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Trial Nurse & Doctor different opinions--What to do ?
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Trial Nurse & Doctor different opinions--What to do ?

I could not get in today to see private doc but he did call me and we went over the blood work.  He is also concerned about high uric acid levels of  9 seeing as this can lead to kidney stones and gout.  He was going to call in some medicine to lower it Allopurinol, but I told him I had to check with the trial nurse first.  When I called her she was in a tissy " I keep telling you there's nothing wrong with your UA, I'm going to call your doctor."  By the way she normally doesn't act like this.  When I got home there was a message from my private doctor that he was going to hold off on calling in that prescription.

My question / concern is which one do I trust.  He wanted my uric acid lowered and she keeps saying it okay?

That's problem one and there's more.  My thyroid has not been right since starting tx and I'm into week 9.  I know for most people here with thyroid issues they are able to get it under control with meds.  This has not been the case with me and my THS is now up to 16 ( normal 4 ), even after adjusting my meds.  This doctor has taken care of my thyroid for 13 years and we have never had problems like this.  He is concerned about this, and stated we would wait until my next blood work ( 3 1/2 weeks ) and if it doesn't straighten out we would have to make a decision what to do then.  He does not want me to go 6 months or 1 year with a whacked out thryoid.  I just pray he doesn't want me to stop tx.  Ooh by the way trial nurse is not concerned about this issue either.  

Maybe I need to get a hematologist because theres other issues going on also.  Hubby is laid off so we have no insurance and I just shelled out $450 for some private blood work.  He should go back soon and think I just may get another doc involved then.  The last thing I want to do is have to stop tx.

Maybe I'm just over reacting but on the other hand I just know something is'nt right.  I don't like the disagreement between the private doc and trial nurse.  

All advice and opinions are needed and appreciated.
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16 Comments Post a Comment
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9648_tn?1290094807
Is there a trial doctor? What do they say?
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179856_tn?1333550962
THS is now up to 16 ( normal 4 ), even after adjusting my meds.

Wow I'm so sorry about this. I don't know anything about uric acid levels but I do know about thyroid. I'd imagine yours is so bad because it happened pre-tx.  I'm hoping that on the syntrhoid mine continues to hold out in the future and when I see something like this it upsets me so much for you.

I agree that you should insist on speaking with a trial doctor or someone on a higher level. While it seems the nurse might have been right (and if she was what does that say for the doctor? OR is it that the trial drugs raised it but it will be ok? OR blah blah blah) I would definitely want confirmation from someone and a REASON instead of just following what anybody said at this point.

You have a right to know what is going on with your body.........always remember that (when they act like you don't).

Good luck to you I wish I had some answers but just wanted to say that.
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Avatar_f_tn
I did think of that today, but after the nurse went into her tissy I thought they might think I was causing trouble.  I definitely don't want to get put out of this trial.

I will think on it for a few days when I have settled down, and decide weather to call or not.  It sure would help if they would explain why this is happening and assure me its not going to cause long term problems.  But then again , they don't really know that either.

I know this may seem like a stupid question, but is my study doctor the trial doctor also?  The study doc is also my Gastro so he should give me some answers.
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Avatar_f_tn
Yes, your study doctor is also the trial doctor.  Study = trial.  I would go above her to your trial doctor and have him explain this to you.

When my thryroid issues started while on treatment, had my family doctor refer me to an endocrinologist.  Mine was lousy.  So my trial doc / nurse had me see one that they have confidence in.  Is the doc who is treating your thyroid an endocrinologist?

Your trial nurse should not have the final word over your care.  Your trial/study doctor should.  If you disagree with her on anything, ask to talk to the study doctor about or contact him directly.  

It's not unusual for the treatment drugs to do whacky things to your thryoid, it's just important to be properly treated for it.  An endocrinologist who understands that Hep C treatment can whack your thryoid all over the place would be great, barring that a treatment doctor who will communicate with the endocrinologist and work together is next best thing.

Good luck.

Trish
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9648_tn?1290094807
My gastro isn't involved. There's a separate study doc whose name is listed in the consent that I signed. (There are actually two of them.) They are the head of the department at the hospital that is conducting the trial.

If that *is* your gastro, then he and the nurse MUST get on the same page. If it is someone else, then they shouldn't deny your ability to discuss things with that person.

Wanting to talk to a doctor isn't causing trouble, especially if you are nice about it. They do want the participants to stay with the trial. I don't know if they get paid differently for completions than dropouts, but I'm sure it's to their advantage to keep you.

Hang in there!

(P.S. If the nurse was in a tizzy it could have just been a bad day for her. . .)
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626299_tn?1316711493
"They do want the participants to stay with the trial. I don't know if they get paid differently for completions than dropouts, but I'm sure it's to their advantage to keep you. "

Then if that is the case would it not be in the trial nurses best interest to tell Tip not to worry about it?

It seems to me that you have a long term relationship with your private doc. I would call the private doc omorrow and ask for any explaination why he changed his mind. Thell him you just want to be informed about your health care decisions. I think you probably stand a better chance in getting some insight from him rather than the trial nurse (who is not letting you talk to trail doc)

Keep us posted! I will be waiting to hear you are in good treatment hands.


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Avatar_m_tn
I'm a bit confused. Is your "private doctor" the same as the trial doctor/study doctor or is the private doctor outside of the trial entirely and therefore does not supervise the nurse in question?

In general, I would go with whatever the trial doctors or trial nurse says as opposed to a private GP or Gastro who is outside the trial. That said, I would also want to run something like this by my trial nurse so you definitely did the right thing and she was out of bounds reacting like that. If you still feel that he's making a bad call, you could ask to speak to the trial doctor, assuming this is not the same as the study doctor.

-- Jim
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Avatar_f_tn
"They do want the participants to stay with the trial. I don't know if they get paid differently for completions than dropouts, but I'm sure it's to their advantage to keep you. "

Then if that is the case would it not be in the trial nurses best interest to tell Tip not to worry about it?
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I think you hit the nail on the head there.  This is exactly how I have been thinking.  I am going to call my gastro but he is also my study doctor so I expect him to tell me the same thing.  Don't worry about it.  Seeing as they get paid by the pharmaceutical companies I don't feel they always have my best interest at hand.  They need me to stay in the trial.

I picked my gastro because he came highly recommended by other doctors and is head of the liver dept, and head of research for Hep C. When I signed the Vertex consent form I saw my gastro listed as the study doctor. I was a tad surpeised and a red flag went up then.   When I did the blood screening for the trial at first I was denied because of Thyroid but gastro called and told me not to worry he would talk with Vertex.  Sure enough a week later I was accepted.  I guess I wasn't thinking clearly because I wanted to get into this trial because it was a NO Placebo trial --first one ever.

jmjm my private doc has nothing to do with the trial.  Yes, the gastro is the study/ trial doc.  

Here's the plan, Trish your right at this time my family doc may be over his head treating my thyroid seeing as we have added 3 new drugs to the mix.  I will be looking for a endo and hopefully I can get this thyroid stable.  We have no insurance so I praying he goes back soon, but if he doesn't I will pay for it out of pocket. Yikes !

Right now the thyroid is the most important issue at hand and once thats ok I will deal with the uric acid.

Thanks to all of you for your input.
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Avatar_m_tn
While anything is possible, I would not rush to judgment so fast that the trial nurse is basing her recommendation on any monetary perks that the trial doctor may be receiving. I would push that thought aside and deal with the issue strictly by merits. Truth is your private doc is over his head regarding treatment issues. Almost all non-liver specialists are.

Hopefully, I'm getting the sequencing correct, but before seeing additional specialists, I would first speak to the trial nurse's boss (the trial doctor) about the issue and get his take. If still not satisfied, you then might seek out a specialist, but be warned that in many cases non-liver specialists also don't get treatment related side effects very well.

-- Jim
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Avatar_f_tn
I trust your advice explicitly, for I know you are well informed so I will call trial doc first and discuss the matter with him before doing anything else.
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Avatar_m_tn
As long as you have confidence in the credentials and experience of your trial doctor, he or she should be your point person in treatment related issues. That's how I handled things on treatment but it didn't mean I would not seek advice elsewhere if I felt another specialist might help or if I felt I needed more than one opinion. This happened with my psoriasis where I sought out several dermatologists and with my GERD where I saw both another gastro and an ENT. Of course, the treatment doctor has to deserve being point person meaning a liver specialist with a large, clinical practice who you have confidence in.

If not, then unfortunately it's either switch treatment docs or off to this and that specialist from the get-go which can make for a more confused and hectic treatment process. Of course, in your case, being in a trial, switching docs is out of the question. Good luck and hopefully everything will work out fine, and if you do see the trial doc try and get his email address for future questions. I found this very effective during treatment when I needed input between appointments. Hope things work out.

-- Jim
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Avatar_f_tn
When I got my Endocrinologist it was BECAUSE the trial team contacted my family doctor to ask for his assistance in getting a referral for me in my own area.  Because I lived 1-1/2 hour drive away from my trial centre, they worked closely with my family doc and the labs in my area to manage different aspects of my care so that I didn't have to drive to them for every blood test - which was great because I ended up needing weekly tests for pretty much the whole time I was on treatment.  When both my trial team and I agreed that the care from my local Endocrinologist was far below par, they arranged for an appointment with an Endocrinologist within THEIR vicinity and he's been great.  The key here is that everything went through the trial team.  If I got sick, I was to go to emerg at my local hospital and keep them in the loop.  Copies went to my family doc who would send them to my trial team.

If your trial nurse was upset, it MIGHT be because your family physician was attempting to treat you without enough communication with your trial team.  Best case scenario is that they work together.  I tried a "cowboy" move with my family doc once on something with which I was a bit out of synch with my trial team on and my family doc reined me in on that by saying if my trial team was good with it, so was he and he'd want their approval first.  Smart guy.  Like as if you go messing with someone's treatment when you don't know the first thing about treating Hep C.

I didn't even take a supplement without running it past my trial team - even my mushroom compound.  She had to record everything I did and keep reports on *everything* and she took it pretty seriously.  So I didn't mess her up and I did my part by keeping her in the loop.  I trusted her though and we had an excellent relationship.

Talk with your trial doc about your thyroid concerns and good luck.

Trish

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Avatar_f_tn
Sorry...if I got sick after hours I was to go to emerg ... normal things I could see my family doc when it was between my treatment appointments and he would communicate results with my trial team.  It's good your doc has talked with your trial nurse - they do need to communicate.  However, again .. arrange some face time with your trial doc.  It's amazing how much that face time with the doc can make a difference.  Sorry for going on and on .. just hoping you get this sorted out.

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Avatar_f_tn
Thank you Trish --that helped put things in perspective as to why the nurse was so upset.  Actually, it was me who instigated it by calling the private doc, and he went along with it.  So both of us made the cowboy move ( lol-- nice saying ).  I also knew I had to get it approved with the trial nurse by calling her.  I do not take ANYTHING without asking her first.

I will be contacting the study doctor first thing Monday morning and see what he thinks is best to do, and if he feels I need an endo I will ask for him to refer one.  One thing I want to discuss with him is testing my thyroid more than once a month, so it doesn't get so high like it is.  I understand they can't do it every week, but maybe twice monthly or every 3 weeks.

Like I said above my gastro lives and breath Hep C so I am sure he knows of a endo that deals with people with the virus, and understands all the complications the meds can bring on with the thyroid.

No more cowboy moves for me--it didn't go over well.  Lol !!!
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568322_tn?1370169040
Tippy:

High uric acid is not just associated with kidney stones and gout.  That would be the least of your problems.  High uric acid is associated with Glucose abnormalities (high uric acid causes insulin resistance), HIGH BLOOD PRESSURE, and renal disease (that means kidney damage).  

I don't know whether you remember that BklynBoy81, who is also in the same Telaprevir trial as you, recently developed high uric acid and HIGH BLOOD PRESSURE and his doctor had to put him on blood pressure medication.  

HIGH URIC ACID CAUSES HIGH BLOOD PRESSURE!!!!  And insulin resistance!!!  And the high blood pressure can affect the heart.  Here's a study that showed that .....

"People with Uric Acid levels between 6.6 and 11.0 had a significantly increased prevalence of Left Ventricular Hypertrophy (abnormal thickening of the heart muscle)."

http://www.ncbi.nlm.nih.gov/pubmed/19225200?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum



And here's a study that showed that treating the high uric acid with Allopurinol (the medication your doctor wanted to give you) lowered the high blood pressure without need for BP meds.....

http://www.ncbi.nlm.nih.gov/pubmed/11711505?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=5&log$=relatedarticles&logdbfrom=pubmed


Talk you your trial doctor and explain all this to him.  He can't let you continue having high uric acid levels that can cause so many problems later on.  

If I was you, I would somehow let him know that there's somebody else on the same Telaprevir trial who is also having high uric acid levels and developed high blood pressure.  I know that they discourage you from sharing any info on forums....but I think if he knew that this is not an isolated incident he would pay more attention to it.  

As for the trial nurse, she needs to stop getting personally offended because somebody went over her and consulted with their private doctor.  Patients have the right to do that!  And she's wrong!  Never have I seen a uric acid above 30 be left untreated on patients who were on HCV Tx.  It lowers SVR!

I swear, I would PAY to be able to talk to her for 5 minutes.

Co



Ammunition....I mean, sources:

"Uric acid is not a simple marker, but a cause of renal disease"

http://www.ncbi.nlm.nih.gov/pubmed/16361844?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=4&log$=relatedreviews&logdbfrom=pubmed


"Uric acid: bystander or culprit in hypertension and progressive renal disease?"

http://www.ncbi.nlm.nih.gov/pubmed/18854744?ordinalpos=8&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


"Uric acid and the development of metabolic syndrome in women and men"

http://www.ncbi.nlm.nih.gov/pubmed/18502269?ordinalpos=16&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


"Serum uric acid levels and risk of metabolic syndrome in healthy adults"

http://www.ncbi.nlm.nih.gov/pubmed/18463036?ordinalpos=17&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


"Relationship between hyperuricemia and metabolic syndrome"

http://www.ncbi.nlm.nih.gov/pubmed/18409529?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum


"A causal role for uric acid in fructose-induced metabolic syndrome"

http://www.ncbi.nlm.nih.gov/pubmed/16234313?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=3&log$=relatedarticles&logdbfrom=pubmed
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568322_tn?1370169040
Hey Tippy...

Tell your trial nurse (you know, the one that keeps saying everything's okay) that thyroid problems cause high uric acid!  


"More than 99% of primary gout cases are referred to as idiopathic, meaning that the cause of the hyperuricemia (high uric acid) cannot be determined. Primary gout is most likely the result of a combination of genetic, hormonal, and dietary factors. Secondary gout is caused by drug therapy or by medical conditions other than a metabolic disorder.  The following factors increase your risk for gout:

THYROID PROBLEMS"

http://www.umm.edu/patiented/articles/what_symptoms_of_gout_000093_3.htm


This is actually very good news.  A thyroid problem should be easy to fix.  

I feel sooooo much better.  I was really worried : )

Co
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