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October 13, 2015   Download print version

Pain-pill guidelines for children spark a fierce debate

Elephants' low cancer rates explained

Ask a MacArthur genius: How are hospitals trashing the planet?

New website with information on the proper disposal of used needles

Study analyzes use of 7 low-value services in Choosing Wisely Campaign

Doctors 'failed to spot' Ebola nurse Pauline Cafferkey had fallen ill again

Pfizer is targeting a deadly bacterium that thrives in hospitals

Study reveals why gowns and gloves can be so dangerous for hospital workers


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Pain-pill guidelines for children spark a fierce debate

The Food and Drug Administration’s decision in August to officially approve use for certain children as young as 11, meaning doctors wouldn’t have to prescribe it off label, has triggered fierce debate.

On one side are some elected officials and addiction specialists who say the move could expand access to a drug at the center of an epidemic of painkiller and heroin abuse in the U.S. that was responsible for 24,000 overdose deaths in 2013.

On the other are some physicians and families say the FDA move provides necessary guidance to doctors treating children with serious conditions. Doctors have had to rely on adult dosing information when prescribing the painkiller to children off label.

OxyContin is an extended-release version of oxycodone, an opioid painkiller. Because of its formulation, it can smooth out peaks and valleys of pain. Patients 19 and younger represented about 1% of dispensed prescriptions for oxycodone in 2014, according to IMS Health Holdings Inc., a healthcare data company.

After requesting that the maker of OxyContin, Purdue Pharma LP, perform studies of the drug’s effects on children, FDA officials determined it was safe for youths 11 and older and established appropriate prescribing guidelines.

Expanded use of OxyContin in pediatric patients isn’t the intent, FDA officials say. The agency approved the drug only for treating those with severe, long-term pain, such as cancer patients or those recovering from major spinal surgery, who were already taking an opioid painkiller.

After marijuana, psychotherapeutics - a category that includes painkillers - are the most-abused group of drugs among children ages 12 to 17, according to the Substance Abuse and Mental Health Services Administration. Nonmedical use of OxyContin among 10th- and 12th-graders increased from 2002 to roughly 2009, but it has declined since then, according to the annual Monitoring the Future survey, which tracks youth drug use.

Some elected officials in states grappling with rampant painkiller abuse are furious.

But Donna Ludwinski, director of research programs at Solving Kids’ Cancer, a research-advocacy group, said a child who starts taking OxyContin illicitly presents a separate issue—one she said she is familiar with, living in an area of West Virginia devastated by painkiller abuse.

On Sept. 18, eight U.S. senators, including Joe Manchin (D-WV) and Kelly Ayotte (R-NH), signed a letter to the FDA “to express our dismay” and to call for a review of its decision.

Another group of lawmakers has requested a Senate hearing to examine the FDA’s decision. And Manchin is promoting a bill that would require the agency to consult with an advisory committee before approving any opioid painkillers and, if it rejects the panel’s advice, to explain before Congress why. Visit the Wall Street Journal for the article.

Elephants' low cancer rates explained

Elephants have enhanced defenses against cancer that can prevent tumors forming, say scientists. They were trying to explain why the animals have lower levels of cancer than would be expected by their size.

The team at the University of Utah said "nature has already figured out how to prevent cancer" and plan to devise new treatments. But experts said the focus should be on the "ridiculous" and "absurd" things humans do to increase risk.

There is a train of thought that says every cell can become cancerous so the more of them you have, the more likely you are to get cancer. So if an elephant has 100 times as many cells as a person then the trunk-swinging mammals should be 100 times more likely to have the disease.

And yet the analysis, published in the Journal of the American Medical Association, showed only 5% of elephants die from cancer compared to up to 25% of people. The scientists turned to the elephant's DNA - the blueprint of life - to find an explanation.

Cancer is caused by mutations in a cell's DNA that produce faulty instructions leading to rampant growth as the cell spirals out of control,

But animals also have "smoke alarms" that detect the damage and either lead to the cell being repaired or killed. One of these alarms is called TP53, and while humans have one TP53 gene, elephants have 20. As a result, elephants seem far more keen to kill off cells on the cusp of going rogue.

Dr Joshua Schiffman, one of the researchers and a pediatric oncologist, said: "By all logical reasoning, elephants should be developing a tremendous amount of cancer, and in fact, should be extinct by now due to such a high risk for cancer.

But Prof. Mel Greaves, from the Institute of Cancer Research in London, says we should focus on why humans have such high levels of cancer.

He told the BBC News website: "In terms of adaptive mechanisms against cancer we have the same as a chimp, but we get a lot more cancer than a chimp."

In an evolutionary sense "success" is judged by the number of descendants you have rather than how long you live.

Elephants have the greatest reproductive success towards the end of their lives, while humans can live for decades after the menopause.

It means there is little evolutionary pressure in humans to develop ways of preventing cancer in old age. Visit BBC for the report.

Ask a MacArthur genius: How are hospitals trashing the planet?

It’s not every day that an environmental activist becomes a leading voice in healthcare, but that’s what happened to Gary Cohen, a new MacArthur fellow. By looking under the hood of hospitals, he’s discovered a few nasty secrets — and inspired big changes for a community of scientists and practitioners whose healing practices were actually hurting the world around them.

“We want hospitals to clean up their own house,” said Cohen, whose organization, Hospitals Without Harm, has managed to tackle issues as diverse as the use of mercury in medicine and what hospital patients eat.

A keen environmentalist, Cohen’s ears perked up in the 1990s as he started to hear about endocrine-disrupting chemicals like dioxins. These nasty compounds are found in the environment, but they persist in the fatty tissues of humans and animals, messing with hormones, compromising the immune system and even causing cancer. When Cohen heard that hospitals were the largest source of dioxin emissions in the United States, it stopped him in his tracks.

“Hospitals were the poster child for this chemical,” he recalled, noting that they then had to treat people whose endocrine systems they’d destroyed. “It was insane! Hospitals were poisoning people in the service of healing them.” Cohen started digging, lifting the proverbial log that was the healthcare system and finding a seething underbelly of bugs, dirt and distasteful practices. Not only were hospitals spewing dangerous chemicals into the environment, but they were also disposing of huge amounts of mercury from thermometers — mercury that then made its way into the water supply, fish and back into human bodies.

And then there were the incinerators. At the time, hospitals burned most of their trash. Cohen remembers seeing plastic tubing, pizza boxes and even computers thrown into on-site incinerators along with medical waste like pharmaceutical products. But when he and his colleagues contacted hospitals to find out who was in charge of regulating their stoves, they learned that they were being advised by incinerator salespeople, not sustainability experts.

Cohen sees the problem with healthcare as one of miscommunication. Hospital administrators don’t always realize that it can cost less to implement sustainable practices, especially ones that allow them to flex their buying power to further drive down cost. Professional training is a concern, too.

There’s still work to be done - and lots of it. Hospitals themselves admit that they are part of the problem: In 2012, the Healthier Hospitals Initiative estimated that the average hospitals generates 26 pounds of waste per staffed bed per day. (That’s exponentially higher than the average of 4.40 pounds of solid waste the Environmental Protection Agency estimates is produced by individual Americans). And a 2014 Harris poll sponsored by Johnson & Johnson found that just 22 percent of hospitals have a current purchasing policy that takes the environment into consideration. Visit Washington Post for the story.

New website with information on the proper disposal of used needles

NeedyMeds has released a redesigned, updated and expanded website containing the most comprehensive information on the proper way to dispose of used needles, syringes and other sharps.

"We spent over a year compiling information on the regulations and disposal sites for all 50 states," said Leah Zaroulis, the project lead person. "We list over 2,600 disposal sites for home-generated sharps through out the country."

Proper disposal of used needles, syringes, and other sharps exposed to bodily fluids is a growing issue. Improperly-disposed sharps exposes workers to a variety of potentially serious diseases including HIV, hepatitis and other blood borne pathogens.

"There is no charge to use the website and all use is anonymous," said Zaroulis. "Our goal is to make the site as easy as possible to use. There is no registration or log in and we learn no identifiable information about those who use the website. People can also call our toll-free helpline 9am-5pm Eastern Time at 1-800-643-1643."

The website, previously managed by the Coalition for Safe Community Needle Disposal, was totally redesigned and all the information updated. The site includes information on pharmaceutical company take-back programs, state health and solid waste department contacts, and general information on the proper handling and disposal of used needles and syringes.

Study analyzes use of 7 low-value services in Choosing Wisely Campaign

An analysis of seven clinical services with minimal benefit to patients identified as part of the Choosing Wisely campaign found significant declines in two services: the use of imaging for headaches and cardiac imaging in low risk patients, according to an article published online by JAMA Internal Medicine.

Reducing the use of unnecessary medical procedures and treatments is important in controlling health care expenditures. Choosing Wisely includes more than 70 lists of about 400 recommendations of frequently used medical practices or procedures that are of minimal clinical benefit to patients. 

Abiy Agiro, Ph.D., of HealthCore, Wilmington, DE, and coauthors examined the frequency and trends of some of the earliest Choosing Wisely recommendations from 2012 using medical and pharmacy claims from Anthem-affiliated Blue Cross and Blue Shield healthcare plans for about 25 million members. 

The authors identified seven services: imaging tests for headache with uncomplicated conditions; cardiac imaging for members without a history of cardiac conditions; preoperative chest x-rays with unremarkable history and physical examination results; low back pain imaging without red-flag conditions; human papillomavirus (HPV) testing for women younger than 30; antibiotics for acute sinusitis; and prescription nonsteroidal anti-inflammatory drugs (NSAIDs) for members with select chronic conditions (hypertension, heart failure or chronic kidney disease).

The authors found:

·         Use of imaging for headache decreased from 14.9 percent to 13.4 percent

·         Cardiac imaging decreased from 10.8 percent to 9.7 percent

·         Use of NSAIDs increased from 14.4 percent to 16.2 percent

·         HPV testing in younger women increased from 4.8 percent to 6.0 percent

·         Antibiotics for sinusitis remained stable decreasing only from 84.5 percent to 83.7 percent

·         Use of pre-operative chest x-rays (ending utilization 91.5 percent) and imaging for low back pain (53.7 percent utilization throughout the study) remained high with no significant changes

Although four of the seven had statistically significant changes, which is unsurprising given the large sample size, the clinical significance is uncertain, the authors note. 

The authors acknowledge limitations because the study was based on administrative claims data that do not adequately capture the clinical circumstances that led to the service being ordered so the recommendation may be appropriate for an individual patient. Visit JAMA for the study.

Doctors 'failed to spot' Ebola nurse Pauline Cafferkey had fallen ill again

The family of nurse Pauline Cafferkey have claimed doctors "missed a big opportunity" to spot she had fallen ill with Ebola again when she was told she had a virus when she attended a clinic.

Toni Cafferkey said it was "absolutely diabolical" the way her sister, who originally contracted Ebola while volunteering in Sierra Leone last year, had been treated.

Pauline Cafferkey, 39, was admitted to the Queen Elizabeth University Hospital in Glasgow on Tuesday after feeling unwell. She has since been flown to the Royal Free Hospital in London where she is being treated in an isolation unit.

Toni Cafferkey told the Sunday Mail that her sister had gone to a GP out-of-hours clinic at the Victoria Hospital in Glasgow on Monday night but the doctor who assessed her diagnosed a virus and sent her home.

"We don't know if the delays diagnosing Pauline have had an adverse effect on her health, but we intend to find out. It has not been good enough.

NHS Greater Glasgow and Clyde told the paper: "We can confirm that Pauline did attend the New Victoria Hospital GP out-of-hours service on Monday.

"Her management and the clinical decisions taken based on the symptoms she was displaying at the time were entirely appropriate.

"All appropriate infection control procedures were carried out as part of this episode of care."

Pauline Cafferkey, 39, from South Lanarkshire, was diagnosed with Ebola in December after returning to Glasgow from Sierra Leone via London.

She was critically ill and spent almost a month in an isolation unit at the Royal Free Hospital before being discharged in late January.

Ebola has been shown to persist for weeks or even months in parts of the body and in bodily fluids. Visit the Telegraph for the story.

Pfizer is targeting a deadly bacterium that thrives in hospitals

Staphylococcus aureus can strike healthy, young people with no known risk factors, survive a barrage of antibiotics, and sometimes be fatal. The bacterium, which often resides on people’s skin, is usually harmless. But some varieties can turn deadly if they lead to an infection that invades the lungs or bloodstream.

One antibiotic-resistant strain frequently found in hospitals is responsible for about 75,000 serious infections and 10,000 deaths in the U.S. a year, according to the Centers for Disease Control and Protection. Attempts to create a vaccine have been disappointing. That hasn’t stopped Pfizer from trying.

The pharmaceutical giant has spent more than 15 years working on a vaccine against the bug and is in the midst of testing it on patients preparing to undergo elective spinal surgery. A 2,600-person trial is expected to be completed in 2017, and, depending on the results, the data could be submitted to the U.S. Food and Drug Administration in support of Pfizer’s application for regulatory approval.

If the trial produces a viable drug, Divan predicts Pfizer’s annual revenue from the single-shot vaccine could reach as much as $5 billion. That would make it one of the most lucrative vaccines of all time. It would also help Pfizer replenish its pipeline following patent expirations for profitable blockbusters such as cholesterol treatment Lipitor and arthritis drug Celebrex.

Other drugmakers have tried to bring a staph vaccine to market. Robert Daum, director of the University of Chicago’s MRSA Research Center, says prior experimental vaccines were able to ignite an immune response in trial patients, but not in a way that protected them against infection.

Nabi Biopharmaceuticals, before its 2012 merger with Biota Pharmaceuticals, failed to show that its staph aureus vaccine could prevent infection in a late-stage, 3,600-person trial. Merck gave up on staph vaccine development in 2011 after its trial of 8,031 patients showed that while those who received the vaccine developed antibodies to ward off the bacterium, they were also more likely to die if infected.

Pfizer’s researchers are trying a multipronged approach. Two of the vaccine’s components go after a capsule that cloaks the bacterium and prevents the immune system from recognizing it. Another deprives the organism of manganese, which staph needs to stay alive and fight the body’s immune response. A fourth targets the mechanism staph uses to lodge itself in the body and let the infection take hold. Pfizer, in an e-mailed statement, described the results from a previous trial of the vaccine as “encouraging.”

Daum is worried Pfizer’s vaccine won’t protect against types of staph that are more prevalent outside hospitals. “What I’m looking for is a more generalizable vaccine that works against multiple staph syndromes and multiple strains.” The company says it sees the potential to expand the uses for its staph vaccine. Says Pfizer’s Anderson: “One could envision there are many areas and populations that could benefit from prevention of this disease.”

The bottom line: Pfizer’s vaccine against staph aureus, now in trials, could become a $5 billion-a-year blockbuster - if it works. Visit Bloomberg for the story.

Study reveals why gowns and gloves can be so dangerous for hospital workers

A hospital ought to be the last place to get a life-threatening infection, but it happens. A new study helps explain why.

Researchers asked real hospital workers to remove gowns and gloves smeared with fake bacteria. When they did, the fake bacteria wound up on their skin or clothes 46% of the time, according to their report published Monday in JAMA Internal Medicine.

In other words, the odds that these healthcare professionals could take off their protective coverings without contaminating themselves were only slightly better than the flip of a coin.

The hospital workers weren’t staffing the gift shop or validating parking tickets. Of 435 simulations performed in the study, 246 were done by nurses, 72 by doctors and 117 by folks like phlebotomists, physical therapists, dietitians and radiology technicians.

The researchers, led by Dr. Myreen Tomas of the Cleveland Veterans Affairs Medical Center, recruited these volunteers from four hospitals in the Cleveland area. The workers put on “contact isolation gowns” and nitrile gloves, then were given half a milliliter of a fluorescent lotion that glowed under a black light - a stand-in for invisible pathogens. They were asked to rub the lotion on their gloved hands for 15 seconds, then wipe their hands over their gowns. After that, they got a clean pair of gloves.

Next, the volunteers were asked to remove their gowns and gloves the way they normally would. When they were done, the researchers used the black light to see if any lotion was left behind.

The hospital workers got the lotion on their clothes and skin 38% of the time when they took off their gowns and 53% of the time when they took off their gloves. Overall, the average “contamination” rate was 46%.

Employees of all four hospitals were about equally likely to contaminate themselves, the researchers found. In addition, all of the different kinds of workers were about equally likely to make a mistake in putting on or taking off their personal protective equipment. The most common mistakes were failure to pull gloves over the wrist, taking gowns off over the head (instead of pulling them away from the body), putting on gloves before the gown and touching the outside of a dirty glove when taking it off.

When volunteers made a mistake, they wound up contaminated 70% of the time. But even when they followed the procedures perfectly, they still contaminated themselves 30% of the time.

Tomas’ hospital responded to these results by launching an effort to train employees on how to don and doff gowns and gloves according to the protocols recommended by the Centers for Disease Control and Prevention. Workers watched a 10-minute video, then practiced their technique for 20 minutes.

It certainly helped. The training reduced the contamination rate from 60% all the way down to 19%, according to the study. But it wasn’t perfect.

“Although contamination of skin and clothing was reduced by the intervention, it was not reduced to zero,” the study authors wrote.

The results help explain why multidrug-resistant bacteria are such a stubborn threat in hospitals. Other studies of real-world conditions have found that between 2% and 5% of hospital workers caring for colonized patients wind up with the pathogens on their hands after taking off their gloves. In one study, 24% of those treating patients with Clostridium difficile got spores on their hands.

Part of the solution is to make sure healthcare workers get better training on how to put on their gowns and gloves, and how to take them off, the study authors wrote. But training can do only so much.

Perhaps workers should disinfect their gowns and gloves before they take them off, either with bleach or possibly ultraviolet C light.

Ultimately, the best solution may be to redesign personal protective equipment so that it’s easier to remove without contaminating oneself, the study authors wrote.

That won’t happen overnight, but some improvements might be easy to make. For instance, hospitals could provide gowns in a variety of sizes instead of relying on a one-size-fits-all approach. The researchers noted that in their observations, workers who were either petite, tall or large had more trouble removing their gowns safely. Visit the Los Angeles Times for the article.