Cardiology Drugs Of The Year: New, Old, And Not-So-Funny 1

New Drug Of The Year: LCZ696 from Novartis

Old Drug of the Year: Ezetimibe

Not-So-Funny Drug of the Year: Ivabradine

Click here to read the full post on Forbes.

 

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Embattled Stem Cell Researchers Sue Harvard And Brigham And Women’s Hospital Reply

Two embattled and highly controversial stem cell researchers are suing the Brigham and Women’s Hospital and Harvard Medical School for an ongoing investigation into their research. The investigation has already resulted in the retraction of one paper in Circulation and an expression of concern about another paper in the Lancet.

The suit was filed by Piero Anversa, the highly prominent stem cell researcher who is a Harvard professor and the head of a large lab at the Brigham, and his longtime colleague, Annarosa Leri, an associate professor of medicine at Harvard who has coauthored many papers with Anversa. The suit places the blame for any scientific misconduct relating to the two papers on a third colleague and coauthor, Jan Kajstura, their longtime collaborator.

Click here to read the full post on Forbes.

 

Continuing Medical Education Payments To Physicians Will Be Exposed To Sunshine Reply

After a long and complicated struggle it now appears highly likely that industry will be required to disclose payments to physicians for continuing medical education (CME). This decision from CMS, which I am told by reliable sources is final, follows a long period in which CMS appeared to waver in its approach to incorporating CME into the Sunshine Act.

Click here to read the full post on Forbes.

 

No Advantage For Low Glycemic Index Diet Reply

In recent years the glycemic index (GI), a measure of a carbohydrate’s impact on blood sugar, has assumed a major role in discussions about diets and nutrition. Now a new study suggests that by itself, within the context of an otherwise healthy diet, GI may not be an important factor in improving cardiovascular risk.

In a paper published in JAMA, Frank Sacks and colleagues report the results of a randomized, crossover-controlled 5-week feeding trial comparing 4 different diets in 163 overweight or obese adults. The diets were either low- or high-carb and either low- or high-GI. Importantly, all the diets were based on previously established healthy dietary patterns based on the DASH diet, which is low in saturated and total fat and includes substantial amounts of fruits, vegetables, and low-fat dairy foods.

Click here to read the full post on Forbes.

 

Get Rid of Sugar, Not Salt, Say Authors Reply

Too much negative attention has been focused on salt and not enough on sugar, write two authors in Open Heart. Reviewing the extensive literature on salt and sugar, they write that the adverse effects of salt are less than the adverse effects of sugar. The evidence supporting efforts to reduce salt in the diet is not convincing and we would be far better off reducing sugar instead of salt in the modern diet.

Click here to read the full post on Forbes.

 

English: Macro photograph of a pile of sugar (...

European Review Confirms Increased Risk with Ivabradine Reply

Following a review provoked by troubling findings that emerged from a large clinical trial, the European Medicines Agency (EMA) is making several recommendations intended to lower the risk of heart problems linked to the heart-rate-lowering drug ivabradine. The drug is marketed by Servier in Europe under the brand names of Corlentor and Procoralan and is indicated for the treatment of heart failure and stable angina. The drug is not available in the U.S. but is under development by Amgen for the indication of heart failure.

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IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe Reply

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo or that LDL might not be a reliable surrogate endpoint. The IMPROVE-IT results will also provide comfort to companies developing the next generation of cholesterol drugs, since their approval may have depended on validation of LDL as a surrogate endpoint.

The  Improved Reduction of Outcomes: Vytorin Efficacy International Trial, presented Monday morning at the American Heart Association meeting in Chicago, randomized 18,144 high-risk patients within 10 days of an acute coronary event to either ezetimibe or placebo on top of a statin….

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Cannon

At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs 1

There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the McCormick convention center.

Click here to read the full post on Forbes.

Amgen Door Hanger

 

IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine 1

The presentation of the eagerly awaited IMPROVE-IT trial, scheduled for Monday at the American Heart Association meeting, won’t be accompanied by a simultaneous publication in the New England Journal of Medicine. Although no one except for a small group of insiders knows for sure, this news may have important implications.

Click here to read the full post on Forbes.

 

Popular Diets Achieve Only Modest Long-Term Weight Loss Reply

Four of the most popular current weight loss diets produce at best only modest long-term benefits, a new study published in Circulation: Cardiovascular Quality and Outcomes shows. The study also found few significant differences across the four diets, offering little hope that any one diet can produce a serious dent in the obesity epidemic.

Mark Eisenberg and colleagues systematically searched the literature for studies evaluating the effects of the Atkins, South Beach, Zone, and Weight Watchers diets. They identified 12 randomized, controlled studies with follow-up of at least 1 year. Ten studies compared one of the diets with usual care. In these trials, Weight Watchers was the only diet to consistently outperform usual care in achieving weight loss, but this difference was modest at best, yielding a 1-year weight loss range of 3.5 to 6 kg with Weight Watchers compared with 0.8 to 5.4 kg with usual care. In the two head-to-head trials, Atkins and Zone resulted in a similar but modest weight loss. Longer-term data out to 2 years — available only for the Weight Watchers and Atkins diets– showed that some of the original weight loss was regained over time. Only one small trial studied the South Beach diet.

Click here to read the full post on Forbes.

 

What You Need To Know About IMPROVE-IT Reply

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing the end of its patent life the commercial significance is somewhat limited. However, IMPROVE-IT will also have very important implications beyond its specific effect on one drug franchise and could influence the fate of several new drugs now being investigated and may even alter the entire drug development and evaluation process.

Here’s some background information and links to useful resources.

Click here to read the full post on Forbes.

 

Economic Study Finds VTE Prophylaxis with Low-Molecular-Weight Heparin Cost Effective Reply

Critically ill patients in the hospital are at high risk for developing venous thromboembolism (VTE). The 2011 PROTECT trial compared the two most common drug strategies used to prevent VTE — unfractionated heparin (UFH) and dalteparin, a low-molecular-weight heparin (LMWH) —  and found no difference between the two groups in the primary endpoint of the trial, leg deep-vein thrombosis.

But PROTECT did turn up a significant reduction in the dalteparin group in the important secondary endpoints of pulmonary embolism (PE) and heparin-induced thrombocytopenia (HIT). Now a prespecified economic analysis of PROTECT, published in JAMA, indicates that use of LMWH, though it is more expensive than UFH, may lead to lower hospital costs due to the reduction in PE and HIT.

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FDA Advisory Panel Gives Tepid Support To New Daiichi Sankyo Drug Reply

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban(Savaysa), but the outcome will likely result in a drug that will be on the market but that few physicians will prescribe until further studies are performed.

Click here to read the full post on Forbes.

Grad Student Invents Flying Ambulance Drone To Deliver Emergency Shocks Reply

Drones have been used to kill people in war zones and to spy on people. Now a sharp young  graduate student in the Netherlands has come up with an innovative new use for drones that could one day help save thousands of lives.

Click here to read the full post on Forbes.

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Ebola, Natural Cures, And Panic: A Rant Reply

I try to stick to writing about cardiovascular topics but it’s been hard to avoid thinking about ebola in recent weeks. Trying to take a break from the ebola insanity yesterday I turned to Facebook to find some cute cat videos. Instead, I found this, posted by an old friend, from the Organic Consumers Association:

There are natural methods proven to be effective for prevention and treatment of Ebola. But doctors refuse to explore them.

My friend simply asked her FB friends: “What do you think? Please share.”

I’m afraid I didn’t respond well:

Click here to read the full post on Forbes.

Organic Ebola FB

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Genetic Study Suggests Possible Causal Role for LDL in Aortic Valve Disease Reply

Although LDL is an important risk factor for aortic valve disease, the precise role it plays has been uncertain. Lipid-lowering therapy in people with established aortic valve disease has not been shown to be beneficial. Now, however, a new genetic study published in JAMA suggests that LDL cholesterol may in fact cause an increase in aortic valve calcium and aortic valve stenosis. This may mean that LDL-lowering therapy could prove beneficial when given earlier in the disease process.

Click here to read the full post on Forbes.

 

Paper Behind The Green Coffee Bean Diet Craze Retracted Reply

The “scientific” paper that helped ignite the green coffee bean diet craze has been retracted. The details of the retraction and the full background of the story were fully reported by Ivan Oransky on Retraction Watch.

The paper, published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, purported to report the substantial weight loss findings of a randomized, double-blind, placebo-controlled crossover study of green coffee bean extract. The article has been viewed or downloaded by more than three-quarters of a million people since its publication in January 2012.

Click here to read the full post on Forbes.

 

English: Photo of Dr.Oz at the Time 100 Gala.

English: Photo of Dr.Oz at the Time 100 Gala. (Photo credit: Wikipedia)

 

Cigna Sues Embattled HDL Laboratory For $84 Million Reply

The Cigna Health and Life Insurance company is suing Health Diagnostic Laboratory Inc. for $84 million.  As reported previously, the embattled lab company is the subject of an ongoing Federal investigation concerning kickbacks and fraudulent billing.

The charges against HDL in the suit filed last week in federal court closely echo the earlier allegations against the company.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack! Reply

Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals, including a patient and a health care provider, whose stories appear to confirm and provide additional perspective about the allegations in the earlier articles.

“Your test results are giving me a heart attack!”

Click here to read the full post on Forbes.

 

Another Diet Myth Exploded: Gradual Weight Loss No Better Than Rapid Weight Loss Reply

Once again, a popular weight loss myth has been exploded. It has been widely believed that weight loss, which is nearly always difficult to maintain, is even less likely to stay lost if it is the product of a rapid weight loss. The belief is even enshrined in current guidelines. Now a study published in The Lancet Diabetes & Endocrinology provides no support for this view. Instead, the study suggests that although long-term weight loss remains elusive regardless of the diet, short-term weight loss is actually more likely with rapid weight loss.

Click here to read the full post on Forbes.

 

Inappropriate Heart Stress Tests May Waste Half A Billion Dollars A Year Reply

Inappropriate cardiac stress tests may cost the US healthcare system as much as half a billion dollars each year, according to a new study published in Annals of Internal Medcine.

Click here to read the full post on Forbes.

 

Nuclear medicine myocardial perfusion scan wit...

Nuclear medicine myocardial perfusion scan with Thallium-201 for the rest images (bottom rows) and Tc-Sestamibi for the stress images (top rows). The nuclear medicine myocardial perfusion scan plays a pivotal role in the noninvasive evaluation of coronary artery disease. The study not only identifies patients with coronary artery disease, it also provides overall prognostic information or overall risk of adverse cardiac events for the patient. (Photo credit: Wikipedia)

 

Medicare Reimbursement for Lung Cancer Screening Provokes Debate 1

Although 160,000 people in the U.S. die each year from lung cancer, accounting for more than a quarter of all cancer deaths, screening for lung cancer remains controversial. Based on results from the National Lung Screening Trial (NLST) in 2011, the U.S. Preventive Services Task Force (USPSTF) issued a B recommendation in favor of low-dose CT screening for high-risk current and former smokers. Due to a provision in the Affordable Care Act, private insurance is now mandated. More recently, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) concluded that there is only low to intermediate confidence that “there is adequate evidence to determine if the benefits outweigh the harms.” The Centers for Medicare and Medicaid Services (CMS) is expected to issue a final decision on national coverage in 2015.

Click here to read the full post on Forbes.

 

First Drug-Coated Balloon Approved By FDA For Leg Blockages Reply

The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.

Click here to read the full post on Forbes.

 

FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device Reply

The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use.

Click here to read the full post on Forbes.