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
PS: If you'd like to leave a comment -- and I encourage you to do so -- simply click on the "number of comments" area, and share your thoughts in the "comment rectangle" that appears.
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!
The problem of lack of regulation of medical devices was addressed at length by Jeanne Lenzer in her book "The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It (2017)." Jeanne is a journalist and physician's assistant. She is Kingston resident who also participated as a speaker at our meeting last April at the UU. She is a passionate advocate of universal health care (though a supporter of single payer, her experience leads her to advocate for a UK-like National Health Service system).
ReplyDeleteIn the right setting, having doctors on salary -- as in the UK -- is a good thing. Trouble is that in the US, proposing that as part of Single Payer might be a bridge too far in our current cultural climate. Some institutions -- like the Mayo clinic -- do very well with it, but to require it of everyone might make the screams of "Socialism!" deafening.
ReplyDeletehttps://uhfnyc.org/news/article/err-human-documentary-spotlights-toll-medical-errors/
ReplyDeleteNov. 26, 2018
"To Err is Human: Documentary Spotlights the Toll of Medical Errors"
UHF co-sponsored a screening of the documentary To Err is Human, which spotlights the crisis of medical errors.
A powerful REALITY:
Every year in the United States, some 440,000 people die from medical mistakes. Preventable medical errors are, in fact, the nation’s third leading cause of death after heart disease and cancer.
The panel took a deep dive into the issues that can lead to medical errors and efforts to improve safety throughout the health care system. “The harder you look, the more you find,”
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ReplyDeletehttps://thehealthcareblog.com/blog/2019/03/19/when-health-care-organizations-are-fundamentally-dishonest/
When Health Care Organizations Are Fundamentally Dishonest
Mar 19, 2019
March 19th, Brian Klepper
Mar 19, 2019
A class action legal ruling this month found that United Behavioral Health, UnitedHealthCare’s mental health subsidiary, established internal policies that discriminated against patients with behavioral health or substance abuse conditions
"A class action legal ruling this month, on a case originally filed in 2014, found that UnitedHealthCare’s (UHC) mental health subsidiary, United Behavioral Health (UBH), established internal policies that discriminated against patients with behavioral health or substance abuse conditions."
"It is important to be clear about what transpired here. Based on evidence, a subsidiary of UnitedHealthCare, America’s second-largest health care firm, has been found in a court of law to have intentionally denied the coverage of thousands of patients filing claims. The organization justified the restrictions in coverage using internal guidelines tilted to favor financial performance rather than accepted standards of care. In other words, UBH’s leaders (as well as those at UHC) knowingly defrauded their customers and devised a mechanism to rationalize their scheme. In his ruling, Judge Spero described testimony by UHC representatives as “evasive — and even deceptive.:
"The truth is that US health care is awash in excess, so much so that, to maintain the financial performance they’ve become accustomed to (and that the market has come to expect), many or most health care organizations now depend on egregious unit pricing and unnecessary services."
"Worse, US health care organizations typically turn a blind eye to these excesses."
"America cannot move toward a better health system until it stops tolerating health care practices that are fundamentally dishonest, not founded in evidence, and against the interests of patients and purchasers"
Brian Klepper is Executive Vice President of the Validation Institute and a health care analyst.
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