Novartis pays $422 million to settle DOJ lawsuit

Novartis has agreed to pay $422 million to settle a US Department of Justice and whistleblower lawsuit. Although many of the allegations against the company concerned the off-label promotion of the epilepsy drug Trileptal, key additional portions of the lawsuit involved the company’s cardiovascular products, including Diovan (valsartan) as well as Tekturna (aliskiren) and Exforge…

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Avandia, Meridia… now it’s Aranesp’s turn before the FDA

The FDA Death Panel Cardiovascular and Renal Drugs Advisory Committee will consider the fate of darbepoetin alfa (Aranesp) on October 18. Having failed to impose the death penalty on rosiglitazone (Avandia) and Meridia (sibutramine) in recent months, it appears likely the committee will not recommend withdrawal of the drug, though in the absence of any…

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Guest post: My Life as a Mom

Olivia

Editor’s note: The following guest post is completely off-topic and, further, completely divergent from the cynical, skeptical, and occasional misanthropic perspective usually on display here. It is written by new mom Patricia Moreno, one of the most gifted fitness instructors on the face of the earth. My Life as a Mom My daughter Olivia is…

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Guest post: news you can use: sex and your defibrillator

Editor’s Note: The following post was written by Westby G. Fisher, an electrophysiologist at NorthShore University HealthSystem in Evanston, IL and the author of Dr Wes, a popular blog about cardiology, the internet, and anything else that catches his imagination. Have a defibrillator and feel like getting frisky? For the first time that I can…

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Carotid endarterectomy still beneficial at 10 years

Carotid endarterectomy (CEA) in asymptomatic patients under 75 years of age reduces the long-term risk of stroke, according to 10-year results from the Asymptomatic Carotid Surgery Trial (ACST), published in the Lancet. The ACST investigators randomized 3120 asymptomatic patients to immediate CEA or to indefinite deferral of CEA. At 5 years, CEA had been performed…

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TCT Briefs: EES versus SES; Peripheral DES

Two more short items from the TCT meeting, reprinted courtesy of CardioExchange:…

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TCT briefs: Xience V outperforms Taxus at 2 years, ACC to co-sponsor TCT 2011

In addition to the PARTNER trial, newsworthy events from TCT on Thursday include the presentation of two trials showing the long-term superiority of the Xience V over Taxus and the surprising announcement that the ACC would be a co-sponsor of TCT 2011….

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FDA keeps Avandia on market, re-adjudicates RECORD, halts TIDE; EMA suspends Avandia marketing

The FDA announced today that it would not remove rosiglitazone (Avandia) from the market but that it would impose severe new restrictions on its use. It also put on “full clinical hold” the controversial TIDE trial. The FDA is also requiring GSK to “commission an independent re-adjudication of the RECORD study.” The new REMS will require…

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NEJM: fondaparinux effective in superficial-vein thrombosis

In a randomized, double-blind trial, 3002 patients with acute, symptomatic superficial-vein thrombosis in the legs, but without DVT or symptomatic PE, received either fondparinux (2.5 mg) or placebo for 45 days. The primary efficacy endpoint– a composite of all cause death, symptomatic PE or DVT, symptomatic extension to the saphenofemoral junction, or symptomatic recurrence of…

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PARTNER: “fundamental breakthrough” for transcatheter aortic-valve implantation

Patients with aortic stenosis who are not candidates for aortic valve replacement surgery can benefit from transcatheter aortic-valve implantation (TAVI), according to results of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial published in the New England Journal of Medicine. (The trial will also be presented at the TCT conference on Thursday.) Martin Leon and colleagues…

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FDA panel unanimously recommends approval for dabigatran

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of dabigatran (Pradaxa, Boehringer-Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both doses (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, though in an informal straw…

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Soap opera star helps BI prepare the market for Pradaxa (dabigatran)

Lucci:Afib

What can a soap opera star teach us about atrial fibrillation? Not much. But perhaps she can teach us a whole lot about pharmaceutical marketing in the 21st century. Her first lesson is about market preparation, or creating awareness and demand for a product before it’s available. In this case the product is Pradaxa, and BI…

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Guest post: A rich OASIS for Your journal club

Editor’s note: This post by Harlan Krumholz is republished with permission from CardioExchange, a new website for cardiovascular healthcare professionals from the New England Journal of Medicine. CardioBrief readers who are healthcare professionals are invited to join the site. by Harlan Krumholz I’m always scouting for papers to discuss in journal club with my students. Earlier this…

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Red light or green light for AAA screening?

Editor’s note: Last week I put up a post, Blue light special: AAA screening at Kmart in the disease-mongering aisle, that attracted some interesting and thoughtful comments. In particular, the exchange between Dan Hackam, an old online friend, and Joe Ross, a researcher who I quoted in the piece, is worthy of more attention than…

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FDA announces safety review of pioglitazone (Actos) over cancer risk

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data is taken from a planned 5 year analysis…

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FDA panel votes 9-5 against approval of lorcaserin

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 against recommending marketing approval for lorcaserin (Lorqess, Arena). Panel members were underwhelmed by the modest weight-loss efficacy of the drug, and responded to concerns raised by FDA reviewers about the incidence of cancer in rats taking lorcaserin. Some panelists also thought the sponsor had not definitively…

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Approval likely for dabigatran as FDA posts positive briefing documents for advisory panel

A positive recommendation for dabigatran appears likely based on the extremely benign briefing documents posted by the FDA in preparation for Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee. The panel will discuss the NDA for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The conclusions and recommendations of…

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TREAT Analysis: Target Dosing is Tricky

A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial, and was associated with an increase in the risk…

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FDA advisory panel refuses to put Meridia out of its misery

8 members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of withdrawing sibutramine (Meridia) from the US market. 8 members voted to keep it on the market, though all 8 agreed it needed a boxed warning and 6 thought it also should have its distribution limited to specially trained physicians. No panel…

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Blue light special: AAA screening at Kmart in the disease-mongering aisle

Now, in addition to all the other stuff  there, you can go to Kmart and get screened for abdominal aortic aneurysm (AAA). Some people will even receive free ultrasound tests. The new program, from the Find the AAAnswers Coalition, was announced on Friday. It’s a perfect example of disease mongering, the selling of a sickness…

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FDA extends review of ticagrelor (Brilinta) until December

AstraZeneca announced today that the FDA had extended the PDUFA date for its highly anticipated antiplatelet drug ticagrelor (Brilinta) for 3 months. The deadline  for a decision on the drug’s approval has therefore been moved from  September 16 to December 16. On July 28 the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor…

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FDA posts briefing documents for diet drug lorcaserin, investors get nervous

The FDA has posted the briefing documents for the September 16 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee that will consider the NDA for the diet drug lorcaserin (Lorqess, Arena). The FDA reviewers agree that the drug met the predetermined measure of efficacy, though only by a slim margin. After briefly skimming the…

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FDA posts briefing material for Meridia death panel

The FDA has posted briefing material for the September 15 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee that will consider the fate of Meridia (sibutramine), Abbot’s embattled diet drug. Two weeks ago the publication of the controversial SCOUT trial in the New England Journal of Medicine was accompanied by a strongly worded editorial…

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2 FDA rebels criticize inclusion of Avandia defenders on July advisory panel

Two FDA officials who have been highly vocal critics of Avandia (rosiglitazone) are now suggesting that the FDA stacked the deck in favor of rosiglitazone at the July advisory committee meeting by including panel members from the earlier 2007 meeting that recommended against removing the drug from the market. In a letter published in BMJ, David…

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SYNTAX at 3 years: CABG still winning, but PCI acceptable in low-risk patients

Three-year outcomes from the SYNTAX trial continue to show the overall superiority of CABG over PCI in patients with complex disease but leave room for the use of PCI in patients with low-risk disease. The results of the trial were presented by A. Pieter Kappetein at the European Association of Cardio-Thoracic Surgery annual meeting in Geneva,…

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