FDA Strengthens Warning On Labels Of Two Diabetes Medications To Reflect Risk Of Acute Kidney Injuries.

MedPage Today (6/14, Brown) reports that “the FDA is strengthening a warning on the labels of two diabetes drugs to reflect risk of acute kidney injuries.” The “new labels for the two sodium-glucose transport 2 (SGLT-2) drugs – canagliflozin (Invokana) and dapagliflozin (Farxiga) – will have more information about acute kidney injuries and add recommendations about how to minimize risk, said the FDA on its website” yesterday. The FDA “says that the strengthened warning comes after they have received reports of 101 confirmable cases of acute kidney injury from March of 2013 to October of” last year.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm

PPIs May Be Linked To An Increased Risk Of CKD.

ABC World News Tonight (4/14, story 10, 0:25, Muir) reported that a study has linked “proton pump inhibitors including Nexium [esomeprazole magnesium] and Prilosec [omeprazole] to an increased risk of chronic kidney disease [CKD].”

According to CNN (4/14, Christensen), some “173,321 people who used PPIs and 20,270” who “took a PPI alternative known as histamine H2 receptor blockers” were included in the five-year study.

The CBS News (4/14, Welch) website reports that “over five years of follow-up...15 percent of people using PPIs were diagnosed with chronic kidney disease, versus 11 percent of those on H2-blockers,” which “translated to a 28 percent increased risk of developing kidney disease for PPI users.” While just “a few patients in the study – less than 0.2 percent – developed end-stage kidney failure..the risk was 96 percent higher for those on PPIs.” The study was published online in the Journal of the American Society of Nephrology.

Ultra-Processed Foods Now Make Up 58% Of All Calories Americans Consume In A Typical Day, Study Finds.

The Los Angeles Times (3/9, Kaplan) reports in “Science Now” that “ultra-processed foods” now “make up 58% of all calories Americans consume in a typical day,” a studypublished in BMJ Open reveals.

TIME (3/9, Park) reports that the study also found that “this type of processed food as the main source of added sugar in the US diet.” The study defined ultra-processed food “as food that contains ingredients such as flavors, colors, sweeteners and hydrogenated oils, emulsifiers and other additives that you wouldn’t cook with at home.” Also covering the story are Newsweek (3/9, Firger), STAT (3/9, Samuel), MedPage Today (3/9, Brown), and HealthDay (3/9, Reinberg).

BMI mislabels 54 million Americans as 'overweight' or 'obese,' study says

http://www.latimes.com/science/sciencenow/la-sci-sn-bmi-does-not-measure-health-20160204-story.html

A new study out of UCLA finds that people with high BMIs categorizing them as overweight or obese might actually be quite healthy according to more reliable markers of health. 

 (Wang Zhide / Getty Images)

Amina Khan Contact Reporter

Good news for some in the high-BMI crowd: A new study from UCLA finds that some 54 million Americans who are labeled as obese or overweight according to their body mass index are, when you take a closer look, actually healthy.

The findings, published in the International Journal of Obesity, reveal that employers could potentially saddle people with unfairly high health insurance costs based on a deeply flawed measure of actual health.

“This should be a final nail in the coffin for BMI,” said lead author A. Janet Tomiyama, a psychologist at UCLA.

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Body mass index is calculated by dividing a person’s weight in kilograms by the square of the person’s height in meters. According to the Centers for Disease Control and Prevention, a “healthy” BMI is 18.5-24.9, an overweight BMI is 25-29.9 and an obese BMI is 30 or higher. The calculation has been seen as a slightly more nuanced way to measure health than weight alone.

Weight-loss surgery may reduce depression in some patients, study suggests

But over time, researchers have begun to suspect that people with so-called “healthy” BMIs can be very unhealthy, and those with high BMIs can actually be in very good shape.

“The public is used to hearing ‘obesity,’ and they mistakenly see it as a death sentence,” Tomiyama said. “But obesity is just a number based on BMI, and we think BMI is just a really crude and terrible indicator of someone’s health.”

That would be a pretty big deal, especially since the U.S. Equal Employment Opportunity Commission recently proposed rules that would allow employers to penalize employees for up to 30% of their health insurance costs if they don’t meet 24 health criteria — which include meeting a specific BMI. If body mass index doesn’t accurately reflect health, then those with high BMIs potentially could be overcharged for no reason.

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To find out whether BMI correlated with actual markers of health, a team of UCLA researchers analyzed data from 40,420 individuals who participated in the 2005-2012 National Health and Nutrition Examination Survey. They looked at individuals’ blood pressure, triglycerides, cholesterol, glucose, insulin resistance and C-reactive protein data — markers that are linked to heart disease and inflammation, among other issues.

They found that nearly half (47.4%) of overweight people and 29% of obese people were, from a metabolic standpoint, quite healthy. On the flip side, more than 30% of individuals with “normal” weights were metabolically unhealthy.  

Pear-shaped vs. apple trumps body mass index as a measure of risk

“The reason I think people rely on BMI is because it’s easy; if you know someone’s weight and you know someone’s height, then out pops this magical number,” Tomiyama said. “But getting blood pressure is pretty easy too. It takes maybe 20 seconds if you have the machine. And so I really think focusing on better health markers like blood pressure is a better way to go about it — particularly when we’re talking about financial penalties.”

Their results showed that using BMI as the primary indicator of health means that 74.9 million adults in the U.S. are being miscategorized as healthy or unhealthy. (That includes the 34.4 million people who are considered overweight and the 19.8 million people considered obese, according to BMI.)

“Policymakers should consider the unintended consequences of relying solely on BMI,” the authors wrote in the study, “and researchers should seek to improve diagnostic tools related to weight and cardiometabolic health.”

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Proton Pump Inhibitors May Be Linked To Higher Rates Of CKD.

The Washington Post (1/12, Bernstein) “To Your Health” blog reports that research published in JAMA Internal Medicine suggests that proton pump inhibitors may be linked to “higher rates of chronic kidney disease [CKD].” Researchers “studied the records of more than 10,000 people treated in community-based settings.” The investigators “found a 20 percent to 50 percent greater risk of the onset of” CKD “among users of the drugs than those who did not take them.”

The NPR (1/12, Stein) “Shots” blog reports that the investigators also studied “248,751 patients in the Geisinger Health System in Pennsylvania.” The data indicated that “the 10-year absolute risk” for CKD “among the 16,900 patients using PPIs in the” health system “was 15.6 percent, whereas 13.9 percent would have been expected to develop” CKD. Also covering the story are Reuters (1/12, Rapaport), HealthDay (1/12, Thompson), MedPage Today (1/12, Boyles), and Medscape (1/12, Kelly).

HHS, USDA Release Updated Dietary Guidelines.

The CBS Evening News (1/7, story 9, 2:10, Pelley) reported, “Today the government revised its advice for a healthy diet. The headlines: Lean meat and eggs may now be okay, but sugar and salt still bad.”

USA Today (1/8, Szabo) reports that the new guidelines, from the US Department of Agriculture and the US Department of Health and Human Services, recommend “limiting the amount of added sugars in our diet to no more than 10% of daily calories,” which is approximately “12 teaspoons of sugar a day.”

The Los Angeles Times (1/8, Healy) reports, “Essentially, the latest edition of the Dietary Guidelines for Americans nudges the country’s nutritional policy toward a traditional Mediterranean diet.”

The AP (1/8, Jalonick) reports that reducing “sodium intake was the major push of the 2010 guidelines, and that document recommended that those most at risk of heart disease, or about half the population, lower their intake to 1,500 mg.” However, “the new guidelines delete that lower amount as part of the top recommendations.” But, “the report says those with high blood pressure and prehypertension could benefit from a steeper reduction.”

However, according to the New York Times (1/8, A3, O'Connor), “the guidelines were also notable for what they did not say.” Although “draft recommendations had suggested all Americans adopt more environmentally-sustainable eating habits by cutting back on meat, that advice was dropped from the final guidelines.” Meanwhile, “longstanding limits on dietary cholesterol were also removed.”

Dallas-Based Dietary Supplement Maker Indicted For Fraud As Part Of “Widespread Crackdown.”

The Wall Street Journal (11/18, Burton, Subscription Publication) reports that dietary supplement maker USPlabs LLC and its executives were charged with fraud by a Federal grand jury in Texas on Tuesday. Officials from the Justice Department, the Food and Drug Administration, the Federal Trade Commission, the US Postal Inspection Service, and other agencies say the indictment was part of a nationwide effort targeting illegal marketing of dietary supplements.

The New York Times (11/17, B2, O'Connor) reports in its “Well” blog that the USPlabs indictment is “at the center” of a “yearlong federal investigation into the dietary supplement industry,” resulting in a “widespread crackdown on more than 100 companies accused of selling tainted or misleading products.” USPlabs sold a supplement, OxyElite Pro, linked to a 2013 outbreak of liver disease that killed one person and sickened 97 people.

Bloomberg News (11/17, Mittelman, Townsend) reports that SK Laboratories Inc., “which makes supplements for USPlabs, was also charged in the case.”

The AP (11/18, Tucker) reports that USPlabs was directed by the FDA to recall its OxyElite Pro product in 2013, and while it told the agency it would stop distributing it, it instead began a “surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible,” according to the criminal complaint.

The Washington Post (11/17, Merle, Dennis) reports that USPlabs allegedly told retailers that some of its products had natural plant extracts that were actually a synthetic stimulant made in a chemical factory in China, the DOJ complaint alleges.

The Hill (11/18, Wheeler) reports that the DOJ also filed civil cases against Vibrant Life, Viruxo, Optimum Health, Bethel Nutritional Consulting and Regeneca Worldwide. The Federal Trade Commission “has also taken civil actions against Sunrise Nutraceuticals LLC, Health Nutrition Products and NPB Advertising Inc.” for allegedly “making false, misleading or unsubstantiated health and [effectiveness] claims.”

Also covering the story are Reuters (11/18, Bartz), a separate Bloomberg News (11/18, McLaughlin) article, the CBS News (11/18, Gibson) website, the NBC News (11/18, Fox) website, the NPR (11/17, Wagner) “The Two-Way,” the Dallas Morning News (11/18, Lindenberger), Stat (11/17, Swetlitz), Vox (11/17, Belluz), and the Food Safety News(11/18, Flynn).

FDA Approves Drug To Treat Multiple Myeloma.

Source: http://www.cancer.gov/images/cdr/live/CDR763079-750.jpg

The AP (11/17, Johnson) reports that the Food and Drug Administration approved Johnson & Johnson’s Darzalex (daratumumab), a drug “for treating the incurable blood cancer multiple myeloma in patients who’ve failed prior therapies and have few options left.” The drug is not only the first biologic, but also the first monoclonal antibody approved to treat multiple myeloma.

Also covering the story are Reuters (11/17, Pierson), HealthDay (11/17, Roberts), MedPage Today (11/17, Bankhead), and Medscape (11/17, Chustecka).

WHO Survey Indicates People Lack Understanding Of Antibiotics.

Image Source: http://ibraheem-altowaiher.deviantart.com/art/Antibiotics-MD-198124195

Reuters (11/17, Kelland) reports that according to the World Health Organization, peoples’ misunderstanding and ignorance of antibiotics is contributing to the increase in drug-resistant pathogens. A survey released by the WHO revealed that 64 percent of participants incorrectly believed that antibiotics could be used to treat colds and the flu. Additionally, a third of people surveyed believed that they should stop taking antibiotics when they feel better instead of completing the entire treatment course as prescribed.

CBS News (11/17) reports on its website that the WHO “surveyed nearly 10,000 people across 12 countries as part of the CDC’s ‘Get Smart About Antibiotics Week,’-- an effort to stop the threat posed by resistance to antibiotics.” Meanwhile, another “76 percent of respondents believed antibiotic resistance meant the body was becoming resistant, but it is actually the bacteria that is becoming resistant.” Medscape (11/17, Brooks) also reports on the story.

ESRD Risk Tool for Kidney Donor Candidates

Based on the latest NEJM 2015 article 

http://www.transplantmodels.com/esrdrisk/

Is 120 mm Hg the new BP target? What headlines aren’t telling you

The results of the SPRINT trial are in, and you’ve probably heard that making 120 mm Hg the new blood pressure target helped lower mortality rates. Yet the study outcomes apply only to a specific subset of patients with hypertension. See whether or not your patients may fit into this category. Read more at AMA Wire®.

Lowering Blood Pressure Target May Lead To Lower Rates Of CV Events.

The CBS Evening News (11/9, story 9, 1:25, Pelley) reported that “a new study that says sharply lower blood pressure leads to significantly longer lives.” On ABC World News(11/9, story 8, 1:00, Muir), ABC’s Dr. Richard Besser reported, “The results were so startling, they stopped the study...early.”

In a 1,300-word article, the New York Times (11/10, Kolata, Subscription Publication) reports that investigators found that “among the 9,361 hypertension patients followed for an average of 3.2 years, there were 27 percent fewer deaths (155 compared with 210) and 38 percent fewer cases of heart failure (62 compared with 100) among patients who achieved the systolic pressure target of 120 than among those who achieved the current 140 target.” Altogether, “there was a 25 percent reduction — 243 compared with 319 — in people who had a heart attack, heart failure or stroke or died from heart disease, Dr. Paul K. Whelton, a principal investigator for the study, said.” The findings were presented at the American Heart Association meeting and published in the New England Journal of Medicine.

The AP (11/10, Marchione) reports that “too-low blood pressure, fainting episodes and more worrisome, kidney problems were 1 percent to 2 percent higher in the lower pressure group.” However, “falls that cause injury due to lightheadedness were not more common, as had been feared especially for older people.”

The Seattle Times (11/10, Aleccia) reports that “the study, dubbed the Systolic Blood Pressure Intervention Trial — or SPRINT — was stopped in September, nearly two years early, when it became clear that radically lowering blood pressure for many people older than 50 helped prevent heart attacks and other heart problems and deaths.”

Reduced-Fat Diets No More Effective Than Other Weight-Loss Diets, Meta-Analysis Suggests.

Bloomberg News (10/29, Tozzi) reports that a meta-analysis published Oct. 29 in The Lancet Diabetes & Endocrinology “finds reducing fat isn’t any more effective for losing weight than other diets.”

The CBS News (10/29, Marcus) website reports that after analyzing data from “53 studies” including “more than 68,000 adults,” researchers found that “reduced-fat diets only led to more weight loss when compared with no diet at all.” Individuals “on low-carbohydrate diets lost substantially more weight than those who went the low-fat route.”

TIME (10/29, Sifferlin) reports that the study authors concluded that “public health guidelines should stop recommending low-fat diets for weight loss, stressing that more research is needed to find what strategy is most effective and able to be maintained.”

Also covering the story are CNBC (10/29, Ferris), Vox, HealthDay (10/29, Doheny), AFP (10/29), the Telegraph (UK) (10/29, Donnelly), and The Guardian (UK) (10/29, Boseley).

FDA Warns Hepatitis C Drugs Could Cause Severe Liver Damage To Patients With Underlying Liver Disease.

The Wall Street Journal (10/23, Loftus, Subscription Publication) reports that the Food and Drug Administration issued a warning on Thursday that AbbVie Inc.’s Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) and Technivie (ombitasvir/paritaprevir/ritonavir) may cause severe liver damage to patients who have an underlying liver disease.

The Washington Post (10/23, Dennis) reports that the FDA said it had received reports of at least 26 cases since late 2014 of patients “who either died or had to undergo liver transplantation” after taking the hepatitis C drugs, with the liver damage occurring in the first month of treatment. According to the Post, the agency “will require AbbVie to add new warnings to the safety labels of the drugs for patients who already have advanced liver disease linked to hepatitis C” and “urged doctors to closely monitor patients taking the drugs for symptoms of worsening liver disease.” Bloomberg News (10/23, Bloomfield) and the AP (10/23, Perrone) also cover the story.

Late Bedtimes May Be Linked To Weight Gain Over Time.

On its website, CBS News (10/3, Welch) reported that research published in Sleep suggests that “going to bed later during the workweek is associated with weight gain over time.” Investigators looked at “data on more than 3,300 teens and young adults recorded at different intervals over the course of about 15 years.”

HealthDay (10/3, Preidt) reported that the investigators “found that each extra hour of late bedtime was associated with a more than two-point increase in body mass index (BMI).” The data indicated that the association “between late bedtimes and BMI increase was not significantly affected by total sleep time, amount of exercise, or time spent in front of computers or televisions.”

Calcium Supplements May Not Strengthen Bones In Women Under 80, Study Finds.

FOX

David Muir reported on ABC World News (9/29, story 10, 0:30, Muir) that new research finds “taking daily calcium supplements does little to strengthen bones in women under 80.” Muir reported, “Only women over 80 and in nursing homes saw hip fractures decrease by 23 percent.”

Correspondent Rehema Ellis reported on NBC Nightly News (9/29, story 7, 2:15, Holt) that investigators “concluded that most people over 50 won’t get stronger bones if they increase their calcium intake.” The findings were published in the British Medical Journal.

Meanwhile, NBC News (9/30) reports on its website that the “extra calcium doesn’t go to strengthen bones but instead can build up in the arteries, causing heart disease, or in the kidneys, causing kidney stones.”

TIME (9/30, Sifferlin) reports the results from the meta-analysis “suggest that clinicians, advocacy organizations and health policymakers should not recommend increasing calcium intake for fracture prevention either with calcium supplements or through dietary sources,” the New Zealand researchers wrote. TIME adds that the “new results also fall in line with the guidance provided by the United States Preventative Services Task Force in 2013,” which, based on the evidence available, ultimately concluded that “post-menopausal women should not take daily supplements.”

Also covering the story are HealthDay (9/30), LiveScience(9/30), and the Telegraph (UK) (9/30).

Diabetes Medication May Reduce Deaths From Cardiovascular Disease, Study Suggests.

The New York Times (9/18, B2, Pollack, Subscription Publication) reports that “for the first time, a widely used modern diabetes” medication “has been shown to reduce deaths from cardiovascular disease, a long-sought goal of treatment, researchers announced” yesterday. The research(9/18) was presented at the annual meeting of the European Association for the Study of Diabetes and published in The New England Journal of Medicine.

On its website, NBC News (9/17) reports that the medication, “called Jardiance [empagliflozin], lowered heart disease deaths by 38 percent and deaths from any cause by 32 percent over three years.”

The AP (9/18, Johnson) reports that the findings “were particularly striking because nearly four-fifths of the participants were already taking standard medicines to control blood sugar, blood pressure and cholesterol, plus taking either Jardiance or a” placebo.

CDC Says Flu Vaccine May Be More Effective This Year.

The CBS Evening News (9/17, story 12, 1:45, Pelley) reported that this year’s influenza vaccine may be more effective than last year’s. According to Dr. Jon Lapook, “Last year, the vaccine was only 23 percent effective because the predominant strain mutated after the vaccine had already been manufactured.” CDC “officials say this year’s flu vaccine is well-matched right now to circulating viruses.”

The Los Angeles Times (9/18, Kaplan) reports that this year, “flu watchdogs at the CDC have scrutinized 199 flu specimens collected in the United States and elsewhere between May 24 and Sept. 5.” They found that “the majority of those specimens – 118 of them – were H3N2 viruses, and all of them were built in a way that should make them vulnerable to this year’s vaccines.”

McClatchy (9/18, Mueller) reports that “by including components of H3N2 in this season’s flu vaccine, health care professionals hope to raise vaccine effectiveness against predominant strains back up to the 50 to 60 percent range.”

The AP (9/18, Neergaard) reports that, “all told, at least 171 million doses of flu vaccine are expected this year.” Meanwhile, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, said “it doesn’t matter which flu vaccine you get, just get one.”

Guidelines For Chronic Kidney Disease Diagnosis Cause Debate Among Physicians.

The New York Times (9/15, Span, Subscription Publication) reports that the guidelines for the diagnosis of chronic kidney disease are causing debate among physicians, with some arguing “that the guidelines should be recalibrated by age.” Authors of a recent viewpoint article in JAMA “propose that in people older than 65, the diagnosis should require a G.F.R. [glomerular filtration rate] reading less than 45,” as opposed to the current reading of 60, which they estimate will reduce “a third to half of the chronic kidney disease diagnosed.” Authors of an opposing viewpoint article, however, “warned against changing the guidelines,” saying that people need to know that they have low GFR levels in order to “take some steps to reduce the risk of eventual kidney failure, even if that’s already extremely low.”

Aggressive Blood-Pressure Reduction May Reduce Cardiovascular Problems, Deaths.

During its Friday broadcast, NBC Nightly News (9/11, story 7, 2:05, Snow) reported, “The National Institutes of Health said today that more aggressively lowering target blood pressure would cut the death rate by a staggering 25 percent.”

In a 1,200-word story on its front page, the New York Times(9/12, A1, Kolata, Subscription Publication) reported that in the study, researchers “randomly assigned more than 9,300 men and women ages 50 and over who were at high risk of heart disease or had kidney disease to one of two systolic blood pressure targets: less than 120 millimeters of mercury, which is lower than any guideline ever suggested, or less than 140.” The researchers “found that patients who were assigned to reach a systolic blood pressure goal below 120 — far lower than current guidelines of 140, and 150 for people over 60 — had their risk of heart attacks, heart failure and strokes reduced by a third and their risk of death reduced by nearly a quarter.”

The AP (9/12, Neergaard) reported that “the benefit was strong enough that NIH stopped the study about a year early.”

The Wall Street Journal (9/12, A1, Armao, Whalen, Subscription Publication) reported on its front page that during a conference call during which the findings were announced, Dr. Gary H. Gibbons, director of the National Heart, Lung and Blood Institute, said, “More intensive management of high blood pressure in people 50 years and older can save lives and reduce cardiovascular complications, such as heart attacks.” Gibbons added, “This new important information has the potential to benefit a portion of the estimated one in three adults in the United States who suffer from high blood pressure, as well as millions of others worldwide.”

On its front page, the Washington Post (9/12, A1, Bernstein) points out that “the NHBLI was the primary sponsor of the” research. In a statement, Dr. Gibbons said, “This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50.”

USA Today (9/12, Szabo) reported, however, that “NIH researchers did not provide any details about how many lives were saved or the side effects of lowering blood pressure so dramatically.”

Also covering the story were Reuters (9/12, Berkrot), Forbes (9/12, Hedgecock), the NPR (9/12, Stein) “Shots” blog, Newsweek (9/12, Firger), CNN (9/12, Capelouto, Goldschmidt), the Huffington Post (9/12), TIME (9/12, Luckerson), Medscape (9/12, O'Riordan), and HealthDay(9/12, Thompson, Reinberg).