Price of Preventing Premature Births Skyrockets

Comstock/Thinkstock(NEW YORK) -- Preventing preterm births just got 150 times more expensive, now that KV Pharmaceuticals has gained exclusive rights to produce a progesterone shot used to prevent premature births in high-risk mothers.

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.

Though KV Pharmaceuticals plans to offer financial assistance to low-come households in need of the drug, how private health insurance companies and Medicaid will respond to this price spike remains to be seen, leaving many doctors fearing that access to this treatment will become severely limited or interrupted for those currently mid-treatment.

And because FDA laws prohibit compounding pharmacies from making FDA-approved products, doctors will be legally obligated to stop using the cheaper version of this drug, a representative for the company told ABC News.

KV Pharmaceutical's response to the price controversy has been to announce a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, drugmakers KV Pharmaceuticals and partner company Ther-Rx, write: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

This translates into providing the drug for free to households making less than $60,000 annually who "apply for and are eligible for patient assistance." Those making $60,000 to $100,000 will be able to obtain it "at a cost that is comparable to the average copay assigned by commercial insurance," and those who are insured and make less than $100,000 will have a copay of $20 or less guaranteed to them, according to a company statement.

Dr. Alan Fleischman, medical director of the March of Dimes, which supported the FDA approval, says that the company has promised to make Makena available to all, regardless of ability to pay and the March of Dimes "stands ready to watch that process and hold them to their promise."

Copyright 2011 ABC News Radio 


Risk of Broken Bones Increases with HIV

John Foxx/Thinkstock(DENVER) -- The risk of bone fractures is higher for people living with HIV, researchers say.

Benjamin Young, MD, PhD, of the Rocky Mountain Center for AIDS Research, Education and Services in Denver, and colleagues reported that because the patient's immune system is in such a vulnerable state -- or at its lowest CD4 count -- risk of bone fracture is much greater. 

The study found that fragility fractures at the wrist, vertebra and femoral neck appear to be the main prompts for the increased risk.  Authors of the study also saw an association between fracture risk and factors like old age, substance abuse, hepatitis C co-infection and diabetes.

After the analysis of approximately 120,000 veterans, a 2010 report also indicated HIV could be a risk factor for fragility fractures.

Dr. Young hopes that the study's findings will help to advance bone health management for HIV patients, noting that the current method of care for this problem "is not well defined and remains controversial."

Young and colleagues reported their findings online in Clinical Infectious Diseases.

Copyright 2011 ABC News Radio 


FDA Approves Increased Availability of Prostate-Cancer Drug Provenge

Comstock/Thinkstock(NEW YORK) -- The U.S. Food and Drug Administration has approved an increase in production of prostate cancer drug Provenge to four times its current capacity.

The drug was initially approved by the FDA last April, but demand for the drug exceeded the company's original production constraints.

Provenge combats prostate cancer by inducing an immune response to the disease with the use of a patient's own cells.  After the cells are shipped to Dendreon Corporation, the drug's manufacturer, they are processed and returned to the patient's medical doctor and administered through an IV.  This process must take place three times over a four week period.

The FDA's approval to increase production now allows Dendreon to grow its number of workstations from 12 to 48.

Chief Executive Mitchell Gold told The Wall Street Journal Thursday, "The availability of the increased capacity is going to allow more treatment centers across the country to access Provenge."

Originally, Provenge was offered at 50 clinical sites at last year's launch.  But the company expects the drug to be available at around 500 sites by the end of this year.

Copyright 2011 ABC News Radio


Sleep Deprivation May Lead to 'Optimism Bias,' Study Suggests

BananaStock/Thinkstock(DURHAM, N.C.) -- People who suffer from sleep deprivation may possess the tendency to make overly optimistic decisions, thus making them more likely to take larger financial risks -- particularly when gambling, according to a recent Duke University study.

Researchers in the study, published this week in the Journal of Neuroscience, asked 29 healthy adults to perform a series of gambling tasks after one normal night of sleep and again after staying up all night.

Next, the investigators took MRI scans of each volunteer and found that those who had been deprived of sleep had heightened activity in areas of the brain that assessed positive outcomes, while more rested individuals showed decreased activity in the areas that process negative outcomes.

"Using a risky decision-making task, we showed that sleep deprivation shifted most persons' bias from avoiding loss to pursuing gain," reported the Duke University researchers in North Carolina and Singapore.

The researchers concluded that lack of sleep "appears to create an optimism bias; for example, participants behave as if positive consequences are more likely (or more valuable) and as if negative consequences are less likely (or less harmful)."

That said, lead author Vinod Venkatraman, a Duke graduate student Psychology and Neuroscience, suggests that merely drinking caffeine or exercising are not enough to battle the effects of sleep deprivation.

"Late-night gamblers are fighting more than just the unfavorable odds of gambling machines; they are fighting a sleep-deprived brain's tendency to implicitly seek gains while discounting the impact of potential losses," he said.

Copyright 2011 ABC News Radio 


Majority of Women Would Have Sex Every Day to Keep Weight Under Control

Brand X Pictures/Thinkstock(NEW YORK) -- Women will apparently do most anything, including have sex each and every day, in order to avoid gaining weight.  A recent survey of 1,000 women by Slim-Fast finds 59 percent of respondents would have sex every day if it meant losing weight and keeping it off.

Additional findings from the Slim-Fast survey:

    * 45 percent of women surveyed would never have another glass of wine or any other alcohol if it meant they would never gain another pound.
    * 35 percent would never have coffee if it meant they would never gain another pound.
    * 29 percent would never touch chocolate again if it meant they would never gain another pound.
    * When asked if they would give up their best friend to never gain another pound, only five percent of women surveyed would choose to never speak to their best friend again.

Women also were asked to identify their most significant motivation to slim down:

    * Get into a bathing suit for the summer -- 40 percent
    * New Year’s Resolution -- 33 percent
    * Weddings -- 25 percent
    * High school reunions -- 20 percent

Copyright 2011 ABC News Radio 


Marathon Runner Eats McDonald’s Three Times a Day

Tim Boyle/Getty Images(CHICAGO) -- Filmmaker Morgan Spurlock showed the perils of eating nothing but McDonald's food in his 2004 documentary Super Size Me, but Joe D'Amico apparently never saw the movie -- because he's been eating Mickey D's three times a day as part of his training for running a marathon. 

The Chicago Sun-Times reports D'Amico is set to run in the Los Angeles Marathon on March 20 after spending 30 days eating nothing but McMuffins, McNuggets, and other McDonald's menu items. 

D'Amico tells the newspaper, "My wife told me I was crazy, but I love McDonald's and I love running, and this was a great way to combine the two." 

D'Amico eats breakfast, lunch and dinner at McDonald's, but hasn't gained any weight because he runs 100 miles a week. 

Filmmaker Spurlock famously gained 24 pounds and watched his health decline when he ate nothing but McDonald's for just 30 days.

Copyright 2011 ABC News Radio 


Could Blood Test to Detect Early Lung Disease Help Smokers Quit?

Brand X Pictures/Thinkstock(NEW YORK) -- Despite evidence that smoking damages the lungs, people continue to smoke. But a new blood test may be more definitive proof that it's time to quit, say researchers.

Lung disease covers a range of disorders from asthma and influenza to COPD, TB, and cancer. Some of the warning signs include chronic coughing, shortness of breath, wheezing, coughing up blood or chest pains.

But this blood test may detect the early onset of the lung disease emphysema.

According to a report in the American Journal of Respiratory and Critical Care Medicine, researchers identified a specific physical trait in the blood of smokers with early lung disease.

That same biomarker was present in the blood of smokers who were not sick, but it was not found in the blood of non-smokers.

The authors concluded that the presence of this biomarker could be an early indication of emphysema.

They suggest that a blood test showing smokers are developing lung disease may be a stronger incentive to kick the habit than the threat of being at risk of getting the disease.

Copyright 2011 ABC News Radio 


Clean Water, Shelter Among Top Health Concerns Following a Tsunami

STR/AFP/Getty Images. Tsunami tidal waves move upstream in the Naka river at Hitachinaka city in Ibaraki prefecture in Japan.(ATLANTA) -- After a tsunami hits, like the one that struck the northeastern coast of Japan Friday following an 8.9-magnitude earthquake, the primary public health concerns are providing survivors with clean drinking water, food, shelter, and medical attention for any injuries, according to the Centers for Disease Control and Prevention.

Flooding spurred by tsunamis can contaminate water and food supplies, posing a risk to people's health.  Furthermore, the giant waves can displace people from their homes, leaving them susceptible to insect exposure, heat, and several other environmental hazards.

Although the majority of deaths that result from tsunamis are related to drownings, the CDC says victims can be inflicted with many injuries, such as broken limbs and trauma to the head, as they are washed into debris and rubble left behind from the environmental disaster.  It is imperative that people be treated for these injuries before they worsen, especially in areas where not many medical resources exist.

It is not yet known how many people have been affected by the massive tsunami that hit Japan Friday, but the death toll is expected to be well into the hundreds. The full impact of the quake will be better known Saturday once daylight hits the region.

Copyright 2011 ABC News Radio


Daylight Saving Time: How to Cope With the Loss of an Hour

Jupiterimages/Thinkstock(PHILADELPHIA) -- This weekend, the clocks spring forward into daylight saving time -- the bittersweet adjustment that brightens the evenings while wreaking havoc on sleep schedules.

For most people, the shift is a nuisance.  But for some, it provokes weeks of sleep deprivation that take a heavy toll on mood and productivity, according to Dr. Phil Gehrman, clinical director of the University of Pennsylvania's Behavioral Sleep Medicine program.

Since researchers began studying the effects of daylight saving time in the 1970s, the missing hour has been blamed for spikes in car accidents and workplace injuries, as well as dips in stock market returns.

"People think, 'It's only an hour.'  But considering that most people aren't getting enough sleep to begin with, they often underestimate what an hour can do," Gehrman said.

The results are similar to jet lag.  But no one gets jet lag when they lose an hour traveling one time zone east.

"That's because there's more light in the morning, and that helps you adjust your body clock," said Dr. Alfred Lewy, chairman of psychiatry and director of the Sleep and Mood Disorders Laboratory at Oregon Health and Science University in Portland, Oregon.  "But with daylight saving time, the new light-dark cycle works against your body clock. The extra light at the end of the day shifts it the wrong way."

The body clock is a cluster of neurons deep inside the brain in an area called the hypothalamus.  It generates the circadian rhythm, or sleep-wake cycle, that spans roughly 24 hours.  But it's not precise.

"It needs a signal every day to reset it," Lewy said.

The reset signal is light, which comes in through the eyes and transmits signals -- separate from those involved in vision -- that update the clock.  But when the sleep-wake and light-dark cycles don't line up, people feel out-of-sync, tired and even depressed.

Copyright 2011 ABC News Radio


Drinking Coffee May Cut a Woman's Stroke Risk, Study Finds

John Foxx/Thinkstock(STOCKHOLM) -- Swedish researchers say women who have at least one cup of coffee each day may reduce their risk of stroke by up to 25 percent.

They add that women who do not drink coffee may be increasing their risk of suffering a stroke.

"Results from our study in women showed that consumption of one to five cups of coffee per day was associated with a 22 to 25 percent lower risk of stroke, compared with consumption of less than one cup a day," said Susana Larsson, the lead researcher from the National Institute of Environmental Medicine at the Karolinska Institute in Stockholm.

In the study, published in Thursday's issue of Stroke, the researchers examined data on 34,670 women, ages 49 to 83.  They found that between 1998 and 2008, 1,680 women suffered a stroke, but coffee drinkers saw a 22-25 percent lower risk.

Investigators in the study theorized that the coffee might reduce inflammation, improve insulin resistance and lessen oxidative stress, causing a decreased risk of stroke.

Critics of the study note that there are too many factors not accounted for and say the link does not provide proof of a causal relationship.

However, the researchers did say that their findings were preliminary and that people should not change their coffee-drinking habits based on the study alone.

Copyright 2011 ABC News Radio

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