I'm reposting his comment followed by mine. Note that any highlighting is added by myself...
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:
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:
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.
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.