To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”
- David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA’s Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.
To win an expensive technology on behalf of patients these days, there will have to be “harmony” between doctors and their professional organizations and government regulators. If not, patients lose.
At issue is a transformative technology – another milestone forwarding medical innovation on behalf of some of our oldest and sickest patients: those with critical aortic stenosis who are too sick to undergo open heart surgery. Aortic stenosis tends to be a disease of the elderly that carries at least a 2-year 50% mortality when accompanied by a weakened heart muscle. Yet thanks to the wonders of careful engineering and some daring researchers that paired their expertise and lessons learned from a variety of disciples (cardiothoracic and peripheral vascular surgery, cardiology, and even cardiac electrophysiology), technigues and technology have combined to offer a percutaneous option for aortic valve replacement.
Everyone involved in this research (and even those who have watched from afar) knows this therapy works. Most believe in the long run, it will prove to be a safer option than open heart surgery in these patients.
But that’s about where the harmony ends. Read more »
*This blog post was originally published at Dr. Wes*
The old joke in medicine goes, ‘don’t get sick on July 1st.’ That’s because it’s the day when new resident physicians, freshly graduated from medical schools across the land, begin their training programs. Although they have spent four years in undergraduate school and four years in medical school, it’s residency where physicians are made from the raw material of knowledge-rich, experience poor high achievers.
However, even in residency physicians are seldom told the entire story of how the practice of medicine, and their lives, will look and feel as their careers evolve and they enter the medical work-force.
Since our profession changes from year to year and administration to administration, it seems a good time to mention some of the things upcoming young physicians will face. Sadly, these are things seldom mentioned by pre-med advisors or academic medical educators.
You see, physicians are struggling. Due to falling reimbursements and the ongoing federal mandate to see non-paying patients on call, it is increasingly difficult for physicians to cover costs like malpractice insurance, licensure, professional memberships and office overhead. (Well, if they want to have a house, family and food, that is.)
Many physicians are Read more »
*This blog post was originally published at edwinleap.com*
The New York Times says “In Medicine, New Isn’t Always Improved.”
Who can argue with this?
“In Dining, New Restaurants Aren’t Always Better.”
Yes, that’s true, too. But does it mean anything?
The article is about a type of hip that is apparently going to be the focus of a lawsuit. The story goes that a lot of people wanted the new hip when it came out, because it was thought to be better than the older ones. Unfortunately, the hip seems to have hurt some people, some of whom may have been better off getting the older one in the first place.
A doctor quoted in the article suggests it’s part of a uniquely American tic. We want all of the latest and greatest things for ourselves, it seems. This story is supposed to be a cautionary tale of what can go wrong when we do.
On the other hand, the latest and greatest things don’t appear out of nowhere. In America, when people demand something, there will be someone who supplies it. Read more »
*This blog post was originally published at See First Blog*