FDA Approves Nexavar for Advanced Thyroid Cancer

The US Food and Drug Administration (FDA) have approved Nexavar (sorafenib) to treat some people with advanced thyroid cancer. The drug was already on the market for treating some types of kidney cancer and liver cancer. The new approval is for treating differentiated thyroid cancer – the most common type – that has come back after treatment or that has spread to other parts of the body (metastasized), and is no longer responding to radioactive iodine treatment.

Thyroid cancer starts in the thyroid gland, which is located in the front part of the neck. Nexavar is a targeted therapy that can help stop the growth of cancer cells by interfering with signals that encourage them to grow. Nexavar qualified for faster review under the FDA’s priority review program for drugs that may offer a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The drug also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases.”

The FDA based its approval on a clinical study involving 417 people with advanced, differentiated thyroid cancer that was not responding to radioactive iodine treatment. Nexavar increased the length of time patients lived without the cancer growing by 41%. Half the people who received Nexavar lived without the cancer growing for at least 10.8 months compared to at least 5.8 months for those who received a placebo.

The most common side effects for Nexavar were diarrhea, fatigue, infection, hair loss, skin problems on the hands and feet, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, and high blood pressure. Thyroid stimulating hormone is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone therapy.

Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals.


HIV infections up in Europe and Central Asia

Sweden – HIV infections in Europe and Central Asia increased by eight percent in 2012 compared to a year earlier, the European Centre for Disease Prevention and Control announced on Wednesday, November 27.

The rise of 131,000 new cases was driven by a nine-percent increase in the Eastern Europe and Central Asia region which accounted for 102,000 new infections — around three-quarters of them in the Russian Federation alone.

In the European Union and Iceland, Liechtenstein and Norway, new infections rose by less than one percent to 29,000, according to the joint report by the EU agency and the World Health Organisation (WHO).

Almost half of the new cases were detected at an advanced stage of the infection which raises the risk of transmission to others.

Among the reasons for the increase is the lack of awareness of anti-retroviral treatments.

“We know that providing antiretroviral therapy earlier will allow people with HIV to live longer and healthier lives, and will reduce the risk that they transmit HIV to others,” WHO regional director for Europe, Zsuzsanna Jakab said.

AIDS cases were down by 48 percent in Western Europe between 2006 and 2012, while in Eastern Europe and Central Asia, the number of newly diagnosed cases of the disease caused by HIV increased by 113 percent.

According to the report, only one in three people in need of anti-retroviral therapy was receiving in last year, despite improved figures compared to 2011.

In 2011 there were 2,300,000 people living with HIV in Europe and Central Asia, according to the WHO.

Source: Rappler


1 mn deaf children in India awaiting medical aid: Natarajan

Noting that about one million deaf children in the country are in need of modern medical treatment like cochlear implantation, Union Environment Minister Jayanthi Natarajan today said a holistic effort by government, medical fraternity and others would help in propagating the technology for the benefit of such kids.

“Even though more than 20,000 cochlear implantations have thus been done across India, we still face an uphill task with potentially one million children awaiting implantation, for many of whom cost of implant is a deterrent,” Natarajan said.

She said this fact has come to light from the Central government’s deafness survey titled “The National Program for the Prevention and Control of Deafness”. The minister was speaking after inaugurating the 9th Asia Pacific Symposium on Cochlear Implants and Related Sciences (APSCI 2013) here.

“States like Tamil Nadu, Andhra Pradesh and Kerala have taken the initiative for totally funding cochlear implants through their ‘Chief Minister’s Comprehensive Health Insurance Schemes’, which has motivated other states to follow up in the same way,” Natarajan informed.

She observed that a holistic effort by government, in collaboration with medical fraternity and society, can make a “remarkable transition in the lives of the deaf children in bringing them out of the gloomy world of silence, onto the vibrant world of sound.”

“Such an effort can be fulfilled only when technology is propagated to all rural areas across the country and the success of such an effort would lead to realising a deafness free India in the near future,” Natarajan said.

The minister said the science of deafness was undergoing rapid changes in recent times. “…There is a need for updating the recent advances among the medical and allied fraternity (otolaryngologists, audiological scientists etc) and the symposium is a step in that direction,” she said.

The APSCI 2013 is being attended by over 1,000 delegates from around 60 countries across the globe.

Source: Business Standard


Tongue controller for the paralyzed offers greater independence

In an advance that promises to improve the lives of the more than 250,000 people in the United States who are paralyzed from the neck down, researchers announced on Wednesday that they have developed a wireless device that operates specially rigged chairs by means of a tiny titanium barbell pierced through the tongue.

Merely by moving their tongues left or right across their mouths, essentially using it as a joystick, paralyzed patients have been able to move their motorized wheelchairs, as well as computer cursors. Tapping tongue against cheek, quickly or slowly, controls the chair’s speed.

The advance “is more than just a wheelchair control,” said Jason Disanto, 39, who has been paralyzed from the neck down since a 2009 diving accident and tested the device. “It’s an independence system.”

The innovation is especially meaningful for the most seriously paralyzed. Tetraplegics cannot use a joystick to operate their wheelchairs, as people with less severe paralysis can, and in many cases cannot even use voice commands: their voices are often so weak that recognition systems work poorly or not at all.

Even more advanced assistive technologies fall short. Brain-computer interfaces (BCIs), which translate brain waves from the scalp into electrical signals that move a motorized wheelchair or computer cursor, require intense concentration, have slow response times and are vulnerable to electronic interference. The implantable versions are more reliable but can damage brain tissue.

The most popular technology for operating a motorized wheelchair, called sip-and-puff devices and based on inhaling or exhaling into a tube, offers only four commands – forward, back, left and right—and is also slow and cumbersome.

Way faster, way more agency

Engineer Maysam Ghovanloo of the Georgia Institute of Technology in Atlanta thought he could do better. About five years ago he and his colleagues began developing the tongue-based system. An early version used magnets glued to the tongue, but they fell off. Dr Anne Laumann of the Feinberg School of Medicine at Northwestern University, a co-author of the new paper, had an idea: use piercing to anchor the magnets in place.

The device they came up with is a small magnetic barbell, which creates a magnetic field in the mouth. When users flick their tongues, it alters that field. The change is picked up by four small sensors on a headset with twin extensions curving around the cheeks, and relayed wirelessly to a smart phone, computer or iPod. The software translates the signals and sends them to a powered wheelchair or computer.

For the new study, published in Science Translational Medicine, Ghovanloo and his team tested the tongue system on 11 tetraplegia patients from rehabilitation centers in Chicago and Atlanta and 23 able-bodied volunteers who already wore tongue jewelry.

After just 30 minutes of training, everyone was able to move a computer cursor, clicking on targets on a laptop screen, playing video games and dialing phone numbers. Accuracy and speed improved with practice, even though subjects used the system only one day a week. After six weeks the tetraplegics were, on average, three times faster with the tongue system than with sip-and-puff, which six of the 11 (including Disanto) had been using. It was equally accurate.

Using only tongue movements, the volunteers also navigated a powered wheelchair through a 50-meter-long course with 13 turns, 24 obstacles and occasional alarms signaling “Stop! Emergency!” Here, too, on average the 11 tetraplegics drove the course three times faster with the tongue system than with sip-and-puff, and just as accurately.

“The learning was very, very fast,” Ghovanloo said. “There was a huge improvement in performance from the first session to the second.”

To Disanto, an electrical engineer, the appeal of the system is aesthetic as well as functional.

“With all the equipment that’s in my face” with the sip-and-puff system, “people saw that and not me,” he said.

The tongue system is a vast improvement, but he encouraged the researchers to go even further, and they have: they are developing a version that dispenses with the headset and instead fits inside the mouth, like a retainer.

The tongue system’s ability to operate numerous devices also promises more agency, Disanto said. He currently uses a voice-recognition system and a “head mouse” (an optical sensor that translates head movements into cursor movements) to use his computer, “but this is going to allow people like me to use one system instead of multiple ones,” he said. “I’ll be able to drive my wheelchair and connect to my computer seamlessly, and eventually connect to home devices, using it to work lights, curtains, TV and heat. I’ll be more independent.”

Those home systems already exist, with many smartphones offering apps that control home appliances, lights and heating-and-cooling systems.

“This is another example of how the field of rehab engineering and assistive devices is continuously evolving and benefiting from incorporating the emerging new technologies,” said Dr Daofen Chen, program director at the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.

The researchers plan to test the tongue system “using Atlanta as our laboratory,” said Joy Bruce, manager of spinal cord injury at the Shepherd Center, a rehab center in Atlanta where the study was conducted. “We’ll see if patients can use it to navigate in the community – taking the bus, going to work and doing other things they haven’t been able to.”

Ghovanloo’s startup company, Bionic Sciences, is working with Georgia Tech to commercialize the barbell device. The $1 million he got from the 2009 economic stimulus bill is gone, and government science funding has plummeted, so Georgia Tech is setting up a website and planning to use social media to raise money. If Ghovanloo gets the funds, he hopes to test the system in the streets of Atlanta next year

Source: GMA News


Modafinil could help fight depression

A new study has concluded that taking the drug modafinil, typically used to treat sleep disorders, in combination with antidepressants reduces the severity of depression more effectively than taking antidepressants alone.

The study, a collaboration between King’s College London and the Universities of Cambridge and East London, was published online in the Journal of Clinical Psychiatry.

Approximately a third of depressed patients receive little or no benefit from taking antidepressants even when used in combination with psychological counselling. Furthermore, of those who respond to treatment, residual symptoms such as fatigue and trouble sleeping pose risk factors for relapse. The authors of the study believe that these individuals in particular would benefit the most from supplementing their antidepressants with modafinil.

Professor Barbara Sahakian from the University of Cambridge said, “Modafinil has actions on a number of neurotransmitter systems. This may explain why adding it to traditional anti-depressants, such as selective serotonin re-uptake inhibitors,has beneficial effects on the symptoms experienced by depressed patients.”

“This is good news for individuals struggling to fight depression,” said Professor Cynthia Fu who undertook the research whilst at King’s College London’s Institute of Psychiatry, and currently at the University of East London, . “Depression affects all aspects of life, leading to occupational and social disability at varying levels. It is particularly important that people receive effective treatment as the residual symptoms – e.g. fatigue, lack of concentration etc. -can persist and have a negative impact in people’s lives.”

For the research, the scientists reviewed various studies which had examined the use of modafinil as an add-on treatment for depression. The meta-analysis involved a total of 568 patients with unipolar depression and a total of 342 patients with bipolar depression. The analysis revealed that modafinil improved the severity of depression as well as remission rates. Modafinil also showed beneficial effects on fatigue and sleepiness, with the added benefit of the comparable side effects to placebo.

The research also revealed that the symptomatic benefits of modafinil might also have implications for improving the difficulty of functioning at work sometimes caused by depression. This is significant because depression is a major cause of absenteeism (absence due to sick leave) and presenteeism (present at work but not functioning as before).

Dr Muzaffer Kaser from the University of Cambridge added: “The next step is for longer trials to evaluate potential benefits of supplementing antidepressants with modafinil more comprehensively.”

Depression is a major global health problem. According to the World Health Organisation, it is estimated to be the second leading cause of disability worldwide by 2020.Recent studies revealed that depression represents more than a third of global burden of disease attributable to mental health problems*. The annual cost of mood disorders to the UK economy is estimated to be around £16 billion**.Disability caused by depression is mainly due to the negative impact on work and social functioning and its relapsing nature.

The paper ‘Modafinil Augmentation Therapy in Unipolar and Bipolar Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials’ is published in the November edition of Journal of Clinical Psychiatry. 

Source: Kings College London


Five health benefits of apples

You may have heard the saying “An apple a day keeps the doctor away” many times, but do you know the reasons why?

1. Apples are good source of soluble fiber which helps to ease intestinal disorders and control insulin levels.

2. Flavanols and procyanidins in apples may work in the body to exert cardiovascular benefits, suggests study.

3. Apples have low calorie content, around 50-80 calories per apple, and has no fat or sodium.

4. Apples are packed with B-complex vitamins (riboflavin, thiamin, and vitamin B-6) which help in maintaining red blood cells and the nervous system.

5. Phytonutrients in apples help protect the body from the harmful effects of free radicals.

Source: Zee News


New HIV strain leads to faster AIDS development

A NEW and more aggressive strain of HIV discovered in West Africa causes significantly faster progression to AIDS, according to Swedish researchers.

The new strain of the virus that causes AIDS, called A3/02, is a fusion of the two most common HIV strains in Guinea-Bissau. It has so far only been found in West Africa.

“Individuals who are infected with the new recombinant form develop AIDS within five years, and that’s about two to two-and-a-half years faster than one of the parent (strains),” said Angelica Palm, one of the Lund University scientists responsible for the study based on a long-term follow-up of HIV-positive people in Guinea-Bissau.

Recombinant virus strains originate when a person is infected by two different strains, whose DNA fuse to create a new form.

“There have been some studies that indicate that whenever there is a so-called recombinant, it seems to be more competent or aggressive than the parental strains,” said Palm of the study published in the Journal of Infectious Diseases.

The strain was first discovered by the Swedish team in Guinea-Bissau in 2011.

According to researchers, the speed with which A3/02 leads to people falling ill from AIDS does not impact on the effectiveness of medication on infected individuals.

“The good news is that as far as we know the medicines that are available today are equally functional on all different subtypes of variants,” Palm said.

The study warns that such recombinants may be spreading fast, especially in regions with high levels of immigration, such as Europe or the United States.

“It is highly likely that there are a large number of circulating recombinants of which we know little or nothing,” said Patrik Medstrand, professor of clinical virology at Lund University.

Some 35.3 million people around the world are living with HIV, which destroys the immune system and has caused more than 25 million deaths since AIDS first emerged in the early 1980s, according to the World Health Organisation.

Existing treatments help infected people live longer, healthier lives by delaying and subduing symptoms, but do not cure AIDS. Many people in poor communities do not have access to the life-giving drugs, and there is no vaccine.

Source: news.com


New treatment ‘could help spine injury patients walk’

Scientists say they have discovered that breathing low oxygen levels in short bursts could help improve the mobility of people with spinal cord injuries. This is according to a study published in the journal Neurology.

Spinal cord injury (SCI) is defined as disruption to the nerves attached to the spinal cord in the back. When the nerves are damaged, this can lead to reduced feeling in the body and loss of mobility, such as the inability to walk.

According to the National Spinal Cord Injury Statistical Center (NSCISC), there are approximately 12,000 new cases of spinal cord injury in the US every year.

Randy D. Trumbower, of Emory University in Atlanta, GA, and a study author of this most recent research, says that around 59% of all spinal injuries are incomplete. This means damage to the spinal cord is not absolute, so there is potential for the spinal cord to recover.

“Unfortunately, usually a person affected by this type of spinal injury seldom recovers the ability to walk normally,” Trumbower adds.

But the investigators believe their new research may give promise to those who have lost mobility as a result of spinal cord injuries.

Patients exposed to hypoxia treatment

To reach their findings, the investigators analyzed 19 individuals who suffered spine injuries between levels C2 (in the neck) and T12 (in the thoracic vertebrae) of the spine.

Participants had no joint shortening, some controlled ankle, knee and hip movements, and they had the ability to walk a minimum of one step without human help.

The subjects were split into two groups. In the first group, nine people were exposed to either hypoxia – short periods of breathing low oxygen levels – or a sham treatment (control treatment) in which they received only normal oxygen levels. After 2 weeks, they received the other treatment.

The hypoxia treatment involved subjects breathing low oxygen levels through a mask for 90 seconds, followed by 60 seconds of normal oxygen levels, and they were required to do this for 40 minutes a day for 5 days.

The second group received either the hypoxia or sham treatment, then they were asked to walk as fast as they could for 30 minutes within 1 hour of the treatment. They were also switched to the other treatment 2 weeks later.

The researchers monitored the participants’ walking speed and endurance before the study began, on the first and fifth days of treatment, and 1 and 2 weeks after treatment ceased.

Endurance ‘increased by 250%’

The findings revealed that on a 10-meter walking test, participants who received the hypoxia treatment walked an average of 3.8 seconds faster, compared with when they breathed only normal oxygen levels.

On a test of how far subjects could walk in 6 minutes, those who received the hypoxia treatment plus walking increased their endurance by an average of 100 meters – a 250% increase, compared with those who received sham treatment plus walking.

Overall, it was found that all participants showed improved walking ability. In detail, over 30% increased their walking speed by a minimum of 1/10 of a meter per second, and 70% increased their endurance by at least 50 meters.

In an editorial linked to the study, Michael G. Fehlings, of the University of Toronto in Canada, hypothesizes how the hypoxia treatment may work:

“One question this research brings to light is how a treatment that requires people to take in low levels of oxygen can help movement, let alone in those with compromised lung function and motor abilities.

A possible answer is that spinal serotonin, a neuro transmitter, sets off a cascade of changes in proteins that help restore connections in the spine.”

The investigators warn that chronic or sustained hypoxia should only be carried out by trained individuals within a supervised medical environment, or it could cause serious injury

Source: Medical News today

 

 


Fruit flies may harbor dementia cure

Researchers have taken a significant step forward in unraveling the mechanisms of Pavlovian conditioning and understanding this will help understand how memories form and, ultimately, provide better treatments to improve memory in all ages.

“Memory is essential to our daily function and is also central to our sense of self. To a large degree, we are the sum of our experiences. When memories can no longer be retrieved or we have difficulty in forming new memories, the effects are frequently tragic. In the future, our work will enable us to have a better understanding of how human memories form,” Gregg Roman, an associate professor of biology and biochemistry at University of Houston’s said.

Roman along with his team studied the brains of fruit flies (Drosophila). Within the fly brain, Roman said, there are nerve cells that play a role in olfactory learning and memory.

Roman said they found that these particular nerve cells- the gamma lobe neurons of the mushroom bodies in the insect brain- are activated by odours. Training the flies to associate an odour with an electric shock changed how these cells responded to odours by developing a modification in gamma lobe neuron activity, known as a memory trace.

They found that training caused the gamma lobe neurons to be more weakly activated by odours that were not paired with an electric shock, while the odours paired with electric shock maintained a strong activation of these neurons. Thus, the gamma lobe neurons responded more strongly to the trained odour than to the untrained odour.

The team also showed that a specific protein – the heterotrimeric G(o) protein – is naturally involved in inhibiting gamma lobe neurons.

Roman said removing the activity of this protein only within the gamma lobe neurons resulted in a loss of the memory trace and, thus, poor learning. Therefore, inhibiting the release of neurotransmitters from these neurons through the actions of the G(o) protein is key to forming the memory trace and associative memories.

The significance of using fruit flies is that while their brain structure is much simpler with far fewer neurons, the mushroom body is analogous to the perirhinal cortex in humans, which serves the same function of sensory integration and learning.

The study was published in journal Current Biology.

Times of India


Obesity Linked With Hearing Loss

Obesity is associated with a higher risk for hearing loss, according to a new study in the American Journal of Medicine.

 On the other hand, greater levels of physical activity are associated with a lower risk for hearing loss, found researchers from Brigham and Women’s Hospital.

“We often think of hearing loss as an inevitable part of the aging process, but these findings provide evidence that potentially modifiable risk factors, such as maintaining a healthy weight and staying physically active, may help in the prevention of hearing loss or delay its progression,” study researcher Sharon Curhan, M.D., Sc.M., of the Channing Division of Network Medicine at Brigham and Women’s Hospital, said in a statement.

More than 68,000 women who were part of the Nurses’ Health Study II were included in the study; their physical activity, body mass index, waist circumference and hearing loss were tracked from 1989 and 2009.

Researchers found associations between higher body mass index and waist circumference and hearing loss. Specifically, women who had a body mass index of 30 to 34 (indicative of obesity) had a 17 percent higher risk of hearing loss, compared with women who had a BMI lower than 25 (normal weight is indicated by a BMI of 18.5 to 24.9, while overweight is indicated by a BMI of 25 to 29.9). And people with a BMI of 40 or greater had a 25 percent higher risk of hearing loss.

Women with a waist circumference of 80 to 88 centimeters had an 11 percent higher risk of hearing loss compared with women with a waist circumference less than 71 centimeters. And women with a waist circumference greater than 88 centimeters had a 27 percent higher risk of hearing loss.

Meanwhile, exercise seemed to decrease risk for hearing loss. Women who were the most physically active in the study had a 17 percent lower risk of hearing loss than women who were the least physically active. And it didn’t even have to be especially strenuous activity: Researchers found that walking just two hours or more a week lowered hearing loss risk 15 percent more than walking less than an hour a week.

While the study only showed an association between hearing loss and obesity, this isn’t the first time the two have been linked. A study published earlier this year in the journal The Laryngoscope showed that obese teens have a nearly doubled risk of one-sided low-frequency hearing loss, compared to their peers of normal weight. The researchers of that study speculated that a potential reason for this association is inflammation from obesity; other potential reasons include Type 2 diabetes or heart disease from obesity, which could then lead to hearing loss.

Source: Huffington post