Another Stent Device Biting The Dust

Tom Emerick

Posted 3/26/12 on Cracking Health Costs

We’re seeing a trend.  The FDA approves a stent without proper testing.  Death and complication rates with the new stent increase, the FDA is force to review it.

Remember the controversy over drug eluding stents?

According to an article in the WSJ by Thomas Burton, the so-called Stryker stent…aka the Wingspan device… is increasing rates of  death of patients who have received them.  Following protocol a panel has been convened.  According to the WSJ article, “The FDA had asked the outside panel to advise it on what to do in the wake of a large study last year showing more strokes and deaths in patients with the Wingspan device than among those whose condition was treated using drugs.”

Further, “Researchers in the study concluded the rate of stroke in the patients who got the Wingspan device was ‘substantially higher than the rates previously reported
with the use of the Wingspan stent.’ ”

This is yet another reason for patients to be cautious in agreeing to a stent, and another reason employers need to consider favoring clinics who practise strict evidence-based medicine constructs.

Calling for Field-Tested Evidence-Based Guidelines

Brian Klepper

Yesterday a nice comment arrived from Robert Gleeson MD, a new visitor to C&C, in response to the CV and lipid protocols developed by Bill Bestermann MD and David Carmouche MD.

Dr. Gleeson said,

“Outstanding. Clearly written and easily understood, evidence based, practical, applicable, designed to improve outcomes and lower costs. We need to find a way to more broadly disseminate these.

And Brian needs to find a way to get more people to submit similar protocols in similar format.”

I’m certainly game, but I’m only in the position to post these guidelines, not identify or evaluate them. So that leaves the task up to the clinicians that visit here. If you know of someone who does superlative work in an area and is willing to memorialize the protocol, by all means, please ask them to submit and, after review and validation, I’ll post for common access.

Thanks so much for the suggestion.

The Vital Role of Guideline Narratives

Kenneth Lin

Posted 12/1/11 on Common Sense Family Doctor 

A few weeks ago, I presented Family Medicine Grand Rounds at Georgetown University School of Medicine on resolving conflicts between screening guidelines. During the question and answer session, Department Chair James Welsh, MD asked how evidence from carefully conducted clinical trials can possibly overcome powerful emotional stories of “saved lives.” I answered that evidence-based medicine’s supporters must fight anecdotes with anecdotes. For every person who believes his or her life was extended by a PSA test or a mammogram, statistics show that many more are temporarily or permanently injured as a result – and their stories matter too. As blogger Kevin Pho, MD wrote about the USPSTF’s recent prostate cancer guideline, “Task Force advocates will need to put a human face on the complications stemming from prostate cancer screening” in order to convince physicians and patients that it’s okay to stop. Indeed, news stories about PSA test-related complications such as this one by Associated Press writer Marilynn Marchione will go a long way in balancing the scales.

An insightful commentary published in JAMA last month took this point one step further by asserting that narratives deployed to support evidence-based guidelines should include not only patients’ stories, but the story of the guideline developers themselves:

Continue reading “The Vital Role of Guideline Narratives”

Politics in Service of Public Health

Kenneth Lin

First published 8/1/11 on Common Sense Family Doctor

Below is the text of a proposed resolution that will be submitted by the District of Columbia Academy of Family Physicians to next month’s Congress of Delegates of the American Academy of Family Physicians in Orlando, Florida.

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WHEREAS family physicians rely on current, unbiased sources of evidence-based guidelines to select appropriate screening tests and counseling services for their patients;

WHEREAS the primary source of evidence-based prevention guidelines for family physicians is the federally-sponsored U.S. Preventive Services Task Force (USPSTF), whose recommendation statements commonly serve as the basis for AAFP clinical policies on preventive services;

Continue reading “Politics in Service of Public Health”