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Copyright © 2012

People, Places, Processes & Products that Influence the Supply Chain

 

hpnonline Daily Update

2013
January 23-27, 2012
 
January 23 January 24 January 25 January 26 January 27
 

January 27, 2012   Download print version

Iodinated contrast media heart scans linked to thyroid disease

Study of freakish mystery illness finds no cause

New saliva test for infertile women could replace blood tests

Patti Koncur named IAHCSMM Educational Specialist

Survival’s ick factor

PMD Healthcare launches Spiro PD, the first personal spirometer to monitor lung function

Patients get half of preventive screens

Meth burn increase in U.S. hospitals, harmful effects on society


Iodinated contrast media heart scans linked to thyroid disease

A common iodinated contrast agent given to millions of patients who undergo medical scans every year raises the risk of thyroid disease, a new study shows. Iodide, a form of the chemical element iodine, is widely used as a radiocontrast agent to allow doctors to see blood vessels and tissues in medical imaging tests. In a typical year, about 80 million doses of iodinated contrast agents are administered worldwide, largely for CT scans, cardiac catheterizations and other angiograms, and their use is growing as the technology spreads to developing countries.

In the new study, the first large-scale look at whether the drugs can seriously affect thyroid function, scientists at Harvard Medical School and Brigham and Women’s Hospital examined data on a large group of people who were treated at Boston-area hospitals for various conditions and followed over a 20-year period. The researchers found that the people who went on to develop thyroid disease — either overactive or underactive thyroid — were two to three times as likely to have been injected with an iodide contrast agent than those who did not develop the disease.

“We were very surprised by the magnitude of the associations,” said Dr. Steven M. Brunelli, an assistant professor at Harvard Medical School and an author of the study, which was published in Archives of Internal Medicine. “We obviously expected to find something or we wouldn’t have embarked on the study. But to see these twofold or even threefold changes in risk was more than we had expected.”

It is well known that sudden exposure to high levels of iodide can disrupt thyroid function. But even though a typical dose of contrast agent contains 90 to several hundred times the recommended daily intake of iodide, there was little research looking at its effect on the thyroid. Most earlier studies were small or focused on allergic reactions and potentially toxic side effects on the kidneys.

The latest study involved nearly 2,000 people, some who were exposed to iodide contrast agents and some who were not. All of the patients had normal blood tests and normal thyroid function when the study began.

Over the next two decades, the researchers identified patients who developed thyroid problems. An overactive thyroid, or hyperthyroidism, can cause fatigue, restlessness and trouble concentrating. In the reverse situation, an abnormally low-functioning thyroid, or hypothyroidism, can lead to problems like depression, joint and muscle pain and weight gain.

Those with thyroid problems were compared with similarly matched control subjects to see if they had a greater likelihood of being exposed to an iodide contrast during medical imaging tests. The researchers found that people who developed severe hyperthyroidism were two and a half times as likely to have been injected with an iodide contrast agent. For those with severe hypothyroidism, the likelihood was three times as great.

The authors said that the increased risk of developing thyroid problems was especially concerning because the medications are so widely used. “Even a very modest risk would be a risk incurred by tens of millions of people with very real consequences,” Dr. Brunelli said. Visit the Archives of Internal Medicine for the study.

 

Study of freakish mystery illness finds no cause

Imagine having the feeling that tiny bugs are crawling on your body, that you have oozing sores and mysterious fibers sprouting from your skin. Sound like a horror movie? Well, at one point several years ago, government doctors were getting up to 20 calls a day from people saying they had such symptoms. The study appears in PLoS One.

Many of these people were in California and one of that state’s U.S. senators, Dianne Feinstein, asked for a scientific study. In 2008, federal health officials began to study people saying they were affected by this freakish condition called Morgellons. The study cost nearly $600,000. Its long-awaited results, released Wednesday, conclude that Morgellons exists only in the patients' minds.

"We found no infectious cause," said Mark Eberhard, a Centers for Disease Control and Prevention official who was part of the 15-member study team.

Sufferers of Morgellons (mor-GELL-uns) describe a variety of symptoms, including fatigue, erupting sores, crawling sensations on their skin and — perhaps worst of all — mysterious red, blue or black fibers that sprout from their skin. Some say they've suffered for decades, but the syndrome wasn't named until 2002, when “Morgellons” was chosen from a 1674 medical paper describing similar symptoms.

Afflicted patients have documented their suffering on websites and many have vainly searched for a doctor who believed them. Some doctors believe the condition is a form of delusional parasitosis, a psychosis in which people believe they are infected with parasites.

Last May, Mayo Clinic researchers published a study of 108 Morgellons patients and found none of them suffered from any unusual physical ailment. The study concluded that the sores on many of them were caused by their own scratching and picking at their skin.

The CDC study was meant to be broader, starting with a large population and then went looking for cases within the group. The intent was to give scientists a better idea of how common Morgellons actually is. They focused on more than 3 million people who lived in 13 counties in Northern California, a location chosen in part because all had health insurance through Kaiser Permanente of Northern California, which had a research arm that could assist in the project. Also, many of the anecdotal reports of Morgellons came from the area.

Culling through Kaiser patient records from July 2006 through June 2008, the team found — and was able to reach — 115 who had what sounded like Morgellons. Most were middle-aged white women. They were not clustered in any one spot. That led to the finding that Morgellons occurred in roughly 4 out of every 100,000 Kaiser enrollees. Roughly 100 agreed to at least answer survey questions, and about 40 consented to a battery of physical and psychological tests that stretched over several days.

Blood and urine tests and skin biopsies checked for dozens of infectious diseases, including fungus and bacteria that could cause some of the symptoms. The researchers found none that would explain the cases. There was no sign of an environmental cause, either, although researchers did not go to each person's house to look around.

They took fibers from 12 people, which were tested at the Armed Forces Institute of Pathology. Nothing unusual there, either. Cotton and nylon, mainly — not some kind of organism wriggling out of a patient’s body. Skin lesions were common, but researchers concluded most of them were from scratching. What stood out was how the patients did on the psychological exams. Though normal in most respects, they had more depression than the general public and were more obsessive about physical ailments, the study found.

However, they did not have an unusual history of psychiatric problems, according to their medical records. And the testing gave no clear indication of a delusional disorder.

So what do they have? The researchers don’t know. They don’t even know what to call it, opting for the label “unexplained dermopathy” in their paper.

But clearly, something made them miserable. “The absence of evidence is not evidence of absence,” said Felicia Goldstein, an Emory University neurology professor and study co-author. She said perhaps the patients could be helped by cognitive behavioral therapy that might help them deal with possible contributing psychological issues. The study is not expected to be the last word on the subject.

Among those with additional questions is Randy Wymore, an Oklahoma State University pharmacologist who for years was the most reputable scientist to look into it and who has concluded Morgellons is not a psychiatric disorder. Visit PLoS One for the article.

 

New saliva test for infertile women could replace blood tests

A new saliva test being rolled out by Boston IVF could save women undergoing infertility treatments from the pain and inconvenience of repeated blood tests to measure hormone levels. Normally, women undergoing in vitro fertilization have to get up to seven blood tests per cycle while they give themselves daily hormone injections to stimulate their egg production. The blood tests measure a form of estrogen called estradiol – also found in saliva – allowing women to adjust the dose of their hormone injections to avoid over-stimulating their ovaries, according to Boston IVF medical director Dr. Michael Alper.

The saliva test costs $150, the same as the blood test, said Alper, and should be covered by insurance in states like Massachusetts that mandate coverage for IVF.

Unfortunately, though, the saliva test can’t be done at home. Women still need to head to their doctor’s office every day or two to drop off the sample and get results later in the day.

Patients at the Waltham office of Boston IVF are now being offered the saliva test routinely and those in other locations, including Boston, will be offered the test starting in the next few weeks, said Alper. The test could see wider use in fertility centers across the country within the next year or two. Visit the Boston Herald for the article.

 

Patti Koncur named IAHCSMM Educational Specialist

The International Association of Healthcare Central Service Materiel Management has hired Patti Koncur, CRCST, CHMMC, ACE, a Central Sterile Supply veteran and longstanding active IAHCSMM member, to serve as the Association’s Educational Specialist.

Under the direction of IAHCSMM’s Educational Director, Natalie Lind, Koncur will assist in the development and implementation of professional educational programs, presentations, publications, and documents to advance IAHCSMM’s mission and education-focused goals. In addition, she will be responsible for addressing education-related questions from membership, vendors and others, as appropriate; assisting with Annual Conference planning; supporting educational offerings through attendance at the IAHCSMM Annual Conference; reviewing continuing education programs; authoring educational materials; facilitating work groups and committees on various educational projects; and serving as an educational speaker, among other duties.

Indeed, Koncur’s qualifications make her a good fit for the new role. She has more than 30 years experience in healthcare Central Sterile Supply, Materials Management and related fields, and most recently served as Corporate Director of Central Sterile Processing for a large health system, performing technical responsibilities for CSSDs within a multiple hospital complex. Additionally, she facilitated LEAN Six Sigma projects that spurred widespread departmental improvements, and provided ongoing technical support to all clinical areas within the health system. In addition to numerous other CSSD-related and clinical roles, Koncur also has 20 years consulting experience in the field of CSSD, Materials Management and Operating Room systems, and 15 years consulting for healthcare industry product development, pre- and post-release product validation.

Her experience with IAHCSMM is equally extensive. She is a former IAHCSMM Executive Board member and past President of IAHCSMM’s Southern California Chapter, and currently co-chairs IAHCSMM’s Professional Development Resource Committee. She assisted in the development of the Purdue/IAHCSMM Materials Management Certification Exam; was a contributing author and editor for the IAHCSMM Central Service Technical Manual, Seventh Edition, and the IAHCSMM Certified Healthcare Leadership Manual, second edition workbook and certification exam; and served as contributing author of IAHCSMM’s Self-Study Series. She is also a widely published author in trade and technical publications, and is a well-respected and -recognized speaker at IAHCSMM Annual Conferences and other meetings geared toward CSSD, Infection Prevention and Materials Management. Visit www.IAHCSMM.org.

 

Survival’s ick factor

Disgust is having its moment in the light as researchers find that it does more than cause that sick feeling in the stomach. It protects human beings from disease and parasites, and affects almost every aspect of human relations, from romance to politics. In several new books and a steady stream of research papers, scientists are exploring the evolution of disgust and its role in attitudes toward food, sexuality and other people.

Paul Rozin, a psychologist who is an emeritus professor at the University of Pennsylvania and a pioneer of modern disgust research, began researching it with a few collaborators in the 1980s, when disgust was far from the mainstream.

Speaking last week from a conference on disgust in Germany, Valerie Curtis, a self-described “disgustologist” from the London School of Hygiene and Tropical Medicine, described her favorite emotion as “incredibly important.” She continued: “It’s in our everyday life. It determines our hygiene behaviors. It determines how close we get to people. It determines who we’re going to kiss, who we’re going to mate with, who we’re going to sit next to. It determines the people that we shun, and that is something that we do a lot of.”  It begins early, she said: “Kids in the playground accuse other kids of having cooties. And it works, and people feel shame when disgust is turned on them.”

Some studies have suggested that political conservatives are more prone to disgust than liberals are. And it is clear that what people find disgusting they often find immoral, too. It adds to the popularity of disgust as a subject of basic research that it is easier to elicit in an ethical manner than anger or fear. You don’t have to insult someone or make anyone afraid for his or her life — a bad smell will do the trick. And disgust has been relatively easy to locate in the brain, where it frequents the insula, the amygdala and other regions.

And the research may have practical benefits, including clues to obsessive compulsive disorder, some aspects of which — like excessive hand washing — look like disgust gone wild.

Conversely, some researchers are trying to inspire more disgust at dirt and germs to promote hand washing and improve public health. Dr. Curtis is involved in efforts in Africa, India and England to explore what she calls “the power of trying to gross people out.” One slogan that appeared to be effective in England in getting people to wash their hands before leaving a bathroom was “Don’t bring the toilet with you.”

It is generally accepted that disgust evolved partly to avoid putting bad things in the mouth, an idea already put forth when Dr. Rozin tackled disgust. He and his colleagues developed the idea that disgust was then elaborated by cultural evolution to include other forms, one of them based in a dislike for reminders of the animal nature of humans. Sex, death, feces and bad food all smacked of animality.

Under that evolutionary umbrella, however, there is still the question of what kinds of disgust there are. Dr. Jonathan Haidt of the University of Virginia, Dr. Rozin and Clark McCauley of Bryn Mawr College claim nine different domains of disgust for North Americans. Dr. Curtis proposes seven categories. Joshua Tybur of VU University in Amsterdam proposed three domains of disgust, three separate psychological programs, for disease avoidance, mate choice and moral judgment.

Researchers have also been trying to pin down details about the mechanisms and evolutionary value of disgust. Daniel Fessler, an anthropologist at the Center for Behavior, Evolution and Culture at the University of California, Los Angeles, investigated with his colleagues why pregnant women were more sensitive to disgust. What they found was that as progesterone levels went up, so did sensitivity to disgust. That was true in the first trimester of pregnancy, when derailing fetal development would have the most dire effects. In very recent work, Dr. Fessler said, the researchers found that even in women who weren’t pregnant and were not suffering nausea, disgust increased with the levels of progesterone.

An important function of progesterone, Dr. Fessler said, is that it dials down an early-warning part of the immune system, inflammation, which might prevent the embryo, or conceptus, from implanting itself in the placenta. The eight-cell embryo “actually destroys tissue as it burrows in,” Dr. Fessler said. “Left to its own, the maternal immune system would destroy the conceptus.” So, he and his colleagues reason, while the body turns down the dial on one kind of protection, it turns it up on disgust, another kind of defense.

Whatever the fine points of disgust, its power to affect behavior is unquestioned, and that power ought to be put to good use, Dr. Curtis said. So, in one of her projects, she has worked with an Indian public relations agency to come up with a disgust-based campaign to encourage hand washing among mothers in small villages, which could save countless children’s lives lost to diarrhea and other diseases.

The result, now being tested, is a skit involving two characters, one a supermom and the other a disgusting, dirty man. The man makes sweets using mud and worms, stops in the middle of the performance to rush off because he has diarrhea, never washes his hands and does everything possible to be revolting. Supermom is scrupulously clean. Her children don’t get sick, the skit makes clear. In fact, her baby grows up to be a doctor. She washes her hands all the time. Visit the New York Times for the article.

 

PMD Healthcare launches Spiro PD, the first personal spirometer to monitor lung function

PMD Healthcare Inc., announced the launch and availability of its new lung health monitoring device – Spiro PD. Recently cleared by the FDA, Spiro PD is the first personal spirometer that enables patients with lung diseases – those with asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and lung transplants – to easily and accurately monitor their lung function anytime and anywhere. 

The easy-to-use device is designed specifically to monitor lung function of an adult, adolescent or young child. Other features of Spiro PD allow patients to view their lung function trends over time, manage medications, set reminder alarms to take medicine, do breathing exercises and quickly upload data to their computer and share it with their doctor.

Lung, or pulmonary, disease is any disease or disorder that occurs in the lungs or that causes the lungs to not work properly. Regular measurement and monitoring of lung function is important to pulmonary disease management. For more information visit www.spiropd.com

 

Patients get half of preventive screens

U.S. patients receive half of recommended preventive health services at an annual check-up by their doctors, researchers found. A team of researchers – led by Jennifer Elston Lafata of the Cancer Prevention and Control program at Virginia Commonwealth University Massey Cancer Center, and colleagues – found 46 percent of eligible and due services were missed during periodic health examinations.

Data came from audio recordings of 484 periodic health examination visits to 64 general internal medicine and family physicians in southeast Michigan for 19 guideline-recommended preventive services.

The study, published in the American Journal of Preventive Medicine, found the services most likely to be delivered were screenings for colorectal cancer, hypertension and breast cancer, but patients were least likely to receive counseling about aspirin use, vision screening and an influenza immunization recommended or delivered.

“It appears that while some preventive services are likely to be received by some patients, several services which are known to reduce disease go undelivered during routine periodic health examinations,” Elston Lafata said in a statement. “Relying on face-to-face interactions between physicians and patients will likely continue to result in less-than-optimal service delivery.”

Technological advances that provide patients with easy access to their personal health records, coupled with automated reminders, may be one way patients can work with physicians to increase delivery of preventive services, Elston Lafata said. (UPI) Read more here.

 

Meth burn increase in U.S. hospitals, harmful effects on society

The Associated Press has released a report on a survey conducted which showed that methamphetamine burn victims are overwhelming U.S. hospitals in the nation’s “most active meth states.” According to the analysis, hospitals are filled with uninsured burn patients, and this trend has become burdensome financially. Many of those injured received their wounds when making meth. Statistics cited by AP included $130,000 for an average meth patient’s hospital stay, and another figure cited was a cost of $6,000 per day for treatment of meth-burn patients. Furthermore, several burn units have reportedly closed, partially due to the inability to handle the load of expenses incurred.

Often the bottles and tubes associated with mobile meth labs are within close vicinity to the person making the drug and if it explodes or catches fire, the risk of personal injury is high. Some meth-makers have been caught carrying a mobile lab underneath a jacket.

In 2010 the Kalamazoo Gazette published an article that referred to a study (AP also included these Kalamazoo findings in their survey), which showed not only does the person making the illegal concoction get injured, but hospitals and taxpayers also suffer due to these actions.

Dr. Paul Blostein was one of the authors of a five-year study that examined this issue. Findings of patients analyzed at the Trauma and Emergency Center at Bronson Methodist Hospital in Kalamazoo often experienced internal injuries that affected breathing; many needed a ventilator to breathe after doing severe damage to lungs and windpipe. Chemical burns and vapors also cause other health issues.

The U.S. Justice Department states, “Cooking meth is relatively simple, but highly dangerous and toxic.” Unlike plant-derived drugs, meth cooking creates toxic gasses.

Additionally, meth-burn patients were prone to other health complications such as kidney problems, ulcers and pneumonia.

“Meth wasn’t even in the picture 10 years ago,” Bronson’s trauma program manager Rita Cox had said. “Now it is always considered when someone comes in. We have to have meth in the front of our minds to prepare ourselves for the additional resources these patients require.”

The involvement of meth skyrockets the cost of hospital stays after a burn. The Kalamazoo study compared meth patients versus non-meth related patients with similar types of burns, and the difference was about $43,000 higher for meth-related burns. Blostein said this didn't account for "doctor bills, or the follow-up plastic surgery or physical and occupational therapy" that is often needed post-hospitalization.

Additionally, as the AP story discusses, many meth patients lie about how they obtained their injuries, which indicates the dollar costs might even be higher; experts say it is impossible to get an accurate account. Currently the estimate is one-third of patients in hospitals are meth-related. Visit the Digital Journal for the article.

 


January 26, 2012   Download print version

In rating pain, women are the more sensitive sex

No flu shots for most late-thirtysomethings during swine flu outbreak

Healthcare delivery to be analyzed as U.S. agency expands view

Technology that predicts disease spread in mass gatherings

Jury: Hospital must pay Garth Brooks $1M for not building women’s center to honor his mom

Obama says healthcare jobs will be hard to create

CDC launches electronic antibiotic tracking system

Avastin, Sutent increase breast cancer stem cells, U-M study shows


In rating pain, women are the more sensitive sex

It has long been known that certain pain-related conditions, like fibromyalgia, migraine and irritable bowel syndrome, are more common in women than in men. And chronic pain after childbirth is surprisingly common; the Institute of Medicine recently found that 18 percent of women who have Caesarean deliveries and 10 percent who have vaginal deliveries report still being in pain a year later.

But new research from Stanford University suggests that even when men and women have the same condition — whether it’s a back problem, arthritis or a sinus infection — women appear to suffer more from the pain.

There is an epidemic of chronic pain: Last year, the Institute of Medicine estimated that it afflicts 116 million Americans, far more than previously believed. But these latest findings, believed to be the largest study ever to compare pain levels in men and women, raise new questions about whether women are shouldering a disproportionate burden of chronic pain and suggest a need for more gender-specific pain research.

The study, published Monday in The Journal of Pain, analyzes data from the electronic medical records of 11,000 patients whose pain scores were recorded as a routine part of their care. (To obtain pain scores, doctors ask patients to describe their pain on a scale from 0, for no pain, to 10, “worst pain imaginable.”)

For 21 of 22 ailments with sample sizes large enough to make a meaningful comparison, the researchers found that women reported higher levels of pain than men. For back pain, women reported a score of 6.03, men 5.53. For joint and inflammatory pain, it was women 6.00, men 4.93. Women reported significantly higher pain levels with diabetes, hypertension, ankle injuries and even sinus infections.

For several diagnoses, women’s average pain score was at least one point higher than men’s, which is considered a clinically meaningful difference. Over all, their pain levels were about 20 percent higher than men’s.

Unfortunately, the data don’t offer any clues as to why women report higher pain levels. One possibility is that men have been socialized to be more stoic, so they underreport pain. But the study’s senior author, Dr. Atul Butte, an associate professor at Stanford’s medical school, said that explanation probably did not account for the gender gap.

“While you can imagine such a bias,” he said, “across studies, across thousands of patients, it’s hard to believe men are like this. You have to think about biological causes for the difference.”

An extensive 2007 report by the International Association for the Study of Pain cited studies showing that sex hormones may play a role in pain response. In fact, some of the gender differences, particularly regarding headache and abdominal pain, begin to diminish after women reach menopause.

Research also suggests that men and women have different responses to anesthesia and pain drugs, reporting different levels of efficacy and side effects. That bolsters the idea that men and women experience pain differently.

One reason for the lack of information about sex differences is that many pain studies, in both animals and humans, are done only in males. One analysis found that 79 percent of the animal studies published in a pain journal over a decade included only male subjects, compared with 8 percent that used only female animals. In addition, experiments testing pain in men and women have shown that they typically have different thresholds for various types of pain. In general, women report higher levels of pain from pressure and electrical stimulation, and less pain when the source is from heat.

Melanie Thernstrom, a patient representative on the Institute of Medicine pain committee from Vancouver, WA, said the newest research “really highlights the need for more treatment and better treatment that is gender-specific, and the need for far more research to really understand why women’s brains process pain differently than men.” Visit the New York Times for the article.

 

No flu shots for most late-thirtysomethings during swine flu outbreak

Flu season may be a few months old, but peak season is yet to come. And new research has found that a large number of people at risk may still be refusing to protect themselves. Flu normally hits hardest in January or February, and infectious disease specialists say so far, this season has been very mild. But there are reports that nine people have died from swine flu this season in Mexico – where the first swine flu outbreak began back in 2009, ultimately claiming 17,000 lives worldwide.

Despite knowing how potentially deadly swine flu could be, a new report has found that only 20 percent of adults in their late 30s said they got a flu shot during the 2009 outbreak. In a survey, researchers from the University of Michigan asked approximately 3,000 adults between the ages of 36 and 39 – members of the age group known as Generation X – questions about how they responded to the 2009 swine flu pandemic, such as how they kept informed about the illness and whether they got flu shots to protect themselves or their family members.

The researchers have been following this same group of people for 25 years, and every year they survey them about their attitudes and behaviors related to different issues. Their work is known as the Longitudinal Study of American Youth (LSAY). According to the latest results delving into attitudes about the flu vaccine, only 1 in 5 adults got a flu shot, but nearly 65 percent said they were moderately concerned about the swine flu, and about 60 percent said they kept informed about it.

“This was the first epidemic that was relevant to this age group,” said Jon Miller, director of LSAY at the University of Michigan. “We were interested in how they used their prior science knowledge and prior education to make sense of this thing.” Adults in this age group, he explained, are very adept at gathering information from a variety of sources, including newspapers, magazines, online and from family, friends and colleagues. While they managed to stay abreast of what was happening with the disease outbreak, the majority of them did not get flu shots. Though a larger number of the cohort with young children at home did get the flu shot to prevent the swine flu.

Miller added the researchers did not ask the survey participants why they didn’t get vaccinated, but he and other experts say a number of factors likely came into play. One reason is because supplies were limited for some time during that flu season.

Despite their increased vulnerablity, adults in their late 30s may have been confused by changing public health messages about who should be vaccinated.

Another reason many late-thirtysomethings didn’t get flu shots despite their knowledge of the risks posed by swine flu is that they often display a trait well-known in adolescents.

“A lot of people have not matured as quickly as we would hope and one of the issues that is prevalent in adolescents and many adults is a certain level of belief that they are omnipotent and more powerful than things out there.” Miller hopes the study’s findings can shed some light on better ways to reach out to Generation Xers when it comes to preparing for future epidemics. Visit ABC News for the article.

 

Healthcare delivery to be analyzed as U.S. agency expands view

A U.S. agency formed to compare the effectiveness of drugs and medical devices plans a broader agenda that also will study subjects such as whether care provided by nurse-practitioners is as good as that of doctors. The agency, called the Patient-Centered Outcomes Research Institute, was created by the 2010 healthcare legislation. Republican opponents of the law say the institute will lead to government-directed rationing as it judges treatments.

The agency may spend as much as $2.5 billion on research through 2019, the Congressional Budget Office estimates. Comparing treatments will be one of five broad areas the agency plans to explore, its leaders said. Other research priorities include treatment disparities among people of differing races, gender and other characteristics; health-care systems, including the quality of care provided by nurses and physician’s assistants; how to communicate the best care options to patients and doctors and shortening delays between lab discoveries and their clinical use.

“It is by design a very, very broad set of priorities,” Carolyn Clancy, the director of the U.S. Agency for Healthcare Research and Quality and board member of the new institute, said Jan. 18 at a meeting in Jacksonville, FL.

The institute plans to announce an initial round of about 40 grants, drawn from 856 applications, in March. (Bloomberg News) Visit the Salt Lake Tribune for the article.

 

Technology that predicts disease spread in mass gatherings

Hosts of mass gatherings (MGs) could benefit from new opportunities that would assist in the preparation and response to threats of infectious diseases, as revealed by the fifth paper on MGs health in The Lancet Infectious Diseases Series. One of these opportunities would be to couple surveillance systems that use the Internet to identify outbreaks of infectious diseases around the globe in near real-time with a novel technology, which can track and predict global population movements through commercial air travel. The authors have described an analysis of potential threats to the 2012 Olympic Games using this novel approach.

Lead author, Kamran Khan from St Michael’s Hospital in Toronto, Canada explains: “An integrated platform of this kind could help identify infectious disease outbreaks around the world that could threaten the success of MGs at the earliest possible stages, provide insights into which of those outbreaks are most likely to result in disease spread into the MG, and identify the most effective public health measures to mitigate the risk of disease importation and local spread, all in near real-time.”

The Global Public Health Intelligence Network (GPHIN) and HealthMap are novel disease surveillance tools that use informal internet data sources like online news outlets, in order to detect early reports of disease outbreaks and for monitoring global disease activity. In contrast to traditional surveillance systems, i.e. government reports, which can be subject to delays in reporting and poor sensitivity, the novel surveillance tools have the potential to overcome these limitations.

Furthermore, the authors comment that understanding global air travel patterns before, during and after MGs are vital, given that this is the main mode of transport to and from MGs, and refer to Bio.Diaspora, a novel technology that can track worldwide air travel patterns to predict the worldwide spread of infectious diseases.

The system can be utilized to predict the amount of travelers, as well as their global origins from MGs. Therefore, in areas where large population movements to the MG host city are expected, the system is able to direct disease surveillance activities to specific global locations.

By applying this method, Khan and his team discovered that the vast majority of passengers traveling to Vancouver for the 2010 Winter Olympic Games originated from only 25 cities. Consequently, the real-time infectious disease surveillance efforts were then aimed on those particular cities to monitor and evaluate potential threats before, during, and immediately after the Games.

The fifth paper in this series describes how this method will be applied for the first time in London at the 2012 Olympic Games, for real risk assessment and planning purposes. It will assist UK public health officials in prioritizing which global outbreaks require the greatest attention at the time of the Games. Visit Medical News Today for the article.

 

Jury: Hospital must pay Garth Brooks $1M for not building women’s center to honor his mom

CLAREMORE, OK — An Oklahoma hospital in Garth Brooks’ hometown must pay $1 million to the country singer because it failed to build a women’s health center in honor of his late mother, jurors ruled Tuesday evening. Jurors ruled that the hospital must return a $500,000 donation to Brooks plus pay him $500,000 in punitive damages in Brooks’ breach-of-contract lawsuit against Integris Canadian Valley Regional Hospital in Yukon. Brooks said he thought he’d reached a deal in 2005 with the hospital’s president, James Moore, but sued after learning the hospital wanted to use the money for other construction projects.

The hospital argued that Brooks gave it unrestricted access to the $500,000 donation and only later asked that it build a women’s center and name it after his mother, Colleen Brooks, who died of cancer in 1999.

During the trial, Brooks testified that he thought he had a solid agreement with Moore. Brooks said the hospital president initially suggested putting his mother’s name on an intensive care unit, and when Brooks said that wouldn’t fit her image, Moore suggested a women’s center.

“This case is about promises: promises made and promises broken,” lawyer John Hickey told jurors shortly before they started deliberating. “Mr. Brooks kept his promise. Integris never intended to keep their promise and never built a new women’s center.”

But hospital attorney Terry Thomas said Brooks’ gift initially came in anonymously and unrestricted in 2005. He also noted that Brooks couldn’t remember key details of negotiations with the hospital’s president — including what he’d been promised — when questioned during a deposition after filing his lawsuit in 2009. (Associated Press) Visit the Washington Post for the article.

 

Obama says healthcare jobs will be hard to create

In his State of the Union address that barely mentions healthcare, President Obama hits on the message heard repeatedly from the healthcare industry: If you want more jobs, don’t cut off federal funding. Obama implores Congress not to “gut” investments in research, so American can maintain its spot as a world leader in medical innovation. That line will earn applause from the pharmaceutical and medical device industries, but it won’t be enough to deliver a health care economy that delivers a “fair shot” to everyone.

The president held out the continued possibility of saving healthcare costs with Medicare reform. “As I told the speaker this summer, I’m prepared to make more reforms that rein in the long term costs of Medicare and Medicaid, and strengthen Social Security, so long as those programs remain a guarantee of security for seniors,” Obama said. “But in return, we need to change our tax code so that people like me, and an awful lot of members of Congress, pay our fair share of taxes. Tax reform should follow the ‘Buffett Rule’:  If you make more than $1 million a year, you should not pay less than 30 percent in taxes.”

And he rebutted Republican accusations that his signature 2010 health reform law amounts to socialized medicine. “I’m a Democrat. But I believe what Republican Abraham Lincoln believed: That government should do for people only what they cannot do better by themselves, and no more,” he said. “That’s why our healthcare law relies on a reformed private market, not a government program.”

Obama makes it clear that he sees the giant healthcare sector as a place ripe for jobs growth. The American Association of Medical Colleges projects a shortage of 90,000 doctors over the next 10 years. It’s more than double that for the nursing industry, where the American Nursing Association sees a potential shortage of 260,000 nurses by 2025. These shortfalls will only be worsened as an additional 30 million people get health insurance under the 2010 health reform law.

But a national workforce commission established under the healthcare law has been chronically underfunded by Congress. The training programs that will be needed to fix these shortages have a slim to little chance of getting any funds. Appropriators have no room to give precious federal dollars to new programs while they are slashing old sacred cows in the austere spending environment that has reigned on Capitol Hill since Republicans took the House in 2011.

And while investments in research are nice, what medical device companies want even more is for Congress to take back a $20 billion tax it imposed on the industry to help cover the cost of the health reform law. Stephen Ubl, president of Advamed, a medical device lobbying association, says the tax is already causing layoffs.

Obama doesn’t get a break from hospitals either. The American Hospital Association says a coming 2 percent cut to Medicare and other cuts will cost them 278,000 jobs as revenue drops from Medicare and Medicaid. In the health care world, federal funds are the spigot for job creation, and no State of the Union speech is going to change the spending environment on Capitol Hill. Visit the National Journal for the article.

 

CDC launches electronic antibiotic tracking system

The Centers for Disease Control and Prevention (CDC) recently launched a new electronic antibiotic tracking system allowing hospitals to make better decisions about how to improve antibiotic use and compare themselves to other hospitals. Previously this tracking was only available in doctors offices. The tracking system is part of the CDC’s National Healthcare Safety Network. Any hospital that participates in the National Healthcare Safety Network can use this tool by working directly with its pharmacy software vendor to transmit data electronically from drug administration or barcoding records. There is no manual data entry, thus saving a facility time and money.

In conjunction with Get Smart About Antibiotics Week, the CDC has announced a partnership with the Institute for Healthcare Improvement to pilot-test a tool to help hospitals implement practical strategies to improve antibiotic use. The pilot testing is currently under way in eight U.S. hospitals. Visit AORN for the article.

 

Avastin, Sutent increase breast cancer stem cells, U-M study shows

Cancer treatments designed to block the growth of blood vessels were found to increase the number of cancer stem cells in breast tumors in mice, suggesting a possible explanation for why these drugs don’t lead to longer survival, according to a new study by researchers at the University of Michigan Comprehensive Cancer Center. Results of the study appear online in the Proceedings of the National Academy of Sciences Early Edition.

The drugs Avastin and Sutent have been looked at as potential breast cancer treatments. But while they do shrink tumors and slow the time till the cancer progresses, the effect does not last, and the cancer eventually regrows and spreads.

“This study provides an explanation for the clinical trial results demonstrating that in women with breast cancer antiangiogenic agents such as Avastin delay the time to tumor recurrence but do not affect patient survival. If our results apply to the clinic, it suggests that in order to be effective, these agents will need to be combined with cancer stem cell inhibitors, an approach now being explored in the laboratory,” says study author Max S. Wicha, M.D., director of the U-M Comprehensive Cancer Center.

The FDA recently revoked approval of Avastin for treating breast cancer, although the drug is approved for use in other types of cancer. The reversal was in response to clinical trials showing that the drug’s benefit was short-lived, with breast cancer patients quickly relapsing and the cancer becoming more invasive and spreading further throughout the body. Overall, the drug did not help patients live any longer.

The current study suggests the possibility of combining anti-angiogenesis drugs with a cancer stem cell inhibitor to enhance the benefit of this treatment. The researchers are testing this approach in mice and preliminary data looks promising. Visit UM for the article.

 


January 25, 2012   Download print version

Drug seen to curtail cancer left in prostate

Patients' tremors stopped after new non-invasive, pain-free brain surgery

AAMI invites comments on CMS maintenance announcement

Baby deaths traced to hospital neo-natal unit taps

Hospitals offer patients free parking, discount shopping, seminars and screenings

HealthGrades names top cities for hospital care

New genetic clues to breast cancer?

Nestlé Health Science launches next generation enteral safety technology


Drug seen to curtail cancer left in prostate

Fewer than 10 percent of the 100,000 men each year who get a diagnosis of early-stage prostate cancer and have the option of leaving the cancer in place while watching it actually do so. The rest want to just get rid of it, with surgery or radiation. But those treatments can have serious side effects like impotence and incontinence. Now a new study suggests there may be a way to slow or stop the cancer’s progress in those who choose not to be treated immediately.

The study, published on Monday in The Lancet, involved a drug, dutasteride, that is marketed to shrink prostates when they enlarge as men grow older. Two previous studies suggested that dutasteride and a similar drug, finasteride, could actually protect men from prostate cancer, but the Food and Drug Administration declined requests to allow the drugs to be marketed for cancer prevention, citing concerns that they may protect against early cancers but spur the growth of dangerous later-stage ones.

In the new study, led by Dr. Neil. E. Fleshner of the University of Toronto, men with early-stage prostate cancer were randomly assigned to take dutasteride or a placebo while being monitored for progression of the disease, but not treated, an approach known as active surveillance. Three years later, the cancer had progressed in 54 men in the dutasteride group, or 38 percent, and in 70 men in the placebo group, or 48 percent.

But the study had limitations. It was small, and three years is a short time for a cancer that tends to progress over many years. And even though the patients and their doctors were not told who was taking the drug and who was taking the placebo, it was easy to figure out. Dutasteride slashes levels of prostate specific antigen, or P.S.A., in half. And blood tests for P.S.A. are part of active surveillance as well as the way most men first learn they have the cancer.

The evidence that dutasteride might be slowing or stopping the growth of prostate cancers or even shrinking the tumors came from biopsies of the study subjects. Prostate biopsies of those taking dutasteride were less likely to find cancer than biopsies of men who were taking the placebo. That result is consistent with the results of the previous studies suggesting dutasteride might prevent cancer, noted Dr. Ian Thompson, a prostate cancer expert at the University of Texas Health Science Center at San Antonio, who was not associated with the study. Visit the New York Times for the article.

 

Patients' tremors stopped after new non-invasive, pain-free brain surgery

Patients diagnosed with essential tremors, a neurological disorder that causes patients to lose control of their hands, heads and voices, can make them desperate for help. An estimated 10 million Americans suffer from the disorder. Dr. Jeff Elias, associate professor of neurology at the University of Virginia, and his team have begun a clinical trial for patients suffering from essential tremors -- using a technique stripped right from a scene in a science fiction movie. Elias’ plan is to use ultrasound waves, focused to a specific point located by using an MRI machine, to treat the part of the brain that was causing the shaking.

"We're able to focus these 1,024 ultrasound beams to a single point and -- treat or -- or disrupt a lot of the tremor cells that are causing the problem," he said. "Essentially tremor's a neuro-degenerative problem, like Parkinson's disease. And it probably develops from an abnormal circuitry in the brain. And we're able to treat that circuit and restore it to a more normal condition."

One patient accepted into the trial, underwent the procedure in August 2011 for the shaking in her right hand. The results were immediately clear -- once the four-hour procedure had ended, her shaking had stopped. The doctors and nurses were able to test the patients while they were wide awake to make sure they were hitting the correct spot with the ultrasound waves.

"This M.R.I.-guided focused ultrasound allows us to actually visualize the entire treatment, while it's being delivered," said Elias. "And we still have the ability to interact with a patient and refine and polish the procedure."

The procedure was unique not only in that it could safely and immediately deliver results, but also because it's reportedly pain-free and there is virtually no recovery time. Patients were required to stay overnight in the hospital for observation, but both were able to walk, talk and perform tasks that they weren't able to in years after they left the MRI machine.

For Elias, a successful trial using focused ultrasound surgery is just the tip of the iceberg. "We could send ultrasound waves to almost any organ of the body. So cancers, strokes, Parkinson's disease, epilepsy. They're really all potentially treatable with this type of technology," he said.

For the people undergoing the procedure, their lives are completely changed in that they can finally live normal lives. Visit ABC News for the article.

 

AAMI invites comments on CMS maintenance announcement

The Association for the Advancement of Medical Instrumentation (AAMI) is inviting comments and recommendations from interested parties on a recent U.S. Centers for Medicare and Medicaid Services (CMS) announcement that manufacturer-recommended maintenance frequencies are required for all equipment critical to patient health and safety.

The comments, which can be submitted here, will be used to guide the next steps of an informal coalition of interested parties that was formed to discuss the Dec. 2 announcement, which was greeted with dismay by many hospital-based healthcare technology management professionals.

The announcement also calls for hospitals to follow manufacturer-recommended maintenance frequencies on any new equipment until a sufficient amount of maintenance history for that equipment has been acquired. And the announcement flatly rules out any alternatives to the manufacturer’s methods for maintaining equipment, “even if the hospitals alter the frequency of maintenance activities.”

The coalition includes various medical equipment users and others, including representatives from The Joint Commission (TJC), AAMI, ECRI Institute, and healthcare facilities. AAMI would like to know how affected parties would be impacted by the announcement. Specific data and/or examples encouraged in the comments.

The CMS announcement came in the form of a memo distributed to state survey agency directors and described as a “clarification of hospital equipment maintenance requirements.” It came about 18 months after TJC, the largest healthcare accrediting organization in the country, announced at the AAMI 2010 Annual Conference & Expo that CMS had accepted the organization’s approach of granting hospitals more leeway in setting their PM schedules.  The CMS “clarification” grants hospitals far less latitude with maintenance than what TJC had announced.

According to CMS, biomeds and clinical engineers can adjust the PM schedule for noncritical equipment by using strategies different from what the manufacturer recommends. But the hospital must create an evidence-based assessment that shows “the frequency adjustment will not adversely affect patient or staff health and safety.” The full CMS memorandum is available here (PDF).

 

Baby deaths traced to hospital neo-natal unit taps

A killer infection that claimed the lives of three babies in a Belfast hospital has been traced to taps in the neo-natal unit, Northern Ireland's health minister said. All the taps and connected pipe work in the room at the Royal Jubilee Maternity Hospital are to be removed as experts try to eradicate all traces of the pseudomonas bacteria, according to a spokesman. One baby continues to be treated amid as yet unconfirmed fears that the infant has also contracted the potentially deadly infection.

An outbreak of a different strain of pseudomonas in Londonderry's Altnagelvin hospital last month, which claimed the life of one baby, was also linked to the water system in its neo-natal facilities.

Royal Jubilee said special ultra violet technology may be installed in the region`s hospitals in a bid to prevent further outbreaks. The incident in Altnagelvin prompted health chiefs to write to all trusts in Northern Ireland reminding them of the infection risks posed by water systems.

The neo-natal unit at the Royal Jubilee, which was emptied in the wake of the outbreak, has undergone a deep clean. Pseudomonas can cause infections in the chest, blood and urinary tract. The minister said the baby with suspected pseudomonas had been struck down with pneumonia.

Of three other babies believed to have contracted the infection at the Royal Jubilee, two have recovered and continue to receive neonatal care, while the third initially recovered but subsequently died of unrelated causes. The six other babies were found to be carrying traces of the bacteria, for example on their skin, but had shown no signs they had contracted the infection.

The Chief Medical Officer said guidance was issued across the UK in 2010 to help avoid such infections, including the risks associated with taps and sinks. The guidance was reissued following the death in Altnagelvin. "If you look at outbreaks that occurred in other parts of the United Kingdom and across Europe and wider, there have been a variety of sources that have been identified ... There was a wide range of potential environmental sources and a wide range of potential for human transmission." Visit here for the article.

 

Hospitals offer patients free parking, discount shopping, seminars and screenings

Credit card companies, airlines and hotels all have customer loyalty programs. Maybe it was only a matter of time before hospitals got in on the act. A growing number of hospitals are seeking to attract new patients and keep existing ones by offering them an array of perks, from free parking and gift-shop discounts to wellness seminars and health screenings. Some of the most popular programs are social mixers that have nothing to do with healthcare. Field trip to a casino, anyone?

It’s all part of a changing competitive environment in which hospitals market themselves directly to patients, who have begun to take a much more active role in choosing their healthcare providers — and are on the hook for a greater share of the costs.

Before managed care, hospitals focused more on appealing to physicians with new and advanced medical technologies, experts say. Physicians, it was thought, would bring in the patients.

Changes in healthcare policies are giving hospitals added incentive to develop relationships with patients. Under the 2010 healthcare overhaul, hospitals with higher than expected 30-day readmission rates for heart attack, heart failure and pneumonia will face financial penalties starting this year. The number of conditions subject to penalty will be expanded in subsequent years, and hospitals can help themselves by working with patients before they land in the hospital with an acute problem.

“Hospitals will have an expanding share of risk in their patient populations going forward,” says Tony Paquin, chief executive of Paquin Healthcare, an Orlando consulting and technology firm that has worked with more than 150 hospitals to develop loyalty programs. “Healthcare providers are just starting to figure out that they need to develop patient relationships if they’re going to improve their health long term.”

Botsford Hospital in Farmington Hills, MI, started issuing free “Very Important Patient” cards in 2010. The program got its start as a referral service to link potential patients with Botsford doctors. The cards entitle VIP members to free parking and a 10 percent discount on nonprescription drugs at the outpatient pharmacy and the gift shop, says Lynn Anderson, marketing and public relations manager at the 330-bed hospital in the Detroit suburb. VIP members can also get discounts at restaurants and service establishments such as an oil-change garage. The program, which has more than 900 members, is open to anyone in the community. In addition to financial perks, it offers regular health education seminars on such topics as hip replacements, back problems and acid-reflux disease, says Anderson.

These sorts of marketing activities make sense, say experts. “Customers will go to a provider and judge the experience based on things that they can understand: good food, ease of parking, attentiveness, nice sheets,” says Paquin.

John Romley, a health economist at the University of Southern California who co-authored a recent article in the New England Journal of Medicine about the increasing importance of amenities in patient care, concurs. “Patient preferences about where they receive care seem to turn on creature comforts and amenities,” he says, rather than on healthcare-related measures such as complication or infection rates.

While there are no data to show that loyalty programs encourage patients to get unnecessary care, Romley says these marketing efforts are in some ways analogous to drugmakers’ controversial advertising that “reach[es] out directly to consumers in order to have them drive the medical decision-making to a degree and have them demand the expensive drug,” he says. Visit the Washington Post for the article.

 

HealthGrades names top cities for hospital care

HealthGrades has released a list of America's Top Cities for Hospital Care. The rankings are based on a comprehensive study of patient death and complication rates at the nation's nearly 5,000 hospitals. As part of its tenth annual HealthGrades Hospital Quality and Clinical Excellence study, HealthGrades identified those hospitals performing in the top 5% nationwide across 26 different medical procedures and diagnoses, then ranked cities by highest percentage of these Distinguished Hospitals for Clinical Excellence. 

Baltimore, MD ranked #1 in the nation, with nine top-performing hospitals out of 19 eligible hospitals. Rounding out the top ten markets for hospital care quality were: Phoenix-Prescott, AZ; Cedar Rapids, IA; Richmond, VA; Cincinnati, OH; West Palm Beach, FL; Chattanooga, TN; St. Louis, MO; Hartford-New Haven, CT; and Grand Rapids-Kalamazoo, MI respectively. The Top Cities for Hospital Care list is based on the percent of Distinguished Hospital for Clinical Excellence award recipients compared to the number that are eligible in that particular city.

In an environment where one in seven Medicare beneficiaries is harmed as a result of their hospitalization and patients are fearful of the very institutions that are entrusted with saving their lives, it is important to identify and acknowledge those hospitals that are leading the way in reducing mortality and complication rates and to provide consumers access to this information.

For the communities themselves, these hospitals have significant impact. In some instances, the top cities named in this report can make the claim that almost half of their hospitals provide this level of care including: Baltimore (47%), Phoenix-Prescott (44%), Cedar Rapids (43%), and Richmond, VA (43%).

Other key findings from the study include:

Distinguished Hospitals can be found in 38 states. The top cities for hospital quality, determined by having the most Distinguished Hospitals in a Designated Market Area (DMA), are found in 26 states. 

Specifically, Distinguished Hospitals for Clinical Excellence had a 30.07% lower risk-adjusted mortality rate and a 1.86% lower risk-adjusted inhospital complication rate among Medicare beneficiaries compared to all other hospitals.

In fact, if all hospitals performed at the level of Distinguished Hospitals for Clinical Excellence, 165,704 Medicare lives could potentially have been saved and 6,800 Medicare inhospital complications could potentially have been avoided. More information on how HealthGrades guides Americans to their best health can be found at www.healthgrades.com.

 

New genetic clues to breast cancer?

Researchers have identified three new genomic regions they believe are linked with breast cancer that may help explain why some women develop the disease. All three newly identified areas "contain interesting genes that open up new avenues for biological and clinical research," said researcher Douglas Easton, a professor of genetic epidemiology at the University of Cambridge in England.

Scientists conducting genome-wide association studies -- research that looks at the association between genetic factors and disease to pinpoint possible causes -- had already identified 22 breast cancer susceptibility loci. Locus is the physical location of a gene or DNA sequence on a chromosome.

"The three [newly identified] loci take the number of common susceptibility loci from 22 to 25," said Easton.

However, the three new susceptibility loci might explain only about 0.7 percent of the familial risks of breast cancer, bringing the total contribution to about 9 percent, the researchers said.

Michael Melner, scientific program director for the American Cancer Society, said this current research adds some important new clues to existing evidence, but he agreed that the number of cases likely associated with these three variants is probably low.

The study is published online Jan. 22 in Nature Genetics.

To find the new clues, Easton's team worked with genetic information on about 57,000 breast cancer patients and 58,000 healthy women obtained from two genome-wide association studies. The investigators zeroed in on 72 different single nucleotide polymorphisms (SNPs). A SNP -- pronounced "snip" -- is a change in which a single base in the DNA differs from the usual base. The human genome has millions of SNPs, some linked with disease, while others are normal variations. The researchers focused on three SNPs -- on chromosomes 12p11, 12q24 and 21q21.

Easton's team found that the variant on the 12p11 chromosome is linked with both estrogen receptor-positive breast cancer (which needs estrogen to grow) and estrogen receptor-negative breast cancer. The other two variants are only linked with ER-positive cancers, they said.

One of the newly identified variants is in an area with a gene that has a role in the development of mammary glands and bones. Easton said it was already known that mammary gland development in puberty is an important period in terms of determining later cancer risk. "But these are the first susceptibility genes to be shown to be involved in this process," he said. One of the other SNPs is in an area that can affect estrogen receptor signaling, the researchers found.

Melner, noting some of the research is "fine tuning" of other work, said in his view the new understanding of the signaling pathways and their genetic links is the most important finding. Overall, Melner added, the results underscore the complexity of the different mechanisms involved in breast cancer development. (HealthDay) Visit NIH for the study.

 

Nestlé Health Science launches next generation enteral safety technology

Nestlé Health Science will unveil its pediatric closed system formulas with the new SpikeRight PLUS port at the annual American Society for Parenteral and Enteral Nutrition’s (A.S.P.E.N.) Clinical Nutrition Week meeting being held in Orlando January 21-24. The introduction marks a significant step in supporting the provision of safe enteral (tube) feeding.

Enteral tubing misconnections, where feeding solutions are wrongly administered through intravenous (IV) tubing or other non-enteral systems, have been a concern for nearly thirty years. Most commonly occurring in intensive care settings, where patients have multiple types of tubing connections, an enteral tubing misconnection can result in catastrophic complications and possibly death.

To help address this issue, Nestlé Health Science introduced its original SpikeRight design in the U.S. in 2008. The company’s unique design reduces the risk of proximal end (the end closest to the nutrition container) tubing misconnections. Now the next-generation design, the SpikeRight PLUS enteral connection system, helps to further reduce the risk of tubing misconnections through its PLUS (+) shape which is specifically designed to be incompatible with IV tubing sets, IV solution bags, and other types of non-enteral connectors. Currently, the SpikeRight PLUS system is available for pediatric tube feeding products. Additional Nestlé Health Science products with the SpikeRight PLUS port will be available in North America in the coming months.

The issue of tubing misconnections is a global concern. Currently, the International Organization for Standardization (ISO) is working together with government and industry representatives, including Nestlé Health Science, to bring a global standard for enteral nutrition connections to the marketplace. The SpikeRight PLUS design has been proposed as the sole industry standard for the proximal end and will undergo additional usability testing this month. A final standard is expected by 2014. Visit www.nestlenutrition.com/us.

 


January 24, 2012   Download print version

Catholic hospital chain cuts official church ties

Nominate an innovator, leader, pioneer for Bellwether Healthcare Supply Chain Hall Of Fame

AHA: Medicare cuts to cost 278K hospital jobs

Pay cap curbs cost of services: Executives limited to $199,000 in state-funded service providers

Cook Medical renews contract with Premier, extending price agreements on specialty urology products

VHA Inc. helps Memorial Hermann Healthcare System save $48.7 million in supply chain savings and VHA Door-to-Discharge

GAO releases report on prescription pain reliever abuse

UF researchers develop gene therapy that could correct a common form of blindness


Catholic hospital chain cuts official church ties

A major Catholic hospital chain has severed its official ties with the Roman Catholic Church as it seeks to maintain an unusual business model that includes both Catholic and non-Catholic hospitals. Catholic Healthcare West said Monday that it also was changing its name to Dignity Health as a part of the overhaul.

The San Francisco-based not-for-profit is seeking to expand beyond its base in California, Nevada and Arizona and wants to signal to potential partners that it is not exclusively a Catholic organization. At the same time, the chain said its 25 Catholic hospitals would continue to follow the Vatican’s official healthcare guidelines, which include restrictions on abortion and birth control.

Its 15 non-Catholic hospitals will continue to follow the chain’s “Statement of Common Values,” which also limit abortion and fertility treatments. (Associated Press) Visit the San Francisco Chronicle for the article.

 

Nominate an innovator, leader, pioneer for Bellwether Healthcare Supply Chain Hall Of Fame

The Bellwether League Inc.’s Board of Directors selects deceased, retired and currently active professionals with a minimum of 25 years of exemplary service and leadership performance in supply chain operations that meet its criteria to be publicly recognized. Honorees demonstrate their qualifications through advancing the profession, work experience, work performance and active participation in professional organizations.

This years deadline for nominations is Monday, February 13, 2012. Honorees will be inducted October 2, 2012, at its 5th Annual Honoree Induction, Dinner Event in Chicago.

·         Nominees represent five distinct categories: Education & Media, Supply Chain Management, Group Purchasing, Supplier and Consultant.

  1. Education & Media: College/university professors and researchers, publishers, editors and writers.

  2. Supply Chain Management: Professionals working at hospitals and other non-acute care facilities, hospital systems and integrated delivery organizations.

  3. Group Purchasing: Professionals from among the national, regional, state, metropolitan and local group purchasing programs.

  4. Supplier: Professionals employed by manufacturers and distributors of products and services purchased by healthcare providers.

  5. Consultant: Professionals that advise, instruct and motivate healthcare supply chain managers as the primary focus of their practice.

Visit www.bellwetherleague.org for more information or www.bellwetherleague.org/nominations.html for the official nomination form.

 

AHA: Medicare cuts to cost 278K hospital jobs

Hospitals should prepare themselves for nearly 278,000 job losses over the next decade because of a potential $61.4 billion in Medicare cuts, according to a new report from the American Hospital Association (AHA) and by economic research firm Tripp Umbach. Should Congress enact $20 billion in Medicare cuts included in legislation (H.R. 3630) already passed in the House, it will cost 83,000 jobs, according to the report.

The 83,000 job loss figure is coupled with an additional estimated 194,000 job losses through sequestration, slated to begin in 2013. Under the Budget Control Act of 2011, signed into law, Medicare will cut $41.5 billion in payments – that is, a 2 percent cut to payments to all providers – in each of the next nine years, the report noted.

H.R. 3630 would reduce payments for bad debts incurred by Medicare patients from 70 percent in most settings to 55 percent between 2013 and 2015, at an estimated $5.8 billion impact, according to the report. It also would cut payment rates for evaluation and management (E&M) services in hospital outpatient departments to physician office rates, estimated at $12.3 billion. In addition, the bill would place beneficiary caps on the use of outpatient therapy services, affecting an estimated $1.8 billion.

The Bureau of Labor Statistics this month reported overall healthcare employment is up with December gains of 22,600 healthcare jobs, with 9,800 of them at hospitals. Visit AHA for the article.

 

Pay cap curbs cost of services: Executives limited to $199,000 in state-funded service providers

ALBANY — A day after rolling out the idea as part of his budget proposal, Gov. Andrew Cuomo on Wednesday signed an executive order to rein in administrative costs and executive compensation packages at state-funded service providers. The order states that pay or other benefits of any executive working for a provider can draw no more than $199,000 annually from public funds. This change wouldn’t necessarily hand pay cuts to top administrators, though it does mean their employers would have to find a different money pool to draw from: If a hospital, for example, wanted to pay its CEO more, it could draw on private revenue or other non-public monies.

Hefty pay at state providers for the disabled was highlighted in a recent series of stories by The New York Times that found top executives pulling in millions in pay and additional benefits at companies funded in large part by state and federal dollars.

Cuomo’s order also requires that at least 75 percent of every public dollar should go to direct services and not administration. That percentage would tick up by 5 percent in the two subsequent years and top out at 85 percent.

“We must make sure that taxpayers’ dollars are always used efficiently and effectively to improve the lives of New Yorkers,” Cuomo said in a statement. “This executive order ... will ensure that taxpayer dollars are being used to help New Yorkers in need.”

The order gives state agencies 90 days to craft rules governing compensation for providers that receive state or state-approved funds, including the Department of Health and state offices for People with Developmental Disabilities, Mental Health, Children and Family Services, Temporary and Disability Assistance, and Aging.

Once those rules are established, failure to stay within them could result in a provider losing its state contract. Waivers could be granted by commissioners with the approval of the state budget director. Visit the Times Union for the article.  

 

Cook Medical renews contract with Premier, extending price agreements on specialty urology products

Hospitals around the country have three more years of access to a specialty urology agreement with an extensive line of specialty urology products at special pricing after Cook Medical and the Premier healthcare alliance renewed their contract to provide Cook’s urology products to more than 2,500 hospitals.

Premier’s renewed contract, beginning on Jan. 1, 2012, provides member hospitals with Cook’s line of endourological products, including Cook-exclusive products such as the Resonance Metallic Ureteral Stent, the NGage Nitinol Stone Extractor, and the Bigopsy Backloading Biopsy Forceps. Because of Cook’s technically advanced and broad line of products, the contract allows participating hospitals to primarily use one vendor for endourological product needs. Cook’s contracts reduce the need for hospitals to use multiple vendors, saving time and money when managing inventory. Cook has more than 25 products launched in the last six years for the endourology space. Visit Cook Medical for more information.

 

VHA Inc. helps Memorial Hermann Healthcare System save $48.7 million in supply chain savings and VHA Door-to-Discharge

Anticipating the effects of decreased reimbursements and revenues related to healthcare reform and the myriad regulatory pressures demanding cost reductions and improved patient outcomes, Memorial Hermann Healthcare System worked closely with VHA Inc., the national health care network, to save nearly $49 million in less than two years and help the system achieve its vision to be among the nation's best healthcare systems.

As one of Texas’ largest not-for-profit healthcare systems, serving southeast Texas and the greater Houston community, MHHS includes 13 hospitals and a vast network of affiliated physicians and specialty programs and services. Because one-third of Houston's residents are uninsured and 23% of the system’s volume is derived from self-pay and Medicaid patients, system leaders determined that at current operating costs, the organization would confront a $400 million gap between its actual patient care costs and reimbursements in the next five to seven years.

Working with VHA, MHHS implemented a Non-Salary Cost Reduction and VHA Door-to-Discharge Engagement to achieve transformational changes in day-to-day operations, reducing the overall cost of patient care while maintaining or improving quality.

VHA’s supply and clinical consultants worked with MHHS to implement more than 300 savings initiatives and improve all areas of cost from acquisition of supplies, purchased services, and capital, to utilization of supplies and clinical services. Additionally, these efforts promoted physician and clinician behavior changes and identified operational workflow and patient throughput improvements in several system hospitals. Visit here for the article.

 

GAO releases report on prescription pain reliever abuse

The Centers for Disease Control and Prevention has declared that the United States is in the midst of an epidemic of prescription drug overdose deaths, with deaths associated with prescription pain relievers of particular concern. To address this issue, federal agencies are raising awareness by educating prescribers and the general public. In response, GAO (Government Accountability Organization), interviewed officials and reviewed documents and websites from seven agencies involved in federal drug control efforts and analyzed the most recent data from several data sources related to prescription pain reliever abuse and misuse. GAO also assessed the development of public education efforts and federal coordination efforts against key practices from prior GAO work.

Key measures of prescription pain reliever abuse and misuse increased from 2003 to 2009. The largest increases were in measures of adverse health consequences such as emergency department visits, substance abuse treatment admissions, and unintentional overdose deaths, though increases were not consistent across all measures. Federal officials suggested that increasing availability of prescription pain relievers and high-risk behaviors by those who abuse or misuse the drugs, such as combining prescription pain relievers with other drugs or alcohol, likely contributed to the rise in adverse health consequences, though data about the reasons for the increases are limited.

The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Substance Abuse and Mental Health Services Administration (SAMHSA) use a variety of strategies to educate prescribers about issues related to prescription pain reliever abuse and misuse, but officials told us that more education is needed. The strategies used include developing continuing medical education programs, requiring training and certification in order to prescribe certain drugs, and developing curriculum resources for future prescribers. The Office of National Drug Control Policy (ONDCP) is working to develop a legislative proposal to require education for prescribers registering with the Drug Enforcement Administration (DEA) to prescribe controlled substances. Officials from some agencies said such a requirement would ensure all prescribers were starting from the same baseline of knowledge.

Among federal initiatives to educate prescribers and the public about prescription pain reliever abuse and misuse, GAO found several instances of agencies engaging in similar efforts, directed at similar target audiences and using similar mediums. Officials said that these similarities in public education efforts are beneficial in addressing prescription drug abuse and misuse because having multiple, reinforcing messages about the same subject is valuable in public health communications and because federal agencies provide slightly different perspectives on the issues surrounding prescription drug abuse and misuse.

Likewise, the prescriber education programs GAO identified, though similar, are different in content and focus. Though these similar programs have the potential to be duplicative if not effectively coordinated, federal agencies have recently begun to coordinate their educational efforts. Nevertheless, federal agencies have missed opportunities to share lessons learned and pool resources among similar education efforts.

GAO recommends that the Director of ONDCP establish outcome metrics and implement a plan to evaluate proposed educational efforts, and ensure that agencies share lessons learned among similar efforts. ONDCP did not explicitly agree or disagree with GAO’s recommendations, but noted that it will continue to work for improved coordination of educational efforts and evaluation of outcomes. In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should establish outcome metrics and identify resources for conducting outcome evaluations for the national education campaigns about prescription drug abuse and safe storage and disposal proposed in the Prescription Drug Abuse Prevention Plan. Visit GAO for the report.

 

UF researchers develop gene therapy that could correct a common form of blindness

A new gene therapy method developed by University of Florida researchers has the potential to treat a common form of blindness that strikes both youngsters and adults. The technique works by replacing a malfunctioning gene in the eye with a normal working copy that supplies a protein necessary for light-sensitive cells in the eye to function. The findings are published Monday, Jan. 23, in the Proceedings of the National Academy of Sciences online.

Several complex and costly steps remain before the gene therapy technique can be used in humans, but once at that stage, it has great potential to change lives. The researchers tackled a condition called X-linked retinitis pigmentosa, a genetic defect that is passed from mothers to sons. Girls carry the trait, but do not have the kind of vision loss seen among boys. About 100,000 people in the U.S. have a form of retinitis pigmentosa, which is characterized by initial loss of peripheral vision and night vision, which eventually progresses to tunnel vision, then blindness. In some cases, loss of sight coincides with the appearance of dark-colored areas on the usually orange-colored retina.

The UF researchers previously had success pioneering the use of gene therapy in clinical trials to reverse a form of blindness known as Leber’s congenital amaurosis. About 5 percent of people who have retinitis pigmentosa have this form, which affects the eye’s inner lining.

The X-linked form of retinitis pigmentosa addressed in the new study is the most common, and is caused by degeneration of light-sensitive cells in the eyes known as photoreceptor cells. It starts early in life, so though affected children are often born seeing, they gradually lose their vision.

The researchers plan to repeat their studies on a larger scale over a longer term, and make a version of the virus that proves to be safe in humans. Once that is achieved, a pharmaceutical grade of the virus would have to be produced and tested before moving into clinical trials in humans. The researchers will be able to use much of the technology they have already developed and used successfully to restore vision. Visit UF for the article.

 


January 23, 2012   Download print version

First link between potentially toxic PFCs in office air and in office workers’ blood

Survey: Facility managers and cleaning professionals willing to pay more for sustainable products

Justice Dept. asks court to reconsider bone marrow ruling

Chefs, butlers, marble baths: Hospitals vie for the affluent

House Democrats seek hearing on risks from J&J Mesh, Allergan Lap-Band

Man dies of bird flu in southwest China: Xinhua

Anti-infective drug shortages pose threat to public health and patient care

Healthcare services for all suffering from impact of Medicaid cuts


First link between potentially toxic PFCs in office air and in office workers’ blood

In a first-of-its-kind study, scientists are reporting that the indoor air in offices is an important source of worker exposure to potentially toxic substances released by carpeting, furniture, paint and other items. Their report, which documents a link between levels of these so-called polyfluorinated compounds (PFCs) in office air and in the blood of workers, appears in ACS' journal Environmental Science & Technology.

Michael McClean and colleagues explain that PFCs, used in water-repellent coatings on carpet and furniture, may have adverse effects on human health. The substances are widespread in the environment and in humans around the world. Scientists know that potential sources of exposure include food, water, indoor air, indoor dust and direct contact with PFC-containing objects. But the link between levels in air and blood had not been explored previously, so McClean's group set out to fill that gap with a study of 31 office workers in Boston.

They found concentrations of a PFC called fluorotelomer alcohol (FTOH) in office air that were 3-5 times higher than those reported in previous studies of household air, “suggesting that offices may represent a unique and important exposure environment.” In addition, the study found a strong link between concentrations of FTOH in office air and perfluorooctanoic acid (a metabolite of FTOH) in the blood of office workers. The results also suggested that workers in newly renovated office buildings may receive considerably higher doses of PFCs than workers in older buildings. Visit here for the article.

 

Survey: Facility managers and cleaning professionals willing to pay more for sustainable products

A survey conducted for The Sustainability Dashboard, a Web-based system that helps organizations measure and monitor their use of fuel, water, energy, etc., finds that 43 percent of facility managers and cleaning professionals would pay more for products made by a company that practices sustainability. However, 28 percent of respondents indicated they would not pay more and 30 percent were “not sure.”

The survey was conducted online in January 2012. Nearly 150 people participated in the survey. When asked, how much more are you willing to spend for a product produced by a sustainable company, 90 percent answered five to ten percent. The survey also asked if the respondents would need proof a company is practicing sustainability: seventy-eight percent responded yes; about ten percent would take the company’s “word for it;” and the rest were unsure.

Nevertheless, the respondents were divided on how this “proof” would be determined.  About 25 percent would accept the company’s published reports. “But, 57 percent wanted [the reports from] independent, third-party organizations and not just the company’s word for it,” said Elizabeth Steward, marketing manager for Sustainability Dashboard Tools.

Finally, the respondents were asked if operating a business or property in a more sustainable manner costs more, less, or about the same as operating in a conventional manner. Forty-one percent were sure sustainability produced cost savings; 27 percent noted it costs more; and the rest were unsure or believed it was “cost neutral.” For more information visit: www.green2sustainable.com.

 

Justice Dept. asks court to reconsider bone marrow ruling

The Obama administration has asked an appeals court to reconsider its decision that people who donate bone marrow can be paid for it. A three-judge panel of the 9th U.S. Circuit Court of Appeals in California ruled unanimously in December that people who donate bone marrow through a newer and less invasive technology can be paid for doing so, overturning a provision in the decades-old National Organ Transplant Act, which makes it a felony to pay donors for bone marrow and organs.

The Obama administration said the court was wrong to reach that conclusion and that paying for bone marrow could lead to an organ transplant market that favors the wealthy and exploits the sick and the poor.

In a petition filed Tuesday, U.S. Attorney General Eric Holder requested that a full 11-judge panel rehear the case. “The panel's ruling rests on legal errors of exceptional importance, threatens to disrupt current patient care, and undermines Congress's clear policy of encouraging voluntary bone marrow donations,” Holder wrote. “We respectfully urge that the case should be reheard.”

Bone marrow “transplants” are actually transfers of hematopoietic stem cells found in bone marrow and in blood. The older, painful method of bone marrow extraction involved removing marrow directly from the bone, via a large needle. But a newer method of extraction removes bone marrow stem cells from a donor's bloodstream in a process similar to donating blood, except that patients must take medication to spur greater production of hematopoietic stem cells, the donation process takes several hours, and instead of collecting bags of blood, the hematopoietic stem cells from the donor's bloodstream are filtered out and collected. The newer method is now used in at least two-thirds of marrow donations, according to the court's December decision.

The appeals judges argued that when Congress passed the National Organ Transplant Act, it wasn't taking into account the new method. But Holder wrote that the three judges were wrong in that interpretation and that the organ transplant law specifically classifies “bone marrow” as “the cells found in adult bone marrow and peripheral blood,” so the law was meant to ban payments for peripheral blood stem cell donations.

One of the parties to the lawsuit is a California nonprofit that would like to offer incentives to bone marrow donors. The group, MoreMarrowDonors.org, proposes offering $3,000 in awards in the form of scholarships, housing allowances, or gifts to charities, at first to minority and mixed-race bone marrow cell donors.

Proponents of paying donors argue that there aren't enough matches in the voluntary National Bone Marrow Program registry, and providing incentives would allow more life-saving matches to be made.

There are also five individual plaintiffs in the case, including parents of children with diseases such as leukemia that can be deadly without bone marrow transplants, and a bone marrow transplant expert physician who said at least one in five of his patients die because no matching bone marrow donor can be found. They argue that bone marrow donation is not so different from blood, plasma, sperm, or egg donation, which are not protected under the National Organ Transplant Act.

Opponents argue that providing payments for bone marrow could make transplants more widely available to the rich than to people with less money, that poor people could be exploited to sell marrow, or that payments might spur an uptick in the existing market of organ thefts.

If the 9th Circuit Court of Appeals declines to rehear the case, the Obama administration can petition the Supreme Court. Visit MedPageToday for the article.

 

Chefs, butlers, marble baths: Hospitals vie for the affluent

The feverish patient had spent hours in a crowded emergency room. When she opened her eyes in her Manhattan hospital room last winter, she recalled later, she wondered if she could be hallucinating: “This is like the Four Seasons — where am I?” The bed linens were by Frette, Italian purveyors of high-thread-count sheets to popes and princes. The bathroom gleamed with polished marble. Huge windows displayed panoramic East River views. And in the hush of her $2,400 suite, a man in a black vest and tie proffered an elaborate menu and told her, “I’ll be your butler.”

It was Greenberg 14 South, the elite wing on the new penthouse floor of NewYork-Presbyterian/Weill Cornell hospital. Pampering and décor to rival a grand hotel, if not a Downton Abbey, have long been the hallmark of such “amenities units,” often hidden behind closed doors at New York’s premier hospitals. But the phenomenon is escalating here and around the country, healthcare design specialists say, part of an international competition for wealthy patients willing to pay extra, even as the federal government cuts back hospital reimbursement in pursuit of a more universal and affordable American medical system.

“It’s not just competing on medical grounds and specialties, but competing for customers who can go just about anywhere,” said Helen K. Cohen, a specialist in health facilities at the international architectural firm HOK, which recently designed luxury hospital floors in Singapore and London and renovated NewYork-Presbyterian’s elite offerings in the McKeen Pavilion in Washington Heights. “These kinds of patients, they’re paying cash — they’re the best kind of patient to have,” she added. “Theoretically, it trickles down.”

A waterfall, a grand piano and the image of a giant orchid grace the soaring ninth floor atrium of McKeen, leading to refurbished rooms that, like those in the hospital’s East 68th Street penthouse, cost patients $1,000 to $1,500 a day, and can be combined. That fee is on top of whatever base rate insurance pays to the hospital, or the roughly $4,500 a day that foreigners are charged, according to the hospital’s international services department.

Many American hospitals offer a V.I.P. amenities floor with a dedicated chef and lavish services, from Johns Hopkins Hospital in Baltimore to Cedars-Sinai Medical Center in Los Angeles, which promises “the ultimate in pampering” in its $3,784 maternity suites. The rise of medical tourism to glittering hospitals in places like Singapore and Thailand has turned coddling and elegance into marketing necessities, designers say.

The spotlight on luxury accommodations comes at an awkward time for many urban hospitals, now lobbying against cuts in Washington and highlighting their role as nonprofit teaching institutions that serve the poor. Indeed, NewYork-Presbyterian, which once opposed amenities units, would not answer questions about its shift, and declined a reporter’s request for a tour.

In Greenberg, where the visitors’ lounge seems to hang over the East River in a glass prow and Ciao Bella gelato is available on demand, the patient who likened her suite to the Four Seasons was not paying for it. She did not want to be identified because her wealthy boss, who picked up the bill, would not want publicity.

During a reporter’s unofficial visits to both units this month, however, some people enjoying the perks expressed uneasiness about those priced out. In space-starved New York, many regular hospital rooms are still double-occupancy, though singles are now the national standard for infection control and quicker recovery.

At Mount Sinai Medical Center, where the aesthetic of the Eleven West wing is antique mahogany rather than contemporary sleek, and the best room costs $1,600, William Duffy, the hospital’s director of hospitality, said his favorite entree was Colorado rack of lamb, adding, “We pride ourselves on getting anything the patient wants. If they have a craving for lobster tails and we don’t have them on the menu, we’ll go out and get them.”

The 19-room unit, which opened 18 years ago but received a recent face-lift, takes in $3.5 million a year, Duffy said, estimating that 30 percent of its clientele comes from abroad. If the emergency room is backed up, a regular patient may be upgraded, he added: “Bump ’em up to Business, as we say.”

Wayne Keathley, Mount Sinai’s president, said the lack of interns and residents on Eleven West was a function of clinical judgments and limits to the training program, not the preferences of rich patients. But even the rainmakers — doctors who bring in such patients — can sometimes resent the tilt toward luxury.

Increasingly, hospitals serving the merely well-off are joining the amenities race. Beth Israel Medical Center near Union Square added a “deluxe unit” in 2008, catering mainly to patients after elective orthopedic surgery. The green-carpeted lobby may be more Radisson than Ritz, but its 12 single rooms starting at $450 feature Bose stereos and flat-screen TVs, and chef-prepared kosher food is served on china.

“A very insignificant portion of our beds are identified as deluxe accommodations,” said Gail Donovan, the chief operating officer of Continuum Partners, which includes Beth Israel and St. Luke’s-Roosevelt Hospital. “Our mission is really to be the safety net hospitals of our communities.” Visit the New York Times for the article.

 

House Democrats seek hearing on risks from J&J Mesh, Allergan Lap-Band

House Democrats called for congressional hearings on a gastric band made by Allergan Inc. and transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients.

U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers. The inquiry is critical as Congress considers an overhaul of Food and Drug Administration rules for medical devices, the Democratic lawmakers said in a statement.

The FDA ordered New Brunswick, New Jersey-based J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants earlier this month, citing reports of internal injuries. The Democrats said studies also showed high rates of complications with the Lap-Band made by Allergan.

“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Democrats said in a letter to the Republicans. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”

The Democrats cited a study, published last week in the medical journal Archives of Surgery, that found almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications, the letter said. The study used an older band and an older surgical technique, said Naziah Lasi-Tejani, a spokeswoman for Irvine, California-based Allergan, in a telephone interview. Using a newer version and updated techniques, the rate of patients needing a follow-up operation is three times lower, she said. Complication rates in the study were also “significantly higher” than what Allergan has seen in clinical practice, suggesting doctor training is key, Lasi-Tejani said.

Congress has until October to reauthorize a law that funds the FDA’s review of new products. House Republicans’ hearings so far threaten to give a “skewed” portrait of the situation, the Democrats said in today’s letter. They said Republicans still haven’t responded to an October request to hold a hearing on artificial hips and implanted brain stents that have also raised safety concerns.

The Energy and Commerce Committee is “thoroughly examining” device rules and plans another hearing on Feb. 15, said Debbee Keller, a spokeswoman for the committee’s Republican majority. She didn’t give specifics on the hearing’s agenda. Visit Bloomberg for the article.

 

Man dies of bird flu in southwest China: Xinhua

A man in southwest China died of bird flu on Sunday after three days of intensive care treatment in hospital, the official Xinhua news agency quoted the Ministry of Health as saying. The 39-year old – who died in hospital in Guiyan, capital of Guizhou province – began suffering from fever on January 6. Xinhua said China’s centers for disease control and prevention at provincial and national levels confirmed the man had died after being infected with the H5N1 bird flu strain.

The man had had close contact with 71 individuals, but none had shown unusual symptoms, the health ministry told Xinhua. The report did not mention whether the man had been in recent contact with birds.

The virus has become active in various parts of the world, mainly in east Asia during the cooler months.

Authorities in China are worried about the spread of infectious diseases around this time when millions of Chinese travel in crowded buses and trains across the country to go home to celebrate the Lunar New Year.

The current strain of H5N1 is highly pathogenic, kills most species of birds and up to 60 percent of the people it infects. The latest death follows that of a 39-year-old bus driver from Shenzhen in southern Guangdong province on December 31. (Reuters) Visit the Chicago Tribune for the article.

 

Anti-infective drug shortages pose threat to public health and patient care

Shortages of key drugs used to fight infections represent a public health emergency and can put patients at risk, according to a review published in Clinical Infectious Diseases and available online. Frequent anti-infective shortages can substantially alter clinical care and may lead to worse outcomes for patients, particularly as the development of new anti-infectives has slowed and the prevalence of multidrug-resistant pathogens is increasing.

Of the 193 medications unavailable in the U.S. at the time of the analysis, 13 percent were anti-infective drugs, the authors found, led by Marc Scheetz, PharmD, and Milena Griffith, PharmD, from Midwestern University Chicago College of Pharmacy and Northwestern Memorial Hospital in Chicago. “Anti-infectives often represent irreplaceable life-saving treatments,” the authors noted, and hospitalized patients are particularly vulnerable in an era when such shortages often last months and are occurring more frequently.

First-line treatments for herpes encephalitis, neurosyphilis, tuberculosis, and enterococcal infections, among others, have been hit by shortages, forcing physicians to use other drugs that may not work as well, the authors found. For example, the current shortage of the intravenous form of sulfamethoxazole/trimethoprim, a first-line treatment for Pneumocystis jiroveci pneumonia since the 1980s, may result in adverse outcomes for patients with severe disease.

Although the root cause of drug shortages can be hard to determine—current U.S. law does not require manufacturers to disclose such details—the authors point to several supply-side issues that play a role: procuring raw materials, processing, distributing, regulatory compliance, market shortages due to epidemics, new therapeutic indications, and perceived shortages.

Multidisciplinary stewardship programs that support the appropriate “selection, dosing, route of administration, and duration of antimicrobial therapy” can help front-line clinicians when a first-line anti-infective drug is in short supply, Scheetz said. Hospitals should also develop strategies that anticipate the impact and extent of drug shortages, as well as identify therapeutic alternatives that mitigate potential adverse outcomes.

Enhancing oversight by the Food and Drug Administration through congressional legislation may also be needed to identify and correct shortages of life-saving anti-infective drugs, conclude the authors, who describe recently introduced legislation on this topic. “Let your members of Congress know that addressing this issue is important for the proper care of patients,” Scheetz said. Visit IDSA for the article.



Healthcare services for all suffering from impact of Medicaid cuts

It has only been about three months since state officials instituted cuts to the state’s Medicaid coverage but already the impact is being felt by healthcare providers and consumers. The cuts rolled back an expansion of the Arizona Health Care Cost Containment System (AHCCCS) that was approved by voters in 2000, which extended coverage to childless adults earning up to 100 percent of the federal poverty level, or $10,890 annually. Prior to that, coverage was only available to those earning 34 percent of the federal poverty level.

The cuts, which are expected to save the state up to $500 million started with an enrollment freeze in July among the expanded population, which eliminated coverage for more than 100,000 people. According to AHCCCS officials, most of those were people who had lost their jobs, or who couldn’t afford health insurance until they became so sick they had no other options.

For Tucson organizations and healthcare facilities, sick individuals with no other options are now knocking on the doors of other Tucson healthcare providers desperately seeking help. Although providers say they are providing care on a case-by-case basis, the additional numbers are about to become overwhelming.

“We have had over 45 people since September that have had their coverage cut mid-treatment. These are not just breast cancer patients, but all types of cancers,” said Jaimie Leopold, executive director of Susan G. Komen for Southern Arizona. “There was a large influx in September after the benefits were cut of people who were in the middle of treatment. Now, we are getting about two to three per week of newly diagnosed patients that have been cut from the program.”

Leopold says the Komen organization is working closely with other providers, including Arizona Oncology, the University of Arizona Cancer Center, Tucson Medical Center and St. Elizabeth’s Health Center to do what they can to guide, support, and treat these patients.

St. Elizabeth’s alone is receiving up to four calls per week from patients seeking treatment. According to Iris Vazquez, patient services director for St. Elizabeth’s, it has been a difficult few months. She said her organization is diagnosing people who have never before been sick. Some are homeless, some have no income, some live with someone else and, in some cases, the cost of medication can be too much.

Two lawsuits have been filed seeking to reinstate the cuts but the courts have not ruled favorably. An Arizona Court of Appeals panel on Dec. 6 upheld the state’s right to implement the enrollment freeze and confirmed the authority to repeal the expansion despite the fact that it was approved by voters, as Proposition 204 in 2000. Visit Inside Tucson Business for the article.  

 


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