Drug resistance 'global threat'

By Pippa Stephens
Health reporter, BBC News

Lab research into new antibioticsWHO called for more preventative measures against infection

Resistance to antibiotics poses a “major global threat” to public health, says a new report by the World Health Organization (WHO).

It analysed data from 114 countries and said resistance was happening now “in every region of the world”.

It described a “post-antibiotic era”, where people die from simple infections that have been treatable for decades.

There were likely to be “devastating” implications unless “significant” action was taken urgently, it added.

The report focused on seven different bacteria responsible for common serious diseases such as pneumonia, diarrhoea and blood infections.

It suggested two key antibiotics no longer work in more than half of people being treated in some countries.

One of them – carbapenem – is a so-called “last-resort” drug used to treat people with life-threatening infections such as pneumonia, bloodstream infections, and infections in newborns, caused by the bacteria K.pneumoniae.

Bacteria naturally mutate to eventually become immune to antibiotics, but the misuse of these drugs – such as doctors over-prescribing them and patients failing to finish courses – means it is happening much faster than expected.

The WHO says more new antibiotics need to be developed, while governments and individuals should take steps to slow this process.

In its report, it said resistance to antibiotics for E.coli urinary tract infections had increased from “virtually zero” in the 1980s to being ineffective in more than half of cases today.

In some countries, it said, resistance to antibiotics used to treat the bacteria “would not work in more than half of people treated”.

Gonorrhoea treatment ‘failure’

Dr Keiji Fukuda, assistant director-general at WHO, said: “Without urgent, coordinated action by many stakeholders, the world is headed for a post-antibiotic era, in which common infections and minor injuries which have been treatable for decades can once again kill.”

E.coli bacteriaUrinary tract infections caused by E.coli bacteria are becoming harder to treat

He said effective antibiotics had been one of the “pillars” to help people live longer, healthier lives, and benefit from modern medicine.

“Unless we take significant actions to improve efforts to prevent infections and also change how we produce, prescribe and use antibiotics, the world will lose more and more of these global public health goods and the implications will be devastating,” Dr Fukuda added.

The report also found last-resort treatment for gonorrhoea, a sexually-transmitted infection which can cause infertility, had “failed” in the UK.

It was the same in Austria, Australia, Canada, France, Japan, Norway, South Africa, Slovenia and Sweden, it said.

More than a million people are infected with gonorrhoea across the world every day, the organisation said.

‘Wake-up call’

The report called for better hygiene, access to clean water, infection control in healthcare facilities, and vaccination to reduce the need for antibiotics.

Last year, the chief medical officer for England, Prof Dame Sally Davies, said the rise in drug-resistant infections was comparable to the threat of global warming.

Dr Jennifer Cohn, medical director of Medecins sans Frontiers’ Access Campaign, said: “We see horrendous rates of antibiotic resistance wherever we look in our field operations, including children admitted to nutritional centres in Niger, and people in our surgical and trauma units in Syria.

“Ultimately, WHO’s report should be a wake-up call to governments to introduce incentives for industry to develop new, affordable antibiotics that do not rely patents and high prices and are adapted to the needs of developing countries.”

She added: “What we urgently need is a solid global plan of action which provides for the rational use of antibiotics so quality-assured antibiotics reach those who need them, but are not overused or priced beyond reach.”

Professor Nigel Brown, president of the UK Society for General Microbiology, said it was vital microbiologists and other researchers worked together to develop new approaches to tackle antimicrobial resistance.

“These approaches will include new antibiotics, but should also include studies to develop new rapid-diagnostic devices, fundamental research to understand how microbes become resistant to drugs, and how human behaviour influences the spread of resistance.”

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Heart Health Poor Among Stroke Survivors


Published: Apr 30, 2014

Less than one out of every 100 stroke survivors met all of the American Heart Association’s criteria for ideal cardiovascular health, researchers found.

The percentage of patients who met none or only one of the seven goals used to define ideal cardiovascular health increased from 18% in 1988-1994 to 33% in 2005-2010, and less than 1% achieved all seven goals, according to Michelle Lin, MD of the University of Southern California in Los Angeles.

The participants improved in some metrics over time, but worsened or remained stable in most, Lin reported at the annual meeting here of the American Academy of Neurology.

The seven health metrics — dubbed Life’s Simple 7 — were developed in 2010 by the American Heart Association, Lin noted. They include:

  • Having a total cholesterol of less than 200 milligrams per deciliter.
  • Having blood pressure below 120/80.
  • Having a fasting blood glucose below 100 milligrams per deciliter.
  • Having either never smoked, or quit more than a year ago.
  • Having a body mass index of less than 25.
  • Exercising at a moderate level for at least 150 minutes, or at an intense level for 75 minutes per week.
  • Meeting four to five of the key components of a healthy diet in line with current heart association guidelines.

To see how stroke survivors match up over time, Lin and colleagues turned to the National Health and Nutrition Examination Survey (NHANES) for 1988-1994, 1999-2004, and 2005-2010.

To be able to use NHANES data, she noted, they modified the Simple 7 criteria in some cases. For instance, because NHANES investigators did not collect data on when participants quit smoking, Lin and colleagues defined them as simply current, former, or never smokers.

Over the three periods, she reported, the researchers found 1,293 stroke survivors with data for all seven metrics.

But, she said, less than 1% achieved an ideal score on all seven metrics — only two participants, both in the 2005-2010 period.

The proportion with metric scores of four or higher was stable over time — about 17% or 18% in each period, Lin reported — while the proportion of people with scores of two or three improved significantly over time (at P=0.01).

But that was because the proportion of people with a metric score of zero or one climbed sharply — 18% in 1988-1994, 24% in 1999-2004, and 33% in 2005-2010. The trend was significant at P=0.0007.

On the positive side, a comparison of survivors in 1988-1994 and 2005-2010 showed significant improvements in all three medical metrics.

The proportion of people with the worst level of cholesterol, for instance, fell from 37% to 16%, Lin said.

But the lifestyle metrics were a different story. The proportion who were overweight and weren’t eating a healthy diet rose significantly (at P<0.001 and P=0.004, respectively) while the proportion of never smokers and those with good exercise habits stayed stable.

The study “gives us a baseline for how badly we do at primary prevention,” commented Cheryl Bushnell, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., who was not part of the study but who moderated a session at which it was presented.

The seven health metrics are a recent development, she told MedPage Today, and it will be interesting to see how they influence stroke survivors in the future.

But for many of the people whose illness was recorded in the data, “a poor health score is why they had a stroke in the first place.”

It’s important to note that over time the three medical metrics actually improved, she added, but lifestyle markers either were stable or worsened — a reflection of an increasingly sedentary nation.

From the American Heart Association:

North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers’ Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

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Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Can-Fite BioPharma Ltd. (NYSE MKT:CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it has submitted a study protocol to the U.S. Food and Drug Administration for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer. The FDA has granted Orphan Drug designation to CF102 in this indication. The protocol, which has already been approved by the Institutional Review Board (IRB) in Israel, will also be filed in Europe.

The planned Phase II study will be conducted in Israel, Europe and the U.S. with 78 subjects who will be dosed with CF102 as a second-line treatment of advanced hepatocellular carcinoma (HCC) with Child-Pugh Class B cirrhosis. The study will investigate the efficacy and safety of CF102 as compared to placebo.

Dr. Keith Stuart, MD, assisted in developing the study protocol. He is Chairman, Department of Hematology at Lahey Clinic and Oncology Professor of Medicine, Tufts University School of Medicine. Tufts University will participate as the study’s U.S. clinical site.

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MPs want newborn muscle disease test

By Pippa Stephens
Health reporter, BBC News

Muscles with DuchenneDuchenne muscular dystrophy affects one in 3,500 newborn boys in the UK

A group of MPs is urging the government to allow the testing of newborn boys for a deadly muscle wasting disease.

Duchenne muscular dystrophy (DMD) affects one in every 3,500 newborn boys, and many will die before age 30.

Although a test exists, it is not used to check for the disorder at birth in the UK.

Opponents say the test is too unreliable and that with no effective treatment on offer, screening is inappropriate.

Duchenne muscular dystrophy can become fatal when it affects the muscles needed to breathe and pump blood around the body.

Those with the condition can need a wheelchair by the age of 10.

Testing before a cure?

The current average age of diagnosis for the disease was five years old, said the Muscular Dystrophy Campaign, by when a child would have lost 30-40% of their muscle mass.

Doctors currently rely on family history, symptoms, blood, nerve and muscle tests, and muscle biopsies to diagnose the condition.

But it can be detected with a simple blood test, in some instances at birth.

An inquiry into testing for the condition has been led by the All Party Parliamentary Group for Muscular Dystrophy. While the MPs agree that the DMD test needs perfecting, they say current screening rules are too prohibitive and prevent newborn screening for the disease.

The group said the criteria governing testing for DMD stated symptoms should be present at birth in order for any newborn screening test to be considered.

But it said it “may always be particularly hard” for the disorder to meet this, as symptoms often appeared later in childhood.

The criteria also stated there “should be an effective treatment for patients identified through early detection”, but the group said families whose children had DMD said they would want a test even without a treatment.

The report said families would rather know so they could prepare, by finding schools, changing their housing, and arranging treatment.

MPs said the first treatments for the disorder were in the final stages of trials and called for the rules to be reconsidered. A treatment could be available in the US as early as 2015.

A test could be available in five years, said the Muscular Dystrophy Campaign.

Not knowing

The Muscular Dystrophy Campaign said there was a risk that without early testing, parents would not know if they were a carrier for the gene linked to DMD and so could go on to have several more children with DMD.

A newborn DMD blood test available in Wales from 1990 to 2011 had been withdrawn due to inaccuracies, and in 2012 the UK National Screening Committee had decided not to introduce it across the UK, said the report.

Jane Field’s son, Murray, 16, has DMD. She told the BBC he had been seven by the time the family had realised he had the disorder after three and a half years of misdiagnoses.

She said: “I can only say from my point of view that the absolute horror, when you know something is wrong but you don’t know what it is, is absolutely devastating.”

Ms Field said there “absolutely” should be a test even if there was a risk of false positives.

Lacking treatment

“There is never a good time to get this diagnosis. To put it bluntly the screening committee should be supporting work on a more accurate Duchenne test for newborns. It is already being done in the US,” she added.

Dr Anne Mackie, director of programmes at the UK National Screening Committee, told the BBC misdiagnosis had been an issue when the test was run in Wales.

She said: “My duty is to make sure if we do recommend a test to parents, that it is a really good one. But that also we are able to say to parents of a positive test, ‘This is what we can do for you and it will make a difference.'”

Dr Mackie said one of the “major problems” was the treatments were “not as good” as the committee would “wish them to be”.

She added: “I know the APPG is pushing for improvements in tests and there are some exciting developments, but for the moment, we can’t say hand on heart if your baby has this test, this will happen and we can help.”

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Amicus Therapeutics rare disease drug effective in trial

(Reuters) – Amicus Therapeutics Inc said its experimental drug significantly reduced the abnormal accumulation of fat in body cells related to a rare genetic disorder that could lead to heart attack, stroke and kidney failure.

The company, whose shares rose as much as 36 percent, said it would file for U.S. marketing approval based on these results and those from an European trial, expected in the third quarter.

The late-stage trial evaluated the drug, migalastat, as a form of monotherapy for certain Fabry disease patients after 12 months of treatment.

The 24-month study began with a 6-month period where patients received either the drug or a placebo. All patients were then treated with migalastat for a 6-month follow-up period and a subsequent 12-month extension phase.

After the drug failed to show statistically significant reduction in kidney lipid levels at 6 months, Amicus said it would report 12-month efficacy and safety data to support its marketing application.

“It may be that (the drug) needs more time to work, as shown by today’s results,” Janney Montgomery Scott analyst Kimberly Lee said, adding that the European trial data would provide further evidence of whether the drug needed a longer duration to be effective.

Cowen & Co analyst Edward Nash said migalastat could satisfy the “significant need for an oral therapy for Fabry disease”.

Sanofi SA’s Fabrazyme, the first FDA-approved Fabry treatment, is administered intravenously.

Lee said she expected migalastat’s use as a monotherapy could represent a $250 million global market opportunity and be worth up to double that size as a combination therapy.

Amicus is also testing migalastat in combination with the current standard-of-care for the disease.

GlaxoSmithKline returned the rights to migalastat to Amicus in November 2013.

Fabry disease is an inherited, potentially fatal disorder characterized by the buildup of a particular type of fat – most notably in the kidneys – called globotriaosylceramide, or GL-3, in the body’s cells.

This progressive lipid accumulation, caused by the deficiency of the enzyme a-galactosidase A (a-Gal A), results in cell damage, leading to pain, hearing loss, kidney failure, heart attacks and strokes. As a monotherapy, migalastat works by binding to the a-Gal A enzyme, made in the patient’s body, helping it break down the lipids. The Cranbury, New Jersey-based company’s stock was up about 22 percent at $2.25 in afternoon trading.

(Reporting by Natalie Grover in Bangalore; Editing by Don Sebastian and Sriraj Kalluvila)

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Adhesion molecule offers promising therapeutic target for preventing colitis

May Provide Therapeutic Target for Treating Inflammatory Bowel Disease and Preventing Colitis-Associated Colorectal Cancer, According to New Research Published in The American Journal of Pathology

The adhesion molecule CD146 plays a vital role in inflammation and offers a promising therapeutic target for treating inflammatory bowel disease (IBD) as well as preventing colitis-associated colorectal cancer, say scientists. Targeting CD146 with anti-CD146 antibody AA98, especially in combination with an anti-TNF-alpha antibody, showed promising results in mice. Their report is published in The American Journal of Pathology.

Enhanced CD146 expression has been reported on endothelial cells in intestinal biopsies from patients with inflammatory bowel disease. There have also been clinical observations that CD146 expression is associated with other inflammatory diseases such as rheumatoid arthritis, chronic renal failure, and diabetes. However, the mechanisms were unclear until now.

In the present study, the investigators set out to examine how CD146 functions in inflammatory diseases and, more importantly, to understand its role in chronic-inflammation-associated carcinogenesis. They found that overexpressed endothelial CD146 promoted the inflammatory responses in IBD, which further potentiated the occurrence of colitis-associated carcinogenesis (CAC). “Eliminating endothelial CD146 by conditional knockout in two different mouse models of colitis significantly reduced the severity of inflammation and decreased tumor incidence and tumor progression in a mouse model of CAC,” reports lead investigator Xiyun Yan, PhD, from the Key Laboratory of Protein and Peptide Pharmaceuticals, Institute of Biophysics, Chinese Academy of Sciences, Beijing.

To mimic the long-lasting and relapsing property of IBD, the team also established a chronic colitis mouse model and administrated an anti-CD146 antibody, AA98, after the onset of disease. Because IBD is a clinically heterogeneous disease with complex mechanisms, a combination of drugs targeting distinct biomarkers might be considered as a potential approach. Thus, they also tested the combined treatment of anti-CD146 antibody AA98 and anti-TNF-alpha antibody V1q in this model. Disease activity index and histological score were dramatically reduced in the AA98 treatment group and the V1q treatment group, especially the combination treatment group, compared with the mIgG treatment group.

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E-cigarette users reach 2 million

Ian smoking an electronic cigarette

The BBC’s Graham Satchell observes a university lab test comparing traditional smoking with e-cigarettes

The number of people who use electronic cigarettes in the UK has tripled over the past two years to 2.1 million, a health charity estimates.

It says just over half of current or ex-smokers have now tried electronic cigarettes, compared with 8% in 2010.

Action on Smoking and Health (Ash) surveyed more than 12,000 adult smokers.

A separate study found that most e-cigarette users were using them to reduce smoking.

Use of e-cigarettes among people who have never smoked remains small at 1%, Ash said.

Ash has commissioned a series of surveys on electronic cigarette use since 2010, with the latest survey conducted in March.

Of those now estimated to be using electronic cigarettes, around 700,000 are thought to be ex-smokers and 1.3 million to be using them alongside normal cigarettes or tobacco.

Current smokers using the cigarettes regularly have risen from 2.7% in 2010 to 17.7% in 2014.

When ex-smokers were asked why they used electronic cigarettes, 71% said they wanted help giving up smoking. Among smokers, 48% said wanted to reduce the amount of tobacco they smoked and 37% said they used e-cigarettes to save money.

Smoking rate fall

Deborah Arnott, chief executive of Ash, said: “The dramatic rise in use of electronic cigarettes over the past four years suggests that smokers are increasingly turning to these devices to help them cut down or quit smoking. Significantly, usage among non-smokers remains negligible.”

Another study, The Smoking Toolkit Study, which covers England, has found that electronic cigarettes are overtaking the use of nicotine products such as patches and gum as an aid to quitting smoking.

It also found that the proportion of smokers who gave up smoking in the past year had increased and smoking rates in England were continuing to fall.

Study leader Prof Robert West said: “Despite claims that use of electronic cigarettes risks renormalising smoking, we found no evidence to support this view.

“On the contrary, electronic cigarettes may be helping to reduce smoking as more people use them as an aid to quitting.”

Ms Arnott added: “While it is important to control the advertising of electronic cigarettes to make sure children and non-smokers are not being targeted, there is no evidence from our research that e-cigarettes are acting as a gateway into smoking.”

Ash’s survey suggests that most electronic cigarettes users, or “vapers”, use a rechargeable product with replaceable cartridges or a reservoir.

Simon Clark, director of Forest, a group that supports smokers, said it welcomed the rise of e-cigarettes and was glad people had a choice of what to smoke.

But he suggested that most smokers using e-cigarettes were experimenting with them rather than using them to give up smoking altogether.

“We haven’t seen a significant fall in smokers. Most smokers still find electronic cigarettes quite basic and it will take a few more years for the technology to improve.”

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AstraZeneca rejects Pfizer talks, says confident in strategy

Pedestrians walk past the world headquarters of Pfizer in New York November 5, 2013.    REUTERS/Adam Hunger

(Reuters) – Britain’s AstraZeneca urged its shareholders to take no action over the approach by U.S. drugmaker Pfizer Inc on Monday and said it remained confident in its independent strategy.

Pfizer said earlier on Monday it had made a 58.8 billion pounds ($98.9 billion) bid approach to AstraZeneca in January and had contacted its British rival again on April 26 seeking further discussions about a takeover.

“In this discussion, the Chairman of Pfizer did not make a specific proposal regarding an offer to acquire AstraZeneca,” Astra said.

The British company said it had considered the request for talks, but without a specific and attractive proposal, it had deemed it inappropriate to engage in discussions with Pfizer.

“The board remains confident in the ongoing execution of AstraZeneca’s strategy as an independent company and that its successful delivery will create significant value for shareholders,” it said.

(Reporting by Kate Holton; Editing by Brenda Goh)

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Bayer may sell plastics unit to focus on health: Bloomberg

The logo of Bayer AG is pictured at the Bayer Healthcare subgroup production plant in Wuppertal February 24, 2014. REUTERS/Ina Fassbender

The logo of Bayer AG is pictured at the Bayer Healthcare subgroup production plant in Wuppertal February 24, 2014.

Credit: Reuters/Ina Fassbender

(Reuters) – German drugmaker Bayer AG is exploring the sale of its $10 billion plastics unit to focus on growing its health business, Bloomberg reported citing people with knowledge of the matter.

Bayer is considering the sale of its MaterialScience division after chemicals company Evonik Industries AG showed interest in the unit several months ago, Bloomberg said, adding that no final decision has been made on the plastics unit. (r.reuters.com/pez78v)

Bayer, Germany’s largest drugmaker, in April last year lowered its outlook for its MaterialScience unit, which makes transparent plastics used in sports goggles, DVDs and car lights, as core earnings for the division slumped by more than a quarter.

Polycarbonates, the type of transparent plastic that is Bayer’s specialty, are in ample global supply after lower-cost rivals in the Middle East, mainly Sabic, built new sites.

Bayer was not immediately available for comment outside regular business hours.

(This story corrects the third paragraph to say Bayer lowered its outlook for the MaterialScience unit in April last year, not last Friday)

(Reporting by Arnab Sen in Bangalore; Editing by Gopakumar Warrier)

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Saudi Arabia has 26 more cases of MERS virus, 10 dead

(Reuters) – Saudi Arabia confirmed 26 more cases of Middle East Respiratory Syndrome (MERS), which has killed nearly a third of sufferers, and said 10 more people have died from the disease.

The confirmations follow Egypt’s announcement on Saturday that it had confirmed its first case of MERS in a man who had recently returned to the country from Riyadh, where he was working.

Saudi Arabia, where MERS was discovered around two years ago and which remains the country most affected, has now had 339 confirmed cases of MERS, of which 102 have been fatal.

The 143 cases announced since the start of April represent a 73 percent jump in total infections in Saudi Arabia this month.

The new cases were announced in two statements published on the Health Ministry website on Saturday and Sunday.

The 10 confirmed on Saturday included seven in Jeddah, the focal point for the recent outbreak, two in the capital Riyadh and another in Mecca. Two MERS patients died.

The 16 further cases confirmed on Sunday included two in Riyadh, eight in Jeddah and another six in the northern city of Tabuk. Eight MERS sufferers died on Sunday.

The acting health minister, Adel Fakieh, said on Saturday he had designated three hospitals in Riyadh, Jeddah and Dammam on the Gulf coast as specialist centres for MERS treatment.

The three hospitals can accommodate 146 patients in intensive care, he said in comments carried by local press on Sunday.

Many Saudis have voiced concerns on social media about government handling of the outbreak, and last week King Abdullah sacked the health minister.

In Jeddah, some people are wearing facemasks and avoiding public gatherings, while pharmacies say sales of hand sanitisers and other hygiene products are soaring.

(Reporting by Angus McDowall; Editing by Kim Coghill and Sonya Hepinstall)

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