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.

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Aortic Valve Surgery for Nonagenarians Reply

As people continue to live longer physicians are increasingly confronted with very elderly patients who have serious conditions that might benefit from surgery but who are at high risk for surgical complications. In a paper published in the Annals of Thoracic Surgerydoctors at the Mayo Clinic reviewed their experience with 59 patients age 90 or older who had severe aortic stenosis and underwent surgical (SAVR) or transcatheter aortic valve replacement (TAVR).

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.

 

Novel Boston Scientific Device Headed For Another Rough FDA Panel Reply

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak through.

Click here to read the full post on Forbes.

 

Nissen Urges Prompt Revision Of Cardiovascular Guidelines Reply

Sparked by a new study that once again finds serious flaws in the cardiovascular risk calculator at the heart of the American College of Cardiology/American Heart Association cardiovascular guidelines, Steve Nissen states that “the ACC and AHA should promptly revise the guidelines to address the criticisms offered by independent authorities.” The CV risk calculator is a key component of the guidelines, since people are generally considered candidates for statins if they have a 10-year estimated risk of CV disease of 7.5% or higher according to the equations used by the calculator.

In a study published in JAMA Internal MedicineNancy Cook and Paul Ridker, analyzing data from the Women’s Health Study, offer fresh evidence that the cardiovascular risk calculator used in the ACC/AHA cholesterol guideline is flawed. They found that the predicted rate of cardiovascular disease using the guideline calculator was significantly higher than the actual observed rate in the trial. They considered and ruled out several “alternative explanations” for the discrepancy, including underascertainment of events and the increased use of statins and revascularization procedures in their population.

Click here to read the full post on Forbes.

 

Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future Reply

Cholesterol drugs, both new and old, are in the news again. There’s a lot going on now but the picture won’t really become clear until next month, when the results of a decade-old trial will finally be revealed. Briefly, here’s what’s happening:

  • Two new trials presented fresh evidence that PCSK9s, the much discussed new class of cholesterol drugs, have powerful LDL-lowering properties.
  • A new drug from Esperion, the phoenix of biotech companies, also showed promising results. The drug, ETC-1002, is a few years behind the PCSK9s in development but has some important theoretical advantages that may prove very important down the road.
  • At the annual meeting of the American Heart Association in November the results of the IMPROVE-IT trial will be presented. The results of this trial, as I have argued in the past, may have a broad if not decisive impact on the future of the PCSK9s and ETC-1002.

 …

Click here to read the full post on Forbes.

 

Study Suggests Vitamin D Can’t Prevent Diabetes Reply

A vitamin D pill can’t substitute for a healthy diet and sunshine, a new genetic study published in The Lancet Diabetes & Endocrinology suggestsIn recent years many people have been seduced by observational studies that found low levels of vitamin D in people who developed type 2 diabetes. The new study instead suggests that the association is not causal, and that raising vitamin D by itself will not be helpful.

Click here to read the full post on Forbes.