FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug 1

Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year.

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection (proposed trade name Reasanz) from Novartis.

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What To Expect At The American College of Cardiology Meeting Reply

The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly-anticipated late-breaking clinical trials.

On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation….

 Click here to read the entire post on Forbes.

 

12.8 Million More Adults Now Eligible For Statin Therapy Reply

Millions more people are now eligible for statin therapy under the new cholesterol guideline, according to a new estimate published in the New England Journal of Medicine.

There have been many attempts to quantify just how many more people are now eligible for statin therapy under the new guideline. Now in the new paper in NEJM, Michael Pencina and colleagues estimate that the new guideline results in a net increase of 12.8 million people who are now eligible for statins.

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Studies Provide Little Support For Guidelines On Dietary Fats And Supplements Reply

The precise cardiovascular effect of dietary fats and supplements has been the subject of heated controversy. Although there is no strong supporting evidence from clinical trials, current guidelines tend to discourage or minimize the role of saturated fats and trans fats and to encourage the intake of omega-3 polyunsaturated fatty acids. Two new studies published today help clarify some of the issues. Both studies demonstrate the shaky underpinnings of the guidelines but are unlikely to provide firm support for a new perspective on these issues.

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Phase 4 Actelion Study Misses Primary Endpoint Reply

Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint.

The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the effect of bosentan on the time to first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) already receiving treatment with sildenafil.

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Reassuring News About Statins From Two Very Different Studies Reply

Although clinical trials have consistently demonstrated the benefits of statins, the perception that the drugs can cause serious side effects has prompted some patients to discontinue or not take the drugs. Now two new very different studies, one a large meta-analysis and one a tiny study with only a handful of patients, provide some convincing reassurance that most of the side effects that have been tied to statins do not appear to be actually caused by the drugs.

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Apixaban Gains Indication For DVT Prophylaxis After Knee And Hip Replacement Surgery Reply

The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery. DVT can lead to the life-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have nonvalvular atrial fibrillation.

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US Patients More Likely Than English Patients To Receive Life-Saving Surgery Reply

Patients with a ruptured abdominal aortic aneurysm (rAAA)– a very serious life-threatening illness that occurs more often in elderly men– have better outcomes in the United States than in England, according to a new study published in the Lancet.

Researchers at the University of London compared hospital data from 11,799 rAAA patients in England with 23,838 rAAA patients in the U.S. They found that U.S. patients were more likely than English patients to have a procedure to repair the rAAA and to survive their hospital stay.

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Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials Reply

Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of  prominent cardiovascular and diabetes researchers.

It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. Now, however, that belief is no longer widely held and the FDA now requires cardiovascular outcome trials for new diabetes drugs. But, write the researchers in  an article published in The Lancet Diabetes & Endocrinology, these trials are failing to track and analyze one key cardiovascular endpoint, thereby diminishing the value of these trials in assessing the cardiovascular effects of diabetes drugs.

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French Surgeons Perform First Aortic Valve Surgery Without Opening The Chest Reply

Surgeons in France report that they have performed the first total endoscopic aortic valve replacement (TEAVR) in 2 human patients. Their paper has been published in the the Journal of Thoracic and Cardiovascular Surgery [subscription required].

The new procedure may enable surgeons to replace the aortic valve without opening the chest, though it will still require cardiopulmonary bypass and excision of the old valve. The key to the new procedure is the recent availability of sutureless aortic valve bioprostheses, in this case  the Medtronic 3f Enable bioprosthesis. In recent years these devices have allowed surgeons to develop “minimally invasive” surgical techniques. The new report is about the first surgical procedure in which the chest is not opened and the procedure is performed entirely through endoscopes.

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Cardiologist Tapped To Run The Smithsonian Institution Reply

A cardiologist has been chosen by its Board of Regents to be the next leader of the Smithsonian Institution.  David Skorton, who is currently the president of Cornell University, will be the Institution’s 13th Secretary, effective July 2015. He will be not only the first cardiologist but the first physician to run the Smithsonian.

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English: The Smithsonian Building in Washingto...

FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade Reply

In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs.

Last month Regeneron disclosed that it had been “advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class.”

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What Ails Mt. Sinai Hospital Ails The Entire US Healthcare System 1

Bloomberg News article raises extremely troubling questions about policies and procedures that have made the Mt. Sinai hospital catheterization laboratory the busiest and most lucrative in New York City. It is unclear whether the specific allegations in the article will stand up to rigorous scrutiny but, say some experts, the ills identified in the article go far beyond Mt. Sinai and New York City and are actually endemic throughout the entire US healthcare system.

The most explosive charge in the story by David Armstrong, Peter Waldman and Gary Putka is that hospital physicians scheduled emergency room appointments for patients lacking insurance and coached them to say they were having symptoms of an acute coronary syndrome….

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Samin Sharma (Wikimedia Commons)

Samin Sharma (Wikimedia Commons)

Aegerion Warns About Negative Impact Of DOJ Investigation Reply

Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid (lomitapide) is a cholesterol-lowering drug indicated for the rare condition of homozygous familial hypercholesterolemia. It sells for $250,000 a year.) Now the company reports that by running “a corrective advertisement on CNBC” and by reviewing additional promotional material  it believes it will be able to resolve its problems with the FDA.

But the DOJ investigation may prove to be a bigger and more serious problem….

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4 Deaths Linked To Thoratec Heart System Reply

Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary system controller to their backup system controller.”

The company said that 8 of the 9 events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller….

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HeartMate II

 

 

Warfarin Benefits Extended To Patients with Chronic Kidney Disease Reply

Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD. Now, a large observational study offers some reassurance that anticoagulation in AF patients with CKD may be beneficial.

Researchers in Sweden analyzed data from more than 24,000 survivors of acute myocardial infarction who had AF….

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Heart Societies Issue New Guidelines For Valve Disease Reply

The American Heart Association and the American College of Cardiology today released new practice guidelines [PDF] for the management of patients with valvular heart disease (VHD). Among its most notable features, the new document provides a new system of classification for VHD and lowers the threshold for interventions, including, for the first time, transcatheter as well as surgical interventions.

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Pfizer Starts Testing For Over-The-Counter Lipitor Reply

Looking backward to improve its future, Pfizer will once again try to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reports in the Wall Street Journal that the company has started a clinical study to support the application for low-dose atorvastatin (10 mg).

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Tooth Extraction Prior to Cardiac Surgery May Not Be a Good Idea Reply

People with an infected or abscessed tooth are at elevated risk for cardiovascular disease. They are at particular risk for developing a serious infection during surgery, including endocarditis, a potentially life-threatening infection of the heart. Because of this risk, in order to reduce the chance of infection, many patients undergo dental extraction prior to having a planned cardiac surgery. Now, however, a new paper published in The Annals of Thoracic Surgery raises the possibility that prophylactic dental extraction may be far more risky than previously thought.

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Steve Jobs Rejected The First Medical App In 1977 Reply

There’s been a lot of speculation that future Apple products will include health-related apps and biometric sensors. Here’s the story of what might have been the first Apple medical app, except for the fact that in 1977 Steve Jobs had absolutely no interest in going in that direction.

George Diamond is now retired after a long and very distinguished career as a cardiologist at Cedars-Sinai Medical Center in Los Angeles. But in 1977 he was just starting his career at Cedars, where he was working on cutting-edge devices and statistical methods to improve the diagnosis of heart disease (a major problem that even today is far from being solved).

So I picked up the telephone and called Apple in Cupertino. I told the secretary that I wanted to speak with somebody about a medical application for the Apple II computer. The secretary connected me directly to Steve Jobs. (Of course I didn’t know who he was. I didn’t even recognize the name as being one of the people who had actually invented the thing.)

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George Diamond today

Study Raises Questions About Transfusions In PCI Patients Reply

A very large observational study raises important questions about the role of transfusions in PCI patients in the US.

In a study published in JAMA, researchers from Duke and Yale analyzed data from more than 2.25 million percutaneous coronary intervention (PCI) procedures at more than 1,400 hospitals. The data came from the CathPCI Registry, a large ongoing study that includes  a significant proportion of all cardiac catheterization procedures in the US.

The overall transfusion rate was 2.14% but there was a very wide variation in transfusion practice patterns, ranging from 0 to 13%….

….

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FDA Approves New Catheter For Treatment Of Atrial Fibrillation Reply

The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in patients with drug-resistant paroxysmal atrial fibrillation (AF), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter. The device is manufactured by Biosense Webster, a Johnson & Johnson company.

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Vitamin Supplements Come Up Short Once Again 1

Once again the U.S. Preventive Services Task Force (USPSTF) has concluded that there is no good evidence to support the routine use of multivitamins or most individual or combination vitamins by healthy adults to prevent cardiovascular disease or cancer.

The USPSTF also recommended against the use of two specific vitamins — beta-carotene and vitamin E. Beta-carotene has been linked to a significant increase in the risk for lung cancer among smokers, while “a large and consistent body of evidence has demonstrated that vitamin E supplementation has no effect on cardiovascular disease, cancer, or all-cause mortality.”

For other vitamins or multivitamins, the task force found few significant harms, though they said the evidence was insufficient to allow definitive assessments of the risks and benefits.

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Lower Blood Pressure Found In Vegetarians Reply

A new study provides the strongest evidence yet that a vegetarian diet is strongly associated with lower blood pressure. Although various health benefits of a vegetarian diet have often been proposed, a rigorous examination of the effect on blood pressure has not been previously performed.

In a paper published in JAMA Internal Medicine, Japanese researchers analyzed data from 7 clinical trials, including 311 participants, and 32 observational studies, including 21,604 participants….

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Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong Reply

In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device companies to use sham procedures when they test certain new products. To support his argument he uses the example of renal denervation, a once highly promising new technology for lowering blood pressure. Unfortunately, Gottlieb extracts exactly the wrong lesson from this story, because the renal denervation story is a perfect example of why sham procedures can be both necessary and more ethical than any alternative.

At first glance it’s hard to disagree with Gottlieb. The idea that patients would receive an invasive surgical procedure that could do no good appears abhorrent. “Research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans,” writes Gottlieb.

But the same exact words could and should be used to describe medical devices with no proven benefit. In such cases, however, instead of the relatively small number of patients potentially exposed to harm in clinical studies, the number of patients exposed to harm in the real world may be larger by many orders of magnitude.

Let’s examine this issue using the same example used by Gottlieb: renal denervation….

Click here to read the full post on Forbes.