Drugs nearing approval for mysterious pain condition (Fibro)

Discussion in 'Fibromyalgia Main Forum' started by JLH, Jan 8, 2007.

  1. JLH

    JLH New Member

    Source: Reuters
    Date: January 8, 2007
    Author: Lewis Krauskopf
    URL: http://www.boston.com/news/nation/articles/2007/01/07/drugs_nearing_approval_for_mysterious_pain_condition/?p1=MEWell_Pos5

    Drugs nearing approval for mysterious pain condition

    NEW YORK (Reuters) - Not all doctors are sure about the pain and fatigue
    condition known as fibromyalgia, but drug companies are racing to win U.S.
    regulatory approval to serve this potentially lucrative market.

    The sometimes-debilitating disorder afflicts an estimated 2 percent to 4 percent
    of Americans, mainly women. But diagnosing fibromyalgia is not easy because its
    cause remains unknown and its symptoms, which also include depression, can
    overlap with other conditions.

    With no test to confirm fibromyalgia, doctors rely on patient complaints of
    symptoms and subjective responses to physical exams. As a result, some
    physicians are wary of viewing it as a distinct ailment.

    Still, a who's who of pharmaceutical companies - including Pfizer Inc., Eli
    Lilly & Co., Forest Laboratories Inc. and Wyeth - are looking to seize on a
    market now dominated by older anti-depressants as well as painkillers and other

    "What they're thinking is: This has a huge, untapped, unmet need," said Maria
    Marzilli, an associate analyst with market research firm Decision Resources.
    Decision Resources expects sales for drugs used for fibromyalgia to roughly
    triple to at least $1 billion by 2014.

    The companies are vying for the first clearance by the U.S. Food and Drug
    Administration for a fibromyalgia treatment, which could occur as soon as 2008.

    Doctors can prescribe medicines for fibromyalgia even though the drugs are not
    cleared specifically for it. However, without FDA approval, companies cannot
    promote the drugs as treatments for that condition.

    Therefore, even though doctors already may be prescribing Pfizer's Lyrica and
    Lilly's Cymbalta for fibromyalgia, positive clinical data and U.S. regulatory
    approval for that use could jump-start sales. "This is a nice way to tack on
    $200 to $300 million more in sales," Marzilli said.


    An FDA approval could also quell doubts about the disorder's legitimacy, while
    paving the way for companies to promote medicines specifically for fibromyalgia.
    To be sure, doctors and consumers will hear more about the condition as the drug
    makers rev up their powerful marketing engines, possibly sparking more
    widespread diagnosis.

    "If the FDA approved a drug for fibromyalgia, that would really give the field
    validity," said Richard Harris, a molecular biologist and research investigator
    at the University of Michigan who recently published a data review of

    In most cases, the companies are conducting clinical trials in fibromyalgia for
    drugs already approved for other conditions. Lilly, Forest and Wyeth have said
    they are testing anti-depressants that regulate two brain transmitters,
    serotonin and norepinephrine. Pfizer is testing a drug cleared for epileptic
    seizures and neuropathic pain.

    As classified by the American College of Rheumatology in 1990, a fibromyalgia
    diagnosis involves a patient feeling muscle tenderness in at least 11 of 18
    predetermined sites on the body, with the pain spread throughout the body.

    Fibromyalgia patients also tend to tire easily, struggle to sleep and have
    trouble remembering things, a problem referred to as "fibro fog." But patients
    often receive other diagnoses before their doctors decide they have fibromyalgia.

    Lynne Matallana, founder and president of the Orange, California-based National
    Fibromyalgia Association, was an advertising executive and avid skier and
    bicyclist in the early 1990s until she began experiencing widespread pain and
    fatigue that left her bedridden.

    She said she had seen 37 doctors and received diagnoses of lupus, rheumatoid
    arthritis and depression before a physician finally identified her condition as
    fibromyalgia. "It's devastating because it is totally life-altering, and many,
    many, many people find themselves in this situation," Matallana said. She added
    that she gradually improved through exercise, meditation and medication.

    Review Results

    In their review, Harris and a colleague at the University of Michigan reported
    evidence of increased neurological responses to pain, indicating that the
    central nervous system of a fibromyalgia patient processes pain differently.

    Traumatic events - such as a car accident - may trigger the condition. Matallana
    said her fibromyalgia flared up after she underwent surgery for another ailment.
    "I think that some physicians do believe that fibromyalgia isn't a real
    condition, and our job to spread the word that there are objective findings that
    these people are in pain," Harris said.

    But Dr. Scott Zashin, a rheumatologist in private practice in Dallas, says
    fibromyalgia is one of the more common conditions he sees. Zashin says he
    usually tries to get fibromyalgia patients to exercise more or get more rest
    before turning to medication. "These patients seem to have an increased
    sensitivity to pain," Zashin said. "Something in their makeup makes them
    experience pain differently."

    (c) 2007 Reuters

  2. nightngale

    nightngale New Member

    Maybe finally someone (including my own FAMILY members )wont' say "What's fibromyalgia" like I'm crazy in the head! Seems like a lot of new stuff is being found out this year alone!
  3. Mwitherite

    Mwitherite New Member

    Before I knew what I had and that this FM actually existed I used the Princess and the Pea to describe to my friends and family how I felt and hurt. Usually including the words "only worse". I have actually reffered my mom and pop to the library page for FM in this website so they could see for themselves that I am not the only one with Princess and the Pea Syndrome and that it is actually called Fibromyalgia and IT IS NOT ALL IN MY HEAD. Awareness is the key to less suffering and a shorter diagnostic period. I am putting a description of this syndrome and some of it's symptoms on my live space just so I can at least improve awareness of the people that care to visit and also that link you see in all the posts.

  4. fivesue

    fivesue New Member

    It sounds promising, doesn't it? Some hope on the horizon is a big boost for me today. Very sore, etc.

    So, again, thanks. I appreciate the time you took to give us this info.

  5. ephemera

    ephemera New Member

    Read this part again (clipped below) before rejoicing. Lots can happen to any testing between now & 2008. What do you give as odds that the first clearance will be for another anti depressant.

    "What they're thinking is: This has a huge, untapped, unmet need," said Maria Marzilli, an associate analyst with market research firm Decision Resources.
    Decision Resources expects sales for drugs used for fibromyalgia to roughly triple to at least $1 billion by 2014.

    The companies are vying for the first clearance by the U.S. Food and Drug Administration for a fibromyalgia treatment, which could occur as soon as 2008.

  6. leubie

    leubie New Member

    hey thanks for the info-------------i only hope that this is it------------but---------well-----------i agree w/ wake-------is this just more of the same old same old????-------i too feel that we all have suffered too much--------it is time for the medical world to offer us some solid help!!!-------this is just my opion---------------love to all----------laura
  7. JLH

    JLH New Member

    I, too, think now that they see they have such a large market for fibro treatments, that there is a rush to get some drug on the market "just for fibro". I hardly think that they could research it appropriately in one year and have a drug to help it on the market by 2008--which is just next year!
  8. Wolverine

    Wolverine Member

    The article is NOT about a wonderful new breakthrough drug, is it? No, it's merely stating that so many people now have fibro as it is becoming more widely recognized, that all the companys want to "get in on that untapped need"

    So yes, my guess is that they will just be making current drugs such as cymbalta etc "approved treatments" for fibromyalgia. Therefore anyone with CFS or fibro symptoms will be dished out these drugs much more easily and without concern, because they are now 'approved.'

    My interest will be when there is a worldwide article on a huge new breakthrough treatment for CFS / FM that is proven to work! Not simply 'there is a huge market out there for fibro people to buy our drugs', just because it is a 'new illness' (or new to wide recognition anyway.

    When that treatment comes out and i see breakthrough results, ill be impressed. But until then i don't put huge hope on anything anymore, except my own steady efforts.

    Take care all. ~Chris.

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