Wednesday, May 25, 2022

Comments by adversedbs

Showing 2 of 2 comments.

  • Hi James,

    I appreciate the fact for someone who has TRD, there is no light at the end of the tunnel and DBS would be seen as appealing. Problem is that the device manufacturers are attempting to go to market far too soon and at the cost of hundreds of sufferers who become their guinea pigs and with limited rights. Additionally, the lack of support when something does go wrong is what differs that from the proceedures you mentioned in your post.
    The fact is that DBS for TRD is plagued with problems and has been for many years. SJM continue to “hide” around the facts of their clinical trials which they have been supporting. Why not share the results openly…and now…..rather then simply saying that they are coming.
    Informed consent is a wonderful thing; when you are fully informed. Unfortunately medical companies fail to fully inform potential patients about what can go wrong. Medical ethics would dictate that a patient has all the facts prior to agreeing to a proceedure which is not proven and is still very much in the experimental phase. I agree it is down to individual choice, and appreciate the aspect of there being the element of desperation. Full disclosure however and honesty is required from the manufacturers and medical professionals who continue to “push” certain options.

  • The problem with the likes of DBS for TRD is that it is really unregulated. Yes the FDA provides initial approval but when the trial is cancelled by the FDA they will not and cannot disclose the exact reasons due to it being a “clinical trial” and as such, the information from the likes of SJM is legally and commercially privileged and not able to be disclosed.

    The way in which this trial was run in my opinion borders on medical malpractice. I would love to hear from everyone who went through the trial and had adverse side effects.

    The article written by Danielle Egan is excellent but only the tip of the iceberg. Medical companies such as SJM and Medtronic need to be held accountable for the misinformation and damage caused ongoing to people who are not able to provide informed consent.