WSJ By Joseph Walker - Nov. 16, 2013 2:27 p.m. ET | Regulators have determined that defects in some medical devices made by Medtronic Inc. have the potential to cause serious harm or death, according to statements issued by the company and the U.S. Food and Drug Administration Friday night. The FDA’s determination relates to a recall initiated by Medtronic last month of nearly 15,000 guidewires manufactured since April that are used in heart procedures. The FDA has now designated the action as a Class I recall, the most serious classification given to product recalls. Read more
Transparency, Not Marketing
NY Times | November 17, 2013, Rosemary Gibson - Americans have just learned that they need to divorce themselves from a drug-prescribing regimen that has been marketed for decades to supposedly mend broken hearts. We’re now told that the evidence never existed for lowering cholesterol levels to numerical targets by taking statins and other drugs. Curious minds will ask why a multibillion-dollar medical practice that lacked scientific basis was permitted and paid to subject a large swath of people to a human experiment. Big money means you never have to say you’re sorry. Read more
J.&J. to Pay $2.2 Billion in Risperdal Settlement
New York Times By KATIE THOMAS November 4, 2013 | Johnson & Johnson has agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly promoted the antipsychotic drug Risperdal to older adults, children and people with developmental disabilities, the Justice Department said on Monday. The agreement is the third-largest pharmaceutical settlement in United States history and the largest in a string of recent cases involving the marketing of antipsychotic and anti-seizure drugs to older dementia patients. Read more
Posted in Headline of the Day
Tagged Bad Pharma, big pharma, Janssen Pharmaceuticals, pharmaceutical fraud
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Pronovost Lauds Patient Reporting of Adverse Events via FDA Site
Cheryl Clark, for HealthLeaders Media, October 24, 2013 | The FDA apparently isn’t satisfied that doctors and hospitals are reporting all they know about drug errors and harm from medical devices. A top physician and safety advocate says enabling patients to report events is a welcome “paradigm shift.” When patient safety rock star Peter Pronovost, MD, learned that the U.S. Food and Drug Administration is now urging patients to report drug and medical device adverse events directly to the agency, bypassing hospitals and doctors, he got so excited he rushed to create a podcast. Read more
In The Race For ‘Fanciest Hospital In Town,’ Patient Safety Loses Out
by Ashish Jha Hospital, or Hilton? Ashish Jha says too often patient safety takes a backseat to marketing efforts. In this photo, the main atrium of the Henry Ford West Bloomfield Hospital is seen in West Bloomfield Township, Mich., Wednesday, Feb. 25, 2009. The $360 million, 300-bed hospital features a bevy of perks for patients, including private bedrooms with wireless Internet access and feng shui designs; tasty cuisine cooked up by a high-profile local chef and a main street of small specialty retail shops. (Carlos Osorio/AP)
Did you hear about the hospital that spent $100 million to eliminate medical errors? Or the large healthcare system that guaranteed patient safety, fully compensating any patient who was harmed? You might have missed these stories because, as far as I know, they didn’t happen. But as hypothetical scenarios they make an interesting contrast to two recent real news stories. Read more
Posted in Headline of the Day
Tagged Hospital Medical Errors, Medical Error, patient sa
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Brand-name Drug Choices Drive State’s High Medicare Costs
C-Hit.org By: Lisa Chedekel | Connecticut seniors on Medicare are more likely to take sedatives for insomnia and medications for depression than their counterparts across the country, according to a new report by Dartmouth researchers. An analysis of state data in a national report by the Dartmouth Atlas Project also shows that Connecticut’s Medicare program relies heavily on brand-name drugs, versus generics, especially in wealthy towns in Fairfield County – a factor that could be contributing to the state’s ranking in the top 10 nationally in prescription drug spending per patient. Read more
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Tagged Dartmouth Atlas Project, drugs, Medicare, prescriptions
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Robot Surgery Damaging Patients Rises With Marketing
Bloomberg.com By Robert Langreth Oct 8, 2013 12:00 AM ET Porter Adventist Hospital in Denver announced last year that Warren Kortz, a general surgeon on the medical staff, was the first in the Rocky Mountain region to use a technique known as robotic surgery to remove gall bladders through one incision in the belly button. Robot-assisted surgery differs from other minimally-invasive operations in which doctors stand over the patient and manually manipulate instruments and a tiny camera through multiple small incisions. The operation, performed while the doctor sits at a video-game-like console, was “taking advantage of another breakthrough in robotic surgery” and is “easier on the patient,” the hospital said in a press release. “It’s Star Wars stuff,” Kortz was quoted as saying in another article put out by the hospital touting another operation, robot-assisted parathyroid surgery, in 2010. “My prediction is it will eventually replace everything else.” What the hospital and Kortz didn’t reveal was the risk. Even as Kortz promoted robotic surgery, 10 patients he treated suffered injuries or complications between 2008 and 2011, according to an April complaint by the Colorado Medical Board. Read more
Count the Dead From Medical Harm
HuffingtonPost.com October 8, 2013 by Rosemary Gibson | The military counts its dead and wounded even though politicians would prefer to hide the truth. Public health officials count the deceased and injured from drunk driving. The alcohol industry might prefer to hide the mayhem by slashing public health funding, but wiser, compassionate minds prevail. Counting the dead is a way that society says a life matters. It honors the deceased, a mother, father, sister or brother, son or daughter. Failing to count them is to dishonor them. In hospitals, nursing homes and other health care facilities, no one counts those who die or are injured because of preventable mistakes and infections. Read more
Reducing medical errors will require better reporting tools, engaged patients and – you guessed it – culture change
MedCityNews.com September 27, 2013 8:30 am by Deanna Pogorelc - “Culture change.” Those words just keep coming up again and again in talk about what’s needed to reduce healthcare costs, to make better use of health information technology, and in this case to stop preventable medical errors that harm patients. Patient Safety America founder John James recently published a study in the Journal of Patient Safety that estimated the annual number of medical errors in U.S. at up to four times the number the Institute of Medicine estimated in 1999. He joined other experts representing vendors, providers and pharmacists on Thursday for a TEDMED Great Challenges Google+ hangout focused on eliminating medial errors. Read more
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