Dick Cheney receives an LVAD

Former Vice President Dick Cheney received a left ventricular assist device (LVAD) last week, according to reports in USA Today, the Wall Street Journal, and MSNBC. “A few weeks ago, it became clear that I was entering a new phase of the disease when I began to experience increasing congestive heart failure. After a series of recent tests and…

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GSK issues statement in response to FDA Avandia Panel

Here’s the statement:…

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Day 2 of the FDA Avandia Panel: Live Blogging the End

Meeting Adjourned. 4:33: Konstam: I don’t get him. He’s defended rosi for 2 days and then votes E. Now he votes against TIDE but says it should be cont’d. 4:29: Would love feedback from readers about this live-blogging experiment. This is my first time doing it. Fun but exhausting. Did you find it useful? Any…

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Day 2 of the FDA Avandia Panel- Live Blogging the Morning

NOON: LUNCH BREAK 11:59: Marciniak claims RECORD suffers from “differential informative censoring”– a great way to influence mortality statistics! 11:57: Marciniak says the problem in reporting events was NOT at the sites, it was from the middlemen. Says GSK tried to influence adjudication. 11:50: GSK clarifying concerns about RECORD.  Nearly all diabetes trials are open…

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Day 1 of the FDA Avandia Panel: Live Blogging the Afternoon

6:21: Kaul winds up to deliver a knock-out punch to the Nissen meta-analysis but Nissen pulls a judo move and turns the question around. Admitting his methodology and data are weak he asks: “who’s fault is it that there’s no better data?” After 11 years on the market GSK can only blame itself if there’s…

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Day 1 of the FDA Avandia Panel- Live Blogging the Morning

The afternoon will be blogged in a separate post. Lunch break until 1 PM. 12:05: Ungar: to answer the malfeasance question we may have to audit the entire trial 12:02: Kaul: Did Marciniak unearth malfeasance in RECORD? How many missing MIs in RECORD were biomarker-only or clinical events? 11:59: Ungar says he is concerned about…

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NY Times: GSK concealed negative Avandia study

Update: The Senate Finance Committee has released its letter to FDA leaders and documents it unearthed about the missing Avandia trials. GSK issued a response. GSK began a study comparing the safety of rosiglitazone (Avandia) to pioglitazone (Actos) back in 1999 and spent the next 11 years keeping the study a secret, according to a report…

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Effient and VerifyNow: a match made in heaven?

It’s like a Hollywood movie. There’s the poor boy and the poor girl who everyone knows belong together. Each can see the beauty in the other that somehow no one else in the movie can see. And by the end of the movie they hook up. A match made in heaven. And, maybe, so is…

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Handicapping the Avandia FDA panel

Journalists, bloggers and academics are weighing in on the FDA advisory panel that begins on Tuesday. The single best thing I’ve read on the hearing is by Daniel Carpenter, a professor of government at Harvard who has a new book out about the FDA: Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Carpenter’s…

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Pioglitazone beats rosiglitazone in FDA review of controlled epidemiologic studies

Avandia critics have focused on the dearth of evidence suggesting any advantage for rosiglitazone when compared to pioglitazone. They argue that there is no good reason for anyone to take rosiglitazone instead of pioglitazone. This view receives some support from the systematic review of controlled epidemiologic studies of cardiovascular risk in patients treated with rosiglitazone or…

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5 different ways of spinning RECORD

The FDA Avandia briefing document (see previous post) contains 5 separate reviews of the RECORD trial. At an FDA press briefing Janet Woodcock predicted, with perfect understatement, “there will be a long discussion of RECORD.” Thomas Marciniak, an FDA reviewer who is well-known for his skepticism, was the most critical of the trial. The other reviewers…

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FDA posts Avandia briefing documents ahead of next week’s advisory panel meeting

The FDA has posted the briefing documents for next week’s rosiglitazone (Avandia) advisory panel meeting. CardioBrief will be updating this page periodically with information gleaned from the documents. (See bottom of page for links to individual documents.)…

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Authors of JUPITER attack committed self-plagiarism

[Updated at 5:20 PM with further information about de Lorgeril and Salen] Though the titles differ slightly, a 2008 article in the Scandanavian Cardiovascular Journal by Michel de Lorgeril and Patricia Salen is identical– word for word and footnote for footnote– to an earlier article by the same authors published  in 2006 in Nutrition, Metabolism & Cardiovascular Diseases….

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NEJM editors were “not fully aware” of GSK and Merck manipulation of Avandia and Vytorin DSMBs

Prior to publication of key papers on rosiglitazone (Avandia) and ezetimibe (Vytorin) in the New England Journal of Medicine, the editors of the journal were not aware that trial sponsors had “manipulated” the Data and Safety Monitoring Boards (DSMBs) of the trials, according to information contained in an editorial in NEJM by its editor, Jeffrey…

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Study finds no benefit for tight BP control in diabetics with CAD

Target blood pressure for systolic blood pressure in people with diabetes should be below 130 mm Hg, according to current guidelines, although there is no data for diabetics who also have coronary artery disease (CAD). Now a large post-hoc analysis of INVEST (International Verapamil SR-Trandolapril Study) has found no evidence of benefit for tight blood pressure…

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Why was an Abbott marketing study published in the American Journal of Cardiology?

(Updated on July 7 with a lengthy quote from AJC editor William Roberts.) The authors call it “an in-office linguistic study” and write that it “was conducted to assess physician–patient discussions of mixed dyslipidemia.” But it’s really an Abbott marketing study for Niaspan, the company’s long-acting niacin product, and the question is: why is it published…

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Trial raises concerns over CV safety of testosterone gel

Shehzad Basaria and colleagues planned to randomized 252 men 65 years or older with limitations in mobility to testosterone gel or placebo for 6 months. The trial was terminated after enrolling 209 subjects after a higher rate of adverse events occurred in the testosterone group. The results are reported in the New England Journal of Medicine.There were…

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Prasugrel critics once again raise cancer concerns

Two critics of prasugrel have again sought to link the drug to an increased risk of cancer. The paper by  James Floyd and Victor Serebruany appears in Archives of Internal Medicine. The cancer data is taken from the detailed FDA analysis of the TRITON-TIMI 38 trial. The authors acknowledge that with the current data it…

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ACCORD analyses find a few faint glimmers of hope

New analyses of the ACCORD trial, presented at the ADA meeting and published online in the Lancet and the New England Journal of Medicine, find a few, very faint glimmers of hope amid the generally dismal results of the trial….

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Authors of JUPITER attack are members of obscure anti-cholesterol group

Two of the authors of the recent vicious attack on JUPITER published in Archives of Internal Medicine are members of an obscure, cult-like group of cholesterol skeptics. The organization,  The International Network of Cholesterol Skeptics (THINCS), is resolutely opposed to the cholesterol hypothesis. Members of the group consistently seeks to denigrate the beneficial effects of…

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Meta-analysis questions value of statins for primary prevention; JUPITER comes under attack

A new meta-analysis raises questions about the benefits of statins when given to people without a clinical history of heart disease. Kausik Ray and colleagues, in a paper in Archives of Internal Medicine, analyzed data from 65,229 subjects in 11 studies. There were 2793 deaths in the studies, 1447 among those taking placebo and 1346…

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ACC and AHA respond to boxed warning on Plavix (clopidogrel) label

Responding to the FDA’s addition of a boxed warning on the Plavix (clopidogrel) label, the ACC and the AHA have released a clinical alert intended to provide guidance to clinicians. David Holmes, Jr, the chair of the writing group, said in a press release (below) that “the majority of patients do very well with standard guideline-based…

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Tightening the noose yet again on Avandia

With the publication of two new papers Avandia appears to be caught again between a Nissen and a hard place.  In the first paper,  FDA official David Graham and colleagues analyze Medicare data and find an increased risk of heart failure, stroke, and death in elderly people taking rosiglitazone compared to those taking pioglitazone. In the…

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Once-weekly exenatide performs well in DURATION-2

In DURATION-2, presented this week at the  annual meeting of the American Diabetes Association and published in the Lancet, 491 type 2 diabetics were randomized for 26 weeks to once-weekly exenatide, sitagliptin, or piolgitazone. Exenatide treatment resulted in a significantly greater reduction in HbA1c than either sitagliptin or pioglitazone. Weight loss was also significantly greater in the…

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CHMP recommends European approval for vernakalant for recent onset AF

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for vernakalant (Brinavess, Merck, Cardiome), a novel IV antiarrhythmic agent. The approved indication is for “the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of…

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