Senate Committee to Examine FDA's Medical Device Approval Process

Comstock/Thinkstock(WASHINGTON) -- Katie Korgaokar was 36 years old when she underwent an agonizing operation to have hip replaced because of Perthes disease -- a condition that blocked blood supply to her femur during childhood. Little did she know the procedure was just a warm-up for what was to come.

"They had this new, latest greatest hip out there that was going to be perfect for a woman that was smaller," said Korgaokar, who initially hesitated to sign up for such a major procedure. "So I said, whatever you think is best is what we're going to do."

After getting her new hip in November 2006, Korgaokar could hike, ski and ride horses around her Denver home free of pain.

"I wish I'd done it much earlier, because it completely changed my life," said Korgaokar.

But her life soon changed again, when she received a letter last fall stating that her hip was being "voluntarily recalled."

"I thought: that's what happens to cars," Korgaokar said. "It just really seemed like a joke -- you don't recall parts you put in a person."
It was no joke. Korgaokar's hip was being recalled because of a design flaw that her doctor said could leech chromium and cobalt into her body.

"You put your faith in the doctor and the companies that make these products because they're the experts," Korgaokar said. "It's just beyond me to think that things can get approved that really don't work. It leaves me speechless."

A U.S. Senate Special Committee on Aging will Wednesday hold a hearing to examine the Food and Drug Administration's medical device approval process. Korgaokar will testify alongside six medical device experts.

Investigations by FDA officials and outside researchers have revealed troubling lapses that have led to device recalls -- sometimes requiring surgery.

A February study published in the Archives of Internal Medicine suggested most medical devices recalled for life-threatening or serious hazards were cleared by the FDA through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely.

"In my view, the regulatory system is failing," said Dr. Steven Nissen, a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen and colleagues examined the number of medical device recalls from 2005 to 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous pre-market approval process. Of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k), and eight were exempt from FDA regulation.

"Some 80 percent or so of devices being recalled were actually never fully clinically tested in people," Nissen said.

Copyright 2011 ABC News Radio


Pica Eating Disorder: Florida Mom Eats Sofa Cushions Like Candy

Jupiterimages/Thinkstock(BRADENTON, Fla.) -- Adele Edwards has an unusual eating disorder: she consumes couches like they were candy, going through seven sofas in the last 21 years.

The Bradenton, Florida mother-of-five has a condition called pica, which more often affects young children and pregnant mothers.  Her non-food item of choice is the foam inside the cushions.

"I unzip the cushions and snack on the foam inside," Edwards. 31, told Britain's Daily Mail newspaper.  "And once I start I just can't stop.  But now doctors have told me that if I carry on, my addiction will kill me."

Edwards said she chomps down a throw pillow each week -- reaching for the foam about 15 times a day.  She said her craving for foam becomes worse when she is stressed.  She added that she likes the flavor and texture and sometimes rubs it in dirt before eating the foam.

Pica is a pattern of eating non-food materials, such as dirt or paper, and is seen more frequently in young children, according to the National Institutes of Health (NIH).  An estimated 10 to 32 percent of children aged 1 to 6 have these behaviors.  The name pica means "magpie" -- Latin for the bird who will eat anything.

In adulthood, these unusual cravings can be triggered by lack of certain nutrients, such as iron or zinc.

To fit the diagnosis of pica, the patient must have ingested non-food materials for at least a month.

Treatment for the eating disorder includes first addressing missing nutrients or exposure to toxins like lead.  Then, specialists address behavioral and family issues.  Mild aversion therapy followed by positive reinforcement for eating proper foods can also be successful.

Complications can include bezoar, a mass of indigestible material that is lodged in the stomach or digestive tract or an intestinal obstruction and sometimes lead poisoning or malnutrition.

Copyright 2011 ABC News Radio


Study: No Symptoms of Herpes Does Not Mean No Risk to Others

Stockbyte/Thinkstock(SEATTLE) -- Genital herpes remains one of the most common sexually transmitted diseases.  Many people think they can only infect their sexual partners if they are showing symptoms, such as genital lesions. A new study finds that among those who test positive but have no clinical symptoms, the infection is still active and can be shedding in the genital tract, therefore posing a potentially increased risk of transmitting the infection to sexual partners. 

This was the first study to look over time at people that have HSV-2 infection but don't have a history of genital herpes.

Doctors Anna Wald and Christine Johnston from the University of Washington in Seattle and co-authors studied almost 500 people, some with recurring genital herpes with  symptoms and others testing positive for the HSV-2 antibody having no clinical signs of genital herpes. All were asked to swab the genital area for at least 30 days to assess how often the virus was active.

The study appears in a theme issue on infectious diseases and immunological disorders in this week's JAMA, Journal of the American Medical Association.

Researchers also found people who had recurring genital herpes had the active virus on about 20 percent of days. 

Copyright 2011 ABC News Radio


Smartphone App Might Make Food Less Appetizing

Jupiterimages/Thinkstock(NEW YORK) -- Do you really need an app to tell you that certain foods are chock full of calories?

DailyBurn, a fitness social network, thinks you do.  That’s why the company has come up with the MealSnap smarthone app, which informs users of the calorie content of virtually everything they consume.

For instance, let’s say you’re staring at a slice of greasy, double-cheese pizza.  Just snap a photo of the meal in front of you and wait a couple of minutes while the MealSnap matches the picture with half-a-million food items in its data base.

Of course, the pizza might be cold by the time the search is over but you'll have an accurate idea of just how many calories it contains, not to mention fat, carbs and vitamins.

Furthermore, DailyBurn CEO Andy Smith says, “Users can then choose to share what they've eaten on Twitter or FourSquare, leading to social accountability.”

While Smith admits the process can be somewhat time consuming, it allows you to keep a food diary and may spur a psychological change that could get you and your online pals eating better.

Copyright 2011 ABC News Radio


Terry Bradshaw Admits NFL Concussions Cost Him

Evan Agostini/Getty Images(NEW YORK) -- Former Pittsburgh Steelers quarterback Terry Bradshaw has often joked that he's not the brightest bulb on the Christmas tree.

However, Bradshaw, a Fox football broadcaster, is dead serious these days about the side-effects of the concussions he endured during his Hall of Fame career.

Bradshaw is now saying that all those hits to the brain have resulted in short-term memory loss and diminishing hand-eye coordination.

To the best of his knowledge, the 62-year-old Bradshaw suffered six diagnosed concussions during his 14 years in the NFL.  However, he estimates that there were numerous other occasions when he had to "clear the cobwebs" after getting slammed in the head.

While the NFL is paying closer attention to concussions, Bradshaw is urging the league to bolster its support for former players who are afflicted with the effects of brain injuries.

Copyright 2011 ABC News Radio


Chocolate Milk Debate Rages in Schools

Bananastock/Thinkstock(NEW YORK) -- Chocolate milk, that sweet childhood pleasure, has become the center of an intense health debate. Some health experts believe it contributes to childhood obesity, leading many school districts to place limits on its sale or ban it outright. But many doctors and nutritionists say leaving it off the menu deprives children of valuable nutrients they aren't likely to make up elsewhere. Parents are left wondering whether it's okay for their kids to drink it or not.

Milk consumption has plummeted from 25 to 20 gallons per year per person since 1990, even as the U.S. Food and Drug Administration reports that most kids don't get enough calcium and several other "shortfall" nutrients milk offers in abundance. Increasingly, children tend to drink the majority of their milk at school and increasingly, the majority of the milk they drink is flavored -- more than 70 percent of it, according to the Milk Processor Education Program, the dairy industry's advocacy group.

Therein lies the dilemma: Provide kids with essential nutrients lacking in their diet, or limit their access to sugary, high-calorie foods?

"Flavored milk is far less sugary and tends to have fewer calories and more nutrition than beverages like soda," said Keith Ayoob, associate clinical professor in the Department of Pediatrics at the Albert Einstein School of Medicine in New York City. "Children who drink flavored milk are no more likely to be overweight and are more likely to get enough calcium and eat a better diet than kids who don't."

There is support to this claim. A survey of 58 elementary and secondary schools across the country that removed the chocolate version of moo juice from cafeterias for two years and offered only the white version found a 32-to-64-percent drop in the amount kids drank depending on the grade, in part because they stopped fully draining the carton.

"That isn't even the whole story either. Kids will simply hold their thirst until after school and head to the nearest corner store to order something that is a far worse choice. Better to give them the chocolate milk," Ayoob said.

But not everyone agrees.

"This is like asking your kids to eat more apples by giving them apple pie," said Ann Cooper, a leading advocate for healthy school lunches. "Chocolate milk is just sugary soda in drag."

While complete school bans are on the increase, some have yielded to pressure from students, parents and special interest groups and settled on a compromise of sorts. They've ordered reformulated the beverages that are lower in fat and calories and that replace high fructose corn syrup with sugars made from sucrose or beets.

Compared to typical half pint of chocolate milk which has 170 calories, 28 grams of sugar and one percent fat, the new kind has just 130 calories, 22 grams of sugar and almost no fat. A 20-ounce bottle of cola has 150 calories and 40 grams of sugar.

Copyright 2011 ABC News Radio


Could Wrist Size Predict Future Diabetes?

Jupiterimages/Thinkstock(WASHINGTON) -- Predicting an overweight child's risk of diabetes and heart disease may be as simple as measuring the size of his or her wrist, according to new research published by the American Heart Association. In the study, published in the latest addition of the journal Circulation, wrist size was linked to insulin resistance, a precursor for type 2 diabetes, in overweight kids and teens.

"This is the first evidence that wrist circumference is highly correlated to evidence of insulin resistance," Dr. Raffaella Buzzetti, senior study author and professor in the Department of Clinical Sciences at Sapienza University of Rome, Italy, said in a statement. "Wrist circumference is easily measured and if our work is confirmed by future studies, wrist circumference could someday be used to predict insulin resistance and cardiovascular disease risk."

Though measuring body fat is usually a reliable predictor of insulin resistance and heart disease risk in adults, this is not always the case for kids because their bodies grow and change so rapidly during puberty. Typically, doctors will measure a teen's BMI (body mass index) by comparing height and weight. This may be a misleading gauge, however, especially for athletes who may have a high percentage of muscle, which weighs more than fat.

In the study, researchers analyzed how wrist size and BMI correlated with levels of insulin resistance. While BMI only accounted for 1 percent of variation in insulin resistance, the wrist measurement accounted for between 12 and 17 percent.

Insulin resistance occurs when the body has difficulty using the insulin it makes to break down blood sugar. Excess body fat is linked to developing insulin resistance, and insulin resistance has been identified as a major risk factor for developing cardiovascular disease and type 2 diabetes later in life.

Surprisingly, researchers found that it wasn't necessarily a fatter wrist that correlated with higher heart disease risk, just a larger one. Because higher insulin levels in kids can contribute to increased bone production, larger wrist bones may be a marker of insulin resistance, which in turn is a predictor of future heart disease.

"It's surprising that bone size correlated better [to insulin resistance] than body mass index," says Dr. Robert Gensure, endocrine specialist and pediatric bone density specialist at Montefiore Medical Center. "Insulin is a growth factor and it promotes growth in many tissues, including bone."

This means that some kids and teens who are overweight are actually becoming bigger-boned in response to the extra insulin their bodies are producing. Buzzetti's research is picking up on this change and using those bigger bones as an indicator of the higher levels of insulin that put kids at risk for future heart disease and diabetes.

Copyright 2011 ABC News Radio


How Can You Protect Yourself in a Plane Crash? Five Tips for Surviving 

Digital Vision/Thinkstock (BOSTON) -- More than one in ten Americans say they are afraid of flying. It's the first jolt of moderate turbulence that gets our hearts pounding and out bodies shaking, even though we know it's an irrational fear.

Most of us have heard the facts and know that we're safer in the skies than on the highway, but that still doesn't stop most of us from dreading that takeoff.

MIT airline safety expert Arnold Barnett did a study on aviation safety and found that the chance of dying on a scheduled flight, from propeller planes to jetliners, in the United States is 1 in 14 million. At that rate, you would have to fly every day for 38,000 years before you had a fatal accident.

His MIT colleague John Hansman agrees flying is the safest mode of travel available today. "Riding on a commercial airliner has about the same risk as riding on an elevator," says Hansman.

And as pilots always seem to remind us, flying is 22 times safer than driving your car. Still, all it takes is a few stories on close calls to bring back that emotional fear of flying.

So what are the chances of you surviving one of those extremely rare accidents? Believe it or not, the National Transportation Safety Board says 76 percent of passengers do survive the most serious of crashes.

Here are some ways to protect yourself if you're still nervous:

1. Sit within five rows of an emergency exit.

2. Make a mental note of how far away you are from the nearest exit.

3. Sit in an aisle seat.

4. Sit in the rear of the cabin. It is statistically safest.

5. Don't sleep during takeoff and landing. That is when most accidents occur.

So why are we so afraid of flying? Professor Barnett blames the media. Over a two-year period, he studied the front page of The New York Times, looking for stories on flying. He found that for every 1,000 homicides, The Times published fewer than two stories. For every 1,000 AIDS deaths, there were 2.3 AIDS stories. But for every 1,000 airplane fatalities, there were 138 plane crash stories.

Copyright 2011 ABC News Radio 


HHS in Campaign to Cut Hospital Errors

Thomas Northcut/Thinkstock(WASHINGTON) -- Health and Human Services Secretary Kathleen Sebelius on Tuesday announced a national program to help save 63,000 lives and up to $35 billion in health care costs over the next three years by preventing hospital-related injuries.

"Americans go the hospital to get well, but millions of patients are injured because of preventable complications and accidents," Sebelius said. "Working closely with hospitals, doctors, nurses, patients, families and employers, we will support efforts to help keep patients safe, improve care, and reduce costs. Working together, we can help eliminate preventable harm to patients."

Sebelius was joined by hospital leaders, employers, insurers, doctors, nurses and patient advocates.

As many as one-third of hospital visits lead to hospital-related injuries, according to an April 7 report in Health Affairs. The missteps range from hospital-acquired infections to deadly surgical mistakes.

Sebelius said under the Partnership for Patients, HHS would invest up to $1 billion in federal funding through the Affordable Care Act.

The Community-based Care Transitions Program pledged $500 million and the Centers for Medicare & Medicaid Services will pitch in up to $500 million more to achieve the partnership's two main goals: To reduce preventable injuries by 40 percent; and cut preventable hospital readmissions by 20 percent.

"Reaching those targets would save up to $35 billion over the next 10 years," Sebelius said, adding that $10 billion of that would come from Medicare savings. "That's a return of up to $10 for each dollar we're investing."

Copyright 2011 ABC News Radio


Fat Weight Loss Experts Fight Misperceptions

BY LIZ NEPORENT, ABC News Medical Unit

(NEW YORK) -- Being called a fatty in front of 200 people is embarrassing for anyone. When you're a registered dietitian getting paid to lead a discussion on dieting and weight loss it's especially humiliating.

Bill Bradley grew up fat in a family of fat people who were obsessed with Weight Watchers and Overeaters Anonymous. Even at points in his life when he wasn't particularly overweight, he was still focused on food, eating and weight. That he chose dietetics as a profession is a bit like being raised as an arsonist and deciding to become a firefighter.

As Bradley began his internship, he was in a relatively svelte phase. He recalls encountering some overweight dietitians during his training and wondering how they had the audacity to give anyone guidance about shedding pounds. They so obviously wore their own struggles with food on their sleeve -- and thighs, buttocks and waistlines.

Bradley's coursework was stressful. Food helped him deal with the stress. By the end of his internship, he found himself in the uncomfortable position of being one of those chubby health experts dispensing advice not personally followed.

Now faced with a mocking question about his burgeoning belly in front of a large crowd, Bradley felt a momentary wave of shame pass over him but quickly recovered. He spoke from the heart and he spoke the truth.

"I'm not perfect and I have struggled with weight issues my whole life," he responded. "That's why I'm a dietitian. Not just to help other people, but to stay focused on helping myself too."

It's an interesting thing to be both a person who assists others with weight loss while battling weight demons of your own. Bradley points out that the vulnerability of such a professional conundrum has worked to his advantage because it makes him more accessible to clients. It's a lot easier confessing a midnight run for cookie dough ice cream to a nutritionist who has taken that same trip many times himself than to one who is a size zero vegan.

On the other hand, what gives someone the right to dispense health information they don't follow, won't follow or can't prove works? Isn't their credibility buried underneath a mountain of excess flab?

While Bradley has since lost weight and believes he never lost clients or potential clients because he didn't look the part, he admits he wouldn't go to an obese cardiologist. Which is exactly what Joseph F. Majdan was before he dropped "epic amounts of weight" about 18 months ago.

In Majdan's case, it was his fellow doctors, not his patients, who let him know how they felt about his adiposity. Over the years, they called him names like Fat Albert and asked if his lab coats were made by Omar the Tentmaker. In one particularly cruel and damaging episode, an oncologist refused to send a patient to him dismissing him as too fat to be a good doctor. She came to see him anyway, choosing to judge him not by the depth of his fat tissue, but by the depth of his character.

"My colleagues will look at cancer and drug addiction with compassion but some cannot look at overweight in the same vein," Majdan said. If they treat one of their own with such distain, what must they think of their obese patients?

Majdan said that in a way, fat has become a civil rights issue. "It's one of the last remaining prejudices where it's PC to make jokes at someone's expense. Perhaps that's why it's easy to be so judgmental about fat health experts," he said.

You can poke at the soft belly of your fat nutritionist or doctor (or nurse or personal trainer) and accuse them of being a hypocrite like a divorced marriage counselor or barber with bad haircut. It's easy to be dismissive if you've never fought against the complex cocktail of DNA, environment, health habits and dozens of other factors that make fat cling to our bodies.

Even when you've done everything right, you sometimes still come out on the gaining end. Going to school and learning all you can does not exempt you from the biological struggle. It doesn't.

Both Bradley and Majdan say their desire to be at an ideal weight wasn't a response to any criticism. Like you and me, they wanted to be healthy and feel good about themselves. Perhaps this makes them ideal health experts: Someone who once was fat but now is thin.

This provides them with a good understanding of what 66 percent of the population who are overweight and obese go through on a daily basis, but allows them to look the part of the stick-thin genetic lottery winner. It's a lose-win scenario.

Copyright 2011 ABC News Radio

ABC News Radio