Cardiologist in McAllen, Texas sentenced to 4 years in prison Reply

Fabian Aurignac, a cardiologist in McAllen, Texas, was sentenced to 4 years and 9 months in prison for defrauding Medicare and Medicare, according to a report by Jeremy Roebuck in The Monitor.

According to court filings reported by Roebuck, in a 3-week period in 2003,while he was on vacation in Argentina, Aurignac fraudulently billed Medicare and Medicaid more than $900,000.
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Shanghai cardiology conference: putting the “con” back in the word “conference” Reply

An upcoming cardiology conference in Shanghai may be putting the “con” back in the word “conference,” according to a news item in TheScientist.Com by Alla Katsnelson. The article details the confusion and difficulties, including possible credit card fraud, that resulted when cardiologists and other scientists– including well-known University of Florida cardiologist C. Richard Conti– received invitations to attend the “1st International Cardiology Congress”  in Shanghai in December.
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BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance” 3

A large observational study has found a significantly higher risk of heart failure and death associated with rosiglitazone compared to pioglitazone. David Juurlink and colleagues in Toronto, Canada state in their conclusion:

Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone, questioning whether ongoing use of rosiglitazone is justified in any circumstance is reasonable.

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Wall Street guesses ARBITER-6 will be AHA late-breaker 1

Updated (story originally published on August 17)– Wall Street analysts are speculating that ARBITER 6 will be presented as a late-breaker at this year’s AHA meeting in Orlando in November.

Wells Fargo analyst Larry Biegelsen last week wrote that “we expect the ARBITER 6 HALTS study to be presented as a late-breaker at the AHA in November 2009,” though he acknowledged that this information was “not confirmed. On Monday morning CNBC pharmaceuticals reporter Mike Huckman, who is on vacation, twittered that the Leerink Swann pharmaceutical analyst said that ARBITER 6 will be presented at the AHA.
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WATCHMAN: will it replace warfarin in some patients? (updated) 2

Updated with commentary from David Kandzari– The WATCHMAN percutaneous left atrial apendage closure device is as effective as warfarin in reducing the risk of stroke in patients with non-valvular AF, but use of warfarin is not likely to go away anytime soon, according to the publication of the PROTECT AF trial in the Lancet and an accompanying comment.
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Cardio-Sis in the Lancet: is 130 the new 140? Reply

Cardio-Sis, a large trial from Italy, provides the first good evidence that systolic blood pressure goals in non-diabetic patients should be lowered to 130 mm Hg. Most guidelines now recommend that systolic blood pressure be reduced to below 140 mm Hg, though in diabetics it is now generally accepted that the target should be 130 mm Hg. The findings are published today in the Lancet.
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NEJM: Califf et al shed light on the SEAS controversy Reply

Are there important lessons to be learned from the ezetimibe cancer controversy? Almost exactly a year after an increased cancer risk with ezetimibe was found in the SEAS trial, the Duke investigators who were at the eye of the ensuing storm have made several recommendations for changing the way information is handled in major clinical trials. The paper by Robert Califf, Robert Harrington, and Michael Blazing appears in a special article in the New England Journal of Medicine.
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“This has not been a well managed review process” –FDA official on prasugrel approval 1

A month after approving prasugrel the FDA has released some, but not all, of the documents it is required to post on its website. According to knowledgeable observers, the full action document has not yet been released.

CardioBrief has not reviewed these documents in detail, but noticed a few items that might be of interest to readers:

Norman Stockbridge, director of the division of cardiovascular and renal products, states what has long been obvious to almost anyone observing the approval process:

This has not been a well managed review process. The issues were pretty clear early enough to have allowed us to meet the original PDUFA goal. What has been missing is a clear means or will to declare an end to discussions and to allow the regulatory process to complete. No one associated with this review should feel good about this.[p 5, Division Director Memo]

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Large study increases concerns over TZD fracture risk Reply

Both men and women who take thiazolidinediones (TZDs) may be at increased risk for fractures, according to a large new prospective cohort study published in the Archives of Internal Medicine.

Colin Dormuth and colleagues studied nearly 85,000 patients in British Columbia who began treatment with a thiazolidinedione or a sulfonylurea. They found a 28% increased risk of peripheral fractures in both men and women among patients who took TZDs compared to those who took sulfonylureas.
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Antioxidant supplements (round 3): Harrington remains “naturally skeptical” 3

Bob Harrington has told CardioBrief that he remains skeptical of claims that antioxidant supplements can prevent damage from radiation exposure.

In response to our initial story last week reporting that UCLA’s Matthew Budoff had endorsed a patented nutritional supplement “designed to neutralize the damaging free radicals produced by medical x-rays,” we quoted an alternate, highly skeptical perspective from Duke’s Bob Harrington. In a subsequent post, and in lengthy comments attached to the post, James Ehrlich, a board member of the company behind the pill, defended the pill and implied that in private correspondence Harrington had modified his position.

In his new statement to CardioBrief, Harrington has reaffirmed his original position. Here is his statement:
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Questions raised about UCLA cardiologist’s endorsement of nutritional supplement 1

Matthew Budoff, a well-respected UCLA cardiologist best known for his strong advocacy of coronary calcium screening, has endorsed a patented nutritional supplement, BioShield-Radiation R1, “designed to neutralize the damaging free radicals produced by medical x-rays,” according to a press release from the supplement’s manufacturer, Premier Micronutrient Corporation. The press release states that Budoff “has become the first cardiologist in California to offer patients” the new pill.

But Duke’s Bob Harrington tells CardioBrief that the claims of the company for the supplement are unsubstantiated: “The whole thing is smoke and mirrors. Show us some data!”
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Prasugrel finally hits the street 2

Prasugrel is now available in pharmacies in the US, according to a press release issued by Lilly and Daiichi Sankyo.

Click here to read the press release.

Click here for a complete chronology of the prasugrel controversy.

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Pitavastatin prescribing information released by FDA Reply

The FDA has released prescribing information for pitavastatin, the newest statin on the US market approved yesterday. Pitavastatin appears to be as effective as atorvastatin and somewhat more effective than simvastatin in lowering cholesterol. However, the prescribing information contains no information or data about long-term clinical outcomes with pitavastatin.
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New review bolsters evidence for benefits of fish oil Reply

A new review of previously published studies finds compelling evidence that omega-3 fatty acids from fish or fish oil supplements are effective in secondary prevention. The new study is published in the Journal of the American College of Cardiology.

“This isn’t just hype; we now have tremendous and compelling evidence from very large studies, some dating back 20 and 30 years, that demonstrate the protective benefits of omega-3 fish oil in multiple aspects of preventive cardiology,” said Carl Lavie, medical director of Cardiac Rehabilitation and Prevention, Ochsner Medical Center, New Orleans, LA, and lead author of the article, in an ACC press release. “The strongest evidence of a cardioprotective effect of omega-3s appears in patients with established cardiovascular disease and following a heart attack with up to a 30 percent reduction in CV-related death.”
Click here to read the ACC press release…