Pills and medicine

What It Takes To Get A New Drug Approved

How many of us trust our federal government? According to Pew Research, only 19% of Americans today say they can trust our government to do what is right “just about always.” So, if we don’t know it we can trust our government, how do we know we can trust our government agencies? Take, for example, the FDA. While we’d like to think that the agency responsible for approving the drugs that we bring into our home and give to ourselves and our family holds itself to higher standards than the government for which it works, how can we be sure? Let’s take a look at the prescription drug approval process in the US to see just how trustworthy it is.

The Lowdown
According to a report published in the medical journal JAMA, 32% or FDA approved drugs already in use between 2001 and 2010 “were affected by a postmarket safety event,” meaning the safety of these drugs was questionable even though they had already been placed on the market. Events varied between announcements about recently discovered side effects to outright withdrawal of drugs due to reports of fatalities. In tandem with the release of this report comes the consideration by the Trump administration to streamline and shorten the approval process. According to internist Joseph Ross, one of the study’s authors, ” Our data show that there are some cautionary predictors of increased likelihood of the FDA taking a safety action in the postmarket setting. This information should be taken into account as the FDA considers conditions of approval and when further clinical trials should be required to better understand drug safety.”

Researcher working in lab

Revelations of the JAMA Investigation

  • Of the 222 FDA approved drugs 71 led to a safety event with three resulting in outright withdrawals. Sixty-one of these drugs qualified for “black-box warnings,” or warning labels posted on the packaging of the drug framed in black rule “designed to call attention to serious of life-threatening risks.”
  • Psychiatric treatment drugs and biologics that were given accelerated approval and drugs that got approval around the time of a regulatory deadline were most likely to require warnings after hitting the market.
  • These events highlight “the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

Especially affected by these findings are older Americans, as many of the drugs spotlighted in the study have potential risks that won’t come to light for years. For example, revolutionary treatments of ailments such as rheumatoid arthritis, cancer, and Crohn’s disease are among those currently being researched for the long-term impact on the population because accelerated approval drugs are considered more urgently needed, research about these drugs often takes a backseat and may not qualify for approval in time to meet the needs of more mature patients.

Implications
President Barack Obama signed the 21st Century Cures Act last December to speed up the approval process for certain drugs, a process President Donald Trump referred to as “slow and burdensome,” claiming it was hindering medical advances from reaching needy patients. According to Ross, “Speeding up approval even further will not be without consequence. There will be more uncertainty at the time of approval, endless that is known about a new therapy’s safety as well as its anticipated benefits.

Are you shocked by these findings? Not surprised? Let us know what you think and what you think should be done. We want to hear from you.

Woman with dog at beach

Go Outside To Relieve Anxiety

Technology seems to be determined to deliver everything to us at the push of a button. We can shop, watch movies, eat, date, and even go on roller coasters all within the comfort of our own home. However, if life has become so easy, why do one in five women claim they suffer from anxiety all or most of the time, a figure almost double what it was two years ago? Perhaps it is because they don’t get outside often enough. Coinciding with the advent of Mental Health Awareness Week, ending on May 16, British Military Fitness has released research findings showing a direct link between outdoor exercise and the prevention of anxiety and depression. Could it be that the very technologies designed to lessen stress are really exacerbating it?

The Stats
Not only has the number of women suffering from anxiety been on the rise in the last five years, 22 percent admit being caught up in money worries and concern over the welfare of those close to them. This number has soared since 2009 when a survey by the Mental Health Foundation reported only 12 percent admitting to feelings of stress. In addition to the ladies, the charity Living with Anxiety found that over 50% of all people say they get more anxious now than they did in the past., and in a poll of 2,300 people by YouGov, almost a fifth reported feelings of anxiety about money, debt, and finance.

Anxiety
While anxiety can be a positive and even motivating emotion, constant unease can lead to panic, obsessive behaviors, and social phobias. Some sufferers resort to self-medication, including drugs, alcohol, and overeating, however, there are more healthful ways of coping.

Friends cycling

Benefits of Outdoor Exercise
Research by British Military Fitness shows a direct correlation between outdoor exercise and decreased stress levels. Of 1,000 people surveyed, 53.3 anxiety sufferers reported feeling better after spending time outdoors. Thirty-five percent said exercise boosted their moods, eased nervous feelings and lowered built up angst. According to Rob Love, managing director of BMF, “Everyone has feelings of anxiety at some point in their lives, whether it’s preparing for a job interview or managing a household. The research is encouraging, as it shows there is a recognition that being outdoors and participating in physical activity does help with both anxiety and depression.”

Get Moving
If you’re finding life becoming overwhelming, exercise may be a good way to help you unwind. Exercise releases invigorating chemicals in the body that can have a positive effect on your mood and leave you feeling more relaxed. Added bonuses include a more toned body, higher levels of energy and better sleep. Exercising to reduce stress does not have to be stressful! You don’t have to commit to hours at the gym or high impact activities. A quick stroll or just walk upstairs instead of taking the elevator are both easy ways of sneaking a little movement into your day. Leisure activities can also be a fun way to get your heart rate up. Consider taking a dance class, or playing some golf or tennis.

Are you exercising to stave off depression? Let us know how you lighten up when things get heavy. We love to hear from you!

Tequila

Tequila May Improve Bone Health

There is drinking, and then there is drinking tequila. For the partying crowd, tequila is “the hard stuff,” the stuff you go to when you don’t just want to drink, you want bragging rights. You want a lasting story that you and your friends will talk about for years after. For the gentler crowd, tequila is “the good stuff.” A drink that is meant to be savoured and appreciated rather than abused. However, while tequila drinkers may have their separate reasons for drinking the stuff, it is probably a pretty safe bet that neither group is thinking of their bone health.

Tequlila and Bone Health
Perhaps learning that tequila comes from a plant will make you more likely to accept the possibility that it actually might be good for you. A study done by the Center for Research and Advanced Studies in Mexico has found the there are actually substances within the tequila plant that can improve the absorption of magnesium and calcium in the body. The results were obtained through a study of mice with induced osteoporosis, a bone-weakening condition. When given agave fructans, which are the non-digestible carbohydrates from the blue tequila plant, the mice displayed a 50 percent increase in a protein, which indicates new bone growth, and a noted increase in the size of the existing bone. According to research leader Dr. Mercedes Lopez, “The consumption of fructans contained in the agave, in collaboration with adequate intestinal microbiota, promotes the formation of new bone, even with the presence of osteoporosis.”

Less Likely to Cause Hangovers
Well, maybe tequila has not quite made it to superfood status, but some pretty healthy people are drinking it. One California-based Ashtanga yoga instructor says, “I’d been a strict vodka drinker for years because I wanted to cut calories. Now I feel like I’m taking a vacation, a year abroad with tequila. My understanding is that blanco or silver tequilas are the way to go – they’re cleanest and don’t give you a hangover.” Blanco tequilas are the purest type, made of 100 percent agave. Says Jason Eisner, beverage director at Gracias Madre in West Hollywood says, “Jose Cuervo-what most Americans think of as tequila is 42% corn syrup which gives you a terrible hangover.” Herbalist Emily Han explains, “Blanco tequila contains a lower level of congeners than dark spirits and red wine. Congeners are substances like acetone and tannins that are produced during fermentation and studies show they may worsen hangovers.”

Friends toasting

Other Health Benefits
Need some help digesting? Experts say that a shot before a meal can stimulate the appetite and one after a large dinner can help digestion. According to chef Sue Torres, ” The sugars are simple, so they break down easily in your body.” Adds Roger Bailey, head bartender at Filini in Chicago, “Tequila has a component that can, in moderation, aid in lowering cholesterol.” Studies have shown that tequila may be able to break down dietary fats which can lower the levels oaf bad cholesterol. Bailey adds, “Tequila will alleviate mild strain, tension, and headaches, although, he adds, “I don’t suggest slamming tequila to get rid of a migraine.”

So, what do you think? Headed for Margaritaville? Let us know your thoughts on the new “health beverage’

Woman eating pills

Antibiotics May Be Linked To Miscarriage

According to the March of Dimes, up to 10% of expecting moms will get a urinary tract infection or UTI, during their pregnancies. Of these, about 25%, if left untreated, can develop into kidney infection, which can life-threatening for both mother and child. However, the good news is that as long as a UTI is caught early enough, it can be easily treated with antibiotics, right? Well, yes and no. While antibiotics can be a safe and effective treatment for UTIs, there are some new revealing studies that pregnant women will want to know about before taking them.

Antibiotics and Miscarriage
A recent study published in the Canadian Medical Association Journal has found some eye opening links between antibiotics and miscarriage in pregnant women. The prevalence of UTIs in pregnant women and their likelihood to be treated with antibiotics make this an issue of concern. A study done by researchers at the Universite de Montreal collected data from 182,369 pregnant women in Quebec between the years of 1998 and 2009, 8,702 of which ended in miscarriage before the 20th week of pregnancy. Of these, 16 percent occurred after the women took antibiotics.

Antibiotics to Avoid
Although all of this may be enough to scare you off antibiotics during pregnancy entirely, you should know that there are some medications which are higher risk than others. The most dangerous drug classes are tetracyclines, which is used as a treatment for acne, and quinolones, which can be used on a variety of infections, and was a common culprit in causing miscarriage, increasing its likelihood by three times. Clarithromycin, prescribed for pneumonia and bronchitis multiplies the risk by two. Azithromycin, used for infections of the respiratory system and some STIs, increased the of miscarriage risk by 60%, while metronidazole, used to treat bacterial vaginosis, increased the chances by 70%. Trimethoprim and sulfamethoxazole upped the risk by 25%.

Expert Advice
While it may seem as if there are no safe alternatives, Sherry Ross ob-gyn at Providence Saint John’s Health Center has some insight on the subject: If you notice symptoms of UTI, you definitely want to inform your doctor; if left untreated they can lead to preterm birth, kidney infection, and preeclampsia. Your doctor should recommend going with safer antibiotics, such as nitrofurantion, cephalosporin, penicillin, and erythromycin. All of these are safe antibiotics with a broad range of uses. Ross says, “Most important is to make sure you discuss the pros and cons of UTI options with your obstetrician and ways to avoid recurrent infections during the rest of the pregnancy, If you are trying to conceive and are unsure of your pregnancy status, you would want to make sure you are taking the antibiotics not associated with an increase in miscarriage risk.”

Have you experience UTI during pregnancy? How did you handle it? What’s your expert advice? Let us know!

Friends hugging

Hug It Out To Slow Down Aging

Have you heard of professional cuddlers? For about $60/hr, you can hire someone for a platonic cuddle up without the complications of a relationship. In fact, some of the services even offer cuddling parties. Sound a little creepy to you? Well, what if you found out that hugging can help to slow down the aging process? According to the University of California, Berkeley, people who don’t hug age faster. Ready to cash in your $60? Let’s look at the effects of oxytocin on the aging process.

The Love Hormone
Oxytocin is also known as the “love hormone” or “trust hormone, and it gets released when people let down their guard and participate in a good hug. As we age and get fewer hugs, the levels of the hormone drop and muscle loss are one of the major side effects. In fact, science shows that we lose five percent of muscle mass per decade once we reach our thirties. In the study at UC Berkeley, oxytocin was injected into older mice who were showing signs of aging and muscle loss. Within nine days of the injection, their muscle mass improved to within 80% of that of the younger mice. Wendy Cousins, coauthor of the Nature Communications study says, “This is good because it demonstrates that extra oxytocin boosts aged tissue stem cells without making muscle stem cells divide uncontrollably.”

Friends laughing

Oxytocin Increases Happiness
Paul Zak, PhD, hypothesized that there was a direct correlation between well-being and happiness and oxytocin, at least for women. To test his theory, he drew blood from 60 female college students after receiving a gift from a stranger of $24. The women were given the option of returning a portion of the money or keeping it. The women were also required to fill out a survey on their satisfaction with life. Results showed that women who showed a larger increase in oxytocin after receiving the money reported being more satisfied with life and were also more likely to share their money with the stranger. They also tended to be more trusting. According to Zak, “Those with higher oxytocin had more sex with fewer partners,” indicating a likelihood to form more long lasting relationships and be liked by others.

Oxytocin Increases Generosity
Another of Zak’s studies found that men treated with oxytocin were more likely to donate money after watching public service ads. Forty-one men were divided into two groups, one of which was given the hormone, and the other of which was given a placebo. They were then shown public service ads on topics such as smoking, drunk driving, and global warming. Zak says, “Those on placebo donated to 21% of the ads, those on oxytocin, 33%.” The men given the hormone donated 56% more money than those given the placebo.

Oxytocin and Social Anxiety
Researcher Jason Yee, PhD, says that oxytocin can help relieve anxiety in social situations. Prairie voles are known to form strong monogamous bonds. Yee exposed the animals to a brief period of stress, and then gave them oxycontin to reduce anxiety and compared the recovery from stress in the animals who recovered alone to those who recovered cuddling with another prairie vole. Yee found that those who were assigned a partner showed less anxiety, and were less likely to try to escape from their cage.

What do you think of professional huggers? Yay or nay? Let us know what you think about paying for hugs.

Woman using barbells

Use Muscle, Don't Lose It

We’ve all seen it. The celebrity weight transformations. A celebrity gets a role and that calls for an actor with a muscular physique and all of a sudden they’ve transformed into the “Incredible Hulk,” seemingly overnight, adding masses of muscle to their formerly moderate frames, only to slim down just as quickly to normal or even emaciated proportions depending on their next role. Of course they will openly discuss how they “bulked up” or “slimmed down” with tales of excessive carb, consumption and exhausting workouts or stories of food deprivation worthy of a homeless orphan.

However, while we are used to the seemingly impossible becoming commonplace in Hollywood, we hope for a more stable body weight for ourselves. When we build muscle, we generally hope to maintain it, but we need to use it to make sure we don’t lose it.

The Bad News
If you don’t start exercising now, your muscles will shrink by the time your are seventy. Two recent studies found that the atrophy of muscles previously though to be a normal part of aging is not inevitable.

One study used MRI snapshots to compare muscle mass in the mid thighs of athletes aged 40 to 81. Images revealed not much difference between the younger and older athletes and found very little decrease in mid thing muscles with age. In contrast, in healthy but sedentary 70 year old, the results were very different, showing a significant decrease in muscle mass.

Another study looked at the “motor units” of the leg muscles. Motor units are the basic units of the muscles, each of which is connected to a single neuron. It is believed the part of the general weakening that occurs with age is attributed to the atrophy of the motor units. The study revealed a close similarity in the number of motor units of 60 and 20 year old runners. However, this did not apply to the arm muscles, with older runners and non runners alike experiencing similar decline in the motor units of the arms.

Woman with prominent biceps

The Good News
The loss of muscle mass, also known as sarcopenia, can be managed with exercise. Exercise stimulates the release of hormones crucial to healthy muscle mass, such as the growth hormone, crucial to the mechano growth factor. Exercise can also prevent the loss of essential bone and muscle associated with aging.

Although aerobic exercise is great for the cardiovascular system and effective in keeping down fat levels, it is only mildly helpful in maintaining the lean body mass you already have. When it comes to the preserving and increasing lean mass, resistance training is the way to go. The Federal Centers for Disease Control and Prevention advises strength training, such as using weights, machines, bands, and other devices to promote mobility, improve fitness, and increase bone density.

The Big Four For Muscle Building
Because your body is made primarily of “push and pull” muscles, it is important to focus on exercises that focus on those movements. The squat is a great whole body “push” exercise and should be coupled with a whole body “push-pull” like the deadlift, which incorporates core and lower body muscles. For the upper body, the bench press and barbell row are the two main lifts to incorporate into your strength training routine. Doing these will let you minimize finishing exercises for the abs and calves.

How are you using your muscles? Let us know! You’re looking great!

Child painting different colors on a sheet of paper.

Resveralife Live Well: Can Colors Help You Lose Weight?

Think you’ve tried absolutely everything to lose weight? It might be time to reconsider. You know that the key to sustained weight loss is a sensible, healthy diet and regular exercise. However, perhaps you want a bit of a jump start on your weight loss or you want to lose those stubborn last five pounds. New research indicates that the color of your plate and food may help you reach your weight loss goals. This Resveralife Live Well Guide shows you how colors can help you to lose weight.

Woman enjoying a color therapy session in her bath.

Color Therapy
Color therapy, also known as chromotherapy, has been acknowledged for centuries as a way of healing the body. The National Center for Biotechnology Information provides a cursory view of the hypothesis behind chromotherapy:  “The human body, according to the doctrine of chromotherapy, is basically composed of colors. The body comes into existence from colors, the body is stimulated by colors and colors are responsible for the correct working of various systems that function in the body.” Every organ in the body has a distinct color. In addition to our body being composed of color, the atoms, cells and organs co-exist in the form of energy, and each has its vibrational or frequency energy. Each organ and energy center harmonizes and vibrates with the frequencies of these colors.

Exotic image of a food dish with red tomatoes and greens in the background.

Why Color Matters to Your Waistline
Okay, so our bodies are a veritable rainbow of frequencies and energies, but what does that have to do with losing weight? Researchers suggest that colors create fields of energy or electric currents that activate hormonal and biochemical processes in the human body. Some colors are more likely to increase our appetite while others decrease our appetite. So what colors help your weight loss quest and which ones can be harmful? According to ColorMatters, “blue is an appetite suppressant.” Experts theorize that this is because blue is not a common color of natural foods. With the exception of blueberries and some types of potatoes, there are very little naturally occurring blue foods. Because of this, experts believe that we are less likely to associate blue with hunger. To use the color blue to your advantage experts recommend a few tricks.

  • Add blue food dye to your food to decrease the amount you ingest.
  • Swap the light bulbs in your fridge to blue ones. This will help decrease your desire to snack when you open the doors.
  • Use a blue plate for your meals.

The color most likely to derail your progress is red. Red increases your appetite, so get rid of red dishes or placemats and use the more mellow color of blue. It is worth noting that red also increases metabolism as well as appetite, so it can be useful when used properly. Consider using red water as a tool in your healthy eating routine. The LiveStrong organization suggests making red solarized water by “wrapping a clear glass with red cellophane paper and putting the glass in the sunlight. After a few hours, the water will be energized with the color red and ready to drink.” Using color therapy may just be the trick you need to help you with your weight loss mission.

If you aren’t quite ready to jump into dyeing your food blue, you can still use color to your advantage in the kitchen. Use plates that contrast highly with the food that you are eating to help you be more satisfied with less food. For instance, keep salads away from green plates and spaghetti dishes away from red. Picking a plate that contrasts with your food can be a great start to using color to help you lose weight.

 

online shopping

Resveralife Reports: Consumer Research a Threat to Retailers?

We live in an age of instantaneous information, connection and satisfaction. We get what we want, when we want it. As consumers, it has always been important to be informed when it comes to our purchases. We want to know what we are buying, what benefits the item or service might have, any disadvantages that the item may have and what performance we can expect from the thing we are spending our hard earned money on. Whether it is a silk camisole or a washing machine, we like to be savvy shoppers. But does our increased availability of information and our knowledge of products threaten retailers?

Recently, Google partnered with Ipsos MediaCT and Sterling Brands to see what impact technology has on consumption and shopping habits. Included in this study was the question of whether or not consumer research is damaging to retailers. The common belief among brick and mortar retailers is that the primary reason we go into stores is simply to conduct a transaction. Retailers assume that we have already completed our research and as such, that we are fully informed about their product. They assume we are there only to pay for our items. However, the research suggests that the retailers who believe all we want is a sales transaction are doing damage to themselves.

The data gathered by Google, Ipsos MediaCT and Sterling Brands, suggests that as consumers, we expect more than ever from our retailers. We still visit stores, and online shops, to compare and to stimulate interest in items. The research suggests that while we are more informed than ever, we still look to retailers to be an authority on their products and to provide use with a shopping experience. Google, Ipsos MediaCT and Sterling Brands found that just because we perform searches and gather information does not mean that we are turning our backs on retailers. We simply want more out of them. We visit our favorite stores not only because we like the merchandise that is sold there, but also because we enjoy and savor the shopping experience in these stores.

Retailers would do well to take heed of this information. The majority of us visit stores to get an idea of what we want to buy prior to conducting research. Once we have seen the item, then we go into detective mode and try to learn as much as possible about what we intend to buy. Our research doesn’t necessarily hurt retailers, though it does affect what we want from them. Because we can pull together so much information on a product, we expect our retailers to be able to still tell us more. Why buy something when the retailer seems less knowledgeable about the product than we are? We expect retailers to be experts in their products and services. We also anticipate that retailers will provide us with a personalized shopping experience.

Being an informed consumer is important, and some of the burden certainly does rest on us. However, retailers also need to remember that customers want more than just information and details on products. We want to feel valued and important. When it comes to shopping we want more than product specifications, we want to have an enitre experience when it comes to shopping.