Your Guide to Reporting Problems to FDA

This Consumer Update video explains the importance of reporting problems to FDA, and provides guidance on what and how to report. Learn more at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm

Source:FDA

Kids 'n Fiber

Getting kids to eat the fiber they need can be a challenge. Join FDA dietitian, nutritionist, and mom Shirley Blakely and a group of hungry Kids in a kitchen for some good-tasting high fiber foods.
For more about fiber go to: www.fda.gov/ForConsumers/ConsumerUpdates/ucm270899.htm

Source: FDA

Agent reduces autism-like behaviors in mice Boosts sociability, quells repetitiveness — NIH study

 

National Institutes of Health researchers have reversed behaviors in mice resembling two of the three core symptoms of autism spectrum disorders (ASD). An experimental compound, called GRN-529, increased social interactions and lessened repetitive self-grooming behavior in a strain of mice that normally display such autism-like behaviors, the researchers say.

GRN-529 is a member of a class of agents that inhibit activity of a subtype of receptor protein on brain cells for the chemical messenger glutamate, which are being tested in patients with an autism-related syndrome. Although mouse brain findings often don't translate to humans, the fact that these compounds are already in clinical trials for an overlapping condition strengthens the case for relevance, according to the researchers.

"Our findings suggest a strategy for developing a single treatment that could target multiple diagnostic symptoms," explained Jacqueline Crawley, Ph.D., of the NIH’s National Institute of Mental Health (NIMH). "Many cases of autism are caused by mutations in genes that control an ongoing process — the formation and maturation of synapses, the connections between neurons. If defects in these connections are not hard-wired, the core symptoms of autism may be treatable with medications."

Mouse pays a social visit to a novel animal. Source: MuYang, Ph.D., and Jacqueline Crawley, Ph.D., NIMH Laboratory of Behavioral Neuroscience

Crawley, Jill Silverman, Ph.D., and colleagues at NIMH and Pfizer Worldwide Research and Development, Groton, CT, report on their discovery April 25th, 2012 in the journal Science Translational Medicine.

"These new results in mice support NIMH-funded research in humans to create treatments for the core symptoms of autism," said NIMH director Thomas R. Insel, M.D. "While autism has been often considered only as a disability in need of rehabilitation, we can now address autism as a disorder responding to biomedical treatments."

Crawley's team followed-up on clues from earlier findings hinting that inhibitors of the receptor, called mGluR5, might reduce ASD symptoms. This class of agents — compounds similar to GRN-529, used in the mouse study — are in clinical trials for patients with the most common form of inherited intellectual and developmental disabilities, Fragile X syndrome, about one third of whom also meet criteria for ASDs.

To test their hunch, the researchers examined effects of GRN-529 in a naturally occurring inbred strain of mice that normally display autism-relevant behaviors. Like children with ASDs, these BTBR mice interact and communicate relatively less with each other and engage in repetitive behaviors — most typically, spending an inordinate amount of time grooming themselves.

An untreated BTBR mouse absorbed in repetitive self-grooming. Source: MuYang, Ph.D., Adam Katz, and Jacqueline Crawley, Ph.D., NIMH Laboratory of Behavioral Neuroscience

Crawley's team found that BTBR mice injected with GRN-529 showed reduced levels of repetitive self-grooming and spent more time around — and sniffing nose-to-nose with — a strange mouse.

Moreover, GRN-529 almost completely stopped repetitive jumping in another strain of mice.

"These inbred strains of mice are similar, behaviorally, to individuals with autism for whom the responsible genetic factors are unknown, which accounts for about three fourths of people with the disorders," noted Crawley. "Given the high costs — monetary and emotional — to families, schools, and health care systems, we are hopeful that this line of studies may help meet the need for medications that treat core symptoms."

The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit the www.nimh.nih.gov.

Source: NIH

AEDs: Keeping Hearts Beating

 

Automatic External Defibrillators (or AEDs) are life-saving medical devices that can detect certain abnormalities in the way a person's heart is beating, and deliver electrical shocks to the heart to restore a normal heart beat. These devices are used in emergencies by physicians, nurses, emergency responders, and even bystanders on patients who have collapsed due to sudden cardiac arrest. At FDA, electrophysiologists, software engineers and other scientists help ensure that AEDs are safe and effective. For more on automatic external defibrillators and other medical devices, visit http://www.fda.gov/medicaldevices

Source: USFoodandDrugAdmin

Cochlear Implants for Hearing

Cochlear implants are electronic devices that can give people with severe nerve deafness the sensation of hearing. They usually include a microphone, a sound processor and a transmitter outside the body, and electronic circuits implanted inside the body, which send electrical currents to the inner ear. At FDA, electrical engineers, electrochemists, neurologists, infection control experts and material scientists work together to help make sure cochlear implants are safe and effective. For more on cochlear implants and other medical devices, visit http://www.fda.gov/medicaldevices

Source: USFoodandDrugAdmin

From Molecule to Medicine

NORVELL JEFFERSON, a Belgian audiovisual production company, is awarded with two GOLD medals for the short film 'From Molecule to Medicine' at the New York Festivals' International Film & Video Awards 2008. The film is selected as 'World's best work 2007' in two categories: 'Health/Medical Issues' and 'Health Care Professional Education'. The 6 minute film explains the various stages for a pharmaceutical company to develop new medical cures. With state-of-the-art 3D animations and beautifully shot High Definition images the film unravels the secrets of how our body works. It clearly shows what processes occur in conditions of sickness and how scientists use their knowledge to discover new, innovative drugs to help patients worldwide.
www.norvelljefferson.com

Clues to Emerging Drug-Resistant Malaria

 

Researchers report that a first-line treatment for malaria is losing its effectiveness in parts of Asia. They've also found regions of the parasite’s genome that seem to underlie its drug resistance. The findings may offer clues to help block the spread of hard-to-treat malaria.

Child in a poor village in Thailand, where artemisinin-resistant malaria has begun to emerge. Photo by N. Durrell McKenna, Wellcome Images. All rights reserved by Wellcome Images.

Each year malaria kills more than a half million people and infects over 200 million worldwide, mostly in tropical regions. Drug combinations containing artemisinin, introduced more than a decade ago, have helped to reduce malaria death and disease. But health officials have been alarmed by emerging strains of artemisinin-resistant parasites found in Cambodia. Scattered but unconfirmed reports also describe artemisinin resistance in nearby countries such as Thailand and Myanmar (Burma). International efforts are under way to contain these drug-resistant strains.

To take a closer look at the evolution and spread of artemisinin-resistant malaria, an international team of scientists conducted 2 related studies. They drew on data collected from over 3,000 patients hospitalized in malaria clinics in northern Thailand between 2001 and 2010. Most of the patients came from the adjacent country of Myanmar. All the patients received artemisinin-based therapy. The research was funded in part by the Wellcome Trust and NIH’s National Institute of Allergy and Infectious Diseases (NIAID), along with other NIH components.

The researchers examined whether artemisinin resistance had indeed emerged along the Thailand-Myanmar border. As reported in the advance online edition of the Lancet on April 5, 2012, they measured how quickly treated patients cleared malaria parasites from their blood. Slower clearance indicates drug resistance.

The scientists found that the proportion of slow-clearing infections rose from 0.6% in 2001 to 20% in 2010. In 2001, it took patients an average of 2.6 hours to clear half of the parasites from their blood. By 2010, the average half-life clearance time had lengthened to 3.7 hours. The researchers tested a battery of genetic variations in the parasites and found 148 unique parasite genotypes, each infecting from 2 to 13 patients. Those infected with the same genotypes had similar clearance rates, suggesting that genetic variants play an important role in determining artemisinin resistance.

The other study compared parasites from the adjacent countries of Cambodia, Thailand and Laos. Artemisinin resistance is most common in Cambodia, apparently emerging in Thailand and absent from Laos. The findings were reported in the April 6, 2012, issue of Science.

The researchers identified 33 genome regions that differed greatly in parasites from the 3 countries. They then took a more detailed look at these regions in more than 700 parasites derived from the malaria patients treated in Thailand. The analysis found a small region of chromosome 13 that was strongly linked to slower artemisinin clearance rates. This discovery will help to narrow the search for genes that lead to artemisinin resistance.

“If we can identify the genetic determinants of artemisinin resistance, we should be able to confirm potential cases of resistance more rapidly,” says study leader Dr. Timothy Anderson of the Texas Biomedical Research Institute. “This could be critically important for limiting further spread of resistance.”

—by Vicki Contie

Source: NIH

Genetics of Bone Density

 

A new study linked 32 novel genetic regions to bone mineral density. The findings may help researchers understand why some people are more susceptible to bone fractures. The research also points to potential drug targets for preventing or treating osteoporosis.

Bones are made of a mineral and protein scaffold filled with bone cells. Bone is continually broken down and replaced. When the rate of bone loss outpaces the rate of replacement, bones weaken, eventually leading to osteoporosis and increased risk of fracture. More than 40 million people nationwide either have osteoporosis or are at increased risk for broken bones because of low bone mineral density (osteopenia).

Past studies suggest that genetic differences may account for more than half the variance in bone mineral density between people. Previous genome-wide association studies identified 24 genetic regions that influence bone mineral density. However, these genetic variants explained a small fraction of the variation in bone density, and none were shown to influence the risk of fracture in a definitive way.

A worldwide consortium with multiple research groups set out to do the largest search to date for variants related to bone mineral density. The effort was funded by many sources, including the European Commission and several NIH components, such as the National Institute on Aging (NIA) and National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS). The extensive research team—led by a group at Erasmus Medical Center in Rotterdam, the Netherlands—also included scientists at NIA. The study appeared online in Nature Genetics on April 15, 2012.

The researchers first combined data from 17 different studies involving more than 80,000 people across North America, Europe, East Asia and Australia. They looked across the genome for genetic variants associated with bone mineral density of the femoral neck and lumbar spine. The researchers found 96 independent variations from 87 genomic regions.

The scientists next tested these associations in over 50,000 more people from 34 other studies. They confirmed the association with bone mineral density in 56 regions, 32 of which hadn't been previously been tied to bone density.

The team also examined whether the 96 variants were associated with bone fractures. They analyzed data from 50 studies with fracture information. Combined, the studies involved over 31,000 people with fractures and over 102,000 controls. Fourteen of the regions, the researchers found, were also associated with bone fracture risk.

These findings reinforce the relationship between genetic factors and the risk of osteoporosis and bone fracture. However, the researchers found that the ability to use these factors to predict risk was modest relative to clinical risk factors such as age and weight.

“In reality, there may be 500 or more gene variants regulating osteoporosis,” says Dr. John Ioannidis of the Stanford University School of Medicine, one of the senior authors. “Each variant conveys a small quantum of risk or benefit. We can't predict exactly who will or won't get a fracture.”

“The ultimate goal of genetic studies like this is to develop personal, gene-based treatments for osteoporosis as well as to better identify those at high risk for the disease,” says another of the senior authors, Dr. Douglas P. Kiel of Harvard Medical School. “The findings could lead to new therapies to prevent or treat osteoporosis.”

—by Harrison Wein, Ph.D.

Source: NIH

Scale up the fight against malaria -- Test. Treat. Track.

During the past decade, global malaria prevention and control efforts
have been scaled up, with notable progress in sub-Saharan Africa. However, malaria transmission still occurs in 99 countries around the world. In 2010, this entirely preventable and treatable disease caused an estimated 655,000 deaths worldwide. About 560,000 of the victims were children under five years of age. On the occasion of World Malaria Day, 25 April 2012, the World Health Organization launches a
new initiative to urge countries and donors to reinforce the malaria fight.
For more information: http://www.who.int/malaria

Source:who

Message by Dr Ala Alwan for World Immunization Week 2012

A message by WHO Regional Director for the Eastern Mediterranean, Dr Ala Alwan, to mark World Immunization Week 2012.

For more information:
http://www.emro.who.int
http://www.who.int/immunization/immunization_week/en
http://www.who.int/immunization/immunization_week/ar

Source: who

WHO: Immunization saves lives (World Immunization Week 2012)

Immunization saves between 2 and 3 million lives each year. Vaccines are relatively inexpensive and extremely powerful weapons against disease, disability and death. They protect people of all ages, from babies to senior citizens, against life-threatening diseases. For the first time ever, from 21-28 April, countries across the world are participating in a World Immunization Week sponsored by the World Health Organization, to raise awareness on how immunization saves lives and to make sure that the poorest and hardest to reach communities get the vaccinations they need to protect their health. Follow us on Twitter @WHO http://twitter.com/#!/who #vaccineswork ... and share this video."Published on Apr 17, 2012 by who

Spontaneous Mutations Raise Autism Risk

 

A trio of new studies has revealed several genes and biological pathways that may contribute to autism spectrum disorders (ASD). Among other insights, the findings may help explain earlier evidence linking autism risk to older fathers.

ASD includes several related brain disorders, with symptoms ranging from mild to severe. People with ASD generally have trouble with social interactions and communication. Over the past few years, large research efforts have linked many rare mutations with ASD. But for at least 70% of ASD cases, there are still no known underlying genetic causes.

Three separate research teams set out to examine de novo DNA variations, which are found in a child's DNA but not in either parent's. These spontaneous mutations arise during the creation of germ cells (egg or sperm). While less frequent than the types of genetic variations that past studies have examined, they can be very harmful. The scientists believed these variations might offer new insights into ASD risk.

All 3 teams focused on exomes—the complete set of protein-coding regions in the genome. The exome represents only about 1.5% of the genome but harbors most disease-causing mutations. The researchers sequenced the exomes of affected children and their parents. One team also compared healthy siblings. In all, the scientists drew upon samples from 549 families. Two of the teams received substantial NIH funding, and all are members of the Autism Sequencing Consortium, which NIH helped to develop. The reports appeared together in the early online edition ofNature on April 4, 2012.

The studies showed that, while a single de novo mutation is unlikely to fully explain disease in a given patient, sporadic mutations widely distributed across the genome can raise the risk for ASD. Many of the genes implicated in the new studies were previously tied to ASD, but some weren't. The genes tend to be related. Many are involved in fundamental developmental pathways, particularly in the brain.

Notably, one of the studies found an explanation for the previous discovery that fathers of children with autism were much more likely to be older. Fathers turned out to be 4 times more likely than mothers to transmit de novo mutations that increase ASD risk to their children—and the number of these mutations increased with the father's age. This can be explained by the higher turnover in sperm cells. Each time DNA is copied, there's a chance that errors will become part of an offspring's DNA makeup.

“These results confirm that it's not necessarily the size of a genetic anomaly that confers risk, but its location—specifically in biochemical pathways involved in brain development and neural connections. Ultimately, it's this kind of knowledge that will yield potential targets for new treatments,” says Dr. Thomas R. Insel, director of NIH's National Institute of Mental Health (NIMH).

“These studies begin to tell a more comprehensive story about the molecular underpinnings of autism that integrates previously disparate pieces of evidence,” says Dr. Thomas Lehner, chief of the NIMH Genomics Research Branch.

There are many forms of autism under the umbrella of ASD. Given the complexities, larger studies will be needed to fully understand the genetic events that affect ASD risk.

Breaking Bad Habits……………. Why It’s So Hard to Change

 

If you know something’s bad for you, why can’t you just stop? About 70% of smokers say they would like to quit. Drug and alcohol abusers struggle to give up addictions that hurt their bodies and tear apart families and friendships. And many of us have unhealthy excess weight that we could lose if only we would eat right and exercise more. So why don’t we do it?

NIH-funded scientists have been searching for answers. They’ve studied what happens in our brains as habits form. They’ve found clues to why bad habits, once established, are so difficult to kick. And they’re developing strategies to help us make the changes we’d like to make.

“Habits play an important role in our health,” says Dr. Nora Volkow, director of NIH’s National Institute on Drug Abuse. “Understanding the biology of how we develop routines that may be harmful to us, and how to break those routines and embrace new ones, could help us change our lifestyles and adopt healthier behaviors.”

Habits can arise through repetition. They are a normal part of life, and are often helpful. “We wake up every morning, shower, comb our hair or brush our teeth without being aware of it,” Volkow says. We can drive along familiar routes on mental auto-pilot without really thinking about the directions. “When behaviors become automatic, it gives us an advantage, because the brain does not have to use conscious thought to perform the activity,” Volkow says. This frees up our brains to focus on different things.

Habits can also develop when good or enjoyable events trigger the brain’s “reward” centers. This can set up potentially harmful routines, such as overeating, smoking, drug or alcohol abuse, gambling and even compulsive use of computers and social media.

“The general machinery by which we build both kinds of habits are the same, whether it’s a habit for overeating or a habit for getting to work without really thinking about the details,” says Dr. Russell Poldrack, a neurobiologist at the University of Texas at Austin. Both types of habits are based on the same types of brain mechanisms.

“But there’s one important difference,” Poldrack says. And this difference makes the pleasure-based habits so much harder to break. Enjoyable behaviors can prompt your brain to release a chemical called dopamine. “If you do something over and over, and dopamine is there when you’re doing it, that strengthens the habit even more. When you’re not doing those things, dopamine creates the craving to do it again,” Poldrack says. “This explains why some people crave drugs, even if the drug no longer makes them feel particularly good once they take it.”

In a sense, then, parts of our brains are working against us when we try to overcome bad habits. “These routines can become hardwired in our brains,” Volkow says. And the brain’s reward centers keep us craving the things we’re trying so hard to resist.

The good news is, humans are not simply creatures of habit. We have many more brain regions to help us do what’s best for our health.

“Humans are much better than any other animal at changing and orienting our behavior toward long-term goals, or long-term benefits,” says Dr. Roy Baumeister, a psychologist at Florida State University. His studies on decision-making and willpower have led him to conclude that “self-control is like a muscle. Once you’ve exerted some self-control, like a muscle it gets tired.”

After successfully resisting a temptation, Baumeister’s research shows, willpower can be temporarily drained, which can make it harder to stand firm the next time around. In recent years, though, he’s found evidence that regularly practicing different types of self-control—such as sitting up straight or keeping a food diary—can strengthen your resolve.

“We’ve found that you can improve your self-control by doing exercises over time,” Baumeister says. “Any regular act of self-control will gradually exercise your ‘muscle’ and make you stronger.”

Volkow notes that there’s no single effective way to break bad habits. “It’s not one size fits all,” she says.

One approach is to focus on becoming more aware of your unhealthy habits. Then develop strategies to counteract them. For example, habits can be linked in our minds to certain places and activities. You could develop a plan, say, to avoid walking down the hall where there’s a candy machine. Resolve to avoid going places where you’ve usually smoked. Stay away from friends and situations linked to problem drinking or drug use.

Another helpful technique is to visualize yourself in a tempting situation. “Mentally practice the good behavior over the bad,” Poldrack says. “If you’ll be at a party and want to eat vegetables instead of fattening foods, then mentally visualize yourself doing that. It’s not guaranteed to work, but it certainly can help.”

One way to kick bad habits is to actively replace unhealthy routines with new, healthy ones. Some people find they can replace a bad habit, even drug addiction, with another behavior, like exercising. “It doesn’t work for everyone,” Volkow says. “But certain groups of patients who have a history of serious addictions can engage in certain behaviors that are ritualistic and in a way compulsive—such as marathon running—and it helps them stay away from drugs. These alternative behaviors can counteract the urges to repeat a behavior to take a drug.”

Another thing that makes habits especially hard to break is that replacing a first-learned habit with a new one doesn’t erase the original behavior. Rather, both remain in your brain. But you can take steps to strengthen the new one and suppress the original one. In ongoing research, Poldrack and his colleagues are using brain imaging to study the differences between first-learned and later-learned behaviors. “We’d like to find a way to train people to improve their ability to maintain these behavioral changes,” Poldrack says.

Some NIH-funded research is exploring whether certain medications can help to disrupt hard-wired automatic behaviors in the brain and make it easier to form new memories and behaviors. Other scientific teams are searching for genes that might allow some people to easily form and others to readily suppress habits.

Bad habits may be hard to change, but it can be done. Enlist the help of friends, co-workers and family for some extra support.

Source:NIH

Making Your Resolutions… Stick How to Create Healthy Habits

 

New Year’s resolutions—they’re easy to make but easier to break. Why is it so hard to make the healthy changes that we know can help us feel better and live longer? And why is it so hard to make them last? NIH-funded scientists are learning more about how we can make healthy changes and, even more important, how we can sustain them.

“Change is always possible,” says Dr. Linda Nebeling, an expert in behavioral change and nutrition at NIH. You’re never too out-of-shape, too overweight or too old to make healthy changes.

Some of the most common New Year’s resolutions are losing weight, getting more physical activity, eating more nutritious foods, quitting cigarettes, cutting back on alcohol, reducing stress and sleeping better. But no matter which healthy resolution you choose, research suggests that some common strategies can boost your chance of making the change a habit, a part of your daily lifestyle.

“One challenge with New Year’s resolutions is that people often set unrealistic goals. They can quickly become frustrated and give up,” says Nebeling. “Any resolution to change needs to include small
goals that are definable and accompanied by a solid plan on how you’ll get to that goal.”

For instance, a resolution to lose 30 pounds may seem overwhelming. Instead, try setting smaller goals of losing 5 pounds a month for 6 months. Think baby steps rather than giant leaps.

Next, develop an action plan. You might decide to walk a half hour each day to burn calories. You might stop buying vending machine snacks. Or you might limit and keep track of your daily calories. “These are specific behaviors that could help you meet your larger goal of losing 30 pounds,” says Dr. Deborah Tate, an obesity and behavioral researcher at the University of North Carolina.

To make a long-lasting change in your life, prepare yourself for the challenges you might face. “Think about why you want to make the change. Is it important to you, or is it mostly influenced by others—like your doctor, your spouse or a friend?” says Tate. “Research suggests that if it’s something you really want for yourself, if it’s meaningful to you, you’re more likely to stick to it.” 

Think of exactly how the change will enhance your life. For instance, when you stop smoking, your risk plummets for cancer, heart disease, stroke and early death. Reducing stress might cut your risk for heart disease and help you fight off germs. Even small improvements in your physical activity, weight or nutrition may help reduce your risk for disease and lengthen your life. In one study, overweight or obese people who lost just 7% of their body weight slashed their risk for diabetes by nearly 60%. Keeping facts like this in mind can help you maintain your focus over the long haul.

Setting up a supportive environment is another step toward success. “Think about the physical support you’ll need, like the right equipment for exercise, appropriate clothing and the right kinds of foods to have at home,” says Dr. Christine Hunter, a behavioral researcher and clinical psychologist at NIH. Remove items that might trip up your efforts. If you’re quitting smoking, throw away your ashtrays and lighters. To improve your nutrition, put unhealthy but tempting foods on a hard-to-reach shelf, or get rid of them.

Social support is also key. Research shows that people’s health behaviors—like smoking or weight gain—tend to mirror those of their friends, family and spouses. “You can enlist friends and family to help you eat better, to go on walks with you, to remind you to stay on track,” says Tate. “Find things that are fun to do together, and you’ll be more likely to stick with it.”

“It helps when you’re connected to a group, where lifestyle change like weight loss is a joint goal,” says NIH’s Dr. Sanford Garfield, who heads a large study called the Diabetes Prevention Program. Participants who lost weight through dietary changes and physical activity reduced their chances of developing diabetes. Group counseling that emphasized effective diet, exercise and behavior modification were credited, in part, with participants’ success. “There’s a long history of group support leading to good results,” Garfield says.  “People learn from each other and reinforce each other in working toward their goals.”

While making a change is one thing, sticking to it is something else. “Maintaining a change requires continued commitment until the change becomes a part of your life, like brushing your teeth or washing your hair,” says Nebeling. “People who can maintain or engage in efforts to change their behavior, and do it for 6 to 8 weeks, are more likely to be able to support that effort longer term.”

Some researchers are studying people who’ve made lasting healthy changes. The ongoing National Weight Control Registry compiles information on more than 5,000 adults who’ve dropped at least 30 pounds and kept it off for a year or more. Although the way these people lost their weight varied, those who’ve maintained their weight loss tend to use similar strategies. Notably, many participants track their progress closely, often in a daily journal or diary. If the numbers rise, they have an early warning to adjust their behaviors.

“Self-monitoring or tracking seems to be critical for almost every sort of behavior change,” says Hunter. That includes jotting down the foods you eat, keeping an exercise diary or making a record of your sleeping patterns.

Monitoring yourself might feel like a burden, but it’s one of the best predictors of successful change. “Think about how you can make tracking more convenient, so it fits naturally into your life,” Hunter says. For some people, that might be a pad of paper in a purse or pocket; for others, a mobile app or a computer program.

Make sure to have a plan to get back on track if you start to slip. “If you feel that your motivation is waning, think back and remind yourself why the change was important to you in the first place,” says Tate. “Maybe you wanted to have more stamina, feel better, to be able to play with grandchildren. Recalling these personal reasons can encourage you to get back on track.”

Of course, you don’t need a new year to make healthy changes; you can make them any time of the year. But New Year’s is an opportunity to think about the improvements you’d like to make and then take concrete steps to achieve them. Set realistic goals, develop an action plan and set it in motion. Make your new year a healthy one.

Source:NIH

Love Your Heart…… Take Steps To Reduce Heart Risks

 

February is American Heart Month—a time to reflect on the sobering fact that heart disease remains the number one killer of both women and men in the United States. The good news is you have the power to protect and improve your heart health.

NIH and other government agencies have been working to advance our understanding of heart disease so that people can live longer, healthier lives. Research has found that you can lower your risk for heart disease simply by adopting sensible health habits.

To protect your heart, the first step is to learn your own personal risk factors for heart disease. Risk factors are conditions or habits that make you more likely to develop a disease. Risk factors can also increase the chances that an existing disease will get worse.

Certain risk factors—like getting older or having a family history of heart disease—can’t be changed. But you do have control over some important risk factors such as high blood cholesterol, high blood pressure, smoking, excess weight, diabetes and physical inactivity. Many people have more than one risk factor. To safeguard your heart, it’s best to lower or eliminate as many as you can because they tend to “gang up” and worsen each other’s effects.

A large NIH-supported study published last month underscores the importance of managing your risk factors. Scientists found that middle-aged adults with one or more elevated risk factors, such as high blood pressure, were much more likely to have a heart attack or other major heart-related event during their remaining lifetime than people with optimal levels of risk factors.

“For example, women with at least 2 major risk factors were 3 times as likely to die from cardiovasculardisease as women with none or 1 risk factor,” says Dr. Susan B. Shurin, acting director of NIH’s National Heart, Lung and Blood Institute. “You can and should make a difference in your heart health by understanding and addressing your personal risk.”

To tackle your heart risk factors, it helps to know your numbers. Ask your health care provider to measure your blood cholesterol and blood pressure. Then determine if your weight is in the healthy range.

The higher your cholesterol level, the greater your risk for heart disease or heart attack. High blood cholesterol itself doesn’t cause symptoms, so you can’t know if your cholesterol is too high unless you have it tested. Routine blood tests can show your overall cholesterol level and separate levels of LDL (“bad”) cholesterol, HDL (“good”) cholesterol and triglycerides. All of these blood measurements are linked to your heart health.

High blood pressure (hypertension) is another major risk factor for heart disease, as well as for stroke. High blood pressure is often called the “silent killer” because, like high cholesterol, it usually has no symptoms. Blood pressure is always reported as 2 numbers, and any numbers above 120/80 mmHg raise your risk of heart disease and stroke.

“Scientific evidence is strong that controlling high blood cholesterol and high blood pressure prevents cardiac events such as heart attacks,” says Dr. Michael Lauer, a heart disease specialist at NIH. 

Your weight is another important number to know. To find out if you need to lose weight to reduce your risk of heart disease, you’ll need to calculate your body mass index (BMI, a ratio of weight to height). This NIH web page can help: www.nhlbisupport.com/bmi/bmicalc.htm. A BMI between 25 and 29.9 means that you’re overweight, while a BMI of 30 or higher means obesity.

Next, take out a tape measure. A waist measurement of more than 35 inches for women and 40 inches for men raises the risk of heart disease and other serious health conditions. Fortunately, even a small weight loss (between 5% and 10% of your current weight) can help lower your risk.

NIH has many tools available to help you aim for a healthy weight, including physical activity tips and a menu planner. To learn more, visit http://healthyweight.nhlbi.nih.gov/.

A heart-healthy diet includes a variety of fruits, vegetables and whole grains, as well as lean meats, poultry, fish, beans and fat-free or low-fat dairy products. Try to avoid saturated fat, trans fat, cholesterol, sodium (salt) and added sugar.

NIH's Therapeutic Lifestyle Changes (TLC) and Dietary Approaches to Stop Hypertension (DASH) diets both promote healthy eating. U.S. News & World Report named TLC and DASH the top 2 overall diets for 2012.

Regular physical activity is another powerful way to reduce your risk of heart-related problems and enjoy a host of other health benefits. To make physical activity a pleasure rather than a chore, choose activities you enjoy. Take a brisk walk, play ball, lift light weights, dance or garden. Even taking the stairs instead of an elevator can make a difference.

“At least 2 and a half hours a week of moderate-intensity physical activity can lower your risk of heart disease, stroke, hypertension and diabetes—a winner on multiple counts,” says Dr. Diane Bild, a cardiovascular epidemiologist at NIH.

If you have diabetes, it’s important to keep your blood sugar, or glucose, under control. About two-thirds of people with diabetes die of heart or blood vessel disease. If you’re at risk for diabetes, modest changes in diet and level of physical activity can often prevent or delay its development.

If you happen to be a smoker, the best thing you can do for your heart is stop. People who smoke are up to 6 times more likely to suffer a heart attack than nonsmokers. The risk of heart attack increases with the number of cigarettes smoked each day.

The good news is that quitting smoking will immediately begin to reduce your risk, and the benefit in reduced risk will continue to increase over time. Just one year after you stop smoking, your risk will have dropped by more than half.

Beyond controlling your risk factors, you should be alert to certain symptoms and get checked by a doctor. Common signals that something‘s wrong with your heart include angina—pain in the chest, shoulders, arms, neck, jaw or back—as well as shortness of breath, irregular heartbeat or palpitations (arrhythmia)
and fatigue.

Be aware that the symptoms of a heart attack can vary from person to person. If you’ve already had a heart attack, your symptoms may not be the same if you have another one.

Finally, don’t forget that you can influence your loved ones’ heart health by setting an example. Do you have children, grandchildren or other young people who look up to you? If you follow a heart-healthy lifestyle, it’s more likely that they will, too.  Because heart disease begins in childhood, one of the best things you can do for those you love is to help children build strong bodies and healthy habits. 

The bottom line is, it’s never too late to take steps to protect your heart. It’s also never too early. Start today to keep your heart strong. Talk to your doctor about your risk and to create an action plan. Love your heart.

Source:NIH

Red, Itchy Rash? Get the Skinny on Dermatitis

 

You’ve probably had a rash at some point or another, whether from poison ivy or the chickenpox or something more unusual. Why does your skin break out in red blotches like that? More important, is there anything you can do about it?

We often think of the skin as a barrier—it keeps the insides of our bodies in, and it keeps the outside world out. But our skin is also filled with special cells of the immune system. These cells protect the skin and body against viruses, bacteria and other threats. Whenever these cells detect a suspicious substance, they begin a chain reaction in the skin that leads to inflammation. The medical name for this reaction is dermatitis. But it’s more commonly known as a rash.

There are many different types of dermatitis, and each has a distinct set of treatments. Sometimes the skin’s immune cells react to something that directly touches the skin. Other times, the immune system flares in the skin because of a whole-body infection or illness.

The symptoms of these different types of rashes often overlap. “Itching is a common symptom for all these problems,” says Dr. Stephen I. Katz, director of NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Many rashes are red, painful, and irritated. Some types of rash can also lead to blisters or patches of raw skin. While most rashes clear up fairly quickly, others are long lasting and need to be cared for over long periods of time.

Eczema, or atopic dermatitis, is a dry, red, itchy rash that affects up to 1 in 5 infants and young children. It often improves over time, although it can last into adulthood or start later in life. In this condition, the water-tight barrier between skin cells gets weak, which lets moisture out and other things in. That’s why people with atopic dermatitis have to moisturize their skin, and they’re more susceptible to skin infections.

Researchers have recently identified specific genes that are involved in maintaining the skin barrier. People with certain versions of these genes are more likely to get atopic dermatitis.

“The skin is the outermost sentinel for fighting off bacteria and noxious agents,” says Katz. “If the barrier is broken somehow, you can become more allergic to things.”

A skin allergy, or allergic contact dermatitis, produces a red, itchy rash that sometimes comes with small blisters or bumps. The rash arises when the skin comes in contact with an allergen, a usually harmless substance that the immune system attacks. Allergens trigger allergic reactions. Allergens can come from certain soaps, creams and even pets.

Your immune system might not react the first time you encounter an allergen. But over time, your immune system can become sensitive to the substance. As a result, your next contact may lead to inflammation and an allergic rash.

“The most common form of dermatitis that is seen anywhere is an allergic contact dermatitis to nickel,” says Katz. “Why? Because of ear piercing.” Many inexpensive earrings are made of nickel, and over time, wearing nickel earrings can cause an allergic reaction to the metal.

Other common causes of allergic dermatitis are poison oak and poison ivy. The stems and leaves of these plants produce a chemical that’s likely to cause allergies. If you touch one of them, wash your skin as soon as possible. The chemical can also remain in clothing for a long time, so it’s important to wash any clothes or shoes—or even pets—that come into contact with these plants.

Mild cases of allergic contact dermatitis usually disappear after a few days or weeks. But if the rash persists, is extremely uncomfortable or occurs on the face, it’s important to see a physician. A doctor can prescribe medications that will tone down the immune reaction in the skin. This eases swelling and itching and will protect your eyes and face.

The immune cells of the skin can also produce rashes when they react to invading germs—like bacteria, fungi and viruses. Bacterial and viral infections within your body can cause your skin to break out in spots as well. The chickenpox virus, for example, can cause itchy spots in children. Years later, in older adults, the same virus may reappear as shingles, bringing a painful rash and high fever. Vaccines can prevent several rash-causing diseases, including chickenpox, shingles and measles.

Certain drugs, including antibiotics like amoxicillin, may also cause itchy skin rashes. If you’re allergic to a drug, a rash can be the first sign of a serious reaction. As with other allergies, a reaction to a drug may not occur the first time you take it. It could show up after several uses. Not all drug rashes are due to an allergy, however. If you break out in itchy spots after starting a new drug prescription, contact your doctor right away.

While most rashes get better with time, some can last a lifetime. Psoriasis, a condition where skin cells build up into thick red patches, tends to run in families. “It’s a complex genetic disease, in that there’s not one gene that causes psoriasis but many,” says Katz. Even though none of these genes alone has a great effect on the disease, knowing which genes are involved can help researchers design potential new treatments. Other long-term diseases that can produce rashes include autoimmune diseases, such as lupus, and some forms of cancer.

If you notice an itchy or painful rash on your skin, think twice before going to the drugstore and getting some cream if you don’t know the cause. “The creams that you buy can produce problems that make your original problem even worse,” Katz says. Because rashes can be caused by many different things—bacteria, viruses, drugs, allergies, genetic disorders, and even light—it’s important to figure out what kind of dermatitis you have.

“If you have any significant rash, you should see a dermatologist,” says Katz. A dermatologist, or skin doctor, is specially trained to figure out what’s causing a rash and help you get the right treatment.

Your skin is your protection. It’s not just the covering that keeps your body in; it’s also your first line of defense against germs and chemicals. Take care of your skin so your skin can take care of you.

Source:NIH

Understanding Insulin Sensitivity and Diabetes

 

A new discovery helps explain how adipose tissue (fat) affects insulin sensitivity and results in type 2 diabetes. The finding may lead to new strategies for treating the disease.

Diabetes is a disorder in the way the body uses glucose, a sugar that serves as fuel for the body. When blood glucose levels rise, the pancreas normally makes the hormone insulin, which signals cells to take sugar from the blood. Fat cells store excess glucose in the form of lipids (fats). In the most common form of diabetes, type 2, cells lose their sensitivity to insulin.

About 80% of people with type 2 diabetes are overweight, but the connection between adipose tissue and insulin sensitivity has been difficult to decipher. A research team led by Drs. Barbara Kahn and Mark Herman of Harvard Medical School and Beth Israel Deaconess Medical Center set out to investigate. Their work was funded primarily by NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It appeared in the advance online edition of Nature on April 1, 2012.

The team began with 2 types of transgenic mice in which insulin resistance and obesity don't correlate. The mice have alterations in GLUT4, the protein primarily responsible for transporting glucose into muscle and fat cells in response to insulin. AG4OX mice overexpress GLUT4 in adipose tissue. They become obese, yet they're able to control blood glucose levels. AG4KO mice, in contrast, don't produce GLUT4 in adipose tissue. They have a normal body weight but develop insulin resistance and type 2 diabetes.

The researchers compared gene expression in adipose tissue from the 2 types of mice. Genes involved in making lipids were expressed at high levels in AG4OX mice but low levels in AG4KO mice. These genes are known to be controlled by certain master regulator genes, so the team examined expression of these genes. One called ChREBP was found to be 50% higher in AG4OX adipose tissue and 44% lower in AG4KO adipose tissue. This suggests that adipose tissue GLUT4 affects fatty acid synthesis and insulin sensitivity by regulating ChREBP.

But analysis of ChREBP expression in numerous mouse strains and people showed a more complicated releationship. While ChREBP expression usually correlates with GLUT4 levels, it doesn't always. A closer look revealed a new form of the ChREBP gene, ChREBP-β, that begins from a different DNA start site than the previously known one, ChREBP-α, and makes a more active form of the protein.

The researchers found that expression of ChREBP-β isn't induced directly by GLUT4 but by ChREBP-α. This means that increased glucose transport into fat cells activates ChREBP and leads it to produce another, more potent version of itself.

Mice fed a high-fat diet showed reduced adipose ChREBP-β expression, while ChREBP- αlevels remained unchanged. This suggests that ChREBP-β may play a role in insulin resistance. When the researchers examined obese people, they found that expression of ChREBP-β, but not ChREBP-α, in adipose tissue predicts insulin sensitivity.

"Two things were surprising—first, that a lone gene could shift the metabolism of the fat cell so dramatically and then, that turning on this master switch selectively in adipose tissue is beneficial to the whole body," says Kahn.

This research revealed a new molecular player in fat cell insulin sensitivity.ChREBP-β might one day prove to be a good drug target to help treat or prevent type 2 diabetes.

—by Harrison Wein, Ph.D.

Health Fraud Awareness

FDA urges consumers to be on guard against fraudulent products claiming to treat, prevent, or cure a wide variety of medical conditions, including the H1N1 flu virus. In this Consumer Update video, FDA health fraud expert Gary Coody demonstrates fraudulent products removed from the market, and provides advice on how to spot and avoid health fraud. Learn more at
http://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/default.htm

Uploaded by USFoodandDrugAdmin

Fortify Your Knowledge About Vitamins

Although most people get all the vitamins they need from the foods they eat, millions of people take supplemental vitamins as part of their health regimen. This FDA Consumer Update video provides facts about vitamins, including information on how they are regulated. Learn more at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm118079.htm

Uploaded by USFoodandDrugAdmin

Neglected Tropical Diseases PSA 2010

Neglected tropical diseases blight the lives of a billion people worldwide and threaten the health of millions more. These diseases cause extensive pain, suffering and often life long disability with costly economic and health consequences.

Uploaded by who

Healthy ageing -- adding life to years

For the first time in human history, the world will soon have more older people than children. The human race is ageing and we are unprepared. Unless we change the way we think and act about ageing, we will miss the opportunity to age in good health and to build a society where older people are respected and valued members of society. That is why this year the World Health Organization is dedicating it's birthday - on 7 April - World Health Day - to healthy ageing. Watch and share the official World Health Day 2012 video, and join the conversation on healthy ageing on Twitter #AddHealth2Life to be part of the change.

Uploaded by who

Certain Foods Linked to Long-term Weight Gain

 

Munching more unprocessed plant foods may help keep the middle-aged bulge away, a new study suggests. On the other hand, meat, french fries and sugar-sweetened drinks can help pack on the pounds. The findings suggest that the types of food you choose, not just calories, are important for avoiding age-related weight gain.

Weight gain results from an imbalance between how much energy you take in and how much you expend. Even small amounts of excess weight can increase your risk for disorders such as diabetes, cardiovascular disease, metabolic syndrome and cancer.

A research team at the Harvard School of Public Health, led by Dr. Dariush Mozaffarian and Dr. Frank Hu, sought to gain insights into the changes in people’s lifestyles that lead to gradual, long-term weight gain. Their work was partially funded by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart, Lung and Blood Institute (NHLBI) and National Cancer Institute (NCI).

The team followed the lifestyle and dietary habits of 3 large groups of health professionals, totaling over 120,000 people, for 12 to 20 years. Participants completed a biennial survey detailing their physical activity, television habits, alcohol use, sleep duration and diet. Their weight was measured every 4 years. The study appeared in the June 23, 2011, issue of the New England Journal of Medicine.

The researchers found several general lifestyle changes linked to weight gain over a 4-year period. Participants who increased their physical activity gained less weight than those who didn't. However, only increases in activity during the period produced this result; absolute levels of physical activity weren't associated with weight change. People who slept for less than 6 hours a day or more than 8 hours gained more weight. Increases in TV-watching led to an average gain of about a third of a pound for every hour of TV watching per day.

Food choices also affected weight. Potato chips, sugar-sweetened drinks, processed meats and unprocessed red meat were each linked to weight gain of about a pound or more. Eating more french fries led to an average gain of over 3 pounds. Eating more refined grains and sweets or desserts led to about half a pound of weight gain. By contrast, eating more vegetables, whole grains, fruits, nuts and yogurt was linked to reductions in weight over a 4-year period. Yogurt led the pack, with an average of 0.82 pounds of weight lost.

The researchers suggest that highly processed foods may not satisfy hunger as well as less processed, higher fiber foods, causing a higher total intake of calories. “The idea that there are no ‘good’ or ‘bad’ foods is a myth that needs to be debunked,” Hu says.

This was an observational study, in which people were asked to recall the foods they ate. While the findings are compelling, future controlled studies will be needed to confirm whether eating particular foods can affect long-term weight gain more than simply counting calories.

—by Allison Bierly, Ph.D.

Source:NIH

Risk in Red Meat?

 

A new study adds to the evidence that eating red meat on a regular basis may shorten your lifespan. The findings suggest that meat eaters might help improve their health by substituting other healthy protein sources for some of the red meat they eat.

Past research has tied red meat to increased risks of diabetes, cardiovascular disease and certain cancers. The studies have also pointed to an elevated risk of mortality from red meat intake. But most of these studies were done over limited periods of time, had design flaws, or were done in populations with diets other than that of the typical American.

A research team led by Dr. Frank Hu of the Harvard School of Public Health set out to learn more about the association between red meat intake and mortality. They studied over 37,000 men from the Health Professionals Follow-up Study (beginning in 1986) and over 83,000 women from the Nurses' Health Study (beginning in 1980). All the participants were free of cardiovascular disease and cancer at the start of the study.

The participants filled out food frequency questionnaires every 4 years. The scientists also gathered information every 2 years on a variety of other health factors, including body weight, cigarette smoking and physical activity level. The study was supported by NIH’s National Heart, Lung and Blood Institute (NHLBI), National Cancer Institute (NCI) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It appeared online in Archives of Internal Medicine on March 12, 2012.

Almost 24,000 participants died during the study, including about 5,900 from cardiovascular disease and about 9,500 from cancer. Those who consumed the highest levels of both unprocessed and processed red meat had the highest risk of all-cause of mortality, cancer mortality and cardiovascular disease mortality. After adjusting for other risk factors, the researchers calculated that 1 additional serving per day of unprocessed red meat over the course of the study raised the risk of total mortality by 13%. An extra serving of processed red meat (such as bacon, hot dogs, sausage and salami) raised the risk by 20%.

The researchers estimated that substituting 1 serving per day of other foods—like fish, poultry, nuts, legumes, low-fat dairy and whole grains—for red meat could lower the risk of mortality by 7% to 19%. If the participants had all consumed fewer than half a serving per day (about 1.5 ounces) of red meat, the scientists calculated, 9.3% of the deaths in men and 7.6% of the deaths in women could have been prevented.

“Our study adds more evidence to the health risks of eating high amounts of red meat, which has been associated with type 2 diabetes, coronary heart disease, stroke and certain cancers in other studies,” says lead author Dr. An Pan.

Since this was an observational study in which people reported their own food intake, it's possible that the associations seen may be due to other factors. When the researchers accounted for known risk factors in red meat—like saturated fat, dietary cholesterol and iron—they still couldn't account for all of the risk associated with eating red meat. Other mechanisms may be involved, or other unknown factors may affect the results. Further study will be needed to fully understand the connection between red meat consumption and health.

—by Harrison Wein, Ph.D.

Source:NIH

Possible clues found to why HIV vaccine showed modest protection

 

Analysis by NIH-supported scientists may help identify requirements for HIV vaccine

Insights into how the first vaccine ever reported to modestly prevent HIV infection in people might have worked were published online today in the New England Journal of Medicine. Scientists have found that among adults who received the experimental HIV vaccine during the landmark RV144 clinical trial, those who produced relatively high levels of a specific antibody after vaccination were less likely to get infected with the virus than those who did not. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, co-funded the research.

“This analysis has produced some intriguing hints about what types of human immune responses a preventive HIV vaccine may need to induce,” said NIAID Director Anthony S. Fauci, M.D. “With further exploration, this new knowledge may bring us a step closer to developing a broadly protective HIV vaccine.”

In the RV144 clinical trial, which involved more than 16,000 adult volunteers in Thailand, the group that received the vaccine had a 31 percent lower chance of becoming infected with HIV than the group that received a placebo. Since the study results were reported in 2009, a consortium of more than 100 scientists from 25 institutions has been searching for molecular clues to explain why the vaccine showed a modest protective effect.

The new report describes the researchers' analyses of blood samples taken from a representative subset of study participants: 41 who were vaccinated and later became infected with HIV and 205 vaccinated participants who remained uninfected. The participants who made relatively high levels of one antibody to HIV were significantly less likely to become infected than those who did not. This particular binding antibody attaches to a part of the outer coat of the virus called the first and second variable regions, or V1V2, which may play an important role in HIV infection of human cells. The antibody belongs to a family called immunoglobulin G, or IgG.

Vaccinated study participants who had relatively high levels of a different type of HIV binding antibody, however, appeared to have less protection from the virus than vaccinated participants who had low levels of this protein. The antibody attaches to a part of the virus's outer coat called the first constant region, or C1, and belongs to a family called immunoglobulin A, or IgA. The study team hypothesizes that the C1 IgA antibody either was associated with less benefit from HIV vaccination or directly reduced the benefit of vaccination.

“The remarkable international collaboration to understand the RV144 study results has generated important hypotheses for scientists to investigate,” said Barton F. Haynes, M.D., the leader of the new analysis and the director of the NIAID-funded Center for HIV/AIDS Vaccine Immunology based at Duke University in Durham, N.C.

Researchers plan to further evaluate the new findings in studies to be conducted in non-human primates using the RV144 vaccine regimen and other vaccines. Scientists must conduct more tests to determine whether high levels of V1V2 antibodies directly caused the modest protective effect seen in the RV144 study or simply were linked to other, still unidentified factors responsible for the trial's encouraging outcome. Such testing also will determine whether the V1V2 antibody response is merely a marker of HIV exposure or decreased susceptibility to HIV infection.

The study authors note that different vaccine candidates may protect against HIV in different ways. Therefore, more research is needed to understand whether these new findings will be relevant to other types of HIV vaccines or to similar vaccines tested against HIV strains from other regions or against different routes of exposure to the virus, according to the authors.

The RV144 laboratory research was initiated and coordinated by the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research. The U.S. Army Medical Research and Materiel Command and the Bill and Melinda Gates Foundation co-funded the research along with NIAID. NIH/NIAID provided funding through grant number U19 AI067854-07 and through HIV Vaccine Research Interagency Agreement number Y1-AI-2642.

Source: NIH

Clinical Diagnostics May 23-24, 2012

 

This year will be the 3rd annual Clinical Diagnostics  online conference. Attendees can earn free CE Credits accredited by both the AACC ACCENT and ASCLS PACE.  The theme of this conference is a range of medical and clinical topics such as Oncology, Infectious Disease, Laboratory Testing, Cardiology, Diabetes, Point of Care, Molecular Diagnostics, Hematology, Automation, Nutrition, Vitamin D, Allergy, Clinical Chemistry and much more.
This event will bring together clinicians, medical experts and professionals  from around the world to learn about recent advances in clinical diagnostics and medicine.  This conference offers an amazing opportunity as it is free to participants, and there will be no out-of-pocket expenses for travel. However, participants will still benefit from interacting with a global community of like-minded colleagues, without leaving the comfort of their office or home.
Conference participants will be able to
•        Attend interactive live streaming video sessions
•        Have their questions answered in real-time by industry experts
•        Receive Free Continuing Education Credits
•        Chat live with peers and speakers
•        Browse a virtual exhibit floor for solution providers
No crowded airports, delayed flights or expensive hotel rooms, but still the look and feel of a first-rate conference with world renowned experts. Participants also benefit from the fact that experts and vendors are more accessible, no more waiting in line to speak to someone.  Think it is too good to be true? Checkout the venue and become a believer.

Free, Register Now

Clinical Trials And You…

 

Source:NIH

 

1. WHAT ARE CLINICAL TRIALS AND WHY DO PEOPLE PARTICIPATE?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

 

2. WHAT IS CLINICAL RESEARCH?

Clinical research is medical research that involves people like you. People volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments and therapies as well as long–term natural history studies, which provide valuable information about how disease and health progress.

The idea

The idea for a clinical research study—also known as a clinical trial—often originates in the laboratory. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

The protocol

Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:

• Who is eligible to participate in the trial
• Details about tests, procedures, medications, and dosages
• The length of the study and what information will be gathered

A clinical study is led by a principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.

Protocol review

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

Sponsors

Clinical trials are sponsored or funded by various organizations or individuals, including physicians, foundations, medical institutions, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health and the Department of Veterans Affairs.

Informed consent

Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (providing additional information) continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study. Translation or interpretive assistance can be provided for participants with limited English proficiency. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information. The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract. Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.

Types of clinical trials

There are different types of clinical trials.

• Natural history studies provide valuable information about how disease and health progress.
• Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may include medicines, vaccines, or lifestyle changes, among other things.
• Screening trials test the best way to detect certain diseases or health conditions.
• Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.

Phases of clinical trials

Clinical trials are conducted in “phases.” Each phase has a different purpose and helps researchers answer different questions.

• Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
• Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
• Phase III trials: The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
• Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.

Some concepts to understand

Typically, clinical trials compare a new product or therapy with another that already exists to determine if the new one is as successful as, or better than, the existing one. In some studies, participants may be assigned to receive a placebo(an inactive product that resembles the test product, but without its treatment value).

Comparing a new product with a placebo can be the fastest and most reliable way to demonstrate the new product’s therapeutic effectiveness. However, placebos are not used if a patient would be put at risk—particularly in the study of treatments for serious illnesses—by not having effective therapy. Most of these studies compare new products with an approved therapy. Potential participants are told if placebos will be used in the study before they enter a trial.

Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice. This is done to avoid any bias with investigators assigning volunteers to one group or another.  The results of each treatment are compared at specific points during a trial, which may last for years. When one treatment is found superior, the trial is stopped so that the fewest volunteers receive the less beneficial treatment.

In single-ordouble-blind studies, also called single- or double-masked studies, the participants do not know which medicine is being used, so they can describe what happens without bias. "Blind" (or "masked") studies are designed to prevent members of the research team or study participants from influencing the results. This allows scientifically accurate conclusions. In single-blind ("single-masked") studies, only the patient is not told what is being administered. In a double-blind study, only the pharmacist knows; members of the research team are not told which patients are getting which medication, so that their observations will not be biased. If medically necessary, however, it is always possible to find out what the patient is taking.

 

3. WHO PARTICIPATES IN CLINICAL TRIALS?

Many different types of people participate in clinical trials. Some are healthy, while others may have illnesses. A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Healthy volunteers have always played an important role in research.

Healthy volunteers are needed for several reasons. When developing a new technique, such as a blood test or imaging device, healthy volunteers (formerly called "normal volunteers") help define the limits of "normal." These volunteers serve as controls for patient groups and are often matched to patients on characteristics such as age, gender, or family relationship. They receive the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the healthy volunteers.

Factors like how much of your time is needed, discomfort you may feel, or risk involved depends on the trial. While some require minimal amounts of time and effort, other studies may require a major commitment in time and effort on behalf of the volunteer, and may involve some discomfort. The research procedure may also carry some risk. The consent process for healthy volunteers includes a detailed discussion of the study's procedures and tests.

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants.

Patient volunteers may be involved in studies similar to those in which healthy volunteers participate. These studies involve drugs, devices, or interventions designed to prevent, treat, or cure disease. Although these studies may provide direct benefit to patient volunteers, the main aim is to prove, by scientific means, the effects and limitations of the experimental treatment. Consequently, some patients serve as controls by not taking the test drug, or by receiving test doses of the drug large enough only to show that it is present, but not at a level that can treat the condition. A study's benefits may be indirect for the volunteers but may help others.

All clinical trials have guidelines about who can participate, called Inclusion/Exclusion Criteria. Factors that allow someone to participate in a clinical trial are "inclusion criteria." Those that exclude or not allow participation are "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.

Some studies need both types. Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.

 

4. WHAT DO I NEED TO KNOW IF I AM THINKING ABOUT PARTICIPATING?

Risks and benefits

Clinical trials involve risks, just as routine medical care and the activities of daily living. When weighing the risks of research, you can consider two important factors:

1. the degree of harm that could result from participating in the study, and
2. the chance of any harm occurring.

Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.

Potential benefits

Well-designed and well-executed clinical trials provide the best approach for participants to:

• Play an active role in their health care.
• Gain access to new research treatments before they are widely available.
• Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
• Help others by contributing to medical research.

Potential risks

Risks to participating in clinical trials include the following:

• There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
• The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more treatments, hospital stays, or complex dosage requirements.

 

5. WHAT QUESTIONS SHOULD I ASK IF OFFERED A CLINICAL TRIAL?

If you are offered a clinical trial, feel free to ask any questions or bring up any issues concerning the trial at any time. The following suggestions may give you some ideas as you think about your own questions.

The study

• What is the purpose of the study?
• Why do researchers think the approach may be effective?
• Who will fund the study?
• Who has reviewed and approved the study?
• How are study results and safety of participants being checked?
• How long will the study last?
• What will my responsibilities be if I participate?

Possible risks and benefits

• What are my possible short-term benefits?
• What are my possible long-term benefits?
• What are my short-term risks, such as side effects?
• What are my possible long-term risks?
• What other options do people with my disease have?
• How do the possible risks and benefits of this trial compare with those options?

Participation and care

• What kinds of therapies, procedures and /or tests will I have during the trial?
• Will they hurt, and if so, for how long?
• How do the tests in the study compare with those I would have outside of the trial?
• Will I be able to take my regular medications while in the clinical trial?
• Where will I have my medical care?
• Who will be in charge of my care?

Personal issues

• How could being in this study affect my daily life?
• Can I talk to other people in the study?

Cost issues

• Will I have to pay for any part of the trial such as tests or the study drug?
• If so, what will the charges likely be?
• What is my health insurance likely to cover?
• Who can help answer any questions from my insurance company or health plan?
• Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for asking your doctor about trials

• Consider taking a family member or friend along, for support and for help in asking questions or recording answers.
• Plan ahead what to ask — but don't hesitate to ask any new questions you think of while you're there.
• Write down your questions in advance, to make sure you remember to ask them all.
• Write down the answers, so that you can review them whenever you want.
• Ask about bringing a tape recorder to make a taped record of what's said (even if you write down answers).

This information courtesy of Cancer.gov.

 

6. HOW AM I PROTECTED?

Ethical guidelines

The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patient volunteers. By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses.

Informed consent

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits.

If the participant decides to enroll in the trial, the informed consent document will be signed. Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.

IRB review

Each clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Federal regulation requires all institutions in the United States that conduct or support biomedical research involving people to have an IRB initially approve and periodically review the research.

Further reading

For more information about research protections, see:

• Office of Human Research Protection
• Children's Assent to Clinical Trial Participation

For more information on participants’ privacy and confidentiality, see:

• National Institutes of Health, HIPAA Privacy Rule

The Food and Drug Administration, FDA’s Drug Review Process:

• Ensuring Drugs Are Safe and Effective
• National Cancer Institute, Monitoring the Safety of Clinical Trials

 

7. WHAT HAPPENS AFTER A CLINICAL TRIAL IS COMPLETED?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. After a phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the agent or intervention because it was unsafe or ineffective. When a phase III trial is completed, the researchers examine the data and decide whether the results have medical importance.

Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media and discussed at scientific meetings and by patient advocacy groups before they are published. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.

Ask the research team members if the study results have been or will be published. Published study results are also available by searching for the study's official name or Protocol ID number in the National Library of Medicine's PubMed® database.

 

8. HOW DOES THE OUTCOME OF CLINICAL RESEARCH MAKE A DIFFERENCE?

Only through clinical research can we gain insights and answers about the safety and effectiveness of drugs and therapies. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those diagnosed with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As clinical research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation of volunteers is essential to help us find the answers.

Source:NIH