Policy, Ethics, Education Archives - Page 7 of 10 - PulmCCM

Policy, Ethics, Education Articles

Jan 062012
Big bucks riding on FDA's little dosing decision for indacaterol (NEJM)

In July 2011, FDA approved indacaterol, Novartis’s new once-daily long-acting beta agonist, for the treatment of chronic obstructive pulmonary disease. In contrast to its European counterpart (EMA), which approved indacaterol there at doses up to 300 mcg, FDA only approved indacaterol in the 75 mcg daily dose. The FDA’s Badrul Chowdhury explains why in the [… read more]

Jan 012012
ACP advises against universal DVT/PE prophylaxis! "Quality" quagmire thickens (Guideline/Review, Ann Intern Med)

Daunted by the seeming impossibility of measuring and comparing hospitals on real outcomes (given our primitive state of data collection and heterogeneity in patient populations, among many other challenges), well-meaning bureaucrats and non-profiteering safety advocates like the Institute for Healthcare Improvement have created directives based on surrogate measures in an attempt to standardize and improve [… read more]

Jan 012012
Xigris X'd! PROWESS-SHOCK negative; activated protein C yanked from global market

A newer post is available reviewing the final published findings for PROWESS-SHOCK in NEJM. PROWESS-SHOCK results are in, and they sounded the death knell for drotecogin alfa (activated protein C / Xigris), Eli Lilly’s often-challenged blockbuster drug for septic shock. Investigators reported a 28-day all-cause mortality rate of 26.4% in patients treated with activated drotrecogin [… read more]

Jan 012012

Every July, 100,000 house staff change jobs, with the sudden arrival of huge cohorts of promising talented young interns who also happen to be (by definition, and speaking from personal experience) disoriented and incompetent. Does changeover result in excess mortality — the so-called “July effect” in the U.S. (in the U.K., they go right ahead and [… read more]

Jan 012012

The smoking cessation drug varenicline (Chantix) got a black-box warning in 2009 after the FDA received >500 reports of suicidal thoughts and behaviors, and 32 completed suicides in the U.S. (This was out of several million prescriptions filled, though.) After that postmarketing surprise, the FDA sponsored 2 observational studies in Chantix users: one at the [… read more]

Jan 012012

The National Lung Screening Trial demonstrated annual screening with chest CT saves one life per 320 screened compared to yearly screening with chest radiography. However, there was no “usual care” group (no screening at all) to compare against. Oken et al report additional results from the PLCO Trial (Prostate, Lung, Colorectal, and Ovarian Cancer Screening [… read more]

Jan 012012

After receiving hundreds of postmarketing adverse event reports of suicidal thoughts or behaviors (and 32 completed suicides) associated with smoking cessation drug varenicline (Chantix), the FDA slapped a black box warning on the med in 2009 and commissioned two large retrospective observational studies totaling more than 40,000 patients starting either varenicline (Chantix) or nicotine replacement. [… read more]

Jan 012012

This 2012 post will not be updated or reviewed to incorporate new research findings, and may be outdated. Talk to your doctor before using e-cigarettes. By reading you accept the terms of use. Quitting smoking is astoundingly difficult: only about 3% stay quit at 6 months without help. Using nicotine replacement therapy increases that to 9%. The more [… read more]

Jan 012012

Each individual episode of critical illness produces a mushroom cloud of data, most of which dissipates without being recorded at all (think realtime infusion rates of vasopressors and continuous ECG monitoring). A few large databases capture outcomes data from multiple participating hospitals (like the National Inpatient Sample), and the new MIMIC-II integrated data system can [… read more]

Dec 262011

Results of the National Lung Screening Trial (NLST) are in! Enrollment was 8/2002 to 4/2004. Follow-up was through end of 2009. Patients were age 55-74, with >30 pack-year smoking history, still smoking or quit <15 years. Intervention / Control: Low-dose chest CT vs. chest plain films thrice-yearly. By screening these 53,454 high-risk people, 62 deaths [… read more]

Dec 262011

Insurance companies, Medicare, and public health authorities haven’t yet sorted out the complexities of the survival benefit found in the Lung Cancer Screening Trial. The number needed to screen to prevent a death was ~300; ~40% of patients had at least one false positive scan, 95% were false positives overall, and overdiagnosis was very likely [… read more]

Dec 262011

Medications are often stopped during transfers of care. Bell et al analyzed administrative-level data for almost 400,000 hospitalizations in Ontario, Canada, as well as 90-day follow-up outpatient prescription data. They conclude that medications were likely to be discontinued after discharge from the hospital or ICU, “potentially unintentionally.” Five medication classes were analyzed (inhalers, anticoagulant/antiplatelets, acid-suppressors, thyroxine [… read more]

Dec 262011

The Institute of Medicine has issued stern new guidelines on guideline development. Apparently a good portion of the 2,700 clinical practice guidelines in the Agency of Healthcare Research and Quality’s database are not based on a foundation of good evidence, do not acknowledge when the evidence is shaky, and their authors often have financial conflicts [… read more]

Dec 222011

Neither a large 2009 multicenter study nor a 2011 meta-analysis showed any clinical benefit from the use of ICU telemedicine. Lilly et al report the results of a large single-center study in which they progressively implemented ICU telemedicine among 6,290 patients in 7 ICUs (a stepped-wedge design), with non-telemedicine groups acting as controls at each [… read more]

Dec 022011

Faced with steadily rising costs of medical care insurance, more and more U.S. employers are insisting that smokers pay a higher share of the premiums of their employer-sponsored insurance, according to a Towers Watson survey of 248 businesses.  19% of companies with >1,000 employees have increased smokers’ share of medical care insurance premiums, double the rate from [… read more]

Nov 132011

Research suggests e-cigarettes (those smokeless, cigarette-like nicotine delivery devices sold at convenience stores and elsewhere) can help people quit smoking, or at least dramatically cut back. So why does the FDA have a hatchet out for e-cigarettes — first trying to block their sale and distribution as illegal marketing of a drug delivery device — [… read more]

Nov 062011

Doctors are generally lousy at predicting death in terminally ill patients, and in ICU patients with indeterminate outcomes. Mortality prediction models have proliferated to improve our performance, but in the critical care literature, have mostly shown high predictive accuracy only at the tail ends of probability (high probability of survival or death). Siontis et al (led [… read more]

Nov 022011

A nice pro/con soundoff between Gerard Silvestri (con) and James Jett & David Midthun (pro) over whether lung cancer screening with chest CT should be national policy, in the wake of the positive findings of the National Lung Screening Trial. Silvestri (of MUSC) argues that we don’t have a handle on the harms of screening [… read more]

Nov 012011

25% of smokers undergoing chest CT have incidentally discovered pulmonary nodules. As questions of national policy re: lung cancer screening with chest CT are considered, Soylemez Wiener et al report the complication rates of 15,865 adults who had transthoracic needle biopsy of a pulmonary nodule in 4 states over the past decade, using a database [… read more]

Oct 312011

Poor people have higher rates of obesity. There are those who believe that’s because the poor lack self-control and discipline, overeating when they should be pulling themselves up by their bootstraps. That hard-core personal responsibility ethic is hard to refute, maybe because it contains a grain of truth, maybe because it lets all us non-poor [… read more]