JAMA

doi: 10.1001/jama.2015.14305pmid: N/A

Research Aspirin and the Development of ARDS in At-Risk Patients Management of acute respiratory distress syndrome (ARDS) is primarily supportive. Whether early intervention can prevent the development of ARDS is not known. In a multicenter randomized placebo-controlled trial that enrolled 400 patients who presented to the emergency department and were assessed to be at risk of developing ARDS, Kor and colleagues evaluated the efficacy and safety of early aspirin administration for prevention of ARDS. The authors found that compared with placebo, use of aspirin—a 325-mg loading dose followed by 81 mg/d through hospital day 7—did not reduce the risk of ARDS at 7 days. An Editorial by Reilly and Christie discusses prevention of ARDS. Editorial Continuing Medical Education Opioids and Mortality in Patients With Chronic Noncancer Pain In a retrospective study of Tennessee Medicaid data representing 22 912 new episodes of prescribed therapy for patients with chronic noncancer pain and no evidence of end-of-life care, Ray and colleagues assessed the relative risk of death among patients who initiated therapy with long-acting opioids compared with analgesic anticonvulsants or low-dose cyclic antidepressants prescribed for pain. The authors found that prescription of long-acting opioids was associated with a significantly increased risk of all-cause mortality, including deaths from causes other than overdose. Comparative Weight Loss With Pharmacologic Treatment Data on the comparative effectiveness of 5 medications approved for management of obesity are limited. In a network meta-analysis of data from 28 randomized trials (29 018 total patients) comparing orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate or liraglutide with either another active agent or placebo to treat overweight or obesity in adults, Khera and colleagues found that compared with placebo, the medications were each associated with higher odds of achieving a 5% or greater weight loss at 1 year. Phentermine-topiramate and liraglutide were associated with the greatest weight loss. Ventilation Delivered by Helmet vs Face Mask in ARDS Noninvasive ventilation (NIV) with a face mask is relatively ineffective for preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). In a randomized trial that enrolled 83 patients with ARDS and NIV with a face mask for at least 8 hours, Patel and colleagues found that compared with continued NIV delivered by face mask, switching to NIV delivered with a helmet resulted in a significant reduction in intubation rates and 90-day mortality. In an Editorial, Beitler and colleagues discuss NIV in early ARDS. Editorial Continuing Medical Education Clinical Review & Education Polymyalgia Rheumatica and Giant Cell Arteritis This systematic review by Buttgereit and colleagues summarizes the evidence relating to the diagnosis and treatment of polymyalgia rheumatica and giant-cell arteritis. Twenty randomized trials of therapies (1016 patients) and 30 imaging studies for diagnosis or assessment of treatment response (2080 patients) were included. Characteristic clinical features, findings on imaging studies, and consensus-based recommendations for pharmacotherapy are presented. Continuing Medical Education Avoiding Opioid Analgesics in Chronic Low Back Pain Authors of a systematic review and meta-analysis published in JAMA Internal Medicine reported that recommended doses of opioid analgesics did not provide clinically meaningful pain relief in persons with chronic low back pain. In this From The JAMA Network article, Ballantyne discusses avoiding opioid treatment in the absence of evidence for effectiveness. From The Medical Letter: Treatment of Lyme Disease This Medical Letter on Drugs and Therapeutics article summarizes recommendations for treatment of Lyme disease. After an Ixodes scapularis or I pacificus tick bite, prophylaxis with a single dose of doxycycline can be considered for nonpregnant adults and children aged 8 years and older. Antibiotics (doxycycline or recommended alternatives) cure almost all patients with erythema migrans and prevent more severe manifestations of Lyme disease.

doi: 10.1001/jama.2015.14306pmid: N/A

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Butt, Carrie A.

doi: 10.1001/jama.2015.14307pmid: 27299606

When does the convergence of color, shape, line, and texture become more than the simple means to record a scene? How do they combine to produce a feeling, or an emotion? At what point does art cross the threshold from picture to idea? These were questions facing the painter Émile Bernard (1868-1941) and many of his contemporaries at the end of the 19th century. At least according to one critic, Adolphe Retté, writing in the magazine L’Ermitage, Bernard had provided some answers: “Paint for us landscapes which are symbols, portraits which are thoughts—in other words pictures where lines and tones represent an idea; you [Bernard] have what it takes to do that.” Émile Bernard (1868-1941), Still-Life With Orange, 1887, French. Oil on board, mounted on canvas. 31.8 × 41 cm. Courtesy of the High Museum of Art (http://www.high.org/), Atlanta, Georgia; purchase, 2000.209. © 2016 Artists Rights Society (ARS), New York, New York/ADAGP, Paris. Bernard was born into the comfort of a bourgeois home in Lille, France, in 1868. His father worked in the textile trade and relocated the family to Paris when Bernard was about 10 years old. According to an unpublished autobiography, Bernard felt rejected by his family at a young age. It did not help that his parents lavished the majority of their affection on a sickly younger sister. The decision to become an artist was not one with which his parents agreed, and consequently their relationship was filled with strife. Nonetheless, in 1884 at the age of 16, Bernard was accepted as a pupil into the Paris studio of artist Fernand Cormon. The connections made in Cormon’s studio were formative, both personally and professionally. It was here that he met other young avant-garde artists like Henri de Toulouse-Lautrec and Vincent van Gogh, who were like-minded in their interest of exploring new styles of art. They felt the dominant styles of Impressionism and Neoimpressionism were too technical, too scientific, and too dependent on the objective eye of the painter. Art, they felt, should serve a higher purpose other than the simple recording of everyday life. It needed to express the emotion of the artist and affect its viewers on a higher spiritual plane. Perhaps it was fortuitous that in 1886, Bernard was expelled from Cormon’s studio for insubordinate behavior. He subsequently spent six months traveling throughout Brittany and Normandy searching for suitable subjects that would help to synthesize his quest of capturing the spiritual through art. The regional art, architecture, and unique cultural customs of the area helped him to define new styles like Cloisonnism. Developed with his travel companion and artist Louis Anquetin, Cloisonnism was characterized by flat, bold planes of color outlined with thick black lines. Informed by stained glass and popular Japanese ukiyo-e prints, the style was incorporated into works by many contemporary artists. While Cloisonnism was a new style, it did not have the intellectual rigor of an art movement per se. To pair theory with style, Bernard worked with Paul Gauguin, whom he met in Pont-Aven in Brittany in 1888. Gauguin had moved to the region to try to answer some of the same questions that were nagging Bernard. Together they explored similar themes in their work, attempting to correlate emotion and subjectivity with formal means like line, color, and shape. Through these investigations they defined what would come to be known as Symbolism. Symbolism had predecessors in literature and other visual artists who focused on trying to reflect the worlds of dreams and myths. But the version of Symbolism conceived by Gauguin and Bernard took its cues from the more simple lives of peasants in the south of France. Their chosen subjects were primarily rural life, religious scenes, and landscapes, which were rendered with abstract patches of unmodulated color and no perspective. We see tenets of Symbolism expressed in Still-Life With Orange. Here perspective is dispensed in favor of color as a humble still-life is flattened and posed against a winter-green surface and a thinner band of navy blue horizon. While the orange is brightly rendered, the other objects are cast with muted tones of greens, violets, blues, and peaches. The outlines of the objects are all softly blurred, or smudged, unmooring them just slightly from the foundation of the table on which they sit. The combination of colors and indistinct forms lends the image an ethereal quality. This unreality also plays out through the indistinct identity of the items on display. Are the objects in front of the orange a pear, a lemon, a plum, or a potato? Is the item on the right, pushed to the front of the picture plane, a carrot, a radish, or a turnip? Does the pitcher behind it deliver wine, or water, or does it hold a bouquet of freshly cut flowers? Bernard would tell us that these particularities do not matter because the composition is ultimately a feeling portrayed or an emotion felt. While their time working together in Pont-Aven was fruitful, a rift in Bernard and Gauguin’s friendship was created when art critic Albert Aurier wrote an article on the development of Symbolism in which Gauguin was given more prominence. It was a slight that dissolved the friendship. After Pont-Aven, Bernard devoted much of his time to writing, publishing several articles and reviews in various art publications. In 1893 he left for a ten-year sojourn in Egypt with brief visits to Spain and Venice. His art went through a conversion as he abandoned Symbolism for a highly detailed, High Renaissance style of art. He also became entrenched in Catholicism, and his politics became strictly conservative. It was a shift that both surprised and concerned his progressive friends. Despite this turn, Bernard holds an important, although unheralded, place in the history of art. Symbolism freed artists from the burden of painting exactly what they saw. Instead they could attempt to bridge the gaps between form and idea and between color and emotion, thereby creating more complex connections between art and the natural world. There are complements to this lesson in Still-Life With Orange, as each color finds a corollary in one or more of the items displayed. The same peaches and violets that render the fruits are picked up in the pitcher. Even the distinctive orange finds connecting flecks around the pitcher’s handle and the curlicue root of the vegetable.Things, it seems, are not distinct but always interrelated, no matter the forms in which they come. We are all colored by our connections, and this realization brings us closer to the human condition.

Jacob, Julie A.

doi: 10.1001/jama.2016.4875pmid: 27203730

Try nonpharmacologic and nonopioid therapies first, the Centers for Disease Control and Prevention (CDC) recommended in a recently published opioid prescribing guideline for primary care clinicians in outpatient settings (Dowell D et al. JAMA. 2016;315[15]:1624-1645). The CDC’s call for nonpharmacologic approaches may serve to heighten clinician interest in nonpharmacologic strategies for managing chronic pain, such as mindfulness-based stress reduction (MBSR), commented Steven Stanos, DO, medical director for the Swedish Pain Services at Swedish Medical Center in Seattle, and president-elect of the American Academy of Pain Medicine. ©iStock.com/webphotographeer “Hopefully, the [CDC guideline] will be a good push to get physicians to start thinking about [behavioral-based pain management therapies] in primary care,” Stanos said. In mindfulness meditation, a person is taught to become aware of his or her breathing, thoughts, and physical sensations in the present moment and view them without judgment (Tang YY and Leve LD. Transl Behav Med. 2016;6[1]:63-72). Limited research indicates that mindfulness meditation for pain management therapy has promise (Lee C et al. Pain Med. 2014;15:S21-39). However, pain management researchers note that research gaps need to be filled and better ways of referring patients to mindfulness meditation programs established before physicians can add the therapy to clinical practice. “Learning for who and how [mindfulness] can work is at the very early stage,” said Josephine Briggs, MD, director of the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH). Efficacy of Mindfulness Recently, 2 large randomized trials showed that mindfulness meditation can help reduce chronic low back pain. Researchers at the Group Health Research Institute in Seattle randomized 342 adults with chronic lower back pain into 3 groups: 1 participated in 8 weekly 2-hour MBSR sessions that included meditation and yoga, another took part in 8 weekly 2-hour sessions using cognitive behavioral therapy (CBT) training to teach participants how to change their thoughts about pain, and a third was a usual care group (Cherkin DC et al. JAMA. 2016;315[12]:1240-1249). The MBSR and CBT groups also continued with their usual medical care, and participants received materials and instructions to practice between sessions. After 26 weeks, 43.6% of adults in the MBSR group had experienced clinically meaningful reduction in pain compared with 44.9% in the CBT group and 26.6% who received only usual care, which included anti-inflammatory medications, opioids, or physical therapy. Another study involving 282 older adults at the University of Pittsburgh School of Medicine showed that mindfulness meditation could help reduce chronic low back pain. The intervention group was offered 8 weekly mindfulness meditation sessions, followed by 6 monthly sessions. At the 6-month mark, 44.4% of the intervention group experienced at least a 30% decrease in their current chronic low back pain compared with 25.2% of the control group (Morone NE et al. JAMA Intern Med. 2016;176[3]:329-337). Such studies highlight how mind-body therapies like mindfulness meditation can be used to shift chronic pain treatment from a “biomedical disease model” to a “patient-centered” model focused on “patient engagement in daily self-management,” a recent JAMA editorial noted (Goyal M and Haythornthwaite J. JAMA. 2016;315[12]:1236-1237). These studies and others also illustrate that pain is a complex phenomenon involving more than a direct nerve impulse from the affected tissue or limb to the somatic sensory cortex, Briggs explained. A person’s thoughts and emotions also play a role in pain perception, she said. “That’s one of the reasons why there is growing recognition that learning strategies to diffuse or reduce the emotions associated with pain and the fear associated with pain may help give people a better sense of control [over their pain],” Briggs said. Mindfulness meditation helps calm the fear that pain awakens, said Eric Schoomaker, MD, PhD, professor and vice chair for leadership, programs, and centers in the department of military and emergency medicine, Uniformed Services University of the Health Sciences in Bethesda, Maryland. Schoomaker also serves on the NCCIH advisory council. “We catastrophize pain,” Schoomaker said. He explained that patients construct their own narratives of why they are in pain, how the pain felt in the past, and how it might feel in the future. Those thoughts can exacerbate sensations of pain, he noted. Mindfulness meditation helps patients, he added, by teaching patients how to observe their thoughts about pain without judgment or emotion. Mapping the Brain’s Response to Mindfulness Researchers are also trying to understand the neural mechanisms underlying mindfulness meditation’s pain-relieving effects. Such information can help determine how mindfulness meditation might be combined with other pain-reducing therapies, as well as provide researchers with information that will help them develop new therapies. For example, in a study at Wake Forest Baptist Medical Center’s Center for Integrative Medicine, researchers studied functional magnetic resonance images of volunteers engaged in mindfulness meditation or an active control task in the presence of a noxious stimuli. The practice of mindfulness meditation in the presence of noxious stimulation—a thermal probe placed against the leg of each volunteer—reduced self-reported ratings of how unpleasant the pain felt by 57% and pain intensity ratings by 40% compared with rest (in the absence of behavioral intervention). Attention to breath alone, the active control condition, did not affect intensity or unpleasantness of pain. The imaging revealed greater activation of the orbitofrontal cortex (OFC) during meditation relative to attentional control and that this activity was associated with meditation-induced reduction in the unpleasantness of pain (Zeidan F et al. J Neurosci. 2011;31[14]:5540-5548). The OFC controls how people put into context what they sense in the environment, explained Fadel Zeidan, PhD, associate director of neuroscience at Wake Forest Baptist Medical Center’s Center for Integrative Medicine. “The subjects said, ‘I felt the pain was there, but I was able to let it go. I didn’t dwell on it so much,’” Zeidan explained. What’s more, mindfulness meditation deactivated the thalamus, which serves as a gateway between the spinal cord and the brain, and was associated with reduced pain unpleasantness, Zeidan explained. The investigators determined that meditation-induced reduction of pain intensity was associated with activation of the anterior cingulate cortex (ACC) governing cognitive control and emotional regulation. Because the OFC and ACC contain numerous opioid receptors, Zeidan’s team conducted a second study to determine whether opioids would block the pain-reducing effect of mindfulness meditation. They discovered, however, that the opioid antagonist naloxone did not counteract the pain-reducing effect of mindfulness meditation, suggesting the pain-relieving effects of meditation are not mediated by opioid receptor–dependent neural processes (Zeidan F et al. J Neurosci. 2016;36[11]:3391-3397). “We thought the naloxone would reverse the meditation effects,” Zeidan said. The fact that it didn’t, he added, “suggests that we can use opiates and nonopiate medications in addition to meditation to compound the pain-relieving effects.” The next step needed in the research, he explained, is to identify the neurotransmitters and receptors that trigger the pain-reducing effects of mindfulness meditation. Studies need to be conducted to determine who would benefit most from mindfulness practices and the optimal time and methods for such practices to reduce pain, Zeidan said. Additional research also is needed to compare mindfulness-based techniques like meditation directly with opioid and nonopioid medications, Briggs added. “It is a very interesting lack in our research portfolio,” Briggs said. “People propose meditation compared to a [patient health] education control, but not this direct head-to-head comparison or even a study to see if the availability of mindfulness training results in reduced opioid use.” Schoomaker said researchers and clinicians need to broaden the end point for pain relief studies beyond a numeric scale to holistically evaluate how the therapy improves the patient’s overall quality of life. Integration and Adoption If the collective evidence becomes solid enough for clinicians to add mindfulness to their toolbox of pain management therapies, they’ll need education about how to use the treatments and refer patients to behavioral health specialists or training classes. “The struggle is that physicians are not used to incorporating behavioral health into [pain management],” Stanos said. The weight of the CDC guideline will make it easier for physicians to discuss nonpharmacologic pain management approaches with patients, noted Nitin S. Damle, MD, an internist in Wakefield, Rhode Island, and president-elect of the American College of Physicians. While recent studies have produced promising clinical results, the logistical challenge lies in referring patients to mind-body programs. “There is not a lot of coordination between these services and traditional internal medicine, and so it is difficult to get the proper referrals done,” Damle said. That can be especially challenging in rural areas, he added, which may lack health care professionals trained in such techniques. One way to make mindfulness meditation and other mind-body therapies more easily available is to incorporate them into hospital- or clinic-based pain management programs. The pain service program at Swedish Medical Center, for example, folds mindfulness meditation and CBT directly into pain management programs, Stanos noted. Trained experts—physical therapists and psychologists—are on staff to show patients how mindfulness meditation may help ease their pain. Despite the limited evidence to date, Briggs suggested that physicians may want to consider mindfulness meditation as part of their pain management approach. “The relative low risk [of adverse events] makes it not inappropriate to recommend mindfulness practice to patients as a supplement to other ongoing strategies to control chronic pain,” Briggs said. Box Section Ref ID CDC Stresses Conservative Approach in Opioid Prescribing Guidelines In response to growing concerns about opioid medication abuse and increases in related deaths, the Centers for Disease Control and Prevention (CDC) in early 2016 issued an opioid prescribing guideline for primary care physicians in outpatient settings (Dowell D et al. JAMA. 2016;315[15]:1624-1645). The key recommendations for primary care physicians treating patients for pain not due to cancer or end-of-life conditions include the following: Nonpharmacologic and nonopioid pharmacologic pain management therapies are preferred for chronic pain management. Opioids should be used only if expected benefits in pain reduction and improved functioning outweigh the risks. Opioids should be continued only if clinically significant benefits are achieved that outweigh the risks. Physicians should establish treatment goals with patients and discuss with them the risks and benefits of opioid medication. Clinicians should prescribe the lowest effective dose and assess risks and benefits before prescribing doses of 50 morphine milligram equivalents or more per day. The lowest dose possible of immediate-release opioids should be prescribed for acute pain, generally for 3 days or less. Physicians should obtain a drug urine test from patients and review their history of prescription opioid use before prescribing opioids. Opioids and benzodiazepines should not be prescribed concurrently.

Frakt, Austin B.

doi: 10.1001/jama.2016.6790pmid: 27299607

The Medicare Advantage program, which offers private plan alternatives to traditional Medicare, is surging in popularity among Medicare beneficiaries (http://nyti.ms/1rGB0gu). More than 30% of about 55 million beneficiaries are enrolled in a Medicare Advantage plan, up from 16% a decade ago (http://kaiserf.am/1IniNZU). Yet among policy experts it remains as controversial as ever. At issue: do Medicare Advantage plans cost more or less than traditional Medicare? Austin B. Frakt, PhD Doug Levy You’d think a simple accounting exercise would settle the matter, but it’s a more complex question than it appears. What’s Being Covered? And Who Pays? Consider the consumer’s point of view. A typical Medicare beneficiary can choose from more than a dozen plans (http://nyti.ms/1W9tNpi). Nearly all provide more generous coverage than traditional Medicare, with lower cost sharing and coverage of additional items like hearing aids and eyeglasses. Moreover, many do so without requiring any additional premium from enrollees (http://bit.ly/1roYCIZ). Therefore, to Medicare beneficiaries, Medicare Advantage is cheaper than traditional Medicare because they get more for less. Now consider the plans’ point of view. Each plan discloses how much it would cost to cover exactly the same benefits as traditional Medicare for a Medicare beneficiary of average health. These estimates are used to establish how much plans are paid by the Medicare program and how much plans must charge in premiums. (One major benefit is not held constant in this exercise: most Medicare Advantage plans offer coverage only for a restricted network of physicians and hospitals. Traditional Medicare imposes no such restrictions.) The commission that advises Congress on Medicare payment policy analyzes these plan cost estimates, plan premiums, and Medicare’s payments to plans (http://1.usa.gov/23pITpc). In 2015, just as in previous years, it estimated that Medicare Advantage costs were less than the costs of traditional Medicare coverage. On average, in 2015 a Medicare Advantage plan provides Medicare services 6% more cheaply than traditional Medicare, though this figure varies across types of plans and markets. Here again, one could make the case that Medicare Advantage is cheaper than traditional Medicare, at least for provision of the same set of benefits. But what about taxpayers? Here the story has a couple of twists. Somebody is paying for the additional benefits Medicare Advantage plans provide. Even though Medicare Advantage plans may provide the Medicare benefit more cheaply than traditional Medicare, by law the Medicare program pays the plans much more. Through a complex formula that includes quality incentives and other factors, in 2015, an average Medicare Advantage plan was paid 8.5% more than its costs and 2% more than traditional Medicare. This figure has been much higher in the past; in 2009 plan payments were 14% higher than traditional Medicare’s cost (http://1.usa.gov/1NWGzEp). “Up Coding” and Health Care Utilization But Medicare Advantage plans likely cost taxpayers even more than government figures suggest. Several recent investigations(http://n.pr/1IYRvbu) and studies show that plans find ways to make their enrollees appear sicker than they would be if enrolled in traditional Medicare, a phenomenon known as “up coding.” Because Medicare pays plans higher rates for sicker enrollees, up coding increases government payments to plans. A government audit found such up coding to be very common (http://n.pr/1SN2IoT). Last year, an investigation by the Center for Public Integrity found that it accounted for nearly $70 billion in additional payments to Medicare Advantage plans from 2008 through 2013 (http://bit.ly/1l4hmTg). Analysis by Michael Geruso, PhD, a health economist at the University of Texas, and Timothy Layton, PhD, a postdoctoral research fellow at the Harvard Medical School, quantified the cost of Medicare Advantage up coding (http://bit.ly/1WJ1Kva). It increases it by 6.4%, although an adjustment by Medicare reduces the effect to just more than 1% (http://bit.ly/1SN3n9W). But there’s one more twist in the story: Several studies(http://bit.ly/1Nk2xRF), including, most recently, one by Katherine Baicker, PhD, and Jacob Robbins, (http://bit.ly/23pLa3P), have found that additional enrollment in Medicare Advantage plans reduce health care utilization not just for those additional enrollees but also for the remaining traditional Medicare enrollees. In other words, the influence of managed care on practice patterns spills over into the traditional program (http://bit.ly/1QSijh6). And this could save taxpayers money, offsetting the additional cost of Medicare Advantage. To date, nobody has estimated the full effect of Medicare Advantage spillovers, so it is not clear if taxpayers come out ahead or not. So which costs more, Medicare Advantage or traditional Medicare? Enrollees and plans both benefit from lower costs. Whether taxpayers do is not yet settled. Back to top Article Information Corresponding Author: Austin B. Frakt, PhD ([email protected]). Published online: May 4, 2016, at http://newsatjama.jama.com/category/the-jama-forum/. Disclaimer: Each entry in The JAMA Forum expresses the opinions of the author but does not necessarily reflect the views or opinions of JAMA, the editorial staff, or the American Medical Association. Additional Information: Information about The JAMA Forum is available at http://newsatjama.jama.com/about/. Information about disclosures of potential conflicts of interest may be found at http://newsatjama.jama.com/jama-forum-disclosures/.

Rubin, Rita

doi: 10.1001/jama.2016.7326pmid: N/A

People who work in health care facilities experience higher rates of nonfatal injuries due to violence in the workplace than workers overall, according to a recent Government Accountability Office (GAO) report, which called for new efforts to protect these workers (http://1.usa.gov/21qWGwh). Department of Labor (DOL) data show that in 2013, private-sector health care workers in hospitals and other inpatient facilities were at least 5 times more likely than private-sector workers in general to need to take days off from work because of violence-related injuries, according to the GAO report. Health care workers interviewed for the GAO report described a variety of workplace violence incidents involving patients, such as incurring a broken hand after intervening in a fight between 2 patients at a psychiatric hospital. The GAO recommended that the DOL’s Occupational Safety and Health Administration (OSHA) assist inspectors in citing employers for hazards, including violence in health care facilities, identified during inspections. OSHA also should follow up on hazard alert letters, sent when the criteria for a citation are not met. In addition, OSHA should assess its current efforts to curb workplace violence in health care facilities. “No worker should ever have to fear facing violence on the job,” Sen Patty Murray (D, Washington) said in a statement (http://1.usa.gov/1Z4euvi).

Rubin, Rita

doi: 10.1001/jama.2016.7331pmid: N/A

A recent Government Accountability Office (GAO) review found wide variation in the length of time newly enrolled veterans had to wait to receive primary care from the Department of Veterans Affairs’ (VA) Veterans Health Administration (VHA), if they were even able to access care. In its review of 180 newly enrolled veterans, the GAO found that 60 patients had not been seen by a VA clinician at the time of the review because VA medical center staff had not scheduled appointments for them in accordance with VHA policy (http://1.usa.gov/26bjEew). The other 120 newly enrolled veterans in the review waited 22 days to 71 days from the time they asked the VA to contact them to schedule appointments to when they were seen by a health care practitioner, according to the GAO analysis. “These time frames were impacted by limited appointment availability and weaknesses in medical center scheduling practices, which contributed to unnecessary delays,” the GAO found. After the report was made public, Rep Mike Coffman (R, Colorado), chair of the Committee on Veterans’ Affairs’ Subcommittee on Oversight and Investigations, questioned VA officials about this ongoing problem. “Our veterans are not receiving the care they are owed, and no one is held accountable … and yet, the VA paid out more than $142 million in bonus money last year, ” Coffman said in a statement (http://1.usa.gov/1NiCw57).

Rubin, Rita

doi: 10.1001/jama.2016.6599pmid: N/A

Sudden price hikes of decades-old prescription drugs represent a market failure with far-reaching consequences, Sen Susan Collins (R, Maine), chair of the Senate Special Committee on Aging, said at a series of hearings on the subject (http://1.usa.gov/1rezDbf). Senate hearings investigate sudden price hikes on decades-old prescription drugs affecting patients, physicians, and hospitals. ©iStock.com/Juanmonino At the April hearing, retiree Berna Heyman described what happened when Valeant Pharmaceuticals bought the 2 main drugs for treating her Wilson disease, a potentially life-threatening genetic disorder in which the body cannot remove extra copper. Heyman said she took the drug Syprine for years, until Valeant acquired the drug and raised the price for a month’s supply from $652 to $21 267. Since she could no longer afford Syprine, Heyman said, she had to switch to an alternative, inferior treatment. “This kind of price manipulation and abuse of pricing has real consequences,” Collins said in her closing statement at the hearing, citing effects on physicians who must devote resources to helping patients secure the drugs and effects on hospitals that are trying to lower health care costs (http://1.usa.gov/23jzf7A). Collins, who has introduced bipartisan legislation to lower drug costs, called it “troubling” to see companies “locating monopoly drugs that are the gold standard for treatment of very serious conditions and then exploiting the system to raise the cost of these drugs to unconscionable levels despite the fact that [they] have not invested one dime in developing these drugs.”

Rubin, Rita

doi: 10.1001/jama.2016.7333pmid: N/A

Sen Edward Markey (D, Massachusetts) and Sen Chuck Grassley (R, Iowa) launched the Senate Cystic Fibrosis Caucus in April. About 30 000 US children and adults are living with the inherited lung disease, for which there is no cure. “The formation of this caucus is intended to highlight the importance of beating this dreadful, cruel disease and pledging to all those with cystic fibrosis and their loved ones that Congress is dedicated to supporting you,” Markey, who cofounded the House of Representatives Cystic Fibrosis Caucus in 2006, said in a statement (http://1.usa.gov/1pppW8I). “The advocacy of the cystic fibrosis community is impressive, and it’s gained results,” Grassley said in the statement. “The Senate caucus is meant to add to advocacy efforts in promoting awareness, research, and policies toward a good quality of life and a cure.”

doi: 10.1001/jama.2016.6975pmid: N/A

For the first time, promethazine—typically prescribed to treat nausea, vomiting, and motion sickness—has been found in counterfeit versions of the prescription opioid pain medication Norco, which normally contains acetaminophen and hydrocodone. Top, California Poison Control System/University of California, San Francisco The authors of recent case reports noted that promethazine use apparently has become common among chronic opioid users because it intensifies the opioid “high.” Their reports described 7 cases of opioid intoxication earlier this year in California’s San Francisco Bay Area from counterfeit Norco containing promethazine and fentanyl, a synthetic opioid analgesic with 100 times the potency of morphine (Vo TK et al. MMWR Morb Mortal Wkly Rep. 2016;65[16]:420-423). Among the cases was a couple who came to a Contra Costa County emergency department after taking what they believed to be Norco, illicitly purchased from a friend. The man, 36 years old, and woman, 30 years old, were each treated with a 0.4-mg dose of naloxone for symptoms of nausea, vomiting, central nervous system depression, and respiratory depression. Over the next 2 weeks, the San Francisco division of the California Poison Control System identified 5 additional cases of opioid intoxication from counterfeit Norco in the Bay Area. The 7 patients had serum fentanyl levels ranging from 1.6 to 10.1 ng/mL; all but 1 exceeded the therapeutic range for analgesia. Each patient’s serum specimens also contained promethazine. A counterfeit Norco tablet obtained from 1 patient contained 3.5 mg of fentanyl, 2.3 mg of promethazine, 39.2 mg of acetaminophen, and trace amounts of cocaine. All the Bay Area patients recovered; however, the authors stressed that illicit fentanyl added to medications is a growing and dangerous trend. Last year, 7 people in California took fentanyl-contaminated Xanax and 2 died. A previous outbreak of fentanyl abuse caused more than 1000 deaths during 2005 to 2007 (http://1.usa.gov/1Cw2Ker). Physicians should be suspicious of illegal fentanyl intoxication if a patient needs a large dose of naloxone to reverse acute opioid overdose symptoms, and all cases should be reported to local poison control centers and health departments, according to the authors. News From the Centers for Disease Control and Prevention Section Editor: Rebecca Voelker, MSJ.