JAMA

doi: 10.1001/jama.2010.1642pmid: N/A

Automated Surveillance of Cardiovascular Devices In an analysis of cardiovascular device registry data from Massachusetts patients who underwent percutaneous coronary intervention and device implantation between April 2003 and October 2007, Resnic and colleagues Article found that computer-automated surveillance of the device registry was feasible and identified early, low-frequency potential safety risks that had not been observed in premarket approval studies of the devices. In an editorial, Rumsfeld and Peterson Article discuss the need for a proactive postapproval medical device surveillance system. Primary Health Care and CHD Mortality England's national health system provides universal access to health care; however, there remain geographic variations in coronary heart disease (CHD) mortality. In a cross-sectional study that involved all 152 geographically determined primary care trusts in England, Levene and colleagues examined population characteristics (eg, socioeconomic deprivation, levels of smoking, race/ethnicity, and registers of persons with diabetes—a measure of diabetes prevalence) and health service characteristics (eg, level of provision of primary care services and clinical performance data) and found that wide variations in CHD mortality were predominantly explained by population characteristics. Reporting of Nosocomial Bloodstream Infection Central line–associated bloodstream infection rates are a patient care measure included in publicly released hospital report cards. However, if infection surveillance is not performed consistently across hospitals, hospital comparisons based on this measure would lack validity. To assess institutional variation in the performance of traditional bloodstream infection surveillance, Lin and colleagues compared central line–associated bloodstream infection rates derived from routine surveillance with infection rates determined through retrospective application of a computer algorithm reference standard. The retrospective cohort study involved 20 hospital intensive care units located at 4 medical centers and the authors found significant variation across medical centers in the application of standard central line–associated bloodstream infection surveillance definitions. Adolescent Obesity and Risk of Obesity in Adulthood The and colleagues assessed the incidence and risk of severe obesity in adulthood in relation to adolescent weight status in an analysis of data from 8834 participants aged 12 to 21 years who enrolled in 1996 in the National Longitudinal Study of Adolescent Health and had follow-up into adulthood (through 2007-2009). The authors report that obesity in adolescence was significantly associated with increased risk of incident severe obesity in adulthood, with variations in risk by sex and race/ethnicity. CLINICIAN'S CORNER Does This Patient Have Malaria? The Rational Clinical Examination Clinical features of malaria infection are notoriously nonspecific and missed diagnoses are common. In a systematic literature review, Taylor and colleagues examined the predictive value of clinical findings associated with endemic and “imported” (travel-acquired) malaria in adults and children. The authors found that in endemic areas individual clinical features of malaria have limited predictive utility. Among returning travelers, information from the travel history and the presence of fever, splenomegaly, hyperbilirubinemia, or thrombocytopenia are associated with an increased likelihood of malaria; however, prompt laboratory testing is recommended. A Piece of My Mind “We share very little of our lives with patients—indeed even with colleagues—and our walls are one (if not the only) way of sharing.” From “Suitable for Framing.” Medical News & Perspectives Efforts are under way to improve tools for assessing cardiovascular disease risk. Commentaries 21st-century cardiovascular disease prevention Putting ad hoc PCI on pause Desktop medicine Intentional infection of vulnerable populations Author in the Room Teleconference Join Michael A. Steinman, MD, Wednesday, November 17, from 2 to 3 PM eastern time to discuss managing medications for elders with clinically complex medical conditions. To register, go to www.ihi.org/AuthorintheRoom. Audio Commentary Dr DeAngelis summarizes and comments on this week's issue. Go to http://jama.ama-assn.org/misc/audiocommentary.dtl. JAMA Patient Page For your patients: Information about malaria.

doi: 10.1001/jama.304.18.1987pmid: N/A

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DeAngelis, MD, MPH Executive Deputy Editor: Phil B. Fontanarosa, MD, MBA Deputy Editors: Richard M. Glass, MD, Drummond Rennie, MD Deputy Editor and Online Editor: Margaret A. Winker, MD Managing Deputy Editor: Annette Flanagin Senior Contributing Editor: M. Therese Southgate, MD Senior Editors: Robert M. Golub, MD, Ronna Henry, MD Associate Senior Editor: Roxanne K. Young Contributing Editors: Derek C. Angus, MD, MPH, Robert G. Badgett, MD, Huan J. Chang, MD, MPH, Helene M. Cole, MD, Thomas B. Cole, MD, MPH, David S. Cooper, MD, J. Michael Gaziano, MD, MPH, Edward H. Livingston, MD, David H. Mark, MD, MPH, Mary McGrae McDermott, MD, Robert A. McNutt, MD, Boris Pasche, MD, PhD, Eric D. Peterson, MD, MPH, Jeanette M. Smith, MD, Janet M. Torpy, MD, John L. Zeller, MD, PhD, Gianna Zuccotti, MD, MPH, Jody W. Zylke, MD Statistical Editor: Naomi Vaisrub, PhD Associate Editor: Charlene Breedlove Fishbein Fellow: Ryszard M. Pluta, MD, PhD Contributing Writers: Robert H. 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Cole, Thomas B.

doi: 10.1001/jama.2010.1626pmid: 21063001

The primary interest of Joseph Mallord William Turner (1775-1851) as a painter was the behavior and appearance of light in the atmosphere. He was aware—from reading scientific publications and corresponding with their authors—that different hues could be obtained by splitting white light into its component wavelengths. Conversely, primary colors could be combined to produce white light. With this principle in mind, Turner set himself the task of representing the extraordinary effects of atmospheric light on canvas and paper. It wasn't as simple as mixing colors to paint what he saw. When two pigments are mixed together, the resulting compound is often less brilliant than the separate pigments before mixing, because some of the light reflected by one of the mixed pigments is typically absorbed by the other. To preserve the intensity of component hues, Turner painted little patches of different colors close together, so that the combinations of colors would be perceived in the eye, unadulterated by the mixing of pigments on the palette. This visual effect, known as optical mixing, not only allows the perception of blended color without loss of intensity, but also creates a flickering or glimmering sensation as the eye and the brain work together to mix the perceptions of color. Clear blue skies with fleecy clouds held little interest for Turner, because the light on a clear day has a fairly uniform color and intensity. On the other hand, light that is bent, split, and magnified by physical forces is much more challenging to paint. Turner not only welcomed these artistic challenges, but sought them out. If he lacked the direct experience of a cataclysmic event, such as a battle at sea or the eruption of a volcano, he would work from the studies of other painters, but he much preferred to see the event for himself. Forces that change the configuration of sky and water, such as wind, heat, precipitation, and gravity, alter the direction and appearance of light in complex ways that appealed to Turner's eye. By 1834, Turner had lived almost 60 years and had been painting for at least 45 of them (JAMA cover August 9, 2000). He had a clear idea of the kind of landscape view he found most compelling. Turner was a native of London and a member of the faculty at the Royal Academy of Art, but he was also a seasoned traveler who made drawings of storms and other atmospheric events in different locales. Over the course of the night of October the 16th he would have the opportunity to sketch a firestorm in his own city. It began in the House of Lords on the west bank of the River Thames. During the afternoon, two maintenance workers were instructed to clear a storage room of wooden tally sticks and burn them. Tally sticks had been used for centuries to keep track of government receipts and payments, but they had long been obsolete and were taking up needed space. Following orders, the workers stuffed the scrap wood into the underground furnace. The stoked furnace overheated its flue, damaging the copper lining, which then heated the exposed brickwork and ignited the wooden joists supporting the stone floor. The fire spread to the wooden and fabric furnishings inside the chamber and engulfed the House of Lords and the adjacent House of Commons. Tens of thousands of spectators, including Turner, gathered along the banks of the river to watch. As the fire fed on the burning buildings, the heat and flames rose high into the night sky. The updraft pulled gusts of wind that fanned the flames, forming a mushroom cloud of soot and ash. Turner hired a boat and prowled along the banks of the river, filling a sketchbook with rough drawings. Subsequently he made two oil paintings of the fire as seen from different vantage points (JAMA cover October 16, 1981). In The Burning of the Houses of Lords and Commons, 16 October, 1834 (cover ), moonlight filters through the soot and vapor clouds that surround the vortex of the fire. A filmy fog envelops the burning buildings and a blackened smear darkens the upper reaches of the column of flame. The white-hot glare at the heart of the fire is so intense that it blurs the framework of the bridge. Higher up, beyond the fuel source, the flames have cooled to orange and red. To preserve the intensity of the colors, Turner painted them as tiny blotches in the air and stacks of parallel bars in the water's reflection. Yellow highlights at the edge of the column of fire give its gray soot corona a violet tinge. This type of “induced color” or afterimage was another facet of Turner's signature style. Joseph Mallord William Turner (1775-1851), The Burning of the Houses of Lords and Commons, 16 October, 1834, 1835, British. Oil on canvas. 92 × 123.2 cm. Courtesy of the Cleveland Museum of Art (http://www.clevelandart.org/), Cleveland, Ohio; bequest of John L. Severance, 1942.647. © The Cleveland Museum of Art. The burning of Parliament was the most destructive fire in London since the Great Fire of 1666. Firefighters and civilian volunteers managed to save only a few of the buildings. The structure was rebuilt in the Gothic revival style and is today one of the most familiar landmarks of London. As in Turner's day, boats carry passengers up and down the River Thames, and on a clear night thousands of colored lights are reflected in its smooth surface. However, on a clear night it is unlikely that Turner would take much of an interest in the view.

McMahon, Ted

doi: 10.1001/jama.2010.1538pmid: N/A

An ordinary Thursday afternoon, first patient late. He sits where one-year checkups always do, on his parent's lap, new-hatched wariness soon dispelled. All is well—two days from now I’m on vacation. And when, as in the usual course of things I feel his belly, I feel the mass that fills the whole right side. Because I have done this before, and because in that instant the ghosts of thirty years materialize, I know that in the next two minutes I’ll destroy this couple's world as now they know it. And the rest of the afternoon, as reports come in from lab and ultrasound, I’ll say to other parents what is true for them right now, “You have a healthy child.”

Trinidad, Antolin C.

doi: 10.1001/jama.2010.1556pmid: 21063002

My faculty practice organization renovated the building it owns. A massive redecoration of the offices occurred. As part of this process, we all had to take down everything from our walls so they could be repainted. All of the pictures, certificates, and sundry tchotchkes came down, boxed and relegated to an empty and unused office for the month or two that this process unfolded. The walls are now a pristine off-white. A signal was shortly given that it was time to rehang what needed to be rehung. This seemed the least of my priorities, and the certificates languished for another month in a dark corner, almost forgotten until a patient remarked that I needed some pictures on my walls because they seemed too stark and sterile. That was my second signal, and so I went to the office one weekend to do the task. I was desultory, uneven, and regretting the act of marring the pristine walls with holes. Did I really need to hang these things? If anyone cared to inspect my credentials, he or she could simply go online. For a moment, I romanticized the minimalist look, fantasizing a sleek and decoration-free existence whose subtle contours serenely project a Zen-like ambience to my daily routines. How different things were at the time when I was first setting up practice. I remember a rather lengthy deliberation with a colleague, also setting up practice and also a psychiatrist with a brand-new board certificate, on what frames to pick for our certificates, what textured matting complemented the paper of the certificates and diplomas we were excitedly about to hang proudly on the walls of our first offices. My colleague did a rather impressive research on frames and matting, and she zeroed in on what she called a “Cadillac” frame for her board certificate, a stunning number executed in oak with subtle velvet piping. The mat was a heavy, marbled paper whose provenance was clearly some lonely tree that survived only in an endangered forest in the Pyrenees. It probably cost the equivalent of my whole year's salary when I was an intern. In my subsequent peregrinations, moving to various offices and practice settings, the certificates were the ones that went up even before the cables and computer hookups were working, second in priority only to the acquisition of a working telephone line. This time, I contemplated them with an eye on which certificate could be deframed and relegated to a folder in a drawer somewhere. The board certificate seemed important; it declared my right to call myself a psychiatrist, properly trained at a respectable institution, tested and passed accordingly. And anyway I spent so much capital of worry and obsession on passing—and on that nagging doppelgänger of a possibility of flunking—that board examination. So I punched a hole in the wall, propelled by the energy of a righteous resolve, and up it went first. The residency and the fellowship certificates were difficult to decide on. I clearly passed the boards, so obviously I finished residency—did I really need to hang these proofs? I decided that they balanced rather well on each side of the board certificate. Up they went. I have a master's degree in English literature. It has always seemed out of place in this grouping, so could it be jettisoned? But I have always been proud of it, obtaining the degree while already in practice in an effort to complete my education lopsidedly dominated by the sciences. It was up there in my life's accomplishments along with running a marathon. Up went the master's degree on the wall. In the end all the certificates went up, all the material metaphors of an education marking the passage of a considerable length of time spent in schools. As I surveyed the results, I thought that these certificates are not for anyone else but for me. They mark the thousand bits of anecdotes that accompany the nodes in a physician's formal education like a wall-sized scrapbook. Occasionally a patient or two would absentmindedly glance at them. We share very little of our lives with patients—indeed even with colleagues—and our walls are one (if not the only) way of sharing. I know of an internist whose walls are full of framed pictures he took of his vacations. Often other colleagues have pictures of their families along with their certificates. Through the symbolic resonances of the wall hangings we create within our offices, our patients and our colleagues glimpse a small view of our lives. Along with a medical education, I think we learn to underplay the narratives of our lives to a whisper, thinking perhaps that the lives of others are always the priority. But occasionally the whisper becomes a tad louder, and we hear again the narrative of our own individual stories—for example, during times when we rehang our certificates on a freshly painted wall.

Mitka, Mike

doi: 10.1001/jama.2010.1603pmid: 21063003

Risk calculators can be useful tools in the preventive care arsenal physicians use in assessing and treating patients for certain conditions. But calculators can achieve their full utility only if they are calibrated correctly and if patients have access to treatment strategies that truly minimize a risk. Access to personal computers and digital assistance devices makes it easy for physicians to use the current gold standard for assessing heart risk, the Framingham scoring system. Members of National Heart, Lung, and Blood Institute (NHLBI) expert panels are considering these issues as they revise guidelines surrounding risk assessment and treatment strategies for cardiovascular health. The updated guidelines for cholesterol, hypertension, and obesity are scheduled to be ready for public review and comment in the spring of 2011, with an expected release that fall. The NHLBI ultimately hopes to combine these guidelines into one integrated cardiovascular risk reduction guideline. The current gold standard for cardiovascular risk assessment is the Framingham risk scoring system, a calculation providing an individual's 10-year risk of myocardial infarction or coronary death based on data generated through the Framingham Heart Study. The Framingham system takes various data points—age, sex, levels of total cholesterol and high-density lipoprotein cholesterol, smoking status, and blood pressure readings—and categorizes an individual's risk level as low (a less than 10% chance of myocardial infarction or coronary death over 10 years or less), intermediate (10%-20%), or high (more than 20%). The Framingham system has flaws, as significant percentages of individuals who would be considered at low risk go on to have a myocardial infarction or coronary death, and significant numbers of those in the high-risk group do not. Given these outliers, it is not surprising that various groups over the years have proposed improving the system's predictive accuracy by adding nontraditional markers such as ankle brachial index, fasting blood glucose, and coronary artery calcification. But last year the US Preventive Services Task Force said it could not recommend using nontraditional markers because a lack of evidence leaves their validity in question (US Preventive Services Task Force. Ann Intern Med. 2009;151[7]:474-482). Efforts to improve on the Framingham model should remind physicians to ask basic questions about the use of calculators for assessing cardiovascular risk and determining treatment, said Philip Greenland, MD, professor of medicine at Northwestern University's Feinberg School of Medicine in Chicago. “What is the most accurate way to evaluate cardiovascular risk?” Greenland asked. “And if we improve risk assessment as best as we possibly can using modern technologies and applying it to practice, do we know it will actually make a difference in long-term outcomes?” Correct use While the Framingham scoring system remains the gold standard, new research suggests that the system is being used in a suboptimal manner. Framingham results can be calculated in 2 ways. The traditional method requires computations involving a complex mathematical equation. The points method assigns scores to the measured factors, allowing for quick and easy placement of an individual into the various risk categories. Michael A. Steinman, MD, assistant professor of medicine at the University of California, San Francisco, and colleagues conducted research comparing risk category placement based on the points system with placement based on the traditional method (Gordon WJ et al. J Gen Intern Med. doi: 10.1007/s11606-010-1454-2 [published online ahead of print September 8, 2010]). The researchers assessed 2543 individuals aged 20 to 79 years from the 2001-2006 National Health and Nutrition Examination Surveys, for whom Adult Treatment Panel III (ATP-III) guidelines (the NHLBI's cholesterol guidelines) recommend formal risk stratification. They found that the points method misclassified 15% of those assessed, with about 10% appearing in a higher risk category and about 5% in a lower risk category. “The lesson from our paper is generalizability; when you take a continuous risk function and you convert it into a points-based system—and there can be good reasons to do so, such as ease of use—you can introduce error,” Steinman said. “And such errors may mean that some people will be overtreated and others undertreated.” The solution to this discrepancy is fairly simple, Steinman said. With personal computers and personal digital assistance devices accessible to most physicians, a programming download should make the traditional Framingham method available in an easy-to-use fashion. “When you have a computer available, it is better to use a more accurate system,” Steinman said. Ralph B. D’Agostino Sr, PhD, senior statistician and coprincipal investigator with the Framingham Heart Study and a professor of mathematics at Boston University, said he felt the article by Gordon et al overstates the discrepancy between the methods of assessing risk, but does agree that it is preferable to use the traditional method over the points method. “I am the first one to say that the point system is only an approximation, and if we can get physicians and people to use the real thing, that is better,” D’Agostino said. Greenland offered a caveat to the entire discussion of using Framingham correctly, noting that the Gordon et al article did not address whether better classification using the traditional method reduced the number of hard outcomes for myocardial infarction and coronary death. “Changing categories of risk is not the ultimate goal,” Greenland said. “Changing the categories more accurately—that is the holy grail.” Peter W. F. Wilson, MD, professor of medicine and public health at Emory University in Atlanta, is not as concerned about potential misclassifications, and said the key for physicians is repeated testing. “Whenever you assess anything you get a margin of error, and what do we do about error and how do we interpret the measurements we find?” asked Wilson, who was director of laboratories at the Framingham Heart Study from 1983 to 2003. “For risk estimation, we should be careful about labeling people into major categories. Risk estimation gives people an opportunity for dialogue, so they can then converse with doctors, nutritionists, health educators, whomever, to discuss what should be done next.” Spurring conversation is especially useful for older adults because the benefits of calculating risk and acting on that risk have not been studied rigorously. For younger adults, the benefit of assessing risk through calculation also requires additional conversation because typically, risk calculators are not as accurate in this population. D’Agostino said traditional risk assessment for the vast majority of young adults will show their 10-year chances of having a myocardial infarction or coronary death as minimal, but that does not mean that they are not headed for cardiovascular complications later in life. “We can now tell a healthy 35-year-old woman, for example, by looking at these risk factors, that she has the heart of a 50-year-old,” D’Agostino said. “That can get her attention to perhaps change her lifestyle now instead of waiting until the risks are higher.” D’Agostino added that physicians need to be careful, however, not to overmedicate people who may not warrant aggressive lifetime therapy, but who may then end up on treatments for decades. What is the benefit? Greenland's question—whether using risk calculators and acting on the findings reduce adverse outcomes—remains the elephant in the cardiology room. Rigorous studies validating the premise remain lacking. But in the meantime, patients will be assessed and treated with the best evidence available. “If I predict your risk is elevated and put you on treatment, can I expect better outcomes related to the treatment?” Greenland asked. “We have come to these recommendations about measuring risk factors and treating risk factors, and we have pretty good evidence that if we treat, we do lower risk.” While such questions remain unanswered, the NHLBI expert panels continue working on the guideline updates. Wilson, who is a member of the panel working on ATP-IV, declined to discuss specifics of his group's activity, but offered his views on what needs to be considered. “We are definitely behind the idea of lifestyle modification first,” Wilson said. “Medications for cholesterol control are now available at lower costs, but if you eat a proper diet, you can really control your cholesterol.” Moving beyond the short-term guidelines expected to be released next year by the NHLBI, physicians and the public can hope for the agency to issue an integrated cardiovascular risk reduction guideline shortly thereafter. D’Agostino said such a one-stop shop for risk assessment makes sense. “A patient will tell the doctor, ‘Do not tell me I am at low risk for a myocardial infarction and not mention that I am at high risk for a stroke,’” D’Agostino said. D’Agostino, who has worked with some of the NHLBI expert panels, speculated they will seek to develop some type of global assessment that will estimate risk for myocardial infarction and coronary death and include other outcomes such as congestive heart failure and stroke. Such an assessment will probably not come just from studying data from the Framingham scoring system, he added. “At one point, Framingham was the only game in town,” D’Agostino noted. “But now we should see how we can put [together] all this data from various study populations.”

Mitka, Mike

doi: 10.1001/jama.2010.1604pmid: 21063004

The science as understood today is clear—stent placement to relieve symptoms of angina in patients with stable coronary artery disease does not reduce the risk of myocardial infarction when compared with optimal medical therapy. But a new, small study finds this information is not successfully communicated to patients. It found that most patients with stable coronary disease, all of whom went through the informed consent process with their cardiologists, still believe percutaneous coronary intervention (PCI) will reduce their myocardial infarction risk. The findings also suggest that a significant percentage of cardiologists believe stenting lowers myocardial infarction risk in this population. Physicians may think they clearly communicate the benefits and risks of various treatments, but too often patients hear something else. The study, by researchers from Tufts University School of Medicine in Boston and its Baystate Medical Center in Springfield, Mass, found that among 153 surveyed Baystate patients who consented to elective coronary catheterization and possible PCI, 88% believed PCI would reduce their risk for myocardial infarction and 82% thought it would reduce their risk for a fatal myocardial infarction. At the same time, 96% of patients said that they knew why they might undergo the procedure, with more than half saying they were actively involved in the decision-making process (Rothberg MB et al. Ann Intern Med. 2010;153[5]:307-313). Michael B. Rothberg, MD, MPH, lead author and assistant professor of medicine at Baystate Medical Center, said the study emphasizes the continuing disconnect when physicians talk to their patients. “It means that patients do not understand as much as we assume that they do,” Rothberg said. “Physicians do not explicitly say what a procedure will not do, and in this case, this is a concern because many patients probably assume PCI will reduce heart attack risk without ever hearing that from their physicians.” Alicia Fernandez, MD, who wrote an editorial on the study (Fernandez A. Ann Intern Med. 2010;153[5]:342-343), said Rothberg's findings show that the informed consent process remains suboptimal. “Every couple of years, we need to rediscover this problem and hopefully think of ways to improve the situation,” said Fernandez, an associate professor of clinical medicine at the University of California, San Francisco. But while patients' overestimation of the benefits of PCI may be attributed to their failure to understand what a physician discusses with them, in some cases it may be the physicians themselves who are distorting the information due to their own biases. Rothberg's study also surveyed 27 cardiologists who interacted with the surveyed patients. They were asked what treatment course they would take regarding scenarios in which a patient presents with variations of stable angina. While 70% of the cardiologists correctly did not find any benefit other than symptom relief associated with PCI (meaning 30% did), 43% of them said they would proceed to PCI anyway. Rothberg speculated about the reasons some cardiologists still opt for performing PCI: they may be convinced that PCI does reduce myocardial infarction risk and that studies showing differently are based on obsolete technologies; they may fear lawsuits if they do not perform PCI; financial incentives may lead them to push for PCI; or patients may demand the procedure. Rothberg added that the current diagnostic-therapeutic cascade, in which, for example, an abnormal stress test leads to diagnostic catheterization and immediate PCI if coronary blockage is observed, puts the patient at a distinct disadvantage for discussing the pros and cons of various treatment options for stable coronary artery disease. “There are advantages in that a patient does not need to come back another day and receive 2 groin sticks, but the downside is there is no time for reflection.” [see Commentary on page 2059]. Rita F. Redberg, MD, MSc, a professor of medicine at the University of California, San Francisco, who agrees with Rothberg's reasons for cardiologists still performing PCI in this population, said patients are at a distinct disadvantage in making rational decisions while undergoing diagnostic catheterization. “People love technology; they love pictures,” said Redberg, who is also editor of Archives of Internal Medicine. “And if you have a physician ready to implant a stent, saying ‘I can fix your artery,’ well, there is something pleasing about seeing a blockage and then seeing it being opened.” Fernandez noted there are ways to improve informed consent and the discussion of risks and benefits of any treatment course.” Such methods, she said, should be especially considered when treating vulnerable patients, such as those who speak a foreign language or those with little education.

Voelker, Rebecca

doi: 10.1001/jama.2010.1605pmid: 21063005

With an infusion of almost $30 million in new federal funds, a network of clinicians and basic scientists hopes to unravel more of the knotty threads that for years have tied researchers' hands in the search for effective ways to prevent and treat food allergies. A gene on chromosome 5 that encodes thymic stromal lymphopoietin has been linked with eosinophilic esophagitis, a condition under study as part of expanded food allergy research. New funding announced earlier this year, from the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), will enable the Consortium of Food Allergy Research (CoFAR) to embark on new studies on the genetics of food allergy and related conditions known as eosinophilic gastrointestinal diseases. Since the NIAID and NIDDK established CoFAR in 2005, the consortium has launched an observational study and 3 clinical trials examining aspects of peanut, egg, and milk allergies. The NIAID estimates that 5% of children and 4% of adults in the United States have food allergies, and studies suggest the prevalence is increasing. “Food allergy is considered a major public health problem, and is one for which we don't have any recognized ways to prevent or treat the disease,” said Marshall Plaut, MD, chief of the Allergic Mechanisms Section at the NIAID. CoFAR's new genetics component will build on research that investigators at Children's Memorial Research Center in Chicago and Boston University have conducted for the past 5 years. More than 1000 Chicago families and 6 500 mother and infant pairs in Boston are involved in the genome-wide association study. Another study site, in China, includes 800 Chinese twin pairs. Xiaobin Wang, MD, MPH, ScD, principal investigator of the CoFAR genetics studies and director of the Smith Child Health Research Program at Children's Memorial, said research on these cohorts already has yielded several published studies about novel risk factors associated with food allergy, including a link between gestational diabetes and early childhood allergen sensitization to common foods (Kumar R et al. J Allergy Clin Immunol. 2009;124[5]:1031-1038). “We're trying to understand the fundamental questions: what are the causes, what is the etiology, and what are the biological mechanisms that lead to food allergy?” said Wang. “This is a very complicated puzzle.” Wang's group is trying to identify specific genes associated with food allergy. “Very little is known about this,” she said. Her group has unpublished data from which genes have been identified that regulate immunoglobulin E (IgE), the critical mediator of allergic responses, in cord blood. “That's a link to the development of food allergy,” she noted. Her group also is examining whether the same genes are involved in all food allergies or if specific genes are linked with specific food allergies. “We have preliminary data supporting both cases,” she said. “It looks like there are some common genes and some specific genes to each type of food allergy.” In a separate CoFAR genetics project, researchers at Cincinnati Children's Hospital Medical Center, the University of Colorado, and Children's Hospital of Philadelphia are examining the genetic factors related to the development of eosinophilic esophagitis (EE), a disorder characterized by chronic inflammation and swelling in the esophagus that is triggered by food antigens. “It's unique from classic food allergy in terms of the mechanisms and the clinical symptoms, but it is related in the broad category of food allergy,” said CoFAR project leader Marc E. Rothenberg, MD, PhD, director of the Division of Allergy and Immunology at Cincinnati Children’s. Rothenberg and his colleagues in Cincinnati already have published data on several genes linked with EE, including a study earlier this year that implicated the gene on chromosome 5 that encodes thymic stromal lymphopoietin (Rothenberg ME et al. Nat Genet. 2010;42[4]:289-291). The CoFAR research will build on these and other related data. “We are proposing to compare the genetic components of basic food allergy with the components we’ve identified [in EE],” said Rothenberg. His group will analyze DNA samples from individuals participating in clinical studies at all of the CoFAR sites. Hugh Sampson, MD, clinical project leader of CoFAR and dean for Translational Biomedical Science at the Mount Sinai Medical Center in New York City, said investigators at all the study sites view their work as a great opportunity to develop effective therapies for patients with food allergy. “We’ve all taken care of food allergy patients for a long time and until recently all we’ve been able to do is tell them they have to avoid [certain foods] and how to take care of themselves if they have accidental ingestion,” he said.

Mitka, Mike

doi: 10.1001/jama.2010.1606pmid: N/A

Sen Herb Kohl (D, Wis), chairman of the Senate Special Committee on Aging, wants to know if CVS Caremark Corp is responsibly administering drug benefits as required by the Medicare Part D prescription drug program. CVS Caremark was formed in 2007 through the merger of CVS, the largest retail pharmacy chain in the United States, with Caremark Rx Inc, one of the nation's largest pharmacy benefit managers. The new company's benefit services include integrating network pharmacy claims processing, benefit design consultation, drug use review, and formulary management. In a September 21 letter to Thomas M. Ryan, who is chairman of the board, president, and CEO of CVS Caremark, Kohl said his committee had received numerous reports from seniors claiming to have been steered to CVS retail or mail-order pharmacies based on promises of lower out-of-pocket costs, only to encounter higher co-pays as well as higher drug charges to Part D plans (http://bit.ly/bqI0J4).

Mitka, Mike

doi: 10.1001/jama.2010.1607pmid: N/A

Participants in a forum hosted by the Government Accountability Office (GAO) tackled the barriers facing people with disabilities seeking employment with the federal government. (Photo credit: Wesley VanDinter/iStockphoto.com) Measures to reduce barriers faced by people with disabilities seeking jobs with the federal government were discussed at a forum hosted by the Government Accountability Office. Following the July 20 forum, which included individuals knowledgeable about such barriers and ways to combat them, the GAO identified several practices that agencies could implement to help the federal government become a model employer for people with disabilities. The forum, which came about through the request of leadership of the Senate Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia, coincided with the 20th anniversary of the enactment of the Americans with Disabilities Act. Among the GAO's conclusions were: top leadership commitment is key to implementing and sustaining improvements; accountability is critical to success; regular surveys of the workforce on disability issues provides agencies with important information; career development opportunities inclusive of people with disabilities could facilitate advancement and increase retention; and a flexible work environment can increase and enhance employment opportunities for these individuals (http://bit.ly/bruJym).