Ethical Imbroglio Faces Cyberonics Regarding Neuropsychopharmacology Article
In medical school, I thought it was fascinating that electroconvulsive therapy (ECT) was useful in severe depression which was resistant to other treatments. Those memories resurfaced as I was prompted by a recent Wall Street Journal article to read an article in the journal Neuropsychopharmacology which described research showing a vagus nerve stimulator (VNS) having similar promise in treatment-resistant depression.
Who would know what would be disclosed, that every author had an undisclosed financial relationship with the... device manufacturer, Cyberonics:
Ronnie Wilkins, the executive director of the medical society that publishes Neuropsychopharmacology, says that the consulting arrangements should have been disclosed and that a correction will be published as soon as possible. He says the authors did report their financial relationships with the company in forms they are required to fill out as part of the publication process. However, he says the consulting information was not included in the manuscript of the review piece as required.
It will be interesting to see what the fallout is regarding the editor of that journal having also been an author of the article in dispute. Cyberonics tries to show it had no influence by granting an unrestricted grant to undertake the research. But the article should have clearly stated the financial arrangements -- curious how that escaped publication.
Electroconvulsive therapy has long been practiced as effective treatment for severe depression and psychotic depression. According to the Nature paper, in 2001 the FDA approved VNS as an alternative to electroconvulsive therapy which lacked evidence of long-term benefit and side effects. Since then, a limited number of patients have been studied, not many more than those reviewed by the Technology Evaluation Center of the Blue Cross Blue Shield Association in August 2005 (TEC).
At that time, the TEC stated that the "available evidence is not sufficient to permit conclusions of the effect of VNS therapy on health outcomes." Specific concerns included the study's definition of treatment-resistant depression and the lack of statistical significance of the results. Some providers define treatment-resistant depression as patients having failed to improve after 6 weeks of therapy on 2 medications, but others allow for a total of 10 to 12 weeks [1]. By defining it with this shorter duration, possibly less severely affected patients were included in the trial. What a lack of statistical significance means is that by the study's numbers you can't be sure that this treatment helped.
Sounds like ECT will continue to be used in severe depression for some time, until these ethical quandries are cleared up and more studies are done.
References:
1. Nemeroff CB. Augmentation strategies in patients with refractory depression. Depress Anxiety 1996-97;4:169-81
Who would know what would be disclosed, that every author had an undisclosed financial relationship with the... device manufacturer, Cyberonics:
Ronnie Wilkins, the executive director of the medical society that publishes Neuropsychopharmacology, says that the consulting arrangements should have been disclosed and that a correction will be published as soon as possible. He says the authors did report their financial relationships with the company in forms they are required to fill out as part of the publication process. However, he says the consulting information was not included in the manuscript of the review piece as required.
It will be interesting to see what the fallout is regarding the editor of that journal having also been an author of the article in dispute. Cyberonics tries to show it had no influence by granting an unrestricted grant to undertake the research. But the article should have clearly stated the financial arrangements -- curious how that escaped publication.
Electroconvulsive therapy has long been practiced as effective treatment for severe depression and psychotic depression. According to the Nature paper, in 2001 the FDA approved VNS as an alternative to electroconvulsive therapy which lacked evidence of long-term benefit and side effects. Since then, a limited number of patients have been studied, not many more than those reviewed by the Technology Evaluation Center of the Blue Cross Blue Shield Association in August 2005 (TEC).
At that time, the TEC stated that the "available evidence is not sufficient to permit conclusions of the effect of VNS therapy on health outcomes." Specific concerns included the study's definition of treatment-resistant depression and the lack of statistical significance of the results. Some providers define treatment-resistant depression as patients having failed to improve after 6 weeks of therapy on 2 medications, but others allow for a total of 10 to 12 weeks [1]. By defining it with this shorter duration, possibly less severely affected patients were included in the trial. What a lack of statistical significance means is that by the study's numbers you can't be sure that this treatment helped.
Sounds like ECT will continue to be used in severe depression for some time, until these ethical quandries are cleared up and more studies are done.
References:
1. Nemeroff CB. Augmentation strategies in patients with refractory depression. Depress Anxiety 1996-97;4:169-81