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Saturday, December 31, 2011

EMA To Review Aliskiren-Containing Medicines.

Reuters Share to FacebookShare to Twitter (12/23, Sandle, De Sa'pinto) reports the European Medicines Agency announced Thursday that it is reviewing medicines containing aliskiren due to the ALTITUDE study, which showed that Novartis' Rasilez [aliskiren] did not appear to benefit patients. In addition, patients on aliskiren had more adverse effects including renal complications, hyperkalemia, hypotension, and stroke. Also covering the story is Dow Jones Newswire Share to FacebookShare to Twitter (12/23, Baba, Subscription Publication).

Some Dems Ask Sebelius To Reject Lowering Of Medical Loss Ratio.

The Dallas Morning News Share to FacebookShare to Twitter (12/23) reports, "On Thursday, eight Democratic US House members from Texas jumped into a fray over state insurance regulators' request for delay of a federal rule that sets medical-spending minimums for health insurers. They announced they'd written US Health and Human Services Secretary Kathleen Sebelius, asking her to reject Texas' bid to allow insurers to devote 71 percent of individuals' premiums to medical care and quality improvements this year, 74 percent next year and 77 percent in 2013," instead of the 80% that healthcare reform currently requires. The Morning News lists the House members who signed the letter.

CDC Recommends Hep B Vaccine For Adults With Diabetes.

HealthDay Share to FacebookShare to Twitter (12/23, Preidt) reports, "Hepatitis B vaccination is recommended for all unvaccinated adults with type 1 and type 2 diabetes aged 19 to 59," according to new guidelines Share to FacebookShare to Twitter issued by the US Advisory Committee on Immunization Practices (ACIP) and published in the Dec. 23 issue of the Morbidity and Mortality Weekly Report, a publication of the US Centers for Disease Control and Prevention. The guidelines advise that "vaccination should be done as soon as possible after adults in this age group are diagnosed with diabetes."
        "Citing more limited data for older diabetics, committee members left the decision about whether to vaccinate diabetic adults 60 and older to the treating clinician," MedPage Today Share to FacebookShare to Twitter (12/23, Neale) reports. "The decision should be based on the risk of becoming infected with HBV -- including a consideration of the need for assisted blood glucose monitoring in long-term-care facilities -- and the likelihood of an adequate immune response to vaccination, which decreases with age." The recommendations say, however, that "no vaccination is necessary in patients who have been fully immunized at any point in the past."

Senators Seeking Thorough Review Of Graduate Medical Education System.

CQ Share to FacebookShare to Twitter (12/23, Norman, Subscription Publication) reports that in a bipartisan effort, seven senators "are asking the Institute of Medicine to do a thorough review of the nation's system of graduate medical education (GME) that funds medical residencies." In a Dec. 22 letter "to the IOM, the senators said they would like to see an independent review of the governance and financing of the GME system, including inequities in funding across states based on their needs and capacity." The letter stated, "We believe our GME system is under increasing stress and the projections for our health care workforce are of significant concern." It added, "There is growing concern that the United States is failing to adequately match medical training with our medical needs on a national level." The authors of the letter were Jeff Bingaman (D-NM), Tom Udall (D-NM), Mark Udall (D-CO), Michael Bennet (D-CO), Jon Kyl (R-AZ), Charles Grassley (R-IA), and Michael D. Crapo (R-ID).

Translating knowledge on best practice into improving quality of RRT care: a systematic review of implementation strategies.

PMID: 21775971

van der Veer SN, Jager KJ, Nache AM, et al.
Kidney Int. 2011 Nov;80(10):1021-34. doi: 10.1038/ki.2011.222. Epub 2011 Jul 20. (Review)

Abstract Recent studies showed wide variation in the extent to which guidelines and other types of best practice have been implemented as part of routine health care. This is also true for the delivery of renal replacement therapy (RRT) for ESRD patients. Increasing uptake of best practice within such complex care systems requires an understanding of implementation strategies and specific quality improvement (QI) techniques. Therefore, we systematically reviewed over 5000 titles published since 1990 and included papers describing planned attempts to accelerate uptake of best RRT practice into daily care. This resulted in a list of 93 QI initiatives, categorized in order to expedite shared learning. The majority of the initiatives were executed within the domains of vascular access, nutrition, and anemia management. Strategies oriented at patients were most common and many initiatives pre-defined an improvement target before starting implementation. Of the 93 initiatives, 22 were sufficiently robust methodologically to be analyzed in more detail. Our results tend to support previous findings that multifaceted strategies are more effective than single strategies. Improving our understanding of how to successfully implement best practice can inform system-level change and is the only way to close the gap between knowledge on what works and the actual care delivered to ESRD patients. Research into implementation, using specific QI techniques, should therefore be given priority in future.

FDA Approves Generic BP Medication Eprosartan.

The AP Share to FacebookShare to Twitter (12/28) reports, "Mylan Inc. said Tuesday that the Food and Drug Administration approved the drugmaker's generic version of the high blood pressure treatment eprosartan [Teveten]." The company stated that "it is now shipping generic Teveten in strengths of 400 milligrams and 600 milligrams" and "it will have six months of marketing exclusivity."

CMS To Reduce Medicare Payments For 30% Of ESRD Centers.

In continuing coverage, American Medical News Share to FacebookShare to Twitter (12/27) reported in its "News in Brief" section that "Medicare payments to about 1,500 end-stage renal disease facilities will be reduced by up to 2% in 2012, the Centers for Medicare & Medicaid Services announced Dec. 15." CMS explained that "the pay rate adjustments are the result of a value-based purchasing program involving nearly 5,000 facilities during the 2010 reporting year, during which the government measured facilities' anemia management and dialysis adequacy. Nearly 70% of those facilities achieved high scores on the quality measures and will not be penalized in 2012, CMS said." The item quoted CMS Administrator Marilyn Tavenner, who stated, "The real purpose of value-based purchasing is to raise the bar on quality, and that's exactly what CMS is aiming to do for Medicare patients who have" end-stage renal disease (ESRD).

Most Patients Rate Their Own Physicians Very Highly.

American Medical News Share to FacebookShare to Twitter (12/27, O'Reilly) reported, "Even as physicians face increasing pressure to perform well on measures of patient satisfaction, they may take some comfort in knowing that most patients rate their own doctors very highly." Research "based on nearly 15,000 patient online ratings between 2004 to 2010" indicated that "the average physician rating is 9.3 out of 10." American Medical News added, "The less time that patients spend in the waiting room and the more time they spend in the exam room with a physician, the higher the doctor's rating, the study said." The research was published in Health Outcomes Research in Medicine.

Medical Group Report Features Malpractice Claims Costs.

Modern Healthcare Share to FacebookShare to Twitter (12/25, Robeznieks, Subscription Publication) reported, "A physician's average cost for defending a malpractice claim was more than $47,000 and the average payout was almost $332,000 in 2010, according to a report from the American Medical Association." In addition, "also stated that in 2010, 63.7% of all closed claims were either dropped, withdrawn or dismissed-but still cost almost $27,000 to defend and accounted for more than one-third of total defense expenses for the year." The AMA "report highlights how rates continue to climb and how obstetricians/gynecologists and surgeons in New York are now paying premiums of almost $207,000 and $129,000 respectively."

Smoking During Pregnancy May Lead To Arterial Damage In Offspring.

MedPage Today Share to FacebookShare to Twitter (12/27, Walsh) reported, "Maternal smoking during pregnancy can lead to arterial damage detectable in the offspring at five years, yet three-quarters of parents of young children continued to smoke after participating in smoking cessation programs," according to a study Share to FacebookShare to Twitter published in the January issue of Pediatrics. The researchers "analyzed data from a prospective population-based study that included 259 children" and found that "children whose mothers smoked while pregnant had carotid artery intima-media thickness 18.8 ┬Ám thicker (95% CI 1.1 to 36.5, P=0.04) than those with no prenatal smoke exposure" and "also had arterial distensibility that was 15% (95% CI −0.3 to −0.02, P=0.02) lower." An accompanying editorial Share to FacebookShare to Twitter observed that "more work needs to be done to elucidate the relationship between fetal exposure and later life complications." WebMD Share to FacebookShare to Twitter (12/26, Rubin) also reported this story.

Few Trials Examine Effects Of A Drug In Patients With Multiple Chronic Conditions.

This is advice that all physicians (young and old) need to remember in this age of "Evidence Based Medicine".

MedPage Today Share to FacebookShare to Twitter (12/28, Walker) reports, "Few major randomized, controlled clinical trials examine the effects of a drug in patients who have multiple chronic conditions, even though more than one-quarter of all Americans are living with at least two chronic health conditions," according to "a research letter Share to FacebookShare to Twitter published in the Dec. 28 issue of the Journal of the American Medical Association." Meanwhile, "the proportion is even greater for older individuals, two out of three of whom are likely to have at least two chronic health conditions, according to Alejandro Jadad, MD, and colleagues from the Centre for Health, Wellness and Cancer Survivorship at the University Health Network in Toronto." This "means that most trials on which the FDA bases its approval of new drugs are not generalizable to the US population." 


Sodium-Potassium Ratio May Be More Important Than Total Sodium Intake.

The New York Times Share to FacebookShare to Twitter (12/26, D7, Brody, Subscription Publication) reported in "Personal Health" that research published in the Archives of Internal Medicine "found that while a diet high in sodium -- salt is the main source -- increases your risk" of heart disease, "even more important is the ratio of sodium (harmful) to potassium (protective) in one's diet." One of the study's authors, Dr. Elena V. Kuklina, a nutritional epidemiologist at the Centers for Disease Control and Prevention, said, "We controlled for all the major cardiovascular risk factors and still found an association between the sodium-potassium ratio and deaths from heart disease." The Times points out that, "according to an Institute of Medicine report on sodium released last year, 'No one is immune to the adverse health effects of excessive sodium intake.'"

Copyright and Open Access at the Bedside

This is an interesting "PERSPECTIVE" article

NEJM Article


John C. Newman, M.D., Ph.D., and Robin Feldman, J.D.
N Engl J Med 2011; 365:2447-2449December 29, 2011
Article
References
For three decades after its publication, in 1975, the Mini–Mental State Examination (MMSE) was widely distributed in textbooks, pocket guides, and Web sites and memorized by countless residents and medical students. The simplicity and ubiquity of this 30-item screening test — covering such functions as arithmetic, memory, language comprehension, visuospatial skills, and orientation — made it the de facto standard for cognitive screening. Yet all that time, it was under copyright protection. In 2000, its authors, Marshal Folstein, Susan Folstein, and Paul McHugh, began taking steps to enforce their rights, first transferring the copyright to MiniMental, a corporation the Folsteins founded, and then in 2001 granting a worldwide exclusive license to Psychological Assessment Resources (PAR) to publish, distribute, and manage all intellectual property rights.1,2 A licensed version of the MMSE can now be purchased from PAR for $1.23 per test. The MMSE form is gradually disappearing from textbooks, Web sites, and clinical tool kits.1
Clinicians' response to this “lockdown” has been muted. A few commentators have expressed concern about continuing to use a now-proprietary tool in training2 or about implications for the developing world,1 echoing debates about patented pharmaceuticals. In our experience, many clinicians are either unaware of the MMSE's copyright restrictions or simply ignore them, despite the risk of copyright infringement.
But then in March 2011, a promising new cognitive screening tool that was to be available through “open access,” the Sweet 16 — a 16-item assessment of thinking, learning, and memory developed by Harvard's Tamara Fong3 — was removed from the Internet at the request of PAR in an apparent copyright dispute.4 The Sweet 16 includes orientation and three-object recall items, similar to the MMSE's, along with a digit-span item. This action, unprecedented for a bedside clinical assessment tool, has sent a chill through the academic community; clearly, clinicians and researchers can no longer live in blissful ignorance of copyright.
Copyright derives from one of the few powers explicitly mentioned in the U.S. Constitution. Any new intellectual work is under copyright protection automatically from the moment it is fixed in a tangible medium of expression — a category now including blog posts, iPhone apps, and cognitive screening tools. Copyright law grants the author (or owner, for copyright can be transferred) exclusive rights to copy the work, distribute it, make works derivative of it, and perform or display it publicly. These rights last for 70 years past the date of the author's death, or up to 120 years from the time of creation if the work was done “for hire.” This duration has been retroactively extended several times, so that works published as early as 1923 may remain under copyright today (and will until at least 2019).
For persons or entities other than the copyright holder to copy or distribute a work, they must have permission from the owner, usually in the form of a license. Copying or distribution without permission is copyright infringement and carries stiff civil or even criminal penalties. There is limited protection under “fair use” law for certain nonprofit uses of limited parts of a work — for example, for teaching or research — but that exception is narrower than it sounds. One need not have intended to infringe someone's copyright to be subject to damages of up to $30,000 per work, and willful infringers pay up to $150,000 — and may, under certain circumstances, be subject to a jail term.
For clinicians, the risk of infringement is real. Photocopying or downloading the MMSE probably constitutes infringement; those who publish the MMSE on a Web site or pocket card could incur more severe penalties for distribution. Even more chilling is the “takedown” of the Sweet 16, apparently under threat of legal action from PAR (although PAR has not commented publicly). Are the creators of any new cognitive test that includes orientation questions or requires a patient to recall three items subject to action by PAR? However disputable the legal niceties, few physicians or institutions would want to have to argue their case in court.
The MMSE case may be a harbinger of more to come. Many clinical tools we take for granted, such as the Katz Index of Independence in Activities of Daily Living, fall into the same “benign neglect” copyright category as the MMSE did before 2000. At any time, they might be pulled back behind a wall of active copyright enforcement by the authors or their heirs.
What can researchers do to ensure that our colleagues can use the tools we develop to improve patient care? One option is to essentially place works in the public domain by declaring free and open rights for all users. The Geriatric Depression Scale, the Patient Health Questionnaire (PHQ-9) depression scale, and the Saint Louis University Mental Status (SLUMS) cognitive assessment tool are all in the public domain. That domain, however offers no mechanism for ensuring that authors are recognized or compensated and no means of guaranteeing that later improvements will be made freely available. The ability to improve a clinical tool is crucial. Even licenses granting wide permission to copy, such as those of the Montreal Cognitive Assessment and the Lawton Instrumental Activities of Daily Living (IADL) scale, while laudable, might still inhibit innovation by permitting legal challenges to improved tools perceived as derivative (as may have been the case with Sweet 16 and the MMSE).
A better solution is to apply the principle of “copyleft” from the open-source technology movement to encourage innovation and access while protecting authors' rights. Copyleft is intellectual jujitsu that uses copyright protection to guarantee the right of anyone to use, modify, copy, and distribute a work, as long as it and any derivatives remain under the same license. The author retains the right to offer the work under a different license simultaneously — for example, giving a company specific license to commercialize the work without copyleft protections. Popular copyleft licenses include the Creative Commons Attribution-ShareAlike license and the GNU Free Documentation License.
Google, Apple, Facebook, and Twitter all use open-source software at the heart of their products, because there is a clear economic benefit to using well-tested, well-validated, continually improved software in the core of complex products. Similarly, there is a clear clinical benefit to using well-tested, well-validated, continually improved clinical tools in complex patient care — as demonstrated by the MMSE's use before 2000. In a sense, copyleft is how academic medicine has always been assumed to work.2 Restrictive licensing of such basic tools wastes resources, prevents standardization, and detracts from efforts to improve patient care.
We suggest that authors of widely used clinical tools provide explicit permissive licensing, ideally with a form of copyleft. Any new tool developed with public funds should be required to use a copyleft or similar license to guarantee the freedom to distribute and improve it, similar to the requirement for open-access publication of research funded by the National Institutes of Health.5 The solution can be as simple as placing a copy of the tool on the authors' Web site, with a statement naming or linking to the license. Clinicians and researchers would be free to use, copy, and improve the tool; improvements would have to offer a similar copyleft license, perpetuating the benefits. Yet authors would maintain ownership and copyright of their tool and could profit by licensing it for a fee to commercial users or publishers who wished to include it in a non-copyleft work.
The restrictions on the MMSE's use present clinicians with difficult choices: increase practice costs and complexity, risk copyright infringement, or sacrifice 30 years of practical experience and validation to adopt new cognitive assessment tools. By embracing the principles of copyleft licensing, we can avoid such setbacks and build a more open future of continually improving patient care.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Source Information

From the Division of Geriatrics, San Francisco Veterans Affairs Medical Center, and the University of California San Francisco (J.C.N.); and the Law and Bioscience Project, University of California Hastings College of the Law (R.F.) — all in San Francisco.

Researchers Find Bacteria Lurking In Unused Paper Towels.

WebMD Share to FacebookShare to Twitter (12/29, Goodman) reports, "Grabbing a paper towel in a public restroom may leave more on your hands than you bargained for," according to a study published in the American Journal of Infection Control. Investigators "say they've found bacteria, including some that are known to make people sick, in unused paper towels." According to WebMD, "Experts say the findings are probably most important for people in hospital isolation units and those with weakened immune function who need to be extra cautious about contact with germs."

Enoxaparin Plus Compression Stockings May Not Reduce Mortality In Severely Ill Patients.

HealthDay Share to FacebookShare to Twitter (12/29, Mann) reports, "Severely ill hospital patients are at high risk for developing potentially fatal blood clots, and often wear compression stockings and/or take blood thinners to help lower this risk. However, adding the blood thinner Lovenox (enoxaparin) to the mix does not reduce their chances of dying from a blood clot, according to research Share to FacebookShare to Twitter appearing in the Dec. 29 issue of the New England Journal of Medicine." For patients who "were given Lovenox, the risk of death from any cause was 4.9 percent," while "this risk was 4.8 percent among those participants who were given a placebo."
        According to MedPage Today Share to FacebookShare to Twitter (12/29, Walsh), researchers "noted that, while thromboprophylaxis in surgical patients has been shown to decrease the rate of lethal pulmonary embolism, acutely ill medical patients may be at risk for death from many causes other than pulmonary embolism, 'thus diminishing the ability of pharmacologic prophylaxis to improve the overall clinical outcome.'" In addition, the study took place in "193 centers, most of which were in India or China," and "rates of pulmonary embolism have been reported to be lower in Asia than in Western countries." Other explanations include "that the use of compression stockings alone was sufficient to prevent the development of the venous clots that can ultimately lead to pulmonary embolism" or "that their study population may have been at a lower risk for thromboembolism than in other studies, by being younger and less likely to be obese, as well as in having low rates of previous thromboembolic events."

Red, Grilled, Barbequed Meat May Be Linked To Kidney Cancer.

Reuters Share to FacebookShare to Twitter (12/29, Pittman) reports a study Share to FacebookShare to Twitter in the American Journal of Clinical Nutrition suggesting that people who eat high amounts of red, grilled, or barbequed meat may be at higher risk of kidney cancer. In a study of 500,000 US adults, it was found that eating the most red meat was linked with papillary cancers, but not clear-cell kidney cancers. Participants who ate high amounts of well-done grilled and barbecued meat likewise had an increased risk of kidney cancer. Researchers said the reason for the association is unclear and emphasized that the data do not prove causation.

Laboratory generated blood successfully injected into human subject.

The Chicago Tribune (12/29) reports that according to a study in published in the journal Blood, "red blood cells generated in a lab have been successfully injected into a human volunteer for the first time." French researchers extracted "hematopoetic stem cells from a volunteer's bone marrow" and used various growth factors to induce the cells to differentiate into red blood cells (RBC). "After five days, 94 to 100 percent of the cells remained in circulation, while after 26 days, 41 to 63 percent remained -- a survival rate comparable to normal red blood cells. The cultured blood cells also gave every indication of being safe to use. ... They behaved like normal red blood cells, binding to oxygen and releasing it." While this result is promising, researchers note that "next challenge is to scale up production to a point where the cultured blood cells can be made quickly and cheaply in sufficient quantities for blood transfusions."

Australia warns of oseltamivir-resistant H1N1.

The Los Angeles Times (12/29, Kaplan) "Booster Shots" blog reports that in Australia, which has "wrapped up its flu season months ago," public health officials are concerned by the finding that "in and around the Australian city of Newcastle, the Tamiflu [oseltamivir]-resistant H1N1 virus was spreading more easily among humans, according to a report being published in Thursday's edition of the New England Journal of Medicine." In a sample of 182 patients, 29 (16%) were resistant. "Genetic analysis of the flu samples revealed that all of the 29 patients were infected with a single strain," but experts are unsure how the strain was spread, since many patients "had no known epidemiologic link." Researchers "warned flu experts in the Northern Hemisphere to be on the lookout for this flu strain – or any other strain that is resistant to Tamiflu – this winter."
        HealthDay (12/29, Mozes) reports that the resistant virus was also resistant to "an older class of adamantine treatments (rimantadine and amantadine)." However, "the resistant strains remained 'fully sensitive' to treatment with another drug, Relenza (zanamivir)." Researcher Aeron C. Hurt, of the World Health Organization, noted that in 2007/2008, when "the pandemic 2009 A(H1N1) flu strain" developed resistance, "within 12 months the virus had spread globally, such that virtually every A(H1N1) virus around the world was resistant to [Tamiflu]." He expressed concern that a similar situation will occur with this strain.

Lidless toilets contaminate surrounding areas with clostridium difficile.

Medscape (12/30, Laidman) reports, "Put a lid on it. That is the conclusion of research examining the amount of Clostridium difficile that flies into the air and contaminates surrounding surfaces with the flush of a lidless toilet." The study, published in online Dec. 2 in the International Journal of Hospital Infection, "measured airborne suspension of the bacteria in addition to surface contamination by the bacteria after flushing of both lidless and lidded toilets" and found that "air samples 25 cm above the commode, which is about the height of the handle, contained C difficile, with the highest numbers coming from samples taken immediately after flushing." In addition, the "researchers also found the number of viable bacteria to be 12-fold higher from open toilets compared with the same toilet when the lid was closed."

Silent Strokes May Be Linked To Memory Loss In Older Patients Without Dementia.

ABC World News (12/29, story 7, 1:45, Muir) reported that "silent strokes" may "explain that increasing memory loss over the years," according to a new study Share to FacebookShare to Twitter .
        On its website, ABC News Share to FacebookShare to Twitter (12/30) reports that investigators "looked at 658 participants with an average age of 79 who had no history of dementia." Participants "were administered a test that gauged their memory, language skills and thinking abilities." The "researchers also measured the size of the participants' hippocampus, crucial to the regulation of memory and emotion, and they also administered an MRI brain scan."
        HealthDay Share to FacebookShare to Twitter (12/30, Mozes) reports, "The brain scans revealed that 174 of the participants had experienced silent strokes, and the investigators found that these seniors did not perform as well on the memory exams." The "finding held regardless of whether the part of the patient's brain responsible for memory (the hippocampus) was found to be relatively small or not." The research was published online in the journal Neurology.
        MedPage Today Share to FacebookShare to Twitter (12/30, Phend) reports, "Just 66 of the participants reported having had a clinical stroke, suggesting that 'brain infarction is largely a silent injury.'" WebMD Share to FacebookShare to Twitter (12/30, Doheny) also covers the story.