Tunisia to auction Ben Ali’s treasures

Tunisia to auction Ben Ali’s treasures

Dec 20

Published: Dec. 20, 2012 at 11:44 AM

TUNIS, Tunisia, Dec. 20 (UPI) – The Tunisian government said it will auction off art and cars Sunday that once belonged to the family of ousted dictator Zine el-Abidine Ben Ali.

Tunisia representatives said they hope to raise more than $13 million from the auction.

Middle East Online said the highlight of the auction is the former president’s cars, which include a Lamborghini Gallardo LP 460.

Middle East Online said 300 jewelry items, carpets, tables, televisions and computers will be put up for sale at a hotel in Gammarth, a suburb of Tunis.

Acting Finance Minister Slim Besbes said the items belonged to Ben Ali and 114 of his relatives.

“Except [citizens] of Israel, the sale is open to everyone,” Besbes said.

Besbes said the auction will be held under tight security and $20 will be charged for entry.

Middle East Online said Ben Ali now lives in exile in Saudi Arabia with his wife after fleeing during the uprisings last year.

Josie Bissett Holly Combs

A New Antidepressant Inspired by Ketamine

A New Antidepressant Inspired by Ketamine

Dec 20

A promising treatment for clinical depression that works like a club drug has passed its first round of testing.

RTR1R9U5615.png

Paul Yeung/Reuters

The latest “breakthrough” in depression treatment is a drug that’s supposedly able to relieve symptoms in a little over an hour. It works in patients who were previously resistant to treatment that, in any case, could take weeks to start working. 

Related Story

‘The Biggest Breakthrough in Depression Research’ in 50 Years Is … Ketamine?

The strongest effects of the new drug, which is being tested by the National Institutes of Health, only lasted for about a half-hour, sometimes lingering for two more days. But the researchers are encouraged because so far, the drug seems to be just as promising as ketamine.

Yep, that ketamine. The club drug, as a positive side effect of its other, dissociative side effects, is able to rapidly relieve symptoms of depression in the most hopeless of cases. The news from this past October was that its ability to do so was helping scientists to rethink the way they conceptualize the depressed brain. As I reported then, the focus was shifting away from the “low levels of serotonin” model of depression:

Instead, the studies reviewed here support a different theory, one which suggests that depression is the result of damage to the brain cells responsible for controlling mood. In mice, at least, this atrophy of neurons occurred in response to stress. Although the reasons stress causes this to happen are unclear, the weakening of synaptic connections appears to be at the root of depression and other stress-related disorders.

SSRIs are intended to increase brain levels of serotonin, but they do also, eventually, restore neurons. Ketamine is able to repair these synaptic connections in mice with near-miraculous speed. Indirect evidence from brain imaging supports the theory that this “synaptogensis” is the mechanism allowing for ketamine’s rapid effects in humans as well.

Reporting on these findings, Yale researchers writing in Science expressed the hope that they’d be able to develop faster-acting, longer-lasting antidepressants that work through the same mechanism, but that they’d feel more comfortable prescribing than a drug that variably causes “pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium.” The promise this holds for people with depression, especially those for whom SSRIs and electroconvulsive therapy have proven ineffective, can’t be overstated.

The results from the NIH’s clinical trial are a first step in this direction. The new drug isn’t as headline-grabbing as ketamine — it’s definitely going to need a better name than its current “AZD6765″ — but when tested on 22 patients, it had a 32 percent success rate, which is approaching the 52 percent seen with ketamine. Strengthening its case, AZD6765 worked significantly better than a placebo, and had fewer ketamine-like side effects.

The trial established “proof of concept,” meaning that although there’s still much more testing and refinement to do before it can begin to be offered to the wider public, researchers are at least heading in the right direction.

This article available online at:

http://www.theatlantic.com/health/archive/2012/12/a-new-antidepressant-inspired-by-ketamine/266427/

Lara Bingle Sophia Bush

Don’t Miss Ulta’s Biggest Cyber Monday Ever!

Don’t Miss Ulta’s Biggest Cyber Monday Ever!

Dec 20
$10 off $50 Ulta.com purchase! Use coupon code 85277, exclusions apply.

$20 off $100 Ulta.com purchase! Use coupon code 82293, exclusions apply.

Carrie Fisher Joan Jett

A New Antidepressant Inspired by Ketamine

A New Antidepressant Inspired by Ketamine

Dec 20

A promising treatment for clinical depression that works like a club drug has passed its first round of testing.

RTR1R9U5615.png

Paul Yeung/Reuters

The latest “breakthrough” in depression treatment is a drug that’s supposedly able to relieve symptoms in a little over an hour. It works in patients who were previously resistant to treatment that, in any case, could take weeks to start working. 

Related Story

‘The Biggest Breakthrough in Depression Research’ in 50 Years Is … Ketamine?

The strongest effects of the new drug, which is being tested by the National Institutes of Health, only lasted for about a half-hour, sometimes lingering for two more days. But the researchers are encouraged because so far, the drug seems to be just as promising as ketamine.

Yep, that ketamine. The club drug, as a positive side effect of its other, dissociative side effects, is able to rapidly relieve symptoms of depression in the most hopeless of cases. The news from this past October was that its ability to do so was helping scientists to rethink the way they conceptualize the depressed brain. As I reported then, the focus was shifting away from the “low levels of serotonin” model of depression:

Instead, the studies reviewed here support a different theory, one which suggests that depression is the result of damage to the brain cells responsible for controlling mood. In mice, at least, this atrophy of neurons occurred in response to stress. Although the reasons stress causes this to happen are unclear, the weakening of synaptic connections appears to be at the root of depression and other stress-related disorders.

SSRIs are intended to increase brain levels of serotonin, but they do also, eventually, restore neurons. Ketamine is able to repair these synaptic connections in mice with near-miraculous speed. Indirect evidence from brain imaging supports the theory that this “synaptogensis” is the mechanism allowing for ketamine’s rapid effects in humans as well.

Reporting on these findings, Yale researchers writing in Science expressed the hope that they’d be able to develop faster-acting, longer-lasting antidepressants that work through the same mechanism, but that they’d feel more comfortable prescribing than a drug that variably causes “pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium.” The promise this holds for people with depression, especially those for whom SSRIs and electroconvulsive therapy have proven ineffective, can’t be overstated.

The results from the NIH’s clinical trial are a first step in this direction. The new drug isn’t as headline-grabbing as ketamine — it’s definitely going to need a better name than its current “AZD6765″ — but when tested on 22 patients, it had a 32 percent success rate, which is approaching the 52 percent seen with ketamine. Strengthening its case, AZD6765 worked significantly better than a placebo, and had fewer ketamine-like side effects.

The trial established “proof of concept,” meaning that although there’s still much more testing and refinement to do before it can begin to be offered to the wider public, researchers are at least heading in the right direction.

This article available online at:

http://www.theatlantic.com/health/archive/2012/12/a-new-antidepressant-inspired-by-ketamine/266427/

Catherine Bosley Nigel Hawthorne

Sudan, South Sudan broker fragile truce

Sudan, South Sudan broker fragile truce

Dec 19

Published: Dec. 19, 2012 at 12:59 PM

ADDIS ABABA, Ethiopia, Dec. 19 (UPI) – South African negotiator Thabo Mbeki said Sudanese leaders have agreed to take immediate steps on border security, though implementation is unclear.

Sudanese and South Sudanese leaders met in Ethiopia this week to discuss hostilities between both sides. South Sudan last year became an independent country under the terms of a peace deal that ended the Sudanese civil war. Oil disputes, ethnic fighting and border insecurity have remained problematic, however.

Mbeki, former South African president and peace negotiator for the African Union, said both sides have agreed on a demilitarized zone along their shared border.

“Now in the agreement, it says within seven days, but in reality it’s going to take longer,” he was quoted by Voice of America as saying.

The independent Sudan Tribune, meanwhile, reports that it’s unclear whether both sides were able to negotiate the disarming of South Sudan’s rebel Sudan People’s Liberation Movement-North.

SPLM-N Secretary-General Yasir Arman was quoted by the Sudanese newspaper as saying, however, the group has “expressed its readiness and unwavering commitment for an immediate humanitarian cessation of hostilities.”

Conflicts over the disputed border region of oil-rich Heglig this year nearly pushed both sides to war.

Alex Kingston Helena Christensen

1,458 Bacteria Species ‘New to Science’ Found in Our Belly Buttons

1,458 Bacteria Species ‘New to Science’ Found in Our Belly Buttons

Dec 19

But most bacteria are, like people, “either good or simply present.”

dirty navels 615.jpg

[torbackhopper/flickr]

Instead of taking your fingerprint, maybe police should swab our belly buttons with Q-tips. No, that’s ridiculous, actually. But the idea illustrates a point made by a group of North Carolina-based researchers in their new Belly Button Biodiversity (BBB) project. Last month, the group published results of their first of many experiments, in which they swabbed 60 belly buttons and identified a total of 2,368 species of bacteria. People’s individual profiles were snowflake-ily, bacterially unique. 

As the BBB understands it, like exploring the depths of our majestic oceans, there’s much to be learned from our belly button hangers-on. National Geographic reported that 1,458 of the species “may be new to science,” and some of the bacteria were entirely out of their known context. One person’s belly button “harbored a bacterium that had previously been found only in soil from Japan,” where he had never been. Another had two types of “extremophile bacteria that typically thrive in ice caps and thermal vents.” 

SHARK300200.jpgAnonymous samples from a belly button sampling event. Which one are you? F/M/K?

“The belly button has captured the imagination for centuries,” BBB notes on their impeccably-URL-ed site, WildLifeOfYourBody.org. Prior to those centuries, belly buttons captured no one’s imagination. To be fair, in those days, imaginations were much less amenable to capture. They wandered, wily and free, with a discerning taste, the likes of which our indolent, Internet-weary imaginations of today know nothing.

When you return from this journey into the belly button of your mind, you can participate in one of the BBB’s very real “sampling events,” where you volunteer to be navally swabbed with a Q-tip. They then assign you an anonymous number, and in a few days you can then go online and look photos of what grows — your belly button bacterial profile — and learn about the little beings with whom you share your body.

If you’re just starting to date someone, or more seriously vetting them as a marriage candidate, you might suggest going to one of these sampling sessions as a fun date. But then, like so many dates, it’s actually a test to see how dirty they are. It’s anonymous, yes, but if you stand next to each other in line, you’ll know what their number is, and you can look it up later.

It’s up to you how you interpret the results. Dirtier is not necessarily worse, and that’s one important point BBB wants their work to make. The vast majority of bacteria in the world live in harmony with us, and don’t want to kill us. No, they want us to live and thrive, so we can keep being their warm homes. So they may actually be helping us.

As the BBB puts it, most bacteria are, like people, “either good or simply present.”

So should you be making extra effort to clean out the many bacteria in your belly button? I say no. Unless it’s visibly grimy, or you have a history of belly button infections, or just reading about this research no longer allows you to live comfortably with the knowledge that you are an infestation. Others will disagree — like Dr. Claire Cronin of the Massachusetts Medical Society. She notes that in the era of laparoscopic surgery, where the belly button is commonly used as a port of surgical access, there is virtue in keeping tidy down there:

There is a surprising lack of awareness on the public’s part as to what can accumulate in a belly button … the volume of material increases as the patient ages and, just like their arteries, can harden. I like to think of it as a cache of a lifetime of little treasures. … Most patients have not received adequate instruction on proper umbilical hygiene. It has not received the same level of attention that the area behind the ears has. … There is a technique to cleaning the belly button. It involves soap and water and gentle probing. … Alcohol should not be used, in order to not disturb the delicate pH balance of the area.

Beyond worrying about the embarrassment of doctors discovering “blackened wax casts,” in your belly button, though, the BBB project could make important progress in understanding how the bacteria that colonize us actually affect our health. Analogous to the parasite Toxoplasmosis gondii – which we only recently found out is present in 20-50 percent of our brains, subtly shaping our personalities and maybe even making us try to hurt ourselves — some of these little bacteria that go unnoticed are probably affecting us in ways unknown, good and bad. Ways that we’re currently just chalking up to chance or genetics or God or gluten. 

Meanwhile, BBB is now in the pilot phase of testing armpits, which is less fascinating, but doesn’t lose sight of their thesis that “in all likelihood your body hosts species that no scientist has ever studied.” That’s not meant to be used as a pick-up line.


[via Lansing State Journal and Becca Rosen]

Thora Birch Veronika Zemanova

Amgen to pay $762 million, pleads guilty in marketing case

Amgen to pay $762 million, pleads guilty in marketing case

Dec 19

NEW YORK | Tue Dec 18, 2012 1:25pm EST

(Reuters) – Amgen Inc pleaded guilty in a New York federal court on Tuesday for improper marketing practices involving its once top-selling Aranesp anemia drug, and prosecutors said the company has agreed to pay $762 million in a civil settlement and criminal fines.

The world’s largest biotechnology company had set aside funds it expected to have to pay as a result of federal and state investigations, as well as nearly a dozen civil whistleblower lawsuits.

Federal prosecutors said in court that the company had agreed to pay $612 million in a civil settlement, a $14 million criminal forfeiture payment, and a $136 million criminal fine.

Amgen entered the guilty plea to one misdemeanor count. Acting U.S. attorney Marshall Miller confirmed that under the agreement Amgen will not lose any federal business or contracts. Exclusion from federal programs, such as Medicare, could have crippled its business.

As part of the deal, Amgen will enter into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services, prosecutors said. The agreement will require Amgen’s executives and members of its board of directors to certify compliance with applicable regulations, institute new transparency measures and put corporate officers “on the hook” for compliance failures within that five-year period, prosecutors said.

The plea agreement must be approved by U.S. District Judge Sterling Johnson. He has scheduled a hearing for Wednesday morning.

Aranesp, primarily used to treat anemia in cancer patients undergoing chemotherapy, remains one of Amgen’s largest drugs with sales of $2.3 billion in 2011. Its sales, and that of a related older red blood cell booster Epogen, have declined significantly over the past few years amid safety concerns, stricter usage guidelines and reimbursement restrictions.

Amgen was accused of promoting Aranesp for anemia caused by cancer, for which it was not approved, rather than to combat anemia as a side effect of chemotherapy treatments. The company was also accused of pushing higher doses and more convenient treatment schedules than what was approved in the drug’s label for both cancer and chronic kidney disease patients.

The government said the illegal practices were undertaken in part to help Amgen take market share from Johnson & Johnson’s similar anemia drug Procrit.

Amgen was “pursuing profits at the risk of patients’ safety,” Miller told reporters Tuesday after the plea hearing. He added that while the company “circumvented the FDA approval process,” the investigation had not uncovered any evidence of fraudulent intent on Amgen’s part.

Federal prosecutors declined to comment further on the civil portion of the settlement, which they said is still under seal.

A spokeswoman for the company, based in Thousand Oaks, California, said that if the judge accepts the criminal plea tomorrow, “Amgen expects immediately thereafter to complete the comprehensive resolution of related civil and criminal matters,” for which it had previously recorded a $780 million charge in the third quarter of 2011.

In a recent regulatory filing with the U.S. Securities and Exchange Commission, Amgen said it had accrued $806 million related to the proposed settlement of charges arising out of the federal civil and criminal investigations.

Amgen shares were down 14 cents at $89.36 in late morning trading on the New York Stock Exchange.

(Additional reporting and writing by Bill Berkrot and Caroline Humer; Editing by Lisa Von Ahn, Andrew Hay and David Gregorio)

Jeri Ryan Carla Bonner

Diabetes remission possible with diet, exercise

Diabetes remission possible with diet, exercise

Dec 19

NEW YORK | Tue Dec 18, 2012 4:45pm EST

(Reuters Health) – One in nine people with diabetes saw their blood sugar levels dip back to a normal or “pre-diabetes” level after a year on an intensive diet and exercise program, in a new study.

Complete remission of type 2 diabetes is still very rare, researchers said. But they added that the new study can give people with the disease hope that through lifestyle changes, they could end up getting off medication and likely lowering their risk of diabetes-related complications.

“Kind of a long-term assumption really is that once you have diabetes there’s no turning back on it, and there’s no remission or cure,” said Edward Gregg, the lead author on the report from the Centers for Disease Control and Prevention.

The research, he told Reuters Health, “is a reminder that adopting a healthy diet, physically-active lifestyle and reducing and maintaining a healthy weight is going to help manage people’s diabetes better.”

His team’s study can’t prove the experimental program – which included weekly group and individual counseling for six months, followed by less frequent visits – was directly responsible for blood sugar improvements.

The original goal of the research was to look at whether that intervention lowered participants’ risk of heart disease (so far, it hasn’t).

But the diabetes improvements are in line with better weight loss and fitness among people in the program versus those in a comparison group who only went to a few annual counseling sessions, Gregg’s team reported Tuesday in the Journal of the American Medical Association.

IS IT COST-EFFECTIVE?

About eight percent of people in the United States have diabetes, according to the American Diabetes Association. The new study included 4,503 of them who were also overweight or obese.

People randomly assigned to the intensive program had diet and exercise counseling with a goal of cutting eating and drinking back to 1200 to 1800 calories per day and increasing physical activity to just under three hours per week.

After one year, 11.5 percent of them had at least partial diabetes remission, meaning that without medication their blood sugar levels were no longer above the diabetes threshold. That compared to just two percent of participants in the non-intervention group who saw their diabetes improve significantly.

People who’d had diabetes for fewer years were more likely to have blood sugar improvements, as were those who lost more weight or had stronger fitness gains during the study.

However, less than one-third of people whose diabetes went into remission during the program managed to keep their blood sugar levels down for at least four years, the researchers found.

“Clearly lifestyle intervention is good for people with diabetes,” said Dr. John Buse, a diabetes researcher from the University of North Carolina at Chapel Hill School of Medicine.

“The question is how cost-effective is it, what are the long-term consequences (and) how would it really compare with alternative approaches like bariatric surgery and drug therapy?” Buse, who wasn’t involved in the new study, told Reuters Health.

Dr. David Arterburn, from Group Health Research Institute in Seattle, said some studies of weight-loss surgery, for instance, have found two-thirds of people who start out with diabetes have complete remission.

Arterburn, who co-wrote an editorial published with the new study, said anyone with diabetes – or at high risk – should consider either lifestyle interventions or surgery, if they’re eligible, to reduce future health risks.

Gregg said his team was working on a cost-analysis of the current program, but that it was fairly “resource-intensive.”

“If people have access to the support to make these sorts of changes, they may have the benefits that we’ve seen here,” he said. But, “What we should remember is that more modest changes in lifestyle are also effective.”

SOURCE: bit.ly/JjFzqx Journal of the American Medical Association, online December 18, 2012.

Susan George Melanie Griffith

Bessie Cameron John Roland Couple celebrate 70 years of marriage after she fainted in to the arms of a stranger as the first bombs of World War II began to fall

Bessie Cameron John Roland Couple celebrate 70 years of marriage after she fainted in to the arms of a stranger as the first bombs of World War II began to fall

Dec 19

By Deni Kirkova

|

Bessie Cameron literally ‘fell’ for her husband of seventy years – she fainted into his arms when the first bombs fell in 1940 – and they are now celebrating their 70th wedding anniversary.

She says the spark between them hasn’t changed from that moment outside the Coliseum cinema in Barrow, Cumbria.

She and John Roland ‘Roly’ Fry wed two years later.

She said: ‘It was the day after the first bomb on Prospect Road, where I worked. I was still shaken about it.’

Bessie Cameron 'fell' for her a stranger - she fainted into his arms when the first bombs fell in 1940 - and they're now celebrating their 70th wedding anniversary

Bessie Cameron ‘fell’ for her a stranger – she fainted into his arms when the first bombs fell in 1940 – and they’re now celebrating their 70th wedding anniversary

Outside the cinema in a doorway Mrs Fry fainted.

When she became conscious again she found Mr Fry had come to her rescue. Mrs Fry, 92, said: ‘We are still in love today definitely.’

Mr Fry joked: ‘She fell for me right away.’

Mrs Fry said: ‘It was love at first sight. As soon as I saw him I liked him.’

The couple, who still live in Barrow, married shortly after they met and had two sons together.

They say they’re just as in love as the moment they met.

'We were together about 18 months before we got married'

‘We were together about 18 months before we got married’

Mrs Fry said: ‘We were together about 18 months before we got married.’

They were wed in the Barrow register office on December 19, 1942. Mrs Fry, who was 22 when they married, said on the wedding day she wore a ‘little coat and a dress’.

However, as it was during the war, she didn’t have a ‘fancy’ dress.

After they were married, Mr Fry went to college to learn to cook for Mrs Fry. Tomorrow, Mr Fry, 90, will be cooking his wife her favourite meal, chicken with all the trimmings, and they will spend some quality time with just the two of them together.

The couple met when Bessie fainted into John’s arms when the first bombs fell in 1940 outside the Coliseum cinema on Prospect Road in Barrow, Cumbria

Mrs Fry said she was looking forward to the big day, although the pair won’t be throwing a party. She said: ‘We just want to be together.’

The pair have spent many happy times together in their 70 years of marriage. Mrs Fry said: ‘He has made me very happy.’

She said among her favourite memories of their time together are the times they went on holiday.

She said: ‘We used to go camping in the Lake District. We have had some lovely holidays.’

Now celebrating their 70th wedding anniversary, the spark between them 'hasn't changed'

Now celebrating their 70th wedding anniversary, the spark between them ‘hasn’t changed’

Mrs Fry said she was looking forward to the big day. She said: 'We just want to be together'

Mrs Fry said she was looking forward to the big day. She said: ‘We just want to be together’

Jessica Drake Alex Kingston

Don’t Miss Ulta’s Biggest Cyber Monday Ever!

Don’t Miss Ulta’s Biggest Cyber Monday Ever!

Dec 18
$10 off $50 Ulta.com purchase! Use coupon code 85277, exclusions apply.

$20 off $100 Ulta.com purchase! Use coupon code 82293, exclusions apply.

Ashley Greene Holly Sampson

GlaxoSmithKline wins U.S. approval for new flu vaccine

GlaxoSmithKline wins U.S. approval for new flu vaccine

Dec 18
Signage is pictured on the company headquarters of GlaxoSmithKline in west London July 21, 2008. REUTERS/Toby Melville

Signage is pictured on the company headquarters of GlaxoSmithKline in west London July 21, 2008.

Credit: Reuters/Toby Melville

Mon Dec 17, 2012 12:03pm EST

(Reuters) – U.S. health regulators have approved a new four-strain seasonal influenza vaccine made by GlaxoSmithKline Plc, the company said on Monday.

The U.S. Food and Drug Administration has approved Fluarix Quadrivalent to immunize children age 3 and older and adults against flu virus subtypes A and B contained in the vaccine.

It is the first intramuscular vaccine to protect against four influenza strains. Three-strain flu vaccines currently administered help protect against the two most common A virus strains and the B strain expected to be predominant in a given year, the company said.

Since 2000, however, two B virus strains have circulated to varying degrees each season, meaning patients infected with the B virus not contained in the vaccine were not immunized.

Fluarix Quadrivalent helps protect against the two A strains and adds coverage against a second B strain, the company said.

Three-strain vaccines “have helped protect millions of people against flu, but in six of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected,” said Dr. Leonard Friedland, head of clinical development and medical affairs for Glaxo’s North American vaccines program.

“Fluarix Quadrivalent will help protect individuals against both B strains and from a public-health standpoint, can help decrease the burden of disease.”

Glaxo said it will make the vaccine available in time for the 2013-14 flu season and plans to fulfill orders for its trivalent, or three-strain, vaccines. Healthcare providers traditionally order flu vaccines about a year in advance of each flu season.

Fluarix Quadrivalent is not currently approved or licensed in any country outside of the United States.

(Reporting By Toni Clarke; Editing by Maureen Bavdek)

Veronika Zemanova Barbara Schoeneberger

Why Annual Pelvic Exams Might Be Bad

Why Annual Pelvic Exams Might Be Bad

Dec 18

In the era of constantly rethinking screening exams, researchers are exploring the time-honored bimanual exam.

7372133654_b6f3d12674_z615.jpg

Baalel/Flickr

A study published in the American Journal of Obstetrics & Gynecology is questioning the perceived wisdom of the annual pelvic exam, not just as an important means of screening for ovarian cancer (which, according to the authors, it isn’t) but as being necessary at all.

The researchers, from UCSF, are referring not to the visual examination of external genitalia or to the use of the speculum, but specifically to the part of the exam where the physician inserts two fingers into the vagina to feel the ovaries, cervix, and uterus. While annual Pap smears to test for cervical cancer are no longer officially recommended for most women, the possible case against pelvic exams has remained less clear. The American Congress of Obstetricians and Gynecologists this August changed its recommendations for the pelvic exam, restricting it to women 21 and over, but its reasoning for even this was far from sound:

An annual pelvic examination seems logical, but also lacks data to support a specific time frame or frequency of such examinations. The decision whether or not to perform a complete pelvic examination at the time of the periodic health examination for the asymptomatic patient should be a shared decision after a discussion between the patient and her health care provider.

Pelvic exams are still recommended as a means of screening for ovarian cancer: the Mayo Clinic, WebMD, and the New York Times all list it as a first-step measure in preventing the disease. Half of the over 500 physicians surveyed for this study thought it was very important for this purpose, and nearly all endorsed conducting the exam on low-risk women. Beyond that, they were also all for performing the exam on a hypothetical 55-year-old woman whose ovaries, uterus, and cervix had been removed.


MORE ON WOMEN’S HEALTH

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If the authors are right, this could come down to the insidious nature of common “knowledge” — women go in for the exam because they’ve been lead to believe it’s necessary, and doctors perform it, according to the study, because women expect them to. Indeed, the physicians indicated things like “it reassures the patients of their health” and “it ensures adequate compensation for routine gynecologic care” as rationale. The problem is, if it’s not actually “medically necessary,” we might, at best, be wasting time and money, suffering uncomfortable exams for the sake of trite reassurance. At worst, we’re causing need for costly and unnecessary follow-ups or being falsely reassured.

If the exam turns out to provide some degree of good, there’s no reason not to be all for it. But if we’re all just doing it for no other reason than “it seems logical” and we think we’re supposed to, it’s past time to abandon it.

This article available online at:

http://www.theatlantic.com/health/archive/2012/12/why-annual-pelvic-exams-might-be-bad/266359/

Rebecca Gibney Lillian Muller

Many have ovary surgery even with negative gene test

Many have ovary surgery even with negative gene test

Dec 18

NEW YORK | Mon Dec 17, 2012 4:36pm EST

(Reuters Health) – Many women who test negative for gene mutations that heighten the risk of ovarian cancer still get their ovaries removed despite a lack of evidence that it reduces the risk of dying, says a new study.

“A higher number than expected went through with the surgery, and it probably has to do with doctors in the community not having enough information on their patients’ risk levels,” said Dr. Gabriel Mannis, the study’s lead author.

According to Mannis and his colleagues, who published their study in the Archives of Internal Medicine on Monday, the average woman’s risk of developing ovarian cancer is about 2 percent, but women with BRCA1 and BRCA2 gene mutations have a 40 percent and 20 percent risk, respectively.

For women that test positive for the gene mutations, the American Congress of Obstetricians and Gynecologists (ACOG) says, if they choose to have their ovaries removed, it should be when they are done having children and near 40 years old.

There are no guidelines, however, on ovary removal and screening for women whose blood tests don’t show the gene mutations but who may still be at an increased risk of cancer based on their family’s medical history.

“We don’t have a clear sense of what their risk level is, or what the role of screening should be,” said Mannis, of the division of oncology at the University of California, San Francisco.

For the new study, the researchers surveyed women at two hospitals about 4 years after they were tested for the gene mutations to see if they decided to be screened or have their ovaries removed.

Of 1,077 women surveyed, about 19 percent tested positive for a BRCA mutation, about 10 percent had no mutation, and the rest had unclear results.

The researchers found that about 70 percent of the women who tested positive for a mutation had their ovaries removed by the time they took the survey.

But, despite a lack of evidence that they should have their ovaries removed, about 12 percent of the women with unclear results still had the surgery.

OVARIAN CANCER SCREENING

The researchers also found that despite the U.S. Preventive Services Task Force recommending against screening for ovarian cancer in women without the gene mutations, about 20 percent of women whose test results didn’t clearly show the mutations still ended up getting screened in the year before taking the survey.

In a previously published study, women screened annually for ovarian cancer were no less likely to die from the disease than those who didn’t get regular screening (see Reuters Health article of Sep. 10, 2012. reut.rs/QAmMdk).

Aside from not being shown to help, the tests are also imperfect, said Dr. Jed Delmore, chair the Gynecologic Oncology Sub-committee for ACOG.

“I can simply say that as of today we don’t have a good screening,” said Delmore, of the University of Kansas School of Medicine in Wichita.

“At this point if doctors are going to proceed with screening in this group of women, there needs to be a conversation that we don’t really know if this will prevent you from dying sooner of ovarian cancer or that it may come back as a false positive,” said Mannis.

In that previous study, about one in ten screened women had a false positive result, and of those a third had one or both ovaries removed.

That means some women had both ovaries removed even though they were not at an increased risk for cancer, which needlessly put them in danger of a complication and forced them into menopause.

Plus, the removing an ovary can cost over $3,000.

Delmore told Reuters Health that it seems like an intermediate ground has been reached with a majority of BRCA-positive women having surgery to reduce their risk, and fewer BRCA-negative women having it.

He agreed with Mannis that doctors need to be honest with their patients about the limitations of today’s screenings and treatments.

“We have pretty solid information for women who are BRCA positive and clearly BRCA negative,” he said. “It’s just that group in the middle.”

Mannis told Reuters Health that the next step would be to identify that group’s risk levels, but both he and Delmore said that won’t be easy.

SOURCE: bit.ly/WiwDtv Archives of Internal Medicine, online December 17, 2012.

Rebecca Romijn Olivia Thirlby

Recreational marijuana should not be top federal priority: Obama

Recreational marijuana should not be top federal priority: Obama

Dec 18

WASHINGTON (Reuters) – President Barack Obama says federal authorities should not target recreational marijuana use in two Western states where it has been made legal given limited government resources and growing public acceptance of the controlled substance.

His first comments on the issue come weeks after Washington state and Colorado voters supported legalizing pot, or cannabis, last month in ballot measures that stand in direct opposition of federal law.

“It does not make sense from a prioritization point of view for us to focus on recreational drug users in a state that has already said that under state law that’s legal,” he told ABC News in part of an interview released on Friday.

“At this point (in) Washington and Colorado, you’ve seen the voters speak on this issue. And, as it is, the federal government has a lot to do when it comes to criminal prosecutions,” Obama said.

The Department of Justice has said pot remains a federally controlled substance and states have been looking for guidance from Washington on how it will handle the conflict with state laws.

Medical use of the substance is legal in 18 U.S. states. But federal officials have still continued to crack down on some providers in those states.

Pot remains an illegal narcotic under U.S. law, but Washington and Colorado became the first states in the nation to legalize recreational marijuana use on November 6. A similar effort in Oregon failed.

Obama called the situation “a tough problem, because Congress has not yet changed the law.” He told ABC that “what we’re going to need to have is a conversation about” how to reconcile federal and state laws, and that he has asked U.S. Attorney General Eric Holder to examine the issue.

In his 1995 memoir, “Dreams of My Father,” Obama admitted to regularly smoking pot in high school. The father of two told ABC that he would not go so far as to say pot should be legalized altogether. There are also concerns about drug use in children and violence, he told ABC, according to its website.

“I want to discourage drug use,” he added.

The new measures in Washington and Colorado, which already permit medical marijuana use, allow possession of up to an ounce of the substance for private use. They also will regulate and tax sales at special stores for those aged 21 and older.

Nancy Allen Sophie Lee

Inherited colon cancer risk tied to certain foods

Inherited colon cancer risk tied to certain foods

Dec 18

NEW YORK | Mon Dec 17, 2012 2:16pm EST

(Reuters Health) – Among people who have a genetic susceptibility to colon cancer, those whose diets are heavy in junk food have an even higher risk, according to a new study.

“These patients have this very high risk because of this (genetic) mutation they have, but it might be that they could reduce the number of (tumors) by having a more healthy lifestyle,” said Akke Botma, the lead author of the study.

Botma’s study is just the first to find a link between certain foods and a higher colon cancer risk in this group, and it can’t prove that the diet is to blame.

All of the people in the study had Lynch syndrome, a genetic disorder that predisposes people to cancer at younger ages and that affects up to one in 660 people.

In Western countries, colorectal and endometrial cancers are the dominant cancers to turn up in people with the syndrome, while in Asia it’s mostly stomach cancer, Botma said.

Up to 70 percent of people with Lynch syndrome will develop colon cancer. Among people without Lynch syndrome, such cancers are thought to be influenced by diet, particularly alcohol and red and processed meat, the authors note in their study, published in the journal Cancer.

Botma and her colleagues at Wageningen University in the Netherlands contacted 486 people with Lynch syndrome from a national database of families with inherited risks for cancer.

At the beginning of the study they surveyed the participants about what they ate, and they ranked each person on whether he ate low, medium or high amounts of foods within four dietary categories.

The food groups included one that was dominated by fruits, vegetables and whole grains; another that was high in meat and coffee; a third dietary group that resembled a Mediterranean diet – fish, leafy greens, pasta, sauces and wine; and a fourth group that was heavy on fried snacks, fast food and diet soda.

Botma and her colleagues found that, over 20 months of follow up, 56 of the participants — or 12 percent — screened positive for tumors in the colon, a precursor to cancer.

Of the four dietary groupings, only the junk food category showed any link with a different risk for developing colon tumors.

Of the 160 people who scored low on the junk food diet, 17 developed tumors, while 18 out of the 160 people who ate the most junk food developed tumors.

The numbers initially seemed similar, but after taking into account smoking and other risk factors, the researchers determined that those in the high junk food group were twice as likely to develop colon tumors.

HOW TO MANAGE RISKS?

“It’s hard to say why” junk food is linked with a greater risk for these tumors, said Dr. Mala Pande, an instructor at the University of Texas MD Anderson Cancer Center in Houston who was not involved in the research.

She said some researchers have suggested that high fat might have something to do with it, but it’s impossible to conclude that from this study.

Although the findings are too preliminary to be used in making dietary recommendations to people with Lynch Syndrome, the study was valuable in launching research into the possible role of certain foods on cancer risk, said Christopher Amos, a professor at the Geisel School of Medicine at Dartmouth College.

“People with Lynch Syndrome are at higher risk, and we’d really like to know how to manage their risks better,” Amos, who was not part of the study, told Reuters Health.

Certain foods have been shown to be linked with different types of cancer, but many of those studies contradict each other and sow confusion (see Reuters Health report of December 5, 2012 here: reut.rs/YPuDcs).

Amos said the new study is a good start, but “it would be nice to confirm (it) with additional findings.”

SOURCE: bit.ly/SG85JD Cancer, online December 17, 2012.

Donna Gubbay Ashley Greene

Recreational marijuana should not be top federal priority: Obama

Recreational marijuana should not be top federal priority: Obama

Dec 17

WASHINGTON (Reuters) – President Barack Obama says federal authorities should not target recreational marijuana use in two Western states where it has been made legal given limited government resources and growing public acceptance of the controlled substance.

His first comments on the issue come weeks after Washington state and Colorado voters supported legalizing pot, or cannabis, last month in ballot measures that stand in direct opposition of federal law.

“It does not make sense from a prioritization point of view for us to focus on recreational drug users in a state that has already said that under state law that’s legal,” he told ABC News in part of an interview released on Friday.

“At this point (in) Washington and Colorado, you’ve seen the voters speak on this issue. And, as it is, the federal government has a lot to do when it comes to criminal prosecutions,” Obama said.

The Department of Justice has said pot remains a federally controlled substance and states have been looking for guidance from Washington on how it will handle the conflict with state laws.

Medical use of the substance is legal in 18 U.S. states. But federal officials have still continued to crack down on some providers in those states.

Pot remains an illegal narcotic under U.S. law, but Washington and Colorado became the first states in the nation to legalize recreational marijuana use on November 6. A similar effort in Oregon failed.

Obama called the situation “a tough problem, because Congress has not yet changed the law.” He told ABC that “what we’re going to need to have is a conversation about” how to reconcile federal and state laws, and that he has asked U.S. Attorney General Eric Holder to examine the issue.

In his 1995 memoir, “Dreams of My Father,” Obama admitted to regularly smoking pot in high school. The father of two told ABC that he would not go so far as to say pot should be legalized altogether. There are also concerns about drug use in children and violence, he told ABC, according to its website.

“I want to discourage drug use,” he added.

The new measures in Washington and Colorado, which already permit medical marijuana use, allow possession of up to an ounce of the substance for private use. They also will regulate and tax sales at special stores for those aged 21 and older.

Emily Symons Melissa Gilbert

CORRECTION: Aspirin may help older colon cancer patients live longer

CORRECTION: Aspirin may help older colon cancer patients live longer

Dec 16

[Corrects headline to sentence case in story posted Dec 7, 2012 as 20121207elin003.]

NEW YORK (Reuters Health) – Older adults with colon cancer who were prescribed a daily aspirin were less likely to die than those who weren’t, according to a new study.

While the results need to be confirmed with more rigorous studies, they add to the evidence linking aspirin use to longer survival for cancer patients. Studies have also suggested the inexpensive drug can prevent some types of the disease from occurring in the first place.

Medical guidelines currently endorse the use of low-dose aspirin to prevent heart disease, but not to fight or prevent cancer.

The new study, published in the Journal of the American Geriatrics Society, included more than 500 colon-cancer patients in the Netherlands aged 70 and older. More than 100 were prescribed daily low-dose “baby” aspirin for heart protection after their cancer diagnosis.

Between 1998 and 2007, the death rate for those prescribed aspirin was about half that of the non-aspirin users. The effect was biggest in people with more advanced cancer and in those who received no chemotherapy.

Anything that might improve survival in elderly adults with colon cancer would be welcome, since there is no consensus on whether to use chemotherapy in those patients, according to the study.

Previous studies have also associated aspirin use with increased survival. Research published in October in the New England Journal of Medicine suggested that aspirin therapy could extend survival for colon cancer patients whose tumors had a specific genetic mutation.

Still, more scientifically rigorous randomized controlled trials will be needed to confirm the findings of studies that are based on observation after the fact, and therefore less definitive about what actually causes the effect seen.

“We’re pretty sure this is a real effect, but we’re not sure of the magnitude,” said Dr. Gerrit Jan Liefers of Leiden University Medical Center in the Netherlands, an author of the new study. He said he didn’t expect randomized trials would show such a large survival advantage. Liefers is working to develop such a trial in the Netherlands.

One limitation of the study is that it looked at aspirin prescriptions, not actual use of the drug. (Low-dose aspirin for heart-disease protection isn’t available over the counter in the Netherlands.) It’s possible that heart benefits from aspirin might have helped the patients live longer, but the study authors said that alone couldn’t account for the big difference in death rates. Also, there might be differences between the groups unaccounted for by researchers that led to the improved survival among the aspirin users.

Liefers said it’s not completely clear how aspirin might combat colon cancer. One likely route: blocking the enzyme cyclooxygenase-2, or COX-2, which is involved in inflammation and is expressed in about 70 percent of colon tumors.

Boris Pasche, director of the hematology and oncology division at the University of Alabama at Birmingham, said it would be helpful to figure out who would benefit from and who could skip daily aspirin.

“It’s a fairly benign drug, but it has side effects,” including bleeding in the gastrointestinal tract and the brain, Pasche said.

He said patients should discuss with their physicians whether it makes sense to take aspirin at this point. “This supports the concept, but we need a prospective randomized trial,” he said.

SOURCE: http://bit.ly/TFEnSF Journal of the American Geriatrics Society, online November 23, 2012.

Janice Renney Jacqueline McKenzie

Fashion power couple behind Proenza Schouler label sell their two Manhattan apartments… So what will they snap up with that cool $2.8m next?

Fashion power couple behind Proenza Schouler label sell their two Manhattan apartments… So what will they snap up with that cool $2.8m next?

Dec 16

By Tamara Abraham

|

Lazaro Hernandez and Jack McCollough, better known as the design duo behind high-end label Proenza Schouler, have both listed their Manhattan apartments for sale.

According to The Real Estalker, the pair – who are the darlings of the New York fashion scene – listed the two properties with Cocoran on the same day in mid-October – though they have experienced varying degrees of success.

Mr McCollough, 33, has just sold his duplex in the West Village for $1,895,000, however Mr Hernandez, also 33 – his partner both in both business and life – has been forced to drop the price of his nearby Chelsea apartment from $985,000 to $950,000 as it lingers on the market.

Proenza Schouler

Moving on: Jack McCollough, co-founder of the Proenza Schouler label, is selling his West Village apartment for $1,895,000 – as partner Lazaro Hernandez is selling his Manhattan home

Proenza Schouler

Flooded with light: It comes as little surprise that Mr McCollough’s property sold so fast. The open-plan condo boasts huge south-facing windows in the main living space

Jack McCollough (L) and Lazaro Hernandez of New York based luxury fashion label Proenza Schouler - June 2011

Fashion darlings: Jack McCollough (left) and Lazaro Hernandez (right) are behind Proenza Schouler

It is not clear whether the pair were living together or separately, or whether they plan on buying another Manhattan property, though with a cool 2.8million between them, they could buy something very special indeed.

If they were to pool resources, it would not be their first home together – the design duo have co-owned a $1.125m late 19th-century property in the Berkshires, Western Massachusetts, since 2008.

It comes as little surprise that Mr McCollough’s property sold so fast. The open-plan condo boasts huge south-facing windows, flooding the main living space with light.

The dining area links to a small study and bathroom, with steps up to a private terrace.

The master bedroom is situated on the level below, sharing the same wide windows and bright light as the floor above.

Proenza Schouler

Luxury living: The master bedroom is situated on the level below, sharing the same wide windows and bright light as the floor above – with extensive storage befitting a fashion lover

Proenza Schouler

Reading room: The dining area links to a small study with steps up to a private terrace

It has a vast en-suite bathroom with separate shower and oversized tub, as elegantly appointed as one would expect from one of the world’s most popular fashion designers.

The listing says that the property ‘offers a great sense of privacy’, and ‘no details were spared in its renovation.’

Mr Hernandez’s apartment has a rather less fashion-forward decor, though perhaps the traditional look is appropriate for the parlour floor of an 1800s Chelsea townhouse.

Splashing out: The two bathrooms – one on the upper floor (left) and a master en-suite on the lower level (right) – are as luxuriously appointed as the rest of the apartment

Proenza Schouler

Outside space: The listing says that the property ‘offers a great sense of privacy’

Described as a ‘convertible two-bedroom’, the living room and den/second bedroom are separated by a galley kitchen finished in dark wood.

Beyond, at the back of the property, is a narrow main bedroom and large terrace.

Mr McCollough and Mr Hernandez met at Parson’s School of Design in 1999, where they were mentored by Project Runway’s Tim Gunn.

Proenza Schouler

Traditional tastes: Mr Hernandez’s apartment has a rather less fashion-forward decor, though perhaps the look is appropriate for the parlour floor of an 1800s Chelsea townhouse

Proenza Schouler

Galley style: the living room and den/second bedroom are separated by a kitchen finished in dark wood

Proenza Schouler

Floor-through: Beyond the kitchen is a den/second bedroom with doors onto a spacious terrace

Proenza Schouler

No sale: The apartment is failing to sell, so Mr Hernandez has been forced to drop the price

Before he even graduated, Mr Hernandez earned the recognition of Vogue Editor-in-Chief Anna Wintour, after passing a napkin note to her while traveling on the same plane.

This small act landed him an internship at Michael Kors, while Mr McCollough went to Marc Jacobs.

On graduating in 2002, their joint senior collection was bought in its entirety by Barneys, cementing a reputation as fashion’s brightest young stars.

High style: Looks from the Proenza Schouler fall/winter 2012 collection at New York Fashion Week in February

Ten years on, the Proenza Schouler label (named after their mothers’ maiden names) is behind countless celebrity red carpet looks, a bestselling ‘anti-It’ bag, and two coveted CFDA awards.

As The Real Estalker speculates, it is likely that the pair are trading up to a larger, even more glamorous Manhattan space, that befits their stylemaker statuses.

Thora Birch Veronika Zemanova

Daylight savings tied to bump in heart attack rates

Daylight savings tied to bump in heart attack rates

Dec 15

NEW YORK | Fri Dec 14, 2012 4:56pm EST

(Reuters Health) – Setting the clock ahead for daylight savings time may set the scene for a small increase in heart attacks the next day, according to a small new study that suggests sleep-deprivation might be to blame.

Researchers at two Michigan hospitals reviewed six years of records and found that they treated an average of 23 heart attacks on the Sunday Americans switched to daylight savings time. That compared to 13 on a typical Sunday.

“Nowadays, people are looking for how they can reduce their risk of heart disease and other ailments,” said Dr. Monica Jiddou, the study’s lead author and a cardiologist at William Beaumont Hospital in Royal Oak.

“Sleep is something that we can potentially control. There are plenty of studies that show sleep can affect a person’s health,” she added.

But one cardiologist not involved with the new study cautioned that people should be careful interpreting the findings.

“We haven’t generally thought that missing an hour of sleep causes heart attacks. This may or may not hold up,” said Dr. Steven Nissen, chair of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic.

This is not the first study, however, to find a connection between semiannual time shifts and heart attack rates.

A 2008 Swedish report, for instance, found the chance of a heart attack increased in the first three weekdays after the switch to daylight savings time, and decreased the Monday after the clocks returned to standard time in the fall. (See Reuters Health article of October 30, 2008. reut.rs/Z6cSH2)

Jiddou told Reuters Health that her team, which published its findings in The American Journal of Cardiology, wanted to see if their respective hospitals experienced the same increase and decrease in heart attacks seen in the Swedish study.

For the new work, she and her colleagues reviewed records for the 328 patients who were diagnosed with a heart attack during the week after a time change between 2006 and 2012, and for the 607 heart attack patients who were treated two weeks before and after the time shifts.

They found that except for the small increase on the Sunday that daylight savings time kicked in, there were no significant differences in heart attack rates in the first week after the spring clock change or in the fall, when people set clocks back. The authors note, however, that the small trends they observed suggest shifts to and from daylight savings time may be linked with small increases in heart attacks in the spring, and small decreases in the fall.

They speculate that sleep-deprivation resulting from the time changes could raise levels of stress hormones and inflammatory chemicals just enough to trigger a heart attack, especially in those already at high risk.

Though the slight increase in heart attacks in the days following time shifts were so small they could have been due to chance, Jiddou told Reuters Health that she believes the problem was the size of the study population.

“(The findings) weren’t significant, but I think a lot of that is just because we didn’t have the numbers,” Jiddou.

“The numbers aren’t necessarily striking, but the trends make you stop and think,” she added.

Nissen told Reuters Health that the study looks at a good question and that he applauds the researchers’ efforts, but stressed the limitations of the results.

“Whenever you do this type of study you worry whether it’s by chance or not,” he said. “The size of the effect is not huge even though I realize the data on the first day seems worse.”

Jiddou said she doesn’t think the average person should be overly concerned, “but I think it’s something that they should be aware of.”

SOURCE: bit.ly/W391bW The American Journal of Cardiology, online December 10, 2012.

Jamie Lynn Steffi Graf

Lundbeck’s alcohol dependency drug wins EU green light

Lundbeck’s alcohol dependency drug wins EU green light

Dec 15
A customer takes a bottle of vodka from a shelf at a Russian supermarket in Benidorm, November 26, 2012. REUTERS/Heino Kalis

A customer takes a bottle of vodka from a shelf at a Russian supermarket in Benidorm, November 26, 2012.

Credit: Reuters/Heino Kalis

LONDON | Fri Dec 14, 2012 4:04pm EST

(Reuters) – A novel drug to fight alcohol dependency was given a green light by European regulators on Friday, providing a boost to Danish drugmaker Lundbeck at a time when its top product faces a big drop in sales.

The European Medicines Agency (EMA) said on Friday it recommended approval of Selincro in conjunction with counseling for the reduction of alcohol consumption in adults dependent on drink.

Recommendations from the EMA are normally endorsed by the European Commission within two or three months, implying the drug could be launched in Europe early next year.

That is good news for Lundbeck, which needs new drugs to replace lost sales from antidepressant Cipralex, sold as Lexapro in the United States and Japan, which is now coming off patent.

Alcohol abuse is theoretically a vast market, although it is unclear whether doctors will be ready to prescribe a drug as a treatment and whether Lundbeck has the marketing muscle to make a big impact.

Lundbeck Chief Executive Ulf Wiinberg told Reuters last week that Selincro was “a bit of a joker in our portfolio” because of uncertainty as to how it will be used in practice.

The drug, which blocks the action of opioid receptors in the brain, was licensed to Lundbeck from Finland’s Biotie Therapies and shares in Biotie jumped as much as 16 percent on the news, while Lundbeck rose around 1 percent.

“Clearly, the news is a much-needed boost to sentiment for the (Lundbeck) shares,” said Deutsche Bank analyst Tim Race.

“However, we suspect the market will refrain from pricing-in significant upside from the drug given uncertainties in reimbursement and Lundbeck’s ability to penetrate this market without a major partner.”

Race said current consensus forecasts suggested modest sales of 540 million Danish crowns ($95 million) in 2016.

More important for Lundbeck will be the verdict from regulators in North America and Europe late next year on a new antidepressant being developed with Japanese partner Takeda Pharmaceutical that analysts see as a potential $1-2 billion-a-year seller.

Developing new treatments for depression has proved an uphill battle for drugmakers in recent times but vortioxetine has produced encouraging clinical trial results and its unique mode of action and flexible dosing could make it a winner.

Another approval prospect for next year is Abilify Maintena, a once-monthly version of schizophrenia drug Abilify that Lundbeck is working on with Otsuka.

Further out, Lundbeck is also developing a drug for the symptoms of Alzheimer’s that will be ready to go into final-stage clinical testing next year and could be partnered with a larger drug company.

(Reporting by Ben Hirschler; Editing by Chris Wickham and Mark Potter)

Michelle Branch Sonia Couling

Girl, 8, with face tumour the size of a football to have life-saving surgery before it strangles her

Girl, 8, with face tumour the size of a football to have life-saving surgery before it strangles her

Dec 15

  • Trinny suffers from a severe form of bone disease called Fibrous dysplasia
  • The tumour is benign but has grown so quickly it has blinded her in one eye and threatens to strangle her if no action is taken
  • Mother has praised her daughter who has bravely dealt with condition for half her lifetime

By Claire Bates

|

An eight-year-old girl with a football-sized facial tumour is to have pioneering surgery before it strangles her.

The rare growth first appeared when Trinny Amuhirwe was four-and-a-half, and she twice underwent surgery in her home country of Uganda to remove it.

However, each time the bone tumour has grown back more quickly and it now weighs 4.4lbs.

Scroll down for video

Trinny (aged three months left) has had two operations to tackle her facial tumour. She is pictured (right) after her second operation in September 2011 in Uganda

Since then Trinny has lost sight in one eye due to the swelling and her teeth are being pushed out of place.

THE RARE DISORDER THAT REPLACES BONE WITH SCAR TISSUE

Fibrous dysplasia is a rare bone disease that destroys and replaces normal bone with fibrous (scar-like) tissue.

As the bone grows, the softer, fibrous tissue expands, weakening the bone and making it more prone to fractures.

One or more bones can be affected and it can vary in severity.

Mild cases usually cause no signs or symptoms and develops during the teens.

More-serious cases of fibrous dysplasia may result in bone pain and deformity and are more common in under-10s.

There is no cure for fibrous dysplasia. Treatment focuses on treating signs and symptoms.

The bone lesions may stop when the child reaches puberty.

NIH/Mayo Clinic

Now she will undergo a pioneering surgery at the Cromwell Hospital in London. British experts will attempt to remove all of the benign tumour using the latest technology before reconstructing her face.

The 15-hour operation was made possible by UK charity Facing the World, who flew Trinny and her mother Sarah, 30, from Uganda to the UK for treatment.

Graham Banton, director of Facing the World, said: ‘This is a massive operation undertaken by some of the best surgeons in the world.

‘We hope to be able to remove all the infected bone tissue which will save Trinny’s life and give her back her sight.

‘Using advanced diagnostic and mapping techniques our doctors were able to pinpoint precisely the size and depth of the tumour.

‘Without treatment there would be no hope for Trinny, but thanks to the generosity of our patrons and the expertise of our surgeons, she has a chance.’

Trinny has Fibrous dysplasia – a bone disease that destroys and replaces normal bone with fibrous bone tissue.

Mrs Amuhirwe says over the years she has watched her daughter’s face become almost unrecognisible.

Trinny stands outside Buckingham Palace in London. She flew to London with her mother for surgery thanks to the charity Facing the World

Trinny stands outside Buckingham Palace in London. She flew to London with her mother for surgery thanks to the charity Facing the World

 Trinny Amuhirwe and Sarah

Trinny Amuhirwe and Sarah

The mother-of-three said: ‘In the beginning it was like a small piece of bone sticking out of her face.

‘I thought it would eventually disappear – but it continued to grow. After the first operation the tumour grew back in just two months.

‘Since then it’s taken over her face. I can’t bear to see her like this but she’s been so brave about it.’

Following surgery the schoolgirl will be sedated and moved into intensive care – estimated to cost around £65,000.

All surgeons involved are giving their time free of charge and Facing the World are paying for all of Trinny and Sarah’s living cost – but are entirely dependent on public donations.

Each year Facing the World help up to eight children with extreme facial disfigurements from all over the world. 

The charity was founded in 2002 by two craniofacial surgeons Martin Kelly and Norman Waterhouse after Mr Kelly met a young girl in need while volunteering in Afghanistan.

To donate visit www.facingtheworld.net

VIDEO: Girl with face tumour size of football comes to UK for life-saving surgery 

Kim Cooper Nicole Richie

Los Angeles Sample Sales

Los Angeles Sample Sales

Dec 15
Rachel Pally Warehouse Sale

Big Star Friends & Family Sale

Alyssa Milano Emma Watson

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