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