FDA Evaluating Safety Of Testosterone Reply

The FDA said today that it was evaluating the cardiovascular safety of testosterone products. The investigation is prompted by two recent published studies that found a significant increase in cardiovascular events in men who received testosterone therapy.

Click here to read the full post on Forbes.

Original illustration by Max Husten

 

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American College of Cardiology Announces Late-Breaking Clinical Trials Reply

The American College of Cardiology announced the lineup of late-breaking clinical trials for its upcoming annual meeting in Washington, DC. The opening session will include the most eagerly anticipated trials– the main results of Symplicity HTN-3 and the  comparison of Corevalve and surgery in high risk patients. Subsequent sessions will include several phase 3 trials of  PCSK9 inhibitors. Here is the complete list of trials:

Click here to read the full post on Forbes.

 

Johnson & Johnson Will Share Clinical Trial Data 1

In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers. The company said that the Yale University Open Data Access (YODA) Project will serve as an independent third party “to review requests from investigators and physicians seeking access to anonymized clinical trials data.”

The company said that this program “is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data.”

Click here to read the full post on Forbes.

 

Problems Persist Despite Gains In Oral Anticoagulant Use Reply

Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk of stroke. Many elderly patients are not receiving oral anticoagulants and overall too many patients are still taking aspirin, despite the fact that it is not recommended for this group of patients.

In a paper published in the American Journal of Medicine, Gregory YH Lip and colleagues analyzed data from more than 3,100 patients surveyed in the Euro Observational Research Programme on Atrial Fibrillation from February 2012 to March 2013.

Click here to read the entire post on Forbes.

 

European Setback For Novartis Heart Failure Drug Reply

European regulators have dealt a setback to a novel heart failure drug under development by Novartis.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which was published in the Lancet in 2012. Here is CHMP’s explanation for their decision:

Click here to read the full post on Forbes.

 

 

 

Stent Remains Available Despite Trial Showing Dangers 1

A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes.

Now, in a paper published in BMJ, a group of physicians led by Rita Redberg say that by not removing Wingspan from the market the FDA is shirking its “responsibility to protect the public’s health.”

Click here to read the full post on Forbes.

Surviving A Heart Attack: Location And Time Make A Big Difference Reply

Two studies published this week offer fresh evidence that your life may depend on where and when you have a heart attack.

1. Heart attack patients in the United Kingdom are more likely to die than heart attack patients in Sweden, according to a study published in the Lancet.

2. Heart attack patients are more likely to die if they reach the hospital at night or on the weekends, according to a study published in the BMJ.

… 

Click here to read the full post on Forbes.

 

Dangerous Rapid Calcification Observed In Pediatric Patients After Aortic Valve Replacement Reply

Pediatric cardiac surgeons at Boston Children’s Hospital are warning the medical community about a potentially fatal problem in children and young adults who received a bioprosthetic valve manufactured by Sorin. The surgeons initially became concerned when a young asymptomatic patient died suddenly after her valve underwent rapid calcification, only 7 months after a routine followup echocardiogram found no signs of blockage.

Click here to read the entire post on Forbes.

 

FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve Reply

The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting.

Click here to read the full post on Forbes.

CoreValve Family Sizing

FDA Panel Once Again Rejects New Indication For Rivaroxaban Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members.

Click here to read the full post on Forbes.

 

English: Logo of the band Rejected Español: Lo...
(Photo credit: Wikipedia)

 

FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival.

Click here to read the entire post on Forbes.

 

English: The Kraken roller coaster ride at Sea...

(Photo credit: Wikipedia) 

 

 

 

Medicine Or Mass Murder? Guideline Based on Discredited Research May Have Caused 800,000 Deaths In Europe Over The Last 5 Years 2

Last summer British researchers provoked concern when they published a paper raising the possibility that by following an established guideline UK doctors may have caused as many as 10,000 deaths each year. Now they have gone a step further and published an estimate that the same guideline may have led to the deaths of as many as 800,00 people in Europe over the last five years. The finding, they write, “is so large that the only context in the last 50 years comes from the largest scale professional failures in the political sphere.” The 800,000 deaths are comparable in size to the worst cases of genocide and mass murder in recent history.

In their new article published in the European Heart Journal, Graham Cole and Darrel Francis continue to explore the extent and implications of the damage caused by the Don Poldermans research misconduct case….

Click here to read the full post on Forbes.

Hannibal Lecter

Hannibal Lecter (Photo credit: Wikipedia)

Rivaroxaban Faces Uphill Battle At FDA Advisory Panel Reply

The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Drugs Advisory Committee will take up the sNDA yet again, but FDA review documents posted today suggest that the company will again face an uphill battle.

Click here to read the full post on Forbes.

 

Stone wall of an English barn

 

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.”

 

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