Califf To Leave Duke To Become FDA Deputy Commissioner Reply

The FDA announced today that Duke University cardiologist Robert Califf will be the next FDA Deputy Commissioner for Medical Products and Tobacco. The agency said that Califf will be responsible for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.”

Click here to read the full post on Forbes.

 

Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race Reply

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.

Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics License Application (BLA) for alirocumab, their PCSK9 inhibitor…

Click here to read the full post on Forbes.

 

Salt, Science, And The American Heart Association’s Double Standard Reply

Once again the American Heart Association is sticking by its recommendation that pretty much everyone should consume no more than 1,500 milligrams of sodium each day. This is dramatically lower than the 3,500 mg/d the average American now consumes. In a blog post reprinted on MedPage Today the president of the American Heart Association,  Elliott Antman, assails a study published earlier this week which found no benefits– and even a hint of harm–  for elderly people with low sodium consumption.

But Antman only tells one side of the story.

Click here to read the full post on Forbes.

 

New Device to Lower Resistant High Blood Pressure Shows Early Promise 1

A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from privatelyheld ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates a connection between the vein and the artery, which lowers blood pressure in the arteries by letting some of the blood drain off into the veins.

In a paper published in the Lancet, European investigators report the results of an open-label trial in in which 83 patients with persistent high blood pressure despite taking multiple antihypertensive drugs were randomized to implantation of the Coupler device or current treatment…

Click here to read the full post on Forbes, including comments from Franz Messerli, Sripal Bangalore, and Deepak Bhatt.

 

Why Doctors, Like Airline Pilots, Should Not Be Completely Trusted.  Reply

I would never get on an airplane if I didn’t feel highly confident that the pilot was fully competent. In order to fly a commercial airplane a pilot has to  undergo rigorous and continuous training and testing. I’d walk before flying with a pilot whose only credential was his assurance that he’d been diligently “keeping up with his field” and that he was extremely confident in his abilities. I’m glad to know that the FAA and the airlines have extremely demanding programs to ensure the competency of pilots.

I would trust 99% of pilots to remain competent on their own. But when it comes to flying 99%” isn’t good enough. We need to know, within the bounds of what is reasonable, that all pilots are competent. Unfortunately, because of the few bad ones, the remaining 99% have to undergo all the rigorous training and tests.

Doctors are like pilots: what they do is far too important to let them individually decide for themselves whether they are competent, or how they should demonstrate their competency. Just because the vast majority of pilots and doctors are competent doesn’t mean that we should loosen our standards.

This topic is important now because of a current red-hot debate over what physicians have to do during their career to maintain their certification– called maintenance of certification, or MOC…

Click here to read the full post on Forbes.

 

Intense Exercise Doesn’t Eliminate the Hazard of Intense Sitting Reply

James Brown had it right. There may be no better medical advice these days than to “Get Up Offa That Thing.

A large new analysis published in Annals of Internal Medicine supports earlier observations that the health hazards of sedentary behavior aren’t completely neutralized by exercise.

Researchers in Toronto scoured the literature to find studies that assessed the health effects of sedentary behavior adjusted for physical activity. They found 47 studies, including 13 that assessed all-cause mortality, 14 that assessed cardiovascular disease and diabetes, and 14 that assessed cancer. Sedentary behavior was defined as “waking behaviors characterized by little physical movement and low-energy expenditure,” including sitting and television watching.

Click here to read the full post on Forbes.

 

James Brown screenshot

 

How Much Salt Should Old People Consume? Reply

A new study offers fresh evidence that current salt recommendations should be taken with, well, a grain of salt. Current guidelines now recommend that everyone should have sodium intake levels below 2300 mg per day. For many people at higher risk, including everyone over 50 years of age, sodium intake should be below 1500 mg/d. (The American Heart Association promotes the more rigorous goal of 1500 mg/d for everyone.) But a 2013 report from the Institute of Medicine, along with findings from the PURE study published last year, have raised concerns that the lower target level in particular is neither practical nor beneficial.

The new study, published in JAMA Internal Medicine, looks at the growing and important elderly patient population…

Click here to read the full post on Forbes.

 

 

Buried Clinical Trial Data: The Dam Is About to Burst Reply

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials.

… a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the same time the trial is registered. The report includes detailed recommendations for when and how the data should be made available. Among the major recommendations: data underlying a trial analysis should be made available within 6 months after journal publication, and all data should be made available no later than 18 months after the last patient visit in the trial.

… the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson is expanding its plans to share data.

Click here to read the full post on Forbes.

 

AstraZeneca Drug Improves Outcomes After Heart Attacks Reply

For the first time a very large trial has shown that dual antiplatelet therapy (DAPT) improves cardiovascular outcomes when given to patients one to three years after a heart attack. Because it has been shown previously to reduce the high risk of recurrent events for up to a year following a heart attack, DAPT is considered to be standard therapy during this time period. But whether or not longer term treatment after a year would be also beneficial has been controversial.

AstraZeneca  today announced that the Pegasus-TIMI 54 study had successfully reached its primary endpoint.

Click here to read the full post on Forbes.

 

Success For 40-Year Effort In One Rural County To Curb Cardiovascular Disease Reply

A 40-year program in one poor rural county to combat cardiovascular disease appears to have been successful, resulting in reduced rates of hospitalization and death compared with other counties in the same state over the same time period. The new findings from the study are described in a paper published in the Journal of the American Medical Association.

Click here to read the full post on Forbes.

 

Millions Of Americans Taking Aspirin When They Shouldn’t Reply

More than a third of US adults– more than 50 million people– now take aspirin for the primary and secondary prevention of cardiovascular disease. (Primary prevention is the prevention of a first event; secondary prevention is the prevention of a recurrent event.) Although it was once broadly recommended, because of the increased risk of bleeding complications the use of aspirin for primary prevention of cardiovascular disease is now only indicated in people who have a moderate to high 10-year risk. (Aspirin is still broadly recommended for secondary prevention.) Now a new report  published in the Journal of the American College of Cardiology finds that there are still a significant number of people who are receiving aspirin inappropriately.

Click here to read the full post on Forbes.

 

More Turmoil For Troubled Medical Laboratory Company Reply

Problems continue to accumulate for the deeply troubled medical laboratory company Health Diagnostic Laboratory. Following several years of spectacular growth, in which the company grew to $400 million in annual revenue, the company last year began an equally spectacular implosion when it became known that the federal government was investigating the company for giving kickbacks to physicians to use the company’s tests. Additional allegations suggested a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.

In the latest development HDL terminated its contract with BlueWave Healthcare Consultants, the sales company that played a crucial role in HDL’s explosive growth. In response BlueWave filed a lawsuit against HDL for $205 million…

Click here to read the full post on Forbes.

 

Three Reasons Why You Don’t Need To Feel Sorry For Doctors Reply

I’m not a doctor and I don’t have strong opinions about how doctors should be certified or, more to the point right now, what they should have to do to maintain their certification over the course of their careers. But recently this last topic– called maintenance of certification, or MOC– has become the subject of a raging debate within the medical community, as thousands of doctors have expressed their displeasure, to put it mildly, with a new recertification scheme established last year by the American Board of Internal Medicine, the official “certifying” body of a large proportion of doctors in the US. From what I’ve read it appears that the critics of the new system have some very legitimate points and that some big changes will likely be necessary. But in the course of the debate I have been disturbed by some of the arguments that have been used to criticize the new MOC. (Unfortunately I haven’t seen a lot of attempts to actually defend the new scheme so I can’t give equal time to the other viewpoint.)

Click here to read the full post on Forbes.

 

FDA Approves New Oral Anticoagulant From Daiichi Sankyo 1

And then there were four.

Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace…

Click here to read the full post on Forbes, including a comment from Sanjay Kaul.

 

An Emerging Consensus About Novartis’s New Potential Blockbuster Reply

Last year it became clear that Novartis had a potential blockbuster with its new heart failure drug, LCZ696, which is an angiotensin receptor- neprilysin inhibitor (ARNi) consisting of the company’s own well-known angiotensin receptor blocker valsartan (Diovan) and a novel compound, the neprilysin inhibitor sacubitiril. The results of the PARADIGM trial, which was stopped early because of a large and highly significant reduction in cardiovascular mortality, electrified the cardiovascular community. But the trial also sparked a lot of controversy when skeptics raised questions suggesting that the results were not nearly as impressive as the investigators reported.

Following the initial excitement and discussion we are now starting to get a more measured and realistic view of the drug and the trial. In recent days two important secondary PARADIGM papers have been published. A paper in Circulation looks at the experience of trial participants who didn’t die. A paper in European Heart Journal performs some sophisticated statistical wizardry to estimate how LCZ696 would have performed against placebo instead of an active comparator. It will probably come as no surprise that both papers are highly positive. The Circulation paper shows that LCZ696 was effective in preventing progression of heart failure. The EHJ paper concludes that if it had been compared to placebo in a contemporary, otherwise well-treated population LCZ696 would have produced “striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization.”

Far more important than these papers, in my view, are the accompanying editorials. The Circulation editorialist, Henry Krum, is an influential Australian cardiologist and the EHJ editorialist, Duke University cardiologist Rob Califf, is one of the most influential and respected cardiologists in the world…

Click here to read the full post on Forbes.

 

Healthy Habits Of Young Women Lead To Long-Term Health Benefits 1

It may seem obvious but a new study shows that young women with healthy habits are less likely as they age to get coronary heart disease or go on to develop cardiovascular risk factors like high blood pressure, high cholesterol, or diabetes.

Andrea Chomistek and colleagues analyzed data from more than 88,000 women participating in the Nurses Health Study II and who were between 27 and 44 years of age at the start of the study.

Click here to read the full post on Forbes.

 

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FDA Approves New Medtronic Drug-Coated Balloon To Open Blocked Leg Arteries Reply

Medtronic said today that it had received approval from the FDA to market its In.Pact Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the upper leg. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication.

Click here to read the full post on Forbes.

 

MDT DCB

2014 Dubious Innovations In Cardiology Reply

 

  • Dubious Innovative Device: Renal Denervation
  • Dubious Innovative Business Strategy: Health Diagnostics Laboratory
  • Dubious Innovations In Leadership (Tie): The European Society of Cardiology and The Institute of Medicine
  • Dubious Innovative Breakthrough Therapy That Never Actually Breaks Through Anything (repeat winner): Cardiac Stem Cell Therapy

 

Click here to read the full post on Forbes.

 

 

Embattled Stem Cell Researchers Sue Harvard And Brigham And Women’s Hospital Reply

Two embattled and highly controversial stem cell researchers are suing the Brigham and Women’s Hospital and Harvard Medical School for an ongoing investigation into their research. The investigation has already resulted in the retraction of one paper in Circulation and an expression of concern about another paper in the Lancet.

The suit was filed by Piero Anversa, the highly prominent stem cell researcher who is a Harvard professor and the head of a large lab at the Brigham, and his longtime colleague, Annarosa Leri, an associate professor of medicine at Harvard who has coauthored many papers with Anversa. The suit places the blame for any scientific misconduct relating to the two papers on a third colleague and coauthor, Jan Kajstura, their longtime collaborator.

Click here to read the full post on Forbes.

 

New Devices May Bring Improved Treatment To Stroke Patients Reply

A large new trial provides the first substantial evidence that new devices can improve the outcome of patients who have acute ischemic stroke. Earlier, less sophisticated versions of the devices had produced disappointing results in clinical trials. The previous trials may also have been hindered by long treatment delays and difficulties in recruiting suitable patients. The new devices are retrievable stents that extract blood clots from inside vessels.

MR CLEAN (The Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), published in the New England Journal of Medicine today,  was designed to address the limitations of these previous trials. 500 patients with ischemic stroke were randomized to usual care or the addition of intraarterial treatment within 6 hours of symptom onset.

Click here to read the full post on Forbes.

 

Continuing Medical Education Payments To Physicians Will Be Exposed To Sunshine Reply

After a long and complicated struggle it now appears highly likely that industry will be required to disclose payments to physicians for continuing medical education (CME). This decision from CMS, which I am told by reliable sources is final, follows a long period in which CMS appeared to waver in its approach to incorporating CME into the Sunshine Act.

Click here to read the full post on Forbes.

 

No Advantage For Low Glycemic Index Diet Reply

In recent years the glycemic index (GI), a measure of a carbohydrate’s impact on blood sugar, has assumed a major role in discussions about diets and nutrition. Now a new study suggests that by itself, within the context of an otherwise healthy diet, GI may not be an important factor in improving cardiovascular risk.

In a paper published in JAMA, Frank Sacks and colleagues report the results of a randomized, crossover-controlled 5-week feeding trial comparing 4 different diets in 163 overweight or obese adults. The diets were either low- or high-carb and either low- or high-GI. Importantly, all the diets were based on previously established healthy dietary patterns based on the DASH diet, which is low in saturated and total fat and includes substantial amounts of fruits, vegetables, and low-fat dairy foods.

Click here to read the full post on Forbes.

 

Get Rid of Sugar, Not Salt, Say Authors Reply

Too much negative attention has been focused on salt and not enough on sugar, write two authors in Open Heart. Reviewing the extensive literature on salt and sugar, they write that the adverse effects of salt are less than the adverse effects of sugar. The evidence supporting efforts to reduce salt in the diet is not convincing and we would be far better off reducing sugar instead of salt in the modern diet.

Click here to read the full post on Forbes.

 

English: Macro photograph of a pile of sugar (...