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

[ChrisDDD]

P.S.  "Sock" of the whole f**king thing?  Well, obviously that should be sick of the whole f**king thing!  Proofread before post?  Bah!  Why bother?

I've decided I've allowed HepC to completely dominate my life.  No more.  I'm going on with my plans and put treatment on the back burner.  Willows, at least you've been told no because of relapse.  My situation involves a risk on Vertex's part that I could lose my sight?

My husband put it best.  He said that eventually Vertex and doctors are going to have to talk about the 900-pound gorilla sitting in the room that = the retinal issues people are having with interferon that is seldom mentioned, though it's enough of an issue that most docs are now requiring baseline retinal screening pre-treatment.  I agree with him, but until VX-950 gets FDA approval, I may not get to try it.  I agree with another poster here that it would seem unethical for Vertex to run a trial for non-responders and use a placebo for any arm of the study, and that the FDA would likely not allow this.  My husband also said that at some point the doctors and drug companies are going to have to admit and deal with the fact that many people are now becoming sick from this disease and that SOC usually doesn't work!!  At least not for me!  The posts I read from re-lapsers are devastating.  And I'm not proof-reading this one either before I hit "Submit Comment".  F**k it!

[ChrisDDD]

I agree with all of you, and feel particularly for Willows.  I felt that I was led to believe by this very excellent doctor and research hepatologist that I was a perfect candidate for PROVE 3 in being a non-responder to all three previous treatments I was in.  Then when I call to get an update from the study nurse, I'm told that my history of retinal bleeding on Infergen may exclude me from PROVE 3?  The doctor says Vertex makes the decision who gets in and Vertex says the doctor makes the decision who gets in, so somebody's full of ****!

My life has been on hold since January of '06 and I have planned my life around this stupid disease and treatment.  I got married two years before I'd planned to because I didn't want to be bald in my wedding photos.  My new husband and I were also concerned that he have legal rights for me if I were to be incapacitated for any reason.  I'm not sorry we went ahead and got married, but I only lasted 9 weeks on Infergen before the stupid retinal bleeding was found and treatment was stopped.

PROVE 3, I was told, was going to start in September of last year.  Since I didn't really start feeling good until then, my doc and I agreed that I would remain on long-term disability, which began when my treatment did and continues.  My disability payment barely covers my health insurance premium, so my monthly income is $250 per month, yet I feel too ill (mostly fatigue and brain fog) to work at the job I was at.

I saw my doc in December of '06 believing I'd begin pre-screening for PROVE 3 in mid-January.  Obviously that hasn't happened, and now I'm told I may not get in at all because of my eye issues.  Now pre-screening will begin in April.  Meanwhile, I have lots going on in my life, invitations to travel and many other things, things I know I won't be able to do if I get into treatment.  It's extremely frustrating and emotional, to say the least.

I got so angry a few days ago I just said, the hell with it.  I'm going on with my life and if PROVE 3 comes at an inconvenient time for me, I just won't treat.  I don't care anymore.  I can't stand the waiting and having this f**king disease running my life as well as my husband's and family's.  At least I haven't been told no yet, but I'll post when I do hear no, because I think that's what will happen.  You know, you just get so sock of the whole f**king thing!!!!!

[APKhaos]

sincebirth said, "I have not looked at the list of qualifications to get into the Vertex trials but I assume the following:

Probably
Ages 20 to 50
Low BMI
Low initial viral count
NO relapsers
Avoid slow responders
Low fibrosis stage

All these things affect outcome and they want only the best candidates to get SVR making the tests "look better"

My problem with this is that the final set of selected patients is not reflective of the general public with HCV. Therefore, if they get say a 85% svr rate it may be more like 75% for the general public."

Don't think that's accurate, at least based on my experience with Prove 1. Lets see:

Ages 20 to 50 >> North of that
Low BMI >> Yes
Low initial viral count >> My screening VL was 27,500,000!
NO relapsers >> NA for Prove 1
Avoid slow responders >> NA for Prove 1
Low fibrosis stage >> My bx showed stage 3

Its the clinical centers running the trial groups that choose the subjects. I doubt Vertex would be stupid enough to risk having the entire trial thrown out by FDA because they were seen to be involved in subject selection. They are spending a ton of money on these trials, remember.

[andiamo]

Here is the inclusion/exclusion criteria for Prove3:

Eligibility
Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

    * Males and females between 18 and 70 years old
    * Detectable plasma HCV RNA > or = 10,000 IU/mL
    * Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin
    * Can not also be infected with HIV (AIDS) or hepatitis B
    * Must be judged to be in general good health and able to receive Pegasys

[prettydamscared]

That's so disappointing....I really can't even imagine how I'd feel. It sounds like you really had your hopes up and then to be so disillusioned. We all understand the dynamics of the studies but it doesn't help to understand the whys and wherefores, not when it's us experiencing the loss of hope.  I actually think you're wise to see a couselor....this is a tough blow to take on top of the many other disappointments that we deal with with this disease.  I slso understand the fear in waiting...I was just dianosed in April and started treatment in August partly because I had the opportunity to be in the study and partly because even though I have minor liver damage, I was very afraid to wait.  I sort of jumped into it.... don't know if I'd do a phase II study again.  I too hate this disease and hope so very much that a year from now, we all have more successes to report or at least more hope for help in the immediate future.

I wish you the very best willows and hope the couselor can offer some solace or at least allow you to vent in a way that does make you feel better.

Charlotte

[willows]

I'm still processing what little I have learned about trials and to put it mildly, I pulled off the rose colored glasses and stomped on them.

I have decided see a counselor again, only because I'm kind of angry about learning the truth, I expected this rosy picture of them welcoming me with open arms and I would get a chance with the new meds.  Wow, was I wrong.  My doc said viral breakthru would be one of the last groups tested, and that VX may be approved before it was even tried on a few groups.

So, I'm going to the counselor, learn to accept the news and to learn to be patient again, I have waited a year to be here, and now I' being told to wait another year.  I understand EVERYTHING is done to hurry the drug to market, I agree most whole heartedly, but kind of leaves some of us hanging for a while.  I'm gonna talk to somebody who I will pay to listen to me vent, plus help me get over the un natural fear I have of waiting even longer.

I hate this virus.

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".)  

[sfbaygirl]

What REALLY bothers me is that these trials do have there scarifical lambs, those they KNOW won't get SVR and also will become drug resistant from the tx they recieve from these trials. 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. I know I am very cynical about trials and know we would have nothing if it weren't for trials, but it still bothers me that many unknowing patients have no idea that they are being sacrificed for the cause of others down the line. They give up their own ability to tx again in some cases b/c of drug resistant after a time. Re treating, given the the recent study that shows us that it is not effective in many cases means we need to get this right the first go around, or risk less success next time. I am sure these "sacrifical lambs" are not given the warning that they are the "ones" or given a choice to be so.

Also from what I have heard about Vertex is, yes, it may be great in the short term but the chances of reemergence of the virus is problematic. (Just my anecdotal opinion w/ alittle help from my medical buddies).

It's just a shame that we suffer with anemia, low WBC, without rescue drugs, not enough Inf to start with, no tapering after the 48 weeks, too many questions unanswered by most dr's due to ins. co and SOC set up by orgininal trials. We have to go to Mexico or order oxymatrine online (harmless and have proven effective and safe) as well as Alina, which babies can take without problems. Dr's can't take the chance to give us these helper drugs b/c they are not in the SOC protocal and there butt is on the line if they do. As HR says, you have to almost have a family member give you a script for Alinia. All this because the orgininal trials were approved this way and now, even with more research, there is no variance from this protocol. We are the ones that have our SVR chances diminish due to the ridgid way ins. co's deal with us.

[purplecat]

Thanks to the Aids political lobby we have Fast Track.  The VX950 approved for Fast Track Dec 2005. Hopefully will be here by 2008 for everyone. Used to be 10year wait.  Thats the way I look at it.  The pie is maybe only a little over 1 year away! For those who qualify I thank you for being part of the trails. For those who are not selected, take care of yourself and I pray the wait is soon enough.

[sfbaygirl]

Yes, I agree. They don't necessarily plan that people will fail, but they KNOW that those getting only the mono tx won't have as much chance and can have resistance later. Of course we need trials, but I just hate the way it is.

[Imagine]

Hi baygirl,
Hope you are having a good Saturday. I am on my way out the door for work but was reading this thread and just had to offer this. I may be wrong but when you said "What REALLY bothers me is that these trials do have there scarifical lambs, those they KNOW won't get SVR and also will become drug resistant from the tx they recieve from these trials." I had to chime in.

I would think any drug company that had a drug going through clinicals would hope to have a 100% success rate. I can't imagine they are looking for candidates to include that they KNOW will fail. It does not make sense for them to do so.

Just my two cents.

[jmjm530]

Not as up on the trial situation as others, but they may only be accepting non-responders (as opposed to relapsers) in this particular trial. Something you should be able to find out independently of what an individual trial doctor tells you. Call Vertex and try and get hold of the exact trial criteria.

In any event, using certain criteria does  not mean they're "cherry picking" just following a planned protocol. It's apparent they are expanding their trial population as they move from one trial phase to another, so -- assuming things are successful -- it's just a matter of time until your number is called. Trick, of course, is to be in the right place at the right time -- so, keep track of all your contacts, etc, and call them periodically so you will be first on line when things change.

All the best,

-- Jim

[willows]

Hey, the word did make it thru!!  My worst habit is swearing, it is always a New Year's resolution to stop.  Never works.  There is something empowering about letting rip with a few swear words, especially when I am feeling like I am in the control of some big drug company.  

But again, you are all right about skewing the percentages as much as they can to get the drug approved.  Which is really what we all want and most of us can use, so I will find something useful to do with the pits, maybe plant them while I wait.  

My heart of hearts just want the darn medicine to be out there and give me a chance, along with a lot of us, to try it along with a polymerease inhibitor as a cocktail and none of us ever have to say the words interferon or ribavarin again, oh and the big one, Hep C.  What in the hell will we talk about then?

Willow and pits

[ladybug52]

You're in top form! Really you sound great, you're missed when you're not here. Yeah my little word snuck thru! I feel like I'm really getting away with something! Don't tell!
BTW, what you say is so true re: SOC. Think how much awareness had to be raised for HIV before people began responding. We are shaping the future for tomorrow's victims by educating the medical community ourselves!
Janice

[sfbaygirl]

Hey the word made it through! Maybe we could do some identity theft to get into some trial (not that I EVER want to be in a trial). I think there have to be sacrifices in these trials and I sure as hell don't want to be a sacrifice. Although with the SOC, we are virtually stuck into a cookie cutter tx that most likely could be improved dramatically, if we werent' stuck with relying on FDA approval and doing things one way. Like now, people can't get ins co to pay for 72 weeks if they need it. They are stuck into the only 48 weeks (like my old dr). Still not sure how this will all work out for me. I'm sure in the future people won't have to go through the drama we have to to get rescue drugs or double dose tx, or extention. GRRRRr don't get me started.

[sfbaygirl]

Good point about the trials not being representative of the general population. I guess those of us that won't fall into these catagories get "the pits" instead of the pie.

It seems that at first they would want to skew results to make sure that they get FDA approval, they must do the trials, right? At the phase 3 though you would think they would loosen up a bit.

[FlGuy]

I'm already in over my head on this, but they might 'lump' the non-responders, relapsers and breakthroughs into a single category of 'treatment experienced'. It's good thing that you are pursing this - you owe it to yourself.

[willows]

You got it so right, I believe.  But I am a geno 1, viral breathru at 24 weeks, not considered a non-responder, not even a slow responder, but viral breathru.  In a big way.  So I'm feeling like the last kid in line picked for dodge ball.  

My doc said "wait".  Never did four words put such a knot in my bonnet.  Untying the knot...something to do while I wait.

I hate this virus.

Willows

[ladybug52]

Well darn! How much would it cost to get a new identity? A new person with the right stats and no previous tx, or esp. viral breakthru would have a better chance of getting in! Sometimes I regret all the documentation that is floating around re myself and this ****. I know my bad word got starred out, it always does. Hang in there, cherry picking should be out-lawed for these drug trials, but hey it's their money right? How can we expect them to be fair too?
Bug