Mediterranean diet can ward off heart disease: study

NEW YORK (Reuters Health) – A Mediterranean diet high in olive oil, nuts, fish and fresh fruits and vegetables may help prevent heart disease and strokes, according to a new large study from Spain.

Past research suggested people who eat a Mediterranean-like diet have healthier hearts, but those studies couldn’t rule out that other health or lifestyle differences had made the difference.

For the new trial, researchers randomly assigned study volunteers at risk of heart disease to a Mediterranean or standard low-fat diet for five years, allowing the team to single out the effect of diet, in particular.

“This is good news, because we know how to prevent the main cause of deaths – that is cardiovascular disease – with a good diet,” said Dr. Miguel Angel Martinez-Gonzalez, who worked on the study at the Universidad de Navarra in Pamplona.

He and colleagues from across Spain assigned almost 7,500 older adults with diabetes or other heart risks to one of three groups.

Two groups were instructed to eat a Mediterranean diet – one supplemented with extra-virgin olive oil and the other with nuts, both donated for the study – with help from personalized advice and group meetings. The third study group ate a “control” diet, which emphasized low-fat dairy products, grains and fruits and vegetables.

Over the next five years, 288 study participants had a heart attack or stroke or died of any type of cardiovascular disease.

People on both Mediterranean diets were 28 to 30 percent less likely to develop cardiovascular disease than those on the general low-fat diet, the researchers reported Monday in the New England Journal of Medicine.

The new study is the first randomized trial of any diet pattern to show benefit among people initially without heart disease, said Dr. Dariush Mozaffarian, who studies nutrition and cardiovascular disease at the Harvard School of Public Health in Boston.

NOT DUE TO SINGLE INGREDIENT

It’s the blend of Mediterranean diet components – not one particular ingredient – that promotes heart health, according to Martinez-Gonzalez.

“The quality of fat in the Mediterranean diet is very good,” he told Reuters Health. “This good source of calories is replacing other bad sources of calories. In addition, there is a wide variety of plant foods in the Mediterranean diet,” including legumes and fruits as desserts, Martinez-Gonzalez added.

“I think it’s a combination of what’s eaten and what’s not eaten,” agreed Mozaffarian, who wasn’t involved in the new research.

“Things that are discouraged are refined breads and sweets, sodas and red meats and processed meats,” he told Reuters Health. “The combination of more of the good things and less of the bad things is important.”

Martinez-Gonzalez suggested people seeking to improve their diet start with small changes, such as forgoing meat one or two days per week, cooking with olive oil and drinking red wine with meals rather than hard alcohol.

Replacing a high-carbohydrate or high-saturated fat snack with a handful of nuts is also a helpful change, said Teresa Fung, a nutrition researcher at Simmons College in Boston who also wasn’t on the study team.

“All of these steps are making, at the end of the day, a big difference,” Martinez-Gonzalez said.

Fung pointed out many people in the new trial were already on medications, such as statins and diabetes drugs.

“The way I see it is, even if people are on medication already, diet has substantial additional benefit,” she told Reuters Health.

That’s likely the case for people without heart risks – including high blood pressure or cholesterol – as well, Fung added.

“This is a high-risk group, but I don’t think people should wait until they become high-risk in order to change,” she said.

SOURCE: http://bit.ly/YuyV7v New England Journal of Medicine, online February 25, 2013.

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Mediterranean diet can ward off heart disease: study

NEW YORK (Reuters Health) – A Mediterranean diet high in olive oil, nuts, fish and fresh fruits and vegetables may help prevent heart disease and strokes, according to a new large study from Spain.

Past research suggested people who eat a Mediterranean-like diet have healthier hearts, but those studies couldn’t rule out that other health or lifestyle differences had made the difference.

For the new trial, researchers randomly assigned study volunteers at risk of heart disease to a Mediterranean or standard low-fat diet for five years, allowing the team to single out the effect of diet, in particular.

“This is good news, because we know how to prevent the main cause of deaths – that is cardiovascular disease – with a good diet,” said Dr. Miguel Angel Martinez-Gonzalez, who worked on the study at the Universidad de Navarra in Pamplona.

He and colleagues from across Spain assigned almost 7,500 older adults with diabetes or other heart risks to one of three groups.

Two groups were instructed to eat a Mediterranean diet – one supplemented with extra-virgin olive oil and the other with nuts, both donated for the study – with help from personalized advice and group meetings. The third study group ate a “control” diet, which emphasized low-fat dairy products, grains and fruits and vegetables.

Over the next five years, 288 study participants had a heart attack or stroke or died of any type of cardiovascular disease.

People on both Mediterranean diets were 28 to 30 percent less likely to develop cardiovascular disease than those on the general low-fat diet, the researchers reported Monday in the New England Journal of Medicine.

The new study is the first randomized trial of any diet pattern to show benefit among people initially without heart disease, said Dr. Dariush Mozaffarian, who studies nutrition and cardiovascular disease at the Harvard School of Public Health in Boston.

NOT DUE TO SINGLE INGREDIENT

It’s the blend of Mediterranean diet components – not one particular ingredient – that promotes heart health, according to Martinez-Gonzalez.

“The quality of fat in the Mediterranean diet is very good,” he told Reuters Health. “This good source of calories is replacing other bad sources of calories. In addition, there is a wide variety of plant foods in the Mediterranean diet,” including legumes and fruits as desserts, Martinez-Gonzalez added.

“I think it’s a combination of what’s eaten and what’s not eaten,” agreed Mozaffarian, who wasn’t involved in the new research.

“Things that are discouraged are refined breads and sweets, sodas and red meats and processed meats,” he told Reuters Health. “The combination of more of the good things and less of the bad things is important.”

Martinez-Gonzalez suggested people seeking to improve their diet start with small changes, such as forgoing meat one or two days per week, cooking with olive oil and drinking red wine with meals rather than hard alcohol.

Replacing a high-carbohydrate or high-saturated fat snack with a handful of nuts is also a helpful change, said Teresa Fung, a nutrition researcher at Simmons College in Boston who also wasn’t on the study team.

“All of these steps are making, at the end of the day, a big difference,” Martinez-Gonzalez said.

Fung pointed out many people in the new trial were already on medications, such as statins and diabetes drugs.

“The way I see it is, even if people are on medication already, diet has substantial additional benefit,” she told Reuters Health.

That’s likely the case for people without heart risks – including high blood pressure or cholesterol – as well, Fung added.

“This is a high-risk group, but I don’t think people should wait until they become high-risk in order to change,” she said.

SOURCE: http://bit.ly/YuyV7v New England Journal of Medicine, online February 25, 2013.

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Mediterranean diet can ward off heart disease: study

NEW YORK (Reuters Health) – A Mediterranean diet high in olive oil, nuts, fish and fresh fruits and vegetables may help prevent heart disease and strokes, according to a new large study from Spain.

Past research suggested people who eat a Mediterranean-like diet have healthier hearts, but those studies couldn’t rule out that other health or lifestyle differences had made the difference.

For the new trial, researchers randomly assigned study volunteers at risk of heart disease to a Mediterranean or standard low-fat diet for five years, allowing the team to single out the effect of diet, in particular.

“This is good news, because we know how to prevent the main cause of deaths – that is cardiovascular disease – with a good diet,” said Dr. Miguel Angel Martinez-Gonzalez, who worked on the study at the Universidad de Navarra in Pamplona.

He and colleagues from across Spain assigned almost 7,500 older adults with diabetes or other heart risks to one of three groups.

Two groups were instructed to eat a Mediterranean diet – one supplemented with extra-virgin olive oil and the other with nuts, both donated for the study – with help from personalized advice and group meetings. The third study group ate a “control” diet, which emphasized low-fat dairy products, grains and fruits and vegetables.

Over the next five years, 288 study participants had a heart attack or stroke or died of any type of cardiovascular disease.

People on both Mediterranean diets were 28 to 30 percent less likely to develop cardiovascular disease than those on the general low-fat diet, the researchers reported Monday in the New England Journal of Medicine.

The new study is the first randomized trial of any diet pattern to show benefit among people initially without heart disease, said Dr. Dariush Mozaffarian, who studies nutrition and cardiovascular disease at the Harvard School of Public Health in Boston.

NOT DUE TO SINGLE INGREDIENT

It’s the blend of Mediterranean diet components – not one particular ingredient – that promotes heart health, according to Martinez-Gonzalez.

“The quality of fat in the Mediterranean diet is very good,” he told Reuters Health. “This good source of calories is replacing other bad sources of calories. In addition, there is a wide variety of plant foods in the Mediterranean diet,” including legumes and fruits as desserts, Martinez-Gonzalez added.

“I think it’s a combination of what’s eaten and what’s not eaten,” agreed Mozaffarian, who wasn’t involved in the new research.

“Things that are discouraged are refined breads and sweets, sodas and red meats and processed meats,” he told Reuters Health. “The combination of more of the good things and less of the bad things is important.”

Martinez-Gonzalez suggested people seeking to improve their diet start with small changes, such as forgoing meat one or two days per week, cooking with olive oil and drinking red wine with meals rather than hard alcohol.

Replacing a high-carbohydrate or high-saturated fat snack with a handful of nuts is also a helpful change, said Teresa Fung, a nutrition researcher at Simmons College in Boston who also wasn’t on the study team.

“All of these steps are making, at the end of the day, a big difference,” Martinez-Gonzalez said.

Fung pointed out many people in the new trial were already on medications, such as statins and diabetes drugs.

“The way I see it is, even if people are on medication already, diet has substantial additional benefit,” she told Reuters Health.

That’s likely the case for people without heart risks – including high blood pressure or cholesterol – as well, Fung added.

“This is a high-risk group, but I don’t think people should wait until they become high-risk in order to change,” she said.

SOURCE: http://bit.ly/YuyV7v New England Journal of Medicine, online February 25, 2013.

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Mediterranean diet can ward off heart disease: study

NEW YORK (Reuters Health) – A Mediterranean diet high in olive oil, nuts, fish and fresh fruits and vegetables may help prevent heart disease and strokes, according to a new large study from Spain.

Past research suggested people who eat a Mediterranean-like diet have healthier hearts, but those studies couldn’t rule out that other health or lifestyle differences had made the difference.

For the new trial, researchers randomly assigned study volunteers at risk of heart disease to a Mediterranean or standard low-fat diet for five years, allowing the team to single out the effect of diet, in particular.

“This is good news, because we know how to prevent the main cause of deaths – that is cardiovascular disease – with a good diet,” said Dr. Miguel Angel Martinez-Gonzalez, who worked on the study at the Universidad de Navarra in Pamplona.

He and colleagues from across Spain assigned almost 7,500 older adults with diabetes or other heart risks to one of three groups.

Two groups were instructed to eat a Mediterranean diet – one supplemented with extra-virgin olive oil and the other with nuts, both donated for the study – with help from personalized advice and group meetings. The third study group ate a “control” diet, which emphasized low-fat dairy products, grains and fruits and vegetables.

Over the next five years, 288 study participants had a heart attack or stroke or died of any type of cardiovascular disease.

People on both Mediterranean diets were 28 to 30 percent less likely to develop cardiovascular disease than those on the general low-fat diet, the researchers reported Monday in the New England Journal of Medicine.

The new study is the first randomized trial of any diet pattern to show benefit among people initially without heart disease, said Dr. Dariush Mozaffarian, who studies nutrition and cardiovascular disease at the Harvard School of Public Health in Boston.

NOT DUE TO SINGLE INGREDIENT

It’s the blend of Mediterranean diet components – not one particular ingredient – that promotes heart health, according to Martinez-Gonzalez.

“The quality of fat in the Mediterranean diet is very good,” he told Reuters Health. “This good source of calories is replacing other bad sources of calories. In addition, there is a wide variety of plant foods in the Mediterranean diet,” including legumes and fruits as desserts, Martinez-Gonzalez added.

“I think it’s a combination of what’s eaten and what’s not eaten,” agreed Mozaffarian, who wasn’t involved in the new research.

“Things that are discouraged are refined breads and sweets, sodas and red meats and processed meats,” he told Reuters Health. “The combination of more of the good things and less of the bad things is important.”

Martinez-Gonzalez suggested people seeking to improve their diet start with small changes, such as forgoing meat one or two days per week, cooking with olive oil and drinking red wine with meals rather than hard alcohol.

Replacing a high-carbohydrate or high-saturated fat snack with a handful of nuts is also a helpful change, said Teresa Fung, a nutrition researcher at Simmons College in Boston who also wasn’t on the study team.

“All of these steps are making, at the end of the day, a big difference,” Martinez-Gonzalez said.

Fung pointed out many people in the new trial were already on medications, such as statins and diabetes drugs.

“The way I see it is, even if people are on medication already, diet has substantial additional benefit,” she told Reuters Health.

That’s likely the case for people without heart risks – including high blood pressure or cholesterol – as well, Fung added.

“This is a high-risk group, but I don’t think people should wait until they become high-risk in order to change,” she said.

SOURCE: http://bit.ly/YuyV7v New England Journal of Medicine, online February 25, 2013.

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More proof Mediterranean diet can ward off heart disease

(Reuters) – A Mediterranean diet high in olive oil, nuts, fish and fresh fruits and vegetables may help prevent heart disease and strokes, according to a large study from Spain.

Past research suggested people who eat this type of diet have healthier hearts, but those studies couldn’t rule out that other health or lifestyle differences had made the difference.

But for the new trial, written up in the New England Journal of Medicine, researchers randomly assigned study volunteers at risk of heart disease to a Mediterranean or standard low-fat diet for five years, allowing the team to single out the effect of diet in particular.

“This is good news, because we know how to prevent the main cause of deaths – that is cardiovascular diseases – with a good diet,” said Miguel Angel Martinez-Gonzalez, who worked on the study at the Universidad de Navarra in Pamplona.

He and colleagues from across Spain assigned almost 7,500 older adults with diabetes or other heart risks to one of three groups.

Two groups were instructed to eat a Mediterranean diet – one supplemented with extra-virgin olive oil and the other with nuts, both donated for the study – with help from personalized advice and group meetings. The third study group ate a “control” diet, which emphasized low-far dairy products, grains and fruits and vegetables.

Over the next five years, 288 study participants had a heart attack or stroke, or died of any type of cardiovascular disease.

People on both Mediterranean diets, though, were 28 to 30 percent less likely to develop cardiovascular disease than those on the general low-fat diet, the researchers said.

The new study is the first randomized trial of any diet pattern to show benefit among people initially without heart disease, said Dariush Mozaffarian, who studies nutrition and cardiovascular disease at the Harvard School of Public Health.

It’s the blend of Mediterranean diet components, and not one particular ingredient, that promotes heart health, according to Martinez-Gonzalez.

“The quality of fat in the Mediterranean diet is very good,” he told Reuters Health. “This good source of calories is replacing other bad sources of calories. In addition, there is a wide variety of plant foods in the Mediterranean diet,” he added, including legumes and fruits as desserts.

He suggested that people seeking to improve their diet start with small changes, such as forgoing meat one or two days a week, cooking with olive oil and drinking red wine with meals rather than hard alcohol.

Replacing a high-carbohydrate or high-saturated fat snack with a handful of nuts is also a helpful change, experts said.

“I think it’s a combination of what’s eaten and what’s not eaten,” said Mozaffarian, who wasn’t involved in the study. “Things that are discouraged are refined breads and sweets, sodas and red meats and processed meats.

“The combination of more of the good things and less of the bad things is important.”

Teresa Fung, a nutrition researcher at Simmons College in Boston, said that many people in the trial were already on medications, such as statins and diabetes drugs.

“The way I see it is, even if people are on medication already, diet has substantial additional benefit,” she added. “This is a high-risk group, but I don’t think people should wait until they become high-risk in order to change.” SOURCE: http://bit.ly/YuyV7v

(Reporting from New York by Genevra Pittman at Reuters Health; editing by Elaine Lies)

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Stretches that Make you Look and Feel Taller

Feb 24, 2013 9:11am

Katie’s Take

“Sit up straight!”  A meme that is easier said than done! But the benefits of straightening up can have a lasting effect on our bodies and minds.

Katie Couric sat down with Tara Stiles, named “Yoga Rebel” by the New York Times and owner of Strala Yoga, to talk about how simple stretches can help our bodies, minds and make us feel and look taller.

Yoga, an exercise that allows increased blood flow through stretching and deep breathing, has been practiced for over 5000 years and practiced by 11 million Americans. Yoga isn’t just for the contortionists; according to Stiles all it requires is deep breathing.

By taking in large breaths, tension in our muscles is released which Stiles says helps aids in overall health from in the inside out. She calls yoga a ‘massage for our organs’ that encourages us to live a healthier and happier lifestyle while increasing our flexibility and strengthening our muscles.

And the great thing is, you don’t have to seek out a yoga studio to take advantage of the benefits. Stiles showed Katie’s some simple stretches that people can do while sitting at their desks or even watching TV.  By taking a few minutes to stretch throughout the day, you can release tension in your body and lengthen your muscles so you can look and feel taller. So straighten up and take a deep breath, you will feel and see a difference immediately.

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Horsemeat with banned drug entered French food chain

PARIS (Reuters) – Meat from three horse carcasses contaminated with a banned drug has entered the human food chain in France but there is no danger to the public, the French farm minister said on Saturday.

The meat, which came from a lot of six British carcasses exported to France, contained traces of phenylbutazone – known as bute – an anti-inflammatory painkiller for sporting horses, banned for animals intended for eventual human consumption.

French Agriculture Minister Stephane Le Foll said there was no danger to public health. “One would have to eat 500 horse hamburgers every day in order to run a risk,” he told reporters at the Paris farm show.

The six carcasses arrived in January at a firm in northern France that specializes in horse meat products. Three were intercepted in time.

Earlier this month, Britain’s Food Standards Agency (FSA) said six horses slaughtered in the UK that tested positive for phenylbutazone were exported to France.

(Reporting by Sybille de la Hamaide and Elizabeth Pineau; Writing by Geert De Clercq; Editing by Jon Hemming)

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Herbalife recalls some Nutritional Shake Mix due to milk allergen

(Reuters) – Herbalife Ltd said on Friday it was recalling some of its Nutritional Shake Mix because although the label said it was dairy free it may contain “trace amounts” of milk proteins.

The company said in a statement that people with severe allergies to milk run the risk of serious or life-threatening allergic reaction if they consume products containing milk proteins.

Herbalife said there had been no reports to date of any illnesses or adverse health effects associated with the affected products and that it had notified the U.S. Food and Drug Administration.

The company, which sells products through a network of independent distributors, said the product was distributed in the United States from January 16, 2013, through February 16, 2013, exclusively to individual independent distributors as cartons of 12 packets or as single-serving packets in the company’s introductory business pack. It said the lot numbers were 133405G10, 133408G10, and 133409G10.

Independent distributors were being contacted by telephone and U.S. mail to alert them to the recall, the company said.

(Reporting by Neha Alawadhi in Bangalore)

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Most women misunderstand IUD birth control

NEW YORK (Reuters Health) – In a new survey, most women had inaccurate perceptions about the safety and effectiveness of intrauterine devices (IUDs) in preventing pregnancy, say U.S. researchers, who urge doctors to talk more about the benefits of the devices.

In particular, many of the study participants didn’t know that IUDs are more effective contraceptives than the birth control pill and that the devices don’t increase the risk of getting a sexually transmitted disease.

“It’s not clear whether women have an overly optimistic view of the effectiveness of the birth control pill or an overly pessimistic view of the IUD,” said Dr. Lisa Callegari, the study’s lead author and a clinical assistant professor at the University of Washington.

Whatever their source, these misperceptions lead to underuse of “one of the most safe and effective methods” of birth control, said Dr. Jeffrey Peipert, an obstetrics and gynecology professor at Washington University, who was not part of the study.

IUDs, which include the brand name products ParaGard and Mirena, are small plastic or copper-and-plastic objects inserted into the uterus. They can be left implanted for years, and are more than 99 percent effective at preventing pregnancy.

In contrast, the birth control pill has been found in real-world practice to be about 95 percent effective.

Callegari said that earlier studies have highlighted some of the mistaken beliefs women have about IUDs, and she and her colleagues wanted to get a better sense of how common they are among average women visiting primary care clinics.

They surveyed more than 1,600 women between the ages of 18 and 50 who had visited one of four clinics in Pennsylvania.

Five percent of the women were currently using an IUD, and another 5.8 percent had used one previously.

Only about one in five of the women correctly stated that IUDs are more effective at preventing pregnancy than the Pill.

And just 28 percent knew that an IUD is more cost effective than the Pill when it is used for more than three years, the researchers report in the medical journal Contraception.

According to Planned Parenthood, the upfront costs of an IUD are between $ 500 and $ 1,000, whereas birth control pills can cost between $ 15 and $ 50 a month – so they become more expensive over time.

The women in the study were considerably more knowledgeable about the risk of disease related to an IUD, with 57 percent answering correctly that there is no greater risk of contracting a sexually transmitted disease with an IUD compared to the Pill.

Still, Peipert said he’s not surprised that women might view IUDs less favorably.

“There’s been a LOT of bad press about IUDs in the past,” Peipert wrote in an email to Reuters Health.

For instance, thousands of women have sued the makers of the Dalkon Shield, an IUD sold in the 1970s, because of injuries sustained from infections.

“It’s not surprising, because of the history of the IUD in the United States, that people still have inaccurate perceptions of the device,” said Dr. Rebecca Allen, an assistant professor of obstetrics and gynecology at Brown University, who was not involved in the study.

Currently available devices are considered to be much safer, said Allen.

Indeed, women over age 36 tended to have more misperceptions than younger women who took the survey, the researchers note in their report.

It’s likely, too, that many women are simply not as familiar with the devices as they are with the Pill, said Callegari.

According to a 2012 study by the Centers for Disease Control and Prevention (CDC), 28 percent of women of reproductive age use oral contraception, making the Pill the most common form of birth control, followed closely by sterilization methods like getting the fallopian tubes “tied,” used by 27 percent of women.

The same CDC study found that IUD use had risen from 0.8 percent of reproductive-age women in 1995 to 5.6 percent in 2010.

To correct widespread misconceptions about IUDs, Allen said, health care providers should be encouraged to talk to their patients about the devices.

Among women who have never used an IUD, Callagari’s study found that those who had been counseled about the device by a health care provider were more knowledgeable than women who hadn’t discussed it.

“I think it helps to give more evidence that providers should be talking with patients about IUDs,” she told Reuters Health. “Women hear it and it affects their perceptions.”

Providers themselves might need to be educated too, however.

One recent survey of physicians found that 30 percent had outdated ideas about IUDs, including thinking they are unsafe for women who had never had a baby or being unsure about their safety (see Reuters Health story of March 28, 2012 here: http://reut.rs/HhJ0dH).

“We need to educate more primary care providers about the facts about IUDs so that they can counsel their patients,” said Allen.

SOURCE: http://bit.ly/XP6lK8 Contraception, online February 18, 2013.

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Antioxidants may not ward off strokes, dementia

NEW YORK (Reuters Health) – Older adults who eat diets high in antioxidants may not have a lower risk of dementia or stroke, a new study suggests.

Researchers found that people who ate or drank lots of coffee, tea, oranges and red wine were just as likely to develop neurological problems over the next 14 years as those who skimped on antioxidant-rich foods.

“The literature on antioxidants and dementia has been mixed,” said Elizabeth Devore, who led the new research at Brigham and Women’s Hospital in Boston.

Although there’s some evidence that specific vitamins have a protective effect in the brain, she said it’s unclear whether that’s the case for all antioxidants – which include vitamin C, vitamin E, selenium and flavonoids.

“There is the thought that overall antioxidants might be helpful, but it’s also true that if you actually look at the individual antioxidants, there’s not necessarily a reason to think that one would behave exactly the same way in the body as the next.”

The Netherlands-based study included 5,395 people aged 55 years and older, who reported their usual consumption of 170 different foods in 1990.

Devore and her colleagues tracked those participants over the next 14 years, during which 599 were diagnosed with dementia – including 484 with Alzheimer’s disease – and 601 had a first stroke.

People who consumed the most antioxidants, according to an analysis of their diets, were just as likely to end up having either of those neurological disorders as study participants who hardly got any antioxidants.

That pattern held after the researchers took into account people’s ages, how much they ate in general and whether they smoked, according to the findings published Wednesday in Neurology.

There was also no link between total dietary antioxidants and white or gray matter volume in the brain, according to scans done on 462 of the participants.

Since the study looked only at foods consumed, it can’t address whether antioxidant supplements may impact dementia or stroke risk, according to Devore.

Her team concludes that it’s still likely certain individual antioxidants have positive effects on the brain.

“There have been a number of studies that have shown that higher intake of dietary vitamin E is associated with lower risk of dementia,” Devore told Reuters Health. The same goes for vitamin C and stroke risk, she added.

That suggests people should continue eating plenty of fruits and vegetables, including berries, and seek out specific antioxidants, she said.

“For dementia specifically and stroke specifically, if you’re worried about those… you should try to take in vitamin E for dementia and vitamin C for stroke.”

SOURCE: http://bit.ly/csS3ol Neurology, online February 20, 2013.

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Police dog “sniff” passes Supreme Court smell test

WASHINGTON (Reuters) – The U.S. Supreme Court ruled on Tuesday that “the sniff is up to snuff” in a Florida case on how police may use dogs to track down illegal drugs.

In a unanimous decision, the Supreme Court gave law enforcement authorities greater authority to use dogs to uncover illegal drugs, upholding a police dog’s search of a truck that uncovered methamphetamine ingredients inside.

The justices said that training records had established the reliability of Aldo, a German shepherd, in sniffing out contraband, and that Florida’s Supreme Court erred in suppressing evidence he found in Clayton Harris‘ pickup truck.

“The question – similar to every inquiry into probable cause – is whether all the facts surrounding a dog’s alert, viewed through the lens of common sense, would make a reasonably prudent person think that a search would reveal contraband or evidence of a crime,” Justice Elena Kagan wrote for the court. “A sniff is up to snuff when it meets that test.”

Harris’ case is one of two the court is considering this term about the validity of evidence obtained by drug-sniffing dogs. A decision has yet to be issued in the second case.

Tuesday’s decision could make it easier for police to use dogs to sniff for drugs without first having to show with great specificity how well-trained the dogs were.

The court has often allowed dog searches, including of luggage at airports and cars at checkpoints. Harris‘ case has been watched closely by criminal defense advocates.

INCENTIVE TO TRAIN

A Liberty County, Florida, K-9 officer named William Wheetley had allowed Aldo a “free air sniff” outside Harris’ truck during a June 2006 traffic stop, after the defendant had appeared nervous and refused to consent to a search inside.

Harris’ lawyers challenged the search, questioning whether Aldo’s certification and performance showed that he was reliable in sniffing out drugs.

But Florida’s Supreme Court concluded that the state had not sufficiently established how well-trained Aldo was, or how reliable his nose was.

It therefore ruled the evidence of the methamphetamine ingredients should not have been admitted against Harris, who pleaded no contest but was given a right to appeal.

Kagan, however, wrote that Wheetley reasonably believed there was contraband inside the truck based on Aldo’s training, and that Harris failed to show that Aldo was unreliable.

She said it was enough that a dog’s “satisfactory performance” in a certification or training program provided sufficient reason for an officer to trust its alert, even though errors “may abound” when dogs get put to the test in the field.

“Law enforcement units have their own strong incentive to use effective training and certification programs, because only accurate drug-detection dogs enable officers to locate contraband without incurring unnecessary risks or wasting limited time and resources,” Kagan wrote.

Glen Gifford, a public defender representing Harris, did not immediately respond to a request for comment.

Gregory Garre, a former U.S. solicitor general representing Florida, said, “We’re very pleased with the decision.”

SEARCHING INSIDE A HOME

The other dog sniff case, also from Florida, focused on a search on the doorstep of a home by a chocolate Labrador retriever, Franky, who had a strong record of sniffing out drug stashes. The search uncovered marijuana growing inside.

During oral arguments in October, several justices expressed concern that searches uncovering illegal drugs inside homes could infringe the expectations of privacy that people have there, and which might not exist elsewhere.

In 2001, a divided U.S. Supreme Court banned the police’s use of thermal imaging technology from afar to peer inside homes, because they could uncover things that deserved privacy.

The case is Florida v. Harris, U.S. Supreme Court, No. 11-817.

(Reporting by Jonathan Stempel; Editing by Howard Goller and Doina Chiacu)

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Arkansas Senate passes bill to ban abortions after 20 weeks

LITTLE ROCK, Arkansas (Reuters) – The Republican-controlled Arkansas state Senate approved a measure on Monday to ban abortions after 20 weeks of pregnancy except in the case of rape, incest or to save the mother’s life.

The Pain Capable Unborn Child Protection Act passed the Senate, 25-7, with amendments that allowed for the exemptions in the case of rape or incest. An earlier version of the bill that passed the Republican-controlled House allowed exemptions only for pregnancies that threatened the mother’s life.

The bill, which shortens the existing limit of 25 weeks, now returns to the House for consideration of the Senate amendment.

Democratic Governor Mike Beebe has not said whether he would sign the bill into law.

Seven U.S. states have laws that restrict or ban abortion after the 20-week mark and similar laws approved in Arizona and Georgia are facing legal challenges.

Late-term abortions remain relatively rare. Most of the recent state laws banning most abortions after 20 weeks are based on hotly debated medical research suggesting a fetus feels pain starting at 20 weeks of gestation.

(Reporting by Suzi Parker; Editing by Daniel Trotta and Dale Hudson)

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Study says IVF does not increase cancer risk

(Reuters) – Women getting fertility treatments can be reassured that in vitro fertilization (IVF) does not increase their risk of breast and gynecological cancers, according to a U.S. study of Israeli women.

“The findings were fairly reassuring. Nothing was significantly elevated,” said lead author Louise Brinton, chief of the Hormonal and Reproductive Epidemiology Branch at the National Cancer Institute in Rockville, Maryland.

Ovulation-stimulating drugs or puncturing of the ovaries to retrieve eggs can be part of IVF treatments, procedures that researchers have suspected may increase women’s risk of cancer. Indeed, previous studies did link IVF early in life to heightened risks of breast cancer and borderline ovarian tumors.

But other studies have found little connection between fertility treatments and cancer.

The association has been difficult to untangle, experts say, in part because it’s hard to know whether unmeasured factors not realized to IVF may affect the risk of cancer in women who have trouble conceiving. In addition, so far there haven’t been a lot of women who developed cancer after fertility treatment included in studies.

“We all want answers, but it’s a very difficult exposure to study, particularly when we don’t have the numbers we would really like,” Brinton, whose results appeared in the journal Fertility & Sterility, told Reuters Health.

She and her colleagues examined the medical records of 67,608 women who underwent IVF treatments between 1994 and 2011 and 19,795 women who sought treatment but never received IVF.

The researchers linked those files to a national cancer registry and found 1,509 of them had been diagnosed with cancer through mid-2011.

There was no difference in women’s chances of being diagnosed with breast or endometrial cancer based on whether they were treated with IVF. The researchers did find that a woman’s risk of ovarian cancer slightly increased the more rounds of treatment she received, but that finding could have been due to chance.

Brinton said her study was too small conclusively link IVF and ovarian cancer – and that it remained very rare, with 45 cases in the entire study.

A similar association was found in a study headed by Bengt Kallen, director of the Tornblad Institute at Lund University, Sweden, who said that any increased ovarian cancer risk might be due to the dysfunctional ovaries themselves.

“Infertile women have a primary problem with their ovaries and IVF has nothing to do with it,” Kallen told Reuters Health. “It’s a rather difficult thing to disentangle if there is an effect from the hormones or from the IVF procedure.”

Others warned of biases that may make the results of studies like this difficult to interpret, nothing that women undergoing IVF are watched very closely, which would likely increase the chance that ovarian cancers are detected.

“You have to be extraordinarily cautious about this kind of a study,” said Sherman Silber of the Infertility Center of St. Louis. “If anything. It’s reassuring. One doesn’t see any real increase in cancer.” SOURCE: http://bit.ly/vkUVAO

(Reporting from New York by Trevor Stokes at Reuters Health; editing by Elaine Lies)

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Pistorius, girlfriend were planning future – uncle

JOHANNESBURG, Feb 16 (Reuters) – South African athlete Oscar Pistorius was planning a future with his girlfriend Reeva Steenkamp, who he is accused of murdering, his uncle said on Saturday.

“They had plans together and Oscar was happier in his private life than he had been for a long time,” his uncle Anthony Pistorius said in a statement.

Pistorius has been charged with the premeditated murder of Steenkamp on Thursday. He denies it.

(Reporting by Ed Cropley; Editing by Angus MacSwan)

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Catholic bishops ask Congress for contraceptives reprieve

WASHINGTON (Reuters) – U.S. Roman Catholic bishops stepped up their battle against President Obama‘s contraceptives policy on Friday by urging Congress to use its fiscal debate to free religious employers from a mandate requiring insurance coverage for birth control.

In a letter to all 535 members of Congress, Archbishop William Lori of Baltimore suggested two provisions to extend existing federal conscience protections to the contraceptives mandate and strengthen the ability of opponents to seek vindication in federal court.

“The federal government‘s respect for believers and people of conscience no longer measures up to the treatment Americans have a right to expect from their elected representatives,” wrote Lori, who chairs the Ad Hoc Committee on Religious Liberty of the U.S. Conference of Catholic Bishops.

“I urge you in the strongest terms possible to incorporate the provisions … in the upcoming legislative proposals to fund the federal government,” Lori added.

The conference also plans to send out an action alert via email and text message calling on supporters across the country to visit local congressional offices next week when lawmakers are home on break.

Obama’s 2010 Patient Protection and Affordable Care Act requires employers to provide health insurance coverage through group coverage plans for all contraceptives approved by the U.S. Food and Drug Administration, including the so-called “morning after” pill.

The archbishop’s letter underscored a growing sense of urgency among church leaders over the birth control coverage rules that are due to take effect on August 1 for religiously affiliated employers including universities, hospitals and charities.

The bishops have tried several times to get Congress to act over the past year, amid numerous protests and more than 40 lawsuits by religious groups and employers. But Lori’s letter marks their first attempt to use the debates over deficit reduction, the debt limit and government funding.

“To many people, this looks like the main must-pass vehicle going through Congress this year,” said Richard Doerflinger, associate director of the conference’s Secretariat of Pro-Life Activities.

The new healthcare law contains an exemption for houses of worship but has come under attack from Catholic leaders, Protestant Evangelicals and other social conservatives who also want religious nonprofit organizations and religious business owners exempted.

The Catholic Church regards contraception as a sin and birth control products like the morning-after pill a form of abortion. In a development that could intensify the debate, the U.S. Centers for Disease Control reported this week that growing numbers of American women are using the morning-after pill.

The Obama administration offered its opponents a compromise on February 1 by proposing new regulations that would allow religious employers to avoid paying for birth control coverage for their workers. Instead, insurers would provide the benefits free through separate coverage plans.

The president of the bishops conference, Cardinal Timothy Dolan of New York, rejected the plan as inadequate last week.

Doerflinger said church efforts to get favorable language on contraceptives included in funding legislation follows a congressional precedent for including conscience provisions in appropriations bills in the U.S. House of Representatives.

But he acknowledged that the bishops could face an uphill fight on Capitol Hill. “The pressure everywhere is for just trying to address the money issues,” he said. “That’s why we need to remind members of Congress that these issues of fundamental rights are also pending and won’t go away.”

(Reporting by David Morgan; Editing by Ros Krasny and Paul Simao)

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Seasonal Flu on the Downswing in Oklahoma

The influenza season typically peaks in the months of January and February, according to statistics compiled by the U.S. Centers for Disease Control and Prevention since the 1982-1983 flu season. The 2012-13 season began in earnest a few weeks earlier in this current season; perhaps Oklahoma‘s current decrease in newly reported cases in mid-February demonstrates that continued trend of the peak of the flu season occurring within so many days/weeks after the onset for that year.

Oklahoma Influenza Statistics for Feb. 3 through Feb. 9

The Oklahoma State Department of Health , OSDH, releases updated statistics about influenza in the state each Thursday during the flu season. The most recent data available is for the one-week period ending Feb. 9.

Since the 2012-13 flu season began Sept. 30, 862 people have been hospitalized in Oklahoma with influenza; 25 people have died. People age 65 and older have represented the largest single age group to be hospitalized with influenza at 442 of the 862 total hospitalizations. Those age 65 and older also represented the largest single age group to die from complications of the flu, representing 20 of the 25 total deaths. Two people died from flu complications in this latest reported week ,one each from Nowata and Washington counties.

An OSDH graph shows that patient visits for influenza-like illnesses to monitored clinicians have continued to decline since the third week of January. Another graph shows that the actual number of positive tests for influenza have declined in the last two weeks.

Influenza Symptoms

Sometimes it can be difficult to know if you are sick with a cold or the flu, since both have respiratory signs and symptoms. The National Institute of Allergy and Infectious Diseases offered these comparisons:

* Influenza : Sudden onset; usually a fever that lasts three to four days; headache; general aches and pains, often severe; exhaustion at the beginning of illness, followed by weakness and fatigue that can last three to four weeks; may sometimes have stuffy nose, sneezing and/or sore throat.

* Cold : Gradual onset; rarely a fever; slight general aches and pains; sometimes fatigue and weakness; never exhaustion; often stuffy nose and sore throat and may be sneezing.

The possible complications of these two viral illnesses differ in severity. Complications from having the common cold may be middle ear infection, sinus congestion and/or asthma. Complications from seasonal influenza may be bronchitis, pneumonia, worsening of already existing chronic conditions and can be life-threatening.

Contagious Period of Seasonal Flu

The CDC explained that a healthy person can spread the seasonal flu to other people for one day before flu symptoms are even noticed and up to five to seven days after symptoms have begun. Young children and people with compromised immune systems may remain contagious for a longer period of time.

Considering this timeline for the ability to infect others with the flu, if you become ill with the flu, avoid unnecessary contact with others until the contagious period has passed.

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Who Pays the Highest Price When It Comes to Breast Cancer?

In this, the third in our month-long series on the disparities and inequities of cancer in the U.S. and beyond, we look at the group of American women hardest hit—by far—when it comes to breast cancer.

One in nine women will have breast cancer. The disease is the second-leading cause of death among women in the United States. But no group suffers more from breast cancer than African-American women.

According to the Centers for Disease Control and Prevention (CDC):

•   African-American women have the highest death rate from breast cancer of all races/ethnicities. They are 40 percent more likely to die of the disease than white women.

•   Forty-five percent of black women are found to have breast cancer that has spread beyond the breast (when it has reached a far deadlier stage) compared with 35 percent of white women.

•   After learning that their mammogram is not normal, 20 percent of black women wait or delay seeing a doctor for follow-up more than 60 days. That’s compared to 12 percent of white women. Waiting longer for follow-up care may allow cancer to spread.

Have Cancer but No Insurance? No Problem — You Can Pay With Your Life

•   Only 69 percent of black women start treatment within 30 days of their diagnosis of breast cancer, compared with 83 percent of white women.

•   Overall, breast cancer death rates among U.S. women fell 27 percent from 1990 to 2005, but not at equal rates. In white women, breast cancer mortality declined by 2.5 percent annually, but it declined just 1.4 percent each year for African-American women.

•   Fewer black women receive the surgery, radiation, and hormone treatments they need compared to white women.

Like other types of cancer disparities, the reasons that black women have worse survival rates are numerous. They include poverty, lack of access to care, lack of health insurance, literacy barriers, and unequal treatment by professionals in the healthcare system, according to a March 2002 Institute of Medicine report.

“A lot of the same reasons for disparities that we see in other types of cancers come into play here—less access to care; less access to screening technologies; not receiving the same kinds of treatments and follow-up care,” says Dr. David Wetter, a professor in the department of Health Disparities Research, Division of Cancer Prevention and Population Sciences, at the University of Texas MD Anderson Cancer Center, in Houston.

But there are also differences in the types of breast cancer among various racial and ethnic groups. “African-American and Hispanic women seem to get a more aggressive form of cancer and at a younger age—the ‘triple negative’ breast cancer. It’s a more virulent form of cancer with worse outcomes,” Wetter says. A “triple negative” breast cancer means the cancer cells do not have receptors for the hormones estrogen or progesterone or high levels of the HER2/neu protein. These levels can tell an oncologist how quickly the breast cancer might grow.

One Group Dies From Cancer More Often Than Any Other. Do You Know Who It Is?

The good news is that black women get mammograms about as often as white women, according to the CDC.

Still, everyone—from government to public health departments to doctors to women themselves—need to take more steps to erase breast-cancer disparities affecting black women, experts say. The Affordable Care Act is a good start. Under the new law, women who have no ability to pay can still get a mammogram.

Even better, the National Breast and Cervical Cancer Early Detection Program provides screenings and diagnostic services to low-income, uninsured, and underinsured women. Click on the “Find a Screening Provider” tab on the program’s site to arrange for your mammogram.

Black women should also get regular physical exams and discuss their risk of breast cancer with a health professional. The Agency for Healthcare Research and Quality has a list of questions for women to use to improve communication with a doctor about tests like mammograms.

What more do you think should be done to lower breast cancer rates among African-American women?  

Related Stories on TakePart:

• So You Think Obamacare is Radical? Take a Look at China

• Breast Cancer Innovations

• Confused About Donating to Breast Cancer Causes? Here’s How to Pink Straight

---

Shari Roan is an award-winning health writer based in Southern California. She is the author of three books on health and science subjects.

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CNN’s Sanjay Gupta adds fiction to his workload

LOS ANGELES (AP) — When doctors get called on the carpet by other doctors, it’s productive but not always pretty, as neurosurgeon Sanjay Gupta describes it.

Closed-door meetings in which physicians candidly dissect cases that went awry can verge on “dignified versions of street fights,” said CNN’s globe-trotting correspondent.

He drew on such sessions — commonplace for hospitals, if little publicly known — for his first novel, “Monday Mornings,” and is a writer-producer on a new TNT series based on the 2012 book.

The drama, from veteran producer David E. Kelley (“Boston Legal,” ”The Practice”) and with a heavyweight cast that includes Ving Rhames, Alfred Molina and Bill Irwin, debuts Monday (10 p.m. EST). That’s also the day the show’s fictional Chelsea General Hospital holds its weekly reviews.

In the real world, such meetings to scrutinize complications and mistakes in patient care can lead to new guidelines, Gupta said.

“They can be simple, like never sedate a patient until they’re strapped in on the table,” he said, the outcome of an unrestrained patient having taken a tumble. “Some changes are big, some are small, but they are always important. We are always redefining medicine.”

In the first episode of “Monday Mornings,” brash but dedicated neurosurgeon Dr. Tyler Wilson (Jamie Bamber, “Battlestar Galactica”) is grilled for failing to check a patient’s medical history. Gupta said he learned his own “searing” lesson, about carefully reviewing lab results, without any harm to the patient.

Do the forums ever become a stage for office politics?

“People do jockey for position in these situations,” Gupta replied. “If someone’s at the lectern (under scrutiny), anyone can ask questions, not just the chairperson of the department. So the nature and tone of it can change pretty quickly.”

The most disturbing inquiries involve an apparently reckless M.D. with “a disregard for the person on the operating table or in the hospital,” he said. “You can imagine your own mother or loved in the position of the patient, and those are the most indelible ones of all.”

The meetings make for gripping drama on “Monday Mornings.” But is a show that focuses on medicine’s failures as well as its triumphs potentially a hard sell for audiences?

“ER,” TV’s once-reigning hospital drama, aired a powerful first-season episode in which decisions by Dr. Mark Greene, the caring, steady lead character played by Anthony Edwards, cost a pregnant woman her life. The story line was a rarity on the show that routinely focused on medical heroics.

The key to making the TNT series work is the “likability” of its physicians, said Bill D’Elia, a producer on “Monday Mornings.”

It’s crucial to “understand their motivation, understand how good they are, how much they care. So it’s not black-and-white” when a character blows it, D’Elia said.

As is the case with non-TV doctors, Gupta said.

A mistake is made and “you think that’s a bad doctor. You may even think that’s a bad human being, and in some cases you might be right,” he said. “But a lot of times you’re not, and I think showing the rest of the story, how it may continue to get discussed” is illuminating.

Besides writing for “Monday Mornings,” Gupta, 43, makes sure it depicts surgery and the world of medicine accurately.

How Gupta fits the tasks into his already demanding schedule is a medical mystery. As D’Elia said, he never knows if he’s talking to the doctor in Atlanta, where Gupta lives with his family and practices, or in another city, sometimes far-flung, as part of his award-winning work for CNN (which, like TNT, is part of Time Warner subsidiary Turner).

“When I talk to him I have this (mental) picture of him in front of a green screen so he can input wherever he is,” D’Elia said. “He’s as likely to be in Pakistan as New York.”

Since joining CNN in 2001, Gupta has covered events including the quake and tsunami in Japan, Hurricane Katrina and the Gulf of Mexico oil disaster. In 2003, while embedded with a Navy medical unit, he reported from Iraq and Kuwait and acted as a doctor as well as a reporter, performing brain surgeries in a desert operating room.

That same year, he got a spot on People magazine’s list of the “sexiest men alive.”

He anchors the weekend medical affairs program, “Sanjay Gupta MD,” is on the staff and faculty at the Emory University School of Medicine in Atlanta, and is an associate chief of neurosurgery at Grady Memorial Hospital.

In 2009, he was approached for the position of surgeon general in the new Obama administration, a post he says he declined because it would have halted his work as a neurosurgeon. He’s said he’s a supporter of the Affordable Care Act and wants to see it fully implemented to give more Americans coverage.

Gupta learned his work ethic from his parents, who moved from India in the 1960s to work at a Ford plant in Detroit, where he grew up, and is surprised when people ask how he does it all.

“There’s a lot of people who work a lot harder than I do and aren’t known,” he said.

___

Online:

http://www.tntdrama.com

___

Lynn Elber can be reached at lelber(at)ap.org and on Twitter (at)lynnelber.

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Need surgery? Good luck getting hospital cost info

CHICAGO (AP) — Want to know how much a hip replacement will cost? Many hospitals won’t be able to tell you, at least not right away — if at all. And if you shop around and find centers that can quote a price, the amounts could vary astronomically, a study found.

Routine hip replacement surgery on a healthy patient without insurance may cost as little as $ 11,000 — or up to nearly $ 126,000.

That’s what researchers found after calling hospitals in every state, 122 in all, asking what a healthy 62-year-old woman would have to pay to get an artificial hip. Hospitals were told the made-up patient was the caller’s grandmother, had no insurance but could afford to pay out of pocket — that’s why knowing the cost information ahead of time was so important.

About 15 percent of hospitals did not provide any price estimate, even after a researcher called back as many as five times.

The researchers were able to obtain a complete price estimate including physician fees from close to half the hospitals. But in most cases, that took contacting the hospital and doctor separately.

“Our calls to hospitals were often greeted by uncertainty and confusion,” the researchers wrote. “We were frequently transferred between departments, asked to leave messages that were rarely returned, and told that prices could not be estimated without an office visit.”

Many hospitals “are just completely unprepared” for cost questions, said Jaime Rosenthal, a Washington University student who co-authored the report.

Most hospitals aren’t intentionally hiding costs, they’re just not used to patients asking. That’s particularly true for patients with health insurance who “don’t bother to ask because they know insurance will cover it,” said co-author Dr. Peter Cram, a researcher at the University of Iowa’s medical school.

But he said that’s likely to change as employers increasingly force workers to share more health care costs by paying higher co-payments and deductibles, making patients more motivated to ask about costs.

The study was published online Monday in JAMA Internal Medicine. A California study published last year about surgery to remove an appendix found similar cost disparities.

Commenting on the study, American Hospital Association spokeswoman Marie Watteau said hospitals “have a uniform set of charges. Sharing meaningful information, however, is challenging because hospital care is unique and based on each individual patient’s needs.”

She said states and local hospital associations are the best source for pricing data, and that many states already require or encourage hospitals to report pricing information and make that data available to the public.

U.S. insurance companies typically negotiate to pay less than the billing price. Insured patients’ health plans determine what they pay, while uninsured patients may end up paying the full amount.

The study authors noted that Medicare and other large insurers frequently pay between $ 10,000 and $ 25,000 for hip replacement surgery.

Sean Toohey, a grains broker at the Chicago Board of Trade, had hip replacement surgery last summer at Loyola University Medical Center in Maywood, Ill. An old sports injury had worn out his left hip, causing “horrendous” pain on the job, where he’s on his feet all day filling orders.

Toohey, 54, said his health insurance covered most of the costs, and it didn’t occur to him to ask about price beforehand. He was back at work two weeks later and is pain free. That’s what matters most to him.

“I never really looked or paid attention” to the cost, he said.

He paid about $ 7,900, but wasn’t sure what the total bill amounted to.

The average charge for hip replacement surgery at Loyola is about $ 42,000, before the negotiated insurance rates. The most expensive items on a typical hip replacement bill include about $ 11,000 for the hip implant, said Richard Kudia, Loyola’s vice president of patient financial services

Kudia said some patients do ask in advance about costs of surgery and other medical procedures, and those questions require “a little bit of research” to come up with an average estimate. Costs vary from center to center because “there is no standard pricing among hospitals across the country. Each hospital develops its own pricing depending on its market,” he said.

An editorial accompanying the hip replacement study said “there is no justification” for the huge cost variation the researchers found.

A few online sites provide price comparisons for common medical procedures, but the editorial said that kind of information “is of almost no value” without information on hospital quality.

A proposed federal measure that would have required states to force hospitals to make their charges public failed to advance in Congress last year but could be revived this year, the editorial says.

“It is time we stopped forcing people to buy health care services blindfolded,” the editorial said.

___

Online:

Journal: http://www.jamainternalmed.com

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FDA rebuff deals big blow to Novo Nordisk’s U.S. hopes

COPENHAGEN (Reuters) – U.S. regulators dealt a major blow to Novo Nordisk‘s hopes for its new long-acting insulin Tresiba by demanding the Danish drugmaker conduct additional clinical tests to assess potential heart risks.

Novo, the world’s biggest insulin maker, said the U.S. Food and Drug Administration (FDA) had requested additional data from a dedicated cardiovascular outcomes trial before it would consider approving Tresiba and related product Ryzodeg.

The drugmaker – which is banking on Tresiba to keep it in the lead in diabetes care – said on Sunday it did not expect to be able to provide the data during 2013. Analysts said the FDA’s stance could delay Tresiba until 2015 or 2016.

“They will have to make new studies and that will delay the launch of Tresiba in the U.S. by two to three years,” Sydbank analyst Soren Hansen said.

“It is a really bad situation … I expect the share will fall significantly on Monday.”

The setback for Tresiba, also known as degludec, is good news for rival makers of insulin medicines, including France’s Sanofi, whose Lantus product is under threat from Novo’s newer ultra-long-lasting treatment.

Most investors had expected a green light from the U.S. watchdog, following a positive recommendation from an advisory panel to the FDA last November.

Optimism about Tresiba and Ryzodeg – which combines degludec with another formulation of insulin – was further boosted by approval in Europe, where the drugs won a final go-ahead last month. They have also been approved in Japan.

Tresiba and Ryzodeg have been widely tipped by analysts to become multibillion-dollar-a-year sellers worldwide.

CONFOUNDS EXPECTATIONS

The FDA’s decision to issue Novo with a so-called “complete response letter” therefore confounded consensus expectations. Such letters are issued when the U.S. agency determines that an application cannot be approved in its existing form.

“We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review,” Novo Chief Executive Lars Rebien Sorensen said in a statement.

Concerns about the cardiovascular safety of Tresiba are not new, but Novo and most analysts had thought the issue had been resolved.

The FDA advisers meeting last year expressed concern about a trend toward higher incidence of adverse heart events with the new insulin than with older ones. However, the differences seen in 16 large clinical trials were not statistically significant.

In addition to calling for new trials on Tresiba’s heart safety, the FDA said approval for Tresiba and Ryzodeg could not be granted until violations cited in a December 12 warning letter had been resolved.

Novo said the FDA’s decision not to grant approval at the present time was not expected to impact significantly its financial forecasts for the current year.

The big concern of investors, though, is that a lengthy delay in getting Tresiba launched in the world’s biggest drugs market will seriously undermine Novo’s ability to stay ahead of rivals such as Sanofi and Eli Lilly.

(Additional reporting by Ole Mikkelsen and Ben Hirschler; Editing by Maureen Bavdek and Dale Hudson)

Health News Headlines – Yahoo! News

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