JAMA

doi: 10.1001/jama.299.23.2715pmid: N/A

Depressive Symptoms and Diabetes In an analysis of data from a longitudinal cohort study of men and women aged 45 to 84 years, Golden and colleagues examined the bidirectional association between depressive symptoms and type 2 diabetes. The authors report that a modestly increased risk of incident diabetes among persons who had depressive symptoms at baseline was partially explained by lifestyle factors. They also found that baseline impaired glucose tolerance and untreated diabetes were inversely associated with incident depressive symptoms, whereas persons with treated diabetes were at increased risk of developing elevated depressive symptoms during follow-up. Article Salvage Radiotherapy and Prostate Cancer Survival Patients with a biochemical recurrence after radical prostatectomy often have salvage radiotherapy, but it is not known whether this treatment improves survival. In a retrospective analysis of 635 men who developed recurrent disease following radical prostatectomy for clinically localized prostate cancer, Trock and colleagues assessed prostate cancer–specific survival following a biochemical recurrence, local recurrence, or both in men who had salvage radiotherapy alone or combined with hormonal therapy vs no therapy. The authors report that 116 men died of prostate cancer during a median follow-up of 6 years following recurrence. The authors found that compared with no salvage treatment, salvage radiotherapy administered within 2 years of biochemical recurrence was associated with a significant increase in prostate cancer–specific survival in a subgroup of men whose prostate-specific antigen doubling time was less than 6 months. Article Atypical Type 2 Diabetes and Herpesvirus 8 Infection An atypical form of type 2 diabetes mellitus (“ketosis prone”) has recently emerged in persons who are black and of African origin. In a cross-sectional study of adult patients living in France who were born in sub-Saharan African, where human herpesvirus 8 (HHV-8) is endemic, Sobngwi and colleagues investigated the association of HHV-8 infection with ketosis-prone type 2 diabetes. The authors found a significantly higher prevalence of HHV-8 antibodies and the presence of HHV-8 viremia at disease onset in patients with ketosis-prone type 2 diabetes compared with patients with nonketotic type 2 diabetes or nondiabetic controls. Article CLINICIAN'S CORNER CETP Genotype, Lipid Levels, and Coronary Risk Cholesteryl ester transfer protein (CETP), which is involved in the exchange of cholesteryl esters for triglycerides, has been a target in new drug development for prevention of coronary disease. However, the safety of CETP inhibitors has been called into question, and whether these agents warrant further study is uncertain. Thompson and colleagues Article report the results of meta-analyses to assess the associations of 6 CETP genotypes with CETP activity, lipid levels, and coronary risk. Among the authors' findings is that several common CETP genotypes associated with moderate inhibition of CETP activity—and thereby modestly increased high-density lipoprotein cholesterol levels—have weakly inverse associations with coronary risk. In an editorial, Wilson Article discusses how summary analyses of genotypes, metabolic information, and clinical outcomes enhance understanding of environment and gene interactions in disease causation. A Piece of My Mind “Fear is palpable when disease is present, always percolating beneath a veneer of illusory calm.” From “Wanting.” Article Medical News & Perspectives Companies using the Internet to speed recruiting of patients for clinical trials may open clinical research to more patients, but critics worry that inadequate regulation of the approach may put patients' interests at risk. Article Commentaries “Perfect storm” in health care Article Illegal use of growth hormone Article Author in the Room Teleconference Join Sherita Hill Golden, MD, MHS, July 16 from 2 to 3 PM eastern time to discuss the bidirectional association between depressive symptoms and diabetes. To register, go to http://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. Readers Respond How would you manage a 70-year-old man with severe coronary and peripheral artery disease who presents with acute-onset slurred speech and left facial droop? Go to www.jama.com, read the case, and submit your response, which may be selected for online publication. Submission deadline is June 25. JAMA Patient Page For your patients: Information about weight and diabetes. Article

Southgate, M. Therese

doi: 10.1001/jama.299.23.2720pmid: 18559991

Although women have always been underrepresented in the canons of Western art, it was during the 19th and 20th centuries especially that it was difficult for a woman to gain recognition as a serious painter; although many pursued their art and had professional, even academic training, not to mention the rare one-woman exhibit, most remained unknown and would be so today were it not for the efforts put forth in recent decades by devoted collectors and scholars. Such is the case with the early 20th-century American painter Beatrice Whitney Van Ness (1888-1981). Despite her long career (she was 91 when she put down her brushes for the last time), her 7 years of study at the School of the Museum of Fine Arts in Boston with leading painters such as Edmund Tarbell, Frank Benson, Philip Hale, and later with Charles Woodbury, her five one-woman exhibitions, at least two major awards (one from the National Academy of Design, New York; the other the Silver Medal at the prestigious Pan-Pacific Exposition in San Francisco in 1915), and numerous other prizes, Mrs Van Ness (as she was often referred to) remains little known today. Were it not for research by the National Museum of Women in the Arts and the catalogue of its permanent collection, we would know even less. Beatrice Whitney Van Ness (1888-1981), Summer Sunlight, circa 1936, American. Oil on canvas. 99.1 × 124.5 cm. Courtesy of the National Museum of Women in the Arts (http://www.nmwa.org), Washington, DC; gift of Wallace and Wilhelmina Holladay. On the other hand, perhaps these statistics, including the fact that at age 27—the same year she won the Silver Medal—she married Carl Norwood Van Ness and afterward had two daughters, are just so much window dressing, the “frame” around her soul, so to speak. The “true” life of Beatrice Whitney Van Ness is actually a labyrinth that winds through a long succession of paintings, one, for example, Summer Sunlight (cover). Painted sometime around 1936, when Van Ness would have been in her late 40s, the work depicts an intimate, domestic scene, one that could have occurred—and probably did occur— almost daily at her island home at Bartlett's Harbor in North Haven, Maine, where the family summered each year. For Beatrice Van Ness, the scene was as commonplace as Monet's haystacks were to him. It was this very fact of familiarity with her motif that left her free to experiment with color and line, as well as with composition and brushstrokes. The persons in the painting have been identified as Van Ness' older daughter (center, hatted), her nephew, Winthrop Stearns (his back to the viewer), and at the left, just entering the picture (with a yellow banana in her outstretched hand), her neighbor, Barbara Allen. But these ruddy, parboiled figures are hardly the painting's subject. The subject is light: brilliant, harsh, painful, blinding summer beach light. Van Ness emphasized these properties with bright, electric yellows and incandescent oranges contrasted with a deep ocean blue and paler blue bench. Within the composition, forms echo one another: a shard of yellow cutting into the umbrella's rim is repeated with a shard of cloud cutting into the same umbrella and again with a barely visible triangular sail. The triangle of oceanic blue at the upper left is repeated in the softer and paler blue neckline of the Allen figure's bathing costume. Likewise, the form of the orange ribbon around the daughter's neck is repeated in the straps of her cousin's bathing suit. At the right, a sturdy brown umbrella support intrudes diagonally across the canvas, serving not only to anchor the composition but to isolate the young man from the women's domain. The most pronounced diagonals, however, and therefore those that give the most motion to an otherwise static scene, are the ascending progression of heads from right to left and the parallel diagonal of the umbrella's edge. Van Ness was a longtime resident of Brookline, Massachusetts. Besides painting, her other major activity was teaching, a career she began at the School of the Museum of Fine Arts while she was still a student there. In 1921, she founded a unique art program at the Beaver County Day School in Chestnut Hill, Massachusetts. She directed the school and taught there for nearly 30 years. In addition, she taught at several other local schools and wrote extensively on art education. She died in 1981, aged 93.

Neilson, Shane

doi: 10.1001/jama.299.23.2721pmid: N/A

Your hands: grand rotting cathedrals, buckskin inebriate Brillos, two huge cowcuffers. I once watched them rend plywood, hammer spikes into blocks, every test a fight, the carpentry learned in the army. The black-white photograph: your big mitts taped up and shoved into boxing gloves. Now your hands are demented, they fly at buttons, they skitter and slapdash, they are shells, relics of purpose. We put together the bookshelf plank by plank, and those airplane wings are undecided, fumble with a nail, drop a hammer. You with the tremor and the grip strength of irony, with paretic limbs. Each screw excruciates, won't go in, won't tighten. I take the driver from you. You look to me to tell you next, and I tell you what I never thought I would: Let me handle it.

Rousseau, Paul

doi: 10.1001/jama.299.23.2722pmid: 18559992

The want to be well permeates a person's life when the first sign of disease knocks on the door of invincibility. I know this not because I am a physician, but because I accompanied a loved one on a far-too-short journey through the horror and poverty of disease. I saw her fear, her suffering, and her eyes filled with the fading of light—she wanted nothing more than the normalcy of good health. Pamela was 51 years old, an accountant, and the mother of our two daughters. She was a nonsmoker and an exerciser, with a fairly benign medical history except for an aunt with multiple sclerosis and a cousin with Crohn disease. She was a stickler for details, a characteristic that can indubitably worsen the apprehension surrounding the significance of symptoms, as I’m sure it did with her. And although Pamela was blessed with a supportive family, disease and death are lonely companions that humble our arrogance and introduce us to the numbing realities of humility and mortality. Her verbal journal is unsettling and tells such a tale. “It started with a cough, nothing much, but it didn't improve. After multiple treatments for allergies that have done little to lessen the cough, I am concerned. Now the cough is a persistent and worsening fear, my mind a fuel gauge chronicling the severity of my cough from minute to minute.” Symptoms present a dichotomy—they are an intrinsic alarm that something is wrong, but they're also an annoyance that evolves into an underlying fear— a fear for the fragility of today, a fear for the uncertainty of tomorrow, and a fear for the promise of suffering. We trust our bodies, and when disease violates our physical sanctity, we feel betrayed and at a loss as to how this could have happened—and why. “Next thing I know, I’m having a bronchoscopy, then an open lung biopsy. The fear is immeasurable, it is present day and night. I have two daughters, I don't want to die, what will this mean? Will it mean I will never see them marry, have children, and be called Grandma?” Fear is palpable when disease is present, always percolating beneath a veneer of illusory calm. A large part of fear is the unknown, not knowing what monster lies within or what the future holds. And there is always the wanting, a wanting of normalcy, a wanting of good health when the nagging pathology vacates and allows a return to the reassuring milieu of wellness. We bargain, we make promises, we cajole, we pray, we do whatever we can in the hope that health may return. And we worry—we think of our symptoms continuously; in fact, we can't stop thinking of them—it's like an annoying mosquito that buzzes in our ear. Sleep becomes our only respite. “After the open lung biopsy, a subcutaneous pneumothorax, a wound infection, and an interminable wait of three weeks for biopsy results, I was given my sentence: probable scleroderma, with primary involvement of my lungs. Yes, there was some relief with knowing, but it was a presumptive diagnosis—not even Mayo Clinic could be certain after reviewing the pathology slides. But irrespective, I was introduced to some new friends: cyclophosphamide, ondansetron, prednisone, alendronate, omeprazole, furosemide, and others whose names I cannot remember.” The wanting intensifies with an initial diagnosis if it is something more than a temporary inconvenience. Suddenly, the days are consumed by this newfound sickness, this tentacle of restlessness that suffocates the joy of living. The mind longs to have things like it used to have, when health was a daily anticipation without the garnishes of fear and want. “Six months into the chemotherapy, and my life forever changed, I wonder what the next day holds—will I be sicker, will I be better, or will I die? I still want to be healthy, but the waste of my disease has kept me occupied—no longer do I have time to think of being well other than those moments when I am mentally and physically exasperated from the shortness of breath, the cough, the multitude of pills.” Unfortunately, wanting, while a powerful aphrodisiac, slowly disappears and is gradually supplanted by the grim reality of a life-threatening disease. Normalcy and good health seem miles away and no longer obtainable or even accessible for a brief respite, relegating the future to uncertainty and the brittle scaffold of coping. “I always feared what would happen, what could happen—now, my disease has suddenly worsened after a year of chemotherapy. I cannot walk down a few stairs without suffocating. My heart is erratic, my legs swollen, my fingers eaten by ulcers. I fear I am dying—no one says that, but I feel it.” Once wanting is gone, what is left? Certainly, there are people who allegedly pay little heed to wanting and charge full speed into acknowledging, confronting, and battling their disease. I’m sure that's what many patients do when first diagnosed. Still, when wanting is gone and illness has tempered the battles of resistance, many acquiesce to their plight and quietly write their memoirs in the sweat of sickness. Pamela's wanting seemed to dissipate, at least outwardly, as her disease progressed—she died a mere 18 months after diagnosis. Did she want good health as she lay dying?—I am certain she did—but I am also certain that she had moved on to dealing with the daily wreckage of a horrible and debilitating disease long before her death, realizing good health was a distant dream never to be realized.

Kuehn, Bridget M.

doi: 10.1001/jama.299.23.2733pmid: 18559993

Pharmaceutical companies are outsourcing the recruitment of patients for some clinical trials to companies that use Web sites for the purpose of collecting personal and medical data on prospective participants and screening them for suitability. But some critics of the practice are concerned that the tactics being used may put patient privacy or the integrity of clinical research at risk. Traditionally, patients have been recruited for clinical trials through their physicians or via advertisements that direct them to contact the clinicians conducting the trial. More recently, Web sites that simply list or advertise clinical trials have become a common recruitment tool for both privately and publicly funded clinical trials. But a drive by pharmaceutical companies to reduce costs, test more experimental drugs, and speed the development process has encouraged more aggressive strategies for patient recruitment. In this environment, an “industry” devoted to patient recruitment has emerged, fueled in part by health Web sites that collect and sell personal and medical information. Such companies state that their targeted strategies and vast databases of information about patients willing to participate in clinical trials reduce research costs and help speed one of the most time-consuming aspects of conducting a clinical trial. But some physicians and academicians are concerned that patients may not fully understand the risks of divulging so much private information online and that aggressive recruitment strategies may compromise trial quality or damage the reputation of clinical research. Selling patient data As patients increasingly turn to the Internet for medical information, companies and scientists involved in clinical trials have looked for ways to use this network as a recruiting tool. Some efforts have simply extended to this new medium traditional clinical trials outreach, including posting trial information and contact information in places such as the National Cancer Institute's searchable database of cancer trials currently recruiting patients (http://www.cancer.gov/clinicaltrials) and commercial listing services such as CenterWatch (http://www.centerwatch.com). Such Web sites allow patients to browse trial listings without requiring them to disclose personal or medical information. Companies dedicated solely to patient recruitment also have emerged and use Web sites as part of sophisticated recruiting campaigns. For example, one such company, Acurian, Inc (Horsham, Pa), maintains a database of personal and medical information on more than 40 million patients who are willing to be contacted for participation in clinical trials. In some cases, Acurian recruits patients for specific trials. For example, the company recently ran television advertisements for a trial of a experimental treatment for constipation in patients taking opioid medications for chronic noncancer pain, directing patients to a Web site or telephone number for more information. The Web site (http://www.gitrial.com) notes that the trial is assessing a drug for opioid-induced constipation vs placebo, provides some basic criteria for participation, and directs patients to a screening survey that collects personal and medical information. The site does not, however, indicate who is sponsoring the trial, what phase it is, or potential risk or benefits. The advertisement, Web site, and screening questions were reviewed by a commercial institutional review board (IRB), said Scott Connor, vice president of marketing at Acurian. Patients who qualify for participation based on their survey answers will be referred to a study site, where the informed consent process will take place, Connor said. Those who do not qualify will be asked whether they would like their information included in the database for other clinical trials, Connor said. Additionally, Acurian works with other companies that collect patient data, some of which operate their own consumer-based Web sites or conduct telephone surveys. Some consumer-oriented Web sites also are profiting from the recruitment of patients for clinical trials. Patient rights But such commercial online recruiting attempts also have stirred up criticism that such ventures may put patients' interest at risk. In 2000, a report by the Department of Health and Human Services' Office of Inspector General (OIG) explored the trend of more aggressive clinical trial recruiting and noted that informed consent or patient confidentiality may be compromised in the drive to recruit trial participants more quickly (http://oig.hhs.gov/oei/reports/oei-01-97-00195.pdf). The report noted particular concerns about persons other than a patient's physician searching a database containing that patient's medical information, and about how patient privacy is maintained when call center screeners collect patient data prior to informed consent. Such concerns may arguably extend to Web-based operations. A 2002 OIG report focusing on Web sites recruiting participants for clinical trials found that many sites fail to include such key information as the risks and benefits of participating, the sponsor or phase of the study, or a general description of the protocol. The report also noted that some sites' privacy policies failed to indicate how long patient data would be stored or did not describe the processes used to protect information submitted online. Many sites did not disclose how they generate revenue. Commercial online recruiting sites that collect patient data without providing key information such as the study's sponsor or terms are worrisome, said Peter D. Jacobson, JD, MPH, professor of health law and policy at the University of Michigan School of Public Health in Ann Arbor. Patients have no way to know whether their information is being collected by legitimate researchers and what it will be used for, he noted. “You have people who are unsuspecting providing information to a Web site whose source is unknown,” he said. “It's seriously troubling from both a recruitment and a privacy standpoint.” There also are concerns about companies that screen patients and collect data prior to the informed consent process. Curt Furberg, MD, PhD, professor in the department of public health sciences at the Wake Forest University School of Medicine in Winston-Salem, NC, explained that when physicians or trialists recruit patients for studies, they discuss the purpose of the trial and answer any questions as part of the informed consent process. “It's important that patients are getting full information about what they are getting into and that everything is explained, and that they sign that they are in agreement,” he said. Physicians or other clinicians who recruit patients for a trial have ethical obligations to consider the patient's interests that might not be observed by commercial entities that recruit patients for trials, Furberg said. “There's a profit motive behind setting up sites, and when they profit, I’m not sure they protect the patients' interests,” he said. “They have their own interests.” Regulation questioned Both Furberg and Jacobson also expressed concern about how recruiting companies and Web sites collecting data are regulated. Such companies are not covered by the Health Insurance Portability and Accountability Act, which governs patient information obtained by clinicians and medical centers. Connor said that Acurian is not regulated by the FDA, but that http://www.gitrial.com and the screening questions used on that site were reviewed by an IRB. In fact, a 2007 report by the OIG noted serious limitations in the FDA's oversight of clinical trials (http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf). For instance, the FDA has the authority to take action against clinical investigators, but not other individuals who the investigator may charge with various aspects of the trial. Also, the FDA inspected about 1% of the clinical trial sites it is charged with regulating and audited about 6% of the IRBs regulated by the agency during the period between 2000 and 2005. But others feel existing protections, such as IRB review and oversight by trial sponsors, are enough and that online recruitment may aid the clinical trials process and allow patients to take a more active role in their health. Jeffery Probstfield, MD, professor of medicine at the University of Washington School of Public Health and Community Medicine in Seattle, said the Web sites that collect patient data are similar to companies that send out mass mailings to prospective participants and compile lists for sale to trialists. In Probstfield's view, patients recruited through these sites who agree to participate in trials ultimately will be protected when they sign the informed consent form for the trial, which limits how their information can be used. “Participation activities like this, which could conceivably make recruitment easier, are very worthwhile as long as the patient signs a consent form later on that describes what their obligation would be,” he said. Ken Getz, MBA, a researcher at the Center for Study of Drug Development at Tufts University and founder and former CEO of the commercial listing service CenterWatch, also emphasized the layers of oversight already in place, such as IRBs and federal regulations governing clinical studies. “Some point to the Internet and immediately see doom and gloom,” he said. “But I don't think they understand that it is an incredibly important way, particularly for younger communities, to gather information today. By censoring that information, or heavily regulating that information, we could end up shortchanging or jeopardizing the value and potential of this medium.” But Furberg said that online commercial recruitment is part of a larger trend of drug companies looking for “quick and cheap” answers, which includes pharmaceutical firms or their contractors recruiting patients or conducting trials in countries where standards may be lower. “The system we’ve built up over decades works well,” Furberg said. “But it is costly and very often recruitment is a problem, particularly if you have trials of questionable ethical standards.”

Hampton, Tracy

doi: 10.1001/jama.299.23.2735pmid: 18559994

Part of a recommendation that children with attention-deficit/hyperactivity disorder (ADHD) receive heart evaluations before treatment with stimulant drugs is drawing criticism from some experts who say the advice is premature. The guidance, provided in a statement recently published by the American Heart Association (AHA), appeared to suggest adding an electrocardiogram (ECG) to pretreatment evaluations of a child with ADHD and consulting with a cardiologist if an abnormal reading is generated (Vetter VL et al. Circulation. 2008;117[18]:2407-2423). Although cardiac risks have been associated with medications used to treat ADHD, some experts question the need at this time for an official AHA statement on the issue. (Photo credit: Andrei Malov/iStockphoto.com) The American Heart Association recommends assessing children for heart conditions before prescribing stimulant medications for attention-deficit/hyperactivity disorder. “The amount of evidence that exists to compel this recommendation is viewed by many, many people as simply being insufficient,” said Michael Ackerman, MD, PhD, professor of medicine, pediatrics, and pharmacology at the Mayo Clinic in Rochester, Minn. “We need to be studying this issue, but to have this catapulted to an AHA-endorsed recommendation seems to be a bit premature.” In the wake of such criticism, the AHA has responded with a clarification of the statement, which is endorsed by the American Academy of Child and Adolescent Psychiatry, the American College of Cardiology, Children and Adults with Attention-Deficit/Hyperactivity Disorder, and the National Initiative for Children's Healthcare Quality (http://circ.ahajournals.org/cgi/content/full/CIRCULATIONAHA.107.189473/DC1). Rose Marie Robertson, MD, the chief science officer of the AHA, noted that the statement's language may have obfuscated its meaning. “It is reasonable, but not mandatory, for a patient's physician to obtain an ECG if she or he feels it is warranted,” she explained. After reviewing the scientific literature on stimulant drugs and cardiac death in children and analyzing information from the US Food and Drug Administration's Advisory Committee meetings, the authors—the AHA's Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee and the Council on Cardiovascular Nursing—concluded that ADHD may be more prevalent in children with heart disease than in the general pediatric population. Also, an FDA review revealed reports of sudden death in patients with underlying serious heart problems or defects who were taking ADHD medications. The FDA has advised that all patients being considered for treatment with ADHD medications be carefully evaluated for cardiovascular problems. This has caused some reluctance among parents and physicians to provide the medications to children with any form of heart condition. “We ought to be looking into it, but the drugs have a very, very low sudden death rate of approximately 3 per year,” said Ackerman. (Approximately 2.5 million children took medications for ADHD in 2003 according to the Centers for Disease Control and Prevention.) Indeed, the authors of the AHA statement noted that it is not clear that these medications directly increase a child's risk of sudden cardiac death. The AHA recommendations note that if heart problems are suspected after an evaluation that includes an ECG, stimulant treatment is not necessarily counterindicated. If a pediatric cardiologist agrees that ADHD medication can be initiated, periodic monitoring is advised, with a blood pressure check within 1 to 3 months, then again at routine follow-ups every 6 to 12 months, the statement said. Ackerman is skeptical that these steps will be worth it. “This is a $250 million recommendation just to get one ECG for each of the patients who are currently being treated with medication for ADHD,” he said. There also “will be a ripple effect on cardiology evaluations that will be necessary because of things that will be flagged on these ECGs,” he added. Ackerman also noted that ECG screenings can be difficult to accurately perform and interpret. Robertson conceded that “in some cases of cardiovascular disease, abnormal patterns are clear-cut; in others, only a reader experienced with pediatric ECGs would be likely to define the abnormality.” All experts agree that more studies are needed to assess the true risk of cardiovascular adverse effects of stimulant drugs in individuals with and without heart disease. The authors of the AHA statement propose generating a registry for gathering data on a larger, organized scale. They also suggest that randomized, double-blind, placebo-controlled trials should be considered.

Kuehn, Bridget M.

doi: 10.1001/jama.299.23.2736pmid: 18559995

Chicago—Counseling and certain combinations of behavioral therapies, drug therapies, or both may increase smokers' chances of quitting, according to an updated guideline for tobacco cessation treatment published by the US Public Health Service in May (http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf). The guideline, an update of previous versions published in 1996 and 2000, is based on a review of more than 8700 studies and reflects recent advances in cessation treatment and a greater understanding of what types of interventions are most effective. A consortium of 8 organizations—the Agency for Healthcare Research and Quality; the Centers for Disease Control and Prevention; the National Cancer Institute; the National Heart, Lung, and Blood Institute; the National Institute on Drug Abuse; the Robert Wood Johnson Foundation; the American Legacy Foundation; and the Center for Tobacco Research and Intervention at the University of Wisconsin School of Medicine and Public Health—provided funding and oversight. (Photo credit: AJPhoto/www.sciencesource.com) Clinicians should advise patients trying to quit smoking that nicotine replacement and other smoking cessation therapies may help. Carlos Roberto Jaén, MD, PhD, vice chair of the panel that completed the guideline update, noted how far therapies for cessation have come since the 1980s. Physicians today have many choices of medications and counseling backed by the highest quality of evidence, he noted. According to the guideline, cessation counseling provided individually, in a group, or over the telephone is an effective intervention and its effectiveness increases with greater intensity. Such counseling is now widely available; every state has a tobacco “quit line,” which can be reached by dialing 1-800-QUITNOW. There also are now 7 cessation medications approved by the US Food and Drug Administration (FDA)—bupropion SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, nicotine patch, and varenicline. However, in February, the FDA warned of reports of depression, suicide, suicide ideation, agitation, and other behavioral changes occurring in some patients using varenicline. In light of these warnings, the guideline suggests physicians ask patients about mental health issues prior to treatment. Two weeks after the guidelines were released, the Institute for Safe Medication Practices, a non-profit organization based in Horsham, Pa, released a report detailing other patterns of serious events reported to the FDA including accidents, vision disturbances, heart rhythm disturbances, movement disorders, moderate to severe skin reactions, and possible loss of glycemic control (www.ismp.org/docs/vareniclineStudy.asp). Clinicians should routinely ask about tobacco use and offer cessation therapies, according to the guideline. Additionally, the guideline emphasizes that a brief intervention by a clinician may boost the odds of a patient quitting tobacco use, even those patients who are not yet willing to quit. The evidence base for tobacco cessation treatments has increased considerably since the previous editions of the guideline, noted Sue Curry, PhD, president-elect of the Society for Research on Nicotine and Tobacco. Combining counseling and medication increases a patient's chances of quitting more than either alone, according to the guideline, and clinicians should encourage all patients who wish to quit to use both medication (unless contraindicated) and counseling. Physicians also are urged to consider using medication combinations with proven effectiveness, such as long-term use of the nicotine patch with nicotine gum or spray, the patch plus a nicotine inhaler, or the patch plus bupropion SR. A new feature of the updated guideline is information about the comparative effectiveness of cessation medications. A meta-analysis comparing various medications with the nicotine patch suggests that 2 mg of varenicline daily or combining long-term use of the patch with nicotine replacement gum or spray as needed improves a patient's chances of achieving long-term abstinence. Selective serotonin reuptake inhibitors or naltrexone were less likely to result in long-term abstinence than the patch alone. Another advance is the availability of data on cessation therapies for adolescents. Curry noted that in 1996 there was little evidence supporting interventions for adolescents, and in 2000 there was just one review of the literature on the subject. The current guideline drew from 2 meta-analyses that indicate counseling is an effective therapy for adolescents, although the data are still not sufficient to determine whether adolescents may benefit from cessation medications.

Stephenson, Joan

doi: 10.1001/jama.299.23.2737-dpmid: N/A

The European Commission approved the first prepandemic avian influenza vaccine for use in the European Union, according to an announcement last month by the vaccine's manufacturer, GlaxoSmithKline. A prepandemic vaccine is produced in advance of a pandemic (based on the avian H5N1 strains circulating at that time) to provide health authorities with the potential to protect the population before or at the onset of an outbreak. In contrast, a conventional pandemic vaccine is based on the specific pandemic influenza strain, but because it takes 4 to 6 months to produce, it is not likely to be available to many individuals who become ill early in the pandemic. The company said it had signed contracts for the vaccine with the United States and several European countries and that it would donate 50 million doses to the World Health Organization to help establish a stockpile of prepandemic vaccines that the agency could distribute to poor countries.

Stephenson, Joan

doi: 10.1001/jama.299.23.2737-apmid: N/A

Chronic conditions such as heart disease and stroke have overtaken infectious diseases as the leading causes of death globally and will cause more than three-quarters of all deaths by 2030, according to a new report released in May by the World Health Organization (http://www.who.int /entity/whosis/whostat/EN_WHS08_Full.pdf). Projections suggest a massive shift in the distribution of deaths over the next 25 years, according to the report, World Health Statistics 2008. Between 2004 and 2030, deaths from cardiovascular disease will increase from 17.1 million to 23.4 million and deaths from cancer will increase from 7.4 million to 11.8 million. The report also highlights other important issues, including tobacco's role as a risk factor for most of the leading causes of death, the soaring cost of health care worldwide, and the huge disparity between maternal mortality rates in rich and poor nations.

Stephenson, Joan

doi: 10.1001/jama.299.23.2737-bpmid: N/A

Some carbon “nanotubes”—a key nanotechnology product—may behave like asbestos fibers and pose a health threat, according to new research in mice (Poland CA et al. Nat Nanotechnology. 10.1038/nnano.2008.111 [published online ahead of print May 20, 2008]). Nanotubes, minuscule cylinders only a few billionths of a meter in diameter, are under study for applications in medicine, electronics, and other areas. But some scientists have raised concerns about potential health risks of some nanotubes that have a needlelike shape similar to that of asbestos fibers. To study this possibility, researchers in Scotland and the United States injected long multiwalled carbon nanotubes into the abdominal cavity of mice. The animals developed inflammation and precancerous growths—granulomas—effects similar to those provoked by asbestos fibers. The finding is important “because research and business communities continue to invest heavily in carbon nanotubes for a wide range of products under the assumption that they are no more hazardous than graphite,” the researchers noted. “Our results suggest the need for further research and great caution before introducing such products into the market if long-term harm is to be avoided.” (Photo credit: Craig A. Poland/University of Edinburgh) A new study in mice raises concerns that long multiwalled “nanotubes” may pose health risks similar to those posed by asbestos.