Mobile Cardiovascular Screening Programs Come Under Fire Reply

It seems like a no brainer. Cardiovascular disease is the #1 killer in the world so broad screening of the general population must be a good idea, right? Wrong, says the consumer group Public Citizen, at least when such screening is performed indiscriminately. Somewhat surprisingly, Public Citizen, which is often held at arm’s length by mainstream medicine, gained some support for its position from a major cardiology organization.

In its statement Public Citizen urged 20 hospitals to sever their involvement in a mobile cardiovascular screening program. The HealthFair Cardiovascular Screening Packages are unethical, mislead consumers, and do more harm than good, said Public Citizen.

In a blog post, the president of the American College of Cardiology. Patrick O’Gara, said that “the questions raised about screening have some merit…. we do not recommend broad and untargeted screening.”

Click here to read the full post on Forbes, including a detailed comment from cardiologist Ethan Weiss.

 

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Mixed Results for Thrombolysis in Pulmonary Embolism Reply

The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation.

A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients. Overall, there was a significant, 47% reduction in mortality with thrombolysis relative to standard anticoagulation, but this was accompanied by significant increases in major bleeding, including intracranial hemorrhage.

Click here to read the full post on Forbes.

 

What Role Should Coca-Cola Play In Obesity Research? 1

What role should Coca-Cola and other food and beverage companies play in funding and communicating research about nutrition and obesity?

The question is prompted by a recent article in the Journal of the American College of Cardiology. The “state-of-the-art” paper reviews the relationship of obesity and cardiovascular disease and presents the case that a decline in physical activity is the primary cause of the obesity epidemic.  The article downplays the role of calories and diet and does not include the words “sugar,” “soda,” or “beverage.” Three of the five authors of the paper report financial relationships with Coca Cola.

Click here to read the full post on Forbes.

 

Original illustration by Max Husten

Original illustration by Max Husten

 

Cardiology And The Medicare Data Avalanche Reply

The avalanche of data released by Medicare on Wednesday was followed shortly by an avalanche of news reports about the data. Here’s a review of some of the more significant cardiology-related details that came out in these stories.

Cardiology was the third in New York Times list of total Medicare payments received by the highest-paid 2% of doctors. This 2% accounted for nearly one-fourth of total Medicare payments. There were 2,176 cardiologists in the top 2% group and they received more than 1.6 billion dollars from Medicare. Ahead of cardiologists at the top of the list were ophthalmologists (2,995 providers who received more than $3.3 billion) and hematologists/oncologists (1,831 providers who received more than $2 billion).

The Washington Post‘s Wonkblog asked the top 10 Medicare billers to explain their charges…

Click here to read the full post on Forbes.

 

Early Success For Novel Novartis Heart Failure Drug Reply

A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and heart failure hospitalization.

PARADIGM-HF randomized patients with heart failure and reduced left ventricular ejection fraction to either the ACE inhibitor enalapril or LCZ696, an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that is the first in its class.

Click here to read the full post on Forbes.

 

 

Steve Jobs Rejected The First Medical App In 1977 Reply

There’s been a lot of speculation that future Apple products will include health-related apps and biometric sensors. Here’s the story of what might have been the first Apple medical app, except for the fact that in 1977 Steve Jobs had absolutely no interest in going in that direction.

George Diamond is now retired after a long and very distinguished career as a cardiologist at Cedars-Sinai Medical Center in Los Angeles. But in 1977 he was just starting his career at Cedars, where he was working on cutting-edge devices and statistical methods to improve the diagnosis of heart disease (a major problem that even today is far from being solved).

So I picked up the telephone and called Apple in Cupertino. I told the secretary that I wanted to speak with somebody about a medical application for the Apple II computer. The secretary connected me directly to Steve Jobs. (Of course I didn’t know who he was. I didn’t even recognize the name as being one of the people who had actually invented the thing.)

Click here to read the full post on Forbes.

George Diamond today

Vitamin Supplements Come Up Short Once Again 1

Once again the U.S. Preventive Services Task Force (USPSTF) has concluded that there is no good evidence to support the routine use of multivitamins or most individual or combination vitamins by healthy adults to prevent cardiovascular disease or cancer.

The USPSTF also recommended against the use of two specific vitamins — beta-carotene and vitamin E. Beta-carotene has been linked to a significant increase in the risk for lung cancer among smokers, while “a large and consistent body of evidence has demonstrated that vitamin E supplementation has no effect on cardiovascular disease, cancer, or all-cause mortality.”

For other vitamins or multivitamins, the task force found few significant harms, though they said the evidence was insufficient to allow definitive assessments of the risks and benefits.

Click here to read the full post on Forbes.

Victor Dzau Leaving Duke To Head The Institute Of Medicine Reply

Cardiologist Victor Dzau will leave his positions as the chancellor for health affairs at Duke University and the CEO of the Duke University Health System to become the next president of the Institute of Medicine. He will replace Harvey Fineberg, who has been the IOM president for the last 12 years.

“I am humbled and honored to be selected to lead the IOM at a time of unprecedented opportunities and challenges in health, health care, and biomedical sciences,” said Dzau in a statement from the IOM. “Harvey Fineberg has been an exceptional leader of the IOM, and I am committed to building on his outstanding work and advancing the impact of the IOM on the nation and globally.”

Before moving to Duke almost a decade ago Dzau was the chair of the department of medicine and director of research at Brigham and Women’s Hospital and the Hersey Professor of the Theory and Practice of Physic (Medicine) at Harvard Medical School. Prior to that he had been the chair of the department of medicine at Stanford University. In his career as a researcher Dzau played a key role in understanding the renin-angiotensin-aldosterone system.

Robert Califf, director of the Duke Translational Medicine Institute, sent the following comment:

This appointment is a real honor for Victor and for Duke. During his tenure, the instituiton has grown into an academic health and science system, made numerous scientific contributions and thrived financially.

Dzau was first elected to the IOM in 1998. He will begin his six-year term as president on July 1.

 

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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Go Nuts! Consumption of Nuts Linked to Mortality Benefit Reply

Nut consumption has long been linked to healthy lifestyles. Now, a study in the New England Journal of Medicine extends the finding and demonstrates a strong association with improved mortality.

Ying Bao and colleagues examined data from nearly 120,000 people enrolled in the Nurses’ Health Study and the Health Professionals Follow-up Study to assess the relationship of nut consumption and mortality. With over 3 million person-years of follow-up, the investigators found a strong inverse correlation between the frequency of nut consumption and mortality, after adjusting for other risk factors.

Here are the hazards ratio for death based on frequency of nut consumption (compared to no consumption):

Click here to read the full story on Forbes.

English: a walnut and a walnut core

 

Replacement Versus Repair for Mitral Valve Regurgitation Reply

Surgery is thought to be life-saving for people who have ischemic mitral regurgitation, but it is unknown whether surgical repair or surgical replacement of the mitral valve is the better procedure. Repair is thought to result in fewer preoperative deaths and replacement is thought to have better long-term outcomes with a reduced incidence of recurrent mitral regurgitation. In recent years, many surgeons have grown to favor repair. Currently about two-thirds of patients in the US undergo a repair operation.

In a trial presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicinemembers of the Cardiothoracic Surgical Trials Network randomized 251 patients with severe ischemic mitral regurgitation to either repair or replacement.

At one year there was no difference in the primary end point, left ventricular end-systolic volume index, between the two groups. 

Click here to read the full post on Forbes.

 

Hypertension Treatment Flowchart Fills in for Missing Guideline Reply

When the AHA and the ACC released four updated clinical guidelines earlier this week, a fifth document, the hypertension guideline, was conspicuous by its absence. According to the AHA and the ACC, the authors of the hypertension document have chosen to publish it independently. (No word has yet emerged about their reasons for doing so or when the document will be published.) In response, the AHA and the ACC announced that they would publish full hypertension guidelines in 2014, but in the meantime would publish a brief interim document. Now the two organizations, in conjunction with the Centers for Disease Control, have published a scientific advisory on the AHA and the ACC websites.

Click here to read the full story on Forbes.

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The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT Reply

Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi), Amgen, and Pfizer might suffer significant delays.

The guidelines delivered a strong statement questioning the increasingly controversial theory that LDL lowering by itself is beneficial. “We found that non-statin therapies really didn’t provide an acceptable risk reduction benefit compared to their potential for adverse effects in the routine prevention of heart attack and stroke,” said the co-chair of the guideline. This led many observers to think that the FDA would likely require the developers of PCSK9 inhibitors to complete cardiovascular outcome trials before getting US approval. This decision would delay approval for several years.

Then, on Thursday, the companies developing PCSK9 inhibitors received some apparent good news. Bloomberg News reported that an FDA official said that the drugs “will only have to meet the U.S. Food and Drug Administration’s existing standards for clearance, including whether they cut cholesterol and reduce blood pressure or inflammation.”

But then the FDA added one other very important caveat. Here’s how they phrased it to me:

Click here to read the full post on Forbes.

 

FDA Seeks To Eliminate Trans Fats From Food In The US Reply

 

 

The FDA said today that it would begin to take efforts to remove trans fats from food in the USA. The agency has made the “preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not ‘generally recognized as safe’ for use in food.”

 

If the FDA’s preliminary determination is made final then manufacturers will be required to reformulate products containing PHOs. FDA will seek comments on the proposal for 60 days “to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat.”

Click here to read the full story on Forbes.

 

 

 

Healthy Diet In Middle Age Leads To Healthier Old Age Reply

New results from a long-running study offer fresh evidence that a “healthy” diet is actually good for you. The study shows that women who followed a healthy diet while in middle age had a much better chance of reaching 70 without any of the major illnesses or impairments usually associated with old age.

In a paper published in the Annals of Internal Medicine, Cecilia Samieri and colleagues analyzed data from 10,670 women who participated in the Nurses’ Health Study and who had no major diseases in the mid-1980s when they were in their late 60s and early 70s. They found that women with healthy diets (as assessed by the Alternative Healthy Eating Index-2010 and the Alternate Mediterranean diet scores) were much more likely to reach the age of 70 with no major chronic diseases, no impairment in cognition, no physical disabilities, and intact mental health.

Click here to read the full story on Forbes.

 

 

 

Invest In Pharma? Maybe Go To Vegas Instead. Reply

Instead of investing in pharma maybe you should go to Vegas instead. You’ll have a lot more fun and, a new study suggests, your chances of winning are just as good.

The key to understanding the pharmaceutical industry is predicting sales of individual drugs. But, in a study published in Nature Reviews, 3 consultants at McKinsey & Company determined that drug companies, and the sell-side analysts that watch them, have a really poor record when it comes to predicting future sales of drugs, not just unapproved drugs not yet on the market but also even approved drugs with existing sales.

Myoung Cha, Bassel Rifai, and Pasha Sarraf first assessed the accuracy of 1700 analyst’s estimates for 260 drugs launched between 2002 and 2011. Their findings were striking:

Click here to read the full post on Forbes.

A Paper In The American Journal Of Cardiology About A Study That Was ‘Not Real’ Reply

New allegations about scientific misconduct have been raised about a cardiology group in a hospital in Italy. Some of the allegations come from a surprising source: Maria Grazia Modena, the former and highly prominent chief of cardiology at the hospital where the research was said to have been performed.

The new allegations are the latest episode in an ongoing saga that began last year involving many of the same researchers, including Maria Grazia Modena herself. As I first reported last November, nine Italian cardiologists were arrested as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The charges included conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. The most prominent person arrested was Maria Grazia Modena, who is also a former president of the Italian Society of Cardiology. (The fact that she shares her last name with the city and the hospital where she works appears to be a coincidence.)

The suspicion that there might be problems with the paper  first emerged when Maria Grazia Modena, who was originally listed as a co-author, publicly distanced herself from the paper and said that she was not an author of the paper and had had nothing to do with the study. To date the only public acknowledgement that there might be problems with the paper is an erratum published in AJC stating that Modena “was not associated with this manuscript” and that “the authors apologize for this error.”

I personally asked the physicians and fellows who were working in the department (except the authors of the manuscript) if anyone have ever heard about the study. Nobody had ever seen informed consents or appointments for study-related peripheral echo in 8 years.

 In the methods section of their manuscript, the authors stated that echo examinations  were made with [a GE Healthcare transducer]… That echocardiography machine was bought around 2005-2006 (the authors  report they started the study  in 2002).

Click here to read the full post on Forbes.

 

Could Terrorists Have Hacked Dick Cheney’s ICD? 3

It happened in Homeland. Could it happen in real life?

In a 60 Minutes segment scheduled for broadcast tomorrow, Dick Cheney says that his doctors turned off the wireless function of his implanted cardiac defibrillator (ICD) “in case a terrorist tried to send his heart a fatal shock,” according to the Associated Press.

Years later, Cheney watched an episode of the Showtime series “Homeland” in which such a scenario was part of the plot.

“I found it credible,” Cheney tells “60 Minutes” in a segment to be aired Sunday. “I know from the experience we had, and the necessity for adjusting my own device, that it was an accurate portrayal of what was possible.”

I asked three experienced electrophysiologists– the cardiologists who devote a good part of their professional life implanting ICDs– whether this was a realistic concern…

Click here to read the full story on Forbes.

 

Prevalence Of Cardiovascular Disease Likely To Increase Despite Gains In Treatment Reply

It is the best of times and the worst of times in the battle against cardiovascular disease. On the one hand, mortality rates from cardiovascular disease in the US have dropped by more than half in the last 30 years, likely due in large part to improvements in treatment for elevated blood pressure and cholesterol levels and big declines in smoking. On the other hand, it is uncertain whether these gains will continue, and many experts think that cardiovascular disease may well be on the rise once again, largely due to the aging of the population and to increases in obesity and diabetes.

In an article in Health Affairs, Ankur Pandya and colleagues (including cardiologist Thomas Gaziano of the Brigham and Women’s Hospital) forecast cardiovascular disease trends through the year 2030 using data from the National Health and Nutrition Examination Survey. They project that although the age-adjusted risk for cardiovascular disease is likely to continue to decline through 2030, because of an aging population and the increase in obesity the overall incidence of cardiovascular disease will increase.

Click here to read the full story on Forbes.

 

 

 

New Questions Raised About Italian Cardiologists Already Under Cloud Of Suspicion 1

(This story was updated on Friday, October 4 with a response from Dr. Modena.)

New questions are being raised about the integrity and reliability of research published by a prominent Italian cardiologist and her colleagues. Last November, as previous reported here, Maria Grazia Modena, a former president of the Italian Society of Cardiology, and 8 other Italian cardiologists were arrested as part of a broad investigation into serious medical misconduct at Modena Hospital. To date the Italian authorities have not issued any indictments, but at least one aspect of the investigation appears to involve unauthorized research and failing to obtain informed consent from patients in clinical trials.

The new questions center on the same issue of research misconduct and the possibility that informed consent was not obtained from patients. The  questions– which were brought to my attention by a reader– center on a number of significant inconsistencies and highly improbable statements and statistics in a report of a purported randomized controlled trial published in the journal Heart in 2010. The questions raised about the paper lead to the inevitable suspicion that the trial very likely was not randomized and that patient consent may  not have been properly obtained.

Click here to read the full story on Forbes.

Saying Sorry May Not Be Good Enough For Novartis Reply

Novartis has issued a formal apology over misconduct relating to valsartan (Diovan) research in Japan, but that apology does not appear likely to satisfy the Japanese Health, Labor and Welfare Ministry, which plans to fully investigate the company’s role in the scandal. If necessary, ministry officials are prepared to raid the company’s offices in Japan.

A Novartis official apologized to the Japanese public for the apparent manipulation of data. David Epstein, the head of the pharmaceutical division at Novartis, met with the Japanese health minister. “We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry,” Epstein was quoted by Reuters after the meeting. He said the company was “willing to work with” Japanese investigators and will “take additional actions and potential sanctions in order to bring the issue to a good conclusion.”

Click here to read the full post on Forbes.

Editor: “Close to 10% of the papers we receive show some sign of academic misconduct” Reply

Originally posted on Retraction Watch:

elsevierThe latest issue of Elsevier’s Editors’ Update is part one of a two-part series on publishing ethics. It contains a bevy of articles on various issues that will be be familiar to Retraction Watch readers, from bias to research misconduct. (Not surprisingly, given the sheer number of journals they publish, Elsevier shows up regularly on Retraction Watch.)

In one of the pieces, Applied Surface Science editor in chief Henrik Rudolph pulls no punches:

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Speedy Tour de France Racers Slower To Die Reply

In recent years concerns have been raised about possible adverse cardiovascular effects of intense endurance exercise. Additional concerns have been  raised about sports where performance enhancing drugs are commonly used. However, a new study shows that despite these potential hazards, elite endurance athletes appear to live longer than their contemporaries.

 Xavier Jouven, a triathlete and a researcher at the Sudden Death Expertise Center in Paris, France, gathered mortality information from all 786 French participants in the Tour de France from 1947 through 2012 and compared them to people of the same age in the French general population. The study was presented at the European Society of Cardiology in Amsterdam and published simultaneously in the European Heart Journal.

By 2012, 208 of the French cyclists had died. They had a 41% reduction in mortality compared to their cohorts in the general population (standardized mortality ratio 0.59, CI 0.51-0.68, p<0.0001).

Click here to read the full post on Forbes.

 

"Get a bicycle. You will not regret it, if you live." --Mark Twain

“Get a bicycle. You will not regret it, if you live.” –Mark Twain

 

Disappointing Results with Dabigatran for Mechanical Valves 1

Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been hoped that the newer generation of oral anticoagulants might eventually replace warfarin, making anticoagulation more tolerable and better accepted, since these agents don’t require continuous monitoring and have much fewer serious interactions with other drugs and food. So far, however, there has been no convincing demonstration that the the newer agents are as safe and effective as warfarin for this indication.

RE-ALIGN was a phase 2 dose-validation study of dabigatran in patients with mechanical heart valves. Results of the trial were presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of Medicine.  Patients in the trial were randomized to dabigatran or warfarin.

After 252 patients had been randomized, the trial was stopped early due to an increase in thromboembolic and bleeding events in the dabigatran group:

Click here to read the full post on Forbes.

Positive Results for New Anticoagulant From Daiichi Sankyo Reply

A new entrant in the growing oral anticoagulant field shows promise for the treatment of venous thromboembolism (VTE) and pulmonary embolism (PE). The drug, edoxaban, is a new, once-daily Factor Xa inhibitor with a rapid onset of action that is under development by Daiichi Sankyo. Results of the Hokusai-VTE trial were presented at the European Society of Cardiology meeting in Amsterdam and published simultaneously in the New England Journal of Medicine.

The Hokusai-VTE investigators randomized 4921 patients with VTE and 3319 patients with PE to either warfarin or edoxaban. The trial differed from some earlier trials with new oral anticoagulants in that patients were treated following a lead-in period with heparin. In addition, patients were treated for as short as three months or as long as a year at the discretion of the physician, though patients were followed for a full year. Patients with low body weight or renal impairment received a half dose of edoxaban. The investigators said the design was intended to reflect the full spectrum of conditions clinicians see in real life.

Click here to read the full story on Forbes.