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.

 

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)

More Evidence Linking Sugared Drinks To Diabetes 1

A new study uncovers some potentially important new details about the association between sugared drinks and diabetes.

In a paper published in Diabetologia [pdf], researchers in the UK report on a study of more than 25,000 adults. Over the course of more than 10 years of followup 847 participants went on to develop diabetes. Instead of relying on a food frequency questionnaire, as in most earlier studies…

Click here to read the full post on Forbes.

 

(Photo by Spencer Platt/Getty Images)

No Benefit For A Commonly Used Cardiac Device Reply

Once again, after decades of common use, a frequently implanted device has been found to confer no benefit whatsoever over a much less invasive therapy. Cardiologists and radiologists often implant the device, called a retrievable inferior vena cava filter, inside people who are at high risk for developing potentially lethal blood clots. The filter is designed to prevent pulmonary embolism, an extremely dangerous condition that occurs when a blood clot from the legs migrates into the lungs. Now a new study published in JAMA shows that these devices provide no advantage over anticoagulant drugs which thin the blood.

Click here to read the full post on Forbes.

 

American Heart Association Cancels Baltimore Conference Reply

The American Heart Association announced last night the cancellation of a medical conference in Baltimore due to the unrest in the city. QCOR 2015, the Quality of Care and Outcomes Research Scientific Sessions, was scheduled to be held at the Hilton Baltimore from Wednesday to Friday this week.

Here is part of what the AHA said:

Click here to read the full post on Forbes.

 

 

Cardiovascular Outcomes With Merck’s Januvia: No Better Or Worse Than Conventional Care Reply

Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin).  The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo.”

Click here to read the full post on Forbes.

 

More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes Reply

More information about the highly anticipated new cholesterol lowering drugs from Amgen and Sanofi/Regeneron emerged today. A new new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that the drugs– Amgen’s evolocumab and Sanofi’s alirocumab– dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a mortality benefit. But, the authors and other outside experts warn, the outcome findings should be interpreted with caution until long-term, dedicated outcome studies are completed.

Click here to read the full post on Forbes.

 

Amgen Door Hanger

Inside The Scandal: Profit And Greed At An Embattled Laboratory Company Reply

How does a clinical laboratory company grow in a few short years from nothing to more than $400 million in revenue and over $100 million in profit? Since the same company just settled with the DOJ for as much as $100 million, it’s reasonable to suspect that growth was probably not entirely legitimate.

Now new information, gleaned from documents containing previously unreported details about the company, provides an inside look at the inner workings of the company and its rampant growth, fueled by greed and a massive disregard for law and industry standards. Except where otherwise indicated, the details of HDL’s finances reported below come from a financial statement and a spreadsheet prepared by the company and made available to me by a source. The details are consistent with information revealed by a former company employee with intimate knowledge of HDL’s finances.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Tonya Mallory, Former CEO and Co-Founder of Health Diagnostic Laboratory, Inc. in Richmond, Va. (PRNewsFoto/Health Diagnostic Laboratory, Inc.)

Medicines Company Drug Finally Gets Nod From FDA Advisory Panel Reply

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization.

Click here to read the full post on Forbes.

 

FDA Approves Amgen Heart Failure Drug Reply

The FDA on Wednesday approved ivabradine (Corlanor), Amgen’s new heart failure drug. The drug has been available for several years in Europe, where it is sold by Servier under the brand names of Corlentor and Procoralan.

Ivabradine was approved for the reduction of hospitalization from worsening heart failure.

Click here to read the full post on Forbes.

Corlanor logo

 

 

Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee Reply

Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical  trials with the drugs be added to the drugs’ labels.

The two trials were the first large large cardiovascular outcomes trials of any diabetes drugs. SAVOR-TIMI 53 studied saxagliptin (Onglyza, AstraZeneca) and EXAMINE studied alogliptin (Nesina, Takeda Pharmaceuticals).

Click here to read the full post on Forbes.

 

Heart Attack Risk Jumps After Divorce Reply

A new study shows that after a divorce people have an increased lifetime risk for heart attacks (myocardial infarction). Although previous studies have found that MIs occur more frequently in people who are divorced, this is the first study to prospectively examine the lifetime relationship between divorce and MI.

In a paper published in Circulation: Cardiovascular Quality and OutcomesDuke University researchers analyzed data from a nationally representative cohort of 16,000 adults who were followed from 1992 to 2010.

Click here to read the full post on Forbes.

 

Two Dirty Little Secrets About Electronic Health Records Reply

Here are two dirty little secrets about electronic health records (EHR). Just about everyone in the field already knows these secrets, and many are quietly horrified, but few want to discuss them since there are no obvious or easy solutions.EHRs Are a Threat to Freedom of Speech and Academic Freedom

Electronic Health Records Are Not Even Electronic Health Records

Click here to read the full post on Forbes.

 

DOJ Settles With Embattled Lab, Criminal Charges For Executives Still Possible Reply

In line with reports last monthHealth Diagnostic Laboratory Inc, the embattled lab company, has reached a settlement with the Department of Justice following a lengthy investigation into the company’s business practices, which include giving kickbacks to physicians and additional illegal sales, marketing, and billing practices.

HDL will initially pay at least $47 million to the government.

Note to readers: I have received a document from an inside source that provides a detailed snapshot of HDL’s past financial status. I plan to report this information next week.

Click here to read the full report on Forbes.

 

 

Previous Stories About HDL:

Weight Loss Programs: Slim Evidence And Poor Results Reply

A new study concludes that some weight loss programs may be slightly better than other programs but that in the long run none of the programs have been able to show a substantial weight loss over a sustained period. For even the best programs, an editorialist writes, “weight loss is modest and likely below patients’ expectations.”

In a paper published in Annals of Internal Medicine, researchers report on an updated systematic review of studies evaluating weight loss programs…

Click here to read the full post on Forbes.

 

No, You Probably Won’t Drop Dead While Exercising Reply

Dropping dead while exercising is a common fear, especially among middle-aged men. Unfortunately there have been limited data on the precise rate of sudden cardiac arrest (SCA) in middle-aged people and little understanding about the medical history of the victims of SCA. Now a new study fills in some important gaps in knowledge and shows that this fear is largely misplaced, given the small risk that exercise will lead to sudden cardiac death in most middle-aged people.

Click here to read the full post on Forbes.

 

During exercise there is a spike in cardiovascular risk, but over the long term exercise dramatically reduces overall risk. There is considerable debate whether the benefits of exercise continue to grow, flatten out, or are partially (or even largely) lost with extremely intense or prolonged exercise. (Original illustration by Max Husten)

During exercise there is a spike in cardiovascular risk, but over the long term exercise dramatically reduces overall risk. There is considerable debate whether the benefits of exercise continue to grow, flatten out, or are partially (or even largely) lost with extremely intense or prolonged exercise. (Original illustration by Max Husten)

 

Mark Cuban Should Take The Cigar Out Of His Mouth And Stop Giving Health Advice Reply

Last night the celebrity billionaire Mark Cuban ignited a firestorm on Twitter with the following recommendation to his 2.7 million followers:

1)If you can afford to have your blood tested for everything available, do it quarterly so you have a baseline of your own personal health

Led by ProPublica health reporter Charles Ornstein, a slew of doctors, health care experts, patient advocates and journalists tried to show Cuban the error of his ways.

Click here to read the full post on Forbes.

 

Cuban (large)

 

 

Global Cardiovascular Deaths Continue To Rise Despite Gains In Prevention And Treatment 1

Improvements in the treatment and prevention of cardiovascular disease haven’t been able to prevent a worldwide rise in cardiovascular deaths in a growing and aging population, according to the authors of a paper published in the New England Journal of Medicine. Using mortality data from the Global Burden of Disease Study 2013 the authors set out to “disentangle” the effects on cardiovascular mortality of population growth, an aging population, and epidemiological changes (defined as changes in risk factors and the effect of efforts to prevent and treat CV disease).

From 1990 to 2013 the total number of deaths caused by cardiovascular disease increased by 40%, from more than 12 million to more than 17 million a year.

Click here to read the full post on Forbes.

 

Doctors Halt Squabbling And Agree How To Manage Hypertension In People With Blocked Arteries Reply

There’s been a lot of drama in the hypertension field over the past few years. Initially sparked by the decision of the National Institutes of Health to end its sponsorship of national guidelines, the subsequent appearance of multiple guidelines with divergent recommendations led to even more controversy and discussion. Now, however, the appearance of a new scientific statement may indicate that some of the drama is dissipating, at least in one important subset of the field.

The scientific statement from the American Heart Association, the American College of Cardiology, and the American Society of Hypertension covers the important area of the treatment of hypertension in patients with existing coronary artery disease.

Click here to read the full post on Forbes.