Policy, Ethics, Education Archives - Page 5 of 9 - PulmCCM
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Policy, Ethics, Education Articles

Feb 172012
 
Tobacco warnings, free speech, and "in-activist" judges (NEJM)

Legal eagle Kevin Outterson explains the latest twists in the saga of the FDA’s quest to get large, scary pictures on every cigarette package under its new regulatory muscle of the 2009 Obama-authorized Tobacco Control Act. R.J. Reynolds sued, and federal judge Richard Leon took their side in November 2011, deciding to apply the more [... read more]

Feb 162012
 

Do you conduct original investigations in respiratory medicine? Are you tired of publishing your work in The New England Journal of Medicine, Science and Nature? Well, Lancet has been feeling left out. They’d like to publish your manuscript(s) in a September 2012 issue to coincide with the European Respiratory Society meeting. They’ve issued a call for [... read more]

Feb 112012
 

My post featured on KevinMD: Obama health reform adviser Ezekiel Emanuel has been writing regularly in the lay and medical press to soften up physicians and the public for the coming of the mysterious accountable care organizations. But are rank-and-file docs buying the party line? Will physicians buy into ACOs? (KevinMD) http://www.kevinmd.com/blog/2012/02/physicians-buy-acos.html

Feb 102012
 

The Cochrane Collaboration smells a rat around Pharma’s handling of its data on oseltamivir (Tamiflu) and zanamivir (Relenza). They’re taking the unusual step of publicly calling for Roche (Tamiflu) and GlaxoSmithKline (Relenza) to make available their data from the original clinical studies that led to approval of the two blockbuster drugs. They point out that [... read more]

Feb 082012
 

One-third of smokers try to quit each year, but few stay quit. Even with varenicline (Chantix), the most effective smoking cessation aid to date, only 10% are abstinent at one year. Anne Joseph, Steven Fu, Dorothy Hatsukami et al wonder if that’s partly because our (fee-for-service-driven) intermittent-visit model of patient care and counseling leaves craving [... read more]

Jan 292012
 

The Obama administration is about to mandate strict new reporting requirements that will, in effect, require that every gift to a doctor from a pharma or device company be recorded on a publicly accessible government website. This initiative was authorized in the federal health care law, but the details were unspecified and implementation delayed.  Senators Charles Grassley [... read more]

Jan 082012
 
Elderly critically ill who survive ICU rationing live well (CHEST)

Many argue that as a limited resource serving unlimited needs, medical care is “rationed” by definition, and ICU resources (being more limited and expensive) are simply more overtly rationed. For example, in France, ICU admission is often denied to the very elderly critically ill, explicitly because of their age (this happens in the U.K., too, probably). In the U.S., [... read more]

Jan 072012
 
Don't text-and-doctor, authorities warn (NYT)

Neurosurgeons making personal calls during brain surgery; intensivists shopping Amazon in the ICU; residents zoning out on rounds to check Facebook. Doctors aren’t innocent of indulging the national obsession with electronic devices while at work, and our foibles are exposed here in a fussbudget New York Times “trend” piece. There’s no real data to support the [... read more]

Jan 072012
 
Sleepy cops abound; you won't like them when they're angry (JAMA, NYT)

Did you ever wonder what that police officer is really doing while you wait forever in your car for him to write you your ticket? According to new research, it’s possible he’s taking a quick nap. And you’d best save your snarky comment when he brings you the citation: sleepy cops, it turns out, tend to be [... read more]

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
 

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 effective but often-maligned drug Chantix (varenicline) increases it to up to 33% at six months, but after a year, smoking cessation rates even with varenicline may fall to only 11% over [... 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]