The ACC has gone into full battle mode to fight proposed CMS cuts to reimbursement for cardiology services.
ACC CEO Jack Lewin writes in his blog: “We have been rocked by this proposal and now it’s time to roll!” But the ACC appears to be more in a mood to “lock and load” than “rock ‘n roll.” According to a special edition of the ACC Advocate newsletter, the CMS proposal could results in cuts of 30% or more for many cardiology practices.
The FDA has approved prasugrel (Effient) to reduce the risk of MI in ACS patients undergoing PCI. Lilly had hoped to claim a broader indication for the drug.
The drug’s labeling will include a boxed warning alerting physicians that the drug can cause significant, sometimes fatal, bleeding, according to the FDA press release. “The drug should not be used in patients with active pathological bleeding, a history of mini-strokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.”
Click here to download a PDF of the label.
Click here for a complete chronology of the prasugrel controversy.
Click here to read press releases from the FDA and from Lilly/Daiichi Sankyo…
The FDA has admitted to Congressman Maurice Hinchey that Sanjay Kaul was wrongly excluded from the February advisory board meeting on prasugrel. CardioBrief first reported Kaul’s absence. (Click here for a complete chronology of the prasugrel controversy.)
Hinchey issued a press release which contains little new information. To date the FDA has refused to shed light on the specific details of Kaul’s disinvitation, besides acknowledging that staff members who lacked proper authority acted after being contacted by representatives from Lilly.
One of the most powerful images of modern times is of Winston Smith, the anti-hero of George Orwell’s dystopian novel 1984, rewriting history for the totalitarian regime he serves by dropping original but no longer convenient documents into the “memory hole” of an incinerator.
Now the editors of JAMA appear to have adopted Winston Smith as their role model. An earlier version of an editorial that had been published online has now been removed from the JAMA website, in stark defiance of the rules and ethics of medical and scientific publishing.
CMS has added 30-day readmission data for MI and heart failure to its Hospital Compare website, in addition to previously available mortality data. A startling finding from the new data is an unexpectedly high 19.9% readmission rate for MI and a 24.5% rate for heart failure.
Another important change to the website this year is in the way CMS calculates mortality data. Previously Medicare used one year of claims data to compute mortality, while now mortality rate encompasses 3 full years of claims. The 3 year mortality data is 16.6% for MI and 11.1% for heart failure.
Click to continue reading, including press releases from CMS and the AHA…
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Click here to see all of CardioBrief‘s coverage of ARBITER-6
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Updated with clarifications from Allen Taylor, Abbott, and Schering-Plough– ARBITER 6-HALTS, a trial comparing ezetimibe to extended-release niacin in 400 patients already taking statins, has been terminated early by an independent steering committee. According to a statement entered on June 16, 2009 on the trial’s page on the clinicaltrials.gov website, the early halt of the trial was “based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns.”
News of the early termination was first reported today by Peter Loftus on DowJones Newswires. The trial was sponsored by Abbott and the Walter Reed Army Medical Center. Allen Taylor, who recently moved from Walter Reed to the Washington Hospital Center, is the principal investigator.
Radiofrequency catheter ablation is increasingly being used to treat atrial fibrillation, but there is little known about its long-term effects, according to a new comparative effectiveness study from the Agency for Healthcare Research and Quality (AHRQ).
The study finds good evidence that RF ablation helps keep the heart in sinus rhythm up to one year, but found little evidence for longer-term efficacy. “Radiofrequency holds promise for treating atrial fibrillation, but it is clear that more research is needed to demonstrate its potential long-term benefits,” said AHRQ Director Carolyn Clancy, in a press release. “This report crystallizes the questions that researchers need to ask going forward.”
Click to read the AHRQ press release…
Should physicians adhere to ACC/AHA guidelines? In response to a February report in JAMA by Pierluigi Tricoci, Robert Califf, and Sidney Smith (which we wrote about here) discussing an explosion in ACC/AHA guideline recommendations despite the lack of a solid evidence base, letter writers in JAMA have continued the debate over the value of ACC/AHA guidelines. A major target of the letter writers is an editorial by Terrence Shaneyfelt and Robert Centor that accompanied the report and argued that “clinicians and policy makers must reject calls for adherence to guidelines. Physicians would be better off making clinical decisions based on valid primary data.”
Elliott Antman and Raymond Gibbons, past chairs of the ACC/AHA Task Force on Practice Guidelines, are especially critical of the editorial. They note that “although an average of 50% of recommendations in ACC/AHA guidelines are based on evidence level C (expert consensus), the conclusion by Shaneyfelt and Centor that all of these recommendations reflect subjective bias was not justified. Many recommendations are based on sound clinical judgment that will never be tested in a clinical trial (eg, obtaining a 12-lead electrocardiogram in a patient presenting to the emergency department with chest pain).”
Click to continue reading…
In the latest episode in the ongoing saga that started as a simple report of a missing conflict of interest disclosure in a JAMA paper, JAMA editors Catherine DeAngelis and Phil Fontanarosa have released an updated and far less contentious version of an editorial that was originally published in March. [Please note that the March document has been removed from the JAMA site. This link is an archived copy.] It appears the pitbulls of March have been tamed and have now become the lapdogs of summer.
Although the JAMA editors and the AMA are not speaking about the issue, a statement from the AMA (see below) offers the strong suggestion that the revisions to the JAMA editorial were strongly influenced by the dog whistle of the AMA’s Journal Oversight Committee. Click to continue reading…
(Updated)–Here is a chronology of the JAMA editors controversy:
May 28, 2008
Initial publication in JAMA of “Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial.” JAMA. 2008; 299(20): 2391-2400. Robert G. Robinson is the first author.
The H2-receptor antagonist famotidine is effective in reducing the risk of ulcers and erosive esophagitis in patients taking low dose aspirin, according to results of the FAMOUS trial published online in the Lancet.
British researchers randomized 400 patients taking aspirin 75-325 mg per day to either famotidine or placebo. At 12 weeks patients underwent endoscopy. Gastric ulcers were found in 3.4% of famotidine patients compared to 15% of placebo patients, duodenal ulcers in 0.5% of famotidine patients compared to 8.5% of placebo patients, and erosive esophagitis in 4.4% of famotidine patients compared to 19% of placebo patients.
The authors note that the rising use of low dose aspirin and other antithrombotic strategies has caused an increase in upper GI complicatins. Although PPIs are often employed, the authors note “concerns about their costs, safety, and risk of interaction with clopidogrel.”
Click here to read the Lancet press release…
Hypertension pioneer John Laragh, who developed the renin hypothesis and who founded the American Society of Hypertension and its journal, and who later split with the society in a bitter public dispute (you can read all about the controversy by searching for “Laragh” on TheHeart.Org), is now proposing a treatment approach to hypertension that diverges dramatically from current standards.
Laragh and his wife and colleague, Jean Sealey, and other colleagues compared the renin test-guided therapeutic (RTGT) algorithm to standard therapy in 85 treated but uncontrolled hypertensive patients. The Laragh method relies on a plasma renin activity assay to assign hypertension patients into sodium-volume excess “V” hypertension or renin–angiotensin vasoconstriction excess “R” hypertension. The study is published in the American Journal of Hypertension.
After looking at the study CardioBrief asked Laragh and Sealey a few questions. They responded in great detail, and have allowed their remarks to be reprinted. Here is the exchange:
Click to continue reading…
Earlier this week the Institute of Medicne released its recommendations of priority topics for the American Recovery and Reinvestment Act of 2009 focus on a new national investment in comparative effectiveness research. Here is a link to the full report.
Here are the topics that specifically involve cardiovascular medicine. Click to continue reading…
Following a contentious FDA advisory panel meeting and considerable discussion about the ultimate clinical role of the drug, dronedarone (Multaq) has finally been approved by the FDA for the treatment of atrial fibrillation or atrial flutter. Sanofi-Aventis said it planned to launch the drug this summer.
According to the FDA, the drug’s label will contain a boxed warning, the FDA’s strongest warning, cautioning that the drug should not be used in severe heart failure patients.
Even patients who are already on statin therapy will benefit from an acute statin reload prior to PCI, according to the results of ARMYDA-RECAPTURE, published online in the Journal of the American College of Cardiology. Previous ARMYDA studies had shown the benefits of atorvastatin in statin-naive patients prior to PCI.
The Italian investigators randomized 383 patients undergoing PCI to placebo or atorvastatin reload (80 mg 12 hours prior to PCI, followed by a 40 mg dose immediately prior to the procedure). At 30 days MACE was reduced from 9.4% in the placebo group to 3.7% in the atorvastatin reload group. Reduction in periprocedural MI was responsible for most of the difference. The benefits of reload occurred predominantly Click to continue reading
The FDA is adding boxed warnings about serious mental health events to prescribing information for varenicline (Chantix) and buproprion (Zyban, Wellbutrin, etc).
“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a FDA press release. Woodcock said physicians should monitor patients taking these drugs for any unusual changes in mood or behavior.
The FDA will require the drugs’ manufacturers to conduct a clinical trial “to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies.”
Click for commentary from Melissa Walton-Shirley and press releases from the FDA and from Pfizer…
