FDA Approves 39 New Drugs in 2012

Both pharmaceutical companies and officials at the U.S. Food and Drug Administration have been busy — the drug companies compiling statistics from clinical research trials and the FDA going through its vetting process to ensure the safety and efficacy of proposed new medications. The most recently approved medication, Sirturo, was developed for the treatment of multi-drug resistant tuberculosis, MDR-TB, an infection rarely seen in the United States but prevalent in China, Eastern Europe, Russia and India.

FDA 2012 Approval Numbers

In the last 20 years, the greatest number of new approvals occurred in 1996 when 53 new medications were added to the marketplace. In 1997, 39 new drugs met FDA approval. Approvals slowed for some years until 2004 when 36 approvals were awarded by the FDA, then slowed again until the 39 approvals in 2012.

Newest Tuberculosis-Fighting Drug Fast-Tracked by FDA for Approval

Johnson & Johnson’s drug Sirturo, or bedaquiline, intended for the treatment of drug-resistant strains of tuberculosis, received a speedy go-ahead to market, a process used by the FDA when preliminary clinical research demonstrates positive results.

Tuberculosis, caused by bacteria that most often affects the lungs, is rarely seen in the United States but is rampant in other areas of the world. As many as 1.4 million people die worldwide annually from the illness, with approximately 150,000 of those deaths from MDR-TB.

Sirturo, the first new anti-tuberculosis drug to market in more than 40 years, is not without its concerns. Designed to be used in conjunction with the older anti-tuberculosis medications, Sirturo carries a boxed warning on its label that it can interfere with the heart’s electrical system, something that could result in fatal arrhythmia .

Bedaquiline is not intended as a first line of defense against tuberculosis infection, but rather when all other available treatments have been ineffective. Left unabated, the tuberculosis could lead to death and at that point in the illness health care providers would need to weight the possible side effects of a medication that could save the person’s life by clearing the infection.

New Medications Approved by FDA in 2012

The FDA provides a listing of new and generic drugs the agency approved in 2012. Drugs in the listing include Eliquis, a blood thinner for people with atrial fibrillation not related to a heart valve problem; Juxtapid, an anti-cholesterol medication for people with an uncommon genetic disorder affecting LDL cholesterol levels; and Iclusig, another medication that received fast-track approval, for the treatment of two rare types of leukemia. Thirty-six other drugs also received approval.

Bottom Line

The discovery and clinical research that are behind each new drug is often long, arduous and expensive. MedCityNews.com reported that major pharmaceutical companies took a big financial hit in 2012 due to patents expiring on many large money-making medications, with cheaper generic drugs taking up the slack to the tune of $ 21 billion for U.S. drug makers and $ 10 billion for European drug makers.

As difficult as it can be to feel sympathy for the drug companies, the truth is manufacturing and distributing medications is a business. If profits fall too much, it is difficult to fund the discovery and research phases for potential new cures.

Everyone, from infants to baby boomers to centenarians, benefits from the continued science of pharmacy.

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Omega-3s may not protect against faulty heart rhythm

NEW YORK (Reuters Health) – Sorry, Charlie, but fish oil supplements did not prevent atrial fibrillation in patients who had already experienced episodes of the heart rhythm malfunction, a new clinical trial has found.

The study, published in the Journal of the American College of Cardiology, adds to a growing pool of disappointing evidence regarding the protective effects of omega-3 fatty acids on heart health.

“The results for atrial fibrillation are important negative findings, answering key clinical and research questions,” said Dr. Dariush Mozaffarian, an omega-3 expert at the Harvard School of Public Health, who was not involved in the current study.

The new research, combined with other trials, “indicates that short-term fish oil use is unlikely to prevent recurrent atrial fibrillation,” he said.

But if the supplements don’t prevent heart rhythm problems, they don’t appear to be dangerous, either. “In all these studies, fish oil was safe and well-tolerated, with no evidence for increased bleeding,” Mozaffarian told Reuters Health.

Atrial fibrillation, in which the heart’s upper chambers beat out of step with those below, affects nearly one in 10 Americans in their 80s. The condition is linked to potentially life-threatening strokes and heart failure.

Although doctors prescribe certain medications to treat the condition, none to date has proven particularly effective. As a result, most drug treatment focuses on preventing strokes by administering blood thinners to dissolve clots caused by the fibrillation.

Some evidence suggests that omega-3 fatty acids, found in oily fish like sardines and tuna, might reduce the risk of atrial fibrillation, although exactly how they would produce their effect is not clear.

A study published earlier this year in Circulation, for example, found that people with the most omega-3s in their blood had a 30 percent lower chance of developing an irregular heart beat than those with the lowest concentrations of the substances (see Reuters Health story of February 1, 2012).

That 30 percent difference would work out to eight fewer cases of atrial fibrillation per 100 people – which would be a meaningful benefit if it could be enjoyed by those with fibrillation or at risk for it, just by consuming more omega 3s.

But the latest study suggests that it probably can’t. The trial included 586 men and women with a history of atrial fibrillation who were given a gram a day of fish oil or dummy capsules for a year. Participants also were allowed to take other drugs to control their heart rhythms, as prescribed by their doctors.

At the end of the study period, about 24 percent of the people who took fish oil, and 20 percent of those who did not, had experienced a recurrence of atrial fibrillation – a difference so small, statistically, it was likely due to chance.

The supplements also did not appear to reduce the risk of other cardiovascular ailments – including stroke, heart attack, heart failure – or death from any cause.

The findings on atrial fibrillation echo results from a study led by Mozaffarian published in November, of patients recovering from heart surgery.

Even so, Dr. Alejandro Macchia, a cardiologist at the GESICA Foundation in Buenos Aires, who led the current study and collaborated with Mozaffarian on the previous one, said fish oil may still prove beneficial for heart health, at least in some patients.

“I am not sure the story is over,” Dr. Macchia told Reuters Health. “I think we have enough evidence to say that there is no role of (omega-3 fatty acids) for the prevention of atrial fibrillation” in patients with a history of the condition, he said. “However in the context of primary prevention – those people who had never had a previous episode of atrial fibrillation – there is a reasonable room for a well-designed and very large clinical trial.”

SOURCE: http://bit.ly/VrTKiY Journal of the American College of Cardiology, online December 19, 2012.

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U.S. approves J&J drug-resistant tuberculosis treatment

(Reuters) – U.S. health regulators have approved a new Johnson & Johnson drug for patients with tuberculosis who do not respond to other treatments, the company said.

The drug is the first in 40 years to tackle the disease using a new mechanism of action, according to J&J. The drug blocks an energy-producing enzyme that tuberculosis bacteria need to survive.

The U.S. Food and Drug Administration approved the drug, chemically known as bedaquiline and to be marketed as Sirturo, on Monday following a positive review by an advisory panel last month.

Tuberculosis is an air-spread infection that usually attacks the lungs but it can also affect the brain, the spine and the kidneys.

In 2011, nearly 9 million people around the world became sick with TB, according to the Centers for Disease Control and Prevention, and there were 1.4 million TB-related deaths. The disease requires six to nine months of drug treatment.

TB is more prevalent now than at any time in history, FDA Commissioner Margaret Hamburg wrote in a blog on the FDA website. This drug will help treat and cure patients who are putting themselves and others at serious health risk, she said.

The drug itself has significant potential risks, she wrote, and will carry a warning about an increased rate of death observed in patients who received it.

Her comments followed those of the FDA advisers who found the drug to be effective, though they noted that more deaths were seen in the group of patients who took bedaquiline in combination with standard treatments than in the group that took standard drugs alone.

Doctors Without Borders said that the drug was a “potential game changer” against drug-resistant forms of the disease and an important milestone in fighting TB.

Multidrug-resistant tuberculosis is caused by strains of the bacterium that have become resistant to at least isoniazid and rifampin, the two most potent drugs for TB.

Support has not been unanimous. Consumer advocacy group Public Citizen earlier this month said it had written to the FDA because of the risks of death asking it not to approve of the drug, which received a fast approval.

DETAILS FROM TRIAL

Chrispin Kambili, medical affairs leader for bedaquiline at J&J’s Janssen Therapeutics unit, said in a recent interview that the company is studying the difference in death rates but has so far seen no common pattern.

Almost every death was due to a different cause, including a motor vehicle accident. What was unusual, he said, was the low rate of death in the placebo group.

Advisers to the FDA expressed concern that a greater number of patients had elevated liver enzymes, a potential sign of liver toxicity, and elongated QT levels, an electrical irregularity in the heart that can cause sudden death.

But Kambili said none of the patients died due to serious QT prolongation and there was no unifying findings in the data.

Kambili said J&J’s drug is designed for a relatively small portion of patients – some 650,000 – who do not respond to existing therapies.

And while investment analysts at Cowen and Co have forecast peak annual sales of the product at a relatively modest $ 300 million, the drug is important from a public health standpoint, Kambili said.

J&J shares were 0.1 percent higher to $ 69.56 in late morning trading on the New York Stock Exchange.

(Additional reporting by Ransdell Pierson and Caroline Humer; Editing by John Wallace, Jeffrey Benkoe and Tim Dobbyn)

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Year in Review: Meningitis Outbreak Still a Challenge

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here’s what’s happened with the fungal meningitis outbreak since we published our first report.

The fungal meningitis outbreak that made headlines in the fall was “unprecedented,” in the words of the of the clinicians at the eye of the storm.

What’s more, “we’re not out of the woods yet,” said Tom Chiller, MD, deputy director of the CDC’s mycotic diseases branch.

The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.

It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.

“The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing,” Kauffman told MedPage Today. “The huge morbidity and, for some, mortality, is enormous.”

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The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called “compounding pharmacies.”

And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.

The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.

The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: “We’re still in the middle of this thing.”

Compounding Out of Bounds

The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.

That was problematic in itself: The company was licensed as a compounding pharmacy, meaning in principle it was allowed only to make up small quantities of specialized drugs, after getting a prescription from a doctor for an individual patient.

Instead, it was acting more like a large-scale drug manufacturer, and had been for some years, according to Massachusetts officials, which should have placed it under the FDA’s authority.

The manufacturing scale played a key role in what ensued: more than 13,000 people were exposed to the drug when they got injections – mainly into the spine – to control chronic pain.

They were also exposed to a fungal contaminant in the steroid vials, later found to be a black mold called Exserohilum rostratum, which only rarely causes human disease.

Oddly, the index case for the outbreak, reported to health authorities on Sept. 18, was a 56-year-old man in Nashville who had a case of meningitis apparently associated with the fungus Aspergillus fumigatus.

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MSF warns Kenya not to send more refugees to stricken camp

LONDON (Reuters) – Conditions in a camp for Somali refugees in Kenya are deplorable and a government plan to send in thousands more would pose a major risk to health, medical charity Medecins Sans Frontieres (MSF) said on Friday.

Kenya has more than half a million refugees from Somalia, which has lacked an effective central government since the outbreak of civil war in 1991.

A series of bombings, shootings and hand-grenade attacks blamed on Somali militants prompted the government on December 18 to stop registering asylum seekers and refugees in urban areas.

A Kenyan official said more than 100,000 refugees must now head to the remote Dadaab camp in the country’s remote north. Amnesty International said the order breached international law.

Dadaab camp was set up 20 years ago and already houses four times the population it was built for. Hunger and disease outbreaks are common.

MSF says its inhabitants suffer from overcrowding and poor sanitation that recent floods had worsened.

“The assistance provided here in Dadaab is already completely overstretched and is not meeting the current needs,” said Elena Velilla, MSF’s head of mission in Kenya.

In the last month, the number of children admitted to Dadaab’s hospital for severe acute malnutrition has doubled to around 300, MSF said. Sixty-three of those were taken to intensive care this week after developing serious complications.

Most of the sick are also suffering from acute watery diarrhea or severe respiratory tract infections, MSF said.

(Reporting by Kate Kelland; Editing by Tom Pfeiffer)

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Film explores African-Americans’ unhealthy “soul food” habit

(Reuters) – After interviewing food historians, scholars, cooks, doctors, activists and consumers for his new film “Soul Food Junkies,” filmmaker Byron Hurt concluded that an addiction to soul food is killing African-Americans at an alarming rate.

The movie, which will premiere on January 14 on U.S. public broadcasting television, examines how black cultural identity is linked to high-calorie, high-fat food such as fried chicken and barbecued ribs and how eating habits may be changing.

In the deeply personal film, Hurt details his father’s fight and eventual death from pancreatic cancer. A high-fat diet is a risk factor for the illness, according to researchers at Duke University in North Carolina.

“I never questioned what we ate or how much,” 42-year-old New Jersey-based Hurt says in the film that travels from New Jersey and New York to Virginia, Georgia, Mississippi, Louisiana and Chicago.

“My father went from being young and fit to twice his size.”

Hurt, who also made “Hip-Hop: Beyond Beats and Rhymes,” decided to examine the link between calorie-loaded soul food and illnesses among blacks after his father was diagnosed in 2006.

He delves into his family history, as well as slavery, the African diaspora and the black power movement in the film and provides photographs, drawings, historic film footage and maps.

In Jackson, Mississippi, Hurt joined football fans for ribs and corn cooked with pigs’ feet and turkey necks. He also visited Peaches Restaurant, founded in 1961, where freedom riders and civil rights activists including Martin Luther King Jr. ate.

Hurt, whose family came from Milledgeville, Georgia, grew up on a diet of fried chicken, pork chops, macaroni and cheese, potatoes and gravy, barbecued ribs, sweet potato pie, collard greens, ham hocks and black-eyed peas.

“The history of Southern food is complex,” he said. “In many ways, the term soul food is a reduction of our culinary foodways.”

The origins of the diet lie in the history of American slavery, according to food historian Jessica B. Harris, who appears in the film. Slaves ate a high-fat, high-calorie diet that would allow them to burn 3,000 calories a day working, she explained.

Southern food began to be called soul food during the civil rights and black power movements of the 1960s, according to Hurt.

“There’s an emotional connection and cultural pride in what they see as the food their population survived on in difficult times,” he said.

But Hurt said African-Americans are being devastated by nutrition-related diseases.

Black adults have the highest rates of obesity and a higher prevalence of diabetes than whites, and are twice as likely to die of stroke before age 75 than other population groups, according to the U.S. Centers for Disease Control and Prevention.

Besides tradition and habit, poverty and neighborhoods without good supermarkets also contribute to an unhealthy diet, Hurt said.

“Low-income communities of color lack access to vegetables and have an overabundance of fast food and highly processed foods that are high in calories and fats. I always know when I’m in a community of color because I see … very, very few supermarkets and health food stores,” he added.

In her book, “High on the Hog: A Culinary Journey from Africa to America,” Harris said the prevalence of overprocessed foods, low-quality meats, and second- or third-rate produce in minority neighborhoods amounts to “culinary apartheid.”

In the film, Marc Lamont Hill, an associate professor of English education at Columbia University in New York, described minority health problems related to poor diet as “21st-century genocide.”

Hurt says the government can help by increasing urban access to quality food and requiring calorie counts to be displayed on restaurant menus.

Nonprofit organizations such as Growing Power Inc., which runs urban farms in Chicago and Milwaukee, provide fresh vegetables to minority neighborhoods.

Brian Ellis, 21, said all he ate was fast food when he started working at one of Growing Power’s urban farms in Chicago when he was 14.

“Then I started eating food I’d never seen before like Swiss chard,” said Ellis, who appears in the film. “I never knew what beets were. I’d never seen sprouts before. I’m not that big of a beet fan, but I love sprouts. I could eat sprouts all day.”

(Editing by Patricia Reaney and Mohammad Zargham)

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Light Therapy Helps Ease Winter Blues

Every October as the clocks are turned back, Jose Balido notices that his mood changes, almost as if his body were going into hibernation.

His limbs are heavy and he has trouble moving around. Simple household chores like loading the dishwasher seem “insurmountable,” he said. But when spring arrives, the lethargy lifts.

“It took me a while to realize what it was,” said Balido, owner of a travel social network site, Tripatini. “I was cranky, short-tempered, depressed, feeling hopeless and having difficulty concentrating.”

Balido, 51, was diagnosed a decade ago with seasonal affective disorder or SAD. The condition affects 62 million Americans, according to Michael Terman, director of the Center for Light Treatment and Biological Rhythms at Columbia University and a leader in the field.

About 5 percent of the population experiences the most severe symptoms of SAD — depression and hopelessness — while another 15 percent have the so-called “winter blues” or “winter doldrums.”

The vast majority never fall into full depression, according to Terman, but “plod through winters with slowness and gloominess that takes effort to hide from others.”

Two decades ago, SAD was identified as a legitimate disorder by the National Institute of Mental Health. Since then, the treatment of choice has been light therapy.

Balido, who lives in Miami, sought help from Terman and now undergoes light therapy. He sits in front of a daylight simulator for a half an hour each morning before 10 a.m.

“Within two or three days, the difference was mind-blowing,” he said.

The standard treatment for SAD is 30 minutes of 10,000-lux, diffused, white fluorescent light, used early in the morning. About half the patients are helped quickly — and when treatment is tailored to a person’s individual wake-sleep cycle, remission can climb to 80 percent, according to Terman.

This year, a utility company in the northern Swedish town of Umea installed ultraviolet lights at 30 bus stops to combat the effects of SAD.

“We wanted to celebrate the fact that all our electricity comes from green sources and we wanted to do this in a way that contributed to the citizens in one way or another,” said Umea Energi marketing chief Anna Norrgard in an email to ABCNews.com.

“As it is very dark where we live this time of year, a lot of us are longing for the daylight,” she said. “A lot of us are also a bit more tired this time of year and I would also say we sleep a little bit more. …We wanted to give the citizens of Umea a little energy boost, to be more alert.”

The town is located about 400 miles north of Stockholm. In December, the sun rises at about 10 a.m. and sets around 2:30 p.m. Some towns north of the Arctic Circle have no daylight for several weeks in the winter.

Geography has a strong influence on the prevalence of SAD symptoms, according to Terman.

“The common wisdom is that it’s worse the farther north you live, because winter days are so much shorter,” he said. “Not so simple.”

Columbia research shows that in North America, the incidence of SAD rises from the southern to the middle states, but levels off and stays bad from about 38 degrees North latitude (near such cities as San Francisco, St. Louis and Washington, D.C.) up through the northernmost states and Canada, according to Terman.

But the problem becomes “more severe” at the western edges of the northern states and provinces.

“This important finding reveals the underlying trigger for relapses into winter depression, since the sun rises an hour more later at the western edge of a zone,” said Terman, whose book, “Chronotherapy,” looks at the phenomenon.

Esther Kane, a clinical counselor from Vancouver, Canada, said her practice is filled with patients as the long days descend on British Columbia.

Seasonal Affective Disorder Hits Hard in Canada

“On the West Coast where we live it’s so rampant, I can’t even tell you how many people have it,” said Kane. “Everyone is feeling it with the gray skies and rain. It’s like nighttime all the time here.”

Doctors there routinely prescribe fish oil and vitamin D, as well as light therapy to balance out the sleep hormone melatonin and “boost” the feel-good hormone serotonin, according to Kane. Many are also on antidepressants.

“A lot of people depend on alcohol and drugs all of a sudden,” she said. “They are stuffing themselves with carbs and their food intake is up. They have depression symptoms — what’s the point of getting out of bed in the morning when they feel no energy and there is dark all over them?”

“Some suffer so bad, they can’t function,” said Kane. “Everyone here who can afford to get away for two weeks in the winter, go to Hawaii.”

Even those who live south of the Mason-Dixon Line in the United States can be affected.

Tina Saratsiotis, who works for a faith-based nonprofit group in Towson, Md., was surprised to develop SAD several years ago.

“I used to be a night person and like the dark. Then something changed,” she said. “By fall when it gets darker and the fatigue and sadness comes and by Christmas, it’s difficult to function.”

“It creeps in slowly — I eat more and have trouble concentrating,” she said. “I am more irritable and weeping, like a prolonged version of PMS. It makes it hard to get things done and to enjoy things.”

Columbia’s Terman said there may be genetic influences in who gets SAD — a vulnerability to depression and to insufficient light exposure.

SAD sufferers say it’s especially hard on their relationships when their winter moods kick in.

“Now, he’s very understanding,” said Saratsiotis, who uses both light therapy and antidepressants to deal with the condition. “But before, when I didn’t feel up to going out, I couldn’t explain not feeling great. People wonder, ‘Why doesn’t she like me?’ and, ‘She’s no fun.’”

But when spring rolls around, so does her old self.

“I love the solstice — thank you, Lord, for the solstice,” she said. “I really need [the medication] now, but I may not in the spring and summer.”

But now, in when the days are their shortest, SAD puts a crimp on the holidays.

“It kills Christmas,” said Saratsiotis. “I sit in the middle of the department store with that particular song about the sleigh bells ringing, and I am sobbing. I burst into tears and think, ‘Just kill that song.’”

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The Medical Guide to Holiday Movies

Anna Karenina lies febrile on her post-partum bed, her husband, Karenin, and lover, Vronsky, flanking her in sorrow. She repents to each, anticipating her end, and just when the romance soars to its peak, you wonder aloud — why does she have a fever? And, could this really happen?

Luckily, we’ve got Hollywood’s holiday ailments covered. Our unofficial disease guide takes a shot at unraveling the medical mysteries you’ll see woven throughout the biggest hits of the season.

Medical Guide to Holiday Movies

Denzel Washington plays a drug-addicted, alcoholic airline pilot who executes a miracle crash landing but is later blamed for the incident.

ALCOHOLISM

It turns out that drinking and flying is relatively rare. But that wasn’t true in the 1960s. A landmark article on aviation and alcohol found that in 35 percent of all fatal airline accidents in 1963, the pilots had measurable levels of alcohol in their blood. A disproportionate amount of these accidents occurred at night and most occurred within the first half-hour of flight.

So how does alcohol affect flight performance? One scientific article reports that blood alcohol concentrations in the range of 0.03 to 0.05-percent can impair performance of tasks like tracking radio-frequency signals, airport traffic control vectoring, traffic observation and avoidance, and aircraft descent. That’s about the amount present after just one drink for an average size adult.

POST-TRAUMATIC STRESS SYNDROME (PTSD)

According to the book, Aviation Mental Health, pilots may be at risk for PTSD if they’ve ever experienced an aircraft mishap or near mishap. Because of this, the airline industry has a program in place called the Critical Incident Response Program that guides pilots through any potential PTSD inciting events. In addition to this, Federal law requires that all airline employees and their families have access to such counseling programs when faced with significant incidents like aircraft accidents.

When it comes to needing medication however, pilots face a double-edged sword. While counseling services for psychiatric conditions like PTSD are not reportable to the FAA, the use of certain medications is. Pilots are required to report use of any psychotropic medications beyond common antidepressants and refrain from flying until they are medication-free.

Medical Guide to Holiday Movies

Daniel Day-Lewis and Sally Field recreate the spirit of America’s first power couple and highlight the staggering height difference between Abe and Mary Todd.

MARFAN SYNDROME

At 6 feet, 4 inchesl, Abe Lincoln towered nearly 9 inches taller than the average 1860s man. Like a taupe, tailless Na’vi from the movie Avatar, his long legs and spidery fingers intimidated adversaries near and far. But his stately frame was more than just a normal variant. Historians have speculated that Lincoln was afflicted with a rare genetic disorder called Marfan syndrome. The disorder affects connective tissues in the body, causing skeletal abnormalities, and problems with the heart, eyes, and lungs. In addition to being extraordinarily tall, people with Marfan’s are often lanky, with long, slender limbs (dolichostenomelia) and fingers (arachnodactyly).

Some experts argue however that Lincoln instead had a condition called multiple endocrine neoplasia type 2, or MEN2. People with this disorder can also be unusually tall. Either way, his condition would have gone unnamed during his lifetime as Dr. Antoine Marfan, the French pediatrician who first described the condition, didn’t do so until 1896—well after President Lincoln’s untimely death.

Medical Guide to Holiday Movies

Keira Knightly stars in yet another period piece, this time portraying Leo Tolstoy’s beloved, Anna Karenina — a 19th century Russian aristocratic beauty caught in a nasty love triangle.

ENDOMETRITIS

Shortly after giving birth, Karenina experiences a high-grade fever that sends both her lovers to their knees, anticipating the worst. Puerperal fever, or endometritis as it’s now called, was known historically as “the doctor’s plague.” With no concept of germs, doctors often had no reason to wash their hands before attending to births. As such, they often precipitated such post-partum infections, giving thousands of women a simultaneous childbed and deathbed.

Other famous victims include Elizabeth of York, King Henry VIII’s mother, and his third wife, Jane Seymour. It is worth noting that, with the advent of antibiotics and modern-day hygiene, the chances of dying from a post-partum infection today are now incredibly rare.

Medical Guide to Holiday Movies

An all-star cast brings this classic tale of love and loss to the big screen this Christmas Day. And given its historical precedence, we’ll assume we’re not spoiling too much by first announcing Fantine’s death before diving into an explanation of the disease that kills her.

TUBERCULOSIS

Was there ever a more culturally documented medical affliction than consumption, or tuberculosis as it’s known medically? Perhaps not, and that’s why we see so many references to it in popular literature, music and film. Les Miserables is the latest creation to highlight the devastating effects of an infectious disease still commonly seen in third world countries.

TB is a contagious bacterial infection that attacks the lungs and less commonly, other organs. It causes fever, night sweats, weight loss, and sometimes hemetemesis—the coughing up of blood. It’s no wonder that folklore has often associated this disease with vampirism. An article in the American Journal of Physical Anthropology reports that prior to the Industrial Revolution, people interpreted the subsequent deaths of TB patients’ family members as proof that the initial victim was draining them of their lives. In other words, patient zero coughed up blood and therefore, was a vampire.

Today, some countries vaccinate against tuberculosis with a strain of the live, but weakened form of bacteria that infects cows. The vaccine works for only a limited amount of time and its efficacy is limited by geographic region. In the U.S., doctors screen only high risk populations like health care workers and recent immigrants.

Medical Guide to Holiday Movies

Bilbo Baggins returns in this prequel to Lord of the Rings, leading a group of dwarves on a riveting adventure through Middle Earth.

DWARFISM

Is it the hobbits that are really short or the elves that really tall? It’s all relative when it comes to height. If we assume however, that hobbits truly are little people, then it’s safe to say this is a generalized condition that’s associated with upwards of 200 different medical conditions. Either way, the National Institutes of Health defines a dwarf as someone of very short stature — usually under 4’10″ as an adult. Almost 70 percent of all dwarfism cases are due to a condition called achondroplasia, which is a genetic disorder affecting up to 1 in 15,000 people.

Dwarfism itself is not a disease and most little people go on to live healthy, long, and normal lives. Historical prejudice however, often led to their stigmatization as a different kind of being. During the Holocaust, the Nazis went so far as to conduct medical experiments on little people. A shocking example of this was German doctor Josef Mengele’s human zoo — a collection of different looking Jewish prisoners, including a family of dwarves called the Ovitzes.

OBSESSIVE COMPULSIVE DISORDER (OCD)

Greedy little Gollum exhibits the classic signs and symptoms of obsessive compulsive disorder. His obsession with the One Ring is concerning for an all-consuming, socially isolating disorder that nearly 1.5 percent of Americans experience. OCD is an anxiety disorder that causes repetitive, unwanted thoughts or behaviors, often plaguing its victims on a daily basis.

Luckily for patients with OCD, there are many treatment options available. Whether or not Gollum can access these in Middle Earth is an entirely different issue.

Medical Guide to Holiday Movies

Vampires are not real… or are they?

PORPHYRIA

In 1963, an article from the Proceedings of the Royal Society of Medicine entitled, “On Porphyria and the Aetiology of Werwolves” made the case for real life creatures of the night. The paper argued that these so-called beasts were, in fact, humans suffering from congenital prophyria. It references run-ins with these creatures by Pliny, Herodotus, and Virgil, and even offers photographic evidence of the scarring and mutilated human faces that could easily be mistaken for beast.

In 1985, biochemist David Dolphin furthered this association with his widely popularized scientific paper, “Porphyria, Vampires, and Werewolves: The Aetiology of European Metamorphosis Legends.” Not surprisingly, medical experts criticize this and other references for being both fake and promoting of an anti-porphyria stigma.

Porphyria itself is a disorder of the enzymes involved in red blood cell production. It causes neurologic complications and skin problems when affected people are exposed to light. Photosensitivity, blisters, itching, and swelling are just some of the symptoms that no doubt led to a corollary to vampirism. But if sun causes your skin to peel off, doesn’t it make sense that you’d avoid daylight?

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South Africa’s Mandela to remain in hospital for Christmas

JOHANNESBURG (Reuters) – Former South African President Nelson Mandela continues to respond to treatment more than two weeks after being taken to hospital in Pretoria and will remain there for Christmas Day, the presidency said on Monday.

The 94-year-old anti-apartheid hero and Nobel Peace laureate has been treated for a lung infection and gallstones after being hospitalized on December 8.

President Jacob Zuma said in a statement that Mandela “will recover from this episode with all our support… We also humbly invite all freedom loving people around the world to pray for him.”

It will be the first Christmas that Mandela has spent away from home since 1989, when he was still in prison. He was jailed for almost three decades for his role in the struggle against white minority rule.

He was released in 1990 and went on to use his prestige to push for reconciliation between whites and blacks as the bedrock of the post-apartheid “Rainbow Nation”.

Mandela was elected South Africa‘s first black president in 1994. He stepped down five years later after one term in office and has been largely removed from public life for the last decade.

(Reporting and writing by Ed Stoddard; Editing by Stella Mapenzauswa and Tom Pfeiffer)

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Former President George H.W. Bush remains hospitalized

(Reuters) – Former President George H.W. Bush, who has been hospitalized for a month undergoing treatment for bronchitis, may not be released from a Houston hospital in time to celebrate Christmas at home as doctors had hoped.

Bush, 88, remained in stable condition and doctors were optimistic he would make a full recovery, George Kovacik, a spokesman at Methodist Hospital, said in an emailed statement on Sunday.

But doctors were being “extra cautious” with his care and no discharge date had been set, the statement said. Earlier this month, Kovacik said doctors expected Bush would be able to spend Christmas at home with his family.

“His doctors feel he should build up his energy before going home,” the statement said.

Bush, the 41st president and a Republican, took office in 1989 and served one term in the White House. The father of former President George W. Bush, he also is a former congressman, U.N. ambassador, CIA director and vice president for two terms under Ronald Reagan.

(Reporting by Kevin Gray; Editing by Daniel Trotta and Vicki Allen)

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Long-lived bats offer clues on diseases, aging

HONG KONG (Reuters) – The bat, a reservoir for viruses like Ebola, SARS and Nipah, has for decades stumped scientists trying to figure out how it is immune to many deadly bugs but a recent study into its genes may finally shed some light, scientists said on Friday.

Studying the DNA of two distant bat species, the scientists discovered how genes dealing with the bats’ immune system had undergone the most rapid change.

This may explain why they are relatively free of disease and live exceptionally long lives compared with other mammals of similar size, such as the rat, said Professor Lin-Fa Wang, an infectious disease expert at the Duke-NUS Graduate Medical School in Singapore who led the multi-centre study.

“We are not saying bats never get sick or never get infections. What we are saying is they handle infections a lot better,” Wang said in a telephone interview.

What was missing from both species of bats was a gene segment known to trigger extreme, and potentially fatal, immune reactions to infections, called the cytokine storm.

Cytokine storms end up killing not only offending viruses in the body, but the host’s own cells and tissues too.

“Viruses rarely kill the host. The killing comes from the host’s immune response. So it looks like what bats are doing is depress the inflammation (cytokine storm). If we can learn that, we can design drugs to minimize the inflammation damage and control viral infection,” Wang said.

The study, which saw the participation of researchers from China, Denmark, Australia and the United States, was published on Friday in the journal Science.

Compared with other mammals of similar size, bats live a long time, with lifespans of between 20 and 40 years. Rats live between 2 and 3 years, on average.

IMMUNE GENES LINKED TO FLIGHT

Interestingly, Wang and his colleagues found that the highly evolved genes that give bats their superior immune system also enable them to fly.

Out of more than 5,000 types of mammals on the planet, bats are the only one capable of sustained flight and some species can fly more than 1,000 km in a single night.

Such intense physical exertion is known to produce toxic “free radicals” that cause tissue damage and it is these same genes that give the bat the ability to repair itself, Wang said.

“What we found was the genes that evolved fastest were genes involved in repairing DNA damage. That makes sense … because when you fly, metabolism goes up and it generates free radicals that are toxic to cells,” Wang said.

“Because bats fly, they (would have had) to evolve and adapt … to get genes that can repair DNA damage.”

Wang said we have much to learn from the bat, which has evolved to avoid disease and live exceptionally long lives.

“Cancer, ageing and infectious disease, these are the three major areas of concern for people,” he said.

“We have studied rats for 150 years to understand how to do better in these three areas. Now we have a system, the bat, that has done very well in evolution. We can learn from the bat. With modern techniques, we can design new drugs to slow down the ageing process, treat cancer, fight infections.”

(Editing by Robert Birsel)

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Firms spend less to pitch to kids, foods slightly better: U.S. FTC

WASHINGTON (Reuters) – Food companies spent considerably less to advertise to children in 2009 than they did in 2006, although the foods that were pitched were only slightly more nutritious, the U.S. Federal Trade Commission said in a report out on Friday.

The FTC, in a survey of data from industry, found that companies spent $ 1.79 billion to advertise to children aged 2 to 17 in 2009, down almost 20 percent, on an inflation-adjusted basis, from $ 2.1 billion three years earlier.

But that drop came not because companies were advertising less, necessarily, but because they were switching from more expensive television advertising to online marketing, the FTC said.

The FTC also found “modest nutritional improvements” in the foods advertised to children, in categories including cereals, drinks and fast-food kid’s meals.

(Reporting By Diane Bartz)

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Alliance Health Networks Brings Prominent HCV Clinical Trials Leader, Dr. Peter Ruane, to Hepatitis Connect Social Network

SALT LAKE CITY–(BUSINESS WIRE)–

Alliance Health Networks, the leading social networking company serving consumers and the healthcare industry, today announced the addition of Dr. Peter Ruane, prominent HIV and HCV clinical trials doctor and founder of Lightsource Medical, as a new community advocate on the Hepatitis Connect social network.

Hepatitis Connect is part of Alliance Health’s growing portfolio of social networks currently serving more than 1.5 million registered users across some 50 condition-specific sites. Hepatitis Connect aims to empower people infected with HCV to more actively manage their health through personal connections, powerful tools, and quality resources. Community and patient advocates offer network members deep insights and experience dealing with a particular disease or condition.

“From the beginning, our top priority at Alliance Health has been to create an online community that provides actionable information with a personal touch, and one of the ways we accomplish that is through our patient advocates,” said Dan Hickey, senior vice president of product at Alliance Health Networks. “What is so fascinating in the case of Dr. Ruane is that he was a physician in the clinical trial that led to a successful outcome for John Lavitt, our patient advocate at Hepatitis Connect. It adds a new dimension by demonstrating that a clinical trial can have a meaningful impact on a person’s life today, not just down the road.”

A specialist in infectious diseases and HIV medicine, Dr. Ruane has been conducting clinical trials for HIV since 1992, many of which have shifted to new HCV drugs and HCV-HIV trials to find co-existing regimens to simultaneously treat both conditions.

Deaths from Hepatitis C have increased steadily in the United States in recent years, in part because many people don’t know they’re infected. In fact, according to 1999 to 2007 data reviewed by the Centers for Disease Control and Prevention, more Americans have died from HCV than from HIV. Unlike HIV, Hepatitis C is curable. With rapidly advancing results coming from research and clinical trials with new drugs that target the virus directly, there is great hope.

“Patients are already gaining considerable benefits from the new regimens of protease inhibitors that were approved in 2011 by the FDA,” said Dr. Ruane. “But these drugs are just the beginning. On Hepatitis Connect, I hope to keep the community up-to-date on the new options, especially clinical trials as they become available and offer my thoughts on trials in general and why participating in a clinical trial may be a good choice for a person to make.”

As Patient Advocate for Hepatitis Connect, John Lavitt is proud to have Dr. Ruane on board as part of the community’s team. “When I went through the clinical trial with Dr. Ruane,” explained Lavitt, “his support and expertise helped me survive the difficult challenges and come out the other side of a tough experience that changed my life forever and for the better.”

About Alliance Health Networks

Alliance Health Networks is building a free and independent social engagement platform that gives people the power to navigate their personal health journey. The company owns and operates more than 50 social networks and 20 mobile versions serving over 1.5 million registered members. Alliance Health leverages social networks to help consumers more actively manage their care through personal connections, powerful tools, and deeper insights. The company’s investors include New World Ventures, Physic Ventures, Highway 12 Ventures, EPIC Ventures and Voyager Capital. For more information, visit: www.alliancehealthnetworks.com.

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Two cups of milk daily enough for most kids: study

NEW YORK (Reuters Health) – Two cups of cow’s milk per day may be enough for most kids to have the recommended amount of vitamin D in their blood while maintaining a healthy iron level, suggests a new study.

“One of the common questions I get from parents when their kids become toddlers is, ‘how much milk should they be drinking?’ But we didn’t have a good answer,” said Dr. Jonathon Maguire, the study’s lead author from Toronto’s TARGet Kids! Collaboration.

One reason for the confusion, according to the researchers, is the American Academy of Pediatrics (AAP) recommends children between 2 and 8 years old drink two cups of milk per day, but in another guideline, the organization also says children need supplemental vitamin D if they drink less than four cups per day.

The researchers write in the journal Pediatrics that previous studies showed cow’s milk increases the amount of vitamin D in a child’s blood while also reducing iron levels. Iron, which the body can get from meats and beans, is important for developing brains and protecting against anemia.

Vitamin D, which is naturally produced in the body during sun exposure, helps the body absorb calcium and prevents the bone-softening disease rickets. People also get the vitamin by eating fortified foods, such as milk and fatty fish.

Maguire, a pediatrician at Toronto’s St. Michael’s Hospital, and his colleagues surveyed the parents of 1,311 children, who were between 2 and 5 years old and at pediatricians’ offices in the Toronto area between December 2008 and December 2010. They also took blood samples from the children.

The researchers found one cup (250 milliliters) of milk was tied to a 5 nanomoles per liter (nmol/L) increase of vitamin D in the children’s blood, and a small decrease in iron levels.

The Canadian Pediatric Society suggests children maintain a vitamin D level in their blood of at least 75 nmol/L. On average, the children were drinking just under two cups of milk per day, and were exceeding their recommended vitamin D level.

The researchers concluded that two glasses of cow’s milk per day is enough to keep most kids at the suggested vitamin D levels while also maintaining a healthy amount of iron.

SUPPLEMENTS AND OTHER SOURCES

That’s not a blanket suggestion for all children, however.

Maguire and his colleagues say darker skinned children may need 3 to 4 cups of milk per day during the winter, when their bodies produce less vitamin D naturally from sun exposure.

Maguire told Reuters Health that the findings seem consistent with previous recommendations.

“I don’t think there is too much cause for concern. I think this is probably old news for some parents,” he said.

Patsy Brannon, a professor of nutritional sciences at Cornell University in Ithaca, New York, said the finding of 2 cups of milk is consistent with the U.S. Department of Agriculture’s recommendation for two and three year olds, but said older children need 2.5 cups.

Also, she points out, the U.S. Institutes of Medicine and AAP recommend a vitamin D level in children of at least 50 nmol/L, which is lower than the Canadian society’s suggestion.

Currently, the AAP recommends infants, children and teens get 400 international units (IU) of vitamin D per day. The average cup of milk has about 100 IU of vitamin D.

Brannon recommends taking a daily vitamin D supplement to reach that recommendation, but adds that people can also get the vitamin from fortified cereals, grains and other foods.

“There are other sources of vitamin D in the diet besides what comes from milk. We have to be concerned about excessive milk consumption in this age group,” she said.

SOURCE: http://bit.ly/T568Dc Pediatrics, online December 17, 2012.

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Shire’s ADHD amphetamine wins British backing

LONDON (Reuters) – Shire‘s hyperactivity treatment Vyvanse will be available in Europe within months after Britain’s drugs regulator backed the amphetamine-based stimulant used to treat millions of U.S. students.

The drug, lisdexamfetamine dimesylate, has a slow-release action that activates the amphetamine ingredient over the course of a day, helping levels of alertness and concentration in children with ADHD (attention deficit hyperactivity disorder).

It was assessed under the European Union‘s decentralized approvals procedure, led by Britain’s medicines watchdog. The application was supported by two European studies and clinical data from the United States.

Seven other EU countries – Denmark, Finland, Germany, Ireland, Norway, Spain and Sweden – participated, and they have agreed product labels. They will now issue their own national approvals, a process that takes up to three months, Shire said.

Chief executive Angus Russell said: “As all ADHD patients are different and will vary in their responses to the available treatments, we believe introducing Elvanse will provide physicians with a broader range of options to help patients with ADHD manage their individual needs effectively”.

Shire has established a leading position in treating hyperactivity in the United States with its stimulants Adderall XR and Vyvanse. The latter saw sales rise 24 percent to $ 247 million in the three months to September.

Shore Capital analyst Brian White said while he had modest sales expectations in the short term for the drug in Europe, where it will be the first amphetamine to be approved for ADHD, the decision was significant because the condition was becoming better known in Europe.

“Shire has been very successful in the U.S. with its ADHD franchise and one would expect them to use that experience to do a similar job in Europe, although that will take a lot longer just given the much lower awareness,” he said.

“They have another product coming along later (Intuniv) which is a non-stimulant, and that could be more appropriate for the European market than a stimulant.”

Vyvanse, which Shire said was the top-selling branded prescribed ADHD medicine in the United States, has been indicated in Europe for ADHD in children aged six years and over when treatment with methylphenidate, better known as Ritalin, was not successful.

(Editing by Dan Lalor)

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Pediatricians call to keep thimerosal in vaccines

(Reuters Health) – A mercury-containing preservative rarely used in the United States should not be banned as an ingredient in vaccines, U.S. pediatricians said Monday, in a move that may be controversial.

In its statement, the American Academy of Pediatrics (AAP) endorsed calls from a World Health Organization (WHO) committee that the preservative, thimerosal, should not be considered a hazardous source of mercury that could be banned by the United Nations.

The AAP in 1999 asked for its removal from vaccines in the United States because of a concern that youngsters receiving multiple shots containing thimerosal might get too much mercury – and develop autism or other neurodevelopmental problems, despite the lack of hard evidence at the time.

“It was absolutely a matter of precaution because of the absence of more information,” said Dr. Louis Cooper, from Columbia University in New York, who was on the organization’s board of directors at the time.

“Subsequently an awful lot of effort has been put into trying to sort out whether thimerosal causes any harm to kids, and the bottom line is basically, it doesn’t look as if it does,” he said.

In a 2004 safety review, for example, the independent U.S. Institute of Medicine concluded there was no evidence thimerosal-containing vaccines could cause autism. A study by the Centers for Disease Control and Prevention came to the same conclusion in 2010.

With the exception of some types of flu shots, the compound is not used in vaccines in the United States, which are distributed in single-dose vials.

And nobody is arguing that should change, according to Dr. Walter Orenstein, a member of the AAP Committee on Infectious Diseases and a researcher at the Emory Vaccine Center in Atlanta.

But in countries with fewer resources – where many children still die of vaccine-preventable diseases – it is cheaper and easier to use multi-dose vials of vaccines against diphtheria and tetanus, for example.

Thimerosal prevents the rest of a multi-dose vial from getting contaminated with bacteria or fungi each time a dose is used.

Researchers estimated it could cost anywhere from two to five times as much to manufacture vaccines for developing countries without thimerosal, and both transporting vaccines and keeping them refrigerated would also be much harder.

“We’re having a hard time completing the task of getting every kid immunized now. That would add a tremendous burden,” Cooper said, adding that more children would probably die as a result.

Children who can now be protected from these life-threatening diseases could become vulnerable, Orenstein told Reuters Health.

The new statement is published in the AAP’s journal Pediatrics.

Thimerosal contains a type of mercury called ethyl mercury. Toxic effects have been tied to its cousin, methyl mercury, which stays in the body for much longer.

Earlier this year, the WHO said replacing thimerosal with an alternative preservative could affect vaccine safety and might cause some vaccines to become unavailable.

Mercury, however, is still on the list of global health hazards to be banned in a draft treaty from the United Nations Environment Program – which would mean a ban on thimerosal.

Reducing mercury exposure “is a wonderful thing,” Orenstein said.

However, “We need this exception because thimerosal is so vital for protecting children.”

For the Pediatrics document, please see: bit.ly/cxXOG

(Editing by Christine Soares, Nick Zieminski)

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Child deaths and bitter cold in Syrian refugee camps

ZAATARI, Jordan (Reuters) – One-year-old Ali Ghazawi, born with a heart defect, faced a battle for survival even before his family fled Syria‘s civil war. It was a struggle he lost two weeks ago in the bitter winter cold of a tented refugee camp in north Jordan.

Ali died two days after undergoing a heart operation in Zaatari camp, which houses at least 32,000 refugees who escaped fierce bombardment in Syria’s rebellious southern province of Deraa, cradle of the uprising against President Bashar al-Assad.

“I covered my son with two blankets, but he was not warming up, and he turned blue before he passed away in my hands,” said his sobbing 22-year-old mother, alone with a three-year-old daughter after she left her husband in Deraa and crossed the border in November.

Ali was the fourth baby to die in three weeks in the windswept camp. United Nations aid workers say none of the deaths were the direct result of conditions in Zaatari, yet they highlight the challenge facing relief agencies scrambling to provide basic shelter for half a million refugees in the region.

“These deaths are a result of cumulative factors, some related to shortage in needs and natural causes. But on top of that, the reality that conditions are harsh cannot be ignored,” said Saba Mobaslat, program director at Save the Children.

Jordan, Lebanon and Turkey each host more than 130,000 registered refugees, and relief workers predict the numbers will only increase as violence escalates around the capital Damascus.

Mirroring Syria’s youthful population, almost 65 percent of Jordan’s camp residents are newborns and young children.

“Every night we are getting children as young as four days old, six days old, one week, two weeks old, and it’s a real struggle to try to make sure that everyone survives,” said Andrew Harper, Jordan head of the United Nations High Commissioner for Refugees (UNHCR).

“Women are giving birth on the border, and people are coming across pregnant. It’s a situation where we just need to redouble efforts, particularly as we move into winter, because you have hundreds of pregnant women who cross the border,” Harper said.

Families often send the most vulnerable to safety, he added, so alongside the very young in Zaatari are many older refugees. “Last night we had a couple who were 97 years old,” he said.

“CHILDREN’S CAMP”

Along the main road in the middle of the camp’s muddy and gravel streets, children of all ages race around the makeshift market place that sprang up after the camp opened in July.

Many families join in, out of enterprise or necessity, selling everything from hot falafel to household goods, old clothing and fresh vegetables.

“It’s a children’s camp. You walk into it and there are children everywhere. It’s in your face. The male adults are staying behind, and a woman comes with 10 children without her bread earner,” Mobaslat added.

In one of several UNICEF-run playgrounds, among seesaws, swings and volunteers giving music lessons, the scars of war are fresh in the minds of most children.

“I long for my home, and I hope Bashar falls to get back to my home. It’s much better than here, where we are humiliated,” said Mohammad Ghazawi, 12, who came to play after a break from selling cheap cigarettes.

Their elders complain that two thin blankets per refugee distributed in recent weeks were not enough to warm them in tents that let in rain water despite zinc reinforcements and waterproof layers that have helped insulate them.

“Kids are dying from cold and lack of blankets. My kids shiver at night, and one has constant diarrhea,” said Mohammad Samara, 46, who fled heavy shelling in the southern Syrian town of Busr al-Sham in October with his wife and four children.

Carsten Hansen, country director for the Norwegian Refugee Council (NRC), which has set up a heated tent that receives families on arrival, says much progress has been made to help distribute aid.

“Everybody is trying to mobilize resources … in order to react to bigger numbers and a huge influx,” Hansen said, adding that 6,000 gas heaters had been airlifted to Jordan to help heat the tent camp.

FROM CRISIS TO DISASTER?

Harper said UNHCR was working to prevent “this humanitarian crisis becoming a major disaster”. But he said that while aid teams were racing to improve conditions at Zaatari, there were 100,000 other registered refugees living outside the camp and probably another 100,000 unregistered, whose living conditions were not improving.

In Lebanon, too, host to 154,000 refugees, many face a bleak winter, and aid workers expect their numbers to more than double by the middle of next year.

In the Bekaa Valley town of Bar Elias, a woman from the northern Syria province of Idlib says her home for the last year has been a wooden shack with only plastic sheeting to protect from the rain. Plastic bags are stuffed into the roof as extra insurance against leaks. “There is no water, no electricity, no school for my kids,” she said in a croaky voice.

“My husband is sick. The situation is very bad.”

Mads Almaas, NRC country director in Lebanon, said many more may flee Syria over the winter to escape worsening conditions there, putting even greater strain on relief efforts.

“The violence will not only continue but also get worse. And even in the increasingly likely event of the fall of Assad, we don’t think the violence will end,” he said.

Almaas said the United Nations would launch a regional response plan on Wednesday anticipating a total of 300,000 registered refugees in Lebanon by mid-2013. “At first we thought it was too high. Now we are concerned it is too low,” he said.

In Turkey, which hosts 136,000 refugees, camps for the most part have facilities such as portable electric heaters, and refugees receive three hot meals a day from the Red Crescent. But temperatures can plunge below freezing in the rugged terrain along the 900 kilometer (560 mile) border with Syria during the winter months, and rain can be torrential and cause flooding.

Overcrowding remains a concern, with extended families cramped in single tents and ever more refugees arriving as fighting across the border drags on.

Across the region, aid workers fear an explosion in violence could leave them seriously overstretched.

“Right now funds are sufficient. What is a challenge is if we get any shocks, something like 5,000-10,000 refugees arriving (in Lebanon) in a matter of hours,” Almaas said.

If fighting swept through the center of Damascus, thousands of Syrians could flee to the Lebanese border in a matter of hours. “For that, we are not prepared as the NRC. I also question the international community’s capacity.”

(Additional reporting by Oliver Holmes in Beirut and Nick Tattersall in Ankara; Editing by Dominic Evans and Will Waterman)

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S.Africa’s Mandela had gall stones removed, recovering: govt

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APNewsBreak: Texas cancer probe draws NCI scrutiny

AUSTIN, Texas (AP) — The federal National Cancer Institute says it’s taking a fresh look at a troubled $ 3 billion cancer-fighting effort already being scrutinized by prosecutors and lawmakers in Texas.

The U.S. government’s cancer research agency confirmed Friday that upheaval within the Cancer Prevention and Research Institute of Texas caught its attention. NCI spokeswoman Aleea Farrakh Khan told The Associated Press that officials are “evaluating recent events” at CPRIT.

CPRIT is on an exclusive list of NCI-approved funding entities, which includes the American Cancer Society. The designation is a federal seal-of-approval that signals high peer review standards and conflict of interest policies.

Khan says NCI has made no decisions about CPRIT or contacted the agency directly.

Prosecutors are investigating CPRIT following an $ 11 million award to a private company that bypassed review.

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Fewer cancer patients pick CPR after video demo

NEW YORK (Reuters Health) – Dying cancer patients are less likely to want aggressive end-of-life care if they watch a short video about CPR than if they simply hear about it, according to a new study.

“These are huge differences. You will die very differently if you watch the video than if you don’t,” said Dr. Angelo Volandes, the study’s lead author from Boston’s Massachusetts General Hospital.

“All these patients had a terminal condition. It’s not like there was another treatment they were trying…So (CPR) was prolonging the dying process,” he said.

The researchers found in a group of 150 cancer patients, who were thought to have less than a year to live, 48 percent wanted CPR after being told about it, compared to 20 percent in the group who also watched a video showing compressions on a dummy and the inserting of a breathing tube.

“It’s one of the most important issues in American medicine today. People are getting medical interventions that, if they had more knowledge, they would simply not want,” said Volandes.

The new study builds off previous research with similar findings by the same group. The earlier research, however, was only conducted with brain cancer patients at one medical center.

For the new study, published in the Journal of Clinical Oncology, the researchers included a wider variety of cancer patients at four medical centers in Massachusetts, New York and Tennessee.

All of the patients who agreed to participate in the study were read a standardized description of CPR — described as pressing on their chest and using an electric shock to “get your heart to beat again if it stops.”

The description also said CPR does not revive most patients with advanced cancer, and the patient would likely be put in the ICU with a breathing machine if it worked.

The researchers then randomly selected 70 of the patients to watch a three-minute video demonstration.

In the group that was only told about CPR, about half of the 80 patients said they wouldn’t want doctors or nurses to revive them. That compared to 79 percent of the patients who also watched the video.

Nine out of every ten patients who watched the video also said it was “helpful.”

PART OF A BIGGER CONVERSATION

Volandes told Reuters Health that the video may reinforce the information patients usually get from their doctors.

“People aren’t clinicians. They don’t have clinic experience to understand what this looks like,” he said.

Dr. Susan Gaeta, an assistant professor at The University of Texas MD Anderson Cancer Center in Houston, told Reuters Health she likes the idea of using the videos, but said they need to be part of a bigger conversation.

“What we’re trying to do is to have conversation with patients on what their goals and values are,” said Gaeta.

She added that the question should not be, “Do you want this?” It should be, “Is this medically appropriate based on your goals and values?”

Volandes said their collection of 25 videos on various topics, including CPR and breathing tubes, are used by over 30 healthcare systems across the country.

Gaeta added that her hospital is developing their own videos that incorporate their focus of goals and values.

SOURCE: http://bit.ly/TP4qV1 Journal of Clinical Oncology, online December 10, 2012.

Diseases/Conditions News Headlines – Yahoo! News

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