woman sitting on bathroom counter

Understanding Your Body’s Response To Hormones

Hormones, can’t live with ’em, can’t live without ’em. When you’re a teen, they hit you like a mac truck, wreaking havoc on your formerly clear skin and relatively easy going parents. Then, just when you thought you’d got them under control, the 40’s hit, hormone levels go down and you’re wishing for just a smidgeon of the estrogen you had in high school. Hormones can be a tricky thing, and sometimes they can seem to have a lot more control over your skin than you do, but there is a way to make peace. Read on for a little insight on hormone fluctuations, what to expect, and how to deal with them.

The Teen Years
When girls hit the ages of around 12 or 13, the introduction of hormones begins. The female body starts to produce estrogens and androgens in high quantities and the skin is impacted. Estrogen is responsible for the “female aesthetic”, causing breasts to develop and giving the hips their curves. In the skin, estrogen decreases the size of pores, giving it a smooth surface and builds elastin and collagen to give skin elasticity and maintain moisture. However, it is the male hormones which lead to the oiliness. Androgens, including testosterone, stimulate hair growth, enlarging pores and boosting sebum, the oily substance in the skin. The result? Acne.

The 20’s and 30’s
The twenties and thirties are definitely the best it gets as far as hormones are concerned. Estrogen peaks and the testosterone boosts sebum, giving skin radiant glow. The hormones are in balance.

The 30’s and 40’s
Of course, nothing gold can stay. After the estrogen effect peaks at around the age of 25, it begins to drop, slightly in the 30’s and more noticeably in the 40’s. Production of collagen and elastin decrease and the skin begins to lose elasticity, affecting the aging skin in a far greater capacity than sun damage. By the late 40’s women enter perimenopause, the purgatory between ovulation and menopause. Hormones cycles change and women may notice a resurgence of acne, an increase in facial hair, and thinning hair on the scalp.

50’s and Up
Most women have reached menopause by the age of 50. Estrogen and testosterone production declines, and with it, the skin manufactures less collagen and elastin. In fact, according to a study in the Venus Week, collagen production declines 2.1% every year in the 15 years following menopause, leading to a 30% decrease in collagen between the ages of 50 and 65. Hot flashes may occur and the skin will get drier, thinner, and more wrinkled.

Controlling Hormones
Because hormone fluctuations are often the result of excess weight and lack of exercise, a good dietary and exercise regimen is key in maintaining hormonal balance. However, underweight women are also at risk for hormonal imbalances. Experts advise aiming for a body mass index between 20 and 25.

Women in their 20s can control acne by using face cleanser including salicylic acid, while older women with decreased skin elasticity should use an exfoliant weekly and an antioxidant containing moisturizer. Retinoids can help with wrinkles, and all women should wear sun screen, as sun damage can intensify unwanted changes in the skin.

The first step to finding treatment is diagnosing the problem. Says Rebecca Booth, MD, “Women must first understand the effects of their hormones on the skin and overall health to seek lifestyle changes to navigate these natural fluctuations. With the power of knowledge, they can seek solutions to achieve the maximum flow of hormonal balance all month long and all life long.”

Are your hormones wreaking havoc on your skin? Let us know how you’re coping. We love to hear from you.

woman drinking water

Hydrogen Water Is The Latest Health Trend

These days it may seem like the water bottle is the new black. That, along with the yoga mat, may be the best ways to accessorize your athleisure. The water companies comply. They have answered the call by giving the consumer a variety of waters, stylishly packaged, claiming additional nutrients  capable of everything from relieving stress to improving brain power. However, skeptical though many of us are, every once in a while products do come along that live up to their claims, and it is important that we not let our judgmental attitudes prevent us from reaping the benefits. Hydrogen water is one of the latest to be making some miraculous health claims. Is there anything behind them? You be the judge.

Antioxidant and Brain Damage Prevention
Can hydrogen water help to fight oxidation that causes brain damage? Science says molecular hydrogen (H2) protects tissues and cells from oxidative damage by reducing the oxygen species ROS.

Studies on rats show hydrogen water can prevent the onset of Parkinson’s disease and has been shown to prevent cognitive impairment associated with Parkinson’s disease and dementia.

Another Parkinson’s related study on mice, showed the water capable of preventing the development and progression of neural degeneration associated with the condition, and a study on patients with Parkinson’s seems to support those findings. Hydrogen water was found to reduce neurotoxic damage with no adverse effects at high dosages.

Improves Mood Disorders
An additional rodent study, showed hydrogen water was able to restore the natural growth of brain cells in mice. Because antidepressants exhibit similar properties, there is speculations that hydrogen water may be able to improve depression and other mental disorders.

Anti Inflammatoy
A study of patients with rheumatoid arthritis showed that drinking .5L/day of hydrogen water for 4 week resulted in remission for all patients, with 20% becoming free of inflammatory symptoms.

Reduces Motor Deficits, Muscle Disease and Degeneration
An experiment on young athletes showed that drinking hydrogen water reduced the build up of lactic acid during strenuous exercise, resulting in a decrease of muscle fatigue.

In study on mice with the muscle disease Duchenne muscular dystrophy (DMD), showed that hydrogen water prevented the gain of abnormal body mass and increased antioxidant production. This indicates a potential use for hydrogen water as a treatment for muscular dystrophy in patients with DMD.

Prevents Metabolic Syndrome
Hydrogen water may also be able to help those suffering with type 2 diabetes. A study done on diabetic mice found that hydrogen water reduced fatty lever and obesity and decreased insulin, glucose and triglyceride levels by stimulating metabolic energy. Yet another rat study, showed the water was able to prevent hardening of the arteries.

A study on patients with metabolic syndrome who drank 1.5 to 2L of hydrogen water daily for 8 weeks, showed the water led to an increase in HDL (good) cholesterol and a decrease in cholesterol overall.

What do you think? Is hydrogen water worth investigating? Let us know if you’ve tried it, and what you think.

Bullet Points For Increased Life Expectancy

The secret to longevity has baffled people for years. There are nonagenarians who swear by their cigars, and centenarians who swear cigars off like the plague. There are octogenarians who ski every day and skiers who fracture their hips on a tough trail. There are healthy eaters who live long, and then there are the French who drink red wine and red meat and remain hale and hearty as horses. If anything is clear about the secret to longevity, its that it is unclear, however, that’s not going to stop anyone from trying to find it. If you’re among those making an effort to do so, scientists may have a few clues to point you in the right direction. Here are a few of the things that research has discovered about longevity.

Your Personality Plays A Role
The Longevity Project is a eight decade spanning study dedicated to the baffling secret of long life. During that time, Stanford researchers Leslie R. Martin and Howard S. Friedman have discovered a few things about personality’s effects on life expectancy. According to them, “The qualities of a prudent, persistent, well organized person, like a scientist professor – somewhat obsessive and not at all carefree” are more likely to be present in a person who reaches old age. “Many of us assume that more relaxed people live longer, but that’s not necessarily the case.” Apparently conscientious people are more likelier to make healthier choices about work, marriage, and daily habits..

Your Diet Comes Into Play
When it comes to diet, it seems that those who reside in the Mediterranean, and follow the diet of the area, are the most likely to make it into their twilight years. The diet, which consists largely of vegetables, nuts, fruits, and olive oil has been linked to lower risk for heart disease and even protection from memory loss.

Genetics
It may come as no surprise that your parents’ life spans may give you an idea about what yours is likely to be. The autopsy of a 115- year- old woman revealed stem cell exhaustion as a reason for death. This means the woman remained healthy until her cells literally gave out. Other research shows that some people are less prone to diseases or have levels of chemicals, like dopamine and seratonin in the brain that may attribute to superior bodily functions.

Education
If you find yourself with an extra four years at the end, those may be the years you spent in college. A 2012 report from the CDC’s National Center for Health Statistics found that those with bachelor’s degrees or higher, can live about nine years longer than those who didn’t finish high school. According to health economist, James Smith, educated people make better plans for their future, get better jobs, and make healthier lifestyle choices.

Work Stress May Not Be A Factor
If you think “your job is killing you,” it may not be. According to the Longevity Study, long lives and hard work are not mutually exclusive. The authors say, “We found that productive, hardworking people are not stressed and miserable, but tend to be happier, healthier, and more socially connected than their less productive peers.”

Do you have any clues for us about the path to longevity? We’re dying to hear them.

woman with vitiligo

Vitiligo May Soon See New Treatment Options

Even in these days of positive body imaging, conditions such as vitiglio remain a challenge. While many women have come out in the shared desire to be appreciated despite weight issues, there is not such a platform for those with skin pigmentation conditions, which tend to be less common and less publicized. Sufferers of vitiglio often struggle with low self esteem, and are often the objects of unwanted attention in public places. Building awareness and acceptance about such condition is important, as is trying to find new treatment approaches. Here are some new thoughts and insights into the genetic disorder.

Genetic Predisposition
With new research comes new hope. Pearl E Grimes, MD and director of Vitiglio Pigmentation Institute of Southern California says that with the advancement of genetic research in the past ten years, “We now know that probably 90% of the genes the have been identified in vitiglio are immune-susceptibility genes, 10% are pigment related genes.” Because the condition is so often genetic, it can lead to “sick melanocytes.” This means, “Melanocytes from people with vitiglio do not grow as well in culture. There are probably some inherent defects in these melanocytes that may tie back to the genetics of the disease.”

Oxidative Stress
Another finding of the latest research points to oxidative stress as the event that starts off the immune dysfunction that culminates in vitiglio. Grimes says, “In vitiglio, we know that hydrogen peroxide is up, while catlase – a major oxidative stress fighting molecule is down.” The lack of the body’s ability to protect against oxidation may be what leads to the release of the antigens that play a role in destroying the melanocytes that lead to vitiglio.”

Raising Awareness
Dr Grimes relates a story of a beautiful 40 -year- old patient whose face caused a toddler to cry. “In response to that incident,” the patient said, “I don’t go out. I don’t date anymore, I have isolated myself, and I feel ugly.”

Grimes explains that vitiglio patients require a very long initial consolation. She says, “We take a very detailed history-looking at family history, a time of disease onset, disease progression, associated symptoms, associated autoimmune illnesses, and medications to tease out any other causative factors that may be contributing to pigment loss.”

Besides uncovering the physical causes, Dr. Grimes also stresses addressing the psychological impact of the condition. She steers aways from direct, overly probing questions, saying, “I go about it in a subdued, roundabout way -trying to let them talk about it first. I want them to be comfortable.” Instead of asking about the impact of the disease on the patient’s quality, she prefers to inquire about changes in daily routines. “Some will say, ‘I wear makeup all the time, even on my hands.'”

After performing a complete physical exam with photos and a laboratory assessment, Grimes reports that she is, “able to put together a treatment regimen based on the patient’s symptoms.” She is also able to assemble a health care team is needed, including a rheumatologist, immunologist, and mental health professional.

What can you do to raise awareness about vitiglio? Are these findings promising? Let us know what you think.

Can Exercise Help Improve Hypersomnia?

Hypersomnia: A condition causing excessive daytime drowsiness. Aerobic exercise: an activity requiring excessive daytime energy. The two would seem to be in direct contrast to one another, but could one be the cure for the other? While it may seem vigorous exercise would be the last thing on a drowsy person’s to do list, new studies show that exercise may be a way to alleviate the symptoms of hypersomnia in depressed individuals. Could there be a science behind this theory? Let’s take a look.

Symptoms of Hypersomnia
Individuals with hypersomnia are likely to doze off regularly and repeatedly during the day, often at inappropriate times, including during meals, at work, or in conversation. They may show difficulty waking from a long sleep and feel disoriented upon waking. Anxiety, decreased energy, slowness of thought and speech, memory lapses, loss of appetite, and increased irritation are also among the symptoms of the condition. In severe cases, patients may lose their ability to function in social, family, and occupational settings.

Demographics
Hypersomnia is a rather uncommon disorder affecting a very small percentage of the population. Only 5% or fewer adults complain about feeling excessively sleepy during the day, and of that 5% only 5-10% are diagnosed with hypersomnia. It generally appears in a patient between the ages of 15 and 30, and tends to happen gradually, sometimes taking years to develop fully.

woman exercising indoors

The Research
Researchers at UT Southwestern Medical Center’s Center for Depression Research and Clinical Care are the group behind the findings about the positive effect of aerobic exercise upon the depressive condition. These researchers found that exercise lowered the levels of two biological markers for hypersomnia in blood samples, reducing the likelihood of excess sleepiness.

According to senior study author, Madukar Trivedi, MD, “Hypersomnia, as well as insomnia have been linked in the development, treatment, and recurrence of depression. Identifying these biomarkers, combined with new understanding of the important role of exercise in reducing hyperemia, have potential implications in the treatment of major depressive disorder.”

Previous research had found a negative loop in which sleep, depression, and inflammation interact, with detrimental results. The current findings suggest that exercise may be the key to resetting the loop. Researchers identified biomarkers based on the blood samples of 100 participants who were asked to perform two kinds of aerobic excersises. The subjects consisted of people ages 18 to 70 who all suffered from major depression disorder.

After a 12 week period,researchers had located reductions in tow biomarkers related to hypersomnia. Lead author Chad Rethorst, PhD says, “Identification of biomarkers that uniquely predict or correlate with improvement in hypersomnia and insomnia is an important step toward more effective treatment of MDD.

Do you suffer from hypersomnia or know someone who does? Let us know what you think of the new findings.

What Are DHEA Supplements?

You see them on news programs. The octogenarian, nonagenarians, and even centenarians, those lucky people who seem to be age defiant, surviving years of life, still remaining active, cognizant and even rather attractive. Inevitably, these people are asked how they do it; what is the secret to the fountain of youth, and inevitably some saucy senior will reply by saying they credit regular sex with their youthful appearance. True, we do often associate higher sex drive with youthfulness, but is it possible that the opposite is true? Is there anything substantial behind the idea that increased sex drive can lead to a more healthy, longer life? Read on to find out about the possible benefits of DHEA supplements.

What is DHEA?
Dehydroepiandrosterone (DHEA) is a hormone found naturally in your body, manufactured by the adrenal glands. There, it is converted into male and female sex hormones, like estrogen and testosterone. Recent studies suggest that taking DHEA in the form of a supplement can boost levels of estrogen and testosterone, protecting the body from health problems stemming from hormonal imbalance or age related decline in hormonal levels.

How Can It Help?
Studies Show some degrees of success in DHEA supplementation in the following areas:

Depression
Research supports the possibility of a link between depression and DHEA levels. According to recent research reports, DHEA supplements may be useful in the treatment of major depression. However, further studies need to be done before any affirmative conclusions can be reached.

Bone Density
The aging process and diseases such as anorexia and lupus, have all been associated with bone loss. There is some evidence to suggest that higher DHEA levels may be associated with higher bone density, specifically in post menopausal women and that DHEA supplements may have the ability to increase of bone density.

Weight Loss
Could DHEA be the key to shedding those extra pounds? Studies show that 7-KETO, a DHEA containing product may help stimulate metabolism and assist in weight loss. Again, more long term research still remains to be done.

Adrenal Insufficiency
Adrenal Insufficiently is a condition in which adrenal glands do not produce enough hormones. Recent studies show that DHEA supplements may improve hormone levels, and quality of life for people with the condition. However, other research found that DHEA had little effect of symptoms of depression, and heart health.

Sexual Function
Here’s where you’d think it would make perfect sense. Because research has shown a link between lower levels of DHEA in man and erectile dysfunction, it would seem to be a no brainer that DHEA supplements can boost low libido. However, higher quality studies reveal inconsistent results in the effect of DHEA on libido, sexual performance and erectile dysfunction. Although research looks promising, additional studies are required.

Lupus
Lupus is an autoimmune disorder which affects the organs and skin. Women suffering from this condition also exhibit lower levels of DHEA, hence,the suggestion that DHEA may improve immune function. While some trials report a lack of effect of DHEA treatment on lupus activity, there is evidence that it can be effective when used regularly.

What do you think of the use of DHEA supplements to improve health? Have you tried them? Let us know about your DHEA experiences.

woman holding oil bottle

The Oils Of Longevity

You may have heard people saying they can’t live without their morning coffee, but we usually don’t take them literally. Just when you thought your caffeinated cup had reached the limit in positive attributes, there comes proof that having a cup of coffee each day may be just what you need to keep having more days to have more cups of coffee! And while you’re at it, you may want to pop some fish oil pills too; they apparently have similar effect.

Recent studies show that both coffee and fish oil contain properties which can actually promote longevity. Not convinced? Here’s a look at some of the latest research on drinking coffee and taking fish oil capsules and why it may just be the latest recipe for long life.

What Are Telomeres?
You may have heard of these little caps at the end of our DNA. Telomeres control our lifespan by determining how many times our cells divide and stay alive. As we get older, environmental stressors take their toll, and these telomeres get shorter, meaning our lives do as well. Therefore, keeping them long is key to longevity. The latest way to do that is by drinking your morning coffee with a side of fish oil.

Fish Oil and Longevity
A study in the 2016 issue of Nutrients looked at the effect of omega-3 fatty acids from fish oil on tele mere length in a controlled trial. Experts attribute the increase in length to a reduction of oxidative stress.

An additional study in Brain, Behavior, and Immunity seems to support these findings. The study included 106 individuals with an average age of 51 who were considered relatively healthy, divided into three groups. One group received 2.5 grams of long chain omega-3’s per day, a second received 1.25 grams a day, and one received placebo pills that had proportion of fatty acids similar to those found in an average American diet. After four months, results showed a significant increase in telomere length and a decrease in oxidative stress among those who received the omega-3 supplements.

The two main types of long chain omega-3 fats are most often found in fish such as sardines, herring, salmon, and mackerel. Alpha-linolenic acid is a short chain omega-3 fatty acid that can be found in flaxseeds and walnuts.

Coffee and Longevity
Coffee is already a well known source of antioxidants which makes it a life lengthening beverage. Scientists ar the Journal of Nutrition used data from the Nurse’s Health Study form 1976 to explain the link between coffee drinking and telomere length in 4780 female nurses, and found a direct correlations. Of the nurses, those who drank 2 cups of coffee daily had a 29% higher chance of having an average telomere lengthen while the odds were 36% higher in those who drank 3 cups.

However experts are quick to point out that while coffee may be very beneficial to your health, caffeine may not. Although researchers from the University of Scranton say coffee is America’s number one antioxidant source, they are also quick to remind us that regular and decaf have the same antioxidant levels, and too much caffeine can cause unwanted side effects. Try to keep caffeine consumption at a moderate 300-400mg daily, about 3 to 4 cups of coffee to keep away anxiety and depression.

What do you think? Is fish oil and coffee the new Breakfast of Champions? Let us know!

woman on sofa biting her nails

Try These Gadgets For Folks Who Fidget

Are you a leg bouncer? Knuckle cracker? Nail biter? Pen tapper? Hair twirler? Paper shredder? Nose picker? Just an all around fidgeter? Surely, it seems like a victimless crime, if it is a crime at all. A study done in England says the habit can make it easier for children to concentrate, providing an outlet for excess energy, allowing students to better focus on their work. Others disagree, claiming that the mere multitasking elements can only provide a distraction from learning. Either way, you can safely say that manufacturers will seldom miss an opportunity to capitalize on a human habit. Here are some fidget friendly gadgets for the fidgeters in your life.

Squigz
Otherwise known as fat brain toys, these may be the next thing for those who can’t put down the bubble wrap. These suction cupped beauties can stick to any flat surface, and even each other, and best of all, they pull a part with a satisfying pop.

Mashems
These squishy critters, shaped like popular character can be stuck to flat surfaces or squeezed to watch them balloon up in your hand. Look for them in the likeness of Marvel or DC characters, Paw Patrol, and My Little Pony.

man playing with rubik's cube

Anastasiia Moiseieva / Shutterstock.com

Rubik’s Cube
One of the original, if not the original, the Rubik’s Cube has been a fidget fixture for decades. While mixing up the various colors may not seem too perplexing, matching them back is quite another story.

Swingy Thing
This portable desk toy features several pendulums that can swing around, providing over 52 spinning challenges for different color combinations.

Madballs
They’re back! You were fidgeting with them in the 1980’s and you’re fidgeting with them now. These mummies, monster, werewolves, zombies perfect for bouncing and squeezing are making a mad comeback in the fidgety millennium.

Slinky
How could we forget the commercials with the kids watching their slinks climbing down the stairs. Plastic, or metallic, you can still enjoy the calming effect of bouncing it on your palms. Good luck getting it down the whole flight!

woman holding fidget spinner

Fidget Spinners
Unless you have been hiding under a rock for the last month or so, it is highly unlikely that you have missed the fidget spinner. The tri- shaped toys feature ball bearing that spin around the center when you flick them. Available in all sorts of irresistible colors and patterns, these are a great way to keep your hands occupied, providing hours of fidgeting fun.

Thumb chucks
The name alone sounds intriguing. Thumb chucks actually can help provide exercise for the fingers. The ingenious invention consists of two small rubber balls connected by a strap. The object is to flick your fingers and wrist to send the balls swinging, and rolling over your hand for awe inducing hours of fun. The LED lights in the balls light up on impact with any surface, so prepare for fireworks.

Morph
Give this squishy compound a try for morphing fun that never dries out and gets softer as you play with it. Squeeze it, mold it, stretch it or bounce it, this no mess toy is a fidgeter’s dream.

Tangle Therapy
If you enjoy getting knots out of jewelry, this one may be for you. Composed of elbow pieces covered in texturized rubbers, this twistable tool can be snapped, bent, and squeezed for a unique tactile experience.

What do you think of fidgeting? Harmless fun or major distraction. Let us know how you weigh in on this latest sensation.

Marine Snail Venom Can Prevent Pain and Opioid Addiction

If you have gone to any of the summer music festivals, you may have noticed that people with altered perceptions seem to like looking at snails. It seems that snails shells, being spiral in nature, are actually symbolic of an expanding consciousness, looking inward to seek answers, while the antennae represent exploration, which may explain the river fascination. In short, the entire body of a snail is considered a sensory tool capable of experiencing reality through uncommon sensory perception. Perhaps then, it shouldn’t be too much of a stretch to consider that these creatures may actually be capable of sensory alteration, specifically, pain relief and there may be scientific proof to back it up. Read on to discover how snail venom may be an alternative to addictive opioid drugs.

Snail Venom As An Opioid Replacement
Snail venom may be the latest answer to pain. According to recent research, the venom of the small cone snail, commonly found in the Caribbean sea, may contain compounds which act on pain pathways in the body, thus providing an alternative to pain-relieving opioids.

According to psychologist Michael McIntosh, who is involved in the research, transmissions that sense pain normally travels up through the back part of the spinal chord. However, the types of sensations we feel, such as heat, cold, pain, and itch can come from other receptors. The pain pathways that opioids target are very specific. However, McIntosh and his team have discovered that snail venom can affect alternate pathways, providing for more long term relief.

McIntosh allows that opioids can be great for acute, short-term pain, but snail venom can provide long lasting relief for chronic pain, commonly caused by injury to a nerve. Says McIntosh, “What these compounds from the snail do is they not only provide relief in the short run, they seem to provide long lasting relief and they seem to do so b y actually preventing some of the pathophysiologies that occur after a nerve injury.”

boy examines snail on a leaf

Indications
McIntosh explains that each type of venom-bearing species has a unique component in their venom, designed to capture prey and work on the nervous system, and is therefore often used in the study of relieving nerve pain.

The study proved two things. First that the compound from cone snail venom can be turned into a compound that may be useful to humans, and secondly that it could be used as a specific called chemotherapy-induced neuropathic pain. McIntosh explains, “What we found, in this case, was that we could give the chemotherapy agent and our compound that we developed and prevent the nerve damage that normally occurs after chemotherapy.”

What’s Next?
Now the medical field must focus on bringing the snail venom into practical use. Says McIntosh, “The next step is to conduct additional preclinical trials with the aim of applying to the Food and Drug Administration for investigational new drug status so that human clinical trials can begin.” He adds that the venom may also prove to be useful for the relief of pain for diabetics and others suffering from chronic pain caused by injury to a nerve, surgery, lower back pain, or a car accident.
“We want to get at the root of the problem, not just mask the symptoms,” he says.

What do you think about snail venom as an alternative to opioid drugs? Let us know.

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.

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