There’s a new program at the US Food and Drug Administration. One designed to afford innovative devices a speedier review process. This Innovation Pathway 2.0 program is designed for pre-market evaluations of medical devices, expediting the process without reducing the need or quality of safety and effectiveness reviews. And some 30 years ago, there was a similar process for smaller companies- it worked, then, too. (I know, we used it- twice!)
Category Archives: Dialysis
Silent Killer
One of the biggest components of the US Healthcare costs is kidney failure. About 1/9 of Americans (26 million) suffer from chronic kidney disease. $ 40 billion a year in costs. Almost 400,000 of Americans undergo dialysis thrice weekly.
AWAK. What’s that? A VA hope for the future…
The Veterans Administration is trying hard to fulfill its mission of caring for vets. Given the last 10 years of war, with its high casualty rate for both troops and reserves, this mission is going to be more difficult in the future. One of the ways the VA hopes to deal with these newer problems is to seek out new ideas. The VA Innovation Initiative (VAi2) is one such concept, where employees, private sector firms, entrepreneurs, and academicians are invited to submit innovations that will help augment access to VA services, or improve the services offered themselves.
Continue reading AWAK. What’s that? A VA hope for the future…
1, 2, 3, 4, 5, 6, 7… Seven Links
THIS POST HAS MANY LINKS. AND, I AM NOT WORRIED ABOUT PEOPLE STEALING THIS INTELLECTUAL PROPERTY. SO, IF YOU WANT TO BE ABLE TO RIGHT CLICK ON A LINK TO OPEN IT IN A NEW WINDOW OR A NEW TAB, FEEL FREE TO READ THIS POST HERE.
Kidneys. Stem Cells. Breakthroughs.
Big changes afoot (pun intended) for blood clot control…
For 57 years, patients have been receiving Coumadin to reduce the risk of blood clots. What most of them don’t know is that their “drug” really rat poison- warfarin. That is not really the problem (other than the “yech” factor)- it’s that the effective dosage is difficult to ascertain and maintain. Too low a dose- and the potential for bleeding out exists; too much warfarin- and the patient’s blood congeals, precluding blood flow. Certain foods (broccoli, spinach, among other Vitamin K laden vegetables) interact with the drug, and each patient has a different response to warfarin; women with menstrual cycles, obviously, have a more difficult time maintaining the optimal dosage. Basically, the only way to determine the effective dosage is to monitor the blood clotting time (which is not performed daily or weekly)- it’s “hit or miss”.
Continue reading Big changes afoot (pun intended) for blood clot control…
Dialysis is BIG business. It’s going to get BIGGER still!
Some days I just can’t believe it. More than ½ a million Americans have kidney failure; about 350,000 are on dialysis. These are so much higher than the numbers we expected way back in the early 70’s. While most of the patients are covered by Medicaid and Medicare (the latter now covers everyone after 14 months or so), most of the “gravy” comes from private pays- the first 14 months of treatment and those covered by private insurance. The dialysis companies also had erythropoietin (EPO) dosages to provide additional cash, but the Federal government has cut back the approved dosages (no EPO if the hemoglobin levels are 12-14 g/dL) and begun using bundled payments to keep the reimbursements lower. (By the way, a Veterans Administration/Harvard School of Public Health study recently showed that a change in dose of EPO from 15000 to 45000 units/week harmed diabetic kidney patients [from 20 to 33 % greater death risk, respectively, plus additional cardiovascular problems], in particular.)
Continue reading Dialysis is BIG business. It’s going to get BIGGER still!
Hope for Kidney Patients?
We have a tremendous problem here in America (and the world). We are becoming fat and lazy. Invariably, that means diabetes is on the rise. Inevitably, that means kidney failure is imminent. (And, some of us are already on that fast track, just because of our genes!). I know we all need to lose weight (is this the pot calling the kettles black, or what?). But, isn’t there something else that can be done, too? (I don’t mean to develop another dialyzer; a stem-cell kidney replacement would be nice. But, I am hoping for a preventive measure, and…)
A Bioartificial Kidney is Introduced
We expect scientists and engineers to provide us with the truth. And, generally, they do. And, there are times when scientists and engineers are allowed to dream and tell us their dreams. The problem is when folks take those talks out of context and confuse the general public.
Remember those “death panels”?
There was a great deal of controversy two years ago about the supposed imposition of “death panels” in Obama’s health care plan. Yet, there seems to be no controversy whatsoever about the “death panels” that are implicit in the more than 10 states’ plans to slash Medicaid funding in their states. Dealing with (real and purported) budget shortfalls, these states are slashing their budgets for Medicaid. The end result is that indigent and lower middle class patients will simply be told that there is no money for their care or for care for their children.