Tuesday, March 21, 2006

Pacemaker for Depression: But Does it Work?

Eight months ago the Food and Drug Administration (FDA) approved a pocket-watch-sized device billed as "a pacemaker for the brain," the newest cutting-edge treatment for as many as 4 million adults whose severe depression is not relieved by psychotherapy, drugs or even shock treatments.

Since then, more than 550 Americans have undergone surgery to have a vagus nerve stimulator (VNS) implanted in their chests to activate parts of their brains. However, the only rigorous clinical trial of the device -- which is approved to treat severe epilepsy -- failed to demonstrate effectiveness in alleviating depression.

What happened to evidence-based medicine?


Sue Trinidad said...

Your question seems especially apt given that FDA has also acted against scientific evidence in the other direction--ie, the refusal to license Plan B for OTC sales.

And. . . given that women are twice as likely to experience depression during thier lives (compared with men), this is an important issue for women's health.

lifetime said...

Dear Linda,

I find it fascinating as I’ve hit upon a number of blog sites of individuals passing judgments and opinions based upon Ms. Boodman’s article which I personally have some insight into. One of the points I shall make, knowing a number of individuals interviewed, that she was prodding only for negative information.

Obviously you along with a number of individuals lack a great deal of knowledge as well as background relating to the VNS treatment option and I might guess also understanding TRD (Treatment Resistant Depression). My qualifications to speak on this subject matter is the fact that I am a very long-time support person, health care advocate to my spouse and her depression lay-expert of almost 43 years as well as an activist, former President, Board Member and Facilitator of a local chapter of the DBSA as well as a state appointment as a Guardian Advocate. In addition to my years of experiences I am an active researcher and knowledgeable in matters relating to depression. Along with a number of other hats I’ve worn through my life time I can tell you that MDD (Major Depressive Disorder) is a life threatening illness and those individuals who participated in the VNS studies were “the worst of the worst.” These same individuals are normally rejected from drug and alternative study programs. So while you interpret the article to indicate that the therapy “failed to demonstrate effectiveness in alleviating depression” what you and many others have not followed is whether the therapy failed or the study was a failure.

As it turns out the study was the failure for a number of reasons and not the therapy. Long-term study results subsequent to the one study failure indicate long-term efficacy and remissions not seen in drug therapy studies. Whereas drugs work in the short-term and lose efficacy or “peter out” this therapy apparently is demonstrating efficacy and longer term remissions.

“What happened to evidence-based medicine?” That in fact is one of the problems creating the failure of the study. The VNS Therapy is a device and not a drug. The study was based on a drug protocol and was a serious mistake from the start. The FDA regulations governing drugs and devices are different and that was another of the study mistakes.

In any event and of the utmost importance, my spouse has been almost continuously depression free for the past 6 years utilizing the VNS Therapy and there are many other individuals also obtaining similar efficacy and a QOL (Quality of Life) they have not experienced in many years. The evidence is in the faces of those patients benefiting from the therapy and not the biased attempts on the part of the reporter.



Linda MacDonald Glenn said...

Thanks for the personal insight, Herb -- I wonder would have compelled the reporter to give such a biased slant? Just a lack of understanding?