FDA Announces Sweeping Changes In Approach To Opioid Drugs

The FDA announced today that it planned sweeping changes in its approach to opioids drugs. The move comes in response to growing concerns over abuse of prescription opioids in the US and escalating criticism of the FDA’s lackluster response to the problem. Two US Senators have said they would oppose President Obama’s nomination of Robert…

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New Studies Seek To Allay Concerns Over The ROCKET-AF Trial

New post-hoc analyses of ROCKET-AF confirm the main results of the controversial trial, according to a paper published in the New England Journal of Medicine. The papers are a response to disturbing questions about the trial raised last fall. But the new analyses will not fully satisfy some critics of the trial who are calling for…

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Entresto Maker In Deep Water Over Terrifying TV Advertisement

Updated with comments from Novartis and Mary Knudson– A Novartis television commercial and advertising campaign is terrifying millions of people and provoking sharp criticism from doctors. The critics include Milton Packer, a top expert who ran the main trial testing the company’s big new heart failure drug, Entresto. The ad depicts a middle-aged man in…

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Slow Start For ‘Blockbuster’ Heart Failure Drug Entresto

Entresto, the new heart failure drug from Novartis that is widely expected to be a blockbuster, is off to an exceptionally slow start. Approved last July, the drug, formerly known as LCZ 696, had sales of only $21 million in 2015, only $5 million of which came in the fourth quarter. Despite low expectations in the early…

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A Lab Industry Veteran Deciphers The Zombie Lab Enigma

True Health Diagnostics (THD) is the new, rapidly growing lab that bought the assets of the disgraced and bankrupt Health Diagnostic Lab (HDL). (See the bottom of this story for links to my previous coverage of this story.) I asked one industry veteran for his thoughts on THD’s business practices and the relationship between THD…

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NEJM Editor Flip Flops On Data Sharing After Social Media Firestorm

After a firestorm of criticism on social media over his editorial comments,  Jeffrey Drazen, the editor-in-chief of the New England Journal of Medicine, is trying to quiet a growing controversy by modifying his position regarding shared data. The firestorm was ignited by an editorial on data sharing in last week’s NEJM. Although highly supportive of…

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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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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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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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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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New Questions Raised About ROCKET AF, Pivotal Xarelto Trial Chaired By Califf

(Updated) Disturbing questions are being raised about the integrity and reliability of crucial data in the ROCKET AF trial. The investigation could have important implications on several fronts. First, the trial serves as the basis for the use of the blockbuster drug rivaroxaban (Xarelto, Johnson & Johnson) for stroke prevention in atrial fibrillation. Second, the…

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Novartis Heart Failure Drug Gains Approval In Europe

Entresto, the novel heart failure drug from Novartis, has now been approved in Europe. The company said the drug, a twice-a-day combination of sacubitril and valsartan (formerly known as LCZ 696), had been approved by the European Commission for the treatment of people with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). The news follows previous approval of the drug by…

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Amgen’s Repatha Beats Out Competitor For Spot On CVS/Caremark Formulary

CVS Health announced today that Amgen’s Repatha will be the only PCSK9 inhibitor on the CVS/Caremark formulary. This gives Amgen its first big win among the pharmacy benefits managers against Sanofi’s Praluent in the battle over the market for the powerful but expensive new cholesterol-lowering drugs. Previously Express Scripts had announced that both drugs would be placed…

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Experts Question Role For At-Home Statin Intolerance Test

A small laboratory company, Boston Heart Diagnostics, has introduced and is promoting “the first and only at-home saliva laboratory developed test” that it says will help identify people who are likely to experience side effects from taking a statin. The company claims the genetic test “helps patients understand how their bodies will process a statin…

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