You're not going to believe this !!!!

[brmoore]

    As a pre-dialysis patient I was asked if I would like to volunteer for a study being conducted by the Neph. Dept. on a new product. Always willing to help I thought - Why Not. Having worked for many years as a pharmacutical rep. I had enough sense to look over the protocol with care. I ran into two paragraphs that really caught my attention.
    After stating that there could be serious side effects (although rare), it states That I (or my insurance comp) would be responsible for paying for any drugs or treatment that result from side effects. It also states that if I am hurt in any way as a result of this study I will not receive any compensation for lost wages, disability or discomfort. In other words this company is asking for a free ride if their product causes me any injury.
    Sort of reminds me of the Country (can't remember which one) that shoots the prisoner, and then make his family pay for the bullet.
    I did ask Doctor in charge of study if I was correct in my understanding of these points and he said yes. I, of course, said no to the study. Having failing Kidneys does not mean that I have a failing mind.
                                                                                                                                    Bruce

[paul.karen]

Hey bruce
Yeah that is scary for sure.  I would have said no as well.

But a question for you.  What was the new product?  Pill, machine, portable in center out center???

[boxman55]

Anybody in there right mind would have to be nuts to agree to such terms. Is this standard for any trials, or are they all differant?  Boxman

[brmoore]

Hi:
   I did not identify product or company producing it for my own legal protection. I can say that it is a product looking for approval for use in Vascular surgery.
                                                                                  Bruce

[Lucinda]

They do anything!  My vascular surgeon did not even tell me he was using a trial new graft material on me and just went ahead and used it.  It failed three times before he told me what he had done and they gave me the old version - which has worked perfectly.  I went through three surgeries and it cost me over $3,000 to pay for their mistake.  At least they asked you and then told you the downside.  They didn't give me the option! 

[paddbear0000]

They're going on the assumption that most people do not fully read the materials they give you. That's how they get their guinea pigs.

[brmoore]

Hi Lucinda:
    Now that's a real horror story. The fact that it was a trial means it did not yet have approval , and could not be used without your approval. Did you do anything to try and recoup the #3,000 that it cost you  ??
    To often we are afraid to confront our caregivers out of fear it will impact us in a negative way.
                                                                                                       
                                                                                                               Bruce

[Lucinda]

I didn't bother in the end Bruce.  I was just pleased to get the right one in and have it work.  I found out from one of the techs after they put the old type in that the previous ones had been the new trial version.  Bit late to do anything about it.  Surprisingly, since it was used on me, they have given it the OK.  Hope noone else has to go through the same issues as I did!  I wrote a letter the the medical association and they have it on file now if anyone else has a problem with the same graft material.  I also sent a letter to all the vascular surgeons in Australia and told them of my problem so they would think twice before using it.  Not much more I could do.