Fibromyalgia Clinical Study

Discussion in 'Fibromyalgia and ME & Chronic Fatigue Syndrome' started by susanmarie1, Jun 14, 2006.

  1. susanmarie1

    susanmarie1 New Member

    I usually don't post many messages, as I glean so much just from reading other's experiences. I was dx'ed with CFIDS/FM back in 1985. I have been seen by any doctor you can think of, especially a renown immunologist, here in South Florids. As of 2000, he was no longer listed as a provider on my insurance, so it's been a nightmare, with all of the different opinions from doctor's that don't know diddly. It's like re-living all the nonsence before I was diagnosed.

    The reason I was writing today, is that I heard a local commercial, recruiting FMS patients for a clinical study. The study is just getting off the ground, and it is being conducted by a Neurology Group. Upon speaking to the young lady that is in charge of the study, she told me that the double blind placebo study would be Effexor or not, which I was prescribed several years back. I had an extremely negative experience with this medication, as it was, for me, like taking speed. The head of the recruiting group said that if I had taken, I believe the XR instead of the SR (maybe backwards), that I would not be able to qualify for the study. OK, we went on, as I told her my paradoxical reaction that I had to this med. Somehow she felt that we could work around this. We then broached the subject, that I was on disability for CFIDS/FMS along with some other health maladies, that was the basic end of the conversation. If one was on any type of disability, that would disqualify them from the study completely.

    I was floored, to say the least! If one has been diagnosed with this awful disease, and looking for some light at the end of the tunnel, what gives? There are no more difficult hoops to jump through than going through the horrible beaucracy of obtaining Disability, and really, all I wanted out of this possible study, was some neurological testing, and some hopefully some relief.

    I'm sure this happened for a reason, but for the life of me, I can't figure it out. There is a solid diagnosis of FMS, and 26 years of suffering. Instead of the pain going into some remission, it is as bad or worse than it ever was.

    I guess these "double blind placebo studies" under the auspices of a clinical study for Fibromyalgia, is not what I thought it would be. This study will be taking place in Broward County, FL, and to say that I was disappointed in the way this was handled, is an understatement.

    Hopefully this study will help with others, but I really feel that being disqualified for being on Disability is almost discriminatory!

    Thanks for listening,

    Susanmarie1
  2. mollystwin

    mollystwin New Member

    Wow! I can't believe they disqualified you for being on disability. How very strange. BUt maybe it was not a bad thing.
    I have been hearing some very negative things about effexor and it's withdrawal effects. My SIL tried effexor for her fibro and she gained 30 lbs and it didn't help her fibro, so her dr took her off. He tapered her down over 4 weeks I think. She went into major withdrawal and had to go back on the low dose. She has been sick for about 6 weeks and is now bedridden for the past two weeks and may have to cancel her vacation because she is just so sick. I googled effexor and found that there are many who get sick trying to get off it. It;s the worst antidepressant for withdrawal and side effects.
  3. laura81655

    laura81655 New Member

    That seems strange that they would be targeting Effexor in this study since this drug has been around for awhile and it's not really prescribed for Fibromyalgia. Cymbalta, which is similar to Effexor is prescribed for fibro.

    Effexor also made me feel like I was on speed, and I have read some horror stories about people trying to get off of it too.

    Laura
  4. suzetal

    suzetal New Member

    A year ago I had applied for one got accepted.Before the study started I had to call and ask if I could start a few days latter than the date she had given me.

    She said sure because the study is on going and will go on for a few years.She than told me she needed to put down a reason .No problem I told her that I had a meeting with my attorney about my SSD case.

    That was it she told me I could not do the study.I asked her why.She told me that they did not want to jeopardies my ssd .That would leave them open for a law suit if they did.

    So that was that no study for me.I was bummed.:(

    Sue
  5. mollystwin

    mollystwin New Member

    are the ones who suggested my SIL to try effexor for her fibro. I have heard others on the board who have been prescribed effexor for fibro. I did a search when trying to find info for my SIL.
    I still dont understand the study not taking SSD candidates. Is it because the study might make them better and then they are denied benefits and they get sued? I'm not getting this?

    [This Message was Edited on 06/14/2006]
  6. puddin827

    puddin827 New Member

    I am starting the study with Effexor next week here in Missouri. I hope it works for me. It's Effexor with another drug in it. It isn't just Effexor. Has some long name and I don't remember it right now ,when I find it I will let you know. For short, I know it's DVS.
  7. puddin827

    puddin827 New Member

    Desvenlafaxine Succinate orDVS-233
  8. mollystwin

    mollystwin New Member

    Good luck with the study. Be very careful with the effexor, especially when you have to go off the drug. Taper very slowly for several months no matter what the drs tell you.
    I wish you the best.
  9. NyroFan

    NyroFan New Member

    SusanMarie1:

    I heard a similar commercial. I called and they set up a phone interview.

    Well, they called and on question was:

    Would I give up my pain medication during the nine month study and just use what they give.

    I said 'no'.

    They said I no longer qualified.

    nyrofan
  10. puddin827

    puddin827 New Member

    Yeah, I can't take anything else while I am on the study except for tylenol in low doses. My luck I will get the palcebo.
  11. susanmarie1

    susanmarie1 New Member

    Thanks for all of the feedback. One thing for sure, was that I knew that I was not going to take Effexor, however, I was not aware of it's potential withdrawal effects. I took it years ago, and I stopped it before I finished less than a week's dosage. I keep records of everything, but it must have been so long ago, that I would really have to dig to find my RX records from the year (very small part of) that I was prescribed this. I definitely have done some research on Cymbalta, and testimonials that it has helped with FMS, but there again, I've heard of tremendous weight gain.

    At any rate, I am grateful that I was more or less "booted" from the study. The reason was what angered me. A diagnosis of FMS could not possibly cause any liability with the government, unless, it cured me, which would make me no longer qualify for disability. That would be a "win/win" situation, as far as I am concerned.

    Thanks again for all of your responses!
  12. berrytired

    berrytired New Member

    I'm on it and feel great. Mind you in hearing of the withdrawls...I'm not looking forward to that once I do decide to go off.
  13. SusanChase

    SusanChase Member

    My suggestion for those who participate in clinical study, don't think the negative effects that you can get from it, besides think that you have a big part on that study to help you and other patients and be positive and trust your doctor.
  14. Mikie

    Mikie Moderator

    I think it's very generous of those who do clinical studies if they are wanting to help others; however, I would never do one. You don't know what you're getting and I don't think truth is a value the companies running these studies have. So many new drugs shortly show up to have some very dangerous negative side effects so, if it's a new drug, I think it's risky. Just MHO.

    Love, Mikie
  15. IanH

    IanH Active Member

    I am not sure whether you are distinguishing between clinical research and pure research. Clinical research does not have to involve drugs or even any treatments at all. 'The knowledge of ME is in its infancy so we have a lot to learn about the disease itself before we start looking at drug creation or treatments. Currently any drug treatments are just drugs borrowed from other diseases in order to amend symptoms and many of them are sledge-hammers. Their success is likely to be very limited and I suspect no better than nutritional supplements shown to help the main symptoms of fatigue, pain and disturbed cognition as well as managing activity carefully.

    If a particular virus or group of viruses is not found to CAUSE the illness then I am afraid we are in for a long haul so involvement in research is vital to help us understand the illness. There are three main aspects to understanding the illness:

    Firstly what are the biochemical abnormalities and their pathways right down to which genes are affected or causing the abnormalities? This will include the key "biomarkers" which can be used to diagnose. How do these abnormalities cause the symptoms we all have and why the variations?

    Secondly what is causing the abnormalities? Are single agents involved? Are they environmental? Which genes are involved and do they involve SNPs? Are behavioural factors involved and if so how do they affect the biochemical pathways, especially the neuro-immune factors that have already been found such as NKC abnormalities, epitope cross reactivity, protein synthesis abnormalities.

    Thirdly what treatments can be applied to alter these abnormalities? How can the disease be prevented? So like Mikie I am very skeptical of any drug treatments that are marketed at the moment. However people do need help to reduce their symptoms to a more manageable level.
  16. Mikie

    Mikie Moderator

    Thanks, Ian, as usual, you have broken things down in such a sensible way. Too often on these forums, people are convinced they have found the "cause" of FMS simply because they got sick following a viral infection or bacterial infection. My own CFIDS was "triggered" by a mycoplasma infection so I suspect there may be a relationship but not causation. I've always believed there is a genetic factor as well as environmental factors which come together in a "perfect storm" to trigger illness.

    On the other hand, the amino acid solution injections (formerly known as, peptide injections) stop the symptoms of our illnesses in individuals like me with plenty of receptors in the brain. Something involved in our illnesses prevents our bodies from making the correct sequences of amino acids to produce proteins which can perform their jobs in the body. The videos on protein shapes on You Tube is how I finally found out how these injections work. Even if someone isn't interested in the shots, these videos are very interesting and informative.

    BTW, my recent two bouts with the flu and my ongoing UTI's really made me run down and I was getting some returning symptoms of arthritis, fatigue, aches and dry mouth. I took a "booster" injection and immediately started to feel great. Don't know whether I'll need another--hope not. They cost as much as a car payment. Still, I'll be happy to continue to drive my 11 year old car if I can feel this good.

    Thanks again.

    Love, Mikie