Vampire Lab Turns To Old Trick To Grow Business: Physician Owned Labs

True Health Diagnostics, the new laboratory that bought the assets and adopted the business model of the disgraced and bankrupt laboratory company Health Diagnostic Laboratory (HDL), is turning to some old, unethical, and illegal tricks to grow its business. As I’ve reported previously, one key to the spectacular growth of HDL laboratory involved surreptitious bribes…

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Deals Seek To Link Entresto Cost To Effectiveness

For two large insurance companies payment for the new heart failure drug Entresto will be linked to its health benefits. Both Cigna and Aetna have confirmed that they have reached a pay-for-performance deal with the drug’s manufacturer, Novartis. According to  a press release issued by Cigna, “the pay-for-performance agreement ties the financial terms to how…

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The Real Losers In The Zombie Versus Vampire Lab Company Court Battle

Right now a dead, bankrupt and corrupt laboratory company is suing an active, morally bankrupt lab company. No matter who eventually wins the court battle all of us– patients, Medicare, insurance companies, not to mention our entire health and legal systems– will lose. Health Diagnostics Laboratory (HDL) is the zombie lab company. After raking in…

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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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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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