University of Iowa researchers create new staph infection vaccine

by Vanessa Miller, medcitynews.com

December 30th 2013 8:21 PM

University of Iowa researchers have developed a new vaccine to protect against Staphylococcus-caused pneumonia, and they hope it will be preventing illnesses and saving lives in as soon as two years.

The vaccine targets infections caused by Staphylococus aureus bacteria, commonly called staph, including drug-resistant strains like MRSA that kill thousands of Americans every year. Because some influenza-related deaths are caused by secondary staph infections, the new vaccine also could lessen the impact of the seasonal flu, said UI professor Patrick Schlievert, chair of microbiology in the UI Carver College of Medicine who led the vaccination research.

"We could bring the flu death rate down to near zero," Schlievert said.

Findings of the UI-led research were published this month in the Journal of Infectious Disease and in a blog for Science magazine. Schlievert said the next step is to approach the U.S. Food and Drug Administration about beginning a safety study in the coming months.

A clinical trial would follow -- possibly by the end of 2014 or early 2015, Schlievert said. Ideally, he said, the new vaccine would be given with the Tdap shot, which protects against tetanus, diphtheria and pertussis.

"I would like to see it available in two years," he said.

Staph bacteria are the most significant cause of serious infection and infection-linked fatalities in the United States, according to the U.S. Centers for Disease Control and Prevention. About 70,000 Americans develop staphylococcal pneumonia every year, many of whom die.

Prior attempts at a vaccine have failed, Schlievert said, and people continue to get sick and die.

"There is a huge need for the vaccine," he said. "So can we move this forward faster than slower?"

The new vaccine works by targeting toxins produced by staph and responsible for serious and sometimes deadly infection symptoms like fever, low blood pressure and toxic shock. The UI-led research analyzed whether a vaccine could block the action of the toxins and prevent the illness.

Researchers used an animal model of staph infection that resembled a human one and found that vaccination against three staph toxins provided "almost complete protection against staph infections," according to UI News Services. The animals in the study were protected from illness even when given high doses of bacteria directly in their lungs, Schlievert said.

And, seven days later, the animals not only were alive but free of the disease-causing bacteria.

"Our study suggests that vaccination against these toxins may provide protection against all strains of staph," Schlievert said.

Based on research standards measuring the likelihood that the findings occurred by chance, Schlievert said his team's results are "unbelievably significant."

"There is no chance that happened by accident," he said.

News of the new vaccine that could ease the effects of seasonal flu, among other things, comes as this season's flu virus ramps up nationwide. In 90 percent of the past 20 years, flu season peaks from January to March, and activity so far this season is elevated both nationally and regionally, according to the CDC.

In Iowa's four-state region since Sept. 29, 17.1 percent of patients seen for flu-like symptoms tested positive for the virus, according to the CDC. When looking just at Iowa for the week ending Dec. 21, 17.2 percent of patients seen for flu symptoms tested positive, the CDC reports.

During the 2012-13 season, people aged 65 and older were hit hard by the bug and were hospitalized at a rate of 182 per 100,000 nationally. The CDC last season also reported the highest number of flu-related deaths among children in a non-pandemic season -- 169 -- and an estimated 381,000 U.S. hospitalizations from the flu.

A new report released by the CDC earlier this month highlighted the benefits of getting a flu vaccine. According to the report's estimates, the vaccine prevented 6.6 million illnesses and 79,000 hospitalizations last season.

Schlievert said he would like to see the new staph-related vaccination given in addition to the seasonal flu vaccine.

Working with Schlievert on the project are UI researchers Adam Spaulding, Wilmara Salgado-Pabon, Joseph Merriman, and Christopher Stach, along with University of Minnesota researchers Yinduo Ji, Aaron Gillman, and Marnie Peterson, according to UI News Services. ___

Copyright 2013 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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BioPen to rewrite orthopaedic implants surgery

media.uow.edu.au

Dec 4th 2013 8:13 PM

A handheld ‘bio pen’ developed in the labs of the University of Wollongong (UOW) will allow surgeons to design customised implants on-site and at the time of surgery.

The BioPen, developed by researchers from the UOW-headquartered Australian Research Council Centre of Excellence for Electromaterials Science (ACES), will give surgeons greater control over where the materials are deposited while also reducing the time the patient is in surgery by delivering live cells and growth factors directly to the site of injury, accelerating the regeneration of functional bone and cartilage.

The BioPen works similar to 3D printing methods by delivering cell material inside a biopolymer such as alginate, a seaweed extract, protected by a second, outer layer of gel material. The two layers of gel are combined in the pen head as it is extruded onto the bone surface and the surgeon ‘draws’ with the ink to fill in the damaged bone section.

A low powered ultra-violet light source is fixed to the device that solidifies the inks during dispensing, providing protection for the embedded cells while they are built up layer-by-layer to construct a 3D scaffold in the wound site.

Once the cells are ‘drawn’ onto the surgery site they will multiply, become differentiated into nerve cells, muscle cells or bone cells and will eventually turn from individual cells into a thriving community of cells in the form of a functioning a tissue, such as nerves, or a muscle.

The device can also be seeded with growth factors or other drugs to assist regrowth and recovery, while the hand-held design allows for precision in theatre and ease of transportation.

The BioPen prototype was designed and built using the 3D printing equipment in the labs at the University of Wollongong and was this week handed over to clinical partners at St Vincent’s Hospital Melbourne, led by Professor Peter Choong, who will work on optimising the cell material for use in clinical trials.

The BioPen will help build on recent work by ACES researchers where they were able to grow new knee cartilage from stem cells on 3D-printed scaffolds to treat cancers, osteoarthritis and traumatic injury.

Professor Peter Choong, Director of Orthopaedics at St Vincent’s Hospital Melbourne and the Sir Hugh Devine Professor of Surgery, University of Melbourne said:

“This type of treatment may be suitable for repairing acutely damaged bone and cartilage, for example from sporting or motor vehicle injuries. Professor Wallace’s research team brings together the science of stem cells and polymer chemistry to help surgeons design and personalise solutions for reconstructing bone and joint defects in real time.”

The BioPen will be transferred to St Vincent’s for clinical projects to be carried out at the proposed Aikenhead Centre for Medical Discovery in Melbourne.

“The combination of materials science and next-generation fabrication technology is creating opportunities that can only be executed through effective collaborations such as this,” ACES Director Professor Gordon Wallace said.

“What’s more, advances in 3D printing are enabling further hardware innovations in a rapid manner.”

Design expertise and fabrication of the BioPen was supported by the Materials Node of the Australian National Fabrication Facility, hosted at the University of Wollongong’s Innovation Campus.

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Tongue Driven Wheelchair

news.gatech.edu

Clinical Trial Shows Tongue-Controlled Wheelchair Outperforms Popular Wheelchair Navigation System

After a diving accident left Jason DiSanto paralyzed from the neck down in 2009, he had to learn how to navigate life from a powered wheelchair, which he controls with a sip-and-puff system. Users sip or puff air into a straw mounted on their wheelchair to execute four basic commands that drive the chair. But results from a new clinical study offer hope that sip-and-puff users like DiSanto could gain a higher level of independence than offered by this common assistive technology.

In the study, individuals with paralysis were able to use a tongue-controlled technology to access computers and execute commands for their wheelchairs at speeds that were significantly faster than those recorded in sip-and-puff wheelchairs, but with equal accuracy. This study is the first to show that the wireless and wearable Tongue Drive System outperforms sip-and-puff in controlling wheelchairs. Sip-and-puff is the most popular assistive technology for controlling a wheelchair.

The Tongue Drive System is controlled by the position of the user’s tongue. A magnetic tongue stud lets them use their tongue as a joystick to drive the wheelchair. Sensors in the tongue stud relay the tongue’s position to a headset, which then executes up to six commands based on the tongue position.

The Tongue Drive System holds promise for patients who have lost the use of their arms and legs, a condition known as tetraplegia or quadriplegia.

“It’s really easy to understand what the Tongue Drive System can do and what it is good for,” said Maysam Ghovanloo, an associate professor in the School of Electrical and Computer Engineering at the Georgia Institute of Technology, and a study co-author and principal investigator. “Now, we have solid proof that people with disabilities can potentially benefit from it.”

The study was published on Nov. 27 in the journal Science Translational Medicine. The National Institute of Biomedical Imaging and Bioengineering and the National Science Foundation funded the research. Scientists from Shepherd Center in Atlanta, and the Rehabilitation Institute of Chicago and the Northwestern University Feinberg School of Medicine in Chicago were also involved in the study. Jeonghee Kim and Hangue Park, who are working on the Tongue Drive System as graduate students at Georgia Tech, are co-authors of the study.

“The Tongue Drive System is a novel technology that empowers people with disability to achieve maximum independence at home and in the community by enabling them to drive a power wheelchair and control their environment in a smoother and more intuitive way,” said Northwestern co-lead investigator Elliot Roth, M.D, chair of physical medicine and rehabilitation at Feinberg and the medical director of the patient recovery unit at Rehabilitation Institute of Chicago. “The opportunity to use this high-tech innovation to improve the quality of life among people with mobility limitations is very exciting.”

The research team had subjects complete a set of tasks commonly used in similar clinical trials. Subjects in the trials were either able-bodied or people with tetraplegia.

“By the end of the trials, everybody preferred the Tongue Drive System over their current assistive technology,” said Joy Bruce, manager of Shepherd Center’s Spinal Cord Injury Lab and co-author of the study. “It allows them to engage their environment in a way that is otherwise not possible for them.”

Researchers compared how able-bodied subjects were able to execute commands either with the Tongue Drive System or with a keypad and mouse. For example, targets randomly appeared on a computer screen and the subjects had to move the cursor to click on the target. Scientists are able to calculate how much information is transferred from a person’s brain to the computer as they perform a point-and-click task. The performance gap narrowed throughout the trial between the keypad and mouse and the Tongue Drive System.

For the first time, the research team showed that people with tetraplegia can maneuver a wheelchair better with the Tongue Drive System than with the sip-and-puff system. On average, the performance of 11 subjects with tetraplegia using the Tongue Drive System was three times faster than their performance with the sip-and-puff system, but with the same level of accuracy, even though more than half of the patients had years of daily experience with sip-and-puff technology.

“That was a very exciting finding,” Ghovanloo said. “It attests to how quickly and accurately you can move your tongue.”

The idea for piercing the tongue with the magnet was the inspiration of Anne Laumann, M.D., professor of dermatology at Feinberg and a lead investigator of the Northwestern trial. She had read about an early stage of Tongue Drive System using a glued-on tongue magnet. The problem was the magnet fell off after a few hours and aspiration of the loose magnet was a real danger to these users.

“Tongue piercing put to medical use — who would have thought it? It is needed and it works!” Laumann said.

The experiments were repeated over five weeks for the able-bodied test group, and over six weeks for the tetraplegic group. All of the subjects with tetraplegia were able to complete the trial, which Ghovanloo called an “exciting” and “major finding.”

The tetraplegic group was using the Tongue Drive System just one day each week, but their improvement in performance was dramatic.

“We saw a huge, very significant improvement in their performance from session one to session two,” Ghovanloo said. “That’s an indicator of how quickly people learn this.”

Experiments on the Tongue Drive System to date have been done in the lab or hospital. In future studies, scientists will test how the Tongue Drive System performs outside of the controlled clinical environment. The research team hopes to test how patients maneuver with the Tongue Drive System in their homes and other environments.

The Tongue Drive System isn’t quite ready for commercialization, but Ghovanloo’s startup company, Bionic Sciences, is working with Georgia Tech to move the technology forward.

Ghovanloo is the foundering director of the GT-Bionics Laboratory, where his team is experimenting with other devices to improve the quality of life for individuals with disability.

“All of my projects are related to helping people with disabilities using the latest and greatest technologies,” Ghovanloo said. “That’s my goal in my professional life.”

DiSanto hopes that the one day he’ll be able to use a tongue-powered wheelchair outside of the hospital, which would help him gain some independence he lost after his diving accident.

"The Tongue Drive System will greatly increase my quality of life when I can start using it everywhere I go,” DiSanto said. “With the sip-and-puff system, there is always a straw in front of my face. With the Tongue Drive, people can see you, not just your adaptive equipment."

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World’s smallest pacemaker can be implanted without surgery

Heart disease health news:

December 13, 2013 12:00 am by Staff

Pacemaker surgery typically requires a doctor to make an incision above a patient’s heart, dig a cavity into which they can implant the heartbeat-regulating device, and then connect the pulse generator to wires delivered through a vein near the collarbone. Such surgery could soon be completely unnecessary. Instead, doctors could employ miniaturized wireless pacemakers that can be delivered into the heart through a major vein in the thigh

On Monday, doctors in Austria implanted one such device into a patient—the first participant in a human trial of what device-manufacturer Medtronic says is the smallest pacemaker in the world. The device is 24 millimeters long and 0.75 cubic centimeters in volume—a tenth the size of a conventional pacemaker. Earlier this year, another device manufacturer, St. Jude Medical, bought a startup called Nanostim that makes another tiny pacemaker, and St. Jude is offering it to patients in Europe. This device is 41 millimeters long and one cubic centimeter in volume.

Doctors can implant such pacemakers into the heart through blood vessels, via an incision in the thigh. They use steerable, flexible tubes called catheters to push the pacemakers through a large vein.

The two new devices are the latest effort to make heart surgery less traumatic. Doctors began to widely use less invasive heart treatments in the late 1990s, when artery-unclogging balloons delivered by catheters started to replace bypass surgeries. Other cardiac technologies like stents, which prop open weak or narrow arteries, can also be delivered through blood vessels. More recently, researchers have developed artificial valves for patients whose natural valves have become damaged; these devices can also be delivered by catheters snaking through large blood vessels.

Brian Lindman, a cardiovascular specialist at Washington University School of Medicine, and colleagues have found that less invasive catheter-based procedures for valve repair can be safer for high-risk elderly patients and can enable doctors to treat patients who are too frail to undergo surgery. More recently, Lindman published a study suggesting that the transcatheter method may improve the odds of survival for diabetic patients as well. However, for some cardiac treatments such as valve repair, a more invasive surgery enables longer-lasting repairs, and so may be the better option for patients strong enough for surgery. “Surgery or transcatheter is not always better,” says Lindman. “It depends on the cardiac problem and on the nuances of each procedure.”

Both tiny pacemakers are now being tested in human trials, and St. Jude’s has been approved for use in patients in Europe. The device manufacturers say the batteries in the tiny pacemakers will last up to eight or 10 years when running at full-stimulating capacity. The new pacemakers are also “leadless”—that is, they don’t require long electrodes winding their way into heart. Instead, they sit inside the heart and deliver electric pulses through small prongs that touch the heart. This new design reduces the amount of power required by the device and eliminates a major source of device failure (see “A Pacemaker the Size of a Tic Tac”).

Medtronic has also developed a miniaturized cardiac monitor for patients with arrhythmias or undiagnosed heart problems. Cardiac monitors continuously track heart activity; patients undergoing testing are may have to wear a portable device around their neck, which hooks up to wires from several electrodes stuck to the chest, perhaps for days at a time. Doctors can implant Medtronic’s new monitor using a syringe-like system that inserts the device into a small incision above the heart that is just eight millimeters deep. The monitor can then wirelessly transmit heartbeat data to a bedside monitor or potentially even to a smart phone, says Mark Phelps, an engineer leading Medtronic’s miniaturization efforts.

View "World’s Smallest Pacemaker Can Be Implanted without Surgery" and find more technology news from MIT Technology Review.

Read more: http://medcitynews.com/2013/12/heart-disease-health-news-worlds-smallest-pacemaker-can-implanted-without-surgery/#ixzz2nOQoPi4W

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Diabetes Data Beamed to Your Phone

 

by Walter S. Mossberg, online.wsj.comDecember 10th 2013 9:04 AM

Home medical devices, as opposed to fitness products like activity-measuring wrist bands, have too often been stuck in the past, even as smartphones have zoomed ahead on hardware and software.

A prime example is the device used by diabetics, a small gadget called a glucometer that analyzes a tiny drop of blood. Diabetics usually use these several times daily to determine the levels of glucose in their blood and make decisions on diet, exercise and medication.

Most glucometers use ancient technology that provides only a snapshot of information. And most lack wireless connections for easily transmitting readings to digital devices for more sophisticated analysis or for sharing the data with a doctor. Many diabetics still log their results using pen and paper.

I've been reviewing two diabetes meters that aim to change that. Both are able to instantly send results to a smartphone over a Bluetooth wireless connection. Each offers an app that collects and analyzes the readings, and gives a picture of how their users are doing over time. Both apps can also send reports from the phone to a doctor or other person.

One is the iHealth Wireless Smart Gluco-Monitoring System, and comes from a company of the same name that also makes other products that aim to provide a collection of digital sensors for health measurement. It's more of a tech company than a standard medical-device company.

The other is the OneTouch VerioSync Meter and comes from LifeScan Inc., a Johnson & Johnson JNJ -0.66%company that is a leader in the glucose-monitoring business.

I've been testing both products for a few days, and both work as advertised. Both are FDA approved, though they operate a bit differently, and their companion apps are different.

The iHealth meter is available now, while the LifeScan product is set to come out early next year.

One caveat: These two new meters are only partial steps toward improving diabetes care. Users will still need to prick their fingers multiple times daily to get those drops of blood. And both use disposable test strips, which can cost $1 or more apiece, before insurance.I can recommend either for diabetics who'd like to know more at a glance, and tie their most important health-tracking device into their sophisticated phones.

The VerioSync looks like a traditional meter. It's a rectangular white plastic device with a large, black inset screen that presents the glucose reading in large white type. The iHealth device is designed to look much cooler. It's a slender, curvy white device with a blank white surface on which the reading appears in fainter blue type.

LifeScan's new meter works only with Apple's AAPL -0.36% iOS devices—iPhones, iPads and iPod Touches. It's expected to cost $20 at launch, and $30 thereafter. A box of 25 test strips is expected to cost $40, before insurance.

The iHealth meter works with both Apple's devices and seven Android phones. It costs $80 for a kit that includes the device, 50 strips, and other accessories. More strips cost $50 for a packet of 50, before insurance.

As with any Bluetooth device, like a headset, you have to pair these meters with your phone. I found this easier with the VerioSync. In addition, the VerioSync more easily reconnected with the phone whenever it was in range and I prepared to do a test. The iHealth app always asked me to press a button on the meter to reconnect.

Both meters can be used when out of range of the smartphone to which they are paired. In these cases, the meters save the readings, and then sync them to the phone the next time you're in range. You can also use the free apps without buying the meters, as digital logbooks. But the companies say their apps only sync data wirelessly from their own meters.

Traditional meters use small batteries that can last months. A downside of these two Bluetooth meters is that they don't use removable batteries and must be recharged periodically. The meter can last three to four weeks on a charge for a person who tests three times daily, iHealth says. LifeScan says its meter lasts up to two weeks between charges.

I found the LifeScan VerioSync app to be richer and easier to understand. At a glance, it shows you a color-coded bar that tells you what percentages of the time you've been in or out of your optimal range of glucose readings for the last 14 days. You can also see your average reading, and other data, quickly. Tapping on these symbols gives more details.

There's also a logbook that shows readings, and patterns of readings, over 14 days, or grouped by time of day. You can manually add readings from other meters, and customize your target ranges, presumably according to what your doctor recommends. You can also email screenshots, or even tables, of results.

The iHealth app is plainer, and more table-based, though it does include a simple graph to show trends. It also lets you manually enter readings and set target ranges. And it allows you to email results, in table or graphic form, or even post them to social networks. One nice addition: iHealth's emails include a file that can be opened in a spreadsheet.

A big difference is that, when you are in Bluetooth range, the iHealth app walks you through the test-taking process on the screen of the phone, which I believe could be annoying to an experienced tester. Even in range, the VerioSync app merely receives and integrates the reading.

With iHealth, you also get access to a browser-based cloud dashboard that collects data from all of the company's devices you might own. But I found the glucose portion of this to be pretty rudimentary. And you can still only share results via email, not by giving others permission to access to your cloud account.

Either of these meters could make disease management easier for diabetics with smartphones. But the snail's pace of improvement in these devices is maddening.

Write to Walter S. Mossberg at walt.mossberg@wsj.com

 

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This is really cool

http://medcitynews.com/2013/12/adorable-12-year-old-boy-terrify-device-makers/?utm_source=MedCity+News+Subscribers&utm_campaign=d72c7069bc-RSS_Daily+Top+Stories&utm_medium=email&utm_term=0_c05cce483a-d72c7069bc-67646345

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Baseball cap can help in overcoming hearing loss

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Breathe easy. Simple breath tests could reveal clues about cancer, heart failure, diabetes

by Deanna Pogorelc, medcitynews.com

October 30th 2013 10:53 AM

The breathalyzer test isn’t just for drunk drivers. In medicine, breath tests are used to screen for h. pylori, lactose intolerance and whether asthma medications are working, to name a few.

Because the breath contains over a thousand compounds at trace levels, it’s also become an appealing target for non-invasive tests that would help doctors detect and diagnose disease.

There are some barriers to breath-based biomarkers, namely the need for expensive technology used to analyze the presence and concentration of those chemicals. While much of the following research is early, it sheds light on the possibilities being explored for new non-invasive diagnostics.

Cancer

Researchers at the Cleveland Clinic recently presented research on a breath biomarker for lung cancer. A test they’re developing uses a chemical sensor called a colorimetric sensor array that picks up on a unique chemical signature released by cancer cells as tumors grow.

A small clinical trial last year by Italian researchers also suggested that certain exhaled volatile organic compounds may be red flags for colon cancer.

Heart failure

Cleveland Clinic researchers have also identified VOCs that correlate with the presence of cardiovascular disease. In a study published earlier this year in the Journal of the American College of Cardiology, they collected breath samples from 77 patients and used mass spectrometry to look for those compounds. The researchers reported that the technique identified all of the patients who experienced heart failure. The question is — would it be able to do so early enough to make a difference in outcomes?

Diabetes

A few different groups are working on detecting a chemical called acetone in the breath that increases when the body is deficient of glucose. A team at the University of Pittsburgh was working this summer on prototyping a sensor. Another group in Canada is putting together a semiconductor sensor. Oxford Medical Diagnostics has tested methods of measuring acetone through the breath but has not released any news recently.

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this-robot-is-changing-how-we-cure-diseases

 

 

http://live.wsj.com/video/this-robot-is-changing-how-we-cure-diseases/C44DAE3D-C7FD-4C87-9E3F-685498A0C2CB.html?mod=djemMostPopVideo_h#!C44DAE3D-C7FD-4C87-9E3F-685498A0C2CB

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Panel Unveils Shakeup in Strategy to Cut Heart Risk

by Ron Winslow, online.wsj.com

November 12th 2013 4:01 AM

The long-standing strategy of reducing heart-attack risk by lowering cholesterol to specific targets is being jettisoned under new clinical guidelines unveiled Tuesday that mark the biggest shift in cardiovascular- disease prevention in nearly three decades.

Gone is the familiar and easy-to-understand guidance to keep LDL, or bad cholesterol, below 100 or below 70 for people at high risk—a mainstay of current prevention policy. Instead, doctors are being told to assess a patient's risk more broadly and prescribe cholesterol-lowering statin drugs to those falling within one of four risk categories.

The aim is to more effectively direct statin treatment to patients with the most to gain, and move away from relatively arbitrary treatment targets that are less reliable in predicting risk than is widely believed.

"We're trying to focus the most appropriate therapy to prevent heart attack and stroke ... in a wide range of patients," said Neil J. Stone, professor of medicine at Northwestern University Feinberg School of Medicine and head of the expert panel that wrote the cholesterol guidelines.

Cardiovascular disease is the Western world's leading killer. In the U.S., heart disease accounts for about 600,000 deaths each year, or about one in four deaths. About 130,000 people in the U.S. die each year of stroke, which is also a major cause of disability.

Numerous studies show that statins, which are among the most prescribed drugs in the world, reduce the risk of heart attack and stroke. But solid data demonstrating the benefit of reaching specific targets are lacking, said Dr. Stone.

While lowering LDL remains a critical goal, the focus is on the risk reduction achieved with statins rather than the effect on LDL, said Donald Lloyd-Jones, chief of preventive medicine at Northwestern and a member of the guidelines panel.

Cardiologists expect the recommendations, jointly developed by the American College of Cardiology and the American Heart Association, to substantially change the conversation between doctors and tens of millions of patients over the best way to lower their risk of a heart attack or stroke.

The risk groups identified in the guidelines include patients who have already had a heart attack, stroke or major symptoms of cardiovascular disease; those with an LDL of 190 or higher, which typically has a genetic cause; people with diabetes; and anyone ages 40 to 79 who faces a 7.5% risk of having a heart attack over the next 10 years, according to a new risk score. That score—with a lower threshold than under current guidelines—takes into account cholesterol level, smoking status, blood pressure and other factors.

All are recommended to take high or moderate statin doses that would results in LDL reductions of about 30% to more than 50%.

If fully implemented, the guidelines could more than double the number of Americans who qualify for statin therapy, to more than 30 million, the authors estimated.

The new approach is likely to have a modest immediate effect on the pharmaceutical industry. All but one of the statins available, including Lipitor, have lost patent protection and are available as inexpensive generics.

AstraZeneca AZN.LN -0.23% PLC's Crestor, the one remaining branded statin and the most powerful on the market, could get a boost from the recommendations. Merck MRK +1.30% & Co.'s Zetia, a non-statin cholesterol-reducer that is also an ingredient in Vytorin, could take a hit because the guidelines discourage use of agents that haven't been proven to reduce risk of bad events. Zetia hasn't been shown to reduce bad events even though it lowers LDL.

But both supporters and critics of the new guidelines worry they will confuse patients and physicians, and potentially disrupt an easy-to-understand and successful strategy. While statins haven't been the only factor, research shows there has been a significant reduction in heart attacks and death from cardiovascular disease in the past two decades since the drugs were introduced.

"This is a tension between the practical and the scientific," said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. Having targets for LDL "gives doctors and patients something to shoot for" as well as a motivation to try to get there, Dr. Nissen said. "The elimination of target levels is going to be a huge change for physicians and patients."

Write to Ron Winslow at ron.winslow@wsj.com

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What is an inhaler?

by Rick Frea, respiratorytherapycave.blogspot.com

October 15th 2013

The following was originally published on 11/21/11 at healthcentral.com/asthma: "What is an inhaler?"

To put it bluntly, inhalers are a gift to people with lung diseases from God. It's asthma medicine made easy.

Albuterol inhaler

The first inhaler was invented in 1956. It was a godsend because now asthmatics could carry with them in their pockets or purses their asthma rescue medicine.

They now had quick and easy access to their asthma medicine anywhere, any time, and any place.

While the medicine has changed over the years, the basic inhaler design is still the same.

The key to this invention was the actuator with a one-way valve that allowed for the medicine and propellant to be sprayed in a uniform dose (a metered dose), and soon became known as the metered dose inhaler (MDI). In some countries it's called an atomizer or a puffer.

Today there are many medicines delivered by inhaler, and the inhaler market is one of the most profitable products in the pharmaceutical industry. The Albuterol inhaler is the most commonly prescribed and most profitable asthma medicine of all time.

The neat thing about the inhaler is it allows for medicine to make it to the lungs for quick action. Likewise, since the medicine goes directly to the lungs, this eliminates many systemic side effects of the medicine.

You can stick the mouthpiece of the inhaler into your mouth and squirt. The medicine will still work, but you will notice that most of the medicine hits the back of your oral airway. When this happens, most of the medicine is wasted.

So scientists have discovered better, more efficient ways of using an inhaler.

One way is to place the mouthpiece two finger lengths away from your mouth. You shake the inhaler well, then hold it two finger lengths from your mouth. As you start to inhale you squirt the inhaler. Take in as deep a breath as you can and hold your breath 5-10 seconds.

However, you want to make sure your breath is slow and easy. If you breathe in too fast this will cause turbulance that will cause the medicine to land in your mouth before it gets deep into your lungs. You want a slow, laminar flow.

This makes sure the more of the medicine is distributed in your air passages where it can work.

The ideal way of using an inhaler, however, is to use a spacer device. Spacers help you with coordination, and it also breaks apart the large particles so what you are inhaling are smaller particles that go directly into your air passages.

Studies show spacers make the medicine work 75 percent better and with fewer side effects.

When I was a kid it was recommended that if you didn't want to pay for a spacer you use a toilet paper roll for this purpose. While it's a crude design, it makes the medicine work better.

The principle of using an inhaler with a spacer is similar to the two finger technique, yet instead of space between your mouth and the inhaler there is a spacer. You shake up the inhaler well, place the inhaler into one end of the spacer and your mouth on the spacer mouthpiece. You squirt as you start to inhale, take in a deep breath, and hold for 5-10 seconds. Do not remove your mouth from the mouthpiece until you are done holding your breath.

There are many different kinds of spacers, yet my favorite is the AeroChamber as seen in the picture. This device will alarm if you inhale too fast, so the spacer actually coaches you how to inhale nice and smooth-like.

Another neat thing about the aerochamber is it allows you to squirt the medicine even before you put the spacer in your mouth. This works well for children or elderly people who have trouble with inhaler coordination.

For smaller kids you can also place a mask on the mouthpiece end, and this helps an adult hold the mask over the child's face to facilitate coordination.

Many studies show that using an inhaler with a spacer results in better medicine distribution than nebulized medicine. This is especially true with young kids.

I like to tell my patients to make sure your mouth stays on the spacer mouthpiece until you are done holding your breath. This assures none of the medicine is wasted.

Regardless of what technique you use, you should take one puff and then wait 2-5 minutes to take a second puff. When using your rescue inhaler, the first puff will open up your air passages and the second will do the mop up job.

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Biotech uses bacteria known for food poisoning to treat cancer, immune disorders

by Sandra Lobo, medcitynews.com

November 4th 2013 7:42 AM

Stephen T. Isaacs

Traditional approaches to for cancer are quite limited in treating late-stage and aggressive cancers. Aduro BioTech, Inc., a clinical-stage immunotherapy company, is using the immune system to fight cancer and provide more options for patients. The immune system defends against the growth and spread of tumors. Cancer develops as a result of multiple changes in the cellular machinery that inhibits this line of defense, thereby allowing the tumor to grow. Once this occurs, a successful treatment could be vaccines that induce a broad and potent immune response to break the immune system’s tolerance of the tumor. Aduro has developed such vaccines, using three complementary immunotherapy platforms, Listeria, GVAX and cyclic dinucleotides (CDNs), with broad applications in cancer and infectious disease.

The Listeria platform uses a live, attenuated strain of Listeria monocytogenes to treat cancer and infectious diseases. The strain is engineered to deliver cancer or microbial antigens into cells to be processed by the host cellular machinery and presented to the immune system, thus inducing a potent immune response. The use of this bacteria as a cancer/microbial vaccine platform has several advantages, such as direct targeting of immune (dendritic) cells, signaling the innate immune system through multiple pathways and an ability to be repeatedly administered without being neutralized.

Using a pathogen such as Listeria to treat disease may seem counter-intuitive, but Aduro’s Listeria platform has been shown to be well tolerated in multiple clinical trials. CRS-207 is Aduro’s lead Listeria -based therapeutic, engineered to express the tumor-associated antigen mesothelin. CRS-207 was evaluated in a Phase 1 trial in 17 end-stage patients with cancers known to express mesothelin: mesothelioma, non-small-cell lung, ovarian and pancreatic. Despite an expected survival of 3-5 months for all subjects treated with CRS-207, six out of 17 lived 15 months or longer.

The GVAX platform utilizes human cancer cell lines that have been genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is a potent cytokine capable of inducing differentiation, proliferation and activation of a variety of immune cells, thus serving as a stimulant for the immune system. The immunostimulatory property of this cytokine has been exploited for use as a vaccine adjuvant to boost the potency of poorly immunogenic cancer antigens as vaccines. The GVAX cell lines have been irradiated to prevent cell division, yet are metabolically active. GVAX products include vaccines for pancreatic cancer, leukemia, myeloma, breast and prostate cancer that are all in the late human clinical stage, with colorectal and melanoma in the early human clinical stage.

Aduro’s strong growth has been led byDr. Stephen T. Isaacs, president and CEO of Aduro BioTech, who initiated the current immunotherapy program. Issacs recruited key members of the current vaccine team with deep expertise in the biology of Listeria. Aduro’s business model is based on leveraging platform technologies to rapidly develop and advance a broad range of new vaccines and vaccine combinations for applications in oncology, infectious diseases and biodefense. Aduro’s future pipeline includes a new Listeria -based therapeutic, ADU-623, that is expected to be advanced in 2013 into an investigator-sponsored Phase 1 clinical trial in patients with glioblastoma. In addition, the company continues to be funded by research grants for the development of new vaccines for prostate cancer, tularemia, hepatitis B virus (HBV) and melanoma.

Isaacs said with three complementary platforms in addition to the Listeria platform, his company is in a good spot to take advantage of the new approach to cancer treatment.

“We are entering the new era of immunotherapy, and what is becoming clear is that combinations are more effective than individual immunotherapies that only activate one part of the immune system,” he said.

Aduro acquired all GVAX assets from BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), including intellectual property and cell lines. Under its purchase agreement with BioSante, Aduro paid $1 million upfront and has committed to additional milestone and royalty payments after commercialization of GVAX products.

Four GVAX vaccines have been granted U.S. Food and Drug Administration Orphan Drug designation: GVAX Pancreas for the treatment of pancreatic cancer, GVAX AML for the treatment of acute myeloid leukemia, GVAX CML for the treatment of chronic myeloid leukemia and GVAX Melanoma for the treatment of melanoma. Aduro is currently evaluating the sequential administration of the GVAX Pancreas vaccine and its own Listeria -based CRS-207 in a randomized, controlled Phase 2 trial of 90 patients with metastatic pancreatic cancer, and enrollment in the trial has been completed. The company presented abstracts at both ASCO and ESMO, but have not posted the information on its our website yes due to an embargo.

The CDNs platform uses cyclic dinucleotides that are ubiquitous molecules secreted by Listeria and other intracellular pathogens. These molecules signal through STING (STimulator of INterferon Genes), inducing the expression of inflammatory cytokines that are known to induce a potent innate immune response. A principal barrier to the development of effective vaccines is the lack of adjuvants and formulations that can elicit an effective and long-lived immune response. Aduro’s CDNs represent a new class of adjuvants that have been shown to effectively increase vaccine potency. Aduro is now combining CDNs with GVAX into a new vaccine named STINGVAX that has demonstrated superior efficacy over GVAX alone in animal models.

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Bristol-Myers, Merck and Roche Develop Drugs to Zap Tumors Via Immune System

October 14, 2013 7:25 PM

By

RON WINSLOW and

PETER LOFTUS at the Wall Street Journal

As genetically targeted therapies gain ground against cancer, another treatment strategy called immunotherapy is emerging as a potentially powerful new partner against malignancies.

At least five major drug companies, including Bristol-Myers Squibb Co., Merck & Co. and Roche Holding AG, are developing drugs known as immune checkpoint inhibitors that work by unleashing the body's immune system to enable it to recognize and attack tumor cells. Small biotechnology companies are also embracing the approach.

While one such agent, Bristol-Myers' Yervoy, is already on the market for melanoma, recent small studies suggest the strategy has promise against lung and kidney tumors and possibly such cancers as ovarian, head and neck and colon.

Meantime, a pooled analysis of 1,800 advanced melanoma patients treated with Yervoy showed late last month that 22% were alive three years later—most after a single 12-week course of therapy.

Such a durable stifling of malignancy in a significant number of patients with advanced disease is almost unheard of in cancer, and it is triggering palpable excitement across the world of oncology.

"That these agents can produce a long-term stable response in multiple tumor types is a whole new approach to treating cancer," said Roy Herbst, chief of medical oncology at Yale Cancer Center, New Haven, Conn.

Wall Street is enthusiastic as well. Leerink Swann analysts told investors recently that half of all cancer treatments could involve immunotherapy agents within the next 10 years, not only transforming treatment but boosting the fortunes of several companies testing candidate drugs in clinical trials.

Some analysts believe the market for such agents could ultimately exceed $10 billion.

Unlike genetically targeted drugs, which disrupt mutations that fuel tumor growth, the new agents treat the immune system.

Most of the interest is focused on drugs that target a molecular pathway known as PD-1, for programmed death receptor 1, which acts as a brake on the immune system to prevent it from attacking healthy cells.

Cancer cells can exploit the mechanism by latching on and using PD-1 to escape destruction by the body's immune system.

Bristol Myers' experimental PD-1 inhibitor nivolumab and Merck's candidate, MK-3475, block this interaction, allowing the immune system to attack the cancer cells. Yervoy inhibits a similar checkpoint.

Barclays analyst Tony Butler estimates that Bristol's nivolumab could eventually generate annual global sales of $6 billion for its use in lung cancer. He says the potential advance in cancer treatment that such agents represent is similar to Gleevec—a Novartis drug launched in 2001 that vastly improved treatment of a form of leukemia—but the new agents have "potentially much larger market implications" because they have potential to treat multiple tumor types.

Many researchers believe the broadest impact of the drugs will come from combining them with other treatments—including radiation, chemotherapy and targeted agents as well as other checkpoint inhibitors—to mount a more potent attack on the tumor.

Bristol-Myers, regarded as the checkpoint market leader, sees combining two such inhibitors as an important element of its strategy. A study last May found that combining Yervoy and nivolumab achieved better results in melanoma patients than either drug alone.

"Our approach is to use the proof of that paradigm [from melanoma] in lung cancer and other tumor types," said Nils Lonberg, senior vice president, Immuno-Oncology & Biologics Discovery at Bristol-Myers.

Challenges loom. Only a minority of patients respond to the drugs when given as a single agent.

Combining them with other therapies "is trickier than you think," said Charles Drake, a researcher at Johns Hopkins Kimmel Cancer Center, Baltimore. "Sometimes, you give one drug first and then the other; the order is critical," he said, based on results of studies in mice. "Other times it's parallel." How this will pan out in people isn't clear.

Another challenge is cost. Yervoy currently costs about $120,000 for four doses given over 12 weeks. Use in combination with another big-ticket drug could be a big barrier to access. One question, Dr. Drake said, is whether competition to develop such agents will lead to reduced costs.

Meantime, Merck's MK-3475, and a drug from Roche that targets a different part of the PD-1 mechanism, are showing promise in melanoma, lung and other cancers.

Positive findings reported this month for MK-3475 prompted Merck to move that drug into advanced-stage testing for lung cancer, said Eric H. Rubin, vice president, oncology for Merck Research Laboratories.

AstraZeneca and GlaxoSmithKline are also testing PD-1 inhibitors. "It's a race. It's a very competitive environment right now," said Dr. Herbst at Yale, which is involved in several late-stage trials of the approach.

Another contender is Jounce Therapeutics Inc., a Cambridge, Mass., startup founded by James Allison, now an oncologist at MD Anderson Cancer Center, Houston, whose research in the 1990s led to the development of Yervoy. Among other projects, his company is working on a new checkpoint blocker that in animal studies significantly improved the effectiveness of Yervoy, he said.

Write to Ron Winslow at ron.winslow@wsj.com and Peter Loftus at peter.loftus@dowjones.com

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