Guidelines are supposed to ease the digestion by busy doctors of all the new data being crammed down their throats, but a new study in Archives of Internal Medicine suggests that doctors may one day need guidelines for the guidelines.
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Monthly Archives: January 2010
Reevaluating ESAs: too little, too late? Reply
The NEJM Perspective by 4 top FDA officials raises several questions: what was the FDA’s role in creating the current situation? And is the “reevaluation” mentioned by the FDA officials a good example of “too little, too late”?
Anyone reading the article would be hard-pressed to know that the FDA played a key role in allowing the current situation to develop. Clearly, the FDA could have played a much more pro-active role in the past and have helped prevent the current crisis. Further, the “reevaluation” mentioned by the FDA authors may not address the root cause of the problem, says at least one well-placed expert.
TREAT lead investigator Marc Pfeffer spoke with CardioBrief about the NEJM Perspective. Although Pfeffer expressed broad agreement with the need for a reevaluation, he is also troubled that not enough will be done to address the problem.
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Completion of IMPROVE-IT now delayed until June 2013 2
To the surprise of absolutely no one, the latest forecast for the completion of the long-awaited IMPROVE-IT trial has been moved back a year to June 2013. Merck announced the change, which appeared on the IMPROVE-IT page on ClinicalTrials.Gov, in a press release (below) and a FAQ.
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COMPARE investigators in the Lancet: “paclitaxel-eluting stents should no longer be used in everyday clinical practice” Reply
Everolimus-eluting stents are superior to paclitaxel-eluting stents, and the latter should no longer be used in everyday clinical practice. That’s the conclusion of the COMPARE investigators in a report published online in the Lancet. But at least one expert in the field, David Kandzari, thinks the conclusion, though justified by the data, goes beyond the simple binary choice of choosing one stent over another. (See below for his perspective.)
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FDA staff recommends against heart failure indication for Bystolic (nebivolol) 2
FDA staff reviewers have strongly recommended that Bystolic (nebivolol) not receive a new indication for heart failure. The scathing review was published on the FDA’s website in advance of next Monday’s meeting of the Cardiovascular and Renal Advisory Drugs committee.
The recommendation of the clinical reviewer was about as clear and concise as you will ever find in an FDA document:
“Approval is not recommended for nebivolol for the treatment of heart failure.”
Note to readers: CardioBrief editor to join forces with NEJM’s CardioExchange 2
Dear Reader,
I am pleased to invite you to participate in CardioExchange, an exciting new cardiology community in the early stage of development by the New England Journal of Medicine and Journal Watch.
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NEJM: FDA to reevaluate ESAs in treatment of anemia 1
The FDA plans to convene an advisory panel in 2010 “to reevaluate the use of ESAs in the treatment of anemia due to chronic kidney disease,” according to a “Perspective” written by four FDA officials in the New England Journal of Medicine.
In response to the failure of 3 large clinical trials to establish any clinical benefits for the drugs, Ellis Unger, Aliza Thompson, Melanie Blank, and Robert Temple write that although ESAs “have been widely accepted” to maintain or increase RBC levels and to avoid transfusions, “optimal hemoglobin targets have never been established.” Several trials “endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes. Unfortunately, and unexpectedly, all results have suggested the opposite.”
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Braunwald: “In all fairness, what was OK three years ago is not OK now.” Reply
A new policy from Partners Healthcare that limits compensation to doctors from industry is provoking lots of discussion (see below), at least in part because of a story in the New York Times by Duff Wilson. (Click here to read the press release Partners issued last April. Click here to read the full report.) One reason, of course, is that Partners is a major teaching affiliate of Harvard Medical School and includes top-rated Brigham and Women’s Hospital and Massachusetts General Hospital. Another reason is that the chairman of the policy-writing group was Eugene Braunwald.
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