Gender Matters When Testing Pacemakers, Other Cardiovascular Devices  

Photo Courtesy - Getty Images(SAN FRANCISCO) -- One-third of women in America have heart disease.  Some of them will need pacemakers and other devices to help keep them alive.  But a new study casts doubt on how thoroughly these inventions are tested with specific reference to female patients.

Cardiovascular devices such as pacemakers can perform differently in men and women.  In 1988, the Food and Drug Administration called on the makers of medical devices to include women in their test studies.

Now a report in the journal Circulation finds only a few studies include enough women or analysis on how critical devices work specifically in female patients.  The authors review 123 studies involving 78 cardiovascular devices such as heart valves and implanted defibrillators.

In 34 of the studies, the sex of the participants was not reported.  In those that were broken down by sex, 67 percent of the participants turned out to be men.  Only half the studies complied with an FDA requirement to explain why more men than women were used.  And just 12 actually reported sex-specific data. 

The authors say this means there just isn't enough gender-specific information on safety and effectiveness of these high risk devices that require FDA approval.

They say women should be encouraged to enroll in medical trial -- and female patients should ask whether a device they get has been tested on women.

Copyright 2011 ABC News Radio


Federal Judge to Clarify Ruling On Health Care Law

Photo Courtesy - Getty Images(WASHINGTON) -- Federal Judge Roger Vinson is poised to issue an order this week clarifying the ruling he made on Jan. 31, 2011, that struck down the entire health care law.

Why does he need to clarify? Because the Obama administration argues it isn’t sure whether Vinson’s ruling was meant to halt the implementation of provisions of the law currently in effect.

Vinson found the individual mandate to be unconstitutional, and he said that the rest of the law could not stand without the mandate, but he declined to impose an injunction which would have immediately blocked the enforcement of the law. Instead he said his ruling was the “functional equivalent of an injunction.”

It’s all a bit of a legal gymnastics because if the administration gets an adverse ruling from Vinson it will immediately appeal to the 11th Circuit.  It’s highly likely that the 11th Circuit would grant a stay.

What parts of the law currently in effect are at issue? The White House says in a blog: “Seniors will pay higher prices for their prescription drugs and small businesses will pay higher taxes because small business tax credits would be eliminated. And the new provisions that prevent insurance companies from denying, capping or limiting your care would be wiped away.”

Meanwhile, the state of Florida, which brought the challenge along with 25 other states, says the administration is playing games: finding a platform to criticize the judge’s ruling when it could have simply immediately asked for a stay.

Copyright 2011 ABC News Radio


K2 Crackdown: DEA Bans Fake Pot

Photo Courtesy - ABC News(NEW YORK) -- The sale of K2, a once-legal but potentially dangerous form of synthetic marijuana, is now banned nationwide.

The ban, proposed in November 2010 amid increasing reports of seizures, hallucinations, and dependency linked to the fake pot, was "necessary to prevent an imminent threat to public health and safety," according to the Drug Enforcement Administration. It has now banned K2 and five chemicals used to make it.

K2 was sold openly in head shops and online as incense. It largely avoided regulation in the United States because it was sold in packages that stated it was not for human consumption.

Little is known about the long-term effects of the fake pot, also known as Spice, Demon, Genie, Zohai, and a host of other names. But its short-term effects, which include soaring heart rates and paranoia, have landed some of those who smoked it in the hospital. In some instances, the drug has been linked to suicide.

K2 was first developed by an undergraduate student in the lab of Clemson University chemist John Huffman. Its active ingredients are synthetic cannabinoids, chemicals that imitate the effects of tetrahydrocannabinol (THC), the active ingredient in marijuana. Huffman said the chemicals were designed as "research tools" and never intended for human consumption.

Three of the five banned chemicals -- JWH-018, JWH-073, JWH-200 -- bear Huffman's initials in their names. The other two are CP-47,497, and cannabicyclohexanol. 

Copyright 2011 ABC News Radio


Restrictive Diets May Improve ADHD Symptoms in Children

Photo Courtesy - Getty Images(THE NETHERLANDS) -- Attention Deficit and Hyperactivity Disorder -- known as ADHD -- is the most common psychiatric disorder in children.  It has been diagnosed with increasing frequency in the U.S., and there is controversy over the widening use of drugs to treat its symptoms among the young.

ADHD has been diagnosed in 5.4 million children as of 2007.  The foremost symptoms are inattention, overactivity and impulsive behavior. The cause of ADHD is unknown.

But a recent study, published in the British journal Lancet, suggests that in some cases, ADHD may be triggered by certain foods.  So it may respond to what is called a "restricted elimination diet." That means removing foods one by one from a patient's diet until the food or foods causing symptoms is discovered.

Of the 50 children with ADHD who had five weeks of a restricted diet, 32 showed improvement in symptoms -- compared to none of 50 other children not placed on the diet. When certain foods were re-introduced to 30 children who had responded to the diet therapy, 19 had a relapse of symptoms.

The authors conclude that diet modification should be considered for kids with ADHD.

Copyright 2011 ABC News Radio 


Girl With Rare Facial Deterioration Saved by Surgery

Photo Courtesy - Getty Images(MADISON, Wis.) -- Christine Honeycutt's battle with a rare disease started about six years ago with something doctors and her mother thought was nothing more than a birthmark.

"I noticed a small line in her forehead.  It looked like she ran into a door jamb," said Vicki Honeycutt, Christine's mother.

Doctors told Honeycutt not to worry too much.  They gave her cream to put on it, instructed Christine, then only 5 years old, to stay out of the sun and said it would eventually fade away.

Over the years, despite doctors' reassurances, the line only got darker and deeper and one summer, after moving from North Carolina to southern California, Honeycutt noticed something else.

"One day, I kissed her ear and then she rolled over and her right ear was in my face. I noticed her left ear was half the size of her other ear, and also that her nostril on her left side looked like a baby's nostril," she said.

After a visit to another pediatrician, numerous tests and then a consultation with a genetic specialist the pediatrician recommended, Honeycutt had a diagnosis: Parry-Romberg Syndrome, a rare condition that progressively causes the skin and tissue of one side of the face to waste away.  The degree of atrophy varies from person to person.  No one knows what causes the disease and there is no cure.

Patients with Parry-Romberg may also have neurological symptoms, such as seizures and severe migraines.  Honeycutt said Christine had a seizure when she was seven and also suffered from severe pain in her face as well as bloody noses.

Even though the condition has no cure, that wasn't going to stop Honeycutt from trying to save Christine's face, despite the fact that numerous doctors told her there was no hope.

There have been case reports that methotrexate, a cancer drug, stopped Parry-Romberg's progression.  But it didn't work for Christine, who has since moved back to North Carolina with her family.

After the unsuccessful treatment with methotrexate, Honeycutt found Dr. John Siebert, professor of surgery at the University of Wisconsin School of Medicine in Madison.  Siebert has performed a special type of microsurgical reconstruction on about 120 people with Parry-Romberg Syndrome.

He operated on Christine on Nov. 15.  The surgery involved taking tissue from the area under her arm near where her breast would be and transplanting it into her face.  Siebert said the tissue already had working blood vessels.

Siebert said Christine's first surgery went well.  She will have to have another surgery in the spring for what he calls "fine tuning."  He'll remove some of the extra tissue that's caused some swelling. 

Copyright 2011 ABC News Radio


Optimism Linked to Improved Survival With Coronary Artery Disease

Photo Courtesy - Getty Images(CHICAGO) -- Can a smile a day keep your heart okay? Some researchers are now saying say it might.

A new study released Monday and published in the Archives of Internal Medicine adds to growing evidence that having a positive attitude can help you live longer.

Researchers looked at nearly 3,000 patients who underwent hospital treatment for heart disease and found that those who had the highest expectations of a full recovery had a higher chance of living longer than those who were pessimistic about their chance of recovery.

Study researchers also noted that those who are generally optimistic about their health are more likely to follow treatment recommendations.

On the other hand, those who are pessimistic about their health may experience stress that could trigger additional heart problems, researchers said.

The nearly 3,000 patients enrolled were followed for 15 years. One year after their hospital stay, they were asked to fill out a survey that would help researchers learn more about their attitude.  The group of patients with a better perspective on their health had lived nearly 20 percent longer than those who seemed pessimistic. Optimistic patients also lived a more active lifestyle than the pessimists.

Previous studies looking at other potentially fatal diseases including cancer suggest that a positive outlook can affect not only your quality of life, but also whether you survive longer.

Copyright 2011 ABC News Radio


Diet: Starving on Pregnancy Hormones?

Photo Courtesy - Getty Images(NEW HAVEN, Conn.) -- With one-third of Americans obese and many more overweight, the nation is desperate for a weight-loss miracle. But the return of the HCG diet -- a fad popular in the 1970s that combines daily injections of "human chorionic gonadotropin" and extreme caloric restriction -- has some weight-loss experts worried.

"We're so desperate to have good solutions for weight control that a lot of people with good common sense literally suspend it when it they confront weight-loss claims," Dr. David Katz, director of the Yale University Prevention Research Center, said. "This diet is appalling. It takes irresponsible diets to new heights."

HCG is a hormone first produced by the developing embryo and then the placenta during pregnancy to help nourish the womb. Because calories are rerouted from mother to fetus during pregnancy, HCG diet promoters say, injecting the hormone will help curb appetite and allow dieters to get through a day on the energy equivalent of a turkey sandwich.

"A 500-calorie-a-day diet is just plain dangerous," Katz said. "When you restrict calories to that level, there's a real risk for not providing your body with enough essential amino acids, so it scavenges itself. In some instances, it can cause the body to scavenge from critical places, like the heart."

The danger of very low-calorie diets has been well documented since their rise in popularity in the '70s. A 1981 study published in the American Journal of Clinical Nutrition described 17 people, all of whom were initially obese and had significant and rapid weight loss, who died suddenly of ventricular arrhythmia after a median five months of dieting.

The lowest recommended caloric intake per day is 1,200 calories for women and 1,500 for men, according to the National Institutes of Health. Restricting calories beyond those limits should only be done under doctor supervision because of the health risks.

Copyright 2011 ABC News Radio


FDA Urges Removal of Zinc from Denture Creams, Citing Nerve Damage Studies

Photo Courtesy - Getty Images(WASHINGTON) -- After receiving more than 360 complaints that long-term overuse of the popular denture cream Fixodent caused serious nerve damage, the Food and Drug Administration last week urged denture cream makers to remove zinc, modify package labels and conduct further research of risks.

As ABC News reported earlier this month, excessive long-term use of zinc-containing denture creams like Fixodent may cause serious and irreversible neurological damage. Poligrip, the other leading denture cream, no longer contains zinc.

An exclusive ABC News investigation also uncovered that a paid consultant to Proctor & Gamble, maker of Fixodent, did not disclose a possible conflict of interest when he peer-reviewed a scientific study of four patients that suggested a link between an overuse of denture cream containing zinc and nerve disease.

In a Notice and Recommendation Action dated Feb. 23, 2011, the FDA wrote: "Although zinc is an essential nutrient, overexposure may result in zinc toxicity. We are notifying all manufacturers of denture adhesives and asking for their assistance in dealing with this public health issue."

Consumers most at risk are those "using excessive amounts of the products over extended periods of time; people with poor fitting dentures; and people who are unable to read or understand product labeling," the FDA wrote.

It "strongly recommends" manufacturers of denture creams that contain zinc, including Fixodent, to consider "replacing zinc with an ingredient that presents less health risks in situations of overuse."

Proctor & Gamble on Monday told ABC News that it is in active discussions with the FDA on this topic, that it takes the recent notice very seriously, and that it is "carefully considering the FDA's recommended actions."

The company also mentioned that it has already changed its product label to caution customers about overuse of the product, and said it is "always looking for new and improved formulas as we strive to improve our products."

Copyright 2011 ABC News Radio


Sugary Drinks Could Increase Blood Pressure, Researchers Say

Photo Courtesy - Getty Images(NEW YORK) -- It may be necessary for people with high blood pressure to watch their sugar as well as their salt intake, according to a new study. 

The study, published in the journal Hypertension, found that individuals who consumed the most sugar-sweetened drinks such as soda and fruit juices had higher blood pressure.  The problem may be worsened when salt is added.

"Individuals who consume more soda and other sugar-sweetened soft drinks may have higher blood pressure levels than those who consume less, and the problem may be exacerbated by higher salt intake," Dr. Ian J. Brown of Imperial College London wrote in an email to ABC News and MedPage Today.

Researchers in the study focused on 2,696 patients from the U.S. and U.K., taking information from urine collections and blood pressure readings.  The patients also reported on their diets over a four-day period.

The collected data showed a consistent increase in blood pressure with every extra fruit beverage or soda consumed by a patients.

Study authors also reported that people who consumed more sugar-sweetened drinks on a daily basis also tended to have less healthy diets overall than those who had less sugary beverages.

"It appears that empty calories from these drinks displace calories from other foods that have beneficial nutrients such as minerals and vitamins," Dr. Brown said.

Copyright 2011 ABC News Radio 


Making Surrogate Treatment Decisions Can Take Its Toll

Photo Courtesy - Getty Images(BETHESDA, Md.) -- When crisis strikes and a person is no longer able to make their own medical decisions, spouses, adult children, siblings and others find themselves in the role of surrogate decision-makers, trying to make the best, yet often difficult, decisions for their loved ones.  Studies have shown that the critical role of the surrogate decision-maker can be incredibly stressful.

For the first time, a study has systematically examined on a large scale the psychological after-effects of decision making on surrogates.  Researchers at the National Institute of Health reviewed 40 published articles providing data on 2,832 surrogates who were surveyed several months to years after making treatment decisions, including end-of-life decisions.

At least one-third of the surrogates experienced negative effects including stress and anxiety, and these effects were often substantial and lasted for months or years. But surrogates that knew the patient’s wishes – if, for example, the patient had a living will – suffered less stress than surrogates acting without advance directive.

The findings were published in the Annals of Internal Medicine.

Copyright 2011 ABC News Radio

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