if I worked on the case with another attorney? Am I still eligible? Yes, you can still structure your fees. The stream of payments can be split among more than one attorney. Should more than one decide to structure, each gets their own unique payment schedule. Is an attorney fee structure flexible? Yes. You should choose a plan that best fits your individual needs. How is the structure funded? It can be funded with an annuity from a highly rated life insurance company, providing the attorney with fixed payments. Certain firms also offer a product that uses a Single Premium Immediate Annuity (SPIA) to purchase a whole-life insurance policy, which may offer a greater return than a traditional annuity. How are payments made? Payments can be made either to you or to your firm. Fee payments can be affected by a number of factors, including the type of incorporation the firm has (e.g. LLC, PC, etc.), dissolution plans of the firm, tax advantage, etc.

»» Age

»» Tax bracket

Can I elect to do a fee structure if my client elects to receive their settlement proceeds in a lump sum? In most cases, you may structure your fees regardless of what your client decides to do.

Disclaimer: Milestone Consulting, LLC does not provide legal or tax advice. Please consult an attorney and/or estate planning expert if you have questions regarding the legal or tax implications of your structured attorney fees.

Milestone Consulting, LLC is a comprehensive settlement planning and management firm. We believe that injured plaintiffs and their families deserve strategies designed to ensure a lifetime of financial security. Our consultants are licensed in all fifty states to provide guidance on settlementrelated issues including government benefits preservation, trust planning, Medicare SetAsides, wealth preservation and annuities. We also provide mediation support to assist the plaintiff in reaching a settlement that will

meet their present and future medical and financial needs. In addition to our work with plaintiffs and trial attorneys, we actively support a number of civil justice organizations, including The Injury Board, the American Association for Justice, the Workers’ Injury Law and Advocacy Group, and statewide associations in New York, Pennsylvania, Massachusetts, Rhode Island and Washington, D.C. For more information, please visit our website at www.milestoneseventh.com.

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