Boy with kidney disease uses small idea to make a big difference

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(CNN)When a child is in the hospital for an indefinite stay, the one thing that might ease the pain of being there is a toy.

So when 10-year-old Kadin Hoven saw the toy bin at Mattel Children's Hospital UCLA running low, he had an idea.

Kadin was born with non-functioning kidneys. He's already had two kidney transplants. He's currently waiting for a third.

Officially diagnosed with stage 3 renal failure, Kadin has spent a huge portion of his life in the hospital -- specifically, at Mattel. He's had procedures there for many years. While on a visit recently to receive an infusion, he noticed the toy bin was low.

"It made him really sad," Heidi Hoven, Kadin's mother, told CNN.

It gave him the idea to start a toy drive.

"You see a lot of drives, but there aren't a lot of toy drives for children in the hospital," Kadin told CNN.

Hoven, a kindergarten teacher, advertised the drive through her school, friends and family. Donations poured in, in the form of toys and cash. "We had family and friends out of state, people we don't even know, giving us checks," Hoven said.

It took six toy wagons and four volunteers to haul the load -- 281 toys total -- into the hospital Wednesday.

"Their jaws dropped," Hoven said, "They didn't expect to see that many toys."

And there's more, Hoven said. They are delivering another bunch next week.

"It's great to see patients want to give back," Stephanie Talley, a child life specialist at Mattel, told CNN.

The toys were given to the inpatient and pediatric care units.

Kadin's illness began when he was born. When Kadin was 9 months old, his father, Shawn, gave Kadin a kidney. When he was 5, Kadin's body began to reject it -- spurring a need for another. When Kadin was 8, Hoven donated her own kidney, but doctors had to remove it three weeks later because of complications.

But the Hovens said they are hopeful.

"We tell (Kadin) there's a reason for everything," his mother said.

Kadin is currently on dialysis five days a week, for 10 hours a day. But you'd never know it by looking at him.

He loves cross-country, gymnastics and parkour. He recently asked to try baseball. He even gives himself his own growth hormone shots.

The Hovens are able to give Kadin his dialysis at home, but other procedures, like infusions, have to be administered at the hospital. And sometimes those procedures can last several hours, warranting a need for a distraction, like a toy.

"If you are not in the hospital, you have no idea," Hoven said. "For those kids, it's a getaway. It takes their minds off their situations."

Suddenly, something small -- like a toy bin -- makes a big difference. It's a source of joy for kids who need it most. Kadin says his wish is to have the toy drive every year.

Despite Kadin's difficult ride with his health, and despite the effects of a brutal disease, Kadin says he is still thinking about other people. "He's a very selfless, caring little boy," his mother said. "If he sees someone in need, he is the first to take out his chore money and donate."

When asked how much of a difference he thought the toys made to the kids, Kadin said simply:

"Big."

Source: edition.cnn.com

NYC lawmakers pass a novel requirement for free tampons

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NEW YORK (AP) -- New York City is on track to become the nation's first city to require free tampons and sanitary pads in public schools, homeless shelters and jails after lawmakers approved the idea Tuesday amid a national discussion of the costs of having a period.

The proposal, which Democratic Mayor Bill de Blasio's administration supports, marks a new direction in activists' push to dismantle what they see as unfair financial barriers between women and needed sanitary products. New York state lawmakers voted last month to become the sixth state to eliminate sales tax on the items.

City Councilwoman Julissa Ferreras-Copeland's proposal would make pads and tampons free in restrooms that serve 300,000 schoolgirls, and it would guarantee the products' availability to 23,000 women in homeless shelters and add the force of law to jail standards about sanitary supplies.

Supporters say New York would lead cities by having a law, rather than more changeable policies, in a wide range of locales.

"They're as necessary as toilet paper," so they ought to be just as freely accessible, Ferreras-Copeland, a Democrat, said before Tuesday's 49-0 vote.

During the discussion, the council's female speaker waved a wrapped tampon aloft in the spirit of bringing a once-taboo subject into the open. Even a male lawmaker who found the subject a bit uncomfortable praised the proposal.

It's unclear when the mayor will take up the measure, which would provide an estimated 2 million tampons and 3.5 million pads per year in shelters alone. Once dispensers are installed, it's expected to cost about $2.5 million annually in the city's $82 billion budget.

To some extent, schools, shelters and lockups in New York and elsewhere already provide the supplies for free, and the issue has started bubbling up in various lawmakers' chambers. The Dane County Board in Wisconsin, for instance, voted late last year to experiment with providing free tampons and pads in some buildings in the capital county, an idea adapted from a test project that Ferreras-Copeland helped spearhead in 25 New York City schools last year. A Wisconsin state legislature proposal to require the products to be free in public schools and state buildings has stalled so far.

Advocates say the measure also would make the free sanitary supplies more readily available by putting them in restrooms, instead of nurses' offices, in schools with female students in sixth grade and up. Girls who need pads or tampons now have to scramble to try to get to the nurse and then the restroom in breaks between classes, says Lineyah Mitchell, a graduating senior at Brooklyn Technical High School.

Rather than do that and risk being late, girls learn to "know the friend in that class who has extra pads," Mitchell, 17, said at a rally before the vote.

Homeless shelters and jails already provide free menstrual supplies on request, according to the city administration. Women's advocates suggest the supplies are inadequate, but officials say they provide what's needed.

Social Services Commissioner Steven Banks, who oversees homeless shelters, applauded the proposed requirement Tuesday, saying it "expands on and enshrines into law" existing policies.

Meanwhile, New York's statewide sales tax exemption on menstrual supplies is awaiting Democratic Gov. Andrew Cuomo's signature, which is expected.

Several states have weighed eliminating the tax this year, with mixed results. While New York said yes, a Utah legislative committee voted down the idea in March.

Source: www.foxnews.com

Ohio teen dies from suspected brain-eating amoeba

An Ohio teen died Sunday after contracting a suspected brain-eating amoeba while swimming in North Carolina. Lauren Elisabeth Seitz, of Westerville, Ohio, was visiting the U.S. National Whitewater Center in Charlotte with her church’s youth music ministry group when she contracted the infection, WYFF4.com reported.

“They had one day of recreation where they stopped at the U.S. Whitewater Center and went whitewater rafting, and they had a grand day,” Jim Wilson, Seitz’s pastor at the Church of the Messiah United Methodist Church, told WYFF4.com.

Source: www.foxnews.com

Baby born with brain outside skull defies odds 7 months later

During a 20-week ultrasound, doctors told Bentley Yoder’s parents that their son was “incompatible with life,” and that he had a 0 percent chance of survival. Devastated, the Ohio parents considered terminating the pregnancy, but ultimately they decided to carry Bently to term.

“All the way through, I just kept having the feeling that it’s going to be OK, it’s going to be all right,” Dustin Yoder, Bentley’s father, said in a post on Thriving, a Boston Children’s Hospital blog.

In the ultrasound, doctors had detected that brain tissue was bulging out of an opening in Bentley’s skull and diagnosed him with encephalocele. The condition is a rare neural tube defect that occurs when the tube does not close completely during pregnancy. According to the Centers for Disease Control and Prevention (CDC), the condition occurs in one out of 10,000 babies born in the United States each year.

“I specifically remember asking, ‘Is there any chance he could survive?’ They said no— that in the best-case scenario, he’s going to be a vegetable,” Sierra Yoder, Bentley’s mother, said in the blog post. “They made it out like I was going to lose him at any point.”

The Yoders entered the birth excited for the limited time they were expected to have with their son and picked out an outfit to bury him in, but Bentley had other plans. The staff sent the family home with hospice but Bentley was feeding from the bottle, cooing and crying like any other child.

Source: www.foxnews.com

The Difference Between Postpartum Depression and Postpartum Psychosis

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Postpartum psychosis is more rare and involves symptoms like hallucinations

The high-profile quintuple murder case drew national attention in part because of the tragic deaths of the children—who ranged in age from 6 months to 7 years old—and the defense team’s argument that Yates suffered from severe postpartum psychosis, a condition that was then relatively unknown among the public.

Today, advanced research and federal legislation have helped shed more light on the treatment of both conditions, as well as provide more support and screening opportunities for mothers. Celebrity moms, including Nashville actor Hayden Panettiere and mother-of-two Drew Barrymore, have publicly spoken about their battles with postpartum depression. Panettiere in May told her fans on Twitter that the illness has “impacted every aspect” of her life and that she needed to take time to reflect on her health. As the conversations continue, here are the differences between the two conditions:

Postpartum depression

Both occur after childbirth, although postpartum depression is more common. About 1 in 7 women experience symptoms of postpartum depression, according to the American Psychological Association (APA). According to the Centers for Disease Control and Prevention (CDC), the number is closer to 1 in 10.

Symptoms vary depending on the patient but can include frequent crying, anger, anxiety, withdrawal from loved ones, the feeling of numbness or being disconnected from the baby and even sometimes thoughts of hurting yourself or the infant, the APA says.

Those symptoms can appear days or months after childbirth, and may have serious effects. The psychological disorder “can make it hard for you to get through the day, and it can affect your ability to take care of your baby, or yourself,” according to the APA.

Postpartum depression doesn’t go away on its own, but both mild and severe cases can be successfully treated with different forms of psychotherapy and antidepressant medication.

Postpartum psychosis

Postpartum psychosis is rarer than postpartum depression, and involves symptoms that include delusions or hallucinations and can put both the mother and her child in danger, health experts say. The condition affects 1 to 2 out of 1,000 women, and tends to present within the first two to four weeks after delivery, according to a study published in the Journal of Women’s Health in 2006.

The onset of postpartum psychosis is often sudden. In addition to psychotic symptoms, patients can also develop symptoms of paranoia, mood swings and confusion.

Some research suggests the women are most at risk for postpartum psychosis if they have a family history of bipolar disorder or schizoaffective disorder. In rare cases, postpartum psychosis can lead to suicide attempts. Even rarer are attempts at infanticide.

Yates, who is now in a Texas mental hospital, had tried to commit suicide at least once before she drowned her four sons and baby daughter on June 20, 2001. Her attorneys said she suffered from psychotic delusions and had repeated episodes of postpartum depression, TIME reported in 2002. She had multiple violent visions of murder before carrying out the killings.

Yates was convicted of capital murder and was sentenced to life in prison, but her conviction was overturned on appeal. She was found not guilty in 2006 by reason of insanity.

Source: time.com

275 Arrested in Crackdown on Medicare and Medicaid Fraud

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More than $800 million was falsely billed

Federal officials announced on Wednesday that 275 people around the country had been arrested in a crackdown on Medicare and Medicaid fraud.

More than $800 million was falsely billed by those arrested for medically unnecessary services—or services that were never provided at all, NBC News reports. Those who were rounded up include 60 medical professionals, 30 of whom are doctors.

“These takedowns protect and deter fraud in programs that millions of people rely on,” one federal official said.

Officials from the Departments of Justice and Health and Human Services are expected to offer more details on the crackdown Wednesday.

Source: [NBC News]

CDC panel recommends against using FluMist vaccine

(CNN)-Flu vaccines are about to get more painful. A Centers for Disease Control and Prevention advisory committee recommended on Wednesday that FluMist, the nasal spray influenza vaccine, should not be used during the upcoming flu season.

"To everyone's surprise and increasing consternation, this vaccine has performed quite poorly compared to the injectable vaccine," said Dr. William Schaffner, an infectious disease specialist.

An alternative to the standard flu shot, FluMist had been approved for people between the ages of 2 and 49 years old by the Food and Drug Administration.

The CDC committee, which includes 15 immunization experts, reviewed data from previous flu seasons, including the most recent season, comparing FluMist with the standard flu shot.

The decision must now be approved by the CDC director, Dr. Tom Frieden before taking effect.

The FDA first approved the nasal spray in 2003. MedImmune, a subsidiary of London-based AstraZeneca PLC, produces FluMist, a live attenuated influenza vaccine. By contrast, the flu shot is an inactivated influenza vaccine.

Though the viruses in FluMist are live, they have been weakened (attenuated, in medical terms) and work by stimulating the immune system. There are two versions of FluMist: one a trivalent vaccine, which protects against three strains of flu virus, and the other a quadrivalent, protecting against four strains.

"We agree with [the Advisory Committee on Immunization Practices'] decision today to recommend health care providers and parents use only the inactivated vaccine," Dr. Benard Dreyer, president of the American Academy of Pediatrics, said in a statement. The Pediatric Infectious Disease Society also stated its support during the hearing.

Yet, prior to its recent poor performance, all evidence showed the spray worked better than the flu shot in children under the age of 8. And, during those sunny days, the CDC committee expressed a preference for the mist over the shot.

"That lasted exactly a year," explained Schaffner. Still, the nasal spray had become a favorite among pediatricians.

She said one drawback of the nasal spray is it may cause a runny nose for a day or two. "Half the time, these kids have a runny nose anyway, especially young children," she said.

An estimated one-third of all flu vaccinations administered to children are nasal spray, according to the CDC. Pediatricians are likely to be most impacted by Wednesday's recommendation, especially those who have already placed orders for vaccines in advance of the upcoming flu season. "CDC will be working with manufacturers throughout the summer to ensure there is enough vaccine supply to meet the demand," the agency said in a statement.

The FDA had been working with MedImmune to determine why the spray had begun to work so poorly.

Each February, an FDA committee makes the final decision about which virus strains will go into vaccines sold in America for the coming season. Its decision is based on information from more than 100 countries, where influenza-monitoring centers conduct surveillance of circulating viruses. The committee considers which viruses are making people sick, where those viruses are spreading and how well the previous season's vaccine protects against them.

After the committee selects the strains to be used for the vaccine, manufacturers genetically adapt the strains to optimize the vaccine for the production process. Typically, trivalent formulations include two A strains and one B strain, while the quadrivalent formulations add a second B strain.

"So the question is whether there's something in the process that alters the strain," Schaffner said. Because the underlying science is so complex, there are no easy answer, he said.

Dr. Haihao Sun of the FDA's Office of Pediatric Therapeutics said the inconsistent effectiveness results were a concern to the agency.

During the hearing, Dr. Chris Ambrose of MedImmune shared results from the company's 2015-16 influenza vaccine effectiveness study, which found the FluMist quadrivalent vaccine to be 46% effective, compared with the flu shot's 65% effectiveness. However, Dr. Brendan Flannery of the CDC presented data indicating that FluMist had zero effectiveness against one strain of flu.

Acknowledging that FluMist offered advantages in the past, especially for children, Sun said the FDA would continue to work with MedImmune. "At this point, we're not ready to take a requirement for changing prescribing information," he said.

Wednesday's recommendation is an interim decision that could be reversed when the panel reconsiders it next year with additional data.

Source: edition.cnn.com

Biotech stocks surge as Medicare report relieves worries

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The iShares Nasdaq Biotechnology ETF (IBB) popped more than 2 percent on Wednesday, after a U.S. report on Medicare spending showed the government insurer's growth rate hasn't exceeded a target that could trigger cost cuts.

The ETF ended the day modestly higher.

The reprieve relates to a provision in the Affordable Care Act focused on Medicare spending. If spending growth by the government insurer surpasses a certain threshold, a group called the Independent Payment Advisory Board (IPAB) is tasked with recommending cost reductions. Investors feared this could be triggered for 2016, leading to lower spending on drugs.

"Medicare spending didn't trigger initiation of the Independent Payment Advisory Board to slash costs, a relief for the beleaguered drug industry whose shares have slumped since the start of the year" Art Hogan, of Wunderlich Securities said in an email to CNBC.

Proposals from IPAB could affect biotechnology companies, hospitals and insurers, with some restrictions. "This is probably one of maybe five or six things health care investors were concerned about. ... My sense is a fairly low probability IPAB gets enacted and is a cost-cutting device," said Mike Bailey, director of research and chair at FBB Capital Partners.

"In my mind there are other concerns investors should focus on first," he said, referring to potential cost cuts by pharmacy management and insurance companies.

After the Medicare news, the iShares Nasdaq Biotechnology ETF (IBB) reversed earlier losses, to hold more than 1 percent higher. Celgene, Regeneron, Gilead were among the biggest positive influences on biotech index on Wednesday. The IBB fell more than 2 percent Tuesday amid concerns of a trigger to creating IPAB.

Analysts at Jefferies say IPAB is still a concern for the sector, and that much more will be needed to maintain the rally. "It will, though, be important to keep IPAB on the radar for 2017, and with reimbursement/election remaining overhangs for the group, we believe increased M&A activity, positive major clinical data, and/or substantial revenue beats would be needed to fuel a more sustainable rally."

Concerns over pricing pressure have contributed to declines for biotech stocks, with the IBB still down about 24 percent this year.

Source: www.cnbc.com

Opko Health shares climb amid FDA approval for hormone treatment

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Shares of Opko Health spiked more than 5 percent Tuesday after receiving approval from the U.S. Food and Drug Administration for the drug Rayaldee.

The drug is a treatment option for people with secondary hyperparathyroidism, which causes the release of too much parathyroid hormone in the blood, and is associated with vitamin deficiency in adults with stage three or four chronic kidney disease.

About 9 million people in the U.S. deal with secondary hyperparathyroidism, according to the report. Chronic kidney failure is the most common cause for the disease.

The FDA's approval of Rayaldee is an important milestone for Opko, Dr. Phillip Frost, CEO and chairman of Opko, said in a release. He added it "is one of OPKO's many pharmaceutical products being developed for significant medical problems, which will benefit from new treatment options."

Rayaldee is the first drug of its kind to approved by the FDA, Frost said. The treatment failed to win approval in March after the FDA found deficiencies at one of the company's third-party manufacturers.

The company expects to make the drug available in the second half of this year.

Opko's stock has fallen slightly this year, down more than 3 percent.

Source: www.cnbc.com

Emergent BioSolutions clears hurdle for anthrax vaccine facility

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Emergent BioSolutions said Tuesday that the U.S. Food and Drug Administration has completed its pre-approval inspection of Emergent's large-scale facility for making BioThrax, a vaccine for pre-exposure protection against anthrax.

"Emergent is pleased to have reached this critical milestone in our BioThrax comparability program," Adam Havey, executive vice president and president of biodefense division at Emergent, said in the press release.

The company said it looks forward to "timely completing" the process of securing its FDA license for the facility, which is in Lansing, Michigan. A decision is expected by August, the company said.

BioThrax is the only approved anthrax vaccine in the U.S. The company has been supplying it to the Centers for Disease Control and Prevention as part of an effort to develop a U.S. stockpile in the event of a terrorist attack.

Anthrax is an infection caused by a spore-forming bacterium. It mainly effects animals, but humans can contract the infection through contact with infected animals or inhaling spores. Inhaled anthrax can be hard to treat and can be fatal.

Emergent's stock has dropped slightly this year, falling more than 1 percent. The company's shares were mostly unchanged, but were moving back and forth between positive and negative territory.

Source: www.cnbc.com

Google to offer better medical advice when you search your symptoms

Google wants to make it easier for users to find answers to their symptom-related questions.

The internet search engine said Monday it's improving its catalog of searched Googled health symptoms by adding information on related health conditions that have been vetted by the Mayo Clinic and Harvard Medical School.

Type "headache on one side," for example, and Google will offer up a list of associated conditions like "migraine," "common cold" or "tension headache."

For general searches like "headache," the company will also give an overview description along with information on self-treatment options or symptoms that warrant a doctor's visit, according to the company's post.

In Google's official blog, the company said roughly 1 percent of the searches on Google, which equals millions of searches, are related to symptoms users are researching. But search results can sometimes be confusing, and result in "unnecessary anxiety and stress," Google said.

The company plans to use its Knowledge Graph feature, which it launched last year, to enhance the search results it provides.

"We create the list of symptoms by looking for health conditions mentioned in web results," according to Google's blog post, "and then checking them against high-quality medical information we've collected from doctors for our Knowledge Graph."

"By doing this, our goal is to help you to navigate and explore health conditions related to your symptoms, and quickly get to the point where you can do more in-depth research on the web or talk to a health professional," Google wrote.

The new features will be available in English in the U.S. over the next few days. Over time, the company hopes to cover more symptoms and extend its features to other languages and countries, according to the post.

Source: www.cnbc.com

Philadelphia passes soda tax after mayor rewrites playbook

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Philadelphia Mayor Jim Kenney scored a victory that eluded more than 40 U.S. public officials who took on the powerful U.S. soda industry when the city council voted on Thursday to slap a tax on sweetened drinks.

After a bitter, months-long battle, the city council voted 13-4 to approve a 1.5 cent-per-ounce tax on sugary and diet drinks. The council already approved the plan in a preliminary vote last week, and the outcome had not been expected to change.

The City of Brotherly Love became the biggest U.S. city to have such a tax. Much smaller Berkeley, California, was the first.

Similar efforts, including several spearheaded by former New York City Mayor Michael Bloomberg, were defeated after intense lobbying from organizations like the American Beverage Association, which opposes the Philadelphia move and represents Coca-Cola and PepsiCo.

The Philadelphia tax marked a major victory for health advocates who say sugary drinks cause obesity and diabetes. But experts noted those concerns were not the focus for Kenney and other backers of the tax as they took on critics complaining that "nanny state" public health measures intrude on residents' personal lives.

Instead, Kenney rewrote the soda-tax advocate's playbook. He played up the benefits of the cash injection from the tax for the city's depleted coffers. In the first year, the tax is projected to raise $91 million, and he pledged to spend funds on public programs such as universal pre-kindergarten.

The strategic shift could lend momentum to movements in San Francisco, neighboring Oakland, California, and Boulder, Colorado. Residents of those cities will vote in November on similar taxes, which could deal further blows to a U.S. soft drink industry already hit by declining soda consumption.

U.S. soda consumption fell for the 11th straight year in 2015, according to Euromonitor data.

Avoiding the Bloomberg trap

Bloomberg made public health a centerpiece of his tenure as New York City mayor between 2002 and 2013. He moved to limit smoking in parks and restaurants, ban transfats and require calorie counts posted in some restaurants.

On soda, he pushed for a tax, then a ban on soda purchases with food stamps, and finally a much-lampooned limit on the size of sugary drinks. His efforts were ultimately rejected, with critics decrying the moves toward a "nanny state."

The strategy worked in Britain, where a new soft drinks levy was announced in March after officials emphasized the country's obesity crisis, saying it cost the economy billions of pounds annually and was a huge burden on the state-funded health system.

That approach never worked in Philadelphia. Michael Nutter, the previous mayor, twice tried to pass a soda tax as a health initiative and as a way to plug a budget shortfall. He was unable to push it through the city council.

Kenney, who became Philadelphia's mayor in January, had made a campaign pledge to provide universal pre-kindergarten, and he kept that issue as his focus. A spokeswoman said complex state laws on taxation made enacting a citywide soda tax the best option to raise revenue for that signature proposal.

Bloomberg personally contributed funding to support Philadelphia's pro-tax campaigners.

Fizzing westward

Opponents of Philadelphia's soda tax argued that the measure will disproportionately hurt the poor and prompt Philadelphians to travel to nearby suburbs to buy soda.

In Colorado, Boulder hopes to use soda tax revenue on health programs, and San Francisco and Oakland officials would recommend but not require funds raised to go toward obesity and diabetes prevention.

When Berkeley passed its soda tax in 2014, industry groups dismissed the measure as a fluke given the city's largely white population and reputation as a hotbed for liberal measures.

But Philadelphia is the fifth-largest U.S. city, with 1.6 million people. "No one can trivialize it as they can trivialize Berkeley," said Larry Tramutola, a California political strategist who worked on the Berkeley campaign and is currently leading the San Francisco and Oakland efforts.

Source: www.cnbc.com

AIG Mortgage Unit Files for IPO With JPMorgan, Morgan Stanley

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American International Group Inc.’s mortgage insurer, United Guaranty Corp., filed for an initial public offering as the parent company faces sustained pressure from activists to split up.

United Guaranty filed for an offering of $100 million, a placeholder figure that is used to calculate fees and will probably change. United Guaranty won’t receive any of the proceeds of the share sale, according to its IPO filing. JPMorgan Chase & Co. and Morgan Stanley are underwriting the deal.

AIG Chief Executive Officer Peter Hancock has faced continued calls from activist investors Carl Icahn and John Paulson to pursue a more drastic breakup of the company. Hancock has already said he’s planning to fully exit United Guaranty. In January, a plan was announced to sell up to 19.9 percent of the United Guaranty business in an IPO, the first step to a full separation.

The move comes at a quiet time for U.S. IPOs. The number of public offerings has languished of late as stock markets have been hit by volatility. Only nine companies -- all in the health-care industry -- have gone public this year, while others across industries have postponed their offerings.

AIG’s mortgage guarantor is the largest of its U.S. peers. Radian Group Inc., the No. 2 business by market share according to Bloomberg Intelligence, has dropped 8 percent this year amid stricter capital rules and heightened competition. Paulson, whom AIG agreed in February to nominate to its board, has invested in Radian.

United Guaranty reported net income of $359.8 million last year, down 8.6 percent from 2014. Revenue declined 11 percent to $922.6 million in the 12 months through December.

Since the separation plan was announced, United Guaranty has been deemed more risky by Standard & Poor’s. The rating agency downgraded the company this month on the view that the company would not benefit from implicit ongoing support from its parent after the spin off.

United Guaranty plans to list on the New York Stock Exchange.

Source: Bloomberg

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