Review Category : Health

Scopes that Spread UCLA ‘Superbug’ Were Awaiting FDA Clearance

File photo. (iStock/Thinkstock)(LOS ANGELES) — The manufacturer of the scopes that spread a drug-resistant “superbug” to seven California patients had tweaked the scopes’ design and was selling them without federal permission to do so, according to the Food and Drug Administration.

Seven people have become infected with the drug-resistant “superbug” known as CRE at Ronald Reagan UCLA Medical Center after undergoing endoscopy procedures, and CRE may have played a role in two of those patients’ deaths, hospital officials said in February, adding that 179 people were exposed to the germ at UCLA.

The scopes — called duodenoscopes, which are inserted by mouth to access patients’ small intestine, the pancreas and the liver — were new and had only been in use since June, health officials said last month. Officials added that the scopes were cleaned in accordance with manufacturer guidelines. The hospital said it traced the bacteria back to two endoscopes manufactured by Olympus Corporation of the Americas.

According to the Food and Drug Administration, Olympus had tweaked the design of its duodenoscopes and sold them without seeking clearance from the FDA to do so. Manufacturers are supposed to notify the FDA of design changes 90 days before marketing an altered device, according to the FDA website.

It was not immediately clear what Olympus changed about the scopes’ design or whether that change could have made the scopes more likely to harbor bacteria or more difficult to clean and sanitize — and the FDA was not immediately able to clarify.

In March 2014, the FDA notified Olympus that it needed the additional clearance before selling the altered devices, but the manufacturer did not submit the request for clearance until October, the FDA told ABC News. The submission is still “pending” because the FDA asked for more data.

The FDA noted two other companies make duodenoscopes, and FDA spokeswoman Karen Riley told ABC News, “It’s important to understand that we have received reports of infections associated with the duodenoscopes manufactured by all three device companies.”

The Food and Drug Administration told ABC News last month that it has been aware of cleaning issues and bacterial transmissions associated with duodenoscopes for more than a year.

“The CDC first alerted the FDA to a potential association of multi-drug resistant bacteria and duodenoscopes in fall 2013,” an agency spokesperson told ABC News. “The FDA has been actively working with federal partners, manufacturers and other stakeholders to better understand the issues that contribute to the infections and what can be done to mitigate them.”

The FDA issued a safety communication about the duodenoscopes following the UCLA CRE cases, explaining that duodenoscopes are used in about 500,000 procedures a year, but meticulous cleaning and disinfecting “may not entirely eliminate” the risk of transmitting infection. From January 2012 through December 2014, the FDA received reports of 135 patients suspected of contracting germs from reprocessed duodenoscopes, the agency said.

According to the CDC, almost every state has had a confirmed case of CRE, but state health departments are not required to notify the CDC about CRE infections. Duodenoscope-related CRE outbreaks similar to the one at UCLA have occurred recently in Chicago, Pittsburgh and Seattle.

Olympus did not respond to repeated requests for comments about the FDA’s assertion that the scopes lacked FDA clearance, but the company said in a statement to ABC News last month that it was aware of reports involving its duodenoscopes, and was working with the FDA, medical organizations and customers to address concerns. It was also making supplemental educational materials available to customers.

“While all endoscopes, including duodenoscopes, require thorough reprocessing after patient use in order to be safe, the Olympus TJF-Q180V requires careful attention to cleaning and reprocessing steps, including meticulous manual cleaning, to ensure effective reprocessing,” the company said.

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Everybody’s Gone Biking USA

iStock/Thinkstock(NEW YORK) — Believe it or not, pretty soon it’ll be nice enough in most areas of the country to get outside and do things that don’t involve shivering and shoveling.

One of America’s favorite outdoor pastimes, according to a study commissioned for the nonprofit PeopleForBikes, happens to be bicycling.

Contrary to other reports that indicated participation is far lower, PeopleForBikes says that just over a third of Americans ages three and up rode a bike at least once last year.

PeopleForBikes’ President Tim Blumenthal says its U.S. Bicycling Participation Benchmarking Report is comprehensive whereas other studies seem to focus on single aspects of bicycling. Blumenthal says his study covers recreational biking, transportation riding and other uses for bikes.

But even though 57 percent of people who biked in 2014 did so for recreation, the study found that 48 percent of Americans don’t have access to bikes and 52 percent are concerned about the danger of getting into an accident with a vehicle.

However, Blumenthal says he sees plenty of potential in reaching millions of people who otherwise might not think biking is in their spring and summer plans.

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Your Gluten-Free Diet May Be a Tax Write-Off

iStock/Thinkstock(NEW YORK) — Cutting bread from your diet could potentially save you some bread on your taxes, financial experts say.

While diet gurus debate the health merits for the average person of avoiding the gluten protein found in wheat, rye and barley grains, no one disputes the extra cost. On average, the gluten-free versions of many foods were 242 percent pricier than the regular products in one National Institutes of Health study.

But Mark Luscombe, a principal federal tax analyst for the tax publisher CCH, said some of the additional expense of going gluten-free may be a legitimate tax write-off.

“If you have a recognized disease where gluten-free foods help manage the condition and you have a certification from your doctor, you may be able to take a deduction,” Luscombe said.

This could be good news for the 1 percent of the population with celiac disease, a diagnosed intolerance to gluten that causes severe gastrointestinal symptoms and increases the risk of some cancers. They should be able to write off the extra cost of buying gluten-free items plus the cost of shipping if they buy them online. Foods that contain xanthan gum and sorghum flour can be fully deducted because they have no gluten-filled alternative.

As for the other 30 percent of Americans who, according to the consumer research group NDP, avoid gluten because they believe they have some sort of insensitivity to it? Luscombe said he doubted such a write-off would fly.

Even someone with celiac will have to work hard for the tax break, Luscombe said. They will need a note from their doctor and they will have to keep meticulous track of how much more they spend on gluten-free products than on other similar products, he added.

That means saving all receipts and making notes of price differences. In addition, to get any deduction, all medical expenses must exceed 10 percent of gross adjusted income or 7.5 percent for people older than 65, Luscombe said.

For those who can clear all those hurdles, using medically sanctioned dietary restrictions as a tax write off does have the support of the Internal Revenue Service, Luscombe said. IRS Information Letter 2011-0035 states: “The excess cost of specially prepared foods designed to treat a medical condition over the cost of ordinary foods which would have been consumed but for the condition is an expense for medical care.”

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Family of Brain-Dead Pregnant Woman Now Fighting to Change State Law

iStock/Thinkstock(AUSTIN, Texas) — A family that had to go to court to get a brain-dead woman taken off life support is now fighting to change Texas law so other families won’t have to go through the same ordeal.

The family of Marlise Munoz is working with Texas lawmakers to craft a new bill that could make it easier for families to have end-of-life decisions in regards to a pregnant woman, according to a new documentary in production currently titled, The Pregnancy Exclusion.

“I just don’t think the government can make this decision for anybody,” Munoz’s husband, Eric Munoz, says in a clip from the upcoming film.

Eric Munoz did not immediately respond to a request for further comment made through the film producers.

The case of Marlise Munoz made international headlines after the 33-year-old pregnant paramedic was declared brain dead. While Munoz’s family wanted her taken off life support, a Fort Worth, Texas, hospital refused after citing a little-known state law that prohibited removing “life-sustaining” treatment for a pregnant patient.

The family eventually won the case in January 2014 after a judge ruled the law did not apply to Munoz because she was already deceased.

The Pregnancy Exclusion, follows the family as they figure out how to navigate the state legislature system in the hopes they can change the law itself.

Eric Munoz talks in the film about what it was like to see his wife put on life support after being declared brain dead.

“You have a body there and you try to respect it and talk to it, but then at the same time you’re like she’s passed away, she’s dead,” he says in a clip that has been made available in advance. “So you talk in your head like she can listen to you in Heaven.”

Munoz said at some point he could tell his wife was deteriorating under life support.

“Her hands went from being pliable to being very rigid, very stiff,” he said. “You’re seeing a body slowly deteriorate.”

Munoz, along with his parents-in-law, faced international scrutiny as both pro- and anti-abortion advocates took on the case.

“You hear people say, ‘You’re a monster to you’re going to hell,’” Eric Munoz says in a film clip. “’Why isn’t he thinking about the baby?’ …[People] literally accused me of murder.”

The fight over how the law perceives the rights of incapacitated pregnant women is likely to continue for some time. Last month, a Republican state lawmaker introduced a bill that would make it illegal to stop life-sustaining treatment for a pregnant woman even if there is “irreversible cessation of all spontaneous brain function.”

Rebecca Haimowitz, director of The Pregnancy Exclusion, said the family is preparing to testify against that bill once it is brought up in a hearing.

“The family has gone on this journey from their own personal tragedy and to activism,” said Haimowitz. “They certainly didn’t ask for it.”

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Flat Shoes Linked to Women’s Foot Problems

iStock/Thinkstock(NEW YORK) — For many women, sensible, comfortable flats are a wardrobe staple.

Despite the shoes’ popularity, however, some experts have a warning. They say some types of flats can lead to a host of potential health problems, including toe infection, that could even require surgery.

The damage is caused when tight, pointy-toed flats put pressure on toenails, causing them to bend and become ingrown. In some cases, if the situation is left untreated it could lead to bone infection.

It happened to 17-year-old Hannah Butler. The Illinois teen had to resort to surgery to remove an ingrown toenail caused by repeated use of the wrong flats.

“I brought my shoes in to my doctor…he figured that that was causing the multiple ingrown toenails,” she said.

Experts say the problem happens because most women are unaware of what some flats are really doing to their feet.

“It’s funny because so many women think they’re better off wearing flats than heels but in reality…flats can be worse than heels 100 times over,” Dr. Marlene Reid, a podiatrist and spokeswoman for the American Podiatric Medical Association, said.

But you don’t have to get rid of flats altogether from your wardrobe. Experts say you should wear flats with rounded or squared-shapes toes. It gives toes wiggle room and alleviates pressure on the big toe.

Reid said there are many different styles of flat shoes available.

“Flats come in all different styles, all different types, all different construction,” Reid said. “There are flats that are more flimsy than what we consider regular flats.”

“You have to look at the shoe itself to determine if it’s the right shoe for you,” she said.

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Even a Good Dog Doesn’t Have Much of a Good Memory

iStock/Thinkstock(STOCKHOLM) — Your dog might be a good boy but boy, don’t count on him to remember too much.

That’s the advice from Stockholm University and Brooklyn College researchers who conducted memory experiments on various animals as well as birds and insects and yes, people too.

Overall, the average memory for all animals is around 27 seconds. Surprisingly, the memory of chimps only lasted 20 seconds, worse than that of rats. Humans were the best, thankfully, remembering stimulus from two days earlier.

As for dogs, the best they could do was remember an event from two minutes earlier, which was at the high end. Dogs actually are very good when it comes to specialized memories, such as where you hid a treat or toy.

However, don’t expect them to remember a visit to the park. They just don’t have the capacity to recall events, which may be a blessing in disguise if you got chased out of the park for not keeping your mutt on a leash.

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Sad Movies Can Compel Mindless Snacking

iStock/Thinkstock(ITHACA, N.Y.) — If you enjoy movies that bring a tear to your eye, you also enjoy eating. Or perhaps, you don’t realize you’re stuffing your face more while watching sad films as opposed to comedies.

In a Cornell Food and Brand Lab study of movies watched over last Thanksgiving, people consumed 28 percent more popcorn while watching the old tearjerker Love Story than the comedy Sweet Home Alabama.

That particular study was conducted in a lab. Researchers also went dumpster diving outside movie theaters in seven cities where they gathered both emptied popcorn boxes and discarded popcorn and again discovered that 55 percent more popcorn was eaten during a sad movie as opposed to the comedy, My Big Fat Greek Wedding.

How does lead researcher Brian Wansink explain this phenomenon? His theory is that eating can be triggered by emotion and people will eat more to compensate for sadness. It doesn’t necessarily have to be junk food either. People will also chow down on veggies and fruits if they’re around.

Therefore, if you are worried about mindless eating, Wansink recommends, “Keep snacks out of arms reach, ideally leave them in the kitchen and only bring to the couch what you intend to eat.”

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Sad Movies Can Compel Mindless Snacking

iStock/Thinkstock(ITHACA, N.Y.) — If you enjoy movies that bring a tear to your eye, you also enjoy eating. Or perhaps, you don’t realize you’re stuffing your face more while watching sad films as opposed to comedies.

In a Cornell Food and Brand Lab study of movies watched over last Thanksgiving, people consumed 28 percent more popcorn while watching the old tearjerker Love Story than the comedy Sweet Home Alabama.

That particular study was conducted in a lab. Researchers also went dumpster diving outside movie theaters in seven cities where they gathered both emptied popcorn boxes and discarded popcorn and again discovered that 55 percent more popcorn was eaten during a sad movie as opposed to the comedy, My Big Fat Greek Wedding.

How does lead researcher Brian Wansink explain this phenomenon? His theory is that eating can be triggered by emotion and people will eat more to compensate for sadness. It doesn’t necessarily have to be junk food either. People will also chow down on veggies and fruits if they’re around.

Therefore, if you are worried about mindless eating, Wansink recommends, “Keep snacks out of arms reach, ideally leave them in the kitchen and only bring to the couch what you intend to eat.”

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Kelly Gissendaner: Explaining the ‘Cloudy’ Drug That Stopped Georgia Execution

Georgia Department of Corrections(ATLANTA) — The execution of a Georgia woman was halted Monday mere hours before she was scheduled to be put to death, after officials said they found the lethal injection drug was “cloudy.”

The delayed execution comes as prisons have faced increased scrutiny over lethal injection procedures. Some drugs traditionally used in lethal injections have become scarce as suppliers have refused to allow the drugs to be used in executions.

Dr. Howard Nearman, an anesthesiologist at University Hospitals Case Medical Center in Cleveland, told ABC News on Tuesday that if the drug was “cloudy,” it could indicate that it was contaminated or a particulate ingredient did not fully disintegrate.

“Those [compounding pharmacies] are notoriously unreliable,” he said before explaining the only supplier currently available is a Danish company, which has tried to restrict the drug so it cannot be used for lethal injections, leaving some prisons to rely on compounding pharmacies.

Pentobarbital is a sedative that causes brain sedation and can lead to coma and, in cases of overdose, respiratory arrest.

Nearman, who had no involvement in this case, said he was also concerned that the people administering the drugs could lack necessary medical expertise, noting the correct dose of a sedative can be difficult to administer correctly.

“The trouble is there’s tremendous variability depending on what drug level is enough,” he said.

Certified anesthesiologists risk losing their certification if they consult or participate in an execution, according to a 2010 notice from the American Board of Anesthesiologists.

Kelly Gissendaner was scheduled to be the first Georgia woman in decades to be executed by lethal injection, in this case with pentobarbital, before the execution was postponed.

Gissendaner was sentenced to death after being convicted of her husband’s murder in 1997.

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Virus Delays Homecoming for Toddler Who Received Liver From Dad

Liver Transplants for our Vietnamese Twin Girls/Facebook(TORONTO) — A long-awaited homecoming was delayed for a toddler who received a liver transplant, with her father as the donor, after she contracted a virus.

Phuoc Wagner made headlines along with her twin sister Binh when both girls needed a liver transplant to survive and their father, Michael Wagner, could only donate to one. Phuoc underwent the surgery last month after doctors determined she needed the operation sooner than her sister.

While both the 3-year-old girl and her father are recovering, Phuoc’s return home was delayed this week after she contracted the norovirus, or stomach flu, according to the family’s Facebook page.

“No homecoming yet: norovirus is keeping Phuoc in hospital,” Johanne Wagner, the twin’s mother, wrote on Facebook. “And norovirus in my house as well. Homefront needs to be clear before they can come home.”

Johanne Wagner also confirmed they still are waiting to hear about the possibility of a living donor for Binh Wagner. Both Binh and Phuoc needed liver transplants after suffering liver damage because of a genetic condition called Alagille syndrome.

In an earlier post this week Johanne Wagner said she worried about having Phuoc back after her transplant.

“It is scary though to welcome her back so soon after transplant,” Wagner wrote on Facebook. “A lot of new stuff to assimilate. Daily nursing visits for weeks to come to administer IV meds and perform bloodwork. But most of all, the fear of something going wrong, and quickly.”

However, Wagner said she is eager for Phuoc to reunite with her twin sister Binh. She posted a few pictures of Binh this week playing and even dancing with her older brother.

According to an earlier report from the Canadian Broadcasting Company, the Hospital for Sick Children in Toronto has received 400 submissions from people offering to be a living donor for Binh.

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