Paper Behind The Green Coffee Bean Diet Craze Retracted Reply

The “scientific” paper that helped ignite the green coffee bean diet craze has been retracted. The details of the retraction and the full background of the story were fully reported by Ivan Oransky on Retraction Watch.

The paper, published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, purported to report the substantial weight loss findings of a randomized, double-blind, placebo-controlled crossover study of green coffee bean extract. The article has been viewed or downloaded by more than three-quarters of a million people since its publication in January 2012.

Click here to read the full post on Forbes.

 

English: Photo of Dr.Oz at the Time 100 Gala.

English: Photo of Dr.Oz at the Time 100 Gala. (Photo credit: Wikipedia)

 

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Cigna Sues Embattled HDL Laboratory For $84 Million Reply

The Cigna Health and Life Insurance company is suing Health Diagnostic Laboratory Inc. for $84 million.  As reported previously, the embattled lab company is the subject of an ongoing Federal investigation concerning kickbacks and fraudulent billing.

The charges against HDL in the suit filed last week in federal court closely echo the earlier allegations against the company.

Click here to read the full post on Forbes.

 

Previous Stories About HDL:

Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack! Reply

Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals, including a patient and a health care provider, whose stories appear to confirm and provide additional perspective about the allegations in the earlier articles.

“Your test results are giving me a heart attack!”

Click here to read the full post on Forbes.

 

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.

 

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 Reply

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.

 

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.

Click here to read the full post on Forbes.

 

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.

 

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.”

Click here to read the full post on Forbes.

 

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

 

 

 

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.

 

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.

 

Statins And Diabetes: A Clearer Picture Emerges Reply

In recent years, the medical community has become increasingly aware that taking statins can result in slightly higher glucose levels, and this can lead to a diagnosis of diabetes in a small but statistically significant number of people. But it has been unclear whether the diagnosis of diabetes in people taking statins also places them at increased risk for the microvascular complications linked to diabetes. Now, an observational study published in the Lancet Diabetes & Endocrinology finds that among people newly diagnosed with diabetes, statin users are less likely than nonusers to develop most of these complications. (The beneficial effects of statins in reducing macrovascular complications — cardiovascular disease — in diabetics and others is well established in people at high risk for these events.) 

Danish researchers examined the rate of microvascular outcomes in more than 15,000 statin users who developed diabetes and 47,000 nonusers of statins who developed diabetes.

Click here to read the full post on Forbes.

 

Beyond Kickbacks: More Questions About Unnecessary Cardiovascular Tests Reply

On the front page of the Wall Street Journal today is an important story about a fast-growing company accused of giving kickbacks to physicians who order the company’s tests measuring a wide variety of cardiovascular biomarker tests. But the article leaves one major question unasked: even if the company played fully by the rules, are most of the tests medically necessary?

In their story John Carreyrou and Tom McGinty write about a government investigation into Health Diagnostic Laboratory Inc. (HDL), which was started in 2008 and had $383 million in revenue last year. HDL sells tests that measure cardiovascular biomarkers and “bundles together up to 28 tests it performs on a vial of blood, receiving Medicare payments of $1,000 or more for some bundles.”

Click here to read the full post on Forbes.

 

Early Hint At Cardiovascular Outcomes With Sanofi’s and Regeneron’s Rapidly Advancing Cholesterol Drug Reply

Amid a slew of new data demonstrating yet again that PCSK9 inhibitors lower LDL cholesterol– drastically and in a wide variety of different patient populations– data from one trial offers the first suggestion that the drugs may in fact improve cardiovascular outcomes. But the analysis, the authors cautioned, is a post-hoc analysis of a trial neither designed nor powered to study outcomes, so should be considered preliminary and speculative at best.

Four phase 3 trials with the Sanofi and Regeneron PCSK9 inhibitor alirocumab (pronounced “allee rock you mab” by Chris Cannon at a news conference) were presented today at the European Society of Cardiology meeting in Barcelona.

Click here to read the full post on Forbes.

 

Rise In Popularity Of E-Cigarettes Sparks Concerns And Recommendations Reply

The recent dramatic rise in popularity of e-cigarettes threatens to reverse hard-fought progress in the war against smoking, according to a new policy statement from the American Heart Association. “E-cigarettes have caused a major shift in the tobacco-control landscape,” said the lead author of the statement, Aruni Bhatnagar, chair of cardiovascular medicine at the University of Louisville.

But the AHA did not completely reject the use of e-cigarettes as an aid to stop smoking.

Click here to read the full post on Forbes.

 

Why Guidelines Should Be Waged Like War 1

Here’s a modest proposal: we need fewer and shorter guidelines. In fact, I’d like to propose that guidelines, like war, should be waged only when there is absolute consensus and overwhelming evidence.

Anyone interested in the subject is aware that guidelines are in a complete mess.

Click here to read the full post on Forbes.

United Nations Security Council Resolution 707

United Nations Security Council Resolution 707 (Photo credit: Wikipedia)

 

FDA Grants New Indication For Apixaban Reply

The FDA today approved an expanded indication for  the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy.

Click here to read the full post on Forbes.

Increased Heart Risk Linked To Popular Antibiotic Reply

Acute use of the popular macrolide antibiotic clarithromycin has been linked to a small but significant increase in cardiac death. In a report in the BMJ, researchers in Denmark analyzed the effects over a 14-year period of the acute use of penicillin V, roxithromycin, and clarithromycin.

Earlier research raised concerns that marcrolide antibiotics in general, and erythromycin and azithromycin in particular, might prolong the QT interval and increase the risk for fatal arrhythmias.

In the new study, clarithromycin was associated with a significant increase in the rate of sudden cardiac death compared with the other two antibiotics…

Click here to read the full post on Forbes.

 

An Old Study Fuels Debate Over Blood Pressure Guidelines Reply

In the last year new guidelines relating to cardiovascular disease have been the subject of intense criticism and debate. The status of the blood pressure guidelines has been particularly contentious, since several different groups have published contradictory guidelines, while several authors of the most prominent group, the Eighth Joint National Committee, published an impassioned dissent from their own published guideline. Many hypertension experts have taken aim at the change in therapeutic target for systolic blood pressure in patients age 60 or older, from 140 mm Hg to 150 mm Hg.

In an attempt to determine the optimal blood pressure for patients age 60 or older, Sripal Bangalore and colleagues performed a post-hoc analysis of 8,354 patients who participated in the INVEST trial, who were age 60 or older, and who had a baseline systolic blood pressure greater than 150 mm Hg…

Click here to read the full post on Forbes, including comments from Sripal Bangalore and Harlan Krumholz.