U.S. FDA approves J&J, Pharmacyclics lymphoma drug

U.S. health regulators on Wednesday approved a drug to treat a rare and aggressive form of non-Hodgkin lymphoma developed by Johnson & Johnson and Pharmacyclics Inc, becoming the second drug that had received the FDA’s new breakthrough therapy designation to gain approval.

The drug, to be sold under the brand name Imbruvica, and known chemically as ibrutinib, was approved to treat mantle cell lymphoma in patients who have received prior treatment with at least one other medicine, such as Celgene Corp’s Revlimid. It works by inhibiting an enzyme needed by the cancer to multiply and spread.

Mantle cell lymphoma, which represents about 6 percent of non-Hodgkin lymphoma cases in the United States, has typically spread to lymph nodes, bone marrow and other organs by the time it is diagnosed, the Food and Drug Administration said.

The FDA earlier this month approved Roche’s Gazyva to treat chronic lymphocytic leukemia (CLL), another type of blood cancer, making it the first drug approved after receiving the breakthrough designation.

The FDA gives a breakthrough designation when it believes a medicine may offer a substantial improvement over existing therapies for serious or life-threatening diseases.

“The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in a statement.

Imbruvica is also awaiting an approval decision to treat CLL, which some analysts believed would come at the same time as the U.S. lymphoma approval.

“This is a relative short-time disappointment versus Wall Street expectations for simultaneous approval in both indications with a broad label,” RBC Capital Markets analyst Michael Yee said in a research note.

Yee, in an email, said RBC is forecasting long-term annual worldwide sales of $5 billion for Imbruvica.

Pharmacyclics shares were up $3.20, or 2.6 percent, at $122.87 on Nasdaq. Shares of Johnson & Johnson were down 85 cents, or 0.9 percent, at $92.71 on the New York Stock Exchange.

Source: Thomson Reuters foundation


Kuwait discovers first MERS virus case: ministry

Kuwait has discovered its first case of the MERS corona virus for a citizen who is in “critical condition,” the health ministry said on Wednesday.

“The first case of corona virus has been discovered in the country for a citizen who was moved to the Infectious Diseases Hospital in critical condition,” the ministry said, quoted by the official KUNA news agency.

The patient was a 47-year-old man who suffered from diabetes and high blood pressure, said the statement. It did not say how he might have been infected.

His infection makes Kuwait the fifth state in the Gulf to report cases of MERS, which has already killed 64 people worldwide, the majority of them in Saudi Arabia.

Two fatalities have been reported in Qatar and one in Oman.

The World Health Organization said on its website on Monday that it has been informed of 153 laboratory-confirmed MERS cases worldwide so far, including the 64 deaths.

Experts are struggling to understand the disease, for which there is no vaccine.

It is considered a deadlier but less-transmissible cousin of the SARS virus that erupted in Asia in 2003 and infected 8,273 people, nine percent of whom died.

Like SARS, MERS appears to cause a lung infection, with patients suffering from a temperature, coughing and breathing difficulties.

But it differs in that it also causes rapid kidney failure, and the extremely high death rate has caused serious concern.

In August, researchers pointed to Arabian camels as possible hosts of the virus.

And the Saudi government said on Monday that a camel in the kingdom has tested positive for MERS, the first case of an animal infected with the corona virus.

Source: Global post


Electronic cigarettes ‘could save millions of lives’

Scientists say that if all smokers in the world switched from cigarettes to electronic cigarettes, it could save millions of lives.

In the UK there are currently about 100,000 deaths per year attributable to smoking, worldwide it is estimated to be more than five million.

Now researchers are hopeful that an increasing use of e-cigarettes could prevent some of these deaths.

But some groups warn that e-cigarettes could normalise smoking.

An estimated 700,000 users smoke e-cigarettes in the UK, according to Action on Smoking and Health. Some users combine “vaping”, as it is often called, with traditional cigarettes while others substitute it for smoking completely.

E-cigarettes have also recently be found to be just as effective as nicotine patches in helping smokers quit.

Future hope

Rather than inhaling the toxic substances found in tobacco, e-cigarette users inhale vaporised liquid nicotine.

Robert West, professor of health psychology at University College London, told delegates at the 2013 E-Cigarette Summit at London’s Royal Society that “literally millions of lives” could be saved.

“The big question, and why we’re here, is whether that goal can be realised and how best to do it… and what kind of cultural, regulatory environment can be put in place to make sure that’s achieved.

“I think it can be achieved but that’s a hope, a promise, not a reality,” he said.

A revolution

This view was echoed by Dr Jacques Le Houezec, a private consultant who has been researching the effects of nicotine and tobacco.

He said that because the harmful effects of its main comparator, tobacco, e-cigarette use should not be over-regulated.

“We’ve been in the field for very long, this for us is a revolution

“Every adolescent tries something new, many try smoking. I would prefer they try e-cigarettes to regular cigarettes.” Dr Le Houezec added.

Many are now calling for the industry to be regulated. An EU proposal to regulate e-cigarettes as a medicine was recently rejected, but in the UK e-cigarettes will be licensed as a medicine from 2016.

Konstantinos Farsalinos, from the University Hospital Gathuisberg, Belgium, said it was important for light regulation to be put in place “as soon as possible”.

“Companies are all hiding behind the lack of regulation and are not performing any tests on their products, this is a big problem.”

Prof Farsalinos studies the health impacts of e-cigarette vapor. Despite the lack of regulation, he remained positive about the health risks associated with inhaling it.

Healthy rats

E-cigarettes are still relatively new, so there is little in the way of long-term studies looking at their overall health impacts.

In order to have valid clinical data, a large group of e-cigarette users would need to be followed for many years.

Seeing as many users aim to stop smoking, following a large group of e-smokers for a long period could be difficult.

But in rats at least, a study showed that after they inhaled nicotine for two years, there were no harmful effects. This was found in a 1996 study before e-cigarettes were on the market, a study Dr Le Houezec said was reassuring.

Concern about the increase in e-cigarette use remains.

The World Health Organization advised that consumers should not use e-cigarettes until they are deemed safe. They said the potential risks “remain undetermined” and that the contents of the vapor emissions had not been thoroughly studied

The British Medical Association has called for a ban on public vapingin the same way that public smoking was banned.

They stated that a strong regulatory framework was needed to “restrict their marketing, sale and promotion so that it is only targeted at smokers as a way of cutting down and quitting, and does not appeal to non-smokers, in particular children and young people”.

Ram Moorthy, from the British Medical Association, said that their use normalizes smoking behavior.

“We don’t want that behavior to be considered normal again and that e-cigarettes are used as an alternative for the areas that people cannot smoke,” he told BBC News.

But Lynne Dawkins, from the University of East London, said that while light-touch regulation was important, it must be treated with caution.

She said that e-cigarettes presented a “viable safer alternative” to offer to smokers.

“We don’t want to spoil this great opportunity we have for overseeing this unprecedented growth and evolving technology that has not been seen before, We have to be careful not to stump that.”

Source:  BBC news

 


Diabetes battle ‘being lost’ as cases hit record 382 million

The world is losing the battle against diabetes as the number of people estimated to be living with the disease soars to a new record of 382 million this year, medical experts said on Thursday.

The vast majority have type 2 diabetes – the kind linked to obesity and lack of exercise – and the epidemic is spreading as more people in the developing world adopt Western, urban lifestyles.

The latest estimate from the International Diabetes Federation is equivalent to a global prevalence rate of 8.4 percent of the adult population and compares to 371 million cases in 2012.

By 2035, the organization predicts the number of cases will have soared by 55 percent to 592 million.

“The battle to protect people from diabetes and its disabling, life-threatening complications is being lost,” the federation said in the sixth edition of its Diabetes Atlas, noting that deaths from the disease were now running at 5.1 million a year or one every six seconds.

People with diabetes have inadequate blood sugar control, which can lead to a range of dangerous complications, including damage to the eyes, kidneys and heart. If left untreated, it can result in premature death.

“Year after year, the figures seem to be getting worse,” said David Whiting, an epidemiologist and public health specialist at the federation. “All around the world we are seeing increasing numbers of people developing diabetes.”

He said that a strategy involving all parts of society was needed to improve diets and promote healthier lifestyles.

The federation calculates diabetes already accounts for annual healthcare spending of $548 billion and this is likely to rise to $627 billion by 2035.

Worryingly, an estimated 175 million of diabetes cases are as yet undiagnosed, so a huge number of people are progressing towards complications unawares. Most of them live in low- and middle-income countries with far less access to medical care than in the United States and Europe.

The country with the most diabetics overall is China, where the case load is expected to rise to 142.7 million in 2035 from 98.4 million at present.

But the highest prevalence rates are to be found in the Western Pacific, where more than a third of adults in Tokelau, Micronesia and the Marshall Islands are already living with the disease.

Pharmaceutical companies have developed a range of medicines over the years to counter diabetes but many patients still struggle to control their condition adequately, leading to a continuing hunt for improved treatments.

Novo Nordisk, Sanofi and Eli Lilly are all major suppliers of insulin and other diabetes therapies.

Source: Reuters

 


Weight-loss surgery yields lasting improvement in health

Fifteen years after they have weight-loss surgery, almost a third of patients who had Type 2 diabetes at the time they were operated on remain free of the metabolic disorder, a new study says. And six years following such surgery, patients had shaved their probability of suffering a heart attack over the next 10 years by 40%, their stroke risk by 42%, and their likelihood of dying over the next five years by 18%, additional research has concluded.

The two studies, both presented Wednesday in Atlanta at the Obesity Society’s annual meeting, offer the first indications of weight-loss surgery’s longer-term health benefits for patients. While researchers have demonstrated dramatic improvements in many bariatric patients’ metabolic function in the short term, the durability of those improvements has been unclear.

Research suggests that over several years, many bariatric patients regain some of the weight they lose in the first two years — a fact that has raised doubts about the cost-effectiveness of the surgery, which can cost $20,000 to $25,000 for the initial procedure, plus a wide range of costs to treat complications after surgery.

The new studies’ findings those patients’ health prospects remain better for several more years may make weight-loss surgery a more appealing treatment for insurers to cover, and for obese patients with health concerns to seek out.

The study that followed 604 bariatric patients in Sweden for 15 years found that in the first two years after surgery, 72% achieved diabetes remission: They were able to cease taking medication for the metabolic condition. After 15 years, a little more than half of those had diabetes again. But 31% had remained in remission.

By contrast, only 16% of the comparison group — similarly obese patients with diabetes who did not get surgery — had seen their diabetes remit in the first two years. At 15 years out, diabetes remission was six times likelier in those who had surgery than in the those who did not.

In another study, researchers at the Cleveland Clinic in Ohio followed bariatric patients for an average of six years after surgery. They tallied those patients’ likelihoods of developing a wide range of health outcomes at the time of surgery and six years later, and compared them. To do so, they used the Framingham risk calculator to estimate the before-and-after 10-year risks of heart disease, stroke, death, kidney disease and complications such as diabetic retinopathy and poor circulation.

(The Framingham risk calculator is derived from probabilities gleaned from following more than 10,000 subjects in Framingham, Mass., in the Framingham Heart Study, which started in 1948.)

In this study, the bariatric patients lost 60% of their excess weight and 61% saw their diabetes remit after surgery. Overall their risk of having coronary heart disease, stroke or peripheral heart disease dropped by 27%.

Bariatric surgeon Dr. John Morton, a professor of medicine at Stanford University who was not involved in either study, suggested that the results of more modern bariatric surgical procedures may be superior. He added that reducing the stress of obesity on the body, even if some weight returns, may improve a patient’s long-term health prospects.

“Carrying extra weight can carry forth year to year,” said Morton, who is president-elect of the American Society for Metabolic and Bariatric Surgery, which cosponsored the Obesity Society’s Atlanta conference. He likened long-term obesity to smoking cigarettes for years, suggesting that the number of years a person remains obese (or smokes) may interact with their degree of obesity (or how much they smoke) to influence his or her likelihood of developing health problems.

“Any removal of that extra weight and inflammation is a help,” Morton said.

Source: Los Angeles Times

 


Indian Specialist Hospital Reduces Prices for Patients

Efforts by the federal government to curtail capital flights from the country in form of medical tourism received a boost Wednesday, as the only Indian specialist hospital in Nigeria, Primus International Super Specialty Hospital announced a downward review of all its medical charges to 30 percent, including offer of free consultancy in the month of November.

According to the management of the hospital, the decision to crash the hospital fees is part of its Corporate Social Responsibility (CSR) to open its services and state of the art equipments to Nigerian patients, majority of whom could not afford to go abroad.

The move is seen as a strategic measure to halt foreign medical tourism by Nigerian patients who travel abroad for treatment, which is believed to cost the nation a whopping $300 million to $400 million in foreign exchange per annum.

The hospital’s Public Relations Officer, (PRO) Alhaji Umaru Jibia, in a statement made available to journalists in Abuja, said the hospital, in addition to providing free consultation to patients in the area of joint replacement, spine problem, internal medicine, diabetes, ENT, gynecology, neuro surgery, dental, ophthalmology and general surgery, was also reducing the cost of medical treatment to help low income earners in the country.

He added: “MRI charges will be from N50, 000 onwards, while CT scan will be from N25, 000 onwards. Radiology, laboratory services will cost 30 per cent less, while Pharmacy drugs will cost 20 per cent less. The surgical procedures are at very reasonable charges during the camp period.”

The reduction of hospital prices came at a time the government was working for a workable framework that would put a stop to the increasing cases of capital flights due to frequent medical overseas trips by Nigerians.

Since its establishment in Abuja, the hospital had been conducting free camps in the city and its environs, where 23,000 patients have benefited from free consultation and medical other services.

Source: This day Live


Philanthropist’s gift a big bang for stem cell research

A philanthropist who made his money as a credit card provider is giving $100 million to human stem-cell research.

The money will go to the University of California at San Diego during the next five years as researchers reach certain milestones, said T. Denny Sanford, who founded First Premier Bank here and offers low-limit Master cards and Visas to customers with poor credit through Premier Bankcard. United National Corp., where Sanford is now chief executive, owns both companies.

“This, in my opinion, is the medicine of the future,” he said. “The potential of stem cells is just unbelievable.”

The money will support the hiring of 20 or more scientists and efforts to recruit patients for drug trials along with new construction at the San Diego complex.

The donation pushes Sanford past the $1 billion mark for total gifts to health care and research, he said.

Sanford, 77, has homes in South Dakota, Arizona and California. On Oct. 19, he suffered a pulmonary embolism — a blood clot in the lungs — while on a hunting trip with friends near Gregory, S.D., about 140 miles west of here.

He said he was saved because of a middle-of-the-night medical flight to Sanford University of South Dakota Medical Center here, helicopter and plane flights made possible in part because of donations he has made to what is now Sanford Health system.

“I was within minutes or hours of death,” he said. His physician here, Dr. Eric Larson, said Sanford is doing fantastic, playing golf regularly and exercising on an elliptical machine, less than a month after getting clot-busting medications to treat the condition.

Most of Sanford’s donations, about $700 million, have gone to the Sanford Health. He has pledged to give all his money away. He said he still has close to $1 billion.

The $100 million he is committing to UC San Diego is the lead resource in a project that officials say will cost a total of $275 million.

What now is called the Sanford Consortium for Regenerative Medicine includes scientists from five institutions — UC San Diego, Sanford-Burnham, Scripps, the Salk Institute for Biological Studies and the LaJolla Institute for Allergy and Immunology.

“Overall, the effort is to bring stem cell research into human clinical trials,” said Debra Kain, director of health sciences research communications at UC San Diego.

In Sioux Falls, Sanford made a $400 million donation to the nonprofit medical center in 2007 and established four priorities, one of which was curing a major disease that officials later pegged as Type 1 diabetes. Another of his donations here, $100 million in 2011, is for research and treatment for breast cancer. His mother, Edith, died of the disease when he was 4 years old.

This gift is different because he has no personal or family connection to the neurological diseases he hopes that stem cell research can address.

Research so far has been instructive on the use of mice and monkeys, so it’s time now to extend the effort to humans, he said.

“We are excited about some major potential cures, particularly with neurological diseases like Lou Gehrig’s disease, or spinal cord injuries,” Sanford said. Lou Gehrig’s disease, also called amyotrophic lateral sclerosis, affects nerve cells in the brain and spinal cord that control muscle movement. It has no cure.

Sanford is excited that the work could lead several directions.

“It could be spinal cord injuries, Alzheimer’s, Parkinson’s, eventually heart and cancer and diabetes,” he said.

Source: USA Today

 


IBM opens global research lab in Africa IBM’s

12th global research lab was opened here last week. It is designed to conduct applied and far-reaching exploratory research into the big challenges of the African continent and deliver commercially viable innovations that impact people’s lives.

 The facility features one of Africa’s most powerful computer hubs, giving IBM researchers the ability to analyse and draw insight from vast amounts of data in search for solutions to Africa’s challenges such as energy, water, transportation, agriculture, healthcare, financial inclusion, human mobility and public safety.

“The establishment of this research laboratory underpins the government’s commitment to innovation ecosystems that are already available in Kenya,” said the president of Kenya, Uhuru Kenyatta. The lab is supported by the Kenyan ICT Authority.

The lab’s research agenda will include the development of cognitive computing technologies that integrate learning and reasoning capabilities, enabling experts to make better decisions in areas such as healthcare delivery and financial services.

“We are currently experiencing the emergence of a new Africa – one where science and technology are enabling a pivotal ‘leap frog’ moment allowing governments and businesses to drive economic growth, raise the standard of living and compete with their global counterparts,” said Kamal Bhattacharya, director, IBM Research-Africa.

“The launch of Africa’s first full-scale, technology research facility will help lay the foundation for the continent’s future scientific and economic independence,” he added. Nicholas Nesbitt, country general manager, East Africa, said it was not just about science and technology, “but also about innovating new business models and partnering with local enterprises to ensure that our new solutions have the maximum impact on business and society.”

Source: The Times of India

 


Biosensor to detect brain injuries during heart surgery

 

Scientists have developed a fingernail-sized biosensor that could alert doctors when serious brain injury occurs during heart surgery.

Johns Hopkins engineers and cardiology experts teamed up to develop the device and demonstrated in lab tests that the prototype sensor had successfully detected a protein associated with brain injuries.

“Ideally, the testing would happen while the surgery is going on, by placing just a drop of the patient’s blood on the sensor, which could activate a sound, light or numeric display if the protein is present,” said the study’s senior author, Howard E Katz, a Whiting School of Engineering expert in organic thin film transistors, which form the basis of the biosensor.

The project originated about two years ago when Katz, who chairs the Department of Materials Science and Engineering, was contacted by Allen D Everett, a Johns Hopkins Children’s Center pediatric cardiologist who studies biomarkers linked to pulmonary hypertension and brain injury.

Everett sought an engineer to design a biosensor that responds to glial fibrillary acidic protein (GFAP), which is a biomarker linked to brain injuries.

“If we can be alerted when the injury is occurring then we should be able to develop better therapies. We could improve our control of blood pressure or redesign our cardiopulmonary bypass machines,” Everett said.

“We could learn how to optimise cooling and rewarming procedures and have a benchmark for developing and testing new protective medications,” Everett added.

At present, Everett said, doctors have to wait years for some brain injury-related symptoms to appear. That slows down the process of finding out whether new procedures or treatments to reduce brain injuries are effective.

“The sensor platform is very rapid. It’s practically instantaneous,” Everett said.

To create this sensor, Katz turned to an organic thin film transistor design.

The sensing area is a small square, 3/8ths-of-an-inch on each side. On the surface of the sensor is a layer of antibodies that attract GFAP, the target protein.

When this occurs, it changes the physics of other material layers within the sensor, altering the amount of electrical current that is passing through the device.

These electrical changes can be monitored, enabling the user to know when GFAP is present.

“This sensor proved to be extremely sensitive. It recognised GFAP even when there were many other protein molecules nearby. As far as we’ve been able to determine, this is the most sensitive protein detector based on organic thin film transistors,” Katz said.

The study was published in the journal Chemical Science.

Source:  Zee News


Complex stent procedure performed on one-month-old baby

Complex stent procedure performed at Fortis Escort Heart Institute, New Delhi on a month old, 1.8 kg baby. (L-R) Dr S Radhakrishnan, director, paediatric and congenital heart diseases, FEHI and Dr Neeraj Awasthy, paediatric cardiologist, FEHI with the patient’s family.

Fortis Escorts Heart Institute (FEHI) has conducted a life-saving complex stent procedure on a one-month-old premature baby weighing 1.8 kg by a team of doctors comprising of Dr S Radhakrishnan, director, pediatric and congenital heart diseases and Dr Neeraj Awasthy, pediatric cardiologist. According to Fortis Escorts, this is the first case in India, with the lowest recorded weight and age of a baby undergoing a complex stent procedure. Her treatment has been funded by FEHI.

The baby was referred to FEHI by a government hospital in Delhi when she stopped breathing and showed signs of heart problems. The baby was immediately put on ventilator and was oxygen dependent for three weeks.

The artery going towards her lungs were found obstructive and this made her treatment complicated and high risk.

Explaining the complexity involved in the operation, Dr Radhakrishnan said, “Initially we kept the baby under ventilation for few days and when she started responding to our treatment, we decided to wean her off the ventilation. On further examination, it was found that the right ventricular outflow track was blocked and stent procedure should be performed. The baby would need a future surgery once she weighs 8-9 kg.”

Dr Awasthy said, “Given the multiple complexities of the case, her prognosis has been very good. When the case first came to us, her survival was a question. Such a case had never been attempted before anywhere in India. Today, after the surgeries, she is responding well to her treatment protocol.”

He added, “As the hospital is technologically equipped with advanced smaller size equipment to manage such complex cases, we were confident to go ahead and perform such a complex procedure which demanded additional vigilance and support.”

Source: India Medical Times