a moral question

[Andiamo1]

Those of us that decide to enter a drug trial do it for a number of reasons.  In my case, the overwhelming reason was fear that I didn't have enough time left to wait for FDA approval and after 7 failures, I knew I didn't have the stamina for 72 weeks of SOC.

I also wanted to do something for the HCV community.  I entered the trial with the goal of sticking to the rules to the best of my ability.  Up to now, I have done so, but I am not sure I can continue all the way to the end if I end up in the 48 week arm.

I feel that I owe Vertex something, since they are providing the drug to me in return for my participation.

Personally, I feel that Vertex violated my trust, by providing data to stock analysts that make it difficult for me to understand why I should subject myself to 48 weeks of treatment, with all the associated risks of permanent damage.

The CEO of Vertex has said to analysts, that 24 weeks of treatment are optimal and that people that achieve undetectable status by week 4 have a 90% chance of SVR.

That sure put a damper on my desire to tough it out for 48 weeks will Vertex keeps the study blind.

So do we study participants owe Vertex enough to stick with 48 weeks if that is where we are randomized?

[FlGuy]

Two things jump out at me.  First, it's a trial and they are trying to determine optimal meds, dosing and duration. Second, you signed up for it.  I would imagine there was some level of disclosure and some acknowledgement of informed consent.

[orphanedhawk]

I think the problem is you are thinking as an honorable person with strong moral values. Vertex is working as part of a corporation aimed at increasing profits.  

[wyntre9]

Yikes!  that's a hard one.

What week are you at now and have you reached UND yet?

And what are the legal repercussion if you opt out, now?

As far as owing any huge corporation anything . . .ummmmm. . . well, IMHO, people and institutions have to earn my trust.  If they've gone against their contract with you, by publicly releasing info regarding the trial participants and you feel that the deck is already stacked against you and you have tried TX 7  times and don't feel like you can continue, well, i'd say do what's best for you

And while it's true you signed up for the trial, it's not like the army. . .

So, if i were in your shoes I'd probably be pretty darned PO'D.

but maybe you could explain a little more about the CEO report to the analysts or provide a link to the report?

Wyntre

[susan400]

I was totally abiding by the study rules, while I was still actively receiving the drugs and 'in' the study.  But, once I was taken off study, I honestly don't see why I would have to keep from talking about my experience.  So, for that reason, I won't 'not' write about what my experience was.  However, if I was fortunate enough to still be participating in the medications part of the trial, I think that I'd probably be leaning towards sticking with the rules.  Just because, it would seem like that right thing to do, to me.

Susan

[web52-1]

your informed consent said you can withdraw at any time, should you decide to do so, for any reason. vertex has thus given you permission.  for me, the 12 weeks of vx950 was really horrible, but i was able to get through the whole 48. i thought about stopping many times, but a "moral obligation" to vertex was never much of a consideration, given the withdrawal clause.  regarding their thoughts on 6 months being optimal, this is based on short term data. nobody knows if the 3 month (90% chance of svr) and 6 month rules apply to people who took vx950 in addition to soc. best of luck to you whatever you decide; and please keep us posted.

      

[Andiamo1]

The CEO was doing a Q&A after the 2nd quarter results were given and that is when he said that patients that became undetectable at 4 weeks had a 90% chance of SVR based on the trial results so far.  The stock jumped 3 points following that call!  I think the actual statement was that there was a 10% relapse rate for EVR responders.

I have a lot of brain fog between the SSRI withdrawal and the TX, so I apologize for not remembering the exact quote.

[Andiamo1]

FLguy:  The other side of the question is what moral responsibility does Vertex have to those of us in the trial.

I signed up to cure myself and help the HCV community.  I did not sign up to simply lift the Vertex stock price.

wyntre9:  The CEO quote came from yahoo finance and I can no longer find the link.  I will look tomorrow and see if I can find it somewhere else.

Susan/Hawk: I do think there is an obligation to stick to the rules.  My question is has Vertex abrogated the agreement by posting interim results that help them without regard to the stress that the disclosure places on people in the trial?  My belief is that they now have the obligation to lift the blind for all arms at 24 weeks.  We are not cattle in this trial and there are significant downsides to staying 48 weeks when there is no need.  

What is Vertex's responsibility to the trial participants?

[Andiamo1]

It is the moral obligation that Vertex has to the patients that I am thinking about.

I agree with you about the consent form and I think everyone's responsibility is first to themselves and their health above all else.

It is a very difficult decision and one that I may not have to make if I am in the 24 week arm.  I think the results might be different for the experienced patients compared to the naive.  I also think that non responders will be harder to treat than relapsers and will have different response rates.

The problems seem to be more with Viral breakthrough than non response.  I have not heard of anyone on triple therapy that did not meet the 4 week criteria, only the group without riba in the therapy.

[web52-1]

you wrote: "My belief is that they now have the obligation to lift the blind for all arms at 24 weeks."   i thought they do lift the blind at week 24. they did in prove 1 (then again, i didn't get any results till around week 28 or so if i remember correctly). vertex responsibility to participants is spelled out in the consent. they never said they wouldn't release any data or preliminary group results.  i think you had expectations regarding the company that may have been somewhat unrealistic, and are angry that they didn't live up to them.  my advice (for whatever it's worth) is: whatever you decide, do it for YOU.

[wyntre9]

Are you aware of your stats, yet?  Have you reached UND?  Or do they only tell you t the end of the trial?  

I've never participated in a trial so I'm not sure how it works.

I do  believe you must do what's best for you, healthwise.

I've read other studies that discuss the trial drop-out rates so evidently it's not rare.

Best of luck with your decision,

wyntre

[Andiamo1]

The trial is blind until at least 24 weeks, so the only information I have is the standard liver panel.

I do know that I passed the 4 and 12 week criteria, but that criteria has changed and there is much confusion about what it currently is.

[Andiamo1]

No problem.  I think we all are in this together and that is what is so helpful about this forum.  I really appreciate hearing your thoughts on this.

[susan400]

Andiamo,

I'm sorry, I didn't mean to imply that you had done anything wrong!   I would have a hard time thinking about the whole 48 weeks idea, too!  It was hard for me back when I was on the other treatments for 48 weeks and I had a hard time on the 5 weeks that I was on the Telaprevir and Pegasys, so I can only imagine how hard it must be for you to be thinking about the 48 weeks.  I wish only the best for you!

Susan

[Andiamo1]

I forgot, you and I seem to hold the record for the number of years in treatment.  Now that I am in my 60s, I find it much harder to tolerate and the side effects more pronounced.

[Alady1620]

I don't think you owe Vertex anything but you owe it to yourself to finish treating so you can have the best possible change of SVR.  However, if you can't make it through, you have to do what is right for you.

As to the moral issue on Vertex's end... you know you are participating in a study and what the risks are.  I don't think it's right to blame them.  

Even tho the drug hasn't been approved by the FDA, they are still monitoring these studies.  When I was on NM283, the FDA reduced the doses on the study but, even if they hadn't of, I was aware of the risks.

[FullOfHope77]

It seems you can control the 24 week experience on your own. Since the consent says you can stop at anytime then you can simply decide to stop at 24 without guilt or any negative results. If the optimal time is 24 wks and that's what Vertex says, then you seem to be in control of your own destiny and the choices are pretty simple. What more do you need to make the call and find out if you SVR'ed. Certainly getting tested somewhere else is easily done to verify you're on course with where you need to be... to thine own self be true in this case. Good luck and may you SVR according to your terms and not a muti billion dollar company's call... I will be praying that you make wise decisions as you 'finish up' your own chosen program...

[jmjm530]

"FullofHope" expresses it very well.

All the best,

-- Jim

[CockSparrow]

Its not Vertex you owe anything to its yourself.
Tough call though and not one i'd like to make on when onTx
The way i see it would be

The 90% SVR rate would be an average of all in the trial.
I am G3 and 48 weeks was never supposed to make any difference for G3s,
yet it does if you fit the right criteria. Not for me though.
10% may look good, but it isnt when you happen to be in it. Well for me it was 20% or so.

The questions I would want answers to
Who makes up the 10% Non SVR rate
        Prior Non responder
        Prior multiple Non responder
        Prior relapsers
        HVL
        Cirrhosis etc

You would need to work out whether you are likely to  gain any benefit to extending to 48 weeks. Do you fit in the10% who NR or are you more likely to be in the 90% who SVR.
This would be next to impossible as it is a trial and you don’t have access to the data you would need to make this assessment, so I feel for you.

What is true is that 48 weeks can not produce a lower SVR rate than 24 weeks.
It may not make any difference and sx may be worse but SVR cant be lower.
What if you relapse. You would alway wonder whether 48 weeks would made the difference.

Me I would do whatever it took to SVR, and if that means over treating so be it.
Man 7 goes at this is truely something. You got my admiration thats for sure.
You and Susan are something special.

So hope you SVR
CS

[Andiamo1]

I agree with all of you.  The difficulty with this decision is that Vertex is holding all the information necessary to make the correct decision and not disseminating it.

My dilemma is that they disseminate information that raises their stock price, but not information that patients need.  I will probably stick with it, but not unless they at least tell me that I am not in the placebo arm.  I have 7 courses of SOC that have proven conclusively that I will relapse if I am on a placebo for 48 weeks.

I refined my thoughts during this discussion and realize the issue for me is for Vertex to lift the blind for all patients at 24 weeks.  Then their will be enough data to make a meaningful decision.

[Andiamo1]

I agree that we all owe it to ourselves to do the best thing for us.  It's just that it isn't clear what the best thing is.

I don't trust data that is being selectively release to boost stock prices.  Are there negative side effects we will hear about soon?  Personally, I feel worse than I ever have in treatment.  Some of that is age, but Telepravir is nasty by itself.

[jmjm530]

Andiamo: I agree that we all owe it to ourselves to do the best thing for us.  It's just that it isn't clear what the best thing is.
--------------------
That seems to be the case in your situation. 24-weeks could be a big risk if you don't know you're in the placebo group and also probably arent' sure what week you went UND, not to mention being stage 3 and haven't treated several times before. Also, the 24-week data prev released is from treatment naives and not for those that have re-treated although it may turn out the differences in SVR rates may not be significantly different. A lot of missing pieces.

-- Jim

[mustangshelly]

I wondered about the 7 times you txed before..what did you go through??? What were the stats for the peg/copeg when it was first introduced??? has it changed? as with any new drug on the market it isn't a question of morality ( do you really think they care about you?) rather a question of MONEY...we should know that GREED is what runs this market as well as many other things...Do what you feel is right..luck :)shelly

[jmjm530]

First sentence should have read in part "having treated" not "haven't treated"

[frijole]

I am failing to see how Vertex violated your trust.  Did they actually post results of YOUR study -- the one going on right now?  Were you previously unaware that the HOPE was that Telepravar could do the job in 24 weeks?  If information was posted from the previous trials then I believe there was no breach.

I like what cocksparrow said about the OTHER 10%.  There is much merit to staying in the program for the full 48 so all the data can be compliled.  You said the Telepravar is worse than any of the other 7 treatments.  There, by your own admission, you are most probably not in the placebo leg, as you would have recognized the symptoms familiar to you.

Fast approaching 60 myself and being a one time relapser, I am very anxious for this to be a good study.  One that will give us relapsers hope or tell us the search must continue.  I can't remember if I have read your liver damage but imagine it must be progressing or you would not be treating at the age of 67.  I do know from my one treatment that things just start to get rough at about week 24 (at least for me).  Hang in there unless it is unbearable.
frijole

[Andiamo1]

Jim:  you hit the nail on the head.  Important decisions and not enough data to make an informed choice.  There is no question that data from treatment naive people won't be the same as experienced patients.  There is also no data about Telepravir responses with people that previously never responded and people the responded and relapsed.  My Doctor thinks the greatest benefit will be for people that responded and relapsed and that is me.

The greatest risk to me is that I might be in a placebo group.  In this case I give up a year of my life with no chance of SVR.  Not to mention the risk of permanent problems.

Shelly:  I participated in the first interferon trial in 1988.  It was a low dose and didn't even have side effects let alone cure anyone.

The successive phase 3 trials were for stronger doses of interferon, interferon and riba and finally pegylated interferon and riba.  I responded to the last trial, but relapsed when I stopped.  By that time I was 63 years old and just couldn't handle 72 weeks of TX.  I left some of the finer details out, but I treated 7 times in total with the last 4 being close to the SOC of today with all the SX.

[Andiamo1]

Vertex selectively posts data from the trial.  It seems to me that they post data that boosts their stock price and are secretive about data that helps patients.  I understand the need for a blind study that posts no data.  I do not understand a study that selectively posts data that makes it stressful for people in the trial.

The trial is miserable, perhaps due to my age, perhaps due to telepravir.  I don't like ending up in a 48 week arm when Vertex has conclusive proof that 24 is all that is needed.  They have considerable data on all of us that they are withholding.  Now that they have made public announcements about the 24 week arm, I think it is there duty to lift the blind for all of us at 24 weeks, so we can make informed choices that are in our best interests.  Surely Vertex has a responsibility to the patients in the trial as well as their stockholders.

I think your comments are wise and well thought out, but put yourself in my shoes.  I would have lived with whatever arm I ended up in.  Now that I know there might be no improvement in SVR odds for the additional 24 weeks, it is much harder to tolerate.

[nygirl7]

It's ALL about the almighty $$$$$$$$$$$.   The people developing the drug over there are Vertex don't really honestly care about anything else than that.  Maybe there are few honorable scientists who got into the field because they care...but at the corporate level they ONLY care about one thing.

I agree 100% with this
I think the problem is you are thinking as an honorable person with strong moral values. Vertex is working as part of a corporation aimed at increasing profits.

That is the problem.  As a decent person you want to believe that they care but on the real side of the equation - they don't. The trial isn't about YOU getting better, it's about figuring out a way to make it work so they can make money.

They have not provided any real informative information to us, the regular public & patients, usually all the info that comes out is coming out to drive the stock price and that's about it.

[mremeet]

I feel for ya buddy, I went through a very similar thought process that you're going through right now (except without ANY SVR data coupled with strong uncertainties born of early VX withdraw and immunosuppressants). Bottomline though is that you're an older guy that's failed SOC treatment many times already, so I wouldn't be so keen to quit at week 24 after hearing the rosy remarks from Vertex's highly parsed "news update". And if you have significant fibrosis that's another big risk factor, man you don't want to march into your 70's (and beyond) with the HCV+fibrosis/cirrhosis monkey on your back. Better to stand your ground now and do absolutely anything and everything you can to keep putting one foot in front of another. Not to be overly dramatic, but in all seriousness your life may literally depend on it (which includes the quality of your remaining life as well).

If there's any way you can really focus on exactly why you feel so bad, and put deadly serious effort into coming up with solutions to keep you propped up in the meantime, then thatv would go a long way. Like I know the effexor withdraw has got you down, so maybe really get going on trying a tranquilizer buffet to see what might help? Xanax, valium etc...don't be shy, aggressively pursue all your options. Keep trying different things over and over and try them at a rapid pace to increase odds of hitting a bingo. Get lots of doctor consults and engage in battle! Do whatever it takes. And try your best to educate your wife or other possible assistant(s) to work with you. Communicate to her/them the gravity of the situation you're in and let them know you need help (this is no time to be a macho man dude). Get her to really help you research your problems, make phone calls and take you to your visits. This is war, and you need an army on your side. Time to get medieval knievel on this sh!t man!!!!!!!!

[Andiamo1]

Unfortunately, I think you are right about this.

I have decided to make the decision about treatment based on what is good for me and Vertex is out of the picture on this.  The problem is I don't have the information I need to make a good decision.

I admire your courage in sticking it out for 72 weeks.  I no longer think I have the stamina left to do even 48 weeks without a significant sacrifice.

I have decided that this is probably my last chance for a cure, so I need to give it the best shot that I can.  I am going to wait until week 24 and see what Vertex does.  If they lift the blind, I will make a sound decision based on the 4 week response.  If I am in group D then the decision is made for me and I am done.

If I am in a placebo, I will probably lose it and you will read about me in the newspapers - LOL.

At one time, I like to think I had the courage and stamina that you have now.  I don't any longer after 7 times in treatment and 67 years old.  You have been an inspiration to me though, and I will tough it out if my 4 week results were not undetectable.

[Andiamo1]

I agree 100% with you and I have decided that I will do whatever I can to keep going.  I did get some lorazipam and got a good night sleep last night.  

Perhaps when I am off Telepravir, the sides will improve.  I understand that I can get procrit after the 24 week mark and that will help significantly.  I am stage 3 and my doc felt there was not much time left if I didn't do something and 72 weeks of SOC is not possible for me.

[frijole]

I still think that as a responder/relapser you cannot go by the information which is presented for treatment naive patients.  My gut feeling is that the 90% SVR rate advertised by Vertex is representative of these treatment naive patients.  I fear we will not fall in the same percents, if the r/r (responder/relapser) data were segregated.

Although I can't exactly walk in your shoes, I had many of the same feelings.  I had a viral load of 40 IU/mL at week 12.  I had to sweet talk my doctor into extending.  He saw no need, and I think most GI's and may hepatologists would feel the same.  So I talked him into extra weeks, but I had to convince myself every week during "overtime" that this was necessary -- that the extra weeks would be valuable.   I didn't really believe it, I just had to try to convince myself I did.  Unfortunately my arrogance led me to believe 36 weeks clear would be sufficient, instead of the  documented 72 weeks.  Thus I did 56 weeks and did, indeed, relapse.  

When you started the study you were apparently okay with the 48 weeks.  What is the difference now?  I think it may just be battle fatique.  You must do what you need to, but it sure sounds to me that you are in the leg taking the Telepriver and should try to stick it out.

frijole

[mremeet]

Not sure if your ferritin levels have been checked yet, but if they are low that can definitely be exacerbating your anemia. PLN here had low blood iron during her prove 1 experience (24 weeks) and was really dragging a$$ as a result of the treatment drugs making things much worse. She was put on iron supplements and felt much better almost instantly (she later went on to SVR). Excess iron can increase viral replication in HCV+ folks, but if you're iron deficient then raising your iron levels up to normal (and appropriate) levels may really help you during this tough time.

[Andiamo1]

It is battle fatigue and also the fact that  we sold our house when we planned to sail for two years and now I am taking the drugs while spending part time on our boat and part time in rented appartments.  I think the lack of a home is adding to my craziness.

We can't sail, since I have to be back at the medical center pretty often and sailboats are very slow.

[VXman]

One possibility that I'm sure that you have considered, would be to have your primary care physican order an independent viral load test on Week 24 concurrent with the trial blood tests. You won't have an opportunity to see any of your trial lab results while you are still enrolled: however, you will have full access to your privately ordered blood tests. If you are UND based on the private results, stop treatment and don't look back. You've paid your dues.

[Andiamo1]

VXman:  Unfortunately, it is the 4 week test that is the critical number.  That is the best predictor of SVR and I don't have access to it.

mremeet: ferritin levels are normal, so not that.  I think Telepravir adds to the anemia problems caused by Riba and the combo is brutal.  My Hgb is 10.3.

I believe I can have procrit after 24 weeks if need be.

[wyntre9]

I'm glad so many people advised you to do what feels right to YOU!    "Morality" and "Corporation" in the same sentence seems oxymoronic!

I've got my fingers crossed that you're not in the placebo group and that at 24 weeks you'll get great news about your progress.

In the meantime, if it's any consolation, I'm now at week 32 and compared to how I feel now, the first six months were a breeze.  (I have 40 more to go).  And I'm a first-time TX'er.  So I can only imagine how hard the SX must be hitting you after 7 previous attempts.  This stuff is grueling.  For the first time, I've seriously started thinking about stopping at 48 weeks, or even before; that's how bad sx are.

I moved recently, too, for the same reasons; financial.  i couldn't afford to keep insurance going and maintain the house so it became an issue of which was more important, health or money?

I thought I'd be able to handle the move but I've been going through it since April, almost 5 months, and although i'm finally getting the cottage in shape, it's been really rough.

Living part time in apartments and part time on the boat has to be disorienting!

Glad to hear you got a good night's sleep last night.  

Worry about yourself, not VERTEX!

Wyntre

Wyntre

[Andiamo1]

Our original plan was to sell our house in Norwalk, CT and go sailing for two years after I retired, then buy another house wherever we decided to live.  We sailed to the Caribbean for the winter, up to Maine for the summer and back to the Caribbean for another winter.

We had a blast doing that.  Then the opportunity came up to get into the Vertex trial and we decided to go back to NY, so that I could do the trial.  We have been here since April and you are correct, it is disorienting, not having a permanent home.

I have been lucky in my career, so we can afford to buy a house and we will once we can leave NY.  I guess that is another reason that I hope the trial ends at 24 weeks (October 1).

From your description it sounds like you are not having an easy time yourself.  Why are you thinking about 72 weeks?  Did you not respond quickly?  I found in previous treatments that I seemed to bottom out at about  6 weeks and then improve slightly.  Sometime in the last third of the treatment things would always get much worse.

I hope you feel better.  I had a good night sleep and a good day in the stock market, so I am feeling better :)  We went to see La Vie en Rose - about the life of Edith Piaf.  Makes my life look like a walk in the park!

[wyntre9]

I Looooove Piaf!  "No Regrette Rien" is my favorite

Glad your day was better.

I'm aiming for 72 weeks coz I'm G1A, starting VL 1,140,000, and i didn't reach UND until after week 12, around week 18.

The recommendation in such cases is to extend TX for another 6 months beyond the original; 48 weeks as the relapse rate is reduced from 1 in 2 to 1 in 3.

You're right, I'm having a rough time - just dealing with the attorneys, the buyers, the realtors the handymen, the movers on top of bad sx almost drove me over the edge.

But I'm gonna  keep going and hoping I'll have a good day tomorrow . . .

WYntre

[Andiamo1]

wynre: Good luck with the closing. I highly recommend the movie if you love Piaf.  The leading lady is remarkable and the music is great.

All: thank you all for your support and advice.  I have decided that any decision I make will be based only on my health and family needs - not Vertex.

In 9 more weeks, I will find out much more information: if I am in group C the trial will end and the blind will be lifted.  If I am in group A or B, I am not sure what I will be told, and I might have to make a decision without enough data.

This is probably my last chance for SVR given my age and liver stage, so I will err on the side of caution.  Perhaps Vertex will feel some sense of responsibility and lift the blind before 48 weeks.  If they don't, I will do my best to go as far as possible with the trial.

Thank you all once again for the great support that certainly made it easier for me to get a grip and apply logic to my decision making.

[frijole]

I can understand your plight totally.  IT seems that travel eludes us too.  First it was my dad's illness that took all my vacation time, then it has hubby's dad's Demenitia that requires us to be in town almost every weekend, then it was treatment that delayed everything for a year, and I too look at another treatment at sometime that will put everything on hold.

At retirement all we really need is health.  What good does money do if you don't feel like doing anything.  I am pulling for you.  I really hope this treatment will be the last you will ever need and you can travel and sail your heart's content.

frijole

[Andiamo1]

Thanks and I hope you get to travel yourself.  Will you treat with VX when it is FDA approved?

As annoyed as I am with their trial management, I do still think they are our best hope for the near future.

[frijole]

I will probably treat with Vertex when it is on the market.
  I am on the research list at the hepatologist's office.  We shall see if I ever get called.  I am a G1/S1 so even if I do nothing, I will probably be just fine.
frijole

[GoofyDad]

There's a ton of stuff in this thread - ain't there?

OH:
"I think the problem is you are thinking as an honorable person with strong moral values. Vertex is working as part of a corporation aimed at increasing profits."  

Surely morals and profits can co-exist?  We can start with Craig whazzisface from the famous List. Bill Gates and Warren Buffet ain't doing too shabbily either.

NY:
"The trial isn't about YOU getting better, it's about figuring out a way to make it work so they can make money."

Seems to me the driver behind the trial is satisfying FDA requirements to get the drug to market where it can be prescribed - and mostly paid for by insurance companies (the other evil axis). Looks like a good thing to me.

Capitalism works. It's what created the prius, and solar panels, and rock and roll, and boob implants. It's all good, NYgirl.  

Andiamo:
"The CEO of Vertex has said to analysts, that 24 weeks of treatment are optimal and that people that achieve undetectable status by week 4 have a 90% chance of SVR."

If you think he's lying - that's an issue (but of course you could just ignore it if you don't believe it). If it's truthful, then I'd be happy to have the information - even if it makes you wring your hands a bit.

They get your data in exchange for your treatment- as long as you don't falsify that - no worries, I think. So you effectively move yourself from one group to the next - they get the data either way even if the group distribution isn't exactly what they had planned - but hopefully they designed for that likelyhood.  

You went into it in good faith with the information available at the time. What if patients were now dropping like flies - of course you would have the moral grounds to quit. The landscape has changed. As long as you were honest up front and honest now - I don't see St Peter blackliisting you for this... of couse since I don't believe in heaven, that's probably not a very compelling point - but you get the idea.

Now whather you should stop - that's another deal entirely - most patients on your path would have been clear long before this trial. So you are not a normal patient. On the other hand - will 24 weeks more of SOC make a difference for you, since you've proven resistant to SOC? Maybe your die is already cast, either way? That's a difficult problem to fathom.    

Good luck and godspeed.

  


  

[CockSparrow]

Goofydad - Surely morals and profits can co-exist?  We can start with Craig whazzisface from the famous List. Bill Gates and Warren Buffet ain't doing too shabbily either
________________________________
I work in IT and Bill Gates/M$ (Microsoft) dont have any morals. Just ask Netscape, Word Perfect, Oh hell the list goes on for ever you get the idea.
CS

[Andiamo1]

Interesting post with a lot of good points.

I believe, and so does my doctor, that I am no more resistant to treatment than the average patient.  I participated in treatments in the early days that had no chance of success; they did not include riba at first and then no pegylation.  I was a slow responder to pegylated interferon, but did clear by week 24.

The main strength of Vertex appears to be in the rapid clearance of the virus in the first few weeks and that probably happened with me, since I passed the 4 week criteria.  There is enough data available now to show that patients either clear by week 4 or have breakthrough.  Vertex eliminates you from the trial if you experience breakthrough.

So the question for me, is how long to stay in treatment if I am in the 48 week arm of the trial.  If I am in the 24 week arm, the blind will be lifted and I can make an informed decision about continuing with SOC on my own if I had a slow response.

It is the 48 week arm that is problematical for me:  if the blind is not lifted, I will have no information about rapidity of response, so no way to know how long a treatment is optimal.

My complaint about the Vertex CEO is based on selective release of trial information that is designed to raise the stock price without any consideration of the emotional impact that information might have on people in the trial.  By announcing that the optimal treatment is 12+12, what message is he sending to people in the 24+24 arms?  My interpretation is that we are lab rats that will provide useful information to Vertex as they design the follow on drug.  I have no interest in doing that at the expense of my health and my family relationships.

Because of my age and stage 3 biopsy, this is the only game in town for me.  Because of that, I will have no choice but to stay in the treatment even if the duration causes serious problems to my health and personal life.

[frijole]

Although the CEO of Vertex must be held accountable to the stock holders, I don't think profits are the sole motiviation.  And let's say he is profit - oriented.  That does not particulary hold for the research scientists who are designing and researching.  To my knowledge, medical research is not the field you enter if high profit margin is your goal.  ( think plastic surgery).

andiamo - even though you participated in early research programs, it sounds like you didn't respond well to INF.  I do think you are outside the statistics of the "clear at 4 weeks 90%" realm.  You still have a few weeks to wait to make your decision, but if it added a few % points to your chance of clearing to go the 48, I sure would.  ANd I do think we have some moral obligation to stay within the guidelines of the treatment.  However, if it were me, I would get an outside PCR and pay for it myself
frijole

[Andiamo1]

I always appreciate input, but I am seeing one of the top hepatologists in the country and I have to give his opinion more weight than yours.  Because of my age and stage 3, I am outside the normal criteria, but no one is sure if the same rules apply to a protease inhibitor.  I do not believe the number of previous trials indicate anything other than they were early drug trials that simply didn't cut it for anyone - not just me.

While I think Vertex must have many fine people working for it, the corporate persona is defined by the board and the CEO, not the research scientists and that is what I am critical of.

A pcr at this point will only tell me that I am undetectable.  It is the early PCRs that I need to see and I don't have access to them.

I signed up for the trial to help myself and to help Vertex define the proper protocol for the drug.  The CEO announced that they already know that and it is not 48 weeks.

[APKhaos]

This dilemma raised its ugly head in Prove 1, along with a large dose of assumption that Vertex [or any pharma with a drug in trial] was manipulating the situation to their benefit and to the cost of the subjects. Last time I took this on I was accused of being a Vertex 'mole', but lets just not go down that paranoid rathole again, OK?

At the risk of some over-simplification, there are two issues in play here.

Firstly, you have the right to withdraw from the trial at any time and without stating a reason. Nobody can compel you to remain in the trial. Your data is largely lost to the trial in the sense that there will be no further dosing and/or followup data for you. I suspect that the effect of this is minimal provided that the great majority of the trial cohort goes the distance. So, its your call. whether anyone here thinks its wrong or right, its your call. Like you, I was late stage 3 and had some people here telling me that I was taking a huge risk in putting my faith in the Prove 1 trial. Turns out that a solid SVR made the trial a far better bet than any other treatment solution on offer, but all Prove 1 subjects were naive. Prove 3 is a different deal given you have all been through this treatment dance before.

Secondly, I really question your assertion about the company's actions.
You said, "Personally, I feel that Vertex violated my trust, by providing data to stock analysts that make it difficult for me to understand why I should subject myself to 48 weeks of treatment, with all the associated risks of permanent damage. The CEO of Vertex has said to analysts, that 24 weeks of treatment are optimal and that people that achieve undetectable status by week 4 have a 90% chance of SVR. "

There are a couple of things to consider here.

First, the only significant data that Vertex has at this point is from Prove 1 and Prove 2, both of which are exclusively naive subjects. Its way too early in Prove 3 for enough statistically significant data to make public statements. More importantly, its highly likely that the results from the result profile from the non-responder and relapser cohort in Prove 3 will be significantly different than that of the naive cohorts in P1 & P2. Before you assume that your Prove 3 data has been used as the basis for public statements, it might be a good idea to do some fact checking. I've listened to or read most of the Vertex analyst conferences, and all discussion of results in terms of SVR and treatment profiles, especially the '24 week model' have been directly specific to Prove 1 and Prove 2 data. That was certainly true of the recent analyst call in the last couple of weeks.

Second, this is a double blind trial. The company, and the Chief Investigator, have no knowledge of the identity of ANY subject. All the history and data they collect is identified by a subject number only. The only people who know which number belongs to which subject are the individual investigators at each clinic participating in the trial. So, there is no way that you could know if your data was used for any interim statement, and no way that the company could know that they were using your data either. Conspiracy theories abound, but the facts are the facts.

I really appreciate that this is a tough situation. To some extent I've been in the same place durign Prove 1, but without having suffered through multiple treatments without success as you have. My only point is that its a call you have to make, and you really shouldn't try to make some imagined action by the company part of this decision. Assume good will, and make the decision that is right for you. Its your call.

[susan400]

Andiamo,

Didn't Glucklich on the other board, say in his recent posting that he would find out today whether or not he would be continued on from his week 12 point w/the Vertex?  Have you seen any postings from him today?  I hope his news is good.  

How about you?  Are you hanging in there?  

I don't go back to my trial site for the next follow-up until Oct. 1st.   Until then, I'll just stay in touch w/my regular doctor's if anything comes up.  The trial site study nurse did tell me that my 2 week post study labs showed that my white cells were still below normal.  I think they'll probably rebound to normal.  My neut's were still low, too.    I'm getting an off study CBC done on Mon. and I'll make sure on that.  I didn't think it would be a good idea to let it wait until Oct. if it was still real low.  I'd want to know, because of getting exposed to sick people and things like that.  My neut's were at 1.42.   Not critical or anything, but not in the range where it should be.   My white blood cells were 2.74.    

Susan

[Andiamo1]

I see from all the posts, that unless I write much more detail about my reasoning, that I will be in an endless discussion of the point.

I believe strongly that the CEO should keep his mouth shut about trial results until the end of phase 2.  I also have enough feedback from doctors and researchers to believe that the rules for determining SVR probabilities are in a new realm with a protease inhibitor and blanket statements about SVR probabilities compared to SOC may or my not have any value.

There is some evidence that non-responders might need longer treatment if they don't have breakthrough, but nothing to indicate that relapsers won't respond exactly as naive patients.  If you look at the results from the naive trials, you can see that the predictors for SOC probabilities for SVR don't hold.  Plenty of SVR responders have posted their stats and they would be low probability SVR with SOC at 48 weeks, but they reached SVR in 24 weeks with VX.  I am sure this statement will make people say "but this is anecdotal" and that is a true statement.  It is the only data available except for the selective pronouncements from the CEO.

Any way, enough has been said and I am gong to dream about sailing in the Caribbean for the rest of the week!

[Andiamo1]

Thanks for asking; I am having a meltdown this week.  Probably from stopping effexor. but I can't really tell.

I am actually felling better today, but I seem to have unleashed a monster with this thread.

I didn't see a post from Glucklich and I wonder what the outcome was.

I am fairly positive that I am in the 48 week trial and that is probably a good  thing even though I am having a tantrum about it.  I saw no change in anything at the 12 week point when it should have switched to a placebo if I were in the 24 week arm.

How are you feeling?  Are the SX from treatment leaving you.  I dream about how that will feel.

One issues that you youngsters don't understand is that we all make decisions using a risk/reward ratio. A person in their 40s or 50s has to weigh the loss of 48 weeks of reasonable health against 30 years without the dragon.  At 67, I have less than 10 years at my current physical level.  I sail, jog, work out, swim and walk many miles a day - or at least I did before TX and I doubt I will be doing that at 77 even without the dragon.  So I have to weigh the loss of almost a year against the gain of 6 - 8 years. A very different calculus.

[pigeonca]

I hope you have many more years of strength beyond the age of 77.  I have an aunt who just passed on at the age of 94.  She had to stop backpacking in Yosemite in her late 70's but continued daypacking into her late 80's.  She had just renewed her driver's license and was still working part-time as a tax accountant until 2 weeks before she died.  And her health had not been that remarkable - she'd had a hip replacement and other ailments along the way.  I think that some other form of math far more mysterious than calculus is involved here - maybe the kind of math they use in Las Vegas.  I look forward to seeing your report from the Islands.  Be well.

[susan400]

I'm not in the 'spring chick' category anymore, but don't feel I'm 'senior citizen qualified' yet.   I'm 46.   After 50 I figure, if the good Lord wills and I'm still here, then, I'd have to be more like you and way the treatment decision more cautiously.  I am doing better now as far as the itching.  I don't have to be so freaked out about getting a 'little tiny' bit of sun on me when I'm going out to the store and things like that.  I'm still lagging in the energy department.  I am still having some various muscle aches.  I think that if I were having to get Ribavirin out of my system that it would be taking me even longer to recover.   Based on my past 2 treatments (before this one), the post-treatment experience was a long drawn out process.  It took me about 10 mon. to get back to normal after my double dose Riba treatment.  The treatment before that one was the Actimmune, Infergen, Riba and that took me a long time to recover from to.   All things considered, my body has handled when I've put it through pretty well.  So, I can't really complain about this post treatment time alot.  

Susan

[Andiamo1]

I had decided to stay away from this topic, since it caused me too much stress to keep the conversations going.

But, your seeming notion that there is not a different view when you are 67 then when you are in  your 40s amazes me.

Do you think your endurance for these drugs will be the same or do you think the pain and stress will be harder to take in another 20 years?  Do you think that sacrificing one year of your life means the same to a 67 year old as it does to a 40 year old?

[Andiamo1]

Vertex is going to lift the blind for 48 week people at week 26.  'what a great company!!!

[pigeonca]

I'm well aware of my impending mortality, being 63 and 1/2 myself.  (I'll be 64 in February.)  But I also fully intend, or rather hope, to be up and about for another 20 years or so.  As I watch the previous generation age and then croak, I've noticed that those who keep physically and mentally active seem to do best, unless they get cancer or Alzheimers.  I know a famous screenwriter in his mid eighties who just retired, despite living with cancer for over a decade.  He's kept himself going via a macrobiotic diet, which is extreme but a choice that was available and which has worked so far.  My dad was running marathons well into his 70's, and if he hadn't neglected some obvious cancer signs (he wrote them off as indigestion), he'd still be running 5 or 10K's in his late 80's, I'm sure.

When I was in my twenties, my brother's boss fell over dead at the dinner table.  He was 41, and I thought, "Oh well, he's lived a full life."  It's all relative to where you're standinng.  To me, 67 is still young, and from your photograph, you're still a good looking dude.  Happy sailing.

[Andiamo1]

You have the correct attitude and I usually share it.  This drug trial is the hardest thing I have ever done.  I don't know if it is my age or the addition of Telepravir, but this is rough both physically and emotionally.

I definitely had a meltdown over the last week and seem to be feeling better now.  I will do my best to continue with the trial for the same reason that I turned my life upside down to get into it in the first place.

I appreciate your comments and I will think about them the next time I start to give up on the future.

In any case, Vertex has made life easier for those of us in the trials by agreeing to share the PCR results from day 1 through week 24 when we reach week 26.

That is all I was hoping for when I started the rant.

[cbert]

i have read this thread with great interest. I am a three time tx non responder, geno 1, 3/4 with cirr.........yet i still work as a ceo (i'm 53).  I am considering taking a job with a lighter load since I can tell I am starting to slow down. I am on a waiting list for telepriver. But after the interferon and a really nasty round with infergen, i am really terrified of treating again................although the benefits aren't as good as what i have now (such as paid medical leave) i have lifetime health insurance which i negotiated the last time around........but i can tell i am starting to slip and getting more and more fatigued. I hate to admit it but i may need an exit ramp for this life in the fast lane...........but i reached a point i was barely able to function at work after the last two rounds of tx.............are the sides of telepriver as rough as interferon? Or is it the combo..................

[Andiamo1]

Telepravir currently is taken with the current SOC.  It has side effects of its own, so the experience is worse, but hopefully more likely tp produce SVR and for a shorter duration.

[jmjm530]

cbert: are the sides of telepriver as rough as interferon?
--------------------------------------------------------------
As 'Andriamo" said, Telaprevir is taken with current SOC. The winning trial combination appears to go like this: Telaprevir plus peg and riba for the first 12 weeks. Then Peg and Riba for another 12 weeks. Treatment therefore (for geno 1's) is 24 weeks total, which is half of SOC. Projected SVR rate is 80% based on prelimiary results, so the promise is double the cure rate in half the time. Very compelling. Very compelling to me.

As to side effects, it's how you look at it and in your case, how your body reacted to previous treatments. For me, what really broke my body down with treatment wasn't the day-by-day side effects -- I had plenty and some severe -- but the length of treatment. I feel that if I could have stopped at six months, my body would not have broken down as much as it did, and I would have recovered much sooner. Not to mention what months 6-12 did to the rest of my life -- relationships with friends, family, work, etc.

So yes, it's possible that you may have more side effects with Teleprevir for the first 12 week -- a certain per cent get a rash -- but those side effects apparently go away in the second 12 weeks (period without Teleprevir) and then you're done at week 24.
To me, it's a no brainer, comparing it to SOC.

All the best,

-- Jim

[cbert]

i have already proven i am a tough fighter, having gone through the tx three times. but i'm not sure i can try to work again while doing it.....I have had just about every side effect known. With the infergen i nearly lost a hand to a staph infection that developed and was saved after three very painful surgeries.  And you are right jim about the impact on relationships...............the infergen almost did me in both physically and mentally.  I suspect i will attempt FMLA or disability  if there is a next time around. After three years of intermittent tx the docs told me to take a year off  (except for ct scans and blood work of course) and come back in march of 08.  I am on a waiting list for teleprevir.