New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf

(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…

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Encouraging Results Found In Long Term TAVR Registry

Since it’s first FDA approval in late 2011 the use of transcatheter aortic valve replacement therapy (TAVR) has grown dramatically– but not dangerously or explosively– in the US. Now accumulating data from a central national registry provides the best picture yet of the evolution and current status of TAVR. The TVT Registry, which is run by the Society of Thoracic Surgeons (STS)…

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Novartis Heart Failure Drug Gains Approval In Europe

Entresto, the novel heart failure drug from Novartis, has now been approved in Europe. The company said the drug, a twice-a-day combination of sacubitril and valsartan (formerly known as LCZ 696), had been approved by the European Commission for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). The news follows previous approval of the drug by…

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Amgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary

CVS Health announced today that Amgen’s Repatha will be the only PCSK9 inhibitor on the CVS/Caremark formulary. This gives Amgen its first big win among the pharmacy benefits managers against Sanofi’s Praluent in the battle over the market for the powerful but expensive new cholesterol-lowering drugs. Previously Express Scripts had announced that both drugs would be placed…

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Experts Question Role For At-Home Statin Intolerance Test

A small laboratory company, Boston Heart Diagnostics, has introduced and is promoting “the first and only at-home saliva laboratory developed test” that it says will help identify people who are likely to experience side effects from taking a statin. The company claims the genetic test “helps patients understand how their bodies will process a statin…

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Amgen Takes The Pledge To Respect Patient Privacy

In response to criticism Amgen appears to have greatly tightened its corporate privacy policy regarding patient information. The company has published a “privacy pledge” to US patients” and says that it will  soon modify the authorization agreements that required patients participating in the company’s drug copay programs to surrender rights to their personal and health information. The move…

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A Few Observations About Rob Califf’s Picnic With The US Senate

I’m no expert on Washington politics but judging from the senate committee hearing today Rob Califf is going to be the next FDA commissioner. With the exception of Bernie Sanders, who had already announced his opposition, the committee members treated Califf with kid gloves. [Click here to read my live blog of the hearing.] Lamar…

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Live Blog: Senate Hearing On Rob Califf’s Nomination For FDA Commissioner

12:00 Hearing adjourned. It sure looks like Rob Califf will be our next FDA commissioner.  11:58 Scott asks about the high rate of heart disease and diabetes in South Carolina. The high cost of trials is preventing cures for these diseases. Califf asks how many hours he has to answer the question. Califf notes we have…

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Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years. In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused…

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Merck Reveals That Its 30,000 Patient CETP Trial Will Continue

Despite rumors to the contrary the story of the CETP inhibitors isn’t quite over. Merck today announced that the REVEAL trial will continue. After a series of disappointing and often spectacular failures, REVEAL is the last remaining phase 3 trial of a CETP inhibitor still underway. REVEAL is a 30,000 patient trial studying Merck’s anacetrapib. In the announcement Merck said the…

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Retiring Editor Says Its Times For Journals To Be Retired

Harlan Krumholz is not going gentle into the good night. Near the end of his tenure as the founding editor of Circulation:Cardiovascular Quality and Outcomes Krumholz has delivered a fiery editorial [PDF] arguing that the current model of printed peer-reviewed journals may not, and probably should not, survive in “a new world that is flat, digital, and…

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CMS Proposal Would Plug Up Watchman Reimbursement

Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…

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Reality Check: After Starting Warfarin One In Five Older Vets Hospitalized For Bleeding

A new study presented at the American Heart Association meeting in Orlando finds that more than one in five elderly US veterans are hospitalized for bleeding after starting warfarin. This high rate of serious bleeding complications in a real world setting surprised and even disturbed the study authors. Anticoagulants are the proverbial double-edged sword. Striking the right balance between benefit…

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SPRINT Will Change But Not Revolutionize Blood Pressure Treatment

After all the hype and hoopla it turns out that the SPRINT trial  will in all likelihood really have a significant impact on clinical practice and future guidelines, but it also also seems clear that it will not bring about a revolution, as some have recently speculated, in the treatment of high blood pressure. That’s the broad  consensus emerging from hypertension…

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Waiting For ISCHEMIA: Why Won’t Cardiologists Enroll Patients?

One of the most important unanswered questions in medicine today– the best treatment for stable ischemic heart disease– may never get a satisfactory answer because cardiologists are unwilling to enter their patients in a clinical trial. One major reason why the question is urgent: about a third of the 1 million PCI procedures performed each year in the…

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Lancet Sprints To The Front With A Blood Pressure Meta-Analysis

A new meta-analysis published in the Lancet on Friday lends fresh support to calls for more intensive blood pressure treatments. The publication comes only days before the highly anticipated presentation of the NIH’s SPRINT trial at the American Heart Association, which is also expected to offer support for stricter blood pressure control. Blood pressure goals were relaxed after the ACCORD…

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You Don’t Know It But The Debate About SPRINT Is Already Over

On Monday you’re going to hear a lot– an awful lot– about SPRINT. That’s the big NIH blood pressure trial which was stopped early. On September 11 an NIH press release trumpeted the positive results without revealing most of the important details. This Monday, finally, the results are scheduled to be presented at the American Heart…

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New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs

More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…

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Should Doctors Tell Patients They Are Walking Time Bombs?

Updated– Should doctors tell patients that they are walking time bombs? We all know this is a commonly used metaphor. When it comes to the heart people are often told they have a “ticking” time bomb. Here’s one recent very public example from a story about statins by Jane Brody in the New York Times: “My friend Richard…

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Clot Extraction For Stroke: Beware The Hype

Clot extraction (thrombectomy) for stroke has been on a roll lately. After the failure of a series of trials a few years ago investigators and industry went back to the drawing board. The result of their efforts– a new and improved thrombectomy– has brought about a dramatic reversal of fortune for the technology. In the past year five newer trials…

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Slow Start For New Novartis Heart Failure Drug Entresto

Initial sales of Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) have been slow. In the first few months after its approval in July the drug only had $16 million in sales, the drug’s manufacturer, Novartis, reported last week during its quarterly earnings report. The novel heart failure drug is widely expected to be…

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Trick Or Treat? Hospitals, Haunted By DOJ ICD Investigation, Settle For $250 Million

The specter of the US government investigation into hospital overuse of ICDs has now finally been dismissed. The investigation, which has haunted hospital executives and electrophysiologists since it began in 2011, was finally resolved on the day before Halloween. With a $250 million treat for the government the hospitals have now finally managed to get the unwelcome trick or treaters…

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Studies Suggest Flu Vaccines May Be Less Effective In People Taking Statins

Two new studies published in the Journal of Infectious Diseases offer preliminary evidence that the flu vaccine may not work as well in people taking statins. But there is widespread agreement among experts that the association, much less a demonstration of cause and effect, has not been proven, and that current clinical practice should not be changed because…

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Does Anyone Really Think Industry Funded CME Is Independent?

Does anyone really think that commercially supported continuing medical education (CME) is truly independent? Or does anyone really think that it has the primary goal of delivering quality medical education? A few weeks ago John Fauber and colleagues wrote an important story in the Milwaukee Journal-Sentinel and MedPage Today about the role of CME in helping…

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Coming Attraction: Looking Forward To SPRINT At The AHA Next Month

Back in September the NIH tantalized the medical community with a preliminary announcement of the results of a major clinical trial, SPRINT (Systolic Blood Pressure Intervention Trial). The NIH said SPRINT was a “landmark trial” that could “save lives,” but their claims were impossible to evaluate since they only gave the slightest hint of the actual results. On November…

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