quinta-feira, 12 de junho de 2014

Charging portable electronics in 10 minutes: New architecture for lithium-ion battery anodes far outperform the current standard

 


Mihri and Cengiz Ozkan, both professors in the Bourns College of Engineering.

Researchers have developed a three-dimensional, silicon-decorated, cone-shaped carbon-nanotube cluster architecture for lithium ion battery anodes that could enable charging of portable electronics in 10 minutes, instead of hours.

Lithium ion batteries are the rechargeable battery of choice for portable electronic devices and electric vehicles. But, they present problems. Batteries in electric vehicles are responsible for a significant portion of the vehicle mass. And the size of batteries in portable electronics limits the trend of down-sizing.

Silicon is a type of anode material that is receiving a lot of attention because its total charge capacity is 10 times higher than commercial graphite based lithium ion battery anodes. Consider a packaged battery full-cell. Replacing the commonly used graphite anode with silicon anodes will potentially result in a 63 percent increase of total cell capacity and a battery that is 40 percent lighter and smaller.

In a paper, Silicon Decorated Cone Shaped Carbon Nanotube Clusters for Lithium Ion Battery Anode,recently published in the journal SMALL, UC Riverside researchers developed a novel structure of three-dimensional silicon decorated cone-shaped carbon nanotube clusters architecture via chemical vapor deposition and inductively coupled plasma treatment.

Lithium ion batteries based on this novel architecture demonstrate a high reversible capacity and excellent cycling stability. The architecture demonstrates excellent electrochemical stability and irreversibility even at high charge and discharge rates, nearly 16 times faster than conventionally used graphite based anodes.

The researchers believe the ultrafast rate of charge and discharge can be attributed to two reasons, said Wei Wang, lead author of the paper.

One, the seamless connection between graphene covered copper foil and carbon nanotubes enhances the active material-current collector contact integrity which facilitates charge and thermal transfer in the electrode system.

Two, the cone-shaped architecture offers small interpenetrating channels for faster electrolyte access into the electrode which may enhance the rate performance.

Wang is a graduate student advised by Cengiz S. Ozkan, a mechanical engineering professor at UC Riverside's Bourns College of Engineering; and Mihrimah Ozkan, an electrical engineering professor. Both of them are co-authors of the paper.

Other co-authors are Isaac Ruiz, Kazi Ahmed, Hamed Bay, Aaron George, who are all graduate students, and Johnny Wang, an undergraduate student.

A fuel cell for home: Tested in private households

 


Production of the cell stacks at the Fraunhofer IKTS.

It converts chemical energy directly into electrical energy. Still, there hadn't been a market breakthrough for the fuel cell. The systems were too complex. Now, Fraunhofer and Vaillant have developed a simple device for home use.

"One always speaks of a fuel cell system," says Dr. Matthias Jahn from the Fraunhofer Institute for Ceramic Technologies and Systems IKTS in Dresden. A single cell doesn't produce enough voltage to obtain a sufficient electrical power. In a fuel cell stack, several cells are connected one to the other. Each of them is about the size of a CD. We call the groups ‚stacks'," says Jahn. Fuel cells convert natural gas directly into electrical energy. They are many times more efficient than are combustion engines, such as the car engine. These require an intermediate step. First, they convert chemical energy into thermal energy (heat) and mechanical energy (force). With this force, they drive a generator, which only then generates the electric power. In the process, a large portion of the originally available energy is lost.

Real-life test in private households

Together with the heater manufacturer Vaillant, the IKTS has developed a compact, safe and sturdy fuel cell system that generates electricity and heat in private households from natural gas. The researchers were particularly responsible for the construction of the prototype, the design of the overall system, the design of the ceramic components and the development of the reformer and the afterburner. The devices are currently being tested in private households in the Callux practice test.

They are as compact as classical gas heaters that only produce heat. Moreover, they can comfortably be mounted on the wall and easily be maintained. With an output of one kilowatt, they cover the average current consumption for a four-person household. The Federal Ministry of Transport and digital infrastructure BMVI is promoting Callux. Currently, in the European demonstration project ene.field, about 150 further units are being installed in several European countries. In addition, Vaillant started the production of a small-scale series in early 2014. Parallel to the practical test, the two partners are already working on new models. "Now, it's all about decreasing production costs and increasing the lifetime of the equipment," says Jahn.

The principle of the fuel cell has been known for over 175 years. So far, however, there has not been a market breakthrough. The main reason was the invention of the electric generator. It knocked the more complex fuel cell out of the running. Only in the 1960s was the technology put into practice by NASA in some Apollo moon missions. In the late 1990s, there were other projects in the automotive industry, which have so far not been able to prevail. The reasons are that the fuel cell is too complex, too expensive, and too unreliable. "In our project with Vaillant, we have made great strides to bring the technology close to the market. Vaillant is already producing a small-scale series, which is sold in funded projects to customers," says Jahn. "For the market breakthrough, the costs still have to be decreased significantly."

The miniature power station for home use is based on a solid fuel cell (SOFC). SOFCs operate at a much higher temperature in comparison to competing approaches, such as the proton exchange membrane fuel cell (PEMFC), which is used in cars, for example. While PEMFCs only reach 80 degrees, SOFCs can reach up to 850 degrees. "This allows the SOFCs to be built much more simply and cheaply," says Jahn.

The electrolyte of an SOFC only transfers oxygen ions, not electrons. Otherwise, there would be a short circuit. "Ceramic is particularly well suited as a material for the electrolyte. It has the desired conductivity and can also endure high temperatures," says Jahn. As a result, even without the use of precious metals, all reactions proceed smoothly, which is necessary for the direct conversion of chemical energy into electrical energy: If the fuel cell heater is connected to the gas network, a reformer initially converts the natural gas into a hydrogen-rich gas. This then reacts in the stack with the oxygen of the air in a noiseless "cold combustion," producing power and heat.


Story Source:

The above story is based on materials provided by Fraunhofer-Gesellschaft. Note: Materials may be edited for content and length.

Chemical sensor on a chip created to test chemical composition of liquids

 


Just a drop is enough to test the chemical composition.

Using miniaturized laser technology, a tiny sensor has been built at the Vienna University of Technology which can test the chemical composition of liquids.

They are invisible, but perfectly suited for analyzing liquids and gases; infrared laser beams are absorbed differently by different molecules. This effect can for instance be used to measure the oxygen concentration in blood. At the Vienna University of Technology, this technique has now been miniaturized and implemented in the prototype for a new kind of sensor.

Specially designed quantum cascade lasers and light detectors are created by the same production process. The gap between laser and detector is only 50 micrometres. It is bridged by a plasmonic waveguide made of gold and silicon nitride. This new approach allows for the simple and cheap production of tiny sensors for many different applications.

Laser and Detector Simple solid-state lasers, such as the well-known red ruby laser, consist of only one material. Quantum cascade lasers, on the other hand, are made of a perfectly optimized layer system of different materials. That way, the properties such as the wavelength of the laser can be tuned. When a voltage is applied to the layer structure, the laser starts to emit light. But the structure can also work the other way around; when it is irradiated with light, an electric signal is created.

Now a method has been developed to create a laser and a detector at the same time, on one single chip, in such a way that the wavelength of the laser perfectly matches the wavelength to which the detector is sensitive. This bifunctional material was created atomic layer for atomic layer at the center for micro- and nanostructures at the Vienna University of Technology. "As both parts are created in one step, laser and detector do not have to be adjusted. They are already perfectly aligned," says Benedikt Schwarz.

Leading the Light to the Detector

In conventional systems, the laser light has to be transmitted to the detector using carefully placed lenses. Alternatively, optical fibres can be used, but they usually transport all the light inside, without letting it interact with the environment, and therefore they cannot be used as sensors.

In the new element created at the Vienna University of Technology, the optical connection between quantum cascade laser and detector works in a completely different way. It is a plasmonic waveguide, made of gold and silicon oxide. "The light interacts with the electrons in the metal in a very special way, so that the light is guided outside the gold surface," says Benedikt Schwarz. "That is why the light can be absorbed by the molecules on its way between laser and detector."

The sensor chip can be submerged in a liquid. By measuring the decrease of the detected light intensity due to the presence of light absorbing molecules, the composition of the liquid can be determined. The sensor was tested with a mixture of water and alcohol. The water concentration can be measured with an accuracy of 0.06%.

As the wavelength can be influenced by changing the design of the layered structure, this sensor concept can be applied to a wide variety of molecules such as carbohydrates or proteins, for many different applications in chemical, biological or medical analytics.


Story Source:

The above story is based on materials provided by Vienna University of Technology. The original article was written by Florian Aigner. Note: Materials may be edited for content and length.


Humans climb like geckos using bio-inspired climbing technology

 

June 11, 2014

DARPA's Z-Man program has demonstrated the first known human climbing of a glass wall using climbing devices inspired by geckos. The historic ascent involved a 218-pound climber ascending and descending 25 feet of glass, while also carrying an additional 50-pound load in one trial, with no climbing equipment other than a pair of hand-held, gecko-inspired paddles. A novel polymer microstructure technology was used in those paddles.


During testing, an operator climbed 25 feet vertically on a glass surface using no climbing equipment other than a pair of hand-held, gecko-inspired paddles. The climber wore, but did not require, the use of a safety belay.

DARPA's Z-Man program has demonstrated the first known human climbing of a glass wall using climbing devices inspired by geckos. The historic ascent involved a 218-pound climber ascending and descending 25 feet of glass, while also carrying an additional 50-pound load in one trial, with no climbing equipment other than a pair of hand-held, gecko-inspired paddles. A novel polymer microstructure technology was used in those paddles.

Historically, gaining the high ground has always been an operational advantage for warfighters, but the climbing instruments on which they're frequently forced to rely -- tools such as ropes and ladders -- have not advanced significantly for millennia. Not only can the use of such tools be overt and labor intensive, they also only allow for sequential climbing whereby the first climber often takes on the highest risk.

DARPA created the Z-Man program to overcome these limitations and deliver maximum safety and flexibility for maneuver and rapid response to warfighters operating in tight urban environments. The goal of the program is to develop biologically inspired climbing aids to enable warfighters carrying a full combat load to scale vertical walls constructed from typical building materials

Geckos can climb on a wide variety of surfaces, including smooth surfaces like glass, with adhesive pressures of 15-30 pounds per square inch for each limb, meaning that a gecko can hang its entire body by one toe. The anatomy of a gecko toe consists of a microscopic hierarchical structure composed of stalk-like setae (100 microns in length, 2 microns in radius). From individual setae, a bundle of hundreds of terminal tips called spatulae (approximately 200 nanometers in diameter at their widest) branch out and contact the climbing surface.

A gecko is able to climb on glass by using physical bond interactions -- specifically van der Waals intermolecular forces -- between the spatulae and a surface to adhere reversibly, resulting in easy attachment and removal of the gecko's toes from the surface. The van der Waals mechanism implied that it is the size and shape of the spatulae tips that affect adhesive performance, not specific surface chemistry. This suggested that there were design principles and physical models derived from nature that might enable scientists to fabricate an adhesive inspired by gecko toes.

Humans, of course, have much more weight to carry than a gecko. One of the initial challenges in developing a device to support human climbing was the issue of scaling: a typical Tokay gecko weighs 200 grams, while an average human male weighs 75 kilograms. To enable dynamic climbing like a gecko at this larger scale required that the engineers create climbing paddles capable of balancing sufficient adhesive forces in both the shear (parallel to the vertical surface) and normal (perpendicular to the vertical surface) directions. That feature is necessary for a climber to remain adhered on a surface without falling off while in the act of attaching and detaching the paddles with each movement.

The Draper Laboratory team was also challenged to create novel micro- and nanofabrication technologies to produce the high-aspect-ratio microstructures found in the gecko toe. In the process of achieving that capability, the Z-Man performers transformed the fundamental design and development of reversible adhesives for potential biomedical, industrial, and consumer applications.

The first human climbing demonstration occurred in February 2012 and tests of the technology are ongoing.


Story Source:

The above story is based on materials provided by DARPA. Note: Materials may be edited for content and length.

Dangerous, underpaid work for the undocumented

 

June 10, 2014

Cornell University

Illegal immigrants don't hold the most dangerous jobs in the United States. That kind of work pays a decent wage for the risk to life and limb, and undocumented workers are barred from those jobs. Yet there is plenty of hazard, risk and occupational injury for the uncounted millions of illegal immigrants doing the 'merely dangerous' work no one else wants -- without a pay premium from employers who take advantage of that labor pool, a study reveals.


Yet there is plenty of hazard, risk and occupational injury for the uncounted millions of illegal immigrants doing the "merely dangerous" work no one else wants -- without a pay premium from employers who take advantage of that labor pool, a Cornell-Penn State University study reveals.

"Undocumented Mexicans receive effectively no wage premium for working in dangerous settings, whereas most other groups (including legal Mexican immigrants, and native whites, blacks and Hispanics) do," says Matthew Hall, assistant professor of policy analysis and management in Cornell's College of Human Ecology.

With Penn State's Emily Greenman, Hall published "The Occupational Cost of Being Illegal in the United States: Legal Status, Job Hazards and Compensating Differentials" this month online in the journal International Migration Review.

They report: "Undocumented workers are rewarded less for employment in hazardous settings, receiving low or no compensating differential for working in jobs with high fatality, toxic materials or exposure to heights ... legal status plays an important role in determining exposure to job hazard and in structuring the wage returns to risky work."

The researchers' study focused on undocumented immigrants from Mexico and Central American countries and noted that the majority of Hispanic undocumented workers in the United States today are Mexican.

The social scientists discount popular claims that undocumented workers are engaged in the very most dangerous occupations -- logging or mining, to name jobs with the most fatalities according to the Bureau of Labor Statistics. Regulatory oversight of extremely hazardous workplaces keeps undocumented workers away from risky-but-remunerative jobs -- shuffling them to the margins, where danger also lurks. Agricultural workers can be maimed in farm equipment; day-labor construction workers fall from heights every day, they report.

Data analyzed by the social scientists come from the U.S. Census' Survey of Income and Program Participation, which includes information on citizenship and visa status; the Department of Labor's Occupational Information Network; and the Bureau of Labor Statistics' Census of Fatal Occupational Injuries.

Hall and Greenman highlighted language barriers to safety training, writing: "Employment in the construction industry, low likelihood of receiving safety training (due both to language barriers and reduced employer incentives to train temporary workers), employers flouting safety regulations with little fear of being reported by their undocumented employees, and severe economic pressures" force the undocumented to take less desirable jobs.


Story Source:

The above story is based on materials provided by Cornell University. The original article was written by H. Roger Segelken. Note: Materials may be edited for content and length.


Journal Reference:

  1. Matthew Hall, Emily Greenman. The Occupational Cost of Being Illegal in the United States: Legal Status, Job Hazards, and Compensating Differentials. International Migration Review, 2014; DOI: 10.1111/imre.12090

Mechanism explains complex brain wiring

 

June 11, 2014

VIB - Flanders Interuniversity Institute for Biotechnology

How neurons are created and integrate with each other is one of biology’s greatest riddles. Now, a researcher unravels a part of the mystery by describing a mechanism that explains novel aspects of how the wiring of highly branched neurons in the brain works. These new insights into how complex neural networks are formed are very important for understanding and treating neurological diseases.


Researcher Dietmar Schmucker from VIB-KU Leuven unravels a part of the mystery in Science magazine. He describes a mechanism that explains novel aspects of how the wiring of highly branched neurons in the brain works. These new insights into how complex neural networks are formed are very important for understanding and treating neurological diseases.

Neurons, or nerve cells

It is estimated that a person has 100 billion neurons, or nerve cells. These neurons have thin, elongated, highly branched offshoots called dendrites and axons. They are the body's information and signal processors. The dendrites receive electrical impulses from the other neurons and conduct these to the cell body. The cell body then decides whether stimuli will or will not be transferred to other cells via the axon.

The brain's wiring is very complex. Although the molecular mechanisms that explain the linear connection between neurons have already been described numerous times, little is as yet known about how the branched wiring works in the brain.

The connections between nerve cells

Prior research by Dietmar Schmucker and his team lead to the identification of the Dscam1 protein in the fruit fly. The neuron can create many different protein variations, or isoforms, from this same protein. The specific set of isoforms that occurs on a neuron's cell surface determines the neuron's unique molecular identity and plays an important role in the establishment of accurate connections. In other words, it describes why certain neurons either come into contact with each other or reject each other.

Recent work by Haihuai H and Yoshiaki Kise from Dietmar's team indicates that different sets of Dscam1 isoforms occur inside one axon, between the newly formed offshoots amongst each other. If this was not the case, then only linear connections could come about between neurons. These results indicate for the first time the significance of why different sets of the same protein variations can occur in one neuron and it could explain mechanistically how this contributes to the complex wiring in our brain.

Clinical impact

Although this research was done with fruit flies, it also provides new insights that help explain the wiring and complex interactions of the human brain and shine a new light on neurological development disorders such as autism. Thorough knowledge of nerve cell creation and their neural interactions is considered essential knowledge for the future possibility of using stem cell therapy as standard treatment for certain nervous system disorders.


Story Source:

The above story is based on materials provided by VIB - Flanders Interuniversity Institute for Biotechnology. Note: Materials may be edited for content and length.


Journal Reference:

  1. H. He, Y. Kise, A. Izadifar, O. Urwyler, D. Ayaz, A. Parthasarthy, B. Yan, M.-L. Erfurth, D. Dascenco, D. Schmucker. Cell-intrinsic requirement of Dscam1 isoform diversity for axon collateral formation. Science, 2014; 344 (6188): 1182 DOI: 10.1126/science.1251852

Human language's deep origins appear to have come directly from birds, primates

 

Far from being a mere curiosity, the silvery gibbon may hold clues to the development of language in humans. In a newly published paper, two MIT professors assert that by re-examining contemporary human language, we can see indications of how human communication could have evolved from the systems underlying the older communication modes of birds and other primates.

From birds, the researchers say, we derived the melodic part of our language, and from other primates, the pragmatic, content-carrying parts of speech. Sometime within the last 100,000 years, those capacities fused into roughly the form of human language that we know today.

But how? Other animals, it appears, have finite sets of things they can express; human language is unique in allowing for an infinite set of new meanings. What allowed unbounded human language to evolve from bounded language systems?

"How did human language arise? It's far enough in the past that we can't just go back and figure it out directly," says linguist Shigeru Miyagawa, the Kochi-Manjiro Professor of Japanese Language and Culture at MIT. "The best we can do is come up with a theory that is broadly compatible with what we know about human language and other similar systems in nature."

Specifically, Miyagawa and his co-authors think that some apparently infinite qualities of modern human language, when reanalyzed, actually display the finite qualities of languages of other animals -- meaning that human communication is more similar to that of other animals than we generally realized.

"Yes, human language is unique, but if you take it apart in the right way, the two parts we identify are in fact of a finite state," Miyagawa says. "Those two components have antecedents in the animal world. According to our hypothesis, they came together uniquely in human language."

Introducing the 'integration hypothesis'

The current paper, "The Integration Hypothesis of Human Language Evolution and the Nature of Contemporary Languages," is published this week in Frontiers in Psychology. The authors are Miyagawa; Robert Berwick, a professor of computational linguistics and computer science and engineering in MIT's Laboratory for Information and Decision Systems; and Shiro Ojima and Kazuo Okanoya, scholars at the University of Tokyo.

The paper's conclusions build on past work by Miyagawa, which holds that human language consists of two distinct layers: the expressive layer, which relates to the mutable structure of sentences, and the lexical layer, where the core content of a sentence resides. That idea, in turn, is based on previous work by linguistics scholars including Noam Chomsky, Kenneth Hale, and Samuel Jay Keyser.

The expressive layer and lexical layer have antecedents, the researchers believe, in the languages of birds and other mammals, respectively. For instance, in another paper published last year, Miyagawa, Berwick, and Okanoya presented a broader case for the connection between the expressive layer of human language and birdsong, including similarities in melody and range of beat patterns.

Birds, however, have a limited number of melodies they can sing or recombine, and nonhuman primates have a limited number of sounds they make with particular meanings. That would seem to present a challenge to the idea that human language could have derived from those modes of communication, given the seemingly infinite expression possibilities of humans.

But the researchers think certain parts of human language actually reveal finite-state operations that may be linked to our ancestral past. Consider a linguistic phenomenon known as "discontiguous word formation," which involve sequences formed using the prefix "anti," such as "antimissile missile," or "anti-antimissile missile missile," and so on. Some linguists have argued that this kind of construction reveals the infinite nature of human language, since the term "antimissile" can continually be embedded in the middle of the phrase.

However, as the researchers state in the new paper, "This is not the correct analysis." The word "antimissile" is actually a modifier, meaning that as the phrase grows larger, "each successive expansion forms via strict adjacency." That means the construction consists of discrete units of language. In this case and others, Miyagawa says, humans use "finite-state" components to build out their communications.

The complexity of such language formations, Berwick observes, "doesn't occur in birdsong, and doesn't occur anywhere else, as far as we can tell, in the rest of the animal kingdom." Indeed, he adds, "As we find more evidence that other animals don't seem to posses this kind of system, it bolsters our case for saying these two elements were brought together in humans."

An inherent capacity

To be sure, the researchers acknowledge, their hypothesis is a work in progress. After all, Charles Darwin and others have explored the connection between birdsong and human language. Now, Miyagawa says, the researchers think that "the relationship is between birdsong and the expression system," with the lexical component of language having come from primates. Indeed, as the paper notes, the most recent common ancestor between birds and humans appears to have existed about 300 million years ago, so there would almost have to be an indirect connection via older primates -- even possibly the silvery gibbon.

As Berwick notes, researchers are still exploring how these two modes could have merged in humans, but the general concept of new functions developing from existing building blocks is a familiar one in evolution.

"You have these two pieces," Berwick says. "You put them together and something novel emerges. We can't go back with a time machine and see what happened, but we think that's the basic story we're seeing with language."

Miyagawa acknowledges that research and discussion in the field will continue, but says he hopes colleagues will engage with the integration hypothesis.

"It's worthy of being considered, and then potentially challenged," Miyagawa says.

It's the last bite that keeps you coming back for more

 

June 11, 2014

Association for Psychological Science

Your memory for that last bite of a steak or chocolate cake may be more influential than memory for the first bite in determining when you want to eat it again, according to research. The fact that memory for the last few bites seems to drive our decisions about when to eat a food again may be particularly relevant in places where portion sizes tend to be larger and are likely to result in lower end enjoyment:


Your memory for that last bite of a steak or chocolate cake may be more influential than memory for the first bite in determining when you want to eat it again, according to research published in Psychological Science, a journal of the Association for Psychological Science.

Our memories for foods are often vivid, especially when we experience foods that are terrifyingly bad or delightfully good. The findings from this research shed light on how memories for food are formed and how they guide our decisions about how soon we're willing to eat a food again.

"Research has told us a lot about factors that influence what foods people want to consume, but less is known about factors that influence when they want to consume a particular food again," explains researcher and lead author Emily Garbinsky of the Stanford University Graduate School of Business.

"Companies profit not only from the sale of food items but also from how frequently those particular items are sold, and the impact of eating both healthy and unhealthy foods on people's health is determined not only by how much they eat but how often those foods are eaten," says Garbinsky. "As such, it seemed important to get a better understanding of what influences the amount of time that passes until consumption is repeated."

Garbinsky and colleagues Carey Morewedge of the Boston University School of Management and Baba Shiv of the Stanford University Graduate School of Business investigated the question in a series of studies.

In one study, the researchers asked 134 undergraduate students to sample 3 flavors of Nut Thin crackers and then choose one to eat. They were then given a specific number of crackers and were asked to rate how much they enjoyed each one after they ate it.

The results revealed that students who had eaten the larger portion (15 crackers) reported significantly lower enjoyment at the end than those who had eaten the smaller portion (3 crackers).

These findings replicate previous findings on "sensory-specific satiety": Each bit of food is less pleasant than the one before it. Thus, the bigger the portion, the less enjoyment you get out of the last few bites.

More importantly, participants' enjoyment of the last cracker (manipulated by portion size) seemed to influence how soon the students wanted to eat the crackers again: Participants who ate a small portion typically opted to receive a giveaway box of Nut Thins sooner than did participants who ate the larger portion.

These results suggest that the most recent tastes experienced in the last few bites of a given food drive our decisions about when to eat that food again, a finding that they researchers replicated in a second study.

Garbinsky and colleagues hypothesized that this so-called "recency effect" might be explained by memory interference induced by the repetitiveness of eating:

"A glass of juice, bowl of ice cream, or bag of potato chips contains many units of very similar stimuli that are consumed one sip or bite at a time until the entire portion has been eaten," they write.

So, if we take a lot of bites of the same food in succession, our memory for the last bites may interfere with our ability to accurately remember the initial bites of that food.

Garbinsky and colleagues were able to eliminate this memory interference by reminding participants of their previous ratings as they continued to consume and rate a glass of juice. These participants were more accurate in remembering how much they enjoyed the first ounce of juice and they opted to receive a giveaway container of juice sooner than did the participants who rated each ounce of juice without being reminded of their previous ratings.

"This finding is important in that it suggests that large portions may be somewhat detrimental to companies because they extend the amount of time that passes until repeat consumption occurs," says Garbinsky. "And it's also important to the public, as eating too much of a favorite -- or healthy -- food may increase the delay until one wants to eat it again."

The studies do suggest that certain strategies -- such as thinking back to the first few bites -- could be used to encourage consumers to eat a food again soon. But, as tantalizing as these insights may be, Garbinsky cautions that more research is needed to investigate whether the findings translate to real-world settings, in which consumers have more control over deciding what and how much they eat.

Risk factors for hospital readmissions identified

 

June 11, 2014

Wake Forest Baptist Medical Center

According to researchers, about half of readmissions could be avoided. The goal of this single-center study was to identify at the time of discharge the factors that are strongly associated with readmission in patients with ischemic and hemorrhagic stroke. The study compared 79 stroke patients who were readmitted to the hospital within 30 days to 86 controls over an 18 month period.


Therefore, there is significant interest in identifying factors that influence readmission rates, especially those that can be identified prior to discharge. To pinpoint which stroke patients are most at risk, researchers at Wake Forest Baptist Medical Center undertook a retrospective case-control study to determine factors associated with readmission within 30 days. The study is published in the June 11 online edition of the American Journal of Medical Quality.

"If you can recognize who is at risk, you can really focus on those people to try to make sure they are treated appropriately and followed closely," said Cheryl Bushnell, M.D., associate professor of neurology at Wake Forest Baptist and director of its Comprehensive Stroke Center.

The goal of this single-center study was to identify at the time of discharge the factors that are strongly associated with readmission in patients with ischemic and hemorrhagic stroke. The study compared 79 stroke patients who were readmitted to the hospital within 30 days to 86 controls over an 18 month period. There were no significant differences in age, gender or race-ethnicity between the stroke patients and controls.

The researchers found that readmitted patients were significantly more likely to have a prior diagnosis of congestive heart failure, coronary artery disease, cancer or absence of hyperlipidemia, elevated lipid (fat) levels in the blood. In addition, readmitted patients were more likely to have been hospitalized two or more times during the year prior to the initial stroke admission.

The findings suggest that stroke severity and number of hospitalizations within the year prior to the stroke admission are important predictors of subsequent readmission within 30 days, independent of other clinical factors, Bushnell said.

"If our model is validated in a larger study, it could then be used in electronic health records to provide a potentially reproducible, efficient and effective means of selecting patients most at risk for subsequent hospital readmission. A logical next step is to develop innovative tools and programs for stroke patients to keep patients from being readmitted," Bushnell said.

A limitation of the study was that data was collected solely at discharge, she said, adding that subsequent research will include evaluation of post-discharge data.


Story Source:

The above story is based on materials provided by Wake Forest Baptist Medical Center. Note: Materials may be edited for content and length.


Journal Reference:

  1. Roy E. Strowd et al. Predictors of 30-Day Hospital Readmission Following Ischemic and Hemorrhagic Stroke. American Journal of Medical Quality, June 2014 DOI: 10.1177/1062860614535838

Pot Isn't Harmless, Top U.S. Health Official Says

 

WEDNESDAY June 4, 2014, 2014 -- States joining the march toward marijuana legalization need to take a step back and consider the drug's adverse effects on health, the U.S. drug "czar" argues in a new paper.

Marijuana is potentially addictive, proven to contribute to fatal motor-vehicle crashes, and can disrupt the brain function and learning of young users, says Dr. Nora Volkow, director of the U.S. National Institute on Drug Abuse.

Legalizing pot will lead to the sort of nationwide health problems now attributed to alcohol and tobacco, said Volkow, lead author of a review article in the June 5 New England Journal of Medicine.

Tobacco and alcohol have a far greater impact on health in the United States than illicit drugs, as their legal status make them more widely available for use, she noted.

"By making marijuana legal, you have more widespread use and many more health implications," Volkow said. "We don't need a third legal drug. We already have enough problems with the two we have."

The pro-marijuana advocacy group NORML agrees that pot "is not a harmless substance," Deputy Director Paul Armentano said.

"But its potential risks to the individual and to society do not warrant its present schedule I illicit status under federal law, a classification that improperly argues that the plant lacks any accepted therapeutic value and that its risks equal those of heroin," Armentano said.

Volkow is making her argument as the political winds continue to shift toward pot legalization.

Last week, the Republican-controlled U.S. House of Representatives voted in favor of preventing the federal government from interfering with states that allow marijuana use for medical reasons. Medical marijuana is legal in nearly half the states.

"Public opinion is shifting," Rep. Dana Rohrabacher, R-Calif., said at the time.

In the new article, Volkow and colleagues said marijuana is addictive, contrary to popular opinion. Research has shown that 9 percent of people who try pot will become addicted, she said. Pot's effect is even stronger among young people, addicting 17 percent of users under 18, she said.

"This is something that a lot of people who are pro-marijuana deny. The evidence shows otherwise," Volkow said.

Marijuana also poses a public safety risk. People intoxicated by pot are 3 to 7 times more likely to cause a car crash than someone sober, Volkow said.

Most troubling is the tendency for teens and young adults to use pot and alcohol at the same time, which increases the risk of a wreck more than if they used either drug on its own, she added.

Pot also appears to affect brain development in young users. Scans have shown that teenage pot users suffer from decreased brain activity and impaired connectivity between key brain areas, Volkow said.

"During adolescence, there is a tremendous amount of neuroplasticity," she said. "Regular use of marijuana is likely to have an adverse effect on the way the human brain gets connected and organized."

This may explain why frequent use by teens is linked to lower IQ and higher odds of dropping out of school, the report noted.

Volkow said other research has shown marijuana can:

  • Serve as a "gateway" drug.
  • Impair school performance.
  • Exacerbate mental illnesses such as schizophrenia.
  • Increase the risk of health problems such as chronic bronchitis and cardiovascular disease.

Legislators considering marijuana legalization should consider these effects, as well as all the gaps in current knowledge of pot's impact on human health, Volkow said.

"What is unfortunate in my view is that the information that's being presented is not objective. It's very subjective," she said. "We all want to think there is this drug that could make us feel relaxed and good with no harmful effects. That's a lovely fairy tale we all wish were true."

However, Armentano argues that "the ongoing criminalization of marijuana is a disproportionate response to what, at worst, is a health issue, not a criminal justice issue."

The adverse health consequences associated with alcohol, tobacco, and prescription drugs are far more dangerous and costlier to society than the responsible adult use of cannabis, he said. "It's precisely because of these consequences that these products are legally regulated and their use is restricted to particular consumers and specific settings," he said.

Legalization and regulation of marijuana will "best reduce the risks associated with the plant's consumption or abuse," Armentano said.

More information

For more information on marijuana, visit the U.S. National Library of Medicine.

Quebec city

 

Quebec, also Québec, Quebec City, or Québec City (French: Ville de Québec), is the capital of the Canadian province of Quebec. As of 2011 the city has a population of 516,622, and the metropolitan area has a population of 765,706, making it the second most populous city in Quebec after Montreal, which is about 233 km (145 mi) to the southwest.

The narrowing of the Saint Lawrence River proximate to the city's promontory, Cap-Diamant (Cape Diamond), and Lévis, on the opposite bank, provided the name given to the city, Kébec, an Algonquin word meaning "where the river narrows". Founded in 1608 by Samuel de Champlain, Quebec City is one of the oldest cities in North America. The ramparts surrounding Old Quebec (Vieux-Québec) are the only fortified city walls remaining in the Americas north of Mexico, and were declared a World Heritage Site by UNESCO in 1985 as the 'Historic District of Old Québec'.

According to the federal and provincial governments, Québec is the city's official name in both French and English, although Quebec City (or its French equivalent, Ville de Québec) is commonly used, particularly to distinguish the city from the province. The city's most famous landmark is the Château Frontenac, a hotel which dominates the skyline. The National Assembly of Quebec (provincial legislature), the Musée national des beaux-arts du Québec (National Museum of Fine Arts of Quebec), and the Musée de la civilisation (Museum of Civilization) are found within or near Vieux-Québec.

The Morrin Center Library, Vieux Quebec, Quebec City, QC, CanadaThe Museum of Civilization located in Quebec CityThe Musée National des Beaux-Arts du Quebec, Quebec City, QC, Canadanotre-dame-quebec_80085_990x742Lower Vieux Quebec, also known as Quartier Petit Champlain, Quebec City, Quebec, CanadaJ.A. Moisan, the oldest grocery store (epicerie) in North America located in the Quartier St. Jean Baptiste along rue St. Jean, also has a 4 room Bed and Breakfast above.Dufferin TerraceThe Ramparts of Quebec City, Quebec City, QC, Canadacarriage-ride-quebec-city_80070_990x742Le Cercle restaurant in Nuovo Saint Roch neighborhood, Quebec City, Quebec, CanadaPanache Restaurant located in the Auberge Saint Antoine. The menu features local meats and produce. The Auberge Saint Antoine hotel located in Quebec City's Old Port and across the street from the St. Lawrence district was built on an archeological site.  The archeological fragments and finds are incorporated into wall displays throughout the hotel.Quebec City, Quebec, CanadaMarché du Vieux-Port in Quebec City has seasonal stalls for locals to purchase everything from home made cheese to flowers and fresh fish, Vieux Quebec, Quebec, CanadaThe Chateau Frontenac, the world's most photographed hotel, dominates the Quebec City Skyline

The Parliament Building and the Tourney Fountain, Quebec City, QC, Canada

FDA Approves Jublia

 

Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis

LAVAL, Quebec, June 9, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jublia (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails.

"We acquired Jublia through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia from pre-IND stage through Clinical Phases 1, 2 and 3," said J. Michael Pearson, chairman and chief executive officer. "We are working quickly to get this important product launched in the U.S. and Canada in the third quarter of 2014. We anticipate favorable managed care coverage in the U.S., similar to other branded antifungal agents, with peak sales of $300-$800 million in the U.S. alone and we are also working with other regulatory agencies around the world on further approvals. This is the fourth product, sourced from our acquisition of Dow Pharmaceutical Sciences, for which we have received FDA approval – the other three being 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya® and Retin-A Micro (tretinoin) Gel microsphere 0.08%. We have also filed a new treatment for acne, Onexton™, which has a PDUFA date of November 30, 2014. All these compounds came through our Dow acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory."

Onychomycosis is a common and destructive nail infection that is currently undertreated largely because of the limitations of available treatments. Currently, over-the-counter or prescription topical treatments provide limited efficacy and are often administered in conjunction with frequent debridement, or the scraping, cutting or removal of the nail. Prescription oral treatments are limited by drug interactions and serious safety concerns.

"Onychomycosis is not only embarrassing and uncomfortable, but can lead to permanent nail damage and limited mobility in the general population," said American Podiatric Medical Association Executive Director and CEO Glenn B. Gastwirth, DPM. "We welcome the approval of Jublia® and encourage people with onychomycosis of the toenails to discuss their condition with their podiatrist, or other healthcare professional to find a treatment that's right for them."

The licensor and business partner for efinaconazole, Kaken Pharmaceutical, has also agreed to supply Valeant with the finished dosage form of Jublia for the U.S. market.

 

Information about Jublia (efinaconazole 10% topical solution)

Jublia (efinaconazole 10% topical solution), is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).

Being a solution, Jublia is applied daily to the nail with a novel bottle that has a built-in flow-through brush applicator. It dries quickly and there is no need to remove excess product. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury.

Jublia has been extensively studied prior to its approval. The two positive pivotal studies that were the basis for approval were published last year in the prestigious Journal of the American Academy of Dermatology. These international studies were conducted in 1,655 subjects with onychomycosis, including subjects in Canada.

For the pivotal studies, the primary endpoint was complete cure at Week 52, which required that the target nail show no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with Jublia were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with Jublia were completely cured, compared to only 5.5% of subjects treated with vehicle.

Adverse events that were reported were generally mild and transient and were similar between subjects treated with Jublia and vehicle. The most commonly reported adverse events in patients treated with Jublia were application site dermatitis and application site vesicles.

 

About Onychomycosis

Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi that typically occurs under the toenail, though fingernails may also be affected. Approximately 35 million Americans suffer from onychomycosis, most of whom are men between 50 and 70 years of age. The fungi that cause onychomycosis live in warm, moist environments, including swimming pools and showers, and may invade the skin through tiny cuts or small separations between the nail and nail bed.

The condition typically begins as a small white or yellow spot beneath the nail, and causes nail discoloration, thickening and/or distortion, pain, detachment of the nail from the nail bed and irregular surface changes. Once onychomycosis begins, it can persist indefinitely if not treated and may cause permanent nail damage. Currently 85 percent of onychomycosis patients are untreated.

 

About Valeant Pharmaceuticals International, Inc.

Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.

FDA Approves Bunavail Buccal Film for the Maintenance Treatment of Opioid Dependence

 

RALEIGH, N.C., June 9, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) (NASDAQ: BDSI) received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

BUNAVAIL was designed using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA®), allowing for the efficient and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual (under the tongue) dosage forms currently available. BUNAVAIL has twice the bioavailability (drug absorbed into the body) of buprenorphine compared to Suboxone, the market leader in this category. As a result of the improved absorption of buprenorphine with BUNAVAIL, which is the direct result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.

BUNAVAIL is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration. The ability of BUNAVAIL to stick on the inside of the cheek, unlike sublingual products that need to be kept in place under the tongue until they dissolve, allows patients to talk, swallow and go about normal daily activities while the medication is being consistently absorbed.

"BUNAVAIL is a novel treatment approach for the more than two million people in the U.S. afflicted with opioid dependence," said Gregory Sullivan, M.D., principal investigator of the Phase 3 BUNAVAIL safety study and an addiction specialist and Medical Director of Parkway Medical Center in Birmingham, Alabama. "BUNAVAIL utilizes advanced drug delivery technology to fulfill an important need for treatment options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with sublingual administration and possibly help improve treatment compliance."

Dr. Sullivan continued, "BUNAVAIL was assessed in a Phase 3 clinical study in 249 patients who were converted from Suboxone sublingual tablet or film to BUNAVAIL. In this study, BUNAVAIL demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence as demonstrated by the high study retention rate and the low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period. The majority of patients who participated found BUNAVAIL easy to use and pleasant in taste. Additionally, prior to conversion to BUNAVAIL, about 40 percent of patients were experiencing constipation while receiving Suboxone tablet or film, a common problem with chronic opioid use, and more than two-thirds of these patients reported resolution of symptoms when they switched from Suboxone to BUNAVAIL."

"FDA's approval of BUNAVAIL is another example of how we are creating products to help patients in their battle to overcome debilitating medical issues such as opioid dependence and is a tribute to the dedication and focus of our employees," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "This is also a transformative event for BDSI, as we will be launching a product with our own dedicated sales force for the first time, which we believe will lead to significant value creation for our shareholders. We plan to share the details of our overall commercial plans later this summer as we approach the launch of BUNAVAIL. I am confident that with the experience of the marketing and sales resources we have in place, we will have a positive launch and overall market reception for BUNAVAIL."

"Opioid addiction is a serious issue that can often be difficult to treat," said Tim Lepak, President of the National Alliance of Advocates for Buprenorphine Treatment (NAABT). "People with opioid addiction face significant challenges in their efforts to rebuild their lives and achieve sustained addiction remission. It is important that patients have treatment options that are effective, safe and easy to use in order to provide them with their best chance for success. I believe people addicted to prescription opioids and heroin will welcome BUNAVAIL as a novel treatment option."

BUNAVAIL is the first mucoadhesive buccal film formulation of buprenorphine to compete directly with Suboxone sublingual film. In 2013, sales of Suboxone sublingual film increased to more than $1.3 billion in the U.S. while the total market grew to more than $1.7 billion, driven by a 14 percent increase in prescriptions according to data from Symphony Health Solutions.

BDSI plans to launch BUNAVAIL in late third quarter 2014 and anticipates peak sales potential of BUNAVAIL of up to $250 million in the U.S. BDSI will also begin entertaining commercial partnerships for BUNAVAIL outside of the U.S. In March 2014, BDSI announced it had entered into an agreement with Quintiles to support the launch of BUNAVAIL. Under terms of the agreement, Quintiles will provide a range of services to support the launch and subsequent commercialization of BUNAVAIL in the U.S., including recruiting and training a field sales force. In the U.S., nearly 5,000 physicians are responsible for approximately 90 percent of prescriptions for buprenorphine products for the treatment of opioid dependence, according to recent data from Symphony Health Solutions.

Separately, BDSI has entered into an agreement with Ashfield Market Access to provide managed markets and trade support for BUNAVAIL. Ashfield Market Access, which is led by industry veterans including Steve Stefano, who led GlaxoSmithKline's managed markets group for more than 20 years, will be responsible for executing a payer strategy aimed at maximizing patient access to BUNAVAIL.

BDSI will be providing additional information regarding the FDA approval of BUNAVAIL and commercialization plans in the upcoming weeks. BDSI will be presenting on Wednesday, June 11 at 3:20 PM Central Time (4:20 PM Eastern Time) at the 34th Annual William Blair Growth Stock Conference in Chicago which will be webcast live and can be accessed at www.bdsi.com. BDSI also plans to hold an analyst and investor update meeting later in the summer to provide additional insight into plans for the late third quarter launch of BUNAVAIL.

 

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.

BDSI's pain franchise consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it will be marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).

BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Pharmaceuticals. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.

BDSI's approved product for the maintenance treatment of opioid dependence is BUNAVAIL, which was approved by the FDA in June 2014 and is expected to be commercially launched during late third quarter 2014.

BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.

 

About Opioid Dependence

Opioid dependence is a significant and undertreated condition in the U.S., with over two million people dependent on opioids in 2012 according to the National Institute on Drug Abuse (NIDA). Suboxone, which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.3 billion according to data from Symphony Health Solutions. According to the World Health Organization, opioid dependence is a complex health condition that often requires long-term treatment and care. The treatment of opioid dependence is important to reduce its health and social consequences and to improve the well-being and social functioning of people affected. The main objectives of treating and rehabilitating persons with opioid dependence are to reduce dependence on illicit drugs; to reduce the morbidity and mortality caused by the use of illicit opioids, or associated with their use, such as infectious diseases; to improve physical and psychological health; to reduce criminal behavior; to facilitate reintegration into the workforce and education system and to improve social functioning. The achievement of a drug free state is the ideal and ultimate objective.

About BUNAVAIL

INDICATION

BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).

IMPORTANT SAFETY INFORMATION

Keep BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away.

Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been reported.

Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal symptoms.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you.

BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines. Your doctor will prescribe a dose of BUNAVAIL that may be different than other buprenorphine-containing medicines you may have been taking.

BUNAVAIL can cause serious life‐threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines, sedatives, tranquilizers or alcohol. You should not drink alcohol while taking BUNAVAIL, as this can lead to loss of consciousness or even death.

Like other opioids (e.g., heroin, methadone, oxycodone, morphine), BUNAVAIL may produce orthostatic hypotension ('dizzy spells') in ambulatory individuals.

Common side effects of BUNAVAIL include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in sleep (insomnia), fatigue and sleepiness.

Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

BUNAVAIL can be abused in a manner similar to other opioids, legal or illicit. Keep BUNAVAIL in a safe place. Do not give your BUNAVAIL to other people, it can cause them harm or even death. Selling or giving away this medicine is against the law. BUNAVAIL is not recommended in patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment.

Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL, tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.

Before taking BUNAVAIL, talk to your doctor if you are breast‐feeding or plan to breast‐feed your baby. BUNAVAIL can pass into your breast milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems. Your doctor should tell you about the best way to feed your baby if you are taking BUNAVAIL.

This is not a complete list of potential adverse events associated with BUNAVAIL Buccal Film. Please see full Prescribing Information for a complete list.

To report negative side effects associated with taking BUNAVAIL Buccal Film, please call 1-800-469-0261. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

For more information, please see full Prescribing Information and Medication Guide for BUNAVAIL™ Buccal Film (CIII).

Source: BioDelivery Sciences International, Inc.

Posted: June 2014

 

Related Articles:

        Bunavail (buprenorphine and naloxone) FDA Approval History

Breast Cancer Drug Herceptin Linked to Risk of Heart Problems: Study

 

MONDAY June 9, 2014, 2014 -- As many as one in 10 women taking the breast cancer drug trastuzumab (Herceptin) will experience some type of heart problem, according to new research.

The good news from this study is that these problems typically reverse once treatment is finished.

"The overall message here is one of tremendous reassurance," said study researcher Dr. Brian Leyland-Jones, vice president of molecular and experimental medicine at Avera Cancer Institute in Sioux Falls, S.D.

The study was published June 9 in the Journal of Clinical Oncology online. Roche, the maker of Herceptin, provided research funding. Some of the study's co-authors work for Roche or are advisers or consultants.

Herceptin is used in breast cancers that test positive for HER 2 (human epidermal growth factor receptor 2), which promotes the growth of cancer cells. Herceptin kills the cells, and is known to boost survival, both in those with breast cancer that has spread and to those with HER2-positive early breast cancer. It's given after primary treatments for breast cancer, such as surgery, chemotherapy and radiation.

However, heart problems have been linked with the drug's use, including congestive heart failure and a decrease in how well the heart can pump blood out of its main pumping chamber, the left ventricle.

Leyland-Jones and other researchers from the United States, Belgium and other countries followed more than 5,000 women with early stage breast cancer for an average of eight years. They were evaluating how often cardiac problems occurred and, when they did, whether they disappeared after the women had taken the drug for the recommended time period.

The researchers followed three groups, each with about 1,700 women. One group did not get trastuzumab. The second group took it for one year and the third for two years. The current standard of care is one year, according to Leyland-Jones.

Nearly 10 percent of women in the two-year group, and about 5 percent of those in the one-year group, had to discontinue the drug due to adverse cardiac problems, such as congestive heart failure, a decrease in the heart's blood-pumping ability or other issues.

Three cardiac deaths occurred in the two-year group, none occurred in the one-year treatment group, and two deaths occurred in the no-drug group, according to the study.

Congestive heart failure occurred in less than 1 percent of both drug groups. "What this confirms is a very low incidence of cardiac events, even when you give two years of the drug, which is no longer practiced," Leyland-Jones said.

Blood pumping problems occurred in about 7 percent of the two-year group and 4 percent of the one-year group.

The study authors don't know for sure why the drug is associated with heart issues, but they noted that HER2 is linked with the regulation of cell growth and survival in the heart. Using the drug may take away those heart protective effects.

After stopping the drug, the blood pumping problems resolved in more than 87 percent of the two-year group and more than 81 percent of the one-year group.

The new findings reaffirm previous research with shorter follow-up times, said Dr. Joanne Mortimer, director of Women's Cancer Programs and co-director of the Breast Cancer Program at City of Hope Cancer Center in Duarte, Calif. She reviewed the findings but was not involved in the study.

The new study reaffirms that the heart problems linked with the drug don't increase with time, she said, "and that's what is important."

"There's no question this is a really important drug," Mortimer said, as previous studies have shown trastuzumab to improve survival from this more aggressive form of breast cancer.

Doctors know that women with a history of high blood pressure and those over 65 are at higher risk of heart problems while on the drug, she said.

Women should have a cardiac assessment before starting trastuzumab, Leyland-Jones said, and should have cardiac monitoring while they are taking it so that any cardiac problems related to the drug can be found and treated early.

More Information

To learn more about breast cancer treatments, visit American Cancer Society.

Levodopa May Beat Newer Meds for Long-Term Parkinson's Care: Study

 

WEDNESDAY June 11, 2014, 2014 -- When it comes to which drug works best for patients with newly diagnosed Parkinson's disease, older may still be better, a new study finds.

Research published June 10 in The Lancet finds that the dopamine drug levodopa still outperforms newer medications for the long-term care of people newly diagnosed with Parkinson's.

"This study lays to rest lingering questions among both people with Parkinson's disease and their doctors about which drug is most beneficial when first beginning treatment for the disease," said James Beck, vice president of scientific affairs at the Parkinson's Disease Foundation (PDF).

In the largest-ever trial of Parkinson's disease treatment, levodopa offered patients better mobility and a higher quality of life than the two main alternatives -- drugs called dopamine agonists and monoamine oxidase type B (MAO-B) inhibitors.

The study included more than 1,600 newly diagnosed Parkinson's disease patients who were randomly selected to take either levodopa or one of the other two treatments. They were followed for up to seven years.

"Although the differences in favor of levodopa are small, when you consider the short- and long-term benefits, side effects, quality of life for patients, and costs, the old drug levodopa is still the best initial treatment strategy for most patients," study leader Richard Gray of the University of Oxford in the United Kingdom, said in a journal news release.

Levodopa remains the most widely used treatment for Parkinson's, but prolonged use of the drug can lead to involuntary muscle spasms and movement problems. There is less risk of developing these complications with the two newer types of drugs, but the newer meds are also more likely to cause side effects such as nausea, hallucinations, swelling and sleep problems, the researchers said.

The new study is an improvement on prior efforts, Gray said. "Previous studies included too few patients, had short follow-up, and focused on the clinicians' assessments of motor symptoms rather than asking patients how the drugs affected their overall quality of life," he explained. "So, for many years there has been uncertainty about the risks and benefits of starting treatment with these different classes of Parkinson's disease drugs."

The study findings are likely to "change clinical practice worldwide, with the majority of patients from now on starting therapy with levodopa," study clinical coordinator Carl Clarke, from the University of Birmingham in the United Kingdom, said in the news release.

The PDF's Beck agreed.

"For years, the community has asked whether it is best to begin treatment with levodopa, which remains the gold-standard therapy for movement symptoms, or with alternatives such as dopamine agonists and MAO-B inhibitors," Beck said. "It turns out that levodopa may slightly edge the other drugs as an initial therapy."

However, that doesn't mean that the other medications won't be the best choice for certain patients, Beck added.

"All three [options] offer very similar effects in the near and long term," he said. "Thus, these results should allow people with Parkinson's and their doctors to choose therapies that make sense for them -- clinically as well as financially."

More information

The U.S. National Library of Medicine has more about Parkinson's disease.