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Birdbomb
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« on: May 04, 2007, 11:45:03 AM »

http://www.cms.hhs.gov/MCD/viewdecisionmemo.asp?id=195

CMS has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we are issuing the following national coverage determination:

Vagus nerve stimulation is not covered for treatment resistant depression.
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labrat
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« Reply #1 on: May 05, 2007, 07:41:13 AM »

I wish they could have followed me for the last 11 1/2 years. Obviously they have no idea what TRD stands for which is a simply existing hell.


Labrat  :So Sad:     :im_033:  
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Birdbomb
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« Reply #2 on: May 05, 2007, 10:57:45 AM »

Please take the time to read their determination letter.  It is not too technical but very dry.  You will need to take several breaks.

They will not approve for depression in part because there is no set standard for determining depression.

The major reasons for the denial was Cyberonics own studies!  All 4 had different, criteria, different out comes and none were consistant.  The  concern was the implied placabo rate and VNS rate of effectiveness weren't that much different.

I am tryng not to simplify their decision, but it does have basis.

Now I know VNS works for you, Labrat.  And they read all those letters and commented on many of them, including the bogus and puffery statements often touted.

Those with TRD will have to find another avenue for payment other than CMS.




 
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VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #3 on: May 06, 2007, 08:35:35 PM »

Can I ask you, Birdbomb?

Do you even think this thing works?  Or do you think this is a very expensive excuse for a scar?
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Birdbomb
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« Reply #4 on: May 07, 2007, 05:59:59 AM »

Quote
Can I ask you, Birdbomb?

Do you even think this thing works? Or do you think this is a very expensive excuse for a scar?

second gen,

You are not the first person to ask me this.  But I can only give you an ambigious answer.

Yes for some, no for most

Until it's understood HOW and WHY it works, a higher success rate most likely won't be fesable.  Once that mechanisim is understood, the proper screening can be done and implanted in those who will most likely benifit.  Right now it's all a crap shoot.  Can't say who it works for, can't say how much relief the get and can't say for how long the treatment will last.  

This is an "ALPHA" product.  The first of it's kind.  It's going to have all kinds of quirks and problems because there is nothing else to compare it to, yet.  Even though the baisc technology has been around since the 90's and they have "years" in terms of studies, it still quite new.  

I am contacted by people all over the world with questions about VNS, with emails and phone calls wanting to know the same thing Does it work?   If you have been reading the forums, you will see it does work for a select group.  But for the majority, it does not.  And I think there are a few specific reasons, one being correctly diagnosed.  Epilepsy and depression are sometines very difficult to diagnose.

My seizure disorder began suddenly with one colossal gran mal that left me with a brain injury.  I never had another grand mal but many many simple particals and complex particals, plus was medicated to the eyeballs.  The medicaltion used to stop grand mals, often causes other types of seizure activity.  

A year later I was wined and dined by CYBX as the perfect candidiate.  Sudden onset, newly diagnosed.  But I did not jump right in, I researched anything and everthing I could find.  Back in 2001, there wasn't much and only 10,000 were implanted then, not a lot when you consider there are over 2.5 million in the USA alone with epilepsy.  It took me 6 months or more to make my ecision.

Depression has many faces and many diagnoses as well.  It all depends on the doctor and what guideline he/she uses to assess the type of depression.  There are no industry standards for these assessment such as there are for disorders and diseases like...diabities type I, juvenial onset, type II, adult onset, or hepititis I,II,III  

Every person I have know personally who has had the VNS implanted, the devise no longer is effective.  Some had a year or 2 of  some relief, most had little or none.  And the majority have told me they wished they had never had the surgery because of the residual problems later on.

Crap shoot.

 Who get's lucky? Most of the time, the House, some of the time, the gamblers.  

Thanks for asking.  I may add more later, right now I have a date with a shushi chef![/color]
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« Reply #5 on: May 08, 2007, 02:17:53 AM »

Quote

second gen,

You are not the first person to ask me this.  But I can only give you an ambigious answer.

Yes for some, no for most

Until it's understood HOW and WHY it works, a higher success rate most likely won't be fesable.  Once that mechanisim is understood, the proper screening can be done and implanted in those who will most likely benifit.  Right now it's all a crap shoot.  Can't say who it works for, can't say how much relief the get and can't say for how long the treatment will last.


Hmmmmm.... Sounds an awful lot like just about every antidepressant I've been on.



Quote
This is an "ALPHA" product.  The first of it's kind.  It's going to have all kinds of quirks and problems because there is nothing else to compare it to, yet.  Even though the baisc technology has been around since the 90's and they have "years" in terms of studies, it still quite new.

Understood.  I went into it, understanding that it might not work, and it might just be an expensive scar with a lump in my chest.  Or, it might be something that is going to change my life.  But I also knew, it wasn't going to do anything without giving it a try.



Quote
I am contacted by people all over the world with questions about VNS, with emails and phone calls wanting to know the same thing Does it work?   If you have been reading the forums, you will see it does work for a select group.  But for the majority, it does not.  And I think there are a few specific reasons, one being correctly diagnosed.  Epilepsy and depression are sometines very difficult to diagnose.


This is true. And presents the same problem when prescribing medications.  Sometimes, medications are prescribed incorrectly for depression, as well.  I know quite a few who were prescribed a medication for depression that subsequently touched off mania and made their symptoms even worse.  People who were quietly going about their life in the depths of depression, who were prescribed an antidepressant and the next thing they knew, they are in this new hell called mania and a whole other world of Bipolar Disorder.  Then, they're adding mood stabilizers and antipsychotics and antianxiety meds.... the list goes on.  Nothing in life is guaranteed.



Quote
Depression has many faces and many diagnoses as well.  It all depends on the doctor and what guideline he/she uses to assess the type of depression.  There are no industry standards for these assessment such as there are for disorders and diseases like...diabities type I, juvenial onset, type II, adult onset, or hepititis I,II,III 


Again, back to the previous answer, there are no guarantees.  And there are many other diseases and disorders that have symptoms that are used for diagnosis, not standards.  I have Lupus.  I can go to 10 doctors and not every one of them will agree that I have Lupus.  Does that mean I don't have it? No, it just means that some are less aggressive than others at treating my symptoms.  I will say, if I had stopped with the first doctor who poo pooed my symptoms and wanted to just have me stay out of the sun as a treatment, I would still be sick, and I would have stopped working 8 years ago due to fatigue and inability to function or think clearly.  Instead, I was properly diagnosed, treated, and I'm doing reasonably well.




Quote
Every person I have know personally who has had the VNS implanted, the devise no longer is effective.  Some had a year or 2 of  some relief, most had little or none.  And the majority have told me they wished they had never had the surgery because of the residual problems later on.

I am not sure how you can say this.  I see people here who say that it is working for them.  And you need to consider the fact that very often, especially on internet forums where people visit when they are down, but just don't have time to visit when life is going well, that it might just be that it's working, and they're just not here to tell you about it.

This is not the only forum I visit.  There are several others.  I see many people who say it works.  I see many who say it doesn't.  I see many people who say it's sort of working, but they have only had it for a short amount of time.  (Just like the forums I go to where people use medication alone.)

I also have to wonder how much of it's failure rate has to do with the fact that there are so many different medical professionals who have their hand in this?  The surgeon, the treating doctor, etc.  If it's not implanted correctly, it obviously won't work correctly.  If there are surgical complications, it will cause distress and delayed healing which would cause anyone more depression.

Add to that, aggressive doctors who might want to push the settings to the max, immediately which may not be the best treatment for everyone.  

I just think that saying something DOESN'T work when it does, just not 100% of time time (which I don't think Cyberonics has ever claimed) is misleading and discouraging.

I'm not trying to be a pain, here, but I came here for support and information, and it just seems negative. Like "I'm sorry you got this sh*tty implant, because it doesn't work, and Cyberonics lied to you, and you will experience a life of hell now, and for those of you that have positive experiences, it won't work for long".

I know that not everyone's experience has been positive.  But not everyone's experience has been negative, either.

It's not all black and white.

That's all I'm saying.....  It just seems like it would be more supportive, is all. I had a horrible time with a reaction to the surgical glue, dressing tape and a nasty yeast infection from the antibiotics.  I would hate to turn people away from a potentially beneficial treatment because I had a bad experience because that's the way MY body reacts.  At one point, I was convinced that due to my Lupus, my body was going to reject this thing because of a really bad week, post op.  I still wouldn't have discouraged anyone else from trying it.  Because it's the way I react.


I just wish, within the informative articles, there was less sarcasm and negative downgrading. I'll still read, and contribute, but I really don't feel like I'm getting support.  That's just how it feels to me, personally.
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« Reply #6 on: May 08, 2007, 02:29:53 AM »

Just a quick addition, you contradict yourself in your comments above:

"I am contacted by people all over the world with questions about VNS, with emails and phone calls wanting to know the same thing Does it work? If you have been reading the forums, you will see it does work for a select group. But for the majority, it does not. And I think there are a few specific reasons, one being correctly diagnosed. Epilepsy and depression are sometines very difficult to diagnose."

"Every person I have know personally who has had the VNS implanted, the devise no longer is effective. Some had a year or 2 of some relief, most had little or none. And the majority have told me they wished they had never had the surgery because of the residual problems later on."



Either it does work sometimes, or it no longer works for anyone you know.  It can't be both.  

And, there was a poll posted here recently:


Has VNS helped you?

According to that, 58% said "Yes, it got better".  

That is a higher percentage than what Cyberonics claims will be the success rate.



 
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Birdbomb
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« Reply #7 on: May 08, 2007, 09:45:07 AM »

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"Every person I have know personally who has had the VNS implanted, the devise no longer is effective. Some had a year or 2 of some relief, most had little or none. And the majority have told me they wished they had never had the surgery because of the residual problems later on."


I need to make myself a bit clearer on this statement.

I am speaking of my immedate circle of friends, NOT internet relationships.  People I see and know on a personal basis.  From my Epilesy support group to neighbors.   This group by no means represents the public as a whole, it just may be an unfortunate cluster of those not suited for VNS.

The success rate of the people I have met thru the internet is varied but for the most part falls in the "1/3" statistics of success.

Quote
I just think that saying something DOESN'T work when it does, just not 100% of time time (which I don't think Cyberonics has ever claimed) is misleading and discouraging.

I never claimed it didn't work.
 
At what point does it is stop being benificial?  And how do you rate success? 1 less seizure a day? 10? 20? When you have 100's?  Or just being able to dress your self? Or being a productive member os society no longer being financially supported by the government?  It all subjective.

There are so many variables that go into play with this treatment.

You asked me my opinion, then chastized me for having one.  Every member here has an opinion about VNS, it's a passionate topic.   But when reading these forums, you need to keep an open mind.  Those that come here are searching for commonality with others who have VNS, either support, questions or just to see if what they are experiancing is "normal"  Many stay, especialy those with on-going problems.

We have members with wonderful success like Labrat.  She is priceless to me because of her positive success.  Her opinion is different than mine, yet we find a place to share them both.  She is one of many.  Most people who have success, go on and pick up the pieces of their lives.  They move beyond the forums and back to living!  Once in a while they pop in to tell us how well they are, but they are busy now.  Those of us who do not share their success must still seek treatments that will help US have happy productive lives.

Maybe you need to dig a little deeper into these forums.  The reason WHY this message board was created and why it is so successful.  It has nothing to do with how well VNS works or who should recieve it, or what anyone's personal opinion is about it, or hidden agendas.  

Cyberonics used to have their own message boards. They closed them down not because of day traders, or abuse of the boards, but because patients were vocalizing their different problems and concerns.  The moderator ( who I will not name here) offered no answers, only the canned disclaimer written by the legal department and to call the 1-800 number.  These people were not asking for medical advice, just conformation of what they were experiancing was real and if others were experiancing the same things.

I took screen shots of the Cyberonics forums for the last month it was operating because I felt like they were going to close the boards.  I have forwarded some of those screen shots to reporters who interview me.  And I have been interviewed by The Houston Press, The NY Times, 20/20 just to name a few.  As a matter of fact, I still have regular communications with a few of these reporters.

Then Lo and Behold, Cyberonics closed the message board!  It was such a disservice to those members!  Like a kick in the face!  The company known for wineing and dining potental patients, the company that calls potential patients on a weekly basis to see how you're doing, until you get the implant.  The company who will communicate with patients as long as their VNS is a success, but the second you have a problem, they stop.

This site opened one week later.

Are there lots of complaints on this site?  Of course!  Do I allow my members to vent about the treatment?  Without a doubt? Can those who have shinning success brag?  I welcome it.  This site is for good, bad, whatever.  Support is where you seek it.  We will support you no matter the outcome of this treatment for you.[/color]
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Electrodes are in me for LIFE!
labrat
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« Reply #8 on: June 13, 2007, 10:48:50 AM »

I wish it worked for more people. Sometimes I wonder if the person (doctor) putting it in makes a difference.

I am soooooooo thankful to be one of the lucky ones My TRD would have killed me before this time.

Labrat      :im_033:  
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« Reply #9 on: November 09, 2011, 12:09:36 PM »

I wish they could have followed me for the last 11 1/2 years. Obviously they have no idea what TRD stands for which is a simply existing hell.


Labrat  :So Sad:     :im_033:  

As for where the term “treatment-resistant depression” he cited comes from, Cummins said, “We invented it.”
« Last Edit: November 09, 2011, 07:35:17 PM by dennis100 » Logged
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« Reply #10 on: November 09, 2011, 07:36:47 PM »

Fortunate ones
Insiders made nearly $50 million trading a money-losing company's stock
By Elliot Blair Smith
USA TODAY

.................
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On Aug. 26, 2004, Cummins wrote a passionate, 10-page reply to the same FDA office. He described himself “as an American citizen whose mother and grandfather suffered from treatment-resistant depression, and committed suicide because it was their only remaining option.”

He wrote that the FDA's decision against Cyberonics “insures that millions of Americans living today with chronic or recurrent treatment-resistant depression have only the same way out chosen by my mother and grandfather.”

“After finding my mother's body in her small apartment an estimated two weeks after her suicide,” Cummins wrote, “I can assure you that I know the sights, smells, tastes and despair that accompany the hopelessness of treatment-resistant depression and the only real way out.”

On Feb. 2, 2005, the FDA signaled in a letter to the company that it would approve Cyberonics' depression treatment after all. Over the next week, investors bid up the company's stock by 58% to a record $43.36 a share. And on Feb. 10, 2005 — his 51st birthday — Cummins' cashed out $14.7 million in stock options, netting $10.3 million after his trading costs.

Sharing his good fortune were nine other insiders, including CFO Westbrook and board compensation committee members Coelho and Appel. Cyberonics officials cashed out $19.9 million in trading profits that February, in the largest sale of stock by insiders in any month in company history, according to Thomson Financial.

But the letter that Cummins wrote to the FDA was inaccurate on several accounts, he acknowledged during an interview in August.

In that interview, Cummins conceded he did not discover his late mother's body. Rather, Cummins said, the Mercer County, Pa., coroner's office informed him of her death.

He also said he does not know whether his mother was diagnosed with depression, or if her death certificate says she committed suicide. In fact, the death certificate and coroner's report state she died of natural causes.

LINK
« Last Edit: November 09, 2011, 07:44:31 PM by dennis100 » Logged
dennis100
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« Reply #11 on: November 09, 2011, 09:22:53 PM »

My Commentary


1997

Cyberonics has a little device that increases seizures in 1/3 of the patients.

They ask the FDA to approve this thing to treat epilepsy.

The FDA says so long as you pay your Medical Device User Fees we don't give a shit.

Approval granted.

 

DR. COSTELLO: Good afternoon, Dr. Wilkinson and members of the panel. This afternoon, I will be discussing issues regarding the safety and effectiveness of the vagus nerve stimulation device......................One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.................This slide shows each of the studies and the percent seizure increase. As you can see, in each of the studies, there were patients who had greater than a 100 percent increase. In the E05 study, the range went up to a 234 percent increase, while in the E04 study, it went even higher, to a 680 percent maximum range.

pg. 125
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf

 

2004

Skip writes his passionate letter.
(see above post)

Approval granted for TRD.

 

2011

FDA getting bad press.

Looking into the matter.

Better get that gadget off the market before they write more nasty stuff about us.

 

2012

Device recalled.

Crimanal charges galore.

Huge scandal.

Prison time for Skip and others.

___________________________

That's got the makings of a great movie.


« Last Edit: February 24, 2012, 04:26:37 AM by dennis100 » Logged
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