Wednesday, May 18, 2022

Comments by vnstherapy

Showing 3 of 3 comments.

  • @InfiniteJest,

    VNS Therapy for depression is a Wharton text book case in what not to do. This study was steeped in controversy from the get-go.

    I caught up with the former FDA director Dr. Daniel Schultz (Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004 to 2009) some 9 years later and finally was able to ask him despite all the controversy surrounding the therapy what reasons did he have to override the decisions of his underlings and approve the therapy.

    “…treating severe unresponsive depressive disorder is exactly the reason that I approved the device…”

    “When a treatment provides benefit to a small percentage of subjects, it often signifies an inadequate understanding of the condition, the treatment, or both.” — InfiniteJest

    Actually there is a third which is most applicable to the VNS study. That is a poorly designed study. The VNS study was based upon a drug protocol of 12 weeks. Knowing that which we know today Medtronics and St. Jude learned from the VNS fiasco that the study should have been based upon a minimum of 6 months to a year’s study. You are correct that the study results were poor and “not significantly different that sham stimulation.” What you may not be aware of is the fact that one study site had not only a 50% response rate as well as long-term efficacy. What you also might not be aware of those early responders as well as late responders have maintained long-term efficacy as well as recovery unlike anything experienced with medications. From my experiences and knowledge medications often exhibit initial response and efficacy and then refractory results surface over the longer haul for this unique group of patients. On the other hand those that did respond to VNS improved and have maintained long-term efficacy which is unheard of in this group of patients.

    Drs. Wolfe and Laurie of Public Citizen denounced the therapy as nothing more than a placebo effect. That prompted me to request my spouse’s physician to deactivate her prosthesis. He thought I was crazy. Incidentally, I have collaborated through the years with many of the leading KOLs who have been instrumental and helpful with information and suggestions which have helped me to maintain my spouse’s depression free state. I explained to her attending physician that we shall experiment and see whether or not the VNS for my spouse is a placebo. He asked me again, “Are you sure you want to do this?” I explained that it is the only way to know for sure whether this therapy is truly efficacious. Besides, we can easily re-activate her prosthesis. In my spouse’s case she lapsed back into a severe depressive state within a week’s time. The pulse generator was re-activated and within days she was out of her depression and we have not looked back. That experiment was about 14 years ago.
    Patients that have come to me to advocate for their replacement generators have similarly shared stories with me of their lapsing into depression as the batteries in their generators depleted and once able to obtain their replacement they are back to a reasonably good mental state. When I wrote to Drs. Wolfe and Laurie asking them if there is such a thing as a “continuous multiple year placebo effect” I received no response.

    The point being doctors are not deities. There are doctors, good doctors and better doctors. I have been fortunate in obtaining the respect of many of the physicians attending to my spouse as well as those who I have collaborated with through the years that have helped educate, encourage and direct me to help my spouse as well as others.

    Another point I’d also like to make. At the time of the write-in period advocating for CMS to approve the VNS Therapy for the depression indication some 200 psychiatric physicians expressed their reasons the therapy should be approved. One in particular noted that although the response rate was significantly poor one of his patients, the son of a doctor, was one of the worst cases he attended to. Nothing worked. This therapy turned the life of this young man totally around. The point being, the therapy was 100% efficacious for this individual. I repeat 100% efficacious is certainly far better than 17 to 18% response rate. It all depends upon one’s perspective and interpretation of the study results.

    The same holds true for DBS. If the patient is fortunate to respond and obtain efficacy when nothing else has worked a low response rate from a double-blind study is meaningless to that individual. The low response rates are meaningful to the number crunchers sitting behind the computer spreadsheet as well as the health care bureaucracy from the standpoint of money, power and politics.

    Lastly and I really needn’t discuss the fact that I am aware of the controversy surrounding numerous pharmaceutical studies with outstanding results that have been a total sham and yet they have been FDA and CMS approved. Who can one really trust?

  • Danielle,

    I wanted to compliment you on a very encompassing article on DBS.

    Some 50 years ago I coined a phrase, “The Trial and Error Approach to Wellness.” Obviously this phrase is still applicable today.

    As a mental health advocate/activist and support person to my spouse I know what it means to be desperate and the willingness to try any therapy option in the hope of alleviating one’s chronic and severe depression.

    I am truly sorry that DBS did not show better results but there is an interesting point which I am acutely aware of. Like similar poor initial results and findings from VNS Therapy the fact is 17 or so percent of the DBS study subjects did respond and for those individuals the therapy may prove remarkable as nothing else worked for these patients.
    Unlike DBS, VNS Therapy was approved by the FDA but declined by CMS.

    My spouse, an original study subject for VNS Therapy for Depression, has been remarkably depression free for almost 16 years as a result of her VNS Therapy.

    There simply is no way of knowing who will or will not respond to any given therapy without trying.

    Lastly, for any study subjects who have favorably responded to DBS and wish to maintain their therapy should they run into problems with health care coverage be apprised there is a doctrine of “Continuity of Care” which Medicare/Medicaid has on their books and is a lawful policy.

    I have battled HHS/CMS to maintain care for the study subjects and patients implanted with the VNS who wish to continue their therapy. Information that may be beneficial to the DBS patient’s medical coverage may be found on my blogsite(s) listed below.

    I wish good luck and wellness to all those who struggle with MDD.

    [email protected]