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Avatar universal

HCV Clinical trial

Am I the only one in the Atlanta area to participate in Schering Plough's 2007 clinical trial of SCH 503034, Protocol # P03523???

The principal investigator and sponsor refused to provide medical follow up treatment, and now I suffer severe and permanent injuries. I can't put in words my aggravation. I also suffer side effects of the prednisone I had to take for 14 months. Prior to the clinical trial I was in excellent health. After the first injection, my heath went down the drain, and has been there since May 2007. I was told of the risks involved, but I was also told that any adverse effect, the sponsor would provide medical costs for treatment.

If you participated in this clinical trial and suffer adverse effects, and the principal investigator refused to provide follow up treatment, I NEED TO TALK TO YOU!!!

I filed a law suit which may benefit your health.

24 Responses
96938 tn?1189803458
a.k.a. Boceprivir
179856 tn?1333550962
They wouldn't give you prednisone while you are on treatment most likely so it sounds like you have a bunch of other issues - I haven't heard of anyone who took the boce having any serious troubles like this that I can remember. I would think it would be rather hard to sue them as you must have signed off on a whole bunch of legal stuff before being admitted to a 'trial'.
Avatar universal
"After the first injection"  

You don't inject Boceprevir.  Perhaps interferon or ribavirin is the culprit.
Avatar universal
Just my thought, but I would guess on the first day of the trial it may be that all drugs started; IFN injection, riba and Boc pills.

On the other hand...... the Boceprevir trials had several arms; some had SOC "lead ins" in which participants started w/ SOC for 4 weeks prior to starting Boceprevir, others in which all 3 drugs started at the same time.

I've no idea which arm Jerry was in and yes, it could very well be either or an one drug.  It is also possible that it could be a issue where all 3 played a part.

Willy
96938 tn?1189803458
....or placebo.  Meaning the culprits could be just Peg/Riba.  Unless Jerry was unblinded and has knowledge
Avatar universal
You are right of course; that would be a possibility in the trial.

I guess that is assumed that Jerry got the Boceprevir or else he would be posting about the harmful placebo pills he was given.  : )

I believe that all people in that trial have since been unblinded, so he probably knows.

To some extent, I think his issue is that whatever the drug or combinations of drugs were given, his health has declined as a result and that he isn't receiving adequate post TX health support for his issues.

......and he's looking to see if there are other like him, and possibly trying to discern as to whether the issue was related to SOC or the add on drug, Boceprevir.

Willy
Avatar universal
Why wouldn't they give you predisone while on tx?
Avatar universal
"Why wouldn't they give you predisone while on tx? "

Since prednisone is a steroid, I'm thinking it mucks with the immune system somehow, and since IFN is already mucking with it, perhaps they're trying to avoid "double-muckage".
206807 tn?1331939784
Do you remember the waiver you signed?
Avatar universal
My understanding is that on occasion people are given steroids when auto-immune issues may arise.  I believe that this is done instead of ending TX.  The inclusion into a treatment has to be managed and it does decrease the SVR rate, but if auto immune issues arise as a result of TX what other course is to do other than to discontinue or reduce SOC?

I'm not that up on it, but it's what I think I've understood to be the case.

I was also under the impression that long term use of steroids is problematic.

willy
Avatar universal
I do appreciate the attention to this issue. I probably put too much emphasis on the first injection. Boceprevir was started after 4 week lead on with Peg  and Reba. I started May 7, 2007, and in July I was becoming anemic and my reba was reduced to 1000 mg. August my anemia debilitated and I was given procrit weekly injections for 9 weeks. January 2008, I stopped the study drug but continued the FDA approved Peg and Reba at same dosage. After the 3rd Peg injection on standard tx, I suffered uveitis and stopped tx completely.

I was told the side effects would dissipate within a six month period. Mine continued to worsen and, in October 2008, I notify the prinicpal investigator and request medical follow up tx, and he refused to provide it. My medical problem continued to develop into a much serious condition to severe and placed me in the hospital.

Yes, I was aware of the risk of serious bodily injury and wagered the outcome to outweigh 1% chance when I had perfect health going in. I chose the clinical trial because it spared the cost of expensive drugs and consisted of the standard tx with an additive, a protease inhibitor which is suppose to counter the side effects and increase the life expectancy of IFN to fight the virus. But it doesn't end at this point. The informed consent agreement specifically provided a clause that the sponsor would provide medical costs for any adverse effect of the experimental treatment drugs including Peg and Reba.

Whether my adverse event is caused by Peg, Reba, or Boce, the sponsor should still be liable for adverse effects of either drug or combo.

My understanding, prednisone is forbidden in combination tx of Peg and Reba because it inhibits the immunity system and paves the way for the virus.  
Avatar universal
http://en.wikipedia.org/wiki/Uveitis
Uveitis specifically refers to inflammation of the middle layer of the eye, termed the "uvea" but in common usage may refer to any inflammatory process involving the interior of the eye.

Uveitis is estimated to be responsible for approximately 10% of the blindness in the United States.[1] Uveitis requires an urgent referral and thorough examination by an optometrist or ophthalmologist along with urgent treatment to control the inflammation.
------------------------------------------------------
(You wrote)........"Boceprevir was started after 4 week lead on with Peg  and Reba. I started May 7, 2007, and in July I was becoming anemic and my reba was reduced to 1000 mg. August my anemia debilitated and I was given procrit weekly injections for 9 weeks. January 2008, I stopped the study drug but continued the FDA approved Peg and Reba at same dosage. After the 3rd Peg injection on standard tx, I suffered uveitis and stopped tx completely."
------------------------------------------------------
Lets see if





i can recap; you did a 4 week lead in followed by about 6 months of triple therapy.  At that time, in January you stopped doing boceprevir and switched to SOC (just Peg and Riba)  After the 3rd shot of standard therapy w/ no Boceprevir, you suffered uveitis and stopped all TX.

Was the use of prednisone for the treatment of your eye issue?  I also wonder..... is it thought that the issues you experience are due to the prednisone, SOC (IFN & RBV) or the Boceprevir?  Or is is alleged that none of your health issues are due to any of your treatment?

Willy
(it's a side bar to this thread but according to Wikipedia; "The first commercially feasible synthesis of prednisone was carried out in 1955 in the laboratories of Schering Corporation, which later became Schering-Plough Corporation.")
Avatar universal
As many have pointed out, the prednisone and/or in combo with soc and boceprevir does seem  to be the likely suspect in my completely unprofessional opinion. I know you weren't asking for medical advice, but in the interest of our education can you provide more information about the prednisone treatment?

When did you start the prednisone in relation to treatment and why? Who prescribed the prednisone? You took the prednisone for 14 months and treated for about nine months total from what I understand. Did you continue the prednisone after treatment and did the trial investigator treat you with it the whole time you took it including after tx?

As others have suggested. I would imagine that since they use prednisone to suppress the immune system to prevent/stop auto immune issues that arise, it seems prednisone would be completely adverse to interferon's immune system boosting effects.

At the same time, as Willy50 pointed out, what choice is there except to discontinue treatment or use some thing like prednisone when your immune system attacks your body during treatment. What a dilemma for you and your doctor, I am sorry.

Good Luck to you, and I hope you get the help you need and your health returns.

- Dave
Avatar universal
Since you treated for about nine months obviously you were und at some point in treatment. I know this doesn't help your current medical condition, but what is your hcv status currently?
Avatar universal
"chose the clinical trial because it spared the cost of expensive drugs and consisted of the standard tx with an additive, a protease inhibitor which is suppose to counter the side effects and increase the life expectancy of IFN to fight the virus."

I have never seen or heard that a protease inhibitor is supposed to counter the side effects of antiviral therapy.  Quite the contrary -  the protease inhibitors come with their own set of side effects.  Additionally, the protease inhibitors do not increase the life expectancy of interferon.  Interferon ramps up the immune system to kill the virus.  Protease inhibitors are designed to attack and kill the virus on their own.

I am sympathetic to your plight and I hope you get all your issues resolved.

Trinity
179856 tn?1333550962
Unfortunately we all know the chances before we start treatment. Not only do the drug inserts say all the warnings the doctors are pretty explicit about the potential effects.

Don't you have a regular medical provider you can turn to? While it might not be fair honestly I am not too sure what they can do about anything that has developed anyway though.
Avatar universal
for a better idea of what's going on visit the below link;

http://www.medhelp.org/posts/Hepatitis-C/Long-term-side-effects-of-interferon/show/866107?personal_page_id=1835217#post_6395457

his post is Nov 26
===========================
"....I lost 30% vision in my right eye and thought I got off easy and expected the SE's to dissipate; however, my side effects continued to develop into a more serious condition simply because I did not get medical follow up tx of the SAE soon enough. "
===========================

also;
============================
"Although sarcoidosis is listed as a 1% chance SAE, it goes un-noticed til it develops into stages III and IV, and beats your door down for attention. Stages I and II will usually resolve on its own after drug therapy is decreased and/or stopped, but stages III and IV require steroid tx and said to be an incurrable life-threatening disease."
============================

And so based on that post it appears that it is more about the doctoring that Jerry received.

I think he is also looking for other who may have had like experiences.

Willy

Willy
Avatar universal
Thanks for posting the link link willy.

It looks like you've been through quite an ordeal Jerry. I really hope there is some help available for you. Like you said, we never expect to be the 1%, but obviously someone is the 1%.

- Dave
Avatar universal
Protease inhibitors counteract the side effects of the S.O.C.??  I don't think that's correct really.  If anything, since you are still on the S.O.C. and you are adding a 3rd drug to the mix, it would seem to reason to me that you would add side effects.  I know when I was in the Prove 3 Telaprevir trial I had the huge side effect of the nasty skin rash, that I didn't have on standard SOC.  So, I guess, I'm a little bit confused?  Maybe it's the steroids and the asthma Proventil inhaler and the Levaquin that I'm on that are causing my confusion?  I had to start on all those cr*ppy meds on Mon. for acute bronchitis.  It's making me a bit crazy I think.  Why would anybody want to be on steroids if they didn't absolutely need to be on them, is a curiousity to me?  I totally don't understand the abuse of them at all.  They make me feel BAD!


Susan400
Avatar universal
I don't think you are using anabolic steroids for your bronchitis. Anabolic steroids are the class of drugs that people take to increase muscle mass quickly.

Protease inhibitors would definitely not counteract the effects of soc. I guess someone might interpret it this way because in the future new generations of direct anti viral drugs cocktails will hopefully be developed that will hopefully have less side effects then telaprevir and boceprevir and will be effective in eradicating hcv quickly.

http://en.wikipedia.org/wiki/Anabolic_steroid
"anabolic steroids, officially known as anabolic-androgen steroids (AAS) or colloquially simply as "steroids", are drugs which mimic the effects of the male sex hormones testosterone and dihydrotestosterone. They increase protein synthesis within cells, which results in the buildup of cellular tissue (anabolism), especially in muscles. Anabolic steroids also have androgenic and virilizing properties, including the development and maintenance of masculine characteristics such as the growth of the vocal cords and body hair"

Prednisone which Jerry was taking is a different type of steroid sometimes used to treat auto immune and inflammatory issues.

http://en.wikipedia.org/wiki/Prednisone
"Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases and (at higher doses) some types of cancer, but has significant adverse effects. Because it suppresses the immune system, it leaves patients more susceptible to infections.
It is usually taken orally but can be delivered by intramuscular injection or intravenous injection. It has a mainly glucocorticoid effect. Prednisone is a prodrug that is converted by the liver into prednisolone, which is the active drug and also a steroid."

Hope this information helps,
Dave
408795 tn?1324939275
Hey Jerry, I hope things get better for you and you get what's coming to you.  I don't know the facts in your case but it's definitely eye opening to say the least.  My guess is you are hard pressed to find other's who have been denied medical follow up during or after tx in a clinical trial.  Definitely a case with mitigating factors to say the least and to be fair we will most likely only hear your recap of your tx experience.  I do have a couple of questions for you tho.

Is the head doctor of the clinical trial center you were tx'ed at still working there?

Did you see any outside doctor's outside of the clinical trial or their affiliates during this time period?

Are you SVR?  

If these questions were answered elsewhere and I overlooked them then forgive me.  Good luck to you!

Avatar universal
I sincerely appreciate the information shared from each posting, and I will share additional info for the delimma. Fretboard, as much as I know, the doc is still there and has a team of super lawyers. I am undetected, SVR, at least I was April 2009. I think some confusion may be the onset of the timing of events.

I began the clinical research May 2007, stopped the study drug January 22, 2008, SOC began February 2008, and 3-weeks later I have the iritis/uveitis toxic reaction and put the treatment drugs to an end. I was informed that the side effects would resolve within six months after terminating drug therapy.

I signed a written waiver and consent form which specifically provided, "You may ... withdraw ... without ... loss of benefits ... in the event you suffer bodily injury or unexpected adverse event ... the study sponsor will pay reasonable medial costs to treat the injury."

I read the public review concerning the phase II and phase III clinical trials of boceprevir and according to the reveiw, 39 people deceased during and after the study. I have also read other postings in this community which also indicate other people suffering adverse effects of SOC. In my opinion, there is no credence to a waiver of health, or an even swap of tx versus risk, when medical personnel sign on with an ethical oath to put health above all else.

Fretboard and Wily are correct. I am looking for people who are suffering adverse effects of any clinical trial of boceprevir, and have been denied treatment by the principal investigator or the sponsor of the clinical trial. In the not too distant past, I seldomed heard the sound of a clinical trial, and I suspect, because clinical biological testing was too inhumane in the USA, until former president Bush pushed the federal gov't to enact a federal law shielding pharmaceutical companies from law suits of FDA approved meds. The door to clinical trials were wide open; however, in 2009, concerning a case where a muscian lost her arm to a toxic reaction to "some" drug, the U.S. Supreme Court overruled the forbidden law, and allowed the pharma to be sued. Today, the U.S. can be sued when its agency is negligent or violates the law.

It will certainly help me present my case if I had to share the experience of others also suffering simply because a giant pharmaceutical company chooses to withhold material facts, such as serious adverse effects of its toxic drugs.
408795 tn?1324939275
I began the clinical research May 2007, stopped the study drug January 22, 2008, SOC began February 2008, and 3-weeks later I have the iritis/uveitis toxic reaction and put the treatment drugs to an end. I was informed that the side effects would   resolve within six months after terminating drug therapy.
________________________________________________________________
I wanted to include a link to the lady who lost her arm as I didn't want anyone to think it was related to a clinical trial or clinical trial drug, I think this is the lady you were talking about but if I'm wrong you can correct me.  I appreciate you explaining your situation so others can learn and so nobody is scared out of getting tx if that's what is needed.  Also, to be absolutely clear on this issue, you were on SOC when your issues began with the "iritis/uveitis" and not on Boceprevir, so the actual culprit suspected is the IFN, correct?  Oh and one last question.  Do you know the statistical information on the ppl who develop  "iritis/uveitis" issues from SOC?  Thanks again and good luck!  


http://www.foxnews.com/story/0,2933,445529,00.html
Avatar universal
Uveitis is secondary to sarcoidosis, and it is medically well known IFN induces sarcoidosis. Sarc is an autoimmune disease and a type of inflammation with granulomas, and can affect multi-organs, skin, occular and pulmonary. It is suspected that it is bacteria in the granulomas that initiate and cause sarcoidosis.; however, not much is known about it other than chemicals like IFN can induce it or arouse a pre-existing condition, and is usually detected by chest  x-ray. I have multi-system sarcs affecting occular, renal and stage III pulmonary.

I should make clear, my toxic reaction to the treatment drugs was the clinic's complete failure to manage a toxic reaction which allowed the medical problem to develop into a more serious condition. Had the clinic provided follow up as promised, it is likely several weeks of prednisone would have snuffed out the sarcs before it could do any damage. Instead, my sarcs went undetected for nearly a year, and allowed to develop into stage III until I was hospitalized and more than $80,000 in debt. The practicioners involved are rare and far between to breach their fiduciary duty so blatantly, and merely to cover up adverse effects of the study protocol. I suspect kick backs were involved but that is only speculation, and carries no weight, but why else?

If you are deciding a clinical trial, I do suggest investigating and learn what agency the trial is governed. Health and Human Resources appear to provide more protection for the subject and governed by 46 CFR, and trials governed under the FDA is 21 CFR, and appear to have a sleepy watch-dog.

Once again, I am very persistent -- any person suffering adverse effects respond to this posting.

Salute ...
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