THE SECRETS HIDDEN FROM YOUR DOCTOR WHICH COULD KILL YOU
On March 11th, Huffington Post published a report by Kaiser Health News stating thatThe FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.
Read the full report here:
Instead of issuing a full report on each malfunction or injury, a device manufacturer is given an "exemption" which allows it to update a spreadsheet of such incidents, so it looks like there is only one report when investigating the spreadsheet could reveal many such problems. And this spreadsheet is in a database so secret that many in the FDA have never heard of it.
And for those who find out about its existence the FDA has made access to this secret database all but impossible. Using the Freedom of information Act might make them let you look, but it could take up to two years for that to happen.
All of which means that if your doctor wants to use a medical device with the best safety record, or a medical research engineer wants to avoid design problems that have cropped up in the past, they're in trouble -- and so are you. KHN concludes this explosive article with the following:
The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients. “It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”
In other words, the FDA -- like the government of which it is a part -- is more interested in the health of business than it is in the health of people.
This is why a mere nibbling around the edge of current policy ultimately will not change a thing. We need nothing less than a great sea-change in this country, so that in matters of healthcare, profits will no longer have primacy -- patients will. And that will not happen unless we all raise our voices.
Have you been silent about healthcare reform? That means you have acquiesced to the current dysfunction, and if you acquiesce to it, you enable it.
Dio
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PPS: We know that there are plenty out there who have stories to tell -- stories of your trying to cope with our dysfunctional healthcare system. Trouble is, we don't know what these stories are! That's where you come in. If you have a story to tell, you can email me at indivisible12401@gmail.com. You can be as anonymous as you like. Thanks!
PPS: We know that there are plenty out there who have stories to tell -- stories of your trying to cope with our dysfunctional healthcare system. Trouble is, we don't know what these stories are! That's where you come in. If you have a story to tell, you can email me at indivisible12401@gmail.com. You can be as anonymous as you like. Thanks!
