This Is MS Multiple Sclerosis Knowledge & Support Community
Welcome to This is MS, the leading forum for Multiple Sclerosis research and support. Join our friendly community of patients, caregivers, and researchers celebrating over 20 years of delivering hope through knowledge.
My experience is, they will not answer these questions. I asked these same questions. I asked to see my MRIs. Even when the study is over, they will not give you specific information. Only the general results of the study.
Tim,
Thanks for that info. I kinda' figured that they would not divulge that information. Unlike when you go to your regular doctor and are paying for your care and treatment, we study enrollees are not paying for the treatment that we receive and therefore do not own the information. So, since Opexa is paying and are the owners of the info they only have to release the info that they want to.
Hi Mike,
Expanding on what Tim said, clinical trials cost millions of dollars. I can't blame them, Opexa wants to see good results from the trial.
If Tovaxin is as effective as it seems to be, making you aware of your changing mrtc count would be the same as unblinding the study. While awareness of the mrtc count might elate those on the actual treatment, there would probably be a number of people who would drop out of the study upon realizing that their mrtcs were unchanged with the assumption that they weren't getting the real thing.
I'm not an expert on clinical trials but I think even the people who quit the trial factor into the final results in some way so having a few, or everyone on placebo quit before the trial is over would skew the results of that expensive clinical trial, maybe making it worthless to present to the FDA.
ok...I can see that telling ppl about thier levels when they are still in the study is not right. However, once the study is done, patients (i think) should be able to know what happend to them. Yes Opexa is spending money to develop this drug but these ppl are taking risks in order to make it possible for Opexa to develop a vaccine and make money off of it. We in turn get a better choice. Just saying that at the end, you should be able to get your results...besides...what if there are side effects and you need to know what they did to you later on???
NN
sh8un wrote:Just saying that at the end, you should be able to get your results...besides...what if there are side effects and you need to know what they did to you later on??? NN
I think some of the paperwork that people entering the trial are required to sign is their agreement that all test results Opexa pays for are the property of Opexa.
In my wife's case, signing up for the clinical trial didn't affect her schedule as far as her normal neuro visits so her normal channels will still be open.
I'm not a lawyer but I imagine if you had a legitimate concern about health issues you could probably get a court order or something.
Isn't that situation a little similar to Tysabri? I can't remember for sure but didn't the company keep PML quiet for a little while? I wonder what finally brought the situation into the open?
Hi Lyon,
Your easy university life amongst all those chemicals has clearly addled your brain! I agree 100% with sh8un. Trial participants should be entitled to their medical records, post a trial. None of the current MS drug trials are so wonderful that participants shouldn't lobby for greater access to this information, at the commencement. In fact, my neuro has told me that trial participants for RR drug trials are hard to come by. SP & PP participants are far more readily available. This should give, particularly, RR drug trial participants a fair degree of pre-trial leverage.
Regards,
Phil.
Hi Phil,
Don't get me wrong, I agree that trial participants "should" get their records, or copies of their records after the trial and I can't say that if/when Tovaxin is officially on the market that Opexa won't let people have copies of their records.
It also is true that Opexa is paying for all these tests and people entering the trial knowingly signed letters of agreement so it's not like Opexa is trying to pull a fast one.
I know that it used to be hard to find RR registrants for clinical trials. In this case it would be interesting to know how many people have tried to enter this Tovaxin trial. Because of expected 50% mrtc isolation rate Opexa is going to have to cycle AT LEAST 300 people through to find 150 which test positive.
This is a later edit. It also comes to mind that from Opexa's standpoint it's a lot different to have your competitors read that Tovaxin was 92% effective in a clinical trial and leave them with some doubt as compared to handing the participants their personal information after the trial and leave themselves open to a competitor later buying those results from the participants and having proof on paper. I don't want to instigate a good pharma/bad pharma discussion but MS is a multi-billion dollar industry. Giving the big guys proof on paper that you're soon going to be in control of their cash cow just doesn't seem like a wise thing to do.
I think we all agree that patients should have access to their specific study data, but no one is forced to enroll in a study. In fact, the patient is given every opportunity to drop out of the study. You don't even need a reason to withdraw from a study.
In any study, patient data is combined to get an overall evaluation of how effective the treatment is. I do not have a name in the study. I am a series of 6 numbers and letters. By entering the study I gained the possible benefit of the treatment but gave up having access to specific data about myself.
Since my EDSS had gone down, my father wanted copies of my MRIs so that he could have them analyzed for changes. He could not get them. That was a good medical reason, but not a medical emergency. If there were a medical emergency, there probably is a way to recover specific patient data. Knowing your MRTC status is not a medical emergency.
People in the Tysabri study had a true medical emergency. Three people taking Tysabri contracted PML, and two died. About 3,000 patients had taken the drug before it was recalled.
I just reread the 10-page form that I signed to be in the study. There is an experimental subject's bill of rights, but it says nothing about having access to my personal data. My informed consent agreement to be in a research study states "records of you being in this study will be kept confidential except as required by law". It goes on to say with whom the data will be shared, and I am not on the list. I assume if there was a legal reason to see my records, there is a legal process by which I could obtain them. The key issue would be demonstrating that there was a legal reason.
The FDA requires strict adherence to the protocol approved for the study. The company is not allowed to deviate from that protocol without written permission from the FDA. If you are interested in being in this or any other study, you will be given a lengthy consent form to sign. Read it carefully and if you do not agree with all of the conditions, walk away.
Best regards, Tim
In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
Ok...so, the company does get informed consents signed by the enrolees but i think it's still wrong for them not to give you your own test results. I mean, any MSer is hoping for a cure or better treatment. In reality some ppl will sign the forms even if they don't agree with all of it just because they are desperate to get into the trial. It just eriks me to use ppl like that. Ppl are willing to do anything to get ride this awful illness and I think that Opexa should do all that it can to ease their minds...but then again, I am not stupid enough to think that Opexa is ONLY about helping ppl. Just because you sign a piece of paper does not make it fair. They should not be asking you to wave your rights to your medical records.
NN
I can only comment on the Tovaxin trial because that is the only one that my wife decided the cost/benefit ratio was good enough to enter.
Despite the number of people who have been on Tovaxin in its different forms, no side effects have shown themselves and there are no obvious reasons to expect side effects, yet it seems to be really effective.
In my wife's situation Opexa isn't really withholding any information that she might have had the opportunity to find out if she hadn't entered the trial. She's still going to her regular neuro who will continue taking periodic MRI's and watch her disease progress-or not. Counting mrtc's is not something her neuro is capable of so we wouldn't been aware of those numbers otherwise.
The only down side for my wife is the year that she might have to be on placebo, but considering how early and how mild her MS has shown to be so far that was a risk we took knowing that she would for sure be on Tovaxin the year after.
For us, considering what she stands to gain compared to what she's giving seem like a favorable ratio. She tells everyone who will listen how lucky she was to have gotten into the trial and I've seen no evidence that she feels that anything is unfair about it.
I do see your point but if an adult of sound mind enters a situation and willingly accepting the terms, it doesn't seem that there is anything unfair about it.
My experience so far in the trial has been that the only thing they share with you is the lab results from your blood draw. Just the type of stuff you would get from doing bloodwork for a physical. You know the cholesterol, triglycerides and all that.
I asked my Dr. about my MRI since I've been such a neurotic Nancy lately and he told me that he doesn't get to see them. They are Opexa's. All this is for some of the stuff that Bob said a few threads back in this post. The fear of unblinding and skewing the study is huge since they obviously want to take this drug to market. When it comes down to it, it's not very compassionate since we are alll hurting and curious about what's going on with us, but in reality, when you are in a trial you really are a guinea pig in the pure sense of the word.
I did find out one thing though. I have been having a real rough go of it with my eyes lately. My trial nurse and research coordinator are concerned so they talked about me going to one Dr. that they said was unblinded. He doesn't work in my neuro's office, so there is someone who knows, but I don't know if talking to him would take me out of the trial since I would now know and that would really screw the trial up.
I think the cold, hard fact is that if you are in a trial, all the testing and stuff that they do to you is the company's property period. We did have to sign many releases to that effect and that stuff is so official that if they change ANYTHING you have to sign another 20 page document. I'm talking address, typos, anything. It's incredible how much they have to cover their ass to do one of these. I have resigned myself to it and am OK with it all since I do understand that the intent is to not have to do it over and potentially not have enough $ to do it.
Loobie wrote: I did find out one thing though. I have been having a real rough go of it with my eyes lately. My trial nurse and research coordinator are concerned so they talked about me going to one Dr. that they said was unblinded. He doesn't work in my neuro's office, so there is someone who knows, but I don't know if talking to him would take me out of the trial since I would now know and that would really screw the trial up. Lew
Hi Lew,
I have no firsthand knowledge and this is all just guessing to try to make some sense of the situation.
It seems that since Opexa had to test at least two people to come up with you, a person who tested positive, they have a lot of time and money invested in you. It could be said that they want you to drop out less than you want to drop out and I think it's safe to say that they will probably go out of their way to work the situation so that you don't have to drop out.
Considering they recommended this unblinded doctor it seems they might have some safety mechanism in place so that he can resolve your problem without unblinding you. I have no idea what that could or would be other than determining exactly what your situation is and treating it accordingly while somehow not hinting to you whether you are on treatment or placebo.
Me personally? I'd go to that doctor for curiousity reasons if nothing else. As a layman, I don't see how treatment options differ much for the specific problem you are facing regardless of whether you were participating in the trial or not.
If you form the view that the trial that you are invited to participate in is so very good that it doesn't matter too much that you know exactly what has happened to you whilst on the trial then it would seem reasonable not to press for your medical records at the trial conclusion.
On the other hand, if you believe that there is some chance that the trial will not fulfil your hopes and expectations, it would seem prudent to me to be able to have access to your trial results in order that you can properly take personal control of the situation and carry on your individual fight against MS with the full knowledge of where you have been.
On the other hand, if you believe that there is some chance that the trial will not fulfil your hopes and expectations, it would seem prudent to me to be able to have access to your trial results in order that you can properly take personal control of the situation and carry on your individual fight against MS with the full knowledge of where you have been.
Hi Phil,
I can't argue against that other than to agree with Lew earlier in that to enter these trials you really do have to accept that they aren't entirely fair to the entrants. Regarding the entrants, you really have to find out everything you can about the treatment and like what you see and be willing to accept the risk of the placebo arm. No doubt, it could be a dangerous gamble.
It sounds like kind of a heartless situation but realistically the purpose of clinical trials isn't specifically to improve the condition of those entering the trials but to determine whether a treatment is safe/whether it provides benefit/what degree of benefit over placebo.
At this point it's not known that Opexa won't release the results to the patients after the trials are over so this all might be a moot point.
I agree 100% with sh8un. Trial participants should be entitled to their medical records, post a trial. None of the current MS drug trials are so wonderful that participants shouldn't lobby for greater access to this information, at the commencement. In fact, my neuro has told me that trial participants for RR drug trials are hard to come by. SP & PP participants are far more readily available. This should give, particularly, RR drug trial participants a fair degree of pre-trial leverage.
