Four Senators Now Oppose Califf Nomination To Head The FDA

(Updated on January 26 and January 27) US Senator Edward Markey, a Democrat from Massachusetts, is seeking to block Rob Califf’s nomination to head the FDA, according to a report in the Boston Globe. Markey will use Senate rules to place a hold on the nomination. In September President Obama nominated Califf, a well-known Duke…

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New Lab Company Seeks To Bury Links To Zombie Lab And Rogue Sales Team

A new, rapidly growing laboratory company has been publicly linked to a disgraced and now bankrupt laboratory company and its sales team. Now the new company, True Health Diagnostics (THD), is trying to distance itself from that lab company, Health Diagnostic Laboratory (HDL), and its affiliated sales team, BlueWave. But THD’s claim of independence falls…

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Why Guidelines Are Bad For Science

 Bad guidelines don’t just give bad advice. They also harm science and impede research. The new US Dietary Guidelines– which I’ve already called a recipe for disaster— are a perfect example of why we need to have fewer, shorter, and, crucially, better guidelines. Back in 2014, in response to the controversy over salt guidelines, I…

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Editors Deliver Major Victory To Open Data Movement

The open data movement has gained its biggest victory yet. In an editorial published simultaneously in 14 major medical journals today, The International Committee of Medical Journal Editors (ICMJE) delivered a full-throated endorsement, in both actions as well as words, of data sharing by clinical researchers. Here is the core of the ICMJE proposal: As…

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Recipe For Disaster: The New US Dietary Guidelines

The science of nutrition is a disaster. For a variety of very good reasons it is nearly impossible to perform high quality, long term randomized controlled trials to provide satisfactory answers to most of the pressing questions of the day. But many experts are convinced they do know the answer to many of these questions….

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Some Come To Bury The Stethoscope, Some To Praise It

Is the stethoscope still an essential tool of modern medicine or is it an obsolete low-tech vestige of an antiquated era? There is, to say the least, a wide variety of opinions on the topic. On the one hand, technology enthusiasts argue that the stethoscope should be replaced by portable ultrasound devices. “The stethoscope’s 200th birthday should…

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Study Shows Why Sham Controls Are Necessary For Device Trials

— If we can melt the ice-caps then surely we can understand our own fallibility, says one UK cardiologist. The strongest known force in the universe is the ability of the human mind to deceive itself. If we know something to be true then we find the evidence to prove it. There is no better…

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Zombie Laboratory Company Sics Bill Collectors On Patients Promised Free Tests

(Updated) In several short years Health Diagnostic Laboratory (HDL) achieved spectacular growth partially on the promise to customers that they would never be responsible for the high costs of the company’s tests. Now, after bankruptcy and a forced sale of the company following multi-million dollar lawsuits by the Federal government and large private insurance companies, those same…

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Precision Medicine, Stuck In Second Grade, Flunks Test Of Clinical Utility

One of the great scientific achievements of the past generation has been the identification and characterization of the genetic underpinnings for many diseases. By combining genetic information with other forms of research doctors have been able to reach a much deeper understanding of many diseases. In a few cases genetic information has proved useful in screening…

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Rat Study Links Neural Tube Defects To Lower PCSK9 Levels

(Updated) PCSK9 may play an important role in neural tube development (NTD), a new study in rats suggests. The study, published in Scientific Reports, found that PCSK9 levels were significantly reduced in rat embryos with NTDs. The main focus of the paper was to identify biomarkers that could be used for the prenatal detection of NTDs, since there are now…

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Paper Raises More Questions About Salt Restriction In Heart Failure

Sodium restriction is a cornerstone of heart failure management, but many people would be surprised to learn that there is no good supporting evidence for the practice. In the 2009 heart failure guidelines sodium restriction in heart failure received a Class I recommendation (recommended), but this was based only on expert consensus (a C level of evidence of…

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2015: The Year We Finally Cured Heart Disease!

Editor’s note: Larry was too depressed to write the 2015 yearly review. Veteran healthcare journalist and eternal optimist Candide Corn volunteered to take over the task this year. Candide’s motto is “all is for the best in the best of all possible worlds.” What a great year for cardiology! The year brought us an unending…

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Meta-Analysis Gives More Support To Aggressive Blood Pressure Treatment

A large new meta-analysis offers fresh support to the growing movement in favor of more aggressive treatment to lower high blood pressure. The findings are consistent with and extend the results of the recently reported NIH SPRINT trial, which found substantial clinical benefits for a systolic blood pressure target of 120 mm Hg instead of 140…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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Amgen Denies Rumors About PCSK9 Inhibitors (Updated)

(Updated) Amgen says there is no truth to the rumor that the FDA is investigating post-marketing reports of serious brain infections in patients taking PCSK9 inhibitors. The Amgen statement was in response to this anonymous post on CafePharma: “The FDA informed Amgen and Regeneron today that there have been a number of post marketing reports…

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Prepublish or Perish? Making a Case for Medicine to Take a Cue from Basic Science

  It’s time for clinical research to join other scientific fields like physics and computer science and encourage preprint publication of manuscripts on the internet, according to three top cardiologists writing in a Lancet comment. Since 1969 researchers have labored under the constraints of the Ingelfinger rule, in which “posting a paper, data, or key findings on the internet represented presubmission…

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FDA Panel Turns Down Expanded Indication For Ezetimibe

An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret…

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Live Blog: The FDA Advisory Panel On IMPROVE-IT

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ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability

(Updated) In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not…

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Pioneering Cardiologist George Diamond Dead At 74

George Diamond, a pioneering cardiologist at the Cedars-Sinai Medical Center in Los Angeles, died on Saturday at the age of 74 from complications related to colon cancer. Here are some reactions to news of his death from several of his long-time friends and colleagues at Cedars-Sinai. Sanjay Kaul: “I am deeply saddened at the loss…

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Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe

You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the  cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to…

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More Concerns Raised About Possible Risks Of New Heart Failure Drug

(Updated with an additional comment from Milton Packer) More safety concerns are being voiced about Entresto, the new, ballyhooed heart failure drug from Novartis.  Fueling these concerns is a mix of speculation, worry about the FDA’s rapid approval of the drug, and a long-running feud between two leading heart failure researchers. The concerns, raised in a JAMA Viewpoint by heart failure…

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Survey: Docs Think Cardiologists Are Rude, Dismissive, And Aggressive

Nearly a third of English doctors report that they are subject to rude, dismissive and aggressive (RDA) behavior more than once a week. Cardiologists are among the specialists who are most likely to be responsible for this “workplace incivility.” These are some of the chief findings of a survey  published in Clinical Medicine of 606 British doctors at three…

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Prominent European Cardiologists Decry Curbs On Industry Support For Docs Attending Medical Meetings

(Updated) Starting in 2018 European device companies will no longer be allowed to directly sponsor physician attendance at medical meetings. In response, three prominent European interventional cardiologists warn that the change could have dire consequences, stifling education and potentially reducing attendance at European medical meetings by 30-50%. In the US physicians can still enjoy free meals….

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PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years

Treatment with Entresto (the combination of sacubitril and valsartan, formerly known as LCZ 696) instead of an ACE inhibitor will add approximately one to two years of life for most people taking the drug, according to new estimates published in the New England Journal of Medicine. Because of the time and population limitations of clinical trials it…

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