Study: Smoking Can Take At Least Ten Years Off Life Expectancy.

Two studies on smoking and mortality published this week in the New England Journal of Medicine received significant coverage from print and online news sources, and from two national news broadcasts. One study was led by Dr. Prabhat Jha of the Center for Global Health Research in Toronto, while the other study was led by Michael J. Thun of the American Cancer Society. Both studies found that quitting smoking helped to reduce the risk of death associated with smoking - a point that most reports focused on. Additionally, much of the coverage discussed the finding that women are now as likely to die from smoking-related illnesses as men.

        NBC Nightly News (1/23, story 10, 0:25, Williams) reported, "good news and bad news on the smoking front. From the New England Journal of Medicine, they state flat out, smokers lose at least one decade of life expectancy over nonsmokers on average."

        CBS Evening News (1/23, story 9, 0:25, Pelley) reported, "A new study is finding that smoking is taking a much greater toll on women than it used to."

        USA Today  (1/23, Payne) reports that one of the studies found that "people who smoke take at least 10 years off their life expectancy." The article adds, "on the other hand, those who kick the habit before age 40 reduce the excess risk of death associated with continued smoking by about 90%, according to the study in Thursday's New England Journal of Medicine." According to USA Today, "the study examined data from the U.S. National Health Interview Survey between 1997 and 2004."

        In its "Well" blog, the New York Times  (1/23, O'Connor) quotes Dr. Tim McAfee, an author of the study and the director of the CDC's Office on Smoking and Public Health, as saying that the findings "paint a much more dramatic picture of the horror of smoking. These are real people that are getting 10 years of life expectancy hacked off - and that's just on average."

        The Washington Post  (1/24, Vastag) reports that the other study found that "smoking-related deaths among women have soared in recent decades. For the first time since research on smoking and health began in the 1950s, the rate of smoking-related deaths is now nearly equal between male and female smokers."

        The Los Angeles Times  (1/24, Khan) reports that "in the early 1960s, women smokers were 2.73 times more likely to die from lung cancer than their nonsmoking counterparts; by 2010, they were 25.66 times more likely to die of the disease, Thun found."

Diuretic Protocol May Benefit Patients With Acute Heart Failure.

MedPage Today  (1/24, Kaiser) reports, "A diuretic protocol designed to allow rapid real-time assessment and adjustment of treatment for acute heart failure patients showed gains, but also potential losses, according to an observational study  " published online in Congestive Heart Failure. Investigators found that "patients with acute decompensated heart failure on the diuretic protocol were 54% less likely to be readmitted to the hospital compared with the usual care group (OR 0.46, 95% CI 0.22 to 0.95, P=0.037)." Patients "in the protocol group also lost a mean 17 lbs. per patient per hospital stay compared with 6 lbs. for the usual care group (P<0.001)."

Peginesatide May Increase Risk Of CV Events In CKD Patients Not Undergoing Hemodialysis.

MedPage Today  (1/24, Gever) reports, "The anemia drug peginesatide (Omontys) in chronic kidney disease patients not undergoing hemodialysis may carry an increased risk of cardiovascular events, results of two paired trials suggested." Investigators reported that "pooled data from two studies enrolling such patients - dubbed PEARL-1 and PEARL-2 - yielded a hazard ratio of 1.32 for a composite safety endpoint that included all-cause mortality, stroke, myocardial infarction, congestive heart failure, unstable angina, and cardiac arrhythmia (95% CI 0.97 to 1.81) with peginesatide relative to darbepoetin alfa (Aranesp)." Meanwhile, "no such increase in cardiovascular risk was seen in two other trials labeled EMERALD 1 and 2 that used the identical composite safety endpoint but enrolled patients who were on dialysis." The findings were published in the New England Journal of Medicine.

Researchers Identify Risk Factors For AKI In ICU Patients.

Renal and Urology News  (1/24, Charnow) reports, "Risk factors for acute kidney injury (AKI) among patients in the intensive care unit (ICU) include hypovolemia, use of diuretics, and the presence of chronic kidney disease (CKD) prior to ICU admission, according to a prospective, population-based Finnish study" published online in Intensive Care Medicine. Investigators looked at data on about 2,900 ICU patients. The researchers found, "after adjusting for multiple variables," that "pre-ICU hypovolemia and CKD were independently associated with a 2.2 times and 2.6 times increased risk for AKI." Meanwhile, "pre-ICU use of diuretics and colloids were independently associated with a 68% and 35% increased risk."

NYTimes Laments Amgen's "Disheartening" Congressional Win.

In continuing coverage, the New York Times  (1/23, A20, Subscription Publication) editorializes that the provision in the fiscal bill, extending by two more years the exclusion of "certain oral drugs," including Amgen's Sensipar (cinacalcel), which was set "to expire in 2014," from Medicare's "more cost-effective bundled system," is a "disheartening example of how intense lobbying and financial contributions can distort the legislative process in Washington." The Times contends that although other pharmaceutical companies will "benefit financially from that delay, Amgen, which has 74 lobbyists in Washington, was the only company to lobby aggressively" for the postponement, which will "cost the Medicare program up to $500 million over a two-year period."

Congressmen Seek To Close Amgen Loophole In Fiscal Cliff Bill.

The Los Angeles Times  (1/25, Terhune) reports, "A bipartisan group of U.S. lawmakers is seeking to repeal a Medicare-pricing provision in the recent 'fiscal cliff' deal that benefits biotech giant Amgen Inc." Rep. Peter Welch (D-VT), "filed legislation this week to eliminate the exemption for a class of drugs, including Amgen's Sensipar, that are used by kidney dialysis patients." The fiscal cliff deal had "excluded these oral medications from Medicare price controls for an additional two years." Welch was joined by co-sponsors including Rep. Richard Hanna (R-NY), Jim Cooper (D-TN), and Bruce Braley (D-IA).

        Amgen Responds To Legislation. The Hill  (1/25, Baker) "Healthwatch" blog reports that Amgen "is defending a change in Medicare payments included in the recent fiscal-cliff deal and pushing back against a new bill to repeal that change." In a statement responding to Welch's legislation, the company said, "Amgen supports the current provision to delay including oral-only medications in the Medicare dialysis prospective payment system. Including oral-only medications in the payment system at the same time that the bundle is being rebased would have been disruptive to quality patient care." The statement continued, "A two-year delay provides [Medicare] with the time needed to develop quality metrics and further develop their data systems - both things pivotal to providing quality patient care."

Prednisolone/Chlorambucil Combo May Benefit Patients With Idiopathic Membranous Nephropathy.

Medwire  (1/19, Robertson) reports, "A combination of prednisolone and chlorambucil is the most effective treatment approach for patients with idiopathic membranous nephropathy and declining renal function, according to findings from a recent trial  " published online in The Lancet. Investigators found, "in this randomized controlled trial, patients who had a 20% or greater decline in excretory renal function prior to study entry benefited from prednisolone plus chlorambucil therapy for at least 3 years of follow-up." Meanwhile, "the nephrotoxicity seen with ciclosporin monotherapy make it a poor choice for this patient subset," the researchers found.

FDA Approves Next-Generation Flu Vaccine.

Coverage of the Food and Drug Administration's approval of Protein Sciences Corporation's next-generation influenza vaccine was light. But the news outlets that did cover it, were highly positive, lauding the Flublok vaccine as a scientific breakthrough and noting the impact it could have on tempering the nation's seasonal flu rates.

        The CBS Evening News (1/16, story 8, 0:20, Pelley) reported, "The FDA approved a new flu vaccine today. It's called Flublok, and unlike other flu vaccines, it is not made with the influenza virus or with eggs. The flu virus is widespread now in 47 states. It has taken the lives of 20 children."

        The New York Times  (1/17, B6, Pollack, Subscription Publication) reports that the FDA announced  it has approved a "new type of flu vaccine" on Wednesday. Protein Sciences Corp., which developed the Flublok vaccine, explained that it is "made with a process that does not require the virus to be grown in chicken eggs, as is now generally done." Flublok needs neither the eggs nor the live influenza virus because it is "made by putting the gene" for flu virus' hemagglutinin (HA) protein, into a virus that infects the cells of an insect, "the fall armyworm." The FDA's Center for Biologics Evaluation and Research Director, Dr. Karen Midthun, said the approval of Flublok "represents a technological advance in the manufacturing of an influenza vaccine."

        NBC News  (1/17, Aleccia) on its website says that according to the FDA, the vaccine "contains three full-length recombinant HA proteins to help protect against three strains of the flu including two influenza A viruses, H1N1 and H3N2, and one strain of influenza B." Protein Sciences CEO Manon Cox noted that with the Flublok's "novel manufacturing technology," large quantities of the vaccine can be produced quickly. The Meriden, Connecticut-based biopharmaceutical firm has already produced "about 150,000 doses" of Flublok; and Cox said the company expects to begin distributing the vaccine "by mid-February to people with egg allergies and others who are unable to receive current flu vaccines."