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Is the FDA One of the USA's Biggest Killers?

By   Follow Me on Twitter     Message Rob Kall       (Page 1 of 1 pages)     Permalink    (# of views)   21 comments

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FDA policies may be responsible for over 80,000 deaths caused by inadequately or completely untested medical devices.

There are over 32 million Americans with implanted devices in their bodies-- about ten percent of Americans. That's mind-boggling. But more so is the fact, reported by an article in the Washington Post, The FDA is still letting doctors implant untested devices into our bodies. The ICIJ--International Consortium of Investigative Journalists--reports that "FDA data reveals more than 80,000 deaths and 1.7 million injuries possibly linked to medical devices in the past decade." And hundreds of thousands of patients with implants have had to deal with device recalls, often requiring removal of a device.

While the FDA is claiming to be planning to make "transformative" changes in their regulations, the reality is that there are huge loopholes that, for decades, have allowed manufacturers to evade real clinical trial testing. The problem is, the FDA identifies the device manufacturers as its customer base. That reflects the pathological neoliberal capitalism over a people-supporting-commons nature of politics today. The WaPo article advocates for the re-opening of the Office of Technology Assessment, which, the Post observes, "the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich's Contract With America."

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The problem is, in recent decades, presidents have appointed FDA heads who are loaded with conflicts of interest, coming from the industries they are supposed to regulate. The WaPo argues that the head of the FDA should be a civil servant, not a political appointee. Of course that takes away power from the president who appoints and the congress that authorizes. So the FDA problem is really a symptom of power-grabbing gone wild. And what legislator running for office would campaign on wanting to give away power? It's a conundrum.

The ICIJ article reports that it's even worse in other countries, where they "place their trust in U.S. and European authorities." That mirrors my experience. Twenty-five years ago I met, in Moscow, with the head of the Russian counterpart to the the USA's National Institute of Health. Shortly after, I received a call from someone at the FDA, asking me to advocate to him for adoption of the FDA's policies on drugs and devices. The FDA was actively evangelizing its policies to the rest of the world. I saw it as an extension of the marketing arm of Big Pharma and the device manufacturers.

The idea of anti-regulation and deregulation is a core value of conservatism. The policy, which is, in my mind, a core reason tens of thousands of people are dying because of inadequately tested medical devices, is a part of the malignant form of predatory, psychopathic capitalism that both political parties in the USA have allowed to become dominant.

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It is certainly possible for the existence of a regulation-embracing capitalism couched in the wisdom of bio-mimicry and an understanding of how nature sustainably functions. This is a bottom-up, connection-conscious way of seeing the bigger picture, which includes the effects of products on people's health. It is insane that the FDA has failed to identify the U.S. health consumer as its customer. And it is outrageous that congress and decades of recent presidents have enabled, even encouraged, this to happen. Worse, it is clear that deregulation of protections is happening in virtually every federal agency with mandates to protect the public, workers and the environment.

Adding insult to injury, we have this added reason to be concerned. The FDA has been hit by Trump's refusal to approve government funding. This is the message the Trump administration has authorized, that's on the FDA website:

FDA Lapse in Funding

In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds. Read more

 

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Rob Kall is an award winning journalist, inventor, software architect, connector and visionary. His work and his writing have been featured in the New York Times, the Wall Street Journal, CNN, ABC, the HuffingtonPost, Success, Discover and other media. He's given talks and workshops to Fortune 500 execs and national medical and psychological organizations, and pioneered first-of-their-kind conferences in Positive Psychology, Brain Science and Story. He hosts some of the world's smartest, most interesting and powerful people on his Bottom Up Radio Show, and founded and publishes one of the top Google- ranked progressive news and opinion sites, OpEdNews.com

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Rob Kall has spent his adult life as an awakener and empowerer-- first in the field of biofeedback, inventing products, developing software and a music recording label, MuPsych, within the company he founded in 1978-- Futurehealth, and founding, organizing and running 3 conferences: Winter Brain, on Neurofeedback and consciousness, Optimal Functioning and Positive Psychology (a pioneer in the field of Positive Psychology, first presenting workshops on it in 1985) and Storycon Summit Meeting on the Art Science and Application of Story-- each the first of their kind.  Then, when he found the process of raising people's consciousness and empowering them to take more control of their lives  one person at a time was too slow, he founded Opednews.com-- which has been the top search result on Google for the terms liberal news and progressive opinion for several years. Rob began his Bottom-up Radio show, broadcast on WNJC 1360 AM to Metro Philly, also available on iTunes, covering the transition of our culture, business and world from predominantly Top-down (hierarchical, centralized, authoritarian, patriarchal, big)  to bottom-up (egalitarian, local, interdependent, grassroots, archetypal feminine and small.) Recent long-term projects include a book, Bottom-up-- The Connection Revolution, debillionairizing the planet and the Psychopathy Defense and Optimization Project. 

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12 people are discussing this page, with 21 comments


Stephen Fox

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So glad you pulled this together, Rob.


Sadly, it is a much much worse problem than the realms of omission which you describe.


I believe for the past 50 years, American food and drug corporations have had a beyond-cozy beyond-revolving-door relationship with the FDA, allowing all sorts of horrible chemicals to be added to food.


Just read the ingredients on almost any packaged food, with chemicals you have never heard of, food additives, carcinogenic colorings that are "generally recognized as safe."


Start the list with aspartame, the neurotoxic carcinogenic artificial sweetener that is metabolized as formaldehyde. That one alone has killed MILLIONS of Americans, not just tens of thousands.


Add the hundreds of millions worldwide, and just this one chemical alone paints a very ugly picture of the failings of the FDA.


Although this video is mostly about drug prices, not overall quality, it shows what kind of FDA Bernie would create.




Bernie Sanders DESTROYS Trump's Big Pharma LIES AND HYPOCRISY While Grilling FDA Nominee Bernie Sanders exposes and destroys Donald Trump's lies and hypocrisy on big pharma, while skillfully dismantling Dr. Scott Gottlieb, Trump's nominee for head ...
(Image by YouTube, Channel: Dose of Dissonance)
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Submitted on Sunday, Jan 6, 2019 at 5:38:45 PM

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lila york

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bottom line - the US no longer has a government at all.It is a corporate theft freeforall. If you want to live in a civilized society, move to some other country. one that still has a government..

Submitted on Sunday, Jan 6, 2019 at 6:27:33 PM

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Yeah, but where?

Submitted on Sunday, Jan 6, 2019 at 9:31:54 PM

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How 'bout Bhutan, Buddy?

Submitted on Monday, Jan 7, 2019 at 12:11:42 AM

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Sorry but for the testing to prove that everything is "safe beyond reasonable doubt" many would not get something that is clearly helping them.

"80,000 deaths and 1.7 million injuries possibly linked to medical devices in the past decade"

Key is "possibly". It is neither proven nor based on firm evidence.

Right now it is muchj more serious that many Americans don't get good medications because they could not complete "satisfactory" (for the purists) testing.

And who to test them on?

God forbid, chimpanzees?

Submitted on Sunday, Jan 6, 2019 at 9:15:56 PM

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Well said.

Submitted on Monday, Jan 7, 2019 at 1:26:55 AM

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What immediately came to mind when I read this is the Thalidomide scare. I can't recall exactly when that was anymore but what happened is that it was prescribed for pregnant women apparently without being tested on any pregnant women and the results were a lot of babies born with missing limbs. The FDA took so much heat over this that they increased the drug testing requirements to such an extent that it has become impossible for Americans to get drugs that have been safely used in Europe for years.

I don't recall the numbers anymore but subsequent studies estimated that far more people have died from lack of access to those drugs than were affected by any approved drugs which were later found to have bad side effects.

Doctors should not be able to prescribe anything without full disclosure about its status and known side effects. But neither should the government be able to prevent anyone from getting access to drugs or medical devices that both the patient and their doctor believe would be beneficial.

Submitted on Sunday, Jan 6, 2019 at 10:02:05 PM

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I guess the question there is, are patients or even their doctors getting the reliable information needed to make these decisions? The way I see it, doctors are being sold a bill of goods, which they then promote to their patients. If that bill of goods is sold with fraudulent or omitted information, then there's an obvious problem.

Submitted on Sunday, Jan 6, 2019 at 10:35:48 PM

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I'm a pharmacist, now 90, get most of my meds from the V.A. at greater costs than

at a local drugstore sometimes but one should see the paperwork on directions, warning and sideeffects even though the drug could be incompletely tested by the

producer and made available for prescribing.

Submitted on Monday, Jan 7, 2019 at 12:22:16 AM

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As a nurse, I am very aware that pharmaceutical reps visit offices with a plateful of cookies and an announcement of their 'latest and greatest' new drug for whatever condition. The doctors are then given samples. Often 'name-brand' drugs (expensive) have generic alternatives (much cheaper). I believe the name-brand ones are used for a while before they are can be available in generic form.

Submitted on Monday, Jan 7, 2019 at 3:06:58 PM

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Yes, and with the plate of cookies and samples, comes what is supposed to be documentation printed by their own people. In my eyes, these companies should not be allowed to promote their goods directly to the doctors. There's no oversight of this process. We don't know what is being presented there, and I'm sure the negative concerns are downplayed, in order to get a more positive promotion.

I always say, doctors are only as good as the information they get. One good illustration of this is seen in the way they're currently treating my mother in the hospital for a broken femur...

She's 83, and has Progressive MS, which has cut her mobility down to about 25% at this point. Anybody who knows anything about MS knows there is serious problem with the immune system betraying the nervous system. Drugs usually backfire on the patient, for just that reason. But still, we've had to fight with 4 doctors to get them to stop trying to force neuropathic drugs on her! Neuropathic drugs work on the very principle that MS is working against.

These doctors insist on using such drugs, based on the "documentation" given to them. If there's no indication of a conflict, the doctor often doesn't see one either.

Submitted on Monday, Jan 7, 2019 at 6:04:34 PM

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Good Afternoon, DA -Hear you loud and clear. I've been living with peripheral

neuropathy for a while and have been trying a plan to live with it until the VA, unable

to do much, said it could be a cervical nerve suffering from vertebral arthritis, and

had me check with an EMG (electro -myo-gram) out of the system. The guy who

could perform it set up the test with electric prods similar to an electric fence for bison range, quickly told me, too, I was suffering from a form of carpal tunnel

syndrome caused by previously broken ulnar-radial wrist bones. At least no new

chemical drug treatments. Maybe next they'll check my prostate or caudal

appendage.

I don't take medications. Quit pharmacy when BigPharma took over.

Submitted on Monday, Jan 7, 2019 at 7:05:59 PM

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If your doctor is ignorant or fraudulent find a better one.

That is the only way.

Submitted on Wednesday, Jan 16, 2019 at 1:05:28 AM

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Except that if the products-- remember, this article is about medical devices-- are not tested at all, there is not information to share. Yeah, sure it would be nice if no regulations were necessary. But tests save lives. And I don't buy that not having untested drugs available costs lives.

Submitted on Monday, Jan 7, 2019 at 5:26:35 AM

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"I don't buy that not having untested drugs available costs lives."


It's interesting that you used the number 80,000 in your first paragraph.


That's how many people died of preventable second heart attacks in the three years the FDA dragged its heels on approving propranolol, the first beta-blocker.


And that's just one drug.


How many people died of preventable bleeding from traumatic injury in the THIRTY FOUR YEARS FDA took to approve cyanoacrylate?

Submitted on Monday, Jan 7, 2019 at 2:36:25 PM

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If the the device has not been tested than that is the information that the doctor should have to share. I find it unlikely that a doctor would recommend such an option unless the patient was at death's door and this was their only option for possible survival. And any patient who would let a doctor implant such a device except as a desperate last chance is showing extremely poor judgement. Never the less, it should still be their choice.

Submitted on Monday, Jan 7, 2019 at 4:41:19 PM

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Who do you test medical device on?

Submitted on Wednesday, Jan 16, 2019 at 1:03:25 AM

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I think it's safe to say that the system of private profit over the public good has been a growing problem since the invention of capitalism. The end result is the global catastrophe we have today.


We need a global yellow vest solidarity movement. Sooner rather than later.

Submitted on Monday, Jan 7, 2019 at 12:26:05 AM

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So devices implanted without FDA approval may be responsible for a tiny fraction of the number of deaths for which the FDA bears responsibility due to its foot-dragging on drug approvals? Interesting!

Submitted on Monday, Jan 7, 2019 at 2:14:18 PM

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Thanks for the excellent reference, Thomas. It had all those important details that have escaped me over the years. Everyone here who commented in favor of the FDA needs to read it.

Submitted on Monday, Jan 7, 2019 at 4:51:26 PM

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It's an incentive problem that, more than most, clearly implies a profit motive solution.


If someone dies from a drug or device that the FDA has approved, the FDA gets blamed ... but doesn't pay. In fact, it probably gets a bigger budget to be more careful. If someone dies from a drug or device that the FDA hasn't approved, the FDA doesn't get blamed, and gets more money for enforcement. There's just not a lot of incentive for the FDA to be efficient about this kind of stuff.


Who has a profit interest in approving safe/effective drugs and not approving unsafe/ineffetive drugs?


INSURERS.


If you read your homeowner's insurance policy closely, you'll likely find an exclusion for fire damage caused by malfunctioning devices that are not approved by UL (formerly Underwriters Laboratory). UL was formed by insurers for the express purpose of testing devices so that those insurers wouldn't be paying out so much money for fires caused by electrical short circuits, doors that burst into flame instead of helping contain a fire in a room, etc.


Health insurance companies have an obvious interest in quickly getting the best treatments to patients most cheaply to reduce their own costs vs. profits. Life insurance companies have an obvious interest in not paying out death penalties earlier instead of later because bad drugs got prescribed.


If UL was expanded to do the FDA's job, it would not just save taxpayers money, it would save those taxpayers' lives.

Submitted on Monday, Jan 7, 2019 at 5:21:11 PM

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