Last month, a Medicare advisory committee provided metza metz support for sipuleucel-T, Dendreon’s prostate cancer vaccine that is  better known as Provenge. The lukewarm recommendation by the Medicare Evidence Development & Coverage Advisory Committee means that that Medicare will probably end-up paying for the treatment, but only for FDA-approved uses.

Provenge is the first cancer-fighting vaccine to be approved by the FDA. The regulatory agency green-lighted the vaccine after a key Phase III trial showed the jab increased life-expectancy in patients with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer by a median of 4.1 months and increased 3-year survival by 38%.

Those improvements come at the exceptionally steep price of $93,000 per course of therapy. By law, Medicare cannot factor-in treatment costs when deciding whether to cover a particular treatment.

The final ruling by Medicare won’t be made until next spring. It will be crucial for Dendreon, since prostate cancer strikes elderly men almost exclusively, and many of them use Medicare to insure themselves against catastrophic illness.

The committee’s decision comes at a time when governments around the world are struggling to control spiraling health costs.

In reaching its decision, the committee voted on 5 separate issues concerning the vaccine. On a 5-point scale (with 5 being high), the committee came out with an overall score of 3.6 when asked to rate their confidence in the evidence showing the vaccine improved survival.

Most casual readers would view this as lukewarm support, but Daniel Petrylak, a Provenge investigator and the co-director of the Prostate Cancer Program at Columbia concluded otherwise. “It’s clear that they believe from their voting that there is a survival benefit,” Petrylak told MedScape.

The committee was unequivocallly against the idea that Provenge should be used for non-FDA-approved (that is, off-label) indications. The committee’s average vote regarding the use of Provenge in 3 such categories ranged between 1.1 and 1.4. One of these groups was patients in whom the disease had not metastasized. That’ll cap things, at least a little.

US News & World Report’s influential “top 50” list of US hospitals is driven by subjective reputations of the institutions rather than objective measures of hospital quality, according to a study by Ashwini Sehgal of Case Western Reserve University.

To establish subjective reputations of US hospitals, US News surveys 250 board-certified physicians from around the country. US News also uses objective data including nurse-to-patient ratios, availability of specific medical technology, risk-adjusted mortality for Medicare patients, and teaching status.

In analyzing the relative contributions of subjective vs. objective measures in determining which hospitals made the coveted list, Sehgal “found little relationship between rankings and objective quality measures for most specialties.”

Specifically, he found a strong correlation between a hospital’s rank in the US News list and the hospital’s “reputation score” as measured in the survey. By contrast, a hospital’s rank was variably correlated with the objective scores used by US News.

For example, the top five heart and heart-surgery hospitals based on reputation score alone were the same as those of the US News top five heart hospitals (Cleveland Clinic, Mayo Clinic–Rochester, Johns Hopkins University, Massachusetts General Hospital, and the Texas Heart Institute).

“Because reputation score is determined by asking approximately 250 specialists to identify the five best hospitals in their specialty, only nationally recognized hospitals are likely to be named frequently,” Sehgal told MedScape. “Users should understand that the relative standings of US News & World Report’s top 50 hospitals largely indicate national reputation, not objective measures of hospital quality.”

“Being well-known may be the result of many factors that are unrelated to the quality of day-to-day care,” commented Harlan Krumholz of the Yale University School of Medicine.

The write-up is in the Annals of Internal Medicine.

Plavix, the clot-busting blockbuster marketed by BMS and Sanofi, is never out of the news for long.

One story that developed legs in the last year for example, was the finding of apparent marked variability in responsiveness to the drug. This begat calls for personalized prescribing of Plavix based on genetic markers, and warnings that Nexium-The Purple Pill—impaired its effectiveness, thus creating an increased risk of vascular complications.

Now it seems, the worm has turned again on this story. Victor Serebruany and colleagues have reported that the issue of Plavix nonresponsiveness may be caused by something rather mundane: non-compliance with the drug.

To reach this conclusion, the scientists obtained blood samples from 422 heart disease patients and 209 poststroke patients that had platelet activity tests performed before and after Plavix use.

They tested these archived blood specimens for a chemically stable, carboxyl metabolite of Plavix, and then defined Plavix noncompliance to be a very low plasma concentration of this inactive metabolite.

They found that 138 patients (22%) were in fact noncompliant. Noncompliance was more frequent in stroke victims (38%) than cardiac disease patients (14%).

“Some of the patients whom we would classically describe as ‘resistant’ to clopidogrel, in that they showed low levels of platelet inhibition, in fact didn’t actually have clopidogrel on board,” Serebruany told Medscape.

“The whole variability issue with clopidogrel (Plavix) is not such a big deal,” Serebruany added. “It has been hyped by the manufacturers of the newer antiplatelet agents. If we did studies with these agents, they would show variability, too.”

“Future antiplatelet trials should recognize noncompliance as a critical confounding factor, and every attempt should be made to minimize and strictly monitor prescribed antiplatelet regimens,” the authors concluded.