30 December, 2011

Lock it Up: Medicine Saftey in Your Home

Every year thousands of children are hospitalized—and some die—after taking medicine not meant for them. Teens share stolen prescription drugs at "pharm parties" and toddlers are tempted by colorful pills that look like candy. In this Consumer Update video, FDA pharmacist Connie Jung explains how you can prevent harm by locking your medicine up

Ten Tips to Prevent an Accidental Overdose

For a medicine to work for you—and not against you—you’ve got to take the right dose.

Many over-the-counter liquid medicines—such as pain relievers, cold medicine,

cough syrups, and digestion aids—come with spoons, cups, oral droppers, or syringes designed to help consumers measure the proper dose. These “dosage delivery devices” usually have measurement markings on them—such as teaspoons (tsp), tablespoons (tbsp), or milliliters (mL).

But the markings aren’t always clear or consistent with the directions on the medicine’s package. The Food and Drug Administration (FDA) has received numerous reports of accidental overdoses—especially in young children—that were attributed, in part, to the use of dosage delivery devices that were unclear or incompatible with the medicine’s labeled directions for use.

On May 4, 2011, FDA issued a guidance to firms that manufacture, market, or distribute over-the-counter liquid medicines. The guidance calls for them to provide dosage delivery devices with markings that are easy to use and understand.

Parents and caregivers can do their part, too, to avoid giving too much or too little of an over-the-counter medicine. Here are 10 tips:

  1. Always follow the directions on the Drug Facts label of your medicine. Read the label every time before you give the medicine.
  2. Know the "active ingredient" in the medicine. This is what makes the medicine work and it is always listed at the top of the Drug Facts label. Many medicines used to treat different symptoms have the same active ingredient. So if you're treating a cold and a headache with two different medicines but both have the same active ingredient, you could be giving two times the normal dose. If you're confused, check with a doctor, nurse, or pharmacist.
  3. Give the right medicine, in the right amount. Medicines with the same brand name can be sold in different strengths, such as infant, children, and adult formulas. The dose and directions also vary for children of different ages or weights. Always use the right strength and follow the directions exactly. Never use more medicine than directed unless your doctor tells you to do so.
  4. Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn't. Medicines, vitamins, supplements, foods, and beverages aren’t always compatible.
  5. Use the dosage delivery device that comes with the medicine, such as a dropper or a dosing cup. A different device, or a kitchen spoon, could hold the wrong amount of medicine. And never drink liquid medicine from the bottle.
  6. Know the difference between a tablespoon (tbsp) and a teaspoon (tsp). A tablespoon holds three times as much medicine as a teaspoon. On measuring tools, a teaspoon (tsp) is equal to "5 mL."
  7. Know your child's weight. Dosage amounts for some medicines are based on weight. Never guess how much to give your child or try to figure it out from the adult dose instructions. If a dose is not listed for your child's weight, call your health care professional.
  8. Prevent a poison emergency by always using a child-resistant cap. Relock the cap after each use. Be especially careful with any medicines that contain iron; they are the leading cause of poisoning deaths in young children.
  9. Store all medicines in a safe place. Some are tasty, colorful, and many can be chewed. Kids may think they’re candy. Store all medicines and vitamins out of your child's (and your pet's) sight and reach. If your child takes too much, call the Poison Center Hotline at 800-222-1222 (open 24 hours a day, 7 days a week) or call 9-1-1.
  10. Check the medicine three times before using. For any medicine, it is always good practice to first, check the outside packaging for such things as cuts, slices, or tears. Second, once you’re at home, check the label on the inside package to be sure you have the right medicine and that the lid and seal are not broken. Third, check the color, shape, size, and smell. If you notice anything unusual, talk to a pharmacist or other health care professional before using.

Key Hearing Proteins Identified

 

Researchers have found what appear to be 2 key components of the long-sought-after mechanotransduction channel in the inner ear—the place where sound waves are transformed into the electrical signals that the brain recognizes as sound.

Photo of a young woman cupping her hand to her ear.

Sensory cells in the inner ear called hair cells are crucial for transforming sound into electrical signals. Hair cells also underlie our sense of balance. Sitting atop hair cells are tiny bristly structures called stereocilia. Microscopic tethers connect the tips of shorter stereocilia to the sides of adjacent taller stereocilia. Most scientists believe that as the stereocilia move, the tethers open ion channels—tiny openings in the cell that let electrically charged molecules (ions) pass in and out. The ions rushing inside begin an electrical signal that travels to the brain.

While researchers have gained many insights into mechanotransduction, the ion channels involved have remained elusive. A team of researchers led by Dr. Andrew J. Griffith of NIH's National Institute on Deafness and Other Communication Disorders (NIDCD) and Dr. Jeffrey R. Holt of Harvard Medical School decided to focus on 2 proteins. Griffith and other collaborators had previously found that mutations in the TMC1 gene cause hereditary deafness in both humans and mice. The TMC1 protein sequence suggests that it could span the cell's outer membrane and act as a channel. Another protein, TMC2, has a similar structure. The scientists deleted both genes in mice. Their findings appeared on December 1, 2011, in theJournal of Clinical Investigation.

Mice with no functional copies of TMC1 or TMC2 had the classic behaviors of dizzy mice—head bobbing, neck arching, unstable gait and circling movements. They were also deaf. The TMC1 deficient mice were deaf as well, but had no balance issues. Mice without TMC2 had no problems with hearing or balance.

The scientists examined when the TMC1 and TMC2 genes are expressed (turned on) in the inner ears of mice. The 2 genes were expressed from birth in hair cells in both the cochlea, which is responsible for hearing, and the vestibular organs, which are responsible for balance. When mice were a week old, TMC2 appeared to be turned off in the cochlea but not in the vestibular organs. TMC1 continued to be expressed in mature cochlear hair cells. Taken toghter, these findings suggest that TMC1 is essential for hearing, but TMC2 is not. For balance, however, TMC2 can substitute for TMC1.

In laboratory tests, hair cells lacking functional TMC1 or TMC2 had no detectable mechanotransduction currents, even though the rest of the cells' structure and function appeared normal. By using a gene therapy technique that adds proteins back into cells, the researchers were able to restore transduction to both vestibular and cochlear hair cells. This finding suggests that it might be possible to reverse these genetic deficits.

The researchers found that TMC1 and TMC2 cluster at the tips of the stereocilia, where one might expect to see proteins that play a prominent role in mechanotransduction. In future work, the scientists intend to explore how TMC1 and TMC2 interact with each other as well as with other known proteins at the stereocilia tip.

A Key to Choosing Healthful Foods: Using the Nutrition Facts on the Food Label

Have you ever read the Nutrition Facts label on food Reading Nutrition Labelpackages and wondered: serving sizes, percentages, daily values – what do they all mean? Well, you're not alone. Many consumers would like to know how to use the Nutrition Facts label more easily and effectively — and help is finally here. Use this information to make quick, informed food choices that contribute to healthy lifelong eating habits for you and your family.

Product Info and "Daily Values"

The Nutrition Facts label is divided into Two Main Areas:

Sections 1-5 provide product-specific information (serving size, calories, and nutrient information). These vary with each food product.

Section 6 is a Footnote with Daily Values (DVs). The footnote provides information about the DVs for important nutrients, including fats, sodium and fiber. The DVs are listed for people who eat 2,000 or 2,500 calories each day.

  • The amounts for total fat, saturated fat, cholesterol, and sodium are maximum amounts. That means you should try to stay below the amounts listed.
  • The DVs for total carbohydrate and dietary fiber daily represent the minimum amounts recommended for a 2,000-calorie diet. This means you should consume at least this amount per day for each of these nutrients.
  • The footnote is only found on larger labels, and does not change from product to product.
Details on the Daily Value

3 Easy Ways to Use the % Daily Value

  1. Look at highs and lows.
    The %DV gives you a framework for deciding if a food is high or low in a nutrient. Use the Quick Guide to %DV: 5% or less is low and 20% or more is high.

    Compare products – Use the %DV to compare one food product or brand to a similar product. Make sure the servings sizes are similar, especially the weight (e.g., gram, milligram, ounces) of each product so you can see which foods are higher or lower in nutrients.

  1. Evaluate claims.
    So you don't have to memorize definitions, use the %DV to help you quickly distinguish one claim from another, such as "reduced fat" vs. "light" or "nonfat." Just compare the %DVs for Total Fat in each food product to see which one is higher or lower in that nutrient. There is no need to memorize definitions. This works when comparing all nutrient content claims, e.g., less, light, low, free, more, high, etc.
  2. Make dietary trade-offs.
    Make dietary trade offs using the %DV. For example, when a food you like is high in saturated fat, select foods that are low in saturated fat at other times of the day.

What's On the Label?

Nutrition Label divided into 6 sections: 1. Serving Size, 2. Amount of Calories, 3. Limit these Nutrients, 4. Get enough of these Nutrients, 5. Percent (%) Daily Value

  1. Serving Size

    This section is the basis for determining number of calories, amount of each nutrient, and %DVs of a food. Use it to compare a serving size to how much you actually eat. Serving sizes are given in familiar units, such as cups or pieces, followed by the metric amount, e.g., number of grams.

  2. Amount of Calories

    If you want to manage your weight (lose, gain, or maintain), this section is especially helpful. The amount of calories is listed on the left side. The right side shows how many calories in one serving come from fat. In this example, there are 250 calories, 110 of which come from fat. The key is to balance how many calories you eat with how many calories your body uses. Tip: Remember that a product that's fat-free isn't necessarily calorie-free.

  3. Limit these Nutrients

    Eating too much total fat (including saturated fat and trans fat), cholesterol, or sodium may increase your risk of certain chronic diseases, such as heart disease, some cancers, or high blood pressure. The goal is to stay below 100%DV for each of these nutrients per day.

  4. Get Enough of these Nutrients

    Americans often don't get enough dietary fiber, vitamin A, vitamin C, calcium, and iron in their diets. Eating enough of these nutrients may improve your health and help reduce the risk of some diseases and conditions.

  5. Percent (%) Daily Value

    This section tells you whether the nutrients (total fat, sodium, dietary fiber, etc.) in one serving of food contribute a little or a lot to your total daily diet.

    The %DVs are based on a 2,000-calorie diet. Each listed nutrient is based on 100% of the recommended amounts for that nutrient. For example, 18% for total fat means that one serving furnishes 18% of the total amount of fat that you could eat in a day and stay within public health recommendations. Use the Quick Guide to Percent DV (%DV): 5%DV or less is low and 20%DV or more is high.

  6. Footnote with Daily Values (%DVs)

    The footnote provides information about the DVs for important nutrients, including fats, sodium and fiber. The DVs are listed for people who eat 2,000 or 2,500 calories each day.

—The amounts for total fat, saturated fat, cholesterol, and sodium are maximum amounts. That means you should try to stay below the amounts listed.

Food Facts         photos of lab scientist, laboratory, produce, and inspector looking at fish            

From the U.S. Food and Drug Administration         

Eat for a Healthy Heart

 

Eat for a Healthy Heart - Sidebar - Recipe Image 

Making healthy food choices is one important thing you can do to reduce your risk of heart disease—the leading cause of death of men and women in the United States.

According to the American Heart Association, about 80 million adults in the U.S. have at least one form of heart disease—disorders that prevent the heart from functioning normally—including coronary artery disease, heart rhythm problems, heart defects, infections, and cardiomyopathy (thickening or enlargement of the heart muscle).

Experts say you can reduce the risk of developing these problems with lifestyle changes that include eating a healthy diet. But with racks full of books and magazines about food and recipes, what is the best diet for a healthy heart?

Food and Drug Administration nutrition expert (FDA's) Barbara Schneeman says to follow these simple guidelines when preparing meals:

  • Balance calories to manage body weight
  • Eat at least 4.5 cups of fruits and vegetables a day, including a variety of dark-green, red, and orange vegetables, beans, and peas.
  • Eat seafood (including oily fish) in place of some meat and poultry
  • Eat whole grains—the equivalent of at least three 1-ounce servings a day
  • Use oils to replace solid fats.
  • Use fat-free or low-fat versions of dairy products.

The government’s newly released “Dietary Guidelines for Americans 2010” also says Americans should reduce their sodium intake. The general recommendation is to eat less than 2,300 mg. of sodium a day. But Americans 51 or older, African-Americans of any age, and people with high blood pressure, diabetes, or chronic kidney disease should restrict their intake to 1,500 mg. The government estimates that about half the U.S. population is in one of those three categories.

 

Packaged and Restaurant Food

Schneeman, who heads FDA's Office of Nutrition, Labeling, and Dietary Supplements, says one way to make sure you’re adhering to healthy guidelines is by using the nutrition labels on the packaged foods you buy.

“Product labels give consumers the power to compare foods quickly and easily so they can judge which products best fit into a heart healthy diet or meet other dietary needs,” Schneeman says. “Remember, when you see a percent DV (daily value of key nutrients) on the label, 5 percent or less is low and 20 percent or more is high.”

Follow these guidelines when using processed foods or eating in restaurants:

  • Choose lean meats and poultry. Bake it, broil it, or grill it.
  • In a restaurant, opt for steamed, grilled, or broiled dishes instead of those that are fried or sautéed.
  • Look on product labels for foods low in saturated fats, trans fats, and cholesterol. Most of the fats you eat should come from polyunsaturated and monounsaturated fats, such as those found in some types of fish, nuts, and vegetable oils.
  • Check product labels for foods high in potassium (unless you’ve been advised to restrict the amount of potassium you eat). Potassium counteracts some of the effects of salt on blood pressure.
  • Choose foods and beverages low in added sugars. Read the ingredient list to make sure that added sugars are not among the first ingredients. Ingredients in the largest amounts are listed first. Some names for added sugars include sucrose, glucose, high fructose corn syrup, corn syrup, maple syrup, and fructose. The nutrition facts on the product label give the total sugar content.
  • Pick foods that provide dietary fiber, like fruits, beans, vegetables, and whole grains.

Know Concentration Before Giving Acetaminophen to Infants

 

Know Concentration Before Giving Acetaminophen to Infants - (JPG)

The Food and Drug Administration (FDA) is urging consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their children.

A less concentrated form of the popular medication is arriving on store shelves, and giving the wrong dose of acetaminophen can cause the medication to be ineffective if too little is given or cause serious side effects and, possibly, death if too much is given.

In an attempt to reduce the confusion over different strengths that have been blamed for past overdoses, some manufacturers are voluntarily offering only the less concentrated version for all children.

Until now, liquid acetaminophen marketed for infants has only been available in a stronger concentration that doesn’t require giving the infants as much liquid with each dose.

But right now both concentrations of liquid acetaminophen are in circulation. Before giving the medication, parents and caregivers need to know whether they have the less concentrated version or the older, more concentrated medication. FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused.

“Be very careful when you’re giving your infant acetaminophen” says Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis.

Here’s what the agency wants parents and caregivers to do:

  • Read the Drug Facts label on the package very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
  • Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
  • Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
  • Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration.

 

Overdosing Has Been a Risk

An April 2011 report from FDA’s Center for Drug Evaluation and Research (CDER) found that confusion caused by the different concentrations of liquid acetaminophen for infants and children was leading to overdoses that made infants seriously ill, with some dying from liver failure.

So to avoid dosing errors, some manufacturers voluntarily changed the liquid acetaminophen marketed for infants from 80 mg per 0.8mL or 80 mg per 1 mL to be the same concentration as the liquid acetaminophen marketed for children—160 mg per 5mL. This less concentrated liquid acetaminophen marketed for infants now has new dosing directions and may have a new dosing device in the box, such as an oral syringe.

But this is a voluntary change and some of the older, stronger concentrations of acetaminophen marketed for infants are still available and may remain available.

“There is still some on store shelves; there is still some in homes; and there is still some in distribution,” says Holquist.

 

Why does this pose a danger?

If a pediatrician prescribes a 5 mL dose of the less concentrated liquid acetaminophen, but the parents administer a 5 mL dose of the more concentrated liquid acetaminophen, the child can receive a potentially fatal overdose during the course of therapy, Holquist explains.

Conversely, if a physician prescribes a dose based on the more concentrated liquid acetaminophen and the less concentrated medication is used, the child might not receive enough medication to fight a fever, she says.

FDA has issued a Drug Safety Communication with more information for consumers about how to avoid confusion and potential dosing errors with the different concentrations of liquid acetaminophen.

 

What Should You Do?

Adding to the confusion is the fact that that the box and the bottle may look much the same for both old and new versions of the medication, Holquist says.

Read the Drug Facts label to tell the difference between the two liquid acetaminophen products:

  • Look for the “Active ingredient” section of the Drug Facts label usually printed on the back of an over-the-counter (OTC) medication package. 
  • If the package says “160 mg per 5 mL” or “160 mg (in each 5 mL)”, then this is the less concentrated liquid acetaminophen.  This medication should come with an oral syringe to help you measure the dose.
  • If the package says “80 mg per 0.8 mL” or “80 mg per 1 mL,” then this is the more concentrated liquid acetaminophen. This product may come with a dropper.

17 December, 2011

Study shows additional benefits of progesterone in reducing preterm birth risk

 

NIH study finds that treatment with hormone benefits women with short cervix

An analysis of five previous studies has uncovered additional evidence of the effectiveness of progesterone, a naturally occurring hormone, in reducing the rate of preterm birth among a high-risk category of women.

Pregnant women in this category, who have a short cervix, are at increased risk of delivering early. The cervix is the part of the uterus that shortens and opens during labor for the infant to pass through. Preterm infants, born three weeks or more before a full 40-week term, are at increased risk for death in the first year of life, as well as for breathing difficulties, cerebral palsy, learning disabilities, blindness and deafness.

A previous NIH study had earlier indicated that progesterone was effective in reducing the preterm birth rate.

The current study is a meta-analysis, a statistical technique that combines the data from several studies addressing a related research question. The study is published online in the American Journal of Obstetrics and Gynecology.

The researchers found that the treatment tested in the previous studies substantially reduced the risk of delivery in the 27th to 34th weeks of gestation. For example, progesterone reduced preterm delivery before week 28 by half. The researchers analyzed studies testing vaginal progesterone formulations, in doses ranging from 90 milligrams to 200 milligrams per day.

The researchers also concluded that even when the mother delivers before full term, progesterone treatment can reduce the likelihood that the infant will die (by 43 percent), have respiratory distress syndrome (by 52 percent), weigh less than 3.5 pounds (by 45 percent), be admitted for intensive care (by 25 percent), or require mechanical ventilation (by 34 percent).

Based on their findings, the researchers recommended that doctors screen pregnant patients with ultrasound of the cervix routinely at 19 to 24 weeks of gestation. If physicians detect a short cervix (10 to 20 millimeters) with ultrasound, the study authors recommended treatment with 90 mg per day of progesterone is recommended between weeks 20 and 37.

"These findings confirm that routine screening and treatment with vaginal progesterone can greatly reduce the rate of preterm birth in women with a short cervix and reduce the occurrence of the complications of prematurity among their infants," said first author Roberto Romero, M.D., chief of the Perinatology Research Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NIH institute that led the study.

Dr. Romero and colleagues at the NICHD Perinatology Research Branch collaborated with 14 co-authors from institutions elsewhere in the United States and in Austria, Brazil, Denmark, India, South Africa, Turkey, and the United Kingdom.

Combining information from the five studies, the researchers analyzed data from 775 women. Comparing women who received progesterone treatment with those who did not, the researchers separately calculated the rate of preterm delivery at each week of gestation.

Preterm delivery is known to raise the risk of a preterm birth in subsequent pregnancies. However, the researchers found that women with a short cervix who previously had given birth preterm benefitted from progesterone treatment as much as did those who did not have a history of preterm delivery.

Differences in the rate of preterm birth were seen in the weeks shown in the chart below. The original studies did not have sufficient data to compare results for infants born before week 32.

10 December, 2011

The Mystery of Multiple Sclerosis


No Simple Explanation

Cartoon of a woman describing symptoms to her doctor.

Multiple sclerosis (MS) disrupts communication between the brain and other parts of the body.  In the worst cases, it can bring partial or complete paralysis. Researchers don’t yet know what causes this disease or how to cure it, but they’ve been making progress on both fronts.

Symptoms of MS arise most often between the ages of 20 and 40. It often begins with blurred or double vision, color distortion, or even blindness in one eye. It can cause muscle weakness, vision loss, numbness or tingling, and difficulty with coordination and balance. MS can bring many other symptoms as well.

In some people, doctors may not be able to readily identify the cause of these symptoms. Patients may endure years of uncertainty and multiple diagnoses while baffling symptoms come and go.  The vast majority of patients are mildly affected, but in the worst cases, MS can leave a person unable to write, speak or walk.

MS is a disease in which the body’s immune system inappropriately attacks the brain and spinal cord. Specifically, the immune system targets the fatty insulating material around nerves called myelin. When myelin is damaged, the messages that nerve cells send and receive can be interrupted.

Researchers estimate that 250,000 to 350,000 people in the United States have been diagnosed with MS. Scientists don’t yet understand what triggers the immune system to attack myelin in these people. But researchers do know that whites are more than twice as likely as others to develop MS, and women almost twice as likely as men.

Geography seems to play a role in MS. The disease is much more prevalent in temperate climates than in tropical regions. Your risk for MS seems to depend on where you live
before the age of 15. Some studies have found that a person who moves before the age of 15 tends to adopt the risk of the new area. People moving after age 15 seem to maintain the risk level of the area where they grew up. Some researchers believe that vitamin D, which the body makes when sunlight strikes the skin, may lower the risk of MS and help explain these findings, but studies haven’t yet confirmed this link.

Some microbes, such as the Epstein-Barr virus, have been suspected of causing MS. But researchers haven’t been able to prove for certain that any microbes raise your chances of getting MS. Cigarette smoking, however, does appear to raise your risk.

Genes clearly affect how likely you are to develop MS. Having a sibling with MS raises your risk of getting MS to about 4% to 5%; having an identical twin raises your risk to about 25% to 30%. These facts suggest a strong genetic component to MS. However, although some studies have linked specific genes to MS, most of the results haven’t been definitive. Researchers are now working on more detailed studies.

There’s no cure yet for MS, but various therapies can treat it. Researchers are continuing to develop new and better therapies for MS, with several now in the pipeline.

Weighing in on Dietary Fats

Some Fats Are Healthier Than Others

Cartoon of a woman in a kitchen using “good” fat or low-fat foods.
With the winter holidays upon us, you’ll likely be surrounded by family, friends and plenty of good food. Many of these foods, though, can be high in fat. Learn which fats are naughty and which are nice to your health. Then you can make smarter food choices.

We need a certain amount of fat in our diets to stay healthy. Fats provide needed energy in the form of calories. Fats help our bodies absorb important vitamins—called fat-soluble vitamins—including vitamins A, D and E. Fats also make foods more flavorful and help us feel full. Fats are especially important for infants and toddlers, because dietary fat contributes to proper growth and development.

“Fats are really the most concentrated source of energy in the foods we eat, and our bodies need that energy,” says NIH nutritionist Dr. Margaret McDowell. “Fats are truly an essential nutrient.”

Problems arise, though, if we eat too much fat. Dietary fats have more than twice as many calories per gram as either proteins or carbohydrates like sugar and starch. Excess calories, of course, can pack on the pounds and raise your risk for diabetes, cancer and other conditions.

Eating the “wrong” kinds of fats can trigger additional health hazards. “Some fats are better for our bodies than others,” McDowell says. “We should really aim to eat the right types of fats.”

Foods can contain a mixture of different fats. Unsaturated fats are considered “good” fats. They’re sometimes listed as “monounsaturated” and “polyunsaturated” fat on Nutrition Facts labels. These can promote health if eaten in the right amounts. They are generally liquid at room temperature, and are known as oils. You’ll find healthful unsaturated fats in fish, nuts and most vegetable oils, including canola, corn, olive and safflower oils.

The so-called “bad” fats are saturated fats and trans fats. They tend to be solid at room temperature. Solid fats include butter, meat fats, stick margarine, shortening, and coconut and palm oils. They’re often found in chocolates, baked goods, and deep-fried and processed foods.

“When we eat too many solid fats, we put our bodies at risk. These fats tend to raise total blood cholesterol, as well as the part of cholesterol known as low-density lipoprotein (LDL) cholesterol,” says McDowell. “When those cholesterol levels are out of whack and too high, it’s a risk factor for cardiovascular disease.”

“When there’s too much cholesterol in the blood, the excess can get trapped in artery walls and build up,” adds Dr. Catherine Loria, an NIH expert on nutrition and heart health. “The buildup can develop into atherosclerosis, or hardening of the arteries, which can lead to coronary heart disease.”

Experts say that the total fat intake for adults ages 19 and older should be 20% to 35% of the calories eaten each day. For children ages 4 to 18, it should be 25% to 35%.

Experts also say you should get less than 10% of your calories from saturated fatty acids. NIH-funded studies have shown that replacing the solid fats in your diet with healthful unsaturated fats can have a positive impact. “When you look at total fat intake, using unsaturated fats in place of some of the saturated fats actually lowers your total cholesterol levels, and mainly your LDL cholesterol levels, which is a good thing,” says Loria.

Other NIH-funded research found that, when it comes to weight loss, the source of calories—whether from fat, protein or carbohydrate—isn’t as important as the number of calories you consume. But when it comes to risk factors for heart disease, replacing some carbohydrates with protein or unsaturated fats can greatly improve blood cholesterol. In a specialized diet designed to lower blood pressure, using unsaturated fats in place of some carbohydrates boosted blood levels of “good” cholesterol (HDL cholesterol) and caused a more healthful drop in blood pressure. 

“It’s about becoming a label reader,” says Joanne Gallivan, a registered dietitian who heads NIH’s National Diabetes Education Program. To eat healthy, she says, “you need to read the Nutrition Facts label to learn the amount of fat and calories in the food, the amounts per serving, and what percent of calories come from fat.” The nutrition label also shows the amounts of unhealthy saturated and trans fats.

Eating healthy fats and less total fat can be especially challenging over the holidays, however. “You want to enjoy the foods and the celebration. You shouldn’t think of the holidays as a time to deprive yourself,” says McDowell.

One way to cut fat at holiday gatherings is to simply reduce your portion sizes. “Choose more lean meats, like poultry without the skin. Eat more fruits, vegetables and whole-grain foods,” says Gallivan.

When preparing recipes, try to use lower-fat ingredients. “Low-fat and fat-free yogurt and milk still contain the important proteins and minerals found in the full-fat versions, but you’re getting less saturated fat and cholesterol,” McDowell says. “In some recipes, you can use applesauce or egg whites, instead of oil. In general, bake, broil or grill instead of frying.”

Learn to read between the lines on Nutrition Facts labels. “If a food is labeled ‘low-fat,’ that doesn’t necessarily mean it’s low in calories,” says Gallivan. Nonfat cookies, crackers and other products may contain added sugar and salt to boost their flavor. Added sugar can add calories, and too much salt can raise blood pressure.

“If you indulge a bit over the holidays, just be sure that the next day you go back to following a healthy meal plan and being active,” says Gallivan. And remember, when it comes to saturated or trans fats in your diet, you’ll help your health if you choose wisely and trim the fat.

HCG Diet Products Are Illegal

 

HCG Diet Products Are IllegalAnyone who has ever been on a diet—and there are many of us—knows that there are sensible ways to lose weight. These include balanced diets, exercising and realistic goals.

And then there are reckless ways to shed pounds—fads and diet aids that promise rapid weight loss, but often recommend potentially dangerous practices. These include HCG weight-loss products marketed over-the-counter (OTC) that are identified as "homeopathic" and direct users to follow a severely restrictive diet.

The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products.  They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. 

FDA and the Federal Trade Commission (FTC) have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by FDA, and that make unsupported claims. 

(For the list of manufacturers, distributors and products—and more information about FDA’s concerns about HCG—visitwww.fda.gov/hcgdiet.)

 

HCG is a hormone that is produced by the human placenta during pregnancy.

Products that claim to contain HCG are typically marketed in connection with a very low calorie diet, usually one that limits calories to 500 per day. Many of these popular HCG products claim to “reset your metabolism,” change “abnormal eating patterns,” and shave 20-30 pounds in 30-40 days.

“These products are marketed with incredible claims and people think that if they're losing weight, HCG must be working,” says Elizabeth Miller, acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud. “But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG.”

HCG is approved by FDA as a prescription drug for the treatment of female infertility, and other medical conditions. It is not approved for weight loss. In fact, the prescription drug label notes there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

HCG is not approved for OTC sale for any purpose.

24 November, 2011

Genes and the Brain

 

Two related studies revealed gene activity in the brains of people of different genders and ethnicities, from fetal development to old age. The accomplishment provides a broad foundation for understanding both normal brain development and what goes awry in mental disorders.

Illustration of colorful gears forming the shape of a human brain.

Messenger RNAs, or transcripts, are transient copies of genes that carry instructions to the protein-making machinery within cells. Transcripts are made, or “expressed,” in patterns that are influenced by the approximately 1.5 million DNA variations unique to each of us. Dr. Joel Kleinman of NIH's National Institute of Mental Health (NIMH) and NIMH grantee Dr. Nenad Sestan of Yale University led a broad survey to find which genes are active in different areas in the brain at different stages of life. The sister studies appeared in the October 27, 2011, issue of Nature.

One team focused on how genetic variations are linked to the expression of transcripts in the brain's prefrontal cortex—the area that controls insight, planning and judgment—across the lifespan. The researchers studied 269 postmortem, healthy human brains ranging in age from 2 weeks after conception to 80 years old. The other study looked at expression across 16 brain regions in 57 postmortem brains—from 40 days post-conception to 82 years old—from males and females of multiple ethnicities.

The researchers found that different sets of genes are expressed during prenatal development, infancy and childhood. Three-fourths of genes change expression levels immediately after birth, with most decreasing. Gene expression gradually declines from there, eventually leveling off in middle age. It then surges again as the brain ages in the last decades of life.

Individual genetic variations are profoundly linked to expression patterns. However, despite differences in the genetic code across individuals and ethnicities, the transcriptomes—the complete set of expressed transcripts—of human brains are generally similar.

Over 90% of the genes expressed in the brain are differentially regulated across brain regions and/or over developmental periods. Brain location and timing, the researchers found, affect gene expression far more than gender, ethnicity or individual variation.

The researchers have now created large databases that reveal when and where genes turn on and off in multiple brain regions throughout development.  This information will help to show how genetic variations affect development and how they might lead to mental illness.

“Having at our fingertips detailed information about when and where specific gene products are expressed in the brain brings new hope for understanding how this process can go awry in schizophrenia, autism and other brain disorders,” says NIMH Director Dr. Thomas R. Insel.

Stroke Risk Factors Linked to Cognitive Problems

A new study found that high blood pressure and other known risk factors for stroke may also raise the risk of developing cognitive problems. The finding suggests that keeping blood pressure under control might help preserve cognitive health.

Photo of a confused man in a grocery store.

Strokes occur when blood vessels that supply the brain rupture or become blocked. When blood can't bring nutrients and oxygen to brain cells, the cells stop functioning and die. A stroke can cause a host of cognitive disabilities. These include effects on memory, speech and language, and everyday problem solving.

Even without suffering a stroke, people at risk for stroke might experience cognitive problems as their blood vessels deteriorate. The Reasons for Geographic and Racial Differences in Stroke study was funded by NIH's National Institute of Neurological Disorders and Stroke (NINDS) to analyze stroke risk and cognitive health. Since 2003, the nationwide study has followed more than 30,000 African American and Caucasian participants who were age 45 or older at enrollment. The study is led by Dr. George Howard at the University of Alabama at Birmingham.

For the latest analysis, the research team examined data on the nearly 24,000 study participants who had no history of cognitive impairment or stroke and no evidence of stroke during the study. At the start, the researchers assessed each person's stroke risk with the Framingham Stroke Risk Profile. The profile considers age, high blood pressure, diabetes and heart problems. The scientists assessed cognitive health with a 6-item screening test that required participants to give the year, month and day, and to remember 3 items from a list after a short delay. The test was repeated annually for an average of 4 years. Results appeared in the November 8, 2011, issue of Neurology.

Over the course of the study, more than 1,900 people without an evident stroke showed cognitive impairment. Baseline Framingham Stroke Risk score was associated with impairment. Age and left ventricular hypertrophy (LVH, an enlargement of the heart) independently predicted cognitive decline. Each 10-year increment in age doubled the risk of cognitive impairment. LVH increased the risk by about 30%.

Since LVH can result from high blood pressure, the researchers did a separate analysis excluding people with LVH. In this smaller group, high blood pressure proved to be an independent predictor of cognitive decline. Each systolic blood pressure increase of 10 mm Hg bumped up the risk of cognitive decline by 4%.

Consistent with a prior finding from the study, demographic risk factors for stroke were also risk factors for cognitive decline. Men, African Americans of both sexes, and residents of the Stroke Belt (Alabama, Arkansas, Georgia, Louisiana, Mississippi, North Carolina, South Carolina and Tennessee) had a higher risk of cognitive decline. Education was also a factor, with a higher level of education linked to a reduced risk of cognitive decline.

Those who experienced cognitive decline may have had silent strokes or other undetected changes that affect the brain's blood supply, says first author Dr. Frederick Unverzagt of the Indiana University School of Medicine in Indianapolis. "Our results emphasize the importance of early intervention to treat high blood pressure and preserve cognitive health prior to a stroke or other cerebral event," he says.

30 October, 2011

Safe Food Handling; What You Need To Know

 

image

Study Points to Potential Treatment for Sickle Cell Disease

       Scientists corrected sickle cell disease in adult laboratory mice by activating production of a special blood protein normally produced only before birth. The approach may lead to new treatments for people with the blood disorder.

Illustration of red blood cells flowing through a blood vessel.

Sickle cell disease is caused by an abnormality in hemoglobin, the protein in red blood cells that carries oxygen throughout the body. About 100,000 Americans live with sickle cell disease. It is most prevalent in people of African, Hispanic, Mediterranean and Middle Eastern descent.

People with sickle cell disease have 2 copies of an altered hemoglobin gene. The defective protein that results changes shape after releasing its oxygen. This causes red blood cells to become stiff, misshapen and sticky. These sickle-shaped cells slow blood flow to tissues, resulting in organ damage.

There is no widely available cure for sickle cell disease. Bone marrow transplants have cured some patients. However, the treatment poses several risks, and most patients don’t have relatives who can donate compatible, healthy bone marrow.

Past studies have shown that an elevated level of a form of hemoglobin called fetal hemoglobin reduces the tendency of sickle hemoglobin to change the shape of red blood cells. Production of fetal hemoglobin normally predominates before birth but turns off as adult hemoglobin takes over. A drug called hydroxyurea can boost production of fetal hemoglobin and reduce the complications of sickle cell disease. However, not all patients respond well to this medication, and adverse side effects are a concern.

A research team led by Dr. Stuart Orkin set out to explore a more targeted approach to raising fetal hemoglobin by blocking production of a protein called BCL11A. The team—at Harvard Medical School, Children’s Hospital of Boston and the Howard Hughes Medical Institute, Boston—had previously demonstrated that BCL11A suppresses the production of fetal hemoglobin soon after birth. Their work was funded 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). The study appeared in the October 13, 2011, online edition of Science.

The scientists used a genetic technique to inactivate the gene for BCL11A in mice with sickle cell disease. Without BCL11A, the mice continued to produce fetal hemoglobin. Sickled cells were absent in the mice, as were their disease symptoms. Other aspects of blood production appeared to be unaffected.

“This study provides the first proof of principle that BCL11A might serve as a target for treating sickle cell disease and related blood disorders such as the thalassemias,” Orkin says. More research is needed, however, before such therapies can be tested in people.

23 October, 2011

Commonly used three-drug regimen for idiopathic pulmonary fibrosis found harmful

 

NIH stops one treatment arm of trial; other two treatments to continue

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has stopped one arm of a three arm multi-center, clinical trial studying treatments for the lung-scarring disease idiopathic pulmonary fibrosis (IPF) for safety concerns. The trial found that people with IPF receiving a currently used triple-drug therapy consisting of prednisone, azathioprine, and N-acetylcysteine (NAC) had worse outcomes than those who received placebos or inactive substances.

"These findings underscore why treatments must be evaluated in a rigorous manner," said Susan B. Shurin, M.D., acting director of the NHLBI. "This combination therapy is widely used in patients with IPF, but has not previously been studied in direct comparison to a placebo for all three drugs."

The interim results from this study showed that compared to placebo, those assigned to triple therapy had greater mortality (11 percent versus 1 percent), more hospitalizations (29 percent versus 8 percent), and more serious adverse events (31 percent versus 9 percent) and also had no difference in lung function test changes. Participants randomly assigned to the triple- therapy arm also remained on their assigned treatment at a much lower rate (78 percent adherence versus 98 percent adherence).

"Anyone on some combination of these medications with questions or concerns should consult with their health care provider and not simply stop taking the drugs," said Ganesh Raghu, M.D., professor of medicine at the University of Washington, Seattle and a co-chair of this IPF study. "It is important to realize that these results definitively apply only to patients with well-defined IPF and not to people taking a combination of these drugs for other lung diseases or conditions."

The other two study arms, or intervention groups, of this IPF trial comparing NAC alone to placebo alone will continue. In stopping this part of the trial, the NHLBI accepted the recommendation of the Data and Safety Monitoring Board (DSMB) – an independent advisory group of experts in lung disease, biostatistics, medical ethics, and clinical trial design. The DSMB has been monitoring the study since it began.

This study, called PANTHER-IPF (Prednisone, Azathioprine, and N-acetylcysteine: A Study that Evaluates Response in Idiopathic Pulmonary Fibrosis) was designed and conducted by the Idiopathic Pulmonary Fibrosis Clinical Research Network, funded by the NHLBI. The PANTHER-IPF study was designed to evaluate whether this commonly used triple-therapy regimen could slow disease progression and improve lung function in people with moderate IPF.

PANTHER-IPF was the first study in IPF comparing the effectiveness of this combined treatment to a placebo for all three drugs. Each participant had a one in three chance of being randomized to receive the triple drug regimen, NAC alone, or placebo for a period of up to 60 weeks.

"We will continue to analyze the data to try to understand why this particular combination may be detrimental in people with IPF," said Fernando Martinez, M.D., professor of medicine, University of Michigan, Ann Arbor and co-chair of the PANTHER-IPF study. "The results are not explained by any differences between the two groups before the treatments started."

IPF is a progressive and currently incurable disease characterized by the buildup of fibrous scar tissue within the lungs. This accumulation of scar tissue leads to breathing difficulties, coughing, chest pain, and fatigue. Approximately 200,000 people in the United States have IPF. The cause or causes of IPF remain unknown; as a result treatment options remain limited. PANTHER-IPF began enrollment in October 2009.

The study had enrolled 238 of a planned 390 participants prior to the stop announcement. Participants ranged from 48 to 85 years of age, with an average age of 68. The placebo and NAC arms will continue enrolling and following their participants, and this part of the PANTHER-IPF study is expected to be completed by late 2013.

In addition to NIH funding, the Cowlin Family Fund at Chicago Community Trust provided financial support for this study. Zambon donated the NAC and matching placebo; the prednisone, azathioprine, and their matching placebos were purchased using study funds.

Find more information about this clinical trial at http://clinicaltrials.gov/ct2/show/NCT00650091 To arrange an interview with an NHLBI spokesperson, please contact the NHLBI Communications Office at (301) 496-4236 ornhlbi_news@nhlbi.nih.gov.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online atwww.nhlbi.nih.gov.

21 October, 2011

Prostate Cancer Risk from Vitamin E Supplements

A new study found that vitamin E, once thought to reduce the risk of prostate cancer, may actually increase the risk.

Scanning electron micrograph of a prostate cancer cell.

A prostate cancer cell. Image by Anne Weston. All rights reserved by Wellcome Images.

Prostate cancer is the second most common type of cancer in American men. Their current lifetime risk of prostate cancer is 16%. In 2011, there will be an estimated 241,000 new cases of prostate cancer and 34,000 deaths from the disease nationwide

Some early research had suggested that selenium or vitamin E might reduce the risk of developing prostate cancer. To investigate, NIH’s National Cancer Institute (NCI) and several other NIH components funded the Selenium and Vitamin E Cancer Prevention Trial (SELECT). The study began in 2001 and included over 35,000 men.

An initial report in 2008 found that regular intake of vitamin E, vitamin C or selenium does not reduce the risk of prostate cancer or other cancers in older men. The participants were told to stop taking their study supplements and, in 2010, the study sites were closed.

The SELECT researchers had seen a slight increase in prostate cancer risk with vitamin E that may have been due to chance. Over half of the study participants had consented to continue to have their health monitored via mail questionnaires. The researchers’ new analysis included this final data, which was collected through July 2011. Their report appeared on October 12, 2011, in the Journal of the American Medical Association.

The researchers found that men who took 400 international units (I.U.) of vitamin E daily had more prostate cancers than men who took a placebo. For every 1,000 men, there were 76 prostate cancers over a 7-year period among those who took vitamin E supplements vs. 65 in those taking placebo—11 more cases of prostate cancer per 1,000 men. This represents a 17% increase in prostate cancers, a difference not likely due to chance.

The researchers don’t know why vitamin E increased risk instead of decreasing it. SELECT researchers are now measuring the amount of vitamin E, selenium and other nutrients in the blood of participants when they joined the trial to see if the effect of the supplements was affected by baseline levels of these micronutrients. Other researchers are looking at single-letter DNA variations called single nucleotide polymorphisms (SNPs) to see if genetic differences affect a man’s risk of developing prostate cancer while taking vitamin E.

“Based on these results and the results of large cardiovascular studies using vitamin E, there is no reason for men in the general population to take the dose of vitamin E used in SELECT, as the supplements have shown no benefit and some very real risks,” says Dr. Eric Klein, a study co-chair at the Cleveland Clinic. “For now, men who were part of SELECT should continue to see their primary care physician or urologist and bring these results to their attention for further consideration.” 

18 October, 2011

Do Baby Products Prevent SIDS? FDA Says No

Do Baby Products Prevent SIDS? FDA Says No - (JPG)The best thing you can do to lower the chance of Sudden Infant Death Syndrome (SIDS) is to place your baby on his or her back to sleep, with nothing else in the crib or bassinet.

That’s the recommendation of the Food and Drug Administration (FDA), which is working to prevent manufacturers of over-the-counter sleep products for babies from claiming that their use will prevent or lower the chance of SIDS. These products include infant positioners, mattresses, crib bedding, pillows, crib tents and baby monitors. Baby products that claim to cure, treat or prevent any condition are considered medical devices, and are subject to FDA regulations designed to protect consumers and patients.

The agency has never approved a product to prevent SIDS—the unexplained death of a baby younger than age 1—and is asking manufacturers to stop marketing their products with these claims until they have received FDA clearance or approval, or to change their labeling to remove all medical claims.

“These products are absolutely not necessary and they can be very dangerous,” says Susan Cummins, M.D., M.P.H., chief pediatric medical officer in FDA’s Center for Devices and Radiological Health.

Dangerous comforts

FDA is aware of 13 infant deaths in the past 13 years associated with sleep positioners, which are used to keep the baby in a desired position. The Consumer Product Safety Commission has received reports of babies found in hazardous positions after being placed in a positioner.

Other products can also be hazardous. Babies can slide down and be trapped by wedges designed to keep them on their back, says Cummins. Blankets, quilts, soft toys and pillow-like crib bedding can smother, she adds.

It’s a matter of A-B-C, says Cummins:

  • Alone in their own bed. Don’t keep the infant in your bed next to you and risk that the baby will be accidentally suffocated if you roll over.
  • Back to sleep—every sleep. “The safest way to put the baby to sleep is on his or her back every time,” says Cummins. “Do not put the baby on his side or on his stomach.”
    Since the national Back to Sleep campaign in 1994 urged parents to place babies on their backs, there has been a 60 percent reduction in SIDS, Cummins says.
  • Crib. The baby should always be placed in a crib or bassinet to sleep.

Cummins describes the ideal sleep environment for an infant as being free of anything that could block the infant’s movement or breathing.  All that’s needed is a firm crib mattress and a tight-fitting sheet.

To parents who have visions of a crib filled with comforts, she says, “Though a crib full of plush toys and soft bedding may look appealing to you, it is hazardous for your baby during his or her first year of life.”

“Your baby will develop faster in that first year than any time after. Newborns can't even hold up their head, yet by their first birthday they are walking or nearly so,” says Cummins. “In between, your baby will learn to roll, sit, turn, crawl and even may start to climb!”

“So in that first year, your baby constantly and rapidly develops new skills, even in the crib during sleep time,” she says. “Make your baby’s crib a safe place to sleep and move, with nothing to get in the way.”

Safe Sleep Resources

FDA is starting a new website on SIDS prevention claims for parents, caregivers and manufacturers of sleep products for babies. Its purpose is to:

  • inform parents and caregivers about the risks associated with over-the-counter products that claim to prevent SIDS.
  • help manufacturers understand and comply with FDA laws and regulations governing medical devices, which are designed to protect consumers and patients.

The site also offers advice to parents on reducing the risk of SIDS and a list of “baby safe sleep” resources.

“The sleep environment is the one place where the baby is alone, so we want to make sure it’s safe,” says Cummins. And in this case, she says, less is more.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

17 October, 2011

Organ Donation: Pass it On Give a Gift of Life


Cartoon of a woman in a hospital bed with family wishing her well.

   A gift with a major impact—one that will long be remembered with gratitude—takes just a bit of preparation. When you become anorgan donor, you can save the lives of up to 8 people. And if you donate tissues like blood cells, bone or corneas, you can help even more.

Organ transplantation was once considered an experimental procedure with a low success rate. Many transplanted organs survived just a few days or weeks. But researchers have transformed transplant surgery from risky to routine. It’s now the treatment of choice for patients with end-stage organ disease. Each day, about 80 Americans receive a lifesaving organ transplant.

“The outcomes of transplantation are really so good these days that it truly makes a difference for the people who receive organ transplants,” says Dr. Sandy Feng, a transplant surgeon at the University of California, San Francisco. “The organs are clearly lifesaving.”

The problem now is that there aren’t enough organs to meet the demand. In early 2011, more than 110,000 people were on the nationwide waiting list for an organ. An average of nearly 20 of them dies each day while waiting.

The kidney is the most commonly transplanted organ. More than 16,000 kidney transplantations were performed in the U.S. last year. The wait, though, can be long. In February 2011, nearly 90,000 people were on the national waiting list for a kidney. Next most commonly transplanted is the liver, with more than 6,000 surgeries in 2010. That’s followed by the heart, lungs, pancreas and intestines.

You can donate some organs—like a kidney or part of your liver—while you’re still alive. You have 2 kidneys but really need only one. And the liver can re-grow if part of it is removed. But donating these organs requires major surgery, which carries risks. That’s why living donors are often family or friends of the transplant recipient.

Most organs, though, are donated after the donor has died. The organs must be recovered quickly after death to be usable. Many come from patients who’ve been hospitalized following an accident or stroke. Once all lifesaving efforts have failed and the patient is declared dead, then organ donation becomes a possibility.

“When a person dies, it can feel like a burden to a family to make decisions about organ donation,” says Feng. “So it would be a real gift to a family to indicate your decision to be an organ donor while you’re still alive, so they don’t have to make the decision for you.”

In addition to organs, you can donate tissues. One of the most commonly transplanted tissues is the cornea, the transparent covering over the eye. A transplanted cornea can restore sight to someone blinded by an accident, infection or disease. Donated skin tissue can be used as grafts for burn victims or for reconstruction after surgery. Donated bones can replace cancerous bones and help prevent amputation of an arm or leg. Donated veins can be used in cardiac bypass surgery.

NIH-funded scientists are exploring a variety of ways to improve organ transplantation. The biggest problem is that when an organ from one person is transplanted to another, the recipient’s immune system attacks the implant as though it’s a disease-causing microbe.

“We’d hit a home run if we could find a way to re-educate a person’s immune system so that it continues to fight infection just as effectively as ever but it didn’t recognize a transplanted organ as foreign. That’s called transplantation tolerance,” says Dr. Nancy Bridges, chief of the transplantation immunology branch at NIH.

To prevent organ rejection, recipients must take drugs, called immunosuppressants, usually for the rest of their lives. “Immunosuppressant drugs have revolutionized our ability to do organ transplantation over the last 30 years,” says Dr. Jerry Nepom, who heads an NIH-funded program called the Immune Tolerance Network. “But those 3 decades have also taught us that these immunosuppressants are not very selective, which is a big problem.”

Immunosuppressants knock down the entire immune system, so that the body has trouble fighting off infections. The drugs also boost the risk for cancer, especially skin cancer. In addition, over time, these potent drugs can damage the kidneys and raise the risk for diabetes, high blood pressure and cardiovascular disease.

“These medications are sort of a necessary evil. You can’t live without them, because you might reject your organ. But it’s difficult to live with them because they cause side effects that need to be managed,” says Feng.

If a patient stops taking immunosuppressants, the transplanted organ nearly always fails. But in very rare cases, people can go off their medications. Last year, NIH-funded scientists spotted a pattern of gene activity in patients who had successfully stopped taking their immunosuppressants after a kidney transplant. Other researchers are testing whether certain liver transplant patients could be weaned off their medications.

“Ultimately, it would be valuable if we could do a blood test to predict who could stop taking their drugs or maybe be on a lower dose,” says Bridges. “We have evidence that it might be possible, but we’re not there yet.”

In other studies, Nepom says, “we’re exploring how to get the recipient’s immune system in a receptive mode, so that it doesn’t become excited and angry when a transplanted organ comes into the body.” In one small clinical study, researchers gave a kidney recipient some of the donor’s bone marrow before surgery. Bone marrow produces cells that fight infection. The procedure created a hybrid immune system in the recipients that better tolerated the transplants. A few patients were able to go off their immunosuppressants within a year after surgery.

While some scientists continue to improve current methods, others are exploring completely new ideas. One cutting-edge approach is to create artificial transplants that won’t trigger an immune system attack. Although years of research will be needed to apply these emerging techniques, researchers have made progress toward engineering livers, lungs and other organs.

You can help reduce the need for donated organs in the first place by living well. Lower your risk of developing a long-term disease that could lead to organ failure by being physically active and eating a healthy diet rich with high-fiber foods, fruits and vegetables. Talk to your doctor about your weight, blood pressure and cholesterol. And while you’re taking these healthy steps, be sure to sign up to be an organ donor so you can help others as well. 

Recognizing Schizophrenia Seeking Clues to a Difficult Disorder

Cartoon of a man sitting in a chair with his chin on his hands.

       What would it be like to hear voices or see people or things that aren’t really there? How would you feel if people seemed out to harm you, and you weren’t sure who to trust? Would you recognize that something was wrong?

Unfortunately, most people with schizophrenia are unaware that their symptoms are warning signs of a mental disorder. Their lives may be unraveling, yet they may believe that their experiences are normal. Or they may feel that they’re blessed or cursed with special insights that others can’t see.

Schizophrenia is a brain disorder that affects about 1 in 100 people. It affects men and women equally in all ethnic groups. Symptoms often start between ages 16 and 30 but most often between 18 and 22. It’s unusual to develop schizophrenia after age 45.

A few decades ago, researchers thought that schizophrenia was caused by inappropriate parenting. Now scientists recognize that a combination of genes and the environment are to blame.

“We know from studies of identical twins that when one twin has schizophrenia, the other twin has a 50% chance of having the disease, indicating that genes may account for half of the mechanisms involved in schizophrenia,” says Dr. José A. Apud, clinical director of the schizophrenia research program at NIH.

But since these twins are genetically the same, other factors must also contribute to schizophrenia. Some scientists have identified environmental factors that may play a role. But researchers don’t yet fully agree on whether or how these factors trigger the disease.

Several genes have been linked to schizophrenia. But each seems to have only a small effect on the chances of getting the disorder. “If we could understand the genes and mechanisms, we might be able to develop drugs that better target the disease,” says Apud.

Although schizophrenia has no cure, 2 main types of treatment can help. “The first line of treatment is always medication, especially antipsychotics,” says Apud. “Second, we use supportive types of psychotherapy and psychosocial treatments.” These can help with everyday living skills and possibly finding an appropriate job.

Patients often try different medications to see which work best. Some types of antipsychotics can cause weight gain, which can lead to diabetes or high cholesterol. Other types can cause a disorder where a person cannot control muscle movements. Despite these drawbacks, antipsychotics greatly improve the lives of most patients.

Problems arise when patients stop taking their medications, which is common. One NIH-funded study found that most patients stop taking antipsychotics within the first 18 months of treatment. “Because of problems with judgment and insight, they may not feel that they need treatment,” Apud says. “Side effects also play a major role in patients’ poor compliance with medications.”

People with schizophrenia often must rely on family or friends to get them into treatment. Caring for and supporting a family member with schizophrenia can be challenging. It may help to find a support group. Talking to others who care for people with schizophrenia may help your whole family.

16 October, 2011

Genes that Influence Blood Pressure

 

In one of the largest genomic studies ever, an international research consortium identified 29 genetic variations that influence blood pressure. More than half of these variants were previously unknown. The findings provide insights into the biology of blood pressure and may lead to new therapeutic strategies.

 

High blood pressure, or hypertension, affects over 1 billion people worldwide.

Photo of a blood pressure gauge

  It can damage the body in many ways over time, leading to heart  disease,        stroke, kidney failure and other health problems.

More than 230 researchers across 6 continents scanned the genomes of over 200,000 European people to identify genetic variants that influence systolic and diastolic blood pressure. They followed up by analyzing the genomes of 70,000 people of East Indian, South Asian and African ancestry. The study was funded by NIH’s National Heart, Lung and Blood Institute (NHLBI), National Institute on Aging (NIA) and National Human Genome Research Institute (NHGRI), among others. The results appeared in the September 11, 2011, issue of Nature.

The researchers discovered 16 previously unknown variations. Six were found in genes already suspected of regulating blood pressure. The remaining 10 were found in unexpected locations and provide new clues into how blood pressure is controlled. Individually, the genetic variations increased the risk of hypertension by only a tiny amount. However, for people with multiple variants, the effects were significant.

The researchers developed a blood pressure genetic risk score based on the 29 variants they found. Among people with the top 10% of genetic risk score, 29% had hypertension, compared with 16% of those in the lowest risk group. Higher genetic risk scores were associated with increased blood pressure across ethnic groups. The risk score was also a good indicator of hypertension complications, such as increased thickness of the heart chambers, heart failure, stroke and coronary artery disease.

“This is one of the most important studies of the genetics of high blood pressure to date and a significant step toward finding better therapies for it,” says NHLBI Acting Director Dr. Susan B. Shurin.

A related study by the research group, the International Consortium of Blood Pressure Genome-Wide Association Studies, appeared on the same day in Nature Genetics. This other genome-wide association study identified 4 new genetic regions associated with pulse pressure and 2 linked to mean arterial pressure. The influence of these variants on systolic and diastolic blood pressure turned out to be more complex than expected.

Taken together, these findings suggest new genetic pathways underlying blood pressure regulation. They will also likely open new doors to research into treating high blood pressure.

Community Immunity


How Vaccines Protect Us All

Cartoon of boy looking at a Band-Aid on his vaccinated arm.

Parents know that kids are vulnerable to a host of infectious diseases. Research supported by NIH and others proves that the benefits of vaccines in preventing illness and death greatly outweigh the risks.

The list of childhood diseases can be overwhelming: measles, mumps, rubella, diphtheria, pertussis, polio, meningitis, influenza and rotavirus. In the era before vaccines, many children in the U.S. died or became disabled from these diseases. Many still do in countries and regions with lower vaccination rates.

With all the international travel in the world these days, it’s important to keep vaccines, or immunizations, up to date. Here’s just one example of what might happen if you don’t. By 2000, immunization had practically wiped out measles in the U.S. But a measles outbreak in 2005 was traced to one unvaccinated U.S. resident infected during a visit to Europe. The returning traveler infected American children who hadn’t been vaccinated because of safety concerns—despite study after study showing that childhood vaccines are safe and effective.

A major epidemic didn’t emerge that time. That’s because enough people in the surrounding communities had already been vaccinated against measles.

“The important concept,” says Dr. Marc Lipsitch of the Harvard School of Public Health, “is that vaccinating people protects not only them, but others in the community. If I’m protected, I can protect others.”

This type of protection is known as “community immunity” or “herd immunity.”  When enough of the community is immunized against a contagious disease, most other members are protected from infection because there’s little opportunity for the disease to spread.

Newborns, pregnant women or people whose immune systems are weakened may not be eligible for certain vaccines. Yet even they will get some protection because the spread of contagious disease is contained.

“Epidemiologists think of infections as chain reactions, whose speed depends on contagiousness,” says Lipsitch. “The more contagious the disease, the more vaccination is required. The data tells us that herd immunity works.”

Using mathematical formulas and computer programs, NIH-funded scientists like Lipsitch have developed models to determine what proportion of the population has to be vaccinated to eliminate the spread of disease. As one example, a worldwide vaccination campaign completely eliminated, or eradicated, smallpox in the 1970s. So many people were immunized that the virus couldn’t sustain itself.

More recently, infant vaccination against Haemophilus influenzae type b (Hib, which can cause meningitis) lowered the risk of disease in the whole population. Before the vaccine, Hib struck about 1 in 200 children younger than age 5. It killed many and often left survivors with permanent brain damage. After the Hib vaccine was introduced in the mid-1980s, the incidence of Hib dropped by 99%.

“Infectious disease eradication is possible,” says Lipsitch. Even when a disease—such as measles or Hib— hasn’t been completely wiped out, immunizations can reduce disease transmission, so that epidemics become less frequent.

When parents choose to immunize, they’re helping more than their own. Make sure your child’s immunizations are up to date. And talk with your child’s doctor if you have any concerns about vaccine safety.

Inefficient developing world stoves contribute to 2 million deaths a year

 

International effort could reduce death toll, deforestation, NIH scientists say

An international effort to replace smoky, inefficient household stoves that people commonly use in lower and middle income countries with clean, affordable, fuel efficient stoves could save nearly 2 million lives each year, according to experts from the National Institutes of Health.

In a commentary in Science, the NIH scientists noted that indoor air pollution from such inefficient stoves affects about 3 billion people—nearly half the world's population. In addition to respiratory disease caused by smoke, the fuel needed by inefficient stoves leads to—deforestation, and environmental degradation.

"Many people in developed countries don't realize that smoke from indoor cooking fires is a terrible scourge upon the health of a large number of people," said Francis Collins, M.D., Ph.D, director of the National Institutes of Health and an author of the study. "International efforts to combat this scourge are now beginning. The NIH's role is to support the research that will determine the most efficient, cost effective means to do so while safe guarding human health."

The study authors stated that nearly half the world's population uses biomass (wood, crop residues, charcoal or dung) or coal as fuel for cooking and heating. "The primitive fires typically fill homes with dense smoke, blackening walls and ceilings and sickening those within."

Other authors of the study were William J. Martin II, M.D., associate director for prevention research and health promotion at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Roger I. Glass, M.D., Ph.D., director of the Fogarty International Center, and John M. Balbus, senior advisor for public health, National Institute of Environmental Health Sciences.

Women and children are at greatest risk for the adverse health effects posed by inefficient stoves, the study authors wrote. Men tend to leave home during the day, but women and children remain. As a result, women and children have many of the same disease risks as do people who smoke tobacco. These risks include pneumonia, lung cancer and chronic obstructive pulmonary disease.

In many societies, women and girls typically gather fuel for the stoves. Fuel gathering is time-consuming and, because they must often walk several miles from the safety of their home communities, these women and girls are at increased risk for gender-based violence.

"By freeing up time, efficient stoves can even expand the opportunities for education and economic development of women and girls in these impoverished areas," the scientists wrote.

The study authors cited a recent report by the World Bank, which noted that, in addition to improving public health, clean, efficient stoves could have benefits to the environment and the climate, by reducing carbon dioxide emissions.

In recognition of the problem, the United Nations launched the Global Alliance for Clean Cookstoves. A public-private partnership, the alliance seeks to create a global market for clean and efficient cookstoves and fuels in the developing world. The alliance’s target is "100 by 20," which stands for the adoption of clean, efficient stoves and fuels by 100 million homes by the year 2020, with eventual worldwide adoption. The authors noted that the U.S. government has committed more than $50 million to the effort, including about $25 million in research funds for the NIH.

To succeed, strategies for replacing the world's inefficient biomass stoves with clean, efficient stoves must be market driven, the researchers added. So that cleaner stoves will be accepted, they must meet the needs of those who will use them.

"Promoting sustained changes in the way food is cooked to reduce [indoor air pollution] requires a fundamental understanding of traditions, social interactions, and family dynamics, which differ widely across cultures," the authors wrote. "Successful implementation invariably involves women in stove design, training, use in the home, and follow-up in the community."

Local manufacture of new stoves would have the added benefit of stimulating local economic development.

Educating people about the health risks of the stoves would also increase demand, as potential users understand that the initial expense of a more efficient stove would have health benefits in the long run, the authors wrote. Governmental subsidies to help the poorest people purchase the stoves would provide additional incentive, as would efforts to informal local peoples that the new stoves would cut household fuel costs.

The authors also called for more research on the potential health benefits of cleaner, more efficient stoves. It is not precisely known how much emissions must be reduced to produce health benefits. For example, preliminary data from one study suggest that reducing exposure to emissions by 90 percent is needed to substantially reduce the risk of pneumonia, and reducing exposure by 50 percent is required to modestly reduce the risk. Similarly, such studies could confirm the link between indoor air pollution and suspected health risks such as low birth weight, cataracts, cardiovascular disease, asthma, and tuberculosis.

The authors noted, however, that programs to replace inefficient stoves are already under way and that these programs have been undertaken without advance research into their potential benefits. Along with research to determine the amount of reduction in indoor air pollution needed to be effective, programs are also needed to evaluate the potential benefits of programs now under way.

The authors estimated the costs of a research program to on health and indoor air pollution to range from $150 million to $200 million. Although these costs might seem high, the authors wrote, they are typical of the costs of research investments needed to combat leading worldwide causes of death.

"The challenges are great, but the potential to use a relatively low cost intervention to save millions of lives, improve the environment, and encourage economic development is compelling," the researchers concluded.

Fogarty, the international component of the NIH, addresses global health challenges through innovative and collaborative research and training programs and supports and advances the NIH mission through international partnerships. For more information, visit: www.fic.nih.gov.

The National Institute of Environmental Health Sciences supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, visit our Web site at http://www.niehs.nih.gov.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute's Web site athttp://www.nichd.nih.gov/.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.

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