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« on: June 16, 2013, 12:46:57 AM »

Vagus Nerve Stimulator by Cyberonics: A Telling Anecdote about Regulatory Capture and Medical Device Safety

Howard Brody
Hooked: Ethics, Medicine, and Pharma
Mon, 10 Sep 2012 13:12 CDT


Thanks to an exchange of e-mails on a list that includes journalists Jeanne Lenzer and Shannon Brownlee (whose great work I've previously blogged about), I was directed to an article (subscription required) that I failed to make note of when it came out nearly two years ago. It provides useful background to an issue that has become even more heated this last year, the medical device safety oversight problem (see for example here).

Lenzer and Brownlee looked in depth at the vagus nerve stimulator manufactured by Cyberonics, a device in which a pacemaker-type pack is surgically inserted near the collarbone, and electrodes are wrapped around the vagus nerve in the neck. The device was intended at first for a select population of patients with a particular type of epilepsy that's resistant to all drug treatment. Like many devices and drugs (and in keeping with the Inverse Benefit Law), once having gotten the camel's nose into the tent, Cyberonics is now claiming that the stimulator can be used for a large number of other conditions, notably depression, and perhaps obesity and traumatic brain injury (stay tuned for hair loss and bad breath). All such uses rely on the purported safety of the device, which is what Lenzer and Brownlee zeroed in on.

In 1997, Cyberonics went to the FDA to get initial approval of the stimulator for epilepsy. They presented three studies to document the device's effectiveness and safety. One review panelist noted that 17 of the 1000 subjects who'd had the device implanted had died, and asked what was up with that. The explanation offered by the company and other panelists is that people who have that sort of hard-to-treat epilepsy have a high death rate because periodically those seizures cause cardiac and respiratory arrest. So deaths were due to the disease and not the device.

The FDA bought this explanation but added a caveat--Cyberonics got approval conditionally upon conducting a post-marketing surveillance study to address the concern about possible excess deaths.This, as Lenzer and Browlnee explain, is not an unusual measure--the studies needed to lead to drug or device approval are often, of necessity, too small to detect rare but serious adverse effects, and only after a drug or device is more widely used may such effects become apparent.

But here's where the story gets interesting. Lenzer and Brownlee then went after the data accumulated by the company during this mandated post-marketing study phase. They found several very worrisome things. First, there were at least isolated reports of deaths or near-misses that seemed quite clearly to be due to the device. (One patient who survived was observed to have his heart stop at exactly the intervals at which the stimulator fired, and the heart stoppages ceased with the device was turned off.) When asked how many of these events had occurred, or how often, Cyberonics said they didn't know, because mortality statistics were not one of the planned endpoints in any of its trials. And despite the fact that the FDA had ordered these studies because of concerns about mortality, no one at the FDA seemed the least bit worried about the fact that Cyberonics had set up its studies deliberately to exclude mortality data.

For many years, British sociologist John Abraham has written about regulatory capture--what happens when a government agency that is supposed to regulate an industry ends up becoming so closely tied to industry that it becomes a tool rather than a watchdog. When the Institute of Medicine weighed in on how inadequate the current regulations are for monitoring device safety, one might have thought that the FDA would appreciate the help they were getting to call for more stringent regulations--but instead the FDA went out of its way to defend the current inadequate practices and to blast the IOM's conclusions. Since then, as per previous blog posts referred to above, the device industry has unleashed a lobbying armageddon on Congress, demanding less rather than more regulation of device safety lest a single good job in the US be sent overseas.

The combination of merciless lobbying plus FDA capture makes it highly unlikely that we'll see a day anytime soon when the US public can have much confidence that medical devices are adequately checked for safety. How it works out that there's a huge media outcry if a single person dies from E.coli in their lettuce, but dozens or hundreds can die due to malfunctioning medical devices without anyone losing any sleep, needs to be better explained.

Reference

Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ 341:966-68, 6 November 2010.



http://www.sott.net/article/251014-Vagus-Nerve-Stimulator-by-Cyberonics-A-Telling-Anecdote-about-Regulatory-Capture-and-Medical-Device-Safety
« Last Edit: October 20, 2013, 09:28:39 AM by Birdbomb » Logged
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« Reply #1 on: October 20, 2013, 09:31:52 AM »

Dear Mr. Brody

I was implanted with vns in Sept 2002 of epilepsy. Prior to that time, Cyberonic$ had their own message board for their patients (as we were called then) and I was an active member. Many people complained about side effects or lost loved ones and wanted answers, long story short, Cyberonic$ killed their message board out of fear.  One month later, my site was born. It speaks for the 10,000's who are injured, damaged or killed by this device.

For years I have tried to warn people to be careful, if it sounds to good to be true...  Cyberonic$ wined and dined the early patients like myself and broke down our defenses. They LIED bout side effects and manipulated the statics to make this thing look like a God-send. Cyberonic$ hired slick marketing companies to push vns into the mainstream. The laws were changed to protect medical device companies instead of patients so most of us have no recourse but to live with the damage the vns has caused or worse, to morn the loss of our loved ones killed by this hideous thing.

It sickens me to see them implanting this in babies or children but even worse, those individuals with no ability voice if they are in pain.  

My Moderator tracks every single entry made to the FDA's M.A.U.D.E  Reports.  First off let me say it is very difficult to even get a physician to make an adverse report much less file it. So not every incident is on file, my educated estimate is less than a 20% are reported. To date, over 1000 deaths involving Cyberonics' VNS Therapy have been reported. Now keep in mind this is NOT the actual number of reported deaths, the number will be higher than 4000, but here is a funny added bit of information.  On most of these deaths where there is no known reason, so Cyberonics makes the determination of death is due to SUDEP (Sudden Unexpected Death in Epilepsy)!! Really?! They can presume the cause of death of a body they have not even seen?  This is the way Cyberonic$ eliminates vns from the death.  My heart goes out to all those poor families!

FDA is a joke. Big pharma and medical device companies win.  Tell the people what they want to hear, make money hand over fist, pay paltry fines for the lies and deceit  but no matter, they got the money while we have broken promises and shattered lives.

I never knew so many people could suffer so much pain and live a life of quiet torture until I walked into the world of Cyberonic$. My friends have died, my health is in shambles all thanks to vns and the FDA.

Sincerely,
Donna Baum
Site Owner
http://www.vnsmessageboard.com
« Last Edit: October 20, 2013, 09:46:41 AM by Birdbomb » Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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