Friday, December 08, 2006

New York Says No to VNS

I noticed someone was looking under "medicare determination VNS" and stumbled upon my site. I did a little (and I mean very little, sorry) research on the topic. I noticed that Public Citizen recommends (wisely) that vagus nerve stimulation not be covered by Medicare as a depression treatment due to the meager evidence in its support. I suspect that Dr. Charles Nemeroff disagrees.

I could not find any national Medicare policy on VNS, but I found that the state of New York had the following to say: "In 2005, the FDA approved this device for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. However, based on review of the available scientific literature and other pertinent sources, this Local Coverage Determination (LCD) finds there is not sufficient evidence or support to pay for VNS therapy as reasonable and necessary treatment for depression."


With this sort of evidence based decision making, I have to say "I [HEART]
New York"

5 comments:

Herb said...

I happened upon your blog and I’d like to take a moment to share my perspective as it relates to several of your postings relating to the VNS Therapy for TRD. Unlike you I do not hold any academic degrees in Psychology or Psychiatry but I do have hands on experiences, research and knowledge of 43 years as a support person to my spouse and as a mental health advocate and activist. Amongst the many hats I’ve worn through the years I’m a retired business executive and entrepreneur as well as a former DBSA (Depression Bipolar Support Alliance) facilitator, President and Board Member of a local chapter and a state appointment as a Guardian Advocate.

While you may be “an academic with a respectable amount of clinical experience and no drug industry funding” you don’t indicate if you’re an M.D. or PhD. nor do you elaborate on what a “respectable amount of clinical experience” represents or the fact that you receive no drug funding. Is the fact you receive no drug funding a shortcoming and/or reflection upon your lack of expertise or abilities? There’s something to making innuendos when reading from a couple of lines of text without really researching and digging deep as I’ve found from some of your commentary. The fact that researchers and other medical professionals receive funding from sponsors is not an indictment of their research, ethics, integrity or honesty or in the case of Dr. Nemeroff an admission of guilt that his research is incorrect or that his peers think any the less of the man’s work. It certainly is an impropriety and rightfully cited but is not necessarily a cause for indictment as to the information. Nor do you explain to your readership the nature of funding for research and without sponsor funding most research would be non-existent.

I shall also add to the other hats that I’ve worn I am also intimately involved in researching the VNS Therapy for TRD simply because my spouse was one of the earliest research study subjects for this treatment option. Unlike you reading the Public Citizen and the comments of Drs. Lurie and Wolfe, both of whom are not trained in the field of Psychology or Psychiatry and both questioning the safety and efficacy when in fact the therapy has safely been used for over 10 years and longer-term study results (2 years) are establishing long-term remissions and efficacy for TRD when compared to the failures of other treatment options for this extremely difficult to treat and disenfranchised group of patients. I also wrote to Dr. Lurie regarding his assertions of a “placebo effect.” I asked him to please cite for me any medical literature relating to a “placebo effect” lasting 3 or more years which many of these patients are experiencing contrary to Public Citizen’s letter(s). I still have not received a response from him. Maybe you’d care to respond as you seem impressed with their writings?

Obviously you’ve not read nor have you commented upon the 300 or more medical professionals and leading researchers, who also take exception to many of your comments, some of whom have correctly divulged their relationships to the sponsor. Then too, so has the membership (about 36,000) of the APA having no relationship to the sponsor responded contradicting your position which you’ve omitted from your commentaries to your readership.

The facts are the D-02 (double-blind study) was an acknowledged blunder from the standpoint of the protocol being based upon the protocols of drug studies but then again I’m sure you had an understanding of that fact. This is a medical device and not a drug and the requirements are different. You also omitted in your commentaries that the independent device panel of experts favorably approved the therapy too. While you seem to arrive at the conclusion that the study was a failure it appears many of your colleagues do not see it as such but as I’ve previously stated you haven’t read their commentaries as it is not apart of the news media’s sensationalistic forms of reporting that you appear to be reading without getting to the nitty-gritty of the story.

I happen to have a website which I utilize as a repository of information that I’ve garnered through the years and a means to share my unbiased thoughts and information relating to the therapy. It is called VNSdepression.com.

The link to the site is:

http://www.vnsdepression.com

More importantly from a real-life and real-time standpoint after 37 years of failed psychotherapy, medications, holistic approaches and other alternative as well as adjunctive therapies my spouse has achieved almost 6 years of continuous remission with little or no medications. Then too so are many others who have had similar experiences to my spouse.

While the therapy is not a panacea it does afford a new an innovative approach to a percentage of the most difficult patients to treat with varying degrees of efficacy not obtainable elsewhere and therefore the need for this therapy and the continued research into other new an innovative approaches to treat this unique population of patients.

I’ll add that my spouse’s psychiatrist maintained an attitude similar to yours as it pertained to the initial data but he was willing to listen and be educated. Of his clinical patient load he now has about 14 patients who were some of the worst of the worst now experiencing varying degrees of wellness not achievable through other means. His opinions have changed and this therapy affords him an additional tool to help his patients. This same clinical fact is also being observed and shared by other physicians.

Maybe to help you along in your academics and research on this subject matter is a compilation I’ve made of the comments from other professionals which you can find at the below listed link:

http://www.vnsdepression.com/p7-00_lettersfromthemedicalprofessional.htm

So while I maintain there are doctors, good doctors and better doctors so too do I maintain that when a physician hangs out their shingle to practice it doesn’t indicate if they graduated first or last in the class or if they read headline news articles or seriously delve into the subject matter.

I thank you for this opportunity to share with you and your readership what is in this instance an opposing viewpoint. I am a very vocal advocate for all treatment options that may help this unique and seriously ill population of patients including the oft maligned therapy of ECT. I have known as a support person the desperation of having little or no choice and the pain and anguish of my spouse to end her suffering on eight separate occasions. Today she is depression free, has a reasonable quality of life and looks at life from a much happier perspective regardless of situational stresses and/or trauma.

Warmly,
Herb Stein
VNSdepression.com


.

CL Psych said...

Herb,

I’ll respond to your points here – please let me know if I miss anything.

*First, I have a Ph.D., not an M.D. However, the letters after one’s name are not the most relevant marker of one’s expertise, as someone with a lesser education than I, with proper training and education, could certainly know as much or more than myself.

*I have seen many clients suffering from a variety of conditions. There are many, many practitioners with much more clinical experience than myself. You’ll note that in my posts, I typically allude to research, not relying on my clinical experience. One’s clinical experience can prove virtually any point, which is one major reason why research is conducted.

*I find it ironic that you end your post with “warmly” while asking me “Is the fact you receive no drug funding a shortcoming and/or reflection upon your lack of expertise or abilities?” Herb, that ain’t so warm. In any case, I’ll leave it up to my readers to register their opinions regarding my expertise or abilities. I can tell you that I have published several articles in peer-reviewed journals and continue to perform research; personally, I think I’m a pretty good researcher. I am just stating that I have no conflicting financial interests that could potentially impact my work.

*Receiving industry funding is not, in itself, a sign of poor integrity or ethics. Failing to report conflicts of interest, however, is an issue.

*Without industry funding, most drug research would not be conducted. There, I said it. I’ve argued on numerous occasions that “research” is often meaningless – see my posts on the ARISE-RD Risperdal (here) study or another on mifepristone (here) for an example. Due to biased measurement, unrealistic dosages, failure to fully disclose data (suppressing negative findings), biased interpretation of the results (putting a very positive spin on dubious findings), etc. – a lot of so-called research makes for great marketing copy yet often shows few if any advantages for a product over existing (and cheaper) products, or, in many cases, little or no superiority over a placebo.

*Lurie and Wolfe may not be trained in psychology or psychiatry. That is not very relevant. If they can interpret research findings (as it appears they can), their lack of clinical expertise in these areas is not relevant. Similarly, I can look at data on Vioxx and say “Wow, that drug sure killed a lot of people” without being a cardiologist because I can interpret the research.

*As for VNS 2-year outcomes, I tracked down the linked abstract from the Journal of Clinical Psychiatry. Among individuals who showed an initial response to VNS therapy, 22% had a remission of depressive symptoms at 2-year follow-up. I am not impressed.

*What would impress me are solid data from trials in which VNS therapy showed clear superiority to fake-VNS therapy (aka sham VNS therapy). If you have such data to share, please share your reference.

*You cite letters from doctors and (I think) an endorsement from the American Psychiatric Association. I’m not sure about how APA’s 36,000 members tie into this. I don’t believe APA officially endorsed the treatment. You indeed have posts from various physicians on your site. These are a selected sample of individuals who testify to positive experiences. When faced with choosing between clinical opinion and research data, I fall on the side of research

*I am happy to hear that your wife has shown significant improvement in her depression. That is always good news!

*Please feel free to respond if you would like. I am glad that you have taken the time to become involved in this issue.

Herb said...

Dear Doc,

Thank you, I shall take you up on your offer to respectfully respond.

I would like to state that my intention was not to offend you by my remarks pertaining to the fact that you receive no drug funding as I understood your intentions but it was an attempt on my part to take your words as written to sensationalize or distort and/or make innuendos as I found in some of your commentary and that relating to the Dr. Nemeroff such as “pimp” and other sensationalistic news media reporting relating to the VNS Therapy for TRD that I come upon. If we’re going to discuss the therapy let’s stick to the therapy and not make innuendos or imply as you’ve also attempted relating to the finances, the management of the company and/or the researchers in order to taint the therapy.

I may differ with you upon your opinions on subject matter but “warmly” stands as my respectful salutation to you and others as individuals.


“…the most relevant marker of one’s expertise, as someone with a lesser education than I, with proper training and education, could certainly know as much or more than myself.”


I am in agreement with your statement. 43 years of empirical observations of my spouse’s illness and numerous therapies as well as my own research and collaborations with the experts in the field qualifies me, in my own mind, as a depression lay-expert to my wife. No one knows better than me what has or has not worked in terms of her treatments and therapies and the fact her illness’s origin is a genetic bio-neurochemical malfunctioning in her brain not caused by or affected by parental upbringing or situational or traumatic events in her life.

While I have only read your posts relating to the VNS Therapy I acknowledge your statement “I typically allude to research, not relying on my clinical experience” except for the fact it is often clinical experiences and/or empirical observations that in my opinion lead to discoveries and prompting research. It was the clinical observations of the neurologists and other physicians attending to their epilepsy patients that lead to the study of this therapy for depression.

Okay, we both agree that there is a need for sponsorship funding and improprieties do exist.

I disagree with you as to Drs. Lurie and Wolfe’s lack of training in this field is very relevant just as I would interpret and put little value in your ability to “interpret research findings” in techniques for brain surgery or the interpretation of the readings of MRI or other scans etc. The more I read the research data and opinions of the data from the professionals the more I see conflicting opinions taking place. I read one side supplying data that ECT is harmful and damaging to the brain and the other side reads the same data and presents their own findings that no such events take place and in fact I further read the research of Dr. Yvette Sheline indicating that ECT stimulates neurogenesis. Now I’m only a depression lay-expert to my spouse looking for answers from professionals like yourself and I find you professionals in conflict over the exact same information which leads me to the following points.


“Based on last observation carried forward analyses, HAM-D-28 response rates were 31% (18/59) after 3 months, 44% (26/59) after 1 year, and 42% (25/59) after 2 years of adjunctive VNS. Remission rates were 15% (9/59) at 3 months, 27% (16/59) at 1 year, and 22% (13/59) at 2 years. By 2 years, 2 deaths (unrelated to VNS) had occurred, 4 participants had withdrawn from the study, and 81% (48/59) were still receiving VNS. Longer-term VNS was generally well tolerated. CONCLUSION: These results suggest that patients with chronic or recurrent, treatment-resistant depression may show long-term benefit when treated with VNS.”


Here is a part of the same abstract we both read and yet, you the professional and I the depression lay-expert to my spouse strongly differ. Since I am not aware nor have you indicated the nature of the population of patients you attend to I’ll share with you that my spouse and those who attended our support groups and those who I currently collaborate with are what I would refer to as “the worst of the worst patients” suffering from treatment resistant depression. These are patients suffering the illness for 10, 20, and 30 or like my spouse, almost 40 years. These are patients with multiple yearly hospitalizations costing health insurance organizations and our government (Medicare) in the hundreds of thousands of dollars per patient each year. These are patients who have tried not one, two or three medications but have often been treated with 20 or more medications individually and/or in combination as well as other alternative and adjunctive therapies. These are patients who in desperation resort to ECT which has its own history of efficacy, side-effects and conflicts. These are patients who in many instances resort to the last resort to relieve their pain and anguish through single or multiple suicide attempts. So this is the unique population of severely ill and disenfranchised patients who cannot even advocate for oneself of whom I speak that have not obtained any efficacy let alone any thoughts of long-term remission.

So while you are “not impressed” with the data of “22% had a remission of depressive symptoms at 2-year follow” I’ll give you my interpretation and suggest you go back and read all of your colleagues comments and those who presented the “con” thoughts which I also unbiasedly included but you didn’t read.

Did you notice the response rate from 3 months to 1 year increasing and essentially holding at 2 years?

Did you know this response is unheard of for medications and most other therapies for this patient population?

Did you not notice the remission rates at 3 months to 1 year increasing and essentially holding at 2 years?

Did you know this remission is unheard of for medications and most other therapies for this patient population?

Are you not also aware this population of serious ill patients is excluded from drug studies?

The VNS Therapy for TRD study took “the worst of the worst” patient population.

May I also point out to you that a true double-blind study of this medical device cannot ethically be performed and if so the patients who are not the sham subjects would know almost immediately and be cognizant of the fact they are obtaining the therapy?

While you are “not impressed” I like many of those professionals commenting to CMS recognize the remarkable events and data being presented. A significant percentage of the most difficult patient population unresponsive to multiple treatments options over decades of trying are for the first time obtaining varying degrees of efficacious responses and more significantly as the therapy remains active 24/7/365 requiring no patient compliance (which is another serious issue in the treatment of patients) are obtaining and maintaining longer-term remissions, safely.

By the way something also not unheard of in medicine is the crossover use of medications for one illness to be used for another is essentially what is being done with this therapy.

What impresses me is the solid real-time efficacy being obtained by patients who otherwise would have just about given up.


“*You cite letters from doctors and (I think) an endorsement from the American Psychiatric Association. I’m not sure about how APA’s 36,000 members tie into this. I don’t believe APA officially endorsed the treatment.”


I cited my link for you to read the responses from some of the professionals. Included in that link and highlighted in yellow is the response of the APA and its 36,000 or so members unaffiliated with the sponsor.

The APA officially endorses the treatment contrary to your belief!

I would also like to offer up for you and your readership my screen capture of the entire response to CMS (Medicare – National) so that your readership may have an even clearer picture of this therapy option and in turn make their determination.

http://www.vnsdepression.com/pp10-804-articles_8-10-06-Medicare-Coverage-Database-5-07PM.htm

Let us not forget the field of Psychiatry as a whole. It is an art or practice trying to become a science. It is a field using a book, DSM IV, which in my mind is anything but scientific describing symptomology and assigning terminology without any diagnostic and/or quantitative means via blood tests, x-rays, MRI etc to establish the validity of any of the diagnosis that your profession assigns and/or labels patients and yet here we are debating the research data of illnesses not scientifically established. Lastly, many if not most of the research documents I read as it pertains to Psychiatric research are nothing more than theorizes.

Once again, I appreciate your thoughts and opinions and this opportunity to freely discuss what I personally think is another viable and safe treatment option to be considered through education by the patient and his/her support persons and then to make an informed and un-coerced medical decision in collaboration with one’s trusted, compassionate, knowledgeable and licensed health care professional.

Warmly,
Herb
VNSdepression.com


.

Anonymous said...

I realize this is an old post but I felt I should let others know Mr. Stein holds stock in Cyberonics. I guess had he disclosed this others might have reason to discredit him.

Anyone can do a Heb Stein VNS google search and come up with some interesting information.

Anonymous said...

Cybernics is the makers if VNS devices.