What you see is NOT what you get

[willows]

Let's see, I have to make this relevant to Hep C on this board,right?  Well, VX is doing the Prove 3 trials, but ole Doc Scott was right when he told me I would not be one of those folks the trial centers would be rushing out to find.

I have tried three separate facilities and have recieved various forms of NO, in letters, e-mail and phone calls.  Not being much a of quitter, I am still trying, but it would be my cranky opinion that the ole "cherry picking" issue is fairly true when it comes to the trial and especially the arm that includes non-responders.

Doc Scott said they would keep the non-responder arm as small and as controlled as possible and he was sooo right.  As soon as I tell the trial folks I had viral breathru, they didn't want to talk anymore.  

So it is still a cherry pie, because I am okay and positive.  VX is moving right along to FDA approval, and I love cherry pie, will wait a long long time for some.  But it will be a hard pie for those of us who are not typical non-responders (is there such a thing?) and it looks like we have to wait a bit longer.  

If I use a long range perspective, whatever it takes for Vertex to get the drug approved is a good thing.  To become undectable so quickly will help all of us.  But I'm feeling so naive today, I'll get over it, but man, I wanted some cherry pie, I had the vanilla ice cream ready and everything!!

ALL GOOD THINGS COME TO THOSE WHO WAIT....AND WAIT...AND WAIT..

Willow

[prettydamscared]

Looking at doing another 6 months would be very hard to take, especially knowing it may have been avoided. I agree with what you're saying here.  In my case, I knew going in that rescue drugs wouldn't be available for 12 weeks and there would be no individualized therapy during SOC as you described.  I don't like it but know that's the case in a study.  What is so discouraging is that treating doctors many times are uninformed of newer studies and methods.  Granted, they don't have access to allina or oxymatrine but, at the very least, doing pcr's at 4 weeks and using that information to individualize treatment should be standard practice now for anyone treating hep c. LIke willows always says, "I hate this disease".  I hope in a year from now, we'll all have more hope about what to expect from newer treatments.

Char

[prettydamscared]

You said "What I believe is they cherry pick their patients, split them into arms (those poor guys that get the "pits!") and they don't really care about the patient per se, but their stupid trial data."

In my case, I don't feel it's quite that black and white, however, I will say that there is ZERO doubt in my mind that my doctor's main interst and concern is for the study and not me.  Don't mean to be harsh and I'm not upset about it.  Unfortunately, that's the way of the world. I happen to really like my doctor and sometimes wish I could step out of my self and just get him to give me his real opinion as if I weren't in the study.  

Example: and I'll try to make this brief. Before I was unblinded, meaning neither myself nor my doctor knew which group I was in, I was making noises like if I were randomized to the 24 week group, I'd want to extend.  He quoted me the studies that would indicate that 24 weeks would be optimal and mentioned that he'd hate to treat for 48 weeks if it wasn't necessary, he'd almost consider that overtreating.  Of course, needless to say, all that changed when we found out I was in the 48 week group.  I wonder and will always wonder what he would have said about my "29" at 12 weeks, if I'd been randomized to the 24 week group.  Would it have been, it's just a false postiive, there's no way to know, we feel 24 weeks is sufficient which is exactly opposite what he said when we found out I was in the 48 weeks group.  "You have the "29", no way to be sure, better continue on to be safe."  I just wonder and always will.  He's a moral, ethical man but I have no doubt that the good of the study, as long as it's not killling me or anything, comes before the good of the individual patient. It's human nature...we signed up, everybody knows their roles. His is to keep us as healthy as possible while keeping us on the study and in the group we were originally randomized to.

I feel like it's a little hard to get a second opinion too.  All the rock star docs know about the study and probably know each other.  My doc mentioned to me once that at a liver conference this fall, he was approached by a colleague regarding some of my posts on this board.  Can you imagine if I went to see a colleague of his?  Would that colleague have my best interest at heart or be reporting back to my doctor that his study patient is out getting second opinions.  I'm kinda over dramatizing there but I am a little concerned about that aspect of getting a second opionion from a top doc while I'm still in the study.  I think they might find it unethical.  There's a lot of peripheral information that's important to know about being in a study that you would never think about beforehand.

Sorry if I seem synical because I'm really not.  I'm truly appreciative of the opportunity that I've been offered....I'm just not seeing it all through rose colored glasses anymore.

[sfbaygirl]

I understand you are grateful for this opportunity to tx in a trial and thank goodness you werent in the arm of mono therapy. I guess I am more cynical than you are in this respect. I know I would feel as you if I were given the opportunity to tx in vertex and were unblinded in the "good arm". I think why I am so bothered is because it isnt the new trisls but the ones those of us that are on SOC with INF/Riba that are now blessed with this tx that has passed the muster of the FDA. Perhaps if "I" were given 4 week PCR's, double dose INF at the beginning, extra antivirals like Allina or Oxymatrine, rescue drugs instead of reducing tx, etc. I wouldn't be so cynical of how the trials turn into SOC eventually. They know that there are better ways, new studies come along and are ignored by dr's. They have to! They can't go against what the FDA approved as SOC. As HR says, you have to have a family member prescribe a different tx other than the protocol. We need studies, I am just a LOT cynical right now looking at an extra six months when this may have been avoided with more sensitive and early tests.

[Kalio1]

Trials are all voluntary, they can cherry pick or do whatever they deem necessary to collect data how ever they want. It isn't like they aren't up front about it, there is a big risk to participating in OR waiting on treatment in the hopes of getting in a trial on many levels. They will pick people for whatever reasons they deem appropriate. If I owned the company I'd want to pick the participants I felt would do well so my success rate was as high as possible.
I do feel they should offer any participant in the placebo arms an opportunity to tx once the trial has concluded, that would be a good thing to ask about prior to signing up. I'd check it out thoroughly before I signed up. I don't think people can really begrudge the people running the trials the right to run the trial in whichever way they see fit, these are private companies.

[prettydamscared]

I'm so sorry you're experiencing what appears to be "cherry picking"  As I said before, I truly don't believe that was done in Proof 1 or why would they have taken Pam with a Stage 3 liver and extremely low hg to start.  Why would they have taken myself and APK with 27 & 28 million, respectively, all factors that contribute unfortunately to lack of svr.

I have no idea how they're choosing patients for Prove 3 but it sounds like you're having pretty bad luck with it so far.  I'm inclined to agree with Jim.  You may just have to wait your turn, and wait and wait. If anybody deserves to get in, you do.  I'm not even gonna tell you to not give up cuz I know that ain't happening.

Have a good weekend.

Charlotte

[chcnme]

Hi Willow.  Yep, the wait and wait and wait game.

Here is an excerpt from the The AASLD Treatment Guidelines.

"Current recommendations for treatment of persons with chronic hepatitis C are derived from data gathered in the randomized, controlled registration trials previously described. Persons who entered these trials, however, were carefully selected so as to exclude those with conditions that might potentially compromise treatment response."

I agree - it's "cherry picking".  For those of us who have to wait and wait and wait, I guess we can only hope they pick the BEST cherries and that we'll be good cherries by the time we can eat from that cherry bowl :)  

Hang in there.  VX is bound to be launching a study soon for relapsers specifically.  (I think the PROVE3 is for "nonresponders".)