Sunday, February 10, 2013

Fruits and Vegetables Reduce Metabolic Acidosis in CKD Patients.

In 71 patients with hypertensive stage 4 CKD, adding fruits and vegetables or an oral alkaline medication for 1 year caused an increase in 1-year plasma total carbon dioxide (PTCO2), which is consistent with a lessening of metabolic acidosis. PTCO2 was higher in patients receiving bicarbonate than in those receiving added fruits and vegetables. Also, kidney function did not change during the study, while urine indices of kidney injury were lower after 1 year in both groups. Blood potassium levels did not rise in either group. The findings are published in the Clinical Journal of the American Society of Nephrology.

Omega-3 Fatty Acids Linked to Lower Risk of Death in Patients Starting Dialysis.

Omega-3 fatty acid levels in the blood are linked with a lower risk of sudden cardiac death throughout the first year of hemodialysis, according to a Kidney International study of 100 patients who died of sudden cardiac death during their first year of hemodialysis and 300 patients who survived. The odds of sudden cardiac death at 1 year for the second, third, and fourth quartile groups with respect to omega-3 fatty acid levels were 0.37, 0.22, and 0.20, respectively, compared with the lowest quartile. A significant inverse relationship was maintained even during the highest-risk first few months on hemodialysis.

Frequent Hemodialysis Linked with Increased Access-Related Risks.

The risk for an access event (repair, loss, or access-related hospitalization) was 76% higher with daily hemodialysis compared with conventional hemodialysis in a study of 245 hemodialysis patients. The daily group had 33 repairs and 15 losses and the conventional group had 17 repairs, 11 losses, and 1 hospitalization. Similar trends were seen with nightly hemodialysis compared with conventional hemodialysis among 87 patients, although the results were not statistically significant. The findings are published in the Journal of the American Society of Nephrology.

Recommendations on Dietary Fats May Be Misguided.

Over 39 months, men instructed to reduce saturated fats to less than 10% of intake and to increase omega-6 linoleic acid, a polyunsaturated fat, to 15% of intake had a higher risk of dying from all causes, as well as from cardiovascular and coronary heart disease, compared with men who received no dietary advice. The study involved 458 men aged 30 to 59 years who had recently had a coronary event. The BMJ findings, based on recovered data from the Sydney Diet Heart Study, suggest that the American Heart Association guidelines on omega-6 polyunsaturated fatty acids may be misguided.

ACE inhibitor may increase walking time in patients with PAD.

Forbes (2/5, 928K) blogger Larry Husten writes, "Giving an ACE inhibitor to people with peripheral artery disease (PAD) and intermittent claudication reduces pain and increases walking time, according to a new study published in JAMA. Currently the pharmacologic options for this patient population are few and have limited efficacy."
        MedPage Today (2/6, Bankhead) reports that researchers found that "the average pain-free walking time increased by more than 60% and maximum walking time more than doubled after 6 months of treatment with the ACE inhibitor." Nearly "all secondary outcomes improved significantly with ramipril versus placebo, including ankle-brachial index (ABI), an impairment scale specific to peripheral arterial disease (PAD), and functional aspects of health-related quality of life."
        Heartwire (2/6, Busko) reports that in an editorial accompanying the study, Dr Mary McGrae McDermott wrote that "this randomized controlled trial shows very promising results for the ability of ramipril to improve walking, and physicians should consider using it for patients who are troubled by symptoms of PAD."
        But, "one thing that's not clear, according to McDermott, is how well improvements in treadmill walking translate into real life,"HealthDay (2/6, Norton) reports. Medwire (2/6, McDermid) also covers the story.

Diet soda may be a more potent alcohol mixer than regular soda

On its website, ABC News (2/6, Vermani) reports that according to a study published in the journal Alcoholism, mixing alcoholic drinks with diet soda may result in a higher breath alcohol content than mixing drinks with regular, full-calorie soda. Participants in the study who consumed "the vodka-diet drink cocktails had a significantly higher breath alcohol content" than vodka-regular soda drinks, "and had the highest degree of behavioral impairment among the groups." The study's lead author explained, "Participants who drank diet soda with vodka had blood alcohol contents as high as 18 percent more than when sugar-containing mixers were used."
        The CNN (2/6, Wade) "The Chart" blog points out that the study was very small, "only eight women and eight men," but the findings "closely match previous research linking diet drinks and increased alcohol levels in the body." Researchers explained the reason why people get more intoxicated drinking alcohol mixed with diet soda "has to do with digestion. The diet soda mixture passes quickly through the stomach, putting alcohol into our bloodstream faster." When the stomach encounters regular soda and liquor, it "treats this combination as if it's food," which delays the release of alcohol into the body, "spreading it out over a longer period of time."
        HealthDay (2/6, Gordon) adds that "researchers didn't notice a difference between men and women in this study." The study's lead author said, however, that "women are more inclined to consume alcoholic beverages with diet soda." The American Beverage Association disagreed with the study's findings. In a statement released Tuesday, the association said, "This paper, which looks at only 16 people, does not show that mixing diet soft drinks with alcohol causes increased intoxication. Rather, it simply supports the long known fact that consuming calories - from any food or beverage - along with alcohol slows down its impact."

High-Dose Vitamin C Linked with Kidney Stones.

High-dose vitamin C supplements (typically 1000 mg per tablet) are linked with a dose-dependent twofold increased risk of kidney stone formation among men, according to an 11-year study of more than 23,000 men. The observed increase in risk did not apply to a normal dietary intake of vitamin C from fruit and vegetables. Because there are no well-documented benefits of high-dose vitamin C supplements, it's wise for individuals with a history of kidney stones to avoid them, the researchers said. The findings are published inJAMA Internal Medicine.

Researchers Link Gout to Kidney Disease.

A strong dose–response association exists between impaired kidney function and prevalent gout in US adults, according to aSeminars in Arthritis & Rheumatism analysis of data from NHANES 1988–1994 and 2007–2010. The prevalence of gout was 2% to 3% among participants without CKD, 4% among those with CKD stage 1, 6% to 10% for stage 2, 11% to 13% for stage 3, and more than 30% for stage 4. The prevalence of gout was higher among individuals with lower average eGFRs and higher levels of albuminuria, the investigators found.

Some but not all antidepressants associated with QT prolongation

Citalopram and some other antidepressants were associated with prolongation of the QT interval, a new study found.
The cross-sectional study used electronic health record data on 38,397 adult patients treated between 1990 and 2011 in one Massachusetts health system. All of the patients had a prescription for an antidepressant or methadone (which was included to demonstrate assay sensitivity because of its known effect on QT interval) and had an electrocardiogram (EKG) recorded between 14 and 90 days of the prescription. Studied antidepressants included citalopram, escitalopram, fluoxetine, paroxetine, sertraline, amitriptyline, bupropion, duloxetine, mirtazapine, nortriptyline and venlafaxine.
Results were published by BMJ on Jan. 29.
Researchers found a dose-response association with QT prolongation for citalopram (adjusted beta, 0.10; P<0.01), escitalopram (adjusted beta, 0.58;P<0.001) and amitriptyline (adjusted beta, 0.11; P<0.001), but not for the other antidepressants. Bupropion was associated with QT shortening (adjusted beta, 0.02; P<0.05). More than 400 study subjects had an EKG before and after a dose increase; 59 patients whose citalopram dose was increased from 10 mg to 20 mg had a significant increase in QT (mean increase, 7.8 ms; adjusted P<0.05), as did 107 patients whose dose went from 20 mg to 40 mg (mean increase, 10.3 ms; adjusted P<0.01). Thirteen patients whose bupropion dose increased from 100 mg to 200 mg had a significant decrease in QT (mean decrease, 19.2 ms; adjusted P<0.05).
The study confirmed an association between citalopram and QT prolongation that had been previously identified by other research and FDA warnings, the study authors concluded. Modest prolongation was also found with amitriptyline and escitalopram, but not the other drugs, suggesting that there might some variation in risk within the treatment class. The authors cautioned, however, that the effect sizes were small and that their study population was older and sicker than the average outpatient cohort, since physicians are more likely to order EKGs for such patients.
The study can't answer the question of whether patients on antidepressants should routinely receive EKGs, the authors said, but it may suggest that bupropion treatment would be a reasonable alternative to increasing a patient's dose of citalopram. They called for randomized trials to confirm these apparent associations.

USDA to propose school lunch standards.

The AP (2/1, Jalonick) reported that the USDA "for the first time is proposing broad new standards to make sure all foods sold in schools are more healthful, a change that would ban the sale of almost all candy, high-calorie sports drinks and greasy foods on campus." The new rules would require school vending machines to "start selling water, lower-calorie sports drinks, diet sodas and baked chips instead. Lunchrooms that now sell fatty 'a la carte' items like mozzarella sticks and nachos would have to switch to healthier pizzas, low-fat hamburgers, fruit cups and yogurt."
        USA Today (2/1, Hellmich, 1.71M) reported the USDA released "its proposed standards for 'competitive foods,' the name given to foods that are not part of the regular school meals." The proposed standards say that all competitive foods must "be either a fruit, a vegetable, a dairy product, a protein food, a whole-grain-rich grain product or a combination food that contains at least ¼ cup of fruit or vegetable." It must be no more than 200 calories per portion, and must also meet "requirements for sugar, fat and saturated fat. The meals must not contain any trans fat."
        The New York Times (2/2, A14, Nixon, Subscription Publication, 1.68M) added that the "rules are a major component of Michelle Obama's campaign to reduce the number of overweight children through exercise and better nutrition. A study by the National Academy of Sciences estimates that $2.3 billion worth of snack foods and beverages are sold annually in schools nationwide."
        Reuters (2/1, Heavey) reported Agriculture Secretary Tom Vilsack said his agency will propose new Federal rules governing snacks sold in schools - originally due in late 2011 - by April, when a 60-day public comment period will start before final rules get issued, possibly for the next school year. The delay gave schools and industry time to adjust and revamp meals in early 2012, said Vilsack.
        Other media sources that reported on this story include the Washington Post (2/1, Hicks, 489K), Bloomberg News (2/1, Armour),CQ (2/1, Ferguson, Subscription Publication), and The Hill (2/1, Viebeck, 21K), Reuters (2/2, Heavey, Abbott).

States consider loosening restrictions on physician assistants.

The Wall Street Journal (2/4, A3, Beck, Subscription Publication, 2.29M) reports on the debate that some states are facing over what physician assistants and similar midlevel health professionals will be permitted to do. PAs are licensed to practice medicine, but limited to what their advising doctor permits them in adherence to their state's rules. The demand for PAs is increasing, especially in primary care and in rural areas, and will continue to increase as more Americans receive coverage due to the Affordable Care Act. Now, some PAs, especially those in Kentucky, which has the strictest PA regulations in the country, are seeking reforms to expand their responsibilities.

Hypertension Treatments May Not Be Appropriate for Elderly Patients.

Hypertension definitions and risk factor guidelines used to determine treatment are no longer appropriate for a growing number of older individuals with the condition, said Dr. Reuven Zimlichman of Tel Aviv University. Addressing the 2013 International Conference on Prehypertension and Cariometabolic Syndrome, he noted more patients are developing isolated systolic hypertension (caused by arterial stiffening) rather than classic diastolic hypertension (caused by humoral changes and excessive vasoconstrictive factors) according to heartwire. Researchers must find a different medication that will improve or stabilize arterial elasticity, he added.

Same-Day Angiography, Heart Surgery Increases AKI Risk.

Performing heart surgery the same day as angiography increases the risk for acute kidney injury (AKI), while limiting this practice reduces AKI incidence. An Annals of Thoracic Surgery study involving 4440 patients undergoing cardiac surgery and preoperative diagnostic angiography found that those who received surgery and angiography on the same day were 58% more likely to develop stage 2–3 AKI. An institutional policy limiting the practice of surgery on the same day of angiography led to a 30% decrease of stage 1 AKI and 42% decrease of any AKI.

Growing Healthcare Costs Straining Texas Budget.

The AP Share to FacebookShare to Twitter (1/31, Tomlinson) reports, "Texas will use 'all the money that there is available to spend' in the state budget just paying the health care costs of the growing number of poor, disabled and elderly unless dramatic changes are made to the Medicaid system, the chairman of the Senate Finance Committee said Wednesday." Tommy Williams, a Republican, "called on fellow Texas lawmakers and state agency chiefs to prepare themselves to make tough choices but offered no details on how he would change Medicaid, the joint state-federal health program for 3.6 million Texans." At the hearing, "State budget analysts testified that the draft Health and Human Services budget calls for a 3 percent increase in state spending in the 2014-2015 budget cycle but acknowledged that Republican leaders asked them not to factor expected growth in Medicaid caseload or medical inflation into their budget forecast."
        The Texas Tribune Share to FacebookShare to Twitter (1/31, Aaronson) reports, "The Senate's proposed budget includes $22.5 billion in general revenue to fund Medicaid, the joint state-federal health providers for the poor, but does not account for anticipated increases in program costs because of caseload growth, medical inflation or higher utilization in the 2014-15 biennium." Further, "Texas legislators, who underfunded Medicaid last session in the midst of a budget shortfall, must also approve more than $4 billion in supplemental appropriations by March to avoid causing cash flow problems for the Health and Human Services Commission."
        The Dallas Morning News Share to FacebookShare to Twitter (1/31, Garrett) reports that Dr. Kyle Janek, the state's top social services official, told the senators "that Texas Medicaid program managers have come close to hitting their assigned goal of squeezing more than $2.2 billion in state savings in the current two-year budget cycle through various efficiencies and cost-containment moves." Specifically, "by Aug. 31, the efforts will have saved about $1.8 billion in general purpose revenue, or about 80 percent of what lawmakers hoped last session."

Lethal, Drug Resistant Germ Appearing In US Hospitals.

The Wall Street Journal Share to FacebookShare to Twitter (1/31, McCaughey, Subscription Publication) reports that according to announcement from public-health researchers in the journal Infection Control and Hospital Epidemiology last week, a lethal germ called CRK, which swept through the NIH Medical Center in Maryland, killing six, is appearing in hospitals around the country. According to researchers writing in another journal, Emerging Infectious Diseases, CRK, which cold not be contained by infection control precautions recommended by the CDC, poses "a major threat to public health."

Review Debunks Myths About Weight Loss, Obesity.

NBC Nightly News (1/30, story 11, 0:30, Williams) concludes its broadcast with a review published in the New England Journal of Medicine that debunks several myths surrounding weight loss. For example, "it's a myth that sex burns off calories by the hundreds. Here's another: the concept that small changes in diet can be the solution to losing weight. No, they say, the body adapts to that. They also say the idea that it's bad to lose a lot of weight quickly or that skipping breakfast will make you heavier are also myths."
        The New York Times Share to FacebookShare to Twitter (1/30, Kolata) "Well" blog says the review was written by David B. Allison, who directs the Nutrition Obesity Research Center at the University of Alabama at Birmingham, and colleagues. They "laid out seven myths and six unsubstantiated presumptions about obesity. They also list nine facts that, unfortunately, promise little in the way of quick fixes for the weight-obsessed. Obesity experts applauded this plain-spoken effort to dispel widespread confusion about obesity. The field, they say, has become something of a quagmire."
        The Los Angeles Times Share to FacebookShare to Twitter (1/30, Kaplan) "Booster Shots" blog notes the review cited a "randomized, controlled clinical trial that followed 13,000 children for more than six years found 'no compelling evidence' that breastfeeding staves off obesity." While there is some amount of physical education that "would help fight childhood obesity, P.E. classes in their current form have not been shown to reduce BMI or obesity in kids on a consistent basis," the review also found. The researchers also said experimental evidence "shows that readiness isn't related to diet results."
        Bloomberg News Share to FacebookShare to Twitter (1/30) says researchers found that six minutes of sexual activity "uses up only 14 more calories than does six minutes of watching TV." Research shows "that bigger goals lead to better results and, in the long term, crash diets lead to about the same amount of weight loss as slower, more moderate ones do. Another myth: the notion that adding a little bit of exercise to one's daily routine or cutting out small snacks can lead to significant weight loss."
        The AP Share to FacebookShare to Twitter (1/31, Marchione) notes another myth debunked by researchers: "Snacking leads to weight gain. Fact: No high quality studies support that, the authors say." Some things "may not have the strongest evidence for preventing obesity but are good for other reasons, such as breastfeeding and eating plenty of fruits and vegetables, the authors write. And exercise helps prevent a host of health problems regardless of whether it helps a person shed weight."

Medicare Adjusting Reimbursement For Dialysis.

The Washington Post Share to FacebookShare to Twitter (1/31, Whoriskey) reports, "The Medicare system is recalculating how much it will reimburse hospitals and clinics for the drugs used to treat dialysis patients after federal auditors found recently that the program could save as much as $880 million annually." An August analysis by the Post "showed that the government was overspending by hundreds of millions for just one group of those drugs." This occurred because the government was reimbursing for a dose that was higher than most people received. Dennis Cotter, president of the Medical Technology and Practice Patterns Institute, a research group, who called for price changes in 2011, said, "It's good that Medicare is finally going to set a new, more accurate price. It's unfortunate that they could have done this two years ago. This has so far cost taxpayers more than $1.6 billion."

Reducing SBP And LDL, In Addition To Glucose Control, May Cut CV Risk In T2D.

Heartwire Share to FacebookShare to Twitter (1/30, Stiles) reports that diabetes patients "who kept their systolic blood pressure (SBP), low-density-lipoprotein cholesterol (LDL-C), and glycosylated hemoglobin (HbA1C) levels all under control showed a 2.5-fold drop in risk of cardiovascular-disease hospitalization over six years, compared with those who controlled none of the three risk factors, in an observational study with >26 000 patients." Investigators found that "most of the observed benefit came from maintenance of SBP and LDL-cholesterol per guidelines, that is <130 mm Hg and <100 mg/dL, respectively, with less of a contribution from achieving glycemic control, HbA1C <7%." The research was published online in the Journal of General Internal Medicine.

Study Links Timing Of Meals To Weight Loss.

NBC Nightly News (1/29, story 8, 2:10, Williams) reports, "According to the new research, which matches what some folks have been saying for some time, timing could be everything when it comes to sensible eating." Dr. Frank Scheer at Brigham and Women's Hospital said, "This was the first long-term, large-scale study to really show that the timing of meal is important in the success of weight loss therapy." Researchers examined 420 overweight Spanish women on the Mediterranean diet. Despite consuming the same number of calories, those who "had had lunch before 3 p.m., lost an average of 22 pounds in 20 weeks, five pounds more than those who ate lunch later."
        USA Today Share to FacebookShare to Twitter (1/29) notes the International Journal of Obesity published the study, and the paper cites Sheer, who "says researchers don't know why weight loss was greater in the early eaters, but one hypothesis is that glucose (sugar) is processed differently depending on the time of day. Another theory is that the timing of meals can impact the circadian system (the body's clock) which may disrupt the proper function of the liver and fat cells." Dietician Elizabeth Ward, author of MyPlate for Moms: How to Feed Yourself and Your Family Better, "says this 'an interesting study, but it's an observational study, so it doesn't prove cause and effect.'"
        The Los Angeles Times Share to FacebookShare to Twitter (1/29, Macvean) "Booster Shots" blog notes the study was led by M. Garaulet of the University of Murcia, who said: "Recent studies link energy regulation to the circadian clock...emphasizing that the timing of food intake itself may have a significant role in weight regulation."
        Reuters Share to FacebookShare to Twitter (1/30) also cites Sheer, who said his team's findings suggest that, in the US, where dinner typically represents the largest meal, people who eat later dinners would have more trouble losing weight.
        The Huffington Post Share to FacebookShare to Twitter (1/29) adds, "Of note for the Spanish study, the timing and content of the other meals didn't have an impact on weight loss, although late lunchers were more likely to either eat less at breakfast or skip it altogether. That is supported by additional research - skipping or under-eating breakfast is associated with eating a greater calorie consumption later in the day and with overall heavier weight."

Sitagliptin, Glipizide Monotherapy Safe, Effective In Patients With T2D And ESRD Requiring Dialysis.

Renal and Urology News Share to FacebookShare to Twitter (1/30, Charnow) reports, "Sitagliptin and glipizide monotherapy is safe and effective in patients with type 2 diabetes and end-stage renal disease (ESRD) requiring dialysis, researchers reported online ahead of print in the American Journal of Kidney Diseases." Investigators came to this conclusion after conducting a "54-week, randomized, double-blind study" that "included 129 patients with type 2 diabetes and ESRD requiring dialysis."

Dual RAS Blockade Fails To Show Benefit In Meta-Analysis.

Heartwire Share to FacebookShare to Twitter (1/30, O'Riordan) reports, "A large meta-analysis of randomized trials comparing dual blockade of the renin-angiotensin system (RAS) with ACE inhibitors and angiotensin-receptor blockers (ARBs) failed to show any benefit in terms of reducing mortality compared with monotherapy." Researchers found that "dual blockade of the RAS was associated with an increased risk of hyperkalemia, hypotension, and renal failure, as well as a significantly increased risk of drug withdrawal due to adverse effects." HeartWire adds, "The 33 trials in the meta-analysis explored RAS blockade in patients with hypertension, diabetes, renal disease, or heart failure."

Updated sepsis guidelines released

ACP Hospitalist

San Juan, Puerto Rico—The 2012 Surviving Sepsis Guidelines Committee officially released updated guidelines for managing severe sepsis and septic shock during the Society of Critical Care Medicine's 42nd Congress here last week.
Recommendations were designated as strong (1) or weak (2) based on evidence that ranged from high (A) to very low (D). A new category of "ungraded" or "UG" evidence was introduced to signify recommendations the guidelines committee felt were not conducive to grading. Changes in the new version from the 2008 version include:
  • Initial fluid resuscitation with crystalloid (1B). The 2008 guidelines didn't specify a preference for crystalloid vs. colloid fluid resuscitation (1B).
  • Norepinephrine as the first-choice vasopressor to maintain mean arterial pressure ≥65 mm Hg (1B). The 2008 guidelines didn't specify a preference for norepinephrine vs. dopamine (1C).
  • Avoidance of neuromuscular blockers if possible in patients without acute respiratory distress syndrome (ARDS) (1C) and a short course (≤48 hours) of neuromuscular blockers for patients with early ARDS and a Pao2/Fio2 <150 mm Hg (2C). The 2008 guidelines suggested blanket avoidance of neuromuscular blockers if possible (1B).
  • A protocolized approach to blood glucose management that starts insulin dosing when two consecutive blood glucose levels are >180 mg/dL and targets an upper blood glucose ≤180 mg/dL (1A). The 2008 guidelines suggested targeting a blood glucose <150 mg/dL after initial stabilization (1C).
  • Oral or enteral (if necessary) feedings, as tolerated, rather than either complete fasting or provision of only intravenous glucose within the first 48 hours after a diagnosis of severe sepsis/septic shock (1C). The 2008 guidelines didn't discuss feedings.
  • Addressing goals of care, such as treatment plans and end-of-life planning as appropriate (1B), as early as possible, but within 72 hours of ICU admission (2C). The 2008 guidelines didn't specify a time period for advance care planning (1D).
Though many recommendations remained unchanged from the 2008 version, their quality of evidence grades were updated. For example, the strong recommendation to institute protocols for weaning and sedation was upgraded from "B" in 2008 to "A" in 2012 based on newer clinical trials. Likewise, the strong recommendation to promptly perform imaging studies to confirm a potential source of infection went from "C" to "UG".
"Most of these recommendations are appropriate for the severe sepsis patient in the ICU and non-ICU settings," the committee wrote. "In fact, the committee believes the greatest outcome improvement can be made through education and process changes for those caring for severe sepsis patients in the non-ICU setting and across the spectrum of acute care."
The guidelines committee comprised representatives of 30 international groups, with co-chairs and executive members appointed by the Society of Critical Care Medicine and European Society of Intensive Care Medicine governing bodies. The guidelines, based on literature published through fall 2012, also appear in the February issue of Critical Care Medicine and will appear in February'sIntensive Care Medicine .
—Jessica Berthold

Study: Breastfeeding Mothers Do Not Pass Tacrolimus On To Babies.

Medwire Share to FacebookShare to Twitter (1/29) reports that a study Share to FacebookShare to Twitter published in the Clinical Journal of the American Society of Nephrology found that "breastfeeding mothers taking tacrolimus do not pass the immunosuppressant on to their babies when breastfeeding." Researchers said that "the good news for breastfeeding mothers is that ingestion of tacrolimus by infants via breast milk is 'negligible.'"

FDA approves OTC overactive-bladder treatment.

Reuters (1/26, Berkrot) reported that the US Food and Drug Administration on Friday announced it has approved an over-the-counter version of Merck's Oxytrol (oxybutynin) as a treatment for overactive bladder in women ages 18 years and older. The agency noted that findings from nine trials involving 5,000 study participants, showed that consumers readily understand information on the drug-product's labeling and that they are able to use oxybutynin appropriately. The Whitehouse Station, New Jersey-based pharmaceutical company said it expects to launch the OTC version on the market in the fall. However, the FDA said that for men with overactive bladder, only the prescription version of Oxytrol will be available.
        According to MedPage Today (1/26, Gever), Merck "did not seek OTC status for the product in men." The nine studies showed that men were "relatively poor at correctly determining whether oxybutynin was the appropriate treatment for their urination problems. A key worry is that incorrect self-diagnosis in men could delay detection of prostate cancer."
        The Triangle Business Journal (1/26, Ohnesorge, Subscription Publication) noted that the FDA's approval made Oxytrol the first, overactive bladder treatment in the anticholinergics class to become available OTC. Oxytrol is a "patch applied to the skin every four days."
        WebMD (1/26, Doheny) also covered the story, noting that according to Merck, "more than 20 million American women" have overactive bladders.

FDA panel begins hearing on hydrocodone.

ABC World News (1/24, story 5, 2:15, Sawyer, 7.43M) reported, "Now, to the crackdown on the epidemic use of prescription pain killers in America. Consider this, the US, just 4.5% of the world's population, consumes 99% of the world's hydrocodone." ABC (Kerley) added, "The Drug Enforcement Administration can't win the battle, and is pleading to make it harder" to get prescription drugs containing hydrocodone. Special Agent Robert Hill of the DEA Pharmaceutical Investigations Section was shown saying, "If it [hydrocodone] has more restrictive manners tied to it, it could help reduce the abuse potential." Kerley added that there is some concern that if hydrocodone is "classified as a more dangerous drug, that could drive up costs" for drug makers and healthcare providers, and patients "would have to make more visits to the doctor for refills, spending more in co-pays."
        Bloomberg News (1/25, Edney) reports that an FDA advisory panel began its two-day meeting Thursday to contemplate the DEA's request that the agency consider tightening prescribing and other rules on hydrocodone drug products. For one, the Drug Safety and Risk Management Advisory Committee is "debating the DEA's request to limit prescriptions of hydrocodone combination pills and cough suppressants to a 90-day supply instead of the current five refills within six months. The proposal also would strip physician assistants and nurse practitioners of their authority to prescribe the products." In addition, the DEA has asked the agency to move hydrocodone-combination products - such as Vicodin (acetaminophen and hydrocodone) - from the schedule III designation to the highly regulated schedule II class under which narcotics - such as OxyContin (oxycodone) and pure hydrocodone - fall.
        HealthDay (1/25, Gardner) notes that advocates of a "move to Schedule II status point to tragic deaths and suicides that have been the result of misuse of these prescription drugs" whereas opponents have expressed concern "that tightening access to the drugs would mean that people who really need them to ease pain will not be able to get them." Meanwhile, an FDA spokesperson "said the advisory panel would most likely vote on the issue Friday afternoon."

FDA Advisory Panel Recommends New Restrictions On Hydrocodone Products.

An FDA advisory panel's recommendation regarding hydrocodone restrictions received a substantial amount of coverage in print, online, and on two of last night's national news broadcasts. Some sources pointed out that the FDA was likely to adopt the recommendations. Additionally, many sources pointed out that the recommendations did face some criticism, particularly from pain patient advocacy groups.
        The CBS Evening News (1/25, story 9, 0:15, Pelley) reported that "an FDA advisory panel" has "recommended new restrictions on prescriptions and refills" of products containing hydrocodone.
        ABC World News (1/25, story 8, 0:30, Sawyer) reported, "The FDA is expected to follow the recommendation making it more difficult to get those drugs prescribed because of all the abuse."
        The Los Angeles Times Share to FacebookShare to Twitter (1/26, Girion) reported that the panel "recommended Friday that the agency reclassify a Schedule II narcotic, placing it in the same category as other widely abused medications, including OxyContin and fentanyl." Should the agency approve "the change, patients would be able to get fewer hydrocodone pills at one time, and there would be more restrictions on refills. In addition, pharmacies would have to follow stricter procedures for handling and storing the drug."
        The New York Times Share to FacebookShare to Twitter (1/26, Tavernise, Subscription Publication) reported, however, that "at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse." Still, the Times points out that "the drug agency is likely to follow" the recommendation.
        The AP Share to FacebookShare to Twitter (1/25) reported, "FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them." Douglas Throckmorton, the agency's deputy director for regulatory programs, said, "There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society."

CDC: New strain of norovirus has reached US.

National media outlets, including some major dailies, as well as health-related sources offer notable coverage of this week's Morbidity and Mortality Weekly Report from the CDC that revealed a new strain of norovirus has reached the US from Australia. Nearly all reports noted how the CDC credited the new strain for 141, or 58%, of the 266 norovirus outbreaks reported since September, with many sources describing the norovirus as a highly contagious "bug."
        For example, USA Today (1/24, Weise, 1.71M) says that, according to the CDC report, "Last month, the bug, which causes nausea, forceful vomiting, diarrhea and abdominal pain, accounted for 58% of outbreaks of norovirus nationally." CDC epidemiologist Aron Hall said "it's not clear whether this strain is more likely to infect people or make them more ill than previous strains, but...any time a new strain emerges, it has the potential to increase disease 'because people haven't been exposed to it before, so they're more susceptible.'" He said this year's norovirus season, which normally peaks in January, "unfortunately coincides with an early increase in flu season," adding that, besides timing, there was no link between the norovirus and the stomach flu.
        The Washington Post (1/25, Brown, 489K) adds, "About two-thirds of this season's outbreaks occurred in long-term care institutions and 13 percent involved restaurants," according to the Morbidity and Mortality Weekly Report. For its part, Virginia "has identified six outbreaks caused by GII.4 Sydney this season - four in 2012 and two this month, said Michelle Stoll, a spokeswoman for the state health department. ... Information about outbreaks in Maryland and the District caused by the new strain was not immediately available."
        The AP (1/25, Stobbe) cites Ian Goodfellow, a prominent researcher at England's University of Cambridge who "calls norovirus 'the Ferrari of viruses' for the speed at which it passes through a large group of people. 'It can sweep through an environment very, very quickly."
        CQ (1/25, Subscription Publication) quotes Aron Hall in a news release, "The new strain spread rapidly across the United States from September to December 2012. The proportion of reported outbreaks caused by this strain increased dramatically from 19 percent in September to 58 percent in December." The CDC "says the 2009 launch of CaliciNet was a 'milestone' in monitoring norovirus that permitted 'identification of new strains in real time.'" In this connection, the Milwaukee Journal Sentinel (1/25, Herzog, 221K) notes the lab at the Milwaukee Health Department is connected to CaliciNet.
        Dubbing the new strain "a highly contagious gut bug," the NBC News (1/25, Aleccia) in its "Vitals" blog adds that CDC officials "advised health workers to be vigilant for increases in norovirus outbreaks this winter because of the new GII.4 Sydney strain. They should follow standard infection control practices to prevent norovirus. In addition, the general public ought to be aware that the new bug is out there and take precautions including washing hands with soap and water, disinfecting surfaces, rinsing fruits and vegetables, cooking shellfish thoroughly and not preparing food or caring for others while ill."
        The Louisville (KY) Courier-Journal (1/25, Ungar, 150K) adds many local physicians "say they've seen a spike in gastroenteritis cases in recent months that may be related. The emergency room at Sts. Mary and Elizabeth Hospital, for example reported 66 cases between late November and early December, and in the past week saw nine cases of vomiting or gastroenteritis, seven cases of diarrhea and 14 cases of gastroenteritis."
        Further coverage of the CDC's Morbidity and Mortality Weekly Report can be found in reports from HealthDay (1/25, Preidt),Medscape (1/25, Lowes), WebMD (1/25, Boyles), and Modern Healthcare (1/25, Barr, Subscription Publication, 71K).

Blacks, Hispanics With Hypertension May Not Receive Adequate Diuretic Treatment.

MedPage Today Share to FacebookShare to Twitter (1/25, Kaiser) reports, "Blacks and Hispanics who are hypertensive may not be receiving adequate diuretic treatment," according to two studies published in the American Journal of Hypertension. "In the first study Share to FacebookShare to Twitter (PDF), which included black patients with uncontrolled hypertension, only 46% of them were prescribed a diuretic, according to Linda M. Gerber, PhD, of Weill Cornell Medical College in New York City, and colleagues." Meanwhile, "in the second study Share to FacebookShare to Twitter (PDF), blacks, Hispanics, and other ethnic minority patients with hypertension and on dialysis were about 25% less likely to have 'exposure' to each of four common classes of blood pressure medications such as beta-blockers and calcium-channel blockers compared with whites, reported Theresa I. Shireman, PhD, of the University of Kansas School of Medicine in Kansas City, Kans., and colleagues."

Researchers Say They Have Used Stem Cells To Grow Human Kidney Tissue.

AFP-Relaxnews Share to FacebookShare to Twitter (1/25) reports, "Researchers in Japan said Wednesday they have succeeded in growing human kidney tissue from stem cells for the first time in a potential breakthrough for millions with damaged organs who are dependent on dialysis." One of the researchers, "Kenji Osafune of Kyoto University, said his team had managed to take stem cells...and nudge them specifically in the direction of kidney tissue." He "said they had succeeded in generating intermediate mesoderm tissue from the stem cells, a middle point between the blank slate and the finished kidney tissue."