Will not be a guini pig at research clinic;update

Discussion in 'Fibromyalgia Main Forum' started by mrpain, Jul 26, 2006.

  1. mrpain

    mrpain New Member

    On the radio they've been advertising about fibromyalgia and how they need participants who qualify. I finally called and past their pre-test to see if I qualified (which I did)...and now I'm going down to meet the staff on August 1st, and have all my questions answered.

    This is a first for me, and I know if I except this experiment with the research clinic, it will involve me with giving up what I'm on now, to try their new pain medication. It's something new on the market, and it will be for 9 months.

    Has anybody here been thru something like this before, and what was your experience?? Would you recommend it? The one thing I'm concerned about is being in the group that gets the placebo,(sugar pill)...How do you manage the pain in that case?? Any help or advice would be very appreciated!
    One other thing also..This trial is only for pain. It does not address the other symptoms such as fatigue, brainfog, ibs, lack of sleep, cognitive impairment, panic attacks, anxiety, or chemical sensitivety. Only pain.
    [This Message was Edited on 08/01/2006]
  2. mme_curie68

    mme_curie68 New Member

    Read your informed consent document CAREFULLY.

    It will explain the risks and the potential benefits. Read your risks section VERY carefully.

    You will be randomly assigned to receive either the study drug or the placebo, then, halfway through the study, you will be washed out with no drug or placebo and then switched to the opposite of whatever you were first assigned.

    If you don't tolerate the treatment well, you always have the option of withdrawing from the study, but then you will lose the "compensation", free medical care, and potential access to the new drug.

    Clinical trials are big business. If you go into this with humanitarian ideals you will be sorely disappointed. Keep your eyes open and your feet on the ground and you should be okay.

    Most importantly, if you don't feel right, do NOT let the clinical staff pressure you into remaining in the trial at the risk of your own health. FM is a complex disease that often requires complex treatment - pain is just part of the picture.

    Best wishes.

    Hugs,
    Madame Curie
  3. mlrarr

    mlrarr New Member

    Hello,
    I knew someone who went on this "expermental" thing once. It was the same drugs they use for cancer!!! She died within seven months. She was in so much pain!! Although she was not in a "study" her doctor in his own mind told her he had read this new procedure thast he wanted to try on her. She was so tired of the fibro and cfs that he could of told her to do anything and she would have done it. Im all for modern meds but not at the price of what could be my life.
    Please read all information. You do and Im sure "they dont know" what the long term affects will be for taking this new drug...
    Melinda
  4. mrpain

    mrpain New Member

    What do you mean when you said it was big buisness? I'm curious to know how they make their money which would give me some insight.. My first thought when you said that was, that the drug company must pay the clinic hugh amounts of money to push that particular drug. Am I close? Am I even in the ball park??
  5. mrpain

    mrpain New Member

    When I go Aug. 1st I'll watch and listen very closely to see what exactly they are doing. I'll probably reject their offer, but will see what it's all about..Thanks!
  6. findmind

    findmind New Member

    Been wondering where you were...know now.

    I wouldn't do it. They don't care about you, your illness, your pain.

    They only care about getting a drug approved. Sure the drug company is paying the researcher or related hospital/clinic big bucks.

    As Stormyskye said, you could be doing positive things to help yourself instead. And unless you have a very high pain tolerance and know you can go without all your "help", whatever it is, you could go into a flare that will be awful, causing you to have to drop out anyway.

    Whatever you decide to do, best of luck in it, and let us know how you are, ok?

    There's always hope!
    findmind
  7. mme_curie68

    mme_curie68 New Member

    Yes.

    In the drug industry the organizations that "manage" clinical trials on behalf of a drug company are called "CROs" or "Contract Research Organizations" - they may handle some or all of the pieces involved in a human clinical trial, such as study site and investigator recruitment (hospitals and doctors - who are paid to conduct the research),

    patient recruitment (who are paid to participate in the study),

    trial monitoring (people who are theoretically paid to ensure that a trial is conducted ethically and according to FDA rules and regulations governing the use of human experimental subjects)

    sample analysis (the sites that test the blood, urine, feces, etc. collected from the study patients)

    biostatistics (the people that crunch the numbers to produce the results of the studies - and numbers can be crunched in VERY creative ways - called "subset" analysis.

    A small clinical trial, say one facility, 28 patients, double-blind crossover, for a generic drug versus a brand to compare bioequivalence - that may cost about 250,000 dollars U.S. and up, depending on the patient population you need.

    A Phase III, multi-center, clinical trial - thousands of patients you are talking hundreds of millions of dollars that will be paid out - so when I say big business, yes, I mean really big business.

    Does this mean that any doctor who agrees to participae in a clinical study is a greedy good for nothing who doesn't care about his/her patients? No. I'll give you my own personal example -

    I have a tumor in my liver. When it was first discovered, the doctors weren't sure whether it was benign or not. They THOUGHT it was benign, but again, a little bit of doubt.

    I was offered the option to participate in a clinical trial for a new MRI contrast agent for liver tumors - the data they had on this agent thusfar (and I got to look at the data) indicated that it "lit up" benign tumors in a specific way and cancerous tumors in a completely different way.

    Participating in the clinical trial got me extra reassurance that my tumor was benign, extra imaging, extra review of my images by extra radiologists for the small risk of a one-time injection of this agent in a world-class Boston hospital - my doctor was able to complete the enrollment he needed for the "control" patients for his study.

    So it's not always a bad thing, but it IS big business, don't let anyone tell you different. People have died participating in clinical trials.

    Here's a link to a very famous case from 2001:
    http://www.hsph.harvard.edu/bioethics/archives/200106/msg00001.html

    My biggest concern for you is that you would have to forgo all other treatment just for the chance of one drug that you may not even receive for 4 months, just for pain.

    Is it worth all of that?

    Hugs,
    Madame Curie
  8. mrpain

    mrpain New Member

    Well that settles it for me. Thanks for taking the time to inform and educate me on this subject. Also thanks to everybody else also. I was going into this without a clue so that's why I came here to people who will tell me the truth with no alterior motive... Thanks so very very much!
    Ya'll are the best..
  9. NyroFan

    NyroFan New Member

    mrpain:

    I also have heard that commercial, but did not pass the pre-test when I called. The question that disqualified me was: Would you be willing to give up what you are on now?

    I said 'no'. I was told immediately I did not qualify.

    I had the same worries you have. I will be intereted in reading your responses to this.

    nyrofan
  10. mrpain

    mrpain New Member

    I agree with you and all the others. The more I think about the whole situation, the more I am convinced not to do it. Like you, I couldn't give up my meds. for some sugar pill... I would hate to be penalized for dropping out....I don't want to put something that's not approved in my body to be a guinea pig. And I don't want to possibly stand the risk of suffering more and even possible
    death..

    With all that said, I'm still going to the office to hear what they have to say just to get clarity from their side and to chalk the visit up as a learning tool. I can decline after that if necessary. If for some reason I were to except, it would be because the offer was to good to pass up and was to beneficial for my health. But it would have to be in writing and I would have to have an out clause........
  11. rockgor

    rockgor Well-Known Member

    I read in the supermarket line, the people who do this testing are new to it.

    They used to be aliens who inserted anal probes, but now they've moved up to better-paying jobs.

    The good news for those getting tested is, you can lie down on the job.


    Serially, MrPain, I'm much too chicken to participate.
  12. springrose22

    springrose22 New Member

    Will look forward to your report about your August 1 visit. Should be interesting. Take care. Marie
  13. mrpain

    mrpain New Member

    OK; This will be the last of this thread but I do want to thank everyone for their advice and information. I felt like I was armed with some info when I met the staff today.

    Bottom line is that they were looking for fibromyalgia patients who suffered with pain, to try this new snri. Not a ssri, but a snri. It's a new kind of antidepressant which I had no interest in trying what so ever.

    They wanted me to give up everything I was taking with the exception of tylenol for the 9 month period. And yes that meant being on a placebo part of that time. She said I could drop out at any time with no penalty, but that didn't persuade me. She was a rn with a very caring and positive attitude, assuring me nothing would go wrong and that they had people to call if it did and all cost would be on them. Still wasn't persuaded. Thanks to all!
  14. tansy

    tansy New Member

    Source: http://www.timesonline.co.uk/article/0,,2087-2291800.html


    note - "Professor Richard Powell, an expert in immunology at Nottingham
    University: auto-immune diseases range from lupus to MS, from
    rheumatoid arthritis to ME."



    The Sunday Times July 30, 2006

    Renewed ordeal of the Elephant Men

    David Leppard

    NAV MODI fears he may have only two more years to live. The
    24-year-old from Forest Gate, east London, has just graduated from
    university and was looking forward to a career in his family’s
    electrical business.

    Now his future is uncertain. “It’s a really bizarre feeling when you
    discover you might be dead in a couple of years or even in a couple of
    months,” he said.

    Modi is one of the “Elephant Men” who nearly died last March when he
    and five others took part in a drugs trial at Northwick Park hospital
    in northwest London.

    Modi and his fellow patients were left seriously ill during the trial
    of the TGN1412 drug. His head swelled up like a balloon and he
    suffered multiple organ failure.

    Ryan Wilson, 21, another guinea pig, suffered gangrene that made his
    toes and fingers go black. All his toes and three of his fingers will
    have to be amputated; he had heart failure, kidney failure, pneumonia,
    septicaemia and liver failure.

    Mohamed Abdelhady, 29, a bar manager, suffered severe head and chest
    swelling. He was so bloated that his girlfriend Myfanwy Marshall said
    he was unrecognisable.

    The patients had volunteered for the trial after being lured with the
    offer of £2,000 each to test the drug made by TeGenero, a newly formed
    German drug firm. Parexel, the American firm that administered the
    tests, told them there would be no serious side effects.

    On March 13 this year, Modi and the other five patients were injected
    with TGN1412 while in the Parexel drug testing suite at Northwick
    Park.

    At first, Modi recalled last week, he did not notice anything. But
    then a horrifying sequence of events began to unfold: “It started
    about 40 minutes later with a headache. A couple of minutes later that
    turned into a severe headache.

    “It was like a huge, heavy foot was being pressed down on my head. I
    started moaning and crying, but the doctor just told me to calm down.
    He said it would go away. I begged him to do something. I told him the
    pain was killing me.”

    Modi then developed a back pain so severe that he was unable to lie
    down. “I was in such agony, I was jumping up and down on the bed and
    screaming.” All around the other patients were going through similar
    agony.

    Modi began retching, fainted, then stopped breathing; he was in and
    out of consciousness. Nurses tried to put an oxygen mask over his
    mouth but he kept pulling it off to be sick. The doctor gave him a
    paracetamol tablet. “I vomited that out in a couple of minutes.” Soon
    afterwards staff administered pain-killing sedatives.

    Modi woke up in the intensive care unit later that day. The next day
    he was visited by his girlfriend Divya Vegda, 22. Horrified by the
    sight of his swollen head, she later described him as looking like an
    “Elephant Man”.

    “My whole body was swollen up, puffed up like a huge balloon,” said
    Modi. “It was like they had pumped gas into me.”

    Four months later he still suffers from occasional lapses of memory,
    severe headaches, back pain and diarrhoea.

    He and the others had been led to believe that while their symptoms
    might persist for a while, their long-term future was not at risk.

    However, a study by Professor Richard Powell, an expert in immunology
    at Nottingham University, has changed all that. Last week Modi
    received the results of Powell’s medical tests, commissioned by his
    lawyers to establish the extent of the damage the drug has done to
    him. The assessment has left him in a state of shock.

    “The doctors told us we would be all right. They said they thought
    that in six months’ time we would be normal,” he said.

    Martyn Day, the lawyer representing Modi and three of the other
    patients, showed them Powell’s findings last week. “They face a
    lifetime of contracting cancers and all the various auto-immune
    diseases from lupus to MS, from rheumatoid arthritis to ME,” he said.

    With auto-immune diseases, the body attacks itself by mistake.
    Ironically, this is the type of condition the drug was being developed
    to treat.

    Modi was the only patient last week willing to speak about Powell’s
    study, which was based on detailed tests on their blood samples.

    According to Powell, Patient A has developed signs of cancer: “It is
    highly likely (more than 50% chance) that A will develop auto-immune
    diseases and has definite early signs that a lymphoid malignancy is
    developing.” This is a cancer of the lymphatic system that grows
    aggressively and will lead to death if left untreated.

    Powell said Patient B had more than a 75% chance of developing
    auto-immune diseases. A split in his cells could possibly indicate an
    early sign of a lymphoid malignancy.

    Modi’s prognosis is equally worrying. Summarising the medical report,
    Day said: “It is highly likely that Nav will develop auto-immune
    diseases. His (cell analysis) may be an early sign that a lymphomatous
    process (tumour growth) is developing.” Powell said Patient C was in
    the same situation.

    The problem for all four, according to the report, is the depletion of
    T cells. A shortage or dysfunction in T cells can lead to destruction
    of the immune system, meaning the body cannot fight diseases.

    Having studied Powell’s results with his clients Day said: “They were
    devastated, particularly the client who faces the prospect of an early
    cancer.”

    Last Friday Powell produced further results that confirmed T cells
    could not be detected in the four patients.

    When news of the disaster broke, TeGenero admitted liability. But it
    has since gone into liquidation and its insurance cover is worth only
    £2m, payable if court proceedings are not pursued. The company, set up
    for the purpose of making the drug, is not worth suing.

    Modi reserves his greatest anger for Parexel, the American
    pharmaceutical services company. Its revenues are expected to be
    nearly £400m next year.

    “They are supposed to be experts, but on the day of the trial they
    didn’t seem to have the expertise. They gave me paracetamol when they
    should have given us steroids. That would have made a lot of
    difference. I would not have suffered so much. Parexel should be
    banned from further clinical trials. They nearly lost the lives of the
    six of us and could still do so.”

    Modi alleges that the company is trying to avoid responsibility for
    the fiasco. He and the others have received £10,000 in interim
    payments from TeGenero’s insurer.

    In a report two months ago, the Medicines and Healthcare Products
    Regulatory Agency highlighted procedural errors, accusing Parexel of
    keeping incomplete records. But it cleared the firm of causing the
    disaster, saying the reactions to the drug could not have been
    predicted.

    Lawyers said the report was unsatisfactory. They have written to
    Parexel saying they hold it liable for damages as a result of its
    negligence and breach of contract. According to Day, Modi and the
    others may be entitled to between £2m and £5m to compensate for loss
    of future earnings and the cost of future medical care. Even if the
    case proceeds, Modi knows he may not live long enough to benefit from
    any payout.

    “I have made the biggest mistake of my life,” he said last week. “I
    feel like I’ve given away my life for £2,000. None of us is sure about
    the future. It could be that in six months’ time we are dead.”

    Parexel did not respond when asked to comment.

    Additional reporting: Anna Mikhailova

    [This Message was Edited on 08/01/2006]
  15. Cinlou

    Cinlou New Member

    Mrpain,

    You just never know what may happen.... I have a friend that was on a clinical trial for a new anxiety medication...well it totally messed her up big time! She ended up getting disability from the doctor that was doing the trial...she was getting the med...did not get the placebo....got very sick....

    Cindy
  16. mrpain

    mrpain New Member

    Has any of these deaths or injuries ever made the news? I don't ever recall seeing this reported unless it was on something like 60 minutes show.