Packaging Defect Leads Merck To Recall All Lots of Liptruzet In US Reply

Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the US. The company said the recall was due to a packaging defect which could potentially allow air and moisture to affect the quality of the drug, though the company said “the likelihood of the packaging defects decreasing the effectiveness of Liptruzet on a patient’s lipid profile or negatively impacting the safety of the product is remote.” To date there have been no adverse events or product complaints reported to the company.

Merck is recalling the drug from US wholesalers but is not asking patients or pharmacies to return their stock. The company said that patients may continue taking the pills already in their possession.

Today action will deplete the current supply of the drug in the US, the company said. The company said it will resupply the drug “as soon as possible.”

 

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Minority Report: Five Guideline Authors Reject Change In Blood Pressure Goal Reply

It didn’t seem possible but the guideline situation just got even more confusing. Last December, after  years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, the target remained the same for adults under 60 years of age but for people over the age of 60 the new guideline set a more conservative, easier-to-achieve target of 150 mm Hg or lower.

Now, however,  five of the 17 JNC 8 authors have written a commentary, published in Annals of Internal Medicine, disagreeing with this change. They say they are in agreement with the other major recommendations of JNC 8 but that they reject the new target, arguing that the evidence does not support the change, and predict that the change may well lead to harmful consequences.

Click here to read the full post on Forbes.

Confusion

 

Merck’s Vorapaxar Gets Positive FDA Review Reply

A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with a new analysis of one of those trials, the TRA2P trial. Now the FDA appears willing to give the drug a renewed lease on life.

Click here to read the full story on Forbes.

 

Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug Reply

Aegerion Pharmaceuticals disclosed today that it is being investigated by the US Department of Justice over its marketing of Juxtapid (lomitapide). The drug was approved in December 2012 to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The drug costs $250,000 a year. The approval came with a box warning about the risk of hepatotoxicity and a strict Risk Evaluation and Mitigation Strategy (REMS) Program which requires certification of health care providers and pharmacies before the drug can be prescribed and dispensed.

Last November the company received a warning letter from the FDA after Aegerion’s CEO, Mark Beer, made comments on CNBC improperly promoting the drug.

Click here to read the full post on Forbes.

 

 

Pivotal Medtronic Trial For ‘Breakthrough’ Blood Pressure Device Goes Down The Tubes Reply

The hypertension community woke up this morning to a large dose of reality with an announcement by Medtronic that the novel SYMPLICITY HTN-3 trial of its much-anticipated  renal denervation device had failed to meet its primary efficacy endpoint. Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension.

“SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months,” said Deepak Bhatt, the co-principal investigator of the trial, in the Medtronic press release. “Importantly, however, the trial did not meet its primary efficacy endpoint.”

Click here to read the full post on Forbes.

 

Hospital Quality Helps Explain Some Of The Racial Disparities In Outcomes After CABG Reply

It has long been known that racial disparities exist in health care. A large body of research has found that nonwhite patients have worse outcomes than whites. But it has been difficult to understand the underlying reasons for these disparities.  Now a new study offers evidence that, at least in the case of bypass surgery, a significant but by no means complete portion of this disparity is due to decreased access among nonwhites to high quality hospitals.

In a paper published in JAMA Surgery, Govind Rangrass and colleagues analyzed Medicare data from 173,925 CABG patients. 8.6% of the study population was nonwhite. The mortality rate was 3.6% for the entire population. Nonwhite patients had a 34% increased risk of dying.

A key finding was that the third of hospitals that had the highest proportion of nonwhite patients (more than 17.7% nonwhite) also had the highest risk-adjusted mortality for both white and nonwhite patients (3.8% and 4.8%)….

Click here to read the full post on Forbes.

 

First Retraction In the Don Poldermans Case Reply

Retraction Watch reports the first formal retraction of a paper by Don Poldermans, the disgraced Dutch cardiovascular researcher.

  • Feringa HH, Elhendy A, Bax JJ, Boersma E, de Jonge R, Schouten O, Karagiannis SE, Schinkel AF, Lindemans J, Poldermans D. Coron Artery Dis. 2006 May;17(3):255-9. Baseline plasma N-terminal pro-B-type natriuretic peptide is associated with the extent of stress-induced myocardial ischemia during dobutamine stress echocardiography.

Here is the text of the retraction:

Feringa HH, Elhendy A, Bax JJ, Boersma E, de Jonge R, Schouten O, et al. Baseline plasma N-terminal pro-B-type natriuretic peptide is associated with the extent of stress-induced myocardial ischemia during dobutamine stress echocardiography. Coron Artery Dis 2006; 17:255–259.—A Committee established by the Board of Erasmus Medical Center, The Netherlands, that reported in September 2012, considers the reporting of the research by Feringa et al. to have been negligent and scientifically incorrect according to two criteria: the inclusion and exclusion criteria reported in the publication were not applied consistently, with the result that the patient population actually studied differs in material ways from the published description; and, there are material differences between the source documentation (the patients’ dossier), the case record form used in the study, the study database, and the publication. For this reason the article by Feringa et al. is retracted from publication.

In 2012 JACC issued a notice of concern about three papers co-authored by Poldermans, but those papers have not been retracted so far. I am not aware of any other retractions or similar notices of concern. However, the European Society of Cardiology has stated that it is performing an urgent review of the guidelines for perioperative beta-blockade following a report last summer that the guidelines– which relied heavily on discredited research by Poldermans– may be responsible for thousands of deaths each year.

Click here for my previous coverage of the Poldermans case.

 

FDA Advisory Panel To Review New Heart Failure Drug From Novartis Reply

A novel acute heart failure drug from Novartis will be evaluated next month by an FDA advisory committee, perhaps countering a long string of crash-and-burn cardiology drugs. On February 13 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection from Novartis. The indication is for the improvement of the symptoms of acute heart failure through reduction of the rate of worsening of heart failure. (The meeting notice has been posted in the Federal Register but has not yet appeared on the FDA website.) Last year the drug received a “breakthrough therapy” designation from the FDA.

Click here to read the full post on Forbes.

 

Mediterranean Diet Protects Against Diabetes, Regardless of Weight Loss Reply

Even if it doesn’t lead to weight loss, a Mediterranean diet could help prevent the onset of type 2 diabetes, according to a subanalysis of last year’s influential PREDIMED study. In the main trial, reported in the New England Journal of Medicine, nearly 7500 people at high risk for cardiovascular disease were randomized to a low-fat diet or a Mediterranean diet supplemented by either extra-virgin olive oil (EVOO) or nuts. After nearly 5 years’ follow-up, the study was stopped early because of a significant reduction in cardiovascular events in the Mediterranean diet groups.

The new paper, published in the Annals of Internal Medicineexamines the development of diabetes — a prespecified secondary outcome — among the 3541 participants who did not have diabetes at baseline and for whom the follow-up diabetes status was available. After 4.1 years’ follow-up, there was a significant 30% reduction in the risk for diabetes in the combined Mediterranean diet groups compared with the low-fat diet group (HR 0.70,  CI 0.54 – 0.92)….

Click here to read the full story on Forbes.

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Apple Patent Could Add Heart Sensor To iPhones 1

On Christmas Eve the US Patent Office dropped a present down Apple’s chimney: a patent for a “seamlessly embedded heart rate monitor” that might one day allow an iPhone to identify and authenticate a user through the unique signature of the heart’s electrocardiogram (ECG).

 

Click here to read the full story on Forbes.

 

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Massive Heart Attack Or Massive Journalistic Irresponsibility? 2

A great lesson in how not to report about heart attacks in the general media, from Gary Schwitzer, health journalism watchdog:

Journalists: don’t use the term “massive” heart attack if you don’t know what you’re talking about

 Very quickly, the term “massive heart attack” started going viral among Minnesota news organizations and on Twitter and Facebook.

Two and a half hours later, Rybak was tweeting from the hospital: “My cardiac surprise/Gave me quite a start/But it proves this politician/Has a great big heart.”

“His former spokesman, John Stiles, described the heart attack as “serious,’’ but said Rybak will be released in several days.”

“Massive heart attack” is a vague, frightening, dangerous term to be throwing around in the absence of evidence. I know how I reacted when I read the news yesterday; many other readers’ comments showed that they thought Rybak was dead or dying imminently.

Read the entire post at HealthNewsReview.Org.

 

Is cancer “by far, the harder problem”? Reply

Really? Does everyone seem to have cancer? Compared to heart disease is cancer “by far, the harder problem”?

Half a century ago, the story goes, a person was far more likely to die from heart disease. Now cancer is on the verge of overtaking it as the No. 1 cause of death.

Troubling as this sounds, the comparison is unfair. Cancer is, by far, the harder problem — a condition deeply ingrained in the nature of evolution and multicellular life.

–George Johnson: Why Everyone Seems to Have Cancer, The New York Times

FDA Plans New Safety Assessment Of Dabigatran (Pradaxa) Reply

Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin.

n December 30 the FDA posted a request for public comment on a proposed protocol of the study, which it describes as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.”

Click here to read the full post on Forbes.

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Two Views Of Death: The Scientist And The Novelist 1

Here are two completely different ways of looking at death. One is a completely objective, coldly beautiful perspective. The other is deeply personal and troubling. Both are worth reading.

Here’s the scientific view:

Your probability of dying during a given year doubles every 8 years. For me, a 25-year-old American, the probability of dying during the next year is a fairly minuscule 0.03% — about 1 in 3,000. When I’m 33 it will be about 1 in 1,500, when I’m 42 it will be about 1 in 750, and so on. By the time I reach age 100 (and I do plan on it) the probability of living to 101 will only be about 50%. This is seriously fast growth — my mortality rate is increasing exponentially with age.

This is from the blog Gravity and Levity written by a young physicist, Brian Skinner….

A very different view of death comes from the novelist Margaret Drabble. Writing in the Guardian, she writes about the implications of “artificially prolonged old age”:

As we move into our unwanted last decade, we will, entirely predictably, become lonelier and lonelier and more and more likely to suffer from dementia and more and more expensive to maintain.

Click here to read the full post on Forbes.

 

English: Skull and crossbones

 

Big Sugar Tips The Balance Of The Research Scale Reply

It might seem obvious: people who drink sugar-sweetened beverages are more likely to gain weight or to be obese. Most research supports this intuitive finding. The big exception: when researchers receive support from the sugar and beverage industries they are much less likely to make the connection.

Researchers in Germany and Spain conducted a systematic review of systematic reviews (yep) examining the association between sugar-sweetened beverages and weight gain and obesity.

Click here to read the full post on Forbes.

Sugar Sweetened Beverages

 

Cardiology in 2013: Like A Wrecking Ball 1

Perhaps I’m being overdramatic but I think  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball.

The Guidelines Wrecking Ball: Like Hannah Montana guidelines are supposed to be boring and reliable.  But in 2013 the guidelines were more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its long-entrenched and highly influential role in producing cholesterol and hypertension guidelines. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy didn’t go away. One easy prediction for 2014: we’ll see more debate about guidelines.

Click here to read the full post on Forbes.

Wrecking Ball

The New Guidelines

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The Old Guidelines

3 More Retractions For Emory Cardiology Group Reply

Three more articles from R. Wayne Alexander’s research group at Emory have been retracted in the last two months. Three papers were retracted in 2011, bringing the group’s current total to 6. (News about the recent retractions was first reported on Retraction Watch.)

Click here to read the full post on Forbes.

 

R Wayne Alexander
R Wayne Alexander

 

Studies Suggest You Can Help Your Heart By Walking More And Eating More Fiber 1

It probably won’t come as a surprise, but walking more and eating more fiber are probably good for your heart. That’s the conclusion of two new studies, but because the studies relied on observational data it should be emphasized that they are incapable of demonstrating cause and effect. And it’s by no means clear that most people are willing to undertake the effort needed to achieve effective lifestyle changes like these.

Walking

In the first study, published in the Lancet, researchers analyzed data from 9,300 people with impaired glucose tolerance (and therefore at high risk for developing diabetes) and with existing cardiovascular disease or at high risk for CV disease.

Eating

In the second paper, published  in BMJ, investigators performed a systematic review of studies examining the effect of dietary fiber on cardiovascular and coronary heart disease.

Click here to read the full post on Forbes.

 

Keep Moving 

 

Missing High Blood Pressure Guideline Turns Up In JAMA Reply

After  years of delay and many twists and turns, the hypertension guideline originally commissioned by the NIH has now finally been published in JAMA. The evidence-based document contains a major revision of hypertension treatment targets and includes new and somewhat simplified recommendations for drug treatment.

The previous US hypertension guideline was published more than a decade ago. After many delays the new guideline was ready for publication earlier this year, but then the NIH decided to get out of the guidelines business. The American Heart Association and the American College of Cardiology assumed responsibility for the development and publication of cardiovascular guidelines and last month published four new cardiovascular guidelines, with the notable exception of the hypertension guideline. As an accompanying JAMA editorial explains:  “Rather than go through an additional review process with the AHA and the ACC the authors decided to publish their guideline in JAMA on their own.”

The big headline of the new guideline is an important change in treatment targets.

Click here to read the full story on Forbes.

Original illustration by Max Husten

Original illustration by Max Husten

New Trial Confirms Role For Pradaxa In Venous Thromboembolism Reply

A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for the treatment of  deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is currently approved only for the treatment of stroke prevention in patients with non-valvular atrial fibrillation.

In RE-COVER II 2,589 patients with acute VTE were  randomized to dabigatran or warfarin following standard heparin treatment for 5 to 11 days. At 6 months the rate of recurrent VTE and related deaths was 2.3% in the dabigatran group versus 2.2% in the warfarin group (HR 1.08, CI 0.64 – 1.80; p<0.001 for noninferiority). There were no significant differences in the incidence of deaths, adverse events, and acute coronary syndromes.

Click here to read the full post on Forbes.

 

Pradaxa

Behind The Curtain: Study Reveals Big Role of Medical Communication Companies Reply

Everyone knows that medical information flows out of medical centers and schools, research institutions and the NIH, pharmaceutical companies, journals and medical societies. But one important information source — medical communication companies (MCCs)– “are among the most significant but least analyzed health care stakeholders,” according to Sheila Rothman and colleagues. In a new report in JAMA they set out to explore the important but poorly understood role of MCCs.

Until recently little has been known about these companies. But in recent years, either as a result of legal settlements with the government or public pressure, 14 pharmaceutical and device companies have published their grant awards on the internet. In 2010, the authors report, the 14 companies gave $170 million to MCCs, “more funds than any other recipient, including academic medical centers, professional associations, and research organizations.” Almost all the MCCs were for-profit companies. The top recipient of industry funds was Medscape/WebMD, which received more than $20,000,000, representing 12% of all awards to the MCCs.

Click here to read the full post on Forbes.

Blank "Caution" sign

 

Case Closed: Multivitamins Should Not Be Used 1

The editorialists are fed up: “Enough is enough.” Writing about three new papers in the Annals of Internal Medicine that find no benefits for the use of multivitamins — only the latest in a long line of negative findings — Eliseo Guallar and colleagues write:

…we believe that the case is closed— supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough.

In the first paper,  Stephen Fortmann and colleagues performed an updated systematic evidence review of vitamin and mineral supplements for the US Preventive Services Task Force (USPSTF).

In the second paper, investigators from the Physicians Health Study II randomized nearly 6,000 physicians 65 years of age or older to  a multivitamin or a placebo.

In the third paper, Gervasio Lamas and his fellow investigators in the NIH’s Trial to Assess Chelation Therapy (TACT) randomized 1,708 patients who had had a heart attack to a multivitamin supplement or placebo.

Click here to read the full story on Forbes.

 

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Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J Reply

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee suggests that the companies have made progress resolving earlier problems.

Merck’s new drug application for vorapaxar (Zontivity is the proposed trade name) will be discussed on January 15 for the proposed indication of reduction of atherothrombotic events in patients with a history of myocardial infarction (MI).

On January 16 the panel will discuss the supplemental new drug application for J&J’s Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients in the first 90 days after suffering acute coronary syndrome.

Click here to read the full story on Forbes.

English: Logo of the .

Dispatch From The Wild Frontier Of The Statin Wars Reply

The long simmering controversy over the relative benefits and harms of statins has heated to a high boil with the release of the new AHA/ACC US guidelines. But nowhere is the battle more intense right now than in Australia where, according to the National Heart Foundation, a TV show may be the cause of 2,000 heart attacks and strokes over the next five years.

The show was a 2-part documentary  (click here for part 1 and part 2) broadcast in October on the Australian ABC network about dietary fat and cholesterol.

The program, wrote Amy Corderoy, the health editor of the Sydney Morning Herald, “claimed the causal link between saturated fat, cholesterol and heart disease was ‘the biggest myth in medical history’… [and described statins] as toxic and potentially deadly.”

Catalyst delved into a raging debate: has dietary guidance telling us to avoid fats pushed us towards more harmful sugar and carbohydrates instead?

But the program also went a step further, arguing cholesterol was just an innocent bystander in the body’s attempts to deal with the sugar-damage. It was not a big leap to claim statins were dangerous, and the research supporting them fraudulent.

Click here to read the full post on Forbes.

 

Heart of the Matter screen shot

 

 

FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific Reply

The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the vote was 13-1.

Click here to read the full story on Forbes.

 

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