LDL a Poor Marker of Heart Health in Patients with CKD

Among 836,060 adults with CKD who were followed for an average of 4 years, 7762 patients were hospitalized for heart attacks, most of whom had the lowest levels of kidney function at the start of the study. Despite their higher overall risk of having a heart attack, the link between higher LDL cholesterol and heart attack risk was weaker for these patients than for patients with higher kidney function. TheJASN findings suggest that criteria for treatments such as statins should not be based on LDL cholesterol levels in people with CKD, unlike in the general population.

Sugary Drinks Increase Kidney Stone Risk.

Sugary drinks were associated with a higher risk of kidney stone formation in a CJASN analysis of data on 194,095 individuals followed on average for more than 8 years. People who consumed one or more sugar-sweetened cola servings per day had a 23% higher risk of developing kidney stones than those consuming less than one serving per week. There was a 33% increased risk linked with sugar-sweetened non-cola. Several drinks were associated with lower risks: 26% for caffeinated coffee, 16% for decaffeinated coffee, 11% for tea, 31% to 33% for wine, 41% for beer, and 12% for orange juice.

Vitamin C Does Not Lower Uric Acid Levels in Patients with Gout.

Vitamin C does not reduce uric acid levels to a clinically significant degree in patients with established gout. Of 40 patients, 20 taking allopurinol (which inhibits uric acid production) were given 500 mg of vitamin C daily or increased doses of allopurinol, while another 20 patients were either started on allopurinol or vitamin C. Taking vitamin C for 8 weeks did not lower uric acid levels. The Arthritis & Rheumatism results differ from previous research that found that vitamin C reduced uric acid levels in healthy individuals who did not have gout but had elevated levels of uric acid.

Experts Describe New Thinking Regarding Organ Rejection.

Transplant researchers are challenging a long-held assumption about how biologic pathways trigger immune rejection of donor organs, noting that chemokines are not necessary to start the rejection response. Until now, scientists have thought that T cells were attracted to transplanted organs by chemokines that are secreted by epithelial cells of the organ when it becomes inflamed. Instead, they say that a donor kidney's antigen-presenting cells expose donor surface antigens to the recipient's immune system to trigger a response. The findings are published in the Journal of Clinical Investigation.

Researchers clone human embryonic stem cells.

Research on human embryonic stem cells generated extensive coverage in most of the nation's most widely circulated papers and online. However, while some sources characterized the research as a major advancement, others, like the Boston Globe, claimed it was "not a breakthrough." Meanwhile, some outlets touted the finding's potential to eventually benefit patients with certain health conditions, while others sources were more skeptical. Much of the coverage focused on the potential impact the research may have on the stem cell debate.

        In a front-page story, the Los Angeles Times (5/16, A1, Healy, 692K) reports, "For the first time, scientists have created human embryos that are genetic copies of living people and used them to make stem cells - a feat that paves the way for treating a range of diseases with personalized body tissues but also ignites fears of human cloning." Should the methods be "replicated in other labs," they "would allow researchers to fashion human embryonic stem cells that are custom-made for patients with Alzheimer's disease, diabetes and other" conditions.

        The New York Times (5/16, A17, Pollack, Subscription Publication, 1.68M) reports, "The researchers, at Oregon Health and Science University, took skin cells from a baby with a genetic disease and fused them with donated human eggs to create human embryos that were genetically identical to the 8-month-old." The scientists "then extracted stem cells from those embryos." This "embryo-creation technique is essentially the same as that used to create Dolly the sheep and the many cloned animals that have followed."

        The AP (5/16, Ritter) reports, "Shoukhrat Mitalipov of the Oregon Health & Science University, who led the research, said the success came not from a single technical innovation, but from revising a series of steps in the process." Mitalipov "noted it had taken six years to reach the goal after doing it with monkey embryos."

        Bloomberg News (5/16, Tirrell) reports, "The advance was enabled by a surprising ingredient, according to the report: caffeine gave the cells the boost they needed to remodel the donor DNA into embryonic cells."

        In an article titled "Experiment Brings Human Cloning One Step Closer," the Wall Street Journal (5/15, A2, Naik, Subscription Publication, 2.29M) points out, however, that the scientists were far from actually making a human clone.

        The NBC News (5/15, Fox) "Vitals" blog reports, "Lots of testing lies ahead and because of laws banning the use of federal money to directly make human embryos, Mitalipov's lab uses private funds instead." However, Mitalipov "believes the method cannot be used to make human babies."

        USA Today (5/15, A1, Vergano, 1.71M) reports on its front-page, "The real significance of the advance may be to re-ignite debate over human cloning, says bioethicist Insoo Hyun of Case Western Reserve University in Cleveland." According to the Food and Drug Administration's Curtis Allen, "Basically, FDA has jurisdiction over clinical research using cloning technology to create a human being." So far, according to Allen, the agency "has not licensed such a therapy."

        The US News & World Report (5/16, Koebler, 1.13M), however, reports that the new research "could help quiet the ethical debate surrounding stem cell research."

        Meanwhile, the Washington Post (5/16, Brown, 489K) points out that "few experts think that production of stem cells through cloning is likely to be medically useful soon, or possibly ever."

        The Boston Globe (5/16, Johnson, 250K) reports that the "paper, published in the journal Cell, is generating little excitement." While "it is a key technical advance," it is "not a breakthrough." Conversely, on its website, FOX News (5/15) calls it "a major medical breakthrough" with "major implications for the future of medical treatments."

Study Identifies Reasons Underlying Dialysis Decision-Making in the Elderly.

A French prospective study of 155 octogenarians and nonagenarians who were newly referred to nephrologists by general practitioners found that nephrologists' decision to initiate dialysis was based exclusively on uremic criteria. These included uncontrolled biological abnormalities, such as hyperkalemia or acidosis (71%), uncontrolled digestive disorders (35%), uncontrolled pulmonary or peripheral edema (29%), and uncontrolled malnutrition (12%). No patients with acute congestive heart failure or cancer initiated dialysis. The BMC Nephrology study noted predictors of premature death included acute congestive heart failure, age, any walking impairment, and hemoglobin levels under 10 g/dL.

Studies reveal high fat, sodium content in restaurant meals.

Bloomberg News (5/14, Wayne) reports that the "average meal at a chain restaurant contains more than half the calories, 1.5 times as much sodium and almost all the fat that people are recommended to consume in an entire day," according to a study published online May 13 in the journal JAMA Internal Medicine. The University of Toronto researchers "analyzed nutritional information for 685 meals and 156 desserts reported by 26 sit-down restaurant chains" and found that the meals contained an average of "1,128 calories, or 56 percent of the US Food and Drug Administration's 2,000 calorie-a-day recommendation."

        Reuters (5/14, Seaman) reports that in a separate study published online in the same issue of JAMA Internal Medicine, US Department of Agriculture Energy Metabolism Lab Director Dr. Susan Roberts, who is also a professor at Tufts University, and colleagues, analyzed the calories in 157 meals at small ethnic restaurants - American, Chinese, Italian, Japanese, Mexican and Thai - in the Boston metropolitan area and found that the meals contained an average of 1,327 calories, or 66 percent of the FDA's daily calorie-intake recommendation.

        AFP (5/14) notes that the "Italian meals had the highest average calories per meal (1,755), followed by American (1,494 calories) and Chinese (1,474 calories). Vietnamese meals had the fewest calories on average (922), and Japanese meals had the second lowest (1,027)."

        The New York Daily News (5/14, Miller, 543K) adds that the FDA is "working on legislation that will require chains with 20 or more locations to post calorie content for all of their menu items." But the Dr. Roberts, the lead study author of the Boston area study, said that only "accounts for about half the nation's restaurants. 'Fifty percent of restaurant locations are small places that don't post calories and aren't going to have to when the new legislation comes in,' she told the Daily News."

        The Boston Globe (5/14, Kotz, 250K) "Daily Dose" blog adds, "Other new research published in the same issue of JAMA Internal Medicine found that fast-food restaurants have done little to reduce their sodium content." A study by "researchers from the Centers for Science in the Public Interest, a nonprofit nutrition activist group, found that sodium increased in restaurant meals by nearly 3 percent from 2005 to 2011."

        The CBS News (5/14, Castillo) websites add that the CSPI study also "showed that the average sodium content in 402 packaged foods only decreased 3.5 percent between 2005 and 2011."

        MyHealthNewsDaily (5/14, Rettner) reports that in an editorial accompanying the CSPI study, "Dr. Mitchell Katz of the Journal of the American Medical Association noted that government regulation of salt content may be difficult. 'Regulating calorie size, or the maximum of a necessary nutrient, such as salt, will always raise questions of whether the government is going too far in regulating our lives,'" he noted.

        Additionally, the Huffington Post (5/13) points out that the "new studies come on the heels of a report (pdf) just published in the American Journal of Preventive Medicine, showing that the nutrition quality of fast food has improved just 3 percent over a 14-year period." Also covering the three JAMA Internal Medicine studies are HealthDay (5/14, Reinberg), MedPage Today (5/14, Petrochko) andHeartwire (5/14, O'Riordan).

New Cilia Research Could Have Implications for Kidney Disease.

The size limit for proteins to enter cells' cilia is much greater than previously thought, according to a Nature Chemical Biology study. The findings could have implications for kidney health because in the kidneys, cilia monitor the flow of urine, and defects in cilia are involved in polycystic kidney disease. Cilia translate mechanical or chemical forces into molecular signals for a cell so that it can respond to its environment. Previous research suggested that a fixed pore exists at the base of a cilium that allows only small molecules inside. Figuring out how cilia select their captives is still unknown.

Fish oil not associated with cardiovascular benefits

Patients with cardiovascular risk factors who took n-3 polyunsaturated fatty acids daily appeared to have no reduction in cardiovascular mortality or morbidity, according to a new study.

Researchers in Italy performed a double-blind, placebo-controlled clinical trial that randomly assigned general-practice patients with atherosclerotic vascular disease or more than one cardiovascular risk factor but no myocardial infarction to receive 1 g of n-3 fatty acids daily or olive oil as a placebo. The goal of the study was to determine the potential benefit of n-3 fatty acids in this patient subgroup.

The initial primary end point was cumulative death, nonfatal myocardial infarction and nonfatal stroke, but because of a lower-than-anticipated event rate, it was revised at one year to be time to death or hospital admission related to cardiovascular causes. Secondary end points included the initial primary end point; a composite of time to death from cardiovascular causes, nonfatal myocardial infarction or nonfatal stroke; death due to coronary heart disease; and sudden death due to cardiac causes. The results were published in the May 9 New England Journal of Medicine.

Overall, 12,513 patients cared for by 860 general practitioners were enrolled in the study, and 12,505 were included in the intention-to-treat analysis. A total of 61.5% of the patients were men, and the mean patient age was 64 years. In the intention-to-treat analysis, 6,239 patients received n-3 fatty acids and 6,266 received placebo. At a median follow-up of five years, 1,478 patients (11.8%) had experienced the primary end point, 733 in the n-3 fatty acids group and 745 in the placebo group (11.7% vs. 11.9%; adjusted hazard ratio with n-3 fatty acids, 0.97; 95% CI, 0.88 to 1.08; P=0.58). Rates of all of the secondary end points were also similar between groups.

The authors concluded that in this study population, n-3 fatty acids had no effect on cardiovascular morbidity and mortality. They noted that their results differ from those of previous trials, which found a benefit mainly from reducing sudden deaths related to cardiac causes. "It is conceivable that the effects of n-3 fatty acids become manifest primarily in patients who are particularly prone to ventricular arrhythmic events (e.g., those with a myocardial scar or left ventricular dysfunction)," the authors wrote. They noted that research into the safety profile of n-3 fatty acids in the latter population could be useful.

HLA-Mismatched Kidney Transplantation Possible without Maintenance Immunosuppression.

Researchers have expanded a trial that in 2008 found that four out of five patients with ESRD who received combined bone marrow and kidney transplants from HLA single-haplotype mismatched living related donors could discontinue all immunosuppressive therapy 9 to 14 months after transplantation and maintain stable renal function for 2 to 5 years. Results from a second group of five patients suggest that the current B-cell depletion regimen adequately controls the development of donor-specific antibodies but that additional modifications are needed to overcome engraftment syndrome. The findings are published in the New England Journal of Medicine.

Study Implicates Glutamate in Restless Legs Syndrome.

Imaging of individuals' brains while they slept revealed that people with restless legs syndrome have abnormally high levels of glutamate, a neurotransmitter involved in arousal. The more glutamate the researchers found in the brains of those with the condition, the worse their sleep. The Neurology study included 28 people with restless legs syndrome and 20 people without. Currently available drugs – such as the anticonvulsive gabapentin enacarbil – can reduce glutamate levels in the brain, but they have not been given as a first-line treatment for patients with restless legs syndrome.

Discovery may one day lead to new therapy for heart failure.

The CBS Evening News (5/9, story 3, 2:05, Pelley, 5.58M) reported that in a mouse study, researchers found a hormone that may be a "fountain of youth" for heart failure.

        USA Today (5/9, Vergano, 1.71M) reports that study author Richard Lee of Brigham and Women's Hospital in Boston, said, "We think this is something that we can really look at very carefully for the form of heart failure that occurs in the elderly."

        On its website, CBS News (5/10) reports that researchers "honed in on a hormone called GDF-11, which declines with age in mice."

        On its website, FOX News (5/10, Woerner) reports that investigators "injected GDF-11 into the blood streams of older mice in order to increase their GDF-11 levels to match the levels found in younger mice" After about one month, the investigators looked at "the hearts of the older mice, which had previously shown thickened walls similar to those in older humans." The investigators "found that the thickening had reversed, and the hearts of the older mice now looked almost identical to those of the younger mice."

        The Boston Globe (5/10, Johnson, 250K) reports that the scientists "hope that the discovery will lay a foundation for a new approach to therapy for a common form of heart failure that strikes elderly people, although much more research is needed before it could be tested in people."

Study: Herbal supplements often contain ED medication ingredients.

Reuters (5/10, Grens) reports that many herbal dietary supplements that purport to enhance men's sexual stamina actually contain the same active ingredients that are found in erectile dysfunction treatments such as Pfizer's Viagra (sildenafil), according to a studypublished online May 1 in the Journal of Sexual Medicine. Pfizer researcher Neil Campbell and colleagues analyzed 91 samples from 58 herbal supplements they purchased from small retail stores in Atlanta and Baltimore. They found that 81 percent of the supplements, with such names as Rize 2 The Occasion and Stiff 4 Hours, were labeled as containing all natural ingredients but actually contained sildenafil, tadalafil, which is marketed as Cialis, or a similar drug product not approved by the Food and Drug Administration. Reuters adds that the FDA has issued 11 consumer warnings this year about herbal supplements containing prescription drug ingredients.

Study: Herbal supplements often contain ED medication ingredients.

Reuters (5/10, Grens) reports that many herbal dietary supplements that purport to enhance men's sexual stamina actually contain the same active ingredients that are found in erectile dysfunction treatments such as Pfizer's Viagra (sildenafil), according to a studypublished online May 1 in the Journal of Sexual Medicine. Pfizer researcher Neil Campbell and colleagues analyzed 91 samples from 58 herbal supplements they purchased from small retail stores in Atlanta and Baltimore. They found that 81 percent of the supplements, with such names as Rize 2 The Occasion and Stiff 4 Hours, were labeled as containing all natural ingredients but actually contained sildenafil, tadalafil, which is marketed as Cialis, or a similar drug product not approved by the Food and Drug Administration. Reuters adds that the FDA has issued 11 consumer warnings this year about herbal supplements containing prescription drug ingredients.

Metformin appears safe for heart failure patients, analysis finds

Metformin appears to be a safe option for glycemic control in heart failure patients, according to a recent meta-analysis.

The analysis included nine observational studies of the association between metformin and morbidity and mortality in patients with diabetes and heart failure, the majority of which were published in 2010. According to the analysis, patients on metformin had about 20% lower mortality than controls, who were most commonly taking sulfonylurea drugs: 23% versus 37% (P<0.001). A small but not statistically significant reduction in all-cause hospitalizations was also found in the metformin patients compared to controls.

The researchers also looked at the subgroups of patients who had reduced left ventricular ejection fraction (LVEF) or chronic kidney disease, and in both cases, metformin was associated with slightly reduced mortality (pooled adjusted risk estimates, 0.91 and 0.81, respectively). No increased risk of lactic acidosis was found in metformin patients. The results were published online byCirculation Heart Failure on March 18.

Despite historical concerns about its use in heart failure patients, metformin appears to be at least as safe as other glucose-lowering treatments for these patients (including the high-risk groups with reduced LVEF and kidney disease) and should be the treatment of choice, the study authors concluded. This finding supports both current guidelines from medical specialty societies and recent decisions by the FDA and Canadian regulators to remove a black-box contraindication concerning use of metformin in heart failure patients.

The authors did acknowledge a risk of confounding because the evidence is based entirely on observational trials, but they said that randomized trials in this patient population are rare and not likely to be expanded. However, a number of studies in animal models of heart failure have suggested potential benefits of metformin, the authors noted.

Protein Identified in Cancer Drug Resistance.

Researchers have identified a new role for MDM2, a known regulator of the tumor suppressor protein called p53, in shutting down cell death signals. The investigators found that resistance to the drug lapatinib (a tyrosine kinase inhibitor) in different types of breast cancer could be traced to high levels of MDM2, which promoted cell survival through a particular pathway. In a mouse model, an MDM2 inhibitor reduced the growth of tumors from lapatinib-resistant breast cancer cells. The Science Signaling findings suggest that other drugs targeting tyrosine kinases may also be vulnerable to resistance through this mechanism.

CMS data reveal wide pricing variation at hospitals across country.

The data released by CMS Wednesday, revealing wide variations in hospital pricing across the country, is reported heavily by the national press, both online and in print, in addition to one nightly news broadcast. Using descriptors such as "wild," "stunning," and "staggering," these accounts focus on the implications the gaps in cost have on consumers, namely those who are uninsured. Some note that along with releasing the data, HHS announced a new rule requiring hospitals to disclose their pricing information. Beyond this, several of the sources also quote HHS officials including Secretary Kathleen Sebelius and Medicare Director Jonathan Blum.

        First, Wednesday night, ABC World News (5/8, story 4, 0:35, Sawyer, 7.43M) reported on the new figures which show that "some hospitals have been charging up to seven times as much for procedures as other hospitals, even hospitals in the same city." The piece explained, "People with good insurance may not see a difference in their out of pocket costs, but the estimated 80 million uninsured and underinsured can shop around for a better price."

        The Wall Street Journal (5/9, Radnofsky, Barry, Subscription Publication, 2.29M) reports on the records released Wednesday by the Centers for Medicare and Medicaid Services, which show the prices for common treatments at 3,337 hospitals across the country. The figures reveal wide variation in pricing, even for hospitals in the same region or city. Though many praised the agency's decision to release the data, and it is garnering a good amount of attention, the article notes that it is unlikely to lead to more uniform costs.

        On its front page, USA Today (5/9, A1, Kennedy, 1.71M) reports upon releasing the data, HHS also announced that "hospitals will now be required to tell patients how much they charge for procedures." HHS Secretary Kathleen Sebelius said in a conference call, "Currently, consumers don't know what a hospital is charging them or their insurance company for a given procedure, like a knee replacement, or how much of a price difference there is at different hospitals, even within the same city. This data and new data centers will help fill that gap." And more to this point, Jonathan Blum, acting principal deputy administrator and director of the Center for Medicare said, "Hospitals that charge two or three times the going rate will rightfully face higher scrutiny."

        Reuters (5/9, Morgan) also quotes Sebelius saying, "When consumers easily compare the prices of goods and services, (providers) have strong incentives to keep those prices low. But even basic information about health premiums and hospital charges has long been hidden from consumers. These rates can vary dramatically in ways that can't be easily explained."

        The AP (5/9, Cass, Neergaard) reports that Federal officials are calling the discrepancies a "mystery," as "the amounts are too huge to be explained by obvious differences among hospitals, such as a more expensive regional economy, older or sicker patients, or the extra costs of running a teaching hospital," according to Blum.

        The Los Angeles Times (5/9, Terhune, Poston, 692K) reports that the "wildly varying" data call "into question medical billing practices just as U.S. officials try to rein in rising costs."

        As the Washington Post (5/9, Andrews, Cameron, Keating, 489K) puts it, in a piece presenting analysis of the data, "The numbers reveal a tremendous, unexplained variation in cost of services."

        Explaining the data further, Bloomberg News (5/9, Wayne) reports that CMS "released the prices for the 100 most frequently billed in-patient services at hospitals, such as kidney and urinary tract infections, pacemaker implantations and chronic obstructive pulmonary disease." Treatment of psychoses "showed the greatest price discrepancies, with the most expensive hospital charging $144,523, more than 52 times its cheapest peer." The "most common procedure in the data, treatment of simple pneumonia and lung inflammation with complications, had prices ranging from $5,093 to as much as $124,051."

        Beyond the national press, the data receives heavy local coverage, with many sources reporting on the price differences between regional hospitals, and offering examples. For its part, the Los Angeles Times (5/9, Terhune, 692K) reports that the data "shed[s] new light on how much hospital bills vary across Southern California." The piece illustrates this by comparing the cost of joint replacement at Cedars-Sinai in Los Angeles, Keck Hospital at the University of Southern California, and Prime Healthcare's Centinela Hospital Medical Center in Inglewood, all well above $100,000, with that of Hoag Orthopedic Institute in Irvine and Kaiser's Los Angeles Medical Center, each hovering around $50,000.

DEA designation clears anti-obesity medication for US launch.

The Wall Street Journal (5/8, Stynes, Subscription Publication, 2.29M) reports Arena Pharmaceuticals Inc. announced Tuesday that the US Drug Enforcement Administration filed a final rule to designate its weight-loss therapy, Belviq (lorcaserin HCI), under Schedule IV of the Controlled Substances Act. The US Food and Drug Administration approved Belviq last summer, making it the first anti-obesity medication approved by the agency in more than 10 years.

        According to Bloomberg News (5/8, Edney), the DEA reviewed Belviq because the FDA "said the active ingredient, lorcaserin, can produce a high or hallucinogen effect at doses greater than those used to produce weight loss." The Schedule IV level is the second-least restrictive classification under the rule (pdf), which the DEA made public yesterday.

        The U-T San Diego (5/8, Fikes, 242K) adds that the DEA designation cleared the way for Arena to begin selling Belviq on the US market. Sales "can begin 30 days from publication of the DEA approval," which Arena expects will be printed in today's Federal Register. Its marketing partner, Tokyo-based Eisai Pharmaceuticals, will manage the sales and distribution of Belviq in the US, Arena said in the announcement.

CMS to release data showing wide variations in hospital pricing.

Wednesday morning, HHS is set to release a data set encompassing the billing prices for popular procedures at over 3,000 of the nation's hospitals. The information, embargoed until midnight, still receives heavy coverage in major outlets, including a front-page story in the New York Times. Most of the articles focus on how "wildly" pricing varies from hospital to hospital, even within the same region or city, and attempt to suss out the implications of this news.         In the front-page piece, the New York Times (5/8, A1, Meier, McGinty, Creswell, Subscription Publication, 1.68M) reports that the Centers for Medicare and Medicaid Services will release data for 3,300 hospitals Wednesday which how "wildly different" and "wide variations" in pricing for common procedures, "not only regionally but among hospitals in the same area or city." Noting that hospitals sometimes charge 10 to 20 times what Medicare reimburses, the Times says the data raise "questions about how hospitals determine prices and why they differ so widely," adding that it "is likely to intensify a long debate over the methods that hospitals use to determine their charges." In an interview, Deputy Medicare Administrator Jonathan Blum said of releasing these figures, "Our goal is to make this information more transparent."         The Washington Post (5/8, Kliff, Keating, 489K) "Wonkblog" also reports on the data, noting that the figures reveal "a health-care system with tremendous, seemingly random variation in the costs of services." According to the article, experts say the variations are the result of "a health system that can set prices with impunity because consumers rarely see them - and rarely shop for discounts." This piece also quotes Blum, who said, "Historically, the mission of our agency has been to pay claims. We'll continue to pay claims, but our mission has also shifted to be a trusted source in the marketplace for information. We want to provide more clarity and transparency on charge data."         The Huffington Post (5/8, Young) calls some of the pricing differences "staggering," and notes that "people without health insurance pay vastly higher costs for care when less expensive options are often available nearby." The article also focuses on the fact that until now, "Hospitals have protected their price lists - documents known as charge masters - as closely guarded secrets." But with this data, CMS "lays out for the first time and in voluminous detail how much the vast majority of American hospitals charge for the 100 most common inpatient procedures billed to Medicare."         In a piece for the Time (5/8, 3.38M) "Swampland" blog, Steven Brill, who wrote the March 4 Time cover story "Bitter Pill: Why Medical Bills Are Killing Us," reports that Wednesday morning, HHS Secretary Kathleen Sebelius will announce "a groundbreaking initiative that will take a lot of the secrecy out of hospital billings." Brill writes, "CMS public-affairs director Brian Cook told me that Sebelius' action today comes in part in response to... 'Bitter Pill.'"

Increasing Accumulations of Coronary Artery Calcium Linked with Heart Attacks and Death.

Individuals with 300 units or more in accumulations of coronary artery calcium over a 2.5 year follow-up were more than six times as likely to suffer from a heart attack or die from heart disease than individuals who didn't have increasing accumulations in a recent Journal of the American College of Cardiology study of 6778 people aged 45 to 84 years. Nearly half (49.9%) of the participants had coronary artery calcium in their initial scans, and most of them (84.8%) continued to accumulate coronary artery calcium, as measured in subsequent CT scans during follow-up.

Effective Patient Education Strategies for Lowering Phosphorus in CKD.

A recent literature review that explored the challenges and solutions in educating patients with CKD to lower serum phosphorus while avoiding protein insufficiency and hypercalcemia found that emerging educational initiatives include food labeling using a "traffic light" scheme, motivational interviewing techniques, and the Phosphate Education Program – whereby patients no longer have to memorize the phosphorus content of each individual food component, but only a "phosphorus unit" value for a limited number of food groups. ThePatient Preference and Adherence review also found that phosphorus binders provide several advantages to patients, including prolonged survival and more flexibility than dietary restrictions.

CKD Linked to Gout Prevalence in the United States.

In an analysis of NHANES data from 1988 to 1994 and 2007 to 2010, the prevalence of gout was 2% to 3% among participants without CKD, 4% among participants with CKD stage 1, 6% to 10% for stage 2, 11% to 13% for stage 3, and over 30% for stage 4. After adjusting for demographic characteristics, CKD-related medical disorders, and serum uric acid, individuals with stage 4 CKD had about a threefold higher prevalence of gout than those without CKD. The Seminars in Arthritis and Rheumatism study also found a higher prevalence of gout in patients with albuminuria.

Studies attribute health cost slowdown to factors beyond recession.

Two studies published Monday in the journal Health Affairs, one by Harvard Medical School researchers and one by Harvard health economists, contribute further evidence to the notion that the recent healthcare cost slowdown may be about more than just the recession. Both receive considerable national coverage Tuesday, and though they are distinct studies which come to slightly different conclusions, all outlets report on them together, noting the implications the research as a whole will have on the larger healthcare debate. Several sources use the term "optimistic" when discussing them.

        The New York Times (5/6, Lowrey, Subscription Publication, 1.68M) reports on "major new studies" out of researchers from Harvard University, the Kaiser Family Foundation, and elsewhere, which have all looked into the "bigger-than-expected slowdown in health spending" from the past few years and concluded that not all of it stems from the recession. Indeed, "David M. Cutler, the Harvard health economist and former Obama adviser, estimates that, given the dynamics of the slowdown, economists might be overestimating public health spending over the next decade by as much as $770 billion." Two of these studies were released Monday in the journal Health Affairs: one by Cutler and one by Michael E. Chernew of the Harvard Medical School.

        The Wall Street Journal (5/7, Mathews, Subscription Publication, 2.29M) reports further on the two new analyses looking into the recent healthcare growth slowdown. The article quotes Chernew discussing his paper, saying, "We find a much bigger effect beyond the simple recession story. It's certainly reasonable to believe the slowdown will persist." And Cutler said of his, "It's all adding up to a story that says it looks like it's different from what we've seen in the past."

        Bloomberg News (5/7, Wayne) reports on the studies, which together indicate that the slowdown may "signal potential structural changes in the industry that could cut health-care inflation and save the U.S. hundreds of billions of dollars." The article adds that the findings "will be part of the debate between President Barack Obama and Republicans over how to control spending growth for Medicare and Medicaid."

        Reuters (5/7, Begley) reports that according to the analyses, Medicare spending would be over $400 billion less than officials have predicted through 2021 and overall health spending would fall by $770 billion. This, the article points out, could greatly reduce the urgency lawmakers feel to make large reforms to government health programs.

        As the NPR (5/7, Rovner) "Shots" blog puts it, "While not solved, the growth in health spending has definitely slowed."

        The Kaiser Health News (5/7, Rau) "Capsules" blog calls the studies "optimistic," though it points out that "neither study can pinpoint what factors exactly are responsible."

        Similarly, the Health Affairs Blog (5/7, Fleming) calls the studies published in their journal "cautiously optimistic that the slowdown in health care spending is here to stay."

        Also reporting on the studies and their implications are the PBS (5/7, Kane) "The Rundown" blog and Modern Healthcare (5/7, Evans, Subscription Publication, 71K).

FDA releases proposal to strengthen tanning bed regulations.

The Food and Drug Administration's release of a proposal Monday to reclassify sunlamp products and require labels warning against the use of the devices by young people garnered extensive print and online media coverage. Nearly all of the news sources provided excerpts of comments made by FDA officials and by the American Academy of Dermatology's Regulatory Policy Committee Chair Dr. Mary Maloney during a conference call with reporters yesterday to announce the proposal for stricter regulations.

        The New York Times (5/7, A14, Tavernise, Subscription Publication, 1.68M) reports that the FDA on Monday announced"proposed new regulations for tanning beds that would require their makers to affix labels warning young people not to use them." The agency "said the proposal was its first step toward potentially restricting access to the beds altogether for minors." According to the American Academy of Dermatology, "nearly 28 million Americans use tanning beds every year."

        The Los Angeles Times (5/7, Healy, 692K) "Science Now" blog notes that in announcing the proposed regulation on Monday, FDA Commissioner Dr. Margaret A. Hamburg said the changes would "address some of the risks associated with sunlamp products" and would ensure consumers have "clear and consistent information." Essentially, the FDA's proposed new rule "would require manufacturers to show that their products meet certain performance and safety standards and that they are prominently labeled with warnings against their use by people younger than 18. The warnings would also be required to encourage all frequent users to be screened regularly for skin cancer."

        Bloomberg News (5/7, Edney) adds that during a conference call with reporters, FDA Center for Devices and Radiological Health Director Dr. Jeffrey Shuren explained that the warnings would "go on tanning beds as well as in brochures on the machines." The FDA is accepting public comments on the proposed rules for 90 days and the earliest it would "issue a final order is the end of this year and then there would be a 15-month implementation period, Shuren said."

        The Wall Street Journal (5/7, B3, Dooren, Subscription Publication, 2.29M) notes that the FDA's proposal was prompted by a 2010 recommendation from an independent panel of experts, which suggested the agency strengthen the regulation of tanning beds, which are presently listed in the same medical device category as band aids. The Journal quotes AAD's Regulatory Policy Committee Chair Dr. Mary Maloney as saying during the conference call, "Skin cancer no longer affects [only] older men." Dr. Maloney says melanoma is the most common form of cancer among young people between age 25 and 29. Moreover, 32 percent of girls in their senior year of high school reported using tanning beds in 2011, according to the data from the Centers for Disease Control and Prevention.

        CQ (5/7, Adams, Subscription Publication) adds that during the conference call, Dr. Shuren said the FDA "is not trying to burden salons but rather to educate consumers." He said the "responsibility for the new warnings falls on the companies that make the products, not salons." According to CQ, Shuren also noted that the AAD "found a 75 percent increase in the risk of melanoma" among individuals who "have been exposed to ultraviolet radiation from indoor tanning, and the risk ratchets up every time someone steps into a tanning bed."

        Meanwhile, Washington Post (5/7, Dennis, 489K) reports National Research Center for Women and Families President Diana Zuckerman "described the FDA proposal as 'very weak,'" noting that proposal "would not require clinical testing, 'which would entail making sure that consumers are not burned if the tanning bed is used as directed,'" and objecting to the fact that although the FDA is "recommending that children under 18 not use tanning beds, there is no enforcement mechanism to stop them."

        The AP (5/7, Perrone) adds that Dr. Maloney "said the FDA action is an important first step, but that her group would continue to push for a ban on the sale and use of tanning beds for people under age 18." According to data from the AAD, an "estimated 2.3 million US teenagers tan indoors each year."

        USA Today (5/7, Szabo, 1.71M) notes that several states, including "California and Vermont, already prohibit minors from using tanning beds, as do the cities of Chicago and Springfield, Ill. New York and New Jersey ban children under age 17 from using tanning beds."

        The FDA's proposal to bolster tanning beds regulations is also covered by the New York Times (5/7, Tavernise, 1.68M) "Well" blog, Reuters (5/7, Clarke), The Hill (5/7, Wilson, 21K) "RegWatch" blog, the Time (5/7, Sifferlin, 3.38M) "Healthland" blog, MedPage Today (5/7, Gever), HealthDay (5/7, Reinberg) and MyHealthNewsDaily (5/7, Rettner).

Azithromycin not associated with increased cardiovascular risk in the general population

Azithromycin was not associated with an increased risk of death from cardiovascular causes in a general population of young and middle-aged adults, a Danish study found.

Researchers conducted a nationwide historical cohort study involving Danish adults in a registry database, ages 18 to 64, from 1997 through 2010. They estimated rate ratios for death from cardiovascular causes, comparing 1,102,050 uses of azithromycin to no use of antibiotic agents (matched in a 1:1 ratio according to propensity score) and 1,102,419 uses of azithromycin to 7,364,292 uses of penicillin V.

Results appeared in the May 2 New England Journal of Medicine.

Risk of death from cardiovascular causes significantly increased with current use of azithromycin compared to no antibiotic use (rate ratio [RR], 2.85; 95% CI, 1.13 to 7.24). There was no significantly increased risk with recent or past use. The risk of noncardiovascular death was also higher with current use of azithromycin compared to no antibiotic (RR, 1.60; 95% CI, 1.00 to 2.54).

However, when compared to penicillin V in an unadjusted analysis, azithromycin was not significantly associated with an increased risk of death from cardiovascular causes during current use (RR, 0.78; 95% CI, 0.47 to 1.28) or recent or past use. In an analysis adjusted for propensity scores, azithromycin was not associated with a significantly increased risk of death from cardiovascular causes during current use (RR, 0.93; 95% CI, 0.56 to 1.55), recent use (RR, 0.75; 95% CI, 0.34 to 1.62) or past use (RR, 0.92; 95% CI, 0.60 to 1.42) compared with penicillin V.

Researchers wrote, "[O]ur findings indicate that the risk of cardiac toxic effects associated with azithromycin may not be generalizable but may rather be limited to high-risk populations. The implications of these findings for clinical decision making are reassuring; they indicate that for the general population of patients seen in office practice, azithromycin can be prescribed without concern about an increased risk of death from cardiovascular causes, whereas the benefits of therapy need to be weighed against the risk of death from cardiovascular causes among patients with a high baseline risk of cardiovascular disease."

An accompanying editorial from the FDA noted that in March the agency revised the azithromycin product labels to reflect other study results that showed azithromycin can prolong the QT interval.

"Pharmacologic and epidemiologic data point to lethal arrhythmias as a potential consequence of QT-interval prolongation with use of azithromycin, other macrolides, and fluoroquinolones," the researchers wrote. "This possibility should give clinicians pause when they're considering prescribing antibacterial drugs, especially for patients with preexisting cardiovascular risk factors or clinical conditions in which antibacterial drug therapy has limited benefits."

Creatine May alleviate fibromyalgia symptoms, improve strength.

Reuters (5/3, Stokes) reported that creatine supplements may be a good non-drug alternative to fibromyalgia medications, suggests a study published in the April 1 issue of the journal Arthritis Care & Research. In the double-blind, randomized, placebo-controlled trial, the researchers at the University of São Paulo School of Physical Education and Sports in Brazil gave 23 patients with fibromyalgia daily doses of either creatine supplements or placebo tablets for 16 weeks. They found that the 15 trial participants in the creatine arm had a significant improvement in pain levels, moods, sleep quality and muscle strength compared to the 13-person placebo group, which reported no changes in the aforementioned qualifiers. Reuters noted that although at present, there are a number of FDA-approved treatments on the market - Cymbalta (duloxetine) and Savella (milnacipran), which are antidepressants; Lyrica (pregabalin), which was initially developed for nerve pain; and several anti-seizure therapies and sedatives - they have not been especially effective in alleviating fibromyalgia symptoms and many of them include unpleasant side effects.

Group releases new recommendations on PSA testing.

News that the American Urological Association has issued new recommendations on PSA screening received moderate coverage in print, in two of the nation's most widely circulated papers, and online, as well as on one of last night's national news broadcasts. Sources characterize the new recommendations as a "stark shift," a "major shift," and "a major break from the past."

        NBC Nightly News (5/3, story 4, 1:40, Williams, 7.86M) reported that the American Urological Association has released new guidelines on PSA screening, which will make the issue of prostate cancer screening "easier to navigate."

        USA Today (5/4, Szabo, 1.71M) reported that the AUA, "which has staunchly defended the PSA screening test in recent years, says healthy men under 55 don't need routine annual screening." Meanwhile, "men ages 55 to 69 who are considering the PSA should consult their doctors about the test's benefits and risks, according to a new policy." Previously, the AUA had recommended that "healthy men ages 40 and up...ask their" physicians about the test.

        The New York Times (5/4, Pollack, Subscription Publication, 1.68M) reported that "screening is also not recommended for men 70 and older." The Times points out that the AUA "had staunchly defended the benefits of screening men with the prostate test, even after a government advisory committee, the United States Preventive Services Task Force, said in 2011 that healthy men should not be screened because far more men would be harmed by unnecessary prostate cancer treatments than would be saved from death."

        The Los Angeles Times (5/4, Kaplan, 692K) "Science Now" blog reported that "the new guideline also acknowledges that many men get treatment that's too aggressive for their disease. 'Although prostate-cancer-specific mortality and the need for related palliative care is decreased by screening, quality of life may be impaired as a result due to lasting impairment in urinary, bowel and sexual function,' the guideline states. 'Thus, personal preferences should play a large role in both a decision to screen and in prostate cancer management if diagnosed.'"

        On its website, CBS News (5/4, Jaslow) reported that the AUA "determined the mortality benefits of preventing prostate cancer death with a PSA test for men ages 55 to 69 amounted to one male life spared for every 1,000 men screened over a decade."

        The Boston Globe (5/4, Kotz, 250K) reported that, according to Dr. H. Ballentine Carter, who led the group that wrote the new recommendations, "This new guideline has been in the works for two years," and is "based on evidence from clinical trials." The earlier "recommendations, he added, were based on what urologists considered the 'best practice' of medicine based on their own clinical experience." Also covering the story are The Oregonian (5/4, 237K), Reuters (5/4, Pittman), Medscape (5/4, Chustecka),MedPage Today (5/4, Bankhead), HealthDay (5/4), and the NPR (5/4, Hensley) "Shots" blog.

5 Drugs You May Need to Avoid or Adjust if You Have Kidney Disease

National Kidney Foundation link

Medications save and improve lives, but it can be easy to overlook their risks and side effects, especially if you don't think they apply to you. Twenty-six million Americans have chronic kidney disease and most don't know it.

If you don't know how well your kidneys are working, you may not realize that certain medications could be damaging your kidneys and other parts of your body. Both prescription and over-the-counter medications are filtered by the kidneys. This means that your kidneys degrade and remove medications from the body.

When your kidneys aren't working properly, medications can build up and cause you harm. It's important to get your kidneys checked and to work with your doctor to make any adjustments to your medication regimen, such as dosing changes or substitutions. This will help prevent any negative effects from the medication, including further kidney damage.

You can determine your level of kidney function with a blood test for serum creatinine to calculate an eGFR measurement. An eGFR estimates how well your kidneys are filtering wastes from the blood.

The National Kidney Foundation encourages you to learn more about the health of your kidneys in order to protect these vital organs when taking medications. Always speak with your clinician and pharmacist to determine whether the medications that you're taking should be adjusted based on your kidney function. Only make changes to your prescription medications with the supervision of your trained medical practitioner. Ask questions and evaluate the risks and benefits based on your specific health needs.

Here are 5 common types of prescription and over-the-counter medications may need to be adjusted or replaced if you have kidney damage.

1. Cholesterol medications. The dosing of certain cholesterol medications, known as "statins", may need to be adjusted if you have chronic kidney disease.
2. Pain medications. If you have decreased kidney function some over-the-counter and prescription pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), are not recommended because they can reduce blood flow to the kidneys. Certain narcotic pain medications can build up in the body and cause serious problems for patients with chronic kidney disease.
3. Anti-microbial meds. Many anti-fungal, antibiotic and antiviral medications are cleared by the kidneys. It's important that you and your clinician are aware of your level of kidney function so that a kidney-safe medication can be prescribed for your treatment.
4. Diabetes medications. Insulin and certain medications used by people with diabetes are cleared by the kidneys. Because diabetes is a leading cause of kidney disease, it's important that those with diabetes control their blood sugar levels. Blood sugar control typically involves a combination of diet, physical activity, and medication. If you have diabetes and chronic kidney disease, check with your physician to see if any dosing changes need to be made based on your level of kidney function.
5. Upset stomach/antacid medications. This group of over-the-counter medications can disrupt the body's electrolyte balance if you have chronic kidney disease. Check with your doctor to see if these are safe for you to use.

For more information about medications that may need to be adjusted or avoided if you have chronic kidney disease, click here.