Another Diet Myth Exploded: Gradual Weight Loss No Better Than Rapid Weight Loss Reply

Once again, a popular weight loss myth has been exploded. It has been widely believed that weight loss, which is nearly always difficult to maintain, is even less likely to stay lost if it is the product of a rapid weight loss. The belief is even enshrined in current guidelines. Now a study published in The Lancet Diabetes & Endocrinology provides no support for this view. Instead, the study suggests that although long-term weight loss remains elusive regardless of the diet, short-term weight loss is actually more likely with rapid weight loss.

Click here to read the full post on Forbes.

 

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Inappropriate Heart Stress Tests May Waste Half A Billion Dollars A Year Reply

Inappropriate cardiac stress tests may cost the US healthcare system as much as half a billion dollars each year, according to a new study published in Annals of Internal Medcine.

Click here to read the full post on Forbes.

 

Nuclear medicine myocardial perfusion scan wit...

Nuclear medicine myocardial perfusion scan with Thallium-201 for the rest images (bottom rows) and Tc-Sestamibi for the stress images (top rows). The nuclear medicine myocardial perfusion scan plays a pivotal role in the noninvasive evaluation of coronary artery disease. The study not only identifies patients with coronary artery disease, it also provides overall prognostic information or overall risk of adverse cardiac events for the patient. (Photo credit: Wikipedia)

 

Medicare Reimbursement for Lung Cancer Screening Provokes Debate 1

Although 160,000 people in the U.S. die each year from lung cancer, accounting for more than a quarter of all cancer deaths, screening for lung cancer remains controversial. Based on results from the National Lung Screening Trial (NLST) in 2011, the U.S. Preventive Services Task Force (USPSTF) issued a B recommendation in favor of low-dose CT screening for high-risk current and former smokers. Due to a provision in the Affordable Care Act, private insurance is now mandated. More recently, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) concluded that there is only low to intermediate confidence that “there is adequate evidence to determine if the benefits outweigh the harms.” The Centers for Medicare and Medicaid Services (CMS) is expected to issue a final decision on national coverage in 2015.

Click here to read the full post on Forbes.

 

First Drug-Coated Balloon Approved By FDA For Leg Blockages Reply

The FDA today announced that it had approved for use in the US the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the thigh and knee (superficial femoral and popliteal arteries). The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012.

Click here to read the full post on Forbes.

 

FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device Reply

The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use.

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Novel Boston Scientific Device Headed For Another Rough FDA Panel Reply

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than a decade and its approval has twice been postponed by the FDA.  Briefing documents released ahead of Wednesday’s panel suggest that the third time may not be the charm for Watchman, though close FDA watchers believe the device may ultimately squeak through.

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Nissen Urges Prompt Revision Of Cardiovascular Guidelines Reply

Sparked by a new study that once again finds serious flaws in the cardiovascular risk calculator at the heart of the American College of Cardiology/American Heart Association cardiovascular guidelines, Steve Nissen states that “the ACC and AHA should promptly revise the guidelines to address the criticisms offered by independent authorities.” The CV risk calculator is a key component of the guidelines, since people are generally considered candidates for statins if they have a 10-year estimated risk of CV disease of 7.5% or higher according to the equations used by the calculator.

In a study published in JAMA Internal MedicineNancy Cook and Paul Ridker, analyzing data from the Women’s Health Study, offer fresh evidence that the cardiovascular risk calculator used in the ACC/AHA cholesterol guideline is flawed. They found that the predicted rate of cardiovascular disease using the guideline calculator was significantly higher than the actual observed rate in the trial. They considered and ruled out several “alternative explanations” for the discrepancy, including underascertainment of events and the increased use of statins and revascularization procedures in their population.

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Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future Reply

Cholesterol drugs, both new and old, are in the news again. There’s a lot going on now but the picture won’t really become clear until next month, when the results of a decade-old trial will finally be revealed. Briefly, here’s what’s happening:

  • Two new trials presented fresh evidence that PCSK9s, the much discussed new class of cholesterol drugs, have powerful LDL-lowering properties.
  • A new drug from Esperion, the phoenix of biotech companies, also showed promising results. The drug, ETC-1002, is a few years behind the PCSK9s in development but has some important theoretical advantages that may prove very important down the road.
  • At the annual meeting of the American Heart Association in November the results of the IMPROVE-IT trial will be presented. The results of this trial, as I have argued in the past, may have a broad if not decisive impact on the future of the PCSK9s and ETC-1002.

 …

Click here to read the full post on Forbes.

 

Study Suggests Vitamin D Can’t Prevent Diabetes Reply

A vitamin D pill can’t substitute for a healthy diet and sunshine, a new genetic study published in The Lancet Diabetes & Endocrinology suggestsIn recent years many people have been seduced by observational studies that found low levels of vitamin D in people who developed type 2 diabetes. The new study instead suggests that the association is not causal, and that raising vitamin D by itself will not be helpful.

Click here to read the full post on Forbes.

 

No Difference in Survival Found for Different Aortic Valve Prostheses Reply

new study published in JAMA suggests that younger patients who need aortic valve replacement (AVR) may now be more eligible to receive bioprosthetic valves. Each year about 50,000 people in the U.S. undergo AVR surgery. Older patients generally receive bioprosthetic valves because these valves are less prone to clotting and bleeding complications. Surgeons are often reluctant to use bioprosthetic devices in younger patients because these devices are more likely to deteriorate and require a repeat operation.

Researchers at Mt. Sinai Medical Center analyzed data from 4253 patients in New York State who were 50-69 years of age and who received a bioprosthetic or mechanical valve.

Click here to read the full post on Forbes.

 

 

American Heart Association: Pay More Attention to Radiation in Imaging Procedures Reply

The American Heart Association is urging physicians to better understand the risks of radiation in cardiac imaging procedures. When ordering these procedures physicians should understand the appropriate use of each procedure, the radiation dose associated with the procedure, and the risks associated with that dose. Both the risks and benefits should be fully explained and discussed with patients prior to the imaging procedure.

The full importance of radiation from cardiac procedures is not always appreciated, write the authors of the newly published scientific statement, “Approaches to Enhancing Radiation Safety in Cardiovascular Imaging.” But, according to Reza Fazel, the chair of the writing committee, “heart imaging procedures account for almost 40 percent of the radiation exposure from medical imaging.”

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Why Bad Doctors Are Like Bad Writers: The Curse Of Knowledge Reply

Steven Pinker, the Harvard psychologist and best-selling author, has a wonderful essay in the Wall Street Journal about why smart people are so often bad writers. Although the essay doesn’t touch on the subject of doctor-patient communication, every single word applies to doctors and the way they communicate (or fail to communicate) with their patients.

Here’s the core of Pinker’s argument. Read the rest of it. And if you’re a doctor and you don’t see how this is relevant to how you communicate with your patients then you need to think again.

Click here to read the full post on Forbes.

Click here to read the full essay by Steven Pinker in the Wall Street Journal.  

New England Journal Of Medicine Declines To Retract Papers From Disgraced Research Group 2

Like the Leaning Tower of Pisa, the two New England Journal of Medicine papers by disgraced Dutch researcher Don Poldermans will never stand straight. But like the famous Tower they are also unlikely to topple anytime soon. Without attracting a lot of attention, back in August the NEJM editors decided not to retract the papers or publish an expression of concern. But they did add an “Editor’s note” to the articles referring readers to a Dutch investigation into the studies.

Click here to read the full post on Forbes.

 

The Leaning tower of Pisa

The Leaning tower of Pisa (Photo credit: Wikipedia)

Embattled HDL Laboratory CEO Resigns Amid Federal Investigation Reply

Tonya Mallory, the embattled President and CEO of troubled Health Diagnostics Laboratory, has resigned her positions, the company announced today. Mallory said she was leaving to help her brother start a new business. Dr. Joe McConnell, a co-founder of the company and its Chief Laboratory Officer, will succeed her. Mallory will remain on the HDL Board of Directors.

As previously reported (by the Wall Street Journal and here) the federal government is investigating HDL for giving kickbacks to physicians  who use  the company’s tests. Additional allegations suggest a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.

Click here to read the full post on Forbes.

 

Tonya Mallory

 

 

 

A ‘Disappeared’ Article, Finally Published, Finds A Desultory Response To Scientific Misconduct Reply

Back in January an article in the European Heart Journal raising the disturbing possibility that guidelines based on fraudulent research may have been responsible for as many as 800,000 deaths was “disappeared” from the journal’s website only minutes after being published. The journal’s editor claimed the article had not been properly peer reviewed. In its place the editors published an editorial refuting the claims of the article, though of course they were responding to an article that no one could then actually read. Now, eight months later, a revised version of the original article, by British cardiologists and gadflies Graham Cole and Darrel Francis, has finally been published. The new version raises even more disturbing questions about the potentially lethal effects of such fraudulent research not only on clinical practice but on the credibility and worth of the entire scientific enterprise.

Click here to read the full post on Forbes.

 

Cardiology Group Withdraws ‘Choosing Wisely’ Recommendation Reply

In the end it wasn’t wisdom for the ages. The American College of Cardiology said today that it was withdrawing one of its five recommendations in the “Choosing Wisely” campaign.  In 2012 the ACC recommended that heart attack patients should have only their culprit artery unblocked. It said that patients and caregivers should question whether complete revascularization of all nonculprit lesions in heart attack patients should be performed.

The original recommendation was based on non-randomized studies suggesting that treating all significantly blocked vessels in heart attack patients could be harmful. “However,” the ACC now states, “over the last two years, new science has emerged showing potential improvements for some patients in their overall outcomes as a result of complete revascularization.”

Click here to read the full post on Forbes.

 

Counterintuitive Advice About Staying Alive After A Heart Attack 1

An interventional cardiologist– the cardiologists who put in stents and usually treat heart attack patients in the first few hours– asked an electrophysiologist– the cardiologists who treat arrhythmias– whether wearable defibrillators should be used post-MI. Here’s what that electrophysiologist, Edward J. Schloss, the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH, replied. It is a good example of how sometimes a procedure or a therapy that seems, intuitively, to be worthwhile and beneficial, may actually not be beneficial at all. Here’s his response, which he originally posted on Twitter:

Click here to read the full post on Forbes.

 

Way Beyond Kickbacks: More Serious Misconduct Alleged Against Medical Testing Company Reply

The problems go way beyond kickbacks. As previously reported (here and in the Wall Street Journal) the US government is conducting an investigation into Health Diagnostic Laboratory, a medical laboratory testing company that has enjoyed explosive growth since its founding in 2008. Previous reports centered on kickbacks given to physicians by the company to encourage greater use of the company’s tests. The new allegations suggest a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.

The main new accusation involves HDL’s sales force, who work for an independent but closely related company known as BlueWave Healthcare Consultants Inc. These salesmen persuade physicians and other healthcare providers to order a whole host of unnecessary tests from HDL and, often, from other lab companies as well, including Singulex and Innovative Diagnostic Laboratory (IDL). As the WSJ article explained, kickbacks to physicians occur when the companies give excessive process and handling (P&H) fees instead of the $3 “draw” fee generally allowed by Medicare. My sources inform me that by combining multiple tests from multiple companies these fees can climb to as much as $100 per patient. This is called “stacking.”

To prevent patients and insurers from looking too closely at these practices the company has a policy of rarely if ever requesting co-payments from patients. Therefore the physicians profited from the kickbacks and the company benefited by collecting the portion of the charges which escape scrutiny from insurance companies and Medicare. Both the promotion of unnecessary tests and the refusal to collect co-payments are illegal and unethical, say experts.

Click here to read the full post on Forbes.

 

Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill Reply

After nearly a year of uncertainty, Amarin  announced  its commitment to complete REDUCE-IT  (Reduction of Cardiovascular Events with EPA – Intervention Trial). The trial is designed to test the effects on cardiovascular outcomes of Vascepa, the company’s high EPA omega-3 prescription fish oil product, in people with moderately elevated triglyceride levels between 200-499 mg/dL.

Last year the company said it might discontinue support of the trial, which began in 2011, after the FDA turned down the company’s application for an expanded indication for Vascepa.

Click here to read the full post on Forbes.

 

Cheaper Generic Statins Beat Brand-Name Statins in Adherence and Outcomes Reply

A large observational study finds that people who received a prescription for a generic statin were more likely to take their pills than people who received a prescription for a brand-name statin. This increased adherence appeared to lead to a small but significant improvement in outcomes.

Click here to read the full post on Forbes.

 

ACC And AHA Don’t Recommend Routine ECG Screening Of Young People Reply

In a new scientific statement the American Heart Association and the American College of Cardiology do not recommend the routine initial use of ECGs to screen young people for underlying congenital or genetic heart disease.

More aggressive screening for heart disease in young people is often advocated in response to pressure resulting from the rare but tragic cases of sudden death in young people. But a detailed examination of the evidence led the AHA/ACC group to conclude that routine initial ECG screening “in healthy people 12-25 years old without positive findings on the history and physical examination has not been shown to save lives.”

Click here to read the full post on Forbes.

 

Japanese Research Scandal Involving Novartis Blood Pressure Drug Widens Reply

The Japanese scandal over research using the Novartis blockbuster hypertension drug Diovan (valsartan) continues to widen. The first major figure brought down in the scandal was Hiroaki Matsubara, a prominent cardiologist and researcher at Kyoto Prefectural University in Japan, who  resigned from his position after numerous retractions and investigations. Then last year accusations surfaced about another prominent researcher, Issei Komuro, a professor at Chiba University.

Chiba University has now completed an investigation of one of Komuro’s most important papers, the 2011 report of the Valsartan Amlodipine Randomized Trial (VART), published in Hypertension Research, which is the official journal of the Japanese Society of Hypertension.

Click here to read the full post on Forbes.

 

 

 

FDA Approves New Weight Loss Drug From Orexigen And Takeda Reply

The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug.  The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment. Contrave is manufactured by Orexigen and will be distributed by Takeda.

Click here to read the full post on Forbes.

 

FDA Advisory Panel Offers Cautious Support For Polypill Reply

The controversial polypill took one step closer to reaching the US market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for more than a decade and has attracted considerable doses of support as well as skepticism.

An all-star group of cardiology leaders– including Sir Nicholas Wald, Salim Yusuf, Suzanne Oparil, Sidney Smith, and Clyde Yancy– helped provide the spoonful of sugar that helped the committee swallow the polypill. The FDA also eased the way by limiting the discussion to the use of the polypill for secondary prevention in people who have already had a MI or a stroke.

Click here to read the full post on Forbes.