Can coffee cause cancer? Only if it's very hot, say WHO scientists

There is no conclusive evidence that drinking coffee causes cancer, the World Health Organization's cancer agency will say as it downgrades its warning, but it will also say all "very hot" drinks are probably carcinogenic.

The International Agency for Research on Cancer (IARC) had previously rated coffee as "possibly carcinogenic" but has changed its mind. On Wednesday it will say its latest review found "no conclusive evidence for a carcinogenic effect".

At the same time, however, it will say other scientific evidence suggests that drinking anything very hot - around 65 degrees Celsius or above – including water, coffee, tea and other beverages, probably does cause cancer of the oesophagus.

Lyon-based IARC, which last year prompted headlines worldwide by saying processed meat can cause cancer, reached its conclusions after reviewing more than 1,000 scientific studies in humans and animals. There was inadequate evidence for coffee to be classified as either carcinogenic or not carcinogenic.

It had previously put coffee as a "possible carcinogen" in its 2B category alongside chloroform, lead and many other substances.

The U.S. National Coffee Association welcomed the change in IARC's classification as "great news for coffee drinkers".

Source: http://www.cnbc.com

The FDA approved a weight-loss device that sucks food out of your stomach

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Get ready to lose your lunch.

A new device that drains a portion of a person's stomach contents after every meal has just won approval from the U.S. Food and Drug Administration.

The AspireAssist device is intended for obese people at least 22 years of age who have not been able to lose weight through other approaches, excluding surgery. The device was developed by King of Prussia, Pennsylvania-based company Aspire Bariatrics.

The device consists of a pump that attaches to hose surgically implanted in a patient's stomach. The hose is connected to a "disk-shaped port valve" that sits flush against the patient's skin, according to a release from the FDA. About 20 to 30 minutes after a meal, the patient opens the valve and for the next 10 minutes drains about 30 percent of the calories consumed — right into the toilet.

The FDA reviewed results from a clinical trial of 111 people using the device along with "appropriate lifestyle therapy," compared with a 60-person control group who received lifestyle therapy without the device. The AspireAssist group lost an average of 12.1 percent of their body weight after a year, compared with a loss of 3.6 percent of body weight for the control group.

"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy," said Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in the release. "Patients need to be regularly monitored by their health-care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake."

There is, of course, a bevy of possible things that can go wrong while wearing the device. The FDA statement warns of side effects including "occasional indigestion, nausea, vomiting, constipation and diarrhea," as well as side effects from the placement (or removal of the tube, including symptoms ranging from sore throats to bleeding and pneumonia, and irritations or conditions around the valve on the outside of the body.

Reactions to the device have varied from enthusiasm to condemnation. "This is it for me," one patient told ABC News in 2013. But a nutritionist quoted in the same article called the device "an enabling device, not a helping device."

Source: http://www.cnbc.com

Celgene stock edges higher amid $3 billion buyback announcement

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Celgene shares were slightly higher Wednesday after the company authorized a repurchase of up to an additional $3 billion of its common stock.

Shares of Celgene later reversed and ended the day 1 percent lower.

"Celgene now has a total of approximately $5.3 billion available from previous authorizations plus the new authorization," the biopharmaceutical giant said in a release, adding it has funneled approximately $15.2 billion to its shareholders through this open-ended program since 2009. The New Jersey-based company's stock has tumbled 16 percent this year. It fell below $100 Wednesday, closing at $99.98.

CELG year to date



Source: http://www.cnbc.com

States get offer of federal money to boost insurer compliance with Obamacare

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Here's some cash to help health insurers stay on the straight and narrow when it comes to Obamacare.

The Obama administration Wednesday said it would offer state insurance regulators a total of $22 million in funding to use to make sure that health insurers are complying with key consumer protections under the Affordable Care Act.

Those protections include certain minimum essential health benefits that must be offered by health plans, such as preventative services, as well as treatment for mental health conditions and substance use disorder. The money also is supposed to help state insurance regulators.

Wednesday's announcement came a week after a report that found that insurance plans across the United States are not offering necessary services for people suffering from addiction, and that two-thirds of certain key "benchmark" Obamacare plans violate the ACA in that regard. Benchmark plans are ones whose monthly premium rate affect the value of subsidies that most Obamacare customers receive if they buy a plan on a government-run marketplace.

"Our findings reveal that people with addiction may not be receiving effective treatment because insurance plans aren't covering the full range of evidence-based care," said Lindsey Vuolo, associate director of Health Law and Policy at The National Center on Addiction and Substance Abuse and lead author of the report last week.

"For example, our review did not find a single state that covers all of the approved medications used to treat opioid addiction," she said.

On Wednesday, in response to the grant announcement, Vuolo said, "The states are primarily responsible for enforcing the Essential Health Benefits and parity requirements, so it is encouraging to see the federal government providing financial assistance to help the states carry out their obligations."

"This is a good start. We hope it will help correct some of the problems we identified in our review of the 2017 EHB benchmark plans," Vuolo said. "We also hope it will lead to better addiction treatment coverage for patients insured by ACA plans."

In addition to preventative services, mental health and substance abuse disorders, the ACA requires health plans to cover ambulatory patient services, emergency services, hospitalization, maternity and newborn care, prescription drugs, rehabilitative services, lab services and pediatric services.

The grant announcement comes as insurers continue filing their proposed rates for Obamacare plans for 2017 with state regulators. Many of those plans are subject to rate review from regulators, who can either negotiate with insurers over adjusting their rates downward or upward from their initial proposals, or can decide the final rates on their own.

The federal Centers for Medicare and Medicaid Services, which announced the additional grants, said they are "part of the $250 million in state rate review grants the Affordable Care Act provided to improve the process for how states review proposed health insurance rate increases and hold insurance companies accountable for unjustified hikes."

The $22 million is rate review money that went unobligated in prior years.

Kevin Counihan, CEO of the federal Obamacare marketplace HealthCare.gov, said the grants "will continue our partnership with states to help support their efforts to enforce consumer protections guaranteed by the Affordable Care Act."

CMS said Wednesday's announcement is the second of three planned this month about efforts to work with insurers and regulators, increase outreach to potential Obamacare customers and strengthen the so-called risk pool of customers enrolled in ACA plans. A strong risk pool is one in which the benefits paid out to sicker enrollees are more than balanced out by the premiums paid into the plan by all customers, so that the plans are not running at a financial loss.

A number of Obamacare insurers have said they are losing money on the plans because their risk pools are sicker than they had anticipated when they set prices for previous years. Those losses have in turn led many insurers to request double-digit percentage rate hikes for premiums in 2017.

Last week, federal health regulators said they wanted to significantly curb the use of short-term health insurance that is not compliant with ACA standards, a move that could drive healthy customers of such plans into Obamacare coverage. Another move regulators are making to strengthen the risk pool is to implement tighter rules on people enrolling in Obamacare plans outside of the narrow open-enrollment window, and helping people who are turning 65 transition into the federal Medicare health coverage program.

Source: http://www.cnbc.com

Clinicians implant world's smallest pacemaker

Jersey Shore University Medical Center, part of Meridian CardioVascular Network, is the first hospital in New Jersey to implant the Micra® Transcatheter Pacing System (TPS) -- the world's smallest pacemaker -- since the device gained U.S. Food and Drug Administration (FDA) approval in April 2016. Micra TPS is a new type of heart device that treats patients with bradycardia, a common heart condition characterized by a slow or irregular heart rhythm.

Procedures with the advanced pacing technology were performed at Jersey Shore by electrophysiologists Edmund Karam, M.D. and Mark Mascarenhas, M.D. to treat multiple patients with bradycardia. People with bradycardia usually experience fewer than 60 beats per minute. At this rate, the heart is unable to pump enough oxygen-rich blood to the body during normal activity or exercise, causing dizziness, fatigue, shortness of breath or fainting spells. Pacemakers are the most common way to treat bradycardia to help restore the heart's normal rhythm and relieve symptoms by sending electrical impulses to the heart to increase the heart rate.

At one-tenth the size of a traditional pacemaker, Micra TPS is the only leadless pacemaker approved for use in the U.S. The minimally-invasive procedure takes less than an hour, and unlike traditional pacemakers -- is not visible.

Comparable in size to a large vitamin, the device does not require cardiac wires (leads) or a surgical "pocket" under the skin to deliver a pacing therapy. Instead, the device is small enough to be delivered through a catheter and implanted directly into the heart with small tines, providing a safe alternative to conventional pacemakers. It also automatically adjusts pacing therapy based on a patient's activity levels. For patients who need more than one heart device, the device has a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction.

"Our Electrophysiology Lab at Jersey Shore is at the forefront of providing the most innovative care for the treatment of heart arrhythmias and related conditions. That we are the first hospital in the state to implant the world's smallest pacemaker since gaining FDA approval reflects our commitment to providing the community with the latest cardiovascular breakthroughs," says Richard M. Neibart, M.D., medical director of Meridian CardioVascular Network.

Source: https://www.sciencedaily.com

1315 Capital closes on $200 million inaugural fund for niche markets

Kids who play with letter and number puzzles for fun grow up to start venture capital firms with alphanumeric names. At least, that was the case for Adele Oliva, partner of 1315 Capital LLC, which just closed a $200 million inaugural fund. The Philadelphia-based firm invests in commercial-stage companies in the medical technology, specialty pharmaceutical and health care services sectors.

Oliva, who led the fund along with co-founder Michael Koby, Oliva told Medical Device Daily that she was indeed a kid who enjoyed matching numbers to their corresponding letter (based on alphabetical position), a method that inspired the naming of 1315 Capital.

Choosing an alphanumeric name is a good strategy for a VC firm, she explained, because VC directories are often in alphabetical order, with numerical names at the top. And that's important because entrepreneurs tend to use those directories when they begin their search for capital.

As for how Oliva and Koby landed on the number 1315, she said it is derived from the numbers that correspond with each of their initials, beginning with 13 representing Koby's first initial, "M", followed by Oliva's last initial, represented by 15. "It was just something unique, hopefully something very endearing, that will go beyond us, the founders," Oliva said. While 1315 may be the new kid on the VC block, the partners have built an operating team of industry veterans with many of their resumes boasting of experience both on the investment and the company management side of med-tech and pharma.

Names of other investors that participated in the fund were not disclosed but 1315 Capital said it included endowments, foundations, state and corporate pension funds and family offices.

Oliva said consolidation in the health care industry has provided opportunities for innovation, particularly in niche markets. Those happen to be the markets that tend to fly under the radar of most larger strategic VC firms, which is why Oliva said 1315 wants to focus its resources on those smaller companies.

An example of that, she said, is the firm's med-tech company, Onkos Surgical, founded last year to act as 1315's commercial engine in the very niche space of ortho-oncology.

"We partnered with a larger 3-D printing company to innovate in that market, which is a very different market [from the traditional knees and hips ortho sector]," Oliva said, adding that a lot of the patients in need of oncology orthopedic devices are pediatric patients.

Onkos Surgical's products are designed to leverage 3-D printing technology, provided through its partnership with Microport, to make devices that mimic the weight and anatomy of the patient's bone.

More than a name

By so strategically (and numerically) representing Oliva and Koby's partnership, the name 1315 also hints at the firm's unique operating partner model. Teams of two executives, who have worked together at multiple companies, are engaged with the investment team and portfolio companies. The founders said they implemented that model with the intention of adding valuable human capital to the investment equation.

"Our unique operating partner model leverages not only the CEO, but also the Chairman, COO and CFO relationships, allowing us to provide a more complete set of skills to help navigate diligence, drive decisions and achieve premium exits," Koby said.

As an example, one of the firm's first three portfolio companies, JDS Therapeutics LLC, is led by a father-son team. Phillip Satow, the company's chairman, and his son Michael Satow, previously founded JDS Pharmaceuticals, which they sold to Noven Pharmaceuticals in 2007.

"We look for highly experienced commercial teams and products in markets where a realitively targeted sales force, usually 40 to 60 reps, can cover the vast majority of the country in a very capital efficient way," Oliva said.

JDS is a specialty pharmaceutical and nutrition company that develops drugs, supplements and food based on bioactive compounds.

Source: http://www.medicaldevicedaily.com

Narrow band imaging can reduce recurrence of bladder tumors

Research into bladder tumor surgery has found that using narrow band imaging can significantly reduce the risk of disease recurrence. The results of the clinical trial, published in European Urology, compared two groups of bladder cancer patients who were due to undergo bladder tumor resection surgery.

Only 5.6% of low-risk patients in the narrow band imaging (NBI) facilitated surgery group experienced a recurrence of bladder tumors in the 12 months following surgery, compared to 27.3% in those who underwent conventional TURBT (trans urethral resection of bladder tumors) surgery.

According to the World Cancer Research Fund, bladder cancer is the ninth most common cancer in the world, with 430,000 new cases diagnosed in 2012.

For patients with early bladder cancer, a specialist will remove the tumors from the bladder lining using a thin telescope called a cystoscope.

The trial, co-ordinated by the Clinical Research Office of the Endourological Society (CROES, Amsterdam), recruited 965 patients from 16 countries to be randomised to either conventional "white light" TURBT or NBI-facilitated bladder tumor surgery.

Mr Richard Bryan, from the University of Birmingham, explained, "Narrow band imaging makes it easier to identify bladder tumors. It can detect small bladder tumors that might otherwise by overlooked by more conventional 'white light' cystoscopy."

Narrow band imaging technology (NBI) was developed by Olympus Medical Systems (Japan) and was first used for bladder cancer patients at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust in 2005.

Mr Bryan continued, "My colleague, Mike Wallace, and I immediately saw the potential of this technology. Now this potential has been confirmed by a large international randomised controlled trial, and the results can only be good news for bladder cancer patients worldwide."

Olympus stated, "We are pleased to see the widespread use of NBI globally, and have been delighted to support this trial in the bladder cancer setting. We will continue to work very closely with urologists to further understand their needs and challenges, and will strive to develop technologies such as NBI that could contribute to improving patient care across the globe."

On behalf of CROES, Professor Jean de la Rosette said, "Conducting a trial of this size across 16 countries has been a great achievement for CROES and the Trial Management Group. We appreciate the time and effort that urologists across the globe have committed to this study, and these results are just the start of the study outputs. We are extremely grateful to Olympus for their support from the outset -- so often such technologies are not robustly assessed in this way, and this represents a breakthrough for urology and CROES."

Source: https://www.sciencedaily.com

Personalized virtual heart predicts the risk of sudden cardiac death

When electrical waves in the heart run amok in a condition called arrhythmia, sudden death can occur. To save the life of a patient at risk, doctors currently implant a small defibrillator to sense the onset of arrhythmia and jolt the heart back to a normal rhythm. But a thorny question remains: How should doctors decide which patients truly need an invasive, costly electrical implant that is not without health risks of its own?

To address this, an interdisciplinary Johns Hopkins University team has developed a non-invasive 3-D virtual heart assessment tool to help doctors determine whether a particular patient faces the highest risk of a life-threatening arrhythmia and would benefit most from a defibrillator implant. In a proof-of-concept study published May 10 in the online journal Nature Communications, the team reported that its new digital approach yielded more accurate predictions than the imprecise blood pumping measurement now used by most physicians.

"Our virtual heart test significantly outperformed several existing clinical metrics in predicting future arrhythmic events," said Natalia Trayanova, the university's inaugural Murray B. Sachs Professor of Biomedical Engineering. "This non-invasive and personalized virtual heart-risk assessment could help prevent sudden cardiac deaths and allow patients who are not at risk to avoid unnecessary defibrillator implantations."

Trayanova, a pioneer in developing personalized imaging-based computer models of the heart, supervised the research and was senior author of the journal article. She holds faculty appointments within Johns Hopkins' Whiting School of Engineering and its School of Medicine, and she is a core faculty member of the university's Institute for Computational Medicine. For this study, she joined forces with cardiologist and co-author Katherine C. Wu, associate professor in the Johns Hopkins School of Medicine, whose research has focused on magnetic resonance imaging approaches to improving cardiovascular risk prediction.

For this landmark study, Trayanova's team formed its predictions by using the distinctive magnetic resonance imaging (MRI) records of patients who had survived a heart attack but were left with damaged cardiac tissue that predisposes the heart to deadly arrhythmias. The research was a blinded study, meaning that the team members did not know until afterward how closely their forecasts matched what happened to the patients in real life. This study involved data from 41 patients who had survived a heart attack and had an ejection fraction--a measure of how much blood is being pumped out of the heart--of less than 35 percent. To protect against future arrhythmias, physicians typically recommend implantable defibrillators for all patients in this range, and all 41 patients in the study received the implants because of their ejection fraction scores. But research has concluded that this score is a flawed measure for predicting which patients face a high risk of sudden cardiac death.

The Johns Hopkins team invented an alternative to these scores by using pre-implant MRI scans of the recipients' hearts to build patient-specific digital replicas of the organs. Using computer-modeling techniques developed in Trayanova's lab, the geometrical replica of each patient's heart was brought to life by incorporating representations of the electrical processes in the cardiac cells and the communication among cells. In some cases, the virtual heart developed an arrhythmia, and in others it did not. The result, a non-invasive way to gauge the risk of sudden cardiac death due to arrhythmia, was dubbed VARP, short for virtual-heart arrhythmia risk predictor. The method allowed the researchers to factor in the geometry of the patient's heart, the way electrical waves move through it and the impact of scar tissue left by the earlier heart attack.

Eventually, the VARP results were compared to the defibrillator recipients' post-implantation records to determine how well the technology predicted which patients would experience the life-threatening arrhythmias that were detected and halted by their implanted devices. Patients who tested positive for arrhythmia risk by VARP were four times more likely to develop arrhythmia than those who tested negative. Furthermore, VARP predicted arrhythmia occurrence in patients four-to-five times better than the ejection fraction and other existing clinical risk predictors, both non-invasive and invasive.

"We demonstrated that VARP is better than any other arrhythmia prediction method that is out there," Trayanova said. "By accurately predicting which patients are at risk of sudden cardiac death, the VARP approach will provide the doctors with a tool to identify those patients who truly need the costly implantable device, and those for whom the device would not provide any life-saving benefits."

Wu agreed that these encouraging early results indicate that the more nuanced VARP technique could be a useful alternative to the one-size-fits-all ejection fraction score.

"This is a ground-breaking proof-of-concept study for several reasons," Wu said, "As cardiologists, we obtain copious amounts of data about patients, particularly high-tech imaging data, but ultimately we use little of that information for individualized care. With the technique used in this study, we were able to create a personalized, highly detailed virtual 3-D heart, based on the patient's specific anatomy. Then, we were able to test the heart virtually to see how irritable it is under certain situations. We could do all this without requiring the patient to undergo an invasive procedure. This represents a safer, more comprehensive and individualized approach to sudden cardiac death risk assessment."

Wu pointed out that an implantable defibrillator also has a few risks of its own and that avoiding implantation of this device when it is not truly needed eliminates these risks. Implantable defibrillators, she said, require invasive access to the heart, frequent device checks and intermittent battery changes. Complications, she added, can include infection, device malfunction and, in rare instances, heart or blood vessel damage.

In addition to eliminating unnecessary device implantations, Trayanova noted that this new risk prediction methodology could also be applied to patients who had prior heart damage, but whose ejection fraction score did not target them for therapy under current clinical recommendations. Thus, Trayanova said, VARP has the potential to save the lives of a much larger number of at-risk patients. With the proof-of-concept study completed, the researchers next hope to conduct further tests involving larger groups of heart patients. The VARP technique is covered by patent protection obtained through the Johns Hopkins Technology Ventures office.

Source: https://www.sciencedaily.com