Wednesday, March 27, 2013

DEA calls for stricter regulation of painkillers.

The Los Angeles Times (3/27, Girion, Glover, 692K) reports that, in a letter to the Food and Drug Adminstration, Joseph T. Rannazzisi, who heads the Drug Enforcement Administration's Office of Diversion Control, called for "federal regulators to impose tougher rules on the way pharmaceutical companies market narcotic painkillers to physicians, noting that such drugs are involved in more than twice as many deaths as heroin and cocaine combined." Rannazzisi urged the FDA "to adopt stricter limits on OxyContin, Vicodin and similar medications to 'safeguard the American public.'" Noting that "Rannazzisi sent his letter in support of a petition asking the FDA to rein in the use and misuse of the addictive drugs," the Times adds that "his endorsement came as a welcome surprise to advocates of the effort."
        The Milwaukee Journal Sentinel (3/27, Fauber, 221K) reports that Rannazzisi's letter is "the latest development in the complicated and contentious issue of how opioids are prescribed and marketed in America." The Journal Sentinel notes that, "if such a change were approved, it would make it more difficult for drug companies to market the drugs for chronic, noncancer pain." In addition to the labeling change, the Journal Sentinel notes that "the DEA and others also have sought tighter restrictions on opioid prescribing by asking the FDA to change the way opioids containing hydrocodone are categorized, what is known as a scheduling change."
        The Hill (3/27, Wilson, 21K) also reports on the story on its "Regwatch" blog.
        Schumer calls on FDA to require abuse deterrent technology on generic oxycodone. On its "Floor Action" blog, The Hill (3/27, Cox, 21K) reports that Sen. Charles Schumer (D-NY) "urged the Food and Drug Administration (FDA) to require security features on generic versions of the addictive painkiller, Oxycodone." Although "Oxycodone will lose its patent protection" next month, the Hill notes that "the FDA has not required generic drug manufactures to include security measures used in Oxycodone to make it more difficult to abuse the drug through crushing and snorting the medication." Schumer "called on the FDA to specify which abuse deterrent technology is most effective and tell all pharmaceutical companies to use that standard."

Dexmedetomidine associated with improved outcomes after cardiac surgery

Patients who receive dexmedetomidine after cardiac surgery may have lower postoperative rates of mortality as well as complications, according to a new study.
Researchers performed a retrospective cohort study at a single medical center to examine whether patients who received dexmedetomidine after coronary artery bypass grafting (CABG) alone or CABG plus valvular or other procedures had better rates of postoperative complications and mortality.
The study's primary outcome measures were mortality and postoperative major adverse cardiocerebral events, including stroke, coma, perioperative myocardial infarction, heart block or cardiac arrest. Secondary outcomes were renal failure, sepsis, delirium, postoperative hours spent on a ventilator, length of hospital stay and 30-day readmission rates. The study results were publishedonline March 19 by Circulation.
Overall, 1,134 patients were included in the study, 568 who received intravenous dexmedetomidine infusion and 566 who did not. Approximately 71% of patients were men, and most (67.6%) were white. Those in the dexmedetomidine group had significantly lower mortality rates in the hospital postsurgery (1.23% vs. 4.59%; adjusted odds ratio, 0.34; P<0.0001), at 30 days (1.76% vs. 5.12%; adjusted odds ratio, 0.39; P<0.0001), and at one year (3.17% vs. 7.95%; adjusted odds ratio, 0.47; P=0.0002). Risk for overall complications (47.18% vs. 54.06%; adjusted odds ratio, 0.80; P=0.0136) and delirium (5.46% vs. 7.42%; adjusted odds ratio, 0.53; P=0.0030) was also lower in the dexmedetomidine group.
The authors noted that their study was limited by its observational cohort design and its use of data from a voluntary database, among other factors. However, they concluded that perioperative use of dexmedetomidine was associated with lower postoperative mortality for up to one year, as well as lower rates of all postoperative complications and delirium in patients undergoing cardiac surgery. They called for additional multicenter randomized trials to confirm their findings.

Phosphorus Levels in Individuals with Normal Kidney Function Linked with Kidney Failure Risk.

In a group of nearly 95,000 ethnically diverse individuals without kidney disease, every 0.5-mg/dL increase in phosphorus was linked with a 40% increased risk of developing ESRD over an 11-year period. Compared with individuals with the lowest phosphorus levels (1.9–3.0 mg/dL), those with the highest levels (3.9–5.7 mg/dL) had a 48% increased risk of developing ESRD. The findings are published in a recent American Journal of Medicinestudy

"Hygiene hypothesis" suggests hypercleanliness causing more sickness.

The Washington Post (3/26, Telis, 489K) reports, "A growing body of evidence suggests that all the antibacterial-wiping, germ-killing cleanliness of the developed world may actually be making us more prone to getting sick - and that a little more dirt might help us stay healthier in the long run." The "hygiene hypothesis" idea "has been cited as a possible explanation for everything from multiple sclerosis to hay fever and autism." Michael Zasloff, an immunologist and physician at MedStar Georgetown University Hospital, commented, "Bacteria, fungi, lots of these things we think of as bad - they're all part of our environment, and we evolved to live with them." He explained that "through exposure to these microbes early in life, your immune system learns what's harmful and what isn't...and that readies the immune responses you'll have for the rest of your life."

FDA warns PPD found in black henna tattoos can cause allergic reactions.

There were several reports Monday in national publications concerning a Food and Drug Administration announcement about the dangers of a chemical found in black henna tattoos that could lead to allergic reactions. Many of the articles stressed that the allergen was not located in natural henna tattoos.
        The Los Angeles Times (3/25, Brown, 692K) "Booster Shots" health blog reports the FDA announced that temporary henna tattoos "may leave a longer-lasting physical effect" because "hair dye including p-phenylenediamine" (PPD) found in "longer-lasting 'black henna' tattoos" can trigger allergic reactions, which can cause "redness, blisters, oozing lesions, increased sensitivity to sunlight and permanent scarring." The Times explains henna "is a reddish-brown pigment that comes from the flowering plant Lawsonia inermis" that people have used as a "cosmetic and a dye for hair and fabrics for thousands of years. But so-called black henna, often used in tourist destinations and other specialty shops, is a different product and may not include natural henna at all." The PPD allergies were noted in a recent study published in the Journal of the German Society of Dermatology.
        The New York Daily News (3/26, Miller, 543K) reports the FDA claims the allergic reactions "occur immediately after receiving the treatment or as long as 2-3 weeks later, and have landed people in emergency rooms." Dr. Neil Sadick, "a professor of clinical dermatology at Weill Cornell Medical College with a private practice in Manhattan, says he has treated several patients for black henna reactions in recent years." Sadick said, "People can contact dermatitis from the henna in the tattoo. They can get weeping blisters, or another allergic reaction."
        NBC News (3/25, Dahl) reports on its website that the "photos of reactions to the black henna can be striking." For example, the FDA posted an "image of a group of friends showing off their temporary tattoos - the littlest hand in the group is that of a 5-year-old girl, whose skin severely reddened where the tattoo was applied. And in 2008, we wrote about a New England Journal of Medicine case study describing a 19-year-old woman whose skin bubbled up over the swirly tattoo pattern after she got a black henna tattoo at a wedding."
        The Boston Globe (3/25, Kotz, 250K) "Daily Dose" health blog reports PPD has been "banned in skin cosmetics, it's still cropping up in temporary tattoos applied at local beaches and foreign resorts. Massachusetts has a number of temporary tattoo artists, who advertise their services online for weddings and other special events, and it's best to ask them if they use black hair dye in their products; some airbrush them on with skin paints." The Massachusetts Department of Public Health "regulates tattoo parlors that provide permanent tattoos, but kiosks offering temporary ones."

Infections may be associated with cognitive problems.

The Los Angeles Times (3/26, Healy, 692K) "Booster Shots" blog reports, "Scientists have long suspected that infections wreak havoc not just on the body but on the mind as well, and it doesn't seem to matter whether the infections are viral or bacterial, or what part of the body they affect. Having a medical history that includes more than the usual infections puts a patient at higher risk of stroke and vascular disease." In turn, "poorer vascular health has been linked to Alzheimer's disease and other dementia risk."
        The Huffington Post (3/26) reports that a study published March 26 in the journal Neurology "shows an association between having higher infection levels in the blood and risk of cognitive problems."
        Forbes (3/25, DiSalvo, 928K) reports, "Researchers tested thinking and memory in 1,625 people with an average age of 69 from northern Manhattan in New York. Participants gave blood samples that were tested for five common low grade infections: three viruses (herpes simplex type 1 (oral) and type 2 (genital), and cytomegalovirus), chlamydia pneumoniae (a common respiratory infection) and Helicobacter pylori (a bacteria found in the stomach)." The study found that "the people who had higher levels of infection had a 25 percent increase in the risk of a low score on a common test of cognition called the Mini-Mental State Examination."
        The NBC News (3/26, James) "Vitals" blog reports that study author Dr. Mira Katan, of Columbia University in New York City, said, "While this association needs to be further studied, the results could lead to ways to identify people at risk of cognitive impairment and eventually lower that risk." Katan also "said she found the link between infections and memory loss was greater among women, people with lower levels of education and most prominently, in people who do not exercise."
        HealthDay (3/26, Norton) reports, "Katan said that infection with the viruses, rather than the two bacteria, seemed to play a greater role in mental decline. Overall, 23 percent of the study participants had signs of mental impairment at the study's start; the odds of impairment were 2.5 times higher among people who carried all three viruses - HSV 1 and 2, and cytomegalovirus - than for people who carried only one virus."
        MedPage Today (3/26, Gever) reports that "an accompanying editorial...suggested that the associations were strong enough to warrant a clinical trial of an antiviral drug. Timo Strandberg, MD, PhD, of the University of Helsinki in Finland, and Allison Aiello, PhD, MS, of the University of Michigan in Ann Arbor, noted that similar associations had been found between viral exposure and schizophrenia, and a course of valacyclovir (Valtrex) had shown 'a favorable effect.'" The editorialists "acknowledged that such a study in older patients with preexisting cognitive impairment would be more challenging and could fail entirely, since 'comorbid factors in older patients or the advanced nature of the dementia might overwhelm any effect of the intervention,' they wrote."

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 about using 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.

Energy drinks may boost blood pressure, lead to erratic heartbeat.

Bloomberg News (3/22, Ostrow) reports, "Energy drinks, which have been linked to deaths and hospitalizations, may boost blood pressure and lead to an erratic heartbeat," according to a study presented at an American Heart Association meeting. Investigators looked at data from seven studies.
        HealthDay (3/22, Dotinga) reports that, among the studies, "a total of 93 participants drank energy drinks and had their "QT interval" measured, while another 132 underwent blood pressure measurement. In most of the studies, the participants - aged 18 to 45 - drank one to three cans of Red Bull."
        Heartwire (3/22) reports that "subjects had increased systolic blood pressure and, more troubling, they also had, on average, a 10-msec prolongation in their QT interval." Study leader Dr Sachin Shah told Heartwire, "The blood-pressure finding falls in line with what we would suspect because of the caffeine content," but the finding on QT prolongation is "a bit of a wake-up call for us investigators to start studying it a bit more thoroughly, and it needs to happen sooner rather than later."

FDA warns consumers supplements may contain hidden medications.

FOX News (3/21, Rowan) reports, "The Food and Drug Administration is warning consumers Thursday that several supplements advertised as sexual enhancements contain hidden drugs." Specifically, "'Stiff Days' contains sildenafil, the active ingredient in prescription drug Viagra," while "'Rock-It Man' contains a similar compound called hydroxythiohomosildenafil; and 'Libido Sexual Enhancer' contains both of those ingredients as well as tadalafil, which is the active ingredient in the prescription drug Cialis." The agency warns that the "undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels." Broadly, the FDA warns consumers that many supplements "have potentially harmful hidden ingredients."
        NBC News (3/21, Fox) reports, "Three 'male enhancement' products being sold online say they're all herbal, but they contain hidden prescription drug ingredients and could be dangerous, the Food and Drug Administration said on Thursday." So "while they are marketed as alternatives to the prescription drugs to be used without the guidance of a doctor, they are in fact virtual copies, without any oversight to ensure they are safe." And "anyone who has bought any of the products should just toss them, the FDA advises."

Study: One in ten US deaths linked to overconsumption of salt.

NBC Nightly News (3/21, story 6, 0:35, Williams, 7.86M) reported, "The same Harvard researchers who told us just yesterday about the high number of deaths linked to drinking too many sugary drinks said today one in ten deaths in this country can now be linked to overconsumption of salt."
        The ABC News (3/21, Moisse) "Medical Unit" blog reports that investigators "used data from 247 surveys on sodium intake and 107 clinical trials that measured how salt affects blood pressure, and how blood pressure contributes to cardiovascular disease like heart attacks and stroke."
        Bloomberg News (3/22, Armour) reports that the researchers found that "eating too much salt contributed to 2.3 million heart-related deaths worldwide in 2010, and 40 percent of those deaths were premature." Almost "1 million of the deaths, or 40 percent of the total, happened in people who were 69 years old or younger, according to the study." Bloomberg News pointed out that "The U.S. ranked 19th of the 30 largest countries studied for deaths due to excess salt." The research was presented at an American Heart Association meeting.
        The Huffington Post (3/21) reports that a separate study, also "presented at a meeting of the American Heart Association, shows that 75 percent of people around the world consume significantly more salt every day than is recommended." Researchers looked at data from "187 countries, and 247 separate surveys on salt intake between 1990 and 2010 through the Global Burden of Diseases Study." The investigators found that "people around the world ate nearly 4,000 milligrams of salt a day in 2010, which is nearly twice as much as is recommended by the World Health Organization (less than 2,000 milligrams of salt a day) and nearly three times as much as is recommended by the American Heart Association (less than 1,500 milligrams of salt a day)."
        MedPage Today (3/22, Phend) reports, "Only six nations didn't shake out with an average sodium intake exceeding the WHO limit of 2,000 mg a day; only Kenya had a national average that would meet the AHA threshold of 1,500 mg per day." HealthDay (3/22, Preidt) and the Daily Mail (UK) (3/22, Nye) also cover the first study.
        Study: Pre-packaged foods for toddlers have too much sodium. The CNN (3/21) "The Chart" blog reports, "Most packaged meals and snacks marketed to toddlers have more than the recommended amount of sodium per serving, meaning children as young as one are most likely eating far too much salt early in life, according to" research presented at an American Heart Association meeting. These "findings were alarming to researchers since there is evidence a child's sodium intake is related to the likelihood that he or she will develop hypertension as an adult." A research team led by Joyce Maalouf, a fellow at the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention, looked at "more than 1,100 products specifically marketed to babies and toddlers that were sold in grocery stores." The researchers considered a product to be high in sodium if a serving contained more than 210 milligrams of sodium.
        CBS News (3/22, Jaslow) reports on its website that the researchers found that "75 percent of" the "pre-packaged meals and savory snacks for toddlers were high in sodium." The researchers also "found toddler meals on average had significantly more sodium than baby meals, with some as high as 630 milligrams per serving." According to Maalouf, "Our concern is the possible long-term health risks of introducing high levels of sodium in a child's diet, because high blood pressure, as well as a preference for salty foods may develop early in life." Maalouf added, "The less sodium in an infant's or toddler's diet, the less he or she may want it when older."
        The Huffington Post (3/21, Pearson) reports, "Maalouf stressed that even within specific categories or brands of toddler meals, sodium content can range. 'Therefore, it is important for parent and caregivers to read nutrition facts and labels and choose products with the lowest amount of sodium,' she said."
        HealthDay (3/22, Doheny) reports, "The message for parents, Maalouf said, is to read nutrition labels and choose lower-sodium items."

Low Serum Bicarbonate May Accelerate Kidney Disease Progression.

Low serum bicarbonate levels increased the risk of kidney disease progression, particularly for individuals with preserved kidney function, in an AJKD study of 3939 patients with CKD stages 2 to 4 who were followed for an average of 3.9 years. The risk of developing ESRD or a 50% reduction in kidney function was 3% lower per 1-mEq/L increase in serum bicarbonate level. Risk was higher for participants with eGFR above 45 mL/min/1.73 m2. The risk of heart failure increased by 14% per 1-mEq/L increase in serum bicarbonate level over 24 mEq/L.

Suboptimal Kidney Response to FGF-23 May Increase Risks for CKD Patients.

Among patients with CKD and cardiovascular disease, those with above-average levels of the hormone FGF-23 but below-average levels of urinary phosphorus had the highest risks of both premature death and cardiovascular events. Findings from a recent JASN study of 872 patients indicate that urinary phosphorus excretion significantly modifies FGF-23's links with premature death and heart disease. In patients with low urinary phosphorus levels, the kidney's response to FGF-23 may be suboptimal, and the relative resistance to the hormonal actions of FGF-23 in the kidney may identify novel aspects of kidney dysfunction.

Study highlights difficulty in identifying patients who did not need to visit ED.

NPR (3/19, Shute) reports in its "Shots" blog on a study published in the Journal of the American Medical Association finding that while "cash-strapped states are coming up with an appealingly simple fix for soaring Medicaid costs: Don't pay for emergency room visits for people who aren't sick enough to be there." The problem is that "it's almost impossible to figure out who's sick enough and who isn't at the moment they walk in the door." The study was based on "discharge records for almost 35,000 people who visited emergency rooms in 2009."
        Modern Healthcare (3/21, Robeznieks, Subscription Publication, 71K) reports, "Based on 'discharge diagnosis' (the physician's assessment of a patient's condition upon release), only 6.3% of the cases studied could be classified as 'primary-care treatable visits.'"

CVS employees required to have weight, body fat, glucose screenings.

NBC Nightly News (3/20, story 6, 2:40, Williams, 7.86M) reported that "one of the nation's big employers, the CVS drugstore chain, is taking a hard line on monitoring its own employees' weight." NBC (Gosk) added, "To take part in the company-sponsored health insurance, CVS employees are now required to have their weight, body fat and glucose levels screened by their doctors. If they do not, their premiums may go up $600 a year." CVS says that the "goal is to help employees 'improve their health and manage health-associated costs.'"
        ABC World News (3/20, story 5, 2:05, Osunami, 7.43M) reported, "Body weight, blood pressure, blood sugar and cholesterol – those are the numbers that matter. And according to company documents, if they aren't good, workers have a year to make them better, or you may have fewer health options to choose from the next time you enroll." CVS "says it's not alone or strange, saying that most employers today offer their workers health assessments and then hand out incentives to the workers who complete them. But concerned employees tell us this isn't the carrot and feels more like the stick."
        The Boston Herald (3/21, McConville, 91K) reports, "It's a choice most working Americans eventually will have to make, experts say: Tell your insurance company how much you weigh, and how much fat you're carrying, or pay a lot more for your medical coverage." CVS spokesman Michael D'Angelis said that "CVS took the approach because it works."
        The Los Angeles Times (3/20, Hamilton, 692K) reports, "Employees must agree to sign a form claiming the screening is voluntary...and allow the insurer to pass the results to the firm handling its health program."
        The Washington Times (3/21, Chasmar, 76K) reports that the plan "is causing outrage among employees for asking workers to 'voluntarily' give medical information or face a $600 fine."
        The Huffington Post (3/20) reports, "The health care reform law allows employers to levy a higher penalty against workers who don't participate in company wellness programs."
        The New York Daily News (3/21, Edelman, 543K) reports, "Employees have until May 1 to submit to the company-sponsored wellness review." Also, employees "must either be tobacco-free by May 1, 2014 or participate in the WebMD tobacco cessation program." The plans are said to have "immediately raised red flags among patient privacy advocates."
        ABC News (3/20, Osunsami) reports in its "Medical Unit" blog, "Critics are calling the policy coercion, and worrying that CVS or any other company might start firing sick workers." But "CVS insists that the use of health screenings by employer-sponsored health plans is a common practice."
        NBC Today Show (3/20, Langfield, 4.65M) reports, "While many employers have been pushing its workers to get healthier, it's usually through incentives rather than penalties. 'This is about as coercive and blunt as I've ever seen,' said Dr. Deborah C. Peel, the founder of Patient Privacy Rights, a nonprofit organization based in Austin, Texas." But CVS "said the company would never see the test results."

High Potency Statins Linked with Acute Kidney Injury.

Patients without CKD who took high-potency statins for high blood pressure had a 34% higher risk of being hospitalized for acute kidney injury (AKI) within 120 days after starting treatment than those taking low-potency statins in a recent BMJ study. The observational study compared patients who were prescribed high-potency statins to those who were prescribed low-potency statins in seven Canadian provinces and two databases in England and the United States between 1997 and 2008. The study included more than 2 million patients. Each person hospitalized for AKI was matched with 10 controls.

Many in Asia and India Exposed to Kidney Risks of Herbal Medicines.

Many cases of aristolochic acid nephropathy (AAN) – a kidney disease caused by the intake of a botanical compound containing aristolochic acid – may be undiagnosed or misdiagnosed. The compound is banned in the US but is used in herbal medicines in Asia and India and is readily available to Westerners via the Internet. Scientists reviewed worldwide cases of AAN, which is linked with renal failure and urothelial cancer, in an Annals of Internal Medicine study. They found that many millions of people continue to be at risk. The researchers also suggested a new classification system and treatment guidelines for AAN.

Physicians, health experts urge FDA to restrict caffeine in energy drinks.

The New York Times (3/20, Meier, Subscription Publication, 1.68M) reported, "A group of 18 doctors, researchers and public health experts" in a letter (pdf) sent Tuesday to FDA Commissioner Dr. Margaret A. Hamburg, "argued that energy drink makers had failed to meet the regulatory burden placed on them to show that the ingredients used in their beverages were safe," especially for use by children. Therefore, the group urged the agency to "restrict caffeine content in the products and to require manufacturers to include caffeine content on product labels." The Times notes that energy-drink makers "have insisted their products are safe" and the FDA has "said that it is safe for adults to consume about 400 milligrams of caffeine daily, though many experts say that most adults can consume 600 milligrams or more of caffeine without ill effect."
        The San Francisco Chronicle (3/20, Coté, 220K) "City Insider" blog adds that San Francisco City Attorney Dennis J. Herrera joined the physician's group Tuesday in calling for the FDA to "regulate caffeine levels in energy drinks, saying the beverages pose health risks, particularly for youths." Herrera is "investigating the Corona (Riverside County)-based maker of Monster Energy drinks under the state's unfair competition law, targeting its marketing claims that the amount of caffeine in its products is 'completely safe.'" Notably, under the "current FDA standards, caffeine in sodas can register no higher than about 71 milligrams per 12-oz. serving" but energy drinks "often have between 100 and 300 milligrams of caffeine per 8-oz. serving and are often sold in much larger quantities per can, according to the doctors' letter."
        Meanwhile, Bloomberg News (3/20, Edney) points out that the FDA "said in November it's employing the help of outside advisers in a review of the caffeinated drinks. Based on the review, the agency may move to regulate the products' use or labeling. The FDA said it will also look into whether the ingredients in addition to caffeine are safe." However, the FDA previously, "said it hadn't seen problems with two main additives, taurine and guarana."
        Energy drinks changing aisles to avoid Federal regs. In a front-page story, the New York Times (3/20, A1, Meier, Subscription Publication, 1.68M) reports, "Fans of Monster Energy, the popular high-caffeine energy drink, may not notice the change: its ingredients will be the same and its familiar label bearing a green, clawlike monogram will change only slightly. But the drink's maker has decided after a decade of selling it as a dietary supplement to market it as a beverage, a switch that will bring significant changes in how it is regulated." For one, the move from the supplement aisle to the beverage aisle in the grocery store means Monster Beverage "will no longer be required to tell federal regulators about reports potentially linking its products to deaths and injuries." Monster's move "follows a similar regulatory makeover by another brand, Rockstar Energy," and comes "amid intensifying scrutiny of energy drink safety."

Supreme Court hears key case on generic drug-maker's liability.

The Supreme Court heard arguments on Tuesday in a closely watched case that could decide the legal liability of generic drug manufacturers for drug design flaws even though the company did not actually design the drug. Print and broadcast coverage of the arguments was substantial, with more than four-and-a-half minutes of coverage on the network newscasts.
        ABC World News (3/19, story 4, 1:50, Sawyer, 7.43M) reported, "We learned today that for the first time in half a century, Americans are spending less on prescription drugs. A small drop due in part to have the switch away from brand names toward cheaper generic pills. Tonight, more than 80% of all prescriptions are generic drugs. But one patient has taken her story all the way to the Supreme Court."
        The CBS Evening News (3/19, story 7, 2:45, Schieffer, 5.58M) recounted the story behind the case, noting that in 2004 Karen Bartlett, "suffering shoulder pain, took an anti-inflammatory drug known by its generic name as Sulindac and suffered a reaction so severe her life, as she knew it, was over," and " legally blind and needs near constant assistance." CBS added, "Bartlett sued the manufacturer of the generic drug, Mutual Pharmaceutical, and a jury awarded her $21 million." However, "at the Supreme Court...the company's lawyer, Jay Lefkowitz, argued it can't be held responsible since by law it was merely copying a brand name drug." The Washington Post (3/19, Barnes, 489K) quotes Lefkowitz as saying, "Federa; law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version."
        In fact, the AP (3/20, Holland) reports, the court "seemed skeptical" of "allowing generic drug manufacturers to be sued in state court for a drug's design defects if federal officials approved the brand-name version the generic drug copied." The AP continues,"To allow Bartlett's verdict to stand would cause a conflict between state liability law and federal law requiring the two drugs to be the same," Lefkowitz said. "What we are trying to do is preserve the FDA's role here, not have juries second-guess on a case-by-case and state-by-state basis imposing different safety obligations on manufacturers when Congress has established a regime for FDA to control this,' said Anthony Yang of the solicitor general's office."
        The Los Angeles Times (3/20, Savage, 692K) reports that Justices Antonin Scalia and Stephen Breyer "questioned whether juries of ordinary citizens are qualified to decide whether a drug's benefits outweigh its risks. A lawyer for the drug maker and one for the Obama administration urged the court to throw out the verdict and rule that juries cannot decide an approved drug is too dangerous to be on the market. But Justices Sonia Sotomayor and Elena Kagan appeared to disagree," suggesting "the FDA's approval of a drug meant only that it could be sold," but "did not necessarily prevent a jury from finding it was unreasonably dangerous."
        The Wall Street Journal (3/20, Bravin, Subscription Publication, 2.29M) reports that previous court rulings have held that brand-name drug maker may be sued under state law for failing to provide adequate warning labels, but that in 2011, the court carved out an exception for generic drug makers because they are required to provide the same labels the FDA approves for branded versions of the drug. The Journal notes that some justices' questions suggested concern about denying Bartlett any remedy for her injuries.

Research links 180,000 deaths annually to sugary drinks.

Research linking the consumption of sugary drinks to thousands of deaths annually received a moderate amount of coverage online. Many sources point out that the impact was felt by both higher- and lower-income countries. Additionally, most of the articles discuss New York City Mayor Michael Bloomberg's recent attempt to ban large sugary drinks. USA Today (3/20, Winter, 1.71M) reports, "Researchers reported Tuesday that they have linked 180,000 obesity-related deaths worldwide to sugary drinks, including about 25,000 adult Americans." Investigators found that "1 in 100 deaths of obese people globally can be blamed on too many sweetened beverages, according to a study presented at an American Heart Association scientific conference in New Orleans." After analyzing "data collected as part of the World Health Organization's 2010 Global Burden of Diseases Study, the researchers determined that 78% of these deaths were in low- and middle-income countries."
        Bloomberg News (3/20, Armstrong) reports, "The beverages raised deaths worldwide from diabetes by 133,000, from cardiovascular disease by 44,000 and from cancer by 6,000, according to the study." The researchers found that "Latin America had the most diabetes deaths related to sugary drinks."
        The Huffington Post (3/20) reports that "heart deaths associated with sugary drink consumption were highest in East and Central Europe/Asia, with 11,000 deaths."
        CNN (3/20, Wade) reports, "In the United States, sugary drinks were linked to the deaths of 25,000 people from diabetes and other obesity-related diseases. As in many other countries, the death rates were highest in young adults under age 45, with one in 10 obesity-related deaths associated with sugary beverages."
        Forbes (3/20, 928K) reports that "the people with the least risk were people 65 and older in Japan: About 10 in a million people died from sugary drink-related causes."
        The ABC News (3/19, Moisse) "Medical Unit" blog reports that "Dr. Dariush Mozaffarian, senior author of the new study, said he now plans to study the effects of sugary drink regulation and taxation on health and health care costs." This "study comes one week after a judge blocked New York City Mayor Michael Bloomberg's proposed ban on supersized sodas, and one day after Mississippi Gov. Phil Bryant signed a bill preventing municipalities from setting limits on soda and salt content."
        MyHealthNewsDaily (3/20, Rettner) reports that according to study researcher Gitanjali M. Singh, "Our findings should push policy makers world-wide to make effective policies to reduce consumption of sugary beverages, such as taxation."
        Heartwire (3/20, Busko) reports that additionally, "the study reinforces the need for clinicians to encourage patients to drink fewer sugary beverages, Singh said." HealthDay (3/20, Norton) also covers the story.

Study: Less sleep linked to weight gain.

The New York Times (3/19, Parker-Pope, 1.68M) "Well" health blog reports sleep researchers from the University of Colorado found that "losing just a few hours of sleep a few nights in a row can lead to almost immediate weight gain." In an experiment, the researchers "found that staying up late and getting just five hours of sleep increased a person's metabolism," but "light sleepers ended up eating far more than those who got nine hours of sleep, and by the end of the first week" of the experiment, "the sleep-deprived subjects had gained an average of about two pounds." The blog explains "the researchers found that insufficient sleep changed the timing of a person's internal clock, and that in turn appeared to influence the changes in eating habits."

Small study reveals association between uncontrolled hypertension, Alzheimer's.

The Dallas Morning News (3/19, Churnin, 430K) reports that a new study "shows a link between uncontrolled hypertension and" Alzheimer's disease. Texas researchers conducted "a study of the aging brain in 147 healthy participants, ages 30-89, funded by the National Institute on Aging, measuring plaque and blood pressure at each visit. One of the most revealing findings showed that unmedicated, hypertensive adults who carried a genetic risk factor for Alzheimer's disease showed much higher plaque levels than all other groups." The study will appear in an upcoming issue of JAMA Neurology.

Report: One in three US adults dies with dementia.

USA Today (3/19, Lloyd, 1.71M) reports, "A new report showing one in three older adults dies with Alzheimer's disease and other forms of dementia is raising concerns about the disease's 'pervasive' scope and the spiraling costs of care," according to a report to be released March 18 by the Alzheimer's Association. The report found that "deaths from Alzheimer's and other forms of dementia have increased 68% from 2000 to 2010." USA Today adds, "The Alzheimer's numbers 'are simply staggering,' says Francis Collins, director of the National Institutes of Health, the federal agency overseeing research for 233 areas of disease."
        The New York Daily News (3/19, Evans, 543K) reports, "Records released Tuesday by the federal Centers for Disease Control show that the degenerative brain disease was the cause of death for 83,494 people in 2010 and was listed as a contributing factor for 26,488 additional people." Currently, "Alzheimer's is the sixth leading cause of death in the US, and the fifth leading cause of death in people over 65."
        The AP (3/19, Neergaard) reports, "Dying with Alzheimer's is not the same as dying from it. But even when dementia isn't the direct cause of death, it can be the final blow – speeding someone's decline by interfering with their care for heart disease, cancer or other serious illnesses. That's the assessment of the report." NPR (3/19, Hamilton) also covers the story on its "Shots" blog and "Morning Edition" program.
        Experts: Funding for Alzheimer's research hasn't caught up. Bloomberg News (3/19, Tirrell, Armstrong) reports, "The US in recent years has taken action to address a looming public health crisis tied to the aging of the Baby Boomers, the generation born from 1946 to 1964. While the National Alzheimer's Project Act was signed into law in January 2011 to coordinate efforts to treat and prevent Alzheimer's, funding hasn't caught up, advocates and researchers said." Neurology professor David Knopman, of the Mayo Clinic in Rochester, MN, stated, "Even before the sequester, the National Institute on Aging was only funding about one in 10 of the grants they received even though easily twice as many were meritorious." He added, "It might get worse now."

Task force finds insufficient evidence on peripheral artery disease test.

CQ (3/19, Norman, Subscription Publication) reports that, according to a draft recommendation issued by the US Preventive Services Task Force on Monday, "there's not enough evidence to judge the effectiveness of a particular blood pressure screening method that detects whether plaque has built up in the arteries, especially the legs." Noting that the recommendation "applies only to people who do not have symptoms of peripheral artery disease" or have been diagnosed with cardiovascular disease, CQ adds that, "for those without symptoms, task force members said in their draft that there's not enough scientific evidence right now to pass judgment on the benefits or harms of the blood pressure screening known as the ankle brachial index, or ABI."
        HealthDay (3/19) also reports on the story.

Potential Markers for Response to Sunitinib in Patients with Metastatic Renal Cell Carcinoma.

Markers such as CA9 and VEGFR1/2 in primary tumors might serve as predictors of a good response to sunitinib in patients with metastatic clear cell renal cell carcinoma, researchers reported at the 28th Annual European Association of Urology Congress. Among 20 patients, elevated vessel staining of VEGFR1/2 and increased microvessel density and CA9 staining in the primary tumor were observed in patients with a response to sunitinib. High CA9 protein expression was associated with longer overall survival.

Diabetes Prevention Program Generates Promising Results.

Participants in a 24-month lifestyle weight-loss program experienced greater decreases in fasting glucose (−4.35 mg/dL); insulin (−3.01 μU/mL); insulin resistance (−0.97); body weight (−4.19 kg); waist circumference (−3.23 cm); and BMI (−1.40) than participants receiving enhanced usual care. The program, which was based on the Diabetes Prevention Project and was led by community health workers, sought to induce weight loss that would be maintained through decreased caloric intake and increased physical activity. Enhanced usual care involved two visits with a registered dietitian and a monthly newsletter. The findings are published in theAmerican Journal of Preventive Medicine.

Scientists create device that could improve liver transplant procedure.

The Wall Street Journal (3/16, Whalen, Subscription Publication, 2.29M) reported that Oxford University scientists have created a device that can preserve a human liver outside the body for up to 24 hours. At present, most surgeons do not like to transplant livers that have been outside the body for more than 14 hours. The new device would allow livers to be transported over longer distances, and also give doctors more time in completing procedures.

Green Tea and Coffee Consumption Linked with Reduced Risks of Heart Disease and Stroke.

Higher green tea or coffee consumption reduced the risks of cardiovascular disease and stroke subtypes, especially intracerebral hemorrhage. Compared with seldom drinkers, people in a Stroke study who drank two to three cups per day had a 14% reduced risk of stroke, and those who drank four or more cups per day had a 20% reduced risk. Also, people who drank coffee three to six times per week had an 11% reduced risk of stroke, while those who drank coffee daily had a 19% to 20% reduced risk. The study included more than 82,000 middle-aged and older adults.

Saturday, March 16, 2013

Renal Cell Carcinoma Prevalence Higher in Dialysis Patients than in the General Population.

A recent study found that the prevalence of renal cell carcinoma was 0.5% during the past decade in adult patients with kidney failure. The annual incidence ranged from 0.3% to 0.8%. Most cancer cases were low grade and nearly 30% of them were detected incidentally by CT scans for unrelated reasons. The average time from dialysis initiation to cancer diagnosis was 3.4 years. The study of 6827 patients undergoing dialysis between 1999 and 2008 was presented at the 33rd Annual Dialysis Conference and its findings werereported by Renal & Urology News.

New Guideline on Hyperphosphatemia Management in Patients with Severe CKD.

United Kingdom's National Institute for Health and Clinical Excellence has published a new clinical guideline on hyperphospatemia management in patients with stages 4 and 5 CKD. It advises that a specialist renal dietitian should assess and give individualized information on managing dietary phosphate. For adults, calcium acetate should be offered as first-line treatment to control serum phosphate in addition to dietary management; for children, a calcium-based phosphate binder should be offered. At every routine clinical review, physicians should assess patients' serum phosphate control, taking into account dietary phosphate management, phosphate binder regimen, and treatment adherence.

First human cell transplant completed for a spinal cord injury.

The South Florida Sun-Sentinel (3/15, Lade, 155K) reports that following "decades of research," the Miami Project to Cure Paralysis announced it "completed its first human cell transplant for a spinal cord injury." The Sun-Sentinel explains doctors grew Schwann cells "from nerve tissue taken from an unidentified man's leg, then transplanted them back into his own body. The patient now has passed the critical 30-day, post-operation period without complications, giving researchers hope that they're headed toward curing paralysis and developing treatments for neurological conditions like Alzheimer's and Parkinson's disease." This was the first of eight scheduled procedures for the "project's groundbreaking clinical trial, approved by federal officials seven months ago," and the group is in search of six additional subjects who meet strict requirements.

FDA approves first lymph-node mapping drug in 30 years.

The AP (3/14) reports that the US Food and Drug Administration approved Navidea Biopharmaceuticals' "radioactive imaging agent" Lymphoseek (technetium Tc 99m tilmanocept), which is "intended to help determine if breast cancer or melanoma has spread to a patient's lymph nodes." The approval was based on data from two clinical trials, "involving 332 patients with breast cancer or melanoma," that tested the safety of the diagnostic imaging drug, as well its ability to map lymph nodes in comparison to "an older drug." In a statement, announcing the approval, the FDA noted that Lymphoseek is the "first new drug" approved for locating lymph nodes "in more than 30 years." In 1981, the agency approved "isosulfan blue" for lymph node mapping.
        The Columbus (OH) Business First (3/14, Ghose, 11K) notes that Dublin, Ohio-based Navidea, "which started as Neoprobe Corp., has gone through a long saga since licensing Lymphoseek in 2001, at first having the drug approval delayed because of issues with outside companies that make it. The drug will be sold and marketed through a revenue-sharing agreement by Dublin-based Cardinal Health Inc.," which manages the nation's "largest network of pharmacies that specialize in radioactive drugs."
        Medscape (3/14, Chustecka) adds that in the statement, Shaw Chen, MD, Deputy Director of the Office of Drug Evaluation IV in the FDA Center for Drug Evaluation and Research explained that to "use Lymphoseek, doctors inject the drug into the tumor area and then, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek's radioactivity." Medscape also points out that "results from the clinical trial supporting the approval were presented at the annual meeting of the American Society of Clinical Oncology in 2011, and reported at the time by Medscape Medical News."
        Diagnostic Imaging (3/14) reports that during the clinical trials, patients "were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes." Surgeons examined confirmed lymph nodes "for their content of blue dye and/or Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek, according to the FDA." Diagnostic Imaging adds that in 1974, the FDA also approved sulfur colloid for lymph-node mapping.

Relatives who observe dying patient's CPR may cope better.

The New York Times (3/14, A25, Belluck, Subscription Publication, 1.68M) reports a study published online on Wednesday in the New England Journal of Medicine found "family members who observed resuscitation efforts" of gravely ill patients "were significantly less likely to experience symptoms of post-traumatic stress, anxiety and depression than family members who did not." The results "applied regardless of whether the patient survived; most did not, since frequently patients in such dire condition cannot be saved." The study "also found that the presence of relatives did not affect the results of cardiopulmonary resuscitation, did not increase stress on physicians or other members of the medical teams, and did not result in legal claims."
        The Los Angeles Times (3/14, Kaplan, 692K) "Booster Shots" blog reports the researchers hypothesized "that a close-up view of the resuscitation efforts might 'help family members understand that everything possible to bring the patient back to life has been implemented." In the study, French doctors asked 570 relatives if they "wanted to watch the proceedings, and 79% said yes." The study found that "family members in the control group were 70% more likely to have PTSD 90 days later than those in the group that was invited to observe CPR." Additionally, the researchers claimed that family members who weren't present during CPR were more likely to have symptoms of anxiety and depression
        The NPR (3/14, Knox) "Shots" blog notes that in addition to family members coping better, the "resuscitation teams say they didn't experience more stress when relatives were present because relatives didn't interfere with the process. And their presence didn't affect things like the duration of CPR or survival rates." According to the blog, "Stephen Borron, a professor of emergency medicine at Texas Tech University and the sole American among the study's authors, thinks it will 'raise the level of the conversation' in the US on allowing family members to witness CPR."
        Also covering the story are Reuters (3/14, Emery), HealthDay (3/14, Salamon), MedPage Today (3/14, Walsh) and Heartwire (3/14, Busko).

Radiation for breast cancer linked to increased risk of heart problems.

Research linking radiation therapy to an increased risk of certain heart problems received a substantial amount of coverage in print and online. Despite the risk, experts said it does not mean that the treatment should not be used in breast cancer patients. Meanwhile, some experts pointed out that radiation treatments now pose less of a danger to the heart than during the time the patients in the study were treated. The Wall Street Journal (3/14, Beck, Subscription Publication, 2.29M) reports that, according toresearch published in the New England Journal of Medicine, women who undergo radiation therapy to treat breast cancer may face a higher risk of certain cardiovascular problems.
        USA Today (3/13, Szabo, 1.71M) reports, "In a study of 2,168 breast cancer patients who had radiation therapy between 1958 and 2001 in Sweden and Denmark, doctors found that any amount of radiation" was linked to a higher risk of "heart attacks, surgeries such as a bypass or angioplasty, or a heart-related death." This research "is the latest to document the serious long-term health problems faced by cancer survivors."
        The New York Times (3/14, Grady, Subscription Publication, 1.68M) reports that the researchers "found that the risk began to increase within a few years after exposure, and that it continued for at least 20 years." The study found that, "the higher the dose, the higher the risk, and there was some increase in risk at even the lowest level of exposure."
        The AP (3/14, Marchione) reports, "Some chemotherapy drugs are known to harm the heart muscle, but the new study shows radiation can hurt arteries, making them prone to harden and clog and cause a heart attack." Patients "who receive both treatments have both types of risk." The AP points out that this research "comes amid greater awareness of overtreatment - that many women are being treated for cancers that would never prove fatal, leading to trouble down the road such as heart disease."
        In Forbes (3/13, 928K), Larry Husten writes, "Findings from the study, according to the authors, 'make it possible to estimate' a patient's risk for heart disease related to radiation."
        The Los Angeles Times (3/13, Brown, 692K) "Booster Shots" blog reports, "Writing in an editorial that accompanied the study, Dr. Javid Moslehi, co-director of the Cardio-Oncology Program at Brigham and Women's Hospital in Boston, argued that the findings should bolster efforts to offer cancer patients specialized cardiac treatment as they battle their disease." Dr. Moslehi "also suggested that the breast cancer-radiotherapy study might represent merely 'the tip of the iceberg' - that exposure to radiation might also increase risks of conditions like pericardial disease and arrhythmias." Additionally, "cancer treatments beyond radiation therapy might also increase heart disease risk, he said."
        The Boston Globe (3/14, Kotz, 250K) "Daily Dose" blog reports, however, that some "oncologists...caution that the study findings may not apply to modern radiation treatments for breast cancer, which deliver lower doses using more targeted methods to minimize exposure to the heart." Meanwhile, study co-author Dr. Candace Correa said, "Breast cancer patients who are candidates for radiation should still receive radiation." Also covering the story are Reuters (3/14, Emery), MedPage Today (3/14), HealthDay (3/14, Doheny), and Medscape (3/14, Lowry).