You all might find this interesting.......
The University of Texas Health Science Center (UTHSC) at San Antonio is currently recruting depression study participants for VNS. I called the nurse who was listed as contact. I asked some questions and got some awful answers. I asked about exclusions. She said the person enrolling in the study can not be in current psychosis and has had to have tried 4 different anti-depressants that are not working in the last 6 months. I was ok with that answer. What I found awful was I specifically asked about health history exclusions. She asked such as, so I said breathing problems like asthma. She said (her exact words now- too bad for her I had pen and paper while she was yammering away) "That shouldn't be a problem" and there are "No other health history exclusions". :fear: I asked who pays for the implant, she said they do, then after 6 months, you go see a VNS Psychiatrist who does the adjustments and my insurance would have to pay for it. Then I said what if it doesn't work, she said "That's a chance you take". I then said what happens then, she said the VNS can be adjusted or I can leave it in or have it taken out but they won't pay to have it taken out. She offered no information about side effects, adverse events, if the coils can be removed, etc. She said nothing about Medicare or other insurance companies not covering VNS for depression.
I am curious where other studies are going on. I know when the U of Michigan was doing recruitment, there were health history exclusions, and they made it clear on their website.
:wallbash: It is pretty obvious these people just don't learn. This is sad.
Dispatch B)
Hey Dispatch,
I may just call for the fun of it...ask the same questions you did. Then tell the person I'm talking to that they better read the physician's manual or they may end up killing innocent people.
Why in the heck is anyone still "testing" when supposedly CYBX is not even training anyone to handle VNS patients any more? These poor innocents who are subjecting themselves to long-term challenges and BIG TIME PAYMENTS are in for a shocking wake up if in only 6 months they become totally responsible for themselves.
OMG!!!!!!!!!!!!!!!!!!!!
Good questions Oreo. I am understanding they are doing this study to find out which settings are best. Go figure because each person responds differently. This study is being done as a back door method to submit to CMS the efficacy of VNS, and again safety has been dismissed.
Dispatch B)
Ten must-ask questions about joining a clinical trial
| QUOTE ("Neurology Now") |
... What are the benefits for trial enrollees? Participants receive cutting-edge treatments, typically at no or reduced cost. “It gives them options beyond the regular standard of care,” says Joanne Lord, L.P.N., a certified clinical research coordinator at the University of Michigan.
...
But participating in clinical trials is not without risks, and there are a few questions every patient should ask before signing on. All prospective participants for a trial should receive an informed consent document. Read it carefully, as it spells out the details of the study in simple language. |
The ten questions (read the article for more details about the questions):
- What is the end point of the trial?
- Who is running the trial, and what are their credentials?
- What are the risks and possible side effects of the experimental therapy?
- How long will I be participating, and can I stop if I change my mind?
- What are the chances I will receive the active treatment rather than a placebo or alternate treatment?
- What is required of me?
- Is there any cost to me?
- What happens if I encounter a problem during the study?
- How will my participation affect my current treatment?
- How will my medical data be handled?
Put to the Test (.PDF file)
:Yeah That: GOOD QUESTIONS!!!!
Dispatch B)