VNS Therapy

[Herb]

Dear Bernard,

Am I the one that is missing the point?


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

“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.” – Bernard

For your information one of the “disinterested” parties, “The FDA,” has received, acknowledged and approved the documentation or what you refer to as “proof.” Maybe a little education is also warranted on your part as to “The fox is in charge of the chicken coop” as it relates to drug studies.

“…it is possible for intelligent people to have read the sources you cited and still arrive at different conclusions…” – Bernard

I concur with your thought and the very reason I continue to research and educate myself and not limit or exclude my access to any resource and the reason I search for anyone willing to share with me.

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

Hmm! Is that to be perceived as another one of those exclamations and/or innuendos on your part without research or knowledge? No need for me to repeat anything here as this is another of those “where is this going” exclamations in my perception only what does that have to do with getting to the source of the information which I do and was politely trying to direct you to.

“Perhaps you should share that with the FDA.” – Bernard

I have on a number of occasions. I’m sure Dr. Schultz is familiar with my correspondence, experiences, research, knowledge and advocacy for those that suffer from TRD.

“So far, it appears as if Cyberonics themselves are not capable of making their case effectively.” – Bernard

My perception of the above statement is that it is your opinion and is unsubstantiated. My response and statement of fact is that many of the issues addressed by the “disinterested” FDA have been resolved along with my previous statement regarding the deaths of VNS patients.

At some point I was hoping to read an opposing point of view backed by some documentation that is new and not “repeating” or rehashing issues already addressed and accepted by the “disinterested” FDA.

I can appreciate your naivety to think the FDA is a totally “disinterested” party as well as some of the other parties you allude to but I on the other hand have learned to always question studies, researchers, doctors etc for their underlying motivations and/or influences. I also have the perception that you have given little thought or concern to any vested interests the pharmaceutical industry might have in these issues.

Warmly,
Herb

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[Bernard]

... downside to the VNS Therapy is that you cannot get a full body MRI (should the need ever arise)...

The FDA issued a warning on this topic recently:

FDA Public Health Notification: MRI-Caused Injuries in Patients with Implanted Neurological Stimulators

(You are encouraged to copy and distribute this information)

Issued: May 10, 2005

This is to remind radiology personnel and physicians that serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures, and to recommend preventive actions.

Background

The FDA has received several reports of serious injury, including coma and permanent neurological impairment, in patients with implanted neurological stimulators who underwent magnetic resonance imaging (MRI) procedures. The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue. Although these reports involved deep brain stimulators and vagus nerve stimulators, similar injuries could be caused by any type of implanted neurological stimulator, such as spinal cord stimulators, peripheral nerve stimulators, and neuromuscular stimulators.

Recommendations

If you are a physician who implants or monitors patients with implanted neurological stimulators:

• Explain to the patient what MRI procedures are and stress that they must consult with the monitoring physician before having any MRI exam to find out whether it can be performed safely.

If you are a radiologist or health care professional who uses MRI equipment:

• All patients should be carefully screened for any implanted devices prior to performing an MRI procedure, even if the implanted device has been turned off. Also question patients about previously implanted devices that have been removed. Leads, or portions of leads, often remain in the body after pulse generators are removed, and these may act as an antenna and become heated.
• If the patient does have an implanted neurological stimulator, consider consulting with the referring physician to discuss other imaging options. For some implanted neurological stimulators, certain MRI procedures are contraindicated and cannot be performed.
• If an MRI procedure is to be performed on a patient with an implanted neurological stimulator, be sure to review the labeling for the specific model that is implanted in the patient, with particular attention to warnings and precautions. The radiologist may need to consult with the implanting or monitoring physician for this information. Also note and follow any instructions exactly for MRI imaging that may be in the labeling for the implant, including information on types and/or strengths of MRI equipment that may have been tested for interaction with the particular implanted device. The radiologist may need to consult with the device implant manufacturer for this information.

Reporting Adverse Events

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event has occurred involving a patient with an implanted device who has undergone an MRI procedure, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events related to MRI and medical devices that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report these events to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.

Getting More Information

If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 301-594-0650 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://list.nih.gov/archives/dev-alert.html.

Sincerely yours,



Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration


Updated May 10, 2005

FDA Public Health Notification: MRI-Caused Injuries in Patients with Implanted Neurological Stimulators

[Bernard]

Shares dipped again in May after the U.S. Senate Finance Committee said it was investigating the FDA's handling of the application. And committee Chairman Chuck Grassley and Ranking Member Max Baucus said late Friday the review would continue.

"The Finance Committee will continue its inquiry into the Food and Drug Administration's consideration of the pre-market approval supplement for the vagus nerve stimulator to be used for depression that is treatment-resistant," they said in a prepared statement. "Both the effectiveness and the safety of medical devices must be ensured prior to their approval by the Food and Drug Administration."

http://www.chron.com/cs/CDA/ssistory...s/3268590.html

Cyberonics began a 200-patient study to see whether VNS could treat depression patients not adequately helped by other therapies. An FDA review last year found no difference after three months of implant treatment. Cyberonics argued that a year later, a significant number of the VNS recipients had had their depression ease.

That yearlong follow-up hadn't been done according to standard scientific procedures — it wasn't a randomized controlled study — and thus critics questioned its validity.

Cyberonics continued to track the VNS recipients, and two years later a third of patients in the original study had experienced some response and between 17% and 20% were in remission, Schultz said, evidence he ultimately found persuasive.

Still, critics have complained that without a comparison group, it's unclear if the implant really helped or the depression eased for some other reason.

http://www.usatoday.com/news/health/...pression_x.htm

[Birdbomb]

For more information regarding VNS


http://www.vnsmessageboard.org

http://www.howdydave.com/vns.html

http://www.vnstherapy.com/default.aspx

[Bernard]

There is an interesting article from the New York Times regarding the VNS and Cyberonic's CEO:

Just about everything about the new device, called the VNS Therapy System, is steeped in controversy. VNS stands for Vagus Nerve Stimulator. The data about its effectiveness is muddy. The U.S. Food and Drug Administration initially declined to approve it for commercial use, then changed its mind and signed off on it in July. It is expensive, about $15,000, and nobody knows whether health insurers will be willing to reimburse depression patients who want to try it. Or whether psychiatrists will support it.

...

More than anyone else, though, it is the analysts covering Cyberonics who bear the brunt of Cummins's wrath. None of them would talk for the record about his antics — they didn't dare. But they all had stories about Cyberonics cutting off their access to the company after a downgrade of the stock, and of Cummins belittling them in private e-mail messages and public conference calls. They also talked about how he wasn't the most reliable imparter of information about the company — "promotional" was a word I heard more than once. Which perhaps helps explain why Arrow decided he had to go to the Sept. 27 event and see it with his own eyes. (Lazard's lawyers, alas, would not let Arrow talk to me for this column.)

...

... Skip Cummins, for all his flaws, is the primary reason Cyberonics exists. When he first stepped in as chief executive in 1995 — he had been with a venture firm that funded the company — it was in desperate straits. He got its first epilepsy device approved by regulators and accepted in the marketplace — despite plenty of resistance. And although it is impossible to know what he did to help change the food and drug agency's mind about the VNS Therapy System, it seems safe to say he left no stone unturned. "I think he probably just planted a tent at the FDA and refused to go away until it reversed itself," said one analyst. He was only half-joking.

http*//www.iht.com/bin/print_ipub.php?file=/articles/2005/10/09/yourmoney/web.1009mjoe.php

[Birdbomb]

What was going on in the minds of those 500 headshrinkers as they watched and listened to the CEO of this company. Those 500 doctors, who are trained to study, recognize and treat abnormal behavor and other mental illnesses must have been having a field day just watching his antics.

The CEO did more to damage to the reputation of the VNS than the devise could ever do on it's own. Here it looks like a madman selling snake oil to the esteemed doctors who treat the most severely ill. What did that do for credibility? I just wonder how many of this doctors would like to have the CEO as their patient rather than a supplier of a needed product.

And just for added fun, here is the next project the CEO is dabbling in. Check out #31
http://www.grandamerican.com/Events/...asp?EventID=91

Makes you wonder excactly WHY they needed that $125 million loan, when the stock prices have almost been cut in 1/2 and not much profit to speak of. Too many question, and sidestepping the answers.

The above comments are my own personal opinions.

[Herb]

VNS Therapy versus the latest antiepileptic drug

Epileptic Disorders. Number 7, volume 1, 22-6, Supplement 1, September 2005, Global care of patients with drug resistant epilepsy

Free Article

Author(s) : Elinor Ben-Menachem, Jacqueline A. French

Summary : Pro anti-epileptic drug: The central issue in medical decision-making is risk-benefit assessment. Surgery of any type is still considered to be a major undertaking. To warrant these risks, the patient has a right to expect that they have a greater chance of a good outcome with an invasive therapy than with a non-invasive one. The main question is when, if ever, this becomes the case when comparing implantation of a VNS Therapy System versus adding an antiepileptic drug (anti-epileptic drug)? After the first drug? The second? After all anti-epileptic drugs have failed? To date, no randomized trial comparing the addition of an anti-epileptic drug against vagus nerve stimulation (VNS Therapy) has been undertaken, although several are currently being contemplated. Without this information, it is more difficult to make a case for early implementation of VNS Therapy. Unfortunately, few data are available regarding the potential for patients to become seizure-free after implantation of a VNS Therapy System. Another issue is side effects. It is important to remember that VNS Therapy also produces adverse events, albeit very different in character than those associated with anti-epileptic drugs, to which physicians have become accustomed. These include cough, dyspnea, pharyngitis, voice alteration and sleep apnea. A less frequently discussed, potentially negative consequence of VNS Therapy relates to the ability to obtain imaging of the patient. Patients who have undergone VNS Therapy System implantation are not candidates for imaging of the chest, breast, or abdomen. A second issue is that imaging of the brain can only be performed with MRI scanners that meet certain requirements, and as MRI technology develops, scanners meeting these requirements may become harder to find. However, to summarize, VNS Therapy is an excellent and useful treatment choice. Fortunately, the choice between anti-epileptic drugs and VNS Therapy is not an “either/or” decision. Each has a role in the treatment of patients with epilepsy, and the advantages and disadvantages of each should be kept in perspective. Pro VNS Therapy: VNS Therapy is no longer a new treatment for patients with refractory epilepsy. The first implant was performed in l988, and since then more than 30,000 patients have received this therapy. It is no longer considered an unusual or dangerous procedure, but it is still used almost exclusively for refractory epilepsy patients and it has not been generally accepted for use as a first line or even second line therapy. However, compared to the new anti-epileptic drugs, VNS Therapy has similar efficacy results in clinical trials and in many epilepsy syndromes and the long-term efficacy results are even more positive, with continued improvement in seizure reduction for up to two years. Two of the major reasons for not using VNS Therapy early are that it is a surgical procedure, and its safety during MRI procedures, especially with 3 Tesla, has not yet been elucidated. The safety profile of VNS Therapy is very favorable\; the side effects being totally different from those seen with anti-epileptic drugs. The most important aspects are that there have been no pharmacological interactions, cognitive or sedative side effects reported, and it is safe for use in all age groups. Side effects are restricted to local irritation, hoarseness, coughing and, in a few cases, swallowing difficulties when the stimulator is on, but these tend to disappear with time. No idiosyncratic side effect has emerged during the 16 years of use. Compliance is guaranteed. The cost of the implantation of the VNS Therapy System, when spread out over 8 years (battery life), is actually less than the cost of using a new anti-epileptic drug over an eight-year period, and real savings as regards hospital costs due to seizures can be expected.

http://www.john-libbey-eurotext.fr/e...1/46/resume.md

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[Herb]

While researching information relating to VNS Therapy for Depression I came across and interesting case report for those females in this readership who might be considering extending one’s family as it relates to VNS Therapy.

The link to the information can be found at:

http://www.annals-general-psychiatry.com/content/4/1/16

Warmly,
Herb

[Herb]

The following is an interesting article for parents of children that are challenged by Epilepsy utilizing the VNS Therapy.

Beneficial effects on sleep of vagus nerve stimulation in children with therapy resistant epilepsy


Warmly,
Herb

[Herb]

Long term effects on epileptiform activity with vagus nerve stimulation in children.

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[Bernard]

Looks like the last two references you posted were by the same authors and both studied 15 kids. Were they the same 15 kids?

[Herb]

Bernard,

Thank you, you’re correct. The same study was presented in two different publications, European Journal of Paediatric Neurology in November 2005 and Seizure in December 2005, with differing text.

Yes, I have read Stacy’s Diary and I feel terrible for her, you and your children. As a support person and health care advocate, like you, I know of your challenges only we had one child and I can only encourage you to remain persistent, supportive and continue your research and education of the illness. From my experiences I would also encourage dialog and sharing with young children to allay them of fears or misunderstandings they may have. As you know I believe these various illnesses are inter-related and dynamic in nature. To date I know of no cures but we most always be vigilant for the unexpected and be prepared with alternative and/or adjunctive treatment approaches to control and stabilize these cycling or outbursts into long-term remission.

In our case we are currently fortunate to have benefited from a treatment regimen that has given my spouse considerable control and stability over an unimagined period of time. It is not perfect but through the “Trial and Error Approach to Wellness” it has, within the majority of the last 6 years, kept her depression free and given us a reasonable quality of life.

I can only extend my best wishes to Stacy and you all for the hope this recent episode will be one you all should not have to experience ever again.

In keeping with good wishes I would like to also extend my best wishes to all the participants of this forum for a very Merry Christmas, Seasons Greetings and a very Healthy, Happy, Prosperous and Peaceful New Year.

Warmly,
Herb

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[Herb]

Dear Bernard,

I also wanted to comment about something you had posted previously which I had read but didn’t have the time to comment upon at that time and then I didn’t remember where I read the posting. Now I’ve located the comment as part of Tracy’s Diary and I would once again like to share what you have stated to your readership as I think it is a very important point to be remembered when treating and addressing one’s illness.

“If you are thinking of the old adage, “If it ain’t broke, don’t fix it” then you are either very wise or have been down this road before.” – Bernard

I wish I could take credit for being wise but the fact is experience and sometimes repeated hard experiences has been an indelible teacher for me.

One doctor formerly attending to Joyce is a professor, researcher, and lecturer and an extensively published researcher used the exact same terminology when he learned after the implanting of her VNS prosthesis that she had previously come out of her depressive cycle. As a little side note if anyone happened to ever read the study data for the original 60 patient D-01 study that the study was labeled “59*.” Joyce was the “*.” Joyce’s prosthesis was never activated during the acute phase of the study as the doctor too firmly believed “If it ain’t broke, don’t fix it” so he decided not to activate her prosthesis.

I have too have learned the hard way to leave well enough alone or “If it ain’t broke, don’t fix it.”

Thanks for sharing a very important piece of medical terminology and/or therapy practice not found in the medical textbooks or research papers.

Warmly,
Herb

[cris]

I have a ten year old son who has had the vns for 4.5 years now. We love it. He has virtually no side effects and we went from calling 911, 4-6 times a week for seizures, to almost none. He still has the focal seizures all the time, but we've learnned to live with those. They say it has a 5 year battery and I can tell that his battery is needing replaced as our atonic seizures are starting up again. (I hope it's just a battery)!

Aside from his routine siezure meds, we were using 15 to 30mg diastat a day and havn't had to use it but a few times in the las 4.5 years. Hope this helps someone else for their seizure control.

[Birdbomb]

Welcome Cris

It's wonderful that the VNS has helped your son. Children seem to reap a better benift than do most adults. I hope it continues to bring him relief.

If the unit reaches EOS (end of service) the entire generator is replaced, not the batteries. The VNS is a sealed unit. It is imposible to replace the batteries. The replacement is not as invasive or as long of a surgery. If you see your son's seizure pattern has changed, it would be advantagious to have his doctor run an interrogation of the unit.

[Bernard]

Hi Chris, welcome to the forum!

It's great to hear that the VNS is offering your son so much relief with virtually no side effects.

[Herb]

Bernard,

Maybe some of your readership might find the following article of interest…

Doctors Believe Stimulator May Work In Younger Children



Warmly,
Herb

[Bernard]

Thanks Herb. That article doesn't provide any clues as to which study they are referring to or when it was done.

[Herb]

Bernard,

I do not know which specific “Federal Drug Administration-approved study tested them in even younger children” that the reporter referred to other than several additional links to information I’ve listed below for your readership to peruse.


http://www.ncbi.nlm.nih.gov/entrez/q...&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/q...&dopt=Abstract

http://www.childrenshospital.org/az/...geS1811P0.html

http://www.epilepsy.com/epilepsy/vns_other.html

http://www.scienceblog.com/community...200113952.html

http://enews.childrenshospital.com/IntheSpotlight.asp

Warmly,
Herb

[Herb]

Bernard,

Your readership may be interested in the following article of possible interest.


Pacemaker may avert epileptic seizures, say US researchers


In addition, here’s some further information pertaining to young children and VNS Therapy as it relates to the previous posting and article:

Vagus nerve stimulation in children less than 5 years old.


Warmly,
Herb