Interventional Cardiology And The Rejection Of Science
–Prominent interventional cardiologist says clinical trials are slowing progress In their eagerness to embrace a glorious future of ever more spectacular technology-based advances, interventional cardiology— a subspecialty never exactly known for caution, patience, or self reflection— is poised to reject science, evidence-based medicine, and randomized controlled trials. “Generating and publishing evidence is a tedious job,”...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 22, 2016 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics clinical trials Evidence-based medicine PFO closure RCTs renal denervation stents Source Type: blogs

The Billion Dollar Lab Scandal
If you think Theranos is a big story then I have some news for you. There’s another medical laboratory scandal  that dwarfs the Theranos story by almost any standard except for hype. The Theranos story is an important sexy Silicon Valley story. It’s more about an imagined  shimmering future than about the greasy present we actually...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 18, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics DOJ HDL Lab Health Diagnostics Laboratory lab scandal Theranos Source Type: blogs

Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy
–FDA says the manufacturer has not demonstrated that it has fixed the problem. The  Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 13, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Alere anticoagulation FDA INR monitoring system ROCKET-AF Source Type: blogs

Reality Check On The ‘ Noninferior ’ Abbott Bioresorbable Stent
–The slippery slope of noninferiority. Last week the big news in interventional cardiology was the approval of Abbott’s bioresorbable stent, Absorb. There’s no doubt that this represents a remarkable technical achievement, propping open a clogged artery and then gradually disappearing. There are all sorts of theoretical reasons why this might represent an important advance over traditional stents that...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 12, 2016 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics Abbott ABSORB bioresorbable stent noninferiority stents Source Type: blogs

Reality Check On The ‘Noninferior’ Abbott Bioresorbable Stent
–The slippery slope of noninferiority. Last week the big news in interventional cardiology was the approval of Abbott’s bioresorbable stent, Absorb. There’s no doubt that this represents a remarkable technical achievement, propping open a clogged artery and then gradually disappearing. There are all sorts of theoretical reasons why this might represent an important advance over traditional stents that...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 12, 2016 Category: Cardiology Authors: Larry Husten Tags: Interventional Cardiology & Surgery People, Places & Events Policy & Ethics Abbott ABSORB bioresorbable stent noninferiority stents Source Type: blogs

Repatha Approved for Single Monthly Injection
–New hands-free system replaces three sequential shots The FDA has approved a device that can deliver a single monthly injection of evolocumab (Repatha), the cholesterol-lowering PCSK9 inhibitor manufactured by Amgen. Repatha is currently administered by subcutaneous injection in a 140-mg dose every 2 weeks or as a 420 mg monthly dose. Until now, the monthly...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 12, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events cholesterol PCSK9 Repatha Source Type: blogs

The Wild West Of New Laboratory Scams
It’s like the wild west. With no sheriff acting to impose law and order, many laboratory companies are now deploying a wide variety of new scams to gain new business. The new scams have emerged in the wake of the collapse and bankruptcy of Health Diagnostics Laboratory (see the bottom of this story for links to previous coverage)...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 11, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics DOJ HDL Laboratory kickbacks True Health Source Type: blogs

ROCKET AF Investigators Say New Analysis Supports Original Trial Results
–Test of stored blood may help answer troubling questions about the trial. A new analysis of stored blood by the ROCKET AF trial investigators may help resolve lingering questions about the trial. The questions about ROCKET AF, which compared rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation, emerged last November, when...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 6, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Policy & Ethics anticoagulants INR rivaroxaban Xarelto Source Type: blogs

Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists
At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists.    An FDA advisory panel last week turned out to be a much more contentious and divided than many had expected. Based on the FDA’s own analysis of last year’s Empa-Reg Outcome trial I had predicted that the...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - July 5, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics CVOT diabetes empagliflozin FDA advisory panel glucose Source Type: blogs

FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug
Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - June 30, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes bempedoic acid cholesterol Esperion ETC-1002 FDA approval LDL Surrogate endpoint Source Type: blogs

Bad News Bears: After Scary Headlines Some Patients Stopped Taking Statins
Study provokes discussion about the responsibilities of medical journals and the general media. A new study and surrounding discussion raises important questions about the role and responsibility of researchers, editors, and journalists when tackling topics with potentially life-affecting consequences. The new study, published in the BMJ, found that many people stopped taking statins in the...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - June 28, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics Prevention, Epidemiology & Outcomes BMJ media media responsibility retractions statins Source Type: blogs

Empagliflozin May Be Poised To Gain CV Indication
–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - June 24, 2016 Category: Cardiology Authors: Larry Husten Tags: Diabetes People, Places & Events advisory panel CVOT empagliflozin FDA outcomes trials Source Type: blogs

Unforced Error: Pharma Supporter Attacks The Wrong Paper
If you’re going to attack a position you don’t like and also attempt to claim the moral and intellectual high ground it’s a good idea to get your basic facts rights. Even more– and it’s so obvious it shouldn’t need to be said– if it’s a scientific paper you are attacking you need to make sure you’re...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - June 24, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics CME conflict of interest free lunch medical communications Source Type: blogs

Time For Cardiologists To Start Prescribing Diabetes Drugs?
There’s an emerging consensus that now may be the time for cardiologists to start thinking seriously about prescribing diabetes drugs. Until now most cardiologists have not considered this to be part of their job description. But now new data from large cardiovascular outcome trials (CVOTs) shows that these drugs may one day become, like statins and...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - June 22, 2016 Category: Cardiology Authors: Larry Husten Tags: Diabetes Policy & Ethics Prevention, Epidemiology & Outcomes Uncategorized diabetes drugs empagliflozin liraglutide Source Type: blogs

The Hidden Cost Of Free Lunch
–Brand name prescribing increases when industry pays for the meals Physicians who accept free meals from a drug company are more likely to prescribe that company’s brand name drugs, according to a new study in JAMA Internal Medicine. The authors compared data from the Open Payments Database listing industry payments to physicians with Medicare prescribing...Click here to continue reading... (Source: CardioBrief)
Source: CardioBrief - June 20, 2016 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Policy & Ethics CMS conflict of interest free lunch Open Payments Sunshine Act Source Type: blogs