Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel Reply

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain.

FDA approval of Entresto is expected to occur by August at the latest. There are no apparent roadblocks to approval since Novartis has stated that it doesn’t expect an FDA advisory panel. Approval might well come earlier this summer.

At the ESC heart failure meeting this weekend Entresto investigators will also deliver some supporting secondary information about the drug….

Click here to read the full post on Forbes.

 

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No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize 1

Let’s start with a quick poll:

 Which is worse?

  • A. The pervasive influence of industry on medicine, which has undermined the independence and altruism of physicians.
  • B. The critics of industry influence, who have created a paranoid culture of distrust which has undermined the partnership of industry and physicians that has brought medicine to its current heights.

If you chose B then you are going to really love Lisa Rosenbaum’s 3-part series in the New England Journal of Medicine in which she argues that the reaction against the influence of industry has proved to be far worse than any damages those conflicts of interest (COI) have actually produced.

I think Rosenbaum is almost completely mistaken in her views…

Click here to read the full post on Forbes.

 

 

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Get A Grip! Global Study Shows Grip Strength Is a Simple And Powerful Predictor Of Death Reply

A large global study finds that grip strength is a simple, powerful, and broadly applicable test that can help predict the risk of death and cardiovascular disease. The new findings from the Prospective Urban-Rural Epidemiology (PURE) study were based on data from nearly 140,000 adults in 17 countries. The study participants had their grip strength measured with a handgrip dynamometer and were followed for roughly 4 years.

The results, published in the Lancet, show that grip strength is an even stronger predictor of death than systolic blood pressure…

Click here to read the full post on Forbes.

 

Diet Drug Study Crashes And Burns In The Wake Of Leaked Results Reply

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early interim analysis of the study.

The news about the trial was announced in a press release from the companies and a press release from the Cleveland Clinic, the home institution of Steve Nissen, the trial’s chairman.

Click here to read the full post on Forbes.

 

Previous Coverage:

Steven Nissen (AP Photo/Judi Bottoni)

Prominent Harvard Cardiologist Moves To Google X To Head Large Study Reply

Here’s a clear sign of the ascending role of digital/precision/personalized medicine: a prominent cardiologist has left a top academic and clinical position in Boston to run a large, innovative study in Silicon Valley. Jessica Mega was widely perceived as a rising star at Harvard Medical School and the Brigham and Women’s Hospital. She has now joined Google X, Google’s research arm, where she will head up the much publicized Baseline Study.

“I’m jealous,” said one academic cardiologist at a top hospital, upon hearing the news.

Baseline is one of the ambitious projects undertaken by the life sciences division of Google X….

Click here to read the full post on Forbes.

 

Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech Reply

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use of the drug beyond its current highly restricted FDA-approved indication (see reports in Forbes, the New York Times, and the Wall Street Journal.)

Click here to read the full post on Forbes.

 

 

Precision Medicine Approaches Peak Hype Reply

No, Personalized Medicine Isn’t Going To Save $600 Billion Over 50 Years By Preventing Heart Disease

The hype over personalized medicine has now reached astonishing new heights.  In an article published in the Lancet, Victor Dzau, the new president of the Institute of Medicine, and coauthors write that personalized and precision medicine (PPM) could deliver hundreds of billions of dollars worth of improved health in the US over the next 50 years.

They used a health simulation model to estimate the effect of improved screening and risk prediction to treat people at high risk for 6 diseases: cancer, diabetes, heart disease, high blood pressure, lung disease, and stroke. They then calculated the resulting gains in life expectancy and quality-adjusted life expectancy.

They calculated that reducing heart disease by 50% “would generate a staggering $607 billion in improved health over 50 years.”

Click here to read the full post on Forbes.

 

Victor Dzau

Victor Dzau

 

 

 

 

 

 

 

 

200-Year-Old Heart Drug Linked To Increased Risk Of Death Reply

For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin.  Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there have been no randomized trials in AF and only one trial, the famous DIG trial, in HF. In that trial digoxin had no impact on mortality but was found to help reduce the rate of hospitalization for HF.

Now researchers led by Stefan Hohnloser have performed a meta-analysis, published in the European Heart Journal, of 19 studies of digoxin, including more than 235,000 AF patients and 91,000 HF patients.

Click here to read the full post on Forbes.

 

Digoxin is derived from the foxglove plant (Digitalis lanata). (Photo by Oli Scarff/Getty Images)