VNS Therapy

[Bernard]

I saw an ad yesterday in the Houston Chronicle for a free, local seminar for VNS Therapy. This is a treatment that was featured recently (a few weeks ago at least) on the local news (ABC/Houston).

It consists of surgically implanting two devices:

• a device which stimulates the Vagus nerve in the neck every so often (5 minutes or so) in an effort to normalize brain activity
• A device in the chest which you can pass a magnet over at the onset of a seizure in an attempt to "short-circuit" the seizure

Stacy and I are considering attending the seminar to see what they have to offer, but the treatment seems a bit extreme to me. Having seen the success of EEG Neurofeedback in normalizing the brain function, I wonder if this method (for achieving the same end) is really necessary. I suppose, like most things associated with epilepsy, it depends upon the person/case.

If we are able to make the session, we will report back here to let you know about it.

[Bernard]

Well, Stacy and I went to the seminar and found it to be very informative. There were two reps from Cyberonics there, a Nurse Practitioner (Becky) from Texas Baylor College of Medicine & Texas Children's Hospital who works with epilepsy patients, A VNS Therapy patient (Susan) and a representative from the Epilepsy Foundation of Southeast Texas.

Becky gave the main presentation and Susan followed up with her experience. The VNS Therapy is pretty much what I expected after reading the VNS Therapy web site. Aside from the risk of infection that is present with any invasive surgery, the only real downside to the VNS Therapy is that you cannot get a full body MRI (should the need ever arise) and the generator (chest device) needs to be replaced (via outpatient surgery) every 5-12 years (for a new battery).

They claim that after 1-2 years of insertion, the system helps 47% of patients reduce seizures by more than 50%. Susan related her experience of going from 13 seizures a day to not having any in the last 7 years. But everyone was forthright in explaining that most patients do not completely eliminate seizures with the system, nor necessarily eliminate the necessity for continuing drug therapy.

It looks like something we might investigate further for Stacy if the neurofeedback therapy fails to achieve the results it managed before our first child was born.

[Bernard]

I found a page discussing The Vagus Nerve Stimulator (NCP) From A Patient's Point Of View. It is a good summary of what was presented at the seminar and offers additional details as well.

[Bernard]

The VNS Message Board contains quite a bit of surprising info about the system and Cyberonics. Definitely worth a read if you are interested in the therapy.

[Herb]

Bernard,

You may have some interested in perusing the following website:

vnsdepression.com

I extend my best wishes to you.

Warmly,
Herb

.

[Bernard]

Thank you Herb, I'll be sure to check it out.

Oh, and welcome to our forum!

[Herb]

Bernard,

You’re welcome. There are number of folks who are recipients of the VNS prosthesis for Epilepsy who would be more than willing to share experiences and knowledge with you and your wife should you decide to seek information in that direction.

I am very familiar with the prosthesis from a different therapeutic standpoint; TRD (Treatment Resistant Depression). I am also a very vocal advocate for education for the patient and/or loved ones and un-coerced and informed medical decisions.

In any event, I’ve already given you a link to enough reading to keep you busy. One of the folks on the vnsdepression.com website handles the Epilepsy side. His name is Mickey and he’s your neighbor down the road a piece. Mickey is from Galveston.

Once again, I extend my best wishes to you, Stacy and your family and most importantly for Stacy’s wellness that you all are striving to achieve.

Warmly,
Herb

.

[Bernard]

The Houston Press has published an article about VNS Therapy and Cyberonics in their usual style:

Exposed Nerve

Cyberonics has implanted its pacemaker in thousands of epileptics. It wants to expand to the depression market. Still needed: an accounting of those who died or were injured after receiving its implant.

In the article, Craig Malislow reports:

In medical terms, there is no explanation for the "mechanism of action," which means that no one -- not neurologists, not Cyberonics -- knows exactly why the device works. All that's understood is that vagus-nerve stimulation can reduce and even eliminate seizures in otherwise treatment-resistant epileptics.

and...

The FDA reported that the company relied on nonrandomized clinical studies with a potential bias. The agency also expressed concern over instances of study patients whose depression deepened, and the fact that there was no statistical difference between a group of patients who had the device turned on and a control group whose devices were off.

and...

"For the VNS, there was no evidence that the real treatment was better than the fake treatment," Malone says. "So then…you have a treatment that doesn't have evidence of working but does have evidence of side effects."

I don't get it. How does VNS Therapy become an approved option - endorsed by non-profit epilepsy organizations, hospitals and insurance companies (well, not endorsed, but covered anyways) without gold standard double blind studies published in peer reviewed medical journals while EEG neurofeedback is not even on the table for discussion when it has a greater depth of studies backing it and no known adverse side effects!.

[Herb]

Dear Bernard,

I do not have the time to answer your questions pertaining to the VNS ...[edited: Sorry Herb, but this forum is not the place to air grievances about individuals. Please stay on topic.] ... If you are interested in learning and understanding what has been going on with the VNS I’ve cut and pasted for you some recent starter material for you and your readers. I’ll get you started and then you can make your own judgments.

[more edited: reason stated above]

... You also might get acquainted with the CYBX financial forum on Yahoo. A number of folks have been posting to that site for years including yours truly. Many discuss financial issues but my participating deals with advocacy and wellness as it pertains to the VNS therapy. ... [edited: same reason] ... If you’re interested in answering your questions, the information is out there both bad and good and as I mentioned.

One last point, the reporter Craig Malisow and I have shared a number of telephone and E-mail collaborations. I think his efforts we’re well meaning, noble and he did dig out information I was curious about for a number of years but I believe his article overall was slanted and I pointed this out to him respectfully today, along with the information I’ve listed for you below.

Warmly,
Herb

We all now have a perfect illustration of the importance to research and educate oneself and to converse with one’s own trusted, compassionate and caring physician. No sooner than this reporter, Craig Malisow, writes what I consider an “alarmist” article lacking the substance and understanding of these illnesses than the following notification was received by Cyberonics:

FDA Notifies Cyberonics That Its Warning Letter Response Is Complete and Adequate
Thursday April 7, 8:00 am ET

...

haha. Looks like the article is a desperate attempt by the shorts to move the stock lower so they can cover for a good price before final approval. The author is misrepresenting the facts and trying to mislead investors. He implies that Cyberonics' "pacemaker" may be a cause of the deaths between 2001 and 2003, yet he fails to point out that it is well within range for epileptic patients. It's common for deaths to occur among epileptic patients due to a mysterious condition known as "sudden unexplained death in epilepsy"(Sudden Unexplained Death in Epilepsy). Actually, VNS patients fared even better than statistical average when you take into account that their epileptic conditions are more severe. Follow the links below to learn more about Sudden Unexplained Death in Epilepsy:

http://www.pubmedcentral.nih.gov/art...i?artid=320690

http://www.e-epilepsy.org.uk/pages/a...cle.cfm?id=108

Sudden Unexpected Death In Epilepsy

A conference call to discuss this press release will be held at 12:00 PM EDT on Thursday, April 7, 2005. To listen to the conference call live by telephone dial 877-451-8943 (if dialing from within the U.S.) or 706-679-3062 (if dialing from outside the U.S.). The conference ID is 5447342; the leader is Pam Westbrook. A replay of the conference call will be available two hours after the completion of the conference call by dialing 800-642-1687 (if dialing from within the U.S.) or 706-645-9291 (if dialing outside the U.S.). The replay conference ID access code is 5447342

[Bernard]

I do not have the time to answer your questions pertaining to the VNS ...

You don't have the time, but you do know the answer? Or was that a figure of speech to segue into what you really wanted to say?

You also might get acquainted with the CYBX financial forum on Yahoo. A number of folks have been posting to that site for years including yours truly. Many discuss financial issues but my participating deals with advocacy and wellness as it pertains to the VNS therapy.

My questions are related to how VNS Therapy is considered a legitimate treatment for epilepsy without the rigorous studies that are usually required for same. Why is VNS Therapy given greater consideration by the medical establishment than EEG Neurofeedback? I have not visited the financial forum you mention yet, but I seriously doubt that investors can answer for the medical establishment.

Since you appear to be so heavily engaged on behalf of Cyberonics, is it safe to assume that you are also vested in the company (ie. have you invested in the company / bought shares)? Do you work for them? Are you one of the volunteers that talk about your experiences at their marketing seminars?

One last point, the reporter Craig Malisow and I have shared a number of telephone and E-mail collaborations. I think his efforts we’re well meaning, noble and he did dig out information I was curious about for a number of years ...

Would you mind elaborating?

haha. Looks like the article is a desperate attempt by the shorts to move the stock lower so they can cover for a good price before final approval. The author is misrepresenting the facts and trying to mislead investors.

It did not appear to me that the article was aimed at investors.

He implies that Cyberonics' "pacemaker" may be a cause of the deaths between 2001 and 2003, yet he fails to point out that it is well within range for epileptic patients. It's common for deaths to occur among epileptic patients due to a mysterious condition known as "sudden unexplained death in epilepsy"(Sudden Unexplained Death in Epilepsy). Actually, VNS patients fared even better than statistical average when you take into account that their epileptic conditions are more severe.

The Houston Press article states that there were 81 deaths of VNS Therapy patients between 2001 and 2003, but it does not state how many total VNS patients there were for the same time period, so the individual who posted the info above did not establish what the ratio of unexplained deaths for VNS patients was. His/her claim that the VNS patient death ration is "within range" cannot be substantiated without that info.

Further, and more importantly, the point of the Houston Press article (at least in regards to this issue) was that Cyberonics did not mount a rigorous investigation to determine if the 81 deaths were, in fact, Sudden Unexplained Death in Epilepsy, or perhaps complications related to the VNS. I'm not comfortable making an assumption that all 81 deaths were Sudden Unexplained Death in Epilepsy. Without thorough investigations, no one will ever really know.

[Herb]

Dear Bernard,

The first point I’ll make is that I am considerably older than you and with that I bring to the table experiences, research, knowledge, observations and collaborations over those years. With that also comes the point that through formal training I don’t tell people what to do, I share.

I’ve given you several sources of information that can start answering some of your questions although it appears you haven’t bothered to read. Feel free as you’ve already done to make your own decisions whether any source of information is worthwhile reading. CYBX Yahoo forum is intended to be a financial discussion forum but when one reads every posting, as I did the former Cyberonics message forum and continue to do so on the Yahoo site; I’ve personally found valuable information from some intelligent, literate and knowledgeable participants. If you’re predisposed to immediately invalidate sources, it’s your choice. I still continue to read Bird’s forum as every once and awhile someone shares personal experiences that increases my knowledge. My personal feelings for the value she offers others, I put aside. It still represents a potential source of information especially as it relates to experiences as does your site and others. I try to read as many as possible.

My time is more valuable elsewhere. Yes, I have knowledge and I’m answering you by directing you to that knowledge. You make your own decisions about that which you read.

My questions are related to how VNS Therapy is considered a legitimate treatment for epilepsy without the rigorous studies that are usually required for same. Why is VNS Therapy given greater consideration by the medical establishment than EEG Neurofeedback? I have not visited the financial forum you mention yet, but I seriously doubt that investors can answer for the medical establishment.

Try starting back at the FDA Device requirements to understand what a study entails. Why do you make the assumption “rigorous studies” were not performed? Have you read any of the protocols or studies and more importantly do you understand the differences between device studies and pharmaceutical studies? Again, I do not address myself to Epilepsy as I’ve told you previously although there are many similarities in treatments as well as VNS therapy. I know nothing about EEF Neurofeedback.

Since you appear to be so heavily engaged on behalf of Cyberonics, is it safe to assume that you are also vested in the company (ie. have you invested in the company / bought shares)? Do you work for them? Are you one of the volunteers that talk about your experiences at their marketing seminars?

I answered your questions above by sourcing web links.

It did not appear to me that the article was aimed at investors.

Obviously your naïve about short-sellers and their far reaching hands. ...[edited: please refrain from unnecessary personal attacks]... and not to mention the timing of the article to closely coincide with the FDA potential approval date.

The Houston Press article states that there were 81 deaths of VNS Therapy patients between 2001 and 2003, but it does not state how many total VNS patients there were for the same time period, so the individual who posted the info above did not establish what the ratio of unexplained deaths for VNS patients was. His/her claim that the VNS patient death ration is "within range" cannot be substantiated without that info.

There were over 500 deaths if I recall from 1987 through 2004. Not one has been attributed to the VNS. Listen in to the teleconference or more importantly, participate and get information first hand instead of the dribble that appears on many message forums. If you’re interested, educate yourself about me by reading. I’m not a newcomer to TRD (Treatment Resistant Depressive) and I don’t spend my time blaming the world for our challenges and failures but I am appreciative of the professionals and study subjects with whom I’ve collaborated for over 5 years and others that add to my education and knowledge.

Further, and more importantly, the point of the Houston Press article (at least in regards to this issue) was that Cyberonics did not mount a rigorous investigation to determine if the 81 deaths were, in fact, Sudden Unexplained Death in Epilepsy, or perhaps complications related to the VNS. I'm not comfortable making an assumption that all 81 deaths were Sudden Unexplained Death in Epilepsy. Without thorough investigations, no one will ever really know.

That was Craig’s opinion gathered by whatever means he could. I directed him to the very same sources of information that I’ve directed you and your readers. If you’re not comfortable with the reports of Sudden Unexplained Death in Epilepsy, good for you, you’re a thinking man and I appreciate people who are not so easily accepting. So do something about! You read of the medical errors so what are you doing? I participated in the conference call to see what the company is doing about this issue. I got an answer directly, not second or third hand. I can only hope in fact that what I am being told is being initiated on behalf of others to follow. You don’t believe or like what your physician is telling you, object and state your case. You want to make medical decisions as others have done by listening to a company sales rep; that’s their prerogative but I certainly would not.

I’m not the smartest fellow on the block but I do considerable research as it pertains to TRD so when I do speak to the professionals I may not know the precise lingo, chemistry, neurology etc but my understanding of what is taking place indicates to them that I am versed on the subject. As per our meeting with Joyce’s doctor today, we are in agreement as it pertains to the brain, we are only in the infancy of what there is to know and what is offered to the patient is nothing more than theorizes without definitive answers and certainly no cures at this time. Therefore, I am at times at odds with some doctors and their recommended proposed treatment regimes and at that time, based upon my accumulated knowledge and experiences I’ll make a decision for the whole person, my wife, and what I consider best for her wellness because my empirical observations and theorizes have been more beneficial toward her wellness than some of their book learning’s.

Until the day comes when they know definitively how the brain works and they have a cure for all brain illnesses what is left to all of us is the “Trial and Error Approach to Wellness” and being educated and working with a trusted, compassionate, caring and knowledgeable health care practitioner(s).

Warmly,
Herb

[Bernard]

I’ve given you several sources of information that can start answering some of your questions although it appears you haven’t bothered to read. ... CYBX Yahoo forum is intended to be a financial discussion forum but when one reads every posting, ...

I'm rather busy Herb. This site is not a business and I'm not retired. It would be helpful when answering a question to point to a specific post instead of just saying, "here's a financial forum with answers to your questions".

My time is more valuable elsewhere. Yes, I have knowledge and I’m answering you by directing you to that knowledge.

Everyone's time is valuable Herb. But actions speak louder than words and so far, you last post is the first one that did not include a link drop to your forum or that I would consider posted mainly to recruit this forum's visitors. As mentioned above, you did not answer my questions directly (and that's OK - but claiming that you did is disingenuous).

Try starting back at the FDA Device requirements to understand what a study entails.

Now we are getting somewhere. Do you have a source for the FDA device requirements? Is the FDA device requirement the only hurdle required for acceptance by the medical industry? It was my understanding from researching Neurofeedback, that "gold standard" double blind placebo controlled studies were required for acceptance by the industry.

Why do you make the assumption “rigorous studies” were not performed?

According to the Houston Press article (emphasis mine):

The FDA reported that the company relied on nonrandomized clinical studies with a potential bias. The agency also expressed concern over instances of study patients whose depression deepened, and the fact that there was no statistical difference between a group of patients who had the device turned on and a control group whose devices were off.

Richard Malone, a psychiatrist and professor of psychiatry at Drexel College of Medicine in Philadelphia, was one of two advisory panel members to vote against recommending the treatment for depression.

"For the VNS, there was no evidence that the real treatment was better than the fake treatment," Malone says. "So then…you have a treatment that doesn't have evidence of working but does have evidence of side effects."

Have you read any of the protocols or studies and more importantly do you understand the differences between device studies and pharmaceutical studies?

No, but I think this may be the critical piece to the puzzle (at least, from my perspective). I'm just a lay person who is seeking answers right now, because the VNS Therapy seminar I attended in conjunction with the info I've read on the 'net is painting a disturbing picture for me.

I answered your questions above by sourcing web links.

No, you did not, as I mentioned before. It is entirely disingenuous for you to attempt to "share" your perspective as a disinterested third party if you are closely tied to Cyberonics. I don't mind you sharing here and welcome an exchange of information, but I deplore dishonesty.

Obviously your naïve about short-sellers and their far reaching hands. ... and not to mention the timing of the article to closely coincide with the FDA potential approval date.

Well, if conspiracy theories are on the table, then the issues surrounding Cyberonics apparent failure to adequately address and/or disclose serious problems with VNS and their relationship with the FDA are fair game too, right? Is an investment in CYBX akin to taking blood money?

There were over 500 deaths if I recall from 1987 through 2004. Not one has been attributed to the VNS.

Herb, there are flaws in the system. The fox is in charge of the chicken coop and the fox does not appear to have scruples.

That was Craig’s opinion gathered by whatever means he could. I directed him to the very same sources of information that I’ve directed you and your readers.

I have read similar complaints from VNS patients and their families around the 'net. I don't claim to know the truth, but the old adage, "Where there's smoke, there's fire" comes to mind.

Unfortunately, it appears that CYBX alone is charged with handling investigations on the matter and there is an inherent conflict of interest there.

If you’re not comfortable with the reports of Sudden Unexplained Death in Epilepsy, good for you, you’re a thinking man and I appreciate people who are not so easily accepting. So do something about! You read of the medical errors so what are you doing?

I'm asking questions and researching as I'm able. What are you doing?

I participated in the conference call to see what the company is doing about this issue.

What conference call? Who is sponsoring these conference calls? Are they anything more than marketing tools for CYBX?

I got an answer directly, not second or third hand.

An answer to what? As I mentioned previously, actions speak louder than words. So far, CYBX's track record in investigating problems appears to be very inadequate given the seriousness of the issue.

You want to make medical decisions as others have done by listening to a company sales rep; that’s their prerogative but I certainly would not.

... and this brings us back to the crux of my initial question: How did VNS Therapy get medical acceptance (this is different from FDA approval) with the cloud of issues and side effects surrounding it when a safe, effective alternative is ignored? I hope to find the answer.

[ellgee]

Here's the conference call link - I hope it works:

http://www.cyberonics.com/media/ConCall_040705.mp3

It takes a few minutes for media player to load up.

[Herb]

Dear Bernard,

In my posting of “Thu Apr 07, 2005 9:36 pm Posts: 6” listed above, amongst a number of links to answer some of your questions, I posted the following information:

A conference call to discuss this press release will be held at 12:00 PM EDT on Thursday, April 7, 2005. To listen to the conference call live by telephone dial 877-451-8943 (if dialing from within the U.S.) or 706-679-3062 (if dialing from outside the U.S.). The conference ID is 5447342; the leader is Pam Westbrook. A replay of the conference call will be available two hours after the completion of the conference call by dialing 800-642-1687 (if dialing from within the U.S.) or 706-645-9291 (if dialing outside the U.S.). The replay conference ID access code is 5447342.

Either you overlooked this piece of information or at the time you had no interest or preconceived notions in listening into the conference and the information supplied. The important point is that had Mr. Craig Malisow waited about a day or so before publishing his article many of his presented issues would have been addressed. Again, you might find it interesting to call “800-642-1687…The replay conference ID access code is 5447342” nor would I ever dismiss reading any information pertaining to a therapy being utilized by my spouse even if it is posted on a financial forum. One never knows where the next helpful piece of information can come from. As an apparently intelligent and well educated individual it appears to me you come with a number of preconceived notions such as “Why is VNS Therapy given greater consideration by the medical establishment than EEG Neurofeedback?” Is that a statement of fact? If so, please cite the documentation?

Since you appear to have preconceived notions and also a need to edit, censure and/or delete postings of mine it raises an uncomfortable feeling and level for me. Since I’m not interested in advertising my website but sharing information regarding the VNS therapy I’ll just answer you by saying if you took the time to read the Website you might find a number of answers to your questions and clarity to your confusion as illustrated by your question “How did VNS Therapy get medical acceptance (this is different from FDA approval).” Quite simply, you’re confusing the FDA approval of the VNS therapy for Epilepsy with the FDA current “approvable” status of the VNS therapy for Depression which is expected to receive formal “approved” status in May of 2005. If I am also correct in my recollection, the company ran four depression studies sanctioned by the FDA one of which had a protocol requiring the double blinding of the participants. It might also benefit you to read the actual transcript of the FDA Device Panel of Experts meeting of June 2004 regarding the depression studies which you’ll find posted on the Website under Depression - Articles. Since you may find my directing you to information contrary to your notions or inclinations I would suggest you then get all your information and answers regarding VNS Therapy and Epilepsy from your friends and that very special health care professional, knowledgeable in Epilepsy, who post to your friend’s forum ...[edited: Herb, please keep your personal differences with people to yourself or your own forum. This forum is not the place to air grievances.]...

If you have interest in discussing the VNS therapy, as a treatment option and where articles that I research are posted to a Website without opinions on my part and a message forum where postings are not edited, censured or deleted, you know where to find me and I shall gladly share with you. Also please feel free to collect, cut and paste anything you deem worthwhile as my intentions have always been to share and not give advice and I have nothing whatsoever to hide including having already answered your allegations and/or assumptions of my relationship with Cyberonics. Again I cite for you on the Website, long before you made your statements, under the topic Disclosures.

I might also point out to you that you’ll find follow up correspondence with Mr. Malisow regarding his article on the message forum under the Depression – Discussions. I believe the topic is “Wrong Information.” It too might or might not open your eyes or at least give you some thought.

I am sorry that your wife Stacy is having difficulties and that her prior treatment regimens are not as effective as before. The human body is dynamic and forever changing. Although I am not qualified to discuss Epilepsy I can tell you that TRD requires my constant vigilance to keep “the beast” controlled and stabilized and from wrecking havoc on our lives. As I have also learned one cannot be complacent and that is my reasons for constantly researching. I know that I cannot be assured that any of my spouse’s treatments will not also prove refractory as in years past.

Warmly,
Herb

.

[Bernard]

In my posting ... listed above, ..., I posted ...“A conference call to discuss this press release ...”

I saw the info. As best as I can tell, it is just a marketing forum for CYBX to discuss their own press release. While I appreciate the info, it did not appear to address the topic that I am interested in.

Either you overlooked this piece of information or at the time you had no interest or preconceived notions in listening into the conference and the information supplied.

Herb, do you realize how condescending you are when you post stuff like that?

The important point is that had Mr. Craig Malisow waited about a day or so before publishing his article many of his presented issues would have been addressed.

I have not listened to the call (yet?), but there are a couple of points that should be addressed here:

• Newspapers like the Houston Press do not decide what stories to run one day in advance. They have an editorial schedule laid out weeks in advance.
• If CYBX had answers to the most important criticisms regarding their apparent lack of effort in investigating patient deaths or more detailed accounting for deaths of underage (per FDA approval) patients being automatically categorized as "user errors", they could have shared that with the reporter before their conference call to discuss a press release.

As an apparently intelligent and well educated individual it appears to me you come with a number of preconceived notions such as “Why is VNS Therapy given greater consideration by the medical establishment than EEG Neurofeedback?” Is that a statement of fact? If so, please cite the documentation?

I'm glad you are at least smart enough to recognize my brilliance. (Sounds condescending, doesn't it? Hint, hint).

My statement was my opinion based upon the fact that GPs, neurologists, hospitals and insurance companies recognize and in some cases promote VNS Therapy while being completely ignorant of EEG Neurofeedback as a completely safe and very effective alternative. For example, at the VNS Therapy "seminar" that we attended, the nurse practitioner from Texas Children's Hospital and Baylor College of Medicine did not know anything about EEG Neurofeedback - and she has been recommending patients try VNS for years. I could understand the recommendation if it truly was a measure of last resort, but it bothers me tremendously that a viable alternative is ignored first.

Since you appear to have preconceived notions ...

What you call preconceived notions, I call current opinions.

.. and also a need to edit, censure and/or delete postings of mine it raises an uncomfortable feeling and level for me.

Herb, your posts contained personal attacks and possibly slanderous statements regarding a third party (who is not even present in the discussion, not that it matters). That will not be tolerated here. You are always welcome to direct any complaints about my moderating talents directly to me via PM (private message), but I'm not going to allow public crying about it. No one wants to read it. This is the final word on this subject. Anything else you would like to say on the subject you may say via PM (private message) with me.

... Quite simply, you’re confusing the FDA approval of the VNS therapy for Epilepsy with the FDA current “approvable” status of the VNS therapy for Depression ...

No Herb. You have misunderstood me. The distinction between FDA approval for epilepsy vs. depression is quite clear and not at all what concerns me. Don't worry though, I am doing my own research and will post my findings.

... It might also benefit you to read the actual transcript of the FDA Device Panel of Experts meeting of June 2004 regarding the depression studies which you’ll find posted on the Website under Depression - Articles.

Thanks. I don't understand why you are republishing copyrighted articles in their entirety on your web site when you could just direct folks to the original source:

FDA Device Panel of Experts meeting of June 2004

I noticed that you did that with the Houston Press article as well. Did you get their permission to republish their article?

I am sorry that your wife Stacy is having difficulties and that her prior treatment regimens are not as effective as before.

She is actually doing much better now. I think the LENS Neurofeedback is starting to generate noticable results. The results timetable does appear to be ahead of the curve established by the previous EEG Neurofeedback treatments.

[Bernard]

Hmm.. Looks like there are others who are wondering the same things I am (emphasis mine):

“The principle is simple: If it doesn’t work, it shouldn’t be approved,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “The FDA would never approve a drug under these conditions. They certainly shouldn’t approve this device.”

The agency itself has raised questions about increased suicides, worsening depression and sudden death in patients using this device – all of which require further investigation, Public Citizen said.

Electronic Device Should Not Be Approved for Treatment of Depression, Public Citizen Tells FDA

While this press release from a nonprofit consumer advocacy organization is regarding Cyberonics bid for FDA approval for VNS for depression, I have to assume that the problems that need investigating are with the 30,000 epilepsy patients.

The FDA also raised questions about the role of the VNS device in sudden death. “There is a concern that this might be due to cardiac events due to the direct vagal nerve stimulation,” said the FDA’s Dr. Schlosser at the Advisory Committee meeting. “Could this be causing a cardiac event that led to sudden death?” he asked. ...

Letter to FDA urging that the Vagus Nerve Stimulator not be approved for treatment of depression (HRG Publication #1741)

I'm just flabbergasted by what I'm reading. There are so many unanswered questions over safety concerns. I can't understand how the FDA ever gave VNS approval for epilepsy in the first place.

[Herb]

Dear Bernard,

You will continue and remain amazed if you prefer to limit your resources to information and research based upon Malisow’s article which was addressed and answered and yet you preferred to ignore investigating sources of information and now a 12th hour sensationalist attempt rehashing the same points that has been addressed from the June 2004 FDA Device Panel Meeting of Experts and thereon.

While you remain amazed I’ll once again suggest and direct you to vnsdepression.com if you are interested in the VNS Therapy as there is information that might allay your amazement but more importantly give you answers to some of the questions you may have.

You read a letter and stand in amazement and I on the other hand have carefully followed a research study for over 5 years to keep abreast of the facts and more importantly, in this instance, I delve into the signatories to that letter which has amazed you. Maybe a little checking would be revealing. Maybe a little checking into who funds the organization may be in order. Maybe a little checking into where were these folks since June of 2004. What purpose does a 12th hour letter really serve and why were there leaks beforehand? Who are the doctors that signed the letter and what are their qualifications? Would you care to have me continue? I also delved into Mr. Malisow’s questions and pointed out to him that his research in my eyes was somewhat incomplete and makes his questions seem more alarmist than the actual facts. Did you ever bother to research how many people die from Epilepsy each year that do not have the VNS Therapy? You might find that amazing. Maybe even investigating a financial message forum such as the CYBX Yahoo forum might enlighten you although you preclude that source from having any value. I on the other hand research and read first and then form my own opinions.

I don’t discuss Epilepsy as I’ve told you previously because I simply am not experienced and/or knowledgeable about the illness but I am qualified to discuss TRD and the VNS therapy as it relates to the treatment of depression. There are no safety issues that I am aware of at the moment. The therapy has been in use for Epilepsy for some 10 years and a little more than 5 years in depression. There have been no deaths attributed to the VNS in any depression subjects and for that matter there also have been no deaths attributed to the VNS Therapy in any Epilepsy patients and if my memory serves me correctly the dates covered were from 1987 to 2004. The VNS Therapy is efficacious for a percentage of depression study subjects and more specifically my spouse is almost continuously depression free without the use of psychotropic medications for about 4 years without any current side-effects.

In my opinion you shouldn’t act like some other alarmists that I know. You just might frighten some folks away from a potentially beneficial treatment option. As a suggestion, stop being amazed and research some before making any exclamations. Post your information for the readers and participants to share and discuss and maybe they can add their wealth of experiences and knowledge to what you may not know and at the same time try to do some investigation and maybe get to the source. Maybe you’re amazement might change to disgust as you might find there are ulterior motives and reasons for letters such as the PC document and they have nothing to do with patient wellness.

Being flabbergasted is okay for some of the folks whose posts I read but I’m sure you are capable and can do much better through research and education and arrive at a more reasoned response.

As a long time support person and health care advocate, nothing amazes me any more.

Warmly,
Herb
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[Bernard]

Herb, your attempts at innuendo to discredit the source I quoted is comical. If you have proof of a huge conspiracy, just post it.

If you re-read my post, you will see that what I found amazing is what the FDA had to say. Are they in on the conspiracy too?

I on the other hand research and read first and then form my own opinions.

This is a discussion forum Herb. Perhaps the medium is unfamiliar to you, but people are free to ask questions and discuss topics here without pretense of being an expert.

... I am qualified to discuss TRD and the VNS therapy as it relates to the treatment of depression.

Has Cyberonics or the FDA certified you in this regards? Have you studied all the confidential studies that are being discussed, but not published? Certainly you don't believe that following one case study (your wife's) qualifies you to make authoritative statements regarding the efficacy and safety of VNS Therapy for TRD?

There are no safety issues that I am aware of at the moment.

Please re-read this thread Herb. If you are relying on Cyberonics for your research, that is hardly surprising. Fortunately, it appears that the FDA is not so blind.

In my opinion you shouldn’t act like ...

IMO, you shouldn't talk down to people. Your condescending delivery really destroys the impact of any argument you are trying to present.

As a long time support person and health care advocate, ...

Let me be brutally honest with you Herb - and this is how I see it. You come off as someone who is heavily vested in Cyberonics. You are blind to all criticisms and substantive issues surrounding VNS Therapy. You crusade for VNS anywhere you can find an audience. IMO, you have zero credibility on the issue.

[Herb]

Dear Bernard,

I thank you for your response and I shall answer you once again as follows. You stated “If you re-read my post, you will see that what I found amazing is what the FDA had to say:”

The following is what you quoted from the PC document:

“The FDA also raised questions about the role of the VNS device in sudden death. “There is a concern that this might be due to cardiac events due to the direct vagal nerve stimulation,” said the FDA’s Dr. Schlosser at the Advisory Committee meeting. “Could this be causing a cardiac event that led to sudden death?” he asked. ...”

I read your statement and I shall repeat for you because you may have missed my presentation of information:

“There have been no deaths attributed to the VNS in any depression subjects and for that matter there also have been no deaths attributed to the VNS Therapy in any Epilepsy patients and if my memory serves me correctly the dates covered were from 1987 to 2004.” – Herb

If my memory also serves me correctly this same question was posed by Mr. Malisow and answered the same or the next day. There have been 524 deaths to date of recipients with the VNS Therapy and none of those deaths have been attributed to the therapy. Now in your amazement would you kindly be “brutally honest” and direct me to information to the contrary.

“You shouldn't talk down to people.” - Bernard

As is sometimes my nature by suggesting sources of information to become informed and educated as a response to one’s suggesting and/or making blatant statements is your perception of “talk down to people” then maybe you should research and read and take the time to talk to me in kind. I on the other don’t have the same perceptions or misperceptions as you based upon my knowledge and I personally don’t find it condescending when others share personal experiences and/or direct me to information to educate myself or in presenting another viewpoint.

“This is a discussion forum Herb. Perhaps the medium is unfamiliar to you, but people are free to ask questions and discuss topics here without pretense of being an expert.” – Bernard

Message forums are a medium I am extremely familiar with and have greatly benefited from and it is through one of these sources of information, the original Cyberonics Message Forum and the sharing of experiences and knowledge by the Epilepsy participants that we originally formulated our decisions to enter the study program for depression. While on the subject of that message forum, in which I participated for over 4 years and read every single posting, not one support person reported the death of a love one to further answer PC document and your FDA quotation and Malisow’s assertions and your amazement.

If your criteria for your exclamations are based upon the Malisow and PC document then I am inclined, in my opinion, to believe you are extremely naïve and not well researched on the subject as it appears obvious to me. [edited comment] There is information available on the subject matter and by way of definition:

“Expert -
Noun: a person with special knowledge or ability who performs skillfully,”
http://www.onelook.com/?w=expert&ls=a

Have you had the opportunity to collaborate with the researchers knowledgeable about the VNS Therapy? I have and still do. Why not contact them and ask your questions and report back to this forum?

In keeping with your definition of this medium “people are free to ask questions and discuss topics here without pretense of being an expert.” I am a lay-depression expert to my spouse and I would hope that you understand my knowledge, as opposed to your perceptions, based upon research, collaborations and knowledge and your innuendos, based upon two documents with questionable expertise and your statement “your attempts at innuendo to discredit the source I quoted is comical” is in fact not comical to me as you would rather base your exclamations upon the lack of your research and information and you would rather spend the time discussing my personal attributes and personality.

That being the case I shall share with you the fact that I was a former entrepreneur, principal and business executive who ran a multimillion dollar organization and although the door to my office was open to anyone, at any time to discuss any matter there is point at which I would question “where is this going.” You’re certainly free to maintain whatever perceptions you wish to maintain regarding the VNS Therapy. I have made an attempt to accumulate the resources and information unbiased in one location on the subject matter for many reasons and share with those challenged by TRD. I might also point out and once again correct any of your misperceptions. I advocate for education first and all treatment options and informed and un-coerced medical decisions by the patient and/or support persons in collaboration with trusted, compassionate, knowledgeable and licensed health care practitioner(s). It just so happens that I may have a little more knowledge than others as it pertains to the VNS Therapy for depression.

Lastly you stated:

“And this is how I see it. You come off as someone who is heavily vested in Cyberonics. You are blind to all criticisms and substantive issues surrounding VNS Therapy.” – Bernard

Your statements again obviate the fact you never bothered to look for the answer(s) and/or information when the source(s) was given to you but are more comfortable making exclamations without knowledge or understanding. I wonder who really is condescending and talking down to others. I on the other hand will only attribute your misperceptions to the lack of research and information.

Warmly,
Herb

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[Bernard]

I thank you for your response and I shall answer you once again as follows.

There is no need to repeat yourself. It adds nothing to a conversation to parrot the same thing over and over.

You might find it surprising, but it is possible for intelligent people to have read the sources you cited and still arrive at different conclusions from your own. You assume and presume too much IMO.

There have been 524 deaths to date of recipients with the VNS Therapy and none of those deaths have been attributed to the therapy. Now in your amazement would you kindly be “brutally honest” and direct me to information to the contrary.

Herb, you are the one who has missed the point. The fox is in charge of the chicken coop. The FDA and other disinterested third parties have concerns about Cyberonics efforts at investigating the deaths. There is no proof, but you prefer to be a CYBX pollyanna even when people's lives are at stake. But I guess it makes sense if you have a lot of money invested in them.

... I on the other don’t have the same perceptions or misperceptions as you based upon my knowledge ...

Agreed. You have your own perceptions and misperceptions.

Have you had the opportunity to collaborate with the researchers knowledgeable about the VNS Therapy?

Nope. I'm not a big time investor. But I put much more credance into FDA concerns than partisan company employees.

It just so happens that I may have a little more knowledge than others as it pertains to the VNS Therapy for depression.

Perhaps you should share that with the FDA and Public Citizen. So far, it appears as if Cyberonics themselves are not capable of making their case effectively.