At the FDA Rob Califf Will Champion Clinical Trials
Everyone wants to know what Rob Califf is going to do at the FDA. His critics say he’s going to hand the car keys over to industry and allow them to drive the agenda. Or, as one reporter tweeted: Hey, is that the sound of the FDA approving things faster? Must be because the Senate...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 25, 2016 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics Califf FDA Source Type: blogs
Vulnerable Plaque: The Paradigm That Failed
Is it a hallowed paradigm or a hype-othesis? The “holy grail” of cardiology is to stop heart attacks before they happen by identifying– quickly, noninvasively, and specifically– those coronary artery lesions that result in heart attacks. The key theoretical underpinning driving this goal has been the vulnerable plaque hypothesis, which holds that the vast majority...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 24, 2016 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery Policy & Ethics Prevention, Epidemiology & Outcomes stents vulnerable plaque Source Type: blogs
Slow Down. Don’t Sprint To More Aggressive BP Treatment
Two editorialists in Annals of Internal Medicine urge caution in interpreting and adopting the findings of the SPRINT (Systolic Blood Pressure Intervention Trial), which last year showed a benefit for a more aggressive approach to blood pressure therapy. The trial found improved outcomes in high risk patients treated to a target of of 120 mm...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 22, 2016 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes Uncategorized antihypertensive therapy blood pressure SPRINT Source Type: blogs
FDA Turns Down Expanded Indication For Zetia And Vytorin
The FDA has turned down Merck’s application to expand the indication for its cholesterol-lowering drug ezetimibe (Zetia and Vytorin, Merck). This means there’s still no end in sight for this drug’s very long and very winding road. Ezetimibe is now indicated to reduce LDL cholesterol in people with hyperlipidemia. The proposed new indication was for...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 16, 2016 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes ezetimibe FDA IMPROVE-IT vytorin Zetia Source Type: blogs
Study Finds No Improvement In Quality Of Life With ESAs
Erythropoietin-stimulating agents (ESAs) continue to be widely prescribed despite the absence of evidence demonstrating benefit. TREAT– the first and only large trial to test clinical outcomes with the drugs–showed that ESAs did not reduce clinical events, though it did raise concerns that the drugs might increase the risk of stroke. Critics say that the drugs...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 15, 2016 Category: Cardiology Authors: Larry Husten Tags: Diabetes Policy & Ethics Prevention, Epidemiology & Outcomes anemia chronic kidney disease CKD dialysis Erythropoietin ESAs Source Type: blogs
US Freezes Millions Of Dollars In Assets Of Rogue Lab Sales Force
The US government is freezing millions in dollars in assets from the owners of BlueWave, the sales company that participated in “a massive kickback scheme” involving Health Diagnostics Laboratory (HDL) and a second smaller laboratory company, Singulex, Inc. A US judge last week granted an application from US and state attorneys to ensure that BlueWave...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 14, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics BlueWave Health Diagnostic Laboratory kickbacks True Health Diagnostics Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 11, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Uncategorized HDL Health Diagnostics Laboratory True Health Diagnostics Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 9, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Policy & Ethics Prevention, Epidemiology & Outcomes Aetna Cigna Entresto Novartis Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 8, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics BlueWave HDL Health Diagnostics Laboratory THD True Health Diagnostics Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 4, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Califf FDA opioids Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 3, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Policy & Ethics INR rivaroxaban ROCKET-AF Xarelto Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - February 2, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Policy & Ethics commercials disease awareness Entresto Novartis Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - January 28, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events Uncategorized Entresto LCZ 696 Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - January 27, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics BlueWave HDL HDL Lab THD True Health Diagnostics Source Type: blogs
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...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - January 25, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Uncategorized data sharing Drazen NEJM new england journal of medicine open science research parasite Source Type: blogs
