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.

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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).