November 12th, 2011 by GarySchwitzer in Opinion
No Comments »
I have written many times on this blog about one shining example of the medical arms race – the slow (some would say not so slow), steady, proliferation of huge and hugely expensive proton beam radiation facilities in medical centers in the US. I have written about how the proliferation never seems to occur in single units – rarely just one per town – but almost always two simultaneously – the medical arms race among health care institutions and providers at play.
The latest chapter is playing out in San Diego, as captured by HealthLeaders Media Online senior editor Cheryl Clark.
Excerpts:
“As members of the debt reduction “super committee” wrestle to slice $400 billion from Medicare over 10 years, I wonder what they might say about the $430 million proton beam center war now being waged a few miles from my home in San Diego.
This nearly half a billion dollar investment in proton therapy is a big part of Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
October 30th, 2011 by GarySchwitzer in News, Research
No Comments »
Reporter John Fauber has published the latest in his “Side Effects” watchdog series, headlined “Doctors didn’t disclose spine product cancer risk in journal: Spine-product paper omitted key data.” Excerpts:
“Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company’s spine surgery product in a 2009 paper about results of a large clinical trial.
The surgeons left out important data and claimed there was no significant link between the product and cancer.
The company and doctors had become aware of information on Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
September 15th, 2011 by AndrewSchorr in News, Opinion
No Comments »
I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.
But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »
*This blog post was originally published at Andrew's Blog*
August 20th, 2011 by DeborahSchwarzRPA in News
No Comments »
As of May 2011, performance of MitraClip, a minimally invasive procedure to correct mitral regurgitation, has been voluntarily suspended due to a problem with its catheter delivery system.
Since 2008, about 3000 patients with severe mitral valve regurgitation (leaky mitral valve) have been treated with MitraClip rather than open surgery. In this minimally invasive procedure a small clip is delivered via catheter to the heart, where it is carefully placed over the center of the mitral valve. This non-surgical option has been an important alternative for patients who may be unable to withstand open surgery. MitraClip has been advanced and investigated at NewYork-Presbyterian/Columbia since the first EVEREST trial in 2004, and is currently available throughout the U.S. as part of the EVEREST II trial. Read more »
*This blog post was originally published at Columbia University Department of Surgery Blog*
August 18th, 2011 by DrWes in Opinion
No Comments »
With the explosion of medical devices to treat various medical ailments in medicine, we have seen significant improvements in quality and quantity of life. An underappreciated consequence of all of these electronic device therapies, however, has been the manpower and expertise required to manage these implanted electronic medical devices long-term.
Problems with electromagnetic interference (EMI) with medical devices are real. Innovations in medicine have come from various portions of the electromagnetic spectrum including analog and digital wireless technology, diagnostic and therapeutic radiation therapy and magnetic resonance imaging. The effects of these technologies on implanted electronic medical devices can vary and specialty physicians, ancillary health care providers, and medical device manufacturers expend significant man-hours managing these potential interference sources and their affects on devices without a single prospective randomized trial to guide us. The sheer number of devices and the many ways that EMI can interfere with these complex devices makes constructing an all-inclusive trial with sufficient number of “events” to compare difficult or nearly impossible. As a result, most of our management recommendations and hospital policies in this regard have been based from literature case reports or personal experience and expertise.
To date, recommendations for minimizing EMI with cardiac implantable electronic devices has Read more »
*This blog post was originally published at Dr. Wes*
