Wednesday, November 18, 2015

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).

Tuesday, November 17, 2015

FDA Approves Drug To Treat Multiple Myeloma.


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.

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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.

Sunday, November 15, 2015

Saturday, November 14, 2015

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®.

Tuesday, November 10, 2015

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.”