Johnson and Johnson 2013 Settlement and Corporate Integrity Agreement
On November 4, 2013, the Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and its pharmaceutical subsidiaries signed settlement agreements to pay more than $2.2 billion to resolve criminal and civil investigations into unapproved, or "off-label," promotion of three drugs and alleged kickbacks to physicians and nursing home pharmacies over a ten-year period. In 2012, we reported on the largest health care fraud settlement in U.S. history: $3 billion paid by GlaxoSmithKline.  According to the Associated Press, the J&J global settlement is the third-largest health care fraud settlement in U.S...
Source: Policy and Medicine - November 5, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

Boston Scientific Granted CE Mark for Lotus Minimally Invasive Aortic Valve System
Boston Scientific has been awarded CE Mark approval for their Lotus Valve System, used to treat patients with aortic stenosis who are considered too high risk for invasive cardiothoracic surgery. The implant itself is a stent-mounted tissue valve prosthesis, and the delivery system and introducer sheath have a low cross-sectional profile design to allow physicians greater control during the operation. The device is also introducing a couple unique technologies for TAVR (transcatheter aortic valve replacement) devices. It is the only aortic valve device that physicians can position, see how it’s doing, and then reposi...
Source: Medgadget - October 30, 2013 Category: Technology Consultants Authors: Nishey Wanchoo Tags: Cardiac Surgery Cardiology Source Type: blogs

Who Is Responsible?
But doctor, ultimately it is your responsibility. I can hear the case coordinator clicking her fingernails against the desk through the telephone line. I admit, I forgot to specify to the nurse, when she called me ten minutes before midnight, that this was a full admission and not an observation. In the absence of my order, a nurse manager reviewed the chart and decided that the ninety five year old woman with congestive heart failure and positive cardiac markers was appropriate for observation status. Of course the order can be changed, but one day will be lost. She will have to stay in the hospital an extra night in ord...
Source: In My Humble Opinion - October 14, 2013 Category: Family Physicians Authors: Jordan Grumet Source Type: blogs

CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel
The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System.  The small implantable device provides provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that the device had not been shown to be effective, and 6-4 that the benefits did not outweigh the risks. Now, two years, later, the vote wasn’t much different: the panel agreed unanimously (11-0) that the device was safe; 7-4 ...
Source: CardioBrief - October 9, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure People, Places & Events FDA food and drug administration Pulmonary artery Pulmonary artery pressure st jude medical Source Type: blogs

Medical Mispronunciations and Misspelled Words: The Definitive List.
Hearing medical mispronunciations and seeing misspelled words are an under appreciated  joy of working in healthcare.  Physicians often forget just how alien the language of medicine is to people who don't live it everyday.  The best part about being a physician is not helping people recover from critical illness. The best part is not  about  listening and understanding with compassion and empathy.  Nope, the best part about being a physician is hearing patients and other healthcare providers butcher the language of medicine and experiencing great entertainment in the process.   Doctors c...
Source: The Happy Hospitalist - October 2, 2013 Category: Internists and Doctors of Medicine Authors: Tamer Mahrous Source Type: blogs

Thoughts on diagnosis – reflections of #SIDM2013
Having spent the past 2 days at the 6th annual Diagnostic Errors in Medicine Conference, many thoughts have percolated as I reflect on the meeting. The conference had over 200 attendees and at such meetings one learns as much from hallway conversations as from the actual presentations. The Society to Improve Diagnosis in Medicine is filling an important void – the emphasis on proper diagnosis. Back in the day (the 1970s and before), diagnosis was clearly job #1. Somehow focus shifted away from correct diagnosis to management strategies, performance measures and report cards. Wonks and politicians assume that we c...
Source: DB's Medical Rants - September 25, 2013 Category: Health Medicine and Bioethics Commentators Authors: rcentor Tags: Medical Rants Source Type: blogs

Arrhythmia Masquerading as Cardiac Ischemia
A 45-year-old woman with a history of medication-controlled essential hypertension, stage 2 chronic kidney disease, type 2 diabetes mellitus, and a pack-a-day cigarette habit presented less than 60 minutes after acute onset of severe shortness of breath that awoke her from sleep. She had felt well the previous day, and went to bed with no complaints.   Around 4 a.m., she woke up from sleep very dyspneic, with moderate chest “discomfort” over her left chest that radiated to her back and was unchanged by position or respirations. She denied other symptoms such as fever, cough, nausea, vomiting, numbness, or abdominal pa...
Source: Spontaneous Circulation - September 12, 2013 Category: Emergency Medicine Tags: Blog Posts Source Type: blogs

Arrhythmia Masquerading as Cardiac Ischemia
A 45-year-old woman with a history of medication-controlled essential hypertension, stage 2 chronic kidney disease, type 2 diabetes mellitus, and a pack-a-day cigarette habit presented less than 60 minutes after acute onset of severe shortness of breath that awoke her from sleep. She had felt well the previous day, and went to bed with no complaints.   Around 4 a.m., she woke up from sleep very dyspneic, with moderate chest “discomfort” over her left chest that radiated to her back and was unchanged by position or respirations. She denied other symptoms such as fever, cough, nausea, vomiting, numbness, or abdominal ...
Source: Spontaneous Circulation - September 12, 2013 Category: Emergency Medicine Tags: Blog Posts Source Type: blogs

Day 4 ESC 2013 — Female gender and AF, patient selection for CRT and a Dutch cycling adventure
On the last day of ESC2013 I attended a press conference entitled Update in Rhythmology. The purpose was to highlight four rhythm-related studies released at ESC2103. The most noteworthy of the four abstracts involved gender-related issues in atrial fibrillation therapy. French researchers used a 1.6 million patient database (including 1200 French GPs) to come up with about 15,000 atrial fibrillation patients. They then compared the rates of anticoagulation in men and women. There were significant differences–a gender gap if you will. The research team used the words, French women with AF undertreated. I wondered, is...
Source: Dr John M - September 6, 2013 Category: Cardiology Authors: Dr John Source Type: blogs

The Anatomy Of A Hospital Admission
If Hattie had but one flaw, it was that she held her doctors in too high esteem. It was not unusual for an eighty year old woman of her culture to want to please her cardiologist. So when her blood pressure came up a little high, she was too embarrassed to admit that she had forgotten to pick up the toprol and hadn't taken it in over a week. The cardiologist hemmed and hawed, he buried his head in the computer, and eventually wrote for norvasc, a new blood pressure medication. What he didn't do was ask about whether she had regularly taken her pills. He also forgot to tell her that leg swelling is a side effect of the medi...
Source: In My Humble Opinion - September 2, 2013 Category: Family Physicians Authors: Jordan Grumet Source Type: blogs

Heart disease 101: AF and Coronary Artery Disease — related, incidental or both?
There were many good questions raised on my last post. Thanks. One particularly relevant theme concerned the relationship of atrial fibrillation (AF) and coronary artery disease (CAD). There’s a great deal of misunderstanding out there on how these two common disease relate to each other. I thought a few paragraphs might be useful. On the matter of ‘arrhythmia’ and coronary artery disease: I stated in the George Bush piece that a good reason to open a partially occluded artery with a stent was to treat an arrhythmia. I should have said ventricular arrhythmia or ventricular tachycardia (VT). I told you a ...
Source: Dr John M - August 15, 2013 Category: Cardiology Authors: Dr John Source Type: blogs

The Beautiful Disruption: How Open Health Care Data Puts Patients in Charge
Health care is on the verge of a beautiful disruption. Technology is driving a liberation of data that will fundamentally change our relationship with our patients. In this brief blog, we’ll: look at technology’s effects on grocery stores (and why we should care), highlight some innovative companies that are disrupting health care, and put it all together to recognize how patients will command more control over health care decisions and spending. But first—grocery stores. Grocery Store Technology Once upon a time, grocery store employees spent an evening each month counting the cereal boxes left upon the ...
Source: richard[WINTERS]md - August 11, 2013 Category: Universities & Medical Training Authors: Richard Winters MD Tags: Uncategorized Source Type: blogs

The Beautiful Disruption: How Open Health Care Data Puts Patients in Charge
Health care is on the verge of a beautiful disruption. Technology is driving a liberation of data that will fundamentally change our relationship with our patients. In this brief blog, we will: look at technology’s effects on grocery stores (and why we should care), highlight some innovative companies that are disrupting health care, and put it all together to recognize how patients will command more control over health care decisions and spending. But first—grocery stores. Grocery Store Technology Once upon a time, grocery store employees spent an evening each month counting the cereal boxes left upon the shelf...
Source: richard[WINTERS]md - August 11, 2013 Category: Universities & Medical Training Authors: Richard Winters MD Tags: Uncategorized Source Type: blogs