Durata's anti-infective drug shows efficacy, safety -FDA panel

(Reuters) – Durata Therapeutics Inc’s drug to treat acute bacterial skin infections shows substantial evidence of safety and efficacy, a panel of advisers to the U.S. Food and Drug Administration concluded on Monday.

The panel voted unanimously in favor of the drug, dalbavancin, paving the way for its approval. The FDA is not obliged to follow the advice of its expert panels but typically does so.

(Reporting by Toni Clarke in Washington; Editing by Peter Cooney)

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Nursing body faces Mid-Staffs censure

By Dominic Hughes
Health correspondent, BBC News

NurseThe NMC is the regulator for the nursing profession

The Nursing and Midwifery Council is facing more criticism over its handling of disciplinary cases in a report by the Professional Standards Authority.

In particular, the report highlights failings over the handling of cases relating to the scandal-hit Mid-Staffordshire NHS Trust.

Investigations were poor, decision-making flawed and record-keeping lax, says the PSA.

The NMC is responsible for regulating 673,000 nurses and midwives in the UK.

It has previously been accused of failing to protect patients and has admitted “substantial failings” in the past – but says the latest report recognises the progress it has made.

The report by the PSA – the body that oversees health regulators – shows the Nursing and Midwifery Council is struggling to move on from its troubled past.

A huge backlog of cases and long delays led to accusations that it was failing at every level.

‘Ongoing weakness’

This latest report saw the PSA carry out an audit of 100 cases dealt with by the NMC’s disciplinary committee.

The report acknowledged that there had been some improvements under a new management team at the NMC, but outlines a number of areas where the organisation is still failing.

The report adds that there is an ongoing weakness in the NMC’s ability to identify for itself where improvements are needed.

The PSA said: “We were disappointed that the NMC’s internal review (in July 2013) of its handling of cases that involved registrants employed by Mid Staffordshire NHS Foundation Trust did not identify a number of serious issues that we picked up in our audit.”

The report also highlighted concerns over the use of voluntary removal, where a nurse or midwife facing a disciplinary hearing can apply to be removed from the register without a full public hearing.

“We identified concerns in all 21 of the cases we audited that were closed following the grant of applications for voluntary removal, and have urged the NMC’s Council to ensure that our concerns about the NMC’s procedures are addressed quickly.”

‘Letting down patients’

Chief executive and registrar of the NMC Jackie Smith said she was pleased the report highlighted the improvements made to the way the disciplinary process for nurses and midwives works.

“We know that there is still more we need to do,” she said.

“However, it recognises the progress we have made and confirms the commitment we made to improving performance.”

But Katherine Murphy, chief executive of the Patients Association, described the findings as “deeply worrying”.

“Delays in processing hearing cases and seeking interim orders would result in incompetent staff continuing to provide poor care to patients.

“The NMC is letting down those patients who have received substandard care from these incompetent care professionals who are free to continue to practice.

“It is disgraceful to see that lessons are still not being learnt from the Francis Inquiry and serious issues relating to registrants from the Mid Staffordshire trust have not been picked up.

“The Regulator needs to address these fundamental issues now and act urgently to protect the public.”

Campaigner Julie Bailey of Cure The NHS said it was time to accept that the NMC was “not fit for purpose”

“The public expect patients to be protected and this is another instance where the NMC have failed us.

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Smokers may show heart disease much younger than nonsmokers

A man flicks ashes from his cigarette over a dustbin in Shanghai January 10, 2014. REUTERS/Aly Song

A man flicks ashes from his cigarette over a dustbin in Shanghai January 10, 2014.

Credit: Reuters/Aly Song

(Reuters Health) – A smoker’s coronary artery disease is likely to be as advanced as that of a non-smoker who is 10 years older when both show up at the hospital with a heart attack, according to a new study.

Researchers looked at nearly 14,000 patients hospitalized with blockages in arteries supplying the heart muscle and found smokers were more likely than nonsmokers to die within a year.

Despite their being younger, and otherwise healthier, the smokers’ heart arteries were in a condition similar to those of nonsmokers 10 years older.

“We saw smokers presenting the disease at age 55 and nonsmokers presenting the same disease at 65,” said Dr. Alexandra Lansky, a researcher on the study.

Smoking can cause blood clots, which often get lodged in the rigid and narrow arteries that have already been clogged by the buildup of cholesterol and fat deposits, according to Lansky and her colleagues.

Although the fat buildup and stiffening of the artery walls, known as atherosclerosis, becomes more likely with age for everyone, the clots caused by smoking worsen the blockages.

That makes smokers more likely to have a heart attack at a younger age, but less likely to have the other conditions, known as comorbidities, that go along with aging, such as diabetes and high blood pressure.

“Smoking accelerates the manifestation of coronary disease but in the absence of these comorbidities,” Lansky told Reuters Health.

Past research has identified a “smoker’s paradox” – because smokers are younger, with fewer other health problems, when they had a heart attack, they were more likely to recover it. Or so it seemed.

“We wanted to look at longer-term effects of smoking rather just the short term effect,” Lansky said.

The researchers analyzed medical records for 13,819 patients, almost 4,000 of them smokers, hospitalized with chest pain or a heart attack caused by a blocked coronary artery.

The study team organized the data to match the smokers and nonsmokers by age, weight, comorbidities and other risk factors.

When compared to nonsmokers with similar overall health, the smokers were ten years younger, on average, and more likely to have already been treated with blood thinners – suggesting they had already experienced problems with blood flow.

Imaging of the coronary artery showed the smokers’ had atherosclerosis comparable to the nonsmokers ten years their senior, the researchers report in the journal JACC: Cardiovascular Interventions.

Before the adjustments for age and other health conditions, the smokers and nonsmokers were about equally likely to survive the first 30 days after hospitalization, and smokers were about 20 percent less likely to die within a year.

But once smokers and nonsmokers with similar health profiles were compared to each other, the smokers were 37 percent more likely to die within the first year.

“What makes it novel, is that we are showing that if you come in, your chance of survival is already reduced, as a smoker,” Lansky said.

The findings are not surprising, according to Dr. Robert Giugliano, a cardiologist at Brigham and Women’s Hospital in Boston.

“Nonetheless, the public does need to know that there is now even more evidence that smoking is bad for your health, accelerates the process of atherosclerosis (so smokers have heart and vascular disease on average 10 years early than non-smokers), and leads to worse outcomes compared to non-smokers of a similar age,” said Giugliano, who also teaches at Harvard Medical School.

Dr. Elliot Antman, also of Brigham and Women’s Hospital and Harvard, said it would be interesting to follow the patients for longer than a year to see what happened to survival rates among smokers who quit.

Antman was not surprised by the findings either. “I always suspected this was the case but it is nice to see the data,” he told Reuters Health.

“There just aren’t many healthy people in their 80’s who smoke regularly . . . if you want to live a healthy, long life, smoking stacks the odds against you,” Giugliano said.

SOURCE: bit.ly/1g8o9sK JACC: Cardiovascular Interventions, online March 14, 2014.

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Obamacare website stalls briefly ahead of enrollment deadline

Julissa Esparza, 2, sleeps in the arms of her grandfather Leobardo Salazar, 58, as they wait in line at a health insurance enrollment event in Cudahy, California March 27, 2014. REUTERS/Lucy Nicholson

Julissa Esparza, 2, sleeps in the arms of her grandfather Leobardo Salazar, 58, as they wait in line at a health insurance enrollment event in Cudahy, California March 27, 2014.

Credit: Reuters/Lucy Nicholson

(Reuters) – The website for people to enroll in U.S. private health insurance faced some delays early Monday morning, just hours before the deadline for the first year of enrollment under the healthcare law.

The HealthCare.gov technology team has begun bringing the site back on line gradually after it found a software bug during their monitoring of the site and fixed it during the regular maintenance window, representatives for the Department of Health and Human Services said in a statement.

A spokeswoman said the site was functioning again.

The agency said the website, which has been plagued by controversial technical problems since it launched in October, “has handled record consumer demand well. “Over the weekend, the site saw 2 million visits,” the government said, and more than 8.7 million visits during the past week.

HealthCare.gov launched in October and quickly crashed. It worked intermittently until a technology overhaul had it working relatively smoothly by December. While the consumer facing part of the site has been working in recent months, there are still some parts of the back-end systems that remain unbuilt.

Americans have until midnight on Monday to obtain health insurance under President Barack Obama’s healthcare law known as Obamacare or else face fines. The administration has softened the deadline to accommodate those who attempt to apply for coverage by Monday night but run into technology issues.

Efforts to access the website Monday morning first generated a message saying “the system isn’t available at the moment” due to “maintenance.” A later attempt cited a delay because of a heavy number of visitors, but then allowed a visitor to start creating an account.

In the statement, representatives for the department said people who visit the insurance exchange website can leave their contact information and enroll online later, or call a hotline to complete their applications.

They said that consumers will be invited back in when the system is available.

On Sunday, the Centers for Medicare and Medicaid Services, the agency charged with overseeing the website, said the online exchange has seen a rush of potential enrollees as the deadline window closes.

The government has said that more than 6 million people have enrolled for healthcare through the website.

(Reporting by Susan Heavey and Caroline Humer in New York; Editing by Bill Trott, Chizu Nomiyama and Sofina Mirza-Reid)

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Are statins good for your love life?

Statins are associated with a significant improvement in erectile function, a fact researchers hope will encourage men who need statins to reduce their risk of heart attack to take them, according to research. “The increase in erectile function scores with statins was approximately one-third to one-half of what has been reported with drugs like Viagra, Cialis or Levitra,” said an author.

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Study on effects of cholesterol-lowering medications on sexual health

A new study is giving hope to older men who are concerned about the effects of cholesterol-lowering medications on their sexual health. The study by researchers at Rutgers Robert Wood Johnson Medical School indicates that statin medication prescribed to lower cholesterol and decrease the chance of having a heart attack and stroke, also improves a man’s erectile function. The investigators presented their findings today at the American College of Cardiology‘s Annual Scientific Session and simultaneously released the study in The Journal of Sexual Medicine.

“Older men who have poor cardiovascular health, diabetes or metabolic syndrome often experience erectile dysfunction and the prevalence of these diseases is expected to increase,” said John B. Kostis, MD, professor of medicine, director of the Cardiovascular Institute at Robert Wood Johnson Medical School and the study’s principal investigator. “Our research indicates that statins not only improve cardiovascular health and reduce the risk of stroke and heart attack, but also improve erectile function in the men included in our analysis.”

Dr. Kostis suggested that ED may serve as a warning sign of cardiovascular disease. “Similar to a canary in a coal mine,” he said.

In such patients, prescribing statins following the detection of cardiovascular disease could offer early benefits in addition to improved sexual function. He cautioned, however, that until further study is conducted, statins should not be prescribed for erectile dysfunction alone or when it may be caused by psychosocial factors. Kostis added that further study is needed to determine the link between statin therapy and the improvement of erectile function.

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Popular cholesterol-lowering drugs may offer added benefit for men with erectile dysfunction

Statins are associated with a significant improvement in erectile function, a fact researchers hope will encourage men who need statins to reduce their risk of heart attack to take them, according to research to be presented at the American College of Cardiology‘s 63rd Annual Scientific Session.

Erectile dysfunction is common in older men, especially among those with cardiovascular risk factors where cholesterol-lowering statins are frequently prescribed. Previous research has suggested a negative association between statin therapy and testosterone levels, leading to questions about the effects of these widely used medications on the quality of erection.

In the first meta-analysis of previous studies on erectile dysfunction and statins, researchers identified 11 randomized, controlled trials that measured erectile function using the International Inventory of Erectile Function – a self-administered survey with five questions, each scored on a five-point scale and totaled, with lower values representing poorer sexual function. Analysis of all 11 studies combined found a statistically significant effect of statins on erectile function in men who had both high cholesterol and erectile dysfunction. Overall, erectile function scores increased by 3.4 points in men who took statins (from 14.0 to 17.4, a 24.3 percent increase).

“The increase in erectile function scores with statins was approximately one-third to one-half of what has been reported with drugs like Viagra, Cialis or Levitra,” said John B. Kostis, M.D., director of the Cardiovascular Institute and associate dean for Cardiovascular Research at Rutgers Robert Wood Johnson Medical School, and the lead investigator of the study.

“It was larger than the reported effect of lifestyle modification,” Kostis said. “For men with erectile dysfunction who need statins to control cholesterol, this may be an extra benefit.”

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Newly identified protein markers have potential to contribute to better understanding of heart disease

Researchers at the Intermountain Medical Center Heart Institute in Murray, Utah, have discovered that elevated levels of two recently identified proteins in the body are inflammatory markers and indicators of the presence of cardiovascular disease.

These newly identified markers of inflammation, GlycA and GlycB, have the potential to contribute to better understanding of the inflammatory origins of heart disease and may be used in the future to identify a heart patient’s future risk of suffering a heart attack, stroke, or even death.

Inflammation occurs in the body in response to tissue damage, irritation, or infection. Inflammation is often associated with injury (i.e., sprained ankle), infection (i.e., strep throat), and auto-immune diseases (i.e., rheumatoid arthritis). However, it has been shown that inflammation is also a risk factor for heart disease.

“There are at least two benefits evident from this study,” said J. Brent Muhlestein, MD, lead researcher and co-director of cardiovascular research at the Intermountain Medical Center Heart Institute. “First, a new marker of heart attack or stroke may help us to more effectively identify which patients are at risk. Second, now that we know GlycA and GlycB are important predictors of heart disease, we’ll seek to understand more about the physiology of these proteins – what causes them to increase and how we can we treat elevated levels.”

Levels of GlycA and GlycB were determined from a blood test called nuclear magnetic resonance (NMR) spectroscopy, which was developed to determine the number of lipid particles contained in different cholesterol parameters.

Testing for GlycA and GlycB by NMR spectroscopy uses signals that arise from the binding of glucose molecules to a variety of circulating inflammatory proteins, especially fibrinogen, a1-antichymotrypsin, haptoglobin-1, a1-antitrypsin, complement C3 and a1-acid glycoprotein.

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Ancient rheumatism drug reduces recurring inflammation around heart

(Reuters) – A drug that was used in the time of the pharaohs for rheumatism has proven highly effective in treating recurrent bouts of pericarditis, an inflammation of the sac surrounding the heart, according to findings of a new clinical trial.

The ancient medicine, colchicine, which has also been used for centuries as an anti-inflammatory agent for acute gout, was tested against placebo in a 240-patient pericarditis trial.

The rate of recurring pericarditis was nearly halved for those taking colchicine compared with placebo, according to data presented on Sunday at the annual scientific sessions of the American College of Cardiology in Washington. The condition, which causes sharp chest pain, recurred in 42.5 percent of those taking dummy pills, compared with 21.6 percent of those who got colchicine.

Moreover, after three days of treatment, 19.2 percent of patients taking the drug had symptoms, compared with more than 44 percent of those given placebos. And those taking placebos, on average, had 0.63 recurrences, compared to 0.28 recurrences for those on colchicine.

With such fewer recurrences, the drug reduced the rate of hospitalizations to 1.7 percent, from 10 percent in the placebo group, potentially cutting healthcare costs at a time when pressure is mounting to limit costly hospital readmissions.

Although colchicine has been used for decades to treat pericarditis, following favorable trends seen in earlier trials, this was the first large formal multi-center study to examine use of the drug for multiple recurrences of the condition.

The favorable results will increase confidence in use of the medicine for pericarditis, researchers said.

Patients in the study received 0.5 milligrams of the drug either once or twice daily depending on their weight in addition to commonly used anti-inflammatory drugs such as aspirin or ibuprofen.

No serious side effects were associated with use of colchicine, researchers said, but gastrointestinal issues were reported in about eight percent of patients.

The reasons for pericarditis that repeatedly recurs once the original cause has been treated are not well understood, but potential causes are infections, kidney disease, cancer and heart surgery, researchers said.

“Health care providers should feel confident with the use of colchicine as a first line drug in patients with multiple recurrences of pericarditis,” both for its safety and effectiveness, said Dr. Massimo Imazio, a cardiologist with Maria Vittoria Hospital in Torino, Italy, who led the trial.

Imazio said the study affirms that colchicine can be added to traditional treatments, such as anti-inflammatories and corticosteroids, and thereby provide an affordable treatment with few side effects.

(Reporting by Ransdell Pierson and Bill Berkrot; Editing by Diane Craft)

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'Step forward' in skin cancer fight

By Helen Briggs
BBC News

MoleFor most people avoiding sunburn and sunbeds is the best way to reduce risk, says Cancer Research UK

Scientists say they have taken a step forward in understanding why some people are at greater risk of skin cancer because of their family history.

A newly identified gene mutation causes some cases of melanoma, a type of skin cancer, says a UK team.

The discovery will pave the way for new screening methods, they report in Nature Genetics.

The risk of melanoma depends on several factors, including sun exposure, skin type and family history.

Every year in the UK, almost 12,000 people are diagnosed with melanoma.

About one in 20 people with melanoma have a well-established family history of the disease.

A team led by the Wellcome Trust Sanger Institute in Hinxton, UK, found that people with mutations in a certain gene were at extremely high risk of melanoma.

The mutations switch off a gene known as POT1, which protects against damage to packets of DNA, known as chromosomes.

Co-author Dr David Adams, from the Wellcome Trust Sanger Institute, said the discovery should lead to the ability to find out who in a family was at risk, and who should be screened for skin cancer.

He told the BBC: “The mutations in this gene result in damage to the end of the chromosomes and chromosomal damage in general is linked to cancer formation – that’s the pathway for it.”

Early detection

A number of gene mutations have been identified as increasing the risk of melanoma, but others remain unknown.

Prof Tim Bishop, Director of the Leeds Institute of Cancer and Pathology, said the finding increased understanding of why some families had a high incidence of melanoma.

“Since this gene has previously been identified as a target for the development of new drugs, in the future it may be possible that early detection will facilitate better management of this disease,” he said.

The team found cancers such as leukaemia were common in these families, suggesting the gene may underlie other cancers and not just melanoma.

Dr Safia Danovi of Cancer Research UK said: “This is a step forward for people with a strong family history of melanoma, the most dangerous form of skin cancer.

“But it’s important to remember that, for most of us, avoiding sunburn and sunbeds is the best way to reduce the risk of this disease.”

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