FDA Panel Backs New Device for Chronic Heartburn

An implantable device to treat chronic, severe acid reflux disease has moved one step closer to approval. An FDA advisory committee unanimously voted that the LINX device was safe and effective for treating chronic gastroesophageal reflux disease, or GERD, that does not respond to medication.

The panel also unanimously voted that the benefits of LINX for those patients outweigh the risks. The FDA usually, but not always, follows its advisory committees’ guidance.

The LINX device is a titanium ring of magnetic beads. It’s placed around the lower end of the esophagus to strengthen the sphincter, or ring of muscle, that’s supposed to prevent acid and other stomach contents from rising. At the same time, it is said to be pliant enough to allow food and liquids to enter the stomach.

Manufactured by Torax Medical of Shoreview, Minn., LINX has been on the market in the United Kingdom, Germany, and Italy for about two years, according to Todd Berg, the company’s president and CEO.

About 19 million U.S. adults suffer from GERD, FDA medical officer Priya Venkataraman-Rao, MD, told the panel. Doctors recommend treating it first with nonsurgical methods, such as raising the head of the bed, losing weight, eating smaller meals, or taking antacids or other medications called H2 blockers or proton-pump inhibitors.  

If none of those work, the main alternative is a surgical procedure in which the top part of the stomach is cut and wrapped around the esophagus.

Torax implanted 100 patients with LINX in its pivotal clinical trial. On average, they’d suffered from GERD for 13 years and experienced about 80 episodes of heartburn a week. People with a BMI greater than 35, a large hiatal hernia (when the stomach bulges into the chest through an opening in the diaphragm), a history of trouble swallowing (more than once a week for the previous three months), a severely inflamed esophagus, or Barrett’s esophagus -- in which the lining of the esophagus, damaged by acid, becomes more like the lining of the intestine -- were excluded from the study.

The acid level in the patients’ esophagus was assessed before and 12 months after LINX was implanted via minimally invasive “keyhole” surgery. Just over half of the patients saw their acid level fall by at least one-half. 

Improvement on a subjective quality-of-life assessment -- which asked such questions as when and how often heartburn occurred and whether it kept them up at night -- was even greater, both at 12 months and 24 months after surgery, Venkataraman-Rao said.

But because the study did not have a comparison group that did not get the device, there’s “no way of knowing whether subjects would have improved on their own,” Venkataraman-Rao said.

How to Wreck Your Heart

What not to do for your heart's health.

When it comes to the heart’s health, there are some things you can’t control -- like getting older, or having a parent with heart disease. But there are many more things you can do to lower the chances of sabotaging your ticker.

“An ounce of prevention really is worth a pound of cure in this instance,” says Gregg Fonarow, MD, an American Heart Association spokesman and associate chief of UCLA's division of cardiology.

To help your heart keep on keeping on, here are 10 things not to do.

A major cause of heart disease, smoking raises blood pressure, causes blood clots, and makes it harder to exercise. And it’s the number one preventable cause of premature death in the U.S., according to the American Heart Association.

Even though it may be one of the most difficult habits to quit, the rewards of stopping smoking are perhaps the greatest and most immediate.

When you toss the smokes, your heart risk goes down within just a few days of quitting. Within a year, your risk is cut by half. After 10 years of living smoke-free, it’s as if you never smoked at all, says Nieca Goldberg, MD, cardiologist and medical director of the New York University Women’s Heart Program.

When your heart literally aches and you don’t know why, it’s time to get checked out.

If you have chest pains while exercising, that’s a red flag. But if it happens after a heavy meal, it’s more likely to be your stomach causing trouble, says Goldberg, who is an American Heart Association spokeswoman and author of Dr. Nieca Goldberg’s Complete Guide to Women’s Health.

Heart pain can feel more like a pressure rather than actual pain. People tend to feel it in the front of their chest, with the sensation sometimes extending into the shoulders, up into the jaw, or down the left arm. If you feel like an elephant is sitting on your chest and you’re breaking out in a sweat, that’s an urgent matter. Call 911.

Regardless of what you’re feeling or when, even a doctor can’t tell if you’re in real trouble over the phone. So you have to seek medical attention in person to get a definitive answer for chest pain.

Having a family history of heart disease is a strong risk factor for predicting your own chances of heart trouble.

Having a parent who has had an early heart attack doubles the risk for men having one; in women the risk goes up by about 70%, according to an American Heart Association report from December 2010.

Is Your Teen's Bedroom a Health Hazard?

Unless your kid is using his room to harbor wild animals or make explosives, it's probably not a true health hazard. But it might get plenty yucky in there.

Could your teen's bedroom be a health hazard? With the piles of crusty socks, the old cereal bowls of curdled milk, and the mildewed towels, it certainly might look -- and smell -- that way.

Happily, as disgusting as your teen's messy room might be, it's unlikely to pose any serious health risks. "I've never seen any teenager who actually got sick because her room was unsanitary," says Tanya Remer Altmann, MD,a pediatrician and author of Mommy Calls and The Wonder Years.

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Of course, whether or not your teen's messy room meets the Department of Health's legal definition of a health hazard isn't really the issue. If your teen's bedroom is disgusting, and it bothers you, you need to do something about it.

"Teenagers need to learn how to look after themselves, and cleaning their rooms is part of that," says Charles Wibbelsman, MD, chairman of the Chiefs of Adolescent Medicine for Kaiser Permanente of Northern California and co-author of The Teenage Body Book. It's a basic responsibility and a skill they'll need as adults, he says.

So how can you get your teen to keep his or her room clean, or at least somewhat less disgusting? Here's some advice from the experts.

Unless your kid is using his room to harbor wild animals or make explosives, he's probably not created a genuine health hazard. But it still might get plenty yucky.

"If you can smell your teen's room down the hall -- because of old food or old laundry -- that's not sanitary," Altmann tells WebMD. "And it could even conceivably pose some health problems." Like what?

Mold. Depending on the weather, it won't take long for mold to start growing on a half-eaten sandwich. Large amounts of mold could actually affect the air quality and aggravate a person's allergies or asthma.Insects and other pests. As you've no doubt already said to your teen a thousand times, dirty dishes attract insects -- like ants and cockroaches -- as well as other pests like mice and rats. Dust mites can thrive in clutter. Finding any of these creatures in your house is disgusting. But some can carry disease as well as trigger allergies and asthma, Altmann says.Bacteria and other fungi. Some nasty things can grow on unwashed, damp clothing in a messy room. And if your teen keeps wearing the clothes pulled off the floor rather than out of the bureau, he could develop rashes and other problems -- like jock itch, which is caused by a fungus.

While you may be horrified by the revolting things that you discover in your teen's bedroom, you may still feel powerless to do anything about them. Asking, pleading, and screaming don't seem to work. So how should a parent handle it?

IVF: Are 3 Embryos Too Many to Transfer?

Transferring more than two embryos during an IVF cycle is a dangerous practice that does not improve a woman’s chances of delivering a baby, a European study finds.

Researchers analyzed close to 125,000 in vitro fertilization (IVF) cycles performed in the U.K. over a five-year period in one of the largest studies ever to compare outcomes in women younger than 40 to those of older women.

The conclusion that there is no medical justification for transferring three or more embryos, even in women over the age of 40, has major implications in the U.S., where 1 in 3 IVF procedures involves the transfer of more than two embryos.

While that represents a decline from a decade ago, when closer to 2 out of 3 IVF procedures in the U.S. involved three or more embryos, there is still plenty of room for improvement, a study co-author says.

“The practice of transferring multiple embryos is very much market-driven in the United States,” says Scott M. Nelson, MD, PhD, of the University of Glasgow Centre for Population and Health Sciences. “There is an economic incentive for transferring more embryos in the U.S., but no sound medical reason for doing so.”

New York infertility specialist Glenn L. Schattman, MD, disagrees. Schattman is president of the Society for Assisted Reproductive Technology (SART).

SART guidelines call for the transfer of one or two embryos per IVF cycle in younger patients with the best prognosis, and as many as four embryos per cycle in patients in their late 30s and 40s with a poor chance of achieving a pregnancy.

He says it is clear from SART’s own statistics that the poorest-prognosis patients have a much better chance of having a baby when more than two embryos are transferred.

“There is a continuous and constant decline in fertility with increasing age, so it makes no sense to treat a 39- or 40-year-old the same way we would a 26-year-old,” he says.

The 124,148 IVF cycles analyzed by Nelson and colleague Debbie A. Lawlor, PhD, of the University of Bristol, resulted in 33,514 live births.

The live birth rate was greater with the transfer of two embryos, compared to one, in women under the age of 40 and in women who were older. Transferring three embryos resulted in a lower birth rate than transferring two in the younger women and made no difference in outcomes in older women.

Compared to single-embryo transfer, transferring two or three embryos was associated with a higher risk for all adverse birth outcomes, including low birth weight and preterm delivery.

Not surprisingly, the overall live birth rate was lower in older women compared to younger ones, no matter how many embryos were transferred.

“A clear implication of our study is that [the] transfer of three embryos should no longer be supported in women of any age,” Nelson and Lawlor write.

Juicing: How Healthy Is it?

What to know before adding fresh juice to your diet.

Juicing is popular. But before you give it a whirl, you might want to know what it may -- and may not -- do for your health.

What are the nutritional benefits and drawbacks? Can you juice for weight loss? What about food safety and claims about cleansing your system? Here's what you need to know.

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Jennifer Barr, a Wilmington, Del., dietitian, often makes fresh juice as a snack for her kids. Her favorite juice combines kale, carrots, ginger, parsley, and apples. She then adds the leftover pulp from her juicing machine into muffins.

“If you’re not big into fruits and vegetables, it’s a good way to get them in. It can help you meet daily recommendations in one drink” and be part of a healthy diet, says Barr, MPH, RD, LDN, who works at Wilmington's Center for Community Health at Christiana Care Health System.

But you shouldn't count on juicing as your sole source of fruits and vegetables.

"Don’t think because you’re juicing that you’re off the hook with eating fruits and vegetables,” says Manuel Villacorta, MS, RD, CSSD, an Academy of Nutrition and Dietetics spokesman and founder of Eating Free, a weight management program.

Aim to eat two whole fruits, and three to four vegetables a day. They should come in different colors, as the colors have different vitamins and minerals, Barr says.

A juicing machine extracts the juice from whole fruits or vegetables. The processing results in fewer vitamins and minerals, because the nutrient-rich skin is left behind. Juicing also removes the pulp, which contains fiber.

You can add some of the leftover pulp back into the juice or use it in cooking.

Besides muffins, Barr uses other combinations -- such as spinach, pears, flaxseed, celery, and kale -- to make broth for cooking soup, rice, and pasta. She calls it "going the extra step to fortify your meals."

Juicers can be expensive, ranging from $50 to $400. Some more expensive juicers will break down a lot of the fruit by grinding the core, rind, and seeds, Barr says.

You may not need a juicing machine to make juice. You can use a blender for most whole fruits or vegetables to keep the fiber -- add water if it becomes too thick, Villacorta says.

You’ll also want to remove seeds and rinds, and some skins.

Psoriatic Arthritis: Caring for Skin and Joints

If you've been diagnosed with psoriasis, it's important to be on the lookout for painful or swollen joints in your body that could indicate the development of psoriatic arthritis.

About 30% of people with psoriasis develop psoriatic arthritis symptoms, usually when they are between 30 and 50 years of age. Psoriatic skin lesions usually occur before the onset of arthritis. Early detection and receiving prompt psoriatic arthritis treatment are essential. Untreated psoriatic arthritis can result in permanent, crippling joint damage.

Since most people with psoriatic arthritis also have psoriatic skin lesions, it's important to balance treatment for your skin and joints. The good news is there are a variety of psoriatic arthritis treatments, including lifestyle habits and medications. Many are effective against psoriasis and psoriatic arthritis, meaning the same therapies can benefit your joints and your skin.

"At the moment, the key thing is awareness among patients with psoriasis and dermatologists who treat psoriasis to help prevent the progressive damage that can occur with psoriatic arthritis," says Seattle-based rheumatologist Philip Mease, MD.

Researchers don't know what causes some people with psoriasis to develop psoriatic arthritis. Evidence suggests that a combination of genetics and the environment can trigger an autoimmune response in which the body attacks its own tissues. That autoimmune response causes psoriatic arthritis symptoms, such as inflammation in the joints.

If you have psoriasis, you could be at risk of developing a variety of different forms of psoriatic arthritis, each of which can vary in severity among individuals and within a given person over a period of time. Psoriatic arthritis can be symmetric, meaning it occurs in the same joints on both sides of the body. But it is more often asymmetric, meaning it may affect the fingers of your left hand and toes of your right foot, for example.

For many people, the symptoms of psoriatic arthritis include swelling of the fingers and toes. They may take on a characteristic sausage shape, which is called dactylitis. If psoriatic arthritis affects the joints of your toes and fingers, it is most likely to strike the ones closest to the nail. Psoriatic arthritis can cause your nails to develop pits or peel away from the nail bed. In contrast, rheumatoid arthritis (RA) -- another autoimmune disease -- is more likely to affect the toe and finger joints closest to the hand or foot.

At times, psoriatic arthritis symptoms can cause your joints to be painful and stiff even when there is no swelling. In some instances, psoriatic arthritis leads to arthritis of the spine, known as spondylitis. In rare cases, it can lead to a disfiguring condition in the hands and feet called arthritis mutilans.

Regardless of which joints are affected by psoriatic arthritis, you may find you have morning stiffness and fatigue.