Baxter To Buy Renal Products Firm For $4B.

The Wall Street Journal  (12/5, B4, Cimilluca, Subscription Publication) reports that as part of its effort to expand its presence in the growing renal therapy market, Deerfield, Illinois-based Baxter International Inc. announced  it has entered an agreement to acquire Lund, Sweden-based Gambro for 26.5 billion Swedish kronor ($4 billion). The Journal says Baxter is the world's second, and Gambro is world's third, biggest producer of kidney dialysis products and acute or chronic kidney disease therapies.

        The Chicago Tribune  (12/4, Frost) reports that Baxter CEO Robert Parkinson "told analysts in a conference call that the acquisition would allow it to grow Gambro's business in emerging and high-growth markets in countries like Brazil and China, where many patients with kidney failure go untreated."

        The pending acquisition is also covered by the New York Times  (12/5, Scott, Subscription Publication) "Dealbook" blog, theAP  (12/5), Bloomberg News  (12/5, Tirrell), Reuters  (12/5, Sherman, Humer), Forbes  (12/5, Japsen), theChicago Sun-Times  (12/5, Knowles), and the Chicago Business Journal  (12/4).

Study Shows Aspirin's Protective Coating May Interfere With Benefits.

On the front page of its "Business" section, the New York Times  (12/5, B1, Thomas, Subscription Publication) reports on a study published in the journal Circulation, which found that "while aspirin may prevent heart attacks and strokes, a commonly used coating to protect the stomach may obscure the benefits, leading doctors to prescribe more expensive prescription drugs. The conclusion about coated aspirin was only one finding in the study, whose main goal was to test the hotly disputed idea that aspirin does not help prevent heart attacks or stroke in some people." Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania and one of the study's authors, said in a statement, "These studies question the value of coated, low-dose aspirin. This product adds cost to treatment, without any clear benefit. Indeed, it may lead to the false diagnosis of aspirin resistance and the failure to provide patients with an effective therapy."

        The Wall Street Journal  (12/5, Winslow, Subscription Publication) reports that the study was funded by the National Heart, Lung and Blood Institute, the American Heart Association and Bayer. Bayer's HealthCare unit noted that the findings should not discourage use of coated aspirin because studies have shown that it cuts heart risk with a low incidence of gastrointestinal bleeding.

Digoxin associated with higher mortality in afib patients

Digoxin was associated with a significant increase in all-cause mortality in patients with atrial fibrillation, regardless of gender and whether they had had heart failure, a study found.

To determine the relationship between digoxin and mortality in patients with atrial fibrillation, researchers assessed patients enrolled in the AF Follow-Up Investigation of Rhythm Management (AFFIRM) trial. Analyses were conducted in all patients and in subsets according to the presence or absence of heart failure, as defined by a history of heart failure and/or an ejection fraction less than 40%. Results appeared online Nov. 27 in the European Heart Journal.

Digoxin was associated with an increase in all-cause mortality (estimated hazard ratio [EHR], 1.41; P<0.001), cardiovascular mortality (EHR, 1.35; P=0.016), and arrhythmic mortality (EHR, 1.61; P=0.009). The all-cause mortality was increased with digoxin in patients without or with heart failure (EHR, 1.37; P=0.019 and EHR, 1.41; P=0.010, respectively). There was no significant interaction between digoxin and gender for all-cause (P=0.70) or cardiovascular (P=0.95) mortality.

All-cause mortality was 41% higher in patients with heart failure and 37% higher in patients without heart failure. These findings call into question the widespread use of digoxin in patients with atrial fibrillation, researchers wrote. Recent studies put its use at between 35% and 70% of these patients, despite limited safety data and controversy over its use. The authors noted several limitations to the study, including lack of data on serum digoxin level and kidney function.

Appeals Court Overturns Off-Label Marketing Conviction.

On the front page of its Business Day section, the New York Times  (12/4, B1, Thomas, Subscription Publication) reports, "In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration." In its decision, the "three-judge panel of the Court of Appeals for the Second Circuit in Manhattan" wrote that the ban on "off-label marketing" violated the First Amendment and "cited as precedent a 2011 Supreme Court decision, Sorrell vs. IMS Health," in which the "high court, citing freedom of speech, overturned a Vermont law restricting pharmaceutical companies from using prescription data for marketing purposes."

        Reuters  (12/4, Stempel, Ingram) explains that in 2005, Federal prosecutors accused Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical, of promoting the company's narcolepsy treatment, Xyrem (sodium oxybate), for off-label uses ranging from chronic fatigue and excessive daytime sleepiness to muscle disorders and persistent pain. Caronia was convicted in 2008 of violating the Federal Food, Drug & Cosmetic Act (FDCA). Monday's ruling by 2nd US Circuit Court of Appeals in New York overturned that conviction.

        The Wall Street Journal  (12/4, Burton, Subscription Publication) reports that the three-judge panel voted 2-1 to overturn the conviction. The Journal quotes the dissenting Judge Debra Ann Livingston as saying she supported the 2008 conviction "because the First Amendment has never prohibited the government from using speech as evidence of motive or intent" and that Monday's ruling "calls into question the very foundations of our century-old system of drug regulation." The Journal says the Federal government could appeal to the Supreme Court, but by doing so, the FDA would risk having its off-label marketing rules struck down en masse. The Journal adds that an FDA spokesperson declined to comment, noting that the litigation is ongoing.

        The Wall Street Journal  (12/4, Jones) "Law Blog" notes that Caronia was convicted in 2008 for violating the FDCA by conspiring to introduce a misbranded drug into interstate commerce. In the majority opinion on Monday, the Appeals Court judges stressed that although the FDCA does prohibit off-label drug promotion, the Act does not penalize physicians who prescribe drugs for off-label uses.

        According to Bloomberg News  (12/3, Fisk), Judge Denny Chin wrote in the majority opinion that the Federal "government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug." Chin opined that the "proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing." Bloomberg adds that Justice Department spokesperson Dean Boyd declined provide comment at this time.

Diet May Reduce Risk Of Recurrent Heart Attacks.

USA Today  (12/2, Szabo) reports on a study  published in the journal Circulation, finding that "people with heart disease who adopt a healthy diet -- in addition to taking their medications -- cut their risk of dying from heart disease by an additional 35%. ... The healthy eaters in the nearly 4½-year study also cut their risk of another heart attack by 14%; a stroke by 19%; and congestive heart failure by 28%." Study author Mahshid Dehghan, McMaster University in Ontario, Canada, said, "Even a slight change in diet has a good effect." The study covered 32,000 patients who "were taking medications such as aspirin...statins; and blood pressure medications." The researchers said that "they observed what people were eating, and adjusted their findings for factors such as weight, smoking and exercise," but "they acknowledge that something other than diet could have lowered patient's heart disease risks."

        On the front of its Personal Journal section, the Wall Street Journal  (12/4, D1, Dooren, Subscription Publication) reports that the participants in the study all had a history of heart disease, stroke or Type 2 diabetes and were 55 or older. Participants were categorized into five levels of heart-healthy diet based on how often they reported eating dairy, meat, fish, fruits, and vegetables, as well as fried foods and whole grains.

        The Huffington Post  (12/3) remarks, "The positive effects of a fruit-and-veggie-heavy diet on the heart are hardly surprising."

        HealthDay  (12/4, Reinberg) reports, "The study included countries in North America, South America, Europe, Australia, Asia and the Middle East." Among the participants, "over five years of follow-up, more than 5,000 had a heart attack or stroke."

        Heartwire  (12/4, Nainggolan) quotes Dehghan, who said, "Our main finding was that a heart-healthy diet-rich in fruits, vegetables, nuts, whole grains, and fish-significantly reduced the chance of a second heart attack or stroke or death." Indeed, "consumption of such a diet reduced the relative risk of cardiovascular death by 35%, MI by 14%, stroke by 19%, and congestive heart failure (CHF) by 28%, compared with those eating the poorest diet."

Overweight, Obesity In Adolescence May Increase ESRD Risk Later.

Medwire  (12/3, Robertson) reports, "Being overweight or obese in adolescence increases a person's risk for end-stage renal disease (ESRD) in later life," according to a study  published Nov. 26 in the Archives of Internal Medicine. "In a retrospective analysis of 1,194,704 Israeli adolescents, aged a mean of 17.4 years, who underwent health examinations for military service between 1967 and 1997, the team linked health data to the Israeli ESRD registry, which holds information on any patients receiving treatment for ESRD between 1980 and 2010." Notably, "the incidence of treated ESRD was significantly increased among individuals who were overweight (BMI 24.90-28.19 kg/m2 for boys and 25.20-29.59 kg/m2 for girls) or obese (BMI 28.20-40.00 kg/m2 for boys and 29.60-40.00 kg/m2 for girls) during adolescence, compared with those of normal weight (BMI 17.71-24.89 kg/m2 for boys and 17.21-25.19 kg/m2 for girls)."